![]() HEATING SET AND HEATING SYSTEM
专利摘要:
SET AND TREATMENT SYSTEM FOR DRY EYE SYNDROME. Dry eye treatment apparatus and methods are described herein, which generally comprise a patch or strip affixed to the skin of the upper and/or lower eyelids to deliver heat or other forms of energy, pressure, drugs, moisture, etc. (alone or in combination) to one or more meibomian glands contained within the underlying skin. The treatment strip or strips may include one or more strips configured to adhere to an underlying region of skin in proximity to one or both of an individual's eyes such that the one or more strips allow the individual to blink naturally without restriction of one. or more plasters. Furthermore, the one or more strips can be configured to emit energy to the underlying region of the skin and wherein the one or more strips are shaped to follow a location of the one or more meibomian glands contained within the underlying region of the skin. 公开号:BR112014016505B1 申请号:R112014016505-0 申请日:2012-10-09 公开日:2021-05-18 发明作者:Paul Badawi 申请人:Sight Sciences, Inc; IPC主号:
专利说明:
CROSS REFERENCE TO RELATED PATENT APPLICATIONS [001] This is a continuation in part of US patent application filed January 4, 2012 and a continuation of US patent application 13/645,985 filed October 5, 2012, the contents of which are incorporated here as a reference in its entirety. FIELD OF THE INVENTION [002] The present invention relates to methods and apparatus for treating dry eye syndrome and other related conditions. More particularly, the present invention relates to methods and apparatus for treating dry eye syndrome using adhesive strips that are specifically designed or molded to adhere to regions around the periorbital region or the patient's eyes. HISTORY OF THE INVENTION [003] Tears are a complex mixture of water, lipids, mucus, proteins and electrolytes and this mixture helps to maintain an even and clear optical surface and also helps protect the eyes from infection. Tear film has three basic layers: oil, water and mucus and problems or disturbances in any of these layers can cause symptoms of dry eyes. [004] The outermost layer of the tear film is typically comprised of an oil layer containing fatty acids and lipids (meibum) which are mainly produced by the sebaceous glands called the meibomian glands located along the margin of the eyelids. The oil layer smoothes the tear surface and slows down the evaporation of the aqueous middle layer. However, if the meibomian glands fail to produce enough oil, produce sub-optimal fatty acid mixtures, or if the glands become clogged or clogged, the water layer typically evaporates too quickly causing dry eyes. A blockage of the meibomian glands can lead to enlarged glands or infections. Dry eyes are thus common in people whose meibomian glands are clogged or malfunctioning. [005] The middle layer of tears is mainly composed of an aqueous solution, which is produced by the tear glands (tear glands). The middle layer cleans the eyes and washes away external or irritating particles, maintains a clean optical medium, and keeps the ocular surface moist. The innermost layer of the tear film is mainly made up of mucus which helps to disperse tears evenly over the surface of the eyes. Lack of mucus in the tear film is also associated with dry eye syndrome. [006] As discussed above, the meibomian glands are excretory oil glands located within both the upper and lower eyelids. There are approximately 30 to 40 glands along the upper eyelid and approximately 20 to 30 glands along the lower eyelid with the ducts to each of the glands opening along the inner edge of the free margin of the respective eyelids per minute through which its secretion is released to prevent eyelids from sticking together. An example of the location of the meibomian glands is illustrated in the cross-sectional view of the upper eyelid UL shown in Fig. 1A which illustrates the relative positioning of a single meibomian gland MG. Other glands and anatomical features are illustrated for reference, eg Wolfring's glands GW, tarsus TR, Moll's gland GM, Zeis's gland GZ, Krause's GK gland, superior fornix UF, conjunctiva CN and cornea CR of the eye which is partially covered by UL upper eyelid. As illustrated, the MG meibomian gland is positioned along a length of the upper eyelid UL (and lower eyelid LL) with the duct opening along the inner edge of the upper eyelid UL in proximity to an underlying eye surface. [007] Fig. 1B illustrates a front view of a patient's eye having the upper eyelid UL and lower eyelid LL in a closed position, such as when the patient blinks. As shown, the MG meibomian glands can be seen aligned adjacent to each other on both the upper UL and lower LL eyelids. Fig. 1C also shows a perspective view of a patient's eye in the open position to illustrate how the meibomian glands are typically aligned relative to one another when the patient's eye is open. [008] Blinking is considered the main mechanism to open the orifice of the meibomian glands to allow the release of oil secretions to the glands. The natural blinking movement and the strength of the blink causes the upper eyelid to pull a sheet of lipids secreted by the meibomian glands over the two underlying layers of the tear film thus forming the protective coating that limits the rate at which the underlying layers evaporate. It is estimated that approximately 65% of meibomian gland diseases or dry eye result from a defective lipid layer or an insufficient amount of such lipids which results in accelerated evaporation of the aqueous layer. Consequently, blink disorders or other disorders that affect proper tear distribution can also cause or exacerbate meibomian gland dysfunction or dry eye. [009] As the eyelids close in full blinking, the upper and lower fornices, which maintain a reservoir of tears, are compressed by the force of the preseptal muscles and the eyelids move toward each other. The upper eyelid, for example, moves over the eye while exerting a force on the surface of the eye that helps clear the front of the eye of debris, insoluble mucin, and also expresses oil secretions from the meibomian glands. The lower eyelid moves horizontally towards the nose and pushes the debris towards both lacrimal points, the openings that finally drain into the coupler cavities. [010]As the eyelids open, the tear film is redistributed where the upper eyelid pulls the water phase through capillary action and the lipid layer spreads out as quickly as the eyelids move. Consequently, eyelid movement is therefore important in tear film renewal, distribution, regeneration and drainage. [011] For a variety of reasons, the meibomian glands can become blocked, plugged, or occluded resulting in meibomian gland dysfunction and dry eye disease. The obstruction that triggers the disease can occur anywhere within the meibomian gland, for example, on the surface of the gland or orifice preventing normal lipid secretions from flowing; in the main channel of the gland which may be narrowed or blocked; or at other deeper places within the gland that lead to the main channel. [012] Treatments for blocked meibomian glands can include a number of conventional treatments. A course of treatment includes applying soap and cleansing agents, washing the eyelids, or antibiotics to reduce eyelid inflammation. Antibiotics such as tetracycline, doxycycline, metronidazole or erythromycin can be administered orally or topically to help regulate or improve lipid production in the meibomian gland. Inflammation over the surface of the eye can also be controlled with optical drugs such as corticosteroids or cyclosporine (RESTASIS®, Allergan, Inc., CA) or other anti-inflammatory or immunosuppressive compounds. Evidence suggests that inflammation of the ocular surface is not only associated with meibomian gland dysfunction, but also dry eye syndrome. [013]Other examples of dry eye treatments may include applying prescription eye inserts to people with moderate to severe symptoms of dry eyes who cannot use artificial tears. An ocular insert, eg, hydroxypropyl cellulose (LACRISERT®, Merck & Co., Inc., NJ), can be inserted between the lower eyelid and the eye. The insertion slowly dissolves to release a substance that lubricates the eye. Alternatively, special contact lenses can be used to protect the surface of the eye to trap moisture. [014] In other treatments, the patient's tear ducts can be closed to prevent the tear film from draining from the surface of the eye too quickly through procedures such as inserting punctal plugs into the tear ducts or cauterizing tissue in the area of drainage. In addition to implants or cautery treatments, dry eye syndrome can be treated using pharmaceutical agents such as eye drops, ointments that coat the eyes, etc. Artificial tears, gels, ointments, autologous serum tears, or albumin drops have been used in the treatment of dry eye. [015] Additionally, warm compresses are also typically placed over the eyes and are used to restore the function of the meibomian glands by melting any lipid plugs, as well as incorporating eyelid massage which can further expel the contents of the glands. meibomians. However, applying a hot compress requires applying it two to three times daily during which time patients may incorrectly target only one of the affected eyelids and are also prevented from seeing through the treated eye because of the compresses. The compresses can be too hot, further exacerbating the inflammation, or they can cool down quickly preventing adequate therapeutic effect. [016]Other treatment devices have also been developed that cover the entire affected eye to apply heat and massage force directly to the affected eyelids. However, such devices, like swabs, require the patient's eyes to be temporarily but completely obstructed during treatment resulting in discomfort, lost productivity and potentially lower acceptance among patients. Additionally, these treatments require visits from a physician or healthcare provider and are not suitable for broad consumer adoption. [017] Thus, there is a need for methods and devices that are relatively simple to use routinely for the patient, that also allow the patient to continue their normal activities, are non-obstructive and non-interruptive, and that also have the advantage that the patient's natural physiological activities facilitate treatment. SUMMARY OF THE INVENTION [018] In treatment conditions, such as meibomian gland dysfunction or dry eye syndrome, a patch or strip may be attached to the skin of the upper and/or lower eyelids to carry heat or other forms of energy, pressure, drugs, humidity, etc. (alone or in combination) to one or more meibomian glands contained within the underlying skin. In particular, the set for the treatment strip or strips may generally comprise one or more strips configured to adhere to an underlying region of skin in proximity to one or both of an individual's eyes such that the one or more strips enable the individual blinks naturally without restriction of one or more patches. Furthermore, the one or more strips can be configured to emit energy to the underlying region of the skin and wherein the one or more strips are shaped to follow a location of the one or more meibomian glands contained within the underlying region of the skin. [019] In use, one or more strips may adhere to a region of skin in proximity to one or both of an individual's eyes so that the one or more strips allow the individual to blink naturally without restriction of one or more plasters. While adhered, the strips can emit energy to the skin region, whereby the one or more strips are shaped to follow a location of the one or more meibomian glands contained within the skin region. Alternatively, while the strap may not directly overlap a meibomian gland or other ocular or orbital gland, it may carry energy or absorb energy from the nearby underlying vasculature that ultimately serves those glands. In other words, heating or cooling the blood supply to the eyelids, meibomian glands and/or lacrimal glands using these strips can affect their function and metabolism while not necessarily needing to directly overlap them in particular variations. [020] The upper strap thus may have a curved or arcuate upper periphery that is shaped to extend and follow the upper (or upper) edge of the meibomian glands (such as along or above the upper eyelid crease) while the straight periphery of the lower edge can be shaped to extend and follow the lower (or lower) edge of the meibomian glands, such as along the free edge of the upper eyelid. Although the straight bottom edge can be slightly curved or arched in alternative variations. The lower strap may similarly have a straight upper periphery to extend and follow the upper (or upper) edge of the meibomian glands along the free margin of the lower eyelid and a curved or arched periphery to extend and follow the lower (or lower) edge. ) from the meibomian glands along the lower eyelid (such as along or above the lower eyelid crease). Alternatively, the upper periphery of the lower strap can also be slightly curved or arcuate in alternative variations. [021] In other words, with the tarsal plate containing the meibomian glands that expand from proximal to distal, the peripheral edges of the treatment strips can correspond to the distal edge of the eyelid and the proximal peripheral edge and the treatment strips can assume multiple settings. Generally, the distal peripheral edge of the treatment strip can be relatively straight or assume a slight curve, both of which can follow the underlying distal edge of the eyelid while having a proximal peripheral edge that is relatively curved to assume the more curved proximal edge of the plate. underlying tarsal. [022] The strips can be used individually for placement over only the upper eyelid or just the lower eyelid depending on the desired treatment. In addition, the lengths of the treatment strips can also be varied to target individual meibomian glands to provide targeted treatment, if desired, and as described in more detail here. Additionally, while treatment strips can be sized generally, they can also be customized or sized to specific individual eyelid dimensions. [023] Due to the specific delineated sizes and flexibility of the treatment strips the treatment strips can be placed over the patient to apply therapy to the underlying meibomian glands allowing the patient's eyes to be opened and closed normally without interference from one or both the treatment strips. In this way, the outlined size, shape and flexibility of the treatment strips allow treatment to take place while also allowing the patient to keep one or both eyes open so that normal physiological blinking can proceed during the course of treatment. Rather than relying on an application of any kind of external force, the treatment strips take advantage of the eye's natural mechanism to cleanse oil from the meibomian glands through blinking. Consequently, the treatment strips can be adhered in place for treatment without any further intervention by the patient or healthcare provider so that the treatment strips can apply, for example, heat energy to melt or liquefy any wax or clogs. solids from the meibomian gland while the eyes remain unobstructed and are allowed to blink naturally. Treatment strips thus allow the strength of natural blinking to clear the glands of softened blockages treated by heat before they solidify again unlike other treatments that require the patient to keep the eyes closed or obstructed during the course of a treatment and prevent or inhibit the patient from blinking. [024] The treatment strip can be configured to have a contact layer (for example, fabricated from conductive materials such as metals, alloys, porous ceramics, engineering ceramics, woods, polymers, composites, foams, polymer foams , fabrics, elastomers, etc.) that can protect the skin from burns or any other adverse effects. A second heating layer can be positioned above the contact layer (or directly in contact with the skin) to generate heat energy and an insulating layer can be positioned above the heating layer to focus, direct, or reflect heat towards the adjacent skin surface, as well as protecting the patient from contact with the heating layer of other parts of the body. The insulating layer can thus be manufactured from a variety of insulating materials, e.g. foams, foam tapes, gauze, silicone, micro-porous polyethylene films, fabrics, polymers, etc. [025] Although the application of heat energy from the treatment strips is described, other variations may alternatively include the application of using the treatment strips to cool the underlying skin. Instead of using the heating layer in an exothermic reaction, the layer can be configured to use the endothermic reaction instead to provide cooling to the skin. Cooling, unlike heating, can be applied for conditions such as reducing inflammation, alleviating allergies or tired eyes, etc. particularly as the patient rests or sleeps. [026] In addition to the application of heat energy from the treatment strips, the strips can also include a layer for the diffusion or release of one or more pharmaceutical, biological or chemical agents alone or in combination with the heat treatment. For example, pharmaceutical, biological or chemical agents can be incorporated either in the contact layer, insulating layer or in a completely separate layer for transdermal administration to the meibomian glands or to the areas around the meibomian glands for additional and/or alternative treatments. In the event that the pharmaceutical or chemical agent is released during heat treatment, the heat can help improve the penetration of any drugs into the underlying skin. [027]While treatment strips can incorporate several layers into the strips to effect several different treatments, the strips can also be varied in size, shape, contour etc. depending on the desired treatment areas as long as the treatment strips are delineated or shaped to follow the location of at least one meibomian gland. [028]While treatment strips can be applied to one or more of the meibomian glands, variations of the strip can also be used to treat other glands, such as the sebaceous glands, eg acne treatment. The treatment strips used to treat acne can use different pharmacological treatments. Additionally, treatment strips can be used to potentially treat eye disorders in addition to meibomian gland dysfunction. [029] Yet another example may include the use of treatment strips to treat disorders of the tear gland and/or eyelid tear gland that are located above the eye. Variously sized treatment strips, such as tear gland strips that are sized to have a curved upper periphery, can be sized for placement directly on the surface of the skin above where the tear glands are located. The lacrimal glands and/or the eyelid lacrimal gland can be treated alone or in combination with the treatment strips designed for treating the meibomian glands. [030]While treatment strips can be applied over the meibomian glands to apply heat energy, the treatment does not require the application of any external force applied by the strip or any other external device, but can utilize the patient's natural blinking to facilitate the treatment. However, in additional variations, the treatment strips can be configured to apply both heat treatment as well as an external force. Any number of mechanisms can be used to apply a compressive or polarizing force to provide compression of the underlying skin of the meibomian glands during the application of heat therapy. [031] In addition to a compressive force, the strip can be formed with alternative components, such as a mechanical component to transmit vibrational energy or other forms of energy to facilitate the expression of the meibomian glands and promote oil secretion. [032] In yet another variation, one or both of the treatment strips can be configured to incorporate an indicator, for example, LED light, vibrating element, etc., electrically coupled to a power supply and/or processor to alert the patient when a prescribed treatment has been completed. This aspect (and any of the other aspects) can be combined with any of the other variations of the treatment strips described herein as practicable. [033] With the implementation of a processor in treatment strips, treatment times and other parameters such as strip temperature can be programmed and optionally start or stop selectively by the patient or automatically. In addition, other parameters such as the frequency of heat administration or other stimulus can also be programmed by the processor to provide more flexibility to the treatment. BRIEF DESCRIPTION OF THE DRAWINGS [034] Fig. 1A shows a cross sectional side view of an upper eyelid and an example of the location of a meibomian gland. [035] Fig. 1B shows a front view diagram of the distribution of the meibomian gland in the human eyelids having the upper eyelid and the lower eyelid in a closed position, such as when the patient blinks, and the alignment of the meibomian glands on both sides. upper and lower eyelids. [036] Fig. 1C shows a perspective view of a patient's eye in the open position to illustrate how the meibomian glands are typically aligned relative to one another when the patient's eye is open. [037] Fig. 2A shows a front view of a patient's eye in a closed position with an example of treatment strips that adhere over the upper or lower eyelids (or both) and where the strips are sized or outlined to placement directly over the meibomian glands located in the underlying eyelids. [038] Fig. 2B shows the treatment strips of Fig. 2A illustrating how the strips can remain adhered to the patient's skin while allowing the eyelids to retract and allowing the patient to continue blinking while viewing normally through the eyes. While the strips can be applied from the eyelid margin to the eyelid crease, they can alternatively flex or contract and/or compress during blinks to prevent impairment of normal blinking and maximize comfort. [039] Fig. 3A shows an example of outlined treatment strips. [040] Fig. 3B shows an example of a cross sectional side view of a treatment strip. [041] Fig. 3C shows another variation of a treatment strip that can optionally incorporate a controller. [042] Fig. 3D shows yet another variation in which a treatment strip can be formed in a zigzag or curved configuration to facilitate patient blinking. [043] Fig. 4 shows a front view of another variation of the treatment strip that is relatively thin and positioned over the upper eyelids. [044] Fig. 5 shows a front view of another variation of the treatment strip that is relatively thick for treating the targeted meibomian glands as well as surrounding tissue. [045] Fig. 6 shows a front view of another variation of the treatment strip that is designed to more closely follow the meibomian glands in the upper eyelids. [046] Fig. 7 shows a front view of another variation of the treatment strip that can be formed into shortened strips for selective placement along the eyelids. [047] Fig. 8 shows a front view of another variation of the treatment strip that is relatively thin and outlined for placement along the lower eyelids. [048] Fig. 9 shows a front view of another variation of the treatment strip that is relatively thicker and also outlined for placement along the lower eyelids. [049] Fig. 10 shows a front view of another variation of the treatment strip that is relatively thick for placement along the lower eyelids. [050] Fig. 11 shows a front view of another variation of the treatment strip that is delineated for the lower eyelids and that can be shortened to various lengths. [051] Fig. 12 shows a front view of another variation of the treatment strip that is relatively straight and selectively shortened. [052] Fig. 13 shows a front view of another variation of the treatment strip that is outlined and further illustrates how differently sized strips can be used in combination with one another. [053] Fig. 14 shows a front view of another variation of the treatment strip that is sized to follow not only the meibomian glands along the lower eyelid, but also the surrounding tissue regions. [054] Fig. 15 shows a front view of another variation of the treatment strip that is designed to follow the meibomian glands along the lower eyelid with surrounding tissue regions. [055] Fig. 16 shows a front perspective view of yet another variation in which the strip is designed to follow at least a part of the meibomian glands, but also cover selected regions of surrounding tissue. [056] Fig. 17 shows a front perspective view of yet another variation that is designed to selectively treat particular regions of underlying tissue. [057] Fig. 18 shows a front view of yet another variation in which the outlined treatment strips can be used in combination to treat both the upper and lower eyelids. [058] Fig. 19 shows a front view of yet another variation in which the treatment strips can be more closely changed in color to match the adjacent skin tone. [059] Fig. 20 shows a front view of yet another variation in which the treatment strips can be sized to treat specific meibomian glands. [060] Fig. 21 shows a front view of yet another variation in which the strips can be varied in size to selectively treat particular meibomian glands. [061] Fig. 22 shows a front view of yet another variation in which the treatment strips can be sized to treat individual meibomian glands. [062] Fig. 23 shows a front view of yet another variation in which the treatment strips can be sized for placement along the lower eyelids. [063] Fig. 24 shows a front view illustrating the relative positioning of the lacrimal glands. [064] Figs. 25 to 27 show variations of treatment strips that can be designed and positioned to treat the underlying tear glands. [065] Figs. 28 to 30 show variations of treatment strips that can be designed and sized to treat meibomian glands in combination with optionally treating lacrimal glands as well. [066] Figs. 31 and 32 show variations in treatment strips that can be sized to selectively treat particular meibomian glands in combination with the lacrimal gland. [067] Fig. 33 shows another variation of treatment strips that may have aspects of mechanical polarization incorporated along the strips to apply a force to the underlying tissue and meibomian glands. [068] Fig. 34 shows a detailed perspective view of the treatment strip of Fig. 33 illustrating an example of biasing mechanisms incorporated along the strips. [069] Fig. 35 shows another variation of treatment strips incorporating one or more transducers to transmit a vibrating force to the underlying tissue and meibomian glands. [070] Fig. 36 shows yet another variation of treatment strips incorporating electrodes across the length of the strips. [071] Fig. 37 shows yet another variation of treatment strips incorporating microwave antennas along the strips. [072] Fig. 38 shows yet another variation of a treatment strip incorporating a timer and prompt to alert a user when a treatment has been completed. [073] Fig. 39 shows yet another variation of an eyelid treatment system that can be coupled to a portable remote controller, such as a smartphone or tablet. DETAILED DESCRIPTION OF THE INVENTION [074] Under treatment conditions such as meibomian gland dysfunction (MGD), which is commonly associated with the evaporative form of dry eye syndrome (DES), a thin patch, strip, or adhesive device may be attached to the skin. the upper and/or lower eyelids to carry heat or other forms of energy, pressure, drugs, moisture, etc. (alone or in combination) to one or more meibomian glands contained within the underlying skin. In particular, the treatment strip or strips may be configured and sized specifically for placement over one or more of the targeted meibomian glands contained within the skin of the upper and/or lower eyelids. The application of thermal energy, eg heat or cold, can cross the eyelids quite easily as the eyelids are generally the final skin found in the human body and the tissue is highly vascularized. With the lid root located proximally and the lid margin located distally, the arterial blood flow network flows from proximal to distal. Thus, regardless of where these strips are placed, heating or cooling therapy can be easily carried along the eyelid and any structures contained therein, eg meibomian glands MG, tear glands LG, Zeis gland GZ, Moll gland GM , Wolfring GW gland, Kraus GK gland, etc. [075] Also, because the eyelid is so thin, warming or cooling therapy can be transmitted to the ocular surface and the eye itself (described in more detail below). Thus, therapy can transmit energy to the conjunctiva, goblet cells, episcleral vasculature, cornea, aqueous humor, iris, ciliary body, and possibly the anterior vitreous and lens. In this way, any thermal therapy by means of treatment strips can also impact and be used to treat ocular surface disorders and anterior segment diseases, for example, conjunctivitis, keratitis, keratopathy, iritis, cyclitis, glaucoma, cataract, etc. Also, there may be use in the post-operative state after LASIK, PRK or cataract or corneal surgery or other ocular, periocular, intraocular, or eyelid surgery, as described in more detail below. [076] As shown in the front view of Fig. 2A, a variation of such treatment strips can be seen to be temporarily adhered over the upper eyelid UL and the lower eyelid LL over an eye of a patient P when closed for illustrative purposes. The outlined top strip 10 can be sized to adhere directly to the skin of the UL upper eyelid so that the strip 10 has a configuration and shape that follows the location of one or more meibomian glands contained within the underlying skin of the UL upper eyelid. Likewise, the outlined lower strip 12 should also have a configuration and shape that follows the location of one or more meibomian glands contained within the underlying skin of the lower eyelid LL. In other variations, the outlined strip may also stop at the eyelid crease or cross it as described in other variations below. [077] The upper strap 10 may thus have a curved or arcuate upper periphery 14 that is shaped to extend and follow the upper (or upper) edge of the meibomian glands (such as along or above the upper eyelid crease) as the straight periphery 16 of the lower edge can be shaped to extend and follow the lower (or lower) edge of the meibomian glands, such as along the free edge of the upper eyelid UL. The lower strap 12 may similarly have an upper straight periphery 20 to extend and follow the upper (or upper) edge of the meibomian glands along the free margin of the lower eyelid LL and a lower curved or arcuate periphery 18 to extend and follow the lower (or lower) edge of the meibomian glands along the lower eyelid LL (such as along or above the lower eyelid crease) . The use of the terms lower and upper here refers to the periphery of the treatment strips when placed over patient P (human or animal) and are used here for descriptive purposes. [078]While treatment strips 10, 12 are both shown adhered over the respective upper eyelid UL and lower eyelid LL, the strips 10.12 can be used individually for placement over only the upper eyelid UL or only the lower eyelid LL depending on the desired treatment. In addition, the lengths of treatment strips 10, 12 can also be varied to target individual meibomian glands to provide targeted treatment, if desired, and as described in more detail here. [079] While treatment strips 10,12 are shown placed over patient P's closed eyelids, strips 10, 12 are shaped in an arc or flexible enough to assume the curvature of the patient's eyelid margin and may be long or long. enough to cover some or all of the underlying meibomian glands in the tarsal plate. While treatment strips 10, 12 can be sized generally, they can also be customized or sized to specific individual eyelid dimensions or shaped to optimize adhesion and/or comfort and/or stability. Generally, treatment strips 10, 12 can be between about 1 mm to 50 mm in length depending on the length of treatment desired as well as the anatomical considerations of the patient as the typical adult palpebral fissure length is about 27 mm to 30 mm. Thus, to cover all the meibomian glands, the treatment strips 10, 12 can be sized to have a length of, for example, 25 mm to 30 mm, or if sized to only cover in addition to all the meibomian glands, a length of , for example, 30mm to 50mm (or more if necessary to optimize adhesion/comfort/stability). In addition, one or both of the treatment strips 10, 12 may have a width ranging from about 1 mm to 25 mm whereas the typical eyelid crease in a Caucasian male is about 8 mm to 9 mm above the lid margin while in Caucasian women it is about 9 mm to 11 mm above the lid margin (or more if needed for adhesion/comfort and potentially increased effectiveness of warming or cooling incoming blood flow). Customization allows it to be adapted to any anatomy, race, ethnicity, etc. in particular. In addition, treatment strips can be manufactured with varying levels of flexibility to accommodate eyelid and eyelid blink ergonomics for optimal comfort and minimal obstruction or movement. [080] Due to the specific delineated sizes and flexibility of the treatment strips 10, 12, the treatment strips can be placed over the patient by the patient for consumer use or by a healthcare professional to apply therapy to the underlying meibomian glands allowing that the patient's eyes are opened and closed normally, as shown in Fig. 2B, without interference from one or both of the treatment strips. While the strips can be applied from the eyelid margin to the eyelid crease, they can alternatively flex or contract and/or compress during blinks to prevent impairment of normal blinking and maximize comfort. [081] Typical treatment patches, such as the application of warm compresses, are usually sized for placement over the entire eye or eyes, so that the patient is unable to open their eyes or blink during a treatment session. Also, due to the strong association between DES and MGD (eg MGD includes the spectrum of MGD, meibomite, blepharitis, and ocular rosacea), natural blinking by an individual is the mechanism by which secretions from the meibomian gland are normally released in the margin of the eyelid and over the tear. In the absence of blinking, the oil contained within the meibomian glands remains within the gland's terminal ducts and fails to contribute to the distribution of the oily layer over the tears. [082] In this way, the outlined size, shape and flexibility of the treatment strips 10, 12 allow treatment to occur while also allowing the patient to keep one or both eyes open so that normal physiological blinking can proceed during the course of the treatment. Rather than relying on the application of any kind of external force to expel oil or blockage from the glands, the treatment strips 10, 12 take advantage of the eye's natural mechanism to clear the oil from the meibomian glands through blinking. Consequently, the treatment strips 10, 12 can be adhered for treatment without any further intervention by the patient or healthcare provider so that the treatment strips 10, 12 can apply, for example, heat energy to melt or liquefy any wax or solid obstructions of the meibomian gland while the eyes remain unobstructed and are allowed to blink naturally. The treatment strips 10, 12 thus allow natural blinking to clear the glands from the softened blockages treated by heat before they solidify again unlike other treatments that require the patient to keep their eyes closed or obstructed during the course of a treatment. and prevent or inhibit the patient from blinking. Heat administration may also increase blood flow promoting vasodilation as increased blood administration may affect metabolism, temperature of other tissues, may have effects or inflammation, and may thus improve tissue function. [083] Because some patients have obstructions or occlusions in their meibomian glands that may not melt, loosen or soften sufficiently without reaching high temperatures in the meibomian glands, treatment strips 10, 12 may apply heat or other treatments to the surface of the eyelids by a significant period of time for relatively longer treatment times and at higher treatment temperatures due to the ability of the treatment strips 10, 12 to remain attached to the patient for any given period throughout the day. Patients can go about their daily activities with their eyes open and eyes blinking and with the comfort of a strip-based treatment. In addition, patients can attach the treatment strips as often as needed throughout the day, week, month, etc. until dry eye symptoms subside. This increases treatment frequency, treatment convenience, and thus treatment effectiveness. [084]Due to prolonged treatment times, application of a separate force in addition to applying the strips may not be necessary as long as the patient is able to continue blinking during the course of treatment. Also, the frequency of treatment can be varied depending on the severity of the condition being treated. An example for potential treatment frequency might include applying one or both strips, for example, up to six times a day for ten minutes or more than an hour or more for each treatment. In addition, because the treatment strips are positioned over the meibomian glands that overlap the ocular surfaces, the application of heating therapy can also indirectly warm the ocular surface, as well as further reduce any chronic ocular surface inflammation, chronic conjunctival inflammation. or corneal neovascularization. [085] In addition to ocular surface heating, heat therapy can also potentially be used to provide indirect heating across the ocular surface, as well as to heat the retina to provide thermal therapy to limit inflammation and neovascularization that are conditions underlying diseases such as age-related macular degeneration (AMD) and Diabetic Retinopathy. [086]While treatment strips 10, 12 can be used throughout the day to take advantage of the patient's physiological blinking, treatment strips 10, 12 can also be used while the patient is resting or sleeping or while the patient is simply keep your eyes closed. [087] The treatment strips 10, 12 are desirably flexible enough to accommodate movement of the upper eyelid UL and/or the lower eyelid LL which can move as much as about 15mm or more. In this way, the treatment strips 10, 12 can be manufactured from different materials. Figs. 3A and 3B show front and cross sectional side views, respectively, of an example of a treatment strip configured to have an adhesive 32 positioned around a periphery of the strip to leave a contact region 30 for direct placement against the skin surface. . The contact region 30 may further include a moisture layer to interface between the strip and the skin to facilitate heat transfer from the strip, as well as provide moisturizing therapy for the skin. Alternatively, the treatment strips can be used with any number of wetting agents that can be applied to the underlying skin by patient P or by a practitioner separately from the treatment strips. In addition, the contact region 30 can be formed to have a surface that is smooth, porous, irregular, corrugated, etc. to facilitate contact and heat transfer from the treatment strip to the skin surface. Alternatively, the entire contact region 30, including its periphery, can be adhesive to maintain good contact. It can be hinged or curved to allow flexion or contraction movement for comfort and physiologically better sound ergonomics. In use, the strip can be applied under tension, as shown by strip 10' in Fig. 3D, to further reduce any impairment to blinking and once adhered to the skin, the strip can be released to allow for flexing, as shown by the strip. released 10” also in Fig. 3D, to facilitate the blinking of the patient P. [088] In this variation, the treatment strip 10 can be configured to have a contact layer 34 (for example, fabricated from conductive materials such as metals, alloys, porous ceramics, engineering ceramics, woods, polymers, composites, foams, polymer foams, fabrics, elastomers, etc.) that can protect the skin from burns or any other adverse effects. A second heating layer 36 can be positioned above the contact layer 34 (or directly in contact with the skin) to generate heat energy and an insulating layer 38 can be positioned above the heating layer 36 to focus, direct, or reflect heat towards the underlying layer of the skin surface as well as protect the patient from contact with the heating layer 36 from other parts of the body. The insulating layer 38 can thus be manufactured from a variety of insulating materials, for example, foams, foam tapes, gauze, silicone, micro-porous polyethylene films, metals, alloys, reflective materials, mirrors, etc. In addition, the thickness of the treatment strip 10 may vary, for example, from about 1/64", 1/8" or more, depending on the mechanism of the heating layer 36, as well as the desired thermal profile and transmission temperature targeted. Additionally and/or alternatively, the insulating layer 38 can be comprised of a thermochromic material that can change its color when a targeted temperature has been reached by the treatment strip 10 to indicate to the patient that the targeted temperature has been reached or when therapy has been finished. [089] Heating layer 36 can be configured to generate its heat energy, for example, up to a temperature range of about 20° to 55° C (or more) or between 40° to 50° C, through any number of diverse mechanisms, such as mechanical, electrical or chemical mechanisms. In a variation, the heating layer 36 can comprise an air-actuated heater that can rise to an elevated treatment temperature for a period of time lasting, for example, from 5 minutes to 24 hours or even longer. An example might include the air-actuated layer incorporating, for example, iron. Other examples may incorporate a heating layer 36 containing, for example, cellulose, iron powder, water, activated carbon (to accelerate the reaction), vermiculite (water reservoir), and salt (catalyst), saw dust, chloride. sodium or water, etc. to generate heat from an exothermic oxidation of iron when exposed to air. Other variations may comprise a heating layer 36 that incorporates light-based activation (visible or powdered UV light) or use of a supersaturated solution (of the crystallization type) to initiate and/or maintain an exothermic reaction. [090] Optionally, in addition to using a thermochromic material to determine when the treatment strip has reached a particular temperature, a separate temperature sensor 39 (eg, thermocouple device or thermistor) can be incorporated on the treatment strip 10, as shown in Fig. 3B, attached to the top of the strip or the bottom of the strip. The treatment strip 10 may also incorporate an optional controller and/or display 37 having a processor which is programmable and which may incorporate a separate on/off feature as shown in Fig. 3C. Temperature sensor 39 may be in communication with controller 37 which may be programmed to regulate the temperature of heating layer 36 and/or a time duration for a particular treatment. Controller 37 may thus be programmable by a physician or caregiver or directly by the patient. Alternatively, controller 37 may be configured to be inaccessible by the patient, but may merely provide temperature and/or time indications for display to the patient. In the event that controller 37 is programmable, controller 37 may be programmed, for example, to set a length of a heating period, set treatment times, set predetermined temperature ranges, control a heating temperature profile (such as such as gradually increasing the heating temperature or decreasing the temperature over a predetermined period of time), etc. [091] In another variation, the heating layer 36 can generate heat through the exothermic crystallization of supersaturated solutions (typically sodium acetate) that are normally reusable. Treatment strips can be recharged by heating them, for example, boiling and allowing them to cool. The heating of these treatment strips can be triggered by snapping a small metal device placed on the treatment strips which generates nucleation centers that initiate crystallization. Heat is needed to dissolve the salt in its own water of crystallization and it is this heat that is released when crystallization starts. [092] In yet another variation, the heating layer 36 may comprise a battery operated heater that uses electrically resistive heating elements that are used to convert electrical energy in the battery to thermal energy. The power supply can be internal or external to the treatment strips and the treatment strips can be charged, for example, by direct electrical contact, induction, etc. [093]Other mechanisms that can be incorporated into heating layer 36 may comprise chemically triggered reactions, such as those used by sodium acetate heating pads. For example, a single single-use chemical reaction using catalyzed iron oxidation or calcium chloride dissolution can be used where the reagents are kept in separate compartments within the treatment strips. When the patient squeezes the treatment strips, the compartments can break and the reagents mix to produce heat. Examples may include the use of a supersaturated solution of sodium acetate (NaCH3COO) in water where crystallization can be triggered by flexing a small flat disc of beveled ferrous metal incorporated into the liquid which act as nucleation sites for the crystallization of sodium acetate in the hydrated salt (sodium acetate trihydrate). Because the liquid is supersaturated, this causes the solution to suddenly crystallize which releases energy from the crystal structure. [094] Yet another example of use in heating layer 36 may include the use of a hot gel containing a supersaturated solution of a salt. Heat can be generated when crystallization of a given salt occurs exothermically. Such heating layer 36 can be reused by forcing the salt back into solution within heating layer 36. [095] Still other examples for incorporation in heating layer 36 may also include the use of highly specific heat-capacity materials that can be heated, for example, by placing a microwave before use, and then allowed to release heat over a specific period of time. [096] Although the application of heat energy from the treatment strips is described, other variations may alternatively include the application of using the treatment strips to cool the underlying skin. Rather than using the heating layer 36 in an exothermic reaction, the layer can be configured to use the endothermic reaction instead to provide cooling to the skin at varying temperatures, for example, from about 0°C to 37°C °C or more particularly from about 25°C to 35°C. An example might include having layer 36 to incorporate salt and ammonium nitrate or ammonium chloride. Mixing water and ammonia can reduce the temperature of layer 36. Another variation can include the use of coolant gel made by adding hydroxyethyl cellulose or vinyl-coated silicone gel that can be cooled or frozen prior to use. Alternatively, cooling can be achieved by applying a cooling element such as a Peltier junction. Cooling, unlike heating, can be applied for conditions such as reducing inflammation, alleviating allergies or tired eyes, etc. particularly as the patient rests or sleeps. An example includes treatment for allergic conjunctivitis where application of cooling treatment can provide relief from any burning or itchy sensations by serving as a vasoconstrictor to limit blood flow, reduce blood vessel leakage and permeability, thus reducing acute swelling and inflammation. Yet another example includes reducing inflammation and fibrosis of a conjunctival bleb resulting from a trabeculectomy or decreasing inflammation usually following any ophthalmic surgical procedure. [097]Given the large number of diverse mechanisms for incorporating a heating layer 36, the treatment strips can be configured to be single-use disposable strips, selectively actuable multi-use disposable reusable strips, etc. [098] In addition to the application of heat energy from the treatment strips, the strips can also include a layer for the diffusion or release of one or more pharmaceutical, biological or chemical agents alone or in combination with heat treatment. For example, pharmaceutical, biological or chemical agents can be incorporated either in contact layer 34, insulating layer 38 or in a completely separate layer, for transdermal administration to the meibomian glands or areas around the meibomian glands for additional treatments and/ or alternatives. For example, examples of some of the various pharmacological agents that can be incorporated into treatment strips (for use with or without heat treatment) may include, but are not limited to, anti-inflammatory compounds, antibiotics, topical tetracycline, oral tetracycline, corticosteroid topical, oral corticosteroid, topical androgens, metronidazole, steroid antagonists, topical androgen analogues, TGF-β, omega 3 or omega 6 compounds, vasoconstrictors such as naphazoline, oxymetazoline, phenylephrine, and tetrahydrozoline, enzymes that promote lipid production, agents that stimulate the production of enzymes that promote the production of lipid, agents that stimulate the production of enzymes that promote the production of lipid, agents that act as secretagogues to increase the secretion of the meibomian gland, agents that replace or promote the production of any component lacrimal, cholinergic, muscarinic or nicotinic agonists may be used, cosmeceuticals such as acid retinol or hyaluronic (HA) for wrinkled, blistered or sagging skin in the cosmetic space, retinoic acid for acne, or agents that degrade or break down lipids such as lipase, etc. [099]Other agents may include, for example, alpha melanocyte stimulating hormone or adrenocorticotropic hormone or androgens such as testosterone to increase tear production, agents that stimulate underlying muscles such as orbicularis or Riolan muscle to stimulate blinking, increase eyelash blink frequency, or maintain longer closure after blinking by inhibiting the levator palpebral muscle to force a blink or eyelid closure, or otherwise mechanically compressing the meibomian glands or Zeis' glands or other goblet cells or accessory tear glands. [0100] Additionally and/or alternatively, other agents for incorporation in the treatment strips may further include, for example, neurotransmitters, noxious or irritating chemicals or vapors, hormones, oils, lipids, polar lipids or fatty acids. The use of neurotransmitters may allow stimulating the occurrence through second messenger pathways such as activation of the Calcium/Protein Kinase C pathways, G protein activation, other pathways related to calcium, calcium-calmodulin dependent protein kinases, the calcium-dependent pathways cyclic adenosine monophosphate, adenylyl cyclase pathways, cAMP-dependent inhibition of phosphodiesterases. [0101] In the event that the pharmaceutical or chemical agent is released during heat treatment, heat can help improve the penetration of any drugs into the underlying skin. [0102] Yet another variation may incorporate a treatment strip that applies a frictional heat that can be applied through the treatment strips onto the upper UL and/or lower LL eyelids for the treatment of the meibomian glands or that applies a compound that attracts light and heats this way. Each of these variations can allow treatment strips 10, 12 to be applied and used while allowing natural blinking to occur to facilitate cleaning of the ducts of molten oil blockages within the meibomian glands and to facilitate the dispersal of oil in tears. [0103] While treatment strips can incorporate several layers into the strips to effect several different treatments, the strips can also be varied in size, shape, contour etc. depending on the desired treatment areas as long as the treatment strips are delineated or shaped to follow the location of at least one meibomian gland. An example of another configuration for the treatment strips is shown in the front view of Fig. 4, which illustrates an outlined tapered strip 40 sized and shaped for placement across the upper eyelid UL. This treatment strip may have a delineated lower edge 42 as well as an delineated upper edge 44 that follows the placement of the underlying meibomian glands. In addition, although strips 40 are shown placed over the UL upper eyelids of both eyes of patient P, a single strip 40 can be used over a single eyelid to selectively treat the meibomian glands in this and other examples shown here. Additionally, one or both of the UL upper eyelids may be treated alone or in combination with one or both of the LL lower eyelids depending on the treatment desired in this and other examples shown here. [0104] Another variation is shown in the front view of Fig. 5 which shows an outlined thickened strip 50 having an outlined lower edge 52 and an outlined upper edge 54 for placement over the meibomian glands as well as surrounding tissue and glands. In still other variations, rather than using two separate treatment strips, a single strip can also be used that extends over the bridge of the patient's nose. Additionally, the thickened strip 50 can cover the parts of the skin furthest away from the edge of the eyelid to facilitate treatment. Because the arterial blood supply to the eyelids runs from proximal to distal from the lid margins, the treatment strip may heat (or cool) the blood supply as it continues to flow toward the lid margins. This early warming (or cooling) can provide a therapeutic effect for increased patient comfort, less impact on eyelid function (such as blinking), and increased safety of application and distance from the ocular surface, as well as potentially increased efficacy allowing for therapy. more total heating or cooling. [0105] Fig. 6 shows yet another variation having a tapered delineated strip 60 in which the lower edge 62 and the upper edge 64 converge to a tapered end 66 for placement over the meibomian glands. Fig. 7 shows yet another variation in which the treatment strips may comprise straight strips 70 having a first width used in combination with a tapered straight strip 72. The straight strips 70 may comprise straight strips (having optionally rounded corners) which may be selectively placed over the meibomian glands. In this example, a single straight strip 70 can be applied over the upper eyelid UL of a single eye while the other eye can use a single straight strip 70 applied to a first portion of the upper eyelid UL and a second straight strip 72 having a relatively wide width. thinner for placement over a second part of the UL upper eyelid. Each of the strips can be applied singly or in various combinations depending on the desired treatment areas and are shown in this variation as an exemplary combination. [0106] In the variation of Fig. 8, an example of the thin delineated strip 80 applied across the lower eyelid LL is shown. As illustrated, the delineated upper edge 82 and delineated lower edge 84 can be delineated to flow over the underlying meibomian glands. As described above, the treatment strips can be applied singly over one or both eyes or can be applied in combination with the treatment strips over one or both eyes of the upper eyelids. In addition, any of the treatment strips shown here can be used in any number of combinations with each other. [0107] Fig. 9 shows another variation in which the outlined thickened strip 90 can be applied over the lower eyelids LL and can still have a width that is relatively wider than those treatment strips shown above in Fig. 8. Similarly, Fig. 10 shows yet another variation in which the outlined thickened strip 92 can have a width that is relatively wider still to treat not only the underlying meibomian glands, but also any glands and tissue around the periorbital region. As described above for the variation of Fig. 5, the extended treatment strip can heat (or cool) the energy supply as it continues to flow toward the lid margins. Early warming (or cooling) can provide a therapeutic effect for increased patient comfort, less impact on eyelid function (such as blinking), and increased safety of application and distance from the ocular surface. [0108] In addition to variations in the width of the treatment strips, any treatment strips can be varied in length, as well as selectively target parts of the meibomian glands or particularly selected meibomian glands. For example, Fig. 11 shows a variation in which the shortened outlined strip 100 having a shortened first length can be applied over the lower eyelid LL (and/or over the upper eyelid UL). A second delineated strip 102 having a second length that is greater than the shortened delineated strip 100 can also be seen for comparison. Fig. 12 similarly shows a shortened straight strip 100 applied over the lower eyelid LL and a second straight strip 112 having a relatively greater length applied over the lower eyelid LL. Straight strips 110, 112 may incorporate rounded ends and may be varied in length depending on the desired treatment area. They can also be rounded or circular to cover one or more styes. [0109] Fig. 13 shows yet another variation in which the outlined strips 120 can be configured to have tapered ends to overlap the meibomian glands. In comparison, the thickened outlined strip 122 is also illustrated having tapered ends that are still relatively wider to alter the treatment area. [0110] Fig. 14 shows another variation in which the delineated strip 130 may have a first part 132 that is relatively wider than a second part 134 for placement over the meibomian glands of the lower eyelid LL. Each of the first 132 and second part 134 can be varied in width again depending on the desired treatment areas. Another example is shown in Fig. 15 which shows an outlined strip 140 having a first part 142 and second part 144 that are considerably wider to treat not only the meibomian glands along the lower eyelid LL, but also surrounding the periorbital tissue regions. , such as the underlying maxillary bell. Fig. 16 shows yet another example of an outlined strip 150 having a first part 152 and a second part 154 that is wider than the first part 152 and where the strip 150 is positioned to cover only a part of the meibomian glands along the length. lower eyelid LL, but also covers several other glands, such as the lacrimal glands, around the periorbital regions. [0111] Fig. 17 shows yet another variation of a treatment strip comprised of an outlined strip 160 having an enlarged secondary part 162 connected through a connector strip 164. While the outlined strip 160 can treat the meibomian glands along the eyelid LL, the secondary augmented portion 162 can treat the tissue region along the patient's cheeks. [0112] In yet another variation, Fig. 18 shows an example where an upper delineated strip 170 and a lower delineated strip 172 can be applied, respectively, along the upper eyelid UL and the lower eyelid LL. As discussed above, the outlined strips 170, 172 are shaped and applied to follow the underlying meibomian glands while allowing patient P to blink normally. Fig. 19 shows a similarly applied delineated strip 180 and lower delineated log 182 where the strips can be varied in color to more closely match a patient P's skin tone or shading. for any given period of time, strips 180, 182 can be made in several colors or shades to both closely match the tone or color of the patient's skin P. [0113] In yet another variation, Fig. 20 shows another example where the treatment strips can be varied in length to treat specific regions along the upper UL or lower LL eyelids. In this example, a first top strip 190 having a first length may be applied adjacent to a second top strip 192 having a second longer length. Optionally, a third top strip 194 and/or fourth top strip 196 having lengths that are relatively shorter can also be applied, as well as over selected meibomian glands. A lower strap 198 having enlarged distal ends 200, 202 is also shown for placement across the lower eyelid LL. The distal ends 200 can be shaped to facilitate placement and/or removal of the strip 198 from the skin (or for better adhesion). Yet another example is shown in Fig. 21 illustrating a plurality of shortened treatment strips, for example, a first upper strip 210 and a second upper strip 212, selectively placed along the upper eyelid UL together, for example, with the first lower strip 214 and the second lower strip 216, selectively placed along the lower eyelid LL. Each of the strips can be varied in length as well as size depending on the treatment area. [0114] While the lengths of the treatment strips are variable, multiple strips can be applied adjacent to each other to overlap horizontally and/or vertically across the eyelids. Furthermore, one or more of the treatment strips can be made as a single unit or as a series of horizontally or vertically oriented panels that can be optionally connected by a back that is flexible. As shown in the variation of Fig. 22, each of the whitened strips 220 may have a length, for example, of about 1 m, to cover as much as a single meibomian gland. One or more of the bleached strips 220 may be applied across the upper eyelid UL and/or lower eyelid LL. Additionally, one or more of the target strips 222 may further comprise a connector member 224 which functions as a back to couple each of the individual target strips 222 together. The individual strips can be selectively applied to particularly problematic meibomian glands or along the upper eyelid UL and/or lower eyelid LL. For example, Fig. 23 illustrates the individual target strips 222 placed along the lower eyelid LL. [0115] While treatment strips can be applied to one or more of the meibomian glands, variations of the strip can also be used to treat other glands, such as sebaceous glands, eg acne treatment. The treatment strips used to treat acne can use different pharmacological treatments. Other glands in the underlying eyelids and CN conjunctiva for treatment may also include treatment, eg Zeis GZ accessory glands, sebaceous accessory glands, accessory goblet cells such as Henle and Manz glands, Wolfring GW or Krause GK accessory lacrimal glands , or one or both lobes of the main lacrimal glands, such as the eyelid or the orbital part. [0116] In addition, treatment strips can be used to potentially treat eye disorders in addition to meibomian gland dysfunction including, for example, blepharitis, Sjogren's syndrome, dacryoadenitis, conjunctivitis, allergic conjunctivitis, keratoconjunctivitis sicca, keratitis, dacryocystitis, iritis, keratitis, retinitis, sclerokeratitis, uveitis, eye problems related to contact lens, post blepharoplasty, or eyelid or ocular surgical procedures (eg, cataract surgery, LASIK, PRK, etc.), dysfunctional blinking disorders or absenteeism, conjunctivitis, blepharospasm, exposed keratopathy, lagophthalmia, eyelid myochemia, infections, styes, chalazion, hordeolum, glaucoma, blisters, trauma, etc. [0117] Yet another example, as mentioned above, may include the use of treatment strips to treat disorders of the LG tear gland and/or eyelid tear gland that are located above the eye as shown in Fig. 24. Variously sized treatment strips , like the tear gland strips 230 shown in Fig. 25 which are sized to have a curved upper periphery, can be sized for placement directly on the skin surface above where the LG tear glands are located. Other variations are shown in Fig. 26 which illustrates tear gland strips 232 which are relatively thinner in width, as well as in Fig. 27 which illustrates tear gland strips 234 which have curved peripheries ending in tapered ends. The treatment strips can administer heat, for example, to stimulate the LG tear gland, increase the gland's metabolism, activity and tearing, etc. Alternatively, treatment strips can administer cooling therapy to reduce inflammation that impedes gland function. [0118] The lacrimal glands LG and/or the lacrimal gland PL can be treated alone or in combination with the treatment strips designed for treating the meibomian glands. A variation is shown in Fig. 28 which illustrates delineated strips 240 that are increased in width to cover both LG tear tears as well as the meibomian glands along the upper eyelid UL. Outlined treatment strips 242 are also shown placed along the lower eyelids LL for treatment of the meibomian glands. [0119] Fig. 29 shows another variation in which the tear gland strips 250 can be placed over the LG tear glands in combination with an integral combined delineated strip 252 that is sized to enclose the eyes completely while following the location of the meibomian glands along both the upper UL eyelids and the lower LL eyelids. This completely surrounding design can also be held in place more tightly against the skin with a strap that can wrap around the patient's head if desired. Another variation is shown in Fig. 30 which illustrates an integral combined delineated strip 260 that is also sized to completely enclose the eyes and still have a suitable width for placement over the LG tear glands. [0120] The Lacrimal Gland Strip 270 can be used in combination with any of the treatment strips shown here. Another example is illustrated in Fig. 31 which shows the tear gland strip 270 used in combination with the individual strips 222 while Fig. 32 shows yet another example where the tear gland strip 270 can be used in combination with not only the individual strips 222, but also strips 220 located along the respective LL eyelid and UL upper eyelid. [0121] While treatment strips can be applied over the meibomian glands to apply heat energy, the treatment does not require the application of any external force applied by the strip or any other external device, but can utilize the patient's natural blinking to facilitate treatment as described above. However, in additional variations, the treatment strips can be configured to apply both heat treatment as well as an external force. Any number of mechanisms can be used to apply a compressive or polarizing force to provide compression of the underlying skin of the meibomian glands during the application of heat therapy. An example is shown in the front view of Fig. 33 which illustrates a polarized treatment strip 280 that may be comprised of a strip 282, as described above, having one or more bias mechanisms 284 positioned along the strip 282. more bias mechanisms 284 can be positioned along either the top strip or the bottom strip or both, as shown. [0122] In this example, the polarization mechanism 284 can locally pinch or compress the underlying skin to apply pressure to the MG meibomian glands to facilitate clearing any obstructions, particularly if simultaneously applied with the heat treatment. An example of a bias mechanism 284 is illustrated in the perspective view of Fig. 34 which shows how the bias mechanism 284 may generally comprise portions of strip 282 or separate members biased to form corresponding channels 286 that are configured to flex in an open configuration. or closed. When the strip is initially placed on the skin, the ends of the strip can be pulled to open channels 286 which can then be placed on the surface of the skin. As the strip and polarization mechanisms 284 relax, the underlying skin and the MG meibomian glands can be compressed or pressed through compression forces 288 induced in the polarization mechanism 284. [0123] In addition to a compressive force, the strip can be formed with alternative components such as a mechanical component to transmit vibrational energy to facilitate the expression of the meibomian glands and promote oil secretion. An example is illustrated in Fig. 35 which shows another variation of the outlined strip 290A, 290B having one or more vibrating elements 292 (e.g. piezoelectric transducers, electromagnetic actuators, eccentrically coupled rotating elements, etc.) incorporated along the strips 290A, 290B. The one or more vibrating elements 292 may be electrically coupled to a power supply and/or processor 294 also contained along strips 290A, 290B. Furthermore, vibrational energy can be transmitted separately from heat treatment or in combination with heat therapy. The power supply may include a micro-battery that can be rechargeable to manage micro currents of energy. [0124] In addition to the application of mechanical pressure or vibrational energy, other forms of energy can also be administered by one or more treatment strips. Another variation is illustrated in Fig. 36 which shows an upper delineated strip 300A having a conductive element 302 such as a wire integrated along the entire length (or a partial length) of delineated strip 300A. Conductor element 302 may be configured in an alternate pattern or may simply be aligned along the length of the strip as shown by conductive (or electrically resistant) element 306 along lower delineated strip 300B. Each of the conductive elements 302, 306 may be in electrical communication with a respective power supply and/or processor 304, 308. The conductive elements 302, 306 may be selectively actuated to apply heat energy or may be configured to apply energy of radiofrequency (RF) the underlying skin and meibomian glands. With respect to the application of electrical energy, a form of electrical energy applicable through the treatment strips may include the use of a transcutaneous nerve electrical stimulus feature, for example, to deliver neural stimulus to increase tear production. Conductive elements can generate thermal energy through various energy sources, eg battery, solar cell, kinetic motion, RF, etc. [0125] Fig. 37 shows yet another variation in which the outlined strips 310A, 310B can be configured to incorporate an electrode or antenna 312 coupled to a power supply and/or processor 314 for application, for example, of micro power -wave to the underlying meibomian glands. In addition to electrical or microwave energy, the treatment strips can be configured to apply yet other forms of energy to treat the meibomian glands. For example, other variations may incorporate drivers or transmitters for ultrasonic, RF, magnetic microwave, photonics (light energy in the visible or infrared light spectrum) etc. application. In still other variations, the conductive elements can be configured to function as electromagnetic elements once actuated, or the strips can incorporate ferromagnetic elements to promote eyelid closure. Magnetic force could serve to tighten the meibomian glands and expel the oily obstruction as the eyes are opened and reopened by overcoming the magnetic force. [0126] In yet another variation, one or both of the strips 320A, 320B can be configured to incorporate an indicator 324, for example, LED light, alarm, vibrating element, etc., electrically coupled to a power supply and/ or 322 processor to alert the patient when a prescribed treatment has been completed. This feature (and any of the other features) can be combined with any of the other variations of the treatment strips described here as practicable. [0127] Fig. 39 shows yet another variation in which the eyelid treatment system 330 can be formed in a double coupled strip design, for example a wishbone design, where the double strip heating strips can have two heating elements that follow the location of the meibomian glands, the upper UL and lower LL eyelid of a single eye. Depending on whether both eyes or a single eye and/or both upper and lower eyelids are treated, system 330 may comprise a first heating strip assembly 332 and a second heating strip assembly 334 for each respective eye. Each of the sets 332, 334 can thus utilize an upper and lower lid treatment heater, e.g., upper lid treatment strip 332A and lower lid treatment strip 332B, wherein each of the upper and lower elements can be coupled to the other via wires 336. In addition, each of assemblies 332, 334 can be coupled via a connector cable 338 to the attachable controller 340 (e.g., via an input/output port such as a headset, USB port, or other connection port) to a portable electronic device 342 (eg, smartphone having a touchscreen interface, tablet, PDA, laptop computer, etc.) as shown. [0128] In other variations, the number of connecting cables can range from 1-4 connecting cables rather than using a single 338 cable. For example, one cable can be used to provide power and communication for some or all of the heating elements of assemblies 332, 334. Alternatively, four connector cables may provide power and communication for each of the heating elements in assemblies 332, 334. In still other alternatives, two connector cables may provide power and communication for each of assemblies 332, 334 . [0129] In other additional variations, any of the treatment strips may be used in combination with the 342 controller described here, as practicable. In yet another variation, oval or circular heating elements can cover the eye and both eyelids where an outer edge of the heating elements or straps can follow the path of the upper and lower meibomian glands. In this case, one treatment strip can cover both eyelids and both sets of meibomian glands and the user can use a total of two (more than four) round, circular or oval treatment strips to cover both eyes. Such variation can be used, for example, by night therapy in bed before or during sleep when the eyes do not necessarily need to be open. [0130] Sets 332, 334 can generally comprise strips, as previously described, that track the location of the meibomian glands while still allowing patients to blink and comfortably carry on with daily activity. An example of such heaters that can be configured for use with the treatment system 330 can include flexible thin heaters that are commercially available from companies such as Minco Products, Inc (Minneapolis, MN) or can be custom designed and manufactured independently or through third-party manufacturing. Each individual treatment strip, eg treatment strips 332A, 332B may each be dimensioned by a single eyelid, eg 28mm x 7mm x 0.15mm, having a bottom length of eg 28mm , with a radius of curvature of, for example, 75 mm, and having a general configuration of an arcuate rectangle having attenuated corners where the nasal or temporal edges may coincide with the radius of the arc. However, these size limitations are intended to be exemplary and not limited as treatment strips 332A, 332B can be sized to be smaller or larger to accommodate different ocular anatomies. [0131] Furthermore, the individual treatment strips 332A, 332B can be formed as thin flexible transparent polymers containing the heating elements while the contact surface of the strips can be fixed to the respective eyelids with, for example, a disposable adhesive. Other variations may use opaque or colored stripes, eg flesh tone colors. In addition, one or more temperature sensors can also be integrated into the treatment strips where the heating elements and sensor can be guided through the connector cable 338 to a power source and/or controller 340 and/or portable electronic device 342, as shown. [0132] The controller may generally comprise a platform or hardware/software unit may be programmed to control therapy treatments. In this way, controller 340 may include a processor, as well as a power supply such as a battery (rechargeable or disposable) to provide power to assemblies 332, 334. The power supply within controller 340 may optionally be rechargeable separate from the portable electronic device 342 or the power supply can draw power to assemblies 332, 334 and the processor directly from the portable electronic device 342 . [0133] In the case where the controller 340 is programmed to provide the therapy treatment protocols, one or several controls to control the treatments can be built directly into the controller 340. The portable electronic device 342 can interface with the controller 340 to display, in a variation, part of the controls on a screen (eg, touch screen) of electronic device 342 such as controls for starting and/or stopping a treatment. Alternatively, all controls can reside on controller 340 while a display on electronic device 342 can primarily serve to show or track various treatment results or parameters. [0134] In yet another alternative, all controls can reside on the display of electronic device 342 to control the various treatment options and parameters instead of controller 340. In this variation, electronic device 342, in this example, a smartphone can also provide power to the treatment strip assemblies 332, 334 and can also control the various temperatures and treatment times, as well as provide temperature feedback or other physiological parameters that can be measured. In this case, the treatment strips 332, 334 and pluggable cables 338 can be plugged directly into the portable or mobile consumer electronic device 342. For example, the electronic device 342 can be used to display treatment parameters and controls, such as an icon or button to start therapy. In one example, therapy may be initiated by the user via electronic device 342 to heat one or more of the strips of one or both sets of treatment strip 332, 334. In either variation, electronic device 342, particularly in in the case of a smartphone or tablet, it may have an optional program or downloadable application on the device that facilitates the various control and/or display parameters on the 342 electronic device depending on how the 342 electronic device is used with the 340 controller and the 332 sets, 334. [0135] Additionally, electronic device 342 may also provide a diagnostic function to allow the user to test for dry eye and/or to determine how treatment is progressing either before, during or after treatment. In this way, the electronic device 342 or controller 340 can influence, for example, an integrated camera and/or light source/flash, for purposes of obtaining an image of the user's ocular tear film or ocular surface and evaluating commonly used evaluation criteria. used, such as total tear film layer thickness, and/or aqueous tear film layer thickness, or any combination thereof. In addition to obtaining tear film imaging and/or user ocular surface conditions, the mobile application may include other common methods for diagnosing dry eye, such as user questionnaires related to user patient symptoms, discomfort and/or improvement or worsening of symptoms that can be completed using the device's touchscreen interface, results stored on the 342 electronic device or the manufacturer's web application or servers, monitored over time for trend assessment, and possibly shared with the physician of user. [0136] In addition, in any of the variations, the controller 340 and/or electronic device 342 can be programmed or started to heat sets 332, 334 to, for example, 42.5°C +/- 1° to 2 ° C. The treatment time can be set to, for example, 15 to 30 minutes, and the controller 340 and/or electronic device 342 can still be programmed to turn off when the set treatment time has elapsed or if the measured temperature has passed. raise above a predetermined level, eg 45°C. Additionally, the controller 340 and/or electronic device 342 can also be programmed or set to indicate various treatment parameters (eg initiation of treatment, heating of the heating elements warm-ups, treatment termination, errors, battery life, etc.) via any number of visual, auditory or haptic indicators. [0137] Additionally, the controller 340 and/or electronic device 342 can be used to store and/or transmit various data such as historical treatment data, usage time, total treatment time, temperature data, etc. In addition, the controller 340 and/or electronic device can wirelessly communicate with a remote server or additional controller, allowing the controller and/or electronic device 342 to also be programmed remotely, for example, by a physician or other party. . In still other variations, audio and/or visual information (eg, advertisements or other media) may also be displayed on the controller 340 and/or electronic device 342 which may be received from remote servers or various other data may transmitted to and/or from controller 340 and/or electronic device 342. [0138] In still other variations, although controller 340 is illustrated as being coupled to assemblies 332, 334 via a wired connection cable 338, other variations may have controller 340 wirelessly connected to assemblies 332, 334. Such a connection can be via any number of wireless protocols such as Bluetooth®, RF, etc. [0139] This "precise temperature control" mobile heating system can be used to heat other parts of the body as well, where the system remains almost the same, but the dimensions of the heating element can be varied and the power requirements as well. can be changed depending on the total surface area being treated and temperature goals. [0140] With the incorporation of a processor in the treatment strips, treatment times and other parameters such as the temperature of the strips can be programmed and optionally turned on and off selectively by the patient or automatically. In addition, other parameters such as the frequency of heat administration or other stimulus can also be programmed by the processor to provide greater flexibility in treatment. [0141] The applications of the devices and methods discussed above are not limited to the treatment of dry eye syndrome, but also include any number of other treatment applications. Additionally, such devices and methods can be applied to other locations within the body where acute or chronic inflammation causes a disease or condition. Treatment strips can thus be custom-engineered to follow the path of the underlying physiology, for example, heating or cooling treatment strips designed and custom-engineered to treat sinusitis and acute or chronic sinusitis, respectively, rhinitis and allergic rhinitis, joint pain and inflammation, arthritis, muscle pain, back pain, headaches, sports injuries, etc. Modification of the kits described above and methods for carrying out the invention, combinations between different variations as practicable, and variations of aspects of the invention that are obvious to those skilled in the art are intended to be within the scope of the claims.
权利要求:
Claims (40) [0001] 1. WARMING ASSEMBLY, characterized in that it comprises: an upper strap (10, 170, 180, 300A, 310A, 320A, 332A) configured to adhere to a skin region of the upper eyelid (UL) of an individual, the upper strap being configured to have the contour size and flexibility to allow the individual to blink naturally without restriction of the upper strap, wherein the upper strap has an upper curved periphery (14) that is configured to extend and follow an upper edge of the meibomian glands of the upper eyelid and a lower periphery (16) that is configured to extend and follow a free margin of the upper eyelid such that an outer edge of the upper strip is contained by an underlying tarsal plate; and a lower strap (12, 172, 182, 300B, 310B, 320B, 332B) configured to adhere to a skin region of a lower eyelid (LL) of the subject, wherein the lower strap has an upper periphery (20) that is configured to extend and follow a free lower lid margin and a lower curved periphery (18) that is shaped to extend and follow a lower edge of one or more meibomian glands of the lower lid, such that an outer boundary. of the lower strip is constrained by an underlying tarsal plate, wherein each of the upper and lower strips comprises a heating layer or a cooling layer (36) configured to be in thermal communication with the respective regions of the skin and configured to emit energy to the skin region. [0002] 2. ASSEMBLY according to claim 1, characterized in that each of the upper and lower strips comprise a contact surface for placement against the skin region. [0003] 3. ASSEMBLY according to claim 1, characterized in that it further comprises a thermochromic layer in thermal communication with the heating layer. [0004] 4. ASSEMBLY according to claim 1, characterized in that the heating layer is configured to generate heat in a temperature range from 20°C to 55°C. [0005] 5. ASSEMBLY according to claim 1, characterized in that the heating layer is configured to generate heat for a period of time from 5 minutes to 24 hours. [0006] 6. ASSEMBLY, according to claim 1, characterized in that the cooling layer is configured to reduce in temperature over a range from 0°C to 37°C. [0007] 7. ASSEMBLY, according to claim 1, characterized in that the cooling layer comprises a hydrogel layer. [0008] ASSEMBLY according to claim 1, characterized in that one or more strips comprise an insulating layer (38). [0009] 9. ASSEMBLY according to claim 1, characterized in that each of the strips has a length ranging from 1 mm to 50 mm. [0010] 10. ASSEMBLY according to claim 1, characterized in that each of the strips has a width ranging from 1 mm to 25 mm. [0011] ASSEMBLY according to claim 1, characterized in that it further comprises a controller (340) connected to the upper and lower straps. [0012] 12. ASSEMBLY according to claim 11, characterized in that the controller is programmed to control one or more parameters of the upper and lower strips. [0013] ASSEMBLY according to claim 12, characterized in that one or more parameters comprise a temperature, time, frequency, or thermal profile of the upper and lower strips. [0014] The ASSEMBLY of claim 1, further comprising one or more additional strips configured to adhere to a second region of skin in proximity to a lacrimal gland of the subject. [0015] 15. ASSEMBLY according to claim 1, further comprising one or more biasing mechanisms (284) positioned along the upper and lower strips, wherein the one or more biasing mechanisms are configured to apply pressure to the region. of the skin. [0016] 16. ASSEMBLY according to claim 1, characterized in that it further comprises one or more actuators positioned along the upper and lower strips. [0017] 17. ASSEMBLY according to claim 1, characterized in that it further comprises an electrically conductive element (302, 306) positioned along the upper and lower strips. [0018] 18. ASSEMBLY, according to claim 17, characterized in that the electrically conductive element is an electrode. [0019] 19. ASSEMBLY according to claim 17, characterized in that the electrically conductive element comprises a microwave antenna. [0020] 20. ASSEMBLY according to claim 1, characterized in that it further comprises an indicator (324) positioned along the upper and lower strips. [0021] 21. ASSEMBLY, according to claim 20, characterized in that the indicator comprises an audible or visual alarm to alert the individual. [0022] 22. ASSEMBLY according to claim 1, further comprising one or more pharmaceutical agents infused into or along the upper and lower strips. [0023] 23. ASSEMBLY according to claim 1, characterized in that it further comprises a power supply positioned along the upper and lower strips. [0024] 24. ASSEMBLY according to claim 23, characterized in that the power supply is rechargeable. [0025] 25. ASSEMBLY according to claim 1, characterized in that the upper curved periphery is arcuate. [0026] 26. ASSEMBLY according to claim 1, characterized in that the lower curved periphery is arcuate. [0027] 27. ASSEMBLY, according to claim 17, characterized in that the electrically conductive element is a resistive element. [0028] 28. ASSEMBLY according to claim 1, further comprising one or more biological agents infused into or along the upper and lower strips. [0029] 29. ASSEMBLY according to claim 1, characterized in that it further comprises one or more chemical agents infused into or along the upper and lower strips. [0030] 30. HEATING SYSTEM, characterized in that it comprises: an upper strap (10, 170, 180, 300A, 310A, 320A, 332A) configured to adhere to a skin region of the upper eyelid (UL) of an individual, the upper strap being configured to have the contour size and flexibility to allow the individual to blink naturally without restriction of the upper strap, wherein the upper strap has an upper curved periphery (14) that is configured to extend and follow an upper edge of the meibomian glands of the upper eyelid and a lower periphery (16) that is configured to extend and follow a free margin of the upper eyelid such that an outer edge of the upper strip is contained by an underlying tarsal plate; and a lower strap (12, 172, 182, 300B, 310B, 320B, 332B) configured to adhere to a skin region of a lower eyelid (LL) of the subject, wherein the lower strap has an upper periphery (20) that is configured to extend and follow a free lower lid margin and a lower curved periphery (18) that is shaped to extend and follow a lower edge of one or more meibomian glands of the lower lid, such that an outer boundary. of the lower strip is constrained by an underlying tarsal plate, and a controller (340) in communication with upper and lower strips, the controller being programmable for thermal energy emission, wherein each of the upper and lower strips comprises a heating layer ( 36) configured to be in thermal communication with the respective skin regions and configured to emit thermal energy to the skin region. [0031] 31. SYSTEM according to claim 30, characterized in that each of the upper and lower strips comprise a contact surface for placement against the skin region. [0032] 32. SYSTEM according to claim 30, characterized in that it further comprises a thermochromic layer in thermal communication with the heating layer. [0033] 33. SYSTEM according to claim 30, characterized in that the controller is coupled to the upper and lower straps through a connector cable (338). [0034] 34. SYSTEM according to claim 30, characterized in that the controller is programmed to control one or more parameters of the upper and lower strips. [0035] A SYSTEM according to claim 34, characterized in that one or more parameters comprise a temperature, time, frequency or thermal profile of the upper and lower strips. [0036] 36. SYSTEM according to claim 30, characterized in that it further comprises a portable electronic device (342) detachably coupled to the controller. [0037] 37. SYSTEM according to claim 36, characterized in that the portable electronic device comprises a smartphone or tablet. [0038] 38. SYSTEM according to claim 37, characterized in that the smartphone is programmed to provide an audible, visual or haptic indicator for communication with the user. [0039] 39. SYSTEM according to claim 30, characterized in that the upper curved periphery is arcuate. [0040] 40. SYSTEM according to claim 30, characterized in that the lower curved periphery is arcuate.
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同族专利:
公开号 | 公开日 CN104334129A|2015-02-04| JP2019034176A|2019-03-07| JP6768761B2|2020-10-14| CN104334129B|2017-09-19| US20170165106A1|2017-06-15| US9642743B2|2017-05-09| CN107510545A|2017-12-26| US20170079834A1|2017-03-23| BR112014016505B8|2021-06-01| US20180344512A1|2018-12-06| US9510972B2|2016-12-06| JP2020199386A|2020-12-17| BR112014016505A8|2017-07-04| BR112014016505A2|2017-06-13| EP2800543B1|2019-06-26| ES2739630T3|2020-02-03| EP2800543A4|2015-11-11| JP2015503417A|2015-02-02| US10052226B2|2018-08-21| US20210177647A1|2021-06-17| US9844459B2|2017-12-19| US10925765B2|2021-02-23| JP6747770B2|2020-08-26| WO2013103413A1|2013-07-11| EP2800543A1|2014-11-12| US20130172829A1|2013-07-04| US20170079840A1|2017-03-23|
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法律状态:
2018-12-11| B06F| Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]| 2019-11-05| B06U| Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]| 2020-10-20| B06A| Notification to applicant to reply to the report for non-patentability or inadequacy of the application [chapter 6.1 patent gazette]| 2021-03-23| B09A| Decision: intention to grant [chapter 9.1 patent gazette]| 2021-05-18| B16A| Patent or certificate of addition of invention granted|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 09/10/2012, OBSERVADAS AS CONDICOES LEGAIS. | 2021-06-01| B16C| Correction of notification of the grant|Free format text: REFERENTE AO DESPACHO 16.1 PUBLICADO NA RPI 2628, QUANTO AO ENDERECO DO TITULAR |
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申请号 | 申请日 | 专利标题 US13/343,407|2012-01-04| US13/343,407|US9724230B2|2012-01-04|2012-01-04|Dry eye treatment apparatus and methods| US13/645,985|2012-10-05| US13/645,985|US9510972B2|2012-01-04|2012-10-05|Dry eye treatment systems| PCT/US2012/059384|WO2013103413A1|2012-01-04|2012-10-09|Dry eye treatment systems| 相关专利
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