Patent Publication Number: US-2016246077-A1

Title: Ophthalmic lenses with colorant patterned inserts

Description:
CROSS-REFERENCE TO RELATED APPLICATION 
     This application is a continuation of U.S. application Ser. No. 13/841,186, filed Mar. 15, 2013, which is hereby incorporated by reference in its entirety. 
    
    
     FIELD OF USE 
     This invention describes apparatus and devices with printed colorant patterns on ophthalmic lens device inserts. More specifically, this invention describes various aspects of ophthalmic lens inserts with printed patterns s in the fabrication of an ophthalmic lens device with a Multi-piece Insert. 
     BACKGROUND 
     Traditionally, an ophthalmic device, such as a contact lens, an intraocular lens, or a punctal plug included a biocompatible device with a corrective, cosmetic, or therapeutic quality. A contact lens, for example, can provide one or more of: vision correcting functionality; cosmetic enhancement; and therapeutic effects. Each function is provided by a physical characteristic of the lens. A design incorporating a refractive quality into a lens can provide a vision corrective function. A pigment incorporated into the lens can provide a cosmetic enhancement. An active agent incorporated into a lens can provide a therapeutic functionality. Such physical characteristics may be accomplished without the lens entering into an energized state. 
     More recently, it has been theorized that active components may be incorporated into a contact lens. Some components can include semiconductor devices. Some examples have shown semiconductor devices embedded in a contact lens placed upon animal eyes. However, such devices lack a free standing energizing mechanism. Although wires may be run from a lens to a battery to power such semiconductor devices, and it has been theorized that the devices may be wirelessly powered, no mechanism for such wireless power has been available. 
     The resulting products of ophthalmic lenses containing inserts and components may produce a device that has a visual projection when worn that displays components and interconnects and various other features, which appear different from a standard look of a user&#39;s eye. It may be desirable for some users that the end ophthalmic product have printed features upon it that render an appearance that is similar to a standard look of a user&#39;s eye. Accordingly novel methods, devices, and apparatus relating to the patterning of various components in ophthalmic and biomedical devices formed with inserts are therefore important. 
     SUMMARY 
     The present invention includes innovations relating to the patterning of various components including for example inserts that can be incorporated into an ophthalmic device. Examples of such ophthalmic devices may include, for example a contact lens or a punctal plug. From a more general perspective, numerous other biomedical devices may be relevant within the scope of the invention. In addition, methods and apparatus for forming an ophthalmic lens, with a sealed or encapsulated patterned Multi-piece Insert are presented. In some embodiments, the insert is in an energized state capable of powering a component capable of drawing a current. Non-limiting examples of Components may include one or more of a variable optic lens element, a semiconductor device, and an active or passive electronic device. These components may also include the ability of being activated by an external signal of various types. Some embodiments can also include a cast molded silicone hydrogel contact lens with a rigid or formable energized insert contained within the ophthalmic lens in a biocompatible fashion where the patterning either occurs on surfaces of the insert or at or near the surface of the ophthalmic device itself. 
     In some embodiments, a multi-piece insert device for an ophthalmic lens is disclosed. In some embodiments, this method includes one or both of a first insert back curve piece; at least a first insert front curve piece proximate to the first insert back curve piece; a conductive material upon one or both of the first insert front curve piece and first insert back curve piece; an electronic Component attached to one or both of the first insert front curve piece and first insert back curve piece, wherein an attachment is made at least in part to the conductive material and; a first colorant pattern upon a surface of one or both of the first insert front and first insert back curve pieces. 
     In some embodiments, the multi-piece insert device includes at least a second insert back curve piece in contact with the first back curve piece. In some embodiments, the first colorant pattern is a limbal ring pattern. In some embodiments, the first colorant pattern is an iris pattern. In some other embodiments, the first colorant pattern is a camouflage pattern that obstructs the observance of components within the insert by changing the appearance of them. 
     In some other embodiments, within the first colorant pattern is a first region where the patterning allows visible light to pass through the insert surface. In some other embodiments, between the insert front curve piece and the insert back curve piece and behind the first region where the patterning allows visible light to pass is located a light detector. In some other embodiments, within the first colorant pattern is a second region that comprises a colorant that is opaque to visible light. 
     In some embodiments, between the insert front curve piece and the insert back curve piece and behind the second region in the first colorant pattern is at least a portion of an integrated circuit device. In some embodiments, the limbal ring pattern comprises black colorant. 
     In some embodiments, an ophthalmic lens device is disclosed. In some embodiments, the device includes at least a first insert back curve piece; at least a first insert front curve piece; a conductive material upon one or both of the first insert front curve piece and first insert back curve piece; an electronic component attached to one or both of the first insert front curve piece and first insert back curve piece, wherein an attachment is made at least in part to the conductive material; an encapsulating layer, wherein the insert encapsulating layer is a hydrogel; and a first colorant pattern upon a surface of the encapsulating layer. 
     In some embodiments, the device additionally includes at least a second insert back curve piece. In some other embodiments, the first colorant pattern is a limbal ring pattern. In some other embodiments, the first colorant pattern is an iris pattern. In some other embodiments, the first colorant pattern is a camouflage pattern that obstructs the observance of components within the insert by changing the appearance of them. In some other embodiments, within the first colorant pattern is a first region where the patterning allows visible light to pass through the insert front curve surface. In some embodiments, a light detector is located between the insert front curve piece and the insert back curve piece and behind the first region where the patterning allows visible light to pass. In some other embodiments, within the first colorant pattern is a second region that includes a colorant that is opaque to visible light. In some other embodiments, between the insert front curve piece and the insert back curve piece and behind the second region in the first colorant pattern is at least a portion of an integrated circuit device. In some embodiments, the device additionally includes a liquid meniscus lens element. In some embodiments, the device additionally includes a coating over the insert and pattern, wherein the coating comprises a more consistent adhesion property than the insert and pattern without the coating. In some embodiments, the coating comprises paralene. 
    
    
     
       DESCRIPTION OF THE DRAWINGS 
         FIG. 1  illustrates a mold assembly apparatus according to some embodiments of the present invention. 
         FIG. 2  illustrates an energized ophthalmic lens with a sealed insert embodiment. 
         FIG. 3  illustrates an energized ophthalmic lens with a sealed annular shaped insert embodiment. 
         FIG. 4  illustrates the appearance of a non-patterned ophthalmic lens insert from a frontal perspective. 
         FIG. 5  illustrates the appearance of a patterned ophthalmic lens where the patterning resembles a limbal ring pattern from both a frontal and cross section perspective. 
         FIG. 6  illustrates the appearance of a patterned ophthalmic lens where the patterning resembles an iris pattern from both a frontal and cross section perspective. 
     
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
     The present invention includes methods and apparatus for manufacturing an Ophthalmic Lens with a Multi-piece Insert where portions of the Insert or an Ophthalmic Lens formed from an Insert may include aspects of patterning. In addition, the present invention includes an Ophthalmic Lens with a Multi-piece Insert incorporated into the Ophthalmic Lens including the aspects of patterning. 
     According to the present invention, an Ophthalmic Lens device is formed with an embedded Insert that in some cases includes an Energy Source, such as an electrochemical cell or battery as the storage means for the energy. In some embodiments, a formed Ophthalmic Lens may be patterned in numerous ways including, but not limiting to, printing of patterns upon a fully formed Ophthalmic Lens device, upon a partially formed ophthalmic device, or upon surface portions of an Insert that is subsequently formed into an Ophthalmic Lens device. 
     In some embodiments, a Multi-piece Insert also includes a pattern of circuitry, components, and Energy Sources. Various embodiments can include the Multi-piece Insert locating the pattern of circuitry, components, and Energy Sources around a periphery of an optic zone through which a wearer of a lens would see. In some embodiments, the Multi-piece Insert may include a pattern of circuitry, Components and Energy Sources, which are potentially small enough to not adversely affect the sight of a contact lens wearer. In some embodiments, the Components and the Energy Source are located within, or exterior to, an optical zone. In some embodiments, the patterned formed by these various components within, attached to, or upon the Insert may create a need for a pattern to be placed in such a manner to conceal or obstruct the pattern formed by the components. 
     In some embodiments of the present invention, a Multi-piece Insert is embodied within an Ophthalmic Lens via automation that places an Energy Source in a desired location relative to a mold part used to fashion the lens. The embodiments that place the various Components into the Ophthalmic Lens may employ one or more steps where Components are sealed and adhered into place or Components are encapsulated. 
     In some embodiments, an Energy Source is placed in electrical communication with a Component that can be activated on command and draws electrical current from the Energy Source included within the Ophthalmic Lens. In some embodiments, a component can include, but is not limited to, a semiconductor device, an active or passive electrical device, or an electrically activated machine. In some embodiments, an electrically activated machine may include, but is not limited to, Microelectromechanical systems (MEMS), nanoelectromechanical systems (NEMS), or micromachines. In some embodiments, subsequent to placing the Energy Source and component, a Reactive Mixture can be shaped by the mold part and polymerized to form the Ophthalmic Lens. 
     In the following sections detailed descriptions of embodiments of the invention will be given. The description of both preferred and alternative embodiments are exemplary embodiments only, and it is understood that to those skilled in the art that variations, modifications and alterations may be apparent. It is therefore to be understood that said exemplary embodiments do not limit the scope of the underlying invention. 
     GLOSSARY 
     In this description and claims directed to the presented invention, various terms may be used for which the following definitions will apply: 
     Back Curve Piece: as used herein (and sometimes as an Insert back curve) refers to a solid element of a Multi-piece Insert which when assembled into the said Insert will occupy a location on the side of the lens that is on the back. In an ophthalmic device, such a piece would be located on the side of the Insert that would be closer to the user&#39;s eye surface. In some embodiments, the back curve piece may contain and include a region in the center of an ophthalmic device through which light may proceed into the user&#39;s eye or an optic zone. In some embodiments, the piece may take an annular shape where it does not contain or include some or all of the regions in an optic zone. In some embodiments, there may be multiple back curve pieces of an Insert where one of the Inserts may include the optic zone, while others may be annular or portions of an annulus. 
     Component: as used herein refers to a device capable of drawing electrical current from an Energy Source to perform one or more of a change of logical state or physical state. 
     Encapsulate: as used herein refers to creating a barrier to separate an entity, such as, for example, a Media Insert, from an environment adjacent to the entity. 
     Encapsulant: as used herein refers to a layer formed surrounding an entity, such as, for example, a Media Insert, that creates a barrier to separate the entity from an environment adjacent to the entity. For example, Encapsulants may be comprised of silicone hydrogels, such as Etafilcon, Galyfilcon, Narafilcon, and Senofilcon, or other hydrogel contact lens material. In some embodiments, an Encapsulant may be semipermeable to contain specified substances within the entity and prevent specified substances, such as, for example, water, from entering the entity. 
     Energized: as used herein refers to the state of being able to supply electrical current to or to have electrical energy stored within. 
     Energy: as used herein refers to the capacity of a physical system to do work. Many uses within this invention may relate to the said capacity being able to perform electrical actions in doing work. 
     Energy Source: as used herein refers to device capable of supplying Energy or placing a biomedical device in an Energized state. 
     Energy Harvesters: as used herein refers to device capable of extracting energy from the environment and convert it to electrical energy. 
     Front Curve Piece: as used herein (and sometimes as an Insert front curve) refers to a solid element of a Multi-piece Insert which when assembled into the said Insert will occupy a location on the side of the lens that is on the front. In an ophthalmic device, such a piece would be located on the side of the Insert that would be further from the user&#39;s eye surface. In some embodiments, the piece may contain and include a region in the center of an ophthalmic device through which light may proceed into the user&#39;s eye or an optic zone. In other embodiments, the piece may be annular in shape where it does not contain or include some or all of the regions in an optic zone. In some embodiments, an ophthalmic Insert, may include multiple front curve pieces where one of the pieces may include the optic zone, while others may be annular or portions of an annulus. 
     Ophthalmic Lens: as used herein refers to any ophthalmic device that resides in or on the eye. These devices can provide optical correction or may be cosmetic. For example, the term lens can refer to a contact lens, intraocular lens, overlay lens, ocular Insert, optical Insert or other similar device through which vision is corrected or modified, or through which eye physiology is cosmetically enhanced (e.g. iris color) without impeding vision. In some embodiments, the preferred lenses of the invention are soft contact lenses made from silicone elastomers or hydrogels. 
     Lens forming mixture or “Reactive Mixture” or “RMM” (reactive monomer mixture): as used herein refers to a monomer or prepolymer material that can be cured, crosslinked; or crosslinked to form an Ophthalmic Lens. Various embodiments can include lens-forming mixtures with one or more additives such as, but not limited to, UV blockers, tints, photoinitiators, or catalysts, and other suitable in an ophthalmic lenses, contact lenses, or intraocular lenses. 
     Lens Forming Surface: refers to a surface that is used to mold a lens. In some embodiments, any such surface can have an optical quality surface finish, which indicates that it is sufficiently smooth and formed so that a lens surface fashioned by the polymerization of a lens forming material in contact with the molding surface is optically acceptable. Further, in some embodiments, the lens-forming surface can have a geometry that is necessary to impart to the lens surface the desired optical characteristics, including without limitation, spherical, aspherical and cylinder power, wave front aberration correction, corneal topography correction and the like as well as any combinations thereof. 
     Lithium Ion Cell: as used herein refers to an electrochemical cell where Lithium ions move through the cell to generate electrical energy. This electrochemical cell, typically called a battery, may be reenergized, or recharged in its typical forms. 
     Multi-piece Insert: as used herein refers to a formable or rigid substrate capable of supporting an Energy Source within an Ophthalmic Lens. In some embodiments, the Multi-piece Insert also supports one or more components. 
     Mold: as used herein refers to a rigid or semi-rigid object that may be used to form lenses from uncured formulations. Some preferred molds include two mold parts forming a front curve mold part and a back curve mold part. 
     Optical Zone: as used herein refers to an area of an Ophthalmic Lens through which a wearer of the Ophthalmic Lens sees. 
     Power: as used herein refers to work done or energy transferred per unit of time. 
     Rechargeable or Re-energizable: as used herein refers to a capability of being restored to a state with higher capacity to do work. Many uses within this invention may relate to the capability of being restored with the ability to flow electrical current at a certain rate for certain, reestablished time period. 
     Reenergize or Recharge: as used herein refers to restore to a state with higher capacity to do work. Many uses within this invention may relate to restoring a device to the capability to flow electrical current at a certain rate for certain, reestablished time period. 
     Released from a mold: as used herein means that a lens is completely either separated from the mold, or is only loosely attached so that it can be removed with mild agitation or pushed off with a swab. 
     Stacked Integrated Component Devices: as used herein and sometimes referred to as “SIC-Devices,” refers to the product of packaging technologies that can assemble thin layers of substrates, which may contain electrical and electromechanical devices, into operative integrated devices by means of stacking at least a portion of each layer upon each other. In some embodiments, the layers may comprise component devices of various types, materials, shapes, and sizes. Furthermore, the layers may be made of various device production technologies to fit and assume various contours, as it may be desired. 
     Proceeding to  FIG. 1 , an to form patterned ophthalmic devices containing sealed and encapsulated Inserts is depicted. The apparatus  100  includes an exemplary front curve mold  102  and a matching back curve mold  101 . In some embodiments, an insert  104  and a body of the Ophthalmic Lens device  103  may be found inside these two molds  101  and  102 . In some embodiments, body of Ophthalmic Lens device  103  may be a hydrogel material and the Insert  104  may be surrounded on all surfaces by this material. 
     The Insert  104  may be one of many different types of Inserts. In the depiction of  FIG. 1 , there may be at least one patterned surface  105  in the Insert  104 . There may be many different manners to pattern either the Insert  104  or the body of the Ophthalmic Lens device  103  which form the patterning surface  105 . In some embodiments, the apparatus  100  may create a novel ophthalmic device made up of a combination of components with numerous sealed regions. 
     Referring back to  FIG. 1 , a diagram of an exemplary mold device  100  for an Ophthalmic Lens is illustrated with a Multi-piece Insert  104 . As used herein, a mold device  100  includes a plastic formed to shape a cavity  106  into which a lens-forming mixture can be dispensed such that upon reaction or cure of the lens forming mixture, an Ophthalmic Lens of a desired shape is produced. In some embodiments, the molds and mold device  100  are made up of more than one “mold parts” or “mold pieces”  101 - 102 . The mold parts  101 - 102  can be brought together such that a cavity  105  is formed between the molds parts  101 - 102  in which a lens can be formed. This combination of mold parts  101 - 102  is preferably temporary. Upon formation of the Ophthalmic Lens device, the mold parts  101 - 102  can again be separated for removal of the lens. 
     In some embodiments, at least one mold part  101 - 102  has a portion of its surface in contact with the lens forming mixture such that upon reaction or cure of the lens forming mixture that surface provides a desired shape and form to the portion of the lens with which it is in contact. The same is true of other mold part  101 - 102 . 
     In some embodiments, a mold device  100  is formed from two parts  101 - 102 , a female concave piece (front piece)  102  and a male convex piece (back piece)  101  with a cavity  106  in between them. The portion of the concave surface which makes contact with a lens-forming mixture has the curvature of the front curve of an Ophthalmic Lens to be produced in the mold device  100 , and is sufficiently smooth and formed such that the surface of an Ophthalmic Lens, formed by polymerization of the lens forming mixture-which is in contact with the concave surface—is optically acceptable. 
     In some embodiments, the front mold piece  102  can also have an annular flange integral with, and surrounding a circumferential edge of the Ophthalmic Lens device. In some embodiments, a lens-forming surface can include a surface with an optical quality surface finish, which indicates that it is sufficiently smooth and formed so that a lens surface fashioned by the polymerization of a lens forming material in contact with the molding surface is optically acceptable. Further, in some embodiments, the lens forming surfaces of mold pieces  101 - 102  can have a geometry that is necessary to impart to the lens surface the desired optical characteristics, including without limitation, spherical, aspherical and cylinder power, wave front aberration correction, corneal topography correction and the like as well as any combinations thereof. 
     In some embodiments, a Multi-piece Insert  104  is illustrated onto which an Energy Source and a Component are mounted. The Multi-piece Insert  104  may be any receiving material onto which an Energy Source may be placed, and in some embodiments may also include circuit paths, components and other aspects useful to place the Energy Source in electrical communication with the Component and enable the Component to draw an electrical current from the Energy Source. In some embodiments, sealing and encapsulating  105  allow for a functional Insert to be manufactured in multiple pieces and then reliably assembled and sealed for eventual inclusion into an ophthalmic device, where materials in the ambient of the ophthalmic device and materials inside the Insert device cannot diffuse through the Insert materials or seals  105 . 
     Various embodiments also include placing an Energy Source into a Multi-piece Insert  104  prior to placement of the Multi-piece Insert  104  into a mold portion used to form a lens. The Multi-piece Insert  104  may also include one or more components that will receive an electrical charge via the Energy Source. 
     In some embodiments, a lens with a Multi-piece Insert  104  can include a rigid center and a soft skirt design in which a central rigid optical element is in direct contact with the atmosphere and the corneal surface on respective an anterior and posterior surfaces. Furthermore, a soft skirt of lens material (typically made of hydrogel material) is attached to a periphery of the rigid optical element. In some embodiments, the rigid optical element also acts as a Multi-piece Insert providing energy and functionality to the resulting Ophthalmic Lens. 
     Some additional embodiments include a Multi-piece Insert  104  that is a rigid lens Insert fully encapsulated within a hydrogel matrix. A Multi-piece Insert  104  that is a rigid lens Insert may be manufactured, for example, by using microinjection-molding technology. Embodiments can include, for example, a poly (4-methylpent-1-ene copolymer resin with a diameter of between about 6 mm to 10 mm, a front surface radius of between about 6 mm and 10 mm, a rear surface radius of between about 6 mm and 10 mm, and a center thickness of between about 0.050 mm and 0.5 mm Some exemplary embodiments include an Insert with diameter of about 8.9 mm, a front surface radius of about 7.9 mm, a rear surface radius of about 7, 8 mm, a center thickness of about 0.100 mm, and an edge profile of about 0.050 radius. One exemplary micromolding machine can include the Microsystem 50 five-ton system offered by Battenfield Inc. Some or all of the sealing features, including grooves, slots, lips, knife-edges and the like may be formed during the molding process or later formed by subsequent processing of the molding process. 
     In some embodiments, a Multi-piece Insert can be placed in mold parts  101 - 102  utilized to form an Ophthalmic Lens device. In some embodiments, Mold part  101 - 102  material can include, for example: a polyolefin of one or more of: polypropylene, polystyrene, polyethylene, polymethyl methacrylate, and modified polyolefins. Other molds can include a ceramic or metallic material. 
     In some embodiments, other mold materials that may be combined with one or more additives to form an Ophthalmic Lens mold include, for example, Zieglar-Natta polypropylene resins (sometimes referred to as znPP); a clarified random copolymer for clean molding as per FDA regulation 21 CFR (c) 3.2; a random copolymer (znPP) with ethylene group. 
     In some embodiments, mold parts  101 - 102  may contain polymers such as polypropylene, polyethylene, polystyrene, polymethyl methacrylate, modified polyolefins containing an alicyclic moiety in the main chain, and cyclic polyolefins. This blend can be used on either or both mold parts  101 - 102 . In some embodiments, this blend is used on the back mold part  101 , and the front mold part  102 ; and includes alicyclic co-polymers. 
     In some embodiments, injection molding is utilized according to known techniques, however, embodiments can also include molds fashioned by other techniques including, for example: lathing, diamond turning, or laser cutting. 
     In some other embodiments, Ophthalmic Lens devices are formed on at least one surface of both mold parts  101 - 102 . However, in some embodiments, one surface of a lens may be formed from a mold part  101 - 102  and another surface of a lens can be formed using a lathing method, or any other methods. 
     Proceeding to  FIG. 2 , an example of an unpatterned Ophthalmic Lens device  200  with embedded Insert is depicted in cross section. In some embodiments, a surrounding ophthalmic device shell  210  may be formed by the molding features of  FIG. 1 , and may be made of numerous materials including hydrogel compounds. 
     Additionally, the Ophthalmic Lens device  200  may include an Insert  220 . In some embodiments, the Insert  220  may be made of multiple pieces and have various kinds of seals utilized to complete the Insert  220 . 
     In some embodiments, the Ophthalmic Lens device  200  may also include a component device layer  230  that may include, but not limited to, activation elements, processing elements, energization elements, and sensing elements. In some embodiments, there may be numerous encapsulation schemes that are relevant to the inclusion of such a layer. In addition, in some embodiments, the layers  210  may be adhered to other components  240  such as an active optical device before the resulting Insert is fixed into an ophthalmic device, as is shown in  FIG. 1 . 
     Referring back to  FIG. 2 , an unpatterned version of a formed ophthalmic device and incorporation of various components is illustrated. 
     Proceeding to  FIG. 3 , a close up cross section  300  of the edge of an exemplary ophthalmic device is shown. In some embodiments, a top view  390  of the cross section  300  is illustrated. In some embodiments, the ophthalmic device may be considered full, because in optic zone  310  there may be an Insert or other active components of various kinds. For example, in a meniscus type lens, the region optic zone  310  may be surrounded by two immiscible fluids that form the basis of a meniscus type active lens. In some embodiments, optic zone  310  may represent the front surface of the Insert, and may be a molded separate piece onto which various conductive electrode metal layers may have been deposited. In some embodiments, various electrical components  330  and electrical traces with energization elements  320  are present. 
     In some embodiments, the molded front piece  310  may have a recess  371  molded into it, which will then intersect with the molded, but separate, back piece  360  as shown. In some embodiments, recess  371  may be called a glue groove. In some other embodiments, when front piece and back piece are brought into proximity of each other—is whether before or after the fluids are filled into a cavity that is formed by the two pieces—the back piece may be advanced to firmly register into the groove  371 . Thereafter, an adhesive or sealant may be deposited into the remaining space of the groove  371 . In some embodiments, groove  371  may be located around the entire periphery of the Ophthalmic Lens device itself. In some embodiments, surface  370  may presents an exemplary location where patterns may be placed to create a patterned Insert formed by patterning of the Insert itself. In some other embodiments, other surfaces may be patterned and formed. In addition, in some embodiments encapsulants  331  may define surfaces that may be patterned. In many embodiments, nevertheless, the front facing surface  370  may still be patterned along with any patterning on back curve surfaces  360  or surfaces located on the back curve side. 
     In some other embodiments, an Insert is not a full device as mentioned above, but rather is an annular device where at least a portion of the central portion may be devoid of material. Proceeding to  FIG. 4 , an illustration of such an annular Insert type  400  may be found. The annular Insert  400  may have a front curve piece  410  that may have a front facing surface  470 . In some embodiments, an inner edge  415  defines the inner feature of the annular Insert  400 . 
     In some embodiments, a cross sectional  490  of the annular Insert  400  is disclosed. In the cross section  490 , the front curve piece with surface  470  may extend from molded edges  471  and  472  on the two extremes of the annulus. In some embodiments, there may be a back curve piece  460  that covers and encapsulates a region between the front and back curve pieces. The back curve piece  460  may have an extent that ranges from molded features at  461  and  462 . In some other embodiments, back cure piece  460  may provide additional surfaces upon which patterning features may be formed. 
     In some embodiments, annular Insert  400  may contain numerous components. In a non-limiting exemplary sense, the Insert  400  may contain electronic devices  430 . In some embodiments, electronic devices  430  may be electrically connected by connection features such as solder balls  440 , and sensing elements  420 . In some embodiments, electrical traces may be present within the cavity defined by pieces  470  and  460  as well as energization elements. As with the full device of item  300 , the presence of these numerous components and devices may give an annular device an appearance that would be similar to that shown in  FIG. 2  if there were no patterning performed on at least some of the various surfaces. 
     In some embodiments, a Multi-Piece Insert  400  may have an Optic Zone  415  that includes a variable optic,  412 , powered by an Energy Source  430  located on the Multi-Piece Insert  400 . The Multi-Piece Insert  400  can also include circuitry  425  to control the variable optic  412  included in the optic zone  415 . In some embodiments, a variable optic  412  can be considered a Component. 
     In some embodiments, an Energy Source  430  can be in electrical communication with a Component  435 . The Component  435  can include any device, which responds to an electrical charge with a change in state, such as, for example: a semiconductor type chip; a passive electrical device; or an optical device such as a crystal lens. 
     In some specific embodiments, an Energy Source includes, for example: battery or other electrochemical cell; capacitor; ultracapacitor; supercapacitor; or other storage Component. Some specific embodiments can include a battery located on a Multi-Piece Insert  400  on the periphery of an Ophthalmic Lens outside of the optic zone  415 . 
     Proceeding to  FIG. 5 , appearance of an exemplary patterned Ophthalmic Lens device  500  may be observed. The type of pattern displayed in the Ophthalmic Lens device  500  may be considered a Limbal ring pattern. In some embodiments, a hydrogel  510  may represent an encapsulating layer for an Insert  512 . In some embodiments, the printed pattern may completely cover the Insert  512  from the dense limbic ring  520  to the other side  530 . In some embodiments, internal regions  540  of the Ophthalmic Lens device  500  may locate an active optical device in the optic zone. In some other embodiments, the internal region  540  may be made of hydrogel material alone if the Insert  512  is of annular shape. 
     Referring back to  FIG. 5 , in the cross section below, the nature of the pattern and its ability to cover the material underneath it may be illustrated. Once again, the pattern represents a Limbal Ring pattern and is printed from region  520  to region  530 . Numerous components and features may be located under the pattern including, but not limiting to, integrated circuits  590 , and electrical interconnects  570 . 
     In some embodiments, the pattern may be attached surface of one or more items included in an insert device, such as for example, on a surface of a front curve piece, piece of an Insert device, or a back curve piece of an Insert device. In other embodiments, the pattern may be placed onto the body of the Ophthalmic Lens device. In other embodiments, the pattern may be placed beneath the surface of the Ophthalmic Lens device by an injection process, or alternatively by a multilayered process of forming the body of the Ophthalmic Lens device. 
     In some embodiments, a coating may be applied to the pattern and the Insert to promote consistent adhesion properties between the Insert device with pattern and a hydrogel portion of an Ophthalmic Lens. In some embodiments, the coating may, for example, include paralene. 
     Proceeding to  FIG. 6 , a different type for a patterned Ophthalmic Lens device  600  is depicted. In some embodiments, the pattern that is printed may represent an iris type pattern. In some embodiments, the color of the pattern may assume a wide variety of choices ranging from natural pigmentation types of color to other colors. The patterned lens may have similar defined regions such as, a central optic zone  640 , or a patterned region from an interior ring  630  to an exterior ring  620 . In some embodiments, an Insert may be encapsulated by Ophthalmic Lens materials such as hydrogel. In some other embodiments, skirt  610  that surrounds the Insert and defines the external shape of the Ophthalmic Lens device  600  is present. 
     Referring back to  FIG. 6 , in a cross section, the patterned region between item  620  and  630  is demonstrated. As discussed in  FIG. 5 , the patterned region may cover or obscure underlying components. In some embodiments, the patterned region may further include features such as integrated circuits  690 , and electrical interconnects  670 . In some other embodiments, numerous other features and components may lie under the patterned region within the Ophthalmic Lens device  600 . 
     In some embodiments, a region of transparent patterning, or non-patterning  625  is located within the pattern design. As a non-limiting example, an integrated circuit  690  is depicted. In an exemplary embodiment, the integrated circuit  690  may include functional elements to allow it to detect changes in ambient light in the integrated circuit&#39;s environment, which may occur when a user blinks. There may be numerous reasons that detecting such a blink may be useful, including, for example, the use of blinking to control or signal the desire to change a state in the Ophthalmic Lens. In such an embodiment, it may be desirable for any patterns on the lens to have a window  625  that allows light to pass through the patterned region and into an underlying detector  690 . The window  625  may be made by the lack of pattern-forming material, or by an alternative material, which is transparent to light of certain wavelengths that the detector may detect. In some embodiments, the presence of light on the integrated circuit  690 , except in regions meant for detection, may have adverse effects on the performance of the Ophthalmic Lens device  600 . Therefore, in addition to aesthetic purposes of patterning the lens, functional motivations such as the exclusion of light from circuit elements, extending the life of energization elements, may also be relevant. 
     In some other embodiments, various types of patterning that would conceal components and features from visual recognition are disclosed. In some embodiments, a vast array of possible pattern designs is consistent with the inventive art that has been designed. As a non-limiting example, a design approach based on principles of camouflage may be employed where instead of blocking the appearance of underlying features the printed pattern renders them less recognizable. There may be many patterns that may be employed when patterning ophthalmic devices with Inserts. 
     In some embodiments, an ophthalmic lens can include a lens that includes a silicone-containing component. A “silicone-containing component” is one that contains at least one [—Si—O—] unit in a monomer, macromer, or prepolymer. Preferably, the total Si and attached O are present in the silicone-containing component in an amount greater than about 20 weight percent, and more preferably greater than 30 weight percent of the total molecular weight of the silicone-containing component. Useful silicone-containing components preferably comprise polymerizable functional groups such as, but not limiting to, acrylate, methacrylate, acrylamide, methacrylamide, vinyl, N-vinyl lactam, N-vinylamide, and styryl functional groups. 
     In some embodiments, the ophthalmic lens skirt or an insert encapsulating layer surrounding the Insert may be comprised of standard hydrogel lens formulations. Exemplary materials with characteristics that may provide an acceptable match to numerous Insert materials may include the Narafilcon family; including Narafilcon A and Narafilcon B. Alternatively, exemplary materials with characteristics that may provide an acceptable match to numerous Insert materials may include the Etafilcon family; including Etafilcon A may represent good exemplary material choices. In some embodiments, any materials that may form an acceptable enclosure or partial enclosure of the sealed and encapsulated Inserts may be included. 
     In some embodiments, suitable silicone containing components include compounds of Formula I 
     
       
         
         
             
             
         
       
     
     where: 
     R 1  is independently selected from monovalent reactive groups, monovalent alkyl groups, or monovalent aryl groups, any of the foregoing which may further comprise functionality selected from hydroxy, amino, oxa, carboxy, alkyl carboxy, alkoxy, amido, carbamate, carbonate, halogen or combinations thereof; and monovalent siloxane chains comprising 1-100 Si—O repeat units which may further comprise functionality selected from alkyl, hydroxy, amino, oxa, carboxy, alkyl carboxy, alkoxy, amido, carbamate, halogen or combinations thereof; 
     where b=0 to 500, where it is understood that when b is other than 0, b is a distribution having a mode equal to a stated value; 
     wherein at least one R 1  comprises a monovalent reactive group, and in some embodiments between one and three R 1  comprise monovalent reactive groups. 
     As used herein “monovalent reactive groups” are groups that can undergo free radical and/or cationic polymerization. Non-limiting examples of free radical reactive groups include (meth)acrylates, styryls, vinyls, vinyl ethers, C 1-6  alkyl(meth)acrylates, (meth)acrylamides, C 1-6  alkyl(meth)acrylamides, N-vinyllactams, N-vinylamides, C 2-12  alkenyls, C 2-12  alkenylphenyls, C 2-12  alkenylnaphthyls, C 2-6 alkenylphenylC 1-6 alkyls, O-vinylcarbamates, and O-vinylcarbonates. Non-limiting examples of cationic reactive groups include vinyl ethers, epoxide groups, and mixtures thereof. In some embodiments, the free radical reactive groups comprises (meth)acrylate, acryloxy, (meth)acrylamide, and mixtures thereof. 
     In some embodiments, suitable monovalent alkyl and aryl groups include unsubstituted monovalent C 1  to C 16 alkyl groups, C 6 -C 14  aryl groups, such as substituted and unsubstituted methyl, ethyl, propyl, butyl, 2-hydroxypropyl, propoxypropyl, polyethyleneoxypropyl, combinations thereof, and the like. 
     In some embodiments, b is zero, one R 1  is a monovalent reactive group, and at least three R 1  are selected from monovalent alkyl groups having one to sixteen carbon atoms. In some other embodiments, R 1  are selected from monovalent alkyl groups having one to six carbon atoms. Non-limiting examples of silicone components of this embodiment include 2-methyl-, 2-hydroxy-3-[3-[1,3,3,3-tetramethyl-1-[(trimethylsilyl)oxy]disiloxanyl]propoxy]propyl ester (“SiGMA”), 2-hydroxy-3-methacryloxypropyloxypropyl-tris (trimethylsiloxy) silane, 3-methacryloxypropyltris(trimethylsiloxy)silane (“TRIS”), 3-methacryloxypropylbis(trimethylsiloxy)methylsilane, and 3-methacryloxypropylpentamethyl disiloxane. 
     In some other embodiments, b is 2 to 20, 3 to 15 or in some embodiments 3 to 10; at least one terminal R 1  comprises a monovalent reactive group and the remaining R 1  are selected from monovalent alkyl groups having 1 to 16 carbon atoms. In some other embodiments, R 1  are selected from monovalent alkyl groups having one to six carbon atoms. In yet other embodiments, b is 3 to 15, one terminal R 1  comprises a monovalent reactive group, the other terminal R 1  comprises a monovalent alkyl group having 1 to 6 carbon atoms and the remaining R 1  comprise monovalent alkyl group having 1 to 3 carbon atoms. Non-limiting examples of silicone components of this embodiment include (mono-(2-hydroxy-3-methacryloxypropyl)-propyl ether terminated polydimethylsiloxane (400-1000 MW)) (“OH-mPDMS”), monomethacryloxypropyl terminated mono-n-butyl terminated polydimethylsiloxanes (800-1000 MW), (“mPDMS”). 
     In other embodiments, b is 5 to 400 or from 10 to 300, both terminals R 1  comprise monovalent reactive groups and the remaining R 1  are independently selected from monovalent alkyl groups having 1 to 18 carbon atoms that may have ether linkages between carbon atoms, and may further comprise halogen. 
     In other embodiments, where a silicone hydrogel lens is desired, the lens of the present invention will be made from a reactive mixture comprising at least about 20 and preferably between about 20 and 70% wt silicone containing components based on total weight of reactive monomer components from which the polymer is made. 
     In other embodiments, one to four R 1  comprises a vinyl carbonate or carbamate of the formula: 
     
       
         
         
             
             
         
       
     
     wherein: 
     Y denotes O—, S— or NH—; 
     R denotes, hydrogen or methyl; d is 1, 2, 3 or 4; and q is 0 or 1. 
     The silicone-containing vinyl carbonate or vinyl carbamate monomers specifically include: 1,3-bis[4-(vinyloxycarbonyloxy)but-1-yl]tetramethyl-disiloxane; 3-(vinyloxycarbonylthio) propyl-[tris (trimethylsiloxy)silane]; 3-[tris(trimethylsiloxy)silyl] propyl allyl carbamate; 3-[tris(trimethylsiloxy)silyl] propyl vinyl carbamate; trimethylsilylethyl vinyl carbonate; trimethylsilylmethyl vinyl carbonate, and 
     
       
         
         
             
             
         
       
     
     Where biomedical devices with modulus below about 200 are desired, only one R 1  shall comprise a monovalent reactive group and no more than two of the remaining R 1  groups will comprise monovalent siloxane groups. 
     Another class of silicone-containing components includes polyurethane macromers of the following formulae: Formulae IV-VI 
       (*D*A*D*G) a *D*D*E 1 ; 
       E(*D*G*D*A) a *D*G*D*E 1  or; 
       E(*D*A*D*G) a *D*A*D*E 1    
     wherein: 
     D denotes an alkyl diradical, an alkyl cycloalkyl diradical, a cycloalkyl diradical, an aryl diradical or an alkylaryl diradical having 6 to 30 carbon atoms, 
     G denotes an alkyl diradical, a cycloalkyl diradical, an alkyl cycloalkyl diradical, an aryl diradical or an alkylaryl diradical having 1 to 40 carbon atoms and which may contain ether, thio or amine linkages in the main chain; 
     * denotes a urethane or ureido linkage; 
       a  is at least 1; 
     A denotes a divalent polymeric radical of formula: 
     
       
         
         
             
             
         
       
     
     R 11  independently denotes an alkyl or fluoro-substituted alkyl group having 1 to 10 carbon atoms, which may contain ether linkages between carbon atoms; y is at least 1; and p provides a moiety weight of 400 to 10,000; each of E and E′ independently denotes a polymerizable unsaturated organic radical represented by formula: 
     
       
         
         
             
             
         
       
     
     wherein: R 12  is hydrogen or methyl; R 13  is hydrogen, an alkyl radical having 1 to 6 carbon atoms, or a —CO—Y—R 15  radical wherein Y is —O—, Y—S— or —NH—; R 14  is a divalent radical having 1 to 12 carbon atoms; X denotes —CO— or —OCO—; Z denotes —O— or —NH—; Ar denotes an aromatic radical having 6 to 30 carbon atoms; w is 0 to 6; x is 0 or 1; y is 0 or 1; and z is 0 or 1. 
     A preferred silicone-containing component is a polyurethane macromer represented by the following formula: 
     
       
         
         
             
             
         
       
     
     (the full structure may be understood by joining corresponding asterisk regions, * to *, ** to **)
 
wherein R 16  is a diradical of a diisocyanate after removal of the isocyanate group, such as the diradical of isophorone diisocyanate. Another suitable silicone containing macromer is compound of formula X (in which x+y is a number in the range of 10 to 30) formed by the reaction of fluoroether, hydroxy-terminated polydimethylsiloxane, isophorone diisocyanate and isocyanatoethylmethacrylate.
 
     
       
         
         
             
             
         
       
     
     (the full structure may be understood by joining corresponding asterisk regions, * to *) 
     Other silicone containing components suitable for use in this invention include macromers containing polysiloxane, polyalkylene ether, diisocyanate, polyfluorinated hydrocarbon, polyfluorinated ether and polysaccharide groups; polysiloxanes with a polar fluorinated graft or side group having a hydrogen atom attached to a terminal difluoro-substituted carbon atom; hydrophilic siloxanyl methacrylates containing ether and siloxanyl linkanges and crosslinkable monomers containing polyether and polysiloxanyl groups. Any of the foregoing polysiloxanes can also be used as the silicone containing component in this invention. 
     CONCLUSION 
     The present invention, as described above and as further defined by the claims below, provides methods for patterning Multi-piece Inserts and or Ophthalmic lens formed with embedded Inserts. The present invention also includes apparatus for implementing such methods, as well as ophthalmic lenses formed with the Multi-piece Inserts, which have been patterned.