HK1139019B - Colored contact lens primary packaging - Google Patents

Description

Colored contact lens primary package

RELATED APPLICATIONS

This application claims priority to U.S. provisional patent application No.60/832,324 entitled "Duo Packaging for dispersible Soft Contact luminescence using a Substrate" filed on 21.7.2006 by Stephen d.newman, and U.S. provisional patent application No.60/833,230 entitled "Colored control luminescence Packaging" filed on 24.7.2006 by Stephen d.newman. The present application also claims priority from U.S. patent application No.11/780,987 entitled "color control Lens Primary packaging" filed on 20.7.2007 by Stephen d. All of these applications are fully incorporated herein by reference.

Technical Field

The present system and method relate to contact lens packaging, and more particularly to an improved system and method for forming colored contact lens primary packages while meeting lens packaging standards, including sterility.

Background

Soft disposable contact lenses are typically contained in disposable packages. Since packaging adds to the overall cost of the lens, it should be made as economical as possible without compromising the required packaging standards. Conventional blister packages (as shown in fig. 1 to 3) for disposable lenses (bi-weekly and daily) are composed of a polypropylene container for lenses (hereinafter referred to as a "boat"), which employs a multilayer film composed of polyethylene, aluminum, adhesive and polypropylene as a top layer. The boat is typically an injection moulded part which has a high stiffness but is capable of limited elastic deformation and includes a pre-formed recess. The boat is filled with a suitable storage solution, preferably saline, and houses the individual lenses in situ. The blister pack is then autoclaved with steam and pressure to achieve final sterility. These blister packs are presented to the patient in individually packaged boxes (fig. 4-5) or as a plurality of blister strips.

The marketing goal is to present the contact lens to the patient in an aesthetically pleasing package that simultaneously meets legal requirements for sterility and stability, and allows the patient to safely and easily remove the lens. The lens must remain hydrated while in the package. The package must be well sealed and should minimize the transmission of water vapor through the boat and laminate layer to maximize shelf life and prevent the lens contained therein from drying out. In use, the user removes the laminate from the flange formed on the boat by tearing off the cover to expose the lens immersed in the hydration solution.

A variety of contact lens packages have been traditionally used, particularly disposable contact lens packages that include a preformed blister package. It is a conventional technique in the contact lens industry to provide a preformed rigid package that can protect the lens from damage from applied loads. Examples of conventional blister packs are shown below: U.S. patent nos. 5,704,468; 4,392,569, respectively; 5,620,088, respectively; (ii) a 5,620,088, respectively; 4,691,820; 5,823,327, respectively; 5,853,085, respectively; EP patent document publication nos. 1092645A1; EP patent document publication nos. 1092645; and EP patent publication No. 0129388.

While many contact lens packages exist, they all conventionally include a boat made of polypropylene homopolymer to meet the legal requirements for sterility. While sterility is provided by the use of polypropylene homopolymer, the resulting product is a translucent boat or substrate that does not provide secondary utility.

Summary of The Invention

The present specification provides an economical package without compromising the legal and medical requirements of contact lens packages.

In the embodiments described below, the single-use package provides a number of advantages over prior art blister package concepts. First, the single-use package includes a colorant composition configured to allow for rapid identification and rapid inspection of the lenses contained within the package. In addition to identifying the lens, the colorant composition is also configured to assist the patient in identifying contaminants or other foreign objects in the lens package, or to enhance the decorative appeal of the package, such as to provide psychological information of cleanliness, to enhance compliance with good hygiene practices, or to provide a unique selling point for the finished product.

Further, according to one exemplary embodiment, the present single-use package containing a colorant component may include other additives that provide secondary utility such as enhanced sterility or ultraviolet protection.

According to one exemplary embodiment, a primary contact lens package includes a substrate, wherein the substrate includes a homopolymer and a polymeric masterbatch component.

According to one exemplary embodiment, the masterbatch component is included between about 0.5% and 10.0% of the base material.

In another exemplary embodiment, a method of forming a base member of a single-use contact lens primary package, comprising: a first portion of the base member is formed by a first colored shot of a two shot mold (two shot mold), and a second portion of the base member is formed by a second shot of the two shot mold, wherein the second shot injects only polypropylene homopolymer onto the portion of the base member that will be exposed to the contact lens stored therein.

Drawings

The accompanying drawings illustrate various embodiments of the present system and method and are a part of the specification. The illustrated embodiments are merely examples of the present system and method and do not limit the scope thereof.

Fig. 1 is a plan view of a typical prior art disposable blister contact lens package.

Fig. 2 is a side view of the package of fig. 1 with the lid broken to release the contact lens therein.

Fig. 3 is a perspective view of the partially opened package of fig. 2.

Fig. 4 is a side view illustrating a stacking arrangement for two identical prior art contact lens packages according to one embodiment.

Fig. 5 is a perspective view showing a plurality of blister packs stacked as in fig. 4 and contained in a carton.

Fig. 6 is a top perspective view of a contact lens package according to one exemplary embodiment.

Fig. 7 is a bottom perspective view of a contact lens package according to one exemplary embodiment.

Fig. 8 is a top perspective view of a partially opened contact lens package, according to one exemplary embodiment.

Fig. 9 is a bottom perspective view of a partially opened contact lens package according to one exemplary embodiment.

Fig. 10 is a top perspective view of a center base of a contact lens package according to one exemplary embodiment.

Fig. 11 is a side cross-sectional view of a substrate for use in a contact lens primary package formed from a two-shot mold, according to one exemplary embodiment.

Fig. 12 is a side cross-sectional view of a boat for use in a contact lens primary package formed from a two-shot mold, according to one exemplary embodiment.

Fig. 13 is a flow chart illustrating a method of forming a contact lens package substrate using a two-shot mold, according to one exemplary embodiment.

Throughout the drawings, identical reference numbers designate similar, but not necessarily identical, elements.

Detailed Description

A package for a contact lens and a method for manufacturing the contact lens package are described herein. More specifically, disclosed are packages having a substrate, wherein the substrate, whether a boat-shaped substrate or a planar substrate, includes a color component to assist a patient in locating a contact lens and identifying contaminants that may be present in the package. According to one exemplary embodiment, the color component is provided onto the substrate by adding a masterbatch additive to the homopolymer. Alternatively, according to one exemplary embodiment, the color component is provided onto the substrate by performing a two-shot molding operation. More details of the present exemplary substrate and method of forming the same will be provided in detail below.

As used in this specification and the appended claims, the term "barrier material" generally refers to any material that can come into physical and fluid contact with a contact lens. Although polypropylene is commonly used as a barrier material in contact lens packages, any other material capable of forming a barrier environment for contact lenses can be used in the present articles and methods. According to one exemplary embodiment, the barrier material may comprise any material approved by the Food and Drug Administration (FDA) as being suitable for use in the packaging of sterile medical devices.

In the following description, for purposes of explanation, numerous details are set forth in order to provide a thorough understanding of the present packages and methods for making the same. It will be apparent, however, to one skilled in the art that the present method may be practiced without these specific details. Reference in the specification to "one embodiment" or "an embodiment" means that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment. The appearances of the phrase "in one embodiment" in various places in the specification are not necessarily all referring to the same embodiment.

In the drawings, some elements are not drawn to scale in order to better illustrate the relationship between the components.

Referring to fig. 1 and 2, a typical prior art disposable blister contact lens package (1) formed in two parts is shown. The package (1) comprises a blister pack member (2) which is sealed by a film sheet (3) forming a lid on the package (1), and the film sheet (3) can be torn to release the contact lens (4) located therein.

In fig. 3, the package of fig. 2 is shown, wherein the film (3) is torn to expose the contact lens (4). Typically, the component (2) will be a pre-formed blister pack and comprises a shaped recess (5), the recess (5) providing a recess in which the lens can be placed. The part (2) is typically injection moulded from polypropylene homopolymer and the package is completed with a sealing membrane (3) which cooperates with the flange (6) to form an aseptic seal. The contact lens (4) is immersed in a solution (7) that keeps the lens hydrated until it is removed from the package. As previously mentioned, the conventional method of using polypropylene homopolymer to form blister packages is quite effective in the production of blister package components (2) which have proven to provide the desired sterility, whereas the resulting blister package components (2) are translucent gray in color.

Fig. 4 shows a stacking arrangement for two identical prior art contact lens packages (10 and 11). As can be seen from fig. 4, although the two packages conveniently fit each other, they occupy a thickness greater than the thickness (depth) of one package. Ideally, lens packages should occupy as little space as possible in view of the small size of the contact lenses.

In recent news, some of the eye-infecting bacterial events that occur, such as fusarium keratitis, underscore the necessity of sterile primary contact lens packages, as well as the ability to observe and identify any foreign objects that may be present in the contact lens package. In some rare cases, contaminants may be present in the primary contact lens package itself. However, a significant amount of contamination entering the primary contact lens package is still from the fingers of the patient attempting to remove and put on the contact lens.

According to one exemplary embodiment of the present exemplary system and method, a color component is added to the blister pack member (2). The addition of the color component allows the patient or other user to readily identify any contaminants or foreign objects that may be present in the blister pack member. Moreover, according to one exemplary embodiment, the present blister pack member (2) continues to provide a legal level of sterility.

According to one exemplary embodiment, the color component of the blister pack member (2) that provides contaminant identification contrast includes, but is in no way limited to, a masterbatch component. According to this exemplary embodiment, the masterbatch component includes a carrier; typically, the carrier is the same polymer used in the final molding, but has a higher melt flow index. According to this exemplary embodiment, the carrier is configured to be compatible with the final polymeric article.

According to the present exemplary embodiment, the masterbatch component is basically a color concentrate configured to apply a desired color to a polyolefin resin or a polypropylene resin. In the present exemplary embodiment, the masterbatch may be mixed with the resin using between about 0.5% and 10% loading of homopolymer. Once the masterbatch is mixed with the homopolymer resin, colored plastic parts can be made by conventional molding methods.

A wide variety of colors can be provided using masterbatch color components. Commercially available masterbatch materials are available from a number of suppliers including, but in no way limited to, Ampacet and Clariant. In addition to providing a wide range of hueing through the masterbatch component, many masterbatch suppliers also provide color matching services to match the color of the present blister pack member (2) with a secondary package member or with other blister pack members (2).

According to one exemplary embodiment, while many masterbatch color components may be used to provide a contaminant contrasting color to a blister package component, the masterbatch color components include colorants approved by the FDA for use in food, pharmaceutical, medical device, and cosmetic products. Specifically, according to one exemplary embodiment, the masterbatch color component corresponds to the approved colorants listed in 21CFR 73 and 21CFR 74.

According to one exemplary embodiment, for purposes of example only, the masterbatch color component may include, but is in no way limited to, a commercially available 110194-K white 60 polypropylene masterbatch configured to produce a white blister package component (2). According to this exemplary embodiment, the 110194-K white 60 polypropylene masterbatch includes components adjusted to be as acceptable as indirect food additives as specified in sections 174.5, 177.1520(c)3.2a and 178.3297 of chapter 21 of the federal regulations. According to one exemplary embodiment, the white polypropylene masterbatch comprises titanium dioxide configured to impart a white color to the base polymer.

Although the present example is described in the context of forming a white polypropylene blister pack member, many colors may be used including, but in no way limited to, white, gray, yellow, green, blue, red, purple, orange, brown, pink, black, gold, silver, and the like. Further, although the present example is described in the context of forming a white polypropylene blister package member, any polymer substrate used for a primary contact lens case may receive a color component upon addition of a masterbatch component.

In addition to the contrasting color to provide quick identification of contaminants, the formation of a blister package member (2) comprising a masterbatch component may be used to assist a patient in easily identifying a contact lens contained in the blister package member. For example, the combination of the color of the blister pack member (2) and the non-unitary light color contained in the contact lens can produce a well-known color effect. For example, according to one exemplary embodiment, a yellow substrate may be formed using a masterbatch process, as described above, and used in conjunction with a contact lens having a non-monomeric bluish color. The result is a macroscopic green spot in which the yellow color of the substrate combines with the bluish non-monomer color, allowing the patient to easily identify the contact lens. In addition, any other color seen by the patient will show contamination.

Although the addition of the masterbatch component to the polymer forming the substrate is described for the purpose of adding color to the substrate, other beneficial effects may be accomplished by the masterbatch component, including, but in no way limited to, providing a fragrance or antimicrobial agent to the substrate. According to one exemplary embodiment, the masterbatch component may add a fragrance component to the substrate. When the patient opens the primary contact lens case containing the fragrance composition, a fragrant sensation will be experienced. While many scents may be used, according to one exemplary embodiment, the scent includes a preservative scent or other scent configured to create a sense of sterility for the patient. According to one exemplary embodiment, the preservative scent raises the patient's attention to avoid contamination.

Other benefits may include protection of the primary contact lens package from Ultraviolet (UV) radiation. Conventional blister packages can allow UV access to the lens, which can degrade the polymer upon continued exposure. However, the use of a masterbatch component, such as titanium dioxide, will render the polypropylene substrate UV opaque.

Alternatively, the masterbatch component may be configured to release the antimicrobial agent into a solution contained by the primary contact lens package. In particular, according to one exemplary embodiment, an increasing number of plastic household items are now available that are germicidal in nature. According to one exemplary embodiment, the antimicrobial component in the masterbatch component may include, but is in no way limited to, silver ions, triclosan, and/or trichlorocarbanilide. According to this exemplary embodiment, placing a leached silver layer into the primary lens package will reduce bacterial contamination of the lens from handling during wear.

According to yet another exemplary embodiment, the masterbatch component may also be configured to release an adjunct for the brine. Specifically, according to one exemplary embodiment, an adjunct, such as Hyaluronic Acid (HA) or dexpanthenol, may be configured for release from the main cartridge substrate. According to this exemplary embodiment, the release of the adjunct may be temporarily reduced. However, heating the package, such as during an autoclaving operation, may help release the adjunct.

Although the above examples are described in the context of conventional blister packages (2), many contact lens packages may also be combined with the above-described masterbatch component.

Fig. 6 is a top perspective view of a contact lens package according to an alternative embodiment. As shown in fig. 6, the present exemplary contact lens package (100) includes a central substrate (110) that includes a top sheet member (150) coupled to a top surface of the substrate. According to one exemplary embodiment, the top sheet member (150) is coupled to the top surface of the substrate (110) by a peel connection such that the top sheet member (150) can be separated from the substrate (110) with a constant and low pulling force. Further, as will be described in greater detail below, the top sheet member (150) is coupled to a top surface of the substrate (110) sufficient to permit autoclaving of the exemplary contact lens package (100). Further, fig. 6 shows that the top sheet member (150) may contain different text and/or images including, but in no way limited to, brand name (300), pattern (320), and/or information about the contact lens (310), e.g. for left or right eye, and instructions for use.

Likewise, fig. 7 is a bottom perspective view of the present exemplary contact lens package (100), according to one exemplary embodiment. As shown, the bottom sheet component (160) is coupled to the bottom surface of the substrate (110), opposite the top sheet component (150). As shown, the bottom sheet member (160) may be permanently or securely attached to the bottom surface of the substrate (110) without non-attached portions or other components for removing the bottom sheet member (160) from the substrate. Fig. 7 also shows a gripping end (220) or gripping surface formed on the bottom surface of the base (110).

According to one exemplary embodiment, the exemplary top sheet (150) and the exemplary bottom sheet (160) may comprise laminated foils. The laminated foil may include, but is in no way limited to, a bottom or innermost layer comprising a homogeneous material, such as polypropylene, to ensure sterility of the lens (220), the bottom or innermost layer covering at least the area of the foil that may be in physical or fluid contact with the lens. According to one exemplary embodiment, over the inner layer may be a metal foil layer, such as aluminum, which provides strength and flexibility. The top layer may be formed on top of the aluminum layer and include a polymer such as, but not limited to, polyethylene, polyester, or polyamide.

According to one exemplary embodiment, the exemplary base sheet (160) may also include a laminate foil. As described above, the top or innermost layer of the bottom sheet (160) in physical or fluid contact with the lens (200) comprises a barrier material. In other words, the bottom sheet (160) is designed to maintain the integrity of the package during operation and may include the same layers as the top sheet (150), as described above. The bottom sheet (160) does not have to be separated from the substrate and thus may be permanently attached to the substrate (110), for example, by high temperature heat sealing or other substantially permanent coupling. In an exemplary embodiment, the laminated foil is shorter in length than the substrate such that the bottom sheet covers and attaches to the body end of the substrate, but not the handle portion. Text and images may also be printed on the bottom foil.

Fig. 8 illustrates an exemplary contact lens packaging system (100) including a spring holder (190) disposed in an aperture (180). According to one exemplary embodiment, the spring holder (190) may be located in the aperture (180) as an integral part of the base (110). Alternatively, the spring holder (190) may be a separate component disposed in the aperture (180) without a coupling structure, thereby allowing the spring holder (190) to float within the aperture.

As shown in the bottom perspective view of fig. 9, the bottom sheet member (160) is not removed during removal of the contact lens (200) from the present contact lens packaging system. Conversely, according to one exemplary embodiment, the bottom sheet member (160) is securely attached to the bottom surface of the substrate (110) without contact tabs or any other material that would allow the sheet member to be removed. Also shown in fig. 9, the ridged gripping area (140) facilitates removal of the top sheet member (150).

FIG. 10 is a perspective view of a substrate according to one exemplary embodiment. As shown in fig. 10, the base (110) defines an aperture (180) sized to receive a contact lens (200) and other packaging elements. For example, according to one exemplary embodiment, a shape-restoring element (190), such as a spring disc or sponge, may be located beneath the lens (200).

According to one exemplary embodiment, shown in the cross-sectional view of fig. 11, the substrate (110) may be formed of a variety of materials, including a blocking area (130) that may be exposed to the lens (200). According to one exemplary embodiment, the barrier zone (130) may comprise a homogeneous material, such as natural polypropylene or polypropylene homopolymer, to ensure sterility of the lens. Alternatively, the barrier region (130) may be formed from a number of barrier materials approved by the FDA. According to one exemplary embodiment, the barrier region (130) has a sufficient thickness to provide a desired level of sterility, but at the same time is sufficiently thin to be at least partially translucent. According to this exemplary embodiment, the remainder of the substrate (110) is composed of a large amount of core material (120). Since the core material (120) is not in contact with, and is never exposed to, the lens (200), the core material (120) may comprise substantially any material, thereby providing the ability to include a variety of colors, surface finishes, stiffness, and other desired material properties.

According to the present exemplary configuration, the core material (120) does not contact and is never exposed to the lens (200) or hydration medium. Thus, the packaging requirements for the medical device will not limit the choice of core material (120). For example, according to one exemplary embodiment, the core material (120) may include, but is in no way limited to, glass-filled polypropylene, acrylonitrile butadiene styrene, polystyrene, polyethylene terephthalate, polypropylene copolymers, polymethylpentene, polycarbonate, polysulfone, polyethylene naphthalate, cyclic olefin copolymers, fluorinated ethylene propylene, and the like, to achieve a desired color, finish, shape, and the like.

According to one exemplary embodiment, the package (100) including both the barrier material (130) and the core material (120) may be formed by a two-shot molding process or an overmolding process and allows for significant design flexibility. As previously mentioned, the overmolding process, which will be described below, allows for the formation of a primary contact lens package that helps the patient locate the contact lens and identify potential contamination within the package. More details of the two-shot overmolding process will be provided below.

As previously described, according to one exemplary embodiment, design flexibility in terms of materials, color, surface finish, and mechanical properties may be provided to the present exemplary contact lens package by forming the barrier material (130) portion and the core material (120) portion in a two-shot overmolding process. Fig. 11 illustrates a side cross-sectional view of a contact lens package substrate (110) formed by a overmolding mold, according to one exemplary embodiment. As shown in fig. 11, the substrate (110) includes both a core material (120) and a barrier material coating (130).

According to one exemplary embodiment, the core material (120) may be formed from a variety of materials, including non-FDA approved materials. This flexibility increases the ability to select materials based on color, texture, material properties, cost, and the like. As previously described, the core material may include a masterbatch component to provide a desired color or other visual effect, such as pearlescence, opalescence, or illumination of the core material. According to this exemplary embodiment, the core material (120) may be formed by a first shot of a two-shot molding process. After forming the core material (120), the barrier material overlay (130) may be formed by a second shot of a two-shot molding process. As shown, the above method forms a barrier layer of a coating (130) of a barrier material on a core material (120). Although the formation of the overmolded substrate (110) shown in fig. 11 is described as forming the core (120) first, followed by the barrier material coating (130), the order of operation and formation may be reversed.

According to one exemplary embodiment, the thickness of the barrier material cover layer (130) on the top layer of the core material (120) may be, but is in no way limited to, about 0.01mm, and the core material may have, but is in no way limited to, a thickness of about 0.70 mm. Although the present substrate structure is described in the context of forming a substrate (110) for use with a top sheet component (150) and a bottom sheet component (160), the same principles and practices of using a two-shot process to create a core (120) and a barrier material overlay (130) can also be used with conventional boats, such as those shown in fig. 1-5, as will be described below in connection with fig. 12.

In addition to coating the top layer of the substrate (110) using an overmolding process, the aperture (180) configured to receive the contact lens (200) is also coated with a coating of barrier material (130) to ensure that the contact lens is not exposed to the core material (120) during manufacture or storage. As shown, the inner wall of the orifice (180) is coated with a barrier material (130) to ensure sterility of the contact lens. As shown, the contact lens will be sealed to the outside atmosphere and core (120) by the barrier material (130) on each side and to the outside atmosphere and core (120) by the top sheet member (150) and bottom sheet member (160) on the top and bottom surfaces, respectively. According to one exemplary embodiment, a mold for forming a barrier material (130) on an inner wall of an aperture (180) may be configured to provide a thinner layer of barrier material than is formed on top of a core material (120) in order to ensure sterility of the aperture (180) containing the lens. According to one exemplary embodiment, the thickness of the barrier material (130) on the inner wall of the orifice (180) may vary, but is in no way limited to the range of about 0.10mm to 0.20 mm.

According to one exemplary embodiment, the core material (130) includes a majority of the substrate (110). A barrier material (130) is located on the layer above the core material (120) and surrounding the central aperture (180). The barrier material on top of the substrate (110) can also be used to bond the top sheet component (150) to the substrate (110). For example, the top sheet member (150) may be attached to the substrate (110) by a removable heat seal commonly referred to as a peel seal. The barrier material (130) may be polypropylene and the polypropylene coating the top of the substrate (110) may be combined with the polypropylene on the bottom of the top sheet member (150) by a removable heat seal. The top sheet member may be attached to an area of the top surface of the substrate (110) that is as large as desired to form a seal that does not breach or compromise the sterility of the contact lens (200). Fig. 8 shows a seal trace (170) on the substrate (110) that is wider than that used in the edge sealing of conventional packages. The relatively large seal ensures a robust seal to ensure sterility. According to one exemplary embodiment, the heat seal profile may also include an apex (175) toward the hand-held end (220) of the package that assists the consumer in initiating the breaking of the seal and pulling back on the top sheet member (150).

Fig. 12 illustrates a conventional blister pack member (2) formed using the aforementioned overmolding process, according to one exemplary embodiment. The processes and features described above with respect to the contact lens package having a substrate, a top sheet member, and a bottom sheet member are equally applicable to conventional blister packages. As shown in fig. 12, the core material (120) or substrate is first molded using a colored polymer. A second colorless barrier polymer (130) is then molded on top of the core material (120). Overmolding techniques are well known in the molding industry and may be accomplished using, for example, a dual cavity mold, an appliance rotator, or by simply placing a preform core into the cavity of a second mold.

As previously mentioned, an advantage of overmolding is that a layer of barrier polymer will form between the contact lens/package saline and the colored core (120). Ensuring that the contact lens is surrounded by a layer of barrier polymer allows for more options for colorants for the colored core material. Overmolding also allows for the use of fillers within the core, such as fiberglass and other previously unusable materials.

Exemplary method of manufacture

In one exemplary method, the substrate (110) is manufactured to include a barrier material covering the core material at least in an area that may be in physical or fluid contact with a lens retained in the substrate. The present exemplary method may be accomplished by a variety of manufacturing processes, such as an overmolding process. As shown in fig. 13, the two-shot molding involves injecting a first core material (120) into a single-cavity mold (step 1300). According to one exemplary embodiment, the core material (120) is formed into the shape of the desired substrate using a first shot. Once the first material has begun to cool, a second material is injected (step 1310). Since the materials can be kept separate throughout the process, the barrier material can be kept free from contamination by the core material that would compromise the sterility of the package. According to various embodiments, an overmolding, damascene process, or any other known coating process may also be used to fabricate the bi-material substrate. The flexibility available for designing the package (100) is greatly enhanced because the core material (120) may be selected for having a variety of characteristics such as color, finish, density, strength, other mechanical properties, etc., regardless of how compatible the material is with the sterile lens environment.

Although the above-described example of overmolding is described in the context of providing a colored core for rapid identification of contaminants within a primary contact lens package, the barrier polymer (130) may also be configured to impart a variety of properties to the resulting package. According to one exemplary embodiment, the barrier polymer (130) may include a hydrophilic material located in contact with the lens saline. This exemplary configuration will help to retain saline around the lens when the primary package is opened.

Alternatively, the barrier polymer (130) coating may be a polymer, such as poly (vinyl pyrrolidone). It is well known that such materials absorb coloured substances and other contaminants and can therefore help control residual substances. This will reduce the likelihood of any detrimental reaction of the solution contained within the primary contact lens package due to the presence of such residual materials.

Further, according to one exemplary embodiment, the cladding process described above may be used to use a filler (e.g., glass fibers) within the PP that will strengthen and harden the substrate. The overmolding process prevents contact with the saline. In addition, a deeper masterbatch will improve the decorative appearance and stiffen the substrate.

Additional advantages provided by the above-described overmolding method include the ability to produce in-mold labels. In particular, according to one exemplary embodiment, the holographic element may be formed on the surface of the core material (120) and then covered by the barrier polymer (130). The combination of the holographic element will act as an anti-counterfeiting mark, thereby improving the security of the contact lens package (100).

In summary, the present contact lens packaging systems and methods provide an acceptable method for producing primary contact lens packages having colored substrates without sacrificing safety and efficacy. According to the exemplary embodiments described above, the colored substrate helps the patient identify potential contaminants within the package, helps locate and identify the contact lens, and may provide for secondary effects as well as contaminant absorption.

The preceding description has been presented only to illustrate and describe exemplary embodiments of the systems and methods. It is not intended to be exhaustive or to limit the system and method to any precise form disclosed. Many modifications and variations are possible in light of the above teaching. The scope of the system and method is defined by the appended claims.

Claims (25)

1. A primary contact lens package (100), comprising:

a substrate (110);

the substrate (110) comprises a pre-molded core (120) defining a lens receiving aperture and a coating of barrier material (130), wherein the coating of barrier material (130) is molded over the pre-molded core (120);

the barrier material cover layer (130) is formed of a colorless homopolymer forming a barrier layer in the lens receiving aperture and on the top layer of the substrate, the barrier layer being sufficiently thin to be at least partially translucent;

wherein the pre-molded core (120) comprises a color component configured for providing a contaminant contrast color to the primary contact lens package (100) and allowing for the identification of contaminants within the primary contact lens package (100).

2. The primary contact lens package (100) of claim 1, wherein said color component comprises a masterbatch component.

3. The primary contact lens package (100) of claim 2, wherein said masterbatch component is comprised between 0.5% and 10.0% of said substrate (110).

4. The primary contact lens package (100) of claim 2, wherein said masterbatch component comprises a colorant approved for indirect food contact.

5. The primary contact lens package (100) of claim 2, wherein said masterbatch component comprises a colorant approved for direct food contact.

6. The primary contact lens package (100) of claim 2, wherein said masterbatch component comprises a colorant approved for use in medical devices.

7. The primary contact lens package (100) of claim 2, wherein said masterbatch component comprises at least one of an FDA approved pigment or colorant.

8. The primary contact lens package (300) of claim 2, wherein said masterbatch component comprises titanium dioxide.

9. The primary contact lens package (100) of claim 1, wherein the combination of the color of said substrate (110) and the non-monomeric, light color contained in the contact lens produces a known color effect to aid in identifying the contact lens contained in said primary contact lens package (100).

10. The primary contact lens package (100) of claim 1, wherein said barrier material cover layer (130) has a thickness in the range of 0.01mm to 0.20 mm.

11. The primary contact lens package (100) of claim 1, wherein said pre-molded core (120) comprises a color component.

12. The primary contact lens package (100) of claim 1, wherein said barrier material cover layer (130) further comprises a hydrophilic material.

13. The primary contact lens package (100) of claim 1, wherein said barrier material cover layer (130) further comprises an absorbent polymer.

14. The primary contact lens package (100) of claim 13, wherein said barrier material cover layer (130) comprises polyvinylpyrrolidone.

15. The primary contact lens package (100) of claim 1, wherein said substrate (110) further comprises an additive configured to provide a secondary effect.

16. The primary contact lens package (100) of claim 15, wherein said additive is configured to provide UV protection.

17. A method of forming a base member (110) of a contact lens primary package (100), comprising:

forming a first portion (120) of the base member (110) with a pre-molded colored core material defining a lens receiving aperture, the colored core material configured for providing a contrasting color of contaminants to the contact lens primary package (100) and for allowing identification of contaminants within the contact lens primary package (100); and

injecting a polypropylene homopolymer (130) of a cover layer of barrier material onto a portion of the base member (110) configured for exposure to a contact lens stored within the base member (110), forming a barrier layer in the lens receiving aperture and on a top layer of the base member.

18. The method of claim 17, comprising adding a masterbatch component to the base polymer.

19. The method according to claim 18, wherein the masterbatch component is comprised between 0.5% and 10.0% of the base member (110).

20. The method of claim 18, wherein the masterbatch component comprises a colorant approved for indirect and contact with food.

21. The method of claim 18, wherein the masterbatch component comprises a colorant approved for direct food contact.

22. The method of claim 18, wherein the masterbatch component comprises a colorant approved for use in a medical device.

23. The method of claim 18, wherein the masterbatch component comprises FDA approved pigments and colorants.

24. The method of claim 18, wherein the masterbatch component comprises titanium dioxide.

25. The method of claim 18, wherein the combination of colors of the base member (110) and the non-monomeric light color contained in the contact lens produces a known color effect to aid in identifying the contact lens contained in the contact lens primary package (100).