The field of the invention relates generally to implantable lenses and, more particularly, to implantable lenses having modified edge regions.
As is well known, abnormalities in the human eye can lead to vision impairment. Some typical abnormalities include variations in the shape of the eye, which can lead to myopia (near-sightedness), hyperopia (far-sightedness) and astigmatism as well as variations in the tissue present throughout the eye, such as a reduction in the elasticity of the lens, which can lead to presbyopia. Certain devices, generally referred to as implantable lenses, have been used to successfully treat these and other types of vision impairment.
Implantable lenses typically fall into one of two categories: intraocular lenses (IOLs), which may be implanted deep within the eye to replace the eye's natural crystalline lens, and corneal implants, which are typically implanted near the surface of the eye in the cornea to alter the incident light. Corneal implants, in turn, can be classified as an onlay or an inlay. An onlay is an implant that is placed over the cornea such that the outer layer of the cornea, e.g., the epithelium, can grow over and encompass the implant. An inlay is an implant that is surgically implanted into the cornea beneath a portion of the corneal tissue using, for instance, keratophakia. Example methods of implanting a corneal inlay are described in further detail in co-pending U.S. patent application Ser. No. 10/924,152, filed Aug. 23, 2004, entitled “Method for Keratophakia Surgery,” which is fully incorporated by reference herein.
Because corneal implants are placed within the corneal tissue, a significant concern lies in preventing the tissue from adversely reacting to the implant and creating undesirable conditions. For instance, certain adverse tissue reactions, such as cellular secretions and keratocyte build-up, can lead to an undesirable condition referred to as corneal haze. Corneal haze can obstruct the passage of light through the cornea and the implant and thus prevent proper treatment of the visual impairment. Although corneal haze is multifactorial, there is evidence that it can be influenced, at least in part, by mechanical forces placed on the keratocytes in the corneal tissue.
Furthermore, some corneal implants that are relatively flat around the outer edges, such as aspherical implants and shallow spherical implants to name a few, can suffer from edge lift. Edge lift occurs when the anterior surface of the implant around the outer edge tends to curve or lift back towards the apex.
Accordingly, there is a need for improved implantable lenses that reduce adverse physiological reactions to the presence of the lens and decrease the risk of edge lift.
Embodiments of implantable lenses and methods of manufacturing the same are described in this section as examples only and are not intended to limit the invention. In one example embodiment, an implantable lens is provided having a lens body with an anterior surface, a posterior surface and an edge surface located therebetween. The anterior surface can include a corrective portion and a beveled portion located between the corrective portion and the edge surface. The beveled portion can abut the corrective portion at a first interface and the edge surface at a second interface and the beveled portion can be flat or curved or any other desired shape between the first and second interfaces. The edge surface can abut the beveled portion at a third interface and the posterior surface at a fourth interface and can be flat or curved or any other desired shape between the third and fourth interfaces. The edge surface can include a first portion abutting the beveled portion at the third interface and a second portion abutting the posterior surface at the fourth interface, where the first portion abuts the second portion at a fifth interface. The first portion of the edge surface can be flat, curved or any other desired shape and can converge towards the posterior surface from the third interface to the fifth interface. The second portion of the edge surface can be flat, curved or any other desired shape between the fourth and fifth interfaces.
In another example embodiment, an implantable lens is provided having a body with a first region and a second region, the first region having a first refractive index and the second region having a second refractive index different from the first refractive index. The first region can be permeable to an amount of fluid and nutrients sufficient to substantially sustain tissue adjacent to the body. The second region can have the same permeability as the first region or it can be relatively less permeable than the first region. The first and second regions can provide refractive correction over any distances desired (i.e., near/far, far/near etc.) and can be arranged in any desired manner. The lens can have an anterior surface with any curvature desired and can be configured as a corneal inlay or onlay. In another example embodiment, the first region can be composed of a first polymeric material and the second region can be composed of a second polymeric material, where the first and second regions are integrally coupled together. Any number of regions two or greater can be included as desired with one or more regions integrally coupled together.
Also provided is an example method of manufacturing an implantable lens, where the method includes forming a first core comprising a first polymer having a first refractive index, forming an interface region around at least a portion of the first core, forming a second core comprising a second polymer around at least a portion of the interface region, the second polymer having a second refractive index different than the first refractive index and forming an implantable lens from the first and second cores. The interface region can include a mixture of the first and second polymers and can have a third refractive index different from the first and second refractive indices and can be used to provide additional refractive correction or to serve as a gradual transition between the first and second polymeric regions. The interface region can integrally couple the first and second cores together and can include an interpenetrating network of the first polymer and second polymer.
The example method can also include placing a monomeric solution in contact with the first core, where the first polymer is soluble in the monomeric solution, dissolving a portion of the first core in the monomeric solution such that the monomeric solution and the dissolved portion of the first core mix in the interface region, and polymerizing the mixture of the monomeric solution and the dissolved portion of the first core in the interface region.
In another example embodiment, an implantable lens is provided having a body including a first substantially aspherical surface having a first asphericity (Q) and a second substantially aspherical surface having a second asphericity (Q) different from the first asphericity. The first and second aspherical surfaces can be configured to assist vision at any desired distance or range of distances from the eye and can be arranged in any fashion desired.
Other systems, methods, features and advantages of the invention will be or will become apparent to one with skill in the art upon examination of the following figures and detailed description. It is intended that all such additional systems, methods, features and advantages be included within this description, be within the scope of the invention, and be protected by the accompanying claims. It is also intended that the invention not be limited to the details of the example embodiments.
The details of the invention, including fabrication, structure and operation, may be gleaned in part by study of the accompanying figures, in which like reference numerals refer to like segments.
FIGS. 2C-E are cross-sectional views taken along line 1-1 of
FIGS. 11C-D are cross-sectional views taken along line 3-3 of
FIGS. 12A-D are block diagrams depicting an example method of manufacturing the implantable lens.
FIGS. 14B-C are cross-sectional views taken along line 4-4 of
Described herein are improved implantable lenses with modified edge regions that can reduce stimulation of adverse tissue reactions in proximity to the lens. FIGS. 2A-E depict various views of an example embodiment of implantable lens 100.
As can be seen in FIGS. 2D-E, edge radius 126 preferably slopes in the -Z direction to a greater degree than bevel radius 124, so that edge radius 126 converges towards posterior surface 103 at a greater rate than bevel radius 124. Stated in terms of slope angles, edge radius slope angle 132 is preferably smaller than bevel radius slope angle 135. As a result, lens 100 is less susceptible to edge lift. Also, the gradual transition between spherical portion 122 and posterior surface 103 can reduce stimulation of adverse tissue reactions to lens 100.
For instance,
In order to sustain the cornea 206 and prevent tissue necrosis, an adequate level of fluid and nutrient transfer should be maintained within cornea 206. Accordingly, lens body 101 is preferably composed of a material with a permeability sufficient to allow fluid and nutrient transfer between corneal tissue 207 adjacent to anterior surface 102 and posterior surface 103, in order to sustain the cornea over a desired period of time. For instance, in one example embodiment lens body 101 is composed of a microporous hydrogel material. Microporous hydrogels are described in further detail in U.S. Pat. No. 6,875,232 entitled “Corneal Implant and Method of Manufacture,” which is fully incorporated by reference herein.
TABLE 1 depicts example values for one embodiment of a 5.0 millimeter (mm) diameter lens 100 having a given diopter. These example values are for purposes of illustration only and in no way limit the implantable lens 100 to only these or similar values.
The values of edge thickness 130, edge radius 126, edge slope angle 132 and bevel radius 124 are interdependent and based on the desired corrective values, the overall lens diameter 112, the diameter of corrective portion 122, and the shape of anterior surface 102 and posterior surface 103. Preferably, a lens diameter 112 in the range of about 1-10 mm with a corrective portion diameter 114 of about 0.5 mm or greater will have an edge thickness less than or equal to about 0.015 mm, an edge radius 126 in the range of about 0.001-1 mm, an edge slope angle 132 between 0 and 90 degrees and a bevel radius 124 in the range of about 1-10 mm. These ranges are for illustrative purposes only and in no way limit the embodiments described herein.
It should be noted that the modified edge described herein can be used with any type, shape or configuration of implantable lens. For instance, lens 100 can be either a corneal inlay or onlay. Lens 100 can be configured to treat any visual impairment including, but not limited to, myopia, hyperopia, astigmatism, and presbyopia. Lens 100 can also be configured to treat any combination of visual impairments including, but not limited to, presbyopia with myopia or hyperopia and presbyopia with astigmatism. The overall outer profile 119 of lens 100 can be any shape, including, but not limited to, circular, elliptical, irregular, multi-sided, and shapes having an inner aperture. Outer edge surface 104 can configured with outcroppings such as fixation elements and the like. Also, lens body 101 can be fabricated from one or more different materials having any desired refractive index. Furthermore, as will be described in greater detail below, corrective portion 122 of anterior surface 102 can be substantially spherical with or without multiple focal zones, substantially aspherical with or without multiple aspherical surfaces, or any combination and the like. As used herein, the term substantially is intended to broaden the modified term. For instance, a substantially spherical surface does not have to be perfectly spherical, but can include non-spherical variations or errors and the like to a degree sufficient for implementation.
Beveled portion 124 of anterior surface 102 can be flat or curved or any other desired shape. For instance, in FIGS. 2C-E, beveled portion 124 is spherically curved, however, it should be noted that any type of curve can be used. In the embodiment depicted in
As mentioned above, lens 100 with the modified edge region as described herein can also be implemented as a multifocal lens.
To provide different refractive indices, in one example embodiment regions 402 and 404 are fabricated from different materials integrally coupled together at interface 403. For instance, each region 402 and 404 can be fabricated from different microporous hydrogel materials. In one example embodiment, lens 100 is fabricated by first forming a solid polymeric cylindrical core 502, such as that depicted in
As mentioned above, polymeric core 502 is preferably at least slightly soluble in monomeric solution 503. This is so that solution 503 can dissolve the outer surface of core 502 and become interdispersed and mixed with the dissolved portion of core 502. Once solution 503 is polymerized and solidified, an interface region 505 between cores 502 and 504 can be formed where the different polymers in cores 502 and 504 together form an interpenetrating network. This interface region corresponds to interface region 430 in
The width 420 of interface region 430 can be varied as desired. For instance, to generate a wider interface region 430, monomeric solution 504 can be left in contact with inner core 502 for a longer period of time before polymerization, or, the solubility of inner polymeric core 502 in monomeric solution 504 can be increased. Generally, the wider interface region 430 becomes, the more noticeable region 430 to the subject as a multifocal region.
It should be noted that lens 100 can be fabricated in any manner and is not limited to the example described with respect to FIGS. 12A-D. Other polymerization methods known in the art including, but not limited to, dip coating, spinning, casting, and the polymerization of pre-polymers, can be used in the formation of regions 402 and 404.
In another example embodiment, each region 402 and 404 is configured with varying levels of permeability. For instance, region 402 can have a level of permeability to fluid and nutrients that is sufficient to substantially sustain cornea 206, while region 404 can have a permeability to either fluid or fluid and nutrients that is relatively less than region 402, including being entirely impermeable to fluid and nutrients. This allows for the use of more types of materials having a wider range of refractive indices and/or structural characteristics.
In order to allow enough fluid/nutrient transfer to sustain cornea 206, the size of any impermeable region is preferably minimized. For instance, any circular central region, similar to the embodiment of region 402 described with respect to
Because aspherical surfaces are inherently multifocal, the inclusion of multiple aspherical surfaces provides an added dimension of multifocality to lens 100. For instance, surface 602 can have any asphericity (Q) and can provide a range of diopter values varying at any rate from apex 105 to interface 603 and can be configured to provide for correction over relatively near distances, while surface 604 can have a range of diopter values varying at any rate from interface 603 to interface 123 and can be configured to provide correction over relatively far distances. One of skill in the art will readily recognize that each surface 602 and 604 can have any range of diopter values and provide for correction over any distance.
TABLE 3 depicts example values for one embodiment of a 5.0 millimeter (mm) diameter lens 100 having multiple aspherical surfaces 602 and 604 similar to that depicted in
Although not depicted in FIGS. 14A-C, lens 100 can have one or more transition surfaces at interface 603 that provide for a smoother transition between surfaces 602 and 604, as sharp transitions can stimulate adverse tissue reactions. Edge surface 104 and beveled portion 124 are also not depicted in FIGS. 14A-C, but it can be included as desired. Also, it should be noted that lens 100 can have any number of multifocal surfaces or refractive regions as desired. The multifocal surfaces 602 and 604, substantially spherical or substantially aspherical, can also be arranged in any manner desired including, but not limited to, eccentric, hemispherical, irregular and the like.
In the foregoing specification, the invention has been described with reference to specific embodiments thereof. It will, however, be evident that various modifications and changes may be made thereto without departing from the broader spirit and scope of the invention. For example, each feature of one embodiment can be mixed and matched with other features shown in other embodiments. As another example, the order of steps of method embodiments may be changed. Features and processes known to those of ordinary skill may similarly be incorporated as desired. Additionally and obviously, features may be added or subtracted as desired. Accordingly, the invention is not to be restricted except in light of the attached claims and their equivalents.
This application is a continuation-in-part of U.S. patent application Ser. No. 10/837,402, entitled “Aspherical Corneal Implant” and filed Apr. 30, 2004, which is fully incorporated herein by reference.
Number | Date | Country | |
---|---|---|---|
Parent | 10837402 | Apr 2004 | US |
Child | 11106983 | Apr 2005 | US |