System and device for monitoring eye and eyelid motion

Abstract

A system (100) for monitoring eyelid motion includes an eyelid-mounted device (10) attached to an external surface of an eyelid. The eyelid-mounted device (10) includes a sensor (14, 16, 18) configured to sense motion or deformation of the eyelid. The sensor may be a motion sensor (14, 16) such as an accelerometer, or a deformation sensor (18) such as a piezoelectric film. A processing system (20, 48, 50, 62) receives signals from the sensor and processes the signals to determine a parameter relating to motion of an eye and / or the eyelid. The processing system may be onboard the eyelid-mounted device (10) or may be external to the eyelid-mounted device.

Description

[0001] System and Device for Monitoring Eye and Eyelid Motion

[0002] FIELD AND BACKGROUND OF THE INVENTION

[0003] The present invention relates to systems and devices employing eyelid-mounted sensors for monitoring physiological parameters, and corresponding applications.

[0004] Eye and eyelid movement patterns provide valuable insights into various physiological and neurological conditions. Such insights can be used in medical diagnosis and monitoring, as well as in other applications such as driver alertness monitoring. Conventional devices often rely on indirect measurements, such as heart rate or activity levels, to infer states of arousal and neurological health. These indirect methods lack the precision and specificity of direct eye movement measurement. Electrooculography (EOG) offers a direct measurement technique but is limited to controlled clinic environments due to its cumbersome setup and reliance on measuring voltage potential due to muscle tension.

[0005] SUMMARY OF THE INVENTION

[0006] The present invention is a system and device for monitoring eye and eyelid motion.

[0007] According to the teachings of an embodiment of the present invention there is provided, a system for monitoring eyelid motion, comprising: (a) an eyelid-mounted device configured to be attached to an external surface of an eyelid, the eyelid-mounted device comprising at least one sensor configured to sense motion and / or deformation of the eyelid; and (b) a processing system configured to receive signals from the at least one sensor and to process the signals to determine at least one parameter selected from the group consisting of: (i) eye movement; and (ii) complex eyelid motion.

[0008] According to a further feature of an embodiment of the present invention, the eyelid-mounted device comprises at least one motion sensor and at least one deformation sensor.

[0009] According to a further feature of an embodiment of the present invention, the processing system is further configured to delink motion of the eyelid and eye from i motion of the body based on signals received from both the motion sensor and the deformation sensor.

[0010] According to a further feature of an embodiment of the present invention, the eyelid-mounted device comprises a three-axis accelerometer.

[0011] According to a further feature of an embodiment of the present invention, the processing system is configured to determine an inclination of the head based on signals received from the three-axis accelerometer.

[0012] According to a further feature of an embodiment of the present invention, the processing system is further configured to correlate the determined inclination of the head with blink-related motion to monitor compliance with a treatment regimen for eyedrops.

[0013] According to a further feature of an embodiment of the present invention, the eyelid-mounted device is implemented as a flexible patch configured to conform to the instantaneous curvature of the eyelid, and the eyelid-mounted device comprises a piezoelectric film.

[0014] According to a further feature of an embodiment of the present invention, the eyelid-mounted device is implemented as a flexible patch configured to conform to the instantaneous curvature of the eyelid, and the eyelid-mounted device comprises an array of at least two three-axis accelerometers.

[0015] According to a further feature of an embodiment of the present invention, the processing system is further configured to differentiate between eye movement and blink- related motion.

[0016] According to a further feature of an embodiment of the present invention, the processing system is further configured to differentiate between horizontal and vertical eye movement.

[0017] According to a further feature of an embodiment of the present invention, the processing system is configured to analyze eyelid motions after drug administration to determine an intensity and duration of discomfort.

[0018] According to a further feature of an embodiment of the present invention, the processing system is configured to analyze variations in eye movement patterns to detect dry eye conditions. According to a further feature of an embodiment of the present invention, the processing system is configured to analyze eye movement and blink-related motion to detect drowsiness.

[0019] According to a further feature of an embodiment of the present invention, the processing system is configured to analyze eye movements while the eyelid is closed during sleep.

[0020] According to a further feature of an embodiment of the present invention, the eyelid-mounted device further comprises a wireless communication module configured to transmit data related to the signals to the processing system.

[0021] According to a further feature of an embodiment of the present invention, the array of motion sensors comprises at least three motion sensors arranged in a non-collinear configuration.

[0022] According to a further feature of an embodiment of the present invention, the eyelid-mounted device is further configured to be attached to an upper eyelid.

[0023] According to a further feature of an embodiment of the present invention, the eyelid-mounted device is further configured to be attached to a lower eyelid.

[0024] There is also provided according to the teachings of an embodiment of the present invention, a system for monitoring eyelid motion, comprising: (a) an eyelid-mounted device configured to be attached to an external surface of an eyelid, the eyelid-mounted device comprising: (i) a flexible patch configured to conform to the instantaneous curvature of the eyelid; and (ii) an array of at least two motion sensors associated with the flexible patch; and (b) a processing system configured to receive signals from the array of motion sensors and to process the signals to determine at least one parameter relating to motion of an eye and / or the eyelid.

[0025] There is also provided according to the teachings of an embodiment of the present invention, a system for monitoring eyelid motion, comprising: (a) an eyelid-mounted device configured to be attached to an external surface of an eyelid, the eyelid-mounted device comprising: (i) a flexible patch configured to conform to the instantaneous curvature of the eyelid; and (ii) a deformation sensor associated with the flexible patch; and (b) a processing system configured to receive signals from the deformation sensor and to process the signals to determine at least one parameter relating to motion of an eye and / or the eyelid.

[0026] There is also provided according to the teachings of an embodiment of the present invention, a system for synchronizing blinking of two eyes, comprising: (a) an eyelidmounted device configured to be attached to an external surface of an eyelid of a first eye, the eyelid-mounted device comprising: (i) at least one sensor configured to sense motion or deformation of the eyelid; and (ii) a communication module; and (b) a blinktriggering device in wireless communication with the eyelid-mounted device, the blinktriggering device configured to generate an output for inducing blinking motion of a second eye, wherein the blink-triggering device is responsive to a signal from the communication module upon sensing of a blink motion of the first eye to generate the output for inducing blinking.

[0027] BRIEF DESCRIPTION OF THE DRAWINGS

[0028] The invention is herein described, by way of example only, with reference to the accompanying drawings, wherein:

[0029] FIG. 1 is a schematic plan view illustrating an eyelid-mounted device that is part of a system, constructed and operative according to an embodiment of the present invention, for monitoring motion of the eyelid;

[0030] FIGS. 2A and 2B are vertical cross-sectional views through the eye of a user showing the eyelid in a closed and an open state, respectively, and showing the eyelidmounted device;

[0031] FIGS. 3 A and 3B are horizontal cross-sectional views through the eye of a user illustrating the deformation of the eyelid and eyelid-mounted device as the eye moves from a forward-facing direction to a left-facing direction, respectively;

[0032] FIG. 4A is a front view of a user showing placement of an eyelid-mounted device;

[0033] FIGS. 4B-4D are isometric views of a user showing placement of an eyelidmounted device and a separately mounted processing unit;

[0034] FIG. 4E is a partial view similar to FIG. 4A illustrating placement of the eyelidmounted device on the lower eyelids of the subject; FIG. 5 is an isometric view of a system for synchronizing blinking of two eyes;

[0035] FIG. 6 shows two graphs of accelerometer outputs during administration of eyedrops;

[0036] FIG. 7 shows analysis of accelerometer output signals to determine stages and cycles of sleep; and

[0037] FIGS. 8 A and 8B are histograms of blinking interval for a healthy patient and for a patient suffering from dry eye disease, respectively.

[0038] DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0039] The present invention is a system and device for monitoring eye and eyelid motion.

[0040] The principles and operation of systems and devices according to the present invention may be better understood with reference to the drawings and the accompanying description.

[0041] Referring now to the drawings, and more particularly to FIG. 1, an exemplary embodiment of a system 100 for monitoring eyelid motion includes an eyelid-mounted device 10 configured to be attached to an external surface of an eyelid. Eyelid-mounted device 10 has at least one sensor configured to sense motion and / or deformation of the eyelid. System 100 further includes a processing system configured to receive signals from the at least one sensor and to process the signals to determine at least one parameter relating to motion of an eye and / or the eyelid. The processing system may comprise any combination of an onboard processor (included in eyelid-mounted device 10 in the embodiment of FIG. 1) and / or an external processor (such as device 62 of FIG. 1 or units 48 or 50 of FIGS. 4B-4D, all as will be discussed further below).

[0042] Eyelid-Mounted Device

[0043] The eyelid-mounted device 10 is configured to be attached to an external surface of an eyelid. In certain embodiments, device 10 is implemented as a flexible patch 12 configured to conform to the instantaneous curvature of the eyelid. The flexible patch 12 may be made of a biocompatible and hypoallergenic material, such as a biocompatible elastomer or a low hardness polymer encapsulation, to ensure comfort and minimize irritation during prolonged use. Patch 12 may also include an adhesive layer 38 (see FIGS. 2A and 2B) to securely attach it to the eyelid.

[0044] The eyelid-mounted device 10 is designed to be thin and lightweight, allowing for comfortable and discreet wear. In certain embodiments, device 10 has a thickness of less than 1.5 mm, enabling it to fit within the epicanthal folds 36 of the eye without causing discomfort or interfering with normal eyelid movement, as shown in FIGS. 2 A and 2B.

[0045] Eyelid-mounted device 10 incorporates at least one sensor to capture data related to eye and eyelid movement. In certain embodiments, device 10 includes multiple sensors and / or sensors of different types to enhance the accuracy and range of measurements. As shown in FIG. 1, device 10 may include at least one motion sensor, such as accelerometers 14, 16 and optionally also gyroscopes (which are not shown separately in FIG. 1 but may be implemented as combined sensors 14, 16). The accelerometers 14, 16 are most preferably three-axis accelerometers to capture motion in all three dimensions. In some embodiments, device 10 includes an array of at least two accelerometers 14, 16 spaced apart at different regions of device 10. In certain particularly preferred implementations, at least three accelerometers may be arranged in a non-collinear configuration (not shown) to enable more precise tracking of eye movements.

[0046] In addition, or as an alternative, to the motion sensors, eyelid-mounted device 10 may include at least one deformation sensor, such as a piezoelectric film 18. The deformation sensor 18 is sensitive to changes in the shape or strain of the eyelid, providing additional information about eyelid movement and potentially also eye movement through the eyelid. Other types of deformation sensors, such as capacitive or inductive sensors, may also be used.

[0047] In certain embodiments, the eyelid-mounted device 10 further includes optional sensors to capture additional physiological parameters. As shown in FIG. 1, these may include a temperature sensor 26 to measure body temperature and an SpO2 sensor 28 to measure blood oxygen saturation. The SpO2 sensor 28 may utilize light-emitting diodes (LEDs) 30, 32 and a photodetector 34 to measure the absorption of light at different wavelengths and calculate oxygen saturation levels. In certain embodiments, one or both of temperature sensor 26 and SpO2 sensor 28 may be omitted from the eyelid-mounted device 10 and instead be incorporated into the separately mounted unit, such as temple- mounted unit 50 of FIGS. 4C and 4D. Where present on the eyelid-mounted device, both SpO2 sensor 28 and temperature sensor 26 are deployed at or near the skin contact surface of device 10 so as to interface directly with the skin of the eyelid for accurate measurement.

[0048] The eyelid-mounted device 10 may also include a processing unit 20 to process the signals from the various sensors. Processing unit 20 may perform tasks such as filtering, amplification, digitization, and preliminary analysis of the sensor data. In some embodiments, the processing unit 20 may be powerful enough to perform complex algorithms for motion and deformation analysis, delinking eye and eyelid motion from body motion, and determining various parameters related to eye movement, eyelid motion, and physiological conditions. In many cases, however, it is preferable to limit the functions of processing unit 20 to onboard control functions and / or data preprocessing, while heavier processing tasks (described further below) are performed by a processing system external to the device.

[0049] Figures 4A-4D illustrate various configurations for system 100. In the embodiment of FIG. 4A, eyelid-mounted devices 10 are attached to the upper eyelids of both eyes, and the processing system may be incorporated in either or both of these devices 10 or may be located externally. The simultaneous use of devices 10 for both eyes allows derivation of additional valuable data by identifying differences or mismatches between the measurements for the two eyes, or by pooling the data for increased accuracy. Binocular deployment may facilitate estimation of distance from the comparative gaze direction, while asynchronous motion may indicate drowsiness or various neurological conditions.

[0050] Although illustrated here primarily mounted on the upper eyelid, device 10 may equally be placed on the lower eyelid, as shown in FIG. 4E, where it is effective to recover data similar to a unit mounted on the upper eyelid. In some cases, mounting on eyelid- connected tissue at the inner or outer comer of the eye may also be suitable.

[0051] In the embodiment of FIG. 4B, a single eyelid-mounted device 10 is attached to one upper eyelid and is connected via wires 52 to an over-the-ear unit 48 which houses the processing system and other components such as a battery and communications unit. In the embodiment of FIG. 4C, a single eyelid-mounted device 10 is attached to one upper eyelid and is connected via wires 52 to a temple-mounted unit 50 which houses the processing system and other components. In the embodiment of FIG. 4D, a single eyelidmounted device 10 is attached to one upper eyelid and communicates wirelessly with a temple-mounted unit 50 which houses the processing system and other components.

[0052] Device 10 may be powered by a miniature battery 22 or other suitable power source. Device 10 typically includes a wireless communication module to transmit data to an external part of the system. This communication module may utilize Bluetooth Low Energy (BLE) or other suitable wireless communication protocols. In certain cases, particularly where device 10 is tethered via a wired connection to a separately mounted unit 48 or 50 (FIGS. 4B and 4C), the battery, processing unit and communications components of device 10 may be deployed in the separately mounted unit.

[0053] The temple-mounted unit 50 may also incorporate additional sensors, such as a temperature sensor and an SpO2 sensor, to measure body temperature and blood oxygen saturation, respectively. These sensors may be particularly useful in embodiments where they are omitted from the eyelid-mounted device 10, thereby minimizing the size, weight and energy consumption of onboard components, and avoiding any potential discomfort or interference with the user's vision that might be caused by the SpO2 light sources. System Architecture and Operation

[0054] As previously discussed, system 100 for monitoring eyelid motion generally includes an eyelid-mounted device 10 and a processing system. As shown in FIG. 1, in certain embodiments, the eyelid-mounted device 10 may include an onboard processor 20 that performs at least some of the functions of the processing system. In other embodiments, the processing system may be external to the eyelid-mounted device 10 and may be implemented, for example, as another external device 62 such as a cellphone or, in the cases of FIGS. 4B-4D, as a separately-mounted body-worn unit 48 or 50. The processing system receives signals from the sensor(s) on eyelid-mounted device 10 and processes these signals to determine various parameters related to eye and eyelid movement.

[0055] System 100 operates by first acquiring raw sensor data from the eyelid-mounted device 10. The sensors on device 10 continuously monitor the motion and / or deformation of the eyelid, generating electrical signals that correspond to these movements. These signals may be amplified, filtered, and digitized by the onboard processor 20 to generate data for transmission to the external processing system via the wireless communication module.

[0056] The processing system then analyzes the received sensor data using various algorithms and techniques. These algorithms may include:

[0057] • Motion and deformation analysis: The system may employ algorithms to analyze the raw sensor data and extract meaningful information about the motion and deformation of the eyelid. This may involve filtering out noise, identifying specific movement patterns, and calculating parameters such as velocity, acceleration, and displacement.

[0058] • Delinking eye and eyelid motion from body motion: In embodiments where the eyelid-mounted device 10 includes both motion and deformation sensors, the processing system may use the signals from both sensor types to distinguish between movements of the eye and eyelid relative to the body, and movements of the head or the entire body. Specifically, motion sensors such as accelerometers do not inherently distinguish between motion which results from eye or eyelid movement and motion which results from head or body motion. A deformation sensor, on the other hand, is impacted only by a change of shape of the eyelid surface, but not by head or body motion. As a result, fusion of the data from these two sensor types, such as by use of artificial neural networks or by suitable algorithm processing, allows reliable delinking of motion measurements for eye- related motion and other head (and body) motion. Additionally, or alternatively, particularly where a deformation sensor is not present, delinking of eye-related motion from head- and body-related motion may be achieved by filtering the frequency spectrum of the acceleration data, with higher frequency components typically relating to eye motion and lower frequency components originating from head and body motion. This delinking process helps to improve the accuracy and reliability of the eye and eyelid movement measurements.

[0059] • Eye Movement Determination: Whether the eyelid is open or closed, the movement of the eye underneath causes detectable motion and deformation of the eyelid due to the smaller radius of curvature of the cornea relative to the rest of the eyeball. The processing system leverages this relationship to estimate eye movement based on the sensor data. For example, in embodiments utilizing an array of accelerometers (as shown in FIG 3A and 3B), the relative timing and magnitude of the acceleration signals from different sensors on the patch can be used to infer the direction and speed of eye movement. Similarly, changes in the deformation patterns sensed by a piezoelectric film or other deformation sensors can also provide clues about the underlying eye movement. Sophisticated algorithms or suitably trained artificial neural networks may be employed to analyze these complex patterns and accurately estimate eye movement, both when the eye is open and when the eyelid is closed.

[0060] Based on the processed sensor data, the system 100 can determine various parameters related to eye and eyelid movement, including:

[0061] • Eye movement: The system may track the horizontal and vertical movements of the eye, even when the eyelid is closed. This information can be used for various applications, such as sleep monitoring, fatigue detection, and gaze tracking.

[0062] • Complex eyelid motion: The system may identify and classify different types of eyelid movements beyond simple blinks. In certain embodiments, “complex eyelid motion” is defined as eyelid movements that involve more than a simple opening and closing of the eyelid, such as partial blinks, fluttering, twitching, spasms, or combinations thereof. Complex eyelid motion does not include variations in blink rate or timing alone. This information can be useful for diagnosing and monitoring various medical conditions. The system may also detect “abnormal eyelid motion,” defined as any eyelid movement that deviates from normal blinking patterns, including but not limited to complex eyelid motion, changes in blink rate, and changes in blink duration.

[0063] • Physiological parameters: In embodiments where the eyelid-mounted device 10 includes additional sensors and / or through processing of motion data, the system may also determine physiological parameters such as pulse, oxygen saturation, and body temperature, and other biological markers. This data can provide further insights into the user's health and well-being. A biological marker is a measurable indicator of a physiological or pathological process or response to a therapeutic intervention.

[0064] The processing system may further compare the determined parameters to baseline measurements or predefined thresholds to identify deviations that may be indicative of a medical condition or other relevant events. For example, the system may detect abnormal eyelid motion patterns associated with dry eye disease or drowsiness, or it may identify changes in physiological parameters that suggest fatigue or stress.

[0065] The processed data and analysis results may be presented to the user through various means, such as a visual display on a connected device, audio feedback, or haptic alerts. The system may also store the data for future reference or transmit it to healthcare professionals or other authorized parties for further analysis and interpretation.

[0066] Specific Applications

[0067] A. Sleep Monitoring and Analysis

[0068] System 100 can be used to monitor and analyze various aspects of sleep, providing valuable insights into sleep quality, patterns, and potential disorders. By tracking eye movements and eyelid motion throughout the night, the system can identify different sleep stages, such as rapid eye movement (REM) and non-REM (NREM) sleep. The detection of rapid eye movements (REM) during sleep, characterized by quick, darting eye movements beneath closed eyelids, can be a key indicator of REM sleep, a stage associated with vivid dreams and memory consolidation.

[0069] A particular advantage of certain embodiments of system 100 is that, since the eyelid-mounted device 10 is in direct contact with the eyelid, it can directly sense eye movements through the closed eyelid, even during sleep. This allows for accurate and reliable identification of REM sleep and other sleep stages characterized by distinct eye movement patterns. This capability contrasts with many conventional sleep monitoring devices, such as smartwatches, which rely on indirect measurements like heart rate or body movement to infer sleep stages. These indirect methods are known to be less accurate and may misinterpret certain movements or physiological changes, leading to unreliable sleep stage identification. By directly measuring eye movements, system 100 offers a level of accuracy comparable to that of polysomnography (PSG), the gold standard for sleep analysis, but without the need for cumbersome and intrusive sensors typically used in sleep labs. This enables convenient and reliable sleep monitoring in the comfort of one's own home.

[0070] In addition to eye movement, the system may also utilize other sensors to gather additional data relevant to sleep analysis. For instance, the accelerometer in the eyelidmounted device 10 can be used to detect body movements during sleep, helping to identify periods of restlessness or awakenings, and can also help determine the posture of the body, identifying when and in what posture a person is reclining, or if he is sitting or standing upright. The SpO2 sensor 28, if present, can monitor blood oxygen saturation levels, which can be indicative of sleep apnea or other breathing disorders. Furthermore, the system can analyze snoring patterns by detecting vibrations or sound waves associated with snoring. This information can be used to assess the severity of snoring and identify potential risk factors for sleep apnea. As shown in FIG. 7, the analysis of accelerometer output signals can be used to determine stages and cycles of sleep, including multiple cycles each including deep sleep, light sleep, and REM sleep.

[0071] By combining data from various sensors and analyzing eye and eyelid movements, system 100 can provide a comprehensive assessment of sleep quality, including sleep duration, sleep stages, sleep efficiency, and the presence of any sleep disturbances. This information can be valuable for individuals seeking to improve their sleep habits, as well as for healthcare professionals diagnosing and managing sleep disorders.

[0072] B. Dry Eye Detection and Monitoring

[0073] Dry eye disease (DED) is a common condition that affects millions of people worldwide. It occurs when the eyes don't produce enough tears or the tears evaporate too quickly, leading to symptoms like dryness, irritation, and blurred vision. System 100 can be used to detect and monitor dry eye conditions by analyzing variations in eye movement and blinking patterns. As shown in FIGS. 8 A and 8B, the blinking interval (time between blinks) can be used to distinguish between a healthy patient and a patient suffering from dry eye disease. The most significant blink interval for a DED patient is much shorter compared to a healthy patient and the entire distribution for DED is heavily weighed to low values.

[0074] The system may establish a baseline of eye movements and blinking patterns when the eyes are not dry (e.g., after applying moisturizing eyedrops). It can then compare current eye movements and blinking patterns to this baseline to identify deviations indicative of dry eye conditions. The system may analyze various parameters, such as:

[0075] • Forced eye movements: These may occur due to discomfort caused by dry eyes.

[0076] • Rapid blinking rates: Dry eyes may trigger more frequent blinking in an attempt to spread tears across the eye surface.

[0077] • Maximum time eyes can be kept open: Individuals with dry eyes may have difficulty keeping their eyes open for extended periods.

[0078] • Histogram analysis of blinking intervals: This can reveal the most significant blinking interval and the Equivalent Breakup Time (EBT), which measures tear film evaporation time.

[0079] By continuously monitoring these parameters, system 100 can provide real-time feedback on the severity of dry eye conditions and the effectiveness of treatment options. This information can be valuable for individuals managing dry eyes and for healthcare professionals developing personalized treatment plans.

[0080] Furthermore, the combination of motion and deformation sensors in certain embodiments of system 100 allows for more reliable and detailed blink tracking, reducing false positives caused by head or body movements. This enhanced accuracy is particularly crucial in dry eye detection, as subtle variations in blinking patterns may be indicative of the condition.

[0081] C. Fatigue and Drowsiness Detection

[0082] Fatigue and drowsiness can significantly impair cognitive function and reaction times, posing serious risks in various settings, such as driving or operating machinery. System 100 can be used to detect signs of fatigue and drowsiness by analyzing eye movement and blinking patterns.

[0083] The system may establish a baseline of eye movements and blinking patterns when the individual is awake and alert. It can then compare current eye movements and blinking patterns to this baseline to identify deviations indicative of fatigue or drowsiness. The system may analyze various parameters, such as:

[0084] • Changes in blinking rate: Fatigue and drowsiness often lead to a decrease in blink rate or an increase in the duration of eye closure during blinks. • Changes in eye movement patterns: Slow or erratic eye movements may also be signs of fatigue or drowsiness.

[0085] The combination of motion and deformation sensors in certain embodiments of system 100 allows for more reliable and detailed blink tracking, reducing false positives caused by head or body movements. This enhanced accuracy is particularly crucial in drowsiness detection, as subtle changes in blinking patterns may be early indicators of fatigue.

[0086] By continuously monitoring these parameters, system 100 can provide real-time alerts to the individual or a monitoring system when signs of fatigue or drowsiness are detected. This can help prevent accidents and improve safety in various contexts, such as:

[0087] • Driver alertness: The system can be integrated into vehicles to monitor drivers' alertness and provide warnings if they show signs of drowsiness.

[0088] • Workplace safety: The system can be used in industrial settings to monitor workers' fatigue levels and prevent accidents caused by decreased alertness.

[0089] D. Eyedrop Application Monitoring

[0090] For individuals who require regular eyedrop administration, ensuring proper adherence to the prescribed treatment regimen is crucial for effective management of their condition. System 100 can be utilized to monitor and log eyedrop application events, providing valuable feedback to both patients and healthcare providers.

[0091] The system can detect unique blinking patterns that occur when eyedrops are applied. For example, it may recognize the characteristic blink that often follows the instillation of eyedrops, or it may identify head tilts and blinking responses associated with the application process. As shown in FIG. 6, the system may utilize accelerometer data to identify head tilting motions (e.g., where the acceleration due to gravity shifts from one axis to another due to tipping of the device) indicative of eyedrop administration, and also forceful blinking in response to discomfort following administration of the drops. By analyzing these patterns, the system can determine whether the eyedrops were applied correctly and record each application event digitally.

[0092] This information can help patients track their adherence to the prescribed eyedrop schedule and identify any missed doses. It can also provide healthcare providers with objective data on patient compliance, enabling them to tailor treatment plans and provide more effective care.

[0093] E. Discomfort Assessment from Eyedrop Medicine

[0094] Some eyedrop medications may cause temporary discomfort or irritation upon application. Understanding the level of discomfort experienced by patients can help pharmaceutical companies develop more comfortable formulations and improve the overall patient experience. System 100 can be used to objectively assess the discomfort caused by eyedrop medicines.

[0095] By analyzing blinking patterns before and after eyedrop application, the system can measure the intensity and duration of discomfort. It may track parameters such as:

[0096] • Strength of eye closing and opening: Discomfort may lead to more forceful blinking or difficulty in fully opening the eyes.

[0097] • Time intervals of eye closing and opening: The duration of blinks and the time between blinks may change in response to discomfort.

[0098] • Forced blinking patterns and eye movements: Patients may exhibit involuntary blinking or eye movements to alleviate discomfort.

[0099] • Time to return to baseline: The system can measure how long it takes for blinking patterns and eye movements to return to normal after eyedrop application, providing a comprehensive assessment of discomfort and recovery time. Figure 6 shows two graphs of accelerometer outputs during administration of eyedrops into the eye. More extreme transient acceleration peaks correspond to forceful blinking as a response to irritation or pain caused by the drops.

[0100] This objective data on discomfort can be valuable for pharmaceutical companies during drug development and clinical trials. It can help them identify formulations that cause less discomfort and optimize the user experience.

[0101] F. Neurological Condition Monitoring

[0102] The intricate relationship between eye and eyelid movements and neurological health makes the system 100 a valuable tool for monitoring and potentially diagnosing various neurological conditions. By tracking subtle changes in eye movement patterns, blinking behavior, and eyelid motion, the system can provide insights into the functioning of the nervous system and identify or monitor potential abnormalities. One specific example mentioned in the disclosures is the monitoring of neurotrophic keratitis (NK), a degenerative corneal disease characterized by reduced or absent comeal sensitivity. In NK patients, the comeal blink reflex, which triggers blinking in response to stimuli on the cornea, is impaired. This can lead to a decrease in blink rate, incomplete blinks, and increased latency between blinks. System 100 can detect these changes in blinking patterns, providing valuable data for assessing the severity of NK and monitoring the effectiveness of treatment options.

[0103] Furthermore, the system's ability to track eye movements even with closed eyelids can be useful in monitoring other neurological conditions that affect eye movement control, such as Parkinson's disease, multiple sclerosis, or stroke. By identifying subtle deviations from normal eye movement patterns, the system may aid in early detection and diagnosis of these conditions, enabling timely intervention and management.

[0104] G. Blinking Synchronization for Individuals with Facial Paralysis

[0105] In certain embodiments, system 100 can be used to synchronize the blinking of two eyes, particularly in individuals with facial paralysis or other conditions that affect their ability to blink naturally.

[0106] As shown in FIG. 5, an eyelid-mounted device 10 is attached to the eyelid of a healthy eye, and a separate blink-triggering device 56 is connected to electrodes 58, 60 placed near the eyelids of the affected eye. The eyelid-mounted device 10 senses the motion or deformation of the eyelid during blinking and transmits a signal to the blinktriggering device 56 via a wireless communication module. The blink -triggering device may be implemented, for example, in a manner similar to the device commercially available under the Tradename BlinkER™ from NeuroTrigger Ltd. (IL).

[0107] Upon receiving this signal, the blink-triggering device 56 generates an output, such as an electrical impulse, to stimulate the nerves or muscles around the affected eye, inducing a blinking motion. This synchronized blinking helps to maintain the natural appearance and function of both eyes, improving the individual's quality of life and social interactions.

[0108] This application demonstrates the versatility of the eyelid-mounted device 10 and its potential to address a wide range of medical and assistive technology needs. G. Hands-Free Control and Interaction

[0109] Beyond medical applications, system 100 also offers the potential for innovative hands-free control and interaction with devices and applications. By recognizing and interpreting intentional or passive blinking, winking, and eye movement patterns, the system can translate these natural gestures into commands or feedback signals.

[0110] This capability opens up new possibilities for individuals with limited mobility or those in situations where hands-free operation is desired or necessary. For example, the system could be used to control assistive technologies, navigate user interfaces, or interact with augmented reality environments, all through subtle eye and eyelid movements.

[0111] Conclusion

[0112] From the above description, it will be clear that various certain embodiments of the systems and devices described herein may offer some or all of a number of advantages:

[0113] • Enhanced accuracy and precision: The use of multiple sensor types and advanced algorithms enables more accurate and precise tracking of eye and eyelid movements, even with closed eyelids.

[0114] • Non-invasive and comfortable: The eyelid-mounted device is designed for comfortable and discreet wear, minimizing interference with normal activities and promoting long-term use.

[0115] • Real-time monitoring and analysis: The system provides real-time feedback on eye and eyelid movement patterns, enabling timely detection of potential issues and facilitating prompt intervention.

[0116] • Versatility and broad applicability: The system can be used for various applications, from sleep monitoring and dry eye detection to neurological condition monitoring and hands-free control.

[0117] • Objective assessment of discomfort: The system offers a quantitative way to measure discomfort caused by eyedrop medications, aiding in drug development and improving patient experience. Potential for early detection and diagnosis: By continuously monitoring eye and eyelid movements, the system may enable early identification of various health conditions, leading to timely intervention and improved outcomes.

[0118] It will be appreciated that the above descriptions are intended only to serve as examples, and that many other embodiments are possible within the scope of the present invention as defined in the appended claims.

Claims

WHAT IS CLAIMED IS:

1. A system for monitoring eyelid motion, comprising:(a) an eyelid-mounted device configured to be attached to an external surface of an eyelid, the eyelid-mounted device comprising at least one sensor configured to sense motion and / or deformation of the eyelid; and(b) a processing system configured to receive signals from the at least one sensor and to process the signals to determine at least one parameter selected from the group consisting of:(i) eye movement; and(ii) complex eyelid motion.

2. The system of claim 1, wherein the eyelid-mounted device comprises at least one motion sensor and at least one deformation sensor.

3. The system of claim 2, wherein the processing system is further configured to delink motion of the eyelid and eye from motion of the body based on signals received from both the motion sensor and the deformation sensor.

4. The system of claim 1, wherein the eyelid-mounted device comprises a three- axis accelerometer.

5. The system of claim 4, wherein the processing system is configured to determine an inclination of the head based on signals received from the three-axis accelerometer.

6. The system of claim 5, wherein the processing system is further configured to correlate the determined inclination of the head with blink-related motion to monitor compliance with a treatment regimen for eyedrops.

7. The system of claim 1, wherein the eyelid-mounted device is implemented as a flexible patch configured to conform to the instantaneous curvature of the eyelid, and the eyelid-mounted device comprises a piezoelectric film.

8. The system of claim 1, wherein the eyelid-mounted device is implemented as a flexible patch configured to conform to the instantaneous curvature of the eyelid, and the eyelid-mounted device comprises an array of at least two three-axis accelerometers.

9. The system of claim 1, wherein the processing system is further configured to differentiate between eye movement and blink-related motion.

10. The system of claim 9, wherein the processing system is further configured to differentiate between horizontal and vertical eye movement.

11. The system of claim 1, wherein the processing system is configured to analyze eyelid motions after drug administration to determine an intensity and duration of discomfort.

12. The system of claim 1, wherein the processing system is configured to analyze variations in eye movement patterns to detect dry eye conditions.

13. The system of claim 1, wherein the processing system is configured to analyze eye movement and blink -related motion to detect drowsiness.

14. The system of claim 1, wherein the processing system is configured to analyze eye movements while the eyelid is closed during sleep.

15. The system of claim 1, wherein the eyelid-mounted device further comprises a wireless communication module configured to transmit data related to the signals to the processing system.

16. The system of claim 1, wherein the array of motion sensors comprises at least three motion sensors arranged in a non-collinear configuration.

17. The system of claim 1, wherein the eyelid-mounted device is further configured to be attached to an upper eyelid.

18. The system of claim 1, wherein the eyelid-mounted device is further configured to be attached to a lower eyelid.

19. A system for monitoring eyelid motion, comprising:(a) an eyelid-mounted device configured to be attached to an external surface of an eyelid, the eyelid-mounted device comprising:(i) a flexible patch configured to conform to the instantaneous curvature of the eyelid; and(ii) an array of at least two motion sensors associated with the flexible patch; and(b) a processing system configured to receive signals from the array of motion sensors and to process the signals to determine at least one parameter relating to motion of an eye and / or the eyelid.

20. A system for monitoring eyelid motion, comprising:(a) an eyelid-mounted device configured to be attached to an external surface of an eyelid, the eyelid-mounted device comprising: (i) a flexible patch configured to conform to the instantaneous curvature of the eyelid; and(ii) a deformation sensor associated with the flexible patch; and(b) a processing system configured to receive signals from the deformation sensor and to process the signals to determine at least one parameter relating to motion of an eye and / or the eyelid.

21. A system for synchronizing blinking of two eyes, comprising:(a) an eyelid-mounted device configured to be attached to an external surface of an eyelid of a first eye, the eyelid-mounted device comprising:(i) at least one sensor configured to sense motion or deformation of the eyelid; and(ii) a communication module; and(b) a blink-triggering device in wireless communication with the eyelidmounted device, the blink-triggering device configured to generate an output for inducing blinking motion of a second eye, wherein the blink-triggering device is responsive to a signal from the communication module upon sensing of a blink motion of the first eye to generate the output for inducing blinking.

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