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, accommodating 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:
- U.S. Pat. No. 5,275,623 “Elliptical Accommodative Intraocular Lens For Small Incision Surgery”;
- U.S. Pat. No. 6,423,094 “Accommodative Lens Formed From Sheet Material”;
- U.S. Pat. No. 6,488,708 “Open Chamber Elliptical Accommodative Intraocular Lens System”;
- U.S. Ser. No. 10/445,762 filed on May 27, 2003 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. When 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.
- SUMMARY OF THE INVENTION
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 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.
BRIEF DESCRIPTION OF THE DRAWING
The present invention provides a holder and/or package for safely supporting a two optic accommodating intraocular lens device. In a preferred embodiment, 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.
FIG. 1A is a perspective view of an embodiment of an accommodative intraocular lens which may be supported by the holder of the present invention;
FIG. 2 is a perspective view of an embodiment of the inventive holder;
FIG. 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;
FIG. 4 is a perspective view of the holder base showing the lens of FIG. 1 spaced above the support posts thereof;
FIG. 5 is a perspective view the holder base showing the lens of FIG. 1 mounted to the support posts thereof;
FIG. 6 is a side elevational view of FIG. 5;
FIG. 7 is a perspective view showing the bottom of the holder base;
FIG. 8 a is a perspective view of an alternate embodiment of the holder base;
FIG. 8b is a cross-sectional view taken generally through the line 8 b-8 b of FIG. 8 a;
FIG. 9 is a further alternate embodiment of the holder base; and
FIG. 10 is a further alternate embodiment of the holder base and cap.
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 16 a, 16 b and 16 c defining three open spaces 18 a, 18 b, 18 c therebetween, respectively. Haptics 16 a-c bow outwardly past the optic perimeters 12 p, 14 p and are flexible whereby the optics may 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 their preferred form include bottom and top segments 26 a, 26 b and 28 a, 26 b, respectively where top segments 26 b, 28 b are configured with a smaller diameter than their respective bottom segments such that a shoulder 26 c, 28 c is formed at the juncture of the top and bottom segments. Shoulders 26 c, 28 c form a ledge upon which the downwardly facing edges of haptics 16 a and 16 b 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 16 c facing downwardly between supports 26, 28 and haptics 16 a, 16 b aligned above supports 26, 28, respectively. Lens 10 is then lowered toward base 22 with haptics 16 a, 16 b passing outwardly and over support top segments 26 b, 28 b until the downward facing edges 16 a′, 16 b′ thereof come to rest on shoulders 26 c, 28 c, 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 16 c 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 16 a, 16 b 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 26 b, 28 b 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 26 b, 28 b may be shaped to more closely conform to the shape of the facing surfaces of the haptics 16 a, 16 b mounted thereon. More particularly, the outwardly facing surfaces 26 b′, 28 b′ of top segments 26 b, 26 b may be curved to follow the curvature of the inwardly facing surfaces 16 a′, 16 b′ of haptics 16 a, 16 b, respectively (see also FIG. 1). As mentioned above, the spacing of supports 26, 28 enable lens 10 to be mounted thereon substantially as shown and described herein. In this regard, it is noted that haptics 16 a, 16 b are preferably in close but not overly tight engagement with support top segments 26 b, 28 b. 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 16 a-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 10 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 16 a″, 16 b″ of haptics 16 a, 16 b (FIG. 6), thereby acting as a stop against which haptic parts 16 a″, 16 b″ will abut should they be urged in a direction off of supports 26 a, 28 b.
In its preferred form, cover top portion 25 is round and skirt 27 is cylindrical although other configurations are possible. One or more openings 29 a-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 31 a, 33 a 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 31 a, 33 a engage with the slot shoulders 35 a, 37 a (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.
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.
FIGS. 8 a and 8 b 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 122 a surrounded by a circular wall portion 122 b. Supports 126, 128 are spaced from wall portion 122 b forming a space 123, 125 therebetween. Lens device 10 is mounted to base 122 by passing haptics 16 a, 16 b over and about supports 126, 128 with the haptics 16 a, 16 b coming to rest in spaces 123, 125, respectively, and optics 12, 14 lying in their relaxed, spaced condition. As seen best in FIG. 8 b, the top extents of the outwardly facing surfaces of haptics 16 a, 16 b gently abut wall portion 122 b with the bottom extents thereof 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, 14 lying spaced and substantially perpendicular to base central circular portion 122 a. Central circular portion 122 a may include a through hole 122 c to allow passage of sterilizing media therethrough.
FIG. 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 222 a. Opposite side edges 226 a, 226 b are spaced inwardly of wall portion 222 b which encircles central portion 222 a. Support 226 may include a central opening 226 c 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 16 a, 16 b over and about opposite side edges 226 a, 226 b with the lower-most edges of haptics 16 a, 16 b coming to rest at the juncture of side edges 226 a, 226 b and circular base portion 222 a, respectively. It is noted that while support 126 is a unitary structure, the opposite side edges 226 a, 226 b thereof may be considered as first and second supports, respectively, as those terms are used elsewhere herein. The support top edge 226 d may be convexly curved to generally follow the inside contour of haptic 16 c resting thereon. When lens device 10 is mounted to support 226, optics 12, 14 lie spaced and substantially perpendicular to base portion 222 a.
FIG. 10 is yet a further alternate embodiment of a base 322 having first and second supports 326, 328 over which haptics 16 a, 16 b may extend in a manner similar to the embodiments of FIGS. 2-9. One or more posts 330 a-d extend substantially perpendicularly from base 322 on either side of and spaced radially outwardly of supports 326, 328. Posts 330 a-d act to further guide and control the lateral movement of haptics 16 a, 16 b 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.