CONTACT LENS PACKAGES AND METHODS OF HANDLING AND MANUFACTURE

Abstract

The present invention relates to improved contact lens packages and methods of use and manufacture/assembly. A contact lens package houses a contact lens and packaging solution and is configured to lift the contact lens out of the packaging solution when force is applied to a lever of the package and/or when the package is squeezed by the user.

Claims

1. A contact lens package that houses a contact lens and packaging solution wherein the package is configured to lift the contact lens out of the packaging solution when the package is squeezed by a user.

2. The contact lens package of claim 1, wherein the package comprises a lever configured to hinge along a pivot line in a base of the package when a force is applied to the lever; and a lens support configured such that the force applied to the lever causes the lens support to lift the contact lens out of the packaging solution.

3. The contact lens package of claim 2, wherein the package is configured such that the force being applied to the lever causes the lens support to lift the contact lens out of the packaging solution in a position on the lens support capable of single-touch transfer by the user.

4. The contact lens package of claim 2, wherein the lever is a discrete component that is coupled to the base by an attachment means.

5. The contact lens package of claim 2, wherein the pivot line is defined by at least one void in the base.

6. The contact lens package of claim 2, wherein the pivot line is imparted into the base by one or more of: a crease, a cut, a thinned line, and an etch.

7. The contact lens package of claim 2, wherein the base is composed of a relatively rigid material.

8. The contact lens package of claim 2, wherein the base and the lens support are a single unitary component.

9. The contact lens package of claim 2, wherein the lever and the lens support are a single unitary component.

10. The contact lens package of claim 2, wherein the lens support is coupled to the base by at least one of: i) a laser weld; ii) heat; iii) an ultrasonic weld; and iv) an adhesive.

11. The contact lens package of claim 2, wherein the base comprises at least one finger engagement feature configured to i) aid a user in grasping the package or i) direct the application of force such that the lever hinges downward.

12. The contact lens package of claim 11, wherein the at least one finger engagement feature comprises a protrusion in the base at a distal end of the package.

13. The contact lens package of claim 11, wherein the at least one finger engagement feature comprises an overhang along at least a portion of the package's periphery.

14. The contact lens package of claim 11, wherein the at least one finger engagement feature comprises a dimple sized to accommodate a finger or thumb of the user, wherein the dimple is positioned at an end of the base proximal to the user.

15. The contact lens package of claim 11, wherein the at least one finger engagement feature comprises a proximal finger engagement feature positioned at an end of the base proximal to the user and a distal finger engagement feature positioned at an end of the base distal to the user.

16. The contact lens package of claim 2, wherein a lid of the package comprises a lens facing surface that extends downward into the cavity above the contact lens when the package is in an unopened state.

17. The contact lens package of claim 16, wherein the lens facing surface and lens support are configured within the cavity such that the optical zone of the contact lens is suspended in the packaging solution between the lens facing surface and lens support when the package is in an unopened state.

18. The contact lens package of claim 1, wherein the package houses the contact lens in a convex position when the package is in an unopened or opened state.

19. The contact lens package of claim 2, wherein the lens support has a profile that does not substantially match the contact lens's profile.

20. The contact lens package of claim 2, wherein when the package is an opened state the wetted contact area between the lens support and the contact lens is less than about 30 mm.sup.2, less than about 25 mm.sup.2, or less than about 20 mm.sup.2.

21. The contact lens package of claim 2, comprising at least one lens facing surface in the cavity above a convex side of the contact lens, wherein when the package is in an unopened state the at least one lens facing surface is configured to align the contact lens over the lens support; or protect the contact lens against significant optical damage due to gravitational, mechanical, or air-induced forces.

22. The contact lens package of claim 2, comprising a lid insert, wherein the lid insert is attached to an inner surface of the lid.

23. The contact lens package of claim 22, wherein the lid insert includes at least one alignment feature.

24. The contact lens package of claim 22, wherein the lid insert includes at least one lock-out feature.

Description

IV. BRIEF DESCRIPTION OF THE DRAWINGS

[0014] The foregoing and other features and advantages of the invention will be apparent from the following, more particular description of preferred embodiments of the invention, as illustrated in the accompanying drawings.

[0015] FIGS. 1A-D illustrate steps of opening a contact lens package according to an exemplary embodiment of the present invention.

[0016] FIG. 2 illustrates a perspective view of a contact lens package in an opened state according to an embodiment.

[0017] FIG. 3 illustrates an exploded perspective view of a contact lens package according to an embodiment.

[0018] FIG. 4 illustrates a close-up view of a lid insert in a cavity of an embodiment.

[0019] FIGS. 5A and 5B illustrate a cross-sectional view of a contact lens package in an unopened state according to an embodiment.

[0020] FIG. 6 illustrates air entry guides of a contact lens package according to an embodiment.

[0021] FIGS. 7A and 7B illustrate a lens support of an embodiment in a side and top view, respectively.

[0022] FIGS. 8A and 8B illustrate a lens support of an alternative embodiment in a side and top view, respectively.

[0023] FIG. 9 illustrates contact lens packages of an embodiment in a nested configuration.

[0024] FIG. 10 illustrates exemplary methods of manufacture of a contact lens package according to certain embodiments.

[0025] FIGS. 11-25 illustrate exemplary lens supports.

V. DETAILED DESCRIPTION

[0026] Reference will now be made in detail to representative embodiments illustrated in the accompanying drawings wherein reference numerals indicate certain elements. The following descriptions are not intended to limit the myriad embodiments to one preferred embodiment.

[0027] To the contrary, it is intended to cover alternatives, modifications, and equivalents as can be included within the spirit and scope of the described embodiments as defined by the appended claims.

[0028] References to “one embodiment,” “an embodiment,” “some embodiments,” “an example embodiment,” etc., indicate that the embodiment described may include a particular feature, structure, aspect, or characteristic, but every embodiment may not necessarily include the particular feature, structure, or characteristic. Moreover, such phrases are not necessarily referring to the same embodiment. Further, when a particular feature, structure, aspect, or characteristic is described in connection with an embodiment, it is submitted that it is within the knowledge of one skilled in the art to effect such feature, structure, or characteristic in connection with other embodiments whether or not explicitly described.

[0029] As used herein, the following terms have the following meaning. A benefit of the certain embodiments the present invention is that they facilitate consistent single-touch lens transfer from the package to a wearer's finger, and then from the finger to the wearer's eye without the lens inverting, falling off the finger or further manipulation. Consistent lens transfer includes a transfer rate of at least about 70%, at least about 80% or at least about 90% transfer on the first touch of the finger (or “dab”). The lens also desirably “sits up” on the finger without collapsing or inverting and then transfers to the eye when placed there. Packages of certain embodiments may provide the desired single-touch transfer across a range of finger sizes, and dab pressures. Environmental conditions such as the temperature and whether the finger is wet or dry may also impact transfer rate, with higher temperatures generally improving lens transfer.

[0030] Lens(es) or contact lens(es) refer to ophthalmic devices that reside on the eye. They have a generally hemispheric shape and can provide optical correction, cosmetic enhancement, UV blocking and visible light or glare reduction, therapeutic effect, including wound healing, delivery of drugs or neutraceuticals, diagnostic evaluation or monitoring, or any combination thereof. The term lens includes soft hydrogel contact lenses, which are generally provided to the consumer in a package in the hydrated state, and have a relatively low moduli, which allows them to conform to the cornea. Contact lenses suitable for use with the packages of the present invention include all hydrated contact lenses, including conventional and silicone hydrogel contact lenses.

[0031] A hydrogel is a hydrated crosslinked polymeric system that contains water in an equilibrium state, and may contain at least about 25%, or at least 35% water in the hydrated state. Hydrogels typically are oxygen permeable and biocompatible, making them excellent materials for producing contact lenses.

[0032] Conventional hydrogel contact lenses do not contain silicone containing components, and generally have higher water content, lower oxygen permeability, moduli, and shape memories than silicone hydrogels. Conventional hydrogels are prepared from monomeric mixtures predominantly containing hydrophilic monomers, such as 2-hydroxyethyl methacrylate (“HEMA”), N-vinyl pyrrolidone (“NVP”) or polyvinyl alcohols. U.S. Pat. Nos. 4,495,313, 4,889,664 and 5,039,459 disclose the formation of conventional hydrogels. Conventional hydrogels may be ionic or non-ionic and include polymacon, etafilcon, nelfilcon, ocufilcon lenefilcon and the like. The oxygen permeability of these conventional hydrogel materials is typically below 20-30 barrers.

[0033] Silicon hydrogel formulations include balafilcon samfilcon, lotrafilcon A and B, delfilcon, galyfilcon, senofilcon A, B and C, narafilcon, comfilcon, formofilcon, riofilcon, fanfilcon, stenfilcon, somofilcon, kalifilcon and the like. “Silicone hydrogels” refer to polymeric networks made from at least one hydrophilic component and at least one silicone-containing component. Silicone hydrogels may have moduli in the range of 60-200, 60-150 or 80-130 psi, water contents in the range of 20 to 60%. Examples of silicone hydrogels include acquafilcon, asmofilcon, balafilcon, comfilcon, delefilcon, enfilcon, fanfilcon, formofilcon, galyfilcon, lotrafilcon, narafilcon, riofilcon, samfilcon, senofilcon, somofilcon, and stenfilcon, verofilcon, including all of their variants, as well as silicone hydrogels as prepared in U.S. Pat. Nos. 4,659,782, 4,659,783, 5,244,981, 5,314,960, 5,331,067, 5,371,147, 5,998,498, 6,087,415, 5,760,100, 5,776,999, 5,789,461, 5,849,811, 5,965,631, 6,367,929, 6,822,016, 6,867,245, 6,943,203, 7,247,692, 7,249,848, 7,553,880, 7,666,921, 7,786,185, 7,956,131, 8,022,158, 8,273,802, 8,399,538, 8,470,906, 8,450,387, 8,487,058, 8,507,577, 8,637,621, 8,703,891, 8,937,110, 8,937,111, 8,940,812, 9,056,878, 9,057,821, 9,125,808, 9,140,825, 9156,934, 9,170,349, 9,244,196, 9,244,197, 9,260,544, 9,297,928, 9,297,929 as well as WO 03/22321, WO 2008/061992, and US 2010/0048847. These patents are hereby incorporated by reference in their entireties. Silicone hydrogels may have higher shape memory than conventional contact lenses.

[0034] Hydrogel lenses are viscoelastic materials. Contact lenses can form optical distortions if the lens interacts with either the package or any air bubble in the package. The extent of the optical distortions, and the length of time needed for the distortions to relax out will vary depending on the chemistry, and to a lesser extent, geometry of the lens. Conventional lens materials, such as polyhydroxyethyl methacrylate-based lenses like etafilcon A or polymacon have low loss modulus and tan delta compared to silicone hydrogels and may form fewer and less severe optical distortions as a result of contact with packaging. The incorporation of silicones (which generally increase the bulk elastic response), wetting agents such as PVP (which generally increase the viscous response) or coatings of conventional hydrogel materials (which may lower the elastic response at the lens interface) can alter the lens viscoelastic properties. Conventional hydrogel contact lenses and silicone hydrogel contact lenses having short or stiff crosslinking agents and or stiffening agent have short shape memories and may be less susceptible to deformation during storage. As used herein, high or higher shape memory hydrogels display optical distortions from contact with an air bubble or package of at least about 0.18 after 5 weeks of accelerated aging at 55° C. Viscoelastic properties, including loss modulus and tan delta, can be measured using a dynamic mechanical analysis.

[0035] The contact lenses can be of any geometry or power, and have a generally hemispherical shape, with a concave posterior side which rests against the eye when in use and a convex anterior side which faces away from the eye and is contacted by the eyelid during blinking.

[0036] The center or apex of the lens is the center of the lens optic zone. The optic zone provides optical correction and may have a diameter between about 7 mm and about 10 mm. The lens periphery or lens edge is the edge where the anterior and posterior sides meet.

[0037] The wetted lens is the contact lens and any residual packaging solution attached to it after packaging solution drainage. Wetted contact is the aggregated contact area between the wetted lens and lens support.

[0038] Embodiments may include a lens support surrounded by a sealable cavity also interchangeably referred to as a chamber. The cavity may have any convenient form and may comprise a package base and at least a lid, each of which are described in detail below. As used herein, the phrases “the lid”, “a lid”, “the base” and “a base” encompass both the singular and plural. The lid and package base are sealed to each other to form a cavity which holds the contact lens, support and packaging solution in a sterile state during shipping and storage prior to use. The contact lens package is made from materials which are compatible with the contact lens and solution, as well as retortable and biologically inert.

[0039] “Film” or “multilayer film” are films used to seal the package and are often referred to as lidstock. Multilayer films used in conventional contact lens packages may be used in the packages of the present invention as the base, a component of the lid, or both. Multilayer films comprise a plurality of layers, including barrier layers, including foil layers, or coatings, seal layers, which seal the film to the rest of the package, and may also comprise additional layers selected from peel initiation layers, lamination layers, and layers that improve other package properties like stiffness, temperature resistance, printability, puncture resistance, barrier resistance to water or oxygen and the like. The multilayer films form a steam sterilizable (retortable) seal. The multilayer film can include PET, BON or OPP films layers to increase stiffness and temperature resistance, or to EVOH or PVDC coatings to improve barrier resistance to oxygen or moisture vapor.

[0040] An “unopened state” or “unopened” as used herein refers to a contact lens package that is closed and houses a contact lens in solution.

[0041] An “opened state” or “opened” as used herein refers to a contact lens package after the sterile seal has been broken. Depending on the context described herein, the open state extends to the state of the package when the user has manipulated the package to cause the lens to be lifted out of the packaging solution for transfer by the user.

[0042] A “wearer” or “user” as used herein refers to a person opening a contact lens package. The user is generally referred to as the person who both opens the package and transfers the contact lens contained therein to their eye. However, the user in some contexts may be a person handling the lens package on behalf of the wearer, such an eye care provider (“ECP”) or another individual demonstrating for or assisting the wearer.

[0043] Packaging solution is any physiologically compatible solution, which is compatible with the selected lens material and packaging. Packaging solutions include buffered solutions having a physiological pH, such as buffered saline solutions. The packaging solution may contain known components, including buffers, pH and tonicity adjusting agents, lubricants, wetting agents, nutraceuticals, pharmaceuticals, in package coating components and the like.

[0044] The package base may form the bottom of the package. It can be made from any material suitable for packaging medical devices, including plastic. The packaging lid generally resides at the upper portion the package and seals with the base to form a cavity containing at least a portion of the lens support, lens, and packaging solution. The lid may be made from any material suitable for packaging medical devices, including a molded sheet of foil or plastic, laminate films, or plastic. Packages comprising plastic for one structure and foil or laminated films as the other, or packages comprising foil or laminated films as the outer layer for the lid and base are known in the art and are examples of suitable combinations.

[0045] References throughout this description to injection molding processes and the use of materials conventionally applied to injection molding should be understood as exemplary. Those of skill in the art will appreciate that other means of manufacture are possible within the scope of the appended claims, including but not limited to alternative molding processes, thermoforming, 3D printing, and the like. Likewise, references to heat seals and heat sealing are exemplary to embodiments described herein. Other means of securing packaging components will be apparent to those skilled in the art, including the use of adhesive, glue, thermal bonding, welding such as heat, ultrasonic or laser welding, or a mechanical trap, and the like.

[0046] Certain aspects of the invention may serve to reduce or prevent significant optical damage to the contact lens due to interactions with air bubbles or the interior of the lens package that may arise during storage or transit due to gravitational or other forces, such as mechanical pressure being applied from outside of the package. As used herein, significant optical damage means a root-mean-squared (RMS) value equal or greater than about 0.08 μm.

[0047] With reference to the figures, FIGS. 1A-1D illustrate steps of handling a contact lens package containing a contact lens in packaging solution according to an exemplary embodiment of the present invention. An unopened contact lens package 100 having a lid 106 and a base 110 is shown at FIG. 1A. In this embodiment, the lid 106 is a multilayer film, also referred to herein as the foil, and the base 110 is composed of a thermoplastic polymer, such as polypropylene plastic. While in this embodiment the lid 106 takes the form of a relatively flexible material (i.e., multilayer film) and the base 110 a relatively rigid material, it should be appreciated that other embodiments may include substantially rigid components for both the lid and the base. For example, in some embodiments, the base and lid both could be composed of a polypropylene plastic or other relatively rigid material. Base 110 includes a pivot line 114 along which a portion of the base that forms a lever 118 can hinge when force is applied to the lever 118.

[0048] Base 110 further includes several optional finger engagement features 122a-122c to assist the user with handling the contact lens package during the opening process. A finger dimple 122a may be sized to accommodate a finger or thumb of the user is disposed at the end of the base 110 proximal to the user; an overhang 122b along a peripheral edge of the base 110; and a protrusion 122c is disposed at the end of package 118 distal to the user. Finger dimple 122a in this embodiment is also angled downward such that a force, e.g., pressure applied by a thumb of the user, causes the lever 118 to hinge downward at the pivot line 114. Package 100 in this embodiment is further configured with a profile that slopes from proximal to distal end to further encourage a downward moment at the lever, for example when the lever is pressed down or the when the package is squeezed by the user, i.e., when the user applies pressure by hand at opposing ends of the package, i.e., via a finger at one end and a thumb at the other. In this embodiment, package 100 is configured such that the squeezing forces are applied at the distal and proximal ends. However, alternative embodiments are possible whereby the opposing forces involved in squeezing are applied at alternative opposing ends of the package, such as but not limited to the sides, left and right, of the package.

[0049] In a first step shown in FIG. 1B, a user holds an unopened contact lens package 100 by its base 110. As illustrated, a user's grip upon the package 100 may be improved by one or more finger engagement features 122a-c positioned and configured to provide a more secure grasp upon the package and/or to aid in the application of force that, in a later step, causes a contact lens contained in the package to be lifted for presentation to the user and transfer to the user's eye. Finger dimple 106 is positioned on lever 118 of base 110 and is sized for a thumb 126 of the user to grip the package. At the opposite end of package 100, the user may grasp the package as shown by positioning a finger securely under an overhang 122b and against a protrusion 122c at the end of the base 110. In the case of an overhang, the overhanging region may be curved or may be flattened to provide an increased area across which an opposing force can be supplied when the package is squeezed. Next, the user may open the package by opening the lid 106, which in this embodiment involves the user peeling open the foil 106 from the proximal end of the base 110 to the distal end in the direction shown by arrow 134, thus breaking a sterile seal between the foil (lid) 106 and base 110. Although not required, in this preferred embodiment the package is optimized for the user to grasp the base with one hand and peel open the lid 106 with the other hand.

[0050] As illustrated at step shown in FIG. 1C, the package lid 106 has been opened, either by complete removal of the lid as shown in the illustration or, alternatively, by partial removal sufficient to substantially expose lens cavity 136, which houses a contact lens 138 suspended in packaging solution (not illustrated) above a lens support 140. With the package 100 open, the user then applies a force 142 to lever 118. In this embodiment, the package is configured to be squeezed by the user whereby the user's hand or hands supply opposing forces 142 and 146 at the proximal and distal ends of the package, respectfully, thereby generating a more significant force upon lever 118.

[0051] Turning to FIG. 1D, the force applied to the lever by the user causes the lens support 140 to lift the contact lens 138 out of the packaging solution (not illustrated). Ideally, a lens support is configured to lift a contact lens high enough above the package cavity that the lens is facing the user, and is thus visible and transferable from the support, but not so high that the lens slides off the support under the force of gravity. This may be accomplished by an angle of lift of between about 15° to 60° relative to the horizontal plane that defines the top of the base when force is applied by the user. A lens support preferably is configured so that, when lifted in this manner, packaging solution drains away from the contact lens sufficiently to enable single-touch transfer by the user, as in the exemplary the embodiment illustrated where the user transfers the contact lens 138 from the lens support 140 by tapping (also referred interchangeably as “dabbing”) a convex surface of the contact lens 138 such that the tapping causes the contact lens to release from the lens support 138 and adhere to a finger 154 of the user.

[0052] In this embodiment, contact lens 138 conveniently is presented to the wearer in a convex orientation, meaning that convex side of the lens 138 is accessible to the wearer without the need to reorient the lens before placing the concave side of the lens onto the wearer's eye surface. It will be appreciated however that other orientations, such as the concave orientation of traditional blister packages, are possible within the scope of invention. Transfer of the contact lens 138 from the lens support 140 may be performed by a wearer's finger 154, either directly touching the lens or indirectly by way of an applicator film (e.g., as described in US20190046353) or other covering applied to the finger, or may be performed by another transfer means, such as a manual or automatic applicator device or tool. Upon transfer of the contact lens 138 from the package 100, the lens rests on the finger 154 (or other transfer means), as shown in step illustrated, with the convex side of contact lens 138 against the finger 154 and the concave side of the lens 138 oriented for direct application to the user's eye surface.

[0053] Turning now to FIGS. 2 and 3, FIG. 2 illustrates a perspective view of contact lens package 100 in an opened state in which lens support 140 has lifted contact lens 138 out of the packaging solution (not illustrated). FIG. 3 illustrates an exploded perspective view of contact lens package 100. Contact lens package 100 includes base 110 that has a proximal end (A) and distal end (B). At its distal end (B), base 110 includes a cavity 136 that houses a contact lens 138 in packaging solution and a lever 118 configured to hinge along a pivot line 114 in the base when a force is applied to lever 118. In this embodiment, lever 118 is formed as a portion of a unitary component that composes the base 118. More specifically, base 110, including lever 118, is formed as a unitary injection-molded polypropylene plastic part. Alternative materials and processes for forming the base will be appreciated by those skilled in the art, including thermoforming and 3D printing (using materials such ABS, PLA, HIPS, PETG, Nylon, or others). Preferably, the material used for the base is relatively rigid, having a glass transition temperature (T.sub.g) of about 125C as measured in accordance with ASTM D1238-10 (Standard Test method for Melt Flow Rates of Thermoplastics by Extrusion Plastometer). In this embodiment, pivot line 114 is defined by multiple voids 158 in the base. Voids 158 are positioned in a linear configuration along a horizontal axis at a point along which it lever 118 hinges. The absence of material that creates voids 158 provides sufficient relief along a line in the base material to cause lever 118 to hinge at the desired position when force is applied to the lever by a user. The distance of the lifting arm, i.e., the distance from the pivot line to the center of the contact lens when resting on the support is between about 10-12 mm, and preferably between 12-17 mm. The use of one or more voids is merely one of myriad ways that a pivot line may be defined within the scope of the invention. For example, in other embodiments in which the lever is formed in the same material as the remainder of the base, the pivot line may be created by creasing the plastic laterally at the desired location by molding the material to be thinner along the pivot line, and/or by cutting, etching or otherwise imparting a pivot line into the base material. Furthermore, in embodiments in which the lever takes the form of a discrete component, the pivot line may merely represent the horizontal interface between the lever and remainder of the base. In such embodiments, hinging along the pivot line may be effected by a hinge component, a rotatable interlocking attachment, or the like. It should be appreciated that alternative embodiments are possible within the scope of the invention in which the lever is a discrete component coupled to the remainder of the base by an attachment means. For example, a lever may be formed as a separate injection molded part and then attached to a separately molded (or printed, etc.) part that forms the rest of the base via an array of attachment means, including laser welding, ultrasonic welding, adhesive, mechanical attachment, heat staking, or the like.

[0054] The underside of the base may be sloped, as in the embodiment illustrated, to enable the packages to “nest” thereby allowing more compact secondary packaging during storage and transport (as described further with reference to FIG. 9) in addition to reducing the amount of primary packaging material and packaging solution necessary to keep the contact lens hydrated. In this example, base 110 slopes from the proximal end (A) to distal end (B) at an angle of approximately 14° and has a footprint of approximately 29 mm in width, 44 mm in length, and 9.5 mm in height. Preferred slopes have a range of between about 10-20°, but the slope may be made even steeper, e.g., about 20-30°, as desired. The base includes a well, i.e., cavity 136, formed in the tapered area in which the contact lens 138 and lens support 140 are housed when package 100 is unopened. In this embodiment, the cavity has a volume of approximately 2240 μl which is dosed with approximately 2080 μL of packaging solution, which is sufficient to fully submerge the contact lens 138 within the cavity 136. The foil lid 106 is secured to the base 110 via a retortable seal formed between bead 152 on the upper surface of the base around the perimeter of the cavity 136. This seal may be formed by well-known heat-sealing techniques and associated apparatuses.

[0055] Finger engagement feature (dimple) 122a is sized to accommodate a finger or thumb of the user is disposed at the end of the base 110 proximal to the user. Finger dimple 122a in this embodiment is also angled downward such that a force, e.g., pressure applied by a thumb of the user, causes the lever 118 to hinge downward at the pivot line 114. The position of the finger dimple position of this dimple and the finger of the user relative to the pivot line affects the amount of squeeze force necessary to cause the lever to hinge along the pivot line. In this example, the dimple depth below the pivot line is 4.5 mm when measured from the seal level to the base of the dimple.

[0056] A lens support 140 is coupled to the lever 118 so that force applied to the lever 118 causes the lens support 140 to lift the contact lens 138 out of the packaging solution. In the embodiment illustrated, lens support 140 is a separately molded (or printed) component that is fixedly attached to the lever 118 portion of the base. Attachment is made here via a stake 162 formed in the lever portion of the base material. Lens support 140 has an opening 166 corresponding to the stake 162 so that, when lens support 140 is placed onto the base, stake 162 mates with opening 166. Heat is applied using a hot plate to the stake/opening to deform the plastic material using heat and force, holding the stake securely in position like a rivet. A bond is made by partially deforming the stake 162 around opening 166. Numerous other means of attachment other than heat staking are possible within the scope of the claims, including e.g., laser welding, ultrasonic welding, adhesion, mechanical clipping, and the like. Further, it should be noted that in alternative embodiments in which the lens support may be formed as part of the same unitary molded or printed component as the lever and/or the entire base. The point of coupling/attachment of the lens support to the lever is preferably about 2 to 5 mm from the pivot line to the front of the peg/stake. In many embodiments, such as the one illustrated in which the pivot line is formed by a fold in plastic or other substantially rigid material, the pivot line may have a thickness, i.e., it may not be perfectly sharp. In these cases, such separation may be needed between the point of attachment and the pivot line in order to maximize the lifting angle for a given bend force.

[0057] The underside of a lid 106, as can be seen in FIG. 2., includes multiple lens facing surfaces 168, which in this embodiment are formed as projections extending downward toward the lens's convex surface. The lens facing surfaces 168 are generally shaped to mirror the convex lens surface of the contact lens to be housed in the lid cavity 136. The lens facing surfaces 168 serve to align the contact lens over the lens support and to protect the contact lens against significant optical damage due to gravitational or air-induced forces. In some embodiments, lens facing surfaces also serve as air entry guides by guiding air entering the package over the contact lens to reduce the incidence of the contact lens sticking to the package upon opening. In this case, the lens facing surfaces are provided on a molded plastic lid insert 170, wherein the lid insert 170 is attached to an inner surface of the foil lid 106 by a heat seal. But in other embodiments, for example where the lid is substantially rigid, the lens facing surfaces may be integral to the lid rather than a separate component. It will be understood that all features described as being imparted upon a lid insert could be applied equally to embodiments in which the same features are made integral to the lid.

[0058] Lens facing surfaces of the present invention serve to support the lens when loaded by these forces to avoid or reduce significant optical damage. For example, gravitational forces and interactions with air bubbles in the packaging solution can result in optical damage if not properly counteracted. In one aspect, lens facing surfaces, as in the lens facing surfaces 168 of the illustrated embodiment, include a relatively large contactable surface area, at least about 3 percent and preferably at least about 20% of percent or as large as possible while still accommodating any desired air egress channels. The contactable surface area is understood to mean the area of contact between the lens and lens facing surfaces when the lens is loaded, i.e., placed into contact under an applied force, such as but not limited to gravity or air bubble interaction. The contactable surface area determines the pressure exerted on regions of the lens when/if it is loaded. The larger the area, the more the pressure is reduced. In the embodiment illustrated, the lens facing surfaces 168 have a contactable surface area of 100 mm.sup.2 conventional contact lens having a surface area of approximately 215 mm.sup.2. As discussed in more detail below, it is preferable that at least 10% of the surface area above the lens be left exposed to promote air entering the package to travel over to reduce any tendency of the lens to stick to the lens facing surfaces/lid insert.

[0059] The lens facing surfaces 168 are also spaced apart to define air egress channels 169 allow air, in particular air bubbles in the packaging solution, to travel away from the contact lens into a peripheral volume of the cavity 136. It is advantageous for the air egress channels have a positive gradient toward the peripheral volume with a vertical rise of at least about 2 mm. Air egress channels permit smaller air bubbles to escape from the area around the lens surface while simultaneously avoiding larger bubbles entering the space above the lens. Toward this end, preferred embodiments include at least two air egress channels each having a width of between about 1 mm-1.5 mm or preferably between 1.5 mm-2 mm and, specifically 1.5 mm in the embodiment illustrated. In a related aspect, air egress channels 169 advantageously form an “X” configuration. This configuration of air egress channel positions relative to each other allows, when the package is rotated in a side orientation, at least one of the channels always to have a central axis from near the center of the cavity that is angled relative a plane normal to gravity. This aspect exploits buoyancy to allow air bubbles to escape away from lens irrespective of the orientation the lens package take thus reducing the optical damage that might otherwise result, e.g., from the air bubble forcing the lens into the lens support.

[0060] Lid insert 170 is attached to an inner surface of the lid 106 in this embodiment by a heat seal between the multilayer film lid 106 and the planar surfaces 172a-d on the upper side of the lid insert. As discussed in more detail later herein, alignment of a lid insert with the base during the heat-sealing process and during storage may be aided by the inclusion of one or more alignment features in the base and/or lid insert. For example, alignment features 174 in the embodiment illustrated take the form of columns on the interior wall of cavity 136 of the base 110. The alignment features 174 resist rotation and lateral motion of the lid insert 170 when pressure is applied to seal the package 100 or during normal use. Alternative alignment features are possible such as but not limited to forming the cavity and lid insert (or integral portion of the lid comprising lens facing surfaces) in a non-circular shape such that the components interlock and resist rotation inherently.

[0061] Referring now to FIG. 4, illustrated is a close-up view of a lid insert 170 when inserted in cavity 132 of base 110. The position of alignment features (e.g., columns 174) on the wall of cavity 136 of the base 110 correspond to openings 178 in lid insert 170. Columns 174 and openings 178 cooperate as an assembly to restrict rotational and lateral movement of the lid insert 170. In another aspect, the lid insert may be configured to prevent the lens support from lifting (other than the expected time during opening) and to ensure that the lens is not compressed in the package due to external forces when sealing pressure is applied or during storage, transport, or when the user opens the package. For example, a lock-out feature may be included to prevent lid features, such as lens facing surfaces (whether integral to the lid or included on a lid insert) from impinging on the lens when pressure is applied overhead, such as when the lid is sealed to the base or when the lid insert, if any, is sealed to the lid. Other lock-out features may be included to stop the lens support from impinging into the lens (e.g. due to bending the pack at the pivot before it is open) by making a point of contact between the lens support and the lid insert. Further still, another lock-out feature in this embodiment is created by a ledge 180 along the perimeter of the floor of cavity 136. One function of the ledge 180 is to avoid a pinch point for the lens perimeter during assembly. The height of the ledge above the cavity floor is made sufficient so that the lid insert and/or lens facing features of the lid are stopped at a height above where the lens is housed beneath. In this embodiment, the ledge measures approximately 0.8 mm in height above the base of the lens. It should be understood that a ledge is yet another exemplary lockout feature of many possibilities. To be sure, the lid insert could be locked out at any level (e.g. level with the base of the lens, level with the top of the pack).

[0062] FIGS. 5A and 5B illustrate a cross-sectional view of a contact lens package 100 in an unopened state. Specifically, FIG. 5B illustrates the cross-section created across section plane AA indicated in the perspective side view in FIG. 5A. As shown, package 100 is configured such that when in an unopened state, contact lens 138 is substantially suspended between lens support 140 and lens facing surfaces 168. Packages of the invention preferably minimize contact with the contact lens when the package is closed, and the lens is suspended in packaging solution. Ideally, the optical zone of the lens is free floating and contact with the lens support during storage is transitory or non-existent. Depending on the buoyancy of the lens in the package solution and the orientation, the lens may rest on its peripheral edge on the floor of the cavity in the base of the package or on its convex surface on the lens facing surfaces. As illustrated, contact lens package 100 is in a lid-up orientation in which the peripheral edge of the contact lens rests on the floor of the cavity 136 in the base 110. However, the optical zone of the contact lens 138 is effectively suspended between the lens support 140 and the lens facing surfaces 168.

[0063] Cavity 132 preferably is substantially filled with packaging solution, provided however that manufacturing processes may not permit sealing the packaging under vacuum pressure. In such cases, it is anticipated that some amount of air will become entrapped in the cavity. If these air bubbles are not managed, they may interact with the lens and cause significant optical damage to the lens. Accordingly, peripheral volumes in the cavity, i.e., volumes in the cavity that are peripheral to the location of the lens over the lens support, may be provided. Ideally, such volumes should be provided at the distal and proximal ends of the package, such as 132′ and 132″ of cavity 132 of package 100, so that the air bubbles have a place to reside regardless of the orientation of the package during transport or storage.

[0064] In one aspect, lens facing surfaces may function as air entry guides through placement and configuration that causes air that enters the package upon opening to travel over the contact lens to avoid the contact lens sticking to the lid or lens facing surfaces thereof. As illustrated in FIG. 6, contact lens package 100 is depicted in an assembled, unopened state in which the foil lid is not shown so that the components as sited within package 100 may be seen in this embodiment, the package 100 is configured to be opened from proximal end (A) to distal end (B) such that air enters the package in the direction indicated by arrow 190. To ensure that air travels over the lens, lid insert 170 is configured so that the convex surface of the lens 138 is exposed above the lens edge closest to the point 192 that air enters the cavity upon opening. This may be achieved by positioning the lens facing surfaces predominantly over the lateral and distal surface areas of the contact lens and leaving exposed at least about 10% the surface area of the contact lens nearest point 192 where air enters the cavity. More specifically, in this embodiment, 15% of the contact lens's surface area is left exposed.

[0065] Lens supports of the present invention may take myriad shapes and forms capable of lifting the lens out of the packaging solution when the user applies force(s) to the package, such as squeezing the package as described with respect to embodiments herein. However, as mentioned it is preferable that the lens support keeps the lens in the desired convex orientation (bowl down relative to the base) and position (centered over the support) during shipping and storage. Ideally, the lens support may provide an open structure under the lens to allow, upon opening, the packaging solution to drain from the lens and support without trapping water between the support and the underside of the lens. It is also preferable that the lens support has a sufficient number of contact points with the lens to prevent the lens from collapsing onto, rotating off or translating across the support. This allows the apex of the lens to be supported by the lens's own elastic stiffness, or to minimize sinking of the lens apex while limiting the contact area between the support and lens. Too much contact between the support and the lens after solution draining, and water trapped between the support and the lens, can create surface tension between the lens and water on and around the lens support that is greater than the surface tension between a wearer's finger and the lens, interfering with efficient lens transfer.

[0066] The sum of the contact between the lens and the lens support when the package is open, and the solution drained from the lens and lens support is the total wetted contact area, which may be less than about 30 mm.sup.2, less than 25 mm.sup.2 or less than 20 mm.sup.2 and is distributed at least around the lens periphery, as described herein. “Wetted contact area” as used herein refers to the direct solid contact area between the lens support and the lens added to the area of any menisci, reservoirs, or solution bridges that form between the lens and lens after the lens is lifted and packaging solution is allowed to drain for less than about <30 s, less than about <5 s, or less than about 2 s, depending on the intended user experience of the package.

[0067] For lenses made from polymers with longer shape memory, the lens support may be designed to limit contact between the lens and support during storage. Such contact may be distributed around the lens peripheral edge. Contact between the lens optic zone, lens support and lid interior (including any air entry guides) may be transitory or there may be no contact between the optic zone and support, lid or air entry guides. Lenses, such as conventional hydrogels, having shorter shape memory, are less prone to distortion from packaging contact, and can have the contact points distributed around the periphery and throughout the lens profile, including the lens center zone (about 9 mm, or about 5 mm diameter).

[0068] The lens supports of the present invention preferably allow, upon dabbing, both the fingertip and lens to deform to match each other's shape, without causing lens inversion or damage to lens during removal from too much pressure during dabbing. Thus, an aspect of the removal of the lens from the present packages may be to control the ratio of the contact area between the finger and lens as compared to the area between the lens and the lens support so that the contact area between the finger and lens exceeds the contact surface area of the lens support on the lens underside. This will ensure that surface tension between finger and lens exceeds surface tension between lens and lens support. Thus, the lens will adhere to the finger for lens transfer and placement onto the eye.

[0069] The lens support preferably provides at least 2, at least 3, 3 to 14, 4 to 14, 3 to 8 or 4 to 8, 4 to 6 or 6 points of contact with the contact lens edge along the peripheral supports. When two peripheral supports are used, they may be wider to provide stability, without exceeding the area of contact desired for consistent lens transfer. The peripheral points of contact prevent the lens from rotating off the lens and can be distributed in a number of configurations, in which the space between the furthest adjacent contacts is less than the diameter of the lens. As the number of peripheral supports is increased the likelihood of residual packaging solution forming films between adjacent peripheral supports and solution bridging between the support and lens may be increased during drainage. Peripheral supports with less than 50% open space such as those in the form of a screen or strainer, generally provide insufficient drainage to insure one touch transfer. Likewise, too much contact between the support and the lens after solution draining, and water trapped between the support and the lens, can create surface tension between the lens and water on and around the lens support that is greater than the surface tension between a wearer's finger and the lens, interfering with efficient lens transfer. The width of the constituent support members of the lens support vary between the limits of the selected molding process and widths necessary for efficient packaging solution drainage upon opening. Suitable widths include about 0.5 to about 1.5 mm, about 0.5 to about 1, or about 0.5 to about 0.7 mm, and it will be appreciated that lens support designs having fewer contact points may have thicker arms.

[0070] Lens supports may achieve sufficient drainage of packaging solution from the lens to enable single-touch transfer through one or a combination of drainage techniques referred to herein as channel drainage and back drainage. Channel drainage involves the formation on the lens support of channel members along which packaging solution is channeled away from the lens under the force of gravity when the lens support is lifted. Back drainage, on the other hand, refers to enhanced drainage from the underside of the lens where the lens rests on the lens support. This area underneath the apex of the lens tends to trap packaging solution due to the hydrophilicity of modern contact lens materials. Enhanced back drainage may be achieved in some embodiments by designing the lens support with a central opening beneath the apex of the lens of at least about 12 mm.sup.3.

[0071] Referring then to FIGS. 7A and 7B, illustrated is exemplary lens support 140 in a side and a top view, respectively. Lens support 140 represents an example of a lens support that leverages a hybrid of back drainage and channel drainage to clear packaging solution from the lens sufficiently to enable single-touch transfer. Lens support 140 includes a central support composed of three central support members 200a-c in a semi-circular configuration having a diameter of approximately 8 mm. Central support members 200a-c are elevated 2.5 mm by pillars 204. Pillars 204 extend upward from channel members 204a and 204b, which transition along their length from proximal end (A) to distal end (B) to form a channel formation into a peripheral support 208. These members cooperate so that when the contact lens is lifted from the package, it rests upon lens support 240 in the preferred convex orientation (bowl down relative to the base of the package) at 7 contact points when the lens is lifted from the packaging solution.

[0072] The design of lens support 140 creates central opening 212 to allow the packaging solution to back drain from the lens and lens support 140 when the package is opened and the lens support lifted from the packaging solution. This allows the apex of the lens to be supported by the lens's own elastic stiffness, and to minimize sinking of the lens apex while limiting the contact area between the support 140 and lens. The design also provides sufficient support to edge of the contact less at points along the channel members 204a and 204b as well as along peripheral support 208. This configuration sufficiently reduces the wetted contact area between the lens support 140 and the contact lens to at least about 25 mm.sup.2 when measured 2 seconds after lens support 140 is lifted.

[0073] One of myriad alternative embodiments of a lens support within the scope of the invention is shown at FIGS. 8A and 8B illustrate in a side and a top view, respectively. Lens support 300 represents an example of a lens support that relies upon back drainage to clear packaging solution from the lens sufficiently to enable single-touch transfer. Lens support 300 includes a central support 310 composed of four equally spaced radial spokes extending across a diameter of approximately 10.5 mm. Central support members 310 is elevated 2.7 mm by pillars 314. Pillars 314 extend upward from support member 318, which includes a tab 324 by which the lens support 300 may be coupled to a base of a contact lens package in certain embodiments of the invention. Peripheral support members 328 and 330 are formed in a continuous bow-tie configuration to provide support to the edges of a contact lens when the lens is lifted from the package and resting upon the support. The central and peripheral support members of support 300 cooperate so that when the contact lens is lifted from the package, it rests upon lens support 300 in the preferred convex orientation (bowl down relative to the base of the package) at 5 contact points when the lens is lifted from the packaging solution.

[0074] The design of lens support 300 includes sufficient open space between the spokes of central support 310 to allow the packaging solution to back drain from the lens and lens support 140 when the package is opened and the lens support lifted from the packaging solution. This allows the apex of the lens to be supported by the lens's own elastic stiffness, and to minimize sinking of the lens apex while limiting the contact area between the support 300 and lens. The design also provides sufficient support to the edge of the contact lens at points along the peripheral support members 328 and 330. This configuration sufficiently reduces the wetted contact area between the lens support 300 and the contact lens to at least about 25 mm.sup.2 when measured 2 seconds after lens support 300 is lifted. It must be emphasized that the lens support embodiments illustrated and described herein are merely two among of myriad embodiments of a lens support within the scope of the invention as set forth in the appended claims. To be sure, a number of additional illustrative but non-limiting exemplary lens supports are depicted in FIGS. 11-25.

[0075] As noted above, in one aspect contact lens packages of the present invention may be configured to allow a nested configuration. FIG. 9 illustrates two of contact lens package 100 shown as packages 100′ and 100″ in a nested configuration. A nested configuration, such as the one depicted in which the packages fit together securely within a smaller volume are useful for reducing the amount of secondary packaging (e.g., carton or other container in which the primary packages are provided to the consumer). In this embodiment, packages 100′ and 100′ are designed to nest when arranged base-to-base and inverted relative to each other from proximal end to distal end. The ability of contact lens packages 100′ and 100″ to nest is enabled by a combination of features including: a taper in the base 110′ and 110″ of each package and finger engagement features (dimples) 122a′ and 122a″ functioning as stops against lateral movement of the bases 110′ and 110″.

[0076] Turning now to FIG. 10 are illustrated exemplary methods of manufacture/assembly of a contact lens package in accordance with an embodiment. A first exemplary method of manufacture/assembly of the exemplary contact lens package 100 is illustrated as steps 1001A, 1002A, 1003A, 1004A, and 1005. At a first step 1001A, a contact lens 138 is placed onto lens support 140 in this embodiment with the contact lens being placed onto the lens support 140 with its concave side of the contact lens onto the lens support. The lens support may be pre-dosed with packaging solution sufficient to cause the contact lens to bind to the support. In a slightly alternative approach not illustrated, the lens support may be inserted into the cavity first and the contact lens placed on the support thereafter. At a next step 1002A, lens support 140 with the contact lens 130 resting thereon is inserted into cavity 136 of a base 110. Then, at step 1003, lid insert 170 comprising lens facing surfaces 168 is placed onto the convex side of the contact lens 138. Next, at step 1003A, the cavity is dosed with packaging solution sufficiently to fully submerge contact lens 138 in the cavity and ideally as full as possible without overflowing the cavity. Preferably, at least one of the fitment and/or a surface feature of the lid insert against the base cavity creates a friction fit so that the lid insert does not float out of position when the packing solution is added to the cavity. Finally, at a step 1005, the lid 106 is sealed onto the base 110, for example by heat sealing the foil to the base as described in more detail above, such that the sealing encloses the contact lens 138 and packaging solution within the cavity 136 in a sterile environment.

[0077] An alternative exemplary method of manufacture/assembly of the exemplary contact lens package 100 is illustrated as steps 1001B, 1002B, 1003B, 1004B, and 1005. At a first step 1001B, a package base 110 is provided wherein a cavity 136 of the base 110 has lens support 140 coupled thereto. In this example, lens support 140 is coupled to the base by a heat staking process as described in more detail above. However, as noted, other means of attachment are possible within the scope of the claims, including e.g., laser welding, ultrasonic welding, adhesion, mechanical clipping, and the like. Next at a step 1002B, a contact lens 138 is placed onto a lens facing surface of a lid insert 170, in this embodiment with the lens's convex surface resting against the lens facing surfaces 168 of lid insert 170. The lens 138 may be placed onto the lid insert by manual or automated means such as through a lens transfer nozzle. Then, at a step 1003B, the lid insert 170 having the contact lens 138 resting thereon is placed onto the lens support 140 in the cavity 136 of the base 110. Next, at a step 1004B, the cavity 136 is dosed with packaging solution sufficiently to fully submerge the contact lens 138 in the 136 cavity and ideally as full as possible without overflowing the cavity. Finally, at a step 1005, the lid 106 is sealed onto the base 110, for example by heat sealing the foil to the base as described in more detail above, such that the sealing encloses the contact lens 138 and packaging solution within the cavity 136 in a sterile environment.

[0078] In some methods of manufacture/assembly of contact lens packages within the scope of the invention, the provision of packaging solution to the cavity may take place in multiple doses at different steps of the assembly process as opposed to all at once as described in the exemplary methods above. For example, in embodiments in which the lens is placed upon the lens support (e.g., step 1001A above) it may be advantageous to pre-dose a small amount of packaging solution onto lens support before resting the lens thereon so that the lens becomes secured to the lens under the surface tension of the solution. Dividing the dosing of packaging solution may also be advantageous when filling the cavity, such as, for example, by dividing a dose of approximately 2080 μL into two approximately equal sized doses for example at steps (1001B and 1004B) described above.

[0079] The foregoing description, for purposes of explanation, used specific nomenclature to provide a thorough understanding of the described embodiments. However, it will be apparent to one skilled in the art that many of the specific details are not required in order to practice the described embodiments. Thus, the foregoing descriptions of the specific embodiments described herein are presented for the purposes of illustration and description. They are not targeted to be exhaustive or to limit the embodiments to the precise forms disclosed. It will be apparent to one of ordinary skill in the art that many modifications and variations are possible in view of the above teachings.

[0080] The Summary and Abstract sections may set forth one or more but not all exemplary embodiments of the present invention as contemplated by the inventors, and thus, are not intended to limit the present invention and the appended claims in any way.

[0081] The foregoing description of the specific embodiments will so fully reveal the general nature of the invention that others can, by applying knowledge within the skill of the art, readily modify and/or adapt for various applications such specific embodiments, without undue experimentation, without departing from the general concept of the present invention. Therefore, such adaptations and modifications are intended to be within the meaning and range of equivalents of the disclosed embodiments, based on the teaching and guidance presented herein. It is to be understood that the phraseology or terminology herein is for the purpose of description and not of limitation, such that the terminology or phraseology of the present specification is to be interpreted by the skilled artisan in light of the teachings and guidance.

[0082] The packages of the present invention may be manufactured using known materials and processes. The packaging materials may be virgin, recycled or a combination thereof. The volume within the package cavity can vary depending on the design selected.

[0083] Not all the features described herein need to be incorporated into every package, and those of skill in the art, using the teachings herein, can combine the features to provide a wide variety of improved contact lens packages. In summary, the contact lens packages of the present invention incorporate several novel functionalities which may be combined in a wide variety of combinations as described herein to provide the desired improved and/or single touch packaging. The breadth and scope of the present invention should not be limited by any of the above-described exemplary embodiments but should be defined only in accordance with the following claims and their equivalents.