NO20240902A1 - A wearable electronic stimulating device, a method for operating a wearable electronic stimulating device and a system for operating a wearable electronic stimulating device - Google Patents

Description

[0001] A wearable electronic stimulating device, a method for operating a wearable electronic stimulating device and a system for operating a wearable electronic stimulating device

[0002] Technical field

[0004] The present disclosure relates to a wearable electronic stimulating device, a method for operating a wearable electronic stimulating device and a system for operating a wearable electronic stimulating device. More specifically, the disclosure relates to a wearable electronic stimulating device, a method for operating a wearable electronic stimulating device and a system for operating a wearable electronic stimulating device as defined in the introductory parts of the independent claims.

[0006] Background art

[0008] Chronic pain is a major societal problem with no effective treatment, affecting approximately 30% of the adult population globally. Nearly 80% receive no pain relief from any available treatments including medications. It is estimated that 47,5% of all long-term sick leave is caused by chronic pain.

[0010] In Norway alone 1.5 million people struggle with chronic pain. Of these, approximately 160.000 have severe pain without any viable long-term treatment options. The main problem is that despite a vast variety of therapeutic options, nearly 50 % do not get any pain relief from medications or any other available pain therapy.

[0012] The lack of effective treatments has severe consequences, as such, new options for pain relieve are highly sought after and commercially viable.

[0014] A problem with the solutions of the prior art is that only 2:10 get any relief from pain medications, and the rest only get negative side-effects, surgery does not work, and physical therapy and psychology only helps a few where physical and cognitive change is slow, challenging and expensive. Patients do not want to take drugs because of side-effects and addiction.

[0015] In the search for lasting pain relief, stimulating the vagus nerve (Vagus Nerve Stimulation - VNS) has been seen as a viable option. The Vagus nerve (the 10th cranial nerve) innervates multiple internal organs and integrates sensory, motor, and autonomic information by four vagal nuclei.

[0017] The main obstacle causing VNS to not be widely implemented is that surgical implementation is expensive and dangerous. However, non-invasive VNS delivery systems do not require surgery and these systems have improved the safety and tolerability of VNS, making it more accessible and feasible. One such non-invasive system, Transcutaneous Vagus Nerve Stimulation (t-VNS), uses the auricular branch of the vagus nerve, which extends to the outer ear. This means that the nerve branch can be stimulated through the skin (transcutaneous) with electrical impulses. Intensity, pulse duration and frequency of the t-VNS stimulation are targeted to induce signaling from the A-β fibers of this auricular branch.

[0018] Auricular nerve fibers project to brain structures, which are involved in the descending inhibitory modulation of pain.

[0020] However, current stimulators have low hit ratio with limiting efficiency and usability. Currently there are no stimulators in the marketplace that provide a sufficiently efficient product for pain relief. Some inadequate products are offered at a high price range.

[0022] The problem is that prior art devices lack adaptability, flexibility and efficiency, is cumbersome to use/ill fitted and expensive.

[0024] There is thus a need for improved device, method and system for relieving pain sensation.

[0026] Summary

[0028] It is an object of the present disclosure to mitigate, alleviate or eliminate one or more of the above-identified deficiencies and disadvantages in the prior art and solve at least the above-mentioned problem. According to a first aspect there is provided a wearable electronic stimulating device comprising: a distal portion comprising one or more distal electrode modules, a proximal portion comprising or being remotely connected to one or more of: a control module and a power source for powering the control module and the distal electrode modules, the distal portion having a cylindrical tapering towards the distal end resilient C-shape configured to fit inside the cymba concha of an ear when the wearable electronic stimulating device is in use, for providing contact towards the inside curve of the antihelix and the cymba concha of the ear, and each distal electrode module having an outer curved surface adapted to, and arranged in, the outside surface of the distal portion. The configuration of the distal electrode modules are such that they are positioned for being brought in contact with the cymba concha of an ear when the wearable electronic stimulating device is in use.

[0030] The resilient C-shape may be bendable to adapt its shape to fit in many various individual forms of wearers ear.

[0032] An advantage of the device according to present disclosure is that it provides optimal contact between the electrode modules and the cymba concha of an ear of a user when in use. It even adapts to various forms of the ear of a user when in use.

[0034] A further advantage of the device according to the present disclosure is that the device may be self-sustained in that it may comprise its own power and controller, and hence does not involve handling multiple entities and cabling. The power source may be rechargeable, and the device may comprise a communication module for wireless communication to e.g. a Smartphone.

[0036] According to some embodiments the proximal portion of the wearable electronic stimulating device comprises one or more proximal electrode modules, the proximal electrode module being controlled by the control module, and the one or more proximal electrode modules having an outer curved surface adapted to, and arranged in, the outside surface of the proximal portion at a position for being brought in contact with the cavum concha of an ear when the wearable electronic stimulating device is in use.

[0038] The electrode modules have therefore an optimal form to optimize the contact area with the cavum concha.

[0040] According to some embodiments the cylindrical tapering of the distal portion is formed with an outside curved form intended for maximizing the contact with the cymba concha of a user’s ear.

[0041] A good contact along the cymba concha secures a better gripping force enabling the wearable electronic stimulating device to remain inside the cymba concha of a user’s ear unaffected by movement and activities done by the user, and thus it also provides optimal contact for the distal electrode modules.

[0043] According to some embodiments any of the electrode modules are electrically paired with another of the electrode modules, and the control module is configured to output a controlled voltage and/or current signal over the one or more paired electrode modules.

[0045] This increase the possibilities to alter and format the signal pattern and the direction and location of the signals to be sent. The strength and pattern of the signal may also be outputted according to a predefined scheme.

[0047] According to some embodiments the control module is configured to control the pairing configuration of the electrode modules.

[0049] According to some embodiments the control module is configured to output the predefined current over the electrodes at a predefined pattern and polarity comprising predefined pairing of the electrodes.

[0051] Thus, enabling both in situ dynamic changing and predefined configuration of pairing configuration and signal patterns to be executed.

[0053] According to some embodiments the wearable comprises: a heart rate sensor.

[0055] This enables dynamic adaption of the pairing and signal pattern/strength to be customized to a user reaction.

[0057] According to some embodiments the heart rate sensor is a Photoplethysmography, PPG, sensor, and the sensor is arranged behind a sensor window arranged in the proximal portion of the wearable electronic stimulating device.

[0059] According to some embodiments one or more of the electrode modules outer surface the wearable comprises an array of multiple spikes.

[0061] A good contact is secured with the ear skin surface.

[0062] According to some embodiments the spikes has a height h between 0,1 and 0,9 mm, and more advantageous between 0,2 and 0,6 mm, and most advantageous between 0,3 and 0,5 mm.

[0064] The form of the spikes is advantageously solving the trade-off of being comfortable enough for the user to use the wearable electronic stimulating device, and for the signals to be properly transferred to the ear.

[0066] According to some embodiments the spikes are arranged with at least 0,2 mm distance between spikes, or more advantageous with at least 0,4 mm distance between spikes, or most advantageous more than 0,6 mm distance between spikes.

[0068] According to some embodiments the spikes has a conical tapering towards the top, and the cone top of the spikes are configured to be able to penetrate the epidermal stratum corneum or the outer protective layer of the skin of a user’s ear.

[0070] According to some embodiments the number of spikes in any of the distal electrodes are more than 20, or more advantageous more than 30,or most advantageous more than 40.

[0072] According to some embodiments the number of spikes in any of the proximal electrodes are more than 40, or more advantageous more than 60,or most advantageous more than 80.

[0074] According to some embodiments the wearable comprises one or more sensors, being any of: temperature sensor, magnetic and/or electric field sensor, humidity sensor, pressure sensor, accelerometer and gyroscope sensor, electrodermal activity and heart rate sensor.

[0076] According to some embodiments the control module is further configured to use input from the sensors to set the output voltage level over the electrode module pairs.

[0078] According to some embodiments the distal portion is a replaceable portion the wearable comprises a distal connector device and electrical connectors for quick lock/release from the proximal portion, wherein the proximal portion the wearable comprises a corresponding proximal connector device and electrical connectors for cooperating with the distal connector device and electrical connectors.

[0079] The ability to be replaced ensures that the portion most likely to wear out, easily can be replaced. This is also a feature ensuring that a variation of distal portion C-shapes may be shipped, and user can choose which fits the best. It is also a way to solve variations in electrode module characteristics and positions, when distal portion C-shapes have different configurations and may be changed to achieve variations in the properties of the distal portion C-shape when in use.

[0081] According to some embodiments the electrical connectors comprise the distal and proximal connector device.

[0083] The advantage of this feature is that there are less components in play for facilitating connection and signal transfer.

[0085] According to some embodiments the connector devices comprise one or more of: a magnet, a spring loaded snaplock, a bayonet type connector, a threaded type connector, male/female alignment pin, and Registered jack, RJ.

[0087] According to some embodiments the proximal portion further comprises a speaker device arranged for outputting sound, the speaker device being electrically connected to and controlled by the control module.

[0089] This provides for using the device in combination with audio treatment. Another functionality of the speaker device is to output music and/or speech , such as for. example use instructions, status and progress, or other.

[0091] According to some embodiments the wearable electronic stimulating device comprises a communication device for enabling communication between the electrode control module and a remote control module.

[0093] According to some embodiments the electrodes modules and the distal and proximal portion provides a waterproof outer surface, wherein the electronic components inside the distal and proximal portions are connected in a dry environment.

[0095] According to a second aspect there is provided a method for operating a wearable electronic stimulating device, comprising the steps: providing a wearable electronic stimulating device according to any of the first aspect, providing a current output pattern for the control module, and arranging the wearable electronic stimulating device for outputting the voltage/current according to the provided output pattern.

[0097] According to a third aspect there is provided a system for operating a wearable electronic stimulating device comprising: one or more wearable electronic stimulating device according to any of the first aspect, and a remote control module for controlling the one or more wearable electronic stimulating device.

[0099] Effects and features of the second and third aspects are to a large extent analogous to those described above in connection with the first aspect. Embodiments mentioned in relation to the first aspect are largely compatible with the second and third aspects.

[0101] The present disclosure will become apparent from the detailed description given below. The detailed description and specific examples disclose preferred embodiments of the disclosure by way of illustration only. Those skilled in the art understand from guidance in the detailed description that changes and modifications may be made within the scope of the disclosure.

[0103] Hence, it is to be understood that the herein disclosed disclosure is not limited to the particular component parts of the device described or steps of the methods described since such device and method may vary. It is also to be understood that the terminology used herein is for purpose of describing particular embodiments only, and is not intended to be limiting. It should be noted that, as used in the specification and the appended claim, the articles "a", "an", "the", and "said" are intended to mean that there are one or more of the elements unless the context explicitly dictates otherwise. Thus, for example, reference to "a unit" or "the unit" may include several devices, and the like. Furthermore, the words "comprising", "including", "containing" and similar wordings does not exclude other elements or steps.

[0105] Terminology

[0107] Electrodermal activity (EDA; sometimes known as galvanic skin response, or GSR) refers to the variation of the electrical conductance of the skin in response to sweat secretion. This can be done for example with EDA sensors that measure the electrical signal recorded by electrodes applied to the skin.

[0108] Abbreviations

[0109] VNS - Vagus nerve stimulation

[0110] iVNS - Invasive vagus nerve stimulation

[0111] aVNS - Auricular vagus nerve stimulation

[0112] tVNS - Transcutaneous vagus nerve stimulation

[0113] Brief descriptions of the drawings

[0114] The above objects, as well as additional objects, features and advantages of the present disclosure, will be more fully appreciated by reference to the following illustrative and non-limiting detailed description of example embodiments of the present disclosure, when taken in conjunction with the accompanying drawings (some of which includes contour lines for better understanding the form of the devices).

[0115] Figure 1 illustrates the structure of the vagus nerve system of a human body Figure 2A illustrates a typical sectioning of a human ear showing different regions according to historical ear acupuncture

[0116] Figure 2B illustrates various sections of a human ear

[0117] Figure 2C illustrates major nerve paths in an ear

[0118] Figure 3A illustrates a first embodiment of the device according to present disclosure Figure 3B illustrates the device from Fig.2A arranged in a user’s ear

[0119] Figure 3C illustrates a cross-section view of the distal portion of the C-shape Figure 3D illustrates the proximal part of the device seen from the connecting surface side highlighting the arc-form of the electrode module.

[0120] Figure 3E illustrates the distal part of the device seen from the connecting surface side

[0121] Figure 3F illustrates a detail of the distal portion highlighting the arc-form of the electrode modules

[0123] Figure 3G illustrate the connecting members of the proximal portion interacting with the distal portion

[0125] Figure 3H illustrates the PCB and components arrangement of the proximal portion interacting with the distal portion

[0127] Figure 3I shows an exploded view of the components of one embodiment of the proximal portion

[0129] Figure 3J shows an exploded view of the components of one embodiment of the distal portion

[0131] Figure 4A-4D illustrates the device according to a second embodiment of present disclosure seen from front, oblique, above and below respectively

[0133] Figure 5 shows modules of a high-level system according to present disclosure

[0134] Figure 6 shows a use scenario of present disclosure

[0136] Figure 7 illustrates how signal pulses may be modified/defined according to present disclosure

[0138] Detailed description

[0140] The present disclosure will now be described with reference to the accompanying drawings, in which preferred example embodiments of the disclosure are shown. The disclosure may, however, be embodied in other forms and should not be construed as limited to the herein disclosed embodiments. The disclosed embodiments are provided to fully convey the scope of the disclosure to the skilled person.

[0141] Figure 1 shows the structure of the vagus nerve system of a human body. The vagus nerve system is the longest collection of nerves in the body. It passes information back and forth between the brain and the largest organs such as the heart, lungs and gut. The Vagus nerve represents the main component of the nervous system. Through stimulation it is possible to manipulate the nervous system to create desired health benefits. In the search for lasting pain relief, and since patients do not want to take drugs because of side-effects and addiction, because surgery does not work, and physical therapy only helps a few, stimulating the vagus nerve (VNS) has long been seen as a viable option for such pain relief.

[0143] Clinical studies indicate that acupuncture has shown some effects providing pain relief, and figure 2B illustrates a typical sectioning of a human ear showing different regions according to historical ear acupuncture.

[0145] The auricular branch of the vagus nerve 10 is found in the outer ear, and as such an optimal site for stimulation where you may hit the auricular branch of the vagus nerve with precision. Clinical studies show that the highlighted areas in figure 2B are optimal sites of stimulation.

[0147] A 4-year trial conducted by the inventors of present disclosure was performed using prior art methods, showing first evidence of t-VNS relieving pain in Fibromyalgia syndrome (FMS). Trial data revealed three essential limitations in the t-VNS apparatus pertaining to stimulation areas, strength and comfort, reducing its ability to alleviate pain.

[0149] The present disclosure reveals that the stimulation of multiple points of the vagus nerve in the ear will increase efficiency. This may be caused by the fact that the nature and location of where the vagus nerve is most prominent differs from one to another individual.

[0151] The present disclosure discloses a device, method and system for non-invasive activation of the auricular branch of the vagus nerve 10. The novel device and method provide the possibility to optimize the hit rate of the pain relief by stimulating several areas indicated by the green circles in figure 2A.

[0153] The first aspect of this disclosure shows a wearable electronic stimulating device 20 comprising: a distal portion 110 comprising one or more distal electrode modules 22,23, a proximal portion 120 comprising or being remotely connected to one or more of: a control module 130, and a power source 150 for powering the control module 130 and the distal electrode modules 22,23, the distal portion 110 having a cylindrical tapering towards the distal end resilient C-shape configured to fit inside the cymba concha of an ear 100 when the wearable electronic stimulating device 20 is in use, for providing contact towards the inside curve of the antihelix and the cymba concha of the ear, and each distal electrode module 22,23 having an outer curved surface adapted to, and arranged in, the outside surface of the distal portion 110 at a position for being brought in contact with the cymba concha of an ear when the wearable electronic stimulating device 20 is in use. It is also within the inventive concept of the first aspect to arrange any of the control module 130 and the power source 150, and any other components which are not physically required to be arranged in the wearable electronic stimulating device 20, in a standalone remote device 31, 32 being connected to the wearable electronic stimulating device 20 via an electrical interface contact 28. The electrical interface contact 28 may optionally be arranged on a mounted protruding extender 28’ to ensure easy access when in use.

[0155] The electronic stimulating device 20 according to present disclosure provides a data driven non-invasive transcutaneous vagus nerve stimulation. The electrical pulse generating module may be controlled and driven by electronic circuits and/or firmware residing in the electrode control module 130 and/or optional remote devices 31, 32, such as a program residing in a smartphone 31, APP, or a remote computer 32, communicating with the electrode control module. The programs may use different impulses distributed through the electrode modules 21, 22, 23, the electrode modules being electrically connected 50 to the electrode control module 130, for relief of pain and/or stress, for better sleep, for less anxiety, or for athletic recovery etc. These impulse patterns may be regulated through individual unique pain relief programs in the smartphone 31 controlled app, a remote computer 32 or the electrode control module itself.

[0157] The wearable electronic stimulating device 20 according to present disclosure provided as an in-ear-piece, advantageously formed to fit into the cymba conchae of an ear, but other forms may also be adapted. In one embodiment it is provided an electronic stimulating device 20 according to present disclosure using innovative carbon infused silicone which is able to drastically improve ear-fit and stimulation surfaces. In some embodiments the battery and all electronics, such as printed circuit board, components, battery, and wiring are contained in the wearable earpiece. In other embodiments; some of the components, such as battery and/or electrode control module may be comprised in a separate housing, for being carried separately from the ear piece(s) as illustrated in fig.6, and being electrically connected through a signal/power cable 6. The separate housing may for example be carried on the neck.

[0159] The electronic stimulating device 20 according to present disclosure is a t-VNS apparatus able to individually stimulate multiple auricular areas of the vagus nerve with precision, comfort, and high amplitude. Accuracy, strength, and comfort has been detected are all necessary conditions for alleviating chronic pain.

[0161] It was postulated that pain relief from the auricular branch of the vagus nerve can be achieved and amplified through using multiple sites of the ear. It was also postulated that these different sites have unique independent potential to create pain relief. It aligns with cadaver studies showing that the distribution, function, and thickness of myelinated axons along the auricular branch of the vagus nerve, differs greatly between individuals. An effective t-VNS apparatus was invented to target several points of the auricular branch of the vagus nerve, and do so directly, not as an artifact of impudence. Precision stimulation creates more action potentials because it can deliver a higher amplitude in the desired area. This was detected to be crucial, enabling activating a certain number of α-fibers is necessary for t-VNS to be effective, and these myelinated axons need high amplitude to be triggered.

[0163] The electrode control module may individually control the transmitted electrical pulses to the one or more electrode modules 21, 22, 23. Thus, when arranging the electrode modules 21, 22, 23 adjacent key positions, and thus targeting several points of the auricular branch of the vagus nerve 10, directly, substantially better efficiency for pain relief is achieved, and with better comfort and amplitude.

[0165] The electrode control module controls and modify the transmitted electrical pulses in one or more of:

[0166] − duration,

[0167] − wavelength,

[0168] − pulse width,

[0169] − amplitude,

[0170] - frequency, and

[0171] - pattern.

[0173] As illustrated in figure 7 it is shown several possible variation parameters for controlling the pattern of the electrical pulses used in the electronic stimulating device 20. The signal itself, but also to where the signals are sent, which of the electrode modules 21, 22, 23 and dependent on where the individual electrode modules 21, 22, 23 are located.

[0175] Table 1, below, illustrates various electrical pulse schemes that is enabled with the electronic stimulating device 20 according to present disclosure, wherein the area targeted with individual electrode modules 21, 22, 23 are arranged according to the sectioning of a human ear showing different regions according to historical ear acupuncture as shown in figure 2 A.

[0180] Table 1: Examples of various electrical pulse schemes

[0182] According to the present disclosure the number of electrode modules 21, 22, 23 are two or more.

[0184] The electronic stimulating device 20 may be adaptable to be arranged at the ear concha and tragus and/or the antihelical fold and conchal bowl of an ear. Since two or more electrode modules 21, 22, 23 are advantageously comprised in the electronic stimulating device 20 of the electronic stimulating device 20, there has been provided a wearable devise designed to cover multiple areas that is to be targeted, for example as highlighted in table 1 above. Figure 3B and 6 illustrate the wearable devise, showing individual arrangement of the endpoints of the electrode modules 21, 22, 23. It can be seen that the electrode modules 21, 22, 23 corresponds to being arranged adjacent respective sub-branches 11,12,13,14 of the auricular branch of the vagus nerve 10. It is further postulated that, since the nerves present in the ear also comprise several further major nerves, the electronic stimulating device 20 may advantageously also be used to stimulate one or more of these, and that this will have positive effect on the pain relief effect.

[0186] In a first embodiment according to present disclosure the electronic stimulating device 20 the proximal portion 120 comprises one or more proximal electrode modules 21, the proximal electrode module 21 being controlled by the control module 130, and the one or more proximal electrode modules 21 having an outer curved 125 surface substantially adapted to, and arranged in, the outside surface of the proximal portion 120 at a position for being brought in contact with the cavum concha of an ear when the wearable electronic stimulating device 20 is in use. The curvature may deviate from the curvature of the proximal portion 120. Deviation may arise from changed size of the electronic stimulating device 20 and the need to standardize on one or a few size electrode modules. The curvature need not be circular but may in one embodiment be a central flatter portion and a rounded design in the edge area of the electrode module 21.

[0188] Further, the cylindrical tapering form of the C-shaped distal portion 110 is formed with an outside curved form intended for maximizing the contact with the cymba concha of a user’s ear.

[0190] Any of the electrode modules 22,23,21 are electrically paired with another of the electrode modules 22,23,21, and the control module 130 is configured to output a controlled voltage and/or current signal over the one or more paired electrode modules 22,23,21.

[0191] Normally only 2 electrode modules 21, 22, 23 which are paired, are active at the same time. An output pattern and pairing matrix may be dynamically changed in the time domain within the same output sequence. For example for a period of 1 second driving current between the two electrode modules 22, 23 on the distal portion, and the next 2 seconds driving a current between the inner electrode module on the distal portion and the electrode module 21 on the proximal portion, so on. The output signal is configured to output a constant current value as defined. In practice the impedance may vary, at least between users, and the voltage is thereby dynamically altered to achieve a constant or desired current flow between the paired electrode modules. When impedance changes during an output session, due to mechanical pressure on the electronic stimulating device 20, or changed humidity, temperature or the like, the voltage is then altered to maintain current output via the electrode modules.

[0193] The control module 130 is configured to control the pairing configuration of the electrode modules 22,23,21. The pairing configuration may be preconfigured, remotely or locally controlled, or dynamically adjusted as a response to input sensed a sensor 27, 30, 140.

[0195] The control module 130 may be configured to output a predefined current over the electrodes 22,23,21 at a predefined pattern and polarity over a predefined pairing scheme of the electrodes 22,23,21.

[0197] For monitoring user reaction and status it may be advantageous to provide a heart rate sensor 140 in the electronic stimulating device 20. The heart rate sensor 140 may be a Photoplethysmography, PPG, sensor, where in one embodiment the sensor is arranged behind a sensor window 141 arranged in the proximal portion of the electronic stimulating device 20. Other types of sensors are possible, with or without a protective glass/window 141.

[0199] The heart rate sensor 140 may typically be able to monitor heart rate, heart rate variability (HRV) beat composition, blood pressure and other.

[0201] For improved current output efficiency one or more of the electrode modules 22,23,21 outer surface the electronic stimulating device 20 comprises an array of multiple spikes 29. The spikes may be designed with a height h between 0,1 and 0,9 mm, and more advantageous between 0,2 and 0,6 mm, and most advantageous between 0,3 and 0,5 mm. The size and number are adaptable to meet the requirement of the use case. It is proposed that for use cases wherein the ear of a user is large, typically in large live stock or other animal cases the sizes and number of spikes in the electrode module is increased. Likewise, it may be reduced for smaller sized users.

[0202] The following numbers and sizes are typically adapted to the form and size of a human ear. But, even in these cases it may be envisaged to alter the size recommendations.

[0204] The spikes may be arranged with at least 0,2 mm distance between w spikes, or more advantageous with at least 0,4 mm distance between spikes, or most advantageous more than 0,6 mm distance between spikes.

[0206] The spikes 29 may have a conical, tapering towards the top, form, wherein the cone top of the spikes is configured to be able to bend into or penetrate the epidermal stratum corneum or the outer, protective layer of the skin of a user’s ear.

[0208] The number of spikes 29 in any of the distal electrodes 22,23 are advantageously more than 20, or more advantageous more than 30, or most advantageous more than 40.

[0210] The number of spikes in any of the proximal electrodes 21 are advantageously more than 40, or more advantageous more than 60, or most advantageous more than 80.

[0212] The actual form, size and number of the spikes adopted in any embodiment according to present disclosure may vary and deviate from the numbers mentioned and the figures without deviating from the inventive concept. The surface of the skin is composed of a hard layer of non-conducting dead cells. It has been seen that a better transmission of electrical pulses between the electrode pins 21, 22, 23 and the area, wherein the various areas of the auricular branch of the vagus nerve 10 that is targeted is located, is achieved if the contact points is provided with spikes that may achieve a better electrical contact with the ear.

[0214] The electronic stimulating device 20 may comprise one or more sensors 27, 30, 140, being any one or more of: temperature sensor, magnetic and/or electric field sensor, humidity sensor, pressure sensor, accelerometer and gyroscope sensor, electrodermal activity and heart rate sensor.

[0216] One or more sensors for detecting a physiological signal responsive to a transcutaneous vagus nerve stimulation is provided, and the electrode control module and the one or more sensors 27, 30, 140, 146 being in communication via wired 28 or wireless communication channel 40 for transmitting sensor data from the one or more sensors 27, 30, 140, 146 to the electrode control module.

[0217] The one or more sensors 27, 30, 140, 146 may for example be arranged in the proximal portion 120 or the extension protrusion 2 of the electronic stimulating device 20. In another embodiment the sensor may be provided by an, optionally further, standalone senor device 30, such as for example a Fingertip Pulse Oximeter, a wearable measuring health metrics like SpO<2>, skin temperature, heartbeat, or the like, as indicated in figure 5.

[0219] The electronic stimulating device 20 according to present disclosure may stimulate reduction of the production of adrenaline, and increasing the level of cortisol and hormones that naturally regulate stress, blood pressure and inflammation. Both adrenaline level, cortisol level, and activity in the Vagus nerve itself, are key influences in chronic pain.

[0221] The reduction in Heart Rate Variability, HRV, can be seen as a marker of health and main body functions, and this may increase stress resilience, optimize recovery, and make a person feel better and be more productive.

[0223] One or more sensors 27, 30, 140, 146 such as a heart rate monitor or an in-ear heart rate monitor may be provided for sensing how a person react to the stimulus from the electronic stimulating device 20. Other sensor data may be collected by the one or more other sensor types. The sensor data constitutes user data that may be used for optimizing the use of the electronic stimulating device and/or communicated via a user interface. The sensor data may further be used to generate and maintain Big Data Models, which again may be used for controlling the executing parameters of the electronic stimulating device 20. In one embodiment it is foreseen that the Big Data Models are used to train an artificial intelligence, AI, module for autonomous adjustment of the controlling parameters of the electronic stimulating device 20. Such AI controlling modules may be implemented in the electrode control module, or the remote processing device such as a smart phone 31 app or a cloud based server 32.

[0225] The one or more sensors 27, 30, 140, 146 may be one or more of, but not limited to:

[0227] - a pulse-oximeter,

[0228] - a sensor for electrodermal changes, and

[0229] - a sensor for electrical impedance.

[0230] Thus, the sensor data is not limited to HRV reaction data, but may be data retrieved from sensors measuring any measurable reaction from a person, such as, but not limited to: sweat, eye pupil change, muscle activity or other. The sensors may be a combination of different sensor types.

[0232] The control module 130 may further be configured to use input from the sensors 27, 30, 140 to set the output voltage level over the electrode module 22,23,21 pairs.

[0234] In the first embodiment, as illustrated in figure 3D and 3E, it is provided for that the distal portion 110 of the electronic stimulating device 20 is a replaceable portion comprising a distal connector device 113,113’ and electrical connectors 114 for quick lock/release from the proximal portion 120, and the proximal portion 120 comprises a corresponding proximal connector device 123,123’ and electrical connectors 124 for cooperating with the distal connector device 113,113’ and electrical connectors 114.

[0236] The electrode modules 22, 23 are connected via connector plugs 114 ‘’ and electrical wiring 114’ to corresponding electrical connector 114, and when the distal portion 110 is connected with the proximal portion 120 the electrode modules 22, 23 is further electrically connected via the electrical connector 124 in the proximal portion to the controller 130.

[0238] In figure 3A it can be seen the contact boundary 111, 121 of the proximal and distal portion. Figure 3D and 3E further show an optional additional alignment feature wherein a protruding member 161 in the proximal portion 120 is provided for being inserted in the receiving recess 160 in the distal portion 110.

[0240] In one alternative embodiment the electrical connectors 114,124 also comprises inbuilt both the connector features of the distal and proximal connector device 113,113’,123,123’.

[0242] The connector devices 113,113’,123,123’ may further comprise one or more of: a magnet 113’, 123’, a spring-loaded snaplock, a bayonet type connector, a threaded type connector, male/female alignment pin 113, 123, and Registered jack, RJ for enhancing the connecting and holding ability of the connector device 113,113’,123,123’.

[0243] It is also within the inventive concept to provide the wearable electronic stimulating device 20 with the proximal and distal portion integrated in one portion without the feature enabling quick separation of the portions.

[0245] Ass seen in figure 3I and 3J wherein the exploded view of the main components of respectively the distal and proximal portion 110,120 is shown.

[0247] A proximal connector module 176 comprising: a magnet recess 123’’ for receiving the magnet 123’, two female alignment pin recess 123, and two electrical connector pin recess 124’ for receiving the two electrical connector pins 124. The electrical connector pin 124 is typically comprising some form of spring-loaded feature ensuring that there is always a certain contact pressure to a receiving contact point in the distal connector module’s electrical connector 114 contact surface.

[0249] A distal connector module 175 comprising: a magnet recess 113’’ for receiving the magnet 113’, two male alignment pins 113, and two electrical connector contact surface device recess 114’ for receiving the two electrical connector 114 contact surface devices.

[0251] When the distal and proximal portions 110,120 as shown in figure 3E and 3D are assembled and connected to each other as shown in figure 3A, the male/female alignment pin and recess 113, 123 ensure correct alignment of the two parts, and the magnets 113’, 123’ maintain the connection once connected together. The electrical connectors 114,124 make contact due to the spring-loaded feature of the electrical connector pins 124.

[0253] In order to enhance the features of the electronic stimulating device 20 the proximal portion further comprises a speaker device 25 arranged for outputting sound, the speaker device 25 being electrically connected to and controlled by the control module 130. The speaker resides behind a membrane assembly 25’ configured to pass on sound waves to the inner ear of a user. The speaker device 25 is arranged on a proximal print card chassis 199 arranged in the inner space of the proximal portion 120.

[0255] The electronic stimulating device 20 may comprise a communication device for enabling communication between the electrode control module 130 and a remote control module 200.

[0256] The communication device may further provide communication between two control modules 130 arranged to be used by a same user. Thus the signal pattern may be controlled in the two devices for optimal effect.

[0258] The electrodes modules 22,23,21 and the distal and proximal portion 110,120 may advantageously provide waterproof enclosures, wherein the electronic components inside 145,145’ the distal and proximal portions 110,120 are connected in a dry environment. In one embodiment the electrodes 21, 22, 23 are mounted in a conduits 21’, 22’, 23’ provided in the distal/proximal portion wall such that a base 171 (not shown for the distal portion 110) inside the distal/proximal portion provides supporting base for a spring-loaded electrode holding module 170 to press the electrode module towards an electrode seat-recess 222, 223 in the distal/proximal portion wall in order to maintain a good water proof sealing boundary.

[0260] The production and assembly of the parts of the proximal and distal portion 120, 110 can be done in multiple ways. One alternative is to produce the house portions in two half each 120’, 120’’, 110’, 110’’, then a first half of each portion may have protruding elements 200 being paired with corresponding recesses (not shown) in the second half and then being pressed together after assembly and mounting of the components in the portion.

[0262] Figure 3H shows the components arranged in a first haft of the distal portion, together with some of the components that are to be arranged in the proximal portion. The figure does not show any of the proximal portion house halves.

[0264] Each of the proximal and distal portion may be coated with a durable and resilient layer of silicon or the like on portions exposed to the environment and which does not cover the sensors or electrode modules.

[0266] The housing of the proximal and distal portion may advantageously be produced by a material having a certain resilience, such that when fitting it to an individual ear it forms and provides a spring-loaded effect to hold the device in place . The material may be a flexible material, able to change form by applying pressure, moderate heat, or other.

[0267] In a further embodiment the electronic stimulating device 20 according to present disclosure comprises:

[0269] a remote processing device comprising communication modules for communicating with the electrode control module, the remote processing device further comprising one or more of:

[0271] - an application, app, for communicating one or more of:

[0272] electrode control module operating mode,

[0273] sensor data, and

[0274] operating mode selection,

[0275] - storage 33 for storing data transmitted from the electrode control module, - communication module 41 for communicating data to/from a server/cloud computer 32.

[0277] In one embodiment the remote processing device is a smart phone 31.

[0279] It may be advantageous to provide an app that is executable on a smart phone for the convenience of keeping the cost level down. It is also generally accepted to use a smart phone for applications related to sensors and health improving gadgets. A smart phone provides easy communication features both for communicating between the app and the electronic stimulating device 20 according to present disclosure, and any sensors or modules associated with the electronic stimulating device 20. It is further advantageous to use the communication protocols supported by the smartphone to provide a communication channel between the electronic stimulating device 20 and any remote processing services such as for example provided as a cloud service. The smart phone may be substituted with any other processing device comprising communication features and components associated with executing special purpose programs provided for the operation of the electronic stimulating device 20.

[0281] The electrode control module may further control the electrical pulses transmitted to each individual electrode module 21, 22, 23 based on feedback from the one or more sensors 27, 30, 140. It is thus possible to monitor HRV reactions to any changes made to the characteristics of the electrical pulses. One of the drawbacks of any of the prior art techniques is that any current above the 1-2 mA region is becoming extremely uncomfortable or painful for a person using one of those supported devices. Using the electronic stimulating device 20 according to present disclosure is possible to stimulate multiple areas, for example two or more locations of the auricular branch of vagus in sequence using for example a 0-500 ms pulse width of 8-30 Hz and current strength in the region of 0-8 mA, or higher. This is used as an example only, but the embodiments shall comprise a sequence comprising any pair combination of any of the electrode modules 21, 22, 23, and also a sequence not depending on the order of appearance. Also for some sequence schemes may exclude the use of one or more of the available electrode modules. Alternative embodiments of the device of present disclosure may comprise more electrode modules than illustrated in the figures. Being able to alter the stimulation changing between several stimulation areas in sequence may enable a higher electrical power/current to be distributed less side effects/discomfort.

[0283] In a further embodiment of the electronic stimulating device 20 according to present disclosure each electrode module may individually stimulate any of several auricular branches of the vagus nerve, and several auricular branches of the vagus nerve may simultaneously be stimulated. Although many of the embodiments discussed in present disclosure mentions the auricular vagus nerve, it should be understood that any of the major nerve types being present in an ear may be stimulated in the same manner, in combination with stimulation of the auricular vagus nerve, or separate. This includes, but is not limited to: the auriculotemporal nerve 15, the great auricular nerve 16, and/or other cranial nerves.

[0285] In a further advantageous embodiment of the electronic stimulating device 20 according to present disclosure the number of electrode modules are 3 or more. It is thus possible to stimulate at least 3 individual and separate branches of the auricular vagus nerve in sequence as discussed above.

[0287] It has been proven that a precise, intelligent, multisite stimulator may increase efficiency. The electronic stimulating device 20 according to present disclosure may stimulate three or more densely myelinated sites along the auricular branch of the vagus nerve, ABVN, and have the capability to do so independent of one another. As the necessary density of axons for vagal activation has huge intra-individual variability, the electronic stimulating device 20 according to present disclosure may stimulate different sites while tracking changes in HRV in real-time, optimizing vagal activity. The HRV data will form the basis for provided machine learning software, which may create clinical stimulation parameters for use in the electronic stimulating device 20 according to present disclosure.

[0289] In a second embodiment of the electronic stimulating device 20 according to present disclosure, as shown in figure 4A-D, the electronic stimulating device 20 comprises one or more heat emitting areas 34.

[0291] The electrode control module 4 may further comprising an extension protrusion 2 for being inserted into an air canal.

[0293] The electronic stimulating device 20 may be adaptable to be arranged at the ear concha and tragus and/or the antihelical fold and conchal bowl of an ear, as seen in figure 6. Since two or more electrode pins 21’, 22’, 23’, 24, 26 are advantageously comprised in the electronic stimulating device 20 of the electronic stimulating device 20, there has been provided a wearable devise designed to cover multiple areas that is to be targeted, for example as highlighted in table 1 above. Figure 4A – 4D, and 6 illustrate the wearable devise, showing individual arrangement of the endpoints of the electrode pins 21’, 22’, 23’, 24, 26. It can be seen that the electrode pins 21’, 22’, 23’, 24, 26 corresponds to being arranged adjacent respective sub-branches 11,12,13,14 of the auricular branch of the vagus nerve 10. It is further postulated that, since the nerves present in the ear also comprise several further major nerves, the electronic stimulating device 20 may advantageously also be used to stimulate one or more of these, and that this will have positive effect on the pain relief effect.

[0295] In one embodiment according to present disclosure the electronic stimulating device 20 the electrode control module 4 may further comprising an earhook 3 as seen in figure 4A-4D for being arranged over and around the base of an ear. Thereby a much better, safer and stable arrangement of the electrode pins 21’, 22’, 23’, 24, 26 may be achieved.

[0297] In yet another embodiment, one more of the electrode pins 21’, 22’, 23’, 24, 26 may be arranged in the earhook 3. Thus, electric stimulation may be distributed towards nerves from the backside of the auricle of the ear.

[0299] One or more of the electrode pins 21’, 22’, 23’, 24 comprised in the base entity 1, 1’ is advantageously designed with a base portion and a protruding portion as exemplified in figure 5A, such that the protruding portion is designed to exactly target an area of a contacting ear corresponding to a specific underlying nerve junction, such as a specific branch of the ABVN or other nerve. The pin width p<w >of the upper portion of the electrode pins 21’, 22’, 23’, 24, 26 may be narrow, as small as less than 5 mm, and even more advantageously less than or equal to 2 mm.

[0301] The one or more of the electrode pins 21’, 22’, 23’, 24, 26 arranged in the earhook 3 may be designed with a broader contact surface, for example about 5-10 mm<2>.

[0303] The material used in the base entity 1, 1’ and/or the earhook 3 of the electronic stimulating device 20 may advantageously be produced by a material being flexible and formable, such that when fitting it to an individual ear it takes on and holds a form until actively being changed to another form. The material may be a flexible material, able to change form by applying pressure, heat, or other.

[0305] The electronic stimulating device 20 according to the second embodiment comprising an in-ear piece 1, 4 and advantageously comprising a further holding element 3 for reaching around and to the backside of the ear, the further holding element 3 alternatively comprising electrode pins 21’, 22’, 23’, 24, 26 for arrangement near the Antihelix of an ear.

[0307] A heat emitting area 34 is shown as an integrated portion of the electronic stimulating device 20 according to the second embodiment, preferably into the extension protrusion 2 for being inserted into an air canal, as seen in figure 4A, 4B and 4C. This is for illustration purpose only, and it should be understood that the heat emitting area(s) 34 may also be comprised in any other area of the electronic stimulating device 20 according to the second embodiment. Typically the heat emitting area will be constructed as a heat emitting electric wire coupled to the power source, and controlled by for example the electrode control module. Any other form and construction of a controllable heat emitting area/device may be comprised, such as a standalone heat emitting device (not shown) being controlled by the electrode control module or other remote device such as a smart phone app. The actual form, size, construction, and number of the heat emitting areas adopted in any embodiment according to present disclosure may vary and deviate from the figure without deviating from the inventive concept.

[0308] The heat emitting areas 34 may be controlled according to a predefined heat scheme and/or feedback from the sensors 27, 30.

[0310] Using the heat in combination with electrical stimulation via the electrode pins 21’, 22’, 23’, 24, 26 is postulated having a soothing effect, and thus larger currents maybe used in the electrode pins 21’, 22’, 23’, 24, 26 without increasing the discomfort of use to the user. The heat is further believed to prevent or at least reduce discomfort and improve responsiveness of the stimulation. For example if the user is a comatose person, the heating feature may be used to ensure the user is react with less discomfort and thus may be more responsive to the electrical signals distributed by the electrode pins 21’, 22’, 23’, 24, 26.

[0312] The electronic stimulating device 20 according to the second embodiment may stimulate each one of one or more of the electrode pins 21’, 22’, 23’, 24, 26 with a current strength up to 10 mA, and may use the built-in resistance in the extension protrusion 2 or the electronic stimulating device 20 to create heat emitting areas 34. The heat is applied to the receiving areas close to the electrode pins 21’, 22’, 23’, 24, 26 for concealing an unpleasant sensations related to the high amplitude stimulation and make the stimulation more pleasant and feasible.

[0314] In a related use scenario the electronic stimulating device 20 according to the second embodiment may be used in clinical trials, wherein the heat emitting areas 34 can function as a sham stimulation, solving a problem for scientific communities, wherein it may be difficult to camouflage a scam device in operation. Thus the electronic stimulating device 20 according to the second embodiment may be used as a scam device only delivering heat and not electronic stimulating pulses, to fulfill the requirement of test scenarios wherein a certain percentage of test personnel shall be objects to scam process to verify the efficiency of the correctly operating devices and methods.

[0316] It should be understood that the features and characteristics of the various embodiments presented in present disclosure can be adapted for use in combination with any of the other embodiments described. For example the heat emitting area 34 of the second embodiment may be implemented and used for similar purpose in the first embodiment, and the audio output of the first embodiment may be used for similar purpose in the second embodiment. It should further be understood that features of the electrode modules 21, 22, 23’, 24, 25, 26 of the second embodiment and vice versa. The same goes for the holding element 3 of the second embodiment and the distal portion 110 of the first embodiment. These examples do not exclude that other parts and features are used across the embodiments described.

[0318] The second aspect of this disclosure shows a method for operating a wearable electronic stimulating device 20, comprising the steps: providing one or more wearable electronic stimulating devices 20 according to the first aspect, arranging the one or two electronic stimulating device 20 according to present disclosure in the cymba concha and calum concha of a user’s ear, where one or more electrode modules 21, 22, 23 of the electronic stimulating device 20 can stimulate several auricular branches of the vagus nerve in the ear, and further providing a current output pattern for the control module 130, arranging for the wearable electronic stimulating device 20 to output a voltage/current according to a provided output pattern.

[0320] The method may further comprise the following steps:

[0322] arranging one or more sensors 27, 30, 140, 146 for detecting a physiological signal responsive to a transcutaneous vagus nerve stimulation, and

[0324] adjusting the duration, wavelength, pulse width, amplitude and frequency of the electrical pulse to the one or more electrode modules 21, 22, 23 in accordance with the detected physiological signal responsive to the transcutaneous vagus nerve stimulation.

[0326] The method may further comprise to, when the number of electrode modules 21, 22, 23 are paired:

[0328] transmitting electrical pulses to the paired electrode modules 21, 22, 23 in accordance with a configurable transmitting sequence.

[0330] Although figure 3A-3J shows two electrode modules in the distal portion it should be understood that the number of electrode modules may be more than two such that more areas in the cymba concha can be targeted. The same is true for the number of electrode modules in the proximal portion which may be more than one such that more areas in the calum concha can be targeted.

[0332] In one embodiment of the invention only two of the electrode modules may be paired for outputting a signal at a time. This means that only one pair of electrode modules are active at any point in time. During a time sequence of using the wearable electronic stimulating device pairing may change to optimize output and coverage of several target areas.

[0334] The method may further comprise:

[0336] providing one or more heat emitting areas 34, and activate heat radiation from the heat emitting areas.

[0338] The method may further comprise:

[0340] adjusting the heat emitted from the heat emitting areas 34 in response to the detected physiological signals responsive to the transcutaneous vagus nerve stimulation.

[0342] The method may further comprise:

[0344] administrating activities, such as using the audio output 25 in response to the detected physiological signal responsive to the transcutaneous vagus nerve stimulation, the external activities being one or more of:

[0346] playing a tune or sound,

[0348] instructions for meditation, and

[0350] instructions for breathing techniques.

[0352] The third aspect of this disclosure shows a system for operating a wearable electronic stimulating device comprising: one or more wearable electronic stimulating device according to any of the first aspect, and a remote control module for controlling the one or more wearable electronic stimulating device 20.

[0353] It may further be provided one or more communication networks 40, 41 for providing communication channels between the electronic stimulating devices 20 and the remote processing device 31, 32.

[0355] It may be advantageously to use wearable electronic stimulating device 20 in a setup where two wearable electronic stimulating device 20 is provided and mounted to each of the left and right ear of a user respectively. The stimulating pattern and order may then alter between all the electrode modules of both electronic stimulating devices 20.

[0357] The person skilled in the art realizes that the present disclosure is not limited to the preferred embodiments described above. The person skilled in the art further realizes that modifications and variations are possible within the scope of the appended claims.

[0359] Additionally, variations to the disclosed embodiments can be understood and effected by the skilled person in practicing the claimed disclosure, from a study of the drawings, the disclosure, and the appended claims.

Claims (25)

1. A wearable electronic stimulating device (20) comprising:

a distal portion (110) comprising one or more distal electrode modules (22, 23),

a proximal portion (120) comprising of or being remotely connected to one or more of: a control module (130) and a power source (150) for powering the control module (130) and the distal electrode modules (22, 23),

the distal portion (110) having a cylindrical tapering towards the distal end resilient C-shape configured to fit inside the cymba concha of an ear (100) when the wearable electronic stimulating device (20) is in use, for providing contact towards the inside curve of the antihelix and the cymba concha of the ear, and

each distal electrode module (22, 23) having an outer curved surface adapted to, and arranged in, the outside surface of the distal portion (110) at a position for being brought in contact with the cymba concha of an ear when the wearable electronic stimulating device (20) is in use.

2. The wearable electronic stimulating device (20) according to claim 1, wherein:

the proximal portion (120) comprising one or more proximal electrode modules (21), the proximal electrode module (21) being controlled by the control module (130), and the one or more proximal electrode modules (21) having an outer curved surface adapted to, and arranged in, the outside surface of the proximal portion (120) at a position for being brought in contact with the cavum concha of an ear when the wearable electronic stimulating device (20) is in use.

3. The wearable electronic stimulating device (20) according to any one of the previous claims, wherein:

the cylindrical tapering of the distal portion (110) is formed with an outside curved form intended for maximizing the contact with the cymba concha of a user’s ear.

4. The wearable electronic stimulating device (20) according to any one of the previous claims, wherein:

any of the electrode modules (22, 23, 21) are electrically paired with another of the electrode modules (22, 23, 21), and

the control module (130) is configured to output a controlled voltage and/or controlled current over the one or more paired electrode modules (22, 23, 21).

5. The wearable electronic stimulating device (20) according to claim 4, wherein:

the control module (130) is configured to control the pairing configuration of the electrode modules (22, 23, 21).

6. The wearable electronic stimulating device (20) according to claim 5, wherein: the control module (130) is configured to output a predefined current over the electrodes (22, 23, 21) at a predefined pattern and polarity over a predefined pairing scheme of the electrodes (22, 23, 21).

7. The wearable electronic stimulating device (20) according to any one of the previous claims, further comprising:

a heart rate sensor (140).

8. The wearable electronic stimulating device (20) according to claim 7, wherein the heart rate sensor (140) is a Photoplethysmography, PPG, sensor, and the sensor is arranged behind a sensor window (141) arranged in the proximal portion of the wearable electronic stimulating device (20).

9. The wearable electronic stimulating device (20) according to any one of the previous claims, wherein:

one or more of the electrode modules (22, 23, 21) outer surface comprising an array of multiple spikes (29).

10. The wearable electronic stimulating device (20) according to claim 9, wherein the spikes have a height (h) between 0,1 and 0,9 mm, and more advantageous between 0,2 and 0,6 mm, and most advantageous between 0,3 and 0,5 mm.

11. The wearable electronic stimulating device (20) according to claim 9 or 10, wherein the spikes are arranged with at least 0,2 mm distance between (w) spikes, (29) or more advantageous with at least 0,4 mm distance between spikes (29), or most advantageous more than 0,6 mm distance between individual spikes.

12. The wearable electronic stimulating device (20) according to any one of claim 9 to 11, wherein the spikes (29) have a conical, tapering towards the top, form, and the cone top of the spikes are configured to be able to bend into or penetrate the epidermal stratum corneum or the outer, protective layer of the skin of a user’s ear.

13. The wearable electronic stimulating device (20) according to any one of claim 9 to 12, wherein the number of spikes (29) in any of the distal electrodes (22, 23) are more than 20, or more advantageous more than 30,or most advantageous more than 40.

14. The wearable electronic stimulating device (20) according to any one of claims 9 to 12, wherein the number of spikes (29) in any of the proximal electrodes (21) are more than 40, or more advantageous more than 60,or most advantageous more than 80.

15. The wearable electronic stimulating device (20) according to claim 1,

further comprising:

one or more sensors (27, 30, 140, 146), being any of: temperature sensor, magnetic and/or electric field sensor, humidity sensor, pressure sensor, accelerometer and gyroscope sensor, electrodermal activity and heart rate sensor.

16. The wearable electronic stimulating device (20) according to claim 15, wherein:

the control module (130) is further configured to use input from the sensors (27, 30, 140, 146) to configure the output voltage level over the electrode module (22, 23, 21) pairs.

17. The wearable electronic stimulating device (20) according to any one of the previous claims, wherein:

the distal portion (110) is a replaceable portion comprising a distal connector device (113, 113’) and electrical connectors (114) for quick lock/release from the proximal portion (120), wherein the proximal portion (120) comprising a corresponding proximal connector device (123, 123’) and electrical connectors (124) for cooperating with the distal connector device (113, 113’) and electrical connectors (114).

18. The wearable electronic stimulating device (20) according to claim 17, wherein:

the electrical connectors (114, 124) comprise the distal and proximal connector device (113, 113’, 123, 123’).

19. The wearable electronic stimulating device (20) according to claim 17 or 18, wherein: the connector devices (113, 113’, 123, 123’) comprise one or more of: a magnet, a spring loaded snaplock, a bayonet type connector, a threaded type connector, male/female alignment pin, and Registered jack, RJ.

20. The wearable electronic stimulating device (20) according to any one of the previous claims, wherein:

the proximal portion further comprising a speaker device (25) arranged for outputting sound, the speaker device (25) being electrically connected to and controlled by the control module (130).

21. The wearable electronic stimulating device (20) according to any one of the previous claims, further comprising a communication device for enabling communication between the electrode control module (130) and a remote control module (200).

22. The wearable electronic stimulating device (20) according to any one of the previous claims, wherein:

the electrodes modules (22, 23, 21) and the distal and proximal portion (110, 120) provides waterproof enclosures, wherein the electronic components inside (145, 145’) the distal and proximal portions (110, 120) are connected in a dry environment.

23. A method for operating a wearable electronic stimulating device, comprising the steps: providing a wearable electronic stimulating device (20) according to any of claim 1 to 22, providing a current output pattern for the control module (130), and

arranging the wearable electronic stimulating device (20) for outputting a voltage/current according to a provided output pattern.

24. A system for operating a wearable electronic stimulating device comprising:

one or more wearable electronic stimulating device (20) according to any of claim 1 to 22, and a remote-control module for controlling the one or more wearable electronic stimulating device (20).

25. The system according to claim 24, wherein the voltage/current pattern of a pair of wearable electronic devices (20) is adapted and controlled according to a unique personal profile of a user communicated from the remote-control module.