Contact lens package and lens support for use therein
Patent Information
- Authority / Receiving Office
- JP · JP
- Patent Type
- Applications
- Current Assignee / Owner
- Filing Date
- 2023-06-14
- Publication Date
- 2026-03-31
AI Technical Summary
Conventional contact lens packages require multiple touches to transfer the lens from the package to the eye, leading to contamination risks and mechanical stress on the lens.
A contact lens package designed for one-touch removal and placement, featuring a lens support and lever mechanism that allows the lens to be lifted and moved directly from the package to the eye without inversion or additional manipulation.
The package enables a consistent one-touch lens movement, reducing the risk of contamination and mechanical stress, while maintaining the lens in a sterile and hydrated state.
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Abstract
Description
Technical Field
[0001] In conventional contact lens packages, the contact lens is typically placed on a molded plastic base having a cavity (or "bowl") that houses the contact lens with the concave side facing up. As a result, the user experience for transferring the contact lens from the package to the eye generally involves the user "lifting" the contact lens out of the bowl with a finger and then inverting the lens to get it into the correct orientation on the finger for placement over the eye. This process requires multiple touches to the lens, which can transfer contaminants or pathogens from the hand to the lens and ultimately to the eye. This handling experience is not only unhygienic, but also overly cumbersome, tedious, and mechanically stressful to the lens, which can be torn, broken, or distorted when overly manipulated. Some packages are designed to present the lens in an orientation with the convex side up to eliminate the need to invert the lens, but often still require the lens to be "lifted" out of the package solution or otherwise manipulated and / or touched multiple times to achieve lens movement to the eye.
[0002] In view of the increasing awareness regarding eye health and the customers' demand for a more convenient experience, there is a need for a contact lens package that enables a less cumbersome and more hygienic contact lens handling process. In one aspect, it is desirable to provide a "one-touch" package, i.e., a package in which a contact lens wearer can remove the lens from the lens storage package with a single touch of one of the fingers and then, with this single touch, correctly position the lens on the eye. In such a design, there is no need to move and manipulate the lens from one finger to another before placing the lens on the eye. By providing such a one-touch package, not only is the lens preparation and insertion process streamlined, but also the likelihood of dropping the lens or exposing the lens to additional bacteria on the wearer's other fingers while the lens is being prepared for orientation and insertion onto the eye is reduced, as well as the likelihood of touching the side of the lens that is intended to contact the eye.
[0003] The design of a one-touch lens package faces several different challenges. The wearer should ideally be able to consistently position and attach the lens to the finger during removal from the package, and then the lens should be consistently released from the finger onto the eye. Contact lenses (both reusable and daily disposable types) each have their own unique surface, bulk, and geometric properties. The finger size and the force that a contact lens wearer applies to the lens during movement can also vary. These factors can affect the process of removing the lens from the package to the finger and then applying it onto the eye surface. Among other considerations, variations in the amount of package solution adhering to the lens and the package can affect the process of placing the lens on the finger, so it would be desirable for the wearer to be able to expel any package solution that could potentially affect the ability to attach the lens to the finger. Also, it would be desirable to expel the package solution in a controlled manner to avoid leakage. Also, it would be beneficial for the package solution to remain sterile and accessible to the wearer after opening to enable rewetting or cleaning of the lens. Also, the wearer may have concerns regarding the possibility of transferring external products such as bacteria or cosmetics to the contact lens, and of course, the manufacture of the package itself should conform to the expected industry standards recognized by the medical and commercial provider communities.
[0004] Furthermore, the one-touch package should ideally not result in an exorbitant increase in the cost of the article relative to current contact lens packages, as this could potentially lead to an increase in cost for the wearer population. The package should not make it difficult to hold the lens when removed from the package. Additionally, if the package configuration is for maintaining or even reducing the volume of solution required to package the lens, this would thereby reduce the ecological impact of the lens package. Similarly, it would be beneficial if all or part of the package could be made from recycled materials and / or be recyclable in whole or in part.
[0005] In addition, it would be advantageous if the package was already approved by various regulatory agencies and ideally was composed of materials that did not require changes to the chemistry of the solution or the lens composition. Optimally, moreover, the function of the package preferably does not incorporate any electronic devices or other electrical components if such components could adversely affect the performance of either the package or the lens.
[0006] There are several desirable attributes that make it difficult to achieve the function of a one-touch package and that are often lacking in known attempts to create a one-touch package. These attributes include, for example, the following: i) the package should ideally protect the lens, i.e., ensure the integrity of the lens (e.g., lens shape and optical integrity) while at the same time preventing the lens from being crushed or damaged, ii) the lens package should maintain the hydration of the lens when stored in order to maintain the lens's properties, and iii) the lens within the package should preferably be configured to be completely immersed in the package solution when desired and to remove such solution when ready to be removed from the package, iv) the package should generally have a retortable seal and contain both the lens and the solution, v) the package should preferably maintain the lens in the desired convex orientation with respect to the wearer, vi) the lens should be positioned so that it can be easily removed by the wearer, and vii) the package should ideally enable the effective drainage of the package solution from the lens prior to opening the package and removing the lens, allowing it to be more easily transferred to the wearer's finger and then onto the eye.
[0007] Known packages that have attempted to provide a reduced touch or one-touch orientation are unable to provide one or more of the above-desired attributes of a one-touch package. For example, International Publication Nos. WO 2014 / 195588, WO 2009 / 069265, and Japanese Patent No. 6339322 disclose packages that present a lens in a configuration with a convex bowl facing downward. Similarly, U.S. Patent Application Publication No. 2020 / 0229560 discloses a lens carrier that supports a concave (front or anterior) surface of a contact lens, or a grid that supports a contact lens periphery and allows package solution to be drained through the grid to a bottom chamber when the lens package is opened. However, these package designs create an excessive wet contact area between the lens and the lens support. Similarly, U.S. Patent No. 7,540,376 discloses a lens carrier having a rigid member under the apex of a contact lens, which impedes the user's ability to dab the lens. Thus, known packages may not support a desired convenient user experience; for example, they may not support a consistent one-touch movement of the lens. The foregoing deficiencies of the prior art are merely illustrative and not exhaustive. SUMMARY OF THE INVENTION PROBLEMS TO BE SOLVED BY THE INVENTION
[0008] Accordingly, there is still a need for a contact lens package that provides a consistent one-touch lens removal experience, effective solution management, or addresses one or a combination of the foregoing problems or deficiencies. MEANS FOR SOLVING THE PROBLEMS
[0009] In a contact lens package having one or more aspects described herein, it has now been found that some or all of the foregoing and related objectives can be achieved. BRIEF DESCRIPTION OF THE DRAWINGS
[0010] The foregoing and other features and advantages of the present invention will become apparent from the following more particular description of the preferred embodiments of the present invention, as illustrated in the accompanying drawings.
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[0011] Here, reference is made in detail to representative embodiments illustrated in the accompanying drawings, where reference numerals indicate specific elements. The following description is not intended to limit the countless embodiments to one preferred embodiment. In contrast, it is intended to cover alternatives, modifications, and equivalents that may be included within the spirit and scope of the described embodiments as defined by the appended claims.
[0012] References to "one embodiment," "an embodiment," "some embodiments," "an example embodiment," etc., indicate that the described embodiments may include a particular feature, structure, aspect, or characteristic, but not all embodiments necessarily include the particular feature, structure, or characteristic. Further, such phrases do not necessarily refer to the same embodiment. Further, when a particular feature, structure, aspect, or characteristic is described in relation to an embodiment, it is considered within the knowledge of those skilled in the art to implement such feature, structure, or characteristic in relation to other embodiments, whether or not explicitly described.
[0013] As used herein, the following terms have the following meanings. The advantages of certain embodiments of the present invention are that they facilitate a consistent one-touch lens movement from the package to the wearer's finger and then from the finger to the wearer's eye without inverting the lens, dropping it from the finger, or without further manipulation. A consistent one-touch lens movement includes a movement rate of at least about 70%, at least about 80%, or at least about 90% of the movement relative to the first touch (or "dab") of the finger. The lens also preferably "pops up" onto the finger and then moves to the eye when placed on the eye without being folded or inverted. The package of certain embodiments can provide the desired one-touch lens movement over a range of finger sizes and dab pressures. Environmental conditions such as temperature and whether the finger is wet or dry can also affect the movement rate, and generally, higher temperatures improve lens movement.
[0014] The lens(es) or contact lens(es) refer to ophthalmic devices that are present on the eye. They generally have a hemispherical shape and can provide optical correction, cosmetic enhancement, UV shielding and visible light or glare reduction, wound healing, therapeutic effects including drug or nutraceutical delivery, diagnostic evaluation or monitoring, or any combination thereof. The term lens generally includes soft hydrogel contact lenses that are provided to the consumer in a hydrated state and have a relatively low modulus of elasticity that allows them to conform to the cornea. Contact lenses suitable for use with the package of the present invention include all hydrated contact lenses, including conventional hydrogel contact lenses and silicone hydrogel contact lenses.
[0015] A hydrogel is a hydrated cross-linked polymer system that contains water in an equilibrium state and can contain at least about 25% or at least 35% water in the hydrated state. Hydrogels are typically oxygen permeable and biocompatible and are excellent materials for the manufacture of contact lenses.
[0016] Conventional hydrogel contact lenses do not contain a silicone-containing component and generally have a higher water content, lower oxygen permeability, elastic modulus, and shape memory than silicone hydrogels. Conventional hydrogels are prepared from monomer mixtures mainly containing hydrophilic monomers such as 2-hydroxyethyl methacrylate ("HEMA"), N-vinylpyrrolidone ("NVP"), or polyvinyl alcohol. U.S. Patent Nos. 4,495,313, 4,889,664, and 5,039,459 disclose formations of conventional hydrogels. Conventional hydrogels can be ionic or nonionic and include polymacon, etafilcon, nelfilcon, ocufilcon, lenefilcon, etc. The oxygen permeability of these conventional hydrogel materials is typically less than 20 to 30 barrers.
[0017] Examples of silicone hydrogel formulations include balafilcon, samfilcon, lotrafilcon A and B, delfilcon, galyfilcon, senofilcon A, B and C, narafilcon, comfilcon, formofilcon, riofilcon, fanfilcon, stenfilcon, somofilcon, kalifilcon, etc. "Silicone hydrogel" refers to a polymer network made from at least one hydrophilic component and at least one silicone-containing component. Silicone hydrogels can have a modulus of elasticity in the range of 60 - 200, 60 - 150, or 80 - 130 psi and a water content in the range of 20 - 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 variations thereof), in addition to U.S. Patent 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,Silicone hydrogels prepared as in U.S. Pat. Nos. 6,310,631, 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, 9,156,934, 9,170,349, 9,244,196, 9,244,197, 9,260,544, 9,297,928, 9,297,929, as well as International Publications Nos. WO 03 / 22321, WO 2008 / 061992, and U.S. Patent Application Publication No. 2010 / 0048847 are included. These patents are hereby incorporated by reference in their entirety. Silicone hydrogels can have a higher shape memory than conventional contact lenses.,
[0018] The hydrogel lens is a viscoelastic material. A contact lens may form optical distortion when the lens interacts with either the package or any air bubbles within the package. The degree of optical distortion and the length of time required for the distortion to relax vary according to the chemical properties and to a lesser extent according to the geometric shape of the lens. Conventional lens materials such as polyhydroxyethyl methacrylate-based lenses like etafilcon A or polymacon have a lower loss modulus and tan delta compared to silicone hydrogels and may form less and less severe optical distortion as a result of contact with the package. Incorporation of silicone (which generally increases the bulk elastic response), wetting agents such as PVP (which generally increases the viscous response), or coating of conventional hydrogel materials (which may decrease the elastic response at the lens interface) can change the viscoelastic properties of the lens. Conventional hydrogel contact lenses and silicone hydrogel contact lenses having short or rigid crosslinking agents and / or curing agents may have short shape memory and may be less susceptible to the effects of deformation during storage. As used herein, a hydrogel with high or higher shape memory exhibits at least about 0.18 optical distortion after 5 weeks of accelerated aging at 55° C. from contact with air bubbles or the package. Viscoelastic properties including loss modulus and tan delta can be measured using dynamic mechanical analysis.
[0019] The contact lens can be of any geometric shape or power, generally has a hemispherical shape, and has a concave posterior surface that is stationary relative to the eye during use and a convex anterior surface that faces away from the eye and contacts the eyelid during a blink.
[0020] The center or apex of the lens is the center of the lens optical zone. The optical zone provides optical correction and may have a diameter of from about 7 mm to about 10 mm. The lens periphery or lens edge is the edge where the anterior and posterior surfaces meet.
[0021] The wet lens is the contact lens and any residual package solution adhering thereto after drainage of the package solution.
[0022] An embodiment may include a lens support surrounded by a sealable cavity, also referred to interchangeably as a chamber. The cavity may have any convenient form and may comprise a package base and at least a lid, each of which will be described in detail below. As used herein, the terms "the lid", "a lid", "the base", and "a base" include both the singular and plural forms. The lid and the package base are sealed to each other to form a cavity that holds the contact lens, the support, and the package solution in a sterile state during transportation and storage prior to use. The contact lens package is compatible with the contact lens and the solution and is further made of a retortable and biologically inert material.
[0023] A "film" or "multilayer film" is a film used to seal a package and is often referred to as a lidstock. The multilayer films used in conventional contact lens packages can be used in the packages of the present invention as the base, lid components, or both. The multilayer film includes a barrier layer containing a foil layer or a coating, and a plurality of layers including a sealing layer that seals the film to the rest of the package, and may also include additional layers selected from a peel initiation layer, a lamination layer, and other layers that improve package properties such as rigidity, heat resistance, printability, puncture resistance, and barrier resistance to water or oxygen. The multilayer film forms a steam-sterilizable (retortable) seal. The multilayer film can include a PET, BON, or OPP film layer to increase rigidity and heat resistance, or an EVOH or PVDC coating to improve barrier resistance to oxygen or water vapor.
[0024] As used herein, "unsealed state" or "unsealed" refers to a contact lens package that is closed and contains the contact lens in a solution.
[0025] As used herein, "opened state" or "opened" refers to a contact lens package after the sterilization seal has been breached. Depending on the context described herein, the opened state extends to the state of the package when the user manipulates the package to lift and move the lens from the package solution.
[0026] As used herein, "wearer" or "user" refers to the person who opens the contact lens package. The user is generally considered to be the person who opens the package and moves the contact lens contained therein to that person's eye. However, in some contexts, the user can be a person who handles the lens package on behalf of the wearer, such as an eye care provider ("ECP") or another individual who demonstrates for or assists the wearer.
[0027] The package solution is any physiologically compatible solution that is compatible with the selected lens material and the package. The package solution includes buffered solutions having a physiological pH, such as buffered saline aqueous solutions. The package solution can contain known components including buffers, pH and elasticity modifiers, lubricants, wetting agents, nutritional supplements, pharmaceuticals, package coating components, and the like.
[0028] The package base can form the bottom of the package. It can be made from any material suitable for packaging medical devices, including polymers. The bowl polymer material can be injection molded, have a shelf life of at least 1 year, 2 years, or 5 years, and be any polymer material that provides a contact lens package compatible with the chemical and physical properties of the lens, the packaging solution, and any additives that may be included therein. The bowl polymer material can be selected from any of the aforementioned materials. The bowl polymer material can preferably be polypropylene, COP, COC, or a blend of polypropylene blended with COP or COC having a melting temperature higher than about 145°C. Examples of polypropylene include metallocene catalyst polypropylene polymers and copolymers, Ziegler-Natta catalyst polypropylene polymers and copolymers. Examples of suitable grades of polypropylene include ACHIEVE 1605 (metallocene catalyst PP homopolymer) and PP1264E1 (PP homopolymer, MFR = 20 g / 10 min) manufactured by ExxonMobil, Braskem CP360H (homopolymer), F350 HC2 (high crystallinity homopolymer, MFR = 35) manufactured by Braskem, Borealis RF366MO (random copolymer with nucleating agent and antistatic agent), BJ380MO (heterophasic copolymer with controlled rheology having nucleating agent and antistatic agent) manufactured by Borealis, Moplen HE649T (homopolymer) and HP301R (homopolymer) manufactured by LyondellBasell, SABIC 512A (controlled rheology PP homopolymer), Formolene 4111T and Formelene 4142T manufactured by Formosa Plastics, FHR 11T55V, FHR P4C5N-046, FHR P4C6N-041 manufactured by Flint Hills Resources, and Total MR2001 (homopolymer material), Total M3766 (metallocene catalyst PP homopolymer), and Total PPH10099 (controlled rheology PP homopolymer) manufactured by Total Petrochemicals.Polypropylene may have a melt flow range of from about 15 g / 10 min to about 44 g / 10 min as determined by ASTM D - 1238 - 10, "Standard Test Method for Melt Flow Rates of Thermoplastics by Extrusion Plastometer" or similar known methods. The polypropylene may be pure or may have undergone a controlled rheology process to increase its melt flow rate.
[0029] The package lid is generally present in the upper portion of the package and seals the base to form a cavity that houses at least a portion of the lens support, the lens, and the package solution. The lid can be made from any material suitable for packaging medical devices, including a foil or plastic formed sheet, a laminated film, or plastic. A package including plastic for one structure and a foil or laminated film as the other, or a package including a foil or laminated film as the outer layer of the lid and the base, are known in the art and are examples of suitable combinations.
[0030] References throughout this description to the injection molding process and the use of materials conventionally applied to injection molding are to be understood as illustrative. Those skilled in the art will understand that other manufacturing means, including but not limited to alternative molding processes, thermoforming, 3D printing, etc., are possible within the scope of the appended claims. Similarly, references to heat sealing and heat sealing are illustrative of the embodiments described herein. Other means of securing package components will be apparent to those skilled in the art, including the use of adhesives, glues, heat adhesion, welding such as heat, ultrasonic, or laser welding, or mechanical traps.
[0031] Certain aspects of the present invention can help reduce or prevent significant optical damage to a contact lens resulting from interactions with the interior of a bubble or lens package that can occur during storage or transportation due to gravity or other forces, such as mechanical pressure applied from outside the package. As used herein, significant optical damage means a root mean square (RMS) value of about 0.08 μm or greater.
[0032] Referring to the drawings, FIG. 1A illustrates an exemplary contact lens package according to one embodiment, and FIGS. 1B - 1D illustrate steps of handling a contact lens package 100 that houses a contact lens 138 in a package solution (not shown) 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 in FIG. 1A. In this embodiment, the lid 106 is a multilayer film, also referred to herein as a foil, and the base 110 is composed of a thermoplastic polymer such as polypropylene plastic. In this embodiment, the lid 106 takes the form of a relatively flexible material (i.e., a multilayer film), and the base 110 takes the form of a relatively rigid material, but it should be understood that other embodiments may include substantially rigid components for both the lid and the base. For example, in some embodiments, both the base and the lid may be made of polypropylene plastic or other relatively rigid materials. The base 110 includes a pivotal line 114 that allows a portion of the base forming the lever 118 to pivot when a force is applied to the lever 118. In this embodiment, the force applied to operate the lever 118 can include a simultaneous downward moment and a lateral moment.
[0033] The base 110 further includes several optional finger engagement features 122a and 122b to assist the user in handling the contact lens package during the opening process. The finger dimples 122a can be sized to correspond to the user's finger or thumb and are disposed at the proximal end of the base 110 with respect to the user. The foot 122b is at the distal end of the base 110. The finger dimples 122a in this embodiment are also angled downward such that pressure having one or both of a force, e.g., a downward moment and a lateral moment applied by the user's thumb, causes the lever 118 to hinge downwardly about the pivot line 114. The foot 122b, the foot 122b provides a large area for placing a finger or thumb and facilitates the application of the reaction force necessary to hinge the lever. The package 100 in this embodiment is further configured with a profile that slopes from the proximal to the distal end to further promote a downward moment on the lever, e.g., when the lever is being pushed down by the user or when the package is being squeezed, i.e., when the user applies pressure by hand at opposite ends of the package, i.e., by finger at one end and thumb at the other. In this embodiment, the package 100 is configured such that squeezing forces are applied to the distal and proximal ends. This design also allows the package to be pushed against a solid surface (e.g., a countertop) to actuate the lever 118. However, alternative embodiments are possible where opposing forces associated with squeezing are applied to one or more opposing ends of the package, such as, but not limited to, the sides, left, and right, or portions thereof, of the package.
[0034] In the first step shown in FIG. 1B, the user holds the unopened contact lens package 100 by its base 110. The user's grip on the package 100 can be improved by one or more finger engagement features 122a and b that are arranged and configured to provide a more stable grip on the package and / or assist in applying a force to lift the contact lens contained in the package to present it to the user and move it to the user's eye in a later step. Finger dimples 106 (seen in FIG. 1A) are positioned on the lever 118 of the base 110 and sized for the user's thumb 126 to grip the package. At the opposite end of the package 100, the user can grip the package as shown by positioning a finger firmly under the overhang 122b (seen in FIG. 1A) at the end of the base 110. In the case of a foot feature such as 122b, the surface area forming the foot can be curved or flattened to provide an increased area that can supply an opposing force when the package is being squeezed. Next, the user can open the package by unsealing the lid 106, which in this embodiment involves the user peeling the foil 106 from the proximal end to the distal end of the base 110 in the direction indicated by arrow 134, thus breaking the sterile seal between the foil (lid) 106 and the base 110. Although not essential, in this preferred embodiment, the package is optimized for the user to hold the base with one hand and peel and open the lid 106 with the other hand.
[0035] As illustrated in the steps shown in FIG. 1C, the package lid 106 is opened either by completely removing the lid as shown in the illustrative figure or alternatively by a partial removal sufficient to substantially expose the lens cavity 136 that houses the contact lens 138 in a package solution (not illustrated) on the lens support 140. With the package 100 in the opened state, the user then applies a force 142 to the lever 118. In this embodiment, the package is squeezed by the user, thereby supplying the forces 142 and 146 with the user's hand or hands opposing the proximal and distal ends of the package respectively, thereby causing the lever 118 to generate a greater moment. Optionally, the lever 118 can lock in place when the lens support 140 is raised to a predetermined lift angle, also referred to as the "lift angle", i.e., the angle at which the package is configured to present the lens to the user on the lens support relative to the horizontal plane defined by the lid. As will be described in more detail below with reference to FIGS. 2, 6, 7A, and 7B, the operation of the locking lever and / or lens support at a particular lift angle can be achieved by one or more locking mechanisms provided on the base of the package. The act of "locking" via the locking mechanism means that when the lens support reaches the predetermined lift angle, the lens support can hold its position in place without the user having to continue to apply a force.
[0036] Referring to FIG. 1D, at this stage, the force applied by the user to the lever causes the lens support 140 to lift the contact lens 138 out of the packaging solution (not illustrated). Ideally, the lens support lifts the contact lens high enough so that the lens faces the user without adhering the packaging solution, and thus is visible and movable from the support, but not so high that the lens slides off the support under gravity. This can be achieved by a lifting angle 150 of about 15° to 60° with respect to the horizontal plane defining the top of the base. The lens support is preferably configured so that when lifted in this way, as in the exemplary embodiment illustrated, the packaging solution is sufficiently drained from the contact lens to enable one-touch lens movement by the user. The user moves the contact lens 138 from the lens support 140 by tapping (also interchangeably referred to as "dabbing") the convex surface of the contact lens 138 and thereby releasing the contact lens from the lens support 138 and attaching it to the user's finger 154.
[0037] In this embodiment, the contact lens 138 is presented to the wearer in a convex orientation, meaning that the convex side of the lens is accessible to the wearer without the need to reorient the lens before placing the concave side of the lens 138 on the surface of the wearer's eye. However, it will be understood that other orientations, such as the concave orientation of a conventional blister package, are possible within the scope of the present invention. The movement of the contact lens 138 from the lens support 140 can be effected either by the wearer's finger 154 touching the lens directly or indirectly via an applicator film or other cover applied to the finger (such as that described in U.S. Patent Application Publication No. 20190046353), or by another means of movement such as a manual or automatic applicator device or tool. When moving the contact lens 138 from the package 100, the lens is placed on the finger 154 (or other means of movement) with the convex side of the contact lens 138 in contact with the finger 154 and the concave side of the lens 138 oriented for direct application to the surface of the user's eye, as shown in the illustrative steps. While one-touch / dabbing of the lens is the preferred mode of lens movement, it should be noted that conventional "pinching" of the lens from the lens support is possible.
[0038] Referring now to FIGS. 2 and 3, FIG. 2 illustrates a perspective view of an open contact lens package 100 in which a lens support 140 lifts a contact lens 138 out of a packaging solution (not illustrated). FIG. 3 illustrates an exploded perspective view of the contact lens package 100. The contact lens package 100 includes a base 110 having a proximal end (A) and a distal end (B). The base 110 includes a cavity 136 that houses the contact lens 138 in a packaging solution, and a lever 118 configured to pivot along a pivot line 114 of the base when a force is applied to the lever 118. In this embodiment, the lever 118 is formed as part of an integral component that forms the base 110. More specifically, the base 110 that includes the lever 118 is formed as an integral injection molded polypropylene plastic part. Alternative materials and processes for forming the base, including thermoforming and 3D printing (using materials such as ABS, PLA, HIPS, PETG, nylon, or others), will be understood by those skilled in the art. Preferably, the material used for the base is relatively rigid and has a glass transition temperature (T g) is provided. In this embodiment, the pivot line 114 is in a linear configuration along a horizontal axis about which the lever 118 hinges and is defined by a thin, folded region within the base. This thinning region provides sufficient relaxation along the line of the base material to allow the lever 118 to hinge to a desired position when a force is applied to the lever by the user. The use of one or more thinning regions is merely one of the countless ways in which a pivot line can be defined within the scope of the present invention. For example, in other embodiments where the lever is formed of the same material as the rest of the base, the material can be shaped to be thinner along the pivot line by laterally creasing the plastic at the desired location, and / or by imparting the pivot line to the base material by cutting, etching, or another method. Alternatively or additionally, one or more voids can be imparted to the base along the intended pivot line to facilitate bending of the plastic material along the intended axis. Further, in embodiments where the lever takes the form of a separate component, the pivot line can simply represent a horizontal interface between the lever and the rest of the base. In such embodiments, the hinging action along the pivot line can be provided by a hinge component, a rotatable interlock attachment, etc. It should be understood that alternative embodiments where the lever is a separate component coupled to the rest of the base by attachment means are possible within the scope of the present invention. For example, the lever can be formed as a separate injection molded part and then attached to the separately molded (or printed, etc.) portion that forms the rest of the base via a number of attachment means including laser welding, ultrasonic welding, adhesives, mechanical attachment, heat staking, etc.
[0039] The underside of the base may be inclined, as in the illustrated embodiment, to allow the packages to be "nested", thereby reducing the amount of package solution necessary to hydrate and hold the primary package material and the contact lens, and allowing for a more compact secondary package during storage and transport. In this example, the base 110 is inclined from the proximal end (A) to the distal end (B) at an angle of about 10°, and has a footprint of approximately 29 mm in width, 44 mm in length, and 12 mm in height. The preferred inclination ranges from about 0 to 20°, although the inclination may be made steeper, for example, from about 20 to 30°, as desired. The base includes a well, i.e., a cavity 136, formed in a tapered region where the contact lens 138 and the lens support 140 are housed when the package 100 is unopened. In this embodiment, the cavity has a volume of about 2240 μl, into which about 2080 μL of package solution is introduced, sufficient to completely immerse the contact lens 138 within the cavity 136. The foil lid 106 is secured to the base 110 via a retortable seal formed between beads 152 on the upper surface of the base surrounding the cavity 136. This seal may be formed by well-known heat-sealing techniques and associated apparatus.
[0040] The finger engagement feature (dimple) 122a is sized to correspond to the user's finger or thumb and is disposed at the end of the base 110 proximal to the user. The finger dimple 122a in this embodiment is also angled downward such that a force, e.g., pressure applied by the user's thumb, causes the lever 118 to hinge downward about the pivot line 114. The position of the dimple of this dimple and the position of the user's finger relative to the pivot line affect the amount of squeezing force necessary to hinge the lever along the pivot line. In this example, the dimple depth below the pivot line is 4.9 mm when measured from the seal level to the base of the dimple. The horizontal distance between the dimple and the hinge line affects the lever force required to bend the hinge. In this example, the end of the lever 118 is 14.5 mm from the pivot line 114.
[0041] The lens support 140 is coupled to the lever 118, such that the force applied to the lever 118 causes the lens support 140 to lift the contact lens 138 out of the packaging solution. In the illustrated embodiment, the lens support 140 is a separately formed (or printed) component fixedly attached to a portion of the base lever 118. The attachment is here effected via laser welding, whereby the tab portion 163 is welded to a corresponding recessed area 164 within the base 110. A number of other attachment means other than laser welding, including for example ultrasonic or RF welding, adhesion, mechanical clipping, thermal caulking, etc., are possible within the scope of the claims. Further, it should be noted that in alternative embodiments, the lens support may be formed as part of the same one-piece molded or printed component as the lever and / or the base as a whole. In many embodiments, such as the illustrated one where the pivot line is formed by a crease in plastic or other substantially rigid material, the pivot line may have a thickness, i.e., may not be perfectly sharp. In these cases, such a separation may be required between the attachment point and the pivot line in order to maximize the lifting angle for a given squeezing force. As will be discussed in more detail below with reference to FIGS. 6 and 7A and 7B, the package 100 also includes a locking mechanism (159a and 159b in this example) that locks the lever 118 in a predetermined position when the lens support 140 reaches a lifting angle that is high enough to allow sufficient drainage of the packaging solution from the lens 138, but not so high that the lens 138 slips off the lens support.
[0042] As can be seen in FIG. 2, the underside of the lid 106 includes a lid insert 170 having a surface 168 facing a plurality of lenses, and these surfaces are formed as protrusions extending downwardly towards the convex upper surfaces of the lenses 138 in this embodiment. The surface 168 facing the lenses is generally formed to reflect the convex lens surfaces of the contact lenses received in the lid cavity 136. The surface 168 facing the lenses functions to align the contact lenses on the lens support, prevent the lenses from bending or warping, and protect the contact lenses from significant optical damage due to gravity or air-induced forces. In some embodiments, the lens-facing surface also functions as an air inlet guide by guiding the air entering the package over the contact lenses to reduce the incidence of the contact lenses sticking to the package upon opening. In this case, the surface facing the lenses is provided on a molded plastic lid insert 170, and the lid insert 170 is attached to the inner surface of the foil lid 106 by heat sealing along heat seal surfaces 172a - d, and the heat seal surfaces are distributed and positioned to avoid shearing of the lid insert 170 when the user opens the multi-foil film forming the lid 106. However, in other embodiments, for example, when the lid is substantially rigid, the surface facing the lenses can be integral with the lid rather than a separate component. It will be understood that all features described as being imparted to the lid insert can equally apply to embodiments where the same features are integrated with the lid.
[0043] The surface facing the lens of the present invention functions to support the lens when loaded by a force in order to avoid or reduce significant optical damage. For example, gravity and interaction with air bubbles in the packaging solution can cause optical damage if not properly suppressed. In one aspect, a surface facing the lens, such as surface 168 of the illustrated embodiment, preferably includes a relatively large contactable surface area of at least about 20 percent, or as large as possible, while still accommodating any desired air outflow channels. The contactable surface area is understood to mean the contact area between the lens and the lens-facing surface when the lens is placed in contact under an applied force, such as but not limited to gravity or bubble interaction, with a load applied to the lens. The contactable surface area determines the pressure applied to the area of the lens when a load is applied to the lens. The larger the area, the lower the pressure. In the illustrated embodiment, the surface 168 facing the lens has a contactable surface area of about 40 percent of the convex surface area of the lens 138, and more precisely, about 215 mm 2 The surface area of a conventional contact lens having a surface area of is about 90 mm 2 . As will be discussed in more detail below, it is preferred that at least 10% of the surface area above the lens remains exposed to facilitate the movement of air entering the package between the surface facing the lens and the lens, reducing any tendency for the lens to stick to the surface / lid insert facing the lens.
[0044] The surface 168 facing the lens is also spaced apart so as to define an air discharge channel 169, allowing air, particularly air bubbles in the package solution, to move away from the contact lens and into the cavity 136. The spacing also allows the lid structure to bend when the foil lid is peeled off, thus avoiding the lid structure scraping and damaging the lens. The air discharge channel allows smaller air bubbles to escape from the area around the lens surface while simultaneously preventing larger air bubbles from entering the space above the lens. For this purpose, a preferred embodiment includes at least two air discharge channels each having a width of about 1 mm to 2 mm, or preferably 1 mm to 1.5 mm, specifically 1.1 mm in the illustrated embodiment.
[0045] In this embodiment, the lid insert 170 is attached to the inner surface of the lid 106 by heat sealing between the multi-layer film lid 106 and the upper planes 172a-d of the lid insert. As will be discussed in more detail later herein, alignment of the lid insert with the base during the heat sealing process and during storage can be assisted by including one or more alignment features on the base and / or the lid insert. For example, the alignment features in the illustrated embodiment take the form of a protrusion 174 on the lid insert 170 and a protrusion 176 within the cavity 136 of the base 110. The protrusion 174 resists rotation and lateral movement of the lid insert 170 in cooperation with the ledge 176 when pressure is applied to seal the package 100 or during normal use.
[0046] Referring now to FIG. 4, an enlarged view of the lid insert 170 is illustrated. The positions of the protrusions 174a and 174b of the lid insert 170 correspond to the ledge 180 of the base 110. The protrusions 174a and 174b and the ledge 180 cooperate as an assembly to limit the rotation and lateral movement of the lid insert 170, prevent the lens support from lifting (except during the expected time of opening), and ensure that the lens is not compressed within the package due to external forces during assembly, storage, transportation, or when heat seal pressure is applied when the user opens the package. In this sense, the protrusions 174a and 174b and the ledge 180 also function as a lockout feature to prevent lid features such as the surface 168 facing the lens (whether integrated into the lid or included on the lid insert) from colliding with the lens when pressure is applied overhead, such as when the lid is sealed to the base or when the lid insert (if present) is sealed to the lid. Other lockout features may be included to prevent the lens support from colliding with the lens by creating a contact point between the lens support and the lid insert (e.g., due to bending the package at the pivot axis before opening). One function of the ledge 180 is to avoid pinch points around the lens during assembly. The height of the ledge above the cavity floor is made sufficient so that the lid insert of the lid and / or the feature facing the lens is stopped at a height above where the lens is housed below. It should be understood that the protrusions and / or ledges are yet another exemplary lockout feature among many possibilities. To ensure this, the lid insert can be locked out at any level (e.g., the level with the base of the lens, the level with the top of the package).
[0047] FIG. 5 illustrates a cross-sectional view of the contact lens package 100 in an unopened state. Specifically, FIG. 5 illustrates a cross-section formed across a longitudinally extending cut along the center of the package 100. As shown, the package 100 is configured such that when in the unopened state, the contact lens 138 is housed between the lens support 140 and the lens-facing surface 168. The package of the present invention preferably minimizes contact with the contact lens when the package is closed, and the lens substantially floats in the package solution. Ideally, the optical zone of the lens floats freely and contact with the lens support during storage is either temporary or non-existent. Depending on the buoyancy and orientation of the lens in the package solution, the lens may be present on its peripheral edge on the floor of the cavity of the base of the package or on its convex surface on the lens-facing surface. As illustrated, the contact lens package 100 is in an orientation with the lid up, where the peripheral edge of the contact lens is on the floor of the cavity 136 in the base 110.
[0048] The cavity 136 is preferably substantially filled with the package solution, but there is a condition that the manufacturing process may not allow the package to be sealed under vacuum pressure. In such a case, some amount of air is expected to be trapped within the cavity 136. If these air bubbles are not managed, they can interact with the lens and cause significant optical damage to the lens. Accordingly, a peripheral volume within the cavity, i.e., the volume within the cavity around the position of the lens above the lens support, may be provided. Ideally, such a volume should be provided at the distal and proximal ends of the package, such as 139a and 139b of the cavity 136 of the package 100, so that the air bubbles have a place to exist regardless of the orientation of the package during transportation or storage.
[0049] The base 110 of the package 100 also includes a central dimple 184 provided under the lens 138. The central dimple 184 is, in this example, dome-shaped so as to generally follow the concave side surface of the lens 138 to provide additional support under the lens 138. The central dimple 184 also serves to reduce the amount of package solution required for the package and to reduce the amount of headspace, i.e., the amount of space where air bubbles may be located and exert a force that can cause optical damage to the lens 138.
[0050] Referring to FIG. 6, the contact lens package 100 is illustrated in an open state, and the lens 138 is lifted from the package solution at a position for movement by the user. The angle at which the lens emerges from the package solution is defined herein as the "emergence angle" (β) (not illustrated), which affects the manner and degree of outflow of the package solution from the lens, and thus can affect the possibility of consistent one-touch lens movement. When the user activates the lever 118 to lift the lens, it is observed that it is advantageous to configure the lens support 138 with respect to the base 110 and the lever 118 such that the upper side of the lens (i.e., the upper side when the lens is in the lifted position), i.e., 138' of the lens 138, emerges from the package solution in front of the lower side 138''. Ideally, the package should be configured such that this sequence (i.e., the upper side emerges first) remains correct within the range (10 degrees forward or backward) expected when the user opens the package, regardless of whether the user tilts the package towards or away from themselves. When the lens emerges from the packaging solution, it is observed that the film of the package solution remains intact on the lens support through the lifting movement. By causing the upper side 138' to emerge first, there is a bulk flow of fluid from the distal end of the lens 138' to the proximal end of the lens 138''. This causes the package solution to be facilitated to continuously drain, in some embodiments, through the discharge channel of the lens support (as will be discussed in more detail with respect to FIGS. 8A and 8B below), along a path maintained along the lens support 138. Conversely, if the lower side emerges in front of the upper side, the film of the package solution becomes more prone to breakage before the fluid has a chance to be discharged, and as a result, the package solution is more likely to be left behind between the lens and the lens support, thus preventing consistent one-touch movement.
[0051] The emergence angle is a function of at least two aspects of the lens support, namely the lever length and the primary lens angle. The "lever length" (L) is defined as the distance between the pivot point 114 and the vertex of the lens when the lens support is centered. The "primary lens angle" (θ) is defined as the angle of the lens within the cavity relative to the plane defined by the lid when the package is unopened. Table 1 below shows the range of values of the emergence lens angle generated by various combinations of lever lengths in the range of 11 mm to 16 mm and primary lens angles in the range of -4° to 20°.
[0052]
Table 1
[0053] An emergence angle greater than 0 degrees can support consistent movement, but an emergence angle of at least about 5 degrees, preferably 10 degrees, is observed to allow the pack to be tilted slightly from the user without interfering with the desired discharge effect. Lower emergence angles can allow for consistent one-touch lens movement but do not provide tolerance to pack tilt. Package 100 is configured such that the lens support 140 has a lever length L of 13 mm and a primary angle (θ) of 10 degrees, which produces an emergence angle of approximately 10 degrees. However, as stated, an infinite number of combinations of lever length and primary angle can produce an infinite number of acceptable emergence angles, including but not limited to those listed in Table 1.
[0054] Package 100 is also configured with a locking mechanism (described in more detail with reference to FIGS. 7A and 7B) that locks the lens support 140 at a lifting angle (α) of about 60 degrees (i.e., the angle at which the package is configured to present the lens 138 to the user on the lens support 140 relative to the horizontal plane 190). The lifting angle is preferably between about 45 and 75 degrees, and ideally, understanding that the maximum angle possible until the lens slides off the support depends on the particular design of the lens support, it is selected to be high enough to allow sufficient drainage of the package solution from the lens and not so high that the lens slides off the support. The minimum value of α is also determined by the clearance required between the base of the lens and the surface of the package solution. A clearance of at least about 3 - 5 mm allows the film of package solution between the lens and the solution surface to break.
[0055] Referring now to FIGS. 7A and 7B, a base 110 of a contact lens package having locking mechanisms 159a and 159b in an unlocked state and a locked state, respectively, is illustrated. In this example, two locking mechanisms 159a and 159b are used on both sides of the base 100, and the portion of the lever 118 of the base 110 is configured to pivot along a pivot line 114. As shown in the enlarged view of FIG. 7B, in this example, the locking mechanism takes the form of a snap-fit latch 159b having upper teeth 192 and lower teeth 194. The teeth 192 and 194 are shaped such that when the lever 118 is depressed, the lower teeth 194 slide on the sides of the upper teeth 192 and are then pinned under the upper teeth 192 when the lever 118 and the lens support 140 attached thereto reach a predetermined lift angle. By fixing the lower teeth 194 under the upper teeth 192, the lens support 140 can hold its position in place without the user having to continue applying force when it reaches the predetermined lift angle. It will be understood that other embodiments may use only one locking mechanism, or alternatively, three or more locking mechanisms, to achieve the same locking function, and that any number of alternative types of locking mechanisms, including but not limited to ratchets, adhesives, and / or a pair of male and female friction fit features, may be substituted. Incorporating a locking mechanism can benefit the handling experience in many ways, including at least 1) ensuring that the lens support presents the lens to the user at an angle calculated to provide sufficient drainage so that the lens does not slide off the support, 2) allowing the user to release their thumb or finger from the lever after lifting the lens, such that the same hand used to lift the lens can be used, for example, to preferably not only dab, but also pinch, or move the lens from the lens support by means of a lens insertion tool or other means, or, if desired, allow the user to place the package on a surface.
[0056] In another aspect, the base 110 includes a secondary support 196. The secondary support 196 in this example represents the upper side of a central dimple 184 formed on the lower side of the base 110, as discussed above with respect to FIG. 5. The secondary support 196 has a convex, partial dome-shaped outer profile that partially reflects the outer profile of the contact lens. The recessed areas 198a and 198b are provided on the secondary support 196 in a shape and position that allows the lens support (i.e., the primary lens support) to nest with the secondary support to form a dome shape that reflects the concave side surface of the lens 138 when the package 100 is in its unopened state. This can be referred to as a split support configuration, whereby the lens support 140 lifts the lens 138 upon opening, and the secondary support provides support to the lens only when the package is unopened (i.e., during storage, shipping, and handling), but does not provide support to the lens when the package is opened, and the lens is presented for movement when the lens 138 is supported only by the (primary) lens support 140. This configuration reduces the extra wet area that may exist between the lens and the lens support when the entire support system is lifted with the lens. The split lens support configuration can provide a number of advantages, including that the secondary support 196 fills more volume within the cavity 136, thereby reducing the amount of solution required to hydrate the lens, reducing lens damage, restricting the movement of air bubbles, and preventing lens inversion. In achieving some or all of these advantages, it is preferred, but optional, for the lens support to fill the space under the contact lens and under the periphery of the lens as much as possible, whether it is single or split between the secondary and the primary and optionally other components.
[0057] As described with respect to the embodiments herein, the lens support of the present invention can take on countless shapes and forms that are capable of lifting the lens out of the package solution when a user applies force(s) to the package, such as squeezing the package. However, as mentioned, it is preferred that the lens support hold the lens in a desired convex orientation (bowl down relative to the base) and position (centered on the support) during transport and storage. Ideally, the lens support provides an open structure under the lens to allow the package solution to drain from the lens and support without trapping water between the support and the underside of the lens upon opening. It is also preferred that the lens support provide sufficient support to the lens to prevent the lens from folding onto the support, rotating off the support, or translating across the support. This can support the apex of the lens by the elastic stiffness of the lens itself or minimize the sag of the lens apex while limiting the contact area between the support and the lens. Excessive contact between the support and the lens after solution drainage and excessive water trapped between the support and the lens can create a surface tension between the lens and the water on and around the lens support that is greater than the surface tension between the wearer's finger and the lens, potentially impeding efficient lens movement. The total contact between the lens and the lens support when the package is opened and the solution is drained from the lens and lens support is the total wet contact area, which can be less than about 30 mm 2 less than, 25 mm 2 less than, or 20 mm 2 and can be less than, and is distributed at least around the lens perimeter as described herein. As used herein, "wet contact area" refers to the direct solid contact area between the lens support and the lens, plus the area of any meniscus reservoir or solution bridge formed between the lenses after the lens has been lifted and the package solution has been drained for 2 seconds, and is measured according to the measurement protocol described below with respect to FIG. 9.
[0058] For lenses made from polymers having longer shape memory, the lens support can be designed to limit contact between the lens and the support during storage. Such contact can be distributed around the lens periphery. Contact between the lens optical zone, the lens support, and the interior of the lid (including any air inlet guides) can be transient or there may be no contact between the optical zone and the support, lid, or air inlet guide. Lenses such as conventional hydrogels having shorter shape memory tend to be less distorted from package contact and can have contact points distributed around the perimeter and over the entire lens profile, including the lens central zone (about 9 mm, or about 5 mm in diameter).
[0059] The lens support of the present invention preferably enables both the fingertip and the lens to deform to conform to each other's shape during dubbing without causing lens inversion or damage to the lens during removal from an overly large pressure during dubbing. Thus, the manner of removal of the lens from the package can be to control the ratio of the contact area between the finger and the lens compared to the area between the lens and the lens support such that the contact area between the finger and the lens exceeds the contact surface area of the lens support under the lens. This ensures that the surface tension between the finger and the lens exceeds the surface tension between the lens and the lens support. Thus, the lens adheres to the finger for lens movement and placement onto the eye.
[0060] The lens support preferably provides at least two, at least three, 3 to 14, 4 to 14, 3 to 8, or 4 to 8, 4 to 6, or 6 contact points with the contact lens edge along the peripheral support, and the lens support has no ends or cuts, and the contact with the lens occurs at various locations along a continuous support structure, taking the form of a continuous design, also referred to as a "closed circuit". When two peripheral supports are used, they can be wider to provide stability without exceeding the contact area desired for consistent one-touch lens movement. The peripheral contact points can be distributed in a number of configurations that prevent the lens from coming off the lens and rotating, and the space between the farthest adjacent contacts is smaller than the diameter of the lens. As the number of peripheral supports increases, the possibility of the residual package solution forming a film between adjacent peripheral supports and a solution bridge between the support and the lens can increase during discharge. Peripheral supports with less than 50% open space, such as those in the form of a screen or strainer, generally provide insufficient drainage to ensure one-touch lens movement. Similarly, excessive contact between the support and the lens after solution discharge and excessive water trapped between the support and the lens can generate a surface tension between the lens and the water on and around the lens support that is greater than the surface tension between the wearer's finger and the lens, potentially interfering with efficient lens movement. The width of the constituent support member of the lens support varies between the limits of the selected molding process and the width required for efficient package solution drainage upon opening. Suitable widths include from about 0.5 to about 1.5 mm, from about 0.5 to about 1, or from about 0.5 to about 0.7 mm, and it will be understood that lens support designs with fewer contact points can have thicker arms.
[0061] The lens support can achieve sufficient drainage of the package solution from the lens to enable one-touch movement by one or a combination of the drainage techniques referred to herein as channel drainage and back drainage. Channel drainage involves the formation of a film on the lens support of the channel member where, when the lens support is lifted, the package solution flows out of the lens through the channel under gravity. On the other hand, back drainage refers to enhanced drainage directly from under the lens into the package solution reservoir where the lens is placed on the lens support. This area under the apex of the lens has a tendency to trap the package solution due to the hydrophilic nature of modern contact lens materials. In some embodiments, enhanced back drainage can be achieved by designing a lens support having a central opening of at least about 12 mm 3 beneath the apex of the lens.
[0062] Next, referring to FIGS. 8A and 8B, an exemplary lens support 140 in a side view and a top view respectively is illustrated. The lens support 140 represents an example of a lens support that utilizes a hybrid of back drainage and channel drainage to sufficiently remove the package solution from the lens to enable one-touch movement. The lens support 140 includes a closed-loop design that includes a central support portion composed of central support sections 200a and 200b having a partially circular configuration with an inner diameter of about 6 mm. The central support sections 200a and 200b are 1 mm higher with respect to the lens base.
[0063] The design of the lens support 140 creates a central opening 212 having a 6 mm diameter that allows the package solution to be drained from the lens and the lens support 140 out the back when the package is opened, a lens support lifted from the package solution, and an unsupported area sufficient to allow the lens apex to deform slightly under dubbing pressure, and thus achieve sufficient contact area with a finger (or other lens moving means) to achieve one-touch movement. By sizing the central opening 212, while limiting the contact area between the support 140 and the lens, the apex of the lens is supported by the elastic rigidity of the lens itself and the sag of the lens apex can be minimized. This design also provides sufficient support at the edges of the contact lens at points A, B, C, and D along the peripheral support sections 201a - 201d. This configuration allows for a 2-second drain after the lens support 140 is lifted and then sufficiently reduces the wet contact area between the lens support 140 and the contact lens to about 22 mm 2 until the measurement is made in accordance with the measurement protocol described herein with respect to FIG. 9. The design of the lens support 140 further prevents the lens from being partially laterally crushed by the peripheral support sections 201a - d that more stably cause the package solution of the film 206 initially formed on the supports 205a and 205b to drain and by holding the sides of the lens under tension until the lens is substantially drained.
[0064] The distal end 208 of the lens support 140 is open not only to facilitate the lens support clearing the lid insert 170 when the lens support is lifted, but also to reduce the incidence of the lens popping out of the lens support during lifting. The lens support also includes a discharge channel 202 to assist in lens discharge. The discharge channel 202 is formed by channel members 204a and 204b extending from the tab portion 163 of the lens support 140 and has a width of about 2 mm and a length of 2.3 mm. When the lens is lifted, a film of the package solution is formed along the lens support members (central and peripheral). The discharge channel, if present, cooperates with the lens support to create a temporary film of the package solution flowing out of the lens and a path for gravity to act to discharge that film. In this way, the discharge channel serves to minimize the retention of the package solution between the rear of the lens and the lens support structure when the package is opened and the lens support is lifted or tilted out of the package solution. The discharge channel comprises at least one channel member. The discharge channel includes a gap between two adjacent members or, if a single member is used, a slit within the single member. In the case of a lens support without an all-around ring, the discharge channel gap can start at any point inside the lens periphery. The discharge channel can extend beyond the lens periphery with a length of at least 2 mm, about 2 to about 4 mm, or about 2.5 to about 3.5 mm. The discharge channel gap can provide space outside the periphery of the contact lens for air flow, ensuring that air and the package solution from the concave surface of the lens can be discharged without sucking the lens onto the lens support upon opening. As can be seen in FIG. 8B, the lens support 140 is also configured with an offset from the horizontal plane of the tab 163 such that the side supports 205a and 205b of the lens support 140 slope downward at a primary angle (θ) of 10 degrees. The lens support 140 has a lever length (L) of 13 mm.
[0065] It must be emphasized that the embodiments of the lens support illustrated and described in this specification are merely two of countless embodiments of the lens support within the scope of the present invention as recited in the appended claims. To ensure this, a number of additional illustrative but non-limiting exemplary lens supports are depicted in Appendix A.
[0066] The protocol for measuring the wet contact area is described below with reference to FIG. 9, which shows digital images used to perform wet contact area measurements at various stages of digital processing. First, in one step, the cavity of the contact lens package is filled with 16 parts of a package solution to 1 part of a dye (e.g., Stone England Claret fountain pen ink) such that at least the contact lens and the lens support are immersed. Next, the lens support is lifted according to the normal operation of the package, such as by depressing a lever (not shown). The lens support and the lens are maintained in their fully lifted position or a double angle according to a particular package design. The lens support is then removed, placed on a white surface, and imaged using a digital camera (having at least 12 megapixels) directly above the lens support at a height of about 4 inches in a neutral lighting environment to generate an image such as image 902. The image used for the measurement should be captured within 30 seconds after being removed from the package to avoid evaporation losses.
[0067] In the next step, image 902 is digitally scaled according to the diameter of the central section (6 mm in diameter in this example). Next, the image is converted to black and white using a selected threshold level at which dark sections that are clearly not adhered to the lens support are removed (e.g., converted to white). Any areas of solid contact with the lens support are also converted to white to avoid double counting. This distinguishes the meniscus area from the fluid film adhered to the lens.
[0068] Next, the image is divided into sections by cutting the image into three different images 903a, 903b, and 903c (6 mm in diameter, 8 mm in diameter, and 14.2 mm in diameter), taking into account the distortion due to the vertical projection at the edge of the lens. Next, the white and black pixels of each section are counted, and the meniscus area is calculated as the ratio of white pixels to black pixels multiplied by the 3D surface area of each section on the back curve shape of the lens. Finally, the total wet area is calculated as the sum of the solid contact area of the lens support (which can be measured in CAD) and the meniscus area.
[0069] The foregoing description has used a particular terminology system for purposes of explanation to provide a complete understanding of the described embodiments. However, it will be apparent to those skilled in the art that many details are not required to practice the described embodiments. Accordingly, the foregoing description of the specific embodiments described herein is presented for purposes of illustration and explanation. They are not intended to be exhaustive or to limit the disclosure to the exact form disclosed. It will be apparent to those skilled in the art that many modifications and variations are possible in light of the above teachings.
[0070] The "Summary of the Invention" and "Abstract" sections may present one or more but not all exemplary embodiments of the invention as contemplated by the inventors, and are therefore not intended to limit the invention and the appended "Claims" in any way.
[0071] From the foregoing description of the specific embodiments, the general nature of the present invention will be fully apparent, and others can, by applying the knowledge of those skilled in the art, without undue trial and error and without departing from the general concept of the present invention, easily modify and / or adapt such specific embodiments to various uses. Therefore, such adaptations and modifications are intended to be within the meaning and scope of the equivalents of the disclosed embodiments based on the teachings and guidance presented herein. It should be understood that the phraseology or terminology of this specification is for the purpose of description and not of limitation, and thus the phraseology or terminology of this specification should be interpreted by those skilled in the art from the perspective of the teachings and guidance.
[0072] The package of the present invention can be manufactured using known materials and processes. The package materials can be virgin, recycled, or a combination thereof. The volume within the package cavity can vary according to the selected design.
[0073] It is not necessary to incorporate all the features described herein into all packages, and those skilled in the art can use the teachings herein to combine these features to provide a wide variety of improved contact lens packages. In summary, the contact lens packages of the present invention incorporate several novel functions that can be combined in a wide variety of combinations as described herein to provide the desired improved and / or one-touch packages. The breadth and scope of the present invention should not be limited by any of the above exemplary embodiments, but should be defined only in accordance with the following "claims" and their equivalents.
[0074] Appendix A
[0075] TIFF2025519874000003.tif165128
[0076] TIFF2025519874000004.tif194128
[0077] TIFF2025519874000005.tif182128
[0078] TIFF2025519874000006.tif149151
[0079] TIFF2025519874000007.tif182128
[0080] TIFF2025519874000008.tif67128
[0081] [Embodiment] (1) A contact lens package, comprising: a lid, a base, a cavity for containing a contact lens and a package solution, a lever, and a base, a lens support, which is coupled to the lever and is configured to lift the contact lens from the package solution to a position on the lens support where it can be moved by one touch by the user. A contact lens package comprising the lens support. (2) The contact lens package according to Embodiment 1, wherein at least one of the lever and the lens support is a separate component coupled to the base by attachment means. (3) The contact lens package according to Embodiment 1, wherein a pivot line is defined by at least one void in the base. (4) The contact lens package according to Embodiment 1, wherein the pivot line is imparted to the base by one or more of a fold, a cut, a thin line, and an etching. (5) The contact lens package according to Embodiment 1, wherein the base is made of a relatively rigid material.
[0082] (6) The contact lens package according to embodiment 5, wherein the lid includes a film and the base includes a plastic material. (7) The contact lens package according to embodiment 1, wherein the base and the lens support are a single integral component. (8) The contact lens package according to embodiment 1, wherein the lever and the lens support are a single integral component. (9) The contact lens package according to embodiment 1, wherein the lens support is coupled to the base by at least one of i) laser welding, ii) heat, iii) ultrasonic welding, and iv) an adhesive. (10) The contact lens package according to embodiment 1, wherein the base comprises at least one finger engagement feature configured to i) assist a user in gripping the package or i) direct the application of force such that the lever pivots downward.
[0083] (11) The contact lens package according to embodiment 10, wherein the at least one finger engagement feature comprises a dimple sized to correspond to a finger or thumb of the user, the dimple being positioned at an end of the base proximal to the user. (12) The contact lens package according to embodiment 1, further comprising a locking mechanism configured to lock the lever in place when the lens support is lifted to a predetermined lift angle. (13) The contact lens package according to embodiment 12, wherein the locking mechanism comprises at least one of a latch, a ratchet, a peg, and an adhesive. (14) The contact lens package according to embodiment 12, wherein the predetermined lift angle is at least about 45 degrees. (15) The contact lens package according to Embodiment 1, wherein the lens support is configured such that when lifted, the upper side of the contact lens emerges from the package solution in front of the lower side of the contact lens.
[0084] (16) The contact lens package according to Embodiment 15, wherein the lens support has an emergence angle of at least 0 degrees or at least 5 degrees. (17) The contact lens package according to Embodiment 15, wherein the lens support has a primary lens angle of -4 degrees to 20 degrees and a lever length of about 11 mm to 16 mm. (18) The contact lens package according to Embodiment 1, wherein the lid includes at least one surface facing the lens that extends downward into the cavity above the contact lens when the package is in an unopened state. (19) The contact lens package according to Embodiment 18, wherein the surface facing the at least one lens and the lens support are configured within the cavity such that when the package is in an unopened state, the optical zone of the contact lens is present in the package solution between the surface facing the lens and the lens support. (20) The contact lens package according to Embodiment 1, further comprising a secondary support configured to support the lens only when the package is unopened.
[0085] (21) The contact lens package according to Embodiment 20, wherein the secondary support has at least one recessed area in a shape and position that allows the lens support to be nested with the secondary support to form a dome shape that reflects the concave side surface of the lens when the package is in an unopened state. (22) The contact lens package according to any one of Embodiments 1 to 21, wherein the cavity accommodates the contact lens in a convex position when the package is in an unopened or opened state. (23) When the package is in an open state, the wet contact area between the lens support and the contact lens is about 30 mm 2 less than, about 25 mm 2 less than, or about 20 mm 2 less than, the contact lens package according to any one of Embodiments 1 to 21. (24) having at least one surface facing the lens on the convex side surface of the contact lens within the cavity, and when the package is in a sealed state, the surface facing the at least one lens is configured to align the contact lens on the lens support or to protect the contact lens from significant optical damage due to gravity, mechanical force, or air-induced force, the contact lens package according to Embodiment 1. (25) The surface facing the at least one lens is provided on a lid insert, and the lid insert is attached to the inner surface of the lid, the contact lens package according to Embodiment 24.
[0086] (26) The lid insert includes at least one alignment feature, the contact lens package according to Embodiment 25. (27) The lid insert includes at least one lockout feature, the contact lens package according to Embodiment 25. (28) A contact lens package including a contact lens in a package solution, a lens support, and a locking mechanism, wherein the lens support is configured to lift the contact lens out of the package solution, and the locking mechanism is configured to lock the lens support having the contact lens thereon at a predetermined lifting angle. (29) The package includes a lever, and the lever is configured to cause the lens support to lift the contact lens out of the package solution when a user applies a force to the lever, the contact lens package according to Embodiment 28. (30) The package is configured such that the force applied to the lever causes the lens support to lift the contact lens from the package solution to a position on the lens support where one-touch movement by the user is possible, as described in Embodiment 29.
[0087] (31) The contact lens package according to Embodiment 29, wherein at least one of the lever and the lens support is a separate component coupled to the base by attachment means. (32) The contact lens package according to Embodiment 29, wherein the base is made of a relatively rigid material. (33) The contact lens package according to Embodiment 28, wherein the base and at least one of the lever and the lens support are a single integrated component. (34) The contact lens package according to Embodiment 29, wherein the lever and the lens support are a single integrated component. (35) The contact lens package according to Embodiment 29, wherein the lens support is coupled to the base by at least one of i) laser welding, ii) heat, iii) ultrasonic welding, iv) mechanical clipping, and v) an adhesive.
[0088] (36) The contact lens package according to Embodiment 29, wherein the base comprises at least one finger engagement feature configured to assist the user in gripping the package or to direct the application of the force such that the lever pivots downward. (37) The contact lens package according to Embodiment 28, further comprising at least one finger engagement feature having a dimple sized to correspond to the finger or thumb of the user, the dimple being positioned at an end of the base proximal to the user. (38) The contact lens package according to embodiment 28, wherein the locking mechanism includes at least one of a latch, a ratchet, a peg, and an adhesive. (39) The contact lens package according to embodiment 28, wherein the predetermined lifting angle is at least about 45 degrees. (40) The contact lens package according to embodiment 28, wherein the lens support is configured such that when lifted, the upper side of the contact lens emerges from the package solution in front of the lower side of the contact lens.
[0089] (41) The contact lens package according to embodiment 28, wherein the lens support has an emergence angle of at least 0 degrees or at least 5 degrees. (42) The contact lens package according to embodiment 28, wherein the lens support has a primary lens angle of -4 degrees to 20 degrees and a lever length of about 11 mm to 16 mm. (43) The contact lens package according to embodiment 29, wherein the lid of the package has a surface facing the lens that extends downward into the cavity above the contact lens when the package is in an unopened state. (44) The contact lens package according to embodiment 43, wherein the surface facing the lens and the lens support are configured such that when the package is in an unopened state, the optical zone of the contact lens is present in the package solution between the surface facing the lens and the lens support. (45) The contact lens package according to embodiment 28, further comprising a secondary support configured to support the lens only when the package is unopened.
[0090] (46) The secondary support is in a shape and position that enables the lens support to be nested with the secondary support to form a dome shape that reflects the concave side surface of the lens when the package is in an unopened state, and includes at least one recessed area, the contact lens package according to embodiment 45. (47) The package is the contact lens package according to any one of embodiments 28 to 45, which houses the contact lens in a convex position when the package is in an unopened state or an opened state. (48) When the package is in an opened state, the wet contact area between the lens support and the contact lens is less than about 30 mm 2 less than, less than about 25 mm 2 less than, or less than about 20 mm 2 The contact lens package according to any one of embodiments 28 to 45. (49) The package includes at least one surface facing the lens on the convex side surface of the contact lens within the cavity, and when the package is in an unopened state, the surface facing the at least one lens is configured to align the contact lens on the lens support or to protect the contact lens from significant optical damage caused by gravity, mechanical force, or air-induced force. The contact lens package according to embodiment 28. (50) The contact lens package according to embodiment 28, further comprising a lid insert.
[0091] (51) The contact lens package according to embodiment 50, wherein the lid insert includes at least one alignment feature. (52) The contact lens package according to embodiment 50, wherein the lid insert includes at least one lockout feature. (53) A lens support for lifting a contact lens from a packaging solution within a contact lens package, wherein the lens support holds the lens in a convex position and is configured such that when lifted, the upper side of the contact lens emerges from the packaging solution in front of the lower side of the contact lens. (54) The lens support according to embodiment 53, wherein the lens support has an emergence angle of at least 0 degrees or at least 5 degrees. (55) The contact lens package according to embodiment 53, wherein the lens support has a primary lens angle of -4 degrees to 20 degrees and a lever length of about 11 mm to 16 mm.
[0092] (56) The lens support is less than about 30 mm 2 less than, about 25 mm 2 less than, or about 20 mm 2 The contact lens package according to embodiment 53, which is configured to produce a wet contact area less than. (57) A contact lens package, a lid, a base made of a relatively rigid material, a cavity for containing a contact lens and a packaging solution, a lever, and a base comprising, a lens support coupled to the lever and configured to lift the contact lens from the packaging solution to a position on the lens support where it can be moved by a user with one touch. A lens support for lifting a contact lens from a package solution housed in a cavity within a base of a contact lens package, the lens support holding the lens in a convex position, and the lens support being configured such that when lifted, an upper side of the contact lens emerges from the package solution in front of a lower side of the contact lens.
Claims
1. It is a contact lens package, The lid and A base made of a relatively rigid material, The aforementioned contact lens package has a cavity that houses the contact lens and package solution, which is in a convex position when the package is unopened or opened. A base equipped with a lever, A contact lens package comprising: a lens support connected to the lever, configured to lift the contact lens from the package solution to a position on the lens support that can be moved with a single touch by the user.
2. The contact lens package according to claim 1, wherein at least one of the lever and the lens support is a separate component that is coupled to the base by mounting means.
3. The contact lens package according to claim 1, wherein the pivot line is defined by at least one void in the base.
4. The contact lens package according to claim 1, wherein pivot lines are provided on the base by one or more of the following: folds, cuts, fine lines, and etchings.
5. The contact lens package according to claim 1, wherein the lid includes a film and the base includes a plastic material.
6. The contact lens package according to claim 1, wherein the base and the lens support are a single, integrated component.
7. The contact lens package according to claim 1, wherein the lever and the lens support are a single, integrated component.
8. The contact lens package according to claim 1, wherein the lens support is bonded to the base by at least one of i) laser welding, ii) heat, iii) ultrasonic welding, and iv) adhesive.
9. The contact lens package according to claim 1, wherein the base comprises at least one finger engagement feature configured to i) assist the user in grasping the contact lens package, or i) direct the application of force so that the lever hinges downward.
10. The contact lens package according to claim 9, wherein the at least one finger engagement feature includes a dimple sized to correspond to the user's finger or thumb, and the dimple is located at the proximal end of the base relative to the user.
11. The contact lens package according to claim 1, further comprising a locking mechanism configured to lock the lever in place when the lens support is lifted to a predetermined lifting angle.
12. The contact lens package according to claim 11, wherein the locking mechanism includes at least one of a latch, a ratchet, a peg, and an adhesive.
13. The contact lens package according to claim 11, wherein the predetermined lifting angle is at least about 45 degrees.
14. The contact lens package according to claim 1, wherein the lens support is configured such that when lifted, the upper side of the contact lens emerges from the package solution before the lower side of the contact lens.
15. The contact lens package according to claim 14, wherein the lens support has an appearance angle of at least 0 degrees or at least 5 degrees.
16. The contact lens package according to claim 14, wherein the lens support has a primary lens angle of -4 to 20 degrees and a lever length of approximately 11 mm to 16 mm.
17. The contact lens package according to claim 1, wherein the lid has a surface facing at least one lens that extends downward into the cavity over the contact lens when the contact lens package is in the unopened state.
18. The contact lens package according to claim 17, wherein the surface facing the at least one lens and the lens support are configured within the cavity such that, when the contact lens package is in the unopened state, the optical zone of the contact lens is present in the package solution between the surface facing the at least one lens and the lens support.
19. The contact lens package according to claim 1, further comprising a secondary support configured to support the contact lens only when the contact lens package is unopened.
20. The contact lens package according to claim 19, wherein the secondary support includes at least one recessed area that is shaped and positioned to allow the lens support to nest together with the secondary support to form a dome shape that reflects the concave side surface of the contact lens when the contact lens package is in the unopened state.
21. When the contact lens package is in the opened state, the wet contact area between the lens support and the contact lens is approximately 30 mm². 2 Less than approximately 25 mm 2 Less than or approximately 20 mm 2 A contact lens package according to any one of claims 1 to 20, wherein the package is less than [amount missing].