Observation contact lenses with integrated eye speculum

Abstract

Aspects of the present disclosure relate to an integrated contact lens device for ophthalmoscopic examination, including a lens portion, an upper lid speculum portion, and a lower lid speculum portion, and methods of use thereof. The integrated contact lens device facilitates improved visualization of the peripheral retina, including the upper and lower hemi-retina, both via manual examination and via a wide-angle camera, which may utilize the contact lens for viewing. The integrated contact lens device also prevents or reduces corneal dryness and patient discomfort during the examination.

Description

[Technical Field]

[0001] During ophthalmic screening, which involves ophthalmoscopy or digital imaging techniques, a physician may use various lenses or tools in an attempt to see inside a patient's eye. [Background technology]

[0002] Ophthalmoscopy is routinely performed to examine the retina of the eye. One type of ophthalmoscopy is indirect ophthalmoscopy. Indirect ophthalmoscopy is performed using a head-mounted illumination source, optics, and a handheld lens that collects light reflected from the back of the eye. This type of examination can take a total of 10 to 30 minutes to examine both of a patient's eyes. During this period, the patient must keep the examined eye wide open and refrain from blinking. Also, during such an examination, the ophthalmologist is often physically very close to the patient being examined in order to view the light reflections from the various hemiretinal fields, particularly the poorly visible upper and lower hemiretina. Summary of the Invention [Problem to be solved by the invention]

[0003] Problems with indirect ophthalmoscopy include, but are not limited to, limited visualization of the peripheral retina due to obstruction by the eyelids and eyelashes, corneal dryness which can lead to patient discomfort and reduced image quality, and involuntary eye and eyelid movements such as blinking, eye rolling, and contraction of muscles around the eye which are often involuntary responses to prolonged examination and discomfort caused by exposing the cornea to air without moisture (either natural tears or "artificial tears"). [Means for solving the problem]

[0004] Described herein are one or more embodiments of an integrated contact lens device comprising a lens portion, an upper eyelid speculum portion, and a lower eyelid speculum portion, and methods of use thereof.

[0005] One or more embodiments of the integrated contact lens device enable improved visualization of the peripheral retina, including the upper and lower hemi-retina, both through manual inspection and via a wide-angle camera, which may utilize a contact lens for viewing. Ultra-wide-field digital images are often obstructed by the presence of the upper and lower eyelids and eyelashes within the field of view. The integrated contact lens device described herein reduces or eliminates corneal asphericity, such as that caused by radial keratotomy (RK), penetrating keratoplasty (PKP), laser in situ keratomileusis (LASIK), peripheral keratotomy (LRI), arcuate keratotomy (AK), keratoconus (KCN), and corneal tears, resulting in improved retinal imaging. The integrated contact lens device also prevents or reduces corneal dryness, reducing patient discomfort. The integrated upper and lower lid speculum cups of the integrated contact lens device can hold the eyelids open, thereby enabling a faster and more complete peripheral retinal examination without involuntary patient movement that can cause discomfort. The disposable nature of the integrated contact lens device eliminates the disinfection and cleaning requirements for expensive medical lenses, including handheld equipment. Avoiding repeated handling, cleaning, and sterilization of the optical surface extends its usefulness. Thus, embodiments of the present disclosure provide devices and methods for improved ophthalmoscopy, including indirect ophthalmoscopy.

[0006] The foregoing summary is not intended to represent all possible embodiments and every aspect of the present disclosure. Rather, the foregoing summary is intended to illustrate some of the novel aspects and features disclosed herein. These and other features and advantages of the present disclosure will be readily apparent from the following detailed description and detailed description, when read in conjunction with the accompanying brief description of the drawings and the appended claims. [Brief explanation of the drawings]

[0007] [Figure 1A]1 provides a front view of a fully integrated contact lens device configured to be introduced into a human eye, according to one or more embodiments. [Figure 1B] 1A provides a cross-sectional side view of a fully integrated contact lens device introduced into an eye, taken along line AA of FIG. 1A, according to one or more embodiments. [Figure 1C] 1B provides a partial perspective view of an eyelid speculum cup of an upper eyelid speculum portion according to box BB of FIG. 1A, according to one or more embodiments. [Figure 2A] 1 provides a front view of a fully integrated contact lens device configured to be introduced into a left eye, according to one or more embodiments. [Figure 2B] 1 provides a front view of a fully integrated contact lens device configured to be introduced into a right eye, according to one or more embodiments. [Figure 3A] 1 provides a front view of a fully integrated contact lens device after introduction into an eye, according to one or more embodiments. [Figure 3B] 3B provides a cross-sectional side view of a fully integrated contact lens device introduced into an eye, taken along line of sight CC of FIG. 3A, according to one or more embodiments. [Figure 4A] 1 provides a front view of several components of a contact lens device before being combined into an integrated contact lens device, according to one or more embodiments. [Figure 4B] 4B provides a front view of a one-piece contact lens device after integration of the components provided in FIG. 4A, according to one or more embodiments. DETAILED DESCRIPTION OF THE INVENTION

[0008] With reference to both the figures and the specification, like numbers refer to like elements throughout.

[0009] In the following description, details are given as examples to facilitate understanding of the disclosed subject matter. However, it should be apparent to those skilled in the art that the disclosed implementations are illustrative and do not encompass all possible implementations. Therefore, it should be understood that reference to the described examples is not intended to limit the scope of the present disclosure. Any modifications and further variations to the described devices, apparatuses, and methods, and any further applications of the principles of the present disclosure, as would normally occur to one skilled in the art to which the present disclosure pertains, are fully contemplated. In particular, it is fully contemplated that features, components, or steps described with respect to one implementation may be combined with features, components, or steps described with respect to other implementations of the present disclosure.

[0010] 1A-1C illustrate an exemplary fully integrated contact lens device and portions thereof configured for introduction into a human eye. FIG. 1A provides a front view of the fully integrated contact lens device. FIG. 1B is a side cross-sectional view of the exemplary fully integrated contact lens device provided in FIG. 1A along view line AA. FIG. 1C provides a cross-sectional perspective view of the speculum cup of the upper speculum portion of the fully integrated contact lens device of FIG. 1A along view box BB.

[0011] In the context of this application, "fully one-piece" means that the contact lens device embodiment is formed as a single piece, i.e., the entire contact lens device embodiment is unified, seamless, and one, although for purposes of description, "portions," "segments," or "sections" may be identified and specified. While "fully one-piece" is essentially "one-piece," a one-piece contact lens device may also have first and second portions that are merged, bonded, connected, or otherwise joined into a single device using joining techniques known in the art, such as by the use of adhesives, welding, or fasteners.

[0012] Whether fully integrated or one-piece, the first and second portions of the contact lens device of one embodiment may comprise the same, similar, or different materials in various parts, segments, or sections of the contact lens device, such as the lens and speculum portions.

[0013] 1A and 1B includes a lens 1100, an upper eyelid speculum portion 1200, and a lower eyelid speculum portion 1300. FIG. 1C shows a cross section of the lens 1100 and the upper eyelid speculum portion 1200.

[0014] 1A, several axes and angle lines are shown that help define the possible geometrical portions of the fully integrated contact lens device 1000. A true vertical axis 5000 and a true horizontal axis 5100 are depicted as intersecting at the lens center 1102 of the lens 1100. Starting from the lens center 1102, a first upper speculum angle line 5500 and a second upper speculum angle line 5501 are shown aligned with opposite ends of the upper speculum portion 1200, respectively. Similarly, a first lower speculum angle line 5600 and a second lower speculum angle line 5601 are also shown aligned with opposite ends of the lower speculum portion 1300, respectively.

[0015] The true horizontal axis 5100 defines the two semicircles of the lens: the upper and lower portions. The true vertical axis 5000 also defines the two semicircles of the lens: the left and right portions. Using the true vertical axis 5000 and the various angle lines, several geometric angles relative to the true vertical between the various angle lines themselves can be useful in defining some of the relative dimensions of the speculum portions. The upper speculum arc angle 1234 (short-dashed arc) is determined between the first upper speculum angle line 5500 and the second upper speculum angle line 5501. The lower speculum arc angle 1334 (short-dashed arc) is determined between the first lower speculum angle line 5600 and the second lower speculum angle line 5601.

[0016] The same angle lines can be used to define the minor arc perimeters of the upper eyelid speculum portion 1200 and the lower eyelid speculum portion 1300. Along the lens circumference 1106 (the circumference of the lens 1100), the first upper eyelid speculum angle line 5500 and the second upper eyelid speculum angle line 5501 can be used to determine the inner minor arc perimeter 1238 (the two short-dashed / long-dashed arcs) of the upper eyelid speculum portion 1200, and the first lower eyelid speculum angle line 5600 and the second lower eyelid speculum angle line 5601 can also be used to determine the inner minor arc perimeter 1338 of the lower eyelid speculum portion 1300. In a similar manner, the first upper eyelid speculum angle line 5500 and the second upper eyelid speculum angle line 5501 can be used to determine the outer minor arc perimeter 1239 (the two short-dashed / long-dashed arcs) along the leading tip 1212 of the anterior protrusion 1210 of the upper eyelid speculum portion 1200, and the first lower eyelid speculum angle line 5600 and the second lower eyelid speculum angle line 5601 can be used to determine the outer minor arc perimeter 1339 along the leading tip 1312 of the anterior protrusion 1310 of the lower eyelid speculum portion 1300.

[0017] The upper eyelid speculum arc angle 1234 and the lower eyelid speculum arc angle 1334 can be used in conjunction with the true vertical axis 5000 to help describe the relative positions of the upper eyelid speculum portion 1200 and the lower eyelid speculum portion 1300 along the lens circumference 1106. A first upper eyelid speculum portion arc angle 1235 is determined between the true vertical axis 5000 and a first upper eyelid speculum angle line 5500, and a second upper eyelid speculum portion arc angle 1236 is determined between the second upper eyelid speculum angle line 5501 and the true vertical axis 5000. The two portion arc angles 1235, 1236 add up to the upper eyelid speculum arc angle 1234. A first lower speculum partial arc angle 1335 can be determined between the true vertical axis 5000 and a first lower speculum angle line 5600, and a second lower speculum partial arc angle 1336 is determined between the second upper speculum angle line 5601 and the true vertical axis 5000. The two partial arc angles 1335, 1336 add up to a lower speculum arc angle 1334.

[0018] 1A , extending from the lens center 1102 are several radial lines. A lens radius 1104 meets a lens circumference 1106, which represents the maximum boundary of the lens 1100, either at the transition point 1110 to the speculum portion (dashed curve) or at the periphery 1108 of the lens 1100. Also extending from the lens center 1102 is an upper speculum tip radius 1232, which meets the leading tip 1212 of the anterior projection 1210 of the upper speculum portion 1200. The difference between the upper speculum tip radius 1232 and the lens radius 1104 is the height 1230 of the upper speculum portion 1200, which extends away from the transition point 1110 to the lens circumference 1106. The lower speculum tip radius 1332 meets the leading tip 1312 of the anterior projection 1310 of the lower speculum portion 1300. The difference between the lower speculum tip radius 1332 and the lens radius 1104 is the height 1330 of the lower speculum portion 1300.

[0019] In Figure 1B, several additional axes and angle lines can help define useful attributes of the fully integrated contact lens device 1000. At the lens center 1102 in Figure 1B, a true central axis 5200 intersects the lens 1100. The true vertical axis 5000 and true central axis 5200 in Figure 1B intersect each other at the center 5402 of the anterior lens circle 5400 and the center 5302 of the posterior lens circle 5300. An upper speculum transition line 5700 and a lower speculum transition line 5701 both extend from the centers 5302, 5402 through the fully integrated contact lens device 1000. A lens arc angle 5705 is determined between the upper speculum transition line 5700 and the lower speculum transition line 5701.

[0020] In FIG. 1B , the lens posterior circle 5300 and the lens anterior circle 5400 are displayed coaxially. The lens posterior circle 5300 has a center 5302, a radius 5304, and a circumference 5306 that describes at least a portion of the posterior curvature 1136. The lens anterior circle 5400 has a center 5402, a radius 5404, and a circumference 5406 that describes at least a portion of the anterior curvature 1126. In one or more embodiments, the centers of the anterior and posterior circles are coaxial. In such a configuration, the lens anterior circle 5400 and the lens posterior circle 5300 are coaxial, and the resulting lens thickness is uniform. In one or more embodiments, the center 5402 of the lens anterior circle 5400 and the center 5302 of the lens posterior circle 5300 are not coaxial. In such a configuration, the thickness of the lens 1100 varies between the center of the lens 1100 and the transition to the speculum portion.

[0021] 1B and 1C illustrate how it can be useful to identify various thickness values ​​in portions of the lens 1100. FIG. 1B illustrates the center thickness 1140 and speculum transition thickness 1144 of the lens 1100. FIG. 1C illustrates the peripheral thickness 1142 of the lens 1100.

[0022] 1B and 1C also show the configurations of upper and lower eyelid speculum portions 1200 and 1300, respectively. Upper and lower anterior projections 1210 and 1310 have anterior upper and lower leading tips 1212 and 1312, respectively, with upper and lower anterior projection tip thicknesses 1214 and 1314. Upper and lower posterior projections 1220 and 1320 have posterior upper and lower leading tips 1222 and 1322, respectively, with upper and lower posterior projection tip thicknesses 1224 and 1324. A mouth 1226, 1326 is defined between each forward leading tip 1212, 1312 and each corresponding rearward leading tip 1222, 1322, and each mouth 1226, 1326 has a mouth width 1228, 1328, respectively.

[0023] The upper and lower eyelid speculum cups 1240 and 1340 are defined by the inner surfaces 1242 and 1342 of the anterior projections 1210 and 1310 and the posterior projections 1220 and 1320, respectively. Bottoms 1244 and 1344 are defined at the intersection of the inner surfaces 1242 and 1342 of the anterior projections 1210 and 1310 and the posterior projections 1220 and 1320 of the upper and lower eyelid speculum cups 1240 and 1340, respectively. The depths 1246 and 1346 of the eyelid speculum cups 1240 and 1340 are determined by measuring from the eyelid speculum cup bottoms 1244 and 1344 to the associated eyelid speculum cup lip 1226 and 1326, respectively.

[0024] In some embodiments, the radius of the lens 1100 of the exemplary integrated contact lens device 1000 is larger than the radius of the cornea of ​​the human eye into which the integrated contact lens device is to be installed. Those skilled in the art will appreciate that the human cornea is not typically circular on the outside of the eye, but rather is elliptical, with a horizontal major axis diameter (typically about 11.75 mm) that is larger than the smaller vertical minor axis diameter (typically about 11.0 mm). Similarly, some people have a condition known as megacornea or microcornea. In one or more embodiments, the diameter of the lens portion of the one-piece contact lens device can range from about 8.00 mm to about 15.00 mm, e.g., from about 8.25, 8.50, 8.75, 9.00, 9.25, 9.50, 9.75, 10.00, 10.25, 10.50, 10.75, 11.00, 11.25, and 11.50 mm to about 11.75, 12.00, 12.25, 12.50, 12.75, 13.00, 13.25, 13.50, 13.75, 14.00, 14.25, 14.50, 14.75, and 15.00 mm (including and inclusive of all values ​​therebetween). Such a diameter range can ensure coverage for the most unusual corneal conditions.

[0025] In one or more embodiments, when the one-piece contact lens device 1000 is introduced onto the surface of the eye, the majority of the lens circumference 1106 is positioned along the sclera. In one or more embodiments, when the one-piece contact lens device 1000 is introduced onto the surface of the eye, the entire lens circumference 1106 is positioned along the surface of the sclera. This not only ensures that the cornea is protected from contact with the posterior surface of the one-piece contact lens 1000, but also allows the periphery 1108 of the lens 1100, the transition point 1110, and portions of the outer surfaces of the posterior projections 1220, 1320 of the upper and lower eyelid speculum portions 1200, 1300 to contact or fluidly couple with the surface of the sclera rather than the cornea.

[0026] 1A and similar figures depict lens 1100 as being generally circular in nature when viewed from front to back, and lens 1100 is generally described in circularly related geometric terms. This is done solely for ease of explanation. Those skilled in the art will recognize that in other configurations not shown, embodiments of the integrated contact lens device may include non-circular lenses, such as oval, square, rectangular, or non-geometric shapes, when viewed toward the front surface of the lens.

[0027] 1A , the upper speculum arc angle 1234, measured from the center 1102 of the lens 1100, defines the relative circumferential length of the upper inner minor arc perimeter 1238. Similarly, the lower speculum arc angle 1334 defines the relative circumferential length of the upper inner minor arc perimeter 1338. In one or more embodiments, the upper speculum arc angle 1234 can be in the range of about 10 degrees to about 65 degrees, for example, from about 10, 15, 20, 25, 30, and 35 degrees to about 40, 45, 50, 55, 60, and 65 degrees (including and inclusive of all values ​​in between). In one or more embodiments, the lower speculum arc angle 1334 can be in the range of about 10 degrees to about 65 degrees, for example, about 10, 15, 20, 25, 30, and 35 degrees to about 40, 45, 50, 55, 60, and 65 degrees (including and inclusive of all values ​​therebetween). In one or more embodiments, the upper speculum arc angle 1234 and the lower speculum arc angle 1334 are approximately the same.

[0028] 1A, the upper eyelid speculum portion 1200 has an upper eyelid speculum inner minor arc perimeter 1238, which is fully integrated with the lens 1100 at the lens circumference 1106. Similarly, the lower eyelid speculum portion 1300 has a lower eyelid speculum inner minor arc perimeter 1338. In one or more embodiments, the integrated contact lens device 1000 can have an upper speculum inner minor arc circumference in the range of about 3.00 mm to about 10.00 mm, for example, about 3.00, 3.25, 3.50, 3.75, 4.00, 4.25, 4.50, 4.75, 5.00, 5.25, 5.50, 5.75, 6.00, and 6.25 mm to about 6.50, 6.75, 7.00, 7.25, 7.50, 7.75, 8.00, 8.25, 8.50, 8.75, 9.00, 9.25, 9.50, 9.75, and 10.00 mm (including and inclusive of all values ​​therebetween). In one or more embodiments, the integrated contact lens device 1000 can have a lower speculum inner minor arc circumference in the range of about 3.00 mm to about 10.00 mm, for example, about 3.00, 3.25, 3.50, 3.75, 4.00, 4.25, 4.50, 4.75, 5.00, 5.25, 5.50, 5.75, 6.00, and 6.25 mm to about 6.50, 6.75, 7.00, 7.25, 7.50, 7.75, 8.00, 8.25, 8.50, 8.75, 9.00, 9.25, 9.50, 9.75, and 10.00 mm (including and inclusive of all values ​​therebetween). In one or more embodiments, the upper inner minor-arc perimeter 1238 and the lower inner minor-arc perimeter 1338 are approximately the same.

[0029] The position of the upper eyelid speculum portion 1200 along the lens circumference 1106 can be described relative to several axes, such as the true vertical axis 5000. In FIG. 1A , an exemplary contact lens device 1000 is shown having an upper eyelid speculum portion 1200 with a bisecting upper eyelid speculum arc angle 1234, i.e., the first upper eyelid speculum portion arc angle 1235 and the second upper eyelid speculum portion arc angle 1236 have approximately the same value. In one or more embodiments, the upper eyelid speculum portion 1200 is positioned so that it is centered about the true vertical axis in the upper semicircle of the lens 1100. Similarly, in one or more embodiments, the lower eyelid speculum portion 1300 is positioned so that it is centered about the true vertical axis in the lower semicircle of the lens 1100. In one or more embodiments, both the upper eyelid speculum portion 1200 and the lower eyelid speculum portion 1300 are positioned so that they are centered about the true vertical axis 5000 on opposite semicircles of the lens 1100, respectively.

[0030] As previously mentioned, the speculum projections have an outer length measured from the transition point along the lens circumference from the lens 1100 to the speculum projections (for both the upper speculum portion 1200 and the lower speculum portion 1300). In FIG. 1B, the upper speculum portion 1200 has a height 1230 measured along the anterior projection 1210, and the lower speculum portion 1300 has a height 1330 measured along the anterior projection 1310. In one or more embodiments, the height of the upper speculum portion 1200 of the one-piece contact lens device embodiments ranges from about 1 mm to about 3 mm, e.g., from about 1.00, 1.25, 1.50, and 1.75 mm to about 2.00, 2.25, 2.50, 2.75, and 3.00 mm (including and inclusive of all values ​​in between). In one or more embodiments, the height of the lower eyelid speculum of the one-piece contact lens device embodiments ranges from about 1 mm to about 3 mm, e.g., from about 1.00, 1.25, 1.50, and 1.75 mm to about 2.00, 2.25, 2.50, 2.75, and 3.00 mm (including and inclusive of all values ​​therebetween). In one or more embodiments, the height of the upper and lower eyelid speculum is approximately the same.

[0031] The eyelid speculum cups 1240, 1340 (for both the upper eyelid speculum portion 1200 and the lower eyelid speculum portion 1300) have cup depths 1246, 1346, respectively, measured from the bottoms 1244, 1344 of the cups 1240, 1340, respectively, where the corresponding anterior and posterior protrusions meet along the inner surface of the eyelid speculum cup, to the mouth of the eyelid speculum cup, defined as the entry point into the eyelid speculum cup and located between the tips of the anterior and posterior protrusions. 1B, the upper eyelid speculum portion 1200 has an eyelid speculum cup depth 1246 measured from the upper eyelid speculum cup bottom 1244 to the associated eyelid speculum cup mouth 1226, and the lower eyelid speculum portion 1300 has an eyelid speculum cup depth 1346 measured from the lower eyelid speculum cup bottom 1344 to the associated eyelid speculum cup mouth 1326. In one or more embodiments, the cup depth 1246 of the upper eyelid speculum portion 1200 of the integrated contact lens device 1000 is in the range of about 0.5 mm to about 2.5 mm, for example, about 0.50, 0.75, 1.00, and 1.25 mm to about 1.50, 1.75, 2.00, 2.25, and 2.50 mm (including and inclusive of all values ​​therebetween). In one or more embodiments, the cup depth 1346 of the lower eyelid speculum portion 1300 of the integrated contact lens device 1000 ranges from about 0.5 mm to about 2.5 mm, e.g., from about 0.50, 0.75, 1.00, and 1.25 mm to about 1.50, 1.75, 2.00, 2.25, and 2.50 mm (including and inclusive of all values ​​therebetween). In one or more embodiments, the cup depth 1246 of the upper eyelid speculum portion 1200 and the cup depth 1346 of the lower eyelid speculum portion 1300 are approximately the same. The depth of each speculum cup should be sufficient to restrain at least a portion of the patient's eyelid. Similarly, the depth of each speculum cup should be suitable to retain eyelashes that may become loose during treatment.

[0032] For ease of use and ease of manufacture, one or more exemplary contact lens devices 1000 may be configured with one or more relative symmetries, as shown in FIG. 1A . In one or more embodiments, the upper eyelid speculum portion 1200 is symmetrical about a true vertical axis 5000 of the contact lens device 1000. That is, along the true vertical axis 5000, the upper eyelid speculum portion 1200 is a mirror image of itself and has comparable dimensions (e.g., minor arc circumference, height). In one or more embodiments, the lower eyelid speculum portion 1300 is symmetrical about the true vertical axis 5000 of the contact lens device. In one or more embodiments, the upper eyelid speculum portion 1200 and the lower eyelid speculum portion 1300 are symmetrical about a true horizontal axis 5100 of the contact lens device 1000. That is, the upper eyelid speculum portion 1200 and the lower eyelid speculum portion 1300 are mirror images of each other along the true horizontal axis 5100 .

[0033] The materials of the one-piece contact lens device 1000 can include homopolymers, polymer blends, or copolymers made from the reaction of one or more monomers. A homopolymer is a polymer containing the reaction product of only one monomer. A copolymer is a polymer containing the reaction product of two or more monomers. A copolymer can optionally be the product of two polymers, such as two different homopolymers, reacted together, such as in a block, graft, or crosslinked (using a crosslinking agent) configuration. A polymer blend is a physical mixture of two or more polymers, such as by melt extrusion or compounding; a blend does not necessarily require a reaction between the two or more polymers.

[0034] Useful monomers for making one or more polymers for one-piece contact lens devices include, but are not limited to, methacrylic acid (MAA), methyl methacrylate (MMA), vinyl alcohol (VA), diacetone acrylamide (DA), N-carboxyl vinyl ester (NCVE), phosphorylcholine (PC), ethylene glycol (EG), N,N-dimethylacrylamide (DMAA), 2-hydroxyethyl methacrylate (HEMA), N-vinylpyrrolidone (NVP), ethylene glycol dimethacrylate (EG), ethylene glycol dimethacrylate (ME ... Examples of suitable vinyl carbamates include dimethylsiloxydi(silylbutanol)bis(vinylcarbamate) (BVC), dimethylsiloxydi(silylbutanol)bis(vinylcarbamate) (BVC), dimethylsiloxane (DMS), tris(hydroxymethyl)aminomethane, 3-[tris(trimethylsiloxy)silyl]propyl methacrylate (TRIS), 3-[tris(trimethylsiloxy)silyl]propyl vinylcarbamate (TRIS-VC), and dimethylsiloxydi(silylbutanol)bis(vinylcarbamate) (BVC).

[0035] Figure 2A provides a front view of an exemplary fully integrated contact lens device 2000A configured to be introduced into a left eye. Figure 2B provides a front view of another exemplary fully integrated contact lens device 2000B configured to be introduced into a right eye. While Figures 2A and 2B and the integrated contact lens devices 2000A and 2000B may appear similar to Figure 1A and the integrated contact lens device 1000, respectively, there are important configuration differences in both the orientation of the upper and lower eyelid speculum portions that may, in some cases, make the integrated contact lens devices 2000A and 2000B more suitable for use in a patient's left and right eyes, respectively.

[0036] Similar to how upper speculum arc angle 1234 and lower speculum arc angle 1334 of integrated contact lens device 1000 define the circumferential lengths of upper inner minor arc outer periphery 1238 and lower inner minor arc outer periphery 1338, respectively, in FIG. 2A , upper speculum arc angle 2234A and lower speculum arc angle 2334A of integrated contact lens device 2000A define the circumferential lengths of upper inner minor arc outer periphery 2238A and lower inner minor arc outer periphery 2338A, respectively. 2B, upper and lower speculum arc angles 2234B and 2334B of integrated contact lens device 2000B define the circumferential lengths of upper and lower inner minor arc circumferences 2238B and 2338B, respectively. In one or more embodiments, the upper and lower speculum arc angles of integrated contact lens device 2000A and / or 2000B are not approximately the same. In one or more embodiments, the upper and lower inner minor arc circumferences of integrated contact lens device 2000A and / or 2000B are not approximately the same.

[0037] As previously utilized, the upper eyelid speculum portion along the lens circumference can be described relative to several axes, such as the upper portion of the true vertical axis 5000. In FIG. 2A , an exemplary contact lens device 2000A is shown having a bisected upper eyelid speculum arc angle 2234A, i.e., the upper eyelid speculum arc angle 2234A is divided into a first upper eyelid speculum portion arc angle 2235A and a second upper eyelid speculum portion arc angle 2236A; however, in this example, because the upper eyelid speculum portion 2200A is not centered with respect to the true vertical axis 5000, the first upper eyelid speculum portion arc angle 2235A and the second upper eyelid speculum portion arc angle 2236A do not have approximately the same value after bisecting. In practice, one skilled in the art can note that the upper eyelid speculum portion 2200A is shifted toward the right side of the device 2000A. Thus, the second upper eyelid speculum portion arc angle 2236A has a greater value than the first upper eyelid speculum portion arc angle 2235A. In one or more embodiments, the upper eyelid speculum portion 2200A is positioned so that it is not centered about the true vertical axis 5000 on the upper semicircle of the lens 2100A. Figure 2B similarly illustrates the case for contact lens device 2000B where the first upper eyelid speculum portion arc angle 2235A is greater than the second upper eyelid speculum portion arc angle 2236A because the upper eyelid speculum portion 2200B has been shifted toward the left side of the device 2000B.

[0038] 2A and 2B, one skilled in the art can also observe that in one or more embodiments, the lower eyelid speculum portion 2300A or 2300B is positioned in the lower semicircle of the lens 2100A or 2100B, respectively, such that it is not centered relative to the true vertical axis 5000. In FIG. 2A, an exemplary contact lens device 2000A is shown having a bisected lower eyelid speculum arc angle 2334, i.e., the lower eyelid speculum arc angle 2334 is divided into a first lower eyelid speculum portion arc angle 2335A and a second lower eyelid speculum portion arc angle 2336A; however, in this example, because the lower eyelid speculum portion 2200A is not centered relative to the true vertical axis 5000, the first lower eyelid speculum portion arc angle 2335A and the second upper eyelid speculum portion arc angle 2336A do not have approximately the same value after bisecting. In practice, one skilled in the art can note that the lower eyelid speculum portion 2300A has been shifted toward the right side of the device 2000A. Accordingly, the second upper eyelid speculum portion arc angle 2336A has a greater value than the first upper eyelid speculum lower angle 2335A. In one or more embodiments, the lower eyelid speculum portion 2300a is positioned so that it is not centered with respect to the true vertical axis 5000 on the lower semicircle of the lens 2100A. Figure 2B similarly illustrates an embodiment of a contact lens device 2000B where the upper eyelid speculum portion 2300B has been shifted toward the left side of the device 2000B, resulting in the first lower eyelid speculum portion arc angle 2335A being greater than the second upper eyelid speculum portion arc angle 2336A.

[0039] There is a distinct lack of symmetry in the one-piece contact lens device 2000A, 2000B that may be useful in customizing the one-piece contact lens device for a patient's particular eye shape, generally or specifically. In one or more embodiments, the upper eyelid speculum portion 2200A or 2200B is not symmetrical about the true vertical axis 5000 of the contact lens device. In one or more embodiments, the lower eyelid speculum portion 2300A or 2300B is not symmetrical about the true vertical axis 5000 of the contact lens device. In one or more embodiments, the upper eyelid speculum portion 2200A or 2200B and the lower eyelid speculum portion 2300A or 2300B are not symmetrical about the true horizontal axis 5100 of the contact lens device. That is, the upper eyelid speculum portion 2200A or 2200B and the lower eyelid speculum portion 2300A or 2300B are not mirror images of each other along the true vertical axis 5000. Again, this can reflect different configurations of the upper and lower eyelids.

[0040] While there may be a lack of symmetry, the left- and right-eye configurations of the integrated contact lens device embodiments have some angular relationships that can be characterized. This can be clearly seen in both Figures 2A and 2B, where both the upper and lower eyelid speculum portions are shifted sufficiently to the right (in the case of Figure 2A) and sufficiently to the left (in the case of Figure 2B). In one or more embodiments, the integrated contact lens device has both a first upper eyelid speculum portion arc angle that is greater than the second upper eyelid speculum portion arc angle and a first lower eyelid speculum portion arc angle that is greater than the second lower eyelid speculum portion arc angle. Such a configuration describes the right contact lens of the integrated contact lens device 2000B embodiment of Figure 2B. In one or more embodiments, the integrated contact lens device has both a first upper eyelid speculum partial arc angle that is less than the second upper eyelid speculum partial arc angle and a first lower eyelid speculum partial arc angle that is less than the second lower eyelid speculum partial arc angle. Such a configuration describes the left contact lens of the embodiment of the integrated contact lens device 2000A of FIG. 2A.

[0041] Both integrated contact lens devices 2000A, 2000B show markings or labeling on the upper and / or lower eyelid speculum portions, which are not previously shown in other figures but are envisioned. FIG. 2A shows integrated contact lens device 2000A with letters 2250A and 2251A present at either end of upper eyelid speculum portion 2200A, and letters 2350A and 2350B present in a similar manner on lower eyelid speculum portion 2300A. One skilled in the art can observe that for a left-eye integrated contact lens device, the letter "N" faces the viewer's left side and the letter "T" faces the viewer's right side. One skilled in the art can then infer that, in this case, the letter "N" could represent the term "nasal" and the letter "T" could represent the term "temporal."

[0042] FIG. 2B shows an integrated contact lens device 2000B having letter 2250B ("U") present on the upper eyelid speculum portion 2200B, while letter 2350B ("L") is present on the lower eyelid speculum portion 2300B, which allows one skilled in the art to infer that these letters, in combination with letter 2250B, refer to "upper" and "lower" eyelid speculum cups. Arrows 2252B, 2352B (→), pointing outward and to the left from the physician's perspective, are also present on both the upper eyelid speculum portion 2200B and the lower eyelid speculum portion 2300B. In combination with the letters, one skilled in the art can infer that these arrows point toward the temporal side of the eye. Given that the markings and lettering are present on the anterior side of the integrated contact lens device, the device is configured for use with a patient's right eye.

[0043] Such markings can help the physician identify which eye a particular integrated contact lens device should be introduced into, which direction the temporal or nasal side of the integrated contact lens device is oriented, which side of the integrated contact lens device is the anterior side (if the lens is everted in any way, as can occur with soft contact lenses), which lid speculum portion is configured for the upper or lower eyelid, and combinations thereof.

[0044] Markings can be applied to embodiments of the one-piece contact lens device during or after its manufacture. For example, markings can be applied to the front surface of the one-piece contact lens device using dye or ink application techniques, such as electrostatic deposition onto the surface. In another example, markings can be etched or incised into the front surface of the one-piece contact lens device, such as by using an acidic solution, a mechanical material extraction device, or a laser, to create a pattern on the surface by removing material by pyrolysis. In another example, markings can be integrated into the material of the one-piece contact lens device during its manufacture. Such markings are often referred to as "mold marks" in the polymer processing industry and can be raised from the surface (the mold has complementary cavities that allow additional material to be filled) or recessed into the surface (the mold has complementary protrusions that prevent material from creeping into the mold configuration).

[0045] FIG. 3A provides a front view of a fully integrated contact lens device 3000 after being introduced into an eye, according to one or more embodiments. The integrated contact lens device 3000 appears to be configured similarly to the integrated contact lens device 2000A of FIG. 2A, i.e., a device configured for introduction into the left eye. The integrated contact lens device 3000 appears to have already been introduced into the eye 6000. Behind the lens 3100, features of the anterior portion 6100 of the eye 6000 can be seen, including the cornea 6102, iris 6104, and pupil 6106. A significant portion of the sclera 6108 is also visible due to the constraining feature of the embodiment of the integrated contact lens device 3000. The upper eyelid 6200 is partially constrained by the upper eyelid speculum portion 3200. Portions of some upper eyelid eyelashes 6202 appear to be constrained, folded, and protruding upward from the upper eyelid speculum portion 3200. The lower eyelid 6300 is also shown partially restrained by the lower speculum portion 3300, with the eyelashes 6302 folded and protruding downward.

[0046] Figure 3B provides a side cross-sectional view of the fully integrated contact lens device 3000 introduced into the eye 6000, taken along line CC of Figure 3A. As can be better appreciated from this perspective, both the upper eyelid 6200 and the lower eyelid 6300 are fully restrained within the upper and lower speculum cups 3240 and 3340, respectively. The upper posterior projection 3220 is positioned between and frictionally coupled to the upper palpebral conjunctiva 6204 and the upper bulbar conjunctiva 6206, and the lower posterior projection 3320 is positioned between and frictionally coupled to the upper palpebral conjunctiva 6304 and the upper bulbar conjunctiva 6306. The position and frictional fit should not only help to maintain the one-piece contact lens device in place over the cornea and anterior portion of the sclera, but also prevent inadvertent up and down movement of both the upper and lower eyelids.

[0047] 3B shows that there is an ocular fluid buffering layer 3402 disposed between the posterior lens surface 3130 and both the cornea 6102 and a portion of the sclera 6108. For most, if not all, lenses 3100, the ocular fluid buffering layer 3402 is contained posterior to the posterior lens surface 3130 and is held from loss by a combination of the periphery of the lens 3100 and the posterior outer surfaces of the posterior projections 3220, 3320 of both the upper and lower speculum portions 3200, 3300 of the integrated contact lens device 3000, respectively.

[0048] Without wishing to be bound by theory, it is believed that the ocular fluid buffering layer 3402 may naturally occur between the eye 6000 and the integrated contact lens device 3000 during use of the integrated contact lens device 3000. For example, the ocular fluid buffering layer 3402 may include natural fluids that accumulate from the eye 6000, such as moisture from the patient's tears. In one or more embodiments, the ocular fluid buffering layer 3402 may also include a synthetic buffering fluid. For example, the ocular fluid buffering layer 3402 may include a buffering fluid, such as a buffer solution, that is introduced by the examiner to the surface of the eye 6000 or the posterior lens surface 3130 prior to placement of the integrated contact lens device 3000. In combination with the natural fluids present, the buffering fluid may be useful as part of the ocular fluid buffering layer 3402 to protect the cornea 6102 and the portion of the sclera 6108 that resides behind the lens 3100 of the device 3000 during the examination process.

[0049] As will be further described, a buffer fluid can be introduced to either or both the surface of the eye 6000 or the posterior lens surface 3130 prior to application of the contact lens device 3000 to the surface of the eye 6000. Introducing a buffer fluid to the posterior lens surface 3130 of the one-piece contact lens device 3000 can wet the posterior lens surface 3130 in preparation for introduction onto the eye 6000. This can allow for lubrication of the posterior lens surface 3130 as well as hydration of the lens 3100 of the one-piece contact lens device 3000. Introducing a buffer fluid can allow a certain amount of accumulated buffer fluid on the posterior lens surface 3130 to be trapped within the void formed by the posterior surface 3130 and the outer surface of the cornea 6102 and a portion of the sclera 6108 when the one-piece contact lens 3000 is introduced into the eye 6000, forming an ocular fluid buffer layer 3402.

[0050] The buffer solution may comprise a slightly saline solution with a mild pH (approximately 7.0). In one or more embodiments, the buffer solution may comprise an artificial tear solution, such as, but not limited to, hydroxypropyl methylcellulose in distilled water. In one or more embodiments, the buffer solution may comprise a humectant. In one or more embodiments, the buffer solution may comprise a lubricant. In one or more embodiments, the buffer solution may comprise an anti-inflammatory agent. The anti-inflammatory agent may be specifically selected for use on the cornea 6102, the sclera 6108, or both.

[0051] 3B also shows the one-piece contact lens device 3000 with a protective anterior surface coating 3500. The illustrated protective anterior surface coating 3500 is bonded not only to the anterior surface 3120 of the lens 3100, but also to at least a portion of each of the outer surfaces of the anterior projections 3210, 3310. Bonding to both the lens 3100 and at least a portion of the anterior projections 3210, 3310 of the upper and lower eyelid speculum portions 3200, 3300 can provide a form of rigidity to the one-piece contact lens device 3000, making it easier for a physician to handle and secure it within a patient's eye 6000. The protective anterior surface coating 3500 can optionally extend entirely through the tips 3212, 3312 of the anterior projections 3210, 3310, respectively, although this is not shown for the one-piece contact lens device 3000 in FIG. 3B. In one or more embodiments, the protective front surface coating 3500 is bonded to the anterior lens surface 3120 of the integrated contact lens device 3000. In one or more embodiments, the protective front surface coating 3500 is bonded to at least a portion of the outer surface of the anterior projection 3210 of the upper eyelid speculum portion 3200 of the integrated contact lens device 3000. In one or more embodiments, the protective front surface coating 3500 is bonded to at least a portion of the outer surface of the anterior projection 3310 of the lower eyelid speculum portion 3300 of the integrated contact lens device 3000.

[0052] In one or more embodiments, the composition of the protective front coating 3500 for the one-piece contact lens device 3000 includes a material that is more rigid than the material comprising the remainder of the one-piece contact lens device. For example, the protective front coating 3500 can include a homopolymer, polymer blend, or copolymer including poly(methyl)methacrylate (PMMA). Such a material can provide the protective front coating 3500 with structural rigidity to maintain the overall shape of the one-piece contact lens device 3000, strength to inhibit inadvertent up and down movement of the eyelid, minimal fluid permeability to prevent fluid loss through the layers, and visual clarity to allow for inspection.

[0053] The protective front surface coating 3500 can be bonded or connected to the front surface of the one-piece contact lens device 3000 using techniques known to those skilled in the art of polymer processing and contact manufacturing, including, but not limited to, adhesive bonding, spray coating, injection molding, and reaction molding. In one or more embodiments, a bonding layer bonds the front surface 3120 of the lens 3100 of the one-piece contact lens device 3000 and the protective front surface coating 3500 together.

[0054] 3B also shows a constraining material 3404 present in both the upper eyelid speculum cup 3240 surrounding the upper eyelid 6200 and the lower eyelid speculum cup 3340 surrounding the lower eyelid 6300. In one or more embodiments, the constraining material 3404 is present in the upper eyelid speculum cup 3240. In one or more embodiments, the constraining material 3404 is present in the lower eyelid speculum cup 3340.

[0055] The useful purposes of the restraining material 3404 in either or both the upper and lower eyelid speculum cups 3240, 3340 are manifold. When the eyelid is introduced into the eyelid speculum cups, one or more eyelashes may become detached from the eyelid. In such cases, the restraining material 3404 can hold the detached eyelashes from moving out of the eyelid speculum cups and onto the anterior or (worse) posterior surface of the integrated contact lens device 3000 before or during the examination. The restraining material 3404 may be fluid and have sufficient viscosity to allow the restraining material 3404 to act as a lightweight, flowable adhesive between the eyelid and the eyelid speculum cups. The viscosity of the constraining material 3404 can be sufficiently high so that, with vertical eyelid movement, the corresponding speculum cup moves at least partially with the eyelid without the eyelid touching the inner surfaces of the anterior or posterior projections or the bottom of the speculum cup. The constraining material 3404 can also prevent a portion of the ocular fluid buffering layer 3402 from exiting the posterior side of the integrated contact lens device 3000 through the constricted portion of the conjunctiva, thereby functioning as a fluid barrier for the ocular fluid buffering layer described above. As described, the constraining material 3404 can include, consist essentially of, or consist of additives or agents that can help prevent disease transmission through or damage to the sclera and conjunctiva. The constraining material 3404 can also prevent natural secretions, such as tears, from the patient from flowing around the posterior projections of the speculum cup and into the ocular fluid buffering layer.

[0056] Constraining material 3404 may take the form of a fluid, such as a high viscosity fluid or "jelly," or a semi-solid material, such as a polymer gel, which is a three-dimensional, partially cross-linked polymer network that can undergo significant deformation. In one or more embodiments, the viscosity of constraining material 3404 is greater than the viscosity of a buffer solution.

[0057] In one or more embodiments, the restraining material 3404 may include an anti-inflammatory agent. In one or more embodiments, the restraining material 3404 may include an anesthetic agent. An anti-inflammatory or anesthetic agent may be utilized to prevent immediate or persistent irritation to the conjunctiva, a mucosal membrane, thereby improving patient comfort. In one or more embodiments, the restraining material 3404 may include an antibacterial agent. In one or more embodiments, the restraining material 3404 may include an antiviral agent.

[0058] FIG. 4A provides a front view of several components of a contact lens device before they are integrated into an integrated contact lens device 4000 (shown in FIG. 4B). The lens 4100 has a front surface 4120. A separate upper eyelid speculum portion 4200 is waiting to be bonded or connected to the upper portion of the lens 4100. A separate lower eyelid speculum portion 4300 is waiting to be bonded or connected to the lower portion of the lens 4100. Upon at least bonding the upper eyelid speculum portion 4200 and the lower eyelid speculum portion 4300 to the lens 4100, the integrated contact lens device 4000 is formed. In practice, the upper and lower eyelid speculum portions and the lens may be manufactured at different times or in different locations. Such components can then be assembled together into the integrated contact lens device by connecting or bonding via either or a combination of manual or automated processes.

[0059] In one or more embodiments, the upper eyelid speculum portion 4200 comprises a first material and the lens 4100 comprises a second material, and the first and second materials are different. In one or more embodiments, the upper eyelid speculum portion 4200 comprises a first material and the lower eyelid speculum portion 4300 comprises a second material, and the first and second materials are different.

[0060] Figure 4B provides a front view of an integrated contact lens device 4000 after integration of the components provided in Figure 4A. The integrated contact lens device 4000 is formed from the separate components of a lens 4100, an upper eyelid speculum portion 4200, and a lower eyelid speculum portion 4300 permanently bonded together.

[0061] Unless otherwise defined, all technical and scientific terms used have the same meaning as commonly understood by one of ordinary skill in the art to which these systems, devices, methods, processes and compositions belong.

[0062] The singular forms "a," "an," and "the" include plural referents unless the context dictates otherwise.

[0063] When used in this specification and the appended claims, the words "comprise," "has," and "include," and all grammatical variations thereof, are each intended to have an open, non-limiting meaning that does not exclude additional elements or steps.

[0064] Embodiments of the present disclosure may suitably "comprise / include," "consist of," or "consist essentially of" limited features that are disclosed, and may be practiced without limited features that are not disclosed.

[0065] "Optionally" means that the subsequently described event or circumstance may or may not occur. The statement includes cases where the event or circumstance occurs and cases where it does not occur.

[0066] When the words "approximately" or "about" are used, this term can mean that there can be a variation in value of up to ±10%, up to 5%, up to 2%, up to 1%, up to 0.5%, up to 0.1%, or up to 0.01%.

[0067] Ranges may be expressed as from about one particular value to about another particular value, inclusive. When such a range is expressed, it is understood that another embodiment is from the one particular value to the other particular value, as well as all particular values ​​and combinations thereof within that range.

[0068] When used, terms such as "first" and "second" are assigned arbitrarily and are intended merely to distinguish between two or more components of a system, device, or composition. It is understood that the terms "first" and "second" serve no other purpose, are not part of the name or description of the components, and do not necessarily define the relative location or position of the components. Furthermore, it is understood that the mere use of the terms "first" and "second" does not require that there be any "third" component, although that possibility is contemplated within the various embodiments described.

[0069] While only a few example embodiments have been described in detail, those skilled in the art will readily appreciate that many modifications are possible in the example embodiments without substantially departing from the scope of the disclosure as described. Accordingly, all such modifications are intended to be within the scope of the present disclosure, as defined by the following claims. In the claims, means-plus-function clauses are intended to encompass not only the structure described as performing the recited function, and structural equivalents, but also equivalent structures. For example, in the context of fastening wooden parts, nails and screws may not be structurally equivalent in that nails use cylindrical surfaces to fasten the wooden parts together, while screws use helical surfaces, but they may be equivalent structures. It is Applicant's express intention not to invoke 35 U.S.C. § 112, paragraph 6, with respect to any limitation in the claims except where the claims expressly use the words "means for" with the relevant function.

Claims

1. 1. An integrated contact lens device comprising: a contact lens portion having a periphery, an anterior surface, and a posterior surface, the contact lens portion having a center intersected by a true horizontal axis defining upper and lower portions of the periphery; an upper eyelid speculum portion coupled to the contact lens portion along the upper portion of the periphery over an upper inner minor arc periphery, the upper eyelid speculum portion including a posterior projection that at least partially defines an upper eyelid speculum cup; a lower eyelid speculum portion coupled to the contact lens portion along the lower portion of the periphery over a lower inner minor arc periphery, the lower eyelid speculum portion including a posterior projection that at least partially defines a lower eyelid speculum cup; Equipped with the upper eyelid speculum cup is configured to receive and hold the upper eyelid in a retracted manner when the posterior projection of the upper eyelid speculum portion is positioned between portions of the upper conjunctiva; a lower eyelid speculum cup configured to receive and hold a lower eyelid in a retracted manner when the posterior projection of the lower eyelid speculum portion is positioned between portions of the lower conjunctiva;

2. 10. The integrated contact lens device of claim 1, wherein the contact lens portion, the upper eyelid speculum portion, and the lower eyelid speculum portion are fully integrated.

3. 10. The one-piece contact lens device of claim 1, wherein the diameter of the contact lens portion measured through the center ranges from about 8.00 mm (millimeters) to about 15.00 mm.

4. 10. The one-piece contact lens device of claim 1, wherein the upper speculum arc angle measured from the center ranges from about 10 degrees to about 65 degrees.

5. 10. The one-piece contact lens device of claim 1, wherein the lower speculum arc angle measured from the center ranges from about 10 degrees to about 65 degrees.

6. 10. The one-piece contact lens device of claim 1, wherein the upper eyelid speculum portion includes an upper eyelid speculum inner minor arc periphery having an arc length in the range of about 3.00 mm to about 10.00 mm.

7. 10. The one-piece contact lens device of claim 1, wherein the lower speculum portion includes a lower speculum inner minor arc periphery having an arc length in the range of about 3.00 mm to about 10.00 mm.

8. The one-piece contact lens device of claim 1 , wherein the upper speculum portion has an anterior projection height ranging from about 1.00 mm to about 3.00 mm.

9. The one-piece contact lens device of claim 1 , wherein the lower speculum portion has an anterior projection height ranging from about 1.00 mm to about 3.00 mm.

10. 10. The integrated contact lens device of claim 1, wherein the upper speculum cup has a cup depth ranging from about 0.5 mm to about 2.5 mm.

11. 10. The integrated contact lens device of claim 1, wherein the lower speculum cup has a cup depth ranging from about 0.5 mm to about 2.5 mm.

12. 10. The one-piece contact lens device of claim 1, wherein the upper speculum portion is symmetrical about a true vertical axis of the contact lens portion, the true vertical axis passing through the center.

13. 10. The one-piece contact lens device of claim 1, wherein the lower speculum portion is symmetrical about a true vertical axis of the contact lens portion, the true vertical axis passing through the center.

14. 10. The one-piece contact lens device of claim 1, wherein the upper and lower eyelid speculum portions are symmetrical with respect to one another about the true horizontal axis.

15. Methacrylic acid (MAA), methyl methacrylate (MMA), vinyl alcohol (VA), diacetone acrylamide (DA), N-carboxyl vinyl ester (NCVE), phosphorylcholine (PC), ethylene glycol (EG), N,N-dimethylacrylamide (DMAA), 2-hydroxyethyl methacrylate (HEMA), N-vinylpyrrolidone (NVP), ethylene glycol dimethacrylate (EGDMA), triethylene glycol dimethacrylate (TEGDMA), tetraethylene glycol dimethacrylate 10. The one-piece contact lens device of claim 1, comprising a polymeric material formed from the polymerization reaction of one or more monomers selected from the group consisting of dimethylsiloxydi(silylbutanol)bis(vinylcarbamate (BVC), dimethylsiloxydi(silylbutanol)bis(vinylcarbamate (BVC), dimethylsiloxydi(silylbutanol)bis(vinylcarbamate (BVC)), dimethylsiloxane (DMS), tris(hydroxymethyl)aminomethane, 3-[tris(trimethylsiloxy)silyl]propyl methacrylate (TRIS), 3-[tris(trimethylsiloxy)silyl]propyl vinylcarbamate (TRIS-VC), and dimethylsiloxydi(silylbutanol)bis(vinylcarbamate (BVC).

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