CN115697131A - One-touch contact lens package - Google Patents
- ️Fri Feb 03 2023
Detailed Description
The present invention relates to packages for contact lenses, such as hydrogel contact lenses, that allow a user to remove a contact lens from the package by contacting the contact lens at or near its apex with a fingertip. Once transferred to the fingertips, the lens is in a position suitable for placement on the eye by the wearer, thereby simplifying removal of the lens from the package and insertion on the eye.
As used herein, the following terms have the foregoing meanings.
The lens packages of the present invention are beneficial in that they provide consistent one-touch lens transfer from the package to the wearer's fingers and then from the fingers to the wearer's eyes without inverting, dropping or further manipulating the lenses. Consistent lens transfer includes a transfer rate of at least about 70%, at least about 80%, or at least about 90% upon a first touch (or "tap") of a finger. The lens also ideally "sits" on the finger without collapsing or inverting, and then transfers to the eye when placed there. The package of the present invention can provide a desired one-touch transfer across a range of finger sizes and tap pressures. Environmental conditions such as temperature and whether the finger is wet or dry may also affect transfer rate, with higher temperatures generally improving lens transfer. Lens transfer evaluated in the present invention was performed at room temperature.
Contact lenses refer to ophthalmic devices that reside on the eye. They have a generally hemispherical shape and can provide optical correction, cosmetic enhancement, UV blocking and visible light or glare reduction, therapeutic effects, including wound healing, drug or nutraceutical delivery, diagnostic assessment or monitoring, or any combination thereof. The term lens includes soft hydrogel contact lenses, which are typically provided to the consumer in a package in a hydrated state, and have a relatively low modulus, which enables 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 polymer system that contains water in an equilibrium state and may contain at least about 25% or at least 35% water in a hydrated state. Hydrogels are generally oxygen permeable and biocompatible, making them excellent materials for the production of contact lenses.
Conventional hydrogel contact lenses do not contain silicone-containing components and typically have higher water content, lower oxygen permeability, modulus, and shape memory than silicone hydrogels. Conventional hydrogels are prepared from a monomer mixture that primarily contains hydrophilic monomers such as 2-hydroxyethyl methacrylate ("HEMA"), N-vinyl pyrrolidone ("NVP"), or polyvinyl alcohol. The formation of conventional hydrogels is disclosed in U.S. Pat. nos. 4,495,313, 4,889,664, and 5,039,459. Conventional hydrogels may be ionic or non-ionic and include polymacon, etafilcon, nelfilcon, ocufilcon lenefilcon, and the like. These conventional hydrogel materials typically have oxygen permeabilities of less than 20 barrers to 30 barrers.
Silicon hydrogel formulations include balafilcon samfilcon, lotrafilcon A and B, delfilcon, galyfilcon, senofilcon A, B and C, narafilcon, comfilcon, formifilcon, riofilcon, fanfilcon, stenfilcon, somofilcon, kalifilcon, and the like. By "silicone hydrogel" is meant a polymeric network made from at least one hydrophilic component and at least one silicone-containing component. The silicone hydrogel may have a modulus in the range of 60psi-200psi, 60psi-150psi, or 80psi-130psi, a water content in the range of 20% to 60%. Examples of silicone hydrogels include acquafilcon, asmofilcon, balafilcon, comfilcon, delefilcon, enfilcon, fanfilcon, formifilcon, galyfilcon, lotrafilcon, narafilcon, riofilcon, samfilcon, senofilcon, somofilcon, and sten, including all variants thereof, and as described 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, 7,880,553, 7,666,921, 7,786,185, 7,956,131, 8,022,158, 8,273,802, 8,399,538,538, 8,999,999 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, and the silicones prepared in WO 03/22321, WO 2008/061992 and US 2010/0048847. These patents are hereby incorporated by reference in their entirety. The silicone hydrogel may have a higher shape memory than conventional contact lenses.
Hydrogel lenses are viscoelastic materials. Contact lenses can develop optical distortion if the lens interacts with the package or any air bubbles in the package. The degree of optical distortion and the length of time required for distortion relaxation will depend on the chemical composition and to a lesser extent on the geometry of the lens. Conventional lens materials, such as poly (hydroxyethyl methacrylate) -based lenses like etafilcon a or polymacon, have lower loss modulus and loss tangent values than silicone hydrogels, and may form less and less severe optical distortion due to contact with the package. The viscoelastic properties of the lenses can be altered by the incorporation of silicones (which typically increase the overall elastic response), wetting agents (such as PVP) (which typically increase the viscous response), or conventional hydrogel material coatings (which may reduce the elastic response at the lens interface). Conventional hydrogel contact lenses and silicone hydrogel contact lenses having short or hard crosslinkers and/or hardeners have short shape memory and may be less prone to deformation during storage. As used herein, a high or higher shape memory hydrogel exhibits an optical deformation of at least about 0.18 upon contact with a blister or package after 5 weeks of accelerated aging at 55 ℃. Dynamic mechanical analysis can be used to measure viscoelasticity, including loss modulus and loss tangent.
The contact lens may be of any geometry or diopter and has a generally hemispherical shape, with a concave posterior side that rests on the eye in use and a convex anterior side that faces away from the eye and is contacted by the eyelid during blinking.
The center of the lens is the center of the optical zone of the lens. The optical zone provides optical correction and may have a diameter between about 7mm and about 10 mm. The lens periphery or lens edge is the edge where the anterior and posterior sides meet.
A wet lens is a contact lens and any residual packaging solution that adheres to the packaging solution after it drains. The wetting contact is the total contact area between the wetting lens and the lens support.
The contact lens package includes a lens support surrounded by a reversible sealable chamber. The chamber may have any convenient form and may include a package base, which may have one or more compartments or base sections, a lens support, and at least one cover, each of which will be described in detail below. As used herein, the phrases "the cover," "the lid," "the base," and "the base" encompass both the singular and the plural. The lid and package base are sealed to each other to form a cavity that maintains the contact lens, support, and packaging solution in a sterile condition during shipping and storage prior to use. Contact lens packages are made from materials that are compatible with contact lenses and solutions, as well as retortable and bio-inert.
A "film" or "multilayer film" is a film used to seal packages, and is commonly referred to as a lidstock. The multilayer films used in conventional contact lens packages can be used in the packages of the present invention as components of bases, lids, or both. The multilayer film comprises a plurality of layers, including a barrier layer, including a foil layer, or a coating layer, a sealing layer, which seals the film to the rest of the package, and may further comprise additional layers selected from peel-initiation layers, lamination layers, and layers that improve other packaging properties (e.g., stiffness, temperature resistance, printability, puncture resistance, barrier to water or oxygen, etc.). The multilayer film is formed into a steam sterilizable (retortable) seal.
The multilayer films may include PET, BON, or OPP film layers to increase stiffness and temperature resistance, or EVOH or PVdC coatings to improve oxygen or moisture barrier.
The packaging solution is any physiologically compatible solution that is compatible with the material and packaging of the lens selected. The packaging solution includes a buffered solution, such as a buffered saline solution, having a physiological pH. The packaging solution may contain known components including buffers, pH and tonicity adjusting agents, lubricants, wetting agents, nutraceuticals, pharmaceuticals, packaging coating components, and the like.
The package base may form the bottom of the package. The packaging base can be made of any material suitable for packaging medical devices, including flat foil or plastic sheets, laminated films, or plastics. The bottom of the lens support is arranged on and supported by a base surface facing the packaging cavity. The lens support may also be integral with the base. The lens support may rest on an inner surface of the package base, which may be horizontal or may be angled to maintain the lens support and lens in an angled position when the bottom of the base is horizontal. When the base is disposed at an angle, the angle is preferably at least about 15 °, at least about 20 °, about 20 ° to about 80 °, about 20 ° to about 60 °, or about 20 ° to about 40 ° relative to horizontal.
A package cover forms the uppermost structure of the package and is sealed to the base to form a cavity containing the lens support, lens, packaging solution, and any other incorporated packaging features. The cap may be made of any material suitable for packaging a medical device, including flat or molded foil or plastic sheets, laminated films, or plastics. Packages comprising plastic for one structure and foil or laminate film as another structure or comprising foil or laminate film as outer layer of lid and base are known in the art and are examples of suitable combinations.
Lens support and transfer
The lens support maintains the lens in a desired convex orientation (downward relative to the base bowl) and position (centered on the support) during transport and storage. The lens support is designed to provide an open structure under the lens bowl to allow the packaging solution to drain from the lens and support when opened without trapping water between the supports; and a sufficient number of contact points with the lens to prevent the lens from collapsing onto the support, rotating off of the support, or translating through the support. This allows the apex of the lens to be supported by the elastic stiffness of the lens itself, or minimizes sag of the lens apex while limiting the contact area between the support and the lens. The support and lens are in excessive contact and pooling of water between the support and the lens after the solution has drained can create a surface tension between the lens and water on and around the lens support that is greater than the surface tension between the wearer's finger and the lens, thereby interfering with the effective transfer of the lens. Contact between and from the lens and lens support when the package is openedThe sum of the solutions discharged is the total contact area, which may be less than about 20mm 2 Less than 18mm 2 Or less than 15mm 2 And are distributed at least around the periphery of the lens, as described herein.
For lenses made of polymers with longer shape memory, the lens support can be designed to limit contact between the lens and the support during storage. Such contact may be distributed around the peripheral edge of the lens. Contact between the lens optic zone, the lens support and the interior of the cover (including any air intake guides) may be temporary or there may be no contact between the optic zone and the support, cover or air intake guides. Lenses, such as, for example, conventional hydrogels, have shorter shape memory, are less prone to deformation by package contact, and may have contact points distributed around the periphery and throughout the lens contour, including the lens central zone (about 9mm or about 5mm diameter).
The lens support of the present invention allows both the fingertips and the lens to deform to match each other's shape upon tapping without causing the lens to invert or damage during removal due to excessive pressure during tapping. Thus, one aspect of removing a lens from a package of the present invention is to control the ratio of the contact area between the finger and the lens compared to the area between the lens and the lens support such that the contact area between the finger and the lens exceeds the contact surface area of the lens support on the underside of the lens. This will ensure that the surface tension between the finger and the lens exceeds the surface tension between the lens and the lens support. Thus, the lens will adhere to the finger in order to transfer and place the lens on the eye.
Fig. 1A to 1P show examples of lens supports that can be used in the present invention. Each of these lens supports can be used in any of the packages described herein. The lens support may provide a light resistance on the lens during lens transfer to allow the lens to adhere to the fingers. As shown in fig. 1A to 1P, the lens support may be designed in various configurations. It should be understood that the configurations depicted herein are illustrative examples. Configurations not shown, or configurations incorporating aspects of the exemplary configurations depicted, are possible within the scope of the appended claims, as will be apparent to those skilled in the art in view of the balance of this disclosure.
The lens support 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 contact points along the
peripheral support105 with the edge of the contact lens. When two peripheral supports are used, they can be wider to provide stability without exceeding the contact area required for consistent lens transfer. The peripheral contact points prevent the lens from rotating off the lens and can be distributed in a variety of configurations where the space between the furthest adjacent contacts is less than the diameter of the lens. In embodiments where three contact points are used, these contact points may be arranged in an acute triangular shape as shown in example 16. All (fig. 1B, 1C, 1H, 1K, and 1L) or most (fig. 1M-1O) of the peripheral supports may be evenly distributed around the lens periphery. As the number of peripheral supports increases, the likelihood of residual packaging solution forming a film between adjacent peripheral supports and solution bridging between the supports and the lens during draining may increase. Peripheral supports having less than 50% open space, such as supports in the form of screens or filters, often provide insufficient drainage to ensure a touch transfer.
Fig. 1G shows a lens support comprising 6 planar
peripheral supports105 that engage at the center of the lens support and extend outward to the unsupported distal end.
Channel member115 is one structure that may be used to help facilitate drainage of the packaging solution, and is discussed in detail below.
The
peripheral support105 provides a path for the packaging solution to drain from the lens when the package is opened. To facilitate drainage of the packaging solution, the peripheral support is generally transverse to the lens edge, which helps prevent the lens from wrapping around the support, is linear, and may extend outwardly beyond the contact lens peripheral edge by a distance of at least 1mm. If the distal end of the peripheral support extends less than 2mm beyond the lens edge, the packaging solution may undesirably become trapped under the lens, potentially interfering with effective lens transfer. If the central peripheral ends (such as the "V" shaped notches of the
peripheral support105 in fig. 1D) are not connected to the central support, they may extend at least about 3mm from the point of contact with the lens toward the center of the support, as shown in the exemplary configuration of fig. 1D. If the peripheral support extends less than 3mm from the lens contact point towards the lens, the lens may slip off the peripheral support.
The
peripheral support105 may be disposed radially about the center of the support. They may be connected to each other as shown in fig. 1G, or at an
elbow104 as a distal portion of the lens support arm as shown in fig. 1A and 1B. The
peripheral support105 may extend inwardly from at least a portion of the
peripheral ring109, as shown in fig. 1C and 1D. Also, the
peripheral support105 may be connected to a central post or
cylinder107 as shown in FIG. 1E, or any combination of the foregoing. When the perimeter supports extend inward, they may meet at a single center point (fig. 1G), post, or cylinder 107 (fig. 1E). One or more of the
peripheral supports105 meet adjacent peripheral supports to form an open center as shown in fig. 1D. Alternatively or additionally, one or more
peripheral supports105 may extend inwardly from their distal ends at least partially at the peripheral ring to an unsupported proximal end within the circumference of the lens or to another point on the peripheral ring, as shown in fig. 1C. The peripheral support may be planar, as shown in fig. 1B-1G, or may be angled, as shown in fig. 1A. When angled, the angle may be from 0 ° to about 30 ° or 0 ° to about 15 ° from horizontal and may be inclined towards the distal end of the central or peripheral support of the support.
The distal ends of adjacent perimeter supports 105 may be connected to one another via terminal rails that form a partial perimeter ring 109 (as shown in fig. 1B and 1D) or a full ring 109 (as shown in fig. 1C). For example, fig. 1D shows a lens support comprising a partial
peripheral ring109 having a planar
peripheral support105 in the shape of an open, six-armed star disposed radially around the center of the lens support.
When included, the full or partial peripheral ring can have a diameter at least 4mm greater than the contact lens (at least 2mm from all contact lens edges) to facilitate drainage of the packaging solution from the lens and lens support. For a partial peripheral ring having a complex shape, such as the partial peripheral ring of fig. 1D, the diameter of the at least partial peripheral ring can be centered around the center of the lens support and measured across the opposing partial
peripheral ring segment109. A peripheral ring diameter of between about 16mm and about 25mm, between about 18mm and about 25mm, or between about 18mm and about 24mm will be suitable for commercially available contact lenses.
When included, the peripheral ring may rest on the base during storage, may be fixedly attached to the base, or may be attached to a vertical support, such as a foot, a
post110 as shown in fig. 1K, a raised base fin section as shown in fig. 1L, a central post or cylinder that holds the peripheral ring raised from the base. The vertical supports may extend from about 4mm to about 5mm from the base for horizontally disposed lens supports, or may extend from about 2mm to about 5mm, about 2.5mm to about 5mm, or about 3mm to about 4mm from the base for tilted lens supports when the package is closed, such as the tilted lens supports depicted in fig. 1H. When vertical supports are included, the vertical supports may be the same length or may be of different lengths to maintain the lenses at an angle relative to horizontal. The upper limit of the height of the vertical supports is limited by the desired size of the package, since increasing the length of the vertical supports increases the height of the entire package and the amount of solution required. The peripheral ring may also be attached to a lifting or pivoting structure, such as a lever or extended channel member, as described below, to facilitate lifting the lens support from the base to assist in draining the packaging solution from the lens.
The package base may also be designed such that the perimeter supports 105 (shown as part of the raised fins in the exemplary embodiment of fig. 1H) are flush with each other, but the base
bottom plate120 and the
lens support136 are disposed at an angle (fig. 1H). The lens support may be a separate structure or may be part of the base, as shown in FIG. 1H.
The lens support may further include at least one locating feature (not shown) to prevent horizontal translation of the lens through the lens support, particularly for supports that are disposed at an angle in the package or upon opening and removal. These positioning structures may include: notches, pins or stops along the peripheral support outside the lens periphery; an open center support (described below); a locator pin or tab on the inside of the lens near the periphery of the lens, wherein the angle of the lens surface is steeper, such as outside the central area of the lens (diameter about 5mm, about 6mm, or about 7 mm); or a combination thereof.
As shown in fig. 1E, 1J, and 1H, the lens support may further include an open structure central support to provide additional resistance, drainage paths, and/or to increase the contact area between the finger and the lens during lens transfer. The central support may be contoured to maintain the lens in a convex position during shipping and storage, preferably centered on the support without significant contact, and to provide the desired lens contact area after drainage and before contact by the user's fingers. The center support can be configured such that a gap is created between the lens support and the lens, such as by having a substantially flat top that allows the top of the lens to be deformed by fingers and the finger pads to flatten, creating a desired offset in the surface area. When present, the central support may be flat or may be slightly concave, preferably providing at least 0.5mm between the lens vertex and the top of the central support (to minimize contact between the lens vertex and the support) and providing a lens-finger contact area greater than the contact area between the lens and the rest of the lens support ("substantially flat top" or "flat top") when draining. If slightly curved, the center support may have a slightly concave curve with a radius of curvature of at least about 10mm or at least about 6mm, or more desirably a slightly convex curvature of about 10mm or higher. It may be desirable to design the center support so that it does not contact the lens optic zone prior to lens transfer.
The top of the center support may have a diameter of about 1mm to about 10mm, about 3mm to about 9mm, about 5mm to about 9mm, or about 6mm to about 9mm. For center supports having a flat top area of less than about 5mm in diameter, additional locating structures may be required. The center support top can be oriented parallel to the lens periphery to form a post as shown in fig. 1A-1F. The center support top also provides resistance to the fingers when the user presses down on the apex of the lens to begin lens transfer.
The central support may be formed from a plurality of arms. The arms may form a flat
top section101 and be supported by one or
more posts108 extending upwardly from the base, as shown in fig. 1J; at least one
peripheral support105, as shown in fig. 1A, 1B, 1C, 1E, 1F; at least one arm, as shown in FIG. 1D; either the
vertical supports110 in the form of fins, as shown in FIG. 1H, or the
open supports110, as shown in FIG. 1K. When the arms extend beyond the flat top, they may include an
optional side section103, a
shoulder transition102 connecting the
flat top101 and the
optional side section103, a
peripheral support105, and an
optional elbow transition104 connecting the
optional side103 and
peripheral support105. The flat top sections of the arms may be connected at a
center point106, as shown in fig. 1A and 1B;
posts108, as shown in FIG. 1 i; a ring; or may be attached to an open full or
partial cylinder107 as shown in fig. 1E, or the arms may be attached to the package base or as solid fins with a void 106a in the middle of the substantially flat top 101 (fig. 1H). As shown in fig. 1K, the arms may also be attached to the bottom of a lens support having 6 arms with
curved side sections103 and a flat
top section101 formed by the upward facing ends of the arms. As shown in fig. 1K, the distal ends of the
peripheral supports105 may also be connected to individual supports from the base or directly to the base (fig. 1L).
As shown in fig. 1H and 1M, the fins, the base, or both may also be hollow to minimize the amount of packaging material used. Hollow or solid fins also replace the packaging solution, thereby reducing the amount required. The arms may be radially distributed around the centre of the support structure.
The flat top section may also include an
optional center fillet106a centered on the flat top portion, as shown in fig. 1A, 1O, and 1N. The center fillet may be included in a lens support with or without a center post, such as shown in fig. 1N and 1A, respectively. When a central fillet is included, its longest dimension may be from about 0.1mm to about 3mm in width; from about 0.1mm to about 2mm or less than 1.5mm. The central fillet may have any shape, including circular, triangular, or square with smooth or scalloped edges. The triangular or square shaped points may be located on the arms, offset from the arms, and may be rounded or pointed.
When open, the contact lens periphery will rest on the
peripheral support105, and the lens may otherwise rest on the central support or a portion of the central support (such as the shoulder transition 102). The
side section103 may have any shape that provides minimal contact and preferably no contact with the contact lens when the package is opened and drained so that the desired contact area difference is achieved when the lens is transferred. The side sections may be straight (unbent) as shown in fig. 1B-1F. As shown in fig. 1J, the lens may also be without side supports, with the flat
top section101 supported by the
central column108. As the solution drains, the lens may collapse toward the central support. The configuration of the peripheral support of the present invention, including the central support (if present) and the profile of the lens support do not substantially match the lens profile and prevent the lens from deforming or interacting with the lens support during drainage so that the lens resumes its shape and does not adhere to the central support during lens transfer. Preferably, the lens support profile that does not substantially match the lens profile comprises a central support profile that provides a gap between the lens and the side supports (if present), the gap being provided at least by straight angled side sections having an outward angle from vertical of no more than about 10 °, including central supports that do not have a side section or have a concave curve in the side section. It will be appreciated that lenses having higher modulus, such as silicone hydrogels, may deform less and may require a center support with less mismatch.
The height of the flat top section (when included) is measured from the point of contact between the lens and the peripheral support to the top of the shoulder, and may vary depending on the sagittal depth and curvature of the contact lens. For effective transfer, it may be desirable to deflect at least about 0.5mm, from about 0.5mm to about 2mm, from 0.5mm to about 1.5mm, or from about 0.8mm to about 1mm from the apex of the undeformed contact lens. For contact lenses having a sagittal depth of 3.8mm, a flat top portion having a height of about 2mm to about 3.3mm, about 2.5mm to 3.3mm, or about 3mm to about 3.5mm may be used. A column height of less than about 2mm can trap the packaging solution in the support base and encourage the lens to deform and bend in the center. These heights, whether measured from the apex of the lens to the top of the flat top (if present) or from the base, will provide the desired contact area between the finger and the lens to provide a consistent lens transfer without flipping the lens.
Removing the central column and leaving a void in the center can also provide a desired lens transfer, particularly for lenses having a neutral shape after drainage. The diameter of the void may be between about 5mm and the diameter of the lens (which provides support with only peripheral support as shown in fig. 1F and 1M). The void may be transparent or under the base of the lens. The voids desirably extend through at least 5mm to provide adequate drainage.
Any structure below the void preferably has a low surface area so as not to interfere with packaging solution drainage. For example, for a void extending to the base of the lens, at least about 50% of the base void area will be transparent. Voids extending below the lens base may have structures with a greater surface area, so long as the structures do not protrude above the base.
The length of the arms may also vary depending on where and where the arms are attached in the flat top region and whether the arms have perimeter supports. The arm attached to the center support (such as shown in fig. 1A) may have a length from the shoulder to the center point of about 1.5mm to about 4.5mm, about 2.5mm to about 4.5mm, or about 3mm to about 4.5mm. The length of the arm side section (when present) is determined by the height of the lens support and may be about 1.5mm to about 4.5mm, about 1.5mm to about 3.5mm, or about 2mm to about 3.5mm.
The side sections may be perpendicular relative to the base, or may have any
angle103a (fig. 1A) or curve that is less than the curvature of the lens so that the desired contact area is not exceeded. Suitable angles include about 15 ° outward from vertical or between about 1 ° and about 10 °.
The
angle103b at the elbow transition between the side section and the peripheral support (when connected to the arm) may be between about 60 ° and about 120 ° or between about 80 ° and about 100 °.
The number and shape of the arms can also be varied so long as they provide the desired balance of effective drainage of the packaging solution upon opening and contact area with the lens. The packages of the present invention may have one or more, three to eight, or three to six arms forming a central support that may be designed to provide a desired contact area between the lens and the fingers and resistance to touching against the fingers along a flat top, but only momentary contact with the contact lens at optional side sections and shoulder transitions. The shoulder transition may be disposed radially about a center of the support. The shoulder transitions may be spaced at substantially equal angles from the center. The arms may be planar, as shown in FIG. 1A, or curved, such as in a U-shape (not shown), or may be branched, such as in a straight or curved "Y" shape 101B, as shown in FIG. 1B, in a U-shape or T-shape. The branching of the arms may occur in the flat top region as shown in FIG. 1B, or at the peripheral support 105C as shown in FIG. 1C. The support may have all planar arms, all branched arms, or a mixture of planar and branched arms, for example two branched arms and two straight arms as shown in fig. 1C, three branched arms as shown in fig. 1b, or all planar arms as shown in fig. 1A. Examples of suitable arm configurations include three to eight or three to six planar arms, 3 straight or curved Y-shaped arms, 2 to 4 planar arms and 2 branch arms (which may be straight or curved Y-shaped, U-shaped, or T-shaped), and two planar arms and 2 branch arms (which may be straight or curved Y-shaped, U-shaped, or T-shaped). The arm configuration may provide shoulder and peripheral bolster contact points disposed along the plane of the arm (fig. 1A), or shoulder and peripheral bolster contact points that are offset from one another (fig. 1C).
The cross section of each arm is sufficient to provide the lens support with a resistance to prevent lens collapse during drainage, or excessive contact between the lens and the lens support during lens transfer. The lens support is preferably formed of a rigid material, and the resistance of the arm can be controlled by the modulus of the lens support material selected and the size of the arm. Rigid plastics suitable for injection molding small parts are suitable materials, such as polypropylene homo-and Copolymers (COP), cyclic Olefin Copolymers (COC) and mixtures thereof. Depending on the additive package included, polypropylene homopolymers and copolymers typically have flexural moduli in the range of 1100MPa to 1800MPa, COPs and COCs have flexural moduli in the range of 1800MPa to 2900MPa, and blends of polypropylene and COP or COC may have flexural moduli in the range of 1100MPa to 2900 MPa. The polypropylene may be nucleated, controlled rheology, or both, and both ziegler-natta and metallocene catalyzed polypropylenes may be used. The polypropylene polymer may also include additives including processing aids such as glyceryl monostearate, zinc stearate and calcium stearate, fillers which may modify the polypropylene properties, and the like.
References throughout this description to conventional injection molding processes and the use of materials conventionally applied to injection molding are to be understood as exemplary. Those skilled in the art will appreciate that other ways of manufacturing are possible within the scope of the appended claims, including but not limited to alternative molding processes, thermoforming, 3D printing, etc.
The width of the arms can vary between the limits of the molding process chosen and the width required for effective drainage of the packaging solution upon opening.
Suitable arm widths include about 0.5mm to about 1.5mm, about 0.5mm to about 1mm, or about 0.5mm to about 0.7mm, and it is understood that lens support designs with fewer contact points may have thicker arms.
The height of the arm may vary from the limits of the injection molding process to the height of the arm from the base, in which case the arm is a fin, as shown in fig. 1E and 1H, that may be attached to, molded as part of, or may rest on the base. When the arm is not a fin, it may have a height of 0.5mm to about 1.5mm, about 0.5mm to about 1mm, or about 0.5mm to about 0.7 mm. It should be understood that materials with lower modulus may benefit from arms with larger profiles in height, width, or both.
Suitable materials for the lens support must also be sterilizable, non-leaching, suitable for use with biomedical devices, and inexpensive. Preferably, these materials are also recyclable. The lens support material may, but need not be, optically transparent. The lens support material may be non-polar to facilitate drainage of the packaging solution. The non-polar material is a material having a contact angle of more than 90 ° at 25 ℃ via sessile drop method using deionized water.
It can be seen that the lens support of the present invention can have a variety of arm and peripheral support configurations and features, and is not limited by the particular combination shown in the drawings and discussed herein.
Additional combinations of arm configurations will be apparent to those skilled in the art in view of the teachings of the present application. The only limitation on the design of the arm is the ability to mold the lens support, and the number and orientation of contact points that balance the lens support with the desired drainage when open.
Drainage of packaging solution
The packages of the present invention may have additional features that, together with the lens support, allow the packaging solution to drain from the lens and lens support. Further, the drainage feature provides a drainage path for the packaging solution. When open, the drainage path produces an angled fluid film formed between two solid members (such as adjacent peripheral supports), a substantially vertical fluid film formed between two solid members (such as the central column and the side section), or a steep or substantially vertical path along a smooth solid surface (such as the side section). The shallower the angle of the drainage path, the more likely it is to disrupt the flow path and promote the formation of packaging solution trapped between the lens and the lens support (including the reservoir and residual film). An angled drainage path having an angle between 10 ° and about 90 ° is suitable. Lens supports and drainage features with sharp edges and very long paths can also interrupt the drainage path.
As described above, an integrally angled or raised lens support can provide the desired drainage. The lens support may also be horizontally disposed on the lens base and include a lifting structure, as described below. When present, the drainage channel cooperates with the lifting structure to create a temporary film of packaging solution that flows out of the lens, as well as a path for the film to drain under the force of gravity. In this manner, the drainage channel helps minimize pooling of the packaging solution between the back surface of the lens and the lens support structure when the package is opened and the lens support is lifted or tilted out of the packaging solution. The drainage channel includes at least one channel member extending outwardly from an arc of the circumferential ring, at least a portion of the circumferential ring, or an arc formed by the distal end of the non-elongate circumferential support. The drainage channel comprises a gap between two adjacent members, or a slit in a single member when a single member is used. For lens supports without a full peripheral ring, the drainage channel gap can begin at any point inside the lens periphery. For supports having a full peripheral ring such as shown in fig. 1C, 1I, and 1M-1O, the drainage channel gap may begin from the inner edge of the peripheral ring, as shown in fig. 1C, or from any point inside the lens periphery. If a peripheral ring is not included, the drainage channels can extend a length of at least 2mm, from about 2mm to about 4mm, or from about 2.5mm to about 3.5mm beyond the peripheral ring or lens periphery. The drainage channel gap can provide space for airflow outside the periphery of the contact lens, thereby ensuring that air and packaging solution from the concave surface of the lens can be expelled when opened without drawing the lens down onto the lens support. Thus, in fig. 1E, the portion of the
gap111 that is inside the lens periphery does not substantially participate in drainage.
The upper limit of the drainage channel length is defined by the final dimensions of the package and the lifting structure (if included).
Referring to fig. 1B, the
drain channel member115 can be formed by extending adjacent
peripheral support portions105 over at least a portion of the arc of the
peripheral ring109 and connecting the distal ends via a
crossbar114 to form a gap or
open channel111 between the
drain channel members115. As shown in fig. 1C,
channel member115 may be attached to and coplanar with at least a portion of
peripheral ring109. As shown in fig. 1D,
drainage channels113 can also be formed by extending the
ring support structure105 from a
point112 inside the lens edge to a point beyond the arc of the at least partial peripheral ring, and joined at the distal ends by a
crossbar114. The drainage channel may also be formed by attaching the
channel member115 to the arms at any point, including to the bottom of the fins when the arms are fins (as shown in fig. 1F). As shown in fig. 1C, the drainage channels can also be formed by providing gaps in the peripheral ring from which planar arms extend, such that the peripheral ring and
drainage slots113 form a keyhole shape. When present, the perimeter ring/partial perimeter ring may be connected to the elongated arm.
The
drainage channel member115 can be straight, as shown in fig. 1C-1G, can be curved, as shown in fig. 1B, can open at a peripheral loop arc and taper from the arc to the distal end, or can taper from at least a portion of the peripheral loop to the distal end of the drainage channel. Any taper may be straight or curved. As the discharge channel tapers, the channel tapers toward the
crossbar114. The drainage channel can be about 0.8mm to about 3mm wide, and when tapered can be about 1mm or about 0.8mm wide at the distal end or crossbar.
Other drainage channel configurations not shown or configurations incorporating aspects of the exemplary configurations depicted are possible within the scope of the appended claims and will be apparent to those skilled in the art in view of the balance of this disclosure. Furthermore, in some embodiments, the drainage channel may be omitted entirely. For example, when the lens support is fixedly angled relative to the bottom of the base, such as in fig. 1H, a drainage channel is not necessary, and the angle of the lens support provides the desired drainage when the package is opened.
Lens presentation
The package of the present invention may further comprise a lifting structure for
The lens support is lifted from the lens solution. The lifting structure may present the lens support and lens from the base and packaging solution in any suitable manner, including tilting the lens support upward, tilting the base downward, lifting the lens support upward from the base, lowering the base downward, or any combination thereof, and the like.
The drainage channel in cooperation with other features of the package may be used as a lifting device, or the lifting device may comprise additional structures such as springs, hinges, levers, pivoting arms, folds, mechanical traps, handles, and combinations thereof. The lifting member can include a rigid elongate member extending outwardly from a structure disposed along the bottom of the lens support, which can form a portion of the drainage channel. For example, a lens support with an
elongated drainage channel115 can include a hinge line in a package base, such as shown in fig. 2. Such hinge lines may be formed from a flexible sheet as the bottommost layer of the packaging base, with molded plastic posterior and anterior sections that may abut one another or be detachably attached to one another along the line of the
fold216, which allows the anterior 217 and
posterior218 of the base to pivot along the
fold216, lifting the lens support and
lens200 from the packaging solution. When included, the folds are preferably located outside the arc of the peripheral ring and transverse to the drainage channels and drainage gaps, as shown in fig. 2. When included, the fold will define the distal end of the drainage channel and, if not included, should be positioned at least 1mm, about 2mm to about 4mm, or about 2.5mm to about 3.5mm long beyond at least a portion of the peripheral ring or lens periphery. The position of the folds along the channel member can be selected to provide a desired lift separation from the package and draining of the packaging solution away from the lens support and lens such that upon separation of the lid from the base to open the package, the distal end of the lifting structure pivots downward along the pivot axis, lifting the lens support from the packaging solution and draining the solution from the lens. Upon opening, the lifting structure pivots about the fold line at an angle of about 15 ° to about 80 °, about 20 ° to about 70 °, about 30 ° to about 60 °, or about 40 ° to about 60 ° relative to horizontal.
For lens supports having shorter channel members (such as the keyhole configuration shown in fig. 1C), the folds may be adjacent to the peripheral ring arc if the peripheral ring is greater than the contact lens diameter by more than 4mm. For lens supports having longer channel members, the fold can be located between about 0.2mm from the distal end of the drainage channel, about 1mm from the distal end, about 2mm to about the distal end of the length of the channel member that drains from the peripheral arc.
The drainage channel member is preferably rigid on the fold line and can be fixedly attached to the front section of the base sheet. Any means for attaching the distal portion of the channel member to the base may be used, including adhesives, glues, any suitable welding (including but not limited to heat, ultrasonic or laser welding), or mechanical traps.
When the drainage channel also functions as a lifting mechanism, it can have any configuration suitable as a drainage channel, including at least two elongated peripheral supports extending beyond the arc of at least a portion of the peripheral ring, a channel member extending from the peripheral ring, or a separate channel member extending from the bottom of the lens support, any of which can be connected at their distal ends.
The lifting mechanism may also be a
flexible attachment member245 located between the
lens support236 and the
cover235 and located opposite the cover-
removal tab228, such as shown in fig. 2B. The flexible attachment may have any suitable structure, including a hinge, a flexible fold, a pivoting arm, a mechanical trap, and the like. The action of pulling up on
tab228 and
lid235 opens the package and also lifts
lens support236 from
base240, thereby presenting
lens200 for removal by the user.
A simple ring, tab or handle may be substituted for
hinge245 as the lifting mechanism. The user can open the lid and lift the lens support from the solution by lifting the tab or handle.
Other hinge and lever configurations are known in the art, such as those disclosed in US20140027462, DE4415003 and JP 6339322. Alternatively, the lens support side section may be deformable, replaced with a spring structure, or a spring structure may be included below the peripheral support or peripheral ring, such that in the closed position, the cover engages the lens support to compress the support without compressing the lens. When the package is opened, the spring relaxes and the lens support lifts the lens above the packaging solution. In this configuration, the peripheral support and central support top section (if present) are preferably made of a rigid material to limit contact between the lens and the lens support and to provide resistance during lens transfer. Any deformable structure incorporated below the peripheral support should be designed not to detract from any drainage features (including the peripheral support and the ring) included in the lens.
It will be appreciated that a separate drainage channel may not be required for the lifting mechanism that lifts the lens parallel to the base.
The rear, front, or both may further include a
reservoir219 for capturing packaging solution as the lens is lifted from the base. The bottom of the package may include a retortable film, including multilayer films for packaging contact lenses, which films may be formed of molded plastic or may have a retortable film bottom attached to a base wall of the molded plastic. Any combination of materials may be used for the base so long as they meet the performance requirements.
Cover
The package of the present invention further comprises a lid. In conventional contact lens packages, the contact lens is located in a molded plastic base with a bowl to receive the contact lens in a concave, bowl-up position. The laminated foil is heat sealed to the molded plastic base. In the package of the invention, the laminated foil forms the outer layer of the base of the package and optionally the lid. A lens support and optionally a package side wall are attached to the base, and a molded plastic lid or flexible foil and a molded plastic frame between the cover sheet and the lens are releasably attached to the package base via a retortable seal, thereby forming a cavity containing the lens solution, the lens and the lens support. When the cover comprises a flexible sheet and a molded plastic frame, they may be separate or joined together by any suitable means, including adhesives, glues, thermal bonding, welding (such as heat, ultrasonic or laser welding), or mechanical traps, among others.
In addition to sealing the package, the lid may also be designed to control the flow of air into the package when opened. It is desirable that the contact lens remains on the lens support when opened, rather than adhering to the cover. To accomplish this, air entering the package upon opening can be directed to first travel over the top of the lens.
Two features have been found to be beneficial in directing air over the lens when open: an air intake guide along the inner lid surface and an air intake at a designed opening point (such as inside the retortable seal). The packages of the present invention may include one, both, or neither of these features.
The air intake guide provides space for air to travel over the lenses without being trapped or diverted, and may also cooperate with the lens support to prevent the lenses from lifting or sliding off the support structure until some air has entered the package over the lenses. The contact area between the air intake guide and the lens is preferably low, less than about 50mm 2 Or less than about 30mm 2 。
The air intake guide may be molded into the cover, either on the inner surface of the cover or as a protrusion from the cover, or may be a separate structure disposed between the lens and the cover when the package is sealed. Upon opening the package, the air intake guide directs air into the package along a designed path over the top of the lens, thereby ensuring that the lens is retained on the lens support in the desired convex orientation. The air intake guide is disposed in a direction in which the packing lid moves when the package is opened. The air intake guide may have any orientation other than perpendicular to the path of the desired air flow. When the package is designed to be opened from the front, the air intake guide is preferably disposed from the front to the back of the package, and the intentionally designed path is from the front to the back of the package on the lens.
As shown in fig. 3A and 3B, a suitable air intake guide may include a
pin321 protruding from the cover around the periphery of the lens. The prongs may be rigidly mounted to a support ring or molded plastic ring (fig. 3A), or may be flexibly mounted to a flexible sheet (fig. 3B), such as a lidstock. The pins may be radially disposed about the periphery of the contact lens, typically within 1mm of the lens edge. The intake guide may comprise pins positioned around the entire perimeter or primarily along the front, side, or front and side surfaces. The pins may be adjacent to each other as shown in fig. 3B or may be spaced apart as shown in fig. 3A. When radial pins are used, the optical zone of the lens may be free of pins to facilitate air traveling over the top of the lens while the pins keep the edge of the lens from adhering to the cover.
The air intake guide may also be in the form of continuous or discontinuous (broken) ribs. The ribs may be attached to the inner surface of the molded cover (fig. 3C) or included via a separate molded structure (fig. 3D). The ribs are aligned parallel to the path of air entry when the package is opened. The ribs may be spaced apart by at least about 2mm, about 2mm to about 5mm, or 2mm to about 4.5mm. The ribs may extend in a straight line from the anterior to the posterior (fig. 3C and 3D) or may be curved around the optical zone (fig. 3E) to prevent interaction between the ribs and the contact lens, which may cause optical deformation in the high shape memory hydrogel. The ribs may extend "edge to edge" across the inner cap surface as shown in fig. 3G, or their starting or ending points may be offset from the edges.
The ribs can also extend away from the lens, forming
depressions337 protruding upward from the cover surface, as shown in fig. 3H. As described below, such depressions may serve as air intake guides as well as air capture spaces during opening.
The ribs may have straight walls, may be wedge-shaped, may include an arc, or may have one straight wall and one angled or arc-shaped wall. The angled or curved wall may be inclined along the curvature of the contact lens.
The rib height may be the same from the front to the back of the rib (outer rib in fig. 3B), or the front may be greater than the back (fig. 3C and 3G). The ribs may have a shorter profile across the optical zone, as shown by the central rib in fig. 3C, or there may be gaps in the ribs ("broken ribs" 322 b), as shown in fig. 3F. An intake guide including a central rib having a progressively decreasing rib height across the optical zone effectively directs air in a desired direction while also minimizing contact with the optical zone of the contact lens. As shown in the figures, different height profiles and shapes may be incorporated into a single air intake guide structure.
The ribs may have a height of at least about 2mm, which may extend from the interior of the cover toward the contact lens or may extend away from the contact lens and define separate air intake channels. The rib height may be at least about 2mm at the highest point, such as the height at 522 (the air intake guide outside of the optical zone), and 0mm to about 0.5mm at the lowest point, such as the height at the rear of the rib in fig. 3C and 3G, or at the middle section of the central rib in fig. 3D, 3E and 3F. Below the peak rib height of 2mm, air bubbles in at least some of the ribs may not spread over the entire top of the lens, and the lens may stick to the bowl. Rib heights above about 4mm may undesirably increase the size of the package and the volume of packaging material and packaging solution required.
When a straight rib having a shorter profile is used in the
central rib322a (fig. 3D), the maximum length of the tapered profile along the rib is about 8.5mm. When curved ribs having a shorter profile are used in the
central rib322a (fig. 3D), the maximum length of the tapering profile along the rib is about 9mm.
In addition to minimizing the height profile of the portion of any
rib322a that traverses the optical zone of the contact lens,
adjacent ribs322b can be curved outside of the optical zone. When included, the curved rib region may have a diameter of up to 11mm or between about 7mm to about 11mm or between about 8mm to about 11 mm.
When the rib is part of a separate molded plastic frame, it may include cross supports on the back side of the rib. However, the height of the ribs should ideally maintain a gap of at least about 2mm between the lens and the cross-support to provide the desired airflow. Preferably, when cross supports are used, they are located on the rear of the ribs and do not project or extend into the path defined by the air intake guide. Preferably, the air intake guide structure is free of transverse structures, such as cross supports, or has less than 3 or 1 cross supports or no cross supports.
As shown in fig. 3D-3F, when the intake guide is a separate structure from the cover, the intake guide may further include a full or partial ring around the intake guide, as shown as 327a in fig. 3E and 327B in fig. 3B, respectively. When used, such an intake guide may be attached to the lens support by a hinge (not shown) opposite the front of the intake guide to form a clamshell structure around the lens, which may then be sealed in a single folded laminate or between two separate laminates, which may be the same or different.
In addition to forming a sealed cavity to contain the lens and packaging solution, the cap of the present invention can also cooperate with the lens support to keep the lens centered around the support with minimal contact between the optical zone of the lens and the support and the cap. For lenses with high shape memory, the ribs can be designed such that any contact between the lens and the cover or lens support is temporary when the package is sealed.
A second feature that may contribute to air flow control is an
air inlet324, shown in fig. 3G and 3H, and shown as 224 in fig. 2B. When included, the air inlet is located at the designed opening point inside the retortable seal, i.e. the front of the package in fig. 3G. The aperture may be directly aligned with the opening tab, as shown in fig. 3G and 3H, or may be offset, but aligned with the
opening tab228, as shown in fig. 2B. In this embodiment, the
port324 protrudes at least about 1mm or at least about 2mm from the periphery of the contact lens edge and is located within the seal. The length of the tab is limited only by the desired size of the package. The inlet has a width between about 2mm and the inner diameter of the sealing
arc325. The gas inlet may be shallower than the lid and may be sloped into the lid cavity as shown in fig. 3G. In addition to the dimensions described above, the orifice may have any shape, including but not limited to circular, oval, triangular, square rectangular, or irregular. The packages of the present invention can forego a separate air inlet, such as by providing a gap of at least about 2mm between the inner lid wall and the lens support at the opening tab.
Fig. 3G is an inside view of the package lid and skirt region. The lid will seal the membrane base along
seal line326. The
air scoop324 is located at the front of the cover and includes the anterior section of three broken air
scoop guide ribs322a (which traverse the middle of the optical zone but have a shallow height within the optical zone) and 322b (which curve around the optical zone of the lens). The package is opened by pulling on a
tab328 which separates the lid from the base, starting from the distal end of the air intake tab. The tabs may be of any form, including foil or plastic tabs, grips, tabs, handles, and the like.
Bubble management
For some lenses, it may be desirable to minimize contact between the lens and any air bubbles in the package when sealed. Although it is possible to design the package without any air bubbles when sealing the package (e.g. by using a double-sided foil bag as the outer base and cover), air may still diffuse into the package during the shelf life of the lens. Thus, it may be desirable to include features within the package to trap air bubbles away from the lenses in preferably all storage orientations. As noted above, this may be more desirable for lenses with longer shape memory.
The cap of the present invention can further include at least one air capture space remote from the optical zone of the lens for occupation by air in the sealed package. The air capture spaces are designed such that air is retained in at least one air capture space away from the lens regardless of the orientation of the package. The volume of the air capture space can be equal to or slightly greater than the volume of the air to be sealed in the package and any air that may diffuse into the package during storage to ensure that all air present at the time of sealing and any air that may diffuse into during storage remains away from the optical zone of the lens.
The air capturing space can be designed in various ways. For example, as shown in fig. 3G, the cover can further include a recess or
pocket329 over the center of the lens support to force any trapped air up and away from the lens vertex (not shown) around the
perimeter330 of the
pocket329. The depth of the well is selected so that the lowest point of the well in the lid interior or any air intake guide does not contact the apex of the lens when the package is sealed. The gap between the optical zone and any air intake guide or pocket is between about 0.25mm and about 2mm. Fig. 4A is an external view of a package comprising a lid of the present invention. The
pit430 is surrounded by an
air capture channel431. The depression formed by the dimple diverts any entrained air into the air capture channel. The pits can have a diameter of at least about the diameter of the optical zone of the lens. The combination of the dimples and air capture channels maintain the entrained air in a position ranging from upright (base down) to 90 deg.. When the package is inverted, the air bubbles are above the lens edge, and this is not a problem.
The
channel431 may have the form of a ring as shown in fig. 4A, or may have any other connecting shape that provides a section higher than the center of the cap. For example, the air capture space may be in the form of a continuous channel around the inner sealing edge, with sections located above and below the apex of the lid, such as shown in fig. 4B, with 3 raised channel portions 431a. The size of the air capture channel can be determined based on the volume of air to be included in the package and the amount of air that will diffuse into during storage, which can be easily calculated. The channels may have any cross-sectional shape, including circular edges, semi-circular or semi-elliptical, rectangular or square. In some embodiments, the channel may have an internal width of about 1.5mm to about 3mm or about 2mm to about 3 mm.
Instead of, or incorporated into, the channel, the air capture space may comprise at least two air pods projecting from the cover along the inner sealing edge. The raised channel portion 431a in fig. 4B is an example of 3 air tank boxes connected in a continuous channel.
Air compartment331a may be linear or arcuate (as shown in fig. 3H), parallel or transverse to the direction of air intake, and may be separated by dimples or connected by connecting
channels337. The air capture space may include at least one, two, three or more air pods with or without connecting channels. The air tank box may be wider, taller, or both wider and taller than the connecting channel.
The air compartment box and the connecting channel can have any cross-sectional shape that can be molded, including circular edges, semi-circular or semi-elliptical, rectangular or square. The connecting channel may have an internal width of about 1.5mm to about 3mm when it is desired for the bubbles to pass between the pods, or about 0.5mm to about 2mm in designs intended to prevent bubbles from exiting the pods.
The air capture channels and air pods may be included in the cover with or without the pockets.
The lens support and the cover can be designed to cooperate when in the sealed orientation to keep the lens centered about the support structure without resting on the support structure or the cover. This is even more important for lenses with longer shape memory, such as silicone hydrogel lenses, and the optics of the lens may deform from prolonged contact with any packaging features or any air bubbles trapped in the package. Conventional hydrogel contact lenses can receive contact between the support, the cover, and the contact lens during storage and transportation because they have a relatively short shape memory.
The lens support can be designed in a variety of configurations to provide the desired drainage and support, as long as the primary function of providing sufficient drainage and contact with the lens is satisfied to ensure consistent "one-touch" lens transfer to the finger. It will be apparent to those skilled in the packaging art that the packaging features described herein can be used in a variety of combinations to achieve a desired one-touch package. For example, if the packaging solution is trapped between the lens and the support, the efficiency of the drainage path may be increased, for example, by increasing the open area under the lens support, decreasing the contact area between the lens and the support, decreasing the sharp edge and shallow drainage path, increasing the drainage channel, with or without a tilt or lift device, or a combination thereof. If the lens adheres to the cover when opened, an air intake guide and/or air intake may be added.
The benefits of the package of the present invention are apparent in use. Fig. 5A and 5B include examples of packages of the present invention having different combinations of features. These drawings and description are exemplary only, and should not be considered limiting of the inventive package design.
Fig. 5A shows a view of an opened
package500. Comprising from top to bottom in package 500: a molded
plastic lid535 with a no-
leak seal526 on the outer perimeter of the lid cavity. Below the
lid535 is an
air inlet524. The air inlet in fig. 5A is an integral structure within the lid, but may be a structure separate from the lid. The
intake guide522 is in the form of a broken rib and directs the flow of air over the
lens550 so that the lens will not adhere to the
lid535 when the
package500 is opened.
In the sealed state, the
lens550 is held in the space (lens cavity) formed between the
package cover535 and the
lens support536. The lens cavity can be designed so that the lens 535 (particularly in the optical zone) is not compressed during shipping and only minimally contacts the internal features of the package and maintains integrity until the package is opened. Moreover, the lens cavity should not provide too much clearance between the lens and the internal package features so that the lens remains in the desired convex orientation relative to the package base during shipping and storage.
550 rests below
cover535 and above
lens support536. The lens support can have a variety of configurations as described above. Generally, the lens supports 536 maintain the lenses in a desired convex position with a minimum contact area when the
package500 is opened to ensure effective transfer of the lenses to the user's fingers. The
lens support536 is placed on a base 540 having a
front base section516, a
base fold line517, and a base rear section with a
reservoir519. The lens support is attached to the
front base section516 such that the lens support and lens when opened can pivot upward from the base
rear section518 along
fold line517. The base and lid form an
interior chamber544 when the package is closed and sealed. The
inner chamber544 is designed to hold the correct volume of saline solution to allow the lens,
lens support536, and cap 535 to work properly together. Finally, the
base540 also contains an
external reservoir519 that captures the discharge of any entrained solution from the
inner chamber544 upon opening of the package.
The package is opened by pulling the
tab528 upward, which breaks the
seal526. Air is introduced into the package in a controlled manner and is introduced into the package by the
intake guide522 so that the lens is deflected away from the
package cover535 and retained on the
lens support536. This gentle force works in conjunction with the expulsion of solution from the
lens550 and the
lens support536 such that the lens is generally held in a "ready to use" position on the
lens support536. When the
lid535 is lifted, the front of the
base540 is lowered, pivoting the
lens support536 about the
fold line517 to expel the packaged solution from the
lens550 and the
lens support536 and present the lens for transfer to the wearer's fingers. The central optical zone of the
lens550 is typically not in contact with the arms, except at the
peripheral support505. The flat
top area501 provides resistance to enhance the ability to transfer the
lens550 to a finger with a "one touch".
The
lid535 and the
reservoir519 may be polypropylene or any other material useful in medical device packaging, and the
base540 is formed of a foil or laminated film structure that is sealed to the
lid535, typically via thermal welding or any other method capable of forming a retortable seal.
Fig. 5B shows an enlarged view of another package of the present invention. The intake guide has a full
circumferential ring527 and is a structure separated from the
cover535. The intake
guide perimeter ring527 is connected to the
lens support536 via a
flexible linkage545, such as a hinge or a flap. The intake guide and lens support closely surround the
lens550 like a clamshell and protect the
lens550 from damage and hold it in the desired position. The
base540 and the
lid535 may be made of any sheet or laminated film, and may be a single sheet folded opposite the
pull tab528, or may be two separate sheets that may be made of the same or different materials.
As shown in fig. 5A and 5B, features of the package, including the lens support, cover and air intake guide (however created) can be designed to interact with the lens outside of the optical zone to prevent damage to the lens optical zone.
When the package is opened, such as by lifting the
lid535 from the
base540, the
air intake tabs524 and guides 522 direct air over the
lenses550, gently biasing the lenses away from the interior of the lid and ensuring that the lenses remain on the lens supports 536. Any packaging solution contained in the
package500 is drained from the
lenses550 and the lens supports 536 such that only a minimal amount of packaging solution remains on the back sides of the
lenses550 and the lens supports 536.
This gentle force works in conjunction with the expulsion of the solution and the arms of the lens support so that the lens is normally in a "ready to use" position on the lens support.
Because the contact area between the
lens550 and the
lens support536 is minimized and the packaging solution is effectively withdrawn, the wearer can remove the
lens550 from the package with one touch of a finger and adhere the convex side of the
lens550 to the finger. Thus, the apex of the
lens550 is positioned on the finger and can be applied directly to the eye, with its concave portion placed directly on the eyeball. The wearer does not need to transfer the lens from the fingers of one hand to the fingers of the other hand, as is common with contact lens packages of current design. This improved series of steps is not only easier and more convenient for the user, but also reduces contamination due to bacteria carried by the user's fingers.
Accordingly, the present invention provides a package: these packages effectively direct the packaging solution away from the lens and lens support and control the ratio of the contact area between the fingers and the lens to the area between the lens and the lens support, thereby ensuring that the surface tension between the fingers and the lens exceeds the surface tension between the lens and the lens support. The lenses so presented adhere consistently to the fingers, providing the wearer with a "one touch" lens transfer experience.
The packages of the present invention can be made using known materials and processes. The packaging material may be solar heated, recyclable or a combination thereof. The volume within the package cavity may vary depending on the design selected.
As noted above, not all of the features described herein need be incorporated into each package, and those skilled in the art, using the teachings herein, combine these features to provide a variety of one-touch packages. For example, a lens support with a central lens support may be desirable for lenses with a modulus of less than about 25psi, new wearers not accustomed to one touch lens removal, or wearers with a more powerful tactile sensation. Experienced wearers and less experienced wearers may require a package with only a perimeter support. It should also be understood that the packages of the present invention provide many opportunities to include ornamental designs and features, such as in the design of peripheral supports and rings, arms, fins, air-piping, and channels, as well as overall package shape and contour.
In summary, the contact lens packages of the present invention include several novel functions that can be combined in various combinations as described herein to provide a desired one-touch package, including the following functions.
Preventing the lens from rotating away from the support, which can be achieved by:
a minimum of 3 contact points are included on the periphery of the lens, which may be arranged in an acute triangle.
Prevention of horizontal translation of the lens through the support may be achieved by horizontal or near horizontal contact near the lens periphery, where the angle of the lens surface is steeper (outside a central region having a diameter of at least about 5mm, about 6mm, or about 7 mm), or the contact may be just outside the lens periphery.
After drainage, the lens is held in its neutral or near neutral shape for demonstration of lens transfer.
This can be accomplished by minimizing contact between the lens vertex and the support, by providing a central lens support having a gap of about 0.5mm to about 2mm, about 0.5mm to about 1.5mm, or about 0.8mm to about 1mm between the top of the flat top portion and the lens vertex, or by leaving a gap of at least about 6mm in diameter and level from the lens vertex to about the lens base.
Resistance to fingers when patted
This is advantageous for increasing the finger surface area and controlling the tap force and contact time during tapping.
For lenses with low modulus, this requires a reinforcing structure below the lens apex, which can also improve the transfer consistency of lenses with higher modulus (including silicone hydrogels). When present, the height of the structure is not lower than the base of the lens. The support structure may also be less than 2mm below the apex of the lens.
The shape of the surface may be flat or slightly concave (e.g., radius of curvature as low as about 10 mm), but less preferably slightly convex (radius of curvature as low as about 10 mm) or more concave (e.g., radius of curvature as low as about 6 mm).
The diameter of the surface should be about 1mm to 10mm, preferably 6mm to 9mm (to match the fingertip size).
The surface need not be continuous, it may consist of a series of dots or lines.
The optical zone is free floating and contact with the lens support during storage is brief or non-existent. This can be achieved by making any central support slightly lower than the lens profile (so that the lens only contacts the support at the periphery).
The following test methods were used in the examples.
Root mean square wavefront error ("RMS error" or "RMS") measures the deviation of the wavefront of the lens from the intended design wavefront. When the intended design is unknown (such as when measuring contact lenses of commercial origin), RMS can be measured by comparing the wavefront of a lens packaged and sterilized in a conventional "bowl-up" lens package to the same lens repackaged and sterilized in the package of the present invention.
Calibrated dual interferometry is used to measure Root Mean Square (RMS) optical path wavefront deviation of the lens design target ("RMS") in microns (μm), with the sphere/cylinder power and coma removed, as measured using a 6.5 mm aperture. The instrument consists of a custom interferometer and Lumetrics for measuring wavefront parameters
II low coherence interferometer. The combined two separate instruments are similar to Lumetrics Clearwave TM Plus, and the software is similar to the Lumetrics OptiGauge Control Center v7.0 or higher. Using Clearwave TM Plus, camera used to find the lens edge, and then calculate the lens center, which was then used to align the 1310 nm interferometer probe at the lens center for measuring sagittal height and center thickness. The transmitted wavefronts were collected in series using a wavefront sensor (shack-Hartmann sensor). A plurality of parameters of the transmitted wavefront from the contact lens are measured and other parameters are calculated from those measurements.
From the collected data, a difference term is calculated by comparing the measured value with the target. These data include the root mean square optical path wavefront deviation (sphere/cylinder power and coma deviation removed) of the lens design target in μm, as measured using a 6.5 mm aperture (RMS — 65).
The lenses were placed concave down in optical quality glass cuvettes without scratches, streak, water spots or coagulum and filled with packaging solution. Only lenses without visual defects (non-circular edges, debris and/or edge tears, folds in the package, inversion) were selected for measurement. The lens was left free floating with no air trapped under the lens. The lenses were placed in the cuvette free floating, taking care not to deform or damage the optical zone, and no air was trapped under the lenses. The cuvette with the lens was placed in an interferometer and the measurement was performed at 20 ℃.
Examples
The following test methods were used in the examples:
root mean square wavefront error ("RMS error" or "RMS") measures the deviation of the wavefront of the lens from the intended design wavefront. When the intended design is unknown (such as when measuring contact lenses of commercial origin), RMS can be measured by comparing the wavefront of a lens packaged and sterilized in a conventional "bowl-up" lens package to the same lens repackaged and sterilized in the package of the present invention.
Calibrated double interferometry is used to measure Root Mean Square (RMS) optical path wavefront deviation of a lens design target ("RMS") in microns (μm), with spherical/cylindrical power and coma removed, as measured using a 6.5 millimeter aperture. The instrument consists of a custom interferometer and Lumetrics for measuring wavefront parameters
II low coherence interferometer. The combined two separate instruments are similar to Lumetrics Clearwave TM Plus, and the software is similar to the Lumetrics OptiGauge Control Center v7.0 or higher. Using Clearwave TM Plus, the camera is used to find the lens edge, and then calculate the lens center, which is then used to align the 1310 nm interferometer probe at the lens center for measuring sagittal height and center thickness. The transmitted wavefronts were collected in series using a wavefront sensor (shack-Hartmann sensor). A plurality of parameters of the transmitted wavefront from the contact lens are measured and other parameters are calculated from those measurements.
From the collected data, a difference term is calculated by comparing the measured value with the target. These data include the root mean square optical path wavefront deviation from the lens design target (sphere/cylinder power and coma deviation removed) in μm, as measured using a 6.5 mm aperture (RMS — 65).
The lenses were placed concave down in optical quality glass cuvettes free of scratches, streaks, water spots or coagulum and filled with packaging solution. Only lenses without visual defects (non-circular edges, debris and/or edge tears, folds in the package, inversion) were selected for measurement. The lenses were placed in the cuvettes with free floating, taking care not to deform or damage the optical zone, and no air was trapped under the lenses. The cuvette with the lens was placed in an interferometer and the measurement was performed at 20 ℃.
Examples
The following materials were used in the following examples.
Buffer solution: 1000g deionized water, 13.55gm NaCl, 27gm boric acid, 5gm sodium borate, 0.3gm EDTA, and a pH of about 7.4.
Packaging the solution: revitalen Complete (alexidine 0.00016%; polyquaternium-10.0003% (PQ-1); EDTA.
Polypropylene: isotactic polypropylene homopolymer, MFR 24g/10min, from Total (Lumicone M3766)
Covering materials: a multilayer film comprising oriented polypropylene (12 μm), aluminium foil (50 μm) and polyester film (12 μm).
Examples 1 to 6 and comparative examples 1 to 2
Several lens support architectures were evaluated to determine the support features that could provide the desired lens support, packaging solution drainage, and lens transfer. Each of the evaluated lens supports was 3D printed on Form2 using a Formlabs clear resin. The lens support is printed with a drainage channel ending in a 90 ° lever to allow the support and lens to be lowered and raised from a packaging solution chamber with dimensions 30mm x 45mm x 25 mm.
Daily disposable ACUVUE MOIST contact lenses were removed from their packages and placed on each lens support while the support was submerged in the packaging solution to allow complete wetting and the lens was centered on the support. The lens support and lens are submerged in the packaging solution chamber for at least 5 seconds to ensure complete submersion without air bubbles remaining under the lens. The packaging solution was removed using a dropper to expose the perimeter support. The support is then pivoted out of the remaining packaging solution slowly using the lever and allowed to drain until the solution appears to have drained from the lens and support, or after about 10 seconds (whichever is earlier). The lens is evaluated for a permanent fluid film, a solution reservoir, and an internal bridge between the lens and the support. Photographs were taken and evaluated for lens centration, fluid area captured between the lens support arm and the lens, and lens deformation.
To ensure a consistent tap surface and to simulate low adhesion fingers, rubber nitrile gloves were worn on the hands used for the tap test. The test was repeated at least 5 times for each support design, with the lens being replaced after 2 repetitions.
The results are shown in table 1 together with representative photographs and CAD drawings showing the configuration of the lens support.
As the packaging solution is expelled from the contact lens, a film of packaging solution may form between the lens edge and the peripheral ring. The film formed at the beginning of drainage is good and for a lens support with good drainage, the film breaks before drainage is complete. Once drainage is stable, the remaining residual film interferes with lens transfer. The films reported in the table are the residual films remaining once drainage is stabilized.
The example of a lens deformed and wrapped around a support structure tends to hold more solution in the lens. This may be detrimental to tapping (comparative example 1) or slowing drainage (example 4). The arrangement of both the peripheral support and the central support is important in reducing and preventing wrapping. The lens wrap for 6 peripheral supports (example 3) is significantly reduced compared to 4 peripheral supports (example 4). Poorly distributed center supports (comparative example 1) had more wraps than well distributed center supports (example 3).
The peripheral ring may also reduce lens wrap due to surface tension of the film formed around the lens periphery. Example 1 shows less lens wrap than example 2 (no ring).
Example 5 is the same lens support as example 3, but with the addition of a peripheral ring around the peripheral support. Both example 5 and example 3 show excellent drainage speed (medium-fast and fast, respectively) and excellent drainage efficiency, as evidenced by the absence of a permanent fluid film, a small solution reservoir, and only a light internal fluid bridge.
Example 6 is the same lens support design as example 2, but the arms are solid fins connected to the peripheral supports. Filling in the arm structure slows drainage but drainage efficiency is the same as in example 2, confirming that the lens support of the present invention with open arms or solid fins can provide good drainage and consistent lens transfer. Comparison between example 2 and example 6 also shows that the drainage velocity can be reduced by removing structures (such as solid fins) underneath the lens support.
The lens support of comparative example 2 has a similar structure to example 1, but with curved side sections that form a severe internal fluidic bridge that causes the lens to adhere to the lens support, creating an undesirably high lens-to-support contact area. The increase in contact resulted in a 0% transfer rate at finger tap. Thus, a support structure that forms more solution bridges is less likely to be tapped successfully. The lens support of comparative example 3 has a fully curved lens support with a smaller radius than the lens support of comparative example 2, but still shows undesirable solution reservoirs and internal fluidic bridges. Comparative example 3 also had a fully curved top section that provided insufficient contact area between the lens and the finger at the time of the tap (0% success of the first tap).
Comparative example 3 to comparative example 4 and example 7 to example 8
The lens holder test was repeated as described in example 1 using the lens holders shown in table 2.
Example 9, example 10 and comparative example 6 show significant lens movement during opening, which can be improved by providing one or more positioning guides along the top of one or more of the peripheral supports. Examples 9 and 10 show that a lens support with only a peripheral support and no central column can provide good drainage and lens transfer. Example 10 has a gap of 8mm between opposing peripheral supports with one side of the drainage channel extending to the centre of the supports. The lens support of comparative example 6 is similar to the lens support of example 10, but without a peripheral support arm extending below the lens center. The lack of structure in the center of the lens results in the lens collapsing in the center during drainage or when lens transfer is attempted, and the resistance provided during lens transfer is also insufficient. The ACUVUE Moist lenses used have a very low modulus and lenses with higher modulus (such as silicone hydrogels) will not collapse easily. Extending at least one peripheral support arm below the center of the lens reduces lens collapse at the center and provides good lens transfer, as shown in examples 9 and 10. The flat dome can be designed to have enough surface area to suck the lens onto the dome to prevent the lens from moving (comparative example 10), but it also prevents tapping.
Example 11 to example 14
Example 7 was repeated, varying the diameter of the peripheral ring, as shown in table 5. A support with a 16mm peripheral ring traps the solution between the lens and the support. Both supports with 18mm and 25mm perimeter rings provide good drainage with little reservoir to trap the packaging solution. Although the use of a 16mm diameter in the support of example 14 is too small for a 14.2mm diameter lens, it is acceptable for a smaller diameter lens.
TABLE 5
Examples 15 to 16, comparative examples 8 to 10
Several lens support architectures were evaluated to determine the support features that could provide the desired lens support, packaging solution drainage, and lens transfer. Each of the evaluated lens supports was 3D printed on Form2 using a Formlabs white resin. The lens support is printed with "L" shaped handles on opposite sides of the lens support to allow the support and lens to be lowered and raised from a packaging solution chamber having dimensions of 30mm x 45mm x 25 mm.
Daily disposable ACUVUE MOIST contact lenses were removed from their packages and placed on each lens support while the support was submerged in the packaging solution to allow complete wetting and the lens was mounted centered on the support. The lens support and lens are submerged in the packaging solution chamber for at least 5 seconds to ensure complete submersion without air bubbles remaining under the lens. The lens holder is slowly lifted from the chamber and placed on a support similar in size to the solution chamber, but with only two sides supporting the handle. The lens holder was allowed to drain for about 10 seconds (until drain stop change) before drainage and lens transfer were evaluated. Photographs were taken and evaluated for lens centration, fluid area captured between the lens support arm and the lens, and lens deformation.
To ensure a consistent tap surface and to simulate low adhesion fingers, rubber nitrile gloves were worn on the hands used for the tap test. The test was repeated at least 5 times for each support design, with the lenses being replaced after 2 repetitions.
The results are shown in table 6 along with representative photographs and CAD drawings showing the lens support configuration.
Drainage and therefore tapping is better when a vertical or high angle fluid film is formed between the lens and the drainage reservoir (packaging or base of the testing device) and breaks before tapping. Example 15 a fluid film was formed between the lens periphery and the lower peripheral ring and drained well. Comparative example 10 and comparative example 9 did not form a vertical film and, despite having a very similar geometry to example 15, drainage was poor. The lens support of example 15 has a flat top section and a straight side section, 7mm wide at the elbow, providing good drainage, with minimal lens-lens support contact, which provides a consistent first transfer (80%) when the finger is tapped.
In the case of premature film failure in example 15, the lens also did not drain.
Horizontal membranes are not sufficient for drainage. In comparative example 8, a film was formed between the lens and the outer ring, however the lens still did not drain. Horizontal films also tend to be more difficult to break, thus impeding lens removal.
Examples 17 to 2 and comparative example 11
ACUVUE oasis 1Day lenses were packaged in polypropylene packages having the general configuration shown in fig. 5A (polypropylene lid with polypropylene lens support secured to laminated foil base, with a cavity volume of about 1150 μ L). The lenses were sealed in packages with the buffer solution as shown in table 8, steam sterilized at 121 ℃ for 18 minutes with the package base at the bottom and the lid at the top ("foil up"). The lenses were held in a foil up configuration at room temperature. RMS was for each lens and the results are shown in table 10 below. The number of samples used for each packaging solution is listed in the second column of table 10. The control lens was an acuue OASYS1Day lens in its original unopened package, which was re-sterilized with the lenses of examples 17-20. The RMS values were measured and reported as mean values.
TABLE 10
As the volume of the packaging solution increases to the maximum fill value, both the magnitude and variability of the RMS value decrease, and the bubbles decrease accordingly. With the dome on top and the lens in a convex position, the bubbles settle on and interact with the optical zone of the contact lens, inducing optical distortion, as shown by the higher and more easily changing RMS values of examples 17 and 18. The volume of solution in example 20 filled the cavity, so no bubbles interacted with the contact lens, and the example 20 lens showed a mean RMS of 0.029 +/-0.008. Example 19 also showed acceptable RMS values, although they were more easily changed than the lenses of example 20. A contact lens wearer may notice deformation with an RMS value of about 0.1.
The polypropylene will allow some air to diffuse into the packaging cavity over time, so that air bubbles may form during storage even if the cavity is filled with packaging solution (without air bubbles). A package having a foil as an outer layer prevents the formation of bubbles.
The invention includes the following embodiments/elements/features in any order and in any combination.
1. A contact lens package, comprising:
a support for holding a contact lens in a convex position on the support during storage and when opening the package; wherein
The lens has a peripheral edge and a lens contour;
the contour of the support and the lens contour do not substantially match; and a wet contact between the support and the lens is less than about 20mm 2 Less than 18mm 2 Or less than 15mm 2 。
2. A contact lens package, comprising:
a packaging base;
a packaging cover; and
a support for holding a contact lens having a peripheral edge and a lens profile in a convex position relative to the package base;
wherein the base and lid are sealed to form a cavity containing the support, contact lens, and packaging solution;
wherein the lens support comprises a plurality of peripheral supports having distal ends that extend at least 1mm beyond the contact lens peripheral edge and providing at least 3, 3 to 14, 4 to 14, 3 to 8, or 4 to 8,4 to 6, or 6 contact points with the contact lens edge along the peripheral supports, and the wet contact between the supports and the lens is less than about 20mm after the package has been opened and the packaging solution has been directed away from the lens and supports 2 Less than 18mm 2 Or less than 15mm 2 。
3. The contact lens package of claim 1 or 2, wherein the support allows the packaging solution to drain from the lens and support without trapping packaging solution between the lens and lens support when removed from the packaging solution.
4. The contact lens package of claim 1 or 2, wherein the lens further comprises an optical zone and the lens support further comprises a substantially flat top section having an open structure underlying at least a portion of the contact lens optical zone.
5. The contact lens package of claim 1 or 2, wherein the support further comprises a void located below at least a portion of the contact lens optical zone.
6. The contact lens package of claim 1 or 2, wherein the contact lens remains in an uncompressed state when the package is sealed.
7. The contact lens package of claim 1, wherein the support comprises at least two peripheral supports.
8. The contact lens package of claim 2 or 7, wherein the peripheral support is distributed around the lens periphery.
9. The contact lens package of any one of the preceding claims, wherein the lens comprises an apex centered in the optical zone, the support further comprising a central support having a height measured from the lens periphery no greater than 0.5mm below the contact lens apex.
10. The contact lens package of claim 9, wherein the central lens support further comprises a diameter of about 1mm to about 10mm, about 3mm to about 9mm, about 5mm to about 9mm, or about 6mm to about 9mm.
11. The contact lens package of claim 9 or 10, wherein the central lens support has an open structure.
12. The contact lens package of claim 11, wherein the central lens support comprises a central column located below the lens vertex.
13. The contact lens package of claim 11, wherein the central lens support comprises a plurality of arms, each arm comprising:
a flat top section, an optional side section, and an optional peripheral support, a shoulder transition connecting the top and optional side sections, and an optional elbow transition connecting the optional side and optional peripheral support.
14. The contact lens package of claim 13, wherein the plurality of arms in the flat top section are connected to each other at a center point below the lens vertex, or to an open full or partial ring centered below the lens vertex.
15. The contact lens package of claim 13, wherein the plurality of arms are in the form of fins connected to the package base.
16. The contact lens package of claim 13, wherein one end of at least some of the plurality of arms is attached to the peripheral lens support and protrudes upward, and distal ends of the arms form the flat top section.
17. The contact lens package of any one of the preceding claims, wherein at least some of the distal ends of the peripheral support are connected to vertical supports that lift the peripheral support from the lens base.
18. The package of claims 2-17, further comprising an at least partial ring around the distal end of the peripheral support, the at least partial ring extending at least 2mm beyond the contact lens peripheral edge.
19. The package of claims 13-18, further comprising three to eight arms.
20. The package of claims 13-18, further comprising three to six arms.
21. The package of claims 13-20, wherein at least two of the arms have a Y-shape.
22. A package according to claims 13 to 20 having 3Y-arms.
23. The package of claims 13-20, comprising 2 straight arms and 2Y-shaped arms.
24. The package of claims 21-23, wherein the Y-shaped arm comprises a curve across a top portion of the Y.
25. The package of any of claims 13-20, wherein the arm is straight.
26. The package of claim 18, wherein at least a portion of the ring has a diameter of between about 16mm and about 25mm, between about 18mm and about 25mm, or between about 18mm and about 24 mm.
27. The package of claim 4, wherein the substantially flat top portion has a deflected height in an undeformed state of 0.5mm, about 0.5mm to about 2mm, 0.5mm to about 1.5mm, or about 0.8mm to about 1mm from the contact lens vertex.
28. The package of any of claims 9 to 27, wherein the support further comprises a central fillet centered on the flat top section, the central fillet having a width in its longest dimension of about 0.1mm to about 3mm, about 0.1mm to about 2mm, or less than 1.5mm.
29. The package of claims 13-28, wherein each of the arms and perimeter supports has a width of about 0.5mm to about 1.5mm, about 0.5mm to about 1mm, or about 0.5mm to about 0.7 mm.
30. The package of claims 13-29, wherein the arms have a width that provides part moldability and effective drainage of packaging solution when opened.
31. The package of claims 13-30, wherein each arm has a height at the flat top section of about 0.5mm to about 5mm.
32. The package of any of claims 9-29, wherein the flat top has a center point at the center of the lens support, and the shoulders are disposed radially about the flat top center.
33. The package of claim 32, wherein the arms are attached at the center point and each arm has a length from the shoulder to the center point of about 1.5mm to about 4mm.
34. The package of any of claims 9-33, wherein the angle from vertical at the flat top and side sections of the arm is up to about 15 ° or between about 1 ° and about 10 °.
35. The package of any of the preceding claims, wherein the angle between the side section and the peripheral support is between about 60 ° and about 120 ° or between about 80 ° and about 100 °.
36. The package of any of the preceding claims, wherein the arms are connected at the center of the flat top portion.
37. The package of any of the preceding claims, wherein the arms are radially distributed about the center of the support structure.
38. The package of any of the preceding claims, wherein the base is substantially flat.
39. The package of any of the preceding claims, wherein the lens does not contact the arm side section.
40. The package of any of the preceding claims, wherein the arm side section is straight.
41. The package of any of the preceding claims, wherein at least one peripheral support is elongate and comprises an opening extending distally at or before the periphery of the contact lens to form a drainage channel for drainage of packaging solution from the contact lens and support structure.
42. The package of claim 41, wherein at least 2 peripheral supports are elongate and connected at their distal ends with an opening therebetween to form the drainage channel.
43. The package of claims 41 to 42, wherein the partial loop is connected to the elongated arm.
44. The package of claims 41 to 43, wherein the elongate arm is planar.
45. The package of claim 2, wherein the partial ring comprises an outwardly extending tab having an open drain channel for draining packaging solution from the contact lens and support structure.
46. The package of claims 41-45, wherein the drainage channel tapers toward the outwardly extending tab distal end, curves from the peripheral loop arc to the distal end, opens at the peripheral loop arc and tapers from the arc to the distal end.
47. The package of claims 41 to 45, wherein the drainage channel has straight walls.
48. The package of claims 41 to 47, wherein the drainage channel has a length measured from the arc of the peripheral ring of about 2.5mm to about 3.5mm.
49. The package of claims 41 to 47, wherein the drainage channel has a width of about 0.8mm to about 3mm wide.
50. The package of claims 41 to 47, wherein the drainage channel is tapered and has a width at the distal end of about 1mm to about 0.8mm wide.
51. The package according to any of the preceding claims, wherein the support is made of a polymer having a contact angle greater than 100 °.
52. The package of any of the preceding claims, wherein the lens support is disposed at an angle of at least about 20 ° from the package base.
53. The package of any of claims 2 to 52, wherein the peripheral support is parallel to the package base and at least about 4mm or at least about 5mm from the package base.
54. The package of any of the preceding claims, further comprising a means for lifting the lens support from the lens solution.
55. The package of claim 54, wherein the lifting device is selected from the group consisting of levers, springs, hinges, pivoting arms, folds, mechanical traps, handles, and combinations thereof.
56. A package according to claim 41, 42 or 45, wherein the lifting means comprises: the drainage channel fixedly attached to the package base at the drainage channel distal end; and a hinge line in the package base transverse to the drainage channel between at least a partial circumferential loop or arc formed by the distal end of the circumferential support and the fixed attachment point, the fixed attachment point being located between the drainage channel and the package base.
57. The package of claim 56, wherein if a peripheral ring is not included in the lens support, the hinge line exceeds the at least a portion of the peripheral ring or lens periphery by a length of at least 1mm, from about 2mm to about 4mm, or from about 2.5mm to about 3.5mm.
58. The package of claim 54, wherein the lifting device lifts the lens from the packaging solution by tilting the lens support and base away from each other to an angle of about 15 ° to about 80 °, about 20 ° to about 70 °, about 30 ° to about 60 °, or about 40 ° to about 60 ° relative to horizontal.
59. The package of any of the preceding claims, further comprising a reservoir for capturing packaging solution when the lens and support are separated from the packaging base.
60. A contact lens package, comprising:
a support for holding a contact lens having a convex surface in a convex position relative to the support; and
a lens-facing surface comprising at least one air intake guide configured such that, upon opening of the package by a user, the at least one air intake guide directs air into the package over the contact lens convex surface to reduce the incidence of the convex lens surface adhering to an inner surface.
61. The contact lens package of claim 60, wherein the package interior defines a cavity containing the support, at least one intake guide, a contact lens, and a packaging solution; and
when the package is opened and the packaging solution is expelled from the lens, but prior to contact by a user's fingers, the lens maintains a convex shape on the lens support, and the support contacts the lens at least two points distributed around the lens periphery.
62. The package of claim 60 or 61, wherein the lens has a contour and the contour of the support does not substantially match the lens contour.
63. The package of claims 60 to 62, wherein the support and the post-packaging are the sameThe contact area between the lenses is less than about 20mm 2 Less than 18mm 2 Or less than 15mm 2 。
64. The package according to any of the preceding claims, wherein the package further comprises a base comprising a laminated foil.
65. The package of claims 60-64, wherein the contact area between the at least one intake guide and the lens is less than about 50mm 2 Or less than about 30mm 2 。
66. The package of claims 60 to 65, wherein the air intake guide is integral with the lens-facing surface, as a protrusion therefrom, or a depression in the lens-facing surface.
67. The package of claims 60-65, wherein the air intake guide is part of a separate structure disposed between the convex lens surface and the cover lens facing surface.
68. A package according to claims 60 to 67, wherein the air intake guide is aligned parallel to the path of air entry when the package is opened.
69. The package of claims 60-68, wherein the intake guides are spaced apart by at least about 2mm, about 2mm to about 5mm, or 2mm to about 4.5mm.
70. The package of claims 60-69, wherein the contact lens comprises an optical zone and a curved lens side section between the optical zone and the peripheral edge, and the intake guide extends in a straight line from the front to the back of the package, curves around the optical zone, or a combination thereof.
71. The package of claim 70, wherein the intake guide traversing the optical zone has a shorter profile across the optical zone.
72. The package of claims 55 to 71, wherein the air intake guide comprises a continuous rib, a discontinuous rib, and combinations thereof.
73. The package of claims 60-72, wherein the air intake guide has a maximum height of at least about 2mm or from about 2mm to about 4mm.
74. The package of claim 71, wherein the intake guide profile on the optical zone has a height of about 0.5mm or less.
75. The package of claims 60 to 74, wherein the lid-facing surface is an interior surface of a package lid; and the package further comprises a base that forms, with the lid, the cavity containing the lens support, lens, and packaging solution;
the package further comprises: an opening tab for initiating said separation of said cover from said base along a sealing line forming said cavity; and an air inlet inside the seal line and aligned in line with the opening tab.
76. The package of claim 75, wherein the air intake protrudes at least about 1mm or at least about 2mm from the perimeter of the contact lens edge.
77. The package of claim 75 or 76, wherein the air inlet has a width of between about 2mm and an inner diameter of the seal.
78. The package of claims 75-77, further comprising an opening tab for initiating said separation of said cover from said base along a sealing line forming said sealed cavity, wherein there is a gap of at least about 2mm between said sealing line and a lens support at said opening tab.
79. The package of claims 75-78, wherein the intake tab further comprises at least one intake guide.
80. The package of claims 60-79, wherein the lens support, lens-facing surface, and at least one intake guide cooperate to keep the lens centered about the support with minimal contact between the lens, the support, and at least one intake guide.
81. The package of claim 80, wherein contact between the lens, the at least one intake guide, and the support is transient.
82. The package of claims 60-81, further comprising an air capture space remote from the lens optic zone for occupation by air in the cavity.
83. The package of claim 82, wherein the air is retained in the air capture space away from the lens regardless of package orientation.
84. The package of claims 82-83, wherein the volume of the air capture space is equal to or slightly greater than the volume of air to be sealed in the package.
85. The package of claims 82-83, wherein the volume of the air capture space is equal to or slightly greater than the volume of air sealed in the package and any air that can diffuse into the package during storage.
86. The package of claims 75-85, wherein the cover comprises a concave dome over the lens and lens support, the concave dome comprising a depression centered over the lens support.
87. The package of claims 82-87, wherein the air capture space comprises a channel around the circumference of the lid inside the seal.
88. The package of claim 86, wherein the air capture space is disposed circumferentially around the recess.
89. The package of claims 82-86, wherein the air capture space comprises at least two air compartments box projecting from the lid along the perimeter of the lid inside the seal.
90. The package of claim 88, further comprising one, two, three, or more air compartment boxes projecting from the lid along the inside of the seal line.
91. The package of claim 88, wherein the air tank box is linear, arcuate, or a combination thereof.
92. The package of claim 90, comprising two planar air-compartment boxes spaced across the lid and oriented parallel or perpendicular to the opening tab.
93. The package of claims 82-92, wherein the air compartment boxes are connected via a connecting channel.
94. The package of claim 93, wherein the air compartment box is wider, taller, or both wider and taller than the connecting channel.
95. The package of claims 93-94, wherein the channel has an interior width of about 1.5mm to about 3mm or about 2mm to about 3 mm.
96. The package of claims 60-95, comprising a gap of at least about 0.25mm and about 2mm between the lens optical zone and any air entry guide or pocket when the package is sealed.
97. The package of any of the preceding claims, wherein the base and lid are a single, unitary component.
98. The package of any of the preceding claims, wherein the base and lens support are a single, unitary component.
99. The package of any of the preceding claims, wherein the base, lens support, and cover are a single, unitary component.
It is intended that this invention be defined by the following claims and their equivalents.