U.S. patent application number 14/292322 was filed with the patent office on 2015-04-30 for hydrophilic iol packaging system.
This patent application is currently assigned to Aaren Scientific Inc.. The applicant listed for this patent is Aaren Scientific Inc.. Invention is credited to Robert E. Glick, Stephen Q. Zhou.
Application Number | 20150114855 14/292322 |
Document ID | / |
Family ID | 52993480 |
Filed Date | 2015-04-30 |
United States Patent
Application |
20150114855 |
Kind Code |
A1 |
Glick; Robert E. ; et
al. |
April 30, 2015 |
HYDROPHILIC IOL PACKAGING SYSTEM
Abstract
A method of maintaining a hydrophilic intraocular lens in a
foldable state without immersing the intraocular lens in liquid
water includes the step of storing the foldable intraocular lens
within a substantially air tight package containing a water
reservoir not in direct contact with the lens.
Inventors: |
Glick; Robert E.; (Trabuco
Canyon, CA) ; Zhou; Stephen Q.; (Irvine, CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Aaren Scientific Inc. |
Ontario |
CA |
US |
|
|
Assignee: |
Aaren Scientific Inc.
Ontario
CA
|
Family ID: |
52993480 |
Appl. No.: |
14/292322 |
Filed: |
May 30, 2014 |
Related U.S. Patent Documents
|
|
|
|
|
|
Application
Number |
Filing Date |
Patent Number |
|
|
61895184 |
Oct 24, 2013 |
|
|
|
Current U.S.
Class: |
206/204 ;
206/5 |
Current CPC
Class: |
B65D 81/18 20130101;
A61F 2/1691 20130101; B65D 77/04 20130101; B65D 81/264 20130101;
B65D 1/34 20130101; B65D 43/00 20130101 |
Class at
Publication: |
206/204 ;
206/5 |
International
Class: |
A61F 2/16 20060101
A61F002/16; B65D 43/00 20060101 B65D043/00; B65D 81/18 20060101
B65D081/18; B65D 81/26 20060101 B65D081/26 |
Claims
1. A method of maintaining a hydrophilic intraocular lens in a
foldable state without immersing the intraocular lens in liquid
water, the method comprising the step of storing the foldable
intraocular lens within a substantially air tight package
containing a water reservoir not in direct contact with the
lens.
2. A combination comprising: a) a substantially air tight container
having a water reservoir; and b) a foldable hydrophilic intraocular
lens disposed within the container so as not to be in direct
contact with the water reservoir.
3. The combination of claim 2 wherein the container has interior
surfaces comprising blind holes and wherein the water reservoir
comprises water retained within the blind holes.
4. The combination of claim 2 wherein the container has interior
surfaces with non-smooth textures and wherein the water reservoir
comprises water retained within the surfaces with non-smooth
textures.
5. The combination of claim 2 wherein the container comprises void
volumes and wherein the water reservoir comprises water retained
within the void volumes.
6. The combination of claim 2 wherein the container contains a
water permeable pouch and wherein the water reservoir comprises
water retained within the water permeable pouch.
7. The combination of claim 6 wherein the pouch contains an
absorbent towel and wherein the water reservoir comprises water
retained within the towel.
8. The combination of claim 6 wherein the pouch contains a sheet
having blind holes and wherein the water reservoir comprises water
retained within the blind holes.
9. The combination of claim 6 wherein the pouch contains a water
absorbing polymer and wherein the water reservoir comprises water
retained within the water absorbing polymer.
10. The combination of claim 2 wherein the container comprises a
tray having an elongate compartment bounded by a bottom wall, side
walls and an elongate top opening, the top opening being sealed by
a cover, and wherein the water reservoir comprises water retained
within a water permeable pouch disposed below the cover and
spanning substantially the entirety of the top opening.
11. The combination of claim 10 wherein the container has a
non-permeable foil lid.
12. The combination of claim 2 wherein the container the water
reservoir retains between about 0.5 and 3 ml of water.
13. The combination of claim 2 wherein the combination is disposed
within an autoclavable foil pouch.
14. A combination comprising: a) a substantially air tight
container comprises a tray having an elongate compartment bounded
by a bottom wall, side walls and an elongate top opening, the top
opening being sealed by a cover; comprises water retained within a
water permeable pouch disposed below the cover and spanning
substantially the entirety of the top opening; b) a water reservoir
comprising between about 0.5 and 3 ml of water retained within a
water permeable pouch disposed below the cover and spanning
substantially the entirety of the top opening; and c) a foldable
hydrophilic intraocular lens disposed unfolded within an injector,
the injector being adapted to fold and inject the intraocular lens
into the eye of a patient through a cylindrical injection tube
having an inside diameter of 2 mm or less; wherein, the hydrophilic
intraocular lens is disposed within the container so as not to be
in direct contact with the water reservoir.
15. The combination of claim 14 wherein the pouch contains an
absorbent towel and wherein the water reservoir comprises water
retained within the towel.
16. The combination of claim 14 wherein the pouch contains a sheet
having blind holes and wherein the water reservoir comprises water
retained within the blind holes.
17. The combination of claim 14 wherein the pouch contains a water
absorbing polymer and wherein the water reservoir comprises water
retained within the water absorbing polymer.
18. The combination of claim 14 wherein the combination is disposed
within an autoclavable foil pouch.
Description
RELATED APPLICATION
[0001] This application claims priority from U.S. Patent
Application Ser. No. 61/895,184, entitled "Hydrophilic IOL
Packaging System," filed Oct. 24, 2013, the entirety of which is
incorporated herein by reference.
FIELD OF THE INVENTION
[0002] This invention relates generally to packaging methods and
systems, and more specifically to packaging methods and systems for
foldable intraocular lenses.
BACKGROUND OF THE INVENTION
[0003] IOL polymers can be broadly categorized into two groups: (1)
materials that absorb less than 1 percent water and (2) materials
that absorb more than 1 percent water. Materials that absorb less
than one percent water are typically referred as hydrophobic
polymers. Hydrophobic polymers may be foldable at room temperature.
Their "foldability" results from their composition rather than from
water acting as a plasticizer. Water absorbing polymers are
typically referred to as hydrophilic polymers or hydrogels. The
most common materials in this group have approximately 25 percent
water by weight. Hydrophilic polymers are usually foldable at room
temperature by virtue of absorbed water acting as a
plasticizer.
[0004] The conventional thinking in the intraocular lens (IOL)
industry is that hydrophilic IOLs must be immersed in water or
saline during storage to maintain a level of hydration needed for
foldability at room temperature. Accordingly, lenses composed of
these materials are almost always packaged in normal saline (0.9
percent sodium chloride). Such lenses may reside in saline for up
to five years prior to implantation. The normal saline, in which
these lenses are packaged, is generally designed to mimic the
conditions of the anterior segment of the eye where the lens will
reside following implantation. This means that lenses will have
similar dimension and mechanical characteristics in the eye as they
have in the package where they reside prior to implantation.
[0005] Immersion in water or saline in the presence of other
plastics needed for retention or insertion of the IOL, however, can
result in contamination of the IOL by chemical entities contained
in or produced by other plastic components in the packaging system.
Being immersed in water or saline, the IOL can "communicate" with
plastic components via the liquid phase. Also, when an insertion
instrument is removed from the package for use, water can flow from
where the instrument was stored within the package to the IOL.
[0006] The packaging of IOL' s in water or saline has the
additional disadvantage, especially when the IOL is packaged with
an insertion instrument, of increasing the weight of the package,
thereby increasing shipping costs.
SUMMARY OF THE INVENTION
[0007] The invention avoids the aforementioned problems in the
prior art. In one aspect of the invention, the invention is a
method of maintaining a hydrophilic intraocular lens in a foldable
state without immersing the intraocular lens in liquid water. The
method comprises the step of storing the foldable intraocular lens
within a substantially air tight package containing a water
reservoir not in direct contact with the lens.
[0008] In another aspect of the invention, the invention is a
combination comprising: (a) a substantially air tight container
having a water reservoir; and (b) a foldable hydrophilic
intraocular lens disposed within the container so as not to be in
direct contact with the water reservoir.
DRAWINGS
[0009] These and other features, aspects and advantages of the
present invention will become better understood with reference to
the following description, appended claims, and accompanying
drawings where:
[0010] FIG. 1 is an upper side perspective view of a container
usable in the invention;
[0011] FIG. 2 is a lower side perspective view of the container
illustrated in FIG. 1;
[0012] FIG. 3 is a bottom view of the container illustrated in FIG.
1;
[0013] FIG. 4 is a side view of the container illustrated in FIG.
1;
[0014] FIG. 5 is an end view of the container illustrated in FIG.
1;
[0015] FIG. 6 is a top view of the container illustrated in FIG. 1,
showing retention of an IOL and an IOL injector;
[0016] FIG. 7 is an exploded perspective view of a combination
having features of the invention;
[0017] FIG. 8 is a cross-sectional detail view of a first
distribution enhancer usable in the embodiment illustrated in FIG.
7;
[0018] FIG. 9 is a cross-sectional detail view of a second
distribution enhancer usable in the embodiment illustrated in FIG.
7;
[0019] FIG. 10 is a cross-sectional detail view of a third
distribution enhancer usable in the embodiment illustrated in FIG.
7;
[0020] FIG. 11 is a cross-sectional detail view of a fourth
distribution enhancer usable in the embodiment illustrated in FIG.
7; and
[0021] FIG. 12 is a perspective view of the embodiment illustrated
in FIG. 7 disposed within a foil pouch.
DETAILED DESCRIPTION OF THE INVENTION
[0022] The following discussion describes in detail one embodiment
of the invention and several variations of that embodiment. This
discussion should not be construed, however, as limiting the
invention to those particular embodiments. Practitioners skilled in
the art will recognize numerous other embodiments as well.
Definitions
[0023] As used herein, the following terms and variations thereof
have the meanings given below, unless a different meaning is
clearly intended by the context in which such term is used.
[0024] The terms "a," "an," and "the" and similar referents used
herein are to be construed to cover both the singular and the
plural unless their usage in context indicates otherwise.
[0025] As used in this disclosure, the term "comprise" and
variations of the term, such as "comprising" and "comprises," are
not intended to exclude other additives, components, integers,
ingredients or steps.
The Invention
[0026] In one aspect of the invention, the invention is a method of
maintaining a hydrophilic intraocular lens in a foldable state
without immersing the intraocular lens in liquid water. The method
comprises the step of storing the foldable intraocular lens within
a substantially air tight package containing a water reservoir not
in direct contact with the lens.
[0027] As used within this application, the word "foldable" means
sufficiently pliable to allow the lens to be rolled into a cylinder
with an external diameter sufficiently small to permit the lens to
be injected into the eye of a patient through an injection tube
having a diameter of 2 mm or less. As used herein, the phrase "not
to be in direct contact with the lens" means that the water
reservoir does not immerse more than the outer edges of the
intraocular lens.
[0028] The inventors have discovered the surprising fact that
sufficient hydration of a hydrophilic lens can be maintained to the
extent needed for folding and insertion into an eye without
immersion of the lens in a liquid. In the invention, this is
accomplished by packaging the IOL with water saturated air, or
nearly saturated air. By "nearly saturated" it is meant a humidity
level of at least about 90%, preferably at least 95%. When
saturated, such air cannot accept water from a hydrophilic IOL, and
when nearly saturated, such air can only accept a minimal amount of
water from a hydrophilic IOL. When the air within the container is
nearly saturated and the volume of such air within the container is
minimal (e.g. less than 100 cubic centimeters), the loss of water
from the IOL is unimportantly small.
[0029] Moreover, virtually any cycling of temperature within the
sealed IOL package during storage results in temperatures which
fall below the package interior's dew point and which causes
condensation upon the IOL. Even small decreases in the package
temperature may cause the air within the package to reach its dew
point--thus resulting in condensation on all surfaces with the
package, including on those of the IOL. The presence of water
droplets on the IOL's surfaces assures a level of hydration
adequate for foldability and delivery through a small diameter
tube.
[0030] In a second aspect of the invention, the invention is a
combination 10 comprising: (a) a substantially air tight container
12 having a water reservoir 14; and (b) a foldable hydrophilic
intraocular lens 16 disposed within the container 12 so as not to
be in direct contact with the water reservoir 14. One embodiment of
the combination 10 is illustrated in the drawings.
[0031] FIGS. 1-5 illustrate a substantially air tight container 12
useable in the invention. By "substantially air tight, it is meant
that the container 12 is fully enclosed, but very small amounts of
air may diffuse through the container walls.
[0032] In the embodiment illustrated in FIGS. 1-5, the container 12
comprises a tray 18 having an elongate compartment 20 bounded by a
bottom wall 22, side walls 26 and an elongate top opening 28. In a
typical embodiment, the tray 18 can has a length of about 7.8
inches, a width of about 2.75 inches and a maximum depth of about
1.0 inches.
[0033] The tray 18 can be made from a thermoplastic, such as
polypropylene. In the embodiment illustrated in FIGS. 1-5, the tray
18 can be made from 0.040'' polypropylene.
[0034] In the embodiment illustrated in FIGS. 1-5, the tray 18 has
a circumferential rim 30 with a raised outer lip 32 surrounding a
recessed inner band 34.
[0035] The elongate top opening 28 is sealed by a cover 36. The
cover 36 of the container 12 is typically provided by a foil lid
38, preferably by a multilayered foil lid 38, to minimize the
amount of water lost to diffusion.
[0036] The water reservoir 14 provides an amount of water which
barely exceeds that needed to moisture saturate the interior volume
of the container 12 at temperatures up to those needed for steam
sterilization, as well as to form small water droplets throughout
the container 12. This amount of water should include that which
would be lost over the storage duration due to diffusion through
the walls of the container 12.
[0037] Typically the amount of free water within the container will
range from 0.5 to 3 milliliters of water, such as, for example,
about 1 milliliter.
[0038] The water reservoir 14 can be provided by a variety of one
or more devices. In the embodiment illustrated in FIG. 7, the water
reservoir 14 comprises water retained within a water permeable
pouch 40 disposed below the cover 36. The pouch 40 is designed to
capture and retain water which is only released as "free" water
when atmospheric and other free water within the container 12 is
depleted over time by diffusion through the container walls 22 and
24. Typically, the amount of water captured and retained within the
pouch 40 when the container 12 is initially sealed is between about
5 milliliters and about 20 milliliters. The pouch 40 can be made,
for example, from a Tyvek, a material sold by E. I. du Pont de
Nemours and Company of Wilmington, Del.
[0039] The pouch 40 effectively minimizes humidity variations
throughout the container 12. The pouch 40 may contain distribution
enhancers that facilitate distribution of water over the length and
width of the pouch 40 regardless of the container's orientation. In
one embodiment, the distribution enhancers can be provided by a
towel 42 with wicking or sponge like properties, such as
illustrated in FIG. 9.
[0040] As illustrated in FIG. 10, the distribution enhancers can
also be provided by a piece of plastic 44 that has openings 46 in
the form of blind holes (holes defined in one side of the material
which do not extend through the material and out the opposite side)
that span the surfaces of the tray 18. The blind holes are capable
of retaining free water to saturate the vapor phase within the
container 12.
[0041] As illustrated in FIG. 8, the distribution enhancers can
also be provided by a water absorbing polymer 48, such as polyvinyl
pyrollidone or polymethacrylic acid, having a high water content
that can be released to the atmosphere of the container 12.
Preferably, the water absorbing polymer 48 defines holes 50, such
as blind holes or through holes in which free water can reside.
[0042] As illustrated in FIG. 1, the water reservoir 14 can also be
provided by void volumes 52 within the container 12. The void
volumes 52 are defined separate from the location within the
container 12 of the intraocular lens 16. Preferably, the void
volumes 52 are maximized within the container 12 to minimize the
potential for humidity gradients within the container 12.
[0043] As illustrated in FIG. 11, the water reservoir 14 can also
be provided by blind holes 54 in interior surfaces of the tray
walls 22 and/or 26 where small quantities of free water can reside.
Preferably, the blind holes 54 span a majority of the length and
width of the tray.
[0044] Also as illustrated in FIG. 11, the water reservoir can also
be provided by a non-smooth texture 56 on the interior of surfaces
of the tray walls 22 and/or 26 capable of retaining small amounts
of free water.
[0045] In all cases, the combination 10 is preferably
autoclavable--able to withstand being heated to 121 degrees C. or
more for period of a half hour or more.
[0046] As illustrated in FIG. 12, the combination 10 can be further
sealed within an autoclavable foil pouch 58. Such autoclavable foil
pouch 58 minimizes the amount of water lost to diffusion, provides
a second sterile barrier and allows the container 12 to be
introduced into a sterile field.
[0047] As illustrated in FIGS. 6 and 7, the intraocular lens 16 can
be disposed unfolded within an injector 60, wherein the injector 60
is adapted to fold and inject the intraocular lens 16 into the eye
of a patient through a cylindrical injection tube 62 having an
inside diameter sufficiently small to allow for surgical implanting
of the lens with minimum trauma to the eye. In a typical embodiment
the cylindrical injection tube 62 has a diameter of 2 millimeters
or less.
[0048] Having thus described the invention, it should be apparent
that numerous structural modifications and adaptations may be
resorted to without departing from the scope and fair meaning of
the instant invention as set forth herein above and described
herein below by the claims.
* * * * *