Systems and methods for treating eye conditions

Abstract

Systems, methods, and devices for treating eyelids, meibomian glands, ducts, and surrounding tissue are described herein. In some embodiments, an eye treatment device is disclosed, the eye treatment device comprising a scleral shield positionable near the inner surface of the eyelid and an energy converter positionable on the outside of the eyelid, the scleral shield being made of or coated with an energy absorbing material activated by light energy, the energy converter being configured to provide one or more wavelengths of light energy, including a first wavelength selected to heat the energy absorbing material. Wherein, when the eyelid is positioned between the energy converter and the scleral shield, the heated energy absorbing material from the energy converter and the scleral shield conducts heat to a target tissue region sufficient to melt meibum in a meibomian gland located within or adjacent to the target tissue region.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims the benefit of U.S. Provisional Application No. 62 / 776,333, filed December 6, 2018, which is incorporated herein by reference. Priority is claimed to the above filing date. Background Art

[0003] The present disclosure relates to medical devices and methods of use thereof. More specifically, the present disclosure relates to systems, methods, and apparatus for diagnosing and treating conditions of the eye, such as meibomian gland dysfunction and blepharitis, which typically involve the eyelids, meibomian glands, ducts, orifices, and surrounding tissues.

[0004] Meibomian gland dysfunction (MGD) is considered the most common cause of evaporative dry eye, with studies showing prevalence rates in the general population ranging from 20% to 60%. MGD is associated with the inability of the meibomian glands to produce adequate amounts of normal secretions, called meibum. Meibum is an essential, lipid-rich component of the healthy tear film. When there is not enough meibum in the tear film, the film evaporates easily, resulting in evaporative dry eye. In some patients, the viscosity and melting point of the meibum may increase, creating thickened meibum that does not flow out of the glands as easily. Additionally, the channels or ducts within the meibomian glands may become hyperkeratinized, creating excess cellular debris and, over time, causing the glands to become clogged. Once a gland becomes chronically clogged (clotted), the gland may atrophy and no longer be able to produce or secrete meibum.

[0005] Blepharitis is a common, chronic inflammatory condition involving the eyelids and lid margins and is often associated with MGD. Studies have shown that the prevalence of blepharitis in the general population ranges from 12% to 47%, with a higher prevalence in the elderly population. In addition to certain pathogenic factors associated with MGD, blepharitis may also be caused in part by the abundance of certain bacteria in and around the eyes and eyelids. The byproducts of the bacteria are thought to irritate the eyes, leading to further inflammation and discomfort for the patient. In addition, several common mites may exacerbate inflammation of the meibomian, or sebaceous, glands in and around the eyes. The inflammation caused by these factors may cause the meibomian gland ducts to further constrict, thereby restricting the flow of meibum from the glands and worsening the condition.

[0006] The diagnosis of meibomian gland dysfunction can be done in a variety of ways. Typical approaches include measuring the tear breakup time (TBUT), staining various ocular surfaces, and examining the meibomian glands and their secretions. A common technique for examining the glands themselves is to evert the eyelids and place a light source under the everted eyelids (on the outer surface of the eyelids) while examining the "transillumination" image of the glands produced by passing light through the eyelids. The images can be observed with the naked eye, a biological microscope, or a camera. Healthy glands are long and relatively straight in form, while dysfunctional glands may appear tortuous and swollen, and atrophic glands lack continuity between the glands and the ducts or holes. In some cases, infrared light is projected onto or through the everted eyelids, and an IR-sensitive camera is used to view the meibomian glands. The disadvantage of these transillumination techniques is that they require the eyelids to be everted, which is uncomfortable for most patients and may be difficult for clinicians to perform on certain eyelids.

[0007] Another common technique for diagnosing MGD is to apply pressure to the eyelid while visualizing the meibomian gland ducts or orifices along the lid margin, usually with a magnifying device such as a biomicroscope. Healthy glands produce a clear, oily secretion in response to applied pressure. Partially dysfunctional glands produce less oil and / or a cloudy oil. More severely dysfunctional (congealed) glands produce a pasty secretion that can only be expressed when more significant pressure is applied to the eyelid. Glands that are completely atrophied or whose orifices are blocked will not produce any oil even under high pressure.

[0008] MGD and blepharitis are chronic conditions for which effective treatments are limited. One of the most commonly recommended treatments is heat and massage (using a compress or fingertips) of the eyelid area. The stated goal of heat therapy is to heat the congealed meibomian glands where the thickened meibum resides, softening it and thereby allowing it to drain more easily through the ducts. This process is thought to unclog the ducts and thereby restore normal ductal secretion and maintain a healthier tear film. Patients are often instructed to apply a hot washcloth or other warm compress to the eyelids for five to ten minutes daily. However, the efficacy of this approach may be limited.

[0009] In-office treatments for MGD are usually limited to squeezing the affected eyelid to drain the meibum from the blocked or clotted gland. Most clinicians use their fingertips or cotton swabs to apply pressure to the outer surface of the eyelid, but sometimes they also use a cotton swab or a flat metal device (sometimes called a Mastrota paddle) on the inner eyelid while pushing against the outer eyelid to squeeze the meibum out. All of these techniques are cumbersome for the clinician and painful for most patients.

[0010] Another in-office treatment is the use of intense pulsed light (IPL) around the eye and eyelids. This treatment is said to improve dry eye symptoms over multiple sessions, but the mechanism is not clear and the equipment is expensive.

[0011] Yet another in-office treatment approach is the TearScience LipiFlow(r) system, in which a heating element is placed beneath the eyelid and an external automated controller maintains the heating element at a target temperature while applying a predetermined pattern of compression to the outer eyelid via an inflatable bladder. This system is expensive and does not allow the clinician to control the treatment to visually monitor the lid margin and meibomian gland ducts, and does not allow for varying the levels of heating and compression during the procedure in a manner that optimizes treatment outcomes. This control of the treatment by the clinician can be important and is not present in the TearScience system.

[0012] Patients can also use saline drops or artificial tears to relieve discomfort associated with dry eyes; however, this approach does not treat the dysfunctional meibomian glands and underlying inflammation. Additionally or alternatively, antibiotics may be prescribed to reduce the bacterial load in and around the eyelids. Topical and oral antibiotics may be used, including oral tetracycline derivatives, which reduce certain bacteria and provide a mild anti-inflammatory effect; however, the administration of antibiotics may result in side effects or adverse allergic reactions, and this approach is generally insufficient to provide long-term significant relief of blepharitis and MGD. Corticosteroids may be prescribed to reduce inflammation; however, long-term use of such steroids increases the risk of infection due to deleterious cortical lens changes, increased intraocular pressure, and immunosuppression.

[0013] Therefore, there is a need for improved methods and devices for diagnosing and treating meibomian gland dysfunction and blepharitis. Summary of the invention

[0014] Embodiments described herein may satisfy one or more of the needs identified above and may overcome one or more shortcomings in current treatments for MGD and blepharitis. Various implementations of systems, methods, and devices within the scope of the appended claims each have multiple aspects, no single aspect being solely responsible for the desirable properties described herein. Without limiting the scope of the appended claims, some salient features are described herein.

[0015] The present application generally relates to treatment systems, methods and devices for treating eyelids, meibomian glands, ducts and surrounding tissues. The details of one or more embodiments of the subject matter described in this specification are set forth in the accompanying drawings and the following description. Other features, embodiments and advantages will become apparent from the description, drawings, and claims.

[0016] In one aspect, a device for treating a mammalian eye having an eyelid is provided, the device comprising: an energy converter having means for emitting light energy of multiple wavelengths, the wavelengths including a first wavelength selected to pass through the eyelid and a second wavelength selected to be absorbed by the eyelid to increase temperature; a front plate positionable near an outer surface of the eyelid, the front plate being made of a transparent material that transmits the light of the wavelengths emitted by the energy converter, the front plate further comprising a sensor configured to provide information about the position of the eyelid relative to the front plate; a back plate positionable near an inner surface of the eyelid, the back plate being made of or coated with an energy reflective material, the energy reflective material being configured to receive the light energy of the first wavelength transmitted through the eyelid and reflect it back to the eyelid, the back plate further comprising a sensor configured to provide information about the position of the eyelid relative to the front plate; and wherein, when the eyelid is positioned between the front plate and the back plate, the light energy from the energy converter heats a target tissue region sufficient to melt meibum in a meibomian gland located within or adjacent to the target tissue region.

[0017] In an embodiment, the device further comprises an actuator coupled to the front plate and the rear plate, the actuator being configured to generate relative movement between the front plate and the rear plate to squeeze the eyelid to drain the meibomian gland. In an embodiment, the actuator is further configured to control the amount of light energy of the second wavelength emitted by the energy converter, thereby controlling the heating of the target tissue. In an embodiment, the actuator is at least one of a lever, a button, a wheel, a slider, and a switch.

[0018] In an embodiment, the energy converter is further configured to provide light energy at a third wavelength selected to treat bacteria. In an embodiment, the energy converter comprises at least one of: an LED, a laser, an incandescent lamp, a xenon lamp, a halogen lamp, a luminescent lamp, a high intensity discharge lamp, and a gas discharge lamp.

[0019] In an embodiment, the device further comprises a visualization device for observing the eyelid during treatment. In an embodiment, the device further comprises one or more components selected from the group consisting of: a display or dashboard configured to display the status of the device; a temperature measurement device, the temperature measurement device being configured to measure various temperatures of the eyelid, including the inner surface temperature of the eyelid and / or the outer surface temperature of the eyelid; a data logger; a voice recorder; a battery configured to power the device components; a battery charging device; a controller; a printed circuit board; and a communication circuit system between the shield and the energy converter.

[0020] In another related aspect, a method for treating an eye condition of a mammal is provided, the method comprising: positioning a shield near the inner surface of an eyelid, the shield being made of or coated with an energy absorbing material, the shield further comprising a sensor configured to provide information about the position of the eyelid relative to the shield; positioning an energy converter on the outside of the eyelid of the mammal, the energy converter being configured to provide light energy of one or more wavelengths; positioning an energy transfer surface on the outside of the eyelid, the energy transfer surface comprising a sensor configured to provide information about the position of the eyelid relative to the energy transfer surface; causing relative movement between the energy transfer surface and the shield to change the spacing relationship between the energy transfer surface and the shield; directing light energy of a first wavelength selected to heat the energy absorbing material from the energy converter toward the shield; and heating the energy absorbing material with the light energy to heat a target tissue area sufficient to melt meibum in a meibomian gland located within or adjacent to the target tissue area.

[0021] In embodiments, the method further comprises directing light energy from the energy converter at a second wavelength selected to heat a target tissue area within the eyelid toward an outer surface of the eyelid. In embodiments, the method further comprises directing light energy from the energy converter at a third wavelength selected to treat bacteria toward the eye.

[0022] In embodiments, the method further comprises compressing the eyelid between the energy delivery surface and the occluder. In embodiments, the method further comprises focusing the compression on a stye or papule to treat hordeolum. In embodiments, the method further comprises focusing the compression on a blocked gland to treat a chalazion.

[0023] In an embodiment, a safety feature electrically coupled to the energy converter prevents or interrupts the light energy from occurring if the shield and associated components are not properly attached and aligned to the device.

[0024] In an embodiment, the relative movement between the energy transfer surface and the shield comprises movement of the energy transfer surface relative to the shield. In an embodiment, the relative movement between the energy transfer surface and the shield comprises sliding movement of the energy transfer surface relative to the shield. In an embodiment, causing the relative movement between the energy transfer surface and the shield comprises actuating an actuator coupled to the energy transfer surface. In an embodiment, actuating the actuator comprises a push button. In an embodiment, causing the relative movement between the energy transfer surface and the shield comprises sliding the energy transfer surface relative to the shield.

[0025] In an embodiment, the position of the eyelid relative to the position of the shield and the energy conversion surface must be within a predetermined range within which the energy converter will emit light energy. BRIEF DESCRIPTION OF THE DRAWINGS

[0026] The above aspects and other features, aspects and advantages of the present technology will now be described with reference to the accompanying drawings in conjunction with various embodiments. However, the embodiments shown are exemplary only and are not intended to be limiting. Throughout the drawings, similar symbols generally identify similar components unless the context indicates otherwise. It should be noted that the relative dimensions of the following figures may not be drawn to scale.

[0027] Figure 1A is a cross-sectional view of a mammalian eye system 10 .

[0028] Figure 1B is a view of the underside surface of the upper and lower eyelids showing the meibomian glands with healthy, blocked, and atrophic glands.

[0029] Figure 2A is a schematic block diagram of one embodiment of an eye treatment device according to some embodiments.

[0030] Figure 2B is a schematic block diagram of another embodiment of an eye treatment device.

[0031] Figure 2C is a schematic block diagram of another embodiment of an eye treatment device having a scleral shield.

[0032] Figure 2D is a schematic block diagram of another embodiment of an ophthalmic device having a scleral occluder with an imaging element.

[0033] Figure 2E yes Figure 2D A close-up cross-sectional view of a portion of an embodiment of the present invention.

[0034] Figure 2F yes Figure 2E Front view of the embodiment shown in .

[0035] Figure 2G is similar to Figure 2D A schematic block diagram of another embodiment of an ophthalmic device.

[0036] Figure 2H is similar to Figure 2C A schematic block diagram of another embodiment of an ophthalmic device.

[0037] Figure 3A is a schematic block diagram of an embodiment of an eye diagnostic and treatment device.

[0038] Figure 3B yes Figure 3A An enlarged view of one embodiment of a scleral occluder is shown.

[0039] Figure 4A is a schematic side plan view of one embodiment of an eye treatment device.

[0040] Figure 4B yes Figure 4A Schematic front plan view of an energy converter module and an energy waveguide module included in an embodiment of an eye treatment device.

[0041] Figure 4C yes Figure 4A A schematic side plan view of the eye treatment device shown in use.

[0042] Figure 4D is a schematic side plan view of another embodiment of an eye treatment device.

[0043] Figure 4E is a perspective view of an optical element in another embodiment of an eye treatment device.

[0044] FIG. 4F to FIG. 4H yes Figure 4E Front view, side view, and cross-sectional view of a prism element. FIG. 4I to FIG. 4L yes Figure 4E Front view, cross-sectional view, side view, and perspective views of a forming lens element.

[0045] Figure 4M and Figure 4N is a theoretical graphical representation of the irradiance pattern produced by the 4E's optics.

[0046] Figure 5A is a schematic side plan view of an additional embodiment of an eye treatment device.

[0047] Figure 5B yes Figure 5A Schematic front plan view of an embodiment of an eye treatment device.

[0048] FIG. 5C to FIG. 5F are side, top, front, and perspective views of a portion of another device embodiment.

[0049] Figure 5G and Figure 5H 5C to Fig. 5F A theoretical graphical representation of the irradiance pattern produced by the optical components.

[0050] Figure 6is a schematic side plan view of an embodiment of an eye treatment system including an eye treatment device and a scleral shield.

[0051] 7A to 7H are schematic front plan and side views of various embodiments of scleral shields.

[0052] Figure 8 is a schematic side plan view of another embodiment of an eye treatment device.

[0053] Fig. 9 is a schematic side plan view of another embodiment of an eye treatment device including one or more cooling mechanisms.

[0054] Fig.10 is a schematic side plan view of another embodiment of an eye treatment device including one or more safety sensors.

[0055] Fig.11A is a schematic side plan view of another embodiment of an eye treatment device.

[0056] Fig. 11B is a schematic side plan view of another embodiment of an eye treatment device.

[0057] Fig.12 is a schematic side plan view of another embodiment of an eye treatment device including a vibrating device.

[0058] Fig.13 is a schematic diagram of one embodiment of an eye treatment system as used by an individual.

[0059] Fig.14A is a schematic side plan view of an embodiment of an eye treatment system.

[0060] Fig. 14B yes Fig.14A Schematic front plan view of a portion of an eye treatment system embodiment.

[0061] Fig.15A is a schematic side view of an embodiment of an eye treatment instrument system.

[0062] Fig. 15B It is along Fig.15A A front cross-sectional view of the illustrated embodiment is taken along line AA.

[0063] Fig. 15C yes Fig.15A Front view of the embodiment shown in .

[0064] Fig.15D It is along Fig.15A The embodiment shown is a side cross-sectional view taken along line BB.

[0065] FIG. 16A to FIG. 16O Shown is a unique configuration of the system's energy delivery surface, scleral shield, and support arm that defines an orifice that allows viewing of one or both lid margins during application of heat and compression to the treated eyelid portion.

[0066] FIG. 17A to FIG. 17C An embodiment of an energy converter module in combination with an energy waveguide module and an energy transfer surface is shown.

[0067] Fig.17D Shown for FIG. 17A to FIG. 17C Embodiment, graphical representation of irradiance distribution of infrared light transmitted through an eyelid.

[0068] FIG. 17E to FIG. 17F Depicted is an element having an energy transmitting surface with a coating.

[0069] Figure 17G is a graphical representation of the irradiance distribution of infrared light transmitted through an eyelid for an embodiment having a certain coating on a portion of the energy transmitting surface.

[0070] Fig.17H The irradiance distribution of lime light on the outer surface of the eyelid is for an embodiment having a certain coating on a portion of the energy transmitting surface.

[0071] Fig.18A and Fig.18B are front and side views of another embodiment of an eye treatment device.

[0072] Fig.19 FIG. 1 is a diagram showing an embodiment of a front panel of a disposable article.

[0073] Fig. 20 One embodiment of an eye treatment device display is shown showing details of the melting time.

[0074] Fig.21A and Fig. 21B is a diagram illustrating one embodiment of an eye treatment device with a movable light pipe.

[0075] Fig. 22 Further features of the disposable article are shown, including front panel design elements.

[0076] Fig.23 yes Fig. 22 Exploded view of disposable items.

[0077] Fig.24 Further features of the disposable are shown, including thermal isolation of the back panel sensor.

[0078] Fig.25A graph showing pulsed or interleaved operation of the light source and camera.

[0079] Fig.26A and Fig.26B An embodiment of a camera for viewing and / or photographing the surface and lid margin of an eyelid to detect blocked meibomian glands is shown.

[0080] Fig. 27 Another embodiment of a back plate having a heating portion to warm the eyelid is shown.

[0081] Fig.28A and Fig.28B are front and side views of another embodiment of an eye treatment device in which a disposable article can be rotated between treating the upper eyelid and the lower eyelid. DETAILED DESCRIPTION

[0082] In the following detailed description, reference is made to the drawings that form a part of the present disclosure. In the drawings, similar symbols generally identify similar components unless the context indicates otherwise. The illustrative embodiments described in the detailed description, drawings, and claims are not meant to be restrictive. Other embodiments may be used and other changes may be made without departing from the spirit or scope of the subject matter presented herein. It will be readily understood that the various aspects of the present disclosure as generally described herein and shown in the drawings may be arranged, replaced, combined, and designed in a variety of configurations, all of which are expressly contemplated in the present disclosure and form a part of the present disclosure.

[0083] The terms used herein are only used for the purpose of describing specific embodiments and are not intended to limit this disclosure. It will be understood by those skilled in the art that if it is intended to have a specific number of claim elements, such intention will be clearly stated in the claims, and if there is no such statement, such intention will not exist. For example, as used herein, the singular forms "a / an" and "the" are also intended to include plural forms unless the context clearly indicates otherwise. As used herein, the term "and / or" includes any and all possible combinations of one or more items in the associated enumeration items. It will be further understood that the terms "comprises / comprising", "having" and "includes / including" are used in this specification to indicate the presence of stated features, integers, elements and / or parts, but do not exclude the presence or addition of one or more other features, integers, steps, operations, elements, parts and / or their groups. When there is a statement such as "at least one" before the list of elements, it modifies the entire list of elements rather than the individual elements in the list of elements.

[0084] To help describe the devices and methods described herein, some relational and directional terms are used. As used herein, "connected" and "coupled" and variations thereof include direct connections, such as being formed in conjunction with, glued to, or otherwise directly attached to, on, within, etc., another element; and indirect connections, in which one or more elements are disposed between connected elements. "Connected" and "coupled" may refer to permanent or non-permanent (i.e., removable) connections.

[0085] As used herein, "fixing" and variations thereof include methods of directly fixing an element to another element (such as gluing, screwing or otherwise fastening directly to, on, in, etc. another element); and indirect means of fixing two elements together, wherein one or more elements are arranged between the elements being fixed.

[0086] "Proximal" and "distal" are relational terms used herein to describe locations from the perspective of a medical professional treating a patient. For example, the term "proximal" refers to a location that is closer to a medical professional during treatment, as compared to "distal," which is closer to the patient. For example, the distal end of a device disclosed herein is opposite the proximal end of the same device, and the distal end of a device generally includes, for example, the end that is configured to rest on an eyelid of a patient.

[0087] "Transducer" is a term used herein to describe an element that receives 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.

[0088] As used herein, "light" refers not only to energy in the visible light spectrum, but also energy in the infrared and ultraviolet portions of the electromagnetic energy spectrum.

[0089] As used herein, "waveguide" refers to any device that affects the propagation, distribution, or trajectory of electromagnetic energy, such as light, ultrasound energy, and radio frequency energy. As defined herein, optical elements (such as diffractors, refractors, diffusers, etc.) are included in this broad definition of waveguide.

[0090] "Optical path length" is used herein to describe the length of a path (eg, within a tissue segment) that energy travels.

[0091] Embodiments disclosed herein relate to ophthalmic devices, systems, and methods. The devices, systems, and methods disclosed herein can be used to treat meibomian glands, ducts, orifices, and surrounding tissues, and are particularly directed to the treatment of MGD, blepharitis, and conditions that have a physiological relationship to MGD and blepharitis, such as evaporative dry eye. Figure 1A is a cross-sectional view of a mammalian eye system 10, which includes an eyeball 20 and surrounding eyelid anatomy. As set forth in this disclosure and as Figure 1A As shown, the "central eye axis" 30 of the eye is the central axis extending through the center of the cornea 22, iris 24, pupil 25, lens 26 and vitreous body 28 of the eyeball 20. The eye system 10 includes an upper eyelid 12, a lower eyelid 14, and eyelashes 16. Within the tissue of each eyelid 12, 14, there are meibomian glands 18, each of which has a hole or duct 19. In a healthy eye system 10, the meibomian glands 18 secrete a substance called meibum from the ducts 19, which is mainly composed of lipids and proteins. Meibum forms part of the tear film that covers the surface of the eyeball 20.

[0092] Figure 1B is a view of the inner eyelid, showing the meibomian glands with healthy, blocked, and atrophic glands. Chronic obstruction of the glands is associated with MGD and some forms of blepharitis, and may result in duct obstruction and / or gland atrophy. Inflammation associated with MGD or blepharitis may in turn result in further contraction of the gland duct 19, resulting in reduced meibomian gland secretions and a corresponding reduction in the amount of lipids in the tear film. Tear films with reduced lipid content may evaporate rapidly and lead to evaporative dry eyes. A reduction in the tear film may also be associated with increased levels of bacteria in and around the eye. Such bacteria may aggravate inflammation by themselves or through certain byproducts that irritate the eye. It is believed that permanent gland atrophy can be avoided by regularly cleaning chronically blocked glands.

[0093] Another factor thought to contribute to blepharitis is the presence of Demodex folliculorum and Demodex sebaceum, which are common in most people and reported to be present in greater numbers in individuals with blepharitis. These mites may live in the follicles of the eyelashes and eyebrows, as well as in the meibomian and sebaceous glands. Their presence may cause inflammation in some individuals, but it is also thought that the mites may harbor certain bacteria that are released into the eyelid area during their life cycle, causing further inflammation.

[0094] Figure 2A is a schematic block diagram of an eye treatment device 100 according to various embodiments. Figure 2A As shown, the eye treatment device 100 depicted includes a power supply module 110, an energy converter module 120, an energy waveguide module 130, and an energy transmission surface 140 (also referred to as a compression element). In some embodiments, the 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.

[0095] The power module 110 of various embodiments provides energy to the energy converter module 120. The power module 110 may include any structure configured to deliver power to one or more other components of the eye treatment device 100. In some embodiments, the power 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 transfer mechanism (such as a flexible cord, a socket, or a plug configured to receive AC or DC power from an external source).

[0096] The 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, these energy converters emit photon energy, acoustic energy, radio frequency energy, electrical energy, magnetic energy, electromagnetic energy, vibrational energy, infrared energy, or ultrasonic energy. In some embodiments, the energy converter module 120 generates multiple types of energy simultaneously or in a predetermined sequence.

[0097] The energy waveguide module 130 includes one or more structures configured to control or focus the direction of energy emission from the energy converter. For example, the energy waveguide module 130 may include one or more reflectors, refractors, diffractors, or diffusers (described in more detail below) configured to focus photon energy to a desired area; or other structures for configuring and directing energy emission, such as an ultrasonic horn or an optical fiber.

[0098] Figure 2A The eye treatment device 100 can further advantageously include an energy transfer surface 140 that is configured to further direct the energy generated by the energy converter module 120 to a desired area. For example, the energy transfer surface 140 can include one or more lenses configured to focus the energy generated by the energy converter module 120.

[0099] In some embodiments, energy waveguide module 130 and energy transfer surface 140 may also prevent or limit energy generated by energy converter module 120 from being transferred to specific areas of the eye. Energy transfer surface 140 may include areas that are substantially opaque or non-transmissive to energy generated by energy converter module 120; and areas that are semi-transparent or transmissive to energy generated by energy converter module 120. These modules of eye treatment device 100 are described in further detail below with respect to other embodiments of the present disclosure and may include other components.

[0100] Figure 2B is a schematic block diagram of an eye treatment device 100 according to various embodiments. Figure 2B Similar to Figure 2AThe eye treatment device 100 includes a power supply module 110, an energy converter module 120, an optional energy waveguide module 130, and an energy transmission surface 140. The energy transmission surface 140 can be substantially solid, or can include elements that are spaced apart from the energy transmission surface 140 or other portions of the eye treatment device 100. For example, the energy transmission surface 140 can include an extended element positioned at a distance from the solid portion of the energy transmission surface 140. For example, in Figure 2B In the embodiment of the present invention, the extension element 143 is described as a mesh structure spaced apart from the main portion of the energy transmission surface 140 (if present). The extension 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 transmission surface 140 (if present) or the energy waveguide (if present) or the energy converter module and the eyelid surface 12, 14. For example, the gap created by the extension element 143 can be beneficial in providing a path for forced air cooling of the eyelid. In addition, pressing the extension element 143 against the eyelid surface can reduce the optical path length for heating the eyelid 12, 14 and / or the target component within the eyelid. Reducing the optical path length can be beneficial for heating tissue because it improves radiation throughput, reduces scattering, reduces refractive index matching, and increases flux. The extension element 143 can be made of a low thermal mass material, such as a thin wire or plastic mesh or a thin metal or plastic surface with holes, and can be configured to conform to the shape of the eyelid when pressure is applied to the surface of the eyelid. In one embodiment, extension element 143 can be configured so that when it is pressed against the upper and lower eyelids, it can evenly or unevenly distribute the applied pressure across the combined upper and lower eyelid outer surfaces. For example, in one embodiment, extension element 143 can apply less pressure to central eye axis 30 and more pressure elsewhere, which may be desirable in situations where it may be believed that repeated pressure on the eyelids at the central eye axis increases the likelihood of inducing complications such as keratoconus. In other embodiments, extension element 143 can be actively heated or cooled.

[0101] Figure 2C 1 is a schematic block diagram of another embodiment of an eye treatment device 100 having a power supply module 110, an energy converter module 120, an optional energy waveguide module 130, an energy transmission surface 140, and a scleral shield 300 (also referred to as a back plate). In this embodiment, one or more eyelids 12, 14 are positioned between the energy transmission surface 140 and the scleral shield 300.

[0102] The 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, these energy converters emit photon energy, acoustic energy, radio frequency energy, electrical energy, magnetic energy, electromagnetic energy, vibration energy, infrared energy, or ultrasonic energy. In some embodiments, the energy converter module 120 generates multiple types of energy simultaneously or in a predetermined sequence. An optional energy waveguide module may be included to control or focus the direction of energy emission from the energy converter, as described above.

[0103] Figure 2C The eye treatment device 100 may further advantageously include an energy transfer surface 140 configured to further direct the energy generated by the energy converter module 120 to a desired area. The energy transfer surface 140 may include one or more lenses configured to focus the energy generated by the energy converter module 120. The energy transfer surface 140 (and / or Figure 2B The extension element 143 shown can be moved along the movement path 145 to adjust certain energy transmission characteristics (such as focus) and / or contact the surface of the eyelid 12, 14 and / or apply 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 relative to other parts of the ocular treatment device 100, the eyelid 12, 14 can be compressed, thereby reducing the optical path length for heating the eyelid 12, 14 and / or the target component within the eyelid. Reducing the optical path length is beneficial for heating tissue because it improves radiation throughput, reduces scattering, reduces refractive index matching, and increases flux. The eyelid can be compressed by compressing or pushing the eyelid against the compression element with the back plate 300. Alternatively, the eyelid can be compressed by compressing or pushing the eyelid against the back plate 300 with the compression element.

[0104] In some embodiments, the energy converter module 120 can generate multiple types of energy simultaneously, such as photon energy, acoustic energy, radio frequency energy, electrical energy, magnetic energy, electromagnetic energy, vibration energy, infrared energy, or ultrasonic energy. For example, in a mode further described in detail below, a first energy can heat the outer surface of the eyelid, while a second energy can penetrate deeper into the eyelid tissue and / or interact with the scleral occluder.

[0105] Similar to Figure 2C , Figure 2D is a schematic block diagram of another embodiment of an eye treatment device 100 having a power supply module 110, an energy converter module 120, an optional energy waveguide module 130, an energy transmission surface 140, and a scleral shield 300. In some embodiments, the scleral shield 300 may further include an image converter 155 integrated into the scleral shield 300. Figure 2E A close-up cross-sectional view of the image converter 155 embedded in the scleral shield 300 is shown, with the eyelid 14 adjacent to the image converter 155. In the illustrated embodiment, the image converter 155 is reflective. For example, the illumination energy 170 (which may be visible light or infrared light) passes through the eyelid 14, and therefore through the meibomian gland 18, and then reflects off the reflective surface 180 along the optical path 175 through the energy-transmissive material 185, ultimately exiting the image converter 155 above the eyelid margin 14a. It should be appreciated that the resulting image emerging from the image converter 155 will be a shadow image or a transilluminated image of the portion of the eyelid 14 adjacent to the image converter 155 and illuminated by the illumination energy 170. In this manner, the image converter 155 allows the transilluminated image 190 of the inside of the eyelid 14 to be viewed under direct visualization or with the aid of a magnifying element or camera (collectively shown as a visualization device or visualization means 160) without everting the eyelid. Figure 2F yes Figure 2E A front view of the same embodiment is shown, showing a transilluminated image 190 of the meibomian glands.

[0106] The image converter 155 may include a set of mirrored surfaces or a prism with a reflective surface. Alternatively, the image converter may include a light bending element, such as a light pipe, a fiber bundle, an image sensor, or some combination thereof. It should be appreciated that various desired optical properties may be incorporated into the image converter 155, such as image projection, angulation, or magnification. These properties may be obtained, for example, by bending the reflective surface 180, by shaping the surface of the transmissive material 185, and / or by changing the refractive index, by changing the density and distribution of fiber elements in the fiber bundle, or by some combination thereof. In embodiments where the image converter 155 includes an image sensor, such a sensor may be of the CCD type, of the CMOS type, a luminescent concentrator (such as has been fabricated at the Johannes Kepler University in Linz, Austria), or any type of sensor that can capture transillumination data and convert it into visual, optical, or electronic information.

[0107] In some embodiments, visualization of the lid margin 14a provides significant benefits during diagnosis and treatment of the eyelid 14. For example, as described above, positioning the eyelid 14 between the energy transmission surface 140 and the scleral shield 300 with the image converter 155 allows visualization of the transilluminated image of the eyelid and meibomian glands. Figure 1B As shown, the morphology of healthy, obstructed, and atrophic glands differs significantly, allowing the status of each gland to be diagnosed by viewing the transilluminated images of the glands. Figure 2DThe glandular status can also be evaluated without transillumination by observing the lid margin 14a while moving the energy transmission surface 140 along the movement path 145 to press against the eyelid 14. When the eyelid 14 is compressed, the lid margin 14a is observed, and the glandular status is evaluated by the quality and amount of secretions from the duct 19.

[0108] If treatment is required after diagnosis, ocular treatment device 100 can be repositioned along eyelid 14 so that the majority of the diseased gland is positioned between energy transmission surface 140 and scleral shield 300. Once ideally positioned, energy transmission surface 140 can be moved along movement path 145 to contact the surface of eyelid 12, 14 and / or continue to move toward scleral shield 300 and apply pressure to eyelid 12, 14.

[0109] See again Figure 2D , an optional coupling medium 195 may be positioned between the eyelids 12, 14 and the energy transmission surface 140. The coupling medium 195 may be a fluid, gel, cream, etc., and may contain an agent such as glycerin, which may increase the efficiency of light transmission into the eyelids and target tissue by reducing light scattering and increasing light transmission by reducing the refractive index mismatch between the eyelids 12, 14 and the energy transmission surface 140. The coupling medium also reduces scattering by hydrating a portion of the eyelid skin surface (such as the stratum corneum).

[0110] Figure 2G1 is a schematic block diagram of another embodiment of an eye treatment device 100 having a power module 110, an energy converter module 120, an optional energy waveguide module 130, an energy transmission surface 140, and an image converter 155 integrated into a scleral shield 300. The image converter 155 allows at least a portion of the energy from the energy transmission surface 140 to be redirected to the inside of the eyelid 14. For example, the eyelid 14 can be located between the energy transmission surface 140 and the scleral shield 300 (including the image converter 155). The energy transmission surface 140 directs energy to at least one of the outside of the eyelid and the image converter 155. The image converter 155 is capable of redirecting energy from the energy transmission surface 140 to the inside of the eyelid. The benefit of directing energy to the inner surface of the eyelid via the image converter 155 is that an efficient mode of delivering energy (and therefore heat) to at least that portion of the inner surface adjacent to the lid margin can be provided. By combining this heating pattern (via image converter 155) with a heating pattern that directs energy through the eyelid, the overall heating efficiency of the inner eyelid surface can be optimized, and preferential additional heating of the inner surface adjacent to the lid margin can be achieved, as this is where significant blockage and obstruction may occur. Additional temperature sensors can be positioned near the inner eyelid surface tissue adjacent to the lid margin where preferential additional heating can occur (see below). Figure 3A described and depicted).

[0111] Similar to Figure 2C , Figure 2H 1 is a schematic block diagram of another embodiment of an eye treatment device 100 having a power module 110, an energy converter module 120, an optional energy waveguide module 130, an energy transmission surface 140, and a scleral shield 300. In some embodiments, the scleral shield 300 may further include an energy conversion coating 194 that is activated by certain types of energy that pass through the eyelid. In one embodiment, the energy conversion coating 194 is capable of redirecting the 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, the coating is phosphorescent. By way of example, the energy transmitted through the eyelid can be visible or infrared light of a wavelength that easily passes through tissue and is rarely absorbed, and once the energy reaches the energy conversion coating 194, the phosphorescent material emits light energy of a different wavelength that is more easily absorbed by tissue adjacent to the coating, which in a preferred embodiment is the inner surface of the eyelid containing the meibomian glands. In another embodiment, some form of energy absorbed by the coating triggers an exothermic chemical reaction that can heat the inner surface of the eyelid. FIG. 2A to FIG. 2HSome embodiments of the device may also include one or more of the following: a scleral shield with a support arm, a reflective imager integrated into the scleral shield, a display of different temperatures, a consumable part, a connector and circuit system for communicating between the device and the consumable to identify the consumable and prevent reuse, a data logger, and a recorder and camera with recording and / or transmission capabilities activated by certain types of energy passing through the eyelid. In one embodiment, the energy conversion coating 194 is capable of using the same form of energy as originally passed through the eyelid to redirect the energy back toward the inside of the eyelid. In another embodiment, the energy conversion coating 194 can change the type of energy and guide or emit the changed energy in a preferred direction. In one embodiment, the coating is a phosphorescent material activated by energy transmitted through the eyelid from the energy transmission surface 140. By way of example, the energy transmitted through the eyelid can be visible light or infrared light of a wavelength that easily passes through tissue and is rarely absorbed, and once the energy reaches the energy conversion coating 194, the phosphorescent material emits light energy of a different wavelength that is more easily absorbed by tissue adjacent to the coating, which in a preferred embodiment is the inner surface of the eyelid containing the meibomian glands. In another embodiment, some form of energy absorbed by the coating triggers an exothermic chemical reaction that can heat the inner surface of the eyelid.

[0112] Figure 3A is a schematic side plan view of one embodiment of an eye treatment device 200. Figure 3A The eye treatment device 200 is shown positioned relative to the eyeball 20 to treat MGD, blepharitis, and other medical conditions of the eyelid 14. In some embodiments, the eye treatment device 200 is configured to heat the inner and / or outer surfaces of the eyelid when compressing the eyelid. When heat from the eye treatment device 200 is transferred to the eye system 10, particularly for treating tissue (such as the meibomian glands), the heat can soften the meibum and thereby allow the meibum to drain more easily during massage or eye exercises. The eye treatment device 200 may include FIG. 2A to FIG. 2H The configuration of modules and additional components for operating the eye treatment device 200 are depicted.

[0113] The eye treatment device 200 may include a housing 202 coupled to a removable or consumable portion 260, which may be coupled to the housing 202 via an engagement device 186, which may be a pin, an alignment guide, a sliding lock, or the like. The housing 202 may include a power module 110, an optional controller 212, an energy converter module 120, and an energy transfer surface 140 in a slidable relationship with the energy converter module 120 along a movement path 145. Alternatively, the energy transfer surface 140 may be linked to or part of the energy converter module 120, and optionally a thermal management structure 220, which together may be in a slidable relationship relative to the housing 202 or other portions of the eye treatment device 200. For example, movement of the energy transfer surface 140 and the linked portion may be accomplished using an actuator 182. Some embodiments of the energy converter module 120 (e.g., Figure 3A1 ) may include an LED device formed of one or more of: an LED emitter 207, an LED lens 208, a thermal management structure 220, and an energy converter module driver 209. The housing 202 may further include: a visualization device 160 for enhancing monitoring of the eyelid margin during diagnosis and treatment; a display or dashboard 218 that displays various temperatures of the eyelid (such as the inner surface temperature and / or the outer surface temperature); a data logger 214; a recorder 213; and a circuit system 226a that enables communication between the device and a consumable circuit system 226b to identify the type of consumable, which is used to ensure that the consumable is properly aligned and / or prevent the consumable from being reused. The consumable portion 260 may include a scleral shield 300 that can be positioned between the eyelids 12, 14 and the eyeball 20 to cover sensitive anatomical structures of the eye system 10 (shown in FIG. 1 ). For example, the scleral shield can be positioned on the sclera 21 and the cornea 22, and can also provide protection for other internal anatomical structures of the eye (e.g., the iris 24, the pupil 25, the lens 26, and other light-sensitive anatomical structures of the eye system 10). The use of the scleral shield 300 can increase safety and reduce the possibility of harmful light emissions from the energy converter module 120 reaching and damaging sensitive anatomical structures of the eye. The scleral shield 300 can be formed of an energy absorbing material and / or can have an energy absorbing front surface 302. In either case, the energy transmitted through the eyelid and absorbed by the scleral shield 300 or the energy absorbing front surface 302 can heat the shield or the front surface accordingly, and thereby provide warming to the inner surface of the eyelid. The rear surface and edge of the scleral shield 300 are preferably made of materials and processes that ensure a smooth, burr-free finish that does not cause damage to the cornea or other sensitive structures of the eye or reduces the possibility of causing damage to them. In a preferred embodiment, the rear surface and edges are covered with expanded Teflon (ePTFE) material. The scleral shield 300 may also incorporate one or more temperature sensors 310 to monitor temperature, and force or pressure sensors 221 to monitor the amount of force or pressure applied to the eyelid. Electrical conductors such as wires 420 may connect the sensors 310 and 221 to the circuitry in the housing 202. Figure 3B One embodiment of a scleral shield 300 is shown that further includes an image converter 155, which, as previously described, is capable of viewing the inside of the eyelid 14 and the meibomian glands behind the eyelid. In some embodiments, the scleral shield 300 may further include a data transmission device and / or an embedded power source, both of which are discussed in more detail below as a data transmission device 320 and an embedded power source 330, as shown in FIG. Fig. 7ABy way of further illustration, the scleral shield 300 can be coupled to the housing 202 in various ways, such as by one or more wires 420 having an insulator and sufficient mechanical strength to serve as a support arm 262. Additionally, some embodiments can have circuit systems 226a and 226b for communication between the device and the consumable.

[0114] In some embodiments, a lens 208, such as an LED lens, may be used on the LED emitter 207. In some embodiments, the LED lens 208 may be a specially shaped lens for controlling the direction and intensity of the LED emitter 207 to the desired treatment tissue and / or scleral occluder 300. In some embodiments, the energy transfer surface 140 may be used as a lens or in combination with a lens to focus and direct energy from the energy converter module 120 or LED emitter 207 to the desired treatment area.

[0115] Each of these components may be used alone or in combination with other components of any of the embodiments described herein.

[0116] Eye treatment device 200 may include power module 110 for powering the various components of eye treatment device 200 and may be electrically coupled to some or all of the components. In some embodiments, power module 110 is battery powered, using conventional batteries or rechargeable batteries that may be coupled to a recharging system. In other embodiments, power module 110 may be coupled to an external power source, such as an electrical outlet or an external battery supply. In some embodiments, power module 110 may be electrically coupled to controller 212 to receive instructions from controller 212 to provide power to the various components of eye treatment device 200.

[0117] In certain embodiments with a controller 212, the controller 212 can receive an input instruction from a user (e.g., through another module or device, such as a user interface device 270 of a smartphone, such as a button, switch, touch screen, voice command) to emit light from the LED emitter 207. Upon receiving the user input instruction, the controller 212 can direct the power module 110 to deliver energy to or from the energy converter module driver 209, which enables the LED emitter 207 to convert the electrical energy from the power module 110 into another form of electromagnetic energy (such as light). In this way, the energy converter module driver 209 and the LED emitter 207 can act as a converter of the electrical energy received from the power module 110.

[0118] The energy converter module driver 209 may include any LED power and control circuitry, whether configured as an actual printed circuit board, integrated circuit, or discrete components. In some embodiments, the energy converter module driver functions as an LED driver, i.e., provides a controlled current, voltage, or power level through the LED emitter 207 within the LED specifications to provide the desired illumination intensity obtained thereby. Optionally, the LED printed circuit board may include a pulse width modulation function, a PID circuit, or a similar scheme to modulate the effective intensity of the emission over time to achieve the desired heating of the target area of ​​the eyelid.

[0119] The LED emitter 207 is a part of a type of energy converter module 120, configured to emit light of the appropriate wavelength necessary to perform the desired treatment. The treatment may include one or more of the following: diagnosing the eyelid by illuminating the inner and / or outer surfaces, the eyelid margins, and / or the meibomian glands behind the eyelids 12, 14; heating the target tissue area of ​​the eye system 10 (e.g., 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 description of the various devices herein (including the eye treatment device 200) is exemplary and not limiting. Thus, for example, although the detailed description refers to specific components and circuit systems with specific functions, this does not limit the present disclosure to those specific embodiments. For example, although LEDs are mentioned, other light sources may be used, such as incandescent lamps, xenon, halogen lamps, high intensity discharge, cold cathode tubes, fluorescent lamps, lasers, and other light sources or energy sources. Similarly, although reference is made to a controller 212 and an energy converter module driver 209, it should be understood that the controller may be integrated with the driver circuitry of the light source, or with the circuitry of a solid-state or other power supply, or other configurations may be used to provide the desired results. In addition, some or all of the functions described as being processed or controlled by the controller 212 may be implemented using discrete logic or analog circuitry, or a combination thereof. In addition, although a number of different embodiments of the eye treatment device 200 are schematically shown, they may be produced in a variety of handheld or stationary configurations with optional gripping surfaces, manipulation and control structures, etc. In addition, the devices described herein may be designed for use in a variety of environments, including home use and use within an eye care professional's office, health clinic, or other health care facility.

[0120] Alternatively, in some embodiments, the energy converter module 120 may be, for example, a broad spectrum lamp, such as an incandescent lamp, a xenon lamp, or a halogen lamp. Such a broad spectrum lamp may be used in conjunction with one or more color filters to remove specific wavelengths that are not necessary for treating an eye condition or that may be harmful to treatment tissue in a target area of ​​the ocular system 10 (e.g., the meibomian glands 18) during application of energy from the energy converter module 120 to the treatment tissue.

[0121] In some embodiments, the energy emitted from the power module 110 can be converted into visible light and can be emitted by the LED emitter 207. For some embodiments, it is desirable to use light having a wavelength that is selected to: a) penetrate the eyelid to the depth of the meibomian glands (e.g., typically about 1-2 mm in some individuals) or other adjacent target tissue in the eyelid and can be absorbed there; b) minimize the amount of light that penetrates beyond the eyelid tissue; and c) minimize the amount of heating that occurs at the eyelid surface. For example, in some embodiments, the LED emitter 207 can emit light having a wavelength in the range of about 400-700 nm. In some embodiments, the LED emitter 207 can emit substantially monochromatic light that is selected for optimal treatment of the meibomian glands 18 in the eye system 10. In some embodiments, the LED emitter 207 can emit light within a range of wavelengths that can be selected based on the patient's treatment requirements, or based on the intended purpose of a particular step in a multi-step treatment regimen.

[0122] In some embodiments, an illumination source with an emission wavelength in the range of 500-600nm is selected. When selecting a wavelength in the range of 500-600nm, multiple considerations can be taken into account. For example, this range can be selected to achieve the highest absorption of light by tissue. Light incident on mammalian skin can be reflected, transmitted or absorbed. Reflection varies with skin properties, wavelength and angle of incidence. Light that reaches the skin surface orthogonally to the skin surface plane reflects less than light that reaches the skin at an oblique angle. The transmission of light through the skin varies with internal scattering, wavelength and absorption. Internal scattering varies with the chemical and physical properties of the skin and underlying tissues. The thickness of the eyelids, the density of keratinocytes, collagen and fat can play a role. Absorption varies mainly with the concentration and distribution of certain molecules called chromophores, which tend to selectively absorb certain wavelengths of light. In human skin, the main chromophores that absorb light in the visible spectrum are oxyhemoglobin, deoxyhemoglobin, various melanins, and to some extent water. Water does not significantly absorb light of wavelengths before the deep red and infrared parts of the spectrum. Melanin tends to have fairly high absorption across the visible spectrum, which tapers off as wavelength increases. The two absorption peaks for oxygenated hemoglobin occur at about 532nm and 577nm. The peak for deoxygenated hemoglobin is at about 550nm.

[0123] In a number of different embodiments, engineering constraints also affect wavelength selection. The wavelength selected is a wavelength that can be emitted by the device, which can be easily produced in a practical configuration and has a power and physical packaging suitable for the device that delivers light energy to the eyelid. In the case of very high power LEDs, the current selection is limited, but it may be improved in the future. For example, LED Engin (San Jose, California) produces a 10W version of a green LED, such as the LZ4-00G108, which has a nominal center / peak wavelength of about 523nm. Limited quantities with peak wavelengths of about 527 and 532nm are also available.

[0124] Various embodiments emit wavelengths within the 500-700nm portion of the visible spectrum to produce the desired tissue heating effect without excessive transmission through the eyelid (and subsequent undesirable heating of structures outside the eyelid), and without excessive surface heating. In addition, for embodiments not incorporating a scleral shield, emitting wavelengths within this portion of the visible spectrum avoids undesirable portions of the electromagnetic spectrum (including ultraviolet, infrared, and blue light).

[0125] In some embodiments, longer wavelengths of light are used to penetrate deeper into the tissue. For example, "red" and near infrared (NIR) with wavelengths between 700-1000nm are easier to pass through the eyelids than the above wavelength ranges, thereby penetrating deeper. There is an "optical window" of about 800-900nm in human tissue, at which the absorption of chromophores is at the lowest level, so the energy passes through the tissue and eyelids most efficiently. For applying phototherapy to the eyelids without using a scleral shield, NIR may not be used because too much light energy can pass through the eyelids directly to the eyes and may affect the sensitive tissues of the eyes. However, when a scleral shield is used to protect the eyes, NIR can be used to advantageously pass through the eyelids. For example, 850nm NIR can pass through the eyelids and be absorbed by the scleral shield, which in turn can warm up the adjacent tissues on the inner surface of the eyelids. For the sake of completeness of the discussion, it should be noted that some wavelengths of short-wavelength and medium-wavelength infrared (sometimes referred to as IR-B and IR-C) are absorbed by water in an amount higher than the highest combined absorption of other chromophores discussed above. In particular, a wavelength of 3,000 nm has been shown to have this higher absorption. As such, there may be embodiments that safely use this wavelength, or other wavelengths within the band, with or without a scleral occluder. It should be noted that there are other "optical windows" for these higher wavelengths (besides the windows mentioned at 800-900 nm), which may be advantageously utilized in some embodiments.

[0126] In some embodiments, an illumination source that emits blue or violet light in the range of 400-450 nm may be used to reduce and / or eliminate bacteria in the eye system 10. Exposure to visible light, and more specifically to blue or violet wavelengths, is known to inactivate certain bacterial species. Common bacteria include Staphylococcus aureus, Staphylococcus epidermidis, Bacillus campestris, and Propionibacterium acnes. When selecting a wavelength in the range of 400-450 nm, a number of considerations may be taken into account. For example, it is important that the emission source (LED) does not emit a significant amount of energy below about 400 nm, which is within the UVA spectrum and may be associated with skin cancer.

[0127] In another embodiment, one or more wavelengths of light may be selected that are preferentially absorbed by the exoskeleton, internal structures, or eggs of the Demodex mite to kill, inactivate, or interrupt the reproductive process.

[0128] In some embodiments, an illumination source can be used to characterize tear film thickness and stability. For example, the energy converter module can have a cobalt blue source, and the visualization device 160 (e.g., viewing lens) can have a Wrattan yellow filter, and the patient can be provided with fluorescein eye drops, where the clinician can view the surface of the eye through the Wrattan filter to measure the tear film breakup time. Alternatively, various wavelengths of photon energy can be illuminated onto or through the surface of the eye, with or without indicative eye drops and through direct visual observation or image capture and processing, the stability and / or thickness of the tear film and / or lipid layer can be determined.

[0129] In another embodiment where LEDs are used as illumination sources, the LED emitter 207 may include one or more multi-spectrum LEDs or multiple LEDs to emit 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 different wavelengths. The LED emitter 207 may emit light from each different extended LED continuously or simultaneously. For example, in some embodiments, the LED emitter 207 may include a red, green, blue (RGB) LED system or other multi-spectrum LED system to emit light of various wavelengths within the visible spectrum or 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 can select the wavelength of light to be emitted from the multi-spectrum LED. In addition, the LEDs may be manufactured using a special phosphor coating to produce the most efficient output spectrum relative to the input power.

[0130] In some embodiments, LED emitter 207 may include a high intensity LED array. In some embodiments, the high intensity LED array (as part of LED emitter 207) may operate at an input power rating of about 0.5-75W, but preferably in the range of 1-10W. To help keep the temperature of energy converter module 120 within functional limits, a thermal management structure 220 (such as a heat sink with other significant thermal mass) may be thermally linked to LED emitter 207. In a particular embodiment, the high intensity LED array may emit light at a wavelength between about 500-600nm.

[0131] In some embodiments, the energy converter module 120 can provide electromagnetic energy in the form of infrared energy, such as in the NIR band described above, to the treatment tissue. For example, the LED emitter 207 can be a commercially available LED, such as LZ4-00R408, which can emit NIR at 850 nm and is manufactured by LED Engin, Inc. (San Jose). In addition, the energy converter module 120 can be another infrared energy source instead of an LED light source, such as an incandescent lamp, a xenon lamp, a halogen lamp, a cold incandescent lamp, or a halogen broad spectrum lamp configured to emit infrared energy to the treatment tissue site.

[0132] The eye treatment device 200 may include a reflector (such as reflector 210 in other embodiments described below) that may be used as a waveguide to direct electromagnetic energy (e.g., light) emitted from the energy converter module 120. The reflector may be configured to uniformly direct electromagnetic energy from a point source (such as LED emitter 207) across the energy transmission surface 140 to a target treatment site of the patient.

[0133] 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.

[0134] Figure 3AAn energy transfer surface 140 forming part of an eye treatment device 200 is shown. The energy transfer surface 140 has a slidable relationship relative to the energy converter module 120 along a travel path 145. The energy transfer surface 140 can be positioned in the housing 202 at a location distal to the energy converter module 120 and between the energy converter module 120 and a tissue treatment site of the eye system 10. The energy transfer surface 140 positioned in this manner can be passed through by electromagnetic energy transmitted from the energy converter module 120, or receive and transmit the electromagnetic energy. In some embodiments, the energy transfer surface can be concave (relative to the eye treatment device 200) so that the energy transfer surface 140 corresponds to the shape of the eyelids 12, 14 when closed. The energy transfer surface 140 can be shaped so that any electromagnetic energy emitted from the energy converter module 120 must pass through the energy transfer surface 140.

[0135] In some embodiments, the energy transfer surface 140 is positioned adjacent to the eyelids 12, 14 without being in physical contact with the eyelids 12, 14, but rather transferring heat radiatively to the treatment tissue. 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 transmitted from the energy converter module 120 without significantly hindering the desired energy type or wavelength from reaching the treatment tissue. In some embodiments, the energy transfer surface 140 may be made of optical plastic, sapphire, glass, calcium fluoride, or fiberglass. Its outer surface may be easy to clean and may be scratch-resistant. Optionally, a temperature sensor 310 may be positioned on, in, or adjacent to the energy transfer surface 140 to provide temperature feedback of the outer surface of the energy transfer surface 140 or the eyelid.

[0136] In some embodiments, the energy transmission surface 140 can be configured to operate in conjunction with the energy converter module 120 to filter unwanted wavelengths from reaching the treatment tissue or other parts of the ocular system 10. For example, in some embodiments, the illumination source can transmit electromagnetic energy in the IR spectrum and the visible spectrum. The energy transmission surface 140 can be used to allow energy in the visible spectrum to pass through, for example, but filter out energy in the IR spectrum. Similarly, if it is desired that only one color of energy reach the treatment tissue, the energy transmission surface 140 can be used as a bandpass filter or in conjunction with a filter that limits the passage of wavelength energy other than the desired color.

[0137] In some embodiments, the energy transfer surface 140 can be configured to physically contact the eyelids 12, 14. As discussed above, in some embodiments, the energy transfer surface 140 can be in a slidable relationship with the energy converter module 120 along the movement path 145. This allows the energy converter module 120 to be in a fixed relationship with the eyelid when the energy transfer surface 140 moves forward to contact the eyelids 12, 14. Alternative approaches for reducing the space between the outer surface of the eyelids 12, 14 and the energy transfer surface 140 are possible. For example, the energy converter module 120 and the energy transfer surface 140 can move toward the eyelid together, wherein the scleral shield 300 remains in a relatively fixed position, or the scleral shield 300 can move relative to the rest of the device. In any case, the movement is preferably performed manually by the clinician to allow the clinician to obtain a certain degree of tactile feedback. In some embodiments, the eye treatment device 200 may include an actuator 182, such as a lever, button, wheel, slider, or switch, for moving the energy transfer surface 140.

[0138] In some embodiments, at least a portion of the energy-transmitting surface 140 can be configured to be disposable over a pressure relief or eyelid pad 147, such as Figure 3A Preferably, such an outer eyelid pad 147 is incorporated into the consumable portion 260 of the device, wherein when the consumable portion is attached to the housing 202, the outer eyelid pad 147 is automatically aligned with the energy transmission surface 140 and loaded thereon.

[0139] In some embodiments, the energy transfer surface 140 can be heated to transfer heat conductively to the treated tissue. In other embodiments, most of the tissue heating occurs due to radiative heating from the energy converter module 120 to the tissue and / or scleral shield 300, wherein substantially all of the desired electromagnetic energy passes through the energy transfer surface 140, with little or no heating of the energy transfer surface 140. In still other embodiments, tissue heating can be achieved by a combination of conductive heating due to preheating or active heating of the energy transfer surface 140 and radiative heating of the tissue and / or scleral shield. The energy transfer surface 140 can be combined with an energy absorbing layer or pattern that can be preheated by light energy or other means prior to contact with the outer surface of the eyelid, for example, preheated to up to 42 degrees Celsius. Alternatively, the energy transfer surface can be made of a thermally conductive material and can be heated by a heater thermally linked to the energy transfer surface 140. Where the energy transfer surface 140 is made of a thermally conductive material, the material may be transmissive to the energy source (e.g., light) from the energy converter module 120, or the material may be solid, opaque, or otherwise non-transmissive to another form of energy other than conductive heating. Where the energy transfer surface 140 is opaque or non-transmissive, it may be made of a conductive metal such as copper or aluminum, in which case the energy transfer surface 140 may be heated by the energy converter module 120, including any means of heating a thermal mass (e.g., a resistive heater), and then pushed against the eyelid to conductively heat the eyelid. Where the energy transfer surface 140 is transmissive to another form of energy and is thermally conductive, the energy transfer surface may be made of materials such as sapphire, calcium fluoride, diamond, graphene, etc. In a preferred embodiment, up to three heating modes can occur simultaneously, namely: i) heating the inner surface of the eyelid using red or infrared light transmitted to the energy absorbing scleral shield 300; ii) radiative heating of the eyelid tissue by visible light (e.g., green light) absorbed by the chromophore; and iii) conductive heating of the eyelid tissue by contacting the preheated energy transmission surface 140 with the outer surface of the eyelid. It should be understood that a significant advantage of using the light-based heating technology described herein, specifically infrared heating of the energy absorbing surface, alone or in combination with the other two heating modes (visible light heating of the chromophore and conductive heating of the tissue), is that heating of the target tissue can be achieved significantly faster than any conventional method of conductively heating the outer or inner surface of the eyelid. Specifically, with these combined modes, the meibomian gland tissue can be brought to a temperature of up to, for example, about 40-42 degrees Celsius in less than one minute. Specifically, in some cases, the meibomian gland tissue can be brought to approximately 40-42 degrees Celsius within 10 seconds, 15 seconds, 20 seconds, 25 seconds, 30 seconds, or 45 seconds.

[0140] like Figure 3A As shown, a visualization device or instrument 160 can be used to view the eyeball 20. In some embodiments, the visualization device 160 can be a part of the eye treatment device 200. In other embodiments, the visualization device 160 can be a separate component. The visualization device 160 can include, for example, a magnifier, a camera, a microscope, a slit lamp instrument, or other suitable visualization instruments.

[0141] In some embodiments, the scleral shield 300 may further include an image converter 155 that allows for viewing of a transilluminated image of a portion of the eyelid and meibomian gland. As previously described, the image converter may include, for example, one or more reflective surfaces, mirrors, light pipes, prisms, fiber optic bundles, image sensors, or other suitable image conversion devices. Figure 3A As shown, image converter 155 is integrated into scleral occluder 300, but in other embodiments, image converter 155 may be a separate component.

[0142] In some embodiments, an additional protective element 258 may be used to prevent unwanted photon energy (such as IR or blue / violet light) from being reflected from the transillumination element back to the clinician. For example, the protective element 258 may be a thin, opaque shield or filter (blocking at least visible blue and IR light energy) that oscillates, flips, or slides (e.g., over the image converter 155 and possibly the energy converter module 120 or energy delivery surface 140) during the heating and blue / violet light therapy modes. Figure 3A Alternatively, the image converter 155 and / or a portion of the visualization device may include a selective filter or photochromic element such that during low-level illumination of the eyelid, for evaluation of transilluminated images of the meibomian glands, the photochromic element is passed by substantially all light, whereas during a heating mode where infrared energy or high-level visible light may be used, some or all of that energy may be attenuated, thereby protecting the clinician from injury.

[0143] By way of further clarification, several classes of embodiments will now be described. In one class of embodiments, the device is intended for self-administered use by an individual, typically in a home use environment. For such embodiments, a scleral shield may not actually be used, and therefore there may be a higher risk of unwanted forms of energy (such as certain wavelengths of light or infrared energy) penetrating the eyelid and reaching sensitive anatomical structures of the eyelid. As such, such embodiments may sometimes be limited to the use of safer forms of energy, such as visible light in the range of 450-700nm. In another class of embodiments, the device is intended for use by an eye care professional in a controlled office environment, where a treatment system having a scleral shield component can be more safely utilized. In such embodiments, the scleral shield may be designed such that its shape and material increase the likelihood that little or no damaging energy will reach sensitive structures of the eye.

[0144] In-office device - Embodiments of the in-office device may include one or more of the following: diagnosing meibomian glands; treating meibomian glands; and performing antimicrobial treatment on the ocular system. In a preferred set of embodiments, the meibomian glands are diagnosed in two ways. First, visible or IR illumination from an energy converter module is used, which is directed to the outer surface of the eyelid to view and evaluate the meibomian glands using an image converter with or without a visualization device. Second, the eyelid is slightly compressed while observing the lid margin to note the amount and quality of oily secretions from the meibomian gland duct. For treatment, in one set of embodiments, the eyelid is heated and compressed. Near infrared (NIR) energy at approximately 800-900nm from the energy converter module is transmitted through the eyelid to the scleral shield, which then heats the inner surface of the eyelid and thereby increases temperature. In addition, visible light (green light) in the range of approximately 500-600nm from the energy converter module is directed to the outer surface of the eyelid to heat the tissue through chromophore absorption. Next, the clinician moves the energy transfer surface toward the eyelid via direct or indirect manual control to compress the eyelid between the energy transfer surface and the scleral shield. Optionally, the energy transfer surface can be pre-warmed and / or actively warmed during treatment to provide some conductive heating of the outer eyelid. The temperature of the inner and / or outer surface of the eyelid can be measured and provided to the clinician. The clinician applies heating energy and compression force while visually monitoring the eyelid margin to optimize the drainage of meibum from blocked meibomian glands. Finally, the energy converter module can generate blue / violet light in the range of approximately 400-450nm to reduce and / or eliminate bacteria in the eye system 10.

[0145] Home Devices - Embodiments of home devices use visible light transmitted from an energy converter module through an energy transfer surface directed at the outer surface of the eyelid to heat the tissue through chromophore absorption. In certain preferred embodiments, the visible light can be high intensity broad spectrum (e.g., white) LED light passed through certain filters, or can be a green, yellow-green, or white-green LED (500-600nm) without passing through filters. In some embodiments, the energy transfer surface is transparent to visible light and is thermally conductive, allowing the surface to be compressed against the eyelid (see Figure 2A ) before or during heating (e.g., to 42 degrees Celsius). In some embodiments, the energy transfer surface may have an extension element 143 (e.g., Figure 2B The energy transfer surface can conform to the shape of the eyelid and apply pressure to the surface of the eyelid to shorten the optical path length of the radiated energy. In some embodiments, an eye shield is used to prevent light from escaping from the intermediate treatment area and to keep at least a portion of the device at a predetermined distance from the eyelid or periocular area.

[0146] FIG. 4A to FIG. 4C is a representation of another embodiment of an eye treatment device. Figure 4A is a schematic side plan view of eye treatment device 200. Figure 4A The eye treatment device 200 is shown positioned adjacent to the eyeball 20 to treat MGD, blepharitis, and other medical conditions of the eyeball. FIG. 4A to FIG. 4D , FIG. 5A to FIG. 5B , Figure 6 , FIG. 11A to FIG. 11B , Fig.12 , Fig.13 and Fig.15A , eye sensitive structures, such as the cornea, iris, pupil lens, and adjacent elements are described as a single element as the front eye structure 27. The eye treatment device 200 may include the configuration of modules depicted in Figures 2 and 3, as well as additional components for operating the eye treatment device 200. The eye treatment device 200 may include a power module 110, a controller 212, an energy converter module 120, an energy waveguide 210 in the form of a reflector, and an energy transfer surface 140. The energy converter module 120 of some embodiments may include an LED device formed by one or more of the following: an LED emitter 207, an LED lens 208, and an energy converter module driver 209. Each of these components, alone or in combination with other components (shown or not disclosed herein) may correspond to or be related to FIG. 2A to FIG. 2HComponents of the eye treatment device 200 may be contained within the housing 202. Some embodiments of the eye treatment device 200 may also include a consumable portion 260 and / or a scleral shield 300, as shown in FIGS. Figure 6 shown.

[0147] The energy converter module driver 209 may include any LED power and control circuitry, whether configured as an actual printed circuit board, integrated circuit, or discrete components. In some embodiments, the energy converter module driver functions as an LED driver, i.e., provides a controlled current, voltage, or power level through the LED emitter 207 within the LED specifications to provide the desired illumination intensity obtained thereby. Optionally, the LED printed circuit board may include a pulse width modulation function, a PID circuit, or a similar scheme to modulate the effective intensity of the emission over time to achieve the desired heating of the target area of ​​the eyelid.

[0148] The energy transfer surface 140 can be positioned at a location distal to the energy converter module 120 relative to the housing 202 and between the energy converter module 120 and the tissue treatment site of the eye system 10. The energy transfer surface 140 positioned in this manner can be passed through by electromagnetic energy transmitted from the energy converter module 120, or receive and transmit the electromagnetic energy. The energy transfer surface can be concave so that the energy transfer surface 140 corresponds to the shape of the eyelids 12, 14 when they are closed and covering the eyeball 20. The energy transfer surface 140 can be an integral part of the housing 202 and can significantly seal the distal end of the eye treatment device 200. In addition, the energy transfer surface 140 can move independently or with the energy converter module 120 relative to the housing 202. A sealing element (e.g., a bellows, a gasket, an O-ring, or a similar sealing device) can be used to prevent contamination of the interface between the movable element and the housing.

[0149] In some embodiments, the energy transmission surface 140 is positioned adjacent to the eyelids 12, 14 without being in physical contact with the eyelids 12, 14, but rather radiating heat to the treatment tissue. The energy transmission surface 140 may be substantially transparent to the desired electromagnetic energy transmitted by the energy converter module 120 to allow heat energy to be transmitted from the energy converter module 120 without significantly hindering the desired energy type or wavelength from reaching the treatment tissue. In some embodiments, the energy transmission surface 140 may be made of optical plastic, sapphire, glass, calcium fluoride, or fiberglass. Its outer surface may be easy to clean and may be scratch-resistant. In some embodiments, the energy transmission surface 140 may be configured to operate in conjunction with the energy converter module 120 to filter unwanted wavelengths from reaching the treatment tissue or other parts of the eye system 10. For example, in some embodiments, the illumination source may transmit electromagnetic energy in the IR spectrum and the visible spectrum. The energy transmission surface 140 may be used to allow energy in the visible spectrum, for example, to pass through, but filter out energy in the IR spectrum. Likewise, if it is desired that only one color of energy reach the treatment tissue, the energy transmission surface 140 may be used as a bandpass filter, or in conjunction with a filter that limits the passage of wavelengths of energy other than the desired color. Alternatively, as previously described, the energy transmission surface 140 may include a disposable eyelid pad 147. Such an eyelid pad 147 may be transparent to all relevant wavelengths of light or other forms of energy, or it may have the desired filtering properties, and it may additionally include a temperature or pressure sensor.

[0150] In some embodiments, the energy transfer surface 140 can be configured to be in physical contact with the eyelids 12, 14 and can conductively transfer heat to the treatment tissue (or promote cooling of the eyelids, as described below). In other embodiments, a large amount of tissue heating occurs due to radiative heating from the energy converter module 120, wherein substantially all of the desired electromagnetic energy passes through the energy transfer surface 140 and is absorbed by the tissue, thereby causing the tissue to be heated and little or no heating of the energy transfer surface 140. It should be understood that the device can be configured without the energy transfer surface 140. However, the energy transfer surface 140 provides certain benefits, such as facilitating cleaning of the primary contact surface with the patient, and the energy transfer surface 140 has the potential to assist in maintaining the outer surface of the eyelid within a desired temperature range and provide a convenient location for certain safety sensors. In embodiments where a disposable outer eyelid pad 147 is used as part or all of the energy transmission surface 140, the outer eyelid pad 147 may contain a temperature sensor, but instead, a non-contact temperature sensor, such as a thermopile or pyroelectric sensor, is preferably utilized that is positioned proximal to the outer eyelid pad 147 (relative to the housing). In such embodiments, the outer eyelid pad 147 is preferably transparent to the infrared wavelengths that the non-contact temperature sensor is designed to sense.

[0151] Figure 4B is a schematic front plan view of energy converter module 120 of eye treatment device 200. Figure 4B As shown, the LED emitter 207 can be configured as a single LED array. As shown, the LED emitter 207 is arranged into a 3×3 LED array (such as the LZ9 configuration provided by LED Engine), but the LED emitter 207 is not limited to this arrangement and can include various numbers of LED arrays arranged in various columns and rows; and some embodiments may include a single LED or other type of lighting source. The reflector 210 can partially or completely surround the LED emitter 207 so that it can direct the emission of light from the LED emitter 207 in a desired manner. The LED lens 208 can be positioned on the LED emitter 207 and within the inner diameter of the reflector 210.

[0152] Figure 4C is a schematic side plan view of one embodiment of an ocular treatment device 200, wherein the device is operable and transmits light 211 to the ocular system 10 and treatment tissue. Figure 4C, light 211 is emitted from the energy converter module 120. A portion of the light 211 may initially be radiated at an angle such that the light does not reach the energy transfer surface 140 without correction and reaches the treatment tissue. As shown, the reflector 210 may reflect or direct the angled light toward or toward the energy transfer surface 140, thereby improving the heating efficiency of the target tissue. A portion of the light 211 may also be transmitted directly from the energy converter module 120 to the energy transfer surface 140.

[0153] Figure 4D is a schematic side plan view of another embodiment of an ocular treatment device 200. In this embodiment, the transmission of light 211 can be performed without the assistance of reflector 210, for example, if other components of ocular treatment device 200 can be used to control the direction and intensity of light 211, such as specially shaped lenses, additional lens elements, light pipes, total internal reflection (TIR) ​​elements, refractive elements, diffractive elements, mirror elements, diffusers, and the like or combinations thereof. It may be desirable to control the focus and intensity of the light energy in this manner so that the light energy penetrates deeply but not significantly beyond the target tissue in the eyelids 12, 14, such as the meibomian glands. In some embodiments, energy transmission surface 140 (functioning as a lens or having a lens) can be used to focus and direct light 211 to the desired treatment tissue and away from the central eye axis to avoid the anterior eye structure 27 of the eyeball 20 and other sensitive anatomical structures of the eye, such as the retina. It will be appreciated that the area where the upper eyelid 12 and the lower eyelid 14 meet may be different for each individual, and in most individuals, this area is generally below the central eye axis. However, for the purpose of demonstrating how certain embodiments can reduce the risk of too much light 211 penetrating the eyelid at the central eye axis, a worst-case scenario where the eyelids meet at the central eye axis is shown. It should be further appreciated that at least some of the risks associated with too much radiation penetrating the eyelid and reaching sensitive tissue can be reduced by having the treated individual move his / her eye off-axis so that most of the radiation penetrating the eyelid reaches only the sclera (which is generally less sensitive).

[0154] Figure 4EA specific embodiment is shown that includes additional optical elements that are used to improve the distribution of light energy on the eyelid surface while minimizing the amount of light that passes directly through the central eye axis. The energy converter module 120 includes an LED (such as LZ9 from LED Engin), a prism 280, a forming lens 282, and a face glass 284 (which functions similarly to the energy transmission surface 140 in other embodiments disclosed herein). The eyelids 12, 14 and the eyeball 20 are also shown relative to the optical elements. In this particular design, the prism is a glass element with 6 polished surfaces and a hemispherical concave surface with a radius of 3.5 mm to accommodate the LED. There is no coating on the prism surface. The incident surface and the exit surface can have an anti-reflective coating (optional) to increase the efficiency by about 5-6%. FIG. 4F to FIG. 4H Exemplary details are shown of the shape and size of the prism 280. The material may be BK7, and the surface is preferably polished. Figure 4F is the front view, Figure 4G is a side view, and Figure 4H is a cross-sectional view through section AA. FIG. 4I to FIG. 4L Exemplary details of the shape and size of forming lens 282 are shown. Fig. 4I is the front view, Figure 4J is a cross-sectional view through section AA, Figure 4K is a side view, and Figure 4L It is a perspective view. Figure 4M and Figure 4N It is shown above FIG. 4E to FIG. 4L Theoretical optical performance of the system described in . Figure 4M The light distribution measured as irradiance in Watts per square millimeter on the eyelid surface is shown, where the light distribution is shown to be quite uniform (compared to if the LEDs of the energy converter module 120 were shining directly at the eyelid or through a flat glass energy transmission surface, in which case most of the light would be projected in the middle of the eyelid and very little light would reach the edges). The total flux was calculated to be 0.86 Watts, the maximum irradiance was 2.2 milliwatts per square millimeter, and the uniformity was estimated to be about 80%. Figure 4N The amount of irradiance reaching the eye (ie, passing through the eyelid tissue) is shown. The total flux was calculated to be 0.019 Watts, with a maximum irradiance of 0.18 milliwatts per square millimeter.

[0155] Figure 5A and Figure 5B is a representation of one embodiment of an eye treatment device 200 . Figure 5A is a schematic side plan view of eye treatment device 200, and Figure 5B is a schematic front plan view of an eye treatment device 200. Embodiments of eye treatment device 200 may include a device similar to FIG. 4A to FIG. 4CThe components shown include power module 110 and controller 212, but such components are not Figure 5A and Figure 5B Not shown. Figure 5A Different configurations of energy converter modules 120 are provided to focus and control the direction of light 211. In some embodiments, ocular treatment device 200 can include multiple energy converter modules 120, such that at least one energy converter module 120a can be positioned in an upper region of ocular treatment device 200 to provide electromagnetic energy (e.g., light 211) to target tissue within upper eyelid 12, and at least one energy converter module 120b can be positioned in a lower region of ocular treatment device 200 to provide electromagnetic energy (e.g., light 211) to target tissue located in lower eyelid 14. Having energy converter modules 120a, 120b positioned separately in ocular treatment device 200 allows ocular treatment device 200 to direct light energy directly to target tissue within upper eyelid 12 and lower eyelid 14, and reduce the amount of light that can be directed toward sensitive anterior ocular structures 27 along central eye axis 30.

[0156] like Figure 5A As shown, using the eye treatment device 200 to treat eye conditions such as MGD and blepharitis can include positioning the energy transmission surface 140 of the eye treatment device 200 adjacent to or in contact with the patient's closed upper eyelid 12 and lower eyelid 14. By positioning the eye treatment device 200 in this manner, the upper energy converter module 120a can be positioned above the central eye axis 30 to provide electromagnetic energy in the form of light 211 to the meibomian glands 18 in the upper eyelid 12, and the lower energy converter module 120b can be positioned below the central eye axis 30 to provide electromagnetic energy in the form of light 211 to the meibomian glands 18 in the lower eyelid 14. The eye treatment device 200 can also include a reflector 210 positioned behind the upper and lower energy converter modules 120 to reflect any light back to the treatment tissue.

[0157] like Figure 5AAs depicted, the upper and lower energy converter modules 120 can be tilted at an angle, with the central optical axis of each module oriented to be substantially oblique to the surface of each eyelid, so that most of the light energy entering each eyelid is absorbed before reaching the front eye sensitive structure 27 of the eyeball 20. In some embodiments, the upper and lower energy converter modules 120 can have other directional orientations. For example, in some embodiments, the upper and lower energy converter modules 120 can be positioned so that each central optical axis of the illumination source is substantially horizontal. In this way, light 211 transmitted from the energy converter modules 120 configured in this manner can travel horizontally from the energy converter modules 120 to the energy transmission surface 140, and can then be refracted, diffracted, or reflected at an angle toward the treatment tissue in a manner that maximizes penetration, absorption, and heating in the target area of ​​the eyelid while minimizing the proportion of light reaching the front eye sensitive structure 27.

[0158] Figure 5A and Figure 5B The eye treatment device 200 of the illustrated embodiment includes more than one energy converter module 120 in each of the upper region and the lower region of the eye treatment device 200. For example, Figure 5B As shown, the eye treatment device 200 may include three separate energy converter modules 120a-c in the upper region and three separate energy converter modules 120d-f in the lower region. Other numbers of energy converter modules 120 are contemplated in each of the upper and lower regions of the eye treatment device 200, such as 2, 4, 5, 6, 7, 8, 9, 10, etc. energy converter modules 120. Positioning multiple energy converter modules 120 laterally in the upper and lower regions of the eye treatment device 200 allows for improved coverage and distribution of electromagnetic energy across the width (side to side) of the upper and lower eyelids 12, 14 to better reach the entire width of the target tissue (such as the meibomian glands within the eyelids 12, 14). As also shown Figure 5B As shown, the upper energy converter modules 120a-c and the lower energy converter modules 206d-f may be arranged in an arcuate pattern to follow the upper and lower contours of the eyeball.

[0159] Although Figure 5B It is not depicted, but it is also contemplated that the upper and lower illumination areas of the eye treatment device 200 may be equipped with more than one row of energy converter modules 120. For example, Figure 5BIn one embodiment, one or more additional energy converter modules 120 may be positioned above or below each energy converter module 120a-c. Including additional rows of energy converter modules 120a-c may provide additional vertical coverage and distribution of electromagnetic energy directed to the target treatment tissue. Additionally, although not depicted, it is also contemplated that the eye treatment device 200 may include two sets of energy converter modules 120, reflectors 210, and energy transmission surfaces 204 within the housing, which may be configured similar to binoculars and positioned adjacent to or on both eyes of the patient simultaneously. Such embodiments of the device may speed up treatment time because both eyes may be treated simultaneously.

[0160] Similar to FIG. 5A to FIG. 5B As depicted (having only eight LEDs 120a, 120b instead of six), FIG. 5C to FIG. 5F The side view, top view, front view, and perspective view of the 8-LED configuration are shown, respectively. The eight LEDs 120a, 120b may be of the LZ1 type from LED Engin, Inc., and are shown arranged on a spherical curved surface, which may be a circuit board or energy converter module driver 209 positioned behind a face glass 284, the shape of which matches the curvature of the eyelids 12, 14 adjacent to the eyeball 20. Figure 5G The calculated irradiance pattern on the eyelids 12, 14 is shown, with a total flux of 2.7 Watts and a maximum irradiance of 10.7 milliwatts per square millimeter. Figure 5H The calculated irradiance across the eyelid is shown, with a total flux of 0.07 Watts and a maximum irradiance of 0.6 milliwatts per square millimeter. It should be understood that Figure 5G and Figure 5H The irradiation pattern in Figure 4N The trade-off between these two designs is the compactness of the device versus uniformity. FIG. 4E to FIG. 4L The design of FIG. CF includes a relatively large prism, while FIG. CF does not include any optical elements except the LED and the lens and the face glass. A person skilled in the art can for example FIG. 5C to FIG. 5F The design combines these two approaches by adding one or more prisms 280, shaping lenses 282 or other elements (such as diffusers, gratings, etc.) to optimize the uniformity of light distribution while keeping the size of the device as compact as possible.

[0161] Figure 6 is an eye treatment device 200 (e.g. Figure 5A A schematic side plan view of the eye treatment device 200 depicted. Figure 6Also shown is a scleral shield 300, which together with the eye treatment device 200 can provide a system for treating target tissue with increased safety and efficacy. The scleral shield 300 can be positioned below the eyelids 12, 14 and adjacent to the patient's eyeball 20 to cover the sensitive anterior eye structures 27. For example, the scleral shield can be positioned over the sclera 21 and cornea 22 (see FIG. 1 ), and can also provide protection for other internal anatomical structures of the eye (e.g., iris 24, pupil 25, lens 26, and other light-sensitive anatomical structures of the eye system 10).

[0162] Return to see Figure 6 The scleral shield 300 can have a disc shape similar to a contact lens, or it can be significantly larger to cover the entire cornea and optionally at least a portion of the sclera (as in the case of a conventional corneal shield), or it can have a partial disc or paddle shape, similar to the lower cover portion of a Mastrota paddle. The shield 300 can be positioned in the eye prior to treatment with the eye treatment device 200, or the shield can be integral to the eye treatment device 200 and thus placed in the eye or under the eyelid during treatment. In addition to providing basic safety benefits, the scleral shield 300 can also allow for increased efficacy of the eye treatment device 200. For example, in some situations, the intensity of the energy emitted from the energy converter module 120 must be modulated to prevent damage to sensitive ocular anatomy; however, when the scleral shield 300 is used to protect the ocular anatomy, the intensity of the electromagnetic energy directed from the energy converter module 120 can be increased. As FIG. 7E to FIG. 7G As shown, the scleral shield 300 may include a curved top portion 264 of the shield to prevent scattered photon energy from reaching the cornea, lens, iris, and pupil. Figure 6 is shown as related to Figure 5A and Figure 5B The embodiments of the eye treatment device 200 described herein are used in conjunction with each other, but it should be understood by those skilled in the art that the scleral shield 300 can be used in conjunction with any embodiment of the eye treatment device 200 disclosed herein to create a system for safely and effectively treating eye diseases.

[0163] It should be further understood that the scleral shield 300 can include features that provide even more benefits to the device. For example, the scleral shield 300 of some embodiments is configured to reflect energy away from the eyeball and toward the inner eyelid, thereby providing heating to the inner eyelid. In some embodiments, the scleral shield 300 can also include an image converter 155, as discussed above. The image converter 155 allows viewing of the inside of the eyelid 14 and transillumination of the meibomian glands from behind the eyelid. In some embodiments, the scleral shield 300 can be made of an energy absorbing material or have an energy transmitting surface on the front surface 302 to heat the meibomian glands from behind the eyelid during treatment. The energy absorbing material can be a visible light or IR absorbing material, or a surface made of black plastic or coated with a black substance, any of which can contain carbon black (e.g., 5% or more) or other materials (absorbing light energy, such as red light and NIR).

[0164] In addition, if 7A to 7H As shown in a schematic front plan view of a scleral shield 300, shield 300 may incorporate one or more temperature sensors 310 on the front or back surface of shield 300. Shield 300 may also include a data transmission device 320 so that temperature data can be sent to eye treatment device 200 to monitor or modulate the treatment process so that the inner surface of the eyelid can reach a target temperature without exceeding a predetermined threshold, and to ensure that sensitive tissue of the eye does not exceed another predetermined threshold. In some embodiments, such as Fig. 7A In an embodiment, shield 300 has an embedded power source 330, an array of temperature sensors 310, and a data transmission device 320 that transmits data wirelessly, such as via RF, to an external interrogator 400 (which may be incorporated into eye treatment device 200). In some embodiments, data transmission device 320 includes an antenna embedded in shield 300. In another embodiment, such as Figure 7B In the depicted embodiment, shield 300 may be passive (without power source 330) and configured to be interrogated using RF by external interrogator 400 (which may be incorporated into eye treatment device 200). For example, Figure 7B The schematically shown external interrogator 400 may be configured to provide power to the circuitry in the shield 300 suitable for measuring the temperature(s); the interrogator 400 may also provide power to the transmitter to send the temperature data back to the interrogator 400. In yet another embodiment, for example Figure 7C In an embodiment, the shield 300 may be completely passive and include one or more temperature sensors 310 in the resonant circuit, the resonance point is modulated by changes in the temperature sensor 310 (eg resistance), and the resonance point may be modulated by, for example, using Figure 7CThe schematically depicted external RF sweeper 410 sweeps the external RF field and monitors the impedance or other characteristics of the field to detect the resonance point. In other embodiments, for example Fig.7D In an embodiment, the shield 300 may be physically linked to an external device, such as an interrogator or an eye treatment device 200 (e.g., a laser beam or laser beam array 420 extending from the shield 300 to the external device. Figure 3A ), where such external devices can provide power to active elements in shield 300 and send data to and receive data from shield 300. Wires or wire arrays 420 can include conventional stranded or solid wire conductors with thin-wall insulation, or they can be embedded in more robust structural insulation.

[0165] Fig. 7E and Fig. 7E is a schematic side plan view and front view of a shield 300 having a temperature sensor 310 in the middle and one wire 420 coming out of each side of the shield. The curved upper 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 can be sent to the eye treatment device 200 via wire 420 to monitor or modulate the treatment process to ensure that the inner surface of the eyelid reaches the desired temperature range without exceeding a predetermined threshold, and to ensure that sensitive tissues of the eye do not exceed another predetermined threshold.

[0166] Figure 7G and Figure 7H are schematic side plan and front views of a shield 300 having a temperature sensor 310 in the middle and one wire 420 exiting each side of the shield. In these embodiments, the scleral shield 300 can be coupled to the housing 202 by one or more support arms 262, with the wires positioned on or within the arms, and in some embodiments, the structural portion of the support arms 262 is made of an insulating material that surrounds or otherwise passes through the conductive portion of the wire or wire array 420.

[0167] Figure 8A side view of another embodiment of an eye treatment device 200 is depicted. In some embodiments, such as the embodiment currently depicted, the eye treatment device 200 is configured to apply energy to one eyelid at a time to further protect the tissue of the eye from injury or discomfort. In such a configuration, the energy converter module 120 within the housing 202 is sized to target the meibomian glands and surrounding tissue of one eyelid (e.g., the upper eyelid 12 of FIG. 1 or the lower eyelid 14 of FIG. 1 ), and the energy transfer surface 140 is in a slidable relationship with the energy converter module 120 along a travel path 145. In such an embodiment, the energy transfer surface 140 is also sized to be placed along one eyelid at a time. In use, a patient can be instructed to use such an eye treatment device 200 to open the eye wide, thereby ensuring that the eyelid is relatively far from sensitive structures in the front of the eye and the central eye axis.

[0168] In some embodiments, the eye treatment device 200 includes one or more features to help ensure that the eye treatment device 200 is safely and properly placed on the eyelid. For example, in some embodiments, the eye treatment device 200 includes a pupil alignment guide 242. The pupil alignment guide 242 can be, for example, a mirror with a circular X, a bull's eye, or other target marker. In use, the patient may be able to properly position their eyes by looking at the pupil alignment guide 242, observing the reflection of their pupil in the mirror, and aligning the pupil with the target marker. Additionally or alternatively, in some embodiments, the eye treatment device 200 includes a display 244, which can be a screen, a digital display, or other optical display. The display can present, for example, an image for the patient to gaze at during use, a timer that counts down the remaining treatment time, and / or a reminder message, such as "look up" (explained below). The display 244 can also include a visualization device 160 for enhancing monitoring of the eyelid margin during diagnosis and treatment.

[0169] Figure 8The eye treatment device 200 may include any or all of the features described with respect to other embodiments presented herein. For example, in the depicted embodiment, the energy 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, a laser, an incandescent lamp, a xenon lamp, a halogen lamp, a luminescent lamp, a high-intensity discharge lamp, or a gas discharge lamp that emits light within the visible spectrum. 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 during treatment and warm the inner surface of the eyelid. The scleral shield 300 may also be combined with one or more temperature sensors 310 to monitor the treatment process, thereby ensuring that the inner surface of the eyelid reaches the desired temperature and / or does not exceed a predetermined threshold. The scleral shield 300 may further include an image converter 155 integrated into the scleral shield to allow viewing of the meibomian glands behind the eyelid. Figure 8 The eye treatment device 200 preferably also includes a power module 110 and optionally a controller 212, as well as other components described with respect to the various embodiments presented herein. In addition, Figure 8 The eye treatment device 200 includes a reflector 210. In the depicted embodiment, the reflector 210 is formed by a lens barrel and a back plate, which together surround all of the energy converter module 120 except in the distal direction.

[0170] Various embodiments of eye treatment device 200 also include one or more thermal management structures configured to cool at least a portion of the device. In some embodiments, these thermal management structures are configured to manage the heat of energy converter module 120 and prevent overheating of eye treatment device 200. Additionally or alternatively, in some embodiments, these thermal management structures are configured to cool the surface of the eyelid to limit discomfort and avoid injury to eyelid tissue during treatment. Figure 8 In, for example, the 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 thermally conductive surfaces for passive or active cooling. In some embodiments, a passive heat sink may be provided as an appropriate thermal management structure 220 to dissipate heat from the energy converter module 120 to the surrounding environment without the need for a thermoelectric module 224. Some embodiments include a thermoelectric module 224 or other type of cooler (e.g., a compact vapor compression cooler) designed to cool the energy converter module 120 by directing heat away from the energy transfer surface 140. In Figure 8In the embodiment, the thermoelectric module 224 and the thermal management structure 220 are coupled so that the thermoelectric module 224 pumps heat away from the energy converter module 120 toward the thermal management structure 220 for heat dissipation. Additionally or alternatively, some embodiments include one or more thermally conductive surfaces. For example, in Figure 8 In the embodiment of the present invention, the lens barrel and back plate of the reflector 210 are thermally conductive and are connected to both the energy transfer surface 140 and the thermoelectric module 224. In addition, the energy transfer surface 140 is thermally conductive. Therefore, the heat from the eyelid surface and the energy transfer surface 140 can be pushed to the thermoelectric module 224 to help maintain a comfortable temperature on the eyelid. Active cooling of the energy transfer surface 140 can occur not only during the thermal treatment period, but also before, after or intermittently as a means of cooling the eyelid. Such a feature can not only relieve the burning and itching sensations often associated with MGD and blepharitis, but also reduce inflammation of the eyelid.

[0171] In some embodiments, eye treatment device 200 includes a non-contact temperature sensor 232, which may be used, for example, in conjunction with one or more thermal management structures. Non-contact temperature sensor 232 may be an IR remote reading thermometer or other suitable temperature sensor. Non-contact temperature sensor 232 may be focused on an area of ​​the eye of particular interest. For example, Figure 8 , the non-contact temperature sensor 232 is focused on the bottom edge of the cornea and thus provides a reading of the temperature at the edge of the cornea. The non-contact temperature sensor 232 can be operably coupled to the controller 212 such that, in some embodiments, the controller 212 modulates or shuts down the energy converter module 120 or activates one or more thermal management 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 can 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 directly behind the portion of the eyelid being heated. In this way, the eye treatment device 200 can continue to heat the eyelid while periodically ensuring that the eyeball is not overheating. It should be appreciated that the eye treatment device 200 can be enabled, for example, by reversing the orientation of the energy delivery element while maintaining the display 244 and alignment element in their straight (readable) orientation. Figure 8 The device configuration shown is readily adapted for treating the upper eyelid.

[0172] Fig. 9 A side view of another embodiment of an ocular treatment device 200 having one or more thermal management structures 220 is depicted. Figure 8 or Fig. 9Any of the thermal management structures 220 described are suitable for use with any of the eye treatment device 200 embodiments described herein and are expressly contemplated for use therewith. The thermal management structures 220 may include any of the following suitable structures: configured to remove heat from the energy converter module 120 so that the energy converter module 120 remains within a desired temperature range to maintain the efficiency of the energy converter module 120. In some embodiments, the thermal management structures 220 are at least partially disposed within the housing 202 of the eye treatment device 200 along with the power module 110 and other internal components. In some embodiments, one or more of the following thermal management structures 220 are disposed within the housing 202: a heat sink ( Figure 8 finned heat sink embodiment of the thermal management structure 220 shown), thermoelectric (Peltier) modules (e.g., Figure 8 Thermoelectric modules 224), compact vapor compression modules, and fans. In some embodiments, thermal management structure 220 directs and distributes heat in a manner that housing 202 is cool to the touch.

[0173] In addition, in some embodiments, the eye treatment device 200 includes a surface cooling system designed to prevent the eyelid surface from being heated to the point of being thermally heated or injured while the target tissue below 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 wavelength light energy that is absorbed into the target tissue area within the eyelid or in the energy absorbing portion of the scleral shield, while heating the eyelid surface tissue is minimized. In embodiments where a surface cooling system is present, the surface cooling system can be configured to cool the surface of the patient's eyelid to or below body temperature or below the target tissue temperature or below the discomfort threshold before, during, or after delivering energy to the target tissue area. The surface cooling system can include any suitable structure configured to cool the eyelid surface and / or cool the energy transmission 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 transmission surface 140 is shaped so that there is an air gap between the energy transmission surface 140 and at least a portion of the eyelid. Figure 2B An embodiment appropriately configured for this purpose is depicted. In such an embodiment, air can be blown over the surface of the eyelid within the air gap. In other embodiments, the energy transfer surface 140 can have one or more holes or channels extending through or along the energy transfer surface 140 through which the air can be blown. In some embodiments, the air is cooled before being blown over the surface of the eyelid. The air can be cooled, for example, using a thermoelectric cooler, a compressor, ice, or other refrigeration element.

[0174] In other embodiments, an evaporative agent (such as water or alcohol) may be applied to the energy transfer surface 140 so that the surface of the eyelid is then in contact with the evaporative agent. Additionally or alternatively, the evaporative agent may be applied to the eyelid surface before, during, or after treatment with the eye treatment device 200. As the evaporative agent evaporates on the eyelid surface, the patient may feel a cool and soothing sensation. In still other embodiments, the eye treatment device 200 may include a cooling bladder positioned between the energy transfer surface 140 and the eyelid surface. The bladder may be filled with cold water or gel and provide a cool and soothing sensation to the patient when the bladder is in contact with the eyelid surface. As another non-limiting example, the surface cooling system may include the energy transfer surface 140 itself. In some such embodiments, the energy transfer surface 140 may be formed of an energy absorbing material such as diamond, sapphire, calcium fluoride, or graphene, and may be thermally linked to a larger thermal mass. Such a large thermal mass takes a long time to heat up, and therefore may not be significantly heated during the treatment period. Therefore, the large thermal mass may dissipate heat away from the energy transfer surface 140 during the treatment period. Additionally, the large thermal mass may be cooled before or during a treatment period and may also be formed from the same material as and as part of the energy delivery surface 140, or may be formed as a separate element without materials such as copper, aluminum, or other energy absorbing or conducting materials.

[0175] In addition to the thermal management structures 220 and surface cooling systems described above, at least some ocular treatment devices 200 include one or more safety sensors 230, for example, to monitor parameters of the ocular treatment device 200 or to ensure patient safety. Fig.10 An example of an eye treatment device 200 having one or more safety sensors 230 is provided. Fig.10 Any of the safety sensors 230 and associated controllers 212 described are used with any of the eye treatment device 200 embodiments described herein. Any particular eye treatment device 200 may include one or more types of safety sensors 230. Fig.10A first set of safety sensors 230 provided in are configured to sense temperature. Such safety sensors 230 include a non-contact temperature sensor 232 and a thermocouple or thermistor 234. The non-contact temperature sensor 232 may be an IR remote reading thermometer (such as a thermopile or pyroelectric material or a 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 to monitor the surface temperature of one or more eyelids during a treatment period, for example, 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 configured 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 and damaged, for example Figure 8 Depicted.

[0176] Additionally or alternatively, some embodiments include a thermocouple or thermistor 234 (or RTD) positioned on or near the energy converter module 120. Such placement allows the thermocouple or thermistor 234 to detect the temperature of the energy converter module 120, so that the temperature of the energy converter module 120 can be monitored. If the energy converter module 120 runs too hot, it may become inefficient and / or damaged. Additionally or alternatively, the thermocouple or thermistor 234 can be arranged on, within, or adjacent to the energy transfer surface 140. Such placement allows the thermocouple or thermistor 234 to detect the temperature of the energy transfer surface 140 and / or the eyelid surface. Monitoring the temperature of such surfaces can help ensure that the patient does not experience significant discomfort or injury due to the use of the eye treatment device 200. In some embodiments, a plurality of different temperature sensors 232, 234 are operatively connected to the controller 212, which can be programmed to modulate the output of the energy converter module 120 or one or more thermal management structures or surface cooling systems to keep the temperature within or within a predetermined target range. Furthermore, if the temperature input of the temperature sensors 232, 234 is above a predetermined range, the controller 212 can shut down the output of the energy converter module 120. Additionally or alternatively, the temperature sensors 232, 234 can be coupled to the scleral shield 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, one or more pressure sensors 221 can be disposed on, within, or adjacent to the scleral shield 300 and / or the energy transmission surface 140 to monitor the pressure or force applied by the user to the eyelid.

[0177] Exists in Fig.10A second set of safety sensors 230 in are provided for sensing the position of the eye treatment device 200 relative to the patient's eyelids. Light sensors 236 present in, on, or near the energy transfer surface 140 are configured to detect light. In a variety of different configurations of the eye treatment device 200, when the energy transfer surface 140 is properly placed adjacent to one or both eyelids, depending on the configuration, the amount of ambient light that can reach the light sensors 236 is significantly reduced. In some embodiments, if light above a threshold range is detected in, on, or near the energy transfer surface 140, it indicates that the energy transfer surface 140 is not properly placed. Similarly, contact sensors 238 can be present in or on the energy transfer surface 140. Each contact sensor 238 can be configured to detect a change in capacitance, such as a change in capacitance that occurs when the contact sensor 238 is close to human skin. Alternatively, the contact sensor 238 can include an electrode that applies a small DC or AC microcurrent and senses the impedance change caused by contact with the skin. Alternatively, contact sensor 238 may include a microswitch or a force or pressure sensor, all of which produce a change in a signal characteristic when energy transfer surface 140 is against the skin. Thus, sensor 238 may be used to help determine placement of eye treatment device 200. If eye treatment device 200 is properly placed on a closed eye, upper contact sensor 238 and lower contact sensor 238 should each be in contact with the skin of the eyelid and sense a change in capacitance (or impedance, switch state, force, pressure, etc.). In various embodiments, light sensor 236 and / or contact sensor 238 are operatively coupled to controller 212. In some such embodiments, controller 212 is programmed to prevent energy converter module 120 from being activated until controller 212 detects, via signals from sensors 236, 238, that eye treatment device 200 is properly placed adjacent to a closed eye. Furthermore, in some embodiments, the controller 212 is programmed to deactivate the energy converter module 120 when the signals received from the sensors 236, 238 indicate that the eye treatment device 200 is no longer properly placed on the closed eye. Additionally or alternatively, a thermocouple or thermistor 234 on, in, or adjacent to the energy transfer surface can be used to indicate that the device is properly positioned adjacent to the patient's eye. For example, the thermocouple or thermistor 234 can record the room temperature before the device is placed adjacent to the eye, and as the energy transfer surface 140 comes into contact with the eyelid skin (in embodiments where direct contact is desired), the thermocouple or thermistor 234 records a value closer to body temperature and thus confirms proper positioning. Additionally, if multiple thermocouples are used in embodiments that treat both the upper and lower eyelids, data from the thermocouple or thermistor 234 can be used to determine whether the eye is open or closed. A reflectance or color sensor 237 can also be incorporated into the device to confirm that the eye is closed.Such a sensor 237 may determine the color of the light field area in front of the sensor 237, or it may determine the degree of reflectivity of a surface in front of the reflective or color sensor 237. In either case, the sensor 237 provides data indicating whether there is tissue that looks like eyelid skin (e.g., flesh-colored and not moist or shiny) or eye tissue (white or iris-colored and moist and shiny).

[0178] In some embodiments, the contact sensor 238 comprises a microswitch embedded behind a flexible sealing surface. In other embodiments, the contact sensor 238 comprises a sensor that provides an indication of the amount of force or pressure applied by the energy transfer surface 140 on the eyelid. Such an indication can be useful to avoid applying too much force during treatment, or to apply a range of forces during initial diagnosis when the eyelid is to be slightly compressed to enable assessment of meibomian gland secretions. It should be understood that the force applied by the clinician to one or more eyelids via the energy transfer surface 140 can be adjusted or not. Additionally, in an in-office device, a force having a roll component or an angular component can be applied to assist in the removal of meibum from the meibomian glands and ducts. In some embodiments, the energy transfer surface and / or the scleral shield can have a curved or angled surface, or can have a rocking element, such that when the energy transfer surface compresses the eyelid against the shield, there is initially more compression in the lower region of the meibomian gland, which gradually transfers to the upper region as the compression increases, thereby moving the meibum from the lower region to the upper region and then out of the meibomian gland duct.

[0179] Fig.11A and Fig. 11B A side view of an additional embodiment of an eye treatment device 200 having an energy converter 205 configured to convert electrical energy from the power module 110 into ultrasonic energy is depicted. The ultrasonic energy converter 205 may be formed of any suitable material, such as piezoelectric ceramics, polymers, or composite materials. In the various embodiments described above, the ultrasonic energy converter 205 may be used in conjunction with the optical energy converter module 120.

[0180] exist Fig.11AIn the embodiment of the present invention, the eye treatment device 200 includes a flat piezoelectric ultrasonic energy transducer 205 configured to emit unfocused ultrasonic waves. When the direction of the wave is unfocused, the wavelength of the ultrasonic energy can still be manipulated to target specific areas of tissue. With 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-range or single value therebetween are emitted. Ultrasonic waves of this frequency can penetrate 1-3 mm into the eyelid tissue. Advantageously, at this penetration depth, the meibomian glands and other surrounding target tissues can be heated without significant heating within the eye. In other embodiments, wavelengths greater than 100 MHz can be emitted from the ultrasonic energy transducer 205.

[0181] Fig. 11B The eye treatment device 200 includes one or more curved piezoelectric ultrasonic energy transducers 205 configured to generate focused ultrasonic waves. In some embodiments, the ultrasonic waves are directionally focused to selectively heat a target tissue region to a degree sufficient to melt meibum within a meibomian gland located within or adjacent to the target tissue region. In some such embodiments, the ultrasonic waves are directed and guided by using a shaped or curved transducer with a focus. Fig. 11B One such embodiment is depicted. In other embodiments, a shaped array of independent ultrasonic elements is used to direct and guide the ultrasound waves. There may be more than one array of ultrasonic elements; for example, one array is directed to the lower eyelid, while another array may be directed to the upper eyelid. It should be understood that in order to effectively transfer ultrasonic energy to the target tissue, the energy transmission surface 140 must be made of an appropriate material. For low-frequency ultrasound, conventional materials such as silicone or other polymers and elastomers can be utilized. In certain embodiments, it may be desirable to cool the surface of the eyelid when the ultrasonic energy is applied to prevent exceeding a predetermined threshold. In such a case, the energy transmission surface 140 can be made of a material that not only allows ultrasonic energy to pass through but is also thermally conductive (so that the cooling techniques described earlier in this article can be applied). Examples of materials that allow high-frequency ultrasonic energy to pass through and provide appropriate thermal conductivity include diamond or graphene.

[0182] It will be appreciated that in addition to providing tissue heating, ultrasound may also disrupt, destroy, or even kill the previously mentioned Demodex mites. As such, it may be beneficial to combine energy modalities such as light and ultrasound to achieve optimal overall treatment of MGD, blepharitis, and related conditions.

[0183] In addition to heating the target tissue area, some embodiments of eye treatment device 200 may also be configured to send vibrational energy to a region including the target tissue area. Fig.12An example of an eye treatment device 200 configured to generate vibrational energy is provided. Fig.12 The described vibration mechanism 250 embodiments are used with any of the eye treatment device 200 embodiments described herein. Fig.12 The eye treatment device 200 includes a vibration mechanism 250 within a portion of the housing 202. Any suitable vibration mechanism 250 may be used. In a number of different embodiments, the vibration mechanism 250 is configured to produce a specific vibration pattern. For example, when held on the patient's eyelid, the eye treatment device 200 having the vibration mechanism 250 can vibrate forward and backward along an axis parallel to the central eye axis 30. In other embodiments, the eye treatment device 200 can vibrate left and right or up and down in a direction orthogonal to the central eye axis 30. In still other embodiments, the eye treatment device 200 can vibrate in a circular pattern, such as a circular pattern orthogonal to the central eye axis 30. In some embodiments, the eye treatment device 200 can include a variety of settings so that multiple vibration patterns can be selected. The vibration pattern can be applied to the eyelid before, during, or after delivering heat to the target tissue area.

[0184] In some embodiments, the vibration frequency is between about 1 Hz and about 20 KHz, but can be extended to the ultrasonic frequency range up to 20 MHz, and can include any sub-range or single value therebetween. Vibration in this frequency range can help discharge thickened or blocked meibum within the meibomian glands. In addition, the vibration mode can disturb or destroy Demodex mites, thereby reducing their proliferation. It should be understood that a combination of vibration and / or ultrasonic energy application can be used to generate the most effective overall treatment, including tissue and meibum heating, meibum vibration and discharge, and mite destruction.

[0185] like Fig.12 As further depicted in FIG. 2 , in some embodiments, the vibration mechanism 250 is positioned in the distal portion 203 of the housing 202. In some such embodiments, a vibration blocking element 252 is positioned between the distal portion 203 of the housing 202 and the proximal portion 201 of the housing 202 so that the force of the vibration is dampened in the proximal portion 201. In some embodiments, the handle or hand grip portion of the eye treatment device 200 is located in the proximal portion 201; thus, during use, the vibration blocking element 252 helps limit vibrations in the user's hand. In other embodiments, the blocking element 252 is not present. In still other embodiments, the vibration mechanism 250 is disposed within the proximal portion 201 of the housing 202 with a translation link between the vibration mechanism 250 and the distal portion 203.

[0186] It should be emphasized that the foregoing specific embodiments are exemplary, and that the present disclosure encompasses numerous variations beyond those specific embodiments. Some of these will now be described in more detail.

[0187] When the energy converter module 120 is an LED emitter 207, some embodiments include using one or more LEDs that preferably have high intensity. For example, the combined power output of the one or more LEDs is at least 10 watts, preferably at least about 15 watts, or even 20 watts or more. The combined intensity of these LEDs can advantageously be at least about 20, 30, 40, 50, 75, 100, 150, 200, 250, 300, 400, 500, 1000, 2000 or more lumens. When directed at the eyelid, the continuous intensity of the applied luminous energy can preferably be between about 0.02 and 2 watts / cm2.

[0188] In some embodiments, the LED can be a green LED. Green is advantageous because it penetrates and heats tissue to a depth of about 0.5-2mm, beyond which it will significantly attenuate. This allows light energy to penetrate the treatment area of ​​tissue contained at or adjacent to the meibomian gland, with limited light transmission to the eye. Some preferred wavelengths of light can be 495-570nm, 500-600nm, and more preferably about 510-540nm or 520-530nm. In some embodiments, the infrared radiation source can be 700-1000nm, preferably about 800-900nm in the "optical window" of human tissue, and more preferably about 850nm. Longer wavelengths will also work, and as the wavelength increases, more absorption of water in the tissue may be utilized. For example, 3,000nm infrared may be able to provide ideal heating of eyelid tissue, with penetration and heating of the eyeball and sensitive structures minimized. In other embodiments, the LED can be blue, yellow, red, white, or any combination of the foregoing.

[0189] The energy converter module 120 may alternatively include a broad spectrum or a narrow spectrum, such as an incandescent lamp, a xenon lamp, a halogen lamp, a cold cathode tube, a fluorescent tube, etc. The illumination source may further include a spectrum limiting element to reduce certain undesirable wavelengths in the spectrum of the lamp or significantly eliminate certain undesirable wavelengths therefrom. These spectrum limiting elements may include color filters, dichroic filters, IR cut-off filters, gratings, bandpass filters, spectrum separation elements, such as prisms or gratings, etc. Infrared lamps or heating elements may also be used. The main wavelengths allowed to reach the eyelids may be selected as discussed above for LEDs, or may be limited primarily to infrared radiation.

[0190] The energy emitted by the illumination source and delivered to the patient is preferably continuous in delivery (with pulse width or other forms of modulation if desired), as compared to low duty cycle, high intensity pulsed light (e.g., IPL). The treatment period is preferably 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.

[0191] In some embodiments, visible light delivery by the energy converter module 120 may be facilitated or replaced by alternative energy converters used as a heating modality. These may include, for example, ultrasonic converters or radio frequency transmitters. When an ultrasonic converter is used, it may be focused or unfocused. High frequencies are preferred to limit the depth of heating, concentrate heating on a target tissue area including or adjacent to the meibomian glands, and reduce or eliminate effects on the eyeball or other tissues in the area. Preferred frequencies are 50-100 MHz or greater than 100 MHz to 250 MHz. Particularly preferred are focused ultrasound, for example using multiple converters, which include phase management arrays to facilitate directional focusing, or shaped transducers with limited focal areas. As with light energy, relatively continuous delivery may be used, as well as pulsed delivery.

[0192] When a radio frequency transmitter is used, a frequency known to provide localized heating is preferred. Advantageously, frequencies used for electrosurgery, such as 300 KHz-4 MHz, may be used. In one such embodiment, bipolar electrodes are provided in or on the energy delivery surface 140 to contact the eyelid and permit control of the location and depth of heating.

[0193] Alternatively, higher frequency radio waves in the 5 MHz to 10 MHz range may be used due to their higher attenuation rates in tissue, thus allowing careful selection of penetration depth to the desired tissue area and limiting heating thereof. For example, frequencies above about 245 MHz penetrate human skin and tissue to a depth of about 1-3 mm, which matches the typical distance between the outer part of the eyelid and the target tissue (i.e., the meibomian glands and adjacent tissue).

[0194] The energy waveguide module 130 is designed to transfer energy from a converter or transmitter to the energy transfer surface 140 and thereby to the target tissue. For example, when light energy is generated from a small source, such as an LED or a small lamp, the energy waveguide module 130 can guide uniform illumination from the source to the target tissue area. In some embodiments, it may be desirable to include a waveguide structure for directing light to the eyelid and target tissue without directing it along the central eye axis of the eye. Then, this can reduce the amount of light penetrating the cornea and the eye, while still directing the light to the eyelid, although the tangential angle is larger. Suitable structures for achieving this purpose include light pipe arrays, refractive elements, reflective elements, diffractive elements, total internal reflection elements (TIR) ​​and diffusers. For example, it may be suitable for optical fibers, mirrors, lenses, prisms, etc. to guide light and change its incident angle to the target surface (e.g., avoiding the central eye axis). In some embodiments, it may be desirable to direct light to the scleral shield 300 and the image converter 155 to view the inside of the eyelid 14 and / or heat the meibomian glands behind the eyelid, as described above.

[0195] In another embodiment, the energy waveguide module 130 is an ultrasonic waveguide having a surface that reflects ultrasonic energy to direct and / or focus it to a desired area, such as a target tissue area. Similarly, microwave or other RF waveguides of known design may be used to direct RF energy to a desired area.

[0196] The energy transmission surface 140 is between the interior of the eye treatment device 200 and the patient, thereby providing a barrier therebetween. In some embodiments, it can be envisioned as a window through which energy is delivered to the patient. The barrier can be configured to directly contact the patient's eyelid during treatment, or to be spaced a small distance from the eyelid, such as 0.5 mm to 12 mm from the eyelid. Preferably, the outer surface of the energy transmission surface is smooth and easy to clean. In some embodiments, a disposable eyelid outer pad 147 can be placed on the energy transmission surface 140 to prevent cross contamination between patients. The eyelid outer pad 147 can be made of any suitable material, such as glass, Pyrex glass, quartz, mica, or a polymer (such as polycarbonate), or other optically transparent materials, or combinations thereof, can be used to obtain the desired structural and optical properties. In some embodiments, the energy transfer surface 140 can be in a slidable relationship relative to the energy converter module 120 or the scleral shield 300 or the housing 202 along the movement path 145 to ensure that the energy transfer surface 140 can be pressed against one or more eyelids to a) minimize photon energy leakage during treatment and imaging, and b) if necessary, apply compression to the eyelids during assessment or drainage of the meibomian glands.

[0197] When light energy is used to heat the target tissue area, the energy transmission surface 140 is advantageously transparent to visible or infrared light as desired. In some embodiments, the energy transmission surface is transparent to the peak or desired wavelengths for treatment (such as visible 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.

[0198] When ultrasound or RF is used to heat the target tissue area, it is not necessary to be transparent to visible light; instead, ultrasound transparent or RF transparent materials can be used. In some embodiments, it is desirable that the material is thermally conductive to facilitate cooling the eyelid by cooling the energy transmission surface 140. Diamond, sapphire and graphene are suitable thermally conductive materials. In another embodiment, the entire energy transmission surface 140 or at least its window is transparent to the safety sensor disclosed herein. For example, in the case of using a non-contact infrared temperature sensor to sense the temperature outside the eyelid, it is advantageous to use IR transmissive materials for all or at least one or more relevant areas of the energy transmission surface 140.

[0199] When heating energy is applied to the eyelid from the ocular treatment device 200, some embodiments include surface cooling of the eyelid by cooling the energy delivery surface 140. Patient comfort can be enhanced while maximizing efficacy by optimal heating of the target tissue if the exterior of the eyelid is cooled while irradiating the target tissue area with light energy, ultrasound energy, or RF energy. The energy delivery surface 140 can be cooled by passing an airflow through the interior of the energy delivery surface 140; applying an evaporative agent, such as a refrigerant or water, to the inside of the energy delivery surface 140; circulating a cooling fluid through channels in or on the energy delivery surface 140; or contacting the energy delivery surface with a thermoelectric (Peltier junction) or heat sink linked to a cooling modality. Alternatively, the energy delivery surface 140 can have a sufficiently large thermal mass (or be in contact with such a thermal mass) to remove sufficient heat from the eyelid during treatment of the patient to maintain the eyelid within a desired temperature range. The thermal mass can be pre-cooled prior to treatment, or simply started at ambient temperature. Other methods of cooling the energy delivery surface 140 and / or the eyelid include incorporating a reservoir, such as a water-filled bladder, between the energy delivery surface and the eyelid skin. The bladder may be pre-cooled or actively cooled during a routine, such as by circulating cold water through it or by using a cooling element, such as a thermoelectric device, compressor, refrigerant, or other cooling element.

[0200] In another embodiment, the energy transfer surface 140 is spaced a small distance from the eyelid, and a cooling fluid (such as relatively cold air, mist, water, etc.) is allowed to pass between the energy transfer surface 140 and the eyelid. For example, cool air can be induced to flow laterally across the surface of the eyelid and the energy transfer surface 140, or the energy transfer surface 140 can include holes or channels for directing the cooling fluid to the eyelid. The cooling fluid can be ambient temperature or can be pre-cooled, such as by refrigeration, ice, etc.

[0201] When a vibration mechanism 250 is used, the vibration mechanism may include, for example, a reciprocating element (such as an electromechanical solenoid, etc.), a rotating eccentric weight (such as an eccentric weight coupled to a motor shaft), or a rotating cam. Preferably, the vibration mechanism is vibrationally coupled to the eyelid, but vibrationally blocked from other points of contact with the patient or clinician (such as the proximal end of the ocular treatment device 200, including any handle area that the patient or clinician may grasp).

[0202] In the present device and method, the safety and comfort of the patient are important considerations. Therefore, safety sensors and warnings can be advantageously incorporated into the device. These sensors and warnings include sensors for preventing skin overheating, sensors for preventing the device from being activated unexpectedly, and sensors for monitoring energy delivered to the patient. In some embodiments, safety sensors can be used to ensure that the consumables portion 260 with the protective scleral shield 300 is in the correct position before turning on the energy converter module 120, thereby preventing damage to the eye system 10.

[0203] like Fig.10 As shown, a safety warning device 240 may be incorporated into the device to inform the patient of an unsafe condition sensed by any sensor as described herein. This may include a flashing light, a flashing warning, an audible warning beep, a picture, a vibration pattern, or text indicating a potential or existing unsafe condition.

[0204] See again Fig.10, the first set of safety sensors 232, 234 are preferably positioned on, in, behind, or otherwise near the energy transfer surface 140. The two sensors are configured to detect heating of the outer surface of the eyelid and prevent overheating thereof. Sensor 232 is preferably a non-contact sensor, such as a thermoelectric sensor (e.g., IRA-E700ST0 from Murata, Japan), or a thermopile (e.g., ST25T0-18 from Dexter Research, Michigan), or a conventional temperature monitoring device (such as a thermocouple, thermistor, fiber optic thermal sensor, or digital temperature sensor (e.g., Dallas Semiconductor DS-18620). In addition to temperature sensors 232 and 234, temperature sensors 310 may also be mounted on the front and back surfaces of the scleral shield 300, as shown in FIG. 3, 7A to 7H and Figure 8 As shown, it is used to monitor the inner surface temperature of the eyelid and the temperature of the eyeball, respectively. A threshold temperature, such as 40°C, 45°C, or 50°C, can be programmed in the eye treatment device 200. In some embodiments, when the threshold temperature is reached or exceeded, the safety sensor can be configured to deactivate the eye treatment device 200, and / or use a light, a buzzer, or other notification means to send a signal to the user or clinician to stop treatment via the safety warning device 240. In some embodiments, when the threshold temperature at any particular location is reached or exceeded, the controller 212 (or a discrete circuit system independent of any controller) can be used to prevent the eyelid from being heated above the threshold temperature. This can be achieved, for example, by: deactivating the eye treatment device 200; reducing the energy delivered (such as reducing the intensity of the light, the pulse width modulation of the LED, reducing the power input of the ultrasonic energy or the RF energy, etc.), or activating cooling measures to reduce the temperature of the eyelid.

[0205] Fig.10A second type of safety sensor is also shown in FIG. It may include a single sensor or multiple sensors. The purpose of the second type of safety sensor is to ensure that the eye treatment device 200 is properly positioned on the eyelid before activating the treatment. The second type of safety sensor may include one or more of the following sensors. One sensor may be a light sensor 236. When the device is positioned on the eyelid, ambient light will be blocked. Therefore, the absence of such light can be detected. Alternatively, a reflective light coupler type device may be used, in which the light source is directed distally and coupled to a sensor that is also aimed distally. This allows the presence of the patient and an approximation of the distance to the patient to be detected. When the eye treatment device 200 is properly positioned, light detection is maximized or eliminated depending on the distance between the light source and the light coupler type device. Another light detection scheme is to have the light sensor 236 face distally toward the patient, but outside the path of the treatment light. When the eye treatment device 200 is spaced apart from the eyelid, the reflected treatment light can reach the sensor 236, but when properly positioned, most of such light is blocked by the sensor 236. The light sensor approach can be coupled with data from a temperature sensor to simultaneously detect light and skin temperature as an indication of device positioning. In any light detection embodiment, an ambient light sensor 236 can be incorporated into the eye treatment device 200 for measuring ambient light levels, thereby facilitating optical detection of proximity to the eyelid. Similarly, when a temperature sensor is used in conjunction with a second type of sensor, the ambient light sensor 236 can facilitate determining when the eye treatment device 200 is against the skin, especially in a high temperature environment. Other distance or contact detection elements, such as ultrasonic ranging modules, can also be used. In some embodiments, a thermocouple or thermistor 234 on, in, or adjacent to the energy transmission surface can be used to indicate that the device is properly positioned adjacent to the patient's eye. For example, the thermocouple or thermistor 234 can record the room temperature before the device is placed adjacent to the eye, and as the energy transmission surface 140 approaches the eyelid skin, the thermocouple or thermistor 234 records a value closer to body temperature and thus confirms proper positioning. A reflective or color sensor 237 can also be incorporated into the device to confirm that the eye is closed. As described above, such a sensor 237 may provide data indicating whether there is tissue that looks like eyelid skin (e.g., flesh-colored and not moist or shiny) or eye tissue (white or iris-colored and moist and shiny).

[0206] In another embodiment, the second type of sensor can be a touch sensor for detecting when the eye treatment device 200 touches the face. The touch sensor can be a resistive sensor that utilizes two electrodes and senses microcurrents passing through the skin, or a conventional resistive touch sensor. Alternatively, a capacitive sensor can be used to detect when the eye treatment device 200 touches the skin. The capacitive sensor can be a single sensor or multiple sensors (in order to obtain a better signal), where all or some of the sensors must be activated to allow treatment to proceed. Finally, the touch sensor can 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 can be embedded behind a flexible sealing surface, or can be activated when sufficient pressure is applied to allow the first part of the eye treatment device 200 to move relative to the second part of the eye treatment device 200.

[0207] A third type of safety sensor may also be used in eye treatment device 200 to monitor the energy delivery transducer to ensure proper operation within predetermined parameters. Again, this may be a single sensor or a combination of sensors including one or more of the following. In some embodiments, the safety sensor may measure the amount of energy applied to the transducer (e.g., Fig.10 The current and / or voltage of the converter (shown as converter monitor 246) may be monitored. Thus, when the converter is one or more LED transmitters 207, the drive current or forward voltage of the LED may be monitored, where deviations from pre-established parameters may indicate an LED or LED driver failure or unsafe operating condition. Similarly, the voltage across the RF or ultrasonic converter may be monitored by the converter monitor 246, and the current provided thereto may also be monitored. In another embodiment, in Fig.10 A thermal sensor (such as a thermocouple or thermistor 234) shown adjacent to the energy converter module 120 may be configured to monitor internal or external temperature of the converter components, where overheating may indicate unsafe operation or component failure, and lack of heating may also indicate an operational failure.

[0208] In some embodiments, the controller 212 can be a manual or open-loop system without any automatic control, with autonomous discrete analog and digital circuit systems for manual operation. Manual operation can include turning the eye treatment device 200 on and off and receiving safety and feedback information. In this case, without the need for a controller, the user or clinician turns on the eye treatment device 200 and uses feedback to evaluate the desired treatment of the eyelid and adjusts the process in response to the evaluation, thereby manually operating the eye treatment device 200. The feedback feature can send the following signals to the user or clinician: status (e.g., on / off), lights or beeps, temperature data, pressure data, safety data, or other data that can help the user or clinician evaluate the process. In some embodiments, for safety, the controller 212 may include a direct-acting threshold detector and a deactivation circuit. In some embodiments, the controller 212 may include a processor or central controller that is configured to monitor the controller through feedback features and, for safety, return a portion of the feedback to the controller, such as shutting down the system in an unsafe condition.

[0209] The controller 212 functional block covers and executes both the operation function of guiding the given operation and the safety function and interfaces with each safety sensor 230. The controller can be a single processor that controls all functions, i.e., as shown in FIG. Figure 4A One controller 212 is shown; or two or more controllers may be included, such as a primary controller with a secondary safety controller that acts as a monitor on the primary controller, as is well known to those skilled in the art. Specifically, the secondary safety controller may be designed to monitor the function of the primary controller, and if one or more parameters indicate that the controller 212 may not function properly, the secondary safety controller is configured to shut down the energy converter and / or the entire eye treatment device 200. The functions associated with the controller 212 may be implemented with a controller with associated software, such as a microprocessor or microcontroller, but certain embodiments may preferably operate without a controller and instead utilize one or more of the following: a programmable gate array, a logic array, an analog circuit system, a digital circuit element, or any combination of the above.

[0210] In a simple embodiment, the secondary safety controller comprises an array of analog or digital circuit elements without a processor. For example, optical, temperature and / or pressure switches hardwired together or in conjunction with logic circuitry, operational amplifiers and / or relays are configured to allow initial or continued operation of the device only when the sensors are in a predetermined state. In an alternative embodiment showing full processor control, all sensors are monitored by digital or ADC inputs to one or more programmed processors to perform the functions of the secondary safety controller and prevent operation beyond predetermined parameters or modulate the operation of active elements in the ocular treatment device 200 to remain within those parameters.

[0211] In addition to safety functions, controller 212 may direct normal operation of eye treatment device 200. For example, it may interact with a user through user interface 270, which may include control buttons, a rotary encoder, a touch screen, voice commands, or any other conventional user interface. It may control a power manager; direct or interrupt current flow to an energy converter and modulate its output; start or stop operation of a vibration device; start or disable a safety warning; start, modulate, or stop operation of a surface cooling device; and monitor and modulate cooling of the energy converter through a thermal manager. Controller 212 or a discrete power substitute may be operatively linked to some or all of these systems within eye treatment device 200. In addition, it may include a timer function to automatically deactivate the energy converter and thereby interrupt delivery of heating or vibration energy to the eyelid after a predetermined period of operation or in response to a signal from a first type, a second type, or a third type of safety sensor.

[0212] The power module 110 is designed to facilitate powering the eye treatment device 200. The power module may include an external power interface, such as a cord or cable interconnected 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. This may include a nickel metal hydride battery, a lithium ion or lithium polymer battery, a nickel cadmium battery, or any other suitable rechargeable or non-rechargeable battery. The battery preferably provides a high current capacity, such as 1-5 amps, preferably at least 3 amps surge current, and is capable of delivering such high current for 1, 2, 3, 4, 5 or more minutes. In some embodiments, the internal battery delivers 3, 4, 5, 6, 7, 8, 9, 10, or 12 volts or more. The capacity of the battery is determined by the design load and can be, for example, a battery pack having a capacity of at least 200, 300, 400, 500, 1000, 2000, 2500 mA-hours or more. The desired voltage may be achieved by connecting lower voltage batteries in series to achieve the desired voltage or by using a DC:DC converter to step up the lower voltage to the desired voltage. In some embodiments, the battery provides a voltage lower than the voltage required by the energy converter power supply and steps up the voltage for the energy converter while providing a lower voltage (e.g., 5V or 3.3V) to the controller 212 or alternative separation circuitry.

[0213] In a preferred embodiment, the energy converter can be a high power LED similar to that manufactured by LED Engin; specifically, the energy converter can be an LZ9 configured with nine green emitters in a non-standard configuration arranged in three sets of three series emitters in parallel, requiring approximately 12-14V forward voltage and up to 2.4 amps of maximum illumination. In this embodiment, three RCR123 LiFePO4 batteries or the like can be utilized in series, with a capacity of 750mA-hours and providing a starting voltage of 7.2V. A DC-DC converter circuit is included that steps up the voltage by approximately two times to provide the voltage required to drive the LED.

[0214] Power management functions may include a charger, a battery status monitor, and / or a temperature monitor. These functions may be performed by separate circuitry, or may be incorporated in whole or in part into the controller 212. In some embodiments, power management includes a battery charger powered by an inductive coupling to an external power supply, which may allow the eye treatment device 200 to be sealed to allow for easy cleaning and to prevent the ingress of moisture or dust. In some embodiments, the inductive coupling may use a recharging cradle or an electrically isolated mains power connection. The inductive coupling may include two inductive coils in close proximity (one in the cradle and one in the device) or two coils tuned to resonate at the same frequency (resonant inductive coupling or electrodynamic induction).

[0215] Thermal management is also a key element of many preferred embodiments, and in some cases includes removing heat from the energy converter, such as an LED or LED array. In the case of an LED, it is important to maintain the junction temperature below a predetermined threshold (e.g., 135 degrees Celsius). Similarly, other converters have maximum allowable temperatures for components, and proper thermal management helps maintain these components within the allowable temperature. For example, a heat sink thermally coupled to the energy converter element, a fan, a heat sink, a cooling fluid, etc. may be utilized. In a preferred embodiment, the eye treatment device 200 is sealed, and as Fig. 9 The illustrated thermal management structure 220 directs excess heat to the outer surface of the ocular treatment device 200. This allows for a sealed device without vents. In other embodiments, cooling fluid is directed from a thermal manager within the device to cool the device, such as by forced air cooling (e.g., Figure 8 ) or a liquid cooling heat sink to remove heat from the device.

[0216] In further aspects of the technology, the eye treatment device 200 may include elements for calibrating the device to provide a desired amount of heating to the target tissue over a variety of ranges of eyelid thicknesses. This is important because without such calibration, the amount of heating that occurs at the target tissue area (e.g., meibomian glands and adjacent tissue) may vary unless the temperature near the target tissue area is measured during treatment. As previously discussed, monitoring of the target tissue area can be achieved through the use of a scleral shield equipped with a temperature sensor. However, it may be inconvenient for the user of the device to insert the scleral shield each time the device is used. Therefore, it may be useful to calibrate each device to the specific anatomy of an individual. To this end, the device can be initially calibrated using a scleral shield, preferably in the setting of an eye care professional's office and in combination with an external monitor and calibrator.

[0217] For example, see Fig.13As the eye treatment device 200 applies energy to the eyelid(s), the scleral shield 300 transmits temperature data (via a wired or wireless connection) to the external monitor and calibrator 500. The external monitor and calibrator 500 tracks the rate of temperature increase over time and thereby characterizes the heating curve of the patient's eyelid(s). Then, using this data, the external monitor and calibrator 500 can program the eye treatment device 200 to heat the target tissue to a desired temperature range. In a simple embodiment, the external monitor and calibrator 500 turns on the energy converter, measures the amount of time required for the target tissue to reach the desired temperature, and then turns off the energy converter and programs the eye treatment device 200 to apply energy for the same amount of time. Alternatively, the eye treatment device 200 can be programmed to provide increasing or decreasing amounts of energy to heat the target tissue to a desired temperature within a preferred time period. In most individuals, the thickness of the eyelids is similar from the upper eyelid to the lower eyelid and from the right eye to the left eye, however, it should be understood that the external monitor and calibrator can individually measure and individually program the device to apply a specific amount of energy to each eyelid to ensure that each eyelid is properly heated. It should be further understood that there may be differences in the performance of the components used to implement the energy converter and related circuit systems, and without proper calibration, one device may produce more or less energy than another device. One solution is for the factory to measure the actual energy output for a given command level of the controller, and incorporate a calibration table within the controller so that each eye treatment device 200 outputs an equal amount of energy for a given command level. Alternatively and in addition, using an external monitor and calibrator 500, such differences can also be compensated by the above-mentioned routine, where 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 on each specific patient (and optionally each specific eyelid) (regardless of component differences).

[0218] See now Fig.14A and Fig. 14B , in one embodiment of the scleral shield 300, an array of temperature transducers 310 is embedded in the shield. For the present application, in situations where the shield is not actually used to shield the eye from energy, but rather to measure temperature, the shield 300 can be made of a material that is substantially transparent to the energy emitted from the energy transducer. By way of specific example, if the energy transducer is a light source, the shield 300 can be made of a transparent material that can be passed through by the (multiple) wavelengths of light emitted by the energy transducer. Preferably, the shield 300 is also as thin and flexible as possible, and has no sharp features, so that it can be comfortably placed under the eyelid with minimal discomfort to the patient and, therefore, minimal effect on heating of the tissue. Fig.14A and Fig. 14BIn the illustrated embodiment, an embodiment is shown in which there is an array of six temperature sensors 310 on the front surface 302 of the shield 300 and an array of sensors on the back surface 304. This configuration allows the forward-facing sensors 312 to more directly measure the temperature of the tissue on the inner surface of the eyelid where the meibomian glands are located, while the rear-facing sensors 314 measure the temperature of the surface of the eye where the most sensitive tissue of the eye is typically located more directly along the midline of the central eye axis. The temperature sensors can be discrete components embedded in the shield 300 (such as thermocouples made of very fine wires, or micro-thermistors), or can be thermocouples formed by depositing appropriate metal films on an intermediate layer of the shield 300. In some embodiments, the preferred type of material for the shield 300 is a soft, flexible, biocompatible material, such as silicone, polyurethane, and various hydrogels similar to those used in contact lenses.

[0219] While the above embodiment describes a configuration with an external monitor and calibrator 500, it should be appreciated that the eye treatment device 200 itself may have the same capabilities built into it, in which case the scleral shield 300 communicates the temperature data directly to the eye treatment device 200, and the eye treatment device 200 programs itself to provide the correct treatment regimen for the particular patient (and optionally for each eye and eyelid). In such an embodiment, the eye treatment device 200 has a sophisticated user interface 270 to allow the clinician to command the eye treatment device 200 to perform a calibration sequence and optionally instruct the eye treatment device 200 as to which eyelid and / or eyelids are being calibrated. It should be appreciated that if the eye treatment device 200 is calibrated to provide individually calibrated treatment for each eye or eyelid, the eye treatment device 200 needs to be able to indicate to the patient (via a series of lights or an alphanumeric or graphical display) which eye or eyelid to treat next.

[0220] Alternatively or in addition, a calibration element may be used to measure the energy output of eye treatment device 200. For embodiments where the energy transducer is a light source, the calibration element may be a light meter to measure, for example, luminous flux, lumens, or radiant flux. For embodiments where 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 eye treatment device 200 is operating within acceptable limits, and may also provide data to allow adjustment of certain parameters (such as energy level or treatment time) to return eye treatment device 200 to a desired performance range. It should be appreciated that the calibration element may also communicate directly with eye treatment device 200 or indirectly with eye treatment device 200 (e.g., via a PC) to reprogram eye treatment device 200 with updated calibration data to keep the device operating within an acceptable performance range.

[0221] In some embodiments, the eye treatment device 200 may further include a temperature display feature or dashboard 218 for an in-office device that may include inner eyelid temperature and outer eyelid temperature. The temperature display feature may display absolute temperature, or only relative temperature with a maximum value. For example, the temperature may be displayed in a bar graph format, or displayed with one or more lights.

[0222] In some embodiments, the eye treatment device 200 may further include a data logger 214 configured to record various aspects of the treatment (e.g., time, date, usage parameters, temperature, photos, videos, etc.). In some embodiments, the eye treatment device 200 may further include a voice recorder 213 so the clinician can verbally record observations about whether the various MGs are healthy, blocked, atrophic, etc., along with the time, date, and patient's name. This allows the clinician to perform the routine without the need to take manual notes and / or without the need for an assistant to be present. In some embodiments, the eye treatment device 200 may further include a communication device configured to interface with an external PC, tablet, or smartphone to download data, voice recordings, camera images, or video clips.

[0223] FIG. 15A to FIG. 15D Another embodiment of an eye treatment device 200 positioned relative to eyeball 20 to treat MGD, blepharitis, and other medical conditions of eyelid 14 is shown. Figure 3A In an embodiment, eye treatment device 200 is configured to heat the inner and / or outer surface of the eyelid while compressing the eyelid. When heat from eye treatment device 200 is transferred to eye system 10, particularly treatment tissue (such as meibomian glands 18), the heat can soften meibum and thereby allow meibum to be more easily drained during massage or eye exercises. Eye treatment device 200 may include FIG. 2A to FIG. 2H and Figure 3A The configuration of modules and additional components for operating the eye treatment device 200 are depicted.

[0224] The eye treatment device 200 may include a housing 202 having a proximal portion 201 and a distal portion 203 coupled to a removable or consumable portion 260. The housing 202 may include a power module 110, a controller 212, an energy converter module 120, and an energy transfer surface 140. The energy converter module 120 of some embodiments may include an LED device formed by one or more of: an LED emitter 207, a thermal management structure 220, and an energy converter module driver 209. The energy transfer surface 140 and the LED emitter 207 are positioned near the distal portion 203 of the housing 202 and are in a slidable relationship with the energy converter module 120 along the movement path 145 using the actuator 182, which allows the energy transfer surface 140 to move simultaneously with the LED emitter 207.

[0225] The housing 202 may further include: a visualization device 160 for enhancing monitoring of the eyelid margin during diagnosis and treatment; a display or dashboard 218 that displays various temperatures of the eyelid (such as inner surface temperature and / or outer surface temperature); a data logger 214; and / or a recorder 213; and a circuit system that enables communication between the device and the consumable circuit system to identify the type of consumable, which is used to ensure proper alignment of the consumable and / or prevent the consumable from being reused.

[0226] The consumable portion 260 may include a scleral shield 300 (as discussed above) that may be positioned between the eyelids 12, 14 and the eyeball 20 to cover sensitive anatomical structures of the eye system 10 (shown in FIG. 1 ). The scleral shield 300 may be coupled to the housing 202 by one or more support arms 262, wherein the wires are positioned on or within the arms, and in some embodiments, the structural portion of the support arms 262 is made of an insulating material that surrounds or otherwise passes conductive portions of the wires or wire array 420.

[0227] Eye treatment device 200 may include power module 110 for powering various components of eye treatment device 200 and may be electrically coupled to some or all of the components. In certain embodiments having controller 212, controller 212 may receive input instructions from a user (e.g., via another module or device, such as a user interface device 270 of a smartphone, e.g., buttons, switches, touch screen, voice commands) to emit light from LED emitter 207.

[0228] The LED emitter 207 is a part of a type of energy converter module 120 configured to emit light of appropriate wavelengths necessary to perform the desired treatment. The treatment may include one or more of: diagnosing the eyelid by illuminating the inner and / or outer surfaces, the eyelid margins, and / or the meibomian glands behind the eyelids 12, 14; heating a target tissue area of ​​the eye system 10 (e.g., the meibomian glands behind the eyelids 12, 14); and antimicrobial treatment to kill bacteria in the eye system 10.

[0229] 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 transillumination element back to the clinician.

[0230] Many embodiments disclosed herein feature a clinician viewing the energy of the eyelid margin during application of heat and compression. By viewing the eyelid margin, the clinician can see what contents (if any) are discharged from the meibomian gland duct, and thereby adjust the amount of heating and compression applied to the treated eyelid to best unclog the blocked meibomian gland. For example, the clinician can observe at the beginning of treatment that some meibomian glands in the treated eyelid portion have transparent oily discharge, which indicates that the meibomian glands are normal. In contrast, some meibomian glands may secrete turbid oily discharge, or a small amount of thick toothpaste-like lipids, both of which indicate meibomian gland dysfunction. As the clinician applies heat and compression to the treated eyelid portion, further observation of the dysfunctional glands can show that the turbid or thick secretions become transparent, and the amount of discharge may suddenly increase, indicating that one or more meibomian glands have been unclogged. At this point, the clinician can reduce the heat and compression applied to the area because the treatment has successfully unclogged the blocked meibomian glands. Without this continuous visual feedback, clinicians would be limited to applying standard treatment options, which may be under-aggressive or over-aggressive for the specific blocked meibomian gland(s) in a given patient.

[0231] By reference, at least Figure 2D , Figure 2E , Figure 2F , Figure 2G , Figure 2H , Figure 3A , Figure 3B , Fig.15A , Fig. 15B ,and Fig.15D Each shows an example of an embodiment in which the lid margin is exposed for the clinician to visually monitor during treatment.The clinician will be positioned in front of the eye being treated.

[0232] See now Fig.16A, showing a side cross-sectional view of an energy transmission surface 140, an eyelid 14 with a lid margin 14a, a scleral shield 300, and a visualization device 160 with an optical path 175. This embodiment is similar to Figure 2E The embodiment shown is the same except that the image converter 155 is missing. Fig.16A In an embodiment of the present invention, the visualization device can be focused directly on the eyelid margin 14a and more specifically on the meibomian gland duct 19.

[0233] Fig. 16B yes Fig.16A , showing an example where the eyelid 14 is compressed between the energy transmission surface 140 and the scleral shield 300 while the clinician can view the eyelid margin 14a from the front. Figure 2F Same, but without image converter 155.

[0234] Fig. 16C is similar to Fig.16A In the embodiment shown, a support arm 262 is added. The support arm 262 is connected to the Figure 3A , Figure 3B , Figure 7H , Figure 7G ,and Fig. 15B Same as shown.

[0235] Fig.16D yes Fig. 16C The illustrated embodiment is a perspective front view showing a pair of support arms 262 coupled to the scleral occluder 300. By way of example but not limitation, the eyelid margin 14a is exposed and adjacent to the bottom edge of the support arms 262. Fig.16E and Fig.16D The same, but with an aperture 440 highlighted with a thick dashed rectangle for viewing the lid margin 14a. Fig.16F yes Fig.16D and Fig.16E , showing the energy delivery surface 140 compressing the eyelid against the scleral shield 300 with the lid margin 14 exposed for visual monitoring. Figure 16G and Fig.16F The same but with an aperture 440 highlighted with a thick dashed rectangle for viewing the eyelid margin 14a. In an embodiment, the distance between the arms is between 0.2 inches and 1.2 inches. In an embodiment, the distance between a line defined by the attachment points between the two arms and the back plate and a line defined by the attachment points between the two arms and the compression element is at least 0.04 inches.

[0236] Fig.16H yes Fig. 16CA more detailed side cross-sectional view of an embodiment of the invention further defines the boundaries of the orifice 440 in certain preferred embodiments. In this figure, line 1 indicates the lower (horizontal) boundary of the orifice, while line 2 defines the upper (vertical) boundary. Angle 1 is the angle between line 1 and line 2, and is theoretically about 90 degrees, but different anatomical structures of the zygomatic bone and brow structure may cause these boundaries to be different. Fig.16I yes Fig.16H 440 is shown as line 4, and the preferred upper boundary of the orifice 440 is shown as line 6. Angle 2 is the angle between horizontal lines 3 and 4 and is preferably between about 5 degrees and about 20 degrees, while angle 4 is between lines 3 and 6 and is preferably between about 60 degrees and 80 degrees. Angle 3 is the angle between lines 3 and 5 and is the preferred angle for viewing the eyelid margin 14a through the orifice 440, and is preferably between about 25 degrees and 50 degrees.

[0237] Fig.16J Describes something like Fig.16H In the embodiment, except that the energy transmission surface 140 is Fig.16H In this embodiment, the orifice 440 is larger, but the outer boundary defined by lines 7 and 8 is the same as that defined by lines 7 and 8. Fig.16H The outer boundaries defined by lines 1 and 2 in are parallel, and therefore the angle 5 therebetween is also about 90 degrees.

[0238] Figure 16K Similar to the embodiment shown in Figure 16J, except that the scleral shield 300 extends behind both the upper eyelid and the lower eyelid, and a portion of the energy transfer surface 140 is adjacent to the upper eyelid 12 and the lower eyelid 14. In this embodiment, both the upper eyelid and the lower eyelid are heated and compressed, rather than just the lower eyelid. As shown, the support arm 262 is linked to the scleral shield 300, and the energy transfer surface 140 is configured to allow both the upper and lower eyelid margins to be viewed through the orifice 440. Lines 9 and 10 depict the approximate upper and lower limits of the orifice 440, thereby defining an angle 6, which is preferably between about 10 degrees and 150 degrees and more preferably between about 20 degrees and 120 degrees. It should be understood that many modifications to the embodiments disclosed herein are possible, wherein the optical path and thereby the angle associated with the orifice may be changed as follows. For example, an image converter may be employed, such as Figure 2E As shown, other means of reflecting, directing or translating the image of the eyelid margin to the clinician through the orifice may also be used. Alternatively, the orifice may be a light-transmitting window through the structural element. For example, in Figure 16KIn the embodiment of the present invention, the energy transmission surface 140 can completely cover both the upper and lower eyelid portions being treated, and instead of having an opening near the lid margin, at least one section of the energy transmission surface 140 can be transparent enough for the clinician to view the lid margin. In addition, an image sensor, fiber optic bundle, or light pipe can be mounted adjacent to or directed toward the lid margin, and an image of the lid margin can be electronically or optically transmitted to a point outside the energy transmission surface 140. All of these alternative embodiments or other embodiments known to those skilled in the art are included within the scope of the present disclosure.

[0239] Figure 16L Shows Figure 16K . As shown, the dual support arms 262 are linked to the scleral shield 300, and the dual energy transmission surface 140 is seen adjacent to the upper eyelid 12 and the lower eyelid 14. As shown, the upper eyelid margin 12a and the lower eyelid margin 14a, respectively, are visible, and the meibomian gland duct 19 is also visible. Figure 16M and Figure 16L Likewise, wherein the orifice 440 is generally defined by the thick dashed rectangle shown.

[0240] Fig.16N Similar to Figure 16L , but with a single support arm 262. Fig.16O and Fig.16N , but highlights two apertures 440 defined by the gap between the upper and lower energy transfer surfaces 140 and on the left and right sides of the central support arm 262. Other combinations of single or multiple support arms or other structures with single or multiple apertures can also be envisioned by those skilled in the art.

[0241] It should be understood that FIG. 16A to FIG. 16O A unique configuration of energy transmission surface 140, scleral shield 300, and support arm 262 is shown that defines an orifice 440 that allows viewing of one or both eyelid margins during application of heat and compression to the eyelid portion being treated. Many other configurations are possible, and only a few exemplary embodiments are described herein to demonstrate the innovative concepts.

[0242] See now Fig.17A , showing components similar to Figure 3A The energy converter module 120 is positioned adjacent to the proximal end of the energy waveguide module 130. The distal end of the energy waveguide module 130 is adjacent to the energy transfer surface 140, which is formed by the face glass 284 ( Fig. 17C The disposable covering member is formed by the disposable covering member parts 147a and 147b. The part 147b abuts against the eyelid 14. Fig. 17B1 is a front view of an energy converter module 120, which is composed of two infrared LEDs 120a and four lime-emitting LEDs 120b, all of which are mounted on a substrate. Fig. 17C yes FIG. 17A to FIG. 17B 1 is an exploded view of the same components described, including a callout 130a for the inner surface of the energy waveguide module 130. In some embodiments, the energy waveguide module 130 can be in a fixed relationship with the energy converter module 120, while in other embodiments, the energy waveguide module 130 can slide relative to the energy converter module 120, and in other embodiments, the energy converter module 120 can slide relative to 130. In a preferred embodiment, the energy converter module 120 is fixed and the energy waveguide module 130 reciprocates around the energy converter module 120. In such a preferred embodiment, when the energy waveguide module 130 is fully advanced, it pushes the energy transfer surface 140 onto the eyelid 14 (or 12, when treating the upper eyelid).

[0243] To maximize the efficiency of transferring light energy from the energy converter module 120 to the energy transfer surface 140, the inner surface of the energy waveguide module 130 may be coated or lined with a material that is highly reflective of the wavelengths emitted by the energy converter module 120. For example, the inner surface of the energy waveguide module 130 may be coated with a protected silver material, or may be lined with a film such as WRF-150 from Fusion Optix or ESR film from 3M, both of which are designed to provide >97% reflection of wavelengths between 500nm and 900nm.

[0244] In some embodiments, the disposable covering element portion 147a can be made of a plastic or glass material that transmits light energy in the range of 500-880nm. Acrylic is an example of an acceptable material for the disposable covering element portion 147a. The disposable covering element portion 147b is preferably a low durometer material, such as silicone, to provide a soft surface that presses against the eyelid surface. Since most silicones are not completely transparent to infrared energy, it is preferred to keep the thickness of the disposable covering element 147b within the range of 0.02-0.06 inches to minimize energy loss.

[0245] Fig.17DThe distribution of infrared energy transmitted through the eyelid 14 is shown when the module (with its distal end approximately 0.5 inches from the highest point on the infrared LED lens) is fully advanced. Referring to the graph shown on the upper left side, the darker areas are the areas of highest irradiance (watts per square millimeter) and the lighter areas are the areas of lowest irradiance. As shown, the highest irradiance occurs near the middle and the irradiance drops sharply toward the edges. An asymmetric distribution on the X-axis is not ideal because it is desired to heat the eyelid tissue evenly from one edge to the other. Some asymmetry is desirable in the Y-axis direction because most blockages that occur in the meibomian glands are near the orifices or ducts. In the case of treating the lower eyelid and the top edge of the energy transfer surface 140 is aligned with the top edge of the lower eyelid, it is preferred to bias the irradiance curve (and therefore the tissue heating curve) toward the top edge while also warming the entire eyelid.

[0246] In order to improve the irradiance distribution of infrared light, a partial reflective coating 196 may be applied to the surface of a portion of the disposable cover element portion 147a, such as Fig.17E In one embodiment, this coating is an apodization coating that transmits about 33% of the energy in the 820-880 nm range and reflects about 67%. Fig.17F A detailed view of the coating pattern is shown, showing two regions 196a and 196b. Figure 17G The resulting irradiance distribution across the eyelid when utilizing an apodization coating is shown. As shown, the highest irradiance zone is wider and biased toward the top edge, and the irradiance drops off much less along the top edge toward the left and right ends. In this way, the tissue along the upper half of the eyelid will be preferentially heated (in the case of treating the lower eyelid), and the eyelid will be heated more evenly from left to right.

[0247] If the apodization coating 196 also reflects wavelengths within the limelight region (500-600 nm), very little limelight reaches the desired portion of the eyelid and, therefore, less eyelid tissue is heated by chromophore absorption of the limelight energy. To address this issue, in one embodiment, it is preferred that coating region 196a is only partially reflective for infrared (67% reflection, 33% transmission for 820-880 nm; >90% transmission for 500-600 nm limelight) and coating region 196b is partially reflective for both infrared (820-880 nm) and limelight (500-600 nm) (67% reflection, 33% transmission).

[0248] Fig.17HThe limelight irradiance distribution diagram on the eyelid surface is shown for an embodiment with an apodization coating as described above (zone 196a transmits limelight and partially reflects infrared light, while zone 196b partially reflects both). It can be seen that the irradiance pattern is preferably biased toward the upper half of the eyelid and is well distributed from right to left without a significant drop in irradiance.

[0249] It should be appreciated that the examples of coating types or deposition patterns disclosed herein are simple demonstration examples and that alternative configurations may achieve a more uniform distribution of irradiance in a desired spectrum. For example, another method for shaping the heating pattern of the eyelid is to modify the energy absorbing surface 302 of the scleral shield 300 (e.g., Figure 3B For example, if the irradiation pattern is as shown Fig.17D As shown, in order to uniformly heat the scleral occluder, the right and left portions of the surface of the scleral occluder 300 may be more densely coated with energy absorbing material than the center portion of the scleral occluder 300. In addition, in order to bias the heating toward the upper portion of the eyelid, the upper portion of the surface of the scleral occluder may be more densely coated with energy absorbing material. The combination of coatings on elements within the energy transmission path and changes to the energy reflective and absorbing properties of the surface of the scleral occluder are all within the scope of the present disclosure.

[0250] Fig.18A and Fig.18B Another embodiment of an eye treatment device 200 is shown. In some embodiments, the eye treatment device 200 can be configured for use by an eye care professional (ECP). For example, the eye treatment device 200 can allow the ECP to treat the eyelids 12, 14 ( FIG. 18A to FIG. 18BThe system may include a handheld instrument 1800 configured to couple with a sterile disposable component 260 positioned behind the eyelids 12, 14. For example, the sterile disposable component 260 may be disposable, removable, or consumable. In some embodiments, the sterile disposable component 260 may be releasably attached to the handheld instrument 1800, and the handheld instrument 1800 may include a disposable release button 1805. In some embodiments, the handheld instrument 1800 also includes a power button 1807. In some embodiments, the eye treatment device 200 may allow the ECP to view the eyelid margin through a visualization device or visualization device 160 (such as an integrated camera). The eye treatment device 200 may then warm the eyelid tissue to a target temperature range to melt the meibum blocking the hole. In an embodiment, the target temperature range is about 40°C to about 42°C. The eye treatment device 200 may further apply compression to the eyelids 12, 14 to allow the melted meibum to be discharged through the hole. In some embodiments, the amount of heat and pressure applied is always directly controlled by the ECP, and the ECP can monitor the response of the gland and the patient's comfort during treatment.

[0251] like FIG. 18A to FIG. 18BAs shown, the eye treatment device 200 may include an electronic handheld instrument 1800. The handheld instrument 1800 may be used with a sterile disposable component 260, for example, to apply heat and pressure to the eyelids 12, 14. The approximate dimensions of the eye treatment device 200 may be 8" (L) x 1 1 / 2" (W) x 2 1 / 4" (H). The eye treatment device 200 may have other dimensions without departing from the scope of the present disclosure. In some embodiments, the sterile disposable component 260 may be secured to the handheld instrument 1800 by at least two latches 1801. The at least two latches 1801 may grasp at least one attachment tab 2203 (not shown). The sterile disposable component 260 may be released from the handheld instrument 1800 by pressing the disposable release button 1805. The eye treatment device 200 may include electronic circuits that read the temperature sensors 310 in the inner eyelid pad 300 and the outer eyelid pad 147. These electronic circuits may be used to measure a temperature representative of the inner eyelid temperature and The temperature of the outer eyelid temperature. The warming can be achieved by using light energy emitted from an LED in the handheld instrument 1800. A mechanism in the handheld instrument 1800 can allow the operator to control the movement of the outer eyelid pad 147 by using finger pressure applied to the compression control button 1822 to apply pressure to the eyelid. In some embodiments, the eye treatment device 200 can also include a graphical screen or display 244, which is configured to display information such as used to operate the handheld instrument 1800 during treatment. In some embodiments, the eye treatment device 200 can include a visualization device or visualization device 160, which is configured to allow the operator to view the lid margin during treatment.

[0252] The eyelid temperature can be measured using sensors 310 in the sterilized disposable component 260 (including two sensors in the eyelid outer pad 147 and two sensors in the eyelid inner pad 300). For example, these sensors can be mounted on a flexible printed circuit board (PCB) that can also have an array of contact pads. When the sterilized disposable component 260 is attached to the handheld instrument 1800, a spring-loaded pin (not shown) mounted below the shield 2100 can form an electrical connection with the eyelid outer pad 140 and the eyelid inner pad 300 in the sterilized disposable component 260. In some embodiments, the electronic circuit system in the handheld instrument 1800 can read the sensor and can quickly determine the temperature, for example, more than 20 times per second. The accuracy of the temperature measurement system can be ±1°C. In some embodiments, the electronic circuit system performs a self-test check to ensure that the sensor is operating properly. For example, if the electronic circuit system detects a fault, an error code can be displayed and the heat source can be disabled.

[0253] In some embodiments of the ocular treatment device 200, the pressure applied to the eyelid can be controlled by the ECP, such as by the ECP using his thumb or finger to press down the compression control button 1822. Such pressing down of the compression control button 1822 can 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 shield 2100. The shield 2100 can be a component that is removable and surrounds the warming LED and directs light to the eyelid. In some embodiments, the compression control button 1822 is connected to the shield 2100, thereby enabling the clinician to push the outer eyelid pad 147 using thumb or finger force. For example, the applied force can be measured by a sensor installed in the mechanism of the compression control button 1822 and can be displayed on the display screen 244 in a relative number from 1 to 9. The displayed value can serve as a relative reference 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.

[0254] In some embodiments, eyelid tissue can be heated by light energy generated by an LED in the handheld instrument 1800 and transmitted through the transparent eyelid outer pad 300. The LED can be positioned behind a transparent window on the open end of the shield 2100. For example, two wavelengths of light can be used: gray-green light and near infrared light. Chromophores in the eyelid can absorb the light energy and thereby heat the surrounding tissue.

[0255] In some embodiments, the top surface of the compression control button 1822 has a heater control switch 1802 that can be slid forward by the operator's thumb or index finger, thereby turning on the warm-up LED. The heater control switch 1802 can have a spring return feature so that when it is released or when the operator's thumb or index finger is released, the heater control switch 1802 returns to its normal "off" position.

[0256] In some embodiments, the eye treatment device 200 can be designed to protect the eye from accidental exposure to light. For example, the inner eyelid pad 300 and the eye shield can block the light 211 from shining directly into the eye during treatment. In some embodiments, if an effective sterilization 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, the handheld instrument 1800 may not be able to heat up the LED.

[0257] Fig.19An example of a front plate or force pad used as an eyelid pad 147 is shown, which can be interposed between the eye treatment device 200 and the patient's eyelids 12, 14 to provide a barrier during treatment. In some embodiments, the eyelid pad 147 can be a transparent eyelid pad 147, that is, it can be used as a window through which energy can pass and be delivered to the eyelids 12, 14. For example, the transparent eyelid pad 147 can be made of any suitable material, such as glass, Pyrex glass, quartz, mica, or polymers (such as polycarbonate or other optically transparent materials), or a combination thereof, to obtain the desired structural and optical properties. In an embodiment, the eyelid pad 147 can be configured to directly contact the patient's eyelids 12, 14. In other embodiments, the eyelid pad 147 can be configured to be a small distance away from the eyelids 12, 14 during treatment, such as 0.5mm to 12mm away from the eyelids. Preferably, the outer surface of the eyelid pad 147 is configured to be smooth and easy to clean. For example, the transparent eyelid outer pad 147 can be in a slidable relationship relative to the energy converter module 120 or the scleral shield 300 or the housing 202 along the travel path 145 to ensure that the transparent eyelid outer pad 147 can press against the eyelids 12, 14. The pressure of the transparent eyelid outer pad 147 on the eyelids 12, 14 can be used to minimize photon energy leakage during treatment and / or imaging, and if necessary, apply compressive force to the eyelids 12, 14 during assessment and / or drainage of the meibomian glands.

[0258] Fig.19 An embodiment of an outer eyelid pad 147 is shown that includes a set of temperature sensors 310 positioned toward the outer eyelid. In some embodiments, the temperature sensors 310 can be discrete components (such as thermocouples made of very thin wires, microthermistors, etc.) embedded or positioned in the outer eyelid pad 147. In addition and / or alternatively, the set of temperature sensors 310 can be thermocouples formed by depositing one or more thin layers of suitable metals on the middle layer of the outer eyelid pad 147. In some embodiments, the preferred type of material for the outer eyelid pad 147 is a soft, flexible, biocompatible material, such as silicone, polyurethane, and various hydrogels similar to those used in contact lenses.

[0259] In an embodiment, the outer eyelid pad 147 may also include a plurality of bumps on the eyelid-facing surface to create space for the set of temperature sensors 310 .

[0260] The set of temperature sensors 310 can be configured to sense the position of the ocular treatment device 200 relative to the patient's eyelids 12, 14. The set of temperature sensors 310 can be temperature sensors that measure room temperature before the eyelids are placed in the device. When the set of temperature sensors 310 are positioned near the eyelid skin, the set of temperature sensors 310 registers a value closer to body temperature and thus confirms proper positioning. If the set of temperature sensors 310 do not match, such as one sensor showing room temperature and the other showing eyelid temperature, it can indicate that the eyelid is not properly positioned in the ocular treatment device 200 for treatment.

[0261] Fig.19 An embodiment of a front plate or eyelid outer pad 147 with a sensor 310 is shown that is designed to measure eyelid temperature. When infrared light waves hit the skin, a portion of the light is reflected back to the sensor 310 and may heat the sensor 310. This may result in an incorrect reading of the eyelid temperature. In some embodiments, to prevent unwanted photon heating of the sensor 310, the sensor 310 may be covered with a reflective paint and / or a white paint.

[0262] See again Fig.19 , when infrared light waves hit the skin, they are absorbed and the energy from the light is converted into heat, thereby warming the skin. In general, darker skin colors absorb more infrared light than lighter skin colors, so this means that darker skin gets hotter faster as it converts more light into heat.

[0263] Using this knowledge, the eye treatment device 200 may be able to 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 stationary back plate to measure the inner eyelid surface temperature and the outer eyelid surface temperature during heating. If the outer eyelid surface heats up quickly, it may indicate a darker skin color, whereas if the outer skin surface heats up slowly, it may indicate a lighter skin color.

[0264] In some embodiments, to compensate for this difference in warming rates for different levels of skin pigmentation, the eye treatment device 200 can adjust the light so that the inner skin and outer skin warm up at the same rate. For example, the frequency of the light can be adjusted to increase the warming rate for a slow warming surface so that the inner eyelid and outer eyelid warm up at the same rate. If the inner eyelid skin needs to warm up more, the eye treatment device 200 can turn up the green light and turn down the infrared light. In other embodiments, the light used can be of multiple wavelengths to adjust between the plates and maintain the same warming.

[0265] Some embodiments of the eye treatment device 200 may include a first set of sensors that may be positioned on a surface of the transparent outer eyelid pad 147 and facing the outer eyelid to monitor the temperature of the outer eyelid surface; and a second set of sensors that may be coupled to the scleral shield 300 on a surface facing the inner eyelid to monitor the temperature of the eyelid surface. Such placement may allow a thermocouple or thermistor to detect the temperature of the inner and / or outer surfaces of the eyelid. For example, the first and second sets of sensors may be connected to the controller 212, and the sensors may be configured to detect the temperature of the outer eyelid surface and / or the inner eyelid surface and communicate the temperature information to the controller 212. Monitoring the temperature of such surfaces may help ensure that the patient does not experience significant discomfort or injury as a result of using the eye treatment device 200.

[0266] In some embodiments, both the first and second group of sensors can be safety sensors. The first and second group of sensors can preferably be non-contact sensors, such as thermoelectric sensors (e.g., IRA-E700ST0 from Murata, Japan), or thermopiles (e.g., ST25T0-18 from Dexter Research, Michigan), or conventional temperature monitoring devices (e.g., thermocouples, thermistors, fiber optic thermal sensors, or digital temperature sensors (e.g., Dallas Semiconductor DS-18B20). In some embodiments, the first and second group of sensors can be discrete components embedded in the eyelid outer pad 147 (e.g., in a recess) and / or the scleral shield 300 (e.g., thermocouples made of very thin wires, or micro-thermistors, etc.). In some embodiments, the first and second group of sensors can be formed by depositing appropriate metal films on the surface layer and / or intermediate layer of the eyelid outer pad 147 and / or the scleral shield 300.

[0267] In some embodiments, the eye treatment device 200 may include a current sensing circuit for monitoring LED functionality. The current sensing circuit may be a circuit configured to sense current passing through the current sensing circuit to the LED. For example, the current sensing circuit may be configured to detect a fault condition, such as a short or open circuit in the current path, which may be caused by a connection problem and / or a problem with the LED. In such a current sensing circuit, it is important to not only detect the condition, but also to ensure safe operation of the detection circuit system itself. If a fault is detected, the system may disable the faulty circuit and / or disable the eye treatment device 200. In such a case, an error code may be displayed on the screen to alert the user or clinician to the fault condition.

[0268] In some embodiments, after the eyelids 12, 14 reach a target temperature range, such as a treatment temperature, the user or clinician may wish to know how long the eyelids remain within the target temperature range. For example, the target temperature range may be between the minimum temperature required for treating an eye condition and the maximum temperature that may cause discomfort to the eyes or eyelids or cause thermal damage if exceeded. In some such embodiments, the target temperature range is between about 40 to about 80 degrees Celsius. In some embodiments, the target temperature range is between 50 degrees Celsius and 80 degrees Celsius. In some embodiments, the target temperature range is between 60 degrees Celsius and 80 degrees Celsius. In some embodiments, the target temperature range is between 70 degrees Celsius and 80 degrees Celsius. In some embodiments, the target temperature range is between 40 degrees Celsius and 70 degrees Celsius. In some embodiments, the target temperature range is between 40 degrees Celsius and 60 degrees Celsius. In some embodiments, the target temperature range is between 40 degrees Celsius and 50 degrees Celsius. In some embodiments, the target temperature range is between 40 degrees Celsius and 45 degrees Celsius.

[0269] like Fig. 20 As shown, the eye treatment device 200 may include a melting time indicator configured to count the time that the eyelids 12, 14 are within the target temperature range. The melting time may be displayed on the display 244 of the handheld device 1800. For example, the timer may start a counter after the eyelid temperature reaches a minimum temperature, and may continue to count until the eyelid temperature drops below the minimum temperature. In some embodiments, the timer may use the actual measured temperature at the measurement time, while in other embodiments, the timer may use a preset time period.

[0270] Fig. 20 An embodiment of dashboard 218 is shown with display screen 244 configured to display the status of ocular treatment device 200. For example, dashboard 218 may include a temperature measurement device or device configured to measure various temperatures of the eyelid, such as inner surface temperature and / or outer surface temperature; a data logger 214; a voice recorder 213; a battery configured to power components of the dashboard; a battery charging device; a controller; a printed circuit board; and / or communication circuitry between scleral shield 300 and energy converter 205.

[0271] In some embodiments, eye treatment device 200 may further include display screen 244 configured for inner eyelid temperature and outer eyelid temperature. For example, the temperature display feature may display an absolute temperature, or may display a relative temperature with a maximum value. For example, the temperature may be displayed in a bar graph format, or displayed with one or more lights, etc.

[0272] In some embodiments, during use of ocular treatment device 200, the temperature of the inner eyelid surface and / or the outer eyelid surface may be measured and displayed to the clinician on display screen 244. For example, the clinician may apply heating energy to the eyelid, and when the eyelid temperature reaches a therapeutic temperature, the clinician may apply compression while visually monitoring the lid margin to optimize meibum drainage from blocked meibomian glands.

[0273] Fig.21A and Fig. 21B Another embodiment of an eye treatment device 200 is shown. Figure 3A yes FIG. 21A to FIG. 21B Schematic side plan view of an embodiment of an eye treatment device 200 that is operable and transmits light 211 to the eyeball 20 and treatment tissue. In some embodiments, a removable light pipe or shield 2100 with an internal reflective surface can be used to reflect or direct light 211 toward the energy transmission surface 140, thereby improving the heating efficiency of the target tissue. Fig.21A The shield 2100 is shown in a retracted position, while Fig. 21B The shield 2100 is shown in an advanced position. The shield 2100 can be used, for example, when the light 211 emitted from the energy converter module 120 includes a portion of the light 211 that is initially radiated at an angle such that, without correction, the light 211 does not reach the energy delivery surface 140 but reaches the treatment tissue. A movable light pipe or shield 2100 can be used to correct the light 211 and focus it toward the treatment tissue.

[0274] In some embodiments, the movable reflector, light pipe or shield 2100 can be a sliding assembly that surrounds the heat source LED and directs light 211 to the eyelid. For example, the user or clinician can control the movement of the shield 2100 by pressing the compression control button 1822 connected to the shield 2100. In some embodiments, when the sterilized disposable component 260 is attached to the handheld instrument 1800, the eyelid outer pad 147 can be automatically attached to the front of the shield 2100. When the clinician presses the compression control button 1822, the shield 2100 and the eyelid outer pad 147 can be advanced toward the eyelid. In some embodiments, the eyelid outer pad 147 is positioned at the eyelid surface to heat the eyelid without compressing it. In other embodiments, the eyelid is compressed between the eyelid outer pad 147 and the static rear plate. For example, when the clinician presses the compression control button 1822 with his finger or thumb, the shield 2100 and the eyelid outer pad 147 are advanced toward the static rear plate. Thus, the amount of heat and pressure applied can be directly controlled by the clinician, who can monitor the response of the gland and the comfort of the patient.

[0275] In some embodiments, the inner wall surface of the shield 2100 can be smooth and / or polished to avoid or minimize scattering of the light 211 when it is reflected from the wall. For example, the wall can have a mirror-like surface so that even when the light 211 hits the side wall, the reflection of the light 211 remains within the shield 2100. In embodiments, the mirror surface of the wall can be obtained by depositing one or more reflective layers using any known means, for example, silvering, aluminizing or laminating a mirror film, or other types of mirror finishing, to further enhance the ability of the shield 2100 to conduct the light 211.

[0276] Fig. 22 and Fig.23 An embodiment of a front pad of an eye treatment device is shown. For example, an outer eyelid pad 147 can be interposed between a light source of an eye treatment device 200 and an outer eyelid of a patient. The outer eyelid pad 147 can be configured to engage the shield 2100 when the shield 2100 is extended for treatment. Since the shield 2100 can heat up during treatment, the outer eyelid pad 147 can include a peripheral frame to engage the wall of the shield 2100 to prevent the outer eyelid pad 147 from heating up.

[0277] In some embodiments, the eyelid outer pad 147 may not be used to protect the eyes from thermal energy, but may be used to measure temperature. For example, the eyelid outer pad 147 may be made of a material that is substantially transparent to the energy emitted from the energy converter. By way of specific example, if the energy converter is a light source, the eyelid outer pad 147 may be made of a transparent material that does not block the passage of the wavelength(s) of light emitted by the energy converter.

[0278] Fig. 22 An embodiment of a sterilizable disposable component 260 is shown. In an embodiment, the sterilizable disposable component 260 includes the following exemplary components: inner eyelid pad 300, outer eyelid pad 147, eye shield 264, silicone cover 2201, attachment tab 2203, guide 2204, and support arm 2205.

[0279] The eyelid inner pad 300 can be made of plastic that is configured to be heated by a light-based heat source in the handheld instrument 1800. In an embodiment, the plastic component can be surrounded by a soft, biocompatible silicone cover 2201. In an embodiment, two temperature sensors 310 that can measure the inner surface temperature of the eyelid are positioned in the eyelid inner pad 300. The eyelid inner pad 300 is also referred to as a back plate.

[0280] The outer eyelid pad 147 can be configured as a transparent biocompatible silicone pad mounted on a plastic frame. In an embodiment, the minimum thickness of the plastic frame at the location of the temperature sensor 310 can be 0.010". In some embodiments, the outer eyelid pad 147 is in contact with the patient during treatment. When the sterilized disposable component 260 is attached to the handheld instrument 1800, the frame can be attached to the shield 2100 of the handheld instrument 1800. Light from a heat source in the handheld instrument 1800 can pass through the outer eyelid pad 147 to heat the eyelid tissue. In some embodiments, two temperature sensors 310 that can measure the inner surface temperature of the eyelid are positioned in the outer eyelid pad 147.

[0281] The eye shield 264 can block light emitted from the handheld instrument 1800 and thereby shield portions of the eye that are not intended to be heated. In an embodiment, the eyelid inner pad 300 and a portion of the eye shield 264 can be covered with a soft, biocompatible silicone component or silicone cover 2201. For example, the minimum thickness of the silicone cover 2210 at the location of the temperature sensor 310 can be 0.010". In some embodiments, the silicone cover 2201 is in contact with the patient during treatment.

[0282] The sterile disposable component 260 can be secured to the handheld instrument 1800 via the attachment tabs 2203. For example, when the sterile disposable component 260 is attached to the handheld device 1800, a spring-loaded latch can engage with an opening in each attachment tab 2203, thereby securing the sterile disposable component 260 to the handheld instrument 1800. Guides 2204 can assist in aligning the sterile disposable component 260 with the handheld instrument 1800. Support arms 2205 can connect the eyelid liner 300 to the body of the sterile disposable component 260. These support arms 2205 serve as guides for inserting the eyelid liner 300 at the proper depth behind the eyelid.

[0283] Fig.23 is an exploded view of the sterilizable disposable component 260 showing an embodiment of the temperature sensor 310 on the outer eyelid pad 147. Fig.23 Any of the pads shown may be formed from multiple pieces, or may be one unitary piece. In an embodiment, the temperature sensor 310 may be designed to measure outer eyelid temperature. During use, light 211 may hit the back of such a temperature sensor 310. If this occurs, the temperature sensor 310 may read the light temperature, rather than the eyelid temperature. To prevent this, the temperature sensor 310 may be covered with a material that does not heat up. For example, the back of the temperature sensor 310 may be covered with a reflective coating to reflect light 211 away from the temperature sensor 310 and not heat the back of the temperature sensor 310.

[0284] Fig.23 An embodiment of a sterile disposable component 260 that is designed to be disposable and should not be reused is shown. In some embodiments, to track the number of uses, the sterile disposable component 260 may include its own memory that contains customized treatment parameters. For example, the customized treatment parameters may include, for example, the number of available uses of the disposable sterile disposable component 260, and the information is transmitted to the eye treatment device 200. Once the eye treatment device 200 is used for treatment, the customized treatment parameters will not all allow it to be used again. In some embodiments, once the sterile disposable component 260 is attached, the usage information may also be displayed on the display 244, so the user knows that the sterile disposable component 260 can be used once.

[0285] In some embodiments, sterile disposable component 260 may be designed to be used multiple times. For example, an onboard memory may track the number of uses, and once the maximum number of uses is reached, eye treatment device 200 will not allow treatment with sterile disposable component 260. When sterile disposable component 260 is attached, this information may be displayed on display 244, showing the remaining available number of uses. Once the maximum number of uses allowed for treatment with eye treatment device 200 is reached, the customized treatment parameters will not allow it to be used again.

[0286] Fig.23 and Fig.24 An embodiment of a stationary back plate or stationary eyelid lining 300 is shown. In an embodiment, the stationary eyelid lining 300 can be configured to be positioned between the eyelids 12, 14 and the eyeball 20 to cover sensitive anatomical structures of the ocular system 10 and prevent the light 211 from contacting the eyeball 20. For example, the stationary eyelid lining 300 can include a reflective surface configured to receive the light 211 and reflect the light 211 toward the inner surface of the eyelid to warm it.

[0287] In some embodiments, the stationary eyelid inner pad 300 may include a set of temperature sensors 310 positioned toward the inner eyelid. For example, the temperature sensors 310 may be discrete components (such as thermocouples made of very thin wires, microthermistors, etc.) embedded or positioned in the stationary eyelid inner pad 300. In some embodiments, the set of temperature sensors 310 may be thermocouples formed by depositing a thin layer of an appropriate metal on the middle layer of the stationary eyelid inner pad 300.

[0288] In an embodiment, to prevent the stationary inner eyelid pad 300 from warming or heating the set of temperature sensors 310, the energy absorbing or reflective surface of the stationary inner eyelid pad 300 may include a sensor window through which the set of temperature sensors 310 extend and thereby directly contact the inner surface of the eyelid.

[0289] Fig.19 and Fig.24 is a view showing details of an embodiment of a front plate or outer eyelid pad 147 and a rear plate or inner eyelid pad 300. In some embodiments, the set of temperature sensors 310 are redundant sensors that are juxtaposed for redundancy and improved accuracy. Each set of temperature sensors 310 can provide a primary and secondary measurement of eyelid temperature. The secondary measurement of eyelid temperature can be used in conjunction with the primary measurement of eyelid temperature to improve temperature sensing accuracy and reliability.

[0290] In some embodiments, obtaining two or more temperature readings facilitates redundancy.An aspect of the present disclosure includes the step of comparing the primary eyelid temperature reading to the secondary eyelid temperature reading to determine if both sensors in the set of temperature sensors 310 are operational.

[0291] The set of temperature sensors 310 may be subject to mechanical and / or thermal stress, and one of the set of temperature sensors 310 may cease to function. 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 a routine.

[0292] In some embodiments, a set of inner eyelid temperature sensors and outer eyelid temperature sensors 310 can be the temperature sensors 310. For example, each set of temperature sensors 310 can measure the inner eyelid surface temperature or the outer eyelid surface temperature. The two sets of temperature sensors 310 should read the same temperature. If the temperatures provided by one set of temperature sensors 310 do not match, it may mean that the treatment is not properly placed on the eyelid, or there is a problem and the system should be turned off.

[0293] Fig.23 and Fig.24 An embodiment of a sterilized disposable component 260 including an identification (ID) chip is shown. The ID chip can prevent counterfeit disposables by ensuring that a genuine sterilized disposable component 260 is used in treatment. The ID chip can also provide automatic treatment tracking by tracking the use of the sterilized disposable component 260 and compliance with disposable guidelines for maximum use times. Accordingly, the ID chip can help maintain inventory visibility by managing reserve quantities and inventory in real time for direct purchase and consignment.

[0294] In some embodiments, the eye treatment device 200 may use an authentication method and / or protocol to determine whether the sterilized disposable component 260 is counterfeit. For example, the eye treatment device 200 may include the following communication protocol: it is configured to provide the ability to distinguish between an authenticated sterilized disposable component 260 and an unauthenticated replica. The communication protocol can be further configured to allow the eye treatment device 200 to reject the sterilized disposable component when it is determined that the sterilized disposable component 260 is an unauthenticated replica. In some embodiments, the eye treatment device 200 may also include the following mechanism: to limit the use of the sterilized disposable component 260 and / or count its number of uses, and allow the eye treatment device 200 to reject the sterilized disposable component when the sterilized disposable component 260 exceeds the maximum allowed use and / or number of uses.

[0295] In some embodiments, sterile disposable component 260 includes onboard memory containing customized treatment parameters specific to the type of sterile disposable component 260 being used. For example, when sterile disposable component 260 is attached to ocular treatment device 200, ocular treatment device 200 can read the treatment parameters and adjust the treatment to match the customized parameters.

[0296] In some embodiments, different sterile disposable components 260 are used during treatment of the eye. Thus, customized treatment parameters may include light settings for each different sterile disposable component 260. For example, some sterile disposable components 260 may have different back plate designs and therefore may require different treatment settings. In some embodiments, the back plate may include an energy absorbing portion that heats up and then transfers the heat to the inner eyelid. In other embodiments, the back plate may have a reflective surface for reflecting light energy back to the eyelid for heating.

[0297] In some embodiments, the sterilized disposable component 260 can be used to take pictures of the eyelid, and the customized parameters can include a light lockout feature configured to ensure that light does not shine out.

[0298] In some embodiments, the sterile disposable component 260 can be used for both treatment and recording. For example, treatment parameters can include interleaving of video clips and light-based heating so that the video is not washed out.

[0299] Fig.19 , Fig. 22 , Fig.23 ,and Fig.24 18 is an embodiment showing a sterile disposable component 260 that is sterile, one-time use and includes all parts that contact at least the patient's eyelid. The sterile disposable component 260 is removed from the packaging and attached to the handheld instrument 1800 before use.

[0300] Handheld instrument 1800 is a handheld eye treatment device 200 that allows the ECP to view, heat, and compress the portion of the eyelid that is in contact with the sterile disposable component 260. The heating source is the light radiation produced by the gray-green and infrared LEDs in the handheld instrument 1800.

[0301] In some embodiments, an internal rechargeable lithium-ion battery provides power to operate the handheld instrument 1800. For example, the battery can be recharged by placing the handheld instrument 1800 in a separate charging cradle powered by an AC power supply.

[0302] Fig. 22 The main portion of the sterile disposable component 260 is shown. In some embodiments, the approximate dimensions of the sterile disposable component 260 may be 1 1 / 2" (L) x 1" (W) x 1" (H). The sterile disposable component 260 can have different sizes without departing from the scope of the present disclosure. In an embodiment, the sterile disposable component 260 can be a sterile component that is used for a single patient treatment and then discarded. For example, during treatment, the eyelid inner pad 300 can be inserted behind the fornix of the eyelid and can be intended to contact the mucosal lining (i.e., the palpebral conjunctiva). The eyelid outer pad 147 (opposite the eyelid inner pad 300) can contact the skin on the outer surface of the eyelid. Light 211 generated by the handheld instrument 1800 can be transmitted through the transparent eyelid outer pad 147 to warm the eyelid tissue. The eyelid outer pad 147 can be used to apply pressure to the eyelid by moving the eyelid toward the eyelid inner pad 300 through a mechanism in the handheld instrument 1800. The temperature sensor 310 in the eyelid outer pad 147 and the eyelid inner pad 300 can monitor the eyelid temperature during treatment.

[0303] Fig.19 , Fig.23 ,and Fig.24 The illustrated embodiment of the sterilized disposable component 260 may further include a drug eluting front pad and / or back pad that may contact the eyelid and deliver the drug to the outer surface of the eyelid and / or the inner surface of the eyelid. The drug may treat a variety of conditions. For example, the drug eluting pad may include one or more of: a numbing agent, such as to block the eyelid nerves from feeling pain or discomfort during treatment; an antibiotic, such as used to treat blepharitis, to reduce inflammation and relieve symptoms more quickly; and / or a steroid, such as used to treat inflammatory skin conditions, including atopic dermatitis, psoriasis, seborrhea, contact dermatitis, and the like. Some therapeutic drugs may require additional assistance, such as iontophoresis, to penetrate the eyelid skin.

[0304] Iontophoresis is a method based on the transfer of charged molecules using low-intensity electric current to deliver non-invasive transdermal drugs to the eyelid skin. In some embodiments, the eye treatment device 200 can deliver drugs to the eyelid via iontophoresis-mediated drug infusion. For example, a disposable pad can include a drug, and iontophoresis-mediated drug infusion can use a weak electric current to stimulate the drug-carrying ions to pass through the eyelid skin. The current can be provided by the sterilized disposable component 260 and the handheld instrument 1800. In some cases, local anesthesia may be required for eyelid treatment for patients who are concerned about pain. For these cases, iontophoresis-mediated drug infusion can be used to deliver lidocaine to the eyelid.

[0305] In some embodiments, eye treatment device 200 can be configured to treat hordeolum and / or chalazion. Chalazion and chalazion (sty) are localized swellings of the eyelid that occur suddenly. Chalazion is caused by non-infectious obstruction of the meibomian glands, while chalazion is caused by infection. Both conditions initially cause eyelid congestion and edema, swelling, and pain.

[0306] To treat hordeolum, the inner eyelid pad 300 and / or the outer eyelid pad 147 may include features that focus pressure on the stye or papule to squeeze the eyelid and drain the hordeolum. To treat chalazion, the inner eyelid pad 300 and / or the outer eyelid pad 147 may include features that focus pressure on the blocked meibomian gland to flush the gland.

[0307] In some embodiments, the eye treatment device 200 may include an integrated camera as a visualization device 160. For example, the integrated camera or integrated visualization device 160 may allow a user to determine how the treatment is progressing before, during, or after treatment. In some embodiments, the integrated visualization device 160 may include fixed optics, adaptive optics, and / or active optics to view different areas of the eyelid, including the anterior surface, the posterior surface, and the lid margin. For example, the adaptive optics and active optics may be configured to focus and / or zoom onto an image or target area. When viewing the lid margin, the integrated visualization device 160 may view the drainage of the glands. When viewing the posterior portion of the eyelid with a light shining on the anterior portion of the eyelid, the integrated visualization device 160 may view the internal glandular structure of the eyelid.

[0308] In some embodiments, the integrated visualization device 160 can provide a video and / or still image of the eyelid. The integrated visualization device 160 can be further coupled to electronics to record the image and / or transmit it to an external device. In some embodiments, the integrated visualization device 160 can include electronics. In some embodiments, the integrated visualization device 160 can be coupled to a device controller, wherein the controller is capable of storing and / or transmitting still images and / or video.

[0309] The eyelids of mammals are curved, and due to the natural ability of the eye to adapt (refocus) to curvature, this curvature does not seriously affect direct visual observation by looking. However, when using a camera, field curvature can cause defocus errors, which can be significant. One way to correct for field curvature is to place a single thin lens in front of the final focus. By properly choosing the parameters, the thin lens flattens the field while causing very low aberrations. In some embodiments, a field flattener can be used to flatten the curved image. For example, a field flattener can provide more focus across the field.

[0310] In some embodiments, the eye treatment device 200 may have the power to have its own video display. In some embodiments, the video may be recorded to a memory within the device, or the video may be recorded to a portable drive such as a microSD. Once a routine is completed, the portable drive may be removed and replaced with a blank drive for the next routine.

[0311] When the integrated visualization device 160 captures video during treatment, the light 211 used for heating may wash out the captured video or picture.One solution is to interleave video and light-based heating. Fig.25 The pulsing of the light source and visualization device 160 is shown, for example, when the light is disabled and the camera is turned on, and when the light is enabled and the camera is turned off. This can allow video to be taken without interference from the light 211.

[0312] In some embodiments, the eye treatment device 200 may include a dedicated photo disposable, such as to take photos of the eyelid before and after treatment. For example, the photo disposable may be similar to the sterilized disposable component 260, but a spacer may be used in place of the stationary back plate 300 to position the eyelid in the proper position. The dedicated photo disposable does not include the back plate 300 because the light 211 is not enabled and is not directed toward the eye. During use, the photo disposable may initially be used to take photos prior to treatment. The photo disposable may then be replaced with the sterilized disposable component 260. When treatment is completed, the sterilized disposable component 260 may be removed and replaced with the photo disposable.

[0313] In some embodiments, the photo disposable may include a memory with parameters for customizing camera settings. For example, the photo disposable may be configured to control the type of light used depending on the photo setting. For example, one setting may direct the eye treatment device 200 to shine a white light on the eyelid for visualization, while another setting may include using infrared light to take the photo.

[0314] In some embodiments, the photo disposable may include a diffractive surface that changes the path of light. As light changes the angle at which it travels through the surface, refraction occurs. The diffractive surface may narrow the light beam, widen the light beam, or scatter the light beam. In some embodiments, it may be desirable to diffract the light into a narrow beam to focus on a desired treatment area of ​​the eyelid. In some embodiments, it may be desirable to widen the light beam to widen the treatment area on the eyelid. In some cases, it may be desirable to diffract the light to more evenly cover the treatment area.

[0315] In some embodiments, the eye treatment device 200 can be configured to stream video using the integrated visualization device 160. For example, the integrated visualization device 160 and / or the eye treatment device 200 can include a wireless link to send the video to an external device, such as an external monitor for viewing, or stream the video to another external device, such as a computer. In some embodiments, metadata can be added to the live video stream to relay more treatment information on the monitor. For example, the metadata can include sensor readings, such as information about inner eyelid temperature and / or outer eyelid temperature, pressure and / or force applied to the eyelid, light intensity, light frequency, etc. Other data may also be included, such as the date and time, the patient's name or medical record number, the clinician's name, or other information related to the treatment.

[0316] Meibography is a technique that generates information about the morphological properties of the meibomian glands by transilluminating the eyelids 12, 14 and observing their silhouettes. One type of meibography is a non-contact infrared meibography technique that allows non-contact observation of the meibomian gland structure without discomfort to the patient. Meibography is combined with LED infrared light to capture images of the meibomian glands of the upper and lower eyelids. It provides a detailed picture of the meibomian gland structure, including those glands that have increased tortuosity or stopped functioning, resulting in meibomian gland shedding. The non-contact meibography system may include an integrated visualization device 160, an external monitor, and / or a recording device. An infrared light source may be used to obtain images. Such a meibomian gland system may allow easy observation of the meibomian gland structure in both the upper and lower eyelids without discomfort to the patient.

[0317] Transillumination can be used to image the meibomian glands in one of several ways. In one variation, the illuminating light can be directed at an angle to the outer surface of the eyelid, where imaging is also performed from the outer surface of the eyelid. This is referred to as oblique illumination. In a second variation, light can be directed through the eyelid from behind the eyelid, where imaging is performed through the outer surface of the eyelid. In a third variation, the surface is illuminated from the front in a manner so that the light source partially blocks the image being recorded, where the multiple images used are averaged, added, or otherwise combined to produce a complete image. In each case, the meibomian glands are illuminated to visually inspect the glands using light transmitted through the eyelid tissue. The eyelids can then be imaged using still or moving photography (visible light, NIR or IR or other suitable wavelengths of light) in a manner similar to that described above.

[0318] One method of viewing the glands is via transillumination of the eyelid and observation with the integrated visualization device 160. For example, a light can be positioned on one side of the eyelid, and then the silhouette of the meibomian glands on the other side of the eyelid can be observed using the integrated visualization device 160. This method can provide information about the morphology and physical properties of the meibomian glands. Some of the information that can be measured can include the size of the glands and the degree of gland shedding, or the area of ​​loss of the meibomian glands, etc.

[0319] In some embodiments, the eye treatment device 200 can be used to assess the severity of dry eyes by observing the tear film breakup time. The tear film breakup time is a method to determine the stability of the tear film and check for evaporative dry eyes. The tear film breakup time can help assess the stability of the tear film and therefore assess the severity of meibomian gland dysfunction. When testing the tear film breakup time, fluorescein dye is applied to the eye and the eyelids are kept open. A magnifier is used to observe the tear film while the patient avoids blinking until tiny dry spots appear, i.e., the tear film breaks. Then, the tear film breakup time is measured. In some embodiments, the eye treatment device 200 may have a timing feature that is configured to record tear film breakup time measurements. A shorter tear film breakup time indicates a poor tear film, while a longer tear film breakup time indicates that the tear film is more stable. For example, >10 seconds is considered a normal tear film breakup time, 5 to 10 seconds is considered a critical tear film breakup time, and <5 seconds is considered a short tear film breakup time.

[0320] In some embodiments, the eye treatment device 200 can be used for skin pigmentation measurements and can be adjusted to develop treatment parameters based on pigmentation. For example, the integrated visualization device 160 can view and / or record the skin as light reflects off the skin. There are differences in reflection between different skin types. Using this knowledge, the eye treatment device 200 can develop treatment parameters based on skin pigmentation as indicated by the light reflection measurement. In general, darker skin colors absorb more infrared light than lighter skin colors, so the skin gets hotter faster as it converts more light into heat. Therefore, the eye treatment device 200 can be configured to develop treatment parameters by adjusting the light frequency based on the pigment measurement.

[0321] The pigmentation of the skin is related to the amount of melanin in the epidermal keratinocytes. Various amounts of melanin can produce the wide range of human skin colors observed. When light hits the skin, part of the light is reflected by the melanin, and this reflection can be used to detect the pigmentation level of the skin.

[0322] In some embodiments, eye treatment device 200 may shine light 211 on the skin, and integrated visualization device 160 may view and / or record the skin as light 211 reflects from the skin. Since there are differences in reflection between different skin types or skin pigmentation, integrated visualization device 160 may be used to detect pigmentation.

[0323] Spectroscopy is the study of how matter absorbs, transmits or reflects light. Spectroscopy can be used to detect skin pigmentation. Since different skin pigmentations have unique reflectance properties, we can determine skin pigmentation by analyzing the light reflectance properties.

[0324] In some embodiments, the eye treatment device 200 is configured to detect whether the eyelid is properly captured in the correct position for treatment. In some embodiments, the detection of proper eyelid capture can be achieved by a visual device, such as using an amplifier 1804 or an integrated visualization device 160. In some embodiments, the detection of proper eyelid capture can be accomplished using one or more contact sensors 238. The integrated visualization device 160 can be used to obtain direct visualization of the eyelid and can be used to determine whether the eyelid is properly positioned for the desired treatment or routine. In addition, the eye treatment device 200 can include an image recognition feature that can use an image from the integrated visualization device 160 to determine whether the eyelid is properly positioned. The contact sensor 238 can be configured to deactivate the eye treatment device 200, and / or the eye treatment device 200 can use a light, a buzzer, or other notification means to signal the user or ECP to stop treatment. For example, the contact sensor 238 can be configured to provide information to the user or ECP using a signal from one or more outputs. These outputs can be configured to display light in one or more colors or to display sound in one or more tones. These outputs may be configured to display different light or sound patterns, to change the intensity of the light or sound, to provide a combination of light and sound, or otherwise configured to indicate different states or modes of eyelid capture. In embodiments, the contact sensor 238 may be configured to communicate eyelid capture information to other medical devices and / or communication devices.

[0325] Fig.26A An embodiment of an integrated visualization device 160 for photographing the surface of the eyelid margin and the eyelid margin to detect blocked meibomian glands is shown. Multiple factors are considered when evaluating the meibomian glands. These factors include the percentage of partial glands, the presence of chalazions, and the number of glands present within the eyelid margin.

[0326] The photographs can be used for a meibomian score (MG score), which can correspond proportionally to the area of ​​destruction. The score range can be 0 to 3, where 0 indicates that the lid margin has no partial or missing glands, 1 indicates that the lid margin area is less than 33%, 2 indicates that the lid margin area is between 33% and 66%, or 3 indicates that the area involved covers more than 66% of the lid margin. The values ​​obtained for the upper and lower eyelids are added together to obtain a score ranging from 0 to 6.

[0327] In some embodiments, integrated visualization device 160 can also be used during treatment to record the discharge of meibum from the gland as the gland is heated and compressed by ocular treatment device 200. The discharged meibum is graded as follows: 0 indicates clear meibum that is easily discharged; 1 indicates cloudy meibum that is gently discharged; 2 indicates cloudy meibum that can be discharged with more than moderate pressure; and 3 indicates meibum that may not be discharged even with strong pressure. The discharged meibum material can be used to diagnose other conditions, such as blepharitis, eyelid margin abnormalities, eyelid margin irregularities, eyelid margin thickening, partial glands, and / or gland shedding, etc.

[0328] In some embodiments, the integrated visualization device 160 can also use IR light to locate the meibomian glands and determine whether the glands are filled with materials that may have a different NIR response than the surrounding tissue. For example, the use of a sophisticated, high-resolution NIR camera should be sufficient to distinguish tissue areas from glandular areas. The wavelength and optics used by the NIR camera should be selected to provide suitable imaging of the meibomian glands and can be optimized experimentally. In addition, it may be advantageous to digitally process the resulting images to enhance contrast levels and / or assign colors to distinguish the NIR responses of individual tissues.

[0329] Image enhancement techniques have been widely used in many applications of image processing where the subjective quality of an image is important for human interpretation. Contrast is an important factor in any subjective assessment of image quality. Contrast is created by the difference in brightness 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 from other objects. Many algorithms have been developed to achieve contrast enhancement and applied to problems in image processing. One algorithm is the stretching algorithm that can be used to increase the contrast of an image and also improve brightness.

[0330] When the eyelid is viewed in reverse, it has a curved surface. When a photo of the curved surface is taken, some areas are clear and other parts are blurred. One option is to physically flatten the curved eyelid surface. Another option is to use different photography techniques for the curved surface. In order to physically flatten the eyelid, a transparent flat element, such as glass, can be used. Once the eyelid is reversed, a transparent flat element can be pressed on the eyelid surface to make it flat for the camera. One method of taking photos of the curved surface of the everted eyelid is focus stacking. Focus stacking is a digital image processing technique that combines multiple images taken at different focal lengths to provide a resulting image with a depth of field (DOF) greater than any individual source image. The starting point of focus stacking is a series of images captured at different focal depths. In each image, different areas of the everted eyelid are clear. Although none of these images are completely clear samples, they together contain all the data required to generate clear images of all eyelid parts. The clear area of ​​each image can be automatically detected or manually selected, for example, via edge detection or Fourier analysis. The clear patches are then blended together to generate the final image of the eyelid.

[0331] Image Interpretation A common technique as part of the medical diagnostic process is visual interpretation. Visual interpretation makes the process dependent on the observer. Human visual perception of an image depends on a small set of image characteristics: brightness, contrast, sharpness, saturation, and dynamics. To improve the readability of the image and reduce factors that affect information extraction and perception, the image is enhanced. Image enhancement refers to a technique that improves or modifies a digital image so that the resulting image is more suitable for a specific 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 method of modification, and the range of possible attribute values ​​are specific to a given task. One technique used for image enhancement is high dynamic range (HDR) imaging. HDR imaging methods compensate for detail loss by taking multiple photos at different exposure levels and stitching them together to create an image that presents the maximum amount of detail in dark and bright areas. Another technique used for image enhancement is pseudocolor. The purpose of pseudocolor is to exploit the perceptual capabilities of the human visual system to extract more information from an image (e.g., an image of the eyelid). The term "pseudocolor" or "false color" is used to distinguish the process of assigning color to a monochrome image from the process associated with true color images. False color processing can significantly improve the detectability of faint features, structures, and patterns in an image by providing image details that would otherwise go unnoticed.

[0332] Fig.26BAn embodiment of a stationary eyelid lining 300 is shown that allows viewing of the inside of the eyelid 14 and transillumination of the meibomian glands from behind the eyelid 14. In some embodiments, the reflective surface of the stationary eyelid lining 300 can also be configured for viewing the inside surface of the eyelid 14 with the visualization device 160. In some embodiments, viewing the inside surface of the eyelid 14 includes transillumination of the eyelid 14 and the meibomian glands. The image converter 155 allows viewing of the inside of the eyelid 14 and transillumination of the meibomian glands from behind the eyelid 14.

[0333] For example, illumination energy 170 (which may be visible light or infrared light) passes through the eyelid 14 and thus the meibomian gland 18, reflects off the reflective surface of the stationary eyelid lining 300, and ultimately reflects off over the limbus 14a. In this manner, the reflective surface allows a transilluminated image 190 of the inside of the eyelid 14 to be viewed under direct visualization or with the aid of a magnifying element or camera (collectively shown as a visualization device or visualization means 160) without everting the eyelid 14. Figure 2F yes Fig.26B The illustrated embodiment is a front view showing a transilluminated image 190 of the meibomian glands.

[0334] Some medical devices may carry bacteria, which may lead to infection or cross contamination. Antimicrobial coatings, such as antibiotics or silver particles, on the ocular treatment device 200 can reduce the risk of infection. In some embodiments, the ocular treatment device 200 and / or the sterilized disposable component 260 include one or more antimicrobial coatings to prevent cross contamination or the spread of bacteria.

[0335] In some embodiments, the sterile disposable 260 can be used to treat both eyes of a patient. The sterile disposable 260 should be treated with a disinfectant to prevent cross contamination between eyes. Wiping the sterile disposable 260 between eyes also cleans any fluid or eyelid discharge from the sterile disposable 260.

[0336] In some embodiments, the device includes a capacitive sensor or contact sensor 238 or other proximity sensor for sensing the position of the eye treatment device 200 relative to the patient's eyeball 20 or eyelid 14. In some embodiments, the contact sensor 238 may include one or more electrodes configured to sense capacitance and / or capacitance changes when the contact sensor 238 touches the eyeball 20 or eyelid 14. In some embodiments, the contact sensor 238 may include a micro switch or a force or pressure contact sensor 238, all of which produce a change in signal characteristics when the contact sensor contacts the skin of the eyeball 20 or eyelid 14. Therefore, the contact sensor 238 can be used to help determine the placement of the eye treatment device 200.

[0337] To treat the inner eyelid, the eyelid liner 300 should be in contact with the inner surface of the eyelid. To detect this, some embodiments of the eye treatment device 200 include a capacitive sensor or contact sensor 238 for detecting whether the eyelid liner 300 is in contact with the inner eyelid or the eyeball. If the contact sensor 238 detects the eyeball or is too close to the eyeball, the eye treatment device 200 can signal the user to pull further outward toward the eyelid. If the contact sensor 238 detects contact with the eyelid, the eye treatment device 200 is in the correct treatment position.

[0338] In some such embodiments, the controller is programmed to prevent ocular treatment device 200 from being activated until the controller detects that ocular treatment device 200 is properly placed adjacent to the inner eyelid via a signal from contact sensor 238. Additionally, in some embodiments, the controller is programmed to deactivate energy when a signal received from contact sensor 238 causes ocular treatment device 200 to no longer be properly placed on the eyelid.

[0339] To insert the stationary eyelid lining 300 behind the eyelid, many people pull on their eyelashes to lift the eyelid away from the eyeball to insert the eyelid lining 300. Many times, this method pulls out the eyelashes and causes pain.

[0340] In some embodiments, a suction device can be attached to the outer surface of the eyelid and can pull the eyelid upward to make room for the eyelid lining 300. Once the eyelid lining 300 is in place, the suction device can be detached and removed. For example, lifting the eyelid with the suction device may include: placing a suction portion of the suction device on the outer eyelid; generating suction to engage the outer eyelid skin; pulling the eyelid away from the eyeball; and releasing the suction and removing the suction device once the eyelid lining 300 is inserted behind the eyelid.

[0341] In some embodiments, a pulling device with a curved or hooked tip can slide behind the eyelid and pull the eyelid away from the eyeball to make room for the eyelid lining 300. Once the eyelid lining 300 is in place, the pulling device can be removed.

[0342] In some embodiments, the sterile disposable component 260 or the eyelid liner 300 may have a lifting feature, such as a curved tip, a hook, or other similar feature, for lifting the eyelid away from the eyeball. The lifting feature may be incorporated into the design of the eyelid liner 300 or may be an add-on part. Lifting the eyelid with the lifting device may include: sliding the lifting feature on the distal end of the lifting device behind the eyelid; lifting the eyelid away from the eyeball; and removing the lifting device once the eyelid liner 300 is inserted behind the eyelid.

[0343] In some embodiments, the sterilized disposable component 260 or the eyelid inner pad 300 may include a light source for viewing the eyelid, such as for transillumination or tarsography. For example, for transillumination, a light feature on the sterilized disposable component can shine light onto one side of the eyelid (such as the inner eyelid), allowing the user to view the glands of the eyelid. In the following embodiments, infrared light is projected onto or through the everted eyelid, and an IR-sensitive camera is used to view the meibomian glands. For tarsography, the sterilized disposable component 260 may include an LED infrared light source that shines on the eyelid so that the camera captures an image. Tarsography provides a view of all meibomian glands in the eyelid. In some embodiments, the light source is provided with blue or violet light in the range of 400-450nm to reduce and / or eliminate bacteria.

[0344] Fig. 27 One embodiment of a reflective eyelid lining 300 is shown that can be positioned between the eyelid 14 and the eyeball 20 to cover the sensitive anatomy of the eye system 10 to prevent light from contacting the eye. The eyelid lining 300 is designed to receive light energy transmitted through the eyelid 14 and reflect it back to the inner surface of the eyelid to warm it.

[0345] The reflective inner eyelid pad 300 may include a set of temperature sensors 310 positioned toward the inner eyelid. The sensors may be discrete components embedded or positioned in the inner eyelid pad 300 (such as thermocouples made of very fine wires, or micro-thermistors), or may be thermocouples formed by depositing a suitable metal film on an intermediate layer of the inner eyelid pad 300.

[0346] To prevent the reflective inner eyelid pad 300 from warming or heating the sensor, the energy reflective surface includes a sensor window for the sensor to extend through and directly contact the inner eyelid surface.

[0347] In some embodiments, the reflective eyelid liner 300 can be used as a mirror to allow viewing of the inside of the eyelid 14 through a visualization device and transillumination of the meibomian glands from behind the eyelid. In some embodiments, the eyelid and meibomian glands can be transilluminated using reflected light from the reflective surface of the eyelid liner 300.

[0348] Fig. 27 Also shown is a portion of a sterilized disposable component 260 having an eyelid inner pad 300 that may include an energy absorbing front surface 302 to warm the inner eyelid. The energy absorbing front surface 302 may include a light source for heating. In some embodiments, the light source may be on the eyelid inner pad 300 and directed toward the inner eyelid to warm the gland. For example, the light source may emit a wavelength in the range of about 500 nm to about 600 nm to achieve the highest absorption of light in the tissue.

[0349] In some embodiments, the energy absorbing front surface 302 may include a light pipe and / or other reflective elements configured to direct heating light toward the inner eyelid pad 300 and shine the light onto the inner eyelid to heat the meibomian glands behind the eyelid.

[0350] In some cases, the meibomian glands may be inflamed or dysfunctional, so it may be desirable to obtain a meibum sample for analysis. For example, the meibomian glands may be inflamed due to increased production of meibum by the omega-6 essential fatty acid component. Additionally and / or alternatively, the meibomian glands may have bacteria in them and may cause inflammation. For these cases, the eye treatment device 200 or the sterilized disposable component 260 may include a sample receiving portion configured to obtain a meibum sample as it is discharged. For example, the sample receiving portion may be a meibum reservoir in the sterilized disposable component 260 that receives meibum. In some embodiments, there may be multiple sample receiving portions, such as one for each eyelid. Once obtained, the meibum sample may be tested. In an embodiment, the test may include contacting the meibum with a color-sensitive marker that uses color to indicate the presence of bacteria. If bacteria are present, the ECP may develop a treatment plan. Additionally and / or alternatively, a camera may help obtain a meibum sample. For example, a camera may view the meibum as it is discharged by taking a photo or video to record the capture of the meibum sample.

[0351] From children to adults, the size of eyes and eyelids varies. To accommodate this, the disposable eyelid inner pad 300 can be made in different sizes. For example, there can be a child size, a small adult size, a medium adult size, and a large adult size.

[0352] Fig.28A and Fig.28B Another embodiment of an eye treatment device 200 is shown. In some embodiments, the eye treatment device 200 and the sterile disposable component 260 can be rotated 180 degrees between treating the lower eyelid and the upper eyelid. As a result, all controls on the eye treatment device 200 will also rotate so that when treating the upper eyelid, the controls are upside down. This may be a problem for some users. Fig.28A and Fig.28B As shown, one option to avoid this potential problem is to rotate the sterile disposable portion 260 180 degrees while the handheld instrument 1800 remains stationary, so that the eye treatment device 200 is in one position and the sterile disposable portion 260 can be in two positions.

[0353] In some embodiments, it may be desirable to warm or heat the meibomian glands without squeezing the eyelids. For example, the eye treatment device 200 may be designed as a non-contact infrared heating device using IR LEDs and may be configured to heat the meibomian glands within the eyelids without squeezing the eyelids.

[0354] To summarize the present disclosure, preferred aspects, advantages and features have been described herein. It should be understood that not all such advantages may be achieved according to any particular embodiment. Thus, the disclosed apparatus and methods may be implemented or practiced in a manner that achieves one advantage or group of advantages as taught herein without necessarily achieving other advantages as may be taught or suggested herein.

[0355] Although the present disclosure has been described in conjunction with embodiments currently considered to be practical, it will be appreciated by those skilled in the art that various modifications and changes may be made without departing from the scope of the present disclosure. It will also be appreciated by those skilled in the art that portions mixed with one embodiment may be interchangeable with other embodiments; one or more portions of the depicted embodiments may be included in any combination by other depicted embodiments. For example, any of the various components described herein and / or depicted in the accompanying drawings may be combined, interchanged, or excluded from other embodiments. With respect to the use of substantially any plural and / or singular terms herein, those skilled in the art may appropriately convert from the plural to the singular and / or from the singular to the plural, depending on the context and / or application. For clarity, various singular / plural arrangements may be explicitly set forth herein.

[0356] While this disclosure has described certain exemplary embodiments, it should be understood that this disclosure is not limited to the disclosed embodiments, but on the contrary is intended to cover various modifications and equivalent arrangements included within the scope of the appended claims and their equivalents.

Claims

1. A device for treating a mammalian eye having an eyelid, the device comprising: Sterile disposable components with: a front plate positionable adjacent an outer surface of the eyelid, the front plate being made of a transparent material that transmits light of the wavelengths emitted by the energy converter, the front plate further comprising a sensor configured to provide information regarding a position of the eyelid relative to the front plate; a rear plate positionable adjacent an inner surface of the eyelid, the rear plate being made of or coated with an energy reflective material configured to receive light energy of a first wavelength transmitted through the eyelid and reflect it back toward the eyelid, the rear plate further comprising a sensor configured to provide information regarding a position of the eyelid relative to the front plate; as well as attaching tabs; as well as Handheld instruments, including: the energy converter having means for emitting a plurality of wavelengths of light energy, the wavelengths including a first wavelength selected to pass through the eyelid and a second wavelength selected to be absorbed by the eyelid to increase temperature; at least two latches for grasping attachment tabs of the sterile disposable component to secure the sterile disposable component to the handheld instrument; and an actuator controlled by a compression control button such that the actuator controls movement of a movable shield configured to transmit light energy emitted from the energy converter and wherein a front plate of the sterile disposable component is attached to a front portion of the shield when the sterile disposable component is attached to the handheld instrument; wherein, when the eyelid is located between the front plate and the back plate, the light energy from the energy converter heats the target tissue region to a temperature sufficient to melt meibum in the meibomian glands located in or adjacent to the target tissue region; and Wherein, when the compression control button is pressed, the shield and the front plate are pushed toward the rear plate and squeeze the eyelid so that the meibum is discharged from the meibomian gland.

2. The device according to claim 1, wherein: The actuator is coupled to the front plate and the rear plate, and is configured to generate relative movement between the front plate and the rear plate to squeeze the eyelid so that the meibum is discharged from the meibomian gland.

3. The device as claimed in claim 2, wherein: The actuator is further configured to control the amount of optical energy at the second wavelength emitted by the energy converter, thereby controlling heating of the target tissue.

4. The device according to claim 1, wherein: The energy converter is further configured to provide light energy at a third wavelength selected to treat bacteria.

5. The device of claim 1, further comprising a visualization device for observing the eyelid during treatment.

6. The device according to claim 1, wherein: The energy converter includes at least one of: an LED, a laser, an incandescent lamp, and a gas discharge lamp.

7. The device of claim 1, further comprising one or more components selected from the group consisting of: a display or dashboard configured to display the status of the device; a temperature measuring device configured to measure various temperatures of the eyelid, including the eyelid inner surface temperature and / or the eyelid outer surface temperature; A data logger; a voice recorder; a battery configured to power components of the apparatus; a battery charging device; Controller; a printed circuit board; and communication circuitry between the backplane and the energy converter.

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