The present invention relates to contact lens packaging and methods, and more specifically, to blister packages for sealed contact lenses containing unworn contact lenses, and methods of manufacturing contact lens packages.
Contact lenses, such as hydrogel and silicone hydrogel contact lenses, are frequently packaged in sealed blister packages or blister packs that permit storage of the unworn contact lenses in a sterile environment. For instance, a blister package which is adapted to provide a sterile sealed storage environment for a disposable or single-use hydrophilic contact lens, wherein the lens is immersed in a sterile aqueous solution, for example, such as in an isotonic saline solution, is described in Martinez, U.S. Pat. No. 4,691,820. Additional contact lens packages are disclosed in U.S. Pat. Nos. 4,691,820; 5,054,610; 5,337,888; 5,375,698; 5,409,104; 5,467,868; 5,515,964; 5,609,246; 5,620,088; 5,695,049; 5,697,495; 5,704,468; 5,711,416; 5,722,536; 5,573,108; 5,823,327; 5,704,468; 5,983,608; 6,029,808; 6,044,966; and 6,401,915.
As an example of part of a manufacturing process, a newly manufactured unworn contact lens will be placed in a cavity or well of a plastic base member of a contact lens blister package, a contact lens packaging solution will be provided in the blister package cavity, and a foil sealing member will be adhered to the blister package to hermetically seal the contact lens in the packaging solution in the cavity. In other words, a contact lens blister package used in the manufacture of contact lenses contains a base member having a cavity or well, an unworn contact lens provided in a packaging solution within the cavity, and a sealing member sealed to the base member to provide an air tight seal around the perimeter of the cavity. The sealed blister package containing the contact lens is then autoclaved to sterilize the contact lens in the packaging solution in the cavity. The blister packs are understood to be primary packaging. Multiple blister packs are then placed in cartons. The cartons are considered secondary packaging.
Contact lens packages typically require a user to place a finger in the blister package cavity or well to pinch, slide, or otherwise manipulate the contact lens so it can be removed from the cavity. The contact lens then is positioned on a fingertip so it can be placed on an eye. Handling the contact lens, however, can introduce contaminants to the surface of the lens which can then be transferred to the eye. It can be appreciated that there remains a need to improve contact lens packaging, which, among other things, minimizes or eliminates the need for touching the contact lens before it is inserted onto a user's eye.
The present invention addresses this need. As discussed herein, new contact lens packaging and methods of manufacturing packaged contact lenses are described. In general, as described herein, a contact lens package is provided. The contact lens package so described includes a plastic base member and a sealing member coupled to the base member to seal a contact lens in a cavity formed between the plastic base member and the sealing member. An unworn contact lens is provided in a contact lens packaging solution in the cavity. This sealed device is referred to herein as a sealed contact lens package or sealed contact lens blister package. The present sealed contact lens package, when opened, presents the contact lens in an orientation and posture that enables direct placement of the lens onto an eye without inverting the lens, or facilitates the placement of the lens on a fingertip for easy transfer of the lens to the surface of the eye, or both. No digging into a cavity or well or pinching of a sterile lens is required to remove the contact lens or to place the lens in a desired orientation for placement onto an eye, or both. Moreover, the present contact lens package, when opened, presents the lens in an orientation that does not require touching the inner, concave surface of the lens that, in use, directly contacts the surface of an eye.
According to an embodiment of the present invention, a blister package for a contact lens is provided, which blister package comprises a body defining a handle and a well, a flexible top contacting the body and closing the well, and a deformable slider comprising a lens support. The deformable slider is disposed between the body and the flexible top and is configured such that, by either pulling the deformable slider or peeling away the flexible top the lens support is lifted away from the bottom surface of the well and the lens is raised out of the well cradled or supported by the deformable slider.
The deformable slider can comprise a hinge connected to both the flexible top and the lens support and the blister package can be configured such that, by peeling the flexible top away from the body, the hinge is pulled taut causing the lens support to be lifted away from the bottom surface and enabling excess lens solution to drain back into the well.
The deformable slider can comprise a pull tab configured such that, after opening the blister package by peeling away the flexible top to expose the pull tab, the pull tab can be pulled to pull taut the deformable slider, lift the lens support, and enable excess lens solution to drain back into the well.
According to another embodiment of the present invention, the blister package comprises a hinged shell comprising a shell bottom, a shell top, a hinge connecting the shell bottom to the shell top, and a lateral opening along a side of the closed shell opposite the hinge. The shell bottom has a bottom inner sidewall that partially defines a bottom chamber, and a bottom chamber perimeter surface intersecting with the bottom inner sidewall. The shell top has a top inner sidewall that partially defines a top chamber, and a top chamber perimeter surface intersecting with the top inner sidewall. The hinged shell is configured such that the shell bottom and the shell top can be closed together to form the closed shell having the lateral opening. According to such an embodiment, the deformable slider is folded over onto itself at a fold, is substantially enclosed in the closed shell, and comprises a bottom surface that seals the bottom chamber and is folded-over to seal the top chamber. The deformable slider extends from the lateral opening of the closed shell. By pulling the tongue, the deformable slider can be removed from the closed shell, causing the top chamber to drain into the bottom chamber, drop the lens onto a grate above the bottom chamber, and present the lens on top of the grate so the lens can be contacted with a fingertip once the shell is opened.
Other aspects and details of the present invention will be apparent based on the following drawings, detailed description, and claims.
According to the present invention, a blister package for a contact lens is provided. The blister package comprises a body defining a handle, a well connected to the handle, and a body top surface. The well has a perimeter and an inner sidewall defining a bottom surface. A flexible top is provided contacting the body top surface around the perimeter of the well and closing the well. The flexible top has a peel tab and can be peeled away from the body to open the well. The blister package can comprise a deformable slider. The deformable slider can comprise a lens support. The lens support can comprise, for example, a dome, a hemisphere, or a pad made of, or comprising a compressible material, a foam material, an open-cell foam, a closed-cell foam, a polymeric material, a rubber material, an elastomeric material, or a combination thereof, or the like. The lens support can have a circular shape and a diameter. The lens support can be disposed in the well and adjacent to the bottom surface. The deformable slider can be disposed between the body and the flexible top. The deformable slider can be configured such that, by pulling the deformable slider, the lens support is lifted away from the bottom surface.
The deformable slider can be connected to the flexible top, the lens support, both, or neither. The deformable slider can comprise a hinge and the hinge can be connected to both the flexible top and the lens support. The blister package can be configured such that, by peeling the flexible top away from the body, the hinge is pulled taut causing the lens support to be lifted away from the bottom surface and enabling excess lens solution to drain back into the well. The peel tab of the flexible top can contact the body on a first side of the well, and the hinge can be connected to the flexible top adjacent a second side of the well, for example, wherein the second side is opposite the first side. The blister package can be configured such that, by peeling the flexible top away from the body, the well is exposed prior to the hinge being pulled taut. Pulling the flexible top in a direction from the first side to the second side can cause the lens support to be lifted away from the bottom surface.
The deformable slider can comprise a unitary sheet of material, a multi-layer sheet of material, a foil material, a plastic material, a combination thereof, or the like. The deformable slider can comprise a foil material. Each of the flexible top and the deformable slider can independently comprise a foil material. The material of the flexible top and the material of the deformable slider can be the same or can be different. The deformable slider can be a part of or separate from the flexible top. The blister package can be configured such that peeling away the flexible top from the body can expose the deformable slider.
The deformable slider can further comprise a pull tab. The flexible top can be sealed to the body top surface with the pull tab sealed between the body top surface and the flexible top, or the pull tab can be exposed when the flexible top is sealed to the body top surface. The pull tab can be configured such that, after opening the blister package by peeling away the flexible top, the pull tab can be exposed. Pulling the pull tab can pull taut the deformable slider, uncover, release, or otherwise cause a lifting of the lens support, and enable excess lens solution to drain back into the well. The pull tab can comprise a rail, the body can comprise a groove, and the rail can be slidable in the groove. Pulling the pull tab can comprise sliding the rail of the pull tab in the groove.
The blister package can comprise a contact lens in the well and supported by the lens support. Contact lens solution can also be included in the blister package, for example, a sterile, packaging solution such as a saline solution.
The present invention also provides a method of packaging a contact lens. The method comprises placing a contact lens into a well of a blister package, on top of a lens support of a deformable slider. The blister package can comprise a body having a handle, a well connected to the handle, and a body top surface. The well can have a perimeter and an inner sidewall defining a bottom surface. An exemplary blister package that can be used in carrying out the method is a blister package of the present invention, for example, as described above. The method can comprise sealing a flexible top to the body top surface to seal the well with the contact lens therein, on top of the lens support. The step of sealing can comprise sealing the flexible top such that the flexible top contacts the body top surface around the perimeter of the well and closes the well. The flexible top can have a peel tab that can be peeled away from the body to open the well. The lens support can be disposed in the well and adjacent the bottom surface. The deformable slider can be configured such that, by pulling the deformable slider, the lens support is lifted away from the bottom surface.
The deformable slider can comprise a hinge. The deformable slider can be folded over on itself and the hinge can be defined by the fold. The hinge can be connected to the both the lens support and to the flexible top. The method can comprise pulling the pull tab and pulling the pull tab can result in any of a number of actions. Pulling the pull tab can (1) peel the flexible top away from the body top surface. Pulling the pull tab can (2) open the well. Pulling the pull tab can (3) pull taut the hinge. Pulling the pull tab can (4) lift the lens support away from the bottom surface and enable excess lens solution to drain back into the well. Moreover, pulling the pull tab can result in all four actions ((1)-(4)) being carried out.
The method can further comprise opening the blister package by peeling away the flexible top and pulling taut the deformable slider to lift the lens support and cause excess lens solution to drain back into the well. If the deformable slider is connected to the flexible top, the method can further comprise pulling the pull tab to peel away the flexible top from the body top surface, lift the lens support away from the bottom surface of the well, and enable excess lens solution to drain back into the well.
The deformable slider can comprise a pull tab. The step of sealing the flexible top to the body top surface can comprise sealing the pull tab between the body top surface and the flexible top. The method can further comprise opening the blister package by peeling away the flexible top and pulling the pull tab to pull taut the deformable slider and lift the lens support. Pulling taut the deformable slider can lift the lens support and enable excess lens solution to drain back into the well. The pull tab can comprise a rail and the body can comprise a groove. The rail can be slidable in the groove, and the step of pulling the pull tab can comprise sliding the rail of the pull tab in the groove.
In yet another embodiment of the present invention, a blister package for a contact lens is provided, which comprises a hinged shell. The hinged shell can comprise a shell bottom, a shell top, and a hinge connecting the shell bottom to the shell top. The shell bottom, shell top, and hinge can be formed together as one piece, for example, integrally molded together, or the shell bottom and shell top can be made separately and joined together by the hinge, for example, with one of the top and bottom comprising a connected rail and the other of the top and bottom comprising an open groove for receiving the rail. The shell bottom can have a bottom inner sidewall that partially defines a bottom chamber, and a bottom chamber perimeter surface intersecting with the bottom inner sidewall. The shell top can have a top inner sidewall that partially defines a top chamber, and a top chamber perimeter surface intersecting with the top inner sidewall. A contact lens can be sealed within the top chamber. The hinged shell can be configured such that the shell bottom and the shell top can be closed together to form a closed shell having a lateral opening.
Together with the hinged shell, the blister package can comprise a deformable slider. The deformable slider can comprise a foil material, a plastic material, a unitary sheet of material, a combination thereof, or the like. The deformable slider can be folded over onto itself at a fold. The deformable slider can be substantially disposed, enclosed, or encased within the closed shell. The deformable slider can comprise a bottom surface sealing the bottom chamber at the bottom chamber perimeter surface, be folded over onto itself, and seal the top chamber at the top chamber perimeter surface. The deformable slider also comprises a tongue extending from the lateral opening of the closed shell. A lens support can be provided in the bottom chamber, for example, a grate extending across a top of the bottom chamber. In use, by pulling the tongue to remove the deformable slider from the hinged shell, through the lateral opening, the seals (1) between the deformable slider and the top chamber perimeter surface, and (2) between the deformable slider and the bottom chamber perimeter surface, can be broken and the deformable slider can be peeled away from and out of the hinged shell. Liquid contents in the top chamber can then flow or drain into the bottom chamber and, when the shell is opened, the contact lens can be supported by the lens support at the top of the bottom chamber. The contact lens is presented in an orientation ready to be contacted by a fingertip of a user and transferred onto an eye.
A contact lens and lens solution can be sealed within the top chamber. The lens support can comprise a drain and the blister package can be configured such that, by pulling the pull tab out of the closed shell, through the lateral opening, the seal between the deformable slider and the top chamber perimeter surface is broken. The seal between the deformable slider and the bottom chamber perimeter surface is also broken. The contact lens solution can then be drained from the top chamber into the bottom chamber. The closed shell can then be opened to present the contact lens on the lens support above the bottom chamber.
According to the present invention, a contact lens can be positioned or disposed in the top chamber, along with contact lens solution, for example, while the top chamber is in an inverted or upside-down orientation. The deformable slider can then be sealed to the top chamber perimeter surface and to the bottom chamber perimeter surface, to form a sealed blister package. The shell bottom and the shell top can then be closed together to form a closed shell having a lateral opening. To open the blister package, the deformable slider can be pulled out of the lateral opening by pulling on the tongue, and then the hinged shell can be opened. The lens support can comprise a drain and the method can further comprise draining the contact lens solution out of the top chamber. The action of pulling the pull tab out of the closed shell, through the lateral opening, can (1) break the seal between the deformable slider and the top chamber perimeter surface, (2) break the seal between the deformable slider and the bottom chamber perimeter surface, and (3) drain the contact lens solution into the bottom chamber. The closed hinged shell can then be opened, presenting the contact lens on the lens support at the top of the bottom chamber.
The blister package body includes a well for containing a contact lens immersed in an amount of a solution. The term “contact lens” as used herein is intended to embrace an ophthalmic lens which is to be worn on or in the eye of an individual. The top surface of the body includes a peripherally located perimeter region at least partially surrounding an opening of the well. The handle can include a grip region. The flexible top is designed to cover and sealingly enclose the contact lens and solution within the well.
The body of the blister package can be formed of a plastic material that can be shaped by injection molding or thermoforming. For example, the plastic material used to make the body can comprise polypropylene, polyethylene, polystyrene, or another thermoplastic material. One or more portions of the body material, particularly in the well, can have a vapor transmission of less than 10 grams/100 square inches/24 hours at 70° F. and 50 percent relative humidity.
As stated above, the body of the blister package can comprise a variety of structures, such as a relatively rigid material or a flexible material. The base member of the sealed blister package can be a thermoplastic material or an injection molded material, and the base member can include a well and a substantially planar body top surface surrounding the well. The substantially planar body top surface provides a sealing surface for sealing the flexible top. The body can be made from a variety of materials. The body can be formed using conventional methods and equipment, such as by injection molding polypropylene resin into body molds in an injection molding machine. The flexible top can also be formed from a variety of materials. For example, the flexible top can be a laminated structure comprising a foil and one or more layers of plastic, such as polypropylene and the like. The flexible top can include human readable information, as desired. The flexible top can be coupled to the body top surface by contacting the sealing surface of the body with the flexible top and applying heat to fuse the two members together to provide a hermetic or airtight seal for the contact lens and the packaging solution in the well.
The perimeter of the well can be contiguous with the circumference of the well. The perimeter can include a flange region, for example, extending about 5 mm from the opening of the well to a grip region. In an exemplary embodiment, the overall dimensions of the blister package can be approximately 30 mm wide, about 47 mm long and about 10 mm high. It should be appreciated, however, that the package can have any size and/or shape.
The well holds in a fluid tight manner, a contact lens and solution. The well is bounded by a seal area that is part of the flange region. The flexible top can be attached to the body by heat-sealing in the seal area; however, induction-sealing, sonic welding, or other bonding systems can be used to attach the flexible top to the body. The total interior volume defined by the well, once sealed, can be about 2.2 ml or less. The total interior volume can be, for example, from about 0.5 ml to about 2.5 ml.
The flexible top can comprise at least two elements, for example, at least two different, separate layers of material. For example, the flexible top can comprise a first member, or first layer, and a second member, or second layer overlaying the first member. The first member can be made of a laminate material that is heat sealed to the seal region of the blister package body. The second member can comprise a foil material, sealed to the rim portion of the body. The second member can comprise at least one, for example two, polymer layers, e.g. polypropylene, coating the foil. The foil can comprise aluminum. The polymer coating material on the heat seal side of the foil can be polypropylene. Examples of useful cover layers are described in U.S. Pat. No. 4,691,820 that is incorporated herein in its entirety by reference. The second member can be sealed to the body along an entire circumference of the body surrounding the well, so as to provide a sanitary or sterile covering, for example, by means of a hermetic seal.
The deformable slider can comprise one, two, or more different, separate layers of material. The deformable slider can be made of a laminate material. The deformable slider can comprise a polymer or polymer layer, a homopolymer layer, polypropylene, polyethylene, another polyalkylene, an elastomeric material, a silicone rubber, a vulcanized rubber material, a rubber band material, a foil layer, a combination thereof, or the like.
The deformable slider can be configured to stretch across the well, for example, from a proximal side of the well, adjacent to the handle, to a distil side of the well, opposite the proximal side. The deformable slider can be configured to be pulled taut from a beginning, relaxed position into a lifted, stretched-out position whereby a contact lens in the blister package body is raised out of the well and presented. The deformable slider can be attached to the proximal side of the well, attached to the distal side of the well, or both. The deformable slider can be attached across any two sides or portions of the sidewall of the well. By attachment to the side of the well, what is meant is attached to an inner sidewall portion of the well, to an edge of the well adjacent to the well opening, to the top surface of the blister package body at or near an edge of the well, or a combination thereof.
The deformable slider can be, and remain during use, attached at an end to the distal side of the well, while an opposite end of the deformable slider, adjacent to the proximal side of the well, is pulled taut. Pulling taut can involve, for example, being slid laterally such as toward the handle. For example, the deformable slider can be tensioned by the action of pulling a pull tab operatively connected to the deformable slider. The deformable slider can be adhered to, bonded to, formed integral with, attached to, or otherwise affixed to the pull tab. Movement, for example, sliding movement, lateral movement, or the like, can affect tensioning of the deformable slider. The deformable slider can be, and remain during use, attached to the proximal side of the well and can be pulled taut by movement at or adjacent to the distal side of the well. For example, the deformable slider can be tensioned by the action of pulling away the flexible top from the top surface of the blister package body.
The deformable slider can be pulled taut so as to rise up from the bottom of the well, by being pulled in any direction. For example, the deformable slider can be pulled taut by movement of a proximal end of the deformable slider toward the handle, by movement of a distal end of the deformable slider away from the handle, by movement transversely across the well or orthogonally relative to the longitudinal axis of the blister package, by a combination thereof, or the like.
An unworn contact lens is sealed within the well of the sealed contact lens blister package and is packaged in a contact lens packaging solution. Any contact lens can be packaged therein. For example, the contact lens can be a hydrogel contact lens or it can be a silicone hydrogel contact lens. Examples of contact lenses that can be provided in the packages include those having the following United States Adopted Names (USANs): methafilcon A, ocufilcon A, ocufilcon B, ocufilcon C, ocufilcon D, omafilcon A, omafilcon B, comfilcon A, enfilcon A, stenfilcon A, fanfilcon A, etafilcon A, senofilcon A, senofilcon B, senofilcon C, narafilcon A, narafilcon B, balafilcon A, samfilcon A, lotrafilcon A, lotrafilcon B, somofilcon A, riofilcon A, delefilcon A, and the like.
The fluid medium or solution contained in the well (i.e., the packaging solution) can be any known solution useful for storing contact lenses including water, saline solutions, or buffered aqueous solutions. The contact lens and solution will preferably fill at least 50 percent, for example, at least 70 percent or at least 80 percent, of the total volume defined by the well once sealed by the flexible top.
The contact lens packaging solution is typically a buffered saline solution, such as a phosphate buffered saline solution or a borate buffered saline solution, that can contain one or more additives, such as surfactants, wetting agents, viscosity agents, and the like.
The blister package can also include a wrap that has one or more panels. The wrap can be dimensioned to accommodate the sealed contact lens package and to also provide a UDI in both human readable form and machine readable form, in addition to other required regulatory information. As used herein, a UDI is a “Unique Device Identifier”. As used herein, a wrap refers to a substrate or article comprising one or more panels coupled to a sealed contact lens package, and a UDI in both human readable form and machine-readable form is provided on at least one of the panels. Such a wrap can be understood to be a “UDI wrap”, or it can be understood to be a wrap having a “UDI panel”. Thus, the wrap includes human readable information, such as letters, numbers, and images; and the wrap includes machine readable information, such as bar codes and the like. The wrap can be flexible or rigid and does not need to fully enclose or surround the individual sealed contact lens package. The wrap is coupled to the sealed contact lens package so that the wrap and sealed contact lens package do not become separated until a person opens the package to remove the unworn contact lens. For example, the wrap can be adhered to the sealed contact lens package, such as by using an adhesive between a surface of the wrap and a surface of the sealing member, or the wrap can be physically wrapped around the sealed contact lens package to mechanically enclose the sealed contact lens package within the wrap. Thus, the wrap cannot be inadvertently dislodged or separated from the sealed contact lens blister package.
Examples of blister package materials, methods of making blister package bodies, flexible tops, methods of making flexible tops, methods of sealing flexible tops to bodies, as well as other helpful components, materials, methods, and systems are described, for example, in U.S. Pat. Nos. 6,398,018, 7,426,993 B2, and 7,477,366 B2, in U.S. Patent Application Publications Nos. US 2012/0061260 A1, and US 2017/0096272 A1, and in WO 2013/160667, each of which is incorporated herein in its entirety by reference.
With reference to the drawing figures, each of
With particular regard to
In both
As can be seen, pull tab 60 can be pulled toward handle 34, causing deformable slider 40 to be pulled taut such that contact lens 50, resting on deformable slider 40, is elevated out of well 32. As shown all the way to the right in
As can best be seen by the enlarged view of
Each of
With particular regard to
As can be seen in
Through the steps sequentially depicted in each of
To the far left of both
As mentioned above, shell top 324 and shell bottom 326 are joined together at a deformable hinge 360. Shell top 324 and shell bottom 326 snap together to maintain a closed shell via a friction fit between an outer periphery 341 of the ridge that defines perimeter 343 of well 345, and inner surfaces 351 and 353 of ridges 355 and 357, respectively, formed on upper surface 349 of bottom shell 326.
In use, deformable slider is pulled out through lateral opening 328 and removed from the closed shell. Once deformable slider is pulled out of lateral opening 328, as shown in the third and fourth states from the left in
The present invention includes the following aspects/embodiments/features in any order and/or in any combination:
1. A blister package for a contact lens, the blister package comprising:
The present invention can include any combination of these various features or embodiments above and/or below as set-forth in sentences and/or paragraphs. Any combination of disclosed features herein is considered part of the present invention and no limitation is intended with respect to combinable features.
The entire contents of all references cited in this disclosure are incorporated herein in their entireties, by reference. Further, when an amount, concentration, or other value or parameter is given as either a range, preferred range, or a list of upper preferable values and lower preferable values, this is to be understood as specifically disclosing all ranges formed from any pair of any upper range limit or preferred value and any lower range limit or preferred value, regardless of whether such ranges are separately disclosed. Where a range of numerical values is recited herein, unless otherwise stated, the range is intended to include the endpoints thereof, and all integers and fractions within the range. It is not intended that the scope of the invention be limited to the specific values recited when defining a range.
Other embodiments of the present invention will be apparent to those skilled in the art from consideration of the present specification and practice of the present invention disclosed herein. It is intended that the present specification and examples be considered as exemplary only with a true scope and spirit of the invention being indicated by the following claims and equivalents thereof.
This application is a continuation application of U.S. patent application Ser. No. 16/737,937, filed Jan. 9, 2020, which in turn claims the benefit under 35 U.S.C. § 119(e) of prior U.S. Provisional Patent Application No. 62/845,358, filed May 9, 2019, and U.S. Provisional Patent Application No. 62/795,288, filed Jan. 22, 2019, which are incorporated in their entirety by reference herein.
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Number | Date | Country | |
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20220142316 A1 | May 2022 | US |
Number | Date | Country | |
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62845358 | May 2019 | US | |
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Number | Date | Country | |
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Parent | 16737937 | Jan 2020 | US |
Child | 17579622 | US |