US20050267576A1 - Accommodating intraocular lens having T-shaped haptics - Google Patents

Abstract

An accommodating intraocular lens having anteriorly and posteriorly movable extended portions, such as T-shaped haptics, extending from a central optic to be implanted within a natural capsular bag of a human eye with the extended portions positioned between an anterior capsular rim and a posterior capsule of the bag, whereby during a post-operative healing period, fibrosis occurs about the extended portions to fixate the lens in the bag in a manner such that subsequent natural contraction and relaxation of the ciliary muscle moves the optic to provide vision accommodation of increased accommodation amplitude and diopters of accommodation.

Description

RELATED APPLICATIONS
• This application is a continuation of co-pending application Ser. No. 10/454,280 filed on Jun. 3, 2003 which is a continuation of co-pending application Ser. No. 10/057,691 filed Jan. 24, 2002, now U.S. Pat. No. 6,638,306, which is a divisional application of application Ser. No. 08/858,978 filed May 20, 1997, now U.S. Pat. No. 6,387,126 issued May 14, 2002, which is a continuation-in-part of application Ser. No. 08/388,735 filed Feb. 15, 1995, now abandoned.
• Reference is made to co-pending application Ser. No. 08/640,118, which is a continuation, with intermediate continuation applications of my U.S. Pat. No. 5,476,514. Reference is also made to U.S. Pat. No. 5,496,366.
BACKGROUND OF THE INVENTION
• This invention relates generally to intraocular lenses to be implanted within a natural capsular bag in the human eye formed by evacuation of the crystalline matrix from the natural lens of the eye through a anterior capsulotomy in the lens. The invention relates more particularly to novel accommodating intraocular lenses of this kind having a number of improved features including, most importantly, increased amplitude or diopters of accommodation.
• The human eye has an anterior chamber between the cornea and iris, a posterior chamber behind the iris containing a crystalline lens, a vitreous chamber behind the lens containing vitreous humor, and a retina at the rear of the vitreous chamber. The crystalline lens of a normal human eye has a lens capsule attached about its periphery to the ciliary muscle of the eye by zonules and containing a crystalline lens matrix. This lens capsule has elastic optically clear anterior and posterior membrane-like walls commonly referred to by ophthalmologists as anterior and posterior capsules, respectively. Between the iris and the ciliary muscle is an annular crevice-like space called the ciliary sulcus.
• The human eye possesses natural accommodation capability. Natural accommodation capability involves relaxation and constraction of the ciliary muscle of the eye by the brain to provide the eye with near and distant vision. This ciliary muscle action is automatic and shapes the natural crystalline lens to the appropriate optical configuration for focusing on the retina the light rays entering the eye from the scene being viewed.
• The human eye is subject to a variety of disorders which degrade or totally destroy the ability of the eye to function properly. One of the more common of these disorders involves progressive clouding of the natural crystalline lens matrix resulting in the formation of what is referred to as a cataract. It is now common practice to cure a cataract by surgically removing the cataractous human crystalline lens and implanting an artificial intraocular lens in the eye to replace the natural lens. The prior art is replete with a vast assortment of intraocular lenses for this purpose.
• Intraocular lenses differ widely in their physical appearance and arrangement. This invention is concerned with intraocular lenses of the kind having a central optical region or optic and haptics which extend outward from the optic and engage the interior of the eye in such a way as to support the optic on the axis of the eye.
• Up until the late 1980s, cataracts were surgically removed by either intracapsular extraction involving removal of the entire human lens including both its outer lens capsule and its inner crystalline lens matrix, or by extracapsular extraction involving removal of the anterior capsule of the lens and the inner crystalline lens matrix but leaving intact the posterior capsule of the lens. Such intracapsular and extracapsular procedures are prone to certain post-operative complications which introduce undesirable risks into their utilization. Among the most serious of these complications are opacification of the posterior capsule following extracapsular lens extraction, intraocular lens decentration, cystoid macular edema, retinal detachment, and astigmatism.
• An improved surgical procedure called anterior capsulotomy was developed to alleviate the above and other post-operative complications and risks involved in intracapsular and extracapsular cataract extraction. Simply stated, anterior capsulotomy involves forming an opening in the anterior capsule of the natural lens, leaving intact within the eye a capsular bag having an elastic posterior capsule, an anterior capsular remnant or rim about the anterior capsule opening, and an annular crevice, referred to herein as a cul-de-sac, between the anterior capsule remnant and the outer circumference of the posterior capsule. This capsular bag remains attached about its periphery to the surrounding ciliary muscle of the eye by the zonules of the eye. The cataractous natural lens matrix is extracted from the capsular bag through the anterior capsule opening by phacoemulsification and aspiration or in some other way after which an intraocular lens is implanted within the bag through the opening.
• A relatively recent and improved form of anterior capsulotomy known as capsulorhexis is essentially a continuous tear circular or round capsulotomy. A capsulorhexis is performed by tearing the anterior capsule of the natural lens capsule along a generally circular tear line substantially coaxial with the lens axis and removing the generally circular portion of the anterior capsule surrounded by the tear line. A continuous tear circular capsulotomy or capsulorhexis, if performed properly, provides a generally circular opening through the anterior capsule of the natural lens capsule substantially coaxial with the axis of the eye and surrounded circumferentially by a continuous annular remnant or rim of the anterior capsule having a relatively smooth and continuous inner edge bounding the opening. When performing a continuous tear circular capsulorhexis, however, the anterior rim may sometimes be accidentally torn, nicked, or otherwise ruptured, which renders the rim prone to tearing when the rim is stressed, as it is during fibrosis as discussed below.
• Another anterior capsulotomy procedure, referred to as an envelope capsulotomy, involves cutting a horizontal incision in the anterior capsule of the natural lens capsule, then cutting two vertical incisions in the anterior capsule intersecting and rising from the horizontal incision, and finally tearing the anterior capsule along a tear line having an upper upwardly arching portion which starts at the upper extremity of the vertical incision and continues in a downward vertical portion parallel to the vertical incision which extends downwardly and then across the second vertical incision. This procedure produces a generally archway-shaped anterior capsule opening centered on the axis of the eye. The opening is bounded at its bottom by the horizontal incision, at one vertical side by the vertical incision, at its opposite vertical side by the second vertical incision of the anterior capsule, and at its upper side by the upper arching portion of the capsule tear. The vertical incision and the adjacent end of the horizontal incision form a flexible flap at one side of the opening. The vertical tear edge and the adjacent end of the horizontal incision form a second flap at the opposite side of the opening.
• A third capsulotomy procedure, referred to as a beer can or can opener capsulotomy, involves piercing the anterior capsule of the natural lens at a multiplicity of positions along a circular line substantially coaxial with the axis of the eye and then removing the generally circular portion of the capsule circumferentially surrounded by the line. This procedure produces a generally circular anterior capsule opening substantially coaxial with the axis of the eye and bounded circumferentially by an annular remnant or rim of the anterior capsule. The inner edge of this rim has a multiplicity of scallops formed by the edges of the pierced holes in the anterior capsule which render the annular remnant or rim prone to tearing radially when the rim is stressed, as it is during fibrosis as discussed below.
• Intraocular lenses also differ with respect to their accommodation capability, and their placement in the eye. Accommodation is the ability of an intraocular lens to accommodate, that is, to focus the eye for near and distant vision. Certain patents describe alleged accommodating intraocular lenses. Other patents describe non-accommodating intraocular lenses. Most non-accommodating lenses have single focus optics which focus the eye at a certain fixed distance only and require the wearing of eye glasses to change the focus. Other non-accommodating lenses have bifocal optics which image both near and distant objects on the retina of the eye. The brain selects the appropriate image and suppresses the other image. so that a bifocal intraocular lens provides both near vision and distant vision sight without eyeglasses. Bifocal intraocular lenses, however, suffer from the disadvantage that each bifocal image represents only about 40% of the available light, and a remaining 20% of the light is lost in scatter.
• There are four possible placements of an intraocular lens within the eye. These are (a) in the anterior chamber, (b) in the posterior chamber, (c) in the capsular bag, and (d) in the vitreous chamber. The intraocular lenses disclosed herein are for placement in the capsular bag.
SUMMARY OF THE INVENTION
• This invention provides an improved accommodating intraocular lens to be implanted within a capsular bag of a human eye which remains intact within the eye after removal of the crystalline lens matrix from the natural lens of the eye through an anterior capsule opening in the natural lens. This anterior opening is created by performing an anterior capsulotomy, preferably an anterior capsulorhexis, on the natural lens and is circumferentially surrounded by an anterior capsular rim which is the remnant of the anterior capsule of the natural lens. An improved accommodating intraocular lens according to the invention includes a central optic having normally anterior and posterior sides and extended portions spaced circumferentially about and extending generally radially out from the edge of the optic. These extended portions have inner ends joined to the optic and opposite outer ends movable anteriorly and posteriorly relative to the optic. To this end, the extended portions are either pivotally or flexibly hinged at their inner ends to the optic or are resiliently bendable throughout their length. In this disclosure, the terms “flex”, “flexing”, “flexible”, and the like are used in a broad sense to cover both flexibly hinged and resiliently bendable extended portions. The terms “hinge”, “hinged”, “hinging”, and the like are used in a broad sense to cover both pivotally and flexibly hinged extended portions.
• The lens is surgically implanted within the evacuated capsular bag of a patient's eye through the anterior capsule opening in the bag and in a position wherein the lens optic is aligned with the opening, and the outer ends of the lens extended portions are situated within the outer perimeter or cul-de-sac of the bag. The lens has a radial dimension from the outer end of each extended portion to the axis of the lens optic such that when the lens is implanted within the capsular bag, the outer ends of the extended portions engage the inner perimetrical wall of the bag without stretching the bag.
• After surgical implantation of the accommodating intraocular lens in the capsular bag of the eye, active endodermal cells on the posterior side of the anterior capsule rim of the bag cause fusion of the rim to the elastic posterior capsule of the bag by fibrosis. This fibrosis occurs about the lens extended portions in such a way that these extended portions are effectively “shrink-wrapped” by the fibrous tissue in such a way as to form radial pockets in the fibrous tissue which contain the extended portions with their outer ends positioned within the outer cul-de-sac of the capsular bag. The lens is thereby fixated within the capsular bag with the lens optic aligned with the anterior capsule opening in the bag. The anterior capsule rim shrinks during fibrosis, and this shrinkage combined with shrink-wrapping of the extended portions causes some radial compression of the lens in a manner which tends to move the lens optic relative to the outer ends of the extended portions in one direction or the other along the axis of the optic. The fibrosed, leather-like anterior capsule rim prevents anterior movement of the optic and urges the optic rearwardly during fibrosis. Accordingly, fibrosis induced movement of the optic occurs posteriorly to a distant vision position in which either or both the optic and the inner ends of the extended portions press rearwardly against the elastic posterior capsule of the capsular bag and stretch this posterior capsule rearwardly.
• During surgery, the ciliary muscle of the eye is paralyzed with a ciliary muscle relaxant, i.e. a cycloplegic, to place the muscle in its relaxed state. Following surgery, a ciliary muscle relaxant is periodically introduced into the eye throughout a post-operative fibrosis and healing period (from two to three weeks) to maintain the ciliary muscle in its relaxed state until fibrosis is complete. This drug-induced relaxation of the ciliary muscle prevents contraction of the ciliary muscle and immobilizes the capsular bag during fibrosis. By this means, the lens optic is fixed during fibrosis in its distant vision position within the eye relative to the retina wherein the lens presses rearwardly against and thereby posteriorly stretches the elastic posterior capsule of the capsular bag. If the ciliary muscle was not thus maintained in its relaxed state until the completion of fibrosis, the ciliary muscle would undergo essentially normal brain-induced vision accommodation contraction and relaxation during fibrosis. This ciliary muscle action during fibrosis would result in improper formation of the pockets in the fibrosis tissue which contain the extended portions of the lens. Moreover, ciliary muscle contraction during fibrosis would compress the capsular bag and thereby the lens radially in such a way as to very likely dislocate or decenter the lens from its proper position in the bag or fix the optic in the near vision position.
• When the cycloplegic effect of the ciliary muscle relaxant wears off after the completion of fibrosis, the ciliary muscle again becomes free to undergo normal brain-induced contraction and relaxation. Normal brain-induced contraction of the muscle then compresses the lens radially, relaxes the anterior capsule rim, and increases vitreous pressure in the vitreous chamber of the eye. This normal contraction of the ciliary muscle effects anterior accommodation movement of the lens optic for near vision by the combined action of the increased vitreous pressure, anterior capsule rim relaxation, and the anterior bias of the stretched posterior capsule. Similarly, brain-induced relaxation of the ciliary muscle reduces vitreous pressure, relieves radial compression of the lens, and stretches the anterior capsule rim to effect posterior movement of the lens optic for distant vision.
• Normal brain-induced relaxation and contraction of the ciliary muscle after the completion of fibrosis thus causes anterior and posterior accommodation movement of the lens optic between near and distant vision positions relative to the retina. During this accommodation movement of the optic, the lens extended portions undergo endwise movement within their pockets in the fibrous tissue.
• The described lens embodiments of the invention conform to one of the following basic lens configurations: (a) a lens configuration, hereafter referred to as a posteriorly biased lens configuration, in which the hinges of hinged extended portions and the inner ends of resiliently bendable extended portions are located posteriorly of or approximately in a plane (tip plane) normal to the optic axis and containing the outer tips of the extended portions when the lens occupies its posterior distant vision position against the posterior capsule of the eye, and (b) a lens configuration, hereafter referred to as an anteriorly biased lens configuration, in which the hinges of hinged extended portions and the inner ends of resiliently bendable extended portions are located forwardly of the tip plane when the lens occupies its posterior distant vision position against the posterior capsule of the eye. Radial compression of a posteriorly biased lens by constriction of the ciliary muscle during accommodation initially urges the lens optic posteriorly against the more dominant anterior forces of the stretched posterior capsule and the increasing vitreous pressure which combine to move the optic forwardly in accommodation against the rearward bias of the compressing lens until the hinges of hinged extended portions or the inner ends of resiliently bendable extended portions move forwardly of the tip plane. Continued radial compression of the lens by ciliary muscle constriction then aids anterior accommodation movement of the lens. Radial compression of an anteriorly biased lens by constriction of the ciliary muscle urges the lens optic anteriorly and thus aids the dominant anterior forces of the stretched posterior capsule and the increasing vitreous pressure throughout the range of lens accommodation.
• According to another important aspect of this invention, the extended portions of a presently preferred lens embodiment are generally T-shaped haptics each including a haptic plate and a pair of relatively slender resiliently flexible fixation fingers at the outer end of the haptic plate. In their normal unstressed state, the two fixation fingers at the outer end of each haptic plate extend laterally outward from opposite edges of the respective haptic plate in the plane of the plate and substantially flush with the radially outer end edge of the plate to form the horizontal “crossbar” of the haptic T-shape. The radially outer end edges of the haptic plates are circularly curved about the central axis of the lens optic to substantially equal radii closely approximating the radius of the interior perimeter of the capsular bag when the ciliary muscle of the eye is relaxed. During implantation of the lens in the bag, the inner perimetrical wall of the bag deflects the haptic fingers generally radially inward from their normal unstressed positions to arcuate bent configurations in which the radially outer edges of the fingers and the curved outer end edges of the respective haptic plates conform approximately to a common circular curvature closely approximating the curvature of the inner perimetrical wall of the bag. The outer T-ends of the haptics then press lightly against the perimetrical bag wall and are fixated within the bag perimeter during fibrosis to accurately center the implanted lens in the bag with the lens optic aligned with the anterior capsule opening in the bag.
• The haptic plates of certain described lens embodiments are narrower in width than the optic diameter and are tapered so as to narrow in width toward their outer ends. These relatively narrow plates of the haptics flex or pivot relatively easily to aid the accommodating action of the lens and form haptic pockets of maximum length in the fibrous tissue between the haptic fingers and the optic which maximize the accommodation movement of the lens optic. The tapered haptics, being wider adjacent to the optic, can slide radially in the capsular bag pockets during contraction of the of the ciliary muscle to enable forward movement of the optic for vision accommodation.
• In some described lens embodiments of the invention, the lens optic and extended portions are molded or otherwise fabricated as an integral one piece lens structure in which the inner ends of the extended portions are integrally joined to the optic, and the extended portions are either resiliently flexible at each point throughout their length or have flexible hinges at their inner ends adjacent the optic at which the extended portions are hingable anteriorly and posteriorly relative to the optic. In other described lens embodiments, the optic and extended portions are formed separately and have mating hinge portions which interengage to pivotally join the optic and extended portions. In some of these described embodiments, the extended portions are T-shaped haptics formed by molding or otherwise forming the flexible haptic fingers integrally with the haptic plates proper. In other described inventive embodiments, the extended portions are T-shaped haptics having T-shaped reinforcing inserts or inlays which both reinforce the haptic plates and provide the haptics with their T-shapes. Still other described embodiments have reinforcing inserts which reinforce the haptics, provide the haptics with their T-shapes, and/or provide the haptics and optic with mating pivotal hinge portions for pivotally connecting the haptics to the optic.
• According to another important aspect, the invention provides an accommodating intraocular lens having haptics which are thickened so as to increase in thickness toward their inner ends and have contoured, convexly rounded posterior surfaces adjacent their inner ends. These contoured haptic surfaces and the posterior surface of the lens optic are disposed relative to one another in the axial direction of the optic axis in such a way that when the intraocular lens occupies its posterior distant vision in the eye with the ciliary muscle relaxed, the lens contacts the posterior capsule of the eye in one of the following ways: (a) only the posterior surfaces of the lens haptics contact the posterior capsule, (b) only the posterior surface of the lens optic contacts the posterior capsule, (c) the posterior surfaces of both the haptics and optic contact the posterior capsule. In lens configurations (a) and (c) above, the contoured posterior surfaces of the haptics slide along the posterior capsule during constriction of the ciliary muscle to increase and enhance anterior accommodating movement of the optic. In lens configuration (a), the posterior surface of the optic is spaced from the posterior capsule to permit laser capsulotomy of the posterior capsule without laser damage to the lens optic in the event that the posterior capsule becomes cloudy after implantation of the lens.
• A primary and perhaps the most important aspect of the invention is concerned with increasing the accommodation amplitude of the lens, that is the distance the lens optic moves along the axis of the eye during contraction of the ciliary muscle from its relaxed distant vision state to its contracted near vision state. This amplitude is commonly measured and stated in units which are referred to as diopters of accommodation. The maximum accommodation amplitude or diopters of accommodation which the eye will accommodate varies from patient to patient. Some patient's eyes, for example, will accomodate on the order of 3.5 diopters of accommodation. Other patient's eyes will accommodate a maximum of only about 1.75 diopters of accommodation. Accordingly, it is desireable that an accommodating intraocular lens according to this invention be capable of at least 3.5 diopters of accommodation so that it can be used on a patient who can accommodate such a lens and thereby eliminate the need for the patient to wear glasses for near vision.
• According to this latter aspect of the invention, the diopters of accommodation of the present accommodating intraocular lens are increased in either or both of the following ways: (a) moving the hinges of lens extended portions or haptics anteriorly relative to the posterior capsule engaging surface(s) of the lens optic in the manner explained earlier so as to increase the portion of ciliary muscle contraction over which the resulting muscular compression of the lens produces an anterior accomodating force on the lens optic, (b) increasing the optical power of the lens, and thereby the amount of vision accommodation produced by any given accommodation movement of the optic, by shaping the optic so that most of its optical power is at the posterior side of the optic and the posterior surface of the optic is steeply curved to retain the optic sharply focused on the retina.
• Presently preferred accommodating intraocular lenses of the invention are described. These preferred lenses are anteriorly biassed lens including generally T-shaped, flexibly hinged haptics and optics whose posterior portions provide most of the opitcal power of the optics. These optics cooperate with the anteriorly biassed configurations of the lenses to increase accommodation amplitude or diopters of accommodation by both of the ways mentioned above.
BRIEF DESCRIPTION OF THE DRAWINGS
• FIG. 1 is an anterior face view of an improved posteriorly biased accommodating intraocular lens according to the invention having hinged extended portions in the form of T-shaped haptics and showing the lens in its normal unstressed state;
• FIG. 2 is an edge view of the improved lens inFIG. 1 looking in the direction of thearrow2 inFIG. 1 and showing the hinging action of the lens haptics in broken lines;
• FIG. 3 is a section taken through a human eye having the improved accommodating intraocular lens ofFIGS. 1 and 2 implanted within a natural capsular bag in the eye;
• FIG. 4 is an enlarged view taken on line4-4 inFIG. 3 with portions broken away for clarity;
• FIG. 5 is an enlarged fragmentary section similar to the anterior portion ofFIG. 3 illustrating the initial placement of the lens in the eye;
• FIGS. 6-8 are sections similar toFIG. 5 illustrating the normal vision-accommodating action of the accommodating lens;
• FIG. 9 is an anterior face view of a modified accommodating intraocular lens according to the invention having extended portions in the form of resiliently bendable T-shaped haptics;
• FIG. 10 is an edge view of the lens inFIG. 9 illustrating the flexibility of the lens haptics;
• FIG. 11 is an anterior face view of a modified accommodating intraocular lens according to the invention including three extended portions in the form of hinged T-shaped haptics;
• FIG. 12 is an enlarged partial section, similar to the anterior portion ofFIG. 3, illustrating a modified posteriorly biased accommodating intraocular lens of the invention having thickened, curved haptics;
• FIG. 13 is a fragmentary sectional view similar to a portion ofFIG. 12, showing the lens ofFIG. 12 after fibrosis of haptic end portions;
• FIG. 14 is a view similar to that ofFIG. 11 but showing the lens positioned for mid-range vision;
• FIG. 15 is a view similar to those ofFIGS. 13 and 14 but showing the lens positioned to accommodate near vision;
• FIG. 16 is a view similar toFIG. 3 but showing an anteriorly biased accommodating intraocular lens of the invention in its posterior distant vision position within the eye after completion of fibrosis following surgery;
• FIG. 17 is an enlargement of the area encircled by the arrow17-17 inFIG. 16;
• FIG. 18 is a further enlarged view of the intraocular lens and natural capsular bag ofFIG. 17 showing incoming light rays focused on the retina of the eye;
• FIGS. 19 and 20 are views similar to the anterior portion ofFIG. 18 but illustrating two modified anteriorly biased accommodating intraocular lenses according to the invention in their posterior distant vision positions within the capsular bag of the eye;
• FIG. 21 is an exploded fragmentary perspective view of a modified accommodating intraocular lens according to the invention having pivotally hinged haptics;
• FIG. 22 is a view similar toFIG. 21 but showing a modified haptic hinge arrangement including reinforcing hinge inserts or inlays;
• FIG. 23 is a view similar toFIG. 22 showing a modified hinge arrangement;
• FIG. 24 is a perspective view of a further modified accommodating intraocular lens according to the invention having hinged extended portions in the form of reinforced plate haptics;
• FIG. 25 is a view similar toFIG. 18 but showing a modified, presently preferred anteriorly biased accommodating intraocular lens according to the invention which provides increased accommodation amplitude and increased diopters of accommodation;
• FIG. 26 is an anterior face view of the lens inFIG. 25;
• FIG. 27 is an edge view of the lens inFIG. 25; and
• FIG. 28 is a view similar to the anterior portion ofFIG. 25 showing the preferred intraocular lens in solid lines in a mid-range position of accommodation, in phantom lines in its posterior distant vision position of accommodation, and in dashed lines in its anterior near vision position of accommodation.
DESCRIPTION OF THE PREFERRED EMBODIMENT
• Turning now to these drawings, and first toFIG. 3, there is illustrated ahuman eye10 whose natural crystalline lens matrix has been removed from the natural lens capsule of the eye through an anterior opening in the capsule formed by an anterior capsulotomy, in this case a continuous tear circular capsulotomy, or capsulorhexis. As noted earlier, this natural lens matrix, which is normally optically clear, often becomes cloudy and forms a cataract which is cured by removing the matrix and replacing it with an artificial intraocular lens.
• As mentioned earlier, continuous tear circular capsulotomy, or capsulorhexis, involves tearing the anterior capsule along a generally circular tear line in such a way as to form a relatively smooth-edged circular opening in the center of the anterior capsule. The cataract is removed from the natural lens capsule through this opening. After completion of this surgical procedure, the eye includes an optically clearanterior cornea12, anopaque sclera14 on the inner side of which is theretina16 of the eye, aniris18, acapsular bag20 behind the iris, and avitreous cavity21 behind the capsular bag filled with the gel-like vitreous humor. Thecapsular bag20 is the structure of the natural lens of the eye which remains intact within the eye after the continuous tear circular tear capsulorhexis has been performed and the natural lens matrix has been removed from the natural lens.
• Thecapsular bag20 includes an annular anterior capsular remnant orrim22 and anelastic posterior capsule24 which are joined along the perimeter of the bag to form an annular crevice-like cul-de-sac25 (FIG. 5) between rim and posterior capsule. Thecapsular rim22 is the remnant of the anterior capsule of the natural lens which remains after capsulorhexis has been performed on the natural lens. This rim circumferentially surrounds a central, generally round anterior opening26 (capsulotomy) in the capsular bag through which the natural lens matrix was previously removed from the natural lens. Thecapsular hag20 is secured about its perimeter to theciliary muscle28 of the eye byzonules30.
• Natural accommodation in a normal human eye having a normal human crystalline lens involves automatic contraction or constriction and relaxation of the ciliary muscle of the eye by the brain in response to looking at objects at different distances. Ciliary muscle relaxation, which is the normal state of the muscle, shapes the human crystalline lens for distant vision. Ciliary muscle contraction shapes the human crystalline lens for near vision. The brain-induced change from distant vision to near vision is referred to as accommodation.
• Implanted within thecapsular bag20 of theeye10 is an accommodatingintraocular lens32 according to this invention which replaces and performs the accommodation function of the removed human crystalline lens. The accommodating intraocular lens may be utilized to replace either a natural lens which is virtually totally defective, such as a cataractous natural lens, or a natural lens that provides satisfactory vision at one distance without the wearing of glasses but provides satisfactory vision at another distance only when glasses are worn. For example, the accommodating intraocular lens of the invention can be utilized to correct refractive errors and restore accommodation for persons in their mid-40s who require reading glasses or bifocals for near vision.
• Intraocular lens32 comprises a unitary body which may be formed of relatively hard material, relatively soft flexible semi-rigid material, or a combination of both hard and soft materials. Examples of relatively hard materials which are suitable for the lens body are methyl methacrylate, polysulfones, and other relatively hard biologically inert optical materials. Examples of suitable relatively soft materials for the lens body are silicone, hydrogels, thermolabile materials, and other flexible semi-rigid biologically inert optical materials.
• Thelens32 includes acentral optic34 and T-shaped extended portions or plate haptics36 extending from diametrically opposite edges of the optic. These haptics include haptic members orplates36aproper having inner ends joined to the optic and opposite outer free ends andlateral fixation fingers36bat their outer ends. Thehaptic plates36aare longitudinally tapered so as to narrow in width toward their outer ends and may have a width throughout their length less than the diameter of the optic34. Thehaptics36 are movable anteriorly and posteriorly relative to the optic34, that is to say the outer ends of the haptics are movable anteriorly and posteriorly relative to the optic. The preferred lens embodiment illustrated is constructed of a resilient semi-rigid material and hasflexible hinges38 which join the inner ends of thehaptic plates36ato the optic. The haptics are relatively rigid and are flexible about the hinges anteriorly and posteriorly relative to the optic as shown inFIG. 2. These hinges are formed bygrooves40 which enter either the anterior or posterior sides and extend across the inner ends of thehaptic plates36a. Thehaptics36 are flexible about thehinges38 in the anterior and posterior directions of the optic. The lens has a relatively flat unstressed configuration, illustrated inFIG. 3, wherein thehaptics36 and theirhinges38 are disposed in a common plane transverse to the optic axis of the optic34. Deformation of the lens from this normal unstressed configuration by anterior or posterior deflection of the haptics about their hinges creates in the hinges elastic strain energy forces which urge the lens to its normal unstressed configuration. The outer end edges41 of thehaptic plates36aare preferably circularly curved to equal radii about the optic axis of the optic34, as shown inFIG. 1. In their normal unstressed state shown in solid lines inFIG. 1, thefingers36bof each plate haptic36 extend laterally out from opposite longitudinal edges of the respectivehaptic plate36ain the plane of the plate and substantially flush with theouter end edge41 of the plate. When unstressed, thefingers36bare preferably bowed with a slight radially inward curvature, as shown in solid lines inFIG. 1. As shown in broken lines inFIG. 1, thefingers36bare laterally resiliently flexible radially of thehaptic plates36ato their broken line positions ofFIG. 1 in which the radially outer edges of the fingers and the end edges41 of thehaptic plates36aconform substantially to a common circle centered on the axis of the optic34.
• The accommodatingintraocular lens32 is implanted within thecapsular bag20 of theeye10 in the position shown inFIGS. 4 and 5. When implanting the lens in the eye, theciliary muscle28 of the eye is paralyzed in its relaxed state, shown inFIG. 5, in which this muscle stretches thecapsular bag20 to its maximum diameter. The lens is inserted into the bag through theanterior capsule opening26 and is sized in length, endwise of thehaptics36, for placement of the lens in the position shown inFIGS. 4 and 5. In this position, thelens optic34 is aligned withanterior opening26 in the bag, as shown inFIG. 4. The posterior side of the lens faces theelastic posterior capsule24 of the capsular bag, and the posterior side of thelens optic34 is disposed in close proximity to or contacts the posterior capsule. The radially outer T-ends of thelens haptics36 are positioned within the cul-de-sac25 of the capsular bag with the outer end edges41 of thehaptic plates36aand thehaptic fingers36bin close proximity to or seating lightly against the capsular bag cul-de-sac wall. This cul-de-sac wall deflects the haptic fingers inwardly to the positions shown in broken lines inFIG. 4 (which approximate the broken line finger positions shown inFIG. 1). In these deflected positions, the end edges41 of the haptic plates and thehaptic fingers36bconform closely to the curvature of the cul-de-sac wall to accurately center the lens in the capsular bag. The lens is thus sized and shaped so that when theciliary muscle28 is paralyzed in its relaxed state, the lens fits in thecapsular bag20 with a sufficiently close fit to accurately align thelens optic34 with the anterior capsule opening26 in the bag without significantly deforming the bag.
• The actual dimensions of an intraocular lens according to this invention will be determined by each patient's ocular dimensions. Following are the dimensions of a typical accommodating intraocular lens according to the invention:

  Diameter of optic 3	44.50 mm
  Inner end width ofhaptic plates 36a	1.5 mm
  Outer end width ofhaptic plates 36a	1.3 mm
  Outer end radius ofhaptic plates 36a	5.25 mm
  Haptic finger thickness	0.12 mm
  Distance between unstressed haptic finger tips	4.5 mm
  Longitudinal distance between unstressed haptic finger tips	11.5 mm

• During a post-operative fibrosis and healing period on the order of two to three weeks following surgical implantation of thelens32 in thecapsular bag20, epithelial cells under the anterior capsular rim22 of the bag cause fusion of the rim to theposterior capsule24 by fibrosis. This fibrosis occurs around the lens haptics36 in such a way that the haptics are “shrink-wrapped” by thecapsular bag20, and the haptics form pockets42 in thefibrosed material43. These pockets cooperate with the lens haptics to position and center the lens in the eye. In order to insure proper formation of thehaptic pockets42 and prevent dislocation of the lens by ciliary muscle contraction during fibrosis, sufficient time must be allowed for fibrosis to occur to completion without contraction of theciliary muscle28 from its relaxed state ofFIG. 5. This is accomplished by introducing a ciliary muscle relaxant (cycloplegic) into the eye before surgery to dilate the pupil and paralyze the ciliary muscle in its relaxed state and having the patient periodically administer cycloplegic drops into the eye during a post-operative period of sufficient duration (two to five weeks) to permit fibrosis to proceed to completion without contraction of the ciliary muscle. The cycloplegic maintains theciliary muscle28 in its relaxed state in which thecapsular bag20 is stretched to its maximum diameter (FIG. 5) and immobilized, and the anterior capsular rim22 is stretched to a taut trampoline-like condition or position. The rim fibroses from this taut condition. The cycloplegic passes through the cornea of the eye into the fluid within the eye and then enters the ciliary muscle from this fluid. While other cycloplegics may be used, atropine is the preferred cycloplegic because of its prolonged paralyzing effect compared to other cycloplegics. One drop of atropine, for example, may last for two weeks. However, to be on the safe side, patients may be advised to place one drop of atropine in the eye every day during the fibrosis period.
• Thecapsular rim22 shrinks during fibrosis and thereby shrinks thecapsular bag20 slightly in its radial direction. This shrinkage combines with shrink wrapping of thelens haptics36 produces some opposing endwise compression of the lens which tends to buckle or flex the lens at itshinges38 and thereby move thelens optic34 along the axis of the eye. Unless restrained, this flexing of the lens might occur either forwardly or rearwardly. The taut anteriorcapsular rim22 pushes rearwardly against and thereby prevents forward flexing of the lens. This fibrosis-induced compression of the lens is not sufficient to interfere with proper formation of the haptic pockets in the fibrosed tissue or cause dislocation of the lens. Accordingly, endwise compression of the lens by fibrosis aided by the rearward thrust of the taut capsular rim against the lens haptics36 causes rearward flexing of the lens from its initial position ofFIG. 5 to its position ofFIG. 6. The lens haptics36 are made sufficiently rigid that they will not buckle under the forces of fibrosis. At the conclusion of fibrosis, the lens occupies its posterior position ofFIG. 6 wherein the lens presses rearwardly against theelastic posterior capsule24 and stretches this capsule rearwardly. The posterior capsule then exerts a forward elastic bias force on the lens. This posterior position of the lens is its distant vision position.
• Natural accommodation in a normal human eye involves shaping of the natural crystalline lens by automatic contraction and relaxation of the ciliary muscle of the eye by the brain to focus the eye at different distances. Ciliary muscle relaxation shapes the natural lens for distant vision. Ciliary muscle contraction shapes the natural lens for near vision.
• The accommodatingintraocular lens32 is uniquely constructed to utilize this same ciliary muscle action, the fibrosedcapsular rim22, theelastic posterior capsule24, and the vitreous pressure within thevitreous cavity21 to effect accommodation movement of thelens optic34 along the optic axis of the eye between its distant vision position ofFIG. 6 to its near vision position ofFIG. 8. Thus, when looking at a distant scene, the brain relaxes theciliary muscles28. Relaxation of the ciliary muscle stretches thecapsular bag20 to its maximum diameter and its fibrosedanterior rim22 to the taut condition or position discussed above. The taut rim deflects the lens rearwardly to its posterior distant vision position ofFIG. 6 in which theelastic posterior capsule24 is stretched rearwardly relative to the general plane of the fibrosed haptic end portions, by the lens and thereby exerts a forward bias force on the lens. When looking at a near scene, such as a book when reading, the brain constricts or contracts the ciliary muscle. This ciliary muscle contraction has the three-fold effect of increasing the vitreous cavity pressure, relaxing thecapsular bag20 and particularly its fibrosedcapsular rim22, and exerting opposing endwise compression forces on the ends of the lens haptics36 with resultant endwise compression of the lens. Relaxation of the capsular rim permits the rim to flex forwardly and thereby enables the combined forward bias force exerted on the lens by the rearwardly stretched posterior capsule and the increased vitreous cavity pressure to push the lens forwardly relative to the general plane of the fibrosed haptic end portions, in an initial accommodation movement from the position ofFIG. 6 to the intermediate accommodation position ofFIG. 7.
• In this intermediate accommodation position, the lens is substantially flat, and the ends of the lens haptics and theirhinges38 are disposed substantially in a common plane normal to the axis of the eye. Prior to accommodation, the lens arches rearwardly so that endwise compression of the lens by ciliary muscle contraction tends to produce a rearward buckling force on the lens. However, the increased vitreous cavity pressure and the forward bias force of the stretched posterior capsule are sufficient to overcome this opposing rearward buckling force and effect forward accommodation movement of the lens to and at least just slightly beyond the intermediate position ofFIG. 7. At this point, endwise compression of the lens by the contracted ciliary muscle produces a forward flexing force on the lens which effects final accommodation of the lens beyond the intermediate position ofFIG. 7 to the near vision position ofFIG. 8. Subsequent brain-induced relaxation of theciliary muscle28 in response to looking at a distant scene reduces the vitreous cavity pressure, stretches thecapsular bag20 to its maximum diameter, and restores the anterior capsular rim22 to its taut trampoline-like condition to effect return of the lens to its distant viewing position ofFIG. 6. During accommodation, thelens optic34 moves along the axis of the eye. The effective power of the optic is selected by the brain to sharply focus incoming light by moving the optic along the axis of the eye by contraction and relaxation of the ciliary muscle.
• The lens haptics36 flex at theirhinges38 with respect to thelens optic34 during accommodation. Any elastic strain energy forces developed in the hinges during this flexing produces additional anterior and/or posterior forces on the lens. For example, assume that the lens is relatively flat, i.e., that the lens haptics36 lie in a common plane as shown inFIG. 1, in the normal unstressed state of the lens. In this case, posterior deflection of the lens from its position ofFIG. 1 to its distant vision position ofFIG. 6 creates elastic strain energy forces in thehinges38 which urge the lens forwardly back to its unstressed position ofFIG. 1 and thus aid the above discussed initial accommodation of the lens in response to contraction of the ciliary muscle. Final accommodation flexing of the lens from its intermediate position ofFIG. 7 to its near vision position ofFIG. 8 creates elastic strain energy forces in thehinges38 which urge the lens rearwardly toward its unstressed position and thus aid initial return of the lens from its near vision position to its distant vision position in response to relaxation of the ciliary muscle. The lens may be designed to assume some other normal unstressed position, of course, in which case any elastic strain energy forces created in the lens during flexing of the haptics will aid, resist, or both aid and resist accommodation of the lens to its near vision position and return of the lens to its distant vision position depending upon the unstressed position of the lens.
• During accommodation, the lenshaptic plates36aslide endwise in their fibrosed tissue pockets42. As shown best inFIGS. 1, 2 and4, the haptics are tapered endwise in width and thickness to enable the haptics to move freely in the pockets. Thelens optic34 moves forwardly toward and rearwardly away from the anteriorcapsular rim22. The diameter of the optic is made as large as possible to maximize its optical imaging efficiency. The optic is preferably but not necessarily made smaller than the diameter of the anterior capsule opening26 to permit accommodation movement of the optic into and from the opening without interference by thecapsular rim22 in order to maximize the accommodation range.
• The modified accommodatingintraocular lens100 shown inFIGS. 9 and 10 is identical to thelens32 shown inFIGS. 1-8 except as noted below. Thus the modified lens has an optic102 and generally T-shapedhaptics104 extending radially out from diametrically opposite edges of the optic. These haptics include longitudinally taperedhaptic plates106 and flexiblehaptic fingers108 at the outer ends of these plates extending laterally out from the longitudinal edges of the plates. The modifiedlens100 differs from thelens32 only in that the haptic hinges38 and hingegrooves40 of thelens32 are omitted in the modifiedlens100, and thehaptic plates106 of the modified lens are made resiliently flexible or bendable throughout their length, as indicated in broken lines inFIG. 10. The modified lens is implanted in a capsular bag of a human eye and provides vision accommodation in response to ciliary muscle contraction and relaxation in the same manner as described in connection with thelens32.
• The accommodatingintraocular lens110 ofFIG. 11 differs from the earlier-described lenses, in that it embodies an optic112 from which extend threehaptics36aextending radially outward. Haptic36aincludes a longitudinally taperedhaptic plate114 and flexiblehaptic fingers36b. Although three haptics are shown, it will be understood that four or even more haptics can be provided. Like the lenses earlier described, thelens110 is implanted in the capsular bag of a patient's eye and provides vision accommodation in response to ciliary muscle contraction and relaxation. The multiple haptics of thelens110, which can be three or more in number, are equally spaced about the axis of the optic112 and provide improved centration of the lens in the capsular bag of the eye with thelens optic112 aligned with the anterior opening in the bag.
• The accommodatingintraocular lens200 ofFIGS. 12-15 is identical to the lens ofFIGS. 1-8 except that the plate portions of the T-shaped extended portions orplate haptics202 oflens200 increase in thickness from their outer tip ends toward their inner junctures with the optic204. The thickened portions of the haptics have convexly curvedposterior surfaces206 which curve rearwardly beyond the posterior surface of the optic204 and away from the anterior surfaces of the haptics for major portions of the haptic lengths from the outer haptic ends toward the inner haptic ends. The posterior haptic surfaces then curve forwardly toward the anterior haptic surfaces at the inner haptic ends to form thinnedflexible hinge portions208 pivotally joining the haptics to the optic.
• Thelens200 is implanted within the capsular bag of a patient's eye in the initial position ofFIG. 12, after which fibrosis is permitted to occur about the lens haptics202 with the ciliary muscle paralyzed in its relaxed state, all in the same manner as explained earlier in connection withFIGS. 1-8. As inFIGS. 1-8, the lens is urged rearwardly toward theposterior capsule24 of thecapsular bag20 during fibrosis to the posterior distant vision position ofFIG. 13. In this posterior position, the rearwardly projectingposterior surfaces206 of the haptics contact theposterior capsule24 and space the posterior surface of the optic204 from the capsule.
• Contraction of the ciliary muscle during normal vision accommodation after fibrosis is complete increases vitreous pressure and compresses thelens200 radially or endwise. The increasing vitreous pressure produced by such muscle contraction together with the rearwardly stretchedposterior capsule24 exert anterior forces, indicated by the arrows V inFIG. 13, on the rearwardly projecting thickenedhaptics202. These forces move thelens optic204 anteriorly for accommodation in much the same manner as explained above in connection withFIGS. 1-8 except for the following haptic movement. During accommodation oflens200, the arcuate posterior surfaces206 of the thickenedhaptics202 slide inwardly acrossposterior capsule24, and the inner ends of the haptics rotate forwardly while their outer ends remain in contact with the posterior capsule, as shown inFIGS. 13-16. This increases the anterior accommodation movement of the optic from its posterior distant vision position ofFIG. 13, through its midrange position ofFIG. 14, to its near vision position ofFIG. 15. When the ciliary muscle relaxes, it radially stretches the capsular bag of the eye and thereby pulls radially out on the encapsulated T-shaped ends of the lens haptics202 to aid return of the lens to its posterior distant vision position.
• Thickening thelens haptics202 in the manner shown and described provides two advantages in addition to the above mentioned advantage of increasing the accommodation amplitude of thelens optic204. One of these additional advantages resides in the fact that rearwardly thickening the haptics increases the spacing, along the axis of the optic, between thehaptic hinges208 and the posterior portion of the lens which contacts theposterior capsule24, in this case the posteriorhaptic surfaces206. Increasing this spacing has the effect of shifting the hinges forwardly relative to theposterior capsule24 and hence forwardly relative to the plane P inFIG. 13 (tip plane) passing through the outer tips of the lens haptics202 normal to the optic axis when the lens occupies its posterior distant vision position. This forward shift of the hinges relative to the haptic tip plane P, in turn, increases the portion of ciliary muscle contraction during accommodation over which the haptic hinges are located forwardly of the tip plane and hence the portion of such muscle contraction over which compression of thelens200 by such muscle contraction produces an anterior force on the lens optic which aids vitreous pressure in moving the optic forwardly in accommodation and thereby further increases the accommodation amplitude of the lens.
• The second additional advantage of thickening thelens haptics202 in the manner illustrated (i.e. so that they protrude rearwardly beyond the posterior surface of the lens optic204) spaces this posterior optic surface from theposterior capsule24, as shown inFIGS. 13-15. This spacing permits a laser capsulotomy to be performed on the posterior capsule, if it becomes cloudy, by sharply focusing a YAG laser beam on the capsule through the cornea of the eye and thelens optic204 without the danger of contacting the intense laser beam focus point with the posterior surface of the optic with which would pit or otherwise degrade this optic surface.
• It is worthwhile to recall here that accommodating intraocular lenses of the invention conform to one or the other of the following basic lens configurations: (a) a posteriorly biased lens configuration in which the hinges or inner ends of the extended portions or haptics of the lens are located posteriorly of or approximately in a tip plane passing through the outer tips of the extended portions or haptics normal to the optic axis when the lens occupies its posterior distant vision position, (b) an anteriorly biased lens configuration in which the hinges or inner ends of the extended portions or haptics are located forwardly of the tip plane when the lens occupies its posterior distant vision position. The accommodating intraocular lenses described to this point are posteriorly biased lenses.
• In this regard, it will be seen that thelenses32,200 are sized and shaped so that when they assume or occupy their distant vision configurations (i.e. the configurations which the lenses assume or occupy in their posterior distant vision positions ofFIGS. 6 and 13), their haptic hinges38,208 are located rearwardly of a plane P (tip plane) passing through the outer tips of thelens haptics36,202 normal to the optical axis of thelens optics34,204. This relationship is attained by sizing and shaping each lens in such a way that the distance or spacing along the optical axis of its optic between the posterior portion(s) of the lens which contact(s) theposterior capsule24 of the patient's eye (i.e. the posterior surface of thelens optic34 inFIG. 6 and theposterior surfaces206 of the thickenedlens haptics202 inFIG. 13) and the lens hinges38,208 is less than the distance or spacing along the axis of the eye between the portion(s) of the posterior capsule contacted by the lens and a plane (tip plane P) passing through the annular haptic-tip-receiving sulcus of thecapsular bag20 normal to the axis of the eye.
• It is evident fromFIGS. 6 and 13 that radial or endwise compression of posteriorly biasedlenses32,200 by contraction of the ciliary muscle during accommodation initially urges thelens optics34,204 rearwardly in opposition to the combined anterior forces of the stretched posterior capsule and the increasing vitreous pressure. These anterior forces are dominant and move the lens optics anteriorly against the opposing posterior bias forces produced by ciliary muscle compression of the lenses to effect vision accommodation, as explained earlier. Initial movement of the haptic hinges38,208 during this accommodation occurs forwardly to the mid-range lens positions ofFIGS. 7, 14 in which the hinges are located approximately in their tip planes P. Continued compression of the lenses by ciliary muscle contraction at this point moves the hinges forwardly of their tip planes, whereupon the bias forces produced on thelens optics32,204 by such lens compression reverse to become anterior forces which aid further anterior accommodation movement of the lenses by vitreous pressure to their near vision positions ofFIGS. 8, 12. Relaxation of the ciliary muscle reduces vitreous pressure and stretches the capsular bags radially which pulls the encapsulated T-shaped outer ends of the haptics radially outward to aid return of the lenses to their posterior distant vision positions ofFIGS. 6, 13.
• Referring now toFIGS. 16-18, there is illustrated an anteriorly biased accommodatingintraocular lens300 according to the invention in its posterior distant vision position within thecapsular bag20 of a patient's eye.Lens300 is identical tolens200 except in the following respects. Theanterior surfaces302 of the thickened T-shaped extended portions orplate haptics304 oflens300 are flush with the anterior surface of thelens optic306. The posteriorhaptic surfaces308 incline rearwardly away from the anteriorhaptic surfaces302 from the outer haptic tips toward their inner junctions with the optic306 and then forwardly toward the anterior haptic surfaces to define, with the peripheral edge of the optic, posterior V-shaped notches which form thinnedflexible hinges310 at the inner haptic ends. The optic306 has a convexly roundedposterior surface312.
• Lens300 is implanted in thecapsular bag20 in the same way as the earlier described lenses and is subjected to the same ciliary muscle contraction and relaxation as the earlier described lenses during normal vision accommodation following completion of fibrosis.Lens300 is so sized and shaped that theposterior surfaces308 of itshaptics304 and theposterior surface312 of its optic306 contact theposterior capsule24 of thebag20. When thelens300 occupies its posterior distant vision configuration ofFIGS. 16-18 which it assumes in its posterior distant vision position shown in the latter figures, itshinges310 are located a small distance forwardly of the haptic tip plane P of the lens, i.e a plane passing through the outer tips of thehaptics304 and the annular haptic-tip-receiving sulcus of thecapsular bag20 normal to the axis of the lens and the eye. Accordingly, during ciliary muscle contraction in the course of normal accommodation, end to end or radial compression of thelens300 and vitreous pressure both exert anterior accommodation forces on thelens optic306 throughout its full accommodation range. This combined action of the two forces increases the accommodation amplitude and hence diopters of accommodation of the lens.
• FIGS. 19 and 20 illustrate two modified anterior biased accommodatingintraocular lenses300aand300baccording to the invention implanted within acapsular bag20 of a patient's eye. These modified anterior biased lenses are identical to and undergo accommodation in much the same manner as the anterior biased lens ofFIGS. 16-18 with the following exceptions. Inlens300a, only the posterior surfaces304aof the T-shaped extended portions or plate haptics302aof the lens contact theposterior capsule24 of the capsular bag. Accordingly, vitreous pressure acts only on these haptics during accommodation, and the lens optic is immune to laser damage during laser capsulotomy of the posterior capsule, as in thelens200 ofFIGS. 12-15. The posterior surface312aof the lens optic306ais spaced from the posterior capsule. Inlens300b, only the posterior surface312bof thelens optic306bcontacts theposterior capsule24 of the capsular bag. The posterior surfaces304bof the T-shaped plate haptics302bof the lens are spaced from the posterior capsule. Accordingly, during accommodation, vitreous pressure acts only on the posterior surface of the optic.
• All of the accommodating intraocular lenses of the invention described to this point, except the lens ofFIGS. 9 and 10, have hinged extended portions in the form of haptics with resiliently flexible haptic hinges.FIGS. 21-23 illustrate modified lenses having extended portions in the form of pivotally hinged haptics. The lens400aofFIG. 21 includes a central optic402aand T-shaped plate haptics404a(only one shown) spaced circumferentially about and joined by pivotal hinges406ato the edge of the optic. Each haptic hinge406acomprises mating hinge portions408a,410aon the respective haptic and the optic which pivotally interengage to pivotally connect the haptics to the optic for anterior and posterior movement of the haptics relative to the optic. InFIG. 21, each haptic hinge portion408acomprises a tongue412aintegrally molded or otherwise formed along the inner end of and coplanar with the respective haptic plate portion414aand having a generally cylindrical bead416 along the inner edge of the tongue. Each optic hinge portion410aincludes a hinge groove or channel418aalong the edge of the optic402awhich opens laterally outward toward the haptic. Each hinge groove418ais cylidrically curved, undercut and sized in transverse cross-section to pivotally receive the bead416aon the adjacent haptic tongue412ain such a way that the bead is captivated in the groove, and the respective haptic404ais pivotally movable through a certain angle anteriorly and posteriorly relative to the optic.
• The optic402aand each haptic plate414amay be molded or otherwise fabricated from any suitable intraocular lens material including the intraocular lens materials listed earlier. All of these materials have suitable optical and other qualities for an intraocular lens. Some of these materials are sufficiently hard or firm to permit each haptic hinge tongue412ato be molded or otherwise formed integrally with its haptic plate414aand each haptic hinge groove418ato be molded or otherwise formed directly in the material of the lens optic402a, as in the lens400aofFIG. 21.
• The modified accommodatingintraocular lenses400bofFIGS. 22 and 400cofFIG. 23 are essentially identical to lens400aofFIG. 21 except in the following respects. The optics and haptic plates oflenses400b,400care made from a material which is not sufficiently firm or hard to use for hinge purposes, and their hinge formations are separately fabricated from intraocular lens materials which are suitably hard or firm for hinge purposes and which form reinforcing hinge inserts or inlays that are molded within the optics and the haptic plates of thelenses400b,400c. For this reason, the parts oflenses400b,400care designated by the same reference numerals as their corresponding parts of lens400abut with the subscripts b or c, as the case may be.
• With the foregoing in mind, each extended portion or haptic404boflens400bcomprises an elongate hinge plate420bwhich is encapsulated within, extends edgewise through, and forms a reinforcing insert or inlay within the respective haptic plate414b. At the inner end of this hinge plate is a cross-bar422bwhich projects edgewise beyond the inner end of the haptic plate414bto form the tongue412bof the respective haptic hinge portion408b. At the outer end of each hinge plate420bare flexible fingers424bwhich provide the lens haptic404bwith its T-shape. Each optic hinge portion410bcomprises a bar which is encapsulated within and forms a reinforcing insert or inlay in the edge of thelens optic402b. Along the outer edge of this bar is the hinge groove or channel418bwhich pivotally receives the cylindrical bead416balong the adjacent hinge tongue412b.
• The modifiedlens400cofFIG. 23 is identical tolens400bexcept that the inner end of each haptic plate414coflens400cextends endwise beyond the inner cross bar422cof the reinforcing hinge plate408bwhich forms the respective haptic hinge portion408coflens400c. This extending inner end of each haptic plate414chas a cylindrically rounded surface and a central slot426c. Each optic hinge portion410ccomprises a hinge bar428cencapsulated in the edge of the lens optic402cand having a central rounded hinge projection430c. This hinge projection fits rotatably within the notch426cof the adjacent haptic hinge portion408cand is pivotally connected to the haptic hinge portion, to form the respectivehaptic hinge406c, by a hinge pin432 which extends through aligned bores in the haptic hinge portion and the optic hinge projection.
• The modified accommodatingintraocular lens500 ofFIG. 24 has extended portions in the form of flexibly hingedplate haptics501 including flexiblehaptic plate portions502 integral with and extending radially out from edges of thelens optic504. These haptic plate portions havecutouts506 including tapered longitudinal outer ends508 which widen toward and open through the outer ends of the haptics and arcuateinner end slots510 which extend laterally toward the longitudinal edges of the haptics to form flexiblehaptic hinges512 between the outer ends of the slots and the longitudinal edges of the haptic portions. Haptics501 are reinforced longitudinally outward of thehinges512 by T-shapedinserts514 having taperedinner end portions516 fixed within the tapered outer ends508 of thehaptic cutouts506.Lens500 is implanted in the eye in the same manner as the earlier described lens and flexes at itsflexible hinges512 during contraction and relaxation of the ciliary muscle to effect vision accommodation.
• FIGS. 25-28 illustrate a presently preferred accommodatingintraocular lens600 according to the invention implanted within acapsular bag20 of a patient's eye. This preferred lens is an anteriorly biased lens with flexibly hinged extended portions in the form of T-shaped haptics which achieves increased accommodation amplitude and increased diopters of accommodation by the combined action of (a) its anteriorly biassed configuration which increases accommodation amplitude and increased diopters of accommodation in the manner explained earlier, and (b) increased power of its optic which increases the amount of accommodation produced by any given amount of accommodation movement of the lens optic or, coversely reduces the accommodation movement of the optic required to produce any given amount of accommodation.
• Lens600 comprises a one piece lens structure having acentral optic602 and flexibly hingedextended portions604 in the form of T-shaped plate haptics extending generally radially out from the optic. Each plate haptic604 is longitudinally tapered in width and thickness so as to widen in width and increase in thickness toward its inner end. Each plate haptic includes aninner plate portion606 which is integrally joined to an edge of the optic602 and inclines anteriorly relative to the optic toward its outer end, anouter plate portion608 joined to the outer end of the inner plate portion, and a V-groove610 entering the posterior side of the haptic at the juncture of these plate portions so as to form at this juncture aflexible hinge612. Theouter plate portion608 is pivotally movable at this hinge anteriorly and posteriorly relative to theinner plate portion606 and the optic602. The lens structure including itsoptic602 andhaptic plate portions606,608 is molded or otherwise formed as a unitary lens structure from a lens material mentioned earlier and has T-shapedinserts614 fixed in the outer ends of the outerhaptic plate portions608. These inserts provide the lens extended portions orhaptics604 with their T-shape and may be utilized to reinforce the outerhaptic plate portions608 if necessary.
• Lens600 is implanted in thecapsular bag20 of the eye with the ciliary muscle of the eye paralyzed in its relaxed state and maintained in this paralyzed state until the completion of fibrosis, all in the same manner as explained earlier. During this fibrosis, thelens optic602 is urged posteriorly to its distant vision position shown in solid lines inFIG. 25 and dashed lines inFIG. 28 wherein the posterior surface of the optic presses rearwardly against theposterior capsule24 of the capsular bag and stretches this posterior capsule rearwardly. The configuration which thelens600 assumes or occupies in this posterior distant vision position is its posterior distant vision configuration. Ciliary muscle contraction during normal vision accommodation following completion of fibrosis increases vitreous pressure and compresses the lenses radially or endwise to effect anterior accommodation movement of thelens optic602 in the same manner as explained earlier.
• As mentioned above,lens600 is an anteriorly biased lens. In this regard, it will be observed inFIGS. 25 and 28 that when the lens occupies its posterior distant vision position, itshaptic hinges612 are located forwardly of a tip plane PT passing through the outer tips of the lens haptics604 normal to the axis of thelens optic602 and the eye. Accordingly, compression of the lens by ciliary muscle contraction during normal vision accommodation is effective to produce an anterior accommodation force on the optic throughout its entire accommodation range from its posterior distant vision through its mid-range position (solid lines inFIG. 28) to its anterior near vision position (phantom lines inFIG. 28). Compression of the lens by ciliary muscle contraction thereby aids the anterior vitreous pressure force on the optic throughout its entire accommodation range and thereby increases the accommodation amplitude and diopters of accommodation of the lenses, as explained earlier.
• An important feature oflens600 resides in the fact that itsoptic602 has increased optical or dioptic power which aids the anterior biased configuration of the lens to further increase accommodation amplitude and diopters of accommodation. To this end, theanterior face616 of the optic is relatively flat or just slightly convex while theposterior face618 of the optic has a relatively steep convex curvature such that the optic has a generally planoconvex shape. This optic shape locates most or all of the optical power of the optic at the posterior side of the optic. Increasing the power of the lens optic in this way decreases the distance through which the optic must move to produce any given amount of vision accommodation and, conversely, increases the amount of vision accommodation produced by any given accommodation movement of the optic and thereby increases the maximum accommodation amplitude and diopters of accommodation of the lens.
• Increasing the power of an intraocular lens optic at the posterior side of the optic, as inFIGS. 25-28, shifts the optical plane of the optic (i.e. plane from which the focal point of the optic originates) rearwardly toward theretina16 of the eye. For example, the optical plane P_Ooflens optic602 is located at the approximate position shown inFIG. 25 which is rearwardly of the optical plane position (not shown) of a symmetrical biconvex optic of the same center thickness measured along the axis of the optic but having anterior and posterior surfaces of equal curvature). This rearward shift of the optical plane of the optic toward the retina must be compensated for by increasing the dioptic power of the optic in order to sharply focus incoming light rays on the retina. The required increase in the power ofoptic602 is accomplished by appropriately shaping the steep convex curvature of theposterior surface618 of the optic.
• At this point, refer again toFIGS. 16-20 in which it will be observed that the lens illustrated in each of these figures includes a central optic whose posterior surface has a greater convex curvature than its anterior surface. Accordingly, the lens optic illustrated in each of theFIGS. 16-20 is a “rear power” optic most of whose optical power is provided by the posterior surface of the optic. Accordingly, the lenses ofFIGS. 16-20 provide increased accommodation amplitude and diopters of accommodation in essentially the same manner as explained above in connection withFIGS. 25-28.

Claims (37)

1. An accommodating intraocular lens for implantation into a generally circular inner surface of an eye, comprising:

(a) a lens body having an optic and having at least two haptics,

(b) each of the haptics including an outer portion with an outer surface adapted to engage the generally circular inner surface of the eye, at least part of said outer surface extending beyond the diameter of the generally circular inner surface of the eye when said outer portion is in its unstressed state, said outer portion being flexible and not conforming to the generally circular inner surface of the eye until subjected to compressive forces so that the outer surface will conform generally to the shape of the inner surface of the eye when subjected to said compression forces upon implantation; and

(c) the optic being moveable anteriorly and posteriorly relative to the haptics in response to forces imparted to the lens through contraction and expansion of the generally circular inner surface of the eye.

2. The lens ofclaim 1 wherein each haptic is a plate haptic.

3. The lens ofclaim 1 wherein the haptics and lens body are formed from different optical material.

4. The lens ofclaim 1 wherein the optic is circular.

5. The lens ofclaim 1 wherein two or more haptics extend from opposite sides of the optic.

6. The lens ofclaim 1 wherein the haptics include opposed longitudinal edges that are parallel to each other.

7. The lens ofclaim 1 wherein the haptics include opposed longitudinal edges that taper inwardly as they extend from the optic.

8. The lens ofclaim 1 wherein the haptics include upper and lower surfaces that taper inwardly as they extend from the optic.

9. The lens ofclaim 1 wherein each haptic includes an outer end and said outer portion includes a pair of fingers extending from the outer end.

10. The lens ofclaim 9 wherein the fingers are formed integrally with each haptic.

11. The lens ofclaim 9 wherein the fingers are attached to the outer end of each haptic.

12. The lens ofclaim 9 wherein the fingers extend from opposite sides of each haptic.

13. The lens ofclaim 1 wherein the haptics have hinge portions including at least one cylindrically rounded surface with a central bore and at least one notch,

the optic has hinge portions including at least one cylindrically rounded surface with a central bore and at least one notch,

wherein the haptic rounded surface fits rotatably with the optic hinge portion notch, and the optic rounded surface fits rotatably with the haptic hinge portion notch.

14. The lens according toclaim 2 having extending portions from the plates which are T shaped.

15. The lens according toclaim 1 having a hinge across the haptic adjacent to the optic.

16. The lens according toclaim 1 having a thinned area across the haptic adjacent to the optic.

17. The lens according toclaim 1 wherein the optic for distance vision is anterior to the outer ends of the haptics and moves further anteriorly for near vision.

18. The lens according toclaim 1 wherein the optic is posterior to the outer ends of the haptics and moves anteriorly, but not to a uniplanar position, for near vision.

19. The lens ofclaim 13 further comprising a hinge pin extending through aligned bores in the haptic portions and optic hinge portions.

20. An accommodating intraocular lens for implantation into a generally circular inner surface of the eye, comprising:

(a) an optic,

(b) at least two optic hinge portions attached to the periphery of said optic,

(c) at least two haptics pivotally connected to said optic hinge portions, said haptics adapted to engage the generally circular inner surface of the eye for holding the lens in the eye;

(d) each of the haptics including an outer portion with an outer surface adapted to engage the generally circular inner surface of the eye, at least part of said outer surface extending beyond the diameter of the generally circular inner surface of the eye when said outer portion is in its unstressed state, said outer portion being flexible and not conforming to the generally circular inner surface of the eye until subjected to compressive forces so that the outer surface will conform generally to the shape of the inner surface of the eye when subjected to said compression forces upon implantation; and

(e) the haptics being pivotally moveable through a certain angle anteriorly and posteriorly relative to the optic in response to forces imparted to the lens through contraction and expansion of the generally circular inner surface of the eye.

21. The lens ofclaim 20 wherein the haptics are detachably removable from the optic hinge portions.

22. The lens ofclaim 20 wherein each haptic is a plate haptic.

23. The lens ofclaim 20 wherein the haptics and optic are formed from different material.

24. The lens ofclaim 20 wherein the optic is circular.

25. The lens ofclaim 20 wherein two haptics extend from opposite sides of the optic.

26. The lens ofclaim 20 wherein the haptics include opposed longitudinal edges that are parallel to each other.

27. The lens ofclaim 20 wherein the haptics include opposed longitudinal edges that taper inwardly as they extend from the optic.

28. The lens ofclaim 20 wherein the haptics include upper and lower surfaces that taper inwardly as they extend from the optic.

29. The lens ofclaim 20 wherein each haptic includes an outer end and said outer portion includes a pair of fingers extending from the outer end.

30. The lens ofclaim 29 wherein the fingers are formed integrally with each haptic.

31. The lens ofclaim 29 wherein the fingers are attached to the outer end of each haptic.

32. The lens ofclaim 29 wherein the fingers extend from opposite sides of each haptic.

33. The lens ofclaim 20 wherein the haptics include at least one cylindrically rounded surface with a central bore and at least one notch,

the optic has hinge portions including at least one cylindrically rounded surface with a central bore and at least one notch,

wherein the haptic rounded surface fits rotatably with the optic hinge portion notch, and the optic rounded surface fits rotatably with the haptic notch.

34. The lens ofclaim 33 further comprising a hinge pin extending through aligned bores in the haptic and the optic hinge portions.

35. The lens ofclaim 1 wherein the optic can start in an anterior position, move forward, and return to its original anterior position, moving anteriorly and posteriorly relative to the outer ends of the haptics.

36. The lens ofclaim 1 wherein the optic can start posteriorly to the outer ends of the haptics, and move anteriorly, and be posterior to the outer ends of the haptics, and return to its original position for accommodation.

37. The lens ofclaim 1 wherein the optic can start posteriorly to the outer ends of the haptics, and move anteriorly, anterior to the outer ends of the haptics for accommodation.

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