Variable thickness dynamic membrane for adjustable 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 - reference to prior art This application claims priority based on co - pending U.S. Provisional Application Serial No. 63 / 136,843, filed on January 13, 2021. The entire disclosure thereof is incorporated herein by reference.

Background Art

[0002] The eyes of a healthy and young person can focus on objects far or near as needed. The function of the eyeball to alternate between myopia and hyperopia is called accommodation. Accommodation occurs when the ciliary muscle contracts, releasing the remaining zonular tension applied to the equator of the capsular bag. By releasing the zonular tension, the intrinsic elasticity of the lens (crystalline lens) changes to a more spherical or globular shape, and the curvature of the lenticular surfaces increases on both the front and back sides.

[0003] The human eyeball 10 includes the cornea 12, iris 14, sulcus 16, ciliary muscle 18, zonule 20, and lens 21 housed within the encapsulating sac 22 (Figures 1A and 1C). Adaptation occurs when the ciliary muscle 18 contracts, releasing the tension of the resting zonule over the equatorial region of the encapsulating sac 22. The release of zonule tension causes the lens 21 to change to a more spherical or spherical shape due to its inherent elasticity, increasing the surface curvature of both the anterior and posterior lens surfaces 23 and 24. Furthermore, human lenses can suffer from one or more disorders that impair their function in the visual system. A common lens disorder is cataract, which is the opacification of the normally clear, natural crystalline lens matrix 26. Cataracts can be caused by aging, but can also be caused by genetics, diabetes, or trauma. Figure 1A shows a lens capsule containing a encapsulated sac 22 with an opaque, crystalline lens nucleus 26.

[0004] In cataract surgery, the patient's opaque, crystal-like lens is replaced with a clear lens implant or intraocular lens (IOL) 30. In conventional extracapsular cataract surgery, as depicted in Figure 1B, the crystal-like lens matrix 26 is removed along with the ligamentous connection to the ciliary body and ciliary muscle 18, leaving the thin walls of the anterior and posterior capsule intact. The crystal-like lens core is removed by phacoemulsification through a curved capsulorhexis, i.e., removal of the anterior portion 23 of the encapsulation, as shown in Figure 1B. Figure 1B shows a conventional three-piece intraocular lens 30 immediately after implantation in the encapsulation sac 22.

[0005] In the case of phakic intraocular lenses, it is known that lenses are implanted in combination to address refractive errors of the existing lens, or in the case of pseudophakic intraocular lens patients to improve the refractive results of the standard intraocular lens after cataract surgery. These "piggyback" intraocular lenses can be placed anterior to a previously implanted intraocular lens or natural lens, usually to correct high myopia, or to improve the refractive situation after cataract surgery in the case of pseudocataracts. Generally, these lenses are implanted in the ciliary sulcus and have poor accommodation. As shown in Figure 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. Figure 1C also shows the angle of the anterior chamber 25 of the eyeball.

[0006] Intraocular lenses (IOLs) are typically implanted after cataract removal. Generally, IOLs are made from foldable materials such as silicone or acrylic to minimize the incision size and improve patient recovery time. The most commonly used IOLs are monofocal lenses that provide a single focal length for distance vision. Adjustable intraocular lenses (AIOLs) have also been developed to provide adjustable focal length (or adaptability) that relies on the eye's natural ability to focus, as described in, for example, US2009 / 0234449, US2009 / 0292355, US2012 / 0253459, US10,258,805, and US2019 / 0269500, respectively, and these are incorporated herein by reference in their entirety. AIOLs are beneficial for patients who do not have cataracts but wish to reduce their reliance on eyeglasses and contact lenses to correct nearsightedness, farsightedness, and presbyopia. Intraocular lenses used to correct large errors in nearsightedness, farsightedness, and astigmatism are called "phakic intraocular lenses" and are implanted without removing the crystal-like lens. In some cases, even without cataracts, an aphakic intraocular lens (not a phakic intraocular lens) may be implanted through lens extraction and replacement surgery. In this surgery, the lens is removed and replaced in a process very similar to cataract surgery. Refractive lens replacement, like cataract surgery, involves lens replacement, a small incision in the eyeball for lens insertion, is performed under local anesthesia, and takes about 30 minutes.

[0007] Intraocular lenses, particularly adjustable intraocular lenses, can incorporate a fluid chamber containing liquid so that accommodation is achieved with the help of a fluid-actuated mechanism. Forces applied to a portion of the lens are transmitted through the liquid, deforming the flexible layers of the lens and altering the adjustable shape of the intraocular lens. For example, ciliary muscle movement of the eyeball can be utilized by components of the AIOL to facilitate shape change and accommodation. The AIOL can achieve a desired range of optical power or diopter (D) through changes in the shape of the optics using small forces (e.g., only 0.1–1.0 gram force (gf)) applied by ocular tissue. The AIOL provides reliable dioptric change by utilizing small forces. A chamber for containing liquid material, formed by flexible layers of elastomer material, can change the shape and, consequently, the power of the lens depending on the volume of the liquid. As the filling volume increases beyond the chamber volume, the flexible layers bulge outward, creating lenses with larger focal lengths.

[0008] There is a need in the art for improved flexible layers of shape-changing lenses that provide improved characteristics to patients who need them. This disclosure is directed to this and other important purposes. [Overview of the Initiative]

[0009] A tunable intraocular lens having an anterior optic is provided. The anterior optic includes a central dynamic zone configured to undergo shape change for accommodative function, having a dynamic membrane with a differential thickness gradient between the posterior and anterior surfaces of the dynamic membrane. The anterior optic also includes a peripheral static zone having a static anterior optical portion configured to resist 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. By compressing the fluid chamber in a first region, the shape of the central dynamic zone is changed, thereby providing accommodation.

[0010] The front surface of the dynamic film may be convex, and the rear surface may be flat. The front surface can control the thickness gradient of the dynamic film, and the gradient can change gradually between the periphery and the center of the dynamic film. The front surface of the dynamic film may have a convex curvature of a single radius or an aspheric equation. The static front optical portion may have a front surface with the same or different curvature as the convex curvature of the front surface of the dynamic film. The front surface of the dynamic film may be convex, and the rear surface may be convex. Both the front and rear surfaces can control the thickness gradient of the dynamic film, and the gradient can change abruptly between the periphery and the center of the dynamic film. The front surface of the dynamic film may have a convex curvature of a single radius or an aspheric equation. The rear surface of the dynamic film may have a convex curvature of a single radius or an aspheric equation. The static front optical portion may have a front surface with the same or different curvature as the convex curvature of the front surface of the dynamic film. The front surface of the dynamic film may be convex, and the rear surface may be concave. Both the front and rear surfaces control the thickness gradient of the dynamic film, allowing the gradient to gradually change between the periphery and the center of the dynamic film. The front surface of the dynamic film may have a convex curvature with a single radius or an aspherical equation. The rear surface of the dynamic film may have a concave curvature with a single radius or an aspherical equation. The static front optical portion may have a front surface with the same or different curvature as the convex curvature of the front surface of the dynamic film.

[0011] The front surface of the dynamic film is convex, and the rear surface of the dynamic film is convex at its periphery and flat near its center. At the periphery of the dynamic film, both the front and rear surfaces control the thickness gradient, while at the center, only the front surface controls the thickness gradient. The gradient may change nonlinearly between the periphery and the center of the dynamic film. The front surface of the dynamic film may have a convex curvature with a single radius or an aspherical equation. The rear surface near the periphery of the dynamic film may have a concave curvature with a single radius or an aspherical equation. The static front optical portion may have a front surface with the same or different curvature as the convex curvature of the front surface of the dynamic film near its periphery. The front surface of the tuned dynamic film can be spherical, and the optical fluid may have a refractive index higher than that of the front optic. The front surface of the tuned dynamic film is aspherical, and the optical fluid may have a refractive index lower than that of the front optic. [Brief explanation of the drawing]

[0012] These and other embodiments will be described in detail below with reference to the following drawings. In general, the drawings are illustrative and intended to be schematic representations, not to absolute or relative scale. The relative arrangement of features and elements has been modified for illustrative purposes.

[0013] [Figure 1A] Figure 1A is a cross-sectional perspective view of an eyeball with an opaque lens capsule. [Figure 1B] Figure 1B is a cross-sectional oblique view of the eyeball in Figure 1A, in which the encapsulation and lens matrix have been removed curvilinearly, and a conventional three-piece intraocular lens has been implanted. [Figure 1C] Figure 1C is a cross-sectional view of the anterior angle of the eyeball. [Figure 2A] Figure 2A is a schematic top view of an adjustable intraocular lens. [Figure 2B] Figure 2B is a cross-sectional view of an adjustable intraocular lens along line BB in Figure 2A. [Figure 3A] Figure 3A is a cross-sectional view of the lens shown in Figure 2B, illustrating various front optic shapes. [Figure 3B] Figure 3B is a cross-sectional view of the lens shown in Figure 2B, illustrating various front optic shapes. [Figure 3C] Figure 3C is a cross-sectional view of the lens shown in Figure 2B, illustrating various front optic shapes. [Figure 3D] Figure 3D is a cross-sectional view of the lens shown in Figure 2B, illustrating various front optic shapes. [Figure 3E] Figure 3E is a cross-sectional view of the lens illustrating the front optic shape. [Figure 3F] Figure 3F is a schematic diagram of the dynamic film of the lens shown in Figure 3E, and has an aspherical adjustment shape. [Figure 3G] Figure 3G is a cross-sectional view of the lens illustrating the front optic shape. [Figure 3H] Figure 3H is a schematic diagram of the dynamic membrane of the lens shown in Figure 3G, and has a spherical adjustment shape. [Figure 3I-1] Figure 3I-1 is an image of the anterior membrane, obtained using an optical measuring device to evaluate the optical quality of a lens having solid and liquid components when the RI of the liquid component is lower than that of the solid component. [Figure 3I-2] Figure 3I-2 is a schematic diagram of Figure 3I-1 showing light rays passing through the solid and fluid components of the lens. [Figure 3J-1] Figure 3J-1 is an image of the front layer of a lens having a solid component and a liquid component, obtained using an optical measuring device to evaluate the optical quality, where the liquid component has an RI that is coefficient-matched to the RI of the solid component. [Figure 3J-2] Figure 3J-2 is a schematic diagram of Figure 3J-1 showing light rays passing through the solid and fluid components of the lens. [Figure 4A] Figure 4A is a perspective view of the lens implantation. [Figure 4B] Figure 4B is a side view of the lens shown in Figure 4A. [Figure 4C] Figure 4C is a rear perspective view of the lens shown in Figure 4A. [Figure 4D] Figure 4D is a side view of the lens shown in Figure 4A. [Figure 4E] Figure 4E is a cross-sectional view of the lens of Figure 4A. [Figure 4F] Figure 4F is a cross-sectional view of the lens of Figure 4A. [Figure 4G] Figure 4G is a cross-sectional view of the lens of Figure 4A, showing the support structure of the lens. [Figure 4H] Figure 4H is a plan view of the lens of Figure 4A, showing the diameters of various elements of the lens.

Mode for Carrying Out the Invention

[0014] In a lens, particularly an intraocular lens (IOL), it is important to have a high-quality optical system that avoids stray light, glare, or unintentional reflections reaching the retina. Generally, a lens is designed optically so that light refracted at the lens surface reaches the retina. Light from the lens edge at the non-optical interface between the lens edge and the aqueous humor can cause common dysphotopsias in commercially available lenses known in the art. Dysphotopsias are troublesome for patients. Similarly, any interface between two materials with different refractive indices within the lens can cause light to reach the patient's retina in a way that disrupts clear and high-quality vision. By maintaining the predictable shape of the lens during its service life, particularly during and after a change in the shape of the lens, the correct optical power for properly focusing light on the patient's retina can be obtained.

[0015]

[0016] ​Figures 2A-2B schematically and partially illustrate tunable intraocular lenses, which generally include solid optical components and liquid optical materials. The lens 100 may 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 optical portion 144. The dynamic membrane 143 of the anterior optic 145 is configured to undergo shape changes for accommodative function, while the static anterior optical portion 144 of the anterior optic 145 is configured to resist shape changes. The dynamic membrane 143 may have a differential thickness gradient to provide precise control over the shape of the membrane 143 and the overall optical performance during shape changes. The dynamic membrane 143 may be designed to have different thickness gradients to provide different membrane shapes that offer the best optical performance for a particular AIOL. The thickness gradient across the dynamic film 143 can be defined by the curvature of the front (outer) surface 1430 and rear (inner) surface 1435 of the dynamic film 143, as well as, in some embodiments, the curvature of the front surface 1440 of the static front optical portion 144 (see Figure 3A). Specific combinations of the curvatures of the front surfaces 1430, 1440, and rear surface 1435 of the dynamic film 143 can provide improved optical quality.

[0017] As used herein, the terms “anterior” and “posterior” are used to indicate a relative frame of reference, position, direction, or orientation for the sake of understanding and clarity. The use of these terms is not intended to limit the structure and / or implantation of the lens. For example, the orientation of the lens within the eye can be changed such that the anterior optic 145 is positioned anteriorly along the optical axis A of lens 100 relative to the anatomical structure 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 anatomical structure of the ophthalmoplement. The membrane as used herein may refer to a wall portion of the lens body that forms part of the sealed fluid chamber of the lens body containing an incompressible optical fluid, and is generally configured to move when force is applied during use of the intraocular lens to achieve adjustable shape changes of the lens body.

[0018] Continuing with the reference to Figure 2B, the solid optical component of lens 100 forms a sealed, fixed-volume fluid chamber 155 containing a fixed volume of liquid optical material. The fluid chamber 155 may be partially defined by internal side walls 1550, which may be vertical, inclined, curved, or a combination thereof. The shape of the side walls 1550 of the chamber 155, and therefore the shapes of the dynamic film 143 and the static front optical portion 144, may vary. The shape selected for the solid component may depend on whether the liquid optical material contained within the lens chamber 155 has the same refractive index as the solid optical component or a different refractive index, which will be discussed in more detail below.

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

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

[0021] Figure 3A is a schematic diagram of one embodiment of the front optic 145, showing the front surface 1430 of the dynamic film 143 and the front surface 1440 of the static front optical portion 144, as well as the rear surface 1435 of the dynamic film 143. The front surfaces 1430 and 1440 are convex and can have the same or different curvatures. For example, the front surfaces can have a spherical, single-radius profile or an aspherical profile. The rear surface 1435 of the dynamic film 143 may be planar. In this embodiment, the surface that controls the differential thickness gradient is the front surface 1430 of the dynamic film 143, which causes a gradual change in thickness from the peripheral region of the lens toward the center.

[0022] Aspherical profiles can be designed using the following aspherical equations.

number

[0023] [Table 1] TIFF0007868060000002.tif36142

[0024] Figure 3B is a schematic diagram of the front optic 145 showing different thickness gradients. The front surfaces 1430 and 1440 are convex and can have the same or different curvatures. The rear surface 1435 of the dynamic film 143 also has a convex curvature and can have a single radius or an aspherical equation. Both the front and rear surfaces control the thickness gradient, which in this embodiment causes a rapid change in thickness from the peripheral region of the lens towards the center.

[0025] Figure 3C is a schematic diagram of the front optic 145 showing a different thickness gradient. The front surfaces 1430 and 1440 are convex and can have the same or different curvatures, and the curvature can be a single radius or an aspherical equation curvature. The rear surface 1435 of the dynamic film 143 has a concave curvature and can have a single radius or an aspherical equation curvature. Both the front and rear surfaces control the thickness gradient in this embodiment, but produce a gradual change in thickness from the peripheral region of the lens toward the center.

[0026] Figure 3D is a schematic diagram of the front optic 145 showing a different thickness gradient. The front surfaces 1430 and 1440 are convex and can have the same or different curvatures, and the curvature can be a single radius or an aspherical equation curvature. The rear surface 1435 of the dynamic film 143 may be convex at the periphery and flat in the center. At the periphery, both the front and rear surfaces control the thickness gradient, while the front 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 film 143 can be maximized at the center. The thickness at the center can be 5 to 30 microns thicker than the thickness of the dynamic film 143 at the periphery near the static front optical portion 144. The center of the dynamic film 143 can be greater than 50 microns and 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, and any range in between these ranges. In this embodiment, the periphery of the dynamic film 143 may have a cross-sectional thickness of about 50 microns to about 70 microns, and the central part of the dynamic film 143 may have a cross-sectional thickness of about 60 microns to about 80 microns.

[0028] The cross-sectional thickness of the static front optical portion 144 can also vary between its outermost peripheral region and a more central region. Figure 2B shows that the cross-sectional thickness of the static front optical portion 144 is substantially uniform between the peripheral region near the boundary with the dynamic film 143 and the central region. The static front optical portion 144 may have a front radius of curvature that results in a peripheral region that is slightly thinner compared to the central region. Figure 3A shows that the cross-sectional thickness of the static front optical portion 144 can vary between the peripheral region near the dynamic film 143 and the central region beyond that caused by the front radius of curvature. The inward-facing sidewall 1550 formed by the static front optical portion 144 may have a cross-sectional thickness that tapers towards the center toward the dynamic film 143. As an example, the outermost peripheral region of the static front optical portion 144 may have a first cross-sectional thickness. This peripheral region of the static front optical portion 144 may have a substantially vertical internal sidewall 1550 that defines the chamber 155. The central region of the static front optical portion 144 may have an internal sidewall 1550 that slopes perpendicularly away from the dynamic film 143. The cross-sectional thickness of the static front optical portion 144 decreases in the center and approaches the cross-sectional thickness of the dynamic film 143.

[0029] The diameter of the dynamic film 143 can vary and may differ depending on the shape of the sidewall 1550 forming the chamber 155. As described above and as shown in Figure 2B, the inner sidewall 1550 formed by the static front optical portion 144 can be substantially perpendicular (rear to front) such that the angle between the sidewall 1550 and the inner surface of the dynamic film 143 is approximately 90 degrees. The diameter of the dynamic film 143 may 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 internal sidewall 1550 formed by the static front optical 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 to 500 microns, and the internal sidewall 1550 formed by the static front optical portion 144 may be inclined or angled in a second, more central region forming a second portion of the chamber 155 having a height of about 100 to 600 microns (see Figure 3A). In this embodiment, the angle between the sidewall 1550 and the inner surface of the dynamic film 143 can be greater than 90 degrees, such as about 130 to about 170 degrees. The inclined inner surface of the static front optical portion 144 may result in the diameter of the dynamic film 143 being smaller than the diameter of the first portion of the chamber 155 where the wall of the static front optical portion 144 is vertical. For example, the diameter of the dynamic membrane can be approximately 1.7 mm to 3.0 mm, compared to approximately 3.5 mm to 5.0 mm for the first part of the chamber 155.

[0030] The static front optical portion 144 can have a thickness of approximately 300 to 700 microns from front to rear at its outermost periphery. In contrast, the dynamic film 143 can be thinner. In some embodiments, the dynamic film 143 can have a thickness of approximately 80 microns or less at its thickest point, or approximately 90 microns or less, or approximately 100 microns or less, or approximately 150 microns or less, or approximately 200 microns or less, and any thickness in between these ranges. In some embodiments, the center of the dynamic film 143 has a greater thickness than the periphery of the dynamic film. For example, the center of the dynamic film 143 can be greater than 60 microns and up to approximately 80 microns, or up to approximately 90 microns, or up to approximately 100 microns, or up to approximately 200 microns, and any location in between these ranges. The periphery of the dynamic film can be thinner than the center, for example, by 10 to approximately 30 microns. In other embodiments, the periphery of the dynamic film 143 has a greater thickness than the center. In yet another embodiment, the central and peripheral regions are thicker than the region of film 143 between them.

[0031] The shapes of the chamber 155, the dynamic film 143, and the static front optical portion 144 can be designed in combination with the refractive index (RI) of the solid component (e.g., silicone elastomer) and the liquid component (e.g., silicone oil) of the lens. The external shape of the dynamic film 143 during shape changes may be aspherical and not have a single radius of curvature (see Figures 3E-3F). Rather, the local radius of curvature changes between the center and the periphery of the film 143. The change in curvature on the surface can form a transition zone 1437 where the curvature changes from convex to concave (see Figure 3F). The concave part of the curve can produce optical aberration, which becomes more severe the higher the refractive index of the liquid component in the chamber. This aberration can be controlled by adjusting the RI of the components, but some aberrations become so severe that they cannot be corrected. Therefore, for film designs that are aspherical and incorporate a transition zone in the curvature during shape changes, it is preferable to use a liquid component with a lower RI than that of the solid component. In cases where a transition zone is incorporated, it is advantageous to limit the width of the transition zone.

[0032] Other film designs are substantially spherical and can have an external shape during shape change with a single radius of curvature between the center and periphery of film 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 solid component, which affects the optical quality (see Figures 3I-1 and 3I-2). Figure 3I-1 is an image of a front film using an optical measuring instrument 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. Optical quality is often characterized as a modulation transfer function (MTF), which can be measured using IOLA-Multifocal Diffractive (Rotlex, Israel). Parallel or substantially parallel lines shown in Figure 3I-1 indicate good optical quality, while distorted images indicate poor optical quality. Figure 3I-2 schematically shows the lens of Figure 3I-1, illustrating the light rays (arrows) passing through film 143 and diverging upon entering the liquid component. The light beam near the central region (solid arrow) where internal curvature is absent is hardly affected upon entry into the liquid component. The light beam with internal curvature (dotted arrow) forms a divergent lens when the oil matching is insufficient, negatively impacting the optical quality. The relative refractive index of the materials affects the optical quality. In contrast, internal curvature between the solid and liquid components of a lens forms no lens or a converging lens without affecting the optical quality if the liquid component is index-matched or over-matched to the RI of the solid component (see Figures 3J-1 and 3J-2). Figure 3J-1 is an image of the front film using an optical measuring instrument to evaluate the optical quality of a lens having solid and liquid components, where the liquid component has an RI that is index-matched to the RI of the solid component. Figure 3J-2 schematically shows the lens of Figure 3J-1, illustrating the light rays (arrows) that pass through film 143, enter the liquid component, and converge. Light rays near the central region where there is no internal curvature and light rays where internal curvature exists do not form a lens when the oil is over-matched, but form a converging lens when the oil is coefficient-matched.

[0033] The intraocular lenses described herein are preferably formed from materials configured for small-incision implantation. The solid optical components of the lens may have elastomer properties, be optically transparent, biocompatible, and be made from a flexible, soft silicone polymer having a sufficiently low Young's modulus to allow the lens body to change its degree of curvature during accommodation in certain situations. It should be understood that some solid optical components may have different Young's moduli than other solid optical components to provide the lens with different functions (e.g., the dynamic membrane 143 bends outward during accommodation compared to the immobile, static anterior optical portion 144 that relieves distortion during accommodation). Suitable materials for the solid optical components of the lens include, but are not limited to, silicones (e.g., alkylsiloxanes, phenylsiloxanes, fluorinated siloxanes, and combinations / copolymers thereof), acrylics (e.g., alkylacrylates, fluoroacrylates, phenylacrylates, and combinations / copolymers thereof), urethanes, elastomers, plastics, and combinations thereof. In some embodiments, the solid optical components of the lens are formed from a silicone elastomer as described herein. The solid optical component may be formed from one or a combination of the materials described herein, in which the liquid optical material described herein is completely encapsulated by the solid optical component. The solid optical component of a lens may include one or more regions configured to be in contact with and / or contain the liquid optical material. The liquid optical material described herein may be specially formulated for the solid optical component to mitigate lens instability and optimize optical quality. 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 PCT / US2021 / 37354, filed June 15, 2021, which is incorporated herein by reference in whole.

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

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

[0036] Referring again to Figure 4A, the front optic 145 can be a flexible optic formed from an optically transparent, low modulus polymer material such as silicone, polyurethane, or flexible acrylic. The front optic 145 may include a static front optical portion 144 surrounding a central dynamic film 143 configured to curve outward, as discussed elsewhere in this specification. The dynamic film 143 can be positioned relative to the lens body 105 such that the optical axis A of the lens extends through the dynamic film 143. The front optic 145 can have a variable thickness. For example, the dynamic film 143 may have a reduced thickness compared to the static front optical portion 144. The thinner cross-sectional thickness of the dynamic film 143 compared to the cross-sectional thickness of the static front optical portion 144 allows the dynamic film 143 to bend relatively easily when a force is applied to its inner surface. For example, if the force applied to the inner surface of the front optic 145 increases during the deformation of the fluid chamber 155, the dynamic film 143 bends outward along the optical axis A of the lens 100, while the static front optical portion 144 maintains its shape. The dynamic film 143 can be configured to cause outward curvature of its outer surface (e.g., the front surface) by the pressure applied to the inner surface of the front optic 145 by the liquid optical material in the fluid chamber 155. The outer static front optical portion 144 of the front optic 145 can have a greater thickness than the inner dynamic film 143 of the optic 145 and can be more resistant to reshaping under such internal pressure applied by the liquid optical material in the fluid chamber 155. The outer static front optical portion 144 of the front optic 145 can provide correction of distance vision even if the inner dynamic film 143 is reshaped for near vision.

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

[0038] The dynamic film 143 may also include multiple materials, for example, a material configured to flex near the center of the dynamic film 143 and other materials configured to reinforce the optic zone and limit strain. Thus, the dynamic film 143 of the front optic 145 can be formed from a material that is relatively more susceptible to outward bending than the material of the outer static front optical portion 144. Various regions of the optic 145 can be injection molded or compression molded to provide a relatively seamless and uninterrupted outer surface. The dynamic film 143 may have different stiffnesses or elasticities that cause it to bend outward more than the static front optical portion 144, but the material of each region can be generally consistent.

[0039] The anterior optic 145 may be configured to have various multifocal capabilities to provide the wearer of the lens 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. As used herein, the term “optic zone” generally refers to the region of the lens body 105 surrounding the optical axis A of the lens and which is optically distinct for vision. As used herein, the term “adjustable zone” generally refers to the region of the lens body 105 that can undergo shape changes for focusing (e.g., dynamic membrane 143). The optic zone is configured to have corrective force, but the entire optic zone does not necessarily have the same corrective force. For example, the dynamic membrane 143 and the static anterior optical portion 144 of the anterior optic may each be located within the optic zone. The dynamic membrane 143 may have corrective force, while the static anterior optical portion 144 may not. Alternatively, for example, the diameter defined by the dynamic film 143 may have optical power, and the static front optical portion 144 may have greater or less power than that of the dynamic film 143. The dynamic film 143 may be equal to or smaller than the overall optic zone, and a multifocal lens can be created. The adjustable zone of the lens body 105 may be equal to or smaller than the overall optic zone.

[0040] The shape-deforming film 140 can extend along the arc length of the equatorial region of the lens body 105. The arc may be long enough, either alone or in combination with other shape-deforming films 140, to cause a reactive shape change in the dynamic film 143 when the shape-deforming film 140 moves inward (or outward). The movement of the shape-deforming film 140 generally inward toward the optical axis A of the lens 100 during adjustment can cause the dynamic film 143 to bend or warp outward without affecting the overall optic zone diameter along any axis.

[0041] The shape-deforming film 140 is movable and can have flexibility that allows it to undergo displacement relative to the lens body 105, the static element 150, and the front optic 145. For example, the shape-deforming film 140 can have greater flexibility than the adjacent region of the lens body 105 so that it can selectively move relative to the lens body 105 and the static front optical portion 144 of the front optic 145. The shape-deforming film 140 can have a stationary position. The stationary position of the shape-deforming film 140 varies. In some embodiments, the stationary position is when the shape-deforming film 140 is positioned approximately perpendicular to a plane parallel to the front optic 145 such that it has a cross-sectional shape oriented vertically, parallel to the optical axis A. The shape and relative arrangement of one or more side deformation films 140 provide the lens with high adjustability with low force and little movement.

[0042] The movement of the shape-deformable film 140 can be of other types, such as compression, collapse, indentation, stretching, deformation, deflection, displacement, hinge, etc., and when a force is applied to the shape-deformable film 140, it moves in a first direction (for example, generally toward the optical axis A of the lens body 105).

[0043] The shape-deforming membrane 140 is adjacent to, coupled to, or integrally molded with each force-transforming arm 115. One or more force-transforming arms 115 are configured to utilize the movement of one or more ciliary structures so as to be bidirectional relative to the lens body 105 to bring about a change in the accommodative shape of the lens body 105. For example, without limiting this disclosure to a particular theory or mode of operation, the ciliary muscle 18 is substantially annular or sphincter. In natural circumstances, when the eye looks at a distant object, the ciliary muscle 18 within the ciliary body relaxes, and the inner diameter of the ciliary muscle 18 increases. The ciliary process pulls on the ciliary zonule 20, which pulls on the lens capsule 22 near its equator. This causes the lens to flatten or lose its convex shape, 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) decreases. The ciliary process releases tension from the ciliary zonule 20, and the natural lens springs back to its natural, more convex shape, allowing the eye to focus at close range. This medial / anterior movement of the ciliary muscle 18 (or one or more ciliary structures) can be utilized by the force conversion arm 115 to cause a change in the shape of the lens body 105.

[0044] In some embodiments, when the force conversion arm 115 is moved inward toward the optical axis A of the lens 100 by ciliary muscle contraction, the force conversion arm 115 abuts against the outer surface of the shape-deforming membrane 140 and applies force to the outer surface. Thus, the contact between the shape-deforming membrane 140 and the force conversion arm 115 can be reversible, such that when the ciliary muscle contracts, the force conversion arm 115 is biased toward the outer surface with which it contacts the membrane 140, biasing the membrane 140 inward. When the ciliary muscle relaxes, the shape-deforming membrane 140 returns to its resting position, and the force conversion arm 115 returns to its resting position. The elastomeric properties of the movable components (i.e., the dynamic membrane and / or shape-deforming membrane) can cause the force conversion arm 115 to return to its resting position. In some embodiments, and as best shown in Figure 4E, the shape-deforming membrane 140 is coupled to or integrated with each force conversion arm 115. As in other embodiments, during ciliary muscle contraction, the force conversion arm 115 and the shape-deforming membrane 140 move together from a stationary position to a position displaced generally inward, causing a change in the shape of the dynamic membrane 143. The displacement of the force conversion arm 115 and the associated shape-deforming membrane 140 applies a compressive force to the fluid chamber, resulting in the deformation of the chamber and causing the dynamic membrane 143 to bulge outward.

[0045] The inward motion of the force conversion arm 115 and the associated shape-deforming 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, and up to about 5 degrees. The compressive force applied to the force conversion arm 115 by the ciliary structure, etc., may result in radially inward motion that is not perfectly orthogonal to the optical axis A, and it should be understood herein that several angular values ​​greater than or less than 90 degrees are considered. The angle between the motion axis of the deformation membrane 140 and the optical axis A may also be substantially non-orthogonal or non-right-angle. 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 vary and may depend on the overall diameter and thickness of the device, internal volume, refractive index of the material, etc. Generally, the lens body has sufficient rigidity and bulk to be handled and manipulated during implantation, while the deformation membranes 140 have 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 having an arc length between about 2 mm and about 8 mm. A single shape deformation membrane 140 may be designed to move between about 10 μm and about 100 μm when a low force is applied, with a force of about 0.1 gram force (gf), in order to achieve a change of at least 1D, or 1.5D, or 2D, or 2.5D, or 3D of the dynamic membrane 143. In some embodiments, the intraocular lens may have two opposing shape-deformable membranes 140, each having an arc length between approximately 3 mm and approximately 5 mm. The shape-deformable membranes 140 are designed to move between approximately 25 μm and approximately 100 μm when an applied force of approximately 0.25 gf to 1.0 gf is applied, thereby achieving a change of at least 1D of the dynamic membrane 143.

[0047] The shape-deformable membrane 140 can move or collapse relative to the rest of the lens body when a certain amount of compressive force is applied. Generally, intraocular lenses are designed so that very small forces (including not only applying compressive force toward the optical axis A, but also releasing the compressive force) can cause micron-scale movements sufficient to produce a sufficient change in power, with reliable optics. The compressive force applied to achieve the outward movement of the dynamic membrane 143 of the lens body 105 to enable accommodation can be as low as about 0.1 gram force (gf). In some embodiments, the applied compressive force may 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., shape-deformable membrane 140) relative to the central portion of the lens body 105 (e.g., dynamic membrane 143) can be as small as about 50 μm. The relative movement of the shape-deformation film 140 of the lens body to the dynamic film 143 in response to the applied compressive force may be between approximately 50 μm and approximately 500 μm, between approximately 50 μm and approximately 100 μm, between approximately 50 μm and approximately 150 μm, or between approximately 100 μm and approximately 150 μm. The range of applied compressive force (e.g., approximately 0.1 gf to approximately 1 gf) that results in these ranges of movement in the shape-deformation film 140 (e.g., 50 μm to 100 μm) can provide the apparatus described herein with an adjustment capability within a dynamic range greater than at least ±1 D, preferably greater than approximately ±3 degrees (D). In some embodiments, the degree is between ±4 D and ±6 D for a movement of approximately 100 to 150 μm. The apparatus described herein may have an adjustable range of at least ±1D for a movement of about 100 μm of the shape-deformable film 140 and at least 0.25 gf of compressive force applied to the shape-deformable film 140 substantially inward toward the optical axis A. In some embodiments, the apparatus may have an adjustable range of at least ±3D for a movement of about 100 μm and at least about 1.0 gf. In some embodiments, the apparatus may have an adjustable range of at least ±3D for a movement of about 50 μm and at least about 0.1 gf.

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

[0049] As described above, and continuing to refer 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 each other along the optical axis A of the lens 100. The static element 150 may be positioned outside the lens body 105 such that a flat surface 151 forms the inner surface of the lens body 105 facing the fluid chamber 155, and a curved surface 152 contacts the fluid of the eyeball. Alternatively, the static element 150 may be positioned inside the lens body 105 such that a flat surface 151 contacts the fluid of the eyeball, and a curved surface 152 forms the inner surface of the lens body 105 facing the fluid chamber 155.

[0050] The static element 150 is optically transparent and can provide support without affecting the optical system of the lens 100. Thus, the static element 150 may have zero power and can form a rear support for the lens body 105. The static element 150 can be made of silicone, urethane, acrylic material, low-elasticity elastomer, or a combination thereof. The static element 150 may be a static optic for correcting an emmetropic state, or may have a power appropriate for aphakia patients (usually ±10D to ±30D). Therefore, the static element 150 may not have 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 may have a power in the range of about -5D to about +5D to correct residual refractive aberrations or other optical aberrations in the optical system of the eye. The static element 150 can be plano-convex, convex-plano, convex-convex, concave-convex, or any other combination. The static element 150 (or the lens positioned behind it) can be a toric lens, a spherical lens, an aspherical lens, a diffractive lens, or any combination of both, for example, to reduce or compensate for aberrations associated with the flexible lens. The relative refractive index of the static element 150 and the fluid surrounding it (whether it be the fluid of the eyeball or the liquid optical material in the fluid chamber 155) determines the degree of the 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, reinforcements may be provided in the peripheral region of the front lens 145 and / or the static element 150. The reinforcement structure may be optically transparent or opaque. The reinforcement structure may be formed from a rigid polymer including, but not limited to, silicone, polyurethane, PMMA, PVDF, PDMS, polyamide, polyimide, polypropylene, polycarbonate, etc., or combinations thereof. Other regions of the lens 100 may also include one or more reinforcements or supports. In some embodiments, one or more supports may be positioned outside the fluid chamber 155 such that the supports surround at least the outer portion of the lens body 105. For example, the external support may be a generally annular element extending to surround the outer circumference of the lens body 105 and may have a central opening into which at least the dynamic membrane 143 of the front optic 145 is aligned, so that the dynamic membrane 143 is deformable outward.

[0052] In some embodiments, the lens 100 includes one or more internal supports positioned within one or more regions of the lens 100, configured to mechanically isolate the optical elements (front and rear) from stresses applied by other parts of the lens, such as a stabilization system 120 and / or a force conversion arm 115, in order to limit optical distortion. Generally, the material and / or structure of the internal supports provides sufficient rigidity to mechanically isolate the optical elements, particularly when the lens 100 is placed under stresses applied 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 the optical elements even during the movement of other lens components (e.g., haptic, force conversion arm, etc.), thereby preventing or mitigating optical distortion. Support is provided to ensure that when the lens is placed under certain forces or stresses, it does not cause shape changes to the optical parts of the device, such as the dynamic membrane 143 or the front optic 143. The strength of the internal support relative to other parts of the lens 100, such as the shape-deformable membrane 140 and the dynamic membrane 143, improves the durability of the lens during insertion, handling, and other operations.

[0053] As will be described in more detail below, the internal supports may be located 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. One or more internal supports may be placed on or embedded within the thickened portion on the inside of the static front optical portion 144 outside the front optic 145. Alternatively, one or more internal supports may be separate components coupled to or located within one or more regions of the lens. One or more internal supports may be coupled to and / or embedded within the static front optical portion 144 of the front optic 145. The internal supports may be made of a material (or a combination of materials) that is harder, thicker, and / or more rigid than the shape-deformable film 140 or dynamic film 143 of the front optic 145 in order to prevent unintended movement of the moving parts of the device. Alternatively, the internal support can be formed from the same material as the shape-deformable film 140 or dynamic film 143 of the front optic 145, thereby achieving the function of mechanical isolation through the shape of the support structure. The support can be formed from rigid polymers including, but not limited to, silicone, polyurethane, PMMA, PVDF, PDMS, polyamide, polyimide, polypropylene, polycarbonate, or combinations thereof. For example, the internal support can be a plurality of silicones or a combination of silicones with rigid or semi-rigid skeletal inserts.

[0054] The internal support can be formed in any of a variety of configurations, sizes, shapes, and / or materials. The internal support may include material embedded within the material of another part of the front optic 145. The cross-sectional views in Figures 4E-4F show an internal support 110e embedded within the outer static optical portion 144. The cross-sectional view of the lens shown in Figure 4G shows the top surface of the front optic 145, including the central dynamic membrane 143, cut off, exposing the fluid chamber 155 and a number of connecting columns 112. These connecting columns 112 may be part of the front optic 145 or may be made from the same material as the front optic 145. These connecting columns 112 may be part of the rearview mirror 150. The connecting columns 112 can be used to couple the front optic 145 to the rear optic. In some embodiments, columns of different materials can support the optical system of the lens. Hereinafter, the columns 112 and the embedded support 110e may be collectively referred to simply as the internal support 110.

[0055] Again with respect to Figures 4E, 4F, and 4G, the embedded internal support 110e may include one or more reinforcing members or other components or materials embedded within the polymer of the front portion of the lens body 105. For example, the embedded support 110e may be a rigid silicone material embedded in a soft silicone material of another solid portion of the lens. The embedded support 110e may be any of the various materials provided herein, including but not limited to silicone, polyurethane, PMMA, PVDF, PDMS, polyamide, polyimide, polypropylene, polycarbonate, or combinations thereof. The embedded internal support 110e may be a relatively planar element lying approximately parallel to the central longitudinal plane of the lens 100. The outer region of each support 110 may be positioned adjacent to the equatorial region of the lens body 105 and extend inward toward the dynamic membrane 143 of the front optic 145. The outer region of the support 110e may be coupled to the equatorial region of the lens body 105, or it may be integrated with the equatorial region of the lens body 105, or the outer region of the support 110e may be separated from the equatorial region. The support 110e may extend along the length of the peripheral region of the static front optical portion 144, but may be separated from the equatorial region near where the deformation film 140 extends along the arc length of the equatorial region (see Figure 4G). This space away from the deformation film 140 provides tolerance so that the deformation film 140 does not prematurely abut or contact the support 110e or the outer static front optical portion 144 during inward adjustment movement.

[0056] The connecting columns 112 can be relatively narrow, separate structures formed of reinforcing material, integrated, joined, and / or otherwise positioned near the peripheral region 154 of the front optic 145. Figure 4G shows the regions of the connecting columns 112 near the position of each deformation membrane 140. The connecting columns 112 can be positioned spaced inward from each deformation membrane 140. Their positioning relative to the deformation membrane and their relatively narrow shape allow for movement of the deformation membrane 140 without the risk of contact or disruption of deformation. Figure 4G shows that each region of the connecting columns 112 has a pair of connecting columns 112 spaced apart from each other, as well as the distance from the static front optical portion 144 away from the deformation membrane 140 having an embedded internal support 110e. The first embedded internal support 110e can extend along the arc length between each of the deformation films 140, and the second embedded internal support 110e can extend along the arc length between the deformation films 140 on the opposite side of the lens body 105. Figure 4G shows that each region of the connecting columns 112 has two connecting columns 112, but there can also be only one connecting column 112 near each deformation film 140, or there can be two or more connecting columns 112 near each deformation film 140. In general, the connecting columns 112 can be narrower than the embedded support 110e. The embedded internal support 110e can extend along a larger arc length than each of the separate connecting columns 112 so that they are generally longer, wider, and flatter than the connecting columns 112. However, the embedded support 110e can also take on a more distinct shape within the material of the static front optical portion 144, thereby they also form narrow and distinct support points rather than elongated support sections.

[0057] The distribution and spacing of the connecting columns 112 relative to the shape-deformable membrane 140 can minimize contact with the movable parts of the lens, whether in the stationary region of the lens body 105 or near the central region of the lens body 105. Furthermore, the shape of the connecting columns 112 can minimize or limit contact between the connecting columns 112 and the shape-deformable membrane 140. For example, the outer region of the connecting columns 112 can be chamfered near the equator to allow inward movement of the shape-deformable membrane 140 while avoiding contact between the membrane 140 and the outer periphery of the support. The chamfer can be a single chamfer with an angle between approximately 10 and 80 degrees. It should be understood that the outer periphery region of one or more supports does not need to include a chamfer. Contact between the shape-deformable membrane 140 and one or more connecting columns 112 can be avoided by means other than incorporating chamfers. For example, one or more connecting columns 112 can be spaced at a distance from the shape-deformable membrane 140 (e.g., along and / or away from the periphery) to avoid contact. The connecting column 112 also extends a certain distance toward the center of the lens body, providing stability and support, but can have dimensions between the outer region and their inner regions, generally stopping before the central dynamic membrane 143 of the front optic 145. In some embodiments, such as those shown in Figure 4G, the connecting column 112 replaces the static front optical portion 144 at a position along the equator of the lens body 105 near the deformation membrane 140. Thus, the static front optical portion 144 extends only around the equator in the portion of the lens body 105 between the positions of the deformation membrane.

[0058] The connecting columns 112 can have different shapes and sizes to provide an overall shape to the fluid chamber 155. In one embodiment, the columns 112 may include separate slender columns of material extending from front to rear through the lens, scattered between the larger connecting columns 112. The narrower columns are located inside the optic zone of the lens, while the larger internal columns are located outside the optic zone, each positioned away from the movable solid component. The larger connecting columns located outside the optic zone can collectively provide an overall shape to the fluid chamber 155 containing the liquid component. The slender columns of material scattered between the larger internal columns can provide support within these larger hallways or channels of the fluid chamber 155 formed by the larger columns.

[0059] As described above, the lens body 105 is collectively formed by the shape-deformable film 140, the front optic 145, and the inner-facing surfaces of the static element 150, and may include a sealed fluid chamber 155 of a fixed volume containing a fixed volume of liquid optical material. Similar to the inner-facing surfaces of the static front optical portion 144 (having an embedded support 110e) and the dynamic film 143 of the front optic 145, the inner-facing surfaces of one or more inner connecting columns 112 also form part of the fluid chamber 155. Therefore, the distribution, size, shape, and number of one or more connecting columns 112 and the static front optical portion 144 affect the overall shape of the fluid chamber 155 (see Figure 4G).

[0060] Regardless of the configuration, the internal support 110 (both the embedded support 110e and the connecting column 112) can restrict lens movement that reduces efficiency in areas of the lens 100 other than where adjustment is desired. The internal support 110 works to concentrate all ciliary body-induced pressure on the central dynamic membrane 143. By mechanically isolating the dynamic area of ​​the lens 100 and structurally reinforcing the non-dynamic area of ​​the lens 100, the internal support 110 concentrates shape changes only on the areas desired for adjustment, namely the lateral deformation membrane 140 via the movement of the force conversion arm 115 and the dynamic membrane 143 from the increased pressure in the fluid-filled chamber 155. The shape and rigidity of the internal support 110 play a role in mechanically preventing deformation of other lens areas under the increased internal pressure of the fluid-filled capsule.

[0061] The internal support 110 can be formed from any of a variety of materials or combinations of materials, which can be opaque or transparent, but is generally more rigid than the moving parts of the lens 100. In some embodiments, each solid component of the lens 100 is formed from the same material, which offers advantages from a manufacturing standpoint. The materials of the various solid components may be the same (e.g., silicone), but the mechanical properties of the various solid components will differ depending on the function the component performs 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 periphery film 140), but both solid components may be made of the same material. A more rigid solid component may be more rigid than a less rigid solid component due to differences in the shape and dimensions of that component. Thus, although the internal support 110 and the films 140, 143 can be formed from the same silicone material, the films 140, 143 have significantly reduced thickness compared to the internal support 110. As a result, the films 140, 143 deform easily when a compressive force is applied, while the internal support 110 does not deform easily. In some embodiments, the internal support 110 may be a silicone elastomer (e.g., silicone PDMS 70-90 shoreA), and the films 140, 143 may be a silicone elastomer (e.g., silicone PDMS 20-50 shoreA). Furthermore, the internal support 110 may include a shape that imparts higher rigidity and hardness compared to the films 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 way, the liquid optical material contained within the chamber 155 does not cause significant outward curvature of either the dynamic film 143 or the deformable film 140 in a stationary 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 so that the dynamic film 143 has a slight outward curvature in a stationary state. The outward curvature of the dynamic film 143 in a stationary state can reduce optical artifacts (disturbances) of the lens. However, regardless of the degree of outward curvature of the dynamic film 143 in a stationary state, the dynamic film 143 can undergo further outward curvature by applying a compressive force to the shape-deformable film 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 deforms along with the shape of the fluid chamber 155. The deformation of the chamber 155 at a certain location (e.g., the inward movement of the shape-deforming film 140 in micron units) causes the incompressible liquid optical material contained within the fixed-volume fluid chamber 155 to be pressed against the inward-facing surface forming the fluid chamber 155. Reactive deformation of the fluid chamber 155 occurs at a second location, producing a sufficient modulatory change. The dynamic film 143 of the front optic 145 is configured to bend outward when a force is applied (e.g., due to relative thickness and / or elasticity) compared to other parts of the front optic 145, such as the static front optical portion 144. Thus, the inward movement of the shape-deforming film 140 causes the liquid optical material to deform along with the chamber 155, pressing against the inward-facing surface of the front optic 145. As a result, the outer surface of the dynamic film 143 is reshaped by curving outward, making the adjustment portion of the optics zone more convex, and increasing the power of the lens 100. As described above, the internal supports 112 and 110e provide sufficient stability to the lens body 105 and apply compressive force to the shape-deforming film 140, causing micrometer motion while minimizing 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 when stationary, both in an unadjusted, stationary state and during adjustment. The liquid optical material remains within the lens body 105 and can contribute to the adjustment shape change of the dynamic membrane 143 by deforming its shape along with the deformation of the fluid chamber 155. It should be understood that this shape change of the dynamic membrane 143 can occur without actual flow of the liquid optical material within the fluid chamber 155, for example, flow from one part of the chamber to another. Rather, a force applied to the shape-deformable membrane 140 deforms the fluid chamber 155 in a first region, which can cause reactive deformation of the fluid chamber 155 in at least a second region. The fluid chamber 155 has a constant volume and is deformable. The liquid optical material contained within the fluid chamber 155 changes shape along with and in accordance with the shape of the fluid chamber 155. As the incompressible liquid optic material within the fluid chamber 155 is pressed against its inner surface, the inward deformation of the shape-deforming membrane 140 in the vicinity of the static zone of the lens body 105 in one or more parts of the fluid chamber 155 can cause a reactive outward deformation of the outward bulge of the dynamic membrane 143 of the anterior optic 145 in another part of the fluid chamber 155. The liquid optic material does not need to flow between the separate chambers of the intraocular lens; rather, the liquid optic material changes shape along with the change in shape of the fluid chamber 155, causing the accommodative portion of the optic zone of the anterior optic 145 to bend outward and increase the power of the intraocular lens 100. As described elsewhere in this specification, very small movements of the force conversion arm 115 (or a single force conversion arm 115 in the case of an asymmetric mechanism) immediately result in small movements of the shape-deforming membrane 140 to change the shape of the dynamic membrane 143, resulting in a sufficient change in power. Whether these very small movements are symmetrical due to at least one pair of opposing force conversion arms 115 or asymmetrical due to a single force conversion arm 115, the outward curvature of the dynamic membrane 143 achieved is spherical and symmetrical.

[0064] The shape-deforming film 140 is sensitive to small forces applied to the lens body 105. This is useful for accommodative changes in response to ciliary muscle movement. However, this can cause changes in power with undesirable optical results if the liquid optical material moves away from the fluid chamber 155 and, for example, to the surrounding solid optical component 153. As discussed elsewhere in this specification, it is preferable that the liquid optical material is chemically heterogeneous enough to prevent miscibility with the solid optical component 153 it comes into contact with. For example, if the liquid optical material is a 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 silicone elastomer are miscible. The oil tends to penetrate the silicone elastomer, causing unintended changes in the lens's optical power. The surface curvature of the lens body decreases (fewer convex and more concave), the lens power decreases, and it becomes unable to provide the patient with sufficient optical power. This also reduces the lens's ability to undergo sufficient shape changes when needed during accommodation. Even slight changes in internal pressure can lead to undesirable changes in the optical power of the lens.

[0065] Again, with respect to Figures 4A-4H, the lens 100 may include one or more force-converting arms 115 configured to move back and forth relative to the lens body 105 to cause the dioptric changes described elsewhere in this specification. The lenses described herein are particularly suited to utilizing the movement of the ciliary body, applied directly to a force-converting arm 115 positioned relative to the ciliary body structure, for the shape change of the lens. The force-converting arm 115 is configured to utilize and convert the force applied by the ciliary body structure for the shape change of the movable part of the lens body 105 as described above. Each force-converting arm 115 may include an outer contact portion 135 and an inner region 137 operably coupled to the outer circumference or equatorial region of the lens body 105 (see Figure 4E). The inner region 137 of each force-converting arm 115 may be integral with, in contact with, or adjacent to the shape-deforming membrane 140 so that the force-converting arm 115 can move relative to the relaxed shape-deforming membrane 140. For example, the force conversion arm 115 can move away from the membrane 140 when stationary, move inward relative to the membrane 140 to bias the membrane 140 inward during adjustment, and move away from the membrane 140 when adjustment is released to relieve the force that deforms the membrane 140 inward. In this way, the inner region 137 of the force conversion arm 115 can reversibly contact the shape-deforming membrane 140 depending on whether an accommodative force is applied by the surrounding ocular tissue. Alternatively, the inner region 137 of each force conversion arm 115 can be physically coupled to the shape-deforming membrane 140 or integrated with the shape-deforming membrane 140 so that the force conversion arm 115 and the membrane 140 move in cooperation with each other.

[0066] In some embodiments, the inner region 137 of the force conversion arm 115 has a cross-sectional thickness along the plane between the front and rear surfaces of the lens body 105 that is narrower than the cross-sectional thickness of the equatorial region of the lens body 105 along the same plane. This allows the inner region 137 of the force conversion arm 115 to displace the deformation film 140 inward without abutting against the equatorial region which 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 need to be narrow. The outer contact portion 135 of the force conversion arm 115 may have a larger cross-sectional thickness than the inner region 137, but it does not need to be. However, it should be understood that the outer contact portion 135 of the force conversion arm 115 may also have the same cross-sectional thickness as the inner region 137. The outer contact portion 135 may also have a rounded or curved contour.

[0067] The force conversion arm 115 protrudes beyond the equator of the lens body 105, which defines 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 Figure 4H). The second outer diameter D2 can 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 can be between approximately 5.0 mm and approximately 9.0 mm, and the second outer diameter D2 can be between approximately 8.5 mm and approximately 13.5 mm. The first outer diameter D1 can be between approximately 6.5 mm, and the second outer diameter D2 can be between approximately 10.2 mm and 11.1 mm.

[0068] The force-transforming arms 115 of the lenses described herein are designed to contact ciliary tissue, which provides a substantially non-circular outer surface. Therefore, the contact area between the lens and the surrounding tissue is much smaller than that of lenses designed, for example, to be fully implanted within a encapsulated sac. Encapsulated lenses generally make 360-degree contact with the sac to support the sac structure and maintain the distance between the anterior and posterior segments of the sac. Each force-transforming arm 115 of the lenses described herein can make contact with the ciliary tissue at an angle of approximately 30 to 120 degrees. For lenses with two force-transforming arms 115, the contact between the lens and the ciliary tissue is between approximately 60 and 240 degrees. In one embodiment, each force-transforming arm 115 of the lens makes contact with the ciliary tissue at approximately 90 degrees, and the contact between the entire lens and the surrounding ciliary tissue is approximately 180 degrees. The outer contact portion 135 of the force conversion arm 115 can provide contact with the surrounding ciliary tissue at angles of approximately 240 degrees, 210 degrees, 180 degrees, 150 degrees, 120 degrees, 90 degrees, and a minimum of approximately 60 degrees. Based on a ciliary process diameter of approximately 10.5 mm, the force conversion arm 115 can have a minimum contact along a 2.5 mm arc and a maximum contact along a 6 mm arc, such that the total contact made by the force conversion arm 115 is approximately one-third of the ciliary process.

[0069] The outer contact portion 135 of the force-transforming arm 115 can be designed to contact the ciliary tissue while minimizing contact with the posterior side of the iris. Increased bulk in this region of the posterior chamber may increase the patient's risk of glaucoma. In one embodiment, the anterior corner of the force-transforming arm 115 can be chamfered or tapered so that the thickness of the arm from anterior to posterior decreases towards the outermost periphery compared to the more central region of the arm, in order to minimize contact between the arm 115 and the iris (see Figure 4D). The force-transforming arm 115 may have an anterior-facing surface 116. The entire anterior-facing surface 116 of the force-transforming arm 115 may remain below or behind the plane P1 of the anterior-facing surface 106 of the lens body 105. The chamfering of the front corner of the force conversion arm 115 may result in the outermost circumference of the arm 115 lying in a plane P3 posterior to the plane P2 of the inner region of the arm 115, as shown in Figure 4D, and both planes P2 and P3 may result in both planes lying posterior to the plane P1 of the front surface 106 of the lens body 105. The arrangement of the lens body 105 and the arm 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 periphery 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 lateral thickness of approximately 0.4 mm to approximately 0.6 mm. The contact area between the lens and the ciliary tissue can have an arc length of approximately 2.5 mm to approximately 6.0 mm or less. For example, compared to in-the-bag style lenses, despite such a small contact area, the lenses described herein can achieve minimal shape changes.

[0070] The contact portion 135 of the force conversion arm 115 can incorporate features that improve connection with one or more ciliary structures without causing damage. Generally, the contact portion 135 avoids piercing or traumatizing 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 traumatizing the tissue itself, while interfering with the ciliary structures. The outer contact portion 135 can also be molded to have one or more recesses, depressions, grooves, teeth, combs, or other surface features to improve contact and / or mating with ocular tissue, such as ciliary processes or nodontiformes. Figure 4D shows that the lower surface of the force conversion arm 115 can have a contour shape or surface feature such as a ridge 179. The arm 115 can have a rearward-facing surface 117. The inner region of the rearward-facing surface 117 near the equator of the lens body 105 may be substantially planar so as to be substantially located within plane P4. The ridge 179 can be positioned near the outer region of the rearward-facing surface 117 of the arm 115, which is farther from the equator of the lens body 105. Within the plane P4, the ridge 179 can project rearward relative to the planar inner region of the rearward-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 resting contact with at least one of the ciliary structures (i.e., the ciliary zonule, ciliary process, ciliary muscle, and / or ciliary body) or readily in contact when the ciliary muscle 18 is contracted, thereby driving changes in the shape of the optical system during adjustment and de-contraction. In a preferred embodiment, the lens 100 is implanted such that the contact portion 135 of the force conversion arm 115 is in stationary or ready contact with the tip of the ciliary body. In another preferred embodiment, the lens 100 is implanted such that the contact portion 135 of the force conversion arm 115 is in stationary or ready contact with the ciliary body. In some embodiments, the lens 100 is made to be generally oversized relative to the ciliary structures. This ensures contact between the force conversion arm 115 and the ciliary structures during adjustment. In some embodiments, the lens may be enlarged by at least approximately 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 it is not necessary to enlarge the lens size, and in some situations, it may be possible to avoid enlarging the lens size. 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-shifting arm 115 described herein may have a fixed length. A fixed-length force-shifting arm 115 may have a size selected to be appropriate for each patient based on preoperative measurements. Alternatively, the length of the force-shifting arm 115 may be adjustable. The length of the force-shifting arm 115 can be adjusted at any time before, during, or after insertion into the eyeball. Along with the adjustment of the length of the force-shifting arm 115, the position of the force-shifting arm 115 relative to one or more ciliary structures may also change. In some embodiments, the force-shifting arm 115 may extend substantially parallel to the plane of the lens 100, or it may be angled relative to the plane of the lens 100.

[0073] As the ciliary muscle contracts toward the optical axis A of the lens 100, a force is applied to the contact portion 135 of the force conversion arm 115 as one or more ciliary structures move inward / forward. The force conversion arm 115 has sufficient rigidity to the deformation membrane 140 and transmits the force applied by one or more movable 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 may be a rigid polymer such as silicone, polyurethane, PMMA, PVDF, PDMS, polyamide, polyimide, polypropylene, polycarbonate, or a combination thereof. In some embodiments, the force conversion arm 115 may be an element reinforced with a rigid material. For example, the force conversion arm 115 may have an inner rigid element such as silicone elastomer, polyurethane, or flexible acrylic material, covered with a soft material such as silicone elastomer, polyurethane, PMMA, PVDF, PDMS, polyamide, polyimide, polypropylene, or polycarbonate, which is hydrophobic or hydrophilic. In silicone, polyurethane, PMMA, PVDF, PDMS, polyamide, polyimide, polypropylene, and polycarbonate, the force conversion arm 115 may include an internal rigid element extending between the outer contact portion 135 and the inner contact portion 137. In silicone, polyurethane, PMMA, PVDF, PDMS, polyamide, polyimide, polypropylene, and polycarbonate, the internal rigid element extends only along the partial length of the force conversion arm 115 between the outer portion 135 and the inner portion 137. For example, the internal rigid element does not need to extend explicitly to the outer contact portion 135 where the force conversion arm 115 contacts the ciliary structure in order to provide a softer, non-traumatic surface so as not to damage the ciliary structure. The internal rigid element also does not need to extend explicitly to the inner contact portion 137 so that the internal rigid element of the force conversion arm 115 remains outside the lens body 105 when the shape-deformable membrane 140 is moved inward by the force conversion arm 115. Generally, the force conversion arm 115 is formed of a material and / or size such that it maintains its shape when force is applied by the ciliary structure and does not collapse or deform when transmitting that force to move the shape-deformable membrane 140.As described above, the movement of the shape-deforming film 140 causes a change in shape within the fluid chamber 155, altering the shape of the liquid optical material contained within it. When the liquid optical material is pressed against the inner surface of the lens body 105, an outward curvature occurs in the dynamic film 143 of the front optic 145. This outward curvature makes the shape of the lens body 105 more spherical or convex, increasing the lens power suitable for near vision focusing.

[0074] The number of force-converting arms 115 and shape-deforming membranes 140 can vary. The lens 100 may include two force-converting arms 115 positioned on opposite sides of the device, lying adjacent to two shape-deforming membranes 140, as shown in Figure 4E. Alternatively, the lens 100 may include a single force-converting arm 115 that is movable in a manner sufficient to change the shape of the dynamic membrane 143 of the front optic 145 to achieve a desired power change. The lens 100 may also include two or more arms, such as three, four, or more force-converting arms 115 arranged around the lens body 105. The force-converting arms 115 can be arranged symmetrically or asymmetrically around the lens 100. It should be understood that the number of force-converting arms 115 does not need to match the number of shape-deforming membranes 140. For example, the lens 100 may include a single shape-deforming membrane 140 extending along the arc length of the equatorial region of the lens body 105, and a plurality of force conversion arms 115 configured to contact or connect 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 can be configured to maintain the alignment of the optical system of the device and to resist movement of the device as the device is implanted and undergoes shape changes. Unlike the force conversion arm 115, the stabilization system 120 does not cause adjustment of the lens 100. And since the force conversion arm 115 is independent of the stabilization system 120 and does not need to fix, center, stabilize, and / or hold the lens 100 in position within the eyeball, the lens 100 described herein can 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, as part of the lens body 105, or to an external support if present, by bonding, bonding, or molding. The stabilization system 120 can be coupled to a rear region of the device 100 to provide stabilization and engagement with a part of the encapsulation bag, such as the anterior capsule.

[0077] The stabilization system 120 can vary. The stabilization system 120 includes one or more of the following: a stabilizing haptic, a static haptic, a ring-shaped element, a flange element or wing, or other stabilizing features. The stabilization system 120 may include one or more wings 172 extending outward from a region of the lens, such as the rear end (see, for example, Figure 4C). The front surface of the ring-shaped structure 171 may be coupled to the peripheral connection 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, as specified herein, any of the various coupling arrangements between the stabilization system 120 and the lens body 105 are considered. The ring-shaped structure 171 and the wings 172 may be coupled to other parts of the lens body 105, or integrated with other parts of the lens body 105. Generally, the coupling of the stabilization system 120 to the lens body 105 is such that the wings 172 are positioned rearward 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 Figure 4A, the stabilization system 120 may include a pair of wings 172 extending outward from the periphery of the lens body 105 between the positions of the force conversion arm 115. The wings 172 may have an outer height, but are positioned at a 90-degree angle 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-shaped structure 171 are not transmitted to the lens 100 by the stabilization system 120 in a manner that causes deformation of the fluid chamber 155 or a change in the shape of the dynamic membrane 143. The wing 172 can be positioned rearward relative to the lens body 105 and the force conversion arm 115. The front surface of the wing 172 can also be coplanar with the force conversion arm 115. The further forward the wing 172 is positioned, the greater the rearward push it can exert on the lens body 105.In one embodiment, the wing 172 can bias the lens body 105 rearward while remaining below the plane of the force conversion arm 115. Figure 4D shows a 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 behind both the lens body 105 and the force conversion arm 115. The outer region of the wing 172 that protrudes forward 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 embodiments, the outer region of the forward-projecting wing 172 can be located above, inside, or below the plane P4 of the front-facing surface 117 of the force conversion arm 115. The plane P5 of the projection 179 of the arm 115 can extend rearward relative to the outer height of the wing 172, as shown in Figure 4D.

[0078] The wing 172 can extend beyond the outer diameter of the ring-shaped structure 171 in at least two regions along the outer circumference of the lens body 105. The at least two regions in which the wing 172 extends beyond the outer diameter D1 of the lens body 105 can be oriented relative to the lens body 105 such that the wing 172 provides stabilizing support to the force conversion arm 115. For example, if the lens 100 includes a pair of opposing force conversion arms 115, the wing 172 can be positioned relative to the lens body 105 such that it extends outward from the lens body 105 between the positions of the opposing force conversion arms 115 and defines an outer diameter D3 that is greater than the outer diameter D1 defined by the lens body and smaller than the outer diameter D2 defined by the force conversion arm 115 (see, for example, Figure 4H). It should be understood that the wing 172 may have any of a variety of shapes, including oval, elliptical, cylindrical, and freeform. The wing 172 may also be annular, and its outer diameter D3 may be configured to extend outward beyond the outer diameter D1 of the lens body 105 along a 360° radius. Alternatively, the wing 172 may have two or more locations that extend beyond the outer diameter of the lens body 105, such as three, four, five, or more locations. The wing 172 can provide 360-degree support and stabilization to the lens 100. The outer diameter D1 defined by the lens body may be, for example, between approximately 5.0 mm and approximately 9.0 mm, preferably between approximately 6.5 mm, to fit snugly within the opening of the encapsulation. The outer diameter D2 defined by the force conversion arm 115 may be, for example, between approximately 8.5 mm and approximately 13.5 mm, or between approximately 10.2 mm and approximately 11.1 mm, to extend outward from the encapsulation bag to engage with the ciliary body and utilize its movement. The outer diameter D3 defined by the wing 172 can be sized to be received within the encapsulation bag so as to extend beyond the edge of the encapsulation, for example, between about 6.0 mm and about 10.0 mm, preferably between about 7.5 mm. In this embodiment, the first outer diameter D1 may be about 6.5 mm, the second outer diameter D2 may be between about 10.2 mm and 11.1 mm, and the third outer diameter D3 may be about 7.5 mm.

[0079] As described 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 edges of the wings 172 can project forward so as to form a channel or groove 174 near the inner region 178 of the wings 172 (see Figure 4F). When the lens 100 is placed in the eyeball, the outer protrusions of the wings 172 can engage with the inner surface facing the rear side of the encapsulation (i.e., the front segment of the encapsulation) to help bias the lens 100 rearward relative to the encapsulation. Furthermore, the edge of the encapsulation can be received and held in the groove 174. In some embodiments, the edge of the encapsulation can be trapped 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 even narrower than the outer diameter D1 defined by the lens body 105 (see Figure 4H). The presence of groove 174 and a small outer diameter D4 means that the opening of the capsule can be minimized. The large outer diameter D1 of the lens body 105 can remain in front of the opening inside the capsule, so the capsule membrane only needs to surround the small outer diameter D4 defined by groove 174. The outer diameter D3 defined by wing 172 can be larger than the size of the capsule opening, preventing wing 172 from sliding down in front of the capsule opening once the intraocular lens is in place.

[0080] As described elsewhere in this specification, the force-transforming arm 115 is configured to extend outward from the encapsulation 22, forming a larger outer diameter D2 that engages with the ciliary 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 encapsulation mechanism or encapsulation sac 22. A wing 172 extending outward from the posterior end region of the lens body 105 can define an outer diameter D3 that remains inside the encapsulation sac 22 at the posterior side of the encapsulation, while a force-transforming arm 115 extending roughly from the equatorial or anterior end region of the lens body 105 defines a larger outer diameter D2 that extends outward from the encapsulation sac 22 and engages with the inner diameter of the ciliary structure. The wing 172 can be positioned to engage with the surface facing the posterior side of the edge of the encapsulation sac 22 formed by the anterior capsule in order to improve the fixation of the lens 100 in the eye. The edge of the casing 22 formed by the casing can be received in a groove 174 formed between the rear surface of the lens element 105 and the front surface of the wing 172. The groove 174 allows the edge of the casing 22 to fit snugly into a smaller outer diameter D4 and to be captured by the outer diameter D1 of the lens body 105, which can protrude to the front of the opening of the casing 22. In this way, the relative diameters of the lens body 105 and the groove 174 help to fix the position of the lens snugly in place with the casing.

[0081] The wing 172 may have an interruption to provide flexibility during handling and to allow the surgeon access to the portion of the lens 100 and encapsulation 22 posterior to the wing 172. This is preferable when the surgeon needs to perform procedures such as cleaning the encapsulation, removing viscoelastic material, repositioning the lens, or other procedures that involve manipulating the environment posterior to the lens using instruments. In some embodiments, the interruption may include one or more openings extending through a region of the wing 172 (not shown). The interruption may also include one or more indentations, grooves, or other features near the outer circumference of the wing 172. The interruption may allow for easy insertion into the eye and may allow for the natural drainage of fluid and / or withdrawal of viscoelastic material from inside the encapsulation 22 using a cannula or other instrument known in the art.

[0082] Again with respect to Figure 4C, the annular stabilization structure 171 positioned on the rear side of the lens 100 may include a central opening 173 and a pair of wings 172 projecting outward from the annular stabilization structure 171. In some embodiments, the lens 100 can incorporate two force-transforming arms 115 and two wings 172. The wings 172 can be rotated 90 degrees on the circumference of the lens 100 relative to the arms 115 so that they are positioned between the two force-transforming arms 115. This arrangement prevents the outer height of the wings 172 from obstructing the movement of the force-transforming arms 115. Figure 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-transforming arms 115. The inner region 178 of the wings 172 can be located in a plane that is behind the planes P4, P5 of the surface 117 facing the rear side of the arms 115 (see Figure 4D). The wings 172 can be curved forward toward their outer circumference. The outer height plane of the wing 172 can be located behind the planes P4, P5 of the surface 117 facing the rear side of the arm 115, or, as shown in Figure 4D, it can extend above (or forward) the planes P4, P5 of the surface 117 facing the rear side of the arm 115 and below (or backward) the planes P2, P3 of the surface 116 facing the front side of the arm 115.

[0083] The stabilization structure 171 can be sized and shaped to engage with a corresponding surface of the lens body 105, for example, the surface facing the rear of the rear element 150. It should be understood that the stabilization structure 171 can be molded as an integral part of the lens body 105 and does not need to be a separate part. Therefore, when it is described that the surfaces of the components are engaged or bonded to each other, it should be understood that this may include being molded together as a single integral part.

[0084] The shape of the stabilization structure 171 relative to the lens body 105 can improve the fixation of the lens 100 within the encapsulation pouch by capturing the edge of the encapsulation. The inner region 178 of the wing 172 can be distanced 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 Figure 4B). The lens stabilization system 120 described herein is configured to be inserted into the encapsulation pouch of the eyeball, but the lens adjustment components (e.g., force conversion arm 115 and dynamic membrane 143) can extend outside the encapsulation pouch. When the wing 172 is implanted in the encapsulation pouch such that the outer height of the wing 172 engages with the front portion of the encapsulation pouch, the edge of the encapsulation can be received and held within the groove 174. The shape of the stabilization structure 171 relative to the lens body 105 can also allow for fluid flow through the lens 100. For example, the connection between the stabilizing structure 171 and the lens body 105 can be discontinuous so that the outer height of the wing 172 engages with the surface facing the rear side of the front segment of the bag, allowing fluid trapped on the rear side of the lens 100 to escape from the bag, even if the encapsulation fits snugly within a smaller outer diameter D4 defined by the outer circumference (outer diameter D1) and / or groove 174 of the lens body 105. Near the groove 174, the lens body 105 can further incorporate one or more openings, slots, or cutouts 177 extending 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 notch 177 in the sidewall of the lens body 105 can be located above the inner region 178 of the second wing 172 (see Figure 4B). The cutout 177 forms a fluid channel (for example, for draining fluids such as viscoelastic fluids within the encapsulation bag) from the rear side of the lens 100 (e.g., located inside the encapsulation bag) through the cutout 177 between the stabilizing structure 171 and the rear element 150, and from the front side of the lens 100 (e.g., located inside the anterior chamber) (see arrow A in Figure 4F). Thus, the lens 100 is prevented from being completely sealed with the encapsulation bag, even if the bag fits snugly into the encapsulation bag. The size of the cutout 177 varies.In some embodiments, the width of the cutout 177 approaches the width of the inner region of the wing 172. The cutout 177 does not obstruct the fluid flow through the lens 100 without affecting the stability of the lens 100 during accommodative motion. The wing 172 may further incorporate one or more interruptions or openings as described above.

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

[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, polypropylenes, polycarbonates, or flexible acrylic materials, or any combination thereof. The stabilization system may have a soft body reinforced with a more rigid structure to provide stabilization while maintaining flexibility for insertion and manipulation.

[0087] One or more parts of the stabilization system 120 described herein may incorporate biting elements to improve fixation within the eyeball. In some embodiments, the stabilization system 120 includes haptics, and the biting elements may be positioned near their distal ends to improve the fixation of the haptics within the eyeball. The stabilizing haptics can 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, planar, offset, etc. Haptics considered herein may include haptics designed by Rayner (Rayner Intraocular Lenses Ltd, East Sussex, UK), haptics designed by NuLens (NuLens Ltd., Israel), lens designs by Staar (Staar Surgical, Monrovia, CA), etc. In some embodiments, the stabilization system 120 may be formed from a biocompatible polymer such as silicone, polyurethane, PMMA, PVDF, PDMS, polyamide, polyimide, polypropylene, polycarbonate, PEEK, or a combination of such materials, whether or not it includes one or more haptics or 360-degree wings. The stabilization system 120 may be formed from a foldable material or may be configured to be foldable. In some embodiments, the stabilization system 120 may be formed from a shape memory material.

[0088] The lenses described herein have improved internal and / or external mechanical stability, resulting in more efficient shape changes. The shape changes are more efficient because they occur only in the desired locations (i.e., the shape-changing film 140 and the dynamic film 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, for example, to the mechanical isolation of the moving parts by one or more supports providing sufficient rigidity to the lens 100, thereby enabling effective and efficient shape changes without causing unintentional bulging or distortion in other parts of the device. The inward-facing regions of the lens 100 described herein can have reduced angles, rounded edges, and fewer dead zones, improving the efficiency of the shape change achieved. These embodiments, along with a controlled, continuous thickness gradient of the dynamic film from the periphery to the center, provide the desired predictable optical surface deflection for near vision.

[0089] The various components and features of the lenses described herein can be incorporated into any of the various combinations. Therefore, descriptions of specific features shown with respect to specific drawings are not intended to limit the scope in that such features may be incorporated into other embodiments of the lenses described herein. For example, the lenses described herein may include a stabilization system incorporating one or more features of the stabilization system described herein. Furthermore, a lens having features of a stabilization system can be combined with any of the various features described, for example, with respect to the force conversion arm 115 or the shape deformation membrane 140.

[0090] Suitable materials or combinations of materials for the preparation of various solid optical components of the apparatus disclosed herein are provided throughout. It should be understood that other suitable materials are also possible. U.S. Patent Publications 2009 / 0234449, 2009 / 0292355, and 2012 / 0253459, each incorporated herein in whole by reference, provide further examples of other materials suitable for forming specific components of the apparatus described herein. One or more solid optical components of the lens body 105 can be integrated 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 front optical portion 144 of the front optic 145. Similarly, the shape-deformable film 140 can be integrated with one another, having 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 by techniques known in the art. Thus, one or more solid optical components of the lens body 105 can be formed of the same material or different materials. One or more of the support 110, the static front optical portion 144, the dynamic film 145, and the shape-deformable film 140 can be formed from flexible inelastic films such as silicone, urethane, flexible acrylic, or polyethylene, as well as optically transparent low-elasticity elastomers such as halogenated elastomers such as fluorosilicone elastomers. 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-deformable film 140, the static element 150, the support 110, the static front optical portion 144, and the inner-facing surfaces of the dynamic film 143 of the front optic 145) are formed from 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 from a fluorosilicone elastomer.In some embodiments, the liquid optical material contained within the fluid chamber 155 is an aromatic or phenyl-substituted oil, such as phenyl silicone oil, and the solid optical component forming the fluid chamber 155 is 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 may be a rigid polymer formed from silicone, polyurethane, PMMA, PVDF, PDMS, polyamide, polyimide, polypropylene, polycarbonate, or a combination thereof. In some embodiments, the force conversion arm 115 may be a PMMA-reinforced element. In some embodiments, the lens is formed entirely from silicone material, including the rear static element 150 and the force conversion arm 115. The stabilization system 120 may be formed from a more rigid silicone, or from polyimide, or incorporate polyimide. For example, the stabilization haptics and wings 172 may be polyimide.

[0092] The lenses described herein can provide focusing force over a full range of accommodation from far to near, and can adjust and deaccommodate by mechanically and functionally interacting with ocular tissues normally used by natural lenses, such as the ciliary body, ciliary process, and zonules. The devices described herein may include an accommodative mechanism comprising one or more force-converting arms configured to be positioned within the eye to utilize the movement of one or more ciliary structures and convert that movement into functional force to drive changes in the shape of the lens body for adjustment and deaccommodation, independently of the movement of the encapsulating sac. The lenses described herein can achieve optical power changes of up to approximately 5D or 6D in the range of 1D to 3D. The forces generated by these tissues are functionally converted into the devices described herein that cause power changes for more effective adjustment. The lenses described herein may further include a stabilization system separate from the accommodative mechanism, for example, configured to be positioned within the encapsulating sac. The devices described herein avoid the 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 more ciliary structures, including but not limited to the ciliary muscle, ciliary body, ciliary process, and ciliary zonule. For brevity, the term “ciliary structure” may be used herein to refer to any one or more ciliary structures whose movement can be utilized by a force conversion arm to achieve lens adjustment.

[0093] The devices described herein can be implanted intraocularly in place of a diseased natural lens. These devices can be implanted as an adjunct to a natural lens (in patients with phakicosis) or an intraocular lens previously implanted in the patient's encapsulated sac (in patients with pseudophakicosis). 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, which are incorporated herein by reference in their 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 thicker and typically have powers ranging from ±10D to ±25D. Thick, high-power lenses are generally not accommodative. In contrast, auxiliary lenses do not need to provide significant optical power to the system. Auxiliary lenses are relatively thinner than primary lenses and can undergo more adjustments. Reshaping and moving thin lenses is generally easier to achieve compared to thicker primary lenses. The lenses described herein can be used independently and do not need to be used in combination with natural or implant lenses as piggyback lenses. One or more components of the lenses described herein can be configured to be positioned within the groove 16, relative to the ciliary process, within the encapsulation sac 22, or a combination thereof.

[0094] The devices and systems described herein may incorporate any of the various features. Elements or features of one embodiment of the devices and systems described herein, like elements or features of another embodiment of the devices and systems described herein, may be incorporated, either by substitution or in combination, with the 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 brevity, various combinations are considered herein, but explicit descriptions of each of these combinations may be omitted. Various devices can be implanted, positioned, and adjusted, etc., according to various different methods and using various different devices and systems. Various devices can be adjusted before, during, and after implantation. Several representative descriptions of how various devices may be implanted and positioned are provided, but for the sake of brevity, explicit descriptions of each method for each implantation or system may be omitted.

[0095] In some embodiments, the details will be described with reference to the figures. However, certain embodiments may be carried out without one or more of these specific details, or in combination with other known methods and configurations. In this specification, numerous specific details, such as specific configurations, dimensions, and processes, are described in order to provide a complete understanding of the embodiments. In other examples, well-known processes and manufacturing techniques are not described in particular detail in order to avoid unnecessarily obscuring the explanation. Throughout this specification, references to “one embodiment,” “one aspect,” “one implementation,” “one side,” etc., mean that the specific features, structures, configurations, or characteristics described are included in at least one embodiment, aspect, or configuration. Therefore, the appearance of the phrases “one embodiment,” “one aspect,” “one implementation,” “one side,” etc., as they appear in various places throughout this specification, do not necessarily refer to the same embodiment, aspect, or implementation. Furthermore, specific features, structures, configurations, or characteristics may be combined in any preferred manner in one or more implementations.

[0096] The use of relative terms throughout this specification may indicate, but is not intended to limit, relative position, direction, or orientation. 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 “front,” “rear,” “front part,” and “rear part,” is used to establish a relative reference frame and is not intended to limit the use or orientation of the devices described herein in various embodiments.

[0097] The term "approximately" means a range of values ​​including the specified value that would be reasonably considered similar to the specified value by those skilled in the art. In embodiments, "approximately" means within the range of standard deviations using generally acceptable measurements in the art. In embodiments, "approximately" means a range of ±10% of the specified value. In embodiments, "approximately" includes the specified value.

[0098] While this specification contains many specific details, these should not be interpreted as limitations on the claimed or potentially claimed scope, but rather as descriptions of features specific to particular embodiments. Certain features described herein in the context of separate embodiments may also be implemented in combination in a single embodiment. Conversely, various features described in the context of a single embodiment may also be implemented separately or in any suitable subcombination in multiple embodiments. Furthermore, features are described above as acting in particular combinations, and may even be initially claimed as such; however, one or more features from a claimed combination may, in some cases, be removed from the combination, and the claimed combination may be directed towards subcombinations or variations of subcombinations. Similarly, while operations are depicted in the drawings in a particular order, this should not be understood as requiring that such operations be performed in a specific order shown, or sequentially, or that all illustrated operations be performed in order to achieve a desired result. Only a small number of examples, embodiments, aspects, and forms are disclosed. Variations, modifications, and enhancements to the described examples and embodiments, as well as to other embodiments, can be made based on the disclosed content.

[0099] In the above description and 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 enumerated elements or features individually, or any of the enumerated elements or features in combination with any of the other enumerated elements or features, unless implicitly or explicitly contradicted by the context in which they are 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 intended to mean “A alone, B alone, or A and B together,” respectively. A similar interpretation is intended for lists containing three or more items. For example, the expressions “at least one of A, B, and C,” “one or more of A, B, and C,” and “A, B, and / or C” are 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,” respectively.

[0100] The use of the term “based on” in the foregoing and in the claims is intended to mean “based on at least part of,” in which case features or elements not cited are also permitted.

Claims

1. An adjustable intraocular lens comprising an anterior optic located within the optic zone of the adjustable intraocular lens, and an incompressible optical fluid, The front optic is, For adjustment functions including a dynamic membrane having a difference in thickness gradient between the rear and front surfaces of the dynamic membrane, it includes a central dynamic zone configured to undergo a shape change, Dynamic membranes are The dynamic membrane has a first thickness between the rear surface and the front surface in the central part, The peripheral edge of the dynamic membrane surrounding the central part has a second thickness between the rear surface and the front surface. The first thickness is greater than the second thickness. The first thickness is 5 to 30 microns thicker than the second thickness, and the dynamic film is less than 200 microns at its thickest point. The front optic is also, It includes a peripheral static zone having a static front optical portion configured to resist any shape change, The incompressible optical fluid is contained within a fluid chamber partially defined by the rear surface of the dynamic membrane and the static front optical portion, and by compressing the fluid chamber in a first region, a change in the shape of the central dynamic zone occurs for adjustment. Adjustable intraocular lens.

2. The curvature of the front surface of the dynamic film is convex, and it curves forward along the optical axis of the lens, and The curvature of the rear surface of the dynamic film is concave, curving forward along the optical axis of the lens, or The curvature of the rear surface of the dynamic film is convex, curving towards the rear along the optical axis of the lens, or The curvature of the rear surface of the dynamic membrane is flat. The adjustable intraocular lens according to claim 1.

3. The curvature of the posterior surface of the dynamic membrane is either a single radius or aspherical. The adjustable intraocular lens according to claim 2.

4. The curvature of the front surface of a dynamic membrane is given by a single radius or an aspherical equation. The adjustable intraocular lens according to claim 2.

5. The static front optical portion has a front surface having the same or different curvature as the front surface of the dynamic film. The adjustable intraocular lens according to claim 4.

6. The curvature of the rear surface of the dynamic film is convex, curving towards the rear along the optical axis of the lens. The curvature of the front surface has a larger front radius of curvature than the front radius of curvature of the static front optical portion of the peripheral static zone. The adjustable intraocular lens according to claim 1.

7. The first thickness in the central part of the dynamic film is greater than 50 microns. The adjustable intraocular lens according to claim 1.

8. The dynamic film is 80 microns or less, or 90 microns or less, or 100 microns or less, or 150 microns or less at its thickest point. The adjustable intraocular lens according to claim 1.

9. The first thickness is 60 to 80 microns, and the second thickness is 50 to 70 microns. The adjustable intraocular lens according to claim 1.

10. The diameter of the dynamic membrane is approximately 2.0 mm to approximately 4.0 mm. The adjustable intraocular lens according to claim 1.

11. The inner sidewall formed by the static front optical portion is substantially perpendicular from the rear to the front, and the angle formed between the inner sidewall and the inner surface of the dynamic film is about 90 degrees. The adjustable intraocular lens according to claim 1.

12. The cross-sectional thickness of the static front optical portion is greater than the maximum cross-sectional thickness of the dynamic film. The adjustable intraocular lens according to claim 1.

13. The cross-sectional thickness of the static front optical portion is approximately 300 microns to 700 microns, and the maximum cross-sectional thickness of the dynamic film is approximately 80 microns or less, or approximately 90 microns or less, or approximately 100 microns or less, or approximately 150 microns or less. The adjustable intraocular lens according to claim 12.

14. A lens body comprising a front optic and an incompressible optical fluid contained within a fluid chamber, It further includes at least one force conversion arm, The movement of at least one force conversion arm deforms the fluid chamber and changes the shape of the central dynamic zone of the front optic. The adjustable intraocular lens according to claim 1.

15. At least one force conversion arm includes an inner region operably connected to the equatorial region of the lens body and an outer region opposite to the inner region, The outer region includes a chamfered front corner, and the thickness in the outer region from front to rear of at least one force-transforming arm is less than the thickness in the more central region from front to rear of the arm. The adjustable intraocular lens according to claim 14.

16. A stabilization system further comprising one or more wings extending outward from a region of the lens body and positioned behind the lens body and with respect to at least one force conversion arm with respect to the optical axis of the lens, The lens body includes one or more openings, slots, or cutouts that extend through the side walls of the lens body and are located above the inner region of one or more wings, creating channels for fluid drainage from the rear side of the lens. The adjustable intraocular lens according to claim 14.

17. One or both of the curvature of the front surface and the curvature of the rear surface control the differential thickness gradient across the dynamic film from the periphery to the center, providing predictable deflection when the central dynamic zone is deformed. The adjustable intraocular lens according to claim 1.

18. Before the shape change, when the front optic is in an unadjustable state, both the front and rear surfaces 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 adjustable intraocular lens according to claim 1.

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