Patent Application
20240099435
In a conventional contact lens package, the contact lens typically sits in a molded plastic base having a cavity (or “bowl”) that houses the contact lens in a concave-side-up orientation. As a result, the user experience for transferring a contact lens from the package to an eye generally involves the user “fishing” the contact lens out of the bowl with a finger and then flipping the lens so that it is in the correct orientation on the finger for placement on the eye. This process requires touching the lens multiple times, which can transfer contaminants or pathogens from the hand to the lens and ultimately to the eye. Not only is this handling experience unsanitary, but it is also unduly cumbersome, messy, and mechanically stressful to the lens, which can tear, rip, or distort when overly manipulated. While some packages have been designed to present the lens in a convex-side-up orientation to obviate the need for flipping the lens, they often still require the lens to be “fished” from the packaging solution or otherwise necessitate manipulation of the lens and/or multiple touches of the lens to achieve transfer of the lens to the eye. In view of the growing awareness around ocular health and the customer demand for a more convenient experience, a need has arisen for contact lens packaging that enables a less messy and more sanitary contact lens handling process.
Among other considerations: it would be desirable for wearers to be able to drain away any packaging solution which might impact the ability of adhering the lens to the finger or holder, as variation in the amount of packaging solution adhering to the lens and package can impact the process of placing the lens on the finger. Also, the wearer may be concerned about the potential of transferring bacteria or external products such as make up to the contact lens; and of course, manufacture of the package itself should conform to expected industry standards recognized by the medical and commercial provider communities.
There remains a need for contact lens packages which provide a single-touch lens removal experience, effective solution management, or addresses one or a combination of the aforementioned challenges or deficiencies.
It has now been found that some or all the foregoing and related objects may be attained in a contact lens package having one or more aspects described herein. For example, in some implementations, a flat contact lens package has a base component including a hinge and a lid component sealedly coupled to the base component, wherein the base component and the lid component define a cavity configured to accommodate a contact lens and a packaging solution. The package is configured such that upon opening the package by a wearer the packaging solution drains away from the contact lens.
According to one implementation, a flat contact lens package includes a base component including a hinge and a lid component sealedly coupled to the base component. The base component and the lid component define a cavity configured to accommodate a contact lens and a packaging solution. Additionally, in an unopened state, the base component is biased toward the lid component, while in an opened state, a portion of the base component is configured to pivot about the hinge and drain the packaging solution.
Additionally, the flat contact lens package optionally has a planar shape in the unopened state.
Alternatively or additionally, the base component includes one or more sheets of material. Optionally, the one or more sheets of material include a foil.
Alternatively or additionally, the lid component includes one or more sheets of material. Optionally, the one or more sheets of material include a foil.
Alternatively or additionally, the portion of the base component is configured to pivot about the hinge in a direction away from the lid component in the opened state. For example, the portion of the base component is configured to pivot between 25 and 180 degrees about the hinge.
In some aspects, the hinge is optionally a living hinge.
In some aspects, the hinge divides the base component into a first region and a second region. Additionally, the hinge includes a thinned portion of the base component, where the thinned portion is arranged between the first region and the second region.
In some aspects, the hinge extends along a transverse axis of the base component. For example, the base component has a first edge, a second edge, a third edge, and a fourth edge, where the first and second edges extend substantially in parallel to one another, and where the third and fourth edges extend substantially in parallel to one another. Optionally, a length of the first and second edges is greater than a length of the third and fourth edges. Alternatively or additionally, the transverse axis optionally extends substantially in parallel to the third and fourth edges.
In some aspects, the package optionally further includes a support component arranged in the cavity. The support component is configured to support the contact lens in a convex-side-up orientation.
According to one implementation, a method of applying a contact lens to a wearer's eye is described. The contact lens is stored in a flat contact lens package including a base component including a hinge and a lid component sealedly coupled to the base component. The base component and the lid component define a cavity configured to accommodate the contact lens and a packaging solution. Additionally, in an unopened state, the base component is biased toward the lid component. The method includes separating the lid component and the base component; allowing a portion of the base component to pivot about the hinge; draining the packaging solution from the cavity; manipulating the contact lens with the wearer's finger; and applying the contact lens to the wearer's eye.
Optionally, the method further includes manually pivoting the portion of the base component about the hinge.
Optionally, the step of manipulating the contact lens with the wearer's finger is performed with a single touch.
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.
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. 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.
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.
As used herein, the following terms have the following meaning. A benefit of the certain embodiments the present invention is that they facilitate 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.
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.
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.
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.
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, 9,156,934, 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.
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.
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.
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.
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 a lens support.
Embodiments may include a package providing a sealable cavity also interchangeably referred to as a reservoir. The cavity may have any convenient form and may comprise a package bottom floor, a package ceiling, and walls, each of which are described in detail below. As used herein, the phrases “the lid component”, “a lid”, “the base component”, “a base component”, “the container” and “a container” encompass both the singular and plural. The lid component and base component are sealed to each other to form a cavity which holds the contact lens 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.
“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 a component of 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.
An “unopened state” or “unopened” as used herein refers to a contact lens package that is closed and houses a contact lens in solution.
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.
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.
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.
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.
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.
As described above, design of a single touch lens package faces distinct challenges. Such challenges include, but are not limited to, the user being able to consistently position the contact lens to adhere to the user's finger, and then consistently releasing the contact lens from the user's finger onto the eye. Consistency in taking the contact lens from an opened contact lens package onto the user's finger benefits from a mechanism for efficient draining of packaging solution from the contact lens within the package prior to manipulating the contact lens with the user's finger.
Flat contact lens packages addressing one or more of the challenges above are described below. In one implementation described herein, a flat contact lens package includes a base and a lid that is sealed against the base, where the base and the lid cooperate to define an interior space (i.e., a cavity) for accommodating a contact lens and a packaging solution. The base is pivotable about a living hinge formed in the material of the base along a transverse direction of the base. When the package is in a sealed state (i.e., unopened state), the base is biased to by the lid such that the package has a planar shape. On the other hand, when the package is in an unsealed state (i.e., opened state), the base pivots about the living hinge to allow the packaging solution to drain from the lens.
Referring now to
As shown in
Still referring to
Additionally, as shown in
In one aspect, as shown in
The hinge 106 (e.g., the thinned portion 114 of the base component 102) may be formed using known processing techniques. For example, in some implementations, the hinge 106 may be formed using cold forming processes, where materials of the base component are shaped at or near ambient room temperature. In other implementations, the hinge 106 may be formed using hot forming processes such as hot stamping or press hardening, where materials of the base component are shaped at elevated temperatures. In yet other implementations, the hinge 106 may be formed using molding processes. In yet other implementations, the hinge 106 may be formed using subtractive or additive manufacturing processes. Cold forming, hot forming, molding, and subtractive or additive manufacturing processes are known in the art and therefore not described in further detail herein. This disclosure contemplates using any process or processes that impart a hinge-like structure to the base component 102.
Optionally, the hinge 106 is a living hinge. As used herein, a living hinge is a thinned piece of material surrounded by thicker material. A living hinge allows for a portion of the base component 102 to bend or fold from 1 to 180 degrees about the hinge 106. As described above, the bending or folding creates tensile stress in the material of the living hinge. Accordingly, the thickness of the thinned piece of material of the living hinge is selected to provide desired strength such that the package 100 does not tear.
In the unopened state, as shown in
Referring now to
Still referring to
Referring now to
As shown in
Referring now to
Additionally, the package further includes a support component 124 arranged in the cavity. The support component 124 may be an elongate rod, which is configured to interface with the concave surface of the contact lens 150. Optionally, the support component 124 may include a plurality of components, each being configured to interface with the concave surface of the contact lens 150. In some aspects, the support component 124 is fixed to a surface of the hinge 106. In other aspects, the support component 124 is not fixed to a surface of the hinge 106. It should be understood that the size, shape, and arrangement of the support component 124 is provided only as an example. This disclosure contemplates a support component having a different size, shape, and/or arrangement.
As shown in
Referring now to
In any of the above-described embodiments, it is anticipated the wearer is the user, but the above-described embodiments also describe the situation in which the wearer is not the same person as the user, for example, in a medical or caretaker setting in which a caregiver applies a contact lens to the eye of a patient.
Further aspects of the invention may be further understood with reference to the following, non-limiting examples:
Example 1. A flat contact lens package comprising:
Example 2. The flat contact lens package of example 1, wherein the flat contact lens package has a planar shape in the unopened state.
Example 3. The flat contact lens package of example 1 or 2, wherein the base component comprises one or more sheets of material.
Example 4. The flat contact lens package of example 3, wherein the one or more sheets of material include a foil.
Example 5. The flat contact lens package of example 1 or 2, wherein the lid component comprises one or more sheets of material.
Example 6. The flat contact lens package of example 5, wherein the one or more sheets of material include a foil.
Example 7. The flat contact lens package of any one of examples 1-6, wherein the portion of the base component is configured to pivot about the hinge in a direction away from the lid component in the opened state.
Example 8. The flat contact lens package of example 7, wherein the portion of the base component is configured to pivot between 1 and 180 degrees about the hinge.
Example 9. The flat contact lens package of any one of examples 1-8, wherein the hinge is a living hinge.
Example 10. The flat contact lens package of any one of examples 1-8, wherein the hinge divides the base component into a first region and a second region.
Example 11. The flat contact lens package of example 10, wherein the hinge comprises a thinned portion of the base component, wherein the thinned portion is arranged between the first region and the second region.
Example 12. The flat contact lens package of any one of examples 1-11, wherein the hinge extends along a transverse axis of the base component.
Example 13. The flat contact lens package of example 12, wherein the base component has a first edge, a second edge, a third edge, and a fourth edge, wherein the first and second edges extend substantially in parallel to one another, and wherein the third and fourth edges extend substantially in parallel to one another.
Example 14. The flat contact lens package of example 13, wherein a length of the first and second edges is greater than a length of the third and fourth edges.
Example 15. The flat contact lens package of example 13 or 14, wherein the transverse axis extends substantially in parallel to the third and fourth edges.
Example 16. The flat contact lens package of any one of examples 1-15, further comprising a support component arranged in the cavity.
Example 17. The flat contact lens package of example 16, wherein the support component is configured to support the contact lens in a convex-side-up orientation.
Example 18. A method of applying a contact lens to a wearer's eye, the contact lens being stored in a flat contact lens package comprising a base component comprising a hinge and a lid component sealedly coupled to the base component, wherein the base component and the lid component define a cavity configured to accommodate the contact lens and a packaging solution, and wherein the base component is biased toward the lid component in an unopened state, the method comprising:
Example 19. The method of example 18, further comprising manually pivoting the portion of the base component about the hinge.
Example 20. The method of example 18 or 19, wherein manipulating the contact lens with the wearer's finger is performed with a single touch.
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.
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.
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.
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.
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 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.
