Hydrophilic AIOL with bonding

Abstract

An accommodating intraocular lens comprises a first lens component, a second lens component, and an adhesive between portions of the two lens components. The cured adhesive bonds the lens components to form a fluid chamber. The lens components are bonded to one another along a seam which extends circumferentially along at least a portion of the lens components. The lens components may comprise the same polymer material. The cured adhesive also comprises the polymer or a prepolymer of the polymer to provide increased strength. The polymer is hydratable such that the lens components and the cured adhesive therebetween can swell together to inhibit stresses between the lens components and the cured adhesive.

Claims

1. An accommodating intraocular lens, comprising: an annular lens support having an outer edge defining an outer periphery of the accommodating intraocular lens and surrounding an optical axis of the accommodating intraocular lens; a non-deflectable lens coupled to the annular lens support; a deflectable lens coupled to the annular lens support and spaced apart from the non-deflectable lens; and a fluid filled chamber between the non-deflectable lens and the deflectable lens, wherein the chamber is an enclosed volume within the accommodating intraocular lens; wherein the annular lens support has an anterior-most portion and a posterior-most portion; wherein the entire non-deflectable lens is positioned between the anterior-most portion and the posterior-most portion of the annular lens support when the annular lens support is in an uncompressed configuration; and wherein the non-deflectable lens is configured to displace along the optical axis and the deflectable lens is configured to change in curvature about the optical axis when compressive force is applied to the annular lens support.

2. The intraocular lens of claim 1, further comprising a concave region extending circumferentially around the deflectable lens between the deflectable lens and the annular lens support, wherein the concave region transmits force applied to the annular lens support to the deflectable lens.

3. The intraocular lens of claim 1 wherein the fluid in the fluid filled chamber comprises saline, a non-ionic solution, and/or silicone oil.

4. The intraocular lens of claim 3 wherein the non-ionic solution comprises dextran.

5. The intraocular lens of claim 1, further comprising a concave region extending circumferentially around the deflectable lens, wherein the annular lens support comprises a haptic structure surrounding the concave region.

6. The intraocular lens of claim 1 wherein the deflectable lens is located at a position anterior to the non-deflectable lens.

7. The intraocular lens of claim 1, further comprising a step at a radially outward perimeter of the non-deflectable lens.

8. The intraocular lens of claim 1 wherein a posterior surface of the non-deflectable lens is convex.

9. The intraocular lens of claim 1 wherein a central thickness of the combined deflectable lens and the non-deflectable lens, as measured along a central axis of the deflectable lens and the non-deflectable lens, decreases in a far vision configuration and increases in a near vision configuration.

10. The intraocular lens of claim 1 wherein an optical power of the fluid filled chamber increases when the curvature of the deflectable lens is increased.

11. The intraocular lens of claim 1 wherein the non-deflectable lens is displaced axially and the deflectable lens changes in curvature about the optical axis when radially compressive force is applied to the annular lens support.

12. The intraocular lens of claim 1, wherein the deflectable lens and the non-deflectable lens translate together in a first direction along the optical axis in response to radial compressive force on the annular lens support.

13. The intraocular lens of claim 12, wherein the first direction is an anterior direction.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

(1) The novel features of the disclosure are set forth with particularity in the appended claims. A better understanding of the features and advantages of the present disclosure will be obtained by reference to the following detailed description that sets forth illustrative embodiments, in which the principles of the disclosure are utilized, and the accompanying drawings of which:

(2) FIG. 1 illustrates a perspective view of an accommodating intra ocular lens system, in accordance with many embodiments;

(3) FIG. 2 illustrates a side view of a lens support structure and lens, in accordance with many embodiments;

(4) FIG. 3 illustrates a sectioned view of a lens support structure incorporating a lens interfaced using threads, in accordance with many embodiments;

(5) FIG. 4 illustrates a sectioned view of a lens support structure incorporating a lens interfaced using an interference fit, in accordance with embodiments;

(6) FIG. 5 illustrates a perspective view of an alternative accommodating intra ocular lens system, in accordance with many embodiments;

(7) FIG. 6 illustrates a sectioned view of an alternative accommodating intra ocular lens system, in accordance with many embodiments;

(8) FIG. 7 illustrates a sectioned view of an alternative accommodating intra ocular lens system, in accordance with many embodiments;

(9) FIG. 8 illustrates a sectioned view of an alternative accommodating intra ocular lens system, in accordance with many embodiments;

(10) FIG. 9 shows a perspective view of a support structure for the AIOL of FIG. 8, in accordance with alternate embodiments of the AIOL of FIG. 8;

(11) FIG. 10 shows a method of manufacturing an AIOL, in accordance with many embodiments; and

(12) FIG. 11 shows an optical structure deformed to provide optical power.

DETAILED DESCRIPTION

(13) In many embodiments, an accommodating intra ocular lens system (AIOL) comprises a central structure comprising two deformable lenses spaced apart along their optical axis by an outer support structure concentric with the optical axis of the lenses. The volume bounded by the lenses and the outer support structure may be filled with a fluid, such as an ionic solution (saline). Alternatively or in combination, other fluids can be used such as oil, silicone oil, or solutions comprising high molecular weight molecules such as high molecular weight dextran solution, for example. In such solutions of high molecular weight materials, the solute may increase the refractive index while the high molecular weight of the solute may inhibit the diffusion of the solute from the inner chamber. The outer support structure in turn may be bounded by one or more fluid filled haptics arranged in a plane normal to the optical axis of the lenses. The haptics may be in fluid communication with the fluid bounded by the inner support structure. The transfer of fluid between the haptics and the fluid filled support structure may change the accommodating power of the lens system. The system as described herein may additionally comprise any or any combination of the following features:

(14) A reduced delivery cross section is facilitated by an internal support structure capable of translating from a delivery configuration to an operational configuration. The inner support structure may have a small dimension along the optical axis in the delivery configuration and larger dimension along the optical axis in operational configuration. The inner support structure may be designed to maintain the distance between the periphery of the two lenses in the operational configuration and to allow fluid to pass between the haptics and the volume bounded by the internal support structure.

(15) The delivery cross section can be attained by folding or rolling the AIOL around a delivery axis normal to the optical axis. The delivery cross section may be measured as the largest dimension in the delivery configuration measured in a plane normal to the delivery axis. Delivery cross sections attainable for the AIOLS described herein may be less than 4.5 mm, and preferably less than 2.5 mm.

(16) The lens system may comprise of at least two hydrophilic PMMA lenses, and may include other elements comprising any or any combination of the following materials: NiTi, poly urethane, hydrophilic PMMA, photo activated polymers, precursors to PMMA, poly(hydroxy ethyl) methacrylate (PHEMA), copolymers of polymethyl methacrylate and PHEMA, and Ethylene glycol dimethylacrylate.

(17) In some embodiments, the internal support structure comprises a material which is changed from a delivery configuration to an operation configuration after introduction into the capsule of the eye. One such material comprises a photo active polymer which in the delivery configuration may be a liquid which can be hardened by photo activation after introduction. Another such material comprises a memory metal such as an NiTi alloy which in the delivery configuration may have a thin dimension in a plane normal to the optical axis and after introduction may be initiated to change to an operational configuration by heating via inductive coupling or body heat, alternatively or in combination.

(18) The internal support structure in some embodiments is mechanically more stable in the operational configuration than in the delivery configuration, and spontaneously changes from a delivery configuration to an operational configuration after introduction into the capsule of the eye. In such a configuration the internal support structure may be coaxed into a delivery configuration just prior to delivery or at manufacture.

(19) One such system comprises a super elastic metal element which springs from the delivery configuration upon introduction of the device into the capsule.

(20) In some embodiments, the inner support structure and one lens are machined or molded as a single structure and the second lens is affixed to the support structure by an alternate means. Alternate means include mechanical interfaces such as threading where the outer periphery of the lens is threaded and the inner surface of the support structure is threaded. In an alternate embodiment, the interface can be a simple interference fit. In some embodiments, affixing comprises bonding the materials by treating the one or both of the separate bonding surfaces with a precursor monomer, then assembling the structure, applying a load across the bonding surfaces, and heating the assembly for a period of time.

(21) In the devices of the present disclosure, the lenses may comprise a water and ion permeable material. In some embodiments, the AIOL is allowed to self fill after implantation, thereby minimizing the delivery cross section.

(22) In an alternate embodiment, the AIOL is filled after implant.

(23) The lenses and some of the support structures described herein are fabricated from a hydrophilic material such as a copolymer of hydroxyethyl methacrylate and methyl methacrylate such as CI18, CI21, or CI26 produced by Contamac Ltd. of the UK. These materials are optically clear when hydrated, swell on hydration by more than 10% (for example, by 10-15%), and accommodate strain levels of greater than 100% when hydrated. When fully hydrated, these materials may have a water content of 15 to 30%. For example, CI18 when fully hydrated may be composed of 18% water, CI21 when fully hydrated may be composed of 21% water, and CI26 when fully hydrated may be composed of 26% water. In a substantially dry state or configuration, these materials may be have a water content of no more than about 5%, for example 0.2-3%. These materials are often oven dried prior to machining

(24) FIG. 1 illustrates an accommodating intraocular lens system 10 which may comprise a central lens support structure 11, two haptics 12, two deformable lenses 13 of which only one is visible in the figure, and two compression bands 14. The haptics may comprise thin walled structures configured to deform under minimal loads and comprise an elastomeric material. The internal volume of the AIOL can be filled with a clear fluid such as saline of comparable osmolality to that of the fluids in the eye around the lens capsule. The lenses 13 may be interfaced to the support structure 11 such that as fluid transfers from the haptics into the internal volume of the support structure the lenses are caused to deform thereby changing their accommodative power. A side view of the lens support structure 11 of FIG. 1 along with two lenses 13 is illustrated in FIG. 2. Also visible in FIG. 2 are the haptic interface features 15 comprised in the lens support structure 11. The open end of the haptics 12 may fit over the haptic interface features 15 and may be further affixed to the lens support structure interface feature 15 using compression bands 14. Additionally, in some embodiments, an adhesive or sealant may be used. The distance between the periphery of the lens can be maintained by the support structure while the centre of the lens may be allowed to deform as the fluid volume within the support structure increases, thereby changing the accommodative power of the structure.

(25) FIG. 3 illustrates a lens support structure in which one of the two lenses, lens 36 is comprised in the support structure. The second lens in the embodiment of FIG. 3 may be designed to interface to the support structure via threads 37. Another embodiment for a central support structure similar to that of FIG. 3 is illustrated in FIG. 4. In this embodiment, the second lens 43 may be interfaced via an interference fit. In some embodiment, the interference fit may be further sealed through the use of a sealant or adhesive. The interference fit may be further facilitated by the procedure used to assemble and rehydrate the components. One such procedure as implemented on the structure of FIG. 4 may be as follows: the bottom of the support structure 41 comprising lens 46 may be hydrated, the lens 43 in the unhydrated condition can then be fitted into the groove comprised in the support structure 41, the support structure and lenses may be allowed to completely hydrate, and, if required, a sealant or adhesive may then be applied. The use of interference fits can minimize the requirement and or amount of bonding agent.

(26) FIG. 5 illustrates another embodiment of an AIOL 50 in which half of the support structure 41 and haptics 42 may be comprised in an upper and lower half of the AIOL 50 and thereby all fabricated from the same material. The two halves may be bonded together at seam 59 to form the complete haptic and support structure. Lens 53 may either be integral to the half structures as or bonded to the support structure. In the manufacturing environment allowing one lens to be aligned and bonded after the fabrication of the rest of the structure provides advantage in assuring the optical axis of the two lenses are precisely aligned.

(27) In the embodiments of FIGS. 1 and 2, the haptics are configured in such a fashion that they may be folded out and away from the support structure in a plane normal to the optical axis of the lenses. Such a configuration may facilitate a reduction in delivery cross section for a fluid filled device. In the embodiment of FIG. 6 through 7, the haptics may be both integral to the support structure and attached continuously around the perimeter of the support structure.

(28) FIG. 6 illustrates an embodiment of an AIOL 60 wherein the haptic 62 and the support structure 61 are integral and are configured as a toroid like structure. The inner radius of the structure comprises the support structure 61. Fluid may be allowed to flow between the haptic 62 and the inner volume of the support structure 61 through openings 67. The AIOL 60 can be fabricated by bonding the two halve at seam 59. Lens 63 may be integral with the halves are bonded separately to the halves.

(29) A variation on the embodiment of FIG. 6 is illustrated in FIG. 7. The embodiment of the AIOL 70 may incorporate features which help to reduce the delivery cross section. Half of the support structure may be comprised on each the upper and lower halves on the AIOL 70 and comprises a series of structures 71 each separated by as space forming a castellated ring. Castellated structures can be meshed at assembly prior to bonding at seam 79. Spring ring 79 may fit in a grove and may lock the upper and lower halves of the structure relative to displacements along the optical axis. As shown in FIG. 7, the lenses 73 can be integral to the half structures comprising the AIOL 70. In other embodiments, the lenses 73 may be separate and bonded at another time. In such an embodiment, the support structure is capable of greater deformation during delivery as the castellated elements can fold over a greater radius of curvature. AIOL 70 also comprises feature 78, which allows for a means of applying pressure directly across seam 79 during the bonding process.

(30) FIG. 8 represents an embodiment of an AIOL 80 which comprises an elastomeric support structure 81 filled with a fluid capable of being hardened after delivery of the AIOL. Such fluids may be optically cured, such as a UV curing silicone or epoxy, pH cured such as a collagen solution, or heat cured where the material contains a suspension of particle capable of being inductively heated such as magnitite particles. Channels 87 may allow fluid to pass between the haptic and the central volume of the support structure.

(31) FIG. 9 shows a support structure 81 in accordance with an alternate embodiment of AIOL 80. The support structure 81 may be replaced with a support structure 91 which comprises a memory metal which can be flattened prior to assemble then headed by inductive coupling allow it to take an operation configuration after delivery, such a configuration provides for a reduced cross section.

(32) Embodiments described herein also allow for sequencing the assembly and the use of long setting, heat, pressure, and or optical initiated bonding materials to insure proper optical alignment of the lenses.

(33) Bonding

(34) Bonding can be used to bond one or more of many AIOL structures as disclosed herein.

(35) Bonding of a copolymer of hydroxyethyl methacrylate and methyl methacrylate may be facilitated by treating the bond surfaces with an Ethylene glycol dimethylacrylate or Ethylene glycol trimethylacrylate. Then, the bonded surfaces may be subjected to pressure and temperature. Treatment may include but is not limited to vapor treatment, wetting, wetting and allowing for evaporation, applying a mixture of Ethylene glycol dimethylacrylate or Ethylene glycol trimethylacrylate and particles of a copolymer of hydroxyethyl methacrylate and methyl methacrylate.

(36) Such a bonding scheme can provide advantage in that there is no or minimal seamthe bonded interface has the same mechanical properties as the structure.

(37) Each of the components can be provided in a stiff configuration for machining and bonded together with the adhesive while in a stiff configuration. The component can be subsequently hydrated.

(38) The prepolymer of the adhesive may comprise one or more of Ethylene glycol dimethylacrylate or Ethylene glycol trimethylacrylate, and the prepolymer can be cured to bond the first and second components together. The precursor monomers may be partially or fully polymerized by the addition of an initiator. The initiator may be a photoinitiator such as Irgacure 651 (I651,Ciba-Geigy), or an initiator such as 2,2-azobis(isobutyonitrile), 2,2-azobis(2,4-dimethylvaleronitrile), dilauroyl peroxide and bis(4-t-butylcyclohexyl)peroxydicarbonate, for example.

(39) In many embodiments, the first and second lens components comprise a copolymer of hydroxyethyl methacrylate and methyl methacrylate. When cured, the adhesive comprises the copolymer of hydroxyethyl methacrylate and methyl methacrylate. This configuration can allow the lens to expand from a stiff less than fully hydrated configuration, to the fully hydrated configuration with substantially swelling and inhibited stress to the components and the adhesive located along the seam. The stiff, less than fully hydrated configuration of the polymer material will be understood by a person of ordinary skill in the art to comprise a polymer having a sufficiently low amount of water to provide stiffness to the polymer material of the first and second components. The less than fully hydrated configuration may comprise a substantially dry configuration composed of no more than about 5% water, for example 0.2-3% water, such that the polymer material comprises sufficient stiffness for machining the material to optical tolerances as will be readily understood by a person of ordinary skill in the art. When the AIOL is placed in the lens capsule or placed in a hydration buffer as understood by a person of ordinary skill in the art, for example, the polymer may swell to a hydrated state and gradually to a fully hydrated state. The polymer in the fully hydrated state may be composed of about 15% to 30% water, for example, depending on the material selected. The polymer in the fully hydrated state may swell by more than 10%, such as 10% to 15%.

(40) FIG. 10 shows a method 1000 of manufacturing and providing an AIOL.

(41) At a step 1010, a block of polymer material as described herein is provided. The block of material is cut into a first component 1012 and a second component 1014. The polymer material comprises a stiff configuration as described herein.

(42) At a step 1020, the first component 1012 and the second component 1014 are shaped into first lens component 1022 and second lens component 1024 of the AIOL. The components can be shaped in one or more of many ways such as turning on a lathe, cutting, ablation, and other known methods of shaping optical lenses. Alternatively or in combination, the components may be molded. One or more of the components 1022, 1024 comprises a feature 1026 shaped to receive the opposing component (the feature 1026 may comprise an annular groove, for example). A channel 1028 can be provided to allow fluidic communication with the chamber 1036 of the AIOL. Alternatively or in combination, the channel 1028 can be formed when the first and second components are bonded together.

(43) At a step 1030, the first and second components 1022, 1024 are bonded together with an adhesive 1032 provided in the feature 1026. The first component 1022 and the second component 1024 define a chamber 1036.

(44) The adhesive 1032 comprises a prepolymer of the polymer of the components 1012 and 1014. Although the components are shown provided from a single block, the polymer material can be provided with separate blocks of material having similar polymer composition.

(45) A haptic 1038 can be affixed to the AIOL 1035, such that an internal chamber of the IOL is fluidically coupled to the chamber of the haptic. The haptic may comprise a material similar to the AIOL, or a different material. The haptic 1038 may have a thickness 1039. For example, the AIOL may comprise an acrylate as described herein and the haptic 1038 may comprise a soft silicon material. The haptic may comprise a soft material inserted into the AIOL when the AIOL comprises a stiff configuration, for example.

(46) The AIOL in the stiff configuration comprises a dimension 1034 across, such as a diameter. The AIOL may comprise a thickness 1048 extending between an anterior most portion of the AIOL body and the posterior most portion of the AIOL body.

(47) At a step 1040, the AIOL 1035 is hydrated to a substantially hydrated configuration to decrease stiffness, such that the AIOL comprises a soft material. In the hydrated configuration dimensions of the AIOL increase, and may increase proportionally to each other. In many embodiments, the increase comprises a similar percentage increase along each dimension.

(48) In many embodiments, the amount of hydration in the stiff configuration comprises a predetermined amount of hydration in order to accurately machine the lens components to an appropriate amount of refractive power when the AIOL comprises the fully hydrated state when implanted in the eye.

(49) The disc shaped optical structure of the upper component 1022 can be flat, or lens shaped, for example. The disc shaped optical structure of the lower component 1022 can be flat, or lens shaped, for example, such that one or more of the optical structures deforms to provide optical power.

(50) FIG. 11 shows one or more of the optical structure deformed to provide optical power with a curved surface 1100. The fluid of the AIOL can be greater than the index of refraction of 1.33 of the aqueous humor in order to provide the increased optical power with curved surface 1100.

(51) While reference is made to acrylates, the polymer and prepolymer may comprise silicone hydrogel materials, for example.

(52) While preferred embodiments of the present disclosure have been shown and described herein, it will be obvious to those skilled in the art that such embodiments are provided by way of example only. Numerous variations, changes, and substitutions will now occur to those skilled in the art without departing from the disclosure. It should be understood that various alternatives to the embodiments of the disclosure described herein may be employed in practicing the inventions of the disclosure. It is intended that the following claims define the scope of invention and that methods and structures within the scope of these claims and their equivalents be covered thereby.