WO2026019487A1

WO2026019487A1 - Intraocular lenses and methods of manufacture thereof

Info

Publication number: WO2026019487A1
Application number: PCT/US2025/031648
Authority: WO
Inventors: Malik Y. Kahook
Original assignee: University of Colorado System; University of Colorado Colorado Springs
Current assignee: University of Colorado System; University of Colorado Colorado Springs
Priority date: 2024-07-18
Filing date: 2025-05-30
Publication date: 2026-01-22
Anticipated expiration: 2027-01-18

Abstract

Disclosed herein is an intraocular lens comprising a central lens; and a plurality of peripheral reservoirs in fluid communication with the central lens; wherein a liquid is transported from at least some of the plurality of peripheral reservoirs to the central lens and from the central lens to at least some of the plurality of peripheral reservoirs without a change in a volume of the central lens.

Description

INTRAOCULAR LENSES AND METHODS OF MANUFACTURE THEREOF

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of U.S. provisional patent application no. 63/672,880, filed July 18, 2024, the disclosure of which is hereby incorporated by reference as if set forth in its entirety herein.

BACKGROUND

[0002] This disclosure relates to intraocular lenses and to methods of manufacture thereof. In particular, this disclosure relates to lenses with modifiable refractive indices to shift the focal length after implantation. The disclosure also relates to accommodating lenses that are used in cataract surgery and other vision correction procedures to replace the eye's natural lens.

[0003] In treating a cataract, the surgeon removes the crystalline lens matrix from the lens capsule and replaces it with an intraocular lens (“IOL”) implant. The typical IOL provides a selected focal length that allows the patient to see at a distance without assistance of glasses or other vision correction methods, such as contact lenses. The surgeon selects the power of the IOL based on analysis of refractive characteristics of the patient's eye prior to the surgery. However, in a significant number of cases, after the patient's eye has healed from the cataract surgery, there is a residual refractive error that could not be predicted in advance. It is quite common for residual errors after IOL implantation to occur, and in fact, such errors may occur in the vast majority of IOL patients. This error reportedly averages approximately 0.6 diopters, with a +/- 0.5 standard deviation. Thus, many patients experience an error of over +/- 1.0 diopter.

[0004] The erroneous IOL may be removed and a new IOL selected and implanted. In some cases, cornea based laser surgery is used to correct the residual refractive error. However, performing additional ophthalmic surgeries for this purpose is undesirable. Other IOLS may have their power adjusted noninvasively. For example, the IOL may be sensitive to ultraviolet (UV) light. Such an IOL may be exposed to UV light in order to change the power of the lens. The exposure to UV light may change the shape or the refractive index of the IOL and, therefore, the base power of the lens. Although this method allows the base power of the IOL to be adjusted, such an IOL requires the patient to wear UV light blocking glasses at all times until an adjustment phase is completed. The adjustment phase is typically on the order of two to three weeks. Requiring a patient to wear UV light blocking glasses twenty-four hours per day for weeks is inconvenient for the patient and undesirable. Once the adjustment phase is completed, the changes to the IOL must be locked in to prevent further changes to the IOL power due to every day exposure to UV light. Once these changes are locked in, no further adjustments may be made to the base power of the IOL. It is noteworthy that the eye continues to change from a refractive standpoint throughout the age of any given patient, and a lens implanted at one timepoint may not provide the needed refractive correction in the future as the eye changes over time. Other mechanisms, such as a change in tension, exist to change the base power of the lens. However, these mechanisms have attendant issues shortcomings.

[0005] Accordingly, what is needed is an improved mechanism for noninvasively changing the base power of an IOL.

SUMMARY

[0006] Disclosed herein is an intraocular lens comprising a central lens; and a plurality of peripheral reservoirs in fluid communication with the central lens; wherein a liquid is transported from at least some of the plurality of peripheral reservoirs to the central lens and from the central lens to at least some of the plurality of peripheral reservoirs without a change in a volume of the central lens.

[0007] Disclosed herein too is an intraocular lens comprising a central lens; and a plurality of peripheral reservoirs in fluid communication with the central lens; wherein a liquid is transported from at least some of the plurality of peripheral reservoirs to the central lens causing a change in a volume of the central lens and changing the focusing power of the central lens.

[0008] Disclosed herein too is a method of using an intraocular lens, the method comprising disposing the intraocular lens in the lens capsule of a patient’s eye; where the intraocular lens comprises a central lens; and a plurality of peripheral reservoirs in fluid communication with the central lens; and transporting a liquid from at least some of the plurality of peripheral reservoirs to the central lens and from the central lens to at least some of the plurality of peripheral reservoirs.

BRIEF DESCRIPTION OF THE FIGURES

[0009] FIG. 1 is a depiction of a top view of an exemplary intraocular lens;

[0010] FIG. 2 is a depiction of an exemplary embodiment of the section AA’ from FIG. 1;

[0011] FIG. 3 is a depiction of another exemplary embodiment of the section AA’ from FIG. 1;

[0012] FIG. 4 is a depiction of another exemplary embodiment of the section AA’ from FIG. 1; and

[0013] FIG. 5 is a depiction of another exemplary embodiment of the section AA’ from FIG. 1.

DETAILED DESCRIPTION

Definitions

[0014] Accommodating intraocular lenses (IOLS) are a type of lens implant used in cataract surgery and other vision correction procedures to replace the eye's natural lens. Accommodating IOLs change the focusing power of the lens by changing the thickness and curvature of the lens.

[0015] A non-accommodating lens is a type of lens implant that does not change shape, volume or position to adjust focus between near and distant objects. Unlike the natural crystalline lens of the eye, which can change its shape to focus (a process known as accommodation), a non-accommodating 1OL remains fixed in shape and position once implanted.

Detailed Description

[0016] Disclosed herein is an IOL that comprises a central lens that is in contact with peripheral liquid reservoirs. The central lens comprises a central optical zone that includes the visual axis of the eye and outside a peripheral zone that lies outside the eye’s visual axis. Disposed in the peripheral zone lie a plurality of peripheral liquid reservoirs, each of which contain a liquid that may be used to adjust the refractive index of the central lens. The peripheral reservoirs are in direct fluid communication with the central lens. In an embodiment, liquid is transported from at least some of the plurality of peripheral reservoirs to the central lens and from the central lens to at least some of the plurality of peripheral reservoirs without a change in volume of the central lens. The combination of two different refractive indices

(and thus refractive surfaces), one from the liquid in the central lens and one from the outer surface material (e.g., the lens skin) in which the liquid of the central lens is encompassed, has the advantage of enhancing the balance of depth of focus and depth of field profiles (when there is a difference between the two refractive indices) for the overall optical functionality of the IOL. The outer surface material in which the central liquid is contained can also feature optical surfaces that lead to multifocality or other optical light focusing profiles (e.g. enhanced depth of focus, monofocality, toricity, and the like).

[0017] The IOL has a non-accommodating feature and/or an accommodating feature. In other words, the IOL may be operated in a non-accommodating mode or in an accommodating mode. In the non-accommodating feature, liquids from these peripheral reservoirs may be transported to the central lens and back to the peripheral reservoirs when it is desired to change the refractive index of the central lens. The liquid flow is therefore bi-directional. In the non-accommodating feature, the peripheral reservoirs are gated or closed off from the central lens, and the sole purpose of the reservoirs is to be opened to alter the refractive index of the central lens. In the non-accommodating mode, there is no change in the volume or thickness of the central lens.

[0018] In the accommodating feature, a different set of peripheral reservoirs are always in direct open communication with the central lens. These open peripheral reservoirs are either compressed or decompressed to allow for shifting of a volume of liquid in or out of the central lens to change the thickness (and hence the curvature) of the central lens and thus the focusing power of the lens. The two different kinds of peripheral reservoirs (e.g., those that are walled-off from the central lens and used primarily for effecting a refractive index change in the IOL and those that are in continual direct contact with the central lens and used to effect a volume change in the central lens) might coexist in the same IOL, allowing for both static correction of refractive power of the lens (non-accommodating change) as well as kinetic change (accommodating) in the thickness of the lens, depending on which reservoirs) are being “influenced".

[0019] In an embodiment, the liquid movement from the central lens to the peripheral reservoirs are influenced by body temperature and ocular pulsations. This liquid movement can be enhanced by increasing eye temperature through external application of heat (using lasers, warm/hot compresses, or by other means). The liquid movement can also be enhanced by external application of pulsations via ultrasonic or other mechanical forces. In an embodiment, liquid transport from one compartment to another involves a change in overall chromophore concentration to increase or decrease chromatic aberrations.

[0020] In an embodiment, the central lens thickness is unchanged when modifying the refractive index. In another embodiment, the central lens thickness is changed while the refractive index is also simultaneously modified. In another embodiment, the central lens thickness is changed by expanding or compressing peripheral reservoirs.

[0021] In a non-accommodating IOL, the refractive index of the liquid in the central lens may be varied by introducing higher or lower refractive index liquids into the central lens from the peripheral reservoirs. Mixing of the liquids occurs in the central lens. The mixing of the liquids after breaching the barrier between the peripheral reservoir and the central lens is assisted by eye temperature as well as pulsations in the eye.

[0022] The liquid present in the plurality of peripheral liquid reservoirs may each have a different refractive index, which can be used to non-invasively adjust the refractive index of the central lens. Some of the peripheral liquid reservoirs may contain liquids that have refractive indices that are lower than those of the liquid present in the central lens, while others may contain liquids that have refractive indices that are greater than those of the liquid present in the central lens. Yet other peripheral liquid reservoirs may contain compatibilizers that can facilitate compatibility between the liquid present in the peripheral liquid reservoir and that present in the central lens. A compatibilizer is a chemical that can bring about compatibility between two hitherto incompatible liquids. An example of a compatibilizer is a surfactant.

[0023] Disclosed herein too is a method of manufacturing the IOL, which comprises molding or additively manufacturing a central lens and plurality of peripheral liquid reservoirs. In an embodiment, the central lens may be manufactured separately from the peripheral liquid reservoirs. The central lens and the peripheral lens may then be filled with the desired liquids (i.e., having the appropriate refractive indices) and assembled together to form the IOL. In another embodiment, the central lens and the peripheral lens may be manufactured in a single operation (e.g., molding, additive manufacturing, or a combination thereof) and then filled with the desired liquids to form the IOL.

[0024] Disclosed herein too is a method of using an IOL. In one method, an IOL is implanted in the capsule of a patient’s eye and the refractive index of the central lens is altered by selectively mixing the liquid from at least one reservoir of the plurality of peripheral reservoirs with a liquid already present in the central lens. In this first method, the lens is non-accommodating and the refractive index of the central lens can be adjusted by opening (typically via laser-incision) one or more of the peripheral reservoirs to facilitate liquid mixing in the central lens. This changes the refractive index of the liquid in the central lens.

[0025] In a second method, the optical power of the central lens may be changed dynamically by mechanically inducing the peripheral lenses to change in volume (increase or decrease in volume) and thus change the volume of the liquid in the central lens. The change in volume of the central lens to alter the focus of the lens is defined as an accommodating feature of the lens. It can be used as needed for near, mid distance, far or any focal point in between. This second method is dynamic and controlled remotely by external means (via an app on a communication device e.g., a cell phone or a key fob) while the first method is not intended to change over time after initially altering the focusing power of the lens. The accommodating feature is completed through a true change in volume of the central lens (the change in volume results in a change in lens thickness) that is accomplished by increasing or decreasing the volume of liquid in the peripheral reservoirs and hence in the central lens. [0026] In an embodiment, the accommodating lens may also benefit from the potential change in refractive index, using the first method detailed above (i.e., the mixing of liquids of different refractive indices). In this scenario, after implanting the lens, the non-accommodating feature of the lens is activated by altering the refractive index of the lens by opening up some of the peripheral reservoirs to allow the liquids to move into the central lens. As noted above, the liquids mix in the central lens through eye temperature and pulsations, thus permitting the refractive indices of the different liquids to equilibrate. This equilibration of the refractive index in the central lens may then be followed by activating the non-accommodating feature, where the peripheral reservoirs are actively compressed or expanded to release a certain volume of liquid from the peripheral reservoirs to the central lens or vice versa. This results in an increase or decrease in the thickness of the central lens. This accommodating feature only involves changing the central lens thickness without changing the refractive index. Therefore, the accommodating part of compressing or releasing liquid from the peripheral reservoir will involve reservoirs that are not valved.

[0027] FIG. 1 is an exemplary depiction of an IOL 100 that comprises one or more haptic arms 202 (with an optional arm 204 shown in FIG. 1), a central lens 102 surrounded by a plurality of first peripheral liquid reservoirs 104, 106, 108, 110, 112,

114. 116. 118. 120. 122 and 124 (hereinafter “first reservoirs”) each of which is in operational communication with the central lens 102. The first reservoirs 104, 106,

108. 110. 112. 114. 116. 118. 120. 122 and 124 are disposed on the outermost circumference (also referred to herein as the largest circumference or periphery) of the central lens and lie outside the visual axis of the eye. An optional plurality of second peripheral liquid reservoirs 402, 404, 406, 408, 410, 412, 414 and 416 (hereinafter “second reservoirs”) may be disposed on an outer surface of the central lens 102 outside the visual axis but closer to a geometric center of the lens than the first reservoirs. All of the peripheral reservoirs are hermetically sealed. Because the reservoirs are hermetically sealed, they are also highly impermeable to water, water vapor or reactive gases such as oxygen. The liquids in the reservoirs each have a different refractive index from one another and have a different refractive index from the liquid contained in the central lens and may be used to repeatedly adjust the refractive index of the lens without repeated invasive surgeries. [0028] Some of the peripheral reservoirs of the FIG. 1 are in direct and continual fluid communication with the central lens, while others may be walled-off from the central lens. Those peripheral reservoirs that are in continual direct fluid contact with the central lens are used to effect the accommodating feature (changing the thickness of the central lens), while those that are walled-off are used to effect the non-accommodating feature (changing the refractive index of the central lens). In an embodiment, the peripheral reservoirs are in fluid communication with the central lens via a barrier element. For example, the first peripheral reservoir 116 is in fluid communication with the central lens 102 via a barrier element 604 while the first peripheral reservoir 104 is in fluid communication with the central lens 102 via barrier element 606. The barrier elements 604 and 606 are optional.

[0029] The barrier element may be separate from the peripheral reservoir or may be a part of the peripheral reservoir itself. In an embodiment, the barrier element may include a low-permeability seal that may be laser activated through the retina to selectively release the liquid from the reservoir to the central lens or vice versa as needed. The barrier element preferably comprises a different material (i.e., has a different composition) from that used in the polymeric skins of the central lens and the peripheral reservoirs. The laser activation necessitates that the barrier layer can be altered or breached by an applied beam of optical radiation. The walls of the peripheral reservoirs have a thickness of 1 to 500 micrometers, preferably 5 to 50 micrometers, depending on the particular laser mechanism employed (thermal, thermo-mechanical, photo-chemical, photo-disruptive, and the like).

[0030] Laser irradiation includes an application of energy from a laser. The laser is selected from the group consisting of an argon ion laser, a Nd: YAG laser, a frequency-doubled Nd: YAG laser, a diode laser, a Nd:YLF laser, a frequency-doubled Nd:YLF laser, a krypton ion laser, a dye laser, and a helium-neon laser, a Raman- shifted Nd: YAG, a Nd:YVO4 (vandate) laser, a frequency doubled Nd: YAG, Nd:YVO4 (vandate) laser, a Raman-shifted Yb:fiber, a Yb:glass and Yb:YAG laser, a frequency doubled Yb:fiber, Yb:glass and Yb: YAG, and other non-linear optics crystal wavelength shifted lasers, including; frequency doubled Vertical External Cavity Surface Emitting Lasers (VECSELs), sum and difference frequency mixed laser outputs from near infrared (NIR) lasers such as Nd: YVO4, Nd:YAG, using such crystals as BBO. LBO, CLBO, KTP, KD*P, and RTA.

[0031] The IOL of the FIG. 1 can therefore operate entirely in the nonaccommodating mode, the accommodating mode or in both the accommodating and the non-accommodating mode. In a preferred embodiment, the IOL of the FIG. 1 can be operated entirely in the non-accommodating mode.

[0032] FIG. 2 is an expanded view of a section AA’ of the IOL 100 of FIG. 1. FIG. 2 depicts the central lens 102 along two first peripheral liquid reservoirs 104 and 116. The center of the lens B is the point of intersection of the horizontal axis YY’ and the vertical axis XX* of the lens 102. The vertical axis XX* of the central lens is also referred to as the visual axis. The central lens 102 and the plurality of peripheral liquid reservoirs 104, 106, 108, 110, 112, 114, 116, 118, 120, 122 and 124 along with the comprises a hollow, optically transparent polymeric skin that is filled with an optically transparent liquid having a first refractive index.

[0033] With reference to the FIG. 1, the haptic arms - first haptic arm 202 and second haptic arm 204 facilitate stabilizing the lens within the eye after implantation. These arms are structural extensions attached to the central lens. They help to position the IOL securely within the capsular bag, the part of the eye where the natural lens used to be. This stabilization ensures that the lens remains centered and correctly oriented. The haptic arms are designed to be flexible enough to adapt to the natural shape and movements of the eye while maintaining the correct position of the IOL. This flexibility helps accommodate minor variations in the size and shape of the capsular bag among different patients. By maintaining the IOL position and ensuring a tight fit within the capsular bag, the haptic arms can help reduce the likelihood of posterior capsular opacification, a common postoperative complication where the back of the lens capsule becomes cloudy.

[0034] With reference now to FIGS. 1 and 2, the central lens 102 and each of the first reservoirs (104, 106, 108, 110, and so on,) and second reservoirs (402, 404, 406, and so on) comprise a polymeric container that comprises a skin (hereinafter polymeric skin) and a liquid that facilitates correcting of the vision of the patient. It is to be noted that while the central lens in the FIG. 2 is shown to be bi-convex, the central lens may be bi-concave, plano-convex or plano-concave. [0035] For example, with reference to FIG. 2, the central lens 102 comprises an optically transparent polymeric skin 302 with an optically transparent liquid 502 (that has a desired refractive index for correcting the patient’s vision) contained therein. The polymeric skin (of the central lens 102) generally has a different refractive index from the liquid contained therein. The polymeric skin and the liquid contained in the central lens combine to form a single light focusing unit.

[0036] In an embodiment, the polymeric skin may contain a Tone component, a multifocal refractive surface and or surface shape that is operative to enact an enhanced depth of focus. The Toric surface is modifiable through movement of fluid in or out of reservoirs to enact an overall change in sectoral shape. A Tone surface is a surface generated by rotating an arc of a circle about a line that lies in the plane of the circle but does not pass through its center. In mathematics, it is also known as a toroidal surface. In optics, a Toric lens is a lens with different optical power and focal length in two orientations perpendicular to each other.

[0037] In this embodiment, the central lens 102 contains only a single chamber surrounded by the polymeric skin 302 that contains the transparent liquid 502. The first reservoirs 104 and 116 located on section AA’ each comprise an optically transparent polymeric skin 306 and 304 respectively that is filled with an optically transparent liquid 506 and 504, respectively. Each transparent liquid 506 and 504 respectively has a refractive index that is different from that of the refractive index of the liquid in the central lens 102 for correcting the patient’s vision. For example, the first reservoir 104 may have a first liquid with a lower refractive index than the liquid contained in the central lens 102, while the second reservoir 116 may have a liquid with a higher refractive index than the liquid contained in the central lens 102. In other words, each reservoir may contain a liquid that has a different refractive index from that contained in the other reservoirs as well as the liquid contained in the central lens. Some of the reservoirs may contain liquids that have a higher refractive index than the liquid contained in the central reservoir while others contain liquids that have a lower refractive index than the liquid contained in the central reservoir. This feature is discussed in detail later.

[0038] The polymeric skin 302 of the central lens and the polymeric skins of the respective first reservoirs (104, 106, 108, 110, and so on) and second reservoirs (402, 404, 406, and so on) may be the same or different. The polymeric skins are preferably optically transparent and do not react or interact with body liquids or with the liquids contained in them. They are preferably biocompatible. In a preferred embodiment, the polymeric skin 302 for the central lens 102 is optically transparent (having an optical transmissivity of greater than 90%), while the polymeric skin for the first reservoirs (104, 106, 108, 110, and so on) and second reservoirs (402, 404, 406, and so on) has a lower optical transmissivity than the polymeric skin used in the central lens 102.

[0039] In an embodiment, the polymeric skin 302 has a refractive index that is different from that of the refractive index of the liquid contained therein. In an embodiment, the central lens 102 has a polymeric skin 302A on one surface (a first surface) that has a different refractive index from the polymeric skin 302B at an opposing surface (a second surface). The first surface lies opposite to the second surface. In other words, the polymeric skin has a first refractive index on the anterior side and a second refractive index on the posterior side, wherein the first refractive index is different from the second refractive index.

[0040] The polymeric skins used in the central lens and the first and second reservoirs are abrasion resistant, puncture resistant and impact resistant. They do not react with the liquids contained in them and are tough enough to not rupture during installation (thus preventing the liquid contained therein from contacting the parts of the body). They are also degradation resistant and do not undergo degradation upon contacting parts of the body. In an embodiment, the polymeric skin used in the central lens 102 is elastic - i.e., it can be stretched under a deforming force (such as an applied hydrostatic pressure) within its elastic limit and can return to its original dimensions (e.g., size and shape) when the deforming force is removed. In other words, the polymeric skin has a Young’s modulus that is effective to withstand a change in pressure without undergoing plastic deformation.

[0041] In an embodiment, the polymeric skin may be self-sealing. Any incision or puncture made to the central lens 102 or to the reservoirs may then undergo self-healing either at the temperature of the eye or upon activation by a small amount of heat or radiation (e.g., laser radiation). [0042] A preferred refractive index for the polymeric skin of the central lens 102 is 1.41 to 1.58. This range ensures suitable optical performance and compatibility with the human eye's natural optics. IOLS made from hydrophilic materials include hydrogels and have refractive indices of 1.41 to 1.46. These lenses tend to be more flexible and easier to fold, allowing for smaller incisions during surgery. IOLs made from hydrophobic materials include certain acrylics and have refractive indices of 1.51 to 1.55. These lenses usually provide better optical quality and reduced chromatic aberration but may require slightly larger incisions.

[0043] The polymeric skins may be selected from a wide variety of thermoplastic polymers, blend of thermoplastic polymers, thermosetting polymers or blends of thermoplastic polymers with thermosetting polymers. The organic polymer may also be a blend of polymers, copolymers, terpolymers, or combinations comprising at least one of the foregoing organic polymers. The organic polymer can also be an oligomer, a homopolymer, a copolymer, a block copolymer, an alternating block copolymer, a random polymer, a random copolymer, a random block copolymer, a graft copolymer, a star block copolymer, a dendrimer, a polyelectrolyte (polymers that have some repeat groups that contain electrolytes), a polyampholyte (a polyelectrolyte having both cationic and anionic repeat groups), an ionomer, or the like, or a combination comprising at last one of the foregoing organic polymers. The organic polymers have number average molecular weights greater than 10,000 grams per mole, preferably greater than 20,000 g/mole and more preferably greater than 50,000 g/mole. The organic polymer typically has a number average molecular weight of less than 2,000,000 g/mole, preferably less than 1,500,000 g/mole.

[0044] Examples of polymeric skins include a polyacrylic, a polycarbonate, a polyolefin, a polyester, a polyurethane, a polysiloxane, a polyimide, a polyetherimide, a polyfluoroethylene, or the like, or a combination thereof. In a preferred embodiment, the polymeric skin comprises a polyacrylic resin.

[0045] The liquids contained in the central lens and the first reservoirs (104, 106, 108, 110, and so on) and second reservoirs (402, 404, 406, and so on) can have a refractive indices of 1.2 to 1.8. The liquids are preferably optically transparent and do not react or interact with any of the polymeric skins. The liquids in the central lens are preferably compatible with those stored in the reservoirs and do not undergo phase separation upon contacting each other. In an embodiment, the liquid contained in the central lens has a refractive index of 1.35 to 1.65, preferably 1.40 to 1.55.

[0046] The stored liquid contained in some of the first reservoirs ( 104, 106,

108. 110, and so on) and second reservoirs (402. 404, 406, and so on) may be lower in refractive index than the refractive index of the liquid in the central lens, while in other reservoirs the stored liquid may have a higher refractive index than the liquid in the central lens. Examples of liquids that may be stored in the first reservoirs (104,

106. 108. 110, and so on) and the second reservoirs (402, 404, 406, and so on) include for example: aliphatic hydrocarbons such as hexane and heptane; aromatic hydrocarbons such as toluene and xylene; halogenated hydrocarbons such as dichloromethane, 1,2-dichloroethane and 1 -chlorohexane; alcohols such as methanol, ethanol, 1 -propanol, iso-propanol, tert-butanol, 2-methyl-2-butanol and 4-methyl-2- pentanol; propylene glycol monomethyl ether (PGME), ethers such as diethyl ether, tetrahydrofuran, 1,4-dioxane and anisole; ketones such as acetone, methyl ethyl ketone, methyl iso-butyl ketone, 2-heptanone and cyclohexanone (CHO); esters such as ethyl acetate, n-butyl acetate, propylene glycol monomethyl ether acetate (PGMEA), ethyl lactate (EL), hydroxyisobutyrate methyl ester (HBM) and ethyl acetoacetate; lactones such as gamma-butyrolactone (GBL) and epsilon-caprolactone; lactams such as N-methyl pyrrolidone; nitriles such as acetonitrile and propionitrile; cyclic or non-cyclic carbonate esters such as propylene carbonate, dimethyl carbonate, ethylene carbonate, propylene carbonate, diphenyl carbonate, and propylene carbonate; polar aprotic solvents such as dimethyl sulfoxide and dimethyl formamide; water; or the like, or a combination thereof. A preferred liquid for storage in the reservoirs are water, ethanol, or a combination thereof. Each reservoir may contain, for example, water and ethanol in different ratios. In a preferred embodiment, the polymeric skin of the central lens and the peripheral reservoirs comprise a hydrophobic acrylic and the liquids comprise a silicone oil (an oil that comprises polydimethylsiloxane).

[0047] With reference to the FIG. 1, some of the first reservoirs (104, 106, 108, 110, and so on) and second reservoirs (402, 404, 406, and so on) are not initially filled with a liquid (during installation of the lens in the eye capsule). These reservoirs are left empty so that existing liquid from the central lens can be discharged into these empty reservoirs when it is desirable to correct the refractive index of the central lens. In an embodiment, the reservoirs on one side of the central lens can be filled with liquids that have lower refractive index liquids (compared with the refractive index of the liquid in the central lens), while the reservoirs on the opposite side can be filled with liquids that have higher refractive indices than the liquid in the central lens. Such an arrangement facilitates a transfer of the appropriate liquid from the reservoir to the central lens without any confusion. The central lens may contain identification markings that help the doctor to identify the low refractive index containing reservoirs from the high refractive index containing reservoirs.

[0048] In an embodiment, the first reservoirs (104, 106, 108, 110, and so on) on one side of the central lens may contain low refractive index liquids with a periodic difference in the refractive index while those on the opposing side may contain high refractive index liquids with a periodic difference in the refractive index. For example, the refractive index of the liquid in the central lens 102 may be 1.45. The reservoirs on one side of the central lens may have liquids with a lower refractive index of less than 1.45, while those on the opposing side of the lens may contain a liquid with a higher refractive index than 1.45. For example, the first reservoir 104 may be used to store a first liquid having a refractive index of 1.35. while neighboring first reservoir 106 may contain a second liquid having refractive index of 1.37, first reservoir 108 may contain a third liquid having refractive index of 1.39 and so on (a refractive index difference of 0.02 between neighboring reservoirs). The refractive indices of the liquids in the reservoirs on the other side of central lens may be larger than 1.45. For example, the first reservoir 114 may be used to store a first liquid having a refractive index of 1.49, while neighboring first reservoir 116 may contain a second liquid having refractive index of 1.51, first reservoir 118 may contain a third liquid having refractive index of 1.53 and so on (a refractive index difference of 0.02 between neighboring reservoirs). Such a systematic arrangement of refractive index liquids in the reservoirs permits non-invasive changing the refractive index of the central lens with minimal confusion.

[0049] As noted above, in a non-accommodating lens, the liquid contained in the central lens is walled off from the liquid contained in the peripheral reservoirs. The separation of these respective liquids from each other may be effected by the polymeric skin or by a valve (see FIG. 5). When it is desired to change the refractive index, the liquid from the peripheral reservoirs may be transferred to the central lens by virtue of an incision made in the polymeric skin. The liquids may undergo mixing in the central lens due to thermal fluctuations brought about by the temperature of the eye of because of mechanical perturbations brought about by pulsations in the eye. Alternatively, as detailed below with respect to FIG. 5, the valves that keeps the respective liquids apart may be activated permitting the liquids to undergo mixing in the central lens, thereby changing the refractive index of the central lens.

[0050] In an embodiment, when it is desired to change the refractive index of the central lens, a breach using laser irradiation may be made in the barrier between the central lens and the desired peripheral reservoirs. Liquid from the peripheral reservoirs may be mixed with the liquid present in the central lens to adjust the refractive index and/or volume of the central lens. In another embodiment, a breach may be made in the barrier element via laser irradiation to effect a transfer of liquid from the peripheral reservoir to the central lens or vice versa. Mixing of the liquids in the central lens may be brought about by thermal fluctuations (e.g., body temperature) and mechanical perturbations (e.g., ocular pulsation) as described above. The polymeric skins and/or the barrier element may be sealed using laser irradiation after the change in the refractive index is completed.

[0051] While the IOL of the FIG. 1 is preferably operated in the nonaccommodating mode, it can also be operated in the accommodating mode. In other words, some of the peripheral reservoirs (first reservoirs (104, 106, 108, 110, and so on) and second reservoirs (402, 404, 406, and so on)) may be in direct open fluid communication with the central lens 102 and liquids from the reservoirs can be forced into the central lens 102 or vice versa thus changing the thickness and curvature of the central lens and hence it’s focusing power.

[0052] FIGS. 3 and 4 are exemplary schematic cross-sectional depictions of an IOL 100 that can operate in the non-accommodating mode, the accommodating mode, or in both the accommodating and non-accommodating mode. In a preferred embodiment, the IOLS of the FIGS. 3 and 4 are both operated in the accommodating mode. [0053] FIGS. 3 and 4 have the same overall architecture as the IOL depicted in the FIG. 1, except for the central lens 102. The central lens 102 of the FIGS. 3 and 4 each contain two chambers M and N for receiving an optical fluid. The optical fluid may be similar to the liquid used in the FIG. 2 or alternatively, it may be a transparent amorphous polymeric gel that has a high viscosity (that renders it relatively immobile). In an embodiment, the refractive index of the gel may be modified by using an external light source. In an embodiment, the central lens thickness is unchanged when modifying the refractive index through selectively polymerizing portions of the gel in the central lens.

[0054] FIG. 3 is a cross-sectional view of the IOL 100 of FIG. 1, except that the central lens 102 has two chambers M and N. In an embodiment, M and N may contain different liquids that have differing refractive indices. For example, chamber M may contain a liquid having a first refractive index, while chamber N may contain a liquid having a second refractive index that is different from the first refractive index. When it is desired to operate the lens in the accommodating mode, the refractive index of the lens is changed and a different liquid from the first reservoirs (104, 106, 108, 110, and so on) and second reservoirs (402, 404, 406, and so on) may be transferred to chamber M, chamber N or to both chambers M and N to correct a patient’s sight. There is no liquid transfer between the chambers M and N. It is to be noted that the refractive index of the polymeric skin of the central lens 102 is different from the refractive index of either of the liquids contained in chamber M or chamber N.

[0055] In an embodiment, chamber M may contain a higher viscosity, optically transparent gel. The gel in chamber M typically has a different refractive index from the liquid in chamber N. In this event, only the refractive index can be changed by transporting a liquid from one of the reservoirs to the chamber N. As noted above, the original liquid from the chamber N can be transported to one of the empty reservoirs, and liquids from a plurality of reservoirs may be transported into the chamber N of the lens 102. In another embodiment, the liquid from one or more reservoirs may be transferred to the central lens, where it is mixed to produce a liquid with a new refractive index that improves the patient’s vision. [0056] In another embodiment, when the IOL of the FIG. 3 is operated in the accommodating mode, the amount of liquid transported into the chamber N of lens 102 may be sufficient to change the thickness of the central lens 102. This change in thickness changes the focusing power of the lens. The IOL of the FIG. 3 can therefore function as an accommodating lens (where focusing power is changed due to a change in thickness), a non-accommodating lens (where its dimensions never change, but only refractive index of the lens is changed due to a mixing of liquids), or a combination of accommodating and non-accommodating lens (where both refractive index and focusing power are changed). As noted above, it is desirable to use the IOL of the FIG. 3 in the accommodating mode (one where thickness is changed by changing the volume of liquid present in the central lens).

[0057] FIG. 4 is another cross-sectional depiction of the IOL 100 of FIG. 1, except that the central lens 102 has two chambers M and N, one of which is located inside the other. In the FIG. 4, chamber N lies inside chamber M. The IOL of the FIG. 4 can be operated in either the accommodating mode, the non-accommodating mode, or both -the accommodating and non-accommodating mode.

[0058] The liquid contained in chamber M surrounds chamber N. There is no liquid transfer between the chambers M and N. In an embodiment, chamber N may contain a transparent gel while chamber M may contain a liquid that has a different refractive index from that of the gel. When operated in the accommodating mode and a change in the refractive index of the IOL is desired, a liquid from one or more of the first reservoirs (104, 106, 108, 110, and so on) and/or one or more of the second reservoirs (402, 404, 406, and so on) may be transferred to chamber M.

[0059] In another embodiment, when it is desired to operate this IOL in the non-accommodating mode, the amount of liquid transported into the chamber M of lens 102 may be sufficient to change the thickness and curvature of the central lens 102 thereby changing the focus of the lens. The lens can therefore function as an accommodating lens.

[0060] In one embodiment, in one method of manufacturing the IOL of the FIGS. 1 - 4, the central lens 102 as well as the first reservoirs (104, 106, 108, 110, and so on) and the second reservoirs (402, 404, 406, and so on) may be manufactured through molding (e.g., processes such as vacuum forming, blow molding, compression molding, injection molding, or a combination thereof). In an embodiment, additive manufacturing may be used to manufacture the IOL of the FIGS. 1 to 4. In another embodiment, a portion of the IOL may be manufactured via conventional manufacturing processes such as vacuum forming, blow molding, compression molding, injection molding while a remaining portion may be manufactured via additive manufacturing. For example, the central lens 102 may be manufactured via the conventional processes listed above, while the first reservoirs (104, 106, 108, 110, and so on) and the second reservoirs (402, 404, 406, and so on) may be manufactured via additive manufacturing.

[0061 j After the manufacturing of the central lens as well as the reservoirs, they may be filled with the desired liquids. The IOL may then be stored for transfer to a patient in need to improved sight.

[0062] In an embodiment, in one method of using the IOL, a patient may be provided with the appropriate IOL for correcting sight after cataract surgery. The central lens 102 of the IOL is selected depending upon the patient’s eye's natural optics. An incision is made in the lens capsule and the IOL may be inserted in lieu of the defective lens. If a change in the replacement IOL is desired after surgery, then the lens capsule may be reopened. A laser beam can be used to make an incision in the polymeric skins of the central lens and one or more reservoirs and some of the original liquid from the central lens may be mixed with liquid from the reservoirs to change the refractive index. The incisions in the central lens 102 and the respective reservoirs may then be sealed using the laser beam. In an embodiment, the optic muscles may be used to facilitate mixing between different liquids in order to correct for the refractive index of the lens. The temperature of the eye also plays a role in the mixing of the liquids.

[0063] In yet another embodiment, depicted in the cross-sectional view of FIG. 5, each the first reservoir (104, 106, 108, 110, and so on) and the second reservoir (402, 404, 406, and so on) may be in fluid communication with the central lens 102 via a microfluidic valve. This arrangement may be used to facilitate operating the IOL in the non-accommodating mode. In the FIG. 5, the first reservoirs 104 and 116 are in fluid communication with the central lens 102 via microfluidic valves 502 and 504 respectfully. Microfluidic valves may be used for the precise control of fluid flow from the first reservoir (104. 106, 108, 110. and so on) and the second reservoir (402, 404, 406, and so on) to the central valve 102. Examples of microfluidic valves include pinch valves (which can be as small as a few hundred micrometers in width), needle valves (which have needle diameters of 100 pm to 1 mm), solenoid valves, thermally actuated valves (around 100 pm to 1 mm, depending on the heating element and the material used) and capillary valves (which have dimensions (width and depth) of 10 to 100 pm). These microfluidic valves activated by suitable stimuli. The stimuli can be pressure-driven (operate by applying external pressure to open or close the valve), electrically actuated (use electric signals to control the opening and closing, often seen in solenoid and electrokinetic valves), thermally actuated (changes in temperature cause expansion or contraction of materials to control the flow), thermally actuated, ultrasonically actuated, or chemically actuated.

[0064] When a change in the refractive index of the IOL 100 is desired, one or more of the activation stimuli may be applied to the reservoirs and/or the central lens 102 to bring about the desired change in lens power. The design of FIG. 5 prevents additional surgery in order to correct the patient’s sight.

[0065] The aforementioned lens of FIGS. 1 to 5 are advantageous in that they minimize repeated surgeries in order to correct a patient’s sight. The change in the refractive index occurs through movement of liquid from the periphery to central zones while the change in focusing power occurs through changing the thickness of the lens by increasing the volume of liquid in the central lens. The lens can be manufactured before-hand and stored for use at any given moment.

[0066] The intraocular lens disclosed herein are exemplified by the following non-limiting examples.

EXAMPLE

Example 1

[0067] This example was conducted to demonstrate how fluids of different refractive indices may be mixed to produce a blended fluid with an intermediate refractive index Rl). In this example, the fluids are oils. The measured refractive index for the 3 synthesized silicone oils is as follows: Oil 1 - 1.4112

Oil 2 - 1.4211

OH 3 - 1.4323

[0068] This study was divided into four groups (Group 1, Group 2. Group 3 and Group 4). Details are provided below. Refractive index measurements were made with reference to ISO 489 and ASTM D542 with the use of appropriate refractometry methods.

[0069] Group 1 - Oil 2 (RI = 1.42) and Oil 1(RI = 1.41) were mixed at various ratios with no agitation and maintained at 35°C for at least 90 days. The refractive index of the blend was measured on day 1, 7, 15, 30, 45, 60, and 90 after the mixing. Table 1 shows the weight percentages used for the blends of Group 1.

Table 1

[0070] Group 2 - Oil 2 (RI = 1.42) and Oil 3 (RI =1.43) were combined at various weight ratios with no agitation and maintained at 35°C for at least 90 days. The refractive index was measured on day 1, 7, 15, 30, 45, 60, and 90. Table 2 shows the weight percentages for the blends of Group 2.

Table 2 [0071] Group 3 - Six vials of Oil 2 (RI = 1.42) and Oil 1 (RI = 1.41) were combined in a 1 :1 weight ratio with no agitation and maintained at 35°C. After 7 days, the refractive index was measured of the 1 : 1 weight ratio mix following which an additional amount of 1.42 oil was added to each of the six vials. The refractive index was then measured on Day 8, 14, 22, 37, 52. 67, and 97. Table 3 shows the weight percentage breakdown for each of the six vials.

Table 3

[0072] Group 4 - Six vials of Oil 2 (RI = 1.42) and Oil 3(RI = 1.43) were combined at 1 : 1 weight ratio with no agitation and maintained at 35 °C. After 7 days, the refractive index was measured of the 1:1 weight ratio mix following which an additional amount of the Oil 2 (RI =1.42) was added to each of the six vials. The refractive index was then measured on Day 8, 14, 22, 37, 52. 67, and 97. The following are the weight percentage breakdown for each of the six vials.Table 4

[0073] The refractive indices for the respective blends of Group 1, Group 2, Group 3 and Group 4 are shown in Tables 5 - 8 respectively. In the Tables 5 - 8, the refractive indices of the blends are shown over a period of 90 days or 97 days to determine their stability at 35°C. Table 5 depicts the refractive indices of the blends of Group 1 for 90 days. Table 6 depicts the refractive indices of the blends of Group 2 for 90 days. Table 7 depicts the refractive indices of the blends of Group 3 for 97 days. Table 8 depicts the refractive indices of the blends of Group 4 for 97 days.

Table5

Table 6

23

[0074] From the Tables 5 - 8 it may be seen that the silicone oils mixed at different ratios without any agitation display a stable refractive index for 90 days at 35°C.

[0075] While the invention has been described with reference to some embodiments, it will be understood by those skilled in the art that various changes may be made and equivalents may be substituted for elements thereof without departing from the scope of the invention. In addition, many modifications may be made to adapt a particular situation or material to the teachings of the invention without departing from essential scope thereof. Therefore, it is intended that the invention not be limited to the particular embodiments disclosed as the best mode contemplated for carrying out this invention, but that the invention will include all embodiments falling within the scope of the appended claims.

Claims

CLAIMS What is claimed is:

1. An intraocular lens comprising: a central lens; and a plurality of peripheral reservoirs in fluid communication with the central lens; wherein a liquid is transported from at least some of the plurality of peripheral reservoirs to the central lens and from the central lens to at least some of the plurality of peripheral reservoirs without a change in a volume of the central lens.

2. The intraocular lens of Claim 1, where a change in refractive index of the central lens occurs by mixing a liquid from at least one peripheral reservoir of the plurality of peripheral reservoirs with a liquid in the central lens.

3. The intraocular lens of Claim 1, wherein a portion of the plurality of peripteral reservoirs contain liquids that have a lower refractive index than that of the liquid contained in the central lens and wherein a portion of the plurality of peripheral reservoirs contain liquids that have a higher refractive index than that of the liquid contained in the central lens.

4. The intraocular lens of Claim 1 , wherein the central lens comprises a polymeric skin with a liquid contained therein; wherein the polymeric skin has a refractive index that is different from that of the liquid contained in the central lens; and wherein the polymeric skin and the liquid contained in the central lens combine to form a single light focusing unit.

5. The intraocular lens of Claim 4, wherein the polymeric skin has a first refractive index on the anterior side and a second refractive index on the posterior side; and wherein the first refractive index is different from the second refractive index.

6. The intraocular lens of Claim 5, wherein the polymeric skin separates a liquid contained in the central lens from a plurality of different liquids contained in the plurality of peripheral reservoirs and wherein the liquid is transported from the central lens to the plurality of peripheral reservoirs or from the plurality of peripheral reservoirs to the central lens after an incision is made in a barrier element that is present between the polymeric skin and at least one peripheral reservoir of the plurality of peripheral reservoirs.

7. The intraocular lens of Claim 1, wherein the central lens comprises two chambers - a first chamber that has a first liquid having a first refractive index and a second chamber that has a second liquid having a second refractive index, where the first refractive index is different from the second refractive index.

8. The intraocular lens of Claim 1 , wherein the central lens comprises two chambers - a first chamber that has a first liquid having a first refractive index and a second chamber that has a gel that has a second refractive index, where the first refractive index is different from the second refractive index.

9. The intraocular lens of Claim 4, wherein the polymeric skin comprises a Toric component, a multifocal refractive surface and or surface shape that is operative to enact an enhanced depth of focus.

10. The intraocular lens of Claim 8, wherein the polymeric skin comprises a Toric component that is modifiable through movement of the liquid in or out of the peripheral reservoirs to enact an overall change in sectoral shape.

11. The intraocular lens of Claim 1, wherein the central lens further comprises a chamber that contains a polymeric gel; wherein the polymeric gel is operative to increase or decrease the refractive index of the central lens.

12. The intraocular lens of Claim 1, wherein the central lens comprises two chambers - a first chamber and a second chamber.

13. The intraocular lens of Claim 12, where the second chamber lies within the first chamber.

14. The intraocular lens of Claim 12, where the second chamber lies adjacent to the first chamber.

15. The intraocular lens of Claim 4, wherein the polymeric skin comprises a polyacrylate and wherein the liquid comprises a silicone oil.

16. An intraocular lens comprising: a central lens; and a plurality of peripheral reservoirs in fluid communication with the central lens; wherein a liquid is transported from at least some of the plurality of peripheral reservoirs to the central lens causing a change in a volume of the central lens and changing the focusing power of the central lens.

17. The intraocular lens of Claim 16, wherein the change in the volume of the central lens is not accompanied by a change in the refractive index of the central lens.

18. The intraocular lens of Claim 17, wherein the change in the volume of the central lens is activated remotely.

19. A method of using an intraocular lens, the method comprising: disposing the intraocular lens in the lens capsule of a patient’s eye; where the intraocular lens comprises: a central lens; and a plurality of peripheral reservoirs in fluid communication with the central lens; and transporting a liquid from at least some of the plurality of peripheral reservoirs to the central lens and from the central lens to at least some of the plurality of peripheral reservoirs.

20. The method of Claim 19, wherein the transporting of the liquid from at least some of the plurality of peripheral reservoirs to the central lens or from the central lens to at least some of the plurality of peripheral reservoirs facilitates a change in volume of the central lens and/or a change in refractive index of the central lens.