Patent Description:
<CIT> relates to an annular mask lens for the treatment of optical aberrations. The lens has an annular mask having an aperture larger than conventional pinhole contact lens. The aperture having a "soft" inside edge and which mask has a gradually increasing transmissivity radially toward the outer edge of the mask.

<CIT> relates to methods for fabricating annular mask lens for vision correction having diffraction-reduction edges. The lens body having an annular mask that forms a "soft edge" by gradually decreasing the transmissivity radially from the center aperture to the annular mask area.

<CIT> relates to a cosmetic contact lens on which are defined an iris region, which is to be superposed, in use, on the iris of the user, and also a peripheral ring, which is arranged annularly around the iris region and which is to be superposed, in use, on a sclera portion of the user.

<CIT> relates to tinted contact lenses, and methods for their manufacture, that incorporate a mark to indicate that the lens is a diagnostic lens.

<CIT> relates to a contact lens comprising a centrally shaded portion whose shade is optically graded from a relatively darker center to a relatively light or transparent periphery.

<CIT> relates to a scleral ring of hydrophilic material with a circular shape, or a generally elliptical shape, also a central portion. There is also a peripheral portion disposed about said central portion colored white, whereby the exposed portion of the wearer's sclera is cosmetically treated.

<CIT> relates to a prosthesis for an eye of a wearer formed from a thin film sheet sufficient to cover a portion of the sclera of the eye. The sheet has a number of sections which create the impression that the eye is generally centered within the eye socket.

<CIT> relates to a colored contact lens in which a colored band is disposed at a boundary part between a dark part and a white part of an eye, and a density is gradually changed from the dark part to the white part of the eye such that the density of this colored band decreases from the inner circumference side to an outer circumference side.

The invention is defined by a contact lens, a manufacturing method of a contact lens and a method of enhancing the appearance of a wearer's eyes by providing a contact lens according to the appended claims.

The invention provides a contact lens with a central portion and a peripheral portion disposed about the central portion. The peripheral portion is colored with a bright color and with a pattern that graduates to transparent towards the outer diameter of the lens.

The brightly colored peripheral portion can be opaque, semi-opaque, or translucent near the inner diameter of the peripheral portion and includes the pattern of a limbus or limbal ring which can be colored. The bright portion extends from the edge of the limbus into the peripheral portion creating the impression of a brighter or whiter sclera. The addition of the limbal ring provides additional contrast and assists in the overall effect of a brighter or whiter sclera. The peripheral portion of a contact lens is colored according to a geometric pattern.

The lenses of invention have a natural appearance.

The lenses of the invention have a pattern that enhances the appearance of the lens wearer's sclera. They include a limbal ring pattern that can result in the iris appearing larger or darker or more defined than it would otherwise. Additionally, the lenses of the invention can have additional pattern elements that completely or partially overlie the wearer's iris.

A "limbal ring" is an annular band of color that, when the lens is on-eye and centered, partially or completely overlies the lens wearer's limbal region, or the junction of the sclera with the cornea. The innermost border, or edge closest to the geometric center of the lens, of the limbal ring may form a circle having a diameter of about <NUM> to about <NUM>, preferably about <NUM> to about <NUM>, the circle being centered at the lens' geometric center. The ring may be of any suitable width and preferably is about <NUM> to about <NUM> in width, more preferably about <NUM> to about <NUM> in width.

The central portion contains an area that is meant to cover the iris during wear. The central portion is colored and contains a limbal ring. Preferably both the iris and the limbal ring are patterned as in <CIT>. Such coloring optionally includes substantially triangularshaped structures that resemble spokes in a wheel extending inwardly from the innermost border of the limbal ring toward the geometric center of the lens. The tapered spokes may, but preferably do not, extend over the entire iris portion of the lens, meaning the portion of the lens that overlies the iris when the lens is on-eye and centered. Rather, preferably the spokes extend inwardly from the innermost edge of the limbal ring so that the innermost edge of the spoke pattern is located at about <NUM> or more, more preferably about <NUM> or more from the geometric center of the lens. The spokes may be of uniform or varying shapes and sizes and preferably are about <NUM> to about <NUM> in length.

The lens shown in <FIG> is typically circular but can be any convenient shape for a contact lens such as an elliptical or truncated circular shape. The lens has a center, <NUM>, and a central portion <NUM>. Disposed about the central portion <NUM> and extending to the surrounding edge of the lens is a peripheral portion <NUM>. The peripheral portion has an inner diameter <NUM> and an outer diameter <NUM> which can, but need not necessarily coincide with the outer edge of the lens as a whole.

The peripheral portion <NUM> is colored with a bright color, however <FIG> does not describe the bright coloring being in the form of a geometric pattern according to the claims. "Bright colors" are defined as white, near white, off white, light yellow, pale blue, light pink, light green or any combination of the above. The bright colors are disposed so as to blend gradually with the wearer's sclera.

The lens also has a limbal ring or pattern, <NUM> (<FIG>). The peripheral portion <NUM> is the portion that is colored according to this invention in order to enhance the appearance of the sclera. The coloring of this peripheral portion of the lens can be opaque, translucent, or somewhere between the two (semi-opaque). It is not necessary that it be uniformly colored either but embodiments according to the invention enhance its appearance, preferably, by providing the sclera with a refreshed, natural appearance. "Opaque" for these purposes means a color that permits an average light transmittance (% T) in the <NUM> to <NUM> range of <NUM> to about <NUM>, preferably <NUM> to about <NUM>% T. "Translucent" for these purposes means a color that permits an average light transmittance (% T) in the <NUM> to <NUM> range of about <NUM> to about <NUM>%, preferably about <NUM> to about <NUM>%T.

<FIG> shows a lens but does not describe the bright coloring being in the form of a geometric pattern according to the claims. In <FIG>, the coloring of the lens periphery, <NUM> is graduated from opaque to translucent or transparent from the inner diameter of the periphery, <NUM> to the outer diameter of the periphery, <NUM> and limbal ring, <NUM>. Central portion, <NUM> is also colored or tinted and can be considered an iris portion given that it on-eye effect is to cover or enhance the iris. This combination provides the most natural iris (the wearer's actual iris) and the contrast of a dark limbal ring while providing the additional benefit of the bright coloring applied to the periphery. The limbal ring can be of any suitable width or pattern that allows the ring to blend naturally with the iris, iris pattern, and white coloring applies to the periphery. The limbal ring can be translucent or opaque. The central portion, <NUM> is typically <NUM>-<NUM> in diameter and is preferably greater than <NUM> in diameter.

<FIG> shows an inventive lens with bright coloring applied to the periphery <NUM> in the form of a geometric pattern. In this case, the pattern takes on the appearance of circles removed from the lens surface (that would otherwise be colored white) so that each circle touches its neighboring circle at a tangent. It can also be thought of as rows and columns of cross shaped brightly colored structures formed by these circles. Patterning comprising geometric shapes can be formed from regularly shaped structures. Any other convenient shapes for conveying a realistic or enhanced sense of color can be used particular where such geometric shapes contribute to a desired hue or shade. The dots used in the patterns of the invention may be of any size and preferably are about <NUM> to about <NUM> in diameter, more preferably about <NUM> to about <NUM> in diameter. Dots aid in blending of the borders of the different elements of the lenses.

In any of the patterns of the invention, the center preferably is clear. However, the center portion may be an area of translucent or opaque color or any combination of opaque and translucent colors.

As used in a lens for either enhancing or altering the wearer's eye color, preferably the limbal ring element is a solid band of color that masks the color of the lens wearer's limbal region and more preferably the masking color is an opaque color. The remaining elements, the spokes, dots and other pattern elements, may be translucent or opaque depending on the desired cosmetic on-eye result.

The color selected for each of the limbal ring and iris pattern elements will be determined by the natural color of the lens wearer's iris and the enhancement or color change desired. Thus, elements may be any color including, without limitation, any of a variety of hues and chromas of blue, green, gray, brown, black yellow, red, or combinations thereof. Preferred colors for the limbal ring include, without limitation, any of the various hues and chromas of black, brown, gray, dark blue and dark green.

The brightly colored element comprising the peripheral portion can be pure white , near white, off white, light yellow, pale blue, light pink, light green, or any combination of the above. Preferably, it is matched so that it does not starkly contrast with the visible portion of the sclera that is not covered by the lens. These colors are obtained by use of TiO<NUM> with higher amounts yielding greater opacity and contrast. The addition of pigments include, without limitation, iron oxide black, iron oxide brown, iron oxide yellow, iron oxide red, titanium dioxide, and the like, and combinations thereof, in small amounts to adjust the whiter colored element. In addition to these pigments, soluble and non-soluble dyes may be used including, without limitation, dichlorotriazine and vinyl sulfone-based dyes. The peripheral portion comprises a colorant with <NUM>% to <NUM>% Ti02 and <NUM>% to <NUM>% clear binding polymer to provide appropriate translucency.

In general, the colored elements, may be made from any organic or inorganic pigment suitable for use in contact lenses, or combinations of such pigments. The opacity may be controlled by varying the concentration of the pigment and titanium dioxide used, with higher amounts yielding greater opacity. Illustrative organic pigments include, without limitation, pthalocyanine blue, pthalocyanine green, carbazole violet, vat orange # <NUM>, and the like and combinations thereof. Examples of useful inorganic pigments include, without limitation, iron oxide black, iron oxide brown, iron oxide yellow, iron oxide red, titanium dioxide, and the like, and combinations thereof. In addition to these pigments, soluble and non-soluble dyes may be used including, without limitation, dichlorotriazine and vinyl sulfone-based dyes. Useful dyes and pigments are commercially available.

The dye or pigment selected may be combined with one or more of a pre-polymer, or binding polymer, and a solvent to form the colorant used to produce the translucent and opaque layers used in the lenses of the invention. Other additives useful in contact lens colorants also may be used. The binding polymers, solvents, and other additives useful in the color layers of the invention are known and either commercially available or methods for their making are known.

The elements may be applied to, or printed on, one or more surfaces of a lens or may be printed onto one or more surfaces of a mold into which a lens forming material will be deposited and cured. In a preferred method for forming lenses incorporating the designs of the invention, a thermoplastic optical mold, made from any suitable material including, without limitation, cyclic polyolefins and polyolefins such as polypropylene or polystyrene resin is used. The elements are deposited onto the desired portion of the molding surface of the mold. By "molding surface" is meant the surface of a mold or mold half used to form a surface of a lens. Preferably, the deposition is carried out by pad printing as follows.

A metal plate, preferably made from steel and more preferably from stainless steel, is covered with a photo resist material that is capable of becoming water insoluble once cured. The elements are selected or designed and then reduced to the desired size using any of a number of techniques such as photographic techniques, placed over the metal plate, and the photo resist material is cured. The plate is subsequently washed with an aqueous solution and the resulting image is etched into the plate to a suitable depth, for example about <NUM> microns. A colorant containing a binding polymer, solvent, and pigment or dye is then deposited onto the elements to fill the depressions with colorant.

The metal plate can also be laser etched using appropriate software and lasers to extract the metal in the area that contains the preferred image, thus creating cavities replicating the image in <NUM> to <NUM> depth. Additionally, laser etching of the preferred pattern can occur on other substrates such as ceramic.

A silicon pad of a geometry suitable for use in printing on the surface and varying hardness, generally about <NUM> to about <NUM>, is pressed against the image on the plate to remove the colorant and the colorant is then dried slightly by evaporation of the solvent. The pad is then pressed against the molding surface of an optical mold. The mold is degassed for up to <NUM> hours to remove excess solvents and oxygen after which the mold is filled with lens material. A complementary mold half is then used to complete the mold assembly and the mold assembly is exposed to conditions suitable to cure the lens material used. Such conditions are well known in the art and will depend upon the lens material selected. Once curing is completed and the lens is released from the mold, it is equilibrated in a buffered saline solution.

In a preferred embodiment, a clear, pre-polymer layer is used, which pre-polymer layer overlays at least the limbal ring and dot patterns and preferably forms the entirety of the lens' outermost surface. The pre-polymer may be any polymer that is capable of dispersing the pigment and any opacifying agent used. In an alternate embodiment, the various patterns or the limbal ring could be placed on the lens or lens molds by inkjet printing.

The invention may be used to provide tinted hard or soft contact lenses made of any known lensforming material, or material suitable for manufacturing such lenses. Preferably, the lenses of the invention are soft contact lenses, the material selected for forming the lenses being any material suitable for producing soft contact lenses. Suitable preferred materials for forming soft contact lenses using the method of the invention include, without limitation, silicone elastomers, silicone-containing macromers including, without limitation, those disclosed in <CIT>, <CIT>, and <CIT>, hydrogels, silicone-containing hydrogels, and the like and combinations thereof. More preferably, the lens is made from a material containing a siloxane functionality, including, without limitation, polydimethyl siloxane macromers, methacryloxypropyl polyalkyl siloxanes, and mixtures thereof, a silicone hydrogel or a hydrogel made of monomers containing hydroxy groups, carboxyl groups, or both and combinations thereof. Materials for making soft contact lenses are well known and commercially available. Preferably, the lens material is acquafilcon, genfilcon, lenefilcon, balafilcon, lotrafilcon, or galyfilcon. In another embodiment, the lens may be made from a conventional hydrogel material, for example etafilcon.

The following non-limiting examples further illustrate the invention.

A binding polymer was made using <NUM> of <NUM>-dodecanethiol ("DODT"), <NUM> lauryl methacrylate ("LMA"), <NUM> methacrylic acid ("MAA"), <NUM> of hydroxyethylmethacrylate ("HEMA"), <NUM> glycerol, <NUM> <NUM>-ethoxy-<NUM>-propanol ("EP"), <NUM> isopropyl lactate ("IPL") and <NUM> <NUM>,<NUM>'-azobis(<NUM>-methylbutyronitrile) ("AMBN"). First adding the DODT, monomers and solvents, except for about <NUM> - <NUM> cc of the IPL, were mixed in a <NUM> liter blue cap bottle and stirred for <NUM> minutes. The mixture was then poured into a <NUM> stainless steel reactor with stirrer and nitrogen. The mixture was stirred and heated for approximately <NUM>. until the temperature was <NUM>. After the temperature was stabilized at <NUM>, the AMBN was dissolved in the remaining IPL and added while opening the nitrogen bleed. The polymerization was allowed to proceed for <NUM>-<NUM> hours after which the temperature was increased to <NUM> and the reaction was completed. The mixture was then allowed to equilibrate to room temperature. The viscosity of the mixture was adjusted as desired by mixing <NUM> parts of IPL with <NUM> part of EP.

A black pad printing ink was prepared by weighing <NUM>. of 1D Black Define (comprised of <NUM> wt% black iron oxide pigment (FeO•Fe<NUM>O<NUM>, <NPL>) in clear base as described in Example <NUM>) into a <NUM> glass jar. <NUM> wt% <NUM>-propanol was also added to the jar. The jar was placed under a mixer and mixed at <NUM> rpm until the appearance of the ink was homogenous.

A white pad printing ink was prepared by weighing <NUM>. of primary white (comprised of <NUM> wt% titanium dioxide pigment (TiO<NUM>, <NPL>) in clear base as described in Example <NUM>) into a <NUM> glass jar. of clear base (described in Example <NUM>) and <NUM> wt% <NUM>-propanol was also added to the jar. The jar was placed under a mixer and mixed at <NUM> rpm until the appearance of the ink was homogenous.

The inks described herein are used to produce the tinted lenses using methods and devices known in the art. These include, for example, the method described in <CIT>.

Claim 1:
A contact lens comprising a center (<NUM>), a central portion (<NUM>) about the center, and a peripheral portion (<NUM>) disposed about said central portion; wherein said peripheral portion is colored with a pattern that graduates to transparent towards the outer diameter of the lens, wherein the central portion contains an area that is meant to cover an iris of a wearer, wherein the central portion is colored and contains a limbal ring (<NUM>), characterized in that the peripheral portion is brightly colored and comprises a colorant with <NUM> to <NUM>% titanium dioxide and <NUM> to <NUM>% clear binding polymer, and wherein said peripheral portion is colored according to a geometric pattern, wherein the geometric pattern is formed from regularly shaped structures.