Note: Descriptions are shown in the official language in which they were submitted.
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HOLDER FOR DUAL OPTIC IOL
Background of the Invention
The present invention relates to devices and methods for holding and/or
packaging optical lenses such as intraocular lenses. More particularly, the
present
invention relates to a holder and/or packaging device and method for safely
supporting
an accommodating intraocular lens device having at least two optics
interconnected by
one or more haptics.
Intraocular lenses having a single optic have been known and used for many
years. More recently, acconunodating intraocular lens devices having two
optics
interconnected by one or more haptics have been disclosed in the following
U.S. patents
and applications to Faezeh Sarfarazi, the entirety of which are incorporated
herein by
reference:
US 5,275,623 "Elliptical Accommodative Intraocular Lens For Small Incision
Surgery";
US 6,423,094 "Accommodative Lens Formed From Sheet Material";
US 6,488,708 "Open Chamber Elliptical Acconiunodative Intraocular Lens
System";
USSN 10/445,762 filed on 5/27/03 entitled "Mold for Intraocular Lens".
The Sarfarazi accommodating lens device includes two optics, one negative and
the other positive for placing in the evacuated lens capsule of an eye. The
optics are
interconnected along their peripheries by one or more haptics which space the
optics
from each other and assist in properly positioning the device in the eye. The
haptics are
formed from a flexible material such that they may flex in response to forces
exerted by
the eye's ciliary muscles which control accommodation. The haptics will thus
flex and
bow further radially outwardly upon a compressive force being applied to the
device,
whereby the two optics are drawn closer together to achieve an accommodative
effect in
the eye. Wlien the ciliary muscles relax, the haptics flex in the opposite
direction (toward
a straightened positioned) causing the optics to space further apart and the
lens device
returns the eye to its natural, unaccommodative state.
As stated above, single optic intraocular lenses have been known and used for
decades while the two lens accommodative intraocular lens device is new and
not yet
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seen on the market. It will be appreciated that manufacturing, packaging and
otherwise
handling a two optic lens device presents issues not present in the
manufacture,
packaging and handling of single optic intraocular lenses. For example, during
design
and manufacture of intraocular lenses, certain measurements and processes may
be
performed on the device to ensure the device achieves its design parameters.
Typically
such measurements and processes require the two optics of the device be held
in their
normally spaced apart condition since contacting of the optical surfaces with
each other
or with parts of the holder could damage the delicate lenses. Likewise,
packaging of a
two optic IOL requires the two optics of the lens remain in their normally
spaced apart
condition and free from contact with any part of the package which could
otherwise
occur due to vibration and forces during transportation and handling.
Summary of the Invention
The present invention provides a holder and/or package for safely supporting a
two optic accommodating intraocular lens device. In a preferred einbodiment,
the holder
acts as the package for storage and shipment of the IOL device to a surgeon.
The
holder/package includes a base with spaced support posts extending
substantially
perpendicularly therefrom which removably support the haptics of the IOL
device. The
posterior optic and anterior optic extend freely therefrom in their normally
spaced
condition and substantially untouched by the holder. In an advantageous
embodiment,
the holder acts as the package for storing and shipping the IOL device to a
surgeon while
maintaining the optics in their spaced condition.
Brief Description of the Drawing
Figure lA is a perspective view of an embodiment of an accommodative
intraocular lens
which may be supported by the holder of the present invention;
Figure 2 is a perspective view of an embodiment of the inventive holder;
Figure 3 is a side elevational view of the holder of Fig. 2 showing the lens
of Fig. 1 and
the cover in spaced relation to the holder base;
Figure 4 is a perspective view of the holder base showing the lens of Fig. 1
spaced above
the support posts thereof;
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Figure 5 is a perspective view the holder base showing the lens of Fig. 1
mounted to the
support posts thereof;
Figure 6 is a side elevational view of Fig. 5;
Figure 7 is a perspective view showing the bottom of the holder base;
Figure 8a is a perspective view of an alternate embodiment of the holder base;
Figure 8b is a cross-sectional view taken generally through the line 8b-8b of
Figure 8a;
Figure 9 is a further alternate embodiment of the holder base; and
Figure 10 is a further alternate embodiment of the holder base and cap.
Detailed Description
Referring now to the drawing, there is seen in Fig. 1 a representative
embodiment
of an accommodative intraocular device 10 which may be used with the present
invention. Briefly, lens device 10 includes first and second optics 12, 14
interconnected
by one or more, but preferably three haptics 16a, 16b and 16c defining three
open spaces
18a, 18b, 18c therebetween, respectively. Haptics 16a-c bow outwardly past the
optic
perimeters 12p, 14p and are flexible whereby the opticsmay move alternately
toward
and away from each other generally along the optical axis x-x. Optics 12, 14
are
preferably flexible and may be made of any suitable IOL lens material such as
silicone,
for example. It is understood that the present invention is a holder/package
for a lens
device and therefore the particular optic and haptic configurations of a lens
device which
may be supported by the inventive holder/package may vary from the exemplary
lens
shown and described herein.
Referring to Figs. 2-7, a preferred embodiment of the holder/package is
indicated
generally by reference numeral 20. Holder/package 20 includes a base 22 and a
removable cover 24 which may be made of any desired material such as plastic.
If the
holder/package is to be used to sterilize the lens 10 held thereby,
holder/package 20
needs to be made of a material that can withstand the sterilization method
employed. For
example, when using ETO sterilization, a plastic such as PVC may be used.
In the preferred embodiment, holder/package base 22 includes first and second
lens supports 26, 28 extending substantially perpendicularly to base 22.
Supports 26, 28
are spaced apart a distance sufficient to enable the mounting of lens 10
thereto in the
manner described below. Supports 26, 28 may have a variety of configurations
but in
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their preferred form include bottom and top segments 26a, 26b and 28a, 26b,
respectively where top segments 26b, 28b are configured with a smaller
diameter than
their respective bottom segments such that a shoulder 26c, 28c is formed at
the juncture
of the top and bottom segments. Shoulders 26c, 28c form a ledge upon which the
downwardly facing edges of haptics 16a and 16b may rest when lens 10 is
mounted to
supports 26, 28. To mount the lens 10 to holder/package 20, lens 10 is
initially
positioned above supports 26, 28 as seen in Figs. 3 and 4 with one haptic 16c
facing
downwardly between supports 26, 28 and haptics 16a, 16b aligned above supports
26,
28, respectively. Lens 10 is then lowered toward base 22 with haptics 16a, 16b
passing
outwardly and over support top segments 26b, 28b until the downward facing
edges
16a', 16b' thereof come to rest on shoulders 26c, 28c, respectively. This
fully mounted
position of lens 10 on supports 26, 28 is seen in Figs. 5 and 6. In this
position, lower-
most haptic 16c is located between and untouched by supports 26, 28. It is
furthermore
preferable that this haptic not contact base 22 which may include an opening
23 between
supports 26, 28 wherethrough haptic 16c may at least partially extend and
freely move
without touching the perimeter of the opening due to the sizing and chamfered
sides
thereof (see Figs. 4-7). Opening 23 may also assist in passage of sterilizing
media (e.g.,
steam) to lens 10.
Although two haptics 16a, 16b are shown and described herein as locating over
supports 26, 28, it is noted that the two haptics may be formed as a single
haptic which
engages the supports 26, 28. As stated previously, the invention is not
limited to the lens
design shown herein and may include one or more haptics of various
configurations as
desired. In this respect, it is noted that the support top segments 26b, 28b
in particular
may have any desired shape and cross-section to more closely conform to the
shape of
the haptic(s) being located thereon.
With lens 10 mounted to supports 26, 28 as described above, optics 12, 14
remain
in their normally spaced position and substantially untouched by
holder/package 12. As
seen best in Fig. 6, support top segments 26b, 28b may be shaped to more
closely
conform to the shape of the facing surfaces of the haptics 16a, 16b mounted
thereon.
More particularly, the outwardly facing surfaces 26b', 28b' of top segments
26b, 26b
may be curved to follow the curvature of the inwardly facing surfaces 16a',
16b' of
haptics 16a, 16b, respectively (see also Fig. 1). As mentioned above, the
spacing of
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supports 26, 28 enable lens 10 to be mounted thereon substantially as shown
and
described herein. In this regard, it is noted that haptics 16a, 16b are
preferably in close
but not overly tight engagement with support top segments 26b, 28b. As such,
lens 10
remains in its normally relaxed condition with optics 12, 14 spaced and lying
substantially perpendicular to base 22. Optics 12, 14 and haptics 16a-c are
preferably
substantially unstressed when mounted to supports 26, 28.
Once lens 10 is mounted to supports 26, 28, cover 24 may be removably secured
to base 22 over lens 10 and supports 26, 28 as seen in Figs. 2 and 3. Cover 24
protects
lens 10 and preferably does not come into substantial contact therewith. The
top portion
25 is attached to a skirt 27 forming a space 29 wherein lens 10 and supports
26, 28 reside
when cover 24 is attached to base 22. The space 29 is large enough to
accommodate lens
and supports 26, 28 therein, yet small enough to prevent lens 10 from
inadvertently
decoupling from supports 26, 28 during handling or shipping. In this regard,
when cover
24 is coupled to base 22, the inside surface of top portion 25 lies in close
proximity to
upper-most parts 16a", l6b" of haptics 16a, 16b (Fig. 6), thereby acting as a
stop
against which haptic parts 16a", 16b" will abut sliould they be urged in a
direction off
of supports 26a, 28b.
In its preferred form, cover top portion 25 is round and skirt 27 is
cylindrical
although other configurations are possible. One or more openings 29a-c may be
provided
in top portion 25 and/or skirt 27 for passage of sterilizing media
therethrough. Releasable
coupling means are provided which may be in the form of first and second
finger
portions 31, 33 extending downwardly from the free edge of skirt 27 which
cooperate
with slots 35, 37 formed in base 22 radially outwardly of supports 26, 28,
respectively.
As seen best in Fig. 7, the free ends 31a, 33a of finger portions 31, 33
extend through
slots 35', 37 upon initial attaching of cover 24 to base 22. Cover 24 is then
rotated until
the finger free ends 31a, 33a engage with the slot shoulders 35a, 37a (Fig. 5)
in the
manner of a bayonet type coupling. To remove cover 24, the cover 24 is simply
rotated
in the opposite direction until the fingers disengage from the slot shoulders
at which time
cover 24 may be raised relative to base 22. Of course other types of removable
coupling
means may be employed.
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A depression 21 or the like may be formed in base 22 to provide a space in
which
lens 12 may be inspected and handled (e.g., with tweezers) once removed from
supports
26, 28.
Figures 8a and 8b show an alternate embodiment of a base 122 having first and
second spaced supports 126, 128 extending substantially perpendicularly from a
base
122. Base 122 includes a central circular portion 122a surrounded by a
circular wall
portion 122b. Supports 126, 128 are spaced from wall portion 122b forming a
space 123,
125 therebetween. Lens device 10 is mounted to base 122 by passing haptics
16a, 16b
over and about supports 126, 128 witli the haptics 16a, 16b coming to rest in
spaces 123,
125, respectively, and optics 12, 141ying in their relaxed, spaced condition.
As seen best
in Fig. 8b, the top extents of the outwardly facing surfaces of haptics 16a,
16b gently
abut wall portion 122b with the bottom extents tliereof gently abutting
supports 126, 128,
respectively, thereby preventing lateral movement of lens device 10 along an
axis
intersecting supports 126, 128. Base 122 thus supports lens device 10 by
capturing the
haptics between the supports and wall portion with the optics 12, 141ying
spaced and
substantially perpendicular to base central circular portion 122a. Central
circular portion
122a may include a through hole 122c to allow passage of sterilizing media
therethrough.
Figure 9 shows yet another alternate embodiment of a base 222 having a unitary
support 226 of generally planar configuration extending substantially
perpendicular to
central base portion 222a. Opposite side edges 226a, 226b are spaced inwardly
of wall
portion 222b which encircles central portion 222a. Support 226 may include a
central
opening 226c to provide clearance between the support 226 and optics 12, 14 of
the lens
device 10. Lens device 10 is mounted thereto by passing haptics 16a, 16b over
and about
opposite side edges 226a, 226b with the lower-most edges of haptics 16a, 16b
coming to
rest at the juncture of side edges 226a, 226b and circular base portion 222a,
respectively.
It is noted that while support 126 is a unitary structure, the opposite side
edges 226a,
226b thereof may be considered as first and second supports, respectively, as
those terms
are used elsewhere herein. The support top edge 226d may be convexly curved to
generally follow the inside contour of haptic 16c resting thereon. When lens
device 10 is
mounted to support 226, optics 12, 141ie spaced and substantially
perpendicular to base
portion 222a.
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Figure 10 is yet a further alternate embodiment of a base 322 having first and
second supports 326, 328 over which haptics 16a, 16b may extend in a manner
similar to
the embodiments of Figures 2-9. One or more posts 330a-d extend substantially
perpendicularly from base 322 on either side of and spaced radially outwardly
of
supports 326, 328. Posts 330a-d act to further guide and control the lateral
movement of
haptics 16a, 16b extending therebetween. An alternate configuration of cap 324
is also
shown.
Although the invention has been described with reference to several
embodiments, it is understood that further variations may be made without
departing
from the full scope of the invention as'defined by the claims which follow.
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