Abstract:
An intraocular lens cartridge having a distal injector portion and a proximal shipping portion. The injector portion and the shipping portion are join be a hinge that allows the shipping portion to be rotated so that the lens, when held in the shipping portion, aligns with the bore of the injector portion. The shipping portion may also be flexible so as to provide a prefold to the lens.

Description:
[0001]    This invention relates to intraocular lenses (IOLs) and more particularly to cases and cartridges used to ship and inject IOLs into an eye.  
         BACKGROUND OF THE INVENTION  
         [0002]    The human eye in its simplest terms functions to provide vision by transmitting and refracting light through a clear outer portion called the cornea, and further focusing the image by way of lens onto the retina at the back of the eye. The quality of the focused image depends on many factors including the size, shape and length of the eye, and the shape and transparency of the cornea and lens.  
           [0003]    When trauma, age or disease cause the lens to become less transparent, vision deteriorates because of the diminished light which can be transmitted to the retina. This deficiency in the lens of the eye is medically known as a cataract. The treatment for this condition is surgical removal of the lens and implantation of an artificial lens or IOL.  
           [0004]    While early IOLs were made from hard plastic, such as polymethylmtharcrylate (PMMA), soft foldable IOLs made from silicone, soft acrylics and hydrogels have become increasingly popular because of the ability to fold or roll these soft lenses and insert them through a smaller incision. Several methods of rolling or folding the lenses are used. One popular method is an injector cartridge that folds the lenses and provides a relatively small diameter lumen through which the lens may be pushed into the eye, usually by a soft tip plunger. The most commonly used injector cartridge design is illustrated in U.S. Pat. No. 4,681,102 (Bartell), the entire contents of which is incorporated herein by reference, and includes a split, longitudinally hinged cartridge. Similar designs are illustrated in U.S. Pat. Nos. 5,494,484 and 5,499,987 (Feingold) and U.S. Pat. Nos. 5,616,148 and 5,620,450 (Eagles, et al.), the entire contents of which are incorporated herein by reference. In an attempt to avoid the claims of U.S. Pat. No. 4,681,102, several solid cartridges have been investigated, see for example U.S. Pat. No. 5,275,604 (Rheinish, et al.) and U.S. Pat. No. 5,653,715 (Reich, et al.), the entire contents of which are incorporated herein by reference.  
           [0005]    These prior art cartridges are not suitable for sterilizing or shipping the IOL, and all currently available IOLs that use injection cartridge are shipped in a separate case and must be transferred to the cartridge prior to injection. This requires extra handling by the surgical staff in the operating room.  
           [0006]    Accordingly, a need continues to exist for an IOL injector cartridge that can also be used as a shipping case.  
         BRIEF SUMMARY OF THE INVENTION  
         [0007]    The present invention improves upon prior art injector cartridges by providing a cartridge having a distal injector portion and a proximal shipping portion. The injector portion and the shipping portion are join be a hinge that allows the shipping portion to be rotated so that the lens, when held in the shipping portion, aligns with the bore of the injector portion. The shipping portion may also be flexible so as to provide a prefold to the lens.  
           [0008]    It is accordingly an object of the present invention to provide a lens injector cartridge that can be used to both ship the lens and inject the lens into the eye.  
           [0009]    It is a further object of the present invention to provide a lens injector cartridge that generally folds the lens.  
           [0010]    It is a further object of the present invention to provide a lens injector cartridge that minimizes the potential for damage to the optics and/or the haptics.  
           [0011]    Another objective of the present invention is to provide a lens injection cartridge having a distal injector portion and a proximal shipping portion.  
           [0012]    Other objects, features and advantages of the present invention will become apparent with reference to the drawings, and the following description of the drawings and claims. 
       
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0013]    FIGS.  1 A- 1 C are top plan views of a first embodiment of the cartridge of the present invention.  
         [0014]    FIGS.  2 A- 2 C are side elevational views of a second embodiment of the cartridge of the present invention.  
         [0015]    [0015]FIG. 3A is a cross-sectional view of the first embodiment of the cartridge of the present invention.  
         [0016]    FIGS.  4 A- 4 D are a top plan views of one embodiment of the cartridge/handpiece combination of the present invention delivery a lens.  
         [0017]    FIGS.  5 A- 5 B are rear elevational views of the shipping portion of the cartridge of the present invention being installed into a handpiece.  
         [0018]    FIGS.  6 A- 6 B are rear elevational views of the shipping portion of the cartridge of the present folding a lens manually. 
     
    
     DETAILED DESCRIPTION OF THE INVENTION  
       [0019]    As best seen in FIGS.  1 A- 1 C and  2 A- 2 B, intraocular lens injector cartridge  10  and  110  of the present invention generally has injector portion  11 , and  111  and shipping portion  13  and  113 . Injector portion  11  and  111  generally include tubular body  12  and  112  and injection nozzle  14  and  114 , respectively. Injector portion  11  and  111  and shipping portion  13  and  113  are connected by hinge  15  and  115 , respectively. Cartridge  10  and  110  preferably are molded as a single piece from any suitable thermoplastic, such as polyproplyene, and the thermoplastic may contain a lubricity enhancing agent such as those disclosed in U.S. Pat. No. 5,716,364, the entire contents of which are incorporated herein by reference. Nozzles  14  and  114  preferably are rounded, oval or elliptical in cross-section and has a cross-sectional area of preferably between 1.0 mm 2  to around 6.5 mm 2  at distal tip  15  and  115 . Distal tip  15  and  115  of nozzle  14  and  114  preferably is rounded on the interior and exterior. Body  12  and  112  preferably contain grips  17  and  117  that allow easier manipulation of cartridge  10  and  110  and provide a mechanism to lock cartridge  10  and  110  in the injection handpiece  200 . Suitable designs for injector portion  11  and  111  of cartridge  10  and  110  are illustrated in U.S. Pat. Nos. 5,947,976, 6,083,231 and 6,143,001, the entire contents of which are incorporated herein by reference. Shipping portion  13  may contain ridge or protuberance  21  that allows for the folding or tucking of trailing haptic  23  over IOL  20 , as seen in FIG. 1C.  
         [0020]    In order to facilitate further the movement of IOL  20  down bore  18 , interior surface  19  of bore  18  may be coated with a lubricous coating such as those described in U.S. Pat. Nos. 4,487,865, 4,500,676, 4,663,233, 4,801,475, 4,959,074, 5,023,114 and 5,037,677, the entire contents of which are incorporated herein by reference. Bore  18  may also be coated by any commercially available medical grade viscoelastic, such a VISCOAT® viscoelastic available from Alcon Laboratories, Inc., Fort Worth, Tex. The inventors have also found that texturizing interior surface  19  also assists in the movement of IOL  20  down bore  18  by minimizing the amount of surface contact between interior surface  19  and IOL  20  and by entrapping any viscoelastic agent between interior surface  19  and IOL  20 . For example, a surface roughness of greater than 0.45 microns RMS may be used. Such a finish can be generated by a two step process incorporating an initial random pattern texture by sandblasting or acid etching followed by a specific directional polish along the longitudinal axis of bore  18  in order to achieve a cropped or plateau effect.  
         [0021]    As best seen in FIGS.  5 A- 5 B, shipping portion  13  (and shipping portion  113 , not shown) is design so as to hold IOL  20  firmly and in a relatively relaxed state during sterilization and shipping, for example, by the use of sockets  22 . As best seen in FIGS. 1 and 2, when shipping portion  13  and  113  are rotated about hinge  15  and  115 , respectively, IOL  20  aligns with bore  18  in body  12  of cartridge  10 , and with the bore (not shown) in body  112  of cartridge  110 . Cartridge  10  or  110  may then be loaded into handpiece  200 . As best seen in FIGS.  5 A- 5 C, handpiece  200  may contain tabs  210  that align with detents  212  in shipping portion  13  so as to collapse partially shipping portion  13  and hold lens  20  in a slightly pre-folded condition. Additional folding occurs as lens  20  travels down tapering nozzle  11  or  114 . As best seen in FIGS.  4 A- 4 D, lens  20  may then be easily pushed through cartridge  10  or  110  by plunger  300  of handpiece  200  and expressed out distal tip  15  of nozzle  14  (or distal tip  115  of  114 ). Handpiece  200  may contain a feature, such as clasp  216  that hold shipping portion  13  or  113  tightly against shipping portion  11  or  111 , respectively. As shown in FIGS.  4 A- 4 D, cartridge  10  or  110  and handpiece  200  may be integrally made as a single piece injector. Alternatively, cartridge  10  and  110  may be made separately from handpiece  200 , as shown in FIGS.  1 - 3 , with handpiece  200  being any suitable design, such as that shown in U.S. Pat. No. 6,010,510, the entire contents of which being incorporated herein by reference.  
         [0022]    As best seen in FIGS.  6 A- 6 B, shipping portion  13  or  113  may alternatively be used to fold lens  20  manually, without the use of handpiece  200 , by squeezing together sides  19  of shipping portion  13  or  113  so as to fold lens  20 . Folded lens  20  may then be removed by forceps  21 .  
         [0023]    While certain embodiments of the present invention have been described above, these descriptions are given for purposes of illustration and explanation. Variations, changes, modifications, and departures from the systems and methods disclosed above may be adopted without departure from the scope or spirit of the present invention.