Patent Application
20190046794
In an aspect, a neural stimulation system includes, but is not limited to, a neural signal sensor adapted to sense a neural signal from a subject, the neural signal indicative of a physiological status of the subject, a neural stimulator adapted to produce a stimulus responsive to the sensed neural signal, the stimulus configured to activate at least one sensory nerve fiber innervating at least a portion of a pinna of the subject, and a securing member configured to secure the neural stimulator to the pinna. In addition to the foregoing, other system aspects are described in the claims, drawings, and text forming a part of the disclosure set forth herein.
In an aspect, a method includes, but is not limited to, sensing with a neural signal sensor a neural signal indicative of a physiological status of a subject, the neural signal sensor located in or on a portion of a body of the subject, determining with signal analysis circuitry at least one parameter of the sensed neural signal, and delivering a neural stimulus with a neural stimulation device worn on a pinna of the subject responsive to the sensed neural signal, wherein the neural stimulus is configured to modulate the activity of at least one sensory nerve fiber innervating at least a portion of the pinna of the subject. In addition to the foregoing, other method aspects are described in the claims, drawings, and text forming a part of the disclosure set forth herein.
A wearable neural stimulation device includes, but is not limited to, a vibratory mechanical stimulator adapted to produce a vibratory stimulus of sufficient frequency and amplitude to modulate the activity of at least one mechanoreceptor with a receptive field on at least a portion of a pinna of a subject, and a securing member configured to secure the vibratory mechanical stimulator to the pinna. In addition to the foregoing, other device aspects are described in the claims, drawings, and text forming a part of the disclosure set forth herein.
In an aspect, a method includes, but is not limited to, delivering a vibratory mechanical stimulus to at least a portion of a pinna of a subject with a neural stimulation device worn on the pinna of the subject, wherein the vibratory mechanical stimulus is of sufficient frequency and amplitude to modulate the activity of at least one mechanoreceptor with a receptive field on the at least a portion of the pinna. In addition to the foregoing, other method aspects are described in the claims, drawings, and text forming a part of the disclosure set forth herein.
In an aspect, a neural stimulation system includes, but is not limited to, a wearable neural stimulation device and a computing device (e.g., a personal computing device), the wearable neural stimulation device including a neural stimulator adapted to produce a stimulus for activating at least one sensory nerve fiber innervating at least a portion of a pinna of a subject, a securing member configured to secure the neural stimulator to the pinna, control circuitry incorporated into the wearable neural stimulation device for controlling operation of the neural stimulator, and first communication circuitry incorporated into the wearable neural stimulation device and operatively connected to the control circuitry, the first communication circuitry configured for at least one of sending a signal to and receiving a signal from a computing device; and the computing device including a user interface for at least one of presenting information to and receiving information from a user, control circuitry operatively connected to the user interface, second communication circuitry configured for at least one of sending a signal to and receiving a signal from the first communication circuitry, and instructions that when executed on the computing device cause the computing device to perform at least one of sending a signal to and receiving a signal from the wearable neural stimulation device via the second communication circuitry. In addition to the foregoing, other system aspects are described in the claims, drawings, and text forming a part of the disclosure set forth herein.
In an aspect, a system includes, but is not limited to, a computing device comprising circuitry for receiving a neural activity signal, the neural activity signal indicative of a physiological status of a subject, circuitry for determining a neural stimulus control signal based at least in part on the neural activity signal, and circuitry for outputting the neural stimulus control signal to a neural stimulation device including an external neural stimulator configured to be carried on a pinna of the subject, wherein the neural stimulus control signal is configured to control delivery of a neural stimulus by the external neural stimulator, the neural stimulus configured to activate at least one sensory nerve fiber innervating at least a portion of the pinna. In addition to the foregoing, other system aspects are described in the claims, drawings, and text forming a part of the disclosure set forth herein.
In an aspect, a method includes, but is not limited to, receiving a neural activity signal at a computing device, the neural activity signal indicative of a physiological status of a subject, determining a neural stimulus control signal based at least in part on the neural activity signal, and outputting the neural stimulus control signal from the computing device to a neural stimulation device including an external neural stimulator configured to be carried on a pinna of the subject, wherein the neural stimulus control signal is configured to control delivery of a neural stimulus by the external neural stimulator, the neural stimulus configured to activate at least one sensory nerve fiber innervating at least a portion of the pinna. In addition to the foregoing, other method aspects are described in the claims, drawings, and text forming a part of the disclosure set forth herein.
In an aspect, a computer program product includes, but is not limited to, a non-transitory signal-bearing medium bearing one or more instructions for receiving a neural activity signal, the neural activity signal indicative of a physiological status of a subject, one or more instructions for determining a neural stimulus control signal based at least in part on the neural activity signal, and one or more instructions for outputting the neural stimulus control signal to a neural stimulation device including an external neural stimulator configured to be carried on a pinna of the subject, wherein the neural stimulus control signal is configured to control delivery of a neural stimulus by the external neural stimulator, the neural stimulus configured to activate at least one sensory nerve fiber innervating at least a portion of the pinna. In addition to the foregoing, other aspects of a computer program product are described in the claims, drawings, and text forming a part of the disclosure set forth herein.
In an aspect, a method includes, but is not limited to receiving a physiological activity signal at a computing device, the physiological activity signal indicative of a physiological status of a subject, determining a neural stimulus control signal based at least in part on the physiological activity signal, outputting the neural stimulus control signal from the computing device to a neural stimulation device including an external neural stimulator configured to be carried on a pinna of the subject, wherein the neural stimulus control signal is configured to control delivery of a neural stimulus by the external neural stimulator, the neural stimulus configured to activate at least one sensory nerve fiber innervating at least a portion of the pinna, and presenting information to the subject via a user interface. In addition to the foregoing, other method aspects are described in the claims, drawings, and text forming a part of the disclosure set forth herein.
In an aspect, a system includes, but is not limited to a computing device including circuitry for receiving a physiological activity signal at a computing device, the physiological activity signal indicative of a physiological status of a subject, circuitry for determining a neural stimulus control signal based at least in part on the physiological activity signal, the neural stimulus control signal is configured to control delivery of a neural stimulus by the external neural stimulator, the neural stimulus configured to activate at least one sensory nerve fiber innervating at least a portion of the pinna, circuitry for outputting the neural stimulus control signal from the computing device to a neural stimulation device including an external neural stimulator configured to be carried on a pinna of the subject, and circuitry for presenting information to the subject via a user interface. In addition to the foregoing, other computing device aspects are described in the claims, drawings, and text forming a part of the disclosure set forth herein.
In an aspect, a computer program product includes, but is not limited to, a non-transitory signal-bearing medium bearing one or more instructions for receiving a physiological activity signal, the physiological activity signal indicative of a physiological status of a subject, one or more instructions for determining a neural stimulus control signal based at least in part on the physiological activity signal, one or more instructions for outputting the neural stimulus control signal to a neural stimulation device including an external neural stimulator configured to be carried on an ear of a subject, wherein the neural stimulus control signal is configured to control delivery of a neural stimulus by the external neural stimulator, the neural stimulus configured to activate at least one sensory nerve fiber innervating at least a portion of the pinna, and one or more instructions for presenting information to the subject via a user interface. In addition to the foregoing, other computer program product aspects are described in the claims, drawings, and text forming a part of the disclosure set forth herein.
In an aspect, a system includes, but is not limited to a computing device including circuitry for receiving a physiological activity signal at a computing device, the physiological activity signal indicative of a physiological status of a subject, circuitry for determining a neural stimulus control signal based at least in part on the physiological activity signal, circuitry for outputting the neural stimulus control signal from the computing device to a neural stimulation device including an external neural stimulator configured to be carried on a pinna of the subject, wherein the neural stimulus control signal is configured to control delivery of a neural stimulus by the external neural stimulator, the neural stimulus configured to activate at least one sensory nerve fiber innervating at least a portion of the pinna, and circuitry for outputting an audio output signal via an audio output of the computing device. In addition to the foregoing, other system aspects are described in the claims, drawings, and text forming a part of the disclosure set forth herein.
In an aspect, a method includes, but is not limited to, receiving a physiological activity signal at a computing device, the physiological activity signal indicative of a physiological status of a subject, determining a neural stimulus control signal based at least in part on the physiological activity signal, outputting the neural stimulus control signal from the computing device to a neural stimulation device including an external neural stimulator configured to be carried on a pinna of the subject, wherein the neural stimulus control signal is configured to control delivery of a neural stimulus by the external neural stimulator, the neural stimulus configured to activate at least one sensory nerve fiber innervating at least a portion of the pinna, and outputting an audio output signal via an audio output of the computing device. In addition to the foregoing, other method aspects are described in the claims, drawings, and text forming a part of the disclosure set forth herein.
In an aspect, a computer program product includes, but is not limited to, a non-transitory signal-bearing medium bearing one or more instructions for receiving a physiological activity signal at a computing device, the physiological activity signal indicative of a physiological status of a subject, one or more instructions for determining a neural stimulus control signal based at least in part on the physiological activity signal, one or more instructions for outputting the neural stimulus control signal from the computing device to a neural stimulation device including an external neural stimulator configured to be carried on a pinna of the subject, wherein the neural stimulus control signal is configured to control delivery of a neural stimulus by the external neural stimulator, the neural stimulus configured to activate at least one sensory nerve fiber innervating at least a portion of the pinna, and one or more instructions for outputting an audio output signal via an audio output of the computing device. In addition to the foregoing, other computer program product aspects are described in the claims, drawings, and text forming a part of the disclosure set forth herein.
In an aspect, a method includes, but is not limited to, determining a vibratory stimulus control signal with stimulation control circuitry in a computing device, and outputting the vibratory stimulus control signal from the computing device to a wearable mechanical stimulation device including a vibratory mechanical stimulator configured to be carried on a pinna of a subject, wherein the vibratory stimulus control signal is configured to control delivery of a vibratory stimulus by the vibratory mechanical stimulator, the vibratory stimulus configured to activate at least one mechanoreceptor with a receptive field on at least a portion of the pinna. In addition to the foregoing, other method aspects are described in the claims, drawings, and text forming a part of the disclosure set forth herein.
In an aspect, a system includes, but is not limited to, a computing device including circuitry for determining a vibratory stimulus control signal, and circuitry for outputting the vibratory stimulus control signal to a wearable mechanical stimulation device including a vibratory mechanical stimulator configured to be carried on a pinna of a subject, wherein the vibratory stimulus control signal is configured to control delivery of a vibratory stimulus by the vibratory mechanical stimulator, the vibratory stimulus configured to activate at least one mechanoreceptor with a receptive field on at least a portion of the pinna. In addition to the foregoing, other system aspects are described in the claims, drawings, and text forming a part of the disclosure set forth herein.
In an aspect, a computer program product includes, but is not limited to, a non-transitory signal-bearing medium bearing one or more instructions for determining a vibratory stimulus control signal configured to control delivery of a vibratory stimulus by a vibratory mechanical stimulator, the vibratory stimulus configured to activate at least one mechanoreceptor with a receptive field on at least a portion of a pinna of a subject, and one or more instructions for outputting the vibratory stimulus control signal to a wearable mechanical stimulation device including the least one vibratory mechanical stimulator. In addition to the foregoing, other computer program product aspects are described in the claims, drawings, and text forming a part of the disclosure set forth herein.
In an aspect, a method includes, but is not limited to, receiving identifying information at a computing system, the identifying information identifying at least one of a subject and a neural stimulation device associated with the subject, the neural stimulation device configured to be carried on an ear of a subject and including an external neural stimulator, and transmitting a recommendation relating to a treatment regimen from the computing system to a computing device used by the subject, the treatment regimen including delivery of a neural stimulus to the subject with the external neural stimulator, the neural stimulus configured to activate at least one sensory nerve fiber innervating skin on or in the vicinity of the ear of the subject. In addition to the foregoing, other method aspects are described in the claims, drawings, and text forming a part of the disclosure set forth herein.
In an aspect, a system includes, but is not limited to, circuitry for receiving identifying information identifying at least one of a subject and a neural stimulation device associated with the subject, the neural stimulation device configured to be carried on an ear of a subject and including an external neural stimulator, and circuitry for providing a recommendation relating to a treatment regimen to the subject, the treatment regimen including delivery of a neural stimulus to the subject with the external neural stimulator, the neural stimulus configured to activate at least one sensory nerve fiber innervating skin on or in the vicinity of the ear of the subject. In addition to the foregoing, other system aspects are described in the claims, drawings, and text forming a part of the disclosure set forth herein.
In an aspect, a computer program product includes, but is not limited to, a non-transitory signal-bearing medium bearing one or more instructions for receiving identifying information identifying at least one of a subject and a neural stimulation device associated with the subject, the neural stimulation device configured to be carried on an ear of a subject and including an external neural stimulator, and one or more instructions for providing a recommendation relating to a treatment regimen to the subject, the treatment regimen including delivery of a neural stimulus to the subject with the external neural stimulator, the neural stimulus configured to activate at least one sensory nerve fiber innervating skin on or in the vicinity of the ear of the subject. In addition to the foregoing, other computer program product aspects are described in the claims, drawings, and text forming a part of the disclosure set forth herein.
In an aspect, a nerve stimulation earpiece includes an ear canal insert, and a concha insert. The ear canal insert is adapted to fit into an ear canal of a human subject. The ear canal insert includes at least one first electrode configured to electrically contact skin within the ear canal of the subject. The concha insert is adapted to fit within a concha of the subject. The concha insert includes a base portion configured to fit within a cavum of the concha of the subject, a wing portion configured to fit within a cymba of the concha of the subject, and at least one second electrode configured to electrically contact at least a portion of the concha of the subject. The nerve stimulation earpiece further includes at least one first electrical connector for connecting the at least one first electrode on the ear canal insert to a first electrical current source, and at least one second electrical connector for connecting the at least one second electrode on the concha insert to a second electrical current source.
In an aspect, an ear stimulation device controller is disclosed. The ear stimulation device controller includes a first analog output connector adapted to connect a first current signal to a first electrode of an ear canal insert of an ear stimulation device, and a second analog output connector adapted to connect a second current signal to a second electrode of a concha insert of the ear stimulation device. The ear stimulation device controller further includes a wireless microcontroller configured to control wireless communication between the ear stimulation device controller and a computing device to receive one or more stimulation parameters from the computing device; a digital stimulus signal generator configured to generate a digital stimulus signal based at least in part on the one or more stimulation parameters received from the computing device; a digital-to-analog converter for converting the digital stimulus signal to an analog voltage waveform; a current driver operably connected to the digital-to-analog converter and adapted generate a controlled current stimulus waveform responsive to the analog voltage waveform; and a power source operably connected to at least one of the wireless microcontroller, the digital stimulus signal generator, the digital-to-analog converter, and the current driver. The controlled current stimulus waveform is provided to the ear stimulation device via at least the first analog output connector and the second analog output connector.
In an aspect, a nerve stimulation system includes a nerve stimulation earpiece and an ear stimulation device controller operably coupled to the nerve stimulation earpiece. A nerve stimulation earpiece includes an ear canal insert, and a concha insert. The ear canal insert is adapted to fit into an ear canal of a human subject. The ear canal insert includes at least one first electrode configured to electrically contact skin within the ear canal of the subject. The concha insert is adapted to fit within a concha of the subject. The concha insert includes a base portion configured to fit within a cavum of the concha of the subject, a wing portion configured to fit within a cymba of the concha of the subject, and at least one second electrode configured to electrically contact at least a portion of the concha of the subject. The nerve stimulation earpiece further includes at least one first electrical connector for connecting the at least one first electrode on the ear canal insert to a first electrical current source, and at least one second electrical connector for connecting the at least one second electrode on the concha insert to a second electrical current source. The ear stimulation device controller includes a first analog output connector adapted to connect a first current signal to a first electrode of an ear canal insert of an ear stimulation device, and a second analog output connector adapted to connect a second current signal to a second electrode of a concha insert of the ear stimulation device. The ear stimulation device controller further includes a wireless microcontroller configured to control wireless communication between the ear stimulation device controller and a computing device to receive one or more stimulation parameters from the computing device; a digital stimulus signal generator configured to generate a digital stimulus signal based at least in part on the one or more stimulation parameters received from the computing device; a digital-to-analog converter for converting the digital stimulus signal to an analog voltage waveform; a current driver operably connected to the digital-to-analog converter and adapted generate a controlled current stimulus waveform responsive to the analog voltage waveform; and a power source operably connected to at least one of the wireless microcontroller, the digital stimulus signal generator, the digital-to-analog converter, and the current driver. The controlled current stimulus waveform is provided to the ear stimulation device via at least the first analog output connector and the second analog output connector.
In an aspect, a method of controlling an ear stimulation device with a computing device includes, but is not limited to, capturing, with image capture circuitry on the computing device, via a user-facing imager (e.g. a camera or scanner) associated with the computing device, an image of a user of the computing device; processing the image, using image processing circuitry on the computing device, to determine at least one parameter; and controlling, with neural stimulus control signal determination circuitry on the computing device, based at least in part on the at least one parameter, delivery of a stimulus to at least one nerve innervating an ear of the user with the ear stimulation device. In a further aspect, the method includes processing the image, using the image processing circuitry, to determine the presence of at least one earpiece of the ear stimulation device located at an ear of the user; the ear of the user at which the at least one earpiece is located, the ear selected from a right ear of the user and a left ear of the user; and at least one attribute of the at least one earpiece indicative of usability of the at least one earpiece with one of the left or the right ear of the user; determining, using application software on the computing device, the ear at which the earpiece is usable, based on the at least one attribute of the at least one earpiece; determining, using application software on the computing device, whether the ear at which the at least one earpiece is located is the ear at which the earpiece is usable; and if the ear at which the at least one earpiece is located is not the ear at which the earpiece is usable, sending a control signal from the computing device to the ear stimulation device, under control of the neural stimulus control signal determination circuitry, to prevent delivery of a stimulus to the ear at which the earpiece is located via the earpiece. In addition to the foregoing, other method aspects are described in the claims, drawings, and text forming a part of the disclosure set forth herein.
In an aspect, an ear stimulation device control system includes, but is not limited to, a computing device; a user-facing imager associated with the computing device; image capture circuitry adapted to capture an image of a user of the computing device from the user-facing imager; image processing circuitry configured to process the image to determine at least one parameter; and neural stimulus control signal determination circuitry configured to control delivery of a stimulus to at least one nerve innervating an ear of the user with an ear stimulation device, based at least in part on the at least one parameter. In a further aspect, image processing circuitry includes an earpiece location module configured to process the image to determine the presence of at least one earpiece of the ear stimulation device located at an ear of the user; the ear of the user at which the at least one earpiece is located, the ear selected from a right ear of the user and a left ear of the user; and at least one attribute of the at least one earpiece indicative of usability of the at least one earpiece with one of the left or the right ear of the user; and the neural stimulus control signal determination circuitry is configured to determine the ear at which the earpiece is usable, based on the at least one attribute of the at least one earpiece;
determine whether the ear at which the at least one earpiece is located is the ear at which the earpiece is usable; and if the ear at which the at least one earpiece is located is not the ear at which the earpiece is usable, send a control signal from the computing device to the ear stimulation device to prevent delivery of the stimulus to the a least one nerve innervating the ear of the user. In addition to the foregoing, other system aspects are described in the claims, drawings, and text forming a part of the disclosure set forth herein.
In an aspect, a method of controlling an ear stimulation device with a computing device includes, but is not limited, to detecting at electrical signal input circuitry, via at least one first electrode of an earpiece of an ear stimulation device, an electrical signal indicative of electrical contact of the at least one first electrode with the ear of a user of a computing device, wherein the at least one earpiece is operably connected to the computing device, and wherein the ear stimulation device is adapted to stimulate at least one nerve innervating the ear of the user of the computing device; determining, using contact determination circuitry on the computing device, whether the at least one first electrode is in good electrical contact with the ear of the user; if the at least one first electrode is not in good electrical contact with the ear of the user, sending a control signal from the computing device to the ear stimulation device, under control of neural stimulus control signal determination circuitry on the computing device, to prevent delivery via the earpiece of a stimulus to the ear at which the earpiece is located; and delivering, under control of notification circuitry on the computing device, a notification to the user relating to the status of the at least one first electrode. In addition to the foregoing, other method aspects are described in the claims, drawings, and text forming a part of the disclosure set forth herein.
In an aspect, an ear stimulation device control system includes, but is not limited to, a computing device configured to control delivery via an ear stimulation device of a stimulus to at least one nerve innervating an ear of a user of the computing device, the ear stimulation device including at least one first electrode, and the computing device including electrical signal circuitry adapted to receive an electrical signal indicative of electrical contact of the at least one first electrode with the ear of a user of the computing device; contact determination circuitry configured to determine whether the at least one first electrode is in good electrical contact with the ear of the user; neural stimulus control signal determination circuitry configured to send a control signal from the computing device to the ear stimulation device to prevent delivery of the stimulus if the at least one first electrode is not in good electrical contact with the ear of the user; and notification circuitry configured to deliver a notification to the user relating to the status of the at least one first electrode. In addition to the foregoing, other system aspects are described in the claims, drawings, and text forming a part of the disclosure set forth herein.
In an aspect, a computing device application for monitoring use of a nerve stimulation system by a user includes, but is not limited to, an audio delivery module adapted to control delivery of an audio signal from an audio signal source to an audio earpiece via an audio output of the computing device, the audio earpiece having associated therewith an ear stimulation device configured to stimulate a nerve innervating the ear of the user; a mood assessment module adapted to receive mood-related input from the user via a first input structure associated with the computing device; and assess a mood of the user based at least in part upon the mood-related input; a secondary factor input module adapted to receive at least one input relating to at least one secondary factor relating to the user via a second input structure associated with the computing device; user control module adapted to receive at least one user control input via a third input structure of the computing device, the user control input for controlling user-controllable stimulation parameters of the ear stimulation device; a stimulator control module adapted to determine at least one stimulus control parameter based on at least one of the mood of the user, the at least one secondary factor, and the at least one user control input; and a controller interface module for communicating the at least one stimulus control parameter to a stimulator controller adapted to control the ear stimulation device responsive to the at least one stimulus control parameter. In addition to the foregoing, other system aspects are described in the claims, drawings, and text forming a part of the disclosure set forth herein.
In an aspect, a method of controlling an ear stimulation device with a computing device includes, but is not limited to, receiving an audio signal at the computing device from an audio signal source; delivering the audio signal to an audio earpiece worn by a user via an audio output of the computing device, the audio earpiece having associated therewith an ear stimulation device configured to stimulate a nerve innervating the ear of the user; receiving with a mood assessment module, via a first input structure associated with the computing device, a mood-related input from the user; assessing, with the mood assessment module, a mood of the user based at least in part upon the mood-related input; receiving with a secondary factor input module, via a second input structure associated with the computing device, at least one input relating to at least one secondary factor relating to the user; receiving with a user control module, via a third input structure associated with the computing device, at least one user control input for controlling at least one user-controllable stimulation parameter of the ear stimulation device; determining, with a stimulator control module, at least one stimulus control parameter based on at least one of the mood of the user, the at least one secondary factor, and the at least one user control input; and communicating, with a controller interface module, at least one stimulus control parameter to a stimulator controller, the stimulator controller adapted to control the ear stimulation device responsive to the at least one stimulus control parameter. In addition to the foregoing, other method aspects are described in the claims, drawings, and text forming a part of the disclosure set forth herein.
Features from any of the disclosed embodiments can be used in combination with one another, without limitation. In addition, other features and advantages of the present disclosure will become apparent to those of ordinary skill in the art through consideration of the following detailed description and the accompanying drawings.
The foregoing summary is illustrative only and is not intended to be in any way limiting. In addition to the illustrative aspects, embodiments, and features described above, further aspects, embodiments, and features will become apparent by reference to the drawings and the following detailed description.
In the following detailed description, reference is made to the accompanying drawings, which form a part hereof. In the drawings, similar symbols typically identify similar components, unless context dictates otherwise. The illustrative embodiments described in the detailed description, drawings, and claims are not meant to be limiting. Other embodiments may be utilized, and other changes may be made, without departing from the spirit or scope of the subject matter presented here.
Various studies indicate that stimulation of the ear can have beneficial effects on the health of a subject. For example, Rong et al., “Transcutaneous vagus nerve stimulation for the treatment of depression: a study protocol for a double blinded randomized clinical trial,” BMC Complementary and Alternative Medicine 2012, 12:255, which is incorporated herein by reference, describes the possibility of using transcutaneous stimulation of the vagus nerve via portions of the ear to treat major depressive disorder (MDD) and other disorders, including epilepsy, bipolar disorder, and morbid obesity. Ellrich, “Transcutaneous Vagus Nerve Stimulations,” European Neurological Review, 2011; 6(4):254-256, which is incorporated herein by reference, describes transcutaneous vagus nerve stimulation via the ear for treating epilepsy and depression.
Nerves innervating the skin on or in the vicinity of the ear of the subject include, e.g., the facial nerve (cranial nerve VII), a nerve located in the neck, the glossopharyngeal nerve (cranial nerve IX), the auricular branch of the vagus nerve (cranial nerve X), the auriculotemporal branch of trigeminal nerve (cranial nerve V), the lesser occipital nerve (spinal nerve C3), and the greater auricular nerve (spinal nerves C2, C3). These nerves contain various nerve fibers including sensory nerve fibers, including, for example, nerve fibers from skin mechanoreceptors. Various types of skin mechanoreceptors are well characterized and are innervated by fibers having diameters in the range of approximately 5 to 12 μm (also known as Aβ fibers). Skin mechanoreceptors include, for example, slowly adapting mechanoreceptors, which are more sensitive to continuous stimulation, and rapidly adapting mechanoreceptors, which are more sensitive to transient stimuli. Rapidly adapting mechanoreceptors include Pacinian corpuscles and Meissner's corpuscles, for example.
Mechanoreceptors are activated well by cyclical or vibratory (e.g., sinusoidal) mechanical stimuli having frequencies in the range of 1 Hz to 1000 Hz. In some aspects, such mechanical stimuli may include indentation of the skin by a few micrometers to a few millimeters. Pacinian corpuscles are thought to be most responsive to vibratory mechanical stimuli with frequencies in the range of 200 Hz-300 Hz, while Meissner's Corpuscles are thought to be most responsive to vibratory mechanical stimuli with frequencies in the range of 30-40 Hz.
Electrical stimuli having sinusoidal or other waveforms are also effective for activating sensory fibers. Stimuli may be applied cyclically, for example. See e.g., Ellrich, “Transcutaneous Vagus Nerve Stimulations,” European Neurological Review, 2011; 6(4):254-256, which is incorporated herein by reference.
In some embodiments, the stimulation of the ear can be used to treat, prevent, or otherwise address mood disorders. Examples of mood disorders that can be treated by stimulation of the ear include stress, depression, and anxiety. In some embodiments, the stimulation of the can be used to treat headaches.
In some embodiments, the stimulation of the ear can be used to treat, prevent, or otherwise address a sleeping disorder instead of or in conjunction with other disorders (e.g., MDD, epilepsy, etc.). A sleeping disorder can include a sleep-related respiratory disorder (e.g., sleep apnea, hypopnea, hyperpnea, snoring, or hyperventilation), a parasomnia (e.g., bruxism, periodic limb movement disorder, restless leg syndrome, sleep paralysis, sleep terrors, somniloquy, or somnambulism), a hypersomnolence disorder (e.g., narcolepsy, hypersomnia, etc.), or an insomnia disorder. The sleep disorder can be caused by, be affected by, or be secondary to a clinical condition, for example, a metabolic disorder, a cardiac disorder, a neural disorder (e.g., Alzheimer's Disease or Parkinson's Disease), a traumatic injury (e.g., a traumatic brain injury), or a mental health disorder (e.g., PTSD, anxiety, etc.)
The sleep disorder can include sleep apnea or snoring. For example, the devices disclosed herein can include sensors that are configured to detect one or more characteristics of a sleeping disorder, such as audio sensors that detect snoring or lack of breathing. Responsive to detecting the one or more characteristics of the sleeping disorders, the devices disclosed herein can provide a stimulus to the individual. In an embodiment, the stimulus can be configured to wake the individual. In another embodiment, the stimulus can trigger a subconscious response that causes an individual to perform an action (e.g., resume breathing or to roll over). In such an embodiment, the subconscious response can be learned by repetitiously performing the action responsive to the stimulus while the person is awake. The stimulus provided by the device can include any of the stimuluses disclosed herein, such as a vibratory stimulus, an electrical stimulus targeting the vagus nerve or another nerve, an audio signal (e.g., beep), etc.
For reference,
In the embodiment of
In an aspect, neural stimulator 212 is a mechanical stimulator. In an aspect, a mechanical stimulator includes, for example, a vibratory mechanical stimulator that delivers a cyclical or vibrating mechanical stimulus to the skin of the ear of the subject 206. Vibratory mechanical stimulators can include, for example, various types of vibrating mechanical devices, e.g., electromechanical, piezoelectric, movable coil, electrostatic, magnetostrictive, isodynamic, and/or MEMS devices, for example as used for manufacturing small-scale speakers and microphones.
In an aspect, neural stimulator 212 includes a transcutaneous electrical stimulator for delivering a transcutaneous electrical stimulus. For example, neural stimulator 212 may include at least one electrode pair or electrical contact designed for contacting the skin surface, for example as described in Rong et al., “Transcutaneous vagus nerve stimulation for the treatment of depression: a study protocol for a double blinded randomized clinical trial,” BMC Complementary and Alternative Medicine 2012, 12:255, which is incorporated herein by reference.
The neural stimulator 212 can include a cathode or an anode. In an embodiment, the cathode of the neural stimulator 212 can be configured to be positioned to contact the concha of the pinna (e.g., the cymba 122 and/or cavum 124 of the concha 120 of
In an embodiment, each of the neural stimulator 212 and the optional additional neural stimulator 222 includes an electrode pair. The electrode pairs of the neural stimulator 212 and the optional additional neural stimulator 222 can include a cathode and an anode. Each electrode pair of the neural stimulator 212 and the optional additional neural stimulator 222 is configured to apply an electric field and/or flow an electrical current through different portions of the ear 204. For example, the electrode pair of the neural stimulator 212 can be configured to contact the cymba of the pinna and a corresponding portion of the posterior surface of the pinna such that an electric field is applied and/or an electrical current flows through the cymba. Additionally, the electrode pair of the optional additional neural stimulator 222 can be configured to contact the cavum of the pinna and a corresponding portion of the posterior surface of the pinna such that an electric field is applied and/or an electrical current flows through the cymba. Configuring the electrode pairs of the neural stimulator 212 and the optional additional neural stimulator 222 to contact the cymba and cavum of the pinna, respectively, permits both electrode pairs to stimulate the vagus nerve. As such, having both electrode pairs increases the likelihood that the vagus nerve is stimulated (e.g., if one pair of electrodes is improperly positioned or does not form a good contact with the ear), allows the vagus nerve to be stimulated differently than if only one of the electrode pairs is used, allows stimulation of different portions of the vagus nerve, can provide different effects on the vagus nerve than if only one of the electrode pairs is used, or, as will be discussed in more detail below, can decrease the likelihood of nerve accommodation in the vagus nerve. In some embodiments, stimuli can be delivered simultaneously through two or more electrode pairs, and the relative intensities and/or polarities of stimuli delivered via the two or more electrodes pairs can be adjusted to steer the electrical field maxima and minima within the tissue to adjust the position of the electrical field relative to the two electrode pairs. In some embodiments, two cathodes can be used in combination with a single anode, or two cathodes with a single anode (e.g. in a tripolar configuration).
In an embodiment, at least one of the electrode pairs of the neural stimulator 212 and the optional additional neural stimulator 222 can be configured to contact a region of the pinna that is distinct from the cymba and/or the cavum. In such an embodiment, at least one of the neural stimulator 212 and the optional additional neural stimulator 222 includes an electrode pair that can stimulate a nerve other than the vagus nerve, stimulate a different portion of the vagus nerve, etc. For example, the electrode pair of the neural stimulator 212 and/or the optional additional neural stimulator 222 can at least one of be spaced from the concha, contact the triangular fossa, contact the superior crus of antihelix, contact the helix, contact the antihelix, contact the inferior crus of antihelix, contact the antitragus, contact the lobe, contact another portion of the pinna, stimulate the facial nerve, stimulate the trigeminal nerve, stimulate the glossopharyngeal nerve, or stimulate another nerve. In an embodiment, the wearable neural stimulation device 202 can include one or more additional neural stimulators that are distinct from the neural stimulator 212 and the optional additional neural stimulator 222.
In an aspect, neural stimulator 212 includes a magnetic stimulator for delivering a transcutaneous magnetic stimulus. For example, such a magnetic stimulator may include one or more coil through which electrical current is passed to generate a magnetic field. The magnetic field induces electrical currents within the tissue in/around the ear 204 of the subject 206 to activate neural structures.
In an aspect, neural stimulator 212 includes an ultrasonic stimulator, for example as described in Legon et al., “Pulsed Ultrasound Differentially Stimulates Somatosensory Circuits in Humans as Indicated by EEG and fMRI,” PLOS ONE 7(12): e5177. Doi:10.01371/journal.pone.0051177, December 2012, which is incorporated herein by reference.
In some aspects, the neural stimulator 212 can include other types of neural stimulators, such as optical, thermal, or chemical stimulators. See, for example, stimulators described in U.S. Pat. No. 8,170,658 to Dacey, Jr. et al., which is incorporated herein by reference.
In an embodiment, the neural stimulator 212 can include an array. In such an embodiment, the neural stimulator 212 can include a plurality of electrodes, ultrasonic emitters, vibrators, or other devices that are positioned adjacent or proximate to each other. The array can improve focusing of the stimulus compared to a neural stimulator that only includes a single device that can emit the stimulus. The array also allows the neural stimulator 212 to provide the stimulus to a larger area of the ear or multiple sites on the ear, which increases the likelihood that the stimulus interacts with a selected nerve.
In an embodiment, the at least one neural stimulator 212 and, optionally, the neural stimulator 222, can be configured to contact one or more locations on the ear. For example, the at least one neural stimulators 212, 222 can individually or collectively be configured to contact one, two, three, four, five, six, seven, eight, nine, or at least ten different locations of the pinna. The number of locations that the neural stimulators 212, 222 contact and the particular locations that are contacted by the neural stimulators 212, 222 can depend on the type of stimulation provided by the neural stimulators 212, 222 (e.g., electrical stimulus, magnetic stimulus, etc.) and the disorder that the wearable neural stimulation device 202 is configured to treat.
The stimulus provided by the neural stimulator 212 (e.g., the transcutaneous electrical stimulus or any other stimulus disclosed herein) can exhibit a variety of parameters (e.g., voltage, electrical current, frequency, pulse duration, etc.). In an embodiment, the neural stimulator 212 is configured to provide a stimulus exhibiting a voltage (e.g., a constant or variable voltage) of at least about 1.25 volts (V), such as in ranges of about 1.25 V to about 10 V, about 2.5 V to about 5 V, about 2 V to about 4 V, about 2.5 V to about 3.5 V, about 3 V to about 4 V, about 3.5 V to about 4.5 V, about 4 V to about 5 V, or about 4.5 V to about 7.5 V. In an example, the neural stimulator 212 is configured to provide a stimulus exhibiting an electrical current (e.g., a constant or variable electric current, current amplitude) of at least about 50 microampere (μA), such as in ranges of about 50 μA to about 10 milliampere (mA), about 100 μA to about 5 mA, about 500 μA to about 2 mA, about 100 μA to about 500 μA, about 250 μA to about 750 μA, about 500 μA to about 1 mA, about 750 μA to about 1.5 mA, about 1 mA to about 2 mA, about 1.5 mA to about 3 mA, or about 2.5 mA to about 5 mA. In such an example, the neural stimulator 212 can have sufficient control over the electrical current that, with the current (e.g., currently amplitude) held constant over a session treatment (e.g., a session treatment having a length of 40 minutes), the electrical current delivered into a known load of 20 kΩ between any pair of electrodes varies at most about 1%, at most about 5%, at most about 10%, or at most about 20%. Further, the neural stimulator 212 can have set points between any of the above currents with a resolution of less than or equal to about 10 μA, about 25 μA, about 40 μA, about 70 μA, about 100 μA, about 500 μA, or about 1 mA. In an embodiment, the neural stimulator 212 is configured to provide a stimulus exhibiting a pulse duration that is at least 20 microsecond (μs), such as in ranges of about 20 μs to about 2 millisecond (ms), about 50 μs to about 1 ms, about 100 μs to about 500 μs, about 50 μs to about 150 μs, about 100 μs to about 200 μs, about 150 μs to about 300 μs, about 250 μs to about 500 μs, about 400 μs to about 800 μs, or about 750 μs to about 1.5 ms. In an embodiment, the neural stimulator 212 is configured to provide a stimulus exhibiting, during normal operation, a maximum frequency of about 500 Hz, such as in ranges of about 1 Hz to about 100 Hz, about 50 Hz to about 150 Hz, about 100 Hz to about 200 Hz, about 150 Hz to about 250 Hz, about 200 Hz to about 300 Hz, about 250 Hz to about 350 Hz, about 300 Hz to about 400 Hz, about 350 Hz to about 450 Hz, or about 400 Hz to about 500 Hz. The neural stimulator 212 can be configured to provide a stimulus exhibiting, during bursts (e.g., a grouping of consecutive pulses), a frequency that is greater than about 500 Hz, such as in ranges of about 500 Hz to about 10 kHz, about 500 Hz to about 1 kHz, about 750 Hz to about 1.5 kHz, about 1 kHz to about 2 kHz, about 1.5 kHz to about 3 kHz, about 2.5 kHz to about 5 kHz, about 4 kHz to about 7 kHz, or about 6.5 kHz to about 10 kHz. The frequency of the stimulus can also be greater than 500 Hz depending on the type of stimulus (e.g., ultrasonic stimulus can exhibit a frequency that is significantly greater than 500 Hz). In such an example, the neural stimulator 212 can have sufficient control over the frequency that, with the frequency being held constant over a session treatment, the frequency of the stimulus varies by no more than about 10 μs, about 25 μs, about 40 μs, about 70 μs, or about 100 μs. Further, the neural stimulator 212 can have set points between any of the above frequencies with a resolution of about 1 Hz to about 1 kHz. During bursts, the stimulus provided by the neural stimulator 212 can exhibit a burst width of about 100 μs to about 1 second (s), such as in ranges of about 100 μm to about 1 ms, about 500 μs to about 5 ms, about 1 ms to about 10 ms, about 5 ms to about 50 ms, about 10 ms to about 100 ms, about 50 ms to about 500 ms, or about 100 ms to about 1 s. In such an example, the neural stimulator 212 can have sufficient control over the burst widths that, with the frequency being held constant over a session treatment, the burst width vary by no more than about 10 μs, about 50 μs, about 100 μs, about 250 μs, or about 500 μs. Further, the neural stimulator 212 can set points between any of the above burst widths with a resolution of less than or equal to about 1 μs, about 2 μs, about 5 μs, about 10 μs, about 50 μs, or about 100 μs. Other examples of stimulus parameters include magnetic field strength, stimulus intensity (e.g., amplitude), temperature, cycles, etc. In an example, the stimulus provided by the neural stimulator 212 can exhibit any of the stimulus parameters disclosed herein.
The neural stimulator 212 can be configured to apply bursts of the stimulus during a first period of time followed by second period of time during which the neural stimulator 212 does not provide the stimulus. For example, the first period of time can be greater than about 50 μs, such as in ranges of about 50 μs to about 500 μs, about 100 μs to about 1 ms, about 500 μs to about 5 ms, about 1 ms to about 10 ms, about 5 ms to about 50 ms, about 10 ms to about 100 ms, about 50 ms to about 500 ms, about 100 ms to about 1 second, about 500 ms to about 5 seconds, or greater than 1 second. In such an example, neural stimulator 212 can have set points between any of the above first periods of time with a resolution of less than or equal to about 10 μs, about 20 μs, about 50 μs, or about 100 μs. In an example, the first period of time and the second period of time, collectively, can be greater than about 1 ms, such as in ranges of about 1 ms to about 10 ms, about 5 ms to about 50 ms, about 10 ms to about 100 ms, about 50 ms to about 500 ms, about 100 ms to about 1 second, about 500 ms to about 5 seconds, about 1 second to about 10 seconds, about 5 seconds to about 1 minutes, or greater than 10 seconds. In such an example, the neural stimulator 212 can have set points between any of the above ranges with a resolution of less than or equal to 1 about 0 μs, about 20 μs, about 50 μs, or about 100 μs.
In an embodiment, the neural stimulator 212 is configured to provide a stimulus during one or more cycles (e.g., a predetermined grouping of bursts). The one or more cycles can include an on period (i.e., applying the stimulus to the ear 204) and an off period (i.e., ceasing to apply the stimulus to the ear 204) or can include providing different stimuli to the ear 204 in a particular (e.g., repetitious) stimulation pattern. In an example, the first period of time and the second period of time, collectively, can be greater than about 500 ms, such as in ranges of about 500 ms to about 2 seconds, about 1 ms to about 5 seconds, about 2 second to about 10 seconds, about 5 seconds to about 20 seconds, about 10 seconds to about 30 seconds, about 25 minutes to about 50 minutes, or greater than about 30 seconds. In such an example, the neural stimulator 212 can have set points for the collective first and second periods of time between any of the above ranges with a resolution of less than or equal to about 500 μs, about 1 ms, about 2 ms, about 5 ms, about 10 ms, about 20 ms, about 50 ms, or about 100 ms. The neural stimulator 212 can have sufficient control over the first and second time periods collectively that the collective first and second times periods vary, over a full treatment session, by no more than about 500 μs, about 1 ms, about 2 ms, about 5 ms, about 10 ms, or about 50 ms.
The stimulus parameters that the neural stimulator 212 is configured to apply to the ear 204 can vary depending on a number of factors. For example, the stimulus parameters can be selected based on the disorder that the wearable neural stimulation device 202 is configured to treat. In another embodiment, the stimulus parameters can be selected based on the subject 206. For example, the stimulus parameters can be selected based on the preferences of the subject 206, how difficult it is to awake the subject 206, the age of the subject 206 (e.g., older subjects can be stimulated with a stimulus exhibiting a higher voltage or current than younger subjects), etc. In an embodiment, the stimulus parameters can be selected to prevent or inhibit accommodation of a nerve (e.g., the vagus nerve or another nerve that can become habituated if the stimulus characteristics are not periodically varied).
The neural stimulator 212 can be configured to provide the stimulus to the ear 204 according to at least one stimulation pattern. The stimulation pattern refers to the stimulus parameters of the stimulus that is provided to the ear 204. In an embodiment, the stimulation pattern can include how the stimulus parameters vary over time or does not vary over time. In such an embodiment, the stimulation patterns can include cycling the stimulus parameters (e.g., periodically repeating the same stimulation patterns). In an embodiment, the stimulation patterns can include how long the stimulus is provided to the ear 204. In an embodiment, the stimulation pattern can include providing random pulses or burst of pulses of the stimulus to the ear 204.
Altered neuronal response to the stimulus, over time, can result due to various neurological phenomena, including accommodation, adaptation, habituation, etc. (collectively referred to here as “nerve accommodation”). Nerve accommodation entails a diminished neural response over time, for example following continuous stimulation. The nerve accommodation can include acute or immediate neuronal accommodation (e.g., nerve accommodation caused by a single instance of providing stimulus to the ear 204) or cumulative or residual neuronal accommodation (e.g., nerve accommodation caused by a plurality of instances of providing stimulus to the ear 204 over a prolonged period of time). As used herein, nerve accommodation generally refers to any decrease in neural responsiveness or sensitivity following the application of the stimulus, for example, during continuous stimulation.
Nerve accommodation is more likely to occur if the same stimulus is continuously provided to the nerve without varying the stimulation. As such, system 200 can include hardware and/or software modalities to overcome (i.e., reduce, minimize, or ameliorate) accommodation. In an embodiment, the system 200 includes multiple neural stimulators (e.g., neural stimulator 212 and neural stimulator 222) able to work separately or together to vary the direct input of the stimulus. For example, the system 200 may include multiple sets of electrodes, multiple ultrasound emitters (e.g., multiple ultrasound emitters arranged in an array), etc. In an embodiment, the system 200 includes software that is programmable, which allows an individual using the system 200 (e.g., the subject 206, a medical practitioner, etc.) to direct the stimulus in a manner that overcomes or minimizes nerve accommodation. For example, the programming from the individual can direct the system 200 to produce a specified pattern, pulse, burst, frequency, or timing (e.g., a stimulation period followed by a rest period) of the stimulation. In an embodiment, the system 200 includes hardware and software to overcome nerve accommodation by altering a characteristics of the stimulation, such as the duration, intensity, amplitude, or frequency of the stimulation. For example, the system 200 might use programming and one or more set of electrodes to vary the stimulation pattern by varying the frequency, the intensity, the pulse rate, or the pulse duration of the electrical stimulation. In addition, stimuli applied via different electrodes can be separately adjusted to control the relative intensity of stimulation applied via different electrodes, for example to produce steering.
In an embodiment, the system 200 and methods of using the system 200 can employ a cycle of stimulation to overcome nerve accommodation. In an embodiment, the cyclical stimulation can include a cycle of two or more stimulation patterns in a single treatment or over a series of treatments. In such an example, the system 200 can include two or more programs that each have different stimulation patterns, wherein each of the stimulation patterns includes a set of treatment variables (e.g., pulse rate, duration, intensity, frequency, etc.) used for stimulation. The system 200 may cycle through the two or more programs during a single treatment, for example, to overcome acute or immediate neural accommodation. Also or instead, the system 200 may cycle through the two or more programs during a series of treatments (e.g., using a different program during each treatment, using a different selection of the programs during each treatment, performing the programs in different orders during each treatment, etc.) to overcome any cumulative or residual neuronal accommodation.
In an embodiment, the different stimulation patterns of the two or more programs can change the stimulus provided by neural stimulator 212 by changing the type of stimulus, that is, changing from a first type of stimulus (e.g., one of mechanical, electrical, magnetic, ultrasound, optical, thermal, or chemical stimulus) to a second type of stimulus (e.g., another of mechanical, electrical, magnetic, ultrasound, optical, thermal, or chemical stimulus). In an embodiment, the different stimulation patterns of the two or more programs can change the stimulus provided by neural stimulator 212 by changing at least one stimulus parameter (e.g., time-varying stimulation pattern). In an embodiment, the different stimulation patterns of the two or more programs can change the stimulus provided by neural stimulator 212 by causing the neural stimulator to provide planned, ordered, and/or random pulses to the nerve (e.g., pulsed stimulation pattern). In an embodiment, the different stimulation patterns of the two or more programs can change the stimulus provided by neural stimulator 212 by causing the neural stimulator to provide bursts of the stimulus (e.g., increased frequency, intensity, etc.) to the nerve, such as providing random bursts to the nerve. In an example, the different stimulation patterns of the two or more programs can change the stimulus provided by neural stimulator 212 by providing a first stimulation pattern to the neural stimulator 212 and a second stimulation pattern to the optional additional neural stimulator 222 simultaneously. In such an example, the two different stimulation patterns can effect a nerve differently than if the nerve was stimulated by only one of the first stimulation pattern or the second stimulation pattern. Different stimulation patterns applied via neural stimulator 212 and neural stimulator 222 simultaneously can produce a steering effect, as described herein above.
In an embodiment, the system 200 can include means and methods to determine a potential or actual occurrence of nerve accommodation. In an example, the system 200 can include programing that calculates the time point following stimulation at which nerve accommodation would likely occur. In such an embodiment, the system 200 can adjust the stimulation to account for that nerve accommodation. In an embodiment, the system 200 can include means for detecting or measuring nerve accommodation directly or indirectly. For example, the sensor 220 of the system 200 can be configured to detect a bioelectric activity of a nerve, detect other physiological characteristics of the subject 206 affected by stimulation of the nerve, etc. The physiological characteristics of the subject 206 that are affected by stimulation of the vagus nerve can include, for example, cardiopulmonary parameters (e.g., heart rate, blood pressure, etc.).
The different stimulation patterns provided by the neural stimulator 212 to the ear 204 can have different effects on the subject 206. As such, the stimulation patterns can be selected to have selected effect(s) on the subject 206. The selected effect(s) that the stimulation patterns can have on the individual can include at least one of treating a disorder (e.g., treating different disorders), preventing or inhibiting nerve accommodation, or causing a selected response in the subject 206. In an embodiment, the selected effect(s) that the stimulation patterns have on the subject 206 can be selected based on the subject 206 and/or the disorder that is being treated. For example, a subject that is prone to nerve accommodation may be subjected to a variable stimulus more than a subject who is not as prone to nerve accommodation. In another example, a subject that is being treated for MDD can receive a different stimulation pattern (e.g., stronger or longer stimulation pattern) than a subject who is being treated for a sleeping disorder.
The effects that the stimulation patterns provided by the neural stimulator 212 to the ear 204 can vary depending on which part of the ear 204 is stimulated, which ear is stimulated, and/or if one or both ears are stimulated. For example, providing the stimulus to the left ear can treat at least some types of epilepsy and/or depression, while the same stimulus provided to the right ear can have little to no effect on the same types of epilepsy and/or depression but may have value in treating other disorders.
In an aspect, circuitry for driving delivery of the neural stimulus is included fully or partially in wearable neural stimulation device 202. In an aspect, some or all of the circuitry for driving delivery of the neural stimulus are housed separately from wearable neural stimulation device 202 (e.g., in the computing device 208 and/or the remote system 216), and a control signal for driving delivery of the neural stimulus by neural stimulator 212 is provided by computing device 208, or from remote system 216 via communication network 218 (e.g., thereby enabling telemedicine). In either aspect, the circuitry for driving delivery of the neural stimulus can include memory storing instructions and a processor that executes the instructions stored on the memory. The instruction stored on the memory can include at least one stimulation pattern stored thereon, such as any of the stimulation patterns disclosed herein. As such, executing instructions with the processor can cause the circuitry to direct the neural stimulator 212 to provide the stimulus in at least one stimulation pattern.
In an embodiment, as shown in
In an embodiment, at least one of the control circuitry 224, the computing device 208, or the remote system 216 can include a shutdown feature that is configured to cease application of the stimulus, partially shut down the system 200, completely shut down the system 200, or refuse to initiate treatment. The shutdown feature can be triggered responsive to one or more characteristics sensed by the sensor 220 or another sensor that indicate a fault (e.g., a malfunction, defective component, unsafe operating condition, etc.). In an example, the shutdown feature can be triggered responsive to detecting a high temperature in the wearable neural stimulation device 202 or detecting a high current from the neural stimulator 212. The shutdown feature can remain active until the fault is remedied.
In an embodiment, the wearable neural stimulation device 202 is configured to perform a self-test to detect any faults. For example, the sensor 220 or another sensor can detect one or more characteristics of the wearable neural stimulation device 202 that may indicate a fault. The wearable neural stimulation device 202 can perform the self-test and, if the self-test detects a fault, the wearable neural stimulation device 202 can activate the shutdown feature thereof. The wearable neural stimulation device 202 can perform the self-test at least one of before treatment commences, during the treatment, or after the treatment ends. In an example, the self-test can include detecting a fault if the voltage at the low end of a power supply range is not within a preselected percentage (e.g.,±5%) of a nominal range. It is noted that, in some examples, the high end of the power supply range is not tested in order to avoid creating a large energy buildup that needs to be dissipated. In an example, the self-test can include detecting a fault if the current sense reference voltage measurement is not within a nominal range (e.g., 0.8 V±5%). In an example, the self-test can include detecting a fault if the voltage monitored on each electrode is not within a selected amount (e.g.,±0.2 V) of the power supply voltage for the maximum and minimum supply voltages. In an example, the self-test can include detecting a fault if the operation of a clock oscillator if the ratio between the two clocks' measurements is not within a selected percentage (e.g., within 1%) of an expected value. In an example, the self-test can include detecting a fault if there is not sufficient battery charge remaining to complete the requested treatment session. In an example, the self-test can include detecting a fault by determining if an open-circuity electrode condition or short-circuity electrode condition arises during treatment. In an example, the self-test can include detecting a fault if the output current exceeds any preselected value (e.g., about 10 mA, about 20 mA, or about 50 mA) and/or if the output voltages exceeds any preselected value (e.g., about 10 V, about 20 V, about 40V, or about 60V) for any preselected consecutive measurements (e.g., 2, 3, 4, 5, 6, 7, 8, 9, or 10 consecutive measurements). In an example, the self-test can include detecting a fault if a temperature of the control circuitry 224 or any other circuitry of the wearable neural stimulation device 202 rises above a selected temperature (e.g., above about 35° C., above about 40° C., or above about 50° C.).
In an embodiment, the control circuitry 224 is configured to start a treatment session and end the treatment session. In an example, the control circuitry 224 can start a treatment session responsive to direction from the computing device 208 or the remote system 216, responsive to direction inputted into the wearable neural stimulation device 202 using a user interface (e.g., user interface 867 of
In an embodiment, the control circuitry 224, the computing device 208, and/or the remote system 216 can be configured to determine the onset of nerve accommodation and change the stimulus parameters responsive to determining the onset of nerve accommodation. In an example, the control circuitry 224, the computing device 208, and/or the remote system 216 can determine (e.g., predict) the onset of nerve accommodation based on historical data, such as when nerve accommodation began in previous instances of providing the stimulus. In an embodiment, the control circuitry 224, the computing device 208, and/or the remote system 216 are responsive to one or more characteristics sensed by the sensor 220 and/or another sensor. The one or more characteristics sensed by the sensor 220 and/or another sensor can include changes in bioelectrical activity of the nerve, changes in the physiologic condition of the subject 206 (e.g., heart rate variation, blood pressure changes, other cardiopulmonary parameters, etc.), or other characteristics. In an example, the control circuitry 224, the computing device 208, and/or the remote system 216 can be responsive to input received from the subject 206.
While the programs disclosed herein can be configured to prevent or inhibit nerve accommodation, the programs can also be configured to have different effects on the subject 206. For example, a program can be configured to cause the neural stimulators 212 and/or 222 to provide a first stimulus configured to cause a first effect on the subject 206 (e.g., treat a first condition) and provide a second stimulus configured to cause a second effect on the subject 206 (e.g., treat a second condition). The first stimulus can have different stimulus parameters than the second stimulus. In an embodiment, the programs can also be configured to have accumulative effects on the subject 206.
As previously discussed, the sensor 220 and/or another sensor can detect one or more characteristics of the subject 206. The detected characteristics can include any of the characteristics disclosed herein, such as a physiological characteristic (e.g., heart rate). In an embodiment, the characteristics detected by the sensor 220 and/or another sensor can be stored on the memory 226. In an embodiment, the characteristics detected by the sensor 220 and/or another sensor can be stored on the computing device 208 and/or the remote system 216 instead of or in conjunction with storing the characteristics on the memory 226. The characteristics stored on the memory 226, the computing device 208, and/or the remote system 216 can then be used to determine the effectiveness of the stimulus, the onset of nerve accommodation, how often the subject 206 is using the wearable neural stimulation device 202, etc. For example, a healthcare professional (e.g., a nurse, a nurse practitioner, a physician assistant, a doctor, an insurance company) can access the characteristics stored on the memory 226, the computing device 208, and/or the remote system 216. It is noted that the memory 226, the computing device 208, and/or the remote system 216 can also store additional information, such as information inputted into the control circuitry 224, the computing device 208, and/or the remote system 216 by the subject 206.
In an embodiment, the wearable neural stimulation device 202 (e.g., an earpiece) can include external-acoustics-handling means. In other words, the wearable neural stimulation device 202 can allow acoustic waves to pass through so that the subject 206 can hear at least a portion of an external sound. Such external-acoustics-handling means can include passive technologies or active technologies. An example of passive technologies can include housing designs, such as open canals (e.g., recesses 3225 or 3235 of
In an embodiment, the wearable neural stimulation device 202 can include noise-masking technology. In an embodiment, the wearable neural stimulation device 202 can include notification means (e.g., associated with clock, an alarm, or an alert).
As previously discussed, the system 200 (e.g., the wearable neural stimulation device 202) can be designed to deliver a stimulus configured to treat, prevent, or otherwise address a sleep disorder. In an embodiment, the system 200 includes means to generate and deliver a stimulus to the subject 206 that is configured to treat, prevent, or otherwise address a sleeping disorder. The means can include any of the neural stimulators disclosed herein. The stimulus can be configured to affect a nerve or muscle. For example, the stimulus can stimulate a vagal nerve, a glossopharyngeal nerve (e.g., to induce glossopharyngeal insufflation), a hypoglossal nerve (e.g., to stimulate upper airway muscles), a sensory nerve (e.g., a mechanoreceptor), a motor nerve, an autonomic nerve, another suitable nerve, branches thereof, or combinations thereof. In an example, the stimulus can stimulate an auditory system nerve, other auditory system cells (e.g., a hair cell), or the like. In an embodiment, the stimulus is configured to induce an acute or immediate effect. In an embodiment, the stimulus is configured to induce a latent effect or an accumulative effect. In an embodiment, the stimulus is an arousal stimulus, for example inducing activity in a body portion (e.g., respiratory system) of the subject 206 or in the subject 206 himself (e.g., arousal) when the subject is experiencing an apneic event. In an embodiment, the stimulus is a relaxant stimulus, for example, a stimulus (e.g., an auditory or electrical stimulus) may induce relaxation in a subject suffering from insomnia or may induce relaxation of a muscle in a sleep disorder with muscle dysfunction. In an embodiment, the stimulus is configured to signal the subject 206. For example, the stimulus may signal to the subject (e.g., the subject 206 has undergone training) to perform an action (e.g., roll over) when the stimulus is applied. In such an example, the action can be a subconscious action. In an embodiment, the system 200 includes an acoustic generator and speaker (e.g., sound source 856 of
In an embodiment, the system 200 includes at least one sensor (e.g., sensor 220 or any other sensor disclosed herein) configured to monitor the subject 206 to detect changes in the subject 206 indicative of one or more sleep-related episodes. In an embodiment, the system 200 is configured to monitor the subject 206 in real time to detect changes indicative of the onset of one or more sleep-related episodes. For example, the system 200 can monitor the subject 206 for changes indicative of immediate respiratory dysfunction such as an apneic episode. In an embodiment, the system 200 monitors the subject 206 over time to detect changes indicative of alterations in chronic sleep disorders. For example, the system 200 can monitor the subject 206 for changes indicative of an altered sleep pattern in a subject 206 with a chronic sleep disorder. In an embodiment, the system 200 can monitor the subject 206 over time to detect changes in the subject 206 indicative of one or more sleep-related episodes following application of a stimulation. For example, the system 200 can monitor the subject 206 for changes indicative of immediate respiratory dysfunction, apply a stimulation, and monitor for a change in the subject 206 such as a return to normal respiratory function. For example, the system 200 can monitor the subject 206 over time for changes indicative of an altered sleep pattern (e.g., fewer waking episodes per night) in a subject 206 with a chronic sleep disorder who has been following a regimen (e.g., daily stimulation via the system 200). In an embodiment, the system 200 comprises a loop system or a biofeedback system.
In an embodiment, the at least one sensor (e.g., sensor 220 or any other sensor disclosed herein) is configured to detect at least one of a body movement or lack of body movement (e.g., paralysis), a movement in a body portion or lack of movement in a body portion, a body sound, a vocal sound, or the like. In an embodiment, the at least one sensor includes at least one motion sensor configured to detect movement in the subject's 206 body or a portion thereof such as, a limb, a torso, a chest (e.g., during breathing), a head, an oronasopharyngeal tissue (e.g., mouth, throat or nasal tissue), an eye, etc. For example, a motion sensor can include an accelerometer, a pressure sensor, an optical sensor, or the like. In an embodiment, the at least one sensor includes at least one acoustic sensor. For example an acoustic sensor (e.g., microphone) can detect sounds associated with breathing including snoring or breath cessation. For example an acoustic sensor can detect a vocal sound (e.g., a groan during a nightmare). In an embodiment, the at least one sensor is configured to detect at least one physiological parameter such as but not limited to a heart rate, electrical activity of the brain (e.g., an electroencephalograph or electroculograph configured to monitor signals associated with the sleep stage), a respiratory rate, a cardiac parameter (e.g., an electrocardiograph), a respiratory action, a temperature (e.g., temperature changes that occur during sleep), oxygenation, a brain-related parameter (e.g., an electroencephalogram or an electro-oculogram), a nerve function parameter, skin conductance, or the like. In an embodiment, the at least one sensor includes at least one physiological sensor as described herein.
In an example, the wearable neural stimulation device 202 can exhibit a shape and fit that attaches the wearable neural stimulation device 202 to the ear 204 of the subject 206 which can allow the neural stimulator 212 and, optionally neural stimulator 222, to contact the ear 204. In an example, the wearable neural stimulation device 202 can operate while the subject 206 is moving. In an example, the wearable neural stimulation device 202 can exhibit a shape, size, or attachment mechanism that allows the wearable neural stimulation device 202 to at least one of be worn only in a certain ear 204, be worn in a certain orientation relative to the ear 204, or allow the wearable neural stimulation device 202 to be easily removed from the ear 204 (e.g., using a single action).
In an embodiment, the wearable neural stimulation device 202 can include housing that is configured to support and/or have disposed therein one or more components of the wearable neural stimulation device 202. The housing can exhibit (excluding any extensions extending therefrom) a height of about 1 cm to about 7 cm (e.g., about 2 cm to about 6 cm, about 3 cm to about 5 cm, or about 4 cm), a width of about 1 cm to about 6 cm (e.g., about 2 cm to about 5 cm, or about 3 cm), and a thickness of about 0.25 cm to about 3 cm (e.g., about 0.5 cm to about 2 cm or about 1 cm to about 2 cm). In an embodiment, the housing and any other components of the wearable neural stimulation device 202 can be formed of materials that meet the biocompatibility requirements of ISO 10993-1:2009 for surface device contacting intact skin.
In an embodiment, the neural stimulation device 202 (e.g., the housing and/or other components of the neural stimulation device 202) can be configured to be operated, stored (e.g., the wearable neural stimulation device 202 is powered off), or transported in certain environments. In an example, the wearable neural stimulation device 202 can be configured to suffer no degradation of performance following transportation and/or storage for 16 hours at each extremes of its labeled storage temperature range. The labeled storage temperature range can include at least one of about −25° C. to about 0° C., about −10° C. to about 10° C., about 0° C. to about 25° C., about 20° C. to about 40° C., about 30° C. to about 50° C., about 40° C. to about 60° C., about 50° C. to about 75° C., or about 70° C. to about 100° C. In an example, the wearable neural stimulation device 202 can be configured to suffer no degradation of performance following transportation and/or storage for 16 hours at each extremes of its labeled storage humidity range. In an example, the housing and/or the components of the wearable neural stimulation device 202 can be configured to suffer no degradation of performance following operating at each extreme of its labeled operational temperature range. The labeled operational temperature range can include at least one of about 0° C. to about 25° C., about 20° C. to about 40° C., about 30° C. to about 50° C., or about 40° C. to about 60° C. In an example, the wearable neural stimulation device 202 can be configured to suffer no degradation of performance when operated at each extreme of its labeled operational humidity range. In an example, the wearable neural stimulation device 202 can be configured to suffer no degradation of performance following operation at each extreme of its labeled operational pressure range. The labeled operational pressure range can include at least one of about 30 kPa to about 75 kPa, about 70 kPa to about 90 kPa, about 85 kPa to about 95 kPa, about 90 kPa to about 100 kPa, about 95 kPa to about 105 kPa, about 100 kPa to about 110 kPa, or about 105 kPa to about 125 kPa. In an example, the wearable neural stimulation device 202 can be configured to maintain basic safety and essential performance for at least 2 hours following a transition, within about 5 minutes, from its lowest labeled operating temperature and humidity to its highest labeled operating temperature and humidity, or vice versa. In an example, the wearable neural stimulation device 202 can be configured to maintain a temperature of an exterior surface thereof at or below 41° C., even when the wearable neural stimulation device 202 is operated at its highest labeled operating temperature (e.g., the highest labeled operating temperature is less than 41° C.). In an example, the wearable neural stimulation device 202 can be configured to maintain basic safety and essential performance following exposure to dripping water according to the IP2× test of IEC 60529:2013. In an example, the wearable neural stimulation device 202 can be configured to maintain basic safety and essential performance following application of a 12.5 mm test finger according to the IP2× test of IEC 60529:2013. In an example, the wearable neural stimulation device 202 can be configured to maintain basic safety and essential performance following application of a 250±10 N force to a circular planar surface exhibiting a diameter of 30 mm on an external part of the wearable neural stimulation device for 5 seconds. In an example, the wearable neural stimulation device 202 can be configured to maintain basic safety and essential performance following a free-fall of a solid, smooth, steel ball approximately 50 mm in diameter and with a mass of 500±25 g onto the wearable neural stimulation device from a height of at least 1.3 m. In an example, the wearable neural stimulation device 202 can be configured to maintain basic safety and essential performance following three free-fall drops from a height of at least 1.8 m In such an example, the drop surface can be a hardwood that is 50±5 mm thick, exhibits a density greater than 600 m3, and is lying flat on concrete or a similarly rigid base. In an example, the wearable neural stimulation device 202 can be configured to meet the mould stress relief requirements given in IEC 60601-1:2012 section 15.3.6. In an example, the wearable neural stimulation device 202 can be configured to maintain basic safety and essential performance following a shock test according to IEC 60068-2-27:2008 where the peak acceleration is 150 m/s2, the duration is 11 ms, pulse shape is half-size, and the number of shocks include 3 per direction per axis (18 total). In an example, the wearable neural stimulation device 202 can be configured to maintain basic safety and essential performance following a vibration test according to IEC 60068-2-64:2008. In an example, the wearable neural stimulation device 202 can be configured to exhibit no degradation of performance following at least 500 executions of the cleaning procedures described in the IFU: gentle wiping from a damp soft cloth with water and mild detergent. In an example, surface of the wearable neural stimulation device 202 that are exposed to the environment can be formed of at least one corrosion resistant material.
In an embodiment, the wearable neural stimulation device 202 can be configured to comply with certain electromagnetic compatibly requirements. In an example, the wearable neural stimulation device 202 can be configured to, except for wireless communication signals (e.g., Bluetooth transmission band, Wi-Fi signals, etc.) comply with the Radiated Emissions requirements for Group 1, Type B products established by CISPR 11. In an example, the wearable neural stimulation device 202 can, during standby or operation, be configured to meet certain performance criteria following electrostatic discharges at certain levels to certain contact points. The certain levels includes a contact discharge of ±8 kV and/or air discharge at one or more of ±2 kV, ±4 kV, ±8 kV, or ±15 kV. The certain contact points include at least one of outside of the housing, electrode contacts, or the charging port of the wearable neural stimulation device 202. In an example, the wearable neural stimulation device 202 can be configured to meet certain performance criteria during and after exposure to a radiated electromagnetic field exhibiting an intensity of 10 V/m over the frequency range of 80 MHz to about 2.7 GHz. In an example, the wearable neural stimulation device 202 can be configured to meet certain performance criteria during and after exposure to the magnetic fields specified in Table 9 of IEC 60601-1-2:2014.
Various examples and embodiments of wearable neural stimulation devices are described herein. In various aspects of neural stimulation systems described herein, the wearable neural stimulation devices are wearable, i.e. the device can be carried by or worn on the ear of a subject (e.g., the wearable neural stimulation device is not a handheld device), secured by a securing member, in order to position one or more neural stimulator with respect to a portion of the ear of the subject, or in some cases, in the vicinity of the ear of the subject. Various types of securing members may be used, without limitation. A securing member may also serve to position one or more sensors on or in the vicinity of the ear of the subject and may also include or support other system components, such as electrical circuitry components. In an embodiment, the neural Examples of neural stimulation devices including different types of securing members are shown in
The securing member 300′ includes neural stimulators 310a′, 310b′, and 310c′. In an embodiment, as shown, the neural stimulators 310a′ and 310b′ are configured to provide a transcutaneous electrical stimulus to the ear, and the stimulator 310c′ is configured to provide a different type of stimulus to the ear (e.g., a mechanical stimulus, an ultrasonic stimulus, a thermal stimulus). However, in other embodiments, at least one of the stimulators 310a′ or 310b′ can be configured to provide a different stimulus to the ear, and/or the stimulator 310c′ can be configured to provide a transcutaneous electrical stimulus to the ear.
The stimulators 310a′ and 310b′ can include first electrodes 330a and 330b, respectively, that are configured to contact a portion of an anterior surface of an pinna, such as the cymba and cevum of the concha of the pinna. The stimulators 310a′ and 310b′ can also include second electrodes 332a and 332b, respectively. The second electrodes 332a and 332b are configured to contact a portion of a posterior surface of the pinna that corresponds to the portion of the pinna that is contacted by the first electrodes 330a and 330b, respectively. As such, the stimulators 310a′ and 310b′ can provide the transcutaneous electrical stimulus (e.g., an electric field and/or electric current) to the ear.
The securing member 300′ can include one or more extensions 334. The one or more extensions 334 can include the second electrodes 332a and 332b disposed therein or thereon. The extensions 334 can also include one or more additional components of the securing member 300′ disposed therein or thereon, such as one or more sensors. The one or more extensions 334 can extend from a main body 336 of the securing member 300′ and around the ear such that the second electrodes 332a and 332b can contact the posterior surface of the pinna. For example, the extensions 334 can exhibit a hook-like shape. In an embodiment, as shown, the extensions 334 can exhibit two or more branches 338 and each of the branches 338 can include one of the second electrodes 332a and 332b. In another embodiment, the extensions 334 do not include branches 338. The extensions 334 allow the securing member 300′ to exhibit a more open configuration while still being able to contact the second electrodes 332a and 332b against selected portions of the pinna.
The extensions 334 can be configured to maintain the second electrodes 332a and 332b in contact with the posterior surface which can improve the operation of the neural stimulators 310a and 310b. In particular, maintaining the second electrodes 332a and 332b in contact with the posterior improves the operation of the neural stimulators 310a and 310b because a loose or intermittent connection between the posterior surface and the second electrodes 332a and 332b can lead to electrical shocks (e.g., if the stimulators 310a and 310b provide a constant electrical current leading to charge build up when connection is lost and discharge (shock) when it is reestablished) or decrease the transcutaneous electrical stimulus provided to the ear (e.g., if the stimulators 310a and 310b provide a constant voltage, resulting in a low stimulation current in the subject if there is a high resistance/impedance between the stimulator and the subject). In an embodiment, the extensions 334 can be suctioned to the posterior surface of the pinna thereby maintaining the second electrodes 332a and 332b in contact with the posterior surface. In an embodiment, the extensions 334 can exhibit a shape that causes the extensions 334 to press against the posterior surface when the securing member 300′ is positioned about the ear. In an embodiment, the extensions 334 can include an actuator 340 that is configured to maintain contact between the posterior surface and the second electrodes 332a and 332b. The actuator 340 can include any suitable actuator, such as a mechanical actuator (e.g., motor), an electroactive polymer, a shape memory material, an inflatable actuator, a pneumatic actuator, a hydraulic actuator, etc. The actuator 340 can actuate when at least one of the second electrodes 332a or 332b becomes spaced from the posterior surface such that the second electrode 332a or 332b maintains in contact with the posterior surface.
The securing member 300′ can include a contact sensor 342, as illustrated, that is configured to detect when at least one of the second electrode 332a or 332b does not contact the posterior surface. In an example, the contact sensor 342 can include a pressure sensor. In such an example, the contact sensor 342 can detect that the second electrode 332a or 332b does not contact the posterior surface when the contact sensor 342 detects a pressure that is less than about 0.1 psi, less than about 0.2 psi, or less than about 0.3 psi. In an example, the contact sensor 342 can be adjacent or proximate to at least one of the second electrode 332a or 332b. In another example, the contact sensor 342 can include a skin conductivity and/or skin capacitance sensor. In such an example, the contact sensor 342 can detect when at least one of the second electrodes 332a or 332b is spaced from the posterior surface, since the space can cause a change in detected conductivity or capacitance (e.g., when the contact sensor 342 is adjacent or proximate to at least one of the second electrodes 332a or 332b) and/or a change in the transcutaneous electrical stimulus that is detectable by the contact sensor 342. For example, charge or current flow can be monitored. If reduced current flow is detected, indicating a weaker contact, either amplitude or duration of a stimulus pulse can be increased to ensure that the desired level of charge or current flow into the tissue is obtained. In some embodiments, the contact sensor 342 senses a change in amplitude of a detected biological signal (e.g., a neural signal detected with an electrode), indicating insufficient contact of the electrode with the ear. In another example, the contact sensor can include an image sensor (e.g., a camera) that can visually detect a space between at least one of the second electrodes 332a or 332b or can detect when at least one of the second electrodes 332a or 332b is incorrectly positioned relative to a landmark on the posterior surface. In another example, the contact sensor 342 can include a temperature sensor positioned adjacent or proximate to at least one of the second electrodes 332a or 332b, since a temperature detected by the contact sensor 342 can vary depending on whether the contact sensor 342 contacts or is spaced from the ear. In an embodiment, responsive to detecting that at least one of the second electrodes 332a or 332b does not contact the posterior surface, the actuator 340 can actuates thereby ensuring that the second electrodes 332a and 332b contact a surface of the pinna, e.g. by pushing the second electrodes 332a and 332b against the surface of the pinna. In an embodiment, responsive to detecting that at least one of the second electrodes 332a or 332b does not contact the posterior surface, the securing member 300′ can provide a stimulus (e.g., auditory signal) indicating to the subject that the second electrode 332a or 332b is not contacting the posterior surface, so that the subject can adjust the position of the electrode.
In an embodiment, the contact sensor 342 can be used to determine how often a subject is using the securing member 300′ (e.g., using a wearable neural stimulation device that includes the securing member 300′). For example, the contact sensor 342 can determine when the subject is wearing or taking off the securing member 300′. This information can be used to determine at least one of whether the subject is complying with recommended usage, how long the subject is sleeping, how often the subject requires treatment, the emotional state of the subject (e.g., a subject who is receiving treatment for depression is more likely to wear the securing member 300′ when feeling depressed than happy), etc. It will be appreciated that contact sensor 342, as described in connection with secondary electrodes 332a and 332b, may alternatively, or in addition, be used in connection with primary electrodes 330a and 330b, or with other electrodes described herein.
In an embodiment, as shown, the first electrodes 330a and 330b are disposed in the body 336 of the securing member 330′. However, in another embodiment, at least one of the first electrodes 330a or 330b can be disposed in or on one or more extensions (not shown) that extend from the body 336. The one or more extensions that includes at least one of the first electrodes 330a or 330b can be substantially similar to the extension 334. For example, the one or more extensions that include at least one of the first electrodes 330a or 330b can include an actuator, a contact sensor, etc.
In an embodiment, the clip 312′ includes a neural stimulator 314′ that is configured to provide a transcutaneous electrical stimulus to the ear. As such, the neural stimulator 314′ can include a first electrode 330c that is configured to contact a portion of an anterior surface of a pinna and a second electrode 332c that is configured to contact a corresponding portion of the posterior surface of the pinna. In an embodiment, the clip 312′ includes one or more extensions 334′ extending from a body 344 of the clip 312′. The one or more extensions 334′ can include at least one of the first or second electrodes 330c and 332c disposed therein or thereon. The extensions 334′ can be configured to allow at least one of the first and second electrodes 330c or 332c to contact the portion of the anterior surface or the corresponding portion of the posterior surface, respectively, when the portion of the anterior surface or the corresponding portion of the posterior surface is spaced from the clip 312′. The extensions 334′ can be the same as or can be substantially similar to the extensions 334′. For example, the extensions 334′ can include an actuator (not shown), a contact sensor (e.g., the sensor 316), etc.
The securing member 400′ can include neural stimulators 410a′ and 410b′. In an embodiment, the stimulators 410a′ and 410b′ are configured to provide a transcutaneous electrical stimulus to the ear. As such, the neural stimulators 410a′ and 410b′ can include first electrodes 430a and 430b, respectively, that are configured to contact a portion the anterior surface of the pinna. The neural stimulators 410a′ and 410b′ can also include second electrodes 432a and 432b, respectively, that are configured to contact a portion of the posterior surface of the pinna that corresponds to the portion of the anterior surface that is contacted by the first electrodes 430a and 430b. In an embodiment, the securing member 400′ can include one or more extensions 434 when the anterior portion 404, the over ear portion 406, or the posterior portion 408 is spaced from the portions of the anterior surface and/or posterior surface that at least one of the first or second electrodes 430a, 430b, 432a, or 432b are supposed to contact. The extensions 434 can include at least one at least one of the first or second electrodes 430a, 430b, 432a, or 432b disposed therein or thereon, as needed. The extensions 434 can be the same as or can be similar to the extensions 334 and 334′ of
In some aspects, neural stimulator 512 located on pinna extension 514 can be used as the only, or primary neural stimulator, and neural stimulator 510 on earpiece 502a can be omitted. Earpieces 502a and 502b can function to hold securing member 500 in place with respect to the head of the subject, and, optionally, to deliver sound (such as a voice signal from a phone or music from an audio player) to the ears of the subject, independent of neural stimulator 510. Circuitry 516 in securing member 500 includes communication circuitry for wirelessly communicating with other system components, for example a computing device (e.g., an audio player, a mobile phone, or a laptop computer). In addition, circuitry 516 may provide for wireless communication with a sensor located at a distance from securing member 500. For example, the wireless headset device depicted in
In various aspects, neural signal sensor 702 can be an electroencephalographic signal sensor 712 or electrooculographic signal sensor 714. Electroencephalographic signal sensor 712 can be configured to fit within an ear canal of a subject, e.g., on an ear canal insert as depicted in
In various aspects, securing member 710 is configured to secure neural stimulator 706 to different portions of the pinna of the subject. For example, in an aspect, securing member 710 includes a concha-fitted portion 716, configured to fit into the concha of the subject (e.g., as depicted in
In an aspect, the securing member 710 is configured for comfort. For example, the securing member 710 can be configured to enable the neural stimulation system 700 to be worn while sleeping or for prolonged periods of time. In an embodiment, the securing member 710 can be custom fitted to a subject, thereby improving the comfort of the securing member 710 compared to a securing member that is not custom fitted. In such an embodiment, the ear (including the pinna and/or canal) of the subject can be scanned or an impression of the ear (including the pinna and/or canal) can be formed. The securing member 710 can then be manufactured to conform to the pinna and/or canal using the scan or impression.
In an aspect, the portions of the neural stimulation system 700 that is worn on the ear of the subject exhibits a weight that allows the neural stimulation system 700 to be worn comfortably on the ear. For example, the portions of the neural stimulation system 700 worn on the ear can exhibit a weight that is less than about 200 g, such as in ranges of about 1 g to about 10 g, about 5 g to about 20 g, about 10 g to about 30 g, about 20 g to about 40 g, about 30 g to about 50 g, about 40 g to about 70 g, about 60 g to about 100 g, about 90 g to about 150 g, or about 120 g to about 200 g. It is noted that decreasing the weight of the portions of the neural stimulation system 700 that is worn on the ear can increase the comfort of neural stimulation system 700.
In an embodiment, the securing member 710 can include a contact sensor (e.g., secondary sensor 750 including any of the contact sensors disclosed herein) that is configured to determine the pressure applied by the securing member 710 to the pinna. In such an embodiment, the securing member 710 can also include an actuator (not shown, e.g., any of the actuators disclosed herein) that, responsive to the characteristics sensed by the contact sensor, adjusts the pressure applied by the securing member 710 to improve the comfort of wearing the securing member 710. In an example, increasing the comfort of the securing member 710 may require minimizing the pressure applied to the pinna. However, minimizing the pressure applied to the pinna can cause a space to periodically develop between the neural stimulator 706 and/or 818 and a surface of the pinna. As such, the securing member 710 (e.g., the actuator) can be configured to apply a small pressure that is sufficient to maintain contact between the neural stimulator 706 and/or 818 and the pinna. In an example, the neural stimulator 706 and/or 818 can also include a conformable conductive material (e.g., conductive gel or a conductive polymer) thereon. The conformable conductive material can improve delivery of the stimulus to the pinna even if contact between the neural stimulator 706 and the pinna is poor.
In an embodiment, the securing member 710 can be formed from a flexible material such that the securing member 710 can bend to conform to the pinna thereby increasing the comfort of the securing member 710. In an embodiment, the securing member 710 can be configured to massage the subject, thereby improving the comfort of the securing member 710. For example, the securing member 710 can include a vibrator that is configured to massage the subject. In an embodiment, the securing member 710 can exhibit low friction (e.g., a smooth surface or be at least partially formed from a low friction material) or be padded, thereby increasing the comfort of the securing member 710.
In an embodiment, the securing member 710 and any other exposed surface of the neural stimulation system 700 can be configured to be decorated. In an example, the securing member 710 or any other exposed surface of the neural stimulation system 700 can be have rhinestones or similar decorations disposed therein. In an example, the securing member 710 or any other exposed surface of the neural stimulation system 700 can exhibit a surface (e.g., a flat surface) that can receive stickers (e.g., replaceable stickers). In an example, the securing member 710 or any other exposed surface of the neural stimulation system 700 can include an attachment mechanism that is configured to receive decorations, such as alternative skins. The attachment mechanism can include Velcro, hooks, protrusions, adhesives, recesses configured to receive protrusions from the decoration, etc. In an example, the securing member 710 or any other exposed surface of the neural stimulation system 700 can be configured to receive clip-on decorations. Allowing the securing member 710 or any other exposed surface of the neural stimulation system 700 to be decorated can encourage subjects to use the neural stimulation system 700, for example in pediatric and young adult subjects. Other examples of decorations can include jewelry or temporary or permanent designs (e.g., pop culture designs, or holiday designs).
In an embodiment, the securing member 710 and/or any component of the neural stimulation system 700 can be configured to be discrete. For example, the components of the securing member 710 and/or any other component of the neural stimulation system 700 can be configured to fit in the concha without significantly protruding out from the concha. For example, a majority (by volume) of the components of the securing member 710 and/or any other component of the neural stimulation system 700 can be configured to be disposed behind the pinna. For example, the neural stimulation system 700 can be configured to communicate wirelessly and, as such, the neural stimulation system 700 does not include a wire. For example, the securing member 710 and/or any other exposed surface of the neural stimulation system 700 is not decorated and/or is not configured to be decorated. For example, the components of the securing member 710 and/or any other component of the neural stimulation system 700 can be configured to resemble a commercial system used for delivering sound (e.g., phone or music earbuds).
In an aspect, the neural stimulator 706 is positioned with respect to securing member 710 such that when securing member 710 is worn on the pinna, neural stimulator 706 is positioned (secured) over a specific region of the pinna, e.g., a region of the pinna innervated by a cranial nerve, e.g., the vagus nerve, the facial nerve, the trigeminal nerve, or the glossopharyngeal nerve. Such positioning may be selected based upon knowledge of the innervation of the pinna, for example, as provided in references texts such as Cranial Nerves in Health and Disease, by Linda Wilson-Pauwels, Elizabeth J. Akesson, Patricia A. Stewart, and Sian D. Spacey; BC Decker Inc.; 2 edition (Jan. 1, 2002); ISBN-10: 1550091646/ISBN-13: 978-1550091649, which is incorporated herein by reference.
As noted above, neural stimulator 706 may be, for example, a mechanical stimulator 730 (e.g., a vibratory mechanical stimulator 732), a transcutaneous electrical stimulator 734, a transcutaneous magnetic stimulator 736, an ultrasonic stimulator 738, a chemical stimulator 740, a thermal stimulator 742, or other type of stimulator.
As shown in
In an embodiment, the acoustic sensor 790 is configured to enable a subject using the neural stimulation system 700 to interact with the neural stimulation system 700. In an embodiment, the acoustic sensor 790 in combination with the control/processing circuitry 846 and/or the computing device 852 can allow the subject to control the neural stimulation system 700 using voice commands (e.g., “start stimulation pattern A”, “switch to stimulation pattern B”, “stop”, etc.). In an embodiment, the acoustic sensor 790 allows the subject to provide subjective input about himself or herself, such as “I'm happy” or “I'm sad” The control/processing circuitry 846 of the neural stimulation system 700 can save the subjective characteristics in memory, can use the subjective characteristics to determine the onset of nerve accommodation, the effectiveness of the stimulation, etc. In an embodiment, the acoustic sensor 790 can be configured to detect one or more characteristics of a sleeping disorder, such as snoring or lack of breathing caused by sleep apnea.
In an embodiment, the neural signal sensor 702 and/or the secondary sensor 750 can be configured to detect the emotions of a subject using the neural stimulation system 700. The detection of the emotions of the subject can be used to determine the onset of nerve accommodation, the effectiveness of the stimulus, etc. In an example, the light sensor 782 can be configured to detect a facial expression of the individual. In such an example, the control/processing circuitry 846 and/or the computing device 852 can be configured to use the facial expressions to determine the emotional state of the subject. In an example, the neural signal sensor 702 and/or the secondary sensor 750 can include an electromyograph (e.g., a surface electromyograph) that is configured to detect facial expressions to determine the emotional state of the subject. In an example, the neural signal sensor 702 and/or the secondary sensor 750 can include at least one acoustic sensor that is configured to detect voice changes or nonverbal expressions (e.g., groans or moans) to determine the emotional state of the subject. In an example, the neural signal sensor 702 and/or the secondary sensor 750 can include an accelerometer that is configured to detect whether the subject is moving or is remaining stationary (e.g., lying around for prolonged periods of time), which can indicate the emotional state of the subject. Also or instead, the control/processing circuitry 846 and/or the computing device 852 can be configured to use facial expressions, voice changes or nonverbal expressions, or movement to determine the satisfaction of the subject, during or after use of the device.
In an aspect, neural stimulation system 700 includes a secondary signal input 800. In various aspects, the signal received at secondary signal input 800 includes a signal from a delivery device 802 (indicative of delivery of a drug or nutraceutical to the subject), an input to a game 804 (e.g., a signal corresponding to the subjects input to a video game played by the subject), an output from a game 806 (e.g., a signal output by a game system indicative of a state of or an event in a game played by the subject), a user input to a virtual reality system 808, an output from a virtual reality system 810 (e.g., a signal output by the VR system indicative of an state of or an event in the VR system), a user input device 812 (e.g., a user input device of a computing device or a user input to the neural stimulation system), or a computing device input 814 (e.g., a data input). Inputs received via a user input device or computing device input may be indicative of intake of a food item, beverage, nutraceutical, or pharmaceutical by the subject, for example. Inputs received via a user input device may be provided by the subject, or by another user, e.g. a medical caregiver. Inputs may be provided spontaneously by the user, or in response to a prompt or query. In an aspect, inputs may be provided by the user in response to queries or prompts that form a part of a quiz, questionnaire, or survey, including, e.g. questions presented in yes/no or multiple choice response format. User responses provided in response to such prompts or queries may indicate the subject's mental or emotional state. Inputs received via a data input may include, for example, health-related information of the subject, including genome information or microbiome information of the subject, information from medical-records of the subject, or other information pertaining to the health of the subject.
In an aspect, neural stimulation system 700 includes a clock or timer 816. In various aspects, neural stimulator 706 is adapted to produce stimulus 708 based at least in part on a time of day indicated by clock/timer 816, and/or based at least in part on a date indicated by clock/timer 816.
Data drawn from one or more neural signals, physiological signals, environmental signals, or other secondary signals (e.g. obtained with secondary sensor 750 in
In various aspects, neural stimulation system 700 includes at least one secondary stimulator 818 for delivery a secondary stimulus 820 to the subject. In an aspect, secondary stimulator 818 is a secondary neural stimulator 822, which may be any of the various types of neural stimulators described in connection with neural stimulator 706, and which may be of the same or different type as neural stimulator 706. Alternatively, secondary stimulator 818 may include a mechanical stimulator 824, an audio player 826, an auditory stimulus source 828, a virtual reality system 830, an augmented reality system 832, a visual stimulus source 834, a tactile stimulator 836, a haptic stimulator 838, an odorant source 840, a virtual therapist, or a delivery device 844, for delivering a drug or nutraceutical, for example.
In various aspects, neural stimulation system 700 includes control/processing circuitry 846 carried by securing member 710 (either directly on securing member 710, or on an extension or housing connected to securing member 710, e.g., as depicted in
In an aspect, neural stimulation system 700 includes communication circuitry 848 carried by securing member 710 and configured for at least one of sending one or more signal 850 to a computing device 852 and receiving one or more signal 854 from computing device 852. In an example, the communication circuitry 848 can be configured to exchange information (e.g., detected fault conditions) with the computing device 852. The communication circuitry 848 can be configured to wirelessly (e.g., Bluetooth, Wi-Fi) or wiredly communicate with the computing device 852. In an embodiment, when the communication circuity 848 includes Bluetooth circuitry, the communication circuitry 848 can act as a peripheral device, advertising itself to scanning Bluetooth devices. In an embodiment, any communications between the communication circuitry 848 and the computing device 852 is encrypted to avoid vulnerability to man-in-the-middle attacks.
In an embodiment, the communication circuitry 848 requires the computing device 852 to be associated therewith (e.g., bonded or paired when the communication circuitry 848 is a Bluetooth device) before the communication circuitry 848 transmits information to the computing device 852 or receives information (e.g., instructions) from the computing device 852. In an example, associating the communication circuitry 848 with the computing device 852 includes identifying the computing device 852. In an example, associating the communication circuitry 848 with the computing device 852 includes some level of user interaction. The user interaction can include selecting the wearable neural stimulation device from a list, entering a passcode (e.g., a passcode unique to the wearable neural stimulation device), etc. In an embodiment, associating the communication circuitry 848 with the computing device 852 allows the communication circuitry 852 to reestablish communications with the computing device 852 without requiring subsequent user interaction. In an embodiment, the communication circuitry 848 and the computing device 852 can be configured to be dissociated. In an embodiment, the wearable neural stimulation device randomizes its wireless address information upon association with the computing device 852 and/or daily thereafter thereby making it more difficult to track the subject using the wearable neural stimulation device.
In an embodiment, the communication circuitry 848 can be associated with a plurality of computing devices, such as associated with up to four computing devices. In such an embodiment, once a treatment session has been initiated by a command from the computing device 852, the neural stimulation system 700 may not receive and/or respond to commands from another computing device until the treatment session has been terminated.
In an aspect, neural stimulation system 700 includes a sound source 856, for delivering an auditory signal to the subject. Sound source 856 may be, for example, a speaker 858. Sound source 856 may be configured (e.g., with appropriate electronic circuitry, not shown) to delivery an instruction 860 or alert 862 to the subject, such as an alert that the neural stimulator 706 or the secondary stimulator 818 is not contacting a surface of the pinna. The sound source 856 can also be configured to provide audible output (e.g., music, a lullaby to the subject to keep the subject asleep, an alarm to wake the subject up or mark end of a session, speech such as an audible book or learning materials, or other sounds) to the subject.
In an aspect, neural stimulation system 700 includes position sensor 864 for sensing the position of neural stimulator 706 with respect to the pinna of the subject. Position sensor 864 may detect the position of neural stimulator 706 with respect to the pinna by detecting electrical activity from a nerve, by detecting an image of the ear and determining the position based on landmarks in the image, or by detecting a temperature, pressure, or capacitive signal indicative of adequate contact of the stimulator with the ear, for example.
In an aspect, neural stimulation system 700 includes connector 866 for connecting the neural stimulator to a computing device. Connector 866 includes, for example, a jack or port for creating a wired (cable) connection with the computing device.
In an aspect, neural stimulation system 700 includes user interface 867 for receiving input from the subject or presenting information to the subject. The user interface 867 can increase the autonomy of the neural stimulation system 700. The subject can communicate directly with the neural stimulation system 700 (e.g., the subject can select a stimulation pattern stored in the control/processing circuitry 846, switch stimulation patterns, start a stimulation pattern, etc.). In an aspect, user interface 867 includes one or more of a small display (e.g., a touch screen), one or more indicator lights and simple user inputs, such as one or more buttons or dials for adjusting device setting and viewing and modifying system settings. For example, the user interface 867 can indicate at least one of the power status (e.g., whether the neural stimulation system 700 is on or off), battery status (e.g., low battery, battery fully charged, battery charging), warnings or errors (e.g., immediate response by the subject or other individual is required or recommended), treatment status (e.g., treatment is active, paused, resumed, or ended), the neural stimulation system 700 being ready to use. In an example, the user interface 867 can include a power button or a pause button. In an embodiment, the user interface 867 can be used to obtain subjective characteristics about the subject. For example, the user interface 867 can allow the subject to indicate the mood of the subject, the activities of the subject, how well the subject slept, etc. The control/processing circuitry 846 can be configured to use the subjective characteristics to determine the onset of nerve accommodation, the effectiveness of the stimulus, etc.
In an embodiment, the neural stimulation system 700 can be configured to treat a sleeping disorder, such as sleep apnea or snoring. In such an embodiment, the neural signal sensor 702 or the secondary sensor 750 can be configured to detect one or more characteristics of a sleeping disorder. In an example, the characteristics of the sleeping disorder can include snoring or lack of breathing that can be detected by the acoustic sensor 790 or the motion sensor 794. In an example, the characteristics of the sleeping disorder can be the position of the subject (e.g., is the subject sleeping on his side or back) with a motion sensor 794 or a location sensor 796. In an example, the characteristics of the sleeping disorder can be the movement of the subject or a body part of a subject (e.g., is the subject moving too much or not moving, is the subject experiencing muscle spasms, etc.) with an accelerometer. In an embodiment, responsive to detecting the characteristics of the sleeping disorder, the neural stimulator 706 or the secondary stimulator 818 can provide stimulus to the subject that causes the subject to wake up or to perform a subconscious action. In an example, the stimulus can be an audible signal from the audio player 826 that causes the individual to wake up or to perform a subconscious action. In an example, the stimulus can include any other stimulus disclosed herein that is configured to wake up the subject or to cause the subject to perform a subconscious action.
Circuitry-based system 870, which in some aspects is a computing device or computing subsystem, includes control/processing circuitry 874, which includes any or all of digital and/or analog components 876, one or more processor 878 (e.g., a microprocessor), and memory 880, which may store one or more program module 882 and/or data 884. In some aspects, control/processing circuitry 874 provides for preliminary handling of data from one or more sensors 886 (e.g., neural signal sensor 702 and/or secondary sensor 750 of
The system 800 can be configured to comply with all relevant government and ethical regulations, such as the Health Insurance Portability and Accountability Act (HIPAA), when transmitting information between the component thereof. For example, the system 800 can be configured to authenticate at least one of the computing device 899, the remote system 896, the user interface 894, or the control/processing circuitry 872 before transmitting information. In an example, the system 800 can be configured to encrypt any information before transmitting the information. In an example, the system 800 can be configured to verify that at least one of the computing device 899, the remote system 896, the user interface 894, or the control/processing circuitry 872 is authorized to receive the information before transmitting the information. In an example, at least one of the computing device 899, the remote system 896, the user interface 894, or the control/processing circuitry 872 can include firewalls to prevent unauthorized access to the information.
In an embodiment, the program modules 882 can include one or more stimulation patterns. For example, the program modules 882 can include a first stimulation pattern 883a, a second stimulation pattern 883b, and a third stimulation pattern 883c. It is noted that the program modules 882 can include more or fewer stimulation patterns. Each of the stimulation patterns of the program modules 882 is different. In an embodiment, the control/processing circuitry 872 can select one of the stimulation patterns to prevent or inhibit nerve accommodation. For example, the control/processing circuitry 872 can switch from the first stimulation pattern 883a to the second stimulation pattern 883b when the control/processing circuitry 872 detects the onset of nerve accommodation or after a selected period of time. In an embodiment, the control/processing circuitry 872 can select one of the stimulation patterns based on input received from the user via the user interface 894. In an embodiment, the control/processing circuitry 872 can select one of the stimulation patterns based on signals received from the remote device 896 and/or the computing device 899. In an embodiment, the memory 880 can include at least one playlist 885 stored thereon. The playlist 885 includes a selection of instructions regarding two or more of the stimulation patterns, a sequence that the stimulation patterns are to be performed, and/or a duration that the stimulation patterns are to be performed. The control/processing circuitry 872 can select the stimulation pattern based on the playlist 885. In embodiments, the playlist 885 can include a playlist optimized for a specific individual or a specific condition. For example, the playlist 885 can include a playlist designed by a third party (e.g., a proprietary playlist offered as an add on via download (e.g. via a website or network) or removable memory). In some examples, the playlist may be fully designed (e.g., optimized) prior to adding to the memory, while in other examples the playlist may be alterable, allowing the subject, medical care provider, company, or other actor to alter the playlist, e.g., to further optimize for efficacy or user preference, to upgrade playlist, etc. For example, the playlist 885 can include a playlist optimized based on a group or population, and the playlist can be further optimized for the individual subject.
The user interface 894 allows an individual (e.g., a subject using the wearable neural stimulation device, a caregiver, a medical professional, etc.) to at least partially control the operation of the circuitry-based system 872 and, more particularly, at least partially control the operation of the wearable neural stimulation device that is at least partially controlled by the circuitry-based system 872. The user interface 894 can allow the subject to select a stimulation pattern, select a playlist, execute a program module 882, stop an operation, modify or create a playlist (e.g., playlist 885), etc. The user interface 894 can also provide information to the subject, such as displaying the characteristics sensed by the sensor 886, the stimulation pattern being executed, etc.
In an embodiment, the user interface 894 can include buttons, a touch screen, etc. on the wearable neural stimulation device. In such an embodiment, the user interface 894 decreases the amount of communication needed between the wearable neural stimulation device and the remote device 896 and/or the computing device 899. In an embodiment, the user interface 894 can be on the remote device 896 and/or the computing device 899.
In an embodiment, the control/processing circuitry 872 can be configured to adjust the stimulus provided by the wearable neural stimulation device responsive to the sensor 886 detecting one or more characteristics. In particular, the control/processing circuitry 872 can adjust the program module 882 (e.g., select or change the stimulation pattern) responsive to the sensor 886 detecting one or more characteristics. In an example, the sensor can detect the heart rate of a subject wearing the wearable neural stimulation device (e.g., stimulating the vagus nerve can cause variations in the heart rate). The control/processing circuitry 872 can determine the effectiveness of the stimulus based on the detected heart rate. For instance, a variation in the heart rate can indicate that the wearable neural stimulation device is stimulating the vagus nerve or can indicate the onset of nerve accommodation. The control/processing circuitry 872 can adjust the stimulus responsive to detecting at least two heart beats, such as in ranges of 2-4, 3-5, 4-6, 5-7, 6-8, 7-9, 8-10, 9-12, 10-15, 12-17, 15-20, or more than 20 heart beats. Ideally, the control/processing circuitry 872 can adjust the stimulus responsive to detecting a large number of heart beats (e.g., at least 12, at least 15, or at least 20 heart beats) to verify that any variation in heart beats is not an anomaly. Stimulating the vagus nerve can affect the mood of the individual; in an example the control/processing circuitry 872 can adjust the stimulus responsive to a small sample size of heart beats (e.g., less than 12, less than 8, or less than 4 heart beats) thereby ensuring that the subject wearing the wearable neural stimulator device is appropriately stimulated as therapeutically indicated for mood. In an example, the control/processing circuitry 872 can use historical data (e.g., data 884) to determine whether to adjust the stimulus. In such an example, the control/processing circuitry 872 can compare the characteristics detected by the sensor 886 with historical data to determine whether to adjust the stimulus.
In an embodiment, the control/processing circuitry 872 can control the wearable neural stimulator device responsive to direction from medical provider (e.g., medical personnel, nurse, nurse practitioner, physician assistant, or doctor), service provider, or other caretaker. For example, the remote device 896 or the computing device 899 can be controlled or accessed by the medical personnel. In such an example, the medical personnel can upload instructions to the remote device 896 or the computing device 899 that directs the control/processing circuitry 872 to control the wearable neural stimulator device in a specific manner. The instructions can then be sent to the control/processing circuitry 872, and/or the instructions can be stored on the memory 880. In an example, the instructions uploaded into the remote device 896 or the computing device 899 can include specific program modules (e.g., specific stimulation patterns), specific playlists, etc. The specific program modules, specific playlists, etc. uploaded by the medical personnel can be specifically tailored for the subject using the wearable neural stimulation device, configured to treat a specific disorder, configured to prevent nerve accommodation, configured to prevent masking of other disorders (e.g., undiagnosed disorders), configured to function as part of a therapy regimen, etc. In an example, the instructions uploaded into the remote device 896 can include a prescription that limits the number of uses of the wearable neural stimulation device, the total duration that the wearable neural stimulation device can be used, when the wearable neural stimulation device can be used, etc. The prescription can be also used to require the subject using the wearable neural stimulation device to have regular or scheduled visits with the medical personnel for further treatments and/or to prevent the subject from excessively using the wearable neural stimulation device. The instructions uploaded into the remote device 896 can include instructions that allow use of the wearable neural stimulation device to be integrated into a larger therapy regimen. For example, the prescription can be used to require the subject to complete a particular therapeutic exercise (e.g., Cognitive Behavioral Therapy exercise, a Mindfulness exercise, an Acceptance and Commitment Therapy exercise, a Post-Traumatic Stress Disorder Therapy exercise, or the like) prior to, during, or after using the wearable neural stimulation device. In one instance, a playlist is not accessible without a code; the code is provided by the medium (e.g., a website, a workbook, a virtual environment, or a therapist) used to deliver and/or monitor the therapeutic exercise, and the subject or provider enters the code into the computing device 899 thereby allowing the playlist to play. In yet another example, the medical personnel can monitor the subject's progress and make determinations about changing the prescription. In such an example, the medical personnel can upload altered or new instructions to the remote device 896 or the computing device 899 that directs the control/processing circuitry 872 based on the determinations. In an embodiment, the instructions uploaded into the remote device 896 can include instructions for calibrating and/or optimizing for individual use, for example for use in calibrating or optimizing at initial use, prior to each use, or occasionally. In such an example, the instructions can be uploaded to the remote device 896 or the computing device 899 and/or stored on memory 880. In an embodiment, the instructions uploaded into the remote device 896 or the computing device 899 can include incentives; such incentives might include free playlists, coupons, merchandise, etc. In some instances, instructions can include upgrades
In an embodiment, the control/processing circuitry 872 can transmit information to the medical personnel (e.g., transmit information to the remote device 896 or the computing device 899). The information can include information about the subject's use of the wearable neural stimulation device, the characteristics detected by sensor 886, or any other suitable information. The medical personnel can use the provided information to adjust the instructions that were previously sent to the control/processing circuitry 872 or send new instructions to the control/processing circuitry 872. In an embodiment, the system 870 can be utilized as part of a telemedicine conference with the medical personnel.
In an embodiment, the power supply 890 can include a power source (e.g., a battery), such as when the control/processing circuitry 872 is at least partially disposed in a wireless wearable neural stimulation device. In such an embodiment, the power source (e.g., a battery) can include enough energy to power the control/processing circuitry 872 and the neural stimulator(s) of the wireless wearable neural stimulation device. For example, the battery can be configured to provide a voltage that is greater than the voltage of a transcutaneous electrical stimulus provided by the neural stimulator or the power supply 890 can include a voltage multiplier.
In an embodiment, the power source can include a single use battery that is configured to have enough energy to power the wireless wearable neural stimulation device for at least about 5 hours, at least about 10 hours, at least about 25 hours, at least about 50 hours, or at least about 100 hours. In an embodiment, the power source can include at least one of a thin film batter, a fuel cell, a solar cell, an energy harvester, or the like.
In an embodiment, the battery can include a rechargeable battery. The rechargeable battery can be configured to have enough energy to power the wireless wearable neural stimulation device for at least about 2 hours, at least about 4 hours, at least about 6, at least about 8, at least about 10, or at least about 12 hours without charging. In an embodiment, the wearable neural stimulation device is configured to provide a treatment session that is about 5 minutes to about 20 minutes, about 10 minutes to about 30 minutes, about 20 minutes to about 40 minutes, about 30 minutes to about 50 minutes, about 40 minutes to about 60 minutes, at least about 15 minutes, at least about 30 minutes, at least 45 minutes, at least 60 minutes, up to about 15 minutes, up to about 30 minutes, up to about 40 minutes, up to about 50 minutes, or up to about 60 minutes. In such an embodiment, the rechargeable battery can be configured to have enough energy to power the wireless wearable neural stimulation device for at least 1 session, at least 2 sessions, at least 3 sessions, at least 4 sessions, at least 5 sessions, up to 3 sessions, up to 4 sessions, or up to 5 sessions per day per charge. Further, the rechargeable battery can be configured to provide at least 500 treatments, at least 750 treatments, or at least 1000 treatments before the rechargeable battery needs to be replaced.
In an embodiment, the system 870 can include a battery charger when the power supply 890 includes a rechargeable battery. The battery charger and/or the rechargeable battery can be configured to completely charge the rechargeable battery (e.g., from 5% to 95% remaining charge) in no more than about 30 minutes, no more than about 45 minutes, no more than about 1 hour, no more than about 1.25 hours, no more than about 1.5 hours, no more than about 2 hours, or no more than about 3 hours. The battery charger can be configured to be coupled to and provide electrical power to the wearable neural stimulation device.
In an embodiment, the battery charger can also be configured as a carrying case for the wearable neural stimulation device. In such an embodiment, the battery case can include an attachment mechanism (e.g., recess, mechanical device, magnet, etc.) that is configured to receive and securably hold the wearable neural stimulation device 202. For example, the attachment mechanism can be configured to receive and securably hold the wearable neural stimulation device 202 without requiring the application of additional force or only requiring the application of a small additional force. The attachment mechanism can include aligning features and/or mating features that cause the wearable neural stimulation device to make electrical contact with the battery charger thereby allowing the battery charger to charge the rechargeable battery. The attachment mechanism can be configured to require a small external force to remove the wearable neural stimulation device therefrom. The small external force can be about 0.2 Newtons to about 38 Newtons, which can sufficient to prevent gravity from removing the wearable neural stimulation device from the attachment mechanism and is sufficiently small that most individuals would be able to remove the wearable neural stimulation device from the attachment mechanism. The battery charger can be configured to be a body worn device (e.g., the battery charger is configured to be positioned in a pocket).
In a general sense, the various embodiments described herein can be implemented, individually and/or collectively, by various types of electrical circuitry having a wide range of electrical components such as hardware, software, firmware, and/or virtually any combination thereof. Electrical circuitry (including control circuitry 224 of
In a general sense, the various aspects described herein which can be implemented, individually and/or collectively, by a wide range of hardware, software, firmware, and/or any combination thereof can be viewed as being composed of various types of “electrical circuitry.”
At least a portion of the devices and/or processes described herein can be integrated into a data processing system. A data processing system generally includes one or more of a system unit housing, a video display, memory such as volatile or non-volatile memory, processors such as microprocessors or digital signal processors, computational entities such as operating systems, drivers, graphical user interfaces, and applications programs, one or more interaction devices (e.g., a touch pad, a touch screen, an antenna, etc.), and/or control systems including feedback loops and control motors (e.g., feedback for sensing position and/or velocity; control motors for moving and/or adjusting components and/or quantities). A data processing system may be implemented utilizing suitable commercially available components, such as those typically found in data computing/communication and/or network computing/communication systems.
In various embodiments, methods as described herein may be performed according to instructions implementable in hardware, software, and/or firmware. Such instructions may be stored in non-transitory machine-readable data storage media, for example. The state of the art has progressed to the point where there is little distinction left between hardware, software, and/or firmware implementations of aspects of systems; the use of hardware, software, and/or firmware is generally (but not always, in that in certain contexts the choice between hardware and software can become significant) a design choice representing cost vs. efficiency tradeoffs. There are various vehicles by which processes and/or systems and/or other technologies described herein can be effected (e.g., hardware, software, and/or firmware), and that the preferred vehicle will vary with the context in which the processes and/or systems and/or other technologies are deployed. For example, if an implementer determines that speed and accuracy are paramount, the implementer may opt for a mainly hardware and/or firmware vehicle; alternatively, if flexibility is paramount, the implementer may opt for a mainly software implementation; or, yet again alternatively, the implementer may opt for some combination of hardware, software, and/or firmware in one or more machines, compositions of matter, and articles of manufacture. Hence, there are several possible vehicles by which the processes and/or devices and/or other technologies described herein may be effected, none of which is inherently superior to the other in that any vehicle to be utilized is a choice dependent upon the context in which the vehicle will be deployed and the specific concerns (e.g., speed, flexibility, or predictability) of the implementer, any of which may vary. Optical aspects of implementations will typically employ optically-oriented hardware, software, and or firmware.
In some implementations described herein, logic and similar implementations may include software or other control structures. Electrical circuitry, for example, may have one or more paths of electrical current constructed and arranged to implement various functions as described herein. In some implementations, one or more media may be configured to bear a device-detectable implementation when such media hold or transmit device detectable instructions operable to perform as described herein. In some variants, for example, implementations may include an update or modification of existing software or firmware, or of gate arrays or programmable hardware, such as by performing a reception of or a transmission of one or more instructions in relation to one or more operations described herein. Alternatively or additionally, in some variants, an implementation may include special-purpose hardware, software, firmware components, and/or general-purpose components executing or otherwise invoking special-purpose components.
Implementations may include executing a special-purpose instruction sequence or invoking circuitry for enabling, triggering, coordinating, requesting, or otherwise causing one or more occurrences of virtually any functional operations described herein. In some variants, operational or other logical descriptions herein may be expressed as source code and compiled or otherwise invoked as an executable instruction sequence. In some contexts, for example, implementations may be provided, in whole or in part, by source code, such as C++, or other code sequences. In other implementations, source or other code implementation, using commercially available and/or techniques in the art, may be compiled/ /implemented/translated/converted into a high-level descriptor language (e.g., initially implementing described technologies in C or C++ programming language and thereafter converting the programming language implementation into a logic-synthesizable language implementation, a hardware description language implementation, a hardware design simulation implementation, and/or other such similar mode(s) of expression). For example, some or all of a logical expression (e.g., computer programming language implementation) may be manifested as a Verilog-type hardware description (e.g., via Hardware Description Language (HDL) and/or Very High Speed Integrated Circuit Hardware Descriptor Language (VHDL)) or other circuitry model which may then be used to create a physical implementation having hardware (e.g., an Application Specific Integrated Circuit).
This detailed description sets forth various embodiments of devices and/or processes via the use of block diagrams, flowcharts, and/or examples. Insofar as such block diagrams, flowcharts, and/or examples contain one or more functions and/or operations, each function and/or operation within such block diagrams, flowcharts, or examples can be implemented, individually and/or collectively, by a wide range of hardware, software, firmware, or virtually any combination thereof. In an embodiment, several portions of the subject matter described herein may be implemented via Application Specific Integrated Circuits (ASICs), Field Programmable Gate Arrays (FPGAs), digital signal processors (DSPs), or other integrated formats. However, some aspects of the embodiments disclosed herein, in whole or in part, can be equivalently implemented in integrated circuits, as one or more computer programs running on one or more computers (e.g., as one or more programs running on one or more computer systems), as one or more programs running on one or more processors (e.g., as one or more programs running on one or more microprocessors), as firmware, or as virtually any combination thereof, and that designing the circuitry and/or writing the code for the software and or firmware would be well within the skill of one of skill in the art in light of this disclosure. In addition, the mechanisms of the subject matter described herein are capable of being distributed as a program product in a variety of forms, and that an illustrative embodiment of the subject matter described herein applies regardless of the particular type of signal bearing medium used to actually carry out the distribution. Examples of a signal bearing medium include, but are not limited to non-transitory machine-readable data storage media such as a recordable type medium such as a floppy disk, a hard disk drive, a Compact Disc (CD), a Digital Video Disk (DVD), a digital tape, a computer memory, etc.. A signal bearing medium may also include transmission type medium such as a digital and/or an analog communication medium (e.g., a fiber optic cable, a waveguide, a wired communications link, a wireless communication link (e.g., transmitter, receiver, transmission logic, reception logic, etc.) and so forth).
In an aspect, the neural stimulus is delivered with a neural stimulation device and/or neural stimulus configured to activate a cranial nerve, such as the vagus nerve, facial nerve, trigeminal nerve, or glossopharyngeal nerve. The neural stimulation device can be configured to stimulate a particular nerve by one or both of positioning the neural stimulator on at least a portion of a receptive field of the nerve of interest, and selecting the amplitude and other stimulus parameters (e.g. frequency, waveform, duration) of the stimulus delivered to activate the nerve fibers in the nerve of interest.
In an aspect, the method includes delivering the neural stimulus responsive to the at least one parameter of the sensed neural signal. The at least one parameter may include, for example, a frequency content of an electroencephalographic signal, an amplitude of an electroencephalographic signal, a rate of eye movement determined from an electrooculogram, or a gaze direction determined from an electrooculogram. In some aspects, such parameters are indicative of a brain-related disorder, or symptoms thereof. In an aspect, method 900 includes delivering the neural stimulus in response to detection of symptoms of a brain-related disorder (which may be, for example, any mental health disorder (e.g., psychological or psychiatric disorder), depression, post-traumatic stress disorder, seasonal affective disorder, anxiety, headache (e.g., primary headache, cluster headache, or migraine headache), or epilepsy). In an aspect, the method includes delivering the neural stimulus until symptoms of the brain-related disorder are no longer detected.
In an aspect, method 900 includes sensing at least one secondary signal with a secondary sensor. In an aspect, delivery of the neural stimulus may be started, stopped, or modulated in response to the secondary signal. The secondary signal may be a secondary neural signal (of the same or different type and sensed from the same or from a different location than the primary neural signal), or it may another type of physiological signal, an environmental signal, a location signal, or a signal from a motion sensor, for example. Such secondary signals may provide additional information relevant for determining whether the neural stimulus should be applied, assessing the subject's response to the neural stimulus, identifying appropriate time of delivery of the neural stimulus, etc. The secondary signal may include other types of secondary signal, e.g., as received by secondary signal input 800 in
In an aspect, neural stimulation device 1000 includes at least one sensor 1020, which may be any of the various types of sensors described in connection with secondary sensor 750 in
In an aspect, the vibratory mechanical stimulus has a waveform sufficient to modulate the activity of the at least one mechanoreceptor with a receptive field on the at least a portion of the pinna. For example, the vibratory mechanical stimulus may have a sinusoidal or other waveform. In some aspects, the vibratory mechanical stimulus is delivered according to programmed stimulation pattern, which may include delivering the vibratory mechanical stimulus either continuously or intermittently.
In an aspect, as indicated at 1106, method 1100 includes sensing a signal with a sensor and controlling the delivery of the vibratory mechanical stimulus based at least in part on the sensed signal. The sensed signal may be any of the various types of signal sensed with sensor 1020 in
In an aspect, method 1100 includes receiving a signal from an input and controlling the delivery of the vibratory mechanical stimulus based at least in part on the received signal, as indicated at 1108. The received signal may be e.g., any of the various types of input signals received at secondary signal input 800 in
In an aspect, method 1100 includes sensing at least one second sensed signal with a second sensor and controlling the delivery of the vibratory mechanical stimulus based at least in part on the second sensed signal, as indicated at 1110.
In an aspect, method 1100 also includes delivering a secondary stimulus to the subject, as indicated at 1112, which may include delivering a secondary stimulus with a secondary stimulator 818, as described in connection with
As discussed in connection with method 900, the vibratory mechanical stimulus can be delivered in response to detection of symptoms of a brain-related disorder, which may include, for example, a mental health disorder, depression, post-traumatic stress disorder, seasonal affective disorder, anxiety, headache, or epilepsy. In an aspect, method 1100 includes delivering the vibratory mechanical stimulus until symptoms of the brain-related disorder are no longer detected.
Computing device 1204 includes a user interface 1214 for at least one of presenting information to and receiving information from a user, control circuitry 1216 operatively connected to user interface 1214, and second communication circuitry 1218 configured for at least one of sending a signal to and receiving a signal from the first communication circuitry 1208 carried by the housing of the wearable neural stimulation device. In addition, computing device 1204 includes instructions 1220 that when executed on computing device 1204 cause computing device 1204 to perform at least one of sending signal 1212 to and receiving signal 1210 from wearable neural stimulation device 1204 via second communication circuitry 1218.
Communication circuitry 1208 and communication circuitry 1218 provide for communication between wearable neural stimulation device 1204 and computing device 1204. In addition, in some aspects one or both of communication circuitry 1208 and communication circuitry 1218 provide for communication of wearable neural stimulation device 1204 or computing device 1204, respectively, with a remote system 1224. In some aspects, communication circuitry 1208 and communication circuitry 1218 provide for wired communication between wearable neural stimulation device and computing device 1204. Wired communication to wearable neural stimulation device may occur via connector 866. Alternatively, or in addition, a wireless communication link may be established between wearable neural stimulation device 1204 and computing device 1204, and/or between either wearable neural stimulation device 1204 or computing device 1204 and remote system 1224. In various aspects, a wireless communication link includes at least one of a radio frequency, wireless network, cellular network, satellite, WiFi, BlueTooth (e.g., Bluetooth low energy), Wide Area Network, Local Area Network, or Body Area Network communication link. Various types of communication links are suitable for providing communication between two remote locations. Communication between locations remote from each other may take place over telecommunications networks, for example public or private Wide Area Network (WAN). In general, communication between remote locations is not considered to be suitably handled by technologies geared towards physically localized networks, e.g., Local Area Network (LAN) technologies operation at Layer ½ (such as the forms of Ethernet or WiFi). However, it will be appreciated that portions (but not the entirety) of communication networks used in remote communications may include technologies suitable for use in physically localized network, such as Ethernet or WiFi.
In an aspect, computing device 1204 is personal digital assistant 1226, a personal entertainment device 1228, a mobile phone 1230, a laptop computer 1232, a personal computer 1234 (e.g., a tablet personal computer), a wearable computing device 1236 (e.g., a fitness band, an item of clothing, attire, or eyewear incorporating computing capability), a networked computer 1238, a computing system comprising a cluster of processors 1240, a computing system comprising a cluster of servers 1242, a workstation computer 1244, a desktop computer 1246, a kiosk 1248, a mobile healthcare platform 1250, and/or an external healthcare network 1252. In various aspects, computing device 1204 includes one or more of a portable computing device, a wearable computing device, a mobile computing device, and a thin client computing device, for example. It is noted that the remote system 1224 can include the same or similar device as the computing device 1204.
Neural activity signal input 1304 (the circuitry for receiving neural activity signal 1306) includes, for example, a headphone jack 1318, data input 1320, wireless receiver 1322, or network connection 1324. In various aspects neural activity signal input 1304 includes circuitry for receiving a signal from a body area network, a local area network, or a wide area network.
Neural stimulus control signal determination circuitry 1308 includes one or more of amplitude (e.g., intensity), determination circuitry 1326 for determining a neural stimulus amplitude, frequency (e.g., pulse rate), determination circuitry 1328 for determining a neural stimulus frequency, waveform determination circuitry 1330 for determining a neural stimulus waveform, pattern determination circuitry 1332 for determining a neural stimulation pattern, or duration determination circuitry 1333 for determining a neural stimulus duration (e.g., circuitry configured to determine a duration that the neural stimulus is to be applied and/or a duration between neural stimulus applications). The neural stimulus control signal determination circuitry 1308 can also include a pulse duration determination circuitry (not shown) for determining a pulse duration of the neural stimulus, a burst determination circuitry (not shown) for determining a neural stimulus burst, a cycle determination circuitry (not shown) for determining a neural stimulus cycle, a modulation determination circuitry (not shown) to determining random neural stimulus, or any other suitable determination circuitry. In some embodiments, neural stimulus control signal determination circuitry 1308 is configured to control multiple stimulator channels (e.g., to provide alternating or simultaneous stimulation via two or more electrodes or electrode pairs, to steer electrical fields by controlling relative amplitude and/or polarity of stimuli on two or more electrodes, to control two or more different types of stimulators separately, or to control multiple stimulators in an array of stimulators). In an aspect, computing device 1302 includes data storage circuitry 1334 for storing data on the data storage device, including memory 1336 and circuitry for accessing data stored therein. Memory 1336 may contain stored preprogrammed stimulation patterns and waveforms as well as neural stimulus parameter values from which neural stimuli can be computed. In an aspect, system 1300 includes data storage circuitry 1334 for storing data on computing device 1302 representing neural stimulus control signal 1338. In an aspect, system 1300 includes data storage circuitry 1334 for storing data on computing device 1302 representing previous neural activity 1340. In an aspect, neural activity prediction circuitry 1342 predicts a future neural activity signal based on a previous neural activity signal.
In an aspect, system 1300 includes secondary stimulus determination circuitry 1344 for determining a secondary stimulus based on neural activity signal 1306. In an aspect, secondary stimulus determination circuitry 1344 determines the secondary stimulus control signal 1346 based on previous neural activity 1340.
In an aspect, system 1300 includes reporting circuitry 1348 for providing a report 1350 to at least one recipient. Reporting circuitry 1348 may cause report 1350 to be provided via a user interface 1214 (as described in connection with
In an aspect, system 1300 includes secondary signal input 1360 for receiving a secondary input signal 1354 at computing device 1302. In an aspect, neural stimulus control signal determination circuitry is configured to determine neural stimulus control signal 1310 based at least in part on secondary input signal 1354. Secondary input signal may be representative of a physiological parameter of the subject or an environmental parameter of the subject, and may include a signal sensed from a sensor on or associate with neural stimulation device 1314, or a sensor in the environment of the subject, and/or parameters or values derived from such sensed signals. In an aspect, the secondary input signal is indicative of a user input provided by the subject. In an aspect, secondary input signal 1354 may be received via user input device 1362 in user interface 1214.
In an aspect, system 1300 includes circuitry for presenting a recommendation to the subject. The recommendation may be presented to the subject via user output 1364 of user interface 1214, e.g., via audio output 1366 and/or graphical display 1368 or transmitted to neural stimulation system 1303 and presented via a user interface on neural stimulation system 1303. In an aspect, system 1300 includes recommendation receiving circuitry 1370 for receiving recommendation 1372 at computing device 1302. For example, in an aspect recommendation receiving circuitry 1370 receives recommendation 1372 via a computing network. In various aspects, recommendation 1372 is received from a medical care provider, from an insurance company, a service provider, an advisor, a computation-based system (including, e.g. an artificial intelligence), or a social media source, for example. In various aspects, recommendation receiving circuitry 1370 is configured to receive recommendations from particular sources, e.g. by receiving along with the recommendation a code indicating the source of the recommendation (e.g., a specific medical care provider, a medical care provider as opposed to a social media source), and to recognize a source of the recommendation and respond differently depending upon the source of the recommendation. Recommendation receiving circuitry 1370 may be configured such that recommendations from more credible sources may presented to the subject more promptly or more prominently, whereas recommendations from undesirable sources may be blocked, for example. Recommendation 1372 may relate to a configuration of neural stimulus control signal 1319 or secondary stimulus control signal 1346. In other aspects, recommendation 1372 relates to one or more of a consumer product, a service, a user experience, a user activity, or an organization that may be of interest to the subject, e.g., because the recommendations would enhance or be compatible with the effects of the neural stimulation received by the subject, or in some other manner relate to the neural stimulation or the condition which it is intended to treat. For example, the recommendation might be for software for storing, presenting, sharing, or reporting stimulation data or health data or for an organization that provides counseling to individuals with a particular condition. In an aspect, user input 1362 is configured to receive acceptance/rejection signal 1374 from the subject regarding acceptance or rejection of recommendation 1372.
In an aspect, system 1300 includes patch or update receiving circuitry 1376 for receiving patch/update 1378 at computing device 1302. Patch/update 1378 includes a software patch or update for software residing on computing device 1302 or neural stimulation device 1314 and may be received, for example, from the manufacturer of neural stimulation device 1314, from a service provider, or the like. In an aspect, computing device 1302 includes update circuitry 1380 for applying the patch or update to software installed on computing device 1302 or to software installed on neural stimulation device 1314, by sending update signal 1382 to neural stimulation system 1303. In an aspect, update circuitry 1380 also provides for updating a configuration of at least one of the neural stimulation device and the computing device, the configuration relating to operation of the neural stimulation device. In an aspect, update circuitry 1380 can be configured to update the configuration of at least one of the neural stimulation device and the computing device based on historical data (e.g., as stored in memory 1336). In another aspect, update circuitry 1380 is configured to update the configuration based on at least one instruction 1384. In an aspect, instruction 1384 is received via user input 1362 of computing device 1302. In another aspect, instruction 1384 is received from a computing network, (e.g., from a remote device or system, via a data input such as I/O 892 depicted in
In another aspect, update circuitry 1380 is configured to update the configuration of at least one of the neural stimulation device and the computing device based on at least one recommendation 1372. As discussed herein above, recommendation 1372 is received by recommendation receiving circuitry 1370, and can be received from an advisor, from a computation-based system (e.g., an artificial intelligence, machine learning system, or search engine based on a data-driven technique), or from a social media source (for example, in various aspects, the recommendation is based on the at least one preference of at least one social media contact, peer, or role model of the subject). In addition, acceptance/rejection input 1374 is received from the subject by user interface 1214 regarding acceptance or rejection of the recommendation, and update circuitry 1380 updates the configuration responsive to acceptance of the recommendation by the subject (if the recommendation is rejected, no update is made in response to the recommendation). As an alternative, acceptance or rejection of the recommendation can be provided by a caregiver of the subject regarding received via either user interface 1214 or via a data input from a remote device or system. Update circuitry 1380 updates the configuration responsive to acceptance of the recommendation by the caregiver of the subject. In another aspect, update circuitry 1380 is configured to update the configuration of at least one of the neural stimulation device and the computing device based on an environmental parameter (based in a secondary input signal 1354 received at secondary signal input 1360. In another aspect, update circuitry 1380 is configured to update the configuration of at least one of the neural stimulation device and the computing device automatically. For example, in an aspect, the configuration is updated automatically according to a schedule, for example when the time and/or date indicated by clock/timer 1386 matches an update time/date in schedule 1388 stored in memory 1336.
In an aspect, neural activity signal input 1304 includes circuitry for receiving neural activity signal 1306 via a secure connection. In an aspect, neural control signal output 1312 includes circuitry for outputting neural stimulus control signal 1346 via a secure connection. The secure connection may include be provided through the use of an encrypted signal, for example.
In an aspect, system 1300 includes output circuitry 1390 for presenting information to the subject via user interface 1214, including e.g., audio output 1366, graphical display 1368, alphanumeric display 1392, touchscreen 1394, or other user interface devices, as known to those of ordinary skill in the art.
In an aspect, system 1300 includes customization circuitry 1396. Customization circuitry 1396 customizes for the subject one or both of the information, or the formatting of the information, that is presented to via user interface 1214, based on user preferences, for example.
In an aspect, system 1300 includes authentication circuitry 1398 for receiving a credential 1400 showing that the subject is an authorized user. In an aspect, output circuitry 1390 presents information to the subject via user interface 1214 only following receipt of credential 1400 showing that the subject is an authorized user. In various aspects, authentication circuitry 1398 receives a password, a personal identification number, a biometric feature, or a card authentication, for example.
In an aspect, output circuitry 1390 includes output format circuitry 1402 for presenting the information to the subject via user interface 1214 in a graphical format that mimics the graphical format of an audio player, in a graphical format that mimics the graphical format of a mobile phone, or in any other graphical format that mimics the graphical format of a familiar user interface. This permits the subject to use the neural stimulation device discretely, and present to observers the impression that the computing device is functioning as a mobile phone or audio player rather than being used in connection with a neural stimulation device. In an aspect, output circuitry 1390 changes or discontinues the presenting of information to the subject via the user interface in response to an input signal 1404. For example, output circuitry 1390 switches between a first graphical format and a second graphical format on user interface 1214 in response to input signal 1404. For example, the first graphical format may present information relating to the neural stimulus, while the second graphical format may mimic the format of a mobile phone or audio player. In an aspect, input signal 1404 is a user input signal, received for example via user interface 1214. In another aspect, input signal 1404 is a sensed environmental signal indicative of presence of another person (e.g., an audio input signal containing the detected voice of the other person, received via secondary input signal 1354). In an aspect, input signal 1404 is indicative of a time (e.g., a signal received from clock/timer 1386 on computing device 1302).
In an aspect, neural stimulus control signal determination circuitry 1308 modulates neural stimulus control signal 1310 in response to an override signal. For example, in an aspect override signal is input signal 1404 received via user input 1362. In an aspect, override signal is secondary input signal 1354, received via secondary signal input 1360. In an aspect, the override signal originates from a sensor that senses a physiological parameter, such as heart rate. In the event that the physiological parameter indicates an unsafe condition (e.g., the heart rate is too high or too low), the neural stimulus control signal determination circuitry 1308 modulates neural stimulus control signal 1310 to discontinue production of the neural stimulus. For example, in various aspects, the override signal originates from a sensor responsive to sensing a presence of a person other than the subject in the vicinity of the subject or responsive to sensing that the external neural stimulator is not properly positioned on the pinna of the subject. In an aspect, neural stimulus control signal determination circuitry 1308 modulates neural stimulus control signal 1310 to discontinue production of the neural stimulus. In an aspect, neural stimulus control signal determination circuitry 1308 modulates neural stimulus control signal 1310 to change an intensity of the neural stimulus. In addition to modulating or discontinuing the neural stimulus in response to an override condition (e.g., physiological parameter indicative of an unsafe condition, improper positioning of the external neural stimulator, etc.), a notification may be sent to the subject and/or to a medical care provider or other party regarding the override condition, to prompt the recipient of the notification to take corrective action, or for inclusion of the information in the subject's medical records.
In an aspect, secondary signal input 1360 is adapted to receive a position signal indicative of a position of the external neural stimulator with respect to the pinna of the subject. In connection therewith, system 1300 may also include notification circuitry 1406 for delivering a notification to the subject indicating that the external neural stimulator should be repositioned. In an aspect, notification circuitry 1406 includes circuitry for delivering the notification via a graphical display 1368 of computing device 1302. In an aspect, notification circuitry 1406 includes circuitry for delivering an auditory alert, either via audio output 1366 of computing device, or by generating an appropriate audio output signal 1408 for driving production of the auditory alert by a sound source 1410 on neural stimulation device 1314. In an aspect, notification circuitry 1406 includes circuitry for delivering a voice message (e.g., a preset message retrieved from memory 1336). In a further aspect, notification circuitry 1406 includes circuitry for storing information indicating that stimulator 1316 is improperly positioned in a data storage location (e.g., memory 1336) in computing device 1302. In another aspect, notification circuitry 1406 provides for storing information indicating that stimulator 1316 is improperly positioned in a data storage location in neural stimulation device 1314 (e.g., by transmitting such information to neural stimulation device 1314.
In an aspect, system 1300 includes circuitry for outputting an audio output signal, either via an audio output 1366 of computing device 1302 or via sound source 1410 of neural stimulation device 1314, where the audio output signal drives delivery of sound to the ear of the subject via a sound source. In an aspect, output circuitry 1390 is used to output the audio output signal via audio output 1366 of the computing device. In an aspect, communication circuitry 1218 is used for transmitting audio output signal 1408 to a sound source 1410 on neural stimulation device 1314. Alternatively, communication circuitry 1218 can be used to deliver an audio output signal to sound source distinct from the neural stimulation device (e.g., a sound source included in a device used by the subject, but not included in the neural stimulation device). In an aspect, output circuitry 1390 retrieves an audio signal from a data storage location (e.g., memory 1336) on computing device 1302, and generate audio output signal based on the retrieved audio signal. In another aspect, system 1300 includes audio receiver 1412 for receiving audio input signal 1414 from a telecommunication network. For example, in various aspects, audio input signal 1414 is a broadcast radio signal, a webcast audio signal, or a mobile phone signal.
In an aspect, system 1300 includes prioritization circuitry 1416 for prioritizing delivery of the neural stimulus control signal relative to the audio output signal (either audio output signal 1408 for delivery to sound source 1410, and/or an audio output signal delivered via audio output 1366 on computing device 1302). In an aspect, prioritization circuitry 1416 automatically discontinues outputting of the neural stimulus control signal 1310 and starts outputting of the audio output signal in response to receipt of audio input signal 1414. In another aspect, prioritization circuitry 1416 automatically declines audio input signal 1414 if the neural stimulus is currently being delivered. In another aspect, prioritization circuitry 1416 provides for circuitry for outputting the audio output signal simultaneously with neural stimulus control signal 1310. In another aspect prioritization circuitry 1416 provides for switching between outputting the audio output signal and outputting neural stimulus control signal 1346. Switching may occur in response to a user input received via user input 1362, or in response to sensor input received, for example, via secondary signal input 1360. In an aspect, prioritization circuitry 1416 performs switching between outputting the audio output signal and outputting neural stimulus control signal 1310 according to a schedule (stored, e.g., in memory 1336) in response to input from clock/timer 1386. In an aspect, prioritization circuitry 1416 switches between outputting the audio output signal and outputting the neural stimulus control signal responsive to receipt of the audio input signal 1414 from a telecommunication network. Prioritization circuitry 1416 may be configured to give higher priority to outputting of the neural stimulus control signal than to outputting of the audio output signal, or to give higher priority to outputting of the audio output signal than to outputting of the neural stimulus control signal. The priority of the signals may be determined by the preference of the subject. For example, the subject may consider it a higher priority to receive a phone call via his or her mobile phone than to continue received of a neural stimulation, and therefore may configure system 1300 so that neural stimulation is discontinued when a phone call is received. Alternatively, the subject may prefer that a neural stimulation session not be interrupted, and may configure system 1300 such that no phone calls will be received while neural stimulation is taking place. In other aspects, the subject may provide an input at user interface 1214 (e.g., by pressing a button) to switch between receiving neural stimulation and listening to music, as preferred. In another aspect, system 1300 is configured to deliver neural stimulation in combination with music.
In an aspect, method 1450 includes receiving a secondary input signal at the computing device and determining the neural stimulus control signal based at least in part on the secondary input signal, as indicated at 1462. For example, in an aspect the secondary input signal is indicative of a user input provided spontaneously by subject. Other secondary input signals are described herein above.
In an aspect, method 1450 includes presenting a recommendation to the subject, as indicated at 1464. Method 1450 may also include receiving the recommendation at the computing device, as described above in connection with
In an aspect, method 1450 includes receiving a patch or update at the computing device, the patch or update relating to operation of the neural stimulation device, as indicated at 1466. In an aspect, the patch or update is for software installed on the computing device. In another aspect, the patch or update is for software installed on the neural stimulation device, in which case method 1450 may also include sending the patch or update to the neural stimulation device.
In an aspect, method 1450 includes updating a configuration of at least one of the neural stimulation device and the computing device, the configuration relating to operation of the neural stimulation device, as indicated at 1468. As discussed above, the configuration is updated based on at least one instruction. In another aspect, the configuration is updated based on at least one recommendation, responsive to receipt of an input regarding acceptance of the recommendation by the subject or a caregiver of the subject.
In an aspect, method 1450 includes presenting information to the subject via a user interface, as indicated at 1470. The method may also include changing or discontinuing the presenting of information to the subject via the user interface in response to an input signal. In an aspect, method 1450 includes modulating the neural stimulus control signal in response to an override signal, as indicated at 1472.
In an aspect, method 1450 includes receiving a position signal indicative of the position of the external neural stimulator with respect to the pinna of the subject, as indicated at 1474. Method 1450 may also include delivering a notification to the subject indicating that external neural stimulator should be repositioned. Other method aspects are discussed in connection with
In an aspect, system 1900 includes prioritization circuitry 1416 which prioritizes between delivery of neural stimulus and delivery of the audio output signal, based upon system settings and/or preferences of the subject. For example, prioritization circuitry 1416 provides for automatically discontinuing outputting of the neural stimulus control signal and starting outputting of the audio output signal in response to receipt of the audio input signal, automatically declining the audio input signal if the neural stimulus is currently being delivered, or outputting the audio output signal simultaneously with the neural stimulus control signal. In other aspects, prioritization circuitry 1416 provides switching between outputting the audio output signal and outputting the neural stimulus control signal, for example in response to a user input or a sensor input, according to a schedule, or in response to receipt of an audio input signal (e.g., a phone call) from a telecommunication network. Depending on preference of the subject or other considerations, prioritization circuitry 1416 can be configured to give higher priority to outputting of the neural stimulus control signal than to outputting of the audio output signal, or to give higher priority to outputting of the audio output signal than to outputting of the neural stimulus control signal.
In some aspects, wearable neural stimulation devices and systems as described herein above are used in combination with remote systems. For example,
In various aspects, neural stimulation device 2510 is a neural stimulation device of any of the various types described herein, e.g., in connection with any of
Secondary stimulator 2526, sensor 2528, and computing device 2534 are as described herein above, e.g., in connection with at least
Computing system 2502 includes one or more computing device, as described generally in connection with
In various aspects, identifying information 2506 includes device information 2602 pertaining to the neural stimulation device 2510, or subject information 2610 pertaining to the subject. Device information 2602 includes, for example, device type information 2604, device serial number 2606, or device inventory number 2608). Subject information 2610 includes, for example, a name of the subject 2612, a user name 2614 associated with the subject, an email address 2616 associated with the subject, a subject identification 2618 (e.g., identification number, code or the like), or biometric information 2620 associated with the subject. In various aspects, subject identification 2618 can be input by the subject via a user input, read with a bar-code or RFID reader, received with an RF receiver, etc.
Recommendation 2522 may include one or more recommendations for various aspects of device and system configuration for delivery of neural stimulation, and for one or more additional stimuli or experiences to be presented to or experienced by the subject in association with the neural stimulus. In various aspects, recommendation 2522 is for a configuration of the neural stimulus 2622 (e.g., stimulus amplitude 2624, frequency 2626, duration 2628, waveform 2630, or delivery pattern 2632). In various aspects, recommendation 2522 is for a secondary stimulus 2632 to be delivered in association with the neural stimulus. In various aspects, secondary stimulus 2632 includes music, an auditory stimulus, a video stimulus, a tactile stimulus, a haptic stimulus, an olfactory stimulus, a pharmaceutical, a nutraceutical, a secondary neural stimulus, an experience (including, but not limited to a virtual reality experience, a game experience, a virtual therapist experience, an augmented reality experience, and/or an interactive experience). In various aspects, recommendation 2522 is for a product 2634, a service 2636, an activity 2638, an experience 2640, or an organization 2642. The recommendation may be for multiple experiences. In an aspect, the recommendation specifies a stimulation pattern of delivery of the experience(s). It will be appreciated that not all secondary stimuli recommended for use in conjunction with a neural stimulus are delivered by the neural stimulation system. Recommendations (e.g., for a product, service, experience, or organization) can be presented to the subject via the computing device in the form of a link to a relevant website, so that the subject may conveniently access the recommended product, service, experience, or organization, which the subject does, as desired.
Treatment regimen information 2574 includes, for example, neural stimulus information 2650 regarding the neural stimulus, secondary stimulus information 2652 regarding a secondary stimulus delivered in association with the neural stimulus, information 2654 regarding a secondary data signal, which may specifically include neural sensor signal information 2656, physiological sensor signal information 2658, environmental sensor signal information 2660, motion sensor information 2662 or location sensor information 2664.
In an aspect, receiving the identifying information at the computing system includes receiving information transmitted from the computing device. In an aspect, receiving the identifying information at the computing system includes receiving information transmitted via a computing network. In an aspect, receiving the identifying information at the computing system includes receiving information transmitted via a wireless network. In an aspect, providing the recommendation relating to the treatment regimen to the subject includes transmitting the recommendation to a computing device, e.g., via a computing network or a wireless network.
In an aspect, the recommendation is received at the computing system from a medical care provider. In another aspect, the recommendation is generated at the computing system, e.g., by recommendation circuitry 2520 as shown in
In an aspect, method 2700 includes receiving information regarding whether the subject has accepted or rejected the recommendation. In an aspect, method 2700 includes receiving a credential showing that the subject is an authorized user of the computing device. For example, the credential may include a password, a PIN, a biometric feature, or a card authentication, and/or a credential showing that the computing device is an authorized device.
In an aspect, method 2700 includes storing at least one parameter of the neural stimulus in a data storage location associated with the computing system (e.g., with data storage circuitry 2566 of computing system 2502).
In aspect, the recommendation relates to at least one parameter of the neural stimulus, for example, an amplitude, frequency, waveform, or duration of delivery of the neural stimulus, or stimulation pattern for delivery of the neural stimulus. The stimulation pattern may be, for example, a preprogrammed stimulation pattern, a continuous stimulation pattern, an intermittent stimulation pattern, a time-varying stimulation pattern, and/or a pulsed stimulation pattern. In an aspect, the recommendation specifies a selection of one of multiple stimulation patterns.
In an aspect, receiving the identifying information at the computing system includes receiving information transmitted from the computing device.
In an aspect, method 2700 includes transmitting a report relating to the treatment regimen to at least one recipient. In an aspect, the at least one recipient includes, for example, the subject, a caregiver of the subject, at least one social media contact of the subject, at least one peer of the subject, at least one medical care provider, or at least one insurance provider. In an aspect, the recipient is a computing system, e.g. a computing system used for storing and/or processing healthcare information. In some cases the report is anonymized, e.g., to preserve the privacy of the subject. The report may include demographic information pertaining to the subject, but not personal identifying information pertaining to the subject, for example. In an aspect, transmitting the report includes transmitting the report to the computing device. The report may include, for example, a neural stimulus control signal, a determined compliance of the subject with the treatment regimen, a determined efficacy of the treatment regimen, one or more system settings for controlling delivery of the neural stimulus, data retrieved from a data storage location associated with the computing system, and/or information regarding a secondary stimulus delivered in association with the neural stimulus. Compliance of the subject and/or efficacy of the treatment regimen may be determined by questioning the subject directly, by questioning another party, such as a caregiver, or by making a determination from measured physiological parameters of the subject.
In an aspect, method 2700 includes receiving a report relating to the treatment regimen from the computing device. In an aspect, method 2700 includes storing information relating to the treatment regimen in a data storage location associated with the computing system, e.g., treatment regimen information 2574 as described in connection with
In an aspect, method 2700 includes receiving information at the computing system regarding a previously delivered treatment regimen. In addition, the method may include receiving information at the computing system regarding a response of subject to the previously delivered treatment regimen.
In an aspect, method 2700 includes sending a patch or update to a computing device from the computing system. The patch or update may be for software installed on the computing device, or for software installed on the external neural stimulator.
In an aspect, method 2700 includes generating an update for the configuration of the neural stimulus. This may be done based on a response of the subject to a previous treatment regimen, based on an environmental factor, or based on motion or location of the subject. In an aspect, the update is generated automatically e.g., when it is determined that an update is needed (based on a subject response or sensed environmental factor). In another aspect, the update is generated based upon acceptance of a recommendation for the update by the subject.
Neural stimulus control signal determination circuitry 2914 is used to generate neural stimulus control signal 2920, which drives delivery of a neural stimulus via electrodes 414a and 414b. Secondary stimulus determination circuitry 2916 is used to generate secondary stimulus control signal 2922, which controls delivery of the therapeutic secondary stimulus while subject 2904 is receiving stimulation delivered to pinna 2902. In the example of
Heart rate 2932, sensed with a heart rate sensor (for example an ECG sensor or pulse oximeter sensor) in ear canal insert 416, is provided to physiological activity input circuitry 2910. The subject's heart rate is monitored during delivery of neural stimulation in combination with the therapeutic secondary stimulus, to track the effect of the stimulation and therapy over time. Amount of heart rate variability and duration of heart variability and/or changes in heart rate variability over time may be monitored. Heart rate variability is an indicator of the balance between sympathetic and parasympathetic tone. Increased heart rate variability is associated with reduced inflammation and anxiety. In addition, the physiologic data can be coupled with how the subject interacts with the program. In an aspect, one or both of neural stimulus control signal 2920 and secondary stimulus control signal 2922 are modified (by neural stimulus control signal determination circuitry 2914 and secondary stimulus determination circuitry 2916, respectively), in response to heart rate 2932 and user input 2930. Physiological data regarding the subject's heart rate as well as data regarding interaction of subject 2904 with application software 2908 can be included in report 2934 which can be sent to the subject's medical care provider or psychologist via network 2936. Detection of a heart rate indicative of an unsafe condition due to the neural stimulation results in discontinuation or modulation of stimulation, and transmittal of a notification to the subject's medical care provider.
The ear canal insert 3005 may be adapted to fit into an ear canal of a human subject. The ear canal insert 3005 can include a first electrode 3030 to electrically contact skin within the ear canal of the subject. The first electrical connector 3040 may connect the electrode 3030 of the ear canal insert to a first electrical current source. The concha insert 3010 may be adapted to fit within a concha of the subject. The concha insert 3010 may include a base portion 3015 configured to fit within the cavum of the concha of the subject and a wing portion 3020 configured to fit within the cymba of the concha of the subject. In some embodiments, the concha insert 3010 may include at least one second electrode 3035 to electrically contact at least a portion of the concha of the subject. Although the second electrode 3035 is shown on the wing portion 3020 in the aspect depicted in
In an embodiment, not shown, the nerve stimulation earpiece 3000 can include one or more extensions that are the same as or can be similar to any of the extensions disclosed herein. The extensions can include one or more electrodes disposed thereon or therein. The extensions can extend from the nerve stimulation earpiece 300 such that the electrodes of the extensions contact a portion of the posterior surface of the pinna that corresponds to at least one of the first electrode 3030 or the second or 3035.
In some embodiments, the nerve stimulation earpiece 3000 may include or otherwise be formed a disposable material. For example, the electrode 3030 or electrode 3035 may be disposable electrodes. In another example, a portion of or the entire ear canal insert 3005 and/or concha insert 3010 may be disposable. In some embodiments, the wing portion 3020 of the concha insert 3010 may include a soft, deformable, compliant, flexible, and/or resilient material. In some embodiments, the wing portion of 3020 the concha insert 3010 may include a rigid material. In some embodiments, the concha insert 3010 may include both a rigid material and a soft, deformable, compliant, flexible, and/or resilient material. In some embodiments, the base portion of the concha insert 3010 may include a hard material. In some embodiments, the base portion and the wing portion 3020 of the concha insert may be integrally formed with each other. In some embodiments, one or more components of the nerve stimulation earpiece 3000 may be constructed by a three-dimensional (3D) printer.
In some embodiments, at least a portion of the nerve stimulation earpiece 3000 (e.g., concha insert 3010 and/or ear canal insert 3005) may be formed for a specific subject, which can optimize the fit, thereby making the nerve stimulation earpiece 3000 more comfortable to wear and/or aiding in optimizing performance. For example, at least a portion of the nerve stimulation earpiece 3000 may be custom made for a specific subject. In some embodiments, the nerve stimulation earpiece 3000 may include a material that may be initially compliant to mold to a subject's ear and then subsequently retains its shape. For example, the material may be a plastic that is softened by heat, placed in a subject's concha and/or ear canal to mold to the subject's ear, then, once cooled, the plastic may retain its molded shape. In another example, the material may be an air-activated material that is initially compliant and hardens after exposure to air. In some embodiments, an impression of a subject's ear may be taken and a mold formed from the impression. The mold may be used to form the nerve stimulation earpiece 3000. In some embodiments, a 3D scan may be taken of the subject's ear and a mold may be generated from the 3D scan for forming the nerve stimulation earpiece 3000. In another embodiment, the nerve stimulation earpiece 3000 may be constructed directly from the 3D scan (e.g., 3D printer, milling machine).
In some embodiments, the first electrode 3030 may have an electrical contact area between about 190 mm2 and about 380 mm2. In some embodiments, the second electrode 3035 may have an electrical contact area between about 100 mm2 and about 220 mm2. All or a portion of the electrical contact area of the first electrode 3030 and/or second electrode 3035 may contact the skin of a subject. In some embodiments, the first electrode 3030 and/or second electrode 3035 may include a silver/silver chloride, platinum, tungsten, stainless steel, and/or gold component, conductive gel, hydrogel, conductive polymer, conductive foam, and/or fabric. In some embodiments, the first electrode 3030 and/or second electrode 3035 may include a layered structure including a hydrogel layer and a conductive polymer layer. In the example depicted in
In some embodiments, the nerve stimulation earpiece 3000 may include wireless communication circuitry 3120. The wireless communication circuitry 3120 may be adapted to receive an audio signal. The wireless communication circuitry 3120 may transmit or receive a data signal. The audio signal and/or data signal may be transmitted and/or received from an audio device (e.g., CD player, mp3 player) and/or a computing device (e.g., tablet computer, mobile phone, smart watch, laptop). The wireless communication circuitry 3120 may include Bluetooth® communication circuitry in some embodiments.
In some embodiments, the nerve stimulation earpiece 3000 may include a physiological sensor 3125. In some embodiments, the physiological sensor 3125 may be a separate device operably coupled to the nerve stimulation earpiece 3000. The physiological sensor 3125 may receive and/or transmit a signal indicative of a physiological status of the subject. In some embodiments, a nerve stimulus provided by the nerve stimulation earpiece 3000 may be based, at least in part, on the signal received and/or transmitted by the physiological sensor 3125. The physiological sensor 3125 may include at least one of an electroencephalogram (EEG) sensor, a heart rate sensor, a moisture sensor, a temperature sensor, a bio sensor, a chemical sensor, electrocardiograph (ECG), motion sensor (e.g., accelerometer and/or gyroscope), electromyogram (EMG), pulse oximeter, galvanic response sensor, or a photoplethysmograph probe. Other physiological sensors may also be used to implement the physiological sensor 3125. In some embodiments, the nerve stimulation earpiece 3000 may include multiple physiological sensors 3125. In some embodiments, when the physiological sensor 3125 is implemented with a photoplethysmograph probe, the photoplethysmograph probe may include a 660 nm red wavelength LED 3130 and a 940 nm infrared wavelength LED 3135.
In some embodiments, the never stimulation earpiece includes an integral audio headphone for delivery of audio signals to a subject. In some embodiments, the nerve stimulation earpiece may include at least one mounting structure to physically mount the concha insert and/or the ear canal insert to a body structure of an audio headphone. The audio headphone may be a commercially available audio headphone (e.g., Bose® SoundSport®, Adidas® Monster® Sport, Jaybird X2) and the mounting structure of the nerve stimulation earpiece may be configured to mate with the commercially available audio headphone. In some embodiments, the audio headphone may be adapted to mate with the mounting structure of the nerve stimulation earpiece.
In some embodiments, the nerve stimulation earpiece 3200 may include a wired connection 3255. The audio headphone 3250 may include a wired connection 3260 in some embodiments. The wired connection 3255 and the wired connection 3260 may be held together by one or more clips 3265. The clips may prevent or reduce tangling of the wired connections 3255, 3260. In some embodiments, the nerve stimulation earpiece 3200 and/or audio headphone 3250 may include wireless connections. In such embodiments, the nerve stimulation earpiece 3200 and/or the audio headphones 3250 can include a power source.
In some embodiments, the throughhole 3525 has a non-circular shape and at least a portion 3540 of the projection 3530 has a non-circular shape complementary to the shape of the throughhole 3525. When the projection 3530 is fit into the throughhole 3525, the concha insert 3510 may be prevented from rotating with respect to the body structure of the audio headphone 3550. In some embodiments, the concha insert 3510 and the body structure of the audio headphone 3550 may have other or additional complementary mating features that may prevent rotation of the concha insert 3510 with respect to the body structure of the audio headphone 3550.
In some embodiments, the concha insert 3510 has a first face 3511 to face toward the concha of the subject and a second face 3512 to face away from the concha of the subject and toward the body structure of the audio headphone 3550. In some embodiments, the base portion 3515 of the concha insert 3510 and the ear canal insert 3505 may include complementary mating features 3545, 3555 that may permit assembly of the concha insert 3510 with the body structure of the audio headphone 3550 with the second face 3512 facing toward the body structure of the audio headphone 3550 and may prevent assembly of the concha insert 3510 to the body of the audio headphone with the first face 3511 facing toward the body structure of the audio headphone 3550. In some embodiments, the base portion 3515 of the concha insert 3510 and the body structure of the audio headphone 3550 may include complementary mating features that may permit assembly of the concha insert 3510 with the body structure of the audio headphone with the second face 3512 facing toward the body structure of the audio headphone 3550 and may prevent assembly of the concha insert 3510 to the body of the audio headphone 3550 with the first face 3511 facing toward the body structure of the audio headphone 3550. In some embodiments, the portion 3540 of the projection 3530 and the complementary mating feature 3545 may be complementary features.
Although
The wireless microcontroller 4030 may control wireless communication between the ear stimulation device controller 4000 and a computing device 4045 to receive one or more stimulation parameters from the computing device 4045. Example computing devices include, but are not limited to, a smart phone, a mobile phone, a tablet computer, and an mp3 player. The digital stimulus signal generator 4020 may generate a digital stimulus signal based, at least in part, on the one or more stimulation parameters received from the computing device 4045. The DAC 4025 may convert the digital stimulus signal from the digital stimulus signal generator 4020 to an analog voltage waveform. The current driver 4015 may be operably connected to the DAC 4025 and generate a controlled current stimulus waveform responsive to the analog voltage waveform. The controlled current stimulus waveform may be provided to the ear stimulation device 4040 via the first analog output connector 4005 and the second analog output connector 4010. The power source 4035 may be operably connected to the wireless microcontroller 4030, digital stimulus signal generator 4020, the DAC 4025, and/or the current driver 4015.
In some embodiments, the wireless microcontroller 4030 may be a CC2650 microcontroller. An example of a wireless microcontroller that may be used to implement the wireless microcontroller 4030 is Texas Instruments CC2650 SimpleLink multi-standard ultra-low power wireless microcontroller unit for Bluetooth® communication. The wireless microcontroller 4030 may be compatible with a JTAG standard debugging interface in some embodiments. The wireless microcontroller 4030 may include a plurality of general purpose input/output pins in some embodiments. The wireless microcontroller 4030 may include a configurable serial peripheral interface in some embodiments. The wireless microcontroller 4030 may be a Bluetooth® controller in some embodiments.
The DAC 4025 may include two or more output channels in some embodiments. One or more of the output channels may produce an inverted signal relative to another of the output channels. The DAC 4025 may be an 8-bit, 10-bit, 12-bit, 14-bit, or 16-bit DAC. Other bit value converters may also be used to implement the DAC 4025. The DAC 4025 may be implemented as a single-channel or a multi-channel DAC. In some embodiments, the DAC 4025 may be implemented with a DAC7760. An example of a DAC that may be used to implement the DAC 4025 is Texas Instruments DAC7760 12-bit, single-channel, programmable current/voltage output DAC. Another example of a DAC that may be used to implement DAC 4025 is Texas Instruments Dual, Low Power, Ultra-low Glitch, Buffered Voltage Output DAC8163.
In some embodiments, the ear stimulation device controller 4000 may include a signal inverter 4021 to invert the analog voltage waveform output by the DAC 4025. The inverted signal may be provided by the signal inverter 4021 to the current driver 4015. In some embodiments, the ear stimulation device controller 4000 may include a signal inverter 4021 to invert the analog current wave form output by the current driver 4015. The signal inverter 4021 may provide the inverted signal to the first analog output connector 4005 and the second analog output connector 4010.
In some embodiments, the current driver 4015 may generate a controlled current output unaffected by load impedance. In some embodiments, the current driver 4015 may be implemented as an XTR300 analog current/voltage output driver. An example of a current driver that may be used to implement the current driver 4015 is Texas Instruments XTR300 Industrial Analog Current/Voltage Output Driver. The current driver 4015 may provide biphasic current stimulation in some embodiments. In some embodiments, the current driver 4015 may provide a current output between −100 mA and 100 mA. In some embodiments, the current driver 4015 may provide a current output between −20 mA and +20 mA. In some embodiments, the current output may be at a maximum voltage of +/−40V. In some embodiments, the current output may be at a maximum voltage of +/−10V. In some embodiments, the current driver 4015 may receive a power input of +/−15V. In some embodiments, the current driver 4015 may receive an input signal voltage of +/− VDD-3 and an external reference voltage. The current driver 4015 may supply over temperature, overcurrent, and common-mode over-range error signals in some embodiments.
In some embodiments, the current driver 4015 may include an internal instrumentation amplifier 4016 to supply a copy of the stimulating current through a set resistor via an IA channel. In some embodiments, the current driver 4015 may include an internal operational amplifier 4017 configured to supply a 1/10th current copy. In some embodiments, the current driver 4015 may provide current to two or more stimulus channels that are electrically isolated from each other.
In some embodiments, the current driver 4015 may generate current pulses that fall within safety ranges and/or comply with safety regulations (e.g., FDA regulations). The current driver 4015 may generate current pulses of no more than 200 Hz, 500 Hz, 1 kHz, or another maximum frequency. The current driver 4015 may generate current pulses having a pulse duration of no more than 2 ms in some embodiments. The current driver 4015 may generate current pulses having a voltage of no more than +/−12V. In some embodiments, the current driver 4015 may generate current pulses having a voltage compliance of no more than +/−10V. In some embodiments, the current driver 4015 may generate current pulses with a maximum average current of no more than 10 mA. The current driver 4015 may generate current pulses with a maximum primary depolarizing phase duration of no more than 500 ms in some embodiments. The current driver 4015 may generate current pulses with a maximum direct current of no more than 100 mA during a non-pulse or device failure in some embodiments.
In some embodiments, the power source 4035 includes a battery 4036. The battery 4036 may be implemented as a 3.7V Li-Polymer battery. The ear stimulation device controller 4000 may include a microUSB port 4037 connected to the battery 4036. The microUSB port 4037 may be configured to connect the battery 4036 to an external power source 4050 for recharging. The power source 4035 may supply 3.3V in some embodiments. The power source 4035 may include a battery protection integrated circuit 4038 in some embodiments. An example of a battery protection integrated circuit that may be used to implement the battery protection integrated circuit 4038 is the Texas Instruments BQ2970 voltage and current protection integrated circuit. Another example of a battery protection integrated circuit that may be used to implement the battery protection integrated circuit 4038 is the Microchip MCP7383X Li-Ion System Power Path Management Reference. The power source 4035 may provide voltage and current protection in the event of erratic behavior, overcharging, or energy depletion in the battery. The power source 4035 may automatically shut off current flow upon detection of an overcharge, over-discharge, or a short circuit. The power source 4035 may resume operation when an internal timer expires. In some embodiments, the ear stimulation device controller may include an internal timer 4039.
In some embodiments, the power source may include a connector 4041. In some embodiments, the connector 4041 is a microUSB connector configured to connect to a power output of a mobile phone via a microUSB port. In some embodiments, the connector 4041 is an audio jack connector configured to connect a power output of a mobile phone via a phone audio jack. In some embodiments, the power output of the mobile phone is provided by a battery included in the mobile phone.
In some embodiments, the computing device 4045 may be a mobile phone. The mobile phone may include a microUSB connection, an audio jack, and/or wireless connections. In some embodiments, the wireless microcontroller 4030 may communicate one or more data signals between the ear stimulation device controller 4000 and a mobile phone via a microUSB connection. In some embodiments, the wireless microcontroller 4030 may communicate one or more data signals between the ear stimulation device controller 4000 and a mobile phone via a 2.4 GHz Bluetooth® connection. The wireless microcontroller 4030 may communicate one or more data signals between the ear stimulation device controller 4000 and the mobile phone via an audio jack of the phone. The wireless microcontroller 4030 may communicate one or more data signals between the ear stimulation device controller 4000 and the mobile phone via a wireless connection.
In some embodiments, the ear stimulation device controller 4000 may include a case 4046 that includes a recess 4047 to receive a computing device. The recess may be configured to receive a mobile phone or a tablet computer. The ear stimulation device controller 4000 may include an attachment means other than the recess 4047 for attaching the case 4046 to the computing device in some embodiments. In some embodiments, the case 4046 may be a cell phone case that includes recess 4047 to receive a cell phone. The ear stimulation device controller 4000 may include a microUSB connector 4048 to mate with a microUSB port of the cell phone.
In some embodiments, the ear stimulation device controller 4000 may include a physiological signal input 4049 that may receive a physiological signal. The physiological signal input 4049 may receive a signal indicative of a physiological status of the user. In some embodiments, the output of the digital stimulus signal generator 4020 and/or current driver 4015 may be based, at least in part, on the signal received by the physiological signal input 4049. The first and second output connectors 4005, 4010 may be connected to the ear stimulation device 4040 located on a first ear of the user and the physiological signal input may receive the physiological signal from a physiological sensor 4060 located on a second ear of the user.
The ear canal insert 4205 may be adapted to fit into an ear canal of a human subject. The ear canal insert 4205 may include a first electrode 4230 to electrically contact skin within the ear canal of the subject. The first electrical connector 4240 may connect the electrode 4230 of the ear canal insert 4205 to a first analog output connector 4255 of an ear stimulation device controller 4202. The concha insert 4210 may be adapted to fit within a concha of the subject. The concha insert 4210 may include a base portion configured to fit within the cavum of the concha of the subject and a wing portion configured to fit within the cymba of the concha of the subject. In some embodiments, the concha insert 4210 may include a second electrode 4235 to electrically contact at least a portion of the concha of the subject. The second electrical connector 4225 may connect the electrode 4235 of the concha insert to a second analog output connector 4260 of the ear stimulation device controller 4202.
In some embodiments, the nerve stimulation earpiece 4201 may include wireless communication circuitry 4220. The wireless communication circuitry 4220 may be adapted to receive an audio signal. The wireless communication circuitry 4220 may transmit or receive a data signal. The audio signal and/or data signal may be transmitted and/or received from an audio device (e.g., CD player, mp3 player), a computing device 4290 (e.g., tablet computer, mobile phone, smart watch, laptop), and/or the ear stimulation device controller 4202.
In some embodiments, the nerve stimulation earpiece 4201 may include a physiological sensor 4245. In some embodiments, the physiological sensor 4245 may be a separate device operably coupled to the nerve stimulation earpiece 4201. The physiological sensor 4245 may transmit and/or receive a signal indicative of a physiological status of a subject. The physiological sensor 4245 may include at least one of an electroencephalogram (EEG) sensor, a heart rate sensor, a moisture sensor, a temperature sensor, a bio sensor, a chemical sensor, electrocardiograph (ECG), motion sensor (e.g., accelerometer and/or gyroscope), electromyogram (EMG), pulse oximeter, galvanic response sensor, or a photoplethysmograph probe. Other physiological sensors may also be used to implement the physiological sensor 4245. In some embodiments, the nerve stimulation earpiece 4201 may include multiple physiological sensors 4245. The physiological sensor may be coupled to a physiological signal input 4295 of the ear stimulation device controller 4202 in some embodiments. The physiological signal input 4295 may receive the signal from the physiological sensor 4245. In some embodiments, an output of a digital stimulus signal generator 4275 and/or current driver 4265 of the ear stimulation device controller 4202 may be based, at least in part, on the signal received by the physiological signal input 4295 from the physiological sensor 4245.
The ear stimulation device controller 4202 may include a first analog output connector 4255, a second analog output connector 4260, a wireless microcontroller 4280, a digital stimulus signal generator 4275, a digital-to-analog converter (DAC) 4270, a current driver 4265, and a power source 4285. The first analog output connector 4255 may connect a first current signal to the first electrode 4230 of nerve stimulation earpiece 4201 via first electrical connector 4240. The second analog output connector 4260 may connect a second current signal to the second electrode 4235 of nerve stimulation earpiece 4201 via second electrical connector 4225.
The wireless microcontroller 4280 may control wireless communication between the ear stimulation device controller 4202 and the computing device 4290 to receive one or more stimulation parameters from the computing device 4290. Example computing devices include, but are not limited to, a smart phone, a mobile phone, a tablet computer, and an mp3 player. The digital stimulus signal generator 4275 may generate a digital stimulus signal based, at least in part, on the one or more stimulation parameters received from the computing device 4290. The DAC 4270 may convert the digital stimulus signal from the digital stimulus signal generator 4275 to an analog voltage waveform. The current driver 4265 may be operably connected to the DAC 4270 and generate a controlled current stimulus waveform responsive to the analog voltage waveform. The controlled current stimulus waveform may be provided to the nerve stimulation earpiece 4201 via the first analog output connector 4255 and the second analog output connector 4260. The power source 4285 may be operably connected to the wireless microcontroller 4280, digital stimulus signal generator 4275, the DAC 4270, and/or the current driver 4265.
In some embodiments, the nerve stimulation earpiece 4201 may be implemented with nerve stimulation earpiece 3000. In some embodiments, the ear stimulation device controller 4202 may be implemented with ear stimulation device controller 4000.
Determining a parameter indicative of a position of the earpiece with respect to the ear of the user can include, for example, determining a distance of one or more portion of the earpiece with respect to various anatomical features of the ear, e.g., the ear canal, the tragus, the helix, the lobe, etc., to determine whether the earpiece is positioned on the appropriate portion of the pinna or inserted far enough into the ear canal, for example. In an aspect, method 4400 further includes delivering, under control of notification circuitry on the computing device, a notification to the user informing the user of the need to adjust a position of an earpiece of the ear stimulation device with respect to the ear of the user, as indicated at 4418. In various aspects, delivering a notification includes delivering a text notification 4420, delivering a visible notification 4422, or delivering an audio notification 4424. The notification can be specific (e.g., a text or audio notification instructing the user to “push the earpiece further into the ear canal” or “move the earpiece higher up on the pinna”) or non-specific (e.g., a flashing light or beeping sound that indicates the need to reposition the earpiece without providing detail on how specifically it should be repositioned). In an aspect, delivering a notification includes delivering a directional notification 4426. As used herein, the term “directional notification” refers a notification that provides information to the user regarding the direction of movement needed to move the earpiece to the proper position. For example, in an aspect, the notification includes a text or audio notification as described above, which instructs the user to “push the earpiece further into the ear canal” or “move the earpiece higher up on the pinna.” In another aspect, the notification includes a tone that changes in pitch as the earpiece moves toward or away from the proper location, or a click or other pulsed sound that is repeated at a frequency that changes as the earpiece moves toward or away from the proper location. In an aspect, the tone can change (i.e. changing to another tone, or stopping entirely) when the earpiece is in the proper location.
The vagus innervation of the ears is not strictly symmetrical; for example, the right ear, unlike the left ear, is innervated by a branch of the vagus nerve that, when stimulated, influences heart rate. Accordingly, in some circumstances it may be preferred to stimulate the left, but not the right ear, to avoid affecting the heart rate of the user. Therefore, if the system includes two earpieces (e.g., for the purpose of delivering music or other audio to both the left and right ear), in an aspect, only one of the earpieces includes a neural stimulator. For example, the earpiece with the neural stimulator is then considered to be usable on the left ear, but not the right ear. In some aspects, the two earpieces are shaped differently such that one fits the left, but not the right ear and the other fits the right, but not the left ear. In other aspects, the two earpieces are shaped such that they fit on either ear. In such a situation, the two earpieces may be distinguished from each other based on shape or color, or by inclusion of indicia on the earpiece or associated cable, and the ear stimulation device control system. A method 4500 as outlined in
An alternative approach to addressing the usability of neural stimulation with the right ear versus the left ear is to include stimulation electrodes in both earpieces, but send a neural stimulus control signal to cause delivery of a neural stimulus only via one of the earpieces (e.g., the left ear). In an aspect, a neural stimulus control signal is sent to only one of the earpieces. In an aspect, this is done if separate neural stimulus control signal outputs are provided for the two earpieces. In another aspect, a neural stimulus control signal is sent to both earpieces, but causes delivery of stimulus via only one of the earpieces. This can be done, e.g., by including ear stimulation electrical circuitry in the two earpieces that produces a neural stimulus in response to different neural stimulus control signals. For example, the neural stimulus control signal can have one or more characteristics (e.g., frequency, polarity, activation code) that cause activation of ear stimulation device control circuitry in one but not the other of the two earpieces. It is assumed that it is known a priori that a particular earpiece (as identified by the attribute determined in the user image) will receive and be activated by the neural stimulus control signal.
Image capture circuitry 4706 is adapted to capture an image 4712 of a user of computing device 4702 from user-facing imager 4704. In an aspect, user-facing imager is built into the computing device. In another aspect, user-facing imager 4704 is connected to computing device via either a wired or wireless connection. Image processing circuitry 4708 is configured to process image 4712, using parameter determination module 4714, to determine at least one parameter 4716. Neural stimulus control signal determination circuitry 4710 is configured to control delivery of a stimulus to at least one nerve innervating an ear of the user with an ear stimulation device 4732, based at least in part on the at least one parameter 4716. In various aspects, parameter 4716 is indicative of one or more of at least one emotion of the user, a physiological condition of the user, an identity of the user, or a heart rate of the user. In an aspect, parameter 4716 is related to an eye position or eye movement of the user. In an aspect, parameter 4716 is indicative of a position of the earpiece with respect to the ear of the user
In an aspect, image processing circuitry 4708 includes earpiece location module 4718, which is configured to process image 4712 to determine the presence 4735 of at least one earpiece 4719 of the ear stimulation device 4732 located at an ear of the user; the ear of the user at which the at least one earpiece is located, the ear selected from a right ear of the user and a left ear of the user; and at least one attribute 4733 of the at least one earpiece indicative of usability of the at least one earpiece 4719 with one of the left or the right ear of the user, as discussed herein above. Attribute 4733 may be, for example, an indicia 4721 used to indicate that the earpiece in question includes a neural stimulator, for example. In an aspect, neural stimulus control signal determination circuitry 4710 is configured (with earpiece location logic module 4720) to determine the ear at which the earpiece is usable, based on the at least one attribute 4733 of the at least one earpiece; determine whether the ear at which the at least one earpiece is located is the ear at which the earpiece is usable; and if the ear at which the at least one earpiece is located is not the ear at which the earpiece is usable, send a control signal from the computing device to the ear stimulation device (neural stimulus control signal 4722 from neural stimulus control signal output 4724) to prevent delivery of the stimulus to the a least one nerve innervating the ear of the user. As discussed herein above, in some circumstances it may be preferred to stimulate the left, but not the right ear, for example. Hence, in a system that includes two earpieces, the two earpieces may be distinguished from each other based on shape or color, or by inclusion of indicia on the earpiece or associated cable. In various aspects, indicia include any sort of markings detectable in the image via image processing. Indicia may include solid colored or patterned markings on an earpiece, or may include a characteristic of the earpiece itself (e.g., the color of the material of which the earpiece is made). Indicia may be detectable in the visible spectrum, or at other wavelengths. In some aspects, indicia may include text, alphanumeric markings, or symbols. The right and left ears of the user may be identified in user image 4712, using image processing methods, e.g. as described in M. M. Fakhir et al., “Face Recognition Based on Features Measurement Technique,” 2014 UKSim-AMSS 8th European Modelling Symposium, pp. 158-162; U.S. Patent Application Publication No. 2016/0026781 to Boczek et al.; and U.S. Patent Application Publication No. 2008/0285813 to Holm; each of which is incorporated herein by reference. In some aspects, the position of one or both ears with respect to the face is determined; in some aspects, the shape and/or features of one or both ears is determined.
In an aspect, ear stimulation device control system 4700 includes handshake circuitry 4726 adapted to receive a handshake signal 4728 from ear stimulation device control circuitry 4730 associated with the ear stimulation device 4732. In an aspect, image capture circuitry 4706 is adapted to capture the image 4712 of the user of the computing device 4702 responsive to receiving the handshake signal 4728 from the ear stimulation device control circuitry 4730. For example, in an aspect exchange of information between the ear stimulation device control system 4700 and ear stimulation device 4732 is initiated after user image 4712 has been captured and evaluated by image processing circuitry 4708, and it has been determined, by earpiece location logic module 4720, that the earpiece containing the ear stimulation device has been placed on the appropriate ear of the user. Alternatively, if two earpieces including ear stimulation devices are utilized, the handshake signal from each earpiece can include an earpiece identification code for identifying the earpiece. The earpiece identification code and indicia associated with a particular earpiece can be linked in a lookup table stored in data storage circuitry 4764, for example.
In an aspect, the neural stimulus control signal determination circuitry 4710 is configured to send a handshake signal 4734 to ear stimulation device control circuitry 4730 responsive to determining the presence 4735 of the at least one earpiece located at the ear of the user in the image.
In an aspect, ear stimulation device control system includes output device 4740, and notification circuitry 4742, which is adapted to provide a notification via output device 4740 instructing the user of to switch the earpiece to the other ear if the ear at which the at least one earpiece is located is not the ear at which the earpiece is usable.
For example, output device 4740 may be part of user interface 4744. In an aspect, output device is adapted to deliver a text notification 4746 to the user (e.g., output device includes an LED or LCD display, 7-segment display, or other alphanumeric display). In another aspect, output device 4740 is adapted to deliver a visible notification 4748 to the user, which may include a text display, as described previously, a graphic or symbol presented on a display, or a light that can be illuminated, flashed, etc. to attract the attention of the user. In an aspect, output device 4740 is adapted to deliver an audio notification 4750 to the user (e.g., output device 4740 includes a speaker, bell, buzzer, or other audio source for delivering one or both of a verbal notification or an alarm tone). User interface 4744 may also include one or more user input 4752, of various types, e.g. as discussed elsewhere herein.
As noted above, image processing circuitry 4708 includes earpiece location module 4718, which is configured to process image 4712 to determine at least one attribute 4733 of the at least one earpiece, where in an aspect the at least one attribute 4733 is indicative of usability of the at least one earpiece with one of the left or the right ear of the user. In addition, neural stimulus control signal determination circuitry 4710 is configured (with earpiece location logic module 4720) to determine the ear at which the earpiece is usable, based on the at least one attribute of the at least one earpiece. In an aspect, the at least one attribute of the at least one earpiece includes a shape of the at least one earpiece, a color of the at least one earpiece, a presence of an indicia 4721 on the at least one earpiece or a presence of indicia 4721 on an attachment to the at least one earpiece, where, as noted above, the attachment to the at least one earpiece may be, for example, a cable connected to the at least one earpiece. For example, in a system in which only one of two earpieces includes a stimulating electrode, the cable connected to the earpiece with the electrode may include a pattern of light and dark stripes, while the cable connected to the other earpiece may be a solid color. In embodiments in which two earpieces including ear stimulation devices are used, neural stimulus control signal determination logic can send a neural stimulus control signal 4722 sufficient to activate only an earpiece that is usable with the ear upon which it is located, based on the output of earpiece location logic module 4720.
In an aspect, image processing circuitry 4708 includes emotion determination module 4754, which determines an emotion of the user from user image 4712, based upon one or more parameter 4716, e.g. from facial expression, for example using methods as described in Su, “A simple approach to facial expression recognition,” Proceedings of the 2007 Int'l Conf on Computer Engineering and Applications, Queensland, Australia, 2007, pp. 456-461; U.S. Pat. No. 9,036,018 to Wang et al.; U.S. Pat. No. 8,488,023 to Bacivarov et al., and U.S. Patent Application Publication 2004/0207720 to Miyahara et al., each of which is incorporated herein by reference.
In an aspect, image processing circuitry 4708 includes physiological condition module 4756, which determines a physiological condition of the user from user image 4712, based upon one or more parameter 4716. Physiological condition of the user can be inferred from eye movement, pupil dilation, heart rate, respiration rate, facial coloration, facial temperature, etc. A visible or IR image of the patient, obtained with a camera built into a computing device or operatively connected to the computing device can be used. Still or moving (video) image may be used. For example, video images of the subject may be analyzed to determine blood flow using Eulerian video magnification. Further data analysis may be used to determine blood pressure in the subject. See, e.g., Wu et al., ACM Trans. Graph. 31, 4, Article 65, July 2012; (available online at http://doi.acm.org/10.1145/2185520.2185561), which is incorporated herein by reference. An infrared camera may be used to measure corneal temperature (see e.g., Kessel et al., Investigative Opthalmology and Visual Science 51: 6593-6597, 2010 which is incorporated herein by reference). An infrared camera with a focal plane array detector, thermal sensitivity ≤0.09 degrees C. and an accuracy of 0.1 degrees C. is available from Fluke Corp., Everett, Wash. (see e.g., Fluke Ti25 Datasheet which is incorporated herein by reference).
Peripheral sympathetic responses can be detected through image analysis, as described in IEEE TRANSACTIONS ON BIOMEDICAL ENGINEERING, VOL. 56, NO. 2, FEBRUARY 2009 477, Imaging Facial Signs of Neurophysiological Responses, Dvijesh Shastri, Associate Member, IEEE, Arcangelo Merla, Member, IEEE, Panagiotis Tsiamyrtzis, and Ioannis Pavlidis, Senior Member, IEEE, which is incorporated herein by reference. For example, thermal imaging measurements from several different regions of the face provide indication of blood flow, sweat gland activation, and breathing, providing information similar to galvanic skin response. In various aspects, physiological condition module 4756 is used to determine one or more medical condition, including, for example, muscle spasm, seizure, epilepsy (e.g., seizure , spasm, staring), drowsiness, lethargy, fatigue, pain, fever, hypertension (e.g., sweating, flushing), hypotension, mental state
In an aspect, image processing circuitry 4708 includes identity determination module 4758, which determines an identity of the user from user image 4712, based upon one or more parameter 4716. For example, systems and algorithms to obtain iris images, identify unique signatures and rapidly compare key features of iris images to a large database of iris images are described (see e.g., U.S. Pat. No. 5,572,596 issued to Wildes et al. on Nov. 5, 1996 and U.S. Pat. No. 4,641,349 issued to Flom et al. on Feb. 3, 1987 which are incorporated herein by reference). An iris scanning system which includes a near-infrared (approximately 700-900 nm) illumination source, a 1.3 megapixel camera and algorithms to analyze and compare iris images is available from Bayometric Inc., San Jose, CA (see e.g., the Specification Sheet: “Crossmatch Retinal Scan 2 Iris Scanner” which is incorporated herein by reference). In another aspect, facial recognition circuitry is used to determine the presence of the user through facial recognition, e.g., using approaches as described in Wheeler, Frederick W.; Weiss, R. L.; and Tu, Peter H., “Face Recognition at a Distance System for Surveillance Applications,” Fourth IEEE International Conference on Biometrics: Theory Applications and Systems (BTAS), 2010 Page(s): 1-8 (DOI: 10.1109/BTAS.2010.5634523), and Moi Hoon Yap; Ugail, H.; Zwiggelaar, R.; Rajoub, B.; Doherty, V.; Appleyard, S.; and Hurdy, G., “A Short Review of Methods for Face Detection and Multifractal Analysis, ” International Conference on CyberWorlds, 2009. CW '09. , Page(s): 231-236 (DOI: 10.1109/CW.2009.47), both of which are incorporated herein by reference. Biometric identification can also include recognition based on a variety of physiological or behavioral characteristics, such as fingerprints, voice, iris, retina, hand geometry, handwriting, keystroke pattern, etc., e.g., as described in Kataria, A. N.; Adhyaru, D. M.; Sharma, A. K.; and Zaveri, T. H., “A Survey of Automated Biometric Authentication Techniques” Nirma University International Conference on Engineering (NUiCONE), 2013, Page(s): 1-6 (DOI: 10.1109/NUiCONE.2013.6780190), which is incorporated herein by reference. U.S. Pat. No. 8,229,178 issued Jul. 24, 2012 to Zhang et al., which is incorporated herein by reference, describes a method for acquiring a palm vein image with visible and infrared light and extracting features from the image for authentication of individual identity. Biometric identification can be based on imaging of the retina or iris, as described in U.S. Pat. No. 5,572,596 issued to Wildes et al. on Nov. 5, 1996 and U.S. Pat. No. 4,641,349 issued to Flom et al. on Feb. 3, 1987, each of which is incorporated herein by reference. Combinations of several types of identity signals can also be used (e.g., speech and video, as described in Aleksic, P. S. and Katsaggelos, A. K. “Audio-Visual Biometrics,” Proceedings of the IEEE Volume: 94, Issue: 11, Page(s): 2025-2044, 2006 (DOI: 10.1109/JPROC.2006.886017), which is incorporated herein by reference).
In an aspect, image processing circuitry 4708 includes eye tracking module 4760, which determines an eye position or eye movement from user image 4712, based upon one or more parameter 4716. For example, a gaze tracking system for monitoring eye position is available from Seeing Machines Inc., Tucson, Ariz. (see e.g., the Specification Sheet: “faceLAB™ 5 Specifications” which is incorporated herein by reference). Eye position, eye rotation, eye gaze position against screen, pupil diameter and eye vergence distance may be monitored. Eye rotation measurements of up to +/−45 degrees around the y-axis and +/−22 degrees around the x-axis are possible. Typical static accuracy of gaze direction measurement is 0.5-1 degree rotational error. Eye position can be sensed using a method and system as described in U.S. Pat. No. 8,808,195 to Tseng et al., which is incorporated herein by reference, or by other methods described herein or known to those skilled in the relevant art. Eye position may include static or fixed eye position/gaze direction or dynamic eye position/eye movement. In an aspect, eye tracking module 4760 detects pupil diameter. Pupil diameter can be measured, for example, by methods as described in U.S. Pat. No. 6,162,186 to Scinto et al., which is incorporated herein by reference.
Ear stimulation device control system 4700 may include various other components as described generally elsewhere herein, including, but not limited to, e.g., communication circuitry 4762, data storage circuitry 4764, and reporting circuitry 4766. Similarly, ear stimulation device 4732 may include additional components, including but not limited to communication circuitry 4768 and stimulator driver circuitry 4770. In addition, ear stimulation device 4732 may include or be used in combination with a securing member 4772. In an aspect, the securing member includes or is a portion of an earpiece.
As described in connection with
In addition, in an aspect, application software on smart phone 4800 prompts the user to enter additional information regarding mood or other parameters, similar to application software 2908 described in connection with
As discussed herein above, in an aspect, image detection and analysis is used to detect improper placement of one or more earpieces on the ear(s) of a user of a computing device. In some aspects, it is desirable to detect quality of electrical contact between the ear and an electrode used for delivering electrical stimuli to or sensing electrical signals from the ear.
In an aspect, ear stimulation device control system 4904 includes handshake circuitry 4924 adapted to receive a handshake signal 4926 from ear stimulation device control circuitry 4928 associated with ear stimulation device 4902. In an aspect, ear stimulation device control system 4904 includes test signal circuitry 4930 configured to deliver an electrical test signal 4932 via at least one second electrode 4908 of the at least one ear stimulation device 4902, and detecting the electrical signal 4914 via the at least one first electrode 4906 responsive to electrical test signal 4932. In an aspect, contact determination circuitry 4916 is configured to determine an electrical impedance between the at least one first electrode 4906 and the at least one second electrode 4908. In an aspect, contact determination circuitry 4916 is configured to determine an amplitude of electrical signal 4914. In an aspect, contact determination circuitry 4916 is configured to determine a signal-to-noise ratio of electrical signal 4914. In an aspect, contact determination circuitry 4916 is configured to determine a phase shift or frequency content of the electrical signal 4914. In various aspects, contact determination circuitry 4916 includes amplitude determination module 4934 for determining the amplitude of electrical signal 4914, signal-to-noise ratio determination module 4936 for determining the signal-to-noise ratio of electrical signal 4914, or phase shift/frequency content determination module 4938 for determining the phase shift or frequency content of electrical signal 4914.
In an aspect, ear stimulation device 4902 includes earpiece 4940 which includes the at least one first electrode 4906. In an aspect, notification circuitry 4922 is configured to instruct the user to reposition earpiece 4940, replace at least a portion of the at least one first electrode 4906, clean at least a portion of the at least one first electrode 4906, moisten at least a portion of the at least one first electrode 4906, or apply gel to at least a portion of the at least one first electrode 4906. As discussed herein above, in various aspects, ear stimulation device 4902 includes or is used in connection with a securing member 4942, and may include additional circuitry components as described elsewhere herein, e.g. communication circuitry 4944 and stimulator driver circuitry 4946. In an aspect, notification circuitry 4922 is configured to deliver one or more of a text notification, a visible notification, or an audio notification. Neural stimulation system 4900 in various aspects includes other components as described elsewhere herein. For example, in various aspects computing device 4910 includes user interface 1214 including user input device 1362 and user output 1364, including audio output 1366, graphical display 1368, alphanumeric display 1392, or touchscreen 1394, as depicted in and described in connection with
Determining whether the at least one first electrode is in good electrical contact with the ear of the user can be performed by various methods, as discussed herein below. Good electrical contact can be defined by setting a threshold value for one or more measured parameter, such that contact is defined to be “good” if the measured parameter(s) are at or above the threshold value and “bad” if they are below the threshold parameter. In an aspect, determining whether the at least one first electrode is in good electrical contact includes providing a rating of the contact quality, e.g., “strong,” “moderate,” “usable but weak,” “unusable,” wherein any usable contact qualities are considered “good,” but contacts that are not usable are considered “bad.”
Further aspects and variants of method 5000 are depicted in
Computing device application 5306 includes audio delivery module 5310, mood assessment module 5312, secondary factor input module 5314, user control module 5316, stimulator control module 5318, and controller interface module 5320. The various modules include application software operating in connection with computing device hardware and software (i.e. the computing device hardware is configured by the application software) to provide the module functionality. Computing device 5306 includes other hardware and software components as described elsewhere herein as well as conventional hardware and software components not specifically described herein. The term “module,” as used herein, refers to application software operating on and used to configure computing device hardware to provide specialized circuitry functions of the device. In general, a module utilizes and in an aspect can be considered to incorporate both data storage circuitry and processing circuitry of the computing device.
Audio delivery module 5310 is adapted to control delivery of an audio signal from an audio signal source 5322 to an audio earpiece 5324 via an audio output 5326 of the computing device 5304, the audio earpiece 5324 having associated therewith ear stimulation device 5302 configured to stimulate a nerve innervating the ear of the user. Audio signal source 5322 may be, for example an audio player application 5324, a web radio application 5326, a radio receiver 5328, a telephone receiver 5330, or a hearing aid 5331.
Mood assessment module 5312 is adapted to receive mood-related input from the user via a first input structure 5332 associated with the computing device, and assess a mood of the user based at least in part upon the mood-related input. In an aspect, mood assessment module 5312 includes an ecological momentary assessment module 5334.
Ecological momentary assessment module 5334 includes application software on the person computing device that collects information about the user's behaviors and experiences from the user, by querying the user at intervals during the day as they go about their usual activities in their “natural environment” (as contrasted to self-reports of mood based on the user's recollections during a clinic visit, for example), e.g. as described generally in Shiffman et al., “Ecological Momentary Assessment,” Annual Review of Clinical Psychology, Vol. 4:1-32, April 2008 (First Published Online Nov. 28, 2007), DOI: 10.1146/annurev.clinpsy.3.022806.091415, which is incorporated herein by reference. In some aspects, mood assessment module 5312 includes activity assessment module 5335, which tracks and analyzes user activities involving use of the computing device (e.g. use of social media, web searches, speech patterns, typing patterns, including amount and/or type of use) to determine mood of the user. For example, in an aspect, activity assessment module 5335 analyzes typing patterns using, for example, techniques as described in U.S. Pat. No. 6,231,344 to Merzenich et al., U.S. Published Patent Application 2005/0084832 to Janssen et al., each of which is incorporated herein by reference. In an aspect, activity assessment module 5335 determines the timing of entry of instructions by the patient. In an aspect, it is not necessary to determine the specific instructions entered by the patient, but only to determine how often the patient is using the computing device, and/or how quickly the patient is entering instructions into the computing device. In other aspects, the specific instructions can be detected, e.g., to determine whether the patient is choosing to listen to music, play a game, send or read email, receive a phone call, or place a phone call. Sensing and processing of game controller signals, e.g., to determine reaction times, may be substantially as described in U.S. Pat. No. 5,913,310 to Brown, or U.S. Pat. No. 6,186,145 to Brown, both of which are incorporated herein by reference. It will be appreciated that while Brown describes a video game designed primarily for health care-related teaching purposes, the video game may be for entertainment purposes, and need not include an educational or medical component. In an aspect, activity assessment module 5335 is configured to process an audio signal (detected from a cell phone, for example) to determine a speech pattern of the patient. In an aspect, mood assessment module 5312 includes image processing module 5336 adapted to determine a mood of the user based on image analysis of an image of the user detected with a user-facing imager 5338 of the computing device 5304, e.g., as discussed herein above. In various aspects, mood assessment module 5312 is adapted to receive mood-related input relating to depression, stress, or emotion, for example. First input structure 5332 of the computing device in various aspects includes a touch screen 5340, a keyboard, or a microphone.
Secondary factor input module 5314 is adapted to receive at least one input relating to at least one secondary factor relating to the user via a second input structure 5350 associated with computing device 5304. Secondary input structure 5350 of computing device 5304 includes at least one of a touch screen 5340, a keyboard 5342, a microphone 5344, a device interface 5352, a data input 5354, USB port 5356, a wireless interface 5358, a serial port 5360, and a parallel port 5362. Touch screen 5340, a keyboard 5342, a microphone 5344, are examples of components of a user interface 5364, although it will be appreciated that input may be received by other types of user interface devices, as are known to those of skill in the art. Data input 5354, USB port 5356, wireless interface 5358, serial port 5360, and parallel port 5362 are examples of device interface 5352; other device interfaces may be used as well. First input structure 5332, second input structure 5350, and third input structure 5366 may in some aspects be the same type of input structure, and indeed may be the same input structure. In other aspects, one or more of first input structure 5332, second input structure 5350, and third input structure 5366 are the same type of input structure, but are distinct input structures. In some aspects, first input structure 5332, second input structure 5350, and third input structure 5366, are different types of input structures, and, in addition, are distinct input structures.
In an aspect, secondary factor input module 5314 is adapted to receive at least one input from the user, i.e., via user interface 5364. In another aspect, secondary factor input module is adapted to receive at least one input from a sensor 5368, e.g., via data input 5354 or another device interface. In another aspect, secondary factor input module 5314 is adapted to receive at least one input via a computing network 5370.
User control module 5316 is adapted to receive at least one user control input via a third input structure 5366 of the computing device, the user control input for controlling user-controllable stimulation parameters of the ear stimulation device.
Stimulator control module 5318 is adapted to determine at least one stimulus control parameter based on at least one of the mood of the user, the at least one secondary factor, and the at least one user control input.
Controller interface module 5320 is used for communicating the at least one stimulus control parameter to a stimulator controller adapted to control the ear stimulation device responsive to the at least one stimulus control parameter.
In an aspect, stimulator control module 5318 is configured to coordinate delivery of the audio signal with delivery of at least one stimulus with ear stimulation device 5302.
In an aspect, secondary factor input module 5314 is adapted to receive at least one input relating to an environmental condition of the user, for example, including at least one of a light level, a temperature, a humidity, a pollen count, a noise level, a day length, a precipitation, an air quality measure. In another aspect, secondary factor input module 5314 is adapted to receive at least one input relating to sleep pattern of the user. In another aspect, secondary factor input module 5314 is adapted to receive at least one input relating to medical history of the user. In another aspect, secondary factor input module 5314 is adapted to receive at least one input relating to an activity of the user, including, but not limited to a physical activity, a health-related activity, a recreational activity, a social activity, an employment activity, a purchasing activity, a mental activity, a spiritual activity, a media-related activity, an activity of daily life, an amount of activity, a duration of activity, a frequency of activity, a timing of activity, a calendar, a schedule, or a cost. In another aspect, secondary factor input module 5314 is adapted to receive at least one input relating to a diet of the user or an appetite of the user. An input relating to a secondary factor may include user input relating to the secondary factor, received for example, via user interface 5364. In an aspect, secondary factor input module 5314 is adapted to receive at least one open ended comment from the user, e.g. via text input 5374. In another aspect, secondary factor input module 5314 is adapted to provide a drop down menu 5376 of selectable items and receive from the user a selection from the drop down menu. For example, in an aspect, the menu of selectable items includes topic areas for discussion with a medical care provider. In addition to text inputs or menus, various types of input elements may be utilized to receive input from the user, voice to text conversion, screen elements with clickable buttons or checkboxes that allow the user to select from multiple options, sliders that allow the user to increase or decrease a parameter value between minimum and maximum values, and various other types of input elements.
In an aspect, computing device application 5306 includes a recommendation delivery module 5378, which is configured to present a recommendation to the user. For example, the recommendation can be presented to the user via user interface 5364, or audio output 5326, or sent to a remote device via device interface 5352, computing network 5370, or communication network 5380. In an aspect, recommendation delivery module 5378 is adapted to receive the recommendation from a medical care provider, from an insurance company, a service provider, an advisor, a computation-based system, or a social media source. For example, in an aspect recommendation delivery module 5378 is adapted to receive a recommendation via computing network 5370. For example, in an aspect the recommendation based on patients similar to the user. In an aspect, recommendation delivery module 5378 is adapted to generate the recommendation.
In an aspect, computing device application 5306 includes a correlation module 5382 configured to determine at least one correlation between the mood of the user and at least one of the at least one secondary factor and the at least one stimulus control parameter, and recommendation delivery module is configured to generate the recommendation based at least in part on the at least one correlation. For example, if it is determined that a particular secondary factor (e.g., rainy weather) is normally followed by a depressed mood in the user, if occurrence of the secondary factor is detected, a recommendation is generated for increasing stimulation. As another example, if a particular activity of the user is correlated with depression (for example, if the user reports being depressed after staying up late and not getting enough sleep, the recommendation might be to go to bed earlier).
In an aspect, recommendation delivery module 5378 is adapted to provide the recommendation to a medical care provider of the user. This can be done, for example, by sending the recommendation to a remote device used by the medical care provider, via computing network 5370, communication network 5380, device interface 5352, or via user interface 5364. Providing the recommendation to the medical care provider makes it possible for the medical care provider to discuss the recommendation with the user, or not, as deemed appropriate by the medical care provider, as well as to incorporate the recommendation into an overall treatment plan for the user.
In an aspect, recommendation delivery module 5378 is configured to generate the recommendation based on at least one of information regarding a response of the subject to a past treatment regimen, information obtained via social media, information regarding at least one preference of at least one social media contact of the subject, information regarding at least one preference of at least one peer of the subject, information regarding at least one preference of at least one role model of the subject, information from an insurance company, information from a service provider.
In an aspect, recommendation delivery module 5378 is configured to generate the recommendation with a computation-based system; for example, an artificial intelligence, a neural network, or a machine learning system. In an aspect, recommendation delivery module 5378 is configured to generate the recommendation based on a predicted response of the subject to a treatment regimen.
In another aspect, recommendation delivery module 5378 is configured to receive information regarding whether the subject has accepted or rejected the recommendation. In various aspects, recommendation delivery module 5378 is configured to present to the user a recommendation for a configuration of the neural stimulus, or a recommendation for a secondary stimulus to be delivered in association with the neural stimulus.
In an aspect, computing device application 5306 includes physiological data module 5384 adapted to receive at least one physiological data signal representing at least one physiological parameter of the user. In an aspect, physiological data module 5384 is adapted to receive the at least one physiological data signal from at least one sensor 5368. In another aspect, physiological data module 5384 is adapted to receive the at least one physiological data signal from at least one computing network 5370, or alternatively, via at least one communication network 5380. In another aspect, physiological data module 5384 is adapted to receive the at least one physiological data signal from at least one remote sensing system 5386. A remote sensing system may include one or more sensors in the environment of the user, including but not limited to imagers, motion sensors, pressure sensors, force sensors, infrared sensors, etc. In various aspects, physiological data module 5384 is adapted to receive the at least one physiological data signal from at least one of a blood pressure sensor, a heart rate sensor, a chemical sensor, a biosensor, a pH sensor, a blood oxygen sensor, a galvanic skin response sensor, an EEG sensor, an EMG sensor, an ECG sensor, a wearable item, an eye tracking system, an acoustic sensor, a motion sensor, a force transducer, or an activity sensor.
In an aspect, user control module 5316 is adapted to receive user input (e.g., via user interface 5364) for controlling at least one of stimulus pulse amplitude, stimulus pulse duration, stimulus frequency, stimulus pulse pattern, and stimulus pulse envelope.
In an aspect, computing device application 5306 includes external control module 5388, which is configured to receive an external control input for controlling at least one externally controllable stimulation parameter of the ear stimulation device. For example, in various aspects, external control module 5388 is configured to receive the external control input via computing network 5370 or communication network 5380. In an aspect, external control module 5388 is configured to receive the external control input from an external party or entity. In an aspect, the external party or entity is a medical care provider. In other aspects, the external control input may be received from other external parties or entities, e.g., a family member, an insurance company, the device manufacturer, etc. The at least one externally controllable stimulation parameter includes, for example, at least one of stimulus pulse amplitude, stimulus pulse duration, stimulus frequency, stimulus pulse stimulation pattern, and stimulus pulse envelope. Externally controllable stimulation parameters may include preferred values for efficacy of treatment, including preferred values to be used in connection with different patent conditions, or upper and lower limits for stimulus values, for purposes of patient safety or efficacy of treatment.
In another aspect, computing device application 5306 includes data transfer module 5390 for providing data relating to the user to an external party or entity. In an aspect, data transfer module 5390 is configured to provide the data to the external party or entity via computing network 5370. In another aspect, data transfer module is configured to provide the data to the external party or entity via communication network 5380. For example, the external party or entity may be a medical care provider, a family member, an insurance company, a service provider, a social media contact (or ‘friend’) of the subject, a peer of the subject, an advisor, a computation based system, a social media source, a device manufacturer, a merchant, an electronic medical record, a sensor network, or an additional program or application, for example. In an aspect, a sensor network includes or is part of a health diary platform, a smart home, or an internet of things.
In an aspect, stimulator control module 5318 is configured to determine the at least one stimulus control parameter 5334 by overriding the at least one user control input for controlling the at least one user-controllable stimulation parameter based on a medical-care provider control input. Alternatively, in another aspect, stimulator control module 5318 is configured to override a medical-care provider control input based on the at least one user control input for controlling the at least one user-controllable stimulation parameter. In yet another aspect, stimulator control module 5318 is configured to override the at least one user control input for controlling the at least one user-controllable stimulation parameter based on a computing system-generated stimulus control parameter. In another aspect, stimulator control module 5318 is configured to override a computing system-generated stimulus control parameter based on the at least one user control input for controlling the at least one user-controllable stimulation parameter. For example, stimulator control module 5318 is configured to determine the at least one stimulus control parameter to provide an initial setting of the ear stimulation device based on the at least one user-controllable stimulation parameter. In another aspect, stimulator control module 5318 is configured to determine the at least one stimulus control parameter to update a setting of the ear stimulation device based on the at least one user-controllable stimulation parameter.
Further aspects of the method shown in
For example, as shown in
Receiving the mood-related input in various aspects includes receiving user input via an ecological momentary assessment module, as indicated at 5512; receiving an image of the user with a user-facing imager of the computing device, and determining a mood of the user based on image analysis of the image of the user with image processing software of the mood assessment module, as indicated at 5514. Mood assessment based on image analysis is discussed in greater detail herein above. Receiving the mood-related input may include receiving mood-related input relating to one or more of depression, as indicated at 5516; stress, as indicated at 5518; emotion, as indicated at 5520; or a mental disorder, as indicated at 5522. In an aspect, receiving the mood-related input via the first input structure includes receiving at least one input via a touch screen, a keyboard, or a microphone, as indicated at 5524. In an aspect, method 5500 includes coordinating, with the stimulator control module, delivery of the audio signal with delivery of at least one stimulus with the ear stimulation device, as indicated at 5524.
In another aspect, receiving at least one input relating to at least one secondary factor relating to the user with the secondary factor input module includes receiving at least one input relating to an environmental condition of the user, as indicated at 5610. An environmental condition may include, for example, at least one of a light level, a temperature, a humidity, a pollen count, a noise level, a day length, a precipitation, an air quality measure, as indicated at 5612.
In other aspects, receiving at least one input relating to at least one secondary factor relating to the user with the secondary factor input module includes receiving at least one input relating to a sleep pattern of the user, as indicated at 5614; a medical history of the user, as indicated at 5615; a diet of the user, as indicated at 5616; an appetite of the user, as indicated at 5618; or an activity of the user, as indicated at 5620. For example, receiving at least one input relating to an activity includes receiving at least one input relating to, e.g., a physical activity, a recreational activity, a social activity, an employment activity, a purchasing activity, a mental activity, a spiritual activity, a media-related activity, an activity of daily life, an amount of activity, a duration of activity, a frequency of activity, a timing of activity, a calendar, a schedule, or a cost, as indicated at 5622.
In further aspect, receiving at least one input relating to at least one secondary factor relating to the user with the secondary factor input module includes receiving at least one open ended comment from the user, as indicated at 5624. In other aspects, receiving at least one input relating to at least one secondary factor relating to the user with the secondary factor input module includes providing a drop down menu of selectable items and receiving from the user a selection from the drop down menu, as indicated at 5626. For example, in an aspect, providing a drop down menu of selectable items includes providing a drop down menu of selectable topic areas for discussion with medical care provider, as indicated at 5628.
As shown in
In various aspects, presenting the recommendation includes presenting a recommendation for a configuration of the neural stimulus, as indicated at 5712, or presenting a recommendation for a secondary stimulus to be delivered in association with the neural stimulus, as indicated at 5714.
In an aspect, method 5700 includes delivering a recommendation based on patients similar to the user, as indicated at 5716.
In an aspect, method 5700 includes generating the recommendation with the recommendation delivery module, as indicated at 5718. For example, the method may include determining, with a correlation module, at least one correlation between the mood of the user and at least one of the at least one secondary factor and the at least one stimulus control parameter, and generating the recommendation with the recommendation delivery module based at least in part on the at least one correlation, as indicated at 5720. In an aspect, the method includes generating the recommendation based on at least one of information regarding a response of the subject to a past treatment regimen, information obtained via social media, information regarding at least one preference of at least one social media contact of the subject, information regarding at least one preference of at least one peer of the subject, information regarding at least one preference of at least one role model of the subject, information from an insurance company, information from a service provider, as indicated at 5722. In some aspects, the method includes generating the recommendation with a computation-based system, as indicated at 5724, or generating the recommendation based on a predicted response of the subject to a treatment regimen, as indicated at 5726.
In an aspect, receiving the at least one physiological data signal includes receiving the at least one physiological data signal from at least one computing network, as indicated at 5810, or from at least one remote sensing system, as indicated at 5812. In various aspects, receiving the at least one physiological data signal includes receiving the at least one physiological data signal from at least one of a blood pressure sensor, a heart rate sensor, a chemical sensor, a biosensor, a pH sensor, a blood oxygen sensor, a galvanic skin response sensor, an EEG sensor, an EMG sensor, an ECG sensor, a wearable item, an eye tracking system, an acoustic sensor, a motion sensor, a force transducer, or an activity sensor, as indicated at 5814.
In a further aspect, method 5800 includes providing data relating to the user to an external party or entity, as indicated at 5816. In various aspects, providing the data to the external party or entity includes providing the data via a computing network, as indicated at 5818, or providing the data via a communication network, as indicated at 5820. In an aspect, providing the data to the external party or entity includes providing the data to a medical care provider, as indicated at 5822. In various aspects, providing the data to the external party or entity includes providing the data to a family member, an insurance company, a service provider, a social media contact of the subject, a peer of the subject, an advisor, a computation based system, a social media source, a device manufacturer, a merchant, an electronic medical record, a sensor network, a program or an application, as indicated at 5824.
In another aspect, method 5900 includes determining, with a correlation module, at least one correlation between the mood of the user and at least one of the at least one secondary factor and the at least one stimulus control parameter, as indicated at 5904.
In another aspect, method 5900 includes receiving, with an external control module, an external control input for controlling at least one externally controllable stimulation parameter of the ear stimulation device, as indicated at 5906. In various aspects, this includes receiving the external control input via a computing network or a communication network, as indicated at 5908. In an aspect, receiving the external control input includes receiving the external control input from an external party or entity, as indicated at 5910, for example, a medical care provider, as indicated at 5912, or a family member, an insurance company, a service provider, a social media contact of the subject, a peer of the subject, an advisor, a computation based system, a social media source, a device manufacturer, a merchant, an electronic medical record, a sensor network, a program or an application, as indicated at 5914. In various aspect, the at least one externally controllable stimulation parameter includes at least one of stimulus pulse amplitude, stimulus pulse duration, stimulus frequency, stimulus pulse pattern, and stimulus pulse envelope, as indicated at 5916.
In an aspect, determining the at least one stimulus control parameter includes determining an initial setting of the ear stimulation device based on the at least one user-controllable stimulation parameter, as indicated at 6010. In another aspect, determining the at least one stimulus control parameter includes updating a setting of the ear stimulation device based on the at least one user-controllable stimulation parameter, as indicated at 6012.
In an embodiment, the one or more neural stimulators 6102 can include a plurality of neural stimulators, such as a first neural stimulator 6102a, a second neural stimulator 6102b, and a third neural stimulator 6102c. Each of the neural stimulators 6102 can include a stimulator 6108 that is configured to apply a stimulus to a subject. For example, the stimulator 6108 can include an electrode if the neural stimulator 6102 is an electrical stimulator, a piezoelectric if the neural stimulator 6102 is a ultrasonic stimulator or a vibratory stimulator, a thermoelectric or heating coil if the neural stimulator 6102 is a thermal stimulator, an electromagnet if the neural stimulator 6102 is a magnetic stimulator, etc.
In an embodiment, each of the neural stimulators 6102 can include a corresponding amplifier 6112. For example, the neural stimulation system 6100 can include a power source 6110 (e.g., battery) that is configured to provide electrical power to at least the neural stimulators 6102. However, the power source 6110 may be limited in the amount of electrical power that can be provided to the neural stimulators 6102. As such, the neural stimulators 6102 can include an amplifier 6112 that is configured to increase the electrical power received by the neural stimulators 6102. In an embodiment, as illustrated, each of the neural stimulators 6102 can include an amplifier 6112 which allows an amplitude of the stimulus provided by each of the neural stimulators 6102 to different. In such an embodiment, the neural stimulation system 6100 can include a stimulator module 6114 that supports two or more of the amplifiers 6112. In an embodiment, at least some of the neural stimulators 6102 can share a common amplifier which can simplify the neural stimulation system 6100 and decrease the cost of manufacturing the neural stimulation system 6100.
In an embodiment, the neural stimulation system 6100 can include at least one stimulator sensor 6116 that is configured to detect one or more characteristics of the neural stimulators 6102. For example, the stimulator sensor 6116 can be configured to detect at least one of an electrical power that is provided to the neural stimulators 6102 (e.g., electrical power provided to the amplifiers 6112), an electrical power that is outputted from the amplifiers 6112, or one or more characteristics of the stimulus that is provided to the subject (e.g., an electrical current or electrical field applied to the subject when the neural stimulators 6102 are electrical stimulators). The stimulator sensor 6116 can be communicably coupled to the control circuitry 6104 and the control circuitry 6104 can at least partially control the operation of the neural stimulators 6102 responsive to receiving the detected characteristics from the stimulator sensor 6116. In an embodiment, the stimulator sensor 6116 can be at least partially disposed on the stimulator module 6114.
The control circuitry 6104 is coupled to and configured to at least partially control the operation of the neural stimulators 6102. For example, the control circuitry 6104 can include a control/processing circuitry 6118 that is configured to at least partially control the operation of the neural stimulators 6102. The control/processing circuitry 6118 can include any suitable circuitry, such as a microcontroller unit. The control circuitry 6104 can also include a variety of components that couple the control/processing circuitry 6118 to the neural stimulators 6102 and facilitate the operation of the control/processing circuitry 6118. For example, the control circuitry 6104 can include at least one of a neural stimulator selection matrix 6120, a digital-to-analog converter coupling 6122 the control/processing circuitry 6118 to the neural stimulator selection matrix 6120, or a sequence generation logic module 6124 coupling the control/processing circuitry 6118 to the neural stimulator selection matrix 6120.
The control circuitry 6104 is configured to communicably couple the stimulator sensor 6116 to the control/processing circuitry 6118. For example, the control circuitry 6104 can include an amplifier 6126 that is configured to increase a signal from the stimulator sensor 6116. The control circuitry 6104 can also include at least one of an analog-to-digital converter 6130 coupling the amplifier 6126 to the control/processing circuitry 6118 or an overcurrent detection module 6130 coupling the amplifier 6126 to the control/processing circuitry 6118.
The control circuitry 6104 can also include a transmitter 6132 that is configured to couple the neural stimulation system 6100 to another component, such as a computing device or a remote system. The transmitter 6132 can include any suitable transmitter. For example, the transmitter 6132 can include a Bluetooth communication device, such as a BLE 4.2 subsystem or a BLE 5.0 subsystem. It is noted that the components of the control circuity 6104 can be spaced from an antenna of the Bluetooth communication device thereby
The neural stimulation system 6100 can also include one or more additional components. In an example, the neural stimulation system 6100 can include a battery protection circuitry 6134 coupled to the power source 6110 that is configured to protect (e.g., prevent overcharge, over-discharge, manage discharge current, etc.) and increase the lifespan of the power source 6110. In an example, the neural stimulation system 6110 can include a boost regulator circuitry 6136 between the power source 6110 and the neural stimulators 6102. In an example, the neural stimulation system 6110 can include an inter-integrated circuit 6138 (I2C) that couples one or more components of the neural stimulation system 6110 to the control circuitry 6104 and/or the control/processing circuitry 6118. For instance, the inter-integrated circuit 6138 can couple the sensor 6106 to the control/processing circuitry 6118. In an example, the neural stimulation system 6110 can include a light emitting diode indicator 6140 or other suitable indicator (e.g., display) that is configured to display information. In an example, the neural stimulation system 6110 can include a debug interface 6142 that is configured to provide in-circuit debugging functionality to the control circuitry 6104.
The main body 6204 can be configured to house most of the components of the neural stimulation system 6200 therein. For example, the main body 6204 can include at least one of control circuitry, a power source, at least one amplifier, or at least one sensor disposed therein. The main body 6204 can also include one or more neural stimulators (e.g., any of the neural stimulators disclosed herein), such as one or more neural stimulators 6211 disposed on the contact surface 6205 of the main body 6204. In another example, the main body 6204 can include one or more indicators (e.g., LED indicator, display, etc.) that are configured to communicate information. For instance, the main body 6204 can include an LED indicator 6209 on the distal surface 6208 of the main body 6204.
The neural stimulation system 6200 also includes at least one extension 6210 extending from the main body 6204. The extension 6210 can be configured to wrap behind the helix 6212 of the pinna 6206. As such, the main body 6204 and the extension 6210 form a generally hook shape that wraps around the pinna 6206 and secures the neural stimulation system 6200 to the pinna 6206. The extension 6210 is configured to contact specific portions of the anterior surface 6214 of the pinna 6206. The portions of the anterior surface 6214 that the extension 6210 is configured to contact can depend on the nerve that is to be stimulated by the neural stimulation system 6200. In an embodiment, the extension 6210 can be configured to contact two or more portions of the pinna 6206. In such an embodiment, the extension 6210 can include at least one branch 6216 extending from a main portion 6218 of the extension 6210. For example, as illustrated, the extension 6210 can include two branches 6216 extending from the main portion 6218 of the extension 6210. The two branches 6216 can be configured to contact a cymba 6220 and the cavum 6222 of the pinna 6206.
The neural stimulation system 6300 can include at least one extension. For example, the neural stimulation system 6300 can include a first extension 6310a extending from the main body 6304. The first extension 6310a is configured to extend behind a helix 6312 of the pinna 6306 and contact a posterior surface (not shown, obscured) of the pinna 6306. In an example, the neural stimulation system 6300 can also include a second extension 6310b extending from the main body 6304. The second extension 6310b can be configured to contact the anterior surface 6314 of the pinna 6304, such as at least one of the cymba (not shown, obscured) or the cavum 6322. In an embodiment, the first extension 6310a and the second extension 6310b can include one or more neural stimulators. In such an embodiment, the neural stimulators of the first extension 6310a can be configured to contact selected portions of the posterior surface and the neural stimulators of the second extension 6310b can be configured to contact corresponding portions of the anterior surface 6314.
The neural stimulation system 6400 can include at least one extension. For example, the neural stimulation system 6400 can include a first extension 6410a extending from the main body 6404. The first extension 6410a is configured to extend behind a helix 6412 of the pinna 6406 and contact a posterior surface (not shown, obscured) of the pinna 6406. In an example, the neural stimulation system 6400 can also include a second extension 6410b extending from the main body 6404. The second extension 6410b can be configured to extend behind a lobe 6432 of the pinna 6406 and contact the posterior surface of the pinna 6406. The first extension 6410a and the second extension 6410b can secure the neural stimulation system 6400 to the subject 6402. In an example, the neural stimulation system 6400 can also include a third extension 6410c extending from the main body 6404. The third extension 6410c can contact the anterior surface 6414 of the pinna 6404, such as at least one of the cymba (not shown, obscured) or the cavum 6422. In an embodiment, the first extension 6410a, the second extension 6410b, and the third extension 6410c can include one or more neural stimulators. In such an embodiment, the neural stimulators of the first and second extensions 6410a, 6410b can be configured to contact selected portions of the posterior surface and the neural stimulators of the third extension 6410c can be configured to contact corresponding portions of the anterior surface 6414.
The neural stimulation system 6500 can include at least one extension. For example, the neural stimulation system 6500 can include an extension 6510 extending from the main body 6504. The extension 6510 is configured to extend from behind the pinna 6506 and over the lobe 6532 of the pinna 6506. The extension 6510 also extends into and obstructs the ear canal (not shown, obscured). Extending the extension 6510 into the ear canal can attach the neural stimulation system 6500 to the subject 6502. In an embodiment, the neural stimulation system 6500 can include any of the sound passthroughs disclosed herein since the extension 6510 obstructs the ear canal. The extension 6510 can also include at least one branch 6516 extending therefrom. The branch 6516 can be configured to contact one or more selected portions of the anterior surface 6514 of the pinna 6506. For example, the extension 6510 can include two branches 6516; one of the branches 6516 can be configured to contact the cymba 6520 and the other branch 6516 can be configured to contact the cavum 6522. It is noted that the neural stimulation system 6500 can include one or more additional extensions extending from the main body 6504, such as one or more additional extensions extending from the main body 6504 behind the pinna 6506.
In an embodiment, the extension 6510 (e.g., the branches 6516) and the main body 6504 can include one or more neural stimulators. For example, the main body 6504 can be configured to contact selected portions of the posterior surface, and the neural stimulators of the extension 6510 can be configured to contact corresponding portions of the anterior surface 6514.
The neural stimulation system 6600 can include at least one extension 6610. The extension 6610 can extend from the main body 6604. The extension 6610 can be configured to extend around the lobe 6632 of the pinna 6606. The extension 6610 can also extend into and obstruct the ear canal 6607. Extending the extension 6610 into the ear canal can attach the neural stimulation system 6600 to the subject 6602. In an embodiment, the neural stimulation system 6600 can include any of the sound passthroughs disclosed herein, such as a recess 6634 extending through the extension 6610. The extension 6610 can also include at least one branch 6616 extending therefrom. The branch 6616 can be configured to contact one or more selected portions of the anterior surface 6614 of the pinna 6606. For example, the extension 6610 can include two branches 6616; one of the branches 6616 can be configured to contact the cymba 6620 and the other branch 6616 can be configured to contact the cavum 6622. It is noted that the neural stimulation system 6600 can include one or more additional extensions extending from the main body 6604, such as one or more additional extensions extending from the main body 6604 behind the pinna 6606.
In an embodiment, the extension 6610 and the main body 6604 can include one or more neural stimulators. For example, the main body 6604 can be configured to contact selected portions of the posterior surface and the neural stimulators of the extension 6610 can be configured to contact corresponding portions of the anterior surface 6614.
The main body 6704 can be formed from a plurality of pieces. For example, the main body 6704 can include a housing back 6708 and a housing front 6710 that are configured to be coupled together. For example, the housing back 6708 and the housing front 6710 can be configured to be coupled together using a glue (e.g., cyanoacrylate), using clips, or using another suitable attachment mechanism.
Referring to
The main body 6702 can be configured to minimize the size and weight of the neural stimulation system 6700. As such, the main body 6702 is configured to minimize the volume of the interior chamber 6712 which limits the space available for the components of the neural stimulation system 6700. In an example, the main body 6702 can include curved walls and ribs which can increase the packing efficiency of the components in the main body 6702 while also maximizing the mechanical strength of the main body 6702. In an example, the main body 6702 can exhibit a width “W” that is about 15 mm to about 20 mm (e.g., about 17 mm), a length “L” of about 25 mm to about 30 mm (e.g., about 27 mm), and a thickness “T” of about 7.5 mm to about 12.5 mm (e.g., about 9.25 mm).
The neural stimulation system 6700 is primarily driven by the battery 6714 and the circuit board 6716. The circuit board 6716 can include a main board 6724 and at least one secondary board 6726 extending from the main board 6724. The circuit board 6716 can exhibit a folded configuration (e.g., the secondary board 6726 is disposed behind the main board 6724) which can minimize the size of the main body 6702. The main board 6724 can include at least one of control circuitry 6728 (e.g., programmable system-on-chip), an LED 6730 which forms part of the user interface 6718, or treatment circuitry. The secondary board 6726 can include at least one of a power circuitry 6732 that is connected to at least one of the battery 6714 or the charge contacts 6720. The circuit board 6716 can also define one or more alignment holes 6734 configured to align and/or secure the circuity board 6716 in the interior chamber 6712. Wires (not shown) can extend from the circuit board 6716 to the at least one electrode 6706.
The charge contacts 6720 can be gold plated to achieve a small size that decreases the size of the main body 6702. The charge contacts 6720 are configured to contact (e.g., mate) with opposing contacts of the battery charger. As previously discussed, the charge contacts 6720 can be mounted to the circuit board 6716. The main body 6702 can define holes 6736 that the charge contacts 6720 are configured to extend at least partially through. The charge contacts 6720 and/or the holes 6736 can include a polymer (e.g., pressure-sensitive adhesive) or other sealant which prevents fluid or other debris from entering the interior chamber 6712. The charge contact 6720 can include at least one contact, such as two contacts (e.g., two contacts for charging) or three contacts (e.g., two contacts for charging and one contact for charge detection).
The user interface 6718 can include any of the user interfaces disclosed herein. As illustrated, the user interface 6718 can include an LED 6730. The LED 6730 can indicate the status of the neural stimulation system 6700. For example, the LED 6730 can emit a first color indicating a first status (e.g., a red light which indicates a warning status), a second color indicating a second status (e.g., a green light which indicates that the neural stimulation system 6700 is ready to use), or one or more additional colors that each indicate different statuses. The user interface 6718 can also include a diffuser 6738. The diffuser 6738 can be a small semi-clear or clear component configured to move light from the LED 6730 to a surface of the main body 6702. The diffuser 6738 can be secured to the main body 6702 and/or the circuity board 6716 using an adhesive or any other suitable method.
As previously discussed, the neural stimulation system 6700 can include at least one extension 6704 extending from the neural stimulation system 6700. The extension 6704 can include a first branch 6740 configured to contact at least the concha of the ear and a second branch 6742 that is configured to attach the neural stimulation system 6700 to the ear. The first and second branches 6740, 6742 can extend from a common portion 6744 of the extension 6704. At least the common portion 6744 can be coupled to the main body 6702. For example, the extension 6704 can be coupled to the main body 6702 using an adhesive layer 6745 or any other suitable method. The common portion 6744 can also include at least one electrode and/or be configured to contact a portion of the concha. The extension 6704 can be configured to not rotate relative to the main body 6702.
The extension 6704 can include an electrode skeleton 6746 is configured to align the at least one electrode 6706. For example, the electrode skeleton 6746 can be configured to apply an inward electrode force against the ear such that the electrode 6706 maintains contact with the ear during normal use. Further, the electrode skeleton 6746 can be configured to position the electrode 6706 such that the electrode 6706 contacts specific location(s) on the ear. The electrode skeleton 6746 can form at least a portion of the first branch 6740, the second branch 6742, and the common portion 6744. At least the portion of the electrode skeleton 6746 that forms the first branch 6740 can be formed of a semi-flexible material (e.g., urethane) so that the first branch 6740 has flexibility in all directions. The flexibility of the first branch 6740 allows the neural stimulation system 6700 to be used with different ear geometries. The portion of the electrode skeleton 6746 that forms the second branch 6742 can be configured to be coupled to an ear bud 6748. For example, the second branch 6742 can be configured to mate with off-the-shelf compression molded ear bud covers. The portion of the electrode skeleton 6746 that forms the second branch 6742 can also define at least one channel 6750 configured to allow airflow between the ear canal and external to the device. As such, the channel 6750 can form a sound passthrough since the air flow allows the sound to move into the ear canal.
The extension 6704 can include an overmold 6752 that covers at least a portion of the first branch 6740 and the common region 6744. The overmold 6752 can be a flexible material, such as an elastomeric urethane or other suitable polymeric material or other type of material. As such, the overmold 6752 gives the extension 6704 compliance and flexibility, which can make the neural stimulation system 6700 more conformable to wear and allows the extension 6704 to conform to many ear geometries. The thickness of the overmold 6752 can be greater than 1 mm to maximize user comfort and manufacturability. In an example, forming the overmold 6752 from urethane will facilitate bonding the overmold 6752 to plastic and/or metal components of the extension 6704 thereby eliminating gaps in the extension 6704 that may complicate cleaning and sacrifice comfort.
In an embodiment, the neural stimulation device 6700 can include a plurality of electrodes, such as a first electrode 6706a, a second electrode 6706b, a third electrode 6706c, and a fourth electrode 6706d. It is noted that the neural stimulation device 6700 can include more or fewer electrodes. In the illustrated embodiment, the first, second, third, and fourth electrodes 6706a, 6706b, 6706c, 6706d are configured to contact the concha of the ear. For example, the first and second electrodes 6706a, 6706b can be configured to contact the cymba of the ear and the third and fourth electrode 6706c, 6706d can be configured to contact the cavum of the ear. Such an configuration allows the neural stimulation system 6700 to treat symptoms of mood disorders (e.g., stress, depression, and/or anxiety) or headaches. For example, such a configuration allow the first, second, third, and fourth electrodes 6706a, 6706b, 6706c, 6706d to apply controlled current pulses to the cymba and the cavum of the ear with the intent of stimulating the auricular branch of the vagus nerve.
In an example, the first and second electrodes 6706a, 6706b and/or the third and fourth electrodes 6706c, 6706d exhibit a center-to-center spacing, when the neural stimulation system 6700 is not attached to an ear, that is about 4 mm to about 6 mm, about 5 mm to about 7 mm, about 6 mm to about 8 mm, about 7 mm to about 9 mm, about 8 mm to about 10 mm about, 9 mm to about 11 mm, or about 10 mm to about 12 mm. In such an example, the first and second electrodes 6706a, 6706b can target the cymba of the ear and the third and fourth electrodes 6706c, 6706d can target the cavum of the ear.
In an example, the electrode 6706 is gold plated. In an example, the electrode 6706 exhibits a diameter that is about 1 mm to about 3 mm, about 2 mm to about 4 mm, about 3 mm to about 5 mm, about 4 mm to about 6 mm, about 5 mm to about 7 mm, about 6 mm to about 8 mm, about 7 mm to about 9 mm, or about 8 mm to about 67 cm. In an example, the electrode 6706 can exhibit a generally convex surface which can better ensure contact with the ear than an electrode exhibiting a planar surface. In an example, the electrode 6706 can be configured to be attached to the electrode skeleton 6746 using any suitable method, such as snapping.
In an embodiment, the neural stimulation system 6700 can be configured to be used in an ear having an auricle length of about 59 mm to about 63 mm, a conchal length of about 26 to about 28 mm, and a conchal width of about 19 mm to about 20 mm. In such an example, at least one of the center-to-center spacing of the first and second electrodes 6706a, 6706b and the center-to-center spacing of the third and fourth electrodes 6706c, 6706d can be about 8 mm, the diameter of the first, second, third, and fourth electrodes 6706a, 6706b, 6706c, 6706d can be about 4 mm, the neural stimulation device 6700 can weigh about 20 g, or the dimensions of the main body 6702 can be about 17 mm×27 mm×9.25 mm.
The battery charger 6800 includes a housing 6802. The housing 6802 can include a bottom portion 6804, a top portion 6806, and a hinge 6808 connecting the bottom portion 6804 and the top portion 6806 together. The hinge 6808 allows the top portion 6806 to move relative to the bottom portion 6804 thereby allowing the battery charger 6800 to switch between a closed configuration (
The battery charger 6800 is configured to charge a neural stimulation system. In an embodiment, the charger 6800 can also serve as a carrying case for the neural stimulation system. In such an embodiment, the battery charger 6800 can include a battery 6810 that allows the battery charger 6800 to charge a battery of the neural stimulation system while the battery charger 6800 holds the neural stimulation therein. In an example, the battery 6810 is a rechargeable battery. In such an example, the housing 6802 can define a charging portion 6811 that is configured to electrically couple the battery to an external electrical source.
The battery charger 6800 can include a lower carrier 6812. The lower carrier 6812 is configured to be disposed in the bottom portion 6804 of the housing 6802. The lower carrier 6812 includes at least one of the battery 6810, a circuit board 6814 configured to control one or more components of the battery charger 6800, a support member 6816, electrical contacts 6818, or at least one magnet 6820.
The support member 6816 can define at least one lower recess 6824 that is configured to have the neural stimulation system disposed therein. The support member 6816 can define one or more holes (obscured) therein that are configured to receive the electrical contacts 6818. The electrical contacts 6818 can be configured to mate with the charger contacts of the neural stimulation system. As such, the electrical contacts 6818 allow the battery charger 6800 to charge the neural stimulation system while the neural stimulation system is disposed in the lower recess 6824. In an example, the lower recess 6824 can exhibit a shape such that the neural stimulation system can only be disposed in the lower recess 6824 when the neural stimulation system exhibits a specific alignment which can facilitate contacting the electrical contacts 6818 against the charger contacts of the neural stimulation system. In an example, the support member 6816 can include magnets 6820 that are configured to pull the neural stimulation system against the electrical contacts 6818 and/or secure the neural stimulation system in the lower recess 6824.
The support member 6816 can define a secondary recess 6828 that is configured to receive and hold a wetting sponge 6830. The wetting sponge 6830 can include a conductive fluid therein. The wetting sponge 6830 can be configured to moisten the at least one electrode of the neural stimulation system with the conductive fluid prior to use which can improve an electrical connection between the electrode and an ear.
In an embodiment, the battery charger 6800 can include at least one indicator, such as a first indicator 6832 on the lower carrier 6812 and/or a second indicator 6834 on the bottom portion 6804 of the housing 6802. In such an embodiment, the circuit board 6814 can include at least one LED 6822, such as a first LED 6822a that corresponds to the first indicator 6832 and a second LED 6822b that corresponds to the second indicator 6832. In an example, the LED 6822 (e.g., at least one of the first or second LED 6822a, 6822b) directly contacts the first indicator 6832 and/or the second indicator 6834. In an example, the LED 6822 (e.g., at least one of the first or second LED 6822a, 6822b) is spaced from the first indicator 6832 and/or the second indicator 6834. In such an example, the battery charger 6800 can include a light pipe 6835 extending from the LED 6822 to the first and/or second indicator 6832, 6834. The light pipe 6835 can be configured to transmit the light emitted from the LED 6822 to the first and/or second indicator 6832, 6834. In an embodiment, the first and second indicators 6832, 6834 are configured to indicate different information. For example, the first indicator 6832 is configured to indicate a charge status of the neural stimulation system and the second indicator 6834 is configured to indicate a charge status of the battery 6810.
The battery charger 6800 can include an upper carrier 6836. The upper carrier 6836 is configured to be disposed in the upper portion 6806 of the housing 6802. In an example, the upper carrier 6836 can define at least one upper recess 6838 that is configured to at least partially receive the neural stimulation system. In an example, the upper carrier 6836 is configured to apply mechanical compression on the top of the neural stimulation system thereby facilitating contact between the electrical contacts 6818 and the charger contacts of the neural stimulation system. In an example, the upper carrier 6836 is configured to prevent evaporation of the fluid of the wetting sponge 6830.
In an embodiment, the battery charger 6800 includes a mechanism that is configured to maintain the bottom portion 6804 and the top portion 6806 of the housing 6802 in a closed configuration. In an example, the lower carrier 6812 can include a first magnet 6840 and the upper carrier 6836 can include a second magnet 6842. The first and second magnet 6840, 6842 can be positioned in the housing 6802 such that the first and second magnets 6840, 6842 are magnetically coupled together when the battery charger 680 is in a closed configuration thereby maintaining the battery charger 6800 in the closed configuration. In an example, the housing 6802 can include a latch or other suitable mechanism for closing the housing 6802.
The herein described subject matter sometimes illustrates different components contained within, or connected with, different other components. It is to be understood that such depicted architectures are merely exemplary, and that in fact many other architectures may be implemented which achieve the same functionality. In a conceptual sense, any arrangement of components to achieve the same functionality is effectively “associated” such that the desired functionality is achieved. Hence, any two components herein combined to achieve a particular functionality can be seen as “associated with” each other such that the desired functionality is achieved, irrespective of architectures or intermedial components. Likewise, any two components so associated can also be viewed as being “operably connected”, or “operably coupled,” to each other to achieve the desired functionality, and any two components capable of being so associated can also be viewed as being “operably couplable,” to each other to achieve the desired functionality. Specific examples of operably couplable include but are not limited to physically mateable and/or physically interacting components, and/or wirelessly interactable, and/or wirelessly interacting components, and/or logically interacting, and/or logically interactable components.
In some instances, one or more components may be referred to herein as “configured to,” “configured by,” “configurable to,” “operable/operative to,” “adapted/adaptable,” “able to,” “conformable/conformed to,” etc. Those skilled in the art will recognize that such terms (e.g., “configured to”) generally encompass active-state components and/or inactive-state components and/or standby-state components, unless context requires otherwise.
A computing device, as described herein, may include circuitry and other hardware components, provided, for example in the form of a custom board installed in the case of the computing device during or after manufacture, or in a separate package that may be operably connected to the computing device via one or more wired and/or wireless connection. Unless context dictates otherwise, as used herein, the term computing device is intended to encompass systems including circuitry and other hardware components packaged with the computing device and circuitry and other hardware components packaged separately but used in combination with the computing device.
While particular aspects of the present subject matter described herein have been shown and described, it will be apparent to those skilled in the art that, based upon the teachings herein, changes and modifications may be made without departing from the subject matter described herein and its broader aspects and, therefore, the appended claims are to encompass within their scope all such changes and modifications as are within the true spirit and scope of the subject matter described herein. It will be understood by those within the art that, in general, terms used herein, and especially in the appended claims (e.g., bodies of the appended claims) are generally intended as “open” terms (e.g., the term “including” should be interpreted as “including but not limited to,” the term “having” should be interpreted as “having at least,” the term “includes” should be interpreted as “includes but is not limited to,” etc.). It will be further understood by those within the art that if a specific number of an introduced claim recitation is intended, such an intent will be explicitly recited in the claim, and in the absence of such recitation no such intent is present. For example, as an aid to understanding, the following appended claims may contain usage of the introductory phrases “at least one” and “one or more” to introduce claim recitations. However, the use of such phrases should not be construed to imply that the introduction of a claim recitation by the indefinite articles “a” or “an” limits any particular claim containing such introduced claim recitation to claims containing only one such recitation, even when the same claim includes the introductory phrases “one or more” or “at least one” and indefinite articles such as “a” or “an” (e.g., “a” and/or “an” should typically be interpreted to mean “at least one” or “one or more”); the same holds true for the use of definite articles used to introduce claim recitations. In addition, even if a specific number of an introduced claim recitation is explicitly recited, those skilled in the art will recognize that such recitation should typically be interpreted to mean at least the recited number (e.g., the bare recitation of “two recitations,” without other modifiers, typically means at least two recitations, or two or more recitations). Furthermore, in those instances where a convention analogous to “at least one of A, B, and C, etc.” is used, in general such a construction is intended in the sense one having skill in the art would understand the convention (e.g., “ a system having at least one of A, B, and C” would include but not be limited to systems that have A alone, B alone, C alone, A and B together, A and C together, B and C together, and/or A, B, and C together, etc.). In those instances where a convention analogous to “at least one of A, B, or C, etc.” is used, in general such a construction is intended in the sense one having skill in the art would understand the convention (e.g., “ a system having at least one of A, B, or C” would include but not be limited to systems that have A alone, B alone, C alone, A and B together, A and C together, B and C together, and/or A, B, and C together, etc.). It will be further understood by those within the art that typically a disjunctive word and/or phrase presenting two or more alternative terms, whether in the description, claims, or drawings, should be understood to contemplate the possibilities of including one of the terms, either of the terms, or both terms unless context dictates otherwise. For example, the phrase “A or B” will be typically understood to include the possibilities of “A” or “B” or “A and B.”
With respect to the appended claims, those skilled in the art will appreciate that recited operations therein may generally be performed in any order. Also, although various operational flows are presented in a sequence(s), it should be understood that the various operations may be performed in other orders than those which are illustrated, or may be performed concurrently. Examples of such alternate orderings may include overlapping, interleaved, interrupted, reordered, incremental, preparatory, supplemental, simultaneous, reverse, or other variant orderings, unless context dictates otherwise. Furthermore, terms like “responsive to,” “related to,” or other past-tense adjectives are generally not intended to exclude such variants, unless context dictates otherwise.
While various aspects and embodiments have been disclosed herein, other aspects and embodiments will be apparent to those skilled in the art. The various aspects and embodiments disclosed herein are for purposes of illustration and are not intended to be limiting, with the true scope and spirit being indicated by the following claims.
If an Application Data Sheet (ADS) has been filed on the filing date of this application, it is incorporated by reference herein. Any applications claimed on the ADS for priority under 35 U.S.C. §§ 119, 120, 121, or 365(c), and any and all parent, grandparent, great-grandparent, etc. applications of such applications, are also incorporated by reference, including any priority claims made in those applications and any material incorporated by reference, to the extent such subject matter is not inconsistent herewith. The present application claims the benefit of the earliest available effective filing date(s) from the following listed application(s) (the “Priority Applications”), if any, listed below (e.g., claims earliest available priority dates for other than provisional patent applications or claims benefits under 35 USC § 119(e) for provisional patent applications, for any and all parent, grandparent, great-grandparent, etc. applications of the Priority Application(s)). The present application constitutes a continuation-in-part of U.S. patent application Ser. No. 15/996,621, entitled CONTROLLING EAR STIMULATION IN RESPONSE TO ELECTRICAL CONTACT SENSING, naming ELEANOR V. GOODALL, RODERICK A. HYDE; MURIEL Y. ISHIKAWA; JORDIN T. KARE; MELANIE K. KITZAN; ERIC C. LEUTHARDT; MARK A. MALAMUD; STEPHEN L. MALASKA; NATHAN P. MYHRVOLD; BRITTANY SCHEID; KATHERINE E. SHARADIN; ELIZABETH A. SWEENEY; CLARENCE T. TEGREENE; CHARLES WHITMER; LOWELL L. WOOD, JR.; AND VICTORIA Y. H. WOOD as inventors, filed 4 Jun. 2018 with attorney docket no. 1213-004-001-CP3C01, which is currently co-pending or is an application of which a currently co-pending application is entitled to the benefit of the filing date, which is a continuation of U.S. patent application Ser. No. 15/340,145, entitled CONTROLLING EAR STIMULATION IN RESPONSE TO ELECTRICAL CONTACT SENSING, naming ELEANOR V. GOODALL, RODERICK A. HYDE; MURIEL Y. ISHIKAWA; JORDIN T. KARE; MELANIE K. KITZAN; ERIC C. LEUTHARDT; MARK A. MALAMUD; STEPHEN L. MALASKA; NATHAN P. MYHRVOLD; BRITTANY SCHEID; KATHERINE E. SHARADIN; ELIZABETH A. SWEENEY; CLARENCE T. TEGREENE; CHARLES WHITMER; LOWELL L. WOOD, JR.; AND VICTORIA Y. H. WOOD as inventors, filed 1 Nov. 2016 with attorney docket no. 1213-004-001-CIP003, which is currently co-pending or is an application of which a currently co-pending application is entitled to the benefit of the filing date, now U.S. Pat. No. 9,987,489 granted 5 Jun. 2018, which is a continuation-in-part of U.S. patent application Ser. No. 14/670,504, entitled EAR STIMULATION WITH NEURAL FEEDBACK SENSING, naming RODERICK A. HYDE, MURIEL Y. ISHIKAWA, JORDIN T. KARE, ERIC C. LEUTHARDT, MARK A. MALAMUD, STEPHEN L. MALASKA, NATHAN P. MYHRVOLD, ELIZABETH A. SWEENEY, CLARENCE T. TEGREENE, CHARLES WHITMER, LOWELL L. WOOD, JR., AND VICTORIA Y. H. WOOD, as inventors, filed 27 Mar. 2015 with attorney docket no. 1213-004-001-000000, which is currently co-pending or is an application of which a currently co-pending application is entitled to the benefit of the filing date, now U.S. Pat. No. 10,039,928 granted 7 Aug. 2018; a continuation-in-part of U.S. patent application Ser. No. 14/670,537, entitled VIBRATORY EAR STIMULATION SYSTEM AND METHOD, naming RODERICK A. HYDE, MURIEL Y. ISHIKAWA, JORDIN T. KARE, ERIC C. LEUTHARDT, MARK A. MALAMUD, STEPHEN L. MALASKA, NATHAN P. MYHRVOLD, ELIZABETH A. SWEENEY, CLARENCE T. TEGREENE, CHARLES WHITMER, LOWELL L. WOOD, JR., AND VICTORIA Y. H. WOOD, as inventors, filed 27 Mar. 2015 with attorney docket no. 1213-004-002-000000, which is currently co-pending or is an application of which a currently co-pending application is entitled to the benefit of the filing date; a continuation-in-part of U.S. patent application Ser. No. 14/670,560, entitled METHOD AND SYSTEM FOR CONTROLLING EAR STIMULATION, naming RODERICK A. HYDE, MURIEL Y. ISHIKAWA, JORDIN T. KARE, ERIC C. LEUTHARDT, MARK A. MALAMUD, STEPHEN L. MALASKA, NATHAN P. MYHRVOLD, ELIZABETH A. SWEENEY, CLARENCE T. TEGREENE, CHARLES WHITMER, LOWELL L. WOOD, JR., AND VICTORIA Y. H. WOOD, as inventors, filed 27 Mar. 2015 with attorney docket no. 1213-004-003-000000, which is currently co-pending or is an application of which a currently co-pending application is entitled to the benefit of the filing date; a continuation-in-part of U.S. patent application Ser. No. 14/670,582, entitled USER INTERFACE METHOD AND SYSTEM FOR EAR STIMULATION, naming RODERICK A. HYDE, MURIEL Y. ISHIKAWA, JORDIN T. KARE, ERIC C. LEUTHARDT, MARK A. MALAMUD, STEPHEN L. MALASKA, NATHAN P. MYHRVOLD, ELIZABETH A. SWEENEY, CLARENCE T. TEGREENE, CHARLES WHITMER, LOWELL L. WOOD, JR., AND VICTORIA Y. H. WOOD, as inventors, filed 27 Mar. 2015 with attorney docket no. 1213-004-004-000000, which is currently co-pending or is an application of which a currently co-pending application is entitled to the benefit of the filing date; a continuation-in-part of U.S. patent application Ser. No. 14/670,620, entitled NEURAL STIMULATION METHOD AND SYSTEM WITH AUDIO OUTPUT, naming RODERICK A. HYDE, MURIEL Y. ISHIKAWA, JORDIN T. KARE, ERIC C. LEUTHARDT, MARK A. MALAMUD, STEPHEN L. MALASKA, NATHAN P. MYHRVOLD, ELIZABETH A. SWEENEY, CLARENCE T. TEGREENE, CHARLES WHITMER, LOWELL L. WOOD, JR., AND VICTORIA Y. H. WOOD, as inventors, filed 27 Mar. 2015 with attorney docket no. 1213-004-005-000000, which is currently co-pending or is an application of which a currently co-pending application is entitled to the benefit of the filing date; a continuation-in-part of U.S. patent application Ser. No. 14/670,656, entitled RECOMMENDATION METHOD AND SYSTEM FOR TREATMENTS INCLUDING EAR STIMULATION, naming RODERICK A. HYDE, MURIEL Y. ISHIKAWA, JORDIN T. KARE, ERIC C. LEUTHARDT, MARK A. MALAMUD, STEPHEN L. MALASKA, NATHAN P. MYHRVOLD, ELIZABETH A. SWEENEY, CLARENCE T. TEGREENE, CHARLES WHITMER, LOWELL L. WOOD, JR., AND VICTORIA Y. H. WOOD, as inventors, filed 27 Mar. 2015 with attorney docket no. 1213-004-006-000000, which is currently co-pending or is an application of which a currently co-pending application is entitled to the benefit of the filing date; a continuation-in-part of U.S. patent application Ser. No. 15/291,358, entitled NERVE STIMULATION SYSTEM AND RELATED CONTROLLER, naming RODERICK A. HYDE, MURIEL Y. ISHIKAWA, JORDIN T. KARE, ERIC C. LEUTHARDT, MARK A. MALAMUD, STEPHEN L. MALASKA, NATHAN P. MYHRVOLD, BRITTANY SCHEID, ELIZABETH A. SWEENEY, CLARENCE T. TEGREENE, CHARLES WHITMER, LOWELL L. WOOD, JR., AND VICTORIA Y. H. WOOD, as inventors, filed 12 Oct. 2016 with attorney docket no. 1213-004-001-CIP001, which is currently co-pending or is an application of which a currently co-pending application is entitled to the benefit of the filing date; a continuation-in-part of U.S. patent application Ser. No. 15/340,058, entitled CONTROLLING EAR STIMULATION IN RESPONSE TO IMAGE ANALYSIS, naming ELEANOR V. GOODALL, RODERICK A. HYDE, MURIEL Y. ISHIKAWA, JORDIN T. KARE, MELANIE K. KITZAN, ERIC C. LEUTHARDT, MARK A. MALAMUD, STEPHEN L. MALASKA, NATHAN P. MYHRVOLD, BRITTANY SCHEID, KATHERINE E. SHARADIN, ELIZABETH A. SWEENEY, CLARENCE T. TEGREENE, CHARLES WHITMER, LOWELL L. WOOD, JR., AND VICTORIA Y. H. WOOD, as inventors, filed 1 Nov. 2016 with attorney docket no. 1213-004-001-CIP002, which is currently co-pending or is an application of which a currently co-pending application is entitled to the benefit of the filing date; a continuation-in-part of U.S. patent application Ser. No. 15/340,217, entitled MULTI-FACTOR CONTROL OF EAR STIMULATION, naming ELEANOR V. GOODALL, RODERICK A. HYDE, MURIEL Y. ISHIKAWA, JORDIN T. KARE, MELANIE K. KITZAN, ERIC C. LEUTHARDT, MARK A. MALAMUD, STEPHEN L. MALASKA, NATHAN P. MYHRVOLD, BRITTANY SCHEID, KATHERINE E. SHARADIN, ELIZABETH A. SWEENEY, CLARENCE T. TEGREENE, CHARLES WHITMER, LOWELL L. WOOD, JR., AND VICTORIA Y. H. WOOD, as inventors, filed 1 Nov. 2016 with attorney docket no. 1213-004-001-CIP004, which is currently co-pending or is an application of which a currently co-pending application is entitled to the benefit of the filing date; and is a continuation-in-part of U.S. patent application Ser. No. 15/673,087, entitled NERVE STIMULATION SYSTEM, SUBSYSTEM, HEADSET, AND EARPIECE, naming ELEANOR V. GOODALL, RODERICK A. HYDE, MURIEL Y. ISHIKAWA, JORDIN T. KARE, ERIC C. LEUTHARDT, MARK A. MALAMUD, STEPHEN L. MALASKA, NATHAN P. MYHRVOLD, TIM F. RAMSEY, BRITTANY SCHEID, KATHERINE E. SHARADIN, ELIZABETH A. SWEENEY, CLARENCE T. TEGREENE, CHARLES WHITMER, LOWELL L. WOOD, JR., AND VICTORIA Y. H. WOOD, as inventors, filed 9 Aug. 2017 with attorney docket no. 1213-004-001-CP1CP1, which is currently co-pending or is an application of which a currently co-pending application is entitled to the benefit of the filing date. The present application claims benefit of priority of U.S. Provisional Patent Application No. 62/648,759, entitled MULTI-FACTOR CONTROL OF EAR STIMULATION, naming KATHERINE E. SHARADIN as inventor, filed 27 Mar. 2018, with attorney docket no. 0917-004-001-PR0001, which was filed within the twelve months preceding the filing date of the present application or is an application of which a currently co-pending priority application is entitled to the benefit of the filing date. If the listings of applications provided above are inconsistent with the listings provided via an ADS, it is the intent of the Applicant to claim priority to each application that appears in the Domestic Benefit/National Stage Information section of the ADS and to each application that appears in the Priority Applications section of this application. All subject matter of the Priority Applications and of any and all applications related to the Priority Applications by priority claims (directly or indirectly), including any priority claims made and subject matter incorporated by reference therein as of the filing date of the instant application, is incorporated herein by reference to the extent such subject matter is not inconsistent herewith.
| Number | Date | Country | |
|---|---|---|---|
| 62648759 | Mar 2018 | US |
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| Parent | 15340145 | Nov 2016 | US |
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| Parent | 15673087 | Aug 2017 | US |
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| Parent | 15291358 | Oct 2016 | US |
| Child | 15340058 | US | |
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| Child | 14670656 | US | |
| Parent | 14670582 | Mar 2015 | US |
| Child | 14670620 | US | |
| Parent | 14670560 | Mar 2015 | US |
| Child | 14670582 | US | |
| Parent | 14670537 | Mar 2015 | US |
| Child | 14670560 | US |
