GB2608177A

GB2608177A - Apparatus and related methods for applying an electromagnetic force to stimulate the vagus nerve

Info

Publication number: GB2608177A
Application number: GB2109184.8A
Authority: GB
Inventors: Yu Yufang; Oxley John; Pampapathi Rajesh; Sinkevich Yauhen
Original assignee: Brain Control Co Ltd
Current assignee: Brain Control Co Ltd
Priority date: 2021-06-25
Filing date: 2021-06-25
Publication date: 2022-12-28
Also published as: GB202114177D0; GB202109184D0

Abstract

An apparatus 100 suitable for applying a transdermal electromagnetic force to stimulate a branch of the vagus nerve; and a method of using the apparatus 100 to stimulate the vagus nerve. The apparatus 100 has a power source 114; a housing 112 with means for attachment to a user; and an electromagnetic coil/wire 110 positioned in the housing 112 and connected to the power source 114 such that when the coil 110 is energised by the power source 114, it transmits an electromagnetic flux. The apparatus 100 also has a controller 118 for receiving and analysing user data, such as user preferences or settings received from an external device 200; and, based on this data, regulating the power supplied to the coil/wire 114. The controller 118 can control features of the transmitted electromagnetic wave such as frequency, intensity, and waveform; and can communicate with an external device (200, Fig. 3) via a wire or a wireless transceiver.

Description

Intellectual Property Office Application No G132109184.8 RTM Date:9 December 2021 The following terms are registered trade marks and should be read as such wherever they occur in this document: "Bluetooth", "Wi-FT", "WiMAX" Intellectual Property Office is an operating name of the Patent Office www.gov.uk/ipo Title: Apparatus and Related Methods for Applying an Electromagnetic Force to Stimulate the Vagus Nerve

Field of Invention.

The present invention relates generally to apparatus and methods for stimulating the Vagus nerve. More specifically, the present invention relates to apparatus and methods for applying an electromagnetic force to stimulate the Vagus nerve.

Background

The Vagus nerve is part of the autonomic nervous system (ANS), specifically the parasympathetic branch, and is involved in regulating many of the involuntary processes of the body, such as heart rate, breathing, digestion and immune system response. It is the longest cranial nerve, extending from the base of the brain, branching to parts of the face, ear, and neck before passing into the core of the body and connecting to practically all the major organs. It has the function of slowing bodily processes, and stimulation of the nerve is known to promote relaxation and healing.

Declining activity in the Vagus nerve causes bodily imbalances that can lead to various minor health issues, particularly for the elderly, such as mood changes, disruption of sleep patterns, problems with digestion and immune system strength, and reduced capacity for exercise. Changes in the activity of the Vagus nerve have also been associated with the onset of dementia and general cognitive decline. In extreme cases, medics will implant an electrical simulator to directly target the major branch of the Vagus nerve that passes down the neck.

Evidence shows that less serious cases of declining Vagus nerve activity can be greatly mitigated by stimulating a branch of the nerve which extends into the ear; this is known as the auricular branch of the nerve, and the tragus of the ear presents convenient access to the nerve.

Recent studies have further shown that stimulation of the nerve in healthy individuals can improve memory performance, because stimulation activates regions of the brain which are important in the consolidation memories. Scientists and medics are thus increasingly recommending the use of vagal nerve stimulation as a path to healthier ageing.

Stimulation of the vagus nerve using transdermal and implanted micro-electrical pulses is already an established method, however side effects can include skin irritation and electrical burns. Impedance levels vary between subjects and can cause dosage and usability problems. A less invasive, more personalized method of Vagus nerve stimulation would be desirable.

It is within this context that the present invention is provided. Summary The present disclosure provides an apparatus for applying a transdermal electromagnetic force to stimulate a branch of the Vagus nerve of a user based on received user data. The user data can include user preferences and settings received via an external device and/or biomarker data from one or more sensors. Related systems and methods for using the apparatus are also provided.

Replacing traditional electrical stimulation with an application of a transdermal electromagnetic force, [ME, which is controlled based on received user data resolves the aforementioned issues of skin irritation, electrical burns, and dosage issues. The applied [ME produces an electric field and flux in a target region of the subject ear or neck area to stimulate the vagus nerve. [ME delivers stimulation efficiently through the skin and causes no discomfort from sensory receptors.

Thus, according to one aspect of the present disclosure there is provided an apparatus for applying an electromagnetic force to the Vagus nerve, the apparatus comprising: a power source; a housing, the housing comprising attachment means for securing to user; at least one electromagnetic coil or wire connected to the power source and disposed within the housing such that when the housing is secured to the user and the at least one electromagnetic coil or wire is energised by the power source, a transdermal electromagnetic flux is applied to a Vagus nerve branch.

The apparatus further comprising a controller, the controller being configured to receive user data, analyse the user data and, based on the user data, regulate power supply from the power source to the at least one electromagnetic coil or wire.

In one embodiment, the controller comprises a wireless transceiver for communicating with an external device.

In other embodiments, the controller has a wired connection to an external device.

In some embodiments, the user data comprises a set of one or more user preferences or settings received from an external device.

In some embodiments, the apparatus comprises one or more biomarker sensors in communication with the controller, the biomarker sensors being one of an Electroencephalography, EEG, sensor, an electrocardiogram, ECG, sensor, a Galvanic Skin Response, GSR, sensor, heart rate sensor, blood flow sensor, and blood chemistry sensor.

In such embodiments, the user data comprises feedback from the one or more biomarker sensors.

Some embodiments may involve a combination of biomarker feedback and user preferences and settings as the user data.

In some embodiments, the controller is configured to, based on the user data, control one or more settings from: a frequency, a phase duration, an intensity, an offset, and a waveform shape of the electromagnetic force emitted by the coil or wire.

Furthermore, the controller may be configured with a machine learning algorithm to determine the one or more settings based on the user data.

In some embodiments, the apparatus further comprises one or more electromagnetic shielding plates for controlling the electromagnetic flux emitted by the coil or wire.

In some embodiments, the housing is in the form of a clip, and the attachment means comprises a hinge joint of the clip.

In some embodiments, the apparatus comprises first and second electromagnetic coils or wires disposed on opposing sides of the clip.

According to another aspect of the present disclosure, there is provided a method of using the apparatus of any preceding claim to stimulate the Vagus nerve, the method comprising the steps of: securing the apparatus to a body part of the user via the attachment means, the body part being one of the tragus of the ear, the cymba-conchae of the ear, or the neck; inputting one or more settings or personal preferences into the apparatus via an external apparatus, or allowing the device to collect biomarker data for the user; and receiving a transdermal electromagnetic force from the one or more coils or wires of the apparatus, the transdermal electromagnetic force stimulating a branch of the Vagus nerve.

Brief Description of the Drawings

Various embodiments of the invention are disclosed in the following detailed description and accompanying drawings.

FIG.1 illustrates an isometric view of an example configuration of the disclosed apparatus.

FIG.2 illustrates the configuration of FIG.1 with an example configuration of the internal components shown.

FIG.3 illustrates the example configuration worn in place on the tragus of a user and in wireless communication with an external device.

FIG.4 illustrates an example network architecture over which user data for wireless implementations of the disclosed device can be transmitted.

Common reference numerals are used throughout the figures and the detailed description to indicate like elements. One skilled in the art will readily recognize that the above figures are examples and that other architectures, modes of operation, orders of operation, and elements/functions can be provided and implemented without departing from the characteristics and features of the invention, as set forth in the claims.

Detailed Description and Preferred Embodiment

The following is a detailed description of exemplary embodiments to illustrate the principles of the invention. The embodiments are provided to illustrate aspects of the invention, but the invention is not limited to any embodiment. The scope of the invention encompasses numerous alternatives, modifications and equivalent; it is limited only by the claims.

Numerous specific details are set forth in the following description in order to provide a thorough understanding of the invention. However, the invention may be practiced according to the claims without some or all of these specific details. For the purpose of clarity, technical material that is known in the technical fields related to the invention has not been described in detail so that the invention is not unnecessarily obscured.

The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. As used herein, the term "and/or" includes any combinations of one or more of the associated listed items. As used herein, the singular forms "a," "an," and "the" are intended to include the plural forms as well as the singular forms, unless the context clearly indicates otherwise. It will be further understood that the terms "comprises" and/or "comprising," when used in this specification, specify the presence of stated features, steps, operations, elements, and/or components, but do not preclude the presence or addition of one or more other features, steps, operations, elements, components, and/or groups thereof.

The present disclosure provides examples of a specific implementation of the disclosed apparatus for applying a transdermal [ME to a target region of a user to stimulate a branch of the Vagus nerve.

Referring to FIG.1, an isometric view of an example configuration of the disclosed apparatus 100 is shown.

In the present example, the apparatus 100 is a self-contained smart device in the form a clip, comprising a first housing 102, a second housing 104, and an attachment means 106 in the form of a hinge which connects the opposing housing pieces 102 and 104. In such self-contained examples the apparatus 100 generally has wireless capabilities for communicating with an external device such as a smartphone, or a set of biometric sensors connected to a smart processor to enable the device to operate independently, or both.

In other examples not illustrated here the device may be wired to an external device for receiving input.

In the illustrated example, the [ME coil or wire of the apparatus 100 is placed in the end of the tip of housing section 102. Generally, the housing sections 102 and 104 may be made of an insulator material to both protect the user from the electrical currents of the internal components and to shape the [ME field generated by the coil. A portion of non-insulator material 108 is embedded into the tip of the housing section 102 to direct the [ME field.

In some examples, a similar or identical configuration of [ME coil or wire and non-insulator material may also be disposed inside the tip of the opposing housing section 104.

In use, the tips of the housing sections may be placed either side of a target region of the user's body to direct the [ME flux from the one or more coils or wires at a branch of the Vagus nerve, for example the clip may be placed onto the tragus of the ear, the cymba-concha of the ear, or an appropriate portion of the user's neck. The hinge 106 may be configured to apply a pressure to keep the clip in place.

Referring to FIG.2, the internal components of the housing section 102 are shown.

As can be seen, each housing section is hollow, and may hold a variety of electrical components. In this example, only the components of housing section 102 are shown.

The internal components of the apparatus always comprise at least one EMF coil or wire 108 configured to generate an electromagnetic field to be applied to a target region of a body. The coil or wire 110 may be an inductive EMF coil or wire. Induced EMF is the production of voltage in a coil because of the change in a magnetic flux through a coil. An EMF can be induced in two ways, i.e., when an electric conductor is kept in a moving magnetic field or when the electric conductor is constantly moving within a static magnetic field. Many electrical components such as motors, galvanometer, generators, transformers, etc., work based on the principle of induced EMF and induced EMF coils are well-known technology.

The coil 110 is in the present example connected to a controller circuit board 112 that comprises a power source 114, a set of biomarker sensors 116, and an MCU microcontroller 118 configured to receive information from the biomarker sensors 116 and regulate power flow between the power source 114 and the coil 110 in a number of ways. The microcontroller 118 may further comprise a wireless transceiver for communicating with one or more external devices.

Shielding plates 120 may also be positioned at various points surrounding the coil 110 to control the shape of the electromagnetic field produced when it is energised, preventing EMF flux from being directed into the user's skull, for example.

The biomarker sensors 116 can include any one of an Electroencephalography, EEG, sensor (for example, to measure Vagus nerve action potentials), an electrocardiogram, ECG, sensor, a Galvanic Skin Response, GSR, sensor, and a heart rate sensor. Other sensors such as skin temperature sensors may also be included. Sensors may also be included to determine breathing rate and blood pressure. One example of a multi-functional sensing technique for measuring blood flow and composition that may also be used is functional near infrared spectroscopy (fNIRS).

The purpose of the apparatus 100 is to induce or alter a mental state of a user, for wellness benefits such as relaxation, better sleeping, improved vagal tone. There may also be future medical applications e.g. reduced anxiety, IBS treatment, arthritis management.

Feedback from the one or more biomarker sensors provides information on the current mental state of the user to which the device is attached. This data can be used, alone or in conjunction with user data received via the wireless transceiver, to determine how to regulate the power to the coil 110 to alter or induce a mood for the user. The system can also monitor changes in biomarker activity and adapt the stimulation accordingly.

For example, based on the received biomarker feedback and/or received data, the microcontroller 118 may control one or more settings for the [ME coil including but not limited to: a frequency, a phase duration, an intensity (Tesla level at the target region), an offset, and a waveform shape (for example -sine, square, monophasic).

The use of such feedback from the biomarker sensors 116 enables the applied [ME force to be personalised to the user, since the same parameters will not get the same response in every subject. Based on the desired outcome, the device will have a parameter range that it will operate within. It will try to find the optimal parameter settings for each subject.

Where there is known correlation between a change in [ME parameters and a change in biomarkers, the apparatus 100 will automatically adjust the parameters based on the feedback data. For example, stimulation with EMF frequency of 25Hz has been shown to increase heart rate variability. Heart rate variability is a known biomarker for autonomic health which the Vagus nerve regulates. The subject's HRV can be measured in real time. After applying bursts of [ME in a range around this frequency and measuring the HRV, the apparatus can find the most effective frequency for the subject.

As mentioned previously, the apparatus may further be configured to communicate wirelessly with an external device to receive additional user data such as user preferences, user instructions, settings and indications of a user's mood. The external device may even include a dedicated software application with an interface for a user to enter such information.

Referring to FIG.3 the apparatus 100 is shown clipped in place on the tragus of a user and in wireless communication with an external device 200.

Communication with the wireless device 200 may provide a number of functions. In some examples, the device 200 operates a dedicated application software where a user can set a desired outcome (reason for using the apparatus) such as for example to "be less stressed".

The device 200 may also provide a set of questions to determine a current mood or general physical characteristics of the user which cannot be measured directly by sensors as well as an interface for inputting information on sensations and perceptions experienced by the user.

In one example, the application asks three structured questions: (1) How do you feel? (2) How do you want to feel? (3) How long have we got? The user's answers will help determine the parameters to apply to the [ME coil. In this specific example, the first question is useful to combine with the sensor data. The second helps choose a stimulation pattern to apply, and the third controls the stimulation duration.

Relevant physical attributes may allow the controller 118 to more accurately calculate intensity thresholds and parameters to apply for powering the [ME coil. For example, the microcontroller 118 may use a lookup table for parameter initialisation based on entered age, sex, height and weight values.

In some cases the apparatus 100 may communicate with multiple external devices, some of which may comprise sensor data of their own. Some of the sensor data can thus be acquired from other devices e.g. heart rate data from a smart watch on the user's wrist.

In some examples, the collected data may be fed into a machine learning algorithm to find the subject-specific stimulation settings per desired outcome.

The external device may also provide the option for a user to directly control the [ME coil parameters if desired.

In some examples, all data is collected and analysed by machine learning algorithms to further optimise the stimulation process.

The external device need not necessarily be a smartwatch or smartphone, and the processing operations described herein need not necessarily all take place on the microcontroller 118.

Referring to FIG.4 an example network architecture 300 is shown over which user data for wireless implementations of the disclosed apparatus can be transmitted.

One or more of the operations and calculations described herein may be performed by a cloud infrastructure 302 comprising one or more servers and databases 304.

The cloud infrastructure 302 may for example comprise a database configured to receive and store user data for a plurality of user accounts and a set of servers or nodes configured to enact the operations as disclosed herein.

The cloud infrastructure 302 is configured to communicate with a set of client devices 310 by various means over the illustrated network architecture. The illustrative client devices 310 include devices configured to communicate with the cloud infrastructure 302 via a communications tower 306. These devices may include but are not limited to a smartphone 312, a laptop 314, and a tablet computer 316.

Additional client devices configured to communicate with the cloud infrastructure 302 via a networked computer modem 308 include but are not limited to a smart display 318 and a second laptop 320. Some of the connections may be wired connections, such as the connection between the smart display 318 and the networked computer modem 308.

Any one of the client devices 310 may be operationally coupled to a wide area network (WAN) such as the Internet with a wireless connection. The wireless clients may be communicatively coupled to the WAN via a Wi-Fi (or Bluetooth) access point that is communicatively coupled to a modem, which is communicatively coupled to the WAN. The wireless clients may also be communicatively coupled to the WAN using a proprietary carrier network that includes illustrative communication tower 306.

While a specific set of client devices are illustrated in the architecture of FIG.4 the client devices may in fact be any suitable device. For example, client devices could include a mobile handset, mobile phone, wireless phone, portable cell phone, cellular phone, portable phone, a personal digital assistant (PDA), a tablet, a portable media device, a wearable computer, or any type of mobile terminal which is regularly carried by an end user and has all the elements necessary for operation in a wireless communication system. The wireless communications include, by way of example and not of limitation, CDMA, WCDMA, GSM, UMTS, or any other wireless communication system such as wireless local area network (WLAN), Wi-Fi or WiMAX.

Each client device 310 may be associated with or "logged in" to a user profile in order to operate within the disclosed system and method, and further configured to send requests, upload user data, and generally interact with the cloud infrastructure 302 via a user interface displayed on the device.

It should be understood that the operations described herein may be carried out by any processor. In particular, the operations may be carried out by, but are not limited to, one or more computing environments used to implement the method such as a data center, a cloud computing environment, a dedicated hosting environment, and/or one or more other computing environments in which one or more assets are used by the method re implemented; one or more computing systems or computing entities used to implement the method; one or more virtual assets used to implement the method; one or more supervisory or control systems, such as hypervisors, or other monitoring and management systems, used to monitor and control assets and/or components; one or more communications channels for sending and receiving data used to implement the method; one or more access control systems for limiting access to various components, such as firewalls and gateways; one or more traffic and/or routing systems used to direct, control, and/or buffer, data traffic to components, such as routers and switches; one or more communications endpoint proxy systems used to buffer, process, and/or direct data traffic, such as load balancers or buffers; one or more secure communication protocols and/or endpoints used to encrypt/decrypt data, such as Secure Sockets Layer (SSL) protocols, used to implement the method; one or more databases used to store data; one or more internal or external services used to implement the method; one or more backend systems, such as backend servers or other hardware used to process data and implement the method; one or more software systems used to implement the method; and/or any other assets/components in which the method is deployed, implemented, accessed, and run, e.g., operated, as discussed herein, and/or as known in the art at the time of filing, and/or as developed after the time of filing.

As used herein, the terms "computing system", "computing device", and "computing entity", include, but are not limited to, a virtual asset; a server computing system; a workstation; a desktop computing system; a mobile computing system, including, but not limited to, smart phones, portable devices, and/or devices worn or carried by a user; a database system or storage cluster; a switching system; a router; any hardware system; any communications system; any form of proxy system; a gateway system; a firewall system; a load balancing system; or any device, subsystem, or mechanism that includes components that can execute all, or part, of any one of the processes and/or operations as described herein.

As used herein, the terms computing system and computing entity, can denote, but are not limited to, systems made up of multiple: virtual assets; server computing systems; workstations; desktop computing systems; mobile computing systems; database systems or storage clusters; switching systems; routers; hardware systems; communications systems; proxy systems; gateway systems; firewall systems; load balancing systems; or any devices that can be used to perform the processes and/or operations as described herein.

As used herein, the term "computing environment" includes, but is not limited to, a logical or physical grouping of connected or networked computing systems and/or virtual assets using the same infrastructure and systems such as, but not limited to, hardware systems, software systems, and networking/communications systems. Typically, computing environments are either known environments, e.g., "trusted" environments, or unknown, e.g., "untrusted" environments. Typically, trusted computing environments are those where the assets, infrastructure, communication and networking systems, and security systems associated with the computing systems and/or virtual assets making up the trusted computing environment, are either under the control of, or known to, a party.

Unless specifically stated otherwise, as would be apparent from the above discussion, it is appreciated that throughout the above description, discussions utilizing terms such as, but not limited to, "activating", "accessing", "adding", "applying", "analyzing", "associating", "calculating", "capturing", "classifying", "comparing", "creating", "defining", "detecting", "determining"" "eliminating", "extracting", "forwarding", "generating", "identifying", "implementing", "obtaining", "processing", "providing", "receiving", "sending", "storing", "transferring", "transforming", "transmitting", "using", etc., refer to the action and process of a computing system or similar electronic device that manipulates and operates on data represented as physical (electronic) quantities within the computing system memories, resisters, caches or other information storage, transmission or display devices.

Those of skill in the art will readily recognize that the algorithms and operations presented herein are not inherently related to any particular computing system, computer architecture, computer or industry standard, or any other specific apparatus. Various general purpose systems may also be used with programs in accordance with the teaching herein, or it may prove more convenient/efficient to construct more specialized apparatuses to perform the required operations described herein. The required structure for a variety of these systems will be apparent to those of skill in the art, along with equivalent variations. In addition, the present invention is not described with reference to any particular programming language and it is appreciated that a variety of programming languages may be used to implement the teachings of the present invention as described herein, and any references to a specific language or languages are provided for illustrative purposes only and for enablement of the contemplated best mode of the invention at the time of filing.

Unless otherwise defined, all terms (including technical terms) used herein have the same meaning as commonly understood by one having ordinary skill in the art to which this invention belongs. It will be further understood that terms, such as those defined in commonly used dictionaries, should be interpreted as having a meaning that is consistent with their meaning in the context of the relevant art and the present disclosure and will not be interpreted in an idealized or overly formal sense unless expressly so defined herein.

The disclosed embodiments are illustrative, not restrictive. While specific configurations of the apparatus for Vagus nerve stimulation have been described in a specific manner referring to the illustrated embodiments, it is understood that the present invention can be applied to a wide variety of solutions which fit within the scope and spirit of the claims. There are many alternative ways of implementing the invention.

It is to be understood that the embodiments of the invention herein described are merely illustrative of the application of the principles of the invention. Reference herein to details of the illustrated embodiments is not intended to limit the scope of the claims, which themselves recite those features regarded as essential to the invention.

Claims

Claims What is claimed is: 1. An apparatus for applying an electromagnetic force to the Vagus nerve, the apparatus comprising: a power source; a housing, the housing comprising attachment means for securing to user; at least one electromagnetic coil or wire connected to the power source and disposed within the housing such that when the housing is secured to the user and the at least one electromagnetic coil or wire is energised by the power source, a transdermal electromagnetic flux is applied to a Vagus nerve branch; a controller, the controller being configured to receive user data, analyse the user data and, based on the user data, regulate power supply from the power source to the at least one electromagnetic coil or wire.
2. Apparatus according to claim 1, wherein the controller comprises a wireless transceiver for communicating with an external device.
3. Apparatus according to claim 1, wherein the controller has a wired connection to an external device.
4. Apparatus according to claim 2 or claim 3, wherein the user data comprises a set of one or more user preferences or settings received from an external device.
5. Apparatus according to claim 1, wherein the apparatus comprises one or more biomarker sensors in communication with the controller, the biomarker sensors being one of an Electroencephalography, EEG, sensor, an electrocardiogram, ECG, sensor, a Galvanic Skin Response, GSR, sensor, heart rate sensor, blood flow sensor, and blood chemistry sensor.
6. Apparatus according to claim 5, wherein the user data comprises feedback from the one or more biomarker sensors.
7. Apparatus according to claim 1, wherein the controller is configured to, based on the user data, control one or more settings from: a frequency, a phase duration, an intensity, an offset, and a waveform shape of the electromagnetic force emitted by the coil or wire.
8. Apparatus according to claim 7, wherein the controller is configured with a machine learning algorithm to determine the one or more settings based on the user data.
9. Apparatus according to claim 1, wherein the apparatus further comprises one or more 1:3 electromagnetic shielding plates for controlling the electromagnetic flux emitted by the coil or wire.
10. Apparatus according to claim 1, wherein the housing is in the form of a clip, and the attachment means comprises a hinge joint of the clip.
11. Apparatus according to claim 10, wherein the apparatus comprises first and second electromagnetic coils or wires disposed on opposing sides of the clip.
12. A method of using the apparatus of any preceding claim to stimulate the Vagus nerve, the method comprising the steps of: securing the apparatus to a body part of the user via the attachment means, the body part being one of the tragus of the ear, the cymba-conchae of the ear, or the neck; inputting one or more settings or personal preferences into the apparatus via an external apparatus, or allowing the device to collect biomarker data for the user; and receiving a transdermal electromagnetic force from the one or more coils or wires of the apparatus, the transdermal electromagnetic force stimulating a branch of the Vagus nerve.