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Title:
CONTACT LENS PACKAGES AND LENS SUPPORTS FOR USE THEREIN
Document Type and Number:
WIPO Patent Application WO/2023/248062
Kind Code:
A1
Abstract:
The present invention relates to improved contact lens packages and lens supports for use therein. A contact lens package may have a lid, a base having a cavity that houses a contact lens and packaging solution and a lever. A lens support configured lift the contact lens out of the packaging solution in a position on the lens support capable of single-touch transfer by a user. The package may include a locking mechanism configured to lock the lever in place when the lens support is lifted to a predetermined lift angle.

Inventors:
POPWELL SAM JONATHAN (US)
ANSELL SCOTT F (US)
WARD DANIEL GRAHAM (GB)
SAMS STEPHEN (GB)
SHORE BRETT (US)
AKRAM ISMAIL (GB)
Application Number:
PCT/IB2023/056138
Publication Date:
December 28, 2023
Filing Date:
June 14, 2023
Export Citation:
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Assignee:
JOHNSON & JOHNSON VISION CARE (US)
International Classes:
A45C11/00
Domestic Patent References:
WO2022054031A22022-03-17
Foreign References:
DE4415003C11995-06-29
Attorney, Agent or Firm:
LANE, David A. et al. (US)
Download PDF:
Claims:
WHAT IS CLAIMED IS:

1. A contact lens package comprising: a lid; a base comprising: a cavity that houses a contact lens and packaging solution; and a lever; and a lens support coupled to the lever and configured to lift the contact lens out of the packaging solution in a position on the lens support capable of single-touch transfer by a user.

2. The contact lens package of claim 1, wherein at least one of the lever and the lens support is a discrete component that is coupled to the base by an attachment means.

3. The contact lens package of claim 1, wherein a pivot line is defined by at least one void in the base.

4. The contact lens package of claim 1, wherein a pivot line is imparted into the base by one or more of: a crease, a cut, a thinned line, and an etch.

5. The contact lens package of claim 1, wherein the base is composed of a relatively rigid material.

6. The contact lens package of claim 5, wherein the lid comprises a film and the base comprises a plastic material.

7. The contact lens package of claim 1, wherein the base and the lens support are a single unitary component.

8. The contact lens package of claim 1, wherein the lever and the lens support are a single unitary component.

9. The contact lens package of claim 1, wherein the lens support is coupled to the base by at least one of: i) a laser weld; ii) heat; iii) an ultrasonic weld; and iv) an adhesive.

10. The contact lens package of claim 1, wherein the base comprises at least one finger engagement feature configured to i) aid a user in grasping the package or i) direct the application of force such that the lever hinges downward.

11. The contact lens package of claim 10, wherein the at least one finger engagement feature comprises a dimple sized to accommodate a finger or thumb of the user, wherein the dimple is positioned at an end of the base proximal to the user.

12. The contact lens package of claim 1 further comprising a locking mechanism configured to lock the lever in place when the lens support is lifted to a predetermined lift angle.

13. The contact lens package of claim 12, wherein the locking mechanism comprises at least one of a latch, ratchet, peg, and an adhesive.

14. The contact lens package of claim 12, wherein the predetermined lift angle is at least about 45 degrees.

15. The contact lens package of claim 1, wherein the lens support is configured such that the contact lens's upper side emerges from the packaging solution before the contact lens's lower side when lifted.

16. The contact lens package of claim 15, wherein the lens support has an emergence angle of at least zero degrees or at least 5 degrees.

17. The contact lens package of claim 15, wherein the lens support has a primary lens angle of between -4 degrees and 20 degrees and a lever length between about 11mm and 16mm.

18. The contact lens package of claim 1, wherein the lid comprises at least one lens facing surface that extends downward into the cavity above the contact lens when the package is in an unopened state.

19. The contact lens package of claim 18, wherein the at least one lens facing surface and lens support are configured within the cavity such that the optical zone of the contact lens resides in the packaging solution between the lens facing surface and lens support when the package is in an unopened state.

20. The contact lens package of claim 1, further comprising a secondary support configured to support to the lens only when the package is unopened.

21. The contact lens package of claim 20, wherein the secondary support comprises at least one recessed area in a shape and position that allows the lens support to nest together with the secondary support to form a dome shape that mirrors the concave side of the lens when the package is in an unopened state.

22. The contact lens package of any of claims 1-21, wherein the cavity houses the contact lens in a convex position when the package is in an unopened or opened state.

23. The contact lens package of any of claims 1-21, wherein when the package is an opened state the wetted contact area between the lens support and the contact lens is less than about 30mm2, less than about 25mm2, or less than about 20mm2.

24. The contact lens package of claim 1, comprising at least one lens facing surface in the cavity above a convex side of the contact lens, wherein when the package is in an unopened state the at least one lens facing surface is configured to align the contact lens over the lens support; or protect the contact lens against significant optical damage due to gravitational, mechanical, or air-induced forces.

25. The contact lens package of claim 24, wherein the at least one lens facing surface is provided on a lid insert, wherein the lid insert is attached to an inner surface of the lid.

26. The contact lens package of claim 25, wherein the lid insert includes at least one alignment feature.

27. The contact lens package of claim 25, wherein the lid insert includes at least one lock-out feature.

28. A contact lens package comprising a contact lens in packaging solution, a lens support, and a locking mechanism wherein the lens support is configured to lift the contact lens out of the packaging solution and the locking mechanism is configured to lock at a predetermined lift angle the lens support having the contact lens thereupon.

29. The contact lens package of claim 28, wherein the package comprises a lever configured to cause the lens support to lift the contact lens out of the packaging solution when a user applies force to the lever.

30. The contact lens package of claim 29, wherein the package is configured such that the force being applied to the lever causes the lens support to lift the contact lens out of the packaging solution in a position on the lens support capable of single-touch transfer by the user.

31. The contact lens package of claim 29, wherein at least one of the lever and the lens support is a discrete component that is coupled to the base by an attachment means.

32. The contact lens package of claim 29, wherein the base is composed of a relatively rigid material.

33. The contact lens package of claim28, wherein the base and at least one of the lever and the lens support are a single unitary component.

34. The contact lens package of claim 29, wherein the lever and the lens support are a single unitary component.

35. The contact lens package of claim 29, wherein the lens support is coupled to the base by at least one of: i) a laser weld; ii) heat; iii) an ultrasonic weld; iv)mechanical clipping; and v) an adhesive.

36. The contact lens package of claim 29, wherein the base comprises at least one finger engagement feature configured to i) aid a user in grasping the package or i) direct the application of force such that the lever hinges downward.

37. The contact lens package of claim 28 further comprising at least one finger engagement feature having a dimple sized to accommodate a finger or thumb of the user, wherein the dimple is positioned at an end of the base proximal to the user.

38. The contact lens package of claim 28, wherein the locking mechanism comprises at least one of a latch, ratchet, peg, and an adhesive.

39. The contact lens package of claim 28, wherein the predetermined lift angle is at least about 45 degrees.

40. The contact lens package of claim 28, wherein the lens support is configured such that the contact lens's upper side emerges from the packaging solution before the contact lens's lower side when lifted.

41. The contact lens package of claim 28, wherein the lens support has an emergence angle of at least zero degrees or at least 5 degrees.

42. The contact lens package of claim 28, wherein the lens support has a primary lens angle of between -4 degrees and 20 degrees and a lever length between about 11mm and 16mm.

43. The contact lens package of claim 29, wherein a lid of the package comprises a lens facing surface that extends downward into the cavity above the contact lens when the package is in an unopened state.

44. The contact lens package of claim 43, wherein the lens facing surface and lens support are configured such that the optical zone of the contact lens resides in the packaging solution between the lens facing surface and lens support when the package is in an unopened state.

45 The contact lens package of claim 28, further comprising a secondary support configured to support to the lens only when the package is unopened.

46. The contact lens package of claim 45, wherein the secondary support comprises at least one recessed area in a shape and position that allows the lens support to nest together with the secondary support to form a dome shape that mirrors the concave side of the lens when the package is in an unopened state.

47. The contact lens package of any of claims 28-45, wherein the package houses the contact lens in a convex position when the package is in an unopened or opened state.

48. The contact lens package of any of claims 28-45, wherein when the package is in an opened state, wetted contact area between the lens support and the contact lens is less than about 30mm2, less than about 25mm2, or less than about 20mm2.

49. The contact lens package of claim 28, comprising at least one lens facing surface in the cavity above a convex side of the contact lens, wherein when the package is in an unopened state the at least one lens facing surface is configured to align the contact lens over the lens support; or protect the contact lens against significant optical damage due to gravitational, mechanical, or air-induced forces.

50. The contact lens package of claim 28 further comprising a lid insert.

51. The contact lens package of claim 50, wherein the lid insert includes at least one alignment feature.

52. The contact lens package of claim 50, wherein the lid insert includes at least one lock-out feature.

53. A lens support for lifting a contact lens out of packaging solution in a contact lens package wherein the lens support holds the lens in a convex position and the lens support is configured such that the contact lens's upper side emerges from the packaging solution before the contact lens's lower side when lifted.

54. The lens support of claim 53, wherein the lens support has an emergence angle of at least zero degrees or at least 5 degrees.

55. The contact lens package of claim 53, wherein the lens support has a primary lens angle of between -4 degrees and 20 degrees and a lever length between about 11mm and 16mm.

56. The contact lens package of claim 53, wherein the lens support is configured to produce a wetted contact area between the lens support and the contact lens of less than about 30mm2, less than about 25mm2, or less than about 20mm2.

Description:
CONTACT LENS PACKAGES AND LENS SUPPORTS FOR USE THEREIN

I. BACKGROUND OF THE INVENTION

In a conventional contact lens package, the contact lens typically sits in a molded plastic base having a cavity (or "bowl") that houses the contact lens in a concave-side- up orientation. As a result, the user experience for transferring a contact lens from the package to an eye generally involves the user "fishing" the contact lens out of the bowl with a finger and then flipping the lens so that it is in the correct orientation on the finger for placement on the eye. This process requires touching the lens multiple times, which can transfer contaminants or pathogens from the hand to the lens and ultimately to the eye. Not only is this handling experience unsanitary, but it is also unduly cumbersome, messy, and mechanically stressful to the lens, which can tear, rip, or distort when overly manipulated. While some packages have been designed to present the lens in a convex- side-up orientation to obviate the need for flipping the lens, they often still require the lens to be "fished" from the packaging solution or otherwise necessitate manipulation of the lens and/or multiple touches of the lens to achieve transfer of the lens to the eye.

In view of the growing awareness around ocular health and the customer demand for a more convenient experience, a need has arisen for contact lens packaging that enables a less messy and more sanitary contact lens handling process. In one respect, it would be ideal to provide wearers of contact lenses with a "single touch" package— that is, a package whereby the wearer of contact lenses can take the lens from the lens storage package with a single touch of one of a finger, and then, with this single touch, position the lens correctly on the eye. In such a design, there would be no need for transfer and manipulation of the lens from one finger to another before placing the lens on the eye. Providing such a single touch package would not only streamline the lens preparation and insertion process; it would also diminish the possibility of dropping the lens or exposing the lens to additional bacteria on a wearer's other fingers as the lens is being prepared for orientation and insertion onto the eye, and it also reduces the possibility of touching the side of the lens which is intended to contact the eye.

Design of a single touch lens package faces some distinct challenges. The wearer ideally should be able to consistently position the lens to adhere to the finger during removal from the package, and then the lens needs to consistently release from the finger onto the eye. Contact lenses (of both the reusable and daily disposable variety) each has its own unique surface, bulk, and geometric properties. Finger size and the force a contact lens wearer imparts on the lens during transfer can also vary. These factors can impact the process for taking the lens from the package onto the finger and then onto the surface of the eye. Among other considerations: it would be desirable for wearers to be able to drain away any packaging solution which might impact the ability of adhering the lens to the finger, as variation in the amount of packaging solution adhering to the lens and package can impact the process of placing the lens on the finger. It would also be desirable for package solution to drain away in a controlled fashion that avoids spillage. It would also be beneficial for the packaging solution to remain sterile and accessible to the wearer after opening to permit re-wetting or cleansing of the lens. Also, the wearer may be concerned about the potential of transferring bacteria or external products such as make up to the contact lens; and of course, manufacture of the package itself should conform to expected industry standards recognized by the medical and commercial provider communities.

Further, the single touch package ideally should not result in an inordinate increase in the cost of goods over current contact lens packages, as this could result in increased costs to the wearer community. The package should not make it difficult to hold the lens when removed from the package. Additionally, if the configuration of the package were to maintain, or even reduce the volume of solution needed to package the lens, this would reduce the ecological impact of the lens package. Similarly, it would be beneficial if all or part of the package could be made of recycled materials, and/or recyclable in whole or part.

In addition, it would be advantageous if the package were composed of materials that are already approved by the various regulatory bodies and ideally did not require a change in solution chemistry or lens composition. Optimally, as well, the functionality of the package preferably does not incorporate any electronics or other electrical components if such components could adversely affect performance of either the package or the lens.

There are several desirable attributes that have made achieving the function of a single touch package challenging and that are often lacking in known attempts to create a single touch package. These attributes include, for example, the following: i) the package ideally should protect the lens, i.e., it should ensure the lens's integrity (e.g., lens shape and optical integrity), while at the same time prevent crushing or damage to the lens; ii) the lens package should maintain the hydration of the lens when stored to maintain the lens's properties; and iii) the lens in its package preferably should be configured so that when desired, it is fully submerged in the packaging solution, yet be cleared of such solution when ready to be transferred from the packaging; iv) the package generally should have a retortable seal and contain both the lens and solution; v) the package preferably should maintain the lens in the desired convex orientation to the wearer; vi) the lens should be positioned so that it can be easily removed by the wearer; and vii) the package ideally should allow the packaging solution to be effectively drained away from the lens upon opening of the packaging and prior to lens removal to enable easier transferred to the wearer's finger and then onto the eye.

Known packages that have sought to provide reduced-touch or single-touch orientations fail to provide one or more of the above-noted desired attributes for a single-touch package. For example, WO2014/195588, W02009/069265, and JP6339322 disclose packages that present the lens in a convex, bowl down configuration. Similarly, US20200229560 discloses packages with lens supports that support the concave (anterior or front) surface of the contact lens, or grates that support the contact lens peripheral edge and allows packaging solution to drain through a grate to a bottom chamber upon opening the lens package. However, these package designs produce excess wetted contact area between the lens and lens support. Likewise, U.S. Patent No. 7,540,376, discloses lens carriers having rigid members under the apex of the contact lens, which impede the ability of the user to dab the lens. Known packages thus may not support the desired, convenient user experience, for example they may not support consistent single-touch transfer of the lens. The foregoing noted deficiencies of the prior art are merely exemplary and not exhaustive.

Thus, there remains a need for contact lens packages which provide a consistent single-touch lens removal experience, effective solution management, or addresses one or a combination of the aforementioned challenges or deficiencies.

II. SUMMARY

It has now been found that some or all the foregoing and related objects may be attained in a contact lens package having one or more aspects described herein. III. BRIEF DESCRIPTION OF THE DRAWINGS

The foregoing and other features and advantages of the invention will be apparent from the following, more particular description of preferred embodiments of the invention, as illustrated in the accompanying drawings.

FIG. 1A illustrates an exemplary contact lens package according to an embodiment of the present invention.

FIGS. 1B-D illustrate steps of opening a contact lens package according to an exemplary embodiment of the present invention.

FIG. 2 illustrates a perspective view of a contact lens package in an opened state according to an embodiment.

FIG. 3 illustrates an exploded perspective view of a contact lens package according to an embodiment.

FIGS. 4A and 4B illustrate a close-up view of a lid insert of an embodiment.

FIG. 5 illustrates a cross-sectional view of a contact lens package in an unopened state according to an embodiment.

FIG. 6 illustrates a cross-sectional view of a contact lens package in an opened state according to an embodiment.

FIGS. 7A and 7B illustrate a base of a contact lens package with a locking mechanism in an unlocked and locked state respectively an according to an embodiment.

FIGS. 8A and 8B illustrate a lens support of an embodiment in a top and side view, respectively.

FIG. 9 illustrates a method of measuring the wetted contact area of a lens support. IV. DETAILED DESCRIPTION

Reference will now be made in detail to representative embodiments illustrated in the accompanying drawings wherein reference numerals indicate certain elements. The following descriptions are not intended to limit the myriad embodiments to one preferred embodiment. To the contrary, it is intended to cover alternatives, modifications, and equivalents as can be included within the spirit and scope of the described embodiments as defined by the appended claims.

References to "one embodiment," "an embodiment," "some embodiments," "an example embodiment," etc., indicate that the embodiment described may include a particular feature, structure, aspect, or characteristic, but every embodiment may not necessarily include the particular feature, structure, or characteristic. Moreover, such phrases are not necessarily referring to the same embodiment. Further, when a particular feature, structure, aspect, or characteristic is described in connection with an embodiment, it is submitted that it is within the knowledge of one skilled in the art to effect such feature, structure, or characteristic in connection with other embodiments whether or not explicitly described.

As used herein, the following terms have the following meaning. A benefit of the certain embodiments the present invention is that they facilitate consistent single-touch lens transfer from the package to a wearer's finger, and then from the finger to the wearer's eye without the lens inverting, falling off the finger or further manipulation. Consistent single-touch lens transfer includes a transfer rate of at least about 70%, at least about 80% or at least about 90% transfer on the first touch of the finger (or "dab"). The lens also desirably "sits up" on the finger without collapsing or inverting and then transfers to the eye when placed there. Packages of certain embodiments may provide the desired single-touch lens transfer across a range of finger sizes, and dab pressures. Environmental conditions such as the temperature and whether the finger is wet or dry may also impact transfer rate, with higher temperatures generally improving lens transfer.

Lens(es) or contact lens(es) refer to ophthalmic devices that reside on the eye. They have a generally hemispheric shape and can provide optical correction, cosmetic enhancement, UV blocking and visible light or glare reduction, therapeutic effect, including wound healing, delivery of drugs or neutraceuticals, diagnostic evaluation or monitoring, or any combination thereof. The term lens includes soft hydrogel contact lenses, which are generally provided to the consumer in a package in the hydrated state, and have a relatively low moduli, which allows them to conform to the cornea. Contact lenses suitable for use with the packages of the present invention include all hydrated contact lenses, including conventional and silicone hydrogel contact lenses.

A hydrogel is a hydrated crosslinked polymeric system that contains water in an equilibrium state, and may contain at least about 25%, or at least 35% water in the hydrated state. Hydrogels typically are oxygen permeable and biocompatible, making them excellent materials for producing contact lenses.

Conventional hydrogel contact lenses do not contain silicone containing components, and generally have higher water content, lower oxygen permeability, moduli, and shape memories than silicone hydrogels. Conventional hydrogels are prepared from monomeric mixtures predominantly containing hydrophilic monomers, such as 2-hydroxyethyl methacrylate ("HEMA"), N-vinyl pyrrolidone ("NVP") or polyvinyl alcohols. 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%. Examples of silicone hydrogels include acquafilcon, asmofilcon, balafilcon, comfilcon, delefilcon, enfilcon, fanfilcon, formofilcon, galyfilcon, lotrafilcon, narafilcon, riofilcon, samfilcon, senofilcon, somofilcon, and stenfilcon, verofilcon, including all of their variants, as well as silicone hydrogels as prepared in US Patent Nos. 4,659,782, 4,659,783, 5,244,981, 5,314,960, 5,331,067, 5,371,147, 5,998,498, 6,087,415, 5,760,100, 5,776,999, 5,789,461, 5,849,811, 5,965,631, 6,367,929, 6,822,016, 6,867,245, 6,943,203, 7,247,692,

7,249,848, 7,553,880, 7,666,921, 7,786,185, 7,956,131, 8,022,158, 8,273,802,

8,399,538, 8,470,906, 8,450,387, 8,487,058, 8,507,577, 8,637,621, 8,703,891,

8,937,110, 8,937,111, 8,940,812, 9,056,878, 9,057,821, 9,125,808, 9,140,825,

9156,934, 9,170,349, 9,244,196, 9,244,197, 9,260,544, 9,297,928, 9,297,929 as well as WO 03/22321, WO 2008/061992, and US 2010/0048847. These patents are hereby incorporated by reference in their entireties. Silicone hydrogels may have higher shape memory than conventional contact lenses.

Hydrogel lenses are viscoelastic materials. Contact lenses can form optical distortions if the lens interacts with either the package or any air bubble in the package. The extent of the optical distortions, and the length of time needed for the distortions to relax out will vary depending on the chemistry, and to a lesser extent, geometry of the lens. Conventional lens materials, such as polyhydroxyethyl methacrylate-based lenses like etafilcon A or polymacon have low loss modulus and tan delta compared to silicone hydrogels and may form fewer and less severe optical distortions as a result of contact with packaging. The incorporation of silicones (which generally increase the bulk elastic response), wetting agents such as PVP (which generally increase the viscous response) or coatings of conventional hydrogel materials (which may lower the elastic response at the lens interface) can alter the lens viscoelastic properties. Conventional hydrogel contact lenses and silicone hydrogel contact lenses having short or stiff crosslinking agents and or stiffening agent have short shape memories and may be less susceptible to deformation during storage. As used herein, high or higher shape memory hydrogels display optical distortions from contact with an air bubble or package of at least about 0.18 after 5 weeks of accelerated aging at 55°C. Viscoelastic properties, including loss modulus and tan delta, can be measured using a dynamic mechanical analysis.

The contact lenses can be of any geometry or power, and have a generally hemispherical shape, with a concave posterior side which rests against the eye when in use and a convex anterior side which faces away from the eye and is contacted by the eyelid during blinking.

The center or apex of the lens is the center of the lens optic zone. The optic zone provides optical correction and may have a diameter between about 7mm and about 10mm. The lens periphery or lens edge is the edge where the anterior and posterior sides meet.

The wetted lens is the contact lens and any residual packaging solution attached to it after packaging solution drainage.

Embodiments may include a lens support surrounded by a sealable cavity also interchangeably referred to as a chamber. The cavity may have any convenient form and may comprise a package base and at least a lid, each of which are described in detail below. As used herein, the phrases "the lid", "a lid", "the base" and "a base" encompass both the singular and plural. The lid and package base are sealed to each other to form a cavity which holds the contact lens, support and packaging solution in a sterile state during shipping and storage prior to use. The contact lens package is made from materials which are compatible with the contact lens and solution, as well as retortable and biologically inert.

"Film" or "multilayer film" are films used to seal the package and are often referred to as lidstock. Multilayer films used in conventional contact lens packages may be used in the packages of the present invention as the base, a component of the lid, or both. Multilayer films comprise a plurality of layers, including barrier layers, including foil layers, or coatings, seal layers, which seal the film to the rest of the package, and may also comprise additional layers selected from peel initiation layers, lamination layers, and layers that improve other package properties like stiffness, temperature resistance, printability, puncture resistance, barrier resistance to water or oxygen and the like. The multilayer films form a steam sterilizable (retortable) seal. The multilayer film can include PET, BON or OPP films layers to increase stiffness and temperature resistance, or to EVOH or PVDC coatings to improve barrier resistance to oxygen or moisture vapor.

An "unopened state" or "unopened" as used herein refers to a contact lens package that is closed and houses a contact lens in solution.

An "opened state" or "opened" as used herein refers to a contact lens package after the sterile seal has been broken. Depending on the context described herein, the open state extends to the state of the package when the user has manipulated the package to cause the lens to be lifted out of the packaging solution for transfer by the user. A "wearer" or "user" as used herein refers to a person opening a contact lens package. The user is generally referred to as the person who both opens the package and transfers the contact lens contained therein to their eye. However, the user in some contexts may be a person handling the lens package on behalf of the wearer, such an eye care provider ("ECP") or another individual demonstrating for or assisting the wearer.

Packaging solution is any physiologically compatible solution, which is compatible with the selected lens material and packaging. Packaging solutions include buffered solutions having a physiological pH, such as buffered saline solutions. The packaging solution may contain known components, including buffers, pH and tonicity adjusting agents, lubricants, wetting agents, nutraceuticals, pharmaceuticals, in package coating components and the like.

The package base may form the bottom of the package. It can be made from any material suitable for packaging medical devices, including a polymer. The bowl polymer material may be any polymer material that can be injection molded, and provide contact lens packages having a shelf-life of at least one, two or five years and are compatible with the chemical and physical properties of the lens, packing solution and any additives which may be included therein. The bowl polymer material may be selected from any of the foregoing materials. The bowl polymer material may preferably be polypropylene having a melt temperature greater than about 145°C, COP, COCs and blends of polypropylene blended with COPs or COCs. Examples of polypropylenes include metallocene catalyzed polypropylene polymer and co-polymer, Zielgler-Natta catalyzed polypropylene polymer and co-polymer. Examples of suitable grades of polypropylene include ACHIEVE 1605 (metallocene catalyzed PP homopolymer) and PP1264E1 (PP homopolymer, MFR =20g/10min) from ExxonMobil; Braskem CP360H (homopolymer), F350 HC2 (high crystallinity homopolymer, MFR=35), from Braskem; Borealis RF366MO

(random copolymer with nucleating and antistatic agents), BJ380MO (heterophasic copolymer, controlled rheology with nucleating and antistatic agents) from Borealis; Moplen HE649T (homopolymer) and HP301R (homopolymer) from LyondellBasell; SABIC 512A (controlled rheology PP homopolymer); Formolene 4111T and Formelene 4142T from Formosa Plastics; FHR 11T55V, FHR P4C5N-046, FHR P4C6N-041 from Flint Hills Resources; and Total MR2001 (homopolymer material), Total M3766 (metallocene catalyzed PP homopolymer) and Total PPH10099 (controlled rheology PP homopolymer) from Total Petrochemicals. The polypropylene may have a melt flow range of about 15 g/10 minutes to about 44 g/10 minutes as determined by ASTM D-1238-10 "Standard Test Method for Melt Flow Rates of Thermoplastics by Extrusion Plastometer", or similar known methods. The polypropylene may be pristine, or may have undergone a controlled rheology process to increase its melt flow rate.

The packaging lid generally resides at the upper portion the package and seals with the base to form a cavity containing at least a portion of the lens support, lens, and packaging solution. The lid may be made from any material suitable for packaging medical devices, including a molded sheet of foil or plastic, laminate films, or plastic. Packages comprising plastic for one structure and foil or laminated films as the other, or packages comprising foil or laminated films as the outer layer for the lid and base are known in the art and are examples of suitable combinations.

References throughout this description to injection molding processes and the use of materials conventionally applied to injection molding should be understood as exemplary. Those of skill in the art will appreciate that other means of manufacture are possible within the scope of the appended claims, including but not limited to alternative molding processes, thermoforming, 3D printing, and the like. Likewise, references to heat seals and heat sealing are exemplary to embodiments described herein. Other means of securing packaging components will be apparent to those skilled in the art, including the use of adhesive, glue, thermal bonding, welding such as heat, ultrasonic or laser welding, or a mechanical trap, and the like.

Certain aspects of the invention may serve to reduce or prevent significant optical damage to the contact lens due to interactions with air bubbles or the interior of the lens package that may arise during storage or transit due to gravitational or other forces, such as mechanical pressure being applied from outside of the package. As used herein, significant optical damage means a root-mean-squared (RMS) value equal or greater than about 0.08pm.

With reference to the figures, FIG. 1A illustrates an exemplary contact lens package according to an embodiment, and FIGS. 1B-1D illustrate steps of handling a contact lens package 100 containing a contact lens 138 in packaging solution (not shown) according to an exemplary embodiment of the present invention. An unopened contact lens package 100 having a lid 106 and a base 110 is shown at FIG. 1A. In this embodiment, the lid 106 is a multilayer film, also referred to herein as the foil, and the base 110 is composed of a thermoplastic polymer, such as polypropylene plastic. While in this embodiment the lid 106 takes the form of a relatively flexible material (i.e., multilayer film) and the base 110 a relatively rigid material, it should be appreciated that other embodiments may include substantially rigid components for both the lid and the base. For example, in some embodiments, the base and lid both could be composed of a polypropylene plastic or other relatively rigid material. Base 110 includes a pivot line 114 along which a portion of the base that forms a lever 118 that can hinge when force is applied to the lever 118. The force applied to activate the lever 118 in this embodiment may comprise simultaneous downward and lateral moments. Base 110 further includes several optional finger engagement features 122a and

122b to assist the user with handling the contact lens package during the opening process. A finger dimple 122a may be sized to accommodate a finger or thumb of the user is disposed at the end of the base 110 proximal to the user and a foot 122b at the distal end of the base 110. Finger dimple 122a in this embodiment is also angled downward such that a force, e.g., pressure having one or both of a downward and lateral moment applied by a thumb of the user, causes the lever 118 to hinge downward at the pivot line 114. Foot 122b The foot 122b provides a large area to rest the finger or thumb and facilitates the application of the counter force necessary to cause the lever to hinge. Package 100 in this embodiment is further configured with a profile that slopes from proximal to distal end to further encourage a downward moment at the lever, for example when the lever is pressed down or the when the package is squeezed by the user, i.e., when the user applies pressure by hand at opposing ends of the package, i.e., via a finger at one end and a thumb at the other. In this embodiment, package 100 is configured such that the squeezing forces are applied at the distal and proximal ends. This design also permits the package to be pressed against a solid surface, e.g., a countertop to activate the lever 118. However, alternative embodiments are possible whereby the opposing forces involved in squeezing are applied at one or multiple opposing ends of the package, such as but not limited to the sides, left and right, of the package or portions thereof.

In a first step shown in FIG. IB, a user holds an unopened contact lens package 100 by its base 110. A user's grip upon the package 100 may be improved by one or more finger engagement features 122a and b positioned and configured to provide a more secure grasp upon the package and/or to aid in the application of force that, in a later step, causes a contact lens contained in the package to be lifted for presentation to the user and transfer to the user's eye. Finger dimple 106 (visible in Figure 1A) is positioned on lever 118 of base 110 and is sized for a thumb 126 of the user to grip the package. At the opposite end of package 100, the user may grasp the package as shown by positioning a finger securely under an overhang 122b (visible in Figure 1A) at the end of the base 110. In the case of a foot feature such as 122b, the surface region forming the foot may be curved or may be flattened to provide an increased area across which an opposing force can be supplied when the package is squeezed. Next, the user may open the package by opening the lid 106, which in this embodiment involves the user peeling open the foil 106 from the proximal end of the base 110 to the distal end in the direction shown by arrow 134, thus breaking a sterile seal between the foil (lid) 106 and base 110. Although not required, in this preferred embodiment the package is optimized for the user to grasp the base with one hand and peel open the lid 106 with the other hand.

As illustrated at the step shown in FIG. 1C, the package lid 106 has been opened, either by complete removal of the lid as shown in the illustration or, alternatively, by partial removal sufficient to substantially expose lens cavity 136, which houses a contact lens 138 in packaging solution (not illustrated) above a lens support 140. With the package 100 open, the user then applies a force 142 to lever 118. In this embodiment, the package is configured to be squeezed by the user whereby the user's hand or hands supply opposing forces 142 and 146 at the proximal and distal ends of the package, respectfully, thereby generating a more significant moment upon lever 118. Optionally, the lever 118 may lock into place when the lens support 140 has been raised to a predetermined lift angle, also referred to as a "lift angle" i.e., an angle at which the package is configured to present the lens to the user on the lens support relative to the horizontal plane defined by the lid. As described in more detail below with reference to Figures 2, 6, 7A and 7B, the action of locking lever and/or lens support at a particular lift angle may be accomplished by way of one or more locking mechanisms imparted into the base of the package. The act of "locking" via a lock mechanism means that the lens support is capable of retaining its position in place once it has reached a predetermined lift angle without the need for the user to continue applying force.

Turning to FIG. ID, at this stage the force applied to the lever by the user has caused the lens support 140 to lift the contact lens 138 out of the packaging solution (not illustrated). Ideally, a lens support is configured to lift a contact lens high enough above the package cavity that the lens is clear of the packaging solution, facing the user, and is thus visible and transferable from the support, but not so high that the lens slides off the support under the force of gravity. This may be accomplished by a lift angle 150 of between about 15° to 60° relative to the horizontal plane that defines the top of the base. A lens support preferably is configured so that, when lifted in this manner, packaging solution drains away from the contact lens sufficiently to enable single-touch lens transfer by the user, as in the exemplary the embodiment illustrated where the user transfers the contact lens 138 from the lens support 140 by tapping (also referred interchangeably as "dabbing") a convex surface of the contact lens 138 such that the tapping causes the contact lens to release from the lens support 138 and adhere to a finger 154 of the user.

In this embodiment, contact lens 138 conveniently is presented to the wearer in a convex orientation, meaning that convex side of the lens 138 is accessible to the wearer without the need to reorient the lens before placing the concave side of the lens onto the wearer's eye surface. It will be appreciated however that other orientations, such as the concave orientation of traditional blister packages, are possible within the scope of invention. Transfer of the contact lens 138 from the lens support 140 may be performed by a wearer's finger 154, either directly touching the lens or indirectly by way of an applicator film (e.g., as described in US20190046353) or other covering applied to the finger, or may be performed by another transfer means, such as a manual or automatic applicator device or tool. Upon transfer of the contact lens 138 from the package 100, the lens rests on the finger 154 (or other transfer means), as shown in the step illustrated, with the convex side of contact lens 138 against the finger 154 and the concave side of the lens 138 oriented for direct application to the user's eye surface. While single-touch/dabbing of the lens is the preferred mode of lens transfer, it is noted that the traditional "pinching" of the lens from the lens support is possible.

Turning now to FIGS. 2 and 3, FIG. 2 illustrates a perspective view of contact lens package 100 in an opened state in which lens support 140 has lifted contact lens 138 out of the packaging solution (not illustrated). FIG. 3 illustrates an exploded perspective view of contact lens package 100. Contact lens package 100 includes base 110 that has a proximal end (A) and distal end (B). Base 110 includes a cavity 136 that houses a contact lens 138 in packaging solution and a lever 118 configured to hinge along a pivot line 114 in the base when a force is applied to lever 118. In this embodiment, lever 118 is formed as a portion of a unitary component that composes the base 110. More specifically, base 110, including lever 118, is formed as a unitary injection-molded polypropylene plastic part. Alternative materials and processes for forming the base will be appreciated by those skilled in the art, including thermoforming and 3D printing (using materials such ABS, PLA, HIPS, PETG, Nylon, or others). Preferably, the material used for the base is relatively rigid, having a glass transition temperature (T g ) of about 125C as measured in accordance with ASTM D1238-10 (Standard Test method for Melt Flow Rates of Thermoplastics by Extrusion Plastometer). In this embodiment, pivot line 114 is defined by a thin, folded region in the base in a linear configuration along a horizontal axis along which it lever 118 hinges. This thinned region provides sufficient relief along a line in the base material to cause lever 118 to hinge at the desired position when force is applied to the lever by a user. The use of one or more thinned regions is merely one of myriad ways that a pivot line may be defined within the scope of the invention. For example, in other embodiments in which the lever is formed in the same material as the remainder of the base, the pivot line may be created by creasing the plastic laterally at the desired location, by molding the material to be thinner along the pivot line, and/or by cutting, etching or otherwise imparting a pivot line into the base material. Alternatively or additionally, one or more voids may be imparted in the base material along the intended pivot line to encourage the plastic material to bend along the intended axis. Furthermore, in embodiments in which the lever takes the form of a discrete component, the pivot line may merely represent the horizontal interface between the lever and the remainder of the base. In such embodiments, hinging along the pivot line may be effected by a hinge component, a rotatable interlocking attachment, or the like. It should be appreciated that alternative embodiments are possible within the scope of the invention in which the lever is a discrete component coupled to the remainder of the base by an attachment means. For example, a lever may be formed as a separate injection molded part and then attached to a separately molded (or printed, etc.) part that forms the rest of the base via an array of attachment means, including laser welding, ultrasonic welding, adhesive, mechanical attachment, heat staking, or the like.

The underside of the base may be sloped, as in the embodiment illustrated, to enable the packages to "nest" thereby allowing more compact secondary packaging during storage and transport in addition to reducing the amount of primary packaging material and packaging solution necessary to keep the contact lens hydrated. In this example, base 110 slopes from the proximal end (A) to distal end (B) at an angle of approximately 10 9 and has a footprint of approximately 29mm in width, 44mm in length, and 12mm in height. Preferred slopes have a range of between about 0-20 9 , but the slope may be made even steeper, e.g., about 20-30 9 , as desired. The base includes a well, i.e., cavity 136, formed in the tapered area in which the contact lens 138 and lens support 140 are housed when package 100 is unopened. In this embodiment, the cavity has a volume of approximately 2240pl, which is dosed with approximately 2080pL of packaging solution, which is sufficient to fully submerge the contact lens 138 within the cavity 136. The foil lid 106 is secured to the base 110 via a retortable seal formed between bead 152 on the upper surface of the base around the perimeter of the cavity 136. This seal may be formed by well-known heat-sealing techniques and associated apparatuses.

Finger engagement feature (dimple) 122a is sized to accommodate a finger or thumb of the user is disposed at the end of the base 110 proximal to the user. Finger dimple 122a in this embodiment is also angled downward such that a force, e.g., pressure applied by a thumb of the user, causes the lever 118 to hinge downward at the pivot line 114. The position of the finger dimple position of this dimple and the finger of the user relative to the pivot line affects the amount of squeeze force necessary to cause the lever to hinge along the pivot line. In this example, the dimple depth below the pivot line is 4.9mm when measured from the seal level to the base of the dimple. The horizontal distance between the dimple and the hinge line affects the lever force required to bend the hinge. In this example the end of the lever 118 is 14.5mm from the pivot line 114.

A lens support 140 is coupled to the lever 118 so that force applied to the lever 118 causes the lens support 140 to lift the contact lens 138 out of the packaging solution. In the embodiment illustrated, lens support 140 is a separately molded (or printed) component that is fixedly attached to the lever 118 portion of the base. Attachment is made here via laser welding, whereby tab portion 163 is welded to a corresponding recessed region 164 in base 110. Numerous other means of attachment other than laser welding are possible within the scope of the claims, including e.g., ultrasonic or RF welding, adhesion, mechanical clipping, heat staking and the like. Further, it should be noted that in alternative embodiments the lens support may be formed as part of the same unitary molded or printed component as the lever and/or the entire base. In many embodiments, such as the one illustrated in which the pivot line is formed by a fold in plastic or other substantially rigid material, the pivot line may have a thickness, i.e., it may not be perfectly sharp. In these cases, such separation may be needed between the point of attachment and the pivot line in order to maximize the lifting angle for a given squeeze force. As discussed in more detail with reference to FIG. 6 and 7A and 7B below), package 100 also includes a locking mechanism (in this example, 159a and 159b) that causes lever 118 to lock into place when the lens support 140 reaches a lift angle that has been predetermined to be high enough to permit sufficient drainage of packaging solution away from lens 138 but not so high that lens 138 slides off of the lens support.

The underside of a lid 106, as can be seen in FIG 2., includes a lid insert 170 having multiple lens facing surfaces 168, which in this embodiment are formed as projections extending downward toward the convex surface of lens 138. The lens facing surfaces 168 are generally shaped to mirror the convex lens surface of the contact lens to be housed in the lid cavity 136. The lens facing surfaces 168 serve to align the contact lens over the lens support, prevent the lens from folding or distorting and to protect the contact lens against significant optical damage due to gravitational or air-induced forces. In some embodiments, lens facing surfaces also serve as air entry guides by guiding air entering the package over the contact lens to reduce the incidence of the contact lens sticking to the package upon opening. In this case, the lens facing surfaces are provided on a molded plastic lid insert 170, wherein the lid insert 170 is attached to an inner surface of the foil lid 106 by a heat seal along heat sealing surfaces 172a-d, which are distributed and positioned to avoid the lid insert 170 from shearing away when the user opens the multifoil film that forms lid 106. But in other embodiments, for example where the lid is substantially rigid, the lens facing surfaces may be integral to the lid rather than a separate component. It will be understood that all features described as being imparted upon a lid insert could be applied equally to embodiments in which the same features are made integral to the lid.

Lens facing surfaces of the present invention serve to support the lens when loaded by forces to avoid or reduce significant optical damage. For example, gravitational forces and interactions with air bubbles in the packaging solution can result in optical damage if not properly counteracted. In one aspect, lens facing surfaces, as in the lens facing surfaces 168 of the illustrated embodiment, include a relatively large contactable surface area preferably at least about 20 percent of the lens convex surface area or as large as possible while still accommodating any desired air egress channels. The contactable surface area is understood to mean the area of contact between the lens and lens facing surfaces when the lens is loaded, i.e., placed into contact under an applied force, such as but not limited to gravity or air bubble interaction. The contactable surface area determines the pressure exerted on regions of the lens when/if it is loaded. The larger the area, the more the pressure is reduced. In the embodiment illustrated, the lens facing surfaces 168 have a contactable surface area of about 40 percent of the lens 138 convex surface area, and more precisely about 90mm 2 conventional contact lens having a surface area of approximately 215mm 2 . As discussed in more detail below, it is preferable that at least 10% of the surface area above the lens be left exposed to promote air entering the package to travel between the lens facing surface and the lens to reduce any tendency of the lens to stick to the lens facing surfaces/lid insert.

The lens facing surfaces 168 are also spaced apart to define air egress channels 169 allow air, in particular air bubbles in the packaging solution, to travel away from the contact lens into the cavity 136. The spacing also allows the lid structure to flex as the foil lid is peeled, thus avoiding the lid structure scraping and damaging the lens. Air egress channels permit smaller air bubbles to escape from the area around the lens surface while simultaneously avoiding larger bubbles entering the space above the lens. Toward this end, preferred embodiments include at least two air egress channels each having a width of between about lmm-2mm or preferably between lmm-1.5mm and, specifically 1.1mm in the embodiment illustrated.

Lid insert 170 is attached to an inner surface of the lid 106 in this embodiment by heat seals between the multilayer film lid 106 and the planar surfaces 172a-d on the upper side of the lid insert. As discussed in more detail later herein, alignment of a lid insert with the base during the heat-sealing process and during storage may be aided by the inclusion of one or more alignment features in the base and/or lid insert. For example, alignment features in the embodiment illustrated take the form of projections 174 of lid insert 170 and projections 176 in cavity 136 of the base 110. The projections 174 cooperate with ledges 176 to resist rotation and lateral motion of the lid insert 170 when pressure is applied to seal the package 100 or during storage.

Referring now to FIG. 4, illustrated is a close-up view of a lid insert 170. The position of projections 174a and 174b of lid insert 170 correspond to ledge 180 in base 110. Projections 174a and 174b and ledge 180 cooperate as an assembly to restrict rotational and lateral movement of the lid insert 170 and to prevent the lens support from lifting (other than the expected time during opening) and to ensure that the lens is not compressed in the package due to external forces when heat sealing pressure is applied during assembly or during storage, transport, or when the user opens the package. In this sense, projections 174a and 174b and ledge 180 also function as a lockout feature to prevent lid features, such as lens facing surfaces 168 (whether integral to the lid or included on a lid insert) from impinging on the lens when pressure is applied overhead, such as when the lid is sealed to the base or when the lid insert, if any, is sealed to the lid. Other lock-out features may be included to stop the lens support from impinging into the lens (e.g. due to bending the pack at the pivot before it is open) by making a point of contact between the lens support and the lid insert. One function of the ledge 180 is to avoid a pinch point for the lens perimeter during assembly. The height of the ledge above the cavity floor is made sufficient so that the lid insert and/or lens facing features of the lid are stopped at a height above where the lens is housed beneath. It should be understood that a projection and/or ledge is yet another exemplary lockout feature of many possibilities. To be sure, the lid insert could be locked out at any level (e.g. level with the base of the lens, level with the top of the pack).

FIG. 5 illustrates a cross-sectional view of a contact lens package 100 in an unopened state. Specifically, FIG. 5 illustrates the cross-section created across a cut running longitudinally along the center of package 100. As shown, package 100 is configured such that when in an unopened state, contact lens 138 is housed between lens support 140 and lens facing surfaces 168. Packages of the invention preferably minimize contact with the contact lens when the package is closed, and the lens is substantially suspended in packaging solution. Ideally, the optical zone of the lens is free floating and contact with the lens support during storage is transitory or non-existent.

Depending on the buoyancy of the lens in the package solution and the orientation, the lens may rest on its peripheral edge on the floor of the cavity in the base of the package or on its convex surface on the lens facing surfaces. As illustrated, contact lens package 100 is in a lid-up orientation in which the peripheral edge of the contact lens rests on the floor of the cavity 136 in the base 110.

Cavity 136 preferably is substantially filled with packaging solution, provided however that manufacturing processes may not permit sealing the packaging under vacuum pressure. In such cases, it is anticipated that some amount of air will become entrapped in the cavity 136. If these air bubbles are not managed, they may interact with the lens and cause significant optical damage to the lens. Accordingly, peripheral volumes in the cavity, i.e., volumes in the cavity that are peripheral to the location of the lens over the lens support, may be provided. Ideally, such volumes should be provided at the distal and proximal ends of the package, such as 139a and 139b of cavity 136 of package 100, so that the air bubbles have a place to reside regardless of the orientation of the package during transport or storage.

The base 110 of package 100 also includes a central dimple 184 imparted beneath the lens 138. The central dimple 184 is in this example is dome shaped to generally track the concave side of the lens 138 in order to provide additional support beneath the lens 138. The central dimple 184 also serves to reduce the amount of packaging solution required in the package and to reduce the amount of headspace, i.e., the amount of space in which air bubbles can situate themselves and exert forces on lens 138 that could produce optical damage.

Referring to Figure 6, contact lens package 100 is illustrated in an open state in which the lens 138 is lifted from the packaging solution in a position for transfer by the user. The angle at which the lens emerges from the packaging solution, defined herein as the "emergence angle" (P) (not illustrated) affects the manner and extent to which packaging solution drains from the lens and can therefore impact the likelihood for consistent single-touch lens transfer. It is observed that it is advantageous to configure the lens support 138 relative to the base 110 and lever 118 such that upper side of the lens (i.e., upper side when the lens is in a lifted position) the 138' of lens 138 emerges from the package solution before the lower side 138" when the user actuates lever 118 to lift the lens. Ideally, the package should be configured so that this sequence (i.e., the upper side emerging first) remains true whether the user tilts the package toward or away from themselves within an expected range (10 degrees forward or backward) when opening. As the lens emerges from the packaging solution, it is observed that a film of packaging solution remains intact on the lens support throughout the lifting motion. By causing the upper side 138' to emerge first, there is a bulk flow of fluid from the distal end of the lens 138' to proximal end of the lens 138". This encourages the packaging solution to continually drain along a path that is maintained along the lens support 138 and, in some embodiments, through a drainage channel of the lens support (as discussed in more detail with respect to Figures 8A and 8B below). Conversely, were the lower side instead to emerge before the upper side, the film of packaging solution would be more prone to breakage before the fluid has had a chance to drain and, consequently, packaging solution would be more likely to become stranded between the lens and lens support, thus impeding consistent single-touch transfer.

The emergence angle is a function of at least two aspects of the lens support: the lever length and the primary lens angle. The "lever length" (L) is defined as the distance between the pivot point 114 and the apex of the lens when resting, centered on the lens support. The "primary lens angle" (0) is defined as the angle of the lens in the cavity relative to the plane defined by the lid when the package is unopened. Table 1 below provides a range of values for the emergence lens angles produced by various combinations of lever lengths ranging from 11mm to 16mm and primary lens angles ranging from -4 to 20 degrees.

Table 1. (Emergence angle as a function of lever length and primary lens angle)

It is observed that an emergence angle greater than 0 degrees may support consistent transfer, however, an emergence angle of at least about 5 degrees, with 10 degrees being preferable, allows the pack to be tilted slightly away from the user without impeding the desired drainage effect. Lower emergence angles may permit consistent single-touch lens transfer, although without providing tolerance for pack tilting. Package 100 is configured so that lens support 140 has a lever length (L) of 13mm and a primary angle (0) of 10 degrees, which produces an emergence angle of approximately 10 degrees. As noted, however, myriad combinations of lever lengths and primary angles are capable of producing a myriad of acceptable emergence angles, including but not limited to those listed in Table 1. Package 100 is also configured with a locking mechanism (described in more detail in reference to Figures 7A and 7B) that locks the lens support 140 at a lift angle (a) (i.e., an angle at which the package is configured to present the 138 lens to the user on the lens support 140 relative to the horizontal plane 190) of about 60 degrees. The lift angle is preferably between about 45 to 75 degrees and ideally selected to be high enough to allow sufficient drainage of the packaging solution away from the lens but not so high that the lens slides off of the support, appreciating that the maximum angle possible before the lens slides off of the support will depend on the specific design of the lens support. The minimum for a is also determined by the clearance required between the base of the lens and the surface of the packaging solution. At least around 3-5mm of clearance will allow the packaging solution film the between the lens and the solution surface to break.

Referring now to Figures 7A and 7B, illustrated is the base 110 of a contact lens package with locking mechanisms 159a and 159b in an unlocked and locked state respectively. In this example, two locking mechanisms 159a and 159b are employed on either side of the base 100 where the lever 118 portion of base 110 is configured to hinge along pivot line 114. As shown in the zoomed in view in Figure 7B, in this example the locking mechanism takes the form of a snap-fit latch 159b having an upper tooth 192 and a lower tooth 194. The teeth 192 and 194 are shaped so that tooth 194 slides over the side of tooth 192 when lever 118 is depressed before becoming pinned under upper tooth 192 when the lever 118 and lens support 140 affixed thereto reach the predetermined lift angle. The pinning of tooth 194 under tooth 192 allows the lens support 140 to retain its position in place once it has reached a predetermined lift angle without the need for the user to continue applying force. It will be appreciated that other embodiments could use just one or alternatively more than two locking mechanisms to achieve the same locking functionality and that any number of alternative types of locking mechanisms could be substituted, such as but not limited to a ratchet, an adhesive, and/or a pair of male and female friction-fit features. The inclusion of a locking mechanism may benefit the handling experience in numerous ways, including at least that it 1) ensures that the lens support presents the lens to the user at an angle calculated to provide sufficient drainage without the lens sliding off the support; a locking mechanism also 2) allows the user to remove their thumb or finger from the lever after the lifting the lens so that the same hand that lifted the lens may then be used to transfer the lens from the lens support, e.g., preferably by dabbing but also by pinching or by a lens insertion tool or other means; or allow the user to set the package down on surface if desired.

In another aspect, base 110 includes a secondary support 196. Secondary support 196 in this example represents the upper side of the central dimple 184 formed in the underside of base 110, as discussed above with respect to Figure 5. Secondary support 196 has a convex, partial domed profile that partially mirrors the contact lens's profile. Recessed areas 198a and 198b are imparted into secondary support 196 in a shape and position that allows the lens support (i.e. the primary lens support) to nest together with the secondary support to form a dome shape that mirrors the concave side of the lens 138 when the package 100 is in its unopened state. This may be referred to as a split-support arrangement, whereby the lens support 140 lifts the lens 138 upon opening, such that the secondary support provides support to the lens only when the package is unopened (i.e., during storage, shipment, and handling) but not the lens when the package is opened, and the lens is presented for transfer when the lens 138 is supported only by (primary) lens support 140. This arrangement reduces the excess wetted area that may otherwise exist between the lens and lens support were the entire support system lifted with the lens. Split-lens support arrangements may provide multiple benefits, including the secondary support 196 filling more volume within the cavity 136 thereby reducing the amount of solution required to hydrate the lens and reducing lens damage, restricting air bubble movement, and discouraging lens inversion. In achieving some or all of these benefits, it is preferable but optional that the lens support, whether singular or split among secondary and primary and potentially other components, fills the space under the contact lens and under the lens's peripheral edge as much as possible.

Lens supports of the present invention may take myriad shapes and forms capable of lifting the lens out of the packaging solution when the user applies force(s) to the package, such as squeezing the package as described with respect to embodiments herein. However, as mentioned it is preferable that the lens support keeps the lens in the desired convex orientation (bowl down relative to the base) and position (centered over the support) during shipping and storage. Ideally, the lens support may provide an open structure under the lens to allow, upon opening, the packaging solution to drain from the lens and support without trapping water between the support and the underside of the lens. It is also preferable that the lens support provides sufficient support to the lens to prevent the lens from collapsing onto, rotating off or translating across the support. This allows the apex of the lens to be supported by the lens's own elastic stiffness, or to minimize sinking of the lens apex while limiting the contact area between the support and lens. Too much contact between the support and the lens after solution draining, and water trapped between the support and the lens can create surface tension between the lens and water on and around the lens support that is greater than the surface tension between a wearer's finger and the lens, interfering with efficient lens transfer. The sum of the contact between the lens and the lens support when the package is open, and the solution drained from the lens and lens support is the total wetted contact area, which may be less than about 30 mm 2 , less than 25mm 2 or less than 20mm 2 and is distributed at least around the lens periphery, as described herein. "Wetted contact area" as used herein refers to the direct solid contact area between the lens support and the lens added to the area of any menisci, reservoirs, or solution bridges that form between the lens and lens after the lens is lifted and packaging solution is allowed to drain two seconds and measured in accordance with the measurement protocol described below with respect to Figure 9.

For lenses made from polymers with longer shape memory, the lens support may be designed to limit contact between the lens and support during storage. Such contact may be distributed around the lens peripheral edge. Contact between the lens optic zone, lens support and lid interior (including any air entry guides) may be transitory or there may be no contact between the optic zone and support, lid or air entry guides. Lenses, such as conventional hydrogels, having shorter shape memory, are less prone to distortion from packaging contact, and can have the contact points distributed around the periphery and throughout the lens profile, including the lens center zone (about 9mm, or about 5mm diameter).

The lens supports of the present invention preferably allow, upon dabbing, both the fingertip and lens to deform to match each other's shape, without causing lens inversion or damage to lens during removal from too much pressure during dabbing. Thus, an aspect of the removal of the lens from the present packages may be to control the ratio of the contact area between the finger and lens as compared to the area between the lens and the lens support so that the contact area between the finger and lens exceeds the contact surface area of the lens support on the lens underside. This will ensure that surface tension between finger and lens exceeds surface tension between lens and lens support. Thus, the lens will adhere to the finger for lens transfer and placement onto the eye.

The lens support preferably provides at least 2, at least 3, 3 to 14, 4 to 14, 3 to 8 or 4 to 8, 4 to 6 or 6 points of contact with the contact lens edge along the peripheral supports and may take the form of a continuous, also referred to as a "closed-circuit," design in which the lens support has no ends or breaks and contact with the lens occurs at various points along a continuous support structure. When two peripheral supports are used, they may be wider to provide stability, without exceeding the area of contact desired for consistent single-touch lens transfer. The peripheral points of contact prevent the lens from rotating off the lens and can be distributed in a number of configurations, in which the space between the furthest adjacent contacts is less than the diameter of the lens. As the number of peripheral supports is increased the likelihood of residual packaging solution forming films between adjacent peripheral supports and solution bridging between the support and lens may be increased during drainage. Peripheral supports with less than 50% open space such as those in the form of a screen or strainer, generally provide insufficient drainage to insure single-touch lens transfer. Likewise, too much contact between the support and the lens after solution draining, and water trapped between the support and the lens, can create surface tension between the lens and water on and around the lens support that is greater than the surface tension between a wearer's finger and the lens, interfering with efficient lens transfer. The width of the constituent support members of the lens support vary between the limits of the selected molding process and widths necessary for efficient packaging solution drainage upon opening. Suitable widths include about 0.5 to about 1.5mm, 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. Lens supports may achieve sufficient drainage of packaging solution from the lens to enable single-touch transfer through one or a combination of drainage techniques referred to herein as channel drainage and back drainage. Channel drainage involves the formation of films on the lens support of channel members along which packaging solution is channeled away from the lens under the force of gravity when the lens support is lifted. Back drainage, on the other hand, refers to enhanced drainage from the underside of the lens directly into the packaging solution reservoir where the lens rests on the lens support. This area underneath the apex of the lens tends to trap packaging solution due to the hydrophilicity of modern contact lens materials. Enhanced back drainage may be achieved in some embodiments by designing the lens support with a central opening beneath the apex of the lens of at least about 12mm3.

Referring then to Figures 8A and 8B, illustrated is exemplary lens support 140 in a side and a top view, respectively. Lens support 140 represents an example of a lens support that leverages a hybrid of back drainage and channel drainage to clear packaging solution from the lens sufficiently to enable single-touch transfer. Lens support 140 includes a closed-circuit design including a central support portion comprised of central support sections 200a and 200b having a partially circular configuration having an inner diameter of approximately 6mm. Central support sections 200a and 200b are elevated 1mm relative to the lens base.

The design of lens support 140 creates central opening 212 having a 6mm diameter to allow the packaging solution to back drain from the lens and lens support 140 when the package is opened, and the lens support lifted from the packaging solution and an unsupported region sufficient to allow the lens apex to deform slightly under dabbing pressure and thus achieve sufficient contact area with the finger (or other lens transfer means) to effectuate single-touch transfer. The sizing of central opening 212 also permits the apex of the lens to be supported by the lens's own elastic stiffness, and to minimize sinking of the lens apex while limiting the contact area between the support 140 and lens. The design also provides sufficient support to the edge of the contact lens at points A, B, C, and D along the peripheral support sections 201a-d. This configuration sufficiently reduces the wetted contact area between the lens support 140 and the contact lens to about 22mm 2 after allowing 2 seconds for drainage after lens support 140 is lifted, and the measurement is taken in accordance with the measurement protocol described herein with respect to Figure 9. The design of lens support 140 prevents the lens from collapsing laterally in part by the peripheral support sections 201a-d causing packaging solution drainage of films 206, which form initially on support 205a and 205b, more stable as well as by holding the sides of the lens in tension until the lens is substantially drained.

The distal end 208 of lens support 140 is open to reduce the incidence of the lens catapulting from the lens support during lifting, as well as to facilitate the lens support clearing the lid insert 170 when lens support 140 is lifted. The lens support also includes a drainage channel 202 to assist with lens drainage. The drainage channel 202 is formed by channel members 204a and 204b, which extend from the tab portion 163 of the lens support 140, and it has a width of about 2mm and a length of 2.3mm. When the lens is lifted film(s) of packaging solution form along the lens support members (central and peripheral). A drainage channel, when present, cooperates with the lens support to create a temporary film of packaging 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 packaging solution between the back of the lens and lens support structures when the package is opened, and the lens support is raised or tilted out of the packaging solution. Drainage channels comprise at least one channel member. The drainage channel comprises a gap between two adjacent members or a when a single member is used, a split in the single member. For lens supports without a full peripheral ring, the drainage channel gap may begin at any point inside the lens periphery. The drainage channel can extend at least 2mm, about 2 to about 4mm or about 2.5 to about 3.5mm in length beyond the lens periphery. The drainage channel gap may provide a space outside the periphery of the contact lens for airflow, ensuring that air and packaging solution from the concave surface of the lens can, upon opening, drain without sucking the lens down onto the lens support. As can be seen in Figure 8B, lens support 140 is also configured with an offset from the horizontal plane of tab 163 so that the side supports 205a and 205b of the lens support 140 slant downward at the primary angle (0) of 10 degrees. Lens support 140 has a lever length (L) of 13mm.

It must be emphasized that the lens support embodiments illustrated and described herein are merely two among of myriad embodiments of a lens support within the scope of the invention as set forth in the appended claims. To be sure, a number of additional illustrative but non-limiting exemplary lens supports are depicted in Appendix A.

A protocol for measuring wetted contact area is described below with reference to Figure 9, which shows a digital image used to make the wetted contact area measurement at various stages of digital processing. First, at a step a contact lens package cavity is filled with 16 parts packing solution to 1 part dye (e.g., Stone England Claret writing ink) such that, at a minimum contact lens and lens support are submerged. Next, the lens support is lifted according to normal operation of the package, such as by depressing on depressing the lever (not shown). The lens support and lens are maintained in their fully lifted position or dab angle, according to the particular package design. The lens support is then removed, placed on a white surface and imaged using a digital camera (having at least 12 megapixels) from directly above approximately 4 inches above the lens support in a neutral lighting environment to produce an image such as image 902. The image used for measurement should be captured within 30 seconds of being removed from the package to avoid evaporation losses.

At a next step, the image 902 is digitally scaled according to the diameter of central section (6mm in diameter in this example). The image is then converted to black and white using a threshold selected at the level that any dark sections that are not obviously attached to the lens support are removed (e.g., converted to white). Any areas of solid contact with the lens support are also converted to white to avoid doublecounting. This distinguishes meniscus areas from fluid film attached to the lens.

Next, the image is split into sections by cropping the image into three different images 903a, 903b, and 903c (at 6 mm diameter, 8 mm diameter, and 14.2 mm diameter) to consider the distortion due to vertical projection at the edges of the lens. The white and black pixels of each section are then counted, and the meniscus area is calculated as the ratio of white to black pixels multiplied by the 3D surface area of each section on the back curve geometry of the lens. Finally, the total wetted area is calculated as the meniscus area added to the solid area of contact of the lens support (which may be measured in CAD).

The foregoing description, for purposes of explanation, used specific nomenclature to provide a thorough understanding of the described embodiments. However, it will be apparent to one skilled in the art that many of the specific details are not required in order to practice the described embodiments. Thus, the foregoing descriptions of the specific embodiments described herein are presented for the purposes of illustration and description. They are not targeted to be exhaustive or to limit the embodiments to the precise forms disclosed. It will be apparent to one of ordinary skill in the art that many modifications and variations are possible in view of the above teachings.

The Summary and Abstract sections may set forth one or more but not all exemplary embodiments of the present invention as contemplated by the inventors, and thus, are not intended to limit the present invention and the appended claims in any way.

The foregoing description of the specific embodiments will so fully reveal the general nature of the invention that others can, by applying knowledge within the skill of the art, readily modify and/or adapt for various applications such specific embodiments, without undue experimentation, without departing from the general concept of the present invention. Therefore, such adaptations and modifications are intended to be within the meaning and range of equivalents of the disclosed embodiments, based on the teaching and guidance presented herein. It is to be understood that the phraseology or terminology herein is for the purpose of description and not of limitation, such that the terminology or phraseology of the present specification is to be interpreted by the skilled artisan in light of the teachings and guidance.

The packages of the present invention may be manufactured using known materials and processes. The packaging materials may be virgin, recycled or a combination thereof. The volume within the package cavity can vary depending on the design selected.

Not all the features described herein need to be incorporated into every package, and those of skill in the art, using the teachings herein, can combine the features to provide a wide variety of improved contact lens packages. In summary, the contact lens packages of the present invention incorporate several novel functionalities which may be combined in a wide variety of combinations as described herein to provide the desired improved and/or single touch packaging. The breadth and scope of the present invention should not be limited by any of the above-described exemplary embodiments but should be defined only in accordance with the following claims and their equivalents.

APPENDIX A