Forceps treatment system

Abstract

To provide a forceps treatment system.SOLUTION: A forceps device, in general, may include a first handle and a second handle coupled to each other in the vicinity of each proximal end or at each proximal end. A first paddle may be coupled to the first handle and define a first inner surface, and a second paddle may be coupled to the second handle, and define a second inner surface arranged side by side with the first inner surface. Furthermore, a debriding member may define a debriding end for a debriding member to extend in a proximal direction from the first and second handles, contract and gradually bend, approach one or a plurality of meibomian glands, and debride a tissue. The forceps device may be used in combination with heat treatment for treating one or a plurality of meibomian glands of a subject.SELECTED DRAWING: Figure 11D

Description

[Technical field]

[0001] The present invention relates to methods and devices for treating dry eye syndrome and other related conditions. More particularly, the present invention relates to methods and devices for treating various eye-related conditions, such as dry eye syndrome, using forceps configured for expression and debleeding of obstructions of the meibomian glands, as well as adhesive strips having special contours or shapes for adhering to selected areas around a patient's eye and periorbital area. [Background technology]

[0002] Tears are a complex mixture of water, lipids, mucus, proteins, and electrolytes that help maintain a smooth, lubricated, and optically clear optical surface, and also help protect the eye from infection. There are three basic layers to the tear film: oil, water, and mucus, and problems or disruptions to any of these layers can lead to ocular surface problems, including dry eye symptoms.

[0003] The outermost layer of the tear film is usually composed of an oily layer (meibom) containing fatty acids and lipids, which is produced by sebaceous glands called meibomian glands, located mainly along the margins of the eyelids. The oily layer lubricates the surface of the tears and prevents the aqueous or water-containing middle layer from evaporating. However, if the meibomian glands do not secrete enough oil, produce a suboptimal fatty acid mixture, or are blocked or clogged, the aqueous layer typically evaporates faster, resulting in dry eye. Blockage or inflammation of the meibomian glands can lead to enlargement and infection of the glands, thickening of secretions, styes, chalazions, styes, and preorbital cellulitis. Thus, dry eye is often seen in people with impaired or impaired functioning meibomian glands. The above example is an example of meibomian gland dysfunction, also known as evaporative dry eye.

[0004] The middle aqueous layer of tears is composed mainly of aqueous solutions and is produced by the lacrimal gland and its accessory glands (lacrimal glands). The middle layer cleanses the eye, washing away foreign bodies and irritants, maintains a clear optical medium, and keeps the ocular surface moist. The innermost layer of the tear film is composed mainly of mucus, which helps to spread the tears evenly over the surface of the eye. A lack of mucus in the tear film can lead to dry eye syndrome.

[0005] As mentioned above, meibomian glands are oil-secreting glands found in both the upper and lower eyelids. There are approximately 30-40 meibomian glands in the upper eyelid and 20-30 in the lower eyelid, with each gland having a duct along the inner side of the free edge of the corresponding eyelid through which the secretions are released to prevent adhesion between the eyelids and the ocular surface. An example of the location of the meibomian glands is shown in the cross-section of the upper eyelid UL shown in Figure 1A, which shows the relative location of a single meibomian gland MG. Other glands and anatomical features are illustrated for reference, such as the Wolfring's gland GW, tarsal plate TR, Moll's gland GM, Zeiss's gland GZ, Krause's gland GK, upper fornix UF, conjunctiva CN, and cornea CR of the eye that is partially covered by the upper eyelid UL. As shown, the meibomian glands MG are located along the length of the upper eyelid UL (and lower eyelid LL), with the openings of the ducts along the inner edge of the eyelid UL close to the underlying ocular surface.

[0006] FIG 1B is a front view of a patient's eye with the upper eyelid UL and lower eyelid LL closed, as when the patient blinks. As shown, the meibomian glands MG can be seen in both the upper eyelid UL and the lower eyelid LL, adjacent to each other and aligned. FIG 1C is a perspective view of the patient's eye open, showing how the meibomian glands are aligned relative to each other when the patient's eye is open.

[0007] Blinking is believed to be the primary mechanism for opening the orifices of the meibomian glands and generating compressive forces to release oily secretions from the glands. The natural blinking action and force of blinking causes the upper eyelid to pull and drag the sheet of lipids secreted by the meibomian glands onto the two lower layers of the tear film, forming a protective layer that limits the rate of evaporation of the lower layers. It is estimated that at least 65% of meibomian gland disease and dry eye are due to defects in the lipid layer, or an insufficient amount of such lipids, which enhances evaporation of the aqueous layer. Therefore, impaired eyelid closure or blinking, or other disorders that affect the proper distribution of tears, may also cause or exacerbate meibomian gland dysfunction and dry eye.

[0008] When the eyelids close to complete a blink, the upper and lower fornix, which are the tear reservoirs, are compressed by the force of the frontalis muscle, and the eyelids move towards each other. For example, the upper eyelid moves over the eye, exerting a force on the surface of the eye, clearing debris and insoluble mucin from the front of the eye, and also expressing oil secreted by the meibomian glands. The lower eyelid moves horizontally towards the nose, pushing debris towards both puncta, the openings that ultimately drain into the nasal cavity.

[0009] When the eyelids open, the tear film is redistributed, the upper eyelid attracts the aqueous phase by capillary action, and the lipid layer spreads rapidly with the eyelid movement, so eyelid movement plays an important role in tear film regeneration, distribution, turnover, and drainage.

[0010] For a variety of reasons, the meibomian glands can become blocked, clogged, inflamed, or obstructed, resulting in meibomian gland dysfunction and dry eye. The obstruction that causes disease can occur anywhere within the gland, such as at the surface or orifice of the gland preventing the flow of normal lipid secretions, at a narrowing or blockage of the main flow passage of the gland, or elsewhere deep within the gland that connects to the main flow passage.

[0011] There are many conventional therapies for treating clogged meibomian glands. One course of treatment is application of soaps and cleansers, eyelid scrubs, disinfectants, or antibiotics to reduce eyelid inflammation. Oral or topical antibiotics such as tetracycline, doxycycline, minocycline, metronidazole, azithromycin, bacitracin, and erythromycin can help regulate or improve meibomian gland lipid production. Ocular surface inflammation can also be controlled with topical medications such as corticosteroids and cyclosporine (RESTASISR®, Allergan, Inc, CA), as well as other anti-inflammatory compounds and immunosuppressants. Evidence suggests that ocular surface inflammation is associated with meibomian gland dysfunction as well as dry eye syndrome.

[0012] Other examples of dry eye treatments include the application of prescription ocular inserts for people with moderate to severe dry eye symptoms who cannot use artificial tears. Ocular inserts, such as hydroxypropylcellulose (LACRISERT®, Merck & Co. Inc, NJ), may be inserted between the lower eyelid and the eye. The insert slowly dissolves, releasing substances that lubricate the eye. Alternatively, special contact lenses or amniotic membrane implants may be used to seal the surface of the eye and trap moisture.

[0013] Other treatments include inserting punctal plugs into the tear ducts or cauterizing the drainage tissue to close the patient's tear ducts so that the tear film does not drain as quickly from the eye surface. In addition to implants and cauterization, medicines such as eye drops and ointments that coat the eyeball may also be used to treat dry eye syndrome. Artificial tears, gels, ointments, autologous serum tears, and albumin eye drops are all used to treat dry eye.

[0014] In addition, hot compresses can be placed on the eyes to dissolve the lipid plugs and restore meibomian gland function, while eyelid massage can further reduce the sense of blockage and drain the contents of the meibomian glands. However, hot compresses must be applied two to three times a day, during which the patient may accidentally target only one affected eyelid, preventing the patient from seeing the treated eye due to the application of the hot compress. Hot compresses have multiple problems, including non-compliance, poor persistence, and high variability. In addition, the compress may be too hot, worsening inflammation, or too cold, resulting in insufficient therapeutic effect.

[0015] Devices have also been developed that apply heat and massage forces directly to the affected eyelids, covering the entire affected eye. However, such devices, like compresses, require the patient's eyes to be completely blocked, albeit temporarily, during treatment, which can lead to discomfort, reduced productivity, and reduced compliance among patients. In addition, these treatments require a visit to a physician or health care provider, making them time-consuming, inconvenient, and expensive, and as a result, they are not suitable for widespread consumer adoption.

[0016] There are also forceps used for meibomian gland expression, but these forceps are not customized or optimized for meibomian gland expression, which typically involves applying a compressive force to the gland to express the gland's secretion, called meibum, from the gland's orifice. For example, such forceps are not heated and are not customized with dimensions for directional expression of the meibom.

[0017] Thus, there is a need for methods and devices that are relatively easy for a patient or physician to use on a daily basis, that allow the patient to continue with their normal activities, that are unobtrusive and unobtrusive, and that utilize the patient's natural physiological activity to facilitate treatment and expression of the meibomian glands. Summary of the Invention [Problem to be solved by the invention]

[0018] In treating conditions such as meibomian gland dysfunction (MGD), commonly associated with evaporative dry eye syndrome (DES), the meibomian glands may be mechanically pressed or squeezed to release hardened meibum from the glands to aid in the treatment of MGD. Forceps are used to apply pressure to the meibomian glands, usually in combination with heat treatment. Forceps may also be used to debride tissue along the upper and lower eyelid margins to remove internal or external obstructions, keratinization, or "capping" at or near the orifices of the meibomian glands. Additionally, the described therapeutic methods may be used for other procedures as well, such as improved vision, improved contact lens comfort, improved tear quality, and improved surgical outcomes due to improved tear quality and precise measurements from optical surfaces. [Means for solving the problem]

[0019] With respect to the assembly of one or more treatment strips, the assembly includes one or more strips configured to adhere to an underlying layer of skin adjacent one or both eyes of a subject, the one or more strips allowing the subject to blink naturally without being constrained by the one or more patches. Additionally, the one or more strips may be configured to deliver energy or treat the underlying layer of skin, the one or more strips configured to conform to the location of one or more meibomian glands contained within the underlying layer of skin.

[0020] A programmable controller having a controller board and processor may be in communication with the strip or strips, and the controller may induce and monitor the programmable temperature of the heater strip or strips and provide a treatment therapy. The therapy may be programmed to maintain a set point (e.g., 42°C ± 1°C) greater than a threshold temperature (e.g., 39°C) and less than a maximum temperature (e.g., 48°C) within a known accuracy range during a treatment period of, for example, 15 minutes. Other treatment times may be implemented in other treatment variations. For example, in other treatment variations, the treatment time may extend from 1 minute to 60 minutes.

[0021] In use, one or more strips may be adhered to an area of ​​skin proximate one or both eyes of a subject such that the one or more strips allow the subject to blink naturally without being restricted by the one or more patches. When adhered, the strips may treat or emit energy to the area of ​​skin, with the one or more strips shaped to conform to the location of one or more meibomian glands contained in the area of ​​skin. Alternatively, the strips may not directly cover the meibomian glands or other orbital glands, but may instead provide or absorb energy from adjacent underlying tissue or vasculature, and ultimately diffuse or provide energy to these glands. That is, the strips may be used to heat or cool the blood supply to the eyelids, meibomian glands, and / or lacrimal glands, which may affect their function and metabolism, without necessarily directly overlaying them in certain variations. For example, the strips may heat or cool by any modality of heat transfer, such as radiation, conduction, convection, or any combination thereof, without directly overlaying the tissue.

[0022] Thus, the upper strip may have an upper curved or arcuate periphery that extends along the upper (or upper) border of the meibomian glands (e.g., along or up to the upper eyelid crease), while the lower straightened periphery extends along the free edge of the upper eyelid and along the lower (or lower) border of the meibomian glands. Although straight, in another variation, the lower end may be gently curved or arcuate. The lower strip may similarly have an upper straight periphery that extends and follows the upper (or upper) border of the meibomian glands along the free edge of the lower eyelid, and a lower curved or arcuate periphery that extends along the lower eyelid and along the lower eyelid (e.g., along or up to the lower eyelid crease). Alternatively, the upper periphery of the lower strip may be gently curved or arcuate in a similar manner in another variation.

[0023] That is, for a tarsal plate that includes the meibomian glands from proximal to distal, the peripheral edge of the treatment strip corresponds to the distal lid margin and proximal peripheral edge, and the treatment strip can have a number of configurations. In general, the peripheral distal edge of the treatment strip can be relatively straight or assume a gentle curve, either of which can conform to the underlying distal lid margin and tarsal plate, with a relatively curved proximal peripheral edge that assumes the more curved proximal end of the underlying tarsal plate.

[0024] The strips can be used individually for placement on just the upper eyelid or just the lower eyelid, depending on the treatment desired. Furthermore, the length of the treatment strip can be varied, if desired, to provide targeted treatment to individual meibomian glands, as described in more detail herein. Additionally, the treatment strips can be of a generic size or can be custom made or sized to fit the eyelid dimensions of a particular individual.

[0025] The contoured size and flexibility of the treatment strip allows the treatment strip to be placed on the patient to provide treatment to the underlying meibomian glands, allowing the patient's eyes to open and close normally without interference from one or both treatment strips. Thus, the contoured size, shape, thickness, and flexibility of the treatment strip allows the patient to hold one or both eyes open while the treatment is being performed, allowing normal, physiological blinking during the treatment. To further reduce the forces on the eyelids, multiple turns (e.g., nonlinear regions) can be added to the heater connection path to decouple the heater from the forces on the connections (e.g., wires) and to destabilize the load transmitted from the power cable to one or more eyelids. Rather than relying on the application of any kind of external force, the treatment strip takes advantage of the eye's natural mechanism for clearing oil from the meibomian glands by blinking. Thus, the treatment strips can be adhered in place for treatment without further intervention by the patient or medical practitioner, and the treatment strips can apply, for example, thermal energy to melt or liquefy waxy or solid meibomian gland obstructions while the eye remains unobstructed and allows for natural blinking. Unlike other treatments that require the patient to close their eyes or refrain from blinking during the treatment process, the treatment strips use the force of natural blinking to clear the heat-softened obstruction from the gland before it can re-harden, preventing or inhibiting the patient from blinking.

[0026] The forceps may be used in combination with the heating strips described herein before, after, and / or during the heating process. Alternatively, the forceps may be used to first heat the gland to melt the meibomian plug contained therein, and then the forceps may be used to mechanically express the liquefied meibom before it resolidifies. The two juxtaposed handles of the forceps each terminate at a distal end with a corresponding paddle, and the proximal end of the forceps includes a proximally extending debridement member that may define a curved or arcuate debridement edge at its periphery. To facilitate positioning of the paddle relative to the tissue region of the eye to be mechanically expressed, the paddle may be angled along its length to define an angle relative to the longitudinal axis of the forceps.

[0027] The debleeding member may extend from the proximal end of the forceps and define a relatively thin end relative to the rest of the forceps. In one variation, the debleeding member may have a length that is reduced and gently curved, for example, oval. In use, the paddle may be used to directly mechanically express the meibomian glands and / or apply pressure to tissue areas proximate the meibomian glands, while the debleeding end may be used to scrape along the upper and / or lower eyelid margins to remove obstructions, keratin, membranes, debris, or capping from or over the meibomian glands and meibomian gland orifices before, during, and / or after mechanical expression. Additionally, mechanical expression and / or debleeding with the forceps may occur at any time during heat treatment with one or more heating strips and in any treatment sequence. For example, the upper and / or lower eyelids may be thermally treated with one or more heating strips for a period of time, and then the upper and / or lower eyelids may be mechanically expressed with forceps, and debridement may be performed with the debridement end after, during, and / or before the thermal treatment. Alternatively, the tissue may be debridement with the debridement end before, during, and / or after the thermal treatment with or without mechanical expression, or only mechanical expression may be performed without the debridement end. In other variations, the tissue may first be debridement with the debridement end and then thermal treatment with the treatment strip. The debridement procedure may be performed with or before the patient wears the treatment strip. The meibomian glands may then be mechanically expressed with forceps. The mechanical expression may be performed with or after the patient wears the treatment strip. Depending on the desired results, different combinations of procedures may be performed.

[0028] In one variation, the forceps device may generally include a first handle and a second handle coupled to one another near or at their respective proximal ends, a first paddle coupled to the first handle and defining a first inner surface, a second paddle coupled to the second handle and defining a second inner surface disposed opposite the first inner surface, and a debleeding member extending proximally from the first and second handles and gently constricting and curving to define a debleeding end for debriding tissue proximate one or more meibomian glands. In other variations, the forceps may be configured with the first and / or second paddles having one or more of their ends modified to not only provide mechanical expression but also function as a debleeding end.

[0029] In another variation, the forceps device generally includes a first handle and a second handle coupled to one another near or at their respective proximal ends, a first paddle coupled to the first handle and defining a first inner surface, and a second paddle coupled to the second handle and defining a second inner surface positioned opposite the first inner surface, wherein the first paddle and / or the second paddle can define a debriding end along a distal or proximal end for debriding tissue adjacent one or more meibomian glands.

[0030] In one method of treating a subject, the method generally includes the steps of debriding tissue or debris adjacent one or more meibomian glands in a tissue region of the subject with a debridement member extending proximally from a forceps having a first handle and a second handle coupled to one another near or at their respective proximal ends, subjecting the one or more meibomian glands to a thermal treatment, and mechanically expressing the one or more meibomian glands with a first paddle coupled to the first handle and defining a first inner surface and a second paddle coupled to the second handle and defining a second inner surface positioned opposite the first inner surface.

[0031] Additionally, the forceps variations and combinations described herein may be used alone for the treatment of a patient or in combination with any of the treatment apparatus and methods described in U.S. Patent Nos. 9,724,230, 9,510,972, 9,844,459, 9,642,743 and U.S. Patent Application Publication Nos. 2016 / 0106576, 2017 / 0165106, 2017 / 0304110, and 2017 / 0087009, each of which is incorporated by reference in its entirety and for any purpose herein, particularly for the treatment of MGD and dry eye syndrome. [Brief description of the drawings]

[0032] [Figure 1A] FIG. 1A shows a cross-sectional side view of the upper eyelid and an example of the location of the meibomian glands. [Figure 1B] FIG. 1B is a front view showing the distribution of meibomian glands in a human eyelid with the upper and lower eyelids closed, such as when a patient blinks, and the arrangement of the meibomian glands across both the upper and lower eyelids. [Figure 1C] FIG. 1C is a perspective view of the patient's open eye, illustrating the relative alignment of the meibomian glands when the patient's eye is open. [Figure 2A] FIG. 2A is a front view of a patient's eye in a closed position showing an example of a treatment strip that adheres to the upper or lower eyelid (or both), with the strip sized or contoured to be placed directly over the meibomian gland in the lower eyelid. [Figure 2B] Figure 2B shows the treatment strip of Figure 2A and illustrates how the strip adheres to the patient's skin while retracting the eyelid, allowing the patient to continue blinking while looking normally through the eye. The strip is applied from the eyelid margin to the eyelid crease, but may alternatively bend or accordion and / or compress during blinking to prevent interference with normal blinking and maximize comfort. [Diagram 3]FIG. 3 illustrates yet another variation of an eyelid treatment system coupled to a handheld remote control, such as a smartphone or tablet. [Figure 4] FIG. 4 is a perspective view of a control specially designed and programmed for use with a treatment strip assembly. [Figure 5A] FIG. 5A is a perspective view of a control having a connector for a processing strip assembly coupled to the control. [Figure 5B] FIG. 5B is a perspective view of a control with a connector for a processing strip assembly coupled to the control. [Figure 6] FIG. 6 illustrates a mating connection between the treatment strip assembly and the reusable cable assembly. [Figure 7A] FIG. 7A is a perspective view of treatment strip assemblies coupled via respective connectors to a common junction for attachment to a cable. [Figure 7B] FIG. 7B is a perspective view of a processing strip with the sensing layer exposed, showing the locations of the various sensors. [Figure 8] FIG. 8 is a perspective view of one variation of the forceps of the present invention, the size and angle of which are intended to expose the meibomian glands. [Figure 9] FIG. 9 shows an example of a treatment kit including forceps and, optionally, additional treatments. [Figure 10A] FIG. 10A shows another example of a treatment kit that includes forceps and one or more heating strips. [Figure 10B] FIG. 10B shows another example of a treatment kit including forceps, one or more heating strips, and optionally a control unit. [Figure 10C] FIG. 10C illustrates yet another example of a treatment kit including a forceps, and optionally includes one or more heating strips, controls, and / or additional treatments. [Figure 11A] FIG. 11A is a top view of another variation of a forceps having a debridement function. [Figure 11B]FIG. 11B is a side view of another variation of a forceps having a debridement function. [Figure 11C] FIG. 11C is an end view of another variation of a forceps having a debridement function. [Figure 11D] FIG. 11D is a perspective view of another variation of a forceps having a debridement function. [Figure 12A] FIG. 12A is a detailed side view of a forceps paddle. [Figure 12B] FIG. 12B is a detailed side view of another variation of a paddle having one or more debridement edges. [Figure 13A] FIG. 13A is a side view of the debridement feature. [Figure 13B] FIG. 13B is an end view of the debridement feature. [Figure 14] FIG. 14 is a perspective view of a debridement feature for removing obstructions of the meibomian glands. [Figure 15A] FIG. 15A is a detailed side view of a different variation of debridement features provided along the cutout portion. [Figure 15B] FIG. 15B is a detailed side view of a different variation of debridement features provided along the cutout portion. [Figure 15C] FIG. 15C is a detailed side view of a different variation of debridement features provided along the cutout portion. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0033] In treating conditions such as meibomian gland dysfunction (MGD), commonly seen in evaporative dry eye syndrome (DES), the meibomian glands may be mechanically pressed or squeezed to expel hardened meibum from the glands to aid in the treatment of MGD. Forceps are typically used to apply pressure to the meibomian glands. The forceps can be modified to create a pressure gradient on the meibomian glands to direct the meibom and any other meibomian gland secretions to the orifices of the meibomian glands. The forceps may be configured to further debride tissue along the upper and / or lower eyelids to facilitate removal of obstructions such as concentrated oils and meibomian plugs from the openings of the main ducts and orifices of the meibomian glands, the meibomian gland channels, and the meibomian gland orifices. Additionally and / or alternatively, the forceps may be configured to apply, for example, a heat treatment to the surface of the eyelid to simultaneously melt and soften or liquefy and express the meibom to enhance the therapeutic effect.

[0034] Forceps can be used in combination with the heating strips described herein before, during, and / or after the heat treatment. Alternatively, the forceps can be used to first apply heat to dissolve the meibomian plug contained within the gland, and then the forceps can be used to mechanically express the liquefied meibom before it resolidifies. Alternatively, the forceps can be used to simultaneously apply heat and mechanical expression, effectively expressing the meibom. In treating the meibomian glands, the forceps can also be used to apply heat to other sites, such as the inner eyelid, the outer eyelid, or both. However, when heating strips are used to administer heat to a patient, the forceps used to mechanically express the gland can be configured to heat the gland separately and / or can include any number of mechanical features as described herein to facilitate mechanical expression.

[0035] For the treatment of conditions such as meibomian gland dysfunction (MGD), which is a cause of evaporative dry eye syndrome (DES), patches, strips, or thin adhesives can be applied to the skin of the upper and / or lower eyelids to transmit or absorb (alone or in combination) heat or other forms of energy, pressure, medication, moisture, etc., to one or more meibomian glands in the skin underneath. In particular, one or more treatment strips are configured and specifically sized for placement over one or more targeted meibomian glands in the skin of the upper and / or lower eyelids. The eyelids are generally the thinnest skin in the human body, and the tissue is highly vascularized, so that thermal therapies such as heat and cold can be applied quite easily through the eyelids. Because the base of the eyelid is located proximally and the edge of the eyelid is located distally, the net flow of arterial blood is from proximal to distal. Therefore, no matter where these treatment strips are placed, heat or cold therapy is readily delivered to the eyelid and any structures contained therein, such as the meibomian gland MG, lacrimal gland LG, Zeiss gland GZ, Moll's gland GM, Wolffing's gland GW, Krause's gland GK, etc.

[0036] Additionally, the eyelids are very thin, allowing the heat or cold therapy to be delivered to the ocular surface and the eye itself (more on this below). Thus, therapy can also energize the conjunctiva, goblet cells, episcleral vasculature, cornea, aqueous humor, iris, ciliary body, and potentially the retina, choroid, optic nerve, anterior vitreous, lens, etc. In this manner, any heat therapy with a therapeutic strip can also affect and be used to treat ocular surface and anterior segment diseases, such as conjunctivitis, keratitis, keratopathy, iritis, cyclitis, glaucoma, cataract, etc. Also contemplated for use in post-operative conditions, such as after LASIK, PRK, cataract or corneal surgery, or other ocular, periocular, intraocular, or lid surgery, as described in more detail below.

[0037] As shown in the front view of Figures 2A and 2B, one variation of such treatment strips may be seen to be temporarily adhered to the upper eyelid UL and lower eyelid LL on the closed eye of a patient P for illustrative purposes. The contoured upper strip 10 may be sized to be adhered directly onto the skin of the upper eyelid UL such that the strip 10 has a configuration and shape that follows the location of one or more meibomian glands contained within the underlying skin of the upper eyelid UL. Similarly, the contoured lower strip 12 may have a configuration and shape that follows the location of one or more meibomian glands contained within the underlying skin of the lower eyelid LL. In other variations, the contoured strips may stop at or cross over the eyelid crease, as described in other variations below.

[0038] Thus, the upper strip 10 may have an upper curved or arcuate periphery 14 configured to extend along the upper (or upper) border of the meibomian glands (e.g., along the upper eyelid crease or up to the upper eyelid crease), while the lower straightened periphery 16 may be configured to extend along the lower (or lower) border of the meibomian glands, such as along the free edge of the upper eyelid UL. The lower strip 12 may similarly have an upper straightened periphery 20 configured to extend along the upper (or upper) border of the meibomian glands along the free edge of the lower eyelid LL, and a lower curved or arcuate periphery 18 configured to extend along the lower (or lower) border of the meibomian glands along the lower eyelid LL (e.g., along the lower eyelid crease or up to the lower eyelid crease). As used herein, the use of the terms lower and upper refer to the periphery of the treatment strip when placed on a patient P (human or animal) and are used herein for descriptive purposes.

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

[0040] Although the treatment strips 10, 12 are shown placed over the closed eyelids of a patient P, the strips 10, 12 may be sufficiently arcuate or flexible to assume the curvature of the patient's lid margin and may be of sufficient length to cover some or all of the meibomian glands beneath the tarsal plate. The treatment strips 10, 12 may be of a generic size, but may also be custom made or sized to fit the dimensions of a particular individual's eyelid and shaped to optimize adhesion and / or comfort and / or stability. Generally, the treatment strips 10, 12 may have a length anywhere from about 1 mm to 50 mm, depending on the patient's anatomical considerations along with the desired treatment length, as a typical palpebral fissure in an adult is approximately 27 mm to 30 mm in length. Thus, to cover as many of the meibomian glands as possible, the treatment strips 10, 12 may be sized to have lengths of, for example, 25 mm to 30 mm, or, if sized to cover just beyond all of the meibomian glands, may be sized to have lengths of, for example, 30 mm to 50 mm (or more, if needed to optimize coverage / adhesion / comfort / stability). Additionally, one or both of the treatment strips 10, 12 may have widths ranging from about 1 mm to 25 mm (or more, if needed, for adhesion / comfort and potentially to enhance the effect of heating or cooling the incoming blood flow) since the typical eyelid crease for Caucasian males is about 8 mm to 9 mm above the eyelid margin, and for Caucasian females is about 9 mm to 11 mm above the eyelid margin). Customization allows for use according to body size, race, ethnicity, etc. Additionally, the treatment strips can be manufactured with varying levels of flexibility to accommodate the ergonomics of the eyelid and eyelid blinking to optimize comfort and minimize discomfort or movement.

[0041] Because of the particular contoured size and flexibility of the treatment strips 10, 12, the treatment strips may be worn by a patient P for their own consumer use or by a healthcare professional to administer treatment to the underlying meibomian glands, and the patient's eyes may be opened and closed normally, as shown in Figure 2B, without interference from one or both treatment strips. The strips are applied from the lid margin to the lid crease, but may alternatively expand or accord and / or compress during blinking to prevent interference with normal blinking and maximize comfort.

[0042] Typical treatment patches, such as hot compresses, are generally sized to be placed over one or both eyes so that the patient cannot open or blink during the treatment session. However, because there is a strong association between DES and MGD (e.g., MGD includes the spectrum of MGD, meibomianitis, blepharitis, and ophthalmic rosacea), an individual's natural blinking is usually the mechanism by which meibomian gland secretions are released onto the eyelid margin and onto the tears. In the absence of blinking, the oil contained in the meibomian glands is not expressed within the terminal ducts of the glands and does not contribute to the distribution of the oily layer over the tears.

[0043] Thus, the contoured size, shape, and flexibility of the treatment strips 10, 12 allow the patient to keep one or both eyes open while the treatment is being performed, allowing the patient to perform normal, physiological blinking during the course of the treatment. The treatment strips 10, 12 utilize the eye's natural mechanism of expelling oil from the meibomian glands by blinking, rather than relying on the application of any external force to expel the oil and obstructions from the glands. Thus, the treatment strips 10, 12 may be adhered in place for treatment without further intervention by the patient or healthcare provider, where the treatment strips 10, 12 may apply, for example, thermal energy to melt or liquefy waxy or solid meibomian gland obstructions while the eye remains unobstructed and able to blink naturally. In this way, the treatment strips 10, 12 allow for natural blinking, which helps to remove heat-treated, softened obstructions from the glands before resolidifying, unlike other treatments where the patient must close or have obstructions during treatment to prevent or inhibit the patient from blinking. The provision of heat may also promote vasodilation and increase blood flow, which can affect metabolism and the temperature of other tissues or affect inflammation, thereby promoting tissue function and repair.

[0044] Because some patients have obstructions or blockages in the meibomian glands that may not adequately melt, loosen, or soften without achieving high temperatures in the meibomian glands, the treatment strips 10, 12 may remain on the patient for any period of time throughout the day, allowing the treatment strips 10, 12 to apply heat or other treatments to the surface of the eyelids for a significant period of time at relatively long treatment times and high treatment temperatures. The treatment strips may be relatively clear or flesh-colored, and therefore unnoticeable, to function normally throughout the treatment area. The patient may go about their daily life with the comfort of treatment with the strips, with their eyes open and blinking. Furthermore, the patient may apply the treatment strips as many times as necessary, such as for a day, a week, or a month, until the dry eye symptoms subside. This may increase the frequency and convenience of treatment, and therefore the effectiveness of treatment.

[0045] Due to the extended treatment time, it may not be necessary to apply a separate force beyond the application of the strips, as long as the patient is able to continue blinking throughout the course of treatment. Furthermore, the frequency of treatments can be adjusted or varied depending on the severity of the condition being treated. An example of a potential treatment frequency would include application of one or both strips, for example, up to six times per day for 10 minutes of treatment, or up to one hour or more per treatment. Furthermore, because the treatment strips are positioned over the meibomian glands, which overlie the ocular surface, application of heat therapy may also indirectly heat the ocular surface, further reducing any chronic ocular surface inflammation, chronic conjunctival inflammation, or corneal neovascularization.

[0046] It is also possible to use thermotherapy not only to heat the ocular surface, but potentially to heat the retina indirectly from the ocular surface to inhibit inflammation and neovascularization that underlie diseases such as age-related macular degeneration (AMD), retinal vascular occlusion, retinal neovascularization, glaucoma, retinal degeneration, retinal dystrophies, and diabetic retinopathy.

[0047] The treatment strips 10, 12 can be used throughout the day to take advantage of the patient's physiological blinking, but the treatment strips 10, 12 can also be used while the patient is resting or sleeping, or while the patient simply keeps the eyes closed. The treatment strips 10, 12 may be applied as single-use treatments, or may be configured to be robust enough to be reusable devices. In reusable embodiments, the adhesive components may be easily replaced while the thermal mechanism, circuitry, and sensors of the treatment strip are reused.

[0048] The treatment strips 10, 12 are desirably sufficiently flexible to accommodate movement of the upper eyelid UL and / or lower eyelid LL, which may move by approximately 15 mm or more. As such, the treatment strips 10, 12 can be made from a variety of materials.

[0049] 3 illustrates another variation in which the eyelid treatment system 30 may be formed into a bonded dual strip design, e.g., a "wishbone" design, where the dual strip heating strip may have two heating elements that conform to the location of the meibomian glands of the upper eyelid UL and lower eyelid LL of a single eye. Depending on whether both eyes or one eye, and / or both upper and lower eyelids are to be treated, the system 30 may include a first heating strip assembly 32 and a second heating strip assembly 34 for each corresponding eye. Each of the assemblies 32, 34 may accordingly utilize upper and lower eyelid treatment heaters, e.g., upper eyelid treatment strip 32A and lower eyelid treatment strip 32B, and each of the upper and lower elements may be coupled to one another via wires 36 (e.g., flexible circuits). Additionally, each of the assemblies 32, 34 may be coupled via a connecting cable 38 to a control unit 40 which may be coupled (e.g., via an input / output port such as a headphone jack, USB port, micro HDMI, or other connection port) to a portable electronic device 42 as shown (e.g., a smartphone, tablet, PDA, laptop computer, etc. having a touch screen interface).

[0050] In other variations, the number of connecting cables may range anywhere from one to four connector cables rather than utilizing a single cable 38. For example, a single cable may be used to provide power and communications to a few or all four heating elements in each of the assemblies 32, 34. Alternatively, four connecting cables may provide power and communications to each heating element in the assemblies 32, 34. In yet another alternative, two connecting cables may provide power and communications to each of the assemblies 32, 34.

[0051] In other additional variations, any of the described treatment strips may be used in operable combination with the control unit 42 described herein. In a further variation, an oval or circular heating element may cover the eye and both eyelids, with the outer edge of the heating element or strip following the path of the upper and lower meibomian glands. In this case, one treatment strip may cover both eyelids and both glands, and the user may use a total of two (rather than four) circular, round, or oval treatment strips to cover both eyes. Such variations may be used, for example, for overnight therapy in bed before or during sleep, where the eyes do not necessarily need to be open.

[0052] The assemblies 32, 34 may generally comprise strips that follow the location of the meibomian glands, as previously described, while still allowing the patient to blink easily and comfortably perform daily activities. An example of such a heater that may be configured for use in conjunction with the treatment system 30 may include a thin, flexible heater that is commercially available through companies such as Minco Products, Inc. (Minneapolis, MN) or may be custom designed and manufactured independently or through a third-party manufacturer. Each individual treatment strip, e.g., treatment strips 32A, 32B, may be sized for a single eyelid, e.g., 28 mm x 7 mm x 0.15 mm, have a basal chord length of, e.g., 28 mm, have a radius of curvature of, e.g., 75 mm, and have a general configuration of an arcuate rectangle with an obtuse angle at the nasal or temporal end that may coincide with the radius of the arc. However, these size limitations are intended to be illustrative and not limiting, as the treatment strips 32A, 32B may be sized to be smaller or larger to accommodate eyes with different anatomies.

[0053] Additionally, the individual treatment strips 32A, 32B may be formed as a thin, flexible, transparent polymer containing the heating element while the contact surface of the strip is affixed to the respective eyelid with, for example, a disposable adhesive. In other variations, opaque or colored strips, such as flesh-colored, may be utilized. Additionally, one or more temperature sensors may also be incorporated into the treatment strips, where the heating element and sensor may be wired to a power source and / or controller 40 and / or portable electronic device 42 via a connecting cable 38 as shown.

[0054] The control unit 40 may generally comprise a hardware / software platform or unit programmed to control a therapy treatment. Thus, the control unit 40 may include a processor as well as a power source, such as a battery (rechargeable or disposable) for powering the assemblies 32, 34. The power source within the control unit 40 may optionally be rechargeable separately from the portable electronic device 42, or the power source may also derive power for the assemblies 32, 34 and processor directly from the portable electronic device 42.

[0055] In the case where the control unit 40 is programmed to provide a therapy treatment protocol, one or more controls for controlling the treatment may be incorporated directly into the control unit 40. The portable electronic device 42 may interface with the control unit 40 and in one variation, some of the controls may be displayed on a screen (e.g., a touch screen) of the electronic device 42, such as controls for starting and / or stopping the treatment. The control unit may also facilitate detecting when leads are not properly connected, measuring power levels, measuring temperature levels, and so forth. Thus, if any of these values ​​are out of range, there is the ability to notify or warn the user, or to prevent the initiation of treatment or to stop treatment until these scenarios are explicitly recognized or corrected. Alternatively, all of the controls may be present on the control unit 40, while the display on the electronic device 42 serves primarily to display or track various results, treatment parameters, and / or treatment status. Separate combinations of the display and control unit may also be used.

[0056] In yet another alternative, all of the controls may reside not on the controller 40 but on the display of the electronic device 42 for controlling the various treatment options and parameters. In this variation, the electronic device 42 (a smartphone in this example) may provide power to the treatment strip assemblies 32, 34, control the various treatment temperatures and times, and may also receive and display temperature feedback or other physiological parameters that may be measured. In this case, the treatment strips 32, 34 and the connecting cable 38 may be plugged directly into the mobile or portable consumer electronic device 42. For example, the electronic device 42 may be used to display treatment parameters and controls such as icons or buttons to initiate treatment. In one example, the electronic device 42 may allow a user to initiate treatment to heat one or more of the strips of one or both of the treatment strip assemblies 32, 34. In either variation, the electronic device 42, particularly in the case of a smartphone or tablet, may have any programs or applications downloaded onto the device that facilitate the various control and / or display parameters on the electronic device 42 depending on how the electronic device 42 is used in combination with the controller 40 and the assemblies 32, 34. In some variants, the display and control display may reside on the control unit 40 itself or on another device separate from the control unit 40 .

[0057] Additionally, the electronic device 42 may provide diagnostic capabilities so that the user can test for dry eye and / or determine how treatment is progressing, either before, during, or after treatment. Thus, the electronic device 42 or control unit 40 may utilize, for example, a built-in camera and / or a flash / light source for purposes of imaging the user's ocular tear film or ocular surface and evaluating commonly used tear metrics, such as total tear film 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. Such a camera may display or "mirror" the placement of the strip for evaluation or adjustment, synchronously or asynchronously, by the user or remotely. In addition to imaging of the user's tear film and / or ocular surface condition, the mobile application can include other common methods for diagnosing dry eye, such as a user questionnaire regarding the user-patient's symptoms, discomfort, and / or improvement or worsening of symptoms, which can be completed using the electronic device's touchscreen interface, the results of which are stored on the electronic device 42 or a web application or manufacturer's server, tracked over time for trend assessment, and potentially shared with the user's physician.

[0058] Further, in any of the variations, the controller 40 and / or electronic device 42 may be programmed or initiated to heat the assemblies 32, 34 to, for example, 42.5° C.±1° C.-2° C. The treatment time may be set, for example, from 1 minute to 30 minutes or more, for example, 60 minutes. The controller 40 and / or electronic device 42 may be further programmed to shut down if the allotted treatment time has elapsed or if the measured temperature rises above a predetermined level, for example, 45° C. Additionally, the controller 40 and / or electronic device 42 may be further programmed or configured to indicate various treatment parameters (e.g., start of treatment, heating element warming, completion of treatment, error, battery life, etc.) by any number of visual, audible, or tactile indicators.

[0059] Additionally, the control unit 40 and / or electronic device 42 may be used to store and / or transmit various data, such as past treatment data, usage time, total treatment time, temperature data, etc. Additionally, the control unit 40 and / or electronic device 42 may wirelessly communicate with a remote server or additional control units, such that the control unit 40 and / or electronic device 42 may be remotely programmed, for example, by a physician or a third party. In yet other variations, audio and / or visual information (e.g., advertising, educational media, social media connectivity, or other media) may also be received from a remote server and displayed on the control unit 40 and / or electronic device 42, or various other data may be transmitted to and / or from the control unit 40 and / or electronic device 42 as well.

[0060] In yet other variations, the controller 40 is shown coupled to the assemblies 32, 34 via a wired connection cable 38, although in other variations the controller 40 may be wirelessly connected to the assemblies 32, 34. Such connection may be made via any number of wireless protocols, such as Bluetooth® or RF.

[0061] This "precise temperature controlled" mobile warming therapy system can also be used to heat other parts of the body; the system is similar, but the heating elements can be sized and power requirements can be altered depending on the total surface area to be treated, temperature goals, patient comfort, and other factors.

[0062] By incorporating a processor into the treatment strip, other parameters such as treatment time or temperature of the strip can be programmed and optionally selectively turned on or off by the patient or automatically, and other parameters such as frequency of heat delivery or other stimulation can also be programmed by the processor to provide additional flexibility in treatment.

[0063] In yet another variation, the treatment strip assembly may be used in combination with a controller 50 that is specifically designed and programmed for use in combination with the treatment strip assembly. One example of such a controller 50 is shown in the perspective view of FIG. 4, which shows the controller 50 comprising a housing 52, e.g., a circular shaped housing that may weigh less than (or more than) 8 ounces, which encloses a power source and a controller board having a programmable processor contained therein. The controller housing 52 may incorporate two ports 54 for plugging in two heater assemblies, a first port for connecting a first treatment assembly for a first eye and a second port for connecting a second treatment assembly for a second eye, although in other variations, a single port may be used to treat a single eye. A single port may be used when treating tissue surrounding only the first eye. A connector indicator 58 may be included to provide a visual indicator (and / or an audible indicator) to indicate to the user whether the first and / or second ports 54 have properly connected the heaters. A charging port 56 may also be incorporated into the housing 52 for connecting to a power source for charging the control unit 50. The port 54 for the heater assembly of the control unit may be oriented relative to the charging port 56 such that charging is not possible with any number of heaters connected to the control unit.

[0064] A power button 60 may be provided to allow a user to power the control 50 on and off, and a power indicator 62 may be provided to indicate the power level of the control 50. In addition to the power indicator 62, a temperature control 64 may also be provided to allow a user to adjust the temperature of the strip assembly during treatment, for example by pressing "+" or "-" as appropriate. Additionally, a timer 66 may be provided to provide feedback such as a visual (and / or audible) countdown of treatment time. For example, if a 15 minute timer is started, each indicator bar of the timer 66 will pulse for 1 minute and then turn off until the 15 minute treatment time has elapsed.

[0065] As shown in the perspective views of Figures 5A and 5B, the control unit 50 may provide a visual indication, as indicated by the connector indicator 58, when a first connector 70A for a first treatment strip assembly is inserted into the first port 54A, and similarly, when a second connector 70B for a second treatment strip assembly is inserted into the second port 54B.

[0066] With regard to the treatment strip assembly, another variation is shown in the perspective view of FIG. 6, which shows heating strips 80A, 80B (which may be applied to the upper eyelid UL and lower eyelid LL) coupled to a common joint 84 joining the heating strips 80A, 80B via corresponding connectors 82A, 82B (e.g., flexible connectors to accommodate positioning of the heating strips 80A, 80B relative to the patient). The joint 84 may be connected to a coupler 90 having a receiving port 92 sized to removably receive the joint 84. The coupler 90 may be connected to a cable 94 (which may be several feet long, e.g., to reach from the patient's eye to the control unit 350 when placed on the wrist), which is then coupled to port 54A or 54B.

[0067] Since the treatment strip assembly may be designed for single use, the treatment strip may be marked or otherwise electronically tagged (such as via the interface 84 or other indicator) to prevent reuse by the controller board when a previously used treatment strip is connected to the control unit 350. In one variation, the interface 84 may incorporate a usage tracking mechanism 88, such as a memory chip that may be programmed to have a memory of a "0" or "1" that may indicate to the controller board that a particular treatment strip assembly has been previously used, as shown in the detailed perspective view of FIG. 7A. In another variation, the usage tracking mechanism 88 may comprise a sacrificial fuse disposed on the interface 84. A short burst of high energy may also be provided by the control unit to the mechanism 88 to blow the fuse. The control unit may then reduce the energy for the treatment and deliver the appropriate temperature treatment. Optionally, once the treatment strip assembly has been used, the interface 84 may be removed from the receiving port 92 and another interface may be inserted for a new treatment strip assembly for another treatment or for another patient.

[0068] In other variations, the treatment strip may incorporate an antenna and a transmitter and / or receiver for communicating wirelessly with the controller board rather than via a wired connection.

[0069] Each of the heating strips 80A, 80B may include one or more corresponding sensors 86A, 86B, such as thermistors or thermocouples, which are coupled to a common wire connector or separate wires, as also shown in FIG. 7A, and disposed on the strip to provide treatment feedback to the controller board 382 of each eyelid strip. Each of the heating strips 80A, 80B may incorporate anywhere from one to four temperature sensors on each strip, such as, for example, one sensor disposed at a first end of the strip, a second sensor disposed at a middle portion, and a third sensor disposed at a second end. FIG. 7B is a top view of the heating strips 80A, 80B, illustrating how each strip may incorporate one or more sensors. As shown, the first strip 80A may have a first sensor 100A disposed near or at a first end, such as the distal end, of the strip, a second sensor 100A' disposed in the middle of the strip, and a third sensor 100A" disposed near or at a second end, such as the proximal end, of the strip. Similarly, in the second strip 80B, the first sensor 100B may be disposed near or at a first end, such as the distal end, a second sensor 100B' disposed in the middle of the strip, and a third sensor 100B" disposed near or at a second end, such as the proximal end, of the strip.

[0070] Additional temperature sensors may also be placed on or near the patient's body, for example, near the patient's temple, on additional treatment strips, or away from the treatment strip placed on the patient's eyelid, to measure and monitor the outside temperature where the patient is receiving treatment. This additional outside temperature data helps ensure that the treatment strip itself is operating properly and providing the targeted temperature therapy. The sensors may be used in a comparison mode to determine if any portion of the treatment strip is not in contact with the patient or has failed.

[0071] As mentioned above, to aid in the treatment of MGD, the meibomian glands may be mechanically pressed or squeezed to express coagulated meibum from the glands. Forceps are commonly used to apply pressure to the meibomian glands. In addition to treating MGD, forceps can also be used to treat bruises, joint pain, muscle pain, styes, styes, chalazions, abscesses, and other skin conditions. Forceps can also be used in dental applications, such as curing adhesives, fillers, and the like. Forceps can also be used for medical purposes, such as tissue resection and hemostasis, as well as non-medical purposes, such as welding systems.

[0072] One variation of a forceps is shown in the perspective view of Fig. 8, which shows a forceps 110. The forceps 110 has a first handle 110A and a second handle 110B joined at a proximal end, and a first bridge 114A and a second bridge 114B are optionally positioned to extend parallel to and optionally curved with respect to the handles 110A, 110B such that a first jaw or paddle 112A is arranged to face a second jaw or paddle 112B. The first paddle 112A and the second paddle 112B may also be arranged such that corresponding first inner surfaces 116A and second inner surfaces 116B are angled relative to one another to impart a directional pressure gradient to the contacted tissue, e.g., a pressure gradient in a direction perpendicular to the direction of force application, to facilitate expression of the meibomian glands, as described in more detail below. The angled surfaces of the paddles may also interlock with one another to provide a gradual pinching motion or gradual opposing of the paddle surfaces from one end of the paddle to the other. The first and second paddles 112A, 112B may be sized for positioning directly on the patient's eyelid in close proximity to the eye, or the paddles 112A, 112B may be spaced apart from one another to allow for positioning of tissue therebetween (e.g., eyelid tissue including the meibomian glands). In other variations, the first and second handles 110A, 110B may be curved or arcuate, provided that the paddles 112A, 112B are spaced apart from one another.

[0073] The forceps 110 may be configured to be disposable for a single use, or may be configured to be fully reusable. Alternatively, the forceps 110 may be configured to be partially disposable, e.g., the forceps 110 has reusable handles 110A, 110B with first and second paddles 112A, 112B, or other portions that are removably disposable. Thus, the forceps 110 may be made in part or in whole from any number of different materials, e.g., polymers, metals, composites, ceramics, and the like. One or both of the paddles may be of a suitable size for application to various parts of the body, but when configured to treat the meibomian glands, the paddles may have a height H anywhere from 1 mm to 20 mm, e.g., anywhere from 1 mm to 50 mm, and a length L anywhere from 1 mm to 50 mm, e.g., anywhere from 5 mm to 25 mm, respectively. In one variation, one or both paddles may have a height H and a length L, e.g., 5 mm by 25 mm, respectively.

[0074] Additionally, one or both paddles 112A, 112B may optionally incorporate an insulating or reflective layer 120 that may be used to protect contacted tissue and increase the efficiency and effectiveness of therapeutic therapy. The insulating or reflective layer 120 may be integrated into one or both interior surfaces, and the insulating or reflective layer 120 may be configured to cover a partial or entire surface of the paddle, as needed or desired.

[0075] When treating the meibomian glands, one or both paddles 112A, 112B may be configured to heat to a predetermined temperature range, optionally for a predetermined period of time. In one variation, the forceps 110 may have heating strips or sleeves attached or secured onto each paddle or otherwise applied as separate elements.

[0076] Any of the forceps or forceps combinations described herein may be packaged and distributed individually, however, as shown in FIG. 9, the forceps or forceps combinations may be packaged in a kit 130 to include not only the forceps 110 but also various combinations of additional devices or treatments. In one example, a pharmaceutical treatment 132 (e.g., eye drops, ointments, medications, etc.) may be included, as well as an optional heating strip 134 that may be applied to the skin surface of the patient's eyelid (or in close proximity to the eyelid) to heat and / or preheat the meibomian glands prior to or during expression of the glands by the forceps 110. Such a kit 130 may provide a complete treatment solution. Additionally, although the pharmaceutical treatment 132 and optional heating strip 134 are shown included in the kit 130 with the forceps 110, any combination of these may be included in the kit 130, as well as various other treatments or devices.

[0077] Another example of a kit 140 is shown in FIG 10A which illustrates one or more heating strips 124 provided in combination with forceps 142. In this variation, the forceps 142 may be configured with paddles 124 defining grooves 126 extending across one or more inner surfaces between the lower and upper ends of one or both paddles 122 to facilitate mechanical expression after (or prior to) heat treatment. Optionally, the heating strips 124 may be single use and disposable, if desired.

[0078] 10B illustrates yet another example of a kit that includes one or more heating strips 134 and forceps 142 as described above, but optionally also includes a controller 50 for controlling thermal treatment of the one or more heating strips 134. The controller 50 may be a reusable unit, while the heating strips 134 and / or forceps 142 may optionally be configured as single use and disposable, if desired.

[0079] 10C illustrates yet another example of a kit 144 that also includes forceps 150 configured to facilitate mechanical expression as well as tissue debridement, and can optionally include a controller 50, a pharmaceutical treatment 132, and / or one or more heating strips 134 in various combinations. For example, the kit 144 includes a combination of forceps 150 and one or more heating strips 134, while in other variations, the kit 144 can include a combination of forceps 150, one or more heating strips 134, and a controller 50. In yet other variations, the kit 144 can incorporate one or more eyelid wipes 136 for cleaning or wiping the surface of the eyelid to remove oils, makeup, and the like, so that the heat treatment strip 134 can be stably adhered to the eyelid. The eyelid wipes 136 can be included with the forceps 150, one or more heating strips 134, and / or the controller 50.

[0080] Another variation of the forceps 150 is shown in further detail in FIGS. 11A-11D, which show side, top, end, and perspective views, respectively. This variation of the forceps 150 has two juxtaposed handles 152A, 152B extending from a common pivot joint 154. The two juxtaposed handles 152A, 152B may terminate at their distal ends in corresponding paddles 156A, 156B, respectively, and the proximal end of the forceps 150 may include a proximally extending debridement member 158 that forms a curved or arcuate debridement end 160 around the periphery of the member 158. The gap G defined between the paddles 156A, 156B may be varied to accommodate various anatomical tissue structures, so that the open gap G at rest may range, for example, from 5.72 mm to 9.09 mm.

[0081] FIG. 12A shows a detailed side view of paddle 156B, which may have a length L, for example, between 7.37 mm and 8.26 mm, and a width, for example, on the order of 4.00 mm. Paddles 156A, 156B may be configured to have a square or rectangular shape, as shown, although in other variations, paddles may be configured in a variety of other shapes, such as, for example, oval. To facilitate positioning of paddles 156A, 156B relative to the tissue region of the eye to be mechanically expressed, paddles 156A, 156B may be angled along their length L to define an angle 172 relative to longitudinal axis 170 of forceps 150. In one variation, angle 172 may define an angle of, for example, 35°, although angle 172 may range, for example, from 0° to 90°, depending on the desired application for use.

[0082] The debridement end 160 may be defined around the periphery of the debridement member 158, although other variations of the forceps may have a debridement end defined along the edge of the paddle. One example is shown in the side view of FIG. 12B, which shows a paddle 156B having one or more debridement ends. For example, the distal end 162A of the paddle 156B may be configured as a debridement end, although other variations may have either the distal end 162B or the proximal end 162C of one or both paddles as a debridement end. Also, other variations may include one or more debridement ends on one or both paddles, as desired.

[0083] The debleeding member 158 extending from the proximal end of the forceps 150 may define a relatively thin end 160 relative to the remainder of the forceps 150. In one variation, the debleeding member 158 may have a length along the proximal direction, for example between 10.00 mm and 11.00 mm or 10.67 mm, and a width, for example between 8.00 mm and 9.00 mm, for example 8.13 mm, which narrows and curves gently, for example, into an elliptical or semi-elliptical shape, as shown in the detailed view of FIG. 13A. In other variations, the shape of the periphery of the debleeding member 158 may approximate other shapes, such as a semicircle, a parabola, a rectangle, a triangle, etc., provided the debleeding end 160 is presented for use. FIG. 13B is a detailed end view of the debleeding member 158, further illustrating the debleeding end 160 having a thickness TH. Edge 160, shown in detail in Figure 13B, may further define a radial edge, for example ranging from 0.05 mm to 0.13 mm. Thickness TH may range, for example, from 0.40 mm to 0.55 mm, such as 0.46 mm ± 0.05 mm, although this thickness TH may vary, for example, up to 0.92 mm, provided that edge 160 is materially thinner from handles 152A, 152B of forceps 150 to provide an effective scraping edge.

[0084] The debleeding member 158 may define a plane that is coplanar or parallel to the plane defined by the paddles 156A, 156B when the paddles 156A, 156B are compressed toward one another. In other variations, the plane of the debleeding member 158 may be lateral or form other angles with respect to the plane defined by the paddles 156A, 156B.

[0085] In use, the paddles 156A, 156B may be used to directly mechanically express the meibomian glands and / or to apply pressure to tissue areas proximate the meibomian glands, while the debridement end 160 may be used to scrape along the upper lid UL edge and / or lower lid LL edge before, during, and / or after mechanical expression to remove obstructions from the meibomian glands, for example, along the direction of debridement 180 shown in Figure 14. Additionally, mechanical expression and / or debridement with the forceps 150 may occur at any time and in any processing sequence during heat treatment with one or more heating strips 134. For example, the upper eyelid UL and / or lower eyelid LL may be thermally treated for a predetermined period of time using one or more heating strips 134, after which the upper eyelid and / or lower eyelid may be mechanically expressed using forceps 150 and then subjected to debridement using the debridement end 160, whether after, during, and / or before the thermal treatment.

[0086] Alternatively, the tissue may be debridement using the debridement tip 160 before, during, and / or after thermal treatment with or without mechanical expression, or the tissue may be subjected to only mechanical expression without the debridement tip 160. In other variations, the tissue may be first debridement with the debridement tip and then thermal treatment with the treatment strip. The debridement procedure may be performed with the treatment strip on the patient or before the treatment strip is applied. The meibomian glands may then be mechanically expressed using forceps. The mechanical expression may be performed with the treatment strip on the patient or after the strip is removed. Different combinations of procedures may be used depending on the desired results.

[0087] An alternative variation of the debridement embodiment is detailed in the side views of Figures 15A-15C, which show the debridement element defining a notch or groove into which a cross section of the eyelid is received so that debridement, such as a side-to-side sweeping motion, occurs with the eyelid edge maintained within the notch. Such a feature can enhance the safety of the instrument, as it can prevent the debridement element from inadvertently entering the eye as the instrument is moved from side to side.

[0088] One variation is shown in FIGURE 15A, which shows the debridement member 158 previously described, but with a notch or groove 192 defined along the side of the member 158 proximate the proximal end of the debridement member 158. Alternatively, the debridement end 160 may be replaced with a smooth, atraumatic proximal end 190, and a concave end 194 of the notch or groove 192 may define the debridement end. The side edges 196 within the notch or groove 192 on either side of the concave end 194 may be smooth and atraumatic to avoid trauma to the anterior and posterior eyelids during sweeping and side-to-side debridement.

[0089] Because the extreme ends of the debridement members 158 may contact the surface of the eye during use, the members 158 may be rounded or smoothed to present a blunt, non-invasive surface to avoid abrasion or other damage to the surface of the eye. FIG. 15B shows another variation in which the proximal end 198 is even more blunt, and FIG. 15C shows yet another variation in which the proximal end 200 is rounded and presents a gently curved edge or surface. In any of these variations, a layer or separate end made of a different material than the forceps may be disposed over, on, or otherwise attached to the proximal end, which may be a relatively soft material, such as silicone, rubber, foam, etc., to provide an additional feature to prevent injury to the surface of the eye.

[0090] The applications of the above-mentioned devices and methods are not limited to the treatment of dry eye syndrome, but may include any number of additional therapeutic applications. Moreover, such devices and methods may be applied to other treatment sites within the body where acute or chronic inflammation causes disease or symptoms. Accordingly, the treatment strips may be custom designed along the pathways of the underlying physiology, for example, cooling or heating treatment strips may be custom designed and contoured to treat sinuses and acute or chronic sinusitis, rhinitis and allergic rhinitis, joint pain and inflammation, arthritis, muscle pain, back pain, headaches, wounds, sports injuries, and the like. Variations of the above-mentioned assemblies and methods for carrying out the invention, combinations between different variations that may be carried out, 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 first handle and a second handle coupled to one another via a common pivot connection near or at their respective proximal ends; a first paddle coupled to the first handle and defining a first inner surface, the first inner surface extending from a first edge connected to the first handle; a second paddle coupled to the second handle and defining a second inner surface, the second inner surface extending from a second edge connected to the second handle and positioned such that the second inner surface opposes the first inner surface, defining a plane when the first paddle and the second paddle are compressed together; a debridement member extending proximally from the common pivot joint, the debridement member having a planar thickness that decreases relative to the common pivot joint and defining a rounded debridement edge along a periphery of the planar thickness for debriding tissue adjacent one or more meibomian glands, the planar thickness of the debridement member having a reduced thickness compared to each of the first handle and the second handle for debriding the tissue; A forceps device comprising:

2. 10. The apparatus of claim 1, wherein the debridement member has a length between 10.00 mm and 11.00 mm.

3. 10. The apparatus of claim 1, wherein the debridement member has a width between 8.00 mm and 9.00 mm.

4. 10. The apparatus of claim 1, wherein the debridement member has a thickness between 0.40 mm and 0.55 mm.

5. 10. The device of claim 1, wherein the rounded debridement edge along the periphery of the planar thickness has a radius of between 0.05 mm and 0.13 mm.

6. 2. The device of claim 1, wherein the width of the debridement member tapers in an elliptical shape along a proximal direction of the debridement member.

7. 2. The apparatus of claim 1, wherein said first and second paddles have an open gap therebetween when not compressed together.

8. 2. The apparatus of claim 1, wherein said peripheral edge of said planar thickness is shaped to transition smoothly to said pivot connection.

9. 2. The device of claim 1, wherein the first and second paddles define an angle of 35 degrees relative to a longitudinal axis of the forceps.

10. 13. A kit comprising the forceps device of claim 1 and one or more strips configured to adhere to an underlying area of ​​skin adjacent one or both eyes of a subject, wherein the one or more strips allow the subject to blink naturally with minimal or no restriction from the one or more strips.

11. 11. The kit of claim 10, wherein the one or more strips are configured to emit thermal energy to the underlying region of the skin, and the one or more strips are configured to conform to the location of one or more meibomian glands contained within the underlying region of the skin.

12. 11. The kit of claim 10, further comprising a controller in communication with the one or more strips, the controller being programmable to monitor and guide temperature within the one or more strips to provide therapy.

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