Dry Eye Treatment System

Abstract

The present application relates to a dry eye treatment system. Dry eye treatment devices and methods are described herein, which generally include a patch or strip that is affixed to the skin of the upper and / or lower eyelid to deliver heat or other forms of energy, pressure, medication, moisture, etc. (alone or in combination) to one or more meibomian glands contained within the underlying skin. The treatment strip includes one or more strips configured to be attached to an area of skin beneath one or both eyes of a subject adjacent to the subject, such that the one or more strips allow the subject to blink naturally without being constrained by the one or more patches. In addition, the one or more strips can be configured to emit energy to the underlying skin area and wherein the one or more strips are shaped to conform to the position of one or more meibomian glands contained within the underlying skin area.

Description

[0001] This application is a divisional application of an application filed on October 9, 2012, with application number 201710769358.4 and invention name “Dry Eye Treatment System”.

[0002] The application with the application date of October 9, 2012, application number 201710769358.4, and invention name “Dry Eye Treatment System” is a divisional application of the application with the application date of October 9, 2012, application number 201280071161.9, and invention name “Dry Eye Treatment System”.

[0003] CROSS-REFERENCE TO RELATED APPLICATIONS

[0004] This is a continuation-in-part of U.S. patent application Ser. No. 13 / 343,407, filed Jan. 4, 2012, and U.S. patent application Ser. No. 13 / 645,985, filed Oct. 5, 2012, the contents of which are incorporated herein by reference in their entireties. Technical Field

[0005] The present invention relates to methods and apparatus for treating dry eye syndrome and other related conditions. More particularly, the present invention relates to methods and apparatus for treating dry eye syndrome using adhesive strips that are specifically contoured or shaped to adhere to selected areas around a patient's eye or periorbital area. Background Art

[0006] Tears are a complex mixture of water, lipids, mucus, proteins, and electrolytes and this mixture helps maintain a smooth and clear optical surface and also helps protect the eye from infection. The tear film has three basic layers: oil, water, and mucus and problems or disturbances in any of these layers can lead to dry eye symptoms.

[0007] The outermost layer of the tear film typically includes an oily layer (grease layer) containing fatty acids and lipids, which are mainly produced by the sebaceous glands called meibomian glands located along the edge of the eyelid. The oily layer makes the tear surface smooth and slows down the evaporation of the aqueous middle layer. However, if the meibomian glands are unable to produce enough oil, a suboptimal fatty acid mixture is produced, or if the glands are blocked or clogged, the aqueous layer typically evaporates too rapidly, causing dry eyes. The obstruction of the meibomian glands can cause glandular enlargement or infection. Therefore, dry eyes are common in people whose meibomian glands are blocked or inappropriately function.

[0008] The middle layer of tears is primarily composed of an aqueous solution produced by the lacrimal glands (tear glands). The middle layer cleanses the eye and washes away foreign particles or irritants, maintaining optical clarity and keeping the ocular surface moist. The innermost layer of the tear film is primarily composed of mucus, which helps distribute the tears evenly over the surface of the eye. A lack of mucus in the tear film is also associated with dry eye syndrome.

[0009] As discussed above, the meibomian glands are oil-secreting glands located in both the upper and lower eyelids. There are approximately 30 to 40 glands along the upper eyelid and approximately 20 to 30 glands along the lower eyelid, with the ducts in each gland opened by small holes along the inner edge of the free edge of the respective eyelid through which their secretions are released to prevent the eyelids from adhering to each other. An example of the location of the meibomian glands is in Figure 1A , which illustrates the relative positioning of a single meibomian gland MG. Other glands and anatomical features are illustrated for reference, such as the following glands: Wolfring GW, tarsal plate TR, Melson's gland GM, palpebral gland GZ, Kraus' gland GK, superior fornix UF, conjunctiva CN, and cornea CR of the eye partially covered by the upper eyelid UL. As shown, the meibomian gland MG is located along the length of the upper eyelid UL (and lower eyelid LL), with the duct opening along the inner edge of the eyelid UL adjacent to the underlying ocular surface.

[0010] Figure 1B Illustrated is 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 is blinking. As shown, the meibomian glands MG can be seen aligned adjacent to each other on both the upper eyelid UL and the lower eyelid LL. Figure 1C Also shown is a perspective view of the patient's eye in an open position to illustrate how the meibomian glands are typically aligned relative to each other when the patient's eye is opened.

[0011] Blinking is believed to be the primary mechanism for opening the pores of the meibomian glands to allow the release of oil secretions from the glands. The natural blinking motion and force of blinking causes the upper eyelid to pull the lipid sheet secreted by the meibomian glands across the two underlying layers of the tear film, forming a protective coating that limits the evaporation rate of the underlying layers. It is estimated that approximately 65% of meibomian gland diseases or dry eye result from a defective lipid layer or an insufficient amount of such lipids that causes accelerated evaporation of the aqueous layer. Therefore, blinking disorders or other disorders that affect proper tear distribution can cause or worsen meibomian gland dysfunction or dry eye.

[0012] When the eyelids close in a full blink, the upper and lower fornixes, which hold the tears, are compressed by the force of the sensory muscles, and the eyelids move toward each other. For example, the upper eyelid moves across the eye, exerting force on the surface of the eye, which helps clear debris and insoluble mucin from the front of the eye and also promotes oil secretion from the meibomian glands. The lower eyelid moves horizontally toward the nose and pushes debris toward the two puncta, which ultimately drain into the openings of the nasal cavity.

[0013] When the eyelids open, the tear film is redistributed, with the upper eyelid extracting the aqueous phase by capillary action and the lipid layer being dispersed as rapidly as possible upon eyelid movement. Eyelid movement is therefore important in tear film renewal, distribution, turnover, and drainage.

[0014] Meibomian glands can become blocked, clogged, or obstructed for a variety of reasons, leading to meibomian gland dysfunction and dry eye disease. The obstruction that triggers the disease can be located anywhere within the meibomian gland, such as on the surface or pore of the gland, preventing normal flow of lipid secretions; in the main passage of the gland, which can be narrowed or blocked; or at other deeper locations within the gland that lead to the main passage.

[0015] Treatment for blocked meibomian glands can include a variety of conventional treatments. One course of treatment includes soap and detergents, eyelid scrubs, or the application of antibiotics to reduce eyelid inflammation. Antibiotics such as tetracycline, doxycycline, metronidazole, or erythromycin can be taken orally or topically to help regulate or improve meibomian gland lipid production. Inflammation on the surface of the eye can also be treated with topical medications such as corticosteroids or cyclosporine ( Allergan, Inc., California) or other anti-inflammatory compounds or immunosuppressants are administered. Evidence suggests that ocular surface inflammation is associated not only with meibomian gland dysfunction but also with dry eye syndrome.

[0016] Other examples of dry eye treatment may include the application of prescription ocular inserts to people with moderate to severe dry eye symptoms who are unable to use artificial tears. Ocular inserts such as hydroxypropylcellulose ( Merck & Co., Inc., New Jersey) can be inserted between the lower eyelid and the eye. The insert slowly dissolves to release a substance that lubricates the eye. Alternatively, a specialized contact lens can be used to protect the surface of the eye to trap moisture.

[0017] In other treatments, the patient's tear ducts can be closed through procedures such as the insertion of punctal plugs into the tear ducts or cauterization of the tissue in the drainage area to prevent the tear film from draining away too quickly from the surface of the eye. In addition to implants or cauterization treatments, dry eye syndrome can be treated with pharmaceutical agents such as eye drops, ointments applied to the eye, etc. Artificial tears, gels, ointments, autologous serum tears, or albumin drops have all been used in the treatment of dry eye.

[0018] Additionally, warm compresses are typically placed on the eye and used to restore meibomian gland function by melting any lipid blockages, combined with eyelid massage, which can further express the gland's contents. However, the application of warm compresses requires them to be applied two to three times daily, during which time the patient may not be able to properly target only one affected eyelid and because the compresses are also prevented from looking out of the treated eye. The compresses can be too hot, further exacerbating inflammation, or they can cool too quickly, preventing adequate therapeutic effect.

[0019] Other treatment devices have also been developed that cover the entire affected eye to apply heat and massaging forces directly to the affected eyelid. However, such devices, such as compression devices, require the patient's eye to be temporarily but completely blocked during treatment, resulting in discomfort, loss of productivity, and potentially reduced compliance among patients. Furthermore, these treatments require a visit to a physician or care provider and are not well-suited for widespread consumer adoption. Summary of the Invention

[0020] Accordingly, a need exists for methods and devices that are relatively simple for patients to use on a daily basis, yet allow patients to continue their normal activities, are non-obtrusive and non-disruptive, and yet utilize the patient's natural physiological activities to assist in treatment.

[0021] 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 eyelids to deliver heat or other forms of energy, pressure, medication, moisture, etc. (alone or in combination) to one or more meibomian glands contained within the underlying skin. In particular, the components for the one or more treatment strips can generally include one or more strips configured to attach to an underlying region of skin adjacent one or both eyes of a subject such that the one or more strips allow the subject to blink naturally without being constrained by the one or more patches. Furthermore, the one or more strips can be configured to emit energy to the underlying skin region and wherein the one or more strips are shaped to conform to the position of one or more meibomian glands contained within the underlying skin region.

[0022] In use, the one or more strips can be attached to an area of skin adjacent to one or both eyes of a subject such that the one or more strips allow the subject to blink naturally without being constrained by the one or more patches. While attached, the strips can emit energy to the skin area, wherein the one or more strips are shaped to conform to the position of one or more meibomian glands contained within the skin area. Optionally, while the strips may not directly cover the meibomian glands or other ocular or orbital glands, they can deliver energy or absorb energy from the adjacent vascular system below that ultimately supplies the glands. In other words, using these strips to heat or cool the blood supply to the eyelids, meibomian glands and / or lacrimal glands can affect their function and metabolism without necessarily needing to directly cover them in a particular variation.

[0023] The upper band can thus have an upper curved or arcuate periphery shaped to extend and follow the upper (or superior) border of the meibomian glands (e.g., along or up to the crease of the upper eyelid), and the straight periphery of the lower edge can be shaped to extend and follow the lower (or inferior) border of the meibomian glands, e.g., along the free edge of the upper eyelid. Although straight, the lower edge can be gently curved or arcuate in an alternative variation. The lower band can similarly have an upper straight periphery to extend and follow the upper (or superior) border of the meibomian glands along the free edge of the lower eyelid, and a lower curved or arcuate periphery to extend and follow the lower (or inferior) border of the meibomian glands along the lower eyelid (e.g., along or up to the crease of the lower eyelid). Alternatively, the upper periphery of the lower band can also be gently curved or arcuate in an alternative variation.

[0024] In other words, with the tarsal plate containing the meibomian glands spanning from proximal to distal, the peripheral edge of the treatment strip can correspond to the distal eyelid margin and the proximal peripheral edge, and the treatment strip can adopt a variety of configurations. Generally, the peripheral distal edge of the treatment strip can be relatively straight or adopt a gentle curve, either of which can conform to the underlying distal eyelid margin and tarsal plate, while having a proximal peripheral edge that is relatively curved to conform to the more curved proximal edge of the underlying tarsal plate.

[0025] The strips can be used individually to be placed only on the upper eyelid or only on the lower eyelid, depending on the desired treatment. Furthermore, the length of the treatment strips can be varied to provide targeted treatment to individual meibomian glands, if desired, as described in greater detail herein. Furthermore, while the treatment strips can be generally sized, they can also be customized or sized for a specific individual's eyelid size.

[0026] Because of the specific contoured size and flexibility of the treatment strip, the treatment strip can be placed on the patient to apply therapy to the underlying meibomian glands, allowing the patient's eyes to be opened and closed normally without interference from one or both treatment strips. Accordingly, the contoured size, shape, and flexibility of the treatment strip allow treatment to occur and also allow the patient to keep one or both eyes open so that normal physiological blinking can occur during the course of treatment. Instead of relying on the application of any type of external force, the treatment strip utilizes the eye's natural mechanism to clear oil from the meibomian glands through blinking. Thus, the treatment strip can be attached in position for treatment without any further intervention by the patient or care provider, such that the treatment strip can apply, for example, thermal energy to melt or liquefy any waxy or solid meibomian gland obstructions while the eyes remain unobstructed and are allowed to blink naturally. The treatment strip thus allows the natural force of blinking to clear the heat-treated softened obstruction from the gland before the heat-treated softened obstruction has resolidified, unlike other treatments that require the patient to keep their eyes closed or obstructed during the course of treatment and prevent or inhibit the patient from blinking.

[0027] The treatment belt can be configured to have a contact layer (e.g., made of a conductive material such as metal, alloy, porous ceramic, engineered ceramic, wood, polymer, composite material, foam, polymer foam, fabric, elastomer, etc.) that can protect the skin from burns or any other adverse effects. A second heating layer can be positioned above the contact layer (or in direct contact with the skin) to generate thermal energy and an insulating layer can be positioned on top of the heating layer to concentrate, direct, or reflect the heat toward the underlying skin surface and to protect the patient from contact with the heating layer from other parts of the body. The insulating layer can accordingly be made of a variety of insulating materials, such as foam, foam tape, gauze, silicone, microporous polyethylene film, fabric, polymer, etc.

[0028] While the application of thermal energy from the treatment strip is described, other variations may alternatively include using the treatment strip to cool the underlying skin. Instead of using an exothermic heating layer, the layer may be configured to utilize an endothermic reaction to provide cooling of the skin. Cooling, rather than heating, can be applied for conditions such as reducing inflammation, allergies, or eye strain, particularly while the patient is resting or sleeping.

[0029] In addition to the application of thermal energy from the treatment strip, the strip can also include a layer for diffusion or release of one or more pharmaceutical, biological, or chemical agents, either alone or in combination with thermal treatment. For example, a pharmaceutical, biological, or chemical agent can be incorporated into the contact layer, the thermal insulation layer, or entirely in a separate layer for transdermal delivery to the meibomian glands or the area surrounding the meibomian glands (for additional and / or alternative treatment). In the event that a pharmacological or chemical agent is released during thermal treatment, the heat can help improve any penetration of the drug into the underlying skin.

[0030] While the treatment strips can incorporate various layers into the strip to produce a variety of different treatments, the strips can also vary in size, shape, contour, etc., depending on the desired treatment area, so long as the treatment strip is contoured or shaped to conform to the location of at least one meibomian gland.

[0031] While the therapeutic strip can be applied to one or more of the meibomian glands, variations of the strip can also be used to treat other glands, such as the sebaceous glands, for example, for acne treatment. Therapeutic strips used to treat acne can utilize different pharmacological therapies. Furthermore, the therapeutic strip can potentially be used to treat eye conditions other than meibomian gland dysfunction.

[0032] Yet another embodiment may include the use of a therapeutic strip positioned above the eye for treating conditions of the tear glands and / or eyelid tear glands. Various sized therapeutic strips, such as a tear gland strip sized to have a curved upper periphery, may be sized for placement directly on the skin surface overlying the tear glands. The tear glands and / or eyelid tear glands may be treated individually or in combination using a contoured therapeutic strip for meibomian gland treatment.

[0033] While the treatment strip can be applied to the meibomian glands to apply thermal energy, the treatment does not require the application of any external force, either by the strip or any other external device, but rather can utilize the patient's natural blinking to facilitate treatment. However, in other variations, the treatment strip can be configured to apply both thermal treatment and external force. Any number of mechanisms can be used to apply a pinching or biasing force to provide compression of the underlying skin and the meibomian glands during application of thermal therapy.

[0034] In addition to compression, the ribbon may be formed with optional components such as mechanical components to impart vibrational energy or other forms of energy to assist in the expression of the meibomian glands and promote oil secretion.

[0035] In yet another variation, one or both therapy ribbons may be configured to incorporate an indicator electrically coupled to a power source and / or processor, such as an LED light, an alarm, a vibrating element, etc., to alert the patient when the prescribed treatment is complete. This feature (and any of the other features) may be combined with any of the other variations of therapy ribbons described herein, as practicable.

[0036] Where a processor is incorporated into the treatment ribbon, treatment time or other parameters such as the temperature of the ribbon can be programmed and selectively activated or deactivated, either by the patient or automatically. Furthermore, other parameters such as the frequency of heat delivery or other stimulation can also be programmed by the processor to provide additional flexibility in treatment.

[0037] This application also covers the following aspects:

[0038] 1) A therapeutic component for dry eye syndrome, comprising:

[0039] one or more strips configured to be attached to an area of skin beneath one or both eyes of a subject such that the one or more strips allow the subject to blink naturally without being constrained by the one or more strips,

[0040] wherein the one or more strips are configured to transmit energy to the underlying skin area, and

[0041] The strip is shaped to conform to the location of one or more meibomian glands contained within the underlying skin region.

[0042] 2) The component according to 1), wherein the energy comprises thermal energy.

[0043] 3) The assembly of 1), wherein the one or more strips comprise a contact surface for placement against the skin area.

[0044] 4) The assembly of 1) wherein the one or more strips comprise a heating layer in thermal communication with the skin area.

[0045] 5) The assembly according to 4), further comprising a thermochromic layer in thermal communication with the heating layer.

[0046] 6) The assembly according to 4), wherein the heating layer is configured to generate heat in a temperature range of about 20°C to 55°C.

[0047] 7) The assembly of 4), wherein the heating layer is configured to generate heat for a period of about 5 minutes to 24 hours.

[0048] 8) The assembly of 1) wherein the one or more strips comprise a cooling layer in thermal communication with the skin area.

[0049] 9) The assembly according to 8), wherein the cooling layer is configured to reduce the temperature to a range of approximately 0°C to 37°C.

[0050] 10) The component according to 8), wherein the cooling layer comprises a hydrogel layer.

[0051] 11) The assembly of 1), wherein the one or more strips comprise an insulating layer.

[0052] 12) The assembly of claim 1), wherein the one or more strips each have a first curved or arcuate periphery and a second straight periphery, wherein the first curved or arcuate periphery is shaped to extend and conform to the boundaries of one or more meibomian glands and the second straight periphery is shaped to extend and conform to the free edge of the upper or lower eyelid.

[0053] 13) The assembly of 1), wherein the one or more ribbons each have a length ranging from about 1 mm to 50 mm.

[0054] 14) The assembly of 1), wherein the one or more strips each have a width ranging from about 1 mm to 25 mm.

[0055] 15) The assembly of 1) further comprising a controller attached to the one or more straps.

[0056] 16) The assembly of 15) wherein the controller is programmed to control one or more parameters of the one or more ribbons.

[0057] 17) The assembly according to 16), wherein the one or more parameters include temperature, treatment time, treatment frequency or thermal profile of the one or more strips.

[0058] 18) The assembly of 1) further comprising one or more additional ribbons configured to be attached to a second skin area adjacent to the subject's lacrimal gland.

[0059] 19) The assembly of 1) further comprising one or more biasing mechanisms positioned along the one or more strips, wherein the one or more biasing mechanisms are configured to apply pressure to the underlying skin area.

[0060] 20) The assembly of 1) further comprising one or more actuators positioned along the one or more strips, wherein the one or more actuators are configured to impart mechanical vibrations to the underlying skin area.

[0061] 21) The assembly according to 1) further comprises a conductive element or a resistive element positioned along the one or more strips.

[0062] 22) The component according to 21), wherein the conductive element comprises an electrode.

[0063] 23) The assembly of 21) wherein the conductive element comprises a microwave antenna.

[0064] 24) The assembly of 1) further comprising an indicator positioned along the one or more strips.

[0065] 25) The assembly according to 24), wherein the indicator comprises an audible or visual alarm for alerting the subject.

[0066] 26) The assembly according to 1) further includes one or more pharmaceutical, biological or chemical agents injected into or along the one or more strips.

[0067] 27) The assembly according to 1) further includes a power supply positioned along the one or more strips.

[0068] 28) A component according to 27), wherein the power source is rechargeable.

[0069] 29) A method for treating dry eye syndrome, comprising:

[0070] attaching one or more strips to an area of skin adjacent one or both eyes of the subject such that the one or more strips allow the subject to blink naturally without being constrained by the one or more strips; and,

[0071] emitting energy from the one or more strips to the skin area,

[0072] The one or more strips are shaped to conform to the location of one or more meibomian glands contained within the skin region.

[0073] 30) The method of claim 29), wherein attaching comprises positioning the one or more strips adjacent to one or both eyes such that a first curved or arcuate periphery of the one or more strips extends and follows the border of 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.

[0074] 31) The method according to 29), wherein attaching comprises placing the contact surface of the one or more strips against the skin area.

[0075] 32) The method of 29) wherein emitting energy comprises applying heat energy from a heating layer in the one or more strips to an underlying skin area.

[0076] 33) The method according to 32) further includes indicating temperature changes in the one or more strips by means of a thermochromic layer in thermal communication with the heating layer.

[0077] 34) The method according to 32), wherein applying thermal energy from the heating layer comprises increasing the temperature of the one or more strips to a temperature in the range of about 20°C to 55°C.

[0078] 35) The method according to 32), wherein applying thermal energy from the heating layer comprises applying the thermal energy for a period of time ranging from about 5 minutes to 24 hours.

[0079] 36) The method of 29), wherein emitting energy comprises extracting thermal energy from an underlying skin area via a cooling layer in the one or more strips.

[0080] 37) The method according to 36), wherein extracting thermal energy includes cooling the cooling layer to a temperature range of about 0°C to 37°C.

[0081] 38) The method according to 29), wherein the one or more strips each have a length ranging from about 1 mm to 50 mm.

[0082] 39) The method according to 29), wherein the one or more strips each have a width ranging from about 1 mm to 25 mm.

[0083] 40) The method according to 29) further comprising program-controlling the one or more ribbons via a controller attached to the one or more ribbons.

[0084] 41) The method according to 40), wherein program control includes controlling one or more parameters of the one or more strips.

[0085] 42) The method according to 41), wherein controlling comprises controlling the temperature, treatment time, treatment frequency or thermal profile of the one or more strips.

[0086] 43) The method of 29) further comprising attaching one or more additional strips to a second skin area adjacent to the subject's tear gland.

[0087] 44) The method according to 29) further comprising applying pressure or force to the underlying skin area via one or more biasing mechanisms positioned along the one or more strips.

[0088] 45) The method according to 29) further includes imparting mechanical vibration to the underlying skin area.

[0089] 46) The method according to 29) further includes applying electricity or electrical stimulation to the underlying skin area.

[0090] 47) The method according to 29) further includes alerting the subject via an indicator positioned along the one or more strips.

[0091] 48) The method of 29) further comprising applying one or more pharmaceutical, biological or chemical agents to the underlying skin via the one or more strips.

[0092] 49) The method according to 29), wherein the method for treating dry eye syndrome further comprises treating meibomianitis, blepharitis, anterior blepharitis, posterior blepharitis or ocular rosacea.

[0093] 50) The method according to 29) further includes stimulating the subject to assist blinking, trigger blinking, or maintain closure longer during blinking.

[0094] 51) A treatment system for dry eye syndrome, comprising:

[0095] one or more straps configured to be attached to an area of skin beneath one or both eyes of a subject such that the one or more straps allow the subject to blink naturally without being constrained by the one or more straps; and

[0096] a controller in communication with the one or more ribbons, the controller being programmable for therapeutic therapy,

[0097] The one or more strips are configured to transmit energy to an underlying skin region, and wherein the one or more strips are shaped to conform to a location of one or more meibomian glands contained within the underlying skin region.

[0098] 52) The system according to 51), wherein the energy comprises thermal energy.

[0099] 53) The system of 51) wherein the one or more strips comprise a contact surface for placement against the skin area.

[0100] 54) The system of 51) wherein the one or more strips comprise a heating layer in thermal communication with the skin area.

[0101] 55) The system according to 54) also includes a thermochromic layer thermally connected to the heating layer.

[0102] 56) The system of 51), wherein the one or more strips each have a first curved or arcuate periphery shaped to extend and conform to the boundary of one or more meibomian glands and a second curved or arcuate periphery shaped to extend and conform to the free edge of the upper or lower eyelid.

[0103] 57) The system of 51), wherein the controller is coupled to the one or more ribbons via a connecting cable.

[0104] 58) The system of 51) wherein the controller is programmed to control one or more parameters of the one or more strips.

[0105] 59) The system of 51), wherein the one or more parameters include temperature, treatment time, treatment frequency or thermal profile of the one or more strips.

[0106] 60) The system according to 51) also includes a portable electronic device that is detachably coupled to the controller.

[0107] 61) The system of 60), wherein the portable electronic device comprises a smartphone or a tablet computer.

[0108] 62) The system of 61) wherein the smartphone is programmed to provide audible, visual or tactile indicators for communicating with the user.

[0109] 63) A method for treating dry eye syndrome, comprising:

[0110] attaching one or more strips to an area of skin adjacent one or both eyes of a subject such that the one or more strips allow the subject to blink naturally without being constrained by the one or more strips;

[0111] initiating treatment of the skin area using the one or more strips via a controller in communication with the one or more strips,

[0112] Energy is emitted from the one or more strips to the skin area, wherein the one or more strips are shaped to conform to the location of one or more meibomian glands contained within the skin area.

[0113] 64) The method of 63), wherein attaching comprises positioning the one or more strips adjacent to one or both eyes such that a first curved or arcuate periphery of the one or more strips extends and follows a boundary of one or more meibomian glands and a second curved or arcuate periphery of the one or more strips extends and follows a free edge of the upper or lower eyelid.

[0114] 65) The method according to 63), wherein attaching comprises placing the contact surface of the one or more strips against the skin area.

[0115] 66) The method of 63) wherein emitting energy comprises applying heat energy from a heating layer in the one or more strips to an underlying skin area.

[0116] 67) The method of 63) wherein starting comprises program controlling the one or more belts via a controller attached to the one or more belts.

[0117] 68) A method according to 67), wherein program control includes controlling one or more parameters of the one or more strips.

[0118] 69) The method according to 67), wherein controlling comprises controlling the temperature, treatment time, treatment frequency or thermal profile of the one or more strips.

[0119] 70) The method according to 63), wherein starting also includes displaying at least one parameter on a portable electronic device that is removably coupled to the controller.

[0120] 71) The method according to 70) also includes interfacing with a touch screen interface of the electronic device.

[0121] 72) The method according to 70) also includes using the electronic device to wirelessly communicate with a remote server. BRIEF DESCRIPTION OF THE DRAWINGS

[0122] Figure 1A Shown is a cross-sectional side view of the upper eyelid and an example of the location of the meibomian glands.

[0123] Figure 1BShown is a front view illustration of the distribution of the meibomian glands in a human eyelid with the upper and lower eyelids in a closed position, such as when a patient blinks, and the alignment of the meibomian glands on both the upper and lower eyelids.

[0124] Figure 1C A perspective view of a patient's eye in an open position is shown to illustrate how the meibomian glands are typically aligned relative to each other when the patient's eye is opened.

[0125] Figure 2A Shown is a front view of a patient's eye in a closed position, with an embodiment of a therapeutic strip attached to the upper or lower eyelid (or both), and wherein the strip is sized or contoured for placement directly over the meibomian glands located in the underlying eyelid.

[0126] Figure 2B Shown Figure 2A FIG2 shows a therapeutic strip of a patient's eye that illustrates how the strip can remain attached to the patient's skin while allowing the eyelid to retract and allowing the patient to continue blinking while looking out of the eye normally. While the strips can be applied from the eyelid margin to the eyelid crease, they can optionally be flexed or folded and / or compressed during blinking to prevent impairment of normal blinking and maximize comfort.

[0127] Figure 3A An embodiment of a contoured treatment ribbon is shown.

[0128] Figure 3B An embodiment of a cross-sectional side view of a treatment ribbon is shown.

[0129] Figure 3C Another variation of a therapeutic belt that may optionally incorporate a controller is shown.

[0130] Figure 3D Yet another variation is shown in which the treatment strip may be formed into a zigzag or curved configuration to assist the patient in blinking.

[0131] Figure 4 Shown is a front view of another variation of a treatment strip that is relatively thin and positioned on the upper eyelid.

[0132] Figure 5 Shown is a front view of another variation of a relatively thick treatment strip for targeted treatment of the meibomian glands and surrounding tissue.

[0133] Figure 6 A front view of another variation of a treatment strip contoured to more closely conform to the meibomian glands in the upper eyelid is shown.

[0134] Figure 7 Shown is a front view of another variation of a therapeutic strip that may be formed as a shortened strip for selective placement along the eyelid.

[0135] Figure 8 Shown is a front view of another variation of a therapeutic strip that is relatively thin and contoured for placement along the lower eyelid.

[0136] Figure 9 Shown is a front view of another variation of a therapeutic strip that is relatively thick and also contoured for placement along the lower eyelid.

[0137] Figure 10 Shown is a front view of another variation of a treatment strip that is relatively thick for placement along the lower eyelid.

[0138] Figure 11 A front view of another variation of a treatment strip that is contoured for use on the lower eyelid and can be shortened to various lengths is shown.

[0139] Figure 12 A front view of another variation of a relatively straight and selectively shortened treatment ribbon is shown.

[0140] Figure 13 A front view of another variation of a contoured therapy ribbon is shown and further illustrates how ribbons of different sizes may be used in combination with one another.

[0141] Figure 14 Shown is a front view of another variation of a treatment strip sized to conform not only to the meibomian glands along the lower eyelid, but also to the surrounding tissue area.

[0142] Figure 15 A front view of another variation of a treatment strip contoured to conform to the meibomian glands along the lower eyelid in concert with the surrounding tissue area is shown.

[0143] Figure 16 A front view of yet another variation is shown in which the strip is contoured to conform to at least a portion of a meibomian gland and is contoured to cover a selected area of surrounding tissue.

[0144] Figure 17 A front view of yet another variation is shown whose contours are controlled to selectively treat specific areas of underlying tissue.

[0145] Figure 18 A front view of yet another variation is shown in which contoured treatment strips may be used in combination to treat both the upper and lower eyelids.

[0146] Figure 19 A front view of yet another variation is shown in which the treatment strip can change color to more closely match the underlying skin tone.

[0147] Figure 20 A front view of yet another variation is shown in which the treatment strip can be sized to treat specific meibomian glands.

[0148] Figure 21 A front view of yet another variation is shown in which the strips can be changed in size to selectively treat specific meibomian glands.

[0149] Figure 22 A front view of yet another variation is shown in which the treatment strip can be sized to treat the corresponding meibomian glands.

[0150] Figure 23 A front view of yet another variation is shown in which the treatment strip can be sized for placement along the lower eyelid.

[0151] Figure 24 Shown is a front view illustrating the relative positioning of the lacrimal glands.

[0152] Figures 25 to 27 Variations of treatment strips that can be contoured and positioned for treating the underlying tear gland are shown.

[0153] Figures 28 to 30 Variations of treatment strips are shown that can be contoured and sized to treat the meibomian glands in combination with optionally also treating the lacrimal glands.

[0154] Figure 31 and Figure 32 Variations of treatment strips are shown that can be sized to selectively treat specific meibomian glands in combination with the lacrimal glands.

[0155] Figure 33 Another variation of a therapeutic strip is shown that may have mechanical biasing features incorporated along the strip for applying force to the underlying tissue and meibomian glands.

[0156] Figure 34 Shown Figure 33 Detail perspective view of a treatment ribbon illustrating an embodiment of a biasing mechanism incorporated along the ribbon.

[0157] Figure 35 Another variation of a treatment strip incorporating one or more transducers for imparting vibratory forces to the underlying tissue and meibomian glands is shown.

[0158] Figure 36 Yet another variation of a therapy ribbon is shown incorporating electrodes throughout the length of the ribbon.

[0159] Figure 37 Yet another variation of a therapy belt incorporating microwave antennas along the belt is shown.

[0160] Figure 38 Yet another variation of a therapy ribbon is shown that incorporates a timer and indicates when therapy has been completed to alert the user.

[0161] Figure 39 Yet another variation of an eyelid treatment system is shown that can be coupled to a portable remote control, such as a smartphone or tablet. DETAILED DESCRIPTION

[0162] In treating conditions such as meibomian gland dysfunction (MGD), which is commonly associated with the evaporative form of dry eye syndrome (DES), a patch, strip, or thin adhesive device can be affixed to the skin of the upper and / or lower eyelid to deliver heat or other forms of energy, pressure, medication, moisture, etc., alone or in combination, to one or more meibomian glands contained within the underlying skin. In particular, one or more treatment strips can be specifically configured and sized for placement on one or more target meibomian glands contained within the skin of the upper and / or lower eyelid. Applying thermal therapy, such as heating or cooling, can be very easy across the eyelid because the eyelid is substantially the thinnest skin found on the human body and the tissue is highly vascularized. Because the root of the eyelid is located proximally and the eyelid margin is located distally, the reticuloarterial flow of blood flows from proximal to distal. So no matter where these treatment strips are placed, heating or cooling therapy can be easily implemented throughout the eyelids and any structures contained therein, such as the meibomian glands MG, lacrimal glands LG, palpebral glands GZ, Melech glands GM, Wolfflin glands GW, Kraus glands GK, etc.

[0163] In addition, because the eyelid is so thin, heating or cooling therapy can be transmitted to the surface of the eye and the eye itself (described in more detail below). Thus, therapy can impart energy to the conjunctiva, goblet cells, scleral vasculature, cornea, aqueous humor, iris, ciliary body, and possibly the anterior vitreous and lens. Therefore, any thermal therapy through the treatment ribbon can also affect and be used to treat ocular surface disorders and anterior segment diseases, such as conjunctivitis, keratitis, corneal disease, iritis, cyclitis, glaucoma, cataracts, etc. In addition, there can be use in the post-operative state, such as after LASIK, PRK or cataract or corneal surgery or other ocular, periocular, intraocular or eyelid surgery, as described in more detail below.

[0164] As in Figure 2A , one variation of such a treatment strip can be viewed as being temporarily attached to the upper eyelid UL and lower eyelid LL (when closed for illustrative purposes) on the eye of a patient P. The contoured upper strip 10 can be sized for direct attachment to the skin of the upper eyelid UL such that the strip 10 has a configuration and shape that conforms to the location of one or more meibomian glands contained within the underlying skin of the upper eyelid UL. Similarly, the contoured lower strip 12 can also have a configuration and shape that conforms to the location of one or more meibomian glands contained within the underlying skin of the lower eyelid LL. In other variations, the contoured strip can stop at or pass over the eyelid crease, as described below in other variations.

[0165] The upper strip 10 can thus have an upper curved or arcuate periphery 14 shaped to extend and conform to the upper (or superior) border of the meibomian glands (e.g., along or up to the upper eyelid crease), and a lower straight periphery 16 can be shaped to extend and conform to the lower (or inferior) border of the meibomian glands, e.g., along the free edge of the upper eyelid UL. The lower strip 12 can similarly have an upper straight periphery 20 to extend and conform to the upper (or superior) border of the meibomian glands along the free edge of the lower eyelid LL, and a lower curved or arcuate periphery 18 to extend and conform to the lower (or inferior) border of the meibomian glands along the lower eyelid LL (e.g., along or up to the lower eyelid crease). The terms lower and upper are used herein to refer to the periphery of the treatment strip when placed on a patient P (human or animal) and are used herein for descriptive purposes.

[0166] Although both treatment strips 10, 12 are shown attached to the respective upper and lower eyelids UL and LL, the strips 10, 12 can be used for placement only on the upper eyelid UL or only on the lower eyelid LL, respectively, depending on the desired treatment. Furthermore, the lengths of the treatment strips 10, 12 can also be varied to target the respective meibomian glands to provide targeted treatment, if desired, as described in greater detail herein.

[0167] While the treatment strips 10, 12 are shown as being placed on the closed eyelids of patient P, the strips 10, 12 are curved or flexible enough to follow the curvature of the patient's eyelid margin and can be long enough to cover some or all of the underlying meibomian glands in the tarsal plate. While the treatment strips 10, 12 can be generally sized, they can also be custom-made or sized or shaped to optimize adhesion and / or comfort and / or stability for a specific individual's eyelid dimensions. Generally, the treatment strips 10, 12 can have a length ranging from approximately 1 mm to 50 mm, depending on the desired treatment length and the patient's anatomy, as the typical palpebral fissure length in adults is approximately 27 mm to 30 mm. Thus, to cover up to all of the meibomian glands, the treatment strips 10, 12 can be sized to have a length of, for example, 25 mm to 30 mm, or, if sized to cover slightly more than all of the meibomian glands, a length of, for example, 30 mm to 50 mm (or more, if desired to optimize adhesion / comfort / stability). Furthermore, one or both of the treatment strips 10, 12 can have a width ranging anywhere from about 1 mm to 25 mm, since the typical eyelid crease in Caucasian males is about 8 mm to 9 mm above the eyelid margin, and in Caucasian females it is about 9 mm to 11 mm above the eyelid margin (or more, if desired for fit / comfort and potentially increased efficacy from heating or cooling inflow blood flow). Customization enables it to fit any specific anatomy, race, ethnicity, etc. Furthermore, the treatment strips can be manufactured with varying levels of flexibility to accommodate eyelid ergonomics and eyelid blinking for optimal comfort and minimal intrusiveness or movement.

[0168] Because of the specifically controlled contoured size and flexibility of the treatment strips 10, 12, the treatment strips can be placed on the patient P by the patient himself / herself for consumer use or by a care provider to apply therapy to the underlying meibomian glands, allowing the patient's eyes to be opened and closed normally, as in Figure 2B While the strips can be applied from the eyelid margin to the eyelid crease, they can optionally be flexed or folded and / or compressed during blinking to prevent impairment of normal blinking and maximize comfort.

[0169] Typical treatment patches, such as those used for application of warm compresses, are typically sized for placement across one or more eyes, such that the patient cannot open their eyes or blink during the treatment period. However, because of the strong association between DES and MGD (e.g., MGD includes the spectrum of MGD, meibomitis, blepharitis, and ocular rosacea), an individual's natural blinking is the mechanism by which meibomian gland secretions are normally released onto the eyelid margins and through tears. In the absence of blinking, the oil contained within the meibomian glands remains unexpressed within the gland's terminal ducts and cannot contribute to the distribution of the oily layer on the tears.

[0170] Accordingly, the contoured size, shape, and flexibility of the treatment strips 10, 12 allow treatment to occur while also allowing the patient to keep one or both eyes open so that normal, physiological blinking can occur during the treatment process. Instead of relying on the application of any type of external force to express oil or obstructions from the glands, the treatment strips 10, 12 utilize the eye's natural mechanism to clear oil from the meibomian glands through blinking. Thus, the treatment strips 10, 12 can be attached in position for treatment without any further intervention from the patient or caregiver, allowing the treatment strips 10, 12 to apply, for example, thermal energy to melt or liquefy any waxy or solid meibomian gland obstructions while the eyes remain unobstructed and allowed to blink naturally. The treatment strips 10, 12 thus allow natural blinking to clear the heat-treated, softened obstructions from the glands until they have resolidified, unlike other treatments that require the patient to keep their eyes closed or obstructed during the treatment process and prevent or inhibit the patient from blinking. The delivery of heat may also increase blood flow by promoting vascularization, as the increased delivery of blood may affect metabolism, the temperature of other tissues, may have an effect on inflammation, and may thereby improve tissue function.

[0171] Because some patients have obstructions or occlusions in their meibomian glands that may not sufficiently melt, loosen, or soften without achieving elevated temperatures at the meibomian glands, the treatment strips 10, 12 can apply heat or other treatments to the surface of the eyelids for extended periods of time, for relatively long treatment times and at higher treatment temperatures, due to the ability of the treatment strips 10, 12 to remain attached to the patient at any given time during the day. Patients can carry out their daily activities while their eyes are open and blinking, enjoying the comfort of the strip-based treatment. Furthermore, patients can attach the treatment strips as many times as needed throughout the day, week, month, etc., until dry eye symptoms subside. This increases treatment frequency, convenience, and, therefore, effectiveness.

[0172] Because of the extended treatment time, application of separate force beyond the application of the strip may not be required, as long as the patient is able to continue blinking during the course of treatment. Furthermore, the frequency of treatment can be varied, depending on the severity of the condition being treated. One example of a potential treatment frequency could include application of one or two strips, for example, up to six times daily for ten minutes or up to an hour or more per treatment. Furthermore, because the treatment strip is positioned over the meibomian glands covering the ocular surface, application of heat therapy can also indirectly heat the ocular surface and further reduce any chronic ocular surface inflammation, chronic conjunctival inflammation, or corneal neovascularization.

[0173] In addition to heating of the ocular surface, thermal therapy can also optionally be used to potentially provide indirect heating through the ocular surface and provide heating of the retina to provide thermal therapy to limit inflammation and neovascularization, which are underlying conditions for diseases such as wet age-related macular degeneration (AMD) and diabetic retinopathy.

[0174] While the therapeutic strips 10, 12 may be used throughout the day to take advantage of the patient's physiological blinking, the therapeutic strips 10, 12 may also be used while the patient is resting or sleeping, or while the patient is simply keeping their eyes closed.

[0175] The treatment strips 10, 12 are desirably flexible enough to accommodate movement of the upper eyelid UL and / or lower eyelid LL, which may move up to about 15 mm or more. Accordingly, the treatment strips 10, 12 may be manufactured from a variety of materials. Figure 3A and Figure 3B Various front and cross-sectional side views of one embodiment of a therapeutic ribbon are shown that is configured to have an adhesive 32 positioned around the periphery of the ribbon to leave a contact area 30 for direct placement against the skin surface. The contact area 30 may also include a humidifying layer to interface between the ribbon and the skin to assist in heat transfer from the ribbon and to provide humidification therapy to the skin. Optionally, the therapeutic ribbon may be used in conjunction with any number of humidifiers that can be applied to the underlying skin separately from the therapeutic ribbon by the patient P or by a practitioner. In addition, the contact area 30 may be formed to have a surface that is smooth, porous, irregular, corrugated, etc. to assist in contact and transfer of heat from the therapeutic ribbon to the skin surface. Optionally, the entire contact area 30, including its periphery, may be adhesive to maintain good contact. It may be hinged or curved to allow flexing or folding, for example for comfortable dynamic movement and, preferably, physiologically sound ergonomics. In use, the ribbon may be applied under tension, such as Figure 3DThe strap 10' is shown tensioned in order to further reduce any impairment to blinking, and once attached to the skin, the strap can be released to allow flexion thereof, as also shown in FIG. Figure 3D The released ribbon 10" is shown to assist patient P in blinking.

[0176] In this variation, the therapeutic ribbon 10 can be configured with a contact layer 34 (e.g., made of a conductive material such as metal, alloy, porous ceramic, engineered ceramic, wood, polymer, composite, foam, polymer foam, elastomer, etc.) that protects the skin from burns or any other adverse effects. A second heating layer 36 can be positioned above (or in direct contact with) the contact layer 34 to generate heat energy, and an insulating layer 38 can be positioned on top of the heating layer 36 to concentrate, direct, or reflect heat toward the underlying skin surface and to protect the patient from contact with the heating layer 36 from other parts of the body. The insulating layer 38 can be made of a variety of insulating materials, such as foam, foam tape, gauze, silicone, microporous polyethylene film, metal, alloy, reflective material, mirror, etc. Furthermore, the thickness of the therapeutic ribbon 10 can vary, for example, from approximately 1 / 64" to 1 / 8" or more, depending on the mechanism of the heating layer 36, as well as the desired thermal profile and target transmission temperature. Additionally and / or alternatively, the insulating layer 38 may contain a thermochromic material that may change its color when the target temperature has been reached by the therapy ribbon 10 to indicate to the patient that the target temperature has been achieved or when therapy has been completed.

[0177] The heating layer 36 can be configured to generate its thermal energy through any number of various mechanisms, such as mechanical, electrical, or chemical mechanisms, for example, up to a temperature range of approximately 20°C to 55°C (or more) or between 40°C and 50°C. In one variation, the heating layer 36 can include an air-activated warmer that can increase to an elevated therapeutic temperature for a period of, for example, 5 minutes up to 24 hours or even longer. One embodiment can include an air-activated layer incorporating, for example, iron. Other embodiments can incorporate a heating layer 36 containing, 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 iron when exposed to air. Other variations can include heating layers 36 incorporating light-based activation (powered by visible or ultraviolet light) or the use of supersaturated solutions (crystalline forms) to initiate and / or maintain the exothermic reaction.

[0178] Alternatively, in addition to the use of the thermochromic material to determine when the treatment ribbon has reached a specified temperature, a separate temperature sensor 39 (e.g., a thermocouple or thermistor device) may be incorporated into the treatment ribbon 10, as in Figure 3B The therapy belt 10 may also incorporate an optional controller and / or display 37 having a processor that may be programmable and may incorporate a separate on / off feature, as shown in FIG. Figure 3C . The temperature sensor 39 can be in communication with a controller 37 that can be programmed to adjust the temperature of the heating layer 36 and / or the length of time for a particular treatment. The controller 37 can accordingly be programmable by a physician or caregiver or by the patient directly. Alternatively, the controller 37 can be configured to be inaccessible to the patient, but can only provide a temperature and / or time indication for display to the patient. Where the controller 37 is programmable, the controller 37 can be programmed, for example, to set the length of the heating period, set the treatment time, set a predetermined temperature range, control a heating temperature profile (e.g., gradually increase the heating temperature or decrease the temperature over a predetermined time period), etc.

[0179] In another variation, the heating layer 36 can generate heat through the exothermic crystallization of a typically reusable supersaturated solution (typically sodium acetate). The therapeutic strips can be recharged by heating them, for example by boiling, and then allowing them to cool. The heating of these therapeutic strips can be triggered by snapping on small metal devices embedded in the therapeutic strips that create nucleation centers that initiate crystallization. Heat is required to dissolve the salt in its own water of crystallization, and this heat is released when crystallization begins.

[0180] In yet another variation, the heating layer 36 can include a battery-operated warmer utilizing a resistive heating element that converts electrical energy from the battery into thermal energy. The power source can be internal or external to the therapy ribbon and the therapy ribbon can be charged, for example, by direct electrical contact, induction, etc.

[0181] Other mechanisms that can be incorporated into the heating layer 36 can include chemically actuated reactions, such as those used by sodium acetate heating pads. For example, single-use chemical reactions that utilize the catalyzed rusting of iron or the dissolution of calcium chloride can be used, wherein the reagents are held in separate compartments within the treatment strip. When the patient squeezes the treatment strip, the compartments can break and the reagents are mixed to generate heat. An embodiment can include the use of a supersaturated solution of sodium acetate (NaCH3COO) in water, wherein crystallization can be triggered by flexing a small, flat disk of notched ferrous metal embedded in the liquid, which serves as a nucleation site for the crystallization of sodium acetate into a hydrated salt (sodium acetate trihydrate). Because the liquid is supersaturated, this causes the solution to crystallize suddenly, which releases lattice energy.

[0182] Another example of use in the heating layer 36 may include the use of a thermal gel containing a supersaturated solution of a salt. Heat may be generated when the crystallization of a given salt occurs exothermically. Such a heating layer 36 may be reused by forcing the salt back into solution within the heating layer 36.

[0183] Still other embodiments for incorporating the heating layer 36 may also include the use of high specific heat capacity materials that can be heated, such as by being placed in a microwave prior to use, and then allowed to release heat over a specified period of time.

[0184] While the application of thermal energy from the treatment strip is described, other variations may alternatively include the use of the treatment strip for cooling the underlying skin. Instead of using an exothermic reaction to heat layer 36, the layer may be configured to instead utilize an endothermic reaction to provide cooling of the skin within a temperature range, for example, from approximately 0°C to 37°C, or more specifically, from approximately 25°C to 35°C. One example may include incorporating water and ammonium nitrate or ammonium chloride into layer 36. The water and ammonium mixture may lower the temperature of layer 36. Another variation may include the use of a cooling gel manufactured by incorporating hydroxyethylcellulose or vinyl-coated silicone that can be cooled or frozen prior to use. Alternatively, cooling may be achieved through the use of a cooling element, such as a Peltier connector. Cooling, rather than heating, may be applied for conditions such as reducing inflammation, allergies, or eye strain, particularly while the patient is resting or sleeping. One example includes the treatment of allergic conjunctivitis, where the application of cooling therapy can provide relief from any burning or itching sensation by acting as a vasoconstrictor to restrict blood flow, reduce vascular leakage and permeability, thereby reducing acute swelling and inflammation. Yet another example includes reducing inflammation and fibrosis of conjunctival blebs resulting from trabeculectomy or relieving inflammation typically following any ophthalmic surgical procedure.

[0185] Given the variety of mechanisms for incorporating the heating layer 36, the therapeutic ribbon can be configured as a single-use disposable ribbon, a multiple-use disposable ribbon, a reusable ribbon, selectively actuatable, or the like.

[0186] In addition to the application of thermal energy from the treatment ribbon, the ribbon may also include a layer for the diffusion or release of one or more pharmaceutical, biological, or chemical agents, either alone or in combination with thermal treatment. For example, a pharmaceutical, biological, or chemical agent may be incorporated into the contact layer 34, the thermally insulating layer 38, or entirely in a separate layer for transdermal delivery to the meibomian glands or the area surrounding the meibomian glands for additional and / or alternative treatment. For example, examples of some of the various pharmacological agents that may be incorporated into the treatment strip (for use with or without heat treatment) may include, but are not limited to, anti-inflammatory compounds, antibiotics, topical tetracyclines, oral tetracyclines, topical corticosteroids, oral corticosteroids, topical androgens, metronidazole, steroid antagonists, topical androgen analogs, TGF-β, ω3 or ω6 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 secretion, agents that replace or promote the production of any tear component that may be used, cholinergic agonists, muscarinic agonists or nicotinic agonists, cosmeceuticals such as retinol or hyaluronic acid (HA) for wrinkled, swollen or sagging skin in the cosmetic space, retinoic acid for acne, or agents that degrade or break down lipids such as lipase, etc.

[0187] Other agents may include, for example, alpha melanocyte stimulating hormone or adrenocorticotropic hormone or androgens such as testosterone to increase tear production, agents that stimulate underlying muscles such as the orbicularis oculi or Riolan muscles to stimulate blinking, increase the frequency of blinking, or maintain closure longer after blinking, by inhibiting the levator palpebrae superioris muscle to promote blinking or eyelid closure or otherwise mechanically compressing the meibomian glands or Zeiss glands or other goblet cells or accessory lacrimal glands.

[0188] Additionally and / or alternatively, other agents for incorporation into the therapeutic ribbon may also 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 secondary signaling pathways, such as activation of the calcium / protein kinase C pathway, activation of G proteins, other calcium-dependent pathways, calcium-calmodulin-dependent protein kinases, cyclic AMP-dependent pathways, adenylate cyclase pathways, and inhibition of cAMP-dependent phosphodiesterases.

[0189] In cases where a pharmacological or chemical agent is released during heat treatment, the heat can help improve any penetration of the drug into the underlying skin.

[0190] Yet another variation may incorporate a treatment strip that applies heat friction, which can be applied to the upper eyelid UL and / or lower eyelid LL for treatment of the meibomian glands or a compound that attracts light and heat. Each of these variations may allow the treatment strips 10, 12 to be applied and used while allowing natural blinking to occur, thereby helping to clear the ducts of the meibomian glands from molten oil and aiding in the distribution of the oil into the tears.

[0191] While the treatment strip can incorporate various layers into the strip to result in a variety of different treatments, the strip can also be varied in size, shape, contour, etc., depending on the desired treatment area, so long as the treatment strip is contoured or shaped to conform to the location of at least one meibomian gland. An example of another configuration of the treatment strip is Figure 4 , which illustrates a contoured, thinned strip 40 that is sized and shaped for placement along the upper eyelid UL. The treatment strip can have a contoured lower edge 42 and a contoured upper edge 44 that conform to the positioning of the underlying meibomian glands. Furthermore, while the strip 40 is shown as being placed on the upper eyelids UL of both eyes of a patient P, a single strip 40 can be used on a single eyelid to selectively treat specific meibomian glands, in this embodiment as well as in other embodiments shown herein. Furthermore, one or both upper eyelids UL can be treated alone or in combination with one or both lower eyelids LL, depending on the desired treatment, in this embodiment as well as in other embodiments shown herein.

[0192] Another variation is Figure 5 , which shows a contoured, thickened 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 other variations, instead of utilizing two separate treatment strips, a single strip extending across the bridge of the patient's nose may also be used. In addition, the thickened strip 50 may cover a portion of the skin further proximally away from the eyelid margin to aid in treatment. Because the arterial blood supply to the eyelid travels from proximal to distal to the eyelid margin, the treatment strip may heat (or cool) the blood supply as it continues to flow toward the eyelid margin. This early heating (or cooling) may provide the patient with a therapeutic effect with enhanced comfort, less impact on eyelid function (e.g., blinking), and increased safety of application and distance from the ocular surface, as well as potentially increased efficacy allowing for more complete heating or cooling therapy.

[0193] Figure 6Yet another variation of a thinned strip 60 having a controlled profile is shown in which a lower edge 62 and an upper edge 64 converge into a tapered end 66 for placement over the meibomian glands. Figure 7 Yet another variation is shown in which the treatment strip may include a straight strip 70 having a first width that is also used in combination with a thinned straight strip 72. The straight strip 70 may include a straight strip (with optionally rounded corners) that can be selectively placed over the meibomian glands. In this embodiment, a single straight strip 70 can be applied to the upper eyelid UL of a single eye, and the remaining eyes can utilize a single straight strip 70 applied along a first portion of the upper eyelid UL and a second straight strip 72 having a relatively thinner width for placement on a second portion of the upper eyelid UL. Each of the strips can be applied alone or in various combinations, depending on the desired treatment area, and are shown as exemplary combinations in this variation.

[0194] exist Figure 8 In a variation of this embodiment, one embodiment of a contoured, thinned strip 80 is shown applied along the lower eyelid LL. As shown, the contoured upper edge 82 and the contoured lower edge 84 can be contoured to conform to the underlying meibomian glands. As described above, the treatment strips can be applied alone to one or both eyes or in combination with a treatment strip applied to one or both upper eyelids. Furthermore, any of the treatment strips shown herein can be used in any number of combinations with one another.

[0195] Figure 9 Another variation is shown in which a contoured thickened strip 90 may be applied to the lower eyelid LL and may also have a greater thickness than that shown above. Figure 8 The treatment strips shown in FIG are relatively wider in width. Similarly, Figure 10 Yet another variation is shown in which the contoured thickened strip 92 can have a relatively wider width that still treats not only the underlying meibomian glands but also any glands and tissues surrounding the periorbital area. Figure 5 As described in the variations of FIG, the widened treatment strip can heat (or cool) the blood supply as it continues to flow toward the eyelid margin. Early heating (or cooling) can provide a therapeutic effect for increased comfort to the patient, less impact on eyelid function (e.g., blinking), and increased safety of application and distance from the ocular surface.

[0196] In addition to variations in the width of the treatment strips, the length of any treatment strip may also be varied to selectively target portions of the meibomian glands or specifically selected meibomian glands. For example, Figure 11 A variation is shown in which a shortened contoured strip 100 having a first shortened length can be applied to the lower eyelid LL (and / or to the upper eyelid UL). A second contoured strip 102 having a second length longer than the shortened contoured strip 100 can also be seen for comparison. Figure 12 Similarly, a shortened, straight strip 110 is shown applied to the lower eyelid LL, and a second, straight strip 112 of relatively longer length is shown applied to the second lower eyelid LL. The straight strips 110, 112 may incorporate rounded ends and may vary in length, depending on the desired treatment area. They may also be rounded or rounded to cover one or more styes.

[0197] Figure 13 Yet another variation is shown in which the contoured strip 120 can be configured with tapered ends for covering the meibomian glands. In comparison, a thickened contoured strip 122 is also shown with tapered ends, still relatively wide, to vary the treatment area.

[0198] Figure 14 Another variation is shown in which a contoured strip 130 may have a first portion 132 that is relatively wider than a second portion 134 for placement over the meibomian glands of the lower eyelid LL. The width of each of the first portion 132 and the second portion 134 may vary, again depending on the desired treatment area. Another embodiment is shown in FIG. Figure 15 , which shows a contoured strip 140 having a first portion 142 and a second portion 144 that are significantly wider to treat not only the meibomian glands along the lower eyelid LL but also surrounding periorbital tissue areas such as the underlying maxillary sinus. Figure 16 Yet another embodiment of a contoured strip 150 is shown having a first portion 152 and a second portion 154 that is wider than the first portion 152, and wherein the strip 150 is positioned to cover only a portion of the meibomian glands along the lower eyelid LL and also to cover various other glands around the periorbital area, such as the lacrimal glands.

[0199] Figure 17Yet another variation of a treatment strip is shown, including a contoured strip 160 having a secondary, enlarged portion 162 attached via a connecting strip 164. While the contoured strip 160 can treat the meibomian glands along the lower eyelid LL, the secondary, enlarged portion 162 can treat an area of tissue along the patient's cheek.

[0200] In yet another variation, Figure 18 An example is shown in which both an upper contoured strip 170 and a lower contoured strip 172 can be applied along the upper eyelid UL and the lower eyelid LL, respectively. As discussed above, the contoured strips 170, 172 are shaped and applied to conform to the underlying meibomian glands while enabling the patient P to blink normally. Figure 19 An upper contoured ribbon 180 and a lower contoured ribbon 182 are shown similarly applied, wherein the color of the ribbons may be varied to more closely match the skin tone or shade of the patient P. Because the therapy ribbons may be used throughout the day for any given period of time, the ribbons 180, 182 may be manufactured in a variety of colors or shades to more closely match the skin tone or shade of the patient P.

[0201] In yet another variation, Figure 20 Another embodiment is shown in which the length of the treatment strip can be varied to treat specific areas along the upper eyelid UL or lower eyelid LL. In this embodiment, a first upper strip 190 having a first length can 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 a relatively shorter length can also be applied to selected meibomian glands. A lower strip 198 having an enlarged distal end 200, 202 is also shown for placement along the lower eyelid LL. The distal end 200 can be shaped to assist in 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, such as a first upper strip 210 and a second upper strip 212 selectively placed along the upper eyelid UL, and a first lower strip 214 and a second lower strip 216 selectively placed along the lower eyelid LL. The length and size of each strip can vary depending on the treatment area.

[0202] Because the length of the treatment strips is variable, multiple strips can be applied adjacent to each other or overlapped horizontally and / or vertically along the eyelid. In addition, one or more of the treatment strips can be manufactured as a single unit or as a series of panels in horizontal or vertical directions that can be optionally connected by a flexible backing. Figure 22 As shown in the variation of , each of the targeting strips 220 can have a length of, for example, about 1 mm to cover as few individual meibomian glands as possible. One or more of the targeting strips 220 can be applied along the upper eyelid UL and / or the lower eyelid LL. In addition, one or more of the targeting strips 222 can also include a connecting member 224 that acts as a backing to couple each of the individual targeting strips 222 to each other. The individual strips can be selectively applied at particularly problematic meibomian glands, along the upper eyelid UL and / or the lower eyelid LL. For example, Figure 23 A separate targeting strip 222 is shown positioned only along the lower eyelid LL.

[0203] While the treatment strips can be applied to one or more of the meibomian glands, variations of the strips can also be used to treat other glands, such as the sebaceous glands, for example, for acne treatment. Treatment strips for acne treatment can utilize different pharmacological therapies. Other glands in the underlying eyelid and conjunctiva CN for treatment can also include, for example, treatment of the Zeiss glands GZ, goblet cells, accessory sebaceous glands, accessory goblet cells such as the glands of Henle and Manz, accessory lacrimal glands of Wolfring GW or Krause GK, or one or both lobes of the main lacrimal gland, such as portions of the eyelid or the orbit.

[0204] In addition, the therapeutic strips can be used to potentially treat eye conditions other than meibomian gland dysfunction, including, for example, blepharitis, Sjögren's syndrome, dacryoadenitis, conjunctivitis, allergic conjunctivitis, keratoconjunctivitis sicca, keratitis, dacryocystitis, iritis, keratitis, retinitis, sclerokeratitis, uveitis, eye problems related to contact lenses, post-blepharoplasty or eyelid or eye surgical procedures (e.g., cataract surgery, LASIK, PRK, etc.), absent or dysfunctional blink disorders, conjunctivitis, blepharospasm, exposure keratopathy, lagophthalmos, eyelid myotonia, infection, styes, chalazion, hordeolum, glaucoma, herpes, trauma, and the like.

[0205] Yet another embodiment, as mentioned above, may include the use of a treatment strip positioned over the eye for treating disorders of the lacrimal gland LG and / or the lacrimal gland PL, such as in Figure 24 Various sizes of therapeutic belts, such as those sized to have a curved upper periphery, are shown in FIG. Figure 25 The lacrimal ribbon 230 shown in FIG. 2 can be sized for placement directly on the skin surface overlying the lacrimal gland LG. Other variations are described in Figure 26 , which illustrates a lacrimal ribbon 232 that is relatively thin in width, and Figure 27 , which illustrates a lacrimal ribbon 234 having a curved periphery terminating in a tapered end. The therapy ribbon can deliver heat, for example, to stimulate the lacrimal gland LG, increase glandular metabolism, activity, tearing, etc. Alternatively, the therapy ribbon can deliver cooling therapy to reduce inflammation that impairs glandular function.

[0206] The lacrimal glands LG and / or the eyelid lacrimal glands PL can be treated alone or in combination with a treatment strip of controlled contour for treating the meibomian glands. Figure 28 , which illustrates a contoured strip 240 whose width is enlarged to cover both the lacrimal gland LG and the meibomian glands along the upper eyelid UL. A contoured treatment strip 242 is also shown placed along the lower eyelid LL for treatment of the meibomian glands as well.

[0207] Figure 29 Another variation is shown in which a tear gland ribbon 250 can be placed over the tear gland LG in combination with an integral, contoured ribbon 252 that is sized to completely encircle the eye while conforming to the location of the meibomian glands along both the upper and lower eyelids UL and LL. This fully encircling design can also be held in place more tightly against the skin by a strip that can be wrapped around the patient's head, if desired. Another variation is shown in FIG. Figure 30 , which illustrates a unitary, contoured ribbon 260 that is also sized to entirely surround the eye and also has a width suitable for placement over the lacrimal gland LG.

[0208] The lacrimal ribbon 270 may be used in combination with any of the therapeutic ribbons shown herein. Figure 31 FIG, which shows the lacrimal ribbon 270 used in combination with a separate ribbon 222, and Figure 32 Yet another embodiment is shown in which a lacrimal ribbon 270 may be used in combination with not only a separate ribbon 222 but also a ribbon 220 positioned along the respective lower and upper eyelids LL and UL.

[0209] While the treatment strip can be applied to the meibomian glands to apply thermal energy, the treatment does not require the application of any external force applied by the strip or any other external device, but rather the patient's natural blinking can be utilized to assist in the treatment, as described above. However, in further variations, the treatment strip can be configured to apply both thermal treatment and external force. Any number of mechanisms can be used to apply a pinching or biasing force to provide compression of the underlying skin and meibomian glands during the application of thermal therapy. One embodiment is described in Figure 33 , which illustrates a biased treatment ribbon 280 that may include a ribbon 282 having one or more biasing mechanisms 284 positioned along the ribbon 282, as described above. The one or more biasing mechanisms 284 may be positioned along the upper ribbon or the lower ribbon, or both, as shown.

[0210] In this embodiment, the biasing mechanism 284 can locally squeeze or compress the underlying skin to apply pressure to the meibomian glands MG to assist in the removal of any obstruction, particularly if applied simultaneously with heat treatment. Figure 34 , which is shown in perspective view, illustrates how biasing mechanism 284 can generally include a portion of ribbon 282 or a separate member that is biased to form a corresponding channel 286 configured to flex in an open or closed configuration. When the ribbon is initially placed on the skin, the ends of the ribbon can be withdrawn to open channel 286, which can then be placed on the skin surface. When the ribbon and biasing mechanism 284 are relaxed, the underlying skin and meibomian glands MG can be compressed or pinched by the compressive force 288 introduced into the biasing mechanism 284.

[0211] In addition to compression, the ribbon may be formed using alternative components such as mechanical components to impart vibrational energy to aid expression of the meibomian glands and promote oil secretion. Figure 35 , which shows another variation of a profiled ribbon 290A, 290B having one or more vibrating elements 292 (e.g., piezoelectric transducers, electromagnetic actuators, eccentrically coupled rotating elements, etc.) incorporated along the ribbon 290A, 290B. The one or more vibrating elements 292 can be electrically coupled to a power source and / or processor 294 also housed along the ribbon 290A, 290B. Furthermore, vibration energy can be imparted separately from or in combination with thermal therapy. The power source can include a micro-battery that can be rechargeable to deliver the microcurrent.

[0212] In addition to the application of mechanical pressure or vibrational energy, other forms of energy may be delivered by one or more of the treatment ribbons. Figure 36, which shows an upper contoured ribbon 300A having conductive elements 302, such as wires integrated along the entire length (or a portion of the length) of the contoured ribbon 300A. The conductive elements 302 can be arranged in an alternating pattern or simply aligned along the length of the ribbon, as shown by the conductive elements 306 (or resistive) along the lower contoured ribbon 300B. Each of the conductive elements 302, 306 can be in electrical communication with a respective power source and / or processor 304, 308. The conductive elements 302, 306 can be selectively actuated to apply thermal energy or they can be configured to apply radiofrequency (RF) energy to the underlying skin and meibomian glands. Regarding the application of electrical energy, one form of electrical energy that the therapeutic ribbon can apply can include the use of a transcutaneous electrical nerve stimulation feature, for example, to deliver neural stimulation to increase tear production. Conductive elements can generate heat energy through various power sources such as batteries, solar cells, kinetic motion, RF, etc.

[0213] Figure 37 Yet another variation is shown in which the contoured strips 310A, 310B can be configured to incorporate electrodes or antennas 312 coupled to a power source and / or processor 314 for applying, for example, microwave energy to the underlying meibomian glands. In addition to electrical or microwave energy, the treatment strips can be configured to apply still other forms of energy to treat the meibomian glands. For example, other variations can incorporate actuators or transmitters to apply ultrasound, RF, microwaves, magnetism, photons (light energy in the infrared or visible spectrum), and the like. In still other variations, the conductive elements can be configured to act as electromagnetic elements once actuated or the strips can incorporate ferromagnetic elements to promote closure of the eyelids. The magnetic force can act to compress the meibomian glands and express the oily obstruction when the eye is opened and reopened in overcoming the magnetic force.

[0214] In yet another variation, one or both of the therapy ribbons 320A, 320B can be configured to incorporate an indicator 324, such as an LED light, an alarm, a vibrating element, etc., electrically coupled to a power source and / or processor 322, to alert the patient when the prescribed treatment is complete. This feature (and any of the other features) can be combined with any of the features of the other variations of therapy ribbons described herein, as practicable.

[0215] Figure 39Yet another variation is shown, in which an eyelid treatment system 330 can be formed as a connected dual-ribbon design, such as a "forked bar" design, wherein the dual-ribbon heating ribbon can have two heating elements that conform to the location of the upper UL and lower LL eyelids of the meibomian glands of a single eye. Depending on whether two eyes or a single eye and / or both the upper and lower eyelids are being treated, the system 330 can include a first heating ribbon assembly 332 and a second heating ribbon assembly 334 for each respective eye. Each of the assemblies 332, 334 can accordingly utilize an upper eyelid treatment heater and a lower eyelid treatment heater, such as an upper eyelid treatment ribbon 332A and a lower eyelid treatment ribbon 332B, wherein each of the upper and lower elements can be coupled to each other via a wire 336. In addition, each of the components 332, 334 can be coupled to a controller 340 via a connection cable 338, and the controller 340 can be coupled (e.g., via an input / output port, such as a headphone jack, a USB port, or other connection port) to a portable electronic device 342 (e.g., a smartphone with a touch screen interface, a tablet computer, a PDA, a laptop, etc.), as shown.

[0216] In other variations, the number of connecting cables can range from approximately 1-4 connector cables, rather than utilizing a single cable 338. For example, one cable can be used to provide power and connectivity to several or all four heating elements in each of assemblies 332, 334. Alternatively, four connecting cables can provide power and connectivity to each heating element in assemblies 332, 334. In still other alternatives, two connecting cables can provide power and connectivity to each of assemblies 332, 334.

[0217] In other additional variations, any of the described treatment strips can be used in combination with the controller 342 described herein, as practicable. In yet another variation, an oval or circular shaped heating element can cover both the eye and both eyelids, wherein the outer boundary of the heating element or strip can follow the path of the upper and lower meibomian glands. In this case, one treatment strip can cover both eyelids and both sets of meibomian glands and the user can use a total of two (instead of four) circular, annular, or oval shaped treatment strips to cover both eyes. Such a variation can be used, for example, for nighttime therapy in bed before or during sleep, when the eyes do not necessarily need to be open.

[0218] Components 332, 334 can generally include strips that conform to the location of the meibomian glands while still allowing the patient to blink easily and comfortably perform daytime activities, as described above. One example of such a heater that can be configured for use with the treatment system 330 can include a thin, flexible heater that is commercially available through companies such as Minco Products, Inc. (Minneapolis, Minnesota) or can be custom designed and manufactured independently or through third-party manufacturing. Each individual treatment strip, such as treatment strips 332A, 332B, can each be sized for a single eyelid, such as 28 mm x 7 mm x 0.15 mm, have a lower chord length of, for example, 28 mm, have a radius of curvature of, for example, 75 mm, and have the general configuration of a curved rectangle with blunt corners where the nasal or temporal edges may coincide with the radius of the curve. However, these size limitations are intended to be exemplary and not limiting, as the treatment strips 332A, 332B may be sized to be smaller or larger to accommodate different eye anatomies.

[0219] In addition, each treatment ribbon 332A, 332B can be formed as a thin, flexible, transparent polymer that houses the heating element, and the contact surface of the ribbon can be secured to the corresponding eyelid using, for example, a disposable adhesive. Other variations can utilize opaque or colored ribbons, such as skin-toned colors. In addition, one or more temperature sensors can also be integrated into the treatment ribbon, where the heating element and sensor can be routed to a power source and / or controller 340 and / or portable electronic device 342 via a connecting cable 338, as shown.

[0220] The controller 340 may generally include a hardware / software platform or unit that can be programmed to control therapy treatment. Accordingly, the controller 340 may include a processor and a power source, such as a battery (rechargeable or disposable), for providing power to the components 332, 334. The power source within the controller 340 may optionally be rechargeable independently of the portable electronic device 342, or the power source may be directly drawn from the portable electronic device 342 to power the components 332, 334 and the processor.

[0221] In the case where the controller 340 is programmed to provide a therapy treatment regimen, one or more controls for controlling the treatment can be built directly into the controller 340. A portable electronic device 342 can interface with the controller 340 to display a portion of the controls, in one variation, on a screen (e.g., a touch screen) of the electronic device 342, such as controls for starting and / or stopping treatment. Alternatively, all of the controls can reside on the controller 340, while the display on the electronic device 342 can be primarily used to display or track various results or treatment parameters.

[0222] In yet another alternative, all of the controls can reside on a display of the electronic device 342 to control various treatment options and parameters, rather than on the controller 340. In this variation, the electronic device 342, in this embodiment a smartphone, can also provide power to the treatment ribbon assemblies 332, 334 and can also control various treatment temperatures and times as well as provide temperature feedback or other physiological parameters that can be measured. In this case, the treatment ribbons 332, 334 and the connecting cable 338 can be directly plugged into the removable or portable consumer electronic device 342. For example, the electronic device 342 can be used to display treatment parameters as well as controls such as an icon or button for starting treatment. In one embodiment, treatment can be initiated by the user via the electronic device 342 to heat one or more of one or both of the treatment ribbon assemblies 332, 334. In either variation, the electronic device 342, particularly in the case of a smartphone or tablet, can have a program or application optionally downloaded to the device that assists in various control units and / or display parameters on the electronic device 342, depending on how the electronic device 342 is used in conjunction with the controller 340 and components 332, 334.

[0223] In addition, the electronic device 342 may also provide diagnostic functionality to allow the user to test for dry eye and / or allow the user to determine how the treatment is progressing before, during, or after treatment. Accordingly, the electronic device 342 or controller 340 may utilize, for example, an integrated camera and / or flash / light source for imaging the tear film or ocular surface of the user's eye and for the purpose of evaluating commonly used tear assessment criteria, such as total 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 imaging the condition of the user's tear film and / or ocular surface, the mobile application may include other commonly used methods for diagnosing dry eye, such as a user questionnaire regarding the user's symptoms, discomfort, and / or improvement or worsening of symptoms that can be completed using the touchscreen interface of the electronic device, with the results stored on the electronic device 342 or web application or manufacturer's server, with trend evaluations tracked over time and potentially shared with the user's physician.

[0224] Furthermore, in any variation, the controller 340 and / or the electronic device 342 can be programmed or initiated to heat the components 332, 334 to, for example, 42.5° C. + / - 1° C. to 2° C. The treatment time can be set to, for example, 15 to 30 minutes, and the controller 340 and / or the electronic device 342 can additionally be programmed to shut down when the allotted treatment time has elapsed or if the measured temperature rises above a predetermined level, such as 45° C. Furthermore, the controller 340 and / or the electronic device 342 can also be programmed or configured to indicate various treatment parameters (e.g., start of treatment, heating element warming, completion of treatment, errors, battery life, etc.) via any number of visual, audible, or tactile indicators.

[0225] In addition, the controller 340 and / or the electronic device 342 can be used to store and / or transmit various data, such as historical treatment data, usage time, total treatment time, temperature data, etc. In addition, the controller 340 and / or the electronic device 342 can communicate wirelessly with a remote server or another controller, allowing the controller 340 and / or the electronic device 342 to be remotely programmable, such as by a physician or another party. In yet other variations, audio and / or visual information (such as advertisements or other media) received from the remote server can also be displayed on the controller 340 and / or the electronic device 342 or various other data can also be transmitted to and / or from the controller 340 and / or the electronic device 342.

[0226] In yet other variations, while the controller 340 is illustrated as being coupled to the components 332, 334 via a wired connection cable 338, other variations may have the controller 340 wirelessly connected to the components 332, 334. Such connection may be via any number of wireless protocols, such as RF, etc.

[0227] This "precision temperature control" mobile heating therapy system can also be used to heat other parts of the body, where the system remains approximately the same, but the heating element size can be varied and the power requirements can also be changed, depending on the total surface area being treated and the temperature target.

[0228] Using a treatment belt incorporating a processor, treatment time or other parameters such as the temperature of the belt can be program-controlled and selectively activated or deactivated, optionally by the patient or automatically. In addition, other parameters such as the frequency of heat delivery or other stimulation can also be program-controlled by the processor to provide additional flexibility in treatment.

[0229] The applications of the devices and methods discussed above are not limited to the treatment of dry eye syndrome, but can include any number of additional therapeutic applications. In addition, such devices and methods can be applied to other treatment sites within the body where acute or chronic inflammation leads to disease or conditions. Therapeutic strips can be custom designed to follow the underlying physiological pathways, such as custom designed and contoured cooling or heating therapeutic strips to treat sinuses and acute or chronic sinusitis, respectively, rhinitis and allergic rhinitis, joint pain and inflammation, arthritis, muscle pain, back pain, headaches, trauma, sports injuries, and the like. Modifications of the components and methods described above for practicing the invention, combinations between different variations (as practicable), and variations of aspects of the invention that are obvious to those skilled in the art are intended to be within the scope of the claims.

Claims

1. A treatment system comprising: an upper band configured to be attached to an area of skin underlying an upper eyelid of a subject, such that the upper band is flexible enough to accommodate movement of the upper eyelid to allow the subject to blink naturally without being constrained by the upper band; a controller in communication with the upper belt via a connecting cable, the connecting cable delivering electrical energy to the upper belt, the controller being programmable for therapeutic therapy, wherein the upper belt is configured to receive the electrical energy and emit thermal energy to the underlying skin area; wherein the upper band has a first curved or arcuate periphery shaped to extend and conform to the boundaries of one or more meibomian glands contained within the underlying skin region, and the upper band further has a second curved or arcuate periphery shaped to extend and conform to the free edge of the upper eyelid; and wherein the upper band is configured to have a contact layer, a heating layer positioned above the contact layer, and an insulating layer positioned on top of the heating layer, and wherein the heating layer is configured to be in thermal communication with the skin area and to emit thermal energy to the skin area.

2. The therapeutic system of claim 1 , further comprising a lower strip configured to be attached to an area of skin beneath the subject's lower eyelid.

3. The therapeutic system of claim 2, wherein the upper ribbon and the lower ribbon are electrically coupled to each other.

4. The therapeutic system of claim 2, wherein the upper ribbon and the lower ribbon are electrically coupled to each other to form a forked rod design.

5. The therapeutic system of claim 1, wherein the upper strip includes a contact surface for placement against the underlying skin area.

6. The therapeutic system of claim 1, further comprising a thermochromic layer in thermal communication with the heating layer.

7. The therapeutic system of claim 1, wherein the controller is coupled to the connection cable.

8. The treatment system of claim 1, wherein the controller is programmed to control one or more parameters of the upper belt.

9. The treatment system of claim 8, wherein the one or more parameters include temperature, treatment time, treatment frequency, or thermal profile of the upper ribbon.

10. The treatment system of claim 8, wherein the controller is programmed to heat the upper belt to a temperature between 40°C and 50°C.

11. The treatment system of claim 8, wherein the controller is programmed to heat the upper belt to a temperature of at most 45°C.

12. The treatment system of claim 8, wherein the controller is programmed to heat the upper belt to a temperature between 40.5°C and 44.5°C.

13. The treatment system of claim 8, wherein the controller is programmed to heat the upper belt to a temperature between 41.5°C and 43.5°C.

14. The treatment system of claim 1, further comprising one or more temperature sensors incorporated into the upper band for regulating the temperature of the upper band.

15. The treatment system of claim 8, wherein the controller is programmed to heat the upper belt for at least ten minutes or more.

16. The treatment system of claim 8, wherein the controller is programmed to heat the upper belt for up to 15 minutes.

17. A therapeutic system comprising: a lower band configured to be attached to an area of skin underlying a lower eyelid of a subject, such that the lower band is flexible enough to accommodate movement of the lower eyelid to allow the subject to blink naturally without being constrained by the lower band; a controller in communication with the lower belt via a connecting cable, the connecting cable delivering electrical energy to the lower belt, the controller being programmable for therapeutic therapy, wherein the lower belt is configured to receive the electrical energy and emit thermal energy to the underlying skin area; wherein the lower band has a first curved or arcuate periphery shaped to extend and follow the boundaries of one or more meibomian glands contained within the underlying skin region, and further has a second curved or arcuate periphery shaped to extend and follow the free edge of the lower eyelid; and The lower band is configured to have a contact layer, a heating layer positioned above the contact layer, and an insulating layer positioned on top of the heating layer, and wherein the heating layer is configured to be in thermal communication with the skin area and to emit thermal energy to the skin area.

18. The therapeutic system of claim 17, further comprising an upper strip configured to be attached to an area of skin underlying an upper eyelid of the subject.

19. The therapeutic system of claim 18, wherein the lower ribbon and the upper ribbon are electrically coupled to each other.

20. The therapeutic system of claim 18, wherein the lower ribbon and the upper ribbon are electrically coupled to each other to form a forked rod design.

21. The therapeutic system of claim 17, wherein the lower strip includes a contact surface for placement against the underlying skin area.

22. The therapeutic system of claim 17, further comprising a thermochromic layer in thermal communication with the heating layer.

23. The therapeutic system of claim 17, wherein the controller is coupled to the connection cable.

24. The treatment system of claim 17, wherein the controller is programmed to control one or more parameters of the lower belt.

25. The treatment system of claim 24, wherein the one or more parameters include temperature, treatment time, treatment frequency, or thermal profile of the lower ribbon.

26. The treatment system of claim 24, wherein the controller is programmed to heat the lower ribbon to a temperature between 40°C and 50°C.

27. The treatment system of claim 24, wherein the controller is programmed to heat the lower ribbon to a temperature of at most 45°C.

28. The treatment system of claim 24, wherein the controller is programmed to heat the lower ribbon to a temperature between 40.5°C and 44.5°C.

29. The treatment system of claim 24, wherein the controller is programmed to heat the lower ribbon to a temperature between 41.5°C and 43.5°C.

30. The treatment system of claim 17, further comprising one or more temperature sensors incorporated into the lower ribbon for regulating the temperature of the lower ribbon.

31. The treatment system of claim 24, wherein the controller is programmed to heat the lower ribbon for at least ten minutes or more.

32. The treatment system of claim 24, wherein the controller is programmed to heat the lower ribbon for up to 15 minutes.

33. A therapeutic system comprising: an upper strip configured to be attached to an area of skin beneath an upper eyelid of a subject having a contact lens-related eye problem in the eye beneath the upper eyelid, such that the upper strip is flexible enough to accommodate movement of the upper eyelid to allow the subject to blink naturally without being constrained by the upper strip while covering one or more meibomian glands contained within the upper eyelid with the upper strip, wherein the upper strip has a first curved or arcuate outer periphery shaped to extend and conform to a boundary of the one or more meibomian glands contained within the upper eyelid and a second curved or arcuate outer periphery shaped to extend and conform to a free edge of the upper eyelid; and a controller in communication with the upper belt via a connecting cable, the connecting cable delivering electrical energy to the upper belt, the controller being programmable for therapeutic therapy, wherein the upper band is configured to receive the electrical energy and emit thermal energy to an upper eyelid on an eye having the contact lens-related eye problem, and wherein the upper band is configured to have a contact layer, a heating layer positioned above the contact layer, and an insulating layer positioned on top of the heating layer, and wherein the heating layer is configured to be in thermal communication with the skin area and to emit thermal energy to the skin area.

34. The therapeutic system of claim 33, further comprising a lower strip configured to be attached to an area of skin underlying a lower eyelid of the subject such that one or more meibomian glands contained within the lower eyelid are covered by the lower strip.

35. A therapeutic system according to claim 34, wherein the lower band has a first curved or arcuate periphery and a second curved or arcuate periphery, wherein the first curved or arcuate periphery is configured to extend and conform to the boundaries of the one or more meibomian glands contained within the lower eyelid and the second curved or arcuate periphery is configured to extend and conform to the free edge of the lower eyelid.

36. The therapeutic system of claim 34, wherein the upper ribbon and the lower ribbon are electrically coupled to each other.

37. The therapeutic system of claim 33, further comprising a thermochromic layer in thermal communication with the heating layer.

38. The therapeutic system of claim 33, wherein the controller is coupled to the connection cable.

39. The treatment system of claim 33, wherein the controller is programmed to control one or more parameters of the upper belt.

40. The treatment system of claim 39, wherein the one or more parameters include temperature of the upper ribbon, treatment time, treatment frequency, or a thermal profile.

41. The treatment system of claim 33, further comprising a display configured to display at least one parameter.

42. The therapeutic system of claim 33, wherein the controller is configured to communicate wirelessly with a remote server.

43. The treatment system of claim 39, wherein the controller is programmed to heat the upper belt to a temperature between 40°C and 50°C.

44. The treatment system of claim 39, wherein the controller is programmed to heat the upper belt to a temperature of at most 45°C.

45. The treatment system of claim 39, wherein the controller is programmed to heat the upper belt to a temperature between 40.5°C and 44.5°C.

46. The treatment system of claim 39, wherein the controller is programmed to heat the upper belt to a temperature between 41.5°C and 43.5°C.

47. The treatment system of claim 33, further comprising one or more temperature sensors incorporated into the upper band for regulating the temperature of the upper band.

48. The therapeutic system of claim 33, wherein the controller is programmed to heat the upper belt for at least ten minutes or more.

49. The therapeutic system of claim 33, wherein the controller is programmed to heat the upper belt for up to 15 minutes.

50. The therapeutic system of claim 33, further comprising a contact lens configured to be positioned on the eye.

51. The therapeutic system of claim 33, further comprising a mechanism configured to mechanically compress the upper eyelid.

52. The therapeutic system of claim 33, further comprising a mechanism configured to impart vibrational energy to the upper eyelid.

53. The therapeutic system of claim 33, further comprising one or more pharmaceutical, biological, or chemical agents infused within or along the upper band.

54. A therapeutic system comprising: a lower strip configured to be attached to the skin area beneath the lower eyelid of a subject having a contact lens-related eye problem in the eye beneath the lower eyelid, such that the lower strip is flexible enough to accommodate movement of the lower eyelid to allow the subject to blink naturally without being constrained by the lower strip while covering one or more meibomian glands contained within the lower eyelid with the lower strip, wherein the lower strip has a first curved or arcuate outer periphery shaped to extend and conform to the boundaries of the one or more meibomian glands contained within the lower eyelid and a second curved or arcuate outer periphery shaped to extend and conform to the free edge of the lower eyelid; and a controller in communication with the lower belt via a connecting cable, the connecting cable delivering electrical energy to the lower belt, the controller being programmable for therapeutic therapy, wherein the lower strip is configured to receive the electrical energy and emit thermal energy to the lower eyelid on the eye having the contact lens related eye problem, and The lower band is configured to have a contact layer, a heating layer positioned above the contact layer, and an insulating layer positioned on top of the heating layer, and wherein the heating layer is configured to be in thermal communication with the skin area and to emit thermal energy to the skin area.

55. The therapeutic system of claim 54, further comprising an upper strip configured to attach to an area of skin underlying an upper eyelid of the subject such that the one or more meibomian glands contained within the upper eyelid are covered by the upper strip.

56. A therapeutic system according to claim 55, wherein the upper band has a first curved or arcuate periphery and a second curved or arcuate periphery, wherein the first curved or arcuate periphery is shaped to extend and conform to the boundaries of the one or more meibomian glands contained within the upper eyelid and the second curved or arcuate periphery is shaped to extend and conform to the free edge of the upper eyelid.

57. The therapeutic system of claim 55, wherein the lower ribbon and the upper ribbon are electrically coupled to each other.

58. The therapeutic system of claim 54, further comprising a thermochromic layer in thermal communication with the heating layer.

59. The therapeutic system of claim 54, wherein the controller is coupled to the connection cable.

60. The treatment system of claim 54, wherein the controller is programmed to control one or more parameters of the lower belt.

61. The treatment system of claim 60, wherein the one or more parameters include temperature of the lower ribbon, treatment time, treatment frequency, or thermal profile.

62. The treatment system of claim 54, further comprising a display configured to display at least one parameter.

63. The therapeutic system of claim 54, wherein the controller is configured to communicate wirelessly with a remote server.

64. The treatment system of claim 60, wherein the controller is programmed to heat the lower ribbon to a temperature between 40°C and 50°C.

65. The treatment system of claim 60, wherein the controller is programmed to heat the lower ribbon to a temperature of at most 45°C.

66. The treatment system of claim 60, wherein the controller is programmed to heat the lower ribbon to a temperature between 40.5°C and 44.5°C.

67. The treatment system of claim 60, wherein the controller is programmed to heat the lower ribbon to a temperature between 41.5°C and 43.5°C.

68. The treatment system of claim 54, further comprising one or more temperature sensors incorporated into the lower ribbon for regulating the temperature of the lower ribbon.

69. The therapeutic system of claim 54, wherein the controller is programmed to heat the lower ribbon for at least ten minutes or more.

70. The treatment system of claim 54, wherein the controller is programmed to heat the lower ribbon for up to 15 minutes.

71. The therapeutic system of claim 54, further comprising a contact lens configured to be positioned on the eye.

72. The treatment system of claim 54, further comprising a mechanism configured to mechanically compress the lower eyelid.

73. The treatment system of claim 54, further comprising a mechanism configured to impart vibrational energy to the lower eyelid.

74. The therapeutic system of claim 54, further comprising one or more pharmaceutical, biological, or chemical agents injected within or along the lower ribbon.

75. A therapeutic assembly comprising: a first treatment portion positionable on the skin of a user above the lower eyelid; a second treatment portion positionable on the skin beneath the user's upper eyelid; and a connector between the first treatment portion and the second treatment portion, wherein energy is capable of being delivered from the first treatment portion to the skin above the lower eyelid, wherein energy is capable of being delivered from the second treatment portion to the skin beneath the upper eyelid, and Wherein the first treatment portion and / or the second treatment portion is configured to have a contact layer, a heating layer positioned above the contact layer and an insulating layer positioned on top of the heating layer, and wherein the heating layer is configured to be thermally connected to the skin area and emit thermal energy to the skin area.

76. The therapeutic assembly of claim 75, further comprising a gap between the first treatment portion and the second treatment portion, wherein the connector extends through the gap.

77. The therapeutic assembly of claim 75, wherein the connector extends from a lateral end of the first therapeutic portion.

78. The therapeutic assembly of claim 75, wherein the first therapeutic portion and the connector lie in the same plane.

79. The therapeutic assembly of claim 75, wherein the first therapeutic portion and the second therapeutic portion are coupled to the connector.

80. The therapeutic assembly of claim 75, wherein the connector is narrower than the first treatment portion.

81. The therapeutic assembly of claim 80, wherein the connector is narrower than the second therapeutic portion.

82. The therapeutic assembly of claim 75, wherein the first therapeutic portion, the second therapeutic portion, and the connector are positionable on the left side of a user's face or on the right side of a user's face.

83. A therapeutic assembly comprising: a first ribbon, a second ribbon, and a connector, wherein the first strip is capable of being placed on the eyelid of a subject, wherein energy is capable of being delivered to the eyelid via the first ribbon, wherein the second ribbon is located between the first ribbon and the connector, and Wherein the first ribbon is configured to have a contact layer, a heating layer positioned above the contact layer, and an insulating layer positioned on top of the heating layer, and wherein the heating layer is configured to be in thermal communication with the skin area and to emit thermal energy to the skin area.

84. The therapeutic assembly of claim 83, wherein the second ribbon comprises a controller.

85. The therapeutic assembly of claim 83, further comprising a controller, wherein a thermal parameter of the first ribbon is controllable by the controller.

86. The therapeutic assembly of claim 83, wherein the first ribbon has a first ribbon width, wherein the connector has a connector width, and wherein the first ribbon width is greater than the connector width.

87. The therapeutic assembly of claim 83, wherein the first ribbon has two curved edges, and wherein the second ribbon has two curved edges.

88. The therapeutic assembly of claim 83, wherein the first ribbon has a straight edge and a curved edge, and wherein the second ribbon has two curved edges.

89. The therapeutic assembly of claim 83, wherein the first ribbon has two curved edges, and wherein the second ribbon has a straight edge and a curved edge.

90. The therapeutic assembly of claim 83, wherein the first ribbon has a straight edge and a curved edge, and wherein the second ribbon has a straight edge and a curved edge.

91. The therapeutic assembly of claim 83, wherein when the first ribbon is placed on the eyelid, the first ribbon, the second ribbon, and the connector are all closer to the subject's first eye than to the subject's second eye.

92. A therapeutic assembly comprising: a first ribbon, a second ribbon, and a first connector extending from the first ribbon, wherein the first strip is positionable on a first skin portion on a first side of a first eye of a subject, wherein the second strip is positionable on a second skin portion on the first side of the first eye of the subject, and wherein energy is deliverable to the first skin portion via the first ribbon, and Wherein the first ribbon is configured to have a contact layer, a heating layer positioned above the contact layer, and an insulating layer positioned on top of the heating layer, and wherein the heating layer is configured to be in thermal communication with the skin area and to emit thermal energy to the skin area.

93. The therapeutic assembly of claim 92, further comprising a second connector and a third ribbon.

94. The therapeutic assembly of claim 93, wherein energy is deliverable through the third ribbon, and wherein when the first ribbon is positioned on the first skin portion, the first ribbon, the second ribbon, and the first connector are each closer to the first eye of the subject than to the second eye of the subject.

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