Apparatus and method for stimulating tear secretion

Abstract

In various implementations, a device for stimulating the lacrimal gland and optionally the meibomian gland of a user's eye by emitting light to the retina can include a controller and an optical system connected to the controller and positioned in a direction of the user's view. The optical system can include at least one light source and can be configured to provide light stimulation pulses to the user's eye by the at least one light source. The device implementation can also include a power supply that provides power to the controller and / or the optical system. The light stimulation pulses activate a pupillary light reflex and one or more reflexes selected from a blink reflex, a corneal reflex, a threat reflex, and a tearing reflex. When the device is in an operational mode, a light intensity gradient between the light pulses emitted by the at least one light source and the light around the eye can be maintained at 2 lumens or more. The light stimulation pulses can induce a blink of the user's eye.

Description

[Technical field]

[0001] The present invention relates generally to dry eye disease, and more particularly to devices and methods for stimulating tear production. [Background technology]

[0002] Dry eye is defined as a tear film disorder due to inadequate tear production or excessive tear evaporation. Symptoms may manifest as mild discomfort, burning pain of varying intensity, foreign body sensation, dryness, and photophobia. In severe cases, the disease may progress to affect the corneal tissue resulting in ulcers, infiltrates, and visual impairment. Age and female gender are risk factors for dry eye disease. Regardless of age, approximately twice as many women as men suffer from dry eye. The aging process appears to have a significant impact on dry eye disease (DED).

[0003] Age-related changes in the ocular surface in DED are related to biological changes in the lacrimal gland (LG) and meibomian gland (MG). The lacrimal gland is a pair of exocrine glands, one in each eye, that secrete the aqueous layer of the tear film. In humans, the lacrimal gland is located in the outer superior marginal region of each orbit, in the lacrimal fossa formed by the frontal bone. The lacrimal gland (LG) plays a vital role in maintaining ocular physiology and in age-related changes that directly affect ocular diseases. Dysfunction of the immune system in aging leads to quantitative and qualitative changes in antibodies, cytokines, proteins, and vitamins. The tear film contains tens to hundreds of proteins and other chemical molecules, such as: electrolytes (sodium, potassium, chloride, bicarbonate, magnesium, calcium), proteins (lysozyme, lactoferrin, lipocalin, IgA, EGF, other growth factors, etc.), lipids, mucins, and vitamins.

[0004] Aging lacrimal glands affect the initial chemical composition of the tear film and, consequently, ocular and eyelid function. One aspect of lacrimal gland aging is the gradual decline of the immune system, leading to increased autoimmunity through reciprocal pathways between low-level inflammation and aging mechanisms. Lacrimal gland aging is associated with functional changes, decreased innervation, and decreased secretory activity. Lymphocyte infiltration, destruction, atrophy of the gland parenchyma, ductal dilation, and secretion of inflammatory mediators alter the volume and composition of tears.

[0005] Meibomian glands (also called palpebral glands, tarsal glands, or blepharoconjunctival glands) are sebaceous glands located inside the tarsal plate along the edge of the eyelid. They produce meibum, an oily substance that prevents evaporation of the eye's tear film.

[0006] According to TFOS-II, dry eye disease is classified into two types: aqueous-deficient and evaporative. In most cases, aqueous-deficient is the result of lacrimal gland dysfunction. Evaporative dry eye is associated with meibomian gland dysfunction. (JP Craig, KK Nichols, EK Akpek, B. Caffery, HS Dua, C. Joo, MD, Z. Liu, JD Nelson, JJ Nichols, K. Tsubota, F. Stapleton, TFOS DEWS II Definition and Classification Report, The Ocular Surface Volume 15, Issue 3, July 2017, Pages 276-283, https: / / doi.org / 10.1016 / j.jtos.2017.05.008)

[0007] According to Dartt, lacrimal gland activation is also controlled by activation of sensory nerves in the corneal and conjunctival epithelium (DA Dartt, Neural Regulation of Lacrimal Gland Secretory Processes: Relevance in Dry Eye Diseases, Prog Retin Eye Res. 2009 May; 28(3): 155-177. doi:10.1016 / j.preteyeres.2009.04.003). To quote Dartt, "The first part of the lacrimal gland functional division that regulates lacrimal secretion is activation of sensory nerves in the corneal and conjunctival epithelium. The surface epithelium of the eye is rich in sensory nerve endings that respond to environmental changes and rapidly secrete lacrimal fluid to wash away foreign particles that have entered the tear film and chemically neutralize them. Stimulation of the sensory nerves in the cornea causes the lacrimal gland to secrete fluid and vasodilation. Lacrimal secretion depends on vasodilation, with increased blood flow enhancing secretion and decreased blood flow inhibiting stimulation-induced secretion." Dartt states that the mechanisms involved in coupling vasodilation and fluid secretion in the lacrimal gland are unclear.

[0008] Conventional treatments suggested by the US National Eye Institute to treat DED include: over-the-counter eye drops (artificial tears) or moisturizing gels and anti-inflammatory topical preparations, prescription medications such as cyclosporine (Restasis) and lifitegrast (Xiidra), as well as lifestyle changes such as avoiding smoke, drafts, and air conditioning.

[0009] A traditional home remedy is to apply a warm compress to the eye. According to Butcher et al. (BUTCHER EO, COONIN A. The physical properties of human sebum. J Invest Dermatol. 1949 Apr;12(4):249-54. PMID: 18120703.), the relationship between the viscosity of human sebum and temperature can be approximated as linear. Since meibum has a viscosity of about 600 millipoise at 37°C and about 1000 millipoise at 27°C, which is almost the same as sebum, it can be concluded that even slight heating of meibum by contact with the eyelid skin can significantly reduce the viscosity of meibum, improving the flow of meibum in the meibomian glands and relieving the symptoms of dry eye and meibomian gland dysfunction (MGD). Heating of the eyelid skin of the epithelial layer can be achieved by direct contact as previously proposed by Alcon Systane® iLux2®. In another instance, the combination of heat and pressure aims to achieve similar results as those demonstrated by JNJ Lipiflow. With Lipiflow, the eyelid is heated to approximately 40°C, increasing the temperature of the meibum and altering the viscosity of the meibum. Thus, by making the meibum more flowable, MGD is alleviated. The combination of a lower viscosity meibum and external pressure applied by the device provides an easily flowable meibum, restoring the flow of meibum.

[0010] Many patent publications have proposed devices based on this traditional therapy, one of which, U.S. Patent Application Publication No. 20180344512, describes a dry eye treatment device that includes a patch or strip that is applied to the skin of the upper and / or lower eyelid to apply heat or other forms of energy to one or more meibomian glands contained in the skin under the subject's eyelid. Further devices are disclosed in CN102846423, JP5137956, U.S. Patent Application Publication No. 20200146881, and U.S. Patent Application Publication No. 20210052216.

[0011] Another dry eye treatment known in the art proposes electrical nerve stimulation of the lacrimal gland using electrodes implanted in the eye. Such implants are described in EP 3349848, WO 2017072575, US 20180116872, WO 2020198444, and WO 2021086924. This is an invasive method and not suitable for everyone. US 2021138232 describes transcutaneous nerve stimulation, such as facial nerve stimulation, to artificially induce blinking, such as in people with acute facial paralysis (Bell's palsy or dry eye syndrome). US 20150100001 discloses a therapeutic ultrasound device to treat eye conditions.

[0012] Japanese Patent Publication No. 4242195 discloses an optical treatment device that stimulates the lacrimal gland to promote tear secretion. The device is equipped with a probe that emits light from its tip when it comes into contact with the upper eyelid near the lacrimal gland. The probe is equipped with a touch sensor, and treatment is performed without irradiating the eyeball.

[0013] To analyze the meibomian glands, irradiating the eyelids with infrared light (IR) to image the meibomian glands has been disclosed in US Patent Publication No. 20140330129 and Korean Patent No. 101776226.

[0014] Korean Patent Application Publication No. 1020210027842 discloses a wearable ophthalmic treatment device, which includes a component that can be worn on a user's head and a light emitting unit that emits light having a wavelength that is absorbed by the eyelid tissue of the user. The therapeutic light emitted by the light emitting unit is absorbed by the eyelid tissue and converted into thermal energy for treating dry eye syndrome, dissolving lipid residues and waste products formed in the secretory pathway and ensuring an excretion pathway. The therapeutic light has a wavelength band (900nm to 950nm, or 1140nm to 1260nm) that has the characteristic of being highly absorbed by lipids. The device includes a detection unit that detects real-time eyelid position information so that treatment can be performed according to the patient's eyelid movement.

[0015] Thus, prior art methods and devices for treating dry eye syndrome propose one of the following: Pharmaceutical compositions that require multiple ocular administrations during the day and that usually lose their effectiveness over time Medical implants A medical device that treats the eyelids or the skin adjacent to the lacrimal and / or meibomian glands by delivering light energy that is converted to thermal energy in order to artificially stimulate the lacrimal and / or meibomian glands to secrete tears or oil. Treatment is primarily provided when the eye is covered and requires direct contact of the probe with the skin.

[0016] This is the starting point of the present invention. Therefore, the aim of the present invention is to propose an alternative option for treating DED. The present invention aims to provide a device that stimulates the lacrimal and / or meibomian glands in a more natural way, a device that is safe and simple to use on the one hand and does not stress the body or damage the tissues on the other hand. Furthermore, some embodiments of the device of the present invention may contribute to the user's compliance with the treatment plan, since the user experiences a virtual reality during use. The present invention also aims to activate the blink and tear reflexes in order to rebalance the glandular function and at least partially return the original chemical composition of the tears necessary for the normal functioning of both the lacrimal and meibomian glands. Summary of the Invention

[0017] The present invention relates to a device for stimulating the lacrimal and / or meibomian glands in a user's eye.

[0018] By emitting light to the retina, the device can change the chemical composition of the tears, reactivating aged lacrimal glands to produce intense meibum secretion. The device includes a controller and an optical system connected to the controller and positioned in a direction of the user's view. The optical system includes at least one light source and is configured to provide light stimulation pulses to the user's eye by the at least one light source. The device also includes a power supply for providing power to the controller and / or the optical system. The stimulation pulses activate the pupillary light reflex and one or more reflexes selected from the blink reflex, the corneal reflex, the threat reflex, and the tearing reflex. Activating these reflexes one by one or in combination with the pupillary light reflex avoids potential damage to the eye. Furthermore, such activation induces the blinking of the user's eyes, which promotes self-regulation of the tear mechanism, resulting in natural tear secretion and relief of dry eye symptoms. The device can also improve the lacrimal gland's ability to grow more chemically balanced proteins and other molecules, such as vitamin A. In addition, it should be emphasized that the blink reflex, and the pupillary light reflex, are activated without direct contact with the eye or eyelid.

[0019] In one aspect of the invention, there is provided an apparatus for stimulating the lacrimal and / or meibomian glands of a user's eye by emitting light to the retina, the apparatus comprising: A control unit; an optical system connected to the control unit and arranged in a direction viewed by a user, the optical system including at least one light source and configured to provide light stimulus pulses to the user's eye by the at least one light source; a power supply for supplying power to the controller and / or the optical system; Equipped with The light stimulation pulse induces a pupillary light reflex, Blink reflex, corneal reflex, threat reflex, lachrymal reflex, and activating one or more reflexes selected from When the device is in an operational mode, a light intensity gradient between the light pulses emitted by the at least one light source and the light around the eye is maintained at at least 2 lumens, and the light stimulation pulses induce a blink of the user's eye. The device operates without physical contact with the eye or eyelid. One embodiment of the present invention may be a non-thermal device that uses wavelengths limited to visible light.

[0020] In one or more embodiments, the controller can be a personal computer, laptop, tablet, cell phone, or microprocessor that is wired or wirelessly connected to the optical system. The controller is programmed to activate the optical system and any other stimulation pulses and stimulation components integrated into the device. In one or more embodiments, a power supply can be integrated with or located within the optical system. In other embodiments, a power supply can be integrated with or located within the controller and can provide power to the optical system. Another embodiment of the device can be configured to plug into an external power supply, or even via a wire / adapter, into an internal power source.

[0021] In one or more embodiments, the device may further comprise a coupling means for releasably coupling the device to a headset or to regular eyeglasses or sunglasses. In some other embodiments, the device is configured as a headset configured to interconnect with a mobile phone and accommodate the mobile phone such that the display screen of the mobile phone faces the user's eye. In one or more embodiments, the at least one light source emits light in a wavelength band between 350 nm and 750 nm. In some embodiments, the light source provides light stimulation pulses in a random pattern to prevent eye intolerance. The light source generates light stimulation pulses in a random pattern that startles the user. In one or more embodiments, the optical system further comprises a lens, an adjustable lens, and / or a lens adjustment mechanism.

[0022] In one or more embodiments, the device may further comprise a sound source operable by the control. In one or more embodiments, the device may further comprise a vibration source operable by the control. In one or more embodiments, the device may further comprise a means for creating eyelash disturbance operable by the control. In one or more embodiments, the device may further comprise a rotating element positioned in the line of sight of a user and electrically connected to said power supply, the rotating element configured to allow light to pass through a lumen disposed on an outer surface thereof towards the eye of the user.

[0023] In one or more embodiments, the device may further comprise a means for providing an airflow towards the user's eye. In one or more embodiments, the device may further comprise a means for providing water droplets towards the user's eye. In one or more embodiments, the optical system further comprises a shading element operable by the controller and powered by the power supply, the shading element configured to shade and unshade the user's eye from light while the device is in the operational mode. In one or more embodiments, the device further comprises a combination of at least two of the following: a sound source, a vibration source, a means for creating eyelash disturbance, a rotation element, a means for providing an airflow, a means for providing sterile or non-sterile droplets, i.e. water, saline, water for injection, and a shading element.

[0024] In one or more embodiments, the device may further include a camera that captures the eye's response to the stimulation pulses and transmits the captured data to the control unit for analysis. In one or more embodiments, the control unit is configured to interface with a virtual reality (VR) headset, an augmented reality (AR) headset, a mixed reality (MR) headset, or any other smart headset device that can be placed on the user's face. In one or more embodiments, the control unit is further programmed to interface with the smart headset device and display a sequence of pulses toward the user's eyes and / or a sequence of pictures that induce the user's eyes to blink in a desired pattern.

[0025] The present invention relates in some embodiments to a kit for stimulating dry eye. In some embodiments of the present invention, a kit for stimulating the lacrimal and / or meibomian glands of a user's eye includes a device for stimulating the lacrimal and / or meibomian glands of a user's eye and a coupling means for releasably coupling the device to regular eyeglasses or sunglasses. In some embodiments, the device includes a controller and an optical system connected to the controller and arranged in a direction of the user's view. The optical system includes at least one light source and is configured to provide light stimulation pulses to the user's eye by the at least one light source, and the optical system includes a power supply for providing power to the controller and / or the optical system. The light stimulation pulses activate the pupillary light reflex and one or more reflexes selected from the blink reflex, the corneal reflex, the threat reflex, and the tearing reflex. When the device is in an operating mode, a light intensity gradient between the light pulses emitted by the at least one light source and the light around the eye is maintained at at least 2 lumens, and the light stimulation pulses induce the blinking of the user's eye.

[0026] Additionally, in another embodiment of the present invention, a kit for stimulating the lacrimal and / or meibomian glands of a user's eye includes a device for stimulating the lacrimal and / or meibomian glands of a user's eye, configured as a headset configured to interconnect with and accommodate a mobile phone. Additionally, the kit further includes an access code to a service provider. In operation, the service provider operates the mobile phone to emit light stimulation pulses to the user's retina to activate the pupillary light reflex and one or more reflexes selected from the blink reflex, the corneal reflex, the threat reflex, and the tearing reflex. When the mobile phone is in an operating mode, a light intensity gradient between the light pulses emitted by the at least one light source and the light around the eye is maintained at at least 2 lumens, and the light stimulation pulses induce the blinking of the user's eye. The service provider can provide an app for the mobile phone or operate the program via a website.

[0027] One aspect of the invention relates to a method for stimulating dry eye by emitting light to the retina, the method comprising: Utilizing a device to stimulate the lacrimal and / or meibomian glands of the user's eye in the vicinity of a facial region of the user's eye, the device comprising: A control unit; an optical system connected to the controller and arranged in a direction viewed by a user, the optical system including at least one light source and configured to provide light stimulus pulses to an eye of the user; a power supply for supplying power to the controller and / or the optical system; Utilizing the apparatus comprising: generating light pulses with the at least one light source and emitting the light pulses toward an eye of the user; emitting light to a retina; activating the pupillary light reflex and one or more reflexes selected from the blink reflex, the corneal reflex, the threat reflex, and the tearing reflex; inducing a blink of the user's eye, wherein when the device is in an operational mode, a light intensity gradient between the light pulses emitted by the at least one light source and the light around the eye is maintained at at least 2 lumens, and the light stimulation pulse induces a blink of the user's eye; In some embodiments, the method includes generating light stimulation pulses in a random pattern to prevent eye strain. Specifically, the light source generates light stimulation pulses in a random pattern that is startling to the user. In one or more embodiments, the optical system further comprises a lens, an adjustable lens, and / or a lens adjustment mechanism. [Brief description of the drawings]

[0028] Some embodiments of the present invention are described herein, by way of example only, with reference to the accompanying drawings. Other apparatus, methods, features, and advantages of the present invention will become apparent to those skilled in the art upon review of the following detailed description. Components shown in the drawings are not necessarily to scale and may be exaggerated to better illustrate important features of the present invention. [Figure 1A] FIG. 1 is a side perspective view of a user wearing a device for stimulating the lacrimal and / or meibomian glands and the retina, constructed and operative in accordance with a preferred embodiment of the disclosed invention, generally referenced 100. [Figure 1B] FIG. 1B is a side view of optical system 103 (as shown in FIG. 1A). [Figure 2A] 13 shows a schematic representation of the inner panel, as seen from the user's eye, of a further embodiment of a device according to the invention; [Figure 2B] FIG. 2B is a cross-sectional top view of one embodiment of the device shown in FIG. 2A. [Diagram 3] 13 shows a schematic representation of the inner panel, as seen from the user's eye, of a further embodiment of a device according to the invention; [Figure 4A] Figure 4A shows a schematic diagram of an exemplary device including a rotating element according to one embodiment of the present invention. Figure 4A is a view of the inner panel. Figure 4B shows cross section AA of the device shown in Figure 4A. Figure 4C shows the rotating element 402 of Figure 4A. [Figure 4B] Figure 4B shows a schematic diagram of an exemplary device including a rotating element according to one embodiment of the present invention. Figure 4A is a view of the inner panel. Figure 4B shows cross section AA of the device shown in Figure 4A. Figure 4C shows the rotating element 402 of Figure 4A. [Figure 4C] Figure 4C shows a schematic diagram of an exemplary device including a rotating element according to one embodiment of the present invention. Figure 4A is a view of the inner panel. Figure 4B shows cross section AA of the device shown in Figure 4A. Figure 4C shows the rotating element 402 of Figure 4A. [Diagram 5] 4B illustrates a schematic diagram of an alternative embodiment of the present invention according to one aspect of the present invention, different from the embodiment shown in FIG. 4A. [Figure 6] 1 illustrates a schematic diagram of one embodiment of the present invention in which airflow and / or water droplets are used, according to one aspect of the present invention. [Figure 7] 1A and 1B show schematic diagrams of a general configuration of an exemplary embodiment of the present invention when assembled to eyeglasses. [Figure 8] 4 illustrates optical system pulse characteristics of an exemplary optical system that can be used with the apparatus of the present invention. [Figure 9]1 illustrates a schematic diagram of one embodiment of the present invention including a vibration source operable by a control unit, in accordance with an aspect of the present invention; [Figure 10] FIG. 1 is a front perspective view of a user wearing a device for stimulating the lacrimal and / or meibomian glands, constructed and operative in accordance with a preferred embodiment of the disclosed invention, generally referenced 1000. [Figure 11] 1 provides a schematic flow chart presenting the therapeutic effect of light on dry eye according to a preferred embodiment of the disclosed invention. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0029] The following disclosure provides various embodiments or examples. Specific examples of components and arrangements are shown in the drawings and described below to simplify and facilitate understanding of the disclosure. These are, of course, merely examples and are not intended to be limiting. Thus, the present invention is not limited to the products and methods specifically described, but can be adapted to various applications without departing from the overall scope of the present invention. In addition, the present disclosure may repeat reference numbers and / or characters in various examples. This repetition is for the purpose of brevity and clarity, and does not in itself dictate a relationship between the various embodiments and / or configurations discussed.

[0030] This disclosure presents below several embodiments of a novel device designed to stimulate tear production without direct physical contact with the eye itself or the skin near the eye or eyelid. The device emits stimulation pulses toward the eye to activate the pupillary light reflex and one or more reflexes selected from the blink reflex, corneal reflex, threat reflex, and lacrimal reflex, such activation inducing tear production.

[0031] A reflex is an automatic action of the body in response to a stimulus. The anatomical pathway of a reflex consists of an afferent nerve (or sensory nerve), usually one or more interneurons in the central nervous system, and an efferent nerve (motor nerve, secretory nerve, secretagogue nerve). The pupillary light reflex is a well-known reflex. When light is shined near one eye, the pupils of both eyes constrict. Light is the stimulus, an impulse reaches the brain via the optic nerve, and a response is transmitted to the pupil musculature by the autonomic nerves that provide vision. The pupillary light reflex is a response to light, modulated by visual perception. It is therefore important to enhance the efficacy of indirect light therapy as presented in this disclosure. The pupillary light reflex controls the amount of light entering the eye, and therefore the importance of activating this reflex with a light pulse is based on the fact that, although the blink reflex is activated by light, the pupillary light reflex is important in preventing possible damage to the retina of the eye when the device is activated.

[0032] Another reflex involving the eyes is the tearing reflex. When something irritates the conjunctiva or cornea of ​​the eye, the tearing reflex causes a nerve impulse to travel along the fifth cranial nerve (trigeminal nerve) to the midbrain. The efferent limb of this reflex arc is autonomic, primarily parasympathetic. These nerve fibers stimulate the lacrimal gland in the orbit, causing tears to flow.

[0033] The blink reflex can be triggered by external stimuli such as a loud noise or a flashing light, a predefined scene, a tap on the forehead, or by directly or indirectly "teasing" the eyelashes.

[0034] The threat response is a blinking reflex that occurs in response to the rapid approach of an object. The threat reflex involves blinking of the eyelids to protect the eye from potential damage. The potential damage can be either real, i.e. a potential movement of an element towards the eye, or virtual. If the human brain interprets a visual effect as a potential real threat to the eye, the brain will react in the same way even if there is no real threat at all. For example, a series of frames making a video, such as a punch towards the user of the system, or a car chase where a car exits the device and heads towards the user's face, can result in a threat reflex, even though there is no real contact between the virtual object and the eye.

[0035] The corneal reflex causes both eyes to blink in response to tactile stimulation of the cornea. The cornea is the first material, so when an irritant or foreign body comes into contact with the eye, the irritant or foreign body touches the cornea. Touching the cornea initiates the corneal reflex and tear production. The reflex is activated when a sensory stimulus contacts either the free nerve endings or the mechanoreceptors located in the epithelium of the cornea.

[0036] When activated, any one or a combination of the above reflexes stimulate the lacrimal and / or meibomian glands to produce tears. Furthermore, any combination of the blink reflex, corneal reflex, threat reflex, and tearing reflex can induce a stronger blink than a voluntary blink alone. Such a stronger response can alleviate dry eye symptoms in both the lacrimal and meibomian glands.

[0037] To summarize the above, light pulses emitted from the device of the present invention induce neural signals that travel through two separate anatomical pathways: 1. Optic tract fibers terminating in the pretectal nucleus of the midbrain 2. Autonomic nervous system, mainly parasympathetic nervous pathways.

[0038] In addition, it activates the sensory nerves of the corneal epithelium and conjunctival epithelium, and stimulates the sensory nerves of the cornea, which in turn stimulates the lacrimal gland through a geminate-parasympathetic reflex.

[0039] One embodiment of the disclosed device provides a non-contact eyelid or orbital treatment for DED. Stimulation pulses emitted towards the open or closed eye activate a series of blinks, which reactivates the lacrimal gland and optionally the meibomian gland, resulting in tear production and self-repair of the tear mechanism. In particular, the use of the device of the present invention is advantageous when the blink reflex is weak for environmental reasons, such as prolonged exposure to a computer screen at work. During operation of the device, the eye is open or closed, depending on the intensity of the pulses emitted from at least one light source and the physical state of the eye. These reflexes can be activated simultaneously or one after the other. Stimulation therapy combining specific patterns and combinations of stimuli can also be utilized for specific diseases. The retina contains molecules that undergo chemical changes when light is absorbed. For example, retinol can be converted to retinal, which is a chemical required for rhodopsin, which allows night vision. When light enters the eye, molecules can undergo isomerization, i.e., a change in their molecular arrangement. The new molecular shape may not fit the protein equally well, initiating a series of structural changes in the protein. (Chemistry LibreTexts. 2016. Chemistry of vision, available online at: <https: / / chem.libretexts.org / Bookshelves / Biological_Chemistry / Supplemental_Modules_(Biological_Chemistry) / Photoreceptors / Chemistry_of_Vision> )

[0040] The device of the present invention activates the blink reflex, causing the lacrimal gland to produce excess tears, and also alters the composition of proteins in the tear film, affecting biochemical processes in the eye and eyelid. Among the proteins in the tear film, growth factors, other proteins, and vitamins such as vitamin A play important roles in regulating the dry eye process.

[0041] definition As used herein, the term "headpiece" and its derivatives refer to any of the following non-limiting examples: a headset, headphones, glasses, sunglasses, or any other device that can be worn on a user's head and coupled to a device of the present invention.

[0042] The term "user" and its derivatives are used herein to denote any person or animal that would benefit from stimulation of the lacrimal and / or meibomian glands.

[0043] The term "eye" or "eyes" is used herein to refer to one eye / eye of a user or both eyes / eyes of a user.

[0044] As used herein, the term "virtual reality headset" is interchangeable with the term "VR headset" and refers to a smart headset device. Additionally, the term "virtual reality headset" includes a virtual reality (VR) headset, an augmented reality (AR) headset, a mixed reality (MR) headset, or any other smart headset device that can be placed on a user's face.

[0045] As used herein, the term "stimulus pulse" and its derivatives include a light pulse, a sound pulse, a vibration pulse, eyelash ruffling, airflow, or any combination thereof that activates one or more reflexes selected from the blink reflex, the corneal reflex, the threat reflex, the tearing reflex, or the pupillary light reflex.

[0046] As used herein, the term "stimulating the lacrimal gland and / or the meibomian gland" refers to stimulation of the lacrimal gland alone, stimulation of both the lacrimal gland and the meibomian gland, and stimulation of the meibomian gland alone, where stimulation of the lacrimal gland is accompanied by activation of the meibomian gland. The preferred meaning is to stimulate the lacrimal gland and, optionally, the meibomian gland.

[0047] Reference is now made to FIG. 1A, which illustrates a side perspective view of a user wearing a device for stimulating the lacrimal and / or meibomian glands, generally referenced 100, constructed and operative in accordance with a preferred embodiment of the disclosed invention. The device 100 is configured as a headpiece wearable on the user's head. The device 100 includes a controller 101 connected to an optical system 103 via wires 102. Optionally, the controller 101 can include a wireless connection to the optical system 103. The controller 101 is programmed to operate the optical system and any other means integrated into the device for providing stimulation pulses. The optical system 103 is configured to provide stimulation pulses to the user's eyes by at least one light source (not shown). The optical system 103 is positioned in a direction in which the user looks. The optical system 103 can further include a lens, an adjustable lens, and / or a lens adjustment mechanism (not shown). In other embodiments, the light source provides the light stimulation pulses in a random pattern. The light source can include an array of LEDs that can emit light all at once or can emit light one after the other in any number of configurations and patterns desired to achieve the result.

[0048] The optical system 103 further includes a power supply so that it can be self-powered. The power supply can include a battery, a radiative power source, or a solar panel. Alternatively, the optical system 103 can be powered by the controller. In the embodiment shown in FIG. 1A, the power supply is integrated with the controller 101. However, it should be noted that the power supply can be integrated with or located within the optical system as well. In other embodiments, the device can be configured to plug into an external power supply, or even via a wire / adapter to an internal power source.

[0049] FIG. 1B is a side view of the optical system 103 (shown in FIG. 1A ) depicting the arrangement of the light panel 106 and the direction of light 107 toward the user's face. Note that the light source does not contact the skin or eyelids. The light panel 106 can have at least one light source that emits light to either eye of the user. However, some embodiments of the present invention can include two or more light emitting sources, if desired. The light pulses are emitted in a random sequence. In some embodiments, the light source provides light stimulation pulses in a random pattern and random sequence to prevent the eyes from becoming tolerable. In other words, the light source generates light stimulation pulses in a random pattern that surprises the user. In one or more embodiments, the optical system further comprises a lens, an adjustable lens, and / or a lens adjustment mechanism that is adjustable horizontally, vertically, or a combination thereof to fit a particular facial structure.

[0050] The light source is limited to the visible spectrum (wavelengths between 350 nm and 750 nm). It is noted that one embodiment of the device can only use wavelengths limited to visible light. This embodiment can include specialized filters and other means to reduce IR radiation. The maximum light intensity depends on the light source, the sequence of pulses, and other factors, as described in Boyuan Yana et al., “Maintaining ocular safety with light exposure, focusing on devices for optogenetic stimulation”, Vision Res. 2016 April; 121: 57-71. doi:10.1016 / j.visres.2016.01.006. In addition, the American National Standards Institute (ANSI) Z136.1-2000 standard provides details on the amount of energy in ophthalmic devices. For example, some embodiments of the device of the present invention can emit light at an intensity of 5 lumens to 2500 lumens measured at a distance of 1 cm from the light source. It should be noted that the device can include a pulsed light source encased in a confined chamber for devices of various sizes. The light source pulse maintains the requirement that the light intensity gradient between the light source and the surroundings must be at least 2 lumens.

[0051] Further, the controller may be programmed to operate the optical system in a predefined sequence depending on the required treatment. The controller may further comprise a user-friendly app that allows the user to select the most suitable treatment for his / her eye condition. Such an app may be a computer program or application software designed to run on a mobile device such as a phone, tablet, smartwatch, etc. Optionally, the controller includes an algorithm programmed to enable the optical system to generate a sequence of pulses with a periodicity varying between 0.1 msec (milliseconds) and 10 minutes. The number of pulses per session shall vary between 1 pulse and 1000 pulses. The treatment plan shall include 1 to 20 treatment sessions every 1 to 100 days.

[0052] Referring again to FIG. 1A, the shading element 104 is disposed between the light source or light source panel and the eye (one or both eyes) and is configured to maintain a light intensity gradient between the light source and the surroundings of at least 2 lumens. Alternatively, the device can operate in a dark environment, whereby the light gradient between the light source and the surroundings is the same expected light gradient. In the embodiment shown in FIG. 1A, the control unit 101 is also connected to the earphone 105 by an electric wire. It should be noted that the shading element may be in contact with the face only for the purpose of shading, i.e., to provide a sufficiently dark environment necessary to induce blinking. Therefore, the shading element is not an active element in stimulating any of the tearing reflex, blink reflex, corneal reflex, threat reflex, or pupillary light reflex. The shading element is an optional element.

[0053] Further embodiments of the device 100 can be designed to couple to regular eyeglasses or sunglasses. Another embodiment of the device 100 can be configured to couple to conventional headphones. Furthermore, further embodiments of the device 100 can be configured to be interconnected with a virtual reality (VR) headset, an augmented reality (AR) headset, a mixed reality (MR) headset, or any other smart headset device that can be placed on a user's face. Furthermore, the device 100 can be powered by the control unit 101 or the optical system 103, or can be configured to be self-powered by any power supply means, such as a battery, a radiative power source, a solar panel, etc.

[0054] When worn on the user's head, the device 100 can optionally be used with an external controller, such as a personal computer, laptop, tablet, cell phone, or any other microprocessor controlled device, capable of controlling the optical system worn on the user's head. In another embodiment, the controller is located within the device. Furthermore, in further embodiments of the present invention, the controller includes two elements, one external to the device and the other mounted within the device. In such an embodiment, both elements are wirelessly interconnected.

[0055] The control unit 101 is programmed to activate the optical system 103 to generate stimulation pulses to control the blink reflex and / or pupil reflex and / or tearing reflex of the user's eyes without contact with the light emitted from the light source 107 mounted on the panel 106 (FIG. 1B). The eye reflex can be activated not only by using an indirect light pulse, but also by using any one of the following optional additional means: sound pulse, vibration pulse, eyelash disturbance, any combination thereof. The sound pulse can be activated in parallel with the light pulse or separately. The sound pulse can create a secondary frightening reflex. The characteristics of the sound pulse have similar characteristics to the light pulse.

[0056] Optionally, the light and audio pulses can be configured to describe realistic scenarios, such as a short video of a car driving towards the user's eyes to activate the threat reflex of the eyes as a result of the user's reaction to a hypothetical or augmented threat to the eyes, which can be combined with audio, and optionally with vibration, to together create what the user perceives as a realistic scenario that activates the threat or panic reflex of the eyes resulting in rapid blinking of the eyelids.

[0057] The control unit 101 can be programmed to activate the optical system 103 to generate a sequence of light pulses in the visible range at frequencies ranging from 10 pulses per second to one pulse every 5 minutes. The duration of the pulses may vary between 0.1 milliseconds and 20 seconds to initiate the photolacrimation reflex. The retina secretes tears through the afferent visual pathway and the efferent lacrimal canal while being stimulated by excessive light. It should be noted that the optical system 103 is not connected to the eyes, eyelids, or face.

[0058] The device may generate audio from 5Hz to 20Khz, in compliance with the limits set out in ISO Standard 1999. In some embodiments, the device generates audio from 5Hz to 10Khz. The EU has published a report of a scientific committee on potential health risks from exposure to noise from personal music players and mobile phones, including music playback capabilities. The design of the device will comply with the requirements set out in this report. Sound pressure values ​​may vary between 1dB and 135dB. Audio pulses may vary between 0.01 seconds and 5 minutes.

[0059] Reference is now made to FIG. 2A, which shows a schematic view of the inner panel, seen from the user's eye, of a further embodiment of the device according to the invention, generally referenced 200. The mounting structure 201 serves as a framework or panel for the optical system 200, including the light source elements 202. The mounting structure 201 can be made of a hard material, such as metal, or a flexible material, such as a polymer or elastomer, e.g. rubber, silicone rubber, EPDM, PET, nitrile, polyacrylic rubber, fluororubber, thermoplastic elastomer, polysulfide. The mounting structure 201 can have the shape of a regular pair of glasses, as depicted in FIG. 2A. Alternatively, the mounting structure 201 can be configured as a solid sphere to prevent light from passing through the front side of the device.

[0060] The light source 202 is mounted on the mounting panel 201 and connected to a power supply 206, which is an internal power pack (e.g., rechargeable or disposable batteries). The power source can be coupled to an external power source. The light source 202 can comprise, for example, an LED string, a light bulb, an electroluminescent display (ELD), an LCD display, an OLED display, or any combination thereof. The light source 202 can be configured to emit light pulses, light frames, or short video scenarios or scripts to activate the eye and induce the blink reflex, and / or the pupillary light reflex, and / or the tearing reflex. A combination of different types of reflexes is required to activate the tear gland and, optionally, the meibomian gland. The pupillary reflex (pupil light reflex) is activated when light is emitted directly to the retina and the light gradient between the projected light and the light level of the peripheral area is maintained at 2 lumens.

[0061] The system can include at least one light source that emits light. In some embodiments, the device includes 1 to 10 light sources. However, the number of light sources can vary and depends on various device parameters and light source characteristics. The shading element 203 is positioned to cover the entire volume between the mounting structure 201 and the user's face, or to cover a portion of the mounting structure's circumference that varies between 5% and 100%. The shading element 203 can be made of fabric, elastomer, polymer, or any other combination thereof.

[0062] Before operating the device, the eye is exposed to a dark environment due to the use of the light blocking element 203. Upon operation, the light source 202 emits light to activate one or more of the above-mentioned reflexes, causing the eye to blink due to the sudden exposure of the retina of the eye to light in the visible range. Each light source can be operated alone or simultaneously with at least one other light source. The sequence of light pulses is random and unexpected. The sequence of light pulses can be in various patterns from various angles and directions. The light pulses can be programmed to activate blinks in each eye separately according to the blink reflex, corneal reflex, threat reflex, tearing reflex, and / or pupillary light reflex, although activation of said reflexes in one eye may activate reflexes in both eyes simultaneously. To allow activation of each eye separately, an optional partition 205 is placed between the multiple light sources (optionally attached to the mounting structure 201) to better separate the multiple light sources.

[0063] One embodiment of the device may include a feedback element such as a camera 204. The camera 204 is provided to allow closed loop control over the activation of various ocular reflexes and to allow the characteristics of the light pulses, such as light intensity, pulse duration, and sequence of pulses, to be altered according to the user's requirements. The camera may also be provided as an option to better monitor and control the sound and vibration characteristics used to elicit the threat reflex alone or in parallel with the sequence of light pulses. Furthermore, in another embodiment of the invention, a camera is interconnected with the light source and control to measure the time elapsed from blinking until the tear film breaks up to assess the tear breakup time (TBUT). The measurement results may be presented in seconds or in any other display format. The system may be used for evaluation before, during, and / or after treatment. The evaluation may provide an indication of the user's progress. Another embodiment of the device may include a feedback element such as a camera or light sensor that may evaluate, for example, the effectiveness of blinking as a function of reflex activation mechanisms (light, sound, stimuli, etc.) and combine the activation sequence, intensity, period, frequency, light, and / or sound with a "stimulus algorithm" to, for example, change the VR scenario (i.e., from a car race to a snow collapse).

[0064] In some embodiments, the device may include one, two, or up to ten cameras that allow for recording correlations between multiple reflex activation methods, namely light, sound, vibration, eyelash stimulation as described below, as well as the eye pupil reflex, blink reflex, and tear reflex. The reflex responses shall be analyzed using deep learning algorithms aimed at analyzing blink characteristics. The deep learning algorithms allow for correlations between blink characteristics such as blink rate and pupil size with activation of various reflexes. Additionally, the data may be integrated into AI algorithms to teach the system to tailor the sequence of various pulses to suit a particular user based on their unique behavior following the reflex activation elements described herein. FIG. 2B is a top cross-sectional view of one embodiment of the device shown in FIG. 2A. The light source (FIG. 1A), which may be parallel to the mounting structure 201, may be angled (207) as shown in FIG. 2B. The angle may vary between 0 degrees and 45 degrees.

[0065] FIG. 3 shows a schematic of the inner panel of a further embodiment of the device according to the invention, generally referenced 300, as seen from the user's eye. FIG. 3 depicts an exemplary system configuration of a light source. The light source 301 in this embodiment includes a light emitting element array emitting light in the visible range with a light intensity of up to 2500 lumens. In some cases, the light intensity can be a function of the light pulse. For example, in a very fast pulse between 0.1 milliseconds and 100.0 seconds, the light pulse can reach a maximum value, while in a long light pulse, the light intensity can decrease from 100 lumens to up to 400 lumens. As mentioned above, the light source 301 can include an LED array, a light bulb, an electroluminescent display (ELD), an LCD display, an OLED display, or any combination thereof. The light emitting element array 302 can include a single light source to up to 10,000 individual elements arranged in rows and columns, with one or many rows of light sources. The number of rows and columns can vary between 1 and 5,000. The size of the light sources can vary, for example, between 0.5 cm and 15 cm (in length) for each of the light source arrays 302. This size is of course by way of example only and is not intended to be limiting. The light sources can include strings of LEDs that can emit light in unison or can emit light one after the other in any number of configurations and patterns desired to achieve the result.

[0066] The light source 301 can emit light in the entire visible range. Furthermore, the light source 301 can emit a single color, i.e., white, blue, green, red, or any combination of RGB (red, green, blue), or any color defined by the light composition of the Pantone color scheme. The refresh time for the light source 301 to generate a new light pulse varies between 1 millisecond and 2 minutes.

[0067] A particular embodiment of the device can include an array of light emitting elements that can project light according to a pre-designed pattern towards the user's eyes. Exemplary patterns include horizontal, vertical, circular, etc. The user follows the light path and in so doing exercises the eye muscles. A further embodiment of the device is an eye training application. The light sources of the device can be configured to teach controlled eye movements to train the eye muscles. One example is light sources arranged in rows and columns, or arranged at random angles. The operator can select a row or column, or a specific LED or light source, to perform the training. A similar solution can be obtained with a raster type display consisting of multiple pixels. The operator can turn on and off lights in a specific row, column, or angle to create a controlled eye movement to train the eye muscles. The lighting sequence can include only light sources on one side (right or left) and / or both sides at the same time. Another option is a single light, or an array of LEDs or pixels. The light sequence can last for 0.1 to 300 seconds when the light source is on. The treatment sequence may take from 10 to 2000 seconds. The interval between turning on and off the light source may be from 0.1 to 300 seconds. Figures 4A to 4C depict a schematic diagram of an exemplary device, generally referenced 400, including a rotating element according to one aspect of the present invention. Figure 4A is a view of the inner panel. Figure 4B shows cross section AA of the device shown in Figure 4A. Figure 4C shows the rotating element 402 of Figure 4A. This embodiment activates the pupillary reflex, blink reflex, corneal reflex, tearing reflex, and menace reflex (individually or in any combination thereof). It should be understood that the rotating element may be used in combination with any other embodiment of the present invention.

[0068] FIG. 4A depicts a light source 401 and a rotating element 402. As can be seen in FIG. 4B, the rotating element 402 is a disk placed between the light source 401 and the user's eye 404. Optionally, the rotating element 402 can have one of the following shapes: circular, elliptical, irregular, rectangular, or a disk with an irregular extension. One example is a fan 410 as shown in FIG. 4C. The rotating element 402 can include a series of lumens 411 (light sources) that allow light to pass through the rotating element. The number of lumens 411 per rotating element can vary from 1 to 10,000,000, and the lumens can be randomly placed on the rotating element. The rotating element 402 rotates around a central axis 412. The rotation speed can be one revolution or continuous revolutions at a frequency of 0.001 Hz to 100 Hz.

[0069] In one configuration of rotating elements, the rotating elements, in addition to the optical effect, can take the form of a fan capable of delivering air at 0.1 cfm to 50 cfm in a continuous mode or in pulses lasting 1 to 1000 seconds during treatment. The airflow can activate the corneal reflex by creating an airflow over the eyelashes. The rotating disks can be operated simultaneously or separately.

[0070] With reference to FIG. 4B, it can be seen that the rotating element 402 is placed near the eye and the electric motor 403 is placed between the rotating element 402 and the light source 401. The rotation of the rotating element can be performed by an integral or external electric motor (DC, brushless, DC brushless, AC motor) 403, or a solenoid. In addition, instead of the electric motor 403, a linear motor, or optionally a solenoid 413 (FIG. 4C), can be used as an actuator to generate the movement of the rotating element. The movement range can be limited from 5° to a maximum of one revolution. The sequence of light pulses can be synchronized to allow optimal activation of the eye reflexes based on actual dry eye relief results and / or based on data collection and analysis by AI. The fan-like element can include a housing 405 (FIG. 4C).

[0071] FIG. 4B shows the orientation of the fan and shows a schematic fan assembly, light source, and eye. When the fan is installed, the purpose of the fan is to combine the light pulse with airflow over the eyelashes ranging from 0.01 cfm to 50 cfm. When two fans are installed, each fan can be operated at different airflows. Additionally, each fan can operate independently of the other fan. In some cases, only one fan is operated and the other is off. The fans can be operated continuously or in a pulsed manner to generate airflow pulses.

[0072] An alternative embodiment to that shown in Figures 4A-4C is shown in Figure 5, where the device 500 generally includes a rotating element 501 made of a rigid material or a flexible material that can be formed into various shapes as described in connection with Figures 4A-4C. In this embodiment, the rotating element 501 is a disk of irregular shape 505. In this embodiment, similar to the embodiment depicted in Figures 4A-4C, the rotating element 402 is placed between the light source 401 and the eye and includes a series of lumens 502 that allow light to pass through the rotating element, as shown in Figure 5. The number of lumens 502 per rotating element can vary from 1 to 100, and the lumens can be randomly positioned on the rotating element. The rotating element rotates about a central axis 507 (second rotation axis). The rotating element 501 can induce blink, tearing or threat reflexes (together or any combination of reflexes or each reflex separately) by element rotation or by a combination of element rotation and light activating the photolacrimation reflex. The rotation speed can be one revolution or continuous revolutions with a frequency between 0.1 Hz and 100 Hz. The rotating element can be placed in a spatial angle (506, 504). The rotating shaft shall be driven by an electric motor or solenoid 503.

[0073] FIG. 6 depicts one embodiment of the present invention in which airflow and / or water droplets are used to stimulate the pupillary light reflex, and / or blink reflex, and / or tearing reflex, and / or threat reflex, or any combination of these reflexes. In a liquid spray system, the device 600 comprises a liquid container 601 housed in a housing 602. The liquid in the container can be sterile or non-sterile and is kept at a temperature between 0° C. and 60° C., preferably at room temperature. For example, the liquid is water or saline. A pump or piston 603 is connected to the container 601 and generates sufficient pressure required to supply the liquid from the container 601 through a tube 604 to a nozzle 607 located inside the device 600. The device 600 can include 1, 2, 3 to 6 nozzles 607 capable of generating small droplets and sprinkling a small amount of the liquid in the device around the user's eye. The blinking and tearing reflexes are activated if the droplets reach the eyelid or cornea while being dispensed. The liquid container 601 and the pump 603 can be integrated into the housing 602. Alternatively, the device 600 can be configured to include the liquid container 601 and the pump 603 in a special compartment integrated with its mounting structure, for example mounting structures 106 (FIG. 1) or 201 (FIG. 2A). Optionally, a circulation system for air or other gases such as nitrogen, CO2, argon, etc., which can be added to the embodiment depicted in relation to FIG. 6, consists of an electric fan or blower 606 installed on the walls of the device (external or internal walls, and on each wall, i.e., sides, top, bottom). An air filter 605 can also be installed to prevent particles from entering the internal volume of the device and irritating the eyes. The ventilation system provides airflow inside the device, which activates the blinking and tearing reflexes. The fan or blower can be connected to a nozzle 607 inside the device for uniform airflow inside the device.

[0074] Referring now to FIG. 7, a schematic configuration of an exemplary embodiment of the present invention when assembled to eyeglasses is depicted, generally referenced 700. The device 700 includes a coupling means 704 for releasably coupling the device to regular eyeglasses or sunglasses or goggles. Optionally, the coupling means 704 can also be configured to couple to a headset or any other headpiece. The light emitting element 701 is placed on the front of the device, on the front frame 702 of the goggles. The rear goggle element over the ear includes the sound generating element 703. The light emitting part is rigidly connected to the goggles using a latch as the coupling means 704, or any other fastener that provides a sufficiently strong and secure attachment. In another embodiment, the coupling means 704 can be a magnetic pin and / or a nose piece that allows height adjustment to accommodate different users. The device can include a light blocking element 705 similar to that shown in FIG. 2A. It should be noted that all mechanical parts described in the figures of the present invention may or may not contact the eye, eyelashes, and / or eyelids.

[0075] FIG. 8 shows the optical system pulse characteristics of an exemplary optical system that can be used with the device of the present invention. The light intensity 801 as a function of time can have various pulse shapes. For example, a step function with pulse duration 802 and intensity a can vary between 1 ms and 5000 s, and the time interval b between multiple pulses can vary between 1 ms and 5000 s. The duration of the second pulse 803 can be similar to the first pulse or slightly longer as shown. The number of pulses per session can vary from 1 pulse to 5000 pulses. Another pulse shape is a trapezoid, or trapezoidal shape, where the relationship 806 between light intensity and time taken is of the form PL=f(t). The function can be linear, logarithmic, exponential, or polynomial up to the tenth order. The total pulse duration 804 (D) can vary between 1 ms and 5000 s, and the time interval 805 between multiple pulses can vary between 1 ms and 5000 s. The number of pulses per session can vary from 1 pulse to 5000 pulses. Yet another is shown in the graph below, where the pulse shape is a sawtooth or sawtooth-like shape 807 with a relationship 808 between light intensity and time taken of the form PL=f(t). The function can be linear, logarithmic, exponential, or polynomial up to the 10th order. The total pulse duration 808 can vary between 1 millisecond and 5000 seconds, and the time interval 809 between multiple pulses can vary between 1 millisecond and 5000 seconds. The number of pulses per session can vary from 1 pulse to 5000 pulses. In some embodiments, the light source provides light stimulation pulses in a random pattern to prevent tolerability. For example, a combination of various pulse shapes and durations selected from a predefined data set for a specific disease and age. The light source generates light stimulation pulses in an unpredictable pattern that surprises the user. In one or more embodiments, the optical system further comprises a lens, an adjustable lens, and / or a lens adjustment mechanism.

[0076] FIG. 9 is a schematic diagram of an embodiment of the present invention including a vibration source operable by a control, generally referenced 900. As shown, FIG. 9 depicts a piston 901 configured to produce a combination of portion sound and vibration as a function of time. The piston 901 (mechanical, electric, magnetic, pneumatic) may actuate various pulse shapes. The piston 901 may be open-loop controlled or closed-loop controlled (not shown in the figure). For example, a step function with a pulse duration 802 that may vary between 1 ms and 5000 s, and a time interval b between multiple pulses that may vary between 1 ms and 5000 s. The number of pulses per session may also vary from 1 pulse to 5000 pulses. The piston may be a solenoid, an electric motor, or a pneumatic or hydraulic piston. The pulses generated may be concealed or exposed to the eye during activation.

[0077] FIG. 10 is a front perspective view of a user wearing a device for stimulating the lacrimal and / or meibomian glands, generally referenced 1000, constructed and operative in accordance with a preferred embodiment of the disclosed invention. The device 1000 comprises a headpiece or mounting structure 1002 having coupling means 1003 for releasably coupling the mobile phone 1001 to the mounting structure 1002. The mobile phone 1001 includes a control unit, an optical system, a light source, and a power supply. The mounting structure 1002 is configured to be interconnected with the mobile phone 1001. Furthermore, the mounting structure 1002 is configured to receive the mobile phone such that the display screen of the mobile phone faces the user's eye. Additionally, the mobile phone uses a user-friendly app that allows the user to select the optimal treatment for their eye condition. Such an app can be a computer program or application software designed to run on a mobile device such as a mobile phone, a tablet, a smartwatch, etc. Furthermore, during operation, the app can be accessed and controlled by the user via a personal computer, another mobile phone, a tablet, or a smartwatch. The present invention relates in some embodiments to a kit for stimulating dry eye. In some embodiments of the present invention, a kit for stimulating the lacrimal and / or meibomian glands of a user's eye includes a device for stimulating the lacrimal and / or meibomian glands of a user's eye and a coupling means for releasably coupling the device to regular eyeglasses or sunglasses. In some embodiments, the device includes a controller and an optical system connected to the controller and arranged in a direction of the user's view. The optical system includes at least one light source and is configured to provide light stimulation pulses to the user's eye by the at least one light source, and the optical system includes a power supply for providing power to the controller and / or the optical system. The light stimulation pulses activate the pupillary light reflex and one or more reflexes selected from the blink reflex, the corneal reflex, the threat reflex, and the tearing reflex. When the device is in an operating mode, a light intensity gradient between the light pulses emitted by the at least one light source and the light around the eye is maintained at at least 2 lumens, and the light stimulation pulses induce the blinking of the user's eye.

[0078] In addition, in another embodiment of the present invention, a kit for stimulating the lacrimal gland and / or meibomian gland of a user's eye includes a device for stimulating the lacrimal gland and / or meibomian gland of a user's eye, configured as a headset configured to interconnect with and accommodate a mobile phone. In addition, the kit further includes an access code to a service provider. In operation, the service provider operates the mobile phone to emit light stimulation pulses to the user's retina to activate the pupillary light reflex and one or more reflexes selected from the blink reflex, the corneal reflex, the threat reflex, and the tearing reflex. When the mobile phone is in an operating mode, a light intensity gradient between the light pulses emitted by the at least one light source and the light around the eye is maintained at at least 2 lumens, and the light stimulation pulses induce the blinking of the user's eye.

[0079] Yet another embodiment of the present invention is a kit for stimulating the lacrimal and / or meibomian glands of a user's eye, comprising a mounting structure configured to fit the user's face and accommodate a mobile phone, and an access code to a service provider. In operation, the service provider manipulates the mobile phone to emit light stimulation pulses to the user's retina to activate the pupillary light reflex and one or more reflexes selected from the blink reflex, the corneal reflex, the threat reflex, and the tearing reflex. When the mobile phone is in an operational mode, a light intensity gradient between the light pulses emitted by the at least one light source and the light around the eye is maintained at at least 2 lumens. The light stimulation pulses induce a blink of the user's eye.

[0080] The present invention relates in some embodiments to a method of stimulating dry eye. In some embodiments of the present invention, a device can be utilized near a facial region of a user's eye to stimulate the lacrimal and / or meibomian glands of the user's eye. A caregiver or doctor selects a treatment plan for a particular user via an app in a mobile phone or computer. The treatment plan preferably allows for selection of a number of light pulses, a range of wavelength bands, and a time interval between light stimulation pulses. The method includes utilizing a device to stimulate the lacrimal and / or meibomian glands of a user's eye near a facial region of the user's eye. When the device is in an operational mode, the device emits light onto the retina. The emitted light activates a change in the chemical composition of the tear fluid, inducing intense meibum secretion. The device includes a controller and an optical system connected to the controller and positioned in a direction of the user's view. The optical system includes at least one light source and is configured to provide light stimulation pulses to the user's eye. A power supply for providing power to the controller and / or the optical system is also provided. The method further includes generating light pulses by at least one light source and emitting the light pulses toward the user's eye, activating one or more reflexes selected from a pupillary light reflex, a blink reflex, a corneal reflex, a threat reflex, and a tearing reflex, and inducing a blink of the user's eye. When the device is in an operational mode, a light intensity gradient between the light pulses emitted by the at least one light source and the light around the eye is maintained at at least 2 lumens. Furthermore, the light stimulation pulses induce a blink of the user's eye. The device operates without physical contact with the eye or eyelid.

[0081] Yet another embodiment of the present invention relates to a method for stimulating the lacrimal and / or meibomian glands of a user's eye, comprising: applying a light stimulating pulse near a facial region of the user's eye by emitting light to the retina; activating a pupillary light reflex and one or more reflexes selected from a blink reflex, a corneal reflex, a threat reflex, and a tear reflex; and activating a change in the chemical composition of the tears to induce vigorous meibum secretion. These steps are repeated as necessary to induce blinking of the user's eye. A light intensity gradient between the light pulse emitted by the at least one light source and the light around the eye is maintained at at least 2 lumens.

[0082] FIG. 11 provides a schematic flow chart presenting the therapeutic effect of light on dry eye according to one embodiment of the disclosed invention. Referring to FIG. 11, a light pulse source 1100 emits light to the retina to activate a chemical reaction (1101). The chemical reaction activates two parallel reflex mechanisms (1102): a brain reflex (1103) activated by the pupillary reflex and a somatic reflex (1104). Both reflexes (1103, 1104) cause vigorous activation of the lacrimal gland (1105), which produces excess tears. With the activation of the reflexes (1103, 1104), vigorous blinking occurs (1106). At the end of the process, the secretion of tears and meibum is reset (1107) due to the activation of multiple brain and somatic reflexes.

[0083] Some alternative methods may include any one of the following steps, or any combination thereof: shining light in the visible spectrum in the wavelength band 350 nm to 750 nm, operating a sound source alone or in combination with emitting light, applying vibrations to the user, disturbing eyelashes, activating a rotating element in the line of sight of the user, generating an airflow toward the user's eye, spraying water droplets toward the user's eye. In some embodiments, the method includes generating light stimulation pulses in a random pattern to prevent eye intolerance. Specifically, the light source generates light stimulation pulses in a random pattern that startles the user. In one or more embodiments, the optical system further comprises a lens, an adjustable lens, and / or a lens adjustment mechanism.

[0084] Those skilled in the art will appreciate that the disclosed invention is not limited to what has been particularly shown and described above. Rather, the scope of the disclosed invention is defined solely by the claims that follow.

Claims

1. 1. A device for stimulating the lacrimal gland and optionally the meibomian gland of a user's eye by emitting light to the retina, comprising: A control unit; an optical system connected to the control unit and arranged in a direction of the user's view, the optical system including at least one light source and configured to provide light stimulation pulses to the eye of the user by the at least one light source; a power supply device for supplying power to the control unit and / or the optical system; The light stimulation pulse induces a pupillary light reflex and Blink reflex, corneal reflex, threat reflex, lachrymal reflex, and activating one or more reflexes selected from When the device is in an operational mode, a light intensity gradient between the light pulses emitted by the at least one light source and the light around the eye is maintained at at least 2 lumens, and the light stimulation pulses induce a blink of the user's eye. Device.

2. The apparatus of claim 1 , wherein the controller is a personal computer, laptop, tablet, mobile phone, or microprocessor that is wired or wirelessly connected to the optical system.

3. 3. The apparatus of claim 1 or 2, wherein the power supply is integrated with or located within the optical system.

4. 3. The apparatus of claim 1 or 2, wherein the power supply is integral with or located within the control unit.

5. 3. The device according to claim 1 or 2, wherein the power supply is an external power supply connected to the control unit and / or connected to the device via an electrical wire.

6. 6. The device according to claim 1, further comprising coupling means for releasably coupling the device to a headset or to ordinary eyeglasses or sunglasses.

7. 7. The apparatus of claim 1, wherein the apparatus is configured as a headset configured to interconnect with and accommodate a mobile phone.

8. 8. Apparatus according to any one of the preceding claims, wherein the at least one light source emits light in the visible spectrum in the wavelength range from 350 nm to 750 nm.

9. 9. The device of claim 1, further comprising a sound source operable by the control.

10. 10. The apparatus of claim 1, further comprising a vibration source operable by the control unit.

11. 11. The device of claim 1, further comprising means for creating eyelash disturbance operable by said control unit.

12. 12. The device of claim 1, further comprising a rotating element positioned in the line of sight of the user and electrically connected to the power supply, the rotating element configured to allow light to pass through a lumen disposed on an outer surface of the rotating element toward the eye of the user.

13. 13. Apparatus according to any one of the preceding claims, further comprising means for providing an airflow towards the eye of the user.

14. 14. The device of claim 1, further comprising means for applying droplets of water towards the eye of the user.

15. 15. The device of claim 1, wherein the optical system further comprises a shading element operable by the control unit and powered by the power supply, the shading element configured to shade and unshade the user's eyes from light while the device is in the operational mode.

16. 16. The apparatus according to claim 1, further comprising a combination of at least two of a sound source, a vibration source, a means for creating turbulence of the eyelashes, a rotating element, a means for providing an air flow, a means for providing water droplets, and a light blocking element.

17. 17. The apparatus of claim 1, further comprising a camera that captures the response of the eye to the light stimulation pulses and transmits the captured data to the control unit for analysis.

18. 18. The device of claim 1, wherein the control unit is configured to interconnect with a virtual reality (VR) headset, an augmented reality (AR) headset, a mixed reality (MR) headset, or any other smart headset device that can be placed on the user's face.

19. 16. The device of claim 15, wherein the control unit is further programmed to interconnect with the smart headset device to display a sequence of photographs towards the user's eyes in a desired pattern that induces the user's eyes to blink.

20. 20. The device of claim 1, wherein the blink reflex and pupillary light reflex are activated without the device making direct contact with the eye or eyelid.

21. 1. A device for stimulating the lacrimal gland and optionally the meibomian gland of a user's eye by emitting light to the retina, comprising: A control unit; an optical system connected to the control unit and arranged in a direction of the user's view, the optical system including at least one light source and configured to provide light stimulation pulses to the eye of the user by the at least one light source; a power supply for supplying power to the controller and / or the optical system; Equipped with The light stimulation pulse induces a pupillary light reflex and Blink reflex, corneal reflex, threat reflex, lachrymal reflex, and activating one or more reflexes selected from When the device is in an operational mode, a light intensity gradient between the light pulses emitted by the at least one light source and the light around the eye is maintained at at least 2 lumens, and the light stimulation pulses induce blinking of the user's eye, which further induces meibum secretion, which induces tear production. Device.

22. 1. A kit for stimulating the lacrimal gland and optionally the meibomian gland in a user's eye, comprising: An apparatus according to any one of claims 1 to 6 and 8 to 21, coupling means for releasably coupling said device to ordinary eyeglasses or sunglasses; A kit comprising:

23. 1. A kit for stimulating the lacrimal gland and optionally the meibomian gland in a user's eye, comprising:

8. The device of claim 7 configured as a headset configured to interconnect with and accommodate a mobile phone; An access code to the service provider; Equipped with During operation, the service provider operates the mobile phone to emit light stimulating pulses to the retina and measure the pupillary light reflex and Blink reflex, corneal reflex, threat reflex, lachrymal reflex, and activating one or more reflexes selected from When the mobile phone is in an operational mode, a light intensity gradient between the light pulses emitted by the at least one light source and the light around the eye is maintained at at least 2 lumens, and the light stimulation pulses induce a blink of the user's eye.

24. 1. A kit for stimulating the lacrimal gland and optionally the meibomian gland in a user's eye, comprising: a mounting structure configured to conform to the user's face and receive a mobile phone; An access code to the service provider; Equipped with During operation, the service provider operates the mobile phone to emit light stimulating pulses to the user's retina to measure the pupillary light reflex and Blink reflex, corneal reflex, threat reflex, lachrymal reflex, and activating one or more reflexes selected from When the mobile phone is in an operational mode, a light intensity gradient between the light pulses emitted by the at least one light source and the light around the eye is maintained at at least 2 lumens, and the light stimulation pulses induce a blink of the user's eye.

25. 1. A method for stimulating dry eye by emitting light to the retina, comprising: Utilizing a device to stimulate the lacrimal gland and optionally the meibomian gland of the user's eye in the vicinity of a facial region of the user's eye, the device comprising: A control unit; an optical system connected to the control unit and arranged in a direction of the user's view, the optical system including at least one light source and configured to provide light stimulation pulses to the eye of the user by the at least one light source; a power supply for supplying power to the controller and / or the optical system; Utilizing the apparatus, generating light pulses with the at least one light source and emitting the light pulses toward the eye of the user; emitting light to the retina; activating the pupillary light reflex and one or more reflexes selected from the blink reflex, the corneal reflex, the threat reflex, and the tearing reflex; Inducing tear production; The method includes:

Images