RU2808478C2 - Systems and methods for treating eye diseases - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: system for the treatment of eyelids, meibomian glands. A system for treating eyes of a mammal that has an eyelid includes: a portable device having: an instrument body with a fastening latch and an electrical connecting pin; a control switch that controls a power converter comprising a device emitting light energy at wavelengths including a first wavelength selected to pass through the eyelid and a second wavelength selected to be absorbed by the eyelid for heating; and an actuator controlled by a compression control button to move the movable casing away from the instrument body, the movable casing being configured to hold and supply light energy through the movable casing; an attachable component having: a fastening tongue configured to connect to a fastening latch of the instrument body; an outer eyelid pad configured to be placed in front of or on the outer surface of the eyelid, wherein the outer eyelid pad is made of a transparent material that transmits light energy delivered by the movable casing; and a backplate configured to be positioned behind or on the inner surface of the eyelid, the backplate being made of or covered with an energy reflective material configured to receive a first wavelength of light energy transmitted through the eyelid and reflect it back into the eyelid. Moreover, when the eyelid is located between the outer eyelid pad and the back plate, light energy from the energy converter heats the target tissue area of the eyelid sufficiently to melt meibomian gland secretions within the area of meibomian glands located within or adjacent to the target tissue area. Moreover, when the movable casing moves away from the instrument body, the movable casing forces the outer eyelid gasket to move towards the back plate and compress the eyelid to squeeze out the meibomian glands.

EFFECT: use of this invention will improve the treatment of meibomian gland dysfunction and blepharitis.

7 cl, 28 dwg

Description

Cross references to related applications

[0001] This application claims benefit from U.S. Provisional Patent Application No. 62/776,333, filed December 6, 2018, which is incorporated herein by reference. The priority of the above-mentioned filing date is claimed.

BACKGROUND OF THE INVENTION

[0002] The present invention relates to medical devices and methods for using them. More specifically, the present invention relates to systems, methods and apparatus used for the diagnosis and treatment of eye diseases such as meibomian gland dysfunction and blepharitis, typically affecting the eyelids, meibomian glands, ducts, orifices and surrounding tissue.

[0003] Meibomian gland dysfunction (MGD) is believed to be the most common cause of evaporative dry eye disease, with prevalence rates estimated to range from 20% to 60% of the general population. MGD is caused by the inability of the meibomian glands to produce enough normal secretions (called meibomian gland secretions). Meibomian gland secretions are a lipid-rich essential component of a healthy tear film. If the meibomian gland secretion is not present in the tear film in sufficient quantity, the film evaporates easily, leading to evaporative dry eye disease. Some patients may experience increased viscosity and melting point of meibomian gland secretions, resulting in thickening of meibomian gland secretions that do not flow freely from the glands. In addition, the channel, or duct, in the meibomian gland can become hyperkeratinized, which leads to excess production of cellular waste products and, over time, contributes to blockage of the gland. When the glands become chronically blocked (congested), they may atrophy and no longer have the ability to produce or secrete meibomian gland secretions.

[0004] Blepharitis is a common chronic inflammatory disease affecting the eyelid and eyelid margin and is often associated with MGD. Studies show the prevalence of blepharitis in the general population ranging from 12% to 47%, with a higher prevalence among older adults. In addition to some of the causative factors associated with MGD, blepharitis can be caused in part by the spread of certain bacteria in and around the eye and eyelid. The bacterial products are thought to irritate the eye, leading to additional inflammation and discomfort to the patient. Additionally, several types of mites may play a role in increasing inflammation of the meibomian glands or sebaceous glands in or around the eyes. Inflammation caused by these factors can lead to further narrowing of the meibomian gland ducts, limiting the flow of meibomian gland secretions from the glands and exacerbating the disease.

[0005] Diagnosis of meibomian gland dysfunction can be accomplished in many ways. Typical approaches include measuring tear breakup time (TBUT), staining various ocular surfaces, and examining the meibomian glands and their secretions. One common technique used to examine the glands themselves is to invert the eyelid and place a light source under the inverted eyelid (on the outer surface of the eyelid) while examining the "see-through" image of the glands created by light passing through the eyelid. This image can be observed with the naked eye, through a biomicroscope or using a camera. Healthy glands appear as elongated, relatively straight structures, whereas dysfunctional glands may appear tortuous and swollen, and atrophied glands exhibit a lack of continuity between the gland mass and the duct or ostium. In some cases, infrared light is projected onto or through the everted eyelid and an IR-sensitive camera is used to examine the meibomian glands. The disadvantage of these transillumination techniques is that they require eversion of the eyelid, which is uncomfortable for most patients and may be difficult for the clinician to perform on some eyelids.

[0006] Another well-known technique for diagnosing MGD is the application of pressure to the eyelid while observing the ducts or orifices of the meibomian glands along the edge of the eyelid, usually using magnifying means such as a biomicroscope. In response to applied pressure, healthy glands produce a clear, oily secretion. Glands that are partially dysfunctional produce less oily fluid and/or a cloudy oily fluid. Glands that are more seriously dysfunctional (congested) produce a pasty secretion that can only be squeezed out when greater pressure is applied to the eyelid. Glands that are completely atrophied or have blocked openings do not produce any oily fluid even under high pressure.

[0007] MGD and blepharitis are chronic diseases with limited effective treatments. One of the most common recommended treatments is applying a hot compress and massaging (using a compress or fingertips) to the eyelid area. The intended goal of hot compress treatment is to heat the compacted meibomian glands, which contain thickened meibomian gland secretions, causing the meibomian glands secretions to soften and thus allow easier discharge from the ducts. This method is supposed to clear the blockage of the ducts and thus allow the ducts to continue normal secretions and maintain a healthier tear film. Patients are usually instructed to apply a hot pad or other hot compress to the eyelid for five to ten minutes several times a day. However, the effectiveness of this approach may be limited.

[0008] Outpatient treatment for MGD is often limited to squeezing the affected eyelids to squeeze out meibomian gland secretions from the blocked or hardened glands. Most clinicians use a fingertip or a cotton swab to apply pressure to the outer eyelid, but sometimes they also use a swab or flat metal device (sometimes called a Mastrota paddle) on the inside of the eyelid while applying pressure to the outer eyelid to force out secretions. meibomian glands. All of these techniques are inconvenient for clinicians and painful for most patients.

[0009] Another outpatient treatment method uses intense pulses of light (IPL) near the eyes and eyelids. This treatment has been shown to improve dry eye symptoms after a few sessions, but the mechanism is not understood and the equipment is expensive.

[0010] Another outpatient treatment option is the TearScience LipiFlow(r) system, in which heating elements are placed under the eyelids and an automated external control device maintains the heating elements at a predetermined temperature while applying pressure to the outer eyelids in a predetermined pattern using inflatable bladders. This system is expensive and does not allow the clinician to control the treatment to visually monitor the eyelid margin and meibomian gland ducts, or to vary the level of heat and compression during the procedure in a manner that optimizes treatment outcome. This kind of clinical management of care can be important, but is missing from the TearScience system.

[0011] Patients can also use saline drops or artificial tears to relieve dry eye discomfort, but this approach does not cure meibomian gland dysfunction and underlying inflammation. Additionally or alternatively, antibiotics may be prescribed to reduce the bacterial load in and around the eyelid. Topical and oral antibiotics are available, including oral tetracycline derivatives, which reduce the number of some bacteria and provide a mild anti-inflammatory effect; however, administration of antibiotics may cause side effects or adverse allergic reactions, and this approach is often insufficient to provide sufficient long-term relief of blepharitis and MGD. Corticosteroids may be prescribed to reduce inflammation; however, long-term use of these steroids increases the risk of harmful changes in the lens cortex, surges in intraocular pressure, and infections due to immune suppression.

[0012] Therefore, there is a need for improved methods and devices for diagnosing and treating meibomian gland dysfunction and blepharitis.

SUMMARY OF THE INVENTION

[0013] The embodiments described herein may satisfy one or more of the needs identified above and may overcome one or more disadvantages of current treatments for MGD and blepharitis. Each of the various implementations of systems, methods and devices within the scope of the appended claims has several aspects, none of which, individually, are solely responsible for the desirable features described herein. Without limiting the scope of the appended claims, certain features are described herein.

[0014] The present invention generally relates to therapeutic systems, methods and devices useful for treating the eyelids, meibomian glands, ducts and surrounding tissue. Details of one or more embodiments of the subject matter described in this application are set forth in the accompanying drawings and description below. Other features, embodiments and advantages will become apparent from the description, drawings and claims.

[0015] In one aspect, a device is provided for treating the eye of a mammal that has an eyelid, the device comprising: an energy converter comprising a device emitting light energy at multiple wavelengths, including a first wavelength selected to pass through the eyelid and a second wavelength waves selected to be absorbed by the eyelid for heating; a front plate configured to be placed adjacent to the outer surface of the eyelid, this front plate being made of a transparent material transmitting wavelengths of light emitted by the energy converter, the front plate further comprising sensors configured to provide information about the position of the eyelid relative to the front plate; a backplate configured to be positioned proximate the inner surface of the eyelid, the backplate being made of or covered with an energy reflective material configured to receive a first wave of light energy transmitted through the eyelid and reflecting it back into the eyelid, the backplate further contains sensors configured to provide information about the position of the eyelid relative to the anterior plate; and wherein the eyelid is positioned between the anterior plate and the posterior plate and light energy from the energy converter heats the target tissue area sufficiently to melt meibomian gland secretions within the meibomian glands located in or adjacent to the target tissue area.

[0016] In embodiments, the device further comprises an actuator coupled to the front plate and the back plate, configured to effect relative movement between the front plate and the back plate to compress the eyelid to squeeze out the meibomian glands. In embodiments, the actuator is further configured to control the amount of light energy emitted from the energy converter at the second wavelength, and thereby control heating of the target tissue. In embodiments, the actuator is at least one of a lever, a button, a wheel, a slider, and a switch.

[0017] In embodiments, the energy converter is further configured to provide light energy at a third wavelength selected for bacteriological treatment. In embodiments, the power converter comprises at least one of an LED, a laser, an incandescent lamp, a xenon lamp, a halogen lamp, a fluorescent lamp, a high intensity discharge lamp, and a gas discharge lamp.

[0018] In embodiments, the device further comprises an imaging device for viewing the eyelid during treatment. In embodiments, the device further comprises one or more components selected from the group consisting of: a display or instrument panel configured to display the status of the device; a temperature measuring device configured to measure various temperatures of the eyelid, including temperatures of the inner and/or outer surfaces of the eyelid; data logger; voice recorder; a battery configured to provide power to the components of the device; battery charging means; control devices; printed circuit board; and communication circuits between the screen and the energy converter.

[0019] In another related aspect, a method of treating a disease of the eye of a mammal is provided, the method comprising: placing a screen near the inner surface of the eyelid, the screen being made of or covered with an energy-absorbing material, the screen further comprising sensors configured to provide information about the position of the eyelid relative to screen; placing an energy converter on the outside of the mammal's eyelid, the energy converter being configured to represent light energy at one or more wavelengths; placing the energy transfer surface on the outside of the eyelid, this energy transmission surface includes sensors configured to provide information about the position of the eyelid relative to the energy transfer surface; effecting a relative movement between the power transfer surface and the screen to change the spatial relationship between the power transfer surface and the screen; directing light energy from the energy converter to the screen at a first wavelength selected to heat the energy-absorbing material; and heating the energy-absorbing material with light energy to heat the target tissue area sufficiently to melt meibomian gland secretions within the meibomian glands located in or adjacent to the target tissue area.

[0020] In embodiments, the method further includes directing light energy from the energy converter to the outer surface of the eyelid at a second wavelength selected to heat a target tissue area within the eyelid. In embodiments, the method further includes directing light energy from the energy converter to the eye at a third wavelength selected for bacteriological treatment.

[0021] In embodiments, the method further includes compressing the eyelid between the energy transfer surface and the screen. In embodiments, the method further includes focusing the compression on the stye or pimple for the purpose of treating hordeolum. In embodiments, the method further includes focusing compression on the blocked gland to treat the chalazion.

[0022] In embodiments, a fuse electrically coupled to the power converter prevents or interrupts the occurrence of light energy if the shield and associated assembly are not attached to and aligned with the device incorrectly.

[0023] In embodiments, the relative movement between the power transfer surface and the screen includes movement of the power transfer surface relative to the screen. In embodiments, the relative movement between the power transfer surface and the screen includes sliding movement of the power transfer surface relative to the screen. In embodiments, effecting relative movement between the power transfer surface and the screen includes operating an actuator coupled to the power transfer surface. In embodiments, actuating the actuator involves pressing a button. In embodiments, effecting relative movement between the power transfer surface and the screen includes causing the power transfer surface to slide relative to the screen.

[0024] In embodiments, for the energy converter to emit light energy, the position of the eyelid relative to the positions of the screen and the energy transmission surface must be within a predetermined range.

BRIEF DESCRIPTION OF GRAPHIC MATERIALS

[0025] The above aspects, as well as other features, aspects and advantages of the present invention will be described below in connection with various embodiments with reference to the accompanying drawings. However, the illustrated embodiments are examples only and are not intended to be limiting. Throughout graphical materials, similar symbols generally indicate similar components unless the context requires otherwise. It should be noted that the relative sizes of the following figures are not necessarily drawn to scale.

[0026] In FIG. 1A is a cross-sectional diagram of a mammalian eye system 10.

[0027] In FIG. 1B is a view of the surfaces on the back of the upper and lower eyelids, showing the meibomian glands with healthy, clogged, and atrophied glands.

[0028] In FIG. 2A is a block diagram of one embodiment of an eye treatment device according to some embodiments.

[0029] In FIG. 2B is a block diagram of another embodiment of an eye treatment device.

[0030] In FIG. 2C is a block diagram of another embodiment of an eye treatment device comprising a scleral shield.

[0031] In FIG. 2D is a block diagram of another embodiment of an ophthalmic device comprising a scleral screen with imaging elements.

[0032] In FIG. 2E is an enlarged cross-sectional view of a portion of the embodiment shown in FIG. 2D.

[0033] In FIG. 2F is a front view of the embodiment shown in FIG. 2E.

[0034] In FIG. 2G is a block diagram of another embodiment of an ophthalmic device similar to the device in FIG. 2D.

[0035] In FIG. 2H is a block diagram of another embodiment of an ophthalmic device similar to the device in FIG. 2C.

[0036] In FIG. 3A is a block diagram of an embodiment of an apparatus for diagnosing and treating an eye.

[0037] In FIG. 3B is an enlarged view of one embodiment of the scleral shield shown in FIG. 3A.

[0038] In FIG. 4A is a schematic side plan view of one embodiment of an eye treatment device.

[0039] In FIG. 4B is a schematic front plan view of the power converter and waveguide modules contained in the embodiment of the eye treatment device shown in FIG. 4A.

[0040] In FIG. 4C is a schematic side plan view of an embodiment of the eye treatment device shown in FIG. 4A, which is shown in application.

[0041] In FIG. 4D is a schematic side plan view of another embodiment of an eye treatment device.

[0042] In FIG. 4E is a perspective view of optical elements in another embodiment of an eye treatment device.

[0043] In FIG. 4F-H are front, side and cross-sectional views of the prismatic element shown in FIG. 4E. In fig. 4I-L are front, cross-sectional, side, and perspective views of the forming lens element of FIG. 4E.

[0044] In FIG. 4M and 4N are theoretical graphical representations of the irradiance patterns generated by the optical elements shown in FIG. 4E.

[0045] In FIG. 5A is a schematic side plan view of a further embodiment of an eye treatment device.

[0046] In FIG. 5B is a schematic front plan view of an embodiment of the eye treatment device shown in FIG. 5A.

[0047] In FIG. 5C-F show side, top, front and perspective views of parts of another embodiment of the device.

[0048] In FIG. 5G and 5H are theoretical graphical representations of the irradiance patterns generated by the optical elements shown in FIG. 5C-F.

[0049] In FIG. 6 is a schematic side plan view of an embodiment of an eye treatment system comprising an eye treatment device and a scleral shield.

[0050] In FIG. 7A-7H are schematic front plan and side views of various scleral shield embodiments.

[0051] In FIG. 8 is a schematic side plan view of another embodiment of an eye treatment device.

[0052] In FIG. 9 is a schematic side plan view of another embodiment of an eye treatment device comprising one or more cooling mechanisms.

[0053] In FIG. 10 is a schematic side plan view of another embodiment of an eye treatment device including one or more safety sensors.

[0054] In FIG. 11A is a schematic side plan view of another embodiment of an eye treatment device.

[0055] In FIG. 11B is a schematic side plan view of another embodiment of an eye treatment device.

[0056] In FIG. 12 is a schematic side plan view of another embodiment of an eye treatment device comprising vibration means.

[0057] In FIG. 13 is a diagram of one embodiment of a system for treating an eye for human use.

[0058] In FIG. 14A is a schematic side plan view of an embodiment of an eye treatment system.

[0059] In FIG. 14B is a schematic front plan view of a portion of the embodiment of the eye treatment system shown in FIG. 14A.

[0060] In FIG. 15A is a schematic side view of an embodiment of an eye treatment monitoring system.

[0061] In FIG. 15B is a front cross-sectional view along line AA of the embodiment shown in FIG. 15A.

[0062] In FIG. 15C is a front view of the embodiment shown in FIG. 15A.

[0063] In FIG. 15D is a cross-sectional side view along line B-B of the embodiment shown in FIG. 15A.

[0064] In FIG. 16A-O show representative configurations of the energy transfer surfaces, scleral shields, and brackets of the system that define an opening allowing one or both eyelid margins to be viewed while heat and compression are applied to the portion of the eyelid being treated.

[0065] In FIG. 17A-C show an embodiment of a power converter module in combination with a power waveguide module and a power transfer surface.

[0066] In FIG. 17D is a graphical representation of the distribution of infrared light irradiance across the eyelid for the embodiment shown in FIG. 17A-C.

[0067] In FIG. 17E-F illustrate an element of a power transmission surface containing a particular coating.

[0068] In FIG. 17G is a graphical representation of the distribution of infrared light irradiance across the eyelid for an embodiment comprising a specific coating on a portion of the energy transfer surface.

[0069] In FIG. 17H shows the distribution of irradiance with greenish-yellow light on the outer surface of the eyelid for an embodiment containing a certain coating on a portion of the energy transfer surface.

[0070] In FIG. 18A and 18B are front and side views of another embodiment of an eye treatment device.

[0071] In FIG. 19 is a view showing one embodiment of a front plate of a disposable part.

[0072] In FIG. 20 shows one embodiment of an eye treatment device display showing melting timing details.

[0073] In FIG. 21A and 21B are views showing one embodiment of an eye treatment device including a movable optical waveguide.

[0074] In FIG. 22 shows additional elements of the disposable portion containing the front plate structural elements.

[0075] In FIG. 23 is an exploded view of the disposable part shown in FIG. 22.

[0076] In FIG. 24 shows additional elements of the disposable part containing thermal insulation for the backplate sensors.

[0077] In FIG. Figure 25 shows a graph of the pulsation, or alternation, of the light source and the camera.

[0078] In FIG. 26A and 26B illustrate camera embodiments used to inspect and/or photograph the eyelid surface and eyelid margin for the purpose of detecting obstructed meibomian glands.

[0079] In FIG. 27 shows another embodiment of a backplate including a heating portion for heating the eyelid.

[0080] In FIG. 28A and 28B show front and side views of another embodiment of an eye treatment device in which the disposable portion is rotatable between positions for treating the upper and lower eyelids.

DETAILED DESCRIPTION

[0081] In the following detailed description, reference is made to the accompanying drawings forming a part of the present invention. In graphical materials, similar symbols generally indicate similar components unless the context requires otherwise. The exemplary embodiments described in the detailed description, drawings and claims are not intended to be limiting. Other embodiments may be used or other changes may be made therein without departing from the spirit or scope of the subject matter presented herein. It will be readily understood that the aspects of the present invention generally described herein and depicted in the figures may be arranged, substituted, combined or designed in a wide variety of different configurations, all of which are expressly intended to form part of the present invention.

[0082] The terminology used herein is intended only to describe specific embodiments and is not intended to limit the present invention. Those skilled in the art will appreciate that if a specific amount of a claimed element is intended, that intent will be expressly mentioned in the claims, and in the absence of such mention, there is no such intent. For example, throughout this document, singular forms are intended to include the plural unless the context clearly requires otherwise. As used herein, the expression “and/or” includes any and all combinations of one or more related listed items. It will also be understood that the terms “comprises”, “comprising”, “has”, “having”, “includes” and “comprising” when used herein indicate the presence of the claimed features, objects, steps, operations, elements and/or components , but do not exclude the presence or addition of one or more other features, objects, stages, operations, elements, components and/or their groups. Expressions such as “at least one of” preceding a list of elements modify the entire list of elements and do not change individual elements of that list.

[0083] To assist in the description of the devices and methods described herein, certain relationship and directional terms are used. The terms "connected" and "bonded", as well as variations thereof, as used herein, include direct connections, such as integrally formed, bonded or otherwise attached directly to, on or in another element, etc., as well as indirect connections in which one or more elements are located between the connected elements. The terms "connected" and "coupled" can refer to a permanent or non-permanent (i.e., detachable) connection.

[0084] The term “attached” and variations thereof as used herein include methods by which an element is directly attached to another element, such as by being glued, screwed or otherwise attached directly to, on or in another element, etc. etc., as well as indirect means of attaching two elements to each other, where one or more elements are located between the fastened elements.

[0085] The terms “near” and “far” are relative terms used herein to describe a situation from the point of view of a healthcare professional treating a patient. For example, compared to the term "distant", "near" refers to a position closer to the healthcare provider, while the far end is located closer to the patient during treatment. For example, the distal ends of the devices described herein are opposed to the proximal ends of the same devices, and the distal end of the device often includes, for example, an end adapted to be positioned against a patient's eyelid.

[0086] "Transducer" is a term used herein to describe an element that takes one form of energy and converts it into another form. For example, a light source can receive electrical energy and produce light energy. Similarly, an ultrasonic transducer can receive electrical energy and produce ultrasonic energy.

[0087] The term “light” as used herein refers not only to energy in the visible region of the spectrum, but also to energy in the infrared and ultraviolet portions of the electromagnetic energy spectrum.

[0088] The term "waveguide" as used herein refers to any means that influences the propagation, distribution, or trajectory of electromagnetic energy, such as light, ultrasonic energy, and radio frequency energy. For the purposes of this document, this broad definition of waveguide includes optical elements such as diffractors, refractors, scatterers, and the like.

[0089] The term "optical path length" is used herein to describe the length of the path (eg, in a tissue section) along which energy travels.

[0090] The embodiments described herein relate to ophthalmic devices, systems and methods. The devices, systems and methods described herein can be used to treat meibomian glands, ducts, ostia and surrounding tissue, and in particular they are directed to the treatment of MGD, blepharitis and diseases having a physiological relationship with MGD and blepharitis, such as evaporative dry eye disease. In fig. 1A is a cross-sectional diagram of a mammalian eye system 10 that includes the eyeball 20 and surrounding eyelid anatomy. As referred to herein and as defined in FIG. 1A, the “central ocular axis” 30 is a central axis passing through the center of the cornea 22, iris 24, pupil 25, lens 26, and vitreous 28 of the eyeball 20. The eye system 10 includes an upper eyelid 12, a lower eyelid 14, and eyelashes 16. In the tissue of each eyelid 12, 14 there are meibomian glands 18, each of which contains an orifice, or duct, 19. In the systems 10 of a healthy eye, the meibomian glands 18 secrete from the ducts 19 a substance called meibomian gland secretion, which contains mainly lipids and proteins . The secretion of the meibomian glands forms part of the tear film covering the surface of the eyeball 20.

[0091] In FIG. Figure 1B is a view of the inside of the eyelid showing the meibomian glands with healthy, clogged, and atrophied glands. Chronic blocked glands are associated with MGD and some forms of blepharitis and can lead to blocked ducts and/or gland atrophy. Inflammation associated with MGD or blepharitis may, in turn, cause additional narrowing of the ducts of the 19 glands, leading to a reduction in meibomian gland secretion and, accordingly, a decrease in the amount of lipids in the tear film. Tear film with low lipid content can evaporate quickly and lead to evaporative dry eye. A reduced tear film may also be associated with increased levels of bacteria in and around the eye. Such bacteria can aggravate inflammation on their own or through certain waste products that irritate the eyes. It is believed that the glands can be protected from permanent atrophy by periodically cleaning chronically clogged glands.

[0092] Another factor that is believed to contribute to blepharitis is the presence of Demodex folliculorum and Demodex brevis mites, which are commonly found on most people and are reported in large numbers in individuals suffering from blepharitis. These mites can live in the hair follicles of eyelashes and eyebrows, as well as in the meibomian glands and sebaceous glands. Their very presence may lead to inflammation in some individuals, but it is also believed that these mites may carry some bacteria that may be released into the eyelid area during their life cycle, leading to additional inflammation.

[0093] In FIG. 2A is a block diagram of an eye treatment device 100 according to various embodiments. As shown in FIG. 2A, the illustrated eye treatment device 100 includes a power supply module 110, a power converter module 120, an energy waveguide module 130, and a power transfer surface 140 (also called a pressure member). In some embodiments, energy waveguide module 130 may be optional. In other embodiments, the energy converter module 120 and the energy waveguide module 130 may be combined in a single unit.

[0094] Power supply module 110 according to various embodiments provides power to power converter module 120. The power supply module 110 may include any structure configured to supply power to one or more other components of the eye treatment device 100. In some embodiments, the power supply module 110 includes a disposable battery, a rechargeable battery, a solar cell, a power conversion module such as a power supply or power converter, or a power transmission mechanism such as a cord, lead, or connector configured to receive alternating current or DC from an external source.

[0095] Energy converter module 120 may include one or more energy converters configured to emit one or more forms or types of energy. For example, as described in more detail below, in some embodiments, energy transducers emit photonic, acoustic, radio frequency, electrical, magnetic, electromagnetic, vibrational, infrared, or ultrasonic energy. In some embodiments, power converter module 120 generates multiple types of power simultaneously or in a predetermined order.

[0096] Energy waveguide module 130 includes one or more structures configured to control or focus the direction of energy emission from energy converters. For example, energy waveguide module 130 may include one or more reflectors, refractors, diffractors, or diffusers (described in more detail below) adapted to focus photon energy into a desired area, or other structures for configuring and directing energy emission, such as ultrasonic horns or fiber optics. optics.

[0097] The eye treatment device 100 shown in FIG. 2A may also advantageously include a power transfer surface 140 adapted to further direct the power generated by the power converter module 120 to a desired area. For example, the power transfer surface 140 may include one or more lenses adapted to focus the energy generated by the power converter module 120.

[0098] In some embodiments, the energy waveguide module 130 and the energy transfer surface 140 can also prevent or limit the transfer of energy generated by the energy converter module 120 to specific areas of the eye. The power transmission surface 140 may include regions that are substantially energy opaque or do not transmit energy generated by the power converter module 120 and regions that are energy transparent or transmit the energy generated by the power converter module 120 . The modules of the eye treatment device 100 are described in more detail below with respect to other embodiments of the present invention and may contain other components.

[0099] In FIG. 2B is a block diagram of an eye treatment device 100 according to various embodiments. Fig. 2B is similar to FIG. 2A and includes a power supply module 110, a power converter module 120, an optional power waveguide module 130, and a power transfer surface 140. The energy transfer surface 140 may be substantially continuous or may contain elements separated from other portions of the energy transfer surface 140 or the eye treatment device 100. For example, the power transfer surface 140 may include an additional element located at some distance from the solid portion of the power transfer surface 140. For example, in FIG. 2B, the accessory element 143 is depicted as a mesh-like structure spaced from the main portion of the power transfer surface 140 (if present). The additional element 143 may include a surface that is at least partially transparent to the desired energy generated by the energy converter module 120, while maintaining a gap between the main portion of the energy transfer surface 140 (if present), or the energy waveguide (if present), or energy converter module and surface of the 12th, 14th centuries. The clearance created by the extension 143 may be useful, for example, to provide a path for forced air cooling of the eyelid. Additionally, pressing the extension member 143 against the eyelid surface may reduce the optical path length for heating the eyelid 12, 14 and/or target components within the eyelid. Reducing the optical path length may be advantageous for tissue heating due to increased radiation yield, reduced scattering, refractive index matching, and increased integrated fluence. The extension member 143 may be made of a low specific heat material, such as fine wire or plastic mesh or a perforated thin metal or plastic surface, and may be structured to conform to the shape of the eyelid when pressure is applied to the surface of the eyelid. In one embodiment, the attachment 143 may be structured such that when pressed against both the upper and lower eyelids, it can distribute the applied pressure either uniformly or unevenly across the aligned surfaces of the upper and lower eyelids. For example, in one embodiment, the accessory element 143 may apply less pressure to the central ocular axis 30 and more pressure elsewhere, which may be desirable in cases where pressure repeatedly applied to the eyelids above the central ocular axis may be expected to increase the likelihood of developing a complication known as conical cornea. In another embodiment, the additional element 143 may be actively heated or cooled.

[00100] In FIG. 2C is a block diagram of another embodiment of an eye treatment device 100 comprising a power supply module 110, a power converter module 120, an optional power waveguide module 130, a power transfer surface 140, and a scleral shield 300 (also referred to as a backplate). In this embodiment, one or more eyelids 12, 14 are positioned between the energy transfer surface 140 and the scleral shield 300.

[00101] Energy converter module 120 may include one or more energy converters configured to emit one or more forms or types of energy. For example, as described in more detail below, in some embodiments, energy transducers emit photonic, acoustic, radio frequency, electrical, magnetic, electromagnetic, vibrational, infrared, or ultrasonic energy. In some embodiments, power converter module 120 generates multiple types of power simultaneously or in a predetermined order. An optional energy waveguide module may be included to control or focus the direction of energy emission from the energy converters, as described above.

[00102] The eye treatment device 100 shown in FIG. 2C may also advantageously include a power transfer surface 140 adapted to further direct the power generated by the power converter module 120 to a desired area. The power transfer surface 140 may include one or more lenses adapted to focus the energy generated by the power converter module 120. The energy transfer surface 140 (and/or the additional element 143 shown in Fig. 2B) may be configured to move along the movement path 145 to adjust (eg, focus) certain energy transfer properties, and/or come into contact with the surface of the eyelid 12, 14, and/or applying pressure to the eyelid 12, 14. By applying pressure to the eyelid 12, 14 while maintaining the scleral shield 300 in a fixed spatial relationship with other parts of the eye treatment device 100, the eyelid 12, 14 can be compressed, thereby , reducing the optical path length for heating the eyelid 12, 14 and/or target components within the eyelid. Reducing the optical path length is advantageous for tissue heating due to increased radiation yield, reduced scattering, refractive index matching, and increased integrated fluence. The eyelid may be compressed by the back plate 300 pressing or pressing the eyelid against the pressure member. Alternatively, the eyelid may be compressed by pressing or pressing the eyelid with the pressure member against the back plate 300.

[00103] In some embodiments, energy converter module 120 can simultaneously generate multiple types of energy, such as photonic, acoustic, radio frequency, electrical, magnetic, electromagnetic, vibrational, infrared, or ultrasonic energy. For example, the first energy may heat the outer surface of the eyelid, while the second energy may penetrate deeper into the eyelid tissue and/or interact with the scleral shield in ways that are described in more detail below.

[00104] In FIG. 2D is a block diagram of another embodiment of an eye treatment device 100 comprising a power supply module 110, a power converter module 120, an optional energy waveguide module 130, a power transfer surface 140, and a scleral shield 300 similar to that shown in FIG. 2C. In some embodiments, the scleral screen 300 may further include an image converter 155 built into the scleral screen 300. In FIG. 2E is an enlarged cross-sectional view of an image transducer 155 integrated into the scleral screen 300, with the eyelid 14 positioned adjacent to the image transducer 155. In the illustrated embodiment, the image converter 155 is reflective. Illumination energy 170, which may be visible or infrared light, for example, passes through the eyelid 14 and thus through the meibomian glands 18, and then along the optical path 175 through the energy transfer material 185 as it is reflected from the reflective surfaces 180. eventually emerging from the image converter 155 over the edge of the 14a century. It will be understood that the resulting image output from image converter 155 will be a shadow image, or see-through image, of that portion of eyelid 14 that is adjacent to image converter 155 and illuminated by illumination energy 170. Thus, the image converter 155 allows the translucent image 190 of the inside of the eyelid 14 to be viewed by direct imaging or by a magnifying element or camera, collectively shown as an imaging device or imaging tool 160, without having to evert the eyelid. In fig. 2F is a front view of the same embodiment as in FIG. 2E, which shows transillumination images of 190 meibomian glands.

[00105] The image converter 155 may include a set of mirror surfaces or a prism having reflective surfaces. Alternatively, the image converter may include a beam deflecting element such as an optical waveguide, an optical fiber bundle, an image sensor, or some combination thereof. It will be appreciated that various desired optical properties, such as projection, angular shift, or image magnification, may be included in the image converter 155. These properties can be achieved, for example, by curving the reflective surfaces 180, by shaping the surfaces from the transmission material 185 and/or by changing the refractive index, by changing the density and distribution of the fiber elements in the tow, or by some combination thereof. In those embodiments where image converter 155 includes an image sensor, the sensor may be a CCD type, a CMOS type, a fluorescent concentrator type (such as those manufactured by Johannes Kepler University, Linz, Austria), or any type of sensor capable of capturing transillumination data and their translation into visual, optical or electrical information.

[00106] In some embodiments, visualization of the 14a eyelid margin during diagnosis and treatment of the 14th eyelid provides significant benefit. For example, as described above, the positioning of the eyelid 14 between the energy transfer surface 140 and the scleral shield 300 containing the image transducer 155 allows for the imaging of a translucent image of the eyelid and meibomian glands. As shown in FIG. 1B, the morphology of healthy, obstructed, and atrophied glands is sufficiently distinct to allow diagnosis of the condition of each gland by viewing a transillumination image of the glands. Returning to FIG. 2D, the condition of the glands can also be assessed without transillumination by observing the edge of the 14a eyelid, while moving the energy transfer surface 140 along the movement path 145 to press against the eyelid 14. As the eyelid 14 contracts, the edge of the 14a eyelid is observed and the condition of the gland is assessed by the quality and quantity of the secretions of the ducts 19, as discussed earlier.

[00107] If treatment is necessary after diagnosis, the eye treatment device 100 can be repositioned along the eyelid 14 so that the majority of the affected glands are located between the energy transfer surface 140 and the scleral shield 300. Once positioned, the energy transfer surface 140 can be moved along the path 145 movement, bringing into contact with the surface of the eyelid 12, 14 and/or continuing movement to the scleral screen 300 and applying pressure to the eyelid 12, 14.

[00108] Returning to FIG. 2D, an optional coupling medium 195 may be disposed between the eyelid 12, 14 and the energy transfer surface 140. The coupling medium 195 may be a fluid, gel, cream, or the like, and may contain an agent such as glycerin, which may enhance efficacy. transmitting light into the eyelid and target tissue by reducing light scattering and improving light transmission by reducing refractive index mismatch between the eyelid 12, 14 and the energy transfer surface 140. It may also help reduce scattering by hydrated parts of the eyelid skin surface, such as the stratum corneum.

[00109] In FIG. 2G is a block diagram of another embodiment of an eye treatment device 100 comprising a power supply module 110, a power converter module 120, an optional power waveguide module 130, a power transfer surface 140, and an image converter 155 integrated into the scleral shield 300. The image converter 155 allows for redirection at least a portion of the energy from the energy transfer surface 140 to the inside of the eyelid 14. For example, the eyelid 14 may be located between the energy transfer surface 140 and the scleral screen 300 containing the image transducer 155. The energy transfer surface 140 directs energy to at least one of the outer side of the eyelid and the image converter 155. The image transducer 155 has the ability to redirect energy from the energy transfer surface 140 to the inside of the eyelid. An advantage of directing energy through the image transducer 155 to the inner surface of the eyelid is that it can provide an efficient method of delivering energy, and therefore heat, to at least a portion of the inner surface adjacent to the edge of the eyelid. By combining this heating method (via the image converter 155) with a heating method in which energy is directed through the eyelid, it is possible to optimize the overall heating efficiency of the inner surface of the eyelid and achieve preferential additional heating of the inner surface adjacent to the edge of the eyelid, since this is the area in which which may cause significant blockage and obstruction. An additional temperature sensor may be located near the tissue of the inner surface of the eyelid adjacent to the edge of the eyelid, where preferential additional heating may occur (described and depicted below with reference to Fig. 3A).

[00110] In FIG. 2H is a block diagram of another embodiment of an eye treatment device 100 comprising a power supply module 110, a power converter module 120, an optional power waveguide module 130, a power transfer surface 140, and a scleral shield 300 similar to that shown in FIG. 2C. In some embodiments, the scleral shield 300 may further include an energy converting coating 194 configured to be activated by certain types of energy passing through the eyelid. In one embodiment, the energy conversion coating 194 is configured to convert energy back toward the inside of the eyelid using the same form of energy that originally passed through the eyelid. In another embodiment, the energy conversion coating 194 can change the type of energy and direct or emit the changed energy in a preferred direction. In one embodiment, this coating is phosphorescent. For example, the energy transmitted through the eyelid may be visible or infrared light of a wavelength that easily passes through the tissue with little absorption, and when this energy reaches the energy conversion coating 194, the phosphorescent material emits light energy of a different wavelength that is more easily absorbed by the tissue adjacent to the coating, which in a preferred embodiment is the inner surface of the eyelid containing the meibomian glands. In another embodiment, a certain form of energy absorbed by the coating triggers an exothermic chemical reaction that can heat the inner surface of the eyelid. Some embodiments shown in FIGS. 2A-2H may also include one or more of the following: a scleral screen with brackets, a reflective imager built into the scleral screen, a multi-temperature display, a consumable part, a connector, and circuitry for communicating between the device and the consumable part for the purpose of identifying the consumable part. and preventing its reuse, a data logger, a voice recorder and a camera with recording and/or transmission capabilities that is powered by certain types of energy passing through the eyelid. In one embodiment, the energy conversion coating 194 is configured to convert energy back toward the inside of the eyelid using the same form of energy that originally passed through the eyelid. In another embodiment, the energy conversion coating 194 can change the type of energy and direct or emit the changed energy in a preferred direction. In one embodiment, this coating is a phosphorescent material that is activated by energy transmitted through the eyelid from the energy transfer surface 140. For example, the energy transmitted through the eyelid may be visible or infrared light of a wavelength that easily passes through the tissue with little absorption, and when this energy reaches the energy conversion coating 194, the phosphorescent material emits light energy of a different wavelength that is more easily absorbed by the tissue adjacent to the coating, which in a preferred embodiment is the inner surface of the eyelid containing the meibomian glands. In another embodiment, a certain form of energy absorbed by the coating triggers an exothermic chemical reaction that can heat the inner surface of the eyelid.

[00111] In FIG. 3A is a schematic side plan view of one embodiment of an eye treatment device 200. The eye treatment device 200 shown in FIG. 3A is indicated for placement relative to the eyeball 20 for the purpose of treating eyelid 14 for MGD, blepharitis and other diseases. In some embodiments, the eye treatment device 200 is configured to heat the inner and/or outer surfaces of the eyelid while simultaneously compressing the eyelid. As heat is transferred from the eye treatment device 200 to the eye system 10, particularly to the tissue being treated, such as the meibomian glands, the heat may soften the meibomian gland secretions and thus allow the meibomian gland secretions to be more easily squeezed out during massage or eye exercises. The eye treatment device 200 may include the module configurations shown in FIG. 2A-2H, along with additional components used in the operation of the eye treatment device 200.

[00112] The eye treatment device 200 may include a housing 202 coupled to a removable, or consumable, portion 260 that may be coupled to the housing 202 by means of attachment 186, which may be pins, guides, latches, or the like. Housing 202 may include a power supply module 110, an optional control device 212, a power converter module 120, and a power transfer surface 140 movable relative to a movement path 145 relative to the power converter module 120. Alternatively, the energy transfer surface 140 may be coupled to or constitute a part of the energy converter module 120 and optionally the thermostatic structure 220, and together may be relatively movable with respect to the housing 202 or other parts of the eye treatment device 200. Movement of the power transfer surface 140 and associated parts may be accomplished, for example, using an actuator 182. The power converter module 120 according to some embodiments, such as those shown in FIG. 3A may include an LED device formed from one or more of an LED emitter 207, an LED lens 208, a temperature control structure 220, and a power converter module driver 209. Housing 202 may further include visualization means 160 for improved monitoring of the eyelid margin during diagnosis and treatment, a display or instrument panel 218 showing various eyelid temperatures, such as inner and/or outer surface temperatures, a data logger 214, a voice recorder 213, and a circuit diagram. 226a to communicate between the device and the consumable circuit 226b to identify the type of consumable, ensure that the consumable is in proper alignment, and/or prevent reuse of the consumable. The consumable portion 260 may include a scleral shield 300 that may be positioned between the eyelid 12, 14 and the eyeball 20 to protect the sensitive structures of the eye system 10 (as shown in FIG. 1). For example, the scleral shield may be located over the sclera 21 and cornea 22, and may also provide protection to other internal structures of the eye, such as the iris 24, pupil 25, lens 26, and other light-sensitive structures of the eye system 10. Use of the scleral shield 300 may improve safety and reduce the likelihood of harmful light emissions from the energy converter module 120 reaching and damaging sensitive structures of the eye. The scleral shield 300 may be formed from an energy-absorbing material and/or may include an energy-absorbing facial surface 302. In either case, energy transmitted through the eyelid that is absorbed by the scleral shield 300 or the energy-absorbing facial surface 302 may heat the shield or facial surface, respectively, and thus ensuring heating of the inner surface of the eyelid. The back surface and edges of the scleral shield 300 are preferably made from a material and process that provides a smooth, burr-free finish that does not cause damage to, or reduce the likelihood of damage to, the cornea or other sensitive structures of the eye. In one preferred embodiment, the back surface and edges are covered with Teflon(r) foam (ePTFE). The scleral screen 300 may also include one or more temperature sensors 310 for monitoring temperature, as well as force or pressure sensors 221 for monitoring the amount of force or pressure applied to the eyelid. Sensors 310 and 221 may be coupled to circuitry in housing 202 by electrical conductors, such as wires 420. In FIG. 3B shows one embodiment of a scleral screen 300 further comprising an image transducer 155 that, as previously described, allows viewing of the inside of the eyelid 14 and the meibomian glands behind the eyelid. In some embodiments, the scleral screen 300 may further include communication means and/or an integrated power supply, both of which are discussed in more detail below as communication means 320 and an integrated power supply 330, such as in FIG. 7A. By way of further clarification, scleral shield 300 may be connected to housing 202 in various ways, such as by one or more wires 420, which wires comprise insulation with sufficient mechanical strength to serve as brackets 262. Additionally, some embodiments may include circuitry 226a and 226b for communication between the device and the consumable part.

[00113] In some embodiments, a lens 208, such as an LED lens, may be used in front of the LED emitter 207. In some embodiments, the LED lens 208 may be a specially shaped lens used to control the direction and intensity of the LED emitter 207 toward the tissue requiring treatment and/or the scleral shield 300. In some embodiments, the energy transfer surface 140 may act as a lens or be used in combination with a lens to focus and direct energy from the energy converter module 120 or LED emitter 207 to the areas requiring treatment.

[00114] Each of these components, either individually or in combination with other components of any of the embodiments described herein.

[00115] The eye treatment device 200 may include a power supply module 110 for providing power to various components of the eye treatment device 200 and may be electrically coupled to some or all of the components. In some embodiments, the power supply module 110 is a battery, operating either as conventional batteries or as rechargeable batteries that can be coupled to a charging system. In other embodiments, the power supply module 110 may be connected to an external power source, such as an electrical outlet or power from an external battery. In some embodiments, power supply module 110 may be electrically coupled to control device 212 to receive commands from control device 212 to provide electrical power to various components of eye treatment device 200.

[00116] In some embodiments containing a control device 212, the control device 212 may receive input commands from a user (e.g., through a user interface device 270 such as a button, switch, touch screen, voice commands, from another module or device, such like a smartphone) to emit light from the LED emitter 207. Upon receiving input commands from a user, the control device 212 may instruct the power supply module 110 to deliver power to or from the power converter module driver 209, which allows the LED emitter 207 to convert electrical power from the module 110 power source into another form of electromagnetic energy (such as light). Thus, the power converter module driver 209 and the LED emitter 207 can act as a converter of power received from the power supply module 110.

[00117] The power converter module driver 209 may include any LED power and control circuitry implemented as an actual printed circuit board, integrated circuit, or discrete components. In some embodiments, it functions as an LED driver that supplies a controlled current, voltage, or power level through the LED emitter 207 within the LED's specifications to produce the required lighting intensity from it. Optionally, the LED printed circuit board may include a pulse width modulation function, PID circuit, or similar circuitry for modulating the effective irradiation intensity as a function of time to achieve the desired heating of the target area of the eyelid.

[00118] The LED emitter 207 forms part of one type of power converter module 120 that may be configured to emit light of the appropriate wavelength needed for the desired treatment. Treatment may include one or more of the following: diagnosing the eyelids 12, 14 by illuminating the inner and/or outer surfaces, eyelid margins, and/or meibomian glands behind the eyelids; heating the target tissue area of the eye system 10 (for example, the meibomian glands behind the eyelids 12, 14); and antibacterial treatment to kill bacteria in the eye system 10. It should be noted that the descriptions of various devices herein (including the eye treatment device 200) are exemplary and non-limiting. Thus, for example, although this detailed description makes reference to specific elements and circuits that perform specific functions, it does not limit the present description to these particular embodiments. For example, although LEDs are mentioned, other light sources may be used, such as incandescent, xenon, halogen, high intensity discharge, cold cathode, fluorescent, laser, and other light or energy sources. Likewise, while the control device 212 and the power converter module driver 209 are mentioned, it will be understood that the control device may be incorporated into the driver circuit for the radiation source or the circuit for the solid state or other power source, or other configurations may be used to obtain the desired result. In addition, some or all of the functions described as being processed or controlled by control device 212 may be implemented using discrete logic, analog circuitry, or a combination thereof. In addition, although various embodiments, such as the eye treatment device 200, are depicted schematically, they may be configured in a variety of portable or stationary configurations with optional gripping surfaces, manipulation and control structures, and the like. In addition, devices described herein may be intended for use in a wide variety of settings, including home use and use in an eye doctor's office, medical clinic, or other health care setting.

[00119] In some embodiments, power converter module 120 may alternatively be a broad spectrum lamp, such as an incandescent, xenon, or halogen lamp. Such broad spectrum lamps can be used in combination with one or more color filters to remove certain wavelengths that are not necessary to treat an eye disease, or to remove certain wavelengths that may be harmful to treated tissue in the target area (eg, meibomian glands 18) of the eye system 10 during application of energy from the energy converter module 120 to the tissue being treated.

[00120] In some embodiments, the energy emitted from the power supply module 110 may be converted to visible light and may be emitted by the LED emitter 207. For some embodiments, it is desirable to use light with a wavelength selected to: a) penetrate the eyelid to a depth meibomian gland (e.g., typically approximately 1-2 mm in some individuals) or other adjacent target eyelid tissue and absorption there, b) minimizing the amount of light penetrating the eyelid tissue, and c) minimizing the amount of heat generated at surface of the eyelid. For example, in some embodiments, the LED emitter 207 may emit light having a wavelength in the range of 400-700 nm. In some embodiments, the LED emitter 207 may emit light representing substantially one color selected to optimally treat the meibomian glands 18 in the eye system 10. In some embodiments, the LED emitter 207 may emit light over a range of wavelengths, with the wavelength selected based on the treatment requirements of the patient or based on the intended purpose of a particular step in a multi-step treatment regimen.

[00121] In some embodiments, a light source emitting wavelengths in the range of 500-600 nm is selected. There are many considerations that may come into play when selecting wavelengths in the 500-600 nm range. For example, a given range may be selected to achieve the highest absorption of light rays in the tissue. Light energy falling on the skin of mammals is reflected, transmitted, or absorbed. Reflection depends on the properties of the skin, wavelength and angle of incidence. Light rays that reach the skin surface perpendicular to the surface plane are reflected to a lesser extent than those that reach the skin at an oblique angle. The transmission of light through the skin depends on internal scattering, wavelength and absorption. Internal scattering depends on the chemical and physical properties of the skin and underlying tissues. Eyelid thickness, keratinocyte density, collagen, and fat may play a role. Absorption primarily depends on the concentration and distribution of certain molecules called chromophores, which tend to selectively absorb light of certain wavelengths. In human skin, the main chromophores that absorb light in the visible region of the spectrum are oxyhemoglobin, deoxyhemoglobin, various melanins and, to some extent, water. Water essentially does not absorb light with wavelengths up to the deep red and infrared portions of the spectrum. Melanins generally have a fairly high degree of absorption in the visible spectrum, which gradually narrows as the wavelength increases. Two absorption peaks for oxyhemoglobin are observed at approximately 532 nm and 577 nm. The peak of deoxyhemoglobin is at approximately 550 nm.

[00122] In various embodiments, the choice of wavelengths is also influenced by technical limitations. The selected wavelength is a wavelength that can be emitted by the device that can be easily obtained in a practical configuration with power consumption and physical implementation suitable for a device delivering light energy to the eyelid. For very high power LEDs, there are currently limited choices available, although future improvements are likely. For example, LED Engine Inc. (San Jose, Calif.) produces green LEDs in 10-watt versions such as the LZ4-00G108, which have a nominal center/peak wavelength of approximately 523 nm. Also available in limited quantities with peak wavelengths of approximately 527 nm and 532 nm.

[00123] Various embodiments emit wavelengths in the 500-700 nm portion of the visible spectrum to produce the desired tissue heating effect without excessive transmission through the eyelid (and subsequent unwanted heating of structures behind the eyelid) and without excessive surface heating. In addition, emitted wavelengths in this portion of the visible light spectrum exclude undesirable portions of the electromagnetic spectrum for non-scleral shield embodiments, including ultraviolet, infrared, and blue.

[00124] In some embodiments, longer wavelengths of light are used to penetrate deeper into tissue. For example, light in the “red” and near-infrared (NIR) ranges with wavelengths of 700-1000 nm passes more easily through the eyelid, penetrating deeper than wavelengths in the ranges described above. There is an "optical window" of human tissue of approximately 800-900 nm in which energy passes most efficiently through the tissue and eyelids due to the fact that the chromophore absorption is at its lowest level. For the application of light therapy to the eyelids without the use of a scleral shield, NIR is more likely not to be used due to excess light energy passing through the eyelid directly into the eye, possibly affecting the sensitive tissues of the eye. However, when using a scleral shield to protect the eye, NIR can be preferentially used to pass through the eyelid. For example, 850 nm NIR can pass through the eyelid and be absorbed by the scleral shield, which in turn can heat adjacent tissue on the inner surface of the eyelid. For completeness of discussion, it should be noted that some wavelengths of the short and mid-wave infrared (sometimes called IR-R and IR-S) have higher absorption levels in water than the highest total absorption of the other chromophores discussed above. In particular, it was shown that a wavelength of 3000 nm has such high absorption. Thus, there may be embodiments in which this wavelength or other wavelengths in this band are safely used with or without a scleral shield. It should be noted that at such long wavelengths there are other "optical windows" (in addition to the aforementioned 800-900 nm window) that may be advantageous for use in some embodiments.

[00125] In some embodiments, a light source emitting blue or violet light in the 400-450 nm range can be used to reduce and/or eliminate bacteria in the eye system 10. Exposure to visible light, particularly light with wavelengths in the blue or violet region, is known to inactivate certain types of bacteria. Common bacteria include S. aureus, S. epidermidis, B. oleronius and P. acnes. There may be many considerations when selecting wavelengths in the 400-450 nm range. For example, it is important that the emitting source (LED) does not emit significant amounts of energy below approximately 400 nm, which is in the long-wave UV spectrum and may be associated with skin cancer.

[00126] In another embodiment, one or more wavelengths of light may be selected that are preferentially absorbed by the exoskeleton, internal structures, or eggs of Demodex mites to kill, inactivate, or interrupt reproductive processes.

[00127] In some embodiments, a light source can be used to indicate tear film thickness and stability characteristics. For example, the energy converter module may contain a cobalt blue source, and the imaging means 160 (e.g., an eyepiece) may contain a yellow Wratten filter, and fluorescein eye drops may be provided to the patient, whereby the clinician can measure tear film breakup time by observing the ocular surface through Wratten filter. Alternatively, different wavelengths of photon energy can be delivered to or across the surface of the eye in the presence or absence of tracer eye drops, and the stability and/or thickness of the tear film and/or lipid layer can be determined by either direct visual observation or image capture and processing.

[00128] In another embodiment where LEDs are used as the illumination source, LED emitter 207 may include one or more multi-spectral LEDs or multiple LEDs for emitting light of different or the same wavelength from each LED. In some embodiments, each LED of the LED emitter 207 is configured to emit light of a different wavelength. The LED emitter 207 may emit light from each LED of a different color either sequentially or simultaneously. For example, in some embodiments, the LED emitter 207 may comprise a red, green, blue (RGB) LED system or other multi-spectral LED system for emitting light of various wavelengths in the visible light spectrum and the IR spectrum. In some embodiments, the LEDs of the LED emitter 207 may be configured to operate simultaneously to emit white light. Alternatively, in some embodiments, the user may select the wavelength of light to be emitted from the multispectral LEDs. In addition, the LED can be manufactured using a special phosphorescent coating to obtain the most efficient output spectrum relative to the input power.

[00129] In some embodiments, the LED emitter 207 may comprise a high intensity LED array. The high intensity LED array as part of the LED emitter 207 in some embodiments can operate at an input power in the range of approximately 0.5-75 W, but preferably in the range of 1-10 W. To help maintain the temperature of the power converter module 120 within functional limits, a thermal control structure 220 (such as a heat sink or other significant thermal mass) may be thermally coupled to the LED emitter 207. In a specific embodiment, the high intensity LED array may emit light having a wavelength of approximately 500-600 nm.

[00130] Energy converter module 120 in some embodiments may provide electromagnetic energy to the tissue being treated in the form of infrared energy, such as the NIR band, as described above. For example, LED emitter 207 may be a commercially available LED such as LZ4-00R408, which emits 850 nm NIR and is manufactured by LED Engin, Inc. (San Jose). Additionally, the energy converter module 120 may be another infrared energy source instead of an LED light source, such as an incandescent, xenon, halogen, cold incandescent, or broad spectrum halogen lamp, configured to radiate infrared energy to the tissue site being treated.

[00131] The eye treatment device 200 may include a reflector (such as reflector 210 in other embodiments described below) that can act as a waveguide to direct electromagnetic energy (eg, light) emitted from the power converter module 120. The reflector may be adapted to direct electromagnetic energy uniformly from a point source, such as, for example, LED emitter 207, through the energy transfer surface 140 to a target patient treatment site.

[00132] The energy converter module 120 may include an LED lens 208 that may be used in conjunction with an LED emitter 207 or other electromagnetic energy source to direct energy to the eyelid at a desired angle or pattern and at a desired intensity.

[00133] In FIG. 3A shows an energy transfer surface 140 forming a part of the eye treatment device 200. The power transfer surface 140 is configured to be relatively movable along a movement path 145 relative to the power converter module 120. The energy transfer surface 140 may be located in the housing 202 at a location remote from the energy converter module 120 and located between the energy converter module 120 and the tissue portion of the eye system 10 being treated. When so positioned, the power transmission surface 140 can transmit, or receive and transmit, electromagnetic energy transmitted from the power converter module 120. In some embodiments, the energy transfer surface may be concavely shaped (relative to the eye treatment device 200) such that the energy transfer surface 140 conforms to the shape of the closed eyelids 12, 14. The energy transfer surface 140 may be shaped such that any electromagnetic energy emitted from the power converter module 120 must pass through the power transfer surface 140.

[00134] In some embodiments, the energy transfer surface 140 is located adjacent to the eyelids 12, 14 and is not in physical contact with the eyelids 12, 14, but instead transfers heat to the tissue being treated through radiation. The energy transfer surface 140 may be substantially transparent to the desired electromagnetic energy transmitted by the energy converter module 120 to allow energy to be transferred from the energy converter module 120 without significantly preventing the energy of the desired type or wavelength from reaching the tissue being treated. In some embodiments, the energy transfer surface 140 may be made of optical plastic, sapphire, glass, calcium fluoride, or fiberglass. It may have an easy-to-clean outer surface and may be resistant to mechanical contact damage. Optionally, a temperature sensor 310 may be located on, within or adjacent to the energy transfer surface 140 to provide temperature feedback to the energy transfer surface 140 and/or the outer surface of the eyelid.

[00135] In some embodiments, the energy transfer surface 140 may be configured to operate in conjunction with the energy converter module 120 to filter out unwanted wavelengths from reaching the tissue being treated or other parts of the eye system 10. For example, in some embodiments, the light source may transmit electromagnetic energy in both the IR and visible light spectrum. The energy transfer surface 140 may be used to allow the passage of, for example, energy from the visible light spectrum, but filter out energy from the IR spectrum. Likewise, if only energy from one color is desired to reach the tissue being treated, energy transfer surface 140 can be used as a bandpass filter or used with a filter to limit the passage of energy of wavelengths other than the desired color.

[00136] In some embodiments, the energy transfer surface 140 may be adapted to come into physical contact with the eyelids 12, 14. As discussed above, in some embodiments, the energy transfer surface 140 may be configured to be relatively movable along a movement path 145 relative to the module 120 energy converter. This allows the energy converter module 120 to be in fixed relationship with the eyelid while the energy transfer surface 140 can move forward into contact with the eyelids 12, 14. Alternative approaches to reducing the space between the outer surface of the eyelids 12, 14 and the surface 140 are possible. energy transfer. For example, the energy converter module 120 and the energy transfer surface 140 may move together toward the eyelids while the scleral shield 300 remains in a relatively stationary position, or the scleral shield 300 may move relative to other parts of the device. In any case, the movement is preferably performed manually by the clinician to provide the clinician with some degree of tactile feedback. In some embodiments, the eye treatment device 200 may include an actuator 182, such as a lever, button, wheel, slide, or switch, for moving the energy transfer surface 140.

[00137] In some embodiments, at least a portion of the energy transfer surface 140 may be configured as a disposable cover member or outer eyelid liner 147, as shown in FIG. 3A. Preferably, such outer eyelid pad 147 is integrated into the consumable part 260 of the device, with the outer eyelid pad 147 automatically aligned and seated on the power transfer surface 140 when the consumable part is attached to the housing 202.

[00138] In some embodiments, the energy transfer surface 140 may be heated to transfer heat to the tissue being treated through conduction. In other embodiments, most of the heating of the tissue occurs as a result of heating through radiation produced by the energy converter module 120 to the tissue and/or scleral shield 300, with substantially all of the required electromagnetic energy passing through the energy transfer surface 140 with little heating of the transfer surface 140 energy or without it. In still other embodiments, tissue heating may result from a combination of conductive heating caused by preheating or active heating of the energy transfer surface 140 and heating of the tissue and/or scleral shield by radiation. The energy transfer surface 140 may comprise an energy-absorbing layer or structure that may be preheated by light energy or other means, for example to 42 degrees Celsius, before coming into contact with the outer surface of the eyelid. Alternatively, the power transfer surface may be made of a thermally conductive material and may be heated by a heater thermally coupled to the power transfer surface 140. In the case where the energy transfer surface 140 is made of a thermally conductive material, the material may be conductive for the energy source (such as light) coming from the energy converter module 120, or may be solid, opaque, or otherwise non-transmitting energy in a form other than from heating by conduction. In the case where the power transfer surface 140 is opaque or non-transmitting, it may be made of a conductive metal such as copper or aluminum, in which case the power transfer surface 140 may be heated by a power converter module 120 comprising any thermal mass heating means (such like a resistive heater) and then pressed against the eyelid to heat the eyelids by conduction. In the case where the energy transfer surface 140 is transferable to another form of energy as well as thermally conductive, it may be made of materials such as sapphire, calcium fluoride, diamond, graphene, and the like. In one preferred embodiment, heating may occur simultaneously in three modes: i) the inner surface of the eyelid is heated using red or infrared light transmitted to the energy-absorbing scleral screen 300, ii) the eyelid tissue is heated by irradiating visible light (e.g., green), which is absorbed chromophores, and iii) the eyelid tissue is heated by conduction by bringing the preheated energy transfer surface 140 into contact with the outer surface of the eyelid. It will be appreciated that the significant advantage of using the light-based heating techniques described herein, and in particular infrared heating of the energy-absorbing surface, alone or in combination with two other heating modes (visible light heating of chromophores and conductive heating of tissue), heating the target tissue can be achieved much faster than with any traditional method of heating the outer or inner surfaces of the eyelid by conduction. In particular, using these combination modes, meibomian gland tissue can be brought to a temperature of, for example, approximately 40-42 degrees Celsius in less than one minute. In particular, in some cases, meibomian gland tissue can be brought to a temperature of approximately 40-42 degrees Celsius in 10, 15, 20, 25, 30 or 45 seconds.

[00139] As shown in FIG. 3A, an imaging device 160 or means may be used to examine the eyeball 20. In some embodiments, the imaging tools 160 may be part of the eye treatment device 200. In other embodiments, renderers 160 may be a separate component. The imaging means 160 may include, for example, a magnifier, camera, microscope, slit lamp, or other suitable imaging device.

[00140] In some embodiments, the scleral screen 300 may further include an image transducer 155 that provides the ability to view a translucent image of a portion of the eyelid and meibomian glands. As previously described, the image converter may comprise, for example, one or more reflective surfaces, mirrors, optical waveguides, prisms, fiber tows, image sensors, or other suitable image converter means. As shown in FIG. 3A, the image converter 155 is integrated into the scleral screen 300, but in other embodiments, the image converter 155 may be a separate component.

[00141] In some embodiments, an additional shielding element 258 may be used to prevent unwanted photon energy (such as IR or blue/violet light) from being reflected from the transilluminated element back to the clinician. For example, the shielding element 258 may be a thin, opaque screen or filter (blocking at least visible blue and IR light energy) that rotates, flips, or slides (as indicated in FIG. 3A) into position in front of the image converter 155 and optionally also by the energy converter module 120 or energy transfer surface 140 during heating and blue/violet light treatment modes to protect the clinician. Alternatively, the image transducer and/or imaging portion 155 may include a selective optical filter or photochromic element such that during low-level eyelid illumination for purposes of assessing transillumination images of the meibomian glands, the photochromic element transmits substantially all light, whereas during the heating mode, when in which infrared energy or high-level visible light may be used, some or all of this energy may be attenuated, thereby shielding the clinician from harmful effects.

[00142] For further explanation, several classes of embodiments will be described below. In one class of embodiments, devices are intended for self-administration by individuals, typically in a home environment. For this class, scleral shields are not required for practical use, so there may be a high risk of unwanted forms of energy (such as certain wavelengths of light or infrared energy) penetrating the eyelids and reaching sensitive structures of the eye. As such, embodiments of this class may sometimes be limited to using safer forms of energy, such as visible light in the 450-700 nm range. In another class of embodiments, the devices are intended for use by ophthalmologists in a controlled outpatient setting, where a treatment system comprising a scleral shield component is more likely to be safely used. In this class, the scleral shield may be constructed in such shapes and materials as to increase the likelihood that the damaging energy will reach the sensitive structures of the eye to little or no extent.

[00143] OUTPATIENT DEVICE. Embodiments of an ambulatory device may include one or more of the following: diagnosing meibomian glands; treatment of meibomian glands; and antimicrobial treatment of the ocular system. In one set of preferred embodiments, diagnosis of meibomian glands is accomplished in two ways. First, using visible or IR illumination from the energy converter module, which is directed towards the outer surface of the eyelid, to examine and evaluate the meibomian glands using an image converter with or without imaging aids. Secondly, by gently squeezing the eyelid while observing the edges of the eyelid to note the quantity and quality of oily discharge from the meibomian gland ducts. For treatment, in one set of embodiments, the eyelid is heated and compressed. Near-infrared (NIR) energy from the energy converter module at approximately 800-900 nm is passed through the eyelid to the scleral shield, which is then heated and therefore heats the inner surface of the eyelid. Additionally, visible light from the energy converter module in the range of approximately 500-600 nm (green light) is directed to the outer surface of the eyelid, which heats the tissue through absorption by chromophores. The clinician then moves the energy transfer surface toward the eyelid using direct or indirect manual control to compress the eyelid between the energy transfer surface and the scleral shield. Optionally, the energy transfer surface may be preheated and/or actively heated during treatment to provide some conductive heating to the outer surface of the eyelid. The temperature of the inner and/or outer surface of the eyelid can be measured and displayed to the clinician. The clinician applies heat and compressive force while visually observing the eyelid margin to optimize the release of meibomian gland secretions from obstructed meibomian glands. Finally, the energy converter module can produce blue/violet light in the range of approximately 400-450 nm to reduce and/or kill bacteria in the eye system 10.

[00144] DEVICE FOR HOME USE. Embodiments of the home device use visible light transmitted through an energy transfer surface from an energy converter module directed at the outer surface of the eyelid to heat the tissue through absorption by chromophores. In some preferred embodiments, the visible light may be broad-spectrum, high-intensity (e.g., white) LED light passing through certain filters, or it may be a green, greenish-yellow, or greenish-white LED (500-600 nm) without filters . In some embodiments, the energy transfer surface is transparent to visible light and thermally conductive, allowing heating (eg, up to 42 degrees Celsius) before or while the surface is pressed against the eyelid (see FIG. 2A). In some embodiments, the energy transfer surface may have an additional element 143 (such as in FIG. 2B and described previously) that allows most of the light energy to pass through it while maintaining a gap between the energy converter module and the eyelid surface 12, 14 ( for example, to provide passive or active air cooling of the eyelid). The energy transfer surface can conform to the shape of the eyelid and exert pressure on the eyelid surface to shorten the optical path length of the radiation energy. In some embodiments, eye cups are used to prevent light from escaping from the immediate treatment area and to keep at least a portion of the device at a predetermined distance from the eyelids or periocular area.

[00145] In FIG. 4A-4C illustrate another embodiment of an eye treatment device. In fig. 4A is a schematic side plan view of an eye treatment device 200. The eye treatment device 200 shown in FIG. 4A is positioned adjacent to the eyeball 20 for treating the eyeball for MGD, blepharitis and other diseases. For simplicity, the sensory structures of the eye, such as the cornea, iris, pupillary lens, and adjacent elements, are depicted in FIG. 4A-D, 5A-B, 6, 11A-B, 12, 13 and 15A as a single element called the anterior eye structures 27. The eye treatment device 200 may include the configurations of modules shown in FIG. 2 and 3, together with additional components used in the operation of the eye treatment device 200. The eye treatment device 200 may include a power supply module 110, a control device 212, a power converter module 120, a reflector energy waveguide 210, and a power transmission surface 140. The power converter module 120 in some embodiments may include an LED device formed by one or more of an LED emitter 207, an LED lens 208, and a power converter module driver 209. Each of these components, either alone or in combination with other components (shown herein or not) may correspond to the modules described with reference to FIGS. 2A-2H, or be part of them. Components of the eye treatment device 200 may be contained in a housing 202. Some embodiments of the eye treatment device 200 may also include a dispenser 260 and/or a scleral shield 300, such as those shown in FIG. 3 and 6.

[00146] The power converter module driver 209 may include any LED power and control circuitry implemented as an actual printed circuit board, integrated circuit, or discrete components. In some embodiments, it functions as an LED driver that supplies a controlled current, voltage, or power level through the LED emitter 207 within the LED's specifications to produce the required lighting intensity from it. Optionally, the LED circuit board may include a pulse width modulation function, PID circuit, or similar circuitry for modulating the effective irradiation intensity as a function of time to achieve the desired heating of the target area of the eyelid.

[00147] The energy transfer surface 140 may be located relative to the body 202 at a location remote from the energy converter module 120 and located between the energy converter module 120 and the tissue portion of the eye system 10 being treated. When so positioned, the power transmission surface 140 can transmit, or receive and transmit, electromagnetic energy transmitted from the power converter module 120. The energy transfer surface may have a concave shape such that the energy transfer surface 140 conforms to the shape of the eyelids 12, 14 when they are closed and covering the eyeball 20. The energy transfer surface 140 may be an integral part of the housing 202 and may substantially seal the distal end of the device 200 for eye treatment. Additionally, the power transfer surface 140 may move independently or in conjunction with the power converter module 120 relative to the housing 202. A sealing member, such as a bellows, gasket, O-ring, or similar sealing means, may be used to prevent contamination of the interface between the moving members and the housing.

[00148] In some embodiments, the energy transfer surface 140 is located adjacent to the eyelids 12, 14 and is not in physical contact with the eyelids 12, 14, but instead transfers heat to the tissue being treated through radiation. The energy transfer surface 140 may be substantially transparent to the desired electromagnetic energy transmitted by the energy converter module 120 to allow thermal energy to be transferred from the energy converter module 120 without significantly preventing the energy of the desired type or wavelength from reaching the tissue being treated. In some embodiments, the energy transfer surface 140 may be made of optical plastic, sapphire, glass, calcium fluoride, or fiberglass. It may have an easy-to-clean outer surface and may be resistant to mechanical contact damage. In some embodiments, the energy transfer surface 140 may be configured to operate in conjunction with the energy converter module 120 to filter out unwanted wavelengths from reaching the tissue being treated or other parts of the eye system 10. For example, in some embodiments, the light source may transmit electromagnetic energy in both the IR and visible light spectrum. The energy transfer surface 140 may be used to allow, for example, energy from the visible light spectrum to pass through, but filter out energy from the IR spectrum. Likewise, if only energy from one color is desired to reach the tissue being treated, the energy transfer surface 140 can be used as a bandpass filter or used with a filter to limit the passage of energy of wavelengths other than the desired color. Alternatively, as previously described, the energy transfer surface 140 may include a disposable outer eyelid liner 147. Such outer eyelid pad 147 may be transparent to all relevant wavelengths of light or other forms of energy, or it may have desired filtering properties, and it may further comprise a temperature or pressure sensor.

[00149] In some embodiments, the energy transfer surface 140 may be adapted to come into physical contact with the eyelids 12, 14 and may conductively transfer heat to the tissue being treated (or assist in cooling the eyelid, as described below). In other embodiments, the predominant heating of the tissue results from heating by radiation from the energy converter module 120, with substantially all of the required electromagnetic energy passing through the energy transfer surface 140 and being absorbed by the tissue, thereby causing heating of the tissue and little or no heating of the energy transfer surface 140 leading to heating of the latter. It will be appreciated that the device may be configured without the power transfer surface 140. However, the energy transfer surface 140 provides certain advantages, such as ease of cleaning of the primary patient contact surface, as well as the possibility that the energy transfer surface 140 will help maintain the temperature of the outer surface of the eyelid within the desired temperature range and provide convenient placement of certain safety sensors. In embodiments where the disposable outer eyelid pad 147 is used as part or all of the energy transfer surface 140, the outer eyelid pad 147 may include a temperature sensor, but preferably a non-contact temperature sensor such as a thermoelectric battery or a pyroelectric sensor located closer is used instead. (relative to the body) to the outer gasket 147 for the eyelid. In such embodiments, the outer eyelid pad 147 is preferably transparent to the infrared wavelengths that the non-contact temperature sensors are designed to sense.

[00150] In FIG. 4B is a schematic front plan view of a power converter module 120 of an eye treatment device 200. As shown in FIG. 4B, LED emitter 207 may be arranged as an array of individual LEDs. As illustrated, LED emitter 207 is arranged as a 3x3 array of LEDs (for example, in the LZ9 configuration offered by LED Engine, Inc.), although LED emitter 207 is not limited to this arrangement and may include arrays of varying numbers of LEDs arranged in different matrices of columns and rows; and some embodiments may include a single LED or other type of lighting source. The reflector 210 may partially or completely surround the LED emitter 207 so that it can direct light emission from the LED emitter 207 in a desired manner. The LED lens 208 may be positioned above the LED emitter 207 and located within the inner diameter of the reflector 210.

[00151] In FIG. 4C is a schematic side plan view of one embodiment of an eye treatment device 200 in which the device operates and transmits light 211 to the eye system 10 and the tissue being treated. In fig. 4C, light 211 is emitted from the power converter module 120. Some of the light 211 may initially be emitted at an angle such that the uncorrected light does not reach the energy transfer surface 140 to travel to the tissue being treated. As shown, the reflector 210 may reflect or direct oblique light toward the energy transfer surface 140, thereby increasing the efficiency of heating the target tissue. Portions of light 211 may also be transmitted directly from power converter module 120 to power transfer surface 140 .

[00152] In FIG. 4D is a schematic side plan view of another embodiment of an eye treatment device 200. In this embodiment, transmission of light 211 can be accomplished without the aid of reflector 210 if, for example, other components of eye treatment device 200, such as a specially shaped lens, an additional lens element, a light guide, a complete lens element, can be used to control the direction and intensity of light 211. internal reflection (TIR), refractive element, diffractive element, mirror element, diffuser, etc., or a combination thereof. It may be desirable to control the focus and intensity of the light energy so that the light energy penetrates deep into the target tissue of the eyelids 12, 14, such as the meibomian glands, but not significantly beyond it. In some embodiments, the energy transfer surface 140, acting as or with a lens, can be used to focus and direct light 211 onto the tissue requiring treatment and away from the central ocular axis to avoid the anterior ocular structures 27 of the eyeball 20 and other sensitive structures of the eye. , such as the retina. It will be understood that the area along which the upper eyelid 12 and lower eyelid 14 meet may vary from one person to another; in most people this area is usually below the central ocular axis. However, for the purpose of demonstrating how certain embodiments can reduce the risk of excess light 211 passing through the eyelids along the central ocular axis, a worst-case situation is shown where the eyelids are closed at the central ocular axis. It will also be understood that at least part of the risk associated with excessive penetration of rays through the eyelids and reaching sensitive tissues can be reduced by the person being treated moving his eyeball off-axis so that most of the rays penetrating through eyelids, reaches only the sclera, which is usually less sensitive.

[00153] In FIG. 4E shows a specific embodiment containing additional optical elements to improve the distribution of light energy across the surface of the eyelid while minimizing the amount of light passing directly through the central ocular axis. The power converter module 120 includes an LED, such as LZ9 from LED Engin Inc., a prism 280, a forming lens 282, and a face glass 284 (performing a similar function to the power transfer surface 140 in another embodiment disclosed herein). Eyelids 12, 14 and eyeball 20 are also shown in relation to the optical elements. In this particular design, the prism is a glass element with 6 polished surfaces and one concave hemispherical surface with a 3.5mm radius to accommodate the LED. There is no coating on the surface of the prism. The inlet and outlet surfaces may have an anti-reflection coating (optional), which increases efficiency by approximately 5-6%. Fig. 4F-H show illustrative details of the shape and dimensions of the prism 280. The material may be BK7 and the surfaces are preferably polished. In fig. 4F is a front view; FIG. 4G is a side view, and FIG. 4H is a sectional view along section line A-A. In fig. 4I-L show illustrative details of the shape and dimensions of the shaping lens 282. FIG. 4I is a front view; FIG. 4J is a sectional view along section line A-A, FIG. 4K is a side view, and FIG. 4L is a perspective view. In fig. 4M and 4N show the theoretical optical characteristics of the system described above in FIG. 4E-L. In fig. 4M shows the light distribution measured as irradiance in watts per square millimeter on the surface of the eyelids, showing that the light distribution is fairly uniform (as opposed to the LED of the power converter module 120 shining directly onto the eyelids or through a smooth glass energy transfer surface, in the case whereby most of the light will be projected in the middle of the eyelid and very little will reach the edges). The total calculated flux is 0.86 W, the maximum irradiance is 2.2 milliwatts per square millimeter, and the uniformity is estimated to be approximately 80%. In fig. 4N shows the amount of radiation reaching the eye (that is, passing through the tissue of the eyelid). The total design flux is 0.019 W and the maximum irradiance is 0.18 milliwatts per square millimeter.

[00154] In FIG. 5A and 5B illustrate one embodiment of an eye treatment device 200. In fig. 5A is a schematic side plan view of an eye treatment device 200, and FIG. 5B is a schematic front plan view of an eye treatment device 200. An embodiment of the eye treatment device 200 may include components similar to those shown in FIG. 4A-4C, including power supply module 110 and control device 212, although such components are not shown in FIG. 5A and 5B. In fig. 5A provides another configuration of a power converter module 120 for focusing and controlling the direction of light 211. In some embodiments, the eye treatment device 200 may include multiple power converter modules 120 such that at least one power converter module 120a may be located in an upper region of the device. 200 for treating the eye for delivering electromagnetic energy (e.g., light 211) to the target tissue within the upper eyelid 12, and at least one energy converter module 120b may be located in the lower region of the device for treating the eye 200 for delivering electromagnetic energy (for example, light 211 ) to the target tissue located in the lower eyelid 14. The presence of separate energy converter modules 120a, 120b located separately in the eye treatment device 200 allows the eye treatment device 200 to direct light energy directly to the target tissue within the upper eyelid 12 and lower eyelid 14 and reduces the amount of light that can be directed to the sensory anterior structures of the eye 27 along the central ocular axis 30.

[00155] As shown in FIG. 5A, use of the eye treatment device 200 to treat eye diseases such as MGD and blepharitis may include placing the energy transfer surface 140 of the eye treatment device 200 adjacent or in contact with the closed upper and lower eyelids 12, 14 of the patient. With this arrangement of the eye treatment device 200, the upper energy converter module 120a may be located above the central ocular axis 30 to supply electromagnetic energy in the form of light 211 to the meibomian glands 18 within the upper eyelid 12, and the energy converter modules 120b may be located below the central ocular axis 30 for delivering electromagnetic energy in the form of light 211 to the meibomian glands 18 within the lower eyelid 14. The eye treatment device 200 may also include a reflector 210 located behind the upper and lower energy converter modules 120 to reflect any light back to the tissue being treated.

[00156] As shown in FIG. 5A, the upper and lower energy converter modules 120 may be tilted at some angle, each having a central optical axis directed at a substantially oblique angle to the surface of each eyelid such that the majority of the light energy passing into each eyelid is absorbed before as it reaches the sensory anterior ocular structures 27 of the eyeball 20. In some embodiments, the upper and lower energy converter modules 120 may have a different directional orientation. For example, in some embodiments, the upper and lower power converter modules 120 may be positioned such that each central optical axis of the light sources is substantially horizontal. As such, light 211 transmitted from power converter modules 120 so configured may pass horizontally from power converter modules 120 to power transfer surface 140 and may then be subject to refraction, diffraction, or reflection at an angle to the tissue being treated so as to maximize increase penetration, absorption and heating in targeted areas of the eyelids, while minimizing the proportion of light that reaches the sensitive anterior structures of the 27 eye.

[00157] The eye treatment device 200 in the embodiments shown in FIGS. 5A and 5B may include more than one power converter module 120 in each of the upper and lower regions of the eye treatment device 200. For example, as shown in FIG. 5B, the eye treatment device 200 may include three separate power converter modules 120a-c in an upper region and three separate power converter modules 120d-f in a lower region. Another number of power converter modules 120 is contemplated, such as, for example, 2, 4, 5, 6, 7, 8, 9, 10, etc. power converter modules 120 in each of the upper and lower regions of the eye treatment device 200 . Placing multiple energy converter modules 120 laterally in the upper and lower regions of the eye treatment device 200 provides the ability to improve the coverage and distribution of electromagnetic energy across the width (side to side) of the upper and lower eyelids 12, 14 to better cover the entire width of the target tissue (e.g. meibomian glands inside the eyelids 12, 14). Also, as shown in FIG. 5B, the upper and lower power converter modules 120a-c, 206d-f may be arranged in an arc pattern to follow the upper and lower contours of the eyeball.

[00158] Also implied, although not shown in FIG. 5B that the upper and lower illumination areas of the eye treatment device 200 may be equipped with more than one row of power converter modules 120. For example, in FIG. 5B, one or more additional power converter modules 120 may be located above or below each of the power converter modules 120a-c. Incorporation of additional rows of energy converter modules 120a-c may provide additional vertical coverage and distribution of electromagnetic energy directed toward the target tissue being treated. It is further implied, although not shown, that the eye treatment device 200 may include two sets of energy converter modules 120, reflectors 210, and energy transfer surfaces 204 within a binocular-like housing for placement adjacent to or opposite both of the patient's eyes. simultaneously. Devices according to such embodiments can speed up treatment time since both eyes can be treated simultaneously.

[00159] In FIG. 5C-F show side, top, front and perspective views, respectively, of an 8-LED configuration similar to that shown in FIG. 5A-B (with only eight 120a, 120b LEDs instead of six). The eight LEDs 120a, 120b may be LZ1 type LEDs from LED Engin, Inc. and are shown located on a spherically curved surface, which may be a circuit board or power converter module driver 209, located behind a bezel 284 shaped to match the curvature of eyelids 12, 14 adjacent to the eyeball 20. In FIG. Figure 5G shows the calculated irradiance pattern for eyelids 12, 14 with a total flux of 2.7 W and a maximum irradiance of 10.7 milliwatts per square millimeter. In fig. Figure 5H shows the calculated irradiance through the eyelids, with a total flux of 0.07 W and a maximum irradiance of 0.6 milliwatts per square millimeter. It will be understood that the irradiance patterns shown in FIG. 5G and 5H are less uniform than the patterns shown in FIG. 4N and 4P. The trade-off between the two designs is due to the dependence of device compactness on uniformity. The structures shown in FIGS. 4E-L contain a fairly large prism, while the designs shown in FIGS. C-F, do not contain any optical elements other than LEDs, lenses and front glass. Those skilled in the art may combine these two approaches, for example, by adding one or more prisms 280, forming lenses 282, or other elements such as diffusers, gratings, and the like, to the structures illustrated in FIGS. 5C-F, with the aim of optimizing the uniformity of light distribution while keeping the size of the device as compact as possible.

[00160] In FIG. 6 is a schematic side plan view of an eye treatment device 200, such as the eye treatment device 200 shown in FIG. 5A. Also in FIG. 6 illustrates a scleral shield 300 that, when combined with an ocular treatment device 200, can provide a system for treating target tissue with increased safety and effectiveness. The scleral shield 300 may be positioned under the eyelids 12, 14 and adjacent to the eyeball 20 of the patient to cover the sensory anterior structures 27 of the eye. For example, a scleral shield may be located (with reference to FIG. 1) over the sclera 21 and cornea 22, and may also provide protection to other internal structures of the eye, such as the iris 24, pupil 25, lens 26, and other light-sensitive structures of the eye system 10 .

[00161] Returning again to FIG. 6, the scleral shield 300 may be disc-shaped like a contact lens, or it may be significantly larger to cover the entire cornea and optionally at least part of the sclera (as with a conventional corneal shield), or it may be in the shape of a partial disc or scapula, similar to the part of Mastrota's scapula placed under the eyelid. The screen 300 may be positioned in the eye prior to treatment with the eye treatment device 200, or it may be integral with the eye treatment device 200 and therefore placed in the eye or under the eyelid during treatment. In addition to providing basic safety benefits, the scleral shield 300 may also provide increased effectiveness of the eye treatment device 200. For example, in some circumstances, the intensity of the energy emanating from the energy converter modules 120 must be modulated to prevent damage to the sensitive structure of the eye; however, when the ocular structure is protected by the scleral shield 300, the intensity of electromagnetic energy directed from the energy converter modules 120 can be increased. As shown in FIG. 7E-7G, scleral shield 300 may include an upper curved shield portion 264 that prevents scattered photon energy from reaching the cornea, lens, iris, and pupil. Although scleral screen 300 is shown in FIG. 6 for use in conjunction with the embodiment of the eye treatment device 200 described with reference to FIG. 5A and 5B, one of ordinary skill in the art will appreciate that the scleral shield 300 may be used in combination with any of the embodiments of the ocular treatment device 200 disclosed herein to provide a system for the safe and effective treatment of ocular diseases.

[00162] It will also be understood that the scleral screen 300 may include features that provide even more benefits to the device. For example, the scleral shield 300 in some embodiments is configured to reflect energy from the eyeball to the inner eyelids, providing heating to the inner eyelids. In some embodiments, the scleral screen 300 may also include an image converter 155, as discussed above. The image converter 155 provides the ability to view the inside of the eyelid 14 and view the meibomian glands from behind the eyelid. In some embodiments, the scleral shield 300 may be made of an energy-absorbing material or have an energy-transmitting surface on the facial surface 302 to heat the eyelid meibomian glands during treatment. The energy-absorbing material may be a material that absorbs visible light or IR radiation, or a surface made of black plastic or coated with a black substance, either of which may contain carbon black (for example, 5% or more) or other material that absorbs light energy, for example, red light and NIR.

[00163] Additionally, as shown in the schematic front plan views of the scleral shield 300 in FIG. 7A-7H, screen 300 may include one or more temperature sensors 310 on the front or rear surfaces of screen 300. Screen 300 may also include communication means 320 so that temperature data can be sent to eye treatment device 200 for monitoring or monitoring purposes. modulating the treatment session so that the inner surfaces of the eyelids can reach the target temperature without exceeding a predetermined threshold, and also ensure that the sensitive tissues of the eye do not exceed another predetermined threshold. In some embodiments, such as the embodiment shown in FIG. 7A, screen 300 has an integrated power supply 330, a temperature sensor array 310, and communications means 320 that transmit data wirelessly, such as RF, to an external interrogator 400 (which may be built into the eye treatment device 200). In some embodiments, the communication means 320 includes an antenna integrated into the screen 300. In another embodiment, such as the embodiment depicted in FIG. 7B, screen 300 may be passive (without power supply 330) and configured to be interrogated by external interrogator 400 (which may be built into eye treatment device 200) using RF. For example, external interrogator 400, shown schematically in FIG. 7B may be configured to supply circuitry in screen 300 with sufficient power to sense temperature(s); interrogator 400 may also power the transmitter to send temperature data back to interrogator 400. In yet another embodiment, such as the embodiment shown in FIG. 7C, shield 300 may be completely passive and contain one or more temperature sensors 310 in resonant circuits, whose resonance points will be modulated by changes (e.g., resistance) in temperature sensors 310 and whose resonance points can be detected by sweeping an external RF field, e.g. , by using an external RF scanner 410, schematically shown in FIG. 7C, and current monitoring of impedance or other field characteristics. In another embodiment, such as the embodiment shown in FIG. 7D, the screen 300 may be physically coupled to an external device, such as an interrogating device or an eye treatment device 200 (eg, shown in FIG. 3A), via a wire or set of wires 420 extending from the screen 300 to the external device, such the external device may supply power to active elements in the screen 300 and send data to and receive data from the screen 300. The wire or set of 420 wires may contain conventional stranded or solid wires with thin-wall insulation, or they may be embedded in stronger structural insulation.

[00164] In FIG. 7E and 7E are schematic side and front plan views of a shield 300 having a temperature sensor 310 in the middle portion and one wire 420 extending from each side of the shield. The upper curved portion 264 of the shield is used to protect the patient's cornea, lens, iris, and pupil from light or IR energy. Temperature data from the temperature sensor 310 may be sent to the eye treatment device 200 via wires 420 for the purpose of monitoring or modulating the treatment session, ensuring that the inner surfaces of the eyelids reach the desired temperature range without exceeding a predetermined threshold, while ensuring that the sensitive tissues of the eye did not exceed another predefined threshold.

[00165] In FIG. 7G and 7H are schematic side and front plan views of a shield 300 having a temperature sensor 310 in the middle portion and one wire 420 extending from each side of the shield. In these embodiments, the scleral shield 300 may be connected to the housing 202 by one or more brackets 262, with wires located on or within the brackets, and in certain embodiments, the structural portion of the brackets 262 is made of insulating materials surrounding or otherwise guides conductive parts of a wire or set of 420 wires.

[00166] In FIG. 8 is a side view of another embodiment of an eye treatment device 200. In some embodiments, such as the present described embodiment, the eye treatment device 200 is configured to apply energy to one eyelid at a time to further protect eye tissue from damage or discomfort. In such a configuration, the energy converter module 120 in housing 202 is sized to target the meibomian gland and surrounding tissue of one eyelid, such as the upper eyelid 12 shown in FIG. 1, or the lower eyelid 14 shown in FIG. 1, and the power transfer surface 140 is configured to be relatively movable along a movement path 145 relative to the power converter module 120. In such embodiments, the energy transfer surface 140 is also sized to fit along one eyelid at a time. In use, a patient using such an eye treatment device 200 may be instructed to open the eye wide, thereby ensuring that the eyelid is relatively far from the sensitive anterior structures of the eye and the central ocular axis.

[00167] In some embodiments, the eye treatment device 200 includes one or more features that help ensure that the eye treatment device 200 adheres safely and correctly to the eyelid. For example, in some embodiments, the eye treatment device 200 includes a pupil alignment guide 242. The pupil alignment guide 242 may be, for example, a mirror with a circle, X, bullseye, or other target indicator. In use, the patient may be able to correctly position their eye by looking into the pupil alignment guide 242, observing the reflection of their pupil in a mirror, and aligning the pupil with the target indicator. Additionally or alternatively, in some embodiments, the eye treatment device 200 includes a display 244, which may be a screen, digital display, or other optical display. The display may provide, for example, an image that the patient can look at during use, a timer counting down the remaining treatment time, and/or reminder messages such as “Look Up” (explained below). The display 244 may also include visualization tools 160 for enhanced observation of the eyelid margin during diagnosis and treatment.

[00168] The eye treatment device 200 shown in FIG. 8 may contain any or all of the features described in relation to other embodiments presented herein. For example, in the illustrated embodiment, power converter module 120 is an array of infrared LEDs. However, in other embodiments, including other embodiments configured to apply energy to one eyelid at a time, the energy converter module 120 may include an LED emitting light in the visible light spectrum, a laser, an incandescent lamp, a xenon lamp, a halogen lamp, a fluorescent lamp , high intensity discharge lamp or gas discharge lamp. The eye treatment device 200 may further include a scleral shield 300 made of an energy-absorbing material or having an energy-absorbing or energy-transmitting surface on the front surface 302 to absorb or transmit heat and warm the inner surface of the eyelid during treatment. The scleral screen 300 may also include one or more temperature sensors 310 to monitor the treatment session, ensuring that the inner surfaces of the eyelids reach a desired temperature and/or do not exceed a predetermined threshold. The scleral screen 300 may further include an image transducer 155 integrated into the scleral screen to allow viewing of the meibomian glands behind the eyelid. The eye treatment device 200 shown in FIG. 8 preferably also includes a power supply module 110 and optionally a control device 212, along with other components as described with respect to the various embodiments presented herein. Additionally, the eye treatment device 200 shown in FIG. 8, includes a reflector 210. In the illustrated embodiment, the reflector 210 is formed by a cylinder and a back plate that together surround the power converter module 120 in all directions except distally.

[00169] The eye treatment device 200, in various embodiments, also includes one or more thermal control structures configured to cool at least a portion of the device. In some embodiments, thermal control structures are provided to control the heat of the power converter module 120 and prevent the eye treatment device 200 from overheating. Additionally or alternatively, in some embodiments, thermal control structures are provided to cool the surface of the eyelid to limit discomfort and avoid damage to eyelid tissue during treatment. In fig. 8, for example, eye treatment device 200 includes a thermal management structure 220 (shown as a finned heat sink), a thermoelectric (Peltier) module 224, and one or more passively or actively cooled thermally conductive surfaces. In some embodiments, a passive heat sink may be provided as an adequate thermal management structure 220 to dissipate heat from the power converter module 120 to the environment without the need for a thermoelectric module 224. Some embodiments include a thermoelectric module 224 or another type of cooler (e.g., a compact vapor compression cooler ) for cooling the power converter module 120 by transferring heat away from the power transfer surface 140. In fig. 8, thermoelectric module 224 and thermal control structure 220 are connected such that thermoelectric module 224 pumps heat from power converter module 120 to thermal control structure 220 for dissipation. Additionally or alternatively, some embodiments include one or more thermally conductive surfaces. For example, in FIG. The cylinder 8 and reflector back plate 210 are thermally conductive and are connected to both the power transfer surface 140 and the thermoelectric module 224. In addition, the power transfer surface 140 is thermally conductive. As a result, heat from the eyelid surface and energy transfer surface 140 can be transferred to the thermoelectric module 224 to help maintain a comfortable temperature on the eyelid. Active cooling of the energy transfer surface 140 may occur not only during the heat treatment period, but also before, after, or periodically as a means of cooling the eyelids. This feature may not only relieve the burning and itching sensations that often accompany MGD and blepharitis, but may also reduce inflammation of the eyelids.

[00170] In some embodiments, the eye treatment device 200 includes a non-contact temperature sensor 232 for use, for example, in conjunction with one or more thermal management structures. The non-contact temperature sensor 232 may be a remote-sensing infrared thermometer or other suitable temperature sensor. The non-contact temperature sensor 232 may be focused on an area of the eye of particular interest. For example, in FIG. 8, the non-contact temperature sensor 232 is focused on the inferior edge of the cornea and thus provides a temperature reading at the edge of the cornea. The non-contact temperature sensor 232 may be operably coupled to the control device 212 such that, in some embodiments, the control device 212 modulates or disables the power converter module 120 or activates one or more thermal control structures in response to receiving an elevated temperature reading from the non-contact temperature sensor 232. In some embodiments, when heat is applied to the lower eyelid (for example), the display 244 may instruct the patient to “Look Up” to allow the non-contact temperature sensor 232 to measure the temperature of the eye (sclera) at a location that is directly behind the heated portion of the eyelid. In this way, the eye treatment device 200 can continue to heat the eyelid while periodically ensuring that the eyeball does not overheat. It will be understood that the device configuration shown in FIG. 8 can be easily adapted for upper eyelid treatment, for example, by reversing the orientation of the power delivery elements while maintaining the display 244 and alignment elements in their vertical (readable) orientation.

[00171] In FIG. 9 is a side view of another embodiment of an eye treatment device 200 having one or more thermal control structures 220. Any of the thermal control structures 220 described with reference to FIGS. 8 or 9 is suitable for use and is expressly suggested for use with any of the embodiments of the eye treatment device 200 described herein. The thermal management structure 220 may include any suitable structure configured to remove heat from the power converter module 120 so that the power converter module 120 remains within a desired temperature range to maintain the efficiency of the power converter module 120. In some embodiments, the thermal management structure 220 is located at least partially within the housing 202 of the eye treatment device 200, along with the power supply module 110 and other internal components. In some embodiments, one or more of the following thermal management structures 220 are provided within housing 202: a heatsink (e.g., the finned heatsink embodiment of thermal management structure 220 shown in FIG. 8), a thermoelectric (Peltier) module (e.g., thermoelectric module 224 shown in Fig. 8), compact vapor compression module and fan. In some embodiments, thermal management structures 220 direct and distribute heat so that housing 202 remains cool to the touch.

[00172] Additionally, in some embodiments, the eye treatment device 200 includes a surface cooling system designed to prevent the surface of the eyelid from heating to the point of discomfort or injury while the target tissue beneath the surface is heated. A surface cooling system is not required in all embodiments; for example, in some embodiments, the selected energy converter module 120 is configured to emit light energy at a wavelength that is absorbed in a target tissue area within the eyelid or in an energy-absorbing portion of the scleral shield with minimal heating of the eyelid surface tissue. In embodiments in which a surface cooling system is present, the surface cooling system may be configured to cool the patient's eyelid surface to or below body temperature or to a temperature below the target tissue temperature or below a discomfort threshold before, during, or after energy is applied to the target area fabrics. The surface cooling system may comprise any suitable structure configured to cool the eyelid surface and/or cool the energy transfer surface 140. For example, in some embodiments, the surface cooling system includes an active cooling element, such as a fan. In some such embodiments, the energy transfer surface 140 is shaped such that an air gap exists between the energy transfer surface 140 and at least a portion of the eyelid. In fig. 2B shows an embodiment having a structure suitable for this purpose. In such embodiments, air may be blown through the air gap across the surface of the eyelid. In other embodiments, the energy transfer surface 140 may have one or more holes or channels extending through or along the energy transfer surface 140 through which air can be blown. In some embodiments, the eyelid is cooled before air blows over the surface of the eyelid. The air can be cooled, for example, using a thermoelectric cooler, compressor, ice, or other cooling element.

[00173] In other embodiments, a volatile substance, such as water or alcohol, may be applied to the energy transfer surface 140 such that the surface of the eyelid then comes into contact with the volatile substance. Additionally or alternatively, the vaporizable substance may be applied to the surface of the eyelid before, during, or immediately after treatment with the eye treatment device 200. As evaporation occurs on the surface of the eyelid due to the evaporating substance, the patient may experience a feeling of cooling and relief. In still other embodiments, the eye treatment device 200 may include a cooling elastic bag positioned between the energy transfer surface 140 and the surface of the eyelid. The elastic bag may be filled with cool water or gel and provide cooling and a feeling of relief to the patient when the elastic bag is in contact with the surface of the eyelid. As another non-limiting example, the surface cooling system may include the power transfer surface 140 itself. In some such embodiments, the energy transfer surface 140 may be made of an energy-absorbing material, such as, for example, diamond, sapphire, calcium fluoride, or graphene, and thermally coupled to greater thermal mass. Such large thermal masses take a long time to heat up and therefore cannot heat up significantly during the treatment period. Therefore, a large thermal mass can remove heat from the energy transfer surface 140 during the treatment period. In addition, the large thermal mass may be cooled before or during the treatment period, and may be made of the same materials as part of the energy transfer surface 140, or it may be made as a separate element from materials such as copper, aluminum, or other energy-absorbing or conductive material.

[00174] In addition to the thermal control structures 220 and surface cooling systems described above, at least some eye treatment devices 200 include one or more safety sensors 230, for example, to monitor parameters of the eye treatment device 200 or to ensure patient safety. . In fig. 10 shows one example of an eye treatment device 200 having one or more safety sensors 230. Any of the security sensors 230 and associated control devices 212 described with reference to FIG. 10 are expressly provided for use with any of the embodiments of the eye treatment device 200 described herein. Any particular eye treatment device 200 may include one or more types of safety sensors 230. The first set of security sensors 230 shown in FIG. 10, designed for temperature measurement. Such security sensors 230 include a non-contact temperature sensor 232 and a thermocouple or thermistor 234. The non-contact temperature sensor 232 may be a remote-reading IR thermometer (such as a thermopile, pyroelectric thermometer, or microbolometer) or other suitable non-contact sensor. The non-contact temperature sensor 232 may be designed to collect temperature data from the entire illumination field, for example, during a treatment period to monitor the surface temperature of one or more eyelids, or it may be designed to focus on a specific area and provide a temperature reading of that area . For example, the non-contact temperature sensor 232 may be positioned and adapted to provide a temperature reading of a portion of the cornea, sclera, or other area of the eye to ensure that such tissue is not overheated or damaged, as shown in FIG. 8, for example.

[00175] Additionally or alternatively, some embodiments include a thermocouple or thermistor 234 (or RTD) located on or adjacent to the power converter module 120. This arrangement allows the thermocouple or thermistor 234 to sense the temperature of the power converter module 120 so that the temperature of the power converter module 120 can be monitored. If power converter module 120 overheats, it may become ineffective and/or fail. Additionally or alternatively, a thermocouple or thermistor 234 may be located on or within or adjacent to the power transfer surface 140. This arrangement allows the thermocouple or thermistor 234 to sense the temperature of the energy transfer surface 140 and/or the eyelid surface. Monitoring the temperature of such surfaces may help ensure that the patient does not experience significant discomfort or injury from using the eye treatment device 200. In some embodiments, various temperature sensors 232, 234 are operably coupled to a control device 212, which may be programmed to modulate the output of the power converter module 120, or one or more thermal control structures, or surface cooling systems to provide or maintain a temperature within a preset range. specific target range. In addition, if the temperature input signals from the temperature sensors 232, 234 are above a predetermined range, the control device 212 may turn off the output signal of the power converter module 120. Additionally or alternatively, temperature sensors 232, 234 may be coupled to a scleral screen 300 (not shown in this figure) to monitor the temperature of the inner surface of the eyelid and/or the surface of the eye. Additionally, a pressure sensor or sensors 221 may be located on or within or adjacent to the scleral shield 300 and/or energy transfer surface 140 to monitor the pressure or force applied by the user to the eyelid.

[00176] The second set of security sensors 230 shown in FIG. 10 is provided for determining the position of the eye treatment device 200 relative to the eyelid of the patient. A light sensor 236 present in or on or adjacent to the power transmission surface 140 is configured to detect light. In various configurations of the eye treatment device 200, when the energy transfer surface 140 is properly positioned adjacent one or two eyelids, depending on the configuration, it should significantly reduce the amount of ambient light that can reach the light sensor 236. In some embodiments, if light is detected in or on or near the power transfer surface 140 above the threshold range, this indicates that the power transfer surface 140 is not positioned correctly. Likewise, contact sensors 238 may be present in or on the energy transfer surface 140. Each contact sensor 238 may be configured to detect changes in capacitance, such as, for example, a change in capacitance that occurs when contact sensor 238 is in proximity to human skin. Alternatively, contact sensors 238 may include electrodes that apply a small DC or AC microcurrent and detect impedance changes resulting from contact with the skin. Alternatively, contact sensors 238 may include microswitches or force or pressure sensors, each of which produces a change in signal characteristics when the energy transfer surface 140 contacts the skin. Thus, sensors 238 may be used to help determine the location of the eye treatment device 200. If the eye treatment device 200 is properly positioned against the closed eye, the upper contact sensor 238 and the lower contact sensor 238 should both come into contact with the skin of the eyelid and detect a change in capacitance (or impedance, switch state, force, pressure, etc.). In various embodiments, light sensor 236 and/or contact sensors 238 are operably coupled to control device 212. In some such embodiments, control device 212 is programmed to prevent activation of power converter module 120 until control device 212 detects, through signals from sensors 236, 238, that eye treatment device 200 is correctly positioned adjacent to the closed eye. Additionally, in some embodiments, control device 212 is programmed to turn off power converter module 120 if signals received from sensors 236, 238 indicate that eye treatment device 200 is no longer positioned correctly against the closed eye. Additionally or alternatively, thermocouples or thermistors 234 on or in or adjacent to the energy transfer surface may be used to indicate when the device is properly positioned adjacent to the patient's eye. For example, thermocouples or thermistors 234 may sense room temperature before placing the device adjacent to the eye, and when the energy transfer surface 140 comes into contact with the skin of the eyelid (in embodiments where direct contact is required), thermocouples or thermistors 234 will register a value closer to to body temperature, and therefore confirm correct placement. Additionally, if multiple thermocouples are used in embodiments in which both the upper and lower eyelids are treated, data from thermocouples or thermistors 234 can be used to determine whether the eye is open or closed. A reflective sensor or color sensor 237 may also be incorporated into the device for the purpose of confirming that the eye is closed. Such a sensor 237 may either detect the color of a region of the optical field in front of the sensor 237, or it may determine the degree of reflectance of a surface in front of the reflective sensor or color sensor 237. In either case, sensor 237 provides data indicating whether there is tissue that appears to be eyelid skin (eg, flesh-colored and not wet or shiny) or eye tissue (white or iris-colored, wet and shiny).

[00177] In some embodiments, contact sensor 238 includes a microswitch embedded behind a flexible sealed surface. In other embodiments, the contact sensor 238 includes a sensor that provides an indication of the amount of force or pressure applied by the energy transfer surface 140 to the eyelid. Such an indication may be useful to avoid applying excessive force during treatment or to apply force within a certain range during initial diagnosis when the eyelid is supposed to be slightly compressed so that meibomian gland secretion can be assessed. It will be appreciated that the force of the energy transfer surface 140 toward the eyelid or eyelids applied by the physician may or may not be adjustable. Additionally, in an ambulatory device, force may be applied with a rotational component or an angular component to promote movement of meibomian gland secretions out of the meibomian glands and ducts. In some embodiments, the energy transfer surface and/or scleral shield may have surfaces that are curved or angular in shape, or may have oscillating features such that when the energy transfer surface presses the eyelid against the shield, greater compression initially occurs in the lower meibomian gland region, which gradually progresses to to the upper region as compression increases, moving the meibomian gland secretion from the lower region to the upper region and then from the meibomian gland ducts.

[00178] FIGS. 11A and 11B show side views of additional embodiments of an eye treatment device 200 having an energy converter 205 configured to convert electrical energy from the power supply module 110 into ultrasonic energy. Ultrasonic energy transducer 205 may be made of any suitable material, such as piezoelectric ceramic, polymer, or composite. In various embodiments described above, ultrasonic energy converter 205 may be used in combination with light energy converter module 120.

[00179] In FIG. 11A, the eye treatment device 200 includes a planar piezo-ultrasound energy transducer 205 configured to emit unfocused ultrasonic waves. Although the direction of the waves is not focused, the wavelength of ultrasound energy can still be manipulated to target specific areas of tissue. When using ultrasonic energy, the longer the wavelength, the deeper the penetration. Accordingly, in some embodiments, short high frequency waves of 20-100 MHz, 50-100 MHz, or any sub-bands or individual values in between are emitted. Ultrasound waves of such frequencies can penetrate the tissue of the eyelid by 1-3 mm. Advantageously, at these penetration depths, the meibomian glands and other surrounding target tissue can be heated without significant heating within the eye. In other embodiments, the ultrasonic energy transducer 205 may emit a wavelength greater than 100 MHz.

[00180] The eye treatment device 200 shown in FIG. 11B includes one or more curved piezo-ultrasonic energy transducers 205 configured to produce focused ultrasonic waves. In some embodiments, the ultrasonic waves are directionally focused to selectively heat the target tissue area sufficiently to melt meibomian gland secretions in meibomian glands located within or adjacent to the target tissue area. In some such embodiments, ultrasonic waves are aimed and directed through the use of a specially shaped or curved transducer having a focal point. In fig. 11B depicts one such embodiment. In other embodiments, ultrasonic waves are targeted and directed using a shaped array of individual ultrasonic elements. There may be more than one array of ultrasonic elements; for example, one array may be directed to the lower eyelid and another array may be directed to the upper eyelid. It will be understood that in order to effectively transmit ultrasonic energy into the target tissue, the energy transfer surface 140 must be made of a suitable material. For low frequency ultrasonic waves, traditional materials such as silicone or other polymers and elastomers can be used. In some embodiments, it may be desirable to cool the eyelid surface upon application of ultrasonic energy to prevent exceeding a predetermined threshold. In such cases, the energy transfer surface 140 may be made of a material that not only can transmit ultrasonic energy, but which is also thermally conductive (so that the cooling techniques described earlier herein can be used). Examples of materials that can transmit higher frequency ultrasonic energy while also providing adequate thermal conductivity include diamond or graphene.

[00181] It will be understood that, in addition to providing tissue heating effects, ultrasonic waves can disturb, destroy or even kill the Demodex mites mentioned earlier. As such, it may be beneficial to combine energies such as light and ultrasound to achieve the best overall treatment for MGD, blepharitis and related conditions.

[00182] In addition to heating the target tissue area, the eye treatment device 200, in certain embodiments, may also be configured to send vibrational energy to a zone that includes the target tissue area. In fig. 12 illustrates one example of an eye treatment device 200 configured to generate vibrational energy. Embodiments of the vibration mechanism 250 described with reference to FIGS. 12 are expressly provided for use with any of the embodiments of the eye treatment device 200 described herein. The eye treatment device 200 shown in FIG. 12 includes a vibration mechanism 250 within a portion of the housing 202. Any suitable vibration mechanism 250 may be used. In various embodiments, the vibration mechanism 250 is configured to generate vibrations in a specific pattern. For example, when applied to a patient's eyelid, the eye treatment device 200 having a vibration mechanism 250 may vibrate back and forth along an axis parallel to the central ocular axis 30. In other embodiments, the eye treatment device 200 may vibrate side to side or upward and downward in directions perpendicular to the central ocular axis 30. In yet other embodiments, the eye treatment device 200 may vibrate in a circular pattern, such as in a circular pattern perpendicular to the central ocular axis 30. In some embodiments, the eye treatment device 200 may have multiple settings so that you can select a variety of vibration patterns. The vibration pattern can be applied to the eyelid before, during, or after heat is applied to the targeted tissue area.

[00183] In some embodiments, the vibration frequency is from about 1 Hz to about 20 kHz, but may be in the ultrasonic frequency range up to 20 MHz and may include any subrange or individual value in between. Vibrations within the frequency range can help in squeezing out meibomian gland secretions that have become thickened or blocked within the meibomian glands. Additionally, the vibration pattern may disturb or disrupt Demodex mites, thereby reducing their spread. It will be appreciated that combinations of vibration and/or ultrasonic energy can be used to create the most effective overall treatment involving heating of meibomian gland tissue and secretions, vibration and squeezing of meibomian gland secretions, and destruction of mites.

[00184] As further shown in FIG. 12, in some embodiments, the vibration mechanism 250 is located in the distal portion 203 of the housing 202. In some such embodiments, the vibration isolating element 252 is located between the distal portion 203 of the housing 202 and the proximal portion 201 of the housing 202 such that the vibration force is damped in the proximal portion 201. In some embodiments, a handle or hand grip portion of the eye treatment device 200 is located in the proximal portion 201; thus, the anti-vibration element 252 helps limit vibrations of the user's hand during use. In other embodiments, the insulating element 252 is omitted. In still other embodiments, the vibration mechanism 250 is located within the proximal portion 201 of the housing 202 with a transmission element between the vibration mechanism 250 and the distal portion 203.

[00185] It should be emphasized that the above specific embodiments are illustrative and that this invention covers a large number of variations beyond these specific embodiments. Some of them will now be described in more detail.

[00186] When the power converter module 120 is an LED emitter 207, some embodiments include the use of one or more LEDs, preferably having high intensity. For example, one or more LEDs having a total power output of at least 10 watts, preferably at least about 15 watts, or even 20 watts or more of total power output. The combined intensity of these LEDs may advantageously be at least about 20, 30, 40, 50, 75, 100, 150, 200, 250, 300, 400, 500, 1000, 2000 or more lumens. When directed into the eyelid, the continuous intensity of the applied light energy may preferably be from about 0.02 to 2 watts/square centimeter.

[00187] In some embodiments, the LEDs may be green LEDs. The advantage of green is that it penetrates the tissue and heats it to a depth of approximately 0.5-2 mm, beyond which it weakens significantly. This allows light energy to penetrate into the treated area, covering tissue on or adjacent to the meibomian glands, while limiting the light transmitted to the eye. Some preferred light wavelengths may be 495-570 nm, 500-600 nm, and more preferably about 510-540 nm or 520-530 nm. In some embodiments, the infrared radiation source may represent 700-1000 nm, preferably in the human tissue optical window of approximately 800-900 nm, and more preferably approximately 850 nm. Longer wavelengths will also work, potentially having the benefit of greater water absorption in tissue as wavelength increases. For example, 3000 nm infrared radiation can provide ideal heating of eyelid tissue with minimal penetration and heating of the eyeball and sensitive structures. In other embodiments, the LEDs may be blue, yellow, red, white, or a combination of any of the above.

[00188] Power converter module 120 may alternatively include a broad spectrum or narrow spectrum lamp, such as an incandescent lamp, xenon lamp, halogen lamp, cold cathode tube, fluorescent tube, etc. The light source may further include a spectrum limiting element to reduce intensity or substantially eliminating certain undesirable wavelengths from the lamp's spectrum. These spectrum limiting elements may include color filters, dichroic filters, IR cut filters, gratings, bandpass filters, spectrum separation elements such as prisms or gratings, and the like. You can also use infrared lamps or heating elements. The main wavelengths allowed to reach the century can be chosen as described above for LEDs, or can be limited primarily to infrared radiation.

[00189] The energy emitted by the light source and delivered to the patient is preferably continuous upon delivery (pulse-width modulated or otherwise modulated as necessary), as opposed to high-intensity, low-duty-cycle pulsed light (such as IPL). The treatment period is preferably several seconds or minutes, for example 5, 7, 10, 12, 15, 18, 20, 15, 30, 40, 45, 50, 60 seconds or 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 20 or even 30 minutes or more.

[00190] In some embodiments, the supply of visible light from the power converter module 120 may be facilitated or replaced by an alternative power converter functioning as a heating means. These may include, for example, an ultrasonic transducer or a radio frequency emitter. When an ultrasonic transducer is used, it can be either focused or unfocused. High frequencies are preferred to limit the depth of heating, concentrate the heat on a target area of tissue containing or adjacent to the meibomian gland, and to reduce or eliminate effects on the eyeball or other tissue in that area. Preferred frequencies are 50-100 MHz or greater than 100 MHz-250 MHz. Focused ultrasound, for example using multiple transducers, including phase controlled gratings to facilitate directional focusing, or specially shaped transducers having a limited focal area, are particularly preferred. As with light energy, a relatively continuous supply can be used, as can a pulsed supply.

[00191] When a radio frequency emitter is used, frequencies known to produce local heating are preferred. Frequencies used for electrosurgery, such as 300 kHz-4 MHz, can be advantageously used. In one such embodiment, bipolar electrodes are provided in or on the energy transfer surface 140 to contact the eyelid and allow control of the location and depth of heating.

[00192] Alternatively, higher frequency radio waves in the range of 5 MHz to 10 MHz may be used due to their higher tissue attenuation rate, allowing for careful selection of penetration depth and limiting heating to the desired tissue area. For example, frequencies above approximately 245 MHz penetrate human skin and tissue to a depth of approximately 1-3 mm, which corresponds to the typical distance between the outside of the eyelid and the target tissue (ie, meibomian glands and adjacent tissue).

[00193] The energy waveguide module 130 is configured to transfer energy from the transducer or generator to the energy transfer surface 140 and from there to the target tissue. For example, when generating light energy from a small source, such as an LED or small lamp, energy waveguide module 130 can direct uniform illumination from the source to target areas of tissue. In some embodiments, it may be desirable to include a waveguide structure to direct light to the eyelid and target tissue without directing it along the central ocular axis of the eye. This can then reduce the amount of light entering the cornea and into the eye, while still directing light into the eyelid, albeit at a more direct angle. Suitable structures for achieving this goal include light guide arrays, refractive elements, reflective elements, diffractive elements, total internal reflection (TIR) elements, and diffusers. For example, fiber optics, mirrors, lenses, prisms, etc. can be used to direct light and change its angle of incidence on the target surface (for example, to avoid the central ocular axis). In some embodiments, it may be desirable to direct light to the scleral screen 300 and image transducer 155 to view the inside of the eyelid 14 and/or heat the meibomian glands behind the eyelid, as described above.

[00194] In another embodiment, energy waveguide module 130 is an ultrasonic waveguide having surfaces that reflect ultrasonic energy to direct and/or focus it to a desired area, such as a target tissue area. Likewise, a microwave or other radio frequency waveguide of known design can be used to direct radio frequency energy to the desired area.

[00195] The energy transfer surface 140 is located between the interior of the eye treatment device 200 and the patient, providing a barrier between them. In some embodiments, this may be provided as a window through which energy is delivered to the patient. It can be adapted to be in direct contact with the patient's eyelid or positioned at a short distance from the eyelid, for example 0.5 to 12 mm from the eyelid, during treatment. Preferably, the outer surface of the power transmission surface is smooth and easy to clean. In some embodiments, a disposable outer eyelid pad 147 may be placed over the energy transfer surface 140 to prevent cross-contamination between patients. The outer eyelid liner 147 may be made of any suitable material such as glass, pyrex, quartz, mica, or polymers such as polycarbonate or other optically clear materials, or a combination thereof, may be used to achieve the desired structural and optical properties. properties. In some embodiments, the energy transfer surface 140 may be configured to be relatively movable along a movement path 145 relative to either the energy transducer module 120, the scleral shield 300, or the housing 202 to allow the energy transfer surface 140 to be pressed against the eyelid or eyelids so that : a) minimize photon energy leakage during treatment and imaging and b) apply compressive force to the eyelid when necessary during assessment or extrusion of meibomian glands.

[00196] When using light energy to heat a target area of tissue, the energy transfer surface 140 is advantageously transparent to visible or infrared light, as desired. In some embodiments, it is transparent to the peak or desired wavelengths used for treatment, such as visible light or green light, but blocks infrared light, thereby reducing IR heating of the eyelid. Glass, Pyrex, quartz, mica or polymers such as polycarbonate or other optically transparent materials can be used.

[00197] When heating a target area of tissue using ultrasound or RF, transparency to visible light is not required; instead, a material that is ultrasonic transparent or RF transparent can be used. In some embodiments, it is desirable for the materials to be thermally conductive to facilitate cooling of the eyelid by cooling the energy transfer surface 140. Diamond, sapphire and graphene are suitable thermal conductive materials. In another embodiment, either the entire power transmission surface 140, or at least a window thereof, is transparent to the security sensors described herein. For example, when a non-contact infrared temperature sensor is used to measure the temperature of the outer eyelid, an infrared transmitting material is advantageously used for the entire or at least the corresponding area or areas of the energy transfer surface 140.

[00198] When thermal energy is applied to the eyelid from the eye treatment device 200, some embodiments include superficial cooling of the eyelid by cooling the energy transfer surface 140. If the outer portion of the eyelid is cooled while irradiating the target tissue area with light, ultrasound, or RF energy, patient comfort can be enhanced while maximizing efficiency through optimal heating of the target tissue. The power transfer surface 140 may be cooled by: air flowing through the interior of the power transfer surface 140; applying a vaporizable substance to the interior of the energy transfer surface 140, such as refrigerant or water; circulating a cooling fluid through channels within or on the power transfer surface 140; or contact of the energy transfer surface with a thermoelectric element (Peltier junction) or a heat sink associated with the cooling means. Alternatively, the energy transfer surface 140 may have a sufficiently large thermal mass (or be in contact with such thermal mass) to conduct sufficient heat away from the eyelid during treatment of a patient to maintain the eyelid within a desired temperature range. The thermal mass can be pre-cooled or simply started at ambient temperature before treatment. Other methods of cooling the energy transfer surface 140 and/or the eyelid include incorporating a reservoir between the energy transfer surface and the skin of the eyelid, such as an elastic bag filled with water. The elastic bag may be pre-cooled or may be actively cooled during the procedure, for example by circulating cold water through it or by using a cooling element such as a thermoelectric device, compressor, refrigerant or other cooling element.

[00199] In another embodiment, the energy transfer surface 140 is located at a short distance from the eyelid to allow the passage of a cooling fluid, such as relatively cold air, mist, water, etc., between the energy transfer surface 140 and the eyelid. For example, cool air may be caused to flow laterally across the eyelid surface and the energy transfer surface 140, or the energy transfer surface 140 may include holes or channels to direct cooling fluid to the eyelid. The cooling fluid may be at ambient temperature or may be pre-cooled, such as by refrigeration, ice, or the like.

[00200] When the vibration mechanism 250 is used, it may include, for example, a reciprocating element such as an electromechanical solenoid or the like, a rotating eccentric weight such as an eccentric weight coupled to a motor shaft, or a rotating cam. Preferably, the vibration mechanism is oscillatingly coupled to the eyelid, but oscillatingly isolated from other points of contact with the patient or clinician, such as the proximal end of the eye treatment device 200, including any handle area that the patient or clinician may hold.

[00201] Patient safety and comfort are important factors in the present device and method. Therefore, safety and warning sensors can advantageously be integrated into the device. These include sensors to prevent overheating of the skin, sensors to prevent unwanted activation of the device, and sensors to monitor energy delivery to the patient. In some embodiments, a safety sensor may be used to ensure that the consumable portion 260 having the protective scleral shield 300 is in the correct position before turning on the power converter module 120, thereby preventing damage to the eye system 10.

[00202] As shown in FIG. 10, a caution warning device 240 may be included in the device to notify the patient of an unsafe condition detected by any of the sensors described herein. It may include a flashing light, a flashing warning, an audible warning tone, a picture, a vibration pattern, or words indicating the possibility or presence of an unsafe condition.

[00203] Referring again to FIG. 10, the first set of security sensors 232, 234 are preferably located on, within, behind, or otherwise adjacent to the power transmission surface 140. Both sensors are designed to detect heating of the outer surface of the eyelid and prevent it from overheating. Sensor 232 is preferably a non-contact sensor, such as a pyroelectric sensor (such as an IRA-E700ST0 from Murata), or a thermopile (such as an ST25T0-18 from Dexter Research, Dexter, Mich.), or a conventional temperature monitoring device, such as a thermocouple, thermistor, fiber optic temperature sensor, or digital temperature sensor (such as the Dallas Semiconductor DS-18620). In addition to temperature sensors 232 and 234, temperature sensors 310 may be mounted on the front or rear surfaces of the scleral shield 300, as shown in FIG. 3, 7A-H and 8, for monitoring the temperature of the inner surface of the eyelid and the temperature of the eyeball, respectively. The eye treatment device 200 may be programmed with a threshold temperature, such as 40°C, 45°C, or 50°C. In some embodiments, when a threshold temperature is reached or exceeded, the safety sensor may be configured to disable the eye treatment device 200 and/or, through the caution warning device 240, to signal the user or physician to discontinue treatment through lights, sounds, or other notification means. In some embodiments, when a threshold temperature is reached or exceeded at any particular location, control device 212 (or discrete circuitry independent of any control device) may be used to prevent the eyelid from heating above that threshold temperature. This may be achieved, for example, by turning off the eye treatment device 200, reducing the energy delivered (e.g., reducing light intensity, pulse width modulation of LEDs, reducing power consumption for ultrasonic or RF energy, etc.), or activating cooling means to reduce century temperatures.

[00204] A second type of safety sensor is also shown in FIG. 10. This may be one sensor or several sensors. The purpose of the second type of safety sensor is to ensure that the eye treatment device 200 is positioned correctly against the eyelid before treatment begins. The second type of security sensor may include one or more of the following sensors. One sensor may be a light sensor 236 . When the device is placed against the eyelid, light from the external environment is blocked. In this way, the absence of such light can be detected. Alternatively, an optocoupler-type reflective device may be used, in which the light source is directed distally and coupled to a sensor also aimed distally. This allows the presence of a patient to be detected, as well as the approximate distance to the patient. Depending on the distance between the light source and the optocoupler type device, light detection is either maximized or eliminated when the eye treatment device 200 is installed correctly. Another light detection scheme is to provide a light sensor 236 facing distal to the patient but outside the path of the treatment light. When the eye treatment device 200 is positioned away from the eyelid, the reflected treatment light may reach the sensor 236, but when properly positioned, most of such light is blocked from the sensor 236. A light sensor approach can couple data from one of the temperature sensors to simultaneously detecting light and skin temperature as an indication of device location. In any of the light sensing embodiments, an environmental light sensor 236 may be incorporated into the eye treatment device 200 to measure environmental light levels to facilitate optical detection of proximity to the eyelid. Likewise, when using a temperature sensor in combination with a second type of sensor, the ambient light sensor 236 may facilitate detection of when the eye treatment device 200 is in contact with the skin, particularly under high temperature conditions. Other distance or contact detection elements, such as an ultrasonic rangefinder, may also be used. In some embodiments, thermocouples or thermistors 234 on or in or adjacent to the energy transfer surface may be used to indicate when the device is properly positioned adjacent to the patient's eye. For example, thermocouples or thermistors 234 may sense room temperature before placing the device adjacent to the eye, and when the energy transfer surface 140 comes close to the skin of the eyelid, the thermocouples or thermistors 234 will register a value closer to body temperature and therefore confirm proper placement. A reflective or color sensor 237 may also be incorporated into the device to confirm that the eye is closed. As described above, such sensors 237 may provide data indicating whether there is tissue that appears to be eyelid skin (eg, flesh-colored and not wet or shiny) or eye tissue (white or iris-colored, wet and shiny).

[00205] In another embodiment, the second type of sensor may be a tactile sensor that detects when the eye treatment device 200 touches the face. The tactile sensor may be a resistive sensor using two electrodes and sensing microcurrent through the skin, or a conventional resistive tactile sensor. Alternatively, a capacitive sensor may be used to detect when the eye treatment device 200 contacts the skin. This can be either a single sensor or, for a better signal, multiple sensors, all or some of which must be activated to allow treatment to continue. Finally, the tactile sensor may include an electrical switch (such as a microswitch) or a strain gauge that is activated when the device is pressed against the skin. For example, the microswitch may be embedded behind a flexible sealed surface, or it may be activated by applying pressure sufficient to cause the first portion of the eye treatment device 200 to move relative to the second portion of the eye treatment device 200.

[00206] The eye treatment device 200 may also utilize a third type of safety sensor to monitor the power supply converters to ensure proper operation within specified parameters. Again, this may be a single sensor or a combination of sensors containing one or more of the following sensors. In some embodiments, the safety sensor may measure the current and/or voltage supplied to the converter, as shown in FIG. 10 as a 246 converter monitor. Thus, when the transducer is one or more LED emitters 207, drive current or forward voltage of the LEDs can be monitored, where deviation from preset parameters may indicate LED or LED driver failure or unsafe operating conditions. The voltage across the RF or ultrasonic transducer can similarly be monitored by the transducer monitor 246, as can the current supplied to it. In another embodiment, a thermal sensor, such as a thermocouple or thermistor 234, shown adjacent to power converter module 120 in FIG. 10 may be configured to monitor the internal or external temperature of the converter element, where overheating may indicate unsafe operation or failure of the element, and lack of heating may also indicate malfunction.

[00207] In some embodiments, control device 212 may be a manually controlled system, or an open-loop system, with self-contained discrete analog and digital circuitry for manual control without any automatic control. Manual operation may include turning the eye treatment device 200 on and off and receiving safety information and feedback information. In this case, the eye treatment device 200 is operated manually without a control device by the user or by a clinician who turns on the eye treatment device 200 and evaluates the required eyelid treatment through feedback and process control in response to this assessment. Feedback elements may provide status signals to the user or clinician, such as on/off, light or sound signals, temperature data, pressure data, safety data, or other data that may help the user or clinician evaluate the process. In some embodiments, the safety control device 212 may include direct threshold detectors and shutdown circuits. In some embodiments, the control device 212 may include a processor or centralized controller configured to monitor the process through feedback elements, and some of the feedback is returned to the control device to provide safety, such as shutting down the system in an unsafe state.

[00208] The control device 212 functional block encompasses and performs both operational functions to direct the intended operation and safety functions to interact with various security sensors 230. It may be a single processor that controls all functions, that is, a single control device 212, as shown in FIG. 3 and 4A, or may comprise two or more control devices, such as a main control device with a secondary safety controller acting as a watchdog on the first control device, as is well known to those skilled in the art. In particular, the auxiliary safety controller may be configured to monitor the functionality of the main control device: if one or more parameters indicate that the main control device 212 may not be functioning correctly, the auxiliary safety controller is adapted to turn off power to the power converter and/or the entire device 200 for eye treatment. The functions associated with control device 212 may be performed by a control device such as a microprocessor or microcontroller with associated software, but some embodiments may preferably operate without a control device and instead use one or more of a programmable gate array, logic matrix, analog circuit, digital circuit elements, or any combination of the above.

[00209] In one simple embodiment, the auxiliary security controller comprises an array of analog or digital circuit elements without a processor. For example, optical relays, temperature and/or pressure relays connected together by wires or logic, operational amplifiers and/or relays are adapted to allow initial or continued operation of the device only if the sensors are in a predetermined state. In an alternative embodiment illustrating full processor control, all sensors are monitored via digital or ADC inputs to one or more programmable processors to perform the functions of a second safety controller and either prevent operation outside predefined parameters or modulate the operation of active elements in the device 200 for treating the eye so that they remain within these parameters.

[00210] In addition to the safety functions, the control device 212 may direct the normal operation of the eye treatment device 200. For example, it may interact with the user through a user interface 270, which may include control buttons, rotary encoders, touch screens, voice commands, or any other traditional user interface. It can control a power regulator, direct or interrupt current flow to a power converter and modulate its output, start or stop a vibration device, initiate or disable a caution warning, initiate, modulate or stop a surface cooling device, and monitor and modulate cooling energy converter using a temperature controller. A control device 212, or equivalent in the form of a discrete component circuit, may be operatively coupled to some or all of these systems in the eye treatment device 200. In addition, it may include a timer function to automatically turn off the energy converter and thereby interrupt the delivery of thermal or vibration energy to the eyelid after a predetermined period of operation or in response to signals from safety sensors of the first, second or third type.

[00211] The power supply module 110 is configured to facilitate power supply to the eye treatment device 200 . It may include external power interfaces, such as cords or cables that connect to an external power source. In a preferred embodiment, the power manager includes an internal power supply. In some embodiments, the power manager includes a rechargeable battery or battery pack. These may be nickel metal hydride batteries, lithium ion or lithium polymer batteries, nickel cadmium batteries, or any other suitable rechargeable or non-rechargeable battery. The batteries preferably provide a high current carrying capacity, such as 1-5 amps, preferably at least 3 amps overcurrent, with the ability to supply such high current for 1, 2, 3, 4, 5 or more minutes. In some embodiments, the internal batteries provide 3, 4, 5, 6, 7, 8, 9, 10, or 12 volts or more. The capacity of the batteries is determined by the design load and may be, for example, a battery pack having a capacity of at least 200, 300, 400, 500, 1000, 2000, 2500 mAh or more. The required voltage can be achieved by connecting lower voltage batteries in series to achieve the required voltage, or by using a DC/DC converter to step up the lower voltage to the required voltage. In some embodiments, the batteries supply a voltage lower than required by the power converter power supply, and the power converter is raised in voltage while a lower voltage, such as 5 V or 3.3 V, is supplied to control device 212 or an alternative discrete diagram.

[00212] In one preferred embodiment, the power converter may be a high power LED, such as those manufactured by LED Engin, Inc.; specifically, the power converter could be an LZ9 configured with nine green emitters in a custom configuration arranged as three sets of three emitters in series in parallel, requiring approximately 12-14V forward voltage and up to 2.4A for maximum illumination . In this embodiment, three RCR123 LiFePO4 or similar cells can be used in series, having a capacity of 750 mAh and providing an initial voltage of 7.2 V. A DC-DC converter circuit is available that approximately doubles the voltage to provide the voltage required to drive the LED.

[00213] Power management functions may include a charger, a battery health monitor, and/or a temperature monitor. These functions may be performed by separate circuits or included in whole or in part within control device 212. In some embodiments, the power control includes a battery charger powered by an external power source via an inductive coupling, which allows the eye treatment device 200 to be sealed for easy cleaning and to prevent moisture or dirt from entering. In some embodiments, the inductive connection may utilize a charging cradle or an electrically isolated electrical connection. An induction coupling may involve two induction coils in close proximity (one in the stand and one in the device) or two coils tuned to resonate at the same frequency (resonant induction coupling or electrodynamic induction).

[00214] Temperature control is also a critical element of many preferred embodiments, including, in some cases, dissipating heat from a power converter such as an LED or array of LEDs. In the case of LEDs, it is important to keep the junction temperature below a predefined threshold, such as 135 degrees Celsius. Other drives similarly have maximum component temperature limits, and proper temperature control helps keep those components within acceptable temperatures. For example, heat sinks thermally coupled to power converter elements, fans, radiators, cooling fluids, and the like may be used. In a preferred embodiment, the eye treatment device 200 is sealed and a thermal control structure 220 such as shown in FIG. 9 directs excess heat to the outer surface of the eye treatment device 200. This provides a sealed device without vents. In other embodiments, cooling fluid is directed from a temperature controller within the device to remove heat from the device, such as through forced air cooling (as shown in FIG. 8) or a liquid-cooled radiator.

[00215] In an additional aspect of the present technology, the eye treatment device 200 may include elements used to calibrate the device to provide the desired degree of heating to the target tissue over a wide range of eyelid thicknesses. This is important because without such calibration, the amount of heating that occurs in the target tissue area (eg, meibomian glands and adjacent tissues) may vary unless the temperature near the target tissue area is measured during treatment. As discussed previously, monitoring of the target tissue area can be accomplished using a scleral screen or similar device equipped with temperature sensors. However, device users may find it inconvenient to insert scleral shields each time they use the device. Therefore, it may be useful to calibrate each device according to the individual's anatomy. To do this, the device can first be calibrated using a scleral screen, preferably in the ophthalmologist's office, and in combination with an external monitor and calibrator.

[00216] For example, with reference to FIG. 13, when the eye treatment device 200 applies energy to the eyelid(s), the scleral screen 300 transmits temperature data (via a wired or wireless connection) to an external monitor and calibrator 500. The external monitor and calibrator 500 monitor the rate of temperature increase over time and thus characterizing the heating profile of the patient's eyelid(s). Using this data, the external monitor and calibrator 500 can then program the eye treatment device 200 to heat the target tissue to the desired temperature range. In a simple embodiment, the external monitor and calibrator 500 turns on the energy converter, measures the amount of time required to reach the desired target tissue temperature, and then turns off the energy converter and programs the eye treatment device 200 to deliver energy for the same amount of time. Alternatively, the eye treatment device 200 may be programmed to provide an increased or decreased amount of energy to heat the target tissue to a desired temperature for a preferred period of time. For most people, eyelid thickness is the same from upper eyelid to lower eyelid and from right eye to left eye, however it will be understood that an external monitor and calibrator can separately measure and separately program the device to apply a specific amount of energy to each person's eyelid to ensure each is heated correctly century. It will also be understood that there may be differences in the characteristics of the components used to implement the power converter and associated circuitry, and that without proper calibration, one device may produce more or less power than another. One solution to this problem is to measure at the factory the actual energy output for a given command level from the control device and include a calibration table in the control device so that each eye treatment device 200 outputs an equal amount of energy for a given command level. Alternatively and additionally, with the help of an external monitor and calibrator 500, such deviations can also be compensated for using the procedure described above, in which the ultimate goal of the eye treatment device 200 is to heat the target tissue to the desired temperature and each eye treatment device 200 is programmed to do so (independently from differences in components) for each specific patient (and not necessarily for each specific eyelid).

[00217] Referring now to FIG. 14A and 14B, in one embodiment of the scleral screen 300 there is an array of temperature sensors 310 built into the screen. For this application, where the screen is not actually used to protect the eye from energy but to measure temperature, the screen 300 may be made of materials that are substantially transparent to the energy emitted from the energy converter. As a specific example, if the power converter is a light source, the screen 300 may be made of a transparent material that transmits the wavelength(s) of light emitted by the power converter. Preferably, the screen 300 should also be as thin and flexible as possible, without sharp elements, so that it can be placed comfortably under the eyelids with minimal discomfort to the patient and so that it has minimal effect on tissue heating. In the embodiments shown in FIGS. 14A and 14B, an example is shown in which there is an array of six temperature sensors 310 on the front surface 302 of the screen 300 and a sensor array on the rear surface 304. This configuration allows the forward-facing sensors 312 to more directly measure tissue temperature on the inner surface of the eyelids, where meibomian glands are located, while rear-facing sensors 314 more directly measure ocular surface temperature along the midline of the central ocular axis, where the most sensitive tissues of the eye are nominally located. The temperature sensors may be discrete elements (eg, very fine wire thermocouples or miniature thermistors) embedded in the shield 300, or they may be thermocouples made by depositing thin films of appropriate metals onto the interlayers of the shield 300. In some embodiments, it is preferred The types of materials for the screen 300 are soft, flexible, biocompatible materials such as silicone, polyurethane, and various hydrogels like those used in contact lenses.

[00218] While the above embodiments describe a configuration having an external monitor and calibrator 500, it will be understood that the eye treatment device 200 itself may have the same built-in functionality, in which case the scleral screen 300 transmits temperature data directly to the device 200 to treat an eye, and the eye treatment device 200 programs itself to provide the appropriate treatment profile for that particular patient (and optionally for individual eyes and eyelids). In such embodiments, the eye treatment device 200 has a sophisticated user interface 270 allowing the clinician to instruct the eye treatment device 200 to perform a calibration sequence and optionally instruct the eye treatment device 200 which eye and/or eyelid is being calibrated. It is understood that if the eye treatment device 200 is calibrated to provide individually calibrated treatment for each eye or eyelid, the eye treatment device 200 must be able to indicate (via a series of light signals or an alphanumeric or graphical display) to the patient which eye or eyelid will continue to be treated.

[00219] Alternatively or additionally, a calibration element may be used to measure the energy output of the eye treatment device 200. For embodiments in which the energy converter is a light source, the calibration element may be a lux meter for measuring, for example, luminous flux, lumens, or radiant flux. For embodiments in which the energy source is an ultrasonic transducer, the calibration element may be an ultrasonic energy meter. The calibration element may be used to determine whether the eye treatment device 200 is operating within acceptable limits or not, and may also provide data to allow adjustment of certain parameters (for example, energy level or treatment time) to return the eye treatment device 200 to a desired setting. working range. It will be appreciated that the calibration element may also communicate directly with the eye treatment device 200 or indirectly (e.g., via a PC) with the eye treatment device 200 to reprogram the eye treatment device 200 with updated calibration data to maintain device operation within acceptable operating limits. range.

[00220] In some embodiments, the eye treatment device 200 may, for an ambulatory device, further include a temperature display element or dashboard 218, which may include temperatures of the inner surface of the eyelid and the outer surface of the eyelid. The temperature display element can display absolute temperatures or simply relative temperatures compared to a maximum. For example, temperatures may be displayed in a bar graph format or using one or more indicator lights.

[00221] In some embodiments, the eye treatment device 200 may further include a data logger 214 configured to record aspects of the treatment (e.g., time, date, usage parameters, temperatures, photographs, videos, etc.). In some embodiments, the eye treatment device 200 may further include a voice recorder 213 so that clinicians can record verbal observations about how healthy, clogged, atrophied, etc. the breasts are, along with the time, date, and name of the patient. This allows the clinician to perform the procedure without having to take manual notes and/or without the need for an assistant. In some embodiments, the eye treatment device 200 may further include communications capabilities configured to connect to an external PC, tablet, or smartphone to download data, voice recordings, camera images, or video clips.

[00222] In FIG. 15A-15D show another embodiment of an eye treatment device 200 positioned relative to the eyeball 20 for treating eyelid 14 for MGD, blepharitis and other diseases. In some embodiments, the eye treatment device 200 is configured to heat the inner and/or outer surfaces of the eyelid while compressing the eyelid, similar to the embodiment shown in FIG. 3A. As heat is transferred from the eye treatment device 200 to the eye system 10, particularly to the tissue being treated, such as the meibomian glands 18, the heat may soften the meibomian gland secretions and thus allow the meibomian gland secretions to be more easily squeezed out during eye massage or exercises. . The eye treatment device 200 may include the module configurations shown in FIG. 2A-2H and figs. 3A, along with additional components used in the operation of the eye treatment device 200.

[00223] The eye treatment device 200 may include a housing 202 having a proximal portion 201 and a distal portion 203 connected to a removable or consumable portion 260. The housing 202 may include a power supply module 110, a control device 212, a power converter module 120, and a surface 140 energy transfer. The power converter module 120, in some embodiments, may include an LED device formed by one or more of an LED emitter 207, a thermal control structure 220, and a power converter module driver 209. The power transfer surface 140 and the LED emitter 207 are located adjacent the distal portion 203 of the housing 202 and are configured to be relatively movable along a movement path 145 relative to the power converter module 120 by an actuator 182 that allows the power transfer surface 140 to move simultaneously with the LED emitter 207.

[00224] The housing 202 may further include visualization tools 160 for improved monitoring of the eyelid margin during diagnosis and treatment, a display or instrument panel 218 showing various eyelid temperatures, such as inner and/or outer surface temperatures, a data logger 214 and/or or a voice recorder 213 and circuitry for communicating between the device and the consumable circuitry to identify the type of consumable, ensure that the consumable is in proper alignment, and/or prevent reuse of the consumable.

[00225] The consumable portion 260 may include a scleral shield 300, as disclosed above, which may be positioned between the eyelid 12, 14 and the eyeball 20 to cover the sensitive structure of the eye system 10 (such as shown in FIG. 1). The scleral shield 300 may be coupled to the housing 202 by one or more brackets 262, with wires located on or within the brackets, and in certain embodiments, the structural portion of the brackets 262 is made of insulating materials surrounding or otherwise guiding conductive portions of the wire or set of 420 wires.

[00226] The eye treatment device 200 may include a power supply module 110 for providing power to various components of the eye treatment device 200 and may be electrically coupled to some or all of the components. In some embodiments containing a control device 212, the control device 212 may receive input commands from a user (e.g., through a user interface device 270 such as a button, switch, touch screen, voice commands, from another module or device such as a smartphone) for emitting light from the LED emitter 207.

[00227] The LED emitter 207 forms part of one type of power converter module 120 that may be configured to emit light of the appropriate wavelength needed for the desired treatment. Treatment may include one or more of the following: diagnosing the eyelids 12, 14 by illuminating the inner and/or outer surfaces, eyelid margins, and/or meibomian glands behind the eyelids; heating the target tissue area of the eye system 10 (for example, the meibomian glands behind the eyelids 12, 14); and antibacterial treatment to kill bacteria in the eye system 10.

[00228] In some embodiments, an additional shielding element 258 may be used to prevent unwanted photon energy (such as IR or blue/violet light) from being reflected from the transilluminated element back to the clinician.

[00229] A feature of many embodiments disclosed herein is the ability for the clinician to examine the eyelid margin while applying heat and compression. By examining the margin, the clinician can see what contents, if any, are being released from the meibomian ducts and thereby adjust the amount of heat and compression applied to the eyelid being treated to optimally clear the blocked meibomian glands. For example, at the beginning of treatment, the clinician may observe that certain meibomian glands in part of the eyelid being treated have a clear oily discharge that signals normal glands. In contrast, some glands may secrete a cloudy, oily secretion or small amounts of thick, toothpaste-like lipids, both of which signal gland dysfunction. When the doctor applies heat and compression to the portion of the eyelid being treated, further observation of the dysfunctional glands may reveal that cloudy or thick discharge becomes clear and the amount of discharge may suddenly increase, indicating that the gland or glands have been cleared. At this point, the doctor can reduce the heat and compression on the area because the treatment has successfully cleared the blocked glands. Without this constant visual feedback, the clinician would be forced to use a standard treatment regimen that may be either insufficient or overly aggressive for the specific obstructed gland(s) in a given patient.

[00230] For reference, in at least each of FIGS. 2D, 2E, 2F, 2G, 2H, 3A, 3B, 15A, 15B and 15D show exemplary embodiments in which the eyelid margin is exposed for visual monitoring by a clinician during treatment. The doctor will stand in front of the eye being treated.

[00231] Referring now to FIG. 16A, which shows a cross-sectional side view of the energy transfer surface 140, the eyelid 14 with the eyelid edge 14a, the scleral screen 300, and the imaging means 160 with the optical path 175. This embodiment is the same as shown in FIG. 2E, except that it is without image converter 155. In the embodiment shown in FIG. 16A, the visualization tools are directly focused on the edge of the 14a century, and more specifically on the meibomian ducts 19.

[00232] In FIG. 16B is a front perspective view of the same embodiment as in FIG. 16A showing an example in which the eyelid 14 is compressed between the energy transfer surface 140 and the scleral shield 300 while the eyelid edge 14a is visible to the clinician from the front. This option is the same as shown in FIG. 2F, without image converter 155.

[00233] In FIG. 16C shows an embodiment similar to that shown in FIG. 16A, with the addition of bracket 262. Bracket 262 is the same as shown in FIG. 3A, 3B, 7H, 7G and 15B.

[00234] In FIG. 16D is a front perspective view of the embodiment shown in FIG. 16C showing a pair of brackets 262 connected to a scleral shield 300. The 14a century edge is open and adjacent to the bottom edges of the brackets 262, by way of example and not limitation. Fig. 16E is the same as FIG. 16D, but with aperture 440 for viewing the edge of the 14a century, highlighted by a bold dotted rectangle. In fig. 16F is a top view of the embodiment shown in FIG. 16D and 16E, which show the energy transfer surface 140 pressing the eyelid against the scleral shield 300, with the edge of the 14th eyelid exposed to visual observation. Fig. 16G is the same as FIG. 16F, but with aperture 440 for viewing the edge of the 14a century, highlighted by a bold dotted rectangle. In one embodiment, the distance between the brackets is from 0.2 inches to 1.2 inches. In one embodiment, the distance between a line defined by the attachment points between the two brackets and the back plate and a line defined by the attachment points between the two brackets and the clamp member is at least 0.04 inches.

[00235] In FIG. 16H is a more detailed side sectional view of the embodiment shown in FIG. 16C further defining the boundaries of the opening 440 in some preferred embodiments. In the figure, line 1 indicates the lower (horizontal) boundary of the hole, and line 2 defines the upper (vertical) boundary. Angle 1 is the angle between lines 1 and 2 and is theoretically approximately 90 degrees, although differences in the anatomical structure of the cheekbones and brow structure may cause variations in these boundaries. In fig. 16I is a more detailed view of the embodiment shown in FIG. 16H, wherein the preferred lower limit of opening 440 is shown by line 4 and the preferred upper limit of opening 440 is shown by line 6. Angle 2 is the angle between horizontal line 3 and line 4 and is preferably from about 5 to about 20 degrees, while angle 4 is between lines 3 and 6 and is preferably between approximately 60 and 80 degrees. Angle 3 is the angle between line 3 and line 5 and is the preferred viewing angle of the 14a century edge through the opening 440 and is preferably about 25 to 50 degrees.

[00236] In FIG. 16J shows an embodiment similar to 16H, except that the power transfer surface 140 is shorter than that shown in FIG. 16H, thereby exposing much of the upper part of century 14 adjacent to the margin of century 14a. In this embodiment, the opening 440 is larger, although the outer boundaries defined by lines 7 and 8 are parallel to the boundaries defined by lines 1 and 2 in FIG. 16H, and the angle 5 between them is therefore also approximately 90 degrees.

[00237] FIG. 16K is similar to the embodiment shown in FIG. 16J, except that the scleral shield 300 extends behind both the upper and lower eyelids, and there are portions of the energy transfer surface 140 that are adjacent to the upper eyelid 12 as well as the lower eyelid 14. In this embodiment, heat and contract both the upper and lower eyelids, not just the lower eyelid. As shown, the arm 262 is coupled to the scleral shield 300, and the energy transfer surfaces 140 are configured to allow the edges of both the upper and lower eyelids to be viewed through the opening 440. Lines 9 and 10 depict the approximate lower and upper limits of the opening 440, thereby defining an angle 6 that is preferably from about 10 to 150 degrees, and more preferably from about 20 to 120 degrees. It will be appreciated that many modifications to the embodiments disclosed herein are possible, some of which may change the optical path and thus change the angles associated with the hole. For example, an image converter such as that shown in FIG. 2E, as well as other means of reflecting, directing or transforming the image of the eyelid margin through the opening to the clinician. Alternatively, the opening may be an optically transparent window extending through the structural member. For example, in FIG. The 16K energy transfer surface 140 may completely cover the treated portions of both the upper and lower eyelids, and rather than having an opening near the eyelid margin, at least a segment of the energy transmission surface 140 may be transparent enough to allow the clinician to view the eyelid margin. In addition, there may be an image sensor, fiber optic harness, or light guide mounted adjacent to or directed toward the eyelid margin, and an image of the eyelid margin may be transmitted electronically or optically to a point beyond the power transfer surface 140. All of these alternative embodiments and others obvious to those skilled in the art are included within the scope of this invention.

[00238] In FIG. 16L shows the embodiment shown in FIG. 16K, front perspective view. As shown, dual arms 262 are connected to the scleral shield 300 and dual energy transfer surfaces 140 are shown adjacent the upper eyelid 12 and lower eyelid 14. As shown, the edges 12a and 14a of the upper and lower eyelids, respectively, are visible, and the meibomian ducts 19 are also visible. FIG. . 16M same as fig. 16L, with hole 440 generally indicated by a bold dotted rectangle.

[00239] FIG. 16N is similar to the embodiment shown in FIG. 16L, but with one bracket 262. FIG. 16O is the same as the embodiment shown in FIG. 16N, but highlighting two holes 440 defined by the gaps between the upper and lower power transfer surfaces 140 and located to the right and left of the central bracket 262. Other combinations of one or more brackets or other structures having one or more holes may be contemplated by those skilled in the art. this field of technology.

[00240] It will be understood that in FIG. 16A-16O show a unique configuration of energy transfer surfaces 140, scleral shields 300, and brackets 262 that define an opening 440 that allows the edges of one or both eyelids to be viewed while heat and compression are applied to a portion of the eyelid being treated. Many other configurations are possible, and only a few illustrative embodiments have been described herein to demonstrate the innovative concept.

[00241] Referring now to FIG. 17A shows an assembly similar to parts of the embodiment shown in FIG. 3A. The power converter module 120 is located adjacent to the proximal end of the energy waveguide module 130. The distal end of the energy waveguide module 130 is adjacent to an energy transfer surface 140 consisting of a face glass 284 (shown in FIG. 17C) and disposable cover member portions 147a and 147b. The portion 147b abuts the eyelid 14. In FIG. 17B is a front view of a power converter module 120 consisting of two infrared LEDs 120a and four greenish-yellow LEDs 120b, all mounted on a substrate. In fig. 17C is an exploded view of the same components described in FIG. 17A-B, including callout 130a for the inner surface of the energy waveguide module 130. In some embodiments, energy waveguide module 130 may be in fixed relationship with energy converter module 120, while in other embodiments, energy waveguide module 130 may be slidable relative to power converter module 120, and in others, power waveguide module 120 may be slidable relative to 130. In a preferred embodiment, the power converter module 120 is stationary, and the energy waveguide module 130 slides back and forth around the power converter module 120. In such a preferred embodiment, when the energy waveguide module 130 is fully extended, it presses the energy transfer surface 140 against the eyelid 14 (or 12 in upper eyelid treatments).

[00242] To maximize the efficiency of transmitting light energy from the power converter module 120 to the power transfer surface 140, the interior surface of the power waveguide module 130 may be coated or lined with a material that is highly reflective for the wavelengths emitted by the power converter module 120. As an example, the interior surface of the energy waveguide module 130 may be coated with a protected silver material, or it may be lined with films such as WRF-150 from Fusion Optix or ESR film from 3M, which are all designed to provide reflectivity. 97% wavelengths from 500 nm to 900 nm.

[00243] In some embodiments, the disposable cover member portion 147a may be made of a plastic or glass material that transmits light energy in the range of 500-880 nm. Acrylic resin is one example of an acceptable material for the disposable cover member portion 147a. The disposable cover member portion 147b is preferably a low hardness material such as silicone to provide a soft surface for pressing against the eyelid surface. Since most silicones are not completely transparent to infrared energy, it is preferable that the thickness of the disposable cover element 147b be approximately 0.02-0.06 inches to minimize energy loss.

[00244] In FIG. 17D shows the distribution of infrared energy transmitted through the eyelid 14 when the module is fully extended (with its distal end approximately 0.5 inches from the highest point on the infrared LED lens). Referring to the graph shown in the upper left corner, the darker areas are the areas with the highest irradiance (watts per square millimeter) and the lighter areas are the ones with the least irradiance. As shown, the highest irradiance is observed near the middle part, and the irradiance drops sharply towards the edges. An asymmetrical X-axis distribution is not ideal because it is desirable to heat the eyelid tissue evenly from one edge to the other. Some asymmetry in the Y-direction is desirable because most blockages that occur in the meibomian glands are near the opening or duct. In the case where the lower eyelid is being treated and the upper edge of the energy transfer surface 140 is aligned with the upper edge of the lower eyelid, it would be preferable for the irradiation profile (and thus tissue heating profile) to be shifted toward the upper edge, thereby also heating the entire eyelid .

[00245] To improve the infrared light irradiance distribution, a partially reflective coating 196 may be applied to the surface of a portion of the disposable cover member portion 147a, as shown in FIG. 17E. In one embodiment, the coating is an apodizing coating that transmits approximately 33% and reflects approximately 67% of energy in the 820-880 nm range. In fig. 17F shows a more detailed view of the coverage pattern with two zones 196a and 196b shown. In fig. 17G shows the resulting irradiance distribution across the eyelid when using an apodizing coating. As shown, the area of highest irradiance is much wider and offset towards the top edge, and the drop in irradiance towards the right and left edges along the top edge is much smaller. Essentially, there will be preferential heating of the tissue along the upper half of the eyelid (if treating the lower eyelid) and heating from left to right across the eyelid will be more uniform.

[00246] If the apodizing coating 196 also reflects wavelengths in the greenish-yellow region (500-600 nm), then very little greenish-yellow light will reach the desired parts of the eyelid and therefore there will be less heating of the eyelid tissue due to the absorption of greenish-yellow light energy by the chromophores. yellow light. To solve this problem, in one embodiment, it is preferred that the coating region 196a be partially reflective for infrared radiation only (67% reflectance, 33% transmittance for 820-880 nm; >90% transmittance for 500-nm chartreuse). 600 nm) and that the coverage area 196b be partially reflective (67% reflectance, 33% transmittance) for both infrared (820-880 nm) and greenish-yellow (500-600 nm).

[00247] In FIG. 17H shows a graph of the chartreuse irradiance distribution on the surface of the eyelid for an embodiment having an apodizing coating as described above (zone 196a transmits chartreuse and partially reflects infrared radiation, and zone 196b partially reflects both). As can be seen, the irradiance pattern is predominantly shifted towards the upper half of the eyelid and is well distributed from the right to the left edge without a significant drop in irradiance.

[00248] It will be appreciated that the examples of coating types and application patterns disclosed herein are merely demonstration examples and that alternative configurations may result in a more uniform irradiance distribution across the desired spectra. For example, another way to create a heating pattern for the eyelid is to change the application pattern or properties of the energy-absorbing surface 302 of the scleral shield 300 (as shown in FIG. 3B). For example, in order to equalize the heating of the scleral screen, if the irradiation scheme is as shown in FIG. 17D, the right and left portions of the surface of the scleral shield 300 may be more densely coated with energy-absorbing material than the central portions of the scleral shield 300. In addition, to shift the heating toward the upper portion of the eyelid, the upper portion of the surface of the scleral shield may be more densely coated with the energy-absorbing material. Combinations of coatings on elements within the energy transfer path, as well as changes in the reflective and energy absorption properties of the scleral shield surface are all included within the scope of the present invention.

[00249] In FIG. 18A and 18B show another embodiment of an eye treatment device 200. In some embodiments, the eye treatment device 200 may be adapted for use by an ophthalmologist (OP). For example, the eye treatment device 200 may allow the SOF to apply localized heat and pressure to the eyelids 12, 14 (not shown in FIGS. 18A-18B). In some embodiments, the system may include a hand-held instrument 1800 adapted to be coupled to a sterile disposable component 260 located behind the eyelids 12, 14. For example, the sterile disposable component 260 may be single-use, removable, or disposable. In some embodiments, the sterile disposable component 260 may be removably attached to the handheld instrument 1800, and the handheld instrument 1800 may include a disposable portion release button 1805. In some embodiments, the hand tool 1800 also includes a power button 1807. In some embodiments, the eye treatment device 200 may allow the SOF to view the eyelid margin through an imaging device or imaging means 160, such as a built-in camera. The eye treatment device 200 may then heat the eyelid tissue to a target temperature range, for example, to melt meibomian gland secretion blocking the openings. In embodiments, the target temperature range is from about 40°C to about 42°C. The eye treatment device 200 may further apply pressure to the eyelids 12, 14, for example to force molten meibomian gland secretion through the openings. In some embodiments, the amount of heat applied and the amount of pressure applied are constantly under the direct control of the SOF, and the SOF can monitor glandular response and patient comfort during treatment.

[00250] As shown in FIG. 18A-18B, the eye treatment device 200 may include an electronic hand-held instrument 1800. The hand-held instrument 1800 may be used in conjunction with a sterile disposable component 260, for example, to apply heat and pressure to the eyelids 12, 14. The eye treatment device 200 may have an approximate size of 8 inches (L) x 1 ½ inches (W) x 2 ¼ inches (H). The eye treatment device 200 may have other dimensions without departing from the scope of the present invention. In some embodiments, the sterile disposable component 260 may be attached to the hand-held instrument 1800 by at least two latches 1801. The at least two latches 1801 may engage at least one fastening tab 2203 (not shown). The sterile disposable component 260 can be removed from the hand-held instrument 1800 by pressing the disposable release button 1805. The eye treatment device 200 may include electronic circuits that sense temperature sensors 310 in the inner eyelid pad 300 and the outer eyelid pad 147. Electronic circuits can be used to measure temperatures that characterize the temperatures of the inner surface of the eyelid and the outer surface of the eyelid. Heating may be accomplished using light energy emitted from the LEDs in the hand tool 1800. A mechanism in the hand tool 1800 may allow an operator to apply pressure to the eyelid by controlling the movement of the outer eyelid pad 147 using finger pressure applied to the compression control button 1822. In some embodiments, the eye treatment device 200 may also include a graphical screen or display 244 configured to display information used to operate the hand-held instrument 1800, such as during treatment. In some embodiments, the eye treatment device 200 may include an imaging device or imaging means 160 configured to allow an operator to view the eyelid margin during treatment.

[00251] Eyelid temperature can be measured using sensors 310 in a sterile disposable component 260 containing two sensors in an outer eyelid pad 147 and two sensors in an inner eyelid pad 300. For example, these sensors may be mounted on a flexible printed circuit board (PCB), which may also have a set of pads. When the sterile disposable component 260 is attached to the hand-held instrument 1800, spring-loaded pins mounted underneath the housing 2100 (not shown) may provide electrical connection to the outer eyelid pads 140 and the inner eyelid pads 300 in the sterile disposable component 260. In some embodiments, an electronic The circuitry in the 1800 hand tool can read sensors and detect temperatures quickly, for example, more than 20 times per second. The accuracy of the temperature measurement system can be ±1°C. In some embodiments, the electronic circuitry performs its own testing to ensure that the sensors are operating correctly. For example, if the electronic circuit detects a fault, an error code may be displayed and the heat source may be turned off.

[00252] In some embodiments of the eye treatment device 200, the pressure applied to the eyelid may be controlled by the SOF, for example, by pressing the SOF compression control button 1822 with a thumb or other finger. This pressing of the compression control button 1822 may cause the outer eyelid pad 147 to move toward the opposing inner eyelid pad 300 . In some embodiments, when the sterile disposable component 260 is attached to the handheld instrument 1800, the outer eyelid pad 147 is automatically attached to the front of the housing 2100. The housing 2100 may be a movable component that encloses heating LEDs and directs light to the eyelid. In some embodiments, the compression control button 1822 is coupled to the housing 2100, thereby allowing the clinician to advance the outer eyelid pad 147 using thumb or finger force. For example, the applied force may be measured by a sensor mounted in the compression control button mechanism 1822 and may be displayed on the display screen 244 as a relative number from 1 to 9. The displayed value may be a relative reference value for the clinician. The actual force applied should be determined by clinical judgment, taking into account the condition and response of the eyelid being treated and the sensitivity of the patient.

[00253] In some embodiments, the eyelid tissue may be heated by light energy produced by LEDs in the handheld instrument 1800 and passed through the clear outer eyelid pad 300. The LEDs may be located behind a transparent window at the open end of the housing 2100. For example, two wavelengths of light may be used: chartreuse and near-infrared. Chromophores in the eyelid can absorb light energy and thereby heat the surrounding tissue.

[00254] In some embodiments, the top surface of the compression control button 1822 has a heater control switch 1802 that can be moved forward by the operator's thumb or index finger, thereby turning on the heater LEDs. This heater control switch 1802 may have a spring return element such that when it is released, or when the operator's thumb or index finger relaxes, the heater control switch 1802 returns to its normal "off" position.

[00255] In some embodiments, the eye treatment device 200 may be configured to protect the eye from unintentional exposure to light. For example, the inner eyelid liner 300 and eye shield may block light 211 that shines directly into the eye during treatment. In some embodiments, the handheld instrument 1800 may turn off the heating of the LEDs if the actual sterile disposable component 260 is not attached to the handheld instrument 1800 or if the outer eyelid pad 147 is more than 6 mm away from the inner eyelid pad 300.

[00256] In FIG. 19 shows an example of a front plate or force pad used as an outer eyelid pad 147 that can be inserted between the eye treatment device 200 and a patient's eyelids 12, 14, for example, to provide a barrier therebetween. In some embodiments, the outer eyelid liner 147 may be a clear outer eyelid liner 147 that can act as a window through which energy can be delivered to the eyelids 12, 14. For example, the clear outer eyelid liner 147 can be made from any suitable material such as glass, pyrex, quartz, mica or polymers such as polycarbonate or other optically transparent materials, or combinations thereof, to obtain the desired structural and optical properties. In embodiments, the outer eyelid pad 147 may be adapted to be in direct contact with the eyelids 12, 14 of a patient. In other embodiments, the outer eyelid pad 147 may be adapted to be placed at a close distance from the eyelids 12, 14, such as 0.5-12 mm from the eyelid during treatment. Preferably, the outer surface of the outer eyelid liner 147 is smooth and easy to clean. For example, the clear outer eyelid liner 147 may be configured to be relatively movable along a movement path 145 relative to either the energy converter module 120 or the scleral shield 300 or the housing 202 to ensure that the clear outer eyelid liner 147 can be pressed against the eyelids 12 14. The pressure of the transparent outer eyelid pad 147 on the eyelids 12, 14 may serve to minimize photon energy leakage during treatment and/or imaging and, if necessary, to apply compressive force to the eyelids 12, 14 during assessment and/or extrusion. meibomian glands.

[00257] In FIG. 19 shows an embodiment of an outer eyelid pad 147 that includes an array of temperature sensors 310 positioned toward the outer surface of the eyelid. In some embodiments, the array of temperature sensors 310 may be discrete elements (such as thermocouples made of very fine wire, miniature thermistors, etc.) built into or located in the outer eyelid pad 147. Additionally and/or alternatively, the array of temperature sensors 310 may be thermocouples formed by depositing a thin film or films of appropriate metals onto the intermediate layers of the outer eyelid pad 147. In some embodiments, the preferred types of materials for the outer eyelid liner 147 are soft, flexible, biocompatible materials such as silicone, polyurethane, and various hydrogels like those used in contact lenses.

[00258] In embodiments, the outer eyelid pad 147 may also include a plurality of protuberances on the eyelid-facing surface, for example to create an air space for an array of temperature sensors 310.

[00259] The array of temperature sensors 310 may be configured to determine the position of the eye treatment device 200 relative to the eyelids 12, 14 of the patient. The set of temperature sensors 310 may be temperature sensors that measure the temperature of the room before the eyelid is placed in the device. Since the temperature sensor array 310 is located near the skin of the eyelid, the temperature sensor array 310 will record a value closer to body temperature and therefore confirm correct placement. If the set of temperature sensors 310 do not match, for example, one sensor indicates room temperature and another sensor indicates eyelid temperature, this may be an indication that the eyelid is not positioned correctly in the eye treatment device 200 for treatment.

[00260] In FIG. 19 shows an embodiment of a front plate or outer eyelid pad 147 having sensors 310 for measuring eyelid temperature. When infrared light waves strike the skin, some of the light is reflected back to the sensors 310 and may heat the sensors 310. This may cause the temperature of the eyelid to be measured incorrectly. In some embodiments, to prevent unwanted photonic heating of the sensors 310, reflective and/or white paint may be used to coat the sensors 310.

[00261] Referring again to FIG. 19, when infrared light waves hit the skin, they are absorbed and the light energy is converted into heat, thereby heating the skin. Generally, darker skin colors absorb more infrared light than lighter skin colors, which means darker skin warms up faster as it converts more light into heat.

[00262] Using this knowledge, the eye treatment device 200 can detect differences in skin pigmentation and adjust treatment accordingly. For example, the eye treatment device 200 may have sensors 310 on the front plate and the fixed back plate for measuring the temperature of the inner surface of the eyelid and the temperature of the outer surface of the eyelid during heating. If the outer surface of the eyelid heats up quickly, this may indicate a darker skin color, and conversely, if the outer surface of the skin heats up slowly, this may indicate a lighter skin color.

[00263] In some embodiments, to compensate for this difference in heating rates for different levels of skin pigmentation, the eye treatment device 200 may adjust the light so that the inner and outer skin are heated at the same rate. For example, the frequency of the light can be adjusted for a slowly heating surface, for example to increase the heating rate so that the inner and outer surfaces of the eyelid are heated at the same rate. If the skin on the inner surface of the eyelid needs additional heating, the eye treatment device 200 may turn on the green light and turn off the infrared light. In another embodiment, the light used may be multiple wavelengths to adjust between the plates and maintain uniform heating.

[00264] Some embodiments of the eye treatment device 200 may include a first set of sensors that may be located on the surface of the transparent outer eyelid pad 147 and facing the outer surface of the eyelid to monitor the temperature of the outer surface of the eyelid, and a second set of sensors that may be connected to the scleral screen 300 on the surface facing the inner surface of the eyelid for monitoring the temperature of the eyelid surface. Such placement may allow thermocouples or thermistors to sense the temperature of the outer and/or inner surfaces of the eyelid. For example, the first set of sensors and the second set of sensors may be coupled to the control device 212, and the sensors may be configured to detect the temperature of the outer surface of the eyelid and/or the inner surface of the eyelid and transmit the temperature information to the control device 212. Monitoring the temperatures of such surfaces can help ensure that a patient does not experience significant discomfort or injury from using the eye treatment device 200.

[00265] In some embodiments, the first set of sensors and the second set of sensors may be security sensors. The first set of sensors and the second set of sensors may preferably be non-contact sensors, such as pyroelectric sensors (eg, IRA-E700ST0 from Murata), or thermopile sensors (eg, ST25T0-18 from Dexter Research, Dexter, Mich.), or conventional temperature monitoring devices such as a thermocouple, thermistor, fiber optic temperature sensor, or digital temperature sensor (for example, Dallas Semiconductor DS-18B20). In some embodiments, the first set of sensors and the second set of sensors may be discrete elements (such as, for example, thermocouples made of very fine wire, or miniature thermistors, etc.) built into the outer eyelid pad 147 (such as , e.g., located within the pocket) and/or scleral shield 300. In some embodiments, the first set of sensors and the second set of sensors may be formed by depositing thin films of appropriate metals onto the surface layers and/or intermediate layers of the outer eyelid liner 147 and/or scleral screen 300.

[00266] In some embodiments, the eye treatment device 200 may include current sensing circuitry to monitor the operation of the LED. The current sensing circuit may be a circuit that is configured to measure current passing through the current sensing circuit to the LED. For example, the current sensing circuitry may be configured to detect fault conditions, such as a short circuit or open circuit in the current path, which may be associated with wiring problems and/or problems with the LED. In such current sensing circuits, it is important not only to detect the condition, but also to ensure the safe operation of the detection circuit itself. If a malfunction is detected, the system may shut down the faulty circuits and/or shut down the eye treatment device 200. In such cases, error codes may be displayed on the screen to alert the user or clinician to the fault condition.

[00267] In some embodiments, after the temperature of the eyelids 12, 14 reaches a target temperature range, such as a treatment temperature, the user or clinician may need to know how long the eyelid remains within the target temperature range. For example, the target temperature range may be between the minimum temperature required to treat an eye disease and the maximum temperature above which discomfort or thermal damage to the eye or eyelid may occur. In some such embodiments, the target temperature range is from about 40 to about 80 degrees Celsius. In some embodiments, the target temperature range is from 50 to 80 degrees Celsius. In some embodiments, the target temperature range is from 60 to 80 degrees Celsius. In some embodiments, the target temperature range is from 70 to 80 degrees Celsius. In some embodiments, the target temperature range is from 40 to 70 degrees Celsius. In some embodiments, the target temperature range is from 40 to 60 degrees Celsius. In some embodiments, the target temperature range is from 40 to 50 degrees Celsius. In some embodiments, the target temperature range is 40 to 45 degrees Celsius.

[00268] As shown in FIG. 20, the eye treatment device 200 may include a melt time indicator configured to count the time the eyelids 12, 14 are within a target temperature range. The melting time may be displayed on the display 244 of the hand tool 1800. For example, a timer may start a counter once the temperature of the eyelid reaches a minimum temperature and may continue to count until the temperature drops below the minimum temperature. In some embodiments, the timer may use the temperature actually measured at the time of measurement, while in other embodiments, the timer may use a preset amount of time.

[00269] In FIG. 20 shows an embodiment of a dashboard 218 of a display screen 244 adapted to display the status of the eye treatment device 200. For example, the instrument panel 218 may include a temperature measuring device or means configured to measure various eyelid temperatures, such as internal and/or external surface temperatures, a data logger 214, a voice recorder 213, a battery configured to supply power to components of the instrument panel, battery charging means, a control device, a printed circuit board, and/or a communication circuit between the scleral screen 300 and the energy converter 205.

[00270] In some embodiments, the eye treatment device 200 may further comprise a display screen 244 adapted to display the temperatures of the inside of the eyelid and the outside of the eyelid. For example, a temperature display element may display absolute temperatures or may display relative temperatures compared to a maximum. For example, temperatures may be displayed in a bar graph format or using one or more light signals, etc.

[00271] In some embodiments, the temperature of the inner and/or outer surface of the eyelid during use of the eye treatment device 200 may be measured and displayed to the clinician on the display screen 244. For example, the clinician can apply thermal energy to the eyelid, and when the temperature of the eyelid reaches the treatment temperature, the clinician can apply a compressive force while visually monitoring the eyelid margin to optimize the expulsion of secretions from obstructed meibomian glands.

[00272] In FIG. 21A and 21B show another embodiment of an eye treatment device 200. In fig. 3A is a schematic side plan view of an embodiment of the eye treatment device 200 shown in FIG. 21A, 21B, in which the eye treatment device 200 is in an operative state and transmits light 211 to the eyeball 20 and the tissue being treated. In some embodiments, a movable optical waveguide or housing 2100 having an internal reflective surface may be used to reflect or direct light 211 toward the energy transfer surface 140, thereby increasing the efficiency of heating the target tissue. In fig. 21A the housing 2100 is shown in the retracted position, and in FIG. 21B, housing 2100 is shown in the extended position. For example, the housing 2100 may be used when the light 211 emitted from the energy converter module 120 contains a portion of the light 211 initially emitted at such an angle that, without correction, the light 211 will not reach the energy transfer surface 140 to pass to the tissue being treated. A movable optical waveguide, or housing 2100, can be used to correct this and focus the light 211 towards the tissue being treated.

[00273] In some embodiments, the movable reflector, optical waveguide, or housing 2100 may be a sliding assembly surrounding the heat source LEDs and directing the light 211 toward the eyelid. For example, a user or clinician may control the movement of the housing 2100 by pressing a compression control button 1822 coupled to the housing 2100. In some embodiments, when a sterile disposable component 260 is attached to the hand-held instrument 1800, the outer eyelid pad 147 may be automatically attached to the front portion housing 2100. When the clinician presses the compression control button 1822, the housing 2100 and the outer eyelid pad 147 can be extended in the direction of the eyelid. In some embodiments, the outer eyelid pad 147 is positioned on the surface of the eyelid to heat the eyelid without compressing it. In other embodiments, the eyelid is compressed between the outer eyelid pad 147 and the stationary backplate. For example, when the clinician presses the compression control button 1822 with a thumb or other finger, the housing 2100 and outer eyelid pad 147 are extended toward the stationary backplate. In this way, the amounts of heat supplied and pressure applied can be directly controlled by the clinician, who can monitor glandular response and patient comfort.

[00274] In some embodiments, the surface of the inner wall of the housing 2100 may be smooth and/or polished to avoid or minimize the scattering of light 211 when it experiences reflection from the walls. For example, the walls may have a mirror surface such that the reflection of light 211 is retained within the housing 2100 even when light 211 strikes the side walls. In embodiments, the mirror surfaces on the walls can be achieved by depositing a reflective layer or layers using any known means, such as, for example, silvering, aluminizing or mirror film lamination, or other types of mirror finishes, to further increase the light conducting ability of the housing 2100 211.

[00275] In FIG. 22 and 23 show an embodiment of the front spacer of the eye treatment device. For example, the outer eyelid pad 147 may be positioned between the light source of the eye treatment device 200 and the outer portion of the patient's eyelid. The outer eyelid liner 147 may be configured to come into contact with the housing 2100 when the housing 2100 is pulled out for treatment. Because the housing 2100 may become hot during treatment, the outer eyelid pad 147 may include a frame around its perimeter to engage the walls of the housing 2100 to prevent the outer eyelid pad 147 from heating up.

[00276] In some embodiments, the outer eyelid pad 147 may be used to shield the eye from thermal energy, but may alternatively be used to measure temperatures. For example, the outer eyelid liner 147 may be made of materials that are substantially transparent to energy emitted from the energy converter. As a specific example, if the energy converter is a light source, the outer eyelid pad 147 may be made of a transparent material that does not block the wavelength(s) of light emitted by the energy converter.

[00277] In FIG. 22 illustrates embodiments of a sterile disposable component 260. In embodiments, the sterile disposable component 260 includes the following exemplary components: an inner eyelid liner 300, an outer eyelid liner 147, an eye shield 264, a silicone sheath 2201, fastening tabs 2203, a guide 2204, and brackets. 2205.

[00278] The inner eyelid pad 300 may be made of a plastic material configured to be heated by a light-based heat source in the hand tool 1800. In embodiments, the plastic portions may be surrounded by a soft, biocompatible silicone shell 2201. In embodiments, there are two sensors 310 temperatures, which are located in the inner eyelid pad 300 and are configured to measure the temperature of the inner surface of the eyelid. The inner eyelid pad 300 is also called the back plate.

[00279] The outer eyelid liner 147 may be configured as a clear, biocompatible silicone liner mounted on a plastic frame. In embodiments, the plastic frame at the location of the temperature sensors 310 has a minimum thickness of 0.010 inches. In some embodiments, the outer eyelid liner 147 is in contact with the patient during treatment. If a sterile disposable component 260 is attached to the handheld instrument 1800, the frame may be attached to the housing 2100 of the handheld instrument 1800. Light from a heat source in the handheld instrument 1800 may shine through the outer eyelid pad 147, heating the eyelid tissue. In some embodiments, there are two temperature sensors 310 that are located in the outer eyelid pad 147 and are configured to measure the temperature of the outer surface of the eyelid.

[00280] The eye shield 264 may block light emitted from the hand tool 1800 and thus protect parts of the eye not intended to be heated. In embodiments, the inner eyelid pad 300 and portions of the eye shield 264 may be coated with a soft biocompatible silicone component or silicone shell 2201. For example, at the location of the temperature sensors 310, the silicone shell 2210 may have a minimum thickness of 0.010 inches. In some embodiments, the silicone sheath 2201 is in contact with the patient during treatment.

[00281] The sterile disposable component 260 may be attached to the hand-held instrument 1800 by fastening tabs 2203. For example, when the sterile disposable component 260 is attached to the hand-held instrument 1800, spring-loaded latches may engage the holes in each of the fastening tabs 2203, thereby securing the sterile disposable component 260 to the hand-held instrument 1800. A guide 2204 may assist in the alignment of the sterile disposable component 260 relative to the hand-held instrument 1800. Brackets 2205 may connect the inner eyelid liner 300 to the body of the sterile disposable component 260. These brackets 2205 serve as a guide for insertion of the inner eyelid liner 300. century by eyelid to the proper depth.

[00282] In FIG. 23 is an exploded view of the sterile disposable component 260, showing an embodiment of temperature sensors 310 on the outer eyelid pad 147. Any of the gaskets shown in FIG. 23 may be formed from several parts or may be one monolithic part. In embodiments, temperature sensors 310 may be configured to measure the temperature of the outer portion of the eyelid. In use, light 211 may fall on the rear of the temperature sensor array 310. If this occurs, the temperature sensors 310 may read the temperature of the light rather than the temperature of the eyelid. To avoid this, the back of the temperature sensors 310 may be coated with a material that does not heat up. For example, the back of the temperature sensors 310 may be coated with a reflective coating to reflect light 211 away from the temperature sensors 310 without heating the back of the temperature sensors 310.

[00283] In FIG. 23 shows an embodiment of a sterile disposable component 260 that is designed for single use and is not intended for reuse. In some embodiments, to track the number of uses, the sterile disposable component 260 may include an embedded memory containing user treatment parameters. For example, user treatment parameters may contain the available number of uses, such as for a sterile disposable single use component 260, and communicate this information to the eye treatment device 200. When the eye treatment device 200 is used for treatment, not all user treatment parameters will allow it to be used again. In some embodiments, upon attachment of the sterile single-use component 260, usage information may also be displayed on the display 244 to let the user know that the sterile single-use component 260 can only be used for a single use.

[00284] In some embodiments, the sterile disposable component 260 may be designed for reusable use. For example, the on-chip memory may track the number of uses, and when the maximum number of uses is reached, the eye treatment device 200 will not allow treatment with that sterile disposable component 260. When the sterile disposable component 260 is attached, this information may be displayed on the display 244, indicating the number of remaining uses available. When the eye treatment device 200 is used for treatment to the maximum number of allowed uses, not all user treatment parameters will allow it to be used again.

[00285] In FIG. 23 and 24 show an embodiment of a fixed backplate, or fixed inner eyelid liner 300. In embodiments, the fixed inner eyelid pad 300 may be adapted to be positioned between the eyelids 12, 14 and the eyeball 20 so as to cover the sensitive structure of the eye system 10 and prevent light 211 from contacting the eyeball 20. For example, the fixed inner eyelid pad 300 may comprise a reflective surface configured to receive light 211 and reflect light 211 toward the inner surface of the eyelid to heat it.

[00286] In some embodiments, the fixed inner eyelid pad 300 may include a set of temperature sensors 310 positioned toward the inside of the eyelid. For example, this array of temperature sensors 310 may be discrete elements (such as thermocouples made of very fine wire, miniature thermistors, etc.) built into or located in the fixed inner eyelid pad 300. In some embodiments, the array of temperature sensors 310 may be thermocouples formed by depositing thin films of appropriate metals onto the interlayers of the stationary eyelid liner 300.

[00287] In embodiments, to prevent the fixed eyelid liner 300 from heating the set of temperature sensors 310, the energy-absorbing surface or reflective surface of the fixed eyelid liner 300 may include sensor windows so that the temperature sensors 310 of the set pass through and thereby enter in direct contact with the inner surface of the eyelid.

[00288] In FIG. 19 and 24 are views showing details of embodiments of the front plate or outer eyelid pad 147 and the back plate or inner eyelid pad 300. In some embodiments, temperature sensor arrays 310 are redundant sensors that are placed adjacent to each other for the purpose of redundancy and increased accuracy. Each set of temperature sensors 310 may provide primary and secondary eyelid temperature measurements. The secondary eyelid temperature result can be used in combination with the primary temperature result to improve the accuracy and reliability of temperature determination.

[00289] In some embodiments, obtaining two or more eyelid temperature readings increases redundancy. One aspect of the present invention includes the step of comparing a primary eyelid temperature reading and a secondary eyelid temperature reading to determine whether both sensors of the set of temperature sensors 310 are operational.

[00290] The set of temperature sensors 310 may be subject to mechanical and/or thermal stress, and one of the sets of temperature sensors 310 may stop operating. Having a redundant set of temperature sensors 310 may allow the system to use a second set of temperature sensors 310 to provide the temperature information needed to complete the procedure.

[00291] In some embodiments, the sets of inner and outer eyelid temperature sensors 310 may be redundant temperature sensors 310. For example, each set of temperature sensors 310 may measure the temperature of the inner surface of the eyelid or the temperature of the outer surface of the eyelid. Both sets of temperature sensors 310 should indicate the same temperature. If the temperature readings provided by the temperature sensor sets 310 do not match, it may indicate that the treatment is not positioned correctly on the eyelid, or that there is a problem and the system should be turned off.

[00292] In FIG. 23 and 24 show an embodiment of a sterile disposable component 260 containing an identification (ID) chip. The ID chip may provide counterfeit protection for disposable parts by ensuring that genuine sterile disposable parts 260 are used in treatment. The ID chip may also provide automated treatment tracking by monitoring the use of sterile disposable parts 260 and strictly following guidelines regarding the maximum number of uses of the disposable parts. parts. Additionally, the ID chip can facilitate visual inventory control through real-time supply and inventory management for direct purchasing and shipping.

[00293] In some embodiments, ocular treatment device 200 may employ authentication methods and/or protocols to determine whether the sterile disposable component 260 is counterfeit. For example, the eye treatment device 200 may include a communication protocol configured to be capable of distinguishing between an approved sterile disposable component 260 and an unapproved copy. The communication protocol may be further configured to allow the eye treatment device 200 to reject the sterile disposable component 260 if it is determined to be an unapproved copy. In some embodiments, the eye treatment device 200 may also include a mechanism for limiting the use and/or counting the number of uses of the sterile disposable component 260 and allowing the eye treatment device 200 to reject the sterile disposable component 260 if it exceeds its maximum allowable use and/or or number of uses.

[00294] In some embodiments, the sterile disposable component 260 includes an embedded memory containing user treatment parameters specific to the type of sterile disposable component 260 that is being used. For example, when the sterile disposable component 260 is attached to the eye treatment device 200, the eye treatment device 200 can read treatment parameters and adjust the treatment to match user parameters.

[00295] In some embodiments, the eyes use different sterile disposable components 260 during treatment. Therefore, user treatment parameters may include light settings for each of the different sterile disposable components 260. For example, some of the sterile disposable components 260 may have different back plate designs and therefore, they may require different treatment settings. In some embodiments, the backplate may include an energy-absorbing portion that heats up and then transfers heat to the inside of the eyelid. In other embodiments, the backplate may have a reflective surface that reflects light energy back onto the eyelid for heating.

[00296] In some embodiments, the sterile disposable component 260 may be used to acquire images of the eyelid, and user parameters may include a light-off feature to ensure that no light is illuminated.

[00297] In some embodiments, the sterile disposable component 260 can be used for both treatment and video recording. For example, a treatment setting may include alternating recording of video clips with radiation-based heating so that the video does not blur.

[00298] In FIG. 19, 22, 23 and 24 are embodiments showing a sterile disposable component 260, which is a sterile single-use component that contains all parts intended to contact the patient's eyelid. Before use and attachment to the hand-held instrument 1800, the sterile disposable component 260 is removed from its packaging.

[00299] The hand-held instrument 1800 is a hand-held eye treatment device 200 that allows the SOF to examine, heat, and compress the portion of the eyelid in contact with the sterile disposable component 260. The heating source is optical radiation generated by the yellow-green and infrared LEDs in the hand-held instrument. 1800.

[00300] In some embodiments, power to operate the hand tool 1800 is provided by an internal rechargeable lithium-ion battery. For example, the battery can be recharged by placing the hand tool 1800 in a separate charging rack that receives AC power.

[00301] The main parts of the sterile disposable component 260 are shown in FIG. 22. In some embodiments, the sterile disposable component 260 may have approximately dimensions of 1.5 inches (length) x 1 inch (width) x 1 inch (height). The sterile disposable component 260 may have different sizes without departing from the scope of the present invention. In embodiments, the sterile disposable component 260 may be a sterile component used to treat a single patient and then discarded. For example, during treatment, the inner eyelid pad 300 may be inserted behind the eyelid into the superior fornix of the conjunctiva and may be designed to come into contact with the inner mucosa (ie, the conjunctiva of the eyelid). An outer eyelid liner 147 opposed to an inner eyelid liner 300 may be in contact with the skin on the outer surface of the eyelid. Light 211 generated by hand tool 1800 may be passed through the transparent outer eyelid pad 147 to heat the eyelid tissue. The outer eyelid pad 147 can be used to apply pressure to the eyelid by moving toward the inner eyelid pad 300 through a mechanism in the hand tool 1800. Temperature sensors 310 in the outer eyelid pad 147 and the inner eyelid pad 300 can monitor the temperature of the eyelid. during treatment.

[00302] The embodiment of the sterile disposable component 260 shown in FIG. 19, 23 and 24 may further comprise a front and/or rear drug-releasing pad configured to contact the eyelid and transfer the drug to the outer and/or inner surface of the eyelid. Medicines can be used to treat a variety of diseases. For example, the drug-releasing pads may contain one or more of the following: an anesthetic, for example, to block nerves in the eyelid from feeling pain or discomfort during treatment; an antibiotic, for example to treat blepharitis, reduce inflammation or reduce symptoms more quickly; and/or a steroid, for example, for the treatment of inflammatory skin diseases, including atopic dermatitis, psoriasis, steatosis, contact dermatitis, and the like. There are therapeutic drugs that do not require additional assistance to penetrate the skin of the eyelid, such as, for example, electrophoresis.

[00303] Electrophoresis is a method for non-invasive transdermal delivery of drugs to the skin of the eyelid based on the transfer of charged molecules using low-intensity electrical current. In some embodiments, the ocular treatment device 200 may deliver drugs by infusing the drug into the eyelid using electrophoresis. For example, disposable pads may contain a drug, and when infusing the drug by electrophoresis, a weak electrical current may be used to stimulate the passage of drug-carrying ions through the eyelid. The electrical current can be delivered by a sterile disposable component 260 or a hand-held instrument 1800. In some cases, local anesthesia may be required to treat the eyelids in patients fearful of pain. In these cases, lidocaine can be delivered to the eyelid using a drug infusion using electrophoresis.

[00304] In some embodiments, the eye treatment device 200 may be configured to treat a hordeolum and/or a chalazion. Chalazions and hordeolums (styes) are sudden onset localized tumors of the eyelid. Chalazion is caused by non-infectious occlusion of the meibomian glands, whereas hordeolum is usually caused by infection. Both diseases initially cause eyelid hyperemia and swelling, swelling and pain.

[00305] To treat a hordeolum, the inner eyelid liner 300 and/or the outer eyelid liner 147 may include elements for focusing pressure on the stye or pimple to compress the eyelid and drain the hordeolum. To treat a chalazion, the inner eyelid liner 300 and/or the outer eyelid liner 147 may include elements to focus pressure on the occluded meibomian gland to open the gland.

[00306] In some embodiments, the eye treatment device 200 may include an integrated camera as imaging means 160. For example, the built-in camera or built-in visualization 160 may allow the user to determine how treatment is progressing before, during, or after treatment. In some embodiments, the integrated imaging tools 160 may include fixed optics, adaptive optics, and/or active optics for viewing different areas of the eyelid, including the anterior surface, posterior surface, and lid margin. For example, adaptive and active optics may be configured to focus and/or zoom on an image or target area. When viewing the eyelid margins, the built-in imaging tools 160 can observe gland extrusion. By viewing the back of the eyelid using a light illuminating the front of the eyelid, the built-in imaging tools 160 can view the internal structure of the eyelid glands.

[00307] In some embodiments, embedded renderers 160 may provide video and/or still images of the eyelid. The built-in rendering facilities 160 may be further coupled to electronics, for example, to record and/or transmit images to an external device. In some embodiments, these electronics may include built-in imaging tools 160. In some embodiments, the embedded rendering means 160 may be coupled to a control device of the device, wherein the control device is configured to store and/or transmit still images and/or video recordings.

[00308] The mammalian eyelid is curved, but this curvature does not seriously impair direct visual observation by viewing due to the natural ability of the eye to accommodate curvature (refocus). However, when using a camera, field curvature causes defocus error, which can be significant. Field curvature can be corrected by placing a single thin lens directly in front of the final focus. With proper selection of parameters, the thin lens smoothes the field while causing very little aberration. In some embodiments, a field smoother may be used to smooth out a curved image. For example, a field smoother can provide greater focus across the entire field.

[00309] In some embodiments, the eye treatment device 200 may be configured to contain an integrated video screen. In some embodiments, the video recording may be recorded to a storage device in the device, or the video recording may be recorded to a portable storage medium such as a microSD. Once the procedure is complete, the portable media can be removed and replaced with blank media for the next procedure.

[00310] When the built-in renderers 160 capture video during treatment, the light 211 used for heating may blur the captured videos or images. One solution is to alternate between video recording and radiation-based treatment. In fig. 25 shows the pulsation of the radiation source and the built-in imaging means 160: for example, when the radiation is turned off, the camera turns on, and when the radiation arrives, the camera turns off. This may enable shooting without distortion due to light 211.

[00311] In some embodiments, the eye treatment device 200 may include a dedicated photographic disposable portion, for example, for taking pre- and post-treatment photographs of the eyelid. For example, the photographic disposable portion may be similar to the sterile disposable component 260, but may use a spacer instead of a fixed backplate 300 to position the eyelid in the correct position. The special photographic disposable part does not include a back plate 300 because the radiation 211 is not turned on and does not shine in the direction of the eye. When used, the photographic disposable part can initially be used for pre-treatment photography. The photographic disposable portion can then be replaced with a sterile disposable component 260. Once treatment is complete, the sterile disposable component 260 can be removed and replaced with the photographic disposable portion.

[00312] In some embodiments, the photographic disposable portion may include a memory containing parameters for modifying camera settings according to user requirements. For example, the photographic disposable part may be configured to control the radiation used depending on the photography settings. For example, one setup may direct the eye treatment device 200 to illuminate the eyelid with white light for imaging purposes, while another setup may involve using infrared light to take photographs.

[00313] In some embodiments, the photographic disposable portion may include a diffractive surface to alter the radiation path. When the angle of radiation passing through a surface changes, refraction occurs. A diffractive surface can narrow the light beam, broaden the light beam, or scatter the light beam. In some embodiments, it may be necessary to diffraction the radiation into a narrow beam to focus on the area to be treated on the eyelid. In some embodiments, it may be necessary to widen the light beam to increase the width of the treatment area on the eyelid. In some cases, diffraction of radiation may be required to provide more uniform coverage of the treatment area.

[00314] In some embodiments, the eye treatment device 200 may be configured to stream video using built-in visualization tools 160. For example, embedded imaging 160 and/or eye treatment device 200 may include a wireless communication link for sending video to an external device, such as an external viewing monitor, or for streaming video to another external device, such as a computer. In some embodiments, metadata may be added to the live broadcast to convey more treatment information to the monitor. For example, the metadata may include sensor readings such as information related to temperatures of the inside and/or outside of the eyelid, pressure and/or force applied to the eyelid, light intensity, light frequencies, etc. Other data may also be included , such as date and time, patient name or case record number, clinician's name, or other treatment-related information.

[00315] Meibography is a technique that provides information about the morphological characteristics of the meibomian glands by observing their outline using eyelid transillumination 12, 14. One type of meibography is a non-contact infrared meibography technique that allows non-contact observation of the structure of the meibomian gland without causing discomfort to the patient. Meibography uses an infrared LED to capture images of the meibomian glands of the upper and lower eyelids. It provides a detailed view of the structure of the meibomian glands, including those glands that are hyper tortuosity or have stopped functioning as a result of blocked meibomian glands. A non-contact meibography system may include built-in imaging 160, an external monitor, and/or a recording device. Images can be obtained using an infrared radiation source. Such a meibography system may allow easy observation of meibomian gland structures in both the upper and lower eyelids without causing discomfort to the patient.

[00316] Transillumination can be used to image the meibomian glands in one of several ways. In one embodiment, the illuminating radiation can be directed at the outer surface of the eyelid at a certain angle, while the image is also obtained from the outer surface of the eyelid. This is called oblique lighting. In the second option, the radiation can be directed from behind the eyelid through the eyelid, while the image is obtained through the outer surface of the eyelid. In a third embodiment, the surface is illuminated from the front in such a way that the light source partially blocks the image being recorded, using multiple images that are averaged, added, or otherwise combined to produce a complete image. In this case, the meibomian gland is illuminated to visually examine the gland using radiation transmitted through the eyelid tissue. The eyelid can then be imaged using still or moving photography (visible light, NIR or IR, or other suitable wavelength of light) in a manner similar to that described above.

[00317] One method of observing the glands is by transilluminating the eyelid and observing with built-in imaging tools 160. For example, the radiation may be located on one side of the eyelid, and then the outline of the meibomian glands can be observed on the other side of the eyelid using the built-in imaging tools 160. This method can provide information about the morphology and physical properties of the meibomian glands. Some of the information that can be measured may include the number of glands, the degree of gland blockage, the area of meibomian gland loss, etc.

[00318] In some embodiments, eye treatment device 200 may be used to quantify the severity of dry eye by observing tear film breakup time. Tear film breakup time is a way to determine tear film stability and test for the presence of evaporative dry eye. Tear film breakup time can be useful in quantifying tear film persistence and the severity of meibomian gland dysfunction. When testing the tear film breakup time, fluorescein dye is added to the eye and the eyelid is left open. The tear film is observed using a magnifier while the patient does not blink until small dry spots form, i.e., tear film rupture occurs. Then the tear film breakup time is measured. In some embodiments, the eye treatment device 200 may include a timing element configured to record a tear film breakup time measurement. A short tear film break-up time is a sign of poor tear film quality, whereas a longer tear film break-up time indicates a more stable tear film. For example, a time >10 seconds is considered normal tear film breakup time, 5–10 seconds is considered borderline, and a time <5 seconds is considered low.

[00319] In some embodiments, eye treatment device 200 may be used to measure skin pigmentation and may be adjusted to tailor treatment parameters based on pigmentation. For example, built-in imaging 160 is configured to observe and/or record skin as radiation is reflected from the skin. Differences in reflection occur for different skin types. Using this knowledge, the eye treatment device 200 can adapt treatment parameters based on skin pigmentation indicated by the radiation reflectance measurement. In general, skin of darker colors absorbs more infrared radiation than skin of lighter colors, and thus the skin warms up faster as more radiation is converted into heat. Thus, the eye treatment device 200 may be configured to adapt treatment parameters by adjusting the radiation frequency based on pigmentation measurements.

[00320] Skin pigmentation is related to the amount of melanin in the keratinocytes of the epidermis. Varying melanin content gives rise to the wide range of observable human skin colors. When radiation hits the skin, some of the radiation is reflected by melanin, and this reflection can be used to detect the level of skin pigmentation.

[00321] In some embodiments, the eye treatment device 200 may illuminate the skin with light 211, and the built-in imaging tools 160 may observe and/or record images of the skin as the light 211 is reflected from the skin. Due to the occurrence of reflectance differences between different skin types or different skin pigments, the built-in imaging means 160 can be used to detect pigmentation.

[00322] Spectroscopy is the study of how substances absorb, transmit, or reflect radiation. Spectroscopy can be used to detect skin pigmentation. Because skin with different pigmentation has unique reflectance properties, skin pigmentation can be determined by analyzing the radiation reflectance properties.

[00323] In some embodiments, the eye treatment device 200 is configured to detect whether the eyelid is properly grasped in the correct position for treatment. In some embodiments, detection of proper eyelid grip may be accomplished through visual means, such as through the use of magnifier 1804 or built-in visualization tools 160 . In some embodiments, detection of proper eyelid grip may be accomplished using one or more contact sensors 238. Integrated imaging 160 may be used to directly visualize the eyelid and determine whether the eyelid is properly positioned for a desired treatment or procedure. In addition, the eye treatment device 200 may include an image recognition element in which an image from the built-in imaging tools 160 may be used to determine whether the eyelid is in the proper position. The contact sensors 238 may be configured to turn off the eye treatment device 200, and/or the eye treatment device 200 may signal the user or SOF to stop treatment using lights, sounds, or other notification means. For example, contact sensors 238 may be configured to provide information to a user or SOF using signals from one or more terminals. These terminals may be configured to display light of one or more colors or sound of one or more tones. The outputs may be configured to display different color schemes or sound schemes, configured to vary the intensity of light or sound, configured to provide combinations of light and sound, or otherwise configured to indicate different eyelid capture states or modes. In embodiments, sensors 238 may be configured to report eyelid capture information to other medical devices and/or communications devices.

[00324] In FIG. 26A shows embodiments of built-in imaging tools 160 used to photograph the eyelid surface and eyelid margin for the purpose of detecting obstructed meibomian glands. Several factors should be considered when evaluating the meibomian glands. These factors include the percentage of glands confined, the presence of chalazions, and the number of glands present within the eyelid margin.

[00325] Photographs can be used to score the meibomian glands (MG score), which can be proportional to the area of damage. The score can range from 0 to 3, where 0 indicates that the eyelid margin does not contain limited or missing glands, 1 indicates that less than 33% of the area of the eyelid margin is contained, 2 indicates that the area of the included eyelid margin covers from 33% to 66%, and 3 indicates that the included area covers more than 66% of the eyelid margin. The numerical values obtained for the upper and lower eyelids are added together to obtain a score from 0 to 6.

[00326] In some embodiments, built-in imaging 160 may also be used during treatment to record the extrusion of meibomian gland secretions from the glands as they are heated and compressed by the eye treatment device 200. Extruded meibomian gland secretion can be scored as follows: 0 indicates clear meibomian gland secretion, easily extruded; 1 indicates cloudy secretion of the meibomian glands, squeezed out gently; 2 indicates cloudy meibomian gland secretion that can be squeezed out with more than moderate pressure; and 3 means that the secretion of the meibomian glands cannot be squeezed out even under severe pressure. The extruded meibomian gland secretion can be used to diagnose other conditions such as blepharitis, abnormal eyelid margins, irregular eyelid margins, thickened eyelid margins, restricted glands and/or blocked glands, etc.

[00327] In some embodiments, the integrated imaging tools 160 can also use IR light to locate the meibomian glands and determine whether the glands are filled with a substance that may produce a different response to the NIR than its surrounding tissue. For example, the use of a sophisticated high-resolution NIR camera may be sufficient to distinguish tissue areas from glandular areas. The wavelength and optics used for the NIR camera should be selected to provide suitable imaging of the meibomian glands and can be optimized experimentally. Additionally, it may be advantageous to digitally process the resulting images, increasing the level of contrast and/or assigning colors to differentiate between the NIR responses of different tissues.

[00328] Image enhancement techniques are widely used in many image processing applications where the subjective quality of images is important to human interpretation. Contrast is an important factor in any subjective assessment of image quality. Contrast is created by the difference in luminosity when reflected from two adjacent surfaces. In other words, contrast is the difference in visual properties that makes an object distinguishable from other objects and the background. In visual perception, contrast is determined by the difference in color and brightness of an object relative to other objects. To perform contrast enhancement, many algorithms have been developed and applied to image processing problems. One of them is the stretching algorithm, which can be used to increase the contrast of the image and also to increase the illumination.

[00329] When the eyelid is everted for observation, it has a curved surface. When taking an image of a curved surface, some areas are in focus while other parts are out of focus. One possibility is to physically smooth the crooked surface of the eyelid. Another possibility is to use different photography techniques for curved surfaces. A clear, flat piece such as glass can be used to physically smooth the eyelid. After inversion of the eyelid, this transparent flat element can be pressed against the surface of the eyelid to smooth it in front of the camera. One way to capture images of the curved surfaces of everted eyelids is through focus stacking. Focus stacking is a digital imaging technique in which multiple images taken at different focal lengths are combined to produce a resulting image with a depth of field (DOF) greater than that of any of the individual original images. The starting point for focus stacking is a series of images captured at different focusing depths. In each image, different areas of the everted eyelid will be in focus. Although none of these images contains a sample that is completely in focus, together they contain all the necessary data to generate an image in which all parts of the eyelid are in focus. The in-focus areas of each image can be detected automatically, for example using edge detection techniques or Fourier analysis, or they can be selected manually. The in-focus areas are then blended together to generate the final eyelid image.

[00330] A common technique for interpreting images as part of the medical diagnostic process is visual interpretation. Visual interpretation makes the process dependent on the observer. Human visual perception of images depends on a small set of image characteristics: brightness, contrast, sharpness, saturation and dynamics. To increase the suitability of images for reading and reduce the influence of factors on the extraction and perception of information, the quality of images is increased. The term "image enhancement" refers to a technique for enhancing or modifying digital images so that the resulting image is better suited to a particular application than the original image. During the image enhancement process, one or more attributes of the image are modified. The set of modified attributes, the modification method, and the range of possible attribute values are specific to a specific task. One technique for improving image quality is obtaining High Dynamic Range (HDR) images. HDR imaging techniques compensate for the loss of detail by taking many images at different exposure levels and stitching them together to create an image that presents more detail in both dark and light areas. Another technique for improving image quality is pseudocoloring. The purpose of pseudocoloring is to harness the perceptual abilities of the human visual system to extract more information from an image, such as an image of an eyelid. The term pseudocoloring, or false coloring, is used to distinguish between the way colors are assigned to monochrome images through a process associated with natural color images. The process of pseudocoloring can greatly enhance the ability to detect subtle features, structures, and patterns in an image by providing image details that would otherwise not be noticed.

[00331] In FIG. 26B shows one embodiment of an inner eyelid liner 300 that allows viewing of the inside of the eyelid 14 and visibility of the meibomian glands from behind the eyelid 14. In some embodiments, the reflective surface of the fixed inner eyelid liner 300 may also be configured to view the inside of the eyelid. 14 using visualization tools 160. In some embodiments, observing the inner surface of the eyelid 14 includes candling the eyelid 14 and the meibomian glands. The image converter 155 provides the ability to view the inside of the eyelid 14 and to view the meibomian glands from behind the eyelid 14.

[00332] Illumination energy 170, which may be visible or infrared radiation, for example, passes through the eyelid 14 and thus through the meibomian glands 18, where it is reflected from the reflective surface of the stationary eyelid liner 300, and ultimately exits over the edge of the 14a century. Thus, the reflective surface allows the translucent image 190 of the inside of the eyelid 14 to be viewed by direct imaging or by a magnifying element or camera, collectively shown as an imaging device or imaging means 160, without the need to evert the eyelid 14. FIG. 2F is a front view of the embodiment shown in FIG. 26B, which shows transillumination images of 190 meibomian glands.

[00333] Some medical devices can carry bacteria, which can lead to infections or microbiological cross-contamination. The risk of infections may be reduced by antibacterial coatings of eye protection devices 200, such as antibiotics or silver particles. In some embodiments, the ocular treatment device 200 and/or the sterile disposable component 260 comprise one or more antibacterial coatings to prevent microbiological cross-contamination or the spread of bacteria.

[00334] In some embodiments, the sterile disposable component 260 is used to treat both eyes of a patient. Between treating different eyes, the sterile disposable component 260 should be treated with a disinfectant to prevent cross-microbiological contamination of the eyes. Wiping the sterile disposable component 260 between treatments of different eyes also clears it of any fluid or eyelid secretions from the sterile disposable component 260.

[00335] In some embodiments, the device includes a capacitive sensor or contact sensor 238 or other proximity sensor for detecting the position of the eye treatment device 200 relative to the eyeball 20 or eyelid 14 of the patient. In some embodiments, the contact sensor 238 may include one or more electrodes configured to detect capacitance and/or a change in capacitance when the contact sensor 238 touches the eyeball 20 or eyelid 14. In some embodiments, the contact sensor 238 may include microswitches or force or pressure contact sensors 238, all of which generate a change in signal characteristics when it touches the eyeball 20 or the skin of the eyelid 14. Thus, the contact sensors 238 can be used to assist in determining the placement of the eye treatment device 200.

[00336] To treat the inside of the eyelid, the inner eyelid pad 300 must be in contact with the inner surface of the eyelid. To determine this, some embodiments of the eye treatment device 200 include a capacitive sensor or contact sensor 238 for detecting whether the inner eyelid pad 300 is touching the inside of the eyelid or the eyeball. If the contact sensor 238 detects the eyeball or is too close to the eyeball, the eye treatment device 200 may transmit a signal to the user to pull further outward toward the eyelid. If the contact sensor 238 detects the contact of the eyelid, the eye treatment device 200 is in the correct position for treatment.

[00337] In some such embodiments, the control device is programmed to prevent activation of the eye treatment device 200 until the control device detects, through signals from the contact sensors 238, that the eye treatment device 200 is correctly positioned adjacent to the inside of the eyelid. . Additionally, in some embodiments, the control device is programmed to shut off power if signals received from the contact sensors 238 indicate that the eye treatment device 200 is no longer properly positioned against the eyelid.

[00338] To insert the fixed inner eyelid liner 300 behind the eyelid, many people pull on the eyelashes to lift the eyelid away from the eyeball for insertion of the inner eyelid liner 300. In many cases, this method stretches the eyelids and causes pain.

[00339] In some embodiments, a suction device may be attached to the outer surface of the eyelid, configured to pull the eyelid upward to make room for the inner eyelid pad 300. After placing the inner eyelid pad 300, the suction device can be separated and removed. For example, lifting the eyelid with a suction device may include: placing the suction portion of the suction device on the outer eyelid, creating suction to come into contact with the skin, pulling the eyelid away from the eyeball, and, after inserting the inner eyelid pad 300 behind the eyelid, stopping the suction and removing suction device.

[00340] In some embodiments, a retractor device comprising a curved or hook-shaped tip can slide behind the eyelid and pull the eyelid away from the eyeball to provide space for the inner eyelid liner 300. Once the inner eyelid pad 300 is in place, the retraction device can be removed.

[00341] In some embodiments, the sterile disposable component 260 or inner eyelid liner 300 may include a lifting element, such as a curved tip, hook, or other similar element, to lift the eyelid away from the eyeball. The lifting element may be built into the structure of the inner eyelid liner 300, or may be an additional part. Lifting the eyelid with the lifting device may include: sliding the lifting member on the distal end of the lifting device behind the eyelid, lifting the eyelid away from the eyeball, and, after inserting the inner eyelid liner 300 behind the eyelid, withdrawing the lifting device.

[00342] In some embodiments, the sterile disposable eyelid component 260 or inner eyelid liner 300 may include a light source for viewing the eyelid, such as for transillumination or meibography purposes. For transillumination, for example, a lighting element on a sterile disposable component may illuminate one side of the eyelid, such as the inside of the eyelid, to allow the user to view the glands within the eyelid. In some embodiments, infrared light is projected onto or through the everted eyelid and an IR sensitive camera is used to view the meibomian glands. For meibography, the sterile disposable component 260 may contain an infrared LED light source that illuminates the eyelid so that the camera receives an image. Meibography provides a view of all meibomian glands in the eyelid. In some embodiments, the light source emits blue or violet light in the range of 400-450 nm to reduce and/or eliminate bacteria.

[00343] In FIG. 27 shows one embodiment of a reflective inner eyelid liner 300 that can be positioned between the eyelid 14 and the eyeball 20 to protect the sensitive anatomy of the eye system 10 to prevent radiation from contacting the eye. The inner eyelid pad 300 is configured to receive light energy transmitted through the eyelid 14 and reflect it back onto the inner surface of the eyelid for heating.

[00344] The reflective inner eyelid pad 300 may include a set of temperature sensors 310 positioned toward the inner portion of the eyelid. These sensors may be discrete elements (e.g., very fine wire thermocouples or miniature thermistors) embedded or located in the inner eyelid liner 300, or they may be thermocouples made by depositing thin films of appropriate metals onto the interlayers of the inner liner 300 for the century.

[00345] To prevent the reflective inner eyelid pad 300 from heating the sensors, the energy reflective surface includes sensor windows for passage of the sensors and direct contact with the inner surface of the eyelid.

[00346] In some embodiments, the reflective inner eyelid liner 300 may act as a mirror to enable viewing of the inside of the eyelid 14 through imaging and transillumination of the meibomian glands from behind the eyelid. In some embodiments, radiation reflected from the reflective surface of the inner eyelid liner 300 may be used to illuminate the eyelid and meibomian glands.

[00347] In FIG. 27 also shows a portion of the sterile disposable component 260 having an inner eyelid liner 300 that may include an energy-absorbing facial surface 302 for heating the inside of the eyelid. The energy-absorbing face surface 302 may include a light source for heating. In some embodiments, the light source may be located on the inner eyelid pad 300 and directed toward the inside of the eyelid to heat the glands. For example, the light source may emit wavelengths in the range from about 500 nm to about 600 nm, for example, to achieve maximum absorption of light rays into tissue.

[00348] In some embodiments, the energy-absorbing facial surface 302 may include an optical waveguide and/or other refractive elements adapted to direct thermal radiation toward the inner eyelid pad 300 and illuminate the interior of the eyelid with that radiation to heat the meibomian glands behind the eyelid.

[00349] In some embodiments, the meibomian glands may be inflamed or dysfunctional, so it may be desirable to obtain a sample of meibomian gland secretions for analysis. For example, the meibomian glands may become inflamed due to the production of meibomian gland secretions with increased levels of essential omega-6 fatty acids. Additionally and/or alternatively, bacteria may reside in the meibomian glands and cause inflammation. In these cases, the eye treatment device 200 or the sterile disposable component 260 may include a sample receiving portion configured to receive a sample of meibomian gland secretion when extruded. For example, the sample housing portion may be a meibomian gland secretion reservoir in the sterile disposable component 260 that receives meibomian gland secretion. In some embodiments, there may be multiple sample housing portions, such as one for each eyelid. Once obtained, a sample of meibomian gland secretion can be analyzed. In some embodiments, the assay may include contacting meibomian gland secretions with a color-sensitive marker in which color is used to indicate the presence of bacteria. If bacteria are present, the SOF may prescribe a treatment plan. Additionally and/or alternatively, a camera may be useful in obtaining a sample of meibomian gland secretions. For example, a camera may observe the meibomian gland secretion as it is extruded by capturing a video image or images to document the collection of the meibomian gland secretion sample.

[00350] Eyes and eyelids can come in a variety of sizes for adults and children. To accommodate this possibility, the disposable eyelid liner 300 can be configured in a variety of sizes. For example, there may be a child size, a small adult size, a medium adult size, and a large adult size.

[00351] In FIG. 28A and 28B show another embodiment of an eye treatment device 200. In some embodiments, both the eye treatment device 200 and the sterile disposable component 260 can be rotated 180 degrees to treat the lower eyelid and upper eyelid. In addition, all controls of the eye treatment device 200 can also be rotated so that the controls are reversed when treating the upper eyelid. This may be a problem for some users. As shown in FIG. 28A and 28B, one option to avoid this potential problem is to rotate the sterile disposable component 260 180 degrees while the hand instrument 1800 remains stationary so that the eye treatment device 200 is in one position while the sterile disposable component 260 may be positioned in two positions.

[00352] In some embodiments, it may be necessary to heat or heat the meibomian glands without compressing the eyelid. For example, the eye treatment device 200 may be configured as a non-contact infrared heating device that uses IR LEDs to heat the meibomian glands in the eyelid without compressing the eyelid.

[00353] To summarize the present disclosure, certain aspects, advantages and features have been described herein. It should be understood that all of these advantages are not necessarily achieved in accordance with every particular embodiment. Thus, the described devices and methods may be implemented or implemented in such a way as to achieve or optimize one benefit or group of benefits described herein, without the need to achieve other benefits that may be considered or proposed herein.

[00354] Although the present invention has been described in connection with what are currently considered to be practical embodiments, those skilled in the art will appreciate that various modifications and changes may be made without departing from the scope of the present invention. It will also be appreciated by those skilled in the art that parts mixed with one embodiment are interchangeable with other embodiments; one or more parts from the illustrated embodiment may be included in other depicted embodiments in any combination. For example, any of the various components described herein and/or depicted in the figures may be combined, exchanged, or omitted from other embodiments. With respect to the use of substantially any plural and/or singular terms herein, those skilled in the art may translate plural into singular and/or singular into plural according to context and/or application. Various permutations of the singular and/or plural may be stated explicitly herein for the sake of clarity.

[00355] Although certain exemplary embodiments have been described in the present invention, it should be understood that the present invention is not limited to the described embodiments, but rather is intended to cover various modifications and equivalent arrangements included within the scope of the appended claims, as well as their equivalents .

Claims (21)

1. A system for treating the eye of a mammal that has an eyelid, comprising: portable device having: tool body with fastening latch and electrical connecting pin; a control switch that controls a power converter comprising a device emitting light energy at wavelengths including a first wavelength selected to pass through the eyelid and a second wavelength selected to be absorbed by the eyelid for heating; And an actuator controlled by a compression control button for moving the movable housing away from the tool body, the movable housing being configured to hold and deliver light energy through the movable housing; an attached component having: a fastening tongue configured to be connected to a fastening latch of the tool body; an outer eyelid seal configured to be placed in front of or on the outer surface of the eyelid, wherein the outer eyelid seal is made of a transparent material that transmits light energy delivered by the movable housing; And a backplate configured to be positioned behind or on an inner surface of the eyelid, the backplate being made of or covered with an energy reflective material configured to receive a first wavelength of light energy transmitted through the eyelid and reflect it back into the eyelid; wherein, when the eyelid is positioned between the outer eyelid pad and the backplate, light energy from the energy converter heats the target tissue region of the eyelid sufficiently to melt meibomian gland secretions within the region of meibomian glands located within or adjacent to the target tissue region, and wherein, as the movable housing moves away from the body of the instrument, the movable housing forces the outer eyelid pad to advance toward the back plate and compress the eyelid to squeeze out the meibomian glands. 2. The system according to claim 1, in which the energy converter is further configured to provide light energy at a third wavelength selected for bacteriological treatment. 3. The system of claim 1, further comprising an imaging device for viewing the eyelid during treatment. 4. The system of claim 1, wherein the power converter comprises at least one of an LED, a laser, an incandescent lamp, a xenon lamp, a halogen lamp, a fluorescent lamp, a high intensity discharge lamp, and a gas discharge lamp. 5. The system of claim 1, further comprising one or more components selected from the group consisting of: a display or instrument panel configured to display the status of the device; a temperature measuring device configured to measure various temperatures of the eyelid, including temperatures of the inner and/or outer surfaces of the eyelid; data logger; voice recorder; a battery configured to provide power to the components of the device; battery charging means; control devices; printed circuit board; and communication circuits between the back plate and the power converter. 6. The system of claim 2, wherein the actuator is at least one of a lever, a button, a wheel, a slide and a switch. 7. The system according to claim 1, in which the temperature sensor is configured to provide information about the temperature of the eyelid, and the energy converter is connected to the temperature sensor and is configured to detection when the temperature of the eyelid reaches the first set threshold temperature, decreasing the intensity of light emitted by the energy converter from a first intensity to a second intensity when the eyelid temperature reaches a first predetermined threshold temperature, detecting when the eye temperature reaches a second predetermined threshold temperature selected based on patient safety and ongoing therapeutic efficacy, and allowing the light intensity to increase to a first intensity when a second predetermined threshold temperature is detected.

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