The present disclosure relates generally to ophthalmic devices for treating dry eye, and, in particular but not exclusively, relates to ophthalmic devices for treating dry eye through heating Meibomian glands and/or cooling a surface of the eye.
Dry eye disease is one of the most common eye conditions worldwide. Many dry eye cases are related to the absence of, or severely reduced production of, meibum, an oily substance produced by the Meibomian (also expressed as meibomian) glands. There are Meibomian glands located in the upper and lower eyelids, and lipids are a major component of meibum. One of the root causes of the lack of meibum are Meibomian glands that become completely or partially clogged. Lack of meibum production and secretion are some symptoms of Meibomian gland dysfunction.
Many dry eye cases are also related to lack of tear production or tears that evaporate too quickly.
Normally, the lipid layer produced by the Meibomian glands spreads evenly into a thin protective film over the air-tear interface above the cornea. Every time a person blinks a slight amount of lipid protective film is spread. However, there are many conditions under which this oily layer no longer spreads out evenly over the tear film and this process can be interrupted, reduced, or even stopped entirely, including inadequate blinking from excessive screen time known as computer vision syndrome.
The absence of an outer protective lipid layer reduces the evaporation time for the tear film covering the eye leading to interrelated issues of inadequate production of tears and meibum.
Some treatments for Meibomian gland dysfunction include using warm compresses, eyelid cleansing compounds, and massaging the eyelids gently to try to reduce eyelid inflammation. Other known eye treatments include heating the outside of the eyelids using heating pads. Some treatments for inadequate tear production include application of various types of artificial tears. Known treatments either lack effectiveness or are too costly.
Thus, there remains a need for less costly and more convenient ways of treating dry eye disease generally, and Meibomian gland dysfunction and/or inadequate tear production in particular.
The present disclosure advantageously describes a system for treating dry eye. According to some aspects, the system includes an underlid device having an anterior surface and a posterior surface, wherein the anterior surface is configured to contact a portion of an eyelid, and wherein the posterior surface is configured to contact a portion of an eyeball. The underlid device further includes a Peltier heat pump. The Peltier heat pump includes a first surface configured to heat the eyelid when the underlid device is positioned between the eyelid and the eyeball, and a second surface configured to cool a portion of a surface of the eyeball when the underlid device is positioned between the eyelid and the eyeball. The underlid device further includes an energy storage element coupled to the Peltier heat pump and configured to supply power to the Peltier heat pump. Some embodiments further include a buck converter configured to couple the energy storage element to the Peltier heat pump.
In some aspects, the present disclosure describes a device for treating dry eye and configured to be positioned between an eyelid and sclera. The device includes a first surface that is convex for contacting the eyelid and a second surface that is concave for contacting the sclera. The device further includes an energy storage device and a Peltier device. The Peltier device includes a third surface configured to heat a portion of the eyelid and a fourth surface configured to cool a portion of the sclera when power is delivered to the Peltier device. The device further includes a circuit configured to couple the energy storage device to the Peltier device to supply power to the Peltier device, wherein heat is transferred within the Peltier device when power is supplied to the Peltier device resulting in heating of the third surface and cooling of the fourth surface, thereby heating the portion of the eyelid and cooling the portion of the sclera, respectively. In some embodiments, the circuit includes a buck converter.
In some aspects, the present disclosure describes a method of ophthalmic treatment using an underlid device when the underlid device is positioned beneath the surface of an eyelid. The underlid device includes an energy storage element, a buck converter and a Peltier device connected in series. The Peltier device includes a first surface and a second surface, wherein the first surface is configured to heat a portion of the conjunctiva of the eyelid and the second surface is configured to cool a portion of the sclera. The Peltier device is configured to transfer heat such that the first surface increases in temperature and the second surface decreases in temperature when power is supplied using the energy storage element and the buck converter. The method includes generating a signal, by a sensor, determining that a condition is satisfied based on the signal, and based on the condition being satisfied, supply power to the Peltier device using the energy storage element and the buck converter to heat the first surface and cool the second surface, thereby heating the portion of the conjunctiva and cooling the portion of the sclera.
Additional aspects, features, and advantages of the present disclosure will become apparent from the following detailed description.
Illustrative embodiments of the present disclosure will be described with reference to the accompanying drawings, of which:
For the purposes of promoting an understanding of the principles of the present disclosure, reference will now be made to the embodiments illustrated in the drawings, and specific language will be used to describe the same. It is nevertheless understood that no limitation to the scope of the disclosure is intended. Any alterations and further modifications to the described devices, systems, and methods, and any further application of the principles of the present disclosure are fully contemplated and included within the present disclosure as would normally occur to one skilled in the art to which the disclosure relates. For example, while therapeutic devices are illustrated in terms of devices placed underneath a lower eyelid for treatment of dry eye, the devices can also be placed underneath an upper eyelid for treatment of dry eye. In particular, it is fully contemplated that the features, components, and/or steps described with respect to one embodiment may be combined with the features, components, and/or steps described with respect to other embodiments of the present disclosure. For the sake of brevity, however, the numerous iterations of these combinations will not be described separately.
An exemplary system 100 for treating dry eye according to one embodiment is illustrated in
As shown in
Each device 110 is located underneath an eyelid and adjacent to an inner surface of the eyelid, as illustrated in
The device 110 comprises a first surface (or anterior surface) 114 configured to heat the eyelid when the device is positioned underneath the eyelid. Correspondingly, the device 110 comprises a second surface (or posterior surface) 116 configured to cool a surface of an eyeball when the device 110 is positioned underneath the eyelid. In some embodiments, the second surface cools scleral nerves. Directing heat to the underside of an eyelid heats Meibomian glands in the eyelid. Heating Meibomian glands may loosen oils, such as meibum, clogging or partially clogging the glands, so that the glands are unclogged, thereby secreting sufficient oil onto the surface of the eye. Insufficient oil secretion from Meibomian glands is associated with dry eye syndrome. Cooling a surface of the eyeball (using the Peltier device) may stimulate tear production, also to treat dry eye issues, such as aqueous deficient dry eye disease. These and other aspects of underlid devices 110 are explained further herein. As shown in
The frame 120 may include portions that reside over a person's ear (not shown) to hold the frame 120 in place, and the frame 210 may or may not include glass eyepieces. The frame 120 may be any sort of known eyeglass frame form factor. The frame 120 may be referred to as an external frame because it is worn outside of a human body.
The frame 120 wirelessly communicates with the devices 110, according to an embodiment. For example, the frame 120 is in communication with devices 110 to receive data from one or both devices 110. For example, a device 110 may include one or more sensors to measure variables such as temperature, blink rate, or tear osmolarity, and information collected from measurements may be communicated from a device 110 to frame 120. In an embodiment, the frame 120 also wirelessly charges each device 110 by transmitting power to each device 110, using conventional wireless charging techniques, as discussed further herein.
In an embodiment, the communication device 130 communicates wirelessly with frame 120. For example, the communication device 130 may receive data collected by frame 120, or may transmit operating instructions to frame 120. In an embodiment, the communication device 130 aggregates and/or processes received data and transmits such data or processed data to other devices via a network (not shown), such as the Internet.
An energy storage device 210 stores energy for powering device 110 (power is understood in the art to be energy delivered per unit time). Examples of an energy storage device 210 include a capacitor, such as a supercapacitor, or a battery. The energy storage device 210 includes two or more supercapacitors, which are connected in series or in parallel, according to an embodiment.
An example circuit component 220 is an antenna, such as a loop antenna. The antenna generally can take any useful form for performing wireless charging via inductive wireless charging and/or for providing communications capability for the device 110. The antenna may reside on a surface of the device 110 or may reside inside the device 110.
Exemplary device 110 in
As shown, the device 110 in
The device 110 in
The Peltier device 260 comprises a first surface (or anterior surface) configured to heat the eyelid when the device is positioned underneath the eyelid. Correspondingly, the Peltier device 260 comprises a second surface (or posterior surface) configured to cool a surface of an eyeball when the device is positioned underneath the eyelid. In some embodiments, the second surface cools scleral nerves. By powering the Peltier device 260, such as using the energy storage device 210 to apply a voltage across Peltier device 260, the Meibomian glands are heated, and the scleral nerves are cooled when the ophthalmic device 110 is mounted or positioned underneath an eyelid of the eye. By heating Meibomian glands, sufficient oils may be produced to relieve dry eye, and cooling scleral nerves can trigger reflex tear production also relieving dry eye. Cooling scleral nerves also can trigger a blink reflex, which coincides with Meibomian gland heating to provide additional assistance in oil flow from Meibomian glands. Thus, the Peltier device 260 is a convenient device for treating Meibomian gland dysfunction and/or aqueous deficient dry eye disease, leading to increased flow of meibum oil and/or increased tear production, according to at least one embodiment.
The device 110 in
An example embodiment of a buck converter 240 is illustrated in
A processor or controller, such as processor 230, controls the operation of the switch 342, according to one embodiment. In some embodiments, the switch is closed periodically for a duration of time and then opened at the end of the duration of time, and the process is repeated. Both the period and the duration of time may be adjustable to adjust the frequency of operation (computed as inverse of the period), periodicity and/or duty cycle. For example, the switch 342 may be closed for a half cycle and opened for a half cycle, wherein the cycle repeats at a frequency of several or tens or hundreds of kilohertz (kHz).
According to some experiments, 50 milliwatts (mW) of power may be used to power the underlid device 110. Operating at 50 mW for is requires 50 millijoules (mJ) of energy. Energy stored in a capacitor can be represented as 0.5*C*V2, where C represents capacitance and V represents voltage. As an example, a 7.5 millifarad (mF) supercapacitor, as an example energy storage device 210, operating at 2.6V with a 25Ω source impedance provides a small form factor. A DC-to-DC power converter, such as a buck converter, must be able to deliver 50 mW into a 0.3Ω load, according to some embodiments.
According to some embodiments, a buck converter 240 using a 30 microhenry (uH) inductor 346 that is 1 mm×0.5 mm×6 mm, switching at 100 kHz (using switch 342), is both desirable and realizable. Such a device may be about 50% efficient (limited by supercapacitor source resistance and other losses). This is much better than alternative embodiments that achieve only 1% efficiency when a buck converter is not used.
In some embodiments, wireless charging of a device 110, for example using a wireless charger in frame 120, can occur at a 20 microampere (μA) rate. A 20 μA rate of charging would take roughly 16 mins to recharge a 2.6V, 7.5 mF capacitor. It is possible to boost charging past 20 uA (e.g., up to 100 μA), which would increase the rate of charging at the expense of higher cost or complexity. Wireless charging of the device 110 may occur while power is being delivered to a Peltier device 260, according to some embodiments.
The Peltier device 260 in
The Peltier device 260
The energy source 510 may also provide energy to power the underlid device 110. The power delivery subsystem 550 allows power to be delivered from frame 120 to at least one underlid device 110, such as via wireless charging. For example, the power delivery subsystem 550 includes one or more coils (sometimes referred to herein as wireless charging coils) for electromagnetic coupling with one or more coils in an underlid device 110 to perform inductive wireless charging, according to an embodiment.
The communication transceiver 520 performs communication between the frame 120 and underlid device 110. For example, the communication transceiver 520 receives data collected in an underlid device 110. The data collected in the underlid device 110 may include temperature, osmolarity, and/or blink rate measurements. The communication transceiver 520 may utilize near-field communications (NFC), radio-frequency identification (RFID), or Bluetooth Low Energy (BLE) as examples.
The communication transceiver 540 performs communication between the frame 120 and a communication device 130, such as a cell phone or smart phone. For example, if the frame 120 receives data collected in an underlid device 110, the frame 120 can use communication transceiver 540 to send the collected data to the communication device 130, so that the data may ultimately be shared with a physician or other health care provider. As another example, the frame 120 may receive instructions for operation of the underlid device 110 from a physician or other health care provider.
The processor 530 in
Generally, any creation, storage, processing, and/or exchange of user data associated with the method, apparatus, and/or system disclosed herein is configured to comply with a variety of privacy settings and security protocols and prevailing data regulations, consistent with treating confidentiality and integrity of user data as an important matter. For example, the apparatus and/or the system, such as device 110, frame 120, and/or system 100, may include a module that implements information security controls to comply with a number of standards and/or other agreements. 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 that is considered sensitive, encrypts data according to any appropriate and well-known method in the art, replaces sensitive data with codes to pseudonymize the data, and otherwise ensures compliance with selected privacy settings and data security requirements and regulations.
Based on sensor readings, the processor determines whether a condition is satisfied. According to one embodiment, the sensors may include a pair of electrodes, and the electrodes are used to measure tear film conductance or impedance, which can be used to provide a measure of tear osmolarity as discussed herein. In one embodiment, if the tear osmolarity exceeds a threshold, thereby signaling a dry eye condition, the condition in step 720 is satisfied and a electrical power is supplied to a Peltier device to apply a heated surface of the underlid device to Meibomian glands and a cooled surface to the surface of the eye, thereby providing relief to or treating the dry eye condition. In one embodiment, a temperature sensor may be included and used to provide a measurement of temperature of an area on or near a surface of the patient underneath the eyelid, and, if the temperature exceeds a threshold, the Peltier devices will not be activated. Thus, a temperature sensor can be used to protect the eyelid from excessive heating.
The same or a different pair of electrodes can be used as a sensor for blink detection, as discussed herein. By detecting blinks and keeping track of the time between blinks, the underlid device can compute a blink rate. The blink rate may be used as a condition in step 720. For example, if the blink rate is too low, the method 700 moves to step 730 in which power is supplied to a Peltier device in the underlid device to stimulate blinking.
In step 730, power is supplied to a Peltier device to activate the Peltier device. The Peltier device may be activated according to a period and duty cycle. For example, the period may be one minute, and the duty cycle may be one percent, such that the Peltier device is activated one percent of each minute for some duration of time. The period and duty cycle may be programmable parameters stored in an underlid device. After the period of time in step 730, the state of the device returns to step 720 to check whether a condition is satisfied and the process repeats. Power may be supplied to the Peltier device using a buck converter, e.g., by periodically opening and closing the switch in a Peltier device at a given frequency, such as 100 kHz, resulting in continuous power delivery.
During the method 700, a frame is worn by the patient, such as the frame 120 described with respect to
Generally, any creation, storage, processing, and/or exchange of user data associated with the method, apparatus, and/or system disclosed herein is configured to comply with a variety of privacy settings and security protocols and prevailing data regulations, consistent with treating confidentiality and integrity of user data as an important matter. For example, the apparatus and/or the system may include a module that implements information security controls to comply with a number of standards and/or other agreements. 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 that is considered sensitive, encrypts data according to any appropriate and well-known method in the art, replaces sensitive data with codes to pseudonymize the data, and otherwise ensures compliance with selected privacy settings and data security requirements and regulations.
Persons skilled in the art will recognize that the devices, systems, and methods described above can be modified in various ways. Accordingly, persons of ordinary skill in the art will appreciate that the embodiments encompassed by the present disclosure are not limited to the particular exemplary embodiments described above. In that regard, although illustrative embodiments have been shown and described, a wide range of modification, change, and substitution is contemplated in the foregoing disclosure. It is understood that such variations may be made to the foregoing without departing from the scope of the present disclosure. Accordingly, it is appropriate that the appended claims be construed broadly and in a manner consistent with the present disclosure.
Filing Document | Filing Date | Country | Kind |
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PCT/US2020/032816 | 5/14/2020 | WO | 00 |
Number | Date | Country | |
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62847716 | May 2019 | US |