HK1234303B - Two-part accommodating intraocular lens device - Google Patents

Description

Two-component accommodative intraocular lens device

Technical Field

The present invention relates generally to accommodating intraocular lens devices, and more particularly to accommodating intraocular lens devices configured for implantation in the lens capsule of a subject's eye.

Background Art

Surgery of the eye is on the rise as technological advances allow for complex interventions to address a variety of ophthalmic conditions. Patient adoption has increased in the last two decades as this procedure has been shown to be generally safe and can significantly improve a patient's quality of life.

Cataract surgery remains one of the most common surgical procedures, with more than 16 million cataract surgeries performed worldwide. As life expectancy continues to rise, it is expected that this number will continue to increase. Cataracts are typically treated by removing the lens from the eye and implanting an intraocular lens (IOL) in its place. Because conventional IOL devices focus primarily on distance vision, they cannot correct presbyopia and still require reading glasses. Therefore, although patients who have undergone standard IOL implants no longer experience the clouding of their eyes due to cataracts, they are unable to adjust or change the focal length from near to far, from far to near, and at distances in between.

Surgical procedures to correct refractive errors of the eye have also become very common, with laser vision correction surgery (LASIK) becoming very popular, with over 700,000 procedures performed each year. Given the high prevalence of refractive errors and the relative safety and effectiveness of this surgery, it is expected that more and more people will turn to LASIK or other surgical procedures rather than conventional glasses or contact lenses. Despite the success of LASIK in treating myopia, there remains an unmet need for an effective surgical intervention to correct presbyopia, which cannot be treated by conventional LASIK surgery.

Because nearly every cataract patient also suffers from presbyopia, there is a growing market demand for treatments for these conditions. While implantable intraocular lenses are widely accepted by physicians and patients for cataract treatment, similar surgeries for correcting presbyopia only account for 5% of the US cataract market. Therefore, there is a need to address ophthalmic cataracts and/or presbyopia in an aging population.

Summary of the Invention

The dual-component accommodating IOL devices disclosed herein provide several advantages due to their independent dual-component construction. Implanting the IOL device requires a significantly reduced incision size because the two components of the IOL device are implanted separately, thereby significantly reducing the delivery profile for implantation. The reduced incision size provides several advantages, including avoiding the need for anesthesia and suturing to close the incision site, and improving surgical outcomes.

Furthermore, more control can be provided during surgery to adjust the size and power of the IOL. Implantation of the primary lens into the lens capsule will provide the surgeon with an impression of the size of the patient's lens capsule and will therefore help confirm the corrective size of the subsequently implanted power-varying lens.

In one embodiment, a two-component accommodating intraocular lens (IOL) device for implantation within the capsular bag of a patient's eye is described. The IOL device includes a main lens assembly and a focal-varying lens assembly. The main lens assembly includes a fixed lens and a centering member disposed at a periphery of the fixed lens. The centering member has a circumferential distal edge and a first coupling surface proximate the circumferential distal edge. The focal-varying lens includes a closed lens cavity filled with a fluid or gel and a haptic system disposed at a periphery of the lens cavity. The haptic system has a peripheral engagement edge configured to contact the capsular bag and a second coupling surface facing the first coupling surface and positioned adjacent to the peripheral engagement edge. The first and second coupling surfaces are in sliding contact with each other to allow the focal-varying lens to move relative to the main lens assembly. When the focal-varying lens is radially compressed, the first and second coupling surfaces maintain a spaced relationship between the fixed lens and the lens cavity.

According to a first aspect, in the absence of radial compression, the diameter d ₁ of the power variation lens is greater than the diameter d ₂ of the main lens component.

According to a second aspect, the fixed lens does not change shape or curvature during accommodation.

According to a third aspect, during accommodation, the lens chamber changes both shape and curvature.

According to a fourth aspect, the fixed lens and the lens cavity are plus-power lenses.

According to a fifth aspect, the fluid or gel filled lens chamber is a biconvex lens.

According to a sixth aspect, a fixed lens assembly includes a right-angled edge positioned circumferentially around the fixed lens outside the optic zone.

According to a seventh aspect, the facing surfaces of the centering member and the haptic system each comprise one of a complementary and interlocking pair, the interlocking pairs being circumferentially disposed about the fixed lens and the power varying lens, respectively.

According to an eighth aspect, the peripheral engagement edge is thicker than the circumferential distal edge.

According to a ninth aspect, a thickness ratio of the circumferential distal edge to the peripheral joining edge ranges from about 1:5 to about 1:2.

According to a tenth aspect, the primary lens assembly has a higher Young's modulus of elasticity than the power-varying lens.

According to an eleventh aspect, at least one of the centering member and the haptic system includes a plurality of openings.

According to the twelfth aspect, the variable power lens includes two opposing surfaces that are displaced away from each other when a radial force acts along the peripheral edge, the two opposing surfaces having a central region and a peripheral region and a thickness profile that gradually increases from the peripheral region to the central region.

In another embodiment, a two-component accommodating intraocular lens (IOL) device for implantation within the capsular bag of a patient's eye is described. The IOL includes a main lens assembly and a focal-varying lens assembly. The main lens assembly includes a fixed lens and a centering member disposed about the periphery of the fixed lens. The centering member has a radially compressible peripheral edge having an outer circumferential surface configured to engage the capsular bag of the patient's eye and an inner circumferential surface spaced radially inward from the outer circumferential surface. The focal-varying lens includes a closed, fluid- or gel-filled lens cavity and a haptic system disposed about the periphery of the lens cavity. The haptic system has a circumferential edge configured to engage the inner circumferential surface. Radial compression acting on the outer circumferential surface causes at least one of an increase in curvature and a decrease in diameter of the lens cavity, and radial compression acting on the outer circumferential surface does not cause an increase in curvature of the fixed lens or a decrease in diameter thereof.

According to a first aspect, the centering member further comprises a circumferential hinge between the fixed lens and the peripheral edge, the circumferential hinge being provided on opposite sides of the centering member.

According to a second aspect, the centering member further comprises a single circumferential hinge between the fixed lens and the peripheral edge.

According to a third aspect, the circumferential hinge is provided on the interior surface of the haptic facing the power varying lens.

According to a fourth aspect, the circumferential edge of the haptic system and the inner circumferential surface of the peripheral edge have complementary rounded surfaces, and radial compression acting on the outer circumferential surface causes the peripheral edge to tilt radially inwardly about the circumferential hinge.

According to a fifth aspect, the power varying lens is entirely contained within the peripheral edge of the main lens assembly.

According to a sixth aspect, the variable power lens further includes a circumferential lip disposed radially inwardly from the inner surface of the circumferential edge.

According to the seventh aspect, the focal length-varying lens comprises two relative surfaces that shift away from each other when a radial force acts along the peripheral edge, the two relative surfaces having a central area and a peripheral area, wherein the thickness of the central area is at least twice, preferably at least three times and more preferably at least four times the thickness of the peripheral area.

In a further embodiment, a method of implanting a dual-component IOL device into the capsular bag of a patient's eye is described. The method includes first inserting and positioning a primary lens assembly into the capsular bag of the patient's eye through an incision located in the cornea, the primary lens having a fixed lens and a centering member disposed peripherally of the fixed lens. The next step includes inserting and positioning a variable power lens into the capsular bag of the patient's eye in front of the primary lens assembly, the variable power lens including a lens cavity that is enclosed and filled with a fluid or gel and a haptic system disposed peripherally of the lens cavity, the haptic system having a peripheral engagement edge configured to contact the capsular bag. The primary lens assembly contacts the posterior portion of the capsular bag and the variable power lens contacts the anterior portion of the capsular bag after implantation. The fixed lens and the lens cavity are centered about an optical axis.

According to the first aspect, the incision is smaller than 5 mm, preferably smaller than 4 mm, and more preferably smaller than 3 mm.

According to a second aspect, both inserting steps are performed through incision.

According to a third aspect, the method further comprises injecting a viscoelastic material prior to inserting and seating the power-changing lens.

Other purposes, features and advantages of the preferred embodiments will be apparent to those skilled in the art upon reading the following detailed description. However, it will be understood that when referring to preferred embodiments of the present invention, the detailed description and specific examples are provided by way of illustration and not limitation. Many changes and modifications within the scope of the present invention may be made without departing from the spirit of the invention, and the present invention encompasses all such modifications.

BRIEF DESCRIPTION OF THE DRAWINGS

Illustrative embodiments of the present disclosure are described herein with reference to the accompanying drawings, in which:

FIG. 1 is an exploded perspective view of an embodiment of a dual-component accommodating IOL.

2 is an exploded side cross-sectional view of the dual-component accommodating IOL of FIG. 1 .

3 is an assembled side view of the two-component accommodating IOL of FIG. 1 , with the power-changing lens and the main lens in sliding contact with each other.

4A-4F are cross-sectional views of various embodiments of dual-component accommodating IOLs.

5 is an exploded perspective view of an embodiment of a dual-component accommodating IOL.

6A and 6B are top and side plan views of the power-varying lens of the dual-component IOL of FIG. 5 .

7A and 7B are top and side plan views of the primary lens of the dual-component IOL of FIG. 5 .

8A and 8B are exploded cross-sectional and coupled cross-sectional views of another embodiment of a two-component accommodating IOL in which the power-varying lens and the main lens are coupled together.

9A and 9B are cross-sectional views of an alternative embodiment of a two-component accommodating IOL in which the power-changing lens and the crystalline lens are coupled together.

10A and 10B are exploded cross-sectional and coupled cross-sectional views of a further embodiment of a two-component accommodating IOL in which the power-varying lens and the primary lens are coupled together.

11A through 11F are top views of various alternative embodiments of the primary lens.

Like numerals refer to like parts throughout the several views of the drawings.

DETAILED DESCRIPTION

Specific non-limiting embodiments of the present invention will be described with reference to the accompanying drawings. It should be understood that such embodiments are provided by way of example and illustrate only a few of the embodiments within the scope of the present invention. Various changes and modifications apparent to those skilled in the art to which the present invention pertains are deemed to be within the spirit, scope, and intention of the present invention as further defined by the appended claims.

1-3 depict an embodiment of a two-component accommodating IOL device 100 in which a power-changing lens 110 and a main lens 120 are in sliding contact with each other.

The variable power lens 110 is depicted as including a fluid- or gel-filled lens chamber 112 and a haptic system 114 disposed about the periphery of the fluid- or gel-filled lens chamber 112. The haptic system 114 includes a peripheral engagement edge 116 configured to engage the capsular bag of the patient's eye, typically where it attaches to the ciliary muscle via the zonules. A plurality of through-holes 115 may be disposed along the periphery of the haptic system 114 to reduce material volume and, therefore, the delivery profile of the variable power lens 110.

The primary lens 120 is depicted as including a fixed power lens 122 and a plurality of centering members 124 disposed symmetrically about the fixed power lens. The centering members 124 include distal edges 126 and through holes 125 to reduce resistance to radial compression applied to the capsular bag.

The presence of aperture 115 within the power lens 110 can allow manipulation of both the power lens 110 and the primary lens 120 thereunder. Aperture 115 also helps reduce the delivery profile of the power lens 110 and allows manipulation of both the power lens 110 and the primary lens 120 to center them within the capsular bag during implantation. The presence of aperture 115 can also reduce the stiffness of the power lens. Similarly, the primary lens 120 also has aperture 125, which allows for manipulation and reduction of the delivery profile. Aperture 125 of the primary lens 120 is additionally shaped to reduce the likelihood of grabbing the power lens 110 when it is implanted in the capsular bag of the patient's eye after the primary lens 120 has been implanted.

The power-varying lens 110 and the primary lens 120 are configured to slide in contact with each other while maintaining a separation between the fluid- or gel-filled lens chamber 112 and the fixed-power lens 122. In one embodiment, this separation is maintained by angling either or both of the haptic system 114 and the centering member 124 toward each other. As shown in Figures 2 and 3, the sliding contact between the power-varying lens 110 and the primary lens 120 is established at the first and second coupling surfaces 118, 128, respectively.

The power-varying lens 110 is sized and shaped to withstand and respond to radially inward forces acting along the peripheral edge 116 of the lens 110. In contrast, the primary lens 120 does not participate in providing an accommodative response and is therefore sized and shaped to avoid interfering with or resisting radial compressive forces acting on the power-varying lens 110. This can be accomplished by controlling the relative diameters and thicknesses of the power-varying lens 110 and the primary lens 120 so as to maximize the extent of radial compressive forces acting on the power-varying lens 110 and minimize the extent of these forces acting on the primary lens 120.

In a preferred embodiment, as depicted in FIG2 , the thickness _t1 of the peripheral articulation edge 116 of the variable power lens 110 is substantially thicker than the thickness _t2 of the distal edge 126 of the fixed power lens 122. In a preferred embodiment, the thickness ratio of _t1 to _t2 is 2:1, preferably 3:1, more preferably 4:1, and most preferably 5:1. In another preferred embodiment, as shown in FIG3 , the diameter _d1 of the variable power lens 110 is greater than the diameter _d2 of the main lens 120.

In a preferred embodiment, at least the opposing sides or walls of the lens chamber 112 are made of a material that has sufficient mechanical strength to withstand physical manipulation during implantation and has a Young's modulus that is low enough to minimize its resistance to deformation. In a preferred embodiment, the opposing sides of the lens chamber 112 are made of a polymer having a Young's modulus of 100 psi or less, preferably 75 psi or less, and most preferably 50 psi or less. In a preferred embodiment, the remainder of the IOL 100 has a Young's modulus that is greater than that of the lens chamber 112. The walls of the lens chamber 112 can be a polymer, preferably a silicone polymer, and more preferably a phenylsiloxane, such as vinyl-terminated phenylsiloxane or vinyl-terminated diphenylsiloxane. To impart sufficient mechanical strength, the polymer can be cross-linked, reinforced, or both with a filler. The filler can be a resin or silica functionalized to react with the polymer.

The walls of the lens chamber 112 define an enclosed cavity that is filled with a fluid or gel having specific physical and chemical properties to enhance the range of refractive power provided by the IOL during accommodation. The fluid or gel is selected so that it cooperates with the power-varying lens 110 to provide a sufficient range of accommodation, up to at least 3 diopters, preferably up to at least 5 diopters, preferably up to at least 10 diopters, and most preferably up to at least 15 diopters. In a preferred embodiment, the enclosed cavity is filled with the fluid or gel prior to implanting the IOL 100 in the capsular bag 40 of the eye, and in a more preferred embodiment, the cavity is filled with the fluid or gel during manufacture of the IOL.

Figures 4A-4F and Figures 8-10 more clearly depict the location of the fluid or gel (213, 313, 413, 513) contained within the power-varying lens (210, 310, 410, 510). In a preferred embodiment, the enclosed cavity defined by the walls of the lens chamber 112 is filled with a fluid, such as a gas or liquid, having a low viscosity at room temperature and a high refractive index. In a preferred embodiment, the fluid (213, 313, 413, 513) is a liquid having a viscosity of 1000 cP or less at 23°C and a refractive index of at least 1.46, 1.47, 1.48, or 1.49. The fluid can be a polymer, preferably a silicone polymer, and more preferably a phenylsiloxane polymer, such as a vinyl-terminated phenylsiloxane or a vinyl-terminated diphenylsiloxane polymer. Preferably, in embodiments where the fluid is made of a polymer, the polymer is preferably not cross-linked and the polymer can be linear or branched. In the case where the fluid is a vinyl terminated phenylsiloxane polymer or a vinyl terminated diphenylsiloxane polymer, the vinyl groups may react to form other groups that do not form crosslinks.

According to one embodiment, the fluid (213, 313, 413, 513) can be polyphenylene ether ("PPE"), as described in U.S. Patent No. 7,256,943, entitled "Variable Focus Liquid-Filled Lens Using PolyphenylEthers," to Teledyne Licensing LLC, the entire contents of which are incorporated herein by reference as if fully set forth herein.

According to another embodiment, the fluid (213, 313, 413, 513) can be a fluoropolyphenylene ether ("FPPE"). FPPE has the unique advantage of providing an adjustable refractive index while being a chemically inert, biocompatible fluid with dispersive properties. Adjustability is provided by increasing or decreasing the phenyl and fluorine content of the polymer. Increasing the phenyl content will effectively increase the refractive index of the FPPE, while increasing the fluorine content will decrease the refractive index of the FPPE while reducing the permeability of the FPPE fluid through the walls of the lens chamber 112.

In another preferred embodiment, the enclosed cavity defined by the walls of the lens chamber 112 is filled with a gel (213, 313, 413, 513). The gel (213, 313, 413, 513) preferably has a refractive index of at least 1.46, 1.47, 1.48, or 1.49. The gel may also preferably have a Young's modulus of 20 psi or less, 10 psi or less, 4 psi or less, 1 psi or less, 0.5 psi or less, 0.25 psi or less, and 0.01 psi or less. In a preferred embodiment, the gel (213, 313, 413, 513) is a cross-linked polymer, preferably a cross-linked silicone polymer, and more preferably a cross-linked phenylsiloxane polymer, such as a vinyl-terminated phenylsiloxane polymer or a vinyl-terminated diphenylsiloxane polymer. In addition to silicone polymers, other optically clear polymer liquids or gels can also be used to fill the closed cavities and such polymers can be branched, unbranched, cross-linked or non-cross-linked or any combination of the foregoing.

Compared to most liquids, gels have the advantages of extended molecular weight cross-linking, greater self-adhesion, and the ability to adhere to the walls or opposing sides of the lens chamber 112. This makes the gel less likely to leak through the walls of the variable power lens. To achieve a combination of adjustable power and relatively small curvature deformation of the variable power lens, the gel (213, 313, 413, 513) is selected to have a high refractive index while being made of an optically transparent material characterized by a low Young's modulus. Thus, in a preferred embodiment, the gel has a refractive index of 1.46 or greater, preferably 1.47 or greater, 1.48 or greater, and most preferably 1.49 or greater. At the same time, the gel preferably has a Young's modulus of 10 psi or less, preferably 5 psi or less, and more preferably 1 psi or less. In a particularly preferred embodiment, the gel has a Young's modulus of 0.5 psi or less, preferably 0.25 psi or less, and most preferably 0.01 psi or less. It will be appreciated that the lower the Young's modulus, the less resistance the gel will exhibit to deformation for a given unit of applied force and therefore the greater the deformation of the power change lens 110 .

In certain preferred embodiments, the gel is a vinyl terminated phenyl siloxane based on one of the following four formulas:

Formula 1:

100 parts of a 20-25 mole % vinyl terminated diphenylsiloxane-dimethylsiloxane copolymer (Gelest PDV 2335).

3ppm platinum complex catalyst

0.35 pph of phenylsiloxane hydride crosslinker (Nusil XL-106)

Young's modulus of elasticity = 0.0033 psi

Formula 2:

100 parts 20-25 mol % vinyl terminated diphenylsiloxane-dimethylsiloxane copolymer (Gelest PDV 2335)

3ppm platinum complex catalyst

0.4 pph of phenylsiloxane hydride crosslinker (Nusil XL-106)

Young's modulus of elasticity = 0.0086 psi

Formula 3:

100 parts 20-25 mol % vinyl terminated diphenylsiloxane-dimethylsiloxane copolymer (Gelest PDV 2335)

3ppm platinum complex catalyst

0.5 pph of phenylsiloxane hydride crosslinker (Nusil XL-106)

Young's modulus of elasticity = 0.0840 psi

Formula 4:

100 parts 20-25 mol % vinyl terminated diphenylsiloxane-dimethylsiloxane copolymer (Gelest PDV 2335)

3ppm platinum complex catalyst

0.6 pph of phenylsiloxane hydride crosslinker (Nusil XL-106)

Young's modulus of elasticity = 2.6 psi

The walls of the lens chamber and the fluid or gel contained within the cavity are preferably selected to prevent or reduce the likelihood of the fluid or gel migrating outside of the lens chamber. Thus, in a preferred embodiment, one or both of the focal-variation lens and the fluid or gel (213, 313, 413, 513) are selected from biocompatible materials that optimize resistance to permeability of the fluid or gel through the focal-variation lens.

One approach to reducing the permeability of the gel contained within the cavity through the focal-variable lens is to provide a crosslinked gel. However, the degree of crosslinking must be selected and controlled so that, on the one hand, the focal-variable lens and the gel have a sufficiently low Young's modulus to minimize resistance to deformation of the focal-variable lens, and, on the other hand, minimize the permeability of the gel through the focal-variable lens. Therefore, in preferred embodiments, longer-chain polymers that are lightly crosslinked, such as those used in silicone gels, are desirable, starting with monomers having a molecular weight greater than 35,000 Daltons, preferably greater than 50,000 Daltons, and most preferably at least 70,000 Daltons.

In another preferred embodiment, a gel having an extract with low permeability is used. Such a gel can be formulated by using long chain polymers containing branches.

In preferred embodiments, one or both of the lens chamber wall and the gel may be made from a homopolymer or copolymer of a phenyl-substituted silicone.

For the lens chamber wall, the crosslinked homopolymer or copolymer preferably has a diphenyl content of 5-25 mol%, preferably 10-20 mol%, and more preferably 15-18 mol%. Alternatively, for the lens chamber wall, the homopolymer or copolymer preferably has a phenyl content of 10-50 mol%, preferably 20-40 mol%, and more preferably 30-36 mol%.

For gels, the homopolymer or copolymer preferably has a diphenyl content of 10-35 mol%, preferably 15-30 mol% and more preferably 25-25 mol%. Alternatively, for gels, the homopolymer or copolymer preferably has a phenyl content of 20-70 mol%, preferably 30-60 mol% and more preferably 40-50 mol%.

In a particularly preferred embodiment, the walls of the lens chambers are made of a cross-linked phenylsiloxane having a diphenyl content of about 15-18 mol % or a phenyl content of about 30-36 mol %, and the gel is made of a phenylsiloxane having a diphenyl content of about 20-25 mol % or a phenyl content of about 40-50 mol %. The walls of the lens chambers are understood to be more cross-linked than the gel.

In certain preferred embodiments, the lens chamber wall is made of vinyl terminated phenylsiloxane, most preferably cross-linked vinyl terminated phenylsiloxane. A reinforcing agent such as silica may also be included in the range of 10-70 mol%, preferably 20-60 mol% and most preferably 30-50 mol%.

The walls of the lens chamber and the fluid or gel contained within the cavity are also preferably selected to increase the range of adjustable focal power provided by the lens chamber. In a preferred embodiment, the walls of the lens chamber are made of a material having a lower refractive index than the fluid or gel contained within the enclosed cavity. In one preferred embodiment, the refractive index of the walls of the lens chamber is 1.38, while the refractive index of the gel or fluid contained therein is 1.49.

The refractive index difference provided by the lens chamber wall and the gel or liquid contained in the lens chamber can be provided by the difference in the materials used for the lens chamber wall and the gel or liquid or the composition of the materials.

In one embodiment, both the lens chamber wall and the gel or liquid are made of phenylsiloxanes having different diphenyl or phenyl contents. In a preferred embodiment, the lens chamber wall has a diphenyl or phenyl content that is lower than that of the gel or liquid. In another preferred embodiment, the lens chamber wall can be made of a cross-linked vinyl-terminated phenylsiloxane having a diphenyl content of approximately 15-18 mol% or a phenyl content of approximately 30-36 mol%, while the gel contained within the lens chamber wall can be made of a vinyl-terminated phenylsiloxane having a diphenyl content of 20-25 mol% or a phenyl content of 30-36 mol%.

In another embodiment, the refractive index difference can be provided by providing diphenylsiloxane to the lens chamber wall, and the gel can be a phenylsiloxane having a high diphenyl or phenyl content. In preferred embodiments, the diphenyl content is at least 20 mol%, at least 25 mol%, at least 30 mol%, at least 35 mol%, and at least 40 mol%. Alternatively, the phenyl content is at least 40 mol%, at least 50 mol%, at least 60 mol%, at least 70 mol%, and at least 80 mol%.

In further embodiments, the refractive index difference can be provided by a cross-linked fluorosilicone, such as 3,3,3-trifluoropropylmethyl siloxane, and the gel can be a phenylsilicone with a high diphenyl or phenyl content. In preferred embodiments, the diphenyl content is at least 20 mol%, at least 25 mol%, at least 30 mol%, at least 35 mol%, and at least 40 mol%. Alternatively, the phenyl content is at least 40 mol%, at least 50 mol%, at least 60 mol%, at least 70 mol%, and at least 80 mol%.

4A-4F depict alternative embodiments of dual-component IOL devices 200A-F in which the shape and configuration of the power-varying lens 210 and the primary lens 230 are varied.

In each of these embodiments, certain features remain the same. A power-varying lens 210 is depicted as including a fluid- or gel-filled lens chamber 212 and a haptic system 214 disposed peripherally of the fluid- or gel-filled lens chamber 212. The lens chamber 212 includes two opposing surfaces divided into a central region 212a, 212b and peripheral regions 211a, 211b about a central axis A-A (see FIG1 ). In a preferred embodiment, the central regions 212a, 212b have a thickness that gradually increases radially from the peripheral regions 211a, 211b toward the center of the lens chamber 212.

In a preferred embodiment, the central point of the central regions 211a, 212b has a thickness that is two or more times, preferably three or more times, and most preferably four or more times, greater than the thickness of the peripheral regions 211a, 211b. A fluid or gel 213 is contained between the opposing surfaces. In another preferred embodiment, the ratio of the point of greatest thickness in the central regions 212a, 212b to the point of least thickness in the peripheral regions 211a, 211b is 2:1 or greater, preferably 3:1 or greater, and most preferably 4:1 or greater. In a preferred embodiment, the thickness at the optical axis or center of the central regions 212a, 212b is approximately 200 microns, while the thickness at the peripheral regions 211a, 211b is approximately 50 microns. Providing increased thickness within the central regions 212a, 212b prevents the opposing surfaces of the lens chamber 212 from bending as the lens chamber 212 deforms in response to accommodation. It will be appreciated that in each embodiment of the power lens depicted in the figures, the opposing sides preferably have thickness profiles as described herein and depicted in Figures 4A-4F. Reference to the optical axis, or optical axis A-A herein, is understood to mean a line that passes through the center of the IOL device, as shown in Figure 1.

The opposing surfaces of the lens chamber 212 actuate toward or away from each other when the eye is unaccommodated and accommodated, respectively. The haptic system 214 includes a peripheral engagement edge 216 and a first coupling surface 218 adjacent the peripheral engagement edge 216. The main lens assembly 230 includes a fixed lens 232 and a plurality of centering members 224 disposed about the fixed lens 232. The centering members 224 include a distal edge 236 and a second contact surface 238 that slides in contact with the first contact surface 218 of the power lens 210.

In a preferred embodiment, the main lens 230 is substantially thicker than one of the opposing sides of the lens chamber 212, as measured along the optical axis A-A. In a preferred embodiment, the thickness of each of the opposing sides of the lens chamber 212 along the optical axis A-A is less than ½, preferably less than ⅓, preferably less than ¼, and most preferably less than ⅕, of the thickness of the main lens 230 at the central optical axis A-A. Because the main lens 230 is substantially thicker than either of the opposing sides of the lens chamber 212, the main lens 230 has an effective Young's modulus that is substantially greater than the effective Young's modulus of either of the opposing sides of the chamber 212.

Turning now to the various distinguishing features of a two-component IOL device, with reference to IOL device 200A in FIG4A , the primary lens 230 is depicted as including a hinge 240 and an angled or square edge 239. Hinge 240 is provided on centering member 224 to allow it to flex axially, compress radially, or both in response to adjustable forces applied to the capsular bag. Thus, hinge 240 allows these adjustable forces to act on the peripheral engagement edge 216 of power-varying lens 210 to actuate opposing surfaces 212 a, 212 b away from or toward each other. Square edge 239 is provided to help secure the primary lens assembly to the capsular bag and may also reduce the likelihood of posterior capsule opacification (PCO) occurring.

4B depicts an IOL device 200B that is similar in many respects to FIG. 4A , except that the hinge 242 provided on the centering member 224 is much wider to provide less resistance to flexion, compression, or both in response to an adjustable force applied to the capsular bag and, therefore, to the distal edge 236 of the centering member 224. It should be understood that for both IOL devices 200A, 200B, the hinge 240 is provided on a surface facing away from the variable power lens 210, and thus, when a radial compressive force is applied to the distal edge 236, the distal edge 236 pivots in a direction away from the variable power lens 210.

4C depicts an IOL device 200C in which the primary lens assembly 230 includes only right-angled edges 239 around the periphery of the fixed lens 232. Because the primary lens assembly 230 does not include a hinge, it is expected that this IOL device 200C will be much stiffer than the IOL devices 200A and 200B depicted in FIGS. 4A and 4B , respectively.

4D depicts an IOL device 200D that is similar to the IOL device 200B in FIG 4B , except that the hinge 244 is now located on the surface facing the power-varying lens 210. Thus, when a radial compressive force is applied to the distal edge 236, the distal edge 236 will pivot in a direction toward the power-varying lens 210.

FIG4E depicts an IOL device 200E having a greater degree of engagement between the variable power lens 210 and the fixed lens assembly 230. The variable power lens 210 and the fixed lens assembly 230 include complementary and interlocking hooks 250, 260 disposed around the periphery of the fluid- or gel-filled lens chamber 212 and the fixed lens 232, respectively. Unlike the IOL devices depicted in FIG4A-4D , the variable power lens 210 and the fixed lens assembly 230 are coupled to each other via the engagement of the interlocking hooks 250, 260.

4F depicts an IOL device 200F in which the power varying lens 210 includes a circumferential protrusion 246 beneath the peripheral engagement edge 216 to constrain movement of the fixed lens component 230 within the boundaries defined by the circumferential portion 246. As a result, it will be appreciated that the fixed lens component 230 has a smaller diameter than the diameter defined by the circumferential protrusion 246.

FIG5-8 depicts another embodiment of a dual-component IOL device 300 in which a variable power lens 310 is constrained within the boundaries of a fixed lens assembly 350. As shown in FIG5-6, the variable power lens 310 has a generally disk-shaped outer surface and includes a closed fluid- or gel-filled lens 312, a haptic system 314, and a circumferential peripheral engagement edge 316. The variable power lens 310 further includes a plurality of circumferential apertures 315 disposed about the periphery of the closed fluid- or gel-filled lens 312. The fluid- or gel-filled lens 312 includes two opposing surfaces divided into central regions 312a, 312b and peripheral regions 311a, 311b. In a preferred embodiment, the central regions 312a, 312b have a thickness that gradually increases radially from the peripheral regions 311a, 311b toward the center of the fluid- or gel-filled lens 312. In a preferred embodiment, the central point of the central regions 312a, 312b has a thickness that is two or more times, preferably three or more times, and most preferably four or more times, greater than the thickness of the peripheral regions 311a, 311b. The fluid or gel 313 is contained between the opposing surfaces. In another preferred embodiment, the ratio of the point of maximum thickness within the central regions 312a, 312b to the point of minimum thickness within the peripheral regions 311a, 311b is 2:1 or greater, preferably 3:1 or greater, and most preferably 4:1 or greater. In a preferred embodiment, the thickness at the optical axis or center of the central regions 312a, 312b is approximately 200 microns, while the thickness at the peripheral regions 311a, 311b is 50 microns. Providing increased thickness within the central regions 312a, 312b prevents the opposing surfaces of the fluid- or gel-filled lens 312 from bending as the fluid- or gel-filled lens 312 deforms in response to accommodation.

The fixed lens assembly 350 is configured to house and receive the power-varying lens 310. The fixed lens assembly 350 includes a centrally disposed fixed lens 352 and an interior cavity defined by the fixed lens 352, a peripheral sidewall 356, and a plurality of radial projections 358 that project inwardly from the top of the peripheral sidewall 356. A circumferential groove or hinge 354 surrounds the fixed lens 352 and allows the peripheral sidewall 356 to pivot or compress radially inward. A plurality of circumferential holes 359 are provided around the periphery of the fixed lens 352 to allow aqueous fluid to flow therethrough and into the cavity 375 (FIG. 8B) defined between the power-varying lens 310 and the fixed lens assembly 350. The holes 359 also reduce the material volume and, therefore, the delivery profile of the fixed lens assembly 350. As shown in FIG. 8B , a space 375 is defined between the power-varying lens 310 and the fixed lens assembly 350 .

The implantation and assembly of the dual-component IOL device 300 follows a two-step process. First, the fixed lens assembly 350 is inserted into the capsular bag of the eye, oriented along the capsular horizontal axis. The fixed lens assembly 350 is centered so that the peripheral sidewall 356 engages the circumferential region of the capsular bag, which is most closely connected to the zonule, and the fixed lens 352 is centered about the optical axis and contacts the posterior portion of the capsular bag. Second, the power-varying lens 310 is inserted into the capsular bag and positioned within the cavity 375 of the fixed lens assembly 350 so that the peripheral engagement edge 316 is proximal to or in contact with the interior surface 360 of the peripheral sidewall 356. Thus, radial compression applied to the peripheral sidewall 356 is transmitted to the peripheral engagement edge 316 of the power-varying lens 310, causing the fluid- or gel-filled lens to increase and decrease curvature in response to relaxation and contraction, respectively, of the eye's ciliary muscles to provide accommodation.

9-10 are cross-sectional views of various embodiments of dual component IOL devices.

9A and 9B are cross-sectional views of two alternative embodiments of dual-component IOL devices 400A and 400B. In both embodiments, the dual-component IOL device includes a variable power lens 410 and a fixed lens assembly 450. The variable power lens 410 includes a fluid- or gel-filled lens chamber 412 defined by opposing surfaces and a fluid or gel 413 confined therein. A haptic 414 having an engaging edge 416 is provided at the periphery of the lens chamber 412. The fixed lens assembly 450 includes a centrally located fixed lens 452 and a hinge 454 disposed at the periphery of the lens 452. Hinge 454 is preferably disposed on the surface of fixed lens assembly 450 that faces power-varying lens 410 such that a radial compressive force applied to circumferential periphery 456 causes it to pivot toward power-varying lens 410 and thereby transmit the radial compressive force to engagement edge 416 of fluid- or gel-filled lens 412 to effect a curvature change on the opposite side of fluid- or gel-filled lens chamber 412. The difference between IOL devices 400A and 400B is that engagement edge 416 in device 400A is in a spaced relationship from interior surface 460 of circumferential periphery 456, whereas engagement edge 416 in device 400B is in contact with interior surface 460 of circumferential periphery 456 when no radial force is applied.

Additionally, the IOL devices 400A, 400B are provided with arcuate surfaces at the points of contact between the power-varying lens 410 and the fixed lens assembly 450 to facilitate sliding movement between the power-varying lens 410 and the fixed lens assembly 450. Thus, in a preferred embodiment, at least the circumferential periphery 456, the articulating edge 416, and the interior surface 460 of the circumferential periphery 456 are arcuate surfaces.

10A and 10B depict another embodiment of a two-component IOL device 500 that includes a power-varying lens 510 and a fixed lens assembly 550. The power-varying lens 510 includes a closed lens chamber 512 defined by two opposing sides that changes curvature in response to a radial force applied to a periphery 516 of a haptic 514.

The two opposing surfaces are divided into a central region 512a, 512b and a peripheral region 511a, 511b. In a preferred embodiment, the central regions 512a, 512b have a thickness that gradually increases radially from the peripheral regions 511a, 511b toward the center of the enclosed lens chamber 512. In a preferred embodiment, the thickness at the center point of the central regions 512a, 512b is two times or more, preferably three times or more, and most preferably four times or more, greater than the thickness of the peripheral regions 511a, 511b. The fluid or gel 213 is confined between the opposing surfaces. In another preferred embodiment, the ratio of the point of maximum thickness within the central regions 512a, 512b to the point of minimum thickness within the peripheral regions 511a, 511b is 2:1 or greater, preferably 3:1 or greater, and most preferably 4:1 or greater. In a preferred embodiment, the thickness at the optical axis or center of the central regions 512a, 512b is approximately 200 microns, while the thickness at the peripheral regions 511a, 511b is approximately 50 microns. Providing increased thickness within the central regions 512a, 512b prevents the opposing surfaces of the enclosing lens chamber 512 from bending as the enclosing lens chamber 512 deforms in response to accommodation. It should be appreciated that in the various embodiments of the power lenses depicted in the figures, the opposing sides preferably have thickness profiles as described herein and depicted in Figures 4A-4F.

The fixed lens assembly 550 includes a fixed lens 552 that does not change shape or curvature. An interior cavity is defined by the fixed lens 552 and a peripheral sidewall 560. A peripheral hinge 554 is provided on the fixed lens assembly 550 at the periphery of the fixed lens 552. The hinge 554 is disposed about the fixed lens 554 and thereby allows the peripheral sidewall 556 to be compressed radially inwardly in the direction of arrow B to compress the variable power lens 510 at the contact periphery 516. This, in turn, causes the opposing sides 512a, 512b to arc away from each other. When radial forces are no longer acting, the fixed lens assembly is resiliently biased to an expanded and unaccommodated state, and the peripheral sidewall expands in the direction indicated by arrow A.

Figures 11A-11F depict various alternative embodiments of fixed lens assemblies 600A-F, which can be used in conjunction with any of the fixed lens assemblies described herein to form a dual-component IOL device of the type described in Figures 1-3. As shown in each of Figures 11A-11F, the haptics 614A-F are arranged symmetrically to ensure centering of the variable power lens. Figure 11A depicts a fixed lens assembly 600A having a lens 612A surrounded by four symmetrically arranged protrusions 614A. Each protrusion includes an orifice 615A and an engagement edge 616A configured to engage the capsular bag of the patient's eye. Figure 11B depicts a similar arrangement of four haptics 614B, except that each haptic has a rounded edge 616B and the haptic pairs point toward each other. Figure 11C depicts an arrangement of four haptics 614C, also having rounded edges 616C, with the haptics pointing in the same direction.

FIG11D depicts a fixed lens assembly 600D comprising a lens 612D and a plurality of haptics 614D, each having an aperture 615D disposed therethrough. The haptics 614D further comprise sized fingers 620 projecting from an outer engagement edge 616D. Implantation of a two-component IOL device generally requires that the fixed lens assembly be implanted first. After the fixed lens assembly is implanted and positioned, the lens capsule wall may compress the engagement edge 616D and displace the sized fingers 620 toward the lens 612D. The extent to which the sized fingers 620 are displaced toward the lens 612D provides an indication of the size of the patient's lens capsule, thereby allowing selection of an appropriately sized variable power lens, which is subsequently implanted within the patient's lens capsule.

1 IE depicts another fixed lens assembly 600E including four haptic projections 614E, each including a triangular-shaped aperture 615E and a peripheral engagement edge 616E. The triangular-shaped apertures 615E are intended to reduce the risk of snags on portions of the power-changing lens during implantation.

1 IF depicts a further embodiment of a fixed lens assembly 600F comprising a lens 612F and three plate haptics 614F protruding from the lens. Because the configuration of the plate haptics 614 provides stiffer haptics, the fixed lens assembly 600F is preferably undersized relative to the lens capsule.

The invention described and claimed herein is not limited in scope to the specific preferred embodiments disclosed herein, as these embodiments are intended to illustrate several aspects of the invention. Indeed, various modifications of the invention in addition to those shown and described herein will be apparent to those skilled in the art upon reviewing the foregoing description. Such modifications are also intended to fall within the scope of the appended claims.

Claims (29)

1. A dual-component adjustable intraocular lens device, i.e., an IOL device, for implantation within a capsular bag of a patient's eye, the IOL device comprising: A master lens assembly including a fixed lens and a centering member disposed around the periphery of the fixed lens, the centering member having a circumferentially distal edge and a first coupling surface adjacent to the circumferentially distal edge; and A diopter-changing lens includes a closed, fluid-filled lens cavity and a tactile system disposed around the lens cavity, the tactile system having a peripheral engagement edge configured to contact the capsule and a second coupling surface facing the first coupling surface and positioned adjacent to the peripheral engagement edge. The first and second coupling surfaces are in sliding contact with each other to allow the solubility-changing lens to move relative to the main lens assembly; and The first and second coupling surfaces maintain the spacing relationship between the fixed lens and the lens cavity when the lens with varying focal length is radially compressed. 2. The dual-component adjustable intraocular lens device according to claim 1, wherein the diameter _d1 of the diopter-changing lens is greater than the diameter _d2 of the main lens assembly when there is no radial compression. 3. The dual-component adjustable intraocular lens device according to claim 1, wherein the fixed lens does not change shape or curvature during adjustment. 4. The dual-component adjustable intraocular lens device of claim 1, wherein the lens cavity changes both its shape and curvature during adjustment. 5. The dual-component adjustable intraocular lens device according to claim 1, wherein the fixed lens and the lens cavity are positive focal lenses. 6. The dual-component adjustable intraocular lens device according to claim 1, wherein the fluid-filled lens cavity is a biconvex lens. 7. The dual-component adjustable intraocular lens device of claim 1, wherein the fixed lens assembly includes a right-angled edge circumferentially positioned around the outer side of the optical zone of the fixed lens. 8. The dual-component adjustable intraocular lens device according to claim 1, wherein the centering member and the facing surfaces of the tactile system each include one of a complementary and interlocking pair, the interlocking pair being arranged circumferentially around the fixed lens and the focal length-changing lens, respectively. 9. The dual-component adjustable intraocular lens device of claim 1, wherein the peripheral engagement edge is thicker than the circumferential distal edge. 10. The dual-component adjustable intraocular lens device of claim 9, wherein the thickness ratio of the circumferential distal edge to the peripheral engagement edge ranges from 1:5 to 1:2. 11. The dual-component adjustable intraocular lens device of claim 1, wherein the primary lens assembly has a higher Young's modulus than the diopter-changing lens. 12. The dual-component adjustable intraocular lens device of claim 1, wherein at least one of the centering member and the tactile system includes a plurality of openings. 13. The dual-component adjustable intraocular lens device of claim 1, wherein the main lens includes a sizing device that provides an approximation of the diameter of the capsule. 14. The dual-component adjustable intraocular lens device of claim 13, wherein the sized device is one or more radial extensions. 15. The dual-component adjustable intraocular lens device of claim 1, wherein the diopter-changing lens comprises two opposing surfaces that are displaced away from each other when a radial force is applied along the peripheral edge, the two opposing surfaces having a central region and a peripheral region and having a thickness profile that gradually increases from the peripheral region to the central region. 16. The dual-component adjustable intraocular lens device according to claim 1, wherein the fluid-filled lens cavity is a gel-filled lens cavity. 17. A dual-component adjustable intraocular lens device, i.e., an IOL device, for implantation within a capsular bag of a patient's eye, the IOL device comprising: A master lens assembly includes a fixed lens and a centering member disposed around the periphery of the fixed lens, the centering member having a radially compressible peripheral edge, the peripheral edge having an outer circumferential surface configured to engage the capsular bag of the patient's eye and an inner circumferential surface radially inwardly spaced from the outer circumferential surface; A lens with variable focal length, comprising an enclosed, fluid-filled lens cavity and a tactile system disposed around the periphery of the lens cavity, the tactile system having circumferential edges configured to engage the internal circumferential surface; and A cavity defined between the main lens assembly and the diopter-changing lens and configured to allow aqueous humor to flow in; The radial compression acting on the outer circumferential surface causes at least one of an increase in the curvature and a decrease in the diameter of the lens cavity. 18. The dual-component adjustable intraocular lens device of claim 17, wherein the centering member further comprises a circumferential hinge between the fixed lens and the peripheral edge, the circumferential hinge being disposed on opposite sides of the centering member. 19. The dual-component adjustable intraocular lens device of claim 17, wherein the centering member further comprises a single circumferential hinge between the fixed lens and the peripheral edge. 20. The dual-component adjustable intraocular lens device of claim 19, wherein the circumferential hinge is disposed on the internal surface of the tactile system facing the focal length-changing lens. 21. The dual-component adjustable intraocular lens device of claim 19, wherein the inner circumferential surfaces of the circumferential edge and the peripheral edge of the tactile system have complementary circular surfaces, and wherein radial compression acting on the outer circumferential surface causes the peripheral edge to tilt radially inward about the circumferential hinge. 22. The dual-component adjustable intraocular lens device of claim 17, wherein the diopter-changing lens is completely contained within the peripheral edge of the main lens assembly. 23. The dual-component adjustable intraocular lens device of claim 22, further comprising a circumferential flange disposed radially inward from the inner surface of the circumferential edge. 24. The dual-component adjustable intraocular lens device of claim 17, wherein the main lens includes a sizing device that provides an approximation of the diameter of the capsule. 25. The dual-component adjustable intraocular lens device of claim 17, wherein the diopter-changing lens comprises two opposing surfaces that are displaced away from each other when a radial force is applied along the peripheral edge, the two opposing surfaces having a central region and a peripheral region, the thickness of the central region being at least twice the thickness of the peripheral region. 26. The dual-component adjustable intraocular lens device of claim 17, wherein the diopter-changing lens comprises two opposing surfaces that are displaced away from each other when a radial force is applied along the peripheral edge, the two opposing surfaces having a central region and a peripheral region, the thickness of the central region being at least three times the thickness of the peripheral region. 27. The dual-component adjustable intraocular lens device of claim 17, wherein the diopter-changing lens comprises two opposing surfaces that are displaced away from each other when a radial force is applied along the peripheral edge, the two opposing surfaces having a central region and a peripheral region, the thickness of the central region being at least four times the thickness of the peripheral region. 28. The dual-component adjustable intraocular lens device of claim 17, wherein radial compression acting on the outer circumferential surface does not cause an increase in the curvature or a decrease in the diameter of the fixed lens. 29. The dual-component adjustable intraocular lens device of claim 17, wherein the fluid-filled lens cavity is a gel-filled lens cavity.