INTER-DEVICE TECHNIQUES FOR ENHANCING SENSORY PROCESSING

Information

  • Patent Application
  • 20250018191
  • Publication Number
    20250018191
  • Date Filed
    July 12, 2024
    6 months ago
  • Date Published
    January 16, 2025
    15 days ago
Abstract
Devices and apparatuses for inter-device stimulation. A device includes a pair of electrodes. The pair of electrodes is electrically connected to a power source. The pair of electrodes is adapted to apply a current delivered from the power source to stimulate a vagus nerve of a subject. An interelectrode distance between the pair of electrodes is defined based on a predetermined height of a carotid triangle. The power source is communicatively connected to a controller. The controller is configured to send control signals in order to control the current delivered from the power source to the pair of electrodes in a continuous stimulation pattern.
Description
TECHNICAL FIELD

The present disclosure relates generally to enhancing sensory processing, and more specifically to enhancing sensory processing via vagus nerve stimulation.


BACKGROUND

Impaired sensory processing is linked to a variety of negative effects on life. Examples include withdrawal from social situations, increased risk of falls or other accidents, and inability to live independently. Seniors often face these challenges and more as sensory processing declines with age. Aging both deteriorates sensory receptors such as eyes and ears, and impairs the brain's ability to process signals received from those receptors (i.e., central sensory processing). The combined effects of sensory loss may cause anxiety, depression, and accelerated onset of dementia.


In addition to aging, other individuals may experience impaired sensory processing. Individuals with sensory processing disorders such as attention deficit hyper disorder (ADHD) and dyslexia have been shown to be more likely to have impaired sensory processing. Moreover, fatigue, inattention, and concussions can all impair sensory processing. Athletes and other active individuals can therefore also experience impaired sensory processing. Decreased sensory acuity is linked with increased risk of injury and poor performance at work, school, and recreational activities.


Existing solutions for treating sensory loss in seniors such as glasses and hearing aids address deterioration of receptors. However, other these solutions do not address other potential causes of impaired sensory processing. Additionally, these solutions face challenges in improving sensory processing for individuals who do not demonstrate deteriorated receptors. Other existing solutions may include chemical or other pharmaceutical stimulants which can help improve sensory processing but have side effects such as cardiac damage, insomnia, anxiety, loss of appetite, and addiction. Further, nootropics and supplements may fail to provide the benefits advertised at best, and be actively harmful to consumers at worst.


New solutions for improving sensory processing would therefore be desirable.


SUMMARY

A summary of several example embodiments of the disclosure follows. This summary is provided for the convenience of the reader to provide a basic understanding of such embodiments and does not wholly define the breadth of the disclosure. This summary is not an extensive overview of all contemplated embodiments, and is intended to neither identify key or critical elements of all embodiments nor to delineate the scope of any or all aspects. Its sole purpose is to present some concepts of one or more embodiments in a simplified form as a prelude to the more detailed description that is presented later. For convenience, the term “some embodiments” or “certain embodiments” may be used herein to refer to a single embodiment or multiple embodiments of the disclosure.


Certain embodiments disclosed herein include a device. The device comprises: a pair of electrodes, wherein the pair of electrodes is electrically connected to a power source, wherein the pair of electrodes is adapted to apply a current delivered from the power source to stimulate a vagus nerve of a subject, wherein an interelectrode distance between the pair of electrodes is defined based on a predetermined height of a carotid triangle, wherein the power source is communicatively connected to a controller, wherein the controller is configured to send control signals in order to control the current delivered from the power source to the pair of electrodes in a continuous stimulation pattern.


Certain embodiments disclosed herein include a stimulation apparatus. The stimulation apparatus comprises: a first device, the first device further comprising a pair of electrodes, wherein an interelectrode distance between the pair of electrodes is defined based on a predetermined height of a carotid triangle; and a second device, the second device further comprising a power source, wherein the pair of electrodes is electrically connected to the power source, wherein the pair of electrodes is adapted to apply a current delivered from the power source to stimulate a vagus nerve of a subject, wherein the power source is communicatively connected to a controller, wherein the controller is configured to send control signals in order to control the current delivered from the power source to the pair of electrodes in a continuous stimulation pattern.


Certain embodiments disclosed herein include one of the devices or apparatuses noted above or below, wherein the device is a first device, further comprising: the power source, wherein the controller is included in a second device, wherein the second device is communicatively connected to the first device.


Certain embodiments disclosed herein include one of the devices or apparatuses noted above or below, wherein the device is a first device, further comprising: the controller, wherein the power source is included in a second device, wherein the second device is electrically connected to the first device.


Certain embodiments disclosed herein include one of the devices or apparatuses noted above or below, wherein the device is a first device, wherein the power source and the controller are included in a second device, wherein the second device is electrically connected to the first device.


Certain embodiments disclosed herein include one of the devices or apparatuses noted above or below, further comprising: a microphone adapted to capture audio including background noise of an environment in which the device is deployed, wherein the controller is further configured to detect a stimulation trigger based on the background noise and to send the control signals when the stimulation trigger is detected.


Certain embodiments disclosed herein include one of the devices or apparatuses noted above or below, wherein the stimulation trigger is detected based on the background noise being above a predetermined threshold.


Certain embodiments disclosed herein include one of the devices or apparatuses noted above or below, wherein the controller is further configured to utilize speech sensing software to analyze the captured audio in order to detect a conversation between the subject and at least one other individual, wherein the stimulation trigger is detected based on the detected conversation.


Certain embodiments disclosed herein include one of the devices or apparatuses noted above or below, wherein the interelectrode distance is between 4 and 5 centimeters.


Certain embodiments disclosed herein include one of the devices or apparatuses noted above or below, wherein the interelectrode distance is 4 centimeters.


Certain embodiments disclosed herein include one of the devices or apparatuses noted above or below, wherein the continuous stimulation pattern utilizes a plurality of pulses, wherein each pulse is less than one millisecond in length.


Certain embodiments disclosed herein include one of the devices or apparatuses noted above or below, wherein the continuous stimulation pattern is a continuous biphasic stimulation pattern.


Certain embodiments disclosed herein include one of the devices or apparatuses noted above or below, wherein the continuous stimulation pattern includes energy pulses with a square biphasic waveform having two phases.


Certain embodiments disclosed herein include one of the devices or apparatuses noted above or below, wherein each of the two phases of the square biphasic waveform is 100 milliseconds in length.


Certain embodiments disclosed herein include one of the devices or apparatuses noted above or below, wherein the continuous stimulation pattern utilizes a plurality of pulses delivered at a frequency between 15 and 60 Hertz.


Certain embodiments disclosed herein include one of the devices or apparatuses noted above or below, wherein the plurality of pulses is delivered at a frequency of 30 Hertz.


Certain embodiments disclosed herein include one of the devices or apparatuses noted above or below, wherein the plurality of pulses is delivered at a frequency of 45 Hertz.


Certain embodiments disclosed herein include one of the devices or apparatuses noted above or below, wherein the continuous stimulation pattern includes a square biphasic waveform.


Certain embodiments disclosed herein include one of the devices or apparatuses noted above or below, wherein the continuous stimulation pattern includes an asymmetric biphasic waveform.


Certain embodiments disclosed herein include one of the devices or apparatuses noted above or below, wherein the controller is further configured to cause the current delivered from the power source to the pair of electrodes in the continuous stimulation pattern at a first current level and then to incrementally increase the current from the first current level to a second current level.


Certain embodiments disclosed herein include one of the devices or apparatuses noted above or below, wherein the first current level is 5 milliamps.


Certain embodiments disclosed herein include one of the devices or apparatuses noted above or below, wherein the second current level is between 7 and 12 milliamps.


Certain embodiments disclosed herein include one of the devices or apparatuses noted above or below, wherein the second current level is at most 60 milliamps.


Certain embodiments disclosed herein include one of the devices or apparatuses noted above or below, wherein the first device further comprises the controller.


Certain embodiments disclosed herein include one of the devices or apparatuses noted above or below, wherein the second device further comprises the controller.





BRIEF DESCRIPTION OF THE DRAWINGS

The subject matter disclosed herein is particularly pointed out and distinctly claimed in the claims at the conclusion of the specification. The foregoing and other objects, features, and advantages of the disclosed embodiments will be apparent from the following detailed description taken in conjunction with the accompanying drawings.



FIG. 1 is a diagram illustrating a device placed on a carotid triangle according to an embodiment.



FIG. 2 is mechanism of action diagram illustrating vagus nerve stimulation utilized to describe various disclosed embodiments.



FIG. 3 is a schematic diagram illustrating components of a device in accordance with various disclosed embodiments.



FIG. 4 is a diagram illustrating a dumbbell-shaped design of a device according to an embodiment.



FIG. 5 is a diagram illustrating a necklace-shaped design of a device according to an embodiment.



FIG. 6 is a wire diagram illustrating connections between terminals and electrodes according to an embodiment.



FIG. 7 is a diagram illustrating a bandage-shaped design of a device according to an embodiment.



FIG. 8 is a schematic diagram of electrical components in accordance with various disclosed embodiments.



FIG. 9 is a system diagram utilized to describe various disclosed embodiments.



FIG. 10 is a hardware architecture diagram utilized to describe various disclosed embodiments.



FIG. 11 is a top exploded view illustrating components of a device according to an embodiment.



FIG. 12 is a bottom exploded view illustrating components of a device according to an embodiment.



FIG. 13 is an assembled view of a device according to an embodiment.



FIG. 14 is an exploded view of a housing according to an embodiment.



FIG. 15 is an illustration of a device placed on a user.



FIG. 16 is a diagram illustrating a dual-member design of a device according to an embodiment.



FIG. 17 is a diagram illustrating flexibility of members of a device according to an embodiment.



FIG. 18 is a diagram illustrating a forked dual-member design of a device according to an embodiment.



FIG. 19 is an illustration of a dual-member device placed on a user.



FIG. 20 is a schematic diagram of a hardware layer of computing components of a device according to an embodiment.



FIG. 21 is a flowchart illustrating a method for vagus nerve stimulation according to an embodiment.



FIG. 22 is a diagram illustrating a device connected to a hearing aid via a wire according to an embodiment.



FIG. 23 is a diagram illustrating a device connected to a hearing aid wirelessly according to an embodiment.



FIG. 24 is a flowchart illustrating a method for stimulating based on background noise according to an embodiment.



FIG. 25 is a flowchart illustrating a method for triggering stimulation based on background noise according to an embodiment.





DETAILED DESCRIPTION

It has been identified that senses of a subject such as vision, hearing, and touch, are more accurate when the subject is attentive and alert. When highly attentive, the brain activates neural circuitry in ways that optimize how sensory information is encoded and processed. This optimized sensory processing removes noise and may increase the accuracy and detail of sensory information, which allows for more accurate perception. Accordingly, various disclosed embodiments allow a subject (e.g., a subject wearing a wearable device) to activate this neural circuitry on demand in order to enhance sensory acuity and reduce misperceptions.


In this regard, it has been identified that, after sensory information is encoded by receptors (e.g., eyes, ears, skin), the sensory information enters the brain as a pattern of neural activity encoded as a neural signal. This signal is then processed through multiple brain regions before it is perceived during sensory processing, which lets brain regions along this pathway such as, but not limited to, the thalamus, to influence how the world is perceived. Perceptual acuity is therefore dependent upon high-fidelity, accurate sensory processing. As thalamic processing is a biological process, suboptimal conditions (e.g., brain states, neurochemical levels) may introduce noise or dysfunction in neural circuits that degrades the sensory information processed, thereby resulting in degraded acuity of perceived sensory content.


It has further been identified, via testing on subjects such as rats, that steady activation of the locus coeruleus-norepinephrine (LC-NE) system can cause a steady increase in NE concentration in the thalamus that enables optimization of intrathalamic dynamics for more accurate and detailed sensory processing. It has been identified that such an NE-enhanced sensory processing state can translate to enhanced sensory acuity as evidenced by improved performance on sensory discrimination tests. Moreover, it is noted that the function of neuromodulatory systems are similar in humans and rodents such that it has been identified that the applications of these findings (including the various disclosed embodiments) may be applied to humans and potentially other animals as well.


On a related note, it has also been identified that the increased NE levels used to improve sensory processing alter the response properties of thalamic neurons encoding sensory information in a manner that reduces the influence of calcium t-channels (membrane channels in neurons that influence electrical potential and therefore spiking response) responsible for burst firing. It has been identified that burst firing, and influence of calcium t-channels, can impair the ability of neurons to accurately encode details of sensory stimuli such that the process of burst firing tends to decrease sensory acuity.


Further, it has been identified that direct activation of the LC may be dangerous in humans due to the LC's location deep in the brainstem near regions involved with regulation of the autonomic nervous system that controls critical involuntary functions. However, it has been identified that vagus nerve stimulation (VNS) can be utilized to activate the LC. The vagus nerve innervates the nucleus tractus solitarius and provides excitatory input. When VNS is applied, the nucleus of the solitary tract (NTS) is activated, which in turn innervates and activates the LC. Moreover, it has been further identified that certain patterns of VNS particularly demonstrate beneficial effects on sensory processing similar to that seen with LC stimulation such that these patterns may be leveraged, in accordance with various disclosed embodiments, in order to achieve activation of the LC-NE system to produce comparable or otherwise similar effects to direct activation of the LC, thereby allowing for utilizing LC activation to improve sensory processing while avoiding certain harmful effects of implants or energy targeted for direct LC activation.


In this regard, it has further been identified that certain VNS patterns may be utilized in order to provide a benefit to sensory processing, Some such stimulation patterns may include fully continuous electrical waveforms with no quiescent periods (e.g., continuous alternating current), and other such stimulation patterns may include transient stimulation events with quiescent intervals in between (e.g., pulsed stimulation with quiescent inter-pulse-intervals). Further, either type of those waveforms can be either delivered nonstop or can be delivered with a duty-cycle stimulation pattern (i.e., a stimulation pattern including multiple pulses or a continuous waveform) being repeatedly delivered for some time period (on cycle) and then not delivered for another time period (off cycle), with this cycle repeating continuously. Stimulation patterns can also be modulated over time by changing frequency or amplitude of current.


In this regard, it has been identified that stimulation patterns which have duty cycles that create quiescent periods greater than about 10 seconds tend to create a fluctuating influence on NE levels in the brain and, in turn, a fluctuating influence on sensory processing which may yield suboptimal results. It has further been identified that stimulation patterns which contain quiescent periods longer than about 100 milliseconds may result in a continuous sensation of electrical current at the skin. In at least some implementations, such a continuous sensation of electrical current may be desirable to avoid, for example, to avoid potential distractions caused by such stimulation. It has yet further been identified that a stimulation pattern with less than about 40 ms of quiescent time between stimulation pulses may result in desensitization of the skin within about 5 minutes of use, with some subjects experiencing desensitization within 1 minute and others experiencing desensitization up to 10 minutes after stimulation begins. This may allow for reducing any sensation at the interface site between the skin and the stimulating device producing the transcutaneous electrical field. Therefore, an uninterrupted tonic stimulation pattern may provide better results for at least some implementations. More specifically, an uninterrupted tonic stimulation pattern may mimic the continuous tonic activation of the LC-NE system that occurs naturally during increased attention or arousal, and may therefore improve effects on sensory perception.


It has also been identified that the LC-NE system may modulate sensory processing of visual and auditory modalities in a similar manner. More specifically, it has been identified that increased attention and NE levels correlated with reduced bursting activity in neurons processing visual and auditory information (e.g., in thalamus, cortex, etc.). Accordingly, it has been identified that increases in forebrain NE concentration, and suppression of calcium t-channel bursting activity, may be utilized to enhance thalamic information processing and transmission. It has therefore been determined that the NE system may be able to optimize sensory perception.


To this end, various disclosed embodiments leverage these discoveries regarding the effects of LC-NE activation on sensory processing and the use of VNS to activate the LC in a manner which improves safety as compared to, for example, direct LC stimulation. At least some disclosed embodiments utilize patterns of VNS stimulation which have been discovered to yield particularly optimal sensory processing improvements. In particular, various disclosed embodiments utilize an uninterrupted tonic pattern of VNS which has been identified to allow for enhanced sensory processing.


In particular, various disclosed embodiments may use or include an externally worn, transcutaneous cervical vagus nerve stimulation (nVNS) patch. Such a patch may be conveniently removable in order to allow users to utilize the patch during specific times, for example, when participating in sports, when operating in dangerous conditions, or otherwise when it is desirable to improve sensory processing. This patch may also, in accordance with various disclosed embodiments, be designed to be fully noninvasive and to deliver electrical current to the vagus nerve through the skin via flat electrodes which may rest above where the vagus nerve runs through the neck. This patch may also have an adhesive layer which holds the device and electrodes in contact with the skin. Accordingly, the disclosed nVNS techniques and devices allow for providing a safe and effective means of inducing neuromodulation which can be activated and deactivated on-demand.


The disclosed embodiments may therefore be utilized in different implementations which may require sensory processing improvements or otherwise for which sensory processing improvements may be desirable. In particular, various disclosed embodiments may aid individuals with neurodegenerative disorders which affect sensory processing such as, but not limited to, Alzheimer's disease, Parkinson's, age-related sensory loss, shift-work syndrome, insomnia, and the like. More specifically, various disclosed embodiments may be utilized in order to treat patients with these impairments. Additionally, individuals with disorders such as ADHD and dyslexia may be treated in order to mitigate the effects of these disorders on sensory processing.


In addition to treating individuals having certain disorders, various disclosed embodiments may have applicability in contexts such as sports, gaming, or other contexts where enhanced sensory processing might be desirable including, but not limited to, students, artists, individuals enjoying sensorial content, military, and the like. As a non-limiting example, athletes playing a physical sport or e-sport may benefit from improved sensory processing which may allow them to more accurately perceive visual, auditory, and tactile feedback. This, in turn, may reduce misperceptions, miscommunications, clumsy hands, combinations thereof, and the like, that could impair performance. Likewise, individuals performing tasks which are inherently dangerous and require sharp sensory processing (as misperceptions may result in costly human error) may benefit from various disclosed embodiments.



FIG. 1 is a diagram 100 illustrating a device placed on a carotid triangle according to an embodiment. The diagram 100 illustrates a device 110 in the form of a triangular patch which may be disposed on a neck 120 of a user in accordance with various disclosed embodiments. More specifically, in an embodiment, the device 110 is aligned above the carotid artery of the neck because the vagus nerve runs adjacent and parallel with the carotid artery underneath the carotid triangle of the neck. In accordance with various disclosed embodiments, the device 110 is disposed on a carotid triangle of the neck 120 of the user. In the embodiment depicted in FIG. 1, the device 110 may be placed on a user non-invasively, i.e., without needing to pierce the skin of the neck 120 of the user or otherwise implanting the device 110 underneath the skin of the neck 120. Thus, the disclosed embodiments may allow for improving sensory processing non-invasively.



FIG. 2 is a mechanism of action diagram 200 illustrating vagus nerve stimulation utilized to describe various disclosed embodiments. The diagram 200 illustrates certain aspects in accordance with various disclosed embodiments. More specifically, the diagram 200 illustrates conversion 210 of sound into a neural signal by the ear, which is then processed by the brain before perception occurs. The diagram 200 also illustrates stimulation 220 of a vagus nerve 221 via a device 222 and demonstrates how stimulation of the vagus nerve 221 causes norepinephrine levels to increase in regions of a brain 223 which process auditory information. The device 222 may be a device configured in accordance with one or more disclosed embodiments. Further illustrated are effects 230 of the resulting increased norepinephrine levels resulting in enhanced sensory processing, which in turn results in a clearer perception of the sound.


In accordance with at least some disclosed embodiments, stimulation may be targeted at a section of the vagus nerve located under the carotid triangle. To this end, in an embodiment, the device 222 is disposed on a left side of the neck. As discussed further below with respect to FIG. 3, the device 222 may include a pair of electrodes (e.g., hydrogel electrodes) to facilitate delivery of electric energy targeting the vagus nerve 221 as it runs under the location of the carotid triangle. In at least some embodiments, the device 222 does not extend above the neck onto the jaw.


In accordance with various disclosed embodiments, the device 222 utilizes directed energy targeted at certain tissues (e.g., neural, organ, muscles, etc.). The directed energy may be delivered with specific patterns (e.g., waveform, intensity, frequency, etc.) in order to evoke certain changes in neural activity, behavior, and cognition. To this end, the device 222 may be realized as, for example but not limited to, a neural stimulation patch adapted to activate neural circuitry (e.g., the norepinephrine system via stimulation of the vagus nerve 221) that causes enhancement of central sensory processing. Specifically, the enhanced central sensory processing may improve acuity of any of vision, hearing, touch, and the like. In at least some implementations, the enhanced sensory processing may be realized instantly after stimulation begins and may continue until the device 222 is removed. As noted above, vagus nerve stimulation may allow for enhancing sensory processing while minimizing or avoiding side effects.


In at least some embodiments, the device 222 may be realized as or using an adhesive patch. In some implementations, the entire patch (i.e., the entire device 222) may be disposable. In other implementations, some components of the device 222 (e.g., a microchip, not shown in FIG. 2) are durable and components such as electrodes and batteries are replaceable. In an embodiment, the device 222 has dimensions between 5to 6 centimeters tall, 2 to 3 centimeters wide, and thickness less than 0.5 centimeters.



FIG. 3 is a schematic diagram illustrating components of a device 300 in accordance with various disclosed embodiments.


As depicted in FIG. 3, an outer edge 310 of the device 300 may be designed with a shape that may vary on the use case. The example shape of the outer edge 310 depicted in FIG. 3 may allow for minimizing the size of the device 300, but other shapes may be equally utilized in accordance with various disclosed embodiments. For example, in some embodiments, the device 300 may be triangular as depicted in FIG. 1. Such a triangular shape may aid a user in correctly aligning placement of the device 300 with respect to a carotid triangle. The outer edge 310 may be, but is not limited to, around 0.5 centimeters thick.


The device 300 includes a pair of electrodes 320-1 and 320-2. In an embodiment, each of the electrodes 320-1 and 320-2 is a gel electrode. In a further embodiment, each electrode 320-1 and 320-2 has a diameter of 2 centimeters. In yet a further embodiment, a distance between center points of the electrodes 320-1 and 320-2 is 4 centimeters. In another embodiment, the distance between such center points is between 4 and 5 centimeters.


In this regard, it is noted that optimal interelectrode distance in at least some embodiments is based on the height of the carotid triangle of a given user. More specifically, electrodes which are placed outside of the carotid triangle may face challenges in optimally penetrating the vagus nerve with current due to increased muscle between the skin and the target nerve at locations outside of the carotid triangle. It has been identified that a distance between 4 and 5 centimeters between electrodes may allow for optimizing penetration of current in accordance with various disclosed embodiments. Moreover the shape of the electrodes may be selected in order to maximize surface area, distance between center points, or both.


The electrodes 320-1 and 320-2 are connected via respective wires 330-1 and 330-2 to a circuit board 340 such as, but not limited to, a printed circuit board. As depicted in FIG. 3, the circuit board 340 is shaped in order to partially surround a battery 350, although other shapes may be equally utilized in at least some other embodiments. In some implementations, the circuit board 340 and the battery 350 may be stacked on top of each other. In an embodiment, the circuit board has a surface area of around 2 square centimeters. In a further embodiment, the circuit board is 1 millimeter thick. In yet a further embodiment, the circuit board is opaque. In yet a further embodiment, the circuit board is transparent. In yet a further embodiment, the circuit board is flexible. In some embodiments, the electrodes 320-1 and 320-2 are surrounded by an edge 360 of the device 300 which extends at least 1 centimeter beyond the outer boundary of the electrodes 320-1 and 320-2.


In this regard, it has been identified that maintaining a minimal surface area for the electrodes may be utilized to ensure that the current density during stimulation does not increase to a level where discomfort or injury would occur. It has further been identified that a surface area of around at least 2 square centimeters allows for delivering a sufficient current to enhance sensory processing via vagus nerve stimulation while minimizing or avoiding any discomfort or injury. In other embodiments, electrodes with larger surface areas may be utilized. In that regard, it is noted that larger electrodes may allow for minimizing cutaneous pain due to reduced current density at skin, and may therefore be particularly suitable for deeper nerve stimulation and/or constant recruitment.


It has further been identified that conductive hydrogel electrode coatings may be utilized to improve the performance of bionic devices, which may utilize lower amounts of energy than certain metal electrodes as well as which may exhibit better biocompatibility and adhesive properties. Thus, in at least some embodiments, hydrogel electrodes are utilized. In other embodiments, other materials with suitable conductivity to provide vagus nerve stimulation in order to realize enhanced sensory processing may be utilized (e.g., carbon/rubber, silver/silver chloride, stainless steel, nickel, gold, etc.).


The wires 330-1 and 330-2 may be or may include, but are not limited to, conductive wires, traces, and the like. In some embodiments, wires may not be utilized for components which are connected directly (e.g., via solder contact points). Examples of such direct connections are depicted in FIGS. 4 and 5, where electrodes are connected directly to circuit boards and batteries, respectively.


The battery 350 is connected to the circuit board 340, either via direct contact or via a wire (not shown in FIG. 3). To this end, the battery 350 may be stacked on top of the circuit board 340 (not shown) or placed side-by-side (as shown). In an embodiment, the battery has a diameter of about 2 centimeters and a thickness of about 1 millimeter. In a further embodiment, the battery is opaque. In an example implementation, the battery may be a coin cell battery (e.g., lithium ion). In yet a further embodiment, the battery may be transparent. In yet a further embodiment, the battery may be flexible.


The circuit board 340 is adapted to convert a voltage differential from the battery 350 into pulsed waveform patterns as described herein. In an embodiment, a timer integrated circuit is utilized for pulse generation. In another embodiment, an operational amplifier is used for current delivery. In some implementations, a microcontroller may be used; in other implementations, a less complicated (and therefore less power consuming) chip may be utilized (e.g., an application-specific integrated circuit). In some implementations, an aperture in a chip (not shown) of the circuit board 340 may be defined in order to allow for placement of the battery therein.


The various components shown in FIG. 3 may be encased or otherwise enclosed in a film (not depicted in FIG. 3) used to realize the device 300 as a patch. In some implementations, the film may be transparent in order to allow natural skin color to show through the film. Such a film may be around 0.2 millimeters thick. Moreover, the film may be made of materials such as, but not limited to, silicone, plastic, resin, epoxy, thin-film laminates, metals, sprayable conformal coatings (e.g., parylene, silicone dioxide, polytetrafluoroethylene, acrylic, epoxy, etc.) combinations thereof, and the like. The film, in at least some embodiments, may be used to form a water-resistant enclosure. In other embodiments a water-resistant film is applied directly to all electrical sub-components.



FIG. 4 is a diagram illustrating a dumbbell-shaped design of a device 400 according to an embodiment.


As depicted in FIG. 4, a pair of electrodes 420-1 and 420-2 are connected via a wire 430. In the embodiment shown in FIG. 4, a circuit board 440 is stacked on top of one of the electrodes 420-1 and a battery 450 is stacked on top of another of the electrodes 420-2. Such a stacking design may reduce the area of the device 400 that is opaque (e.g., allowing more space to be occupied by a transparent film) in exchange for increased thickness of the device 400.


In an embodiment, the electrodes 420-1 and 420-2 each have a diameter of 2 centimeters and a thickness of 1 millimeter. The circuit board 440 may be opaque and, in an embodiment, has a surface area equal to or greater than 3 centimeters. The battery 450 maybe opaque and, in an embodiment, have a thickness of 1.6 millimeters and a diameter of 2 centimeters. In some embodiments, the electrodes 420-1 and 420-2 are surrounded by edges 460-1 and 460-2, respectively, which extend at least 1 centimeter beyond the outer boundary of the respective electrodes 420-1 and 420-2.



FIG. 5 is a diagram illustrating a necklace-shaped design of a device 500 according to an embodiment. In this regard, it is noted that a device 500 which wraps around a user's neck may be desirable in order to demonstrate a natural-looking appearance like neckwear such as necklaces or scarves, or to be covered by such neckwear. The embodiment depicted in FIG. 5 may provide such a natural-looking or convenient to cover appearance.


As depicted in FIG. 5, electrodes 510-1 and 510-2 are connected via a wire 520 designed to wrap around a neck (not shown in FIG. 5). To this end, the wire 520 may be long enough (e.g., between 10 and 20 inches) in order to allow the wire to wrap around a user's neck. Moreover, in some implementations, the wire may be made of metal in order to appear more like a necklace. A circuit board 530 and a battery 540 may be stacked on top of the electrodes 510-1 and 510-2, respectively.


In an embodiment, the electrodes 510-1 and 510-2 each have a diameter of 2 centimeters and a thickness of 1 millimeter. The circuit board 530 may be opaque and, in an embodiment, has a surface area equal to or greater than 3 centimeters. The battery 540 maybe opaque and, in an embodiment, have a thickness of 1.6 millimeters and a diameter of 2 centimeters. The electrodes 510-1 and 510-2 may be surrounded by edges 550-1 and 550-2, respectively, which extend at least 1 centimeter beyond the outer boundary of the respective electrodes 510-1 and 510-2.


In some embodiments, wiring between a microchip and electrodes is used to create a pattern within a film section of a patch including a device. In an embodiment, the pattern is a trace pattern. An example wire diagram illustrating such a trace pattern is now described with respect to FIG. 6. In some embodiments, the wire traces are embedded in the thin film.



FIG. 6 is a wire diagram 600 illustrating connections between terminals and electrodes according to an embodiment. As depicted in FIG. 6, a device 610 has a set of wires 620 forming a trace pattern. The wire diagram 600 further indicates a location 630 upon which a housing (not shown) may be placed. Such a housing may include, but is not limited to, a circuit board and a battery. Non-limiting example housing components are described further below with respect to FIG. 14. In some embodiments, a microphone (not shown) may also be included.


The wire diagram 600 further illustrates a set of connection terminals 640-1 and 640-2 which may be utilized to electrically connect to a microchip disposed in the housing (not shown) placed upon the location 630. Such a microchip may have two separate outputs which may connect to two distinct respective electrodes 650-1 and 650-2. In some embodiments, a plurality of distinct outputs and electrode contacts points can be used. Multiple electrodes allow for current to flow inwards from one electrode into the tissue and outwards from the tissue into the other electrode. In a further embodiment, one of the electrodes (e.g., the electrode 650-1) only connects to one terminal (e.g., the terminal 640-1), while the other electrode (e.g., the electrode 650-2) only connects to another terminal (e.g., the terminal 640-2).



FIG. 7 is a diagram illustrating a bandage-shaped design of a patch 700 according to an embodiment. As depicted in FIG. 7, the patch 700 includes a surface 710 with two electrodes 720 and 730 disposed thereon. The surface 710 may be made of one or more layers such as, but not limited to, an adhesive layer. In some embodiments, the adhesive layer is located on the entire surface 710 of the patch 700 except for portions of the surface 710 where the electrodes 720 and 730 are disposed. In some embodiments, the edges of the patch 700 are rounded in order to improve comfort at skin interface. An example set of layers which may be utilized to realize the surface 710 is discussed further below with respect to FIG. 11.


It should be noted that the various embodiments discussed with respect to FIGS. 3-7 are described with respect to two electrodes, but that additional electrodes may be utilized in accordance with at least some disclosed embodiments. Moreover, the electrodes depicted in FIGS. 3-7 are circular in shape, but that other shapes may be equally utilized without departing from the scope of the disclosure.



FIG. 8 is a schematic diagram 800 of electrical components in accordance with various disclosed embodiments. The diagram 800 illustrates an example system topology.


The example system topology illustrated in FIG. 8 may be realized on or otherwise via a printed circuit board (PCB, not shown in FIG. 8). In some non-limiting implementations, the PCB may be a rigid type PCB. In other implementations, a flex type PCB may be utilized.


As depicted in FIG. 8, an electrical source 810 such as a battery is electrically connected to a load switch 820, which in turn is communicatively connected to switch latch logic 830 and to a voltage multiplier 840. The voltage multiplier 840 may be, but is not limited to, a Dickson charge pump, and may be utilized for a current sink supply. The voltage multiplier 840 is connected to an impedance detection circuit 850 and a H-bridge 860.


In at least some implementations, the electrical source 810 is adapted such that it is capable of powering a device as described herein for at least 8 hours of continuous use. In a further implementation, the electrical source 810 is adapted to enable at least 12 hours of continuous device use. The electrical source 810 may be, but is not limited to, a non-rechargeable battery, a durable rechargeable battery, and the like. Non-limiting example types of battery which may be utilized in accordance with various implementations include alkaline, lithium-ion, lead-acid, nickel-cadmium, nickel-metal hydride, lithium polymer, zinc-Carbone, silver oxide, zinc-air, and the like.


In an embodiment, the electrical source 810 is adapted such that a device including the electrical source 810 is adapted to apply a continuous stimulation pattern for a time period between 1 and 12 hours. In a further embodiment, the device is adapted such that a maximum length of time of quiescence is 10 seconds during the time period in which the continuous stimulation pattern is applied. That is, the maximum duration of any period of inactive time (i.e., time in which pulses are not being emitted) during the stimulation is 10 seconds. In another embodiment, the device is adapted such that a maximum length of time of quiescence is 100 milliseconds during the time period in which the continuous stimulation pattern is applied.


Outputs of the impedance detection circuit 850 are input to a controller 870, which in turn sends control signals to the switch latch logic 830, the voltage multiplier 840, the H-bridge 860, a first current sink 880-1, and a second current sink 880-2. An additional charge pump (not shown) may be integrated into a chip (not shown) of the controller 870 in order to provide a target voltage output such as, but not limited to, an output of about 9 volts with a maximum current amplitude of around 10 milliamps. The H-bridge 860 may deliver power to a pair of electrodes 890-1 and 890-2.


In an embodiment, the system topology shown in FIG. 8 is utilized to deliver an output current pulse having an amplitude between 4 and 12 Milliamps (mA), a square bi-polar (biphasic) waveform, having two phases each with a width of 100 microseconds per phase (for a 200 microsecond long total pulse), and a repetition frequency of 30 Hertz (Hz). In some embodiments, the frequency is between 15 and 90 Hz. The square biphasic waveform may include multiple energy pulses having the two phases. In some embodiments, the width per phase is between 50 and 500 microseconds. In some embodiments, the phases have different widths.


That is, the system topology may be utilized to repeatedly deliver stimulation pulses. These pulses have an induced change in electrical potential between two points (e.g., points of electrodes as discussed herein), which causes current to flow through the tissue between the electrodes 890-1 and 890-2. In some embodiments, the pulses are biphasic pulses which alternate the current direction at some point during the pulse (which prevents charge build up in the tissue and improves activation of neural targets). In a further embodiment, the amplitude may be configurable to different predetermined settings. In yet a further embodiment, the predetermined settings include 5 mA, 7 mA, and 9 mA. In another embodiment, the current pulse which is delivered is between 7 to 12 mA. Alternatively, the current pulse which is delivered is less than or equal to 60 mA. It has been discovered that 60 mA is likely a top end of a safe range of potential amplitude values. It has also been identified that 7 to 12 mA may provide optimal stimulation conditions for at least some disclosed embodiments. It has been identified that such ranges tend to be comfortably tolerated by subjects with normal body mass index. Higher current levels (up to 60 mA) may be used in at least some embodiments in order to properly reach and engage the vagus nerve in targets with relatively more deep vagus nerve locations relative to skin surface (e.g., obese users).


In some embodiments, a time of around 0.01 milliseconds (ms) is inserted between phases of the biphasic pulse in order to produce an interphase gap. In this regard, it has been identified that such an interphase gap has demonstrated effectiveness in improving activation of target neural structures, which in turn can further enhance sensory processing, minimize or avoid side effects of nerve stimulation, or both, in accordance with various disclosed embodiments.


In another embodiment, an asymmetric biphasic waveform is used. More specifically, in a further embodiment, a second phase of the biphasic waveform is between 10 and 30 percent weaker than a first phase (e.g., weaker as measured in current amps, i.e., 10 to 30 percent lower current amps). In this regard, it is identified that symmetric biphasic waves can, in at least some instances, cause depolarization from charge build up over time because the potential within the tissue is affected slightly differently by the first and second phase due to the effects of the first phase slightly influencing the effects of the second phase (e.g., during extended use). Accordingly, using a slightly asymmetric biphasic waveform such as a waveform where the second phase is 10 to 30 percent weaker than the first phase may avoid or otherwise mitigate depolarization.


In some embodiments, electrical current is provided according to a ramp-up procedure. In such a ramp-up procedure, the full amplitude current of the stimulation pattern to be applied is not provided initially when the device or patch is applied to the skin. In this regard, it has been identified that a sudden change from no stimulation to full strength stimulation (e.g., at a rate of over 10 mA/second) may be shocking or uncomfortable for the user. To this end, in some further embodiments, amplitude may be increased in incremental steps (e.g., increasing by 0.05 mA/second). In a further embodiment, a ramp-up pace between 1 and 10 mA/second is utilized to increase the amplitude in incremental steps. In yet a further embodiment, a ramp-up pace between 1 and 5 mA/second is utilized. In this regard, it has been discovered that a ramp-up pace between 1 and 5 mA/second tends to provide the least amount of discomfort.


In a further embodiment, the ramp-up procedure begins with an immediate increase in stimulation to a first level, and then incrementally increasing the amplitude to a second level (i.e., the full amplitude current to be delivered) in multiple increments. In some embodiments, a current value between 1 and 5 mA is used as the first level to be applied immediately upon stimulation beginning. In a further embodiment, a current value of 5 mA is used as the first level, and a current value between 7 and 12 mA is used as the second level (full amplitude current). Alternatively, the second level may be any value up to 60 mA.


In this regard, it has been discovered that a slow ramp-up to the full amplitude current tends to cause more discomfort for users than an immediate jump to a lower level of current followed by a ramp-up to the full level of current. It has further been discovered that current values between 1 and 5 mA are the lowest perceptible current for most individuals using the stimulation pattern as described herein. It has also been identified that some individuals exhibit more discomfort for current values between 1 and 5 mA than for a current value of 5 mA such that, for some implementations, it may be desirable to jump immediately to 5 mA to minimize discomfort. It has further been discovered that maximum current values between 7 and 12 mA have been found to provide adequate stimulation for many use cases without causing significant levels of discomfort such that current values between 7 and 12 mA may be suitable full amplitude current values. That said, it has been discovered that current values up to 60 mA are safe levels even if some higher current values up to 60 mA may cause additional discomfort. In that regard, it is noted that some implementations and use cases may tolerate additional discomfort in exchange for a higher current (e.g., to further enhance sensory processing). For example, a military use case, a life-or-death situation, or an athlete may tolerate some degree of discomfort for further improved performance.


In an embodiment, the frequency, waveform, or both, of the stimulation pattern may affect the thresholds to be used. For example, certain frequencies or waveforms may be perceptible at current values outside of 1 to 5 mA and, consequently, the first level may be set to a different current value in accordance with certain embodiments and implementations in order to cause initial perception while reducing overall discomfort.


In order to provide a ramp-up as discussed above and to ensure that current is only delivered when product is properly applied to skin, in some embodiments, a circuit designed to deliver transcutaneous stimulation is adapted to measure an impedance value of an attached load and to deliver stimulation when an appropriate load is indicated (e.g., above a predetermined threshold or within a predetermined range of appropriate loads such as, but not limited to, between 500 and 2000 ohms). The ramp-up may be facilitated by adjusting, for example but not limited to, a time course of a charging capacitor which is adapted to create a voltage signal that ramps up over time until it reaches a saturation value and for which the ramp rate properties can be adjusted by varying properties of the capacitor.



FIG. 9 is a system diagram 900 utilized to describe various disclosed embodiments. As depicted in FIG. 9, a power source 910 provides power to a controller 920. The controller 920 is activated via a switch 930. The controller 920 sends control signals to a current source bridge 940, which in turn power a pair of electrodes 950-1 and 950-2.


The controller 920 may be realized via one or more chips such as, but not limited to, microchips. As discussed herein, such microchips may be disposed on a printed circuit board (PCB) and enclosed in a housing. The housing may further be designed to create a tight seal in order to prevent water or other fluids from entering the housing and affecting the controller 920. In some embodiments, the chip is enclosed within a film of a patch (not shown) without requiring a housing.


In some embodiments, a physical switch 930 is adapted to keep a battery such as the power source 910 electrically disconnected from the electrodes 950-1 and 950-2 until the battery is removed from packaging (not shown). This may be utilized in order to prevent the battery from draining while in transit and storage. In some embodiments, a digital switch 930 may further be connected to one or more sensors (not shown) configured to measure one or more metrics such as, but not limited to, impedance, current, voltage, resistance, combinations thereof, and the like. Measuring these metrics allows for determining whether any of these metrics are above a threshold, below a threshold, between thresholds, and the like. In such an embodiment where the switch 930 is connected to sensors, the switch 930 is configured to turn on or off depending on whether one or more metrics are above, below, or between, respective thresholds. In this regard, a device incorporating the switch 930 and any such sensors is adapted to monitor metrics such as impedance, current, voltage, or resistance, and to turn on (thereby applying current) or shut down (thereby ceasing application of current). Sensors or other components used to measure such metrics may include, but are not limited to, voltage dividers, a resistor with a known value resistance or impedance, one or more comparator circuits (e.g., circuits configured to compare voltage with a reference voltage in order to output values indicating when one voltage is higher than the other), digital control logic, combinations thereof, and the like.


In particular, in some embodiments, a resistive sensor adapted to measure resistance is connected to the switch 930, and the switch 930 is configured to turn on when the resistance measured by the resistive sensor is above a predetermined threshold. Turning the device on when a certain amount of resistance has been detected may be utilized to effectively determine whether a patch or device as described herein is applied to skin and delivering current as described herein only when the device is applied to skin.


In another embodiment, an impedance sensor adapted to measure impedance across the electrodes 950-1 and 950-2 is connected to the switch 930, and the switch 930 is configured to turn on when the impedance measured by the impedance sensor is above a threshold, below a threshold, or within a range bound by thresholds. In this regard, a device incorporating the switch 930 and such an impedance sensor may be effectively adapted to shut down when an appropriate load is not present as defined with respect to one or more predetermined thresholds (e.g., when the impedance is below a predetermined threshold, above a predetermined threshold, outside of a range, combinations thereof, etc.). In a further embodiment, the range of appropriate loads may be between 400 and 4000 Ohms. In some embodiments, stimulation may resume when the load is once again at an appropriate level (e.g., above a threshold, below a threshold, or within a range).


In this regard, it is noted that a device not being appropriately applied to skin may cause impedance or other metrics to fall outside of safe ranges. In such a case, for example, when electrodes of a device are placed such that they do not fully contact an appropriate surface area of the user's skin, such a lack of full contact may cause any current delivered to the skin to exceed a safe or comfortable amount of current given the surface area to which the current is effectively applied. As a non-limiting example, when the device is implemented in a patch which begins to peel such that one of the electrodes ceases being in contact with the skin, a situation in which the device would send the same amount of current through half of the normal surface area of the skin may occur. This imbalance of current to surface area may cause discomfort or injury such that detecting impedance above a threshold and ceasing stimulation when impedance is above the threshold may avoid discomfort or injury. To this end, in an embodiment, the device may be adapted to cease stimulation when the impedance is above a threshold of 10,000 ohms.


Likewise, impedance below a threshold may indicate that the device has short circuited such that the electrodes are not properly electrically isolated from each other. For example, in an embodiment, a normal impedance range may be between 200 and 4000 ohms such that an impedance below 200 ohms may be indicative of a short circuit. In such a case, the device may shut off when the impedance drops below 200 ohms. Impedance may be measured using components or techniques such as, but not limited to, time-domain reflectometry, frequency domain analysis, Wheatstone bridge, impedance-to-digital conversion chips, combinations thereof, and the like.


Similarly, other safety or proper operation thresholds may include, but are not limited to, overvoltage protection thresholds (e.g., over 24 volts), undervoltage protection thresholds (e.g., less than 1 volt), overcurrent protection thresholds (e.g., greater than 1 milliamp above target current), combinations thereof, and the like.


In some embodiments, the switch 930 may be physically attached to packaging such that the switch 930 is pulled (and therefore activated) as part of removing the device from the packaging. In such an implementation, the switch 930 may be realized as a pull-tab or tear strip switch. In other implementations, the switch 930 may be magnetic and held in an “off” position by a small magnet included in the packaging for the device. When the packaging is removed from the device, the removal of the magnet causes the switch 930 to change to an “on” position. Other types of switches (e.g., optical, capacitive, inductive, etc.) may be utilized without departing from the scope of the disclosure.


In other embodiments, the switch 930 may be connected to a button (not shown) disposed on a device such that, when the button is pressed, the switch 930 may activate stimulation as discussed herein. The button may be realized as, for example but not limited to, a toggle, rocker, push, slide, tactile button, capacitive button, physical switch, combination thereof, and the like. In a further embodiment, pressing the button while current is being delivered (i.e., while stimulation is active) may cause the stimulation to deactivate and current to cease being delivered. Some such embodiments may utilize multiple switches or otherwise allow for both activating/deactivating the device via press of a button and activating or deactivating the device when one or more electrical metrics (e.g., voltage, current, impedance, resistance, etc.) meet a threshold or fall within a range as discussed above.



FIG. 10 is a hardware architecture diagram 1000 utilized to describe various disclosed embodiments. The hardware architecture diagram illustrates connections and flows between components including a power source 1001, a load switch 1002, a first clock (e.g., a 1 Kilohertz CLK) 1003, a voltage multiplier or charge pump 1004, a circuit (e.g., a S-R latch 1005), a watch-dog logic component 1006, a comparator 1007, a threshold 1008, a second clock (e.g., a 30 Hertz CLK) 1009, a third clock (e.g., a 1 Hertz CLK) 1010, a ramp logic component 1011, a first pulse generator (e.g., a 100 microsecond pulse generator) 1012, a second pulse generator (e.g., a 100 microsecond pulse generator) 1013, and a pair of electrodes 1014-1 and 1014-2. The ramp logic component 1011 is designed to control ramping up of current, for example as discussed further above.



FIG. 11 is a top exploded view illustrating components of a patch 1100 according to an embodiment. The top exploded view illustrates components including a top cover 1110, a housing 1125 disposed on an electrode apparatus 1120, an adhesive layer of the adhesive layer 1130 of the patch 1100, and a bottom layer 1140. Specifically, FIG. 11 illustrates an assembled version of the patch 1100 including packaging components in the form of a top cover 1110 and a bottom layer 1140.


The top cover 1110 depicted in FIG. 11 is made of a plastic material which may be utilized to protect the patch 1100, for example, during shipping. As discussed above, in some implementations, a film (not shown) may be utilized as a top layer instead of the top cover 1110 depicted in FIG. 11.


The housing 1125 is disposed on the electrode apparatus 1120 and may house components such as, but not limited to, electrodes, wires, circuit boards, and the like. Example components which may be housed in the housing 1125 are described further below with respect to FIG. 14.


The adhesive layer 1130 may be glue or another adhesive used to secure the electrode apparatus 1120 to the skin of the user. The top cover 1110, in order to seal the electrode apparatus 1120 and housing 1125 within a sealed chamber, creates a chamber formed between the top cover 1110 and the bottom layer 1140.


That is, the top cover 1110 and the bottom layer 1140 may be affixed in order to form a chamber holding the components of the patch 1100 during shipping. To this end, the bottom layer 1140 may further include one or more adhesives (not shown) which are used to adhere the bottom layer 1140 to the top cover 1110. The top cover 1110 and the bottom layer 1140 may be separated in order to remove the patch 1100 from such a chamber such that remaining components (e.g., the electrode apparatus 1120 and the adhesive layer 1130) may be removed from the packaging when the electrode apparatus 1120 is to be applied to the skin of a user.


The adhesive layer 1130 covers a surface of the patch 1100 where the patch 1100 is to be attached to the skin of a user and may further be utilized to create an electrically insulating barrier between electrodes. Such an electrically insulating barrier may prevent liquids or other foreign materials from creating a short circuit. In some embodiments, the adhesive layer 1130 is made out of silicone, acrylic, hydrocolloid, polyurethane, Tegaderm, and the like.


In some embodiments, an area of a portion of the adhesive surrounding each electrode of the electrode apparatus 1120 is around 0.5 centimeters thick. Such a 0.5 centimeter thick area around the portion of the adhesive may allow for holding the electrodes to the skin and creating a waterproof seal around the electrodes. In a further embodiment, a thickness of the adhesive is at least 5 millimeters in order to provide a waterproof barrier, a conduction barrier, or both.


In some embodiments, the adhesive layer 1130 may be further attached to a backing layer (not shown) that covers the adhesive until the patch 1100 is to be used. Such a backing layer may have a thickness of around 0.1 millimeters.


In some embodiments, the adhesive layer 1130 of the patch 1100 that interfaces with the skin may be made of two materials including an adhesive material and a conductive material (not shown), where the sections of the conductive material may act as electrodes to deliver electrical current in accordance with one or more disclosed embodiments. In such embodiments, the portion of the adhesive layer 1140 made of the adhesive material is between 0.1 and 1 millimeters thick.



FIG. 12 is a bottom exploded view illustrating the components of the patch 1100 according to an embodiment.



FIG. 13 is an assembled view 1300 of a device according to an embodiment. The assembled view 1300 illustrates a top cover 1310 and a housing 1325. The housing 1325 may include components as now described with respect to FIG. 14.



FIG. 14 is an exploded view of the housing 1325 according to an embodiment. The housing 1325 includes a connecting member 1410, a base 1420, a circuit board 1430, a battery 1440, and a cover 1450. The connecting member 1410 may be disposed on or attached to a device (e.g., the patch 700, FIG. 7), and may facilitate electrically connecting the circuit board 1430 with an electrode (e.g., the electrode 720 or the electrode 730, FIG. 7), for example via one or more wires as discussed above with respect to FIG. 6.


The base 1420 may be affixed to the cover 1450 in order to enclose the housing between the device and the connecting member 1410 with the cover 1450. The base 1420 and the cover 1450 may therefore be utilized to realize an enclosed cavity in which the other components of the device shown in FIG. 14 are disposed.


The circuit board 1430 may be configured to deliver electric pulses when the device is disposed on a nerve as described herein. To this end, the circuit board 1430 is electrically connected to the battery 1440. The battery 1440 provides electricity for distribution to electrodes (e.g., the electrodes 720 and 730 as shown in FIG. 7).



FIG. 15 is an illustration 1500 of a patch 1520 placed on a user 1510. The patch 1520 may be designed in accordance with one or more of the disclosed embodiments, for example, as described above with respect to FIGS. 11-14.



FIG. 16 is a diagram illustrating a dual-member design of a device 1600 according to an embodiment. The device 1600 depicted in FIG. 16 shows a housing of a device (e.g., housing enclosing components such as those described further above with respect to FIG. 14) and a pair of elongated members 1610-1 and 1610-2. As depicted in FIG. 16, the members 1610-1 and 1610-2 includes wire leads 1611-1 and 1611-2, respectively, and electrodes 1612-1 and 1612-2, respectively.


In an embodiment, a length of each of the members 1610-1 and 1610-2 is around half


of a predetermined neck circumference value (e.g., a known average neck circumference). In a further embodiment, the length of each of the members 1610-1 and 1610-2 is between 5 and 10 inches.


In an embodiment, the wire leads 1611-1 and 1611-2 are the same or roughly the same distance. The members 1610-1 and 1610-2 may be spaced such that the electrodes 1612-1 and 1612-2 are located at least a threshold distance apart (e.g., between 2 and 6centimeters) such that the electrodes 1612-1 and 1612-2 may be placed such a threshold distance apart on the carotid triangle in order to enable stimulation as discussed herein. For example, a distance between center lines of the members may be equal to or otherwise based on an interelectrode distance of the electrodes. In a further embodiment, the electrodes 1612-1 and 1612-2 are around 3 to 4 centimeters apart as measured from center point to center point. Moreover, as discussed above, in at least some embodiments, the surface area of each of the electrodes 1612-1 and 1612-2 may be at least 2 square centimeters in order to maintain a total ratio of electrode to skin surface area for ensuring current density during stimulation without increasing current density to a level where discomfort or injury might occur.


The device 1600 may further include a housing 1620 containing components such as, but not limited to, a power source (e.g., a battery) and a controller (e.g., a microchip).



FIG. 17 is a diagram 1700 illustrating flexibility of members of the device 1600 according to an embodiment. As depicted in FIG. 17, the device 1600 includes members 1610 which are flexible. Such flexibility may allow the members 1610 to be adjusted to the contours of a user's neck in order to improve comfort, appearance, both, and the like.


In some embodiments, the members 1610 of the device 1600 may include angled ends in order to facilitate a desired spacing of the electrodes. An example of such angled members is now described with respect to FIG. 18.



FIG. 18 is a diagram illustrating a forked dual-member design of a device 1800 according to an embodiment. As depicted in FIG. 18, the device 1800 includes a pair of members 1810-1 and 1810-2. The members 1810-1 and 1810-2 have forked ends 1820-1 and 1820-2 having electrodes 1830-1 and 1830-2, respectively. The forked design of the device 1800 may further aid a user in properly placing the device 1800 for stimulation and, in particular, to ensure appropriate spacing of the electrodes 1830-1 and 1830-2. To this end, in some embodiments, the forked ends 1820-1 and 1820-2 diverge from a direction of their respective members 1810-1 and 1810-2 at an angle between 30 and 60 degrees. In a further embodiment, the forked ends 1820-1 and 1820-2 diverge at a point that is between 1 to 2 inches from the electrodes 1830-1 and 1830-2 (e.g., as measured from center points of the electrodes 1830-1 and 1830-2) in order to ensure that the center points of the electrodes 1830-1 and 1830-2 are appropriately spaced.



FIG. 19 is an illustration 1900 of a dual-member device 1920 placed on a user 1910. As depicted in FIG. 19, the device 1920 may be placed such that the members are disposed on a carotid triangle of the user 1910 and a housing may be placed higher up on the user's neck, which may allow the housing to be partially or fully hidden from view, for example for aesthetic purposes.



FIG. 20 is a schematic diagram of a hardware layer 2000 of computing components of a device according to an embodiment. The hardware layer 2000 includes a processing circuitry 2010 coupled to a memory 2020, a storage 2030, and a computing interface 2040. In an embodiment, the components of the hardware layer 2000 may be communicatively connected via a bus 2050.


The processing circuitry 2010 may be realized as one or more hardware logic components and circuits. For example, and without limitation, illustrative types of hardware logic components that can be used include field programmable gate arrays (FPGAs), application-specific integrated circuits (ASICs), Application-specific standard products (ASSPs), system-on-a-chip systems (SOCs), graphics processing units (GPUs), tensor processing units (TPUs), general-purpose microprocessors, microcontrollers, digital signal processors (DSPs), and the like, or any other hardware logic components that can perform calculations or other manipulations of information.


The memory 2020 may be volatile (e.g., random access memory, etc.), non-volatile (e.g., read only memory, flash memory, etc.), or a combination thereof.


In one configuration, software for implementing one or more embodiments disclosed herein may be stored in the storage 2030. In another configuration, the memory 2020 is configured to store such software. Software shall be construed broadly to mean any type of instructions, whether referred to as software, firmware, middleware, microcode, hardware description language, or otherwise. Instructions may include code (e.g., in source code format, binary code format, executable code format, or any other suitable format of code). The instructions, when executed by the processing circuitry 2010, cause the processing circuitry 2010 to perform the various processes described herein.


The storage 2030 may be magnetic storage, optical storage, and the like, and may be realized, for example, as flash memory or other memory technology, compact disk-read only memory (CD-ROM), Digital Versatile Disks (DVDs), or any other medium which can be used to store the desired information.


The computing interface 2040 allows the hardware layer 2000 to communicate with other systems, devices, components, applications, or other hardware or software components, for example as described herein. In some implementations, the computing interface 2040 may be or may include a network interface, for example, a network interface used to communicate with one or more user devices having installed thereon software for delivering audio content to a user as discussed below with respect to FIG. 23.


It should be understood that the embodiments described herein are not limited to the specific architecture illustrated in FIG. 20, and other architectures may be equally used without departing from the scope of the disclosed embodiments.



FIG. 21 is a flowchart 2100 illustrating a method for vagus nerve stimulation according to an embodiment. In an embodiment, the method is performed via the hardware layer 2000, FIG. 20. In a further embodiment, the device is a device as described in one or more of the disclosed embodiments.


At S2110, a request for sensory processing enhancement is received. The request may be received, for example, based on user inputs (e.g., inputs indicating a user request for sensory processing enhancement), based on an automated program (e.g., a program configured to detect hearing loss), and the like. In some embodiments, the request may further indicate a degree of stimulation to be applied. User inputs may be received, for example but not limited to, from a user device of the user (e.g., via a software application installed on the user device), or via one or more buttons or other physical components of the device. The request for sensory processing may further indicate timing, duration, or both, for the stimulation.


At S2120, stimulation is activated. In an embodiment, S2120 includes sending one or more signals including commands for stimulation to one or more components of the device configured to provide nerve stimulation. In particular, such components may be or may include one or more components (e.g., electrodes) configured to apply electrical currents to the user in order to stimulate sensory processing as discussed herein.


In an embodiment, the device is a device configured in accordance with one or more disclosed embodiments. In a further embodiment, the device is disposed on one or more arteries of the user. In yet a further embodiment, the device is disposed on a carotid triangle of a neck of the user. In any such embodiments, the device is configured for vagus nerve stimulation as described herein.


In an embodiment, the stimulation is delivered using an uninterrupted tonic stimulation pattern. As noted above, such a pattern may improve effects on sensory perception, for example as compared to a duty-cycled stimulation pattern or other alternating or fluctuating stimulation pattern. Such stimulation may be delivered to the vagus nerve in order to steadily activate the norepinephrine (NE) system in a manner that improves the ability of a brain of the user to accurately process sensory information.


In an embodiment, stimulation is applied using a continuous stimulation pattern for a time period between 1 and 12 hours. In a further embodiment, a maximum length of time of quiescence is 10 seconds during the time period in which the continuous stimulation pattern is applied. That is, the maximum duration of any period of inactive time (i.e., time in which pulses are not being emitted) during the stimulation is 10 seconds. In another embodiment, such a maximum length of time of quiescence is 100 milliseconds during the time period in which the continuous stimulation pattern is applied.


At S2130, a trigger for ceasing sensory processing enhancement is detected. Such a trigger may be or may include, but is not limited to, passage of a predetermined period of time since beginning enhancement, passage of a duration of time indicated in the request, an end of detection of sensory signals, a combination thereof, and the like.


For any of the devices described herein, the stimulation device acting as a first device may be connected to a second device such as, but not limited to, a hearing aid. More specifically, the first device may be connected, either wired or wirelessly, to a second device having one or more components which may be leveraged by the stimulation device in order to realize stimulation in accordance with one or more of the disclosed embodiments.


For example, in some embodiments, the stimulation device acting as the first device may be electrically connected to the second device in order to leverage a power source such as a battery of the second device. In such an embodiment, the first device may exclude such a power source. As another example, in some embodiments, the second device may include a controller such as a microchip configured to send control signals for causing delivery of current to electrodes of the first device, and the first device may exclude such a controller, a power source, or both.


In this regard, it is noted that health of sensory processing has been shown to be strongly linked to dementia and Alzheimer's disease (AD). Specifically, hearing loss has been shown to be linked to accelerated dementia and AD onset and progression. Accordingly, an inter-device implementation may allow for integrating a stimulation device with a hearing aid or other supporting device which may be utilized to support a user having sensory processing deficiencies.


It is also noted that ease of central sensory processing and ability to memorize information delivered via vision, hearing, or touch are linked. It is further noted that the presence of background noise can reduce verbal working memory even when the background noise is not otherwise loud enough to prevent hearing or understanding spoken words. Accordingly, certain inter-device embodiments may be utilized to enhance sensory processing when background noise may interfere with processing of words spoken during conversations in order to improve memory, to mitigate effects of conditions which cause sensory deficiencies, and the like.



FIG. 22 is a diagram 2200 illustrating a first device 2210 connected to a second device 2230 via a wire 2220 according to an embodiment. As depicted in FIG. 22, the second device 2230 is a hearing aid disposed on an ear 2235 of a subject 2205. It should be noted that other devices may be utilized in accordance with at least some disclosed embodiments. The first device 2210 and the second device 2230, with or without the wire 2220, may form an apparatus for inter-device stimulation which uses components from one device and components from the other device in order to realize stimulation, for example, of the vagus nerve as described herein.


The embodiment depicted in FIG. 22 is an embodiment in which the first device 2210 at least includes a pair of electrodes 2211-1 and 2211-2. The first device 2210 is adapted to use the pair of electrodes 2211 in accordance with various disclosed embodiments to stimulate a vagus nerve of a subject 2205, for example by placing the first device 2210 on a carotid triangle 2215 of the subject 2205. As discussed herein, such a device may include components such as, but not limited to, one or more pairs of electrodes, a power source such as a battery, and a controller such as a microchip.


In an embodiment where the first device 2210 is communicatively connected, electrically connected, or both (for example, via the wire 2220 or via a wireless connection as depicted in FIG. 23), to the second device 2230, the first device 2210 may be adapted to leverage one or more components of the second device 2230 in order to perform stimulation. For example, the first device 2210 may deliver pulses using current from a power source of the second device 2230, may be controlled via control signals sent from a controller of the second device 2230, or both. Leveraging components of the second device 2230 may allow, for example, for reducing the size, complexity, manufacturing cost, materials usage, and the like, needed to realize the first device 2210. That is, in accordance with various disclosed embodiments, nerve stimulation is realized using a power source, one or more pairs of electrodes, and a controller. In at least some of those embodiments, a device containing the pairs of electrodes may leverage components of another device in order to perform stimulation.


In some embodiments, the device 2210 further includes a microphone 2212. The microphone 2212 may be utilized, for example, to detect speaking or other background noise in order to trigger stimulation as described further below with respect to FIGS. 24 and 25. In other implementations (not shown), the microphone 2212 may be excluded from the device 2210 or may be included in the second device 2230 and leveraged by the device 2210. A controller may be configured to process the audio captured by the microphone 2212 in order to make decisions related stimulation such as, but not limited to, triggers for performing stimulation, stimulation patterns or intensities, combinations thereof, and the like.



FIG. 23 is a diagram 2300 illustrating a first device 2210 connected to a second device 2230 wirelessly according to an embodiment.


In some embodiments (not shown), the first device 2210 includes a latching interface such as, but not limited to, one or more clasps, velcro, and the like. Such a latching interface may allow for placing different decorative exterior shells (not shown) over the first device 2201. To this end, the latching interface may be affixed to or otherwise connected to the first device 2210 and adapted to receive one or more such exterior shells.



FIG. 24 is a flowchart 2400 illustrating a method for stimulating based on background noise according to an embodiment. In an embodiment, the method is performed via the hardware layer 2000, FIG. 20. More specifically, the hardware layer 2000 may be implemented in a stimulation device (e.g., the first device as discussed above) or in a supporting device (e.g., the second device such as a hearing aid as discussed above).


At S2410, a trigger event for stimulation is detected. The trigger event may be circumstances or another change which causes a need for stimulation to be initiated or increased such as, but not limited to, an increase or other change in background noise. In an embodiment, the trigger event is detected as described further below with respect to FIG. 25. In another embodiment, the trigger event may be a manual activation of the device by a user (e.g., by pressing a button on the device or interacting with a software application on a user device which is communicatively connected to a controller used for performing stimulation by the device).


At S2420, when the trigger event for stimulation is detected, stimulation is performed based on the trigger event. In an embodiment, performing the stimulation based on the trigger event includes sending control signals to a power source in order to cause delivery of current to electrodes. More specifically, such current may be delivered using certain waveform patterns, intensities, or both, as discussed herein. In a further embodiment, performing the stimulation based on the trigger event includes activating stimulation (e.g., when stimulation was inactive) or modifying a stimulation intensity (e.g., when stimulation is active).


When performing the stimulation includes increasing an intensity of stimulation, the stimulation may be increased by a predetermined amount or may be increased based on a degree of intensity increase to be achieved. Such a degree of intensity increase to be achieve may be determined, for example, based on a volume level of background noise. To this end, in a further embodiment, the intensity of stimulation may be modified using a function having external volume as an input a relative intensity (i.e., an intensity increase or other intensity value defined with respect to a current intensity) as an output. In such an embodiment, the intensity may be modified by changing any of peak amplitude, waveform width, waveform frequency, a combination thereof, and the like.


At S2430, a trigger event for returning stimulation to a prior status is detected. The prior status may be, but is not limited to, a prior state (e.g., returning to inactive status when the stimulation has been active), a lower or previous intensity, and the like. The trigger event for returning stimulation to the prior status may be, but is not limited to, circumstances or another change such as a drop in or cessation of background noise.


At S2440, when the trigger event for returning stimulation to a prior status is detected, stimulation is returned to the prior status. In an embodiment, S2440 includes ceasing control signals used for stimulation, modifying the control signals to decrease stimulation intensity, and the like.



FIG. 25 is a flowchart 2500 illustrating a method for triggering stimulation based on background noise according to an embodiment. In an embodiment, the method is performed via the hardware layer 2000, FIG. 20. More specifically, the hardware layer 2000 may be implemented in a stimulation device (e.g., the first device as discussed above) or in a supporting device (e.g., the second device such as a hearing aid as discussed above).


At S2510, audio inputs are monitored for changes in background noise. In an embodiment, the audio inputs include audio captured by one or more microphones such as, but not limited to, the microphone 2212. Such a microphone may be disposed in or on the stimulation device, the supporting device, and the like.


At S2520, a change in background noise is detected.


In some embodiments, the microphone used to capture the audio inputs is adapted to pick up a voice of a subject wearing the stimulation device, the supporting device, or both. In such embodiments, placement of the stimulation device including a microphone in the carotid triangle near the vocal cords is utilized to facilitate picking up the subject's voice.


In some embodiments, the stimulation device is further configured to broadcast an audio signal, for example via an inductive loop, Bluetooth, or another audio broadcasting system in order to allow the device to send the audio signal to another microphone (e.g., a microphone of a device worn by another subject within the environment in which the device is deployed). This may allow the microphone to function as a system for projecting the wearer's voice directly into one or more listening devices being used by other subjects who are conversing with the wearer.


At S2530, a trigger event is detected based on the change in background noise. In an embodiment, the trigger event is or includes detecting conversation between a subject and one or more other individuals. In a further embodiment, speech sensing software may be utilized to detect the conversation. In another embodiment, the trigger event is a higher level of background noise (e.g., background noise above a threshold). In a further embodiment, the threshold may be a predetermined sound pressure level threshold such that, when the sound pressure of audio signals captured via a microphone (e.g., the microphone 2212) is above the predetermined sound pressure level threshold, then stimulation may be performed (e.g., activated or using increase intensity).


In some embodiments (not shown), a device in accordance with one or more of the embodiments discussed above may be incorporated with one or more invasively implanted components (e.g., one or more surgically implanted components of a hearing aid). In such embodiments, a microphone, controller, battery, or combination thereof, which exists in a second device such as a hearing aid may be utilized to realize stimulation via a first device including one or more pairs of electrodes. That is, an implanted hearing aid or other supporting device may include a microphone, controller, battery, or combination thereof, and be used to generate pulses to be delivered via the electrodes of a stimulation device in accordance with various disclosed embodiments.


In such embodiments where a second device is at least partially invasively implanted into a subject, the at least partially implanted second device may include a chronically implanted transcutaneous interface port. In some embodiments, the transcutaneous interface port pierces the skin. In other embodiments, the transcutaneous interface port is implanted in a manner that is shallow enough that it can be communicated with transdermally.


In a further embodiment, the transcutaneous interface port may also be used as a point of access for invasive vagus nerve stimulation. To this end, in yet a further embodiment, the first device is implanted in a skin of the subject, and the implanted first device may have a wire lead running from a site at which the first device was implanted and the nerve (e.g., the vagus nerve) to be stimulated by the first device.


It should be noted that, in embodiments using implanted components, the first device, the second device, or both may be implanted. Moreover, each device which is implanted may be fully implanted (e.g., such that the device is wholly under a skin of the subject or otherwise entirely contained within the subject) or partially implanted (e.g., such that a portion of the device is under a skin of the subject and a portion of the device is outside of the subject). In embodiments where both devices are implanted, a wire lead between the devices may run subcutaneously between the devices. In a further embodiment, such a wire lead is between 3 and 9 inches long.


It is important to note that the embodiments disclosed herein are only examples of the many advantageous uses of the innovative teachings herein. In general, statements made in the specification of the present application do not necessarily limit any of the various claimed embodiments. Moreover, some statements may apply to some inventive features but not to others. In general, unless otherwise indicated, singular elements may be in plural and vice versa with no loss of generality. In the drawings, like numerals refer to like parts through several views.


At least some embodiments disclosed herein can be implemented as hardware, firmware, software, or any combination thereof. Moreover, the software may be implemented as an application program tangibly embodied on a program storage unit or computer readable medium consisting of parts, or of certain devices and/or a combination of devices. The application program may be uploaded to, and executed by, a machine comprising any suitable architecture. Preferably, the machine is implemented on a computer platform having hardware such as one or more central processing units (“CPUs”), a memory, and input/output interfaces. The computer platform may also include an operating system and microinstruction code. The various processes and functions described herein may be either part of the microinstruction code or part of the application program, or any combination thereof, which may be executed by a CPU, whether or not such a computer or processor is explicitly shown. In addition, various other peripheral units may be connected to the computer platform such as an additional data storage unit and a printing unit. Furthermore, a non-transitory computer readable medium is any computer readable medium except for a transitory propagating signal.


All examples and conditional language recited herein are intended for pedagogical purposes to aid the reader in understanding the principles of the disclosed embodiment and the concepts contributed by the inventor to furthering the art, and are to be construed as being without limitation to such specifically recited examples and conditions. Moreover, all statements herein reciting principles, aspects, and embodiments of the disclosed embodiments, as well as specific examples thereof, are intended to encompass both structural and functional equivalents thereof. Additionally, it is intended that such equivalents include both currently known equivalents as well as equivalents developed in the future, i.e., any elements developed that perform the same function, regardless of structure.


It should be understood that any reference to an element herein using a designation such as “first,” “second,” and so forth does not generally limit the quantity or order of those elements. Rather, these designations are generally used herein as a convenient method of distinguishing between two or more elements or instances of an element. Thus, a reference to first and second elements does not mean that only two elements may be employed there or that the first element must precede the second element in some manner. Also, unless stated otherwise, a set of elements comprises one or more elements.


As used herein, the phrase “at least one of” followed by a listing of items means that any of the listed items can be utilized individually, or any combination of two or more of the listed items can be utilized. For example, if a system is described as including “at least one of A, B, and C,” the system can include A alone; B alone; C alone; 2A; 2B; 2C; 3A; A and B in combination; B and C in combination; A and C in combination; A, B, and C in combination; 2A and C in combination; A, 3B, and 2C in combination; and the like.

Claims
  • 1. A device, comprising: a pair of electrodes, wherein the pair of electrodes is electrically connected to a power source, wherein the pair of electrodes is adapted to apply a current delivered from the power source to stimulate a vagus nerve of a subject, wherein an interelectrode distance between the pair of electrodes is defined based on a predetermined height of a carotid triangle, wherein the power source is communicatively connected to a controller, wherein the controller is configured to send control signals in order to control the current delivered from the power source to the pair of electrodes in a continuous stimulation pattern.
  • 2. The device of claim 1, wherein the device is a first device, further comprising: the power source, wherein the controller is included in a second device, wherein the second device is communicatively connected to the first device.
  • 3. The device of claim 1, wherein the device is a first device, further comprising: the controller, wherein the power source is included in a second device, wherein the second device is electrically connected to the first device.
  • 4. The device of claim 1, wherein the device is a first device, wherein the power source and the controller are included in a second device, wherein the second device is electrically connected to the first device.
  • 5. The device of claim 1, further comprising: a microphone adapted to capture audio including background noise of an environment in which the device is deployed, wherein the controller is further configured to detect a stimulation trigger based on the background noise and to send the control signals when the stimulation trigger is detected.
  • 6. The device of claim 5, wherein the stimulation trigger is detected based on the background noise being above a predetermined threshold.
  • 7. The device of claim 5, wherein the controller is further configured to utilize speech sensing software to analyze the captured audio in order to detect a conversation between the subject and at least one other individual, wherein the stimulation trigger is detected based on the detected conversation.
  • 8. The device of claim 1, wherein the interelectrode distance is between 4 and 5 centimeters.
  • 9. The device of claim 2, wherein the interelectrode distance is 4 centimeters.
  • 10. The device of claim 1, wherein the continuous stimulation pattern utilizes a plurality of pulses, wherein each pulse is less than one millisecond in length.
  • 11. The device of claim 1, wherein the continuous stimulation pattern is a continuous biphasic stimulation pattern.
  • 12. The device of claim 11, wherein the continuous stimulation pattern includes energy pulses with a square biphasic waveform having two phases.
  • 13. The device of claim 12, wherein each of the two phases of the square biphasic waveform is 100 milliseconds in length.
  • 14. The device of claim 1, wherein the continuous stimulation pattern utilizes a plurality of pulses delivered at a frequency between 15 and 60 Hertz.
  • 15. The device of claim 14, wherein the plurality of pulses is delivered at a frequency of 30 Hertz.
  • 16. The device of claim 14, wherein the plurality of pulses is delivered at a frequency of 45 Hertz.
  • 17. The device of claim 1, wherein the continuous stimulation pattern includes a square biphasic waveform.
  • 18. The device of claim 1, wherein the continuous stimulation pattern includes an asymmetric biphasic waveform.
  • 19. The device of claim 1, wherein the controller is further configured to cause the current delivered from the power source to the pair of electrodes in the continuous stimulation pattern at a first current level and then to incrementally increase the current from the first current level to a second current level.
  • 20. The device of claim 19, wherein the first current level is 5 milliamps.
  • 21. The device of claim 19, wherein the second current level is between 7 and 12milliamps.
  • 22. The device of claim 19, wherein the second current level is at most 60 milliamps.
  • 23. A stimulation apparatus, comprising: a first device, the first device further comprising a pair of electrodes, wherein an interelectrode distance between the pair of electrodes is defined based on a predetermined height of a carotid triangle; anda second device, the second device further comprising a power source, wherein the pair of electrodes is electrically connected to the power source, wherein the pair of electrodes is adapted to apply a current delivered from the power source to stimulate a vagus nerve of a subject, wherein the power source is communicatively connected to a controller, wherein the controller is configured to send control signals in order to control the current delivered from the power source to the pair of electrodes in a continuous stimulation pattern.
  • 24. The stimulation apparatus of claim 23, wherein the first device further comprises the controller.
  • 25. The stimulation apparatus of claim 23, wherein the second device further comprises the controller.
CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of U.S. Provisional Application No. 63/513,256 filed on Jul. 12, 2023, the contents of which are hereby incorporated by reference.

Provisional Applications (1)
Number Date Country
63513256 Jul 2023 US