Intraocular lens with elastic mask

Information

  • Patent Grant
  • 10548717
  • Patent Number
    10,548,717
  • Date Filed
    Monday, June 25, 2018
    6 years ago
  • Date Issued
    Tuesday, February 4, 2020
    4 years ago
Abstract
Intraocular implants and methods of making intraocular implants are provided. The intraocular implant can include a lens body having a lens material and a mask having a mask material. The lens body can be secured to the mask. The mask material can include a modulus of elasticity that is greater than or equal to a modulus of elasticity of the lens material.
Description
BACKGROUND
Field

This application relates generally to the field of intraocular devices. More particularly, this application is directed to intraocular implants and lenses (IOLs) with an aperture to increase depth of focus (e.g. “masked” intraocular lenses), and methods of making the same.


Description of the Related Art

The human eye functions to provide vision by transmitting and focusing light through a clear outer portion called the cornea, and further refining the focus of the image onto a retina by way of a crystalline lens. 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.


The optical power of the eye is determined by the optical power of the cornea and the crystalline lens. In a normal, healthy eye, sharp images of distant objects are formed on the retina (emmetropia). In many eyes, images of distant objects are either formed in front of the retina because the eye is abnormally long or the cornea is abnormally steep (myopia), or formed in back of the retina because the eye is abnormally short or the cornea is abnormally flat (hyperopia). The cornea also may be asymmetric or toric, resulting in an uncompensated cylindrical refractive error referred to as corneal astigmatism.


Some people suffer from cataracts in which the crystalline lens undergoes a loss of transparency. In such cases, the crystalline lens can be removed and replaced with an intraocular lens (IOL). However, some intraocular lenses may still leave defects in a patient's non-distance eyesight.


SUMMARY

Certain aspects of this disclosure are directed toward an intraocular lens including a mask embedded within, or secured to, a lens body including a lens material. The mask can include an aperture for improving depth of focus. Further, the mask can include a mask material having a modulus of elasticity that is within about 30 percent of a modulus of elasticity of the lens material.


Certain aspects of this disclosure are directed toward an intraocular lens including a mask embedded within, or secured to, a lens body including a lens material. The mask can include an aperture for improving depth of focus. Further, the mask can include a mask material having a coefficient of thermal expansion that is within about 30 percent of the coefficient of thermal expansion of the lens material. In some embodiments, the mask material has a coefficient of thermal expansion that is within about 20 percent, within about 10 percent, or within about 5 percent of the coefficient of thermal expansion of the lens material.


In any of the above mentioned aspects, the intraocular lens can be configured such that a pre-injection optical power of the intraocular lens can be within about 0.5 diopters, preferably within about 0.3 diopters, or within about 0.2 diopters, or within about 0.1 diopters, of a post-injection optical power of the intraocular lens.


In any of the above mentioned aspects, the modulus of elasticity of the mask material can be within about 20 percent of the modulus of elasticity of the lens material, or within about 10 percent of the modulus of elasticity of the lens material, or within about 5 percent greater than the modulus of elasticity of the lens material. In some embodiments, the modulus of elasticity of the mask material can be greater than or equal to the modulus of elasticity of the lens material. In some embodiments, the modulus of elasticity of the mask material can be less than the modulus of elasticity of the lens material.


In any of the above mentioned aspects, the mask material can include silicone or acrylic.


In any of the above mentioned aspects, the lens material and the mask material can include the same material.


In any of the above mentioned aspects, the mask can include a plurality of holes characterized in that at least one of a hole size, shape, orientation, and spacing of the plurality of holes is varied to reduce the tendency of the holes to produce visible diffraction patterns.


In any of the above mentioned aspects, the mask can include a thickness of less than or equal to about 200 microns, preferably less than or equal to about 100 microns. For example, the thickness can be at least about 4 microns and less than or equal to about 20 microns, or less than or equal to about 15 microns, or less than or equal to about 10 microns.


In any of the above mentioned aspects, the lens body can include an outer diameter between about 3 mm and about 6 mm. Further, the lens body can be capable of insertion through an incision having a chord length of less than or equal to about 3.0 mm or less than or equal to about 2.4 mm.


In any of the above mentioned aspects, the intraocular lens can be configured such that a room temperature optical power of the intraocular lens can be within about 0.15 diopters, such as within about 0.03 diopters of 0.1 diopters, for example, about 0.13 diopters, of a body temperature optical power of the intraocular lens.


In any of the above mentioned aspects, the intraocular lens can undergo a temperature differential of about 10° C. without substantially affecting optical power.


Certain aspects of this disclosure are directed toward a method of implanting an intraocular lens. The method can include creating an incision having a chord length of less than or equal to about 2.4 mm, and injecting an intraocular lens through the incision using an injector system.


The injected intraocular lens can include a mask embedded within, or secured to, a lens body including a lens material. The mask can include an aperture for improving depth of focus. In some embodiments, the modulus of elasticity of the mask material can be within about 30 percent of the modulus of elasticity of the lens material, or within about 20 percent of the modulus of elasticity of the lens material, or within about 10 percent of the modulus of elasticity of the lens material, or within about 5 percent of the modulus of elasticity of the lens material. In some embodiments, the modulus of elasticity of the mask material can be greater than or equal to the modulus of elasticity of the lens material. In some embodiments, the modulus of elasticity of the mask material can be less than the modulus of elasticity of the lens material. The intraocular lens can further include any of the aspects of the intraocular lenses described above.


Certain aspects of this disclosure are directed toward a method of implanting an intraocular lens. The method can include creating an incision, injecting an intraocular lens through the incision using an injector system, and introducing the intraocular lens to a temperature differential of at least about 10° C. without substantially affecting optical power.


The injected intraocular lens can include a mask embedded within, or secured to, a lens body including a lens material. The mask can include an aperture for improving depth of focus. Further, the mask can include a material having a coefficient of thermal expansion that is within about 30 percent of a coefficient of thermal expansion of the lens material, within about 20 percent of a coefficient of thermal expansion of the lens material, within about 10 percent of a coefficient of thermal expansion of the lens material, or within about 5 percent of a coefficient of thermal expansion of the lens material. The intraocular lens can further include any of the aspects of the intraocular lenses described above.


Certain aspects of this disclosure are directed toward a method of manufacturing an intraocular lens. The method can include forming a mask with an aperture for improving depth of focus from a mask material, inserting a lens material into a mold, and curing the lens material to form a lens body. The lens body can include the mask therein. The lens material can include a modulus of elasticity that is within about 30 percent of a modulus of elasticity of the mask material. The intraocular lens can further include any of the aspects of the intraocular lenses described above.


Certain aspects of this disclosure are directed toward a method of manufacturing an intraocular lens. The method can include forming a mask with an aperture for improving depth of focus from a mask material, inserting a lens material into a mold, and curing the lens material to form a lens body. The lens body can include the mask therein. Further, the lens material can include a coefficient of thermal expansion that is within about 30 percent of a coefficient of thermal expansion of the mask material. The intraocular lens can further include any of the aspects of the intraocular lenses described above.


In any of the above mentioned methods of manufacturing, the method can include forming the mask by spin-casting the mask material, stamping the mask material, printing the mask material, or extruding the mask material.


In any of the above mentioned methods of manufacturing, the method can include, after curing the lens material, chemically extracting residual lens material.


Any feature, structure, or step disclosed herein can be replaced with or combined with any other feature, structure, or step disclosed herein, or omitted. Further, for purposes of summarizing the disclosure, certain aspects, advantages and features of the inventions have been described herein. It is to be understood that not necessarily any or all such advantages are achieved in accordance with any particular embodiment of the inventions disclosed herein. No aspects of this disclosure are essential or indispensable.





BRIEF DESCRIPTION OF THE DRAWINGS

Various embodiments are depicted in the accompanying drawings for illustrative purposes, and should in no way be interpreted as limiting the scope of the embodiments. Furthermore, various features of different disclosed embodiments can be combined to form additional embodiments, which are part of this disclosure.



FIG. 1A illustrates a top view of an example embodiment of an intraocular lens having an embedded mask for improving depth of focus.



FIG. 1B illustrates a cross-sectional view of the intraocular lens of FIG. 1A taken along line 1B-1B.



FIG. 2A is a perspective view of one embodiment of a mask configured to increase depth of focus.



FIG. 2B is a perspective view of an embodiment of a substantially flat mask configured to increase depth of focus.



FIG. 3A is a top view of another embodiment of a mask configured to increase depth of focus.



FIG. 3B is an enlarged view of a portion of the view of FIG. 3A.



FIG. 3C is a cross-sectional view of the mask of FIG. 3B taken along line 3C-3C.



FIG. 4 is a graphical representation of one arrangement of holes of a plurality of holes that may be formed in the mask.





DETAILED DESCRIPTION

As discussed herein, people who undergo intraocular lens (IOL) implantation surgery may still suffer from defects in their non-distance eyesight (e.g., presbyopia). One technique for treating such defects is by including a mask within the IOL that increases the patient's depth of focus. The intraocular implants of the embodiments described herein include a mask adapted to provide a small aperture for light to pass through to the retina to increase depth of focus. The light rays that pass through the mask within the IOL converge at substantially a single focal point on the retina, while the light rays that would not converge at the single point on the retina are blocked by the mask.


Several alternatives to fixed-focus IOLs have been developed for improving non-distance eyesight, including multifocal IOLs and accommodating IOLs. These devices attempt to provide the ability to see clearly at both near and far distances. However, accommodating IOLs can be complex and some multifocal IOLs do not perform well at intermediate distances and cause glare, halos, and night vision difficulties associated with the presence of unfocused light. This limitation can force designers of multifocal optics to choose how much of the light is directed to each focal point, and to deal with the effects of the unfocused light that is always present in any image. In order to maximize acuity at the important distances of infinity (e.g., >6M) and 40 cm (e.g., a normal reading distance), it is typical to provide little or no light focused at an intermediate distance, and as a result, visual acuity at these distances is poor. With a mask that includes an aperture to increase depth-of-focus, however, the intermediate vision of a patient can be improved significantly. For example, the defocus blur associated with the aperture can be less at intermediate distances than at near.



FIGS. 1A-B illustrate an example embodiment of an intraocular lens having an embedded mask 1008 for increasing depth of focus. The intraocular lens 1000 can include haptics 1004 for positioning the lens within the eye. The cross-sectional thickness of the lens body 1002 is generally dependent on the optical power of the intraocular lens 1000 and the material of the lens body 1002. In particular, the central region of the lens body 1002 is generally the thickest section of the intraocular lens 1000 with a central region cross-sectional thickness 1006. Methods for reducing the thickness of the intraocular lens are described in U.S. Pub. No. 2011/0040376, filed Aug. 13, 2010, which is incorporated herein by reference in its entirety. Any of the teachings of this prior publication can also be applied to the devices and methods in the present disclosure.


One method of implanting the IOL 1000 can include inserting the IOL through a small incision in the eye. The IOL 1000 can be inserted into the eye using an injector system. The injector system can include a cartridge tip for housing the IOL 1000. The size of the hole in the cartridge tip through which the IOL 1000 is injected is typically smaller than the size of the IOL. Thus, the IOL 1000 is deformed (e.g., stretched) when passing through the tip during the injection process. The IOL 1000 can be made of a resilient material such that it can revert back to its pre-injection shape after passing through the cartridge tip. When using this method, the size of the incision is generally dependent on the size of the cartridge tip. Typically, smaller surgical incisions are associated with better surgical outcomes.


However, the size of the cartridge tip and incision can be limited by the material properties of the lens body. This problem can be further complicated by the embedded mask 1008 within the IOL 1000. For example, as the IOL 1000 is pushed through the cartridge tip, the extrusion forces can not only stretch or otherwise deform the IOL but also the embedded mask 1008. In addition, the location of the embedded mask 1008 within the IOL 1000 can be displaced (e.g., the embedded mask can become transversely de-centered and/or longitudinally biased to either side of the desired longitudinal depth of the embedded mask within the IOL).


After releasing the IOL 1000 from the cartridge tip, it is desirable that the IOL 1000 and the embedded mask 1008 achieve a target post-injection optical performance specification (e.g., optical power, presbyopia correction, etc.). For example, it may be desirable for the post-injection optical performance to substantially match the pre-injection optical performance. Thus, in some embodiments, the IOL 1000 and the embedded mask 1008 have material properties (e.g., elasticity) that allow them to revert back to their pre-injection shapes, and, in the case of the embedded mask, its pre-injection location within the IOL.


Similar issues are pertinent to the method of manufacturing the IOL 1000 with the embedded mask 1008. IOL manufacturing processes can involve steps where the IOL swells, undergoes temperature differentials, etc. The mask can be deformed if it does not have sufficient elasticity or a compatible coefficient of thermal expansion when compared to the IOL material.


Some methods of manufacturing the IOL 1000 can include chemically extracting impurities from the IOL. For example, the chemical extraction process can be used to remove residual lens material monomer. The chemical extraction process can include immersing the IOL in a chemical (e.g., hexane, benzene, or alcohol) over a pre-determined period of time and a particular temperature profile. In some instances, during the chemical extraction process, the lens body can undergo a volumetric increase of at least about 10%. If the material properties of the mask material differ too much from the material properties of the lens material, then the mask 1008 can undergo deformation and/or displacement, thus degrading the optical performance of the IOL. This can occur if, for example, the modulus of elasticity of the mask material is much different than the modulus of elasticity of the lens material.


It can be particularly difficult to maintain the desired optical performance through deformations and temperature differentials when the mask 1008 and the lens body exhibit incompatible material properties (e.g. modulus of elasticity or coefficient of thermal expansion). If one or both of the mask material and lens body material do not exhibit appropriate material properties, the mask 1008 and/or lens body can be permanently deformed or, in the case of the embedded mask, biased to an undesired location within the IOL, during deformations (such as those that may occur during chemical extractions), and/or temperature shifts. This can affect optical performance (e.g., optical power or presbyopia correction). For example, if the lens body exhibits greater elasticity than the mask material, then, after injection, the mask 1008 can be deformed and degrade the optical performance of the IOL 1000. As another example, if the coefficients of expansion of the lens material and the mask material are too different, when the IOL transitions from room temperature (e.g., about 20° C.) to body temperature (e.g., about 35-37° C.), the resulting stress and strain can cause the mask to be deformed and degrade the optical performance of the IOL.


Provided below are examples of IOLs with embedded masks that are designed to overcome the issues described above. In some implementations, the IOLs (e.g., 1000) with embedded masks (e.g., 1008) that are described herein include substantially the same optical characteristics pre-injection and post-injection.


Masks



FIG. 2A illustrates one embodiment of a mask 2034a. The mask 2034a can include an annular region 2036a surrounding an aperture 2038a substantially centrally located on the mask 2034a. The aperture 2038a can be generally located around a central axis 2039a, referred to herein as the optical axis of the mask 2034a. The aperture 2038a can be in the shape of a circle. FIG. 2B illustrates another embodiment of a mask 2034b similar to the mask 2034a illustrated in FIG. 2A. The annular region 2036a of the mask 2034a of FIG. 2A has a curvature from the outer periphery to the inner periphery of the annular region 2036a, while the annular region 2036b of the mask 2034b of FIG. 2B can be substantially flat (as shown in FIG. 1B). Although the examples provided herein are generally discussed in connection with the mask 2034b, any of the examples can include the mask 2034a. In addition, a variety of variations of masks that can be positioned on or within the implant body are discussed herein, and are also described in U.S. Patent Publication No. 2012/0143325, filed Feb. 10, 2012, which is incorporated by reference herein in its entirety. Any of the teachings of this prior publication can also be applied to the devices and methods in the present disclosure.


The mask 2034b can have dimensions adapted to function with the implant body to improve a patient's vision. For example, the thickness of the mask 2034b can vary depending on the location of the mask 2034b relative to the implant body. For example, if the mask 2034b is embedded within the implant body, the mask 2034b can have a thickness greater than zero and less than the thickness of the implant body. Alternatively, if the mask is coupled to a surface of the implant body, the mask 2034b may have a thickness no greater than necessary to have the desired opacity so that the mask does not add additional thickness to the intraocular lens.


In some implementations, the mask 2034b can have a substantially constant thickness. However, in other implementations, the thickness of the mask may vary between the inner periphery (near the aperture 2038b) and the outer periphery.


In general, the thickness of the mask 2034b can be less than or equal to about 200 microns, or less than or equal to about 100 microns, but preferably between about 1 micron and about 20 microns. For example, the thickness of the mask 2034b can be within the range from about 1 micron to about 40 microns, in the range from about 5 microns to about 20 microns, or otherwise. In some embodiments, the mask 2034b can include a thickness of at least about 5 microns and/or less than or equal to about 20 microns. In some embodiments, the mask 2034b can include a thickness of at least about 5 microns and/or less than or equal to about 15 microns. In certain embodiments, the thickness can be within two microns of about 15 microns, about 10 microns, about 8 microns, about 5 microns, or otherwise. In other embodiments, however, the mask may be a bulk mask and its width may extend across much of the thickness of the lens (e.g., the width of the mask may be at least about 80 percent of the thickness of the implant body or at least about 90 percent of the thickness of the implant body).


The mask 2034b can be symmetrical, e.g., symmetrical about a mask axis 2039b. In some embodiments, the outer periphery of the mask 2034b can be circular. The mask 2034b in general can have an outer diameter of at least about 3 mm and/or less than about 6 mm. In some embodiments, the mask 2034b can be circular and can include a diameter of at least about 3 mm and/or less than or equal to about 4 mm. In some embodiments, the mask 2034b can be circular and can include a diameter within a range of 0.2 mm of about 3.2 mm.


In some embodiments, the aperture 2038b can be substantially circular and can be substantially centered in the mask 2034b. The size of the aperture 2038b can be any size that is effective to increase the depth of focus of an eye of a patient with presbyopia. In particular, the size of the aperture 2038b can be dependent on the location of the mask within the eye (e.g., distance from the retina). In some embodiments, the aperture 2038b can have a diameter of at least about 0.85 mm and/or less than or equal to about 2.2 mm. In certain embodiments, the diameter of the aperture 2038b is less than or equal to about 2 mm. In some embodiments, the diameter of the aperture 2038b is at least about 1.1 mm and/or less than or equal to about 1.6 mm. In some embodiments, the diameter of the aperture 2038b is at least about 1.3 mm and/or less than or equal to about 1.4 mm.


The aperture 2038b can transmit substantially all incident light along the mask axis 2039b. The annular region 2036b can substantially prevent transmission of incident light thereon. The aperture 2038b can be a through-hole in the annular region 2036b or a substantially light transmissive (e.g., transparent) portion thereof. The aperture 2038b of the mask 2034b can be generally defined within the outer periphery of the mask 2034b.


The annular region 2036b can at least partially prevent transmission of visible light through the mask 2034b. For example, in some embodiments, the annular region 2036b can prevent transmission of substantially all or at least a portion of the spectrum of the incident visible light. In some embodiments, the annular region 2036b can prevent transmission of substantially all visible light, e.g., radiant energy in the electromagnetic spectrum that is visible to the human eye. The annular region 2036b can substantially prevent transmission of radiant energy outside the range visible to humans in some embodiments.


Preventing transmission of light through the annular region 2036b can decrease the amount of light that reaches the retina and the fovea that would not converge at the retina and fovea to form a sharp image. As discussed above, the size of the aperture 2038b is such that the light transmitted therethrough generally converges at the retina or fovea. Accordingly, a much sharper image can be presented to the retina than would otherwise be the case without the mask 2034b.


In some embodiments, the annular region 2036b can prevent transmission of at least about 90 percent of incident light. In some embodiments, the annular region 2036b can prevent transmission of at least about 92 percent, at least about 95 percent, or at least about 98 percent of all incident light. The annular region 2036b of the mask 2034b can be substantially opaque to prevent the transmission of light.


In some embodiments, the annular region 2036b can transmit no more than about 5% of incident visible light. In some embodiments, the annular region 2036b can transmit no more than about 3 percent of incident visible light. In some embodiments, the annular region 2036b can transmit no more than about 2 percent of incident visible light. In some embodiments, at least a portion of the annular region 2036b can be opaque to more than 99 percent of the light incident thereon.


As discussed above, the annular region 2036b can prevent at least partial transmission of light without absorbing the incident light. For example, the mask 2034b can be reflective or can interact with the light in a more complex manner, as discussed in U.S. Pat. No. 6,554,424, issued Apr. 29, 2003, which is hereby incorporated by reference in its entirety.


The annular region 2036b can be at least partially opaque or can be completely opaque. The degree of opacity of the annular region 2036b can prevent at least some or substantially all light from being transmitted through the mask 2034b. Opacity of the annular region 2036b can be achieved in any of several different ways. For example, the material used to make mask 2034b can be naturally opaque. As another example, the material used to make the mask 2034b can be substantially clear, but treated with a dye or other pigmentation agent to render region 2036b substantially or completely opaque. In certain embodiments, the mask can include carbon black. In yet another example, the surface of the mask 2034b can be treated physically or chemically (such as by etching) to alter the refractive and transmissive properties of the mask 2034b and make it less transmissive to light.


In some embodiments, a photochromic material can be used as the mask or in addition to mask. Under bright light conditions, the photochromic material can darken thereby creating a mask and enhancing near vision. Under dim light conditions, the photochromic material can lighten, which allows more light to pass through to the retina. In certain embodiments, under dim light conditions, the photochromic material lightens to expose an optic of the intraocular implant. Further photochromic material details are disclosed in U.S. Patent Publication No. 2013/0268071, filed Nov. 30, 2012, which is hereby incorporated by reference in its entirety.


The mask can transition between different degrees of opacity. For example, at least a portion of the mask can transition between at least a first degree of opacity and a second degree of opacity. Further details are disclosed in U.S. application Ser. No. 13/830,889, filed Mar. 14, 2013, which is hereby incorporated by reference in its entirety.


In some embodiments, the opacity of the mask can also vary in different regions of the mask. For example, the opacity of the outer edge and/or the inner edge of the mask can be less than the central region of the mask. The opacity in different regions can transition abruptly or have a gradient transition. Additional examples of opacity transitions can be found in U.S. Pat. Nos. 5,662,706, 5,905,561 and 5,965,330, all of which are hereby incorporated by reference in their entirety.



FIGS. 3A-3C show another embodiment of a mask 2100 capable of increasing depth of focus of an eye of a patient with presbyopia. The mask 2100 can be flat (as in FIG. 2B) or curved (as in FIG. 2A). The mask 2100 can be similar to the masks hereinbefore described, except as described differently below. The mask 2100 can be made of the materials discussed herein, including those discussed above. In addition, the mask 2100 can be formed by any suitable process. The mask 2100 can be applied to and/or embedded in an IOL.


The mask 2100 can include a plurality of holes 2120. When the mask 2100 is embedded in the lens body, the lens body can extend at least partially through the holes, thereby creating a bond (e.g. material “bridge”) between the lens body on either side of the mask. Further disclosure regarding the material “bridge” can be found in U.S. Publication No. 2011/0040376, filed Aug. 13, 2010, which is incorporated by reference herein in its entirety.


The holes 2120 of the mask 2100 shown in FIG. 3A can be located anywhere on the mask 2100. In some embodiments, substantially all of the holes are in one or more regions of a mask. The holes 2120 of FIG. 3A extend at least partially between the anterior surface 2108 and the posterior surface 2112 of the mask 2100. In some embodiments, each of the holes 2120 includes a hole entrance 2160 and a hole exit 2164. The hole entrance 2160 is located adjacent to the anterior surface 2108 of the mask 2100. The hole exit 2164 is located adjacent to the posterior surface 2112 of the mask 2100. In some embodiments, each of the holes 2120 extends the entire distance between the anterior surface 2108 and the posterior surface 2112 of the mask 2100. Further details about possible hole patterns are described in U.S. Patent Publication No. 2012/0143325, filed Feb. 10, 2012, which is incorporated by reference herein in its entirety.



FIG. 4 illustrates a graphical representation of the hole pattern of the mask 2100. In some embodiments, the mask 2100 can include an annular region near the outer periphery 2124 of the mask having no holes. In certain embodiments, there are no holes within 0.1 mm of the outer periphery 2124 of the mask 2100.


The holes in the mask serve at least two purposes: the holes provide some light transmission and, as just discussed with respect to FIGS. 3A-3C, the holes create areas where the material of the implant body can extend through to create a material “bridge” that holds the mask in place. Advantageously, if the mask is in a position between the posterior and anterior surfaces of a lens body, the holes through the mask can help to prevent delamination of the interface between the mask and the lens body. Delamination can occur during manipulation of the intraocular implant such as when the intraocular implant is folded or rolled and placed into a tube to be implanted into the patient. The lens body can extend through the holes, thereby creating a bond (e.g. material “bridge”) between the lens body on either side of the mask. Delamination can also be reduced by matching mechanical properties (e.g. elastic modulus) of the mask to the lens body. Another method to reduce delamination is to create a bond between the lens body and the mask. For example, the lens body and the mask can have cross-linking bonds or van der Waals forces between them.


It can be desirable to decrease or minimize the total amount of light that passes through the mask in order to increase or maximize near image contrast. Delamination can be prevented with a relatively small total area of the mask having holes for “bridges”. For example, an area of about 3% of the mask can include holes which can balance increasing or maximizing mechanical strength and reducing or minimizing optical effects of the holes. In certain embodiments, the anterior surface of the mask has a mask surface area, and the light transmission structures (e.g., holes) in the mask have a total area on the anterior surface of the mask of about 1% to about 5% of the mask surface area. To limit the impact of diffraction of light passing through the holes of the mask, the holes can be made as small as possible. The Airy disc from each hole is larger the smaller the hole size, so the composite diffraction pattern produced by the pattern of holes becomes larger as well. The composite diffraction pattern spreads light over a larger portion of the retina, decreasing the local brightness of diffracted light and making diffraction artifacts less visible. Diffraction patterns produced by a pattern of holes also tends to have a chromatic component such that the diffraction halo tends to graduate in color radially. Varying the size of the holes produces this effect in multiple scales, which scrambles the color of the halo. This reduces color contrast in the halo, making it less noticeable.


The outer diameter of the outer periphery of the mask can be varied. In certain embodiments, the outer diameter is selected to selectively allow an amount of light to pass to the retina of the eye. The pupil of the eye changes size in different lighting condition. In low light situations, the pupil of the eye enlarges to let more light into the eye. The outer diameter can be selected so that light does not pass outside the outer periphery of the mask in relatively high light conditions, and so that at least some light can pass outside the outer periphery of the mask in relatively low light conditions. The pupil size of patients often can vary; therefore, the outer diameter of the mask can be selected for a specific patient pupil size. For example, for patients with relatively small pupils, dim light may present more of a vision issue than for patients with larger pupils. For smaller-pupil patients, a mask with more light transmission and/or a smaller outer diameter will increase light reaching the retina and improve vision in dim light situations. Conversely, for larger pupil patients, less light transmission and/or a larger outer diameter mask may improve low-contrast near vision and block more unfocused light. The masked IOLs of the present application give the surgeon flexibility to prescribe the appropriate combination of masked IOL features for particular patients.


In certain embodiments, the center of the aperture of the mask is off-center to the center of the lens body. By having an aperture off-center to the optical center of the lens body, the intraocular lens can be rotated during the implantation procedure so that the optical center of the patient's eye can be aligned with the center of the aperture. The vision of the patient can be improved by aligning the optical center of the patient's eye with the aperture center.


In some embodiments, the mask 2100 can include an annular region near the outer periphery 2124 of the mask having no holes. In certain embodiments, there are no holes within 0.1 mm of the outer periphery 2124 of the mask 2100.


In some embodiments, the mask can include an annular region around the inner periphery of the mask having no holes. In certain embodiments, there are no holes within 0.1 mm of the aperture 2128.


In some embodiments, the holes 2120 each have the same diameter. In certain embodiments, the holes 2120 can include one or more different diameters. In some embodiments, the diameter of any single hole 2120 is at least about 0.01 mm and/or less than or equal to about 0.02 mm. In some embodiments, the diameter of the holes 2120 can vary within 0.001 mm of one or more of the following hole diameters: 0.010 mm, 0.013 mm, 0.016 mm, and/or 0.019 mm. In some embodiments, holes of different diameters are interspersed throughout at least a portion of the mask 2100. In some embodiments, the holes are interspersed at irregular locations throughout at least a portion of the mask 2100.


In certain embodiments, the mask includes holes greater than about 7 microns in diameter (e.g., greater than a cross-sectional area of about 35 μm2), and preferably greater than about 10 microns in diameter (e.g., greater than a cross-sectional area of about 75 μm2). In certain embodiments, the mask includes holes greater than about 7 microns in diameter (e.g., greater than a cross-sectional area of about 35 μm2) and less than about 20 microns in diameter (e.g., less than a cross-sectional area of about 320 μm2). In further embodiments, the mask includes holes less than about 50 microns in diameter (e.g., less than a cross-sectional area of about 2000 μm2. Holes with diameters less than 7 microns may not be large enough for lens material such as silicone or acrylic to enter and migrate to form a bridge. However, the viscosity of the lens material will determine whether the material will be able to migrate into the hole to form the bridge and a minimum cross-sectional area of the hole may be dependent on the material of the implant body. If the material of the implant body does not migrate into a hole, that hole may create a bubble that could interfere with the visual performance of the implant.


In a certain embodiment, the mask includes randomly or pseudo-randomly placed holes across the mask. The mask can include holes with one of four hole diameters within the parameters provided above. There can be an equal number of holes with each hole diameter. An algorithm can be used to randomly or pseudo-randomly assign the variously sized holes to locations across the mask annulus. The rules for the randomization program can include (1) that there be no “collisions” of the holes (e.g., the holes have no contact with each other), (2) that no holes interfere with the inner and outer peripheral edges of the mask, and (3) that the holes are placed in such a way as to create substantial uniform density across the mask annulus. For example, the rules for the randomization program may include one or more of these rules.


In some embodiments there are at least about 1000 holes and/or less than or equal to about 2000 holes. In some embodiments, there are at least about 1000 holes and/or less than or equal to about 1100 holes. In some embodiments, the number of holes is within ten holes of about 1040 holes. In some embodiments, there are an equal number of holes of each diameter. In some embodiments, the number of holes having each diameter is different.


In some embodiments, the holes are interspersed at irregular locations throughout at least a portion of the mask 2100. In some embodiments, holes of different diameters are evenly interspersed throughout at least a portion of the mask 2100. For example, the mask 2100 can include a plurality of non-overlapping hole regions. The sum of the surface area of the plurality of non-overlapping hole regions can equal the total surface area of the entire hole region of the mask. In some implementations, each region of the plurality of regions can include a number of holes, each of the holes having a different diameter. In some implementations, the number of holes in each region can equal the number of different hole sizes in the entire hole region. In some implementations, an amount of open area within each hole region can be substantially the same. In some implementations, each hole region can include the same number of holes.


Any of the masks discussed herein can be formed of any suitable material, including, but not limited to, at least one of an open cell foam material, an expanded solid material, and/or a substantially opaque material. In some embodiments, the material used to form the mask can have relatively high water content. In some embodiments, the materials that can be used to form the body 2104 include polymers (e.g. PMMA, PVDF, polypropylene, polycarbonate, PEEK, polyethylene, polystyrene, PVC, polysulfone), hydrogels, metals, metal alloys, or carbon (e.g., graphene, pure carbon), but preferably acrylic copolymers or silicone.


In some embodiments, the durometer (type A) of the mask material can be less than or equal to about 100, for example, between about 25 and about 50, such as about 40. In some embodiments, the percent elongation to break for the mask material can be between about 150 percent and about 600 percent, for example, within about 50 percent of each of about 200 percent, 250 percent, 300 percent, 350 percent, 400 percent, 450 percent, 500 percent, or about 550 percent. In some instances, the elongation can be between about 150 percent and about 200 percent, such as about 175 percent. In some instances, the elongation can be between about 500 percent and about 600 percent, such as about 550 percent. In some embodiments, the tensile strength of the mask material can be less than or equal to 15 MPa, for example, within about 2 MPa of each of about 10 MPa, 8 MPa, 6 MPa, or 4 MPa. In some embodiments, the modulus of elasticity of the mask material can be between about 0.5 MPa and about 2 MPa, for example, within about 0.25 MPa of about 0.75 MPa, 1.0 MPa, 1.25 MPa, 1.5 MPa, or 1.75 MPa.


As described above, methods of manufacturing the IOL and methods of implanting the IOL can degrade optical performance of the IOL if the material properties of the IOL and the mask are not compatibly selected to withstand, for example, deformations (such as those resulting from swelling that may occur during chemical extractions or treatments), and temperature shifts. As such, it can be desirable to select a mask material and a lens material having appropriate material properties to allow the device to revert to, or otherwise achieve, a desired optical performance even after suffering some type of deformation or temperature differential.


In some implementations, the modulus of elasticity of the mask material can be within about 50 percent of the modulus of elasticity of the lens material. In some implementations, the modulus of elasticity of the mask material can be within about 45 percent of the modulus of elasticity of the lens material, or within about 30 percent of the modulus of elasticity of the lens material, or within about 20 percent of the modulus of elasticity of the lens material, or within about 10 percent of the modulus of elasticity of the lens material, or within about 5 percent of the modulus of elasticity of the lens material. In some implementations, the modulus of elasticity of the mask material can be greater than or equal to the modulus of elasticity of the lens material; while, in other implementations, the modulus of elasticity of the mask material can be less than the modulus of elasticity of the lens material. In some implementations, the modulus of elasticity of the mask material can be substantially the same as the modulus of elasticity of the lens material.


Since the lens material is more voluminous than the mask material, the properties of the lens material will generally dominate. Thus, it can be particularly advantageous if the elasticity of the mask material is at least as great as that of the lens material in order to allow the embedded mask to react to deformation of the lens without becoming damaged or displaced.


In some implementations, the mask material can be the same as the lens material. In some implementations, the mask material can include a hydrophilic or hydrophobic material. In some implementations, the mask material can include an acrylic copolymer or silicone.


In some embodiments, the lens material can include a hydrophilic or hydrophobic material. In some implementations, the lens material can include an acrylic copolymer or silicone. The modulus of elasticity of the lens material can be between about 0.50 MPa and about 1.5 MPa, for example, between about 0.75 MPa and about 1.25 MPa, such as within about 0.1 MPa of each of about 1.0 MPa, 1.1 MPa, 1.2 MPa, or 1.3 MPa. The percentage of elongation to break can be between about 150 percent and about 200 percent, for example, between about 160 percent and about 190 percent or between about 170 percent and about 180 percent, such as about 175 percent.


In some implementations, the coefficient of thermal expansion of the mask material is substantially similar to that of the lens material. In this way, the mask material and the lens material respond to temperature differentials in similar ways to avoid the development of stress or strain between the mask and the IOL. In some implementations, the coefficient of thermal expansion of the mask material can be within about 30 percent of the coefficient of thermal expansion of the lens material, or within about 20 percent of the coefficient of thermal expansion of the lens material, or within about 10 percent of the coefficient of thermal expansion of the lens material, or within about 5 percent of the coefficient of thermal expansion of the lens material. In some implementations, the coefficient of thermal expansion of the mask material can be substantially the same as the coefficient of thermal expansion of the lens material.


In some implementations, the mask material can be the same as the lens material. In some implementations, the mask material can include a hydrophilic or hydrophobic material. In some implementations, the mask material can include an acrylic copolymer or silicone.


In some implementations, the lens material can include a hydrophilic or hydrophobic material. In some implementations, the mask material can include an acrylic copolymer or silicone.


Methods of Use


Any of the IOLs described herein can be implanted using an injection system. The method can include injecting the IOL through a small cartridge tip having an inside diameter of less than or equal to about 2.0 mm, for example, within about 0.2 mm of about 1.5 mm, preferably less than or equal to about 1.5 mm, such as between about 1.5 mm and about 1.25 mm or between about 1.25 mm and about 1.0 mm. The injection system can deliver the IOL through an incision having a chord length of less than or equal to about 2.4 mm. The IOL can be configured to transition between a pre-injection configuration (e.g., rolled up for implantation) and a post-injection configuration (expanded, in-situ shape). The pre-injection configuration can be substantially smaller than the post-injection configuration.


In some implementations, it can be desirable for the IOL to transition between the pre-injection configuration and the post-configuration without substantially changing optical performance. For example, the optical power of the IOL prior to injection can be within about 0.5 diopters, preferably within about 0.3 diopters, or within about 0.2 diopters, or within about 0.1 diopters, of the optical power of the IOL after injection.


As mentioned above, the IOL can expand when it is introduced into the body because of the difference between room and body temperature in the eye, e.g., in an anterior chamber of the eye. In some implementations, the temperature differential can be between about 5° C. and about 20° C., for example, between about 5° C. and about 10° C., between about 10° C. and 15° C., or between about 15° C. and about 20° C. The room temperature can be between about 18° C. and about 26° C., and the temperature of the anterior chamber of the eye can be between about 18° C. (e.g., transiently during irrigation/aspiration) and about 37° C.


In some implementations, it can be desirable for the IOL to undergo the temperature differential without substantially changing optical performance. For example, the optical power of the IOL at room temperature can be within about 0.15 diopters, such as within about 0.03 diopters of about 0.1 diopters, for example, about 0.13 diopters, of the optical power of the IOL at body temperature.


Methods of Manufacturing


Various techniques can be used for forming the mask. In some embodiments, the mask can be formed using a mask material alone or in combination with an opacification agent. The mask material can include any of the mask materials described herein, for example, silicone or an acrylic copolymer. In some implementations, the mask material can be combined with an opacification agent, such as carbon black, or any class 3 medical device material.


In some embodiments, the resulting mixture can be used to form a mask film having a thickness equal to the desired mask thickness. Techniques for forming the mask film can include allowing mask material to spread to a desired thickness by gravity or by spinning. Each mask can then be formed from the mask film using a stamp, sieve, die, laser, or other machine. In an alternative technique, the mask material can be formed into a tube (e.g., using an extrusion process), and masks having the desired thickness can be cut from the tube. Further mask materials and methods of making a mask are disclosed in U.S. Pub. No. 2011/0040376, filed Aug. 13, 2010, which is incorporated by reference herein in its entirety.


After forming the mask, the mask can be embedded within or applied to a lens body. For example, the method can include pre-dosing a first lens forming mold portion with a first amount of lens material and positioning the mask on a positioning mold portion. Thereafter, the first lens forming mold portion and the positioning mold portion can be joined together, and the lens material can be at least partially cured. After partially curing the lens material, at least the first lens forming mold portion can be cooled to facilitate the separation of the mold portions without disrupting the position of the mask. Once the mold portions are separated, a second amount of lens material can be added to the first lens forming mold portion and/or a second lens forming mold portion, and the first lens forming mold portion and the second lens forming mold portion can be joined together. In this configuration, the first and the second amounts of lens material can be at least partially cured, for example, using a light cure. Finally, the final curing process can be carried out using thermal curing. In some implementations, depending on the mask and lens materials, the IOL can undergo chemical extraction to remove any impurities. Further details regarding this manufacturing method or alternatives can be found in U.S. patent application Ser. No. 13/830,889 and U.S. Publication No. 2014/0131905, both filed Mar. 14, 2013, which are incorporated by reference herein in their entireties.


Alternatively, the intraocular lens can be manufactured using stereolithography to image the mask within the lens. The method can include providing a first amount of photoreactive lens material. Next, the method can also include forming a first layer of the intraocular lens by curing the first amount of photoreactive lens material to form the desired shape. Thereafter, the method can include providing a second amount of photoreactive lens material over the cured first layer and forming a second layer of the intraocular lens by curing the second amount of photoreactive lens material to form the desired shape. This process can be repeated to additively form the lens. After one or more initial layers of the lens have been formed, a mask can be imaged within the initial layers by activating dyes such as those described in U.S. Publication No. 2013/0268071, filed Nov. 30, 2012, and U.S. Pat. No. 8,604,098, filed Jul. 6, 2011, which are incorporated by reference herein in their entireties, by laser ablation, or by other methods to create opacity, as described in U.S. Publication 2013/0289543, filed Mar. 12, 2013, which is also by incorporated by reference herein in its entirety. Once the mask is in place, the process of providing and curing layers of photoreactive lens material can be continued such that the mask is embedded within the completed lens. The lens can be formed such that the mask can be imaged within the lens in a manner that provides the mask with the same physical properties as the lens, thus allowing the mask to flex with the lens without damage.


As explained above, the manufacturing method can include an extraction process to remove impurities. For example, the method can include a chemical extraction process. During the chemical extraction process, the IOL can undergo a volumetric increase of at least about 5%, sometimes at least about 10%.


In some implementations, it can be desirable to subject the IOL to the chemical extraction process without substantially changing optical performance. For example, the optical power of the IOL before extraction can be within about 0.5 diopters, preferably within about 0.3 diopters, or within about 0.2 diopters, or within about 0.1 diopters, of the optical power of the IOL after extraction.


Conditional language, such as “can,” “could,” “might,” or “may,” unless specifically stated otherwise, or otherwise understood within the context as used, is generally intended to convey that certain embodiments include, while other embodiments do not include, certain features, elements, and/or steps. Thus, such conditional language is not generally intended to imply that features, elements, and/or steps are in any way required for one or more embodiments or that one or more embodiments necessarily include logic for deciding, with or without user input or prompting, whether these features, elements, and/or steps are included or are to be performed in any particular embodiment.


The terms “approximately,” “about,” and “substantially” as used herein represent an amount close to the stated amount that still performs a desired function or achieves a desired result. For example, the terms “approximately”, “about”, and “substantially” may refer to an amount that is within less than 10% of, within less than 5% of, within less than 1% of, within less than 0.1% of, and within less than 0.01% of the stated amount.


Although certain embodiments and examples have been described herein, it will be understood by those skilled in the art that many aspects of the methods and IOLs shown and described in the present disclosure may be differently combined and/or modified to form still further embodiments or acceptable examples. All such modifications and variations are intended to be included herein within the scope of this disclosure. A wide variety of designs and approaches are possible. No feature, structure, or step disclosed herein is essential or indispensable.


Some embodiments have been described in connection with the accompanying drawings. However, it should be understood that the figures are not drawn to scale. Distances, angles, etc. are merely illustrative and do not necessarily bear an exact relationship to actual dimensions and layout of the devices illustrated. Components can be added, removed, and/or rearranged. Further, the disclosure herein of any particular feature, aspect, method, property, characteristic, quality, attribute, element, or the like in connection with various embodiments can be used in all other embodiments set forth herein. Additionally, it will be recognized that any methods described herein may be practiced using any device suitable for performing the recited steps.


For purposes of this disclosure, certain aspects, advantages, and novel features are described herein. It is to be understood that not necessarily all such advantages may be achieved in accordance with any particular embodiment. Thus, for example, those skilled in the art will recognize that the disclosure may be embodied or carried out in a manner that achieves one advantage or a group of advantages as taught herein without necessarily achieving other advantages as may be taught or suggested herein.


Moreover, while illustrative embodiments have been described herein, the scope of any and all embodiments having equivalent elements, modifications, omissions, combinations (e.g., of aspects across various embodiments), adaptations and/or alterations as would be appreciated by those in the art based on the present disclosure. The limitations in the claims are to be interpreted broadly based on the language employed in the claims and not limited to the examples described in the present specification or during the prosecution of the application, which examples are to be construed as non-exclusive. Further, the actions of the disclosed processes and methods may be modified in any manner, including by reordering actions and/or inserting additional actions and/or deleting actions. It is intended, therefore, that the specification and examples be considered as illustrative only, with a true scope and spirit being indicated by the claims and their full scope of equivalents.

Claims
  • 1. An intraocular lens comprising: a lens body comprising a lens material, the lens body being flexible enough to be injected through an injector system and to revert back to its pre-injection shape, the injector system comprising an injector tip with an inner diameter less than or equal to about 2.0 mm; anda mask with an aperture for improving depth of focus, the mask being opaque and flexible enough to be injected through the injector system and to revert back to its pre-injection shape, the mask comprising an opacification agent and a mask material, the mask material being different from the lens material,wherein a pre-injection optical power of the intraocular lens is within about 0.5 diopters of a post-injection optical power of the intraocular lens.
  • 2. The intraocular lens of claim 1, wherein the pre-injection optical power of the intraocular lens is within about 0.3 diopters of the post-injection optical power of the intraocular lens.
  • 3. The intraocular lens of claim 1, wherein the mask material has a modulus of elasticity that is within about 30 percent of a modulus of elasticity of the lens material.
  • 4. The intraocular lens of claim 1, wherein the modulus of elasticity of the mask material is greater than or equal to the modulus of elasticity of the lens material.
  • 5. The intraocular lens of claim 1, wherein the modulus of elasticity of the mask material is less than the modulus of elasticity of the lens material.
  • 6. The intraocular lens of claim 1, wherein the mask material comprises silicone.
  • 7. The intraocular lens of claim 1, wherein the mask material comprises acrylic.
  • 8. The intraocular lens of claim 1, wherein the mask comprises a thickness of less than or equal to about 200 microns.
  • 9. The intraocular lens of claim 1, wherein the lens body has an outer diameter between about 3 mm and about 6 mm, and wherein the lens body is capable of insertion through an incision having a chord length of less than or equal to about 3.0 mm.
  • 10. The intraocular lens of claim 1, wherein the mask is embedded entirely between a posterior surface and an anterior surface of the lens body.
  • 11. A method of implanting an intraocular lens in an eye, the method comprising: forming an incision in the eye;injecting the intraocular lens through the incision using an injector system comprising an injector tip with an inner diameter less than or equal to about 2.0 mm, the intraocular lens comprising: a lens body comprising a lens material, the lens body being flexible enough to be injected through the injector system and to revert back to its pre-injection shape; anda mask with an aperture for improving depth of focus, the mask being opaque and flexible enough to be injected through the injector system and to revert back to its pre-injection shape, the mask comprising an opacification agent and a mask material, the mask material being different from the lens material,wherein a pre-injection optical power of the intraocular lens is within about 0.5 diopters of a post-injection optical power of the intraocular lens.
  • 12. The method of claim 11, wherein the incision has a chord less of less than or equal to about 2.4 mm.
  • 13. The method of claim 11, wherein the pre-injection optical power of the intraocular lens is within about 0.3 diopters of the post-injection optical power of the intraocular lens.
  • 14. The method of claim 11, wherein the mask material has a modulus of elasticity that is within about 30 percent of a modulus of elasticity of the lens material.
  • 15. The method of claim 11, wherein injecting the intraocular lens through the incision comprises introducing the intraocular lens to a temperature differential of at least about 10° C.
  • 16. The method of claim 11, wherein when the intraocular lens is within the injector system, the intraocular lens is rolled up.
INCORPORATION BY REFERENCE TO ANY PRIORITY APPLICATIONS

This application is a continuation of U.S. application Ser. No. 14/454,585, now U.S. Pat. No. 10,004,593, filed Aug. 7, 2014, which is a continuation-in-part of U.S. application Ser. No. 12/856,492, now U.S. Pat. No. 9,492,272, filed Aug. 13, 2010, titled “MASKED INTRAOCULAR IMPLANTS AND LENSES,” which claims priority benefit under 35 U.S.C. § 119(e) of U.S. Provisional Application No. 61/233,804, filed Aug. 13, 2009, titled “MASKED INTRAOCULAR IMPLANTS AND LENSES,” and U.S. Provisional Application No. 61/233,794, filed Aug. 13, 2009, titled “INTRAOCULAR IMPLANT WITH PRESBYOPIC CORRECTION,” each of which is hereby incorporated by reference in its entirety. This application also claims priority benefit under 35 U.S.C. § 119(e) of U.S. Provisional Application No. 61/863,833, filed Aug. 8, 2013, titled “INTRAOCULAR LENS WITH ELASTIC MASK,” which is hereby incorporated by reference in its entirety.

US Referenced Citations (390)
Number Name Date Kind
2350421 Schoder et al. Jun 1944 A
2470927 Hale, Jr. May 1949 A
3034403 Neefe May 1962 A
3270099 Camp Aug 1966 A
3458870 Stone Aug 1969 A
3578850 Grant May 1971 A
3776230 Neefe Dec 1973 A
3794414 Wesley Feb 1974 A
3877502 Hunckler Apr 1975 A
3996627 Deeg et al. Dec 1976 A
4010496 Neefe Mar 1977 A
4104338 Guerrieri Aug 1978 A
4116439 Chavarria et al. Sep 1978 A
4210391 Cohen Jul 1980 A
4298996 Barnet Nov 1981 A
4340283 Cohen Jul 1982 A
4402579 Poler Sep 1983 A
4423728 Lieberman Jan 1984 A
4435050 Poler Mar 1984 A
4450593 Poler May 1984 A
4505855 Bruns et al. Mar 1985 A
4563565 Kampfer et al. Jan 1986 A
4575373 Johnson Mar 1986 A
4596578 Kelman Jun 1986 A
4607617 Choyce Aug 1986 A
4624669 Grendahl Nov 1986 A
4639105 Neefe Jan 1987 A
4646720 Peyman et al. Mar 1987 A
4655774 Choyce Apr 1987 A
4665913 Esperance, Jr. May 1987 A
4669466 L'Esperance Jun 1987 A
4669834 Richter Jun 1987 A
4676790 Kern Jun 1987 A
4676791 LeMaster et al. Jun 1987 A
4678422 York Jul 1987 A
4701038 Neefe Oct 1987 A
4715858 Lindstrom Dec 1987 A
4767647 Bree Aug 1988 A
4795462 Grendahl Jan 1989 A
4798608 Grendahl Jan 1989 A
4799784 Safir Jan 1989 A
4799931 Lindstrom Jan 1989 A
4807623 Lieberman Feb 1989 A
4813955 Achatz et al. Mar 1989 A
4815690 Shepherd Mar 1989 A
4817789 Paul Apr 1989 A
4830855 Stewart May 1989 A
4842599 Bronstein Jun 1989 A
4842782 Portney Jun 1989 A
4851003 Lindstrom Jul 1989 A
4863466 Schlegel Sep 1989 A
4881860 Kanazawa Nov 1989 A
4903695 Warner et al. Feb 1990 A
4907586 Bille et al. Mar 1990 A
4928815 Paul May 1990 A
4955904 Atebara et al. Sep 1990 A
4976732 Vorosmarthy Dec 1990 A
4994080 Shepard Feb 1991 A
5013319 Davis May 1991 A
5030230 White Jul 1991 A
5034166 Rawlings et al. Jul 1991 A
5041133 Sayano et al. Aug 1991 A
5055602 Melpolder Oct 1991 A
5087015 Galley Feb 1992 A
5090955 Simon Feb 1992 A
5094521 Jolson et al. Mar 1992 A
5098443 Parel et al. Mar 1992 A
5108427 Majercik et al. Apr 1992 A
5112328 Taboada et al. May 1992 A
5120120 Cohen Jun 1992 A
5120121 Rawlings et al. Jun 1992 A
5137441 Fogarty Aug 1992 A
5147395 Willis Sep 1992 A
5171318 Gibson et al. Dec 1992 A
5185107 Blake Feb 1993 A
5188494 Hatin Feb 1993 A
5192316 Ting Mar 1993 A
5196026 Barrett et al. Mar 1993 A
5213749 Huss et al. May 1993 A
5260727 Oksman et al. Nov 1993 A
5266241 Parekh Nov 1993 A
5269795 Arnott Dec 1993 A
5269812 White Dec 1993 A
5274404 Michael Dec 1993 A
5288436 Liu et al. Feb 1994 A
5290892 Namdaran et al. Mar 1994 A
5292514 Capecchi et al. Mar 1994 A
5300116 Chirila et al. Apr 1994 A
5312330 Klopotek May 1994 A
5314439 Sugita May 1994 A
5314961 Anton et al. May 1994 A
5332802 Kelman et al. Jul 1994 A
5336261 Barrett et al. Aug 1994 A
5354331 Schachar et al. Oct 1994 A
5358520 Patel Oct 1994 A
5372580 Simon et al. Dec 1994 A
5391201 Barrett et al. Feb 1995 A
5441511 Hanna Aug 1995 A
5474548 Knopp et al. Dec 1995 A
5507740 O'Donnell, Jr. Apr 1996 A
5547468 Simon et al. Apr 1996 A
D375245 Irving Nov 1996 S
5578080 McDonald Nov 1996 A
5603774 LeBoeuf et al. Feb 1997 A
5607437 Simon et al. Mar 1997 A
5624456 Hellenkamp Apr 1997 A
5627613 Kaneko May 1997 A
5628794 Lindstrom May 1997 A
5628795 Langerman May 1997 A
5647865 Swinger Jul 1997 A
5653752 Silvestrini et al. Aug 1997 A
5662706 Legerton et al. Sep 1997 A
5674284 Chang et al. Oct 1997 A
5693268 Widman et al. Dec 1997 A
5697923 Poler Dec 1997 A
5702440 Portney Dec 1997 A
5708049 Katagiri et al. Jan 1998 A
5713957 Steele et al. Feb 1998 A
5722971 Peyman Mar 1998 A
5725575 O'Donnell, Jr. Mar 1998 A
5746558 Nygren et al. May 1998 A
5752967 Kritzinger et al. May 1998 A
5757458 Miller et al. May 1998 A
5769889 Kelman Jun 1998 A
5774202 Abraham et al. Jun 1998 A
5786883 Miller et al. Jul 1998 A
5824086 Silvestrini Oct 1998 A
5837156 Cumming Nov 1998 A
5843105 Mathis et al. Dec 1998 A
5864128 Plesko Jan 1999 A
5870167 Knopp et al. Feb 1999 A
5895610 Chang et al. Apr 1999 A
5905561 Lee et al. May 1999 A
5910537 Feingold et al. Jun 1999 A
5913898 Feingold et al. Jun 1999 A
5919185 Peyman Jul 1999 A
5925294 Shibuya Jul 1999 A
5964748 Peyman Oct 1999 A
5964776 Peyman Oct 1999 A
5965330 Evans et al. Oct 1999 A
5980040 Xu et al. Nov 1999 A
6017121 Chateau et al. Jan 2000 A
6063073 Peyman May 2000 A
6090141 Lindstrom Jul 2000 A
6102946 Nigam Aug 2000 A
6106553 Feingold et al. Aug 2000 A
6110166 Juhasz et al. Aug 2000 A
6138307 McDonald Oct 2000 A
6152959 Portney Nov 2000 A
6164777 Li et al. Dec 2000 A
6171336 Sawusch Jan 2001 B1
6178593 Carlson Jan 2001 B1
6197019 Peyman Mar 2001 B1
6201036 Fedorov et al. Mar 2001 B1
6203538 Peyman Mar 2001 B1
6210401 Lai Apr 2001 B1
6217571 Peyman Apr 2001 B1
6217596 Farah Apr 2001 B1
6221067 Peyman Apr 2001 B1
6228113 Kaufman May 2001 B1
6228114 Lee May 2001 B1
6228115 Hoffmann et al. May 2001 B1
6264648 Peyman Jul 2001 B1
6277146 Peyman et al. Aug 2001 B1
6280470 Peyman Aug 2001 B1
6280471 Peyman et al. Aug 2001 B1
6302877 Ruiz Oct 2001 B1
6304390 Takanashi Oct 2001 B1
6308590 Berto Oct 2001 B1
6335190 Zhou et al. Jan 2002 B1
6361560 Nigam Mar 2002 B1
6376153 Uchikawa et al. Apr 2002 B2
6387379 Goldberg et al. May 2002 B1
6391230 Sarbadhikari May 2002 B1
6416179 Lieberman et al. Jul 2002 B1
6423093 Hicks et al. Jul 2002 B1
6432246 Blake Aug 2002 B1
6436092 Peyman Aug 2002 B1
6458141 Peyman Oct 2002 B1
6461384 Hoffmann et al. Oct 2002 B1
6469844 Iwase et al. Oct 2002 B1
6480346 Funakoshi Nov 2002 B2
6491637 Foster et al. Dec 2002 B2
6497700 LaHaye Dec 2002 B1
6515006 Horn Feb 2003 B2
6551307 Peyman Apr 2003 B2
6554424 Miller et al. Apr 2003 B1
6554860 Hoffmann et al. Apr 2003 B2
6555103 Leukel et al. Apr 2003 B2
6575573 Lai et al. Jun 2003 B2
6581993 Nigam Jun 2003 B2
6588902 Isogai Jul 2003 B2
6589280 Koziol Jul 2003 B1
6607527 Ruiz et al. Aug 2003 B1
6613088 Babizhayev Sep 2003 B1
6638304 Azar Oct 2003 B2
6649722 Rosenzweig et al. Nov 2003 B2
6655804 Streibig Dec 2003 B2
6692126 Xie et al. Feb 2004 B1
6702807 Peyman Mar 2004 B2
6726322 Andino et al. Apr 2004 B2
6740116 Morcher May 2004 B2
6755858 White Jun 2004 B1
6786926 Peyman Sep 2004 B2
6811256 Becherer et al. Nov 2004 B1
6855163 Peyman Feb 2005 B2
6874886 Miller et al. Apr 2005 B2
6899424 Miller et al. May 2005 B2
6949093 Peyman Sep 2005 B1
6951556 Epstein Oct 2005 B2
6966648 Miller et al. Nov 2005 B2
6989008 Peyman Jan 2006 B2
6997428 Andino et al. Feb 2006 B1
7001374 Peyman Feb 2006 B2
7008447 Koziol Mar 2006 B2
7025455 Roffman Apr 2006 B2
7061693 Zalevsky Jun 2006 B2
7099057 Parker et al. Aug 2006 B2
7276080 Murakami et al. Oct 2007 B2
7287852 Fiala Oct 2007 B2
7364674 Hoover Apr 2008 B1
7399811 Mentak et al. Jul 2008 B2
7404637 Miller et al. Jul 2008 B2
7404638 Miller et al. Jul 2008 B2
7446157 Mentak et al. Nov 2008 B2
7455404 Bandhauer et al. Nov 2008 B2
7455691 Feingold et al. Nov 2008 B2
7462193 Nagamoto Dec 2008 B2
7477452 Tsuruma Jan 2009 B2
7491350 Silvestrini Jan 2009 B2
7497866 Perez Mar 2009 B2
7628810 Christie et al. Dec 2009 B2
7641337 Altmann Jan 2010 B2
7645299 Koziol Jan 2010 B2
7745555 Mentak et al. Jun 2010 B2
7842367 Mentak Nov 2010 B2
7976577 Silvestrini Jul 2011 B2
D645337 Hsu et al. Sep 2011 S
8043371 Paul et al. Oct 2011 B2
8048972 Mentak et al. Nov 2011 B2
8079706 Silvestrini et al. Dec 2011 B2
D656526 Christie et al. Mar 2012 S
8157374 Bandhauer et al. Apr 2012 B2
8241354 Hong et al. Aug 2012 B2
8287592 Silvestrini Oct 2012 B2
8343215 Miller et al. Jan 2013 B2
D681086 Christie et al. Apr 2013 S
8420753 Mentak et al. Apr 2013 B2
8460374 Christie et al. Jun 2013 B2
8604098 Boydston et al. Dec 2013 B2
8740978 Weeber et al. Jun 2014 B2
8752958 Miller et al. Jun 2014 B2
8633292 Hu et al. Jul 2014 B2
8858624 Christie et al. Oct 2014 B2
8864824 Silvestrini et al. Oct 2014 B2
8955968 Zalevsky et al. Feb 2015 B2
9005281 Christie et al. Apr 2015 B2
9138142 Christie et al. Sep 2015 B2
9204962 Silvestrini Dec 2015 B2
9427311 Christie et al. Aug 2016 B2
9427922 Reboul et al. Aug 2016 B2
9492272 Christie et al. Nov 2016 B2
9545303 Vilupuru et al. Jan 2017 B2
9573328 Reboul et al. Feb 2017 B2
9603704 Silvestrini Mar 2017 B2
9757227 Kushlin et al. Sep 2017 B2
9844919 Reboul et al. Dec 2017 B2
9848979 Vilupuru et al. Dec 2017 B2
9943403 Webb et al. Apr 2018 B2
9987127 Bogaert et al. Jun 2018 B2
10004593 Webb Jun 2018 B2
10183453 Reboul et al. Jan 2019 B2
20010027314 Peyman Oct 2001 A1
20010034516 Peyman Oct 2001 A1
20010050750 Breger Dec 2001 A1
20020010510 Silverstrini Jan 2002 A1
20020082288 Horn Jun 2002 A1
20020120329 Lang et al. Aug 2002 A1
20020167640 Francis et al. Nov 2002 A1
20020196409 Jani Dec 2002 A1
20030014042 Juhasz et al. Jan 2003 A1
20030105521 Perez Jun 2003 A1
20030135272 Brady et al. Jul 2003 A1
20030149480 Shadduck Aug 2003 A1
20030204258 Graham et al. Oct 2003 A1
20030216763 Patel Nov 2003 A1
20040019379 Glick et al. Jan 2004 A1
20040056371 Liao et al. Mar 2004 A1
20040068317 Knight Apr 2004 A1
20040106929 Masket Jun 2004 A1
20040140578 Kelly et al. Jul 2004 A1
20050027355 Murakami et al. Feb 2005 A1
20050046794 Silvestrini et al. Mar 2005 A1
20050056954 Devlin Mar 2005 A1
20050090895 Peyman Apr 2005 A1
20050124983 Frey et al. Jun 2005 A1
20050134793 Roffman Jun 2005 A1
20050137703 Chen Jun 2005 A1
20050143751 Makker et al. Jun 2005 A1
20050182488 Peyman Aug 2005 A1
20050187621 Brady Aug 2005 A1
20050288784 Peyman Dec 2005 A1
20060064077 Peyman Mar 2006 A1
20060079959 Christie et al. Apr 2006 A1
20060113054 Silvestrini Jun 2006 A1
20060184243 Yilmaz Aug 2006 A1
20060232665 Schowengerdt et al. Oct 2006 A1
20060235428 Silvestrini Oct 2006 A1
20060235514 Silvestrini Oct 2006 A1
20060241751 Marmo et al. Oct 2006 A1
20060265058 Silvestrini Nov 2006 A1
20060268226 Christie et al. Nov 2006 A1
20060268227 Christie et al. Nov 2006 A1
20060268228 Christie et al. Nov 2006 A1
20060268229 Silvestrini et al. Nov 2006 A1
20060270946 Silvestrini et al. Nov 2006 A1
20060271026 Silvestrini et al. Nov 2006 A1
20060271178 Christie et al. Nov 2006 A1
20060271179 Christie et al. Nov 2006 A1
20060271180 Christie et al. Nov 2006 A1
20060271181 Christie et al. Nov 2006 A1
20060271182 Christie et al. Nov 2006 A1
20060271183 Christie et al. Nov 2006 A1
20060271184 Silvestrini Nov 2006 A1
20060271185 Silvestrini Nov 2006 A1
20060274264 Christie et al. Dec 2006 A1
20060274265 Christie et al. Dec 2006 A1
20070032866 Portney Feb 2007 A1
20070091472 Alkemper et al. Apr 2007 A1
20070092592 Chiang Apr 2007 A1
20070129797 Lang et al. Jun 2007 A1
20070225691 Silvestrini et al. Sep 2007 A1
20080033546 Liang Feb 2008 A1
20080077238 Deacon et al. Mar 2008 A1
20080100921 Nishikawa May 2008 A1
20080151183 Altmann Jun 2008 A1
20080208335 Blum et al. Aug 2008 A1
20080212030 Bentley et al. Sep 2008 A1
20080220214 Uozu et al. Sep 2008 A1
20080221674 Blum et al. Sep 2008 A1
20080255663 Akpek et al. Oct 2008 A1
20080269884 Vannoy Oct 2008 A1
20080306587 Your Dec 2008 A1
20090012505 Chernyak Jan 2009 A1
20090021692 Miller et al. Jan 2009 A1
20090287306 Smith et al. Jan 2009 A1
20090059168 Miller et al. Mar 2009 A1
20090069817 Peyman Mar 2009 A1
20090171458 Kellan et al. Jul 2009 A1
20090204207 Blum et al. Aug 2009 A1
20090222086 Lui et al. Sep 2009 A1
20090234448 Weeber et al. Sep 2009 A1
20090306773 Silvestrini et al. Dec 2009 A1
20100082100 Mikawa Apr 2010 A1
20100127412 Lake May 2010 A1
20100149618 Sprague Jun 2010 A1
20100312336 Hong et al. Dec 2010 A1
20110037184 Shoji et al. Feb 2011 A1
20110040376 Christie Feb 2011 A1
20110051080 Bandhauer et al. Mar 2011 A1
20110125261 Portney May 2011 A1
20110166652 Bogaert et al. Jul 2011 A1
20110172675 Danta et al. Jul 2011 A1
20110245919 Pettit Oct 2011 A1
20110251685 Chu Oct 2011 A1
20120203239 Vukich et al. Aug 2012 A1
20120245683 Christie et al. Sep 2012 A1
20120309761 Chow et al. Dec 2012 A1
20120310338 Christie et al. Dec 2012 A1
20130053953 Silvestrini Feb 2013 A1
20130131795 Miller et al. May 2013 A1
20130147072 Bothe et al. Jun 2013 A1
20130238091 Danta et al. Sep 2013 A1
20130289543 Mordaunt Oct 2013 A1
20140131905 Webb May 2014 A1
20140379078 Trindade Dec 2014 A1
20150025627 Christie et al. Jan 2015 A1
20150073549 Webb et al. Mar 2015 A1
20150177422 Liu et al. Jun 2015 A1
20150183173 Linhardt et al. Jul 2015 A1
20150366658 Christie et al. Dec 2015 A1
20160297107 Shim et al. Oct 2016 A1
20170049560 Cherne Feb 2017 A1
20170143477 Christie et al. May 2017 A1
20170156850 Silvestrini et al. Jun 2017 A1
20180125639 Vilupuru et al. May 2018 A1
20180133990 Reboul et al. May 2018 A1
20180338826 Link et al. Nov 2018 A1
20190076235 Webb et al. Mar 2019 A1
20190076241 Alarcon Heredia et al. Mar 2019 A1
Foreign Referenced Citations (111)
Number Date Country
2004201751 May 2004 AU
1875895 Dec 2006 CN
100368846 Feb 2008 CN
101322663 Dec 2008 CN
101341426 Jul 2012 CN
4134320 Apr 1992 DE
0165652 Dec 1985 EP
0443094 Aug 1991 EP
1173790 Jan 2002 EP
1674049 Jun 2006 EP
1548489 Aug 2006 EP
2319457 May 2011 EP
2243052 Sep 2011 EP
2365379 Sep 2011 EP
2455799 May 2012 EP
2823789 Jan 2015 EP
2364457 Aug 2015 EP
2620687 Mar 1989 FR
2649605 Jan 1991 FR
1276003 Jun 1972 GB
62-167343 Jul 1987 JP
64-002644 Jan 1989 JP
H02-7954 Jan 1990 JP
04-158859 Jun 1992 JP
06-509731 Mar 1993 JP
H05-65340 Sep 1993 JP
06-502782 Mar 1994 JP
H07-067896 Mar 1995 JP
07-265340 Oct 1995 JP
08-103457 Apr 1996 JP
H09-502542 Mar 1997 JP
11-503657 Aug 1997 JP
07-178125 Jul 1998 JP
2000-047145 Feb 2000 JP
2002-537895 Nov 2002 JP
2003-502109 Jan 2003 JP
2004-510199 Apr 2004 JP
2004-538034 Dec 2004 JP
2005-533576 Nov 2005 JP
2007-516794 Jun 2007 JP
2007-523720 Aug 2007 JP
2008-506710 Mar 2008 JP
S59-54527 May 2008 JP
10-0335722 May 2002 KR
2138837 Sep 1999 RU
1380743 Mar 1988 SU
WO 8705797 Oct 1987 WO
WO 9503747 Feb 1995 WO
WO 9508135 Mar 1995 WO
WO 9635397 Nov 1996 WO
WO 9848715 Nov 1998 WO
WO 00025704 May 2000 WO
WO 00038594 Jul 2000 WO
WO 0051682 Sep 2000 WO
WO 0052516 Sep 2000 WO
WO 0070388 Nov 2000 WO
WO 2001010641 Feb 2001 WO
WO 0115779 Mar 2001 WO
WO 0117460 Mar 2001 WO
WO 0119364 Mar 2001 WO
WO 01082815 Nov 2001 WO
WO 02076320 Oct 2002 WO
WO 02102241 Dec 2002 WO
WO 03020177 Mar 2003 WO
WO 03022168 Mar 2003 WO
WO 03061518 Jul 2003 WO
WO 2004014969 Feb 2004 WO
WO 2004034917 Apr 2004 WO
WO 2004105588 Dec 2004 WO
WO 2004113959 Dec 2004 WO
WO 2005082265 Sep 2005 WO
WO 2006020638 Feb 2006 WO
WO 2006047534 May 2006 WO
WO 2006060380 Jun 2006 WO
WO 2006069012 Jun 2006 WO
WO 2006113377 Oct 2006 WO
WO 2006113411 Oct 2006 WO
WO 2006113563 Oct 2006 WO
WO 2006113564 Oct 2006 WO
WO 2007057734 Oct 2007 WO
WO 2007133384 Nov 2007 WO
WO 2007142981 Dec 2007 WO
WO 2008036671 Mar 2008 WO
WO 2008102096 Aug 2008 WO
WO 2009050511 Apr 2009 WO
WO 2009122409 Oct 2009 WO
WO 2009140080 Nov 2009 WO
WO 2009149060 Dec 2009 WO
WO 2010059214 May 2010 WO
WO 2011020074 Feb 2011 WO
WO 2011020078 Feb 2011 WO
WO 2011047076 Apr 2011 WO
WO 2011069059 Jun 2011 WO
WO 2011088107 Jul 2011 WO
WO 2012170066 Dec 2012 WO
WO 2013019871 Feb 2013 WO
WO 2013082545 Jun 2013 WO
WO 2013101793 Jul 2013 WO
WO 2013112589 Aug 2013 WO
WO 2013123265 Aug 2013 WO
WO 2014054946 Apr 2014 WO
WO 2014074610 May 2014 WO
WO 2014158653 Oct 2014 WO
WO 2014164056 Oct 2014 WO
WO 2015021323 Feb 2015 WO
WO 2015069927 May 2015 WO
WO 2015073718 May 2015 WO
WO 2016081493 May 2016 WO
WO 2017062316 Apr 2017 WO
WO 2017091520 Jun 2017 WO
WO 2019010178 Jan 2019 WO
Non-Patent Literature Citations (8)
Entry
Internet Archive Wayback Machine; Aniridia Implants; downloaded from https://web.archive.org/web/20110824062840/http://www.morcher.com/nc/produkte/aniridiaimplants.html (Archived Aug. 24, 2011; printed on Feb. 5, 2015).
Guyton A.C., Textbook of Medical Physiology, 7th Edition, W.B. Saunders Company, Jan. 1986: Chapter 58, in 13 pages.
International Search Report and Written Opinion for PCT/US2010/0455481 dated Dec. 20, 2010 in 20 pages.
International Search Report and Written Opinion for PCT/US2014/050223 dated Nov. 27, 2014 in 14 pages.
Lu Xuequan, et al. “Radiation preparation and thermo-response swelling of interpenetrating polymer network hydrogel composed of PNIPAAm and PMMA”, Radiation Physics and Chemistry, vol. 57, Mar. 2000, pp. 477-480, XP002473596.
Patel, C.K., et al. “Imaging the macula through a black occlusive intraocular lens”. Arch. Ophthalmol. Oct. 2010; 128(10):1374-1376.
Yusuf, et al., “Inability to perform posterior segment monitoring by scanning laser ophthalmoscopy or optical coherence tomography with some occlusive intraocular lenses in clinical use”, J. Cataract Refract. Surg., Mar. 2012, 38: 513-518.
Yusuf, et al., “Occlusive IOLs for Intractable Diplopia Demonstrate a Novel Near-Infrared Window of Transmission for SLO/OCT Imaging and Clinical Assessment”. Investigative Ophthalmology & Visual Science, May 2011, 52(6): 3737-3743.
Related Publications (1)
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20180296322 A1 Oct 2018 US
Provisional Applications (3)
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61233804 Aug 2009 US
61233794 Aug 2009 US
61863833 Aug 2013 US
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Parent 14454585 Aug 2014 US
Child 16017834 US
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Parent 12856492 Aug 2010 US
Child 14454585 US