Eyewear including chamber for optical solution

Abstract

Eyewear including a sealing member shaped to circumscribe at least one eye; a chamber adapted hold an introduced optical fluid when the sealing member is pressed against a face of a user; and a port in fluid communication with the chamber to introduce an optical liquid.

Description

EYEWEAR INCLUDING CHAMBER FOR OPTICAL SOLUTIONFIELD OF THE INVENTION

[0001] Embodiments of the subject disclosure relate to eyewear including optical solution as an optical and / or therapeutic element in fluid communication (e.g., in sealed fluid engagement) with one or more eyes useful, for example, to treat dry eye or eye fatigue. In addition, the subject disclosure relates to eyewear incorporating an external lens useful, for example, to correct eye conditions, such as conditions attributable to an irregular shaped cornea (e.g., keratoconus) and / or to generally provide improved visual acuity. Further, embodiments of the subject disclosure relate to a drug delivery device and to an eyewash to remove foreign and / or deleterious objects from the eye.BACKGROUND OF THE INVENTION

[0002] The cornea is the dome shaped, transparent front layer of the eye. Among other functions, the shape of the cornea serves to refract light and, in conjunction with the lens, focus incoming light correctly on the retina. In humans, the cornea has a diameter of about 1 1 .5 mm and a thickness of 0.5-0.6 mm in the center and 0.6- 0.8 mm at the periphery. The front layer of the cornea consists of the epithelium, which is prone towards injury and nerve aggravation.

[0003] There are numerous eye conditions caused by corneal irregularities. Astigmatism is very common and can be caused by an irregular shaped cornea. Other corneal dystrophies are known and afflict the population with varying degrees of regularity, such as map-dot dystrophy, Lisch corneal dystrophy, Meesmann corneal dystrophy, Reis-bucklers corneal dystrophy and Thiel-behnke corneal dystrophy.

[0004] Another condition of the cornea is chronic dry eye disease. This is a multifactorial disease state that results in discomfort, eye pain, and epithelial defects. Chronic dry eye disease occurs when a subject’s ocular surface is not properly lubricated or there is trauma to the nerves of the epithelium. When the eye is in this state, it is very difficult for it to heal itself because it is not exposed to fluid which in turn promotes eye healing.

[0005] Keratoconus, as another example, is an eye condition in which a part of the cornea that is partly in front of the pupil slowly becomes thinner, resulting in cone- shaped deformation. The condition is not uncommon, estimated to occur in one out of 1 ,500 persons, though some estimate that as many as 1 in 400 individuals may be affected in some form. As a result of the corneal deformation, light is not properly directed to the retina, and sometimes cannot be adequately corrected, even when corrected with standard glasses or contact lenses.

[0006] The first line of treatment for correcting vision in subjects having keratoconus involves the use of scleral contact lens to correct the shape of the cornea. Scleral lenses are larger than normal contact lenses. Instead of being supported directly on the cornea like a standard contact lens, scleral lenses fit onto, and are supported by the sclera, the white portion of the eye. In comparison to standard corneal contact lenses, scleral lenses bulge outward considerably more, creating a space between the cornea and the lens, which can be filled with liquid (e.g., saline). The liquid, which is contained in a thin elastic reservoir, conforms the irregularities of the deformed cornea, allowing vision to be restored.

[0007] Hard or rigid gas permeable (RGP or GP) contact lenses can also find use to treat keratoconus and other deformities and irregularities of the cornea, in function, acting as a second surface (cornea) for the eye. Hybrid contact lenses which are provided with a soft peripheral skirting to ameliorate discomfort, can also be used in certain instances. Although improving visual acuity for some subjects, users of RGP and hybrid lenses tend to report more irritation and discomfort than users of standard, soft contact lenses.

[0008] While scleral and hard contact lenses achieve variable levels of success in correcting vision, they do not always sufficiently restore vision in all subjects. A large reason for this is contact lens intolerance and put more simply, pain. There are many people who experience pain and discomfort when any material is placed on the cornea of the eye. This is, after all, a particularly sensitive part of the human body with lots of nerve endings.

[0009] As such, there remains a need for alternative therapies for such individuals in order to achieve an acceptable level of visual acuity required to engage in daily activities (e.g., reading, driving a motor vehicle). Even if visual acuity can be sufficiently restored with scleral or hard contact lenses, subjects are nevertheless required to wear such lenses almost exclusively during their waking hours, which in turn can create dry eyes, particularly for hard contact users, and general eye fatigue. There remains a need for an alternative to scleral and hard contacts lenses for subjects having corneal irregularities. Such need is particularly present, for example, at the end of the day after the subject’s eyes have experienced the continuous stress from wearing their lenses over the course of the day.

[0010] Additionally, as mentioned above, there are other eye conditions for which alternative treatment therapies are desired affecting the general population. Dry eye, for example, is a condition that affects the general public at one time or another, particularly given the large amount of time viewing electronic computer screens and phones. Even subjects with healthy eyes suffer from eye fatigue after performing daily activities, such as computer work or extended driving. For example, studies have suggested that the blink rate of the eye is reduced by 60-70% while looking at a computer screen. This stress on the eye accumulates over time causing eye fatigue and discomfort. Accordingly, dry eye can become a chronic condition in many, requiring medical intervention particularly in sensitive subjects (e.g., subjects with underlying eye conditions, lifestyle that is harsh to the eyes, or subjects of a certain or advanced age (e.g., post-menopausal women). Also, finding ways to hydrate the eye while maintaining a calm trigeminal nerve are important unmet needs.

[0011] Specifically, stress on the eye attendant to daily living can cause damage to the epithelium. Numerous studies have shown that prolonged exposure to fluid offers therapeutic benefits to the eye. Some of these benefits include but are not limited to epithelial healing, formation of tight junctions, and better nutrient and oxygen transfer. The surface of the eye is a fast-healing tissue. Offering exposure to fluid allows the eye the ability to heal itself quickly. Scleral lens wear can actually help heal the epithelial surface since it exposes the eye to fluid. However this process is extremely expensiveand time-consuming and difficult for the patient to implement. An alternative and less expensive way to expose the eye to fluid is needed. (See, e.g., “Gas-permeable Scleral Contact Lens Therapy in Ocular Surface Disease, Romero-Rangel, MD, Rosenthal, Perry MD, Foster, Stephen MD).

[0012] There also remains a need, amongst the general population, to achieve improved visual acuity. For example, participants in activities where visual acuity is at a premium (e.g., surgeons, marksmen, police and armed forces service people, hunters, baseball or other sporting participants) can benefit from improving their vision beyond what can be accomplished with traditional eyewear or contact lenses.

[0013] There also remains a need for improved drug delivery to the eye. Eye drops can be problematic because the eye drops do not stay on the surface of the eye for a long period of time, due to blinking and draining of the drop into the lacrimal duct. As a result, eye drop manufacturers increase concentrations (which make the eye drop uncomfortable) or ask for repeated daily administration (which makes compliance by the user a problem).

[0014] Lastly, there further remains a need for improved emergency care for insults to the eye, such as chemical insults (e.g., ICD-9-CM: 940.2, 940.3, 372.06; ICD-10-CM: T26.60XA). As explained by Patel, Chemical (Alkali and Acid) Injury of the Conjuctiva and Cornea, EyeWiki, chemical injuries to the eye can represent up to 20% or more of ocular traumas, with a large number occurring in the workplace as a result of industrial accidents. Time is of the essence, and the damaging effects of the insult can be remediated if the eye is quickly irrigated.

[0015] Current means to irrigate the eye in such situations include eye stations, which are typically stationary and may not be near the site of injury. Other methods, such as the Morgan Medi-flow Lens (MorTan, Inc., Missoula, MT), generally require a trained medical professional to apply or, in any event, is not easily applied by a layman in an emergency. There thus remains a need for more convenient and portable means for immediately irrigating the eyes during such an emergency.SUMMARY

[0016] The eyewear of the subject disclosure addresses these needs. In certain embodiments, the instantly disclosed eyewear, which maintains restorative optical fluid next to the eye, provide a form a therapy that has several functions, including 1 ) healing the ocular surface of the eye; 2) providing pain relief; and 3) offering improved visual acuity, particularly subjects with irregular cornea astigmatism.

[0017] In one exemplary embodiment, the eyewear includes a sealing member shaped to circumscribe at least one eye, a chamber adapted to hold an introduced optical fluid when the sealing member is pressed against a face of a user, and a port in fluid communication with the chamber to introduce the optical fluid. The eyewear can further include, in certain embodiments, one or more lenses distally positioned with respect to the chamber, and / or a headband to secure the sealing member about the face of the user.

[0018] Another exemplary embodiment provides eyewear that includes a sealing member shaped to circumscribe at least one eye, a chamber adapted to hold an introduced optical fluid when the sealing member is pressed against a face of a user, a port in fluid communication with the chamber to introduce an optical liquid, and one or more lens containers extending distally from the chamber.

[0019] In certain embodiments directed to improving visual acuity, the lens container can include one or more corrective lenses. The eyewear can further include a frame extending from the sealing element and forming a boundary of the chamber.

[0020] The eyewear of the subject disclosure, in certain embodiments, is adjustable so as to position the lens containers in a desired location with respect to the user’s eye. In exemplary embodiments, the eyewear includes an adjustment mechanism operatively connected to the frame and adapted to adjust the one or more lens containers in at least one direction.

[0021] For example, in one exemplary embodiment, the lens container includes a thread and the adjustment mechanism includes a complimentary thread engaged with the lens container to move the lens container in a direction to and away from the eye of the user. In one exemplary embodiment, the adjustment mechanism includes a plate in sliding engagement with the frame of the eyewear. In a still further exemplary embodiment, the adjustment mechanism includes one or more pivot shafts engaging the frame and allowing the adjustment mechanism to pivot with respect to the frame.

[0022] The subject disclosure also provides a kit that includes the eyewear of any one of the embodiments disclosed herein and a supply of optical fluid. In certain embodiments, the optical fluid is a solution that is isotonic to the cornea and suitable for ocular administration (e.g., an isotonic saline solution). In certain embodiments, the optical fluid is maintained at a comfortable temperature, such as at a temperature of about 90SF to about 110SF. In certain embodiments, the fluid contains therapeutically or biologically active agents for tissue (e.g., optical tissue) healing or maintenance (e.g., hyaluronic acid and / or carboxymethyl cellulose) that can offer therapeutic benefits in addition to, for example, the isotonic saline solution. Such therapeutic benefits include, but are not limited to, moisturization, lubrication, glare reduction (e.g., a colorant added to the solution) and / or a treatment of another ocular condition unrelated to dry eye or eye fatigue (e.g., a biologically active intraocular agent to treat glaucoma).

[0023] The subject disclosure also provides a method of treating dry eye or eye fatigue that includes applying the eyewear of any one of the embodiments disclosed herein to one or more eyes of the user. In addition, the subject disclosure provides a method of treating keratoconus comprising applying the eyewear of any one of the embodiments disclosed herein to one or more eyes of the user.

[0024] Still further, the subject disclosure provides a method of introducing a therapeutically or biologically active agent intraocularly to an eye of a user that includes introducing the therapeutically or biologically active agent to a supply of optical fluid and applying the eyewear of any one of the embodiments disclosed herein to one or moreeyes of the user. For example, the instantly disclosed eyewear can be used to treat dry eye and other ailments.

[0025] Lastly, the subject disclosure provides a method of irrigating an eye of a user who has suffered an eye insult comprising the eyewear of any one of the embodiments disclosed herein to one or more eyes of the user. Accordingly, the instantly disclosed eyewear can be used as an emergency eye wash to irrigate the eye.

[0026] BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

[0027] The foregoing summary, as well as the following detailed description of the exemplary embodiments of the subject disclosure, will be better understood when read in conjunction with the appended drawings. For the purpose of illustrating the invention, there are shown in the drawings exemplary embodiments. It should be understood, however, that the exemplary embodiments are not limited to the precise arrangements and instrumentalities shown.

[0028] FIG. 1 is a proximally-facing perspective view of eyewear in accordance with an exemplary embodiment of the subject disclosure;

[0029] FIGS. 2A and 2B are optical fluid delivery systems according to exemplary embodiments of the subject disclosure;

[0030] FIG. 3 is a proximally-facing view of the eyewear of FIG. 1 ;

[0031] FIG. 3A is a perspective view of the frame of the eyewear of FIG. 1 ; FIG. 3B is a perspective view of the sealing member, frame and upper frame of the eyewear of FIG. 1 ; FIG. 3C is a perspective view of the upper frame of the eyewear of FIG. 1 ; FIG. 3D is a perspective view of the sealing member of the eyewear of FIG. 1 .

[0032] FIG. 4 is a proximally facing view of the adjustment mechanism and lens containers of the eyewear of FIG. 1 ;

[0033] FIG. 5 is a distally facing perspective view of the adjustment mechanism and lens containers of the eyewear of FIG. 1 ;

[0034] FIG. 6 is a perspective view of a portion of the adjustment mechanism of the eyewear of FIG. 1 ;

[0035] FIG. 7A and 7B are detailed views of components of the adjustment mechanisms of the eyewear of FIG. 1 ;

[0036] FIG. 8 is an isolated, proximal facing view of the adjustment mechanism and lens container of the eyewear of FIG. 1 ;

[0037] FIG. 9 is an isolated, distally facing view of the adjustment mechanism and lens container of the eyewear of FIG. 1 ;

[0038] FIG. 9A is a perspective view of the horizontal adjustment plate of the adjustment mechanism of the eyewear of FIG. 1 ; FIG. 9B is a perspective view of the vertical adjustment plate of the adjustment mechanism of the eyewear of FIG. 1 ;

[0039] FIGS. 10A and 10B are profile views of eyewear in accordance with another exemplary embodiment of the subject disclosure;

[0040] FIGS. 11 A and 11 B are profile views of the sealing member, frame and lens container sealing members of the eyewear of FIGS. 10A and 10B;

[0041] FIGS. 12A and 12B profile views of the adjustment mechanism, support assembly and horizontal pin assemblies of the eyewear of FIGS. 10A and 10B;

[0042] FIG. 13 is a profile view of the support assembly of the eyewear of FIGS. 10A and 10B;

[0043] FIG. 14 is a profile view of the primary adjustment bar of the eyewear of FIGS. 10A and 10B;

[0044] FIG. 15 is a profile view of a lens container mount of the eyewear of FIGS. 10A and 10B;

[0045] FIGS. 16A and 16B is a profile view of the linkage assembly, primary adjustment bar and adjustment pin assembly of the eyewear of FIGS. 10A and 10B;

[0046] FIG. 17 is a profile view of the base linkage of the linkage assembly of the eyewear of FIGS. 10A and 10B;

[0047] FIG. 18 is a perspective exploded view of eyewear in accordance with yet another exemplary embodiment of the subject disclosure;

[0048] FIG. 19 is a schematic cross-sectional depiction of features of the eyewear of FIG. 18;

[0049] FIG. 20 is a perspective view of the eyewear of FIG. 18 in an assembled state;

[0050] FIG. 21 is a schematic of an exemplary lens container;

[0051] FIG. 22 is a light ray trace of a standard (normal cornea) eye model for incoming light rays from objects at theoretical infinity, ranging from 0 to 30 degrees;

[0052] FIG. 23 is a light ray trace of an eye with keratoconus (irregular shaped cornea) eye model for incoming light rays from objects at theoretical infinity, ranging from 0 to 30 degrees; and

[0053] FIG. 24 is a light ray trace of an eye with keratoconus (irregular shaped cornea) eye model for incoming light rays from objects at theoretical infinity, ranging from 0 to 30 degrees, in which eyewear of the subject disclosure is worn by a user.DETAILED DESCRIPTION OF THE INVENTION

[0054] Reference will now be made in detail to the various exemplary embodiments of the subject disclosure illustrated in the accompanying drawings. Wherever possible, the same or like reference numbers will be used throughout the drawings to refer to the same or like features. It should be noted that the drawings are in simplified form and are not drawn to precise scale. Certain terminology is used in the following description for convenience only and is not limiting. Directional terms such as top, bottom, left,right, above, below and diagonal, are used with respect to the accompanying drawings. The term “distal” shall mean away from the center of a body. The term “proximal” shall mean closer towards the center of a body and / or away from the “distal” end. The words “inwardly” and “outwardly” refer to directions toward and away from, respectively, the geometric center of the identified element and designated parts thereof. Such directional terms used in conjunction with the following description of the drawings should not be construed to limit the scope of the subject application in any manner not explicitly set forth. Additionally, the term “a,” as used in the specification, means “at least one.” The terminology includes the words above specifically mentioned, derivatives thereof, and words of similar import. In this regard, the terms “right” and “left” as used herein shall mean as considered from the viewpoint of the user or wearer of the corrective eyewear disclosed herein.

[0055] “About” as used herein when referring to a measurable value such as an amount, a temporal duration, and the like, is meant to encompass variations of ±20%, ±10%, ±5%, ±1%, and ±0.1 % from the specified value, as such variations are appropriate.

[0056] “Substantially” as used herein shall mean considerable in extent, largely but not wholly that which is specified, or an appropriate variation therefrom as is acceptable within the field of art. “Exemplary” as used herein shall mean serving as an example.

[0057] Throughout the subject application, various aspects thereof can be presented in a range format. It should be understood that the description in range format is merely for convenience and brevity and should not be construed as an inflexible limitation on the scope of the subject disclosure. Accordingly, the description of a range should be considered to have specifically disclosed all the possible subranges as well as individual numerical values within that range. For example, description of a range such as from 1 to 6 should be considered to have specifically disclosed subranges such as from 1 to 3, from 1 to 4, from 1 to 5, from 2 to 4, from 2 to 6, from 3 to 6 etc., as well as individual numbers within that range, for example, 1 , 2, 2.7, 3, 4, 5, 5.3, and 6. This applies regardless of the breadth of the range.

[0058] Furthermore, the described features, advantages and characteristics of the exemplary embodiments of the subject disclosure may be combined in any suitable manner in one or more embodiments. One skilled in the relevant art will recognize, in light of the description herein, that the subject disclosure can be practiced without one or more of the specific features or advantages of a particular exemplary embodiment. In other instances, additional features and advantages may be recognized in certain embodiments that may not be present in all exemplary embodiments of the present disclosure.

[0059] Referring now to the drawings, FIG. 1 depicts eyewear 100 in accordance with an exemplary embodiment of the subject disclosure and includes a band 01 , a facial sealing member 02, optical fluid tubes 19a, 19b and an ornamental cover 21 that can be removed by the user of a technician. The facial sealing member 02 is comprised of a soft material with sufficient rigidity such that a proximal side 04 of the sealing member forms a seal when impressed against a user’s face.

[0060] As shown in FIG. 2A, the optical fluid tubes 19a, 19b are, in this exemplary embodiment, in fluid communication with an optical fluid reservoir 23 that is immersed in a temperature-controlled bottle warmer 25. The optical fluid reservoir contains an optical fluid (e.g., saline alone or saline with hyaluronic acid and / or carboxymethyl cellulose) warmed to a temperature elevated from room temperature (e.g., body temperature) and is introduced to the eyewear 100 via optical fluid tube 19a with the assistance of a pump 27, which in this exemplary embodiment is a peristaltic pump.The pump 27 can be operated to fill the eyewear with optical fluid, and in this exemplary embodiment, can also be operated to recycle the saline, with “spent” or cooled optical fluid departing the device from optical fluid tube 19b to be replaced by warmed optical fluid from optical fluid tube 19a.

[0061] The delivery system shown in this exemplary embodiment is not required for operation of the eyewear 100. Other arrangements will present themselves to one of ordinary skill in the art. For example, as shown in FIG. 2B, a delivery tool (e.g., a syringe) can deliver heated optical fluid directly to the eyewear 100 from the salinereservoir 23. Alternatively, chambers to hold the optical fluid can be incorporated into the frame, headband, or another area of the eyewear device itself, which can be adapted to be ready to be deployed when the eyewear is placed on the subjects’ face. These chambers to hold the optical fluid can be permanent or disposable (e.g., one time use).

[0062] The sealing member 02 is shaped to engage with a user’s face and is thus shaped in this exemplary embodiment to complement the anatomy of a typical user’s face. Alternatively, the sealing member can be dimensioned to be customized for a particular user’s face, or provided in multiple sizes and configurations for user’s having slightly different facial features (e.g., designs for relatively smaller, “normal” and relatively larger heads or faces).

[0063] The particular configuration of the sealing member shown in this exemplary embodiment is only exemplary. Instead of having a general concave shape as shown in this exemplary embodiment, the sealing member can have a convex shape, such as would be provided with a sealing member that models a swimmer’s goggle. In another alternative embodiment, the sealing member can model a standard SCUBA goggle seal or other standard eye google configuration.

[0064] As shown in FIG. 3, the sealing member is provided along the top with a relatively flat section 03 intended to rest in the center of the user’s forehead, extending portions 05a, 05b extending on each end the of relatively flat section in concave fashion to accommodate the user’s temple and then extending downward to accommodate the user’s cheeks, concavely extending inward to accommodate the area under the user’s eyes. The sealing member further includes a recess 07 shaped to receive the nose of the user. The sealing member 02 thus forms a seal around a user’s eyes sufficient to maintain the optical fluid. Though not so limited, in this exemplary embodiment, the seal 02 is comprised of silicone or rubber-like polymer, similar to the type employed in diving (SCUBA) or other water-tight googles.

[0065] In this exemplary embodiment, an interior portion of the recess is shaped to receive an end of an optional lacrimal duct seal 33, which in turn contains a bridge andcushions at each end intended to apply pressure to the user’s lachrymal ducts to occlude them and prevent user discomfort upon extended use of the device in some users (e.g., a runny nose).

[0066] The frame 06 in this exemplary embodiment is shown in FIG. 3A and includes one or more ports 08. In this exemplary embodiment, ports 08a and 08b are functional, in which port 08a receives optical fluid tube 19a and includes a male component 29a interference fit to be inserted in into optical fluid tube 19a and maintain it in place. Port 08b includes at its outlet a similar shaped male component adapted to receive optical fluid tube 19b.

[0067] In this exemplary embodiment, in operation optical fluid is maintained below ports 08c and 08d. Ports 08c and 08d, along with apertures 93, serve to equalize pressure inside the chamber. Apertures can also be provided along the top of the sealing member, above the intended fill level of the chamber, to relieve pressure and vent the device.

[0068] Alternatively, a closed system can be provided in an alternative embodiment, in which the system is air tight, and a de-airing valve is opened when the system is being filled with saline, then closed to maintain a negative pressure (suction) to the user's face.

[0069] Frame 06 further includes a pair of orifices, 31 a shown in FIG. 3A, to mount buckle 10a, and also a central orifice 43 sized to receive pivot mounts 26a. Like apertures are provided on the other side of the frame 06 to receive buckle 10b and pivot mount 26b.

[0070] The sealing member 02, along a top portion including relatively flat section 03, is shaped to be received by an upper frame 35, as shown best in FIG. 3B and 3C. Upper frame 35 includes a pair of orifices 37a, 37b to receive fasteners to secure it to the frame 06, and also a pair of aperture mounts 39a, 39b to receive optical fluid tubes 19a, 19b. The upper frame further includes a shelf 41 to receive an upper portion of the sealing member 02.

[0071] One or more of the frame 06, upper frame 35 and sealing member 02 can be comprised of separate components, as in this exemplary embodiment. The sealing member 02 is provided with groove 41 dimensioned to receive the periphery of the frame 06, as shown best in FIG. 3D. The periphery of the frame 06 can be press or interference fit with the groove 41 , and / or bonded with an adhesive / sealant or fasteners. Alternatively, these components can be integrally formed (e.g., via a thermoset mold or like construction) and further, optionally custom-dimensioned for the particular user.

[0072] The buckles 10a, 10b can be mounted to the frame 06, as shown in this exemplary embodiment, or alternatively from another portion of the eyewear. While the particular design is not limited, in this exemplary embodiment the buckle includes a slot 12 adapted to receive the headband 01 or like restraining device to maintain the eyewear 100 sealed against the face of a user around the user’s eyes. The headband or like restraint can have an elasticity to securely hold the proximal end of the sealing member against a user’s face, while accommodating users having different head sizes. Alternatively, the length of the headband can be customized based on the particular user’s features (e.g., head size).

[0073] The frame 06 extends from the sealing member away from the user’s face to define a distal end 14 (FIG. 3A) that extends beyond the users eyes when the eyewear is worn by a user. The distal end 14 of the frame 06 includes a pair of openings 16a, 16b. In this exemplary embodiment, the openings 16a, 16b are each sized to receive a pair of lens container sealing members 20a, 20b, which in turn seal a pair of lens containers 18a, 18b, as shown best in FIG. 3.

[0074] In operation, a user places the proximal side 04 of the sealing member 02 around the user’s eyes and positions the headband (not shown) to maintain the position of the eyewear 100 in a comfortable position. Fluid is then introduced through port 08a and fills chamber 22. The chamber 22 is at least water tight, optionally air tight and bounded in area by the user’s face, the sealing member 02, the frame 06, the distal end 14 of the frame 06 and lens container sealing members 20a, 20b, which along with the lens containers 18a, 18b, seal openings 16a, 16b.

[0075] FIG. 4 depicts the eyewear 100 without the ornamental cover 21 , and the distal end of the eyewear is shown in perspective. The eyewear 100 includes an adjustment mechanism 24 to position the lens containers 18a, 18b. In this exemplary embodiment, the adjustment mechanism is mounted the frame 06 on each side via stationary pivot shafts 26a, 26b at a position generally corresponding to the user’s temples (FIG. 5). The pivot shafts 26a is shaped to be received by central orifice 43.

[0076] As would be appreciated by those of ordinary skill, the frame 06 can be shaped or countered to receive pivot shafts in any convention manner, such as, for example, by provision of bores and / or a snap-fit or push-to-connect connection. In this exemplary embodiment, the pivot shafts are the only stationary mount in the adjustment mechanism 24.

[0077] While the sealing member 02 in this exemplary embodiment circumscribes both eyes, the subject disclosure is not so limited. Alternatively, the sealing member 02 can seal one eye. Still further, separate sealing members and chambers can be provided for each eye.

[0078] The adjustment mechanism 24 is shown in FIG. 4 and particularly FIG. 5, and includes brackets 28a, 28b extending from a support 30. The brackets 28a, 28b in this exemplary embodiment, are located on the ends 32, 34 of the adjustment mechanism and serve as a mount for the stationary pivot shafts 26a, 26b. The brackets 28a, 28b are mounted along opposite ends 32, 34 of support 30. The brackets are mounted on a proximally-facing surface of the surface, as shown best in FIG. 5. In this exemplary embodiment, support 30 includes a crossbar 36 running longitudinally between the two ends 32, 34 of the support 30.

[0079] As shown in FIG. 6, a vertical adjustment plate 38, dimensioned to be in sliding engagement with the ends 32, 34 of the support 30, is provided. In this exemplary embodiment, the vertical adjustment plate 38 spans the longitudinal distance from one 32 to the other end 34 of the support 30. On each lateral end, a vertical adjustment gap 40, 42 is provided, centrally located with respect to the height of the vertical adjustment plate. Each adjustment gap 40, 42 is dimensioned to receive a shaftof an adjustment screw (i.e., left adjustment screw 44, and right adjustment screw 46), whereupon the head of the adjustment screw is large enough to forestall movement in the vertical (y) direction. Upon loosening the adjustment screws 44, 46 such that the head of the screws is not engaged with the vertical adjustment plate, the vertical adjustment plate 38 can be adjusted in the y-direction. Upon tightening the adjustment screws such that the head of the screws engages the vertical adjustment plate, movement in the vertical (y) direction is curtailed.

[0080] Simultaneous with positioning the proper placement of the vertical adjustment plate, loosening the left adjustment screw 44 and the right adjustment screw 46 also allows tilt adjustment, 0, of the adjustment mechanism 24, and hence lens containers 18a, 18b. The right and left adjustment screws 44, 46 are each provided with shafts 09, 1 1 . As shown in FIGS. 7A and 7B, shaft 09 associated with right adjustment screw 46 can engage with an interior surface of buckle 10a. Spring washers 13 are provided about each of these shafts, which are sized to be received within an aperture 15 centrally located about a nut 17 that is received in brackets 28a. Bracket 28b is configured in a like manner.

[0081] Tilt adjustment can be achieved about the pivot shaft when the left adjustment screw 44 and the right adjustment screw 46 is loosened. The apertures in the nut allow the shafts to rotate with friction. The spring washer located between the nut and shaft provides a spring force to provide stability to the mechanism. In operation, the left and right adjustment screws 44, 46 are loosened, and the user adjusts Y and tilt angle (0) to the desired position, and the screw is then tightened.

[0082] With reference to FIG. 6, the distal facing end of the vertical adjustment plate 38 includes a distally extending ridge 52. The distally extending ridge 52 serves as a superior boundary for a right horizontal adjustment plate 48 and a left horizontal adjustment plate 50. The posterior boundary of each horizontal adjustment plate include a bracket 54, 56 to further secure the horizonal adjust plates 48, 50 against vertical movement with respect to the vertical adjustment plate 38.

[0083] The right horizontal adjustment plate 48 includes a right superior horizontal adjustment gap 58 and a right posterior horizontal adjustment gap 60. The left horizontal adjustment plate similarly includes a left superior horizontal adjustment gap 62 and a left posterior horizontal adjustment gap 64. Each of the horizontal adjustment gaps are fit to receive horizontal adjustment screws. The horizontal adjustment screws contain spring washers 68a, 68b, 68c, 68d which provide appropriate friction to allow the horizontal adjustment plate 48 (and 50) to slide, but stay in place at the user’s set location, thereby allowing the user or user’s technician to adjust movement of the optical lens in the horizontal or x direction, thereby achieving PD adjustment.

[0084] With reference to FIGS. 6 and 8, the lens containers 18a, 18b are each circumscribed by rotation rings 70a, 70b about their distal end, each rotational ring containing toothed, distally-facing crowns 72. As shown best in FIG. 8, the toothed crowns are accessible, for example, by an optical technician facing the user, by manipulating a dial 74. The dial 74 according to this exemplary embodiment contains counter-crowns 76, shaped complimentary to crowns 72, located along the periphery of rotation rings 70a, 70b, to allow rotational adjustment of the lens containers 18a, 18b.

[0085] In this exemplary embodiment, the lens containers 18a, 18b are provided with external threads 82 as shown best in FIG. 9, the external threads 82 complementary to internal threads 84 located on the horizontal adjustment plates 48, 50.

[0086] The left horizontal adjustment plate 50 is shown in isolation in FIG. 9A and the vertical adjustment plate is shown in isolation in FIG. 9B. The proximal facing portion of the horizontal adjustment plate 50 includes a raised flange 78 shaped complimentary to flanges 80 located on the vertical adjustment plate 38. This configuration prevents rotation of the adjustment mechanism and allows the lens container 18b to move in and out (i.e., movement in the z direction to and from the eye). The right adjustment plate 48 and lens container 18a are similarly configured.Alternative, or supplemental to, the threads 82, 84, a sawtooth configuration can be provided to adjust movement in the z direction.

[0087] As with all structural components discussed above in connection with this exemplary embodiment, the presently disclosed subject matter is not necessarily limited to the particular adjustment mechanism 24 detailed above. Other configurations will present themselves to one of ordinary skill in the mechanical and optical arts that will similarly provide adjustment of the optical lens in one or more, preferably two, three of all of a: (1 ) vertical (y); (2) horizontal (x or PD); (3) tilt angle (0); and (4) towards and away from eye of user (z) directions. All such other configurations are within the scope of certain embodiments of disclosed subject matter.

[0088] FIGS. 10A and 10B depict eyewear 200 in accordance with another exemplary embodiment of the subject disclosure, shown for purposes of brevity, without a band, optical fluid tubes, and an ornamental cover, which can be provided in like manner as in eyewear 100 or otherwise according to ordinary skill in the art. The facial sealing member 202 is similarly comprised of a soft material with sufficient rigidity such that a proximal side 204 of the sealing member forms a seal when impressed against a user’s face.

[0089] The frame 206 and proximally facing portion of the sealing member 202 in this exemplary embodiment is shown in FIGS. 1 1 A and 11 B. The frame 206 includes one or more ports 208a, 208b adapted to receive an optical fluid tube. Frame 206 further includes a pair of orifices, 231 a, 231 b and a central orifice 243, which in this embodiment, collectively serve as a mount to an adjustment mechanism 224.

[0090] Similar to sealing member 02, the seaming member 202 is provided along the top with a relatively flat section 203 intended to rest in the center of the user’s forehead, extending portions 205a, 205b extending on each end the of relatively flat section in concave fashion to accommodate the user’s temple and then extending downward to accommodate the user’s cheeks, concavely extending inward to accommodate the area under the user’s eyes. The sealing member further includes a recess 207 shaped to receive the nose of the user. The sealing member 202 thus forms a seal around a user’s eyes sufficient to maintain the optical fluid. The recess can accommodate a lacrimal duct seal (not shown) as with eyewear 100.

[0091] Also similar to the exemplary configuration shown in connection with eyewear 100, the frame 206 extends from the sealing member away from the user’s face to define a distal end 214 that extends beyond the users’ eyes when the eyewear is worn by a user. The distal end 214 of the frame 206 includes a pair of openings 216a, 216b. In this exemplary embodiment, the openings 216a, 216b are each sized to receive a pair of lens container sealing members 220a, 220b, which in turn seal a pair of lens containers 218a, 218b. The sealing members are sufficiently flexible to accommodate movement of the lens containers by the lens adjustment mechanism 224 in the x (PD), y, z and 0 (tilt angle) directions.

[0092] The adjustment mechanism 224 is shown in FIGS. 12A and 12B. In this exemplary embodiment, the adjustment mechanism includes a support assembly 257, a primary adjustment bar 245, lens container adjustment mounts 247a, 247b engaged with the primary adjustment bar, a linkage assembly 251 engaged with the primary adjustment bar and the support assembly, and an adjustment pin assembly 253 capable of placing the linkage assembly 251 in an adjustable position, in which movement of the linkage assembly is facilitated, and a non-adjustable position in which movement of the linkage assembly is hindered. The adjustment mechanism further includes a pair of horizontal adjustment pin assemblies 255a, 255b connected to the lens container adjustment mounts 247a, 247b capable of placing the lens container adjustment mounts in an adjustment position, in which horizontal movement of the container adjustment mounts is possible, and a non-adjustable position in which horizontal movement of the container adjustment mounts is not possible.

[0093] The adjustment mechanism support assembly 257 is shown in FIG. 13 and includes an upper bar 259 with a central relatively flat section that extends to generally match the concave shape of the sealing member 202, which in turn generally matches the contours of the users forehead and temples. A pair of mounts 261 a, 261 b extend at an angle from the upper bar 259, the mounts spaced apart at distance to receive a drive link 21 17 from the adjustment pin assembly 253. A pair of vertical members 263a, 263b extend on opposite sides from the upper bar 259, each containing an inclined surface 265a, 265b that can serve as a seat for the ports 208a, 208b. The pair of verticalmembers 263a, 263b also a mount 267a, 267b towards the lower end of the vertical members for engagement with the orifices 231 . The mounts each include a recess cut into the outer periphery of the lower end of the vertical member that can be sized to receive the headband (not shown).

[0094] The primary adjustment bar 245 is shown in FIG. 14. Each end of the primary adjustment bar is provided with an “H” cross sectional shape, with a proximal side 269 having a shorter height than a distal side 271 , while the middle section 273 of the adjustment bar is of solid construction generally in the shape of a rectangular block and sized to serve as a seat to the linkage assembly 251 .

[0095] As shown in FIG. 14, two series of sharp teeth or cogs 275a, 275b are provided along the top surface of the distal side 271 , the cogs beginning near the middle section and running a sufficient length towards each end of the primary adjustment bar to accommodate at least most or all a potential user’s Pupillary Distance (PD). The teeth are shaped to engage with complementary cogs 277a, 277b found on the horizontal adjustment pin assemblies 255a, 255b (FIG. 12B). Stops 279a, 279b are provided along the distally-facing face of distal side 271 of the primary adjustment bar, the stops being spaced to secure the linkage assembly and prevent its movement in the x-direction.

[0096] FIG. 15 depicts a detailed view of lens container mount 247b and horizontal adjustment pin assembly 255b, which is of like construction to lens container mount 247a and horizontal pin assembly 255a.

[0097] The lens container mount 247b includes a circular ring 281 b sized to circumscribe lens container 218b (FIG. 10A) and of sufficient rigidity or strength so as to allow positioning of the lens container in the x, y, z and 0 directions. An engagement portion 283 extends from the top or 12 o’clock position of the circular ring, and includes a female receiver 285 shaped and dimensioned to receive and secure the proximal side 269 of the primary adjustment bar 245. Grips 287 are provided along the top surface of the female receiver to facilitate manual movement of the lens container mounts along the primary adjustment bar 245 in the x-direction (PD).

[0098] The horizontal pin assembly 255b includes a spring housing 289 that houses a spring 291 (FIG. 12B). The spring biases a member 293 containing the complimentary cogs 277b to be in secure engagement with the cogs 275b of the primary adjustment bar 245. An actuator 295 is provided that can be pressed to allow the complimentary cogs 277b to be disengaged from the cogs 275b of the primary adjustment bar 245, i.e. to relieve its bias by spring 291 , to allow adjustment in the horizontal direction.

[0099] The linkage assembly 251 , primary adjustment bar 245, and the adjustment pin assembly 253 is shown in isolation in FIGS. 16A and 16B. The linkage assembly includes a mount 297, which in turn includes a base plate 299 to secure the mount to the frame 206, an extension 2101 generally in the form of a rectangular solid block, and a base linkage 2103 extending distally and downward from the extension 2101. A L- shaped linkage 2105 is provided, engaged with the base linkage, and having a first segment 2107 extending primarily downward and also distally and a second segment 2109 primarily extending distally to a location distal to the primary adjustment bar 245, but also extending downward. A second linkage 211 1 extends upward and links the L- shaped linkage to a base linkage 21 13.

[0100] The base linkage 2113 is shown in isolation in FIG. 17, which links the L- shaped linkage 2105 to the adjustment pin assembly 253. The base linkage 21 13 includes a base portion 21 15, which in this exemplary embodiment is in the form of a solid rectangular block. The width of the base portion 2115 is dimensioned so as to securely fit within the stops 279a, 279b of the primary adjustment bar 245 (FIG. 14). A pair of lower brackets 21 17 extends proud from the base portion in the distal direction, and is dimensioned to receive the second linkage 21 1 1. A pair of upper brackets 21 19 extends from the top of the base portion 2115, and is dimensioned to receive a drive link 21 17 (FIG. 16A).

[0101] With reference to FIGS. 16A and 16B, the adjustment pin assembly 253 is disclosed, and includes the drive link 2117, which in turn includes a bottom end 2120 in linked engagement with the upper brackets 21 19. The drive link extends upward at aslight angle to provide an increased diameter about a middle portion characterized by having a longitudinal orifice 2121 and having grooves 2123 on the outer surface. The adjustment pin assembly further includes a threaded pin 2125 in engagement with the mounts 261 a, 261 b (FIG. 13) and the drive link 2117 via the longitudinal orifice 2121 . The threaded pin 2125 is provided with internally-grooved washers 2127a, 2127b complimentary to grooves 2123 and a screw 2129.

[0102] The adjustment pin assembly further includes a turn valve 2131 . The turn valve includes an angular member 2133 that, when turned and engaged, forestalls movement of the drive link 21 17 about the upper brackets 21 19. When disengaged, the drive link 2117 is capable of rotating about the upper brackets 2119, which in turn facilitates movement of the linkage assembly. The drive link can also be adjusted in the vertical direction via its positioning along the longitudinal orifice 2121 to adjust the lens upon disengagement of the turn valve 2131 . Via adjustment of the drive link 2117 and manipulation of primary adjustment bar 245, the position of the lens containers can be easily adjusted in the y, z and theta directions.

[0103] FIG. 24 depicts a schematic view of an exemplary lens configuration for purposes of illustrating a typical arrangement of lens within the lens containers (e.g, 18a, 18b, 218a, 218b) of the subject disclosure. As would be understood by one of ordinary skill in the optical arts, however, there are countless permutations of lens that can be employed, and the strength of those lens varied to achieve the desired visual correction. As also understood in the art, this process can be facilitated with the assistance of lens simulating software commercially available, for example, under the names of 3DOptix, Zemax OpticStudio (Ansys), Lumerical (Ansys), Comsol, Lambda Research Optics Optical Design Software, among others.

[0104] The lens configuration shown in FIG. 24 employs three lens units, though other combinations of single lenses and / or multiple element lens (e.g., doublets or triplets) may be employed. More particularly, the user’s eye 86 is immersed in a chamber of fluid 22 (e.g., a saline solution) having a refractive index similar to the human eye. The temperature of introduced fluid can, optionally, be controlled, for 1example to match body temperature, or be within or pre-defined ranges (e.g., from about 33QF - 104QF).

[0105] Proceeding in the order of sight, according to one possible embodiment, the user looks through a transparent convex lens 88 and into a second convex singlet lens 90, followed by a double concave lens 92. The lens are secured in the lens containers via optically appropriate internal housing 94. Lens strengths employed will vary according to the patients condition and the objective. Furthermore, single or combinations of multi-element, meniscus, spherical and aspheric lens designs can be improved to improve visual acuity or field of view.

[0106] The optical lens(es) can be formed from any material suitable for functioning as an optical lens including, without limitation, polymethyl methacrylate, polystyrene, optical glass, or combinations thereof.

[0107] Still further, for example, in embodiments in which the eyewear of the subject disclosure is used to treat dry eye, allergies, or eye fatigue, the lens containers may not contain any corrective lens feature. Accordingly, it is understood that the term “lens container” as used herein, depending on the context, can be broadly construed to refer to a structure in which the eye is directed and which produces a desired visual experience.

[0108] For example, instead of corrective lenses, the lens container can include a screen component to display output from, for example, smart phones and other available media for the user to watch while receiving optical liquid via the chamber and the attendant benefits. Alternatively, the lens container can include a blacked out or soothing visual experience when the eyes are directed to the lens container. Alternatively, in embodiments that do not seek to correct vision, such as nearsightedness,

[0109] In other embodiments, one or more corrective lenses are included in the lens container. For example, the eyewear of the subject disclosure can be used to ameliorate and / or correct keratoconus. While not being bound by any particular theory,FIGS 22-24 describe principles as to how the eyewear of the subject disclosure can be used to treat, for example, keratoconus and other sight conditions.

[0110] FIG. 22 is a light ray trace of a standard (normal cornea) eye model for incoming light rays from objects at theoretical infinity, ranging from 0 to 30 degrees. The cornea 96 serves as the initial filter to sharply focus the incoming light rays through the pupil 98 on the retina 99 to provide a “clear” (normally focused) image.

[0111] FIG. 23 is a light ray trace of an eye with keratoconus (irregular shaped cornea) eye model for incoming light rays from objects at theoretical infinity, ranging from 0 to 30 degrees. The irregular shaped cornea 96’ serves as the same initial filter, but does not sharply focus the incoming light rays through the pupil 98 on the retina 99 to provide a “clear” (normally focused) image. Instead the resulting image quality is poor (e.g., blurry).

[0112] FIG. 24 is a light ray trace of an eye with keratoconus (irregular shaped cornea) eye model for incoming light rays from objects at theoretical infinity, ranging from 0 to 30 degrees, in which eyewear of the subject disclosure is employed. The incoming light rays are first directed to the lens container 18, which functionally serves as an external and exogenous cornea. The light rays leaving the lens container 18 (external cornea) travels directly into the chamber 22 of the subject disclosure, which contains a water tight sealed chamber of optical solution (e.g., saline) that mimics endogenous eye solution. The function of the irregular shaped cornea 96’, which has immersed in the chamber 22, has been obviated, replaced with the lens container 18.

[0113] It should be understood that, according to exemplary embodiments, as the endogenous cornea has been effectively replaced by the eyewear of the subject disclosure, it is equally applicable to normal subjects to achieve improved vision, or it can be used solely for the attendant benefits (e.g., improved eye irrigation) without lenses.

[0114] In certain embodiments, the intended use of the eyewear of the subject disclosure is not limited. In embodiments, the eyewear is used for any beneficialpurpose or effect, perceived or demonstrable, by the user. Such beneficial purpose can range from merely passing time or providing a more pleasurable, eye-health enriched smart media experience, to treating a serious ocular or medical condition. In such embodiments in which an eye disorder or ailment is treated that does not relate to correcting visual acuity, then the eyewear of the subject disclosure would not contain lenses (but can be otherwise likewise provided, or provided with lenses to provide for multiple uses by different users).

[0115] In certain embodiments, the eyewear of the subject disclosure is worn as part of a method to treat eye pain or discomfort by a subject in need thereof. The eye pain or discomfort can be from a chronic condition (e.g., dry eye) or an acute insult (e.g., a chemical burn, such as an acid or alkali being spilled in the eye). In certain embodiments, the eyewear is provided as a disposable (e.g., single use) device that is, in certain embodiments, provided sterile and sealed in a package and pre-loaded with optical fluid such that the device is ready for immediate use.

[0116] For example, in certain embodiments, the eye pain or discomfort is the result of a chemical (alkali or acid) or other deleterious foreign object or liquid accidentally being introduced to the eye. In certain embodiments, the eyewear is donned immediately after the insult to treat (e.g., neutralize or buffer) the insult (e.g. alkali or acid to the eye). The instant eyewear can also be used immediately after immediately insult from a solid object to provide comfort and relief.

[0117] Common acid insults to the eye can occur from commonly used objects and include, but are not limited to, sulfuric acid (car batteries), sulfurous acid (bleach and refrigerants), hydrofluoric acid (glass polishing and mineral processing), acetic acid (vinegar) and hydrochloric acid (swimming pool additives). Common alkali insults, which account for slight majority of chemical insults to the eye, include ammonia (cleaning agents, fertilizers and refrigerants), potassium hydroxide (potash), lye (drain cleaners, air bags), magnesium hydroxide (firework sparklers, flares) and lime (plaster, mortar and cement).

[0118] In certain embodiments, the eyewear of the subject disclosure is worn as part of a method to treat keratoconus by a subject in need thereof.

[0119] In certain embodiments, the eyewear of the subject disclosure is worn as part of a method to treat dry eye by a subject in need thereof.

[0120] In certain embodiments, the eyewear of the subject disclosure is used as a medical device. In certain embodiments, the eyewear of the subject disclosure is worn in order to deliver, by an ocular route, a therapeutically or biologically active agent (e.g., a nutraceutical or a pharmaceutical) to the subject. For example, in certain embodiments, the eyewear of the subject application is worn to deliver, by an ocular route, a therapeutically or biologically active agent along with optical solution or saline over extended period of time to the subject (e.g., over at least 15 minutes, at least 30 minutes, at least 45 minutes, at least 1 hour, at least 2 hours, at least 3 hours, at least 4 hours, or at least 8 hours. Predetermined amounts of the active agent can be added to reservoir 23 or introduced with optical fluid or solution directly into a port via a delivery tool 29. As would be understood, such delivery of a therapeutically or biologically active agent can be delivered while allowing the subject to see (i.e., preserving or increasing the ability to see while receiving therapy) and more generally, more comfortably for the subject, and much more effectively, than traditional intraocular administration (e.g., eyedrops).

[0121] In certain embodiments, the eyewear of the subject disclosure is used as, or as part of, an emergency eye wash. For example and without limitation, the instantly disclosed eyewear can be provided by industrial, scientific and other institutions as part of an emergency care station and offers the ability for immediate treatment on site. In certain embodiments, the eyewear is provided, or preloaded, with optical fluid. When the optical fluid is contained in a separate container, it is quickly loaded into the eyewear before its first (e.g., first and final) use.

[0122] FIGS. 18 - 21 depict eyewear 300 in accordance with yet another exemplary embodiment of the subject disclosure, this embodiment being particularly suitable for use for embodiments in which the intended use of the eyewear is as an eye wash toremove deleterious agents (e.g., an alkaline or acid) that have accidentally been introduced into the eye.

[0123] With reference to FIG. 18, the eyewear 300 according to this exemplary embodiment includes a hard cover 321 . A distal face 322 of the hard cover includes a nose bridge 323 shaped anatomically to accept and rest upon a user’s nose, circular portions 325a, 325b sized and shaped to circumscribe the user’s eyes, and a planar portion 327 with a length sized for a typical forehead. The hard cover extends proximally from the distal face 322 to provide a proximally facing surface 324 that engages with an inner piece 333. A plane 345 is provided toward the distal face of the hard cover 321 , which circumscribes an open area 347 about the distal face 322.

[0124] The inner piece 333 includes a proximally facing skin adherent surface 335, which in this exemplary embodiment is Tegaderm™, though other breathable, yet water resistant surfaces can be employed (e.g., Opsite from Smith & Nephew, Nexcare Transparent dressing from 3M and IV3000 from Smith & Nephew). The proximally facing skin adherent surface is anatomically shaped to circumscribe the eyes. The skin adherent surface 335 adheres to the skin around the eyes and is waterproof, yet sufficiently breathable to accommodate the pressure increase upon the introduction of optical fluid. Optionally, if the skin adherent surface employed is not sufficiently breathable, pressure relieving valves and orifices can be provided if necessary to relieve pressure.

[0125] The skin adherent surface extends distally to an inner bag area 337. The inner bag area 337 contains a chamber 343 for storing prefilled sterile optical fluid containing an agent to neutralize the pH and flush the eye. In this exemplary embodiment, the inner bag area is a multilayered plastic film and includes one or more (e.g., four) ports in the form of burst points 339 located along a proximally facing surface 341 (FIG. 19) of the inner bag area and in fluid communication with the chamber.

[0126] In this exemplary embodiment, the burst points are created by pre-scored or laser-perforated areas, but can alternatively be provided, for example, by the provision of a thinner or different strength plastic. In any event, the burst points 339 will burst bya pressure generated by manual manipulation of a distally facing surface of the inner bag area that is not obstructed by the hard cover 321 , which in turn will allow optical fluid contained in the chamber 343 to be released from the chamber and into the eye.

[0127] In this exemplary embodiment, the chamber is preloaded with an amount of optical fluid sufficient to adequately flush the eye. In certain embodiments, from about 50-200 mL of optical fluid is provided, preloaded sterile into the chamber and ready for use.

[0128] The inner bag area 337 extends distally to form a shape similar to the plane 345, and when the eyewear 300 is assembled, a portion of the inner bag area is supported by the plane 345 of the cover. Accordingly, the inner bag area thus includes a recess to match nose bridge 323 and extends to generally match the shape of the circular sections 325a, 325b. As shown schematically in FIG. 19, the chamber 343 includes a distal portion 349 that extends distally beyond the open area 347 about the distal face 322 of the cover 324, such that the chamber is exposed and capable of manual manipulation by a user wearing the eyewear 300. The plastic around the chamber is of sufficient sturdiness to have the integrity to maintain a distance from the proximal end of the eyewear, to provide an open area 351 .

[0129] In operation, a user removes a sticker (not shown) to expose the working, adhesive surface of the skin adherent surface 335 which can then be pressed by the user against their face to circumscribe the eyes of the user and form a water tight seal around the user’s eyes. To release the optical fluid, the user presses the distal portion 349 of the chamber 343 containing optical fluid towards the eye, which in this embodiment includes a lactated Ringer’s or Hartmann’s Solution, or a balanced salt solution (BSS), which will neutralize an acid or alkaline introduced to the eye, and in any event, will irrigate the eye to remove any undesired object akin to a traditional, stationary eye wash. Via manual manipulation of the chamber, and / or via tilting of the head, all natural reactions for the user undergoing the eye insult, the optical fluid will be brought to a pressure exceeding the break pressure of the burst points, and directed to the injured eye.

[0130] Variations can be made to eyewear 300 in accordance with the instant application. For example, as noted above, pressure relieve valves can optionally be provided to relieve pressure upon extended use. Also, the burst points can be provided based on their containing points of reduced plastic thickness, or the burst points can contain a membrane or valve made, for example, from a softer or stretchier polymer having a lower rupture pressure (e.g., a burst point comprising silicone elastomers or polyurethane having weak zones). Still alternatively, the burst points be provided by the shaping of the plastic at the burst points to have a lower burst pressure, such as by thermoforming (e.g., an area of that includes thermoformed ABS, ADPE or PVC) or other techniques known in the art. Any method can be provided to provide one or more burst points that are easily ruptured by the increased pressure engendered by manual or other manipulation of the chamber.

[0131] Effective administration amounts of the therapeutically or biologically active agent for any purpose (e.g., for use to treat dry eye or for use as an emergency eye wash) can be determined based on the pharmacokinetics of the particular active agent and experience with the active agents when administered via other routes. A person of ordinary skill in the pharmaceutical arts can determine the proper amount of active agent to mix with the optical fluid based on, for example, known dosing amounts for ocular administration to humans in other forms (e.g., when applied as an eye drop or drug-eluting, implanted intraocular lens) and ordinary skill. See, e.g., World J Pharmacol. 2(2):47-64 (2013); American Academy of Opthalmology (2020-2021 series: Section 2, Part V: Ocular Pharmacology, Chapter 15 Pharmacokinetics: The route of drug delivery, from the Fundamentals and Principles of Opthalmology; Materials 4(1 1 ):1927-1940 (2011 ) Drug-Eluting Intraocular Lenses; each of which are hereby incorporated by reference in their entirety.

[0132] In certain embodiments, a therapeutically or biologically active agent is included in the optical fluid useful to treat dry eye disease. In other embodiments, for example when the eyewear is used to acutely treat eye injuries, the therapeutically or biologically active agent includes, or consists of, a lactated Ringer’s or Hartmann’s Solution, or a balanced salt solution (BSS) and optionally further includes a pH buffer.

[0133] In one embodiment, the optical fluid includes an effective amount of a corticosteroid (e.g., an effective amount of loteprednol etanonate ophthalmic suspension (e.g., 0.25%)). Effective amounts and concentrations can be determined based on FDA approved dosage amounts of loteprednol etanonate ophthalmic suspension present in eyedrops, sold commercially under the name of Eysuvis by Alcon.

[0134] In one embodiment, the optical fluid includes an effective amount of a semifluorinated alkane, such as perfluorohexyloctane ophthalmic solution. Effective amounts can be determined based on approved dosage amounts of perfluorohexyloctane ophthalmic solution present in eyedrops, sold commercially under the name of Meibo by Bausch+Lomb.

[0135] In one embodiment, the optical fluid includes an effective amount of an immune inhibitor, such as cyclosporine ophthalmic emulsion or a lifitegrast opthmalic solution. Effective amounts of cyclosporine ophthalmic emulsion can be determined based on approved dosage amounts of cyclosporine ophthalmic emulsion present in eyedrops, sold commercially under the name of Restasis by Allergan. Effective amounts of lifitegrast ophthalmic solution can be determined based on approved dosage amounts of lifitegrast ophthalmic solution present in eyedrops, sold commercially under the name of Xiidra by Bausch+Lomb.

[0136] In one embodiment, the optical fluid includes an effective amount of an nicotinic acetylcholine receptor (nAChR) agnoist, such as a varenicline solution. Effective amounts can be determined based on approved dosage amounts of varenicline solution present in nasal spray, sold commercially under the name of Tyrvaya by Oyster Point Pharma, Inc.

[0137] In one embodiment, the optical fluid includes an effective amount of an nicotinic acetylcholine receptor (nAChR) agnoist, such as a varenicline solution. Effective amounts can be determined based on approved dosage amounts of varenicline solution present in nasal spray, sold commercially under the name of Tyrvaya by Oyster Point Pharma, Inc.

[0138] In one embodiment, the optical fluid includes an effective amount of an nicotinic acetylcholine receptor (nAChR) agnoist, such as a varenicline solution. Effective amounts can be determined based on approved dosage amounts of varenicline solution present in nasal spray, sold commercially under the name of Tyrvaya by Oyster Point Pharma, Inc.

[0139] In one embodiment, the optical fluid includes, or consists of, a Ringer’s Solution and optionally further includes (an additional) pH buffer. In one embodiment, the Ringer’s solution is a lactated Ringer’s solution (LR), which can consist of sodium chloride (e.g., 6.0 g / L), sodium lactate (e.g., 3.1 g / L), potassium chloride (e.g., 0.3 g / L), calcium chloride (e.g., 0.2 g / L), and water for injection (e.g., q.s. to 1 L), in which the sodium lactate acts a pH buffer. In one embodiment, the Ringer’s Solution is a buffered Ringer’s solution (e.g., Ringer’s Acetate), which employs acetate or gluconate instead of sodium lactate as a buffer. In other embodiments, the Ringer’s solution is customized for eye irrigation, such as by adding an additional amount of lactate or by adding another ophthalmic pH buffer. This optical fluid is particularly suited for use to irrigate the eyes to overcome an insult to the eye (e.g., a chemical insult), and thus can be used in embodiments in which the instant eyewear is used as an emergency eye wash.

[0140] In one embodiment, the optical fluid is a balanced salt solution (BSS). In one embodiment, the balanced salt solution includes sodium chloride, potassium chloride, calcium chloride, magnesium chloride, sodium acetate or sodium citrate, sodium bicarbonate, optionally glucose, and water for injection. In a further embodiment, the BSS further includes bicarbonate, glucose and glutathione (BSS plus).

[0141] In one embodiment, the optical fluid includes Hartmann’s Solution and optionally further includes a pH buffer. In one embodiment, the optical solution (i.e., Hartmann’s Solution) includes sodium chloride (e.g., 6.0 g / l), sodium lactate (e.g., 3.1 g / l), potassium chloride (e.g., 0.4 g / l), calcium chloride (e.g., 0.27 g / l), and water for injection (e.g., q.s. to 1 L).

[0142] Accordingly, the eyewear of the subject disclosure creates a more durable interaction between medicine in an optical fluid and the surface of the eye for a longerperiod of time. This can allow for targeted, more thorough administration of a medication to subjects. This can be particularly useful for diseases which require constant or prolonged administration of drops such as Glaucoma or eventually for other modalities such as gene therapy where a longer interaction with the eye is helpful, if not needed.EXAMPLE

[0143] A subject and co-inventor of the subject disclosure, diagnosed with keratoconus and legally blind (uncorrected), applied the eyewear of FIG. 1 to his face without wearing contact lens or any other visual assistance. An isotonic saline solution (i.e., a saline solution that is isotonic to the cornea) was introduced to the chamber above eye level, but below the level of the venting apertures.

[0144] The subject was placed about 20 feet (6 meters) away from a standard Snellen eye chart and attempted to ascertain the proper letter using both eyes, starting at the 20 / 200 line and progressing to smaller font, as performed in a routine eye exam. The subject reported the ability ascertain the letters in the 20 / 40 line with accuracy.Without the eyewear of this exemplary embodiment, the subject was unable to ascertain the first large letter (20 / 200 line).

[0145] It will be appreciated by those skilled in the art that changes could be made to the embodiments described above without departing from the broad inventive concept thereof. It is to be understood, therefore, that this invention is not limited to the particular embodiments disclosed, but it is intended to cover modifications within the spirit and scope of the present invention. All references cited herein are hereby incorporated by reference in their entirety.

Claims

CLAIMS1 . Eyewear comprising: a sealing member shaped to circumscribe at least one eye; a chamber adapted to hold an optical fluid when the sealing member is pressed against a face of a user; and a port in fluid communication with the chamber to introduce the optical fluid to an eye of a user of the eyewear.

2. The eyewear of claim 1 , further comprising one or more lenses distally positioned with respect to the chamber.

3. The eyewear of claim 1 , further comprising a headband to secure the sealing member about the face of the user.

4. The eyewear of claim 1 , further comprising a frame extending from the sealing element and forming a boundary of the chamber.

5. The eyewear of claim 1 , wherein the chamber is preloaded with an amount of optical fluid and is introduced through the port upon exceeding a rupture pressure of the port.

6. Eyewear comprising: a sealing member shaped to circumscribe at least one eye;a chamber adapted to hold an introduced optical fluid when the sealing member is pressed against a face of a user; a port in fluid communication with the chamber to introduce an optical liquid; and one or more lens containers extending distally from the chamber.

7. The eyewear of claim 6, wherein the lens container contains one or more corrective lenses.

8. The eyewear of claim 6, further comprising a frame extending from the sealing element and forming a boundary of the chamber.

9. The eyewear of claim 8, further comprising an adjustment mechanism operatively connected to the frame and adapted to adjust the one or more lens containers in at least one direction.

10. The eyewear of claim 9, wherein the lens container includes a thread and the adjustment mechanism includes a complimentary thread engaged with the lens container to move the lens container in a direction to and away from the eye of the user.1 1 . The eyewear of claim 9, wherein the lens container is in communication with a linkage assembly to move the lens container in a direction to and away from the eye of the user.

12. The eyewear of claim 9, wherein the adjustment mechanism includes a plate in sliding engagement with the frame of the eyewear.

13. The eyewear of claim 9, wherein the adjustment mechanism includes a horizontal pin assembly comprising a lens container mount capable of being moved in a horizontal direction about an adjustment bar.

14. The eyewear of claim 9, wherein the adjustment mechanism includes one or more pivot shafts engaging the frame and allowing the adjustment mechanism to pivot with respect to the frame.

15. Eyewear comprising: a sealing member shaped to circumscribe the eyes; an inner bag area extending distally from the sealing member and including a chamber comprising an amount of optical fluid; and a cover shaped to receive the inner bag area, wherein the chamber includes one or more burst points to allow the optical fluid to be introduced to an eye of the user.

16. The eyewear of claim 15, wherein the burst points are ruptured by a pressure created by manipulating the chamber.

17. The eyewear of claim 15, wherein the burst points are positioned about a proximal face of the chamber.

18. The eyewear of claim 15, wherein the cover includes an open area about a distal face that is accessible to the user and the chamber includes a distal portion that extends distally beyond the open area of the cover.

19. The eyewear of claim 15, wherein the optical fluid includes a Ringer’s solution, a Hartmann’s solution or a balanced salt solution (BSS).

20. A kit comprising the eyewear of any one of claims 1 to 14 and a supply of optical fluid.21 . The kit of claim 20, wherein the optical fluid is a solution that is isotonic to the cornea and suitable for ocular administration to a mammal, preferably a human.

22. The kit of claim 20, wherein the optical fluid is an isotonic saline solution.

23. The kit of claim 20, wherein the supply of optical fluid further comprises a therapeutically or biologically active agent.

24. The kit of claim 20, wherein the therapeutically or biologically active agent includes one or more of an agent selected from the group consisting of: hyaluronic acid, carboxymethyl cellulose, polyethylene glycol, polyvinyl alcohol, propylene glycol, povidone, a cholinergic, preferably pilocarpine or cevimeline; loteprednol etabonate,perfluorohexyloctane, varenicline, perfluorohexyloctane, lifitegrast, cyclosporine, glycerin, a Ringer’s solution, a Hartmann’s solution or a balanced salt solution (BSS).

25. The kit of claim 20, wherein the optical fluid is maintained at a temperature of about 90QF to about 1 10QF.

26. A method of treating dry eye or eye fatigue comprising applying the eyewear of any one of claims 1 to 19 to one or more eyes of the user.

27. A method of treating keratoconus comprising applying the eyewear of any one of claims 6 to 14 to one or more eyes of the user.

28. A method of introducing a therapeutically active agent intraocularly to an eye of a user comprising introducing the therapeutically active agent to a supply of optical fluid and applying the eyewear of any one of claims 1 to 19 to one or more eyes of the user.

29. A method of irrigating an eye of a user who has suffered an eye insult comprising applying the eyewear or kit of any one of claims 15 to 19 to the eyes of the user.

30. The method of claim 29, wherein the eye insult is the result of a chemical injury to the eye.31 . The method of claim 30, wherein the chemical injury is an acid or alkali injury.

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