Adjustable intraocular lens device for treating eyes and system including the same

Abstract

An adjustable intraocular lens device for treating an eye and a system including the device, the device having: a lens body, an internal support, a stabilization system, and a force conversion arm. The lens body includes an adjustable membrane, an annular element, a stationary element, and a fixed volume of optical fluid filling a sealed cavity of the lens body. The annular element coupled to the periphery of the adjustable membrane has a shape-deformable membrane configured to undergo displacement relative to the periphery area. The sealed cavity is formed by the adjustable membrane, the shape-deformable membrane, and the inner surface of the stationary element. The force conversion arm has a first end and a free end, the first end is operatively coupled to the shape-deformable membrane, and the free end can be used and configured to engage the ciliary structure of the eye. The force conversion arm is movable relative to the lens body to cause inward movement of the shape-deformable membrane. Related methods, devices, and systems are provided.

Description

[0001] This application is a divisional application of the PCT international invention patent application with application number 201780078620.9, application date October 27, 2017, and invention name “Adjustable artificial lens and implantation method”. Technical Field

[0002] The present disclosure relates generally to the field of ophthalmology and, more particularly, to ophthalmic devices including intraocular lenses (IOLs), such as accommodating intraocular lenses. Background Art

[0003] A healthy young eye can focus on objects at a distance or near as needed. The ability of the eye to change back and forth from near vision to distance vision is called accommodation. Accommodation occurs when the ciliary muscles contract, thereby releasing the static zonular tension on the equatorial region of the capsular bag. The release of zonular tension allows the inherent elasticity of the lens to change to a more spherical or spherical shape with increased surface curvature of both the anterior and posterior lens surfaces.

[0004] The human eye lens may be afflicted with one or more disorders that degrade its function in the visual system. A common lens disorder is a cataract, which is an opacification of the normally transparent natural lens matrix. The opacification may be caused by the aging process, but may also be caused by genetics or diabetes. In cataract surgery, the patient's opaque lens is replaced with a transparent lens implant, or IOL.

[0005] In conventional extracapsular cataract surgery, the lens stroma is removed, leaving the thin walls of the anterior and posterior capsules intact along with the zonular ligamentous attachments to the ciliary body and ciliary muscles. The lens nucleus is removed by phacoemulsification with a curvilinear capsulorhexis, ie, the anterior portion of the capsular bag is removed.

[0006] After a recovery period of days to weeks, the capsular bag effectively shrinks and wraps around the IOL due to collapse and subsequent fibrosis of the walls of the capsular bag. Cataract surgery as practiced today causes irreparable loss of most of the natural structures of the eye that provide accommodation. The lens matrix is ​​completely lost, and the capsulotomy reduces the integrity of the capsular bag. The "shrink wrap" of the capsular bag around the IOL may damage the zonules complex, after which the ciliary muscles may atrophy. Thus, conventional IOLs (even those that claim to accommodate) may not provide sufficient axial lens space displacement or lens shape change along the optical axis to provide a sufficient amount of accommodation for near vision.

[0007] In addition to IOL placement after cataract surgery, it is known that an artificial "piggyback" lens can be used to correct the refractive error of the healthy lens. In addition, this "piggyback" approach can benefit patients who have previously undergone cataract surgery, leaving the artificial lens in place, but requiring additional refractive correction. These "piggyback" IOLs can be placed in front of a previously implanted IOL or natural lens to improve the refractive outcome of cataract surgery in the case of pseudophakia, or to change the refractive state of the eye in the case of phakia, usually to correct high myopia. Typically, these lenses are implanted in the sulcus or angle and are non-adjustable. Summary of the invention

[0008] In aspect, an adjustable intraocular lens device for treating an eye is described, the device comprising a lens body having an adjustable membrane having a peripheral region and a surface configured to bend outward. The lens body has an annular element coupled to the perimeter of the adjustable membrane. The annular element has a shape-deformed membrane extending along the arc of the annular element. The shape-deformed membrane is configured to undergo displacement relative to the peripheral region of the adjustable membrane. The lens body has a stationary element having a peripheral region coupled to the annular element. The stationary element is positioned opposite to the adjustable membrane. The lens body has a fixed volume of optical fluid. The inner surface of the adjustable membrane, the inner surface of the shape-deformed membrane, and the inner surface of the stationary element together form a sealed cavity of the lens body filled with a fixed volume of optical fluid. The annular internal support is sealed with the peripheral region of the adjustable membrane on a first side and with the peripheral region of the stationary element on a second side. The stabilization system includes a haptic having an inner portion and a distal end. The inner portion of the haptic is coupled to an annular inner support near the perimeter region of the lens body. A force translation arm is included, the force translation arm having a first end and a free end, the first end being operatively coupled to the shape-deforming membrane of the lens body, the free end being operable and configured to engage the ciliary structure of the eye when the lens device is implanted in the eye so that the optical axis of the lens body is substantially aligned with the visual axis of the eye. The force translation arm is movable relative to the lens body to cause inward movement of the shape-deforming membrane.

[0009] The inward movement of the force conversion arm can cause the inward movement of the shape-deformed membrane and the deformation of the sealed cavity. The inward movement of the shape-deformed membrane can cause the optical fluid in the sealed cavity to squeeze the inner surface of the adjustable membrane. The internal support can mechanically isolate the optical components of the lens body from distortion during the movement of the force conversion arm relative to the lens body, and from distortion caused by stress on the stabilization system. The outer periphery of the internal support can include a concave geometric structure to avoid contact with the inner surface of the shape-deformed membrane during the inward movement of the shape-deformed membrane. The outer periphery of the internal support can include a feature with a wedge shape that tapers toward the central gap of the annular internal support. The internal support can form a partition within the sealed cavity, which divides the sealed cavity into a deformable region and a central region. The internal support can include a channel extending through the internal support to provide fluid communication between the deformable region and the central region of the sealed cavity. The deformable region can be located outside the visual zone of the lens body or inside the visual zone of the lens body. The inward movement of the shape-deformed membrane can deform the deformable region. The inward movement of the shape-deformable membrane compresses the sealed cavity. The optical fluid in the sealed cavity may be incompressible and presses against the inner surface of the adjustable membrane to cause an outward bending of the adjustable membrane when the shape-deformable membrane moves inward. The shape-deformable membrane may move a distance between about 50 μm and about 100 μm. The movement of the shape-deformable membrane may cause the refractive power of the lens body to change by at least ±3 diopters. The force applied to move the shape-deformable membrane may be between about 0.1 gf and about 1 gf.

[0010] The end of the haptic may also include an occlusal element that improves the fixation of the haptic within the eye. The occlusal element may include a grooved edge and / or a hole. The end of the haptic may extend above the force conversion arm. The end of the haptic may be positioned in a plane different from the force conversion arm. The end of the haptic may extend in a plane in front of the force conversion arm and may be configured to be positioned in the ciliary sulcus or capsular bag of the eye. The haptic may be flexible, foldable, or formed of a shape memory material. The lens body may include a deformable portion located outside the optic zone. The deformable portion may be a region of a shape-deformable membrane. The lens body may include a deformable portion located inside the optic zone. The deformable portion may be a region of a shape-deformable membrane. The shape-deformable membrane may be annular. The outward bend of the shape-changing membrane may be manually adjustable. The stationary element may be a stationary lens having an optical refractive power. The stationary lens may be positioned posteriorly relative to the eye, and the shape-changing membrane may be positioned anteriorly relative to the eye. The shape-changing membrane may have a constant thickness. The region of the shape changing membrane may be a region of reduced thickness that readily gives way upon increased internal pressure within the sealed cavity or upon pressure applied by the optical fluid to the inner surface of the shape changing membrane.

[0011] The optical fluid may include an incompressible liquid or gel with high transparency and transmission in the visible spectrum. The optical fluid may be a silicone oil or a fluorosilicone oil. The force conversion arm may have a length that is configured to extend between the shape-deforming membrane of the lens body and the ciliary structure. The length may be adjustable during insertion of the device into the eye. The adjustment may be mechanical or caused by rotation of the device relative to the eye. The perimeter of the device may have a maximum cross-sectional thickness that is sized to extend between a posterior region of the iris and an anterior region of the capsular bag.

[0012] In a related aspect, an adjustable intraocular lens device for treating an eye is provided, the device having a lens body. The lens body includes an adjustable membrane having a peripheral area and a surface configured to bend outwardly. An annular element is coupled to the perimeter of the adjustable membrane. The annular element has a shape-deformed membrane extending along the arc of the annular element. The shape-deformed membrane is configured to undergo displacement relative to the peripheral area of ​​the adjustable membrane. The device includes a stationary element having a peripheral area coupled to the annular element. The stationary element is positioned opposite to the adjustable membrane. The device includes a fixed volume of optical fluid. The inner surface of the adjustable membrane, the inner surface of the shape-deformed membrane, and the inner surface of the stationary element together form a sealed cavity of the lens body filled with a fixed volume of optical fluid. The device includes an annular inner support, which is sealed with the peripheral area of ​​the adjustable membrane on a first side and with the peripheral area of ​​the stationary element on a second side. The device includes a stabilization system including an annular ring structure coupled to an annular inner support and a flange extending radially outward from a posterior region of a lens body. The device includes a force translation arm having a first end and a free end, the first end being operatively coupled to a shape-deforming membrane of the lens body, the free end being operable and configured to engage a ciliary structure of the eye when the lens device is implanted in the eye so that an optical axis of the lens body is substantially aligned with a visual axis of the eye. The force translation arm is movable relative to the lens body to cause inward movement of the shape-deforming membrane.

[0013] The inward movement of the force conversion arm can cause the inward movement of the shape-deformed membrane, which causes the deformation of the sealed cavity. The inward movement of the shape-deformed membrane can cause the optical fluid in the sealed cavity to squeeze the inner surface of the adjustable membrane. The internal support can mechanically isolate the optical components of the lens body from distortion during the movement of the force conversion arm relative to the lens body, and from distortion caused by stress on the stabilization system. The outer periphery of the internal support can include a concave geometric structure to avoid contact with the inner surface of the shape-deformed membrane during the inward movement of the shape-deformed membrane. The outer periphery of the internal support can include a feature with a wedge shape that tapers toward the central gap of the annular internal support. The internal support can form a partition within the sealed cavity, which divides the sealed cavity into a deformable region and a central region. The internal support can include a channel extending through the internal support to provide fluid communication between the deformable region and the central region of the sealed cavity. The deformable region can be located outside the visual zone of the lens body. The deformable region can be located inside the visual zone of the lens body. The inward movement of the shape-deformed membrane can deform the deformable region. The inward movement of the shape-deformable membrane compresses the sealed cavity. The optical fluid in the sealed cavity may be incompressible and presses against the inner surface of the adjustable membrane to cause an outward bending of the adjustable membrane when the shape-deformable membrane moves inward. The shape-deformable membrane may move a distance between about 50 μm and about 100 μm. The movement of the shape-deformable membrane may cause the refractive power of the lens body to change by at least ±3 diopters. The force applied to move the shape-deformable membrane may be between about 0.1 gf and about 1 gf.

[0014] The flange extending radially outward may be positioned at a distance from the force conversion arm. The flange may be positioned in a front position relative to the lens body and the force conversion arm. The front surface of the flange may also be on the same plane as the force conversion arm. The more forward the flange is, the more it will pull the lens in the posterior direction. The force conversion arm may include a first force conversion arm and a second force conversion arm positioned relative to each other. The flange may include a first flange and a second flange positioned relative to each other. The first flange and the second flange may be positioned between the first force conversion arm and the second force conversion arm. The stabilization system may also include a groove located near the annular ring structure. The groove may be formed between the rear facing surface of the annular element and the front facing surface of the flange. The groove may be sized to receive the capsular bag edge formed by the capsulorhexis in the capsular bag. The flange may include an outer protrusion that curves toward the front. The flange may also include a blocker configured to provide access to the capsular bag. The blocker may be a gap extending through the flange or a depression in the outer perimeter of the flange.

[0015] The lens body may include a deformable portion located outside the optic zone. The deformable portion may be a region of a shape-deformable membrane. The lens body may include a deformable portion located inside the optic zone. The deformable portion may be a region of a shape-deformable membrane. The shape-deformable membrane may be annular. The outward curvature of the shape-deformable membrane may be manually adjustable after implantation of the device in the eye. The stationary element may be a stationary lens having optical refractive power. The stationary lens may be positioned posteriorly relative to the eye, and the shape-deformable membrane may be positioned anteriorly relative to the eye. The shape-deformable membrane may have a constant thickness. The region of the shape-deformable membrane may be a region of reduced thickness that is prone to give way when an increased internal pressure within the sealed cavity or when pressure is applied to the inner surface of the shape-deformable membrane by an optical fluid. The optical fluid may include an incompressible liquid or gel having high transparency and transmission in the visible spectrum. The optical fluid may be a silicone rubber oil or a fluorosilicone rubber oil. The force conversion arm may have a length that is configured to extend between the shape-deformable membrane of the lens body and the ciliary structure. The length may be adjustable during insertion of the device into the eye. The adjustment may be mechanical or caused by rotation of the device relative to the eye. The perimeter of the device may have a maximum cross-sectional thickness that is sized to extend between a posterior region of the iris and an anterior region of the capsular bag. Asymmetric inward movement of the force conversion arm relative to the lens body may effectuate a spherical outward curvature of the surface of the adjustable membrane. The device may include a single first conversion arm or may also include a second force conversion arm. The first force conversion arm and the second force conversion arm may be positioned symmetrically relative to each other and relative to the lens body.

[0016] In a related aspect, a method of implanting an accommodating intraocular lens (AIOL) device for treating an eye is described. The method includes the steps of: forming a capsulorhexis; and implanting the AIOL device.

[0017] The AIOL device may include a lens body. The lens body may include an adjustable membrane having a peripheral region and a surface configured to bend outwardly. The lens body may include an annular element coupled to the perimeter of the adjustable membrane. The annular element has a shape-deformable membrane extending along an arc of the annular element. The shape-deformable membrane is configured to undergo displacement relative to the peripheral region of the adjustable membrane. The lens body may include a stationary element having a peripheral region coupled to the annular element. The stationary element is positioned opposite the adjustable membrane. The lens body may include a fixed volume of optical fluid. The inner surface of the adjustable membrane, the inner surface of the shape-deformable membrane, and the inner surface of the stationary element may together form a sealed cavity of the lens body filled with a fixed volume of optical fluid. The device may include an annular inner support that is sealed with the peripheral region of the adjustable membrane on a first side and with the peripheral region of the stationary element on a second side. The device may include a stabilization system. The device may include a force-translating arm having a first end operatively coupled to the shape-deforming membrane of the lens body and a free end, the first end being operable and configured to engage the ciliary structure of the eye when the lens device is implanted in the eye so that the optical axis of the lens body is substantially aligned with the visual axis of the eye. The force-translating arm is movable relative to the lens body to cause inward movement of the shape-deforming membrane.

[0018] The stabilization system may include an annular ring structure coupled to an annular inner support and a flange extending radially outward from a posterior region of the lens body. The stabilization system may include a stabilization haptic having an inner portion and an end, the inner portion of the haptic being coupled to the annular inner support proximate a peripheral region of the lens body. The device may include two opposing force translation arms.

[0019] The method may also include the steps of positioning a stabilizing haptic within the ciliary sulcus to pull the device backwards away from the iris of the eye. The method may also include the steps of positioning a stabilizing haptic inside the capsular bag of the eye; and implanting a force conversion arm outside the capsular bag. The method may also include the steps of extending an edge of a capsular bag formed by the capsulorhexis over the anterior surface of the stabilizing haptic. The front of the device may be pushed away from the iris of the eye by the edge of the capsular bag. The method may also include the steps of orienting the device when implanted so that the posterior surface of the device is positioned behind the capsulorhexis and the force conversion arm remains in front of the capsulorhexis. The orienting device may include orienting the opposing force conversion arms horizontally in a medial-lateral manner relative to the eye to minimize displacement after implantation. Implanting the device may include rotating the device about its optical axis. The method may also include the steps of rotating the device about its optical axis but maintaining a gap between the outermost portions of the force conversion arms and the ciliary structure. The gap may have a size of approximately 0.1 mm. The method may also include the steps of rotating the device about its optical axis until the outermost portions of the force conversion arms are wedged into engagement with the ciliary structure. The ciliary structure can be the ciliary muscle of the eye. Rotating the device can adjust the engagement of the force conversion arm relative to the ciliary muscle. The device can be implanted by inserting the device through a corneal incision in the eye. The method can also include the steps of rolling or folding the device to an applicator and injecting through the corneal incision. The tip of the applicator can be approximately 2.5 mm in cross-sectional diameter. The device can be implanted by inserting the device through a scleral tunnel or a scleral incision. The capsulorhexis can be elliptical. The capsulorhexis can be approximately 6 mmx7 mm. The method can also include the steps of measuring the diameter of the ciliary body of the eye before implanting the AIOL device. The diameter can be measured by ultrasound biomicroscopy (UBM), optical coherence tomography (OCT), or other medical imaging techniques.

[0020] In some variations, one or more of the following may be optionally included in any feasible combination in the above method, device, apparatus, and system. More details of the apparatus, system, and method are set forth in the accompanying drawings and the following description. Other features and advantages are apparent from the description and the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0021] These and other aspects will now be described in detail with reference to the following drawings. In general, the drawings are not to scale, either absolutely or comparatively, but are intended to be illustrative. Moreover, the relative placement of features and elements may be modified for purposes of illustration clarity.

[0022] Figure 1A is a stereoscopic cutaway view of an eye with an opaque lens capsule;

[0023] Figure 1B It is a circular capsulorhexis with removal of the lens matrix by implanting a traditional 3-piece IOL. Figure 1AA three-dimensional cutaway view of the eye;

[0024] Figure 1C It is a cross-section of the front corner of the eye;

[0025] Figure 2A is a perspective view of an embodiment of an accommodating intraocular lens ("AIOL");

[0026] Figure 2B yes Figure 2A An exploded view of the AIOL;

[0027] Figure 2C yes Figure 2B A first lateral elevation view of the AIOL;

[0028] Figure 2D yes Figure 2B A second lateral elevation view of the AIOL;

[0029] Figure 2E It is taken along line EE. Figure 2D Cross-sectional view of AIOL;

[0030] Figure 2F It is taken along line FF. Figure 2A Cross-sectional view of AIOL;

[0031] FIG. 3A to FIG. 3B yes Figure 2A A stereoscopic view of the anterior lens of the AIOL;

[0032] Figure 3C It is taken along line CC. Figure 3B A cross-sectional view of the anterior lens portion;

[0033] Figures 3D to 3G are schematic diagrams of the anterior lens portion of various embodiments of an AIOL;

[0034] FIG. 4A to FIG. 4C An accommodating intraocular lens positioned within an eye relative to the iris and capsular bag is illustrated;

[0035] FIG. 5A to FIG. 5B is a cutaway, partial perspective view of an accommodating intraocular lens positioned within an eye;

[0036] Fig. 6A is an anterior view of the eye showing the entire capsulorhexis;

[0037] Figure 6B is a diagram showing an adjustable intraocular lens device positioned within an eye concealed by the iris Fig. 6A Front view of the eye in;

[0038] Fig. 7Ais a stereoscopic front view of an accommodative intraocular lens device with a stabilization system;

[0039] Figure 7B yes Fig. 7A A side elevation view of a lens device;

[0040] Figure 7C yes Fig. 7A A three-dimensional rear view of the lens device;

[0041] Fig.7D is a perspective front view of a lens device incorporating a cusp on the exterior of a force translation arm;

[0042] Figure 8 is a flow chart illustrating an embodiment of a method for lens selection;

[0043] Fig. 9 is a flow chart illustrating an embodiment of a method for intraoperative lens accommodation;

[0044] Fig.10 is a flow chart illustrating an embodiment of a method for postoperative lens accommodation;

[0045] FIG. 11A to FIG. 11B illustrates a top plan view and a side elevation view, respectively, of an embodiment of a lens having a plurality of visual indicia;

[0046] FIG. 11C to FIG. 11D illustrates a top plan view and a side elevation view, respectively, of an embodiment of a lens having a plurality of visual indicia;

[0047] FIG. 11E to FIG. 11L illustrating top plan and side elevation views of various configurations of visual indicia;

[0048] Fig.12 illustrates a cutaway partial perspective view of an accommodating intraocular lens device positioned within an eye and having a stabilization system that prevents contact between the capsular bag and the shape-deforming membrane;

[0049] Fig.13A A top view of an accommodating intraocular lens device is illustrated;

[0050] Fig. 13B The example is taken along the segment AA. Fig.13A A cross-sectional partial view of the device;

[0051] Fig. 13C The example is taken along the segment AA. Fig.13A Another embodiment of a cross-sectional partial view of a device;

[0052] Fig.14AA perspective view illustrating an embodiment of an accommodative intraocular lens device;

[0053] FIG. 14B to FIG. 14C They are exemplified Fig.14A A top plan view and a bottom plan view of the device;

[0054] FIG. 14D to FIG. 14E Illustrated Fig.14A A side elevation view of the device;

[0055] Fig.14F The following diagram illustrates a view taken along line FF. Fig. 14B A cross-sectional view of the device;

[0056] Figure 14G The example is taken along the line GG. Fig. 14B A sectional side view of a device;

[0057] Fig.14H Illustrated Fig.14A An exploded perspective view of the device;

[0058] Fig.14I illustrates a cutaway perspective view of an embodiment of a stabilization system;

[0059] Fig.15A A perspective view illustrating an embodiment of an accommodating intraocular lens device having a stabilization system;

[0060] Fig. 15B It is along Fig.15A A cross-sectional view taken along line BB;

[0061] Fig. 15C yes Fig.15A The stabilization system of the device;

[0062] Fig.16A A perspective view illustrating an embodiment of an accommodating intraocular lens device having a stabilization system;

[0063] Fig. 16B It is along Fig.16A A cross-sectional view taken along line BB;

[0064] Fig. 16C It is along Fig.16A A cross-sectional view taken along line CC;

[0065] Fig.16D yes Fig.16A The internal support and stabilization system of the device;

[0066] FIG. 16E to FIG. 16F yes Fig.16A A side view of the device;

[0067] Fig.17AA perspective view illustrating an embodiment of an accommodating intraocular lens device having a stabilization system;

[0068] Fig. 17B It is along Fig.17A A cross-sectional view taken along line BB;

[0069] Fig. 17C It is along Fig.17A A cross-sectional view taken along line CC;

[0070] Fig.17D yes Fig.17A The internal support of the device;

[0071] FIG. 17E to FIG. 17F yes Fig.17A A side view of the device;

[0072] Fig.18A A perspective view illustrating an embodiment of an accommodative intraocular lens device;

[0073] Fig.18B yes Fig.18A A top view of the device;

[0074] Fig.18C It is along Fig.18A A cross-sectional view taken along line CC;

[0075] Fig.19A illustrates a top view of an embodiment of an accommodating intraocular lens device with a stabilization system;

[0076] Fig.19B illustrates a top view of an embodiment of an accommodating intraocular lens device with a stabilization system;

[0077] Fig.19C Illustrated Fig.19B A three-dimensional diagram of the device;

[0078] Fig.19D It is along Fig.19C A cross-sectional view taken along line DD of ; and

[0079] Fig.19E It supports the rear lens. Fig.19B The internal bracket of the device.

[0080] It should be understood that the drawings herein are merely schematic and are not intended to be to scale. DETAILED DESCRIPTION

[0081] The present disclosure relates generally to the field of ophthalmology, and more specifically to ophthalmic devices, which include artificial lenses (IOLs), such as accommodative intraocular lenses (AIOLs). The dynamic properties of AIOLs allow a large, continuous range of focusing capabilities, just as in young, accommodative natural eyes. The devices described herein can provide focusing capabilities across a full range of accommodation from far to near by mechanically and functionally interacting with eye tissues (such as the ciliary body, ciliary processes, and zonules) that are typically used by the natural lens to achieve accommodation and loss of accommodation. The forces generated by these tissues are functionally converted to the devices described herein, which makes it more effective to adjust the refractive power changes. The devices described herein are constructed to adjust the size and fit at any time before, during, and after implantation. The devices described herein can be implanted in the eye to replace a diseased natural lens. However, it should be understood that the devices can also be implanted as a supplement to the natural lens (phakic patients) or an artificial lens previously implanted in the patient's capsular bag (pseudophakic patients).

[0082] Reference Figure 1A and Figure 1C , the human eye 10 includes a cornea 12, an iris 14, a sulcus 16, a ciliary muscle 18, a zonule 20, and a lens 21 contained within a capsular bag 22. Accommodation occurs when the ciliary muscle 18 contracts, thereby releasing static zonular tension on the equatorial region of the capsular bag 22. The release of zonular tension allows the inherent elasticity of the lens 21 to change to a more spherical or spherical shape, wherein the surface curvature of both the anterior lens surface 23 and the posterior lens surface 24 increases. In addition, the human lens may be afflicted with one or more disorders that degrade its function in the visual system. A common lens disorder is a cataract, which consists of an opacification of the normally transparent natural lens matrix 26. The opacification may be caused by the aging process, but may also be caused by genetics, diabetes, or trauma. Figure 1A The lens capsule is shown and includes a capsular bag 22 with an opacified lens nucleus 26 .

[0083] In cataract surgery, the patient's opaque lens is replaced with a clear lens implant or IOL 30. Figure 1B In conventional extracapsular cataract surgery as depicted, the lens matrix 26 is removed, leaving the thin walls of the anterior and posterior capsules intact along with the zonular ligament connections to the ciliary body and ciliary muscles 18. Figure 1B By way of example, the lens nucleus is removed by phacoemulsification with the aid of a circular capsulorrhexis, ie, the anterior portion 23 of the capsular bag is removed. Figure 1BA conventional 3-piece IOL 30 is depicted just after implantation in the capsular bag 22. After a healing period of days to weeks, the capsular bag 22 may effectively shrink-wrap around the conventional 3-piece IOL 30 due to collapse and subsequent fibrosis of the walls of the bag 22. Cataract surgery as practiced today causes irreparable loss of most of the natural structures of the eye that provide accommodation. The lens matrix 26 is completely lost, and the capsulorrhexis reduces the integrity of the capsular bag 22. Fibrosis of the capsular bag limits the dynamic movement of a lens placed in the bag. Thus, a conventional IOL (even one that claims to accommodate) may not provide sufficient axial lens spatial displacement or lens shape change along the optical axis to provide a sufficient amount of accommodation for near vision.

[0084] Combinations of lenses are known to be implanted to address refractive errors in the existing lens in the case of a phakic IOL, or to improve the refractive outcome of a standard IOL following cataract surgery in the case of a pseudophakic patient. These "piggyback" IOLs can be placed in front of a previously implanted IOL or natural lens to improve the refractive outcome of cataract surgery in the case of a pseudophakic eye, or to change the refractive state of the eye in the case of a phakic eye, usually to correct high myopia. Typically, these lenses are implanted in the ciliary sulcus and are non-accommodative. Figure 1C As best shown, 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.

[0085] Adjustable IOL is also beneficial to patients who do not suffer from cataract but wish to reduce their dependence on glasses and contact lenses for correcting their myopia, hyperopia and presbyopia. The intraocular lens for correcting the large errors of myopia, hyperopia and astigmatism is called "phakic intraocular lens", and is implanted without removing the lens. In some cases, even if there is no cataract, aphakic IOL (not phakic IOL) is implanted via lens removal and replacement surgery. During this surgery, in a process very similar to cataract surgery, the lens is taken out, and IOL replaces it. Like cataract surgery, refractive lens exchange relates to lens replacement, needs to form a small incision in the eye, so that the lens is inserted, uses local anesthesia, and continues approximately 30 minutes. Adjustable IOL described here can be used in the patient of refractive lens exchange.

[0086] Described herein are accommodative IOLs ("AIOLs") that can achieve a desired change in optical power, for example, within a range of 1 diopter (1D) to 3D up to approximately 5D or 6D. As will be described in more detail below, the devices described herein may include an accommodation mechanism including one or more force conversion arms that are configured to be positioned in the eye such that they control the movement of one or more ciliary structures and convert the movement into functional forces that drive shape changes in the lens body to accommodate and lose accommodation in a manner independent of capsular bag movement. The devices described herein may also include a stabilization system separate from the accommodation mechanism that is configured to be positioned, for example, within the capsular bag. The devices described herein mitigate known problems that often occur due to the above-mentioned capsular fibrosis. It should be understood that the devices described herein may be configured to control the movement of one or a combination of ciliary structures, including, but not limited to, ciliary muscles, ciliary bodies, ciliary processes, and zonules. For the sake of brevity, the term "ciliary structure" may be used herein to refer to any of one or more ciliary structures for which movement may be controlled by a force translating arm to effect accommodation of the lens body.

[0087] The device described herein can be implanted in the eye to replace the diseased natural lens. In some embodiments, the device described herein can be implanted via a refractive lens exchange surgery as an aphakic IOL. The intraocular lens described herein can also be implanted as a supplement to the natural lens (phakic patients) or the intraocular lens previously implanted in the patient's capsular bag (pseudophakic patients). The lens described herein can be used in combination with the intraocular lens described in U.S. Patent Publication Nos. 2009 / 0234449, 2009 / 0292355, 2012 / 0253459 and PCT Publication No. WO 2015 / 148673, and the entire text of each publication is incorporated herein by reference. It can be seen that the lens described herein can be used independently or as a so-called "piggyback" lens. The piggyback lens can be used to correct residual refractive errors in phakic or pseudophakic eyes. The primary IOL used to replace the natural lens is typically thicker and typically has a refractive power that can be in the range of ±10D to ±25D. Thicker, larger diopter lenses are typically not adjustable. In contrast, the supplemental lens does not need to provide significant optical refractive power to the system. The supplemental lens can be thinner than the primary IOL and can withstand more adjustments. Relative to the thick primary lens, the shape change and movement of the thinner lens are generally easier to achieve. The AIOL described here can be used independently and does not need to be used as a piggyback lens in combination with a natural lens or an implanted IOL. One or more components of the AIOL described here can be constructed to be positioned in the groove 16, close to the ciliary process, in the capsular bag 22, or a combination thereof.

[0088] Now go to FIG. 2A to FIG. 2F , an accommodative intraocular lens ("AIOL") 100 may include a lens body 105 and one or more force translation arms 115, each of which will be described in more detail below. As will be described in more detail below, the force translation arms 115 are configured to control the movement of one or more of the ciliary structures so that they are bi-directionally movable relative to the lens body 105 to achieve adjustable shape changes of the lens body 105. For example, and without limiting the present disclosure to any particular theory or mode of operation, the ciliary muscle 18 is a substantially annular structure or sphincter. In the natural environment, when the eye views an object at a distance, the ciliary muscle 18 within the ciliary body relaxes and the internal diameter of the ciliary muscle 18 increases. The ciliary processes continue to pull on the zonules 20, which in turn continue to pull the lens capsule 22 around the equator of the lens capsule. This causes the natural lens to flatten or become less convex, which is known as loss of accommodation. During accommodation, the ciliary muscles 18 contract, and the inner diameter of the circle formed by the ciliary muscles 18 (the ciliary circle diameter, CRD) becomes smaller. The ciliary processes release the tension on the zonules 20 so that the natural lens will spring back to its natural, more convex shape, and the eye can focus at near distances. This inward / forward movement of the ciliary muscles 18 (or one or more ciliary structures) can be controlled by the force translation arm 115 to cause a change in the shape of the lens body 105.

[0089] Still refer to FIG. 2A to FIG. 2F , the lens body 105 may include a generally ring-shaped peripheral region or annular element 104, an anterior lens 145, a stationary element 150, and a sealed cavity 155 filled with a fixed volume of optical fluid 156. The annular element 104 may include an anterior region, a posterior region 107, and an intervening equatorial region 108. The anterior region of the annular element 104 may be coupled to the anterior lens 145, and the posterior region of the annular element 104 may be coupled to the stationary element 150 such that the anterior lens 145 is positioned opposite the stationary element 150. FIG. 3A to FIG. 3B The rear end region 107 and the equatorial region 108 of the annular element 104 are also illustrated. The front lens 145 of the lens body 105 can include a central dynamic membrane 143 surrounded by a peripheral region 144. The peripheral region 144 can be coupled to or integral with the annular element 104 of the lens body 105. The dynamic membrane 143 of the front lens 145 is configured to undergo a shape change, while the peripheral region 144 can be configured to resist or not undergo a shape change. The static element 150, which can be a static lens, can also not undergo a shape change.

[0090] For the sake of understanding and clarity, the terms "anterior" and "posterior" as used herein are used to indicate a relative reference frame, position, direction, or orientation. The use of terms is not intended to be limited to the structure and / or implantation of the lens. For example, the orientation of the lens body 105 within the eye can be varied such that the anterior lens 145 can be positioned anteriorly along the optical axis A of the AIOL 100 and the stationary element 150 can be positioned posteriorly along the optical axis A of the AIOL 100 relative to the eye anatomy. However, the anterior lens 145 can be positioned posteriorly and the stationary element 150 can be positioned anteriorly relative to the eye anatomy.

[0091] The equatorial region 108 of the annular element 104 of the lens body 105 may include at least one shape-deforming membrane 140 (at FIG. 2E to FIG. 2F 143, the perimeter region 144 of the front lens 145, the shape-deformable membrane 140, and the inner surface of the stationary element 150 can collectively form a fixed-volume sealed cavity 155 that is filled with a fixed volume of an optical fluid 156. The shape-deformable membrane 140 is positioned adjacent to at least one force-translating arm 115. As will be described in more detail below, movement of the force-translating arm 115 causes movement of the shape-deformable membrane 140, thereby deforming the optical fluid 156 and the sealed cavity 155 to cause a change in the shape of the dynamic membrane 143 of the lens body 105.

[0092] The front lens 145 can be a flexible lens formed from an optically clear, low modulus polymeric material such as silicone rubber, polyurethane, or flexible acrylic. As mentioned above, the front lens 145 can include a peripheral region 144 that surrounds a central dynamic membrane 143 that is configured to bend outward. The dynamic membrane 143 can be positioned relative to the lens body 105 so that the optical axis A of the lens extends through the dynamic membrane 143. The peripheral region 144 of the front lens 145 surrounding the dynamic membrane 143 can be coupled to or integral with the annular element 104 of the lens body 105. In some embodiments, the peripheral region 144 of the front lens 145 can be coupled to or integral with the front end region of the annular element 104 (see Figure 3C). The front lens 145 can have a constant thickness so that it is a planar element. Alternatively, the front lens 145 can have a variable thickness. For example, the dynamic membrane 143 can have a reduced thickness compared to the peripheral area 144. The cross-sectional thickness of the dynamic membrane 143 that is thinner than the cross-sectional thickness of the peripheral area 144 can cause it to be more easily given way when a force is applied to its inner surface. For example, when an increased force is applied to the inner surface of the front lens 145 during deformation of the sealed cavity 155, the dynamic membrane 143 can bend outwardly along the optical axis A of the lens 100 while the peripheral area 144 maintains its shape. The dynamic membrane 143 can be configured to give way due to pressure applied to the interior surface of the front lens 145 by the optical fluid 156 within the sealed cavity 155, which causes an outward bending of the outer side (e.g., the front). The outer peripheral region 144 of the front lens 145 can have a greater thickness than the inner dynamic film 143 of the lens 145, and can be more resistant to reshaping under such internal pressure applied by the optical fluid 156 in the sealed cavity 155. The outer peripheral region 144 of the front lens 145 can also provide distance vision correction even when the inner dynamic film 143 is reshaped for near vision. The dynamic film 143 can have a substantially constant thickness. Alternatively, the dynamic film 143 can have a variable thickness. For example, the dynamic film 143 can have a linear gradient thickness, a curved gradient thickness, 2, 3 or more thicknesses with steps including a radial angle or a right angle. The dynamic film 143 can also include a plurality of materials, for example, a material configured to bend near the center of the dynamic film 143 and other materials configured to enhance the visual zone and limit distortion. Thus, the dynamic film 143 of the front lens 145 can be formed of a material that is relatively more susceptible to outward bending than the material of the outer peripheral region 144. The various regions of the lens 145 may be injection or compression molded to provide a relatively seamless and uninterrupted outer surface. The material of the regions may be generally consistent, but the dynamic membrane 143 may have a different stiffness or elasticity that allows it to bend further outward than the perimeter region 144.

[0093] The front lens 145 can be constructed to have a multifocal refractive power that changes to provide enhanced vision over a wider range of distances to the wearer of the AIOL described herein, for example, as described in U.S. Gazette No. 2009 / 0234449, which is incorporated herein by reference in its entirety. As used herein, a "viewing zone" generally refers to an area of ​​the lens body 105 that surrounds the optical axis A of the lens and is transparent to visual optics. As used herein, an "adjustable zone" generally refers to an area of ​​the lens body 105 that can undergo shape changes for focusing (e.g., a dynamic membrane 143). The viewing zone is constructed to have a corrective refractive power, but the entire viewing zone cannot have the same corrective refractive power. For example, the peripheral area 144 and the dynamic membrane 143 of the front lens can each be positioned within the viewing zone. The dynamic membrane 143 can have a corrective refractive power, while the peripheral area 144 can not have a corrective refractive power. Or, for example, the perimeter defined by the dynamic membrane 143 can have an optical power, and the perimeter region 144 can have an optical power greater or less than the power of the dynamic membrane 143. The dynamic membrane 143 can be equal to or less than the entire optical zone, which can produce a multifocal lens. The adjustable zone of the lens body 105 can be equal to or less than the entire optic zone.

[0094] As mentioned above and still with reference to FIG. 2A to FIG. 2F , the equatorial region 108 of the annular element 104 of the lens body 105 may include at least one shape-deformable membrane 140. The shape-deformable membrane 140 may extend along an arcuate length of the equatorial region 108 of the annular element 104 between the anterior region of the annular element 104 and the posterior region 107 of the annular element 104. The arcuate length may be sufficient (alone or in combination with other shape-deformable membranes 140) to cause a reactive shape change in the dynamic membrane 143 upon inward (or outward) movement of the deformable membrane 140. Movement of the shape-deformable membrane 140 in a generally inward direction toward the optical axis A of the AIOL 100 during accommodation may cause outward flexing or bending of the dynamic membrane 143 without affecting the overall optic zone diameter in any axis. The shape-deformable membrane 140 may be flexible so that it is movable and may undergo displacement relative to the annular element 104, the stationary element 150, and the anterior optic 145 of the lens body 105. For example, the shape-deformable membrane 140 can be more flexible than adjacent areas of the annular element 104, such that it is selectively movable relative to the annular element 104 and the perimeter area 144 of the front lens 145. The shape-deformable membrane 140 can have a resting position. The resting position of the shape-deformable membrane 140 can vary. In some embodiments, the resting position is when the shape-deformable membrane 140 is positioned substantially perpendicular to a plane P that is parallel to the front lens 145, such that it has a vertically oriented cross-sectional profile that is parallel to the optical axis A (see Figure 2FThe static position of the shape-deformed membrane 140 may also be angled relative to the optical axis A of the lens body 105. FIG. 13A to FIG. 13B As shown, the cross-section of the side deformation membrane 140 can be at an angle θ relative to the annular structure 104. 1 In some embodiments, the angle θ 1 Between 45 and 89 degrees. In some embodiments, θ 1 Alternatively, the cross-sectional profile of the deformable membrane 140 may be a curved structure protruding peripherally from the optical axis A of the lens body 105 (see Fig. 13C ). The peripherally protruding side deformable membrane 140 can protrude peripherally by 0.05 mm to 0.5 mm. In some embodiments, the curvilinear protrusion extends 0.1 mm to 0.3 mm away from the optical axis A of the lens body 105 relative to the equatorial region 108 of the annular structure 104. As will be described in more detail below, the shape and relative arrangement of one or more side deformable membranes 140 provide low force, low movement, high accommodation functions to the lens.

[0095] The movement of the shape-deformable membrane 140 may be a compression, collapse, depression, stretch, deformation, deflection, displacement, articulation, or other type of movement such that it moves in a first direction (such as generally toward the optical axis A of the lens body 105) when a force is applied to the shape-deformable membrane 140. The movement of the shape-deformable membrane 140 may be inside or outside the optic zone. Upon release of the force on the shape-deformable membrane 140, the membrane 140 and / or other components of the AIOL 100 (e.g., the optical fluid 156 filling the sealed cavity 155) may have an elastic memory such that the shape-deformable membrane 140 returns toward its resting position. Depending on the coupling of the AIOL 100 within the eye, the shape-deformable membrane 140 may also be pulled outwardly away from the optical axis A of the AIOL 100.

[0096] The shape-deformable membrane 140 is adjacent to or coupled to a corresponding force-converting arm 115. In some embodiments, as the force-converting arm 115 moves inwardly toward the optical axis A of the AIOL 100 due to contraction of the ciliary muscles, the force-converting arm 115 abuts against the outer surface of the shape-deformable membrane 140 and applies a force against the outer surface. Thus, the contact between the shape-deformable membrane 140 and the force-converting arm 115 can be a reversible contact, such that when the ciliary muscles contract, the force-converting arm 115 is pushed against the outer surface of the membrane 140 and inwardly pushing it. When the ciliary muscles relax, the shape-deformable membrane 140 returns to its resting position and the force-converting arm 115 returns to its resting position. The elastomeric properties of the movable component (i.e., the dynamic membrane and / or the shape-deformable membrane) can cause the force-converting arm 115 to return to its resting position. In other embodiments and as Figure 2FAs best shown, the shape deforming membrane 140 is coupled to or integral with its corresponding force translating arm 115. As with other embodiments, upon contraction of the ciliary muscles, the force translating arms 115 and shape deforming membrane 140 move in unison from a rest position to a generally inwardly displaced position, which causes the shape of the dynamic membrane 143 to change.

[0097] The number and arc length of each deformable membrane 140 can vary and can depend on the overall diameter and thickness of the device, the internal volume, the refractive index of the material, etc. In general, the annular element 104 provides sufficient rigidity and volume to the AIOL so that it can be handled and manipulated during implantation, while the deformable membrane 140 is flexible enough to allow the force conversion arm to change the shape of the sealed cavity 155. Depending on the overall diameter and thickness of the AIOL 100, the arc length of the shape deformable membrane 140 can be at least about 2 mm to about 8 mm. In some embodiments, the AIOL has a single shape deformable membrane 140 having an arc length between about 2 mm and about 8 mm. The single shape deformable membrane 140 can be designed to move about 10 μm to about 100 μm when a force as low as about 0.1 gram-force (gf) is applied to achieve at least 1D, or 1.5D, or 2D, or 2.5D, or 3D change of the dynamic membrane 143. In another embodiment, the AIOL can have two opposing shape-deformable membranes 140, each having an arc length between about 3 mm and about 5 mm. The shape-deformable membranes 140 can be designed to each move about 25 μm to about 100 μm when about 0.25 g-force to 1.0 g-force is applied to achieve at least a 1D change in the dynamic membrane 143. This is described in more detail below.

[0098] When a certain degree of force is applied, the shape deforming membrane 140 can move or collapse relative to the rest of the lens body. Typically, in order to cause sufficient diopter changes and with reliable optical devices, AIOLs are designed so that very low forces are sufficient to cause micron movements. The force applied to achieve movement of the dynamic membrane 143 of the lens body 105 to achieve accommodation can be as low as about 0.1 grams of force (gf). In some embodiments, the force applied can be between about 0.1 gf and about 5.0 gf, or between about 0.25 gf and about 1.0 gf, or between about 1.0 gf and about 1.5 gf. The movement of the deformable region of the lens body 105 (e.g., the shape deforming membrane 140) relative to the central portion of the lens body 105 (e.g., the dynamic membrane 143) in response to the force applied to achieve accommodation can be as small as about 50 μm. The movement of the shape-deformable membrane 140 of the lens body relative to the dynamic membrane 143 in response to the applied force can be between about 50 μm and about 500 μm, between about 50 μm and about 100 μm, between about 50 μm and about 150 μm, or between about 100 μm and about 150 μm. The range of applied forces (e.g., about 0.1 gf to about 1 gf) that cause these ranges of movement of the shape-deformable membrane 140 (e.g., 50 μm to 100 μm) can provide the devices described herein with an adjustability within a dynamic range greater than at least ±1D and preferably greater than about ±3 diopters (D). In some embodiments, for a movement of about 100 μm to 150 μm, the refractive power is between ±4D and ±6D. The devices described herein can have an adjustment range of at least ±1D for approximately 100 μm movement of the shape-deformable membrane 140 and approximately at least 0.25 gf of force applied to the shape-deformable membrane 140. In other embodiments, the devices can have an adjustment range of at least ±1D for approximately 50 μm movement and at least approximately 1.0 gf. In other embodiments, the devices can have an adjustment range of at least ±3D for approximately 100 μm movement and at least approximately 1.0 gf. In other embodiments, the devices can have an adjustment range of at least ±3D for approximately 50 μm movement and at least approximately 0.1 gf.

[0099] The micro-movement described here can be an asymmetric micro-movement (e.g., starting from one side of the device), or it can be a symmetric micro-movement starting from the opposite side of the device or uniformly distributed around the device relative to the optical axis. Regardless of whether the micro-movement is asymmetric or symmetric, the outward bending of the dynamic membrane 143 achieved is spherical. The micro-movement described here can also be the overall movement of the shape-deformed membrane 140. It can be seen that if the lens 100 includes a single shape-deformed membrane 140, the single membrane is capable of achieving the desired micro-movement (e.g., 50μm to 100μm) to achieve the desired diopter change (e.g., at least 1D to about 3D change). If the lens 100 includes two shape-deformed membranes 140, the membranes together are capable of achieving a movement between 50μm and 100μm to achieve at least 1D diopter change. The diopter change achieved by the device described here can be at least about 1D up to approximately 5D or 6D change. In some embodiments, for example, for patients with macular degeneration, the diopter change can be between 7D and 10D.

[0100] As mentioned above and still with reference to FIG. 2A to FIG. 2F , the lens body 105 may include a stationary element 150 coupled to the annular element 104. The stationary element 150 may be coupled to the rear end region 107 of the annular element 104, and the anterior lens 145 may be coupled to the front end region of the annular element 104, such that the stationary element 150 and the anterior lens 145 are positioned opposite to each other along the optical axis A of the AIOL 100. The manner in which the stationary element 150 is coupled to the annular element 104 may vary. For example, FIG. 2E to FIG. 2F As shown, the stationary element 150 can have a flat surface 151 on a first side, a curved surface 152 on a second opposite side, and a peripheral connecting ring 153 having a sealing surface 154 configured to mate with the rear end region 107 of the ring element 104. The stationary element 150 can be positioned outside the lens body 105 so that the flat surface 151 forms an inner surface of a sealed cavity 155 facing the lens body 105, and the curved surface 152 is in contact with the fluid of the eye. Alternatively, the stationary element 150 can be positioned inside the lens body 105 so that the flat surface 151 is in contact with the fluid of the eye, and the curved surface 152 forms an inner surface of the sealed cavity 155 facing the lens body 105. The sealing surface 154 of the peripheral connecting ring 153 can be connected to the rear end region 107 of the ring element 104, so that the peripheral connecting ring 153 is separated from the equatorial region 108 of the ring element 104 by a distance. The inner flat surface 151 of the stationary element 150 may abut against the inner surface of the peripheral region 144 of the front lens 145 .

[0101] The stationary element 150 can be optically transparent and provide a support function without affecting the optics of the AIOL 100. It can be seen that the stationary element 150 can have zero refractive power and can form a posterior support for the lens body 105. The stationary element 150 can be formed of silicone rubber, urethane, acrylic material, low modulus elastomer, or a combination thereof. The stationary element 150 can be or include a stationary lens corrected to an emmetropia state, or can have an appropriate refractive power (typically ±10D to ±30D) for aphakic patients. If the AIOL 100 is used in conjunction with a separate capsule IOL (e.g., such as a "piggyback" lens), the refractive power can be in the range of about -5D to about +5D to correct residual refraction or other optical aberrations in the optical system of the eye. The stationary element 150 can be plano-convex, convex-planar, biconvex, concave-convex, or any other combination. The stationary element 150 (or the lens positioned posteriorly) may be, for example, a toric lens, a spherical lens, an aspherical lens, a diffractive lens, or any combination of the two, in order to reduce or compensate for any aberrations associated with a flexible lens. The relative refractive indices of the stationary element 150 and the fluid surrounding it (whether the fluid is that of the eye or the optical fluid 156 within the sealed cavity 155) will determine the refractive power of the stationary element 150 for any given shape.

[0102] The AIOL 100 may include any of various combinations of reinforcements and / or supports that provide mechanical stability to the assembled lens 100. For example, the reinforcements may be in the peripheral region of the front lens 145 and / or the stationary element 150. The reinforcements may be optically transparent or opaque. The reinforcement structure may be formed of a rigid polymer, including, but not limited to, silicone rubber, polyurethane, PMMA, PVDF, PDMS, polyamide, polyimide, polypropylene, polycarbonate, etc., or a combination thereof. Other areas 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 sealed cavity 155 so that the support surrounds at least an outer portion of the lens body 105. For example, the outer support may be a generally annular element extending around the perimeter of the lens body 105 and having a central opening with which at least the dynamic membrane 143 of the front lens 145 is aligned so that the dynamic membrane 143 can be used to deform outwardly.

[0103] In other embodiments, the AIOL 100 includes one or more internal supports 110 that are located within the AIOL 100, such as within or facing the sealed cavity 155 of the lens body 105 (see FIG. 3A to FIG. 3C). One or more internal supports 110 can be a thickened portion on the inner side of the outer peripheral area 144 of the front lens 145. One or more internal supports 110 can also be a separate component coupled to the AIOL. One or more internal supports 110 can be coupled to the peripheral area 144 of the front lens 145 and / or embedded inside it. The internal support 110 can be used to mechanically isolate the optical components of the lens body 105 from optical distortion during movement of the moving parts of the AIOL 100 (such as the force conversion arm 115, the shape deformation membrane 140, and the dynamic membrane 143). The internal support 110 can be formed of a harder, thicker and / or more rigid material than the shape deformation membrane 140 or the dynamic membrane 143 of the front lens 145 to prevent unintentional movement of the moving parts of the device. Alternatively, the internal support 110 can be made of the same material as the shape deformation membrane 140 or the dynamic membrane 143 of the front lens 145, and the mechanical isolation function is completed due to the geometric structure of the support structure. The support 110 can be formed of a rigid polymer, including but not limited to silicone rubber, polyurethane, PMMA, PVDF, PDMS, polyamide, polyimide, polypropylene, polycarbonate, etc., or a combination thereof. For example, the internal support 110 can be a combination of multiple silicone rubbers or silicone rubber with a rigid or semi-rigid bone insert.

[0104] FIG. 3A to FIG. 3C An embodiment of a lens body 105 is illustrated that includes a peripheral region 144 having a plurality of internal supports 110a, 110b, 110c, 110d. The internal supports 110 may be relatively planar elements that are generally parallel to the central longitudinal plane P of the AIOL 100. The outer region of each support 110 may be positioned adjacent to the equatorial region 108 of the annular element 104 of the lens body 105 and extend inwardly toward the dynamic membrane 143 of the front optic 145. The outer region of the support 110 may be coupled to or integral with the equatorial region 108 of the annular element 104, or the outer region of the support 110 may be separate from the equatorial region 108 of the annular element 104. Figure 3A An embodiment is illustrated having a support 110b spaced apart from the equatorial region 108 of the ring element 104 near where the deformable membrane 140 extends along the arcuate length of the equatorial region 108. This separation from the deformable membrane 140 provides tolerance so that the deformable membrane 140 does not abut or contact the support 110b prematurely during the inward adjustment movement. As another example, Figure 3DThe outer regions of two inner supports 110a and 110c are shown supporting the lens body 105 along the arc of the outer peripheral region so that they are coupled to, integral with, or otherwise continuous with the equatorial region 108 of the ring element 104 of the lens body 105. The outer regions of the other two inner supports 110b and 110d are spaced a distance from the equatorial region 108 of the ring element 108 of the lens body 105, for example, near the location where the shape-deformed membrane 140 extends along the arc length of the ring element 104. This allows unimpeded inward movement of the shape-deformed membrane 140 and prevents contact between the inner supports 110b, 110d and the corresponding shape-deformed membrane 140. Similarly, Figure 3G The inner support 110 shows that the outer regions of the supports 110b, 110d are coupled to the equatorial region 108 of the annular element 104 of the lens body 105, are integral with it, or are otherwise continuous with it, while the outer regions of the supports 110a, 110c are separated by a distance from the equatorial region 108 of the annular element 104 of the lens body 105 near the position where the shape deformation membrane 140 is located.

[0105] The distribution of the internal support 110 on the peripheral area 144 of the front lens 145 can ensure that the support 110 does not interfere with the movement of the shape-deformed membrane 140. For example, Figure 3E The inner brackets 110a, 110b and 110c are shown to be distributed so that their outer regions are coupled to the annular element 104 between where the shape-deforming membrane 140 and the force-converting arm 115 are located. Figure 3F The inner supports 110a, 110b, 110c, and 110d of the illustrated embodiment are distributed such that the outer regions are coupled to the annular element 104 between where the shape-deforming membrane 140 and the force-translating arms 115 are located.

[0106] The distribution and spacing of the one or more inner supports 110 relative to the shape-deformable membrane 140 can minimize their contact with the moving parts of the lens, whether near the peripheral area of ​​the lens body 105 or near the central area of ​​the lens body 105. The shape of the inner support 110 can also minimize or limit the contact between the inner support 110 and the shape-deformable membrane 140. For example, Figure 3CAs best shown, the outer regions of the supports 110b, 110d can be chamfered near these outer regions where the supports are coupled to the annular element 104 so that the bevel 111 allows inward movement of the shape-deformed membrane 140 while avoiding contact between the membrane 140 and the outer perimeter of the supports. The bevel 111 can be a single bevel having an angle between about 10 and 80 degrees. It should be understood that the outer region of one or more supports need not include a bevel. Contact between the shape-deformed membrane 140 and one or more internal supports 110 can be avoided in other ways besides incorporating a bevel. For example, one or more supports 110 can be spaced a distance from the shape-deformed membrane 140 (e.g., along the perimeter and / or away from the perimeter) to avoid contact. The internal supports 110 can also have a length between the outer region to their inner region so that they extend a distance toward the center of the lens body (which provides stability and support), but generally do not reach the central dynamic membrane 143 of the front lens 145. It can be seen that the internal support 110 distributed around the lens body 105 can assist in creating a central step-down in thickness from the peripheral region 144 of the front lens 145 to the dynamic membrane 143 of the front lens 145.

[0107] As mentioned, the overall shape of each of the one or more supports 110 can vary. The internal supports 110 can have any of a variety of shapes, including, but not limited to, any of a polygon, a pyramid, a triangle, a rectangle, a square, a trapezoid, and a variety of curved shapes. In some embodiments, the one or more supports 110 can have a wider dimension near the perimeter of the lens body 105 and a narrower dimension near the central dynamic membrane 143 of the front lens 145. In other embodiments, the one or more supports 110 can be in the shape of an elongated rod. The peripheral area 144 of the front lens 145 can include a single internal support 110, two, three, four, five, six or more separate internal supports 110. Thus, the distribution, size, shape, and number of internal supports 110 can vary.

[0108] The lens body 105 may include a filled fixed volume sealed cavity 155, which is formed by the inner facing surfaces of the shape deforming membrane 140, the front lens 145, and the static element 150, and is filled with a fixed volume of optical fluid 156. The inner facing surfaces of the one or more inner supports 110 of the peripheral region 144 and the inner facing surface of the dynamic membrane 143 of the front lens 145 also form a part of the sealed cavity 155. Thus, the distribution, size, shape, and number of the one or more supports 110 affect the overall shape of the sealed cavity 155. Referring again to Figures 3A to 3G , adjacent internal brackets 110 may be spaced apart from each other by a distance, which forms a plurality of corridors 112 between the bracket posts that pass through the sealed cavity 155. The bracket posts may be formed to form a plurality of corridors 112 between the bracket posts. Figure 3D The narrower corridors 112 shown. These narrower corridors 112 can create a sealed cavity 155 having a general H or X shape. The columns of the stent can be formed to form a Figures 3E to 3G Wider corridors 112 are shown. These wider corridors 112 can create a sealed cavity 155 having a general shape of a plus sign, a cross, a star, a three-leaf, a four-leaf, a five-leaf, a kidney, or other shapes.

[0109] The optical fluid 156 filling the sealed cavity 155 can be an incompressible optical fluid, and the volume of the sealed cavity 155 can be substantially the same as the volume of the optical fluid 156. It can be seen that the optical fluid 156 filling the chamber 155 does not cause significant outward bending of either the dynamic membrane 143 or the deformable membrane 140 in a static state when no significant external force is applied to the AIOL 100. In some embodiments, the sealed cavity 155 may be slightly overfilled with the optical fluid 156 so that the dynamic membrane 143 has some outward bending when static. The slight static outward bending of the dynamic membrane 143 can reduce optical artifacts in the lens. However, no matter how much static outward bending exists in the dynamic membrane 143, the membrane 143 can still undergo additional outward bending when a compressive force is applied to the shape-deformed membrane 140 to provide accommodation. The pressure inside the sealed cavity 155 can be substantially equal to the pressure outside the sealed cavity 155. Because the optical fluid 156 in the sealed cavity 155 is incompressible, its shape deforms along with the shape of the chamber 155. The deformation of the chamber 155 in one position (e.g., micron inward movement of the shape-deformed membrane 140) causes the incompressible optical fluid 156 contained within the fixed volume sealed cavity 155 to squeeze the inner facing surface of the sealed cavity 155. The reactive deformation of the sealed cavity 155 occurs in the second position to produce sufficient adjustable changes. The dynamic membrane 143 of the front lens 145 is configured to bend outward when a force is applied (e.g., due to relative thickness and / or elasticity) compared to other portions of the front lens 145 (such as the peripheral area 144). Thus, the inward movement of the shape-deformed membrane 140 pushes the optical fluid 156 to deform along with the chamber 155 and squeeze the inner facing surface of the front lens 145. This causes the outer surface of the dynamic membrane 143 to bend outward and reshape so that the accommodative portion of the optic zone becomes more convex, which increases the refractive power of the AIOL 100. The inner support 110 provides sufficient stability to the lens body 105 so that the application of compressive forces to the shape deforming membrane 140 induces micron movements with minimal distortion of the optic.

[0110] The optical fluid 156 contained within the sealed cavity 155 of the lens body 105 remains substantially within the visual zone during rest in the unaccommodated resting state and during accommodation. The optical fluid 156 remains within the lens body 105 and can assist in the accommodative shape change of the dynamic membrane 143 by deforming the shape along with the deformation of the shape of the sealed cavity 155. It should be understood that this shape change of the dynamic membrane 143 can occur without actual flow of the optical fluid 156 within the sealed cavity 155, for example, from one part of the chamber to another location. Instead, the force applied to the shape-deformable membrane 140 causes the sealed cavity 155 to deform in a first area, which deformation may cause a reactive deformation of the sealed cavity 155 in at least a second area. The sealed cavity 155 has a fixed volume and is deformable. The optical fluid 156 filling the sealed cavity 155 changes shape along with and depending on the shape of the sealed cavity 155. Because the incompressible optical fluid 156 inside the sealed cavity 155 presses against the inner surface of the sealed cavity, inward movement of one or more portions of the chamber 155 (e.g., movement of the shape-deformable membrane 140 near the perimeter region of the lens body 105) can cause a reactive outward deformation of another portion of the chamber 155, such as an outward bulging of the dynamic membrane 143 of the anterior optic 145. The optical fluid 156 need not flow between the separate chambers of the AIOL, but rather, the optical fluid 156 can change shape along with the changing shape of the sealed cavity 155 to cause the accommodative portion of the optic zone of the anterior optic 145 to bend outward and increase the optical power of the AIOL 100. As described elsewhere herein, very small movements of the force-translating arm 115 (or a single force-translating arm 115 in the case of an asymmetric mechanism) cause an immediate small movement of the shape-deformable membrane 140 to change the shape of the dynamic membrane 143 and cause a sufficient change in power. Regardless of whether these very small movements are symmetrical due to at least a pair of opposing force translation arms 115 or asymmetrical due to a single force translation arm 115, the outward bending of the dynamic membrane 143 achieved is spherical and symmetrical.

[0111] Refer again FIG. 2A to FIG. 2F , the AIOL 100 may include one or more force translation arms 115 that are configured to move anteriorly and posteriorly relative to the lens body 105 to induce the diopter changes described elsewhere herein. The AIOL described herein is particularly suitable for controlling movement of the ciliary body applied directly to the force translation arms 115 that are positioned in close proximity to the ciliary structure into shape changes in the lens. The force translation arms 115 are configured to control and translate forces applied by the ciliary structure into shape changes of the movable portion of the lens body 105 described above. Each force translation arm 115 may include an outer contact portion 135 and an inner region 137 (see FIG. 1 ) that are operatively coupled to a peripheral or equatorial region of the lens body 105. FIG. 2E to FIG. 2F). The inner region 137 of each force conversion arm 115 can be positioned to contact or be adjacent to the shape deforming membrane 140 so that the force conversion arm 115 can move relative to the relaxed shape deforming membrane 140. For example, the force conversion arm 115 can be spaced apart from the membrane 140 during rest, move inwardly during adjustment to abut against the membrane 140, push the membrane 140 inwardly, and then when the force is released during loss of adjustment, the force conversion arm moves away from the membrane 140 to free the membrane 140 from the inward deformation force. It can be seen that the inner region 137 of the force conversion arm 115 can reversibly contact the shape deforming membrane 140 depending on whether an adjustable force is applied by the surrounding eye tissue. Alternatively, the inner region 137 of each force conversion arm 115 can be physically coupled to the outer surface of the shape deforming membrane 140 or integral therewith so that the force conversion arm 115 and the membrane 140 move in contact with each other.

[0112] In some embodiments, the inner region 137 of the force conversion arm 115 can have a cross-sectional thickness taken along a plane between the anterior surface of the lens body 105 and the posterior surface of the lens body 105 that is narrower than the cross-sectional thickness of the ring element 104 of the lens body 105 taken along the same plane. This can allow the inner region 137 of the force conversion arm 115 to displace the deformable membrane 140 inwardly a distance between the front and rear regions of the ring element 104 without abutting the ring element 104. The cross-sectional thickness of the inner region 137 of the force conversion arm 110 can also allow the inward movement of the arm 115 to occur without contacting the inner support 110 positioned adjacent to the deformable membrane 140 (see Figure 2F ). However, it should be understood that the cross-sectional thickness of the inner region 137 of the force conversion arm 115 need not be narrower than the annular element 104. The outer contact portion 135 of the force conversion arm 115 can, but need not, have a greater cross-sectional thickness than the inner region 137. However, it should be understood that the outer contact portion 135 of the force conversion arm 115 can also have the same cross-sectional thickness as the inner region 137. The outer contact portion 135 can also have a rounded or curved profile.

[0113] The contact portion 135 of force conversion arm 115 can include the feature of improving their connection with one or more in ciliary structure without causing damage.Usually, contact portion 135 avoids piercing ciliary structure or causing the wound to ciliary structure.In some embodiments, contact portion 135 can disturb ciliary structure while providing the surface preventing damage of meshing adjacent eye tissue, so that transfer movement can be made while not causing the wound to tissue itself.Outer contact portion 135 can also be molded to have one or more concave surfaces, depressions, grooves, teeth, combs or other surface features that improve, for example, contact with eye tissue (such as ciliary process or suspensory ligament protrusion (zonular process)) and / or interdental staggering.

[0114] In some embodiments, the outer contact portion 135 can include one or more concave surfaces 136. The concave surfaces 136 can have a contour that matches the contour of the region of the eye with which the contact portion 135 is associated. For example, when the AIOL 100 is implanted, the outer contact portion 135 of the force translating arm 115 can remain outside of the capsular bag 22 so that the contact portion 135 can abut, contact, engage, functionally couple to, or be in close association with one or more ciliary structures during accommodation and loss of accommodation. The concave surfaces 136 in the contact portion 135 can be sized to receive one or more portions of these ocular tissues. For example, as Figure 5A As shown, the concave surface 136 can engage the generally convex anatomy of the ciliary processes of the ciliary muscle 18. The convex anatomy of the eye can rest within the concave surface 136 of the outer contact portion 135, which provides better fixation of the AIOL 100 within the ciliary sulcus of the eye. The concave surface 136 can be centered within the outer contact portion 135 and symmetrical so that it creates upper and lower lips 134 of equal length on either side of the concave surface 136. Alternatively, the concave surface 136 can be slightly asymmetrical so that it creates a slightly longer upper lip 134 compared to a slightly shorter lower lip 134 (see FIG. 1 ). Figure 3B ). In some embodiments, the upper lip 134 can have a length sufficient to extend within a portion of the ciliary sulcus when the ciliary process is received by the concave surface 136. The lower lip 134 can also be longer than the upper lip 134. The outer surface of the contact portion 135 can also have a sharp or beveled edge on the upper and / or lower edge, so that the contact portion 135 has a general S-shape in cross-section. The outer contact portion 135 can also include more than a single concave surface 136, which creates a plurality of smaller grooves in the surface of the outer contact portion 135, which provides a surface texture, and the outer contact portion can also improve the friction between the force conversion arm 115 and the surrounding anatomical structure.

[0115] In some embodiments, the outer contact portion 135 may further include a plurality of prongs 138 extending rearwardly from the lower lip 134 of the force conversion arm 115 (see Fig.7D ). The tip 138 can have any of a variety of shapes (such as a cone, wedge, spear, hook, or other shapes) so that the tip 138 can extend between the suspensory ligaments and / or ciliary processes. The tip 138 can be, but is not necessarily, sharp. In some embodiments, the tip 138 can terminate at an atraumatic end so that they do not damage or tear eye tissue. The tip 138 can be flexible so that they can be more easily positioned between the suspensory ligaments or processes. In other embodiments, the tip 138 can be relatively rigid. In order to provide fixation of the force conversion arm 115 within the eye, the tip 138 can have a length sufficient to extend at least a distance between adjacent suspensory ligaments and / or processes.

[0116] The outer portion 135 can have an overall shape such that it extends along an arcuate length that is configured to engage with a corresponding arcuate length of the annular ciliary structure (see Figure 3A ). The arc length of the outer portion 135 can be longer than the arc length of the inner region 137, so that the force conversion arm 115 presents an outwardly flared shape. The arc length of the outer portion 135 can also be substantially the same as or slightly shorter than the arc length of the inner region 137, so that the force conversion arm 115 presents a rectangular shape or a tapered shape accordingly. In some embodiments, the force conversion arms 115 can be wider so that they have a longer arc length. Compared to narrower force conversion arms 115, wider arms 115 can cause more material to be displaced, even in the case of small (micro-range) inward movements of the arms 115. Force conversion arms 115 that extend along a larger circumference of the lens body (i.e., have a longer arc length) can be made thinner from the front to back direction and still cause the same amount of displacement with respect to each movement as arms extending along a shorter arc length, and the same is true for a larger thickness in the front to back direction. An advantage of a thinner force-translating arm 115 over a thicker arm is that it can be more easily folded or pushed into a "taco" shape for implantation through a smaller opening. Each force-translating arm 115 may include a region that is configured to provide adequate accommodation when moved inwardly and a cross-sectional dimension that encourages folding or bending of the arm 115, and thereby the AIOL 100. For example, in some embodiments, each arm 115 may have a central region 116 that has a thinner cross-sectional dimension in the anterior-to-posterior direction than the cross-sectional dimensions on either side of the central region 116 (see FIG. 1 ). FIG. 18A to FIG. 18B ). This allows the force translation arms 115 and thereby the AIOL 100 to fold down along the center along the optical axis A, which extends through these central regions 116.

[0117] In some embodiments, force conversion arm 115 is a single component having inner portion 137 and outer portion 135. Outer portion 135 may also be a separate component that is capped onto the peripheral end of force conversion arm 115 such that force conversion arm 115 is formed of two components coupled together. Fig.14FAn embodiment is illustrated in which the outer portion 135 is formed from a separate element capping the inner portion 137. The outer portion 135 can be manufactured to have a custom length suitable for a particular patient. For example, the inner portion 137 of the lens body 105 and the force conversion arm 115 can be manufactured as standard size components, and the outer portion 135 can be separately manufactured to have a thickness and / or length that is sized based on the measurements taken of the patient. Thus, coupling the customized outer portion 135 to the inner portion 137 provides an overall diameter of the lens 100 that is sized for the diameter of the particular patient. Further, the outer portion 135 can be formed of a material that is significantly softer than the material of the inner portion 137, so that as described elsewhere herein, the outer portion 135 provides a softer contact surface for delicate eye tissue that is adjacent to the outside of the capsular bag.

[0118] It should be understood that the various components and features described herein may be incorporated into the AIOL 100 in any of several combinations. As such, the description of a particular feature illustrated with reference to a particular figure is not intended to be limiting, as the feature may be incorporated into another embodiment of the AIOL 100 described herein. For example, the outer portion 135, which may be a separate component from the inner portion 137 in order to provide customization of length and fit, may, but need not, include any of the various features described for the outer portion 135, including, but not limited to, prongs, grooves, concavities, etc.

[0119] The AIOL 100 can be implanted so that the contact portion 135 of the force conversion arm 115 is in static contact or readily in contact with at least one of the ciliary structures (i.e., the suspensory ligament, the ciliary process, the ciliary muscle, and / or the ciliary body) when the ciliary muscle 18 contracts to drive the shape change of the optical device during accommodation and loss of accommodation. In a preferred embodiment, the AIOL 100 is implanted so that the contact portion 135 of the force conversion arm 115 is in static contact or ready to contact with the ciliary body apex. In another preferred embodiment, the AIOL 100 is implanted so that the contact portion 135 of the force conversion arm 115 is in static contact or ready to contact with the ciliary body. In some cases, the AIOL 100 is sized so that it is generally oversized relative to the ciliary structure. This can ensure contact between the force conversion arm 115 and the ciliary structure during accommodation. In some embodiments, the AIOL is oversized by at least about 0.80 mm, 0.75 mm, 0.70 mm, 0.65 mm, 0.60 mm, 0.55 mm, or 0.05 mm to ensure ciliary contact with the force translation arm 115. It should be understood that the AIOL does not need to be oversized, and in some cases, oversizing of the AIOL can be avoided. For example, accurate measurement of the ciliary diameter at the plane of the AIOL can be relied upon to ensure that the fit of the AIOL is appropriate and optimized for a particular patient.

[0120] The force conversion arm 115 described herein can have a fixed length. The fixed length force conversion arm 115 can have a selected size that is suitable for each patient based on preoperative measurements. Alternatively, the length of the force conversion arm 115 can be adjustable. The adjustment of the length of the force conversion arm 115 can be performed at any time before, during, or after insertion into the eye. Together with the adjustment of the length of the force conversion arm 115, the position of the force conversion arm 115 relative to one or more ciliary structures can be changed. In some embodiments, the force conversion arm 115 can extend generally parallel to the plane of the AIOL 100, or can be angled relative to the plane of the AIOL 100.

[0121] The contraction of the ciliary muscles and the inward / forward movement of one or more of the ciliary structures toward the optical axis A of the AIOL 100 exerts a force against the contact portion 135 of the force conversion arm 115. The force conversion arm 115 is sufficiently rigid relative to the deformable membrane 140 to transfer the force applied by one or more moving parts of the eye (e.g., one or more ciliary structures) to cause the inward movement of the deformable membrane 140. In some embodiments, the force conversion arm 115 can be a rigid polymer such as silicone rubber, polyurethane, PMMA, PVDF, PDMS, polyamide, polyimide, polypropylene, polycarbonate, etc., or a combination thereof. In some embodiments, the force conversion arm 115 can be an element reinforced with a rigid material. For example, the force conversion arm 115 can have an inner rigid element such as silicone rubber elastomer, polyurethane, PMMA, PVDF, PDMS, polyamide, polyimide, polypropylene, polycarbonate, etc., which is covered by a softer material such as silicone rubber elastomer, polyamide, or a hydrophobic or hydrophilic flexible acrylic material. In some embodiments, the force conversion arm 115 may include an inner rigid element that extends between the outer contact portion 135 and the inner contact portion 137. In other embodiments, the inner rigid element extends between the outer portion 135 and the inner portion 137 along only a portion of the length of the force conversion arm 115. For example, the inner rigid element need not extend all the way to the outer contact portion 135, where the force conversion arm 115 contacts the ciliary structure to provide a softer and atraumatic surface so as not to damage the ciliary structure. The inner rigid element also need not extend all the way to the inner contact portion 137 so that the inner rigid element of the force conversion arm 115 remains outside the lens body 105 when the shape-deformed membrane 140 is moved inwardly by the force conversion arm 115. Typically, the force conversion arm 115 is formed of a material and / or dimensioned in a manner such that the force conversion arm 115 maintains their shape when forces are applied to them by the ciliary structure and the force conversion arm 115 does not collapse or deform when transferring the force to move the shape-deformed membrane 140. As described above, movement of the shape deforming membrane 140 causes a shape change in the sealed cavity 155, which changes the shape of the optical fluid filling the sealed cavity 155. As the optical fluid presses against the inner surface of the lens body 105, it causes an outward bending of the dynamic membrane 143 of the front lens 145. This outward bending causes a more spherical or convex shape of the lens body 105, thereby increasing the refractive power of the lens for near vision focusing.

[0122] The number of force conversion arms 115 and shape deformation membranes 140 may vary. FIG. 2A to FIG. 2FAs shown, the AIOL 100 may include two force-translating arms 115 positioned on opposite sides of the device adjacent to the two shape-deformable membranes 140. Alternatively, the AIOL 100 may include a single force-translating arm 115 that is movable in a manner sufficient to change the shape of the dynamic membrane 143 of the front lens 145 to achieve the desired diopter change. The AIOL 100 may also include more than two arms distributed around the lens body 105, such as three, four, or more force-translating arms 115. The force-translating arms 115 may be distributed around the perimeter of the AIOL 100 in a symmetrical manner or in an asymmetrical manner. It should be understood that the number of force-translating arms 115 need not match the number of shape-deformable membranes 140. For example, the AIOL 100 may include: a single shape-deformable membrane 140 extending along an arcuate length of the equatorial region 108 of the annular element 104; and more than one force-translation arm 115, which is configured to contact or couple to different regions of the single shape-deformable membrane 140.

[0123] The AIOL 100 may also include a stabilization system 120. The stabilization system 120 may be configured to maintain alignment of the optics of the device and resist movement of the device once the device is implanted and undergoes shape changes. Unlike the force translation arm 115, the stabilization system 120 does not cause adjustment of the AIOL 100. And because the force translation arm 115 is independent of the stabilization system 120 and is not necessary to fix, center, stabilize, and / or maintain the AIOL 100 in a proper position within the eye, the AIOL 100 described herein may incorporate a single asymmetric force translation arm 115 sufficient to provide dynamic membrane power changes.

[0124] The stabilization system 120 can be coupled to a peripheral region of the device 100, for example, bonded, coupled, or molded as part of the lens body 105, or coupled to an external support (if present). In some embodiments, the stabilization system 120 can be coupled to a posterior region of the device 100 so that it can provide stabilization and engagement with a portion of the capsular bag, such as with the anterior capsule.

[0125] Stabilization system 120 can vary. In some embodiments, stabilization system 120 includes one or more of a stabilizing tactile member, a stationary tactile member, a ring-like element, a flange element, or other stabilizing features. In some embodiments, stabilization system 120 can include a ring-like structure 171 having a flange 172 extending outward from a region of the ring-like structure 171, such as a rear end (see, e.g., FIG. 7A to FIG. 7C , FIG. 11A to FIG. 11L , FIG. 14A to FIG. 14H , FIG. 15A to FIG. 15C ,as well as FIG. 16A to FIG. 16F). The front end of the ring-like structure 171 can be coupled to the peripheral connecting ring 153 of the stationary element 150 so that the flange 172 on the rear end thereof extends behind the lens body 105. For example, the outer diameter of the ring-like structure 171 can be sized to be received within the inner diameter of the peripheral connecting ring 153 of the stationary element 150. However, it should be understood that other coupling structures between the stabilization system 120 and the lens body 105 are considered here. The ring-like structure 171 and the flange 172 can be coupled to or integral with other parts of the lens body 105, such as the annular element 104 or the annular internal support, and the ring-like structure and the flange do not need to be coupled to the stationary element 150. Typically, the coupling of the stabilization system 120 to the lens body 105 is such that the flange 172 is positioned in a rear position relative to the lens body 105 and the force conversion arm 115 along the optical axis A of the lens 100. Additionally, the stabilization system 120 and its components (such as flange 172) are coupled to the lens body 105 in a manner that does not interfere with the movement of the force translation arm 115 and the shape deforming membrane 140. For example, Fig. 7A , Fig.11A , Fig.14A , Fig.15A as well as Fig.16A As shown, the stabilization ring 171 may include a pair of flanges 172 that extend outwardly from the periphery of the lens body 105 between the locations of the force translation arms 115. In some embodiments, the flanges 172 may have an outer ridge, but this is because they are positioned at 90 degrees relative to the force translation arms 115, which can provide stability without interfering with the accommodative movement of the arms 115. Forces applied to the flanges 172 or ring-like structures 171 are not transferred by the stabilization system 120 to the lens 100 in a manner that causes deformation of the sealing cavity 155 or a change in the shape of the dynamic membrane 143. The flanges 172 may be positioned in a posterior position relative to the lens body 105 and the force translation arms 115. The anterior surface of the flanges 172 may also be in the same plane as the force translation arms 115. The more anterior the flanges 172 are, the more the flanges 172 can pull the lens body 105 in the posterior direction.

[0126] The stabilization system 120 may also include a ring 173 protruding from its rear surface. For example, the ring 173 may extend from the rear surface of the ring structure 171 having the flange 172. The ring 173 may have a narrow, generally square edge 176 (see Fig.14I). The ring 173 of the stabilization system 120 can be positioned relative to the lens 100 so that it can be positioned within the capsular bag 22. The ring 173 can have an inner diameter of approximately 5 mm and an outer diameter of approximately 6 mm, thereby producing a flat posterior surface of approximately 1 mm. The ring 173 can have a height between approximately 50 μm and approximately 700 μm. As can be seen, the edge 176 of the ring 173 is generally square or rectangular. The edge 176 of the ring 173 can create a 360 degree surface for contacting the posterior capsule in close proximity. The edge 176 of the ring 173 can provide a barrier to the migration of lens epithelial cells toward the central posterior capsule that contributes to posterior capsule opacification (PCO). The edge 176 of the ring 173 can have other shapes besides square, however, the edge 176 provides a sharper contact point between the lens 100 and the posterior capsule to prevent tissue with PCO.

[0127] It should be understood that other portions of the lens 100, such as the lens body 105, the stationary element 150, or other areas of the stabilization system 120, can incorporate similar edges to engage the posterior capsule in such a manner that the risk of PCO is minimized. Additionally, in order to maintain a healthy capsular environment with limited PCO, a combination of features can be used to promote fluid flow in the capsular bag and around the lens. For example, the stabilization system 120 can engage the lens equatorial portion while the stationary element 150 and the lens body 105 engage the anterior and posterior capsules to prevent collapse of the capsule wall. In another embodiment, the stabilization system 120 can be configured to engage multiple capsular surfaces to keep the capsule open without assistance from other lens components.

[0128] The ring structure 171 of the stabilization system 120 can be generally cylindrical in shape, and the flange 172 can have generally oval or elliptical outer dimensions such that the flange 172 protrudes beyond the outer diameter of the ring structure 171 in at least two areas along the perimeter of the lens body 105. The front end of the ring structure 171 can be coupled to the peripheral connecting ring 153 of the stationary element 150, and the flange 172 can be sized to remain outside the lens body 105 on the rear end and protrude beyond the outer diameter of the lens body 105 in at least two areas. The at least two areas where the flange 172 protrudes beyond the outer diameter of the lens body 105 can be oriented relative to the lens body 105 so that the flange 172 provides stabilizing support relative to the force translation arm 115. For example, if the lens 100 includes a pair of opposing force-translating arms 115, the flange 172 can be positioned relative to the lens body 105 such that the flange 172 extends outwardly from the lens body 105 between the locations of the opposing force-translating arms 115 (see, e.g., Fig. 7A , FIG. 11A to FIG. 11B , FIG. 14A to FIG. 14C , FIG. 15A to FIG. 15C ,as well as Fig.16A). It should be understood that flange 172 can have other shapes besides oval and elliptical. For example, flange 172 can also be cylindrical and have an outer diameter that is configured to extend outwardly beyond the outer diameter of ring structure 171 and lens body 105 along 360 degrees. Alternatively, flange 172 can have more than two positions where it extends beyond the outer diameter of lens body 105, such as three, four, five or more positions. Ring structure 171 and flange 172 can provide 360-degree support and stability to lens 100.

[0129] As mentioned above, the ring-like structure 171 can incorporate a pair of flanges 172 that are positioned between or rotated 90 degrees relative to the position of the force conversion arm 115. The outermost edges of the flanges 172 can be convex forward so that a channel or groove 174 is formed near the inner area of ​​the flange 172 (e.g., between the rear surface of the ring element 104 and the front surface of the flange 172) (see FIG. 15A to FIG. 15C and FIG. 16A to FIG. 16B ). When the ring structure 171 is positioned within the capsular bag, this outer ridge of the flange 172 can engage the posterior interior surface of the capsular bag to help push the lens 100 in a posterior direction relative to the bag. In addition, the edge of the capsulorhexis can be received and retained within the groove 174. In some embodiments, the edge can be captured between the groove 174 of the flange 172 and the posterior facing edge of the ring element 104.

[0130] As described elsewhere herein, the force-translating arm 115 is configured to extend outside of the capsular bag 22 to engage the ciliary structure so that physiological forces from the contraction of the ciliary muscles can cause changes in the optical refractive power of the lens in a manner independent of the capsular structure or movement of the capsular bag 22. The flange 172 extending outward from the rear end region 107 of the annular element 104 can be retained inside the capsular bag 22, while the force-translating arm 115 extending generally from the equatorial region 108 or the front end region of the annular element 104 extends outside the capsular bag 22 to engage the ciliary structure. The flange 172 can be configured to engage the posterior facing surface of the edge of the capsular bag 22 formed by the anterior capsulorhexis C to improve the fixation of the lens 100 within the eye. The edge of the capsular bag 22 formed by the capsulorhexis C can be received within a groove 174 formed between the posterior surface of the annular element 104 and the anterior surface of the flange 172 (see Figure 7B as well as FIG. 14D to FIG. 14G ). Thus, the capsulorhexis C can assist in fixing the position of the lens.

[0131] The flange 172 can have a blockage that provides flexibility during handling and allows the surgeon to access the portion of the lens 100 and capsular bag 22 behind the flange 172. This may be preferred in situations where the surgeon needs to clean the capsular bag, remove viscoelastics, adjust the position of the lens, or any other procedure where the surgeon uses tools to manipulate the environment behind the AIOL. In some embodiments, the blockage may include one or more slits 175 extending through the area of ​​the flange 172 (see Fig.11A , and see Fig.16A , Fig.16D The blocker may also include one or more recesses 178 or grooves or other features at the outer perimeter of the flange 172 (see FIG. 14A to FIG. 14H ). Recess 178 can allow for easy insertion into the eye, and also allow for withdrawal of the viscoelastic from within capsular bag 22 using a cannula or other tools known in the art.

[0132] Because the shape-deformed membrane 140 is sensitive to small forces imparted by the ciliary structures via the force-translating arms 115, implanting the posterior region of the lens 100 into the anterior capsule segment may cause unintentional contact between the edge of the capsulorhexis C and the shape-deformed membrane 140. Such contact may cause a change in refractive power with undesirable optical consequences. Thus, the stabilization system 120 may stabilize the position of the lens within the eye, yet keep the shape-deformed membrane 140 from contacting the edge of the capsulorhexis C. Typically upon implantation, the plane of the capsulorhexis C will intersect the plane of the shape-deformed membrane 140. At least a portion of the stabilization system 120 may be designed to extend between the location where the edge of the shape-deformed membrane 140 and the capsulorhexis C intersect. Thus, a portion of the stabilization system 120 provides a surface for the edge of the capsulorhexis C to contact, thereby preventing the edge from contacting the shape-deformed membrane 140 to cause an optical or accommodative change in the AIOL 100.

[0133] Fig.12An embodiment of a stabilization system 120 is illustrated that prevents contact between the edge of the capsulorhexis C and the shape-deforming membrane 140. The stabilization system 120 can be positioned proximate to the posterior region of the lens body 105. The stabilization system 120 can include a shield 1205 having a protective outer edge 1210 positioned at its outermost terminus. It should be understood that the actual shape and configuration of the shield 1205 and the outer edge 1210 can vary. The shield 1205 can be a generally annular element configured to be positioned outside of the lens body 105. The shield 1205 can be coupled to the outer perimeter of the posterior side of the lens body 105. The shield 1205 can be coupled to or otherwise extend from the peripheral connection ring 154 of the stationary element 150 over at least a portion of the posterior region 107 of the annular element 104 and the equatorial region 108 of the annular element 104. Thus, the guard 1205 forms an annular cap over a peripheral region on the posterior facing surface of the lens body 105 and at least a portion of the equatorial region 108 of the annular element 104. Because the shape deforming membrane 140 extends along the annular length of the equatorial region 108 of the annular element, the guard 1205 also covers at least a portion of the shape deforming membrane 140. The protective rim 1210 can extend outwardly from the region of the guard 1205 where the guard 1205 covers a portion of the shape deforming membrane 140, thereby forming an angle relative to the region of the guard 1205. The region of the guard 1205 that covers a portion of the shape deforming membrane 140 can be aligned generally parallel to the shape deforming membrane 140 so that it covers but avoids contacting the shape deforming membrane 140. The protective rim 1210 can have a width such that it extends along at least the length of the lower surface (or rear-facing surface) of the force-translating arm 115 near its inner contact region 137 where the protective rim abuts or is coupled to the shape-deformed membrane 140. The protective rim 1210 can extend generally parallel to the length of the force-translating arm 115 along which it extends such that the protective rim 1210 forms an approximately 90 degree angle relative to where it extends outwardly from the guard 1205. The width of the protective rim 1210 can vary, and thus the length it extends under the force-translating arm 115 can vary. Typically, the width of the protective rim 1210, together with the guard 1205 from which it extends, is sufficient to engage a portion of the anterior surface of the capsular bag 22 such that the edge of the capsular bag C sits in the region where the protective rim 1210 and the guard 1205 meet. This prevents contact between the shape-deformed membrane 140 and the edge of the capsulorhexis C. It should be understood that the stabilization system 120 may include a combination of the protective rim 1210 and one or more flanges 172 as described above.Thus, the stabilization system 120 can have one or more components (e.g., a protective outer edge 1210) that are constructed to remain outside the capsular bag 22 such that the components extend over the edge of the capsular rhexis C, and the stabilization system 120 can have one or more components (e.g., a flange 172 or a stabilizing tactile member) that are constructed to remain inside the capsular bag 22 such that the edge of the capsular rhexis C extends over the components.

[0134] In some embodiments, the stabilization system 120 includes one or more stabilization haptics 160 (see, e.g., FIG. 2B to FIG. 2F , FIG. 17A to FIG. 17F , FIG. 19A to FIG. 19E ). The stabilizing haptic 160 can be coupled to or integral with the annular element 104 of the lens body 105 at a position remote from at least one shape-deformable membrane 140 or in a manner that does not interfere with the movement of the shape-deformable membrane 140. For example, the AIOL 100 can include two opposing shape-deformable membranes 140, and the stabilizing system 120 can incorporate a pair of stabilizing haptics 160 that are positioned on or coupled to the annular element 104 at a position between the two shape-deformable membranes 140. It can be seen that the forces applied to the haptics 160 of the stabilizing system 120 during implantation are not transferred by the stabilizing system 120 to the AIOL 100 in a manner that causes deformation of the sealing cavity 155 or a change in the shape of the dynamic membrane 143. The inner portion 161 of the haptic 160 can be coupled to or integral with the annular element 104 so that the haptic 160 extends from the equatorial region 108 of the annular element 104 between the front end region and the rear end region 107 of the annular element 104. Alternatively, the inner portion 161 of the haptic 160 can be coupled to or integral with a region of the annular element 104 that is located further anteriorly or posteriorly along the optical axis of the AIOL, such as Figure 2C Alternatively, the haptics 160 can be connected to or integrated with the stationary element 150 as described above. In some embodiments, the haptics 160 are positioned relative to the lens body 105 so that they extend outwardly from the lens body 105 at a position that is generally more posteriorly oriented than the force conversion arms 115 (see Figure 2A ). In this embodiment, one or more of the stabilizing haptics 160 can be positioned and engaged within the capsular bag 22 to maintain stability of the device 100 during movement of the force-translating arms 115 to prevent and / or limit anterior, posterior, and rotational movement of the device. In other embodiments, the haptics 160 are positioned relative to the lens body 105 such that they extend outwardly from the lens body 105 at a position that is generally more anteriorly oriented than the force-translating arms 115 (see Fig.17A and Fig.19C). In this embodiment, one or more stabilizing haptics 160 can be positioned and engaged within the ciliary sulcus to maintain stability of the device 100 during movement of the force-translating arms 115 to prevent and / or limit anterior and rotational movement of the device. In some embodiments, each stabilizing haptic 160 is positioned relative to the force-translating arms 115 such that an inner region 161 of the haptic 160 is coupled proximate a first side of a first force-translating arm 115 and a distal end 162 thereof extends around the circumference of the AIOL 100 away from the first side of the first force-translating arm 115 toward the other force-translating arm 115 (see Fig.17A In other embodiments, each stabilizing tactile member 160 is disposed relative to the force conversion arm 115 such that the inner region 161 is coupled adjacent to a first side of the first force conversion arm 115 and its distal end 162 extends from the first side toward an opposite location of the same force conversion arm 115 above the force conversion arm 115 (see Fig.19A ). The ends 162 are positioned so that they extend above the force conversion arms 115 of the AIOL 100 to reduce the width of the AIOL 100, which provides easier insertion and manipulation of the AIOL 100 into the proper position in the eye. In either embodiment, the stabilizing haptics 160 can be angled forwardly relative to the plane of the force conversion arms 115 so that their ends 162 can engage the ciliary sulcus when the AIOL 100 is at least partially positioned within the capsular bag. The stabilizing haptics 160 can then push the AIOL 100 further into the capsular bag in a posterior direction. Regardless of whether the ends 162 of the stabilizing haptics 160 extend above or within the same quadrant as the force conversion arms 115 or extend between the force conversion arms 115, the haptics 160 assist in preventing the force conversion arms 115 from contacting the iris by applying a rearwardly directed pressure to the AIOL 100.

[0135] Each haptic 160 can loop along a curve such that the haptics 160 are configured to engage eye tissue along a greater portion of their overall length. The haptics 160 can be coaxial or coplanar with the force conversion arm 115. The haptics 160 can also be positioned along an axis different from the force conversion arm 115, for example, offset from or angled relative to the force conversion arm 115. In some embodiments, the haptics 160 can be positioned at an angle in the range of 0 to 20 degrees or other degrees relative to the force conversion arm 115. Each haptic 160 can be angled away from the plane of the AIOL such that the end 162 of each haptic 160 sits on a different plane than the interior region 161 of the haptic 160 near where it couples to the annular element 104. For example, FIG. 2B to FIG. 2DAn embodiment of an AIOL having two haptics 160 and two opposing force translation arms 115 is shown. The force translation arms 115 in this embodiment are coupled generally centrally relative to the ring element 104 of the lens body 105 such that each force translation arm 115 is disposed generally along the center plane of the AIOL between the inner contact portion 137 and the outer contact portion 135. Each of the two haptics 160 in this embodiment is coupled to a region of the ring element 104 between the two force translation arms 115. An inner region 161 of each haptic 160 is positioned or coupled to the ring element 104 at a position slightly rearward of the center plane of the ring element 104 between the anterior and posterior surfaces. Each haptic 160 is curved from the inner region 161 toward a distal end 162 such that the distal end 162 of each haptic 160 is positioned on a plane that is forward of the plane of the inner region 161 of the haptic 160. This results in the contact portions 135 of the force-translating arms 115 being positioned more anteriorly than the distal ends 162 of the haptics 160 so that they can be implanted in different anatomical locations within the eye. For example, the contact portions 135 of the force-translating arms 115 can be positioned in the eye so that they make contact with the ciliary body apex 18 or the ciliary sulcus, and the haptics 160 can extend further posteriorly into the capsular bag 22 than the force-translating arms 115. However, it should be understood that one or more haptics 160 can be positioned in the same plane as the force-translating arms 115. Alternatively, the haptics 160 can be angled anteriorly in order to bias the lens in a posterior direction (see FIG. 1 ). FIG. 17A to FIG. 17F as well as Fig.19C ). To minimize contact with the iris, a haptic 160 may be used to hold the lens body 105 and force translating arm 115 back relative to a tip 162 that may be placed in the sulcus or capsular bag.

[0136] Any of the stabilization systems described herein can be disposed coaxially or coplanarly with the force-translating arm 115, or positioned along a different axis than the force-translating arm 115, such that the stabilization system 120 is offset from or angled relative to the force-translating arm 115 as described above with respect to the haptic 160. Similarly, the stabilization system 120 can be angled relative to the force-translating arm 115 such that at least a portion of the stabilization system 120 is angled away from the plane of the AIOL such that at least a portion of the stabilization system sits on a different plane than another portion of the stabilization system.

[0137] It should be understood that any of the stabilization systems described herein can be formed from silicone rubber elastomers, polyurethane, PMMA, PVDF, PDMS, polyamide, polyimide, polypropylene, polycarbonate, or a hydrophobic or hydrophilic flexible acrylic material, or any combination of these materials. In order to provide the stabilization function of the stabilization system while maintaining flexibility for insertion and manipulation, the stabilization system can have a softer body reinforced with a more rigid structure.

[0138] One or more portions of the stabilization system 120 described herein may incorporate an occlusal element to improve fixation within the eye. In some embodiments, the stabilization system 120 includes a haptic 160, and the occlusal element is positioned near their distal end 162 to improve fixation of the haptic 160 within the eye. The haptic 160 may be any of a variety of haptic designs or combinations of haptic designs, including, but not limited to, open loop, closed loop, plate, plate-ring, single plate, j-ring, c-ring, modified J-ring, multiple pieces, single piece, angled, flat, offset, etc. The haptic 160 contemplated herein may include a Rayner designed haptic (Rayner Intraocular Lenses, LLC, East Sussex, UK), a Nulens designed haptic (Nulens LLC, Israel), a Staar lens design (Staar Surgery, Monrovia, California), and others. In some embodiments, whether the stabilization system 120 includes one or more haptics 160 or includes a 360 degree flange 172, it can be formed of a biocompatible polymer such as silicone rubber, polyurethane, PMMA, PVDF, PDMS, polyamide, polyimide, polypropylene, polycarbonate, PEEK, etc., or a combination of such materials. The stabilization system 120 can be formed of a material or configured to be foldable. In some embodiments, the stabilization system 120 is formed of a shape memory material.

[0139] The AIOL described herein has improved mechanical stability (internally and / or externally) that results in more efficient shape change. The shape change is more efficient because it occurs only at the desired location (i.e., at the shape deforming membrane 140 and the dynamic membrane 143), without causing distortion or bulging elsewhere in the device that would detract from the desired shape change. The efficiency of the shape change is due in part to the mechanical isolation of the moving parts. As will be described in more detail below, one or more internal supports 110 provide sufficient rigidity to the AIOL 100 to mechanically isolate the moving parts to effectively and efficiently implement the shape change without unintentional bulging or distortion in other parts of the device. The inward facing areas of the AIOL 100 described herein can have reduced angles, rounded edges, and fewer blind spots, which improve the efficiency of the shape change achieved.

[0140] FIG. 16A to FIG. 16F as well as FIG. 17A to FIG. 17F An embodiment of an AIOL having an internal support 110 is illustrated. The internal support 110 can be used to mechanically isolate the optical elements (anterior and posterior) from the stresses imparted by the stabilization system 120 to limit optical distortion. Fig.16D and Fig.17D1, the inner support 110 can be a ring-shaped element defining a central slot 113. The slot 113 can have an inner diameter that is sized to receive at least a portion of the stationary lens element 150 therethrough. As described elsewhere herein, the stationary element 150 can have a flat surface 151 on a first side, a curved surface 152 on a second, opposing side, and a peripheral connecting ring 153 having a sealing surface 154. The peripheral sealing surface 154 of the stationary element 150 can abut and seal against a rearwardly facing, generally planar surface that surrounds the slot 113 of the inner support 110. The peripheral connecting ring 153 of the stationary element 150 can be engaged by the inner diameter of the central slot 113. Thus, the stationary element 150 can be retained by the slot 113 of the inner support 110 and the curved surface 152 that is available toward the posterior side of the AIOL 100 by the slot. The perimeter region 144 of the front optic 145 can be positioned above the planar, front-facing surface of the inner support 110 surrounding the gap 113. As can be seen, the planar portion of the inner support 110 surrounding the gap 113 is captured between the perimeter region 144 of the front optic and the sealing surface 154 of the stationary element 150. The inner support 110 can have an outer perimeter that generally matches the outer perimeter of the lens body 105. The annular element 104 of the lens body 105 is coupled to the outer perimeter of the inner support 110 (see Fig. 16B and Fig. 17B ). The outer perimeter of the inner support 110 can be spaced a distance within the peripheral membrane 140, so that when the force conversion arm 115 is moved, the peripheral membrane 140 can be pushed inward a distance to cause the adjustment shape change. Thus, the ring element 104 can be coupled to the front surface of the inner support at a first position, and the ring element 104 can be coupled to the rear surface of the inner support 110 at a second position, so that the peripheral membrane 140 spans the distance between the first position and the second position (see Fig. 16C and Fig. 17C ). The distance between the first position and the second position is defined by wedge-like features 117 near the outer perimeter. The presence of these features 117 limits the movement of the force conversion arm 115 and reduces the risk of tearing during implantation in the eye, such as by injection. The features 117 can have a generally wedge shape, such that the thicker portion of the features 117 is positioned more peripherally facing the peripheral membrane 140 and tapers toward the central gap 113. The outer facing surface of the features 117 can be concave or otherwise angled inwardly to ensure that the peripheral membrane 140 avoids contact with the features 117 during movement of the force conversion arm 115. It should be understood that the features 117 need not be wedge-shaped. For example, Fig.18C and Fig.19E Other embodiments of inner supports are illustrated having features 17 that are more square or rectangular in cross-section such that they do not taper toward the central gap 113 .

[0141] Typically, the material of inner support 110 is sufficiently rigid to mechanically isolate the optic, particularly when AIOL 100 is placed under stresses imparted by stabilizing haptics 160 . FIG. 17A to FIG. 17F An embodiment of an AIOL 100 is illustrated having an internal support 110 that is configured to mechanically isolate the optical portion of the device from stresses imparted by the stabilizing haptics 160. The internal support 110 is configured to prevent optical distortion of the central region even during movement of the stabilizing haptics 160, such that the stabilizing haptics 160 do not impart shape changes to the optical portion of the device, such as the dynamic membrane 143 or the anterior optic 145. The strength of the internal support 110 relative to other portions of the AIOL 100, such as the shape deforming membrane 140 and the dynamic membrane 143, provides improved durability during manipulation and handling of the lens during insertion.

[0142] Regardless of the configuration, the inner support 110 can limit efficiency-impairing lens movement in regions of the AIOL 100 other than the region where accommodative movement is desired. The inner support 110 serves to focus all ciliary-induced pressures toward the central dynamic membrane 143. The inner support 110 mechanically isolates the dynamic region of the AIOL 100 and structurally reinforces the non-dynamic region of the AIOL 100, thereby focusing the shape change only on the desired location for accommodation-side deformable membrane 140 via the force conversion arm 115 and the dynamic membrane 143 caused by the increased pressure within the fluid-filled chamber 155. The geometry and rigidity of the inner support 110 serve to mechanically prevent other lens regions from deforming under the increased internal pressure of the fluid-filled capsule. The inner support 110 can be formed of any of a variety of materials or combinations of materials, which can be opaque or transparent, but the inner support is generally more rigid than the movable portion of the AIOL 100. In some embodiments, the components of the AIOL 100 are formed of the same material, which provides advantages from a manufacturing standpoint. The materials of the various components can be the same (i.e., silicone rubber), but the mechanical properties of the various components can be unique depending on what function the components perform for the AIOL (i.e., shape change or force transmission or centering and stabilization). One component of the AIOL can be more rigid than another component of the AIOL (e.g., the inner support 110 compared to the peripheral membrane 140), but the two components can be of the same material. A more rigid component can be more rigid than a less rigid component due to the geometric structure and size differences of the component. It can be seen that the inner support 110 and the membranes 140, 143 can be formed of the same silicone rubber material, but because the membranes 140, 143 have a significantly reduced thickness compared to the inner support 110, the membranes 140, 143 are easily deformed when a compressive force is applied, while the inner support 110 is not easily deformed. In some embodiments, the inner support 110 can be a silicone rubber elastomer (e.g., silicone rubber PDMS 70-90 Shaw A), and the membranes 140, 143 can be silicone rubber elastomers (e.g., silicone rubber PDMS 20-50 Shaw A). Additionally, the inner support 110 may include a geometry that imparts increased rigidity and stiffness relative to the membranes 140 , 143 .

[0143] The various components and features of the AIOL described herein may be incorporated into any of a variety of combinations. It will be appreciated that the description of a particular feature shown with reference to a particular figure is not intended to be limiting, as the feature may be incorporated into another embodiment of the AIOL described herein. For example, the AIOL described herein may include a stabilization system that incorporates one or more features of the stabilization system described herein. Further, an AIOL having a stabilization system feature may be combined with any of the various features described with reference to, for example, the force conversion arm 115 or the shape deforming membrane 140.

[0144] The AIOLs described herein can achieve optical refractive power or diopters (D) in a desired range (e.g., up to approximately 5 diopters (D) change) due to the shape change of the front lens 145 and the micrometer-range movement of the force conversion arm 115 (e.g., up to approximately 25 μm to 100 μm from each side or from a single side together) when a small amount of force is applied (e.g., as little as 0.1 to 1.0 grams of force (gf)). It can be seen that the AIOLs described herein control small forces and provide mechanical isolation for reliable optical devices so that even asymmetric forces can achieve spherical results in accommodation. The compressible region can be the region of the sealed cavity 155 that undergoes deformation when the deformable membrane 140 is moved to cause the dynamic membrane 143 to flex outward in response. The compressible region may have: a length L, which is the distance the deformable membrane 140 is displaced inward; a height H, which is the cross-sectional height of the deformable membrane 140 along the optical axis of the lens; and an arc length W, which is the cross-sectional length of the shape-deformed membrane 140 perpendicular to the optical axis A of the lens 100. The displacement of the shape-deformed membrane 140 causes a volume compression V related to the product L*H*W. In the case of a lens 100 with two shape-deformed membranes 140 in two force-transmitting arms 115, the volume V of fluid compressed by the ciliary movement of magnitude L will be approximately 2*L*H*W. The actual volume may be slightly less than this idealized calculation due to inefficiencies associated with elastic deformation and complex geometric structures. The volume of the lens bending can be described by the following equation:

[0145]

[0146] The lens height (h) can be calculated from the Pythagoras equation: (rh) 2 +a 2 = r 2 Therefore, h = r-√(r 2 -a 2). As an example, if the refractive index of the optical fluid within the sealed cavity 155 is 1.4 and the diameter of the lens is 3 mm, a 28 μm movement (L) of two relatively deformable membranes 140 having a height (H) of 0.37 mm and an arc length (W) of 3.0 mm produces a sufficient amount of pressure applied by the optical fluid against the front lens 145 to form a 1D lens. If the diameter of the lens is 3 mm, an 84 μm movement of two deformable membranes 140 having a height (H) of 0.37 mm and an arc length (W) of 3.0 mm can produce a sufficient amount of pressure applied by the optical fluid against the dynamic membrane 143 to form a 3D lens. Additional examples are provided below in Tables 1 and 2 below. Table 1 illustrates device parameters, including the change in power in diopters (D), the diameter of the dynamic membrane 143, the curvature of the outward curvature of the dynamic membrane 143, and the volume of the lens curvature or the volume of the optical fluid occupying the space created in the outward curvature of the device filled with an optical fluid of a refractive index (RI) of 1.382. Table 2 illustrates device parameters, including the change in power in diopters (D), the diameter of the dynamic membrane 143, the curvature of the outward curvature of the dynamic membrane 143, and the volume of the lens curvature or the volume of the optical fluid occupying the space created in the outward curvature of the device filled with an optical fluid of a refractive index of 1.43 (RI). The curvature is calculated based on the starting power of 0D. The curvature can be measured directly with a surface profiler or a white light interferometer. The curvature can also be inferred based on the measured change in power and a known refractive index.

[0147] Table 1

[0148]

[0149] Table 2

[0150]

[0151]

[0152] In some embodiments, the device has a dynamic lens diameter of 2.5 mm and is filled with oil having an RI of 1.382. The device can achieve the following accommodations: about 1.4D with about 20 microns of movement when about 0.26 gf is applied, about 2.6D with about 40 microns of movement when about 0.58 gf is applied, about 3.5D with about 60 microns of movement when about 0.85 gf is applied, about 4.7D with about 80 microns of movement when about 1.1 gf is applied, and about 6.3D with about 100 microns of movement when about 1.4 gf is applied.

[0153] The AIOL 100 described herein has an improved shape change efficiency. This improved efficiency allows for a substantially reduced volume of the sealed cavity 155 (and, thereby, the optical fluid 156 that fills the cavity 155) and a thinner maximum cross-sectional dimension (particularly near the peripheral region of the AIOL 100). Even with minimized cross-sectional dimensions at the non-optical peripheral region, the effective power change (e.g., ±3 or ±4 diopters) can be comparable to lenses with larger volumes. In some embodiments, the volume of the cavity 155, and thereby the optical fluid 156, can be less than about 8.5 mm 3 Until less than about 2mm 3 In some embodiments, the volume can be 3 mm 3 Up to about 6mm 3 The small volume can provide sufficient diopter change within the range of ±4 diopters when the membrane 140 is displaced in the micrometer range, which causes the membrane 140 to be displaced within about 0.2 mm. 3 To about 0.3mm 3 The displacement of the optical fluid 156 achieved depends on the desired accommodative range (e.g., 3 or 4D), the diameter of the shape-deformable membrane, and the refractive index of the material within the AIOL. The lens can be designed to achieve this "accommodative state" with the design of the lateral membranes, the limitations of physiological processes, and the maximum efficiency mechanism.

[0154] The AIOL described herein can be implanted according to various surgical methods known in the art. Depending on the features and components of the device, various techniques can be used or various tools can be used to implant the device. The device described herein can be used alone or in combination with another artificial lens or the patient's natural lens. The refractive power of the lens body and the relative position of the force conversion arm and / or stabilization system can be adjusted and / or fine-tuned at any time before, during or after implantation. The device described herein can be implanted so that at least a portion of the device is positioned outside the lens capsule, for example, in front of the capsule and behind the iris. The device described herein can be implanted so that the central portion of the lens body is aligned with the optical axis of the eye. The force conversion arm can be positioned relative to one or more ciliary structures (such as the apex of the ciliary body or ciliary muscle). The force conversion arm can be positioned so that they are close to the ciliary structure (or very closely associated with the ciliary structure when not close to the ciliary structure) when the ciliary structure is in a static unadjusted state without causing compression of the lens body, and the lens body includes a deformable region of the lens body. However, the force conversion arm can be positioned close enough to the ciliary structure so that when the ciliary muscle contracts, the lens body undergoes accommodation, and when the ciliary muscle relaxes, the lens body undergoes loss of accommodation, and the materials of the lens body quickly return to their resting state. The relative position and length of the force conversion arm can be adjusted according to the various methods described above using one or more of the various features described herein for adjustment. The stabilization system can be positioned within the ciliary sulcus, close to the ciliary process, or within a portion of the capsular bag to further stabilize the device within the eye and prevent the device from jumping forward toward the iris, where iris contact is minimized. The resting refractive power of the lens body can also undergo additional adjustment and fine-tuning according to the various methods described herein and using one or more of the various features described herein for refractive power adjustment.

[0155] The size of the parts of the device described here can vary. In some embodiments, the entire visual zone portion of the lens body 105 can have a diameter, and the diameter is about 2.5mm, about 3.0mm, about 3.5mm, about 4.0mm, about 4.5mm, about 5.0mm, about 5.5mm, about 6.0mm, about 6.5mm or a larger diameter. In some embodiments, the adjustable diameter or area of ​​the central visual zone (e.g., dynamic membrane 143) subjected to shape change is 1.0mm to 6.0mm in diameter. In some embodiments, the dynamic membrane 143 is 1.5mm to 3.5mm in diameter. In some embodiments, the dynamic membrane 143 is 1.7mm to 2.5mm in diameter. In some embodiments, the AIOL 100 can be foldable so that the device can be implanted in the eye with an incision smaller than that of an otherwise non-foldable rigid AIOL. For example, a device having a flexible or foldable stabilization system 120 can have a first diameter during implantation that is smaller than a diameter achieved by the device after implantation, which is after deployment or expansion of the stabilization system 120. In some embodiments, the device can include a stent, and the stent can be made of a flexible material so that the stent can bend during implantation of the device. In other embodiments, the device can flex or fold across a portion of the device. As described above, the AIOL can include one or more internal stents 110, and the internal stents 110 can be spaced a distance from each other, which forms a corridor 112 through the sealed cavity 155 between the posts of the stent, which results in a sealed cavity 155 having any one of a variety of shapes (e.g., H-shaped, X-shaped, or other shapes). Figures 3D to 3G Examples of potential fold lines F1F2 along one or more corridors 112 of the AIOL are shown. Other fold lines exist. The AIOL described herein can be folded along one or more of these corridors 112 so that adjacent inner supports 110 fold on top of each other. As described above, the force translation arms 115 can include central regions 116 that are thinner to encourage folding across these central regions 116 (see 18A to 18C). Folding the AIOL described herein or rolling up the flexible AIOL in this manner allows the device to be implanted with smaller incisions, which would otherwise be impossible with respect to an AIOL having rigid components (such as a stent that is not configured to fold). In addition to reducing the overall size of the incision required for implantation, the folding and / or rolling up of the AIOL described herein allows the use of typical insertion tools or minimally invasive implantation tools. The AIOL described herein may also have a narrow cross-sectional thickness that allows insertion into the eye with the aid of a small incision. In some embodiments, the AIOL 100 may have a cross-sectional thickness between the front and rear ends that is approximately 2.5 mm to as thin as approximately 0.5 mm. In some embodiments, the device has a maximum cross-sectional thickness of approximately 1.3 mm. As will be described in more detail below, the device described herein is configured to be implanted with an incision that is less than approximately 4 mm. For example, the device can be inserted through a small incision, such as a clear corneal incision that is no greater than approximately 3.5 mm.

[0156] FIG. 4A to FIG. 4C as well as FIG. 5A to FIG. 5B An embodiment of an AIOL 100 is illustrated that is implanted within an eye such that a posterior portion of the AIOL 100, including at least a portion of the stabilization system 120 and the stationary element 150, is inserted into an anterior region of the capsular bag 22 by means of a capsulorhexis C. The anterior portion of the AIOL 100, including the force translation arm 115 and the anterior lens 145, extends outside of the capsular bag 22. As can be seen, the anterior capsule assists in orienting the AIOL 100 relative to the ciliary body apex. The edge of the capsular bag 22 created by the capsulorhexis C can extend over the anterior face of the stabilization system 120 (regardless of whether the system 120 includes one or more of the stabilization haptics 160, the flange 172, and / or a hoop-like structure that provides 360 degree stabilization). For example, in some embodiments, the edge of the capsular bag 22 can extend over the anterior face of one or more stabilization haptics 160 and abut the annular element 104 of the lens body 105 near where the inner region 161 of the stabilization haptics 160 couples to the annular element 104. Alternatively, the edge of the bladder 22 may extend over the front surface of the flange 172 and slide into the groove 174 between the front surface of the flange 172 and the rear surface of the annular element 104. FIG. 15A to FIG. 15C as well as FIG. 16A to FIG. 16F As shown, the front surface of flange 172 can have a front extending outer protrusion that is configured to engage with the rearward interior surface of the bladder pocket of the front bladder. Fig.12The illustrated stabilization system 120 depicts that the edge of the capsular bag 22 formed by the capsulorhexis C can extend above the flange 172 and below the protective outer edge 1210 of the shield 1205. Regardless of the stabilization mechanism 120, the edge of the capsular bag created by the capsulorhexis C can be tucked under the posterior surface of the force conversion element 115, so that the force conversion element 115 extends outside of the capsular bag 22 and at least a portion of the stabilization system 120 remains inside the capsular bag 22. Implanting the AIOL 100 in this superior-inferior manner provides additional stabilizing support to orient the AIOL 100 about the visual axis of the eye and prevent movement of the AIOL 100 toward the iris 14. In general, the AIOLs described herein can maintain a gap with the iris 14 when implanted that is approximately 0.05 mm to 0.5 mm. The edge of the capsular bag 22 provides a generally posteriorly directed force to the anterior surface of the stabilization system 120 that pulls the AIOL away from the iris 14. This force is balanced by a generally rearwardly directed force due to engagement between the contact portion 135 of the force translating arm 115 and the ciliary structures of the eye.

[0157] It should be understood that the AIOL described herein need not be implanted using a superior-inferior configuration. As described elsewhere herein, the stabilizing haptic 160 can be positioned within the ciliary sulcus, and only the posterior portion of the AIOL is positioned within the capsular bag. Positioning the stabilizing haptic 160 within the ciliary sulcus can provide forward pressure to the AIOL 100 for further stabilization and assist in keeping the peripheral portion of the device away from the iris.

[0158] Still refer to FIG. 5A to FIG. 5B , the maximum cross-sectional thickness T of the AIOL 100 can be approximately 2.5 mm or less, so that the device can be inserted through a clear corneal incision having a length of approximately 3.5 mm. In some embodiments, the maximum cross-sectional thickness T taken along the plane of the optical axis A of the lens is between about 0.5 mm and 1.5 mm thick. In some embodiments, the maximum cross-sectional thickness T of the AIOL taken along the plane of the optical axis A of the lens is approximately 1.3 mm, which can be implanted with a 3.5 mm clear corneal incision.

[0159] In order to achieve accommodation, the AIOL described here relies on direct contact with the ciliary muscle. Thus, at least a portion of the peripheral area of ​​the AIOL must be sized to fit in this narrow space between the capsular bag and the iris. As described elsewhere herein, the AIOL described here has a thin maximum cross-sectional dimension near the peripheral area to provide this direct engagement without adversely affecting the iris. Minimizing the cross-sectional dimension of the peripheral area greatly reduces the internal volume of the AIOL. Alternatively, the inner facing surface of the sealed cavity has a reduced angle to further improve the efficiency of the AIOL. Although the AIOL has a smaller overall cross-sectional dimension and internal volume than an AIOL with a much larger internal volume, the improved efficiency of the components of the AIOL enables them to achieve effective diopter changes (e.g., ±4 diopters). The thickness profile of the non-optical peripheral area (i.e., the area of ​​the AIOL 100 located outside the optical zone of the lens) can be minimized to avoid contact with the iris. FIG. 4A to FIG. 4B An embodiment of an accommodating intraocular lens is illustrated positioned within capsular bag 22, and the relative position of the peripheral region of iris 14 is shown. FIG. 16A to FIG. 16F as well as FIG. 17A to FIG. 17F An embodiment of the AIOL is illustrated that minimizes the maximum cross-sectional dimension near this peripheral region. The thickness of the AIOL 100 near the posterior-upward optical zone (e.g., the curved surface 152 of the posterior stationary element 150) extends into the capsular bag 22 and has little to no effect on the iris 14. Fig.16E and Fig.17E As best shown in FIG. 1 , the maximum cross-sectional thickness T of the peripheral region of the AIOL 100 (ie, excluding the posterior stationary element 150 that bulges posteriorly into the capsular bag) may be between about 500 um and about 700 um. Fig.16F and Fig.17F As best shown in FIG. 1 , the maximum cross-sectional thickness T of the peripheral region of the AIOL 100 (ie, excluding the posterior stationary element 150 that bulges posteriorly into the capsular bag) may be between about 700 um and about 950 um.

[0160] The AIOL can be folded or rolled into an applicator with a 2.5 mm tip, but it should be understood that other applicators are contemplated herein. However, generally, large scleral incisions should be avoided, and the AIOL described herein can be implanted with a scleral tunnel or scleral incision approximately 6 mm to 7 mm long.

[0161] In some embodiments, as described above, AIOL is implanted in an up-down manner. As described above, the up-down manner of implantation stabilizes the position of the lens and limits iris contact. Up-down implantation also prevents the unintentional rotation of AIOL 100 around the optical axis A of the device. The rotation of AIOL 100 around the optical axis A may cause the horizontally oriented force conversion arm 100 to move toward a vertical orientation, which is more prone to displacement from the ciliary structure, and the displacement may damage the adjustable mechanism of AIOL. As an example, AIOL 100 may include two relative force conversion arms 115, and may be implanted so that the contact portion 135 of each force conversion arm 115 is in static contact or easily contacts one of the two when the ciliary muscle 18 (e.g., ciliary body vertex) contracts, to drive the shape change of the optical device during accommodation and loss of accommodation. As mentioned above, AIOL can (but does not need to) be oversized, such as 0.05mm to 0.5mm. Oversizing can be used to ensure contact between the ciliary structure and the force conversion arm. However, in certain circumstances, due to displacement and sedimentation of the lens or postoperative changes in ciliary body diameter, oversizing may not be enough to ensure contact. For example, the AIOL may be oriented so that a gap of approximately 0.05 mm may exist between the ciliary structure and the contact portion 135 of the force conversion element 115 on the first side, and another 0.05 mm gap exists between the contact portion 135 of the force conversion element 115 on the second side and the ciliary structure. At optimal centering, the gap remains substantially equal on each side. If the AIOL is implanted so that the force conversion element 115 is vertically oriented relative to the eye (and relative to each other), the AIOL 100 may settle or shift downward due to gravity, so that the gap on the superior side or head side increases to approximately 0.1 mm, and the gap on the inferior side or tail side decreases toward 0 and remains in static contact with the ciliary structure. Implanting the AIOL 100 so that the relative force conversion arms 115 are oriented horizontally (medial-laterally) relative to the eye (and relative to each other) minimizes displacement of the AIOL 100 and maintains optimal spacing between the force conversion arms 115 and the ciliary structures during use. Implanting the stabilizing haptic 160 inside the capsular bag 22 and implanting the force conversion arms 115 outside the capsular bag 22 limits rotation of the AIOL 100 about the optical axis A and avoids de-centering of the device, which may render the accommodative mechanism of the lens inoperable. The orientation of the AIOL in the eye combined with an oversizing of approximately 0.05 mm to 0.5 mm can enhance qualitative and ensure contact with the eye structure. It should be understood that oversizing is not necessary for proper placement and fit of the AIOL described herein. For example, the patient's ciliary diameter at the plane of the AIOL can be accurately imaged and measured to avoid the need for oversizing to overcome problems associated with fit.

[0162] The AIOL described herein can be implanted by twisting or rotating into position so that the horizontally oriented force translating arms 115 are wedged into engagement with the ciliary muscles. This allows for adjustment of fit during implantation. Fig. 6A 1 is a front view of an eye showing a capsulorhexis. Although not shown in this figure, the ciliary muscle 18 naturally has a generally oval shape when viewed from the front. The AIOL 100 can be inserted through the anterior chamber, through the iris, and into the posterior chamber with the aid of a small corneal incision. Once inside the posterior chamber, the AIOL 10 can be unfolded and / or unrolled. The AIOL can be oriented so that the posterior surface of the device is positioned inside (behind) the capsulorhexis and the force conversion arm 115 remains outside (in front) the capsulorhexis. The AIOL can be rotated about the optical axis AXU of the device relative to the ciliary muscle until each force conversion arm 115 is wedged into a suitable position against the ciliary structure (e.g., the ciliary sulcus or the ciliary body vertex). The force conversion arms 115 are wedged into a suitable position so that they are generally positioned in a horizontal or medial-lateral orientation relative to the eye. The force conversion arms 115 can be rotated to wedge into contact with the ciliary muscle 18, or can be rotated to maintain a small gap between the contact portion 135 and the eye tissue. The gap can be, for example, a 0.1 mm gap. Once the force translating arm 115 is oriented generally horizontally relative to the eye, the edge of the capsular bag 22 formed by the capsulorhexis C extends over the anterior surface of the stabilizing haptic 160. Securing the haptic 120 in the capsular bag 22 in this manner pulls the anterior surface of the AIOL 100 away from the iris 14. The narrow cross-sectional thickness T of the AIOL also provides a larger clearance relative to the iris 14. In embodiments where the stabilizing haptic 120 is designed to fit within the sulcus, the posterior region 107 or rearmost surface of the AIOL can be positioned within the edge of the capsular bag 22, and the stabilizing haptic 160 positioned anteriorly within the sulcus, thereby compressing the AIOL 100 in a posterior direction.

[0163] The capsulorrhexis C may be oval in shape and may optionally incorporate one or more slits S extending radially outward from the edge of the capsulorrhexis C and away from the optical axis A of the eye (see Fig. 6A ). The oval capsulorhexis C and optional slit S allow the AIOL 100 to sink further into the capsular bag 22 and be positioned more posteriorly by removing or minimizing interference between the anterior capsule and the posterior surface of the AIOL. This allows the force translation arm 115 to more easily approach and wedge the ciliary body apex 18. The anterior capsule can limit the movement of the AIOL while allowing the AIOL to be positioned in a more posterior position. In some embodiments, the oval capsulorhexis C can be 6 mm x 7 mm.

[0164] Typically, rotational implantation of the AIOL can allow for optimal positioning between the contact portion 135 of the force conversion arm 115 and the ciliary structure. Rotational implantation can avoid the need to adjust the length of the force conversion arm 115. However, it should be understood that after implantation in the eye, the AIOL can be further adjusted to improve fit and / or optical refractive power. For example, the length of the force conversion arm 115 can be adjusted, as can the angle at which the force conversion arm 115 extends away from the lens body 105. In order to change the basic refractive power of the lens body 105, one or more portions of the device can be expanded or contracted in situ. In some embodiments, the expansion and / or contraction of the lens body 105 can be mechanically performed, such as by inserting a screw or another mechanical feature against the lens body 105 to cause a change in the shape of the lens body 105. In some embodiments, the expansion and / or contraction of the lens body 105 can be performed by injecting and / or withdrawing an optical fluid 156 from a sealed cavity 155 of the lens body 105. The amount of optical fluid 156 can be varied by injecting and / or withdrawing the optical fluid 156 within the sealed cavity 155 via an external port having a one-way valve configured to receive a custom syringe needle or pumping mechanism. The tension on the front lens 145 (or stationary element 150) can also be adjusted by applying energy to the material. For example, the material can be a heat sensitive material that can generate bubbles when thermally activated. The change in tension and volume on the lens body 105 can depend on whether bubbles are formed, depressions, or flattening occurs when the material is activated. The stationary lens can also be modified in this way.

[0165] like Figure 8 As shown, the patient can be evaluated preoperatively by measuring the diameter of the patient's ciliary body (box 805). The diameter of the ciliary body can be measured by ultrasound biomicroscopy (UBM), optical coherence tomography (OCT), or other medical imaging techniques. The patient's optical power requirements can be measured preoperatively (box 810). These measurements can be used to select a lens 100 with the optimal force translation arm 115 size and optical power (box 815). Fig. 9As shown, after preoperative measurement of ciliary body diameter (box 905) and selection of a lens of appropriate size and optical power for the patient (box 910), the lens 100 can be implanted and positioned after cataract removal surgery (box 915). An intraoperative assessment of engagement between the contact portion 135 of the force conversion arm 115 and the target ciliary structure can be performed (box 920). In some embodiments, adjustment of the force conversion arm 115 can be performed (box 925), and further intraoperative assessment of engagement can be performed (arrow 926). As described elsewhere herein, the force conversion arm 115 can be adjusted in situ for size. An intraoperative assessment of the optical engagement of the lens can be performed until the desired engagement is achieved (box 930). In some embodiments, the optical power can be adjusted (box 935). As described elsewhere herein, the optical power of the lens can be adjusted in situ to produce a more spherical or cylindrical lens. After accommodation, further intraoperative assessment of the optical fit of the lens may be performed until the desired refractive power is achieved (arrow 936). The operation may then continue as per standard surgical procedure (block 940). Fig.10 Illustrated with Fig. 9 Embodiments of postoperative lens adjustment similar to the described method. After the preoperative measurement of ciliary body diameter (block 1005) and the selection of a lens with the appropriate size and optical power for the patient (block 1010), the lens 100 can be implanted and positioned after cataract removal surgery (block 1015). The operation can continue according to standard surgical operations (block 1020). A postoperative assessment of the engagement between the contact portion 135 of the force conversion arm 115 and the target ciliary structure can be performed (block 1025). In some embodiments, the adjustment of the force conversion arm 115 can be performed (block 1030), and a further postoperative assessment of the engagement can be performed (arrow 1036). A postoperative assessment of the optical engagement of the lens can be performed until the desired engagement is achieved (block 1035). In some embodiments, the optical power of the lens can be adjusted in situ (block 1040). After adjustment, further postoperative assessment of the optical fit of the lens may be performed until the desired power is achieved (arrow 1046). It should be understood that the assessment and adjustment of lens fit and power (whether performed intraoperatively or postoperatively) may be completely independent of each other to the extent that either may be performed without the other. In certain circumstances, lens power may be assessed and adjusted without assessing lens fit. In other circumstances, lens fit may be assessed and adjusted without assessing lens power.

[0166] The position of the AIOL can be assessed intraoperatively and postoperatively using imaging techniques known in the art. One or more components of the AIOL may be formed of materials such as silicone rubber that are not transparent and visible during evaluation using imaging techniques such as UBM. Therefore, the AIOL may incorporate one or more visual markers 1100 to assist in assessing the position of the lens. The marker 1100 may be made of a material that is visible under one or more imaging processes. In some embodiments, the marker 1100 may be formed of polyimide and may be located on or in one or more regions of the lens 100. The material of the visual marker 1100 may be visually different under imaging compared to one or more components of the rest of the lens formed of another material such as silicone rubber, for example. The marker 1100 may be integrated into an internal bone structure, such as a structure described as reinforcing the lens body 105, the force transmission arm 115, the static element 150, or the stabilization system 120. Alternatively, the marker 1100 may not contribute to the function of the lens, but may be an additional component specifically added to enhance visualization. Alternatively, the marker 1100 can be a geometric modification to any of the lens components that can be easily identified using intraocular imaging techniques known in the art. For example, a divot or through hole can be placed in a silicone rubber structure with an otherwise continuous surface. Such a marker 1100 can guide the physician in making measurements of the lens 100 to ensure a proper fit. The highly visible markers 1100 can be strategically placed in different areas of the lens in a manner that illuminates the location of each structure relative to other lens components and naturally occurring anatomical structures. The marker 1100 can also be used to visualize dynamic movement within the lens. For example, two markers can be positioned so that their relative positions depend on the accommodation state of the lens. Thus, diagnostic imaging of the marker can be used to show the transition of the lens from an accommodation state to a loss of accommodation state.

[0167] Visual markers 1100 can assist the operator in visualizing the correct plane of the AIOL and capturing an image of the force-translating arm 115 along its longest axis. Visual markers 1100 can assist in the capture and analysis of images to clearly identify the distance of the force-translating arm 115 and its vertical position relative to the ciliary process. Visual markers 1100 can also assist in analyzing the movement of the force-translating arm 115 during accommodation after implantation. FIG. 11A to FIG. 11L An embodiment of a lens 100 is illustrated that incorporates one or more visual markers 1100 positioned in various points of the lens 100. The visual markers 1100 may have any of a variety of shapes and sizes to provide additional information regarding the orientation and location of various components of the lens relative to the anatomy of the eye. FIG. 11A to FIG. 11BIllustrated are a top plan view and a side elevation view, respectively, of an embodiment of a lens 100 having a plurality of visual indicia 1100. In this embodiment, the lens 100 may include a first visual indicia 1100a proximate the outer contact region 135 of the force translating arm 115 and a second visual indicia 1100b proximate the inner contact portion 137 of the force translating arm 115. A third visual indicia 1100c may be located at another location of the lens, such as on a portion of the stabilization system 120, such as on the flange 172 or another portion of the lens, such as a ring of the posterior element 150. FIG. 11C to FIG. 11D A top plan view and a side elevation view of another embodiment of a lens 100 having a plurality of visual markers 1100 are illustrated, respectively. The lens 100 may include three sets of visual markers 1100a, 1100b, 1100c. Each of the visual markers 1100a, 1100b, 1100c may have a variable width or thickness such that they provide a differentiated cross-sectional view or pattern under imaging depending on where the cross section is taken. For example, a visual marker 1100a positioned near the outer contact area 135 of the force conversion arm 115 may have a narrow portion 1105 and a wider portion 1110. Similarly, a second visual marker 1100b positioned near the inner contact portion 137 of the force conversion arm 115 may have a narrow portion 1105 and a wider portion 1110. A third visual marker 1100c positioned along the flange 172 of the stabilization system 120 may also have a narrow portion 1105 and a wider portion 1110. When the lens is imaged in cross section, these narrow and wide portions provide short and long patterns, respectively. For example, when taken along line FF Fig.11E The cross-sectional image of the plurality of visual markers 1100a, 1100b, 1100c provides a "long-short-short" pattern on a first side and a "short-short-long" pattern on an opposite side (see Fig.11F ). However, if we intercept along line HH Fig.11G The cross-sectional image of the multiple visual marks 1100a, 1100b, 1100c, the pattern provided by the marks becomes "short-long-short" and "long-short-short" (see Fig.11H ). Similarly, if we intercept along line JJ Fig.11I If the cross-sectional images of the multiple visual marks 1100a, 1100b, 1100c are taken along the line LL, the provided pattern becomes "short-short-long" and "long-short-short". Figure 11K If a cross-sectional image of the plurality of visual marks 1100a, 1100b, 1100c is provided, the provided pattern becomes “short-long-short” and “short-long-short”, and so on.

[0168] Suitable materials or combinations of materials for preparing the various components of the devices disclosed herein are provided throughout. It should be understood that other suitable materials are considered. U.S. Patent Publication Nos. 2009 / 0234449, 2009 / 0292355, and 2012 / 0253459 provide additional examples of other materials suitable for forming specific components for the devices described herein, and each publication is incorporated herein by reference in its entirety. Because one or more components of the lens body 105 are formed of the same material, they can be integrated with each other. For example, the internal support 110 can be a thickened area of ​​the peripheral area 144 of the front lens 145. Similarly, the shape-deformed membrane 140 and the annular element 104 can be integrated with each other having specific physical properties (such as thickness or flexibility) to provide the desired function. Alternatively, one or more of the components of the lens body 105 can be coupled together by techniques known in the art. It can be seen that one or more components of the lens body 105 can be formed of the same material or different materials. One or more of the support 110, the perimeter region 144, the dynamic membrane 145, and the shape-deforming membrane 140 can be formed of an optically transparent, low modulus elastomer such as silicone rubber, urethane, flexible acrylic, or a flexible inelastic film such as polyethylene, and a halogenated elastomer such as a fluorosilicone elastomer. The biocompatible optical fluid can be an incompressible liquid or gel that is clear and transparent in the visible spectrum, for example, silicone rubber fluids and gels, functionalized silicone rubber fluids and gels (e.g., halogens, i.e., fluorinated silicone rubber, aromatics, i.e., phenyl functionalized silicone rubber, etc.), hydrocarbons and functionalized hydrocarbons such as long chain hydrocarbons, halogenated hydrocarbons such as fluorinated and partially fluorinated hydrocarbons, aqueous systems (both fluids and gels) whose refractive index (RI) is increased by adding water-soluble or water-swellable polymers, biopolymer swellable additives such as cellulose, and organic or inorganic additives that form nanostructures that increase the refractive index. In some embodiments, the optical fluid within the sealed cavity 155 has a refractive index greater than 1.37. In other embodiments, the optical fluid within the sealed cavity 155 has a refractive index between 1.37 and 1.57. In other embodiments, the optical fluid within the sealed cavity 155 has a refractive index between 1.37 and 1.60. In a first embodiment, the optical fluid filling the sealed cavity 155 is fluorosilicone rubber oil, and the components forming the sealed cavity 155 (e.g., the shape-deforming membrane 140, the stationary element 150, the inner support 110, the peripheral area 144 of the front lens 145, and the inner facing surface of the dynamic membrane 143) are formed of a silicone rubber elastomer. In a second embodiment, the optical fluid filling the sealed cavity 155 is fluorosilicone rubber oil, and the components forming the sealed cavity 155 are formed of a fluorosilicone rubber elastomer.In a third embodiment, the optical fluid filling the sealing cavity 155 is an aromatic or phenyl substituted oil, such as phenyl silicone rubber oil, and the components forming the sealing cavity 155 are formed of a halogenated silicone rubber elastomer, such as a fluorosilicone rubber elastomer. The combination of materials is selected to optimize the stability of the lens, prevent expansion and maintain an optimal refractive index. In some embodiments, the force conversion arm 115 can be a rigid polymer, such as silicone rubber, polyurethane, PMMA, PVDF, PDMS, polyamide, polyimide, polypropylene, polycarbonate, etc., or a combination thereof. In some embodiments, the force conversion arm 115 can be an element reinforced with PMMA. In some embodiments, the AIOL is formed of all silicone rubber materials, including the rear stationary element 150 and the force conversion arm 115. The stabilization system 120 can be formed of a more rigid silicone rubber, or can be formed of or incorporated into a polyimide. For example, the stabilizing haptic 160 and the flange 172 can be polyimide.

[0169] In various embodiments, description is made with reference to the accompanying drawings. However, a particular embodiment may be practiced without one or more of these specific details or in combination with other known methods and configurations. In the description, a large number of specific details, such as specific configurations, sizes, and processes, are described in order to provide a thorough understanding of the embodiments. In other cases, in order not to make the description unnecessarily vague, known processes and manufacturing techniques are not particularly described in detail. References throughout this specification to "one embodiment", "an embodiment", "an embodiment", "an embodiment", etc. mean that the specific features, structures, configurations, or characteristics described are included in at least one embodiment or embodiment. Thus, the phrases "one embodiment", "an embodiment", "an embodiment", "an embodiment", etc., appearing in various places throughout this specification do not necessarily refer to the same embodiment or embodiment. In addition, specific features, structures, configurations, or characteristics may be combined in one or more embodiments in any suitable manner.

[0170] Device and system described here can be incorporated into any one of various features.An element or feature of an embodiment of device and system described here can be alternatively or in combination with the element and feature of another embodiment of device and system described here and various implants and features described in U.S. Patent Gazette No. 2009 / 0234449, 2009 / 0292355, 2012 / 0253459 and PCT Patent Gazette No. WO 2015 / 148673 to be incorporated, and each publication is incorporated in full by reference herein. For the sake of brevity, the clear description of each of these combinations can be omitted, but various combinations are considered here. In addition, device and system described here can be positioned in the eye, and do not need to be specifically implanted as shown in the figure or as described here. 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 at any time before implantation, during implantation and after implantation. Some representative descriptions of how various devices may be implanted and positioned are provided, however, explicit descriptions of each method for each implant or system may be omitted for the sake of brevity.

[0171] The use of relative terms throughout the description may indicate a relative position or direction or orientation, and is not intended to be limiting. For example, "distal end" may indicate a first direction away from a reference point. Similarly, "proximal end" may indicate a position in a second direction opposite to the first direction. The use of the terms "front," "side," and "rear," as well as "front," "rear," "tail," "head," and the like, is used to establish a relative reference frame, and is not intended to limit the use or orientation of any one of the devices described in the various embodiments herein.

[0172] Although the specification includes many details, these details should not be interpreted as limitations on the scope of claiming or claiming, but should be interpreted as descriptions of features specific to a particular embodiment. The specific features described in the specification under the background of a separate embodiment can also be implemented in combination in a single embodiment. On the contrary, the various features described under the background of a single embodiment can also be implemented individually in multiple embodiments or in any suitable sub-combination. Moreover, although the features can be described above as working in a specific combination and even initially claiming protection as such, one or more features from the claimed combination can be cut out from the combination in some cases, and the claimed combination can be dedicated to a variant of a sub-combination or a sub-combination. Similarly, although operations are depicted in the drawings in a particular order, this should not be understood as requiring such operations to be performed or all illustrated operations in the particular order shown or in a sequential order in order to achieve the desired result. Only some examples and embodiments are disclosed. Changes, modifications and enhancements of the examples and embodiments and other embodiments can be performed based on the disclosed content.

[0173] In the above description and claims, phrases such as "at least one of" or "one or more of" may appear, followed by a connected list of elements or features. The term "and / or" may also appear in a list of two or more elements or features. Unless otherwise implicitly or explicitly denied by the context in which the phrase is used, such phrases are intended to mean any one of the listed elements or features, either independently or in combination with any one of the other listed elements or features. For example, the phrases "at least one of A and B", "one or more of A and B", and "A and / or B" are each intended to mean "A alone, B alone, or A and B together". Similar explanations are also intended to be used for lists including three or more items. For example, the phrases "at least one of A, B, and C", "one or more of A, B, and C", and "A, B, and / or C" are each intended to mean "A alone, B alone, C alone, A and B together, A and C together, B and C together, or A and B and C together".

[0174] Use of the term "based on" above and in the claims is intended to mean "based, at least in part, on" such that unrecited features or elements are also permissible.

Claims

1. An adjustable intraocular lens device for treating an eye, the device comprising: A lens body, the lens body comprising: a first membrane including a first peripheral region and a central conditioning surface configured to flex outwardly; a shape-deformable membrane including an arc length, the shape-deformable membrane configured to undergo displacement relative to the first perimeter region of the first membrane; a stationary lens element having a second peripheral region, the stationary lens element being positioned opposite the first film; an annular inner support sealed on a first side with the first peripheral region of the first membrane and on a second side with the second peripheral region of the stationary lens element; and Fixed volume of optical fluid, wherein the inner surface of the first membrane, the inner surface of the shape-deforming membrane, and the inner surface of the stationary lens element together form a sealed cavity of the lens body containing the fixed volume of optical fluid; a stabilization system comprising an annular structure coupled to the annular inner support and flanges extending radially outward from a posterior region of the lens body, wherein each flange has an outer protuberance that curves in an anterior direction to engage an inner surface of an anterior portion of a capsular bag when the lens device is implanted in an eye; and A force translating arm having a first end and a free end, wherein the first end is operatively coupled to the shape-deforming membrane of the lens body, and the free end is configured to extend out of the capsular bag so as to directly contact the ciliary structure of the eye when the lens device is implanted in the eye, wherein the force translating arm is movable relative to the lens body to cause inward displacement of the shape-deforming membrane.

2. The device according to claim 1, wherein: The force conversion arm includes a first force conversion arm and a second force conversion arm positioned opposite the first force conversion arm, and wherein the flange is positioned between the first force conversion arm and the second force conversion arm.

3. The device according to claim 1, wherein: The stabilization system further includes a groove formed between the posterior facing surface of the lens body and the anterior facing surface of the flange, wherein the groove is sized to receive an edge of a capsular bag formed by a capsulorhexis in the capsular bag.

4. The device according to claim 1, wherein: Each of the flanges further includes a blocker configured to provide a path for fluid to flow out of the bladder.

5. The device according to claim 1, wherein: A front portion of the bladder extends forward of the flange and rearward of the force translating arm.

6. The device according to claim 1, wherein: The annular structure of the stabilization system projects at the rear and has a height of between 50 μm and 700 μm.

7. The device according to claim 6, wherein: The annular structure provides a 360 degree contact point between the device and the posterior surface of the capsular bag to prevent opacification of the posterior capsule.

8. The device according to claim 1, wherein: The inward movement of the shape-deforming membrane compresses the sealed cavity.

9. The device according to claim 1, wherein: The shape-deforming membrane moves a distance between 50 μm and 100 μm.

10. The device according to claim 9, wherein: The distance of movement is such that the refractive power of the lens body changes by at least ±3 diopters.

11. The device according to claim 1, wherein: The central conditioning surface of the first film is a region of reduced thickness that readily gives way upon increasing internal pressure within the sealed cavity or upon pressure applied by the optical fluid to the inner surface of the first film.

12. The device according to claim 1, wherein: The sealing cavity is formed by an optically transparent silicone rubber elastomer.

13. The device according to claim 12, wherein: The optical fluid is incompressible and compresses the inner surface of the first film to induce outward bending of the first film as the shape-deformed film moves inward.

14. The device according to claim 1, wherein: The optical fluid comprises an incompressible liquid having high transparency and high transmission in the visible spectrum.

15. The device according to claim 1, wherein: The optical fluid comprises an incompressible gel having high transparency and high transmission in the visible spectrum.

16. The device according to claim 1, wherein The optical fluid is selected from the group consisting of fluorinated silicone rubber, aromatic silicone rubber, and hydrocarbon.

17. The device according to claim 16, wherein: The hydrocarbons include functionalized hydrocarbons and long-chain hydrocarbons, and the functionalized hydrocarbons include halogenated hydrocarbons.

18. The device according to claim 16, wherein: The aromatic silicone rubber includes phenyl functionalized silicone rubber.

19. The device of claim 1 further comprising an internal support configured to mechanically isolate the optical components of the lens body from deformation during movement of the force conversion arm relative to the lens body and from deformation due to stress on the stabilization system.

20. The device according to claim 1, wherein The first film comprises a variable thickness film.

21. A system comprising the device of claim 1 and a second intraocular lens, the second intraocular lens being a non-accommodating lens.

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