U.S. patent application number 11/937780 was filed with the patent office on 2008-03-13 for contact lens packages.
Invention is credited to John B. Fore, George E. JR. Himes, Mark Mandeville, James M. Peck, Michael G. Tokarski, David C. Turner, Christopher Wildsmith.
Application Number | 20080060950 11/937780 |
Document ID | / |
Family ID | 29999197 |
Filed Date | 2008-03-13 |
United States Patent
Application |
20080060950 |
Kind Code |
A1 |
Peck; James M. ; et
al. |
March 13, 2008 |
CONTACT LENS PACKAGES
Abstract
A package having a roughened surface that does not adhere to a
medical device enclosed therein.
Inventors: |
Peck; James M.;
(Jacksonville, FL) ; Himes; George E. JR.;
(Jacksonville, FL) ; Tokarski; Michael G.; (Ponte
Vedra Beach, FL) ; Wildsmith; Christopher;
(Jacksonville, FL) ; Turner; David C.;
(Jacksonville, FL) ; Fore; John B.; (Travelers
Rest, SC) ; Mandeville; Mark; (Candler, NC) |
Correspondence
Address: |
PHILIP S. JOHNSON;JOHNSON & JOHNSON
ONE JOHNSON & JOHNSON PLAZA
NEW BRUNSWICK
NJ
08933-7003
US
|
Family ID: |
29999197 |
Appl. No.: |
11/937780 |
Filed: |
November 9, 2007 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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11927819 |
Oct 30, 2007 |
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11937780 |
Nov 9, 2007 |
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10458439 |
Jun 10, 2003 |
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11927819 |
Oct 30, 2007 |
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10183133 |
Jun 26, 2002 |
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10458439 |
Jun 10, 2003 |
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Current U.S.
Class: |
206/5.1 |
Current CPC
Class: |
A45C 11/046 20130101;
B65D 75/36 20130101; A45C 11/005 20130101; B65D 2585/545
20130101 |
Class at
Publication: |
206/005.1 |
International
Class: |
A45C 11/04 20060101
A45C011/04 |
Claims
1-4. (canceled)
5. The package of claim 11 wherein the inner surface has an average
roughness of about 1.0 .mu.m to about 20 .mu.m.
6. The package of claim 11 wherein the inner surface has an average
roughness of about 1.8 .mu.m to about 4.5 .mu.m.
7. The package of claim 11 wherein the inner surface has an average
roughness of about 1.9 .mu.m to about 2.1 .mu.m.
8-10. (canceled)
11. A package for storing a contact lens in a solution comprising
(a) a molded base comprising a cavity formed in said molded base
wherein said cavity comprises an inner surface, and a flange
extending outwardly from the periphery of said cavity wherein said
flange comprises a top surface; wherein the base is molded such
that the inner surface of the cavity includes a design comprising a
configuration of raised portions having a surface contact area
defined as the measured surface area of all the raised portions
within the cavity that a contact lens disposed in the cavity can
contact of about 25 percent to about 75 percents of said inner
surface; (b) a flexible cover sheet superimposed over said top
surface of said flange and detachably sealed to said flange at
about the periphery of said cavity to form an enclosure between
said inner surface and said flexible cover, wherein the surface
contact area of said inner surface is about 25 percent to about 75
percents of said inner surface.
12. The package of claim 11 wherein a medical device contained
within said enclosure floats freely in a solution.
13. The package of claim 11 wherein the surface contact area of
said inner surface is about 33 to about 65 percent.
14-23. (canceled)
Description
RELATED APPLICATIONS
[0001] This application is a continuation-in-part of U.S. patent
application Ser. No. 10/183,133, filed on Jul. 26, 2002, now
pending.
[0002] This invention related to packages for storing contact
lenses as well as methods of using and preparing these
packages.
BACKGROUND
[0003] Contact lenses have been used commercially to improve vision
since the 1950s. At first contact lenses were made of hard
materials, which were relatively easy to handle and package for
use, but were uncomfortable for many patients. Later developments,
gave rise to softer more comfortable lenses made of hydrophobic
hydrogels, particularly silicone hydrogels. These lenses are very
pliable, but due to this texture and their chemical composition,
they present a number of problems with packaging.
[0004] Most contact lenses are packaged in individual blister
packages having a bowl portion and a foil top, where the bowl
portion is made from a hydrophobic material such as polypropylene.
See U.S. Pat. Nos. 4,691,820; 5,054,610; 5,337,888; 5,375,698;
5,409,104; 5,467,868; 5,515,964; 5,609,246; 5,695,049; 5,697,495;
5,704,468; 5,711,416; 5,722,536; 5,573,108; 5,823,327; 5,704,468;
5,983,608; 6,029,808; 6,044,966; and 6,401,915 for examples of such
packaging, all of which are hereby incorporated by reference in
their entirety. While polypropylene is resilient enough to
withstand the sterilization steps of contact lens manufacture, this
material has an affinity for contact lenses made of silicone
hydrogels. When silicone hydrogels are packaged in polypropylene
bowls, the lenses stick to the bowl and cannot be removed from the
package without damaging the pliable lenses. Therefore is a need to
prepare a contact lens package that has resilient properties, but
does not stick to the final product. It is this need that is met by
the following invention.
BRIEF DESCRIPTION OF THE DRAWINGS
[0005] FIG. 1 illustrates the top plan view of a contact lens
package.
[0006] FIG. 2 illustrates the side plan view of a contact lens
package
[0007] FIG. 3 illustrates the top plan view the maze
configuration.
[0008] FIG. 4 illustrates the top plan view of radial
configuration.
[0009] FIG. 5 illustrates the top plan the cross hair design
configuration.
[0010] FIG. 6a illustrates the top plan view of the logo
configuration.
[0011] FIG. 6 illustrates the bottom plan view of the logo
configuration.
[0012] FIG. 7 illustrates the top plan view of the spin wheel
configuration.
[0013] FIG. 8 illustrates the top plan view of the ferris wheel
configuration.
[0014] FIG. 9 illustrates the top plan view of the golf ball
configuration.
[0015] FIG. 10 illustrates the top plan view of the sand dollar
configuration.
[0016] FIG. 11, illustrated the top plan view of an enlarged
portion of inner surface of the maze configuration.
DETAILED DESCRIPTION OF THE INVENTION
[0017] This invention includes a package for storing medical
devices in a solution comprising, consisting essentially of, or
consisting of, [0018] (a) a molded base comprising [0019] a cavity
formed in said molded base wherein said cavity comprises an inner
surface, and [0020] a flange extending outwardly from the periphery
of said cavity wherein said flange comprises a top surface; [0021]
(b) a flexible cover sheet superimposed over said top surface of
said flange and detachably sealed to said flange at about the
periphery of said cavity to form an enclosure between said inner
surface and said flexible cover, [0022] wherein said inner surface
has sufficient roughness so that a medical device contained within
said enclosure floats freely in a solution.
[0023] Further, the invention includes a method of reducing the
adherence of a medical device to its package comprising, consisting
essentially of, or consisting of, storing said medical device in a
solution in a package comprising, consisting essentially of, or
consisting of, [0024] (a) a molded base comprising [0025] a cavity
formed in said molded base wherein said cavity comprises an inner
surface, and [0026] a flange extending outwardly from the periphery
of said cavity wherein said flange comprises a top surface; [0027]
(b) a flexible cover sheet superimposed over said top surface of
said flange and detachably sealed to said flange at about the
periphery of said cavity to form an enclosure between said inner
surface and said flexible cover, [0028] wherein said inner surface
has sufficient roughness so that a medical device contained within
said enclosure floats freely in a solution.
[0029] Still further, the invention includes a package for storing
medical devices in a solution comprising, consisting essentially
of, or consisting of, [0030] (a) a molded base comprising [0031] a
cavity formed in said molded base wherein said cavity comprises an
inner surface, and [0032] a flange extending outwardly from the
periphery of said cavity wherein said flange comprises a top
surface; [0033] (b) a flexible cover sheet superimposed over said
top surface of said flange and detachably sealed to said flange at
about the periphery of said cavity to form an enclosure between
said inner surface and said flexible cover, [0034] wherein the
surface contact area of said inner surface is about 25 percent to
about 75 percents of said inner surface.
[0035] Yet, still further, the invention includes a package for
storing medical devices in a solution comprising, consisting
essentially of, or consisting of, [0036] (a) a molded base
comprising [0037] a cavity formed in said molded base wherein said
cavity comprises an inner surface, and [0038] a flange extending
outwardly from the periphery of said cavity wherein said flange
comprises a top surface; [0039] (b) a flexible cover sheet
superimposed over said top surface of said flange and detachably
sealed to said flange at about the periphery of said cavity to form
an enclosure between said inner surface and said flexible cover,
[0040] wherein the surface contact area of said inner surface is
about 25 percent to about 75 percents of said inner surface, and a
medical device contained within said enclosure floats freely in a
solution.
[0041] Even, yet still further, the invention includes a method of
making a molded base comprising [0042] a cavity formed in said
molded base, wherein said cavity comprises an inner surface, and
[0043] a flange extending outwardly from the periphery of said
cavity wherein said flange comprises a top surface; [0044] wherein
said inner surface of said cavity has sufficient roughness so that
a medical device contained within said cavity floats freely in a
solution wherein the method comprises, consists essentially of, or
consists of roughening the mold forming surface of a tool to a
sufficient roughness and forming the mold on said surface of a
tool.
[0045] As used herein a "medical device" is any device that is used
to treat a human condition and is packaged in a solution. Examples
of medical devices include but are not limited to ophthalmic
devices that reside in or on the eye. Ophthalmic devices includes
but are not limited to soft contact lenses, intraocular lenses,
overlay lenses, ocular inserts, and optical inserts. These devices
can provide optical correction or may be cosmetic. The preferred
medical devices of the invention are soft contact lenses made from
silicone elastomers or hydrogels, which include but are not limited
to silicone hydrogels, and fluorohydrogels. Soft contact lens
formulations are disclosed in U.S. Pat. No. 5,710,302, WO 9421698,
EP 406161, JP 2000016905, U.S. Pat. No. 5,998,498, U.S. patent
application Ser. No. 09/532,943, U.S. Pat. No. 6,087,415, U.S. Pat.
No. 5,760,100, U.S. Pat. No. 5,776,999, U.S. Pat. No. 5,789,461,
U.S. Pat. No. 5,849,811, and U.S. Pat. No. 5,965,631. The foregoing
references are hereby incorporated by reference in their entirety.
The particularly preferred medical devices of the invention are
soft contact lenses made from etafilcon A, genfilcon A, lenefilcon
A, polymacon, acquafilcon A, balafilcon A, lotrafilcon A. and
silicone hydrogels as prepared in U.S. Pat. No. 5,998,498, U.S.
patent application Ser. No. 09/532,943, a continuation-in-part of
U.S. patent application Ser. No. 09/532,943, filed on Aug. 30,
2000, U.S. Pat. No. 6,087,415, U.S. Pat. No. 5,760,100, U.S. Pat.
No. 5,776,999, U.S. Pat. No. 5,789,461, U.S. Pat. No. 5,849,811,
and U.S. Pat. No. 5,965,631. These patents as well as all other
patent disclosed in this application are hereby incorporated by
reference in their entirety. The most particularly preferred
medical devices of the invention are soft contact lenses made
acquafilcon A, balafilcon A, or lotrafilcon A.
[0046] The term "solution" refers to any liquid medium in which a
medical device is stored. The preferred solutions are aqueous
solutions contain physiological buffers. The particularly preferred
solution is saline solution. The term "cavity" refers to an
unfilled space suitable for holding a medical device and a
solution. If the medical device is a soft contact lens shape of the
cavity can be, but is not limited to the shape of the cavities in
U.S. Pat. Nos. 4,691,820; 5,054,610; 5,337,888; 5,375,698;
5,409,104; 5,467,868; 5,515,964; 5,609,246; 5,695,049; 5,697,495;
5,704,468; 5,711,416; 5,722,536; 5,573,108; 5,823,327; 5,704,468;
5,983,608; 6,029,808; 6,044,966; and 6,401,915. The term "inner
surface" refers to the surface of the cavity that is adjacent, but
not adhering to the medical device.
[0047] The term "floats freely" refers to the physical interaction
of the medical device with the molded base and the solution. A
medical device floats freely in solution when the molded base
filled with the device and the solution is rotated or jiggled in a
manner where the solution is not spilled and the medical device
contained therein, does not adhere to the inner surface of said
molded base. For example if the medical device is a contact lens
packaged with saline solution, the physical interaction of the
contact lens with its packaging may be tested as follows. The
flexible cover sheet is removed and the molded base is rotated or
jiggled without spilling the saline solution while the contact lens
is observed to determine if it is adhered to the inner surface of
the molded base.
[0048] The term "sufficient roughness" refers to the texture of the
inner surface. Functionally, this surface must be rough enough so
that a medical device immersed in a solution floats freely in said
solution. For example, if the medical device is a contact lens
immersed in a packing solution, particularly a silicone hydrogel
contact lens, said lens floats freely in the packing solution.
[0049] The degree of roughness can be expressed as the average
roughness ("Ra," .mu.m) which is measured by a number of machines
which include but are not limited to Dimension 3000, manufactured
by Digital Instruments, New View 200, manufactured by Zygo
Corporation, and Form Talysurf Series Two, manufactured by Taylor
Hobson Precision. The choice of machine is determined by the
roughness of the surface. For example for surfaces having a surface
roughness of .ltoreq.1.00 .mu.m the Dimension 3000 may be used. For
rougher surfaces, either the New View 200 or the Form Talysurf
Series Two, may be used. Preferably, the Ra of the inner surface is
about 0.2 .mu.m to about 20. .mu.m, more preferably, about 1.8
.mu.m to about 4.5 .mu.m, even more preferably about 1.9 .mu.m to
about 2.1 .mu.m, more preferably still about 0.3 .mu.m to about 0.9
.mu.m, even more preferably about 0.4 .mu.m to about 0.9 .mu.m,
even more still, about 0.5 .mu.m to about 0.8 .mu.m, and most
preferably about 0.6 .mu.m.
[0050] The molded base may be prepared from any number of materials
provided that those materials are compatible with the inspection
and sterilization requirements of device manufacture. Examples of
suitable materials include but are not limited to polypropylene,
polyethylene, nylons, olefin co-polymers, acrylics, rubbers,
urethanes, polycarbonates, or fluorocarbons. The preferred
materials are metallocenes polymers and co-polymers made of
polypropylene, polyethylene, having a melt flow range of about 15
g/10 minutes to about 44 g/10 minutes as determined by ASTM D-1238.
The molded base is formed by any of a number of methods, which
include but are not limited to injection molding, where the surface
of the metal tool that is used to form the molded base is roughened
by glass bead blasting or electron discharge machining ("EDM") to
serve as a template for the roughened inner surface.
[0051] The "flexible cover sheet" can be an adhesive laminate of an
aluminum foil and a polypropylene film or any other extruded or
co-extruded film that can be sealed to the top surface of the
flange in order to form a hermetic seal for the medical device and
the solution. The flexible cover need not be completely sealed to
the entire top surface of the flange and preferably the flexible
cover sheet is sealed an area of the flange that is in close
proximity to the cavity. Further the flexible cover sheet need not
cover the entire top surface of said molded base. As used herein,
the term "forming refers to all suitable methods of preparing of
preparing the molded base, including but not limited to injection
molding and thermal molding. The preferred method of forming the
molded base is injection molding.
[0052] As used herein the term "surface contact area" refers to the
portion of the inner surface that can have physical contact with,
but does not adhere to the medical device. Due to fact that the
medical device floats freely in the packaging, the inner surface
may have areas that are not in contact with the medical device at
all times, particularly when the package is rotated. Therefore, the
surface contact area is measured as a percentage of total inner
surface that can have contact with the medical device, at any time.
The preferred surface contact area is about 33 to about 65 percent
of the inner surface.
[0053] FIG. 1 illustrates the top plan view of one embodiment of
the invention, a contact lens package. Molded base 10, having a
rectangular flange 22, having a top surface 20 and inner surface
13, is shown. The flexible clover sheet 40 (not shown) is
detachably attached to top surface 20 at the raised annular sealing
area 14. FIG. 2 illustrates the side plan view the package having
cavity 30, flexible cover sheet 40 (shown half pulled back), the
packaged contact lens, 17 and solution 18.
[0054] Inner surface 13 may be roughed with glass bead blasting,
EDM or other treatments. For example in order to produce an inner
surface having an Ra of about 1.0 .mu.m to about 2.0 .mu.m, the
tools that are used to form the molds are glass bead blasted on the
appropriate surface. For example in order to produce an inner
surface having an Ra of about 1.0 .mu.M, the tool is blasted at a
pressure of about 40 to about 60 psi for about 20 secs. To produce
an inner surface having an Ra of about 2.0 .mu.m, the tool is
blasted at a pressure of about 60 to about 80 psi for about 20
secs. In order to produce inner surfaces having an Ra 19 .mu.m, a
design is etched on the appropriate surface of the tool using EDM
and the same surface is treated glass bead blasted at about 40 to
about 60 psi.
[0055] In order to produce an inner surface having an surface
contact area of about 30 percent to about 70 percent, a design is
formed on the tool's appropriate surface using EDM. A number of
different designs for inner surface 13 are illustrated in the
following figures. FIG. 3 illustrates the top plan view of inner
surface 13, in the maze configuration. FIG. 4 illustrates the top
plan view of inner surface 13, in the radial configuration. FIG. 5
illustrates the top plan view of inner surface 13, in the cross
hair design configuration. FIG. 6 illustrates the bottom plan view
of inner surface 13, in the logo configuration. FIG. 6a illustrates
the top plan view of inner surface 13, in the logo configuration.
FIG. 7 illustrates the top plan view of inner surface 13, in the
spin wheel configuration. FIG. 8 illustrates the top plan view of
inner surface 13, in the ferris wheel configuration. FIG. 9
illustrates the top plan view of inner surface 13, in the golf ball
configuration. FIG. 10 illustrates the top plan view of inner
surface 13, in the sand dollar configuration. FIG. 11, illustrated
the top plan view of an enlarged portion of inner surface 13 of the
maze configuration. In this figure representative raised portions
41 and recessed portions 43 are illustrated. The surface contact
area of inner surfaces 13 surfaces may be calculated by the
measuring the surface area of all raised portions and recessed
portions of the inner surface.
[0056] When soft contact lenses are prepared the lenses cured to a
hard disc and subsequently hydrated with water to give the
non-sterilized final product. During this hydration step, soft
contact lenses often stick to the surface of the hydration chamber
and it would useful to find a method of hydrating soft contact
lenses which alleviates this problem.
[0057] To solve this problem, the invention includes a method of
hydrating a contact lens comprising, consisting essentially of, or
consisting of hydrating said lens in a molded base wherein said
molded base comprises a cavity formed in said molded base, wherein
said cavity comprises an inner surface wherein said inner surface
of said cavity has sufficient roughness so that a contact lens
contained within said cavity floats freely in a solution.
[0058] Further, the invention includes a method of hydrating a
contact lens comprising, consisting essentially of, or consisting
of hydrating said lens in a molded base wherein said molded base
comprises a cavity formed in said molded base, wherein said cavity
comprises an inner surface wherein the surface contact area of said
inner surface is about 25 percent to about 70 percents of said
inner surface.
[0059] Still further, the invention includes a molded base
comprising, consisting essentially of, or consisting of a cavity
formed in said molded base, wherein said cavity comprises an inner
surface wherein said inner surface has sufficient roughness so that
a medical device contained within said cavity floats freely in a
solution.
[0060] Yet still further, the invention includes a molded base
comprising, consisting essentially of, or consisting of, a cavity
formed in said molded base wherein said cavity comprises an inner
surface wherein the surface contact area of said inner surface is
about 25 percent to about 75 percents of said inner surface.
[0061] Even yet still further, the invention includes a method of
making a molded base comprising a cavity formed in said molded
base, wherein said cavity comprises an inner surface wherein said
inner surface has sufficient roughness so that a medical device
contained within said cavity floats freely in a solution.
[0062] wherein the method comprises, consists essentially of, or
consists of roughening the inner surface. As used herein, the term
"roughening" refers to methods of changing the texture of the inner
surface which include but are not limited to glass bead blasting or
EDM treatment.
[0063] In order to illustrate the invention the following examples
are included. These examples do not limit the invention. They are
meant only to suggest a method of practicing the invention. Those
knowledgeable in contact lenses as well as other specialties may
find other methods of practicing the invention. However, those
methods are deemed to be within the scope of this invention.
EXAMPLES
Example 1
Preparation of Packages with Different Inner Surfaces
[0064] Nickel plated polished inserts were held in a rotating
fixture. The fixture was rotated for a duration of 20 seconds at
one revolution per second and sprayed from an angle of 30 degrees
at a distance of 89 mm with glass beads (Cyclone Glass Bead, 60-100
G, R3893 medium) from a Cyclone 6.500 mm (diameter) nozzle. To
produce a light blast the pressure of the spray is set at 40 psi.
To produce a medium blast, the pressure is set at 60 psi. To
produce a heavy blast, the pressure is set at 80 psi. These inserts
were used to injection mold the base of several different contact
lens packages from polypropylene (Exxon Achieve, PP1605, a
metallocene polypropylene having a melt flow of 32 g/10 minutes,
ASTM D-1238 (L). If the required degree of roughness was not
obtained after one roughening procedure, the inserts were roughened
again.
Example 2
Preparation of Several Designs
[0065] Polished nickel plated inserts were held in a fixture. The
desired designs were produced using a CAD software system and
exported to a computer system of a laser cutting machine. The
insert was attached to a fixture of the laser cutting machine and
the inserts were cut using that machine. After EDM treatment some
inserts were glass bead blasted as well. These inserts were used to
injection mold the base of several different contact lens packages
from polypropylene (Exxon Achieve, PP1605, a metallocene
polypropylene having a melt flow of 32 g/10 minutes, ASTM D-1238
(L).
Example 3
Testing of Contact Lens Packages
[0066] Contact lenses made from acquafilcon A, a silicone hydrogel,
were added to individual polypropylene blister packs having
different inner surfaces containing 950 .mu.L of saline solution
and then the blister pack was heat sealed. Lenses were visually
evaluated for lens' adhesion to the package after sterilization.
The design of the package, the Ra number (.mu.m), percentage of
surface contact area, the number of lenses that stuck to the
package, and number of lenses that were free floating is displayed
in Table 1. TABLE-US-00001 TABLE 1 percent surface Inner Surface
Ra, .mu.m contact area # lenses tested # stuck control 0.139 100 84
84 light blast 0.549 N/A 12 4 medium blast 1.038 N/A 60 2 heavy
blast 1.912 N/A 60 0 maze N/A 65 60 0 cross hair N/A N/A 12 8 spin
wheel N/A N/A 12 8 ferris wheel N/A 2 12 12 sand dollar N/A 11 12
11 golf ball N/A 16 12 9 logo design N/A N/A 12 12 radial design
N/A 33 60 1 maze with 19.1 N/A 60 0 medium blast cross hair with
N/A N/A 60 0 medium blast ferris wheel with N/A N/A 80 0 medium
blast logo with N/A N/A 60 2 medium blast
This table illustrates the ability of a roughened inner surface to
prevent adherence of the lens to its package. The term "N/A" means
not available.
* * * * *