Contact lens for viewing integrated with spreader

Abstract

Aspects of the present disclosure relate to an integrated contact lens device for ophthalmoscopy and methods of use thereof. The integrated contact lens device includes a lens portion, an upper spreader portion, and a lower spreader portion. The integrated contact lens device helps to improve visualization of peripheral retinas, including upper and lower half retinas, via both manual examination and wide angle cameras that can be viewed with the contact lens. The integrated contact lens device further prevents or reduces corneal dryness and patient discomfort during examination.

Description

BACKGROUND OF THE INVENTION

[0001] During ophthalmic screening involving ophthalmoscopy or digital imaging techniques, a physician may use various lenses or tools to attempt to view the interior of a patient's eye.

[0002] Ophthalmoscopy is typically performed to examine the retina of the eye. One type of ophthalmoscopy is indirect ophthalmoscopy. Indirect ophthalmoscopy is performed using a head-mounted light source, an optical system, and a hand-held lens that collects light reflected from the back of the eye. This type of examination may take a total of 10 to 30 minutes to examine both eyes of a patient. During this time, the patient is required to avoid blinking while keeping the eye being examined wide open. Also during this examination, the eye care professional is typically physically very close to the patient being examined in order to observe the reflection of light from different hemiretinal fields, particularly the difficult-to-view superior and inferior retinas. SUMMARY OF 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 cause patient discomfort and impaired image quality; and involuntary movement of the eye and eyelids, such as caused by blinking, eye rotation, and squeezing of the periorbital muscles, which is typically an involuntary response to the discomfort caused by the long examination and the exposure of the cornea to air without moisture (natural tears or "artificial tears").

[0004] One or more embodiments of an integrated contact lens device and methods of using the same are described herein, the integrated contact lens device including a lens portion, an upper retractor portion, and a lower retractor portion.

[0005] One or more embodiments of an integrated contact lens device can improve visualization of the peripheral retina (including the superior and inferior retinas) via both manual inspection and a wide-angle camera that can utilize the contact lens for viewing. Ultra-wide field digital images are typically obstructed by the presence of the upper and lower eyelids and eyelashes in the field of view. The integrated contact lens device described herein mitigates or eliminates corneal asphericity (such as caused by radial keratotomy (RK), penetrating keratoplasty (PKP), laser in-situ keratomileusis (LASIK), limbal relaxing incisions (LRI), arcuate keratotomy (AK), keratoconus (KCN), and due to corneal lacerations), thereby improving imaging of the retina. The integrated contact lens device also prevents or reduces corneal dryness and alleviates patient discomfort. The integrated upper retractor cup and integrated lower retractor cup of the integrated contact lens device can keep the eyelids open, thereby enabling a faster and more complete peripheral retina examination due to the lack of involuntary patient movement due to discomfort. The single-use nature of the integrated contact lens device eliminates the need for disinfection and cleaning requirements for expensive medical lenses (including handheld devices). Avoiding repeated handling, cleaning, and sterilization of the optical surfaces extends their useful life. Accordingly, embodiments of the present disclosure provide an apparatus and method of use for improving ophthalmoscopic examinations (including indirect ophthalmoscopy).

[0006] This summary is not intended to represent every possible embodiment or every aspect of the subject disclosure. Rather, the above summary is intended to illustrate some of the novel aspects and features of the disclosure. The features and advantages of the subject disclosure, as well as other features and advantages, will be apparent from the following detailed description and the modes of implementation of the subject disclosure in conjunction with the accompanying drawings and the appended claims. BRIEF DESCRIPTION OF THE DRAWINGS

[0007] Figure 1A A front view of a fully integrated contact lens device configured for introduction into the human eye according to one or more embodiments is provided.

[0008] Figure 1B A cross-sectional side view of the fully integrated contact lens device introduced into the eye as viewed along line of sight AA according to one or more embodiments is provided. Figure 1A of line of sight AA

[0009] Figure 1C A partial perspective view of the retractor cup of the upper retractor portion according to frame BB according to one or more embodiments is provided. Figure 1A of frame BB

[0010] Figure 2A A front view of a fully integrated contact lens device configured for introduction into the left eye according to one or more embodiments is provided.

[0011] [[ID=e6]]Figure 2B A front view of a fully integrated contact lens device configured to be introduced into the right eye according to one or more embodiments is provided.

[0012] Figure 3A A front view of a fully integrated contact lens device after being introduced into the eye according to one or more embodiments is provided.

[0013] Figure 3B A cross-sectional side view of a fully integrated contact lens device introduced into the eye as viewed along the line of sight CC according to one or more embodiments is provided. Figure 3A of the line of sight CC

[0014] Figure 4A A front view of several components of a contact lens device before being integrated into a fully integrated contact lens device according to one or more embodiments is provided.

[0015] Figure 4B A front view of a fully integrated contact lens device after the integration of components provided in Figure 4A is provided.

[0016] Throughout both the drawings and the specification, the same reference numerals refer to the same elements. Detailed Description

[0017] In the following description, details are set forth by way of example for purposes of facilitating an understanding of the disclosed subject matter. However, it will be clear to those of ordinary skill in the art that the disclosed embodiments are exemplary and not an exhaustive listing of all possible embodiments. Accordingly, it should be understood that the reference to the described examples is not intended to limit the scope of the present disclosure. Those skilled in the art within the technical field of the present disclosure will generally be fully capable of conceiving of any changes and further modifications to the described apparatus, instrument, method, and any further applications of the principles of the present disclosure. In particular, it is fully contemplated that the features, components, or steps described for one embodiment may be combined with the features, components, or steps described for other embodiments of the present disclosure.

[0018] Figures 1A to 1C An exemplary fully integrated contact lens device configured to be introduced into a human eye and parts thereof are shown. Figure 1A A front view of a fully integrated contact lens device is provided. Figure 1B is Figure 1A A cross-sectional side view of the exemplary fully integrated contact lens device provided in Figure 1C along view line AA. Figure 1A A perspective cross-sectional view of the spreader cup of the upper spreader portion of the fully integrated contact lens device in

[0019] In the context of the present application, "fully integrated" means that the exemplary contact lens device is formed as a single piece, i.e., the entirety of the exemplary contact lens device is complete, seamless, and one piece, although "parts", "sections", or "segments" may be distinguished and identified for descriptive purposes. By definition, a "fully integrated" article is "integrated", but an integrated contact lens device may also have a first part and a second part that are combined, joined, connected, or otherwise attached to a single device using joining techniques known in the art, such as by using adhesives, welding, or fastening.

[0020] Whether fully integrated or integrated, the first and second parts of the exemplary contact lens device may include the same, similar, or different materials in the various parts, sections, or segments of the contact lens device, such as the lens and the flipper parts.

[0021] Figures 1A to 1B The fully integrated contact lens device 1000 shown includes a lens 1100, an upper flipper part 1200, and a lower flipper part 1300. Figure 1C A cross-section of the lens 1100 and the upper flipper part 1200 is shown.

[0022] Upon observation Figure 1A several axes and angular lines are shown to assist in defining portions of the potential geometry of the fully integrated contact lens device 1000. The true vertical axis 5000 and the true horizontal axis 5100 are shown as intersecting at the lens center 1102 of the lens 1100. A first upper flipper angle line 5500 and a second upper flipper angle line 5501 originating from the lens center 1102 are shown as being aligned with opposite ends of the upper flipper part 1200, respectively. Moreover, a first lower flipper angle line 5600 and a second lower flipper angle line 5601 are similarly aligned with opposite ends of the lower flipper part 1300, respectively.

[0023] The true horizontal axis 5100 creates two semi-circles of the lens: an upper portion and a lower portion. The true vertical axis 5000 also creates two semi-circles of the lens: a left portion and a right portion. Using the true vertical axis 5000 and the respective angular lines, several geometric angles between the respective angular lines themselves and relative to the true vertical line can be useful for defining some of the relative dimensions of the flipper parts. The upper flipper arc angle 1234 (short dashed arc) is determined between the first upper flipper angle line 5500 and the second upper flipper angle line 5501. The lower flipper arc angle 1334 (short dashed arc) is determined between the first lower flipper angle line 5600 and the second lower flipper angle line 5601.

[0024] Using the same angular lines, the small arc circumferences of the upper spreader part 1200 and the lower spreader part 1300 can be defined. Along the lens circumference 1106 (the circumference of the lens 1100), the first upper spreader angular line 5500 and the second upper spreader angular line 5501 can be used to determine the inner small arc circumference 1238 (dashed arc) of the upper spreader part 1200; the first lower spreader angular line 5600 and the second lower spreader angular line 5601 can also be used to determine the inner small arc circumference 1338 of the lower spreader part 1300. In a similar manner, the first upper spreader angular line 5500 and the second upper spreader angular line 5501 can be used to determine the outer small arc circumference 1239 (dashed arc) along the leading tip 1212 of the front fork teeth 1210 of the upper spreader part 1200; the first lower spreader angular line 5600 and the second lower spreader angular line 5601 can be used to determine the outer small arc circumference 1339 along the leading end 1312 of the front fork teeth 1310 of the lower spreader part 1300.

[0025] The upper spreader arc angle 1234 and the lower spreader arc angle 1334 can be used together with the true vertical axis 5000 to assist in describing the relative positions of the upper spreader part 1200 and the lower spreader part 1300 along the lens circumference 1106. The first upper spreader sub-arc angle 1235 is determined between the true vertical axis 5000 and the first upper spreader angular line 5500; the second upper spreader sub-arc angle 1236 is determined between the second upper spreader angular line 5501 and the true vertical axis 5000. The sum of the two sub-arc angles 1235, 1236 is equivalent to the upper spreader arc angle 1234. The first lower spreader sub-arc angle 1335 can be determined between the true vertical axis 5000 and the first lower spreader angular line 5600; the second lower spreader sub-arc angle 1336 is determined between the second upper spreader angular line 5601 and the true vertical axis 5000. The sum of the two sub-arc angles 1335, 1336 is equivalent to the lower spreader arc angle 1334.

[0026] Continue to refer to Figure 1A, a number of radial lines extend from the lens center 1102. The lens radius 1104 reaches the lens circumference 1106, thereby indicating that the maximum boundary of the lens 1100 is located at the transition point 1110 (dashed curve) with the spreader portion or at the circumferential edge 1108 of the lens 1100. An upper spreader end radius 1232 also extends from the lens center 1102, and this upper spreader end radius reaches the leading end 1212 of the front fork tooth 1210 of the upper spreader portion 1200. The difference between the upper spreader end radius 1232 and the lens radius 1104 is the height 1230 by which the upper spreader portion 1200 extends away from the transition point 1110 of the lens circumference 1106. The lower spreader end radius 1332 reaches the leading end 1312 of the front fork tooth 1310 of the lower spreader portion 1300. The difference between the lower spreader end radius 1332 and the lens radius 1104 is the height 1330 of the lower spreader portion 1300.

[0027] In Figure 1B , a number of additional axes and angular lines can assist in defining the useful properties of the fully integrated contact lens device 1000. At the lens center 1102 in Figure 1B , the true central axis 5200 traverses the lens 1100. Figure 1B The true vertical axis 5000 and the true central axis 5200 in <00,00085>cross each other at the center 5402 of the lens front surface circle 5400 and the center 5302 of the lens back surface circle 5300. Both the upper spreader transition line 5700 and the lower spreader transition line 5701 extend from the centers 5302, 5402 through the fully integrated contact lens device 1000. The lens arc angle 5705 is determined between the upper spreader transition line 5700 and the lower spreader transition line 5701.

[0028] For Figure 1B , the lens back surface circle 5300 and the lens front surface circle 5400 are shown coaxially. The lens back surface circle 5300 has a center 5302, a radius 5304, and a circumference 5306 for describing at least a part of the back surface curvature 1136. The lens front surface circle 5400 has a center 5402, a radius 5404, and a circumference 5406 for describing at least a part of the front surface curvature 1126. In one or more embodiments, the centers of the front surface circle and the back surface circle are in the same position. In this configuration, the lens front surface circle 5400 and the lens back surface circle 5300 are coaxial, and the resulting lens thickness will be uniform. In one or more embodiments, the center 5402 of the lens front surface circle 5400 and the center 5302 of the lens back surface circle 5300 are not in the same position. In this configuration, the thickness of the lens 1100 will be different between the center of the lens 1100 and the transition point with the spreader portion.

[0029] Figure 1B and Figure 1C shows points that may be useful for differentiating the respective thickness values on a portion of the lens 1100. Figure 1B shows the center thickness 1140 and the spreader transition point thickness 1144 of the lens 1100. Figure 1C shows the circumferential edge thickness 1142 of the lens 1100.

[0030] Figure 1B and Figure 1C also shows the configurational aspects of the upper spreader portion 1200 and the lower spreader portion 1300, respectively. The upper front fork teeth 1210 and the lower front fork teeth 1310 have upper front pilot tips 1212 and lower front pilot tips 1312, and the upper front pilot tip and the lower front pilot tip have upper front fork tooth tip thicknesses 1214 and lower front fork tooth tip thicknesses 1314, respectively. The upper rear fork teeth 1220 and the lower rear fork teeth 1320 have upper rear pilot tips 1222 and lower rear pilot tips 1322, and the upper rear pilot tip and the lower rear pilot tip have upper rear fork tooth tip thicknesses 1224 and lower rear fork tooth tip thicknesses 1324, respectively. Mouths 1226, 1326 are defined between each front pilot tip 1212, 1312 and each corresponding rear pilot tip 1222, 1322, and each mouth 1226, 1326 has a mouth width 1228, 1328, respectively.

[0031] The upper spreader cup 1240 and the lower spreader cup 1340 are defined by the inner surfaces 1242, 1342 of the front fork teeth 1210, 1310 and the rear fork teeth 1220, 1320, respectively. Bottoms 1244, 1344 are defined at the intersections of the inner surfaces 1242, 1342 of the front fork teeth 1210, 1310 and the rear fork teeth 1220, 1320 of the upper spreader cup 1240 and the lower spreader cup 1340. The depths 1246, 1346 of the spreader cups 1240, 1340 are determined to be measured from the spreader cup bottoms 1244, 1344 to the associated spreader cup mouths 1226, 1326.

[0032] In some embodiments, the radius of the lens 1100 of the exemplary integrated contact lens device 1000 is greater than the radius of the human cornea into which the integrated contact lens device is introduced. Those of ordinary skill in the art understand that: the human cornea is generally not circular outside the eye; rather, it is elliptical, with a horizontal major axis diameter (typically about 11.75 millimeters (mm)) greater than the vertical minor axis diameter (typically about 11.0 mm). Moreover, some people suffer from conditions known as megalocornea or microcornea. In one or more embodiments, the diameter of the lens portion of the integrated contact lens device may be in the range of about 8.00 mm to about 15.00 mm, such as about 8.25 mm, 8.50 mm, 8.75 mm, 9.00 mm, 9.25 mm, 9.50 mm, 9.75 mm, 10.00 mm, 10.25 mm, 10.50 mm, 10.75 mm, 11.00 mm, 11.25 mm, and 11.50 mm to about 11.75 mm, 12.00 mm, 12.25 mm, 12.50 mm, 12.75 mm, 13.00 mm, 13.25 mm, 13.50 mm, 13.75 mm, 14.00 mm, 14.25 mm, 14.50 mm, 14.75 mm, and 15.00 mm (including the end values and encompassing all such values therebetween). Such a diameter range can ensure coverage of most abnormal corneal conditions.

[0033] In one or more embodiments, when the integrated contact lens device 1000 is introduced onto the eye surface, most of the lens circumference 1106 is positioned along the sclera. In one or more embodiments, when the integrated contact lens device 1000 is introduced onto the eye surface, 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 integrated contact lens 1000, but also allows a portion of the outer surfaces of the circumferential edge 1108, the transition point 1110, and the posterior fork teeth 1220, 1320 of the lower spreader portion 1200 and the upper spreader portion 1300 of the lens 1100 to contact or be in fluid communication with the surface of the sclera rather than with the cornea.

[0034] Although in Figure 1A and similar figures, the lens 1100 is shown as being generally circular when viewed from the front to the back, and the lens 1100 is generally described in geometric terms related to a circle. This is only for ease of description. Those of ordinary skill in the art should understand that in other configurations not shown in pictures, when viewed toward the front surface of the lens, the exemplary integrated contact lens device may include non-circular lenses, such as elliptical, square, rectangular, or non-geometric shapes.

[0035] Return Figure 1A, the upper spreader arc angle 1234, measured from the center 1102 of the lens 1100, defines the relative circumferential length of the upper inner minor arc circumference 1238. Similarly, the lower spreader arc angle 1334 defines the relative circumferential length of the lower inner minor arc circumference 1338. In one or more embodiments, the upper spreader arc angle 1234 may be in the range of from about 10 degrees to about 65 degrees, such as in the range of from about 10 degrees, 15 degrees, 20 degrees, 25 degrees, 30 degrees, and 35 degrees to about 40 degrees, 45 degrees, 50 degrees, 55 degrees, 60 degrees, and 65 degrees (including the end values and encompassing all such values therebetween). In one or more embodiments, the lower spreader arc angle 1334 may be in the range of from about 10 degrees to about 65 degrees, such as in the range of from about 10 degrees, 15 degrees, 20 degrees, 25 degrees, 30 degrees, and 35 degrees to about 40 degrees, 45 degrees, 50 degrees, 55 degrees, 60 degrees, and 65 degrees (including the end values and encompassing all such values therebetween). In one or more embodiments, the upper spreader arc angle 1234 and the lower spreader arc angle 1334 are substantially the same.

[0036] In Figure 1AIn [the figure], the upper spreader portion 1200 has an inner minor arc circumference 1238 of the upper spreader, where it is fully integrated with the lens 1100 at the lens circumference 1106. Similarly, the lower spreader portion 1300 has an inner minor arc circumference 1338 of the lower spreader. In one or more embodiments, the integrated contact lens device 1000 may have an inner minor arc circumference of the upper spreader that is in the range of about 3.00 mm to about 10.00 mm, such as about 3.00 mm, 3.25 mm, 3.50 mm, 3.75 mm, 4.00 mm, 4.25 mm, 4.50 mm, 4.75 mm, 5.00 mm, 5.25 mm, 5.50 mm, 5.75 mm, 6.00 mm, and 6.25 mm to about 6.50 mm, 6.75 mm, 7.00 mm, 7.25 mm, 7.50 mm, 7.75 mm, 8.00 mm, 8.25 mm, 8.50 mm, 8.75 mm, 9.00 mm, 9.25 mm, 9.50 mm, 9.75 mm, and 10.00 mm (including the end values and covering all such values therebetween). In one or more embodiments, the integrated contact lens device 1000 may have an inner minor arc circumference of the lower spreader that is in the range of about 3.00 mm to about 10.00 mm, such as about 3.00 mm, 3.25 mm, 3.50 mm, 3.75 mm, 4.00 mm, 4.25 mm, 4.50 mm, 4.75 mm, 5.00 mm, 5.25 mm, 5.50 mm, 5.75 mm, 6.00 mm, and 6.25 mm to about 6.50 mm, 6.75 mm, 7.00 mm, 7.25 mm, 7.50 mm, 7.75 mm, 8.00 mm, 8.25 mm, 8.50 mm, 8.75 mm, 9.00 mm, 9.25 mm, 9.50 mm, 9.75 mm, and 10.00 mm (including the end values and covering all such values therebetween). In one or more embodiments, the upper inner minor arc circumference 1238 and the lower inner minor arc circumference 1338 are substantially the same.

[0037] The position of the upper spreader portion 1200 along the lens circumference 1106 can be described relative to a number of axes (such as the true vertical axis 5000). In Figure 1AAn exemplary contact lens device 1000 is shown, which has an upper spreader portion 1200 having a bifurcated upper spreader arc angle 1234, namely: a first upper spreader sub-arc angle 1235 and a second upper spreader sub-arc angle 1236, which have substantially the same value. In one or more embodiments, the upper spreader portion 1200 is positioned such that it is centered relative to the true vertical axis in the upper semi-circle of the lens 1100. Similarly, in one or more embodiments, the lower spreader portion 1300 is positioned such that it is centered relative to the true vertical axis in the lower semi-circle of the lens 1100. In one or more embodiments, both the upper spreader portion 1200 and the lower spreader portion 1300 are positioned such that they are each centered relative to the true vertical axis 5000 in opposite semi-circles of the lens 1100.

[0038] As previously described, the spreader tines have an outer length measured from the transition point of the lens 1100 and the spreader portion along the circumference of the lens (for both the upper spreader portion 1200 and the lower spreader portion 1300). In Figure 1B , the upper spreader portion 1200 has a height 1230 measured along the front tine 1210; the lower spreader portion 1300 has a height 1330 measured along the front tine 1310. In one or more embodiments, the height of the upper spreader portion 1200 of the exemplary integrated contact lens device is in the range of about 1 mm to about 3 mm, such as in the range of about 1.00 mm, 1.25 mm, 1.50 mm, and 1.75 mm to about 2.00 mm, 2.25 mm, 2.50 mm, 2.75 mm, and 3.00 mm (including the end values and covering all such values therebetween). In one or more embodiments, the height of the lower spreader of the exemplary integrated contact lens device is in the range of about 1 mm to about 3 mm, such as in the range of about 1.00 mm, 1.25 mm, 1.50 mm, and 1.75 mm to about 2.00 mm, 2.25 mm, 2.50 mm, 2.75 mm, and 3.00 mm (including the end values and covering all such values therebetween). In one or more embodiments, the heights of the upper spreader and the lower spreader are substantially the same.

[0039] The spreader cups 1240, 1340 have cup depths 1246, 1346 respectively, which are measured from the bottoms 1244, 1344 of the cups 1240, 1340 (where the corresponding front tines and rear tines meet along the inner surface of the spreader cup) to the mouths of the spreader cups, which are defined as the entry points of the spreader cups and are between the tips of the front tines and the tips of the rear tines (for both the upper spreader portion 1200 and the lower spreader portion 1300). In Figure 1BIn [the figure], the upper eyelid retractor portion 1200 has a retractor cup depth 1246 measured from the bottom 1244 of the upper retractor cup to the associated retractor cup opening 1226; the lower retractor portion 1300 has a retractor cup depth 1346 measured from the bottom 1344 of the lower retractor cup to the associated retractor cup opening 1326. In one or more embodiments, the cup depth 1246 of the upper retractor portion 1200 of the integrated contact lens device 1000 is in the range of about 0.5 mm to about 2.5 mm, such as in the range of about 0.50 mm, 0.75 mm, 1.00 mm, and 1.25 mm to about 1.50 mm, 1.75 mm, 2.00 mm, 2.25 mm, and 2.50 mm (including the end values and encompassing all such values therebetween). In one or more embodiments, the cup depth 1346 of the lower retractor portion 1300 of the integrated contact lens device 1000 is in the range of about 0.5 mm to about 2.5 mm, such as in the range of about 0.50 mm, 0.75 mm, 1.00 mm, and 1.25 mm to about 1.50 mm, 1.75 mm, 2.00 mm, 2.25 mm, and 2.50 mm (including the end values and encompassing all such values therebetween). In one or more embodiments, the cup depth 1246 of the upper retractor portion 1200 and the cup depth 1346 of the lower retractor portion 1300 are substantially the same. The depth of each retractor cup should be sufficient to restrain at least a portion of the patient's eyelid. Moreover, the depth of each retractor cup should be suitable for holding any eyelashes that may become dislodged during the procedure.

[0040] To simplify use and ease of manufacture, one or more exemplary contact lens devices 1000 may be configured to have one or more relative symmetries, such as Figure 1A shown. In one or more embodiments, the upper retractor portion 1200 has symmetry with respect to the true vertical axis 5000 of the contact lens device 1000. That is, along the true vertical axis 5000, the upper retractor portion 1200 is a mirror image of itself and has equivalent dimensions (e.g., minor arc circumference, height). In one or more embodiments, the lower retractor portion 1300 has symmetry with respect to the true vertical axis 5000 of the contact lens device. In one or more embodiments, the upper retractor portion 1200 and the lower retractor portion 1300 have symmetry with respect to the true horizontal axis 5100 of the contact lens device 1000. That is, the upper retractor portion 1200 and the lower retractor portion 1300 are mirror images of each other along the true horizontal axis 5100.

[0041] The materials for the integrated contact lens device 1000 can include homopolymers, polymer blends, or copolymers made by the reaction of one or more monomers. A homopolymer is a polymer that contains only the reaction product of one monomer. A copolymer is a polymer that contains the reaction product of two or more monomers. In some cases, a copolymer can be the product of the co-reaction of two polymers (such as two different homopolymers), for example, in a block, graft, or cross-linked (using a cross-linking agent) configuration. A polymer blend is a physical blend of two or more polymers, such as by melt extrusion or mixing; the blend does not necessarily require a reaction between the two or more polymers.

[0042] Useful monomers for making one or more polymers for the integrated contact lens device can include, but are not limited to, methacrylic acid (MAA), methyl methacrylate (MMA), vinyl alcohol (VA), diacetone acrylamide (DA), N-carboxyvinyl 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 (TTEGMDA), dimethyl siloxane (DMS), tris(hydroxymethyl)aminomethane, 3-[tris(trimethylsiloxy)silyl]propyl methacrylate (TRIS), 3-[tris(trimethylsiloxy)silyl]propyl vinyl carbamate (TRIS-VC), and dimethylsiloxydio(busilanol) bis(vinyl carbamate) (BVC).

[0043] Figure 2A A front view of an exemplary fully integrated contact lens device 2000A configured to be introduced into the left eye is provided. Figure 2B A front view of another exemplary fully integrated contact lens device 2000B configured to be introduced into the right eye is provided. Figure 2A and Figure 2B and the integrated contact lens devices 2000A and 2000B can respectively look similar to Figure 1A and the integrated contact lens device 1000; however, there are important configurational differences in both the orientation of the upper spreader portion and the orientation of the lower spreader portion, which in some cases can make them more suitable for use in the patient's left and right eyes respectively.

[0044] Similar to the way the upper spreader arc angle 1234 and the lower spreader arc angle 1334 of the integrated contact lens device 1000 respectively define the circumferential lengths of the upper inner minor arc circumference 1238 and the lower inner minor arc circumference 1338, in Figure 2AIn [text not provided], the upper spreader arc angle 2234A and the lower spreader arc angle 2334A of the integrated contact lens device 2000A respectively define the circumferential lengths of the upper inner minor arc circumference 2238A and the lower inner minor arc circumference 2338A. In Figure 2B In [text not provided], the upper spreader arc angle 2234B and the lower spreader arc angle 2334B of the integrated contact lens device 2000B respectively define the circumferential lengths of the upper inner minor arc circumference 2238B and the lower inner minor arc circumference 2338B. In one or more embodiments, the upper spreader arc angle and the lower spreader arc angle of the integrated contact lens device 2000A and / or 2000B are not substantially the same. In one or more embodiments, the upper inner minor arc circumference and the lower inner minor arc circumference of the integrated contact lens device 2000A and / or 2000B are not substantially the same.

[0045] As previously utilized, the upper spreader portion can be described along the lens circumference relative to several axes (such as the upper portion of the true vertical axis 5000). In Figure 2A An exemplary contact lens device 2000A is shown in [text not provided], which has a bifurcated upper spreader arc angle 2234A, that is, the upper spreader arc angle 2234A is divided into a first upper spreader sub-arc angle 2235A and a second upper spreader sub-arc angle 2236A; however, in this case, since the upper spreader portion 2200A is not centered relative to the true vertical axis 5000, the first upper spreader sub-arc angle 2235A and the second upper spreader sub-arc angle 2236A do not have substantially similar values after bifurcation. In fact, those of ordinary skill in the art may note that the upper spreader portion 2200A is shifted towards the stage right of the device 2000A. Therefore, the second upper spreader sub-arc angle 2236A has a larger value than the first upper spreader sub-arc angle 2235A. In one or more embodiments, the upper spreader portion 2200A is positioned such that it is not centered relative to the true vertical axis 5000 in the upper semi-circle of the lens 2100A. Figure 2B Similarly shown for the contact lens device 2000B, the first upper spreader sub-arc angle 2235A is greater than the second upper spreader sub-arc angle 2236A because the upper spreader portion 2200B is shifted towards the stage left of the device 2000B.

[0046] In Figure 2A and Figure 2B In [text not provided], those of ordinary skill in the art can also observe that: in one or more embodiments, the lower spreader portion 2300A or 2300B is respectively positioned such that it is not centered relative to the true vertical axis 5000 in the lower semi-circle of the lens 2100A or 2100B. In Figure 2AAn exemplary contact lens device 2000A is shown, which has a bifurcated lower spreader arc angle 2334, that is, the lower spreader arc angle 2334 is divided into a first lower spreader sub-arc angle 2335A and a second lower spreader sub-arc angle 2336A; however, in this case, since the lower spreader part 2200A is not centered with respect to the true vertical axis 5000, the first lower spreader sub-arc angle 2335A and the second upper spreader sub-arc angle 2336A do not have approximately similar values after bifurcation. In fact, one of ordinary skill in the art can note that the lower spreader part 2300A is shifted towards the right side of the platform of the device 2000A. Accordingly, the second upper spreader sub-arc angle 2336A has a greater value than the first upper spreader sub-arc angle 2335A. In one or more embodiments, the lower spreader part 2300A is positioned such that it is not centered with respect to the true vertical axis 5000 in the lower half of the lens 2100A. Figure 2B Similarly shown for the embodiment contact lens device 2000B, the first lower spreader sub-arc angle 2335A is greater than the second upper spreader sub-arc angle 2336A because the upper spreader part 2300B is shifted towards the left side of the platform of the device 2000B.

[0047] For the integrated contact lens devices 2000A, 2000B, there is an apparent lack of symmetry, which can generally be useful for a particular eye shape, or for customizing the integrated contact lens device specifically for a certain patient. In one or more embodiments, the upper spreader part 2200A or 2200B does not have symmetry with respect to the true vertical axis 5000 of the contact lens device. In one or more embodiments, the lower spreader part 2300A or 2300B does not have symmetry with respect to the true vertical axis 5000 of the contact lens device. In one or more embodiments, the upper spreader part 2200A or 2200B and the lower spreader part 2300A or 2300B do not have symmetry with respect to the true horizontal axis 5100 of the contact lens device. That is, the upper spreader part 2200A or 2200B and the lower spreader part 2300A or 2300B are not mirror images of each other along the true vertical axis 5000. This can in turn reflect the different configurations of the upper and lower eyelids.

[0048] Despite the possible lack of symmetry, the left-eye and right-eye configurations of the embodiment integrated contact lens devices do have certain angular relationships that can be characterized. This can be clearly seen in Figure 2A and Figure 2B where both the upper spreader part and the lower spreader part are clearly shifted towards the right side of the platform (in the case of Figure 2A ), and clearly shifted towards the left side of the platform (in the case of Figure 2B(in the case of). In one or more embodiments, the first upper expander sub-arc angle of the integrated contact lens device is greater than the second upper expander sub-arc angle and the first lower expander sub-arc angle is greater than the second lower expander sub-arc angle. This configuration describes Figure 2B the right contact lens of the integrated contact lens device 2000B of the embodiment. In one or more embodiments, the first upper expander sub-arc angle of the integrated contact lens device is less than the second upper expander sub-arc angle and the first lower expander sub-arc angle is less than the second lower expander sub-arc angle. This configuration describes Figure 2A the left contact lens of the integrated contact lens device 2000A of the embodiment.

[0049] Both of these integrated contact lens devices 2000A and 2000B show markers or labels on the upper expander part and / or the lower expander part, which were not shown in other figures previously but can be envisioned. [[ID=ed]]Figure 2A It shows that the integrated contact lens device 2000A has the text 2250A and the letter 2251A at opposite ends of the upper expander part 2200A; it also has the text 2350A and 2350B in a similar manner on the lower expander part 2300A. What a general practitioner in the art can observe is that for the integrated contact lens device with a left-eye orientation, the letter "N" faces the left side of the platform of the viewer, while the letter "T" faces the right side of the platform. Thus, a general practitioner in the art can speculate that in this case, the letter "N" may represent the term "nasal", and the letter "T" may represent the term "temporal".

[0050] Figure 2B It shows that the integrated contact lens device 2000B has the text 2250B ("U") on the upper expander part 2200B; at the same time, it has the text 2350B ("L") on the lower expander part 2300B, and this text is combined with the text 2250B. A general practitioner in the art can then speculate that these letters mean the "upper" expander cup and the "lower" expander cup. On both the upper expander part 2200B and the lower expander part 2300B, there are also arrows 2252B, 2352B (→), which, from the perspective of the physician, point outwards and to the left side of the platform. Combined with the text, a general practitioner in the art can then speculate that these arrows point to the temporal side of the eye. Given that the markings and text are present on the front side of the integrated contact lens device, this device is configured for use in the right eye of a patient.

[0051] Such markers can help the physician identify which eye the specific integrated contact lens device should be introduced into, which direction the temporal or nasal side of the integrated contact lens device points to, which side of the integrated contact lens device is the front side (if the lens is inverted in some way, as may happen with soft contact lenses), which expander part is configured for the upper eyelid or the lower eyelid, and combinations thereof.

[0052] The marker can be applied to the exemplary integrated contact lens device during or after its manufacture. For example, the marker can be applied to the front surface of the integrated contact lens device by using a dye or ink application technique (such as electrostatic layering) on the surface. In another example, the marker can be etched or engraved into the front surface of the integrated contact lens device, such as by using an acidic solution, a mechanical material extraction device, or a laser, to create a pattern in the surface by removing material through thermal degradation. In another example, the marker can be integrated into the material of the integrated contact lens device during the manufacture of the integrated contact lens device. Such markers are commonly 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 fill the cavities) or recessed into the surface (the mold has complementary protrusions so that no material fills the mold when it is formed).

[0053] Figure 3A A front view of a fully integrated contact lens device 3000 after being introduced into the eye is provided according to one or more embodiments. The configuration of the integrated contact lens device 3000 looks similar to Figure 2A the integrated contact lens device 2000A, i.e., as a device configured to be introduced into the left eye. The integrated contact lens device 3000 is considered to have been previously introduced into the eye 6000. The features of the anterior portion 6100 of the eye 6000 can be seen behind the lens 3100, including the cornea 6102, the iris 6104, and the pupil 6106. Due to the constrained features of the exemplary integrated contact lens device 3000, most of the sclera 6108 is also visible. The upper eyelid 6200 is partially constrained by the upper spreader portion 3200. Some portions of the several upper eyelid lashes 6202 are seen to be constrained and protruding upward from the upper spreader portion 3200 and have been flipped. The lower eyelid 6300 is also shown to be partially constrained by the lower spreader portion 3300 and has flipped, downward-protruding lashes 6302.

[0054] Figure 3B A view is provided along Figure 3ACross-sectional side view of the fully integrated contact lens device 3000 in the eye 6000 as observed by the line of sight CC. As better understood from this advantageous angle, both the upper eyelid 6200 and the lower eyelid 6300 are fully constrained within the upper retractor cup 3240 and the lower retractor cup 3340, respectively. The upper posterior prong 3220 is positioned between the upper eyelid conjunctiva 6204 and the superior bulbar conjunctiva 6206 and is frictionally coupled to both the upper eyelid conjunctiva and the superior bulbar conjunctiva; the lower posterior prong 3320 is positioned between the lower eyelid conjunctiva 6304 and the inferior bulbar conjunctiva 6306 and is frictionally coupled to both the lower eyelid conjunctiva and the inferior bulbar conjunctiva. The position and frictional coupling should not only help to maintain the integrated contact lens device in its position on the anterior portion of the cornea and sclera, but also constrain the inadvertent vertical movement of both the upper eyelid and the lower eyelid.

[0055] In Figure 3B An ocular fluid buffer layer 3402 is shown disposed between the posterior surface 3130 of the lens and the cornea 6102 and a portion of the sclera 6108. The ocular fluid buffer layer 3402 is contained behind the posterior surface 3130 of the lens for most, if not all, of the lens 3100 and is retained from loss by the combination of the circumferential edge of the lens 3100 of the integrated contact lens device 3000 with the outer posterior surfaces of the respective posterior prongs 3220, 3320 of both the upper retractor portion 3200 and the lower retractor portion 3300.

[0056] Although not wishing to be bound by theory, it is believed that the ocular fluid buffer layer 3402 can form naturally between the eye 6000 and the integrated contact lens device during use of the integrated contact lens device 3000. For example, the ocular fluid buffer layer 3402 can include natural fluids accumulated from the eye 6000, such as moisture from tears secreted by the patient. In one or more embodiments, the ocular fluid buffer layer 3402 can also include a synthetic buffer fluid. For example, the ocular fluid buffer layer 3402 can include a buffer fluid introduced by an examiner onto the surface of the eye 6000 or the posterior surface 3130 of the lens prior to placement of the integrated contact lens device 3000, such as a buffer solution. In combination with the natural fluids present, the buffer fluid can serve as part of the ocular fluid buffer layer 3402 during the examination process to protect the portion of the sclera 6108 and the cornea 6102 that are present behind the lens 3100 of the device 3000.

[0057] As will be further described, prior to applying the contact lens device 3000 to the surface of the eye 6000, a buffer fluid can be introduced into either or both of the surface of the eye 6000 and the posterior lens surface 3130. Introducing the buffer fluid into the posterior lens surface 3130 of the integrated contact lens device 3000 allows the posterior lens surface 3130 to be wetted in preparation for introduction onto the eye 6000. This can allow lubrication of the posterior lens surface 3130 and allow hydration of the lens 3100 of the integrated contact lens device 3000. Introducing the buffer fluid can also allow the amount of buffer fluid accumulating on the posterior lens surface 3130 when the integrated contact lens 3000 is introduced into the eye 6000 to be trapped in the void formed by the posterior surface 3130 and the outer surfaces of the cornea 6102 and the partial sclera 6108, thereby forming an ocular fluid buffer layer 3402.

[0058] The buffer solution can comprise a micro-salt solution at a mild pH (about 7.0). In one or more embodiments, the buffer solution can comprise an artificial tear solution such as, but not limited to, hydroxypropyl methylcellulose in distilled water. In one or more embodiments, the buffer solution can comprise a wetting agent. In one or more embodiments, the buffer solution can comprise a lubricant. In one or more embodiments, the buffer solution can comprise an anti-inflammatory agent. The anti-inflammatory agent can be specifically selected for the cornea 6102, the sclera 6108, or both.

[0059] In Figure 3B it, a protective front surface coating 3500 is also shown to be present in the integrated contact lens device 3000. The shown protective front surface coating 3500 is coupled not only to the front surface 3120 of the lens 3100 but also to at least a portion of the outer surface of each of the front fork teeth 3210, 3310. The at least a portion of the front fork teeth 3210, 3310 that are coupled to the lens 3100 and the upper spreader portion 3200 and the lower spreader portion 3300 can provide formal rigidity to the integrated contact lens device 3000, which can make it easier for a physician to handle and fix it in the patient's eye 6000. In some cases, the protective front surface coating 3500 can extend through the tips 3212, 3312 of the front fork teeth 3210, 3310, respectively, although this is not essential for Figure 3BThe integrated contact lens device 3000 in [it] is not shown. In one or more embodiments, the protective front surface coating 3500 is coupled to the lens front surface 3120 of the integrated contact lens device 3000. In one or more embodiments, the protective front surface coating 3500 is coupled to at least a portion of the outer surface of the front fork teeth 3210 of the upper spreader portion 3200 of the integrated contact lens device 3000. In one or more embodiments, the protective front surface coating 3500 is coupled to at least a portion of the outer surface of the front fork teeth 3310 of the lower spreader portion 3300 of the integrated contact lens device 3000.

[0060] In one or more embodiments, the constituent material of the protective front surface coating 3500 of the integrated contact lens device 3000 is more rigid than the material of the rest of the integrated contact lens device. For example, the protective front surface coating 3500 may include a homopolymer, a polymer blend, or a copolymer containing poly(methyl)methacrylate (PMMA). Such materials can provide structural rigidity to the protective front surface coating 3500 to maintain: the overall shape of the integrated contact lens device 3000, the strength to restrain the inadvertent vertical movement of the eyelids, the minimum fluid permeability to prevent fluid loss through the layer, and the visual clarity to allow inspection.

[0061] The protective front surface coating 3500 can be coupled or attached to the front surface of the integrated contact lens device 3000 using techniques known to those of ordinary skill in the fields of polymer processing and contact manufacturing, including but not limited to adhesion, spraying, injection molding, and reaction molding. In one or more embodiments, an adhesive layer adheres the front surface 3120 of the lens 3100 of the integrated contact lens device 3000 and the protective front surface coating 3500 together.

[0062] Figure 3B Also shown in [it] is that there is restraint material 3404 around the upper eyelid 620 in the upper spreader cup 3240 and around the lower eyelid 630 in the lower spreader cup 3340. In one or more embodiments, the restraint material 3404 is present in the upper spreader cup 3240. In one or more embodiments, the restraint material 3404 is present in the lower spreader cup 3340.

[0063] The useful purposes of the confinement material 3404 in either or both of the upper applicator cup 3240 and the lower applicator cup 3340 are multiple. When the eyelid is introduced into the applicator cup, one or more eyelashes may become detached from the eyelid. In such a case, the confinement material 3404 can hold the detached eyelashes in place before or during the examination so that they do not fall out of the applicator cup and move onto the front surface or (in a worse case) the back surface of the integrated contact lens device 3000. The confinement material 3404 can be a fluid and have a viscosity that is sufficiently significant such that the confinement material 3404 acts as a mild fluid adhesive between the eyelid and the applicator cup. The viscosity of the confinement material 3404 can be great enough such that if the eyelid moves in the vertical direction, the corresponding applicator cup moves at least partially with the eyelid, at which time the eyelid does not contact the inner surface of the front or back tines or the bottom of the applicator cup. The confinement material 3404 can also prevent portions of the eye fluid buffer layer 3402 from flowing out the back of the integrated contact lens device 3000 through the constricted portion of the conjunctiva and thus act as a fluid barrier for the aforementioned eye fluid buffer layer. As will be described, the confinement material 3404 can include, consist essentially of, or consist of additives or agents that can help prevent the spread of disease through the sclera and conjunctiva or damage to the sclera and conjunctiva. The confinement material 3404 can also prevent natural secretions, such as tears from the patient, from bypassing the back tines of the applicator cup and entering the eye fluid buffer layer.

[0064] The confinement material 3404 can take the form of a fluid, such as a highly viscous fluid or a "gel," or a semi-solid material, such as a polymeric gel, which is a three-dimensional partially cross-linked polymer network that can undergo significant deformation. In one or more embodiments, the viscosity of the confinement material 3404 is greater than the viscosity of the buffer solution.

[0065] In one or more embodiments, the confinement material 3404 can include an anti-inflammatory agent. In one or more embodiments, the confinement material 3404 can include an anesthetic. The anti-inflammatory agent or anesthetic can be used to prevent immediate or persistent irritation to the conjunctiva, which is a mucous membrane, thereby increasing patient comfort. In one or more embodiments, the confinement material 3404 can include an antibacterial agent. In one or more embodiments, the confinement material 3404 can include an antiviral agent.

[0066] Figure 4A Provided is an integrated contact lens device 4000( Figure 4BFront view of several components of a prior contact lens device (as shown). The lens 4100 has a front surface 4120. A separate upper spreader portion 4200 awaits coupling or connection to the upper portion of the lens 4100. A separate lower spreader portion 4300 awaits coupling or connection to the lower portion of the lens 4100. When the upper spreader portion 4200 and the lower spreader portion 4300 are at least coupled to the lens 4100, an integrated contact lens device 4000 is formed. In practice, the upper and lower spreader portions and the lens may be manufactured at different times or in different locations. Then, such components can be assembled together into an integrated contact lens device through connection or coupling by either a manual process or an automated process or a combination thereof.

[0067] In one or more embodiments, the upper spreader portion 4200 comprises a first material and the lens 4100 comprises a second material, wherein the first material and the second material are different. In one or more embodiments, the upper spreader portion 4200 comprises a first material and the lower spreader portion 4300 comprises a second material, wherein the first material and the second material are different.

[0068] Figure 4B A front view of the integrated contact lens device 4000 is provided after the integration of the components provided in Figure 4A The integrated contact lens device 4000 is formed by permanently joining together separate component parts (the lens 4100, the upper spreader portion 4200, and the lower spreader portion 4300) into one piece.

[0069] Unless otherwise defined, all technical and scientific terms used herein 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.

[0070] Unless the context clearly indicates otherwise, the singular forms "a", "an", and "the" include plural referents.

[0071] As used herein and in the appended claims, the words "comprising", "having", and "including" and all their grammatical variants are each intended to have an open, non - limiting meaning that does not exclude additional elements or steps.

[0072] Embodiments of the present disclosure may suitably "comprise", "consist of", or "consist essentially of" the disclosed limiting features and may be practiced in the absence of an undisclosed limiting feature.

[0073] "Optionally" means that the subsequent described event or situation may or may not occur. The specification includes examples where the event or situation occurs and examples where the event or situation does not occur.

[0074] When the terms “about” or “approximately” are used, the term can mean that the value can vary by 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%.

[0075] Ranges can be expressed as from about one particular value to about another particular value (including the end values). When stating such a range, it should be understood that another embodiment is from a particular value to another particular value, along with all particular values within that range and their combinations.

[0076] As used, terms such as “first” and “second” are arbitrarily assigned and are only intended to distinguish two or more components of a system, device, or composition. It should be understood that the terms “first” and “second” have no other purpose and are not part of the name or description of the component, nor do they necessarily define the relative positioning or location of the component. Additionally, it should be understood that the use of only the terms “first” and “second” does not require the existence of any “third” component, but such a possibility may be envisioned within the scope of the different embodiments described.

[0077] Although only a few exemplary embodiments have been described in detail, it will be readily understood by those skilled in the art that many modifications can be made to the exemplary embodiments without materially departing from the scope of the disclosure described. Accordingly, all such modifications are intended to be included within the scope of the present disclosure as defined in the appended claims. In the claims, the means-plus-function clauses are intended to cover structures described as performing the recited function and cover not only structural equivalents but also equivalent structures. For example, although a nail and a screw may not be structural equivalents (because a nail uses a cylindrical surface to hold wooden parts together while a screw uses a helical surface), in the context of fastening wooden parts, a nail and a screw can be equivalent structures. The applicant's express intent is not to invoke 35 U.S.C. § 112, paragraph 6, for any limitation of any claim, except where the claim expressly uses the phrase “means for...” and is accompanied by the relevant function.

Claims

1. An integrated contact lens device, comprising: A contact lens portion having a circumferential edge, a front surface, and a rear surface, wherein the contact lens portion has a center that is traversed by a true horizontal axis that defines an upper portion and a lower portion of the circumferential edge; An upper expander portion that is coupled to the contact lens portion along the upper portion of the circumferential edge to form an upper inner minor arc circumference, the upper expander portion including rear prongs that at least partially define an upper expander cup; and A lower expander portion that is coupled to the contact lens portion along the lower portion of the circumferential edge to form a lower inner minor arc circumference, the lower expander portion including rear prongs that at least partially define a lower expander cup, wherein the upper expander cup is configured to receive and hold the upper eyelid in a retracted manner when the rear prongs of the upper expander portion are positioned between portions of the superior conjunctiva, and wherein the lower expander cup is configured to receive and hold the lower eyelid in a retracted manner when the rear prongs of the lower expander portion are positioned between portions of the inferior conjunctiva.

2. The integrated contact lens device according to claim 1, wherein, The contact lens portion, the upper expander portion, and the lower expander portion are fully integrated.

3. The integrated contact lens device according to claim 1, wherein The diameter of the contact lens portion measured through the center is in the range of about 8.00 mm (millimeters) to about 15.00 mm.

4. The integrated contact lens device according to claim 1, wherein, The upper expander arc angle measured from the center is in the range of about 10° (degrees) to about 65°.

5. The integrated contact lens device according to claim 1, wherein, The lower expander arc angle measured from the center is in the range of about 10° to about 65°.

6. The integrated contact lens device according to claim 1, wherein, The upper expander portion includes an upper expander inner minor arc circumference having an arc length in the range of about 3.00 mm to about 10.00 mm.

7. The integrated contact lens device according to claim 1, wherein, The lower expander portion includes a lower expander inner minor arc circumference having an arc length in the range of about 3.00 mm to about 10.00 mm.

8. The integrated contact lens device according to claim 1, wherein, The upper expander portion has a front prong height in the range of about 1.00 mm to about 3.00 mm.

9. The integrated contact lens device according to claim 1, wherein, The lower expander has a front prong height in the range of about 1.00 mm to about 3.00 mm.

10. The integrated contact lens device according to claim 1, wherein, The upper expander cup has a cup depth in the range of about 0.5 mm to about 2.5 mm.

11. The integrated contact lens device according to claim 1, wherein, The lower expander cup has a cup depth in the range of about 0.5 mm to about 2.5 mm.

12. The integrated contact lens device according to claim 1, wherein, The upper expander portion is symmetric with respect to the true vertical axis of the lens portion, wherein the true vertical axis traverses the center.

13. The integrated contact lens device according to claim 1, wherein, The lower expander portion is symmetric with respect to the true vertical axis of the lens portion, wherein the true vertical axis traverses the center.

14. The integrated contact lens device according to claim 1, wherein, The upper expander portion and the lower expander portion are symmetric with respect to each other with respect to the true horizontal axis.

15. The integrated contact lens device according to claim 1, wherein, The integrated contact lens device includes a polymer material formed by polymerization of one or more monomers selected from the group consisting of methacrylic acid (MAA), methyl methacrylate (MMA), vinyl alcohol (VA), diacetone acrylamide (DA), N-carboxyvinyl 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 (TTEGMDA), dimethylsiloxane (DMS), tris(hydroxymethyl)aminomethane, 3-[tris(trimethylsiloxy)silyl]propyl methacrylate (TRIS), 3-[tris(trimethylsiloxy)silyl]propyl vinylcarbamate (TRIS-VC), and dimethylsiloxydio(silylbutanol) bis(vinylcarbamate) (BVC).

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