Note: Descriptions are shown in the official language in which they were submitted.
CONTACT LENS PACKAGES AND METHODS OF HANDLING AND MANUFACTURE
I. CROSS REFERENCE TO RELATED APPLICATIONS
This patent application claims the benefit of United States Provisional
Application No.
63/077,779 filed September 14, 2020; United States Provisional Application No.
63/077,784 filed
September 14, 2020; United States Provisional Application No. 63/124,835 filed
December 13,
2020, and United States Provisional Application No. 63/243,525 filed September
13, 2021.
II. 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.
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Date Regue/Date Received 2022-09-08
In view of the growing awareness around ocular health and the customer demand
for a
more convenient experience, a need has arisen for contact lens packaging that
enables a less
messy and more sanitary contact lens handling process. In one respect, it
would be ideal to
provide wearers of contact lenses with a "single touch" package¨that is, a
package whereby the
wearer of contact lenses can take the lens from the lens storage package with
a single touch of
one of his or her fingers, and then, with this single touch, position the lens
correctly on the eye.
In such a design, there would be no need for transfer and manipulation of the
lens from one
finger to another before placing the lens on the eye. Providing such a single
touch package would
not only streamline the lens preparation and insertion process; it would also
diminish the
possibility of dropping the lens or exposing the lens to additional bacteria
on a wearer's other
fingers as the lens is being prepared for orientation and insertion onto the
eye, and it also reduces
the possibility of touching the side of the lens which is intended to contact
the eye.
Design of a single touch lens package faces some distinct challenges. The
wearer ideally
should be able to consistently position the lens to adhere to the finger
during removal from the
package, and then the lens needs to consistently release from the finger onto
the eye. Contact
lenses (of both the reusable and daily disposable variety) each has its own
unique surface, bulk,
and geometric properties. Finger size and the force a contact lens wearer
imparts on the lens
during transfer can also vary. These factors can impact the process for taking
the lens from the
package onto the finger and then onto the surface of the eye. Among other
considerations: it
would be desirable for wearers to be able to drain away any packaging solution
which might
impact the ability of adhering the lens to the finger, as variation in the
amount of packaging
solution adhering to the lens and package can impact the process of placing
the lens on the finger.
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Date Regue/Date Received 2022-09-08
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),
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Date Regue/Date Received 2022-09-08
while at the same time prevent crushing or damage to the lens; ii) the lens
package should
maintain the hydration of the lens when stored to maintain the lens's
properties; and iii) the lens
in its package preferably should be configured so that when desired, it is
fully submerged in the
packaging solution, yet be cleared of such solution when ready to be
transferred from the
__ packaging; iv) the package generally should have a retortable seal and
contain both the lens and
solution; v) the package preferably should maintain the lens in the desired
convex orientation to
the wearer; vi) the lens should be positioned so that it can be easily removed
by the wearer; and
vii) the package ideally should allow the packaging solution to be effectively
drained away from
the lens upon opening of the packaging and prior to lens removal to enable
easier transferred to
the wearer's finger and then onto the eye.
Known packages that have sought to provide reduce-touch or single touch
orientations
fail to provide one or more of the above-noted desired attributes for a single-
touch package. For
example, W02014/195588, W02009/069265, JP6339322 disclose packages which
present the
lens in a convex, bowl down configuration. However, the lens support
structures substantially
match the shape of the contact lens, which provides undesirable contact area
between the lens
and lens support. These references are also silent as to mechanisms for
effective solution
drainage from the lens and lens support.
Similarly, U520200229560 discloses packages with lens supports that support
the concave
(anterior or front) surface of the contact lens, or grates that support the
contact lens peripheral
edge and allows packaging solution to drain through a grate to a bottom
chamber upon opening
the lens package. The foregoing noted deficiencies of the prior art are merely
exemplary and not
exhaustive.
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Date Regue/Date Received 2022-09-08
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.
III. 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. For example,
a contact lens package
of the invention may house a contact lens and packaging solution wherein the
package is configured to
lift the contact lens out of the packaging solution when the package is
squeezed by a user. The contact
lens package may have a lid and a base that includes a cavity that houses a
contact lens and packaging
solution and a lever configured to hinge along a pivot line in the base when a
force is applied to the lever.
The package may further include a lens support that intersects the pivot line
such that force applied to
the lever causes the lens support to lift the contact lens out of the
packaging solution in a position on the
lens support capable of single-touch transfer by a user. In some cases, the
lever is a discrete component
that is coupled to the base by an attachment means. The pivot line may be
defined by at least one void
in the base and may be imparted into the base by one or more of: a crease, a
cut, a thinned line, and an
etch or the like. The base of the package may be composed of plastic and the
lid may be a film. In some
cases, the base and the lens support and/or the lever and lens support are a
single unitary component.
A lens support may be coupled to the base by i) a laser weld; ii) heat; iii)
an ultrasonic weld; iv) an
adhesive, or the like. The base may include one or more finger engagement
features configured to aid a
user in grasping the package or direct the application of force such that the
lever hinges downward.
Possible figure engagement features includes a protrusion in the base at a
distal end of the package and/or
an overhang along at least a portion of the package's periphery. A dimple
sized to accommodate a finger
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Date Regue/Date Received 2022-09-08
or thumb of the user may be positioned at an end of the base proximal to the
user. Finger engagement
features may be paired such that one is positioned at an end of the base
proximal to the user and another
is distal finger engagement feature positioned at an end of the base distal to
the user. Alternatively, finger
engagement features may be positioned at any other opposed side or end of the
package.
The lid of the package may include one or more lens facing surfaces that
extends downward into
the cavity above the contact lens when the package is in an unopened state.
The lens facing surface and
lens support may be configured within the cavity such that the optical zone of
the contact lens is
suspended in the packaging solution between the lens facing surface and lens
support when the package
is in an unopened state. The cavity of the package may house the contact lens
in a convex position when
the package is in an unopened or opened state. And the lens support may have a
profile that does not
substantially match the contact lens's profile. When the package is an opened
state, the wetted contact
area between the lens support and the contact lens may be less than about
30mm2, less than about
25mm2, or less than about 20mm2. The package may include a lid insert having
at least one alignment
feature and/or one or more lock-out features.
IV. 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.
FIGS. 1A-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.
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Date Regue/Date Received 2022-09-08
FIG. 3 illustrates an exploded perspective view of a contact lens package
according to an
embodiment.
FIG. 4 illustrates a close-up view of a lid insert in a cavity of an
embodiment.
FIGS. 5A and 5B illustrate a cross-sectional view of a contact lens package in
an unopened
.. state according to an embodiment.
FIG. 6 illustrates air entry guides of a contact lens package according to an
embodiment.
FIGS. 7A and 7B illustrate a lens support of an embodiment in a side and top
view,
respectively.
FIGS. 8A and 8B illustrate a lens support of an alternative embodiment in a
side and top
view, respectively.
FIG. 9 illustrates contact lens packages of an embodiment in a nested
configuration.
FIG. 10 illustrates exemplary methods of manufacture of a contact lens package
according
to certain embodiments.
V. 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
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Date Regue/Date Received 2022-09-08
feature, structure, aspect, or characteristic, but every embodiment may not
necessarily include
the particular feature, structure, or characteristic. Moreover, such phrases
are not necessarily
referring to the same embodiment. Further, when a particular feature,
structure, aspect, or
characteristic is described in connection with an embodiment, it is submitted
that it is within the
knowledge of one skilled in the art to effect such feature, structure, or
characteristic in
connection with other embodiments whether or not explicitly described.
As used herein, the following terms have the following meaning. A benefit of
the certain
embodiments the present invention is that they facilitate consistent single-
touch lens transfer
from the package to a wearer's finger, and then from the finger to the
wearer's eye without the
__ lens inverting, falling off the finger or further manipulation. Consistent
lens transfer includes a
transfer rate of at least about 70%, at least about 80% or at least about 90%
transfer on the first
touch of the finger (or "dab"). The lens also desirably "sits up" on the
finger without collapsing
or inverting and then transfers to the eye when placed there. Packages of
certain embodiments
may provide the desired single-touch transfer across a range of finger sizes,
and dab pressures.
Environmental conditions such as the temperature and whether the finger is wet
or dry may also
impact transfer rate, with higher temperatures generally improving lens
transfer.
Lens(es) or contact lens(es) refer to ophthalmic devices that reside on the
eye. They have
a generally hemispheric shape and can provide optical correction, cosmetic
enhancement, UV
blocking and visible light or glare reduction, therapeutic effect, including
wound healing, delivery
of drugs or neutraceuticals, diagnostic evaluation or monitoring, or any
combination thereof. The
term lens includes soft hydrogel contact lenses, which are generally provided
to the consumer in
a package in the hydrated state, and have a relatively low moduli, which
allows them to conform
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Date Regue/Date Received 2022-09-08
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, lotrafi Icon 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,
fa nfilcon, formofilcon, galyfilcon, lotrafilcon,
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Date Regue/Date Received 2022-09-08
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
Date Regue/Date Received 2022-09-08
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. Wetted contact is the aggregated contact area
between the wetted
lens and lens support.
Embodiments may include a lens support surrounded by a sealable cavity also
interchangeably referred to as a chamber. The cavity may have any convenient
form and may
comprise a package base and at least a lid, each of which are described in
detail below. As used
herein, the phrases "the lid", "a lid", "the base" and "a base" encompass both
the singular and
plural. The lid and package base are sealed to each other to form a cavity
which holds the contact
lens, support and packaging solution in a sterile state during shipping and
storage prior to use.
The contact lens package is made from materials which are compatible with the
contact lens and
solution, as well as retortable and biologically inert.
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Date Regue/Date Received 2022-09-08
"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.
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Date Regue/Date Received 2022-09-08
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,
nutraceutica Is, pharmaceuticals, in package coating components and the like.
The package base may form the bottom of the package. It can be made from any
material
suitable for packaging medical devices, including plastic. The packaging lid
generally resides at
the upper portion the package and seals with the base to form a cavity
containing at least a
portion of the lens support, lens, and packaging solution. The lid may be made
from any material
suitable for packaging medical devices, including a molded sheet of foil or
plastic, laminate films,
or plastic. Packages comprising plastic for one structure and foil or
laminated films as the other,
or packages comprising foil or laminated films as the outer layer for the lid
and base are known
in the art and are examples of suitable combinations.
References throughout this description to injection molding processes and the
use of
materials conventionally applied to injection molding should be understood as
exemplary. Those
of skill in the art will appreciate that other means of manufacture are
possible within the scope
of the appended claims, including but not limited to alternative molding
processes,
thermoforming, 3D printing, and the like. Likewise, references to heat seals
and heat sealing are
exemplary to embodiments described herein. Other means of securing packaging
components
will be apparent to those skilled in the art, including the use of adhesive,
glue, thermal bonding,
welding such as heat, ultrasonic or laser welding, or a mechanical trap, and
the like.
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Date Regue/Date Received 2022-09-08
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 0.08p.m.
With reference to the figures, FIGS. 1A-1D illustrate steps of handling a
contact lens
package containing a contact lens in packaging solution 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 can hinge when force is applied to the
lever 118.
Base 110 further includes several optional finger engagement features 122a-
122c to assist
the user with handling the contact lens package during the opening process. A
finger dimple
122a may be sized to accommodate a finger or thumb of the user is disposed at
the end of the
base 110 proximal to the user; an overhang 122b along a peripheral edge of the
base 110; and a
protrusion 122c is disposed at the end of package 118 distal to the user.
Finger dimple 122a in
this embodiment is also angled downward such that a force, e.g., pressure
applied by a thumb of
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Date Regue/Date Received 2022-09-08
the user, causes the lever 118 to hinge downward at the pivot line 114.
Package 100 in this
embodiment is further configured with a profile that slopes from proximal to
distal end to further
encourage a downward moment at the lever, for example when the lever is
pressed down or the
when the package is squeezed by the user, i.e., when the user applies pressure
by hand at
opposing ends of the package, i.e., via a finger at one end and a thumb at the
other. In this
embodiment, package 100 is configured such that the squeezing forces are
applied at the distal
and proximal ends. However, alternative embodiments are possible whereby the
opposing
forces involved in squeezing are applied at alternative opposing ends of the
package, such as but
not limited to the sides, left and right, of the package.
In a first step shown in FIG. 1B, a user holds an unopened contact lens
package 100 by its
base 110. As illustrated, a user's grip upon the package 100 may be improved
by one or more
finger engagement features 122a-c 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 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 and against a
protrusion 122c
at the end of the base 110. In the case of an overhang, the overhanging region
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
Date Regue/Date Received 2022-09-08
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 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 suspended 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
force upon lever 118.
Turning to FIG. 1D, the force applied to the lever by the user causes 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 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 an
angle of lift of
between about 15 to 60 relative to the horizontal plane that defines the top
of the base when
force is applied by the user. 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
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
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Date Regue/Date Received 2022-09-08
"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 step
illustrated, with the convex side of contact lens 138 against the finger 154
and the concave side
of the lens 138 oriented for direct application to the user's eye surface.
Turning now to 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).
At its 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 118. More specifically, base 110, including lever 118,
is formed as a
17
Date Regue/Date Received 2022-09-08
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
(Tg) 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
multiple voids 158 in the base. Voids 158 are positioned in a linear
configuration along a
horizontal axis at a point along which it lever 118 hinges. The absence of
material that creates
voids 158 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
distance of the lifting arm,
i.e., the distance from the pivot line to the center of the contact lens when
resting on the support
is between about 10-12mm, and preferably between 12-17mm. The use of one or
more voids 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.
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 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
18
Date Regue/Date Received 2022-09-08
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 (as described further with reference to FIG. 9) 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 142 and has a footprint of approximately 29mm in width, 44mm in
length, and
9.5mm in height. Preferred slopes have a range of between about 10-202, but
the slope may be
made even steeper, e.g., about 20-302, 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 2240p.1,
which is dosed with approximately 20804 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
19
Date Regue/Date Received 2022-09-08
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 4.5mm when measured from the
seal level to
the base of the dimple.
A lens support 140 is coupled to the lever 118 so that force applied to the
lever 118 causes
the lens support 140 to lift the contact lens 138 out of the packaging
solution. In the embodiment
illustrated, lens support 140 is a separately molded (or printed) component
that is fixedly
attached to the lever 118 portion of the base. Attachment is made here via a
stake 162 formed
in the lever portion of the base material. Lens support 140 has an opening 166
corresponding to
the stake 162 so that, when lens support 140 is placed onto the base, stake
162 mates with
opening 166. Heat is applied using a hot plate to the stake/opening to deform
the plastic material
using heat and force, holding the stake securely in position like a rivet. A
bond is made by partially
deforming the stake 162 around opening 166. Numerous other means of attachment
other than
heat staking are possible within the scope of the claims, including e.g.,
laser welding, ultrasonic
welding, adhesion, mechanical clipping, and the like. Further, it should be
noted that in
alternative embodiments in which the lens support may be formed as part of the
same unitary
molded or printed component as the lever and/or the entire base.
The point of
coupling/attachment of the lens support to the lever is preferably about 2 to
5mm from the pivot
line to the front of the peg/stake. In many embodiments, such as the one
illustrated in which the
pivot line is formed by a fold in plastic or other substantially rigid
material, the pivot line may
have a thickness, i.e., it may not be perfectly sharp. In these cases, such
separation may be
Date Regue/Date Received 2022-09-08
needed between the point of attachment and the pivot line in order to maximize
the lifting angle
for a given bend force.
The underside of a lid 106, as can be seen in FIG 2., includes multiple lens
facing surfaces
168, which in this embodiment are formed as projections extending downward
toward the lens's
convex surface. 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 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. 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
these forces to avoid or reduce significant optical damage. For example,
gravitational forces and
interactions with air bubbles in the packaging solution can result in optical
damage if not properly
counteracted. In one aspect, lens facing surfaces, as in the lens facing
surfaces 168 of the
illustrated embodiment, include a relatively large contactable surface area,
at least about 3
percent and preferably at least about 20% of percent or as large as possible
while still
21
Date Regue/Date Received 2022-09-08
accommodating any desired air egress channels. The contactable surface area is
understood to
mean the area of contact between the lens and lens facing surfaces when the
lens is loaded, i.e.,
placed into contact under an applied force, such as but not limited to gravity
or air bubble
interaction. The contactable surface area determines the pressure exerted on
regions of the lens
when/if it is loaded. The larger the area, the more the pressure is reduced.
In the embodiment
illustrated, the lens facing surfaces 168 have a contactable surface area of
100 mm' conventional
contact lens having a surface area of approximately 215mm2. As discussed in
more detail below,
it is preferable that at least 10% of the surface area above the lens be left
exposed to promote
air entering the package to travel over to reduce any tendency of the lens to
stick to the lens
facing surfaces/lid insert.
The lens facing surfaces 168 are also spaced apart to define air egress
channels 169 allow
air, in particular air bubbles in the packaging solution, to travel away from
the contact lens into
a peripheral volume of the cavity 136. It is advantageous for the air egress
channels have a
positive gradient toward the peripheral volume with a vertical rise of at
least about 2mm. 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 1mm-1.5mm or preferably between 1.5mm-2mm and, specifically 1.5mm in the
embodiment illustrated. In a related aspect, air egress channels 169
advantageously form an
configuration. This configuration of air egress channel positions relative to
each other allows,
when the package is rotated in a side orientation, at least one of the
channels always to have a
central axis from near the center of the cavity that is angled relative a
plane normal to gravity.
22
Date Regue/Date Received 2022-09-08
This aspect exploits buoyancy to allow air bubbles to escape away from lens
irrespective of the
orientation the lens package take thus reducing the optical damage that might
otherwise result,
e.g., from the air bubble forcing the lens into the lens support.
Lid insert 170 is attached to an inner surface of the lid 106 in this
embodiment by a heat
seal between the multi layer film lid 106 and the planar surfaces 172a-d on
the upper side of the
lid insert. As discussed in more detail later herein, alignment of a lid
insert with the base during
the heat-sealing process and during storage may be aided by the inclusion of
one or more
alignment features in the base and/or lid insert. For example, alignment
features 174 in the
embodiment illustrated take the form of columns on the interior wall of cavity
136 of the base
110. The alignment features 174 resist rotation and lateral motion of the lid
insert 170 when
pressure is applied to seal the package 100 or during normal use. Alternative
alignment features
are possible such as but not limited to forming the cavity and lid insert (or
integral portion of the
lid comprising lens facing surfaces) in a non-circular shape such that the
components interlock
and resist rotation inherently.
Referring now to FIG. 4, illustrated is a close-up view of a lid insert 170
when inserted in
cavity 132 of base 110. The position of alignment features (e.g., columns 174)
on the wall of
cavity 136 of the base 110 correspond to openings 178 in lid insert 170.
Columns 174 and
openings 178 cooperate as an assembly to restrict rotational and lateral
movement of the lid
insert 170. In another aspect, the lid insert may be configured 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 sealing pressure is
applied or during
storage, transport, or when the user opens the package. For example, a lock-
out feature may be
23
Date Regue/Date Received 2022-09-08
included to prevent lid features, such as lens facing surfaces (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. Further still, another lock-out feature in this embodiment is created
by a ledge 180 along
the perimeter of the floor of cavity 136. 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. In this embodiment, the ledge measures
approximately 0.8
mm in height above the base of the lens. It should be understood that a 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).
FIGS. 5A and 5B illustrate a cross-sectional view of a contact lens package
100 in an
unopened state. Specifically, FIG. 5B illustrates the cross-section created
across section plane AA
indicated in the perspective side view in FIG. 5A. As shown, package 100 is
configured such that
when in an unopened state, contact lens 138 is substantially suspended 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 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
24
Date Regue/Date Received 2022-09-08
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. However, the optical zone of the
contact lens 138 is
effectively suspended between the lens support 140 and the lens facing
surfaces 168.
Cavity 132 preferably is substantially filled with packaging solution,
provided however
that manufacturing processes may not permit sealing the packaging under vacuum
pressure. In
such cases, it is anticipated that some amount of air will become entrapped in
the cavity. If these
air bubbles are not managed, they may interact with the lens and cause
significant optical
damage to the lens. Accordingly, peripheral volumes in the cavity, i.e.,
volumes in the cavity that
are peripheral to the location of the lens over the lens support, may be
provided. Ideally, such
volumes should be provided at the distal and proximal ends of the package,
such as 132' and
132" of cavity 132 of package 100, so that the air bubbles have a place to
reside regardless of the
orientation of the package during transport or storage.
In one aspect, lens facing surfaces may function as air entry guides through
placement
and configuration that causes air that enters the package upon opening to
travel over the contact
lens to avoid the contact lens sticking to the lid or lens facing surfaces
thereof. As illustrated in
FIG. 6, contact lens package 100 is depicted in an assembled, unopened state
in which the foil lid
is not shown so that the components as sited within package 100 may be seen in
this
embodiment, the package 100 is configured to be opened from proximal end (A)
to distal end (B)
such that air enters the package in the direction indicated by arrow 190. To
ensure that air travels
over the lens, lid insert 170 is configured so that the convex surface of the
lens 138 is exposed
above the lens edge closest to the point 192 that air enters the cavity upon
opening. This may
Date Regue/Date Received 2022-09-08
be achieved by positioning the lens facing surfaces predominantly over the
lateral and distal
surface areas of the contact lens and leaving exposed at least about 10% the
surface area of the
contact lens nearest point 192 where air enters the cavity. More specifically,
in this embodiment,
15% of the contact lens's surface area is left exposed.
Lens supports of the present invention may take myriad shapes and forms
capable of
lifting the lens out of the packaging solution when the user applies force(s)
to the package, such
as squeezing the package as described with respect to embodiments herein.
However, as
mentioned it is preferable that the lens support keeps the lens in the desired
convex orientation
(bowl down relative to the base) and position (centered over the support)
during shipping and
storage. Ideally, the lens support may provide an open structure under the
lens to allow, upon
opening, the packaging solution to drain from the lens and support without
trapping water
between the support and the underside of the lens. It is also preferable that
the lens support
has a sufficient number of contact points with the lens to prevent the lens
from collapsing onto,
rotating off or translating across the support. This allows the apex of the
lens to be supported
by the lens's own elastic stiffness, or to minimize sinking of the lens apex
while limiting the
contact area between the support and lens. Too much contact between the
support and the lens
after solution draining, and water trapped between the support and the lens,
can create surface
tension between the lens and water on and around the lens support that is
greater than the
surface tension between a wearer's finger and the lens, interfering with
efficient lens transfer.
The sum of the contact between the lens and the lens support when the package
is open, and
the solution drained from the lens and lens support is the total wetted
contact area, which may
be less than about 30 mm2, less than 25mm2 or less than 20mm2 and is
distributed at least around
26
Date Regue/Date Received 2022-09-08
the lens periphery, as described herein. "Wetted contact area" as used herein
refers to the direct
solid contact area between the lens support and the lens added to the area of
any menisci,
reservoirs, or solution bridges that form between the lens and lens after the
lens is lifted and
packaging solution is allowed to drain for less than about <30s, less than
about <5s, or less than
about 2s, depending on the intended user experience of the package.
For lenses made from polymers with longer shape memory, the lens support may
be
designed to limit contact between the lens and support during storage. Such
contact may be
distributed around the lens peripheral edge. Contact between the lens optic
zone, lens support
and lid interior (including any air entry guides) may be transitory or there
may be no contact
between the optic zone and support, lid or air entry guides. Lenses, such as
conventional
hydrogels, having shorter shape memory, are less prone to distortion from
packaging contact,
and can have the contact points distributed around the periphery and
throughout the lens
profile, including the lens center zone (about 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.
27
Date Regue/Date Received 2022-09-08
The lens support preferably provides at least 2, at least 3, 3 to 14, 4 to 14,
3 to 8 or 4 to
8, 4 to 6 or 6 points of contact with the contact lens edge along the
peripheral supports. When
two peripheral supports are used, they may be wider to provide stability,
without exceeding the
area of contact desired for consistent lens transfer. The peripheral points of
contact prevent the
lens from rotating off the lens and can be distributed in a number of
configurations, in which the
space between the furthest adjacent contacts is less than the diameter of the
lens. As the
number of peripheral supports is increased the likelihood of residual
packaging solution forming
films between adjacent peripheral supports and solution bridging between the
support and lens
may be increased during drainage. Peripheral supports with less than 50% open
space such as
those in the form of a screen or strainer, generally provide insufficient
drainage to insure one
touch transfer. Likewise, too much contact between the support and the lens
after solution
draining, and water trapped between the support and the lens, can create
surface tension
between the lens and water on and around the lens support that is greater than
the surface
tension between a wearer's finger and the lens, interfering with efficient
lens transfer. The width
of the constituent support members of the lens support vary between the limits
of the selected
molding process and widths necessary for efficient packaging solution drainage
upon opening.
Suitable widths include about 0.5 to about 1.5mm, 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 on the lens
28
Date Regue/Date Received 2022-09-08
support of channel members along which packaging solution is channeled away
from the lens
under the force of gravity when the lens support is lifted. Back drainage, on
the other hand,
refers to enhanced drainage from the underside of the lens where the lens
rests on the lens
support. This area underneath the apex of the lens tends to trap packaging
solution due to the
hydrophilicity of modern contact lens materials. Enhanced back drainage may be
achieved in
some embodiments by designing the lens support with a central opening beneath
the apex of
the lens of at least about 12mm3.
Referring then to FIGS. 7A and 7B, 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
central support
composed of three central support members 200a-c in a semi-circular
configuration having a
diameter of approximately 8mm. Central support members 200a-c are elevated 2.5
mm by
pillars 204. Pillars 204 extend upward from channel members 204a and 204b,
which transition
along their length from proximal end (A) to distal end (B) to form a channel
formation into a
peripheral support 208. These members cooperate so that when the contact lens
is lifted from
the package, it rests upon lens support 240 in the preferred convex
orientation (bowl down
relative to the base of the package) at 7 contact points when the lens is
lifted from the packaging
solution.
The design of lens support 140 creates central opening 212 to allow the
packaging
solution to back drain from the lens and lens support 140 when the package is
opened and the
lens support lifted from the packaging solution. This allows the apex of the
lens to be supported
29
Date Regue/Date Received 2022-09-08
by the lens's own elastic stiffness, and to minimize sinking of the lens apex
while limiting the
contact area between the support 140 and lens. The design also provides
sufficient support to
edge of the contact less at points along the channel members 204a and 204b as
well as along
peripheral support 208. This configuration sufficiently reduces the wetted
contact area between
the lens support 140 and the contact lens to at least about 25 mm2 when
measured 2 seconds
after lens support 140 is lifted.
One of myriad alternative embodiments of a lens support within the scope of
the
invention is shown at FIGS. 8A and 8B illustrate in a side and a top view,
respectively. Lens
support 300 represents an example of a lens support that relies upon back
drainage to clear
.. packaging solution from the lens sufficiently to enable single-touch
transfer. Lens support 300
includes a central support 310 composed of four equally spaced radial spokes
extending across a
diameter of approximately 10.5 mm. Central support members 310 is elevated 2.7
mm by pillars
314. Pillars 314 extend upward from support member 318, which includes a tab
324 by which
the lens support 300 may be coupled to a base of a contact lens package in
certain embodiments
of the invention. Peripheral support members 328 and 330 are formed in a
continuous bow-tie
configuration to provide support to the edges of a contact lens when the lens
is lifted from the
package and resting upon the support. The central and peripheral support
members of support
300 cooperate so that when the contact lens is lifted from the package, it
rests upon lens support
300 in the preferred convex orientation (bowl down relative to the base of the
package) at 5
contact points when the lens is lifted from the packaging solution.
The design of lens support 300 includes sufficient open space between the
spokes of
central support 310 to allow the packaging solution to back drain from the
lens and lens support
Date Regue/Date Received 2022-09-08
140 when the package is opened and the lens support lifted from the packaging
solution. This
allows the apex of the lens to be supported by the lens's own elastic
stiffness, and to minimize
sinking of the lens apex while limiting the contact area between the support
300 and lens. The
design also provides sufficient support to the edge of the contact lens at
points along the
peripheral support members 328 and 330. This configuration sufficiently
reduces the wetted
contact area between the lens support 300 and the contact lens to at least
about 25mm2 when
measured 2 seconds after lens support 300 is lifted. It must be emphasized
that the lens support
embodiments illustrated and described herein are merely two among of myriad
embodiments of
a lens support within the scope of the invention as set forth in the appended
claims. To be sure,
a number of additional illustrative but non-limiting exemplary lens supports
are depicted in
Appendix A.
As noted above, in one aspect contact lens packages of the present invention
may be
configured to allow a nested configuration. FIG. 9 illustrates two of contact
lens package 100
shown as packages 100' and 100" in a nested configuration. A nested
configuration, such as the
one depicted in which the packages fit together securely within a smaller
volume are useful for
reducing the amount of secondary packaging (e.g., carton or other container in
which the primary
packages are provided to the consumer). In this embodiment, packages 100' and
100' are
designed to nest when arranged base-to-base and inverted relative to each
other from proximal
end to distal end. The ability of contact lens packages 100' and 100" to nest
is enabled by a
combination of features including: a taper in the base 110' and 110" of each
package and finger
engagement features (dimples) 122a' and 122a" functioning as stops against
lateral movement
of the bases 110' and 110".
31
Date Regue/Date Received 2022-09-08
Turning now to FIG. 10 are illustrated exemplary methods of
manufacture/assembly of a
contact lens package in accordance with an embodiment. A first exemplary
method of
manufacture/assembly of the exemplary contact lens package 100 is illustrated
as steps 1001A,
1002A, 1003A, 1004A, and 1005. At a first step 1001A, a contact lens 138 is
placed onto lens
support 140 in this embodiment with the contact lens being placed onto the
lens support 140
with its concave side of the contact lens onto the lens support. The lens
support may be pre-
dosed with packaging solution sufficient to cause the contact lens to bind to
the support. In a
slightly alternative approach not illustrated, the lens support may be
inserted into the cavity first
and the contact lens placed on the support thereafter. At a next step 1002A,
lens support 140
with the contact lens 130 resting thereon is inserted into cavity 136 of a
base 110. Then, at step
1003, lid insert 170 comprising lens facing surfaces 168 is placed onto the
convex side of the
contact lens 138. Next, at step 1003A, the cavity is dosed with packaging
solution sufficiently to
fully submerge contact lens 138 in the cavity and ideally as full as possible
without overflowing
the cavity. Preferably, at least one of the fitment and/or a surface feature
of the lid insert against
the base cavity creates a friction fit so that the lid insert does not float
out of position when the
packing solution is added to the cavity. Finally, at a step 1005, the lid 106
is sealed onto the base
110, for example by heat sealing the foil to the base as described in more
detail above, such that
the sealing encloses the contact lens 138 and packaging solution within the
cavity 136 in a sterile
environment.
An alternative exemplary method of manufacture/assembly of the exemplary
contact
lens package 100 is illustrated as steps 1001B, 10028, 10038, 10048, and 1005.
At a first step
1001B, a package base 110 is provided wherein a cavity 136 of the base 110 has
lens support 140
32
Date Regue/Date Received 2022-09-08
coupled thereto. In this example, lens support 140 is coupled to the base by a
heat staking
process as described in more detail above. However, as noted, other means of
attachment are
possible within the scope of the claims, including e.g., laser welding,
ultrasonic welding, adhesion,
mechanical clipping, and the like. Next at a step 1002B, a contact lens 138 is
placed onto a lens
facing surface of a lid insert 170, in this embodiment with the lens's convex
surface resting against
the lens facing surfaces 168 of lid insert 170. The lens 138 may be placed
onto the lid insert by
manual or automated means such as through a lens transfer nozzle. Then, at a
step 1003B, the
lid insert 170 having the contact lens 138 resting thereon is placed onto the
lens support 140 in
the cavity 136 of the base 110. Next, at a step 1004B, the cavity 136 is dosed
with packaging
solution sufficiently to fully submerge the contact lens 138 in the 136 cavity
and ideally as full as
possible without overflowing the cavity. Finally, at a step 1005, the lid 106
is sealed onto the
base 110, for example by heat sealing the foil to the base as described in
more detail above, such
that the sealing encloses the contact lens 138 and packaging solution within
the cavity 136 in a
sterile environment.
In some methods of manufacture/assembly of contact lens packages within the
scope of
the invention, the provision of packaging solution to the cavity may take
place in multiple doses
at different steps of the assembly process as opposed to all at once as
described in the exemplary
methods above. For example, in embodiments in which the lens is placed upon
the lens support
(e.g., step 1001A above) it may be advantageous to pre-dose a small amount of
packaging
solution onto lens support before resting the lens thereon so that the lens
becomes secured to
the lens under the surface tension of the solution. Dividing the dosing of
packaging solution may
also be advantageous when filling the cavity, such as, for example, by
dividing a dose of
33
Date Regue/Date Received 2022-09-08
approximately 20804 into two approximately equal sized doses for example at
steps (1001B and
1004B) described above.
The foregoing description, for purposes of explanation, used specific
nomenclature to
provide a thorough understanding of the described embodiments. However, it
will be apparent
to one skilled in the art that many of the specific details are not required
in order to practice the
described embodiments. Thus, the foregoing descriptions of the specific
embodiments described
herein are presented for the purposes of illustration and description. They
are not targeted to
be exhaustive or to limit the embodiments to the precise forms disclosed. It
will be apparent to
one of ordinary skill in the art that many modifications and variations are
possible in view of the
above teachings.
The Summary and Abstract sections may set forth one or more but not all
exemplary
embodiments of the present invention as contemplated by the inventors, and
thus, are not
intended to limit the present invention and the appended claims in any way.
The foregoing description of the specific embodiments will so fully reveal the
general
nature of the invention that others can, by applying knowledge within the
skill of the art, readily
modify and/or adapt for various applications such specific embodiments,
without undue
experimentation, without departing from the general concept of the present
invention.
Therefore, such adaptations and modifications are intended to be within the
meaning and range
of equivalents of the disclosed embodiments, based on the teaching and
guidance presented
herein. It is to be understood that the phraseology or terminology herein is
for the purpose of
description and not of limitation, such that the terminology or phraseology of
the present
specification is to be interpreted by the skilled artisan in light of the
teachings and guidance.
34
Date Regue/Date Received 2022-09-08
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.
Date Regue/Date Received 2022-09-08
