Abstract:
The present invention provides a holder/package for supporting a two optic accommodating intraocular lens device. The holder/package is capable of holding the device, for example while taking measurements or performing manufacturing process steps on the device and/or for packaging and shipping of the device. In a preferred embodiment, the holder/package supports the device along first and second haptics thereof with the optics substantially untouched by the holder/package.

Description:
BACKGROUND OF THE INVENTION  
       [0001]     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.  
         [0002]     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”.    
 
         [0007]     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&#39;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.  
         [0008]     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.  
       SUMMARY OF THE INVENTION  
       [0009]     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. 
     
    
     BRIEF DESCRIPTION OF THE DRAWING  
       [0010]      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;  
         [0011]      FIG. 2  is a perspective view of an embodiment of the inventive holder;  
         [0012]      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;  
         [0013]      FIG. 4  is a perspective view of the holder base showing the lens of  FIG. 1  spaced above the support posts thereof;  
         [0014]      FIG. 5  is a perspective view the holder base showing the lens of  FIG. 1  mounted to the support posts thereof;  
         [0015]      FIG. 6  is a side elevational view of  FIG. 5 ;  
         [0016]      FIG. 7  is a perspective view showing the bottom of the holder base;  
         [0017]      FIG. 8   a  is a perspective view of an alternate embodiment of the holder base;  
         [0018]      FIG. 8b  is a cross-sectional view taken generally through the line  8   b - 8   b  of  FIG. 8   a;    
         [0019]      FIG. 9  is a further alternate embodiment of the holder base; and  
         [0020]      FIG. 10  is a further alternate embodiment of the holder base and cap. 
     
    
     DETAILED DESCRIPTION  
       [0021]     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.  
         [0022]     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.  
         [0023]     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  16 c 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 .  
         [0024]     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.  
         [0025]     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 .  
         [0026]     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.    
         [0027]     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.  
         [0028]     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 .  
         [0029]      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.  
         [0030]      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.    
         [0031]      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.  
         [0032]     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.