Abstract:
An accommodating intraocular lens comprising a flexible body and flexible optic, and a flexible skirt connecting the optic to the body. The body may have extending loop haptics.

Description:
BACKGROUND  
       [0001]     This application claims priority to U.S. Provisional Application Ser. No. 60/681,115, filed on May 12, 2005. Priority to the prior application is expressly claimed, and the disclosure of the application is hereby incorporated by reference in its entirety. 
     
    
       [0002]     Intraocular lenses have for many years had a design of a single optic with loops attached to the optic to center the lens and fixate it in the empty capsular bag of the human lens. In the mid &#39;80s plate lenses were introduced, which comprised a silicone lens, 10.5 mm. in length, with a 6 mm. optic. These lenses could be folded but did not fixate well in the capsular bag, but resided in pockets between the anterior and posterior capsules. The first foldable lenses were all made of silicone. In the mid 1990s an acrylic material was introduced as the optic of lenses. The acrylic lens comprised a biconvex optic with a straight edge into which were inserted loops to center the lens in the eye and fixate it within the capsular bag.  
         [0003]     Recently accommodating intraocular lenses have been introduced to the market, which generally are modified plate haptic lenses and, like the silicone plate haptic lenses, have no clear demarcation between the junction of the plate with the optic&#39;s posterior surface. A plate haptic lens may be defined as an intraocular lens having two or more plate haptics where combined junctions with the optic represent one quarter or more of the circumference of the optic.  
         [0004]     Flexible acrylic material has gained significant popularity among ophthalmic surgeons. In 2003 more than 50% of the intraocular lenses implanted had acrylic optics. Hydrogel lenses have also been introduced. Both the acrylic and hydrogel materials are incapable of multiple flexions without fracturing.  
         [0005]     The advent of an accommodating lens which functions by moving along the axis of the eye by repeated flexions somewhat limited the materials from which the lens could be made. Silicone is the ideal material, since it is flexible and can be bent probably several million times without showing any damage. Additionally a groove or hinge can be placed across the plate adjacent to the optic as part of the lens design to facilitate movement of the optic relative to the outer ends of the haptics. An example accommodating lens is disclosed in U.S. Pat. No. 6,387,126 in the name of J. Stuart Cumming.  
       SUMMARY OF THE INVENTION  
       [0006]     According to the present invention a new form of accommodating intraocular lens is provided which can be thought of as including a “floating optic piston” with a 360 degree broad and weak skirt essentially allowing the optic to move anteriorly and posteriorly in a piston fashion in response to the pressure gradient created with accommodation.  
         [0007]     Thus, it is a feature of the present invention to provide a new form of accommodating lens. 
     
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0008]      FIG. 1  is a prospective view of the front or anterior side of the lens according to the present invention.  
         [0009]      FIG. 2  is a plan view thereof.  
         [0010]      FIG. 3  is a detailed view of the bottom or posterior side of the lens particularly illustrating ridges to prevent posterior capsular opacification.  
         [0011]      FIG. 4  is a diagrammatic cross-sectional view through the middle of the lens at its thickest part along the short axis to particularly illustrate a vault meter.  
         [0012]      FIG. 5  is an enlarged detailed view of the vault meter.  
         [0013]      FIG. 6A  and  FIG. 6B  are end views of the lens showing two haptic options. 
     
    
     DESCRIPTION OF PREFERRED EMBODIMENT  
       [0014]     Turning now to the drawings,  FIG. 1  is a perspective view of the present lens  10  including a lens body or plate  12  and optic  14 . The body  12  and optic  14  are of silicone or other suitable flexible material. A flexible skirt  16  is between the body  12  and the periphery or outer diameter of the optic  14 . The flexible skirt may be 0.4 mm wide and 0.1 mm thick so as to essentially create an “optic piston”  14 . The optic piston  14  typically can have a diameter of 4.5 mm, a typical width of the lens  10  on the short side is 6.3 mm and the typical length from end to end on the long side is 10.5 mm. The body  12  and optic  14 , as well as outer thickened footplates  20  are formed of silicone or other suitable flexible material. The lens  10  also includes loops  24  of polymide or similar material. The outer loop to loop length is 11.5 mm to 13.0 mm.  
         [0015]     The skirt  16  functions as a pseudo-zonular complex, allowing the optic to move anteriorly and posteriorly. The 0.4 mm wide annular skirt is a point of relative weakness in the plane of the lens encircling the optic  14 , thereby allowing the entire optic  14  to herniate forward (anteriorly) from its far posterior position in a translational forward movement. This feature is enhanced by keeping the mass of the optic  14  to a minimum as described below. This new mechanism may boost the effect of the other features of the lens. Rather than a fluid-filled sac pushing through an aperture as in some prior lenses, the present lens involves a deformable solid optic moving anteriorly through a weak area ( 16 ) and the plate or body  12 .  
         [0016]     Capsular contraction is inevitable in some eyes with any design, and it is not believed to be the case with this lens; however, the lens may be prone to over-vaulting in the event of aggressive capsular contraction syndrome (CCS). Therefore, an optional feature is included which amounts to a thickening of the edge of the plate  12  over the short axis of the lens as indicated at  28  along with a V-shaped opening  30  anteriorly which doubles as a “vault-meter,” indicating the degree of posterior vault. Thus, if the lens begins to bow too posteriorly, the V opening  28  closes and prevents against exaggerated posterior flexure in the event of CCS. The angle of the V opening  30  should be about 50 degrees so as to close and block further vaulting at about 50 degrees of flexure to prevent over-vaulting given that the cord length of the capsular bag shrinks to a minimum of about 8 mm post-op. (Reference: Capsule measuring ring to predict capsular bag diameter and follow its course after foldable intraocular lens implantation. Tehrani M, Dick H B, Krummenauer F, Pfirrmann G, Boyle T, Stoffelns B M; Cataract Refract Surge 2003: 29: 2127-34). There is an additional function of these thickened areas of the plate. They also serve to elevate the anterior capsule away from the optic and from the posterior capsule. This may serve to reduce capsular opacification and contraction.  
         [0017]     Another feature allowing the present lens to accommodate is that the optic  14  can be deformable and constructed with a lower durometer than previously built into any lens. The surrounding plate  12  preferably is made of a higher, standard durometer material, similar to the eyeonics AT45 lens (which is durometer 48). The optic  14  itself is not required to contribute to the structural stability of the lens and, therefore, the optic  14  can be extremely soft. In addition to forward axial translation, the bending or deformation of the optic  14  with accommodation will induce power change. This may result in the bending of the lens to be accentuated. This feature is further enhanced by maintaining the optic very thin since a thinner optic will bend more than a thick optic for any given level of force applied. An example range of optic center thicknesses is about 0.3 mm to 1.1 mm. A 4.5 mm diameter optic  14  and with a reduced edge thickness of 0.1 to 0.2 mm for example can be provided. The index of refraction can be increased and this will accentuate this feature even further. The fact that this optic  14  is symmetrically tethered to the plate  12  in all meridians can mean that power changes in the curvature are also symmetrical, meaning spherical power change as opposed to astigmatic changes found in some other lenses. Optic flexure is a new and poorly understood phenomenon, and optical distortion may be encountered either at near or far distances, in which case the durometer of the material will need to be raised.  
         [0018]     The present lens can be easily foldable with forceps or an injector. A pre-loaded system is preferable.  
         [0019]     Turning to the haptics  24 , these represent a modification of an old C40 IOL design, but it has been altered to allow the lens to fixate in the equator of the capsular bag with complete certainty, but also to be removed or even in the late post-op period by “dialing” (e.g., rotating) the lens out of the capsular bag. The loops  24  may be slightly angulated forward (anteriorly) as seen in  FIGS. 6A-6B , thereby decreasing the likelihood of an anterior vault. This can eliminate the need for cycloplegia post-op. The broad plate  12  structure of the lens  10  allows for excellent protection against vitreous herniation in the event of a YAG centrally or peripherally for CCS. Two optional loop  24  haptics are shown in  FIGS. 6A and 6B .  
         [0020]     An additional feature is the incorporation of a ridge or ridges  40  on the under surface (posterior side) of the plate  12  (or haptic arm as the case may be). These ridges traverse the plate from side to side. The purpose of these ridges is to prevent proliferation of lens epithelial cells behind the plate or haptic. For plate lenses this can dramatically reduce the incidence of capsular contraction as lens equatorial lens epithelial cells will be prevented from migrating under the plate and undergoing a fibrotic contraction. Furthermore, the square edge of the plate haptics protect against cells migrating in from the sides of the plate, but these traversing ridges  40  are the only way to block equatorial cells from migrating centrally under the plates.  
         [0021]     While an embodiment of the present invention as been shown and described, various modifications may be made without departing from the scope of the present invention, and all such modifications and equivalents are intended to be covered.