Sublingual light therapy system

Abstract

A sublingual light therapy system comprising a control unit and a mouthpiece operationally connected to the control unit and configured to be removably received at a specific position within the sublingual space of an oral cavity of a user, wherein the mouthpiece comprises two lateral light applicators configured to be located within opposing lingual sides of the lower teeth and gums of the oral cavity, and wherein each of the lateral light applicators comprises at least one light element configured to project light irradiation toward the ventral surfaces of the tongue, the lingual frenulum, and the floor of the mouth.

Description

SUBLINGUAL LIGHT THERAPY SYSTEMFIELD OF THE INVENTION

[0001] The invention relates generally to the field of devices and methods for light therapy.CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims the benefit of priority from U.S. Provisional Patent Application No. 63 / 575,888, filed April 8, 2024, entitled, “SUBLINGUAL LIGHT THERAPY DEVICE,” the contents of which are hereby incorporated herein by reference in their entirety.BACKGROUND

[0003] Light stimulus therapy, such as photobiomodulation (PBM), is an emerging medical technique which applies specific wavelengths of light to stimulate biological processes at the cellular level.

[0004] Light stimulus therapy has been studied in recent years in conjunction with skin treatments, muscle recovery, pain relief, enhancing cell functions, promoting tissue regeneration, mitigating inflammation, and boosting the immune system. Advances also have been made in studies that have sought to explain the mechanisms of action of light stimulus therapy at a molecular, cellular and tissue-based level. Generally, the induced benefits of light stimulus therapy have been found to depend on the parameters of its application, including wavelength, intensity, treatment duration, and treatment interval.

[0005] Among other benefits, light stimulus therapy has shown promising results in intraoral applications, and specifically, in the sublingual region, for neuromodulation and neurostimulation purposes. Neuromodulation relies on the body's natural biological response by stimulating nerve cell activity that can influence populations of nerves and modulate the excitability and firing patterns of neural circuits, which may bring about normalization of a neural network function from its disturbed state.

[0006] The highly vascularized and nerve -reach tissue beneath the tongue offers direct access to the nervous system and bloodstream, facilitating rapid absorption and systemic effects. Intraoral and sublingual light stimulus therapy applications have been shown to aid in recovery from nervous system injury, and to minimize and compensate for any functional alterations resulting from it.

[0007] The foregoing examples of the related art and limitations related therewith are intended to be illustrative and not exclusive. Other limitations of the related art will become apparent to those of skill in the art upon a reading of the specification and a study of the figures.SUMMARY

[0008] The following embodiments and aspects thereof are described and illustrated in conjunction with systems, tools and methods which are meant to be exemplary and illustrative, not limiting in scope.

[0009] There is provided, in an embodiment, a sublingual light therapy system comprising a control unit configured to generate control signals which determine operational parameters of the light therapy, and a mouthpiece operationally connected to the control unit and configured to be removably received at a specific position within the sublingual space of an oral cavity of a user, wherein the mouthpiece comprises two lateral light applicators configured to be located within opposing lingual sides of the lower teeth and gums of the oral cavity, and wherein each of the lateral light applicators comprises at least one light element configured to project light irradiation toward the ventral surfaces of the tongue, the lingual frenulum, and the floor of the mouth.

[0010] There is also provided, in an embodiment, a method for using a sublingual light therapy system comprising providing a system comprising: a control unit configured to generate control signals which determine operational parameters of the light therapy; and a mouthpiece operationally connected to the control unit and configured to be removably received at a specific position within the sublingual space of an oral cavity of a user, wherein the mouthpiece comprises two lateral light applicators configured to be located within opposing lingual sides of the lower teeth and gums of the oral cavity, and wherein each ofthe lateral light applicators comprises at least one light element configured to project light irradiation toward the ventral surfaces of the tongue, the lingual frenulum, and the floor of the mouth; positioning the mouthpiece in the specific position within the oral cavity; and operating the control unit to select operational parameters of the light therapy.

[0011] In some embodiments, the mouthpiece further comprises an anterior light applicator configured to be located within an anterior area of the sublingual space of the oral cavity, wherein the anterior light applicator comprises at least one light element configured to project light irradiation from toward the ventral surfaces of the tongue, the lingual frenulum, and the floor of the mouth.

[0012] In some embodiments, the mouthpiece is formed as a U-shaped member comprising an anterior portion comprising the anterior light applicator, and two lateral arms extending from opposing sides of the anterior portion in the posterior direction, wherein the two lateral arms comprise each a respective one of the lateral light applicators.

[0013] In some embodiments, the specific position is along a lingual side of the lower teeth and gums of the oral cavity.

[0014] In some embodiments, the at least one light element is selected from the group consisting of: light-emitting diode (LED), and laser diode.

[0015] In some embodiments, the at least one light element is a light element array comprising between 2-12 of the light elements.

[0016] In some embodiments, each of the one or more light elements is configured to emit light in one of the following wavelengths: 405 nm, 436 nm, 486 nm, 536 nm, 588 nm, 635nm, 656 nm, 660 nm, and 860 nm.

[0017] In some embodiments, the control unit comprises one or more of the following components: a microcontroller, a storage device, a light signal generator, a sensors module, a power source, and a communication module.

[0018] In some embodiments, wherein the operational parameters of the light therapy are selected from the group consisting of: total duration of the light irradiation, wavelengths of the light irradiation, intensity of the light irradiation, modulation patterns of the light irradiation, and total energy dose of the light irradiation.

[0019] In some embodiments, the mouthpiece comprises at least one sensor configured to measure at least one physiological, biochemical, and / or biomechanical parameters of the user, selected from the group consisting of: heart rate, heart rhythm, blood oxygen saturation, blood pressure, oral tissue light absorption rate, respiratory cycle, head and jaw motion, saliva chemistry, saliva impedance, and vocal patterns.

[0020] In some embodiments, the mouthpiece is operationally connected to the control unit via a wireless connection or via a cable connection.

[0021] There is further provided, in an embodiment, a sublingual light therapy device comprising: a mouthpiece configured to be removably received at a specific position within the sublingual space of an oral cavity of a user, wherein the mouthpiece comprises two lateral light applicators configured to be located within opposing lingual sides of the lower teeth and gums of the oral cavity, and wherein each of the lateral light applicators comprises at least one light element configured to project light irradiation toward the ventral surfaces of the tongue, the lingual frenulum, and the floor of the mouth.

[0022] In some embodiments, the mouthpiece further comprises an anterior light applicator configured to be located within an anterior area of the sublingual space of the oral cavity, wherein the anterior light applicator comprises at least one light element configured to project light irradiation from toward the ventral surfaces of the tongue, the lingual frenulum, and the floor of the mouth.

[0023] In some embodiments, the mouthpiece is formed as a U-shaped member comprising an anterior portion comprising the anterior light applicator, and two lateral arms extending from opposing sides of the anterior portion in the posterior direction, wherein the two lateral arms comprise each a respective one of the lateral light applicators.

[0024] In some embodiments, the specific position is along a lingual side of the lower teeth and gums of the oral cavity.

[0025] In some embodiments, the at least one light element is selected from the group consisting of: light-emitting diode (LED), and laser diode.

[0026] In some embodiments, the at least one light element is a light element array comprising between 2-12 of the light elements.

[0027] In some embodiments, each of the one or more light elements is configured to emit light in one of the following wavelengths: 405 nm, 436 nm, 486 nm, 536 nm, 588 nm, 635nm, 656 nm, 660 nm, and 860 nm.

[0028] In some embodiments, the mouthpiece is operationally connected to a control unit via a wireless connection or via a cable connection.

[0029] In some embodiments, the control unit comprises one or more of the following components: a microcontroller, a storage device, a light signal generator, a sensors module, a power source, and a communication module.

[0030] In some embodiments, the operational parameters of the light therapy are selected from the group consisting of: total duration of the light irradiation, wavelengths of the light irradiation, intensity of the light irradiation, modulation patterns of the light irradiation, and total energy dose of the light irradiation.

[0031] In some embodiments, the mouthpiece comprises at least one sensor configured to measure at least one physiological, biochemical, and / or biomechanical parameters of the user, selected from the group consisting of: heart rate, heart rhythm, blood oxygen saturation, blood pressure, oral tissue light absorption rate, respiratory cycle, head and jaw motion, saliva chemistry, saliva impedance, and vocal patterns.

[0032] Exemplary embodiments are illustrated in referenced figures. Dimensions of components and features shown in the figures are generally chosen for convenience and clarity of presentation and are not necessarily shown to scale. The figures are listed below:BRIEF DESCRIPTION OF THE DRAWINGS

[0033] FIG. 1A an exemplary system for delivering light stimulus directed at tissue surfaces in the sublingual space for therapeutical purposes, according to some embodiments of the present disclosure.

[0034] FIG. IB is a schematic block diagram of the exemplary system for delivering light stimulus directed at tissue surfaces in the sublingual space for therapeutical purposes, according to some embodiments of the present disclosure.

[0035] FIG. 1C is a schematic block diagram of the various components of the exemplary system for delivering light stimulus directed at tissue surfaces in the sublingual space for therapeutical purposes, according to some embodiments of the present disclosure.

[0036] FIGS. 2A-2D depict an exemplary mouthpiece of the present disclosure, in perspective, side, top, and bottom views.

[0037] FIGS. 3A-3C depict light irradiation patterns relative to a user’s oral cavity, which may be implemented using the exemplary mouthpiece of the present disclosure.

[0038] FIG. 4 A is a flowchart of the functional steps in a method for delivering light stimulus directed at tissue surfaces in the sublingual space for therapeutical purposes, according to some embodiments of the present disclosure.

[0039] FIG. 4B is a flowchart of the functional steps in a method for real-time measuring of a user’s physiological, biochemical, and / or biomechanical data using a plurality of intraoral sensors, and for detecting and / or predicting a health condition in the user based, at least in part, on the measured data.

[0040] FIGS. 4C-4D show exemplary sensor measurement data, according to some embodiments of the present disclosure.

[0041] FIGS. 5A-5B show a second variation of an exemplary mouthpiece of the present disclosure.

[0042] FIGS. 6A-6H show a second variation of an exemplary mouthpiece of the present disclosure in perspective exploded, back perspective, right front perspective, left front perspective, lingual side, buccal side, top, and bottom views, according to some embodiments of the present disclosure.

[0043] FIGS. 7A-7C show a second variation of an exemplary mouthpiece of the present disclosure in front perspective, back perspective, and side views, according to some embodiments of the present disclosure.

[0044] FIGS. 8A-8C show an exemplary separately-formed flange of the present variation exemplary mouthpiece, in front perspective, side, and top perspective views, according to some embodiments of the present disclosure.DETAILED DESCRIPTION

[0045] Disclosed herein are systems, devices, and methods for delivering light stimulus directed at tissue surfaces in the oral cavity for therapeutic purposes. In some embodiments, the present disclosure provides specifically for delivering light stimulus directed at specific sites in the sublingual space for therapeutical purposes. In some embodiments, the present disclosure provides specifically for delivering light stimulus directed at specific sites within the sublingual space, including the ventral surfaces of the tongue, both sides of the lingual frenulum, and the floor of the mouth. In some embodiments, such specific sites may coincide with one or more known acupuncture points in this area, such as EX-HN11, EX-HN12 and / or EX-HN 13.

[0046] In some embodiments, the present disclosure provides systems, devices, and methods for delivering light stimulus to intraoral, and particularly, sublingual, tissue sites, to promote neuromodulation and neurostimulation. In some embodiments, the present disclosure provides systems, devices, and methods for delivering light stimulus directed at specific sites within the sublingual space, including the ventral surfaces of the tongue, both sides of the lingual frenulum, and the floor of the mouth.

[0047] The present technique system and device provides for a safe and reliable means for applying light stimulus to a user, using a mouthpiece that is adapted and designed for precise delivery of stimulus to specific sites within the sublingual space of the user’s mouth, including the ventral surfaces of the tongue, both sides of the lingual frenulum, and the floor of the mouth. The present system and device are configured to be user-operated, generally after initial setup and configuration by a medical practitioner, based on a therapy regimen devised for the user, and do not require ongoing attention from a medical professional. The present system and device are also configured and dimensioned for prolonged intraoral usage (e.g., overnight, during sleep) in a way that does not disturb or cause undue discomfort to the user.

[0048] In some embodiments, the present system and device comprise a plurality of intraoral sensors configured for real-time monitoring and measuring of the user’s physiological, biochemical, and / or biomechanical data, including, but not limited to, vital signs, respiratory cycle, blood oxygen level, oral tissue light absorption rate, head motion,saliva chemistry, and / or vocal patterns. The data collected from these sensors may be analyzed, e.g., using a trained machine learning model, to detect and diagnose medical conditions, identify deviations from the user’s normal patterns, enable early detection of medical conditions, and tailor the therapy regimen to the individual user.

[0049] Light stimulus of sites in the oral cavity and sublingual space has been shown to be useful in improving a range of neurological-related impairments in users, including balance, gait, visual deficiencies, headache, migraines, neuropathic pain, hearing loss, speech recognition, auditory problems, speech therapy, blood pressure, and heart rate. Neuromodulation and neurostimulation of intraoral, and particularly, sublingual tissue surfaces have been shown to aid in rehabilitation and recovery from nervous system injuries and neurological impairment as a result of, e.g., traumatic brain injury, stroke, spinal cord injury, cerebral palsy, Parkinson's disease, multiple sclerosis, Alzheimer’s disease, and the like. Light stimulus of neural sites in the oral cavity and sublingual space have been shown to be useful in improving a range of neurological-related impairments in users, including balance, gait, visual deficiencies, headache, migraines, neuropathic pain, hearing loss, speech recognition, auditory problems, speech therapy, blood pressure, and heart rate.

[0050] As used herein, Tight stimulus’ or Tight therapy’ refers broadly to any noninvasive delivery or impingement of light targeted at a tissue surface, at controlled wavelengths, intensity, and / or duration. Light stimulus can include, but is not limited to, low-level laser therapy (LLLT), cold laser therapy, photobiomodulation (PBM), or red light therapy. The light stimulus can be emitted from any suitable light source, including, but not limited to, low-level (low-power) lasers or light-emitting diodes (LEDs).

[0051] As used herein, ‘neuromodulation’ and ‘neurostimulation’ broadly refer to the modulation or stimulation of nerve activity through targeted delivery of light stimulus, such as Light stimulus, to specific tissue surfaces or neurological sites in the body.

[0052] As used herein, ‘intraoral’ or ‘oral cavity’ refer broadly to any tissue surface within the human mouth, including, but not limited to, the hard palate, soft palate, uvula, inner cheeks, interior lips, medial and lateral surfaces of the gums, top and under surfaces of the tongue, and the floor of the mouth.

[0053] As used herein, the ‘sublingual space’ refers to the fascial area comprising the underside of the tongue, the floor of the mouth, and the inner or lingual-side surfaces of the lower gums. The sublingual space comprises a number of blood vessels and nerves, such as the lingual artery and nerve, the hypoglossal nerve and the glossopharyngeal nerve, which advantageously may be targeted for delivering light stimulus in accordance with various embodiments of the present disclosure.

[0054] As used herein, ‘anterior’ refers to portions of the mouth proximate the front of the mouth, such that the anterior direction extends toward the front of the mouth. ‘Posterior’ refers to the back of the mouth, such that the posterior direction extends toward the back of the mouth.

[0055] In one aspect, the present disclosure provides an intraoral device which may be removably received within the mouth of a user, and configured for delivering light stimulus directed at tissue surfaces or sites in the oral cavity, for therapeutic purposes. In some embodiments, the present disclosure provides an intraoral device which may be removably received within the mouth of a user, and configured for delivering light stimulus directed at tissue surfaces in the sublingual space, for therapeutical purposes. In some embodiments, the present disclosure provides an intraoral device which may be removably received within the mouth of a user, and configured for delivering light stimulus directed at specific tissue sites in the sublingual space, including the ventral surfaces of the tongue, both sides of the lingual frenulum, and the floor of the mouth. In some embodiments, such specific sites may coincide with one or more known acupuncture points in this area, such as EX-HN 11 , EX- HN 12 and / or EX-HN 13.

[0056] In some embodiments, the present intraoral device comprises a mouthpiece adapted to be removably received within the mouth of a user, so as to be positioned in a specific orientation relative to the oral cavity of the user. In some embodiments, the present intraoral device comprises a mouthpiece adapted to be removably seated or fit inside and along at least part of an inner surface of the user's teeth and gums, e.g., the inner lower dental arch, in the sublingual space. In some embodiments, one or more portions of the mouthpiece can be adapted to be bitten or clamped by the occlusal of the teeth.

[0057] In some embodiments, the present intraoral device comprises a mouthpiece adapted to be removably seated or fit over one or more features or tissues of the mouth of the user, so as to be positioned in a specific orientation relative to the oral cavity of the user. In one example, the present mouthpiece may be adapted to be seated over or fit around intraoral surfaces or features comprising hard tissues (i.e., teeth / dentition) and / or soft tissues (i.e., gums), so as to be positioned in a specific orientation relative to the oral cavity of the user. In some embodiments, the present mouthpiece may be adapted to fit over temporary, permanent, and / or artificial dentition of a user. In one example, the present mouthpiece is adapted be seated over a section of the lower jaw of the user.

[0058] The present mouthpiece may be customized to an individual user's mouth, such that it provides for a comfortable fit around surfaces of hard tissues (i.e., teeth / dentition) and / or soft tissues (i.e., gums) of the individual user’s mouth. In some embodiments, the present mouthpiece may be made in various sizes to provide for a comfortable fit to, e.g., adults, children, etc.

[0059] The present mouthpiece can be formed of any suitable material, such as polymers, thermoplastics, acrylics, silicone, rubber, metal wires or any other material that can be used to form the present mouthpiece.

[0060] The present mouthpiece has a form to permit stable positioning with respect to at least a part thereof within a user's mouth, such that it can remain positioned in a specific orientation relative to the oral cavity of the user. In one example, the present mouthpiece is formed as a generally U-shaped member, having an anterior portion which extends around anterior portions of the user's mouth, and two lateral arms extending from opposing sides of the anterior portion in the posterior direction, toward the posterior of the mouth. For example, the anterior portion may be configured to be received within the anterior section of the mouth, e.g., at least partially behind the front lower teeth. The lateral arms of the mouthpiece may thus extend in the posterior direction inside and along the lingual side of the user's lower teeth and gums. In another example, one or more portions of the mouthpiece can be adapted to be seated on sections of the user’s dentition, e.g., comprising one or more teeth of the user’s lower dental arch. In yet another example, one or more portions of the mouthpiece can be adapted to be bitten or clamped by the occlusal of the teeth.

[0061] In some embodiments, the present intraoral device comprises one or more light or irradiation elements configured to project light to sites within the sublingual space of the user’s mouth, including the underside of the tongue, the floor of the mouth, and the inner or lingual-side surfaces of the lower gums. In some embodiments, the present intraoral device comprises one or more light or irradiation elements configured to project light to specific sites within the sublingual space, including the ventral surfaces of the tongue, both sides of the lingual frenulum, and the floor of the mouth.

[0062] In some embodiments, the present intraoral device comprises one or more sensors configured attached to or embedded in specified locations of the mouthpiece. The one or more sensors are configured to collect measurements relating to the user’s measuring of the user’s physiological, biochemical, and / or biomechanical data, including, but not limited to, vital signs, respiratory cycle, blood oxygen level, head motion, saliva chemistry, and / or vocal patterns.

[0063] In some embodiments, the present intraoral device comprises one or more user interface means, including, but not limited to, one or more buttons or switches for operating and controlling the device, as well as one or more means for providing visual and / or audio indications regarding the status and operation of the device.

[0064] In some embodiments, the present intraoral device comprises a control unit operationally connected to the mouthpiece and configured to control the operation of the various components of the device. For example, the control unit is configured to generate and send electrical control signals which determine various parameters of the operation of the light elements, such as wavelengths, intensity and duration of the light stimulus delivered by the light elements. The control unit is also configured to collect and store measurement data from the one or more sensors, as well as demographic, clinical, and related information about the user of the intraoral device.

[0065] In some embodiments, the control unit comprises various electronics and operational components, including, but not limited to, control circuitry, a power source such as a rechargeable battery, data storage, wired or wireless transceiver, user interface comprising one or more switches and / or means for visual or audio indication, and power and / or data terminals.

[0066] In some embodiments, at least some of the electronics and operational components of the control unit may be housed within a dedicated area of the mouthpiece, e.g., in an anterior portion of the mouthpiece. However, in some embodiments at least some of the electronics and operational components of the control unit may be located in a dedicated unit which may be extra-oral and which may be connected to the mouthpiece wirelessly or via a suitable fixed or detachable data and / or power cable. For example, the dedicated control unit may include one or more of the control circuit, rechargeable battery or similar power source for powering the intraoral device, data storage, wired or wireless transceiver, one or more switches, and / or power and / or data terminals.

[0067] In another aspect, the present disclosure provides a system for delivering light stimulus directed at tissue surfaces or sites in the oral cavity, for therapeutic purposes. In some embodiments, the present system is configured for delivering light stimulus directed at tissue surfaces in the sublingual space, for therapeutical purposes. In some embodiments, the present system is configured for delivering light stimulus directed at specific tissue sites in the sublingual space, including the ventral surfaces of the tongue, both sides of the lingual frenulum, and the floor of the mouth. In some embodiments, such specific sites may coincide with one or more known acupuncture points in this area, such as EX-HN11, EX-HN12 and / or EX-HN 13.

[0068] In some embodiments, the present system comprises an intraoral mouthpiece which may be removably received within the mouth of a user, and an external control unit which is operationally connected to the mouthpiece. In some embodiments, the mouthpiece is configured for being removably received within the mouth of a user, and for delivering light stimulus directed at specific tissue sites in the sublingual space, for therapeutical purposes. In some embodiments, the present mouthpiece may be removably received within the mouth of a user, and configured for delivering light stimulus directed at specific tissue sites in the sublingual space, including the ventral surfaces of the tongue, both sides of the lingual frenulum, and the floor of the mouth. In some embodiments, such specific sites may coincide with one or more known acupuncture points in this area, such as EX-HN11, EX-HN 12 and / or EX-HN 13.

[0069] In some embodiments, the present mouthpiece is adapted to be removably received within the mouth of a user, so as to be positioned in a specific orientation relative to the oral cavity of the user. In some embodiments, the present mouthpiece is adapted to be removably seated or fit inside and along an inner surface of the user's teeth and gums in the sublingual space. In some embodiments, one or more portions of the mouthpiece can be adapted to be bitten or clamped by the occlusal of the teeth.

[0070] In some embodiments, the mouthpiece is adapted to be removably seated or fit over one or more features or tissues of the mouth of the user, so as to be positioned in a specific orientation relative to the oral cavity of the user. In one example, the present mouthpiece may be adapted to be seated over or fit around intraoral surfaces or features comprising hard tissues (i.e., teeth / dentition) and / or soft tissues (i.e., gums), so as to be positioned in a specific orientation relative to the oral cavity of the user. In some embodiments, the present mouthpiece may be adapted to fit over temporary, permanent, and / or artificial dentition of a user. In one example, the present mouthpiece is adapted be seated over a section of the lower jaw of the user.

[0071] The mouthpiece may be customized to an individual user's mouth, such that it provides for a comfortable fit around surfaces of hard tissues (i.e., teeth / dentition) and / or soft tissues (i.e., gums) of the individual user’s mouth. The present mouthpiece can be formed of any suitable material, such as polymers, thermoplastics, acrylics, silicone, rubber, metal wires or any other material that can be used to form the present mouthpiece.

[0072] The present mouthpiece has a form to permit stable positioning at least partially within a user's mouth, such that it can remain positioned in a specific orientation relative to the oral cavity of the user. In one example, the present mouthpiece is formed as a generally U-shaped member, having an anterior portion which extends around anterior portions of the user's mouth, and two lateral arms extending from opposing sides of the anterior portion in the posterior direction, toward the posterior of the mouth. For example, the anterior portion may be configured to be received within the anterior section of the mouth, e.g., at least partially behind the front lower teeth. The lateral arms of the mouthpiece may thus extend at least partly in the posterior direction inside and along the lingual side of the user's lower teeth and gums. In another example, one or more portions of the mouthpiece can be adaptedto be seated on sections of the user’s dentition, e.g., comprising one or more teeth of the user’s lower dental arch. In yet another example, one or more portions of the mouthpiece can be adapted to be bitten or clamped by the occlusal of the teeth.

[0073] In some embodiments, the present mouthpiece comprises one or more light or irradiation elements configured to project light to sites within the sublingual space of the user’s mouth, including the ventral surfaces of the tongue, both sides of the lingual frenulum, and the floor of the mouth. In some embodiments, the present mouthpiece comprises one or more light or irradiation elements configured to project light to specific sites within the sublingual space, including the ventral surfaces of the tongue, both sides of the lingual frenulum, and the floor of the mouth. In some embodiments, such specific sites may coincide with one or more known acupuncture points in this area, such as EX-HN11, EX-HN12 and / or EX-HN 13.

[0074] In some embodiments, the present mouthpiece comprises one or more sensors configured attached to or embedded in specified locations of the mouthpiece. The one or more sensors are configured to collect measurements relating to the user’s measuring of the user’s physiological, biochemical, and / or biomechanical data, including, but not limited to, vital signs, respiratory cycle, blood oxygen level, head motion, saliva chemistry, and / or vocal patterns.

[0075] In some embodiments, the present system comprises a control unit operationally connected to the mouthpiece and configured to control the operation of the various components of the system. For example, the control unit is configured to generate and send electrical control signals which determine various parameters of the operation of the light elements of the mouthpiece, such as wavelengths, intensity and duration of the light stimulus delivered by the light elements. The control unit is also configured to collect and store measurement data from the one or more sensors, as well as demographic, clinical, and related information about the user of the system.

[0076] In some embodiments, control unit may comprise a dedicated unit which may be operationally connected to the mouthpiece wirelessly, or via a suitable fixed or detachable data and / or power cable. In some embodiments, the control unit comprises various electronics and operational components, including, but not limited to, control circuitry, apower source such as a rechargeable battery, data storage, wired or wireless transceiver, a user interface, and power and / or data terminals. However, in some embodiments, one or more of these electronics and operational components may be housed within the mouthpiece. In another example, both of the control unit and the mouthpiece may comprise duplicate ones of these electronics and operational components. For example, both of the control unit and the mouthpiece may comprise data storage, a wired or wireless transceiver, and / or a power source.

[0077] In some embodiments, the control unit comprises one or more user interface means, which may include, but are not limited to, one or more buttons or switches for operating and controlling the system, a display screen, as well as one or more means for providing visual and / or audio indications regarding the status and operation of the system.

[0078] Reference is made to FIG. 1A which illustrates an exemplary system 100 for delivering light stimulus directed at tissue surfaces in the sublingual space for therapeutical purposes, according to some embodiments of the present disclosure. Reference is also made to FIG. IB which is a schematic block diagram of system 100, and to FIG. 1C which is a schematic block diagram of the various components of system 100.

[0079] System 100 comprises a mouthpiece, such as exemplary mouthpiece 102, that is adapted and designed to be received within a user’s mouth, for precise delivery of light stimulus to specific sites within the sublingual space of a user’s mouth, and a control unit 122 operationally connected to mouthpiece 102 and configured to control the operation of mouthpiece 102 and the various components of system 100.

[0080] Control unit 122 may comprise a dedicated extra-oral unit which may be operationally connected to mouthpiece 102. However, in some embodiments, at least some of the functions of control unit 122 may be implemented as a software agent within an external device, such as a smartphone, a smartwatch, a tablet, a personal computer, or the like.

[0081] In some embodiments, control unit 122 may be operationally connected to mouthpiece 102 wirelessly or via a suitable fixed or detachable connecting cable 120. Connecting cable 120 is configured for connecting to mouthpiece 102 at a power and / or data terminal 104a located at an anterior portion 104 of mouthpiece 102, for transmitting controlsignals, data, and / or electrical power between control unit 122 and mouthpiece 102. However, in some variations, control unit 122 may be operationally connected to mouthpiece 102 wirelessly, using any suitable or desirable short-range communication protocol. In such examples, mouthpiece 102 may have a power source integrated within mouthpiece 102.

[0082] In some embodiments, control unit 122 comprises a microcontroller 124 which includes one or more hardware processor(s) and one or more non-transitory computer- readable storage device(s), such as storage device 124a.

[0083] Storage device 124a may have stored thereon program instructions configured to operate control unit 122. The program instructions may include one or more software modules, which may include an operating system having various software components and / or drivers for controlling and managing general system tasks (e.g., memory management, storage device control, power management, etc.), and facilitating communication between various hardware and software components.

[0084] Control unit 122 includes a light signal generator 126. Light signal generator 126 is configured to generate the necessary signals to control the light elements 112 within mouthpiece 102, and / or to provide a source of power to drive the light elements 112. In some embodiments, light signal generator 126 generates sequences of light therapy patterns, which may be generated ad-hoc or according to predetermined therapy protocols. The light therapy patterns are defined by operating parameters including total duration, wavelengths, intensity (brightness), modulation pattern and frequency, and therapeutic dose (total energy). In some embodiments, therapy protocol parameters may include, but are not limited to:A number of therapy sessions in a given time period (e.g., day, week, month).Overall therapy session duration.Therapy session timing reference (e.g., time of day, user resting status, user activity status, other signals and / or reference activities, such as cardiac activity in the user).Total light irradiation duration during each therapy session.Maximum, minimum, and mean light irradiation intensity (i.e., brightness).Maximum, minimum, and mean light irradiation output power or energy.Light irradiation wavelength or combination of wavelengths.Light irradiation modulation pattern.

[0085] In some embodiments, control unit 122 may include a sensors module 128 configured to operationally connect to and control a sensors array 114 of mouthpiece 102, as well as one or more additional optional sensors located at control unit 122.

[0086] In some embodiments, control unit 122 includes a power management module 130 configured to control and manage power supply to control unit 122 and to mouthpiece 102, e.g., via cable 120. Power management module 130 may be operationally connected to and configured to control a power supply 130a, which may include a rechargeable battery or similar power source, and a charger.

[0087] In some embodiments, control unit 122 includes a user interface 134 which may include a small display screen 134a, which is optionally a touchscreen. User interface 134 may also include means, such as buttons and / or switches 134b, for operating and controlling system 100 by a user, as well as one or more visual and / or audio indications regarding the operating status of system 100. In some embodiments, user interface 134 allows a user to select, configure, and schedule therapy treatments or sessions from available protocol libraries, and to start, pause, or terminate treatments.

[0088] In some embodiments, control unit 122 includes a communication module 136 configured to send information to, and / or receive information from, an external agent, such as a smartphone, a smartwatch, a tablet, a personal computer, and / or a remote server. Communication module 136 may be operationally connected to an antenna 136a. The sending and the receiving of information may be implemented wirelessly, using, e.g., longdistance wireless communication (e.g., to a user’s cloud storage, a user’s personal computer, a computer system of the user’s healthcare provider, and / or a personal computer of the user’s physician / caregiver), by means of cellular networks, and / or Wi-Fi. Alternatively or additionally, communication module 136 may be configured for short-range communication (e.g., to the user’s smartphone or tablet), for example, by means of Bluetooth, NFC (near field communication) technology, and / or Wi-Fi. In particular, in some embodiments, communication module 136 may be used to relay information from control unit 122 to a user’s smartphone / smartwatch and to relay commands from the user’ssmartphone / smartwatch to control unit 122, thereby facilitating controlling and operating by means of the smartphone / smartwatch.

[0089] In some embodiments, control unit may also include a data logger functionality for logging information related to the user, a history of therapy sessions, and related physiological parameters of the user. In some embodiments, the data logger may store this information in a database maintained on storage device 124a.

[0090] Control unit 122 as described herein is only an exemplary embodiment of the present invention, and in practice may be implemented in any combination of hardware and software components. Control unit 122 may have more or fewer components and modules than shown, may combine two or more of the components, or may have a different configuration or arrangement of the components.

[0091] In some embodiments, one or more components or functions of control unit 122 may be co-located or distributed within system 100, e.g., to mouthpiece 102, and / or externally of system 100. In some variations, mouthpiece 102 may comprise duplicate one or more components corresponding to the components of control unit 100, such as a rechargeable power source and power management functions, a communication module or a transceiver configured to communicate wirelessly with control unit 122 and / or another external device, and / or simple user interface functions.

[0092] For example, in some embodiments, mouthpiece 102 may be a passive component of system 100 which comprises a passive array of light elements powered, controlled and driven via control unit 122. However, in other examples, mouthpiece 102 is not a passive component of system 100, but rather comprises local signal generation capabilities using, e.g., an integrated microcontroller, memory storage device, light element drive electronics, a rechargeable power source, and / or a communication transceiver or bus interface with control unit 122. In these variations, mouthpiece 102 may be able to independently produce light therapy schedules and patterns. Thus, rather than using a centralized control function in control unit 122, system 100 may employ a distributed architecture comprising a network of autonomous components. In such architecture, the role of control unit 122 includes that of a user interface, allowing a user to select therapy treatments or sessions from available protocol libraries, and to start, pause, or terminate treatments. In such embodiments, thecommunication of electrical signal between control unit 122 and mouthpiece 102 over cables 122 will be replaced with, e.g., command-based instructions.

[0093] Mouthpiece 102 will now be described in detail, with continued reference to FIGS. 1A-1C, and with reference to FIGS. 2A-2D which depict mouthpiece 102 in perspective, side, top, and bottom views.

[0094] In some embodiments, mouthpiece 102 is configured to be removably received within the mouth of a user, and to deliver light stimulus directed at tissue surfaces or sites in the sublingual space, for therapeutical purposes.

[0095] In some embodiments, mouthpiece 102 is adapted to be removably received within the mouth of a user, so as to be positioned in a specific orientation relative to the oral cavity of the user.

[0096] In some embodiments, mouthpiece 102 adapted to be removably seated or fit over one or more features or tissues of the mouth of the user, so as to be positioned in a specific orientation relative to the oral cavity of the user. In one example, the present mouthpiece may be adapted to be seated over or fit around intraoral surfaces or features comprising hard tissues (i.e., teeth / dentition) and / or soft tissues (i.e., gums), so as to be positioned in a specific orientation relative to the oral cavity of the user. In some embodiments, the present mouthpiece may be adapted to fit over temporary, permanent, and / or artificial dentition of a user. In one example, the present mouthpiece is adapted be seated over a section of the lower jaw of the user.

[0097] In some embodiments, mouthpiece 102 is adapted to be removably seated or fit inside and along the lingual side of the user's lower teeth and gums, within the sublingual space. In some embodiments, one or more portions of mouthpiece 102 can be adapted to be bitten or clamped by the occlusal of the teeth.

[0098] Mouthpiece 102 may be customized to an individual user's mouth, such that it provides for a comfortable fit around surfaces of hard tissues (i.e., teeth / dentition) and / or soft tissues (i.e., gums) of the individual user’s mouth. Mouthpiece 102 can be formed of any suitable material, such as polymers, thermoplastics, acrylics, silicone, rubber, metal wires or any other material that can be used to form mouthpiece 102.

[0099] Mouthpiece 102 has a form to permit stable positioning at least partially within a user's mouth, such that it can remain positioned in a specific orientation relative to the oral cavity of the user.

[0100] In one example, mouthpiece 102 is formed as a generally U-shaped member. Mouthpiece 102 has an anterior portion 104 which extends externally of the user’ s mouth, and comprises a power and / or data terminal 104a located at an anterior extraoral end of anterior portion 104 of mouthpiece 102.

[0101] Mouthpiece 102 comprises an anterior light applicator 106. In some embodiments, anterior light applicator 106 may define a small body or housing having an interior space. When mouthpiece 102 is received within a user’s mouth, anterior light applicator 106 is configured to be located within an anterior area of the sublingual space behind the front lower teeth. Thus, as shall be further explained hereinbelow, anterior light applicator 106 is configured and positioned to project light irradiation from an anterior aspect in one or more directions toward specific sites within at least the anterior area of the sublingual space of the mouth of the user. These sites may include the ventral surfaces of the tongue, both sides of the lingual frenulum, and the floor of the mouth. In some embodiments, such specific sites may coincide with one or more known acupuncture points in this area, such as EX-HN 11 , EX-HN12 and / or EX-HN 13.

[0102] In some embodiments, anterior light applicator 106 may be operationally connected to and controlled by control unit 122, e.g., wirelessly or via a suitable cable connected to terminal 104a. Anterior light applicator 106 may comprise one or more, e.g., an array, of light elements 112 positioned and configured so as to project light irradiation in one or more directions toward sites within at least the anterior area of the sublingual space and floor of the mouth of the user, including the ventral surfaces of the tongue, both sides of the lingual frenulum, and the floor of the mouth. In some embodiments, such specific sites may coincide with one or more known acupuncture points in this area, such as EX-HN11, EX-HN 12 and / or EX-HN 13.

[0103] In some embodiments, anterior light applicator 106 may comprise one or more electronics or components of system 100, which may be co-located or distributed within system 100, as described above with reference to FIGS. 1A-1C. For example, anterior lightapplicator 106 may comprise local signal generation capabilities using, e.g., an integrated microcontroller, memory storage device, light element drive electronics, and a communication transceiver or bus interface with control unit 122.

[0104] Mouthpiece 102 may further comprise two lateral arms 108a, 108b extending from opposing lateral sides of anterior portion 104, in the posterior direction, toward the posterior of the mouth. Lateral arms 108a, 108b of mouthpiece 102 may thus extend in the posterior direction laterally inside along the lingual side of the user's lower teeth and gums within the sublingual space. However, in one example, one or more portions of mouthpiece 102 or lateral arms 108a, 108b can be adapted to be at least partially seated on sections of the user’s lower dentition and / or comprise portions configured to be bitten or clamped by the occlusal of the teeth.

[0105] Lateral arms 108a, 108b each terminates in corresponding lateral light applicators 109a, 109b, each defining a small body or housing having an interior space, lateral light applicators 109a, 109b are configured to have at least a lower portion thereof located within the lingual side of the user's lower teeth and gums within the sublingual space. Each of lateral light applicators 109a, 109b is configured to be located at a specified location along the lingual side of the user's lower teeth and gums such that it is configured to project light irradiation toward specific sites within the respective lingual sides of the sublingual space and floor of the mouth of the user from a mid-lateral aspect. In some embodiments, these sites include the ventral surfaces of the tongue, both sides of the lingual frenulum, and the floor of the mouth. In some embodiments, such specific sites may coincide with one or more known acupuncture points in this area, such as EX-HN11, EX-HN12 and / or EX-HN13.

[0106] In some embodiments, lateral light applicators 109a, 109b may be operationally connected to and controlled by control unit 122, e.g., via terminal 104a and lateral arms 108a, 108b. lateral light applicators 109a, 109b may each comprise one or more, e.g., an array, of light elements 112 positioned and configured so as to project light irradiation in one or more directions toward sites within the respective lingual sides of the sublingual space and floor of the mouth of the user.

[0107] In some embodiments, one or both of lateral light applicators 109a, 109b may comprise one or more electronics or components of system 100, which may be co-located ordistributed within system 100, as described above with reference to FIGS. 1A-1C. For example, one or both of lateral light applicators 109a, 109b may comprise local signal generation capabilities using, e.g., an integrated microcontroller, memory storage device, light element drive electronics, and a communication transceiver or bus interface with control unit 122.

[0108] In some embodiments, mouthpiece 102 may be integrally-formed as a single-piece from a single material. Alternatively, various portions of the mouthpiece 102 may be composed of one or more different materials, or one or more layers of materials. These materials can include various forms of silicon; ethyl-vinyl acetate (EVA); thermoplastic polyolefin, various ethylene-based plasterers; various hydrocarbon resins (which are may be combined with EVA, thermoplastic polyolefin, or various ethylene-based elastomers), polycaprolactone (which may be combined with EVA), low-density polyethylene, high density poly-ethylene, polycarbonate and / or various polymers, laminates and other materials that will be recognized by those skilled in the art upon review of the present disclosure.

[0109] In some embodiments, mouthpiece 102 may be produced in a variety of sizes to fit the oral anatomy and dimensions of different users. The mouthpiece 102 may be customized to fit the oral anatomy and dimensions of different users. In some embodiments, mouthpiece 102 may be constructed of a heat-formable polymer that softens when heated to allow the elongated body to be customized to a user's mouth.

[0110] Reference is made to FIGS. 3A-3C which depict light irradiation patterns relative to a user’s oral cavity, which may be implemented using mouthpiece 102.

[0111] As noted above, mouthpiece 102 comprises anterior light applicator 106. As shown in FIG. 3 A in top view, when mouthpiece 102 is received within a user’s mouth, anterior light applicator 106 is configured to be located, at least with respect to a lower portion thereof, within an anterior area of the sublingual space behind the front lower teeth, e.g., opposite an anterior ventral surface of the user’s tongue and above the floor of the oral cavity and the lingual frenulum.

[0112] Thus, anterior light applicator 106 is configured and positioned to project light irradiation from an anterior aspect in one or more directions toward sites within at least theanterior area of the sublingual space and floor of the mouth of the user, as shown by the direction of the arrows in FIGS. 3A-3C.

[0113] Similarly, lateral arms 108a, 108b of mouthpiece 102 extend in the posterior direction inside along the lingual side of the user's lower teeth and gums within the sublingual space. Lateral light applicators 109a, 109b are configured to have at least a lower portion thereof located within the lingual side of the user's lower teeth and gums within the sublingual space. Thus, lateral light applicators 109a, 109b are configured and positioned to project light irradiation from opposing lateral aspects in one or more directions toward sites within the respective lingual sides of the sublingual space and floor of the mouth of the user, as shown by the direction of the arrows in FIGS. 3A-3C.

[0114] As shown in FIG. 3C, anterior light applicator 106 and lateral light applicators 109a, 109b each comprises one or more, e.g., an array, of light elements 112 positioned and configured so as to project light irradiation in one or more directions, toward sites within at least the anterior area of the sublingual space and floor of the mouth of the user. Thus, light elements 112 in anterior light applicator 106 are configured to project light irradiation in one or more directions, generally downwardly toward sites within at least the anterior area of the sublingual space and floor of the mouth of the user, as shown by the direction of the arrows in FIGS. 3A-3C. Light elements 112 in lateral light applicators 109a, 109b are configured and positioned to project light irradiation in one or more directions, generally downwardly toward sites within the respective lingual sides of the sublingual space and floor of the mouth of the user, as shown by the direction of the arrows in FIGS. 3A-3C. These sites include the underside of the user’s tongue, the floor of the user’s mouth, and / or the medial surface of the lower jaw of the user.

[0115] In some embodiments, each of anterior light applicator 106 and / or lateral light applicators 109a, 109b comprises one or more, e.g., an array, of light elements 112 arranged in a predetermined pattern therein. In some embodiments, each of anterior light applicator 106 and / or lateral light applicators 109a, 109b comprises, e.g., 1, 2, 3, 4, 5, 6, 8, 10, 12, or more light elements 112.

[0116] In some embodiments, light elements 112 may comprise any suitable type of light elements 112 configured to emit light in a specific wavelength or in a specific band ofwavelengths. Accordingly, in some embodiments, light elements 112 may comprise any suitable combination of one or more light-emitting diodes (LEDs) and / or laser diodes.

[0117] In some embodiments, one or more of the light elements 112 may be configured to emit light in any one of the wavelengths 405 nm, 436 nm, 486 nm, 536 nm, 588 nm, 635nm, 656 nm, 660 nm and 860 nm. In some embodiments, each light element 112 may be configured to emit light having a wavelength within the red to infra-red range. In some embodiments, each light element 112 may be configured to emit light at a wavelength between 600 and 1200 nm, between 600 and 700 nm, between 700 and 800 nm, between 800 and 820 nm, between 820 and 850 nm, between 800 and 850 nm, between 850 and 900 nm, between 900 and 1000 nm, between 1000 and 1100 nm, between 1100 and 1200 nm, between 1200 and 1300 nm, between 1300 and 1400 nm, between 1400 and 1500 nm, including any range therebetween. In some embodiments, the wavelength range may be, e.g., between 780-1400 nm, 1400-3000 nm, 1000-3000 nm, 800-2500 nm, 2.5-50 um, and / or 50- 2000 um.

[0118] In some embodiments, light elements 112 are arranged in arrays within each of anterior light applicator 106 and / or lateral light applicators 109a, 109b. In some embodiments, each light elements 112 array may be arranged in the form of one or more rows, one or more columns, a rectangle, or in a circular, oval, triangular, polygonal, or horseshoe shape. In some embodiments, each light elements 112 array may define a planar array, or else may define a non-planar array, e.g., having a surface curvature in one or more directions.

[0119] In some embodiments, light elements 112 arrays may be located within an interior space defined by anterior light applicator 106 and / or lateral light applicators 109a, 109b, respectively. In such cases, for example, one or more portions of the outer walls of anterior light applicator 106 and / or lateral light applicators 109a, 109b, as the case may be, is suitably transparent to allow the passage of light irradiation from the light elements 112 array therethrough.

[0120] In each case, the light elements 112 arrays are positioned and oriented so as to project light irradiation in one or more directions toward predetermined sites within therespective lingual sides of the sublingual space and floor of the mouth of the user, as shown by the direction of the arrows in FIGS. 3A-3C.

[0121] In other cases, light elements 112 arrays may be fixedly or adjustably arranged on or attached to one or more external surfaces of anterior light applicator 106 and / or lateral light applicators 109a, 109b, respectively. In the case where light elements 112 arrays may be adjustably attached to one or more external surfaces of anterior light applicator 106 and / or lateral light applicators 109a, 109b, a projections orientation of each light element 112 may be adjusted in relation to a plane of the array as a whole. For example, a projection orientation of one or more of the light elements 112 relative to the sublingual space is adjustable by varying a dimension or shape of anterior light applicator 106 and / or lateral light applicators 109a, 109b, as the case may be, so as to allow mouthpiece 102 to be customized to the oral cavity anatomy of a particular user.

[0122] In some embodiments, the plurality of light elements 112 comprising each array may be all oriented so as to emit a plurality of light beams forming a single cone beam. In some embodiments, the cone beam has a convergence point, e.g., a vertex, which is directed at a predetermined site in the sublingual space.

[0123] With continued reference to FIGS. 1A-1C and 2A-2D, in some embodiments, system 100 comprises a plurality of sensors configured for real-time monitoring and measuring of the user’s physiological, biochemical, and / or biomechanical data, including, but not limited to, vital signs, respiratory cycle, blood oxygen level, head motion, saliva chemistry, and / or vocal patterns.

[0124] In some embodiments, the plurality of sensors are used for non-invasive monitoring of the user’s health and physical status, specifically, to assist in managing neurological conditions (like Parkinson’s disease, epilepsy, etc.) and chronic diseases (diabetes, heart disease, etc.), for example, saliva sensors, temperature sensors, light (optical) sensors, and / or movement sensors can each play unique a role in detecting and tracking physiological changes. By capturing biochemical or physical signals from the body, these sensors help reflect a patient’s condition in real time. The data collected by the sensors can be analyzed, e.g., using one or more trained machine learning models, to identify patterns, enable early detection of problems, and provide personalized health insights.

[0125] In some embodiments, the plurality of sensors may be located within mouthpiece 102, as part of sensors array 114. However, in some embodiments, at least one additional sensor is located within control unit 122. In some embodiments, at least one of the sensors comprising sensors array 114 may be duplicated in control unit 122.

[0126] In some embodiments, sensors module 128 of control unit 122 is configured to operationally connect to and control a sensors array 114 of mouthpiece 102, as well as one or more additional optional sensors located at control unit 122. In some embodiments, sensors module 128 is configured to operationally control sensors array 114 to continuously or periodically measure a plurality of biochemical or physical signals from the user’s body, including signals associated with one or more of vital signs, respiratory cycle, blood oxygen level, head motion, and saliva chemistry.

[0127] In some embodiments, sensors module 128 of control unit 122 is configured to receive the data collected via the plurality of sensors. In some embodiments, sensors module 128 of control unit 122 is configured to record and store the collected data, e.g., on storage device 124a. In some embodiments, at least part of the collected sensor data may be transmitted, e.g., via communication module 136, to an external agent, such as a smartphone, a smartwatch, a tablet, a personal computer, and / or a remote server.

[0128] Accordingly, in some embodiments, system 100 100 (e.g., sensors array 114 of mouthpiece 102) comprises one or more of the following sensors:Saliva chemistry sensor: In some embodiments, system 100 (e.g., sensors array 114 of mouthpiece 102) comprises at least one sensor configured to continuously analyze and measure one or more values associated with the user’s saliva. These values include, but are not limited to, salivary flow rate, salivary osmolality, concentration of salivary electrolytes, an impedance or conductivity value of the user’s saliva, and / or concentrations of one or more chemicals, hormones, metabolites, and / or proteins.In one example, the at least one saliva sensor may comprise a pair of electrodes 110 (shown in FIGS. 2A and 2C), located on an external surface of anterior light applicator 106. For example, electrodes 110 located on a top external surface of anterior light applicator 106. Electrodes 110 are configured measure an impedanceor conductivity value of the user’s saliva. For example, the pair of electrodes 110 may include a detection electrode and a reference electrode. To analyze a saliva sample making contact with electrodes 110, sensors module may transmit an analog signal at one or more predetermined working frequencies, and measure an output signal to determine salivary electrolyte concentration. The output measurement may provide an indication regarding saliva composition, which in turn has been shown to associated with certain systemic conditions, such as diabetes, chronic kidney disease, neurological disorders, chronic stress or anxiety levels, and dental diseases.PPG sensor: In some embodiments, system 100 (e.g., sensors array 114 of mouthpiece 102) comprises at least one photoplethysmography (PPG) sensor configured to continuously monitor and measure heart rate and rhythm, blood oxygen saturation, and / or estimate blood pressure. These data can be used to detect arrhythmias as atrial fibrillation, monitor oxygen saturation for chronic respiratory diseases or heart failure, monitor gingival blood perfusion or detect early inflammation, dental pulp vitality.Light / optical sensor: In some embodiments, system 100 (e.g., sensors array 114 of mouthpiece 102) comprises at least one light or optical sensor configured to measure oral light absorption rate in the user.Temperature Sensor: In some embodiments, system 100 (e.g., sensors array 114 of mouthpiece 102) comprises at least one oral temperature sensors configured to continuously monitor oral temperature monitoring, which provides a close indication of core body temperature. These measurements can facilitate early fever detection, track circadian temperature rhythms, and assist in stress or fatigue estimation.Movement Sensors: In some embodiments, system 100 (e.g., sensors array 114 of mouthpiece 102) comprises at least one movement sensor configured to continuously track head and / or jaw movements of a user. Such movement sensor can measure the velocity and linear and / or angular acceleration of the user’s head and / or jaw in multiple axes. Movement sensors include accelerometers, gyroscopes, as well as magnetometers. One example of a movement sensor is an IMU — inertial measurement units, which detects motion and orientation over one or more axes. Theoutput of head and / or jaw movement sensors can be collected as time-series data of accelerations and rotations, which can be analyzed to recognize specific head and / or jaw movement patterns. These movement patterns can in turn be used for sleep patterns analysis; capture unusual movements that might signal neurological issues, and detect sleep bruxism episodes (unconscious teeth grinding or clenching).Sound sensors: In some embodiments, system 100 (e.g., sensors array 114 of mouthpiece 102) comprises at least one microphone configured to continuously monitor and analyze the user’s vocal patterns, wherein in vocal patterns may be used as a diagnostic tool and for disease and risk prediction.

[0129] In some embodiments, each sensor comprising sensors array 114 may be located on or with respect to mouthpiece 102, such that it is suitably or advantageously positioned in relation to the user’s oral cavity for optimal performance of its respective function. For example, at least one sensor comprising sensors array 114 may be located on or with respect to mouthpiece 102, such that it is at a specified position relative to a selected tissue surface within the user’s mouth, including, but not limited to, the hard palate, soft palate, uvula, inner cheeks, interior lips, medial and lateral surfaces of the gums, top and under surfaces of the tongue, and the floor of the mouth. In one example, at least one sensor comprising sensors array 114 may be located within an interior space defined by anterior light applicator 106 and / or lateral light applicators 109a, 109b, respectively. In another example, at least one sensor comprising sensors array 114 may be located fixedly or adjustably arranged on or attached to one or more external surfaces of mouthpiece 102.

[0130] In some embodiments, each sensor comprising sensors array 114 may be configured to continuously or periodically monitor and measure a respective value physiological, biochemical, and / or biomechanical value. In some embodiments, the output signal of each sensor comprising sensors array 114 may be a time-series of data representing a series of data points indexed, listed or graphed in time order. In some embodiments, sensors module 128 of control unit 122 is configured to receive the data collected via the plurality of sensors. In some embodiments, sensors module 128 of control unit 122 is configured to record and store the collected data, e.g., on storage device 124a. In some embodiments, at least part of the collected sensor data may be transmitted, e.g., via communication module136, to an external agent, such as a smartphone, a smartwatch, a tablet, a personal computer, and / or a remote server.

[0131] In some embodiments, control unit 122 may comprise an Al engine 132 configured to at least one of generate, train, validate, test and deploy one or more machine learning models configured to detect, identify, diagnose or predict a health condition in the user, based, at least in part, on the data collected via the plurality of sensors comprising sensors array 114.

[0132] In one example, Al engine 132 is configured to analyze the data collected via the plurality of sensors comprising sensors array 114, to perform one or more of the following:Detect patterns and trends in the sensors data.Identify anomalous patterns and trends in the sensors data, based on past patterns.Predict diseases, including predict risk or onset of diseases.Personalize light treatment patterns to the user, based on patterns and trends in the sensors data.

[0133] FIG. 4A is a flowchart of the functional steps is a method 400 for delivering light stimulus directed at tissue surfaces in the sublingual space for therapeutical purposes.

[0134] In some embodiments, method 400 is performed using exemplary system 100, described with reference to FIGS. 1A-1C, 2A-2D, and 3A-3C. The various steps of method 400 may either be performed in the order they are presented or in a different order (or even in parallel), as long as the order allows for a necessary input to a certain step to be obtained from an output of an earlier step. In addition, the steps of method 400 may be performed automatically and / or recursively (e.g., by system 100 of FIGS. 1A-1C), unless specifically stated otherwise.

[0135] In step 402, exemplary mouthpiece 102 may be received within a user’s mouth and positioned in a specific orientation relative to the oral cavity of the user, such that anterior light applicator 106 is positioned, at least with respect to a lower portion thereof, within an anterior area of the sublingual space behind the front lower teeth, opposite an anterior ventral surface of the user’s tongue and above the floor of the oral cavity and the lingual frenulum; and lateral light applicators 109a, 109b are positioned such that at least a lower portionthereof is located within the lingual side of the user's lower teeth and gums within the sublingual space.

[0136] In step 404, control unit 122 may be operated to select operational parameters of a light therapy session. In some embodiments, e.g., control unit 122 may be operated manually, e.g., by a user or a medical practitioner, using user interface 134. In other cases, control unit 122 may be programmed in advance to operate at a predetermined time or according to a predetermined schedule. In some embodiments, the operational of the light therapy session parameters may be set ad-hoc. For example, the user may select and adjust operational parameters for an ad-hoc therapy session, e.g., based on the therapy recommendations from a medical practitioner. In other cases, a therapy protocol may be selected from available protocol libraries, e.g., based on a therapy regimen devised for the user by a medical practitioner.

[0137] In step 406, control unit may start, pause, and / or resume the selected therapy session. During the therapy session, sensors module 128 of control unit 122 receives data collected via the plurality of sensors comprising sensors array 114 of mouthpiece 102. In some embodiments, sensors module 128 is configured to record and store the collected data, e.g., on storage device 124a. In some embodiments, at least part of the collected sensor data may be transmitted, e.g., via communication module 136, to an external agent, such as a smartphone, a smartwatch, a tablet, a personal computer, and / or a remote server.

[0138] In step 408, the therapy session continues according to its predetermined parameters until its scheduled end. Alternatively, the user may end the therapy session before its scheduled end by operating user interface 134.

[0139] FIG. 4B is a flowchart of the functional steps is a method 410 for real-time measuring of a user’s physiological, biochemical, and / or biomechanical data using a plurality of intraoral sensors, and for detecting and / or predicting a health condition in the user based, at least in part, on the measured data.

[0140] In some embodiments, method 410 is performed using exemplary system 100, described with reference to FIGS. 1A-1C, 2A-2D, and 3A-3C. The various steps of method 410 may either be performed in the order they are presented or in a different order (or even in parallel), as long as the order allows for a necessary input to a certain step to be obtainedfrom an output of an earlier step. In addition, the steps of method 410 may be performed automatically and / or recursively (e.g., by system 100 of FIGS. 1A-1C), unless specifically stated otherwise.

[0141] In step 412, exemplary mouthpiece 102 may be received within a user’s mouth and positioned in a specific orientation relative to the oral cavity of the user, and control unit 122 may be operated to select operational parameters of a light therapy session.

[0142] In step 414, control unit 122 may execute sensors module 128, wherein sensors module 128 is configured to operationally connect to and control sensors array 114 of mouthpiece 102. In some embodiments, sensors module 128 is configured to operationally control sensors array 114 to continuously or periodically measure a plurality of physiological, biochemical, and / or biomechanical signals from the user’s body, including signals associated with one or more of including, but not limited to, vital signs, respiratory cycle, blood oxygen level, oral light absorption rate, head motion, saliva chemistry, and / or vocal patterns.

[0143] FIGS. 4C-4D show exemplary sensor measurement data, according to some embodiments of the present disclosure. For example, FIG. 4C shows a time-series of light output measurements over a period of time. FIG. 4D shows a time-series of saliva impedance measurements over a period of time.

[0144] In step 416, control unit 122 may log and store the collected sensor measurements data, e.g., on storage device 124a.

[0145] In step 418, control unit 122 may execute Al engine 132 to detect or predict a health condition in the user, based on the sensor measurement data. In some embodiments, control unit 122 may execute Al engine 132 to perform at least one of the following tasks:Detect patterns and trends in the sensors data.Identify anomalous patterns and trends in the sensors data, based on past patterns.Predict diseases, including predict risk or onset of diseases.Personalize light treatment patterns to the user, based on patterns and trends in the sensors data.

[0146] Reference is now made to FIGS. 5A-5B which show a second variation of an exemplary mouthpiece 502 of the present disclosure. Mouthpiece 502 will be described with continued reference to exemplary system 100 for delivering light stimulus directed at tissue surfaces in the sublingual space for therapeutical purposes, as shown in FIGS. 1A-1C.

[0147] As can be seen in FIGS. 5A-5B, mouthpiece 502 may be configured to seated on a section comprising one or more teeth (e.g., one or more lower canines, premolars and / or molars) of the user’s lower dental arch, such that an anterior end 502a of mouthpiece 502 is facing in the anterior direction, and posterior end 502b is facing in the posterior direction.

[0148] In some embodiments, two mouthpieces 502 may be used, wherein each mouthpiece 502 may be seated on opposite lateral sides of the user’s lower dental arch as can be seen in FIG. 2B.

[0149] Mouthpiece 502 comprises a lingual-side flange or extension 506 extending laterally and downwardly towards the underside of the user’s tongue (not shown). The flange 506 comprises one or more light elements 512 configured to project light irradiation from the upper and / or lower surfaces of flange 506, so as to apply light stimulus to specific sites in the sublingual space of the user’s mouth, including the underside of the user’s tongue, the floor of the user’s mouth, and / or the medial surface of the lower jaw of the user.

[0150] In some embodiments, mouthpiece 502 comprises a connector 510 located about anterior end 502a of mouthpiece 502, for connecting cable 120 to control unit 122 of system 100.

[0151] Reference is made to FIGS. 6A-6H which show an exemplary mouthpiece 502 of the present disclosure in perspective exploded (FIG. 6A), back perspective (FIG. 6B), right front perspective (FIG. 6C), left front perspective (FIG. 6D), lingual side (FIG. 6E), buccal side (FIG. 6F), top (FIG. 6G), and bottom (FIG. 6H) views.

[0152] In some embodiments, mouthpiece 502 comprises an elongated body 504 having a substantially U-shaped cross section adapted to be seated on a section comprising one or more teeth of the user’s lower dental arch, e.g., one or more of the user’s lower canines, premolars and / or molars.

[0153] FIGS. 7A-7C show an exemplary elongated body 504 of the present disclosure in front perspective (FIG. 7A), back perspective (FIG. 7B), and side (FIG. 7C) views.

[0154] Elongated body 504 comprises a substantially flat top surface, and at least a first side-wall descending from the top surface. In some embodiments, the at least first side-wall 504a descends from the top surface on the lingual side. In some embodiments, the at least first side-wall 504b descends from the top surface on the buccal side. In some embodiments, elongated body 504 comprises a second side-wall descending from the top surface on an opposite side to the first side wall, such that if the first side wall descends on the lingual side 504a, the second side wall descends on the buccal side 504b, and vice-versa. In some embodiments, first and second side wall 504a, 504b are substantially parallel to one another. In some embodiments, the top surface and side walls 504a, 504b define a trough or through- channel 504c along a length dimension of elongated body 504, wherein channel 504c is configured to receive one or more teeth of the user’s lower dental arch, e.g., one or more of the user’s lower canines, premolars and / or molars, therein.

[0155] In some embodiments, the top surface and first and second side walls may have different thicknesses. In some embodiments, first and second side walls 504a, 504b may be of substantially equal length, width, and thickness. In some embodiments, first and second side walls 504a, 504b may be unequal in at least one of the length, width, or thickness dimensions. In some embodiments, the distance between the top surface and the lower reaches of first side wall 504a ranges from approximately 2 mm to approximately 10 mm, 3 mm to approximately 8 mm, or 4 mm to approximately 6 mm.

[0156] In some embodiments, elongated body 504 may be configured to be stably or snugly affixed to one or more teeth, e.g., through the compression force produced by and between first and second side walls 504a, 504b.

[0157] In some embodiments, elongated body 504 is generally formed as a relatively thin layer of material. The material may be substantially rigid to permit the channel 504c to engage the teeth to mechanically secure the elongated body 504 over at least a portion of the lower teeth of a user. Elongated body 504 may be integrally-formed as a single -piece from a single material. Alternatively, various portions of the elongated body 504 may be composed of one or more different materials, or one or more layers of materials. Thesematerials can include various forms of silicon; ethyl-vinyl acetate (EVA); thermoplastic polyolefin, various ethylene-based plasterers; various hydrocarbon resins (which are may be combined with EVA, thermoplastic polyolefin, or various ethylene-based elastomers), polycaprolactone (which may be combined with EVA), low-density polyethylene, high density poly-ethylene, polycarbonate and / or various polymers, laminates and other materials that will be recognized by those skilled in the art upon review of the present disclosure. In some embodiments, elongated body 504 may be produced in a variety of sizes to fit the oral anatomy and dimensions of different users. In some embodiments, elongated body 504 may be constructed of a heat-formable polymer that softens when heated to allow the elongated body to be customized to the user's mouth.

[0158] With reference back to FIGS. 6A-6H, mouthpiece 502 comprises a lingual-side flange or extension 506 extending laterally and downwardly towards the underside of the user’s tongue.

[0159] In some embodiments, flange 506 may be integrally-formed as a single -piece with elongated body 504. In other embodiments, flange 506 may be separately-formed and attached to, e.g., the top surface of elongated body 504, so as to extend laterally and downwardly on the lingual side towards the underside of the user’s tongue, when device 502 is in use.

[0160] In some embodiments, flange 506 may be positioned in relation to elongated body 504 such that, when elongated body 504 is affixed to one or more teeth within of the user’s lower dental arch, flange 506 is positioned to deliver light irradiation or stimulus to desirable treatment sites within the sublingual space, such as particular blood vessels and nerves, e.g., the lingual artery and nerve, the hypoglossal nerve, and / or the glossopharyngeal nerve.

[0161] FIGS. 8A-8C show an exemplary separately-formed flange 506 of the present disclosure in front perspective (FIG. 8A), side (FIG. 8B), and top perspective (FIG. 8C) views.

[0162] Exemplary flange 506 shown in FIGS. 8A-8C comprises a flange portion 506a and a mounting surface 506b configured for attaching at the top surface of elongated body 504, e.g., by mechanical fastening means or systems, by fusing, by gluing, or by bonding mounting surface 504b with the top surface of elongated body 504. In some embodiments,flange portion 506a may define a generally planar surface. However, in other embodiments, flange portion 506a may have a curvature along a longitudinal and / or transverse axis thereof, or may comprise one or more angular planes or surfaces oriented in various directions.

[0163] In some embodiments, flange portion 506a comprises an array of light elements 512 arranged in a predetermined pattern thereon. In some embodiments, flange portion 506a comprises, e.g., 1, 2, 3, 4, 5, 6, 8, 10, 12, or more light elements 512 arranged thereon.

[0164] In some embodiments, light elements 512 may comprise any suitable combination of light elements configured to emit light in a specific wavelength or in a specific band of wavelengths. Accordingly, in some embodiments, light elements 512 may comprise any suitable combination of one or more light-emitting diodes (LEDs) and / or laser diodes.

[0165] In some embodiments, one or more of the light elements 512 may be configured to emit light in any one of the wavelengths 405 nm, 436 nm, 486 nm, 536 nm, 588 nm, 635nm, 656 nm, 660 nm and 860 nm. In some embodiments, each light element 512 may be configured to emit light having a wavelength within the red to infra-red range. In some embodiments, each light element 512 may be configured to emit light at a wavelength between 600 and 1200 nm, between 600 and 700 nm, between 700 and 800 nm, between 800 and 820 nm, between 820 and 850 nm, between 800 and 850 nm, between 850 and 900 nm, between 900 and 1000 nm, between 1000 and 1100 nm, between 1100 and 1200 nm, between 1200 and 1300 nm, between 1300 and 1400 nm, between 1400 and 1500 nm, including any range therebetween. In some embodiments, the wavelength range may be, e.g., between 780-1400 nm, 1400-3000 nm, 1000-3000 nm, 800-2500 nm, 2.5-50 um, and / or 50- 2000 um.

[0166] In some embodiments, light elements 512 are arranged on flange 506 in a form of a light element 512 array. In some embodiments, the light element 512 array is in a form of a single row, or a plurality of rows, which may be parallel. In some embodiments, the light element 512 array is linear or curved. In some embodiments, the light elements 512 are arranged on flange 506 in a form of two or more parallel rows, so as to form parallel light element arrays. In some embodiments, light elements 512 are arrayed in one or more of a circular array, an oval array, a rectangular array, a triangular array, a polygonal array, a columnar array, and / or a horseshoe array. In some embodiments, the light element 512 arraydefines an axis (e.g. a longitudinal axis) of flange 506. In some embodiments, the light elements 512 are arranged along an axis of flange 506.

[0167] In some embodiments, light elements 512 may be fixedly embedded in flange 506. In some embodiments, light elements 512 may be adjustably coupled to flange 506, wherein, e.g., a projections orientation of each light element 512 may be adjusted in relation to a plane of flange 506, so as to allow mouthpiece 502 to be customized to the oral cavity anatomy of a particular user.

[0018] In some embodiments, a projection orientation of one or more of the light elements 512 relative to the sublingual space is adjustable by varying a dimension or shape of flange 506, so as to allow mouthpiece 502 to be customized to the oral cavity anatomy of a particular user. In some embodiments, a projection orientation of one or more of the light elements 512 relative to the sublingual space is adjustable by varying a shape and / or curvature of flange 506, (e.g., from a planar flange to a curved flange) along a longitudinal axis and / or a transverse axis of flange 506.

[0169] In some embodiments, each light element 512 may be oriented so as to project a light beam to irradiate a specific sublingual space neural site. In some embodiments, two or more light elements 512 may be oriented so as to jointly irradiate a specific sublingual space neural site. In some embodiments, at least one of the light elements 512 may be oriented so as to project a light beam extending from a top plane of flange 506, and at least one light element 512 may be oriented so as to project a light beam extending from a bottom plane of flange 506.

[0170] In some embodiments, a plurality of light elements 512 is configured to emit a plurality of light beams forming a single cone beam. In some embodiments, the cone beam has a convergence point, e.g., a vertex, which may define a treatment site in the sublingual space. In some embodiments, the plurality of light beams form a beam cone having a distal and / or forward region forming a plane which defines a treatment site region in the sublingual space.

[0171] In the description and claims, each of the terms “substantially,” “essentially,” and forms thereof, when describing a numerical value, means up to a 20% deviation (namely,±20%) from that value. Similarly, when such a term describes a numerical range, it means up to a 20% broader range - 10% over that explicit range and 10% below it).

[0172] In the description, any given numerical range should be considered to have specifically disclosed all the possible subranges as well as individual numerical values within that range, such that each such subrange and individual numerical value constitutes an embodiment of the present disclosure. This applies regardless of the breadth of the range. For example, description of a range of integers from 1 to 6 should be considered to have specifically disclosed subranges such as from 1 to 3, from 1 to 4, from 1 to 5, from 2 to 4, from 2 to 6, from 3 to 6, etc., as well as individual numbers within that range, for example, 1, 4, and 6. Similarly, description of a range of fractions, for example from 0.6 to 1.1, should be considered to have specifically disclosed subranges such as from 0.6 to 0.9, from 0.7 to 1.1, from 0.9 to 1, from 0.8 to 0.9, from 0.6 to 1.1, from 1 to 1.1 etc., as well as individual numbers within that range, for example 0.7, 1, and 1.1.

[0173] The descriptions of the various embodiments of the present invention have been presented for purposes of illustration, but are not intended to be exhaustive or limited to the explicit descriptions. Many modifications and variations will be apparent to those of ordinary skill in the art without departing from the scope and spirit of the described embodiments. The terminology used herein was chosen to best explain the principles of the embodiments, the practical application or technical improvement over technologies found in the marketplace, or to enable others of ordinary skill in the art to understand the embodiments disclosed herein.

[0174] In the description and claims of the application, each of the words “comprise,” “include,” and “have,” as well as forms thereof, are not necessarily limited to members in a list with which the words may be associated.

[0175] Where there are inconsistencies between the description and any document incorporated by reference or otherwise relied upon, it is intended that the present description controls.

Claims

CLAIMSWhat is claimed is:

1. A sublingual light therapy system comprising: a control unit configured to generate control signals which determine operational parameters of said light therapy; and a mouthpiece operationally connected to said control unit and configured to be removably received at a specific position within the sublingual space of an oral cavity of a user, wherein said mouthpiece comprises two lateral light applicators configured to be located within opposing lingual sides of the lower teeth and gums of said oral cavity, and wherein each of said lateral light applicators comprises at least one light element configured to project light irradiation toward the ventral surfaces of the tongue, the lingual frenulum, and the floor of the mouth.

2. The system of claim 1, wherein said mouthpiece further comprises an anterior light applicator configured to be located within an anterior area of the sublingual space of said oral cavity, and wherein said anterior light applicator comprises at least one light element configured to project light irradiation from toward the ventral surfaces of the tongue, the lingual frenulum, and the floor of the mouth.

3. The system of any one of claims 1 or 2, wherein said mouthpiece is formed as a U- shaped member comprising an anterior portion comprising said anterior light applicator, and two lateral arms extending from opposing sides of said anterior portion in the posterior direction, wherein said two lateral arms comprise each a respective one of said lateral light applicators.

4. The system of any one of claims 1-3, wherein said specific position is along a lingual side of the lower teeth and gums of said oral cavity.

5. The system of any one of claims 1-4, wherein said at least one light element is selected from the group consisting of: light-emitting diode (LED), and laser diode.

6. The system of any one of claims 1-5, wherein said at least one light element is a light element array comprising between 2-12 of said light elements.

7. The system of any one of claims 1-6, wherein each of said one or more light elements is configured to emit light in one of the following wavelengths: 405 nm, 436 nm, 486 nm, 536 nm, 588 nm, 635nm, 656 nm, 660 nm, and 860 nm.

8. The system of any one of claims 1-7, wherein said control unit comprises one or more of the following components: a microcontroller, a storage device, a light signal generator, a sensors module, a power source, and a communication module.

9. The system of any one of claims 1-7, wherein said operational parameters of said light therapy are selected from the group consisting of: total duration of said light irradiation, wavelengths of said light irradiation, intensity of said light irradiation, modulation patterns of said light irradiation, and total energy dose of said light irradiation.

10. The system of any one of claims 1-9, wherein said mouthpiece comprises at least one sensor configured to measure at least one physiological, biochemical, and / or biomechanical parameters of said user, selected from the group consisting of: heart rate, heart rhythm, blood oxygen saturation, blood pressure, oral tissue light absorption rate, respiratory cycle, head and jaw motion, saliva chemistry, saliva impedance, and vocal patterns.

11. The system of any one of claims 1-10, wherein said mouthpiece is operationally connected to said control unit via a wireless connection or via a cable connection.

12. A method for using a sublingual light therapy system comprising: providing a system comprising: a control unit configured to generate control signals which determine operational parameters of said light therapy; and a mouthpiece operationally connected to said control unit and configured to be removably received at a specific position within the sublingual space of an oral cavity of a user,wherein said mouthpiece comprises two lateral light applicators configured to be located within opposing lingual sides of the lower teeth and gums of said oral cavity, and wherein each of said lateral light applicators comprises at least one light element configured to project light irradiation toward the ventral surfaces of the tongue, the lingual frenulum, and the floor of the mouth; positioning said mouthpiece in said specific position within said oral cavity; and operating said control unit to select operational parameters of said light therapy.

13. The method of claim 12, wherein said mouthpiece further comprises an anterior light applicator configured to be located within an anterior area of the sublingual space of said oral cavity, and wherein said anterior light applicator comprises at least one light element configured to project light irradiation from toward the ventral surfaces of the tongue, the lingual frenulum, and the floor of the mouth.

14. The method of any one of claims 12 or 13, wherein said mouthpiece is formed as a U-shaped member comprising an anterior portion comprising said anterior light applicator, and two lateral arms extending from opposing sides of said anterior portion in the posterior direction, wherein said two lateral arms comprise each a respective one of said lateral light applicators.

15. The method of any one of claims 12-14, wherein said specific position is along a lingual side of the lower teeth and gums of said oral cavity.

16. The method of any one of claims 12-15, wherein said at least one light element is selected from the group consisting of: light-emitting diode (LED), and laser diode.

17. The method of any one of claims 12-16, wherein said at least one light element is a light element array comprising between 2-12 of said light elements.

18. The method of any one of claims 12-17, wherein each of said one or more light elements is configured to emit light in one of the following wavelengths: 405 nm, 436 nm, 486 nm, 536 nm, 588 nm, 635nm, 656 nm, 660 nm, and 860 nm.

19. The method of any one of claims 12-18, wherein said control unit comprises one or more of the following components: a microcontroller, a storage device, a light signal generator, a sensors module, a power source, and a communication module.

20. The method of any one of claims 12-19, wherein said operational parameters of said light therapy are selected from the group consisting of: total duration of said light irradiation, wavelengths of said light irradiation, intensity of said light irradiation, modulation patterns of said light irradiation, and total energy dose of said light irradiation.

21. The method of any one of claims 12-20, wherein said mouthpiece comprises at least one sensor configured to measure at least one physiological, biochemical, and / or biomechanical parameters of said user, selected from the group consisting of: heart rate, heart rhythm, blood oxygen saturation, blood pressure, oral tissue light absorption rate, respiratory cycle, head and jaw motion, saliva chemistry, saliva impedance, and vocal patterns.

22. The method of any one of claims 12-21, wherein said mouthpiece is operationally connected to said control unit via a wireless connection or via a cable connection.

23. A sublingual light therapy device comprising: a mouthpiece configured to be removably received at a specific position within the sublingual space of an oral cavity of a user, wherein said mouthpiece comprises two lateral light applicators configured to be located within opposing lingual sides of the lower teeth and gums of said oral cavity, and wherein each of said lateral light applicators comprises at least one light element configured to project light irradiation toward the ventral surfaces of the tongue, the lingual frenulum, and the floor of the mouth.

24. The device of claim 23, wherein said mouthpiece further comprises an anterior light applicator configured to be located within an anterior area of the sublingual space of said oral cavity, and wherein said anterior light applicator comprises at least one light element configured to project light irradiation from toward the ventral surfaces of the tongue, the lingual frenulum, and the floor of the mouth.

25. The device of any one of claims 23 or 24, wherein said mouthpiece is formed as a U-shaped member comprising an anterior portion comprising said anterior light applicator, and two lateral arms extending from opposing sides of said anterior portion in the posterior direction, wherein said two lateral arms comprise each a respective one of said lateral light applicators.

26. The device of any one of claims 23-25, wherein said specific position is along a lingual side of the lower teeth and gums of said oral cavity.

27. The device of any one of claims 23-26, wherein said at least one light element is selected from the group consisting of: light-emitting diode (LED), and laser diode.

28. The device of any one of claims 23-27, wherein said at least one light element is a light element array comprising between 2-12 of said light elements.

29. The device of any one of claims 23-28, wherein each of said one or more light elements is configured to emit light in one of the following wavelengths: 405 nm, 436 nm, 486 nm, 536 nm, 588 nm, 635nm, 656 nm, 660 nm, and 860 nm.

30. The device of any one of claims 23-29, wherein said mouthpiece is operationally connected to a control unit via a wireless connection or via a cable connection.

31. The device of claim 30, wherein control unit comprises one or more of the following components: a microcontroller, a storage device, a light signal generator, a sensors module, a power source, and a communication module.

32. The device of any one of claims 22-30, wherein said operational parameters of said light therapy are selected from the group consisting of: total duration of said light irradiation, wavelengths of said light irradiation, intensity of said light irradiation, modulation patterns of said light irradiation, and total energy dose of said light irradiation.

33. The device of any one of claims 23-31, wherein said mouthpiece comprises at least one sensor configured to measure at least one physiological, biochemical, and / or biomechanical parameters of said user, selected from the group consisting of: heart rate, heart rhythm, blood oxygen saturation, blood pressure, oral tissue light absorption rate,respiratory cycle, head and jaw motion, saliva chemistry, saliva impedance, and vocal patterns.

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