Non-invasive periorbital device for dry eye treatment and closed-loop method for operating the device

Abstract

An ocular component configured to be positioned within a user's eye socket includes a ring; a plurality of electrodes spaced along the ring; a microcontroller operatively coupled to the plurality of electrodes; and a sensor assembly coupled to the ring and operatively coupled to the microcontroller. A method of stimulating a user's lacrimal gland includes monitoring one or more eye conditions using the sensor assembly; determining, based on the monitored one or more eye conditions and using the microcontroller, whether the monitored one or more eye conditions exceed a predetermined threshold; and in response to the monitored one or more eye conditions exceeding the predetermined threshold, activating the plurality of electrodes using the microcontroller to stimulate the user's lacrimal gland.

Description

[0001] Cross - reference to related applications

[0002] This application claims the filing date and the benefit of priority of U.S. Application No. 62 / 824,132, filed on March 26, 2019, the entire disclosure of which is incorporated herein by reference. Background Art

[0003] Many people suffer from dry eye disease (“DED”), which includes symptoms such as severe pain, eye stinging, foreign body sensation, light sensitivity, blurriness, increased risk of infection, and possible vision loss.

[0004] DED is characterized by insufficient tear volume on the ocular surface of the patient, which is usually caused by insufficient tear production or excessive tear evaporation. Insufficient tear volume leads to too high tear osmolarity, which causes inflammation and nerve damage, and may lead to a gradual decline in tear production and quality.

[0005] Dry eye symptoms vary due to a variety of factors. For example, dry eye symptoms vary throughout the day with the diurnal physiological changes in tear pH, intraocular pressure, corneal sensitivity, visual sensitivity, and melatonin production. For example, corneal sensitivity is usually much higher in the evening compared to the morning. Long - term changes in dry eye symptoms may be related to systemic medications, chronic diseases (e.g., diabetes), hormonal changes, and aging. Changes in the patient's environment can also cause changes in dry eye symptoms. For example, due to the low humidity in air - conditioned offices, winter heating, computer use, phone use, allergens, and contact lenses, dry eye symptoms may increase.

[0006] Current methods for treating dry eye symptoms do not or cannot account for the various factors that affect symptom severity and onset, because current treatment for DED is mainly based on eye drops, which only provide limited temporary and short - term relief. Brief Description of the Drawings

[0007] Figure 1 is a diagram of a periorbital device worn around a user's eye and near the lacrimal gland according to an exemplary embodiment.

[0008] Figure 2 is according to an example embodiment of Figure 1 a schematic diagram of the device.

[0009] Figure 3 is a front - view diagram of a device, an eye, and a lacrimal gland according to an exemplary embodiment including Figure 1 ...

[0010] Figure 4 is a side - view diagram of a device, an eye, and a lacrimal gland according to an exemplary embodiment including Figure 1 ...

[0011] Figure 5 is a diagram of a cross-sectional view of a device according to an example embodiment Figure 1 .

[0012] Figure 6 is a diagram of a front view of a device according to an example embodiment Figure 1 .

[0013] Figure 7 is a schematic diagram of a device, a remote device, and another remote device connected via a network according to an example embodiment Figure 1 .

[0014] Figure 8 is a flowchart of a method of operating a device according to an example embodiment Figure 1-7 .

[0015] Figure 9 is a flowchart of steps in a method according to an example embodiment Figure 8 .

[0016] Figure 10 is a schematic diagram of a closed-loop system formed by a device according to an example embodiment during a method Figure 9 . Figure 1 .

[0017] Figure 11 is a schematic diagram of a node for implementing one or more example embodiments of the present disclosure according to an example embodiment DETAILED DESCRIPTION

[0018] The following disclosure provides many different embodiments or examples. Specific examples of components and arrangements are described below to simplify the present disclosure. Of course, these are merely examples and not restrictive. Additionally, the present disclosure may repeat reference numerals and / or letters in various examples. This repetition is for simplicity and clarity purposes and does not in itself dictate a relationship between the various embodiments and / or configurations discussed.

[0019] The present disclosure presents embodiments of devices having a unique form factor for providing dry eye treatment. For example, embodiments of a circumferential ocular nerve stimulator are presented for stimulating the lacrimal gland to stimulate tear production. In at least some embodiments, the ocular device rests on the eye surface, so dry eye treatment does not require surgery or an implantable or implant device. Some advantages include that the patient can perform specific, non-invasive, personalized dry eye treatment seamlessly throughout the day, synchronized with the patient's natural circadian rhythm changes, and personalized according to the patient's environment. Additionally, as further discussed herein, the form factor of the device allows sensors to be placed at different points around the perimeter or circumference of the device, allowing closed-loop control of stimulation based on measurements related to eye dryness.

[0020] As Figure 1As shown, the device, generally designated by reference numeral 10, is an exemplary circumferential periorbital device for nerve stimulation. When mounted on the eye, the device 10 is invisible or imperceptible to the user or others. Additionally, the device 10 does not obstruct the user's line of sight because the device 10 does not extend past the pupil, iris, limbal ring, etc. Thus, the device 10 can be used in conjunction with conventional vision correction devices such as contact lenses and glasses. The device 10 can be inserted into the periorbital space and is easily removable for cleaning and / or recharging. Accordingly, insertion and removal of the device 10 can be performed without surgery. In some cases, the user can insert and remove the device 10 in his or her home. The device 10 also provides hands-free stimulation. That is, since the device 10 includes electrodes for stimulating the lacrimal gland and a microcontroller for controlling the stimulation, and the user does not need to perform any activity to activate the electrodes. The stimulation can be based on a predetermined schedule stored in the device 10 or can be responsive to a detected or predicted dry eye condition. For example, when the user is performing another activity, such as viewing a graphical display on his or her mobile phone, the camera of the mobile phone may detect a blink rate indicative of the user experiencing dry eye symptoms. In response, the mobile phone wirelessly instructs the device 10 to activate the electrodes to stimulate the lacrimal gland. In some cases, the user is unaware of the detection, instruction, and activation. As needed, the user can use the device 10 in one eye or use the device in each eye (i.e., the user can use two devices 10, one for each eye). For ease of description, the present disclosure focuses on applying the device 10 to one eye, it being understood that the present disclosure can be applied to both eyes of the user.

[0021] In an exemplary embodiment and as Figure 1 shown, the device 10 generally includes a wearable band or ring 15 and a gland stimulator assembly 20. In some embodiments, the stimulator assembly 20 is considered part of the ring 15 because the stimulator assembly 20 is physically and electrically attached to the ring. The term "ring" as used herein generally refers to a substantially circular shape, but is not limited thereto, and can refer to an elliptical shape that surrounds and is spaced from a portion of the eye (e.g., the limbal ring). Generally, the device 10 is configured to surround the front portion of the user 40's eye 35 in the fornical region. For example, the device 10 can be worn outside the periphery of the user's iris, surrounding the iris, and radially spaced from the iris. The device 10 is positioned such that the gland stimulator assembly 20 is sufficiently close to the user 40's lacrimal gland 55 to stimulate tear production when an electrical signal is applied to the stimulator assembly. As is understood in the art, electrical stimulation of the known lacrimal gland 55 increases tear production.

[0022] The disclosed devices, systems, and methods are for treating the condition of DED in patients using chronotherapeutic methods. The chronotherapeutic methods are implemented by device 10, which provides glandular stimulation as needed. That is, in some embodiments, the glandular stimulation is synchronized with the circadian rhythm and other factors. For example, if symptom peaks occur during the day, glandular stimulation can be performed before or during symptom exacerbation, depending on the delay between stimulating the gland and producing additional tears.

[0023] As Figure 2 shown, the glandular stimulator assembly 20 generally includes an electrode 21, a microcontroller 22, and a wire assembly 23 that operably couples the electrode 21 to the microcontroller 22. Generally, the microcontroller 22 also includes or is operably coupled to a power source 24 and a memory 26. In some embodiments and when the power source 24 includes a battery, such as a lithium thionyl chloride battery cell, the battery has a terminal connected to an input of a voltage regulator that forms part of the microcontroller 22. The regulator smooths the battery output and powers the microcontroller 22, which controls the programmable functions of the stimulator assembly 20, including known stimulation parameters such as pulse amplitude (measured as current or voltage, e.g., 500 μA to 25 mA), pulse frequency, pulse width, and the on-time and off-time of the output pulses provided to the electrode 21. The microcontroller 22 is programmable because patient profiles can be stored in the memory 26. Using the patient profile, the microcontroller 22 regulates the electrical activity of the lacrimal gland to generate a treatment regimen suitable for the patient. Timing signals for the logic and control functions of the generator are provided by the memory 26.

[0024] In some embodiments, the patient profile stored in the memory 26 includes a time model that details the target stimulation parameters to be applied over a period of time. In some embodiments, the target stimulation parameters include amplitude or charge density (e.g., current or voltage), frequency, pulse width, on-time and off-time of the output pulses. The time model can detail treatment plans for daily, weekly, monthly, and / or seasonal cycles. In some cases, the time model is based on the patient / user's monitored eye condition, a chart of the patient / user's perceived symptoms, and / or a general time model of the patient: age, gender, weight, geographical location, occupation, activity level, or any combination thereof. Different combinations of stimulation parameters can be programmed into the memory (e.g., by a clinician) and selected by the patient. The patient's selection of a combination of stimulation parameters can be made via a software application on a smart phone and transmitted to the ring 15 via Bluetooth or other forms of wireless communication. As other examples, the ring 15 can be configured for near-field communication or inductive telemetry for communicating with a programming wand.

[0025] In some embodiments, the electrode 21 is located at the periphery of the ring 15 and is desirably positioned juxtaposed to the lacrimal gland 55 or the nerve when the user 40 wears the device 10. That is, when the device 10 is worn by the user 40, the microcontroller 22 applies an output signal to the lacrimal gland 55 via the wire assembly 23 and the electrode 21. In some embodiments, the electrode 21 is made of materials including Pt, Pt / Ir alloy, Ir, and other electrochemically stable high charge capacity metals and alloys. In some embodiments, direct stimulation of the lacrimal gland 55 via the gland stimulator assembly 20 causes a significant several-fold increase in tear production. In some embodiments, as Figure 5 and 6 shown, the electrodes 21 are spaced along the ring 15. In some embodiments, the electrodes are circumferentially spaced along the ring 15, radially spaced along the ring 15, and / or circumferentially spaced along the cross-section of the ring 15. For example, and referring to Figure 5 , the electrodes 21a and 21b are circumferentially spaced along the cross-section of the ring 15 and radially aligned, while the electrodes 21b and 21c are circumferentially and radially spaced along the cross-section of the ring 15. Referring to Figure 6 , the electrodes 21a and 21d are circumferentially spaced along the ring 15. In some embodiments, the electrode 21 can be configured as an electrode array for guiding the generated electric field to more effectively stimulate the lacrimal gland.

[0026] In some cases, and as Figure 3-6 shown, the device 10 includes a sensor assembly 58 for detecting dry eye symptoms to form a closed-loop dry eye treatment device. Thus, the device 10 enables the implementation of a customized stimulation curve for the treatment of DED. The frequency and duration of dry eye symptoms vary for each DED patient because dry eye symptoms are caused by multiple factors such as the local environment, health-related issues, and the time of day. Since the device 10 detects and then treats dry eye symptoms, the device 10 is a closed-loop dry eye treatment device 10. That is, the device 10 provides an automatic, customized treatment for DED and is a time-based treatment nerve stimulation system. The electrical stimulation of the lacrimal gland 55 and the nerve is only performed in a controlled manner when needed and based on the physiological parameters measured by the device 10 as well as personalized or local environmental and health factors.

[0027] In some embodiments, sensor assembly 58 includes one or more sensors and / or sensor types. For example, sensor assembly 58 includes sensors 58a, 58b, 58c, and 58d. For example, sensors 58a and 58b form a tear film breakup (“TFBU”) sensor system. Each of sensors 58a and 58b is a small electrode located approximately 180 degrees apart on the periphery of ring 15. The electrode material can be a suitable metal, including Pt, Pt / Ir alloy, Ir, and similar electrochemically stable metals. Generally, sensors 58a and 58b measure the resistivity of the tear film located between sensors 58a and 58b during the application of a small alternating current signal (e.g., 1 - 100 mV Pk - Pk) at a frequency higher than 1 kHz. At frequencies higher than 1 kHz, the composite signal is primarily a measure of the volume conduction path through the tear fluid located on the eye 35 and is thus a function of volume. As the tear film thins and breaks, a characteristic AC impedance can be measured and correlated with tear film dynamics. These dynamics can include tear film breakup time, evaporation rate, and total available volume. A faster breakup time is an indicator of overall dryness, including potential effects of environmental factors. Thus, sensors 58a and 58b, when configured to measure the TFBU time, determine the stability of the tear film and determine evaporative dry eye based on the resistivity of the tear film within region 70. Sensors 58a and 58b do not need to be located approximately 180 degrees apart on the periphery of ring 15, and in some embodiments, sensors 58a and 58b are spaced within 90 degrees (along the periphery of ring 15) to measure the TFBU time within a region smaller than region 70. In some embodiments and when sensors 58a and 58b are not spaced approximately 180 degrees apart, multiple pairs of sensors 58a and 58b are spaced around the periphery of ring 15, with each pair of sensors measuring a region or portion of the eye 35. Multiple pairs of sensors are used together to determine the tear film dynamics of the eye 35.

[0028] In some embodiments, sensor 58c is or includes a microelectrode pH sensor that monitors the pH level of the tear fluid, as it has been shown that tear fluid osmolality and pH are related to dry eye. In some embodiments, sensor 58c is positioned along ring 15 such that when ring 15 is positioned around the eye 35, sensor 58c is positioned in the upper fornix, lower fornix, and / or near the microcontroller 22 of the device 10 to ensure that sensor 58c remains in contact with the tear fluid. In some embodiments, sensor 58c is factory calibrated, but in other embodiments, the microcontroller 22 performs patient - specific calibration in a clinician's office or via a home system using standard tear sampling materials. In some embodiments, the upper fornix region is between the eye 35 and the eyelid 45, and the lower fornix region is between the eye 35 and the lower eyelid 50. However, in some cases, the upper fornix region is any upper region adjacent to the eye 35 (e.g., towards the user's eyebrow) and the lower fornix region is any lower region adjacent to the eye 35 (e.g., towards the user's chin).

[0029] In some embodiments and as Figure 6 shown, sensor 58d is a blink sensor. That is, sensor 58d is configured to monitor the blink rate of user 40. The blink time of a normal person typically averages 4 ± 2 seconds, while patients with dry eye exhibit a significantly reduced blink time averaging 1.5 ± 0.9 seconds in an attempt to maximize the tear supply to the ocular surface. Thus, the blink rate can be used to identify dry eye conditions. In particular, the reduction in blink time for a particular patient can be measured throughout the day and correlated with diurnal variations in physiological parameters such as corneal sensitivity. In some embodiments, blink sensor 58d includes a resonant circuit. In particular, the circuit can operate in a low-power configuration such that only startup characteristics including startup time or startup current can be used as a means to detect blink-induced changes in the resonant circuit response. In some embodiments, the resonant circuit includes an antenna 71 coupled to or forming part of loop 15 and a capacitor 72 located within or near the body of the device containing the electronics or microcontroller 22. In some embodiments, sensor 58d is an inductive capacitance (LC) sensor that changes its capacitance in response to physical movement of the eyelid 45 (i.e., a blink), resulting in an offset in its resonant frequency. The change in resonant frequency is captured and processed by integrated electronics, thereby providing an input signal related to eyelid movement.

[0030] In some embodiments, loop 15 forms an opening and has an inner diameter 15a generally in the range of between about 24 mm and about 30 mm (as Figure 3 shown). However, inner diameter 15a can be greater than 30 mm or less than about 24 mm. Generally, loop 15 contacts the ocular surface of the eye, and a portion of eye 35 extends through the opening of loop 15. As shown, the innermost surface of loop 15 is spaced a distance 73 from the limbal ring 60 of eye 35 (as Figure 3 shown) such that loop 15 or device 10 does not extend beyond the iris and / or limbal ring 60 of eye 35. Thus, neither the iris nor the limbal ring 60 is impeded by device 10. Generally, distance 73 varies with movement of eye 35. That is, even as eye 35 and the ocular surface move, loop 15 remains generally stationary. In some embodiments, the placement and / or movement of loop 15 is independent of the movement of eye 35. In some embodiments, loop 15 has a generally uniform cross-sectional shape and dimensions. However, in other embodiments, the cross-sectional shape of a portion of loop 15 is different from the cross-sectional shape of another portion of loop 15. Additionally, inner diameter 15a of loop 15 can vary independently of the outer diameter of loop 15.

[0031] In some embodiments and as Figure 5As shown, a portion of the gland stimulator assembly 20 and / or a portion of the sensor assembly 58 are disposed on the body of the polymeric substrate 66 to form the loop 15. The polymeric substrate 66 can consist of or include polymethyl methacrylate (“PMMA”), parylene, polyethylene terephthalate (“PET”), polyurethane, polyimide, rigid breathable fluorosilicone acrylate, liquid crystal polymer, silicone-based polymer, silicone acrylate. Generally, the polymeric substrate 66, the gland stimulator assembly 20, and the sensor assembly 58 are encapsulated in a soft, flexible biocompatible material 74 suitable for ocular wear, such as a polymeric material, such as PMMA, hydroxyethyl methacrylate (“polyHEMA”), silicone hydrogel, silicone-based polymer (e.g., fluorosilicacrylate), silicone elastomer, or a combination thereof. Generally, the device 10 is flexible enough to bend and be placed under the upper eyelid 45 and lower eyelid 50 of the user 40. Generally, the loop 15 forms a circular or annular shape with an uninterrupted circumference or perimeter. However, in some embodiments, a gap is formed within the loop 15 to form a C-shape. In some embodiments, the device 10 can have a visual marker on the device to assist the user when placing the device 10 on the eye such that the electrodes are oriented adjacent to the lacrimal gland.

[0032] Generally, the gland stimulator assembly 20 and the sensor assembly 58 are operatively coupled. Specifically, the sensor assembly 58 is operatively coupled to the microcontroller 22 of the gland stimulator assembly 20. In an example embodiment, any one or more portions or sub-assemblies of the gland stimulator assembly 20 and the sensor assembly 58 are operatively coupled. The device 10 can include any number of electrodes 21.

[0033] As Figure 3 and 4 shown, the microcontroller 22 is positioned between the sensors 58a and 58b such that the microcontroller 22 is positioned between the lower eyelid 50 and the eye 35. In some embodiments, the cross-section of the loop 15 associated with the microcontroller 22 is thicker or otherwise larger than other cross-sections of the loop 15. In some embodiments, the portion of the loop 15 associated with the microcontroller 22 provides a friction fit between the lower eyelid 50 and the eye 35 to anchor or position the loop 15 such that the electrodes 21 are close to or aligned with the gland 55.

[0034] In some embodiments, the power source 24 is a battery or the like. However, in some embodiments, the power source 24 is generated by the user or by the user's movement. For example, in some embodiments, the power source is energy obtained from the body of the user 40 (e.g., obtained from movement, temperature, both movement and temperature).

[0035] In some embodiments, and as Figure 5 and 6As shown, the antenna 71 is a loop antenna or a circular antenna formed within or otherwise coupled to the loop 15.

[0036] Reference Figure 6 (The lead assembly 23 is not shown). When viewed from the front view, the loop 15 is generally circular, having a vertex 15b associated with 0 degrees and an opposite bottom point 15c associated with 180 degrees. Two midpoints 15d and 15e between the top and bottom points 15b and 15c are associated with 90 degrees and 270 degrees, respectively. In some embodiments, the sensor 58a is positioned at or near the midpoint 15d and the sensor 58b is positioned at or near the midpoint 15e. Additionally, when the device 10 is designed to be placed in the right eye of the user 40, the microcontroller 22 is positioned at or near the bottom point 15c, where the electrode 21 is positioned at a location associated with between approximately 300 degrees and approximately 0 degrees between the midpoints 15e and 15b. In some embodiments, and when the device 10 is designed to be placed in the left eye of the user 40, the electrode 21 is positioned between approximately 0 degrees and approximately 60 degrees between the points 15b and 15d.

[0037] As Figure 7 shown, the device 10 is configured to be charged and / or cleaned by a remote device 80. Generally, the microcontroller 22 is configured to communicate wirelessly via a network 90 with the microcontroller 85 of the remote device 80. In some embodiments, the remote device 80 includes a microcontroller 85, a power source 95, a display 100, and chambers 105 and 110 formed in a housing 112. The wireless connection can be provided by the microcontrollers 22 and 85 or transceivers (not shown) coupled to each of the microcontrollers 22 and 85. In some embodiments, the remote device 80 is configured to temporarily accommodate the device 10 and a similar device 10'. In some embodiments, the devices 10 and 10' are respectively temporarily accommodated in the chambers 105 and 110 for cleaning the sensor assembly 58 and / or the gland stimulator assembly 20, for recharging the power source 24, such as via the power source 95, and / or for transferring data between the microcontroller 22 and the microcontroller 85. In some embodiments, the device 10 is associated with or configured for the right eye 35 of the user 40 and the device 10' is configured for the left eye of the user 40. In some embodiments, the microcontroller 22 is configured to communicate with another remote device 120 including a microcontroller 125, a power source 130, a display 135, and an alarm device 140. In some embodiments, the displays 135 and 100 are omitted. In some embodiments, the remote device 120 is a smart phone, a tablet computer, a personal digital assistant (PDA), or a personal computing device (PCD), etc. In some embodiments, the data exchanged between each of the devices 10 and 10' and the remote device 80 takes the form of any suitable technology, such as MICS, RF data, infrared, Near Field Communication (NFC), etc. In some embodiments, the exchanged data includes patient data or is related to patient data, such as, for example, a time model, an updated time model, external factors, and any other useful information for operating a closed-loop therapy system.

[0038] Figure 8 is a flowchart of a method 200 of operating a device 10 according to an example embodiment. Generally, method 200 includes monitoring the eye condition of a user 40 at step 205, determining whether to stimulate the lacrimal gland 55 at step 210, stimulating the lacrimal gland at step 215, storing patient data at step 220, predicting future dry eye symptoms at step 225, and generating an alarm at step 230 when the dry eye symptoms exceed a threshold. Figure 1-7

[0039] At step 205, and when the device 10 includes a sensor assembly 58, the device 10 detects the (one or more) eye conditions of the patient or user 40 via the sensor assembly 58. Generally, the sensor assembly 58 continuously monitors the (one or more) eye conditions of the user 40 to generate user eye condition data. In some embodiments, the sensor assembly 58 is used to detect a dry eye condition based on the user eye condition data, which includes: blink rate data generated by the sensor 58d; TFBU time data generated by the sensors 58a and 58b; and / or tear pH data generated by the sensor 58d. In some embodiments, the device 10 monitors all three parameters (i.e., blink rate, TFBU time, and tear pH), but in other embodiments, any change or combination of these three parameters is monitored continuously or periodically. In some embodiments, the user eye condition data forms part of the patient data stored in the microcontroller 22. In other embodiments and when the sensor assembly 58 is omitted from the device, the (one or more) eye conditions detected during step 205 may be detected by a remote device 120 or another device.

[0040] At step 210, the device 10 uses the user eye condition data (e.g., blink rate data, TFBU time data, and tear pH data) to determine whether to use the gland stimulator assembly 20 to stimulate the gland 55. As Figure 9 ​As shown, step 210 may include the following steps: receiving eye condition values monitored via user eye condition data, comparing these values with previous values, determining whether there is a threshold signal change to any metric, and then considering external factors such as local environmental factors, health factors, and personalization factors. When the monitored eye condition values are received, the microcontroller 22 compares the most recently received values with historical or previously received values. In some embodiments, the microcontroller 22 determines the difference between the most recently received value and the previous value. In some embodiments, the previous value is the value received within a specific time period (i.e., all previous values received in the last 2 hours), a specific number of the most recently received values (i.e., the most recently received 1000 values), and / or the highest / lowest value received (i.e., the highest blink rate associated with the user). In other embodiments, one of the previous values is a target value or baseline, and the difference is calculated for the target value. The difference may be an incremental difference based on the most recent value or may be a difference calculated based on the maximum, minimum, average, or target of the previously received values. After identifying the difference, the microcontroller 22 determines whether the difference exceeds a threshold. Generally speaking, if the difference does not exceed the threshold, then no stimulation is required. If the difference exceeds the threshold, then the microcontroller 22 continues to determine whether stimulation is required. In summary, sensors such as the sensor assembly 58 are used on or in the device 10 to provide closed-loop stimulation, which involves comparing measured values with expected values to determine whether and / or how to stimulate the lacrimal gland to produce tears.

[0041] When determining whether stimulation is required, the microcontroller 22 considers external factors, including environmental factors, health factors, and personalization factors of the user 40. Environmental factors include the time of day, season, weather, etc. Health factors include the medications taken by the user 40, the hormones of the user 40 (administered or measured within the user 40), and the sleep cycle of the user 40. Personalization factors include assuming whether the user 40 is learning, working, or performing another activity. In some embodiments, the microcontroller 22 considers external factors to determine whether exceeding the threshold indicates a true dry eye symptom or is contributed to by external factors. For example, if the blink rate exceeds the threshold indicating the presence of dry eye symptoms, but the user 40 is performing an activity that results in a higher blink rate, then the microcontroller 22 may determine that, in this case, the blink rate exceeding the threshold is not related to dry eye symptoms but to the activity of the user 40. Therefore, the microcontroller 22 uses external factors to perform a factor weighting analysis to determine whether the weighted difference exceeds the threshold and whether stimulation of the gland 55 is necessary or desired. However, in other embodiments and when the sensor assembly 58 is omitted from the device 10, step 210 includes referring to a time model stored in the memory 26 and / or wirelessly receiving instructions.

[0042] At step 215, device 10 stimulates gland 55 via electrode 21. During stimulation, lacrimal gland 55 produces tears mainly under the influence of the parasympathetic and sympathetic nerves. Electrical stimulation of the afferent and efferent nerves near lacrimal gland 55 can elicit a tear response. The efferent fibers synapse directly with the lacrimal gland acinar cells and trigger the release of water, electrolytes, and proteins from lacrimal gland 55 onto the ocular surface. In some embodiments, the gland stimulator assembly 20 emits 10 - 100 Hz, 100 - 500 μ pulses, with a charge density of 0.05 - 5.0 μC mm-2. The stimulation can be applied via a biphasic charge-balanced waveform. In some embodiments, the target stimulation parameters are adjusted based on several factors including the patient's own physiological and environmental variables to achieve an optimal response. In some embodiments and before stimulating gland 55 via electrode 21, the microcontroller calculates factor-weighted target stimulation parameters. That is, the microcontroller 22 considers external factors and historical patient data to determine the required stimulation intensity and duration. In some embodiments, the historical patient data includes the patient's response to historical gland stimulation. That is, the microcontroller 22 uses the sensor assembly 58 to monitor changes in the (one or more) eye conditions while stimulating the lacrimal gland 55 with previous target stimulation parameters. The changes in the (one or more) eye conditions detected in response to the stimulation with the previous target stimulation parameters form part of the historical patient data. Thus, device 10 is able to improve or update the previous target stimulation parameters based on the patient's response to the previous stimulation to determine the target stimulation parameters. Additionally, the microcontroller 22 considers external factors to determine the target stimulation parameters. That is, the microcontroller 22 not only uses external factors for factor-weighted analysis to determine whether stimulation is needed, but also uses external factors for factor-weighted analysis to determine the target stimulation parameters of the required stimulation. In some embodiments, before, during, or after stimulating gland 55, the microcontroller 22 stores the target stimulation parameters and / or updates the time model using the target stimulation parameters.

[0043] Figure 10 Illustrates a closed-loop dry eye control system managed by device 10 during steps 205, 210, and 215. As shown, DryEye(t) base is the patient-specific target tear hydration baseline. DryEye actual is the real-time dry eye condition measured by the sensor assembly 58. In this embodiment, the microcontroller 22, which in some embodiments includes or is a proportional-integral-derivative ("PID") controller, first detects DryEye actual via the monitoring data from the sensor assembly 58 and adjusts the stimulation applied by electrode 21 in relation to DryEye(t) baseThe amount of lacrimal duct stimulation is proportional to the magnitude and direction of the deviation error. For example, the microcontroller 22 can be compared with patient data recorded over the past 24 hours or a month. In some embodiments, for example, the microcontroller 22 is compared with patient data recorded over the past 24 hours.

[0044] At step 220, patient data including monitoring data, target stimulation parameters, previous target stimulation parameters, and external factor data (measured, assumed, or received by the user 40) is stored. As described above, in some embodiments, the user / patient data is stored in the microcontroller 22. However, the user / patient data is also stored or received by the microcontroller 85 of the remote device 80 via the network 90 and / or stored or received by the microcontroller 125 of the remote device 120 via the network 90. As Figure 7 shown, during standard device disinfection or charging times (e.g., weekly or monthly), the microcontroller 22 can upload and update user / patient data (which may span months to years) to a cloud-based database via the microcontroller 85 and / or the microcontroller 125. This user / patient data can be used to update, customize, and generate predictive models to improve dry eye management over a period of hours to days. The models can include various factors used to generate the predictive models, including historical, current, and expected or predicted external factors. Thus, on-board prediction allows for the optimization of patient treatment regimens or timing models based on each patient's specific physiology. These metrics can include patient-specific parameters such as, for example, age, comorbidities, diabetes, hormonal changes (pregnancy, use of contraception, and hormone replacement therapy), allergies, blink rate, tear production rate, etc. In some embodiments, the metrics also include monitored medications and dosages (e.g., antihypertensive medications (diuretics and beta blockers), sleeping pills, antidepressants, anti-anxiety medications, pain medications, antihistamines, and decongestants, as well as some medications used to treat acne and Parkinson's disease). In some embodiments, the metrics also include environmental factors such as, for example, a dry indoor environment; air conditioning or heating; a hospital environment; an airplane; other work environments; wind; smoke; fumes from chemicals; and sunlight. When used with the predictive models, patient metrics and patient data are used to create and provide customized treatments for each patient while addressing symptoms and compliance, which generally improves the outcomes for DED patients.

[0045] In some embodiments, the remote device 120 requests confirmation that a value classified as a dry eye symptom is consistent with the dry eye symptom. The confirmation request can be displayed on the display 135 of the remote device 120. The user 40 of the remote device 120 can provide confirmation via an input button located on the remote device 120. In some embodiments, a patient profile including user / patient data and a customized treatment plan for the user 40 is stored in one or more of the microcontrollers 22, 85, and / or 125 such that the patient profile is refined each time the device 10 is used by the user 40. In some cases, and when the device 10 is disposable or has a limited design life, the patient profile is stored in the microcontroller 85 or 125, and when a new device similar to the device 10 is paired with the remote device 80 or 120, the patient profile can be uploaded or transferred to the new device.

[0046] At step 225, the microcontroller 22 predicts future dry eye symptoms. Using historical user data and the patient profile, the microcontroller 22 identifies trends in values to predict upcoming untreatable dry eye symptoms that may exceed the treatment capabilities of the device 10. In some embodiments, the device 10 monitors the duration and frequency of values classified as dry eye symptoms and that are also treated or corrected via stimulation of the gland 55. The device 10 and / or the remote device 120 also determine whether the duration of the detected dry eye symptom is greater than a predetermined maximum duration. For example, a dry eye symptom that persists for more than 2 hours (or another predetermined duration associated with potential damage to the eye 35) can be classified as a detected untreatable dry eye symptom that requires intervention by the user 40.

[0047] At step 230 and in some embodiments, the remote device 120 generates an alert. Generally, the alert is in response to the device 10 or the remote device 120 predicting and / or detecting an untreatable dry eye symptom. In some embodiments, the remote device 120 generates different types of alerts, such as, for example, a predicted or detected untreatable dry eye symptom warning. Additionally, a first recommendation can also be generated. For example, the first recommendation can be to administer eye drops to avoid potential damage to the eye 35, change environmental conditions, change activities, etc. The recommendation includes an audible recommendation via a speaker (e.g., the alert device 140) of the remote device 120 and / or a written message displayed on the display 135 of the remote device 120. In some embodiments, in the absence of the remote device 120, the device 10 generates the alert. For example, the device 10 can include a light-emitting diode that is activated to generate an alert, the device 10 can provide a vibration alert, or the device 10 can provide an electrical pulse that creates a physical sensation on the eye 35.

[0048] Although in some embodiments, the device 10 communicates with the remote device 80 and / or the remote device 120 when the device 10 is removed from the periorbital space, in other embodiments, the power supply 24 is recharged when the user 40 wears the device 10. For example, the power supply 24 can be charged by a power supply located within a pair of glasses, a hat, or headphones that can charge the power supply 24 when worn by the user 40. In other embodiments, the device 10 communicates with the remote device 80 and / or the remote device 120 when the user 40 wears the device 10. In these cases, and when the remote device 120 is a phone or other mobile electronic device associated with the user 40, the GPS data of the remote device 120 as well as the user 40 is transmitted to the microcontroller 22. In some embodiments, the microcontroller 22 regards the real-time location via the GPS data of the user 40 as an external factor. In some embodiments, the data received and monitored by the remote device 120 is transmitted to the microcontroller 22 and is one of the external factors. In other embodiments, the microcontroller 125 considers the GPS data when determining / updating the patient profile and then uploads it to the device 10. However, other types of location information, such as means based on calendar events, cellular triangulation, WIFI sources, user input, etc., can be considered by the microcontroller 125 and uploaded to the device.

[0049] In some embodiments, the electrodes 21 are spaced between the midpoints 15d and 15e such that the point 15b is positioned between the electrodes 21. In some cases, the electrodes 21 are spaced around the entire circumference of the ring 15. In some embodiments, the microcontroller 22 determines whether the device 10 is located in the right eye or the left eye by selectively stimulating portions of the electrodes 21 and selectively activates the portions of the electrodes 21 that have been determined to be close to the lacrimal gland 55. Thus, one design of the device 10 can be used for either eye of the user 40.

[0050] In some embodiments, device 10 and / or method 200 respond to a patient's current physiological state and provide optimal therapeutic stimulation of the lacrimal gland 55. In some embodiments, when the limbal ring 60 and the iris 35 of the eye extend through and beyond the opening of the ring 15, device 10 and / or method 200 do not block or affect vision in any way. In some embodiments, device 10 and / or method 200 are compatible with all forms of vision correction (e.g., contact lenses, glasses, etc.). In some embodiments, device 10 and / or method 200 generate data for an improved outcomes-based care model. In some embodiments, device 10 and / or method 200 target the stimulation of the lacrimal gland 55 both temporally and spatially. In some embodiments, device 10 and / or method 200 can be used to implement a fully customizable stimulation paradigm from a first-order constant stimulation curve to on-demand pulsatile stimulation. Factors considered by device 10 and / or method 200 include circadian rhythm, seasonality, behavior, and slowly varying variables that are not currently being considered in any useful way in the management of dry eye disease. In some embodiments, device 10 and / or method 200 provide a walk-around hands-free and automated operation that is invisible to the patient and others. In some embodiments, device 10 and / or method 200 discreetly monitors and treats dry eye disease without the need for tethering or any additional body-worn hardware. Generally, device 10 allows for integrated dry eye sensing, integration, hands-free electronic lacrimal gland stimulation, and closed-loop operation based on patient-specific physiological parameters and personalized environmental and health factors.

[0051] In other embodiments, the microcontroller 125 is a battery-powered hub with a processor. In other embodiments, the microcontroller 125 is omitted or replaced with a remote server (e.g., "the cloud"). Additionally, in some embodiments, device 10 is at least capable of communicating with an application server. In some embodiments, a mobile application is stored in the memory of the microcontroller 125 and selectively displayed on the display 135 of the remote device 120, and / or in the memory and selectively displayed on the display 100 of the remote device 80. The mobile application communicates with the application server via the network 90. The application server receives user data and / or a summary thereof directly from device 10 via the network 90 through the application server. In some embodiments, the application server predicts / detects potential dry eye symptoms exceeding a maximum threshold amount and sends an instruction to generate an alert to the remote device 120. In some embodiments, the alert includes a push notification displayed on the display 135 of the remote device 120. Thus, while the collection of user data is performed at device 10, there are multiple locations where the prediction / detection can occur, such as, for example, in the microcontroller 125 of the remote device 120, in the microcontroller 22, or in the remote server.

[0052] In some embodiments, measurements and combinations of measurements classified as indicators of dry eye symptoms are improved based on the aggregation of data from multiple users, where the data has been received at a remote server. That is, in some embodiments, data from multiple users can be used to improve the factor-weighted analysis performed by microcontrollers 22, 85, and / or 125.

[0053] In some embodiments, devices 10, remote device 80, and / or remote device 120 are configured to operate in a sleep or idle mode.

[0054] In some embodiments and as described above, sensor assembly 58 is omitted from device 10 and microcontroller 22 activates electrode 21 based on a predetermined schedule stored in device 10, regardless of the eye condition. In some embodiments, sensor assembly 58 is omitted from device 10 and microcontroller 22 activates electrode 21 in response to a wireless transmission or command from remote device 120. That is, remote device 120 can monitor the condition and wirelessly instruct microcontroller 22 to activate electrode 21. Thus and in some embodiments, remote device 120 includes a sensor assembly, such as a camera, which measures the user's eye condition. For example, and when the user is looking at remote device 120, remote device 120 detects a blink rate indicative of a dry eye condition and remote device 120 instructs microcontroller 22 to activate electrode 21.

[0055] Generally, any creation, storage, processing, and / or exchange of user data associated with the methods, devices, and / or systems disclosed herein is configured to comply with various privacy settings and security protocols as well as prevalent data regulations, to comply with the confidentiality of processing and the integrity of user data, as a matter of importance. For example, the device and / or system can include modules that implement information security controls to comply with multiple standards and / or other protocols. In some embodiments, the module receives privacy setting selections from the user and implements controls to comply with the selected privacy settings. In other embodiments, the module identifies data considered sensitive, encrypts the data according to any suitable and well-known method in the art, replaces sensitive data with codes to pseudonymize the data, and otherwise ensures compliance with the selected privacy settings and data security requirements and regulations.

[0056] In an example embodiment, network 90 includes the Internet, one or more local area networks, Bluetooth Low Energy networks, one or more wide area networks, one or more cellular networks, one or more wireless networks, one or more voice networks, one or more data networks, one or more communication systems, and / or any combination thereof.

[0057] In some embodiments, device 10 automatically, dynamically, and predictively adjusts the treatment level of DED treatment over the course of a day / week / month based on real-time measurements of the patient's dry eye physiology affected by the personalized environment and health factors. By integrating electronics into the periorbital-mounted device 10, a patient-specific therapy is customized by directly measuring physiological metrics such as blink rate, tear film break-up time, and tear pH monitored by sensor assembly 58. In some embodiments, sensor assembly 58 includes, in addition to serving as alternatives to sensors 58a, 58b, 58c, and 58d, one or more thermal sensors that monitor the temperature of the ocular surface, one or more sensors that monitor meibomian lipid content (i.e., the oil that prevents rapid evaporation of tears), and / or one or more sensors that monitor corneal and conjunctival inflammation biomarkers.

[0058] In an example embodiment, as Figure 11 shown and continuing to refer to Figure 1-10 , an illustrative node 1000 for implementing one or more of the example embodiments described above and / or Figure 1-10 shown therein is depicted. Node 1000 includes a microprocessor 1000a, an input device 1000b, a storage device 1000c, a video controller 1000d, a system memory 1000e, a display 1000f, and a communication device 1000g, all of which are interconnected by one or more buses 1000h. In several example embodiments, storage device 1000c may include a hard disk drive, a CD-ROM, an optical drive, any other form of storage device, and / or any combination thereof. In several example embodiments, storage device 1000c may include and / or be capable of accommodating a CD-ROM, a DVD-ROM, or any other form of computer-readable medium that may contain executable instructions. In several example embodiments, communication device 1000g may include a modem, a network card, or any other device to enable the node to communicate with other nodes. In several example embodiments, any node represents a plurality of interconnected (either via an intranet or the Internet) computer systems, including but not limited to personal computers, mainframes, PDAs, smartphones, and cellular phones.

[0059] In several example embodiments, one or more components of the system described above and / or Figure 1-10 shown therein at least include node 1000 and / or its components, and / or one or more nodes that are substantially similar to node 1000 and / or its components.

[0060] In several example embodiments, the above and / or Figure 1-10One or more of the applications, systems, and applications shown include a computer program that includes multiple instructions, data, and / or any combination thereof; applications written in, for example, Arena, Hypertext Markup Language (HTML), Cascading Style Sheets (CSS), JavaScript, Extensible Markup Language (XML), Asynchronous JavaScript and XML (Ajax), and / or any combination thereof; web-based applications written in, for example, Java or Adobe Flex, which, in several example embodiments, extract real-time information from one or more servers and automatically refresh the latest information at predetermined time increments; or any combination thereof.

[0061] In several example embodiments, a computer system generally includes at least hardware capable of executing machine-readable instructions, as well as software (usually machine-readable instructions) for performing actions that produce a desired result. In several example embodiments, a computer system can include a mixture of hardware and software, as well as computer subsystems.

[0062] In several example embodiments, the hardware generally includes at least a platform with processor capabilities, such as a client machine (also known as a personal computer or server) and a handheld processing device (such as, for example, a smartphone, tablet computer, personal digital assistant (PDA), or personal computing device (PCD)). In several example embodiments, the hardware can include any physical device capable of storing machine-readable instructions, such as a memory or other data storage device. In several example embodiments, other forms of hardware include, for example, hardware subsystems, including transmission devices such as modems, modem cards, ports, and port cards.

[0063] In several example embodiments, the software includes any machine code stored in any memory medium such as RAM or ROM, as well as machine code stored on other devices such as, for example, flash memory or a CD ROM. In several example embodiments, the software can include source code or object code. In several example embodiments, the software includes any set of instructions capable of being executed on a node, such as, for example, on a client machine or server.

[0064] In several example embodiments, a combination of software and hardware can also be used to provide enhanced functionality and performance for certain embodiments of the present disclosure. In an example embodiment, software functionality can be directly fabricated into a silicon chip. Therefore, it should be understood that a combination of hardware and software is also included within the definition of a computer system and is thus contemplated by the present disclosure as a possible equivalent structure and equivalent method.

[0065] In several example embodiments, a computer-readable medium includes, for example, a passive data storage device such as random access memory (RAM) and a semi-permanent data storage device such as a compact disc read-only memory (CD-ROM). One or more example embodiments of the present disclosure may be implemented in the RAM of a computer to transform a standard computer into a new specific computing machine. In several example embodiments, a data structure is a data organization that can implement an embodiment of the present disclosure. In an example embodiment, a data structure may provide an organization of data or an organization of executable code.

[0066] In several example embodiments, any network and / or one or more of its parts may be designed to work on any particular architecture. In an example embodiment, one or more parts of any network may execute on a single computer, a local area network, a client-server network, a wide area network, the Internet, handheld and other portable and wireless devices and networks.

[0067] In several example embodiments, a database may be any standard or proprietary database software. In several example embodiments, a database may have fields, records, data, and other database elements that may be associated by database-specific software. In several example embodiments, data may be mapped. In several example embodiments, mapping is a process of associating one data entry with another data entry. In an example embodiment, data contained in the location of a character file may be mapped to a field in a second table. In several example embodiments, there is no limitation on the physical location of a database, and a database may be distributed. In an example embodiment, a database may exist remote from a server and operate on a separate platform. In an example embodiment, a database may be accessible via the Internet. In several example embodiments, more than one database may be implemented.

[0068] In several example embodiments, multiple instructions stored on a non-transitory computer-readable medium may be executed by one or more processors to cause the one or more processors to perform or implement all or part of the above operations of each of the above example embodiments of the system, method, and / or any combination thereof. In several example embodiments, such processors may include one or more of a microprocessor 1000a, any processor(s) as part of a system component, and / or any combination thereof, and such computer-readable medium may be distributed among one or more components of the system. In several example embodiments, such a processor may execute multiple instructions in conjunction with a virtual computer system. In several example embodiments, such multiple instructions may communicate directly with one or more processors and / or may interact with one or more operating systems, middleware, firmware, other applications, and / or any combination thereof to cause the one or more processors to execute the instructions.

[0069] Disclosed is a method of stimulating a user's lacrimal gland using a periorbital component, the method comprising positioning the periorbital component between the user's eyelids and eyes; wherein the periorbital component comprises: a ring configured to be worn on the user's eye; a plurality of electrodes spaced along the ring; a microcontroller; a lead assembly extending along at least a portion of the ring; wherein the lead assembly extends between the microcontroller and the plurality of electrodes to operably connect the plurality of electrodes to the microcontroller; and a sensor assembly coupled to the ring and operably coupled to the microcontroller and the plurality of electrodes; monitoring one or more eye conditions using the sensor assembly; determining, based on the monitored one or more eye conditions and using the microcontroller, whether the monitored one or more eye conditions exceed a predetermined threshold; and stimulating the user's lacrimal gland using the microcontroller and the plurality of electrodes in response to the monitored one or more eye conditions exceeding the predetermined threshold. In one embodiment, the method further comprises storing the historically monitored one or more eye conditions in the microcontroller; wherein determining, based on the monitored one or more eye conditions and using the microcontroller, whether the monitored one or more eye conditions exceed a predetermined threshold comprises comparing the monitored one or more eye conditions with the historically monitored one or more eye conditions. In one embodiment, the method further comprises storing external factors in the microcontroller; herein, external factors include any one or more of the following: data associated with health factors associated with the user; data associated with environmental factors associated with the user's local environment, and activity data associated with activities performed by the user; and wherein determining whether the monitored one or more eye conditions exceed a predetermined threshold is also based on external factors. In one embodiment, the method further comprises the microcontroller wirelessly receiving external factors from another microcontroller spaced apart from the periorbital component. In one embodiment, the method further comprises storing one or more target eye conditions in the microcontroller; using the microcontroller to compare the one or more target eye conditions with the monitored one or more eye conditions to determine a difference; and determining target stimulation parameters based on the difference; and wherein the lacrimal gland is stimulated using the microcontroller, the plurality of electrodes, and the target stimulation parameters. In one embodiment, the method further comprises monitoring a change in the one or more eye conditions using the sensor assembly while stimulating the lacrimal gland using the target stimulation parameters; and updating the target stimulation parameters in response to the change in the one or more eye conditions. In one embodiment, the sensor assembly comprises one or more of a first sensor, a second sensor, a third sensor, and a fourth sensor; wherein each of the first sensor and the second sensor is an electrode for measuring the resistivity of the user's tears; wherein the third sensor comprises a microelectrode pH sensor for measuring the pH level of the tears; and wherein the fourth sensor comprises a resonant circuit for measuring the user's blink rate. In one embodiment, the sensor assembly comprises a fourth sensor; and wherein the fourth sensor comprises an induction loop and a capacitor.In one embodiment, the induction loop and capacitor detect movement of a user's eyelid. In one embodiment, the loop has an opening defining a most inner diameter; and a portion of the eye passes through the opening of the loop. In one embodiment, the most inner diameter is greater than the diameter of the limbal ring.

[0070] Disclosed is a device configured to be worn on a user's eyes and configured to surround the eye rim, the device including a lacrimal gland stimulator assembly, wherein the stimulator assembly includes: a plurality of electrodes spaced along the device; a microcontroller; and a lead assembly extending along at least a portion of the device; wherein the lead assembly extends between the microcontroller and the plurality of electrodes to operably couple the plurality of electrodes to the microcontroller; and a sensor assembly operably coupled to the stimulator assembly; wherein the microcontroller is configured to: receive from the sensor assembly one or more eye condition data related to the monitored one or more eye conditions; determine whether the monitored one or more eye conditions exceed a predetermined threshold based on the one or more eye condition data and a user profile; and use the lacrimal gland stimulator assembly and in response to the monitored one or more eye conditions exceeding the predetermined threshold to stimulate the user's lacrimal gland. In one embodiment, the microcontroller is configured to store a user profile, wherein the user profile includes historically monitored one or more eye conditions; and the microcontroller is further configured to compare the monitored one or more eye conditions with the historically monitored one or more eye conditions when determining whether the monitored one or more eye conditions exceed the predetermined threshold. In one embodiment, the microcontroller is configured to store a user profile, wherein the user profile includes external factors associated with the user; the external factors include any one or more of the following: data associated with health factors associated with the user; data associated with environmental factors associated with the user's local environment, and activity data associated with activities performed by the user; and wherein the microcontroller is further configured to perform a factor weighted analysis using the external factors and the monitored one or more eye conditions when determining whether the monitored one or more eye conditions exceed the predetermined threshold. In one embodiment, the microcontroller is further configured to: store in the microcontroller one or more target eye conditions; use the microcontroller to compare the one or more target eye conditions with the monitored one or more eye conditions to determine a difference; and determine target stimulation parameters based on the difference; and wherein the lacrimal gland is stimulated using the stimulator and the target stimulation parameters. In one embodiment, the microcontroller is further configured to: monitor a change in the one or more eye conditions using the sensor assembly while stimulating the lacrimal gland using the target stimulation parameters; and update the target stimulation parameters in response to the change in the one or more eye conditions. In one embodiment, the sensor assembly includes one or more of a first sensor, a second sensor, a third sensor, and a fourth sensor; wherein each of the first sensor and the second sensor is an electrode for measuring the resistivity of the user's tear fluid; wherein the third sensor includes a microelectrode pH sensor for measuring the pH level of the tear fluid; and wherein the fourth sensor includes a resonant circuit for measuring the user's blink rate. In one embodiment, the device is configured as a periorbital ring.

[0071] Disclosed is a dry eye treatment device, which includes a ring forming an opening, wherein when the ring is positioned on a user's eye, a part of the eye extends through the opening of the ring; a first microcontroller, which is coupled to the ring and communicates wirelessly with a second microcontroller, and the second microcontroller is spaced apart from the first microcontroller; a sensor assembly, which is coupled to the ring and operably coupled to the first microcontroller; wherein the sensor assembly is configured to monitor one or more eye conditions of the eye; a lacrimal gland stimulator assembly is coupled to the ring and operably coupled to the first microcontroller; wherein the first microcontroller is configured to: store one or more target eye conditions associated with the user's eye; receive external data associated with the user from the second microcontroller, wherein the external data includes environmental factors associated with the user, health factors associated with the user, and the user's activities; receive data about one or more eye conditions of the eye from the sensor assembly; compare the received data about one or more eye conditions with the one or more target eye conditions to determine a difference; determine whether to stimulate the user's lacrimal gland based on the difference and the external data; and stimulate the user's lacrimal gland using the lacrimal gland stimulator assembly. In one embodiment, the sensor assembly includes one or more of a first sensor, a second sensor, a third sensor, and a fourth sensor; wherein each of the first sensor and the second sensor is an electrode for measuring the resistivity of the user's tear fluid; wherein the third sensor includes a microelectrode pH sensor for measuring the pH level of the tear fluid; and wherein the fourth sensor includes a resonant circuit for measuring the user's blink rate. In one embodiment, the first microcontroller is further configured to determine target stimulation parameters based on the difference and the external data; and wherein the first microcontroller stimulates the lacrimal gland using the target stimulation parameters. In one embodiment, the first microcontroller is further configured to generate a prediction model related to the predicted future eye condition of the user based on the external data and the received data about one or more eye conditions. In one embodiment, wherein the second microcontroller is further configured to generate a prediction model related to the predicted future eye condition of the user based on the external data and the received data about one or more eye conditions, and wirelessly transmit the prediction model to the first microcontroller.

[0072] It should be understood that changes may be made to the foregoing without departing from the scope of the present disclosure.

[0073] In several example embodiments, the elements and teachings of various illustrative example embodiments may be combined in whole or in part in some or all of the illustrative example embodiments. Additionally, one or more elements and teachings of various illustrative example embodiments may be at least partially omitted, and / or at least partially combined with one or more other elements and teachings of various illustrative example embodiments.

[0074] Any spatial references, such as, for example, "upper", "lower", "above", "below", "between", "bottom", "vertical", "horizontal", "angle", "upward", "downward", "side-to-side", "left-to-right", "right-to-left", "top-to-bottom", "bottom-to-top", "on", "off", "from bottom to top", "from top to bottom", etc. are for illustrative purposes only and do not limit the specific orientation or position of the above-described structures.

[0075] In several example embodiments, although different steps, processes, and procedures are described as performing different actions, one or more steps, one or more processes, and / or one or more procedures may also be performed in a different order, concurrently, and / or sequentially. In several example embodiments, these steps, processes, and / or procedures may be combined into one or more steps, processes, and / or procedures.

[0076] In several example embodiments, one or more operating steps in each embodiment may be omitted. Additionally, in some cases, some features of the present disclosure may be employed without the corresponding use of other features. Further, one or more of the above-described embodiments and / or variations may be combined in whole or in part with any one or more of the other above-described embodiments and / or variations.

[0077] Although several example embodiments have been described in detail above, the described embodiments are merely examples and not restrictive, and those skilled in the art will readily understand that many other modifications, changes, and / or substitutions are possible without materially departing from the novel teachings and advantages of the present disclosure. Accordingly, all such modifications, changes, and / or substitutions are intended to be included within the scope of the present disclosure as defined by the following claims. In the claims, any means-plus-function clause is intended to cover the structures described herein as performing the recited function, and not only structural equivalents but also equivalent structures. Additionally, the applicant expressly disclaims any reliance on 35 U.S.C.§112(f) for any limitation of any claim herein, except for any limitation expressly using the word "means" and the associated function.

Claims

1. An orbital ring with an opening, the orbital ring being configured to be worn on a user's eye and configured to surround the limbus of the eye, wherein when the orbital ring is worn on the user's eye, a portion of the eye extends through the opening of the orbital ring and the orbital ring does not extend above the limbus, the orbital ring comprises: A lacrimal gland stimulator assembly, wherein the stimulator assembly comprises: A plurality of electrodes spaced along the orbital ring; A microcontroller; and A lead assembly extending along at least a portion of the orbital ring; wherein the lead assembly extends between the microcontroller and the plurality of electrodes to operably couple the plurality of electrodes to the microcontroller; and A sensor assembly operably coupled to the stimulator assembly, wherein the sensor assembly comprises at least one sensor located on the outer periphery of the orbital ring; wherein the microcontroller is configured to: Receive from the sensor assembly one or more eye condition data related to one or more monitored eye conditions; Determine whether the one or more monitored eye conditions exceed a predetermined threshold based on the one or more eye condition data and a user profile; and Use the microcontroller and in response to the one or more monitored eye conditions exceeding the predetermined threshold, activate the plurality of electrodes to stimulate the user's lacrimal gland.

2. The orbital ring according to claim 1, wherein the microcontroller is configured to store the user profile, wherein the user profile includes one or more historically monitored eye conditions; and wherein the microcontroller is further configured to compare the one or more monitored eye conditions with the one or more historically monitored eye conditions when determining whether the one or more monitored eye conditions exceed the predetermined threshold.

3. The orbital ring according to claim 1, wherein the microcontroller is configured to store the user profile, wherein the user profile includes external factors associated with the user; wherein the external factors include any one or more of the following: Data associated with health factors associated with the user; Data associated with environmental factors associated with the user's local environment, and Activity data associated with activities performed by the user; and wherein the microcontroller is further configured to perform a factor weighting analysis using the external factors and the one or more monitored eye conditions when determining whether the one or more monitored eye conditions exceed the predetermined threshold.

4. The orbital ring according to claim 1, wherein the microcontroller is further configured to: Store one or more target eye conditions in the microcontroller; Use the microcontroller to compare the one or more target eye conditions with the one or more monitored eye conditions to determine a difference; and Determine target stimulation parameters based on the difference; and wherein the plurality of electrodes are activated based on the target stimulation parameters.

5. The orbital ring according to claim 4, wherein the microcontroller is further configured to: After activating the plurality of electrodes using the target stimulation parameters, monitor changes in the one or more eye conditions using the sensor assembly; and Update the target stimulation parameters in response to changes in the one or more eye conditions.

6. The periorbital ring according to claim 1, wherein the at least one sensor includes one or more of a first sensor, a second sensor, a third sensor, and a fourth sensor; wherein each of the first sensor and the second sensor is an electrode that measures the resistivity of the user's tear fluid; wherein the third sensor includes a microelectrode pH sensor that measures the pH level of the tear fluid; and wherein the fourth sensor includes a resonant circuit that measures the user's blink rate.

7. The periorbital ring according to claim 1, wherein the periorbital ring forms a continuously circular circumference.

8. The periorbital ring according to claim 1, wherein the at least one sensor includes a first sensor and a second sensor, wherein each of the first sensor and the second sensor is an electrode configured to measure the resistivity of the tear fluid located between the sensors; and wherein the first sensor and the second sensor are located on the outer periphery of the periorbital ring.

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