TECHNOLOGICAL FIELD AND BACKGROUND

The present invention is in the field of medical devices, and relates to a medical device for stimulating eye activity of an individual.

Blinking and tear production are main mechanisms that protect the eye. Blinking serves as a mechanical shield for the cornea, but also disperses the tear film in a thin and even layer, uniformly covering the entire surface of the eye. During a short period lasting between 30-100 milliseconds the innermost circular muscle fibers of the orbicularis muscle constrict (tarsal). Most of the vertical movement is performed by the upper eyelid while the lower eyelid does most of the horizontal movement.

Frequent blinking and tear production are necessary to maintain a healthy eye surface and normal vision. For example, an average person blinks over 15,000 times each day autonomously and unconsciously. Blink rate is controlled by different sensory and psychomotor parts of the brain and is executed by the facial nerve and the orbicularis muscle around the eye. A decrease in the blink rate can impair the quality of vision and even endanger the eye itself.

Blink and dry eye disorders are common in various neurological diseases but are even more common among normal people utilizing their eyes under un-neutral conditions such as extended periods of computer screen time.

People who suffer from dry eye issues, include, for example:

1. Unconscious patients in intensive care units and rehabilitation wards that do not close their eyes spontaneously.

2. Patients with acute or chronic paralysis of the facial nerve on one side (say people with Bell’s Palsy) who do not blink because of muscle paralysis. In these patients, optimal blink restoration also involves synchronization of the blink to the healthy eye.

3. Patients with Parkinson's disease with blinking disorder due to a general decrease in motility and facial mimics. 4. The largest group of all, includes people who spend many hours in front of computer screens and cell phones.

GENERAL DESCRIPTION

There is a need in the art for a novel medical device for monitoring, controlling, and affecting such eye activity as blinking and/or tear production.

The present invention provides a novel approach for configuration and operation of such medical device capable of artificially stimulating eye activities/functions. More specifically, the invention provides a stimulator which can be incorporated in a wearable or attachable appliance to be attached to individual's face (i.e., being incorporated within the frame of glasses or a label/pad) or may be autonomous device configured to attachable to a wearable appliance, such as glasses. The stimulator of the present invention is adapted to be controllably operable to apply a stimulating effect on one or more nerves in the facial region of the user, to thereby effect/induce at least one predetermined activity of an eye of the user. Such eye activity includes blinking and/or tears production.

Considering blinking function/activity, the stimulating effect may be associated with neuro-muscular electrostimulation (NMES) of one or more nerves in a selected region in the vicinity of the eye as to cause contraction of the periocular muscle(s) resulting in eye blinking. The device of the present invention is capable of stimulating blinking function causing full blinking effect (via fully closure of the eye).

The technique of the present invention is aimed at providing personalized solution for stimulating the eye activity, in particular blinking function of individual's eyes and/or tears production. The inventors have found that a facial region, which includes nerves that are responsible for the specific eye activity and thus need to be stimulated, has an individual- specific sensitivity map. This results in that application of a stimulating signal / field to some location(s) within said region, while providing desired eye activity, might cause pain or discomfort, and application of said stimulating signal/field to some other location(s) in the same region may be of the sane effectivity with respect to the desired eye activity while eliminating or at least significantly minimizing pain and/or discomfort.

Arrangement/distribution of such different-sensitivity locations (i.e. sensitivity map) varies from individual to individual. On the other hand, it is desirable for a medical device to be suitable for use by various individuals. The present invention provides for adjusting the personalized operation of the stimulator, whose configuration is generally suitable for use by any individual. Moreover, the invention provides for adjusting the stimulator operation for selectively implement stimulation sessions inducing different stimulating effects, each performed in the individual-specific mode.

Further, it should be understood that the individual- specific sensitivity map might be different for the facial regions of interests associated with left and right eyes of said individual. The stimulator of the present invention enables its proper operation based on the sensitivity maps in relation to both such regions interest.

According to the personalized approach of the present invention, the stimulator includes one or two stimulating arrangements for stimulating eye function(s) of one or both of individual's eyes. The stimulating arrangement includes an array of individually operable stimulating elements arranged along an interface region corresponding to a region of interest on individual's face. The stimulator further includes a controller which is adapted (preprogrammed) to activate a selected (individual-specific) one or more (sub array) of the stimulating elements of each stimulating arrangement to apply the predetermined stimulating effect at selected one or more locations of said element(s), while avoiding application of said stimulating effect outside the selected location(s). The selected one or more locations on individual's facial region, and accordingly the selected one or more stimulating elements within the interface region, are defined in accordance with previously obtained (in a calibration stage) predetermined data indicative of facial nerve's sensitivity maps of the individual.

Thus, according to one broad aspect of the invention, it provides a device for stimulating one or more eye functions of at least one of individual's eyes. The device comprises a stimulator which is configured to be incorporated in or mountable on an appliance attachable to individual's face and comprises a respective at least one stimulator arrangement, the stimulator arrangement defining an interface region for covering a region of interest on the individual's face in a vicinity of the respective individual's eyes, said stimulator arrangement being adapted to be controllably operable by a local controller of the stimulator to apply a stimulating effect on one or more nerves in the region of interest to thereby affect at least one predetermined eye function. The stimulator arrangement comprises an array of stimulating elements, each stimulating element being individually operable by said local controller to generate a stimulating signal at a respective location of said stimulating element within said interface region. The local controller is configured and operable to activate a predetermined individual- specific sub array of the stimulating elements from said array during a stimulation session, wherein locations of the stimulating elements of the sub-array within the interface region enable a desired spatial pattern of the stimulating effect to be applied while avoiding applications of said stimulating effect outside said locations within the interface region.

In some embodiments, the local controller is configured and operable to utilize predetermined data indicative of an individual-specific facial nerve's sensitivity map of the individual, predetermined at a calibration stage performed once for said individual, to define the selected sub-array of the stimulating elements for use in stimulation sessions.

In some embodiments, the individual- specific facial nerve's sensitivity map is stored in a memory of an electronic circuitry of the stimulator. Alternatively or additionally data indicative of the individual-specific facial nerve’s sensitivity map is stored in a memory of a personal communication device of the individual being in data communication with the controller of the stimulator.

The stimulating arrangement may be of any type capable of generating stimulating signals of various types, such as electrical signals, electromagnetic radiation, ultrasonic radiation.

In some embodiments, the stimulator arrangement is configured and operable to generate electric stimulating signals. For example, the stimulator arrangement comprises an electrodes arrangement configured and operable to generate the stimulating effect associated with neuro-muscular electrostimulation (NMES) of said one or more nerves.

In some embodiments, the stimulator arrangement comprises first and second electrodes, wherein the first electrode is configured to be attached to and extend along said interface region and is formed by said array of first electrode elements, each being individually operable by the controller to form an electrode pair with the second electrode to apply NMES signal to a respective location of the first electrode element within said interface region. The local controller is configured and operable to activate a selected sub array of said array of the first electrode elements whose locations define a desired spatial pattern of NMES signals to be applied while avoiding applications of NMES signals outside said locations within the interface region, resulting in safety and optimal nerves' stimulation and muscle contraction. In some embodiments, the local controller is configured and operable to utilize operational data indicative of a predetermined time pattern of activation of the selected sub-array of the stimulating elements.

In some embodiments, the local controller is configured and operable to communicate with a sensing system providing sensing data indicative of the individual eyes' condition. The sensing system may be integral with the appliance carrying the stimulator. The sensing system may be an imaging system.

The local controller may be configured and operable to communicate with the sensing system and be responsive to sensing data originated in the sensing system and being indicative of the individual eyes' condition, to selectively activate said selected sub array of the electrode elements.

The local controller may be configured and operable to affect stimulation of the eye activity via the selected sub-array of the stimulating elements upon identifying, from the sensing data, the individual eye's condition corresponding to absence of said eye activity during a predetermined time interval.

The appliance carrying the stimulator may comprise glasses wearable by individual. Such glasses are one of the following types: vision correcting glasses, sunglasses, vision correcting sunglasses, virtual/augmented-reality glasses.

In some embodiments, the first electrode may be integral with a nose pad of the glasses, and the second electrode may be located in temples of the glasses.

In some embodiments, the medical device (stimulator) is configured to be mounted on the glasses.

In some embodiments, the appliance carrying the stimulator is a label.

The invention, in its another broad aspect, provides glasses wearable by an individual, and comprising the above-described medical device of the present invention.

The invention, in its yet further aspect, provides an eye function stimulation system comprising the above-described medical device, and at least one additional stimulator of a different type.

Such additional stimulator may or may not be integral with the appliance carrying the medical device. The additional stimulator may be is configured and operable to be responsive to sensing data indicative of individual eyes' condition and generate a stimulation effect to notify the individual that the eye function is to be initiated to thereby induce voluntary conscious eye function. To this end, the additional stimulator may include a physical assembly adapted to generate the stimulation effect via a physical contact with individual's body (e.g. a predetermined contact application pattern). Alternatively or additionally, the additional stimulator may include a computerized utility installed in individual's personal electronic device and configured and operable to generate, in response to the sensing data, the stimulation effect embedded in displayed data exposed to individual's eyes to thereby induce voluntary conscious eye function. The sensing system may be carried by the individual's personal electronic device to which user's eyes are exposed.

BRIEF DESCRIPTION OF THE DRAWINGS In order to better understand the subject matter that is disclosed herein and to exemplify how it may be carried out in practice, embodiments will now be described, by way of non-limiting example only, with reference to the accompanying drawings, in which:

Fig. 1 is a block diagram exemplifying an eye function stimulation device of the present invention;

Fig. 2 schematically illustrates an exemplary stimulator of the present invention incorporated in a label;

Figs. 3A to 3C exemplify the configuration of the functional parts of the device of the present invention with respect to a nerve circuitry in the facial region of an individual;

Figs. 4A to 4F exemplify the device of the present invention configured for integration within or mounting on individual's glasses;

Fig. 5 exemplifies configuration and operation of a calibration system/technique suitable to be used with the present invention; and Figs. 6A to 6C and 7A-7B exemplify different stimulation patterns and their effects selected in accordance with sensitivity map data of the specific individual and the eye function to be stimulated. DETAILED DESCRIPTION OF EMBODIMENTS

Reference is made to Fig. 1 illustrating, by way of a block diagram, a medical device 100 of the present invention configured and operable to artificially stimulate one or more eye function/activities of at least one eye of an individual, in particular blinking and/or tears production activities.

The device 100 includes a stimulator 102 which is configured to be incorporated in or mountable on an appliance 105 of the type attachable to / engageable with a region of interest ROI on the individual's face. The region of interest is a region aligned with a nerve circuitry responsible for the desired eye function(s), as will be described more specifically further below.

It should be understood that, in most cases, the same eye activity is to be induced at both eyes of the individual, while it may be the case that only one eye suffers from a specific disorder which is to be treated, or both eyes suffer from the same disorder bur at different extents. Thus, generally, the stimulator of the present invention can be configured for one eye treatment only. For example, the appliance 105 may be a label whose side defining the interface region can be glued along the facial region of interest in vicinity of the individual's eye.

However, since the medical device of the present invention is, on the one hand, configured to be used by any individual, while on the other hand is configured to perform personalized (individual- specific) stimulation of the eye function(s), the stimulator may be configured to be integrated in or mountable on the appliance intended to both eyes of the individual. Such appliance carrying the stimulator may be a part of any standard glasses wearable by individual. In this connection, it should be understood that standard glasses / spectacles that can serve the appliance for integration therein or mounting thereon the stimulator (medical device) of the present invention, may be typical vision correcting glasses, or regular or vision correcting sunglasses, or virtual/augmented-reality glasses.

As will be exemplified further below, the stimulator may be incorporated in the nose pads of glasses (or generally in one of the nose pads) which typically contacts with the individual's face; or in some embodiments, some of the functional elements of the stimulator are located in the nose pad(s) of glasses, while some other functional elements of the stimulator are integral with temple(s) of said glasses.

The stimulator 102 includes at least one stimulator arrangement 110 associated with a respective at least one eye of the individual for stimulating eye function(s) of said eye. For simplicity, the figure illustrates only one stimulator arrangement, but it should be understood that when stimulating eye function(s) of both eyes is considered (which is the most practical case), two such stimulator arrangements 110 are provided in association with two respective, substantially symmetric, regions of interest on the individual's face.

Also, the stimulator 102 includes a controller 108 which operates the stimulator arrangement to apply the desired stimulating effect on one or more of the relevant nerves in the facial region of interest, and by this effect at least one predetermined activity of the individual's eye (blinking and/or tears production). According to the invention, the stimulator arrangement 110 includes an array (matrix) of multiple stimulating elements, generally at SE, arranged in a spaced-apart relationship along an interface region IR which is configured to substantially match the region of interest ROI.

As shown in the specific not-limiting example of Fig. 1, the stimulating elements are arranged in a spaced-apart relationship in multiple rows (number M such rows), which include respective pluralities of spaced-apart stimulating elements (of the same or different numbers). It should be understood that, generally, the number and arrangement of the multiple stimulating elements SE depends inter alia on the geometry (dimensions and shape) of the interface region IR of the appliance, which in turn depends on that of the region of interest ROI.

Each stimulating element SE interfaces with (contacts) a respective location within the facial region of interest ROI covered by the stimulator arrangement 110 and is thus aligned with a corresponding location of the nerve circuitry. Each stimulating element SE has its respective identification parameter/index and its location within the interface region IR. Each stimulating element SE is individually operable by the controller 108, via an actuator circuitry 112, to generate the stimulating effect at the respective location of the region of interest. The actuator circuitry 112 may be part of the stimulator arrangement, or may be part of the controller 108, or the hardware/software utilities of the actuator circuitry may be distributed between the stimulator arrangement and the controller. Considering a pair of stimulator arrangements in association with the individual's eyes, the same controller 108 can be used to properly apply personalized (individual- specific and possibly also eye- specific) operation of each of the stimulator arrangements.

The controller 108 can thus activate a selected one or more of the stimulating elements to be involved in the stimulation session. In the description below such selected one or more stimulating elements are referred to as a sub-array of the stimulator arrangement 110. Generally, however, it might be the case that activating a single stimulating element is sufficient to achieve the desired stimulating effect of the eye.

According to the invention, the selected stimulating elements (selected sub-array) are elements located at selected locations of the interface region IR and thus interfacing / aligned with corresponding selected locations of the region of interest ROI, such that they provide a desired spatial pattern (i.e. fine tuning) of the stimulating effect only at the selected locations, while avoiding application of said stimulating effect outside these locations within the region of interest. To this end, the controller 108 operates to activate the selected stimulating elements in accordance with data indicative of an individual- specific (individual characteristic), and possibly also eye-specific, facial nerve's sensitivity map which is previously created and stored during a calibration stage performed by a calibration system 120.

Sensitivity map data SMD may be entered into an electronic circuit 107 of the stimulator via input utility 104 and stored in a memory 106 of the electronic circuit 107. Alternatively, or additionally, the sensitivity map data SMD may be stored in a memory of individual's personal communication device such as his/her smartphone (as shown in the figure). As will be described further below, the individual's personal communication device may be configured (i.e. installed with a dedicated software application) to perform the calibration stage to create the sensitivity map data for each eye of the individual. It should be noted that, generally, the sensitivity map indicative of the selected sub-array of the stimulating elements may be different for left and right eyes of the same individual. This is properly inspected and defined at the calibration stage. Thus, the sensitivity map data SMD is obtained by the calibration system 120 during the calibration stage which can be performed once to generate the sensitivity map data for each eye and this data is properly stored in the memory 106 of the medical device 100 or in the external device (e.g. smartphone) which operates the medical device 100. The stage of creation of the sensitivity map data will be described more specifically further below. This sensitivity map data SMD is indicative of the selected spatial pattern (sub-array) of the stimulating elements whose locations are aligned with locations within the nerve circuitry which, when activated induce the stimulating effect while with minimal pain / discomfort for the specific individual. The sensitivity map data SMD may also include data indicative of operational parameters of the selected stimulating elements in said sub-array.

The application of the stimulating effect via activation of the selected group / sub- array of stimulating elements may be performed in accordance with a predefined time pattern of activating and operating the selected stimulating elements, previously defined and stored as part of reference/calibradon data to be used by the controller. Alternatively or additionally, activation of the selected group / sub-array of stimulating elements may be performed per demand based on analysis of sensing data. Hence, as exemplified in the figure, in some embodiments, the medical device 100 may also be associated with a sensing system 122, which may or may not be part of the appliance 105. The sensing system 122 is adapted to monitor the individual eyes' condition and generate corresponding sensing data to enable, upon identifying that some critical time has passed without blinking and/or tears production, generation of a control signal to activate the stimulator operation.

Typically, although not specifically shown in the figure, such sensing system 122 includes: an optical unit either configured as a camera which produces image data or a light source and an optical detector to detects light reflection of illumination from the eye. Suitable analyzer (software utility) is thus also provided (being a part of the sensing system 122 or of the controller 108, or distributed software implemented by the sensing system and the controller) which analyzes the image data or the detected reflection data to determine duration of the open eye and/or dry condition of the individual ^' s eyes.

It should be noted that the principles of the present invention can be used with the stimulating arrangement of any known suitable type, i.e. generating stimulating signals of any type, such as electrical signals, electromagnetic radiation, ultrasonic radiation. More specifically, the present invention is useful for stimulating eye activities via electrical stimulation and is therefore described below with respect to this specific application, where the stimulating elements are electrode elements. However, it should be understood that the invention is not limited to this specific implementation.

Thus, in some embodiments, the stimulator arrangement 110 is configured as an electrodes' arrangement, including the matrix of first electrodes (e.g. anodes) operable as stimulating elements, each being in electrical connection with a second electrode (cathode) to form cathode-anode pair. The second electrode may be common for all the first electrodes, in which case the activation of the selected pairs is implemented via the selected first electrodes.

Fig. 2 schematically illustrates an appliance (e.g. label) 106 incorporating: the stimulator arrangement 110 including the array of first electrodes, generally at 116, all connected to the common second element 118; and the electronic circuit 107 (chip) configured generally similar to that described above with reference to Fig. 1. As indicated above, and will be exemplified further below, the electronic circuit, as well as the second electrode, may be located in a different part of the device while being properly connected or connectable to the first electrodes.

Considering stimulation of such eye functions as blinking and/or tears production, the stimulator 102 may be configured to implement such stimulating effect as NeuroMuscular Electrostimulation (NMES) of the facial nerve circuitry to contract the Periocular muscles (eyelid closure muscles). To this end, the stimulator is operable to apply modulated electrical pulsed signals, via selected locations of the interface region matching corresponding locations of the region of interest.

In this connection, reference is made to Figs. 3A-3C. The present invention pertains to positioning the interface region for transcutaneous electrical stimulation enabling a painless and effective contraction of the orbicularis oculi muscle, as shown in Fig. 3A. The appliance is configured to be positioned such that the interface region of the stimulator is aligned with and allows stimulation of the region of interest which mainly includes the terminal nerve fibers of the buccal (Deep and Superficial) branch of the facial nerve circuitry and possibly also intermingling fibers from the zygomatic or temporal branches (Fig. 3B).

Fig. 3C schematically illustrates an exemplary relative accommodation of the arrangement of first electrodes (anodes - stimulating elements) 116 defining the interface region of the stimulator and the second associated electrode (cathode) 118. It should be noted that the stimulator is preferably configured to enable orientation of the interface region IR of the stimulator medially to an imaginary line crossing the center of the pupil perpendicularly to the pupil plane. This is contrary to the conventional approach in the stimulation devices of the kind specified (i.e. blink stimulators), according to which a stimulator (a continuous elongated electrode) is applied to the facial region such that it is oriented laterally to the perpendicular line crossing the pupil, which results in the stimulation of more proximal branches of the temporal and zygomatic branches, rather than buccal branches.

As for the second electrode (cathode) 118, it may be positioned behind the ear as exemplified in the figure. It should, however, be understood that the second electrode can be placed almost anywhere on the body, including the fingertips. The ear was chosen because it works well with the configuration of glasses.

The operational parameters of the stimulation arrangement may be similar to those used in any known suitable device of the kind specified. However, according to the invention, the stimulation arrangement is configured as described above including an array / matrix of individually operable stimulating elements, enabling to apply the relevant operational parameters to the individual- specific (and possibly also eye-specific) sub-array of the stimulating elements selected in accordance with the individual’s sensitivity map.

Considering specific not limiting example of the stimulation arrangement configured to generate electric signals to effect Electrostimulation (NMES) of the facial nerve circuitry to contract the Periocular muscles (eyelid closure muscles), the selected electrode elements can be operated/activated by the following operational parameters / conditions: pulse train (about 20 records) of biphasic square wave pulses (at 250 Hz with 50% peak percentage from the duty cycle); and stimulation waveform parameters including: voltage of about 20-30 volts (this parameters typically varies from individual to individual), electric current in a range of 4-20 mA. Typically, using electrode gel can improve the conductivity and reduce the required voltage by about 30%. The inventors have found that increasing the peak time from the cycle provides a similar effect to increasing the tension; increasing the number of peaks from 20 to 50, while having no significant effect on closing the eye, affects the pain level (a little more painful).

As described, the stimulator itself can be integrated in a label that can be glued to the face region which is engageable by a respective portion of standard glasses. The glasses can thus assist in keeping the label in place and adhering the interface region to the facial region of interest.

It is a practical and simple solution to implement the stimulator of the present invention, e.g. aimed at controlling and stimulating blinking and/or tears production, by integrating the stimulator in or mounting the stimulator on standard glasses, and in particular in / on the suitable components of glasses, for example, the nose pads and possibly also temples. Integrating or mounting the stimulator or at least the part thereof defining the interface region, i.e. the arrangement / matrix of the stimulating elements, within or on the glasses, and in particular in nose pads of the glasses, provides that the electrodes may be properly adhered to the skin through pressure exerted by the structure of the glasses themselves and their own weight. Also, this allows easy removal and replacement of the stimulator arrangement or parts thereof. It should be understood, and also indicated above, that standard glasses / spectacles that can serve the appliance for integration therein or mounting thereon the stimulator (medical device) of the present invention, may be typical vision correcting glasses, or regular or vision correcting sunglasses, or virtual/augmented-reality glasses.

The above is exemplified in Figs. 4A-4F. Fig. 4A schematically illustrates standard glasses 130 configured as appliance carrying the stimulator 105 of the invention configured to be operable in accordance with individual- specific sensitivity map data for each of individual's eyes. As mentioned above, generally, the sensitivity map data indicative of the selected sub-array of the stimulating elements may be different for left and right eyes of the same individual. This is properly inspected and defined at the calibration stage, which will be described further below. In this example, the stimulator 105 includes two stimulator arrangements 110 relating to the left and right eyes of the individual. Also, in the present example, the stimulator arrangement is configured to generate electric stimulating signals and configured as described above, namely including the first electrode elements and a common second electrode. Further in this specific not limiting example, the same second electrode is common for the arrays of first electrode elements of both stimulator arrangements 110.

The arrangements of first electrode elements 116 are integral in the nose pads 132 of the glasses, and the second electrode 118 is integrated in the temples portion 134 of the glasses. Also, located in the temples portions of the glasses are functional elements of the electronic circuitry (107 in Fig. 1), such as actuator 112 (operable as a pulse generator) and local controller 108 and possibly also a wireless module 135. As also exemplified in the figure, the sensing system 122 is properly mounted on the glasses, e.g. on the frame portion.

It should be noted that the stimulator 105 may be an autonomous integral unit configured to be mountable on the glasses, e.g. on the nose pads interface 138. Fig. 4B is a picturized illustration of glasses carrying the stimulator 105 of the invention configured as described above.

Fig. 4C illustrates a somewhat modified design of glasses 140 enabling simple integration of the stimulator 105 therein. The optical / lens portion 142 of the glasses is of a standard configuration, while each of the temples 144 is configured as a two-part unit, one part 144A being integral with the lens portion 142 and the other part 144B being removably connectable with the part 144A (e.g. via magnetic elements). The part of the stimulator including the first electrode elements 116 is configured for mounting on the nose pads and nose pads interface, while the second electrode and the elements of the electronic circuitry (not specifically shown here) and located in the removable parts 144B of the temples. As shown in Fig. 4D, coupling between the temples’ parts 144A and 144B implements the electrical connection between the first and second electrodes and allows operation of the stimulator.

Fig. 4E schematically exemplify the glasses (130 or 140) being worn by the individual and illustrates how one of the interface region of the stimulator defined by the nose pad of the glasses is projected on the nerve circuitry in the respective facial region of interest.

Fig. 4E illustrates glasses 130 carrying the stimulator 105 of the present invention (integral with or mounted on the glasses as described above) placed on a wireless charger 160 thereby enabling charging of the batter of the stimulator.

Accurate positioning of the stimulation elements (first electrodes) over the motor nerve branches is critical for the successful activation of muscle contraction. A number of motor and sensory nerves are dispersed under the skin around the eye but not all generate a blink. Some generate other facial movements while others generate pain sensation. For the stimulation effect to be effective and tolerable generating a blink might not be enough. The blink is to be complete (fully closing the eye), painless and selective - one that generates only a blink and no other facial movements. The way to achieve this goal is by positioning the electrode directly above a nerve generating a blink in a section/location of the nerve that is far enough from another nerve and to use the least stimulation magnitude possible for a complete blink. Even a slight movement of the electrode can disrupt the efficiency of the blink, generate pain or activate other muscles. Hence, identification and activation of the suitable / correctly located stimulating element(s) (electrodes) is important to properly perform the stimulation session.

The array or matrix of the stimulating elements presents a so-called "electrically conductive pixels", each of which may function as an independently controlled stimulating element (electrode). As described above, such array of electrodes, defining an interface region of the stimulator, may be configured to be positioned on skin surface above the motor nerves in the region of interest. As will be described more specifically further below, a calibration process may be employed once to identify user-specific (and possibly eye-specific) sensitivity map data and determine the corresponding characteristic optimal combination of pixel activations for inducing muscle contraction while reducing or minimizing pain and discomfort. Moreover, the technique of the present invention allows flexibility (less accuracy or precision) in positioning the entire interface region (electrodes' matrix or array) over the nerve or nerve circuitry because of the ability of selection of specific electrodes (specific locations) to be addressed in the stimulation session. The personalized stimulator of the present invention allows to involve in the device operation a selected group / sub -array of the first electrode elements / segments (i.e. a pattern of the first electrode elements independently devised for each eye) to stimulate the blinking function of the eyes. Such personalized selection of the sub-array of individually operated electrode elements is needed because the location map of nerves that are to be electrically activated to cause the periocular muscles' contraction is different within facial structures of different individuals. Moreover, applying electrical signals to other locations within the individual face aligned with / facing the electrode might cause discomfort of the individual and should thus be avoided.

As described above, calibrating the stimulator to define the sub-array of electrode elements to be used in treatment session for specific individual can be performed once resulting in generation of sensitivity map data (per region of interest for each eye). This can be performed as follows:

Turning now to the above described Fig. 1 as well as to Fig. 5, the appliance 105 with the stimulator (stimulator arrangement 110 and electronic circuit 107) is brought in place, e.g. the glasses with the first electrode elements 116 in the nose pads and the other functional parts in the temples are worn by the individual, and the stimulating elements SE (first electrode elements) are sequentially individually activated/addressed by the controller 108 and the actuator circuit 112 (power supply creating a potential difference between the addressed first electrode and the second electrode) to generate a stimulating electrical signal at the respective location on individual's face. Individual's response data to such stimulating signal is monitored. For each stimulating signal generated by each stimulating element, the response data includes objective data (stimulation related data) about the blinking effect condition (e.g., whether full closure of the eye is achieved), and subjective data about pain / discomfort feeling of the individual caused by this stimulating signal. This subjective data may, generally, be in the form of individual's input about his/her personal feelings (pain/discomfort).

Preferably, however, alternatively or additionally to such individual's input, the subjective data is collected via imaging technique, i.e. includes analysis of image data collected from the individual's face to leam about individual's reaction to the applied stimulating signals via his/her face motion (mimics). To this end, the calibration stage may utilize the calibration system 120 including at least one imager (camera) 140 and an image processor software 142.

It should be understood that the image processor 142 is typically preprogrammed with reference data of the normal face mimics and a degree of change / fluctuation of the face mimics classified as abnormal condition. For each stimulating element being checked during the calibration stage, detection in the response data presence of both of the condition of sufficient stimulating effect (full eye closure during blinking and/or tears production) and normal or allowed/accepted degree of change from normal condition of the face mimics, results in selection of the respective stimulating element for inclusion in the sub-array of such elements. Alternatively, the processor can be preprogrammed to reject the stimulating element from being included in the sub-array of operative elements upon identifying absence in the detected response data of either one or both of the condition of insufficient stimulating effect and abnormal condition of the face mimics, such that the remaining non-rejected stimulating elements form the selected sub-array of the stimulating elements.

Additionally, the calibration procedure may be configured to determine signal strength, and/or pattern/waveform, and/or time pattern for each pixel/electrode element of the matrix.

As described above, the stimulator may be associated with the sensing system (122 in Fig. 1) which includes an imaging system. So, such sensing system may be used in the calibration stage.

As exemplified in Fig. 5, the calibration system 120 may utilize an individual's personal communication device 148, such as his/her phone device, which is properly installed with an image processing software (mobile application) configured as described above. Such software application can be downloaded from a respective server via communication network. Alternatively, the personal communication device may be in data communication with the remote server which is responsive to the image data receive from the phone device to run the image processing and return the result (selection or rejection of the stimulating element) to the electronic circuit 107 of the stimulator, either directly or via the phone device. As also exemplified in Fig. 5, alternatively or additionally, the calibration system 120 may include a camera/imager 150 mounted on the appliance itself (on the frame of glasses) and the image processor 152 may be part of the electronic circuit 107.

The above-described calibration stage results in the individual- specific sensitivity map data SMD which is stored in the memory of the electronic circuit 107 and/or of the smartphone device 138 and is then used to activate the personalized selected sub-array of the stimulating elements to perform each stimulating session.

The individual can then use his personalized stimulator, e.g. a wearable device, which can be operated using a set of interfaces on the device and a mobile application on a computerized end user device such as a smartphone 138.

As described above, the applicator may utilize / be used with the imaging system, e.g. sensing system 122, which may aid in finding the correct position of the device on the individual's face and selection of the operative sub-array (as described above) and assist in repositioning it in future usage. This technique facilitates rapid end user device personal calibration as needed.

It should be noted that, while utilizing the same stimulator, i.e. the same arrangement of stimulating elements, different sub-arrays / groups of the stimulating elements can be optimal for different eye functions, in particular stimulation of blinking effect and tears' production effect.

In this connection, reference is made to Figs. 6A to 6C exemplifying different stimulation patterns (selected sub-arrays of stimulating elements) and their effects selected in accordance with sensitivity map data of the specific individual. Fig. 6A exemplifies a stimulator arrangement incorporated in the appliance, e.g. nose pad of glasses. The stimulator arrangement includes the matrix/array of multiple stimulating elements defining / covering all together the interface region IR. This interface region is aligned with / located over the nerve circuitry of the facial region. This nerve circuitry includes zygomatic nerve whose stimulation allows for triggering blinking effect, infratrochlear nerve whose stimulation allows for triggering tears production, and also includes irrelevant branches of the facial nerve including sensory branches of the trigeminal nerve in this area.

Fig. 6B shows the selected sub-array SAi of the stimulating elements forming a pattern that triggers tearing by stimulating only the infratrochlear nerve, while not causing blinking effect and providing minimal discomfort for the specific individual. Fig. 6C shows the selected sub-array SA2 of the stimulating elements from said arrangement forming a pattern that triggers blinking effect with minimal discomfort for the specific individual by stimulating only the zygomattic nerve.

As can be understood from Fig. 6A, in case the entire interface region is activated using all the stimulating elements in the matrix, blinking would be triggered via zygomatic nerve, tearing would be triggered via the infratrochlear nerve, while at the same time various undesirable effects would be triggered. These include unwanted eyebrows/nose movement through irrelevant branches of the facial nerve, which will cause discomfort by stimulating many sensory branches of the trigeminal nerve in this area.

Thus, the same stimulator arrangement (array of stimulating elements) can be used to selectively activate different sub-arrays thereof to generate different stimulating signals stimulating different parts of the nerve circuitry in the region of interest covered by / aligned with the interface region defined by the stimulator arrangement, and accordingly providing different stimulating effects. This is also exemplified in Figs. 7A and 7B. Fig. 7A illustrates that by actuating the selected sub-array SEi of the stimulator arrangement and leaving the stimulating elements SE2 inactive, the stimulating signals affect only the nerve(s) NCi of the nerve circuitry in the region of interest causing blinking effect while eliminating the tears production. Fig. 7B illustrates that by actuating the selected sub-array SE2 of the same stimulator arrangement and leaving the stimulating elements SE2 inactive the stimulating signals affect only the nerve(s) NC2 of the same nerve circuitry in the region of interest causing the tears production with no blinking effect.

It should be noted that unilateral facial paralysis is the situation where one side of the face is healthy while the other side is paralyzed and unable to blink. The technique of the present invention provides for bilateral blink synchronization, including the inducing of artificial eye closure on both sides, thus significantly reducing the number of spontaneous blinks, and eliminating the necessity of detecting them.

In some examples, monitoring devices may be employed configured to assess of sufficient blinking by analyzing eyelid position during activation. To this end, as described above, the sensing system can be used. This provides the individual with an adaptive tool for personal calibration of the device operation.

In some use examples, no attempt may be made to synchronize facial expressions by blink detection and using source-detector pairs. Instead, both face sides are simultaneously or asynchronously activated, whether the nerve is paralyzed or healthy.

Considering incorporation of the stimulator of the present invention is glasses, the glasses can include various parts that can be quickly and securely assembled and disassembled to enable easy replacement and personalization.

The electrodes can be detached from the frame, and the frame can be detached from the temples. This enables replacement of different parts, for example personalized frames can be selected for different scenarios (personalized frame for face type and style). The temples of the glasses may use conductive hinges that shut off when the glasses are folded to prevent accidental activation when not in use.

In addition, the device may include a condensed electrode matrix in proximity to a specific branch of the facial nerve, e.g., to stimulate a specific movement.

It should also be noted that one or more additional stimulators may be together with the above-described device of the present invention. Such additional stimulator(s) may or may not be integral with the same appliance. The additional stimulator may be responsive to the sensing data (typically Image data as described above) and may include, for example a physical assembly of any suitable type adapted to notify / bring the individual's attention that blinking is needed, via physical contact (e.g. of a specific pattern) and/or may include software application installed in the individual's personal electronic device (computer, phone, watch) to induce voluntary eye blinking (conscious blinking).

It should be noted that any digital computer system, unit, device, module and/or engine exemplified herein can be configured or otherwise programmed to implement the technique of the invention as described above. The software products/applications needed to implement the invention, as described above, may be implemented as a computer program product that may be tangibly embodied in an information carrier including, for example, in a non-transitory tangible computer-readable and/or non-transitory tangible machine-readable storage device. The computer program product may directly loadable into an internal memory of a digital computer, comprising software code portions for performing the processes as disclosed above.

The processes described above may be implemented as a computer program that may be intangibly embodied by a computer readable signal medium. A computer readable signal medium may include a propagated data signal with computer readable program code embodied therein, for example, in baseband or as part of a carrier wave. Such a propagated signal may take any of a variety of forms, including, but not limited to, electro-magnetic, optical, or any suitable combination thereof. A computer readable signal medium may be any computer readable medium that is not a non-transitory computer or machine-readable storage device and that can communicate, propagate, or transport a program for use by or in connection with apparatuses, systems, platforms, methods, operations and/or processes discussed herein.

The terms "non— transitory computer— readable storage device" and "non- transitory machine-readable storage device" encompasses distribution media, intermediate storage media, execution memory of a computer, and any other medium or device capable of storing for later reading by a computer program implementing embodiments of the technique described above. A computer program product can be deployed to be executed on one computer or on multiple computers at one site or distributed across multiple sites and interconnected by one or more communication networks.

The term "engine" may comprise one or more computer modules, wherein a module may be a self-contained hardware and/or software component that interfaces with a larger system. A module may comprise a machine or machines executable instructions. A module may be embodied by a circuit, or a controller programmed to cause the system to implement the method, process and/or operation as disclosed herein. For example, a module may be implemented as a hardware circuit comprising, e.g., custom VLSI circuits or gate arrays, an application-specific integrated circuit (ASIC), off-the-shelf semiconductors such as logic chips, transistors, and/or other discrete components. A module may also be implemented in programmable hardware devices such as field programmable gate arrays, programmable array logic, programmable logic devices and/or the like. It is appreciated that certain features of the invention, which are, for clarity, described in the context of separate embodiments or example, may also be provided in combination in a single embodiment. Conversely, various features of the invention, which are, for brevity, described in the context of a single embodiment, example and/or option, may also be provided separately or in any suitable sub-combination or as suitable in any other described embodiment, example or option of the invention. Certain features described in the context of various embodiments, exam pies and/or optional implementation are not to be considered essential features of those embodiments, unless the embodiment, example and/or optional implementation is inoperative without those elements.