Variable thickness dynamic membrane for accommodative intraocular lenses

Abstract

An intraocular lens having an anterior optic with a central dynamic zone configured to undergo a shape change for accommodative function, the anterior optic including a dynamic membrane having a differential thickness gradient between its posterior and anterior surfaces. Related devices and methods are provided.

Description

[Technical field]

[0001] Cross-references to prior literature This application claims priority to co-pending U.S. Provisional Application Serial No. 63 / 136,843, filed January 13, 2021, the entire disclosure of which is incorporated herein by reference. [Background technology]

[0002] A healthy, young human eye can focus on distant or near objects as needed. The eye's ability to switch between near and far vision is called accommodation. Accommodation occurs when the ciliary muscles contract, releasing the residual zonular tension at the equator of the capsular bag. The release of zonular tension changes the inherent elasticity of the lens to become more spherical or spherical, increasing the curvature of the lenticular surfaces, both anterior and posterior.

[0003] The human eye 10 includes the cornea 12, iris 14, sulcus 16, ciliary muscle 18, zonules 20, and lens 21 housed within a capsular bag 22 (FIGS. 1A and 1C). Accommodation occurs when the ciliary muscle 18 contracts, releasing the resting zonular tension on the equatorial region of the capsular bag 22. The release of zonular tension causes the inherent elasticity of the lens 21 to become more spherical or spherical, increasing the surface curvature of both the anterior lens surface 23 and the posterior lens surface 24. Additionally, the human lens may suffer from one or more disorders that reduce its function in the visual system. A common lens disorder is cataract, which is the opacification of the normally transparent natural crystalline lens matrix 26. Cataracts can be due to aging, but can also be caused by genetics, diabetes, or trauma. FIG. 1A shows a lens capsule including a capsular bag 22 having an opacified, crystalline lens nucleus 26 .

[0004] In cataract surgery, a patient's opaque crystalline lens is replaced with a clear lens implant or intraocular lens (IOL) 30. In a conventional extracapsular cataract surgery as depicted in FIG. 1B, the crystalline lens matrix 26 is removed leaving the thin walls of the anterior and posterior capsules intact along with the zonular ligament attachments to the ciliary body and ciliary muscle 18. The crystalline lens core is removed by phacoemulsification through a curvilinear capsulorhexis, i.e., removal of the anterior portion 23 of the capsule, as shown in FIG. 1B. FIG. 1B shows a conventional three-piece intraocular lens 30 immediately after implantation into the capsular bag 22.

[0005] It is known to implant lenses in combination to address the refractive errors of existing lenses in the case of phakic intraocular lenses, or to improve the refractive results of standard intraocular lenses after cataract surgery in the case of pseudophakic intraocular lens patients. These "piggyback" intraocular lenses can be placed in front of a previously implanted intraocular lens or a natural lens to improve the refractive situation of cataract surgery in the case of pseudocataract, usually to correct high myopia. Generally, these lenses are implanted in the ciliary sulcus and have poor accommodation. As shown in FIG. 1C, the ciliary sulcus 16 is the space between the posterior surface of the base of the iris 14 and the anterior surface of the ciliary body. FIG. 1C also shows the angle of the anterior chamber 25 of the eye.

[0006] Intraocular lenses are typically implanted after cataract extraction. Intraocular lenses are generally made of foldable materials such as silicone or acrylic to minimize incision size and improve patient recovery time. The most commonly used intraocular lenses are monofocal lenses that provide a single focal length for distance vision. Accommodative intraocular lenses (AIOLs) have also been developed to provide an adjustability (or adaptability) of focal length that relies on the eye's natural focusing ability, as described, for example, in US2009 / 0234449, US2009 / 0292355, US2012 / 0253459, US10,258,805, and US2019 / 0269500, each of which is incorporated herein by reference in its entirety. AIOLs are beneficial for patients who do not suffer from cataracts but wish to reduce their reliance on glasses and contacts to correct myopia, hyperopia, and presbyopia. Intraocular lenses used to correct large errors in myopic, hyperopic, and astigmatic eyes are called "phakic intraocular lenses" and are implanted without removing the crystalline lens. In some cases, even if cataracts are not present, an aphakic (not phakic) intraocular lens may be implanted through a lens extraction and exchange procedure. In this procedure, the lens is removed and replaced with an intraocular lens, a process very similar to cataract surgery. Refractive lens exchange involves lens exchange similar to cataract surgery, with a small incision in the eye for lens insertion, local anesthesia, and takes about 30 minutes.

[0007] Intraocular lenses, particularly accommodative intraocular lenses, can incorporate a liquid in a fluid chamber such that accommodation is achieved with the aid of a fluid actuation mechanism. A force applied to a portion of the lens is transmitted through the liquid, deforming the flexible layer of the lens and changing the accommodative shape of the intraocular lens. For example, the ciliary muscle movement of the eye can be utilized by components of an AIOL to facilitate shape change and accommodation. AIOLs can achieve a desired range of optical power or diopter (D) by shape change of the optic due to a small amount of force (e.g., only 0.1 to 1.0 grams of force (gf)) applied by the ocular tissue. AIOLs provide reliable dioptric change by utilizing small forces. A chamber for containing a liquid material formed by a flexible layer of an elastomeric material can change the shape, and therefore the power, of the lens depending on the volume of the liquid. When the filling volume increases beyond the chamber volume, the flexible layer bulges outward, creating a lens with a larger focal length.

[0008] There is a need in the art for improved flexible layers of shape-changing lenses that provide improved properties to patients in need. The present disclosure is directed to this as well as other important objectives. Summary of the Invention

[0009] An accommodative intraocular lens is provided having an anterior optic. The anterior optic includes a central dynamic zone configured to undergo a shape change for accommodation with a dynamic membrane having a differential thickness gradient between a posterior surface of the dynamic membrane and an anterior surface. The anterior optic includes a peripheral static zone having a static anterior optical portion configured to resist the shape change. The optic also includes an incompressible optical fluid contained within a fluid chamber partially defined by the posterior surface of the dynamic membrane. Compressing the fluid chamber in a first region changes the shape of the central dynamic zone to provide accommodation.

[0010] The anterior surface of the dynamic membrane may be a convex surface and the posterior surface of the dynamic membrane may be a flat surface. The anterior surface may control the differential thickness gradient of the dynamic membrane, and the gradient may change gradually between the periphery and the center of the dynamic membrane. The anterior surface of the dynamic membrane may have a convex curvature that is a single radius or an aspheric equation. The static anterior optic may have an anterior surface that has a curvature that is the same or different than the convex curvature of the anterior surface of the dynamic membrane. The anterior surface of the dynamic membrane may be a convex surface and the posterior surface of the dynamic membrane may be a convex surface. Both the anterior and posterior surfaces control the differential thickness gradient of the dynamic membrane, and the gradient may change abruptly between the periphery and the center of the dynamic membrane. The anterior surface of the dynamic membrane may have a convex curvature that is a single radius or an aspheric equation. The posterior surface of the dynamic membrane may have a convex curvature that is a single radius or an aspheric equation. The static anterior optic may have an anterior surface that has a curvature that is the same or different than the convex curvature of the anterior surface of the dynamic membrane. The anterior surface of the dynamic membrane may be a convex surface and the posterior surface of the dynamic membrane may be a concave surface. Both the anterior and posterior surfaces control the differential thickness gradient of the dynamic membrane, allowing the gradient to change gradually between the periphery and center of the dynamic membrane. The anterior surface of the dynamic membrane can have a convex curvature that is a single radius or an aspheric equation. The posterior surface of the dynamic membrane can have a concave curvature that is a single radius or an aspheric equation. The static anterior optic can have an anterior surface that has a curvature that is the same or different than the convex curvature of the anterior surface of the dynamic membrane.

[0011] The anterior surface of the dynamic membrane can be convex and the posterior surface of the dynamic membrane can be convex at the periphery of the dynamic membrane and flat near the center of the dynamic membrane. At the periphery of the dynamic membrane, both the anterior and posterior surfaces can control the differential thickness gradient of the dynamic membrane, and at the center, only the anterior surface can control the differential thickness gradient of the dynamic membrane. The gradient can vary nonlinearly between the periphery and center of the dynamic membrane. The anterior surface of the dynamic membrane can have a convex curvature that is a single radius or an aspheric equation. The posterior surface of the dynamic membrane near the periphery can have a concave curvature that is a single radius or an aspheric equation. The static anterior optic can have an anterior surface that has the same or different curvature as the convex curvature of the anterior surface of the dynamic membrane near the periphery. The anterior surface of the dynamic membrane after accommodation can be spherical and the optical fluid can have a higher refractive index than the anterior optic. The anterior surface of the dynamic membrane after accommodation can be aspheric and the optical fluid can have a lower refractive index than the anterior optic. [Brief description of the drawings]

[0012] These and other aspects are described in detail below with reference to the following drawings: In general, the figures are illustrative and are intended to be schematic representations, not to scale in absolute or relative terms, and the relative placement of features and elements has been altered for illustrative clarity.

[0013] [Figure 1A] FIG. 1A is a cross-sectional perspective view of an eyeball with an opacified lens capsule. [Figure 1B] FIG. 1B is a cross-sectional perspective view of the eye of FIG. 1A with the curvilinear capsule and lens matrix removed and a conventional three-piece intraocular lens implanted. [Figure 1C] FIG. 1C is a cross-sectional view of the anterior angle of the eye. [Figure 2A] FIG. 2A is a schematic top view of an accommodative intraocular lens. [Figure 2B] FIG. 2B is a cross-sectional view of the accommodative intraocular lens taken along line BB of FIG. 2A. [Figure 3A] FIG. 3A is a cross-sectional view of the lens of FIG. 2B illustrating various anterior optic shapes. [Figure 3B] FIG. 3B is a cross-sectional view of the lens of FIG. 2B illustrating various anterior optic shapes. [Figure 3C] FIG. 3C is a cross-sectional view of the lens of FIG. 2B illustrating various anterior optic shapes. [Figure 3D] FIG. 3D is a cross-sectional view of the lens of FIG. 2B illustrating various anterior optic shapes. [Figure 3E] FIG. 3E is a cross-sectional view of the lens illustrating the anterior optic shape. [Figure 3F] FIG. 3F is a schematic diagram of the dynamic membrane of the lens of FIG. 3E, having an aspheric accommodative shape. [Figure 3G] FIG. 3G is a cross-sectional view of a lens illustrating the anterior optic shape. [Figure 3H] FIG. 3H is a schematic diagram of the dynamic membrane of the lens of FIG. 3G, having a spherical accommodative shape. [Figure 3I-1] FIG. 3I-1 is an image of the anterior membrane using an optical measurement device to evaluate the optical quality of a lens having a solid and liquid component, where the RI of the liquid component is lower than the RI of the solid component. [Figure 3I-2] FIG. 3I-2 is a schematic diagram of FIG. 3I-1 showing light rays passing through the solid and fluid components of the lens. [Figure 3J-1] FIG. 3J-1 is an image of a pre-film using an optical metrology device to evaluate the optical quality of a lens having a solid and liquid component, where the liquid component has an RI that is index-matched to the RI of the solid component. [Figure 3J-2] FIG. 3J-2 is a schematic diagram of FIG. 3J-1 showing light rays passing through the solid and fluid components of the lens. [Figure 4A] FIG. 4A is a perspective view of a lens implant. [Figure 4B] FIG. 4B is a side view of the lens of FIG. 4A. [Figure 4C] FIG. 4C is a rear perspective view of the lens of FIG. 4A. [Figure 4D] FIG. 4D is a side view of the lens of FIG. 4A. [Figure 4E] FIG. 4E is a cross-sectional view of the lens of FIG. 4A. [Figure 4F] FIG. 4F is a cross-sectional view of the lens of FIG. 4A. [Figure 4G] FIG. 4G is a cross-sectional view of the lens of FIG. 4A, showing the support structure of the lens. [Figure 4H] FIG. 4H is a top view of the lens of FIG. 4A, showing the diameters of the various elements of the lens. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0014] It is important for lenses, especially intraocular lenses (IOLs), to have high quality optics that avoid stray light, glare, or unintended reflections reaching the retina. Lenses generally allow light to reach the retina after being refracted at optically designed lens surfaces. Light from the lens edge at the non-optical interface between the lens edge and aqueous humor can cause dysphotopsias, which are common in commercially available lenses known in the art. Light scattering dysphotopsias are troublesome to patients. Similarly, any interface between two materials with different refractive indices within a lens can cause light to reach the patient's retina in a manner that disrupts clear, quality vision. Maintaining a predictable shape of the lens throughout its life, especially during and after lens reshaping, provides the correct optical power to properly focus light on the patient's retina.

[0015] The lenses described herein utilize the movement of the ciliary body tissue to deform the walls of the lens body, also referred to herein as the dynamic optical membrane, into an enlarged shape for near vision. Described herein are lens bodies having walls or optical membranes with a controlled, continuous thickness gradient from the periphery to the center, which deform into a desired optical surface shape for near vision under the uniform application of a pressure load to an optical fluid chamber.

[0016] 2A-2B are schematic, partial views of an accommodative intraocular lens that generally includes solid optical components and liquid optical materials. The lens 100 can include an anterior optic 145 having a central dynamic zone formed by a dynamic membrane 143 surrounded by a peripheral static zone formed by a static anterior optic portion 144. The dynamic membrane 143 of the anterior optic 145 is configured to undergo a shape change for accommodative function, while the static anterior optic portion 144 of the anterior optic 145 is configured to resist the shape change. The dynamic membrane 143 can have a differential thickness gradient to provide precise control over the shape of the membrane 143 and the overall optical performance during shape change. The dynamic membrane 143 can be designed to have different thickness gradients to provide different membrane shapes that provide the best optical performance for a particular AIOL. The thickness gradient across the dynamic membrane 143 may be defined by the curvatures of the anterior (outer) surface 1430 and posterior (inner) surface 1435 of the dynamic membrane 143, and in some embodiments the curvature of the anterior surface 1440 of the static anterior optic portion 144 (see FIG. 3A). The particular combination of curvatures of the anterior surface 1430, 1440 and posterior surface 1435 of the dynamic membrane 143 can provide improved optical quality.

[0017] The terms "anterior" and "posterior" as used herein are used to indicate relative frames of reference, positions, directions or orientations for understanding and clarity. The use of the terms is not intended to limit the structure and / or implantation of the lens. For example, the lens can be oriented in the eye such that the anterior optic 145 is positioned anteriorly along the optical axis A of the lens 100 relative to the anatomy of the eye, with the anterior surface facing the cornea and the posterior surface facing the retina. However, the anterior optic 145 can also be positioned posteriorly relative to the ocular anatomy. A membrane as used herein can refer to a wall of the lens body that forms part of a sealed fluid chamber of the lens body that contains an incompressible optical fluid, and is generally configured to move upon application of a force during use of the intraocular lens to achieve an adjustable shape change of the lens body.

[0018] 2B, the solid optical components of the lens 100 form a sealed, fixed-volume fluid chamber 155 that contains a fixed volume of liquid optical material. The fluid chamber 155 may be defined in part by an interior sidewall 1550 that may be vertical, sloped, curved, or a combination thereof. The shape of the sidewall 1550 of the chamber 155, and thus the shape of the dynamic membrane 143 and static anterior optic portion 144, may vary. The shape selected for the solid components may depend on whether the liquid optical material contained within the chamber 155 of the lens has the same or a different refractive index as the solid optical components, as will be described in more detail below.

[0019] The anterior optic 145 can have a convex outer anterior-facing surface with a single radius of curvature or different radii of curvature. The anterior radius of curvature can be defined as the distance between a central fixed point in the lens body and the anterior surface 1430 of the dynamic membrane 143. A constant single radius profile is one in which the anterior surface 1430 of the membrane 143 follows a regular circular arc that is always the same distance from the central point. An aspheric profile deviates from a regular spherical curve such that a single radius of curvature cannot be used to define its overall shape. For example, the anterior surface 1440 of the static anterior optic 144 can have one anterior radius of curvature and the anterior surface 1430 of the dynamic membrane 143 can have a different anterior radius of curvature. The anterior radius of curvature of the dynamic membrane 143 can be greater than, less than, or equal to the anterior radius of curvature of the static anterior optic 144. The posterior surface 1435 of the anterior optic 145 can be convex, concave, flat, or a combination of convex / flat or concave / flat. Like the anterior surface, the posterior surface 1435 can have a posterior radius of curvature that is a single radius or a different radius, a spherical equation or an aspheric equation. Varying the curvature of the anterior surface, posterior surface, or a combination of the anterior and posterior surfaces can control the differential thickness gradient across the dynamic membrane 143 and / or the static anterior optic portion 144.

[0020] In general, the dynamic membrane 143 in the central dynamic zone of the anterior optic 145 is substantially thinner than the static anterior optic portion 144 at the periphery of the anterior optic (see FIGS. 2B and 3A-3D). Due to the curvature of one or both of the anterior surface 1430 and the posterior surface 1435, the dynamic membrane 143 can have a controlled, continuous thickness gradient between the periphery of the membrane near the static anterior optic portion 144 and the center.

[0021] 3A is a schematic diagram of one embodiment of the anterior optic 145 showing the anterior surface 1430 of the dynamic membrane 143 and the anterior surface 1440 of the static anterior optic 144, as well as the posterior surface 1435 of the dynamic membrane 143. The anterior surfaces 1430, 1440 are convex and can have the same or different curvatures. For example, the anterior surface can have a spherical, single radius profile or an aspheric profile. The posterior surface 1435 of the dynamic membrane 143 can be flat. In this embodiment, the surface that controls the differential thickness gradient is the anterior surface 1430 of the dynamic membrane 143, which creates a gradual change in thickness from the peripheral region towards the center of the lens.

[0022] The aspheric profile can be designed using the aspheric equation below:

number

[0023] [Table 1] TIFF2024502638000003.tif36142

[0024] 3B is a schematic diagram of an anterior optic 145 showing different differential thickness gradients. The anterior surfaces 1430, 1440 are convex and can have the same or different curvatures. The posterior surface 1435 of the dynamic membrane 143 is also of convex curvature and can be a single radius or aspheric equation. Both the anterior and posterior surfaces control differential thickness gradients that, in this embodiment, create an abrupt change in thickness from the peripheral region to the center of the lens.

[0025] 3C is a schematic diagram of an anterior optic 145 showing another differential thickness gradient. The anterior surfaces 1430, 1440 are convex and can have the same or different curvatures, which can be single radius or aspheric equation curvature. The posterior surface 1435 of the dynamic membrane 143 is concave curvature and can be single radius or aspheric equation curvature. Both the anterior and posterior surfaces control the differential thickness gradient in this embodiment, but create a gradual change in thickness from the peripheral region to the center of the lens.

[0026] 3D is a schematic diagram of an anterior optic 145 showing another differential thickness gradient. The anterior surfaces 1430, 1440 are convex and can have the same or different curvatures, which can be single radius or aspheric equation curvatures. The posterior surface 1435 of the dynamic membrane 143 can be convex at the periphery and flat in the center. At the periphery, both the anterior and posterior surfaces control the differential thickness gradient, while the anterior surface controls the gradient only in the center. In this embodiment, a nonlinear thickness gradient is formed.

[0027] The cross-sectional thickness of the dynamic membrane 143 can be greatest at the center. The thickness at the center can be 5 to 30 microns thicker than the thickness of the dynamic membrane 143 at the periphery near the static anterior optic portion 144. The center of the dynamic membrane 143 can be greater than 50 microns to about 70 microns, or to about 80 microns, or to about 90 microns, or to about 100 microns, or to about 200 microns, and any range therebetween. In an embodiment, the periphery of the dynamic membrane 143 can have a cross-sectional thickness that is about 50 microns to about 70 microns, and the center of the dynamic membrane 143 can have a cross-sectional thickness that is about 60 microns to about 80 microns.

[0028] The cross-sectional thickness of the static anterior optic 144 may also vary between its outermost peripheral region and a more central region. FIG. 2B shows that the cross-sectional thickness of the static anterior optic 144 is substantially uniform between the peripheral region near the boundary with the dynamic membrane 143 and the central region. The static anterior optic 144 may have an anterior radius of curvature that results in a slightly thinner periphery compared to the central region. FIG. 3A shows that the cross-sectional thickness of the static anterior optic 144 may vary between the peripheral region close to the dynamic membrane 143 and the central region beyond that due to the anterior radius of curvature. The inwardly facing sidewall 1550 formed by the static anterior optic 144 may taper in cross-sectional thickness toward the dynamic membrane 143. As an example, the outermost peripheral region of the static anterior optic 144 may have a first cross-sectional thickness. This peripheral region of the static anterior optic 144 can have a substantially vertical interior sidewall 1550 that defines a chamber 155. The central region of the static anterior optic 144 can have an interior sidewall 1550 that slopes away from vertical toward the dynamic membrane 143. The cross-sectional thickness of the static anterior optic 144 decreases in the center to approach the cross-sectional thickness of the dynamic membrane 143.

[0029] The diameter of the dynamic membrane 143 can vary and can differ depending on the shape of the sidewall 1550 that forms the chamber 155. As described above and shown in FIG. 2B, the inner sidewall 1550 formed by the static anterior optic portion 144 can be substantially vertical (back to front) such that the angle between the sidewall 1550 and the inner surface of the dynamic membrane 143 is about 90 degrees. The diameter of the dynamic membrane 143 can be substantially the same as the diameter of the chamber 155, for example, about 2.5 mm to about 3.1 mm, or about 2.0 mm to about 4.0 mm. In another embodiment, the interior sidewall 1550 formed by the static anterior optic portion 144 may be substantially vertical in a first, more peripheral region forming a first portion of the chamber 155 having a height of about 50-500 microns, and the interior sidewall 1550 formed by the static anterior optic portion 144 may be sloped or angled in a second, more central region forming a second portion of the chamber 155 having a height of about 100-600 microns (see FIG. 3A). The angle between the sidewall 1550 and the interior surface of the dynamic membrane 143 in this embodiment may be greater than 90 degrees, such as about 130 degrees to about 170 degrees. The sloped interior surface of the static anterior optic portion 144 may result in the diameter of the dynamic membrane 143 being smaller than the diameter of the first portion of the chamber 155 where the walls of the static anterior optic portion 144 are vertical. For example, the diameter of the dynamic membrane can be from about 1.7 mm to about 3.0 mm, while the diameter of the first portion of the chamber 155 is from about 3.5 mm to about 5.0 mm.

[0030] The static anterior optic portion 144 can be about 300 to 700 microns thick from anterior to posterior at its outermost periphery. In contrast, the dynamic membrane 143 can be thinner. In some embodiments, the dynamic membrane 143 can be about 80 microns or less, or about 90 microns or less, or about 100 microns or less, or about 150 microns or less, or about 200 microns or less, and any thickness between these ranges at its thickest point. In some embodiments, the center of the dynamic membrane 143 has a greater thickness than the periphery of the dynamic membrane. For example, the center of the dynamic membrane 143 can be greater than 60 microns to about 80 microns, or to about 90 microns, or to about 100 microns, or to about 200 microns, and any thickness between these ranges. The periphery of the dynamic membrane can be thinner than the center, for example, by 10 to about 30 microns. In other embodiments, the periphery of the dynamic membrane 143 has a greater thickness than the center. In yet another embodiment, the center and periphery are thicker than the area of ​​membrane 143 between them.

[0031] The shapes of the chamber 155, the dynamic membrane 143, and the static anterior optic portion 144 can be designed in combination with the refractive index (RI) of the solid (e.g., silicone elastomer) and liquid (e.g., silicone oil) components of the lens. The external shape of the dynamic membrane 143 during shape change may be aspheric and does not have a single radius of curvature (see Figures 3E-3F). Rather, the local radius of curvature changes between the center of the membrane 143 and the periphery of the membrane 143. The change in curvature on the surface may form a transition zone 1437 where the curvature changes from convex to concave (see Figure 3F). The concavity of the curve can create optical aberrations that become more severe with a higher refractive index of the liquid component in the chamber. This aberration can be controlled by adjusting the RI of the components, but some aberrations can become too severe to be corrected. Thus, a membrane design that is aspheric and incorporates a transition zone in its curvature during shape change is preferably used with a liquid component that has a lower RI than the RI of the solid component. In those cases where a transition zone is incorporated, it is advantageous to limit the width of the transition zone.

[0032] Other membrane designs can have an external shape during shape change that is substantially spherical and has a single radius of curvature between the center of the membrane 143 and the periphery of the membrane 143 (see Figures 3G-3H). The internal curvature between the solid and liquid components of the lens forms a diverging lens when the liquid component has a lower RI than the RI of the solid component which affects the optical quality (see Figures 3I-1 and 3I-2). Figure 3I-1 is an image of a pre-membrane using an optical measurement device to evaluate the optical quality of a lens with solid and liquid components when the RI of the liquid component is lower than the RI of the solid component. The optical quality is often characterized as the modulation transfer function (MTF) and can be measured using an IOLA-Multifocal Diffractive (Rotlex, Israel). The parallel or substantially parallel lines shown in Figure 3I-1 indicate good optical quality, while a distorted image indicates poor optical quality. FIG. 3I-2 shows the lens of FIG. 3I-1 in schematic form, with light rays (arrows) passing through the membrane 143 and diverging as they enter the liquid component. Light beams near the central region (solid arrows) where there is no internal curvature are nearly unaffected upon entering the liquid component. Light beams where there is internal curvature (dotted arrows) will form diverging lenses if the oil is poorly matched, adversely affecting optical quality. The relative refractive index of the materials affects optical quality. In contrast, the internal curvature between the solid and liquid components of the lens will form no lens or a converging lens without affecting optical quality if the liquid component is index-matched or over-matched to the RI of the solid component (see FIGS. 3J-1 and 3J-2). FIG. 3J-1 is an image of a pre-membrane using an optical metrology device to evaluate the optical quality of a lens with a solid and liquid component, where the liquid component has an RI that is index-matched to the RI of the solid component. Figure 3J-2 shows a schematic of the lens of Figure 3J-1, with light rays (arrows) passing through membrane 143 and incident on the liquid component where they converge. Light rays near the central region where there is no internal curvature and light rays where there is internal curvature do not form a lens if the oil is overmatched and form a converging lens if the oil is index matched.

[0033] The intraocular lenses described herein are preferably formed of materials configured for small incision implantation. The solid optical components of the lenses can have elastomeric properties, be optically clear, be biocompatible, and can be made of flexible soft silicone polymers with a sufficiently low Young's modulus to allow the lens body to change its degree of curvature during accommodation in certain circumstances. It should be understood that some solid optical components have a different Young's modulus than other solid optical components to provide different functions to the lens (e.g., a dynamic membrane 143 that bows outward during accommodation compared to a stationary anterior optical portion 144 that relaxes strain during accommodation). Materials suitable for the solid optical components of the lenses can include, but are not limited to, silicones (e.g., alkyl siloxanes, phenyl siloxanes, fluorinated siloxanes, combinations / copolymers thereof), acrylics (e.g., alkyl acrylates, fluoroacrylates, phenyl acrylates, combinations / copolymers thereof), urethanes, elastomers, plastics, combinations thereof, and the like. In some embodiments, the solid optical components of the lenses are formed of silicone elastomers as described herein. The solid optical component may be formed of one or a combination of the materials described herein, where the liquid optical material described herein is fully encapsulated by the solid optical component. The solid optical component of the lens may include one or more regions configured to contact and / or contain the liquid optical material. The liquid optical material described herein may be specially formulated with respect to the material of the solid optical component to mitigate instability and optimize optical quality of the lens. The liquid optical material, sometimes referred to herein as an optical fluid, may include any of a variety of copolymers, including fluorosilicone copolymers and other liquid optical materials, as described in PCT Application No. PCT / US2021 / 37354, filed June 15, 2021, which is incorporated herein by reference in its entirety.

[0034] 4A-4H show an embodiment of a lens 100 having a solid optical component and a liquid optical material. The solid optical component can include a lens body 105 formed by any of the various components including the anterior optic 145 and the posterior static element 150 described above. A sealed fixed volume fluid chamber 155 defined by the lens body 105 can contain a fixed volume of liquid optical material. The lens 100 can include an anterior optic having a central dynamic zone or shape-changing membrane 143 surrounded by a static anterior optic portion 144 at the periphery of the anterior optic. The dynamic membrane 143 can be configured to undergo a shape change while the static anterior optic portion 144 can be configured to resist or not undergo a shape change. The static element 150, which can be a static lens, can similarly not undergo a shape change. The cross-sectional shapes of the static anterior optic portion 144 and the dynamic membrane 143 can vary as described above. Where the cross-sectional thickness of the membrane appears uniform in the figures, it should be understood that the thickness can vary as discussed elsewhere herein.

[0035] The equatorial region of the lens body 105 may include at least one shape-deforming membrane 140 (best shown in FIG. 4E). The inner surface of the anterior optic 145, the dynamic membrane 143, the static anterior optical portion 144 of the anterior optic 145, the shape-deforming membrane 140, and the static element 150 may collectively form a fixed volume fluid chamber 155. The components defining the fluid chamber 155 may be solid optical components, and the fixed volume of material contained within the fluid chamber 155 may be liquid optical material. The shape-deforming membrane 140 may be disposed adjacent to at least one force translation arm 115. As described in more detail below, movement of the force translation arm 115 causes movement of the shape-deforming membrane 140, thereby deforming the liquid optical material and the fluid chamber 155, causing a change in shape of the dynamic membrane 143 of the lens body 105. The anterior optic 145 may be molded as a single piece of polymer material including the dynamic membrane 143, the static anterior optic portion 144, the shape-changing membrane 140, and the force conversion arm 115. Thus, the shape-changing membrane 140 and its associated force conversion arm 115 may be molded together as an integral part of the anterior optic 145. Any of the various lens components may be integrally molded or may be bonded together, such as with an adhesive or other bonding material. The lens may have minimal adhesive or bonding surfaces. In an embodiment, one or more lens components are bonded together by chemical bonding rather than non-chemical bonding with an adhesive.

[0036] 4A, the anterior optic 145 can be a flexible optic formed of an optically clear low modulus polymeric material such as silicone, polyurethane, or flexible acrylic. The anterior optic 145 can include a static anterior optic portion 144 surrounding a central dynamic membrane 143 configured to deflect outwardly, as discussed elsewhere herein. The dynamic membrane 143 can be positioned relative to the lens body 105 such that the optical axis A of the lens extends through the dynamic membrane 143. The anterior optic 145 can have a variable thickness. For example, the dynamic membrane 143 can have a reduced thickness compared to the static anterior optic portion 144. The reduced cross-sectional thickness of the dynamic membrane 143 compared to the cross-sectional thickness of the static anterior optic portion 144 allows the dynamic membrane 143 to fold relatively easily when a force is applied to its inner surface. For example, as the force exerted against the inner surface of the anterior optic 145 during deformation of the fluid chamber 155 increases, the dynamic membrane 143 bends outwardly along the optical axis A of the lens 100 while the static anterior optic portion 144 maintains its shape. The dynamic membrane 143 can be configured to cause an outward bowing of the outer surface (e.g., the anterior surface) due to pressure exerted on the inner surface of the anterior optic 145 by the liquid optical material in the fluid chamber 155. The outer static anterior optic portion 144 of the anterior optic 145 can have a greater thickness than the inner dynamic membrane 143 of the optic 145 and can be more resistant to reshaping under such internal pressure exerted by the liquid optical material in the fluid chamber 155. The outer static anterior optic portion 144 of the anterior optic 145 can provide correction for distance vision even when the inner dynamic membrane 143 reshapes for near vision.

[0037] The dynamic membrane 143 can have a substantially constant thickness as a planar element. Preferably, the dynamic membrane 143 can have a variable thickness between its outermost edge and a central region, as discussed in more detail above and shown in Figures 2B, 3A-3D. The dynamic membrane 143 can have a linear gradient thickness, a curved gradient thickness, two, three or more thicknesses with steps including radial or right angles.

[0038] The dynamic membrane 143 may also include multiple materials, for example, materials configured to flex near the center of the dynamic membrane 143 and other materials configured to reinforce the optic zone to limit distortion. Thus, the dynamic membrane 143 of the anterior optic 145 may be formed of a material that is relatively more susceptible to outward bowing than the material of the outer static anterior optic portion 144. Various regions of the optic 145 may be injection or compression molded to provide a relatively seamless, uninterrupted outer surface. The dynamic membrane 143 may have different stiffness or elasticity that causes it to bow outward more than the static anterior optic portion 144, although the material of each region may be generally consistent.

[0039] The anterior optic 145 can be configured with various multifocal capabilities to provide the wearer of the lenses described herein with enhanced vision over a wider distance range, for example, as described in U.S. Publication No. 2009 / 0234449, which is incorporated herein by reference in its entirety. The term "optic zone" as used herein generally refers to a region of the lens body 105 that surrounds the optical axis A of the lens and is optically clear for vision. The term "accommodative zone" as used herein generally refers to a region of the lens body 105 that can undergo a shape change for focusing (e.g., dynamic membrane 143). Although the optic zone is configured to have a corrective power, the entire optic zone does not necessarily have the same corrective power. For example, the dynamic membrane 143 and the static anterior optic portion 144 of the anterior optic may each be disposed within an optic zone. The dynamic membrane 143 may have a corrective power, while the static anterior optic portion 144 may not have a corrective power. Alternatively, for example, the diameter defined by the dynamic membrane 143 may have an optical power and the static anterior optic portion 144 may have a power greater or less than that of the dynamic membrane 143. The dynamic membrane 143 may be equal to or smaller than the overall optic zone, creating a multifocal lens. The accommodative zone of the lens body 105 may be equal to or smaller than the overall optic zone.

[0040] The shape-changing membrane 140 can extend along an arc length of the equatorial region of the lens body 105. The arc can be long enough, alone or in combination with other shape-changing membranes 140, to cause a responsive shape change in the dynamic membrane 143 upon inward (or outward) movement of the shape-changing membrane 140. Movement of the shape-changing membrane 140 generally inward toward the optical axis A of the lens 100 during accommodation can cause an outward deflection or bowing of the dynamic membrane 143 without affecting the overall optic zone diameter in any axis.

[0041] The shape-changing membrane 140 can be movable and flexible such that it can undergo displacement relative to the lens body 105, the static element 150, and the anterior optic 145. For example, the shape-changing membrane 140 can be more flexible than adjacent regions of the lens body 105 such that it can be selectively moved relative to the lens body 105 and the static anterior optical portion 144 of the anterior optic 145. The shape-changing membrane 140 can have a rest position. The rest position of the shape-changing membrane 140 can vary. In some embodiments, the rest position is when the shape-changing membrane 140 is disposed generally perpendicular to a plane parallel to the anterior optic 145 such that it has a vertically oriented cross-sectional shape parallel to the optical axis A. The shape and relative position of the one or more side deformation membranes 140 provide the lens with high accommodation with low force, low displacement.

[0042] The movement of the shape-changing membrane 140 may be other types of movement such as compression, collapse, indentation, stretching, deformation, deflection, displacement, hinging, etc., and moves in a first direction (e.g., generally toward the optical axis A of the lens body 105) when a force is applied to the shape-changing membrane 140.

[0043] The shape-changing membrane 140 is adjacent to, connected to, or integrally formed with each of the force-transforming arms 115. The force-transforming arms 115 are configured to utilize the movement of one or more ciliary body structures to be bidirectionally movable relative to the lens body 105 to effect an accommodative shape change of the lens body 105. For example, without limiting the disclosure to a particular theory or mode of operation, the ciliary muscle 18 is substantially a ring-shaped structure or sphincter. In a natural situation, when the eye looks at a distant object, the ciliary muscle 18 in the ciliary body relaxes and the inner diameter of the ciliary muscle 18 increases. The ciliary process pulls the zonule 20, which pulls the lens capsule 22 near its equator. This causes the lens to become flattened or less convex, which is called disaccommodation. During accommodation, the ciliary muscle 18 contracts and the inner diameter of the ring formed by the ciliary muscle 18 (ciliary ring diameter, CRD) becomes smaller. The ciliary processes release tension on the zonules 20, allowing the natural lens to spring back to its natural, more convex shape and the eye to focus at near distances. This inward / anterior movement of the ciliary muscle 18 (or one or more ciliary structures) can be harnessed by the force transducer arm 115 to cause a shape change in the lens body 105.

[0044] In some embodiments, when the force transformation arm 115 is moved inward toward the optical axis A of the lens 100 by ciliary muscle contraction, the force transformation arm 115 impinges on the outer surface of the shape-changing membrane 140 and exerts a force against the outer surface. Thus, the contact between the shape-changing membrane 140 and the force transformation arm 115 can be a reversible contact such that upon ciliary muscle contraction, the force transformation arm 115 is biased against the outer surface in contact with the membrane 140, biasing the membrane 140 inward. When the ciliary muscle relaxes, the shape-changing membrane 140 returns to its rest position and the force transformation arm 115 returns to its rest position. The elastomeric nature of the moving components (i.e., the dynamic membrane and / or the shape-changing membrane) can cause the force transformation arm 115 to return to its rest position. In some embodiments, and as best shown in FIG. 4E, the shape-changing membrane 140 is coupled to or integral with the respective force transformation arm 115. As with other embodiments, upon ciliary muscle contraction, the force transducer arm 115 and shape-changing membrane 140 move cooperatively from a resting position to a generally inwardly displaced position causing a shape change in the dynamic membrane 143. The displacement of the force transducer arm 115 and associated shape-changing membrane 140 exerts a compressive force on the fluid chamber, thereby deforming the chamber and causing the dynamic membrane 143 to bulge outward.

[0045] The inward motion of the force transforming arm 115 and the associated shape deformation membrane 140 may be coaxial with an axis that is substantially orthogonal or perpendicular to the optical axis A. That is, the angle between the motion axis and the optical axis may be 90 degrees plus or minus about 1 degree, about 2 degrees, about 3 degrees, about 4 degrees, or up to about 5 degrees. It should be understood that a compressive force applied to the force transforming arm 115 by a ciliary body structure or the like may result in a radially inward motion that is not completely orthogonal to the optical axis A, and some angle values ​​greater than or less than 90 degrees are considered herein. The angle between the motion axis of the deformation membrane 140 and the optical axis A may also be substantially non-orthogonal or non-perpendicular. For example, the deformation membrane 140 may be compressed along an axis that is non-orthogonal to the optical axis A.

[0046] The number and arc length of each deformation membrane 140 may vary and depend on the overall diameter and thickness of the device, the internal volume, the refractive index of the material, etc. In general, the lens body has sufficient rigidity and bulk to be handled and manipulated during implantation, while the deformation membrane 140 has sufficient flexibility to allow the force conversion arm to change the shape of the fluid chamber 155. Depending on the overall diameter and thickness of the lens 100, the arc length of the shape deformation membrane 140 can be at least about 2 mm to about 8 mm. In some embodiments, the lens has a single shape deformation membrane 140 with an arc length between about 2 mm and about 8 mm. The single shape deformation membrane 140 may be designed to move between about 10 μm to about 100 μm upon application of a force as low as about 0.1 grams of force (gf) to achieve at least 1D, or 1.5D, or 2D, or 2.5D, or 3D change of the dynamic membrane 143. In some embodiments, the intraocular lens can have two opposing shape-changing membranes 140, each having an arc length between about 3 mm and about 5 mm, designed to move between about 25 μm and about 100 μm, respectively, upon application of about 0.25 gf to 1.0 gf, and can achieve at least a 1D change in dynamic membrane 143.

[0047] The shape-changing membrane 140 may move or collapse relative to the rest of the lens body when a certain amount of compressive force is applied. In general, intraocular lenses are designed such that very small forces (including not only applying compressive force toward the optical axis A but also releasing the compressive force) cause a movement in the order of microns sufficient to cause a sufficient power change with reliable optics. The compressive force applied to achieve the outward movement of the dynamic membrane 143 of the lens body 105 to allow accommodation can be as low as about 0.1 grams of force (gf). In some embodiments, the applied compressive force can be between about 0.1 gf and about 5.0 gf, or between about 0.25 gf and about 1.0 gf, or between about 1.0 gf and about 1.5 gf. Depending on the compressive force applied to achieve accommodation, the movement of the deformable region of the lens body 105 (e.g., the shape-changing membrane 140) relative to the central portion of the lens body 105 (e.g., the dynamic membrane 143) can be as small as about 50 μm. The relative movement of the shape-deforming membrane 140 of the lens body relative to the dynamic membrane 143 in response to an applied compressive force can be between about 50 μm and about 500 μm, between about 50 μm and about 100 μm, between about 50 μm and about 150 μm, or between about 100 μm and about 150 μm. The range of applied compressive forces (e.g., about 0.1 gf to about 1 gf) that result in these ranges of movement in the shape-deforming membrane 140 (e.g., 50 μm to 100 μm) can provide the devices described herein with accommodation capabilities that are within a dynamic range of at least greater than ±1D, and preferably greater than about ±3 diopters (D). In some embodiments, the diopter is between ±4D to ±6D for a movement of about 100 to 150 μm. The devices described herein can have an adjustment range of at least ±1D for about 100 μm of movement of the shape-changing membrane 140 and at least 0.25 gf of compressive force applied to the shape-changing membrane 140 in a substantially inward direction toward the optical axis A. In some embodiments, the devices can have an adjustment range of at least ±3D for about 100 μm of movement and at least about 1.0 gf. In some embodiments, the devices can have an adjustment range of at least ±3D for about 50 μm of movement and at least about 0.1 gf.

[0048] The micron motions described herein can be asymmetric micron motions (e.g., from one side of the device), symmetric micron motions from opposing sides of the device, or evenly distributed around the device relative to the optical axis. Whether the micron motions are asymmetric or symmetric, the outward bow of the dynamic membrane 143 achieved can be substantially spherical. The micron motions described herein can also be collective collective motions of the shape-changing membranes 140. Thus, if the lens 100 includes a single shape-changing membrane 140, that single membrane is capable of the desired micron motion (e.g., 50 μm to 100 μm) to achieve the desired power change (e.g., at least 1D to about 3D change). If the lens 100 includes two shape-changing membranes 140, the membranes together can achieve 50 μm to 100 μm of movement to achieve at least 1D of power change. The power change achieved by the devices described herein can be at least about 1D to up to about 5D or 6D of change. In some embodiments, the power change can be between 7D and 10D, for example, for patients with macular degeneration.

[0049] As mentioned above, and continuing with reference to Figures 4A-4G, the lens body 105 may include a static element 150. The static element 150 and the front optic 145 may be positioned opposite one another along the optical axis A of the lens 100. The static element 150 may be positioned on the exterior of the lens body 105 such that the flat surface 151 forms an interior surface facing the fluid chamber 155 of the lens body 105 and the curved surface 152 is in contact with the ocular fluid. Alternatively, the static element 150 may be positioned on the interior of the lens body 105 such that the flat surface 151 is in contact with the ocular fluid and the curved surface 152 forms an interior surface facing the fluid chamber 155 of the lens body 105.

[0050] The static element 150 is optically clear and can provide a support function without affecting the optics of the lens 100. Thus, the static element 150 can be zero power and can form a posterior support for the lens body 105. The static element 150 can be formed of silicone, urethane, acrylic material, low modulus elastomer, or combinations thereof. The static element 150 can be or include a static optic for correction to an emmetropic state, or can be of a power appropriate for aphakic patients (usually ±10D to ±30D). Thus, the static element 150 can have no optical power, up to about ±30D. When the lens 100 is used in combination with another capsule lens (e.g., as a "piggyback" lens), it can have a power ranging from about -5D to about +5D to correct for residual refractive or other optical aberrations in the optics of the eye. Static element 150 can be plano-convex, convex-plano, convex-convex, concave-convex, or any other combination. Static element 150 (or a lens disposed behind it) can be a toric lens, a spherical lens, an aspheric lens, a diffractive lens, or any combination of both, for example, to reduce or compensate for aberrations associated with flexible lenses. The relative refractive indices of static element 150 and the fluid surrounding it (whether it be the fluid of the eye or the liquid optical material in fluid chamber 155) determine the power of static element 150 for any given shape.

[0051] The lens 100 may include any of various combinations of reinforcements and / or supports to provide mechanical stability to the assembled lens 100. For example, the reinforcements may be provided in the peripheral regions of the front lens 145 and / or the static element 150. The reinforcement structures may be optically transparent or opaque. The reinforcement structures may be formed of rigid polymers, including but not limited to silicone, polyurethane, PMMA, PVDF, PDMS, polyamide, polyimide, polypropylene, polycarbonate, and the like, or combinations thereof. Other regions of the lens 100 may include one or more reinforcements or supports as well. In some embodiments, the one or more supports may be positioned external to the fluid chamber 155 such that the supports surround at least an outer portion of the lens body 105. For example, the external support may be a generally annular element that extends around the periphery of the lens body 105 and may have a central opening through which at least the dynamic membrane 143 of the front optic 145 is aligned such that the dynamic membrane 143 is outwardly deformable.

[0052] In some embodiments, the lens 100 includes one or more internal supports disposed in one or more regions of the lens 100 configured to mechanically isolate the optics (front and back) from stresses imposed by other parts of the lens, such as the stabilization system 120 and / or the force conversion arm 115, to limit optical distortion. In general, the material and / or structure of the internal supports provide sufficient rigidity to mechanically isolate the optics, especially when the lens 100 is placed under stresses imposed by the stabilization system 120 or the force conversion arm 115. The internal supports can be immovable features (meaning features that do not participate in accommodation) configured to mechanically isolate and thereby prevent or mitigate optical distortion, even during movement of other lens components (e.g., haptics, force conversion arms, etc.). They provide support to ensure that the optical parts of the device, such as the dynamic membrane 143 and the anterior optic 143, do not undergo shape changes when the lens is placed under certain forces or stresses. The strength of the internal support relative to other portions of the lens 100, such as the shape changing membrane 140 and dynamic membrane 143, improves the durability of the lens during manipulation and handling during insertion.

[0053] As described in more detail below, the internal supports can be disposed within or facing the fluid chamber 155 of the lens body 105 and / or embedded in one or more regions of the solid optical component. The one or more internal supports can be placed on or embedded in a thickened portion on the inner side of the static anterior optic portion 144 of the outer anterior optic 145. The one or more internal supports can also be separate components coupled to or disposed within one or more regions of the lens. The one or more internal supports can be coupled to and / or embedded within the static anterior optic portion 144 of the anterior optic 145. The internal supports can be formed of a material (or materials) that is harder, thicker, and / or more rigid than the shape-changing membrane 140 or dynamic membrane 143 of the anterior optic 145 to prevent inadvertent movement of the moving parts of the device. Alternatively, the internal supports can be made of the same material as the shape-changing membrane 140 or dynamic membrane 143 of the front optic 145, with the mechanical isolation function being achieved by the shape of the support structure. The supports can be made of rigid polymers, including but not limited to silicone, polyurethane, PMMA, PVDF, PDMS, polyamide, polyimide, polypropylene, polycarbonate, etc., or combinations thereof. For example, the internal supports can be multiple silicones or combinations of silicones with rigid or semi-rigid skeletal inserts.

[0054] The internal supports can be formed in any of a variety of configurations, sizes, shapes, and / or materials. The internal supports can include a material embedded within the material of another portion of the anterior optic 145. The cross-sections of FIGS. 4E-4F show the internal supports 110e embedded within the outer static optical portion 144. The cross-section of the lens shown in FIG. 4G shows the top surface of the anterior optic 145, including the central dynamic membrane 143, cut away to expose the fluid chamber 155 and a number of connecting posts 112. These connecting posts 112 can be part of the anterior optic 145 or made from the same material as the anterior optic 145. These connecting posts 112 can be part of the rear scope 150. The connecting posts 112 can be used to connect the anterior optic 145 to the rear optic. In some implementations, these posts of different materials can support the optics of the lens. The posts 112 and the embedded supports 110e may be collectively referred to herein as simply the internal supports 110.

[0055] 4E, 4F, 4G, the embedded internal supports 110e can include one or more reinforcements or other components or materials embedded within the polymer of the anterior portion of the lens body 105. As an example, the embedded supports 110e can be a hard silicone material embedded in a soft silicone material of an otherwise solid portion of the lens. The embedded supports 110e can be any of a variety of materials provided herein, including, but not limited to, silicone, polyurethane, PMMA, PVDF, PDMS, polyamide, polyimide, polypropylene, polycarbonate, and the like, or combinations thereof. The embedded internal supports 110e can be relatively planar elements lying generally parallel to the central longitudinal plane of the lens 100. The outer region of each support 110 can be disposed adjacent to the equatorial region of the lens body 105 and extend inward toward the dynamic membrane 143 of the anterior optic 145. The outer region of the support 110e can be bonded to or integral with the equatorial region of the lens body 105, or the outer region of the support 110e can be spaced apart from the equatorial region. The support 110e can extend along the length of the peripheral region of the static anterior optic 144, but can be spaced apart from the equatorial region near where the deformation membrane 140 extends along the arc length of the equatorial region (see FIG. 4G). This space away from the deformation membrane 140 provides a tolerance for the deformation membrane 140 not to prematurely impinge or contact the support 110e or the outer static anterior optic 144 during the inward accommodation movement.

[0056] The connecting posts 112 may be relatively narrow separate structures made of a reinforcing material that are integrated, bonded, and / or otherwise positioned near the peripheral region 154 of the anterior optic 145. FIG. 4G shows the regions of the connecting posts 112 near the location of each deformation membrane 140. The connecting posts 112 may be spaced inwardly from each deformation membrane 140. Their positioning relative to the deformation membrane and their relatively narrow shape allow the deformation membrane 140 to move without risk of contact or disruption of deformation. FIG. 4G shows that each region of the connecting posts 112 has a pair of connecting posts 112 spaced apart from each other, as well as a distance away from the static anterior optic portion 144 away from the deformation membrane 140 with the embedded internal support 110e. The first embedded internal support 110e can extend along an arc length between each of the deformation membranes 140, and the second embedded internal support 110e can extend along an arc length between the deformation membranes 140 on the opposite side of the lens body 105. Although FIG. 4G shows that each region of the linking posts 112 has two linking posts 112, there can be only one linking post 112 near each deformation membrane 140, or there can be more than one linking post 112 near each deformation membrane 140. In general, the linking posts 112 can be narrower than the embedded supports 110e. The embedded internal supports 110e can extend along a larger arc length than each of the separate linking posts 112, such that they are generally longer, wider, and flatter than the linking posts 112. However, the embedded supports 110e can also take a more distinct shape within the material of the static anterior optic portion 144, so that they also form narrow, distinct support points rather than elongated support sections.

[0057] The distribution and spacing of the connecting posts 112 relative to the shape-changing membrane 140 can minimize contact with moving parts of the lens, whether near the stationary regions of the lens body 105 or near the central region of the lens body 105. The shape of the connecting posts 112 can also minimize or limit contact between the connecting posts 112 and the shape-changing membrane 140. For example, the outer regions of the connecting posts 112 can be chamfered near the equatorial region to allow inward movement of the shape-changing membrane 140 while avoiding contact between the membrane 140 and the periphery of the support. The chamfer can be a single chamfer having an angle between about 10-80 degrees. It should be understood that the periphery region of one or more supports may not include a chamfer. Contact between the shape-changing membrane 140 and one or more connecting posts 112 can be avoided in other ways than incorporating a chamfer. For example, one or more connecting posts 112 can be spaced a distance away from the shape-changing membrane 140 (e.g., along and / or away from the periphery) to avoid contact. The linking posts 112 may also have dimensions between their outer and inner regions that extend a distance toward the center of the lens body to provide stability and support, but generally stop short of the central dynamic membrane 143 of the anterior optic 145. In some embodiments, such as shown in FIG. 4G, the linking posts 112 substitute for the static anterior optic portion 144 at a location along the equator of the lens body 105 near the deformation membrane 140. Thus, the static anterior optic portion 144 extends only around the equator in the portion of the lens body 105 between the locations of the deformation membranes.

[0058] The connecting posts 112 can have different shapes and sizes to provide the overall shape to the fluid chamber 155. In some embodiments, the posts 112 can include separate thin struts of material that extend through the lens from anterior to posterior, interspersed between larger connecting posts 112. The narrow struts are located inside the optic zone of the lens, and the larger inner struts are located outside the optic zone, each located away from the movable solid components. The larger connecting posts located outside the optic zone can collectively provide the overall shape to the fluid chamber 155 that contains the liquid component. The thin struts of material interspersed between the larger inner struts can provide support within these large hallways or channels of the fluid chamber 155 formed by the larger struts.

[0059] As previously mentioned, the lens body 105 may include a sealed, fixed-volume fluid chamber 155 collectively formed by the inwardly facing surfaces of the shape-changing membrane 140, the anterior optic 145, and the static elements 150, which contains a fixed volume of liquid optical material. The inwardly facing surfaces of the one or more inner linking posts 112 as well as the inwardly facing surfaces of the dynamic membrane 143 of the static anterior optic 144 (with embedded supports 110e) and the anterior optic 145 also form part of the fluid chamber 155. Thus, the distribution, size, shape, and number of the one or more linking posts 112 and the static anterior optic 144 affect the overall shape of the fluid chamber 155 (see FIG. 4G).

[0060] Regardless of the configuration, the internal supports 110 (both the embedded supports 110e and the connecting posts 112) can limit inefficient lens motion in areas of the lens 100 other than where accommodative motion is desired. The internal supports 110 serve to concentrate all ciliary body induced pressures on the central dynamic membrane 143. The internal supports 110 mechanically isolate the dynamic regions of the lens 100 and structurally reinforce the non-dynamic regions of the lens 100, thereby concentrating shape changes only where they are desired for accommodation, namely the lateral deformation membrane 140 via the movement of the force transducer arms 115 and the dynamic membrane 143 from increased pressure in the fluid filled chamber 155. The shape and stiffness of the internal supports 110 serve to mechanically prevent other lens areas from deforming under the increased internal pressure of the fluid filled capsule.

[0061] The internal support 110 can be made of any of a variety of materials or combinations of materials that can be opaque or transparent, but is generally more rigid than the moving parts of the lens 100. In some embodiments, each solid part of the lens 100 is made of the same material, which provides advantages from a manufacturing standpoint. The material of the various solid parts may be the same (e.g., silicone), but the mechanical properties of the various solid parts differ depending on what function the part serves for the lens (i.e., shape change, force transmission, or centering and stabilization). One solid component of the lens may be more rigid than another component of the lens (e.g., the internal support 110 compared to the peripheral membrane 140), but both solid components may be of the same material. A more rigid solid part may be more rigid due to differences in the shape or dimensions of the part compared to a less rigid solid part. Thus, the internal support 110 and the membranes 140, 143 may be formed of the same silicone material, but the membranes 140, 143 have a significantly reduced thickness compared to the internal support 110, such that the membranes 140, 143 deform easily upon application of a compressive force, whereas the internal support 110 does not. In some embodiments, the internal support 110 may be a silicone elastomer (e.g., silicone PDMS 70-90 shore A) and the membranes 140, 143 may be a silicone elastomer (e.g., silicone PDMS 20-50 shore A). Additionally, the internal support 110 may include features that impart greater stiffness and rigidity to the membranes 140, 143.

[0062] The liquid optical material contained within the fluid chamber 155 can be an incompressible liquid optical material, and the volume of the fluid chamber 155 can be substantially the same as the volume of the liquid optical material. In this manner, the liquid optical material contained within the chamber 155 does not cause significant outward bowing of either the dynamic membrane 143 or the deforming membrane 140 in a rest state where no substantial external force is applied to the lens 100. In some embodiments, the fluid chamber 155 can be slightly overfilled with the liquid optical material such that the dynamic membrane 143 has some outward bowing in a rest state. The outward bowing of the dynamic membrane 143 at rest can reduce optical artifacts of the lens. However, whatever the degree of outward bowing of the dynamic membrane 143 at rest, the dynamic membrane 143 can undergo further outward bowing by applying a compressive force to the shape deforming membrane 140. The pressure inside the fluid chamber 155 can be substantially equal to the pressure outside the fluid chamber 155. Since the liquid optical material in the fluid chamber 155 is incompressible, its shape changes with the shape of the fluid chamber 155. The deformation of the chamber 155 at one location (e.g., the inward movement of the shape-changing membrane 140 on the order of microns) causes the incompressible liquid optical material contained within the fixed volume of the fluid chamber 155 to be pressed against the inwardly facing surface that forms the fluid chamber 155. A reactive deformation of the fluid chamber 155 occurs at a second location to produce a sufficient accommodation change. The dynamic membrane 143 of the anterior optic 145 is configured to deflect outwardly upon application of force (e.g., due to relative thickness and / or elasticity) compared to other portions of the anterior optic 145, such as the static anterior optic portion 144. Thus, the inward movement of the shape-changing membrane 140 causes the liquid optical material to deform with the chamber 155 and to be forced against the inwardly facing surface of the anterior optic 145. This results in the outer surface of dynamic membrane 143 reshaping outward, making the accommodative portion of the optic zone more convex and increasing the power of lens 100. As discussed above, internal supports 112, 110e provide sufficient stability to lens body 105 to exert a compressive force on shape-changing membrane 140 to induce micrometric movement with minimal distortion of the optical system.

[0063] The liquid optical material contained within the fluid chamber 155 of the lens body 105 remains substantially within the optic zone during rest, both in an unconditioned rest state and during accommodation. The liquid optical material remains within the lens body 105 and can contribute to the accommodative shape change of the dynamic membrane 143 by deforming its shape with the deformation of the shape of the fluid chamber 155. It should be understood that this shape change of the dynamic membrane 143 can occur without an actual flow of the liquid optical material within the fluid chamber 155, e.g., from one part of the chamber to another. Rather, a force applied to the shape-deforming membrane 140 deforms the fluid chamber 155 in a first region that can cause a reactive deformation of the fluid chamber 155 at least in a second region. The fluid chamber 155 has a fixed volume and is deformable. The liquid optical material contained within the fluid chamber 155 changes shape with and in response to the shape of the fluid chamber 155. With the incompressible liquid optical material in the fluid chamber 155 pressed against its inner surface, an inward deformation of one or more portions of the fluid chamber 155, e.g., the movement of the shape-changing membrane 140 near the static zone of the lens body 105, can cause a reactive outward deformation of another portion of the fluid chamber 155, e.g., the outward bulging of the dynamic membrane 143 of the anterior optic 145. The liquid optical material does not have to flow between separate chambers of the intraocular lens, but rather the liquid optical material changes shape with the change in shape of the fluid chamber 155, causing the accommodation portion of the optic zone of the anterior optic 145 to deflect outwardly, increasing the power of the intraocular lens 100. As described elsewhere herein, a very small movement of the force conversion arm 115 (or a single force conversion arm 115 in the case of an asymmetric mechanism) can instantly cause a small movement of the shape-changing membrane 140 to change the shape of the dynamic membrane 143, resulting in a sufficient power change. Whether these very small movements are symmetrical with at least a pair of opposing force transducer arms 115 or asymmetrical with a single force transducer arm 115, the outward deflection of the dynamic membrane 143 that is achieved is spherical and symmetrical.

[0064] The shape-changing membrane 140 is sensitive to small forces applied to the lens body 105. This is useful for changing accommodation in response to ciliary muscle movement. However, this can cause power changes with undesirable optical consequences if the liquid optical material moves away from the fluid chamber 155 and into, for example, the surrounding solid optical component 153. As discussed elsewhere herein, the liquid optical material is preferably sufficiently chemically dissimilar to prevent miscibility with the contacting solid optical component 153. For example, if the liquid optical material is silicone oil and the sealed chamber 155 is defined by a solid optical component 153 formed of a chemically similar silicone elastomer such as polydimethylsiloxane (PDMS), the silicone oil and the silicone elastomer are miscible. The oil tends to get into the silicone elastomer, causing an unintended change in the optical power of the lens. The surface curvature of the lens body is reduced (less convex, more concave), and the power of the lens is reduced, failing to provide sufficient optical power to the patient. This also reduces the lens's ability to undergo sufficient shape changes when needed during accommodation. Even small changes in internal pressure can result in undesirable changes in the optical power of the lens.

[0065] 4A-4H, the lens 100 may include one or more force conversion arms 115 configured to move back and forth relative to the lens body 105 to induce dioptric changes as described elsewhere herein. The lenses described herein are particularly suited to utilize ciliary movement applied directly to the force conversion arms 115 disposed against the ciliary structure to change the shape of the lens. The force conversion arms 115 are configured to utilize and convert the force applied by the ciliary structure to change the shape of the movable part of the lens body 105 as described above. Each force conversion arm 115 may include an outer contact portion 135 and an inner region 137 operably coupled to the periphery or equatorial region of the lens body 105 (see FIG. 4E). The inner region 137 of each force conversion arm 115 may be integral with, disposed in contact with, or adjacent to the shape change membrane 140 such that the force conversion arm 115 can move relative to the relaxed shape change membrane 140. For example, the force transformation arms 115 can be spaced apart from the membrane 140 when at rest, can move inward relative to the membrane 140 to urge the membrane 140 inward when accommodating, and can be spaced apart from the membrane 140 to release the force that would deform the membrane 140 inward when releasing accommodation. In this manner, the inner region 137 of the force transformation arms 115 can reversibly contact the shape-changing membrane 140 depending on whether an accommodative force is applied by the surrounding ocular tissue. Alternatively, the inner region 137 of each force transformation arm 115 can be physically coupled to or integral with the shape-changing membrane 140 such that the force transformation arms 115 and the membrane 140 move in concert with one another.

[0066] In some embodiments, the inner region 137 of the force conversion arm 115 has a cross-sectional thickness taken along a plane between the front surface of the lens body 105 and the rear surface of the lens body 105 that is narrower than the cross-sectional thickness of the equatorial region of the lens body 105 taken along the same plane. This allows the inner region 137 of the force conversion arm 115 to displace the deformation membrane 140 a distance inward without impinging against an area of ​​the equator that is not intended to be deformed. However, it should be understood that the cross-sectional thickness of the inner region 137 of the force conversion arm 115 does not have to be narrow. The outer contact portion 135 of the force conversion arm 115 can have a cross-sectional thickness greater than the inner region 137, but is not required to do so. However, it should be understood that the outer contact portion 135 of the force conversion arm 115 can also have the same cross-sectional thickness as the inner region 137. The outer contact portion 135 can also have a rounded or curved profile.

[0067] The force conversion arm 115 protrudes beyond the equator of the lens body 105 defining the first outer diameter D1 such that the outermost edge of the force conversion arm 115 defines a second outer diameter D2 that is substantially equal to or less than the inner diameter of the ciliary muscle (see FIG. 4H). The second outer diameter D2 may also be slightly larger than the inner diameter of the ciliary muscle. The first outer diameter D1 of the lens body 105 is smaller than the second outer diameter D2 of the force conversion arm 115. In one embodiment, the first outer diameter D1 may be between about 5.0 mm and about 9.0 mm, and the second outer diameter D2 may be between about 8.5 mm and about 13.5 mm. The first outer diameter D1 may be about 6.5 mm, and the second outer diameter D2 may be between about 10.2 mm and 11.1 mm.

[0068] The force conversion arms 115 of the lenses described herein are designed to contact the ciliary tissue providing a substantially non-circular circumferential surface. Thus, the contact area between the lens and the surrounding tissue is much smaller than, for example, a lens designed to be fully implanted in the capsular bag. Capsular bag lenses generally have a 360 degree contact with the bag to support the structure of the bag and maintain the distance between the anterior and posterior segments of the bag. Each force conversion arm 115 of the lenses described herein can contact the ciliary tissue from about 30 degrees to about 120 degrees. For lenses with two force conversion arms 115, the contact between the lens and the ciliary tissue is between about 60 degrees to about 240 degrees. In one embodiment, each force conversion arm 115 of the lens has a contact of about 90 degrees with the ciliary tissue and the contact of the entire lens with the surrounding ciliary tissue is about 180 degrees. The outer contact portion 135 of the force transformation arm 115 can provide contact with the surrounding ciliary tissue at about 240 degrees, about 210 degrees, about 180 degrees, about 150 degrees, about 120 degrees, about 90 degrees, up to a minimum of about 60 degrees of outer contact. The force transformation arm 115 can have a minimum contact along an arc of 2.5 mm and a maximum contact along an arc of about 6 mm, based on a ciliary process diameter of about 10.5 mm, such that the contact made by the force transformation arm 115 as a whole is about one third of the ciliary process.

[0069] The outer contact portion 135 of the force conversion arm 115 can be designed to contact the ciliary body tissue while minimizing contact with the posterior side of the iris. Bulking in this area of ​​the posterior chamber can increase the patient's risk of glaucoma. In one embodiment, the front corner of the force conversion arm 115 can be chamfered or tapered so that the thickness of the arm 115 from anterior to posterior decreases toward the outermost periphery compared to the more central region of the arm to minimize contact between the arm 115 and the iris (see FIG. 4D). The force conversion arm 115 can have an anterior-facing surface 116. The entire anterior-facing surface 116 of the force conversion arm 115 can remain below or posterior to the plane P1 of the anterior-facing surface 106 of the lens body 105. The chamfering of the front corners of the force conversion arms 115 may result in the outermost periphery of the arms 115 lying in a plane P3 posterior to the plane P2 of the inner region of the arms 115, and both planes P2, P3 lying posterior to the plane P1 of the anterior-facing surface 106 of the lens body 105, as shown in FIG. 4D. The arrangement of the lens body 105 and arms 115 minimizes contact between the outermost region of the intraocular lens and the iris, while maximizing the size of the lens body 105 near the inner region of the intraocular lens for shape change and accommodation. The outer contact portion 135 may have a relatively thin anterior-posterior dimension. The combination of the thin outer contact portion 135 and the small degree of contact with the ciliary body rim minimizes the overall contact surface area between the lens and the ocular tissue. The contact area between the lens and the ciliary body tissue may have an anterior-posterior thickness of about 0.4 mm to about 0.6 mm. The contact area between the lens and the ciliary tissue can have an arc length of about 2.5 mm to about 6.0 mm or less. Despite this small contact area, the lenses described herein can achieve minimal levels of shape change, as compared to, for example, in-the-bag style lenses.

[0070] The contact portion 135 of the force conversion arm 115 can incorporate features that improve connection with one or more of the ciliary structures without causing damage. Generally, the contact portion 135 avoids piercing or causing trauma to the ciliary structures. In some embodiments, the contact portion 135 can provide an atraumatic surface that engages with adjacent ocular tissue so as to transmit motion without trauma to the tissue itself while interfering with the ciliary structures. The outer contact portion 135 can also be shaped to have one or more recesses, indentations, grooves, teeth, combs, or other surface features to improve contact and / or interdigitation with ocular tissue, such as, for example, the ciliary processes or zonular processes. FIG. 4D shows that the underside of the force conversion arm 115 can have a contoured shape or surface features, such as a ridge 179. The arm 115 can have a posterior facing surface 117. An inner region of the posterior facing surface 117 near the equator of the lens body 105 can be substantially planar so as to lie substantially within the plane P4. The ridge 179 can be located near an outer region of the rear-facing surface 117 of the arm 115 that is distal to the equator of the lens body 105. The ridge 179 can project rearwardly in plane P4 relative to a planar inner region of the rear-facing surface 117. This feature improves contact between the arm 115 and the peripheral tissue.

[0071] The lens 100 is implanted such that the contact portion 135 of the force conversion arm 115 is in contact with at least one of the ciliary body structures (i.e., the zonules, the ciliary processes, the ciliary muscles, and / or the ciliary body) at rest or readily contacts upon contraction of the ciliary muscles 18, and can drive the shape change of the optical system during accommodation and release. In a preferred embodiment, the lens 100 is implanted such that the contact portion 135 of the force conversion arm 115 is in resting or preparatory contact with the ciliary body tip. In another preferred embodiment, the lens 100 is implanted such that the contact portion 135 of the force conversion arm 115 is in resting or preparatory contact with the ciliary body. In some embodiments, the lens 100 is sized to be generally oversized relative to the ciliary body structures. This can ensure contact between the force conversion arm 115 and the ciliary body structures during accommodation. In some embodiments, the lens is oversized by at least about 0.80 mm, 0.75 mm, 0.70 mm, 0.65 mm, 0.60 mm, 0.55 mm, or 0.05 mm to ensure contact between the force conversion arm 115 and the ciliary body. It should be understood that oversizing the lens is not necessary and may be avoided in some circumstances. For example, accurate measurement of the ciliary body diameter in the plane of the lens may be relied upon to ensure that the lens fit is appropriate and optimal for a particular patient.

[0072] The force conversion arm 115 described herein can have a fixed length. The fixed length force conversion arm 115 can have a size selected to be appropriate for each patient based on preoperative measurements. Alternatively, the length of the force conversion arm 115 can be adjustable. Adjustment of the length of the force conversion arm 115 can be performed at any time before, during, or after insertion into the eye. With adjustment of the length of the force conversion arm 115, the position of the force conversion arm 115 relative to one or more ciliary body structures can also change. In some embodiments, the force conversion arm 115 can extend generally parallel to the plane of the lens 100 or can be angled relative to the plane of the lens 100.

[0073] The ciliary muscle contracts toward the optical axis A of the lens 100, causing one or more ciliary structures to move inward / anteriorly, thereby exerting a force on the contact portion 135 of the force conversion arm 115. The force conversion arm 115 has sufficient rigidity with respect to the deformation membrane 140 to transmit the force exerted by one or more moving parts of the eye (e.g., one or more ciliary structures) to cause the deformation membrane 140 to move inward. In some embodiments, the force conversion arm 115 can be a hard polymer, such as silicone, polyurethane, PMMA, PVDF, PDMS, polyamide, polyimide, polypropylene, polycarbonate, etc., or a combination thereof. In some embodiments, the force conversion arm 115 can be an element reinforced with a rigid material. For example, the force conversion arm 115 can have an inner rigid element, such as a silicone elastomer, polyurethane, or flexible acrylic material, covered by a soft material, such as a silicone elastomer, polyurethane, PMMA, PVDF, PDMS, polyamide, polyimide, polypropylene, polycarbonate, etc., that is hydrophobic or hydrophilic. In silicone, polyurethane, PMMA, PVDF, PDMS, polyamide, polyimide, polypropylene, polycarbonate, the force conversion arm 115 may include an inner rigid element extending from the outer contact portion 135 to the inner contact portion 137. In silicone, polyurethane, PMMA, PVDF, PDMS, polyamide, polyimide, polypropylene, polycarbonate, the inner rigid element extends only along a partial length of the force conversion arm 115 between the outer portion 135 and the inner portion 137. For example, the inner rigid element does not need to extend specifically to the outer contact portion 135 where the force conversion arm 115 contacts the ciliary body structure in order to provide a softer, atraumatic surface so as not to damage the ciliary body structure. The inner rigid element also does not need to extend specifically to the inner contact portion 137 so that the inner rigid element of the force conversion arm 115 remains outside the lens body 105 upon inward movement of the shape deformation membrane 140 by the force conversion arm 115. In general, the force-transforming arm 115 is formed of a material and / or size such that it maintains its shape when a force is applied by the ciliary body structure and does not collapse or deform when transmitting that force to move the shape-changing membrane 140.As described above, movement of the shape-changing membrane 140 induces a shape change within the fluid chamber 155, changing the shape of the liquid optical material contained within the fluid chamber 155. As the liquid optical material is forced against the inner surface of the lens body 105, it causes an outward deflection of the dynamic membrane 143 of the anterior optic 145. This outward deflection causes the shape of the lens body 105 to become more spherical or convex, increasing the power of the lens for near focusing.

[0074] The number of force transforming arms 115 and shape-changing membranes 140 may vary. The lens 100 may include two force transforming arms 115 located on opposite sides of the device, lying adjacent to two shape-changing membranes 140, as shown in FIG. 4E. Alternatively, the lens 100 may include a single force transforming arm 115 that is movable in a manner sufficient to change the shape of the dynamic membrane 143 of the anterior optic 145 to achieve the desired power change. The lens 100 may also include more than two arms, such as three, four, or more force transforming arms 115 arranged around the lens body 105. The force transforming arms 115 may be arranged symmetrically or asymmetrically around the lens 100. It should be understood that the number of force transforming arms 115 does not have to match the number of shape-changing membranes 140. For example, the lens 100 may include a single shape-deforming membrane 140 that extends along an arc length of the equatorial region of the lens body 105, and multiple force-transforming arms 115 configured to contact or couple to different regions of the single shape-deforming membrane 140.

[0075] The lens 100 may also include a stabilization system 120. The stabilization system 120 may be configured to maintain alignment of the optics of the device and to resist movement of the device once the device is implanted and undergoes shape changes. Unlike the force conversion arm 115, the stabilization system 120 does not cause accommodation of the lens 100. And because the force conversion arm 115 is independent of the stabilization system 120 and does not need to fixate, center, stabilize, and / or hold the lens 100 in position within the eye, the lens 100 described herein may incorporate a single asymmetric force conversion arm 115 sufficient to provide dynamic membrane power changes.

[0076] The stabilization system 120 can be coupled to a static zone of the device 100, for example, glued, bonded, or molded as part of the lens body 105 or to an external support, if present. The stabilization system 120 can be coupled to a posterior region of the device 100 such that it can provide stabilization and engagement with a portion of the capsular bag, such as the anterior capsule.

[0077] The stabilization system 120 may vary. The stabilization system 120 may include one or more of stabilization haptics, static haptics, ring-like elements, flange elements or wings, or other stabilization features. The stabilization system 120 may include one or more wings 172 that extend outward from a region of the lens, such as the rear end (see, for example, FIG. 4C). The front surface of the ring-like structure 171 may be coupled to a peripheral connecting surface of the lens body 105 or the static element 150 such that the wings 172 extend to the rear side of the lens body 105. However, it should be understood that any of a variety of coupling arrangements between the stabilization system 120 and the lens body 105 are contemplated herein. The ring-like structure 171 and the wings 172 may be coupled to other portions of the lens body 105 or may be integral with other portions of the lens body 105. In general, the coupling of the stabilization system 120 to the lens body 105 is such that the wings 172 are disposed at a rearward position relative to the lens body 105 and the force conversion arm 115 along the optical axis A of the lens 100. Furthermore, the stabilization system 120 and its components, such as the wings 172, are coupled to the lens body 105 in a manner that does not impede the movement of the force conversion arm 115 and the shape-deforming membrane 140. For example, as shown in FIG. 4A, the stabilization system 120 can include a pair of wings 172 that extend outwardly from the periphery of the lens body 105 between the positions of the force conversion arm 115. The wings 172 can have an outer height, but are positioned at 90 degrees relative to the force conversion arm 115, so that they can provide stability without impeding the adjustment movement of the arm 115. Forces applied to the wings 172 or the ring-like structure 171 are not transferred by the stabilization system 120 to the lens 100 in a manner that would cause deformation of the fluid chamber 155 or a shape change of the dynamic membrane 143. The wing 172 can be disposed in a rearward position relative to the lens body 105 and the force conversion arm 115. The front surface of the wing 172 can also be flush with the force conversion arm 115. The more forward the wing 172 is, the more the wing 172 can push the lens body 105 in the rearward direction.In one embodiment, the wing 172 can bias the lens body 105 in a rearward lateral direction while remaining below the plane of the force conversion arm 115. FIG. 4D shows the wing 172 having an outer region that protrudes forward relative to an inner region 178 of the wing 172. The inner region 178 of the wing 172 can be below (or behind) the plane P1 of the lens body 105 and at the same time below (or behind) the planes P2, P3, P4, P5 of the force conversion arm 115 such that the inner region 178 is rearward relative to both the lens body 105 and the force conversion arm 115. The outer region of the forward protruding wing 172 can remain below the plane P1 of the front surface 106 of the lens body and below the planes P2, P3 of the front-facing surface 116 of the force conversion arm 115. In some implementations, the outer region of the forwardly projecting wings 172 can be located above, within, or below the plane P4 of the front-facing surface 117 of the force converting arm 115. The plane P5 of the protrusion 179 of the arm 115 can extend rearward relative to the outer height of the wings 172, as shown in FIG.

[0078] The wings 172 can extend beyond the outer diameter of the ring-like structure 171 in at least two regions along the circumference of the lens body 105. The at least two regions where the wings 172 extend beyond the outer diameter D1 of the lens body 105 can be oriented relative to the lens body 105 such that the wings 172 provide a stabilizing support for the force conversion arm 115. For example, if the lens 100 includes a pair of opposing force conversion arms 115, the wings 172 can be positioned relative to the lens body 105 such that the wings 172 extend outwardly from the lens body 105 between the positions of the opposing force conversion arms 115 and define an outer diameter D3 that is greater than the outer diameter D1 defined by the lens body and less than the outer diameter D2 defined by the force conversion arm 115 (see, for example, FIG. 4H). It should be understood that the wings 172 can have any of a variety of shapes, including oval, elliptical, cylindrical, and freeform. The wings 172 may also be annular, with an outer diameter D3 configured to extend outwardly beyond the outer diameter D1 of the lens body 105 along 360°. Alternatively, the wings 172 may have more than one point of extension beyond the outer diameter of the lens body 105, such as three, four, five, or more points. The wings 172 may provide 360° support and stabilization to the lens 100. The outer diameter D1 defined by the lens body may be sized to fit snugly within the opening of the capsule, for example, between about 5.0 mm and about 9.0 mm, preferably between about 6.5 mm. The outer diameter D2 defined by the force-transducing arm 115 may be sized to extend outside the capsule pouch to engage and utilize the ciliary body movement, for example, between about 8.5 mm and about 13.5 mm, or between about 10.2 mm and about 11.1 mm. The outer diameter D3 defined by the wings 172 can be sized to be received within the tunicate pouch so as to extend beyond the edge of the tunicate, for example, between about 6.0 mm and about 10.0 mm, preferably about 7.5 mm. In an embodiment, the first outer diameter D1 can be about 6.5 mm, the second outer diameter D2 can be between about 10.2 mm and 11.1 mm, and the third outer diameter D3 can be about 7.5 mm.

[0079] As mentioned above, the pair of wings 172 can be positioned between the positions of the force conversion arm 115 or rotated 90 degrees relative to the position of the force conversion arm 115. The outermost edge of the wings 172 can protrude forward such that a channel or groove 174 is formed near the inner region 178 of the wings 172 (see FIG. 4F). When the lens 100 is placed in the eye, the outer ridge of the wings 172 can engage with the rear-facing inner surface of the capsular bag (i.e., the anterior segment of the capsular bag) to help bias the lens 100 in a rearward direction against the capsular bag. Additionally, the edge of the capsule can be received and held within the groove 174. In some embodiments, the edge of the capsule can be captured between the groove 174 of the wings 172 and the rear-facing edge of the lens body 105. The groove 174 can define an outer diameter D4 that is narrower than the outer diameter D1 defined by the lens body 105 (see FIG. 4H). The presence of groove 174 and the small outer diameter D4 means that the capsular bag opening can be minimized. The larger outer diameter D1 of lens body 105 can remain in front of the bag opening so that the capsule in the bag only needs to encompass the small outer diameter D4 defined by groove 174. The outer diameter D3 defined by wings 172 can be larger than the size of the bag opening to prevent wings 172 from sliding in front of the bag opening once the intraocular lens is in place.

[0080] As described elsewhere herein, the force conversion arms 115 are configured to form a larger outer diameter D2 sized to extend outside the capsular bag 22 to engage with the ciliary body structure so that physiological forces from ciliary muscle contraction can cause changes in the optical power of the lens in a manner independent of the movement of the capsular mechanism or the capsular bag 22. The wings 172 extending outwardly from the posterior end region of the lens body 105 can define an outer diameter D3 sized to remain inside the capsular bag 22 posterior to the capsule, while the force conversion arms 115 extending generally from the equatorial or anterior end region of the lens body 105 define a larger outer diameter D2 sized to extend outside the capsular bag 22 to engage with the inner diameter of the ciliary body structure. The wings 172 can be positioned to engage a posterior-facing surface of the edge of the capsular bag 22 formed by the anterior capsule to improve fixation of the lens 100 in the eye. The edge of the capsule bag 22 formed by the capsule may be received in a groove 174 formed between the rear face of the lens element 105 and the front face of the wing 172. The groove 174 allows the edge of the capsule bag 22 to fit snugly against the smaller outer diameter D4 and be captured by the outer diameter D1 of the lens body 105 which may protrude in front of the opening of the bag 22. In this manner, the relative diameters of the lens body 105 and the groove 174 help to secure the position of the lens snugly against the capsule.

[0081] The wings 172 may have interruptions to provide flexibility during handling and to allow the surgeon to access the portion of the lens 100 and capsular bag 22 posterior to the wings 172. This may be preferred if the surgeon needs to clean the capsular bag, remove the viscoelastic, adjust the position of the lens, or perform other procedures in which the surgeon uses tools to manipulate the environment posterior to the lens. In some embodiments, the interruptions may include one or more openings that extend through the area of ​​the wings 172 (not shown). The interruptions may also include one or more indentations, or grooves or other features about the periphery of the wings 172. The interruptions may allow for easy insertion into the eye and may allow for natural drainage of fluids and / or withdrawal of the viscoelastic from within the capsular bag 22 using a cannula or other tools known in the art.

[0082] Referring again to FIG. 4C, the annular stabilizing structure 171 located on the rear side of the lens 100 can include a central opening 173 and a pair of wings 172 projecting outward from the annular stabilizing structure 171. In some embodiments, the lens 100 can incorporate two force conversion arms 115 and two wings 172. The wings 172 can be rotated 90 degrees on the circumference of the lens 100 relative to the two force conversion arms 115 so that they are located between them. This arrangement prevents the outer height of the wings 172 from interfering with the movement of the force conversion arms 115. FIG. 4B is a side view of the lens 100 showing the plane of the outer height of the wings 172 extending upward toward the plane of the force conversion arms 115. The inner region 178 of the wings 172 can be located in a plane that is located rearward of the planes P4, P5 of the rear-facing surface 117 of the arms 115 (see FIG. 4D). The wings 172 can be curved forward toward their periphery. The outer height plane of the wing 172 can be located rearward of the planes P4, P5 of the rear-facing surface 117 of the arm 115, or can extend above (or forward of) the planes P4, P5 of the rear-facing surface 117 of the arm 115 and below (or rearward of) the planes P2, P3 of the front-facing surface 116 of the arm 115, as shown in FIG. 4D.

[0083] The stabilizing structure 171 can be sized and shaped to engage with a corresponding surface of the lens body 105, such as the rear-facing surface of the rear element 150. It should be understood that the stabilizing structure 171 can be molded as an integral part of the lens body 105 and need not be a separate part. Thus, when surfaces of components are described as engaging or adhering to one another, it should be understood that this can include being molded together as a single piece.

[0084] The shape of the stabilizing structure 171 relative to the lens body 105 can improve fixation of the lens 100 within the capsular bag by capturing the edge of the capsule. The inner region 178 of the wing 172 can be spaced from the rear-facing edge of the lens body 105 forming a groove 174 between the lens body 105 and the inner region 178 of the wing 172 (see FIG. 4B). Although the lens stabilizing system 120 described herein is configured to be inserted into the capsular bag of the eye, the accommodation components of the lens (e.g., the force conversion arm 115 and the dynamic membrane 143) can extend outside the capsular bag. When the wings 172 are implanted within the capsular bag such that the outer height of the wings 172 engages the anterior portion of the capsular bag, the edge of the capsule can be received and held within the groove 174. The shape of the stabilizing structure 171 relative to the lens body 105 can also allow for fluid flow through the lens 100. For example, the bond between the stabilizing structure 171 and the lens body 105 can be discontinuous such that the outer height of the wings 172 engage the rear-facing surface of the anterior segment of the pouch, allowing fluid trapped on the rear side of the lens 100 to escape from the capsule even if the capsule fits snugly within the outer periphery (outer diameter D1) of the lens body 105 and / or the smaller outer diameter D4 defined by the groove 174. The lens body 105 near the groove 174 can further incorporate one or more openings, slots, or cutouts 177 that extend through the sidewall of the lens body 105. In some embodiments, a first cutout 177 in the sidewall of the lens body 105 can be located above the inner region 178 of the first wing 172 and a second cutout 177 in the sidewall of the lens body 105 can be located above the inner region 178 of the second wing 172 (see FIG. 4B). The cutout 177 creates a fluid flow path (e.g., for evacuation of fluids such as viscoelastic within the capsular bag) from the posterior side of the lens 100 (e.g., located within the capsular bag) to the anterior side of the lens 100 (e.g., located within the anterior chamber) between the stabilizing structure 171 and the posterior element 150, through the cutout 177 (see arrow A in FIG. 4F). Thus, the lens 100 is prevented from completely sealing with the capsular bag, even if the bag fits snugly against the capsule. The size of the cutout 177 can vary.In some embodiments, the width of cutout 177 approaches the width of the inner region of wing 172. Cutout 177 allows for unimpeded fluid flow through lens 100 without affecting the stability of lens 100 during accommodative movements. Wing 172 can further incorporate one or more interruptions or openings as described above.

[0085] Any of the stabilization systems described herein can be positioned to be coaxial or coplanar with the force conversion arm 115, or, as described above with respect to the haptics, can be positioned along a different axis than the force conversion arm 115 such that the stabilization system 120 is offset from or angled relative to the force conversion arm 115. Similarly, the stabilization system 120 can be angled relative to the force conversion arm 115 such that at least a portion of the stabilization system 120 is away from the plane of the lens such that at least a portion of the stabilization system 120 lies in a different plane than another portion of the stabilization system.

[0086] It should be understood that any of the stabilization systems described herein may be formed from hydrophobic or hydrophilic silicone elastomers, polyurethanes, PMMA, PVDF, PDMS, polyamides, polyimides, polypropylene, polycarbonates, or flexible acrylic materials, or any combination of such materials. The stabilization system may have a soft body reinforced with a more rigid structure to provide the stabilization function while maintaining flexibility for insertion and manipulation.

[0087] One or more portions of the stabilization system 120 described herein may incorporate biting elements to improve fixation within the eye. In some embodiments, the stabilization system 120 includes haptics, and biting elements may be located near their ends to improve fixation of the haptics within the eye. The stabilization haptics may be any of a variety of haptic designs or combinations of haptic designs, including, but not limited to, open loop, closed loop, plate style, plate loop, monoblock-plate style, J-loop, C-loop, modified J-loop, multi-piece, single piece, angled, flat, offset, and the like. Haptics contemplated herein may include Rayner designed haptics (Rayner Intraocular Lenses Ltd, East Sussex, UK), NuLens designed haptics (NuLens Ltd., Israel), Staar lens designs (Staar Surgical, Monrovia, CA), and the like. In some embodiments, stabilization system 120 may be formed of a biocompatible polymer, such as silicone, polyurethane, PMMA, PVDF, PDMS, polyamide, polyimide, polypropylene, polycarbonate, PEEK, or a combination of such materials, with or without including one or more haptics or 360-degree wings. Stabilization system 120 may be formed of a foldable material or configured to be foldable. In some embodiments, stabilization system 120 is formed of a shape memory material.

[0088] The lenses described herein have improved internal and / or external mechanical stability resulting in more efficient shape change. The shape change is more efficient in that it occurs only where desired (i.e., at the shape-changing membrane 140 and dynamic membrane 143) without causing distortion or bulging elsewhere in the device that would eliminate the desired shape change. The efficiency of the shape change is due to the mechanical isolation of the moving parts, for example, by one or more supports providing the lens 100 with sufficient rigidity to mechanically isolate the moving parts and effectively and efficiently perform the shape change without inadvertently causing bulging or distortion elsewhere in the device. The inward-facing regions of the lenses 100 described herein have reduced angles, rounded edges, and fewer dead zones, which can improve the efficiency of the shape change achieved. These aspects, along with the controlled and continuous thickness gradient of the dynamic membrane from the periphery to the center, provide the desired and predictable optical surface deflection for near vision.

[0089] The various components and features of the lenses described herein can be incorporated in any of a variety of combinations. Thus, the description of a particular feature shown with respect to a particular drawing is not intended to be limiting in that the feature may be incorporated in another embodiment of the lenses described herein. For example, the lenses described herein can include a stabilization system incorporating one or more features of the stabilization system described herein. Furthermore, a lens having a stabilization system feature can be combined with any of the various features described with respect to, for example, the force conversion arm 115 or the shape deformation membrane 140.

[0090] Materials or combinations of materials suitable for preparing the various solid optical components of the devices disclosed herein are provided throughout. It is understood that other suitable materials are also contemplated. U.S. Patent Publication Nos. 2009 / 0234449, 2009 / 0292355, and 2012 / 0253459, each of which is incorporated herein by reference in its entirety, provide further examples of other materials suitable for forming certain components of the devices described herein. One or more solid optical components of the lens body 105 can be integral with one another in that they are formed of the same material. For example, the internal support 110e can be a thickened region of the static anterior optic portion 144 of the anterior optic 145. Similarly, the shape-changing membrane 140 can be integral with one another with specific physical properties, such as thickness and flexibility, to provide a desired function. Alternatively, one or more solid optical components of the lens body 105 can be bonded together by techniques known in the art. Thus, one or more solid optical components of the lens body 105 can be formed of the same or different materials. One or more of the support 110, the static front optic portion 144, the dynamic membrane 145, and the shape-changing membrane 140 can be formed of an optically clear, low modulus elastomer, such as a flexible inelastic film, such as silicone, urethane, flexible acrylic, or polyethylene, as well as a halogenated elastomer, such as a fluorosilicone elastomer. In some embodiments, the liquid optical material contained within the fluid chamber 155 can be a fluorosilicone oil, and the solid optical components forming the fluid chamber 155 (e.g., the shape-changing membrane 140, the static element 150, the support 110, the static front optic portion 144, and the inwardly facing surface of the dynamic membrane 143 of the front optic 145) are formed of a silicone elastomer. In some embodiments, the liquid optical material contained within the fluid chamber 155 is a silicone oil, and the solid optical components forming the fluid chamber 155 are formed of a fluorosilicone elastomer.In some embodiments, the liquid optical material contained within fluid chamber 155 is an aromatic or phenyl-substituted oil, such as a phenyl silicone oil, and the solid optical components forming fluid chamber 155 are formed of a halogenated silicone elastomer, such as a fluorosilicone elastomer. The combination of materials is selected to optimize lens stability, prevent swelling, and maintain an optimal refractive index.

[0091] In some embodiments, the force conversion arm 115 can be a rigid polymer formed of silicone, polyurethane, PMMA, PVDF, PDMS, polyamide, polyimide, polypropylene, polycarbonate, etc., or combinations thereof. In some embodiments, the force conversion arm 115 can be a PMMA reinforced element. In embodiments, the lens is formed of an all silicone material, including the posterior static element 150 and the force conversion arm 115. The stabilization system 120 can be formed of a more rigid silicone, or can be formed of or incorporate polyimide. For example, the stabilization haptics and wings 172 can be polyimide.

[0092] The lenses described herein can provide focusing forces over the full range of accommodation from far to near, and can accommodate and disaccommodate by mechanically and functionally interacting with ocular tissues normally used by natural lenses, such as the ciliary body, ciliary processes, and zonules. The devices described herein can include an accommodation mechanism including one or more force conversion arms configured to be placed in the eye to utilize the movement of one or more ciliary body structures and convert the movement into functional forces to drive the shape change of the lens body for accommodation and disaccommodation in a manner independent of the movement of the capsular bag. The lenses described herein can achieve optical power changes ranging from one degree (1D) to 3D, up to about 5D or 6D. The forces generated by these tissues are functionally translated into the devices described herein causing power changes to accommodate more effectively. The lenses described herein can further include a stabilization system separate from the accommodation mechanism, for example, configured to be placed in the capsular bag. The devices described herein avoid known problems that tend to occur due to capsular fibrosis, as described above. It should be understood that the devices described herein may be configured to utilize the movement of one or a combination of ciliary structures, including, but not limited to, the ciliary muscle, the ciliary body, the ciliary processes, and the ciliary zonules. For simplicity, the term "ciliary structure" may be used herein to refer to any one or more ciliary structures whose movement may be utilized by a force transducer arm to achieve lens accommodation.

[0093] The devices described herein can be implanted in the eye in place of a diseased natural lens. The devices can be implanted as an adjunct to a natural lens (phakic patients) or an intraocular lens previously implanted in the patient's capsular bag (pseudophakic patients). The lenses described herein can be used in combination with the intraocular lenses described in US2009 / 0234449, US2009 / 0292355, US2012 / 0253459, WO2015 / 148673, and WO2018 / 081595, each of which is incorporated herein by reference in its entirety. Thus, the lenses described herein can be used independently or as so-called "piggyback" lenses. Piggyback lenses can be used to correct residual refractive errors in phakic or pseudophakic eyes. Primary lenses used in place of natural lenses are generally thick and usually have a power ranging from ±10D to ±25D. Thicker, higher power lenses generally do not accommodate. In contrast, the auxiliary lens does not need to provide significant optical power to the system. The auxiliary lens is relatively thin compared to the primary lens and can undergo more accommodation. Shape changes and movements of a thin lens are generally more easily accomplished compared to a thick primary lens. The lenses described herein can be used independently and do not need to be used in combination as a piggyback lens with a natural lens or an implanted lens. One or more components of the lenses described herein can be configured to be positioned within the sulcus 16, in position relative to the ciliary process, within the capsular bag 22, or a combination thereof.

[0094] The devices and systems described herein may incorporate any of a variety of features. Elements or features of one embodiment of the devices and systems described herein, as well as elements or features of another embodiment of the devices and systems described herein, may be incorporated alternatively or in combination with various implants and features described in US2009 / 0234449, US2009 / 0292355, US2012 / 0253459, WO 2015 / 148673, and WO2018 / 081595, each of which is incorporated herein by reference in its entirety. For the sake of brevity, various combinations are contemplated herein, but an explicit description of each of those combinations may be omitted. The various devices may be implanted, positioned, adjusted, etc., according to a variety of different methods and using a variety of different devices and systems. The various devices may be adjusted at any time before, during, and after implantation. Some representative descriptions of how the various devices may be implanted and positioned are provided, although for the sake of brevity, an explicit description of each method for each implant or system may be omitted.

[0095] In some aspects, the description will be made with reference to the figures. However, certain aspects may be implemented without one or more of these specific details or in combination with other known methods and configurations. Numerous specific details, such as specific configurations, dimensions, steps, etc., are described herein to provide a thorough understanding of the embodiments. In other instances, well-known processes and manufacturing techniques have not been described in particular detail so as not to unnecessarily obscure the description. Throughout this specification, references to "one embodiment," "one aspect," "one implementation," "one aspect," etc., mean that the particular feature, structure, configuration, or characteristic described is included in at least one embodiment, aspect, or implementation. Thus, the appearance of the phrases "one embodiment," "one aspect," "one implementation," "one aspect," etc., in various locations throughout this specification do not necessarily refer to the same embodiment, aspect, or implementation. Furthermore, certain features, structures, configurations, or characteristics may be combined in any suitable manner in one or more implementations.

[0096] The use of relative terms throughout this specification may indicate relative positions or directions or orientations and is not intended to be limiting. For example, "distal" may indicate a first direction away from a reference point. Similarly, "proximal" may indicate a position in a second direction opposite to the first direction. The use of terms such as "anterior", "lateral", and "posterior", as well as "forward", "backward", "front", and "rear" are used to establish relative frames of reference and are not intended to limit the use or orientation of the devices described herein in various embodiments.

[0097] The term "about" refers to a range of values ​​including the specified value that would be considered reasonably similar to the specified value by one of ordinary skill in the art. In embodiments, about refers to within a range of standard deviation using measurements generally accepted in the art. In embodiments, about refers to a range covering ±10% of the specified value. In embodiments, about includes the specified value.

[0098] Although many specific details are described herein, these should not be construed as limitations on the scope of what is claimed or what may be claimed, but rather as descriptions of features specific to particular embodiments. Certain features described herein in the context of separate embodiments can also be implemented in combination in a single embodiment. Conversely, various features described in the context of a single embodiment can also be implemented in multiple embodiments separately or in any suitable subcombination. Furthermore, although features are described above as acting in a particular combination and may even be initially claimed as such, one or more features from the claimed combination may in some cases be excised from the combination, and the claimed combination may be directed to a subcombination or variation of the subcombination. Similarly, although operations are depicted in the drawings in a particular order, this should not be understood as requiring such operations to be performed in the particular order shown, or sequentially, or that all of the operations depicted be performed to achieve desired results. Only a few examples, embodiments, aspects, and implementations have been disclosed. Variations, modifications, and enhancements to the described examples and implementations, as well as other implementations, may be made based on the disclosed content.

[0099] In the above description and in the claims, phrases such as "at least one" or "one or more" may appear following a connectable list of elements or features. The term "and / or" may also appear in a list of two or more elements or features. Such phrases are intended to mean any of the listed elements or features individually, or any of the listed elements or features in combination with any of the other listed elements or features, unless otherwise implicitly or explicitly contradicted by the context in which it is used. For example, the phrases "at least one of A and B," "one or more of A and B," and "A and / or B" are each intended to mean "A alone, B alone, or A and B together." A similar interpretation is intended for lists containing more than two items. For example, the phrases "at least one of A, B, C," "one or more of A, B, C," and "A, B, and / or C" are each intended to mean "A alone, B alone, C alone, A and B together, A and C together, B and C together, or A, B and C together."

[0100] Use of the term "based on" above and in the claims is intended to mean "based at least in part on," in which case unrecited features or elements are also permitted.

Claims

1. 1. An accommodative intraocular lens comprising: an anterior optic located within an optic zone of the accommodative intraocular lens; and an incompressible optical fluid, The front optic is a central dynamic zone configured to undergo a shape change for an accommodation function including a dynamic membrane having a differential thickness gradient between a posterior surface and an anterior surface of the dynamic membrane; The dynamic membrane is a first thickness at a central portion of the dynamic membrane between the rear surface and the front surface; a second thickness between the rear surface and the front surface at a peripheral portion of the dynamic membrane surrounding the central portion; The first thickness is greater than the second thickness; The front optic also a peripheral static zone having a static anterior optic portion configured to resist any shape change; an incompressible optical fluid is contained within a fluid chamber defined in part by the posterior surface of the dynamic membrane and the static anterior optic portion, and compressing the fluid chamber in a first region causes a shape change in the central dynamic zone for accommodation; Accommodative intraocular lenses.

2. The curvature of the front surface of the dynamic membrane is convex and curves forward along the optical axis of the lens; and The curvature of the posterior surface of the dynamic membrane is concave and curves forward along the optical axis of the lens, or The curvature of the posterior surface of the dynamic membrane is convex and curves posteriorly along the optical axis of the lens, or The curvature of the rear surface of the dynamic membrane is a flat surface. The accommodative intraocular lens of claim 1 .

3. The curvature of the posterior surface of the dynamic membrane is single radius or aspheric. The accommodative intraocular lens of claim 2.

4. The curvature of the front surface of the dynamic membrane is a single radius or aspheric equation, The accommodative intraocular lens of claim 2.

5. The static anterior optic has a front surface having a curvature that is the same as or different from the curvature of the front surface of the dynamic membrane. The accommodative intraocular lens of claim 4.

6. The curvature of the posterior surface of the dynamic membrane is convex and curves posteriorly along the optical axis of the lens; the curvature of the anterior surface has an anterior radius of curvature that is greater than the anterior radius of curvature of the static anterior optic portion of the peripheral static zone; The accommodative intraocular lens of claim 1 .

7. Due to the thickness gradient, the cross-sectional thickness of the dynamic membrane changes abruptly from the periphery to the center. The accommodative intraocular lens of claim 1 .

8. The differential thickness gradient causes a gradual change in the cross-sectional thickness of the dynamic membrane from the periphery to the center. The accommodative intraocular lens of claim 1 .

9. The cross-sectional thickness of the dynamic membrane at the center is 5 to 30 microns thicker than the cross-sectional thickness of the dynamic membrane at the periphery. The accommodative intraocular lens of claim 1 .

10. The cross-sectional thickness of the dynamic membrane at the center is greater than 50 microns, up to about 70 microns, or up to about 80 microns, or up to about 90 microns, or up to about 100 microns, or up to about 200 microns. The accommodative intraocular lens of claim 1 .

11. The diameter of the dynamic membrane is about 2.0 mm to about 4.0 mm. The accommodative intraocular lens of claim 1 .

12. an inner sidewall formed by the static anterior optic portion is substantially vertical from the posterior to the anterior side, and an angle formed between the inner sidewall and the inner surface of the dynamic membrane is about 90 degrees; The accommodative intraocular lens of claim 1 .

13. The cross-sectional thickness of the static anterior optic is greater than the maximum cross-sectional thickness of the dynamic membrane. The accommodative intraocular lens of claim 1 .

14. The cross-sectional thickness of the static anterior optic is about 300 microns to 700 microns, and the maximum cross-sectional thickness of the dynamic membrane is about 80 microns or less, or about 90 microns or less, or about 100 microns or less, or about 150 microns or less, or about 200 microns or less. The accommodative intraocular lens of claim 13.

15. a lens body including a front optic and an incompressible optical fluid contained within a fluid chamber; at least one force transforming arm; Movement of the at least one force transducer arm deforms the fluid chamber and changes the shape of the central dynamic zone of the anterior optic. The accommodative intraocular lens of claim 1 .

16. At least one force transforming arm includes an inner region operatively coupled to an equatorial region of the lens body and an outer region opposite the inner region; the outer region includes a chamfered front corner, and the thickness of the at least one force converting arm in the outer region from front to rear is less than the thickness of the at least one force converting arm in a more central region from front to rear; The accommodative intraocular lens of claim 15.

17. a stabilization system including one or more wings extending outwardly from a region of the lens body and positioned posteriorly with respect to the lens body and with respect to the at least one force transforming arm with respect to the optical axis of the lens; the lens body includes one or more openings, slots, or cutouts extending through a sidewall of the lens body and positioned over an inner region of one or more wings to create a channel for fluid evacuation from the posterior side of the lens; The accommodative intraocular lens of claim 15.

18. One or both of the anterior curvature and posterior curvature control the differential thickness gradient across the dynamic membrane from the periphery to the center, providing a predictable deflection when deforming the central dynamic zone. The accommodative intraocular lens of claim 1 .

19. When the anterior optic is in a non-adjustable state prior to the shape change, both the anterior surface of the dynamic membrane and the posterior surface of the dynamic membrane are curved; The radius of curvature of the rear surface is different from the radius of curvature of the front surface. The accommodative intraocular lens of claim 1 .

Images