EP4210537A2 - Single touch contact lens case - Google Patents
Single touch contact lens caseInfo
- Publication number
- EP4210537A2 EP4210537A2 EP21783353.2A EP21783353A EP4210537A2 EP 4210537 A2 EP4210537 A2 EP 4210537A2 EP 21783353 A EP21783353 A EP 21783353A EP 4210537 A2 EP4210537 A2 EP 4210537A2
- Authority
- EP
- European Patent Office
- Prior art keywords
- lens
- case
- support
- contact
- base
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Pending
Links
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- NLAIHECABDOZBR-UHFFFAOYSA-M sodium 2,2-bis(2-methylprop-2-enoyloxymethyl)butyl 2-methylprop-2-enoate 2-hydroxyethyl 2-methylprop-2-enoate 2-methylprop-2-enoate Chemical compound [Na+].CC(=C)C([O-])=O.CC(=C)C(=O)OCCO.CCC(COC(=O)C(C)=C)(COC(=O)C(C)=C)COC(=O)C(C)=C NLAIHECABDOZBR-UHFFFAOYSA-M 0.000 description 1
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Classifications
-
- A—HUMAN NECESSITIES
- A45—HAND OR TRAVELLING ARTICLES
- A45C—PURSES; LUGGAGE; HAND CARRIED BAGS
- A45C11/00—Receptacles for purposes not provided for in groups A45C1/00-A45C9/00
- A45C11/005—Contact lens cases
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
- B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
- B65D2585/00—Containers, packaging elements or packages specially adapted for particular articles or materials
- B65D2585/54—Containers, packaging elements or packages specially adapted for particular articles or materials for articles of special shape not otherwise provided for
- B65D2585/545—Contact lenses
Definitions
- Design of a single touch lens case faces some distinct challenges.
- the user ideally should be able to consistently position the lens to adhere to the finger during removal from the case, and then the lens needs to consistently release from the finger onto the eye.
- Contact lenses (of both the reusable and daily disposable variety) each have their own unique surface, bulk and geometric properties. Finger size and the force a contact lens wearer imparts on the lens during transfer can also vary. These factors can impact the process for taking the lens from the case onto the finger and then onto surface of the eye. Among other considerations: it would be desirable for users to be able to drain away any lens solution which might impact the ability of adhering the lens to the finger, as variation in the amount of lens solution adhering to the lens and case can impact the process of placing the lens on the finger.
- the wearer may be concerned about the potential of transferring bacteria or external products such as make up to the contact lens; and of course, manufacture of the case itself should conform to expected industry standards recognized by the medical and commercial provider communities.
- manufacture of the case itself should conform to expected industry standards recognized by the medical and commercial provider communities.
- the single touch case ideally should not result in an inordinate increase in the cost of goods over current contact lens cases, as this could result in increased costs to the user community.
- the case should not make it difficult to hold the lens when removed from the case. Additionally, if the configuration of the case were to maintain, or even reduce the volume of solution needed to case the lens, this would reduce the ecological impact of the lens case. Similarly, it would be beneficial if all or part of the case could be made of recycled materials, and/or recyclable in whole or part.
- the case were composed of materials that are already approved by the various regulatory bodies and ideally did not require a change in solution chemistry or lens composition.
- the functionality of the case preferably does not incorporate any electronics or other electrical components, if such components could adversely affect performance of either the case or the lens.
- the lens case ideally should protect the lens. It should ensure the lens’s integrity, while at the same time prevent crushing or damage to the lens.
- the lens case should maintain the hydration of the lens when stored. This will maintain the lens's properties.
- the lens in its case should be configured so that when desired, it is fully submerged in the lens solution, yet be cleared of such solution when ready to be transferred to the wearer’s finger.
- the case preferably should maintain lens in the desired convex orientation to the wearer.
- the lens should be correctly positioned on the lens support so that it can be easily removed by the user.
- the lens case should allow the lens solution to be effectively drained away from the lens upon opening of the case and prior to lens removal, to enable easier transfer to the wearer’s finger and then onto the eye.
- US20190046353 discloses contact lens storage containers that facilitates an increased ease of lens removal. However, the case requires the user to pour out the lens solution and has curved support ribs that do not provide the desired consistent one touch removal.
- US20200229560 discloses cases with lens supports that support the concave (anterior or front) surface of the contact lens, or grates that support the contact lens peripheral edge and allows lens solution to drain through a grate to a bottom chamber upon opening the lens case.
- the cases of the present invention provide improved functionality during storage, drainage, lens transfer and reusability that enable consistent one touch transfer of the lens from the lens case to the wearer’s finger.
- the one touch feature includes the following features individually and in combination:
- the lens is fully submerged in the lens solution during storage, and the lid and base form a water tight seal when fully closed.
- the lens support and lid interior may be designed so that the lens optic zone does not permanently rest on any feature/structure to prevent distortion.
- the lens support is designed to maintain the lens in the desired convex orientation, but minimize contact between the lens and lens support to provide good drainage, such that the lens solution is clear of the lens upon opening, without fluid bridging to the lens or pooling around areas of contact between the lens and support. Because the case is reusable, it is desirable it should be easy to use. It should be easy for the lens wearer to place the lens in the case, fill the case with the correct level of solution to ensure lens submersion, and to open, dose, dean, drain and dry the case.
- the lens case structures and features in the case may also be designed to minimize microbial build-up.
- the present invention relates to a contact lens case comprising a support for maintaining a contact lens in a convex position on the support during storage and upon opening the case; wherein the lens has a peripheral edge and a lens profile; the support has a profile that does not substantially match the lens profile; and wetted contact between the support and the lens is less than about 20 mm 2 , less than 18mm 2 or less than 15 mm 2 .
- the present invention further relates to a contact lens case comprising a base; a lid; and a support for holding, in a convex position relative to the base, a contact lens having a peripheral edge and a lens profile; wherein the base and lid are sealed to form a cavity comprising the support, contact lens and packaging solution; wherein the lens support comprises a plurality of peripheral supports which have a distal end extending at least 1 mm beyond the contact lens peripheral edge and provide at least 3, 3 to 14, 4 to 14, 3 to 8 or 4 to 8, 4 to 6 or 6 points of contact with the contact lens edge along the peripheral supports and wetted contact between the support and the lens after the case has been opened and the packaging solution has been directed away from the lens and support, is less than about 20 mm 2 , less than 18mm 2 or less than 15 mm 2 .
- the present invention further relates to a contact lens case comprising a support for holding, in a convex position relative to the support, a contact lens having a convex surface; and a lens facing surface comprising at least one air entry guide configured such that, upon opening the case by a user, the at least one air entry guide guides air entering the case over the contact lens convex surface to reduce the incidence of the lens sticking to the interior surface.
- Figures 1A-R are drawings of various lens support configurations.
- Figures 2A-C are drawings of a contact lens cases showing various lens support and lifting means.
- FIGS 3A-J are drawings of lids showing examples of air flow management features within present invention.
- Figures 4A-C are drawings showing contact lens cases within the present invention.
- Figure 5A is an exploded side view of a lens case of the present invention.
- Figure 5B is n side view of the lens case shown in Figure 5A.
- FIGS 5C-F are drawings of lens cases of the present invention.
- the present invention relates to cases for contact lenses, such as hydrogel contact lenses that permit the user to remove the contact lens from the case with the touch of a fingertip at or near the apex of the contact lens.
- the lens once transferred to the fingertip is in a position suitable for placement by the wearer on the eye, thereby simplilying lens removal from the case and insertion on the eye.
- a benefit of the lens cases of the present invention is that they provide consistent one-touch lens transfer from the case to a wearer’s finger, and then from the finger to the wearer’s eye without the lens inverting, falling off the finger or further manipulation. Consistent lens transfer includes a transfer rate of at least about 70%, at least about 80% or at least about 90% transfer on the first touch of the finger (or “dab”). The lens also desirably “sits up” on the finger without collapsing or inverting and then transfers to the eye when placed there. Cases of the present invention may provide the desired one-touch transfer across a range of finger sizes, and dab pressures. Environmental conditions such as the temperature and whether the finger is wet or dry may also impact transfer rate, with higher temperatures generally improving lens transfer. Lens transfers evaluated in the present invention were conducted at room temperature.
- Contact lenses refers to ophthalmic devices that reside on the eye. They have a generally hemispheric shape and can provide optical correction, cosmetic enhancement, UV blocking and visible light or glare reduction, therapeutic effect, including wound healing, delivery of drugs or neutraceuticals, diagnostic evaluation or monitoring, or any combination thereof.
- the term lens includes soft hydrogel contact lenses, which are generally provided to the consumer in a case in the hydrated state, and have a relatively low moduli, which allows them to conform to the cornea.
- Contact lenses suitable for use with the cases of the present invention include all hydrated contact lenses, including conventional and silicone hydrogel contact lenses.
- a hydrogel is a hydrated crosslinked polymeric system that contains water in an equilibrium state, and may contain at least about 25%, or at least 35% water in the hydrated state. Hydrogels typically are oxygen permeable and biocompatible, making them excellent materials for producing contact lenses.
- Conventional hydrogel contact lenses do not contain silicone containing components, and generally have higher water content, lower oxygen permeability, moduli and shape memories than silicone hydrogels.
- Conventional hydrogels are prepared from monomeric mixtures predominantly containing hydrophilic monomers, such as 2-hydroxyethyl methacrylate (“HEMA”), N-vinyl pyrrolidone (“NVP”) or polyvinyl alcohols.
- HEMA 2-hydroxyethyl methacrylate
- NDP N-vinyl pyrrolidone
- United States Patents Nos. 4,495,313, 4,889,664 and 5,039,459 disclose the formation of conventional hydrogels.
- Conventional hydrogels may be ionic or non-ionic and include polymacon, etafilcon, nelfilcon, ocufilcon lenefilcon and the like.
- the oxygen permeability of these conventional hydrogel materials is typically below 20-30 barrers.
- Silicon hydrogel formulations include balafilcon samfilcon, lotrafilcon A and B, delfilcon, galyfilcon, senofilcon A, B and C, narafilcon, comfilcon, formofilcon, riofilcon, fanfilcon, stenfilcon, somofilcon, kalifilcon and the like.
- Silicone hydrogels refer to polymeric networks made from at least one hydrophilic component and at least one silicone-containing component. Silicone hydrogels may have moduli in the range of 60- 200, 60-150 or 80 -130 psi, water contents in the range of 20 to 60%.
- silicone hydrogels indude acquafilcon, asmofilcon, balafilcon, comfilcon, delefilcon, enfilcon, fanfilcon, formofilcon, galyfilcon, lotrafilcon, narafilcon, riofilcon, samfilcon, senofilcon, somofilcon, and stenfilcon, induding all of their variants, as well as silicone hydrogels as prepared in US Patent Nos.
- Hydrogel lenses are viscoelastic materials. Contact lenses can form optical distortions if the lens interacts with either the case or any air bubble in the case. The extent of the optical distortions, and the length of time needed for the distortions to relax out will vary depending on the chemistry, and to a lesser extent, geometry of the lens. Conventional lens materials, such as polyhydroxyethyl methacrylate-based lenses like etafilcon A or polymacon have low loss modulus and tan delta compared to silicone hydrogels, and may form fewer and less severe optical distortions as a result of contact with packaging.
- silicones which generally increase the bulk elastic response
- wetting agents such as PVP (which generally increase the viscous response)
- coatings such as plasma coatings or conventional hydrogel materials (which may lower the elastic response at the lens interface)
- conventional hydrogel contact lenses and silicone hydrogel contact lenses having short or stiff crosslinking agents and or stiffening agent have short shape memories and may be less susceptible to deformation during storage.
- high or higher shape memory hydrogels display optical distortions from contact with an air bubble or case of at least about 0.18 after 5 weeks of accelerated aging at 55°C. Viscoelastic properties, including loss modulus and tan delta, can be measured using a dynamic mechanical analysis.
- the contact lenses can be of any geometry or power, and have a generally hemispherical shape, with a concave posterior side which rests against the eye when in use and a convex anterior side which faces away from the eye and is contacted by the eyelid during blinking.
- the center of the lens is the center of the lens optic zone.
- the optic zone provides optical correction and may have a diameter between about 7 and about 10 mm.
- the lens optic zone provides visual correction.
- the lens periphery or lens edge is the edge where the anterior and posterior sides meet.
- the wetted lens is the contact lens and any residual solution attached to it after lens solution drainage.
- Wetted contact is the aggregated contact area between the wetted lens and lens support.
- the contact lens case comprises a lens support surrounded by a reversible sealable chamber.
- the chamber may have any convenient form and may comprise a base which may have one or multiple compartments or base segments, lens support and at least one lid, each of which are described in detail below.
- the phrases ‘the lid”, “a lid”, ‘the base” and “a base” encompass both the singular and plural.
- the lid and case base are sealed to each other to form a watertight cavity which holds the contact lens, support and lens solution in during cleaning and storage.
- the contact lens case is made from materials which are compatible with the contact lens and solution, as well as biologically inert.
- Lens cleaning or multipurpose solution is any physiological solution compatible with the selected lens material and case.
- Lens solutions include buffered solutions having a physiological pH, such as buffered saline solutions.
- the lens solution may contain known components, including buffers, pH and tonicity adjusting agents, lubricants, wetting agents, nutraceuticals, pharmaceuticals, in case coating components and the like.
- the case base forms the bottom of the case. It can be made from any material suitable for packaging medical devices, including plastic.
- the bottom of the lens support is disposed on and supported by the base surface facing into the case cavity.
- the lens support may also be integral with the base.
- the lens support may rest on the inner surface of the case 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.
- 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 level.
- the lid forms the uppermost structure of the case and seals with the base to form a cavity containing the lens support, lens, lens solution and any other incorporated features.
- the lid may be made from any material suitable for packaging medical devices, including a flat or molded sheet of foil or plastic, laminate films, or plastic. Cases comprising plastic for one structure and foil or laminated films as the other, or cases comprising plastic for the lid and base are known in the art and are examples of suitable combinations.
- the lens support keeps the lens in the desired convex orientation (bowl down relative to the base) and position (centered over the support) during storage.
- the lens support is designed to provide an open structure under the lens bowl to allow, upon opening, the lens solution to drain from the lens and support without trapping water between the support; and a sufficient number of contact points with the lens to prevent the lens from collapsing onto, rotating off or translating across the support. This allows the apex of the lens to be supported by the lens' own elastic stiffness, or to minimize sinking of the lens apex while limiting the contact area between the support and lens.
- the sum of the contact between the lens and the lens support when the case is open, and the solution drained from the lens and lens support is the total contact area, which may be less than about 20 mm 2 , less than 18mm 2 or less than 15 mm 2 and is distributed at least around the lens periphery, as described herein.
- the lens support may be designed to limit contact between the lens and support during storage. Such contact may be distributed around the lens peripheral edge. Contact between the lens optic zone, lens support and lid interior (including any air entry guides) may be transitory or there may be no contact between the optic zone and support, lid or air entry guides. Lenses, such as conventional hydrogels, having shorter shape memory, are less prone to distortion from packaging contact, and can have the contact points distributed around the periphery and throughout the lens profile, including the lens center zone (about 9mm, or about 5 mm diameter).
- the lens supports of the present invention allow, upon dabbing, both the fingertip and lens to deform to match each other's shape, without causing lens inversion or damage to lens during removal from too much pressure during dabbing.
- an aspect of the removal of the lens from the present cases is to control the ratio of the contact area between the finger and lens as compared to the area between the lens and the lens support so that the contact area between the finger and lens exceeds the contact surface area of the lens support on the lens underside. This will ensure that surface tension between finger and lens exceeds surface tension between lens and lens support. Thus, the lens will adhere to the finger for lens transfer and placement onto the eye.
- Figures 1 A-P show examples of lens supports useful with the present invention. Each of these lens supports may be useful with any of the cases described herein.
- the lens support may provide a light resistive force on the lens during lens transfer to allow the lens to be adhered to the finger.
- the lens support may be designed in a range of configurations. It should be appreciated that the configurations depicted herein are illustrative examples. Configurations not illustrated or those that combine 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, at least 3, 3 to 14, 4 to 14, 3 to 8 or 4 to 8, 4 to 6 or 6 points of contact with the contact lens edge along the peripheral supports 105.
- the peripheral points of contact prevent the lens from rotating off the lens and can be distributed in a number of configurations, as long as the space between the furthest adjacent contacts is less than the diameter of the lens.
- the contacts may be arranged in an acute triangle as shown in Example 16. All ( Figures 1B, C, H, K and L) or most ( Figures 1M-0) of the peripheral supports can be evenly distributed around the lens periphery.
- Peripheral supports with less than 50% open space such as those in the form of a screen or strainer, generally provide insufficient drainage to insure one touch transfer.
- Supports in the shape of a convex dome, whether formed with ribs, solid or perforated domes generally provide too much contact area with the lens and inconsistent drainage.
- Figure 1G shows a lens support comprising 6 planar peripheral supports 105 which join in the center of the lens support and extend outward to an unsupported distal end.
- Channel members 115 are one structure which may be used to help facilitate lens solution drainage and are discussed in detail, below.
- the peripheral supports 105 provide a path for lens solution to drain from the lens when the case is opened.
- the peripheral supports are generally transverse to the lens edge, which helps prevent the lens from wrapping around the support, linear and may extend outward to a distance at least 1 mm beyond the contact lens peripheral edge. If the distal ends of the peripheral supports extend less than 2mm beyond the lens edge, lens solution may be undesirably trapped under the lens, potentially interfering with effective lens transfer.
- the central peripheral ends (such as the “V" notches of the peripheral support 105 in Figure 1D) are not connected to a center support, they may extend in toward the center of the support at least about 3mm from the contact point with the lens, as illustrated by the exemplary configuration of Figure 1 D. If the peripheral supports extend less than 3mm from the lens contact point in toward the lens, the lens may slide off the peripheral support.
- the peripheral supports 105 may be radially disposed around the center of the support. They may attach to each other as shown in Figure 1G, or at an elbow 104 as the terminal portion of a lens support arm as shown in Figures 1 A and B. Peripheral supports 105 may extend inward from an at least partial peripheral ring 109 as shown in Figures 1C and 1D. And, peripheral supports 105 may connect to a central column or cylinder 107 as shown in Figure 1 E, or any combination of the foregoing. When the peripheral supports extend inward, they may meet in a single central point (Figure 1G), column, or cylinder 107 (Figure 1E), may meet adjacent peripheral supports to form an open center as is shown in Figure 1 D.
- one or more of the peripheral supports 105 may extend inward from their distal end at the at least partial peripheral ring to an unsupported proximal end inside the circumference of the lens or to another point on the peripheral ring, as shown in Figure 1 C.
- the peripheral supports may be planar, as in Figures 1B-G or may be angled as in Figure 1A. When angled, the angle may be from 0° to about 30°, or 0° to about 15° from level, and may slope toward the center of the support or the distal end of the peripheral support.
- FIG. 1 D shows a lens support comprising a partial peripheral ring 109 with planar peripheral supports 105 in the form of an open, six-armed asterisk shape, radially disposed around the center of the lens support. Because the lens cases are used repeatedly for weeks or months, lens supports which are more robust may be preferred. Lens supports with full peripheral rings, peripheral columns or lens supports which are integrally molded into the base may be preferred. Examples of such supports are show at Figures 1 H, 1 K- R.
- a full or partial peripheral ring When a full or partial peripheral ring is included it may have a diameter at least 4 mm larger than the contact lens (at least 2 mm from all contact lens edges) to fadlitate drainage of the lens solution away from the lens and lens support.
- the diameter of the at least partial peripheral ring may be centered around the center of the lens support and is measured across opposite partial peripheral ring sections 109.
- Peripheral ring diameters of between about 16 and about 25 mm, about 18 and about 25 mm or about 18 and about 24 mm will be suitable for commercially available contact lenses.
- the peripheral ring when included, may rest on the base during storage, may be fixedly attach to the base, or may attach to vertical supports 147 such as feet, stilts 110 as shown in Figure 1 K and 1 P, a raised base fin section (Figure 1 H), a central column or cylinder 107 as shown in Figure 1Q which keep it raised from the base.
- the vertical supports may extend about 4 to about 5 mm from the base for a horizontally disposed lens support, or about 2 to about 5mm, about 2.5 to about 5mm or about 3 to about 4mm for a lens support which is tilted when the case is closed, such as the tilted lens support depicted in Figure 1 H .
- the vertical supports When included, the vertical supports may be of the same length or may be of different lengths to maintain the lens at an angle relative to level.
- the upper limit of the height of vertical supports is limited by the desired size of the case, as increasing the length of the vertical supports increases the height of the overall case and the amount of solution required.
- a peripheral ring may also attach to a lifting or pivot structure, such as a lever or an extended channel member, described below, to facilitate raising the lens support from the base, to help drain lens solution away from the lens.
- the case base may also be designed such that the peripheral supports 105 (shown as part of a raised fin in the example embodiment of Figure 1 H) are level with each other, but the base floor 120 and lens support 136 are disposed at an angle (Figure 1 H).
- the lens support may be a separate structure or may be part of the base as shown in Figure 1H.
- the lens support may further comprise at least one positioning structure (not shown) to prevent the lens from translating horizontally across the lens support, particularly for supports disposed at an angle in the case or upon opening and removal.
- positioning structures include be notches, prongs or stops along the peripheral support outside the lens periphery, an open central support (described below), positioning pins or tabs inside the lens near the periphery of the lens, where the lens surface is more steeply angled, such as located outside the central zone of the lens (diameter of about 5 mm, about 6 mm, or about 7 mm), or a combination thereof.
- the lens support may further comprise an open structured central support to provide additional resistance, drainage pathways and/or to increase the contact area between the finger and the lens during lens transfer.
- the profile of the central support may be designed to keep the lens in the convex position preferably centered on the support during shipping and storage without significant contact, and provide the desired lens contact area after drainage and prior to contact by the user’s finger.
- the central support may 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 the finger and the finger pad to be flattened, creating the desired bias in surface area.
- the central support may be flat or may be slightly concave, preferably provides at least 0.5 mm between the lens apex and the top of central support upon draining (to minimize contact between the lens apex and the support) and provides 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”).
- the central support may have a slightly concave curve with a radius of curvature of at least about 10mm or at least about 6 mm, or less desirably a slightly convex curvature of about 10 mm or higher. It may be desirable to design the central support so that it does not contact the lens optical zone until lens transfer.
- the top of the central support may have a diameter of about 1 mm to about 10 mm, about 3 mm to about 9 mm, about 5 to about 9 mm, or about 6 about 9 mm. For central supports having flat top regions with diameters less than about 5 mm, additional positioning structures may be desirable.
- the central support top may be oriented parallel to the lens periphery to form a column as shown in Figures 1 A-1 F. The central support top also provides resistance against the finger as the user presses down on the apex of the lens to initiate lens transfer.
- the central support may be formed from a plurality of arms.
- the arms may form a flat top section 101 , and be supported by one or more columns 108 extending up from the base, as shown in Figure 1 J; at least one peripheral support 105 as shown in Figure 1 A, B, C, E, F; at least one arm as shown in Figure 1D; or vertical supports 110, in the form of fins as shown in Figure 1 H or open supports 110 as shown in Figure 1 K.
- the arms may include an optional side section 103, a shoulder transition 102 connecting the flat top 101 and optional side 103 sections, peripheral supports 105, an optional elbow transition 104 connecting the optional side 103 and peripheral support 105.
- the flat top section of the arms may connect in the center at point 106 as is shown in Figures 1A and 1B; a column108 as in Figure 1i, ring or may connect to an open full or partial cylinder 107 as is shown in Figure 1 E, or the arms may connect to the case base, either as solid fins with a void 106a in the middle of the substantially flat top 101 (Figure 1 H).
- the arms may also attach to the bottom of the lens support, as shown in Figure 1 K, which has 6 arms with curved side sections 103, and a flat top section 101 formed by the upward facing ends of the arms.
- the distal end of the peripheral support 105 may also be connected to individual supports from the base as shown in Figure 1 K and 1 P, may be connected to a hollow column as in 1 Q, or directly to the base as in Figures 1 L and 1 R.
- the fins, the base or both may also be hollow to minimize the amount of packaging material used. Hollow or solid fins also displace lens solution, reducing the amount needed.
- the arms may be radially distributed around the center of the support structure.
- the flat top section may also comprise an optional central fillet 106a centered in the flat top section as shown in Figures 1 A, 10 and 1 N.
- the central fillet may be included in lens supports with or without a central column, such as Figure 1N and 1A, respectively. When a central fillet is included, it can have a width across its longest dimension of about 0.1 to about 3mm; about 0.1 to about 2mm, or less than 1.5mm.
- the central fillet can have any shape, including a circle with a smooth or scalloped edge, triangle or square.
- the points of the triangle or square may be located on the arms, offset from the arms and may be rounded or pointed.
- the side sections 103 may have any shape that provides minimal contact, and preferably no contact with the contact lens upon packaging opening and drainage, such that upon lens transfer the desired contact area differential is achieved.
- the side sections may be straight (non-curved), as is shown in Figures 1B through F.
- the lens may also have no side supports, as shown in Figure 1 J, where the flat top section 101 is supported by a central column 108. As solution drains, the lens may collapse toward central support.
- lens support profiles which do not substantially match the lens profile include central support profiles which provide clearance between the lens and side support (if present) of at least that provided by straight angled side sections with an outward angle from vertical of no more than about 10", including central supports which have no side sections, or a concave curve in the side section. It will be appreciated that lenses with higher moduli (such as silicone hydrogels) may deform less and may require central supports with less mismatch.
- the height of the flat top section (when included) is measured from the point of contact between the lens and peripheral supports to the top of the shoulder and can vary depending on the saggital depth and curvature of the contact lens. For effective transfer at least about 0.5 mm, about 0.5 to about 2 mm, 0.5 to about 1.5 mm, or about 0.8 to about 1mm of deflection from the undeformed contact lens apex may be desirable. For a contact lens having a saggital depth of 3.8 mm, flat top portions having a height of about 2 mm to about 3.3 mm, about 2.5- 3.3mm, or about 3 to about 3.5mm may be used.
- Removing the central column and leaving a void in the center can also provide the desired lens transfer, particularly with lenses with a neutral shape after drainage.
- the void can have a diameter between about 5 mm and the diameter of the lens (which provides a support with only peripheral supports as in Figures 1 F and 1 M).
- the void can be clear to or below of the base of the lens.
- the void is desirably at least 5 mm throughout to provide adequate drainage.
- Any structure below the void preferably has a low surface area so as not to interfere with lens solution drainage.
- a void extending to the base of the lens at least about 50% of the area of the void at base would be clear.
- Voids which extend below the base of the lens may have strudures with greater surface area, so long as those structures do not projed above the base.
- the length of the arms may also vary, depending on where and to what the arm attaches in the flat top region and whether the arm has a peripheral support.
- Arms that attach to a center support such as shown in Figure 1 A, may have a length from the shoulder to the center point of about 1.5 to about 4.5 mm, about 2.5 to about 4.5 or about 3 to about 4.5 mm.
- the length of the arm side sedion (when present) is determined by the height of the lens support, and may be from about 1.5 to about 4.5mm about 1.5 to about 3.5mm, or about 2 to about 3.5mm.
- the sides sedions may be perpendicular relative to the base, or may have any angle 103a ( Figure 1A) or curve that is less than the curvature of the lens, such that the desired contad area is not exceeded. Suitable angles indude up to about 15°, or between about 1° and about 10" outward from perpendicular.
- the angle 103b at the elbow transition between the side sedion and the peripheral support (when conneded to the arm) may be between about 60° and about 120°, or about 80° and about 100".
- the number and shape of the arms may also be varied, so long as they provide the desired balance of effident drainage of the lens solution upon opening, and contad area with the lens.
- the cases of the present invention may have one or more, three to eight, or three to six arms forming the central support, which may be designed to provide the desired contad area between the lens and finger, and resistance along the flat top against the finger touch, but only transitory contad with the contad lens at the optional side sedions and shoulder transitions.
- the shoulder transitions may be disposed radially around the center of the support. The shoulder transitions can be spaced at roughly equal angles from the center.
- the arms may be planar as is shown in Figure 1A, or curved, for example in a U-shape (not shown), or may be branched, for example in a straight or curved "Y" shape 101b, shown in Figure 1 B, a U-shape or a T- shape. Branching of the amn(s) may occur within the flat top region as shown in Figure 1 B, or at the peripheral support 105c, as shown in Figure 1 C.
- the support may have all planar arms, all branched arms or a mix of planar and branched arms, for example two branched arms and two straight arms as shown in Figure 1 C, three branched arms as shown in Figure 1 b, or all planar arms as shown in Figure 1 A.
- 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 branched arms (which may be straight or curved Y-shaped, U-shaped or T-shaped) arms and two planar arms and 2 branched arms (which may be straight or curved Y-shaped, U-shaped or T-shaped).
- the arm configurations may provide shoulder and peripheral support contact points which are disposed along arm planes (Figure 1A), or shoulder and peripheral support contact points which are offset from each other (Figure 1C).
- Each arm has a cross section sufficient to provide a lens support having resistance to prevent lens collapse during drainage, or excessive contact between the lens and lens support during lens transfer.
- the lens support is preferably formed from rigid materials, and the resistance of the arms may be controlled by the modulus of the lens support material selected and the dimensions of the arm.
- Rigid plastics which are suitable for injection molding small parts, such as polypropylene homopolymers and copolymers, cyclic olefin polymers (COPs), cyclic olefin copolymers (COCs), and mixtures thereof are suitable materials.
- polypropylene homo- and copolymers generally have flexural modulii in the range of 1100-1800MPa
- COPs and COCs have flexural modulii in the range of 1800-2900 MPa
- blends of polypropylene and COPs or COCs may have flexural modulii in the range of 1100-2900 MPa.
- the polypropylene may be nucleated, controlled rheology or both, and both Ziegler-Natta and metallocene catalyzed polypropylenes may be used.
- Polypropylene polymers may also include additives including processing aids such as glycerol monostearate, zinc stearates and calcium stearates, fillers which can modify the properties of polypropylene and the like.
- processing aids such as glycerol monostearate, zinc stearates and calcium stearates
- fillers which can modify the properties of polypropylene and the like.
- An example of a suitable polypropylene for use in lens cases in Boremed HF840 which is a polypropylene homopolymer with a slip agent, a melt flow index of 19g/10min and a flexural modulus of 1 ,250 MPa.
- the width of the arms can vary between the limits of the selected molding process and widths necessary for efficient lens solution drainage upon opening.
- Suitable arm widths include about 0.5 to about 1.5mm, about 0.5 to about 1, or about 0.5 to about 0.7 mm, and it will be appreciated that lens support designs having fewer contact points may have thicker arms.
- the height of the arms may vary from the limit of the injection molding process to the height of the arm from the base, in which case, the arm is a fin, as is shown in Figure 1 E and H, which may be attached to the base, be molded as a part of the base or may rest on the base.
- the arm When the arm is not a fin, it can have a height of 0.5 to about 1 ,5mm, about 0.5 to about 1 , or about 0.5 to about 0.7 mm. It will be appreciated that materials with lower modulii may benefit from arms that have a larger profile in either the height, width or both.
- Suitable materials for the lens support must also non-leaching, compatible with a variety of lens cleaning and care solutions, suitable for use with biomedical devices and inexpensive. Preferably the materials are also recyclable.
- the lens support materials can, but do not have to be, optically transparent.
- the lens support materials may be non-polar to encourage drainage of the lens solution. Non-polar materials are those that have a contact angle of greater than 90" via the sessile drop method using deionized water at 25°C.
- the lens support of the present invention can have a range of arm and peripheral support configurations and features and are not limited by the specific combinations shown in the Figures and discussed herein. Additional combinations of arm configurations will be apparent to those of skill in the art with reference to the teachings of the present application.
- the only limits on the design of the arms are the ability to mold the lens support, and the number and orientation of contact points to balance lens support with the desired drainage upon opening.
- the cases of the present invention may have additional features which with the lens support allow the lens solution to be drained from the lens and lens support.
- the additional drainage features provide a drainage path for lens solution.
- the drainage path creates, upon opening, an angled fluid film that forms between two solid members, such as adjacent peripheral supports, a generally vertical fluid film that forms between two solid members, such as a central column and a side section, or a steep or generally vertical path along a smooth solid surface, such as a side section or peripheral column wall.
- the shallower the angle of the drainage path the easier it is to break the flow path and encourage the formation of lens solution trapped between the lens and lens support, including reservoirs and residual films.
- Angled drainage paths having an angle between 10" and about 90" are suitable. Lens support and drainage features with sharp edges and very long routes can also break the drainage path.
- Integrally angled, elevated or elevated and angled lens supports may provide the desired drainage.
- Lens supports may also be disposed horizontally on the base and comprise a lifting structure, as described below.
- a drainage channel when present, cooperates with the lifting structure to create a temporary film of lens solution flowing off the lens, and a path, working with gravity to drain that film away. In this way the drainage channel helps to minimize pooling of lens solution between the back of the lens and lens support structures when the case is opened and the lens support is raised or tilted out of the lens solution.
- Drainage channels comprise at least one channel member which extends outward from the arc of the peripheral ring, at least partial peripheral ring or the arc formed by the distal ends of the non-elongated peripheral supports.
- the drainage channel comprises a gap between two adjacent members or a when a single member is used, a split in the single member.
- the drainage channel gap may begin at any point inside the lens periphery.
- the drainage channel gap may begin either at the inner edge of the peripheral ring, as shown in Figure 1C, or at any point inside the lens periphery.
- the drainage channel can extend at least 2 mm, about 2 to about 4mm or about 2.5 to about 3.5 mm in length beyond the peripheral ring or lens periphery if no peripheral ring is included.
- the drainage channel gap provides a space outside the periphery of the contact lens for airflow, ensuring that air and lens solution from the concave surface of the lens can, upon opening, drain without sucking the lens down onto the lens support.
- the portion of gap 111 which is inside the periphery of the lens, does not substantially participate in drainage.
- the upper limit for the length of the drainage channel is defined by the final size of the packaging and if included, the lifting structure.
- the drainage channel members 115 may be formed by extending adjacent peripheral support sections 105 beyond the arc of the at least partial peripheral ring 109 and joining the distal ends via a crosspiece 114 to form a gap or open channel 111 between the drainage channel members 115.
- the channel members 115 may be attached to and planar with the at least partial peripheral ring 109.
- drainage channel 113 may also be formed by extending ring support structures 105 from a point 112 inside the lens edge to a point beyond the arc of the at least partial peripheral ring and joined at the distal end by crosspiece 114.
- the drainage channel may also be formed by attaching the channel members 115 to the arms at any point, including, when the arms are fins, as shown in Figure 1 F, to the bottom of the fin.
- the drainage channel may also be formed by providing a gap in the peripheral ring with planar arms extending therefrom, such that the peripheral ring and drainage slot 113 form a keyhole shape, as is shown in Figure 1C.
- the peripheral ring/partial peripheral ring may connect to the elongated arms.
- the drainage channel members 115 may be straight as shown in Figures 1C-G, may be curved as shown in Figure 1 B, may flare out at the peripheral ring arc and taper in from the arc to the distal end or may be tapered from the at least partial peripheral ring to the distal end of the drainage channel. Any taper may be straight or curved.
- the drainage channel tapers toward the crosspiece 114.
- the drainage channel may be about 0.8 to about 3mm wide, and when tapered may be about 1mm or about 0.8 mm wide at the distal end or cross piece.
- drain channel configurations not illustrated or those that combine aspects of the exemplary configurations depicted are possible and 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.
- a drain channel may be omitted entirely.
- the drainage channel is not necessary, and the angle of the lens support provides the desired drainage upon opening the case.
- the case of the present invention may also comprise a lifting structure for lifting the lens support from the lens solution.
- the lifting structure may present the lens support and lens from the base and lens solution by any suitable means including tilting the lens support up, tilting the base down, raising the lens support up from the base, lowering the base down, or any combination thereof, and the like.
- the drainage channel in cooperation with other features of the case may function as the lifting member, or the lifting member may include structures such as springs, hinges, levers, pivot arms, folds, mechanical traps, handles and combinations thereof.
- the lifting member may comprise a rigid elongated member extending outward from a structure disposed along the bottom of the lens support, which may form part of the drainage channel.
- lens supports having elongated drainage channels 215, may include a flexible attachment 245 between the lens support 236 and lid 235 and is located opposite from the lid opening tab 228, such as is shown in Figure 2A.
- the flexible attachment can have any suitable structure, include a hinge, a flexible fold, pivot arm, mechanical trap and the like.
- the action of pulling up tab 228, and lid 235 opens the case and also lifts lens support 236 from the base 240, presenting the lens for removal by the user.
- the lifting member may also include an articulating or flexible strip or ring between the lid and lens support, or a folding arm connecting the base and lens support with a flexible attachment between the lid and lens support opposite the folding arm as shown in Figure 2B.
- lens presentation includes a lens member which pivots the lens up from the base and lens solution upon opening the lens case
- the lifting member pivots the lens support 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 level.
- Any means for attaching the lifting member to the lid, base or lens support may be used including, an adhesive, glue, any suitable weld, including, but not limited to heat, ultrasonic or laser welding, or a mechanical trap.
- the lifting member may also be molded as part of the lid.
- Additional lifting mechanisms include a simple loop, tab or handle could replace hinge 245 as the lifting mechanism. The user could open the lid and raise the lens support from the solution by lifting on the tab or handle.
- the lens support side sections may be deformable, replaced with a spring structure, or a spring 237 may be included under the peripheral supports or peripheral ring as shown in Figure 2C, such that in the closed position the lid engages with the lens support to compress the spring or support, without compressing the lens.
- the spring relaxes and lens support raises the lens above the lens solution.
- the peripheral supports, and central support top section would be made from rigid materials to limit lens to lens support contact and provide resistance during lens transfer.
- the spring may have any form, including flexible arms which may be straight or curved, a coil, and the like. The arms may interact with a lid feature around the peripheral ring of the lens support to compress the spring when the case is closed.
- peripheral supports should be designed not to detract from any drainage features included in the lens (including peripheral supports and rings).
- the lens solution may also be drained from the lens by removing at least one displacement member from the cavity of the lens case or by opening a separate seal near the bottom of the cavity, or may be poured from the cavity.
- the displacement member may be molded into the base or the lid structure, and when the case is closed, displaces lens solution in the base cavity, raising the solution level and submerging the lens support and lens.
- the displacement member 430 is molded into the base as shown in Figure 4A, the lens (concave or bowl up) and solution may be placed in the lid, and then the base is closed on top of the lid, and the case flipped so the lens edge rests on peripheral supports 405.
- the displacement member may also be in the form of a plug, as shown inf Figures 4B and 4C.
- the plug may have any configuration.
- Figure 4B shows a lens case of the present invention having a displacement member 430 in the form of a plug.
- the lens case has a two stage lid, shown by tabs 428a and 428b.
- tab 428b is raised exposing upper base chamber 440a containing lens solution cavity and the lens support.
- Lens solution is added to the lens solution cavity to the fill line and the lens is placed on lens support with the lens peripheral edge resting on peripheral supports 405.
- Solution preferably added first to allow good transfer from the finger to the lens support.
- the surface area between the finger and lens is greater than that between the lens and lens support. Partially or fully submerging the lens support prior to transferring the lens thereto aids in transfer back to the lens case.
- Tab 428b is closed forming a watertight seal with upper base chamber 440a.
- tab 428a is lifted raising the upper base chamber 440a which raises displacement member 434, exposing plug hole 431.
- Lens solution drains through plug hole 431 to a reservoir 419 in the form of a drainage chamber between the lens support and the bottom of the base. At this point lens 400 may be removed from the lens support by the wearer with a single touch.
- the bottom 419 of the base open to allow for solution removal and cleaning, via any convenient means such as a hinged base or door 439.
- the base itself may also be a displacement member such as when the lens and solution are loaded into the lid in the “upside down” configuration such as in Figure 4A or in configurations like the case in Figure 5C, which includes raised base section 548 under lens support 536 which is attached to sliding peripheral column 505 around the circumference of raised base section 548.
- lid 535 is screwed onto base 540 splines 549 inside lid 535 engage with ledges 551 on the outside of sliding peripheral column 505 to push sliding peripheral column 505 and lens support 536 below the lens solution.
- Air entry guide 527 includes flexible wedges 552 connecting a bowl 553, with the peripheral edge of air entry guide 527. As lid 535 is screwed onto base 540 flexible wedges 552 hold open vent 555 so it is the last thing to close and air can be vented from the chamber formed between bowl 553 and sliding column 505.
- the lens support may be disposed parallel to the bottom of the base as shown in Figures 2B and 2C or may be at an angle relative to the bottom of the lens base as shown in Figure 4B.
- the displacement member may take any form, induding a hollow cylinder which fits around the lens and lens support, a solid cylinder or plug.
- a fill line may also be induded in the base cavity to ensure the correct volume of solution is added by the lens wearer to fill the case cavity.
- the base may also comprise a reservoir 419 for capturing the lens solution when the lens is raised from the base.
- the reservoir may be anywhere in the base induding around the lens support, as shown in Figure 4A, under the lens support in a separate drainage chamber as shown in Figure 4B, or in a part of the base cavity, such as below and behind the lens support as shown in Figure 4C.
- the case of the present invention further comprises a lid.
- the contact lens sits in a molded plastic base, having a bowl to receive the contact lens in a concave, bowl up position.
- the cases of the present invention store the lens in a convex position and present the lens, free of lens solution, for one touch transfer to the finger of a wearer.
- the lid releasably seals to the case to form a watertight seal by any suitable means, including but not limited to a screw or snap closure.
- the lid may also be designed to control the flow of air into the case upon opening. It is desired that the contact lens remain on the lens support upon opening, instead of sticking to the lid. To achieve this air entering the case upon opening may be directed to travel over the top of the lens first. For cases with two or more lid sections, the topmost lid may be the last to close and the first to open
- the seal line of the cavity is at or near the highest point in the interior of the cavity.
- the seal line may be designed to ensure the lens is fully submerged upon dosing the lens case.
- air enters the cavity above the lens or the lid may have a space to channel entering air above the lens.
- the topmost tab 428b may be for loading the lens into the cavity, and the lower tab 428a opens the case to remove the lens.
- the air entry guides provide space for the air to travel above the lens, without getting trapped or diverted and may also cooperate with the lens support to prevent the lens from lifting or sliding off the support structure until some air has entered the case above the lens.
- the contact area between the air entry guides and the lens is preferably low, less than about 50 mm 2 or less than about 30 mm 2 .
- the air entry guides may be molded into the lid, either on the inside surface of the lid or as a projection from the lid or may be a separate structure disposed between the lens and the lid when the case is sealed.
- the air entry guides direct air entering the case along designed path over the top of the lens, ensuring the lens remains on the lens support in the desired convex orientation.
- the air entry guides are disposed along the direction the case lid travels upon opening the case.
- the air entry guides may have any orientation other than perpendicular to the path of desired airflow.
- the air entry guides are preferably disposed from the front of the case to the back and the intentionally designed path is over the lens from the case front to back.
- Suitable air entry guides may include prongs 321 projecting from the lid around the periphery of the lens as is shown in Figures 3A and 3B.
- the prongs maybe be rigidly mounted to a support ring or a molded plastic ring (Figure 3A) or may be flexibly mounted on a flexible sheet (Figure 3B), such as lidstock.
- the prongs may be radially disposed around the periphery of the contact lens, generally within 1 mm of the lens edge.
- the air entry guide can contain prongs around the entire periphery or primarily located along the front, sides or front and sides.
- the prongs may be adjacent to each other as is shown in Figure 3B or may be spaced apart as is shown in Figure 3A.
- the optical zone of the lens may be free of prongs to encourage air to travel over the top of the lens while the prongs keep the edges of the lens from sticking to the lid.
- the air entry guides may also be in the form of continuous or discontinuous (broken) ribs.
- the ribs can be attached to the inside surface of the molded lid (Figure 3C) or included via a separate molded structure ( Figure 3D).
- the ribs are aligned parallel to the path air enters upon case opening.
- the ribs may be spaced at least about 2 mm apart, about 2 to about 5 mm apart, or 2 to about 4.5 mm apart.
- the ribs may run in a straight line from front to back (Figures 3C and D) or may curve around the optic zone (Figure 3E) to prevent interaction between the ribs and the contact lens, which can cause optical distortions in high shape memory hydrogels.
- the ribs may run “edge to edge” across the inside lid surface, or their start or finish may be offset from the edge as shown in Figure 3G.
- the ribs may also extend away from the lens, forming recesses(s) 337 projecting up from the lid surface as shown in Figure 3H. Such recesses may act as an air entry guide during opening as well as an air capture space, described below.
- the ribs may have straight walls, may be wedge shaped as in 3G, may comprise an arc, or may have one straight wall and one angled or arc shaped wall.
- the angled or arc shaped wall may slope along the curvature of the contact lens.
- the rib height may be the same from the front of rib to the back (outer ribs in Figure 3B) or may be larger in the front than the back ( Figures 3C, 3F and 3G).
- the ribs may have a shorter profile over the optic zone, as shown by the central rib in Figure 3C and the wedges of Figure 3G or there may be a gap in the ribs (“broken ribs” 322b), as shown in Figure 3F.
- Air entry guides comprising a central rib with a stepped-down rib height across the optical zone are effective in directing the air in the desired direction, while also minimizing contact with the optical zone of the contact lens. As shown in the Figures different height profiles and shapes can be incorporated into a single air entry guide structure.
- the ribs may have a height of at least about 2 mm, which may extend from the interior of the lid toward the contact lens or may extend away from the contact lens and define a separate air entry channel. Rib heights may be at least about 2 mm at the highest points, such as those at 522 (the air entry guides outside the optic zone) and 0 to about 0.5 mm at the lowest points, such as those the back of the rib in Figures 3C and 3G or the midsection of the center rib in Figures 3D, E and F. In embodiments including ribs, below a peak rib height of 0.5 mm at least part of the rib the air bubble may not propagate across the entire top of the lens and the lens may stick to the bowl. Rib heights above about 4 mm may undesirably increase the size of the case and volume of packaging materials and lens solution needed.
- the maximum length of the stepped-down profile along the rib is about 8.5mm.
- the maximum length of the stepped down profile along the rib is about 9mm.
- adjacent ribs 322b may be curved outside the optic zone.
- the diameter of the curved rib region may be up to 11 mm or between about 7 to about 11 mm or about 8 to about 11 mm.
- the ribs When the ribs are part of a separate molded plastic frame, it may comprise cross supports on the back side of the ribs. However, the height of the ribs should ideally maintain at least about 2mm of clearance between the lens and cross supports to provide the desired airflow.
- cross supports Preferably when cross supports are used they are located on the back of the ribs and do not protrude or extend into the pathways defined by the air entry guides.
- the air entry guide structure is free of transverse structures, such as cross supports, or has less than 3, or 1 or no cross supports.
- the air entry guide may also comprise a full or partial ring around the air entry guides, shown as 327 a in Figure 3E and 327b in Figure 3B, respectively.
- such air entry guides may be attached to the lens support by a hinge (not shown) opposite the front of the air entry guide, to form a clamshell structure around the lens.
- the lid of the present invention may also cooperate with the lens support to maintain the lens centered around the support with minimal contact between the optical zone of the lens and the support and lid.
- the ribs may be designed so that any contact between the lens and the lid or lens support while the case is sealed is transitory.
- Cases which have a flip top may also have an air entry scoop 324, shown in Figures 3G and H and as 224 in Figure 2B.
- the air entry scoop is located at the designed point of opening, inside the retortable seal, which is the front of the case in Figure 3G.
- the scoop may be aligned with the opening tab, either directly as shown in Figures 3G and 3H, or may be offset, but aligned with opening tab 228 as shown in Figure 2B.
- scoop 324 projects out from the periphery of the contact lens edge at least about 1 mm or at least about 2mm, and is located within the seal. The length of the projection is limited only by the desired size of the case.
- the air entry scoop has a width between about 2mm and the inner diameter of the seal arc 325.
- the air entry scoop may be shallower than the lid and may slope into the lid cavity, as is shown in Figure 3G. Aside from the dimensions above the scoop may have any shape including but not limited to round, ovoid, triangular, square rectangular or irregular. Cases of the present invention may forego a separate air entry scoop such as by providing at least about 2mm clearance between the interior lid wall and lens support at the opening tab.
- Figure 3G is an inside view of a case lid and skirt region.
- the lid would be sealed to a film base along seal line 326.
- the air entry scoop 324 is at the front of the lid and comprises the front section of three broken air entry guide ribs 322a (which traverses the middle of, but has a shallow height within the optic zone) and 322b (which are curved around the optic zone of the lens).
- the case is opened by pulling up tab 328, which separates the lid from the base starting at the distal end of the air entry tab.
- the tab may have any form including a foil or plastic tab, grip, ring pull, handle or the like.
- the cases may also comprise a burp or air admittance valve to allow air to vent into the lens case and above the lens to maintain the lens on the lens support during opening of the case.
- the lens case cavity may contain a volume of solution that covers the lens, preferably in all storage orientations.
- the lens lid may also include one or more air outlet channels to allow air trapped in the case during closure to escape and minimize the amount of air in the closed lens case.
- the lids of the present invention may further comprise at least one air capture space away from the lens optic zone for air in the sealed case to occupy.
- the air capture spaces are designed such that the air remains in at least one air capture space away from the lens regardless of case orientation.
- the air capture space may have a volume equal to or slightly greater than the volume of air to be sealed in the case, and any air which may diffuse into the case during storage to insure all the air present at sealing, and any that might diffuse in during storage are retained away from the optical zone of the lens.
- the air capture space may be designed in a number of ways.
- the lid may further comprise a depression or dimple 329 above the center of the lens support to force any trapped air up around the periphery 330 of the dimple 329 and away from the lens apex, not shown.
- the depth of the dimple is selected so that the nadir of the dimple in the lid interior, or any air entry guide does not touch the apex of the lens when the case is sealed.
- the gap between the optical zone and any air entry guide or dimple is between about 0.25 and about 2 mm.
- Figure 4A is a drawing of the exterior of a case comprising a lid of the present invention.
- the dimple 430 is surrounded by an air capture channel 431.
- the depression formed by the dimple displaces any entrapped air into the air capture channels.
- the dimple may have a diameter of at least about the diameter of the optical zone of the lens.
- the combination of the dimple and the air capture channel holds the entrapped air in positions ranging from upright (base down), through 90". When the case is upside down, the air bubble is above the lens edge, and not a concern.
- the channel 431 may have the form of a ring as shown in Figure 4A or may have any other connected shape which provides sections which are higher than the center of the lid.
- the air capture space may have the form of a continuous channel around the inside seal edge, with sections above and below the apex of the lid, such as shown in Figure 4B, with 3 raised channel portions 431a.
- the dimensions of the air capture channel may be determined based upon the volume of air to be included in the case and the amount of air which will diffuse in during storage, which can be readily calculated.
- the channel may have any cross-sectional shape, including rounded edges, half round or half oval, rectangular or square. In some embodiments, the channel may have an interior width of about 1.5 to about 3 mm, or about 2 to about 3 mm.
- the air capture space may comprise at least two air pods protruding from the lid along the inner seal edge.
- the raised channel portions 431a in Figure 4B are examples of 3 air pods linked in a continuous channel.
- the air pods 331a may be linear or arcuate (as shown in Figure 3H), be parallel or transverse to the air entry direction, and may be separated by the dimple or connected by a connecting channel 337.
- the air capture space may comprise at least one, two, three or more air pods, with or without connecting channels. The air pods may be wider, taller or both wider and taller than the connecting channel.
- the air pods and connecting channel may have any cross-sectional shape that can be molded, including rounded edges, half round or half oval, rectangular or square.
- the connecting channel may have an interior width of about 1.5 to about 3 mm when it is desirable for the air bubble to pass between pods, or about 0.5 to about 2 mm in designs meant to prevent the air bubble from leaving the pod.
- Air captures channels and air pods can be included in a lid with or without dimples.
- the lens support and lid may be designed to cooperate when in the sealed orientation to keep the lens centered around the support structure without resting on the support structure or lid. This is more important for lenses that have longer shape memory, such as silicone hydrogel lenses, and the optics of the lens can be distorted by extended contact with any packaging feature or any air bubble trapped in the case. Contact between the support, lid and contact lens during storage and shipping may be acceptable with conventional hydrogel contact lenses, as they have shorter shape memory.
- the lens support may be designed in a number of configurations to provide the desired drainage and support so long as the primary functionalities of providing sufficient drainage and contact with the lens sufficient to insure consistent “one touch” lens transfer to the finger are met. It will be apparent to those skilled in the packaging art that the packaging features described herein may be used in a variety of combinations to achieve the desired one touch cases. For example, if lens solution is trapped between the lens and support, the efficiency of the drainage pathways may be increased, for example by increasing the open area beneath the lens support, decreasing the contact area between the lens and support, decreasing sharp edges and shallow drainage paths, adding a drainage channel, with or without a tilting or lifting means or a combination thereof. If the lens sticks to the lid upon opening, air entry guides and/or an air entry scoop may be added.
- Figures 2A, 4A-4C and 5A-F include examples of cases of the present invention having different combinations of features.
- the figures and descriptions are exemplary only and should not be considered to limit the case designs of the present invention.
- Figure 5A shows an exploded side view of a lens case comprising base 540, base collar 541 , lens support 536, air entry guide structure 533 and lid 535.
- the base and base collar can snap fit together, be glued or welded together or may be molded as one integral piece. When they are removably attached the base can be opened or removed and the lens, lens case cavity or both can be rinsed with fresh lens solution.
- Base collar is a cylinder which forms the cavity that houses the lens and lens support 536.
- the inside of the base collar may include a shelf 542 to receive the lens support.
- the shelf may support a portion of the lens support, such as peripheral ring 509 or a portion of the peripheral ring, or may be molded to follow the profile of the underside of the lens support, so long as the shelf shape and structure do not decrease the drainage performance.
- Lens support 536 rests inside base collar 541.
- the lens support peripheral ring 509 may be expanded, or a second ring may be added below the peripheral ring to provide better fit within the collar and mechanical durability. Any lens support described above may be used in the lens case of Figure 5A.
- the outer wall of the base collar comprises threads 543 which with threads 543 on the inside of lid 535, allow the case to be screwed closed to form a watertight seal.
- the walls of air entry guide ring 527 are displacement structures which when the case is closed, project into the base collar cavity and displace lens solution, ensuring the lens is fully submerged when the case is closed.
- the lens solution level drops below the peripheral ring, allow the lens solution to drain from the lens and lens support.
- the lens case of Figure 5A also includes an optional sliding seal formed by the inner wall of base collar 541 and the outer vertical wall of entry guide ring 527. As the lid is unscrewed from the base, the outer walls of air entry guide ring 527 slide upward with the lid, which allows air to enter the top of the collar cavity, over the lens, biasing the lens on the lens support.
- the lens 550 is maintained in the space formed between case lid 535 and lens support 536 (lens cavity).
- the lens cavity may be designed so that lens 550 (particularly in the optical zone) is not compressed during shipping, and only minimally contacts the interior features of the case and maintains integrity until the case is opened. Also, the lens cavity should not provide too large a gap between the lens and interior case features, so that the lens is held in the desired convex orientation relative to the case base during storage.
- Figure 5C shows another lens case of the present invention.
- the base 540 and lid 535 have a conventional lens case structure, but a lens support 536 and air entry guide ring 527 of the present invention.
- the lens support has 6 hollow arms surrounded by a vertical support 547 in the form of an peripheral column which keeps the lens support elevated from the interior of the base 540.
- the lid and base are sealed via threads 543.
- Figures 5 D and 5F the lens and solution are placed in the lid 535 on the air entry ribs 522 and the case is closed by snapping the base to the lid along a releasable seal 525.
- the lens support is connected to the lid by a lever 546
- the lens support has vertical supports 547 in the form of compressible spring arm sections.
- a contact lens 550 rests below lid 535, upon lens support 536.
- the lens support arm sections connecting the distal end of each peripheral support to the lens base. Not all peripheral supports may require a compressible arm for the lens support to function as described herein.
- Figures 5D and F disclose a lever and spring respectively, but the lifting structure may have a variety of configurations as detailed above.
- the lens case of Figure 5E is similar to Figure 5D, except that the base cavity houses a lens support 536 for both lenses instead of just one.
- the lens support 536 holds the lens in the desired convex position, with minimal contact area when the case is opened to insure efficient transfer of the lens to the finger of the user.
- Inner chamber 544 (designated in Figure 5C) is designed to hold the correct volume of lens solution to keep the lens fully submerged during storage and allow the lens, lens support 536 and lid 535 to work together properly.
- the case is opened by any convenient means, such as pulling tab 528 upward, which breaks seal 526 ( Figures 5D-5F) or unscrewing lid 535 from the base 540 or base collar 541 ( Figures 5A-C).
- Air is introduced into case in a controlled fashion and is guided into the case by air entry guides 522 so that the lens is biased away from case lid 535 and maintained on lens support 536. This gentle force acts in conjunction with the draining of solution from the lens 550 and lens support 536 so that the lens is generally maintained in a “ready to use” position on the lens support 536.
- the lid 535 is separated from the base, the lens solution drains from the lens and support.
- the lid 535 is raised pivoting lens support 536 up from the base via lever arm 546 to drain the lens solution from the lens 550 and lens support 536 and present the lens for transfer to the wearer’s finger.
- the central optical zone of lens 550 is generally clear of contact with the arms, other than at the peripheral supports 505.
- the flat top region 501 provide resistance to enhance the ability to transfer lens 550 to the finger with “one touch”.
- Lid 535 and reservoir 519 may be polypropylene or any other material which can be used for medical device packaging, and base 540 may be formed with plastic.
- the features of the case, induding the lens support, lid and the air entry guides, no matter how created, may be designed to interact with the lens outside the optical zone to prevent damage to lens optical zone.
- the wearer can remove lens 550 from the case with a single touch of a finger and adhere the convex side of the lens 550 to the finger.
- the apex of lens 550 is positioned on the finger and may be directly applied to the eye with its concave portion placed directly on the eyeball.
- the present invention provides cases which effectively channel lens solution away from the lens and lens support and control the ratio of the contact area between the finger and lens as compared to the area between the lens and the lens support, ensuring that surface tension between finger and lens exceeds surface tension between lens and lens support.
- the lens thus presented, consistently adheres to the finger, providing a “one touch” lens transfer experience to the wearer.
- the cases of the present invention may be manufactured using known materials and processes.
- the packaging materials may be virgin, recycled or a combination thereof.
- lens supports with central lens supports may be desirable for lenses with moduli less than about 25 psi, new wearers not used to one touch lens removal, or for wearers with a more forceful touch.
- Experienced wearers and those with a lighter touch may need cases with only peripheral supports.
- the cases of the present invention provide numerous opportunities to include ornamental designs and features, for example in the design of peripheral supports and ring, arms, fins, air management pods and channels, as well as overall case shape and profile.
- the contact lens cases of the present invention incorporate several novel functionalities which may be combined in a wide variety of combinations as described herein to provide the desired one touch packaging, including the following.
- Preventing the lens from rotating off the support which may be accomplished by Including a minimum of 3 points of contact on the periphery of the lens, which may be arranged in an acute triangle.
- Preventing the lens translating horizontally across the support which may be accomplished by a horizontal or near horizontal contact near the periphery of the lens, where the lens surface is more steeply angled (located outside a central region having a diameter of at least about 5 mm, about 6 mm, or about 7 mm, or the contacts can be just outside the periphery of the lens.
- the height of the structure is no lower than the base of the lens.
- the support structure may also be less than 2 mm below lens apex.
- the shape of the surface may be flat or slightly concave (e.g. down to a radius of curvature of about 10 mm), but may less preferably be slightly convex (down to a radius of curvature of about 10 mm) or more concave (e.g. down to a radius of curvature of about 6 mm).
- the diameter of the surface should be about 1-10 mm, preferably 6-9 mm (to match fingertip size).
- the surface does not need to be continuous - it may be made up of a series of point or lines.
- the optical zone is free floating and contact with the lens support during storage is transitory or non-existent. This can be achieved by making any central supports slightly lower than the profile of the lens (so that the lens only contacts the support at the periphery).
- Buffered solution 1000 g Dl water, 13.55 gm NaCI, 27 gm boric add, 5 gm sodium borate, 0.3 gm EDTA, and having a pH of about 7.4.
- Packaging solution RevitaLens Complete (Alexidine 0.00016%; Polyquatemium-1 0.0003% (PQ-1); EDTA.
- Polypropylene isotactic polypropylene homopolymer, having an MFR of 24 g/10 min, (Lumicene M3766) from Total
- Lidstock multilayer film comprising layers of oriented polypropylene (12 pm), aluminum foil (50 pm) and polyester film (12 pm).
- lens support architectures were evaluated to determine support features which can provide desirable lens support, lens solution drainage and lens transfer.
- Each of the evaluated lens supports was 3D printed on a Form 2, using Formlabs Formlabs clear resin.
- the lens supports were printed with a drainage channel terminating in a 90° lever to allow the support and lens to be lowered and raised from a packaging solution chamber having dimensions 30mm x 45mm x 25mm.
- a 1-Day ACUVUE MOIST contact lens was removed from its package and placed on each lens support while the support is submerged in packaging solution to allow for full wetting, and mounting the lens centered on the support.
- the lens support and lens were submerged in the packaging solution chamber for at least 5 seconds, to insure is fully submerged with no air bubbles remained under the lens.
- the packaging solution was withdrawn to expose the peripheral support.
- the support was then slowly pivoted from the remaining packaging solution using the lever and allowed to drain until the solution appeared to have drained from the lens and support or after about 10 seconds, which ever was sooner.
- the lens was evaluated for permanent fluid films, solution reservoirs and internal bridges between the lens and support. Photographs were taken and evaluated for lens centration, areas of fluid trapped between the lens support arms and the lens and lens deformation.
- a rubber nitrile glove was worn on the hand used for dab testing. The test was repeated at least 5 times for each support design, changing out the lens after 2 repeats.
- Table 1 The results are shown in Table 1, along with a representative photograph, and a CAD drawing showing the lens support configuration.
- films of packaging solution may form between lens edge and peripheral ring. Films formed at beginning of drainage are good, and for lens supports with good drainage, the films break before drainage is completed. Residual films remaining once drainage has stabilized can interfere with lens transfer. Films noted in the tables are residual films that remained once drainage had stabilized.
- the peripheral ring can also reduce lens wrapping, due to the surface tension of the films formed around the periphery of the lens.
- Example 1 showed less lens wrapping than Example 2 (no ring).
- Example 5 is the same lens support as Example 3, but with a peripheral ring added around the peripheral supports. Both Example 5 and 3 showed excellent drainage speed (moderate-fast and fast respectively) and excellent drainage efficiency evidenced by no permanent fluid films, small solution reservoirs and only light internal fluid bridges.
- Example 6 is the same lens support design as Example 2, but the arms are solid fins which connect to the peripheral supports. The filling in the arm structures slowed the drainage speed, but the drainage efficiency was the same as Example 2, confirming that lens supports of the present invention with open arms or solid fins can provide good drainage and consistent lens transfer. The comparison between Example 2 and Example 6 also shows that drainage speed may be decreased by removing structures below the lens support (such as solid fins).
- the lens support of Comparative Example 2 has a similar structure to Example 1 , but with curved side sections, which formed severe internal fluid bridges which caused the lenses to stick to the lens support, creating undesirably high lens to support contact area. The increased contact resulted in a 0% transfer rate upon finger dabbing.
- the lens support of Comparative Example 3 had a fully curved lens support, with a smaller radius than the lens support of Comparative Example 2, but still evidenced undesirable solution reservoirs and interal fluid bridges. Comparative Example 3 also had a fully curved top section, which provided insufficient contact area between the lens and finger upon dabbing (0% first time dabbing success).
- Examples 9, 10 and Comparative Example 6 displayed significant lens movement during opening, which could be improved by providing one or more positioning guide along the top of one or more of the peripheral supports.
- Examples 9 and 10 show that lens supports with only peripheral supports and no central column can provide good drainage and lens transfer.
- Example 10 had an 8 mm gap between opposite peripheral supports, with one side of the drainage channel extending to the center of the support.
- the lens support of Comparative Example 6 is similar to that of Example 10, but without a peripheral support arm extending under the center of the lens. The lack of a structure in the center of the lens, caused the lenses to collapse in the center during drainage or upon attempted lens transfer, and also provided insufficient resistance during lens transfer.
- the ACUVUE Moist lenses used have a very low modulus, and lenses with higher moduli, such as silicone hydrogels, will not collapse as readily. As is shown by Examples 9 and 10, extending at least one peripheral support arm under the lens center decreases the collapse of the lens in the center, and provides good lens transfer.
- a flat dome can be designed with sufficient surface area to suck the lens to the dome to prevent the lens moving (Comparative Example 10) but it also prevents dabbing.
- Example 7 was repeated varying the diameter of the peripheral ring as shown in Table 5.
- the support having a peripheral ring of 16 mm trapped solution between the lens and support.
- the supports with 18 and 25 mm peripheral rings both provided good drainage with few reservoirs of trapped packaging solution. While the 16 mm diameter used in the support for Example 14 was too small for a lens with a diameter of 14.2 mm, it would be acceptable for a lens with a smaller diameter.
- lens support architectures were evaluated to determine support features which can provide desirable lens support, lens solution drainage and lens transfer.
- Each of the evaluated lens supports was 3D printed on a Form 2, using Formlabs Formlabs white resin.
- the lens supports were printed with “L” shaped grips 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 30mm x 45mm x 25mm.
- a 1-Day ACUVUE MOIST contact lens was removed from its package and placed on each lens support while the support is submerged in packaging solution to allow for full wetting, and mounting the lens centered on the support.
- the lens support and lens were submerged in the packaging solution chamber for at least 5 seconds, to insure is fully submerged with no air bubbles remained under the lens.
- the lens holder was slowly lifted out of the chamber and set on a support of a similar size to the solution chamber, but with only two sides to support the grips.
- the lens holder was allowed to drain for about 10 seconds (until the drainage stopped changing) before evaluating the drainage and lens transfer. Photographs were taken and evaluated for lens centration, areas of fluid trapped between the lens support arms and the lens and lens deformation. To ensure a consistent dab surface and simulate a low adhesion finger, a rubber nitrile glove was worn on the hand used for dab testing. The test was repeated at least 5 times for each support design, changing out the lens after 2 repeats.
- Example 15 formed fluid films between the periphery of the lens and the lower peripheral ring and drained well. Comparative Example 10 and Comparative Example 9 did not form vertical films and both drained poorly despite having very similar geometry to Example 15.
- Horizontal films are not sufficient for drainage. Films are formed between the lens and the outer ring in Comparative Example 8, however the lens still didn’t drain. Horizontal films also tend to be much more difficult to break, and hence impede lens removal.
- the present invention includes the following embodiments/elements/features in any order and in any combination.
- a contact lens case comprising a support for maintaining a contact lens in a convex position on the support during storage and upon opening the case; wherein the lens has a peripheral edge and a lens profile; the support has a profile that does not substantially match the lens profile; and wetted contact between the support and the lens is less than about 20 mm 2 , less than 18mm 2 or less than 15 mm 2 .
- a contact lens case comprising a case base; a case lid; and a support for holding, in a convex position relative to the case base, a contact lens having a peripheral edge and a lens profile; wherein the base and lid are sealed to form a cavity comprising the support, contact lens and packaging solution; wherein the lens support comprises a plurality of peripheral supports which have a distal end extending at least 1 mm beyond the contact lens peripheral edge and provide at least 3, 3 to 14, 4 to 14, 3 to 8 or 4 to 8, 4 to 6 or 6 points of contact with the contact lens edge along the peripheral supports and wetted contact between the support and the lens after the case has been opened and the packaging solution has been directed away from the lens and support, is less than about 20 mm 2 , less than 18mm 2 or less than 15 mm 2 .
- the contact lens case of claim 9 wherein the central lens support further comprises a diameter of about 1 to about 10 mm, about 3 mm to about 9mm, about 5 mm to about 9mm, or about 6mm to about 9mm.
- 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.
- claims 2 to 17 further comprising at least a partial ring around the distal ends of the peripheral supports, at least 2mm beyond the contact lens peripheral edge.
- each of the arms and peripheral supports have a width of about 0.5 to about 1.5mm, about 0.5 mm to about 1 mm, or about 0.5 mm to about 0.7 mm.
- each arm has a height at the flat top section of about 0.5 to about 5 mm.
- angle between the side section and the peripheral support is between about 60° and about 120°, or about 80° and about 100°.
- peripheral supports are parallel to the case base, and at least about 4 mm or at least about 5mm from said case base.
- lifting means is selected from levers, springs, hinges, pivot arms, folds, mechanical traps, handles and combinations thereof.
- a contact lens case comprising a support for holding, in a convex position relative to the support, a contact lens having a convex surface; and a lens facing surface comprising at least one air entry guide configured such that, upon opening the case by a user, the at least one air entry guide guides air entering the case over the contact lens convex surface to reduce the incidence of the convex lens surface sticking to the lens facing surface.
- the contact lens case of claim 48 wherein the case interior defines a cavity comprising the support, at least one air entry guide, contact lens and packaging solution; and upon opening the case and draining the packaging solution from the lens and the but prior to contact by a user’s finger the lens maintains a convex shape on the lens support, and the support contacts the lens in at least two points distributed around the lens periphery.
- the case of claims 1 and 48 further comprising at least one base section and at least one lid facing surface which together form a reversibly sealed cavity comprising within the cavity the support, contact lens and lens solution.
- said lid facing surface is an interior surface of a case lid; and the case further comprises at least one base section, which with the lid forms the cavity containing the lens support, lens and packaging solution; the case further comprising at least one opening tab for initiating the separation of the lid from the base along a seal line forming the cavity.
- claims 48-61 and 63-67 further comprising an air capture space away from the lens optic zone for air in the cavity to occupy.
Landscapes
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- Eyeglasses (AREA)
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- Switches Operated By Changes In Physical Conditions (AREA)
Abstract
Description
Claims
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US202063077784P | 2020-09-14 | 2020-09-14 | |
PCT/IB2021/058380 WO2022054033A2 (en) | 2020-09-14 | 2021-09-14 | Single touch contact lens case |
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EP4210537A2 true EP4210537A2 (en) | 2023-07-19 |
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EP (1) | EP4210537A2 (en) |
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-
2021
- 2021-09-13 TW TW110133980A patent/TW202231215A/en unknown
- 2021-09-14 AU AU2021340013A patent/AU2021340013A1/en active Pending
- 2021-09-14 WO PCT/IB2021/058380 patent/WO2022054033A2/en active Application Filing
- 2021-09-14 KR KR1020227042298A patent/KR20230066511A/en unknown
- 2021-09-14 US US18/008,940 patent/US20230354974A1/en active Pending
- 2021-09-14 CA CA3183629A patent/CA3183629A1/en active Pending
- 2021-09-14 EP EP21783353.2A patent/EP4210537A2/en active Pending
- 2021-09-14 JP JP2022575391A patent/JP2023541089A/en active Pending
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WO2022054033A2 (en) | 2022-03-17 |
KR20230066511A (en) | 2023-05-16 |
CA3183629A1 (en) | 2022-03-17 |
WO2022054033A3 (en) | 2022-04-21 |
AU2021340013A1 (en) | 2023-01-19 |
JP2023541089A (en) | 2023-09-28 |
US20230354974A1 (en) | 2023-11-09 |
TW202231215A (en) | 2022-08-16 |
CN115768304A (en) | 2023-03-07 |
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