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(12) Patent Application Publication (10) Pub. No.: US 2013/0172829 A1 BADAW (43) Pub US 2013 0172829A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2013/0172829 A1 BADAW (43) Pub. Date: Jul. 4, 2013 (54) DRY EYE TREATMENT SYSTEMS (52) U.S. Cl. CPC .................................... A61F 9/0008 (2013.01) (71) Applicant: SIGHT SCIENCES, INC., San USPC .......................................................... 604/294 Francisco, CA (US) (72) Inventor: Paul BADAWI, San Francisco, CA (US) (57) ABSTRACT (73) Assignee: SIGHT SCIENCES, INC., San Dry eye treatment apparatus and methods are described Francisco, CA (US) herein which generally comprise a patch or strip affixed to the skin of the upper and/or lower eyelids to deliver heat or other (21) Appl. No.: 13/645,985 forms of energy, pressure, drugs, moisture, etc. (alone or in combination) to the one or more meibomianglands contained (22) Filed: Oct. 5, 2012 within the underlying skin. The treatment strip or strips include one or more strips configured to adhere to an under Related U.S. Application Data lying region of skin in proximity to one or both eyes of a (63) Continuation-in-part of application No. 13/343,407, subject such that the one or more strips allow for the subject filed on Jan. 4, 2012. to blink naturally without restriction from the one or more patches. Moreover, the one or more Strips may be configured Publication Classification to emit energy to the underlying region of skin and where the one or more strips are shaped to follow a location of one or 51) Int.nt. CC. more me1bOm1amibomiam gland S COnta1nedined W1thinwithin the underlyingunderW1n A6DF 9/00 (2006.01) region of skin. Patent Application Publication Jul. 4, 2013 Sheet 1 of 21 US 2013/0172829 A1 ... 3 * Patent Application Publication Jul. 4, 2013 Sheet 2 of 21 US 2013/0172829 A1 . A Patent Application Publication Jul. 4, 2013 Sheet 3 of 21 US 2013/0172829 A1 is is is 33 Patent Application Publication Jul. 4, 2013 Sheet 4 of 21 US 2013/0172829 A1 Fig. 3 Fics. 3D Patent Application Publication Jul. 4, 2013 Sheet 5 of 21 US 2013/0172829 A1 Patent Application Publication Jul. 4, 2013 Sheet 6 of 21 US 2013/0172829 A1 is, 8 & . Patent Application Publication Jul. 4, 2013 Sheet 7 of 21 US 2013/0172829 A1 Patent Application Publication Jul. 4, 2013 Sheet 8 of 21 US 2013/0172829 A1 & Patent Application Publication Jul. 4, 2013 Sheet 9 of 21 US 2013/0172829 A1 ... 3 Patent Application Publication Jul. 4, 2013 Sheet 10 of 21 US 2013/0172829 A1 Patent Application Publication Jul. 4, 2013 Sheet 11 of 21 US 2013/0172829 A1 is, 8 : ... 3 Patent Application Publication Jul. 4, 2013 Sheet 12 of 21 US 2013/0172829 A1 . Patent Application Publication Jul. 4, 2013 Sheet 13 of 21 US 2013/0172829 A1 s Patent Application Publication Jul. 4, 2013 Sheet 14 of 21 US 2013/0172829 A1 Patent Application Publication Jul. 4, 2013 Sheet 15 of 21 US 2013/0172829 A1 , is rix, is . Patent Application Publication Jul. 4, 2013 Sheet 16 of 21 US 2013/0172829 A1 *c. 28 Patent Application Publication Jul. 4, 2013 Sheet 17 of 21 US 2013/0172829 A1 ... 3 Patent Application Publication Jul. 4, 2013 Sheet 18 of 21 US 2013/0172829 A1 Patent Application Publication Jul. 4, 2013 Sheet 19 of 21 US 2013/0172829 A1 ... 3 Patent Application Publication Jul. 4, 2013 Sheet 20 of 21 US 2013/0172829 A1 &x. $33. Patent Application Publication Jul. 4, 2013 Sheet 21 of 21 US 2013/0172829 A1 33 FS. 39 US 2013/0172829 A1 Jul. 4, 2013 DRY EYE TREATMENT SYSTEMS length of the upper eyelid UL (and lower eyelid LL) with the duct opening along the inner edge of the eyelid UL in proX CROSS-REFERENCE TO RELATED imity to a Surface of the underlying eye. APPLICATIONS 0007 FIG. 1B illustrates a front view of a patient’s eye 0001. This is a continuation-in-part of U.S. patent appli having the upper eyelid UL and lower eyelid LL in a closed cation Ser. No. 13/343,407 filed Jan. 4, 2012, which is incor position, such as when the patient blinks. As shown, the porated herein by reference in its entirety. meibomian glands MG may be seen aligned adjacent to one another over both the upper UL and lower eyelids LL. FIG. FIELD OF THE INVENTION 1C also shows a perspective view of a patient's eye in the open position to illustrate how the meibomianglands are typically 0002 The present invention relates to methods and appa aligned relative to one another when the patient’s eye is ratus for treatment of dry eye syndrome and other related opened. conditions. More particularly, the present invention relates to 0008 Blinking is thought to be the primary mechanism to methods and apparatus for the treatment of dry eye syndrome open the orifice of the meibomian glands to allow for the using adhesive strips which are specifically contoured or release of oil secretions from the glands. The natural blinking shaped to adhere to selected regions around apatient’s eyes or motion and blinking force causes the upper lid to pull a sheet peri-orbital region. of the lipids secreted by the meibomian glands over the two underlying layers of the tear film thus forming the protective BACKGROUND OF THE INVENTION coating which limits the rate at which the underlying layers 0003) Tears area complex mixture of water, lipids, mucus, evaporate. it is estimated that approximately 65% of meibo proteins and electrolytes and this mixture helps to maintain a mian gland disease or dry eye results from a defective lipid Smooth and clear optical Surface and also helps to protect the layer or an insufficient quantity of Such lipids that results in eyes from infection. The tear film has three basic layers: oil, accelerated evaporation of the aqueous layer. Hence, blinking water, and mucus and problems or disturbances in any of disorders, or other disorders that affect proper tear distribu these layers can cause dry eyes symptoms. tion, may also cause or exacerbate meibomiangland dysfunc 0004. The outermost layer of the tear film is typically tion or dry eye. comprised of an oil layer containing fatty acids and lipids 0009. As the eyelids close in a total blink, the superior and (meibum) which are produced primarily by Sebaceous glands inferior fornices, which hold a reservoir of tears, are com called the meibomian glands located along the eyelid margin. pressed by the force of the preseptal muscles and the eyelids The oil layer smoothes the tear surface and slows evaporation move toward one another. The upper eyelid, for instance, of the watery middle layer. However, if the meibomianglands moves over the eye while exerting upon the eye surface a fail to produce enough oil, produce Suboptimal fatty acid force which helps to clear the front of the eye of debris, mixtures, or if the glands become obstructed or clogged, the insoluble mucin, and also expresses the oil secretions from watery layer typically evaporates too quickly causing dry the meibomian glands. The lower lid moves horizontally in eyes. A blockage of the meibomian glands can lead to the nasal direction and pushes debris toward both punctae, the enlarged glands or infections. Dry eyes are thus common in openings that ultimately drain into the nasal cavities. people whose meibomian glands are obstructed or function 0010. As the eyelids open the tear film is redistributed ing improperly. where the upper lid pulls the aqueous phase via capillary 0005. The middle layer of tears is composed primarily of action and the lipid layer spreads as quickly as the eyelids an aqueous solution, which is produced by the lacrimal glands move. Hence, eyelid movement is accordingly important in (tear glands). The middle layer cleanses the eyes and washes tear-film renewal, distribution, turnover, and drainage. away foreign particles or irritants, maintains a clear optical 0011 For a variety of reasons, the meibomian glands can medium, and keeps the ocular Surface moist. The innermost become blocked, plugged, or occluded resulting in meibo layer of the tear film is composed primarily of mucus which mian gland dysfunction and dry eye disease. The obstruction helps to spread the tears evenly over the surface of the eyes. A that triggers the disease can occur anywhere within the mei lack of mucus in the tear film is also associated with dry eye bomian gland, for instance, at the gland's Surface, or orifice syndrome. preventing normal lipid secretions from flowing; in the main 0006. As discussed above, the meibomian glands are oil channel of the gland which may be narrowed or blocked; or in secreting glands located within both the upper and lower other locations deeper within the gland that lead to the main eyelids. There are approximately 30 to 40 glands along the channel. upper eyelid and approximately 20 to 30 glands along the 0012 Treatments for blocked meibomian glands may lower eyelid with the ducts for each of the glands opening include a number conventional treatments. One course of along the inner edge of the free margin of the respective lids treatment includes the application of Soap and cleaning by minute foramina through which their secretion is released agents, eyelid scrubs, or antibiotics to reduce eyelid inflam to prevent the lids adhering to each other. An example of the mation. Antibiotics such as tetracycline, doxycycline, met location of the meibomian glands is illustrated in the cross ronidazole, or erythromycin can be administered orally or sectional view of the upper eyelid UL shown in FIG. 1A topically to help regulate or improve meibomian gland lipid which illustrates the relative positioning of a single meibo production.
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