Ophthalmic devices, systems, and methods for treating dry eye

Abstract

In some aspects, an electronic contact lens for treating dry eye is presented. According to some aspects, the electronic contact lens includes a concave surface configured to conform to a patient's eye, a sensor configured to generate a signal indicative of eyelid movement, and at least one capacitor configured to store energy for stimulating the eye. The electronic contact lens can also include at least two electrodes coupled to the at least one capacitor, where the at least two electrodes are exposed to the concave surface and configured to deliver power from the at least one capacitor to stimulate the eye. The electronic contact lens further includes a processor coupled to the sensor and the electrodes. The processor can be configured to calculate a blink rate from the sensor output and activate the at least two electrodes to stimulate the eye based on the blink rate.

Description

[0001] Cross-reference to related applications

[0002] This application claims priority and interest in U.S. Provisional Application No. 63 / 060,363, filed August 3, 2020, and U.S. Application No. 17 / 391,835, filed August 2, 2021, each of which is incorporated in its entirety by reference. Technical Field

[0003] This disclosure generally relates to ophthalmic devices for treating dry eye syndrome, and specifically, but not exclusively, to smart contact lenses for treating dry eye syndrome by stimulating the surface of the eye. Background Technology

[0004] The term "dry eye syndrome" caused by contact lens wear is broad and encompassing, as the underlying causes of dry eyes due to contact lens wear are multifaceted. Many researchers have attempted to address dry eye syndrome through innovations in contact lens materials, such as increasing oxygen permeability, increasing the water content of hydrogels, altering polymer formulations, and applying different surface coatings. In some cases, attempts to incorporate more water into hydrogels have increased eye dryness due to the difference in fluid concentration between the liquid and the eye.

[0005] In many cases, the most comfortable eye environment for contact lens wearers with dry eye syndrome (aside from not wearing lenses at all) is when their eyes are closed, the eyelids return to a warm environment, and the tear film concentration level decreases due to evaporation.

[0006] The pathway of basal tear production is understood to be primarily a closed-loop thermal system. Studies have shown that if a temperature difference is detected on the cornea due to the natural evaporation of the tear film, the lacrimal glands produce tears to restore thermal balance between the tear film and corneal temperature receptors. However, if dryness is sufficient to cause mechanical discomfort, but the lens still maintains a warm environment (not triggering basal tear production), then dry eye syndrome can worsen. Therefore, people with mild dry eye syndrome may dislike wearing contact lenses because they may exacerbate or worsen their condition.

[0007] Symptoms can be temporarily relieved by topical application of liquid medications, such as various forms of eye drops. However, the temporary nature of the relief necessitates repeated use of the drops, which can be both expensive and inconvenient.

[0008] Therefore, there is still a need for devices and / or technologies to treat dry eye in contact lens wearers. Summary of the Invention

[0009] Systems, devices, and methods for treating dry eye syndrome have been proposed. In some aspects, an electronic contact lens for treating dry eye syndrome is provided. According to some aspects, the electronic contact lens includes a concave surface configured to conform to a patient's eye, a sensor configured to generate signals indicative of eyelid movement, and at least one capacitor configured to store energy for stimulating the eye. The electronic contact lens may further include at least two electrodes coupled to the at least one capacitor, wherein the at least two electrodes are exposed on the concave surface and configured to deliver power from the at least one capacitor to stimulate the eye. According to some aspects, the electronic contact lens also includes a processor coupled to the sensor and the electrodes. The processor is configured to receive signals from the sensor, determine when a blink occurs based on the signals, calculate a blink rate from a set of two or more detected blinks, and activate the at least two electrodes based on the blink rate to stimulate the eye using a first stimulation amplitude.

[0010] In some aspects, this disclosure describes a method for using a smart contact lens on a user's eye. The smart contact lens includes a sensor configured to generate signals indicative of eyelid movement in the user, and at least two electrodes configured to stimulate the eye. The method of using the smart contact lens includes determining when a blink occurs based on signal repetition to generate a set of at least two detected blinks, calculating a blink rate from the at least two detected blinks, and determining, based on the blink rate, whether to activate at least two electrodes to stimulate the eye.

[0011] In some aspects, this disclosure describes an ophthalmic device configured to conform to a user's eye and overlap with the cornea. The ophthalmic device includes a sensor configured to generate a signal indicative of blinking of the user's eyelids, at least two electrodes configured to stimulate the eye, and a processor coupled to the sensor and electrodes. The processor is configured to receive the signal from the sensor, estimate when a blink occurs based on the signal, calculate a blink rate from a set of two or more detected blinks, and activate at least two electrodes based on the blink rate to adequately stimulate the eye to generate a blink reflex.

[0012] Additional aspects, features, and advantages of this disclosure will become clear from the following detailed description. Attached Figure Description

[0013] Exemplary embodiments of this disclosure will be described with reference to the accompanying drawings, in which:

[0014] Figure 1 This is a block diagram of a smart contact lens according to one embodiment.

[0015] Figure 2 This is a block diagram of a sensor for a contact lens according to one embodiment.

[0016] Figure 3A This is a frontal / eyelid / frontal view of a contact lens according to one embodiment, and Figure 3B This is a view of the back / facing the cornea / posterior side of the contact lens. Figure 3C This is used in the user's eye according to one embodiment. Figure 3A and 3B A view of the contact lenses.

[0017] Figure 4 The illustration depicts a method of operating a contact lens, such as the contact lens described herein, according to one embodiment.

[0018] Figure 5A and 5B The illustration shows an ophthalmic device deployed on a user's eye at different locations on the eyelid, according to one embodiment. Detailed Implementation

[0019] To facilitate understanding of the principles of this disclosure, reference is now made to the embodiments illustrated in the accompanying drawings, which are described using specific language. However, it should be understood that this is not intended to limit the scope of this disclosure. Any changes and further modifications to the described devices, systems, and methods, as well as any further applications of the principles of this disclosure, are fully contemplated and included within this disclosure, as would normally occur to those skilled in the art related to this disclosure. In particular, it is fully contemplated that features, components, and / or steps described with respect to one embodiment can be combined with features, components, and / or steps described with respect to other embodiments of this disclosure. However, for the sake of brevity, multiple iterations of these combinations will not be described separately.

[0020] The devices and methods described herein attempt to supplement basal tear production with reflexive tearing (which can be hindered by contact lens wear or pre-existing mild dry eye). In some embodiments, reflexive tearing is stimulated by neural stimulation of the eyeball (e.g., cornea or sclera) that generates reflexive tearing via the lacrimal glands, in the form of contact lenses stimulating afferent neurons on the eyeball.

[0021] The shape factor of contact lenses maintains refractive correction of vision and can also track blink rate, blink pattern, and / or blink detection, allowing algorithms to determine when and how often to stimulate the cornea. By detecting blinks quickly enough, stimulation can also be synchronized during blinks, resulting in a more natural and user-friendly stimulus.

[0022] For many, dry eye syndrome is exacerbated by a low blink rate. This is especially problematic for young gamers or hyper-connected individuals who forget to blink while playing video games or working. Therefore, it is possible to increase the intensity of stimulation (within safe limits, of course) so that contact lenses can also function as “blink pacemakers,” providing sufficient stimulation to suggest or trigger blinking, thus offering an additional means of treating dry eye syndrome.

[0023] Figure 1 This is a block diagram of the electronic components of a smart contact lens 100 according to one embodiment. The contact lens 100 includes an electronic device / circuit system for treating dry eye syndrome while being used as a conventional contact lens to provide vision correction to a user. As shown, the contact lens 100 includes at least one sensor 104 (or one or more sensors), a processor 150, a power supply 160, at least one capacitor 170 (or one or more capacitors), at least a pair of electrodes 180, a transceiver 190, a wireless charging device 194, a memory 196, and an antenna 198. Although sensor 104 is mentioned in the singular herein, it should be understood that more than one sensor may be used.

[0024] Sensor 104 is configured to detect a user's blink after the contact lens 100 is positioned on the user's eyeball. In at least one embodiment, sensor 104 is an eyelid overlap sensor, as described in U.S. Patent Publication 2018 / 0031867 entitled "Device, System and Method for Detecting Overlap of an Ophthalmic Device by an Eyelid" by Shungneng Lee et al. Such sensor 104 is also described below regarding... Figure 2 This will be described further in this article.

[0025] In some embodiments, Figure 1 The contact lens 100 includes a power source 160. In some embodiments, the power source includes a rechargeable energy storage device, such as a battery. In some embodiments, the power source 160 provides power to at least one of the sensor 104, processor 150, transceiver 190, and memory 196. The power source 160 can be configured to provide power to those components for extended periods, such as several hours or a whole day.

[0026] In some embodiments, Figure 1 The contact lens 100 includes a processor 150. The processor 150 can take the form of any known processor, such as an integrated circuit (IC), an application-specific integrated circuit (ASIC), a field-programmable gate array (FPGA), or a general-purpose processor. According to embodiments further discussed herein, the processor 150 is configured to provide any combination of the following: power management (such as managing power supply 160 or energy harvesting view wireless charging), blink sensing, blink timing, or stimulating the blink reflex.

[0027] In some embodiments, Figure 1The contact lens 100 includes one or more capacitors 170 and electrodes 180. During stimulation of the surface of the eyeball, the one or more capacitors 170 provide a portion of the electrical energy to the electrodes 180. The one or more capacitors 170 store electrical energy until stimulation is required (as electrical energy delivered per unit time, which is electricity), and the processor 150 controls the discharge time of the one or more capacitors 170. The contact lens 100 may also include a circuit system (not shown) coupling the one or more capacitors 170 to the electrodes 180, such that the electrodes provide a specific waveform having pulse amplitude (i.e., voltage or current amplitude), pulse duration, pulse frequency, on-time, off-time, etc., as known in the field of neurostimulation. The one or more capacitors 170 deliver electrical energy to the electrodes 180 to deliver any known type of stimulation waveform. The one or more capacitors 170 may include two or more capacitors (such as supercapacitors) connected in series or parallel as needed to deliver an appropriate amount of electrical energy to the electrodes 180 within a given amount of time to stimulate the eye. In some embodiments, the power source 160 recharges the capacitors 170 between discharges to keep them fully charged to deliver power to the electrodes 180.

[0028] In some embodiments, Figure 1 The contact lens 100 includes a transceiver 190 and an antenna 198. The transceiver 190 can utilize any known type of communication protocol and waveform to communicate with devices external to the user's body, such as cellular phones, smartphones, tablets, or laptops. The transceiver 190 may utilize Near Field Communication (NFC), Radio Frequency Identification (RFID), or Bluetooth Low Energy (BLE) as examples. The transceiver 190 works in conjunction with the antenna 198 to transmit or receive electromagnetic waveforms.

[0029] In some embodiments, Figure 1 The contact lens 100 includes a memory 196. The memory 196 is a semiconductor memory used to store data and / or instructions for use with other components. The memory 196 is any suitable semiconductor memory, such as random access memory (RAM) (such as synchronous dynamic RAM or SDRAM), read-only memory (ROM) (such as programmable ROM or PROM), flash memory, or any combination thereof. The memory 196 can be used to store instructions for operating the processor 150 and / or transceiver 190. Therefore, the contact lens 100 can include any combination of hardware and software utilizing the memory 196 and / or the processor 150. In an extreme case, the contact lens 100 may not include a memory and the processor 150 may be hardwired to control various components of the contact lens 100.

[0030] In some embodiments, Figure 1The contact lens 100 includes a wireless charging device 194. An example wireless charging device 194 is an antenna, such as a loop antenna. The antenna can generally take any useful form to perform wireless charging via inductive wireless charging of the contact lens 100. The antenna can reside on the surface of the contact lens 100 or can reside inside the contact lens 100.

[0031] Figure 1 Many or all of the components shown are encapsulated within a dielectric shell material (not shown). Therefore, the contact lens 100 can be covered with an overmolded material suitable for contact with the eye and eyelids, such as a hydrogel or silicone hydrogel material. The shell material includes at least some portions suitable for use as a conventional contact lens to provide vision correction to the user.

[0032] Figure 2 Presented Figure 1 A block diagram of an embodiment of the sensor 104 assembly of the contact lens 100. The sensor 104 includes a circuitry system for detecting whether at least a portion of the contact lens 100 is being overlapped by a user's eyelid. Detection of this type of overlap (referred to herein as "eyelid overlap" for brevity) can be used, for example, in communication with a remote device to assess the user's state to determine an operation to be performed by a receiving actuator, etc. Additional details regarding this sensor 104 are presented in U.S. Patent Publication 2018 / 0031867 and below.

[0033] Ophthalmic device 102 is an example of an embodiment including a lens forming a hermetically sealed housing (e.g., including illustrative dielectric housing material 110), wherein circuitry deployed within the hermetically sealed housing is operable to detect the amount of eyelid overlap of the ophthalmic device 102 with the user's eyelid. According to at least one embodiment, some or all of the circuitry deployed within the hermetically sealed housing of ophthalmic device 102 constitutes sensor 104.

[0034] In the illustrated embodiment, this circuit system includes an oscillator circuit 112 comprising a first electrode portion and a second electrode portion (not shown) extending differently along corresponding regions of the ophthalmic device 102. The first electrode portion and the second electrode portion may be different corresponding portions of a sensing loop structure. Alternatively, the first electrode portion may be coupled to the second electrode portion only via one end of the first electrode portion. The oscillator circuit 112 may operate differently under various conditions at different times to facilitate the function of the eyelid overlap sensor. For example, the first electrode portion and the second electrode portion may be configured to electromagnetically interact with the environment outside the ophthalmic device 102 via the dielectric housing material 110. The environment may include part or all of the cornea of ​​the user's eye, the tear film adjacent to the dielectric housing material 110, and a portion of the eyelid that may sometimes overlap with the ophthalmic device 102. In some embodiments, the oscillator circuit 112 may be operated to induce oscillating states in the first electrode portion and the second electrode portion.

[0035] For example, the driver circuit 118 of the ophthalmic device 100 may also be deployed within a hermetically sealed housing. The driver circuit 118 may be coupled to drive the oscillator circuit 112 with signals that cause the first and second electrode portions to emit electromagnetic fields. Interaction between the electromagnetic field and the external environment of the lens (not shown)—e.g., the environment including the tear film on the lens and / or the user's eyelids—can contribute to the signal oscillation state or oscillation response at the oscillator circuit 112. Electromagnetic interaction can cause the oscillator circuit 112 to exhibit one or more signal characteristics indicative of the amount of eyelid overlap. An oscillation detector circuit (ODC) 114, also deployed within the hermetically sealed housing, may be coupled to monitor a threshold state of oscillation of the oscillator circuit 112. As used herein, a “threshold state of oscillation” refers to an oscillation response caused by a disturbance of a first state at the oscillator circuit, but where the first state is close to an alternative second state in which such a disturbance would not cause such an oscillation response.

[0036] In one embodiment, the driver circuit 118 includes an initialization circuitry (not shown) coupled to sequentially configure multiple initialization states of the oscillator circuit 112. In this embodiment, the driver circuit 118 may also include a pulse generator (not shown) coupled to provide a corresponding perturbation for each of the multiple initialization states, wherein the ODC 114 monitors the oscillator circuit 112 to detect any occurrence of a given oscillation response to the corresponding perturbation. The ODC 114 may be coupled to determine one or more signal characteristics at the oscillator circuit 112—for example, wherein the ODC 114 detects the amount of resistance provided partially by the tear film above the ophthalmic device 100, and the varying amounts of resistance at different times due to the eyelids overlapping at least partially with the ophthalmic device 100. The detection resistance may include a threshold amount of current used to initiate oscillations of the oscillator circuit 112 (wherein the threshold amount of the input current varies at least partially depending on the amount of eyelid overlap).

[0037] ODC 114 may include or otherwise access memory resources (not shown) that store, for example, criterion information for determining whether the output of oscillator circuit 112 qualifies as an oscillatory response to a corresponding disturbance. This criterion information may include a threshold minimum number of transitions from the output of oscillator circuit 112 within a defined time period. Alternatively or additionally, the criterion information may include a threshold minimum amplitude from the output of oscillator circuit 112. ODC 114 may monitor the threshold oscillation state of oscillator circuit 112 based on the criterion information. For example, detecting such an oscillatory response may include ODC 114 identifying whether the amplitude of the oscillator circuit's output is greater than (or equal to, in some embodiments, a certain threshold minimum amplitude). In another embodiment, detecting an oscillatory response includes ODC 114 counting transitions (e.g., by threshold voltage or current levels) of the output of oscillator circuit 112 during a predefined sampling period. The total count of transitions can then be compared to a predefined threshold minimum number of transitions of the output to determine eligibility as an oscillatory response.

[0038] An evaluation circuit 116 of an ophthalmic device 100, deployed within a sealed housing, can be coupled to an ODC 114 to receive an indication of a threshold oscillation state and associate the indication of the threshold oscillation state with the amount of eyelid overlap. For example, the memory resources of the ophthalmic device 100 can store reference information corresponding to multiple initialization states (and / or corresponding oscillation responses) of the oscillator circuit 112, each with a different corresponding amount of eyelid overlap. In this embodiment, the ODC 114 can transmit an indication of a threshold initialization state for generating an oscillation response to the evaluation circuit 116. Based on this indication, the evaluation circuit 116 can perform an evaluation—e.g., including a lookup of reference information—to identify the amount of eyelid overlap corresponding to the threshold initialization state. The evaluation circuit 116 can then generate one or more signals identifying the amount of eyelid overlap.

[0039] The threshold oscillation state of oscillator circuit 112 can be based on environmental conditions that change over time, including, for example, the degree to which a user's eyelid overlaps with ophthalmic device 100. In one embodiment, ODC 114 sequentially executes multiple test rounds over time, each test round detecting a corresponding current threshold oscillation state of oscillator circuit 112. Each test round may each include multiple sample periods, each sample period corresponding to a different corresponding initialization state of oscillator circuit 112. For a given test round, the multiple sample periods of a given test round may each correspond to a different corresponding value of the input to oscillator circuit 112 having driver circuit 118. For example, the input may include current provided by a current source of driver circuit 118. In another embodiment, the input includes a voltage that biases oscillator circuit 112. The performance of a given test round may include dynamically selecting an initialization state (e.g., the level of the input) for the sample period to be executed, where the selection is based on the results of previous sample periods and a binary search algorithm.

[0040] Figure 5A and 5B The illustration shows an ophthalmic device 140 (such as ophthalmic device 100) deployed at different locations on a user's eye 130 for eyelid 134 according to one embodiment. Figure 5A As shown in illustration 120, one embodiment may include an ophthalmic device 140 (such as ophthalmic device 100) configured to be deployed in or on a user's eye 130—for example, where the ophthalmic device 140 is a contact lens to cover part or all of the iris 132 of the eye 130. Movement of the user's eye 130 and / or eyelid 134 may cause the eyelid 134 to overlap the ophthalmic device 140 at different times and in different amounts. In an embodiment, the ophthalmic device 140 includes a sensor mechanism to detect the amount of overlap of the eyelid 134—for example, based on changes in resistance that may be caused by any such overlap.

[0041] By way of illustration and not limitation, such a sensor mechanism may include circuitry (such as oscillator circuitry 112) comprising a first electrode portion 142 and a second electrode portion 144 extending differently within the light-transmitting dielectric housing material of the ophthalmic device 140. Electrode portions 142, 144 may be configured to function as respective electrode portions, each electromagnetically interacting with a tear film extending on the ophthalmic device 140 (e.g., where at least a portion of the tear film lies between the ophthalmic device 140 and the eyelid 134). Electrode portions 142, 144 may function as electrode portions extending differently across at least an angular segment (e.g., at least 30°) of the ophthalmic device 140 in a corresponding arc—e.g., where such electrode portions are interconnected to form at least a portion of a loop structure of the same single electrode. The arc electrode portions may be located near the periphery of the ophthalmic device 140 (e.g., away from its center) to mitigate interference with the user's viewing. For example, one or both of the electrode portions 142, 144 may be positioned such that at least a portion of the electrode portions 142, 144 is closer to the periphery of the ophthalmic device 140 rather than the center of the ophthalmic device 140.

[0042] In some embodiments, one or both of the electrode portions 142, 144 are also configured to electromagnetically interact with another tear film extending below the ophthalmic device 140 (e.g., between the eye 130 and the ophthalmic device 140). Figure 5B As shown in illustration 122, the eyelid 134 and / or the eye 140 can move over time, resulting in different amounts of overlap between the eyelid 134 and one or both of the electrode portions 142, 144. Different amounts of overlap of the eyelid 134 can affect one or more signal characteristics associated with the electromagnetic interaction of the electrode portions 142, 144 with the external environment of the ophthalmic device 100.

[0043] Furthermore, although electrodes 142 and 144 are in Figure 5A and 5B Electrodes 142 and 144 are not shown as part of a continuous conductor surrounding the pupil, but may instead be connected as part of a continuous conductor surrounding the pupil, for example, as shown in the image. Figure 3A and 3B As shown in the image.

[0044] Figure 1The processor 150 operates to determine the amount of eyelid overlap based on the oscillation characteristics of a circuit structure (not shown) extending within the housing 110. For example, the processor 150 may provide functionality such as ODC 114 and / or evaluation circuitry 116, and the sensor 104 may include oscillator circuitry 112 and driver circuitry 118. The sensor 104 and processor 150 may work together to provide blink detection. For example, if the user's eyelid overlaps with the ophthalmic device 102 to a degree exceeding a threshold, as detected by the processor 150 based on the output of the sensor 104, then the processor determines that a blink has occurred.

[0045] Figure 3A and 3B Different views of a smart contact lens 100 according to one embodiment are presented. More specifically, Figure 3A The view presents the contact lens 100 from the front or facing the eyelid or front side, and Figure 3B View 100 shows the back or corneal-facing or posterior-side view of a contact lens. Although the figure is two-dimensional, the back / corneal-facing surface of the contact lens is concave to conform to the eye, while the front / eyelid-facing surface is convex to conform to the corresponding eyelid, which is a typical characteristic of contact lenses.

[0046] refer to Figure 3A and 3B The contact lens 100 includes a processor 150, a battery 160, and one or more capacitors 170 (referred to herein as capacitors in the singular form). The contact lens 100 includes a radio frequency antenna 198 that can be used for communication or wireless charging, or both.

[0047] Contact lens 100 includes a pair of electrodes 180. Electrodes 180 are used to stimulate a surface of the eye, such as a portion of the sclera or cornea. As shown, electrodes 180 are positioned within or on contact lens 100 such that electrical stimulation can be delivered from the eye-facing side of contact lens 100. As previously described, capacitor 170 provides peak current support to electrodes 180 during eye stimulation. When not stimulated, electrodes 180 can be used to sense tear film quality between contact lens 100 and the eye. For example, electrodes 180 can be used to measure tear conductivity or impedance, which serves as a measurement of tear osmotic pressure, and processor 150 can convert the conductivity measurement into an osmotic pressure value using a lookup table or formula. In embodiments, contact lens 100 uses measurements of blink rate and / or tear film value to determine when to generate a stimulation signal for electrodes 180.

[0048] The contact lens includes a sensor 104. Sensor 104 provides blink detection as described above. According to embodiments, sensor 104 is capable of distinguishing between the tear film and the eyelid. For example, the tear film can conduct current sensed by sensor circuitry 104. The effect of this conductivity on the operating characteristics of the sensor circuitry can change over time with variations in the external environment—for example, due to any additional conductivity of biological materials (such as eyelids) in contact with the tear film. The degree of overlap between the eyelid and the sensor circuitry can affect the resistivity of the current path parallel to the tear film. To efficiently measure the bioconductivity / bioresistivity of the tear film (combined with any bioconductivity / bioresistivity resulting from eyelid overlap), some embodiments differently provide, for example, an inductive element coupled in parallel with a series combination of lens capacitance and tear film resistance. During the resonant state of the sensor circuitry, this inductive element can cancel or otherwise significantly cancel the impedance provided by the lens capacitance. Therefore, in the resonant state of the sensor circuit, the frequency of the oscillation can be automatically determined as the resonance of the combination of the inductor and the lens capacitance, effectively exposing the total resistance provided by the tear film and eyelids (if present)—for example, the sensing of this resistance is not masked by the impedance of the lens capacitance. This resistance can be directly correlated with the minimum current required to initiate the oscillation of the sensor circuit, and sensed by determining that minimum current.

[0049] Many or all of the circuit components may be encapsulated by the dielectric housing material 310. The housing material, represented by the illustrative dielectric housing material 310, can be used as a light-transmitting lens material and can at least partially form a sealed housing for the circuitry of the contact lens 100. The dielectric housing material 310 can be made of a variety of materials suitable for direct contact with the human eye, such as polymeric materials, hydrogels, PMMA, silicone-based polymers (e.g., fluorosilicone acrylates), or other materials. The dielectric housing material 310 may be in the form of a circular lens with a concave curvature, configured to be mounted on the surface of the eye / eyeball.

[0050] Figure 3C It shows the positioning on the user's eyes during use. Figure 3A and 3B A view of the contact lens 100 (the outer boundary of the contact lens is shown in dashed lines). For illustrative purposes, only the electrodes of the contact lens 100 are shown.

[0051] Figure 4 A method 400 for operating a contact lens, such as the contact lens 100 described herein, according to one embodiment is presented. Method 400 begins at step 410, whereby a user places the contact lens onto their eye. Before wearing the contact lens, it may be stored in a storage case that is charged by a power source or other energy storage device upon which the operation of the contact lens depends.

[0052] Once the contact lens is placed in the eye, the user can choose to calibrate the nominal and increased stimulation amplitudes using a handheld device (not shown). For example, the contact lens may include electrodes for stimulating the eye, as described previously. The nominal stimulation amplitude can be used to stimulate the eye to generate reflexive tears, for example, to provide the user with a slight sensation as if something is “in the eye,” such as a speck of dirt. The reflexive tears may be a form of basal tear replacement. The increased stimulation amplitude can be used to stimulate the blink reflex. The increased stimulation amplitude is generally greater than the nominal stimulation amplitude. The handheld device can transmit the stimulation parameters to the contact lens wirelessly. For example, the contact lens may include a transceiver and antenna as described previously.

[0053] Next, in step 420, the contact lens detects blinks, for example, using a sensor such as the previously described sensor 104, and tracks the time between blinks to determine the blink rate and also uses the time between blinks to determine whether a nominal stimulus should be applied, as discussed below.

[0054] In step 430, the contact lens determines whether the blink rate (e.g., calculated for a predetermined time period) is sufficient to provide relief from dry eye or, if appropriate, to prevent or treat dry eye. In one embodiment, the contact lens determines whether the blink rate is sufficient by comparing it to a threshold. This threshold may depend on the patient or on the time of day or any of many other parameters. If the blink rate is insufficient (e.g., less than the threshold), the method transitions to step 440, where the contact lens applies a stimulation waveform using electrodes (such as electrode 180 described herein). The stimulation waveform can use increased stimulation, using a first current or voltage amplitude value to trigger a blink reflex and increase the stimulation rate. By applying a stimulation waveform with a certain regularity or periodicity over a set time period, the contact lens can act as a blink pacemaker to ensure a sufficient blink frequency.

[0055] If the blink rate is determined to be sufficient in step 430, then step 450 is executed. In step 450, the contact lens determines whether an interstimulation period has been reached. When an interstimulation period is reached (e.g., the time since the last stimulation exceeds a threshold), a stimulation waveform is applied in step 460 using a nominal stimulus, employing a second current or voltage amplitude value provided by the electrodes. In an embodiment, the nominal stimulus is high enough to cause reflexive tearing but not high enough to generate a reflexive blink. After the nominal stimulus is applied in step 460, method 400 returns to step 420 and repeats the process. The process in method 400 is repeated as long as the contact lens remains in place on the eye. The user can remove the contact lens from the eye at any time, thus ending method 400.

[0056] After the contact lens is removed from the eye, it can be placed back in its case. Data can be collected during contact lens use, such as average blink rate over different time periods, tear osmolarity readings, and data on the frequency of applied stimulation.

[0057] Generally, any creation, storage, processing, and / or exchange of user data associated with the methods, apparatus, and / or systems disclosed herein is configured to comply with various privacy settings and security protocols, as well as current data regulations, in accordance with the consideration that the confidentiality and integrity of user data are of paramount importance. For example, apparatuses and / or systems such as contact lens 100 may include modules that implement information security controls to comply with multiple standards and / or other protocols. In some embodiments, the module receives a privacy setting selection from the user and implements controls to comply with the selected privacy setting. In other embodiments, the module identifies data deemed sensitive, encrypts the data according to any appropriate and well-known method in the art, replaces sensitive data with code to pseudonymize the data, and otherwise ensures compliance with the selected privacy settings and data security requirements and regulations. As an example, such a module may be implemented using processor 150 or a combination of processor 150 and memory 196.

[0058] Those skilled in the art will recognize that the above-described apparatus, systems, and methods can be modified in various ways. Therefore, it will be understood by those skilled in the art that the embodiments covered by this disclosure are not limited to the specific exemplary embodiments described above. In this regard, although illustrative embodiments have been shown and described, a wide range of modifications, alterations, and substitutions are contemplated in the foregoing disclosure. It should be understood that such changes can be made to the foregoing without departing from the scope of this disclosure. Therefore, it is appropriate to interpret the appended claims broadly in a manner consistent with this disclosure.

Claims

1. An electronic contact lens for treating dry eye syndrome, the electronic contact lens comprising: The concave surface is designed to conform to the patient's eye. The sensor is configured to generate signals indicating movement of the eyelid; At least one capacitor is configured to store energy for stimulating the eye; At least two electrodes are coupled to the at least one capacitor, wherein the at least two electrodes are exposed on a concave surface and are configured to deliver electricity from the at least one capacitor to stimulate the eye; as well as A processor, coupled to the sensor and electrodes, wherein the processor is configured to: Receive signals from the sensor; Determining when a blink occurs based on signals; The blink rate is calculated from a set of two or more detected blinks; and Based on the blink rate, the at least two electrodes are activated to stimulate the eye with a first stimulation amplitude.

2. The electronic contact lens of claim 1, wherein the processor is further configured to: Determine whether the interstimulation period has elapsed since the last stimulation delivered by the at least two electrodes; and Based on this determination, the at least two electrodes are activated to stimulate the eye using a second stimulation amplitude.

3. The electronic contact lens as described in claim 2, wherein the amplitude of the first stimulus is greater than the amplitude of the second stimulus.

4. The electronic contact lens of claim 3, wherein the first stimulation amplitude is configured to stimulate the blink reflex, and wherein the second stimulation amplitude is configured to stimulate reflexive tear production.

5. The electronic contact lens of claim 1 further includes a power source, wherein the power source is coupled to the processor and configured to deliver power to the processor.

6. The electronic contact lens of claim 1, wherein the concave surface is configured to at least cover the cornea of ​​the eye, and wherein the at least one capacitor, sensor, and processor are encapsulated in a housing material suitable for contact with the eye and / or eyelid.

7. The electronic contact lens of claim 1, wherein the processor is further configured to activate the at least two electrodes to stimulate the eye using a frequency based on the target blink rate.

8. The electronic contact lens of claim 6, wherein the electronic contact lens is configured to provide vision correction to the eye.

9. The electronic contact lens of claim 1, wherein the processor is further configured to: Using electrodes to measure tear characteristics; and Activation electrode is measured based on tear characteristics.

10. The electronic contact lens of claim 1, wherein the sensor comprises: An oscillator circuit, comprising a first electrode portion and a second electrode portion; as well as A driver circuit, coupled to drive an oscillator circuit with a second signal, causes the first and second electrode portions to emit an electromagnetic field extending from the electronic contact lens. Determining when a blink occurs based on signals includes: Monitor the threshold state of the oscillation of the oscillator circuit; Indicators for determining the threshold state of oscillation; and The indication of the threshold state of oscillation is correlated with blinking.

11. A non-transitory processor-readable storage medium storing a plurality of processor-executable instructions for operating a smart contact lens configured to be positioned on a user's eye, wherein, The smart contact lenses include: Sensors are configured to generate signals indicative of movement of the user's eyelids; and At least two electrodes are configured to stimulate the eye. When executed by the processor, the plurality of processor-executable instructions cause the processor to perform operations, the operations including: Based on signal repetition, determine when a blink occurs to generate a set of blinks detected at least twice; The blink rate is calculated from the at least two detected blinks; and Based on the blink rate, determine whether to activate the at least two electrodes to stimulate the eye.

12. The non-transitory processor-readable storage medium of claim 11, wherein, If the blink rate is less than a first threshold, then the at least two electrodes stimulate the eye with a first amplitude, wherein the operation further includes: Determine that the blink rate exceeds the first threshold; Determining that the time since the last delivery of the stimulus exceeds a second threshold; and Based on the determination that the first threshold and the second threshold are exceeded, the at least two electrodes are activated using a second amplitude.

13. The non-transitory processor-readable storage medium of claim 12, wherein the first amplitude is greater than the second amplitude, wherein the first amplitude stimulates the blink reflex, and wherein the second amplitude de-stimulates the blink reflex.

14. The non-transitory processor-readable storage medium of claim 12, wherein a first amplitude is selected to stimulate a blink reflex, and wherein a second amplitude is selected to stimulate reflexive tear production.

15. The non-transitory processor-readable storage medium of claim 11, wherein determining whether to activate the at least two electrodes to stimulate the eye comprises: Determine that the blink rate is less than the threshold; as well as As a result of determining that the blink rate is less than a threshold, the at least two electrodes are activated to stimulate the eye.

16. An ophthalmic device configured to conform to a user's eye and overlap with the cornea, the ophthalmic device comprising: The sensor is configured to generate a signal that instructs the user's eyelids to blink; At least two electrodes are configured to stimulate the eye; as well as A processor, coupled to the sensor and electrodes, wherein the processor is configured to: Receive signals from the sensor; Estimating when a blink occurs based on the signal; The blink rate is calculated from a set of two or more detected blinks; and Based on the blink rate, the at least two electrodes are activated to adequately stimulate the eye to generate a blink reflex.

17. The ophthalmic device of claim 16, further comprising: At least one capacitor is coupled to an electrode and configured to deliver power to the electrode sufficient to generate a blink reflex.

18. The ophthalmic device of claim 17, further comprising: The battery is coupled to the processor and configured to deliver power to the processor.

19. The ophthalmic device of claim 18, further comprising: The transceiver is configured to communicate wirelessly with a first external device; as well as A wireless charging device is configured to receive wireless power from a second external device to charge a battery; as well as The memory, coupled to the processor, is configured to store data about blink rate and stimuli delivered to the eye. The processor is also configured to control a transceiver to transmit stored data about blink rate and stimuli delivered to the eye to a first external device.

20. The ophthalmic device of claim 16, wherein the ophthalmic device is configured to provide vision correction to a user, and wherein the processor is further configured to: Tracking the time elapsed since the last stimulus was delivered; and If the calculated blink rate exceeds a first threshold and the elapsed time exceeds a second threshold, then the at least two electrodes are activated to adequately stimulate the eye to stimulate tear production but not to stimulate the blink reflex.

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