US20090228101A1 - Intraocular lens with post-implantation adjustment capabilities - Google Patents

Abstract

Disclosed are accommodating intraocular lenses for implantation in an eye having an optical axis. In certain embodiments, an intraocular lens includes an anterior optic, a posterior optic, and a support structure configured to move the optics relative to each other along an optical axis between an accommodated state and an unaccommodated state. In certain embodiments, at least a portion of the support structure can be modified in situ to alter reaction forces between the support structure and at least one structure of the eye. In certain embodiments, a refractive property of one of the anterior or posterior optics can be modified in situ while leaving the refractive properties of the remaining one of the anterior or posterior optics substantially unaffected. Additional embodiments and methods are also disclosed.

Description

RELATED APPLICATION
• This application is related to, and claims the benefit of U.S. Provisional 60/948,170 filed Jul. 5, 2007, the entirety of which is hereby incorporated by reference herein and made a part of the present specification.
BACKGROUND
• 1. Field
• The inventions relate to lenses and, more particularly, to intraocular lenses, the performance of which can be adjusted post-operatively or anytime after implantation in the eye.
• 2. Description of the Related Art
• Cataract operations frequently involve the implantation of an artificial lens following cataract removal. Often, these lenses have a fixed focal length or, in the case of bifocal or multifocal lenses, can have several different fixed focal lengths. Known lenses can suffer from a variety of drawbacks.
SUMMARY
• In some embodiments, a method of modifying an accommodating intraocular lens having an anterior optic, a posterior optic, and a support structure is provided. The method can involve modifying one or more portions of the intraocular lens after implantation (e.g., post-operatively or during a later sate of a procedure) in an eye. In one method, energy can be applied to at least a portion of the support structure to alter reaction forces between the support structure and at least one structure of the eye. In another method, energy can be applied to at least a portion of the anterior optic to alter the power of the optic, e.g., by altering the refractive index thereof. In another method, energy can be applied to at least a portion of the posterior optic to alter the power of the optic, e.g., by altering the refractive index thereof. In another method, energy can be applied to at least a portion of both of the anterior optic and the posterior optic to alter the power of both of the anterior optic and the posterior optic. In another method, energy can be applied to both the support structure and to at least a portion of at least one of the anterior optic and the posterior optic to alter the power of at least one of the optics.
• In some embodiments, a method of modifying an accommodating intraocular lens having a first optic and a second optic after implantation in an eye comprises non-invasively applying energy to at least a portion of the first optic to adjust a refractive property of the first optic while leaving refractive properties of the second optic substantially unaffected. The method can also comprise, in some embodiments, non-invasively applying energy to at least a portion of the second optic to alter refractive properties of the second optic while leaving refractive properties of the first optic substantially unaffected. In some embodiments, a first energy source is applied to the first optic and a second energy source different from the first energy source is applied to the second optic. In some embodiments, the first optic comprises a first material responsive to the first energy source and the second optic comprises a second material responsive to the second energy source.
• In some embodiments, a method of adjusting an intraocular lens having an anterior optic and a posterior optic after implantation in an eye comprises non-invasively applying energy to at least a portion of one of said anterior optic and said posterior optic while the lens is in the eye to alter a refractive property of said one of said optics while leaving refractive properties of a remaining one of said optics substantially unaffected.
• In some embodiments, a method of modifying an accommodating intraocular lens comprising an anterior viewing element and a posterior viewing element comprises applying energy to one or more of the anterior and posterior viewing elements to change the index of refraction of the one or more viewing elements. In some embodiments, applying energy to one of the optics to change the index of refraction of the one optic leaves refractive properties of the remaining optic substantially unaffected.
• In some embodiments, a method of modifying an accommodating intraocular lens comprising an anterior viewing element and a posterior viewing element comprises applying energy to one or more of the anterior and posterior viewing elements to change the shape (e.g., the curvature) of the one or more viewing elements.
• In some embodiments, a method of modifying an accommodating intraocular lens comprising an anterior viewing element and a posterior viewing element comprises applying energy to one or more of the anterior and posterior viewing elements to change the power of the one or more viewing elements.
• In some embodiments, a method of modifying an accommodating intraocular lens comprising an anterior portion having an anterior viewing element and an anterior biasing element and a posterior portion having a posterior viewing element and a posterior biasing element comprises applying energy to one or more of the anterior biasing element and the posterior biasing element to change the stiffness of the one or more biasing elements.
• In some embodiments, a method of modifying an accommodating intraocular lens comprising an anterior portion having an anterior viewing element and an anterior biasing element and a posterior portion having a posterior viewing element and a posterior biasing element comprises applying energy to one or more of the anterior biasing element and the posterior biasing element to change the spring constant of the one or more biasing elements.
• In some embodiments, a method of modifying an accommodating intraocular lens comprising an anterior portion having an anterior viewing element and an anterior biasing element and a posterior portion having a posterior viewing element and a posterior biasing element comprises applying energy to one or more of the anterior biasing element and the posterior biasing element to alter the separation of the anterior and posterior viewing elements, where the separation is that of the viewing elements when the viewing elements are in an unaccommodated state.
• In some embodiments, an accommodating intraocular lens for implantation in an eye has an optical axis. The lens comprises an anterior portion which in turn comprises an anterior viewing element comprised of an optic having refractive power and an anterior biasing element comprising first and second anterior translation members extending from the anterior viewing element. The lens further comprises a posterior portion which in turn comprises a posterior viewing element in spaced relationship to the anterior viewing element and a posterior biasing element comprising first and second posterior translation members extending from the posterior viewing element. The anterior portion and posterior portion meet at first and second apices of the intraocular lens such that a plane perpendicular to the optical axis and passing through the apices is closer to one of said viewing elements than to the other of said viewing elements. The anterior portion and the posterior portion are responsive to force thereon to cause the separation between the viewing elements to change.
• In some embodiments, an accommodating intraocular lens for implantation in an eye has an optical axis. The lens comprises an anterior portion, which in turn comprises an anterior viewing element comprised of an optic having refractive power, and an anterior biasing element comprising first and second anterior translation members extending from the anterior viewing element. The lens further comprises a posterior portion which in turn comprises a posterior viewing element in spaced relationship to the anterior viewing element, and a posterior biasing element comprising first and second posterior translation members extending from the posterior viewing element. The anterior portion and posterior portion meet at first and second apices of the intraocular lens. The anterior portion and the posterior portion are responsive to force thereon to cause the separation between the viewing elements to change. The first anterior translation member forms a first anterior biasing angle, as the lens is viewed from the side, with respect to a plane perpendicular to the optical axis and passing through the apices. The first posterior translation member forms a first posterior biasing angle, as the lens is viewed from the side, with respect to the plane. The first anterior biasing angle and the first posterior biasing angle are unequal.
• In some embodiments, an accommodating intraocular lens comprises an anterior viewing element comprised of an optic having refractive power of less than 55 diopters and a posterior viewing element comprised of an optic having refractive power. The optics provide a combined power of 15-25 diopters and are mounted to move relative to each other along the optical axis in response to a contractile force by the ciliary muscle of the eye upon the capsular bag of the eye. The relative movement corresponds to change in the combined power of the optics of at least one diopter. Alternatively, the accommodating intraocular lens can further comprise a posterior viewing element comprised of an optic having a refractive power of zero to minus 25 diopters.
• In some embodiments, an accommodating intraocular lens comprises an anterior portion which in turn comprises an anterior viewing element which has a periphery and is comprised of an optic having refractive power. The anterior portion further comprises an anterior biasing element comprising first and second anterior translation members extending from the anterior viewing element. The lens further comprises a posterior portion which in turn comprises a posterior viewing element having a periphery, the posterior viewing element being in spaced relationship to the anterior viewing element, and a posterior biasing element comprising first and second posterior translation members extending from the posterior viewing element. The first anterior translation member and the first posterior translation member meet at a first apex of the intraocular lens, and the second anterior translation member and the second posterior translation member meet at a second apex of the intraocular lens, such that force on the anterior portion and the posterior portion causes the separation between the viewing elements to change. Each of the translation members is attached to one of the viewing elements at least one attachment location. All of the attachment locations are further away from the apices than the peripheries of the viewing elements are from the apices.
• In some embodiments, an accommodating intraocular lens comprises an anterior portion comprised of a viewing element. The viewing element is comprised of an optic having refractive power. The lens further comprises a posterior portion comprised of a viewing element. The viewing elements are mounted to move relative to each other along the optical axis in response to force generated by the ciliary muscle of the eye. The lens further comprises a distending portion comprised of a distending member having a fixed end attached to the posterior portion and a free end sized and oriented to distend a portion of the lens capsule such that coupling of forces between the lens capsule and the intraocular lens is modified by the distending portion.
• Some embodiments comprise an accommodating intraocular lens. The lens comprises an anterior portion comprised of an anterior viewing element and an anterior biasing element connected to the anterior viewing element. The anterior viewing element is comprised of an optic having refractive power. The lens further comprises a posterior portion comprised of a posterior viewing element and a posterior biasing element connected to the posterior viewing element. The lens has an optical axis which is adapted to be substantially coincident with the optical axis of the eye upon implantation of the lens. The anterior and posterior viewing elements are mounted to move relative to each other along the optical axis in response to force generated by the ciliary muscle of the eye. The biasing elements are joined at first and second apices which are spaced from the optical axis of the lens. The lens further comprises a distending member extending between the first and second apices.
• In some embodiments, an accommodating intraocular lens comprises an anterior portion comprised of a viewing element. The viewing element is comprised of an optic having refractive power. The lens further comprises a posterior portion comprised of a viewing element. The viewing elements are mounted to move relative to each other along the optical axis in response to force generated by the ciliary muscle of the eye. The lens further comprises a retention portion comprised of a retention member having a fixed end attached to the anterior portion and a free end sized and oriented to contact a portion of the lens capsule such that extrusion of the implanted lens through the lens capsule opening is inhibited.
• Some embodiments comprise an accommodating intraocular lens. The lens comprises an anterior portion comprised of a viewing element, the viewing element comprised of an optic having refractive power, and a posterior portion comprised of a viewing element. The viewing elements are mounted to move relative to each other along the optical axis in response to force generated by the ciliary muscle of the eye. The lens further comprises a distending portion comprised of a distending member attached to one of the portions, and oriented to distend the lens capsule such that the distance between a posterior side of the posterior viewing element and an anterior side of the anterior viewing element along the optical axis is less than 3 mm when the ciliary muscle is relaxed and the lens is in an unaccommodated state.
• Some embodiments comprise an accommodating intraocular lens. The lens comprises an anterior portion comprised of a viewing element, the viewing element comprised of an optic having refractive power, and a posterior portion comprised of a viewing element. The viewing elements are mounted to move relative to each other along the optical axis in response to force generated by the ciliary muscle of the eye. The lens further comprises a distending portion comprised of a distending member attached to one of the portions, and oriented to distend the lens capsule. The distending causes the lens capsule to act on at least one of the posterior and anterior portions such that separation between the viewing elements is reduced when the ciliary muscle is relaxed and the lens is in an unaccommodated state.
• Some embodiments comprise an accommodating intraocular lens. The lens comprises an anterior portion comprised of a viewing element, the viewing element comprised of an optic having refractive power, and a posterior portion comprised of a viewing element. The viewing elements are mounted to move relative to each other along the optical axis in response to force generated by the ciliary muscle of the eye. The lens further comprises a distending member attached to the posterior portion. The distending member is separate from the biasing members and reshapes the lens capsule such that force coupling between the ciliary muscle and the lens is modified to provide greater relative movement between the viewing elements when the lens moves between an unaccommodated state and an accommodated state in response to the ciliary muscle.
• Some embodiments comprise an accommodating intraocular lens. The lens comprises an anterior portion comprised of an anterior viewing element and an anterior biasing element connected to the anterior viewing element, the anterior viewing element being comprised of an optic having refractive power. The lens further comprises a posterior portion comprised of a posterior viewing element and a posterior biasing element connected to the posterior viewing element. The lens has an optical axis which is adapted to be substantially coincident with the optical axis of the eye upon implantation of the lens. The anterior and posterior viewing elements are mounted to move relative to each other along the optical axis in response to force generated by the ciliary muscle of the eye. The biasing elements are joined at first and second apices which are spaced from the optical axis of the lens. The lens further comprises first and second distending members. Each of the members is attached to one of the anterior and posterior portions and extends away from the optical axis. The first member is disposed between the apices on one side of the intraocular lens and the second member is disposed between the apices on the opposite side of the intraocular lens. The distending members are oriented to distend portions of the lens capsule such that the viewing elements are relatively movable through a range of at least 1.0 mm in response to contraction of the ciliary muscle.
• In some embodiments, an accommodating intraocular lens comprises an anterior portion which is in turn comprised of a viewing element. The anterior viewing element is comprised of an optic having a diameter of approximately 3 mm or less and a refractive power of less than 55 diopters. The lens further comprises a posterior portion comprised of a viewing element. The viewing elements are mounted to move relative to each other along the optical axis in response to force generated by the ciliary muscle of the eye. The lens further comprises a distending portion comprised of a distending member having a fixed end attached to the posterior portion and a free end sized and oriented to distend a portion of the lens capsule such that coupling of forces between the lens capsule and the intraocular lens is increased.
• Some embodiments comprise an accommodating intraocular lens. The lens comprises an anterior portion comprised of a viewing element, the anterior viewing element being comprised of an optic having a refractive portion with a refractive power of less than 55 diopters. The lens further comprises a posterior portion comprised of a viewing element. The lens has an optical axis which is adapted to be substantially coincident with the optical axis of the eye upon implantation of the lens. The posterior viewing element comprises an optic arranged substantially coaxially with the anterior optic on the optical axis of the lens. The posterior optic has a larger diameter than the refractive portion of the anterior optic. The posterior optic comprises a peripheral portion having positive refractive power and extending radially away from the optical axis of the lens beyond the periphery of the refractive portion of the anterior optic, so that at least a portion of the light rays incident upon the posterior optic can bypass the refractive portion of the anterior optic.
• Some embodiments comprise an accommodating intraocular lens. The lens comprises an anterior portion comprised of a viewing element, the anterior viewing element being comprised of an optic having a refractive power of less than 55 diopters. The lens further comprises a posterior portion comprised of a viewing element. The lens has an optical axis which is adapted to be substantially coincident with the optical axis of the eye upon implantation of the lens. The posterior viewing element comprises an optic arranged substantially coaxially with the anterior optic on the optical axis of the lens. The posterior optic has a larger diameter than the anterior optic. The posterior optic comprises a peripheral portion having positive refractive power and extending radially away from the optical axis of the lens beyond the periphery of the anterior optic, so that at least a portion of the light rays incident upon the posterior optic can bypass the anterior optic.
• Some embodiments comprise an intraocular lens. The lens comprises an optic and a pair of elongate members extending from the optic. The members are comprised of a shape memory alloy.
• In some embodiments, an accommodating intraocular lens for implantation in an eye has an optical axis and a lens capsule having a capsule opening for receiving the lens. The lens comprises a posterior portion comprised of a posterior viewing element, and an anterior portion comprised of an anterior viewing element. The anterior viewing element is comprised of an optic having refractive power. The viewing elements are mounted to move relative to each other along the optical axis in response to force generated by the ciliary muscle of the eye. The anterior portion is adapted to contact portions of the lens capsule while being spaced from the lens capsule in at least one location so as to provide a fluid flow channel that extends from a region between the viewing elements to a region outside the capsule.
• Some embodiments comprise an accommodating intraocular lens. The lens comprises an anterior portion which in turn comprises an anterior viewing element having a periphery and comprised of an optic having refractive power, and an anterior biasing element comprising at least one anterior translation member attached to a first attachment area on the periphery of the anterior viewing element. The first attachment area has a thickness in a direction substantially perpendicular to the periphery and a width in a direction substantially parallel to the periphery. The ratio of the width to the thickness is equal to or greater than 3.
• In certain embodiments, a method of manufacturing an intraocular lens having anterior and posterior viewing elements arranged along a common optical axis comprises defining an anterior viewing element mold space and a posterior viewing element mold space, arranging the anterior viewing element mold space and the posterior viewing element mold space along a mold axis substantially coincident with the optical axis of the lens, and molding the anterior viewing element in the anterior viewing element mold space while the anterior viewing element mold space and the posterior viewing element mold space are arranged substantially along the mold axis.
• In certain embodiments, a method of preparing an accommodating intraocular lens having an optical axis for subsequent implantation comprises providing an intraocular lens having first and second viewing elements interconnected by plural members. At least a portion of the members are disposed from the optical axis by a distance greater than a periphery of at least one of the viewing elements. This distance is measured orthogonal to the optical axis. The method further comprises drawing the members inwardly toward the optical axis by relatively rotating the first and second viewing elements. In one variation of the method, the first and second viewing elements are relatively rotated about the optical axis.
• In some embodiments, an accommodating intraocular lens comprises an anterior portion having an anterior viewing element, and a posterior portion having a posterior viewing element. The viewing elements are positioned to move relative to each other along an optical axis in response to action of the ciliary muscle of the eye. The anterior and posterior portions comprise a single piece of material.
• In some embodiments, an accommodating intraocular lens comprises first and second optics. At least one of the optics has refractive power. The optics are mounted by an articulated frame to move relative to each other along an optical axis in response to action of a ciliary muscle. The frame is formed of a single piece of material. In one variation of the lens, at least one of the optics is formed of a material which is different from the material of the frame.
• In some embodiments, an accommodating intraocular lens comprises an anterior portion having an anterior viewing element comprising an optic having refractive power. The lens further comprises a posterior portion having a posterior viewing element. The viewing elements are positioned to move relative to each other along an optical axis in response to action of the ciliary muscle of the eye. At least one of the anterior and posterior portions has at least one separation member with a contact surface. The at least one separation member is configured to prevent contact between the anterior viewing element and the posterior viewing element by inhibiting relative movement of the anterior and posterior portions toward each other beyond a minimum separation distance. The contact surface contacts an opposing surface of the intraocular lens over a contact area when the portions are at the minimum separation distance. At least one of the surfaces has an adhesive affinity for the other of the surfaces. The contact area is sufficiently small to prevent adhesion between the surfaces when the anterior portion and the posterior portion are separated by the minimum separation distance. In one variation of the lens, the contact surface and the opposing surface are comprised of the same material.
• In some embodiments, an intraocular lens comprises first and second interconnected viewing elements mounted to move relative to each other along an optical axis in response to action of a ciliary muscle. At least one of the viewing elements includes an optic having refractive power. The lens is formed by the process of providing a first outer mold and a second outer mold, and an inner mold therebetween. The first outer mold and the inner mold define a first mold space, and the second outer mold and the inner mold define a second mold space. The process further comprises molding the viewing elements and the optic as a single piece by filling the first and second mold spaces with a material, such that the first viewing element is formed in the first mold space and the second viewing element is formed in the second mold space. The process further comprises removing the first and second outer molds from the lens while the inner mold remains between the viewing elements, and removing the inner mold from between the viewing elements while the viewing elements remain interconnected.
• In some embodiments, a method of making an intraocular lens having first and second interconnected viewing elements wherein at least one of the viewing elements includes an optic having refractive power comprises providing a first outer mold and a second outer mold, and an inner mold therebetween. The first outer mold and the inner mold define a first mold space, and the second outer mold and the inner mold define a second mold space. The process further comprises molding the viewing elements and the optic as a single piece by filling the first and second mold spaces with a material, such that the first viewing element is formed in the first mold space and the second viewing element is formed in the second mold space. The process further comprises removing the first and second outer molds from the lens while the inner mold remains between the viewing elements, and removing the inner mold from between the viewing elements while the viewing elements remain interconnected. In one variation, providing the inner mold may comprise molding the inner mold. In another variation, the inner mold has a first inner mold face and a second inner mold face opposite the first inner mold face, and providing the inner mold comprises machining the inner mold, which in turn comprises machining the first inner mold face and the second inner mold face in a single piece of material.
• In some embodiments, an accommodating intraocular lens comprises first and second optics. At least one of the optics has refractive power. The optics are mounted to move relative to each other along an optical axis in response to action of a ciliary muscle. The first optic is formed of a first polymer having a number of recurring units including first-polymer primary recurring units, and the second optic is formed of a second polymer having a number of recurring units including second-polymer primary recurring units. No more than about 10 mole percent of the recurring units of the first polymer are the same as the second-polymer primary recurring units and no more than about 10 mole percent of the recurring units of the second polymer are the same as the first-polymer primary recurring units. In one variation, the first optic may comprise an anterior optic, the second optic may comprise a posterior optic, the first polymer may comprise silicone, and the second polymer may comprise acrylic. In another variation, the first optic may comprise an anterior optic, the second optic may comprise a posterior optic, the first polymer may comprise high-refractive-index silicone, and the second polymer may comprise hydrophobic acrylic.
BRIEF DESCRIPTION OF THE DRAWINGS
• Having thus summarized the general nature of the disclosure, certain preferred embodiments and modifications thereof will become apparent to those skilled in the art from the detailed description herein having reference to the figures that follow, of which:
• FIG. 1 is a sectional view of the human eye, with the lens in the unaccommodated state.
• FIG. 2 is a sectional view of the human eye, with the lens in the accommodated state.
• FIG. 3 is a perspective view of one embodiment of an intraocular lens system.
• FIG. 4 is a side view of the lens system.
• FIG. 5 is a rear perspective view of the lens system.
• FIG. 6 is a front view of the lens system.
• FIG. 7 is a rear view of the lens system.
• FIG. 8 is a top view of the lens system.
• FIG. 9 is a side sectional view of the lens system.
• FIG. 10 is a top sectional view of the lens system.
• FIG. 11 is a second perspective view of the lens system.
• FIG. 12 is a third perspective view of the lens system.
• FIG. 13 is a side view of the lens system in the unaccommodated state.
• FIG. 14 is a side sectional view of the lens system in the unaccommodated state.
• FIG. 15 is a top sectional view of the lens system in the unaccommodated state.
• FIG. 16 is a sectional view of the human eye with the lens system implanted in the capsular bag and the lens system in the accommodated state.
• FIG. 17 is a sectional view of the human eye with the lens system implanted in the capsular bag and the lens system in the unaccommodated state.
• FIG. 17A is a sectional view of an arm of the lens system.
• FIG. 17B is a sectional view of another embodiment of the arm of the lens system.
• FIGS. 17C-17L are sectional views of other embodiments of the arm of the lens system.
• FIG. 17M is a side sectional view of another embodiment of the lens system.
• FIG. 17N is a side sectional view of another embodiment of the lens system.
• FIG. 18 is a side view of another embodiment of the lens system.
• FIG. 19 is a side sectional view of another embodiment of the lens system.
• FIG. 20 is a rear perspective view of another embodiment of the lens system.
• FIG. 21 is a partial top sectional view of another embodiment of the lens system, implanted in the capsular bag.
• FIG. 21A is a front view of another embodiment of the lens system.
• FIG. 21B is a front view of another embodiment of the lens system.
• FIG. 21C is a front view of another embodiment of the lens system.
• FIG. 22 is a partial side sectional view of another embodiment of the lens system, implanted in the capsular bag.
• FIG. 22A is a side view of a stop member system employed in one embodiment of the lens system.
• FIG. 23 is a side view of a mold system for forming the lens system.
• FIG. 24 is a side sectional view of the mold system.
• FIG. 25 is a perspective view of a first mold portion.
• FIG. 26 is a perspective view of a second mold portion.
• FIG. 27 is a top view of the second mold portion.
• FIG. 28 is a side sectional view of the second mold portion.
• FIG. 29 is another side sectional view of the second mold portion.
• FIG. 30 is a bottom view of a center mold portion.
• FIG. 31 is a top view of the center mold portion.
• FIG. 32 is a sectional view of the center mold portion.
• FIG. 33 is another sectional view of the center mold portion.
• FIG. 34 is a perspective view of the center mold portion.
• FIG. 34A is a partial cross sectional view of an apex of the lens system, showing a set of expansion grooves formed therein.
• FIG. 35 is a schematic view of another embodiment of the lens system.
• FIG. 36 is a schematic view of another embodiment of the lens system.
• FIG. 37 is a perspective view of another embodiment of the lens system.
• FIG. 38 is a top view of another embodiment of the lens system.
• FIG. 38A is a schematic view of another embodiment of the lens system, as implanted in the capsular bag.
• FIG. 38B is a schematic view of the embodiment ofFIG. 38A, in the accommodated state.
• FIG. 38C is a schematic view of biasers installed in the lens system.
• FIG. 38D is a schematic view of another type of biasers installed in the lens system.
• FIG. 38E is a perspective view of another embodiment of the lens system.
• FIGS. 39A-39B are a series of schematic views of an insertion technique for use in connection with the lens system
• FIG. 40 is a schematic view of fluid-flow openings formed in the anterior aspect of the capsular bag.
• FIG. 40A is a front view of the lens system, illustrating one stage of a folding technique for use with the lens system.
• FIG. 40B is a front view of the lens system, illustrating another stage of the folding technique.
• FIG. 40C illustrates another stage of the folding technique.
• FIG. 40D illustrates another stage of the folding technique.
• FIG. 40E illustrates another stage of the folding technique.
• FIG. 40F illustrates another stage of the folding technique.
• FIG. 40G is a perspective view of a folding tool for use with the lens system.
• FIG. 41 is a sectional view of an aspheric optic for use with the lens system.
• FIG. 42 is a sectional view of an optic having a diffractive surface for use with the lens system.
• FIG. 43 is a sectional view of a low-index optic for use with the lens system.
• FIG. 44 is a side elevation view of another embodiment of the lens system with a number of separation members.
• FIG. 45 is a front elevation view of the lens system ofFIG. 44.
• FIG. 46 is an overhead sectional view of the lens system ofFIG. 44.
• FIG. 47 is an overhead sectional view of the lens system ofFIG. 44, with the viewing elements at a minimum separation distance.
• FIG. 48 is a closeup view of the contact between a separation member and an opposing surface.
• FIG. 49 is a side sectional view of an apparatus and method for manufacturing a center mold.
• FIG. 50 is another side sectional view of the apparatus and method ofFIG. 49.
• FIG. 51 is another side sectional view of the apparatus and method ofFIG. 49.
• FIG. 52 is another side sectional view of the apparatus and method ofFIG. 49.
• FIG. 53 is another side sectional view of the apparatus and method ofFIG. 49.
• FIG. 54 is a side sectional view of the lens system in position on the center mold.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTSI. The Human Eye and Accommodation
• FIGS. 1 and 2 show thehuman eye50 in section. Of particular relevance to the present disclosure are thecornea52, theiris54 and thelens56, which is situated within the elastic, membranous capsular bag orlens capsule58. Thecapsular bag58 is surrounded by and suspended within theciliary muscle60 by ligament-like structures calledzonules62.
• As light enters theeye50, thecornea52 and thelens56 cooperate to focus the incoming light and form an image on theretina64 at the rear of the eye, thus facilitating vision. In the process known as accommodation, the shape of thelens56 is altered (and its refractive properties thereby adjusted) to allow theeye50 to focus on objects at varying distances. A typical healthy eye has sufficient accommodation to enable focused vision of objects ranging in distance from infinity (generally defined as over 20 feet from the eye) to very near (closer than 10 inches).
• Thelens56 has a natural elasticity, and in its relaxed state assumes a shape that in cross-section resembles a football. Accommodation occurs when theciliary muscle60 moves the lens from its relaxed or “unaccommodated” state (shown inFIG. 1) to a contracted or “accommodated” state (shown inFIG. 2). Movement of theciliary muscle60 to the relaxed/unaccommodated state increases tension in thezonules62 andcapsular bag58, which in turn causes thelens56 to take on a thinner (as measured along the optical axis) or taller shape as shown inFIG. 1. In contrast, when theciliary muscle60 is in the contracted/accommodated state, tension in thezonules62 andcapsular bag58 is decreased and thelens56 takes on the fatter or shorter shape shown inFIG. 2. When theciliary muscles60 contract and thecapsular bag58 andzonules62 slacken, some degree of tension is maintained in thecapsular bag58 andzonules62.
II. The Lens System: Structure
• FIGS. 3-17 depict one embodiment of anintraocular lens system100 which is configured for implantation into thecapsular bag58 in place of thenatural lens56, and is further configured to change the refractive properties of the eye in response to the eye's natural process of accommodation. With reference toFIG. 3, a set of axes is included to illustrate the sense of directional terminology which will be used herein to describe various features of thelens system100. The terms “anterior” and “posterior” refer to the depicted directions on the optical axis of thelens100 shown inFIG. 3. When thelens100 is implanted in an eye, the anterior direction extends toward the cornea and the posterior direction extends toward the retina, with the optical axis of the lens substantially coincident with the optical axis of the eye shown inFIGS. 1 and 2. The terms “left” and “right” refer to the directions shown on the lateral axis, which is orthogonal to the optical axis. In addition, the terms “upper” and “lower” refer to the directions depicted on the transverse axis which is orthogonal to both of the optical axis and the lateral axis.
• This system of axes is depicted purely to facilitate description herein; thus, it is not intended to limit the possible orientations which thelens system100 may assume during use. For example, thelens system100 may rotate about, or may be displaced along, the optical axis during use without detracting from the performance of the lens. It is clear that, should thelens system100 be so rotated about the optical axis, the transverse axis may no longer have an upper-lower orientation and the lateral axis may no longer have a left-right orientation, but thelens system100 will continue to function as it would when oriented as depicted inFIG. 3. Accordingly, when the terms “upper,” “lower,” “left” or “right” are used in describing features of thelens system100, such use should not be understood to require the described feature to occupy the indicated position at any or all times during use of thelens system100. Similarly, such use should not be understood to require thelens system100 to maintain the indicated orientation at any or all times during use.
• As best seen inFIG. 4, thelens system100 has ananterior portion102 which is anterior or forward of the line A-A (which represents a plane substantially orthogonal to the optical axis and intersecting first andsecond apices112,116) and aposterior portion104 which is posterior or rearward of the line A-A. Theanterior portion102 comprises ananterior viewing element106 and ananterior biasing element108. Theanterior biasing element108 in turn comprises a firstanterior translation member110 which extends from theanterior viewing element106 to thefirst apex112 and a secondanterior translation member114 which extends from theanterior viewing element106 to thesecond apex116. In the illustrated embodiment the firstanterior translation member110 comprises aright arm110aand aleft arm110b(seeFIG. 3). In addition, the depicted secondanterior translation member114 comprises aright arm114aand aleft arm114b. However, in other embodiments either or both of the first and secondanterior translation members110,114 may comprise a single arm or member, or more than two arms or members.
• As best seen inFIGS. 4,5 and7, theposterior portion104 includes aposterior viewing element118 and aposterior biasing element120. Theposterior biasing element120 includes a firstposterior translation member122 extending from theposterior viewing element118 to thefirst apex112 and a secondposterior translation member124 extending from theposterior viewing element118 to thesecond apex116. In the illustrated embodiment, the first posterior translation member comprises aright arm122aand aleft arm122b. Likewise, the depicted secondposterior translation member124 comprises aright arm124aand aleft arm124b. However, in other embodiments either or both of the first and secondposterior translation members122,124 may comprise a single arm or member, or more than two arms or members.
• In the embodiment shown inFIG. 4, theanterior biasing element108 and the posterior biasing element are configured symmetrically with respect to the plane A-A as thelens system100 is viewed from the side. As used herein to describe the biasingelements108,120, “symmetric” or “symmetrically” means that, as thelens system100 is viewed from the side, the firstanterior translation member110 and the firstposterior translation member122 extend from thefirst apex112 at substantially equal first anterior and posterior biasing angles θ₁, θ₂with respect to the line A-A (which, again, represents the edge of a plane which is substantially orthogonal to the optical axis and intersects the first andsecond apices112,116) and/or that the secondanterior translation member114 and the secondposterior translation member124 extend from thesecond apex116 at substantially equal second anterior and posterior biasing angles θ₃, θ₄with respect to the line A-A. Alternative or asymmetric configurations of the biasing elements are possible, as will be discussed in further detail below. It should be further noted that a symmetric configuration of the biasingelements108,120 does not dictate symmetric positioning of the viewing elements with respect to the line A-A; in the embodiment shown inFIG. 4 theanterior viewing element106 is closer to the line A-A than is the posterior viewing element.
• Preferably, both theanterior viewing element106 and theposterior viewing element118 comprise an optic or lens having refractive power. (As used herein, the term “refractive” or “refractive power” shall include “diffractive” or “diffractive power”.) As discussed herein, in some embodiments, an intraocular lens such as thelens system100 is configured to be modified post-operatively and in situ to change a performance characteristic of the system. For example, one or more of theviewing elements106,118 can be configured to be modifiable post-operatively to alter the power of the one or more viewing elements and/or the lens system, as discussed further below. In some embodiments, the support structures of thelens system100 are configured to be modified post-operatively and in situ to change one or more performance characteristics of the support structures, such as the spring rate of the biasing members. The preferred power ranges for the optics are discussed in detail below.
• In alternative embodiments one or both of the anterior andposterior viewing elements106,118 may comprise an optic with a surrounding or partially surrounding perimeter frame member or members, with some or all of the biasing elements/translation members attached to the frame member(s). As a further alternative, one of theviewing elements106,118 may comprise a perimeter frame with an open/empty central portion or void located on the optical axis (seeFIG. 20 and discussion below), or a perimeter frame member or members with a zero-power lens or transparent member therein. In still further variations, one of theviewing elements106,118 may comprise only a zero-power lens or transparent member.
• In a presently preferred embodiment, aretention portion126 is coupled to theanterior portion102, preferably at theanterior viewing element106. Theretention portion126 preferably includes afirst retention member128 and asecond retention member130, although in alternative embodiments theretention portion126 may be omitted altogether, or may comprise only one retention member or more than two retention members. Thefirst retention member128 is coupled to theanterior viewing element106 at afixed end128aand also includes afree end128bopposite thefixed end128a. Likewise, thesecond retention member130 includes afixed end130aand afree end130b. Theretention members128,130 are illustrated as being coupled to theanterior viewing element106 at the upper and lower edges thereof; however, theretention members128,130 may alternatively be attached to theanterior viewing element106 at other suitable edge locations.
• In the preferred embodiment, theposterior portion104 includes a distendingportion132, preferably attached to theposterior viewing element118. Thepreferred distending portion132 includes afirst distending member134 which in turn includes afixed end134a, afree end134bopposite thefixed end134aand preferably also includes anopening134cformed therein. Thepreferred distending portion132 also comprises asecond distending member136 with afixed end136a, afree end136band preferably anopening136cformed therein. In alternative embodiments, the distendingportion132 may be omitted altogether, or may comprise a single distending member or more than two distending members. To optimize their effectiveness, the preferred location for the distendingmembers134,136 is 90 degrees away (about the optical axis) from theapices112,116 on theposterior portion104. Where the biasing elements form more than two apices (or where two apices are not spaced 180 degrees apart about the optical axis), one or more distending members may be positioned angularly midway between the apices about the optical axis. Alternatively, the distending member(s) may occupy other suitable positions relative to the apices (besides the “angularly midway” positions disclosed above); as further alternatives, the distending member(s) may be located on theanterior portion102 of thelens system100, or even on the apices themselves. The functions of theretention portion126 and the distendingportion132 will be described in greater detail below.
III. The Lens System: Function/Optics
• The anterior and posterior biasingelements108,120 function in a springlike manner to permit theanterior viewing element106 andposterior viewing element118 to move relative to each other generally along the optical axis. The biasingelements108,120 bias theviewing elements106,118 apart so that theelements106,108 separate to the accommodated position or accommodated state shown inFIG. 4. Thus, in the absence of any external forces, the viewing elements are at their maximum separation along the optical axis. Theviewing elements106,118 of thelens system100 may be moved toward each other, in response to a ciliary muscle force of up to 2 grams, to provide an unaccommodated position by applying appropriate forces upon the anterior andposterior portions102,104 and/or theapices112,116.
• When thelens system100 is implanted in the capsular bag58 (FIGS. 16-17) the above described biasing forces cause thelens system100 to expand along the optical axis so as to interact with both the posterior and anterior aspects of the capsular bag. Such interaction occurs throughout the entire range of motion of theciliary muscle60. At one extreme the ciliary muscle is relaxed and thezonules62 pull thecapsular bag58 radially so as to cause the bag to become more disk shaped. The anterior and posterior sides of the bag, in turn, apply force to the anterior andposterior portions102,104 of thelens system100, thereby forcing theviewing elements106,118 toward each other into the accommodated position. At the other extreme, the ciliary muscle contracts and thezonules62 move inwardly to provide slack in thecapsular bag58 and allow the bag to become more football-shaped. The slack in the bag is taken up by the lens system due to the biasing-apart of the anterior andposterior viewing elements106,118. As the radial tension in the bag is reduced, theviewing elements106,118 move away from each other into an accommodated position. Thus, the distance between theviewing elements106,118 depends on the degree of contraction or relaxation of theciliary muscle60. As the distance between the anterior andposterior viewing elements106,118 is varied, the focal length of thelens system100 changes accordingly. Thus, when thelens system100 is implanted into the capsular bag (seeFIGS. 16-17) thelens system100 operates in conjunction with the natural accommodation processes of the eye to move between the accommodated (FIG. 16) and unaccommodated (FIG. 17) states in the same manner as would a healthy “natural” lens. Preferably, thelens system100 can move between the accommodated and unaccommodated states in less than about one second.
• Theentire lens system100, other than the optic(s), thus comprises an articulated frame whose functions include holding the optic(s) in position within the capsular bag and guiding and causing movement of the optic(s) between the accommodated and unaccommodated positions.
• Advantageously, theentire lens system100 may comprise a single piece of material, i.e. one that is formed without need to assemble two or more components by gluing, heat bonding, the use of fasteners or interlocking elements, etc. This characteristic increases the reliability of thelens system100 by improving its resistance to material fatigue effects which can arise as the lens system experiences millions of accommodation cycles throughout its service life. It will be readily appreciated that the molding process and mold tooling discussed herein, lend themselves to the molding oflens systems100 that comprise a single piece of material. However, any other suitable technique may be employed to manufacture single-piece lens systems.
• In those embodiments where the optic(s) are installed into annular or other perimeter frame member(s) (see discussion below), the articulated frame may comprise a single piece of material, to obtain the performance advantages discussed above. It is believed that the assembly of the optic(s) to the articulated frame will not substantially detract from the achievement of these advantages.
• Thelens system100 has sufficient dynamic range that the anterior andposterior viewing elements106,118 move about 0.5-4 mm, preferably about 1-3 mm, more preferably about 1-2 mm, and most preferably about 1.5 mm closer together when thelens system100 moves from the accommodated state to the unaccommodated state. In other words the separation distance X (seeFIGS. 9-10,14-15) between the anterior andposterior viewing elements106,118, which distance may for present purposes be defined as the distance along the optical axis (or a parallel axis) between a point of axial intersection with the posterior face of theanterior viewing element106 and a point of axial intersection with the anterior face of theposterior viewing element118, decreases by the amount(s) disclosed above upon movement of thelens system100 to the unaccommodated state. Simultaneously, in the preferred mode the total system thickness Y decreases from about 3.0-4.0 mm in the accommodated state to about 1.5-2.5 mm in the unaccommodated state.
• As may be best seen inFIG. 6, the firstanterior translation member110 connects to theanterior viewing element106 via connection of the left andright arms110a,110bto first andsecond transition members138,140 atattachment locations142,144. The secondanterior translation member114 connects to theanterior viewing element106 via connection of left andright arms114a,114bto the first andsecond transition members138,140 atattachment locations146,148. This is a presently preferred arrangement for the first and secondanterior translation members110,114; alternatively, the first and secondanterior translation members110,114 could be connected directly to theanterior viewing element106, as is the case with the connection of the first and secondposterior translation members122,124 to theposterior viewing element118.
• However the connection is established between the first and secondanterior translation members110,114 and theanterior viewing element106, it is preferred that theattachment locations142,144 corresponding to the firstanterior translation member110 be farther away from thefirst apex112 than is the closest edge or the periphery of theanterior viewing element106. This configuration increases the effective length of the firstanterior translation member110/arms110a,110b, in comparison to a direct or straight attachment between the apex112 and the nearest/top edge of theanterior viewing element106. For the same reasons, it is preferred that theattachment locations146,148 associated with the secondanterior translation member114 be farther away from thesecond apex116 than is the closest/bottom edge of theanterior viewing element106.
• As best seen inFIG. 7, the firstposterior translation member122 is preferably connected directly to theposterior viewing element118 via attachment of the left andright arms122a,122bto theelement118 at attachment points150,152. Likewise, the secondposterior translation member124 is preferably directly connected to theposterior viewing element118 via connection of the left andright arms124a,124bto theelement118 at attachment points154,156, respectively. In alternative embodiments, the first and secondposterior translation members124,122 can be connected to the posterior viewing element via intervening members as is done with theanterior viewing element106. No matter how these connections are made, it is preferred that theattachment locations150,152 be spaced further away from thefirst apex112 than is the nearest edge or the periphery of theposterior viewing element118. Similarly, it is preferred that theattachment locations154,156 be spaced further away from thesecond apex116 than is the closest edge of theposterior viewing element118.
• By increasing the effective length of some or all of thetranslation members110,114,122,124 (and that of thearms110a,110b,114a,114b,122a,122b,124a,124bwhere such structure is employed), the preferred configuration of theattachment locations142,144,146,148,150,152,154,156 relative to the first andsecond apices112,116 enables the anterior and/orposterior viewing elements106,118 to move with respect to one another a greater distance along the optical axis, for a given angular displacement of the anterior and/or posterior translation members. This arrangement thus facilitates a more responsive spring system for thelens system100 and minimizes material fatigue effects associated with prolonged exposure to repeated flexing.
• In the illustrated embodiment, theattachment location142 of the firstanterior translation member110 is spaced from thecorresponding attachment location146 of the secondanterior translation member114 along the periphery of the anterior viewing element, and the same relationship exists between the other pairs ofattachment locations144,148;150,154; and152,156. This arrangement advantageously broadens the support base for the anterior andposterior viewing elements106,118 and prevents them from twisting about an axis parallel to the lateral axis, as the viewing elements move between the accommodated and unaccommodated positions.
• It is also preferred that theattachment locations142,144 of the firstanterior translation member110 be located equidistant from thefirst apex112, and that the right and leftarms110a,110bof themember110 be equal in length. Furthermore, the arrangement of theattachment locations146,148,arms114a,114band second apex preferably mirrors that recited above regarding the firstanterior translation member110, while theapices112,116 are preferably equidistant from the optical axis and are situated 180 degrees apart. This configuration maintains theanterior viewing element106 orthogonal to the optical axis as theviewing element106 moves back and forth and the anterior viewing element flexes.
• For the same reasons, a like combination of equidistance and equal length is preferred for the first and secondposterior translation members122,124 and theirconstituent arms122a,122b,124a,124band attachment points150,152,154,156, with respect to theapices112,116. However, as shown thearms122a,122b,124a,124bneed not be equal in length to theircounterparts110a,110b,114a,114bin the first and secondanterior translation members110,114.
• Where any member or element connects to the periphery of the anterior orposterior viewing elements106,118, the member defines a connection geometry or attachment area with a connection width W and a connection thickness T (seeFIG. 4 and the example illustrated therein, of the connection of the secondposterior translation member124 to the posterior viewing element118). For purposes of clarity, the connection width is defined as being measured along a direction substantially parallel to the periphery of the viewing element in question, and the connection thickness is defined as measured along a direction substantially perpendicular to the periphery of the viewing element. (The periphery itself is deemed to be oriented generally perpendicular to the optical axis as shown inFIG. 4.) Preferably, no attachment area employed in thelens system100 has a ratio of width to thickness less than 3. It has been found that such a geometry reduces distortion of the viewing element/optic due to localized forces. For the same reasons, it is also preferred that each of thetranslation members110,114,122,124 be connected to the periphery of the respective viewing elements at least two attachment areas, each having the preferred geometry discussed above.
• FIGS. 17A and 17B show two preferred cross-sectional configurations which may be used along some or all of the length of the translation members and/orarms110a,110b,114a,114b,122a,122b,124a,124b. The shape is defined by a relatively broad and flat or slightly curvedouter surface182. It is intended that when in use the outer surface faces away from the interior of the lens system and/or toward thecapsular bag58. The remaining surfaces, proportions and dimensions making up the cross-sectional shape can vary widely but may advantageously be selected to facilitate manufacture of thelens system100 via molding or casting techniques while minimizing stresses in the arms during use of the lens system.
• FIGS. 17C-17L depict a number of alternative cross-sectional configurations which are suitable for the translation members and/orarms110a,110b,114a,114b,122a,122b,124a,124b. As shown, a wide variety of cross-sectional shapes may be used, but preferably any shape includes the relatively broad and flat or slightly curvedouter surface182.
• It is further contemplated that the dimensions, shapes, and/or proportions of the cross-sectional configuration of the translation members and/orarms110a,110b,114a,114b,122a,122b,124a,124bmay vary along the length of the members/arms. This may be done in order to, for example, add strength to high-stress regions of the arms, fine-tune their spring characteristics, add rigidity or flexibility, etc.
• As discussed above, each of theanterior viewing element106 and theposterior viewing element118 preferably comprises an optic having refractive power. In one preferred embodiment, theanterior viewing element106 comprises a biconvex lens having positive refractive power and theposterior viewing element118 comprises a convexo-concave lens having negative refractive power. Theanterior viewing element106 may comprise a lens having a positive power advantageously less than 55 diopters, preferably less than 40 diopters, more preferably less than 35 diopters, and most preferably less than 30 diopters. Theposterior viewing element118 may comprise a lens having a power which is advantageously between −25 and 0 diopters, and preferably between −25 and −15 diopters. In other embodiments, theposterior viewing element118 comprises a lens having a power which is between −15 and 0 diopters, preferably between −13 and −2 diopters, and most preferably between −10 and −5 diopters. Advantageously, the total power of the optic(s) employed in thelens system100 is about 5-35 diopters; preferably, the total power is about 10-30 diopters; most preferably, the total power is about 15-25 diopters. (As used herein, the term “diopter” refers to lens or system power as measured when thelens system100 has been implanted in the human eye in the usual manner.) It should be noted that if materials having a high index of refraction (e.g., higher than that of silicone) are used, the optics may be made thinner which facilitates a wider range of motion for the optics. This in turn allows the use of lower-power optics than those specified above. In addition, higher-index materials allow the manufacture of a higher-power lens for a given lens thickness and thereby reduce the range of motion needed to achieve a given range of accommodation.
• Some lens powers and radii of curvature presently preferred for use with an embodiment of thelens system100 with optic(s) having a refractive index of about 1.432 are as follows: a +31 diopter, biconvex lens with an anterior radius of curvature of 5.944 mm and a posterior radius of curvature of 5.944 mm; a +28 diopter, biconvex lens with an anterior radius of curvature of 5.656 mm and a posterior radius of curvature of 7.788 mm; a +24 diopter, biconvex lens with an anterior radius of curvature of 6.961 mm and a posterior radius of curvature of 8.5 mm; a −10 diopter, biconcave lens with an anterior radius of curvature of 18.765 mm and a posterior radius of curvature of 18.765 mm; a −8 diopter, concavo-convex lens with an anterior radius of curvature of between 9 mm and 9.534 mm and a posterior radius of curvature of 40 mm; and a −5 diopter, concavo-convex lens with an anterior radius of curvature of between 9 mm and 9.534 mm and a posterior radius of curvature of 20 mm. In one embodiment, the anterior viewing element comprises the +31 diopter lens described above and the posterior viewing element comprises the −10 diopter lens described above. In another embodiment, the anterior viewing element comprises the +28 diopter lens described above and the posterior viewing element comprises the −8 diopter lens described above. In another embodiment, the anterior viewing element comprises the +24 diopter lens described above and the posterior viewing element comprises the −5 diopter lens described above.
• The combinations of lens powers and radii of curvature specified herein advantageously minimize image magnification. However, other designs and radii of curvature provide modified magnification when desirable.
• The lenses of theanterior viewing element106 and theposterior viewing element118 are relatively moveable as discussed above; advantageously, this movement is sufficient to produce an accommodation of at least one diopter, preferably at least two diopters and most preferably at least three diopters. In other words, the movement of the optics relative to each other and/or to the cornea is sufficient to create a difference between (i) the refractive power of the user's eye in the accommodated state and (ii) the refractive power of the user's eye in the unaccommodated state, having a magnitude expressed in diopters as specified above. Where thelens system100 has a single optic, the movement of the optic relative to the cornea is sufficient to create a difference in focal power as specified above.
• Advantageously, thelens system100 in one embodiment can be customized for an individual patient's needs by shaping or adjusting only one of the four lens faces, and thereby altering the overall optical characteristics of thesystem100. This in turn facilitates easy manufacture and maintenance of an inventory of lens systems with lens powers which will fit a large population of patients, without necessitating complex adjustment procedures at the time of implantation. It is contemplated that all of the lens systems in the inventory have a standard combination of lens powers, and that a system is fitted to a particular patient by simply shaping only a designated “variable” lens face. This custom-shaping procedure can be performed to-order at a central manufacturing facility or laboratory, or by a physician consulting with an individual patient. In one embodiment, the anterior face of the anterior viewing element is the designated sole variable lens face. In another embodiment, the anterior face of the posterior viewing element is the only variable face. However, any of the lens faces is suitable for such designation. The result is minimal inventory burden with respect to lens power (all of the lens systems in stock have the same lens powers) without requiring complex adjustment for individual patients (only one of the four lens faces is adjusted in the fitting process). In another embodiment, any of the four faces of the two lens system can be customized after implantation, as discussed herein.
IV. The Lens System: Alternative Embodiments
• FIG. 17M depicts another embodiment of thelens system100 in which theanterior viewing element106 comprises an optic with a smaller diameter than theposterior viewing element118, which comprises an optic with a peripheral positive-lens portion170 surrounding a centralnegative portion172. This arrangement enables the user of thelens system100 to focus on objects at infinity, by allowing the (generally parallel) light rays incident upon the eye from an object at infinity to bypass theanterior viewing element106. The peripheral positive-lens portion170 of theposterior viewing element118 can then function alone in refracting the light rays, providing the user with focused vision at infinity (in addition to the range of visual distances facilitated by the anterior and posterior viewing elements acting in concert). In another embodiment, theanterior viewing element106 comprises an optic having a diameter of approximately 3 millimeters or less. In yet another embodiment, theanterior viewing element106 comprises an optic having a diameter of approximately 3 millimeters or less and a refractive power of less than 55 diopters, more preferably less than 30 diopters. In still another embodiment, the peripheral positive-lens portion170 has a refractive power of about 20 diopters.
• FIG. 17N shows an alternative arrangement in which, theanterior viewing element106 comprises an optic having acentral portion176 with refractive power, and a surroundingperipheral region174 having a refractive power of substantially zero, wherein thecentral region176 has a diameter smaller than the optic of theposterior viewing element118, and preferably has a diameter of less than about 3 millimeters. This embodiment also allows some incident light rays to pass the anterior viewing element (though the zero-power peripheral region174) without refraction, allowing the peripheral positive-lens portion170posterior viewing element118 to function alone as described above.
• FIGS. 18 and 19 depict anotherembodiment250 of the intraocular lens. It is contemplated that, except as noted below, thisembodiment250 is largely similar to the embodiment disclosed inFIGS. 3-17. Thelens250 features ananterior biasing element108 andposterior biasing element120 which are arranged asymmetrically as thelens system100 is viewed from the side. As used herein to describe the biasingelements108,120, “asymmetric” or “asymmetrically” means that, as thelens system100 is viewed from the side, the firstanterior translation member110 and the firstposterior translation member122 extend from thefirst apex112 at unequal first anterior and posterior biasing angles δ₁, δ₂with respect to the line B-B (which represents the edge of a plane which is substantially orthogonal to the optical axis and intersects the first andsecond apices112,116) and/or that the secondanterior translation member114 and the secondposterior translation member124 extend from thesecond apex116 at substantially equal second anterior and posterior biasing angles δ₃, δ₄with respect to the line B-B.
• In the embodiment shown inFIGS. 18-19, the first and second anterior biasing angles δ₁, δ₃are greater than the corresponding first and second posterior biasing angles δ₂, δ₄. This arrangement advantageously maintains theposterior viewing element118 andapices112,116 in a substantially stationary position. Consequently, the moving mass of thelens system250 is reduced, and theanterior viewing element106 can move more quickly over a wider range along the optical axis under a given motive force. (Note that even where theposterior biasing element120 and its constituent first and secondposterior translation members122,124 are substantially immobile, they are nonetheless “biasing elements” and “translation members” as those terms are used herein.) In another embodiment, theanterior biasing element108 andposterior biasing element120 are arranged asymmetrically in the opposite direction, i.e. such that the first and second anterior biasing angles δ₁, δ₃are smaller than the corresponding first and second posterior biasing angles δ₂, δ₄. This arrangement also provides for a wider range of relative movement of the viewing elements, in comparison to a “symmetric” system.
• It should be further noted that theviewing elements106,118 shown inFIGS. 18-19 are asymmetrically positioned in that theposterior viewing element118 is closer to the line B-B than is theanterior viewing element106. It has been found that this configuration yields desirable performance characteristics irrespective of the configuration of the biasingelements108,120. In alternative embodiments, theviewing elements106,118 may be positioned symmetrically with respect to the line B-B, or they may be positioned asymmetrically with theanterior viewing element106 closer to the line B-B than the posterior viewing element118 (seeFIG. 4 wherein the line in question is denoted A-A). Furthermore, the symmetry or asymmetry of the biasing elements and viewing elements can be selected independently of each other.
• FIG. 20 shows another embodiment350 of an intraocular lens in which theposterior viewing element118 comprises an annular frame member defining a void therein, while theanterior viewing element106 comprises an optic having refractive power. Alternatively, theposterior viewing element118 could comprise a zero power lens or a simple transparent member. Likewise, in another embodiment theanterior viewing element106 could comprise an annular frame member with a void therein or a simple zero power lens or transparent member, with theposterior viewing element118 comprising an optic having refractive power. As a further alternative, one or both of the anterior andposterior viewing elements106,118 may comprise an annular or other perimeter frame member which can receive a removable optic (or a “one-time install” optic) with an interference type fit and/or subsequent adhesive or welding connections. Such a configuration facilitates assembly and/or fine-tuning of the lens system during an implantation procedure, as will be discussed in further detail below.
V. The Lens System: Additional Features
• FIG. 21 depicts the function of the distendingportion132 in greater detail. Thelens system100 is shown situated in thecapsular bag58 in the customary manner with theanterior viewing element106 andposterior viewing element118 arranged along the optical axis. Thecapsular bag58 is shown with a generally circularanterior opening66 which may often be cut into the capsular bag during installation of thelens system100. The first and second distendingmembers134,136 of the distendingportion132 distend thecapsular bag58 so that intimate contact is created between the posterior face of the posterior viewing element and/or theposterior biasing element120. In addition, intimate contact is facilitated between the anterior face of theanterior viewing element106 and/oranterior biasing element108. The distendingmembers134,136 thus remove any slack from thecapsular bag58 and ensure optimum force coupling between thebag58 and thelens system100 as thebag58 is alternately stretched and released by the action of the ciliary muscle.
• Furthermore, the distendingmembers134,136 reshape thecapsular bag58 into a taller, thinner configuration along its range of accommodation to provide a wider range of relative motion of theviewing elements106,118. When thecapsular bag58 is in the unaccommodated state, the distendingmembers134,136 force the capsular bag into a thinner configuration (as measured along the optical axis) in comparison to the unaccommodated configuration of thecapsular bag58 with the natural lens in place. Preferably, the distendingmembers134,136 cause thecapsular bag58 to taken on a shape in the unaccommodated state which is about 1.0-2.0 mm thinner, more preferably about 1.5 mm thinner, along the optical axis than it is with the natural lens in place and in the unaccommodated state.
• With such a thin “starting point” provided by the distendingmembers134,136, theviewing elements106,118 of the lens system can move a greater distance apart, and provide a greater range of accommodation, without causing undesirable contact between the lens system and the iris. Accordingly, by reshaping the bag as discussed above the distendingmembers134,136 facilitate a range of relative motion of the anterior andposterior viewing elements106,118 of about 0.5-4 mm, preferably about 1-3 mm, more preferably about 1-2 mm, and most preferably about 1.5 mm.
• The distendingportion132/distendingmembers134,136 are preferably separate from the anterior and posterior biasingelements108,120; the distendingmembers134,136 thus preferably play no part in biasing the anterior andposterior viewing elements106,118 apart toward the accommodated position. This arrangement is advantageous because theapices112,116 of the biasingelements108,120 reach their point of minimum protrusion from the optical axis (and thus the biasing elements reach their minimum potential effectiveness for radially distending the capsular bag) when thelens system100 is in the accommodated state (seeFIG. 16), which is precisely when the need is greatest for a taut capsular bag so as to provide immediate response to relaxation of the ciliary muscles. The preferred distending portion is “static” (as opposed to the “dynamic” biasingmembers108,120 which move while urging theviewing elements106,118 to the accommodated position or carrying the viewing elements to the unaccommodated position) in that its member(s) protrude a substantially constant distance from the optical axis throughout the range of motion of theviewing elements106,118. Although some degree of flexing may be observed in the distendingmembers134,136, they are most effective when rigid. Furthermore, the thickness and/or cross-sectional profile of the distendingmembers134/136 may be varied over the length of the members as desired to provide a desired degree of rigidity thereto.
• The distendingportion132/distendingmembers132,134 advantageously reshape thecapsular bag58 by stretching thebag58 radially away from the optical axis and causing thebag58 to take on a thinner, taller shape throughout the range of accommodation by the eye. This reshaping is believed to facilitate a broad (as specified above) range of relative motion for the viewing elements of thelens system100, with appropriate endpoints (derived from the total system thicknesses detailed above) to avoid the need for unacceptably thick optic(s) in the lens system.
• If desired, the distendingmembers134,136 may also function as haptics to stabilize and fixate the orientation of thelens system100 within the capsular bag. Theopenings134c,136cof thepreferred distending members134,136 permit cellular ingrowth from the capsular bag upon positioning of thelens system100 therein. Finally, other methodologies, such as a separate capsular tension ring or the use of adhesives to glue the capsular bag together in selected regions, may be used instead of or in addition to the distendingportion132, to reduce “slack” in the capsular bag.
• A tension ring can also act as a physical barrier to cell growth on the inner surface of the capsular bag, and thus can provide additional benefits in limiting posterior capsule opacification, by preventing cellular growth from advancing posteriorly on the inner surface of the bag. When implanted, the tension ring firmly contacts the inner surface of the bag and defines a circumferential barrier against cell growth on the inner surface from one side of the barrier to another.
• FIG. 21A shows an alternative configuration of the distendingportion132, in which the distendingmembers134,136 comprise first and second arcuate portions which connect at either end to theapices112,116 to form therewith an integral perimeter member. In this arrangement it is preferred that the distending members and apices form an oval with height I smaller than width J.
• FIG. 21B shows another alternative configuration of the distendingportion132, in whicharcuate rim portions137 interconnect theapices112,116 and the free ends134b,136bof the distendingmembers134,136. Thus is formed an integral perimeter member with generally higher lateral rigidity than the arrangement depicted inFIG. 21A.
• FIG. 21C shows another alternative configuration of the distendingportion132, in which the distendingmembers134,136 are integrally formed with the first and secondposterior translation members122,124. The distendingmembers134,136 andtranslation members122,124 thus formcommon transition members139 which connect to the periphery of theposterior viewing element118.
• FIG. 22 shows the function of theretention portion126 in greater detail. It is readily seen that the first andsecond retention members128,130 facilitate a broad contact base between the anterior portion of thelens system100 and the anterior aspect of thecapsular bag58. By appropriately spacing the first andsecond retention members128,130, the members prevent extrusion of theanterior viewing element106 through theanterior opening66. It is also readily seen that where contact occurs between the anterior aspect of thecapsular bag58 and one or both of theretention members128,130, the retention members also participate in force coupling between thebag58 and thelens system100 as the bag is stretched and released by the action of the ciliary muscles.
• As best seen inFIGS. 21 and 22, theanterior portion102 of thelens system100 forms a number of regions of contact with thecapsular bag58, around the perimeter of theanterior viewing element106. In the illustrated embodiment, at least some of these regions of contact are located on the anteriormost portions of theanterior biasing element108, specifically at thetransition members138,140, and at theretention members128,130. The transition members and the retention members define spaces therebetween at the edges of theanterior viewing element106 to permit fluid to flow between the interior of thecapsular bag58 and the portions of the eye anterior of thebag58. In other words, the anterior portion of thelens system100 includes at least one location which is spaced from and out of contact with thecapsular bag58 to provide a fluid flow channel extending from the region between theviewing elements106,118 to the exterior of thebag58. Otherwise, if theanterior portion102 of thelens system100 seals theanterior opening66 of thebag58, the resulting prevention of fluid flow can cause the aqueous humor in the capsular bag to stagnate, leading to a clinically adverse event, and can inhibit the movement of thelens system100 between the accommodated and unaccommodated states.
• If desired, one or both of theretention members128,130 may have anopening129 formed therein to permit fluid flow as discussed above. (SeeFIG. 21A.)
• Theretention members128,130 and thetransition members138,140 also prevent contact between the iris and theanterior viewing element106, by separating theanterior opening66 from the anterior face of theviewing element106. In other words, theretention members128,130 and thetransition members138,140 displace the anterior aspect of thecapsular bag58, including theanterior opening66, anteriorly from theanterior viewing element106, and maintain this separation throughout the range of accommodation of the lens system. Thus, if contact occurs between the iris and the lens system-capsular bag assembly, no part of the lens system will touch the iris, only the capsular bag itself, in particular those portions of thebag58 overlying theretention members128,130 and/or thetransition members138,140. Theretention members128,130 and/or thetransition members138,140 therefore maintain a separation between the iris and the lens system, which can be clinically adverse if the contacting portion(s) of the lens system are constructed from silicone.
• As depicted inFIG. 22A, one or more stop members orseparation members190 may be located where appropriate on the anterior and/or posterior biasingelements108,120 to limit the convergent motion of the anterior andposterior viewing elements106,118, and preferably prevent contact therebetween. As thelens system100 moves toward the unaccommodated position, the stop member(s) located on theanterior biasing element108 come into contact with the posterior biasing element120 (or with additional stop member(s) located on thereon), and any stop member(s) located on theposterior biasing element120 come into contact with the anterior biasing element108 (or with additional stop member(s) located thereon). Thestop members190 thus define a point or state of maximum convergence (in other words, the unaccommodated state) of thelens system100/viewing elements106,118. Such definition advantageously assists in setting one extreme of the range of focal lengths which the lens system may take on (in those lens systems which include two or more viewing elements having refractive power) and/or one extreme of the range of motion of thelens system100.
• Thestop members190 shown inFIG. 22A are located on the first and secondanterior translation members110,114 of theanterior biasing element108 and extend posteriorly therefrom. When the anterior andposterior viewing elements106,118 move together, one or more of thestop members190 will contact the posterior translation member(s)122,124, thereby preventing further convergent motion of theviewing elements106,118. Of course, in other embodiments the stop member(s)190 can be in any suitable location on thelens system100.
• FIGS. 44-48 depict another embodiment of thelens system100 having a number of stop members orseparation members190. In this embodiment thestop members190 includeposts190aandtabs190b, although it will be apparent that any number or combination of suitable shapes may be employed for thestop members190. Each of thestop members190 has at least onecontact surface191, one or more of which abuts an opposing surface of thelens system100 when the anterior andposterior viewing elements106,118 converge to a minimum separation distance SD (seeFIG. 47). In the embodiment shown, one or more of the contact surfaces191 of theposts190aare configured to abut an opposing surface defined by a substantially flatanterior perimeter portion193 of theposterior viewing element118, when theviewing elements106,118 are at the minimum separation distance SD. One or more of the contact surfaces191 of thetabs190bare configured to abut opposing surfaces defined by substantially flat anterior faces195 of the distendingmembers134,136, only if theviewing elements106,118 are urged together beyond the minimum separation distance SD. This arrangement permits thetabs190bto function as secondary stop members should theposts190afail to maintain separation of the viewing elements.
• In other embodiments all of the contact surfaces191 of theposts190aandtabs190bmay be configured to contact their respective opposing surfaces when theviewing elements106,118 are at the minimum separation distance SD. In still further embodiments, the contact surfaces191 of thetabs190bmay be configured to contact the opposing surfaces when theviewing elements106,118 are at the minimum separation distance SD and the contact surfaces191 of theposts190aconfigured to contact the opposing surfaces only if theviewing elements106,118 are urged together beyond the minimum separation distance SD. In one embodiment, the minimum separation distance SD is about 0.1-1.0 mm; in another embodiment the minimum separation distance SD is about 0.5 mm.
• When one of the contact surfaces abuts one of the opposing surfaces, the two surfaces define a contact area CA (seeFIG. 48, depicting an example of a contact area CA defined when thecontact surface191 of apost190acontacts an opposing surface defined by theperimeter portion193 of the posterior viewing element118). Preferably, the contact surface and opposing surface are shaped to cooperatively minimize the size of the contact area, to prevent adhesion between the contact surface and the opposing surface, which is often a concern when one or both of these surfaces has an adhesive affinity for the other. In the embodiment shown, this non-adhesive characteristic is achieved by employing a substantiallyhemispherical contact surface191 and a substantially flat opposing surface (perimeter portion193). Of course, other configurations can be selected for the contact surface(s)191, including conical, frustoconical, hemicylindrical, pyramidal, or other rounded, tapered or pointed shapes. All of these configurations minimize the contact area CA while permitting the cross-sectional area CS of the stop member190 (such as thepost190adepicted) to be made larger than the contact area CA, to impart sufficient strength to the stop member despite the relatively small contact area CA. Indeed, when constructing the contact surface(s)191 any configuration may be employed which defines a contact area CA which is smaller than the cross-sectional area CS of thestop member190. As further alternatives, the contact surface(s)191 may be substantially flat and the opposing surface(s) may have a shape which defines, upon contact with the opposing surface, a contact area CA which is smaller than the cross-sectional area CS of the stop member. Thus, the opposing surface(s) may have, for example, a hemispherical, conical, frustoconical, hemicylindrical, pyramidal, or other rounded, tapered or pointed shape.
• Other design features of thestop members190 can be selected to maximize their ability to prevent adhesion of the contact surface(s) to the corresponding opposing surface(s), or adhesion to each other of any part of the anterior andposterior portions102,104 of thelens system100. For example, the contact and opposing surfaces may be formed from dissimilar materials to reduce the effect of any self-adhesive materials employed in forming thelens system100. In addition the shape and/or material employed in constructing one or more of thestop members190 can be selected to impart a spring-like quality to the stop member(s) in question, so that when the stop member is loaded in compression as the viewing elements are urged together at the minimum separation distance, the stop member tends to exert a resisting spring force, due to either bending or axial compression (or both) of the stop member, which in turn derive from the elasticity of the material(s) from which the stop member is constructed, or the shape of the stop member, or both. This springlike quality is particularly effective for inhibiting adhesion of areas of the anterior andposterior portions102,104 other than the contact surface(s) and opposing surface(s).
• As used herein, the term “adhesion” refers to attachment to each other of (i) an area of theanterior portion102 of thelens system100 and (ii) a corresponding area of the posterior portion104 (other than theapices112,116), wherein such attachment is sufficiently strong to prevent, other than momentarily, the anterior andposterior viewing elements106,118 from moving apart along the optical axis under the biasing force of the anterior and/or posterior biasingelements108,120. If the areas in question are formed of different materials, adhesion may occur where at least one of the materials has an adhesive affinity for the other material. If the areas in question are formed of the same material, adhesion may occur where the material has an adhesive affinity for itself.
• In the embodiment shown, fourposts190aare positioned near the perimeter of theanterior viewing element106, equally angularly spaced around the optical axis. In addition, twotabs190bare located on either side of the anterior viewing element, midway between theapices112,116 of the lens system. Naturally, the number, type and/or position of thestop members190 can be varied while preserving the advantageous function of maintaining separation between the anterior and posterior portions of the lens system.
• The illustrated embodiment employs stopmembers190 which extend posteriorly from theanterior portion102 of thelens system100, so that the contact surfaces191 are located on the posterior extremities of thestop members190 and are configured to abut opposing surfaces formed on theposterior portion104 of thelens system100. However, it will be appreciated that some or all of thestop members190 may extend anteriorly from theposterior portion104 of thelens system100, so that theircontact surfaces191 are located on the anterior extremities of thestop members190 and are configured to abut opposing surfaces formed on theanterior portion102 of thelens system100.
VI. Mold Tooling
• FIGS. 23-34 depict amold system500 which is suitable for molding thelens system100 depicted inFIG. 3-17. Themold system500 generally comprises afirst mold502, asecond mold504 and acenter mold506. Thecenter mold506 is adapted to be positioned between thefirst mold502 and thesecond mold504 so as to define a mold space for injection molding or compression molding thelens system100. Themold system500 may be formed from suitable metals, high-impact-resistant plastics or a combination thereof, and can be produced by conventional machining techniques such as lathing or milling, or by laser or electrical-discharge machining. The mold surfaces can be finished or modified by sand blasting, etching or other texturing techniques.
• Thefirst mold502 includes afirst mold cavity508 with a firstanterior mold face510 surrounded by anannular trough512 and a firstperimeter mold face514. Thefirst mold502 also includes aprojection516 which facilitates easier mating with thesecond mold504.
• Thecenter mold506 includes a firstcenter mold cavity518 which cooperates with thefirst mold cavity508 to define a mold space for forming theanterior portion102 of thelens system100. The firstcenter mold cavity518 includes a centralanterior mold face520 which, upon placement of thecenter mold506 in thefirst mold cavity508, cooperates with the firstanterior mold face510 to define a mold space for theanterior viewing element106. In so doing, the firstanterior mold face510 defines the anterior face of theanterior viewing element106 and the centralanterior mold face520 defines the posterior face of theanterior viewing element106. In fluid communication with the chamber formed by the firstanterior mold face510 and the centralanterior mold face520 arelateral channels522,524 (best seen inFIG. 31) which form spaces for molding the first andsecond transition members138,140, along with thearms110a,110bof the firstanterior translation member110 as well as thearms114a,114bof the secondanterior translation member114. The firstcenter mold cavity518 also includesretention member cavities526,528 which define spaces for molding the first andsecond retention members128,130 to theanterior viewing element106.
• Thesecond mold504 includes asecond mold cavity530 with a secondposterior mold space532, a generallycylindrical transition534 extending therefrom and connecting to a secondperimeter mold face536.Lateral notches538,540 (best seen inFIGS. 26 and 27) are formed in the secondperimeter mold face536. Thesecond mold504 also includes aninput channel542 connected to aninput channel opening544 for introducing material into themold system500. Also formed in thesecond mold504 is anoutput channel546 and anoutput channel opening548. A generallycylindrical rim550 is included for mating with theprojection516 of thefirst mold502.
• Thecenter mold506 includes a secondcenter mold cavity552 which cooperates with thesecond mold cavity530 to define a mold space for theposterior portion104 of thelens system100. The secondcenter mold cavity552 includes a centralposterior mold face554 which, upon placement of thecenter mold506 in engagement with thesecond mold cavity530, cooperates with the secondposterior mold face532 and thetransition534 to define a chamber for forming theposterior viewing element118. In fluid communication with the chamber formed by the centralposterior mold face554 and the secondposterior mold face532 arelateral channels556,558,560,562 which provide a mold space for forming thearms122a,122bof the firstposterior translation member122 and thearms124a,124bof the secondposterior translation member124. The secondcenter mold cavity552 includeslateral projections564,566 which coact with thenotches538,540 formed in thesecond mold cavity530. The chambers formed therebetween are in fluid communication with the chamber defined by the centralposterior mold face554 and the secondposterior mold face532 to form the first and second distendingmembers134,136 integrally with theposterior viewing element118.
• Thecenter mold506 includes a first reduced-diameter portion568 and a second reduced-diameter portion570 each of which, upon assembly of themold system500, defines a mold space for theapices112,116 of thelens system100.
• In use, themold system500 is assembled with thecenter mold506 positioned between thefirst mold502 and thesecond mold504. Once placed in this configuration, themold system500 is held together under force by appropriate techniques, and lens material is introduced into themold system500 via theinput channel542. The lens material then fills the space defined by thefirst mold502,second mold504, and thecenter mold506 to take on the shape of thefinished lens system100.
• Themold system500 is then disassembled, and in one embodiment thelens system100 is left in position on thecenter mold506 after removal of the first andsecond molds502,504. This technique has been found to improve the effectiveness of any polishing/tumbling/deflashing procedures which may be performed (see further discussion below). Whether or not these or any other additional process steps are performed, thelens system100 is preferably removed from thecenter mold506 while maintaining the interconnection of the various components of thelens system100.
• In another embodiment, thelens system100 or a portion thereof is formed by a casting or liquid-casting procedure in which one of the first or second molds is first filled with a liquid and the center mold is placed then into engagement with the liquid-filled mold. The exposed face of the center mold is then filled with liquid and the other of the first and second molds is placed into engagement with the rest of the mold system. The liquid is allowed or caused to set/cure and a finished casting may then removed from the mold system.
• Themold system500 can advantageously be employed to produce alens system100 as a single, integral unit (in other words, as a single piece of material). Alternatively, various portions of thelens system100 can be separately molded, casted, machined, etc. and subsequently assembled to create a finished lens system. Assembly can be performed as a part of centralized manufacturing operations; alternatively, a physician can perform some or all of the assembly before or during the implantation procedure, to select lens powers, biasing members, system sizes, etc. which are appropriate for a particular patient.
• Thecenter mold506 is depicted as comprising an integral unit with first and secondcenter mold cavities518,552. Alternatively, thecenter mold506 may have a modular configuration whereby the first andsecond mold cavities518,552 may be interchangeable to adapt thecenter mold506 for manufacturing alens system100 according to a desired prescription or specification, or to otherwise change the power(s) of the lenses made with the mold. In this manner the manufacture of a wide variety of prescriptions may be facilitated by a set of mold cavities which can be assembled back-to-back or to opposing sides of a main mold structure.
• FIGS. 49-53 depict one embodiment of a method for manufacturing thecenter mold506. First, a cylindrical blank1500 formed from any material (such as Ultem) suitable for use in the mold tooling, is loaded into aholder1502 as shown inFIG. 49. Theholder1502 has amain chamber1504 which has an inner diameter substantially similar to that of the blank1500, a smaller-diametersecondary chamber1506 rearward of themain chamber1504, and apassage1508 located rearward of thesecondary chamber1506 and further defined by anannulus1510. The holder also includes two or more holder bores1512 which facilitate attachment of theholder1502 to a blocker (discussed in further detail below). The blank is “blocked” in the holder by filling thesecondary chamber1506 andpassage1508 with water-soluble wax1514.
• Once the blank1500 has been loaded and blocked into theholder1502, theholder1502 is secured to ablocker1516 by bolts or pins (not shown) which fit snugly into the holder bores1512. The holder bores1512 align precisely with corresponding blocker bores1517, by virtue of a snug fit between the blocker bores1517 and the bolts/pins. The blocker-holder assembly is then loaded into a conventional machine tool, such as a lathe and/or a mill, and one of the first and secondcenter mold cavities518,552 (thesecond cavity552 is depicted inFIG. 51) is machined from the exposed face of the blank1500 using conventional machining techniques. Theholder1502 and blank1500, with the secondcenter mold cavity552 formed thereon, are then removed from theblocker1516 as shown inFIG. 51.
• Themain chamber1504 is then filled with water-soluble wax1520 forward of the secondcenter mold cavity552, and thewax1514 is removed from thesecondary chamber1506 and thepassage1508. Next theholder1502 is fixed to theblocker1516 with the as-yet unmodified portion of the blank1500 facing outward. Upon re-loading the holder-blocker assembly into the machine tool, a portion of theannulus1510 is then cut away to facilitate tool access to the blank1500. A series of machining operations are then performed on the blank1500 until the remaining mold cavity (the firstcenter mold cavity518 is depicted inFIG. 53) has been formed. The completedcenter mold506 may then be removed from theholder1502.
• The machining technique depicted inFIGS. 49-53 is advantageous in that it facilitates fabrication of the center mold506 (with both the first and secondcenter mold cavities518,552) from a single piece of material. While it is possible to machine the first and secondcenter mold cavities518,552 from separate pieces of material which are subsequently glued together, such assembly creates a seam in the center mold which can retain contaminants and introduce those contaminants into the mold when forming thelens system100. In addition, the assembly of thecenter mold506 from two halves introduces errors wherein the first and secondcenter mold cavities518,552 may be angularly shifted with respect to each other about the optical axis, or wherein themold cavities518,552 are non-concentric (i.e., shifted with respect to each other in a direction orthogonal to the optical axis). The method depicted inFIGS. 49-53 eliminates these problems by retaining the blank1500 in theholder1502 throughout the fabrication process and by enforcing precise axial alignment, via forced alignment of thebores1512 with the blocker bores1517, when machining of both mold cavities.
• In another embodiment, thecenter mold506 is formed by a molding process rather than by machining. Thecenter mold506 may be molded from any of the materials disclosed herein as suitable for forming thelens system100 itself, including but not limited to silicone, acrylics, polymethylmethacrylate (PMMA), block copolymers of styrene-ethylene-butylene-styrene (C-FLEX) or other styrene-base copolymers, polyvinyl alcohol (PVA), polyurethanes, hydrogels or any other moldable polymers or monomers.
• The lens system which is formed when employing the moldedcenter mold506 may itself be molded from the same material as thecenter mold506. For example, thecenter mold506 may be molded from silicone, and then thelens system100 may be molded from silicone by using themold system500 with the moldedsilicone center mold506.
• Thecenter mold506 can be molded by any suitable conventional techniques. A polished, optical quality initial mold set can be used to make center molds which in turn will produce lens systems with optical quality surfaces on the posterior face of the anterior optic, and the anterior face of the posterior optic. Alternatively (or additionally), the molded center mold can be polished and/or tumbled to produce an optically-accurate center mold.
• The moldedcenter mold506 offers several advantages over a machined center mold. First, it is quicker, cheaper and easier to produce the center mold in large quantities by molding instead of machining. This in turn facilitates leaving the lens system in position on the center mold (seeFIG. 54) while the lens system is tumbled, polished and/or deflashed, without incurring undue expense. The presence of the center mold between the optics increases the effectiveness of the tumbling/polishing/deflashing by increasing the hoop strength of the lens system, so that the energy of the impacting tumbling beads is not dissipated in macroscopic deformation of the lens system. Molding also permits softer materials to be employed in forming the center mold, and a softer center mold is more resistant to damage from deflashing tools and processes, resulting in fewer center molds lost to such process-related damage.
VII. Materials and Adjustability
• Preferred materials for forming thelens system100 include silicone, acrylics, polymethylmethacrylate (PMMA), block copolymers of styrene-ethylene-butylene-styrene (C-FLEX) or other styrene-base copolymers, polyvinyl alcohol (PVA), polyurethanes, hydrogels or any other suitable polymers or monomers. In addition, any portion of thelens system100 other than the optic(s) may be formed from stainless steel or a shape-memory alloy such as nitinol or any iron-based shape-memory alloy. Metallic components may be coated with gold to increase biocompatibility. Where feasible, material of a lower Shore A hardness such as15A may be used for the optic(s), and material of higher hardness such as35A may be used for the balance of thelens system100. Finally, the optic(s) may be formed from a photosensitive silicone to facilitate post-implantation power adjustment as taught in U.S. patent application Ser. No. 09/416,044, filed Oct. 8, 1999, titled LENSES CAPABLE OF POST-FABRICATION POWER MODIFICATION, the entire contents of which are hereby incorporated by reference herein.
• Methyl-methylacrylate monomers may also be blended with any of the non-metallic materials discussed above, to increase the lubricity of the resulting lens system (making the lens system easier to fold or roll for insertion, as discussed further below). The addition of methyl-methylacrylate monomers also increases the strength and transparency of the lens system.
• The optics and/or the balance of thelens system100 can also be formed from layers of differing materials. The layers may be arranged in a simple sandwich fashion, or concentrically. In addition, the layers may include a series of polymer layers, a mix of polymer and metallic layers, or a mix of polymer and monomer layers. In particular, a nitinol ribbon core with a surrounding silicone jacket may be used for any portion of thelens system100 except for the optics; an acrylic-over-silicone laminate may be employed for the optics. A layered construction may be obtained by pressing/bonding two or more layers together, or deposition or coating processes may be employed.
• Where desired, the anterior optic may be formed from a material different from that used to form the posterior optic. This may be done to take advantage of differences between the respective materials in refractive index, mechanical properties or resistance to posterior capsule opacification (“PCO”), or to achieve an appropriate balance of mechanical and optical properties. Additionally, the use of differing materials can increase resistance to intra-lenticular opacification (“ILO”). For example, the material forming the posterior optic may be selected for its resistance to PCO, and/or for its rigidity (so as to form a relatively rigid base for the biasing action of the biasingelements108,120, thereby maximizing anterior displacement of the anterior biasing element). Thus, the posterior optic may be formed from acrylic; for example, a hydrophobic acrylic. The material forming the anterior optic may be selected for its high index of refraction, to keep to a minimum the size and weight of the anterior optic (and the lens system as a whole), thereby maximizing the range and speed of motion of the anterior optic in response to a given biasing force. To achieve these properties the anterior optic may be formed from silicone; for example, high-refractive-index silicones (generally, silicones with a refractive index greater than about 1.43, or silicones with a refractive index of about 1.46).
• In other embodiments, the anterior optic may be formed from any suitable material (including those disclosed herein), and the posterior optic may be formed from any suitable material (including those disclosed herein) other than the material chosen to form the anterior optic. In one embodiment the anterior optic is formed from silicone and the posterior optic is formed from acrylic; in another embodiment the anterior optic is formed from acrylic and the posterior optic is formed from silicone.
• The optics may be considered to be formed from different polymeric materials where no more than about 10 mole percent of recurring units of the polymer employed in the anterior optic are the same as the primary recurring units of the polymer employed in the posterior optic; and/or where no more than about 10 mole percent of recurring units of the polymer employed in the posterior optic are the same as the primary recurring units of the polymer employed in the anterior optic. In general, these conditions are desirable in order for the two materials to have sufficiently different material properties. As used herein, a “primary” recurring unit of a given polymer is the recurring unit which is present in such polymer in the greatest quantity by mole percentage.
• In another embodiment, the optics may be considered to be formed from different polymeric materials where no more than about 10 mole percent of recurring units of the polymer employed in the anterior optic are of the same type as the primary recurring units of the polymer employed in the posterior optic; and/or where no more than about 10 mole percent of the recurring units of the polymer employed in the posterior optic are of the same type as the primary recurring units of the polymer employed in the anterior optic. As used herein, recurring units of the same “type” are in the same chemical family (i.e., having the same or similar functionality) or where the backbone of the polymers formed by such recurring units is essentially the same.
• In one embodiment, portions of thelens system100 other than the optic(s) are formed from a shape-memory alloy. This embodiment takes advantage of the exceptional mechanical properties of shape-memory alloys and provides fast, consistent, highly responsive movement of the optic(s) within the capsular bag while minimizing material fatigue in thelens system100. In one embodiment, one or both of the biasingelements108,120 are formed from a shape-memory alloy such as nitinol or any iron-based shape-memory alloy. Due to the flat stress-strain curve of nitinol, such biasing elements provide a highly consistent accommodation force over a wide range of displacement. Furthermore, biasing elements formed from a shape-memory alloy, especially nitinol, retain their spring properties when exposed to heat (as occurs upon implantation into a human eye) while polymeric biasing elements tend to lose their spring properties, thus detracting from the responsiveness of the lens system. For similar reasons, it is advantageous to use shape-memory alloys such as those discussed above in forming any portion of a conventional (non-accommodating) intraocular lens, other than the optic.
• Where desired, various coatings are suitable for components of thelens system100. A heparin coating may be applied to appropriate locations on thelens system100 to prevent inflammatory cell attachment (ICA) and/or posterior capsule opacification (PCO); naturally, possible locations for such a coating include theposterior biasing element120 and the posterior face of theposterior viewing element118. Coatings can also be applied to thelens system100 to improve biocompatibility; such coatings include “active” coatings like P-15 peptides or RGD peptides, and “passive” coatings such as heparin and other mucopolysaccharides, collagen, fibronectin and laminin. Other coatings, including hirudin, teflon, teflon-like coatings, PVDF, fluorinated polymers, and other coatings which are inert relative to the capsular bag may be employed to increase lubricity at locations (such as the optics and distending members) on the lens system which contact the bag, or Hema or silicone can be used to impart hydrophilic or hydrophobic properties to thelens system100.
• It is also desirable subject thelens system100 and/or the mold surfaces to a surface passivation process to improve biocompatibility. This may be done via conventional techniques such as chemical etching or plasma treatment.
• Furthermore, appropriate surfaces (such as the outer edges/surfaces of the viewing elements, biasing elements, distending members, retention members, etc.) of thelens system100 can be textured or roughened to improve adhesion to the capsular bag. This may be accomplished by using conventional procedures such as plasma treatment, etching, dipping, vapor deposition, mold surface modification, etc. As a further means of preventing ICA/PCO, a posteriorly-extending perimeter wall (not shown) may be added to theposterior viewing element118 so as to surround the posterior face of the posterior optic. The wall firmly engages the posterior aspect of the capsular bag and acts as a physical barrier to the progress of cellular ingrowth occurring on the interior surface of the capsular bag. Finally, the relatively thick cross-section of the preferred anterior viewing element118 (seeFIGS. 9,10) ensures that it will firmly abut the posterior capsule with no localized flexing. Thus, with its relatively sharp rim, the posterior face of the preferredposterior viewing element118 can itself serve as a barrier to cellular ingrowth and ICA/PCO. In order to achieve this effect, theposterior viewing element118 is preferably made thicker than conventional intraocular lenses. As an alternative or supplement to a thick posterior viewing element, cell growth may be inhibited by forming a pronounced, posteriorly-extending perimeter rim on the posterior face of theposterior viewing element118. Upon implantation of thelens system100, the rim firmly abuts the inner surface of thecapsular bag58 and acts as a physical barrier to cell growth between the posterior face of theposterior viewing element118 and thecapsular bag58.
• The selected material and lens configuration should be able to withstand secondary operations after molding/casting such as polishing, cleaning and sterilization processes involving the use of an autoclave, or ethylene oxide or radiation. After the mold is opened, the lens should undergo deflashing, polishing and cleaning operations, which typically involve a chemical or mechanical process, or a combination thereof. Suitable mechanical processes include tumbling, shaking and vibration; a tumbling process may involve the use of a barrel with varying grades of glass beads, fluids such as alcohol or water and polishing compounds such as aluminum oxides. Process rates are material dependent; for example, a tumbling process for silicone should utilize a 6″ diameter barrel moving at 30-100 RPM. It is contemplated that several different steps of polishing and cleaning may be employed before the final surface quality is achieved.
• In one embodiment, thelens system100 is held in a fixture to provide increased separation between, and improved process effect on, the anterior and posterior viewing elements during the deflashing/polishing/cleaning operations. In another embodiment, thelens system100 is everted or turned “inside-out” so that the inner faces of the viewing elements are better exposed during a portion of the deflashing/polishing/cleaning.FIG. 34A shows a number ofexpansion grooves192 which may be formed in the underside of theapices112,116 of thelens system100 to facilitate eversion of thelens system100 without damaging or tearing the apices or the anterior/posterior biasing elements108,120. For the same reasons similar expansion grooves may be formed on the opposite sides (i.e., the outer surfaces) of theapices112,116 instead of or in addition to the location of grooves on the underside.
• A curing process may also be desirable in manufacturing thelens system100. If the lens system is produced from silicone entirely at room temperature, the curing time can be as long as several days. If the mold is maintained at about 50 degrees C., the curing time is reduced to about 24 hours; if the mold is preheated to 100-200 degrees C. the curing time can be as short as about 3-15 minutes. Of course, the time-temperature combinations vary for other materials.
• In certain embodiments, it can be desirable to alter one or more properties of alens system100 after thesystem100 has been implanted in theeye50 of a patient. For example, it can be desirable to correct for errors of ocular length and corneal curvature that may be made prior to implantation, improper positioning of thesystem100 during implantation, and/or changes to the system100 (e.g., movement of the system100) that may occur after implantation as the patient heals. In some embodiments, some or all of thesystem100 can be modified moments, hours, days, weeks, or years after thesystem100 has been implanted. The adjustments or modifications can occur non-invasively, such as without cutting theeye50 in order to access thelens system100, and/or can occur without physical manipulation of thesystem100. Advantageously, such adjustments can allow a patient to approach or achieve ideal vision (e.g., emmetropia) without glasses or other corrective lenses. In further advantageous embodiments, thesystem100 permits accommodation, and can be adjusted to improve near and/or distant vision. In some situations, thelens system100 can be modified post-operatively to improve near vision by inducing myopia in a patient. In some embodiments, thesystem100 can be modified in multiple stages, and can permit adjustments as the patient ages.
• In some embodiments, some or all of thesystem100 can be modified after the system has been implanted in the eye and before the patient has been released. In some embodiments, some or all of the system can be modified after a period of healing has occurred. For example, some or all of thesystem100 may be modified 1, 2, 4, 6, or 8 weeks or more after implantation. In some embodiments, some or all of thesystem100 may be modified after it is has been determined that the eye's healing is substantially complete or that the patient's vision has substantially stabilized.
• In certain embodiments, the shape and/or refractive properties of one or more of theviewing elements106,118 of thelens system100 are altered in situ. In some embodiments, energy is applied to one or more of theelements106,118 to make the alterations without damaging surrounding ocular structures. Energy can also be applied to stabilize the material of which theelements106,118 are constructed, or to substantially prevent further changes to the molecular structure of the material, such as further polymerization due to exposure to normal light conditions or other forms of energy. For example, in some embodiments, the power of some or all of the refractive components of thelens system100 can be changed (e.g., made more positive or more negative) by application of focused energy, and then “locked in” by application of additional energy to prevent further unwanted changes to the power of thesystem100.
• In some embodiments, one or more of theviewing elements106,118 can comprise a composition capable of curing, undergoing stimulus-induced polymerization, or otherwise being induced to change properties in situ. Some suitable compositions are disclosed in U.S. Pat. Nos. 6,749,632, titled APPLICATION OF WAVEFRONT SENSOR TO LENSES CAPABLE OF POST-FABRICATION POWER MODIFICATION; 7,074,840, titled LIGHT ADJUSTABLE LENSES CAPABLE OF POST-FABRICATION POWER MODIFICATION VIA MULTI-PHOTON PROCESSES; 7,134,755, titled CUSTOMIZED LENSES; 6,917,416, titled LIGHT ADJUSTABLE ABERRATION CONJUGATOR; and 7,119,894, titled LIGHT ADJUSTABLE ABERRATION CONJUGATOR, the entire contents of each of which are hereby incorporated by reference herein and made a part of this specification. For example, in various embodiments, one or more of theviewing elements106,118 (and/or some or all of the remainder of the lens system100) can comprise polyacrylates such as polyalkyl acrylates and polyhydroxyalkyl acrylates; polymethacrylates such as polymethyl methacrylate (“PMMA”), a polyhydroxyethyl methacrylate (“PHEMA”), and polyhydroxypropyl methacrylate (“HPMA”); polyvinyls such as polystyrene and polyvinylpyrrolidone (“NVP”); polysiloxanes such as polydimethylsiloxane; polyphosphazenes, and copolymers of thereof. Other suitable materials are disclosed in U.S. Pat. No. 4,260,725, titled HYDROPHILIC CONTACT LENS MADE FROM POLYSILOXANES WHICH ARE THERMALLY BONDED TO POLYMERIZABLE GROUPS AND WHICH CONTAIN HYDROPHILIC SIDECHAINS, and in the patents and references cited therein; the entire contents of each of the foregoing items are incorporated by reference herein and made a part of this specification.
• In certain embodiments, polymerization is induced by application of delivery of energy, or energetic radiation, to theviewing elements106,118. In some embodiments, the radiation comprises electromagnetic radiation having a single wavelength or a relatively small band of wavelengths, and may be provided by a laser or a light emitting diode. In other embodiments, the electromagnetic radiation comprises a band of wavelengths, and may include optical, ultraviolet, or infrared radiation. Other forms of radiation can also be used, including electron beam, microwave, radio frequency, or acoustic. Some suitable polymerization methods, including specific wavelengths and power levels that can be used, are disclosed in U.S. Pat. No. 7,105,110, titled DELIVERY SYSTEM FOR POST-OPERATIVE POWER ADJUSTMENT OF ADJUSTABLE LENS, the entire contents of which are hereby incorporated by reference herein and made a part of this specification.
• In some embodiments, polymerization of theelements106,118 can alter the refractive properties (e.g., the index of refraction) of theelements106,118. In further embodiments, polymerization of theelements106,118 can alter their shape (e.g., curvature). The refractive properties and/or shape of one or more of theelements106,118 thus can be modified to adjust the optical power of theelements106,118. Also, the shape (e.g., curvature), index of refraction, refractive power, or other performance metric of any of the anterior or posterior surfaces of either of the anterior orposterior viewing elements106,118 can be modified to achieve the desired outcome.
• In some embodiments, radiation is initially applied to only a portion of one or more of theelements106,118. The radiation can be directed to or focused on a particular region of theelements106,118 and can polymerize the region to modify the refractive properties and/or shape thereof. In further embodiments, radiation is applied to the remaining portion(s) of the element orelements106,118 to polymerize, stabilize, or substantially prevent changes to the properties of the remaining portion(s).
• In some instances, one or more of theelements106,118 may already comprise the desired optical properties prior to polymerization. For example, once a patient has healed from an implantation procedure, it may be determined that thesystem100 provides proper focusing of incoming light over a full range of accommodation. Accordingly, in some embodiments, it may be desirable to cure or polymerize one or more of theelements106,118 substantially without changing the optical properties (e.g., the index of refraction or shape) of the elements. In certain of such embodiments, substantially all of one or more of theelements106,118, or in further embodiments, substantially all of thesystem100, can be irradiated at about the same time (e.g., substantially simultaneously).
• In some embodiments, only one of theelements106,118 is configured for alteration in situ, or one of theelements106,118 is substantially more alterable in situ than is the other of the elements. In some embodiments, only one of theelements106,118 is susceptible to polymerization under application of radiation, and the other of theelements106,118 is relatively unaffected by application of the radiation. For example, when bothelements106,118 are formed from a unitary piece of material, one of theelements106,118 can be polymerized by an energy source during fabrication of thelens system100 such that the polymerized lens would be relatively unaffected by any polymerizing radiation subsequently applied to thesystem100. In certain of such embodiments, the un-polymerized or adjustable lens is protected from the energy source during fabrication, such as, for example, by a removable energy-reflective or energy-absorbing shield, cover, or coating.
• In other embodiments, theelements106,118 comprise different materials such that each of theelements106,118 is susceptible to polymerization by a different energy source. For example, in some embodiments, theanterior viewing element106 can comprise a material configured to polymerize when exposed to a first band of UV radiation but not a second band of UV radiation, and theposterior viewing element118 can comprise a material configured to polymerize when exposed to the second band of UV radiation but not the first band of UV radiation. Accordingly, in some embodiments, one of theelements106,118 can be selectively irradiated by an energy source substantially without polymerizing the other of theelements118. In further embodiments, theanterior viewing element106 can be substantially transparent to the form of radiation capable of polymerizing theposterior viewing element118, which can facilitate polymerization of theposterior viewing element118. In still other embodiments, only one of theelements106,118 is susceptible to polymerization.
• In some embodiments, theposterior viewing element118 is alterable and theanterior viewing element106 is not alterable, or is substantially less alterable. In certain of such embodiments, theanterior viewing element106 can be polymerized or otherwise treated to at least partially shield theposterior viewing element118 from polymerizing energy, such as UV rays. Theanterior viewing element106 thus can protect theposterior viewing element118 from undesired polymerization prior to desired adjustment by a medical professional. Theposterior viewing element118 can later be altered by exposing the element to an energy source that theanterior viewing element106 is transparent to, such as, for example, a different band of UV radiation or electromagnetic radiation outside the UV range. In other embodiments, theanterior viewing element106 is alterable and theposterior viewing element118 is not alterable, or is substantially less alterable. In some embodiments, an implantedsystem100 having only oneelement106,118 susceptible to polymerization can be relatively easy to adjust because any polymerizing energy applied to thesystem100 will affect only one of theelements106,118.
• In certain embodiments, both of the anterior andposterior viewing elements106,118 are alterable in situ. In some embodiments, bothelements106,118 are adjusted at approximately the same time. For example, in some instances, it may be desirable to determine whether an implantation was successful near the time of the implantation. In various situations, a patient may be evaluated from about 1 to about 3 weeks after implantation, from about 2 to about 3 weeks after implantation, or after the eye has completely or substantially healed. In some instances, thesystem100 may benefit from modifications at the time of a post-implantation examination. Accordingly, one or more of theelements106,118 can be modified, as described above, and both can be polymerized or stabilized to prevent further adjustments. In other instances, thesystem100 may function as desired once the patient has healed, and theelements106,118 can be polymerized or stabilized to prevent subsequent undesirable adjustments.
• In some embodiments, theelements106,118 can be adjusted at separate times. For example, if thesystem100 functions as desired at a post-implantation examination, rather than polymerizing or stabilizing theelements106,118 at that time, one or more of theelements106,118 can instead be modified at one or more subsequent dates to account for vision changes as the patient ages.
• In some instances, one of theelements106,118 can be adjusted during the post-implantation examination, and the other of theelements106,118 can be adjusted at a later time. In some embodiments, the first of theelements106,118 can adjusted to provide proper functioning of thesystem100 near the time of the implantation, and the second of theelements106,118 is adjusted at a later time, which can be from about 1 to 6 months, from about 1 to 12 months, from about 1 to 2 years, from about 1 to 3 years, from about 1 to 5 years, or from about 1 to 10 years after implantation; or no less than about 6 months, no less than about 1 year, no less than about 2 years, or no less than about 5 years after implantation. Accordingly, in various embodiments, thelens system100 can be adjusted at one or more dates to account for changes to the patient's vision as the patient ages. In some embodiments, theanterior viewing element106 is adjusted prior to adjustment of theposterior viewing element118, which can help shield theposterior viewing element118 from undesired radiation, as described above.
• In some embodiments, thelens system100 can be adjusted by curing, polymerizing, or otherwise altering one or more portions of thesystem100 in addition to or instead of theviewing elements106,118. For example, in some embodiments, one or more support components of thelens system100, such as theanterior biasing element108, theposterior biasing element120, thefirst apex112, and thesecond apex116, can comprise any of the materials described above, and further, can be adjusted by irradiation.
• In certain embodiments, polymerization of one or more support components of thelens system100 alters the stiffness, spring constant, and/or shape of the one or more support components. Accordingly, in some embodiments, polymerization can affect the manner in which thesystem100 reacts to forces provided by theciliary muscle60. For example, in some embodiments, polymerization of one or more of the support components stiffens the components such that theviewing elements106,118 are displaced relative to each other by a smaller amount when theciliary muscle60 applies force to thesystem100, as compared with thesystem100 prior to polymerization. In some embodiments, polymerization affects the lens system's response time to changes in forces applied by the eye, e.g. by increasing or decreasing the length of time required for the lens to move from the unaccommodated state to the accommodated state and/or the time required for the lens to move from the accommodated state to the unaccommodated state.
• In some embodiments, alteration of the shape of one or more of the support components can move theviewing elements106,118 closer together or further apart along the optical axis. Accordingly, in some embodiments, the power of thelens system100 can be altered by polymerizing the support components, independent of any changes made to the properties of theviewing elements106,118. In some embodiments, polymerization affects the lens system's range of motion, e.g. by affecting one or both of a separation distance between the anterior and posterior optic when the eye is in an unaccommodated state and a separation distance between the anterior and posterior optic when the eye is in an accommodated state.
• In some embodiments, the support structures are cured during fabrication of thelens system100. In certain of such embodiments, one or more of theviewing elements106,118 are covered during fabrication in any suitable manner, such as those described above, and the remainder of thelens system100 is exposed to an energy source. In some embodiments, the support structures are substantially unaffected by radiation that may subsequently be applied to thelens system100 in situ, which can facilitate alteration of the properties of one or more of theviewing elements106,118.
• Any suitable portion of alens system100 may be pre-treated (e.g., polymerized) to substantially prevent subsequent alteration of that portion in situ. Similarly, any suitable portion of alens system100 may be alterable (e.g., un-polymerized) to allow for subsequent adjustment of thesystem100 in situ.
VIII. Multiple-Piece and Other Embodiments
• FIG. 35 is a schematic view of a two-piece embodiment600 of the lens system. In this embodiment theanterior portion102 and theposterior portion104 are formed as separate pieces which are intended for separate insertion into the capsular bag and subsequent assembly therein. In one embodiment, each of the anterior andposterior portions102,104 is rolled or folded before insertion into the capsular bag. (The insertion procedure is discussed in further detail below.) Theanterior portion102 andposterior portion104 are represented schematically as they may generally comprise any anterior-portion or posterior-portion structure disclosed herein; for example, they may simply comprise thelens system100 shown inFIGS. 3-17, bisected along the line/plane A-A shown inFIG. 4. Theanterior portion102 andposterior portion104 of the two-piece lens system600 will include first andsecond abutments602,604 which are intended to be placed in abutting relation (thus forming the first and second apices of the lens system) during the assembly procedure. The first andsecond abutments602,604 may include engagement members (not shown), such as matching projections and recesses, to facilitate alignment and assembly of the anterior andposterior portions102,104.
• As a further alternative, the anterior andposterior portions102,104 of thelens system600 may be hingedly connected at one of theabutments602,604 and unconnected at the other, to allow sequential (but nonetheless partially assembled) insertion of theportions102,104 into the capsular bag. The individual portions may be separately rolled or folded before insertion. The twoportions102,104 are “swung” together and joined at the unconnected abutment to form the finished lens system after both portions have been inserted and allowed to unfold/unroll as needed.
• FIG. 36 depicts schematically anotherembodiment700 of a two-piece lens system. Thelens system700 is desirably similar to thelens system600 shown inFIG. 35, except for the formation of relatively larger, curledabutments702,704 which are assembled to form theapices112,116 of thesystem700.
• FIGS. 37 and 38 show afurther embodiment800 of the lens system, in which the anterior and posterior biasingelements108,120 comprise integral “band” like members forming, respectively, the first and secondanterior translation members110,114 and the first and secondposterior translation members122,124. The biasingelements108,120 also form reduced-width portions802,804 which meet at the apices of thelens system800 and provide regions of high flexibility to facilitate sufficient accommodative movement. The depicted distendingportion132 includes three pairs of distendingmembers134,136 which have a curved configuration but nonetheless project generally away from the optical axis.
• FIGS. 38A and 38B depict anotherembodiment900 of the lens system, as implanted in thecapsular bag58. The embodiment shown inFIGS. 38A and 38B may be similar to any of the embodiments described above, except that the biasingelements108,120 are dimensioned so that theapices112,116 abut thezonules62 andciliary muscles60 when in the unaccommodated state as seen inFIG. 38A. In addition, thelens system900 is configured such that it will remain in the unaccommodated state in the absence of external forces. Thus, when theciliary muscles60 contract, themuscles60 push theapices112,116 closer together, causing the biasingelements108,120 to bow out and theviewing elements106,118 to separate and attain the accommodated state as shown inFIG. 38B. When theciliary muscles60 relax and reduce/eliminate the force applied to theapices112,116 the biasingelements108,120 move thelens system900 to the unaccommodated state depicted inFIG. 38A.
• FIGS. 38C and 38D depict biasers1000 which may be used bias thelens system100 toward the accommodated or unaccommodated state, depending on the desired operating characteristics of the lens system. It is therefore contemplated that thebiasers1000 may be used with any of the embodiments of thelens system100 disclosed herein. The bias provided by thebiasers1000 may be employed instead of, or in addition to, any bias generated by the biasingelements108,120. In one embodiment (seeFIG. 38C), thebiasers1000 may comprise U-shaped springmembers having apices1002 located adjacent theapices112,116 of thelens system100. In another embodiment (seeFIG. 38D), thebiasers1000 may comprise any suitable longitudinal-compression springs which span theapices112,116 and interconnect the anterior and posterior biasingelements108,120. By appropriately selecting the spring constants and dimensions of the biasers1000 (in the case of U-shaped springs, the apex angle and arm length; in the case of longitudinal-compression springs, their overall length), thebiasers1000 can impart to the lens system100 a bias toward the accommodated or unaccommodated state as desired.
• Thebiasers1000 may be formed from any of the materials disclosed herein as suitable for constructing thelens system100 itself. The material(s) selected for thebiasers1000 may be the same as, or different from, the material(s) which are used to form the remainder of theparticular lens system100 to which thebiasers1000 are connected. The number ofbiasers1000 used in aparticular lens system100 may be equal to or less than the number of apices formed by the biasing elements of thelens system100.
• FIG. 38E depicts a further embodiment of thelens system100 in which theanterior translation members110 and theposterior translation members120 are paired in a number (in the example depicted, four) ofseparate positioners1400 which are radially spaced, preferably equally radially spaced, about the optical axis. In the depicted embodiment, the anterior andposterior translation members110,120 connect directly to the periphery of theviewing elements106,118; however, in other embodiments any of the connection techniques disclosed herein may be employed. As shown, theanterior translation members100 preferably extend anteriorly from the periphery of the anterior viewing element before bending and extending posteriorly toward the apex/apices112. As discussed above, this configuration is advantageous for promotion of fluid flow through an opening formed in the anterior aspect of thecapsular bag58. It has been found that the lens configuration shown inFIG. 38E is well suited for the folding technique shown inFIGS. 40A and 40B below. In additional embodiments, thelens system100 shown inFIG. 38E may incorporate any other suitable features of the other embodiments of thelens system100 disclosed herein, such as but not limited to the distending members and/or retention members detailed above.
• Any of theembodiments100,600,700,800,900 of the lens system can include post-implantation adjustability, such as discussed above in Sections II and VII with respect to thelens system100. Accordingly, in some embodiments, any suitable portion of the any of thelens systems100,600,700,800,900 can comprise a material capable of being adjusted in situ by application of energy thereto.
IX. Implantation Methods
• Various techniques may be employed in implanting the various embodiments of the lens system in the eye of a patient. The physician can first access the anterior aspect of thecapsular bag58 via any appropriate technique. Next, the physician incises the anterior of the bag; this may involve making thecircular opening66 shown inFIGS. 21 and 22, or the physician may make a “dumbbell” shaped incision by forming two small circular incisions or openings and connecting them with a third, straight-line incision. The natural lens is then removed from the capsular bag via any of various known techniques, such as phacoemulsification, cryogenic and/or radiative methods. To inhibit further cell growth, it is desirable to remove or kill all remaining epithelial cells. This can be achieved via cryogenic and/or radiative techniques, antimetabolites, chemical and osmotic agents. It is also possible to administer agents such as P15 to limit cell growth by sequestering the cells.
• In the next step, the physician implants the lens system into the capsular bag. Where the lens system comprises separate anterior and posterior portions, the physician first folds or rolls the posterior portion and places it in the capsular bag through the anterior opening. After allowing the posterior portion to unroll/unfold, the physician adjusts the positioning of the posterior portion until it is within satisfactory limits. Next the physician rolls/folds and implants the anterior portion in a similar manner, and aligns and assembles the anterior portion to the posterior portion as needed, by causing engagement of mating portions, etc. formed on the anterior and posterior portions.
• Where the lens system comprises anterior and posterior portions which are partially assembled or partially integral (see discussion above in the section titled MULTIPLE-PIECE AND OTHER EMBODIMENTS), the physician employs appropriate implantation procedures, subsequently folding/rolling and inserting those portions of the lens system that are separately foldable/rollable. In one embodiment, the physician first rolls/folds one portion of the partially assembled lens system and then inserts that portion. The physician then rolls/folds another portion of the partially assembled lens system and the inserts that portion. This is repeated until the entire system is inside the capsular bag, whereupon the physician completes the assembly of the portions and aligns the lens system as needed. In another embodiment, the physician first rolls/folds all of the separately rollable/foldable portions of the partially assembled lens system and then inserts the rolled/folded system into the capsular bag. Once the lens system is in the capsular bag, the physician completes the assembly of the portions and aligns the lens system as needed.
• It is contemplated that conventional intraocular lens folding devices, injectors, syringes and/or shooters can be used to insert any of the lens systems disclosed herein. A preferred folding/rolling technique is depicted inFIGS. 39A-39B, where thelens system100 is shown first in its normal condition (A). The anterior andposterior viewing elements106,118 are manipulated to place thelens system100 in a low-profile condition (B), in which theviewing elements106,118 are out of axial alignment and are preferably situated so that no portion of theanterior viewing element106 overlaps any portion of theposterior viewing element118, as viewed along the optical axis. In the low-profile position (B), the thickness of thelens system100 is minimized because theviewing elements106,118 are not “stacked” on top of each other, but instead have a side-by-side configuration. From the low-profile condition (B) theviewing elements106,118 and/or other portions of thelens system100 can be folded or rolled generally about the transverse axis, or an axis parallel thereto. Alternatively, the lens system could be folded or rolled about the lateral axis or an axis parallel thereto. Upon folding/rolling, thelens system100 is placed in a standard insertion tool as discussed above and is inserted into the eye.
• When thelens system100 is in the low-profile condition (B), the system may be temporarily held in that condition by the use of dissolvable sutures, or a simple clip which is detachable or manufactured from a dissolvable material. The sutures or clip hold the lens system in the low-profile condition during insertion and for a desired time after insertion. By temporarily holding the lens system in the low-profile condition after insertion, the sutures or clip provide time for fibrin formation on the edges of the lens system which, after the lens system departs from the low-profile condition, may advantageously bind the lens system to the inner surface of the capsular bag.
• The physician next performs any adjustment steps which are facilitated by the particular lens system being implanted. Where the lens system is configured to receive the optic(s) in “open” frame members, the physician first observes/measures/determines the post-implantation shape taken on by the capsular bag and lens system in the accommodated and/or unaccommodated states and select(s) the optics which will provide the proper lens-system performance in light of the observed shape characteristics and/or available information on the patient's optical disorder. The physician then installs the optic(s) in the respective frame member(s); the installation takes place either in the capsular bag itself or upon temporary removal of the needed portion(s) of the lens system from the bag. If any portion is removed, a final installation and assembly is then performed with the optic(s) in place in the frame member(s).
• Where the optic(s) is/are formed from an appropriate photosensitive silicone as discussed above, the physician illuminates the optic(s) (either anterior or posterior or both) with an energy source such as a laser until they attain the needed physical dimensions or refractive index. The physician may perform an intervening step of observing/measuring/determining the post-implantation shape taken on by the capsular bag and lens system in the accommodated and/or unaccommodated states, before determining any needed changes in the physical dimensions or refractive index of the optic(s) in question.
• FIG. 40 depicts a technique which may be employed during lens implantation to create a fluid flow path between the interior of thecapsular bag58 and the region of the eye anterior of thecapsular bag58. The physician forms a number of fluid-flow openings68 in the anterior aspect of thecapsular bag58, at any desired location around theanterior opening66. The fluid-flow openings68 ensure that the desired flow path exists, even if a seal is created between theanterior opening66 and a viewing element of the lens system.
• Where an accommodating lens system is implanted, theopenings68 create a fluid flow path from the region between the viewing elements of the implanted lens system, and the region of the eye anterior of thecapsular bag58. However, the technique is equally useful for use with conventional (non-accommodating) intraocular lenses.
• FIGS. 40A and 40B illustrate another embodiment of a method of folding thelens system100. In this method theanterior viewing element106 is rotated approximately 90 degrees about the optical axis with respect to theposterior viewing element118. This rotation may be accomplished by applying rotational force to the upper edge of thefirst transition member138 and the lower edge of the second transition member140 (or vice versa), as indicated by the dots and arrows inFIG. 40A, while holding theposterior viewing element118 stationary, preferably by gripping or clamping the distendingmembers134,136. Alternatively, rotational force may be applied in a similar manner to a right edge of one of theretention members128,130 and to a left edge of the other of the retention members while holding theposterior viewing element118 stationary. As still further alternatives, theanterior viewing element106 could be held stationary while rotational force is applied to theposterior viewing element118, at an upper edge of one of the distendingmembers134,136 and at a lower edge of the other of the distending members; or both the anterior andposterior viewing elements106,118 could be rotated with respect to each other.
• Preferably, theviewing elements106,118 are spread apart somewhat as the rotation is applied to the lens system so that the translation members and apices are drawn into the space between theviewing elements106,118 in response to the rotational force. Once theanterior viewing element106 has been rotated approximately 90 degrees about the optical axis with respect to theposterior viewing element118, thelens system100 takes on the configuration shown inFIG. 40B, with theretention members128,130 generally radially aligned with the distendingmembers134,136 and the translation members and apices disposed between theviewing elements106,118. This configuration is advantageous for inserting thelens system100 into thecapsular bag58 because it reduces the insertion profile of thelens system100 while storing a large amount of potential energy in the translation members. From the folded configuration the translation members thus exert a high “rebound” force when the lens system has been inserted to thecapsular bag58, causing the lens system to overcome any self-adhesion and spring back to the unfolded configuration shown inFIG. 40A without need for additional manipulation by the physician.
• Once thelens system100 is in the folded configuration shown inFIG. 40B, it may be further folded and/or inserted into thecapsular bag58 by any suitable methods presently known in the art or hereafter developed. For example, as shown inFIG. 40C the folding method may further comprise inserting the foldedlens system100 between theprongs1202,1204 of aclip1200, preferably with theprongs1202,1204 oriented to extend along thetransition members138,140, or along theretention members128,130 and the distendingmembers134,136.
• FIGS. 40D-40F illustrate the use ofjaws1250,1252 of a pliers or forceps to fold thelens system100 as it is held in theclip1200. (FIGS. 40D-40F show an end view of the clip-lens system assembly with thejaws1250,1252 shown in section for clarity.) As shown inFIGS. 40D and 40E, the edges of thejaws1250,1252 are urged against one of the anterior andposterior viewing elements106,118 while thejaws1250,1252 straddle theprong1202 of theclip1200. The resulting three-point load on thelens system1200 causes it to fold in half as shown inFIG. 40E. As thelens system100 approaches the folded configuration shown inFIG. 40F, thejaws1250,1252 slide into a pincer orientation with respect to thelens system100, characterized by contact between theinner faces1254,1256 of thejaws1250,1252 and theanterior viewing element106 orposterior viewing element118. With such a pincer orientation established, the forceps may be used to grip and compress the lens system with inward-directed pressure and theclip1200 can be withdrawn, as shown inFIG. 40F. With thelens system100 thus folded, it can be inserted to thecapsular bag58 by any suitable method presently known in the art or hereafter developed.
• FIG. 40G depicts afolding tool1300 which may be employed to fold thelens system100 as discussed above in connection withFIGS. 40A and 40B. Thetool1300 includes a base1302 withbrackets1304 which hold thelens system100 to thebase1302 by gripping the distendingmembers134,136. Formed within thebase1302 arearcuate guides1306. The tool further comprises arotor1308 which in turn comprises ahorizontal rod1310 and integrally formedvertical rods1312. Thevertical rods1312 engage thearcuate guides1306, both of which have a geometric center on the optical axis of thelens system100. Thevertical rods1312 and thearcuate guides1306 thus coact to allow the horizontal rod to rotate at least 90 degrees about the optical axis of thelens system100. Thehorizontal rod1310 is fixed with respect to theanterior viewing element106 of thelens system100 so as to prevent substantially no relative angular movement between therod1310 and theanterior viewing element106 as the rod1310 (and, in turn, the anterior viewing element106) rotates about the optical axis of thelens system100. This fixed relationship may be established by adhesives and/or projections (not shown) which extend downward from thehorizontal rod1308 and bear against the upper edge of one of thetransition members138,140 and against the lower edge of the other of the transition members as shown inFIG. 40A. As an alternative or as a supplement to this arrangement, the projections may bear against theretention members128,130 in a similar manner as discussed above.
• Thus, when therotor1308 is advanced through its range of angular motion about the optical axis of thelens system100, it forces theanterior viewing element106 to rotate in concert therewith about the optical axis, folding the lens system as discussed above in connection withFIGS. 40A and 40B. It is further contemplated that thefolding tool1300 may comprise the lower half of a package in which the lens system is stored and/or shipped to a customer, to minimize the labor involved in folding the lens system at the point of use. Preferably, the lens system is stored in thetool1300 in the unfolded configuration, so as to avoid undesirable deformation of the lens system.
X. Thin Optic Configurations
• In some circumstances it is advantageous to make one or more of the optics of the lens system relatively thin, in order to facilitate rolling or folding, or to reduce the overall size or mass of the lens system. Discussed below are various optic configurations which facilitate a thinner profile for the optic; any one of these configurations may be employed as well as any suitable combination of two or more of the disclosed configurations.
• One suitable technique is to employ a material having a relatively high index of refraction to construct one or more of the optics. In one embodiment, the optic material has an index of refraction higher than that of silicone. In another embodiment, the material has an index of refraction higher than about 1.43. In further embodiments, the optic material has an index of refraction of about 1.46, 1.49 or 1.55. In still further embodiments, the optic material has an index of refraction of about 1.43 to 1.55. By employing a material with a relatively high index of refraction, the curvature of the optic can be reduced (in other words, the radius/radii of curvature can be increased) thereby reducing the thickness of the optic without loss of focal power.
• A thinner optic can also be facilitated by forming one or more of the surfaces of one or more of the optics as an aspheric surface, while maintaining the focal power of the optic. As shown inFIG. 41, an aspheric,convex optic surface1100 can be formed with the same radius of curvature (as a comparable-power spherical surface) at thevertex1102 of thesurface1100 and a longer radius of curvature (with a common center point) at itsperiphery1104, creating a thinner optic without sacrificing focal power. This contrasts with aspherical optic surface1106, which is thicker at itsvertex1108 than is theaspheric surface1102. In one embodiment, the thickness of the optic is reduced by about 19% at the vertex relative to a comparable-power spherical optic. It is contemplated that thinner, aspheric concave optic surfaces may be used as well. A further advantage of an aspheric optic surface is that it provides better image quality with fewer aberrations, and facilitates a thinner optic, than a comparable spherical surface.
• FIG. 42 depicts a further strategy for providing athinner optic1150. The optic1150 has a curved (spherical or aspheric)optic surface1152 and a flat or planar (or otherwise less curved than a comparable refractive surface)diffractive optic surface1154 in place of a secondcurved surface1156. Thediffractive optic surface1154 can comprise any suitable diffraction grating, including the grooved surface depicted or any other diffractive surface presently known or hereafter developed, including holographic optical elements. By appropriately configuring thediffractive surface1154 as is well known in the art, the optic1150 can be made thinner than one having bothcurved surfaces1152,1154, while providing the same focal power. The use of thediffractive surface1154 not only facilitates a thinner optic, but also reduces aberrations in the resulting image.
• A further alternative for facilitating a thin, easy-to-fold optic is to employ, in place of a biconvex optic of refractive index greater than aqueous humor (i.e., greater than about 1.336), a biconcave optic of refractive index less than about 1.336, which is thinner at the optical axis than the biconvex optic. By constructing the biconcave optic of material having a refractive index less than about 1.336, the biconcave optic can be made to have the same effective focal power, when immersed in aqueous humor, as a given biconvex optic.
• Still another alternative thin optic, shown inFIG. 43, is abiconcave optic1160 of low refractive index (for example, about 1.40 or less or about 1.336 or less) which is clad with first andsecond cladding portions1162,1164 constructed of higher-index material (for example, about 1.43 or greater). Such an optic can be made to have the same effective focal power, when immersed in aqueous humor, as a thicker biconvex optic.
• As a further alternative, one or more of the surfaces of the optics may be formed as a multifocal surface, with spherical and/or aspheric focal regions. A multifocal surface can be made with less curvature than a comparable-power single-focus surface and thus allows the optic to be made thinner. The additional foci provide added power which replaces or exceeds the power that is “lost” when the surface is reduced in curvature. In one embodiment, the multifocal optic is constructed as a concentric-ring, refractive optic. In another embodiment, the multifocal optic is implemented as a diffractive multifocal optic.
• Although the inventions have been disclosed in the context of certain preferred embodiments and examples, it will be understood by those skilled in the art that the present inventions extend beyond the specifically disclosed embodiments to other alternative embodiments and/or uses of the inventions and obvious modifications and equivalents thereof. Thus, it is intended that the scope of the present inventions herein disclosed should not be limited by the particular disclosed embodiments described above, but should be determined only by a fair reading of the claims that follow.

Claims (22)

1. A method of adjusting an intraocular lens after implantation in an eye, the intraocular lens having an anterior optic, a posterior optic, and a support structure configured to move the optics relative to each other along an optical axis between an accommodated state and an unaccommodated state, the method comprising:

non-invasively applying energy to at least a portion of said support structure while the lens is in the eye to alter reaction forces between the support structure and at least one structure of the eye.

2. The method ofclaim 1, wherein said support structure comprises an anterior biasing element, a posterior biasing element, a first apex, and a second apex, and wherein said step of non-invasively applying energy comprises applying energy to at least one of said anterior biasing element, said posterior biasing element, said first apex, or said second apex.

3. The method ofclaim 1, wherein said step of non-invasively applying energy is configured to alter at least one of a stiffness, a spring constant, or a shape of said support structure.

4. The method ofclaim 3, wherein said step of non-invasively applying energy is configured to stiffen said at least portion of said support structure.

5. The method ofclaim 1, wherein said step of non-invasively applying energy is configured to adjust a relative separation of said anterior optic and said posterior optic when said lens is in the accommodated state.

6. A method of adjusting an intraocular lens after implantation in an eye, the intraocular lens having a first optic and a second optic, the method comprising:

non-invasively applying energy to at least a portion of said first optic while the lens is in the eye to adjust a refractive property of said first optic while leaving refractive properties of said second optic substantially unaffected;

non-invasively applying energy to at least a portion of said second optic while the lens is in the eye to adjust a refractive property of said second optic while leaving refractive properties of said first optic substantially unaffected.

7. The method ofclaim 6, wherein said step of non-invasively applying energy to said first optic comprises applying energy from a first energy source and wherein said step of non-invasively applying energy to said second optic comprises applying energy from a second source different from said first source.

8. The method ofclaim 7, wherein said step of applying energy from a first source comprises applying UV radiation in a first band and wherein said step of applying energy from a second source comprises applying UV radiation in a second band.

9. The method ofclaim 7, wherein said step of applying energy from a first energy source to said first optic is performed at a first time, and wherein said step of applying energy from a second energy source to said second optic is performed at a second time after said first time.

10. The method ofclaim 9, wherein said anterior optic is adjusted at said first time and said posterior optic is adjusted at said second time.

11. The method ofclaim 10, wherein said step of adjusting said anterior optic at said first time shields said posterior optic from undesired radiation.

12. The method ofclaim 7 wherein said steps of applying energy from a first source and applying energy from a second source are performed at approximately the same time.

13. A method of adjusting an intraocular lens after implantation in an eye, the intraocular lens having an anterior optic and a posterior optic, the method comprising:

non-invasively applying energy to at least a portion of one of said anterior optic and said posterior optic while the lens is in the eye to alter a refractive property of said one of said optics while leaving refractive properties of a remaining one of said optics substantially unaffected.

14. The method ofclaim 13, the method further comprising subsequently applying energy to a remaining portion of said one of said optics to thereby prevent subsequent alteration of said remaining portion.

15. The method ofclaim 13, the method further comprising non-invasively applying energy to said portion of said one of said optics to prevent subsequent alteration of said one of said optics.

16. The method ofclaim 13, wherein said step of non-invasively applying energy comprises non-invasively applying energy to at least a portion of said posterior optic to thereby alter a refractive property of said posterior optic and wherein said anterior optic is configured such that refractive properties of said anterior optic are substantially unaffected by said applied energy.

17. The method ofclaim 16, further comprising at least partially shielding said posterior optic from UV rays with said anterior optic to thereby prevent undesired polymerization of said posterior optic prior to desired adjustment by a medical professional.

18. The method ofclaim 17, wherein said step of non-invasively applying energy comprises exposing said posterior optic to an energy source to which said anterior optic is substantially transparent.

19. The method ofclaim 13, wherein said step of non-invasively applying energy comprises applying energy that is substantially single-wavelength.

20. The method ofclaim 13, wherein said step of non-invasively applying energy comprises applying energy having a band of wavelengths.

21. The method ofclaim 13, wherein said step of non-invasively applying energy comprises applying one or more of electron beam, microwave, radio frequency, or acoustic energy.

22. The method ofclaim 13, wherein said step of non-invasively applying energy changes a shape of said one of said optics.

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