Abstract:
Intraocular rings, intraocular lens systems, and associated methods are disclosed. In some instances, the intraocular rings are formed of biocompatible pharmaceutical delivering materials and are configured to be implanted with conventional intraocular lens designs. The intraocular rings include engagement features for interfacing with haptics of the conventional intraocular lens designs in order to ensure proper orientation of the intraocular ring and intraocular lens relative to one another. In some instances, the intraocular rings also include haptics to encourage centering of the intraocular ring within the posterior capsule. The intraocular rings also serve to prevent posterior capsular opacification.

Description:
[0001]    This application claims priority to U.S. Provisional Patent Application Ser. No. 61/356,684 filed on Jun. 21, 2010. 
     
    
     BACKGROUND OF THE INVENTION 
       [0002]    This invention relates generally to the field of intraocular lenses (IOL) and, more particularly, to intraocular rings for use with IOLs. 
         [0003]    The human eye in its simplest terms functions to provide vision by transmitting light through a clear outer portion called the cornea, and focusing the image by way of a crystalline lens onto a retina. The quality of the focused image depends on many factors including the size and shape of the eye, and the transparency of the cornea and the lens. 
         [0004]    When age or disease causes 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. An accepted treatment for this condition is surgical removal of the lens and replacement of the lens function by an artificial IOL. 
         [0005]    The majority of cataractous lenses are removed by a surgical technique called phacoemulsification. During this procedure, an opening is made in the anterior capsule and a thin phacoemulsification cutting tip is inserted into the diseased lens and vibrated ultrasonically. The vibrating cutting tip liquefies or emulsifies the lens so that the lens may be aspirated out of the eye. The diseased lens, once removed, is replaced by an artificial IOL. Often replacement of the lens requires administration of pharmaceuticals to the patient in order to reduce inflammation and/or prevent infection of the eye. Typically, the pharmaceuticals are provided to the patient in the form of eye drops. 
         [0006]    Therefore, there remains a need for improved IOL systems, including systems that incorporate intraocular rings that provide drug delivery capabilities. 
       SUMMARY OF THE INVENTION 
       [0007]    The present disclosure provides intraocular rings and associated lens systems and methods for use in ophthalmic surgery. 
         [0008]    In one embodiment, an intraocular lens system is provided. The intraocular lens system includes an intraocular lens and an intraocular ring. 
         [0009]    The intraocular lens is sized and shaped for implantation into a posterior chamber of an eye and includes a first lens haptic and an opposing second lens haptic. The intraocular ring is sized and shaped for implantation into the posterior chamber of the eye with the intraocular lens. The intraocular ring includes a first recess for receiving the first lens haptic of the intraocular lens and an opposing second recess for receiving the second lens haptic of the intraocular lens. The positioning of the first and second lens haptics within the first and second recesses of the intraocular ring maintains a desired orientation between the intraocular lens and the intraocular ring. The intraocular ring is formed of a biocompatible pharmaceutical-delivering material configured to release a pharmaceutical within the eye after implantation. Accordingly, the intraocular ring provides in vivo drug delivery after implantation. 
         [0010]    In some instances, the intraocular ring further comprises a first ring haptic positioned between the first recess and the second recess and a second ring haptic positioned opposite the first ring haptic. The first and second ring haptics are configured to center the intraocular ring within the posterior chamber of the eye. In some instances, the first and second recesses and the first and second ring haptics are symmetrically spaced about a circumference of the intraocular ring in some embodiments. The intraocular ring includes an annular body portion having an anterior surface, a posterior surface, and a sidewall extending between the anterior surface and the posterior surface. The first and second recesses each comprise a cutout of a portion the posterior surface and a portion of the sidewall. The sidewall defines an inner surface and an outer surface, where the inner surface defines an opening sized to receive the optics of the intraocular lens. Further, the posterior surface of the intraocular ring is configured to prevent posterior capsular opacification in some embodiments. In that regard, the posterior surface of the intraocular ring is substantially planar with squared edges in some instances. 
         [0011]    In some embodiments, at least one of the cutouts has a generally rectangular profile. In some embodiments, at least one of the cutouts has a tapered profile such that a posterior portion of the cutout has a width that is less than an anterior portion of the cutout. The intraocular ring is frosted to diffuse light in some instances. In some embodiments, the intraocular ring does not include haptics. In such embodiments, the first and second lens haptics are utilized to center both the intraocular lens and the intraocular ring within the posterior chamber after implantation. 
         [0012]    In some instances, the intraocular ring is configured to be positioned anteriorly relative to the intraocular lens within the posterior chamber. In some instances, the intraocular ring is configured to be positioned posteriorly relative to the intraocular lens within the posterior chamber. In some embodiments, the intraocular lens is configured to be positioned, at the discretion of medical personnel, either anteriorly or posteriorly relative to the intraocular lens within the posterior chamber. 
         [0013]    In some instances, the biocompatible pharmaceutical-delivering material is an acrylic or silicon based material. In some embodiments, the biocompatible pharmaceutical-delivering material includes an outer pharmaceutical layer formed via vapor deposition. The biocompatible pharmaceutical-delivering material is hydrophilic in some instances. 
         [0014]    In another embodiment, an intraocular ring is provided. The intraocular ring includes an annular body portion having an anterior surface, a posterior surface, and a sidewall extending between the anterior surface and the posterior surface. The sidewall defines an interior circumferential surface and an exterior circumferential surface. A first cutout in the sidewall is sized and shaped to receive a first haptic of an intraocular lens, while a second cutout in the sidewall is sized and shaped to receive a second haptic of the intraocular lens. The engagement of the first and second haptics of the intraocular lens with the first and second cutouts in the sidewall of the annular body portion maintains a relative alignment between the intraocular lens and the annular body portion. The annular body portion is formed of a biocompatible pharmaceutical-delivering material. 
         [0015]    In some instances, the intraocular ring includes a first ring haptic extending from the circumferential exterior surface and positioned between the first cutout and the second cutout and a second ring haptic extending from the circumferential exterior surface and positioned opposite the first ring haptic. The first and second ring haptics are configured to center the annular body portion within a posterior capsular bag. In some instances, the first and second cutouts and the first and second ring haptics are equally spaced about a circumference of the annular body portion. In some embodiments, at least the posterior surface of the annular body portion is configured to prevent posterior capsular opacification. For example, the posterior surface of the annular body portion may be substantially planar with squared edges. In some embodiments, at least one of the first and second cutouts has a generally rectangular profile. In some embodiments, at least one of the first and second cutouts has a trapezoidal profile. 
         [0016]    In another embodiment, a surgical method is provided. The surgical method includes inserting an intraocular lens into a posterior capsular bag of an eye and inserting an intraocular ring into the posterior capsular bag of the eye. The intraocular lens includes a first lens haptic and an opposing second lens haptic. The intraocular ring includes a first recess for receiving the first lens haptic of the intraocular lens and an opposing second recess for receiving the second lens haptic of the intraocular lens. The intraocular ring is formed of a biocompatible pharmaceutical-delivering material configured to release a pharmaceutical within the eye after implantation. The method also includes positioning the first and second lens haptics within the first and second recesses of the intraocular ring to maintain a desired orientation between the intraocular lens and the intraocular ring. In some instances, the steps of inserting the intraocular lens and inserting the intraocular ring are performed simultaneously. In other instances, the step of inserting the intraocular lens is performed prior to or after the step of inserting the intraocular ring such that the intraocular lens is positioned posteriorly or anteriorly relative to intraocular ring. 
         [0017]    Other aspects, features, and advantages of the present disclosure will become apparent from the following detailed description. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0018]    Illustrative embodiments of the present disclosure will be described with reference to the accompanying drawings, of which: 
           [0019]      FIG. 1  is a diagrammatic cross-sectional side view of an eye with an implanted intraocular lens system according to one aspect of the present disclosure. 
           [0020]      FIG. 2  is a perspective top view of an intraocular ring of the intraocular lens system of  FIG. 1 . 
           [0021]      FIG. 3  is a perspective bottom view of the intraocular ring of  FIG. 2 . 
           [0022]      FIG. 4  is a perspective top view of the intraocular lens system of  FIG. 1 , showing the intraocular ring of  FIGS. 2 and 3  engaged with an intraocular lens. 
           [0023]      FIG. 5  is a perspective bottom view of the intraocular lens system of  FIGS. 1 and 4 . 
           [0024]      FIG. 6  is a perspective top view of an intraocular ring according to another aspect of the present disclosure. 
       
    
    
     DETAILED DESCRIPTION 
       [0025]    For the purposes of promoting an understanding of the principles of the present disclosure, reference will now be made to the embodiments illustrated in the drawings, and specific language will be used to describe the same. It will nevertheless be understood that no limitation of the scope of the disclosure is intended. Any alterations and further modifications to the described devices, instruments, methods, and any further application of the principles of the present disclosure are fully contemplated as would normally occur to one skilled in the art to which the disclosure relates. In particular, it is fully contemplated that the features, components, and/or steps described with respect to one embodiment may be combined with the features, components, and/or steps described with respect to other embodiments of the present disclosure. 
         [0026]    Referring to  FIG. 1 , shown therein is an arrangement  100  illustrating aspects of the present disclosure. In that regard,  FIG. 1  is a diagrammatic cross-sectional side view of an eye  102 . The eye  102  includes a cornea  104 , an anterior chamber  106 , and a posterior chamber  108 . A capsular bag  110  is illustrated in the posterior chamber  108 . The eye  102  further includes a retina  112 , including macula  114  and fovea  116 . An intraocular lens system  120  is implanted in the posterior chamber  108 . In particular, the intraocular lens  120  is implanted within the capsular bag  110 . As will be discussed below, the intraocular lens system  120  includes an intraocular ring  122  and an intraocular lens  124 . 
         [0027]    Referring now to  FIGS. 2 and 3 , aspects of the intraocular ring  122  will be discussed in greater detail. In that regard,  FIG. 2  is a perspective top view of the intraocular ring  122  and  FIG. 3  is a perspective bottom view of the intraocular ring. As shown, the intraocular ring  122  includes an annular body portion  126  and haptics  128 . In the illustrated embodiment, the annular body portion  126  includes an anterior surface  130 , an opposing posterior surface  132 , and a sidewall  134  extending between the anterior and posterior surfaces. In that regard, the sidewall  134  defines an interior or inner circumferential surface  136  and an exterior or outer circumferential surface  138 . The annular body portion also includes a cutouts  140  and  142 . In the illustrated embodiment, the cutouts  140 ,  142  are positioned substantially opposite one another about the circumference of the annular body portion. Generally, the cutouts  140 ,  142  are configured to receive haptics of the intraocular lens  124 , as will be discussed in greater detail below with respect to  FIGS. 4 and 5 . As shown, the cutouts  140 ,  142  each have a generally rectangular profile. However, in other embodiments the cutouts  140 ,  142  have other geometrical profiles. Further, while two cutouts are shown, in other instances additional or fewer cutouts may be provided. In that regard, the number of cutouts or recesses in the annular body portion  126  is generally equal to the number of haptic features of the intraocular lens  124  that the intraocular ring  122  is to interface with. 
         [0028]    As shown in  FIG. 3 , the annular body portion  126  has a height  144  between the anterior surface  130  and the posterior surface  132 . Generally, the height  144  is between about 0.5 mm and about 1.0 mm. As shown in  FIG. 2 , the cutout  140  has a height  146  extending between the posterior surface  132  and the anterior boundary of the cutout  140 . Generally, the height  146  of the cutout  140  is sufficient to receive a haptic feature of the intraocular lens  124 . In some instances, the height  146  is between about 25% and about 75% of the height  144  of the sidewall  134 . The cutout  142  has a height that is equal to the height  146  of cutout  140 . In some instances, however, the cutout  142  has a height that is different than the cutout  140 . In the illustrated embodiment, the height  144  is constant about a substantial majority of the circumference of the annular body portion  126  (i.e., all portions other than where the cutouts  140 ,  142  are located). However, in other embodiments the height  144  varies about the circumference of the annular body portion. 
         [0029]    As shown in  FIG. 2 , the sidewall  134  of the annular body portion  126  has a thickness  148  between the interior circumferential surface  136  and the exterior circumferential surface  138 . In some instances, the thickness  148  is between about 0.1 mm and about 1.0 mm. As a general matter, the height  144  and thickness  148  of the annular body portion  126  are sufficiently large to allow the intraocular ring  122  to act as a drug delivery platform (discussed in greater detail below), while still being thin enough to allow capsular bag fusion to occur. 
         [0030]    As illustrated in  FIGS. 2 and 3 , the annular body portion  126  has a circular profile. In that regard, the inner circumferential surface  136  has a diameter between about 6.5 mm and about 10.0 mm in some instances. However, it is understood that the inner circumferential surface  136  may have any diameter suitable for receiving an intraocular lens, or at least the optics of an intraocular lens. 
         [0031]    In some instances, the posterior surface  132  and/or the anterior surface  130  of the annular body portion  126  are configured to prevent posterior capsular opacification (PCO). In that regard, the posterior surface  132  and/or the anterior surface  130  are substantially planar with squared edges, in some instances, to help prevent posterior capsular opacification. 
         [0032]    However, in other instances, the one or both of the surfaces  150 ,  152  have other profiles to reduce or prevent PCO. Further, in some instances, the annular body portion  126  is frosted in order to prevent stray light from reaching the retina in a concentrated manner, which can result in visual disturbances. In that regard, when the annular body portion  126  is frosted it acts as a light diffuser. 
         [0033]    As shown in  FIGS. 2 and 3 , the haptics  128  extend outward from the annular body portion  126 . As a general matter, the haptics  128  are configured to center the intraocular ring  122  within the capsular bag  110 . In the illustrated embodiment, the haptics  128  comprise arms  150 ,  152 . The arms  150 ,  152  are positioned substantially opposite one another such that the arms  150 ,  152  and the cutouts  140 ,  142  are symmetrically spaced about the circumference of the annular body portion  126 . In the illustrated embodiment, the arms  150 ,  152  and the cutouts  140 ,  142  are equally spaced about the circumference such that each feature is separated from each of the two adjacent features by approximately ninety degrees. 
         [0034]    The arms  150 ,  152  have equal lengths to facilitate centering of the intraocular ring  122 . However, in other instances, the arms  150 ,  152  have different lengths. Further, while the haptics  128  of the intraocular ring  122  are illustrated as consisting of the two arms  150 ,  152 , any number of arms or other haptic features may be utilized. In that regard, it is understood that the illustrated haptics  128  are merely for exemplary purposes and in no way limit the number, type, or configuration of haptics utilized by the intraocular rings of the present disclosure. Generally, any type of intraocular haptics may be utilized. Further, as discussed below with respect to the embodiment of  FIG. 6 , in some instances the intraocular rings of the present disclosure do not include any haptics, but rather rely on the haptics of the intraocular lens  124 . 
         [0035]    Referring now to  FIGS. 4 and 5 , the intraocular system  120  is illustrated with the intraocular ring  122  in engagement with the intraocular lens  124 . In that regard,  FIG. 4  is a perspective top view of the intraocular system  120  and 
         [0036]      FIG. 5  is a perspective bottom view of the intraocular system. As shown, the intraocular lens  124  includes an optics portion  160  and haptic arms  162 ,  164  extending outwardly therefrom. It is understood that the intraocular lens  124  and its haptics are only one example of an intraocular lens suitable for use with the intraocular ring  122 . In that regard, the intraocular ring  122  is configured for use with a wide variety of intraocular lenses. For example, the cutouts  140 ,  142  of the intraocular ring  122  allow the intraocular ring to interface with the majority of commercially available intraocular lenses without additional modification to either the intraocular lens or the intraocular ring. However, in some instances aspects of the intraocular ring  122  (e.g., size, shape, and/or location of the cutouts) are tailored to facilitate engagement with haptic features of a particular intraocular lens. 
         [0037]    As shown, the haptic arms  162 ,  164  of the intraocular lens  124  are positioned such that they extend through the cutouts  140 ,  142  of the intraocular ring  122 , respectively. In the illustrated embodiment, the configuration of the haptic arms  162 ,  164  serves to maintain the engagement between the intraocular lens  124  and the intraocular ring  122 . 
         [0038]    To facilitate proper orientation of the intraocular ring  122  and the intraocular lens  124 , one or both of the intraocular ring  122  and the intraocular lens  124  may include markings, an index, and/or other feature(s) to indicate a relative position of the components relative to one another. In that regard, the markings, index, and/or other features can facilitate proper alignment of the haptics of the intraocular lens  124  relative to the openings in the intraocular ring  122  to facilitate proper engagement between the components. In some instances, the geometries of the intraocular ring  122  and the intraocular lens  124  alone provide the necessary indicator(s) for medical personnel to properly align the two components. For example, the haptic arms  150 ,  152  of the intraocular lens, the haptics  128  of the intraocular ring, and/or the cutouts  140 ,  142  of the intraocular ring are utilized to determine the relative orientation of the intraocular ring  122  to the intraocular lens  124  in some instances. In other instances, the geometries of the intraocular ring  122  and the intraocular lens  124  in combination with one or more other features are utilized to properly align the components for engagement with one another. 
         [0039]    In the illustrated embodiment, the intraocular ring  122  is configured to be positioned anteriorly relative to the intraocular lens  124 . In other embodiments, however, the intraocular ring  122  is configured to be positioned posteriorly relative to the intraocular lens  124 . In that regard, the cutouts of the intraocular ring may extend posteriorly from the anterior surface of the intraocular ring, rather than anteriorly from posterior surface as shown in  FIGS. 4 and 5 . 
         [0040]    Referring now to  FIG. 6 , shown therein is an intraocular ring  200  according to another embodiment of the present disclosure. In that regard, intraocular ring  200  is similar to intraocular ring  122  discussed above in many respects. However, intraocular ring  200  does not include haptics. Rather, intraocular ring  200  relies on the haptics of the intraocular lens it is coupled to for proper alignment within the capsular bag. Further, intraocular ring  200  illustrates an alternative cutout configuration for receiving the haptics of the intraocular lens. In that regard, the intraocular ring  200  has a posterior surface  230 , an anterior surface  232 , and sidewall  234  extending therebetween. The intraocular ring also includes tapered cutouts  240 ,  242  to help prevent unwanted disengagement of the intraocular ring from the haptics of the intraocular lens. As shown, the width of the cutouts  240 ,  242  increases at it extends inwardly into the sidewall  234  of the intraocular ring  200  from the anterior surface  232 . Accordingly, the cutout has a first, narrower width adjacent the anterior surface  232  and a second, wider width at its posterior boundary. In some instances, the width is between 10% and 150% greater at the posterior boundary of the cutout than the width adjacent the posterior surface. The illustrated cutouts  240 ,  242  have a generally trapezoidal shape. However, other tapered cutout configurations are used in other embodiments, including arcuate tapered configurations. 
         [0041]    Generally, the intraocular rings of the present disclosure may be formed of any suitable biocompatible pharmaceutical-delivering material. For example, in some instances the lenses are formed of a soft acrylic polymer (e.g., a material used to form commercially available lenses sold by Alcon under the trademark Acrysof®) embedded and/or coated with a pharmaceutical. In that regard, all or a portion of the surfaces of the rings may be embedded or coated with the pharmaceutical. In some instances, the exterior or outer circumferential surfaces are embedded and/or coated with the pharmaceutical, while the anterior and/or posterior surface(s) are not embedded or coated with the pharmaceutical. The intraocular rings of the present disclosure may be formed of the materials disclosed in U.S. Pat. No. 6,416,550, which is hereby incorporated by reference in its entirety, including embedding and/or coating the disclosed materials with a pharmaceutical. 
         [0042]    In other embodiments, the intraocular rings are formed of other suitable biocompatible materials, such as a silicone or hydrogel, that have been embedded and/or coated with a pharmaceutical. In some instances, the haptics of the intraocular rings are formed of a different material than the annular body portion. In such instances, the haptics may be formed of suitable polymeric materials, such as polymethylmethacrylate, polypropylene and the like, with or without pharmaceutical embedding and/or coating. 
         [0043]    It is understood that any suitable intraocular pharmaceutical(s) may be embedded into and/or coated onto the intraocular rings of the present disclosure. In that regard, one or more of an anti-inflammatory, anti-biotic, pro-biotic, anti-fungal, anti-bacterial, anti-viral, anti-allergenic, hormone, growth factor, analgesic, other therapeutic agent, and combinations thereof may be utilized. Pharmaceutical, as that term is utilized in the present disclosure, is understood to include any chemical, compound, material, solution, drug, or medicine suitable for use within the eye. Further, a single pharmaceutical may be utilized or a combination of two or more pharmaceuticals may be utilized. In that regard, where two or more pharmaceuticals are utilized the pharmaceuticals may be configured to be released simultaneously and/or in a staggered fashion (i.e., one pharmaceutical at a time). Layering of the pharmaceuticals can be used to control the relative timing of the release. For example, if it is desirable to release a first pharmaceutical before a second pharmaceutical, then the first pharmaceutical can be deposited over the second pharmaceutical such that the second pharmaceutical is not released until after the first pharmaceutical has been released to expose the second pharmaceutical. On the other hand, if it is desirable to release the first pharmaceutical simultaneously with the second pharmaceutical, then the first and second pharmaceuticals may be form discrete portions of a layer and/or be interspersed to form the layer. Combinations of single and/or multiple pharmaceutical layers may be utilized to produce the desired release of pharmaceuticals from the intraocular ring. 
         [0044]    In some instances, the intraocular rings and/or the intraocular lenses are foldable to facilitate insertion using minimally invasive surgical techniques. In particular, the intraocular rings and/or intraocular lenses may be configured to be inserted through an incision having a length less than 4.0 mm and, in some instances, less than 3.5 mm. Further, the intraocular ring and intraocular lens may be inserted separately or together. For example, in one embodiment the intraocular lens is first inserted into the capsular bag and then the intraocular ring is inserted into the capsular bag and engaged with the posterior lens. In another embodiment, the intraocular lens is engaged with the intraocular ring and the lens and ring are inserted into the capsular bag together. In some instances, the capsular bag is shrink-wrapped around the intraocular ring and intraocular lens after implantation to securely engage the system. Further, in some embodiments, the size and shape of the combination of the intraocular ring and intraocular lens helps prevent interlenticular cell growth. In that regard, in some instances shrink-wrapping the capsular bag around the intraocular ring and intraocular lens seals off the circumferential space around the system to prevent interlenticular cell growth. 
         [0045]    Although illustrative embodiments have been shown and described, a wide range of modification, change, and substitution is contemplated in the foregoing disclosure. It is understood that such variations may be made to the foregoing without departing from the scope of the present disclosure. Accordingly, it is appropriate that the appended claims be construed broadly and in a manner consistent with the present disclosure.