Note: Descriptions are shown in the official language in which they were submitted.
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SINGLE TOUCH CONTACT LENS PACKAGE
Background of the Invention
Over the years, it has been a common perception that it would be ideal to
provide
users 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 (as is currently common)
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 user's
other fingers as the lens is being prepared for orientation and insertion onto
the eye,
and 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 user
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 have their own unique surface, bulk and geometric properties. Finger size
and the
force a contact lens wearer imparts on the lens during transfer can also vary.
These
factors can impact the process for taking the lens from the package onto the
finger and
then onto surface of the eye. Among other considerations: it would be
desirable for
users to be able to drain away any 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. 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.
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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 user 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:
= The package ideally should protect lens. It should ensure the lens's
integrity, while at the same time prevent crushing or damage to the lens.
= The lens package should maintain the hydration of the lens when stored.
This will maintain the lens's properties. The lens in its package 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 to
the wearer's finger. The package must have a retortable seal and contain
both the lens and solution.
= The package preferably should maintain the lens in the desired convex
orientation to the wearer. The lens should be correctly positioned on the
lens support so that it can be easily removed by the user.
= The package should allow the packaging solution to be effectively drained
away from the lens upon opening of the packaging and prior to lens
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removal, to enable easier transfer to the wearer's finger and then onto the
eye.
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.
US20190046353 discloses contact lens storage containers that facilitates an
increased ease of lens removal. However, the package requires the user to pour
out
the packaging solution and does not provide the desired consistent one touch
removal.
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.
Thus, there remains a need for contact lens packages which provide a
consistent
one touch lens removal experience.
Summary of the Invention
The present invention provides a contact lens package whereby the lens is
placed over a lens support composed of a suitable material which will enable
functionality of the package while meeting all the other standard packaging
requirements, such as appropriate strength, sterilizability and ease of
opening. The
package is filled with saline solution so that the lens remains hydrated
during shipping
and storage. When the package is in a closed position, such as during storage
or
transport, the lens and lens support is covered by a base on the bottom and a
lid on the
top, which function as a protective cover or outer shell (in addition to the
other functions
described herein). The lid is configured with a geometry so that upon opening
the
package a volume of air enters the package cavity beneath the lid and on top
of the
convex side of the lens. The influx of air prevents a suction force occurring
between the
lens and the lid and causes the lens to remain on the lens support with the
lens concave
surface down. The draining of the solution from the package causes the lens to
lose
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surface tension with the lens support surface. When in this position, the lens
can be
then adhered by transferal to user's finger, as the finger exerts a greater
suction force
due to surface tension than that exerted by the lens support on the lens.
Thus, the lens
is now maintained on the user's finger from the convex side of the lens and
the user can
transfer the concave side of the lens onto the eye surface. In
contradistinction to
present methods of applying contact lenses, in one motion the user can take
the lens
from the package and place it on the eye.
The present invention relates to a contact lens package comprising
a support for maintaining a contact lens in a convex position on the support
during storage and upon opening the package; wherein
the lens has a peripheral edge and a lens profile;
the support has a profile that does not substantially match the lens profile;
and
wetted contact between the support and the lens is less than about 20 mm2,
less than
18mm2 or less than 15 mm2.
The present invention further relates to a contact lens package comprising
a package base;
a package lid; and
a support for holding, in a convex position relative to the package base, a
contact
lens having a peripheral edge and a lens profile;
wherein the base and lid are sealed to form a cavity comprising the support,
contact lens and packaging solution;
wherein the lens support comprises a plurality of peripheral supports which
have
a distal end extending at least 1 mm beyond the contact lens peripheral edge
and
provide at least 3, 3 to 14, 4 to 14, 3 to 8 or 4 to 8, 4 to 6 or 6 points of
contact with the
contact lens edge along the peripheral supports and wetted contact between the
support and the lens after the package has been opened and the packaging
solution
has been directed away from the lens and support, is less than about 20 mm2,
less than
18mm2 or less than 15 mm2.
The present invention further relates to a contact lens package comprising
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a support for holding, in a convex position relative to the support, a contact
lens
having a convex surface; and
a lens facing surface comprising at least one air entry guide configured such
that,
upon opening the package by a user, the at least one air entry guide guides
air entering
the package over the contact lens convex surface to reduce the incidence of
the lens
sticking to the interior surface.
Detailed Description of the Drawings
The present invention will be better understood from the appended drawings, in
which:
Figures 1A-0 are drawings of various lens support configurations.
Figures 2A is a drawing of a contact fens package base of the present
invention.
Figure 2B is a drawing of a contact lens package base and lid of the present
invention.
Figures 3A-H are drawings of lids showing examples of air flow management
features of within present invention.
Figures 4A and B are drawings showing examples of air capture features within
the present invention.
Figures 5A and B are drawings showing contact lens packages within the present
invention.
Figure 6 is a graph of contact lens RMS values as a function of package fill
volumes.
Figure 7 is a drawing of the interior of a package lid.
Detailed Description of the Invention
The present invention relates to packages for contact lenses, such as hydrogel
contact lenses that permit the user to remove the contact lens from the
package with
the touch of a fingertip at or near the apex of the contact lens. The lens
once
transferred to the fingertip is in a position suitable for placement by the
wearer on the
eye, thereby simplifying lens removal from the package and insertion on the
eye.
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As used herein, the following terms have the foregoing meaning.
A benefit of the lens packages of the present invention is that they provide
consistent one-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 the present invention may
provide the desired one-touch transfer across a range of finger sizes, and dab
pressures. Environmental conditions such as the temperature and whether the
finger is
wet or dry may also impact transfer rate, with higher temperatures generally
improving
lens transfer. Lens transfers evaluated in the present invention were
conducted at room
temperature.
Contact lenses refers to ophthalmic devices that reside on the eye. They have
a
generally hemispheric shape and can provide optical correction, cosmetic
enhancement, UV blocking and visible light or glare reduction, therapeutic
effect,
including wound healing, delivery of drugs or neutraceuticals, diagnostic
evaluation or
monitoring, or any combination thereof. The term lens includes soft hydrogel
contact
lenses, which are generally provided to the consumer in a 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
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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 polyrnacon, 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,
forrnofilcon, 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, 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. Silicon 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
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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 of the lens is the center of the lens optic zone. The optic zone
provides optical correction and may have a diameter between about 7 and about
10
mm. The lens 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.
The contact lens package comprises a lens support surrounded by a reversible
sealable chamber. The chamber may have any convenient form and may comprise
package base which may have one or multiple compartments or base segments,
lens
support and at least one lid, each of which are described in detail below. 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
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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 PAC coatings to improve
barrier
resistance to oxygen or moisture vapor.
Packaging solution is any physiological solution 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 forms the bottom of the package. It can be made from any
material suitable for packaging medical devices, including a flat sheet of
foil or plastic, a
laminate film, or plastic. The bottom of the lens support is disposed on and
supported
by the base surface facing into the package cavity. The lens support may also
be
integral with the base. The lens support may rest on the inner surface of the
package
base which may be horizontal or may be angled to maintain the lens support and
lens in
an angled position when the bottom of the base is horizontal. When the base is
disposed at an angle, the angle is preferably at least about 15 , at least
about 20 ,
about 200 to about 80 , about 20 to about 60 or about 20 to about 40
relative to
level.
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The packaging lid forms the uppermost structure of the package and seals with
the base to form a cavity containing the lens support, lens, packaging
solution and any
other incorporated packaging features. The lid may be made from any material
suitable
for packaging medical devices, including a flat or molded sheet of foil or
plastic,
laminate films, or plastic. 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 are known in the art and are examples of
suitable
combinations.
Lens Support & Transfer
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. The lens support is designed to provide an open structure under the
lens bowl
to allow, upon opening, the packaging solution to drain from the lens and
support
without trapping water between the support; and a sufficient number of contact
points
with the lens to prevent the lens from collapsing onto, rotating off or
translating across
the support. This allows the apex of the lens to be supported by the lens' own
elastic
stiffness, or to minimize sinking of the lens apex while limiting the contact
area between
the support and lens. 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
contact area, which may be less than about 20 mm2, less than 18mm2 or less
than 15
mm2and is distributed at least around the lens periphery, as described herein.
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
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Lenses, such as conventional hydrogels, having shorter shape memory, are less
prone
to distortion from packaging contact, and can have the contact points
distributed around
the periphery and throughout the lens profile, including the lens center zone
(about
9mm, or about 5 mm diameter).
The lens supports of the present invention allow, upon dabbing, both the
fingertip
and lens to deform to match each others 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 is to control the
ratio of the
contact area between the finger and lens as compared to the area between the
lens and
the lens support so that the contact area between the finger and lens exceeds
the
contact surface area of the lens support on the lens underside. This will
ensure that
surface tension between finger and lens exceeds surface tension between lens
and lens
support. Thus, the lens will adhere to the finger for lens transfer and
placement onto the
eye.
Figures 1A-P show examples of lens supports useful with the present invention.
Each of these lens supports may be useful with any of the packages described
herein.
The lens support may provide a light resistive force on the lens during lens
transfer to
allow the lens to be adhered to the finger. As shown by Figures 1A-P, the lens
support
may be designed in a range of configurations. It should be appreciated that
the
configurations depicted herein are illustrative examples. Configurations not
illustrated
or those that combine aspects of the exemplary configurations depicted are
possible
within the scope of the appended claims as will be apparent to those skilled
in the art in
view of the balance of this disclosure.
The lens support provides at least 2, at least 3, 3 to 14, 4 to 14, 3 to 8 or
4 to 8, 4
to 6 or 6 points of contact with the contact lens edge along the peripheral
supports 105.
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. In embodiments employing three contact points, the
contacts
may be arranged in an acute triangle as shown in Example 16. All (Figures 18,
C, H, K
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and L) or most (Figures 1M-0) of the peripheral supports can be evenly
distributed
around the lens periphery. 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.
Figure 1G shows a lens support comprising 6 planar peripheral supports 105
which join in the center of the lens support and extend outward to an
unsupported distal
end. Channel members 115 are one structure which may be used to help
facilitate
packaging solution drainage and are discussed in detail, below.
The peripheral supports 105 provide a path for packaging solution to drain
from
the lens when the package is opened. To facilitate drainage of the packaging
solution,
the peripheral supports are generally transverse to the lens edge, which helps
prevent
the lens from wrapping around the support, linear and may extend outward to a
distance
at least 1 mm beyond the contact lens peripheral edge. If the distal ends of
the
peripheral supports extend less than 2mm beyond the lens edge, packaging
solution
may be undesirably trapped under the lens, potentially interfering with
effective lens
transfer. If the central peripheral ends (such as the "V" notches of the
peripheral
support 105 in Figure 1D) are not connected to a center support, they may
extend in
toward the center of the support at least about 3mm from the contact point
with the lens,
as illustrated by the exemplary configuration of Figure 1D. If the peripheral
supports
extend less than 3mm from the lens contact point in toward the lens, the lens
may slide
off the peripheral support.
The peripheral supports 105 may be radially disposed around the center of the
support. They may attach to each other as shown in Figure 1G, or at an elbow
104 as
the terminal portion of a lens support arm as shown in Figures 1A and B.
Peripheral
supports 105 may extend inward from an at least partial peripheral ring 109 as
shown in
Figures 1C and 1D. And, peripheral supports 105 may connect to a central
column or
cylinder 107 as shown in Figure 1E, or any combination of the foregoing. When
the
peripheral supports extend inward, they may meet in a single central point
(Figure 1G),
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column, or cylinder 107 (Figure 1E). One or more of the peripheral supports
105 may
meet adjacent peripheral supports to form an open center as is shown in Figure
10.
Alternatively or additionally, one or more peripheral supports 105 may extend
inward
from their distal end at the at least partial peripheral ring to an
unsupported proximal
end inside the circumference of the lens or to another point on the peripheral
ring, as
shown in Figure 10. The peripheral supports may be planar, as in Figures 1B-G
or
may be angled as in Figure 1A. When angled, the angle may be from 0 to about
30 ,
or 00 to about 150 from level, and may slope toward the center of the support
or the
distal end of the peripheral support.
The distal end of adjacent peripheral supports 105 may connect to each other
via
terminal crosspieces which form a partial peripheral ring 109, as shown in
Figures 1B
and 1D or a full ring 109 as shown in Figure 10. For example, Figure 1D shows
a lens
support comprising a partial peripheral ring 109 with planar peripheral
supports 105 in
the form of an open, six-armed asterisk shape, radially disposed around the
center of
the lens support.
When a full or partial peripheral ring is included it may have a diameter at
least 4
mm larger than the contact lens (at least 2 mm from all contact lens edges) to
facilitate
drainage of the packaging solution away from the lens and lens support. For
partial
peripheral rings with complex shapes, such as the partial peripheral ring of
Figure 1D,
the diameter of the at least partial peripheral ring may be centered around
the center of
the lens support and is measured across opposite partial peripheral ring
sections 109.
Peripheral ring diameters of between about 16 and about 25 mm, about 18 and
about
25 mm or about 18 and about 24 mm will be suitable for commercially available
contact
lenses.
The peripheral ring, when included, may rest on the base during storage, may
be
fixedly attach to the base, or may attach to vertical supports such as feet,
stilts 110 as
shown in Figure 1K , a raised base fin section as shown in Figure IL, a
central column
or cylinder which keep it raised from the base. The vertical supports may
extend about
4 to about 5 mm from the base for a horizontally disposed lens support, or
about 2 to
about 5mm, about 2.5 to about 5mm or about 3 to about 4mm for a lens support
which
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is tilted when the package is closed, such as the tilted lens support depicted
in Figure
1H . When included, the vertical supports may be of the same length or may be
of
different lengths to maintain the lens at an angle relative to level. The
upper limit of the
height of vertical supports is limited by the desired size of the package, as
increasing
the length of the vertical supports increases the height of the overall
package and the
amount of solution required. A peripheral ring may also attach to a lifting or
pivot
structure, such as a lever or an extended channel member, described below, to
facilitate
raising the lens support from the base, to help drain packaging solution away
from the
lens.
The package base may also be designed such that the peripheral supports 105
(shown as part of a raised fin in the example embodiment of Figure 1H) are
level with
each other, but the base floor 120 and lens support 136 are disposed at an
angle
(Figure 1H). The tens support may be a separate structure or may be part of
the base
as shown in Figure 1H.
The lens support may further comprise at least one positioning structure (not
shown) to prevent the lens from translating horizontally across the lens
support,
particularly for supports disposed at an angle in the package or upon opening
and
removal. These positioning structures may include notches, prongs or stops
along the
peripheral support outside the lens periphery, an open central support
(described
below), positioning pins or tabs inside the lens near the periphery of the
lens, where the
lens surface is more steeply angled, such as located outside the central zone
of the lens
(diameter of about 5 mm, about 6 mm, or about 7 mm), or a combination thereof.
As shown in Figures 1E, 1J and 1H, the lens support may further comprise an
open structured central support to provide additional resistance, drainage
pathways
and/or to increase the contact area between the finger and the lens during
lens transfer.
The profile of the central support may be designed to keep the lens in the
convex
position preferably centered on the support during shipping and storage
without
significant contact, and provide the desired lens contact area after drainage
and prior to
contact by the user's finger. The central support may be configured such that
a gap is
created between the lens support and the lens, such as by having a
substantially flat top
that allows the top of the lens to be deformed by the finger and the finger
pad to be
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flattened, creating the desired bias in surface area. When present, the
central support
may be flat or may be slightly concave, preferably provides at least 0.5 mm
between the
lens apex and the top of central support upon draining (to minimize contact
between the
lens apex and the support) and provides a lens-finger contact area greater
than the
contact area between the lens and the rest of the lens support ("substantially
flat top" or
"fiat top"). If slightly curved, the central support may have a slightly
concave curve with
a radius of curvature of at least about lOmm or at least about 6 mm, or less
desirably a
slightly convex curvature of about 10 mm or higher. It may be desirable to
design the
central support so that it does not contact the lens optical zone until lens
transfer.
The top of the central support may have a diameter of about 1 mm to about 10
mm, about 3 mm to about 9 mm, about 5 to about 9 mm, or about 6 about 9 mm.
For
central supports having flat top regions with diameters less than about 5 mm,
additional
positioning structures may be desirable. The central support top may be
oriented
parallel to the lens periphery to form a column as shown in Figures 1A-1F. The
central
support top also provides resistance against the finder as the user presses
down on the
apex of the lens to initiate lens transfer.
The central support may be formed from a plurality of arms. The arms may form
a flat top section 101, and be supported by one or more columns 108 extending
up from
the base, as shown in Figure 1J; at least one peripheral support 105 as shown
in Figure
1A, B, C, E. F; at least one arm, as shown in Figure 1D; or vertical supports
110, in the
form of fins as shown in Figure 1H or open supports 110 as shown in Figure 1K.
When
the arms extend beyond the flat top, they may include an optional side section
103, a
shoulder transition 102 connecting the flat top 101 and optional side 103
sections,
peripheral supports 105, an optional elbow transition 104 connecting the
optional side
103 and peripheral support 105. The flat top section of the arms may connect
in the
center at point 106 as is shown in Figures 1A and 1B; a column 108 as in
Figure ii;
ring; or may connect to an open full or partial cylinder 107 as is shown in
Figure 1E, or
the arms may connect to the package base, either as solid fins with a void
106a in the
middle of the substantially flat top 101 (Figure 1H). The arms may also attach
to the
bottom of the lens support, as shown in Figure 1K, which has 6 arms with
curved side
sections 103, and a flat top section 101 formed by the upward facing ends of
the arms.
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The distal end of the peripheral support 105 may also be connected to
individual
supports from the base as shown in Figure 1K or directly to the base (Figure
IL).
As shown in Figures 1H and 1M the fins, base or both may also be hollow to
minimize the amount of packaging material used. Hollow or solid fins also
displace
packaging solution, reducing the amount needed. The arms may be radially
distributed
around the center of the support structure.
The flat top section may also comprise an optional central fillet 106a
centered in
the flat top section as shown in Figures 1A, 10 and 1N. The central fillet may
be
included in lens supports with or without a central column, such as Figure 1N
and 1A,
respectively. When a central fillet is included, it can have a width across
its longest
dimension of about 0.1 to about 3mm; about 0.1 to about 2mm, or less than
1.5mm.
The central fillet can have any shape, including a circle with a smooth or
scalloped
edge, triangle or square. The points of the triangle or square may be located
on the
arms, offset from the arms and may be rounded or pointed.
Upon opening the contact lens periphery will rest on the peripheral supports
105
and the lens may additionally rest on the central support or part of the
central support,
such as the shoulder transitions 102. The side sections 103 may have any shape
that
provides minimal contact, and preferably no contact with the contact lens upon
packaging opening and drainage, such that upon lens transfer the desired
contact area
differential is achieved. The side sections may be straight (non-curved), as
is shown in
Figures 1E3 through F. The lens may also have no side supports, as shown in
Figure 1J,
where the flat top section 101 is supported by a central column 108. As
solution drains,
the lens may collapse toward central support. The configuration of the
peripheral
supports and profile of the lens supports of the present invention, including
the central
support (if present) do not substantially match the lens profile and prevent
the lens from
deforming or interacting with the lens support during drainage so that the
lens resumes
its shape and does not stick to the central support during lens transfer.
Preferably, lens
support profiles which do not substantially match the lens profile include
central support
profiles which provide clearance between the lens and side support (if
present) of at
least that provided by straight angled side sections with an outward angle
from vertical
of no more than about 10 , including central supports which have no side
sections, or a
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concave curve in the side section. It will be appreciated that lenses with
higher moduli
(such as silicone hydrogels) may deform less and may require central supports
with less
mismatch.
The height of the flat top section (when included) is measured from the point
of
contact between the lens and peripheral supports to the top of the shoulder
and can
vary depending on the saggital depth and curvature of the contact lens. For
effective
transfer at least about 0.5 mm, about 0.5 to about 2 mm, 0.5 to about 1.5 mm,
or about
0.8 to about 1mm of deflection from the undeformed contact lens apex may be
desirable. For a contact lens having a saggital depth of 3.8 mm, flat top
portions
having a height of about 2 mm to about 3.3 mm, about 2.5- 3.3mm, or about 3 to
about
3.5mm may be used. Column heights which are less than about 2 mm can trap
packaging solution in the support base and encourage the lens to deform and
buckle in
the center. These heights, whether measured from the apex of the fens to the
top of the
flat top, if present, or from the base, will provide the desired contact area
between the
finger and the lens to provide consistent lens transfer, without inverting the
lens.
Removing the central column and leaving a void in the center can also provide
the desired lens transfer, particularly with lenses with a neutral shape after
drainage.
The void can have a diameter between about 5 mm and the diameter of the lens
(which
provides a support with only peripheral supports as in Figures 1F and 1M). The
void
can be clear to or below of the base of the lens. The void is desirably at
least 5 mm
throughout to provide adequate drainage.
Any structure below the void preferably has a low surface area so as not to
interfere with packaging solution drainage. For example, for a void extending
to the
base of the lens, at least about 50% of the area of the void at base would be
clear.
Voids which extend below the base of the lens may have structures with greater
surface
area, so long as those structures do not project above the base.
The length of the arms may also vary, depending on where and to what the arm
attaches in the flat top region and whether the arm has a peripheral support.
Arms that
attach to a center support, such as shown in Figure 1A, may have a length from
the
shoulder to the center point of about 1.5 to about 4.5 mm, about 2.5 to about
4.5 or
about 3 to about 4.5 mm. The length of the arm side section (when present) is
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determined by the height of the lens support, and may be from about 1.5 to
about
4.5mm about 1.5 to about 3.5mm, or about 2 to about 3.5mm.
The sides sections may be perpendicular relative to the base, or may have any
angle 103a (Figure 1A) or curve that is less than the curvature of the lens,
such that the
desired contact area is not exceeded. Suitable angles include up to about 150,
or
between about 1 and about 100 outward from perpendicular.
The angle 103b at the elbow transition between the side section and the
peripheral support (when connected to the arm) may be between about 60 and
about
120 , or about 80 and about 100 .
The number and shape of the arms may also be varied, so long as they provide
the desired balance of efficient drainage of the packaging solution upon
opening, and
contact area with the lens. The packages of the present invention may have one
or
more, three to eight, or three to six arms forming the central support, which
may be
designed to provide the desired contact area between the lens and finger, and
resistance along the flat top against the finger touch, but only transitory
contact with the
contact lens at the optional side sections and shoulder transitions. The
shoulder
transitions may be disposed radially around the center of the support. The
shoulder
transitions can be spaced at roughly equal angles from the center. The arms
may be
planar as is shown in Figure 1A, or curved, for example in a U-shape (not
shown), or
may be branched, for example in a straight or curved "Y" shape 101b, shown in
Figure
1B, a U-shape or a T-shape. Branching of the arm(s) may occur within the flat
top
region as shown in Figure 1B, or at the peripheral support 105c, as shown in
Figure 1C.
The support may have all planar arms, all branched arms or a mix of planar and
branched arms, for example two branched arms and two straight arms as shown in
Figure 10, three branched arms as shown in Figure lb, or all planar arms as
shown in
Figure 1A. Examples of suitable arm configurations include three to eight or
three to
six planar arms, 3 straight or curved Y-shaped arms, 2 to 4 planar arms and 2
branched
arms (which may be straight or curved Y-shaped, U-shaped or T-shaped) arms and
two
planar arms and 2 branched arms (which may be straight or curved Y-shaped, U-
shaped or T-shaped). The arm configurations may provide shoulder and
peripheral
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support contact points which are disposed along arm planes (Figure 1A), or
shoulder
and peripheral support contact points which are offset from each other (Figure
1C).
Each arm has a cross section sufficient to provide a lens support having
resistance to prevent lens collapse during drainage, or excessive contact
between the
lens and lens support during lens transfer. The lens support is preferably
formed from
rigid materials, and the resistance of the arms may be controlled by the
modulus of the
lens support material selected and the dimensions of the arm. Rigid plastics
which are
suitable for injection molding small parts, such as polypropylene homopolymers
and
copolymers(COPs), cyclic olefin copolymers (COCs), and mixtures thereof are
suitable
materials. Depending on the additive packages included polypropylene homo- and
copolymers generally have flexural modulii in the range of 1100-1800MPa, COPs
and
COCs have flexural modulii in the range of 1800-2900 MPa, and blends of
polypropylene and COPs or COCs may have flexural moduli' in the range of 1100-
2900
MPa. The polypropylene may be nucleated, controlled rheology or both, and both
Ziegler-Natta and metallocene catalyzed polypropylenes may be used.
Polypropylene
polymers may also include additives including processing aids such as glycerol
monostearate, zinc stearates and calcium stearates, fillers which can modify
the
properties of polypropylene and the like.
References throughout this description to conventional injection molding
processes and the use of materials conventionally applied to injection molding
should
be understood as exemplary. Those of skill in the art vvill appreciate that
other means of
manufacture are possible within the scope of the appended claims, including
but not
limited to alternative molding processes, thermoforming, 30 printing, and the
like.
The width of the arms can vary between the limits of the selected molding
process and widths necessary for efficient packaging solution drainage upon
opening.
Suitable arm widths include about 0.5 to about 1.5mm, about 0.5 to about 1, or
about 0.5 to about 0.7 mm, and it will be appreciated that lens support
designs having
fewer contact points may have thicker arms.
The height of the arms may vary from the limit of the injection molding
process to
the height of the arm from the base, in which case, the arm is a fin, as is
shown in
Figure 1E and H, which may be attached to the base, be molded as a part of the
base
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or may rest on the base. When the arm is not a fin, it can have a height of
0.5 to about
1.5mm, about 0.5 to about 1, or about 0.5 to about 0.7 mm. It will be
appreciated that
materials with lower modulii may benefit from arms that have a larger profile
in either
the height, width or both.
Suitable materials for the lens support must also be sterilizable, non-
leaching,
suitable for use with biomedical devices and inexpensive. Preferably the
materials are
also recyclable. The lens support materials can, but do not have to be,
optically
transparent. The lens support materials may be non-polar to encourage drainage
of the
packaging solution. Non-polar materials are those that have a contact angle of
greater
than 90 via the sessile drop method using deionized water at 25 C.
As can be seen, the lens support of the present invention can have a range of
arm and peripheral support configurations and features and are not limited by
the
specific combinations shown in the Figures and discussed herein.
Additional combinations of arm configurations will be apparent to those of
skill in
the art with reference to the teachings of the present application. The only
limits on the
design of the arms are the ability to mold the lens support, and the number
and orientation
of contact points to balance lens support with the desired drainage upon
opening.
Packaging Solution Drainage
The packages of the present invention may have additional features which with
the
lens support allow the packaging solution to be drained from the lens and lens
support.
The additional drainage features provide a drainage path for packaging
solution. The
drainage path creates, upon opening, an angled fluid film that forms between
two solid
members, such as adjacent peripheral supports, a generally vertical fluid film
that forms
between two solid members, such as a central column and a side section, or a
steep or
generally vertical path along a smooth solid surface, such as a side section.
The
shallower the angle of the drainage path, the easier it is to break the flow
path and
encourage the formation of packaging solution trapped between the lens and
lens
support, including reservoirs and residual films. Angled drainage paths having
an angle
between 10 and about 90 are suitable. Lens support and drainage features
with sharp
edges and very long routes can also break the drainage path.
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Integrally angled or elevated lens supports, as described above, may provide
the desired drainage. Lens supports may also be disposed horizontally on the
lens
base and comprise a lifting structure, as described below. A drainage channel,
when
present, cooperates with the lifting structure to create a temporary film of
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 which extends outward from the arc of the
peripheral ring, at least partial peripheral ring or the arc formed by the
distal ends of the
non-elongated peripheral supports. The drainage channel comprises a gap
between
two adjacent members or a when a single member is used, a split in the single
member.
For lens supports without a full peripheral ring, the drainage channel gap may
begin at
any point inside the lens periphery. For supports with a full peripheral ring,
such as
those shown in Figures 10, 11, and 1M-10, the drainage channel gap may begin
either
at the inner edge of the peripheral ring, as shown in Figure 10, or at any
point inside the
lens periphery. The drainage channel can extend at least 2 mm, about 2 to
about 4mm
or about 2.5 to about 3.5 mm in length beyond the peripheral ring or lens
periphery if no
peripheral ring is included. The drainage channel gap 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. Thus, in Fig 1E, the portion of gap 111 which is inside
the
periphery of the lens, does not substantially participate in drainage.
The upper limit for the length of the drainage channel is defined by the final
size
of the packaging and if included; the lifting structure.
Referring to Figure 1B, the drainage channel members 115 may be formed by
extending adjacent peripheral support sections 105 beyond the arc of the at
least partial
peripheral ring 109 and joining the distal ends via a crosspiece 114 to form a
gap or
open channel 111 between the drainage channel members 115. As shown in Figure
10, the channel members 115 may be attached to and planar with the at least
partial
peripheral ring 109. As shown in Figure 1D, drainage channel 113 may also be
formed
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by extending ring support structures 105 from a point 112 inside the lens edge
to a point
beyond the arc of the at least partial peripheral ring and joined at the
distal end by
crosspiece 114. The drainage channel may also be formed by attaching the
channel
members 115 to the arms at any point, including, when the arms are fins, as
shown in
Figure 1F, to the bottom of the fin. The drainage channel may also be formed
by
providing a gap in the peripheral ring with planar arms extending therefrom,
such that
the peripheral ring and drainage slot 113 form a keyhole shape, as is shown in
Figure
10. When present, the peripheral ring/partial peripheral ring may connect to
the
elongated arms.
The drainage channel members 115 may be straight as shown in Figures 1C-C, may
be curved as shown in Figure 1B, may flare out at the peripheral ring arc and
taper in
from the arc to the distal end or may be tapered from the at least partial
peripheral ring
to the distal end of the drainage channel. Any taper may be straight or
curved. When
the drainage channel is tapered, the channel tapers toward the crosspiece 114.
The
drainage channel may be about 0.8 to about 3mm wide, and when tapered may be
about lmm or about 0.8 mm wide at the distal end or cross piece.
Other drain channel configurations not illustrated or those that combine
aspects of
the exemplary configurations depicted are possible and within the scope of the
appended claims as will be apparent to those skilled in the art in view of the
balance of
this disclosure. Furthermore, in some embodiments, a drainage channel may be
omitted entirely. For example, when the lens support is fixedly angled
relative to the
bottom of the base, such as in Figure 1H, the drainage channel is not
necessary, and
the angle of the lens support provides the desired drainage upon opening the
package.
Lens Presentation
The package of the present invention may also comprise a lifting structure for
lifting the lens support from the lens solution. The lifting structure may
present the lens
support and lens from the base and packaging solution by any suitable means
including
tilting the lens support up, tilting the base down, raising the lens support
up from the
base, lowering the base down, or any combination thereof, and the like.
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The drainage channel, in cooperation with other features of the package may
function as the lifting means, or the lifting means may include additional
structures such
as springs, hinges, levers, pivot arms, folds, mechanical traps, handles and
combinations thereof. The lifting member may comprise a rigid elongated member
extending outward from a structure disposed along the bottom of the lens
support,
which may form part of the drainage channel. For example, lens supports having
elongated drainage channels 115, may include a hinge line in the package base,
such
as is shown in Figure 2. Such a hinge line may be formed by a flexible sheet
as the
bottom-most layer of the package base, with molded plastic back and front
sections
which may abut each other or be separably attached to each other along the
line of the
fold 216, which allows the front 217 and back 218 of the base to pivot along
fold 216,
raising the lens support and lens 200 from the packaging solution. When a fold
is
included, it is preferably located outside the arc of the peripheral ring and
transverse to
the drainage channel and drainage gap, as is shown in Figure 2. The fold, when
included, will define the distal end of the drainage channel, and should be
positioned
least 1 mm, about 2 to about 4mm or about 2.5 to about 3.5 mm in length beyond
the at
least partial peripheral ring or lens periphery if no peripheral ring is
included. The
position of the fold along the channel members may be selected to provide the
desired
lift separation from the package and drainage of the packaging solution away
from the
lens support and lens, such that upon separating the lid from the base to open
the
package, the distal end of the lifting structure pivots downward along the
pivot line, the
lens support is lifted out of the packaging solution and the solution is
drained away from
the lens. Upon opening the lifting structure pivots about the fold line to an
angle of about
15 to about 80 , about 20 to about 70 , about 30 to about 60 or about 40
to about
60 relative to level.
For lens supports having shorter channel members, such as the keyhole
configuration shown in Figure 1C, the fold may be adjacent to the peripheral
ring arc, if
the peripheral ring is more than 4mm larger than the contact lens diameter.
For lens
supports with longer channel members, the fold may be located between about
0.2 mm
to the distal end of the drainage channel, about 1 mm to the distal end, about
2mm to
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about distal end of drainage of the channel member's length from the
peripheral ring
arc.
The drainage channel member is preferably rigid across the fold line and may
be
fixedly attached to the front section of the base sheet. Any means for
attaching the
distal portion of the channel member to the base may be used including, an
adhesive,
glue, any suitable weld, including, but not limited to heat, ultrasonic or
laser welding, or
a mechanical trap.
When the drainage channel also functions as a the lifting mechanism, it may
have
any configuration suitable as a drainage channel, including at least two
elongated
peripheral supports extending beyond the arc of the at least partial
peripheral ring,
channel members extending from the peripheral ring, or separate channel
members
extending from the bottom of the lens support, any of which may connect at
their distal
end.
The lifting mechanism may also be a flexible attachment 245 between the lens
support 236 and lid 235 and is located opposite from the lid removal tab 228,
such as is
shown in Figure 2B. The flexible attachment can have any suitable structure,
include a
hinge, a flexible fold, pivot arm, mechanical trap and the like. The action of
pulling up
tab 228, and lid 235 opens the package and also lifts lens support 236 from
the base
240, presenting the lens 200 for removal by the user.
A simple loop, tab or handle could replace hinge 245 as the lifting mechanism.
The
user could open the lid and raise the lens support from the solution by
lifting on the tab
or handle.
Other hinge and lever configurations are known in the art, such as those
disclosed in
US20140027462, 0E4415003 and JP6339322. Alternatively, the lens support side
sections may be deformable, replaced with a spring structure, or a spring
structure may
be included under the peripheral supports or peripheral ring, such that in the
closed
position the lid engages with the lens support to compress the support,
without
compressing the lens. When the package is opened the spring relaxes and lens
support raises the lens above the packaging solution. In this configuration,
the
peripheral supports, and central support top section (if present) are
preferably made
from rigid materials to limit contact between the lens to lens support and
provide
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resistance during lens transfer. Any deforrnable structures incorporated under
the
peripheral supports should be designed not to detract from any drainage
features
included in the lens (including peripheral supports and rings).
It will be appreciated that lifting mechanisms which raise the lens parallel
to the base
may not need a separate drainage channel.
Either the back, front or both may further comprise a reservoir 219 for
capturing the
packaging solution when the lens is raised from the base. The bottom of the
package
may comprise a retortable film, including multilayer films which are used for
the
packaging of contact lenses, may be formed from molded plastic or may have
retortable
film bottom, attached to base walls of molded plastic. Any combination of
materials may
be used for the base, so long as they meet the described performance
requirements.
Lid
The package of the present invention further comprises a lid. In conventional
contact lens packages the contact lens sits in a molded plastic base, having a
bowl to
receive the contact lens in a concave, bowl up position. A laminated foil
sheet is heat
sealed to the molded plastic base. In the package of the present invention,
the
laminated foil sheet forms the outer layer of the base of the package, and
optionally the
lid. The lens support and optional package side walls are attached to the
base, and a
molded plastic lid, or a flexible foil sheet and a molded plastic frame
between the lid
sheet and the lens, is releasably attached to the package base via a
retortable seal,
forming a cavity comprising the lens solution, lens and lens support. When the
lid
comprises a flexible sheet and a molded plastic frame, they may be separate or
bonded together by any suitable means, including adhesive, glue, thermal
bonding,
welding such as heat, ultrasonic or laser welding, or a mechanical trap, and
the like.
In addition to sealing the package, the lid may also be designed to control
the flow
of air into the package upon opening. It is desired that the contact lens
remain on the
lens support upon opening, instead of sticking to the lid. To achieve this air
entering the
package upon opening may be directed to travel over the top of the lens first.
Two features have been found to be beneficial in directing the air over the
lens upon
opening: air entry guides along the inner lid surface and an air entry scoop
at the
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designed point of opening, such as inside a retortable seal. Packages of the
present
invention may include, one, both or neither of these features.
The air entry guides provide space for the air to travel above the lens,
without getting
trapped or diverted and may also cooperate with the lens support to prevent
the lens
from lifting or sliding off the support structure until some air has entered
the package
above the lens. The contact area between the air entry guides and the lens is
preferably low, less than about 50 mm2 or less than about 30 mm2.
The air entry guides may be molded into the lid, either on the inside surface
of the lid
or as a projection from the lid or may be a separate structure disposed
between the lens
and the lid when the package is sealed. Upon opening the package, the air
entry
guides direct air entering the package along designed path over the top of the
lens,
ensuring the lens remains on the lens support in the desired convex
orientation. The air
entry guides are disposed along the direction the package lid travels upon
opening the
package. The air entry guides may have any orientation other than
perpendicular to the
path of desired air flow. When the package is designed to be opened from the
front, the
air entry guides are preferably disposed from the front of the package to the
back and
the intentionally designed path is over the lens from the package front to
back.
Suitable air entry guides may include prongs 321 projecting from the lid
around the
periphery of the lens as is shown in Figures 3A and 3B. The prongs maybe be
rigidly
mounted to a support ring or a molded plastic ring (Figure 3A) or may be
flexibly
mounted on a flexible sheet (Figure 38), such as lidstock. The prongs may be
radially
disposed around the periphery of the contact lens, generally within 1 mm of
the lens
edge. The air entry guide can contain prongs around the entire periphery or
primarily
located along the front, sides or front and sides. The prongs may be adjacent
to each
other as is shown in Figure 3B or may be spaced apart as is shown in Figure
3A. When
radial prongs are used, the optical zone of the lens may be free of prongs to
encourage
air to travel over the top of the lens while the prongs keep the edges of the
lens from
sticking to the lid.
The air entry guides may also be in the form of continuous or discontinuous
(broken) ribs. The ribs can be attached to the inside surface of the molded
lid (Figure
30) or included via a separate molded structure (Figure 3D). The ribs are
aligned
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parallel to the path air enters upon package opening. The ribs may be spaced
at least
about 2 mm apart, about 2 to about 5 mm apart, or 2 to about 4.5 mm apart. The
ribs
may run in a straight line from front to back (Figures 30 and 0) or may curve
around the
optic zone (Figure 3E) to prevent interaction between the ribs and the contact
lens,
which can cause optical distortions in high shape memory hydrogels. The ribs
may run
"edge to edge" across the inside lid surface, or their start or finish may be
offset from
the edge as shown in Figure 3G.
The ribs may also extend away from the lens, forming recesses(s) 337
projecting up
from the lid surface as shown in Figure 3H. Such recesses may act as an air
entry
guide during opening as well as an air capture space, described below.
The ribs may have straight walls, may be wedge shaped, may comprise and arc,
or
may have one straight wall and one angled or arc shaped wall. The angled or
arc
shaped wall may slope along the curvature of the contact tens.
The rib height may be the same from the front of rib to the back (outer ribs
in Figure
3B) or may be larger in the front than the back (Figures 30 and 3G). The ribs
may have
a shorter profile over the optic zone, as shown by the central rib in Figure
30 or there
may be a gap in the ribs ("broken ribs" 322b), as shown in Figure 3F. Air
entry guides
comprising a central rib with a stepped-down rib height across the optical
zone are
effective in directing the air in the desired direction, while also minimizing
contact with
the optical zone of the contact lens. As shown in the Figures different height
profiles
and shapes can be incorporated into a single air entry guide structure.
The ribs may have a height of at least about 2 mm, which may extend from the
interior of the lid toward the contact lens or may extend away from the
contact lens and
define a separate air entry channel. Rib heights may be at least about 2 mm at
the
highest points, such as those at 522 (the air entry guides outside the optic
zone) and 0
to about 0.5 mm at the lowest points, such as those the back of the rib in
Figures 30
and 3G or the midsection of the center rib in Figures 3D, E and F. Below a
peak rib
height of 2rnrn in at least part of the rib the air bubble may not propagate
across the
entire top of the lens and the lens may stick to the bowl. Rib heights above
about 4 mm
may undesirably increase the size of the package and volume of packaging
materials
and packaging solution needed.
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When straight ribs are used with shorter profile in the center rib 322a
(Figure 3D),
the maximum length of the stepped-down profile along the rib is about 8.5mm.
When
curved ribs are used with a shorter profile in the in the center rib 322a
(Figure 3D), the
maximum length of the stepped down profile along the rib is about 9mm.
In addition to minimizing the height profile of the portion of any ribs 322a
which
traverse the optic zone of the contact lens, adjacent ribs 322b may be curved
outside
the optic zone. When curved ribs are included, the diameter of the curved rib
region
may be up to 11 mm or between about 7 to about 11 mm or about 8 and about 11
mm.
When the ribs are part of a separate molded plastic frame, it may comprise
cross
supports on the back side of the ribs. However, the height of the ribs should
ideally
maintain at least about 2mm of clearance between the lens and cross supports
to
provide the desired airflow. Preferably when cross supports are used they are
located
on the back of the ribs and do not protrude or extend into the pathways
defined by the
air entry guides. Preferably the air entry guide structure is free of
transverse structures,
such as cross supports, or has less than 3, or 1 or no cross supports.
When the air entry guides are a separate structure from the lid, as is shown
in
Figures 3D-F, the air entry guide may also comprise a full or partial ring
around the air
entry guides, shown as 327 a in Figure 3E and 327b in Figure 3B, respectively.
When
used, such air entry guides may be attached to the lens support by a hinge
(not shown)
opposite the front of the air entry guide, to form a clamshell structure
around the lens,
which can then be sealed in a single folded laminated sheet or sealed between
two
separate laminated sheets, which may be the same or different.
In addition to forming a sealed cavity to hold the lens and packaging
solution, the
lid of the present invention may also cooperate with the lens support to
maintain the
lens centered around the support with minimal contact between the optical zone
of the
lens and the support and lid. For lenses with high shape memory, the ribs may
be
designed so that any contact between the lens and the lid or lens support
while the
package is sealed is transitory.
A second feature that may contribute to air flow control is the air entry
scoop 324,
shown in Figures 3G and H and as 224 in Figure 2B. When included, the air
entry
scoop is located at the designed point of opening, inside the retortable seal,
which is the
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front of the package in Figure 3G. The scoop may be aligned with the opening
tab,
either directly as shown in Figures 3G and 3H, or may be offset, but aligned
with
opening tab 228 as shown in Figure 2B. In this embodiment, scoop 324 projects
out
from the periphery of the contact lens edge at least about 1 mm or at least
about 2mm,
and is located within the seal. The length of the projection is limited only
by the desired
size of the package. The air entry scoop has a width between about 2mm and the
inner
diameter of the seal arc 325. The air entry scoop may be shallower than the
lid and
may slope into the lid cavity, as is shown in Figure 3G. Aside from the
dimensions
above the scoop may have any shape including but not limited to round, ovoid,
triangular, square rectangular or irregular. Packages of the present invention
may
forego a separate air entry scoop such as by providing at least about 2mm
clearance
between the interior lid wall and lens support at the opening tab.
Figure 3G is an inside view of a package lid and skirt region. The lid would
be
sealed to a film base along seal line 326. The air entry scoop 324 is at the
front of the
lid and comprises the front section of three broken air entry guide ribs 322a
(which
traverses the middle of, but has a shallow height within the optic zone) and
322b (which
are curved around the optic zone of the lens). The package is opened by
pulling up tab
328, which separates the lid from the base starting at the distal end of the
air entry tab.
The tab may have any form including a foil or plastic tab, grip, ring pull,
handle or the
like.
Air Bubble Management
For some lenses, it may be desirable to minimize contact between the lens and
any air bubble in the package while it is sealed. While it is possible to
design a package
without any air bubble upon sealing the package (for example by using a two-
sided foil
pouch as the outer base and lid layers), air may still diffuse into the
package over the
lens shelf life. Thus, it may be desirable to include features within the
package to
capture the air bubble away from the lens, preferably in all storage
orientations. As
discussed above, this may be more desirable with lenses with longer shape
memories.
The lids of the present invention may further comprise at least one air
capture
space away from the lens optic zone for air in the sealed package to occupy.
The air
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capture spaces are designed such that the air remains in at least one air
capture space
away from the lens regardless of package orientation. The air capture space
may have
a volume equal to or slightly greater than the volume of air to be sealed in
the package,
and any air which may diffuse into the package during storage to insure all
the air
present at sealing, and any that might diffuse in during storage are retained
away from
the optical zone of the lens.
The air capture space may be designed in a number of ways. For example, as
shown in Figure 3G, the lid may further comprise a depression or dimple 329
above the
center of the lens support to force any trapped air up around the periphery
330 of the
dimple 329 and away from the lens apex, not shown. The depth of the dimple is
selected so that the nadir of the dimple in the lid interior, or any air entry
guide does not
touch the apex of the lens when the package is sealed. The gap between the
optic
zone and any air entry guide or dimple is between about 0.25 and about 2 mm.
Figure
4A is a drawing of the exterior of a package comprising a lid of the present
invention.
The dimple 430 is surrounded by an air capture channel 431. The depression
formed
by the dimple displaces any entrapped air into the air capture channels. The
dimple
may have a diameter of at least about the diameter of the optical zone of the
lens. The
combination of the dimple and the air capture channel holds the entrapped air
in
positions ranging from upright (base down), through 900. When the package is
upside
down, the air bubble is above the lens edge, and not a concern.
The channel 431 may have the form of a ring as shown in Figure 4A or may have
any other connected shape which provides sections which are higher than the
center of
the lid. For example, the air capture space may have the form of a continuous
channel
around the inside seal edge, with sections above and below the apex of the
lid, such as
shown in Figure 4B, with 3 raised channel portions 431a. The dimensions of the
air
capture channel may be determined based upon the volume of air to be included
in the
package and the amount of air which will diffuse in during storage, which can
be readily
calculated. The channel may have any cross-sectional shape including rounded
edges,
half round or half oval, rectangular or square. In some embodiments, the
channel may
have an interior width of about 1.5 to about 3 mm, or about 2 to about 3 mm.
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Instead of a channel, or incorporated into the channels, the air capture space
may comprise at least two air pods protruding from the lid along the inner
seal edge.
The raised channel portions 431a in Figure 4B are examples of 3 air pods
linked in a
continuous channel. The air pods 331a may be linear or arcuate (as shown in
Figure
3H), be parallel or transverse to the air entry direction, and may be
separated by the
dimple or connected by a connecting channel 337. The air capture space may
comprise at least one, two, three or more air pods, with or without connecting
channels.
The air pods may be wider, taller or both wider and taller than the connecting
channel.
The air pods and connecting channel may have any cross-sectional shape that
can be molded, including rounded edges, half round or half oval, rectangular
or square.
The connecting channel may have an interior width of about 1.5 to about 3 mm
when it
is desirable for the air bubble to pass between pods, or about 0.5 to about 2
mm in
designs meant to prevent the air bubble from leaving the pod.
Air captures channels and air pods can be included in a lid with or without
dimples.
The lens support and lid may be designed to cooperate when in the sealed
orientation to keep the lens centered around the support structure without
resting on the
support structure or lid. This is more important for lenses that have longer
shape
memory, such as silicone hydrogel lenses, and the optics of the lens can be
distorted by
extended contact with any packaging feature or any air bubble trapped in the
package.
Contact between the support, lid and contact lens during storage and shipping
may be
acceptable with conventional hydrogel contact lenses, as they have shorter
shape
memory.
The lens support may be designed in a number of configurations to provide the
desired drainage and support so long as the primary functionalities of
providing
sufficient drainage and contact with the lens sufficient to insure consistent
"one touch"
lens transfer to the finger are met. It will be apparent to those skilled in
the packaging
art that the packaging features described herein may be used in a variety of
combinations to achieve the desired one touch packages. For example, if
packaging
solution is trapped between the lens and support, the efficiency of the
drainage
pathways may be increased, for example by increasing the open area beneath the
lens
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support, decreasing the contact area between the lens and support, decreasing
sharp
edges and shallow drainage paths, adding a drainage channel, with or without a
tilting
or lifting means or a combination thereof. If the lens sticks to the lid upon
opening, air
entry guides and/or an air entry scoop may be added.
The benefits of the packages of the present invention are apparent in use.
Figures 5A and B include examples of packages of the present invention having
different combinations of features. The figures and descriptions are exemplary
only and
should not be considered to limit the package designs of the present
invention.
Figure 5A shows a view of the open package 500. There is included in the
package 500, from top to bottom: a molded plastic lid 535 with a leak-free
seal 526 on
the outer perimeter of the lid cavity. Beneath lid 535 is air entry scoop 524.
The air
entry scoop in Figure 5A is an integral structure within the lid but could
also be separate
structure from the lid. The air entry guides 522 are in the form of broken
ribs, and direct
the flow of air above lens 550, so that the lens will not adhere to the lid
535 when
package 500 is opened.
In the sealed state, the lens 550 is maintained in the space formed between
package lid 535 and lens support 536 (lens cavity). The lens cavity may be
designed so
that lens 535 (particularly in the optical zone) is not compressed during
shipping, and
only minimally contacts the interior features of the package and maintains
integrity until
the package is opened. Also, the lens cavity should not provide too large a
gap between
the lens and interior package features, so that the lens is held in the
desired convex
orientation relative to the package base during shipping and storage.
A contact lens 550 rests below lid 535, upon lens support 536. The lens
support
may have a variety of configurations as detailed above. In general, the lens
support
536 holds the lens in the desired convex position, with minimal contact area
when the
package 500 is opened to insure efficient transfer of the lens to the finger
of the user.
Lens support 536 is placed on the base 540, which has a front base section
516, a base
fold line 517 and a base back section with a reservoir 519. The lens support
is attached
to the front base section 516, so that the lens support and lens can pivot up
along fold
line 517 from the back base section 518 upon opening. When the package is
closed
and sealed the base and lid form inner chamber 544. Inner chamber 544 is
designed to
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hold the correct volume of saline solution to allow the lens, lens support 536
and lid 535
to work together properly. Finally, base 540 also contains an outer reservoir
519, which
captures any displaced solution which drains out of inner chamber 544 upon
opening
the package.
The package is opened by pulling tab 528 upward, which breaks seal 526. Air is
introduced into package in a controlled fashion and is guided into the package
by air
entry guides 522 so that the lens is biased away from package lid 535 and
maintained
on lens support 536. This gentle force acts in conjunction with the draining
of solution
from the lens 550 and lens support 536 so that the lens is generally
maintained in a
"ready to use" position on the lens support 536. As the lid 535 is lifted, the
front of the
base 540 is lowered, pivoting lens support 536 about fold line 517 to drain
the
packaging solution from the lens 550 and lens support 536 and present the lens
for
transfer to the wearer's finger. The central optical zone of lens 550 is
generally clear of
contact with the arms, other than at the peripheral supports 505. The flat top
region 501
provide resistance to enhance the ability to transfer lens 550 to the finger
with "one
touch".
Lid 535 and reservoir 519 may be polypropylene or any other material which can
be used for medical device packaging, and base 540 formed with a foil or
laminated film
structure which is generally sealed to lid 535 via heat welding or any other
method
capable for forming a retortable seal.
Figure 5B shows an expanded view of another package of the present invention.
The air entry guide has a full peripheral ring 527 and is a separate structure
from lid
535. The air entry guide peripheral ring 527 connects to lens support 536 via
a flexible
connection 545, such as a hinge or a fold. The air entry guide and lens
support close
around lens 550 like a clamshell and protect the lens 550 from damage and
maintain it
in the desired position. The base 540 and lid 535 may be made out of any sheet
or
laminate film, and may be one single sheet folded opposite pull tab 528, or
may be two
separate sheets which may be made out of the same or different materials.
As shown in Figures 5A and 5B, the features of the package, including the lens
support, lid and the air entry guides, no matter how created, may be designed
to interact
with the lens outside the optical zone to prevent damage to lens optical zone.
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When the package is opened, such as by lifting the lid 535 from base 540, the
air
entry tab 524 and guides 522 direct the air over the lens 550, gently biasing
the lens
away from the inside of the lid and ensuring the lens remains on the lens
support 536.
Any packaging solution contained in package 500 is drained away from the lens
550
and lens support 536, such that only minimal packaging solution remains on the
back
side of the lens 550, and the lens support 536.
This gentle force acts in conjunction with the draining of solution and the
arms of
the lens support so that the lens is generally presented in a "ready to use"
position on
the lens support.
Because the contact area between the lens 550 and the lens support 536 are
minimized and the packaging solution effectively withdrawn, the wearer can
remove
lens 550 from the package with a single touch of a finger and adhere the
convex side of
the lens 550 to the finger. Thus, the apex of lens 550 is positioned on the
finger and
may be directly applied to the eye with its concave portion placed directly on
the
eyeball. There is no need for the wearer to transfer the lens from the fingers
on one
hand to those of the other, as is common with currently designed contact lens
packages. This improved series of steps not only is easier and more convenient
for the
user, but it also reduces contamination due to bacteria carried on the user's
fingers.
Thus, the present invention provides packages which effectively channel
packaging solution away from the lens and lens support and control the ratio
of the
contact area between the finger and lens as compared to the area between the
lens and
the lens support, ensuring that surface tension between finger and lens
exceeds surface
tension between lens and lens support. The lens thus presented, consistently
adheres
to the finger, providing a one touch" lens transfer experience to the wearer.
The 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.
As described above, 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 one touch packages. For
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example, lens supports with central lens supports may be desirable for lenses
with
moduli less than about 25 psi, new wearers not used to one touch lens removal,
or for
wearers with a more forceful touch. Experienced wearers and those with a
lighter touch
may need packages with only peripheral supports. It will also be appreciated
that the
packages of the present invention provide numerous opportunities to include
ornamental designs and features, for example in the design of peripheral
supports and
ring, arms, fins, air management pods and channels, as vvell as overall
package shape
and profile.
In summary, the contact lens packages of the present invention incorporate
several novel fundionalities which may be combined in a wide variety of
combinations
as described herein to provide the desired one touch packaging, including the
following.
Preventing the lens from rotating off the support, which may be accomplished
by
Including a minimum of 3 points of contact on the periphery of the lens, which
may be
arranged in an acute triangle.
Preventing the lens translating horizontally across the support, which may be
accomplished by a horizontal or near horizontal contact near the periphery of
the lens,
where the lens surface is more steeply angled (located outside a central
region having a
diameter of at least about 5 mm, about 6 mm, or about 7 mm, or the contacts
can be
just outside the periphery of the lens.
Maintaining the lens, after drainage, in its neutral or near neutral shape for
presentation for lens transfer.
This may be accomplished by minimizing contact between the lens apex and the
support, which can be done by providing a central lens support with about 0.5
to about 2
mm, about 0.5 to about 1.5 mm, or about 0.8 to about 1 mm clearance between
the top
of the flat top section and the lens apex or leaving a void at least about 6
mm in
diameter and clear from the lens apex to about the level of the base of the
fens.
Resistance to the finger when dabbing
It is beneficial to increase finger surface area as well as control dab force
and
contact time upon dabbing.
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For lenses with low moduli this requires a stiffened structure under the apex
of
the lens, which may also improve the consistency of transfer for lenses with
higher
moduli, including silicone hydrogels. When present, the height of the
structure is no
lower than the base of the lens. The support structure may also be less than 2
mm
below lens apex.
= The shape of the surface may be flat or slightly concave (e.g. down to a
radius of curvature of about 10 mm), but may less preferably be slightly
convex (down to a radius of curvature of about 10 mm) or more concave
(e.g. down to a radius of curvature of about 6 mm).
= The diameter of the surface should be about 1-10 mm, preferably 6-9 mm
(to match fingertip size).
= The surface does not need to be continuous ¨ it may be made up of a
series of point or lines.
The optical zone is free floating and contact with the lens support during
storage
is transitory or non-existent. This can be achieved by making any central
supports
slightly lower than the profile of the lens (so that the lens only contacts
the support at
the periphery).
The following test methods were used in the Examples.
The root mean square wavefront error ("RMS error" or "RMS") measures the
deviation of the wavefront of a lens from the intended design wavefront. When
the
intended design is not known (such as when measuring commercially sourced
contact
lenses) the RMS can be measured by com parting the wavefront of a lens as
packaged
and sterilized in a conventional "bowl up" lens package with the same lens
repackaged
and sterilized in a package of the present invention.
A calibrated dual interferometric method was used for measuring root mean
squared (RMS) optical path wavefront deviation from lens design target ("RMS")
in
micrometers or microns (pm) with sphere/cylinder power and coma removed as
measured using a 6.5 millimeter aperture. The instrument consists of a custom
interferometer for the measurement of wavefront parameters and a Lumetrics
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OptiGauge II low-coherence interferometer. The two individual instruments
combined
are similar to Lumetrics ClearwaveTM Plus, and the software is similar to
Lurnetrics
OptiGauge Control Center v7.0 or higher. With the ClearwaveTM Plus, a camera
is used
to find the lens edge, and then the lens center is calculated, which is then
used to align
a 1310 nanometer interferometer probe at the lens center for the measurement
of
sagittal height and center thickness. The transmitted wavefront is collected
in series
using a wavefront sensor (shack-Hartmann sensor). Multiple parameters from the
transmitted wavefront of the contact lens are measured, and others are
calculated from
those measurements.
From the data collected, difference terms are calculated by comparing the
measured values from the target. These include root mean squared optical path
wave
front deviation from lens design target in pm (sphere/cylinder power and coma
deviation
removed) as measured using a 6.5 millimeter aperture (RMS_65).
The lenses were placed, concave down, in optical quality glass cuvettes free
of
scratches, cleaning streaks, water spots or condensation and filled with
packaging
solution. Only lenses which are free from visual defects (non-circular edge,
chips,
and/or tears in the edge, folded, inverted in the package) were selected for
measurement. The lenses were placed freely floating, without trapped air under
the
lens. The lenses were placed freely floating in the cuvette with care to not
deform or
damage the optic zone and without trapped air under the lens. The cuvettes
with lenses
are placed in interferometer, and the measurements are made at 20 C.
Examples
The following test methods were used in the Examples
The root mean square wavefront error ("RMS error" or "RMS") measures the
deviation of the wavefront of a lens from the intended design wavefront. When
the
intended design is not known (such as when measuring commercially sourced
contact
lenses) the RMS can be measured by com parting the wavefront of a lens as
packaged
and sterilized in a conventional "bowl up" lens package with the same lens
repackaged
and sterilized in a package of the present invention.
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A calibrated dual interferornetric method was used for measuring root mean
squared (RMS) optical path wavefront deviation from lens design target ("RMS")
in
micrometers or microns (pm) with sphere/cylinder power and coma removed as
measured using a 6.5 millimeter aperture. The instrument consists of a custom
interferometer for the measurement of wavefront parameters and a Lumetrics
OptiGauge II low-coherence interferometer. The two individual instruments
combined
are similar to Lumetrics ClearwaveTM Plus, and the software is similar to
Lumetrics
OptiGauge Control Center v7.0 or higher. With the ClearwaveTM Plus, a camera
is used
to find the lens edge, and then the lens center is calculated, which is then
used to align
a 1310 nanometer interferometer probe at the lens center for the measurement
of
sagittal height and center thickness. The transmitted wavefront is collected
in series
using a wavefront sensor (shack-Hartmann sensor). Multiple parameters from the
transmitted wavefront of the contact lens are measured, and others are
calculated from
those measurements.
From the data collected, difference terms are calculated by comparing the
measured values from the target. These include root mean squared optical path
wave
front deviation from lens design target in pm (sphere/cylinder power and coma
deviation
removed) as measured using a 6.5 millimeter aperture (RMS_65) .
The lenses were placed, concave down, in optical quality glass cuvettes free
of
scratches, cleaning streaks, water spots or condensation and filled with
packaging
solution. Only lenses which were free from visual defects (non-circular edge,
chips,
and/or tears in the edge, folded, inverted in the package) were selected for
measurement. The lenses were placed freely floating in the cuvette with care
to not
deform or damage the optic zone and without trapped air under the lens. The
cuvettes
with lenses are placed in interferometer, and the measurements are made at 20
C.
Examples
The following were used in the Examples, below.
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Buffered solution: 1000 g DI water, 13.55 gm NaCl, 27 gm boric acid, 5 gm
sodium
borate, 0.3 gm EDTA, and having a pH of about 7.4.
Packaging solution: RevitaLens Complete (Alexidine 0.00016%; Polyquaternium-1
0.0003% (P0-1); EDTA.
Polypropylene:
isotactic polypropylene homopolymer, having an MFR of 24 g/10
min, (Lumicene M3766) from Total
Lidstock: multilayer film comprising layers of oriented polypropylene (12 pm),
aluminum
foil (50 pm) and polyester film (12 pm).
Examples 1-6 and Comparative Examples 1-2
Several lens support architectures were evaluated to determine support
features
which can provide desirable lens support, package solution drainage and lens
transfer.
Each of the evaluated lens supports was 3D printed on a Form 2, using Fon-I-
dabs
Formlabs clear resin. The lens supports were printed with a drainage channel
terminating in a 90 lever to allow the support and lens to be lowered and
raised from a
packaging solution chamber having dimensions 30mm x 45mm x 25mm.
A 1-Day ACUVUE MOIST contact lens was removed from its package and
placed on each lens support while the support is submerged in packaging
solution to
allow for full wetting, and mounting the lens centered on the support. The
lens support
and lens were submerged in the packaging solution chamber for at least 5
seconds, to
insure is fully submerged with no air bubbles remained under the lens. Using
an eye
dropper, the packaging solution was withdrawn to expose the peripheral
support. The
support was then slowly pivoted from the remaining packaging solution using
the lever
and allowed to drain until the solution appeared to have drained from the lens
and
support or after about 10 seconds, which ever was sooner. The lens was
evaluated for
permanent fluid films, solution reservoirs and internal bridges between the
lens and
support. Photographs were taken and evaluated for lens centration, areas of
fluid
trapped between the lens support arms and the lens and lens deformation.
39
CA 03184193 2022-11-18
WO 2022/054031 PCT/IB2021/058376
To ensure a consistent dab surface and simulate a low adhesion finger, a
rubber
nitrile glove was worn on the hand used for dab testing. The test was repeated
at least
times for each support design, changing out the lens after 2 repeats.
The results are shown in Table I along with a representative photograph, and a
CAD drawing showing the lens support configuration.
Attorney Docket No,: VTN6069W0PCT1
Table 1
1
Ex, Support Representative Drainage 1' Perm Reservoirs
Bridges Drainage Observations 0
It Photo time Films
Speed t...)
o
Dab
=11-.).)
I :%7
,= -... ---
:iiI:i:im::::<:=...7 .45.7.:.... -...
...'"N:!:::, ....:::::=e:..;.:.:,... .., 5/5 None
Small Moderate Moderate Lens deformed in (.11
4=,
':ili:..,giZt.d:4:;:: ====,:i. ;:,' .'p ;.. ,
a
1-.
multiple test
õ.
Solution remaining
:::::'llti5::4'.;;3:N
gathers around
=0 iZ.0 '14:,*:::::NEgi!:::.:....... :.: ,... lens-support
.:::'
contact points, in
particular at the
front arms.
.
.
2 ..).7
- x,-,*,,,-,4,07,õ<...,47 .,
' .:;!;!!::;:;. . - 5/5 None Small-
Light- Moderate Lens deformed a
..==:õ:4::r ,..; ,.... Medium
Moderate lot and held
, solution in early P
.--*.Vf7.<16:,>;4iinb!.:54:*;:,:,::Z.-
õ.., = 0%:,..
o
stages of
.
,
4,:,,,,,..,.5.. ,::::;04,ry;');..-4,=,.
=*i:i::::;....:::',..====:.::.:,:=:=7./>: drainage, but did .
,
0:õ
not affect dabbing .
"
+
"
.= --------------------------------------------------
---- - .r ..'j.i.. ./ -7...;.< ---- -- .=*;'= -4,.4--- 20/20 + None
Small ..... .. . ,
õ Light Fast Excellent draina "
,
¨. a .:,,.......;...=
,
,
,
,
.::::iii: "0:,=.--AgAõ:,
:,..,. : .,, ...:=:=,.. .
,
..,* 2"'::::'..:y::::::H:nn:==============,,,,Ø..r,
'7.:40.?.=,f-T m
1.00......4U-
.....õiii:-::::mo;-.0
%
4 , 5/5 None Small
Light Moderate Lens deformed ;
lot and held
Iv
n
solution in early
stages of draina
.,,.:,.: :4,ii:On.;;=,=.,.
,.:. === N
' 'Nowiv.00
.
ts..)
(.11
------------------------------------------------------ A ----------------------
-- A -------------------------- Ce
CA)
.."41
Cf.
41
C
/".A 0/5 None etornesyevDeorecket NFoa....stVTN606re9onkikos
wrapped
õ,:.::::=:=:=:=:=.==.... ..... ___ .................x.,.....
w
' =
..,::::iii:i:i:i:iii:i::::::::::::::::*:::õõõ::::::::::.:.x.x...............
=
........ .........
w
, :.:....... -.,..
w
C E I. .... =:.=
..:iV
Ii4:....::ii:iii:i:i:i:i:i:i:::: ...'. " .i.:.<:: ..."' - ......
CA
.i:M', .....'"; A. '.'.....:-:.' ModerAatt
.6.
..
:.
=
=
,
..,.::::: ..õ .......õ..........õ.......
....: pped to
,..4
:
-,0Y:= ::::,;,
N:4,*õ.i. ...õ-,,i-?
:.*:=:õõ: :;i-;:::::i:::::..2:.,.;.;.4i,,,,m:4t..::.:,:::::'.':'MP'':
"-/.:m:iii::::::iiili::..,,=-..,::::::;..:..-.,.:.:
.,...-,:::.i:=0'::4,*:,.::::::,:i:i,,:;..,.;: -,,,- ..:=======... ,..:.::
themo scir:rydnPrdtarCii adn-rinac,igt oedi ua- mb n
' Ni...::.1.'=4`7.'
Moderate-
:',
':;ri:.:..i,iii,ri::::i.::::::::::::igi;ii::::::::::::::::E=f:if
Light
tdaphfrrtiaere:nrtyaat hgtgteeeomsof oedpcntioosn\
,ni,,tidieadol r
5/5
Fast
::..i.,=,/./.:::=õ;.::::::õ...:: -::::::::::::
---------------- ---
:ii:::. A,...Y:27:?,),,:-...
/:=== :.<5-:: /
None Small
=
. i/P = ,>
P
/ ej4;;,/k / õ,:::,
Slow
..:oamanplete
, :..- .,..f. Ø.õ:õ
light-
,
.3
None SmaH
darbyri marl an saPtgi dce of any
.,./. - . ,
5/5
Moderate
,
-.µ,$;., i
.....---::::,=iiq:: ::....
f.::. :=>.'0...=:. ::.
õ,..:::.:
:µ,.:::,-.),..:== :.:::::;...,..
6
:;::/
...4,4,....;::::.p:......,X4e.
,
,
..
,
..':
= ......................... . :,.= ===,..vs,
z.=====::::::::::::i::::::::::::::::::.:.::=x.':=/
,
,
:.,-=
-.<..::=::.::::::ni:::::::::::-..:.:=:......-.:===:-
oy:...õ..,00.233Kw0Ø4... ... -../ Ø 0::::=:=:=== '..,:.'.:::.:?:
:=:=:.::0.K.,.'
= . = . = = = = = = = ..
.. ::im., %,...i'=:=.= ::::''::..."'e ..... ;.:A
..:.;.:..= .. wasdrP ee nr mda tnarci sval Furtheri eg n1 1 reYdvs g. ri
' tsahst i e n nral ut g, tui e :1
-A::::.....4w ....",r:=::::::::0:;....:=:::.:=_ :...,:,:-*.;
Moderate
:,.....:=-=
Severe
wwrpereistehiel.:trvyinoistiitaruldcbrkartildongitnEi
support in every
=../=:... .
= ===::::=:.::::......= .
test.
Iv
/;:,:v./..,::::::::::,6:.....:=,:: ..-iii::::::::::::
Drains the initial
n
/7....: ..4.'.4.N.;:":. ..f.:i:=.*.ii:.::..:h.ii
1-i
CE2
,i:::::::::::: ,.;õ ,:.:i:,=;:? = .:,.............. ...,
..............-
buIk solution we
.*.:5A,
5
.:..:4..:::.:::i::i:::.:t.:i*.....::,::: 20/20 None Small
... : ::::::: zõ;:=...:..::=:-
.:.=::::::::::*:::::::K:i::::::::::......,=====
but consistently
w
o
w
...::-
leaves solution
,..
....
?.
---Us...,=4:== -
===,:::::'=====:=:::.=õ::;=,..,:.::,:.::::iii:i:;.:_:,.:::::...
t :N..:.:*.:=.7,7 '....'..::ii.:.:.Ø."....;.
cA
oe
c..4
yie
o=
4)':::...)...,0.- .)0..??,:t,..???.%. =
::.' '''Vg-0.-:. .
I
.;.,,..
.. .. ' )41,
aporoinuinsd. the lens-
õ
, . = .
support contact
42
Attorney Docket No.: VTN6069W0PCT1
CE3 0/2 None Medium-
Moderate- Slow Lens wrapped
,./..;; ;.-. .. ,e...'s
,. , ft; ",,,,J .. . Large Severe
onto spokes gives
,
- . poorer drainage. 0
:ex i'= , .
. n.)
. ....
Convex geometry
...... .W0S5:0e, z-,...õ,....,,,,..,.:.:::::,,,,'-'
..,.,.,..-,,:,:.!.µ,.... ..-7";f
provided t..)
"firle.N,, *. '
Ire
insufficient finger
contact
,, ;. tv: .. '.......f.1..,...;r.;;;=,'
-.*.*/*
.
The drainage for each lens was categorized on the following properties:
Permanent fluid films ("Perm. Films) are films that form between the lens
support structure and the (outside) surface of the lens
and do not break after drainage. The following rating scale was used:
= Severe (;- 50% of lens perimeter covered)
= Moderate (< 50% of lens perimeter covered)
O None
Solution reservoirs ("reservoirs") are larger volumes of solution that are
retained on the inside of the lens, after drainage has g
taken place. The following rating scale was used:
a
...
..
=
Large (lots of fluid visible, total
volume estimated > 50 pl) õ
..
...
= Medium (some fluid visible, total volume estimated 20-50 pl)
a
O Small (little/no fluid visible, total volume estimated <20 pl)
,
..
Internal fluid bridges ("Bridges") are regions where fluid menisci bridge
between the support structure and the lens. The ..
i
..
following rating scale was used:
* Severe ( > 15 mm of linear bridges)
= Moderate ( 5-15 mm of linear bridges)
= Light (< 5 mm of linear bridges)
Drainage speed is the time between lifting the lens out of solution until no
more change in drainage is observed. The following
rating scale was used:
*
Slow (> 5 seconds) v
n
= Moderate (2-5 seconds)
=
Fast (< 2 seconds) t4
r.,
,
,-,-,
Ge
,..,
-4
c,
43
CA 03184193 2022-11-18
WO 2022/054031 PCT/IB2021/058376
As the packaging solution drains from the contact lens, films of packaging
solution may form between lens edge and peripheral ring. Films formed at
beginning of
drainage are good, and for lens supports with good drainage, the films break
before
drainage is completed. Residual films remaining once drainage has stabilized
can
interfere with lens transfer. Films noted in the tables are residual films
that remained
once drainage had stabilized.
Examples where the lens deforms and wraps onto the support structure tend to
hold more solution in the lens. This can be detrimental to dabbing
(Comparative
Example 1), or slow down drainage (Example 4). The arrangement of both
peripheral
supports and central supports are important in reducing and preventing
wrapping. Lens
wrapping is significantly reduced with 6 peripheral supports (Example 3)
compared to 4
peripheral supports (Example 4). A poorly distributed central support
(Comparative
Example 1) had much more wrapping than a well-distributed central support
(Example
3).
The peripheral ring can also reduce lens wrapping, due to the surface tension
of the
films formed around the periphery of the lens. Example 1 showed less lens
wrapping
than Example 2 (no ring).
Example 5 is the same lens support as Example 3, but with a peripheral ring
added around the peripheral supports. Both Example 5 and 3 showed excellent
drainage speed (moderate-fast and fast respectively) and excellent drainage
efficiency
evidenced by no permanent fluid films, small solution reservoirs and only
light internal
fluid bridges.
Example 6 is the same lens support design as Example 2, but the arms are solid
fins which connect to the peripheral supports. The filling in the arm
structures slowed
the drainage speed, but the drainage efficiency was the same as Example 2,
confirming
that lens supports of the present invention with open arms or solid fins can
provide good
drainage and consistent lens transfer. The comparison between Example 2 and
Example 6 also shows that drainage speed may be decreased by removing
structures
below the lens support (such as solid fins).
44
CA 03184193 2022-11-18
WO 2022/054031 PCT/IB2021/058376
The lens support of Comparative Example 2 has a similar structure to Example
1,
but with curved side sections, which formed severe internal fluid bridges
which caused
the lenses to stick to the lens support, creating undesirably high lens to
support contact
area. The increased contact resulted in a 0% transfer rate upon finger
dabbing. Thus,
support structures that form more solution bridges are less likely to dab
successfully.
The lens support of Comparative Example 3 had a fully curved lens support,
with a
smaller radius than the lens support of Comparative Example 2, but still
evidenced
undesirable solution reservoirs and internal fluid bridges. Comparative
Example 3 also
had a fully curved top section, which provided insufficient contact area
between the lens
and finger upon dabbing (0% first time dabbing success).
Comparative Example 3-4 and Example 7-8
The lens support testing was repeated as described in Examples 1 using the
lens
supports shown in Table 2.
Attorney Docket No.: VTN6069W0PCT1
o
Table 2
_______________________________________________________________________________
__________________________________ N
t Ex. Support Representative Drainage
Photo 1 time Dab Perm Reservoirs Bridges sDpraeiendage
Observations
Films
.1,
#
7 5/5 None Small
Light Fast Minimal
!
o
c"
initial fluid
-i
retention
...
around the
1 .0;;;,... .. = ==/.4,,,,,,.õ,=>.
suppo
.,.,,,*,.: ;;.=== ................. .::::...:/4..:.' .. .: =-:* =
.::::..."""iAii;;;"%.x.Se-44. ......:, .,
::.::0VA.=...?; :::.:.. ........... structurtre.
,,, ..7:;;'''''';:::-..-..i.,: .
The only
.0', 11 .:*,.. = :'..::
place
',:,,,,..... .õ,::===/
.-:,..:;*:::::::, p::::::g. /4:*.;=.g,..
:.::::;;;;:::;:::=.:.:=..::.:.: .-...e ::.
:::::., .= :.:.:. -
:::::...:.::=:=:::::::::::::::::: :::... ...
significant
'....N;;;;õ::.:.:.:::=;.;=;=;=;:;::::::::::::::::::::::::::::::::.:
.....:.:.,
fluid is
0
initially held
is around the
....:
front arms.
r,
CE3 -./ ' 2/5 None Small
Moderate Fast Mode = ..."
"
initial
.7
i-
drain
.
0
Suffei
tm
49 . .:i:;:. ...,.-
.<'=/,i=...:W:::;::'''
lens r
:=-=fet14:0=04<<":=-*,,,, . ,:!:.
1%.:// f 5,;::*/ W'..7%. '= A '.::4j*./..'.
:::
''
Many
reser
on
41C..õ..,,..,.µ, / :=='==...., .. ... . . . . :=õ...:,=0:::::-
!:'.:.:::',:'''...i. .
arms. _
======õ. . 4/6 None Medium CE4 '
.. . ...
Moderate Moderate Fairlyu e npv
1-3
trappi
6-:
:
solutii
t4
..: .<1.10.6H7 A.
,
initial!
t'7J
Mostl=
tins ...==:.
-.;;;;;-,,z,.::;;::.,f,=,,,,..; ,, A,
!A
well.
00
'f.I5A %C ,:;.=.:
c., Some
i
left at
ter. I
46
Attorney Docket No.: VTN6069W0PCT1
Lens apex
occasionally
sunken
0
4..
t74
8 5/5 None Small
Light Fast Fairly large
amount of
.
trapped
r
. . ,
solution
$ yr
initially but
very quick
"*.=
drainage
<2s.
Occasionally
lens deforms
or slides.
The lens support of Example 7 has the same structure as Example 1 except 4 of
the side sections were removed,
which resulted in faster and more efficient drainage. The lens supports of
Examples 1, 5 and 7 show that lens supports
having substantially flat top regions and peripheral supports with a variety
of side or center column supports provide both
excellent drainage and lens transfer. Examples 8 and 9 show that drainage can
be improved by removing some or all of
the side sections from the lens support. Comparative Examples 3 and 4 and
Example 8 show that the arms in the flat top
section can be removed and the top of the side section can provide the
functionality of the flat top. Comparing Example 8
to Comparative Example 4, it can be seen that drainage and lens transfer can
be improved by widening the width of the
t=J
central void at the base. The lens support of Comparative Example 4 provided
slightly worse drainage than Example 8 as
packaging solution could pool in the base of the cone in Comparative Example
4. This was readily improved by widening
47
Attorney Docket No,: VTN6069W0PCT1
the width of the central void at the base (Example 8). Comparing Example 8 to
Comparative Example 3 shows that
increasing the angle of the side arms away from the lens decreases solution
bridges and improves drainage speed. o
w
=
w
w
Comparative Example 5
u,
.6.
=
,..4
Example 2 was repeated except that the drainage gap between the elongated
peripheral support was filled in. The .
results (with the data from Example 2 copied for ease of reference) are shown
in Table 3, below,
Table 3
Ex. Support Representative Drainage 1' Perm Reservoirs
Bridges Drainage Observations P
# Photo time Films
Speed
,
.3
Dab
.
,
2 ,,'. .."Iiiiir4:::177; , 5/5 None Small-
Light- Moderate Lens deformed a
.i:ii:i:iW p=?.:iiii::;: ... Medium
Moderate lot and held
4iz,:.z....0i ..:,.--;,,... .4,i,
,
õ...4r,:.'.. . ..::....,,.õ.õ,.... ,
õ....., solution in early ,
,
,
,.. .:::i:: r.::-.
stages of ,
.3
:- ..;..,.. 0.:::F; - ,....e:..,......'.
drainage, but di
not affect dabbi
CE5 ,..-''''''. 4iii 0/5 None
Medium- Moderate -- Slow + Reasonable init
..(.,?..:i::::i:i::::::::::
..:,:::.:.::::::::::::::::::::::i:
r,::: .....e:ii:...is::::::::::::::::::::i:i Large drainage. MinirT
::::mmii
further drainagÃ
1 ,
.:..,5!..i.:.'1_,...Liiiiaiiiiiii:!::4.! after initially bei
,0,,.=:-41 .,,,::::::::.<7 5: .. V::, .HiP:...,,i, = ,
removed frOM
IV
n
4 ....0 :.:. ..;::V ...;
,A,:.õ,..4,
,-i
I:::;
--, ,-.Aravio .......õ:0aiii....,-::..i::.,., ',/,.:.:,
r' 1 pp? 4!". . ' ,4
: ,44..
i "A
j
= /..-= .. ::::õ....../ ::,:,:.
= , õõ,., ..., ,,/ /
.....õ,,:,i;i solution
remaining on th
5
w
=
w
lens prevented
ur
transfer to the
oe
(..4
finger.
-1
o,
48
Attorney Docket No.: VTN6069W0PCT1
0
t..)
Examples 9-10 and Comparative Examples 6-7
t..)
,
The procedure of Example 1 was repeated but lens supports comprising
peripheral supports without any
4..
t.1
central supports were evaluated. The results are shown in Table 4, below.
.
Table 4
Ex. Support Representative
Drainage 1st time Perm Reservoirs Bridges Drainag Observations
# Photo . Dab Films
e Speed _
,
,
9 5/5 None Small-
Light- Moderat Poor initial drainage with
õ/ 'IV .. ./,...1.PV''... Medium
Moderate e significant lens 0
= = .
==.lip.=]??..;,.//=.4.iw:=,.,õ deformation. .
w
4e'
In some cases the lens .
,
drained entirely allowing
.
.""'..iiii:::!,:::= ..=
.?=-=,-= ' it to pop back up ,,,
e
(although this wasn'
" i
= ,4
t.NaggiV:ii: necessary for succe I ,..
i
,..
'iiiiiIiiiiiiiiiiiiiiiiii:1õ:õ.====" p7;;,i.;
transfer). 0,
;itiM"..:ii: = ::"*.: ...,;;.=:,' ' 4
1'; 4. .:.;:;a84:i..=
*
.'',... '. ...==4:::4111iiiiiiiiiiiii$iiii.0==::.:i:i.
= ,.:i: 'p ."i..*.;i0'''''': ==:=,:,:iiie
. 6/8 None Small Light-
Fast Excellent immediatÃ
:F.'
-
Moderate drainage. mei
n
Lens was able to sli
around on the suppi
ra
N
C
The lens sometimes
. Mik,3 4.r 1
N
.k....20:07
didn't pop back up v 1 -e--
made dabbing harth
cm
cc
w
---a
C.
49
Attorney Docket No,: VTN6069VVOPCT1
-
:=-= :4', yf
..,:.: -;...., ............... , = ,:::::..;.:.
:
.....
0,.,,,,,,:z...::::4,,: ' . ..
,------..:Zi.,:e::.::
CE6 '.; .4..?...0:::::M::.;;;i:::.t::::: -. 2/5
None Small Light Fast Excellent immediate
Aniiii::::::!'7..,,... .................. ''';,4,;*::.::::-;:::i:941
drainage.
Qii:::....:'...:*/".::;,:.............:::::',:.
'''' ',;:: Lens moved around a lot
"'''...
:...
...0 ..::..:- :........ ,. Lens often caught
on the
,::,...-
1 spokes.
No resistance to dab
made it hard to transfer..
0:0i::::::iiii:::....,::::=::;;:::'''''''''';':;=:' :::: ::44;.'. Lens
apex occasionally P
,
4 .::: ..=.:?,:',õ=.., .....-:"..
....:::::,:....,' ' :.w" "z..
..y.z..::,.:i:i:i:::::,,,.:...... ...,.:,::i:i:i:i;:.=
CE7 /III" , 0/3 None Small-
Moderate Moderat The lens center colli !d
. ...... .
....... , .. ..
,
i,. Aiiiiiiii::.:45' Medium
e onto the hexagonal ,
,
lir,. :..:..:?:'4,...-. '.:'.':.- .... central ring and didr ,
'pop back up,
',-.:0:".:'-., =
The lens didn't mov,
during drainage,
...
1-d
n
,-i
t..,
=
t..,
-
u,
ce,
,.,.,
-.,
cõ
CA 03184193 2022-11-18
WO 2022/054031 PCT/IB2021/058376
Examples 9, 10 and Comparative Example 6 displayed significant lens
movement during opening, which could be improved by providing one or more
positioning guide along the top of one or more of the peripheral supports.
Examples 9
and 10 show that lens supports with only peripheral supports and no central
column can
provide good drainage and lens transfer. Example 10 had an 8 mm gap between
opposite peripheral supports, with one side of the drainage channel extending
to the
center of the support. The lens support of Comparative Example 6 is similar to
that of
Example 10, but without a peripheral support arm extending under the center of
the
lens. The lack of a structure in the center of the lens, caused the lenses to
collapse in
the center during drainage or upon attempted lens transfer, and also provided
insufficient resistance during lens transfer. The ACUVUE Moist lenses used
have a
very low modulus, and lenses with higher moduli, such as silicone hydrogels,
will not
collapse as readily. As is shown by Examples 9 and 10, extending at least one
peripheral support arm under the lens center decreases the collapse of the
lens in the
center, and provides good lens transfer. A flat dome can be designed with
sufficient
surface area to suck the lens to the dome to prevent the lens moving
(Comparative
Example 10) but it also prevents dabbing.
Examples 11-14
Example 7 was repeated varying the diameter of the peripheral ring as shown in
Table 5. The support having a peripheral ring of 16 mm trapped solution
between the
lens and support. The supports with 18 and 25 mm peripheral rings both
provided
good drainage with few reservoirs of trapped packaging solution. While the 16
mm
diameter used in the support for Example 14 was too small for a lens with a
diameter of
14.2 mm, it would be acceptable for a lens with a smaller diameter.
Table 5
Ex. # Ring 1st time
Observations
Diameter dab
(mm)
11 14 2/10 Of the
8 failures 5
transferred on the
51
CA 03184193 2022-11-18
WO 2022/054031 PCT/IB2021/058376
second transfer
attempt.
Very good drainage
but the outer diameter
still seemed stuck to
the ring.
12 16 5/10 Of the 5 failures 3
transferred on the
second transfer
attempt.
13 18. 8/10 Of the 2 failures 2
transferred on the
second transfer
attempt.
14 23 5/10 Of the 5 failures 4
transferred on the
second transfer
attempt
Examples 15-16, Comparative Example 8-10
Several lens support architectures were evaluated to determine support
features
which can provide desirable lens support, package solution drainage and lens
transfer.
Each of the evaluated lens supports was 3D printed on a Form 2, using Formlabs
Formlabs white resin. The lens supports were printed with "L" shaped grips on
opposite sides of the lens support to allow the support and lens to be lowered
and
raised from a packaging solution chamber having dimensions 30mm x 45mm x 25mm.
A 1-Day ACUVUE MOIST contact lens was removed from its package and
placed on each lens support while the support is submerged in packaging
solution to
allow for full wetting, and mounting the lens centered on the support. The
lens support
and lens were submerged in the packaging solution chamber for at least 5
seconds, to
insure is fully submerged with no air bubbles remained under the lens. The
lens holder
was slowly lifted out of the chamber and set on a support of a similar size to
the solution
chamber, but with only two sides to support the grips. The lens holder was
allowed to
drain for about 10 seconds (until the drainage stopped changing) before
evaluating the
drainage and lens transfer. Photographs were taken and evaluated for lens
centration,
areas of fluid trapped between the lens support arms and the lens and lens
deformation.
52
CA 03184193 2022-11-18
WO 2022/054031 PCT/IB2021/058376
To ensure a consistent dab surface and simulate a low adhesion finger, a
rubber
nitrile glove was worn on the hand used for dab testing. The test was repeated
at least
times for each support design, changing out the lens after 2 repeats.
The results are shown in Table 6, along with a representative photograph, and
a
CAD drawing showing the lens support configuration.
53
Attorney Docket No,: VTN6069W0PCT1
Table 6
o
_______________________________________________________________________________
________________________________ w
Ex. Support Representative 1 st Perm Reservoir
Bridges Drainag Observations
w
# Drainage Photo time Films s
e Speed w
Dab
O-
u,
4,.
+ ..........................................
o
CE8 -. . . . . . ---------------------------------------------- 0/2
Severe Large Severe Slow Films form between lens
,-,
and ring and do not
---
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break
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CE9 ---------------------------------------------- 0/5 Moderate
Large Severe Slow Poor drainage
Considerable solution
P
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bridging and reservoirs .
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held lots of solution.
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.. ././.,=::::mgENN
No further drainage E
<-.iiiii:iMf:
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being removed from
i .:ii=.:'4=iiiiii:i:?,
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-4
54
Attorney Docket No,: VTN6069W0PCT1
--------------------------------------------------------------------------
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c,
CA 03184193 2022-11-18
WO 2022/054031 PCT/IB2021/058376
Drainage and hence dabbing are better when a vertical or highly angled fluid
film
is formed between the lens and the drainage reservoir (base of the pack or
test setup)
and breaks before dabbing. Example 15 formed fluid films between the periphery
of the
lens and the lower peripheral ring and drained well. Comparative Example 10
and
Comparative Example 9 did not form vertical films and both drained poorly
despite
having very similar geometry to Example 15. The lens supports of Example 15,
which
had a flat top section and straight side sections with a width at the elbow of
7mm,
provided good drainage with minimal lens-lens support contact, which provided
consistent first-time transfer on finger dabbing (80%).
In cases when the films broke prematurely in Example 15, the lens did not
drain
as well.
Horizontal films are not sufficient for drainage. Films are formed between the
lens
and the outer ring in Comparative Example 8, however the lens still didn't
drain.
Horizontal films also tend to be much more difficult to break, and hence
impede lens
removal.
Examples 17-2 and Comparative Example 11
ACUVUE OASYS 1Day lenses were packaged in polypropylene packages
having the general configuration shown in Figure 5A (polypropylene lid, with
polypropylene lens support affixed to a laminate foil base, having a cavity
volume of
about 1150 pL). The lenses were sealed in the packages with the buffered
solution as
shown in Table 8, steam sterilized for 18 minutes at 121 C with the package
base on
the bottom and lid on top ("foil up"). The lenses were kept at room
temperature in the
foil up configuration. The RMS was for each lens, and the results are shown in
Table
10, below. The number of samples used for each packaging solution is listed in
the
second column of Table 10. The control lenses were ACUVUE OASYS 1Day lenses in
their original unopened packages, which were re-sterilized with the lenses of
Examples
17-20. The RMS values were measured and are reported as the average.
Table 10
56
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Ex. # # PS Volume (pL) RMS (eve) RMS (std
repeats dev)
17 11 1000 0.164 0.054
18 10 1050 0.074 0.050
19 12 1100 0.054 0.050
20 11 1150 0.029 0.008
CE11 15 Control 0.024 0.005
Both the magnitude and variability of the RMS values decreased as the volume
of packaging solution increased to the maximum fill value, and the air bubble
correspondingly decreased. With the dome on top and the lens in the convex
position,
the air bubble rested on and interacted with the optical zone of the contact
lens,
inducing optical distortions as shown by the higher and more variable RMS
values for
Examples 17 and 18. The volume of solution in Example 20 filled the cavity, so
there
was no air bubble to interact with the contact lens, and the Example 20 lenses
show an
average RMS of 0.029 +/- 0.008. Example 19 also displayed acceptable RMS
values,
although they were more variable than the lenses of Example 20. Contact lens
wearers
can notice distortions having RMS values of about 0.1.
Polypropylene will allow some air to diffuse into the package cavity overtime,
so
even if the cavity is filled with packaging solution (no air bubble), and air
bubble can
form during storage. Packages which have foil sheets as the out layers can
prevent the
formation of an air bubble.
The present invention includes the following embodiments/elements/features in
any order and in any combination.
1. A contact lens package comprising
a support for maintaining a contact lens in a convex position on the support
during storage and upon opening the package; wherein
the lens has a peripheral edge and a lens profile;
57
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the support has a profile that does not substantially match the lens profile;
and
wetted contact between the support and the lens is less than about 20 mm2,
less than
18mm2 or less than 15 mm2.
2. A contact lens package comprising
a package base;
a package lid: and
a support for holding, in a convex position relative to the package base; a
contact
lens having a peripheral edge and a lens profile;
wherein the base and lid are sealed to form a cavity comprising the support,
contact lens and packaging solution:
wherein the lens support comprises a plurality of peripheral supports which
have
a distal end extending at least 1 mm beyond the contact lens peripheral edge
and
provide at least 3, 3 to 14, 4 to 14, 3 to 8 or 4 to 8, 4 to 6 or 6 points of
contact with the
contact lens edge along the peripheral supports and wetted contact between the
support and the lens after the package has been opened and the packaging
solution
has been directed away from the lens and support, is less than about 20 mm2,
less than
18mm2 or less than 15 mm2.
3. The contact lens package of claims 1 or 2 wherein the support allows
packaging
solution to drain from the lens and support when removed from the packaging
solution
without trapping packaging solution between the lens and lens support.
4. The contact lens package of claims 1 or 2 wherein the lens further
comprises an
optic zone and the lens support further comprises, under at least a portion of
the contact
lens optic zone, a substantially flat top section with an open structure.
5. The contact lens package of claims I or 2 wherein said support further
comprises a void under at least a portion of the contact lens optical zone.
58
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6. The contact lens package of claims 1 or 2 wherein the contact lens is
maintained
in an uncompressed state when the package is sealed.
7. The contact lens package of claims 1 wherein said support comprises at
least
two peripheral supports.
8. The contact lens package of claim 2 or 7 wherein the peripheral supports
are
distributed around the lens periphery.
9. The contact lens package of any of the foregoing claims wherein the lens
comprises an apex centered in the optic zone, the support further comprising a
central
support having a height, measured from the lens periphery, of not greater than
0.5mm
below the contact lens apex.
10. The contact lens package of claim 9 wherein the central lens support
further
comprises a diameter of about Ito about 10 mm, about 3 mm to about 9mm, about
5
mm to about 9mm, or about 6mm to about 9mm.
11. The contact lens package of claims 9 or 10 wherein the central lens
support has
open structure.
12. The contact lens package of claim 11 wherein said central lens support
comprises a central column under the lens apex.
13. The contact lens package of claim 11 wherein said central lens support
comprises a plurality of arms each arm comprising:
a flat top section, an optional side section and an optional peripheral
support, a shoulder
transition connecting the top and optional side sections, and an optional
elbow transition
connecting the optional side and optional peripheral support.
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14. The contact lens package of claim 13 wherein the plurality of arms in
the flat top
section connect to each other in a center point under the lens apex, or
connect to an
open full or partial ring centered under the lens apex.
15. The contact lens package of claim 13 wherein the plurality of arms are
in the
form of fins connected to the package base.
16. The contact lens package of claim 13 wherein one end of at least some
of the
plurality of arms is attached to the peripheral lens supports and project
upward and
distal ends of the arms form the flat top section.
17. The contact lens package of any of the foregoing claims wherein at
least some of
the distal ends the peripheral supports are connected to vertical supports
which raise
the peripheral supports from the lens base.
18. The package of claims 2 to 17 further comprising at least a partial
ring around the
distal ends of the peripheral supports, at least 2mm beyond the contact lens
peripheral
edge.
19. The package of claim 13 -18 further comprising three to eight arms.
20. The package of claims 13-18 further comprising three to six arms.
21. The package of claim 13-20 wherein at least two of said arms have a Y
shape.
22. The package of claim 13-20 having 3 Y-shaped arms.
23. The package of claim 13-20 comprising 2 straight arms and 2 Y-shaped
arms.
24. The package of claim 21-23 wherein said Y-shaped arms comprise a curve
across a top portion of the Y.
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25. The package of any of claims 13-20 wherein said arms are straight.
26. The package of claim 18 wherein at least partial ring has a diameter of
between
about 16 and about 25 mm, about 18 and about 25 mm or about 18 and about 24
mm.
27. The package of claim 4 wherein said substantially flat top portion has
a height of
0.5 mm, about 0.5 to about 2 mm, 0.5 to about 1.5 mm, or about 0.8 to about
lmm of
deflection from the contact lens apex in an undeformed state.
28. The package of any of claims 9-27 wherein the support further comprises
a
central fillet centered in the flat top section having a width of about 0.1 to
about 3mm;
about 0.1 to about 2mm, or less than 1.5mm across its longest dimension.
29. The package of claims 13-28 wherein each of the arms and peripheral
supports
have a width of about 0.5 to about 1.5mm, about 0.5 mm to about 1 mm, or about
0.5
mm to about 0.7 mm.
30. The package of claims 13 to 29 wherein the arms have a width which
provides
part moldability and efficient packaging solution drainage upon opening.
31. The package of claims 13-30 wherein each arm has a height at the flat
top
section of about 0.5 to about 5 mm.
32. The package of any of claims 9 to 29 wherein the flat top has a center
point in
the center of the lens support and the shoulders are disposed radially around
the flat top
center.
33. The package of claim 32 wherein the arms attach at the center point and
each
arm has a length from the shoulder to the center point of about 1.5 to about 4
mm.
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34. The package of any of the claims 9-33 wherein the angle from vertical
at the flat
top and side sections of the arm is up to about 150, or between about 1 and
about 10 .
35. The package of any of the foregoing claims wherein the angle between
the side
section and the peripheral support is between about 60 and about 120 , or
about 80
and about 100 .
36. The package of any of the foregoing claims wherein the arms connect in
the
center of the flat top portion.
37. Package of any of the foregoing claims wherein the arms are radially
distributed
around the center of the support structure.
38. The package of any of the foregoing claims wherein the base is
substantially flat.
39. The package of any of the foregoing claims wherein the lens does not
contact the
arm side sections.
40. The package of any of the foregoing claims wherein the arm side
sections are
straight.
41. The package of any of the foregoing claims wherein at least one
peripheral
support is elongated and comprises an opening extending distally at or before
the
periphery of the contact lens to form a drainage channel for the drainage of
packaging
solution from the contact lens and support structure.
42. The package of claim 41wherein at least 2 peripheral supports are
elongated and
connected at their distal end with an opening therebetween to form the
drainage
channel.
43. The package of claims 41-42 wherein the partial ring connects to the
elongated
arms.
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44. The package of claims 41-43 wherein the elongated arms are planar.
45. The package of claims 2 wherein the partial ring comprises an outwardly
extending tab with an open drainage channel for the drainage of packaging
solution
from the contact lens and support structure.
46. The package of claims 41 through 45 wherein the drainage channel is
tapered
toward the outwardly extending tab distal end, curved from the peripheral ring
arc to the
distal end, flares out at the peripheral ring arc and taper in from the arc to
the distal end.
47. The package of claims 41 through 45 wherein the drainage channel has
straight
walls.
48. The package of claims 41 through 47 wherein the drainage channel is
about 2.5
to about 3.5 mm in length measured from an arc of the peripheral ring.
49. The package of claims 41 through 47 wherein the drainage channel has a
width
of about 0.8 to about 3mm wide.
50. The package of claims 41 through 47 wherein the drainage channel is
tapered
and has a width of about lmm to about 0.8 mm wide at the distal end.
51. The package of any of the foregoing claims wherein the support is made
from a
polymer having a contact angle of greater than 100C.
52. The package of any of the foregoing claims wherein the lens support is
disposed
at an angle of at least about 20`' from the package base.
53. The package of any of claims 2-52 wherein said peripheral supports are
parallel
to the package base, and at least about 4 mm or at least about 5rnm from said
package
base.
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54. The package of any of the foregoing claims further comprising a means
for lifting
the lens support from the lens solution.
55. The package of claim 54 wherein the lifting means is selected from
levers, springs,
hinges, pivot arms, folds, mechanical traps, handles and combinations thereof.
56. The package of claim 41, 42 or 45 wherein the lifting means comprises
the
drainage channel fixedly attached at the drainage channel distal end to the
package base,
and a hinge line in the package base, transverse to the drainage channel
between the at
least partial peripheral ring or an arc formed by the distal ends of the
peripheral supports
and the fixed attachment point between the drainage channel and package base.
57. The package of claim 56 wherein the hinge line is at least 1 mm, about
2 to about
4mm or about 2.5 to about 3.5 mm in length beyond the at least partial
peripheral ring or
lens periphery if no peripheral ring is included in the lens support.
58. The package of claim 54 wherein the lifting means raises the lens from
the
packaging solution by tilting the lens support and base away from each other
to an angle
of about 15 to about 800, about 20 to about 70 , about 30 to about 60 or
about 40 to
about 60 relative to level.
59. The package of any of the foregoing claims further comprising a
reservoir for
capturing packaging solution when the lens and support are separated from the
package
base.
60. A contact lens package comprising
a support for holding, in a convex position relative to the support, a contact
lens
having a convex surface; and
a lens facing surface comprising at least one air entry guide configured such
that,
upon opening the package by a user, the at least one air entry guide guides
air entering
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the package over the contact lens convex surface to reduce the incidence of
the convex
lens surfaces sticking to the interior surface.
61. The contact lens package of claim 60 wherein the package interior
defines a cavity
comprising the support, at least one air entry guide, contact lens and
packaging solution:
and
upon opening the package and draining the packaging solution from the lens and
the but prior to contact by a user's finger the lens maintains a convex shape
on the lens
support, and the support contacts the lens in at least two points distributed
around the
lens periphery.
62. The package of claims 60 or 61 wherein the lens has a profile and the
support has
a profile that does not substantially match the lens profile.
63. The package of claim 60- 62 wherein the contact area between the
support and
the lens after the package is less than about 20 mm2, less than 18mm2 or less
than 15
mm2.
64. The package any of the foregoing claims wherein the package further
comprises
a base comprising a laminated foil sheet.
65. The package of claims 60-64 wherein contact area between the at least
one air
entry guide and the lens is less than about 50 mm2 or less than about 30 mm2.
66. The package of claims 60-65 wherein the air entry guides are integral
with the lens
facing surface as projections from the lens facing surface, or recesses in the
lens facing
surface.
67. The package of claims 60-65 wherein the air entry guides are part of a
separate
structure disposed between the convex lens surface and the lid lens facing
surface.
CA 03184193 2022-11-18
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68. The package of claims 60-67 wherein the air entry guides are aligned
parallel to a
path air enters upon package opening.
69. The package of claims 60-68 wherein the air entry guides spaced at
least about 2
mm apart, about 2 to about 5 mm apart, or 2 to about 4.5 mm apart.
70. The package of claims 60-69 wherein the contact lens comprises an optic
zone,
and a curved lens side section between the optic zone and the peripheral edge,
and the
air entry guides run in a straight line from the package front to back, curve
around the
optic zone or a combination thereof.
71. The package of claims 70 wherein the air entry guides traversing the
optic zone
have a shorter profile over the optic zone.
72. The package of claims 55-71 wherein the air entry guides comprise
continuous
ribs, discontinuous ribs and combinations thereof.
73. The package of claims 60-72 wherein the air entry guides have a maximum
height
of at least about 2mm, or about 2mm to about 4 mm.
74. The package of claims 71 wherein the air entry guide profile over the
optic zone
has a height of about 0.5mm or less.
J. The package of claims 60-74 wherein said lid facing surface is an
interior surface
of a package lid; and the package further comprises a base, which with the lid
forms the
cavity containing the lens support, lens and packaging solution;
the package further comprising an opening tab for initiating the separation of
the
lid from the base along a seal line forming the cavity, and an air entry scoop
inside the
seal line and in line aligned with the opening tab.
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76. The package of claim 75 wherein the air entry scoop projects out from
the
periphery of the contact lens edge at least about 1 mm or at least about 2mm.
77. The package of claim 75 or 76 wherein the air entry scoop has a width
between
about 2mm and an inner diameter of the seal.
78. The package of claims 75-77 further comprising an opening tab for
initiating the
separation of the lid from the base along a seal line forming the sealed
cavity, wherein
there is at least about 2mm clearance between the seal line and lens support
at the
opening tab.
79. The package of claims 75-78 wherein the air entry tab further comprises
at least
one air entry guide.
80. The package of claims 60 to 79 wherein the lens support, lens facing
surface and
at least one air entry guide cooperate to maintain the lens centered around
the support
with minimal contact between the lens, the support and at least one air entry
guide.
81. The package of claim 80 wherein contact between the lens, the at least
one air
entry guide and the support is transitory.
82. The package of claims 60-81 further comprising an air capture space
away from
the lens optic zone for air in the cavity to occupy.
83. The package of claim 82 where the air remains in the air capture space
away
from the lens regardless of package orientation.
84. The package of claims 82-83 wherein the air capture space has a volume
equal
to or slightly greater than the volume of air to be sealed in the package.
67
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85. The package of claims 82-83 wherein the air capture space has a volume
equal
to or slightly greater than the volume of air sealed in the package, and any
air which
may diffuse into the package during storage.
86. The package of claims 75-85 wherein the lid comprises a concave dome
over the
lens and lens support, the concave dome comprising a depression centered above
the
lens support.
87. The package of claims 82-87 wherein said air capture space comprises a
channel around the circumference of lid, inside the seal.
88. The package of claim 86 where the air capture space is disposed around
the
depression circumference.
89. The package of claim 82-86 wherein the air capture space comprises at
least two
air pods protruding from the lid along the periphery of the lid, inside the
seal.
90. The package of claims 88 further comprising one, two, three or more air
pods
protruding from the lid along the inside of the seal line.
91. The package of claim 88 wherein the air pods are linear, arcuate, or a
combination thereof.
92. The package of claim 90 comprising two planar air pods spaced across
the lid
and oriented parallel or perpendicular to the opening tab.
93. The package of claims 82 through 92 wherein the air pods are connected
via a
connecting channel.
94. The package of claim 93 wherein the air pods are wider, taller or both
wider and
taller than the connecting channel.
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95. The package of claims 93-94 wherein the channel has an interior width
of about
1.5 to about 3 mm, or about 2mm about 3 mm.
96. The package of claims 60 through 95 comprising, when the package is
sealed, at
least about 0.25 mm and about 2 mm clearance between the lens optic zone and
any
air entry guide or dimple.
97. The package of any of the foregoing claims where the base and lid are a
single
unitary part.
98. The package of any of the foregoing claims where the base and lens
support are
a single unitary part.
99. The package of any of the foregoing claims where the base, lens support
and lid
are a single unitary part.
It is to be understood that the present invention is to be determined from the
appended claims and their equivalents.
69
