Ophthalmic devices, systems, and methods for treating dry eye

Abstract

[Solution] In some aspects, an electronic contact lens for treating dry eye 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 representative of eyelid movement, and at least one capacitor configured to store energy used to stimulate the eye. The electronic contact lens further includes at least two electrodes connected to the at least one capacitor, the at least two electrodes exposed to the concave surface and configured to provide power from the at least one capacitor to stimulate the eye. The electronic contact lens further includes a processor connected to the sensor and the at least two electrodes. The processor is configured to calculate a blink rate from the output of the sensor and to activate the at least two electrodes to stimulate the eye based on the blink rate.

Description

Technical Field

[0001] Cross - reference to Related Applications This application claims priority and benefit to U.S. Provisional Patent Application No. 63 / 060,363, filed Aug. 3, 2020, and U.S. Patent Application No. 17 / 391,835, the entire contents of which are incorporated herein by reference.

[0002] This disclosure relates to an ophthalmic device for treating dry eye, particularly (but not limited to) smart contact lenses that treat dry eye by stimulating the ocular surface.

Background Art

[0003] Since the root causes of eye dryness caused by wearing contact lenses are multifaceted, "dry eye" due to wearing such contact lenses is considered an inclusive term. Attempts have been made to solve the problem of dry eye through innovations in contact lens materials, such as improving oxygen permeability, increasing the water content of hydrogels, changing polymer formulations, and applying different surface coatings. Hydrogels aimed at increasing water content can increase the dryness of the eye in some wearers due to the difference in liquid concentration between the hydrogel and the eye.

[0004] In many cases, (except for not wearing contact lenses at all), the most comfortable eye environment for contact lens wearers with dry eye disease is when the thermal environment caused by evaporation and the concentration level of the tear film are restored by closing the eyes and the eyelids.

[0005] The basal tear production pathway is understood primarily as a closed-loop thermal system. Studies have shown that when a temperature difference is detected on the cornea due to natural evaporation of the tear film, the lacrimal glands produce tears to restore thermal equilibrium between the tear film and the corneal thermoreceptors. However, dry eye conditions can worsen if the lens maintains a thermal environment (without inducing basal tear secretion) even though the eye is dry enough to cause mechanical discomfort. Therefore, some wearers with mild dry eye symptoms may dislike wearing contact lenses because they can further exacerbate dry eye symptoms.

[0006] For example, symptoms can be temporarily relieved by applying liquid eye drops to the outside of the body. However, since this relief is only temporary, the eye drops need to be used repeatedly, which is both costly and inconvenient.

[0007] Therefore, there remains a need for devices and / or technologies to treat dry eye symptoms in contact lens wearers. The following are prior art documents related to the invention of this application (including documents cited in the international phase after the international filing date and documents cited when the application entered the national phase in other countries): (Prior art document) (Patent Document) (Patent Document 1) U.S. Patent Application Publication No. 2019 / 344077 (Patent Document 2) U.S. Patent Application Publication No. 2018 / 031867 (Patent Document 3) U.S. Patent Application Publication No. 2012 / 130398 (Patent Document 4) European Patent Application Publication No. 3255478 (Patent Document 5) International Publication No. 2016 / 065211 (Patent Document 6) U.S. Patent Application Publication No. 2018 / 173011 (Patent Document 7) U.S. Patent Application Publication No. 2020 / 196949 Specification (Patent Document 8) European Patent Application Publication No. 3125021 (Patent Document 9) U.S. Patent Application Publication No. 2014 / 192312 (Patent Document 10) U.S. Patent Application Publication No. 2018 / 136492 (Patent Document 11) U.S. Patent No. 9,764,150 (Patent Document 12) U.S. Patent Application Publication No. 2013 / 0006326 (Non-patent literature) (Non-Patent Document 1) INTERNATIONAL SEARCHING AUTHORITY / EUROPEAN PATENT OFFICE, "Notification of Transmittal of the International Search Report and The Written Opinion of the International Searching Authority, or the Declaration," for PCT / US2021 / 044383, mailed November 22, 2021, 17 pages. [Overview of the Initiative] [Means for solving the problem]

[0008] Systems, apparatus, and methods for treating dry eye are provided. In some respects, an electronic contact lens for treating dry eye is provided. In some respects, the electronic contact lens includes a concave surface configured to fit the patient's eyeball, a sensor configured to generate a signal representing eyelid movement, and at least one capacitor configured to store energy used to stimulate the eyeball. The electronic contact lens further includes at least two electrodes connected to the at least one capacitor, the at least two electrodes being exposed to the concave surface and configured to receive power from the at least one capacitor to stimulate the eyeball. In some respects, the electronic contact lens further includes a processor connected to the sensor and the at least two electrodes. The processor is configured to receive the signal from the sensor, determine the time of blinking based on the signal, 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 eyeball by a first stimulation amplitude.

[0009] In several respects, this disclosure describes a method for using a smart contact lens on a user's eyeball. The smart contact lens includes a sensor configured to generate signals representing the movement of the user's eyelids and at least two electrodes configured to stimulate the eyeball. The method for using the smart contact lens includes the steps of repeatedly determining, based on the signals, when a blink occurred and generating a set of at least two or more detected blinks; calculating a blink rate from the at least two or more detected blinks; and determining, based on the blink rate, whether to activate the at least two electrodes to stimulate the eyeball.

[0010] In some aspects, the present 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 representative of a blink of the user's eyelid, at least two electrodes configured to stimulate the eye, and a processor connected to the sensor and the at least two electrodes. The processor receives the signal from the sensor, estimates the time point at which a blink occurs based on the signal, calculates a blink rate from a set of two or more detected blinks, and based on the blink rate, operates the at least two electrodes to provide a stimulus sufficient to cause a blink reflex in the eye.

[0011] Additional aspects, features, and advantages of the present disclosure will become apparent from the following detailed description.

Brief Description of the Drawings

[0012] Exemplary embodiments of the present disclosure are described with reference to the accompanying drawings. [Figure 1] FIG. 1 is a block diagram of a smart contact lens according to one embodiment. [Figure 2] FIG. 2 is a block diagram of a sensor of a contact lens according to one embodiment. [Figure 3A-3B] FIG. 3A is a front view of a contact lens facing the front part / eyelid according to one embodiment, and FIG. 3B is a rear view of the contact lens facing the cornea. FIG. 3C shows the contact lenses of FIGS. 3A and 3B worn on a user's eye according to one embodiment. [Figure 3C] FIG. 3A is a front view of a contact lens facing the front part / eyelid according to one embodiment, and FIG. 3B is a rear view of the contact lens facing the cornea. FIG. 3C shows the contact lenses of FIGS. 3A and 3B worn on a user's eye according to one embodiment. [Figure 4]Figure 4 shows an operating method of a contact lens such as the contact lens described in this specification according to one embodiment. [Figure 5A] Figures 5A and 5B show an ophthalmic device according to one embodiment disposed on a user's eyeball for different positions of the eyelids. [Figure 5B] Figures 5A and 5B show an ophthalmic device according to one embodiment disposed on a user's eyeball for different positions of the eyelids. DETAILED DESCRIPTION OF THE INVENTION

[0013] To deepen the understanding of the principles of the present disclosure, reference will now be made to the embodiments shown in the drawings and the embodiments will be described using specific terms. However, it should be understood that this is not intended to limit the scope of the present disclosure. Any changes and further modifications to the described apparatus, system, and method, as well as any further applications of the principles of the present disclosure, are naturally contemplated by those skilled in the art of the relevant technology of the present disclosure and are included within the scope of the present disclosure. In particular, it is naturally contemplated that the features, components, and / or steps described with respect to one embodiment can be combined with the features, components, and / or steps described with respect to another embodiment of the present disclosure. However, for the sake of simplicity, these combinations will not be separately described repeatedly.

[0014] The apparatus and method described in this specification aim to assist basal tear production (which may be impaired by contact lens wear or existing mild dry eye disease) by reflex tearing. In some embodiments, the reflex tearing is stimulated by neurally stimulating the eyeball (e.g., the cornea or sclera) in the form of a contact lens, whereby the afferent nerves on the eyeball are stimulated and reflex tearing is produced through the lacrimal gland.

[0015] The contact lens shape factor maintains refractive correction for visual acuity, while also allowing tracking of blink rate, blink pattern, and / or blink detection, enabling algorithms to determine the timing and frequency of corneal stimulation. By detecting blinks at a sufficient speed, stimulation can be synchronized during blinking, resulting in a more natural and comfortable stimulation for the user.

[0016] In many cases, dry eye conditions are exacerbated by a low blinking rate. This is particularly problematic for young gamers or individuals who are overly focused, who may forget to blink while playing video games or working. Therefore, by increasing the stimulation intensity (within safe limits, of course), contact lenses can be made to function as a "blinking pacemaker," providing a sufficient stimulus to suggest or induce blinking in the user, thereby offering an additional means of treating dry eye.

[0017] Figure 1 is a block diagram of the electronic components of a smart contact lens 100 according to one embodiment. The contact lens 100 includes electronic equipment / circuitry for treating dry eye and functions as a conventional contact lens for providing vision correction to the user. As shown, the contact lens 100 includes at least one sensor 104 (or more sensors), a processor 150, a power supply 160, at least one capacitor 170 (or more capacitors), at least one pair of electrodes 180, a transceiver 190, a wireless charger 194, a memory 196, and an antenna 198. In this specification, sensor 104 is referred to in the singular, but it will be understood that multiple sensors may be used.

[0018] Sensor 104 is configured to detect the user's blink after the contact lens 100 has been placed on the user's eyeball. In at least one embodiment, sensor 104 is an eyelid overlap sensor, as described in U.S. Patent Application Publication No. 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 will be further described herein in reference to Figure 2.

[0019] In some embodiments, the contact lens 100 in Figure 1 includes a power supply 160. In some embodiments, the power supply includes an energy storage device such as a rechargeable battery. In some embodiments, the power supply 160 supplies power to at least one of the following: a sensor 104, a processor 150, a transceiver 190, and a memory 196. The power supply 160 may be configured to supply power to these components over a long period of time, such as several hours or throughout the day.

[0020] In some embodiments, the contact lens 100 in Figure 1 includes a processor 150. The processor 150 can take any known form of processor, such as an integrated circuit (IC), an application-specific integrated circuit (ASIC), a field-programmable gate array (FPGA), or a general-purpose processor. The processor 150 is configured to provide any combination of power management (such as management of power supply 160 or energy harvesting view wireless charging), blink detection, blink timing, or stimulation of the blink reflex, according to embodiments further described herein.

[0021] In some embodiments, the contact lens 100 of Figure 1 includes a capacitor(s) 170 and an electrode 180. The capacitor(s) 170 supplies a portion of the power to the electrode 180 during stimulation of the surface of the eyeball. The capacitor(s) 170 stores electrical energy (supplied as electrical energy (power) per unit time) until required for stimulation, and the processor 150 controls the timing of the discharge of the capacitor(s) 170. The contact lens 100 may also include a circuit (not shown) connecting the capacitor(s) 170 to the electrode 180, thereby providing the electrode with a specific waveform having a predetermined pulse amplitude (i.e., voltage or current amplitude), pulse duration, pulse frequency, on time, off time, etc., which is known in the art of nerve stimulation. The capacitor(s) 170 powers the electrode 180, providing any known type of stimulation waveform. The capacitor(s) 170 may include two or more capacitors, such as supercapacitors, connected in series or parallel as needed to supply an appropriate amount of power to the electrode(s) 180 for a predetermined period of time in order to stimulate the eyeball. In some embodiments, the power supply(s) 160 recharges the capacitor(s) 170 between discharges to maintain a sufficiently charged state to supply power to the electrode(s) 180.

[0022] In some embodiments, the contact lens 100 in Figure 1 includes a transceiver 190 and an antenna 198. The transceiver 190 can utilize any known type of communication protocol and waveform for communicating with devices located outside the user's body, such as mobile phones, smartphones, tablet computers, and laptop computers. The transceiver 190 can utilize, for example, near-field communication (NFC), radio frequency identification (RFID), or Bluetooth® Low Energy (BLE). The transceiver 190 works in cooperation with the antenna 198 to transmit and receive electromagnetic waves.

[0023] In some embodiments, the contact lens 100 in Figure 1 includes a memory 196. The memory 196 is a semiconductor memory used to store instructions for data and / or other components. The memory 196 is any suitable semiconductor memory, such as random access memory (RAM) (e.g., synchronous dynamic RAM or SDRAM), read-only memory (ROM) (e.g., programmable ROM or PROM), flash memory, or any combination thereof. The memory 196 may also be used to store instructions for operating the processor 150 and / or the transceiver 190. Thus, the contact lens 100 can include any combination of software and hardware that utilizes the memory 196 and / or the processor 150. In an extreme example, the contact lens 100 may not include memory, and the processor 150 may be wired to control the various components of the contact lens 100.

[0024] In some embodiments, the contact lens 100 in Figure 1 includes a wireless charging device 194. An exemplary wireless charging device 194 is an antenna, such as a loop antenna. The antenna can take any effective form that typically performs wireless charging of the contact lens 100 by inductive wireless charging. The antenna may be located on the surface of the contact lens 100 or located inside the contact lens 100.

[0025] Many or all of the components shown in Figure 1 are surrounded by a dielectric surrounding material (not shown). Therefore, the contact lens 100 may be covered by an outer covering material, such as a hydrogel or silicone hydrogel material, suitable for contact with the surface of the eyeball and eyelid. The surrounding material includes at least a portion suitable for functioning as a conventional contact lens that provides vision correction to the user.

[0026] Figure 2 shows a block diagram of one embodiment of the components of the sensor 104 of the contact lens 100 shown in Figure 1. The sensor 104 includes a circuit that detects whether at least a portion of the contact lens 100 overlaps with the user's eyelid. Detection of this type of overlap (for simplicity, referred to herein simply as “eyelid overlap”) can be used, for example, in communication with a remote device to evaluate the user’s condition and / or determine the action to be performed by a housing actuator. Additional details relating to such a sensor 104 are presented in U.S. Patent Application Publication No. 2018 / 0031867 and are described below.

[0027] The ophthalmic device 102 is an example of an embodiment that includes a lens forming a sealed enclosure (for example, including an exemplary dielectric enclosure material 110), and a circuit located within the sealed enclosure is operable to detect the amount of overlap of the user's eyelid with respect to the ophthalmic device 102. According to at least one embodiment, some or all of the circuit located within the sealed enclosure of the ophthalmic device 102 constitutes a sensor 104.

[0028] In the illustrated exemplary embodiment, such a circuit includes an oscillator circuit 112 having a first electrode portion and a second electrode portion (not shown) that extend in various ways along a corresponding area of ​​the ophthalmic device 102. The first and second electrode portions may be different parts of a magnetic induction loop structure. Alternatively, the first electrode portion may be connected to the second electrode portion by only one end of the electrode portion. The oscillator circuit 112 is capable of various operations at different times under various conditions to facilitate the functionality of the eyelid overlap detection sensor. For example, the first and second electrode portions may be configured to interact electromagnetically with the external environment of the ophthalmic device 102 through a dielectric surrounding material 110. Such an external environment may include part or all of the cornea of ​​the user's eye, the tear film adjacent to the dielectric surrounding material 110, and a portion of the eyelid that temporarily overlaps the ophthalmic device 102. In some embodiments, the oscillation circuit 112 can be operated to induce an oscillation state by the first electrode portion and the second electrode portion.

[0029] For example, the drive circuit 118 of the ophthalmic device 100 can also be located within a sealed enclosure. The drive circuit 118 is connected to drive the oscillation circuit 112 with signals that generate electromagnetic fields in the first and second electrode portions. Interaction between the electromagnetic field and the external environment of the lens (not shown), such as the tear film in contact with the lens and / or the user's eyelids, affects the signal oscillation state or oscillation response in the oscillation circuit 112. Such electromagnetic interactions cause the oscillation circuit 112 to exhibit one or more signal characteristics representing the amount of eyelid overlap. An oscillation detection circuit (ODC) 114, similarly located within the sealed enclosure, is connected to monitor the oscillation threshold state of the oscillation circuit 112. In this specification, “oscillation threshold state” refers to the oscillation response resulting from a perturbation of a first state in the oscillation circuit, the first state being close to an alternative second state in which such a perturbation is not expected to produce the oscillation response.

[0030] In one embodiment, the drive circuit 118 includes an initialization circuit (not shown) connected to sequentially configure a plurality of initialization states of the oscillator circuit 112. In such an embodiment, the drive circuit 118 further includes a pulse generator (not shown) connected to perturbate each of the plurality of initialization states, and an oscillation detection circuit (ODC) 114 monitors the oscillator circuit 112 and detects a given oscillation response generated by each perturbation. The oscillation detection circuit (ODC) 114 may be connected to determine one or more signal characteristics in the oscillator circuit 112, for example, the oscillation detection circuit (ODC) 114 detects the amount of resistance partially generated against the ophthalmic device 100 by the tear film, and the change in resistance caused by the overlap of the eyelids on at least a portion of the ophthalmic device 100 at different time points. The detection of resistance may include detecting a threshold current amount for initiating oscillation by the oscillator circuit 112 (where the threshold input current amount changes depending at least in part on the amount of eyelid overlap).

[0031] The Oscillator Detection Circuit (ODC) 114 includes, or can access, a memory resource (not shown) that stores reference information used, for example, to determine whether the output of the oscillator circuit 112 is valid as an oscillation response to a corresponding perturbation. Such reference information may include a threshold minimum number of transitions produced by the output of the oscillator circuit 112 within a predetermined time. Alternatively or additionally, the reference information may include a threshold minimum amplitude produced by the output of the oscillator circuit 112. Based on this reference information, the Oscillator Detection Circuit (ODC) 114 monitors the threshold of the oscillation state of the oscillator circuit 112. For example, detection of such an oscillation response may include the Oscillator Detection Circuit (ODC) 114 determining whether the amplitude of the output from the oscillator circuit is greater than (or, in some embodiments, equal to) a predetermined threshold minimum amplitude. In another embodiment, detection of the oscillation response may include the Oscillator Detection Circuit (ODC) 114 counting transitions in the output of the oscillator circuit 112 (e.g., through a threshold voltage or current level) during a predetermined sampling period. Next, the total number of migrations counted is compared to the minimum number of migrations, which is the threshold output for which the oscillation response is valid.

[0032] An evaluation circuit 116 of an ophthalmic device 100, located within a sealed enclosure, is connected to an oscillation detection circuit (ODC) 114 to receive an index of a threshold oscillation state, and can correlate this threshold oscillation state index 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 oscillation circuit 112, each initialization state being associated with a different amount of eyelid overlap. In such an embodiment, the oscillation detection circuit (ODC) 114 communicates an index of a threshold initialization state for generating an oscillation response to the evaluation circuit 116. Based on such an index, the evaluation circuit 116 can perform an evaluation, for example, including a lookup of reference information, to identify the amount of eyelid overlap corresponding to the threshold initialization state. The evaluation circuit 116 then generates one or more signals that identify the amount of eyelid overlap.

[0033] The threshold oscillation state of the oscillation circuit 112 may change over time based on environmental conditions, including, for example, the degree to which the user's eyelids overlap with the ophthalmic device 100. In one embodiment, the oscillation detection circuit (ODC) 114 performs a series of tests over time, and in each test, detects the threshold oscillation state of the oscillation circuit 112 at the corresponding point in time. Each test may include multiple sampling periods, each sampling period corresponding to a different initialization state of the oscillation circuit 112. For a given test among the multiple tests, each of the multiple sampling periods in that given test corresponds to a different input value provided to the oscillation circuit 112 by the drive circuit 118. For example, this input may include a current provided by the current source of the drive circuit 118. In another embodiment, this input includes a voltage that biases the oscillation circuit 112. In a given test run, a step is performed that includes dynamically selecting an initialization state (e.g., input level) for the sampling period to be executed, where this selection step is based on the results of previous sampling periods and a binary search algorithm.

[0034] Figures 5A and 5B show an ophthalmic device 140 (such as ophthalmic device 100) positioned on the user's eyeball 130 when the eyelid 134 is in different positions, according to one embodiment. As shown in inset 120 of Figure 5A, one embodiment includes an ophthalmic device 140 (such as ophthalmic device 100) configured to be positioned inside or on the user's eyeball 130 (where the ophthalmic device 14 is a contact lens that covers part or all of the iris 132 of the eyeball 130). Due to the movement of the eyeball 130 and / or the user's eyelid 134, the eyelid 134 may overlap the ophthalmic device 140 by different amounts at different points in time. In one embodiment, the ophthalmic device 140 includes a sensor mechanism that detects the amount of overlap by the eyelid 134 based, for example, on changes in resistance resulting from any overlap.

[0035] Such a sensor mechanism may include, but is not limited to, a circuit (such as an oscillator circuit 112) that includes a first electrode portion 142 and a second electrode portion 144 extending in various ways within the light-transmitting and dielectric surrounding material of the ophthalmic device 140. Each of the electrode portions 142, 144 may be configured to function as an electrode portion that electromagnetically interacts with the tear film over the ophthalmic device 140 (for example, in this case, at least a portion of the tear film is between the ophthalmic device 140 and the eyelid 134). The electrode portions 142, 144 may function as electrode portions that extend in various ways in arcs over at least several angular divisions (e.g., at least 30°) of the ophthalmic device 140, and these electrode portions are connected to each other to form at least a portion of the same single-electrode loop structure. The arc-shaped electrode portions are positioned near the periphery of the ophthalmic device 140 (e.g., away from its center) to mitigate interference with the user's vision. For example, one or both of the electrode portions 142 and 144 are positioned such that at least a portion of them is closer to the periphery than to the center of the ophthalmic device 140.

[0036] In some embodiments, one or both of the electrode portions 142, 144 are further configured to electromagnetically interact with another tear film extending below the ophthalmic device 140 (e.g., between the eyeball 130 and the ophthalmic device 140). As shown in inset 122 of Figure 5B, the eyelid 134 and / or the eyeball 140 move over time, resulting in a change in the amount of overlap between the eyelid 134 and one or both of the electrode portions 142, 144. The change in the amount of overlap by the eyelid 134 may affect one or more signal characteristics associated with the electromagnetic interaction between the electrode portions 142, 144 and the external environment of the ophthalmic device 100.

[0037] Furthermore, although electrodes 142 and 144 are not shown in Figures 5A and 5B as part of a continuous conductor encircling the pupil, alternatively, electrodes 142 and 144 may be connected as part of a continuous conductor encircling the pupil, for example, as shown in Figures 3A and 3B.

[0038] The processor 150 in Figure 1 operates to determine the amount of eyelid overlap based on the oscillation characteristics of a circuit structure (not shown) extending into the enclosure 110. For example, the processor 150 may provide functionality such as an oscillation detection circuit (ODC) 114 and / or an evaluation circuit 116, and the sensor 104 may include an oscillation circuit 112 and a drive circuit 118. The sensor 104 and the processor 150 can work together to detect blinking. For example, if the processor 150 detects that the amount of overlap of the user's eyelids exceeds a threshold based on the output of the sensor 104, the processor determines that blinking has occurred.

[0039] Figures 3A and 3B show different viewpoints of the smart contact lens 100 according to one embodiment. Specifically, Figure 3A shows a front view of the contact lens 100, i.e., the front view facing the eyelid, and Figure 3B shows a rear view of the contact lens 100, i.e., the rear view facing the cornea. Although these drawings are two-dimensional, similar to conventional contact lenses, the rear surface of the contact lens facing the cornea is concave to conform to the eyeball, and the front surface facing the eyelid is convex to conform to the corresponding eyelid.

[0040] Referring to Figures 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). The contact lens 100 also includes a radio frequency antenna 198 that can be used for communication, wireless charging, or both.

[0041] The contact lens 100 includes a pair of electrodes 180. The electrodes 180 are used to stimulate the surface of the eyeball, such as a portion of the sclera or cornea. As shown in the figure, the electrodes 180 are positioned inside or on the contact lens so that electrical stimulation can be applied from the side of the contact lens 100 facing the eyeball. As described above, the electrodes 180 are assisted by a peak current during stimulation of the eyeball. When no stimulation is applied, the electrodes 180 can be used to sense the properties of the tear film between the contact lens 100 and the eyeball. For example, the electrodes 180 can be used to measure the conductivity or impedance of the tear film, which is used as a measure of the molar osmolarity of the tear film, and the processor 150 can utilize a lookup table or formula to convert the measured conductivity to a molar osmolarity value. In one embodiment, the contact lens 100 uses measurements of blink rate and / or tear film value to determine the timing to generate a stimulation signal to the electrodes 180.

[0042] The contact lens includes a sensor 104. As described above, the sensor 104 detects blinking. According to one embodiment, the sensor 104 can distinguish between the tear film and the eyelid. For example, the tear film is conductive to the current induced by the sensor circuit 104. The effect of such conductivity on the operating characteristics of the sensor circuit changes over time due to changes in the external environment, for example, any additional conductivity of biomaterials (such as the eyelid) in contact with the tear film. Also, the resistivity of the current path parallel to the tear film may change depending on the degree to which the eyelid overlaps with the sensor circuit. To efficiently measure the bioconductivity / bioresistivity of the tear film (in combination with that resulting from eyelid overlap), some embodiments provide in various forms an inductive element connected in parallel with a series combination of the lens capacitance and the tear film resistance. While the sensor circuit is in a resonant state, such an inductive element cancels out or significantly offsets the impedance associated with the lens capacitance. Therefore, when the sensor circuit is in a resonant state, the oscillation frequency is automatically determined as the resonance due to the combination of the inductive element and the capacitance of the lens, thereby effectively revealing the total amount of resistance provided by the tear film and the eyelid (if present) (for example, such resistance is sensed without being obscured by the impedance associated with the capacitance of the lens). This resistance directly correlates to and is sensed by determining the minimum amount of current required to initiate oscillation of the sensor circuit.

[0043] Many or all of the circuit components are surrounded by the dielectric surrounding material 310. The surrounding material, represented by the exemplary dielectric surrounding material 310, functions as a light-transmitting lens material and can at least partially form a sealed surrounding for the circuit of the contact lens 100. The dielectric surrounding material 310 can be made from a variety of materials suitable for direct contact with the human eye, such as polymer materials, hydrogels, PMMA, and silicone-based polymers (e.g., fluorosilicon acrylate). The dielectric surrounding material 310 may be in the form of a circular lens with a concave curvature configured to be attached to the surface of the eye / eyeball.

[0044] Figure 3C shows the contact lens 100 from Figures 3A and 3B positioned in the user's eye during use (the outer boundary of the contact lens is indicated by a dashed line). Only the electrodes of the contact lens 100 are shown for illustrative purposes.

[0045] Figure 4 shows a method 400 for operating a contact lens, such as the contact lens 100 described herein, according to one embodiment. Method 400 begins in step 410 with the user placing the contact lens into the eye. The contact lens is housed in a storage case that charges a power source or other energy storage device that will be the source of operation before being placed into the eye.

[0046] When the contact lens is placed in the eye, the user has the option to adjust between the nominal stimulation amplitude and the amplified stimulation amplitude using a handheld device (not shown). For example, as described above, the contact lens may include electrodes for stimulating the eye. The nominal stimulation amplitude is used to stimulate the eye and generate reflex tears, giving the user a slight sensation, for example, as if something like a small speck of dust had "gotten in the eye." Reflex tears can be a form of basal tear replacement. An amplified stimulation amplitude can also be used to stimulate the blink reflex. The amplified stimulation amplitude is usually larger than the nominal stimulation amplitude. The handheld device can communicate stimulation parameters to the contact lens via wireless communication. For example, the contact lens may include the transceiver and antenna described above.

[0047] Next, in step 420, the contact lens detects blinking using a sensor such as the sensor 104 described above, tracks the time between blinks to determine the blink rate, and further uses the time between blinks to determine whether a nominal stimulus should be applied, as described below.

[0048] In step 430, the contact lens determines whether the blink rate (calculated, for example, over a predetermined period) is sufficient to alleviate, prevent, or, in some cases, 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 be patient-dependent, time-dependent, or depend on any of a number of other parameters. If the blink rate is insufficient (e.g., less than a predetermined threshold), the method proceeds to step 440, in which the contact lens applies a stimulation waveform using an electrode such as electrode 180 as described herein. The stimulation waveform uses increasing stimulation by a first current or voltage amplitude value to induce a blink reflex and increase the stimulation rate. By applying a stimulation waveform that has a certain regularity or periodicity over a set period, the contact lens functions as a blink pacemaker, thereby ensuring a sufficient blink rate.

[0049] If it is determined in step 430 that the blink rate is sufficient, then step 450 is performed. In step 450, the contact lens determines whether a predetermined inter-stimulation period has been reached between one stimulus and the next. If the predetermined inter-stimulation period has been reached (for example, if the elapsed time since the last stimulus exceeds a predetermined threshold), in step 460, a stimulus waveform is applied using a nominal stimulus supplied from the electrodes by a second current or voltage amplitude value. In one embodiment, the nominal stimulus is strong enough to produce reflex tears but not strong enough to produce a blink reflex. After the nominal stimulus is applied in step 460, method 400 returns to step 420 and the process is repeated. The steps of method 400 are repeated as long as the contact lens remains in the eye. The user may terminate method 400 at any time by removing the contact lens from the eye.

[0050] After being removed from the eye, contact lenses are returned to their case. Data such as the average blink rate over different periods, measurements of tear molar osmotic pressure, and frequency of irritation are collected during contact lens use.

[0051] Typically, all creation, storage, processing, and / or exchange of user data associated with the methods, apparatus, and / or systems disclosed herein are configured to comply with various privacy settings, security protocols, and current data regulations, which is consistent with treating the confidentiality and integrity of user data as a matter of importance. For example, apparatus and / or systems such as contact lenses 100 may include a module that implements information security controls to comply with numerous standards and / or other agreements. In some embodiments, the module receives a selection of privacy settings from the user and implements controls to comply with the selected privacy settings. In another embodiment, the module identifies data considered confidential, encrypts the data according to any appropriate and well-known method in the art, replaces the confidential data with a code that pseudonyms the data, and ensures compliance with the selected privacy settings and data security requirements and regulations if such steps are not performed. Such a module may be implemented, for example, using a processor 150, or a combination of processor 150 and memory 196.

[0052] Those skilled in the art will recognize that the apparatus, systems, and methods described above can be modified in various ways. Therefore, those skilled in the art will understand that the embodiments contained herein are not limited to the specific exemplary embodiments described above. While exemplary embodiments have been shown and described, a wide range of modifications, changes, and substitutions are possible in the above disclosure. It will be understood that such modifications can be made to the above embodiments without departing from the scope of the disclosure. Therefore, it is appropriate that the appended claims be interpreted broadly to be consistent with the disclosure.

Claims

1. Electronic contact lenses for treating dry eye, A concave surface configured to fit the patient's eyeball, A sensor configured to generate signals representing eyelid movement, At least one capacitor configured to store energy used to stimulate the eyeball, At least two electrodes connected to the at least one capacitor, the at least two electrodes being exposed on the concave surface and configured to receive power from the at least one capacitor to stimulate the eyeball, A processor connected to the sensor and the at least two electrodes, The signal is received from the sensor, Based on the aforementioned signal, the time at which blinking occurred is determined. The blink rate is calculated from one set of two or more detected blinks. Based on the determination that the blink rate is below a predetermined threshold, the at least two electrodes are activated and the eyeball is stimulated by a first stimulation amplitude configured to stimulate the nerves of the eyeball. It is determined whether a predetermined period has elapsed between one stimulus and the next stimulus from the time when the last stimulus was supplied by at least two of the electrodes. Based on the determination that the predetermined period has been exceeded, the at least two electrodes are activated and the eyeball is stimulated by a second stimulation amplitude configured to stimulate the nerves of the eyeball. The processor and Electronic contact lenses.

2. An electronic contact lens according to claim 1, wherein the first stimulation amplitude is greater than the second stimulation amplitude.

3. An electronic contact lens according to claim 1, wherein the first stimulus amplitude is configured to stimulate the blink reflex, and the second stimulus amplitude is configured to stimulate the production of reflex tears.

4. In the electronic contact lens according to claim 1, further, An electronic contact lens having a power supply, which is connected to the processor and configured to supply power to the processor.

5. An electronic contact lens according to claim 1, wherein the concave surface is configured to cover at least the cornea of ​​the eyeball, and the at least one capacitor, the sensor, and the processor are enclosed within a surrounding material suitable for contact with the eyeball and / or eyelid.

6. In the electronic contact lens according to claim 1, the processor further comprises: An electronic contact lens configured to activate at least two electrodes and stimulate the eyeball at a frequency based on a target blink rate.

7. An electronic contact lens according to claim 5, wherein the electronic contact lens is configured to provide vision correction to the eyeball.

8. In the electronic contact lens according to claim 1, the processor further comprises: Using the aforementioned two electrodes, the tear film characteristics are measured. Based on the measured values ​​of the tear film characteristics, the at least two electrodes are activated. Electronic contact lenses are what are made up of them.

9. In the electronic contact lens according to claim 1, the sensor is An oscillation circuit including a first electrode portion and a second electrode portion, A drive circuit, which is connected to drive the oscillation circuit with a second signal to generate an electromagnetic field spreading from the electronic contact lens to the first electrode portion and the second electrode portion, It has, Determining the time when blinking occurred based on the aforementioned signal is: The oscillation threshold state of the aforementioned oscillation circuit is monitored, To determine the index of the oscillation threshold state, The indicator of the oscillation threshold state is correlated with blinking. Electronic contact lenses, which include [this component].

10. A method for activating a smart contact lens, wherein the smart contact lens is A sensor configured to generate a signal representing the movement of the user's eyelids, The at least two electrodes configured to stimulate the eyeball and This method has, The smart contact lens repeatedly determines the time when a blink occurs based on the signal and generates a set of at least two or more detected blinks. The smart contact lens includes a step of calculating the blink rate from the detected at least two or more blinks, A step in which the smart contact lens determines whether to activate the at least two electrodes to stimulate the eyeball based on the blink rate, The smart contact lens includes a step of determining that the blink rate is less than a predetermined threshold, Based on the determination that the blink rate is below a predetermined threshold, the smart contact lens outputs a stimulation waveform that stimulates the eyeball using the at least two electrodes. A step of determining whether to activate the at least two electrodes having, The steps include: the outputting of a stimulation waveform having a first stimulation amplitude configured to stimulate the nerves of the eyeball when the blink rate is less than a first threshold; The smart contact lens includes the step of determining that the blink rate exceeds the first threshold, The smart contact lens includes a step of determining that the elapsed time since the last time a stimulus waveform was output has exceeded a second threshold, Based on the step of determining that the first threshold and the second threshold have been exceeded, the smart contact lens activates the at least two electrodes with a second stimulation amplitude configured to stimulate the nerves of the eyeball. A method having.

11. In the method according to claim 10, The first stimulus amplitude is greater than the second stimulus amplitude. The blink reflex is stimulated by the first stimulus amplitude. Depending on the second stimulus amplitude, the blink reflex will not be stimulated. method.

12. A method according to claim 10, wherein the first stimulus amplitude is selected to stimulate the blink reflex, and the second stimulus amplitude is selected to stimulate the production of reflex tears.

13. An ophthalmic device that is designed to fit the user's eyeball and overlap with the cornea, A sensor configured to generate a signal representing the blinking of the user's eyelids, At least two electrodes configured to stimulate the eyeball, A processor connected to the sensor and the at least two electrodes, The signal is received from the sensor, Based on the aforementioned signal, the time at which blinking occurs is estimated. The blink rate is calculated from one set of two or more detected blinks. Based on the determination that the blink rate is below a predetermined threshold, the at least two electrodes are activated to provide sufficient stimulation to induce a blink reflex in the eyeball. The processor and Having, Ophthalmology equipment.

14. In the ophthalmic device according to claim 13, further, An ophthalmic device having at least one capacitor connected to the at least two electrodes and configured to supply to the at least two electrodes sufficient power to produce the blink reflex.

15. In the ophthalmic device according to claim 14, further, An ophthalmic device having a battery connected to the processor and supplying power to the processor.

16. In the ophthalmic device according to claim 15, further, A transceiver configured to communicate wirelessly with a first external device, A wireless charging device configured to receive wireless power from a second external device and charge the battery, A memory connected to the processor and configured to store data relating to blink rate and stimuli delivered to the eyeball, It has, The processor is further configured to control the transceiver and communicate data relating to the blink rate and the stimuli delivered to the eyeball to the first external device. Ophthalmology equipment.

17. The ophthalmic device according to claim 13 is configured to provide vision correction to the user, The aforementioned processor further, Record the elapsed time since the last stimulus was supplied. If the calculated blink rate exceeds a first threshold and the elapsed time exceeds a second threshold, the at least two electrodes are activated to provide a stimulus that is sufficient to cause tear production in the eyeball but not sufficient to produce a blink reflex. An ophthalmic device configured in such a way.

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