Dry eye treatment system

Abstract

To provide a method and a device for treatment of a dry eye syndrome and other related symptoms.SOLUTION: Strips 10 and 12 for treatment attached to the skin of the upper eyelid UL and / or the lower eyelid LL include one or more strips 10 and 12 configured so as to come in contact with a lower layer region of the skin adjacent to one object eye or two object eyes so that the one or more strips 10 and 12 enable the objects to blink naturally without any restrictions from one or more patches. The one or more strips 10 and 12 may be configured so as to discharge energy in the lower layer region of the skin. The one or more strips 10 and 12 follow the place of one or more meibomian glands included in the lower layer region of the skin.SELECTED DRAWING: Figure 2A

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This is a continuation-in-part of U.S. patent application Ser. No. 13 / 343,407, filed Jan. 4, 2012, and a continuation of U.S. patent application Ser. No. 13 / 645,985, filed Oct. 5, 2012, the contents of which are incorporated by reference herein in their entireties.

[0002] The present invention relates to methods and devices for the treatment of dry eye syndrome and other related conditions. More particularly, the present invention relates to methods and devices for the treatment of dry eye syndrome using adhesive strips that are specifically contoured or shaped to adhere to selected areas around a patient's eye or periorbital area. [Background technology]

[0003] Tears are a complex mixture of water, lipids, mucus, proteins, and electrolytes that help maintain a smooth and clear optical surface and also help protect the eye from infection. The tear film has three basic layers: oil, water, and mucus, and problems or disorders in any of these layers can result in dry eye symptoms.

[0004] The outermost layer of the tear film typically consists of an oily layer containing fatty acids and lipids (meibum) produced primarily by sebaceous glands, called meibomian glands, located along the eyelid margin. The oily layer smoothes the tear surface and slows down the evaporation of the aqueous middle layer. However, if the meibomian glands cannot produce enough oil, produce a suboptimal fatty acid mixture, or the glands are blocked or clogged, the aqueous layer typically evaporates quickly, resulting in dry eye. Blockage of the meibomian glands can lead to enlarged glands or infection. Dry eye is therefore common in people whose meibomian glands are blocked or functioning improperly.

[0005] The central layer of the tear film consists primarily of an aqueous solution produced by the lacrimal (lacrimal) gland. The central layer cleanses the eye, washing away foreign particles or irritants, maintaining a clear optical medium, and keeping the ocular surface moist. The innermost layer of the tear film consists primarily of mucus, which helps to spread the tear fluid evenly across the ocular surface. A lack of mucus in the tear film is also associated with dry eye syndrome.

[0006] As previously mentioned, meibomian glands are oil-secreting glands located in both the upper and lower eyelids. There are approximately 30-40 glands along the upper eyelid and 20-30 glands along the lower eyelid, with ducts for each of the glands opening along the inner edge of the free edge of each individual eyelid near minute holes through which the secretions are released to prevent the eyelids from adhering to each other. An example of the location of the meibomian glands illustrates the relative positioning of a single meibomian gland MG. The meibomian glands MG are illustrated in the cross-sectional view of the upper eyelid UL shown in Figure 1A. Other glands and anatomical features are also illustrated for reference, such as Wolfring's gland GW, tarsal plate TR, Moll's gland GM, Zeiss's gland GZ, Krause's gland GK, superior fornix UF, conjunctiva CN, and the cornea CR of the eye, which is partially covered by the upper eyelid UL. As illustrated, the meibomian glands MG are located along the length of the upper eyelid UL (and lower eyelid LL), with ductal openings along the medial edge of the eyelid UL, proximate to the underlying ocular surface.

[0007] FIG 1B illustrates a front view of a patient's eye with the upper eyelid UL and lower eyelid LL in a closed position, such as when the patient blinks. As shown, the meibomian glands MG can be seen aligned adjacent to one another across both the upper UL and lower eyelid LL. FIG 1C also illustrates how the meibomian glands are typically aligned relative to one another when the patient's eye is open. FIG. 1 shows a perspective view of a patient's eye in an open position illustrating how the ophthalmic

[0008] Blinking is believed to be the primary mechanism for opening the pores of the meibomian glands and allowing the release of oily secretions from the glands. The natural blinking motion and blinking force causes the upper eyelid to pull the layer of lipids secreted by the meibomian glands over the two lower layers of the tear film, thus forming a protective coating that limits the rate at which the lower layers evaporate. It is estimated that approximately 65% ​​of meibomian gland disease or dry eye results from a defective lipid layer or insufficient amounts of such lipids, resulting in accelerated evaporation of the aqueous layer. Therefore, blinking disorders or other disorders that affect proper tear dispersion can also cause or exacerbate meibomian gland dysfunction or dry eye.

[0009] As the eyelids close in a full blink, the upper and lower conjunctival fornix, which hold the tear reservoir, are compressed by the force of the anterior orbital septum muscles, and the eyelids move toward each other. For example, the upper eyelid moves up the eye exerting a force on the ocular surface that helps to clear debris, insoluble mucin from the front of the eye, and also to express oily secretions from the meibomian glands. The lower eyelid moves horizontally toward the nose, pushing debris toward the lacrimal puncta, the openings that ultimately drain into the nasal cavity.

[0010] As the eyelids open, the tear film is redistributed, the upper eyelid pulls the aqueous phase through capillary action, and the lipid layer spreads as fast as the eyelid moves. Thus, eyelid movement is therefore important in tear film renewal, distribution, turnover, and drainage.

[0011] For a variety of reasons, the meibomian glands can become blocked, clogged, or obstructed, resulting in meibomian gland dysfunction and dry eye disease. The obstruction that causes the disease can occur anywhere within the gland, for example, at the surface or pores of the gland which impede the flow of normal lipid secretions, within the main pathway of the gland which may be narrowed or blocked, or elsewhere deeper within the gland which connects to the main pathway.

[0012] Treatment for blocked meibomian glands may include some conventional treatments. One course of treatment may include soap and detergent, eyelid washing, or application of antibiotics to reduce eyelid inflammation. Antibiotics such as tetracycline, doxycycline, metronidazole, or erythromycin may be administered orally or topically and may help regulate or improve meibomian gland lipid production. Inflammation on the ocular surface may also be controlled using topical drugs such as corticosteroids or cyclosporine (RESTASIS®, Allergan, Inc. (CA)), or other anti-inflammatory compounds or immunosuppressants. There is evidence suggesting that ocular surface inflammation is not only associated with meibomian gland dysfunction, but also with dry eye syndrome.

[0013] Other examples of dry eye treatments may include the application of prescription eye inserts for people with moderate to severe dry eye symptoms who cannot use artificial tears. Eye inserts, such as hydroxypropyl cellulose (LACRISERT®, Merck & Co., Inc. (NJ)), may be inserted between the lower eyelid and the eye. The inserts slowly degrade and release substances that lubricate the eye. Alternatively, specialized contact lenses may be used to occlude the surface of the eye and trap moisture.

[0014] In other treatments, the patient's tear ducts may be blocked to prevent the tear film from rapidly draining from the surface of the eye by procedures such as inserting punctal plugs into the tear ducts or cauterizing the tissue at the drainage area. Apart from implant or cauterization treatments, dry eye syndrome may be treated using medicinal products such as eye drops, eye-coating ointments, etc. Artificial tears, gels, ointments, autologous serum tears, or albumin drops have all been employed in the treatment of dry eye.

[0015] In addition, hot compresses are also typically used to restore meibomian gland function by being placed over the eye and incorporating eyelid massage to melt any lipid plugs and further express meibomian gland contents. However, application of hot compresses requires application two to three times a day, during which the patient may inadvertently target only one of the affected eyelids, and the hot compress prevents the patient from seeing through the eye being treated. The hot compress may be too hot, further exacerbating inflammation, or too cold, preventing proper therapeutic effects.

[0016] Other treatment devices have also been developed that cover the entire affected eye and apply heat and massage forces directly to the affected eyelid. However, devices such as hot cloths require the patient's eye to be completely occluded, albeit temporarily, during treatment, resulting in discomfort, loss of productivity, and potentially low compliance among patients. In addition, these treatments require a visit to a doctor or health care provider, making them unsuitable for widespread consumer adoption.

[0017] Thus, there is a need for methods and devices that are relatively simple for daily use by a patient, that allow the patient to continue their normal activities, that are non-intrusive and non-disruptive, and that utilize the patient's natural physiological activity to facilitate treatment. Summary of the Invention [Means for solving the problem]

[0018] In treating conditions such as meibomian gland dysfunction or dry eye syndrome, patches or strips can be affixed to the skin of the upper and / or lower eyelid 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. In particular, an assembly for a therapeutic strip(s) may generally comprise one or more strips configured to adhere to an underlying region of skin adjacent one or both of a subject's eyes such that the one or more strips allow the subject to blink naturally without restriction from the one or more patches. Additionally, the one or more strips may be configured to emit energy to the underlying region of skin, the one or more strips shaped to follow the location of one or more meibomian glands contained within the underlying region of skin.

[0019] In use, the one or more strips may be adhered to an area of ​​skin adjacent one or both of the subject's eyes such that the one or more strips allow the subject to blink naturally without restriction from the one or more patches. While adhered, the strips may emit energy into the area of ​​skin, and the one or more strips are shaped to follow the location of one or more meibomian glands contained within the area of ​​skin. Alternatively, the strips may be directly attached to the meibomian glands or other ocular tissue. The bulbar or orbital glands may not be covered and may ultimately supply the glands, deliver energy to the underlying nearby vasculature, or absorb energy therefrom. In other words, these strips may be used to heat or cool the blood supply to the eyelids, meibomian glands, and / or lacrimal glands, thereby affecting their function and metabolism, in certain variations, without necessarily covering them directly.

[0020] The upper strip may thus have an upper curved or arcuate periphery that is shaped to extend and follow the upper (or upper) boundary of the meibomian gland (such as along or to the upper eyelid crease), while the straight periphery of the lower edge may be shaped to extend and follow the lower (or lower) boundary of the meibomian gland, such as along the free edge of the upper eyelid. Although straight, the lower edge may be more curved or arcuate in alternative variations. The lower strip may similarly extend and follow the upper (or upper) boundary of the meibomian gland along the free edge of the lower eyelid. and a lower curved or arcuate edge that extends along the lower eyelid and follows the lower (or inferior) boundary of the meibomian gland (such as along or to the lower eyelid crease). Alternatively, the upper edge of the lower strip may also be highly curved or arcuate in alternative variations as well.

[0021] In other words, with the tarsal plate, containing the meibomian glands, spanning from proximally to distally, the peripheral edge of the treatment strip may correspond to the distal lid margin, and the proximal peripheral edge and treatment strip may assume a number of configurations. In general, the peripheral distal edge of the treatment strip may be relatively straight or gently curved, either of which can follow the lower distal lid margin and tarsal plate, while having the relatively curved proximal peripheral edge take on the more curved proximal edge of the lower tarsal plate.

[0022] The strips may be used for placement on the upper eyelid only or the lower eyelid only individually depending on the treatment desired. Furthermore, the length of the treatment strips may also be varied as desired to target individual meibomian glands to provide targeted treatment, as described in further detail herein. In addition, the treatment strips are generally sized, but may also be customized or sized for specific individual eyelid dimensions.

[0023] Due to the specific contoured size and flexibility of the treatment strip, the treatment strip can be placed on the patient and apply therapy to the underlying meibomian glands, allowing the patient's eyes to open and close normally without interference from one or both of the treatment strips. Thus, the contoured size, shape, and flexibility of the treatment strip allows treatment to occur while also allowing the patient to hold one or both eyes open so that normal physiological blinking can occur during the course of treatment. Rather than relying on the application of any type of external force, the treatment strip utilizes the eye's natural mechanism for clearing oils from the meibomian glands via blinking. Thus, the treatment strip can be glued in place for treatment without any further intervention by the patient or health care provider, such that the eye remains unobstructed and is allowed to blink naturally, while the treatment strip can, for example, apply thermal energy to melt or liquefy any waxy or solid meibomian gland obstructions. The therapeutic strips therefore allow the natural blinking force to dislodge the heat-treated softened obstruction from the gland before it re-solidifies, unlike other treatments which require the patient to keep their eyes closed or obstructed during the course of treatment, preventing or inhibiting the patient from blinking.

[0024] The therapeutic strip may be configured to have a contact layer (e.g., fabricated from a conductive material such as metal, alloy, porous ceramic, engineering ceramic, wood, polymer, composite, foam, polymer foam, fabric, elastomer, etc.) that may protect the skin from burns or any other adverse effects. A second heating layer may be applied to the contact layer to generate thermal energy. A layer may be positioned above the heating layer (or directly in contact with the skin), and an insulating layer may be positioned on top of the heating layer to focus, direct, or reflect heat toward the underlying skin surface and protect other parts of the patient's body from contacting the heating layer. The insulating layer may thus be fabricated from a variety of insulating materials, such as foam, foam tape, gauze, silicone, microporous polyethylene film, fabric, polymers, and the like.

[0025] Although application of thermal energy from a therapeutic strip is described, other variations may include application of the therapeutic strip to cool the underlying skin instead. Rather than using a heating layer in an exothermic reaction, the layer may instead be configured to utilize an endothermic reaction to provide cooling of the skin. Cooling, rather than heating, may be applied to conditions such as reducing inflammation, allergies, or relieving tired eyes, particularly when the patient is at rest or sleeping.

[0026] In addition to the application of thermal energy from the therapeutic strips, the strips may also be used alone or in combination with thermal therapy. The contact layer, insulating layer, or separate layer may include a layer for diffusion or release of one or more pharmaceutical, biological, or chemical agents, either in combination with the contact layer, insulating layer, or separate layer. For example, pharmaceutical, biological, or chemical agents may be incorporated entirely into either the contact layer, insulating layer, or separate layer for transdermal delivery to the meibomian glands or areas surrounding the meibomian glands for additional and / or alternative treatments. If a pharmaceutical or chemical agent is released during heat treatment, the heat may help improve penetration of any drug into the underlying skin.

[0027] The treatment strips may incorporate various layers within the strip to provide a variety of different treatments, but the strips may also vary in size, shape, contour, etc. depending on the desired treatment area, so long as the treatment strip is contoured or shaped to follow the location of at least one meibomian gland.

[0028] The therapeutic strips may be applied to one or more of the meibomian glands, although variations of the strips may also be used to treat other glands, such as, for example, sebaceous glands for the treatment of acne. Therapeutic strips used to treat acne may utilize different pharmacological treatments. Additionally, therapeutic strips may potentially be used to treat ocular disorders other than meibomian gland dysfunction.

[0029] Yet another example may include the use of treatment strips to treat disorders of the lacrimal gland and / or palpebral lacrimal gland located above the eye. Variously sized treatment strips, such as a lacrimal gland strip sized to have a curved upper periphery, may be sized for placement directly over the skin surface above where the lacrimal gland is located. The lacrimal gland and / or palpebral lacrimal gland may be treated alone or in combination with treatment strips contoured for treatment of the meibomian gland.

[0030] The treatment strip may be applied over the meibomian glands to apply thermal energy, but the treatment does not require the application of any external force applied by the strip or any other external device, and may utilize the patient's natural blinking to facilitate the treatment. However, in additional variations, the treatment strip may be configured to apply both thermal therapy as well as an external force. Any number of mechanisms may be utilized to apply a clamping or biasing force and provide compression of the underlying skin and meibomian glands during application of thermal therapy.

[0031] In addition to compressive forces, the strips may be formed with alternative components, such as mechanical components to impart vibrational or other forms of energy to enhance meibomian gland expression and encourage oil secretion.

[0032] In yet another variation, one or both therapeutic strips may be configured to incorporate an indicator, e.g., an LED light, an alarm, a vibrating element, etc., electrically coupled to a power source and / or processor, that alerts the patient when the prescribed treatment is complete. This feature (and any of the other features) may be combined, where practicable, with any of the other variations of therapeutic strips described herein.

[0033] With the incorporation of a processor within the therapeutic strip, other parameters such as treatment time or temperature of the strip may be programmed and turned on or off at will, either selectively by the patient or automatically. Additionally, other parameters such as frequency of heat delivery or other stimulation may also be programmed by the processor, providing further flexibility in treatment. In one embodiment, the present invention provides, for example, the following items: (Item 1) A therapeutic assembly for dry eye syndrome, comprising: one or more strips configured to adhere to an underlying area of ​​skin adjacent one or both eyes of a subject, the one or more strips enabling the subject to blink naturally without restriction from the one or more strips; the one or more strips are configured to emit energy to an underlying area of ​​the skin; the strip is shaped to follow the location of one or more meibomian glands contained within the underlying area of ​​skin; assembly. (Item 2) 2. The assembly of claim 1, wherein the energy comprises thermal energy. (Item 3) 2. The assembly of claim 1, wherein the one or more strips comprise a contact surface for placement against the area of ​​skin. (Item 4) Item 13. The assembly of item 1, wherein the one or more strips comprise a heating layer in thermal communication with the area of ​​skin. (Item 5) Item 5. The assembly of item 4, further comprising a thermochromic layer in thermal communication with the heating layer. (Item 6) 5. The assembly of claim 4, wherein the heating layer is configured to generate heat in a temperature range of about 20° C. to 55° C. (Item 7) 5. The assembly of claim 4, wherein the heating layer is configured to generate heat for a period of about 5 minutes to 24 hours. (Item 8) Item 13. The assembly of item 1, wherein the one or more strips comprise a cooling layer in thermal communication with the area of ​​skin. (Item 9) Item 9. The assembly of item 8, wherein the cooling layer is configured to reduce a temperature over a range of about 0° C. to 37° C. (Item 10) 9. The assembly of claim 8, wherein the cooling layer comprises a hydrogel layer. (Item 11) 2. The assembly of claim 1, wherein the one or more strips comprise an insulating layer. (Item 12) Item 2. The assembly of item 1, wherein the one or more strips each have a first curved or arcuate periphery and a second straight periphery, the first curved or arcuate periphery shaped to extend and follow the border of the one or more meibomian glands, and the second straight periphery shaped to extend and follow the free edge of the upper or lower eyelid. (Item 13) 2. The assembly of claim 1, wherein the one or more strips each have a length in the range of about 1 mm to 50 mm. (Item 14) 2. The assembly of claim 1, wherein the one or more strips each have a width in the range of about 1 mm to 25 mm. (Item 15) Item 14. The assembly of item 1, further comprising a controller attached to the one or more strips. (Item 16) Item 16. The assembly of item 15, wherein the controller is programmed to control one or more parameters of the one or more strips. (Item 17) 17. The assembly of claim 16, wherein the one or more parameters comprise temperature, treatment time, frequency of treatment, or thermal profile of the one or more strips. (Item 18) Item 14. The assembly of item 1, further comprising one or more additional strips configured to adhere to a second area of ​​skin adjacent to the subject's lacrimal gland. (Item 19) Item 1. The assembly of item 1, further comprising one or more biasing mechanisms positioned along the one or more strips, the one or more biasing mechanisms configured to apply pressure to the underlying region of the skin. (Item 20) Item 1, the assembly of item 1, further comprising one or more actuators positioned along the one or more strips, the one or more actuators configured to impart mechanical vibrations to the underlying region of the skin. (Item 21) 2. The assembly of claim 1, further comprising an electrically conductive or resistive element positioned along the one or more strips. (Item 22) 22. The assembly of claim 21, wherein the electrically conductive element comprises an electrode. (Item 23) 22. The assembly of claim 21, wherein the electrically conductive element comprises a microwave antenna. (Item 24) 2. The assembly of claim 1, further comprising an indicator positioned along the one or more strips. (Item 25) 25. The assembly of claim 24, wherein the indicator comprises an audible or visual alarm for alerting the subject. (Item 26) and one or more pharmaceutical, biological, or chemical agents injected within or along said one or more strips. Item 2. The assembly according to item 1. (Item 27) 2. The assembly of claim 1, further comprising a power source positioned along the one or more strips. (Item 28) 28. The assembly of claim 27, wherein the power supply is rechargeable. (Item 29) 1. A method for treating dry eye syndrome, comprising: adhering one or more strips to an area of ​​skin adjacent to one or both eyes of a subject, said one or more strips enabling said subject to blink naturally without restriction from said one or more strips; emitting energy from said one or more strips to said area of ​​skin; Including, the one or more strips are shaped to conform to the location of one or more meibomian glands contained within the area of ​​skin; method. (Item 30) The bonding step includes: positioning the one or more strips adjacent to one or both eyes, wherein a first curved or arcuate periphery of the one or more strips extends and follows the border of the one or more meibomian glands and a second straight periphery of the one or more strips extends and follows the free edge of the upper or lower eyelid. 30. The method according to item 29, comprising: (Item 31) 30. The method of claim 29, wherein the adhering step comprises placing a contact surface of the one or more strips against the area of ​​skin. (Item 32) 30. The method of claim 29, wherein the step of emitting energy comprises applying thermal energy from a heating layer in the one or more strips to the underlying region of the skin. (Item 33) the one or more heat sources via a thermochromic layer in thermal communication with the heating layer; 33. The method of claim 32, further comprising indicating a change in temperature of the strip. (Item 34) Item 33. The method of item 32, wherein applying thermal energy from a heating layer comprises increasing a temperature of the one or more strips to a temperature range of about 20° C. to 55° C. (Item 35) Item 33. The method of claim 32, wherein the step of applying thermal energy from a heating layer comprises applying the thermal energy for a period of about 5 minutes to 24 hours. (Item 36) 30. The method of claim 29, wherein the step of emitting energy comprises removing thermal energy from the underlying region of the skin via a cooling layer in the one or more strips. (Item 37) Item 37. The method according to item 36, wherein the step of removing thermal energy includes a step of cooling the cooling layer to a temperature range of about 0°C to 37°C. (Item 38) 30. The method of claim 29, wherein the one or more strips each have a length in the range of about 1 mm to 50 mm. (Item 39) 30. The method of claim 29, wherein the one or more strips each have a width in the range of about 1 mm to 25 mm. (Item 40) 30. The method of claim 29, further comprising programming the one or more strips via a controller attached to the one or more strips. (Item 41) Item 41. The method of item 40, wherein the programming step includes controlling one or more parameters of the one or more strips. (Item 42) Item 42. The method of item 41, wherein the controlling step comprises controlling the temperature, treatment time, frequency of treatment, or thermal profile of the one or more strips. (Item 43) 30. The method of claim 29, further comprising adhering one or more additional strips to a second area of ​​skin adjacent to the subject's lacrimal gland. (Item 44) 30. The method of claim 29, further comprising applying pressure or force to the underlying area of ​​the skin via one or more biasing mechanisms positioned along the one or more strips. (Item 45) 30. The method of claim 29, further comprising the step of applying mechanical vibration to the underlying area of ​​the skin. (Item 46) 30. The method of claim 29, further comprising the step of applying an electrical force or electrical stimulation to the underlying area of ​​the skin. (Item 47) 30. The method of claim 29, further comprising the step of issuing a warning to the subject via an indicator positioned along the one or more strips. (Item 48) Item 30. The method of claim 29, further comprising the step of applying one or more pharmaceutical, biological, or chemical agents to the underlying skin via the one or more strips. How to. (Item 49) 30. The method of claim 29, wherein the method of treating dry eye syndrome further comprises treating meibomitis, blepharitis, anterior blepharitis, posterior blepharitis, or ocular rosacea. (Item 50) 30. The method of claim 29, further comprising stimulating the subject to promote blinking, induce blinking, or maintain longer closure during blinking. (Item 51) A treatment system for dry eye syndrome, comprising: one or more strips configured to adhere to an underlying area of ​​skin adjacent one or both eyes of a subject, said one or more strips enabling said subject to blink naturally without restriction from said one or more strips; a controller in communication with the one or more strips, the controller being programmable for a therapeutic regimen; Equipped with the one or more strips are configured to emit energy into the underlying region of the skin, the one or more strips being shaped to follow the location of one or more meibomian glands contained within the underlying region of the skin. system. (Item 52) 52. The system of claim 51, wherein the energy comprises thermal energy. (Item 53) Item 52. The system of item 51, wherein the one or more strips comprise a contact surface for placement against the area of ​​skin. (Item 54) Item 52. The system of item 51, wherein the one or more strips comprise a heating layer in thermal communication with the area of ​​skin. (Item 55) 55. The system of claim 54, further comprising a thermochromic layer in thermal communication with the heating layer. (Item 56) Item 52. The system of item 51, wherein the one or more strips each have a first curved or arcuate periphery shaped to extend and follow the border of the one or more meibomian glands and a second curved or arcuate periphery shaped to extend and follow the free edge of the upper eyelid or lower eyelid. (Item 57) Item 52. The system of item 51, wherein the controller is coupled to the one or more strips via a connecting cable. (Item 58) Item 52. The system of item 51, wherein the controller is programmed to control one or more parameters of the one or more strips. (Item 59) 52. The system of claim 51, wherein the one or more parameters include one or more of a temperature of the strip, a treatment time, a frequency of treatment, or a thermal profile. (Item 60) Item 52. The system of item 51, further comprising a portable electronic device removably coupled to the controller. (Item 61) Item 61. The system of item 60, wherein the portable electronic device includes a smartphone or a tablet. (Item 62) Item 62. The system of item 61, wherein the smartphone is programmed to provide audio, visual, or tactile indicators for communicating with the user. (Item 63) 1. A method for treating dry eye syndrome, comprising: adhering one or more strips to an area of ​​skin adjacent to one or both eyes of a subject, said one or more strips enabling said subject to blink naturally without restriction from said one or more strips; initiating treatment of the area of ​​skin with the one or more strips via a controller in communication with the one or more strips; emitting energy from the one or more strips to the area of ​​skin, the one or more strips being within a range of one or more of the areas of skin; and shaped to follow the location of one or more meibomian glands. (Item 64) The bonding step includes: positioning the one or more strips proximate one or both eyes, wherein a first curved or arcuate periphery of the one or more strips extends and follows the border of the one or more meibomian glands and a second curved or arcuate periphery of the one or more strips extends and follows the free edge of the upper or lower eyelid. Item 64. The method according to item 63, comprising: (Item 65) Item 64. The method of item 63, wherein adhering comprises placing a contact surface of the one or more strips against the area of ​​skin. (Item 66) Item 64. The method of item 63, wherein the step of emitting energy comprises the step of applying thermal energy from a heating layer in the one or more strips to the underlying area of ​​the skin. (Item 67) Item 64. The method of item 63, wherein the initiating step includes programming the one or more strips via a controller attached to the one or more strips. (Item 68) Item 68. The method of item 67, wherein the programming step includes controlling one or more parameters of the one or more strips. (Item 69) Item 68. The method of item 67, wherein the controlling step includes controlling the temperature, treatment time, frequency of treatment, or thermal profile of the one or more strips. (Item 70) Item 64. The method of item 63, wherein the initiating step further comprises the step of displaying at least one parameter on a portable electronic device removably coupled to the controller. (Item 71) 71. The method of claim 70, further comprising interacting with a touch screen interface of the electronic device. (Item 72) 71. The method of claim 70, further comprising the step of wirelessly communicating with the electronic device at a remote server. [Brief description of the drawings]

[0034] [Figure 1A] FIG. 1A shows a cross-sectional side view of the upper eyelid and an example of the location of the meibomian glands. [Figure 1B] FIG. 1B shows a front view of the distribution of meibomian glands in a human eyelid with the upper and lower eyelids in a closed position, such as when the patient blinks, and the alignment of the meibomian glands across both the upper and lower eyelids. [Figure 1C] FIG. 1C shows a perspective view of a patient's eye in an open position, illustrating how the meibomian glands are typically aligned relative to one another when the patient's eye is open. [Figure 2A] FIG. 2A shows a front view of a patient's eye in a closed position with an example of a therapeutic strip adhered onto the upper or lower eyelid (or both), the strip being sized or contoured for placement directly over the meibomian gland located in the lower eyelid. [Figure 2B] Figure 2B shows the therapeutic strip of Figure 2A illustrating how the strip can remain adhered to the patient's skin while allowing the eyelid to retract, allowing the patient to continue blinking while seeing normally through the eye. The strip may be applied from the lid margin to the lid crease, but may alternatively flex or fold and / or compress during blinking to prevent interference with normal blinking and maximize comfort. [Figure 3A] FIG. 3A shows an example of a contoured therapeutic strip. [Figure 3B] FIG. 3B shows an example of a cross-sectional side view of a therapeutic strip. [Figure 3C] FIG. 3C shows another variation of a therapeutic strip that may optionally incorporate a controller. [Figure 3D] FIG. 3D shows yet another variation in which the therapeutic strips may be formed into a zigzag or curved configuration to encourage blinking by the patient. [Figure 4]FIG. 4 shows a front view of another variation of a treatment strip that is relatively thin and is positioned over the upper eyelid. [Diagram 5] FIG. 5 shows a front view of another variation of a relatively thick treatment strip for treatment of the target meibomian glands as well as surrounding tissue. [Figure 6] FIG. 6 shows a front view of another variation of a treatment strip that is contoured to more closely follow the meibomian glands in the upper eyelid. [Figure 7] FIG. 7 shows a front view of another variation of a treatment strip that can be formed into a shortened strip for selective placement along the eyelid. [Figure 8] FIG. 8 shows a front view of another variation of a treatment strip that is relatively thin and contoured for placement along the lower eyelid. [Figure 9] FIG. 9 shows a front view of another variation of a treatment strip that is relatively thick and also contoured for placement along the lower eyelid. [Figure 10] FIG. 10 shows a front view of another variation of a treatment strip that is relatively thick for placement along the lower eyelid. [Figure 11] FIG. 11 shows a front view of another variation of a treatment strip that is contoured for the lower eyelid and can be shortened to various lengths. [Figure 12] FIG. 12 shows a front view of another variation of a treatment strip that is relatively straight and optionally shortened. [Figure 13] FIG. 13 shows a front view of another variation of contoured treatment strips and further illustrates how differently sized strips can be used in combination with one another. [Figure 14] FIG. 14 shows a front view of another variation of a treatment strip that is sized to follow not only the meibomian glands along the lower eyelid, but also the surrounding tissue areas. [Figure 15] FIG. 15 shows a front view of another variation of a treatment strip sized to follow the meibomian glands along the lower eyelid along with the surrounding tissue areas. [Figure 16]FIG. 16 shows a front view of yet another variation in which the strips are contoured to follow at least a portion of the meibomian glands, but also cover selected areas of the surrounding tissue. [Figure 17] FIG. 17 shows a front view of yet another variation that is selectively contoured to treat specific areas of underlying tissue. [Figure 18] FIG. 18 shows a front view of yet another variation in which contoured treatment strips may be used in combination for treatment of both the upper and lower eyelids. [Figure 19] FIG. 19 shows a front view of yet another variation in which the treatment strips may be color modified to more closely match the underlying skin tone. [Figure 20] FIG. 20 shows a front view of yet another variation in which treatment strips can be sized to treat designated meibomian glands. [Figure 21] FIG. 21 shows a front view of yet another variation in which the strips can be varied in size to selectively treat specific meibomian glands. [Figure 22] FIG. 22 shows a front view of yet another variation in which treatment strips can be sized to treat individual meibomian glands. [Diagram 23] FIG. 23 shows a front view of yet another variation in which the treatment strips may be sized for placement along the lower eyelid. [Figure 24] FIG. 24 shows a front view illustrating the relative positioning of the lacrimal glands. [Diagram 25] 25-27 show variations of treatment strips that can be contoured and positioned to treat the inferior lacrimal gland. [Figure 26] 25-27 show variations of treatment strips that can be contoured and positioned to treat the inferior lacrimal gland. [Figure 27] 25-27 show variations of treatment strips that can be contoured and positioned to treat the inferior lacrimal gland. [Figure 28]28-30 show variations of treatment strips that can also be contoured and sized to treat the meibomian glands, optionally in combination with treating the lacrimal glands. [Figure 29] 28-30 show variations of treatment strips that can also be contoured and sized to treat the meibomian glands, optionally in combination with treating the lacrimal glands. [Diagram 30] 28-30 show variations of treatment strips that can also be contoured and sized to treat the meibomian glands, optionally in combination with treating the lacrimal glands. [Diagram 31] 31 and 32 show variations of treatment strips that can be sized to treat specific meibomian glands, optionally in combination with the lacrimal glands. [Diagram 32] 31 and 32 show variations of treatment strips that can be sized to treat specific meibomian glands, optionally in combination with the lacrimal glands. [Diagram 33] FIG. 33 shows another variation of a therapeutic strip that may have mechanically biasing features incorporated along the strip to apply force to the underlying tissue and meibomian glands. [Diagram 34] FIG. 34 shows a detailed perspective view of the therapeutic strip of FIG. 33 illustrating an embodiment of a biasing mechanism incorporated along the strip. [Diagram 35] FIG. 35 shows another variation of a therapeutic strip that incorporates one or more transducers for applying a vibrational force to the underlying tissue and meibomian glands. [Diagram 36] FIG. 36 shows yet another variation of a therapeutic strip that incorporates electrodes throughout the length of the strip. [Figure 37] FIG. 37 shows yet another variation of a therapeutic strip that incorporates microwave antennas along the strip. [Figure 38] FIG. 38 shows yet another variation of the treatment strip that incorporates a timer and indicator to alert the user when treatment is complete. [Figure 39]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 PREFERRED EMBODIMENTS

[0035] In treating conditions such as meibomian gland dysfunction (MGD), commonly associated with evaporative forms of dry eye syndrome (DES), patches, strips, or thin adhesive devices are 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. In particular, the therapeutic strip(s) may be specifically configured and sized for placement over one or more targeted meibomian glands within the skin of the upper and / or lower eyelids. Thermal therapy, e.g., application of heat or cold, can traverse the eyelids very easily because the eyelids are generally the thinnest skin found on the human body and the tissue is highly vascularized. With the proximal lid root and distal lid margin, the net arterial flow flows from proximal to distal. Therefore, regardless of where these therapeutic strips are placed, heat or cold therapy can be easily delivered throughout the eyelid and any structures contained therein, such as the meibomian gland MG, lacrimal gland LG, Zeiss gland GZ, Moll's gland GM, Wolfring's gland GW, Krause's gland GK, etc.

[0036] Additionally, because the eyelids are very thin, the heating or cooling therapy may also be delivered to the ocular surface and the eye itself (as described in more detail below). Thus, the therapy may deliver energy to the conjunctiva, goblet cells, episcleral vasculature, cornea, aqueous humor, iris, ciliary body, and potentially the anterior vitreous and crystalline lens. Thus, any thermal therapy with therapeutic strips may also be delivered and used to treat ocular surface and anterior ocular diseases, such as conjunctivitis, keratitis, keratopathy, iritis, cyclitis, glaucoma, cataracts, etc. Also, it may be used in post-operative conditions, such as after LASIK, PRK, or cataract or corneal surgery, or other ocular, periocular, intraocular, or eyelid surgery, as described in more detail below.

[0037] As shown in the front view of FIG. 2A, one variation of such a treatment strip may be shown for illustrative purposes as temporarily adhered over the upper eyelid UL and lower eyelid LL, covering the eye of a patient P when closed. The contoured upper strip 10 may be sized for adhesion directly onto the skin of the upper eyelid UL, such 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 upper eyelid UL. Similarly, the contoured lower strip 12 may 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 contoured strip may stop at or beyond the eyelid crease, as described in other variations below.

[0038] The upper strip 10 may thus have an upper curved or arcuate periphery 14 that is shaped to extend and follow the upper (or upper) boundary of the meibomian gland (such as along or to the upper eyelid crease), while the lower straight periphery 16 may be shaped to extend and follow the lower (or lower) boundary of the meibomian gland, such as along the free edge of the upper eyelid UL. The lower strip 12 may similarly have an upper straight periphery 20 that extends and follows the upper (or upper) boundary of the meibomian gland along the free edge of the lower eyelid LL, and a lower curved or arcuate periphery 18 that extends and follows the lower (or lower) boundary of the meibomian gland along the lower eyelid LL (such as along or to the lower eyelid crease). The use of the terms "lower" and "upper" herein refers to the periphery of the therapeutic strip when placed on a patient P (human or animal) and is used herein for descriptive purposes.

[0039] Although the treatment strips 10, 12 are both shown adhered onto the individual upper and lower eyelids UL and LL, the strips 10, 12 may be used for placement on only the upper eyelid UL or only the lower eyelid LL, individually, depending on the treatment desired. Additionally, the length of the treatment strips 10, 12 may also be varied to target individual meibomian glands, as desired, to provide targeted treatment, as described in further detail herein.

[0040] Although the treatment strips 10, 12 are shown positioned on the closed eyelid of patient P, the strips 10, 12 may be sufficiently arcuate or flexible to take up the curvature of the patient's eyelid margin and may be of sufficient length to cover some or all of the underlying meibomian glands at the tarsal plate. The treatment strips 10, 12 may be generally sized, but may also be customized or sized for a specific individual's eyelid dimensions or shaped to optimize adhesion and / or comfort and / or stability. Generally, the treatment strips 10, 12 may have lengths of about 1 mm to 50 mm, depending on the desired treatment length and patient anatomical considerations, since a typical palpebral fissure length in an adult is about 27 mm to 30 mm. Thus, to cover substantially all of the meibomian glands, the treatment strips 10, 12 may be sized to have a length of, for example, 25 mm to 30 mm, or if sized to cover slightly more than the entire meibomian gland, may be sized to have a length of, for example, 30 mm to 50 mm (or longer if required to optimize adhesion / comfort / stability). Further, one or both treatment strips 10, 12 may be sized to have a length of, for example, 25 mm to 30 mm, or longer if required to optimize coverage of the typical eyelid wrinkles of a Caucasian male. For white women, it is about 8mm-9mm above the lid margin, while for white women, it is about 9mm-11mm above the lid margin, so can have a width of about 1mm-25mm (or more, if needed for adhesion / comfort and potentially increased efficacy from heating or cooling the incoming blood flow). Customization allows for fitting to any particular anatomy, race, ethnicity, etc. Additionally, the therapeutic strips may be manufactured with variable levels of flexibility to accommodate the ergonomics of the eyelid and lid blink for optimal comfort and minimal interference or movement.

[0041] Because of the specifically contoured size and flexibility of the treatment strips 10, 12, the treatment strips may be placed on the patient P by the patient himself for consumer use or by a healthcare provider to apply therapy to the underlying meibomian glands, allowing the patient's eyes to open and close normally without interference from one or both treatment strips, as shown in Figure 2B. The strips may be applied from the lid margin to the lid crease, but may alternatively flex or fold and / or compress during blinking to prevent interference with normal blinking and maximize comfort.

[0042] Typical treatment patches, such as those used for applying hot compresses, are generally sized to be placed over one or both eyes so that the patient cannot open or blink their eye during the treatment session. However, due to the strong association between DES and MGD (e.g., MGD includes areas of MGD, meibomianitis, blepharitis, and rosacea), the natural blinking of an individual is the mechanism by which meibomian gland secretions are normally released onto the eyelid margin and into the tear. When blinking does not occur, the oil contained within the meibomian gland remains unexpressed from within the terminal ducts of the gland and is unable to contribute to the dispersion of the oil-like layer onto the tear.

[0043] Thus, the contoured size, shape, and flexibility of the treatment strips 10, 12 allow treatment to occur while also allowing the patient to leave one or both eyes open so that normal physiological blinking can occur during the course of treatment. Rather than relying on the application of any type of external force to squeeze oil or obstruction out of the gland, the treatment strips 10, 12 utilize the eye's natural mechanism for clearing oil from the meibomian gland via blinking. Thus, the treatment strips 10, 12 can be glued in place for treatment without any further intervention by the patient or health care provider, such that the treatment strips 10, 12 can apply, for example, thermal energy to melt or liquefy any waxy or solid meibomian gland obstructions while the eye remains unobstructed and can blink naturally. The therapeutic strips 10, 12 therefore allow the natural blinking force to clear the heat treated softened obstruction from the gland before it resolidifies, unlike other treatments which require the patient to keep their eyes closed or obstructed during the course of treatment, preventing or inhibiting the patient from blinking. The delivery of heat can also increase blood flow by promoting vasodilation, as increased blood delivery affects metabolism, temperature of other tissues, and can affect inflammation, thereby improving tissue function.

[0044] Because some patients have obstructions or blockages in their meibomian glands that do not reach high temperatures in the meibomian glands and thus cannot fully melt, relax, or soften, the ability of the treatment strip 10, 12 to remain attached to the patient throughout the day and for any given period of time allows the treatment strip 10, 12 to apply heat or other treatment to the surface of the eyelid at higher treatment temperatures for a significant period of time for a relatively long treatment time. The patient can open their eyes, blink, and go about their daily activities with the strip-based treatment comfortable. Furthermore, the patient can wear the treatment strip as many times as necessary throughout the day, week, month, etc. until the dry eye symptoms subside. This increases the frequency of treatment, the convenience of treatment, and therefore the effectiveness of treatment.

[0045] Due to the extended treatment time, a separate application of force in addition to the application of the strips may not be required, so long as the patient is able to continue blinking during the course of treatment. Furthermore, the frequency of treatment may be varied depending on the severity of the condition being treated. One example of a potential treatment frequency may include application of one or both strips up to six times per day for 10 minutes or up to one hour or more per treatment. Furthermore, because the treatment strips are positioned over the meibomian glands, which cover the ocular surface, application of heat therapy may also indirectly heat the ocular surface as well, further reducing any chronic ocular surface inflammation, chronic conjunctival inflammation, or corneal neovascularization.

[0046] In addition to heating the ocular surface, thermal therapy may also optionally be used to provide thermal therapy and potentially provide indirect heating through the ocular surface for heating the retina to limit inflammation and neovascularization that are the underlying causes of diseases such as wet age-related macular degeneration (AMD) and diabetic retinopathy.

[0047] The therapeutic strips 10, 12 may be used throughout the day, taking advantage of the patient's physiological blinking, but the therapeutic strips 10, 12 may also be used while the patient is at rest or asleep, or while the patient simply holds their eyes closed.

[0048] The treatment strips 10, 12 are desirably sufficiently flexible to accommodate movement of the upper eyelid UL and / or lower eyelid LL, which may move approximately 15 mm or more. Accordingly, the treatment strips 10, 12 may be fabricated from a variety of materials. Figures 3A and 3B show front and cross-sectional side views, respectively, of an embodiment of a treatment strip configured to leave an adhesive 32 located about the periphery of the strip in a contact area 30 for placement directly against a skin surface. The contact area 30 may further include a moisturizing layer that interfaces between the strip and the skin to facilitate heat transfer from the strip and provide moisturizing therapy to the skin. Alternatively, the treatment strip may be used in conjunction with any number of moisturizing agents that may be applied to the underlying skin by the patient P or practitioner separately from the treatment strip. Additionally, the contact area 30 may be formed to have a surface that is smooth, porous, irregular, corrugated, etc., to facilitate contact and transfer of heat from the treatment strip to the skin surface. Alternatively, the entire contact area 30, including its periphery, may be adhesive and maintain good contact. It may be hinged or curved to allow flexing or accordion-like dynamic movement for comfort and more physiologically sensible ergonomics. In use, the strip may be applied under tension, as shown by tensioned strip 10' in FIG. 3D, further reducing any interference with blinking, and once adhered to the skin, the strip may be released to allow its flexing, as shown by released strip 10'' in FIG. 3D, similarly facilitating blinking by the patient P.

[0049] In this variation, the therapeutic strip 10 may be configured with a contact layer 34 (e.g., fabricated from a conductive material such as metal, alloy, porous ceramic, engineering ceramic, wood, polymer, composite, foam, polymer foam, elastomer, etc.) that may protect the skin from burns or any other adverse effects. A second heating layer 36 may be positioned above the contact layer 34 (or directly in contact with the skin) to generate thermal energy, and an insulating layer 38 may be positioned on top of the heating layer 36 to focus, direct, or reflect the heat toward the underlying skin surface and protect other parts of the patient's body from contacting the heating layer 36. The insulating layer 38 may thus be fabricated from a variety of insulating materials, such as foam, foam tape, gauze, silicone, microporous polyethylene film, metal, alloy, reflective material, mirror, etc. Additionally, the thickness of the therapeutic strip 10 may vary, for example, from about 1 / 64 inch to 1 / 8 inch or more, depending on the heating layer 36 configuration and the desired thermal profile and target transmission temperature. Additionally and / or alternatively, the insulating layer 38 may be a thermochromic material that may change color when a target temperature is reached by the therapeutic strip 10. The device may consist of a thermometer and a thermometer that indicates to the patient that the target temperature has been achieved or that therapy is complete. stomach.

[0050] The heating layer 36 may be configured to generate its thermal energy through any number of different mechanisms, such as mechanical, electrical, or chemical mechanisms, for example, to a temperature range of about 20° C. to 55° C. (or higher), or 40° C. to 50° C. In one variation, the heating layer 36 may comprise an air-activated warmer that may raise the temperature to a high therapeutic temperature for a period lasting, for example, from 5 minutes to 24 hours or more. Examples may include, for example, an air-activated layer incorporating iron. Other examples may include a heating layer 36 that incorporates, for example, cellulose, iron powder, water, activated carbon (to accelerate the reaction), vermiculite (water reservoir), and salt (catalyst), sawdust, sodium chloride, and water, etc., to generate heat from the exothermic oxidation of the iron when exposed to air. Other variations may include a heating layer 36 that incorporates light-based activation (powered by visible or UV light) or the use of a supersaturated solution (crystalline form) to initiate and / or sustain the exothermic reaction.

[0051] Optionally, in addition to the use of thermochromic materials to determine when the treatment strip has reached a particular temperature, a separate temperature sensor 39 (e.g., a thermocouple or thermistor device) may be incorporated onto the treatment strip 10, either attached to the top of the strip or to the bottom of the strip, as shown in FIG. 3B. The treatment strip 10 may also incorporate an optional controller and / or display 37 having a processor, which may be programmable and incorporate a separate on / off feature, as shown in FIG. 3C. The temperature sensor 39 may communicate with the controller 37, which may be programmed to adjust the temperature of the heating layer 36 and / or the length of time between particular treatments. The controller 37 may thus be programmable by a physician or caregiver or directly by the patient. Alternatively, the controller 37 may be configured to be inaccessible by the patient and may simply provide a temperature and / or time display for display to the patient. If the controller 37 is programmable, the controller 37 may be programmed, for example, to set the length of the heating cycle, set the treatment time, set a predetermined temperature range, control the heating temperature profile (such as gradually increasing the heating temperature or decreasing the temperature over a predetermined period of time), etc.

[0052] In another variation, the heating layer 36 may generate heat through exothermic crystallization of a supersaturated solution (typically sodium acetate), which is usually reusable. The therapeutic strips may be resupplied by heating them, e.g., to boiling, and allowing them to cool. Heating of these therapeutic strips may be induced by breaking a small metal device embedded within the therapeutic strip, which generates nucleation centers that initiate crystallization. Heat is required to dissolve the salt in its own crystallization water, and it is this that is released once crystallization has been initiated.

[0053] In yet another variation, the heating layer 36 may comprise a battery-operated warmer that utilizes an electrically resistive heating element that is used to convert electrical energy in a battery to thermal energy. The power source may be internal or external to the therapeutic strip, and the therapeutic strip may be charged, for example, by direct electrical contact, induction, etc.

[0054] Other mechanisms that may be incorporated into the heating layer 36 may include chemically actuated reactions, such as those used by sodium acetate heating pads. For example, one-time chemical reactions utilizing catalytic iron rusting or calcium chloride dissolution may be used, where reagents are maintained in separate compartments within the treatment strip. When the patient squeezes the treatment strip, the compartments break down and the reagents mix, generating heat. As an example, sodium acetate in water may be used to heat the treatment strip. The crystallization can be achieved by using a supersaturated solution of thorium (NaCH3COO), which acts as a nucleation site for the crystallization of sodium acetate into a hydrated salt (sodium acetate trihydrate). This can be induced by bending a small flat disk of a notched non-ferrous metal embedded in a liquid, acting as a magnet. Because the liquid becomes supersaturated, this causes the solution to suddenly crystallize, releasing the energy of the crystal lattice.

[0055] Yet another example of a use in the heating layer 36 may include the use of a hot gel containing a supersaturated solution of a salt. Heat may be generated as crystallization of a given salt occurs exothermically. Such a heating layer 36 may be reused by putting the salt back into solution within the heating layer 36.

[0056] Still other examples for incorporation into the heating layer 36 may also include the use of high specific heat capacity materials that may be heated, for example, by placing them in a microwave oven and then allowing them to release heat for a specified period of time prior to use.

[0057] While application of thermal energy from the therapeutic strip is described, other variations may include alternative applications of using the therapeutic strip for cooling of the underlying skin. Rather than using a heating layer 36 in an exothermic reaction, the layer may instead be configured to utilize an endothermic reaction to provide cooling of the skin, for example, at temperatures between about 0°C and 37°C, or more specifically, between about 25°C and 35°C. One example may include having a layer 36 incorporating water and ammonium nitrate or ammonium chloride. A mixture of water and ammonium may reduce the temperature of the layer 36. Another variation may include the use of a cooling gel made by adding hydroxyethyl cellulose or vinyl-coated silica gel, which may be cooled or frozen prior to use. Alternatively, cooling may be achieved by application of a cooling element such as a Peltier junction. Cooling, rather than heating, may be applied to conditions such as reducing inflammation, easing allergies or tired eyes, especially when the patient is resting or sleeping. One example would be treatment for allergic conjunctivitis, where application of cooling therapy would provide relief from any burning or itching by acting as a vasoconstrictor, restricting blood flow, decreasing vascular leakage and permeability, thereby reducing acute swelling and inflammation. Yet another example would be reducing inflammation and fibrosis of the conjunctival bleb resulting from trabeculectomy, or alleviating inflammation following any common ophthalmic surgical procedure.

[0058] Given the many different mechanisms for incorporating the heating layer 36, the treatment strips may be configured to be one-time disposable strips, multiple use disposables, reusable strips, selectively actuable, and the like.

[0059] In addition to the application of thermal energy from the therapeutic strip, the strip may also include layers for the diffusion or release of one or more pharmaceutical, biological, or chemical agents, either alone or in combination with thermal therapy. For example, pharmaceutical, biological, or chemical agents may be incorporated entirely into either the contact layer 34, the insulating layer 38, or a separate layer for transdermal delivery to the meibomian glands or areas surrounding the meibomian glands for additional and / or alternative treatments. For example, some examples of various agents that the therapeutic strip may incorporate (with or without thermal therapy) include, but are not limited to, anti-inflammatory compounds, antibiotics, topical tetracycline, oral tetracycline, topical corticosteroids, oral corticosteroids, topical androgens, metronidazole, steroid antagonists, topical androgen analogs, 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 lipid production , agents that act as secretagogues to enhance meibomian gland secretions, agents that replace or enhance the production of any tear component (cholinergic, muscarinic, or nicotinic agonists may be used), cosmeceuticals in the cosmetic field, e.g., wrinkled skin, swollen skin, These may include retinol or hyaluronic acid (HA) for sagging skin, retinoic acid for acne, or agents that break down or break down lipids such as lipase.

[0060] Other agents may include, for example, androgens such as alpha-melanocyte-stimulating hormone or adrenocorticotropic hormone or testosterone to increase tear production, agents that stimulate blinking, increase blink frequency, or stimulate underlying muscles such as the orbicularis oculi or Riolan muscle to maintain longer closure after blinking by inhibiting the levator palpebrae superioris muscle from biasing blinking or eyelid closure or otherwise mechanically compressing the meibomian or Zeiss glands or other goblet cells or accessory lacrimal glands.

[0061] Additionally and / or alternatively, other agents for incorporation into the therapeutic strip may include, for example, neurotransmitters, noxious or irritating chemicals or vapors, hormones, oils, lipids, polar lipids, or fatty acids. The use of neurotransmitters may allow stimulation to occur via second messenger pathways such as activation of the calcium / protein kinase C pathway, G-protein activation, other calcium-related pathways, calcium-calmodulin-dependent protein kinase, cyclic adenosine monophosphate-dependent pathways, adenylyl cyclase pathways, and inhibition of cAMP-dependent phosphodiesterase.

[0062] If a pharmaceutical or chemical agent is released during heat treatment, the heat may improve the penetration of any drug into the underlying skin.

[0063] Yet another variation may incorporate a treatment strip that may be applied via the treatment strip onto the upper UL and / or lower eyelid LL for treatment of the meibomian glands, apply a thermal massage, or apply a compound that attracts light and heats up accordingly. Each of these variations may allow the treatment strips 10, 12 to be applied and used while allowing for natural blinking, which helps clear dissolved oil blockages in the meibomian glands from the ducts and promotes spreading of the oil onto the tear fluid.

[0064] The treatment strips may incorporate various layers in the strip to provide a variety of different treatments, but the strips may also vary in size, shape, contour, etc., depending on the desired treatment area, so long as the treatment strip is contoured or shaped to follow the location of at least one meibomian gland. An example of another configuration for a treatment strip is shown in the front view of FIG. 4, which illustrates a contoured, thin strip 40 that is sized and shaped for placement along the upper eyelid UL. This treatment strip may have a contoured lower edge 42 as well as a contoured upper edge 44 that follows the location of the underlying meibomian glands. Additionally, although the strips 40 are shown placed on the upper eyelids UL of both eyes of patient P, a single strip 40 may be used on a single eyelid to selectively treat a particular meibomian gland in this and other examples shown herein. Additionally, one or both upper eyelids UL may be treated alone or in combination with one or both lower eyelids LL, depending on the desired treatment in this and other examples shown herein.

[0065] Another variation is shown in the front view of Figure 5, which shows a contoured thick strip 50 having a contoured lower edge 52 and a contoured upper edge 54 for placement over the meibomian glands and surrounding tissue and glands. In yet another variation, rather than utilizing two separate treatment strips, a single strip may also be used to extend across the bridge of the patient's nose. In addition, the thickened strip 50 may cover a portion of the skin proximally away from the lid margin to facilitate healing. Because the arterial blood supply to the eyelid is from proximal to distal to the lid margin, the treatment strip may heat (or cool) it as the blood supply continues to flow toward the lid margin. This initial heating (or cooling) may result in increased comfort for the patient, improved eyelid function (blinking, etc.), and reduced inflammation. This may provide a potentially more effective therapeutic effect, with less impact, increased safety of application and distance from the ocular surface, and allowing for more global heating or cooling therapy.

[0066] FIG. 6 illustrates yet another variation having a contoured thin strip 60 with lower 62 and upper 64 edges meeting at a tapered end 66 for placement over the meibomian glands. FIG. 7 illustrates yet another variation in which the treatment strip may comprise a linear strip 70 having a first width also used in combination with a thin linear strip 72. The linear strip 70 may optionally comprise a linear strip (optionally with rounded corners) that may be placed over the meibomian glands. In this embodiment, a single linear strip 70 may be applied over the upper eyelid UL of a single eye, while the remaining eyes may utilize a single linear strip 70 applied along a first portion of the upper eyelid UL and a second linear strip 72 having a relatively thinner width for placement over a second portion of the upper eyelid UL. Each strip may be applied alone or in various combinations depending on the desired treatment area, and is shown in this variation as an exemplary combination.

[0067] In the variation of FIG. 8, an example of a contoured thin strip 80 is shown applied along the lower eyelid LL. As shown, a contoured upper edge 82 and a contoured lower edge 84 may be contoured to cover and follow the underlying meibomian glands. As previously described, the treatment strips may be applied alone over one or both eyes, or in combination with treatment strips over one or both eyes of the upper eyelid. Additionally, any of the treatment strips shown herein may be used in any number of combinations with one another.

[0068] FIG. 9 shows another variation in which a contoured thick strip 90 may be applied over the lower eyelid LL and may have a relatively wider width than those treatment strips shown above in FIG. 8. Similarly, FIG. 10 shows yet another variation in which a contoured thick strip 92 may have a relatively wider width to treat not only the lower meibomian glands but also any glands and tissue surrounding the periorbital area. As previously described with respect to the variation of FIG. 5, the wider treatment strip may heat (or cool) the blood supply as it continues to flow toward the eyelid margin. The initial heating (or cooling) may provide therapeutic benefits for increased comfort to the patient, less impact on eyelid function (such as blinking), and increased safety of application and distance from the ocular surface.

[0069] Besides varying the width of the treatment strips, any of the treatment strips may be varied in length as well to selectively target a portion of the meibomian glands, or selected meibomian glands in particular. For example, FIG. 11 shows one variation in which a shortened contoured strip 100 having a first shortened length may be provided on the lower eyelid LL (and / or on the upper eyelid UL). A second contoured strip 102 having a second length longer than the shortened contoured strip 100 may also be shown for comparison. FIG. 12 similarly shows a shortened and straight strip 110 applied on the lower eyelid LL and a second straight strip 112 having a relatively longer length applied on the second lower eyelid LL. The straight strips 110, 112 may incorporate rounded ends and may be varied in length depending on the desired treatment area. They may also be rounded or circular to cover one or more styes.

[0070] 13 shows yet another variation in which the contoured strip 120 may be configured with a tapered end to cover the meibomian glands. Also shown are relatively wider, thicker contoured strips 122 to modify the treatment area.

[0071] FIG. 14 shows another variation, in which a contoured strip 130 has a first portion 131 that is relatively wider than a second portion 134 for placement over the meibomian glands of the lower eyelid LL. 2. The first 132 and second 134 portions may each be varied in width depending on the desired treatment area as well. Another example is shown in FIG. 15 showing a contoured strip 140 having a first portion 142 and a second portion 144 that are substantially wider to treat not only the meibomian glands along the lower eyelid LL, but also the surrounding periorbital tissue area such as the inferior maxillary sinus. FIG. 16 shows yet another example of a contoured strip 150 having a first portion 152 and a second portion 154 that is wider than the first portion 152, such that the strip 150 is positioned to cover not only a portion of the meibomian glands along the lower eyelid LL, but also various other glands such as the lacrimal gland around the periorbital area.

[0072] 17 illustrates yet another variation of a treatment strip, consisting of a contoured strip 160 having a secondary extension portion 162 attached via a connecting strip 164. The contoured strip 160 may treat the meibomian glands along the lower eyelid LL, while the secondary extension portion 162 may treat an area of ​​tissue along the patient's cheek.

[0073] In yet another variation, Fig. 18 shows an example in which both an upper contoured strip 170 and a lower contoured strip 172 may be applied along the upper eyelid UL and lower eyelid LL, respectively. As previously described, the contoured strips 170, 172 are shaped and applied to follow the underlying meibomian glands while allowing the patient P to blink normally. Fig. 19 shows an upper contoured strip 180 and a lower contoured strip 182 applied in a similar manner, where the strips may be varied in color to more closely match the skin tone or shade of the patient P. Because the treatment strips may be used throughout the day at any given time, the strips 180, 182 may be made in a variety of colors or shades to more closely match either the skin tone or shade of the patient P.

[0074] In yet another variation, FIG. 20 shows another embodiment in which the treatment strips may be varied in length to treat specific areas along the upper UL or lower eyelid LL. In this embodiment, a first upper strip 190 having a first length may be applied adjacent to a second upper strip 192 having a second, longer length. Optionally, a third upper strip 194 and / or a fourth upper strip 196 having relatively shorter lengths may also be applied over selected meibomian glands as well. A lower strip 198 having enlarged distal ends 200, 202 is also shown for placement along the lower eyelid LL. The distal end 200 may 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 Figure 21, which illustrates several shortened treatment strips, e.g., a first upper strip 210 and a second upper strip 212 selectively placed along the upper eyelid UL, along with a first lower strip 214 and a second lower strip 216 selectively placed along the lower eyelid LL. The strips may each be varied in length as well as size depending on the treatment area.

[0075] By varying the length of the treatment strips, multiple strips may be applied adjacent to one another or to overlap horizontally and / or vertically along the eyelid. Additionally, one or more of the treatment strips may be fabricated as a single unit or as a series of panels, oriented either horizontally or vertically, that may be connected by a flexible support, optionally. As shown in the variation of FIG. 22, targeted strips 220 each may be fabricated in length, e.g., about 1 m, to cover only a single meibomian gland. m. One or more of the targeted strips 220 may be applied along the upper eyelid UL and / or the lower eyelid LL. In addition, one or more of the targeted strips 222 may further comprise a connecting member 224 that acts as a support for interconnecting each of the individual targeted strips 222 with each other. The individual strips may be selectively applied along either the upper eyelid UL and / or the lower eyelid LL, particularly to problematic meibomian glands. For example, FIG. 23 shows a configuration of a targeted strip applied only to the lower eyelid LL. 2, individual targeted strips 222 are shown positioned along the

[0076] The therapeutic strip may be applied to one or more of the meibomian glands, although variations of the strip may also be used to treat other glands, such as sebaceous glands, for example, for acne treatment. Therapeutic strips used to treat acne may utilize different pharmacological treatments. Other glands in the lower eyelid and conjunctival CN for treatment may also include, for example, Zeiss glands GZ, goblet cells, accessory sebaceous glands, accessory goblet cells, such as Henle's and Manz's glands, accessory lacrimal Wolfring glands GW or Krause's GK, or treatment of either one or both lobes of the main lacrimal gland, such as the palpebral or orbital portions.

[0077] Additionally, the therapeutic strips may potentially be used to treat eye disorders other than meibomian gland dysfunction, including, for example, blepharitis, Sjogren's syndrome, dacryoadenitis, conjunctivitis, allergic conjunctivitis, keratoconjunctivitis sicca, keratitis, dacryocystitis, iritis, keratitis, retinitis, sclerokeratitis, uveitis, contact lens related eye problems, after blepharoplasty or eyelid or eye surgical procedures (e.g., cataract surgery, LASIK, PRK, etc.), blinking deficit or dysfunction disorders, conjunctivitis, blepharospasm, exposure keratopathy, lagophthalmos, orbicularis oculi flicker, infections, styes, chalazions, styes, glaucoma, blisters, trauma, and the like.

[0078] Yet another embodiment may include the use of therapeutic strips to treat disorders of the lacrimal gland LG and / or palpebral lacrimal gland PL, located above the eye, as previously described and shown in FIG. 24. Variously sized therapeutic strips, such as the lacrimal gland strip 230 shown in FIG. 25, sized to have a curved upper periphery, may be sized for placement directly over the skin surface above where the lacrimal gland LG is located. Other variations are shown in FIG. 26, illustrating a lacrimal gland strip 232 that is relatively thinner in width, and FIG. 27, illustrating a lacrimal gland strip 234 that has a curved periphery that terminates in a tapered end. The therapeutic strips may deliver heat, for example, to stimulate the lacrimal gland LG, increasing gland metabolism, activity, tearing, etc. Alternatively, the therapeutic strips may deliver cold therapy to reduce inflammation that impairs gland function.

[0079] The lacrimal gland LG and / or the palpebral lacrimal gland PL may be treated alone or in combination with a contoured treatment strip for treatment of the meibomian glands. One variation is shown in FIG. 28, which illustrates a contoured strip 240 that has been expanded in width to cover both the lacrimal gland LG as well as the meibomian glands along the upper eyelid UL. A contoured treatment strip 242 is also shown positioned along the lower eyelid LL for treatment of the meibomian glands as well.

[0080] Fig. 29 shows another variation in which a lacrimal gland strip 250 may be placed over the lacrimal gland LG in combination with a one-piece, combined, contoured strip 252 that is sized to completely encircle the eye while following the location of the meibomian gland along both the upper eyelid UL and the lower eyelid LL. Such a completely encircling design may also be held in place more tightly against the skin by a strap that may encircle the patient's head, if desired. Another variation is shown in Fig. 30, which illustrates a one-piece, combined, contoured strip 260 that is also sized to completely encircle the eye and have a suitable width for placement over the lacrimal gland LG.

[0081] The lacrimal gland strip 270 may be used in combination with any of the therapeutic strips shown herein. Another embodiment is illustrated in Fig. 31, which shows the lacrimal gland strip 270 used in combination with individual strips 222, while Fig. 32 further illustrates another embodiment in which the lacrimal gland strip 270 may be used in combination with not only individual strips 222, but also strips 220 located along the individual lower eyelids LL and upper eyelids UL.

[0082] The treatment strip may be applied over the meibomian glands and apply thermal energy, but the treatment does not require the application of any external force applied by the strip or any other external device, and may utilize the patient's natural blinking to facilitate the treatment, as previously described. However, in additional variations, the treatment strip may be configured to apply both thermal therapy as well as an external force. Any number of mechanisms may be utilized to apply a clamping or biasing force and provide compression of the underlying skin and meibomian glands during application of thermal therapy. One embodiment is shown in the front view of FIG. 33, which illustrates a biased treatment strip 280, which may consist of a strip 282, with one or more biasing mechanisms 284 positioned along the strip 282, as previously described. One or more biasing mechanisms 284 may be positioned along either or both of the upper or lower strips, as shown.

[0083] In this embodiment, the biasing mechanism 284 locally squeezes or compresses the underlying skin, applying pressure to the glands MG and may facilitate the removal of any obstructions, especially if applied simultaneously with heat therapy. An example of the biasing mechanism 284 is illustrated in the perspective view of FIG. 34, which shows how the biasing mechanism 284 may comprise a portion or separate member of the strip 282 that is biased to form corresponding channels 286 configured to generally flex into an open or closed configuration. When the strip is initially placed on the skin, an end of the strip may be pulled to open the channels 286 and then placed on the skin surface. As the strip and biasing mechanism 284 relax, the underlying skin and glands MG may be squeezed or pinched by a squeezing force 288 induced by the biasing mechanism 284.

[0084] Besides compressive force, the strips may be formed with alternative components, such as mechanical components, to impart vibrational energy, promote meibomian gland expression, and reduce oil secretion. An example is illustrated in FIG. 35, which shows another variation of contoured strips 290A, 290B having one or more vibrational elements 292 (e.g., piezoelectric transducers, electromagnetic actuators, eccentrically coupled rotating elements, etc.) incorporated along the strips 290A, 290B. The one or more vibrational elements 292 may be electrically coupled to a power source and / or processor 294, which may also be included along the strips 290A, 290B. Additionally, vibrational energy may be applied separately from or in combination with heat therapy. The power source may include a microbattery that is rechargeable and capable of delivering a microcurrent of energy.

[0085] Besides the application of mechanical pressure or vibrational energy, other forms of energy may also be delivered by one or more of the treatment strips. Another variation is illustrated in FIG. 36, which shows an upper contoured strip 300A having conductive elements 302, such as wires, integrated along the entire length (or partial length) of the contoured strip 300A. The conductive elements 302 may be configured in an alternating pattern or simply aligned along the length of the strip, as illustrated by the conductive elements 306 (or electrical resistivity) along the lower contoured strip 300B. The conductive elements 302, 306 may each be in electrical communication with a separate power supply and / or processor 304, 308. The conductive elements 302, 306 may be activated to selectively apply thermal energy or may be configured to apply radio frequency (RF) energy to the underlying skin and meibomian glands. With regard to the application of electrical energy, the electrical energy that may be applied by the treatment strips may be: One form of energy may include, for example, the use of transepidermal electrical nerve stimulation features to deliver nerve stimulation to increase tear production. The conductive elements may generate thermal energy via various power sources, such as batteries, solar cells, kinetic transfer, RF, etc.

[0086] FIG. 37 illustrates yet another variation in which contoured strips 310A, 310B may be coupled to a power source and, for example, to apply microwave energy to the underlying meibomian glands. The strip may be configured to incorporate electrodes or antennas 312 coupled to a suction cup 316 and / or a processor 314. Besides electrical or microwave energy, the treatment strip may be configured to apply still other forms of energy to treat the meibomian glands. For example, other variations may incorporate actuators or transmitters to apply ultrasound, RF, microwave, magnetic, photon (light energy in the infrared or visible light spectrum), etc. In still other variations, the conductive element may be configured to function as an electromagnetic element once actuated, or the strip may incorporate a ferromagnetic element to aid in closure of the eyelids. The magnetic force may serve to squeeze the meibomian glands and squeeze out oily obstructions as the eye overcomes the magnetic force and opens and reopens.

[0087] In yet another variation, one or both therapeutic strips 320A, 320B may incorporate an indicator 324, e.g., an LED light, an alarm, a vibrating element, etc., electrically coupled to the power supply and / or processor 322, and configured to alert the patient that the prescribed treatment has been completed. This feature (and any other feature) may be combined, where practicable, with any of the other therapeutic strip variations described herein.

[0088] 39 shows yet another variation, where the eyelid treatment system 330 may be formed into an interlocking dual strip design, e.g., a "furcula-like" design, where the dual strip heating strip may have two heating elements that follow the location of the meibomian glands of the upper UL and lower LL eyelids of a single eye. Depending on whether both eyes or a single eye and / or both upper and lower eyelids are to be treated, the system 330 may include a first heating strip assembly 332 and a second heating strip assembly 334 for each individual eye. The assemblies 332, 334 may each utilize upper and lower eyelid treatment heaters, e.g., upper eyelid treatment strip 332A and lower eyelid treatment strip 332B, as appropriate, and the upper and lower elements may each be interconnected via wire 336. Additionally, assemblies 332, 334 may each be coupled to a portable electronic device 342 (e.g., a smart phone with a touch screen interface, a tablet, a PDA, a laptop computer, etc.) via a connecting cable 338 as shown (e.g., through an input / output port such as a headphone jack, a USB port, or other connection port) and to a controller 340.

[0089] In other variations, the number of connecting cables may range from one to four connector cables rather than utilizing a single cable 338. For example, one cable may be used to provide power and communications to some or all of the four heating elements in each of the assemblies 332, 334. Alternatively, four connecting cables may provide power and communications to each of the heating elements in the assemblies 332, 334. Additionally, in another alternative, two connecting cables may provide power and communications to each of the assemblies 332, 334.

[0090] In other additional variations, any of the described therapeutic strips may be used in combination with the controller 342 described herein, where practicable. In yet further variations, an oval or circular shaped heating element may cover the eye and both eyelids. Alternatively, the heating element or strip may be oriented in a circular, circular, or oval shape, in which case the outer boundary of the heating element or strip may follow the path of the upper and lower meibomian glands. In this case, one treatment strip may cover both eyelids and both sets of meibomian glands, and the user may use a total of two (rather than four) round, circular, or oval shaped treatment strips to cover both eyes. Such variations may be used, for example, during nighttime therapy in bed before or during sleep, where the eyes do not necessarily need to be open.

[0091] The assemblies 332, 334 generally follow the location of the meibomian glands, as previously described. While still providing a strip that allows the patient to blink easily and comfortably perform daily activities. Examples of such heaters that may be configured for use with treatment system 330 may include thin, flexible heaters that are commercially available from companies such as Minco Product, Inc. (Minneapolis, MN) or can be custom designed and manufactured independently or through a third party manufacturer. Each individual treatment strip, e.g., treatment strips 332A, 332B, may each be sized for a single eyelid, e.g., 28 mm x 7 mm x 0.15 mm, with a basal chord length, e.g., 28 mm, a radius of curvature, e.g., 75 mm, and the general configuration of an arced rectangle with an obtuse angle where the nasal or temporal edge may match the radius of the arc. However, these size limitations are intended to be exemplary and not limiting, as the therapeutic strips 332A, 332B may be sized smaller or larger to accommodate different ocular anatomies.

[0092] Additionally, individual treatment strips 332A, 332B may be formed as thin, flexible, transparent polymers containing the heating elements while the contact surfaces of the strips may be affixed to the individual eyelids, for example, with a disposable adhesive. Other variations may utilize opaque or colored strips, for example skin tones. Additionally, one or more temperature sensors may also be incorporated into the treatment strips, in which case the heating elements and sensors may be routed to a power source and / or controller 340 and / or portable electronic device 342 through a connecting cable 338, as shown.

[0093] The controller 340 may generally comprise a hardware / software platform or unit that may be programmed to control a therapy treatment. Thus, the controller 340 may include a processor and a power supply, such as a battery (rechargeable or disposable), for providing power to the assemblies 332, 334. The power supply within the controller 340 may optionally be rechargeable separately from the portable electronic device 342, or the power supply may similarly draw power for the assemblies 332, 334 and processor directly from the portable electronic device 342.

[0094] If the controller 340 is programmed to provide a therapy treatment protocol, one or more controls for controlling the treatment may be built directly into the controller 340. The portable electronic device 342 may interface with the controller 340 and display some of the controls on a display, in one variation, a screen (e.g., a touch screen) of the electronic device 342, such as controls for starting and / or stopping the treatment. Alternatively, all of the controls may reside on the controller 340, while the display on the electronic device 342 may serve primarily to show or track various results or treatment parameters.

[0095] In yet another alternative, all of the controls may reside not on the controller 340, but on the display of the electronic device 342 for controlling the various treatment options and parameters. In this variation, the electronic device 342 (in this example, a smartphone) also has a built-in The electronic device 342 may provide a force to the therapy strip assemblies 332, 334, control various therapy temperatures and times, and provide temperature feedback or other physiological parameters that may be measured. In this case, the therapy strips 332, 334 and connecting cable 338 may be plugged directly into a mobile or portable consumer electronic device 342. For example, the electronic device 342 may be used to display therapy parameters and controls, such as an icon or button to initiate therapy. In one embodiment, therapy may be initiated by a user through the electronic device 342, heating one or more of the strips of one or both of the therapy strip assemblies 332, 334. In any of the variations, the electronic device 342 (particularly in the case of a smartphone or tablet) may be an electronic The device 342 may have optional programs or applications downloaded onto it that facilitate various control and / or display parameters on the electronic device 342 depending on how it is used in conjunction with the controller 340 and assemblies 332, 334.

[0096] In addition, the electronic device 342 may also provide diagnostic features to allow the user to test for dry eye and / or determine how well the treatment has progressed, either before, during, or after treatment. Thus, the electronic device 342 or controller 340 may utilize, for example, an integrated camera and / or flash / light source for purposes of photographing the user's ocular tear film or ocular surface and evaluating commonly used tear assessment criteria, such as overall tear film layer thickness, and / or tear film mucin layer thickness, and / or tear film lipid layer thickness, and / or tear film aqueous layer thickness, or any combination thereof. In addition to photographing the user's tear film and / or ocular surface condition, the mobile application may include other common methods for diagnosing dry eye, such as asking the user questions related to the user's symptoms, discomfort, and / or symptom improvement or worsening, which may be completed using the electronic device's touchscreen interface, and the results may be stored on the electronic device 342 or web application or manufacturer's server and tracked over time for trend evaluation and potentially shared with the user's physician.

[0097] Further, in any of the variations, the controller 340 and / or electronic device 342 may be programmed or initiated to heat the assemblies 332, 334 to, for example, 42.5° C. + / - 1° C. to 2° C. The treatment time may be set, for example, to 15 to 30 minutes, and the controller 340 and / or electronic device 342 may be further programmed to stop once the allotted treatment time has elapsed or if the measured temperature rises above a predetermined level, for example, 45° C. In addition, the controller 340 and / or electronic device 342 may also be programmed or configured to indicate various treatment parameters (e.g., start of treatment, heating element warming, completion of treatment, error, battery life, etc.) through any number of visual, audio, or tactile indicators.

[0098] Additionally, the controller 340 and / or electronic device 342 may be used to store and / or transmit various data, such as historical treatment data, usage time, total treatment time, temperature data, etc. Furthermore, the controller 340 and / or electronic device 342 may wirelessly communicate with a remote server or additional controllers, allowing the controller 340 and / or electronic device 342 to also be remotely programmed, for example, by a physician or other party. In yet other variations, audio and / or visual information (e.g., advertising or other media) that may be received from a remote server may also be displayed on the controller 340 and / or electronic device 342, or various other data may be transmitted to and / or from the controller 340 and / or electronic device 342 as well.

[0099] In yet other variations, the controller 340 is shown coupled to the assemblies 332, 334 via a wired connection cable 338, although other variations may have the controller 340 wirelessly connected to the assemblies 332, 334. Such connection may be through any number of wireless protocols, such as Bluetooth, RF, etc.

[0100] This "precise temperature controlled" mobile heat therapy system may be used to heat other parts of the body as well; the system would remain largely the same, but the heating element dimensions may be varied and power requirements would also be altered depending on the total surface area being treated and the temperature goal. This may also be the case.

[0101] With the incorporation of a processor into the therapeutic strip, other parameters such as treatment time or temperature of the strip may be programmed and selectively turned on or off at will, by the patient or automatically. Additionally, other parameters such as frequency of heat delivery or other stimulation may also be programmed by the processor to provide further flexibility in the treatment.

[0102] The applications of the aforementioned devices and methods are not limited to the treatment of dry eye syndrome, but may include any number of additional therapeutic applications. Furthermore, such devices and methods may be applied to other treatment sites in the body where acute or chronic inflammation results in a disease or condition. The therapeutic strips can be custom designed to follow the pathways of the underlying physiology as appropriate, such as cooling or heating therapeutic strips that are custom designed and contoured to treat sinusitis, acute or chronic sinusitis, rhinitis and allergic rhinitis, joint pain and inflammation, arthritis, muscle pain, back pain, headaches, wounds, sports injuries, and the like. Modifications of the aforementioned assemblies and methods for carrying out the invention, combinations between different variations, where 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.

Claims

[Claim 1] 1. A therapeutic assembly comprising: The device is configured to adhere to an area under the skin of an upper eyelid of a subject, the area being free of restriction from the upper strip. The upper strip constituting the treatment assembly to enable natural blinking in the blink of an eye. an upper curvature configured to extend and follow the upper edge of the meibomian gland of the upper eyelid; a curved or arcuate periphery and an outer boundary of the upper strip is encompassed by the lower tarsal plate; and a lower periphery configured to extend and follow along the free edge of the upper eyelid. The upper strip, a controller in communication with the upper strip, the controller controlling the treatment assembly; The present invention relates to a method for controlling one or more parameters of yellowtail, including at least one thermal parameter. a controller programmed to Equipped with said upper strip having a thickness of 0.125 inches or less; The upper strip is configured to be in thermal communication with the subcutaneous area, and the subject is a heating element configured to emit thermal energy to the under-skin region without interfering with the blinking of the eye; [0023] The present invention further includes a mechanism, The heating mechanism is configured such that at least a portion of the heating mechanism is located at the upper edge of the meibomian gland of the upper eyelid. a treatment strip extending substantially the entire length of the upper strip so as to be adapted to follow the treatment strip; For assembly.

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