Portable and wearable system for neuro modulation to control pain in trigeminal neuralgia

Abstract

A portable and wearable system (100) for neuro modulation to control neuropathic pain particularly controlling pain in trigeminal neuralgia, wherein the system (100) comprises a head or neck or ear wearable device (102) having multiple detachable and adjustable miniature vibrators (114) that are connected with a respective elongated bendable connector allowing the vibrators to be placed at targeted affected area of the user to provide vibrotactile stimulation to the affected area. The vibrators (114) are controlled through a wireless control module (106) via a remote-control unit (200) allowing the vibrators (114) to be operating at variable frequency, intensity, pulse duration, number of pulses, and time of operation independently in response to signal received from the remote-control unit (200) for automatic and effective pain management at the affected area of the user.

Description

PORTABLE AND WEARABLE SYSTEM FOR NEURO MODULATION TOCONTROL PAIN IN TRIGEMINAL NEURALGIACROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority from Indian Patent Application Number 202431042773, entitled “PORTABLE AND WEARABLE SYSTEM FOR NEURO MODULATION TO CONTROL PAIN IN TRIGEMINAL NEURALGIA”, filed on June 052, 2024, which application is hereby incorporated herein by reference in its entirety.FIELD OF THE INVENTION

[0002] The invention generally relates to the field of non-invasive therapeutic medical devices related to neuropathic pain management, more specifically the present invention relates to a system for managing neuropathic pain due to trigeminal neuralgia.BACKGROUND OF THE INVENTION

[0003] The following background information may present examples of specific aspects of the prior art (e.g., without limitation, approaches, facts, or common wisdom) that, while expected to be helpful to provide additional aspects of the prior art, is not to be construed as limiting the present invention, or any embodiments thereof, to anything stated or implied therein or inferred thereupon.

[0004] Trigeminal neuralgia (TN) is a chronic pain condition that affects the trigeminal nerve, which is responsible for transmitting sensory information from the face to the brain. TN is characterized by sudden, severe, and often debilitating facial pain. The pain episodes are typically brief but can occur in quick succession, severely impacting the quality of life of those affected. Triggers for these pain attacks can include simple activities such as chewing, speaking, or even touching the face.

[0005] The current management of TN includes pharmacological treatments, surgical interventions, and other forms of neuromodulation. Medications, such as anticonvulsants and muscle relaxants, are often the first line of treatment but can havesignificant side effects and may become less effective over time. Surgical options, including microvascular decompression and radiofrequency rhizotomy, offer more permanent solutions but carry risks associated with invasive procedures. Neuromodulatory devices like those providing electrical stimulation to the trigeminal nerve have shown promise but are not without limitations, such as patient discomfort which may result in dysesthesia.

[0006] Numerous attempts have been made and several prior arts are known for variety of devices, systems and methods have been tested in the prior art to manage neuropathic pain in head and neck region. Even though these innovations may be suitable for the specific purposes to which they address, however, they would not be as suitable for the purposes of the present invention.

[0007] For example, US Patent No. US 10974047B2 to Lisa C. Nelson discloses a device for treatment of temporomandibular joint (TMJ) disorder, wherein the device combines the benefits of LED therapy with the stimulation and pain-relieving qualities of a transcutaneous electrical nerve simulation (TENS) unit for the TMJ treatment. The device comprises an adjustable headband strap with a shoulder extension, and face and head extensions and a remote TENS controller. Further, the device comprises acupuncture points for skin rejuvenation.

[0008] For example, Korean Patent App. No. KR2014024161A to Shin Jet Won relates to a facial massage apparatus comprises plurality of supports are arranged radially spaced apart from each other and provided with a nose receiving groove. A vibrator in contact with the plurality of supports of the face support and to generate vibration to transmit the vibration to the user's face. A control unit provided to be electrically connected to the vibration unit to control the vibration generated by the vibration unit.

[0009] For example, German Patent App. No. DE102011016505A1 to Anmelder Gleich relates to a bow-shaped massaging apparatus used in treatment of temporomandibular dysfunction. The apparatus has massage surfaces with work areas having flat or convex patches which exert pressure of preset value with respect to head.

[0010] For example, PCT Pat. App. No. WO2014129690A1 Kim Young Han discloses a device having a headset frame with both ends positioned at the painful region of the temporomandibular joint for generating a high frequency signal for alleviating pain. It further comprises a temperature sensor and a control unit for controlling the high frequency generation part according to the temperature detected by the temperature sensor so as to adjust the intensity of the output high frequency signal while preventing the burn caused by the heat of the high frequency electrode in healing.

[0011] For example, PCT Pat. App. No. W02017197150A1 to Ronald M. Harper discloses a non-electrical stimulation system comprising a vibration source in contact with at least two magnets for non-invasive vibration stimulation procedures for treating, reducing and alleviating symptoms associated with pain, stroke, mood, vascular action, breathing disorders, and sleep induction.

[0012] For example, PCT Pat. App. No. WO2021016246A1 to Chao Hsing Yeh discloses a non-invasive auricular point stimulation device that is controlled by a controller, and includes an earpiece having at least one electrode with a gel pad to electrically stimulate ear acupoints for treating pain for pain at that area.

[0013] For example, Chinese Utility Model CN219480555U to Pierre-Yves Muller discloses a temporomandibular joint disorder treatment device, comprising a headband is fixed on the head of a patient, earmuffs are attached to the ears, a pair of rotatable shell covers the cheeks of the patient, a heater and / or a vibrator attached to the shells provides hot compress or massage around the temporomandibular joint of the patient for alleviating pain and physiotherapy.

[0014] For example, Chinese Utility Model CN213047619U to Zhang Zihan et al. discloses a portable rear- wearing temporomandibular joint hot compress pulse physiotherapy instrument comprising an arc-shaped connecting rod, a hook, a pair of functional modules to provide hot compress and physiotherapy simultaneously.

[0015] For example, Chinese Utility Model CN217793768U to Liu Xiaoli discloses an ear-mounted temporomandibular joint physiotherapy instrumentcomprising a joint cover connected with a hanging sleeve. It includes a vibration module and a heating module so as to provide massage and hot compress functions.

[0016] For example, US Pat. App. No. US20170182309A1 to Leon Akchian et al. discloses a device and a method for trigeminal nerve stimulation that includes two apertures spaced apart between a pair of ophthalmic nerves on a patient's forehead. The device may thus be advantageously used to apply cutaneous electrodes to a patient's forehead for trigeminal nerve stimulation without clinical training.

[0017] For example, US Pat. App. No. US20190046787A1 to William J. TYLER et al. discloses a wearable pulsed transdermal electrical stimulation apparatus targeting cervical nerves on the back of the neck includes a pulsed electrical stimulation neckband and an electrode patch comprising a stimulation generator o generate signals for pulsed electrical stimulation.

[0018] For example, PCT patent Application WO2013165697A1 to Denise Barbut et al. discloses an apparatus and method for neuromodulating a trigeminal nerve to treat a variety of medical conditions comprising a plurality of stimulating electrodes configured to contact a portion of a skin of a patient over any of three divisions of a trigeminal nerve wherein the electrode contact is enhanced by means of a conductive gel to neuromodulate a trigeminal nerve including non-invasively stimulating a trigeminal nerve of a patient; and increasing cerebral blood flow.

[0019] For example, Chinese patent CN206239894U to Pierre-Yves Muller discloses an apparatus for trifacial transcutaneous electrostimulation and antimigraine, headache and fibromyalgia etc. The non-invasive apparatus of the treatment of disease. The equipment is designed as being fixed on the forehead of patient or user.

[0020] For example, US patent App. No. US20080082131A1 to Myriam Ivette Llanos discloses a Facial Nerve Stimulator (FNS) that is worn as a headset by resting one end on the ear lobe and inserting the Oral Electrode casing inside the mouth and an exterior Electrode casing rests just over the mandibular condyle, the FNS system is activated to allow small electric pulses to stimulate the inside (Maxillary) and the outside (mandibular) of the Trigeminal nerve as well as the mandibular condyle.

[0021] For example, German patent application W02024031086A1 to Kirt GILL discloses devices, systems, and methods for treating a medical condition through a coordinated stimulation of two or more target nerves using a head worn apparatus, wherein the apparatus includes a set of frontal electrodes including a superior frontal electrode and an inferior frontal electrode that are configured to overlie or straddle a supraorbital trigeminal nerve branch of the subject; or a set of lateral electrodes including a concha electrode and a tragus electrode, that are configured to overlie or straddle an auricular branch of the vagus nerve of the subject.

[0022] For example, US patent App. No. US20230277411 Al to Ronald M. Harper et al. discloses a device comprising a vibratory motor, and an earpiece, wherein the earpiece is molded substantially to fit within the external ear canal and applying vibrational energy to at least one of the auditory canal, auricle and concha of the ear, thereby stimulating at least one sensory fiber of a cranial nerve, and a spinal nerve to normalize breathing and blood pressure, induce sleep, increase salivation, and improve vertigo, nausea, minimize visual dysfunction and migraine.

[0023] For example, PCT patent App. No. W02012156051A1 to Christoph Beck et al. discloses a stimulating device for stimulating a nerve of the head or neck region of a human being, wherein the stimulating device comprises at least one stimulating element that is configured to be positioned to the head or neck region of a human being to achieve an efficient stimulation of the nerve at that area.

[0024] For example, US patent App. No. US20220152389A1 to Jonathan D. Charlesworth et al. discloses a portable transdermal electrical stimulation (TES) applicator to evoke or enhance a predetermined cognitive effect to stimulate either the trigeminal, facial and / or cervical plexus. These TES applicators may include a pair of electrodes and a TES control module comprising a processor, a timer and a waveform generator, wherein the applicator applies transdermal electrical stimulation between the anode and cathode until the subject's sympathetic nervous system is suppressed.

[0025] For example, US Patent No. US10864371B2 to Jin Shimada et al. discloses a methods and devices comprising a stimulation unit and a plurality of electrodes fortreating migraine headaches by attaching the electrodes at a first location overlying a trigeminal nerve and at a second location overlying a second nerve, and then delivering electrical series of stimulation pulses to the patient, the stimulation pulses having a duration of between about 1 and about 20 microseconds.

[0026] For example, US Patent No. US11420054B2 to David M. Page et al. discloses a system and method modulating targeted neural and non-neural tissue of a nervous system for the treatment of head-and-face pain. Electrical stimulation is delivered transcutaneously to the treatment site that modulates the targeted neural- and non-neural tissue of the nervous structure, inhibiting nervous signaling and the perception of pain.

[0027] For example, US Patent No. US11433235B2 to Raj Kumar Narayan et al. discloses a device for applying non-invasive neurostimulation to the trigeminal nerve both before and after fluid resuscitation of the patient to improve hemodynamic stability, thereby increasing a blood pressure and an oxygen flow to the brain.

[0028] For example, US Patent No. US8702584B2 to Pierre Rigaux et al. discloses a method for inducing relaxation or sleep comprising the steps of placing electrodes in contact with the forehead skin in the supraorbital region; generating an electrical signal with a signal generator and applying said signal to the electrodes so as to produce external non-invasive, neurostimulation of the upper branch of the trigeminal nerve.

[0029] For example, US Patent No. US8702584B2 to Pierre Rigaux et al. discloses a system for the non-invasive acute treatment of a migraine attack of a patient, comprising at least one skin electrode that is configured for placement on the forehead of the patient so as to provide successive biphasic electrical pulses via the at least one skin electrode during a longer period time span.

[0030] Although various embodiments of the invention may have been motivated by various deficiencies with the prior art, which may be discussed or alluded to in one or more places in the specification, the embodiments of the invention do not necessarily address any portable, detachable, adjustable and reconfigurable multiple vibrotactile based remote controlled wearable system for neuro modulation to control neuropathicpain. Thus, there is a need to prepare a novel device, system and method for easily managing neuropathic pain including trigeminal neuralgia pain.SUMMARY OF THE INVENTION

[0031] According to an aspect, the system of the present invention provides a significant advancement in the field of pain management for Trigeminal Neuralgia and other pain management in the head, face and neck region of a user. The system allows combining a compact, ergonomic portable and wearable device with advanced wireless technology and effective vibrotactile therapy. The system further comprises a remotecontrol unit that allows the user to control and adjust vibration by controlling frequency of the miniature vibrators. Further the remote-control unit has one or more control switches and a display unit that acts as an interface to visualize control parameter for efficient and easy utilization of the system of the present invention. The system allows non-invasive and user-friendly solution to a challenging medical condition, where the user can manage and control pain without any assistance and allows the user to use the system at user’s convenience irrespective of place and time thereby significantly improve the quality of life of TN patients, providing them with a practical and effective tool for managing their pain.

[0032] According to another aspect, the system of the present invention is designed to alleviate pain associated with Trigeminal Neuralgia (TN) through targeted vibrotactile therapy using a biosafe modality and easy to use interface. It integrates advanced wireless communication technology and ergonomic design to offer a portable and user-friendly solution for chronic neuropathic pain sufferers due to TN or other neuropathic pain in their head and neck region. The remote-control unit of the system is a smart phone with dedicated mobile application that allows the user to control and adjust vibration by controlling frequency, amplitude and duration of the miniature vibrators while acting as an interface for data analysis and desired data presentation for efficient and easy utilization of the system of the present invention.

[0033] According to one objective of the present invention is to provide a portableand wearable system that allows non-invasive pain relief for individuals suffering from Trigeminal Neuralgia (TN).

[0034] Another objective of the present invention is to provide an effective, drug- free alternative for managing TN pain.

[0035] Another objective of the present invention is to provide a wearable and customizable and targeted vibrotactile therapy to alleviate pain.

[0036] Another objective of the present invention is to provide a portable, easy to carry and ease of use compact, head or neck or ear-worn system that can also be used while working or moving.

[0037] Another objective of the present invention is to provide a system that can be controlled wirelessly using a mobile application or a remote control.

[0038] Another objective of the present invention is to provide a personalised and adjustable system for quick neuropathic pain relief

[0039] These and other objectives, advantages and aspects of the invention will become apparent from the following detailed description, taken in conjunction with the accompanying drawings, which illustrate, by way of example, the features in accordance with embodiments of the invention. The summary is not intended to limit the scope of the invention, which is defined solely by the claims of the present invention.BRIEF DESCRIPTION OF THE DRAWINGS

[0040] The present invention will be better understood with reference to the following description taken in combination with the drawing. Certain embodiments of the present invention are illustrated in the appended drawing. In the drawings, like numerals or alphabets indicate like elements throughout. It is to be noted, however, that the appended drawing illustrates only typical embodiments of this invention and are therefore not to be considered limiting of its scope, for the invention may admit to other equally effective embodiments. In the drawing:

[0041] FIG. 1 shows a wearable device of a system for neuro modulation to controlneuropathic pain in trigeminal neuralgia, according to an embodiment of the invention;

[0042] FIG. 2 shows an exploded view of the wearable device as shown in FIG. 1, according to an embodiment of the invention;

[0043] FIG. 3 discloses a perspective view of two wearable devices of the system for neuro modulation to control neuropathic pain in trigeminal neuralgia, wherein the devices are connected via a neck / head band to be worn on both side of head of the user, according to an embodiment of the invention;

[0044] FIG. 4 shows an exploded view of the two wearable devices of the system for neuro modulation to control neuropathic pain in trigeminal neuralgia as shown in FIG. 3, according to an embodiment of the invention;

[0045] FIG. 5 shows a head / neck band of the system, according to an embodiment of the invention;

[0046] FIG. 6 discloses an exploded view of the head / neck band as shown in FIG.5, according to an embodiment of the invention;

[0047] FIG. 7A illustrates a cross-sectional view of the wearable device as shown in FIG. 1, showing internal configuration of the wearable device and their arrangement inside a casing, according to an embodiment of the invention; and

[0048] FIG. 7B illustrates a smart phone with dedicated mobile application that acts as a remote-control unit of the system for improved control and effective utilization of the system, according to an embodiment of the invention.

[0049] FIG. 8 illustrates a user positioning multiple miniature vibrators of the system around the affected areas of the user, according to an embodiment of the invention.

[0050] Like reference numerals refer to like parts throughout the various views of the drawings.DETAILED DESCRIPTION OF THE INVENTION

[0051] The following detailed description is merely exemplary in nature and is not intended to limit the described embodiments or the application and uses of thedescribed embodiments. As used herein, the word “exemplary” or “illustrative” means “serving as an example, instance, or illustration.” Any implementation described herein as “exemplary” or “illustrative” is not necessarily to be construed as preferred or advantageous over other implementations. The present invention now will be described hereinafter with reference to the accompanying examples and / or drawings, in which embodiments of the invention are shown in FIGs 1-8. This description is not intended to be a detailed catalog of all the different ways in which the invention may be implemented, or all the features that may be added to the instant invention. For example, features illustrated with respect to one embodiment may be incorporated into other embodiments, and features illustrated with respect to a particular embodiment may be deleted from that embodiment. Thus, the invention contemplates that in some embodiments of the invention, any feature or combination of features set forth herein can be excluded or omitted. In addition, numerous variations and additions to the various embodiments suggested herein will be apparent to those skilled in the art in light of the instant disclosure, which do not depart from the scope of the instant invention. Hence, the following descriptions are intended to illustrate some particular embodiments of the invention, and not to exhaustively specify all permutations, combinations and variations thereof.

[0052] According to various embodiments of the present invention as shown in FIGs. 1-8, a portable and wearable system (100) comprising a wearable device (102) and remote-control unit (200) to wirelessly control the functioning of the wearable device (102). The wearable device (102) is designed to be worn on the head, or neck or ear of a user, wherein the device (102) is configured to stimulate targeted nerves for controlling neuropathic pain in trigeminal neuralgia. The system (100) is configured to provide controlled and targeted vibrotactile therapy to relieve pain associated with Trigeminal Neuralgia. According to an exemplary embodiment, the wearable device (102) of the system (100) is provided with a silicone ear hook / loop (104) and ear bud / plug (112) for secure and comfortable positioning of the device (102). The wearable device (102) is provided with a Bluetooth or Wi-Fi enabled wireless controlmodule (106) for controlling the desired vibration at the targeted area using the remotecontrol unit (200).

[0053] According to an aspect of the present invention as shown in FIGs. 1-8, a portable and wearable system (100) for neuro modulation to control neuropathic pain, wherein the system (100) characterized in that comprises: a) at least one wearable device (102) that are provided with a rotatable and detachable ear loop (104) to hold the device (102) at the desired position around ear region of a user (300), wherein the device (102) comprises: i. at least one wireless enabled control module (106) powered by a power supply module (108) enclosed in a casing (110), wherein the casing is provided with an ear plug (112) to wear the device (102) on the ear of the user (300); ii. multiple adjustable miniature vibrators (114) functionally and detachably connected to the control module (106), wherein the vibrators (114) are provided with varying length of elongated bendable connectors (116) acting as connectors, which are configured to position each vibrator (114) at targeted affected area of the user (300); and b) a remote-control unit (200) to wirelessly control functions of the control module (106) to control parameters including frequency, intensity, pulse duration, number of pulses, and time of operation of the multiple miniature vibrators (114) for automatic and effective pain management at the affected area of the user.

[0054] According to another aspect of the present invention, each of the wearable device (102) comprises two clusters (114a-b) of miniature vibrators that are detachably connected with the control module, wherein each cluster (114a, 114b) comprises four miniature vibrators (114).

[0055] According to another aspect of the present invention, the multiple miniature vibrators (114) are capable of operating at variable frequencies ranging from 10 Hz to 100 Hz and amplitude / intensity ranging from 10-45dB for a pulse duration ranging from 100ms to 1000ms.

[0056] According to another aspect of the present invention, the system (100) comprises two wearable devices (102) configured to be mounted on both the ears of the user (300), wherein the two wearable devices (102) are configured to be connectedby a detachable, adjustable and foldable head / neck band (120) to securely hold the device at the desired position around head or neck region of the user.

[0057] According to another aspect of the present invention, the head / neck band (120) comprises two terminal pieces (122a, 122b) with a “C shaped” holder (124a, 124b) at distal end to hold the two wireless devices (102) in position at both the ears of the user, and a central piece (126) of the head / neck band (120) is configured to snap fit the proximal ends of the two terminal pieces (122a, 122b) to provide detachable attachment of the head / neck band for easy and quick foldability and storage.

[0058] According to another aspect of the present invention, the remote-control unit (200) has one or more control switches (202) and a display (204) that acts as an interface to visualize to easily control the parameters including frequency, intensity, pulse duration, number of pulses, and time of operation of the multiple miniature vibrators (114).

[0059] According to another aspect of the present invention, the remote-control unit (200) is a smart phone provided with a smartphone application that is configured to control the device(s) (102) wirelessly to adjust the parameters of the vibrators (114).

[0060] According to another aspect of the present invention, the controller module (106) is a ESP32 controller module.

[0061] According to another aspect of the present invention, the power supply module (108) is a lithium-ion rechargeable battery.

[0062] According to another aspect of the present invention, the device (102) is provided with a charging port (117) and an ON / OFF switch (118).

[0063] According to another aspect of the present invention, the ear plug (112) is made of silicone so as to act as a sound and vibration proof attachment for the user’s ear.

[0064] According to an embodiment, the system (100) of the present invention as shown in FIGs. 7A-B. The system (100) comprises a) at least one wearable device (102) with plurality of miniature vibrators (114) as shown in FIGs. 1-4 FIG. 7 A and FIG. 8 and a remote-control unit as shown in FIG. 7B, wherein the system (100)works with the well-established gate control theory of pain modulation by utilizing vibrotactile stimulation. The system (100) allows to inhibit pain pathways through preferential conduction of vibrotactile stimuli, effectively "closing the gate" to pain signals.

[0065] According to another embodiment as shown in FIGs. 1-4, the wearable device (100) is encased in a casing (110) that is lightweight and made of skin- friendly material, The casing (110) is designed to fit comfortably around the ear of a user. The casing ( 110) is provided with an ear loop or hook ( 104) that ensures secure attachment, allowing the user to wear the device discreetly for long hours as per the need for total pain relief using the system (100) of the present invention. Further the loop (104) is configured to be twisted so that it allows the device (102) to be used on left or right ear as per the need. According to another embodiment of the present invention, the casing (110) of the device (102) is provided with an ear plug (112), wherein the ear plug (112) is made of silicone and it is configured to provide additional stability to the device (102) to be hold on to the ears of the user (300) while acting as a sound proof and comfort attachment for the user (300). comprises multiple According to another embodiment of the present invention, the device (102) comprises multiple miniature vibrators (114) capable of operating at variable frequencies. These vibrators (114) are connected via elongated bendable connectors (116) that are configured to be strategically place the vibrator (114) to deliver desired vibration at the targeted areas, stimulating the trigeminal nerve to provide vibration therapy mechanism to relief pain. According to an exemplary embodiment, eight numbers of the miniature vibrators (114) are used, however without limitation more or less numbers of vibrators (114) can be used without departing from the scope and the spirit of the present invention.

[0066] The location of the vibrators (114) is distributed as per the distribution of the ophthalmic, maxillary and mandibular branches of trigeminal nerve location. The user (300) can place the vibrators (114) around the zone of neuralgia by bending or extending the bendable / flexible connectors (116) to the affected area on one side of the face of the user (300). Further the vibrators (114) are configured to be detachablyconnected to the control module (106) of the wearable device (102) to facilitate ease of use and storage as shown in FIG. 2 and 4.

[0067] According to another embodiment of the present invention as shown in FIG. 7A, the wireless device (102) of the system (100) comprises a control module (106) which offers both Bluetooth and WiFi connectivity with the remote-control unit (200) such as a smart phone to allow wireless control of the device(s) (102) to adjust vibration settings via a smartphone application. According to an exemplary embodiment, without limitation, the controller module (106) is a ESP32 controller module. Further, the smartphone application enables users (300) to customize their therapy experience that allows the system (100) to provide options to adjust the frequency, intensity, and patterns of the vibrations, ensuring personalized pain management, further it allows analysis of the data including time of operation, frequency, intensity, pain time etc. of the user (300) for patient history analysis for better experience.

[0068] According to another embodiment of the present invention as shown in FIG. 7A, the system (100) further comprises a power supply module (108) without limitation a rechargeable lithium-ion battery to provide uninterrupted power supply for extended wireless use and can be easily recharged without limitation using a standard micro- USB interface.

[0069] According to another exemplary embodiment as shown in FIGs. 7A-B, the wearable device of the system of the present invention comprises eight miniature vibrators (114) that can be controlled or adjusted with variable frequency control. The device (102) is configured with the wireless control module (106) e.g. with Bluetooth and WiFi connectivity, a rechargeable lithium-ion battery (108) of 3.7V and 150mAh capacity is used to power the device (102). The system (100) of the present invention further comprises a remote-control unit (200) without limitation a smart phone with dedicated mobile application that allows the user to control and adjust vibration by controlling frequency of the miniature. Further the remote-control unit (200) acts as an interface for data analysis and desired data presentation for efficient and easy utilization of the system of the present invention.

[0070] According to another exemplary embodiment as shown in FIGs. 5 and 6, the portable and wearable system (100) for neuro modulation comprises two wearable devices (102) configured to be mounted on both the ears of the user (300), when the user is experiencing pain on both the side of the user’s face, head and neck region. The two wearable devices (102) are configured to be connected by a detachable, adjustable and foldable head / neck band (120) to securely hold the devices (102) at the desired position around the ear region of the user. The foldable and the head / neck band (120) comprises two terminal pieces (122a, 122b) with a “C shaped” holder (124a, 124b) at distal end to hold the two wireless devices (102) in position at both the ears of the user, and a central piece (126) of the head / neck band (120) is configured to snap fit the proximal ends of the two terminal pieces (122a, 122b) to provide detachable attachment of the head / neck band for easy and quick foldability and storage thus facilitate easy and quick pain management while travelling as well.

[0071] According to another exemplary embodiment, the portable and wearable system (100) of the present invention allows effective non-invasive and user-friendly pain management for neuropathic pain of the head and neck region in addition to trigeminal neuralgia. For Example, conditions such as diabetic neuropathy, postherpetic neuralgia, and other forms of nerve damage-related pain can be alleviated using the system (100) of the present invention. The system (100) also helps the user in reducing frequency and severity of migraines and cluster headaches.

[0072] According to another exemplary embodiment as shown in FIG. 8, the wearable system (100) for neuro modulation to control neuropathic pain is used by the user (300), wherein the device (102) is worn on both the ears (one side face of the user is shown) using the head / neck band (120).

[0073] Because many modifications, variations, and changes in detail can be made to the described preferred embodiments of the invention, it is intended that all matters in the foregoing description and shown in the accompanying drawings be interpreted as illustrative and not in a limiting sense. Thus, the scope of the invention should be determined by the appended claims and their legal equivalence.

Claims

CLAIMSWe Claim:

1. A portable and wearable system (100) for neuro modulation to control neuropathic pain, wherein the system (100) characterized in that comprises: a) at least one wearable device (102) that are provided with a rotatable and detachable ear loop (104) to hold the device (102) at the desired position around ear region of a user (300), wherein the device (102) comprises: i. at least one wireless enabled control module (106) powered by a power supply module (108) enclosed in a casing (110), wherein the casing is provided with an ear plug (112) to wear the device (102) on the ear of the user (300); ii. multiple adjustable miniature vibrators (114) functionally and detachably connected to the control module (106), wherein the vibrators (114) are provided with varying length of elongated bendable connector connectors (116) so as to position each of the vibrators (114) at targeted affected area of the user (300); and b) a remote-control unit (200) to wirelessly control functions of the control module (106) to control parameters including frequency, intensity, pulse duration, number of pulses, and time of operation of the multiple miniature vibrators (114) for automatic and effective pain management at the affected area of the user.

2. The portable and wearable system (100) for neuro modulation as claimed in claim 1, wherein each of the wearable device (102) comprises two clusters (114a-b) of miniature vibrators that are detachably connected with the control module, wherein each cluster (114a, 114b) comprises four miniature vibrators (114).

3. The portable and wearable system (100) for neuro modulation as claimed in claim 1, wherein the multiple miniature vibrators (114) are capable of operating at variablefrequencies ranging from 10 Hz to 100 Hz and amplitude / intensity ranging from 10- 45dB for a pulse duration ranging from 100ms to 1000ms.

4. The portable and wearable system (100) for neuro modulation as claimed in claim 1, wherein the system (100) comprises two wearable devices (102) configured to be mounted on both the ears of the user (300), wherein the two wearable devices (102) are configured to be connected by a detachable, adjustable and foldable head / neck band (120) to securely hold the devices (102) at the desired position around the ear of the user.

5. The head / neck band (120) for the portable and wearable system (100) for neuro modulation as claimed in claim 4, wherein the head / neck band (120) comprises two terminal pieces (122a, 122b) with a “C shaped” holder (124a, 124b) at distal end to hold the two wireless devices (102) in position at both the ears of the user, and a central piece (126) of the head / neck band (120) is configured to snap fit the proximal ends of the two terminal pieces (122a, 122b) to provide detachable attachment of the head / neck band for easy and quick foldability and storage.

6. The portable and wearable system (100) for neuro modulation as claimed in claim 1, wherein the remote-control unit (200) has one or more control switches (202) and a display (204) that acts as an interface to visualize to easily control the parameters including frequency, intensity, pulse duration, number of pulses, and time of operation of the multiple miniature vibrators (114).

7. The portable and wearable system (100) for neuro modulation as claimed in claim 1, wherein the remote-control unit (200) is a smart phone provided with a smartphone application that is configured to control the device(s) (102) wirelessly to adjust the parameters of the vibrators (114).

8. The portable and wearable system (100) for neuro modulation as claimed in claim 1, wherein the device (102) is provided with a charging port (117) and an ON / OFF switch (118).

9. The portable and wearable system (100) for neuro modulation as claimed in claim 1, wherein the power supply module (108) is a lithium-ion rechargeable battery.

10. The portable and wearable system (100) for neuro modulation as claimed in claim 1, wherein the ear plug (112) is made of silicone so as to act as a sound and vibration proof attachment for the user’s ear.

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