Controller with imaging system

Abstract

To provide a dry eye treatment apparatus and methods.SOLUTION: Controllers for a dry eye treatment apparatus and methods are described herein which generally comprise a patch or strip affixed to the skin of the upper and / or lower eyelids to deliver heat to the one or more meibomian glands contained within the underlying skin. The one or more treatment strips include one or more strips configured to adhere to an underlying region of skin in proximity to one or both eyes of a subject such that the one or more strips allow for the subject to blink naturally without restriction from the one or more patches. A controller is in communication with the one or more strips and is programmable to monitor the temperature of the one or more strips to provide a treatment therapy above a threshold temperature of, e.g., 39°C, and below a maximum temperature of, e.g., 48°C, over a treatment period of 12 minutes.SELECTED DRAWING: Figure 44A

Description

Technical Field

[0001] The present invention relates to methods and devices for treating dry eye syndrome and other related symptoms. More particularly, the present invention relates to methods and devices having a programmable control unit for treating dry eye syndrome using an adhesive strip having a special outer shape or configuration adapted to adhere to a selected site around the patient's eye or orbit.

Background Art

[0002] Tears are a complex mixture of water, lipids, mucus, proteins, and electrolytes, which helps maintain a smooth, lubricated, optically transparent optical surface and also helps protect the eyeball from infection. The tear film has three basic layers: oil, water, and mucus. Any problems or disorders in these layers can cause problems on the surface of the eyeball, including dry eye symptoms.

[0003] The outermost layer of the tear film is usually composed of an oil layer (meibum) containing fatty acids and lipids. This oil layer is mainly formed by sebaceous glands called meibomian glands along the edge of the eyelid. The oil layer smooths the surface of the tears and prevents the evaporation of the aqueous or water-containing intermediate layer. However, if insufficient oil is secreted from the meibomian glands, an inappropriate fatty acid mixture is produced, or the meibomian glands become blocked or clogged, the water layer generally evaporates rapidly, resulting in dry eye. Obstruction and inflammation of the meibomian glands can cause gland hypertrophy, infections, thickening of secretions, hordeolum, chalazion, hordeolum, preseptal cellulitis of the orbit, etc. Thus, dry eye is often seen in people with impaired or reduced function of the meibomian glands. The above example is an example of meibomian gland dysfunction, also called evaporative dry eye.

[0004] The intermediate aqueous layer of the tear is mainly composed of an aqueous solution and is produced by the lacrimal gland and accessory glands (lacrimal glands). The intermediate layer cleans the eyeball, washes away foreign bodies and irritants, maintains a transparent optical medium, and keeps the surface of the eyeball moist. The innermost layer of the tear film is mainly composed of mucus, which helps to spread the tears evenly over the surface of the eyeball. Also, if there is a deficiency of mucus in the tear film, dry eye syndrome will occur.

[0005] As described above, the Meibomian gland is an oil-secreting gland that is present in both the upper and lower eyelids. There are about 30 to 40 glands along the upper eyelid and about 20 to 30 glands along the lower eyelid. The ducts of each gland open with fine pores along the inner edge of the free edge of each eyelid, from where the secretions are released, preventing adhesion between the eyelids and the surface of the eyeball. FIG. 1A shows an example of the arrangement of the Meibomian gland in a cross-sectional view of the upper eyelid UL, showing the relative positional relationship of one Meibomian gland MG. Other glands and anatomical tissue elements are shown for reference, for example, the Wolfring gland GW, the tarsal plate TR, the Moll gland GM, the Zeis gland GZ, the Krause gland GK, the upper lid flap UF, the conjunctiva CN, and the cornea CR of the eye partially covered by the upper eyelid UL are shown. As shown in the figure, the Meibomian gland MG is located along the length of the upper eyelid UL (and the lower eyelid LL), the duct opens along the inner edge of the eyelid UL, and it is close to the surface of the eyeball below.

[0006] FIG. 1B is a front view of the patient's eyeball with the upper eyelid UL and the lower eyelid LL closed, such as when the patient blinks. As shown in the figure, it can be visually recognized that the Meibomian glands MG are adjacent and arranged side by side with respect to both the upper eyelid UL and the lower eyelid LL. FIG. 1C is a perspective view showing the state of the patient's eye being open, showing how the Meibomian glands are normally relatively arranged when the patient's eye is open.

[0007] It is thought that blinking opens the pores of the meibomian glands and releases oily secretions from the meibomian glands. Through the natural blinking motion and the force of blinking, the upper eyelid draws a sheet of lipids secreted from the meibomian glands across the two lower layers of the tear film, forming a protective film and limiting the evaporation rate of the lower layer. At least 65% of meibomian gland diseases and dry eye are presumed to be caused by defects in the oil layer or insufficient amounts of such lipids, which promote the evaporation of the aqueous layer. Therefore, eyelid closure, blinking disorders, or other disorders that affect the proper distribution of tears can also cause or exacerbate meibomian gland dysfunction and dry eye.

[0008] When the eyelids close and a complete blink occurs, the upper and lower puncta, which are tear reservoirs, are compressed by the force of the preseptal muscle, and the eyelids move toward each other. For example, the upper eyelid moves to cover the eyeball while applying force on the surface of the eyeball, assisting in removing debris and insoluble mucin in front of the eyeball, and also squeezing out the oil secreted from the meibomian glands. The lower eyelid moves horizontally in the nasal direction, finally pushing out debris toward both puncta, which are openings that drain into the nasal cavity.

[0009] When the eyelids open, the tear film is redistributed. The upper eyelid draws the aqueous phase by capillary action, and the oil layer spreads rapidly in accordance with the movement of the eyelid. Therefore, the movement of the eyelids plays an important role in the regeneration, distribution, metabolic turnover, and drainage of the tear film.

[0010] For various reasons, blockage, congestion, inflammation, or obstruction of the meibomian glands can cause meibomian gland dysfunction and dry eye syndrome. The disorders that trigger the disease can occur anywhere in the meibomian glands. For example, on the surface or openings of the glands that prevent the flow of normal lipid secretions, in areas where the main ducts of the glands are narrowed or clogged, or in other deep parts of the glands connected to the main ducts.

[0011] There are several conventional treatment methods for treating clogged meibomian glands. One course of treatment is to apply soap and detergents, eyelid scrubs, antiseptics, or antibiotics to suppress eyelid inflammation. Antibiotics such as tetracycline, doxycycline, minocycline, metronidazole, azithromycin, bacitracin, and erythromycin can be administered orally or topically to regulate or improve the lipid production of the meibomian glands. In addition, inflammation on the ocular surface can be suppressed with topical medications such as anti-inflammatory compounds and immunosuppressants like corticosteroids and cyclosporine (RESTASIS® manufactured by Allergan, Inc. located in California). It has been suggested that inflammation on the ocular surface is associated with not only meibomian gland dysfunction but also dry eye syndrome.

[0012] Another example of a dry eye treatment is to apply a prescribed ocular insert for humans with moderate to severe dry eye symptoms who cannot use artificial tears. An ocular insert, such as hydroxypropyl cellulose (LACRISERT® manufactured by Merck & Co, Inc.), may be inserted between the lower eyelid and the eyeball. The insert slowly dissolves and releases a substance that lubricates the eyeball. Alternatively, there are methods to shield the surface of the eyeball and trap moisture by using special contact lenses or amniotic membrane transplantation.

[0013] In other treatment methods, the tear ducts may be closed by inserting tear plugs into the patient's tear ducts or cauterizing the tissue in the drainage area so that the tear film is not drained from the surface of the eyeball too quickly. In the treatment of dry eye syndrome, in addition to transplantation and cauterization therapy, medications such as eye drops and ointments for coating the eyeball may also be used. Artificial tears, gels, ointments, autologous serum tears, albumin eye drops, etc. are used in the treatment of dry eye.

[0014] In addition, it is used to place a warm compress over the eyeball to dissolve lipids and restore the function of the meibomian glands, or to massage the eyelids to further express the contents of the meibomian glands. However, warm compresses need to be performed two to three times a day. During that time, the patient may only target one eyelid of the affected area and may not be able to see the eyeball being treated due to the compress. Warm compresses have multiple problems such as non-compliance, low persistence, and high variability. There may also be cases where it is too hot and exacerbates inflammation, or too cold and the treatment effect cannot be obtained sufficiently.

[0015] In addition, treatment devices have also been developed that cover the entire affected area and directly apply heat and massage force to the eyelids of the affected area. However, similar to compresses, such devices need to temporarily but completely block the patient's eyeball during treatment, which may cause discomfort and a decrease in productivity, and may reduce the patient's compliance. In addition, since these treatment methods require going to a doctor or medical institution, they are time-consuming, inconvenient, and expensive, and as a result, they are not suitable for widespread dissemination to consumers.

Summary of the Invention

Problems to be Solved by the Invention

[0016] Therefore, there is a need for a method or device that can be used routinely by patients and doctors, is relatively simple, allows patients to continue their normal activities without interference, and can promote treatment by utilizing the patient's natural physiological activities.

Means for Solving the Problems

[0017] For the treatment of meibomian gland dysfunction, dry eye syndrome, etc., patches or strips can be attached to the skin of at least one of the upper and lower eyelids to supply heat, other forms of energy, cooling, light, ultrasonic waves, vibration, pressure, drugs, moisture, etc. (alone or in combination) to one or more meibomian glands contained in the underlying skin. In particular, the assembly of one or more treatment strips generally consists of one or more strips configured to be attached to a site under the skin adjacent to one or both eyes of the subject, and the subject can blink naturally without being restricted by one or more patches. Further, one or more strips may be configured to irradiate energy or treatment to a site under the skin, and one or more strips are formed in a shape along the position of one or more meibomian glands contained in the site under the skin.

[0018] The programmable control unit having a control board and a processor may communicate with one or more strips, and the control unit may induce, monitor, and provide a treatment therapy for the programmable temperature of one or more heater strips. The treatment therapy may be programmed to maintain a set point of a maximum temperature (e.g., 42 °C plus or minus 1 °C) that exceeds a threshold temperature of, for example, 39 °C and is less than, for example, 48 °C within a well-known accuracy over a treatment period of 12 minutes. In other treatment modalities, other treatment times may be implemented. For example, in other treatment modalities, the treatment time may be extended from 1 minute to 60 minutes.

[0019] In use, one or more strips are attached to the area of the skin near one or both eyes of the subject, and with these one or more strips, the subject can blink naturally without being restricted by one or more patches. In the attached state, the strip can treat the skin site or release energy, and one or more strips are shaped to follow the position of one or more meibomian glands included in the skin area. Alternatively, even if the strip does not directly cover the meibomian gland or other orbital glands, it may supply or absorb energy from the adjacent tissues and vascular system below it, and finally diffuse or supply it to the above glands. That is, using these strips to warm or cool the blood supply to at least any of the eyelids, meibomian glands, and lacrimal glands may affect their functions and metabolism, but it is not necessarily necessary to directly and excessively affect them in a specific manner.

[0020] Accordingly, the upper strip has an upper curved or arcuate peripheral edge that is shaped to extend along the upper (superior) boundary of the meibomian gland (along or up to the wrinkles of the upper eyelid), and the linearized peripheral edge of the lower edge may be shaped to extend along the free edge of the upper eyelid and along the lower (or inferior) boundary of the meibomian gland. Although linear, in another embodiment, the lower edge may be a gentle curve or arc. Similarly, the lower strip may have an upper linear peripheral edge that extends along the upper boundary line of the meibomian gland along the free edge of the lower eyelid, and a lower curved or arcuate peripheral edge that extends along the lower (or inferior) boundary line of the meibomian gland along the lower eyelid (along or up to the wrinkles of the lower eyelid, etc.). Alternatively, in another embodiment, the upper peripheral edge of the lower strip may also be gently curved or arcuate in the same manner.

[0021] That is, in the tarsal plate including the meibomian glands from the proximal to the distal, the outer peripheral edge of the treatment strip corresponds to the distal eyelid margin and the proximal peripheral edge, and the treatment strip can take a plurality of configurations. Generally, it has a distal outer peripheral edge and a proximal outer peripheral edge. The distal outer peripheral edge is relatively straight or has a gentle curve, and both can follow the distal eyelid margin and the tarsal plate below. The proximal outer peripheral edge is relatively curved assuming the more curved proximal edge of the tarsal plate below.

[0022] These strips can be individually used to be placed on only the upper eyelid or only the lower eyelid according to the purpose of the treatment. Furthermore, the length of the treatment strip can also be changed as needed to perform treatment targeted at individual meibomian glands, as described in more detail herein. In addition, the treatment strip may be of a general size, or can be customized or sized according to the dimensions of a specific human eyelid.

[0023] Due to the size and flexibility with a specific outer shape of the treatment strip, the treatment strip can be attached to the patient to treat the meibomian glands beneath it, and the patient can open and close their eyes normally without being obstructed by one or both treatment strips. Therefore, due to the size, shape, thickness, and flexibility of the outer shape of the treatment strip, one or both eyes of the patient can be kept open during the treatment, and the patient can perform normal and physiological blinks during the treatment. To further reduce the force applied to both eyelids, by adding a plurality of returns (for example, non-linear regions) to the connection path of the heater, the heater can be disconnected from the force applied to the connection part (such as a wire), and the load transmitted from the power cable to one or both eyelids can be made unstable. This treatment strip utilizes the natural mechanism of the eye to remove oil from the meibomian glands by blinking, rather than applying an external force. Therefore, the treatment strip can be adhered to a predetermined position for treatment without further intervention by the patient or medical staff, so that the treatment strip can, for example, apply thermal energy to melt or liquefy the wax-like or solid obstacles in the meibomian glands while the eyes are unobstructed and natural blinking is possible. In other treatment methods, the patient may be obstructed by closing their eyes during the treatment or may need to refrain from blinking, but with this treatment strip, the softened obstacles after heat treatment can be removed from the glands before they solidify again by the force of natural blinking.

[0024] The treatment strip may be configured to have a contact layer (e.g., formed from a conductive material such as metal, alloy, porous ceramics, engineering ceramics, wood, polymer, composite material, foam, polymer foam, cloth, elastomer, etc.), whereby the skin can be protected from burns and other adverse effects. The second heating layer is disposed on the contact layer (or in direct contact with the skin) to generate thermal energy, and the heat insulation layer is disposed on the heating layer to concentrate, direct, or reflect heat toward the underlying skin surface, and may also be disposed to protect the patient from other parts of the body coming into contact with the heating layer. The sensing layer can be disposed on or between any layer to perform monitoring and feedback of, for example, temperature, tissue impedance, muscle activity, etc. of the system or treatment. By using a plurality of sensors for any one heater and comparing them via the processor of the control unit, it is possible to determine the state, function, partial differences within the heater, differences between heaters, positional relationship with the patient, etc. The heat insulation layer can be formed using various heat insulation materials and reflective materials such as foam, foam tape, gauze, silicon, microporous polyethylene film, cloth, polymer, reflector, etc. for the purpose of delivering energy to the patient, maintaining the treatment target temperature, and suppressing fluctuations in treatment according to the surrounding situation. The heat insulation layer can have a heat load (capacity) targeted at a heat response time for the purpose of adjusting temperature changes. For example, with an increase in heat mass, the increase in heating and cooling times can be considered in the treatment procedure.

[0025] Although the application of thermal energy from the treatment strip has been described, as another variant, the application of cooling the underlying skin using the treatment strip can alternatively be included. Instead of using the heating layer of the exothermic reaction, the layer may be configured to cool the skin by using, for example, an endothermic reaction instead. Cooling can be performed instead of heating, especially during the patient's rest or sleep, in order to suppress inflammation, relieve allergies or eye fatigue. Also, electromagnetic energy such as light, mechanical energy, vibration, ultrasonic energy, etc. are examples of treatment methods that can be applied to the target tissue. The supply of energy may be carried out continuously or periodically.

[0026] Apart from the application of thermal energy from the treatment strip, the strip may include a layer for diffusing, directionally delivering, or releasing one or more pharmaceuticals, biological or chemical agents, either alone or in combination with a thermotherapy. For example, the agent, biological agent, or chemical agent can be incorporated into any of a contact layer, an insulating layer, or a completely separate layer and delivered transdermally to the meibomian gland or the area around the meibomian gland for at least one of additional treatment and alternative treatment. If a pharmacological or chemical agent is released during the thermotherapy, the heat may assist in improving the penetration of the agent into the underlying skin.

[0027] Although various different layers can be incorporated into the treatment strip to obtain various different treatment effects, as long as the outer shape or form of the treatment strip is formed along the position of at least one meibomian gland, the size, shape, outer form, etc. of the strip can also be changed according to the desired treatment area.

[0028] The treatment strip can be applied to one or more meibomian glands. However, a modified version of the strip can also be used to treat other glands such as sebaceous glands. For example, it can be used for acne treatment, cosmetic purposes, joint pain, muscle pain, wound healing, pain, inflammation, premenstrual pain, chest pain, and inflammation. Treatment strips for treating acne may utilize different pharmacological treatments. Furthermore, this treatment strip may also be used for treating eye diseases other than meibomian gland dysfunction.

[0029] As yet another example, there is the use of a treatment strip for treating disorders of the lacrimal gland located above the eye and / or the palpebral lacrimal gland that secretes tears. Treatment strips of various sizes, such as lacrimal gland strips, are sized to have a curved upper periphery and may be sized to be placed directly on the above-mentioned skin surface where the lacrimal gland is located. At least one of the lacrimal gland and the palpebral lacrimal gland that secretes tears may be treated alone or in combination with a treatment strip formed in an outer shape for treating the meibomian gland.

[0030] To apply thermal energy, the treatment strip may be applied over the meibomian gland. However, the treatment does not require an external force applied by the strip or other external devices, and the patient's natural blinking may be utilized to facilitate the treatment. However, in an additional modified version, the treatment strip may be configured to apply both thermal treatment and an external force. When performing thermotherapy, several mechanisms such as applying force by pinching or biasing to compress the underlying skin and meibomian gland can be utilized.

[0031] In addition to compressive force, alternative elements such as mechanical, sonic, ultrasonic, etc. can be used to form the strip, and by applying energy such as vibration energy, squeezing of the meibomian glands can be promoted, and extraction of oil can be facilitated. Alternatively, electromagnetic radiation such as visible light, red wavelength, infrared wavelength, etc. can also be irradiated as continuous or periodic treatment.

[0032] In yet another aspect, one or both of the treatment strips may be configured to incorporate an indicator, such as an LED light, an alarm, a vibration element, etc., that is electrically coupled to at least one of the power supply and the processor to warn the patient when a predetermined treatment is completed. This function (and any of the other functions) can be combined with any of the other variations of the treatment strip described herein according to practical applications.

[0033] By incorporating a processor and sensors into the treatment strip, parameters such as treatment time and strip temperature can be programmed, monitored, and optionally turned on / off by the patient selectively or automatically. Further, to provide additional flexibility in treatment and monitoring, other parameters such as heat supply, other stimuli, and treatment frequency can also be programmed by the processor.

Brief Description of the Drawings

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DETAILED DESCRIPTION OF THE INVENTION

[0035] For the treatment of meibomian gland dysfunction (MGD) and other causes of evaporative dry eye syndrome (DES), patches, strips, thin adhesive devices, etc. can be attached to the skin of at least one of the upper and lower eyelids to transfer or absorb heat, other forms of energy, pressure, drugs, moisture, etc. (alone or in combination) to one or more meibomian glands in the underlying skin. In particular, one or more treatment strips are configured and sized to be placed over one or more target meibomian glands in the skin of at least one of the upper and lower eyelids. Since the eyelids are generally the thinnest skin in the human body and the tissue is highly vascularized, thermotherapy such as heating or cooling can easily pass through the eyelids. Since the eyelid base is proximal and the eyelid margin is distal, the net flow of arterial blood is from proximal to distal. Therefore, no matter where these treatment strips are placed, heating or cooling treatment can be easily performed on the eyelids and any structures contained therein, such as meibomian glands MG, lacrimal glands LG, Zeis glands GZ, Moll glands GM, Wolfring glands GW, Krause glands GK, etc.

[0036] Furthermore, since the eyelids are quite thin, heating or cooling treatment is also transmitted to the surface of the eyeball and the eyeball itself (details will be described later). Therefore, energy can also be applied to the conjunctiva, goblet cells, episcleral vascular system, cornea, aqueous humor, iris, ciliary body, and in some cases, the retina, choroid, optic nerve, anterior vitreous, lens, etc. in this way. Thus, any thermotherapy with the treatment strip can also affect ocular surface diseases and anterior segment diseases, such as conjunctivitis, keratitis, corneal diseases, cyclitis, corneal diseases, glaucoma, cataract, etc., and can be used for the treatment of these diseases. Also, as detailed below, use in postoperative conditions such as LASIK, photorefractive keratectomy (PRK), cataract or corneal surgery, and other surgeries of the eyeball, periorbital area, intraocular, and eyelid is also conceivable.

[0037] As shown in the front views of FIGS. 2A and 2B, such a treatment strip according to one aspect is shown as being temporarily adhered to the upper eyelid UL and the lower eyelid LL above the eyes of the patient P in a closed state for purposes of explanation. The upper strip 10 with a formed outer shape is sized to be directly adhered to the skin of the upper eyelid UL, whereby the strip 10 is formed in a configuration and shape along the position of one or more Meibomian glands contained in the skin under the upper eyelid UL. Similarly, the lower strip 12 with a formed outer shape may have a configuration and shape along the position of one or more Meibomian glands contained in the skin under the lower eyelid LL. In another example, as described in the following alternative examples, the strip with a formed outer shape may stop at the eyelid wrinkles or cross over them.

[0038] Accordingly, the upper strip 10 has an upper curved or arcuate peripheral portion 14, which is formed in a shape extending along the upper (superior) boundary of the Meibomian gland (along or up to the eyelid wrinkles of the upper eyelid), and the linearized peripheral portion 16 of the lower edge may be formed in a shape extending along the free edge of the upper eyelid UL and along the lower (or inferior) boundary of the Meibomian gland. Similarly, the lower strip 12 may have an upper linear peripheral portion 20 extending along the upper boundary line of the Meibomian gland along the free edge of the lower eyelid LL and a lower curved or arcuate peripheral portion 18 extending along the lower (or inferior) boundary line of the Meibomian gland along the lower eyelid LL (along or up to the eyelid wrinkles of the lower eyelid, etc.). In this specification, the use of the terms lower and upper means the peripheral portion of the treatment strip when applied to the patient P (human or animal), and is used for purposes of explanation in this specification.

[0039] Treatment strips 10, 12 are each shown as being applied to the upper eyelid UL and the lower eyelid LL, but strips 10, 12 can be used individually by being applied to only the upper eyelid UL or only the lower eyelid LL, depending on the desired treatment. Further, the length of treatment strips 10, 12 can also be varied, as will be described in more detail herein, to perform a treatment targeted at individual meibomian glands, as needed.

[0040] Treatment strips 10, 12 are shown disposed on the closed eyelids of patient P, but strips 10, 12 may be arcuate or flexible, assuming the curvature of the edges of the patient's eyelids, and of a length sufficient to cover some or all of the meibomian glands beneath the tarsal plate. Treatment strips 10, 12 may be formed in a general size, but may also be formed in a custom size to fit the dimensions of a particular human eyelid, or in a shape that optimizes adhesion and / or comfort and / or stability. Generally, since the length of an adult eyelid fissure is about 27 mm to 30 mm, the length of treatment strips 10, 12 may range from about 1 mm to 50 mm, depending on the length of the desired treatment and considerations of the patient's anatomical tissues. Thus, treatment strips 10, 12 may be sized to have a length, for example, of 25 mm to 30 mm to cover as many meibomian glands as possible, or may be sized to have a length, for example, of 30 mm to 50 mm if sized to cover just beyond all of the meibomian glands (or more if necessary to optimize coverage / adhesion / comfort / stability). Further, one or both treatment strips 10, 12 may have a width in the range of about 1 mm to 25 mm. This is because typical eyelid wrinkles in white men are located about 8 mm to 9 mm above the edge of the eyelid, and in white women, about 9 mm to 11 mm above the edge of the eyelid (adhesion / comfort, and the ability to enhance the effect by heating or cooling the inflowing blood stream may allow for a greater width if necessary). By customizing, it can be adapted to the build, race, ethnicity, etc. Further, the treatment strips can be manufactured to have various levels of flexibility to fit the ergonomics of the eyelid and eyelid blinking, to obtain optimal comfort and minimize obtrusiveness and movement.

[0041] Due to the size and flexibility of the outer shape of the treatment strips 10, 12, the treatment strips can be worn by the patient P for the patient's own use as a consumer or worn by a healthcare worker on the patient for treating the underlying meibomian glands, whereby, as shown in FIG. 2B, the patient's eyes can open and close normally without being obstructed by one or both of the treatment strips. The strips are applied from the edge of the eyelid to the eyelid wrinkles, but can also bend or deform and / or compress in a bellows-like manner during blinking to prevent interference with normal blinking and to maximize comfort.

[0042] Typical treatment patches, such as warm compresses, are generally sized to be worn to cover one or both eyes so that the patient cannot open or blink their eyes during the treatment session. However, because there is a strong association between DES and MGD (e.g., MGD includes the spectrum of MGD, meibomian adenitis, blepharitis, chalazion), the natural blinking of a human is usually a mechanism by which meibomian gland secretions are released onto the edge of the eyelid and over the tears. When not blinking, the oil contained in the meibomian glands is not squeezed within the terminal ducts of the glands and does not contribute to the distribution of the oily layer over the tears.

[0043] Therefore, due to the size, shape, and flexibility of the outer shape of the treatment strips 10, 12, it is possible to keep one or both eyes of the patient open while performing the treatment, and the patient can blink normally and physiologically during the treatment. Instead of squeezing oil or obstacles out of the glands by applying an external force, the treatment strips 10, 12 can remove the oil from the Meibomian glands by utilizing the natural mechanism of the eyes through blinking. Therefore, the treatment strips 10, 12 can be adhered to a predetermined position for treatment without further intervention by the patient or medical staff, whereby the eyes are not obstructed and the treatment strips 10, 12 can, for example, apply thermal energy to melt or liquefy the wax-like or solid obstacles in the Meibomian glands while allowing natural blinking. In other treatment methods, the patient is obstructed by closing the eyes during the treatment or needs to refrain from blinking, but with these treatment strips 10, 12, the natural blinking force can assist in removing the heat-treated and softened obstacles from the glands before they solidify again. Also, since an increase in blood flow can affect metabolism, the temperature of other tissues, and inflammation, promoting tissue function and recovery, the supply of heat may promote vasodilation and increase blood flow.

[0044] Among patients, there are obstacles or blockages in the meibomian glands. If the temperature of the meibomian glands does not increase, these may not dissolve sufficiently, relax, or soften. Therefore, since the treatment strips 10, 12 can maintain the state of being worn on the patient during any period of the day, heat or other treatments can be applied to the surface of the eyelid for a considerable period at a relatively longer treatment time and a higher treatment temperature. The treatment strips may be relatively transparent or skin-colored so as to function properly throughout the treatment area and thereby not be conspicuous. The patient can go about their daily life while feeling the comfort of the treatment using the strips while opening their eyes and blinking. Furthermore, the patient can apply the treatment strips as many times as necessary, such as once a day, once a week, once a month, etc., until the symptoms of dry eye are cured. This improves the frequency and convenience of the treatment, and as a result, the effectiveness of the treatment can be enhanced.

[0045] Since the treatment time is long, as long as the patient can continue to blink during the treatment, there will be no need to apply any other force other than sticking the strip. Furthermore, the treatment frequency can be adjusted or changed according to the severity of the symptoms to be treated. An example of a potential treatment frequency is, for example, up to 6 times a day, a 10-minute treatment, or the application of one or both strips for up to 1 hour or more for each treatment. Additionally, since the treatment strips are placed on the meibomian glands overlapping the surface of the eyeball, by performing thermotherapy, the surface of the eyeball can also be indirectly heated, and any chronic inflammation of the surface of the eyeball, chronic conjunctival inflammation, or corneal neovascularization may be further reduced.

[0046] Also, not only can the eye surface be heated, but it is also possible to optionally perform thermotherapy to suppress inflammation and neovascularization, which are the underlying symptoms of diseases such as age-related macular degeneration (AMD), retinal vascular occlusion, retinal neovascularization, glaucoma, retinal degeneration, retinal dystrophy, and diabetic retinopathy, by potentially heating indirectly from the eye surface or heating the retina.

[0047] The treatment strips 10, 12 can be used throughout the day to utilize the patient's physiological blinking, but the treatment strips 10, 12 can also be used while the patient is resting, sleeping, or simply with eyes closed. The treatment strips 10, 12 can be applied as a single - use treatment or can be configured to have sufficient robustness as a reusable device.

[0048] The treatment strips 10, 12 desirably have sufficient flexibility to accommodate movement of at least about 15 mm or more of at least one of the upper eyelid UL and the lower eyelid LL. Thus, the treatment strips 10, 12 can be made from a variety of materials. FIGS. 3A and 3B respectively show a front view and a side cross - sectional view of an example of a treatment strip configured such that an adhesive 32 is disposed around the peripheral edge of the strip to leave a contact area 30 for direct placement on the skin surface. The contact area 30 may further include a moisturizing layer that forms an interface between the strip and the skin to promote heat transfer from the strip and to apply a moisturizing treatment to the skin. Alternatively, the treatment strip can be used in combination with any number of moisturizing agents that the patient P or medical staff apply to the underlying skin separately from the treatment strip. Further, the contact area 30 may be formed to have a surface such as smooth, porous, irregular, corrugated, etc. to facilitate contact and heat transfer from the treatment strip to the skin surface. Alternatively, to maintain good contact, the entire contact area 30 including its periphery may be used as an adhesive. Also, by making it hinge - type or curve - type, it enables dynamic movements such as bending and telescoping like a bellows, realizing comfortable and physiologically excellent ergonomics. During use, to reduce the interference of blinking, as shown by the tensioned strip 10' in FIG. 3D, after the strip is attached to the skin in a tensioned state, to facilitate the patient P's blinking, as shown by the released strip 10'' in FIG. 3D, the strip can be released and bent.

[0049] In this aspect, the treatment strip 10 may be configured to have a contact layer 34 (e.g., formed from a conductive material such as metal, alloy, porous ceramic, engineering ceramic, wood, polymer, composite material, foam, polymer foam, elastomer, etc.) that can protect the skin from burns and other adverse effects. Also, such a contact layer 34 may be composed of a single-use adhesive layer, a soft adhesive polymer material, or the like. The second heating layer 36 is disposed on (or in direct contact with) the skin to generate thermal energy, and the heat insulation layer 38 is disposed on the heating layer 36 to concentrate, guide, or reflect heat toward the underlying skin surface, and may also protect the patient from contact with the heating layer 36 from other parts of the body. The heat insulation layer or reflective layer 38 is composed of various heat insulation or reflective materials such as foam, foam tape, gauze, silicon, microporous polyethylene film, metal, alloy, reflector, mirror, etc. Further, the thickness of the treatment strip 10 varies in a range of, for example, about 1 / 64 inch to 1 / 8 inch (about 0.397 mm to 3.175 mm) or more according to the mechanism of the heating layer 36, the desired heat profile, and the target transmission temperature. Additionally, and / or alternatively, the heat insulation layer 38 is composed of a thermochromic material, which can change its color when the treatment strip 10 reaches the target temperature, indicating to the patient that the target temperature has been reached and the treatment is complete. When the heat insulation layer 38 is provided, due to the increase in heat mass, treatment considering the increase in heating and cooling times is required.

[0050] The heating layer 36 may be configured to generate its thermal energy by any number of various mechanisms such as mechanical, electrical, or chemical mechanisms, for example, up to a temperature range of about 20°C to 55°C (or higher) or 40°C to 50°C. In one aspect, the heating layer 36 may be composed of an air-activated or oxygen-activated heater that can be raised to an elevated treatment temperature for a period, for example, of 5 minutes to 24 hours, or longer. As an example, an air-activated layer containing, for example, iron may be mentioned. As another example, there is a heating layer 36 provided with cellulose, iron powder, water, activated carbon (to accelerate the reaction), vermiculite (to store water), salt (catalyst), sawdust, sodium chloride, water, etc., which generates heat by oxidation due to the exothermic reaction of iron when exposed to air. As other aspects, there is a heating layer 36 using light activation (powered by visible light or UV light) or a supersaturated solution (crystallization type) to perform at least one of starting and maintaining an exothermic reaction.

[0051] Optionally, in addition to using a thermochromic material to determine when the treatment strip has reached a specific temperature, as shown in FIG. 3B, individual temperature sensors 39 (e.g., thermocouples or thermistor devices) may be incorporated into the treatment strip 10 and attached to the top or bottom of the strip. As shown in FIG. 3C, the treatment strip 10 may incorporate at least one of any control unit and display 37 having a programmable processor, or may incorporate an individual on / off function. One or more temperature sensors 39 can communicate with the control unit 37, and the control unit is programmed to adjust the temperature of the heating layer 36 and / or the length of time for a specific treatment. The sensor can provide the control unit with data indicating regional variations in temperature. This improves the ability to stay within the treatment window and can notify the user of suboptimal wearing conditions or peeling of the heating strip. Multiple temperature sensors can be used to determine the accurate application of the strip to the patient. For example, sensors not in contact with the patient will record different temperatures compared to sensors in contact with the patient. The control unit 37 can be directly programmed by a physician, caregiver, or patient. Alternatively, the control unit 37 may be configured to be inaccessible to the patient and only display at least one of the temperature and time for display to the patient. If the control unit 37 is programmable, the control unit 37 can be programmed, for example, to set the length of the heating period, set the treatment time, set a predetermined temperature range, control the heating temperature profile (gradually increase the heating temperature or decrease the temperature over a predetermined time, etc.).

[0052] In another example, the heating layer 36 may generate heat by exothermic crystallization of a normally reusable supersaturated solution (typically sodium acetate). The treatment strip can be recharged by heating, for example, by boiling, and then cooling. Heating of this treatment strip can create a nucleation center for initiating crystallization by snapping a small metal device embedded in the treatment strip. Heat is required to dissolve the salt in water, and this heat is released when crystallization is initiated.

[0053] In yet another aspect, the heating layer 36 may be constituted by a battery-powered heater that utilizes an electrical resistance heating element used to convert electrical energy in the battery into thermal energy. The power source may be inside or outside the treatment strip, and the treatment strip may be charged, for example, by direct electrical contact, induction, or the like.

[0054] Also, as another mechanism incorporated into the heating layer 36, a chemically activated reaction such as that seen in a heating pad of sodium acetate can be considered. For example, a single-use chemical reaction that rusts iron with a catalyst or dissolves calcium chloride can be used when the reagents are maintained in individual compartments within the treatment strip. When the patient squeezes the treatment strip, the partition breaks and the reagents mix, generating heat. For example, using a supersaturated solution of sodium acetate (NaCH3COO) in water, crystallization can be caused by bending a small flat disk of notched iron metal embedded in the liquid, which can function as a nucleation site for the crystallization of sodium acetate into its hydrated salt (sodium acetate trihydrate). Since the liquid is supersaturated, the solution crystallizes rapidly, thereby releasing the energy of the crystal lattice.

[0055] Yet another example for use in the heating layer 36 is the use of a hot gel containing a supersaturated solution of a salt. Heat can be generated when crystallization of a given salt occurs with heat evolution. Such a heating layer 36 can be reused by forcing the salt back into solution within the heating layer 36.

[0056] Furthermore, as an additional material for the heating layer 36, a material with a high specific heat can also be used. The material with a high specific heat can be heated, for example, by placing it in a microwave oven before use, and heat can be released over a predetermined period of time.

[0057] Although the application of thermal energy from the treatment strip has been described, as an alternative aspect, an application of using the treatment strip to cool the underlying skin can be cited. Instead of using the heating layer 36 for an exothermic reaction, an endothermic reaction can be utilized instead to configure the layer to cool the skin, for example, in a temperature range of about 0°C to 37°C, more specifically about 25°C to 35°C. As an example, water and ammonium nitrate or ammonium chloride can be included in layer 36. The temperature of layer 36 can be reduced by the mixture of water and ammonium. In another example, a cooling gel added with hydroxyethyl cellulose or vinyl-coated silica gel can also be used, but these are cooled or frozen before use. Instead of this, a cooling element such as a Peltier junction can be used to perform cooling including thermoelectric cooling, but it is not limited to this. Cooling can be performed instead of heating, especially during the patient's rest or sleep, such as reducing inflammation and swelling, alleviating allergies and tired eyes. As an example, in the treatment of allergic conjunctivitis, by performing a cooling treatment, blood flow can be restricted as a vasoconstrictor drug, the leakage and permeability of blood vessels can be reduced, and acute swelling and inflammation can be suppressed, thereby alleviating flushing and itching. As a further alternative example, it can include reducing the inflammation and fibrosis of conjunctival filtration blebs resulting from trabeculectomy, or reducing the inflammation generally occurring after any ophthalmic disease or surgical procedure or treatment around the eyeball.

[0058] Since there are a plurality of various mechanisms for incorporating the heating layer 36, the treatment strip may be configured as a single-use disposable strip, a multi-use disposable strip, a reusable strip, a selectively activatable strip, and the like.

[0059] Separate from the application of thermal energy from the treatment strip, the strip may further include a layer for diffusing or releasing one or more pharmaceuticals, biological agents, or chemical agents, either alone or in combination with heat treatment. For example, the pharmaceutical, biological agent, or chemical agent may be incorporated into either the contact layer 34, the thermal insulation layer 38, or a completely separate layer, and is transdermally delivered to the meibomian gland or the area surrounding the meibomian gland for at least one of additional treatment and alternative treatment. For example, some examples of various pharmacological agents that can be incorporated into the treatment strip (for use with or without thermal treatment) include anti-inflammatory compounds, antibiotics, topical tetracycline, oral tetracycline, topical corticosteroids, oral corticosteroids, topical androgens, metronidazole, steroid antagonists, topical androgen-like compounds, TGF-β, omega-3 or omega-6 compounds, naphazoline, oxymetazoline, phenylephrine, tetrahydrozoline and other vasoconstrictor nerve agents, enzymes that promote lipid production, agents that stimulate the production of enzymes that promote lipid production, agents that function as secretagogues to promote the secretion of the meibomian gland, agents that replace or promote the production of any tear component, cholinergic agents, muscarinic agents, the use of nicotinic agents, pharmaceutical cosmetics such as retinol and hyaluronic acid (HA) for wrinkled, puffy, or sagging skin in the cosmetic field, retinoic acid for acne, or agents that decompose or destroy lipids such as lipase, but are not limited thereto.

[0060] Other agents include, for example, androgens such as alpha-melanocyte stimulating hormone, adrenocorticotropic hormone, or testosterone that enhance tear production, agents that stimulate the muscles under the orbicularis oculi muscle and the Riolan muscle to increase the number of blinks to promote blinking, or agents that suppress the levator palpebrae muscle to force blinking or eyelid closure, thereby maintaining the closure after blinking for a longer time, or agents that mechanically compress goblet cells and accessory lacrimal glands such as the meibomian gland and Zeis gland.

[0061] In addition to and / or in place of this, other agents incorporated into the treatment strip can further include, for example, neurotransmitters, harmful or irritating chemicals or vapors, hormones, oils, lipids, polar lipids, or fatty acids. By using neurotransmitters, activation of the calcium / protein kinase C pathway, activation of G proteins, other calcium-related pathways, calcium-calmodulin-dependent protein kinases, cyclic adenosine monophosphate-dependent pathways, activation of the adenylate cyclase pathway, inhibition of cAMP-dependent phosphodiesterase, etc., stimulation can be given through the second messenger pathway.

[0062] If a pharmacological or chemical agent is released during heat treatment, it may be assisted that the penetration of the agent into the underlying skin by heat is improved.

[0063] As yet another aspect, a heat lamp for treating Meibomian glands by attaching to at least one of the upper eyelid UL and the lower eyelid LL through a treatment strip, or a treatment strip for applying a compound that attracts and heats light, can also be mentioned. With each of these aspects, by attaching and using the treatment strips 10, 12 while allowing natural blinking, it is possible to remove the blockage of the melted oil in the Meibomian glands from the duct and make it easier for the oil to spread into the tears.

[0064] Treatment strips can incorporate various layers into the strip to obtain various different treatment effects. However, as long as the outer shape or form of the treatment strip is formed along the position of at least one meibomian gland, the size, shape, outer form, etc. of the strip can also be varied according to the desired treatment area. A front view of Figure 4 shows another configuration example of the treatment strip, showing a thin strip 40 with an outer form formed to be sized and shaped to be disposed along the upper eyelid UL. This treatment strip has an outer form of a lower edge 42 and an upper edge 44, which are along the position of the meibomian gland thereunder. Further, although the strip 40 is shown to be disposed on the upper eyelids UL of both eyes of the patient P, one strip 40 can be used on one eyelid to selectively treat a specific meibomian gland in this and other examples shown herein. In addition, one or both upper eyelids UL alone, or in combination with one or both lower eyelids LL, can be treated according to the desired treatment in this and other examples shown herein.

[0065] Figure 5 shows a front view of another example, which shows a thick strip 50 with an outer form. This strip has a lower edge 52 with an outer form and an upper edge 54 with an outer form, which are for attachment to the meibomian gland and the surrounding tissues and glands. As yet another aspect, instead of using two separate treatment strips, one strip covering the patient's nasal bridge can be used. In addition, the thick strip 50 can cover a portion of the skin spaced proximally from the eyelid margin for easy treatment. Since the arterial blood supply to the eyelid proceeds from the proximal side to the distal side of the eyelid margin, the treatment strip can heat (or cool) the blood supply that continues to flow towards the eyelid margin. By heating (or cooling) early in this way, treatment effects such as improvement of the patient's comfort, reduction of the impact on eyelid functions (such as blinking), improvement of safety during use, and increase in the distance from the ocular surface can be obtained, and more comprehensive heating and cooling treatments become potentially possible.

[0066] Figure 6 shows a thin strip 60 with an outer shape according to another example, where the lower edge 62 and the upper edge 64 converge to an end portion 66 that becomes thinner towards the tip. This strip is for attachment to the meibomian gland. Figure 7 shows, in yet another example, an aspect in which a treatment strip is configured to be used in combination with a linear strip 70 having a first width and a thin linear strip 72. The linear strip 70 may be composed of linear strips (optionally having rounded corners), and these may be selectively arranged to cover the meibomian gland. In this example, one linear strip 70 is affixed on the upper eyelid UL of one eye, and for the other eye, one linear strip 70 affixed along the first portion of the upper eyelid UL and a second linear strip 72 having a relatively thinner width arranged on the second portion of the upper eyelid UL can be utilized. Each strip can be affixed singly or in various combinations according to the desired treatment area, and is shown as an exemplary combination in this aspect.

[0067] In the aspect of Figure 8, an example is shown where a thin strip 80 with an outer shape is affixed along the lower eyelid LL. As shown, the upper edge 82 forming the outer shape and the lower edge 84 forming the outer shape are shaped to run along the underlying meibomian gland. As described above, the treatment strip may be affixed singly to one or both eyes, or may be affixed in combination with a treatment strip affixed on one or both eyes of the upper eyelid. Further, any of the treatment strips shown in this specification can be used in any number of combinations with each other.

[0068] FIG. 9 shows another example in which a thick strip 90 with a formed outer shape, which is relatively wider than the treatment strip shown in FIG. 8, is attached to cover the lower eyelid LL. Similarly, FIG. 10 shows a further example in which a thick strip 92 with a formed outer shape is relatively wider to treat not only the lower meibomian glands but also the glands and tissues of the areas around the eye socket. As described above in the embodiment of FIG. 5, the treatment strip formed wide may heat (or cool) the blood as the blood continues to flow toward the eyelid margin. By early heating (or cooling), treatment effects such as improvement of patient comfort, reduction of influence on eyelid function (such as blinking), improvement of wearing safety, and increase in distance from the eyeball surface can be obtained.

[0069] Not only by changing the width of the treatment strip, but also by changing the length of the treatment strip, a part of the meibomian glands or particularly selected meibomian glands can be selectively targeted. For example, FIG. 11 shows an aspect of applying a shortened strip 100 with a formed shortened outer shape having a first shortened length onto the lower eyelid LL (and / or the upper eyelid UL). A second strip 102 with a formed second outer shape having a second length longer than the shortened strip 100 with the formed outer shape is also shown for comparison. FIG. 12 similarly shows a short straight strip 110 applied onto the lower eyelid LL and a second straight strip 112 with a relatively longer length applied onto a second lower eyelid LL. The straight strips 110, 112 may incorporate rounded ends and may have their lengths changed according to the desired treatment site. Also, for covering one or more styles, they may be in a rounded or circular shape.

[0070] FIG. 13 shows, in a further example, an aspect in which the end of a strip 120 with a formed outer shape is provided to be thinner toward the tip and configured to cover the meibomian glands. In comparison, a thick strip 122 with a formed outer shape has its end provided to be thinner toward the tip but is relatively wider to change the treatment site.

[0071] FIG. 14 shows an embodiment in which, in another example, the strip 130 with the formed outer shape has a first portion 132 that is relatively wider than a second portion 134 for arranging to cover the meibomian glands of the lower eyelid LL. The widths of the first portion 132 and the second portion 134 can be changed again according to the desired treatment site. FIG. 15 shows another example, and this figure shows a strip 140 with a formed outer shape having a first portion 142 and a second portion 144 that are considerably wider to treat not only the meibomian glands along the lower eyelid LL but also the surrounding orbital tissue regions such as the maxillary sinus below it. FIG. 16 shows a strip 150 according to yet another example with a formed outer shape having a first portion 152 and a second portion 154 that is wider than the first portion 152. The strip 150 is arranged to cover only a part of the meibomian glands along the lower eyelid LL, but also covers various other glands such as the lacrimal gland in the orbital region.

[0072] FIG. 17 shows a treatment strip according to yet another example in which a secondary enlarged portion 162 is attached to the strip 160 with the formed outer shape via a connecting strip 164. The strip 160 with the formed outer shape can treat the meibomian glands along the lower eyelid LL, while the secondarily enlarged portion 162 can treat the tissue site along the patient's cheek.

[0073] As yet another alternative example, FIG. 18 shows an example in which both a strip 170 forming an upper outer shape and a strip 172 forming a lower outer shape are respectively attached along the upper eyelid UL and the lower eyelid LL. As described above, the strips 170, 172 forming the outer shape are formed and attached in a shape along the underlying meibomian glands while allowing the patient P to blink normally. FIG. 19 shows a strip 180 forming an upper outer shape and a strip 182 forming a lower outer shape that are similarly attached, and the strips may be colored to more closely match the skin color or shade of the patient P. Since the treatment strips may be used throughout the day for any period, the strips 180, 182 may be formed in various colors or color tones to be closer to the skin color or shade of the patient P.

[0074] As yet another aspect, FIG. 20 shows another example in which the length of the treatment strip can be varied to treat specific sites along the upper eyelid UL or the lower eyelid LL. In this example, a first upper strip 190 having a first length may be applied adjacent to a second upper strip 192 having a second length that is longer than the first. Optionally, a third upper strip 194 and / or a fourth upper strip 196 having a relatively short length may also be similarly applied over the selected meibomian glands. Also shown is a lower strip 198 having enlarged distal ends 200, 202 for placement along the lower eyelid LL. The distal end 200 may be shaped (or better adhered) such that the strip 198 can be easily placed on and / or removed from the skin. FIG. 21 shows yet another alternative example, which illustrates that several shortened treatment strips, such as a first upper strip 210 and a second upper strip 212, are selectively arranged along the upper eyelid UL, and also, for example, a first lower strip 214 and a second lower strip 216 are selectively arranged along the lower eyelid LL. Each strip can be changed in length and size according to the treatment site.

[0075] Since the length of the treatment strip is variable, a plurality of strips can be attached adjacent to each other, or can be attached overlapping along at least one of the horizontal and vertical directions along the eyelid. Further, one or more treatment strips may be formed as a single unit, or as a series of panels oriented in either the horizontal or vertical direction, and these panels may optionally be connected by a flexible backing. As shown in the embodiment of FIG. 22, each of the target strips 220 may have a length of, for example, about 1 mm in order to cover only one meibomian gland. One or more of the target strips 220 may be attached along at least one of the upper eyelid UL and the lower eyelid LL. Additionally, one or more of the target strips 222 may further include a connecting member 224 that functions as a backing for joining the individual target strips 222 to each other. These individual strips can be selectively attached along at least one of the upper eyelid UL and the lower eyelid LL, particularly to the problematic meibomian glands. For example, FIG. 23 shows individual target strips 222 arranged only along the lower eyelid LL.

[0076] The treatment strip can be attached to one or more meibomian glands, but a variant of the strip can also be used, for example, for acne treatment, to treat other glands such as sebaceous glands. Treatment strips for treating acne can utilize different pharmacological treatments. Other glands in the eyelid and conjunctiva CN under which the treatment is performed may also further include, for example, the Zeis gland GZ, goblet cells, accessory sebaceous glands, accessory goblet cells such as the Henle gland and the Manz gland, accessory lacrimal glands such as the Wolfring gland GW and the Krause gland GK, or treatment of one or both lobes of the main lacrimal gland in the eyelid part or the orbital part.

[0077] Furthermore, the treatment strip can be used to potentially treat eye disorders beyond meibomian gland dysfunction, such as, for example, blepharitis, Sjogren's syndrome, dacryoadenitis, conjunctivitis, allergic conjunctivitis, dry keratoconjunctivitis, keratitis, dacryocystitis, iritis, keratitis, retinitis, sclerokeratitis, uveitis, eye problems related to contact lenses, after blepharoplasty, after surgical procedures on the eyelid or eyeball (e.g., cataract surgery, LASIK, PRK, etc.), lack of blinking, blinking disorders due to dysfunction, conjunctivitis, blepharospasm, lagophthalmos, corneal epithelial detachment, recurrent corneal erosion, corneal dystrophy, facial nerve paralysis or paresis, lagophthalmos, myokymia of the eyelid, infections, chalazion, hordeolum, glaucoma, blisters, trauma, etc.

[0078] As yet another example, as shown in FIG. 24, the treatment strip can be used to treat a disorder of at least one of the lacrimal gland LG and the tarsal gland PL located on the eyeball. Treatment strips of various sizes formed to have a curved upper outer shape, such as the lacrimal gland strip 230 shown in FIG. 25, can be formed to a size that can be directly placed to cover the skin surface above where the lacrimal gland LG is located. FIG. 26 shows a lacrimal gland strip 232 with a relatively narrow width, and FIG. 27 shows a lacrimal gland strip 234 with a curved outer periphery and a tapered tip, but these are other variations. The treatment strip may, for example, transfer heat in order to stimulate the lacrimal gland LG and increase the metabolism, activity, and tears of the lacrimal gland. Alternatively, the treatment strip can also perform cryotherapy to suppress inflammation that impairs the function of the gland.

[0079] At least one of the lacrimal gland LG and the tarsal gland PL can be treated alone or in combination with a treatment strip formed with an outer shape for the treatment of the meibomian gland. FIG. 28 shows a strip 240 formed with an outer shape according to one aspect, widened in width to cover both the meibomian gland and the lacrimal gland LG along the upper eyelid UL. Also, as shown in the figure, a treatment strip 242 formed with an outer shape is disposed along the lower eyelid LL to also perform treatment of the meibomian gland.

[0080] Figure 29 shows another example where the lacrimal gland strip 250 can be arranged to cover the lacrimal gland LG in combination with an integrally formed composite outer-shaped strip 252 sized to completely surround the eye while checking the position of the meibomian glands along both the upper eyelid UL and the lower eyelid LL. This completely surrounding configuration can also be more firmly held against the skin with a strap that surrounds the patient's head, if desired. Another example is shown in Figure 30, which shows an integrally formed outer-shaped strip 260 sized to completely surround the eye and having a width suitable for placement over the lacrimal gland LG as well.

[0081] The lacrimal gland strip 270 may be used in combination with any of the treatment strips disclosed herein. Also, Figure 31 shows, in another example, a configuration in which the lacrimal gland strip 270 is combined with a separate strip 222, and Figure 32 shows a configuration in which the lacrimal gland strip 270 can be used in combination not only with the strip 222 but also with strips 220 arranged along the lower eyelid LL and the upper eyelid UL.

[0082] To apply thermal energy, the treatment strip may be applied over the meibomian glands, but the treatment does not require the application of an external force applied by the strip or any other external device, and as described above, the patient's natural blinking may be utilized to facilitate the treatment. However, in an additional aspect, the treatment strip may be configured to apply both heat treatment and an external force. When performing thermotherapy, several mechanisms for pinching or biasing to compress the underlying skin and meibomian glands can be utilized. An example is shown in the front view of Figure 33, which shows a biased treatment strip 280 composed of the strip 282 as described above and having one or more biasing mechanisms 284 arranged along the strip 282. The one or more biasing mechanisms 284 may be arranged along either, or both, the upper strip or the lower strip, as shown.

[0083] In this example, by pressing the skin where the biasing mechanism 284 is locally downward, pressure can be applied to the meibomian gland MG to easily remove obstacles, especially when applied simultaneously with a heat treatment. A perspective view of an example of the biasing mechanism 284 is shown in FIG. 34, which shows that the biasing mechanism 284 is generally composed of a part 282 of the strip or is composed of individual members biased to form corresponding channels 286 that bend in an open and closed form. When initially placed on the skin, both ends of the strip can be pulled to open the channel 286 and it can be placed on the surface of the skin. When the strip and the biasing mechanism 284 relax, the underlying skin and the meibomian gland MG may be compressed or pinched by the compressive force 288 induced in the biasing mechanism 284. For example, by changing the current flowing through the nitinol wire and changing the length of the wire when the current is flowing, a compressive force can be applied. In addition, the wire can also be used to fix the strip to the eyelid or apply a compressive force.

[0084] In addition to the compressive force, by forming the strip using alternative components such as mechanical components that impart vibrational energy, the squeezing of the meibomian gland can be promoted and the secretion of oil can be facilitated. FIG. 35 shows an example, showing an aspect in which strips 290A, 290B with an outer shape according to another example have one or more vibration elements 292 (e.g., piezoelectric transducers, electromagnetic actuators, rotation elements coupled eccentrically, etc.) incorporated along the strips 290A, 290B. The one or more vibration elements 292 may be electrically coupled to at least one of a power source and a processor 294 included along the strips 290A, 290B. Further, the vibrational energy may be applied separately from or in combination with the thermotherapy. The power source may include a rechargeable microbattery to supply energy of a microcurrent. Such a microbattery can be incorporated into the strip or incorporated individually.

[0085] In addition to vacuum, suction, mechanical pressure, or the application of vibrational energy, other forms of energy can also be provided by one or more treatment strips. A further example is shown in FIG. 36, where strip 300A with an upper profile has a conductive element 302, such as a wire, integrally formed along the entire length (or a partial length) of strip 300A with the profile. The conductive elements 302 may be configured alternately or may simply be arranged along the length of the strip as indicated by conductive element 306 (or electrical resistance) along strip 300B with a lower profile. Each conductive element 302, 306 may be in electrical communication with at least one of the corresponding power source and processor 304, 308. The conductive elements 302, 306 may be selectively activated to apply thermal energy or may be configured to apply radio frequency (RF) energy, visible light, or a particular band or wavelength thereof, or infrared radiation to the underlying skin and meibomian glands. With regard to the application of electrical energy, one form of electrical energy applicable by the treatment strip can include, for example, the use of a transcutaneous electrical nerve stimulation function to provide nerve stimulation to increase tear production. The conductive elements can generate thermal energy via various power sources, such as batteries, solar cells, motion, RF, etc.

[0086] FIG. 37 shows another example configured to incorporate an electrode or antenna 312 coupled to at least one of a power supply and a processor 314 onto the outer-shaped strips 310A, 310B for applying, for example, microwave energy to the meibomian glands below. Separate from electrical energy or microwave energy, the treatment strip may be configured to apply other forms of energy for treating the meibomian glands. For example, as another aspect, an actuator or transmitter for applying ultrasound, RF, microwave, magnetic, photon (light energy in the infrared or visible light spectrum), ultrasound power supply by a receiver such as a piezoelectric receiver, electromotive force or electromagnetic radiation power supply, heat, etc. may be incorporated. As yet another aspect, the conductive element may be configured to function as an electromagnetic element once activated, or the strip may incorporate a ferromagnetic element for promoting eyelid closure. The magnetic force plays a role in compressing the meibomian glands and squeezing out oily obstructions by overcoming the magnetic force to open or reopen both eyes.

[0087] In yet another example, one or both of the treatment strips 320A, 320B may be configured to incorporate an indicator 324, such as an LED light, an alarm, a vibration element, etc., electrically coupled to at least one of a power supply and a processor 322 for warning the patient when a predetermined treatment is completed. This function (and any of the other functions) can be practically combined with any other aspect of the treatment strip described herein.

[0088] FIG. 39 shows a further alternative where the eyelid treatment system 330 may be configured in a combined dual strip design, for example, a "wishbone" design, and the dual strip heating strips may have two heating elements along the positions of the meibomian glands of the upper eyelid UL and the lower eyelid LL of one eye. Also, depending on whether both eyes, one eye, and / or both the upper and lower eyelids are to be treated, the system 330 may consist of a first heating strip assembly 332 and a second heating strip assembly 334 for each eye. Each of the assemblies 332, 334 may correspondingly utilize upper and lower eyelid treatment heaters, for example, an upper eyelid treatment strip 332A and a lower eyelid treatment strip 332B, and each of the upper and lower elements may be coupled to each other via a wire 336 (e.g., a flexible circuit). Further, each assembly 332, 334 may be coupled to the control unit 340 via a connection cable 338. The control unit 340 may be coupled to a portable electronic device 342 (e.g., a smartphone, tablet, PDA, laptop computer, etc. having a touch screen interface) (e.g., via an input / output port such as a headphone jack, USB port, micro HDMI, or other connection port) as shown.

[0089] In other aspects, instead of using one cable 338, a range of 1 to 4 connector cables can be used for the connection cable. For example, one cable can be used to provide power and communication to several or all four heating elements of each assembly 332, 334. Alternatively, four connection cables may provide power and communication to each heating element of the assemblies 332, 334. In yet another alternative, two connection cables may provide power and communication to each of the assemblies 332, 334.

[0090] In other additional aspects, any of the described treatment strips may be used in combination with the control unit 342 described herein, for practical purposes. In a further aspect, an elliptical or circular heating element may cover the eyes and both eyelids, and the outer edges of the heating element or strip may follow the path of the upper and lower meibomian glands. In this case, a single treatment strip can cover both eyelids and both sets of meibomian glands, and the user can use a total of two (not four) circular, round, or elliptical treatment strips to cover both eyes. Such an aspect can be used, for example, for nocturnal treatment performed in bed before or during sleep when the eyes do not necessarily have to be open.

[0091] Assemblies 332, 334 are composed of strips as described above, and these strips are along the position of the meibomian glands while enabling the patient to blink easily and live comfortably in daily life. Examples of such heaters configured to be used in combination with the treatment system 330 include those commercially available from companies such as Minco Products, Inc. (located in Minneapolis, Minnesota), as well as thin and flexible heaters that can be custom-designed and manufactured or manufactured by a third party. Each of the individual treatment strips, for example, treatment strips 332A, 332B, is sized for one eyelid, for example, 28 mm × 7 mm × 0.15 mm, the length of the bottom cord is, for example, 28 mm, the radius of curvature is, for example, 75 mm, and it has a general configuration of an arcuate rectangle with an obtuse corner such that the nasal or temporal edge coincides with the radius of the arc. However, these size limitations are exemplary and not limiting. The reason is that the treatment strips 332A, 332B can be made smaller or larger to accommodate different eye anatomical tissue structures.

[0092] Furthermore, the individual treatment strips 332A, 332B may be formed as thin and flexible transparent polymers containing heating elements, and the contact surface of the strips may be attached to the corresponding eyelids with, for example, disposable adhesives. In other embodiments, opaque strips or colored strips such as skin color may also be used. Additionally, one or more temperature sensors may be provided integrally with the treatment strips, in which case the heating elements and sensors are wired via a connection cable 338 to a power supply and / or a control unit 340 and / or a portable electronic device 342 as shown in the figure.

[0093] The control unit 340 is generally composed of a hardware / software platform or unit programmed to control the treatment. Thus, the control unit 340 may include, in addition to a processor, a power source such as a battery (rechargeable or disposable) for supplying power to the assemblies 332, 334. The power source within the control unit 340 may optionally be rechargeable separately from the portable electronic device 342, or the power source may supply power directly from the portable electronic device 342 to the assemblies 332, 334 and the processor.

[0094] If the control unit 340 is programmed to provide a treatment protocol, one or more controls for controlling the treatment may be directly incorporated into the control unit 340. The portable electronic device 342 is an interface with the control unit 340 and, in one aspect, may display some of the controls, such as controls for starting and / or stopping the treatment, on the screen (e.g., touch screen) of the electronic device 342. The control unit also has functions for detecting that the leads are not correctly connected, measuring the power level, and measuring the temperature level. Thus, if any of these values are out of range, there are functions to notify or warn the user, or to prevent the start of the treatment or stop the treatment until these scenarios are explicitly recognized or corrected. Alternatively, while all of the controls are installed on the control unit 340, the display on the electronic device 342 can mainly serve to display or track various results, treatment parameters, and treatment statuses. Also, the display and the control unit can be used individually in combination.

[0095] As yet another alternative, all controls may be present on a display of an electronic device 342 for controlling various treatment options and parameters, rather than on the control unit 340. In this aspect, an electronic device 342 such as a smartphone can supply power to the treatment strip assemblies 332, 334, further control various treatment temperatures and times, and receive and display temperature feedback and other physiological parameters that are measured. In this case, the treatment strips 332, 334 and the connection cable 338 can be plugged directly into a mobile device or a personal portable electronic device 342. For example, the electronic device 342 may be used to display treatment parameters and controls such as icons and buttons for initiating treatment. In one example, a user can initiate treatment via the electronic device 342 and heat one or more of the strips of one or both of the treatment strip assemblies 332, 334. In any aspect, depending on how the electronic device 342, particularly in the case of a smartphone or a tablet terminal, is used in combination with the control unit 340 and the assemblies 332, 334, any program or application that facilitates various controls and / or display parameters on the electronic device 342 may be downloaded onto the device. Depending on the aspect, the display and control display may be provided on the control unit 340 itself or on a device separate from the control unit 340.

[0096] In addition, the electronic device 342 can also provide a diagnostic function for the user to examine dry eyes and / or to determine the progress of treatment either before, during, or after treatment. Therefore, the electronic device 342 or the control unit 340 can image the user's tear film or the surface of the eyeball to evaluate commonly used tear evaluation criteria such as the thickness of the total tear film layer, and / or the thickness of the tear film mucin layer, and / or the thickness of the tear film lipid layer, and / or the thickness of the tear film aqueous layer, or any combination thereof. For this purpose, for example, a built-in camera and / or a flash / light source can be utilized. Such a camera can display the arrangement of the strip or "mirror" it, allowing the user to evaluate or adjust it synchronously or asynchronously, either locally or remotely. The mobile application can include other common methods for diagnosing dry eyes in addition to imaging at least one of the user's tear film and ocular surface. For example, a user questionnaire regarding the user's patient symptoms, discomfort, and / or improvement or worsening of symptoms can be filled out using the touch screen interface of the electronic device, and the results can be saved in the electronic device 342 or a web application or the manufacturer's server, tracked over time for trend evaluation, and in some cases shared with the user's attending physician.

[0097] Furthermore, in any aspect, at least one of the control unit 340 and the electronic device 342 may be programmed or initiated to heat the assemblies 332, 334, for example, to 42.5°C plus or minus 1°C to 2°C. The treatment time may be set, for example, to 1 minute to 30 minutes or 60 minutes or more, and at least one of the control unit 340 and the electronic device 342 may be further programmed to shut down when the allotted treatment time has elapsed or when the measured temperature exceeds a predetermined level (e.g., 45°C). Additionally, at least one of the control unit 340 and the electronic device 342 may be programmed or set to indicate various treatment parameters (start of treatment, heating of the heating element, completion of treatment, error, battery level, etc.) by any number of visual, auditory, or tactile indicators.

[0098] In addition, using at least one of the control unit 340 and the electronic device 342, various data such as past treatment data, usage time, total treatment time, temperature data, etc. can be stored and / or transmitted. Further, at least one of the control unit 340 and the electronic device 342 may communicate wirelessly with a remote server or an additional control unit, whereby at least one of the control unit 340 and the electronic device 342 can also be remotely programmed, for example, by a doctor or the like. In yet another aspect, at least one of the audio and visual information received from the remote server (e.g., advertisements, educational media, connectivity to social media, or other media) may be displayed on at least one of the control unit 340 and the electronic device 342, or various other data may be sent to and / or from at least one of the control unit 340 and the electronic device 342.

[0099] In yet another aspect, the control unit 340 is illustrated as being coupled to assemblies 332, 334 via the wired connection cable 338, but in other aspects, the control unit 340 may be wirelessly connected to assemblies 332, 334. Such a connection can be made via any number of wireless protocols such as Bluetooth® or RF.

[0100] This “precision temperature control” portable warming treatment system can also be used for warming other parts of the body. In this case, the system is substantially the same, but the dimensions of the heating elements and the required power can be changed according to the total surface area to be treated, the temperature target, the patient's comfort, and other circumstances.

[0101] By incorporating a processor into the treatment strip, other parameters such as the treatment time and the temperature of the strip can be programmed, and the patient can selectively, optionally, or automatically switch it on / off. Further, to further enhance the flexibility of the treatment, other parameters such as the supply of heat and the frequency of other stimuli can also be programmed by the processor.

[0102] In yet another alternative, the treatment strip assembly can be used in combination with a control unit 350 that is specially designed and programmed to be used in combination with the treatment strip assembly. An example of such a control unit is shown in the perspective view of FIG. 40, which shows that the control unit 350 is a circular housing having a weight of less than (or greater than) 8 ounces (about 226.79 grams), for example, and encloses a control board incorporating a power supply and a programmable processor. The control unit housing 352 may incorporate two ports 354 for plugging in two heater assemblies, i.e., a first port for connecting a first treatment assembly for the first eye and a second port for connecting a second treatment assembly for the second eye, but in other embodiments, one port may be used to treat one eye. If only the tissue around the first eye is to be treated, one port can be used. A connector indicator 358 may be included to provide a visual indicator (and / or an audible indicator) to show the user whether at least one of the first and second ports 354 is properly connected to a heater. Also, a charging port 356 for connecting to a power supply for charging the control unit 350 may be incorporated into the housing 352. The ports 354 for the heater assemblies of the control unit are oriented such that they cannot be charged relative to the charging port 356, regardless of the number of heaters connected to the control unit.

[0103] The power button 360 may be provided so that the user can turn the control unit 350 on / off, and the power indicator 362 may be provided to indicate the power level of the control unit 350. Also, in addition to the power indicator 362, a temperature control unit 364 may be provided so that the user can adjust the temperature of the strip assembly by pressing “+” or “-” as needed during treatment. In addition, a timer 366 may be provided to provide feedback such as visually (and / or audibly) indicating the countdown of the treatment time. For example, when a 12-minute timer is started, each display bar of the timer 366 blinks for 1 minute and then turns off until the entire 12-minute treatment time has elapsed.

[0104] As shown in FIGS. 41A and 41B, the control unit 350 may provide a visual display as indicated by the connector indicator 358. When the first connector 370A for the first treatment strip assembly is inserted into the first port 354A, similarly, the display when the second connector 370B for the second treatment strip assembly is inserted into the second port 354B can be indicated by the connector indicator 358.

[0105] FIGS. 42A and 42B are various perspective views of the housing 350, and the housing 352 is shown transparently to clarify a part of the internal components included in the housing 352. For example, in order to supply power to the first and second treatment assemblies, the first and second power supplies 380A, 380B, such as rechargeable batteries, may be incorporated into the housing 352. In addition, a control board 382 equipped with a programmable processor may be incorporated into the housing 352 to control various safety elements of the treatment parameters.

[0106] For example, the control board 382 and the processor may be programmed to start a treatment session by applying power to the treatment strip assembly (when connected to the control unit 350) for a treatment time of about 12 minutes (however, this treatment time can be changed as necessary or desired). The applied voltage supplied by the power supplies 380A, 380B is activated by the control board 382 to supply current through the electrical traces of the heater strip, and heat can be applied to the eyelid at a temperature of about 42.5°C. The control board 382 may be programmed to heat the treatment strip to the treatment temperature within, for example, 20 seconds after starting the treatment (for example, in a temperature control setting such as a room temperature of 20 to 26°C).

[0107] The control board 382 may be programmed to include a temperature sensing feedback loop that can maintain a nominal temperature of 42 plus or minus 1°C, and further, to provide a visual and / or audible warning if the treatment strip drops below a threshold temperature, for example 39°C, at any point during the treatment. Also, the control board 382 may be programmed to prohibit the surface temperature of the treatment strip from exceeding the maximum temperature for a predetermined period, for example a cumulative period of 5 seconds or less, during the treatment. The control unit may be programmed to identify a temperature discrepancy of one treatment strip, which may indicate that the strip is partially adhered to the patient's face. Each strip is equipped with a plurality of sensors, which can accurately grasp the temperature difference for each part along the strip, and optionally, can more accurately and quickly detect a temperature separate from the strip and adjust accordingly.

[0108] If the user determines that the treatment strip assembly is too hot, the user may adjust the temperature control unit 364 to adjust the treatment temperature, or stop the treatment by any of the following: 1) momentarily pressing the power button 360 on the control unit 350; 2) turning off the power of the control unit 350 (e.g., pressing and holding the power button for 3 to 5 seconds); 3) removing the treatment strip assembly from the control unit 350; 4) removing the treatment strip assembly from the patient's eyelid. After the treatment is completed or stopped, the treatment strip assembly may be removed from the patient's eyelid, disconnected from the control unit 350, and discarded.

[0109] The power supplies 380A, 380B within the control board 350 are sufficient for at least five 12-minute heat treatment cycles, and the control board 382 may be programmed not to start a treatment cycle if recharging is required (e.g., when the remaining charge of the power supplies 380A, 380B is less than 25%).

[0110] In addition, the control board 382 may be programmed to automatically cut off the power to the treatment strip when one or both of the connectors 370A, 370B are removed from the corresponding ports 354A, 354B. The treatment session may be paused, and the status of the temperature indicator 364 may change to indicate that the treatment strip has been disconnected from the power supply.

[0111] In addition, the control board 382 may be further programmed to perform an automatic shut-off during periods other than the heating cycle, e.g., if it has not been active for 15 seconds (such as when no start / stop operations, heater or charger connections, etc. have been performed).

[0112] The control unit 350 can be charged either by directly connecting to a power source or via the charging port 356. Alternatively, as shown in the perspective view of FIG. 43, a separate charging station 390 may be provided that includes a receiving cradle 392 for holding the control unit 350. The charging port 356 may be aligned with a charging port integrally provided in the receiving cradle 392. In another example, the charging station 390 may be configured to charge the control unit 350 wirelessly, for example, by non-contact charging, such that the control unit 350 may simply be placed in the vicinity of the charging station 390 rather than being plugged into a charging connector.

[0113] As yet another alternative, the control unit 350 may have one or more replaceable battery packs that are charged externally to the control unit 350 and can be replaced by the user when one pack is depleted.

[0114] As yet another example, the control unit may be configured to incorporate a plurality of additional functions not only for the treatment of dry eye but also for the diagnosis of dry eye (and any other eye-related symptoms).

[0115] In the aspect shown in the perspective view of FIG. 44A, the control unit 400 may be configured to integrally form an imaging element 406, such as a camera, along the surface 404 of the control unit 400, for example, the surface opposite the control interface, as shown. Also shown is that the position of the port 402 for connecting to one or more heating strips is arranged along the edge of the control unit housing. The imaging element 406 can be placed anywhere along the surface 404 that is suitable for the imaging element 406 to visually recognize and analyze the eyeball (either one eye individually or both eyes simultaneously) and the eyelid including the surrounding Meibomian glands. The imaging element 406 according to one aspect may be arranged in the vicinity of the edge along the surface 404 of the control unit housing. As shown in the perspective view of FIG. 44B, in another example, the imaging element 408 may be arranged along the surface 404 near or at the center of the control unit 400.

[0116] In another example, as shown in the perspective views of FIGS. 45A and 45B, the image sensor 410 may incorporate a light 412 close to the image sensor 410 or a light 422 close to the image sensor 420 in order to sufficiently illuminate the eyeball and the surrounding eyelids.

[0117] In yet another example, as shown in the perspective view of FIG. 46, the control unit 400 may incorporate a screen or display 430, which may be a touch screen display, along a surface 404 close to the image sensor 406 in order to display a prompt or other information to the user.

[0118] When the control unit 400 is configured to acquire images of the patient's eyeball and the surrounding eyelids, a processor built into the control unit 400 can, for example, program a meibography function. For example, the control unit 400 can acquire images of the patient's eyelids (or inner eyelids) and meibomian glands, compare the images with any previously acquired images, track the progress of the treatment, and / or determine the health status of the meibomian glands. In addition, the control unit 400 may incorporate a memory function for storing a plurality of images and other related data regarding the eyelids and meibomian glands. The comparison and analysis of one or more selected images may be selectively achieved when initiated by at least one of the patient and the doctor, or automatically by a processor within the control unit 400. Additionally, the control unit 400 is equipped with a wireless or wired function for connecting to the Internet and can transmit at least one of data and images to one or more selected users via an interconnected server.

[0119] Furthermore, when analyzing the images, the control unit 400 may be programmed to, for example, perform simple diagnostic outputs or evaluations, and / or be programmed to show trends of physiological or disease markers as the treatment progresses.

[0120] The control unit 400 not only tracks, compares, and diagnoses the states of the eyelids and Meibomian glands, but may also program the process to provide an ocular surface diagnosis function, for example, a staining imaging function of at least one of the cornea and the conjunctiva. Other functions include tear film analysis, interferometry, lipid layer thickness analysis, analysis of the aqueous layer (height of the tear meniscus), mucin layer analysis, etc. Further features include non-invasive measurement of tear breakup time, blink analysis function, image analysis function of the size and dimensions of the eyelids, etc., which can be used to form, for example, a custom-sized therapeutic heating strip for an individual patient.

[0121] When using meibography, various methods can be utilized, such as infrared meibography, laser confocal meibography, contact meibography, non-contact meibography, optical coherence tomography meibography, etc. In addition, infrared light can also be used for meibography, for example, an infrared filter and an infrared solid-state image sensor camera can be used to image the eyelids.

[0122] Furthermore, when imaging the eyeball and / or the eyelids and / or other parameters, it may be possible to image the digitally inverted eyelids or the interior of the eyelids. For example, it is also possible to image the morphology of the Meibomian glands in vivo. That is, it is possible to image the inner surface in contact with the surface of the eyeball.

[0123] Any one or all of the described functions can be incorporated in combination with any variant of the control unit described herein. Furthermore, any of the aspects of the heating strip can be used in any number of combinations with the various embodiments of the control unit described herein.

[0124] When acquiring images of the patient's eyelids and Meibomian glands, the control unit 400 may include a function that enables the patient or the operator (such as a doctor or a nurse) to confirm that their eyelids are being properly imaged by the imaging device 406. FIG. 47 shows an example in which a display 440 for displaying an image of the patient's eyeball and eyelid 442 captured by the imaging device 406 is incorporated into the control unit 400. In this way, the user can confirm that a proper image of their eyelid is being captured by the imaging device 406 in use. Another example is shown in the perspective view of FIG. 48, where proper image detection can be performed by the control unit 400. During image capture by the imaging device 406, the control unit 400 may automatically determine by image analysis whether a proper image of the user's eyeball and eyelid is being captured or has been captured. To confirm whether a proper image has been obtained or whether a new image is needed, an indicator 450 such as a warning by light or sound may be provided to the user (patient or operator).

[0125] As yet another alternative, the control unit 400 may incorporate the imaging device 406 directly onto the surface 404. Alternatively or additionally, the control unit 400 may wirelessly communicate with a separate imaging device 460 (such as a smartphone, tablet, laptop, etc.) that incorporates a camera and has a wireless function. For example, the user may use a smartphone to acquire an image of at least one of the eyeball and eyelid and transmit the image wirelessly directly to the control unit 400 for meibography analysis. Alternatively, the imaging device 460 may be used to acquire and analyze an image and directly transmit the result to at least one of the control unit 400 and other users.

[0126] The uses of the above-described devices and methods are not limited to the treatment of dry eye syndrome and can include any number of additional treatment uses. Further, such devices and methods can also be applied to other treatment sites within the body where acute or chronic inflammation causes a disease or disorder. The treatment strip can thus be custom-designed to follow the passage of the underlying physiological tissue, for example, to treat the sinuses and acute or chronic sinusitis, rhinitis and allergic rhinitis, arthralgia and joint inflammation, arthritis, muscle pain, low back pain, headache, wound, sports injury, etc., a cooling or warming treatment strip with a formed outer shape can be custom-designed. Modifications of the above-described assemblies and methods for carrying out the present invention, combinations between different executable aspects, and variations of aspects of the present invention that are obvious to those skilled in the art are intended to be within the scope of the claims.

Claims

1. a controller configured to connect to one or more heating strips; an imaging element capable of communicating with the control unit and remotely disposed from the control unit, the imaging element being configured to image at least one of an eyeball and an eyelid of a patient; Equipped with A treatment system, wherein the control unit is configured to receive images of at least one of the eyeball and the eyelid obtained from one or more treatment sessions of the eyeball and / or the eyelid from the imaging element, and wirelessly transmit the images to a server to determine a physiological condition of at least one of the eyeball and / or the eyelid by comparing a physiological condition of the eyeball and / or the eyelid from a first treatment session with a physiological condition of the eyeball and / or the eyelid from one or more subsequent treatment sessions.

2. The system of claim 1 , further comprising a light for illuminating the eye and / or the eyelid.

3. The system of claim 1 , further comprising a display in communication with the control unit.

4. The system of claim 1 , further comprising a visual or audio indicator in communication with the control unit.

5. The system of claim 1 , wherein the control unit is configured to wirelessly communicate with the imager to receive the image of at least one of the eye and the eyelid.

6. 2. The system of claim 1, wherein the control unit is configured to track a physiological condition of the eye and / or eyelid over the one or more subsequent treatment sessions.

7. The system of claim 1 , wherein the control unit is configured to analyze the condition via infrared meibography, laser confocal meibography, contact meibography, non-contact meibography, optical coherence tomography meibography, or infrared light.

8. The system of claim 1 , wherein the control unit is further configured to receive an image of an inside of the eyeball and / or the eyelid.

9. The system of claim 1 , wherein the control unit is programmable to monitor and guide the temperature of the one or more heating strips to provide therapy.

10. The system of claim 1 , wherein the controller is programmable to maintain a set point temperature of the one or more heating strips above a threshold temperature and below a maximum temperature for a predetermined treatment period.

11. 2. The system of claim 1, wherein the one or more heating strips are configured to emit thermal energy to an area underlying the skin, and the one or more heating strips are contoured to conform to a location of one or more meibomian glands contained within the area underlying the skin.

12. 10. The system of claim 1, wherein the one or more heating strips are configured to be attached to a site beneath the skin adjacent one or both of the subject's eyes, the one or more strips enabling the subject to blink naturally with minimal or no restriction from the one or more heating strips.

Images