Patent Application
20230083028
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. In one respect, it would be ideal to provide wearers of contact lenses with a “single touch” package—that is, a package whereby the wearer of contact lenses can take the lens from the lens storage package with a single touch of one of his or her fingers, and then, with this single touch, position the lens correctly on the eye. In such a design, there would be no need for transfer and manipulation of the lens from one finger to another before placing the lens on the eye. Providing such a single touch package would not only streamline the lens preparation and insertion process; it would also diminish the possibility of dropping the lens or exposing the lens to additional bacteria on a wearer's other fingers as the lens is being prepared for orientation and insertion onto the eye, and it also reduces the possibility of touching the side of the lens which is intended to contact the eye.
Design of a single touch lens package faces some distinct challenges. The wearer ideally should be able to consistently position the lens to adhere to the finger during removal from the package, and then the lens needs to consistently release from the finger onto the eye. Contact lenses (of both the reusable and daily disposable variety) each has its own unique surface, bulk, and geometric properties. Finger size and the force a contact lens wearer imparts on the lens during transfer can also vary. These factors can impact the process for taking the lens from the package onto the finger and then onto the surface of the eye. 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, 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. It would also be desirable for package solution to drain away in a controlled fashion that avoids spillage. It would also be beneficial for the packaging solution to remain sterile and accessible to the wearer after opening to permit re-wetting or cleansing of the lens. 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.
Further, the single touch package ideally should not result in an inordinate increase in the cost of goods over current contact lens packages, as this could result in increased costs to the wearer community. The package should not make it difficult to hold the lens when removed from the package. Additionally, if the configuration of the package were to maintain, or even reduce the volume of solution needed to package the lens, this would reduce the ecological impact of the lens package. Similarly, it would be beneficial if all or part of the package could be made of recycled materials, and/or recyclable in whole or part.
In addition, it would be advantageous if the package were composed of materials that are already approved by the various regulatory bodies and ideally did not require a change in solution chemistry or lens composition. Optimally, as well, the functionality of the package preferably does not incorporate any electronics or other electrical components if such components could adversely affect performance of either the package or the lens.
There are several desirable attributes that have made achieving the function of a single touch package challenging and that are often lacking in known attempts to create a single touch package. These attributes include, for example, the following: i) the package ideally should protect the lens, i.e., it should ensure the lens's integrity (e.g., lens shape and optical integrity), while at the same time prevent crushing or damage to the lens; ii) the lens package should maintain the hydration of the lens when stored to maintain the lens's properties; and iii) the lens in its package preferably should be configured so that when desired, it is fully submerged in the packaging solution, yet be cleared of such solution when ready to be transferred from the packaging; iv) the package generally should have a retortable seal and contain both the lens and solution; v) the package preferably should maintain the lens in the desired convex orientation to the wearer; vi) the lens should be positioned so that it can be easily removed by the wearer; and vii) the package ideally should allow the packaging solution to be effectively drained away from the lens upon opening of the packaging and prior to lens removal to enable easier transferred to the wearer's finger and then onto the eye.
Known packages that have sought to provide reduce-touch or single touch orientations fail to provide one or more of the above-noted desired attributes for a single-touch package. For example, WO2014/195588, WO2009/069265, JP6339322 disclose packages which present the lens in a convex, bowl down configuration. However, the lens support structures substantially match the shape of the contact lens, which provides undesirable contact area between the lens and lens support. These references are also silent as to mechanisms for effective solution drainage from the lens and lens support.
Similarly, US20200229560 discloses packages with lens supports that support the concave (anterior or front) surface of the contact lens, or grates that support the contact lens peripheral edge and allows packaging solution to drain through a grate to a bottom chamber upon opening the lens package. The foregoing noted deficiencies of the prior art are merely exemplary and not exhaustive.
Thus, there remains a need for contact lens packages which provide a consistent 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, a contact lens package of the invention may house a contact lens and packaging solution wherein the package is configured to lift the contact lens out of the packaging solution when the package is squeezed by a user. The contact lens package may have a lid and a base that includes a cavity that houses a contact lens and packaging solution and a lever configured to hinge along a pivot line in the base when a force is applied to the lever. The package may further include a lens support that intersects the pivot line such that force applied to the lever causes the lens support to lift the contact lens out of the packaging solution in a position on the lens support capable of single-touch transfer by a user. In some cases, the lever is a discrete component that is coupled to the base by an attachment means. The pivot line may be defined by at least one void in the base and may be imparted into the base by one or more of: a crease, a cut, a thinned line, and an etch or the like. The base of the package may be composed of plastic and the lid may be a film. In some cases, the base and the lens support and/or the lever and lens support are a single unitary component.
A lens support may be coupled to the base by i) a laser weld; ii) heat; iii) an ultrasonic weld; iv) an adhesive, or the like. The base may include one or more finger engagement features configured to aid a user in grasping the package or direct the application of force such that the lever hinges downward. Possible figure engagement features includes a protrusion in the base at a distal end of the package and/or an overhang along at least a portion of the package's periphery. A dimple sized to accommodate a finger or thumb of the user may be positioned at an end of the base proximal to the user. Finger engagement features may be paired such that one is positioned at an end of the base proximal to the user and another is distal finger engagement feature positioned at an end of the base distal to the user. Alternatively, finger engagement features may be positioned at any other opposed side or end of the package.
The lid of the package may include one or more lens facing surfaces that extends downward into the cavity above the contact lens when the package is in an unopened state. The lens facing surface and lens support may be configured within the cavity such that the optical zone of the contact lens is suspended in the packaging solution between the lens facing surface and lens support when the package is in an unopened state. The cavity of the package may house the contact lens in a convex position when the package is in an unopened or opened state. And the lens support may have a profile that does not substantially match the contact lens's profile. When the package is an opened state, the wetted contact area between the lens support and the contact lens may be less than about 30 mm2, less than about 25 mm2, or less than about 20 mm2. The package may include a lid insert having at least one alignment feature and/or one or more lock-out features.
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 consistent single-touch lens transfer from the package to a wearer's finger, and then from the finger to the wearer's eye without the lens inverting, falling off the finger or further manipulation. Consistent lens transfer includes a transfer rate of at least about 70%, at least about 80% or at least about 90% transfer on the first touch of the finger (or “dab”). The lens also desirably “sits up” on the finger without collapsing or inverting and then transfers to the eye when placed there. Packages of certain embodiments may provide the desired single-touch transfer across a range of finger sizes, and dab pressures. Environmental conditions such as the temperature and whether the finger is wet or dry may also impact transfer rate, with higher temperatures generally improving lens transfer.
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, 9156,934, 9,170,349, 9,244,196, 9,244,197, 9,260,544, 9,297,928, 9,297,929 as well as WO 03/22321, WO 2008/061992, and US 2010/0048847. These patents are hereby incorporated by reference in their entireties. Silicone hydrogels may have higher shape memory than conventional contact lenses.
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 lens support.
Embodiments may include a lens support surrounded by a sealable cavity also interchangeably referred to as a chamber. The cavity may have any convenient form and may comprise a package base and at least a lid, each of which are described in detail below. As used herein, the phrases “the lid”, “a lid”, “the base” and “a base” encompass both the singular and plural. The lid and package base are sealed to each other to form a cavity which holds the contact lens, support and packaging solution in a sterile state during shipping and storage prior to use. The contact lens package is made from materials which are compatible with the contact lens and solution, as well as retortable and biologically inert.
“Film” or “multilayer film” are films used to seal the package and are often referred to as lidstock. Multilayer films used in conventional contact lens packages may be used in the packages of the present invention as the base, a component of the lid, or both. Multilayer films comprise a plurality of layers, including barrier layers, including foil layers, or coatings, seal layers, which seal the film to the rest of the package, and may also comprise additional layers selected from peel initiation layers, lamination layers, and layers that improve other package properties like stiffness, temperature resistance, printability, puncture resistance, barrier resistance to water or oxygen and the like. The multilayer films form a steam sterilizable (retortable) seal. The multilayer film can include PET, BON or OPP films layers to increase stiffness and temperature resistance, or to EVOH or PVDC coatings to improve barrier resistance to oxygen or moisture vapor.
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.
The package base may form the bottom of the package. It can be made from any material suitable for packaging medical devices, including plastic. The packaging lid generally resides at the upper portion the package and seals with the base to form a cavity containing at least a portion of the lens support, lens, and packaging solution. The lid may be made from any material suitable for packaging medical devices, including a molded sheet of foil or plastic, laminate films, or plastic. Packages comprising plastic for one structure and foil or laminated films as the other, or packages comprising foil or laminated films as the outer layer for the lid and base are known in the art and are examples of suitable combinations.
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.
With reference to the figures,
Base 110 further includes several optional finger engagement features 122a-122c to assist the user with handling the contact lens package during the opening process. A finger dimple 122a may be sized to accommodate a finger or thumb of the user is disposed at the end of the base 110 proximal to the user; an overhang 122b along a peripheral edge of the base 110; and a protrusion 122c is disposed at the end of package 118 distal to the user. Finger dimple 122a in this embodiment is also angled downward such that a force, e.g., pressure applied by a thumb of the user, causes the lever 118 to hinge downward at the pivot line 114. Package 100 in this embodiment is further configured with a profile that slopes from proximal to distal end to further encourage a downward moment at the lever, for example when the lever is pressed down or the when the package is squeezed by the user, i.e., when the user applies pressure by hand at opposing ends of the package, i.e., via a finger at one end and a thumb at the other. In this embodiment, package 100 is configured such that the squeezing forces are applied at the distal and proximal ends. However, alternative embodiments are possible whereby the opposing forces involved in squeezing are applied at alternative opposing ends of the package, such as but not limited to the sides, left and right, of the package.
In a first step shown in
As illustrated at step shown in
Turning to
In this embodiment, contact lens 138 conveniently is presented to the wearer in a convex orientation, meaning that convex side of the lens 138 is accessible to the wearer without the need to reorient the lens before placing the concave side of the lens onto the wearer's eye surface. It will be appreciated however that other orientations, such as the concave orientation of traditional blister packages, are possible within the scope of invention. Transfer of the contact lens 138 from the lens support 140 may be performed by a wearer's finger 154, either directly touching the lens or indirectly by way of an applicator film (e.g., as described in US20190046353) or other covering applied to the finger, or may be performed by another transfer means, such as a manual or automatic applicator device or tool. Upon transfer of the contact lens 138 from the package 100, the lens rests on the finger 154 (or other transfer means), as shown in step illustrated, with the convex side of contact lens 138 against the finger 154 and the concave side of the lens 138 oriented for direct application to the user's eye surface.
Turning now to
The underside of the base may be sloped, as in the embodiment illustrated, to enable the packages to “nest” thereby allowing more compact secondary packaging during storage and transport (as described further with reference to
Finger engagement feature (dimple) 122a is sized to accommodate a finger or thumb of the user is disposed at the end of the base 110 proximal to the user. Finger dimple 122a in this embodiment is also angled downward such that a force, e.g., pressure applied by a thumb of the user, causes the lever 118 to hinge downward at the pivot line 114. The position of the finger dimple position of this dimple and the finger of the user relative to the pivot line affects the amount of squeeze force necessary to cause the lever to hinge along the pivot line. In this example, the dimple depth below the pivot line is 4.5 mm when measured from the seal level to the base of the dimple.
A lens support 140 is coupled to the lever 118 so that force applied to the lever 118 causes the lens support 140 to lift the contact lens 138 out of the packaging solution. In the embodiment illustrated, lens support 140 is a separately molded (or printed) component that is fixedly attached to the lever 118 portion of the base. Attachment is made here via a stake 162 formed in the lever portion of the base material. Lens support 140 has an opening 166 corresponding to the stake 162 so that, when lens support 140 is placed onto the base, stake 162 mates with opening 166. Heat is applied using a hot plate to the stake/opening to deform the plastic material using heat and force, holding the stake securely in position like a rivet. A bond is made by partially deforming the stake 162 around opening 166. Numerous other means of attachment other than heat staking are possible within the scope of the claims, including e.g., laser welding, ultrasonic welding, adhesion, mechanical clipping, and the like. Further, it should be noted that in alternative embodiments in which the lens support may be formed as part of the same unitary molded or printed component as the lever and/or the entire base. The point of coupling/attachment of the lens support to the lever is preferably about 2 to 5 mm from the pivot line to the front of the peg/stake. In many embodiments, such as the one illustrated in which the pivot line is formed by a fold in plastic or other substantially rigid material, the pivot line may have a thickness, i.e., it may not be perfectly sharp. In these cases, such separation may be needed between the point of attachment and the pivot line in order to maximize the lifting angle for a given bend force.
The underside of a lid 106, as can be seen in
Lens facing surfaces of the present invention serve to support the lens when loaded by these forces to avoid or reduce significant optical damage. For example, gravitational forces and interactions with air bubbles in the packaging solution can result in optical damage if not properly counteracted. In one aspect, lens facing surfaces, as in the lens facing surfaces 168 of the illustrated embodiment, include a relatively large contactable surface area, at least about 3 percent and preferably at least about 20% of percent or as large as possible while still accommodating any desired air egress channels. The contactable surface area is understood to mean the area of contact between the lens and lens facing surfaces when the lens is loaded, i.e., placed into contact under an applied force, such as but not limited to gravity or air bubble interaction. The contactable surface area determines the pressure exerted on regions of the lens when/if it is loaded. The larger the area, the more the pressure is reduced. In the embodiment illustrated, the lens facing surfaces 168 have a contactable surface area of 100 mm2 conventional contact lens having a surface area of approximately 215 mm2. As discussed in more detail below, it is preferable that at least 10% of the surface area above the lens be left exposed to promote air entering the package to travel over to reduce any tendency of the lens to stick to the lens facing surfaces/lid insert.
The lens facing surfaces 168 are also spaced apart to define air egress channels 169 allow air, in particular air bubbles in the packaging solution, to travel away from the contact lens into a peripheral volume of the cavity 136. It is advantageous for the air egress channels have a positive gradient toward the peripheral volume with a vertical rise of at least about 2 mm. Air egress channels permit smaller air bubbles to escape from the area around the lens surface while simultaneously avoiding larger bubbles entering the space above the lens. Toward this end, preferred embodiments include at least two air egress channels each having a width of between about 1 mm-1.5 mm or preferably between 1.5 mm-2 mm and, specifically 1.5 mm in the embodiment illustrated. In a related aspect, air egress channels 169 advantageously form an “X” configuration. This configuration of air egress channel positions relative to each other allows, when the package is rotated in a side orientation, at least one of the channels always to have a central axis from near the center of the cavity that is angled relative a plane normal to gravity. This aspect exploits buoyancy to allow air bubbles to escape away from lens irrespective of the orientation the lens package take thus reducing the optical damage that might otherwise result, e.g., from the air bubble forcing the lens into the lens support.
Lid insert 170 is attached to an inner surface of the lid 106 in this embodiment by a heat seal between the multilayer film lid 106 and the planar surfaces 172a-d on the upper side of the lid insert. As discussed in more detail later herein, alignment of a lid insert with the base during the heat-sealing process and during storage may be aided by the inclusion of one or more alignment features in the base and/or lid insert. For example, alignment features 174 in the embodiment illustrated take the form of columns on the interior wall of cavity 136 of the base 110. The alignment features 174 resist rotation and lateral motion of the lid insert 170 when pressure is applied to seal the package 100 or during normal use. Alternative alignment features are possible such as but not limited to forming the cavity and lid insert (or integral portion of the lid comprising lens facing surfaces) in a non-circular shape such that the components interlock and resist rotation inherently.
Referring now to
Cavity 132 preferably is substantially filled with packaging solution, provided however that manufacturing processes may not permit sealing the packaging under vacuum pressure. In such cases, it is anticipated that some amount of air will become entrapped in the cavity. If these air bubbles are not managed, they may interact with the lens and cause significant optical damage to the lens. Accordingly, peripheral volumes in the cavity, i.e., volumes in the cavity that are peripheral to the location of the lens over the lens support, may be provided. Ideally, such volumes should be provided at the distal and proximal ends of the package, such as 132′ and 132″ of cavity 132 of package 100, so that the air bubbles have a place to reside regardless of the orientation of the package during transport or storage.
In one aspect, lens facing surfaces may function as air entry guides through placement and configuration that causes air that enters the package upon opening to travel over the contact lens to avoid the contact lens sticking to the lid or lens facing surfaces thereof. As illustrated in
Lens supports of the present invention may take myriad shapes and forms capable of lifting the lens out of the packaging solution when the user applies force(s) to the package, such as squeezing the package as described with respect to embodiments herein. However, as mentioned it is preferable that the lens support keeps the lens in the desired convex orientation (bowl down relative to the base) and position (centered over the support) during shipping and storage. Ideally, the lens support may provide an open structure under the lens to allow, upon opening, the packaging solution to drain from the lens and support without trapping water between the support and the underside of the lens. It is also preferable that the lens support has a sufficient number of contact points with the lens to prevent the lens from collapsing onto, rotating off or translating across the support. This allows the apex of the lens to be supported by the lens's own elastic stiffness, or to minimize sinking of the lens apex while limiting the contact area between the support and lens. Too much contact between the support and the lens after solution draining, and water trapped between the support and the lens, can create surface tension between the lens and water on and around the lens support that is greater than the surface tension between a wearer's finger and the lens, interfering with efficient lens transfer.
The sum of the contact between the lens and the lens support when the package is open, and the solution drained from the lens and lens support is the total wetted contact area, which may be less than about 30 mm2, less than 25 mm2 or less than 20 mm2 and is distributed at least around the lens periphery, as described herein. “Wetted contact area” as used herein refers to the direct solid contact area between the lens support and the lens added to the area of any menisci, reservoirs, or solution bridges that form between the lens and lens after the lens is lifted and packaging solution is allowed to drain for less than about <30 s, less than about <5 s, or less than about 2 s, depending on the intended user experience of the package.
For lenses made from polymers with longer shape memory, the lens support may be designed to limit contact between the lens and support during storage. Such contact may be distributed around the lens peripheral edge. Contact between the lens optic zone, lens support and lid interior (including any air entry guides) may be transitory or there may be no contact between the optic zone and support, lid or air entry guides. Lenses, such as conventional hydrogels, having shorter shape memory, are less prone to distortion from packaging contact, and can have the contact points distributed around the periphery and throughout the lens profile, including the lens center zone (about 9 mm, or about 5 mm diameter).
The lens supports of the present invention preferably allow, upon dabbing, both the fingertip and lens to deform to match each other's shape, without causing lens inversion or damage to lens during removal from too much pressure during dabbing. Thus, an aspect of the removal of the lens from the present packages may be to control the ratio of the contact area between the finger and lens as compared to the area between the lens and the lens support so that the contact area between the finger and lens exceeds the contact surface area of the lens support on the lens underside. This will ensure that surface tension between finger and lens exceeds surface tension between lens and lens support. Thus, the lens will adhere to the finger for lens transfer and placement onto the eye.
The lens support preferably provides at least 2, at least 3, 3 to 14, 4 to 14, 3 to 8 or 4 to 8, 4 to 6 or 6 points of contact with the contact lens edge along the peripheral supports. When two peripheral supports are used, they may be wider to provide stability, without exceeding the area of contact desired for consistent lens transfer. The peripheral points of contact prevent the lens from rotating off the lens and can be distributed in a number of configurations, in which the space between the furthest adjacent contacts is less than the diameter of the lens. As the number of peripheral supports is increased the likelihood of residual packaging solution forming films between adjacent peripheral supports and solution bridging between the support and lens may be increased during drainage. Peripheral supports with less than 50% open space such as those in the form of a screen or strainer, generally provide insufficient drainage to insure one touch transfer. Likewise, too much contact between the support and the lens after solution draining, and water trapped between the support and the lens, can create surface tension between the lens and water on and around the lens support that is greater than the surface tension between a wearer's finger and the lens, interfering with efficient lens transfer. The width of the constituent support members of the lens support vary between the limits of the selected molding process and widths necessary for efficient packaging solution drainage upon opening. Suitable widths include about 0.5 to about 1.5 mm, about 0.5 to about 1, or about 0.5 to about 0.7 mm, and it will be appreciated that lens support designs having fewer contact points may have thicker arms.
Lens supports may achieve sufficient drainage of packaging solution from the lens to enable single-touch transfer through one or a combination of drainage techniques referred to herein as channel drainage and back drainage. Channel drainage involves the formation on the lens support of channel members along which packaging solution is channeled away from the lens under the force of gravity when the lens support is lifted. Back drainage, on the other hand, refers to enhanced drainage from the underside of the lens where the lens rests on the lens support. This area underneath the apex of the lens tends to trap packaging solution due to the hydrophilicity of modern contact lens materials. Enhanced back drainage may be achieved in some embodiments by designing the lens support with a central opening beneath the apex of the lens of at least about 12 mm3.
Referring then to
The design of lens support 140 creates central opening 212 to allow the packaging solution to back drain from the lens and lens support 140 when the package is opened and the lens support lifted from the packaging solution. This allows the apex of the lens to be supported by the lens's own elastic stiffness, and to minimize sinking of the lens apex while limiting the contact area between the support 140 and lens. The design also provides sufficient support to edge of the contact less at points along the channel members 204a and 204b as well as along peripheral support 208. This configuration sufficiently reduces the wetted contact area between the lens support 140 and the contact lens to at least about 25 mm2 when measured 2 seconds after lens support 140 is lifted.
One of myriad alternative embodiments of a lens support within the scope of the invention is shown at
The design of lens support 300 includes sufficient open space between the spokes of central support 310 to allow the packaging solution to back drain from the lens and lens support 140 when the package is opened and the lens support lifted from the packaging solution. This allows the apex of the lens to be supported by the lens's own elastic stiffness, and to minimize sinking of the lens apex while limiting the contact area between the support 300 and lens. The design also provides sufficient support to the edge of the contact lens at points along the peripheral support members 328 and 330. This configuration sufficiently reduces the wetted contact area between the lens support 300 and the contact lens to at least about 25 mm2 when measured 2 seconds after lens support 300 is lifted. It must be emphasized that the lens support embodiments illustrated and described herein are merely two among of myriad embodiments of a lens support within the scope of the invention as set forth in the appended claims. To be sure, a number of additional illustrative but non-limiting exemplary lens supports are depicted in
As noted above, in one aspect contact lens packages of the present invention may be configured to allow a nested configuration.
Turning now to
An alternative exemplary method of manufacture/assembly of the exemplary contact lens package 100 is illustrated as steps 1001B, 1002B, 1003B, 1004B, and 1005. At a first step 1001B, a package base 110 is provided wherein a cavity 136 of the base 110 has lens support 140 coupled thereto. In this example, lens support 140 is coupled to the base by a heat staking process as described in more detail above. However, as noted, other means of attachment are possible within the scope of the claims, including e.g., laser welding, ultrasonic welding, adhesion, mechanical clipping, and the like. Next at a step 1002B, a contact lens 138 is placed onto a lens facing surface of a lid insert 170, in this embodiment with the lens's convex surface resting against the lens facing surfaces 168 of lid insert 170. The lens 138 may be placed onto the lid insert by manual or automated means such as through a lens transfer nozzle. Then, at a step 1003B, the lid insert 170 having the contact lens 138 resting thereon is placed onto the lens support 140 in the cavity 136 of the base 110. Next, at a step 1004B, the cavity 136 is dosed with packaging solution sufficiently to fully submerge the contact lens 138 in the 136 cavity and ideally as full as possible without overflowing the cavity. Finally, at a step 1005, the lid 106 is sealed onto the base 110, for example by heat sealing the foil to the base as described in more detail above, such that the sealing encloses the contact lens 138 and packaging solution within the cavity 136 in a sterile environment.
In some methods of manufacture/assembly of contact lens packages within the scope of the invention, the provision of packaging solution to the cavity may take place in multiple doses at different steps of the assembly process as opposed to all at once as described in the exemplary methods above. For example, in embodiments in which the lens is placed upon the lens support (e.g., step 1001A above) it may be advantageous to pre-dose a small amount of packaging solution onto lens support before resting the lens thereon so that the lens becomes secured to the lens under the surface tension of the solution. Dividing the dosing of packaging solution may also be advantageous when filling the cavity, such as, for example, by dividing a dose of approximately 2080 μL into two approximately equal sized doses for example at steps (1001B and 1004B) described above.
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 and/or single touch packaging. The breadth and scope of the present invention should not be limited by any of the above-described exemplary embodiments but should be defined only in accordance with the following claims and their equivalents.
This patent application claims the benefit of U.S. Provisional Application Nos. 63/243,525 filed Sep. 13, 2021; 63/124,835 filed Dec. 13, 2020, 63/077,779 filed Sep. 14, 2020; and U.S. Provisional Application No. 63/077,784 filed Sep. 14, 2020.
| Number | Date | Country | |
|---|---|---|---|
| 63243525 | Sep 2021 | US |
