Apparatus and method for supporting and positioning an intraocular lens within the eye

Abstract

An implantable device for supporting an artificial intraocular lens in an eye having an anterior portion of a lens capsule, an iris, and a sclera. The device includes a posterior platform having an anterior-facing surface and an inner wall at least partially defining a central opening. When the device is implanted in the eye, light passes through the intraocular lens and the central opening of the posterior platform toward the retina. The device includes at least one awning positioned on the anterior-facing surface of the posterior platform that forms at least one recess in the anterior portion of the posterior platform. The device is configured to be deployed within the posterior segment of the iris such that no portion of the device rests in contact with the sclera after implantation. Related tools, systems, and methods are provided.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of priority to U.S. Provisional Application No. 63 / 063,110, filed August 7, 2020, U.S. Provisional Application No. 63 / 089,241, filed October 8, 2020, U.S. Provisional Application No. 63 / 129,448, filed December 22, 2020, and U.S. Provisional Application No. 63 / 183,488, filed May 3, 2021. The entire contents of each of these applications are incorporated herein by reference in their entireties.

[0002] This application also relates to U.S. Patent Application No. 16 / 988,519, filed August 7, 2020, which claims the benefit of priority to U.S. Provisional Application No. 63 / 017,423, filed April 29, 2020, and U.S. Provisional Application No. 63 / 053,450, filed July 17, 2020. The entire contents of each of these applications are incorporated herein by reference in their entireties. Technical Field

[0003] The present disclosure relates generally to the field of ophthalmology, and more specifically, to an ophthalmic device for supporting and positioning an intraocular lens within the eye. Background Art

[0004] Implantation of an intraocular lens (IOL) requires intraocular support to hold the IOL in the correct position. Typically, this is achieved by the native capsular bag, a thin thread-like structure suspended by the ciliary zonules. However, lens support may be iatrogenically damaged during surgery (either anterior or posterior segment eye surgery) or from other ocular procedures such as intravitreal injection. Commonly, the posterior capsule is affected, thereby preventing reliable placement of the IOL within the capsular bag.

[0005] To overcome the lack of posterior capsule support due to posterior capsule rupture, surgeons often position the IOL over the anterior capsule with the tactile portion of the IOL facing the ciliary sulcus. However, this can lead to many complications because commercially available IOLs are not optimized for this position. Specifically, neither the dimensions nor the surface contour are ideal for placement between the anterior capsule and the iris. As a result, the optical element or tactile portion of the IOL can cause abrasions to the iris or ciliary body, leading to troublesome complications including uveitis, glaucoma, and anterior chamber hemorrhage (UGH) syndrome. This is particularly problematic with one-piece IOLs, so in this scenario, three-piece IOLs are usually used. However, three-piece IOLs with optical elements that have angular edges, while commonly used, can also cause iris laxity, inflammation, pigment emission, and glaucoma. Furthermore, most annular, multifocal, trifocal, and depth-of-extension focusing lenses are only available in one-piece form. Consequently, these techniques cannot be safely implanted in patients after posterior capsule rupture.

[0006] Unless special procedures (e.g., optical capture) are performed, IOLs placed in the groove become eccentric, reducing visual acuity and photopsia, often requiring further surgery. This problem can worsen if the eccentric IOL encroaches on the iris, ciliary body, or retina, which carries the risk of permanent vision loss.

[0007] The management of secondary IOL placement in the absence of posterior capsule support continues to evolve. Currently, the only FDA-approved solution is the placement of anterior chamber IOLs (ACIOLs). ACIOLs are larger lenses that can be positioned in front of the iris, but over time, these lenses can cause UGH syndrome as well as endothelial cell loss and corneal decompensation, making them contraindicated in many patients. Off-label techniques such as iris suture IOLs can be used, but these are technically difficult and can result in iris pigment loss that leads to glaucoma. Finally, scleral suture IOLs with pancreatic islets are technically complex, carry a risk of rotation, have limited suture durability, and can lead to suture breakage and lens subluxation. Furthermore, all of these techniques force surgeons to use alternative lens types instead of the lens preferred by the patient. Lastly, lens calculations are often insufficient between the initial vitrectomy / phakectomy, and because of the desire to avoid further surgery, suboptimal lenses are frequently implanted, making timing crucial. [Overview of the project]

[0008] In one embodiment, an implantable device is provided for supporting an artificial intraocular lens in an eye having the anterior portion of the lens capsule, the iris, and the sclera. The device includes a posterior platform having a front-facing surface and an inner wall that at least partially defines a central opening. Once the device is implanted in the eye, light passes through the intraocular lens and the central opening of the posterior platform toward the retina. The device includes at least one awning located on the front-facing surface of the posterior platform, forming at least one recess in front of the posterior platform. The device is configured to unfold within the posterior portion of the iris such that no part of the device comes into contact with the sclera after implantation.

[0009] At least one awning positioned on the forward-facing surface of the rear platform can define a front opening. At least one awning may include a visualization feature projecting inward from at least one awning to narrow the dimensions of the front opening. During use, the visualization feature may be directly visualized through the pupil of the eye. The device may have an elongated shape with a long axis and a short axis. The dimensions of the narrowed front opening may be the distance between the centralmost edges of the front opening along the long axis of the device. The distance may be at least about 5.0 mm to about 7.0 mm. The distance may be greater than the diameter of the central opening. During use, at least a portion of the intraocular lens may be positioned in contact with the forward-facing surface within at least one recess. The outer surface of at least one awning may have a smooth shape to protect the iris from the intraocular lens when the device is implanted. At least one inner surface of the awning can provide counter-pressure to the haptic portion of the intraocular lens when positioning the intraocular lens on a forward-facing surface.

[0010] The device may further include one or more stabilizing features. One or more stabilizing features may include a posterior stabilizing feature that extends posteriorly from the posterior surface of the posterior platform and is configured to engage with at least a portion of the lens capsule. The posterior stabilizing feature may include a first portion projecting posteriorly from the posterior surface of the posterior platform and a second portion projecting laterally outward from the first portion. One or more stabilizing features may include a plurality of radially extending structures coupled to the device. Each of the plurality of radially extending structures may include a radially outermost portion for sutureless positioning of the device within the eye. The radially outermost portion may be configured to provide non-penetrating contact with the ciliary tissue of the eye, preventing rotation around the visual axis and assisting in centering the device relative to the eye. The posterior platform may include a substantially non-circular outer circumference and a substantially circular inner circumference. The outer circumference may be substantially rectangular and may have a pair of elongated sides and a pair of short sides. The plurality of radially extending structures may include four radially extending structures. Each of the four radially extending structures can extend radially outward from the point where its long side intersects with its short side. The rear platform can be located in a plane, and the radially outermost points of the multiple radially extending structures are located within the plane of the rear platform. The rear platform can be located in a plane, and the radially outermost points of the multiple radially extending structures are located in front of the plane of the platform. At least one awning can project forward of the radially outermost point.

[0011] The anterior portion of the lens capsule can support the device along the Z-axis of the eye. The posterior platform may further include one or more notches around the central opening. The posterior platform may be formed to be dimensioned to support the central optical element of the intraocular lens on the anterior-facing surface of the posterior platform, and the one or more notches may be formed to receive at least a portion of the tactile portion of the intraocular lens when the intraocular lens is embedded in at least one recess of the device. The device may further include one or more stabilizing features configured to engage with at least a portion of the lens capsule. One or more stabilizing features may extend posterior to at least one recess. One or more stabilizing features may extend anterior to at least one recess.

[0012] In related embodiments, a system is provided comprising an implantable device for supporting an artificial intraocular lens within the eye and the artificial intraocular lens itself. The intraocular lens may be a one-piece or multi-piece intraocular lens. The one-piece intraocular lens may be monofocal, annular, multifocal, extended depth of focus, or receptacle-type intraocular lens.

[0013] In related embodiments, a method is provided for implanting a device for supporting an artificial intraocular lens in the eye. The method includes the steps of inserting a posterior device into the posterior chamber of the eye and positioning a one-piece intraocular lens relative to a posterior platform such that at least a portion of the intraocular lens is positioned below at least one awning and at least a portion of the intraocular lens abuts a front-facing surface. The tactile portion of the intraocular lens can be positioned below at least one awning. The step of inserting the device into the posterior chamber of the eye may include inserting the device without transscleral fixation.

[0014] In related embodiments, a method is provided for supporting an artificial intraocular lens (IOL) in an eye, comprising the step of preparing a lens support device for insertion into the eye. The lens support device includes a posterior platform having a front-facing surface and a rear-facing surface; a central opening extending through the posterior platform, through which light passes towards the retina when the lens support device is implanted in the eye; at least one awning projecting over at least a portion of the front-facing surface of the posterior platform, the at least one awning having an inner surface and an outer surface, the awning forming at least one recess between the inner surface of the awning and the front-facing surface of the posterior platform; and a plurality of radially extending structures coupled to the device and projecting radially outward from the device, the radially extending structures having a radially outermost portion for sutureless positioning within the posterior chamber for positioning the lens support device in the eye. The method includes the steps of positioning a lens support device behind the iris of the eye such that no part of the device comes into contact with the sclera of the eye and the surface facing the rear of the rear platform is positioned in front of the anterior part of the lens capsule of the eye; positioning the radially outermost part of a radially extending structure adjacent to a groove to position the central opening behind the pupil of the eye; positioning the optical portion of the IOL in front of at least a portion of the surface facing the front of the rear platform across the central opening; and positioning at least a portion of the tactile portion of the IOL in at least one recessed portion to attach the IOL to the lens support device.

[0015] In related embodiments, a method is provided for implanting an artificial intraocular lens (IOL) into an eye, comprising the steps of creating an opening in the anterior wall of the lens capsule of the eye and preparing a lens support device for insertion into the eye. The lens support device includes a main body having a central opening and a lens support structure. The lens support structure includes a substantially flat lens support surface at least partially surrounding the central opening and at least one recess anterior to the lens support surface. Once the device is implanted in the eye, light passes through the central opening toward the retina. The method further includes a plurality of radially extending structures coupled to the main body. Each of the plurality of radially extending structures includes a radially outermost portion for sutureless positioning of the device within the posterior chamber of the eye and a plurality of stabilizing features extending posteriorly from the posterior surface of the lens support structure. The method further includes inserting the lens support device behind the eye and the iris of the eye, and after insertion, ensuring that no part of the device rests in contact with the sclera of the eye. The method further includes the steps of: positioning the radial outermost part of each of a plurality of structures adjacent to the groove of the posterior chamber in order to stably position the central opening behind the pupil of the eye; inserting each of the plurality of stabilizing features through an opening in the anterior wall of the lens capsule to assist in fixing the device to the lens capsule; inserting the IOL into the eye; positioning the optical portion of the IOL in front of at least a portion of a substantially flat lens support surface over the central opening; and attaching the IOL to the lens support device by positioning at least a portion of the tactile portion of the IOL in at least one recess of the lens support structure.

[0016] In related embodiments, a method is provided for implanting an artificial intraocular lens (IOL) in an eye, comprising the steps of creating an opening in the anterior wall of the lens capsule of the eye and preparing a lens support device for insertion into the eye. The lens support device includes a main body having a central opening, and when the lens support device is implanted in the eye, light passes through the central opening toward the retina. The main body further includes a lens support surface at least partially surrounding the central opening, and at least one recess in front of the lens support surface, and further comprises at least one stabilizing feature extending posteriorly from the posterior surface of the lens support structure. The method includes the steps of: inserting a lens support device behind the eye and iris of the eye so that no part of the device rests in contact with the sclera of the eye after insertion; inserting at least one stabilizing feature through an opening in the anterior wall of the lens capsule to fix the lens support device to the lens capsule and position the central opening behind the pupil of the eye; inserting an IOL into the eye; positioning the optical portion of the IOL in front of at least a portion of the lens support surface across the central opening; and positioning at least a portion of the tactile portion of the IOL in at least one recess to fix the IOL to the lens support device.

[0017] The lens support device may further include a plurality of radially extending structures coupled to the main body. Each of the plurality of radially extending structures may include a radially outermost part for sutureless positioning of the device within the eye. The method may further include the step of positioning the radially outermost part of each of the plurality of radially extending structures adjacent to the sulcus of the eye in order to prevent rotation around the visual axis and to assist in centering the device relative to the eye.

[0018] In some modifications, one or more of the following can be optionally included in any viable combination of the above compositions, methods, apparatus, and systems. Further details of the compositions, methods, apparatus, and systems are described in the accompanying drawings and the following description. Other features and advantages will become apparent from the description and drawings. [Brief explanation of the drawing]

[0019] These and other aspects will be described in detail below with reference to the accompanying drawings. Generally speaking, the drawings are not drawn to scale, either absolutely or relatively, but are intended to be illustrative. In addition, the relative arrangement of features and elements may be modified for illustrative clarity.

[0020] [Figure 1A] Figure 1A is a perspective view of an embodiment of the device. [Figure 1B] Figure 1B shows the device of Figure 1A with an intraocular lens (IOL) deployed therein. [Figure 1C] Figure 1C is a top view of the device of Figure 1B. [Figure 1D] Figure 1D is a top view of the device of Figure 1B. [Figure 1E] Figure 1E is a further view of the device of Figures 1A to 1B. [Figure 1F] Figure 1F is a further view of the device of Figures 1A to 1B. [Figure 2A] Figure 2A is a cross-sectional view of the device of Figure 1B deployed in an eye to support an IOL. [Figure 2B] Figure 2B is a top view of an eye implanted in the same manner as Figure 2A. [Figure 3] Figure 3 shows another embodiment of the device. [Figure 4A] Figure 4A is a side view of an embodiment of the device. [Figure 4B] Figure 4B is a perspective view of an embodiment of the device. [Figure 5A] Figure 5A is a top view of another embodiment of the device. [Figure 5B] Figure 5B is another view of the device of Figure 5A. [Figure 5C] Figure 5C is another view of the device of Figure 5A. [Figure 6A] Figure 6A is a top view of an embodiment of a device incorporating a plurality of radially extending bumpers and posterior stabilizing features. [Figure 6B] Figure 6B is a perspective view of an embodiment of a device incorporating a plurality of radially extending bumpers and posterior stabilizing features. [Figure 6C] Figure 6C is a cross-sectional view of an embodiment of a device incorporating a plurality of radially extending bumpers and posterior stabilizing features. [Figure 6D] This is a perspective view of the device shown in Figure 6A, which is located inside the eye and visualized through the pupil. [Figure 6E] This is a cross-sectional view of the device shown in Figure 6A, which is implanted in the eye. [Figure 7] A partial top view of an embodiment of a device having an anti-rotation fixing arm or tether is shown. [Figure 8A] This is a perspective view of the interrelated embodiments of the device. [Figure 8B] This is a perspective view of the interrelated embodiments of the device. [Figure 8C] This is a perspective view of the interrelated embodiments of the device. [Figure 8D] This is a bottom view of the device in Figure 8A that supports the intraocular lens. [Figure 8E] This is a top view of the device shown in Figure 8A that supports the intraocular lens. [Figure 8F] This is a side view of the interrelated embodiments of the device. [Figure 9A] This is a top view of interrelated embodiments of the device. [Figure 9B] This is a bottom view of the interrelated embodiments of the device. [Figure 10A] These are interrelated embodiments of a device having a front stabilization feature. [Figure 10B] This shows a cross-sectional view of the device implanted in the eye, as shown in Figure 10A. [Figure 10C] These are interrelated embodiments of a device having a front stabilization feature. [Figure 10D] Figure 10C shows a cross-sectional view of the device implanted in the eye. [Figure 11A] This illustrates related embodiments of a device having an awning configured to accommodate an IOL. [Figure 11B] This illustrates related embodiments of a device having an awning configured to accommodate an IOL. [Figure 11C] This illustrates related embodiments of a device having an awning configured to accommodate an IOL. [Figure 11D]This illustrates related embodiments of a device having an awning configured to accommodate an IOL. [Figure 11E] This illustrates related embodiments of a device having an awning configured to accommodate an IOL. [Figure 11F] This illustrates related embodiments of a device having an awning configured to accommodate an IOL. [Figure 12A] This illustrates related embodiments of a device having an awning configured to accommodate an IOL. [Figure 12B] This illustrates related embodiments of a device having an awning configured to accommodate an IOL. [Figure 12C] This illustrates related embodiments of a device having an awning configured to accommodate an IOL. [Figure 13A] This illustrates related embodiments of a device having an awning configured to accommodate an IOL. [Figure 13B] This illustrates related embodiments of a device having an awning configured to accommodate an IOL. [Figure 13C] This illustrates related embodiments of a device having an awning configured to accommodate an IOL. [Figure 13D] This illustrates related embodiments of a device having an awning configured to accommodate an IOL. [Figure 13E] This illustrates related embodiments of a device having an awning configured to accommodate an IOL. [Figure 14] The image shows a top view of an eye with an embedded device having a biased arm visible through the pupil. [Figure 15] The image shows a top view of an interrelated embodiment of a device having multiple radially extending bumpers and multiple transscleral fixation arms. [Figure 16A] This is an end view of the fixed footplate that is connected to the end of the fixed arm. [Figure 16B] Figure 16A is a side view of the fixed arm. [Figure 16C] This is an end view of the fixed footplate that is connected to the end of the fixed arm. [Figure 17] This is a side view showing a straight forward fixing arm designed to bias the device forward to prevent rearward drift during the externalization of the fixing footplate. [Figure 18A] This shows interrelated embodiments of a device incorporating multiple transscleral fixation arms. [Figure 18B] The image shows a top view of an interrelated embodiment of a device incorporating multiple transscleral fixation arms and a posterior stabilization feature. [Figure 18C] This shows a perspective view of an interrelated embodiment of a device incorporating multiple transscleral fixation arms and a posterior stabilization feature. [Figure 18D] A perspective view shows an interrelated embodiment of a device incorporating multiple transscleral fixation arms, multiple radially extending bumpers, and a rear stabilization feature. [Figure 18E] This shows a top view of an interrelated embodiment of a device incorporating multiple transscleral fixation arms. [Figure 18F] Figure 18E shows a cross-sectional view of the apparatus along line FF. [Figure 18G] Figure 18E shows a cross-sectional view of the apparatus along line GG. [Figure 18H] Figure 18G shows the device implanted in the eye. [Figure 18I] This is a top view of an interrelated embodiment of a device incorporating multiple transscleral fixation arms. [Figure 18J] This is a perspective view of an interrelated embodiment of a device incorporating multiple transscleral fixation arms. [Figure 19A] Plan views of interrelated embodiments of the device are shown. [Figure 19B] Plan views of interrelated embodiments of the device are shown. [Figure 20A] This shows a plan view of the interconnected devices incorporating reinforcing materials. [Figure 20B] This shows a plan view of the interconnected devices incorporating reinforcing materials. [Figure 20C]This shows a plan view of the interconnected devices incorporating reinforcing materials. [Figure 20D] This shows a plan view of the interconnected devices incorporating reinforcing materials.

[0021] It should be understood that the drawings in this specification are for illustrative purposes only and are not intended to be to scale. [Modes for carrying out the invention]

[0022] This disclosure relates to the field of ophthalmology in general, and more particularly to ophthalmic devices including artificial support structures that can be used to support an intraocular lens (IOL) or other ophthalmic implant when “intracapsular” implantation is undesirable.

[0023] The most common treatment for aphakia caused by cataract lens removal is the placement of an IOL within the natural lens capsule. The lens capsule forms a lumen with anterior and posterior components and is supported by the ciliary zonules, thus providing a stable structure for IOL support. A typical IOL includes an optical element and one or more tactile parts that support the optical element within the eye. The design of the IOL largely determines where the IOL can be implanted in the eye. One-piece IOLs, such as multifocal, annular, and enclosed IOLs, may be preferred by both surgeons and patients. These premium lenses are typically not suitable for implantation in the sulcus due to the sharp shape of their tactile edge and the larger anterior-posterior tactile thickness which can cause iris damage. However, in some cases, implantation within the lens capsule is undesirable, for example, due to tears or loss of the anterior or posterior capsule or ciliary zonules.

[0024] The apparatus described herein can be implanted in the posterior chamber of the eye and fixed above the anterior capsule to stably hold all forms of IOLs (one-piece or multi-piece IOLs) having various tactile and optical forms to provide reliable refractive results. The apparatus described herein can incorporate features specifically designed to accommodate annular IOLs by maintaining the orientation of the IOL. The apparatus also allows for posterior segment placement, which significantly reduces the risk of damage to the iris, anterior chamber angle, or cornea. Implantation posterior to the iris and cornea eliminates or reduces the risk of corneal damage, iris hemorrhage, and glaucoma. The apparatus described herein reduces the risk of complications compared to current techniques such as ACIOLs, iris suture lenses, or scleral suture lenses, or compared to commercially available IOL placement in the ciliary sulcus. The apparatus described herein provides surgeons and patients with a full range of IOL options.

[0025] Figures 1A to 1D show embodiments of a lens support device 2100 for supporting and positioning an IOL 110 within the eye. Figure 1A is a perspective view of the device 2100 before the IOL 110 is placed. Figures 1B to 1D show the device 2100 after the IOL 110 has been positioned with the device 2100. Figure 2A shows a cross-sectional view of an eye model and the device 2100 deployed to support the IOL 110. Figure 2B shows the eye as seen through the iris 10, which is shown as transparent. Figure 2B also shows the cornea 5, ciliary body 15, sclera 20, ciliary sulcus 25, and pupil 30, defined centrally through the iris 10. The device 2100 is configured to be positioned between the anterior portion 35 of the capsule and the iris 10 in the posterior chamber, covering a capsulotomy 40. The capsulotomy 40 is an opening formed in the anterior wall of the lens capsule. The anterior portion 35 of the lens capsule is preferably intact, but in some embodiments of the device 2100, the anterior portion 35 of the lens capsule may be partially torn. The device 2100 may include a posterior lens support structure or platform 2105 for positioning relative to the anterior portion 35 of the lens capsule, one or more awnings 2110 projecting over a portion of the platform 2105, and one or more stabilizing features such as a plurality of radially extending structures or bumpers 2114 that are coupled to the main body of the device and configured to provide non-penetrating contact with ocular tissue. The posterior platform 2105 can support the IOL 110 and prevent it from falling into the posterior chamber during implantation. The anterior portion 35 of the lens capsule can provide Z-axis support to the posterior platform 2105. Together with the platform 2105, one or more awnings 2110 form a main body that helps position and secure the IOL 110 relative to the platform 2105 while protecting surrounding ocular tissue, such as the iris, from damaging contact with the IOL 110. Even portions of the IOL 110 not covered by the awning 2110 can be effectively shielded because they are recessed relative to the foremost surface of the device 2100 (i.e., the front-facing surface of the awning 2110). One or more bumpers 2114 are positioned near the periphery of the platform 2105 and project outward from the device 2100 to non-traumatically contact the ciliary ocular tissue, such as the ciliary body 15 or ciliary sulcus 25, thereby providing the center of the device 2100.Furthermore, one or more bumpers 2114 can provide an anti-rotation function in the Z-plane and / or prevent displacement in the Z-plane in order to maintain proper alignment between the central plane of the device and the visual axis of the eye. In some embodiments, one or more stabilizing features can be positioned relative to the device and engaged with at least a portion of the lens capsule, such as the anterior capsule, to stabilize and center and fix the device relative to the eye (see stabilizing features 2138 in Figures 5A, 8A-8F, 9A-9B, and 10A-10D). The stabilizing features 2138 can engage with a capsulotomy in the anterior part of the capsule. The device can be configured to position the IOL 110 anterior to the lateral capsulotomy of the lens capsule or posterior to the lateral capsulotomy of the lens capsule. Each of these embodiments is described in more detail below.

[0026] An IOL 110 typically includes a central optical element 112 and two tactile portions 114 coupled to the optical element 112. The apparatus 2100 can accommodate IOLs 110 having any of the various conventional forms, including multi-piece IOLs, one-piece IOLs, and plate configurations. Similarly, the tactile portions 114 of the IOL 110 can be any of the various configurations. The tactile portions 114 can be conventional open-loop tactile portions such as C-loops, J-loops, modified J-loops, or other tactile portions. A one-piece IOL can have open-loop tactile portions similar to those of a conventional three-piece IOL. A one-piece IOL may also incorporate monoblock plate-style tactile portions. It should be understood that if the apparatus 2100 is shown with a certain type of IOL (e.g., a multi-piece IOL or a one-piece IOL), other types of IOLs can be mated with the apparatus.

[0027] Referring again to Figure 1A, the posterior lens support structure or platform 2105 of the device 2100 may have a forward-facing lens support surface directed toward the anterior part of the eye when the platform 2105 is in use, and a posterior-facing lens support surface directed toward the posterior part of the eye relative to the lens capsule when the platform 2105 is in use. The posterior platform 2105 can provide several functions. The posterior platform 2105 may have surfaces (a forward-facing surface or a posterior-facing surface) that form a stable platform on which the IOL 110 can be positioned during use. The posterior platform 2105 can substitute for the lens capsule and set the effective lens position of the IOL 110 within the eye. The geometric and mechanical functions of the posterior platform 2105 may not only support the IOL 110 during use, but may also help in centering the IOL 110 in the case of an asymmetric eye or asymmetric surgical procedure. The posterior platform 2105 provides an artificial anterior capsule support for the IOL and a stable intraocular platform structure that replicates the innate anterior capsule. The rear platform 2105 may be substantially flat or planar between the front-facing surface and the rear-facing surface. The thickness of the rear platform 2105 between the front-facing surface and the rear-facing surface can be minimized while still providing sufficient support for the IOL. The thickness can be about 0.02 mm to 1.5 mm, or about 0.5 mm to 1.0 mm. The rear platform 2105 may be about 0.2 mm thick. The thickness of the rear platform 2105 can be less than 0.2 mm, and still provide sufficient support for the IOL. For example, the rear platform 2105 can be reinforced with a more rigid material to strengthen it and limit its deformation despite its thickness of only 0.2 mm. Alternatively, the rear platform 2105 can have an increased thickness (e.g., from about 0.50 mm to about 1.0 mm), and a material thickness sufficient to limit the deformation of the device even when placed under tension and / or compression. By increasing the rigidity of the lens support structure, the insertion of the IOL after implantation can be facilitated.This allows for further increases in the hoop strength of the opening 2115 extending through the posterior-probability platform 2105, as will be described in more detail below, thereby limiting the risk of the IOL accidentally passing through the opening 2115 during implantation of the IOL within the apparatus 2100. Reinforcements of the apparatus described herein to avoid strain and the risk of the IOL passing through the apparatus will be described in more detail below.

[0028] As shown in Figures 1A to 1D, the rear platform 2105 may include an outer region 2111 that defines the overall shape of the rear platform 2105, and an inner wall 2109 that defines a central aperture or aperture 2115 that extends through the entire thickness of the rear platform 2105 from the front-facing surface to the rear-facing surface. The central aperture 2115 is configured to be substantially coaxial with the optical axis of the IOL when positioned on the rear platform 2105 of the device 2100. When the device is implanted in the eye, light passes through the central aperture 2115 and through the optical axis of the IOL towards the retina. The device firmly fixes the IOL 110 in a coaxial position. The central aperture 2115 can give the rear platform 2105 a substantially ring shape. However, the rear platform 2105 does not need to be circular on both its inner and outer surfaces. For example, the inner wall 2109 of the rear platform 2105 may be substantially circular or have a circumference that forms a uniform substantially circular shape. The outer region 2111 of the rear platform 2105 may be circular, but does not have to be. The outer region 2111 of the rear platform 2105 may have any of the following non-circular shapes, including a rounded rectangle as shown in Figures 1A to 1D, or an ellipse, ellipse, rounded triangle, or other geometric shapes or freeform surfaces. In some embodiments, the non-circular shape of the outer region 2111 includes a plurality of lobes projecting outward from a plurality of sides. The plurality of lobes may project radially away from the central opening 2115. The plurality of sides may be substantially flat or concave. Thus, the rear platform 2105 may have a width between the outer region 2111 and the inner wall 2109 that varies around the outer circumference. The shape of the outer region 2111 of the posterior platform 2105 and its interaction with the intraocular device 2100 will be described in more detail below. The non-circular shape of the outer surface can be a rounded rectangle having a pair of short sides 2107 and a pair of long sides 2108.

[0029] The IOL 110 may be positioned above the central aperture 2115 relative to the posterior platform 2105 such that its central axis CA, which extends anteriorly through the central aperture 2115, extends through the optical element 112 of the IOL 110 (see Figure 1B). Light can pass through the aperture 2115 and the IOL 110 positioned on the posterior platform 2105. When the IOL is positioned relative to the posterior platform 2105, the central aperture 2115 may be substantially coaxial with the optical axis of the IOL 110. The central aperture 2115 has a diameter such that the IOL 110 does not fall into the posterior chamber and the optical element 112 of the IOL is supported on the anterior-facing surface of the posterior platform 2105. The diameter of the central aperture 2115 avoids the posterior platform 2105 substantially overlapping with the optical element 112 of the IOL 110, thereby allowing light to pass through the device without optical obstruction as it passes toward the retina. The diameter of the aperture 2115 is designed to be generally universal for a wide range of IOL types. Conventional IOLs typically have an optical element with an outer diameter of 6 mm, but this size can vary depending on the IOL. Central apertures 2115 with a diameter of less than 5.0 mm to about 4.0 mm, preferably about 4.75 mm, can be used with some IOLs. Central apertures 2115 with a diameter of 5.0 mm to about 6.0 mm can be used with most IOLs, so that the device is nearly universal for use with any conventional tactile stabilization IOL. The minimum inner diameter of the aperture 2115 can be greater than about 4.0 mm, greater than about 4.5 mm, greater than about 5.0 mm, greater than about 5.5 mm, greater than about 6.0 mm, greater than about 6.5 mm, up to about 7.0 mm, up to about 8.0 mm, up to about 9.0 mm, up to about 10 mm, up to about 15 mm, and any range in between. The inner diameter of the central aperture 2115 may be between approximately 4 mm and 8 mm, or between approximately 4 mm and 6 mm. The inner diameter of the central aperture 2115 can approach the outer diameter of a typical IOL optical element 112, for example, at least approximately 5.5 mm or 6.0 mm.

[0030] The opening diameter can be selected to maintain a specific hoop strength and limit the risk of the IOL accidentally passing through the opening 2115 during implantation. Smaller opening diameters can increase hoop strength compared to larger opening diameters. A stiffer IOL housing limits the deformation of the opening 2115 when placed under tension and / or compression. Increased rigidity of the IOL housing can also facilitate easier insertion of the IOL after intraocular fixation.

[0031] The central opening 2115 does not need to be smaller than the IOL diameter. If the central opening 2115 has an inner diameter larger than the outer diameter of the IOL optical element 112, the rear platform 2105 can incorporate one or more feature portions extending into the central opening 2115 to effectively reduce the inner diameter of the central opening 2115, so that the platform 2105 can support the IOL optical element and prevent the IOL 110 from falling through the central opening 2115. The device 2100 may include a plurality of leaflets configured to support the optical element of the IOL. The leaflets can project inward relative to the inner wall 2109 of the platform 2105 so as to extend into the opening of the central opening 2115. The leaflets can support the optical element on their forward-facing surfaces, or they can be deflected so that the optical element passes through and is supported by a rear-facing surface of the leaflet. The tactile portion 114 of the IOL 110 can remain on the front-facing surface of the platform 2105, and the optical element 112 of the IOL 110 can be positioned on the rear-facing surface of the valve leaflet, thereby maintaining the Z position of the IOL 110. The valve leaflet may be full-thickness or partial-thickness. That is, the valve leaflet may be the same thickness as the platform 2105, or it may be thinner than the platform 2105. The valve leaflet may rise from the front-facing surface of the platform 2105. The valve leaflet may also rise from the rear-facing surface of the platform 2105. If it originates from the rear-facing surface, the optical element 112 of the IOL 110 can be positioned in a recess formed by the central opening 2115 and the front-facing surface of the valve leaflet. The device 2100 may include one, two, three, or more valve leaflets. Each valve leaflet may be arranged symmetrically around the platform 2105. The valve leaflets may have an inner diameter narrower than the inner diameter of the central opening 2115. The narrower inner diameter of the valve leaflets may be approximately 4.0 mm to 6.0 mm, or approximately 5.0 mm to 5.5 mm, or approximately 5.0 mm. Each valve leaflet may have a thickness of approximately 0.10 mm to 0.50 mm, or approximately 0.15 mm to approximately 0.35 mm, or approximately 0.25 mm.

[0032] The central aperture 2115 can be the sole aperture extending through the rear platform 2105, such that the platform 2105 has a single optical aperture extending through its entire thickness. In some embodiments, the rear platform 2105 incorporates a full-thickness aperture in addition to the central aperture 2115. These additional apertures can form a discontinuous rear surface to the device, which can reduce the overall bulk of the device 2100 while still providing sufficient surface area to support the IOL 110. In some embodiments, the discontinuous rear surface can include one or more notches 2144 through the rear platform 2105 (see Figures 8A-8E). In other embodiments, the device 2100 does not have a rear support 2105, but instead relies on the anterior part of the lens capsule to support the central optical element 112 along the Z-plane (see Figures 9A-9B). Each of these will be described in more detail below. In further embodiments, the rear platform 2105 (whether having a discontinuous or continuous surface) does not have a central opening 2115 defined by the inner circumference 2109. A solid rear platform 2105 can help prevent vitreous loss. In some embodiments, the solid rear platform 2105 can be a planar optical surface configured to allow light to pass through. In other embodiments, the rear platform 2105 has refractive or light-filtering optical properties.

[0033] In some embodiments, the rearward-facing surface of the rear platform 2105 is configured to seat on the anterior pouch 35 (see Figure 2A). The rearward-facing surface of the rear platform 2105 may include one or more feature areas or may be textured to increase friction and prevent accidental movement of the device relative to the anterior pouch 35 after embedding. Increased friction may help minimize lateral and / or rotational movement of the device 2100 relative to the anterior pouch 35.

[0034] The IOL 110 is shown positioned against the anterior-facing surface of the posterior platform 2105, as shown in Figure 1B. Depending on the circumstances, a limited space may exist between the front of the device 2100 and the posterior surface of the iris 10. To reduce the risk of iris damage or pupillary block, the IOL 110 can be fixed on or behind the plane of the posterior platform 2105. The posterior platform 2105 can be configured to allow the surgeon to use an “optical capture” technique for implanting the IOL 110 into the device 2100. In this technique, the optical element 112 of the IOL 110 is passed behind the posterior platform 2105, partially or completely through the central opening 2115, while the tactile portion 114 of the IOL 110 may remain substantially anterior to the posterior platform 2105. This technique ensures that the IOL 110 is not able to drift in the X, Y, or Z axes after surgery and reduces the bulk of the space anterior to the lens. This technology further enables the safe use of "square-edge" IOL morphs by reducing IOL contact with the posterior surface of the iris 10. It adds flexibility for surgeons to change IOL power by selecting the effective lens position. This technology also allows the use of astigmatism-corrected (annular) IOLs by limiting IOL rotation. Furthermore, preoperative lens selection calculations become more accurate by fixing the optical element while increasing the predictability of its refractive position.

[0035] To facilitate the use of optical capture techniques, the aperture 2115 may have a diameter similar to that of a typical IOL optical diameter, for example, 5.5 mm or 6.0 mm. In this scenario, the surgeon can guide the IOL 110 through the aperture 2115 by applying a force parallel to the optical axis, or by slightly tilting the IOL 110 to facilitate its passage through the aperture 2115. Alternatively, the device 2100 may incorporate a feature that allows the diameter of the aperture 2115 to be temporarily enlarged to allow the IOL 110 to pass through the aperture 2115. As previously mentioned, the platform 2105 may include an inner wall 2109 defining the central aperture 2115. The inner wall 2109 may be discontinuous such that the platform 2105 forms a split-ring with a gap between the ends of the ring. In this embodiment, the inner diameter of the aperture 2115 may vary depending on whether the ends of the ring are aligned toward each other or spread apart. In another embodiment, the inner wall 2109 defining the central opening 2115 may be discontinuous. The device 2100 may have one or more slits in the inner wall 2109 arranged circumferentially around the opening 2115. The slits may preferably have a length radially outward from the inner wall 2109 (e.g., 0.25 mm–2.0 mm) thereby increasing the flexibility of the platform 2105 and expanding the effective diameter of the central opening 2115 to allow the optical element 112 to pass through the flexible lens platform 2105. Alternatively, the device 2100 may incorporate one or more deflectable flaps molded into the platform 2105. The device 2100 may include a plurality of deflectable flaps, e.g., 2 to 40 flaps, which deflect the IOL 110 to pass through the opening 2115 when sufficient force is applied by the surgeon. Alternatively, the inner wall 2109 may have a brush-like structure that deflects the IOL 110 to pass through under sufficient force applied by the surgeon. In yet another embodiment, the cross-sectional thickness profile of the platform 2105 may be tapered toward the opening 2115.The outer region 2111 of platform 2105 may have a greater thickness (e.g., thickness measured anterior-posterior when the device is placed in the eye) than the thickness of the inner circumference of platform 2105 near the inner wall 2109. Thus, the central portion of platform 2105 (i.e., the inner wall 2109) may have greater flexibility due to a reduction in thickness that allows the inner wall 2109 to deflect when the IOL 110 passes through the opening 2115 and is placed under sufficient force. Despite the greater flexibility near the inner wall 2109, whether due to a slit, flap, or reduction in thickness, platform 2105 has sufficient strength to support the IOL 110 resting on the front of platform 2105 or an IOL partially or completely behind platform 2105.

[0036] Referring again to Figures 1A and 1B, the outer region 2111 of the rear platform 2105 can be coupled to one or more side walls 2112 projecting forward from the outer region 2111. The side walls 2112 can curve onto the forward-facing surface of the rear platform 2105 to form one or more awnings 2110. The awnings 2110 combined with the side walls 2112 can form a main body that defines one or more recesses 2104 in front of the forward-facing lens support surface. At least a portion of the IOL 110 can be placed within one or more recesses 2104 of the main body. As previously stated, the device 2100 can be inserted into the posterior eye of the iris so that no part of the device is placed in contact with the sclera of the eye after insertion. The radial outermost part of each of the multiple radially extending structures can be positioned adjacent to the groove of the posterior chamber to stably position the central opening 2115 behind the pupil of the eye. Next, the IOL 110 can be inserted into the eye and positioned such that the optical element 112 of the IOL 110 is on the central opening 2115 of the rear platform 2105 and in front of at least a portion of the lens support surface of the platform 2105. The peripheral region of the rearward-facing surface of the optical element 112 may be positioned relative to the frontward-facing surface of the rear platform 2105. Each of the tactile portions 114 of the IOL 110 may be substantially or at least partially positioned within the respective recesses 2104 on either side of the central opening 2115, with the majority of the optical element 112 of the IOL 110 remaining outside the recesses 2104 and exposed through the front opening 2127 (see Figure 1B) of the device 2100 to secure the IOL 110 to the device 2100.

[0037] The elongated anterior opening 2127 can be defined by the space between the awning 2110 and / or the lateral wall 2112. While the anterior opening 2127 may be large enough to allow easy passage and implantation of all IOL types (one-piece, three-piece, plate, etc.), it can still capture at least a portion of the tactile portion 114 of the IOL 110 under the awning 2110 in the recess 2104, thereby holding the IOL 110 behind the awning 2110. The lateral wall 2112 can project forward by a sufficient distance from the front-facing surface of the rear platform 2105, providing height to the recess 2104 and allowing the tactile portion 114 to easily pass under the awning 2110 into the recess 2104. This is particularly useful to allow the surgeon to implant a one-piece IOL preferred by the patient. One-piece intraocular lenses can include monofocal, annular, multifocal, extended depth of focus, and the intraocular lens to be housed. However, the size of the recess 2104 and the thickness of the device 2100 are minimized to mitigate contact between the device and the back of the iris when positioning the device relative to the anterior pouch. For example, the device 2100 can have a thickness ranging from approximately 0.3 mm to approximately 2.0 mm from the front-facing surface of the awning 2110 to the rear-facing surface of the platform 2105. This front-to-rear thickness of the device is minimized to avoid interaction or contact between the awning 2110 and the iris, and the smooth outer shape and rounded edges of the awning 2110 and sidewalls 2112 prevent iris trauma in the event of contact. The height of the recess 2104 between the front-facing surface of the rear platform 2105 and the inward-facing surface of the awning 2110 can be at least approximately 0.65 mm, at least approximately 0.70 mm, at least approximately 0.75 mm, and a maximum of approximately 1.00 mm. The height of the recess 2104 provides space for operating the IOL relative to the device. In some embodiments, the rear platform 2105 has a thickness of about 0.20 mm and a recess height of about 0.65 mm. In some embodiments, the rear platform 2105 has a thickness of about 0.50 mm and a recess height of about 0.75 mm.Therefore, despite the thicker rear platform 2105, the height of the recess 2104 can be increased.

[0038] The awning 2110 can be sized and shaped to cover potentially traumatic surfaces of the IOL 110 when the IOL 110 is placed on the device 2100. For example, the tactile portion 114 of the IOL 110 or the junction 115 between the tactile portion 114 of the IOL 110 and the optical element 112, particularly those designed to be completely embedded inside the lens capsule, can be formed of material or have a traumatic surface shape to eye tissue. For example, sharp or square edges of an IOL can cause damage to delicate eye tissue such as the iris. The awning 2110 of the device 2100 is designed to cover at least these surfaces of the IOL 110 to protect the iris from contact with them.

[0039] In further embodiments, the awning 2110 may be sized and shaped such that it has at least a portion that protrudes more centrally than another awning to allow forward visualization of the device through the pupil. The pupil diameter during surgery can be unpredictable and may change during IOL implantation. The centrally protruding visualization feature 2117 of the awning 2110 can be designed to directly visualize the device 2100 through the pupil while avoiding interference with the optical elements of the implanted IOL. The central protruding feature narrows the inner diameter of the front opening 2127, for example, the inner diameter along the long axis of the device. The awnings 2110 on either side of the device 2100 can specify a distance between their central edges from at least about 7.0 mm to about 5.0 mm, preferably about 6.0 mm. Direct visualization of the device 2100 during IOL implantation increases the likelihood that the IOL will be properly secured within the device. The front visualization feature section of the device will be described in more detail below in relation to Figures 18E to 18J.

[0040] In some embodiments, the device 2100 has a single side wall 2112 extending around the periphery of the platform 2105, forming a single awning 2110 extending 360 degrees around the central opening 2115, thereby at least partially covering the edges of the optical elements 112 and the tactile portion 114 of the IOL 110. In other embodiments, the device 2100 has multiple awnings 2110 coupled to the platform 2105 by multiple side walls 2112. For example, as shown in Figures 1A to 1B, the device 2100 may have a first awning 2110 projecting onto the forward-facing surface of the first short side 2107 of the platform 2105, and a second awning 2110 projecting onto the forward-facing surface of the opposite short side 2107 of the platform 2105. Each awning 2110 may have an arc length around the central opening 2115 such that the combined surface area of ​​the awning 2110 and the side walls 2112 is less than 360 degrees around the central opening 2115. Each awning 2110 may cover only a portion of each tactile portion 114 of the IOL, leaving the edges of the optical elements 112 exposed. Preferably, the awning 2110 does not overhang the optical portion 112 of the IOL 110 such that the elongated front opening 2127 is much larger than the diameter of the optical portion 112. This is in contrast to the smaller central opening 2115 of the rear platform 2105, which approaches the diameter of the central optical portion 112 of the IOL 110. The front opening 2127 is generally significantly larger than the central opening 2115. Even if the awning 2110 can incorporate one or more visualization features 2117, the front opening 2127 defined by the awning 2110 can be larger than the central opening 2115 (see Figures 1E, 3, 15, 18A, 18I, etc.).

[0041] The embodiments shown in Figures 1A to 1D have a single side wall 2112 that extends around the entire circumference of the platform 2105 at the positions of both awnings 2110 along both long sides 2108 and both short sides 2107. In this embodiment, the opposing awnings 2110 can be fully connected to each other along the long sides 2108 and form a complete enclosure around the rear platform 2105 defining the front opening 2127. However, the side wall 2112 does not need to extend around the entire circumference of the platform 2105. A first side wall 2112 can project forward from the short side 2107 of the platform 2105 and connect to the awning 2110, and a second side wall 2112 can project forward from the opposite short side 2107 of the platform 2105 and connect to its respective awning 2110. In this embodiment, the front opening 2127 of the space between the awnings 2110 is not bounded on all sides by a wall forming a continuous opening 2127. Nevertheless, an opening 2127 exists for inserting the IOL 110 into the recess 2104.

[0042] The elongated side 2108 may be relatively straight or curved. In some embodiments, the elongated side 2108 can incorporate a recess 2113 that curves inward near the center of the elongated side 2108 (see Figures 19A-19B). The recess 2113 can be positioned between the bumper 2114 positions. The recess 2113 may have an inward radius of curvature that reflects the radius of curvature of the outer bumper, giving each elongated side 2108 an overall S-shaped curve when viewed from above. The recess 2113 in the side wall 2112 on the elongated side 2108 gives the chassis an hourglass shape.

[0043] In some embodiments, the distance of the awning 2110 projecting from the rear platform 2105 is asymmetrical. For example, a first awning 2110 or a first portion of the awning 2110 may project a first distance from each side wall 2112. A second awning 2110 or a second portion of the awning 2110 may project a second distance from its side wall 2112, which is different from the first distance. This asymmetry can allow for easier insertion of the leading or trailing tactile section 114 of the IOL 110. The leading tactile section 114 can be inserted first under the larger awning 2110, and the trailing tactile section 114 can then be inserted under the smaller awning 2110. The front opening 2127 defined by the awning 2110 (and optionally the side walls 2112) may also be asymmetrical, allowing for specific covering of certain parts of the IOL relative to other parts, as will be described in more detail below. Furthermore, the awning 2110 may have intermittent or discontinuous sections, such as slits or brush-like structures, to improve the flexibility of each lens insertion.

[0044] Recesses 2104, sized to accommodate at least a portion of the IOL 110, can be defined by the forward-facing surface of the rear platform 2105, the inner surface of the side wall 2112, and the inner surface of the awning 2110. The height or volume of each recess 2104 may be sufficient, both in terms of its front-to-back thickness and its depth or distance from the central axis CA of the central opening 2115, to accommodate one or at least a portion of each of the tactile sections 114. The inner surface of the side wall 2112 can further function as a support surface for the tactile sections 114, providing counteracting pressure to the tactile sections to help center the IOL 110 on the device 2100. The awning 2110 can restrict the forward Z-axis movement of the tactile sections 114, helping to secure the IOL 110 to the device 2100. Secure fixation of IOLs, including one-piece IOLs, enables the use of IOLs requiring tight centering tolerances (e.g., annular lenses, multifocal lenses, extended depth of focus (EDOF) IOLs, and accommodating IOLs). The sidewalls 2112 and awnings 2110 have sufficient arc length to accommodate various tactile part configurations.

[0045] The size of the recess 2104 (e.g., height) between the awning 2110 and the rear platform 2105 can vary along the awning 2110 and, in some embodiments, can be narrower or shorter in some areas than the front-to-rear thickness of the IOL tactile section 114. As previously mentioned, the height of the recess between the front-facing surface of the rear platform 2105 and the inward-facing surface of the awning 2110 can be about 0.65 mm to about 0.75 mm. This height does not need to be constant. A first area of ​​the awning 2110 can project forward more than other areas of the same awning 2110 (e.g., the area covering the end of the tactile section 114). A first area of ​​a higher awning 2110 can form a larger space sufficient to accommodate the IOL joint (e.g., joint cover 2130). A second area of ​​a lower awning 2110 can form a smaller space. The narrower space formed by the awning 2110 can compress the IOL tactile portion 114 within the space, biasing the end of the tactile portion 114 toward a more rearward position than it would otherwise be biased to achieve. As will be described in more detail below, the rear platform 2105 may include a perimeter notch 2144 positioned to align with the tactile portion 114 of the IOL 110 when the IOL optical element 112 is supported by the rear platform 2105 (see Figures 8A–8E). The notch 2144 is sized and shaped to accommodate the IOL tactile portion 114, allowing the IOL tactile portion to recede into the notch 2144 below the height of the front-facing surface of the rear platform 2105. Figure 8F shows a side view of an embodiment of the device 2100.

[0046] The wall thickness of one or more awnings 2110 and / or side walls 2112 may be uniform or non-uniform. In some embodiments, each awning 2110 and / or side wall 2112 may have a uniform thickness of about 0.35 mm. The material forming the awnings 2110 and / or side walls 2112 may be continuous or discontinuous. Discontinuous material may form a scaffold that minimizes the overall volume of the device 2100 while still providing a protective surface and / or support surface for the IOL 110.

[0047] As described above, the outer region 2111 of the platform 2105 can be substantially non-circular (e.g., rectangular, elliptical, oblong, hourglass, or freeform) in shape, having a major axis defining the long side 2108 and a minor axis defining the short side 2107. In contrast, the inner circumference or inner wall 2109 can define a circular central opening 2115. In this embodiment, the recess 2104 formed by the awning 2110 can be positioned opposite each other with respect to its major axis so that the span of the IOL 110 tactile portion 114 can be accommodated within the recess 2104. The non-circular shape of the outer region 2111 may also be a rounded triangular shape with multiple lobes projecting outward from multiple sides, as described elsewhere in this specification. The awnings 2110 can project onto the forward-facing surface of the rear platform 2105 so that they are positioned substantially opposite each other. Regardless of orientation, the span of the recess 2104 defined by the awning 2110, the side wall 2112, and the rear platform 2105 is sufficient to accommodate the span of the IOL tactile portion 114 between them. The IOL can be inserted into the recess 2104 under the awning 2110 and between the side wall 2112. The diameter between the first opposing side wall 2112 and the second opposing side wall is sufficient for IOL insertion. The IOL is typically foldable, and therefore the diameter between the first awning 2110 and the second awning can vary considerably. In other embodiments described in more detail below, the platform 2105 may have a wide cutout 2144 such that the outer region 2111 of the rear platform 2105 is radially inward of the side wall 2112 of the device 2100. This allows the side walls 2112 of the device 2100 to provide the device 2100 with a first shape different from the shape of the rear platform 2105. For example, the side walls 2112 can form a polygonal shape relative to the device 2100, and the rear platform 2105 can be substantially annular (see Figure 8C).

[0048] The span of the recess 2104 can accommodate the span of the IOL tactile portion 114, but the span of the recess may be slightly smaller than the span of the IOL tactile portion 114 so that the tactile portion 114 is positioned in a slightly compressed state by the inner support surface of the side wall 2112. The IOL 110 can be restoring to a predetermined position relative to the device 2100 such that the tactile portion 114 is at least partially bent. If the fit is too small and the tactile portion 114 is severely bent, the optical element 112 of the IOL 110 may be distorted. If the fit is too loose and the tactile portion 114 is not in contact with the side wall 2112, the optical element 112 of the IOL 110 may not be stable relative to the device and may consequently move and / or fall out of the device 2100. Figures 1E and 1F show the dimensions of the device 2100 for housing the IOL 110. One or more recesses 2105 can be sized to accommodate at least a portion of the IOL 110, and can be provided as an arc length to give the device 2100 wiggle room for IOL rotation during implantation (for example, as a thickness in the Z-axis), or as a width to provide some coverage so that the tactile edge does not come into contact with the iris. The depth of the recess 2104 between the inner surface of the awning 2110 and the front-facing surface of the platform 2105 (arrow A in Figure 1E) can be about 0.15 mm to about 1.50 mm. The width across the platform 2105 between the side walls 2112 along the minor axis (arrow B in Figure 1F) can be about 6.0 to about 11.0 mm. The span between opposing recesses 2104 (arrow C in Figure 1F) can be about 8.0 mm to about 12.5 mm. In another embodiment, the platform is approximately 10.2 mm long, 7.0 mm wide, and 0.60 mm deep. In a further embodiment, the platform along the long axis of the device may have an external length of approximately 9.2 mm and an internal length along the same axis of approximately 8.5 mm, such that the side wall thickness is approximately 0.7 mm. In a further embodiment, the platform along the long axis can be increased to approximately 11 mm, with an internal length along the same axis of approximately 9.8 mm. As a result, the side wall thickness increases by approximately 1.2 mm.The increased cavity length, combined with the increased sidewall thickness, can provide more space to operate the IOL, resulting in an increased overall device length. The device can be fixed through the plane of the ciliary apex and therefore behind the ciliary apex, and as a result, even if the device on the plane of the ciliary apex is too wide, there may still be space to embed a larger IOL housing (see Figure 18H).

[0049] The apparatus described herein is also configured for optical capture techniques. The IOL 110 can be positioned relative to the apparatus 2100 such that the optical element 112 of the IOL 110 is biased to the rear of the rearmost surface of the apparatus 2100, while the tactile portion 114 of the IOL 110 remains in front of the rearmost surface of the apparatus 2100. The tactile portion 114 of the IOL 110 can be positioned within a recess 2104 of the apparatus 2100, and at least a portion of the optical element 112 of the IOL 110 can be biased to the rear of the apparatus 2100 through an opening 2115 of the platform 2105. The edge of the IOL optical element can be positioned behind the rearmost surface of the apparatus 2100, while the tactile portion 114 extends forward through the opening 2115 so as to remain in front of the rearmost surface of the apparatus 2100.

[0050] As previously mentioned, the front opening 2127 may have a larger diameter than the central opening 2115 of the rear platform 2105. Figures 1A and 3 show the central opening 2115 extending through the rear platform 2105 as seen through the larger front opening 2127. The central opening 2115 is preferably circular, but the front opening 2127 does not have to be circular. Figure 3 shows a circular central opening 2115 and a substantially elliptical front opening 2127. Figure 1C shows a circular central opening 2115 and a substantially rectangular front opening 2127. The front opening 2127 may have any of the following geometric shapes or freeform shapes. In some embodiments, the front opening 2127 may incorporate one or more outer croppings configured to extend over and cover a selected area of ​​the IOL 110, as will be described in more detail below. The anterior opening 2127 may also incorporate one or more centrally extending features to allow direct visualization of the device 2100 through the pupil during implantation, even if the pupil narrows in size during surgery. The centrally extending features may project to define at least one narrower diameter around the anterior opening 2127, ranging from less than about 7 mm to about 5 mm, preferably about 6 mm. The centrally extending features are described in more detail below with reference to Figures 18E to 18J.

[0051] The front opening 2127 can be larger than approximately 6 mm so that the IOL can be operated into place and fully extended into place together with the recess 2104. The diameter of the front opening 2127 can be greater than 6 mm and up to approximately 8 mm. Figure 1C shows a substantially rectangular front opening 2127 with a width between the side walls 2112 along arrow A and a length between the awning 2110 along arrow C. The width and length can be approximately 5 mm to approximately 10 mm. For a substantially rectangular opening 2127, the length is greater than the width. The dimension along arrow B in Figure 1C can also be between 5 mm and 10 mm. In the scenario where the dimension is 5 mm around the entire perimeter, the side walls 2112 and awning 2110 mimic a front pouch, the front opening 2127 mimics a pouch incision, and only the central optical element 112 of the IOL 110 is exposed through the front opening 2127. Preferably, the front opening 2127 is larger than this, with a width along arrow A in Figure 1C of approximately 6.25 mm, a length along arrow C in Figure 1C of approximately 7.5 mm, and a dimension crossing arrow B in Figure 1C of approximately 8.0 mm.

[0052] As previously mentioned, the front opening 2127 may be circumferential and the awning 2110 may be relatively large, sized to accommodate the outer periphery of the tactile portion 114 of the IOL 110. This larger size of the front opening 2127 allows the device 2100 to accept any of a variety of IOLs almost universally. This larger size, which facilitates the insertion of the IOL 110, also allows certain portions of the IOL 110 that may be preferable to cover when implanted in front of the lens capsule to be exposed through the front opening 2127. Figure 5A shows an embodiment of the device 2100 having a front opening 2127 defined by a pair of awnings 2110 and a pair of bonding covers 2130. In this embodiment, the device 2100 has a substantially rectangular or hourglass shape, and the awnings 2110 project onto the rear platform 2105 from the side walls 2112 of each short side 2107 of the rectangle. The first joint cover 2130 can be positioned near the first corner of the device protruding from the side wall 2112, near where the first elongated side 2108 intersects with the first short side 2107. The second joint cover 2130 can be positioned near the opposite corner of the device protruding from the opposite side wall 2112, near where the opposite elongated side 2108 meets the opposite short side 2107. This arrangement ensures that the joint cover 2130 extends from the side wall 2112 beyond the position of the main hinge point of the tactile portion 114 and / or beyond the joint 115 where the tactile portion 114 connects to the optical element 112 of the IOL 110. The presence of the joint cover 2130 gives the front opening 2127 a free shape. The front opening 2127 can have a larger opening dimension along arrow B in Figure 5A and a smaller opening dimension along arrow D in Figure 5A. IOL110 can be inserted through the front opening 2127 along the first orientation to take advantage of the larger opening dimensions along arrow B. Once positioned through the front opening 2127, IOL110 can be rotated about a distance along the central axis CA toward arrow D, ensuring that the tactile joint 115 is covered by the joint cover 2130 and that IOL110 is secured to the platform 2105.The presence of the joint cover 2130 allows the size of the awning 2110 to be minimized and the size of the front opening 2127 to be maximized.

[0053] As described above, the device 2100 may include stabilizing features provided by a plurality of radially extending structures coupled to the main body. The radially extending structures, or bumpers 2114, provide the radial outermost part of the device to assist in centering the device 2100 within the eye and to sutureless positioning of the device within the eye, such as in the posterior chamber. In some embodiments, the device 2100 is configured such that the rearward-facing surface of the posterior platform 2105 abuts against the anterior portion 34 of the lens capsule, allowing the lens capsule to provide Z-axis support to the device 2100 (see Figure 2A). Bumpers 2114 may extend outward from the device to provide X-axis and Y-axis support to the device 2100 and help prevent rotation of the device 2100 in the Z-plane. The ciliary body 15 is approximately circular or elliptical, with its longitudinal axis being on average 0.5 mm longer than its transverse axis. A substantially circular or elliptical device 2100 can result in centering with a similarly circular or elliptical ciliary body. However, matching the shapes to obtain 360-degree contact between the device 2100 and the ciliary body 15 can result in inflammation or injury, which can adversely affect aqueous humor production. A bumper 2114 can project beyond the periphery of the platform 2105 to allow intraocular centering of the device 2100 without 360-degree contact with the ciliary body 15 or ciliary groove 25. In a preferred embodiment, the device 2100 has an outer surface having a substantially non-circular geometric shape. The platform 2105 may have an outer region 2111 that is substantially rectangular or hourglass-shaped. A bumper 2114 can extend outward beyond the periphery of the platform 2105, further reinforcing this non-circular geometric shape. For example, in the embodiment of the device 2100 shown in Figures 1A to 1F, the bumpers 2114 are positioned at each corner of the rectangular body and are configured to engage with the ciliary body 15 and / or ciliary groove 25 along less than 360 degrees. The non-circular outer shape of the device 2100 allows the device 2100 to be centered without 360-degree contact with the ocular tissue along its substantially non-circular outer surface. The shape of the device 2100 can provide sufficient contact between the bumpers 2114 and the ocular tissue (e.g., the ciliary body or lens capsule) to assist in centering and supporting the IOL 110 without causing inflammation and injury.

[0054] The bumpers 2114 can be arranged symmetrically with respect to the main body. The device 2100 can be substantially rectangular in shape and may include four bumpers 2114 projecting outward from each corner. The device 2100 may also include just two bumpers 2114 projecting outward from each short side 2107 or each long side 2108. In yet another embodiment, the device 2100 may incorporate a single bumper 2114 projecting outward from the device, or a number of other bumpers 2114 arranged symmetrically around the perimeter of the device 2100. The device 2100 may incorporate any number of bumpers 2114, including one, two, three, four, or more.

[0055] In some embodiments, the shape of the bumper 2114 allows contact with ocular tissue at an angle of about 120 degrees or less, preferably between 20 and 40 degrees. The contact between each bumper 2114 and adjacent ocular tissue may vary depending on the bumper configuration and the patient's anatomical structure. In some embodiments, each bumper 2114 can contact ocular tissue at an angle of about 5 to about 10 degrees, or preferably less than about 30 degrees. Devices with more bumpers 2114 can have a greater degree of ocular tissue contact than devices with fewer bumpers 2114. Minimizing contact between the bumper 2114 and ocular tissue significantly reduces the risk of inflammation or impaired aqueous humor production. The substantially non-circular shape of the device, partially provided by the bumpers 2114, allows for gentle contact between the device 2100 and the ciliary body, enabling centering without requiring a precise match to the patient's specific dimensions. The radius of curvature of the bumper 2114 can be smaller than the radius of curvature of the ciliary process. Therefore, the bumper 2114 can contact the ciliary process at one, two, three, or four different points, rather than over a calculable range. For example, during use, the substantially non-circular outer surface of the device 2100 can contact the ciliary process at these distinct points.

[0056] In other embodiments, the bumper 2114 of the device 2100 can be positioned near the ocular tissue (e.g., the ciliary body) after implantation, while avoiding contact with the ocular tissue. This positioning allows the bumper 2114 to assist in centering the device. If the device 2100 is positioned too far in one direction, adjacent bumpers 2114 can contact the ciliary body during implantation, biasing the device 2100 away from the ciliary body and facilitating more central positioning of the device 2100. Once implanted, the bumper 2114 of the device can be positioned near the ocular tissue (e.g., the ciliary body) with or without contact with the ocular tissue. The bumper 2114 can substantially align the central axis CA of the device 2100, which extends through the central opening 2115, with the visual axis of the eye, allowing the plane of the rear platform 2105 to be stabilized substantially parallel to the Z-plane (vertical plane) of the eye. The central axis CA of the device 2100 does not need to be perfectly aligned (coincident) with the visual axis of the eye.

[0057] The bumper 2114 can be a discontinuous or interrupted structure having one or more openings extending through it. For example, the bumper 2114 can be molded as part of a torus or ring having an inner and outer diameter. The bumper 2114 can be coupled to the rear platform 2105 or side wall 2112 of the device 2100 so as to project outward away from these areas. Both ends of each bumper 2114 can be coupled to the device 2100, or only one end of each bumper 2114 can be coupled to the device 2100 to give each bumper 2114 a C-shape. Thus, the bumper 2114 can be any of various tactile part types, with or without closed loops, open loops, plates, Kermans, and one or more openings extending through them.

[0058] In some embodiments, the bumper 2114 forms a maximum outer diameter on the device 2100 sufficient to center by contact with the ciliary body and / or ciliary grooves. In some embodiments, the bumper 2114 is a torus-shaped feature that projects outward from each corner of the rectangular rear platform 2105. The bumper 2114 may have first and second ends 2132, 2134 that project from the main body region, for example from the side wall 2112, from the outer region 2111 of the rear platform 2105, or from another outer surface of the device, and an intermediate region 2136 located between the ends 2132, 2134 (see Figure 1F). Each bumper 2114 may have a radial cross-section of about 1.10 mm to about 1.0 mm and an axial cross-section of about 0.1 mm to about 1.0 mm, or about 0.2 mm to about 0.4 mm. In some embodiments, the axial cross-section is sized to allow the bumper 2114 to be inserted into the ciliary sulcus. The distance by which each bumper 2114 protrudes beyond the side wall 2112 of the main body may vary. Each bumper 2114 may have an inner diameter ID measured from the outer surface of the side wall 2112 to the inner surface of the intermediate region 2136 of the bumper 2114. The inner diameter can be approximately 0.25 mm to approximately 3.0 mm. Each bumper 2114 may have an outer diameter OD measured from the outer surface of the side wall 2112 to the outer surface of the intermediate region 2136 of the bumper 2114. The outer diameter can define the maximum outer diameter of the device 21000 formed by the bumper 2114. This maximum outer diameter can be approximately 12.5 mm to approximately 16.0 mm, or 9.0 mm to approximately 13.0 mm. The device 2100 is configured to be positioned in the posterior chamber. The bumper 2114 can be positioned within the ciliary groove during use, but is not required. In some embodiments, the bumper 2114 can be defined with a maximum outer diameter such that it is inserted into the ciliary groove when the device is centered around the visual axis. In other embodiments, the bumper 2114 can be defined with a maximum outer diameter such that it remains outside the ciliary groove when centered around the visual axis. Bumpers 2114 protruding from the periphery of the device can be sized such that they abut or lightly contact the ciliary tissue to restrict rotation. The bumper 2114 can also potentially assist in centering the device.For example, the bumper 2114 may be thin and assist in centering, but may be positioned relatively posteriorly so as not to protrude into the ciliary sulcus while the device 2100 is implanted in the eye.

[0059] In one embodiment, the length of the device 2100 between the outer surface of the bumper 2114 on the short side 2107 and the outer surface of the bumper 2114 on the opposite short side 2107 (arrow L in Figure 1F) can be approximately 6 mm to approximately 12 mm. The width of the device 2100 between the outer surface of the bumper 2114 on the long side 2108 and the outer surface of the bumper 2114 on the opposite long side 2108 (arrow W in Figure 1F) can be approximately 7 mm to approximately 14 mm. The bumper 2114 can protrude outward by a distance that allows the bumper 2114 to contact the ciliary tissue rather than the side wall 2112 or rear platform 2105 of the device 2100, thereby providing a center and preventing rotation. Figures 2A and 2B show the bumper 2114 protruding into the cilia groove 25, but the main body formed by the rear platform 2105, side wall 2112, and awning 2110 preferably remains substantially within the space defined by the cilia 15 without contacting the cilia 15.

[0060] The bumper 2114 can bias the device 2100 away from adjacent ocular tissue upon contact. The discontinuity of the bumper (i.e., the internal volume defined by the inner diameter of the torus) provides the bumper 2114 with a high degree of flexibility and springiness when it contacts ocular tissue, compared to the outer diameter of a solid piece of material. In some embodiments, the bumper 2114 can deform slightly or collapse slightly inward upon contact with the ciliary structure. The deformation of the bumper 2114 may be temporary, allowing it to return to its original shape and thereby push the device 2100 away from ocular tissue towards a concentrated position within the eye. The compression of the bumper does not adversely affect the performance of the device 2100; that is, one or more of the bumpers 2114 can be compressed while the rest of the device 2100 provides proper IOL capture, centering, tilting, etc.

[0061] The bumpers 2114 can protrude sufficiently from the outer region of the device so that they are positioned close together, but preferably to avoid remaining in contact with the ciliary structure after the device 2100 is implanted. The bumpers 2114 act as guides when positioning the device 2100 in the eye, preventing displacement in the Z-plane and maintaining proper alignment between the central opening 2115 and the visual axis of the eye during implantation. The smooth, convex outer surface of the bumpers 2114, which are torus or rounded ring shapes without square edges, also ensure that contact between the ocular tissue and the bumpers 2114 is non-traumatic. The bumpers 2114 have a minimum thickness in the anterior-posterior (i.e., axial cross-section) to limit interaction with the iris and avoid adhesion and angle closure.

[0062] Figures 4A and 4B show the implementation of the device 2100 and bumpers 2114 angled with a forward bias to keep the IOL 110 behind the iris. As previously mentioned, each bumper 2114 can be a torus-shaped feature that projects outward from the device 2100. The first and second ends 2132, 2134 of the bumpers 2114 can be positioned behind the intermediate portion 2136 of each bumper 2114, which extends slightly forward. The intermediate portion 2136 of each bumper 2114 can come into contact with the eye tissue, and this slight forward bias helps to bias the rest of the device 2100 further rearward, thus avoiding contact with and abrasion of the iris. In some embodiments, the bumpers 2114 can project from the front of the device 2100, or the intermediate portion of each bumper 2114 can be angled to project forward of the front of the device 2100 formed by the awning 2110. The device 2100 may be driven backward when one or more of the bumpers 2114 are compressed due to the angle of the bumpers 2114. Furthermore, one or more surfaces of the bumpers 2114 may be textured or featured to increase friction with the ciliary process or ciliary groove, thereby limiting the rotation of the device 2100 relative to the eye.

[0063] The device 2100 may, in addition to the above, include one or more stabilizing features 2138 that can be positioned rearward or forward of one or more recesses 2104 of the main body, the main body being formed by a rear platform 2105, side walls 2112, and an awning 2110. Figures 5A-5C, 6A-6E, 8A-8F, 9A-9B, 18B-18D, and 19A-19B show embodiments of the device having a rear stabilizing feature 2138 positioned rearward of the recess 2104. Figures 10A-10D show embodiments of the device having a front stabilizing feature 2138 positioned forward of the recess 2104. Various embodiments of the device are described in more detail below.

[0064] The stabilizing feature 2138 can project rearward from the rearward-facing surface 2140 of the rear platform 2105, and can project laterally outward along the rearward-facing surface 2140, thereby defining a space 2142, within which the anterior portion 35 of the lens capsule around the capsulotomy 40 can be positioned. The stabilizing feature 2138 is configured to be positioned rearward of the anterior capsule 35, with the rest of the device 2100 positioned anterior to the lens capsule providing Z-axis support. The stabilizing feature 2138 can engage with the capsulotomy 40 in the anterior capsule 35 to prevent accidental movement of the device 2100 after it has been implanted. The stabilizing feature 2138 can align the central axis CA of the device 2100 with respect to the lens capsule 35, ensuring proper positioning of the optical elements 112 of the IOL 110 engaged with the device 2100 relative to the visual axis of the eye.

[0065] The configuration of the stabilizing feature 2138 can vary. The stabilizing feature 2138 may include an open loop, a closed loop, a plate, a wing, a continuous elliptical feature, a flexible finger-like projection, or other configurations. Generally, the stabilizing feature 2138 includes one or more projections that are inserted through the capsulotomy 40 and configured to engage with the anterior inner surface of the lens capsule 35, such that the surface 2140 facing the rear of the rear platform 2105 is fixed against the anterior outer surface of the lens capsule 35. In this specification, any of the various structures of the stabilizing feature 2138 can be considered, which can provide both a rear projection and a circumferential projection configured to engage with the capsulotomy 40, preventing the device 2100 from sliding forward against the lens capsule 35.

[0066] In one embodiment, the stabilizing feature 2138 may have a first portion 2116 and a second portion 2118 coupled to the first portion 2116 and extending laterally outward therefrom. The first portion 2116 may be positioned near the inner wall 2109 of the rear platform 2105 defining the central opening 2115. The first portion 2116 may project a distance rearward from the rear-facing surface 2140 of the platform 2105, thereby defining the size of the space 2142 between the rear-facing surface 2140 and the second portion 2118. The distance by which the first portion 2116 projects is sufficient to allow the anterior portion 35 of the lens capsule to be inserted between the rear-facing surface 2140 of the platform 2105 and the second portion 2118, thereby engaging the capsulotomy 40 with respect to the first portion 2116. The first portion 2116 can be a ring-shaped structure that defines an outer diameter large enough to pass through and engage with the anterior capsulotomy 40. However, the first portion 2116 does not need to be perfectly ring-shaped. For example, the first portion 2116 can be formed by a plurality of projections (see Figures 5B-5C, 6A-6C, 8A-8F) arranged on either side or around the central opening 2115.

[0067] The second portion 2118 of the stabilizing feature 2138, which projects laterally outward from the first portion 2116, can have a larger outer diameter than that defined by the first portion 2116. As previously stated, the first portion 2116 extends within the capsulorhexis 40 and is sized to be received by the capsulorhexis. The second portion 2118 is sized to extend along the inner surface of the anterior capsule 35, by a distance within the lens capsule (or behind the anterior part of the lens capsule in scenarios where a complete capsule does not exist). Thus, the anterior capsule 35 of the lens capsule can be positioned between the second portion 2118, which is located behind the lens capsule, and the surface 2140 facing the rear of the platform 2105, which is located in front of the lens capsule. The second portion 2118 can be a pair of wings extending outward in opposite directions. The second portion 2118 of the stabilizing feature 2138 can project outward by a certain distance beyond the opposite rear platform 2105. For example, each of the second portions 2118 may have a length greater than the distance between the inner wall 2109 and the outer region 2111, such that each of the second portions 2118 extends a certain distance beyond the outer region 2111 on both opposing sides (see Figure 5A). The stabilizing feature portion 2138 may have a span along the minor axis of the device 2100 that is greater than the span of the rear platform 2105 along the minor axis of the device 2100. Typically, the second portion 2118 protrudes outward from around the rear platform 2105 in at least two regions, but the second portion 2118 may protrude outward from one, two, three, or more regions, and outward from the entire perimeter of the platform 2105. The rear platform 2105 (and the device 2100) may have any of a variety of shapes, including rounded rectangles, ovals, ellipses, triangles, etc. If the rear platform 2105 has a rectangular, elliptical, or hourglass shape with a long side 2108 and a short side 2107, the second portion 2118 can form two wings projecting outward from each of the long sides 2108. The outwardly projecting second portion 2118 may be located below the recess 2113 on the long side 2108.The hourglass-shaped contour provided by the recess 2113 allows the stabilizing feature 2138 to contact the rear surface of the device with a specific minimum diameter and extend only by a specific minimum radial distance, but still visible from the top view (see Figures 19A-19B). The distance the second portion 2118 extends radially outward can be minimized, thereby facilitating the insertion process of the device while also providing sufficient stability to the lens capsule. If the rear platform 2105 has a triangular shape with three lobes or angles and three sides, the second portion 2118 can form three wings projecting outward from each side of the rounded rectangle between the lobes. If the rear platform 2105 has a circular shape, the second portion 2118 can project outward along the entire circumference of a circle, forming a fully elliptical or circular flange that projects outward and provides 360-degree support and stabilization to the anterior capsule. These are some examples of combinations of periphery shape and winged projections. Others are considered herein.

[0068] The relative position of the stabilizing feature section 2138 can vary such that the span of the second section 2118 is aligned with the short axis of the device 2100 or with the long axis of the device. The stabilizing feature section 2138 shown in Figure 5A is positioned to project outward from the two long sides 2108 of the main body and is configured to engage with the lens capsule. The stabilizing feature section 2138 can be positioned such that the wings formed by the second section 2118 are perpendicular or orthogonal to the opposing recesses 2104 into which the tactile section 114 of the IOL 110 is inserted. In other words, if the opposing recesses 2104 are located on the short side 2107 of the device 2100, the opposing wings of the stabilizing feature section 2138 can be located on the long side 2108 of the device 2100. However, the wings of the stabilizing feature section 2138 can be positioned around the device 2100 in any of the various orientations to provide engagement and stability with the anterior capsule 35.

[0069] The external dimensions of the second portion 2118 projecting outward from the periphery of the rear platform 2105 can be any of a variety of shapes, including oval, elliptical, rectangular, square, triangular, or other freeform shapes. The external dimensions can also be curved or project along other dimensions. For example, the second portion 2118 may be in a plane parallel to the rear platform 2105, spaced at a distance equal to the longitudinal length of the first portion 2116 (see Figure 5B). Alternatively, the second portion 2118 of the stabilizing feature 2138 may also have an angle or curvature or outward ridge configured to engage with the inner surface of the anterior capsule, which gives the device 2100 a rearward bias. The stabilizing feature 2138 may have interruptions within these wings that project outward from the periphery of the platform 2105. For example, the second portion 2118 located inside the lens capsule may include one or more openings extending through the wing region. The opening or interruption may also include one or more recesses, grooves, or other surface features near the outer periphery of the second portion 2118. These can provide flexibility during handling and allow fluids such as viscoelastic fluids to escape from the inside of the lens capsule.

[0070] The stabilizing feature 2138 can engage with the capsulotomy 40 to center the device 2100. The capsulotomy 40 may have a diameter between approximately 4 mm and 7 mm, or between approximately 5 mm and 6 mm. The first portion 2116 may be at least the same size as the diameter of the central opening 2115 and spaced apart from each other by a distance slightly larger than that of the capsulotomy 40. The larger dimensions allow the capsulotomy 40 to be positioned under a small amount of tension to improve the fixation of the device 2100 to the lens capsule. In one embodiment, the capsulotomy is approximately 5.5 mm, and the outer diameter defined by the first portion 2116 may be approximately 6.0 mm, whether it is completely annular or formed by a pair of projections. Other sizes are considered herein.

[0071] The rearward-facing surface 2140 of the platform 2105 can abut against the outer surface of the anterior capsule 35 of the lens capsule, the first portion 2116 of the stabilizing feature 2138 can engage with the capsulotomy 40, and the second portion 2118 of the stabilizing feature 2138 can be inserted into the capsule and abut against the inner surface of the anterior capsule 35 of the lens capsule. Z-axis support can be provided by the anterior capsule 35 of the lens capsule, and centering of the device 2100 can be achieved by the engagement between the stabilizing feature 2138 and the capsulotomy 40. The device 2100 does not need to engage with or contact the ciliary process or ciliary groove for centering. IOL 110 can enhance the device 2100 and increase the stability of these capsulotomy engagement features.

[0072] Figures 6A to 6E show embodiments of the apparatus 2100 having multiple bumpers 2114 and stabilizing feature sections 2138. The rear platform 2105 has a rounded rectangular shape with four bumpers 2114, each bumper projecting outward from the periphery of the platform 2105 near the corners of the rectangle. The wings of the second portion 2118 of the stabilizing feature section 2138 extend outward from the elongated side 2108 between the bumpers 2114. In this embodiment, the wings of the second portion 2118 have a circular or elliptical shape, but it should be understood that any of the various shapes are considered. Figure 6B shows a rear perspective view of the apparatus 2100. The bumpers 2114 project radially outward so that the entire bumper 2114 lies in a single plane parallel to the surface facing the rear of the platform 2105. The bumper 2114 can be inclined with respect to the rear-facing surface of the platform 2105, as described above, such that the intermediate portion 2136 is positioned forward of the ends 2132, 2134. The ends 2132, 2134 of the bumper 2114 are also coupled to the rearward region of the side wall 2112. The ends 2132, 2134 of the bumper 2114 may also be coupled to the forward region of the side wall 2112. The embodiment shown in Figure 6A also has four bumpers 2114, each bumper 2114 projecting outward from the corners of the rectangular body. It should be understood that the device may include two bumpers 2114 projecting outward across the rectangular short end 2107, such that the intermediate portion 2136 extends around the entire short end 2107, with the first end 2132 coupled to the side wall 2112 near the first long end 2108, and the second end 2134 coupled to the side wall 2112 near the opposite long end 2108.

[0073] Figures 6B–6C show a stabilizing feature 2138 projecting rearward from the rear-facing surface 2140 of the rear platform 2105, such that the plane of the wing 2118 is behind the plane of the bumper 2114. This allows the wing 2118 of the stabilizing feature 2138 to be positioned behind the anterior portion 35 of the lens capsule while the bumper 2114 can be inserted into the ciliary groove 25 (see Figure 6E). The space 2142 between the wing 2118 and the rear-facing surface 2140 of the rear platform 2105 allows the anterior portion 35 to be received internally, thereby allowing the capsulotomy 40 to surround the first portion 2116 of the stabilizing feature 2138. Figure 6E shows the posterior portion of the missing lens capsule. The IOL 110 is shown positioned within the main body forming a partial lens housing for the IOL. The optical element 112 of the IOL 110 is positioned between the side walls 2112 and toward the forward-facing surface of the rear platform 2105, thereby covering the central opening 2115. The IOL 110, covering the rear surface 2140 of the rear platform 2105, the stabilizing feature 2138, and the central opening 2115, can form a barrier between the posterior chamber and the vitreous humor. The forward-facing surface of the awning 2110 is positioned behind the iris 10. Preferably, the awning 2110 does not come into contact with the iris 10, but the smooth outer surface of the awning 2110 is designed so that the iris 10 is not damaged or irritated if it does come into contact. The bonding cover 2130 provides additional covering for the tactile portion 114, where it forms a bonding portion 115 with the optical element 112 of the IOL 110, preventing this area from coming into contact with the iris 10.

[0074] The apparatus 2100 described herein can incorporate any combination of stabilization features. In some embodiments, the apparatus 2100 includes a plurality of bumpers 2114 configured to extend toward the ciliary body structure and a stabilization feature 2138 positioned further rearward to engage with at least a portion of the lens capsule (see Figures 6A-6E, 8A-8F, and 9A-9B). In other embodiments, the apparatus 2100 includes only a plurality of bumpers 2114 without the stabilization feature 2138 (see Figures 1A-1F, 2A-2B, 3, and 4A-4B). In some embodiments, the apparatus 2100 does not include the bumpers 2114 and the stabilization feature 2138 positioned further rearward relative to the body of the apparatus, and the stabilization feature is configured to engage with at least a portion of the lens capsule while the body of the apparatus is positioned anterior to the capsulotomy (see Figures 5A-5C). In yet another embodiment, the device 2100 does not include a bumper 2114 and a stabilizing feature 2138 positioned further forward than the body of the device, the stabilizing feature being configured to engage with at least a portion of the lens capsule while the body of the device is positioned behind the capsulotomy (see Figures 10A to 10D). Some of the devices described herein are configured such that the majority of the device is positioned anterior to the lens capsule and supported by the anterior part of the capsule. Other devices described herein are configured such that the majority of the device is positioned within the lens capsule, while still being supported by the anterior part of the lens capsule (e.g., the capsulotomy). These are described in more detail below.

[0075] The stabilizing features ensure secure positioning relative to the lens capsule and / or ciliary sulcus, allowing the device 2100 to remain in contact with or fixed to the anterior part of the lens capsule. In some embodiments, the device 2100 may further incorporate a tether 2120 (also referred to herein as a fixing arm) to prevent rotation of the device 2100 around the visual axis in the Z-plane (vertical plane) of the eye. Figure 7 shows an embodiment of the device 2100 incorporating a tether 2120 protruding from the side wall 2112. The tether 2120 may protrude from any of the following locations on the device 2100, including the short side 2107, the long side 2108, or a corner or vicinity of a corner of the device 2100. The tether 2120 may be designed to have rigidity and length, allowing it to act as a rigid spacing element. The tether 2120, which is rigid or can be subjected to spring force, may rely on penetrating or being pressed into place by adjacent tissue. Preferably, the tether 2120 is highly flexible so that it does not cause centering of the device 2100 and the IOL position is not determined by the patient's scleral diameter. In one embodiment, the device 2100 may include a posterior stabilizing feature 2138 and the tether 2120 for limiting rotation without applying excessive resistance force. The device may include a single tether 2120 as shown in Figure 7, or may incorporate one, two, or three tethers or anchoring arms that are fixed transsclerally using an external anchor 2125, as described in U.S. Patent Application No. 16 / 988,519 filed August 7, 2020, which is incorporated herein by reference in its entirety. In other embodiments, the tether 2120 may be fixed to the iris or another part of the eye. The anti-rotation tether 2120 can be particularly useful when the device is intended to be used with an annular IOL, in which case even a small amount of rotation around the visual axis can result in serious distortion. The tether 2120 can provide artificial banding to stabilize the device.

[0076] The device may include at least three fixed arms 2120 configured to be positioned under tension to place and stabilize the device within the eye. Each of the three fixed arms 2120 may extend outward from each of a plurality of sides. One or more of the fixed arms 2120 may be substantially linear between their origin 2103 and their end 2102, which have a support structure. A linear or forward fixed arm 2120 may extend along a single longitudinal axis L between its origin and end without bending or curving away from a single longitudinal axis L (see Figure 7). A linear fixed arm may extend perpendicular to the outer circumferential surface of the outer wall of the support structure. The longitudinal axis L of a linear fixed arm may be positioned perpendicular to the outer circumferential surface of the outer wall. The plane of the front-facing surface of the support structure and the longitudinal axis L of a linear fixed arm may be parallel to each other, as may the plane of the rear-facing surface of the support structure and its longitudinal axis L. Interrelated embodiments of the device 2100 having multiple fixed arms 2120 will be described in more detail below with reference to Figures 11A to 11F, 12A to 12C, 13A to 13E, 14, 15, 16A to 16C, 17, 18A to 18D, 18E to 18H, and 18I to 18J.

[0077] Figure 8A shows an embodiment of the device 2100 having a posterior platform 2105 with a central opening 2115 and a peripheral notch 2144. Figure 8E shows the device 2100 of Figure 8A with the IOL 110 positioned inside the body, and Figure 8D shows the posterior side of the device 2100, as well as the relative arrangement of the peripheral notch 2144 and tactile portion 114 of the IOL 110. The peripheral notch 2144 minimizes the bulk of the device and allows for a reduction in the overall anterior-posterior thickness. The device 2100 can be positioned in the posterior chamber of the eye, anterior to the lens capsule. The anterior-posterior thickness of the device 2100 is important in determining whether the device 2100 interacts with the posterior surface of the iris. By minimizing the anterior-posterior thickness of the device 2100, the interaction between the device 2100 and the iris is limited. The rear platform 2105 may have two peripheral notches 2144, one notch 2144 may be positioned along the first short side 2107 of the device 2100, and the second notch 2144 may be positioned along the second opposing short side 2107. This arrangement positions each notch 2144 below the position of the IOL tactile portion 114 when the IOL 110 is placed inside the device 2100. Each notch 2144 may be relatively long, such that the length of the notch 2144 extends to a length approximately equal to the length of the short side 2107. For example, a notch 2144 may extend from a corner of the device where the short side 2107 and the first long side 2108 intersect, toward the other corner where its short side 2107 intersects the opposite long side 2108. The width of the notch 2144 can vary along its length such that it is wider at the first corner and narrower at the opposite corner. The notch 2144 can be wider at the corner of the device where the IOL joint is located and narrower at the corner of the device where the end of the tactile part is located. The shape of the notch 2144 is defined by the rear-facing surfaces of the outer wall 2111 and the side wall 2112 of the rear platform 2105. The outer wall 211 can define the first side of the notch 2144, and the rear-facing surface of the side wall 2112 of the device can define the opposite side of the notch 2144. The overall shape of the notch 2144 can be similar to the shape of the IOL tactile part 114.The narrower end of the notch 2144 can be sized and shaped to accommodate the terminal region of the tactile portion 114, while the wider end of the notch 2144 can be near where the tactile portion 114 joins to the optical element 112 (see Figure 8D). The notch 2144 allows the terminal region of the flexible IOL tactile portion 114 to be biased rearward toward the region of the notch 2144, for example, by the awning 2110. The presence of the notch 2144 can form a curved outer wall 2111 to the rear platform 2105, which together with the circular inner wall 2109 forming the central opening 2115 forms an annular shape toward the rear platform 2105. In some embodiments, the notch 2144 may be wide enough so that the outer region 2111 of the rear platform 2105 is radially inward of the side wall 2112 of the device. This may result in the side walls 2112 of the device 2100 having a first shape, and the rear platform 2105 of the device 2100 having a second different shape. For example, the side walls 2112 may form a rectangular or polygonal shape relative to the device 2100, and the rear platform 2105 may be substantially annular in shape. Figure 8D shows that the side walls 2112 of the device 2100 form a substantially rectangular or square shape, while the shape of the rear platform 2105 formed by the notch 2144 is more annular. Figures 8B-8C show another embodiment of the device 2100. The notch 2144 is larger in size than the notch 2144 in Figure 8D, forming a more annular rear platform 2105. Regardless of the overall size of the notch 2144 for housing the tactile portion 114, the rear platform 2105 is sized to support the central optical element 112.

[0078] In some embodiments, the device 2100 does not have a rear support 2105, but instead uses the anterior lens capsule to support the central optical element 112. Figures 9A and 9B show the device 2100 having side walls 2112 that form an awning 2110 that curves inward and forms a surface facing forward of the device 2100. The awning 2110, combined with the side walls 2112, forms a main body that defines an internal concave region in which the IOL 110 can be positioned. The main body helps to position and secure the IOL 110 within the device 2100 while protecting the surrounding ocular tissue. The device 2100 is configured to be positioned over a capsulotomy, abutting against the anterior part of the lens capsule between the anterior part of the lens capsule and the iris in the posterior chamber. In this embodiment, the anterior part of the lens capsule is preferably intact. The anterior part of the lens capsule can provide Z-axis support for the IOL positioned behind the awning 2110. One or more bumpers 2114 protrude outward from the side wall 2112 to non-traumatically contact ciliary ophthalmic tissue such as the ciliary body or ciliary sulcus to center and prevent rotation of the device 2100.

[0079] In the embodiment of the apparatus shown in Figures 9A and 9B, the rearward-facing surface of the side wall 2112 forms the rear surface of the apparatus 2100, which forms a partial shell for the IOL. As with other embodiments described herein, the apparatus 2100 can be implanted such that the body of the apparatus 2100 remains in front of the capsulotomy and the stabilizing feature 2138 extends rearward from the capsulotomy. The bumper 2114 can extend outward from the side wall 2112 toward the ciliary sulcus. Since the apparatus lacks a rear platform 2105, the rearward-facing surface of the IOL remains exposed at the rear end of the apparatus 2100. Thus, the IOL can come into contact with at least a portion of the anterior part of the lens capsule when placed, for example, within the apparatus 2100 implanted in the eye. The frontward-facing surface of the IOL is at least partially covered by the awning 2110 and bonding cover 2130 of the apparatus 2100, thereby protecting the iris from any square edge of the IOL 110. The stabilizing feature section 2138 may include a portion 2118 that projects rearward from the device and extends laterally, as described elsewhere in this specification. When the device 2100 is positioned at the edge, the edge of the capsulotomy may extend over the portion 2118 so as to be positioned rearward of the capsulotomy. The rest of the body of the device 2100 may remain in front of the capsulotomy. The IOL, positioned in the recess defined by the side walls 2112 and the awning 2110, can be supported on the Z-plane by the anterior part of the lens capsule, even while the lateral projection 2118 of the stabilizing feature section 2138 extends rearward of the capsulotomy. The size and shape of the body prevent the device 2100 from falling through the capsulotomy into the lens capsule. Furthermore, the distance between the side walls 2112 accommodates the span of the tactile section 114. The tactile portion 114 can also be positioned slightly compressed by the inner support surface of the side wall 2112 to help hold the IOL in place, as described elsewhere in this specification.

[0080] Figures 10A–10D show embodiments of the device 2100 configured to be fixed intraocularly posterior to the capsulotomy while at least a portion of the device remains anterior to the lens capsule. While the device 2100, like other embodiments described elsewhere in this specification, can engage with the capsulotomy for fixation and stabilization, the majority of the device (and therefore the IOL is positioned within the recess of the device) is located within the lens capsule posterior to the capsulotomy 40. This implantation method eliminates the risk of iris interaction.

[0081] The device 2100 can be designed so that engagement with the capsulotomy avoids significant deformation of the shape and orientation of the device 2100. The device 2100 can incorporate one or more reinforcing members to prevent distortion. The reinforcing members allow the device to engage with the eye, e.g., the capsulotomy, to ensure secure fixation while avoiding distortion. The device described herein can be reinforced to match or exceed the compressive force applied by the lens capsule. The compressive force applied by the lens capsule depends on the diameter of the capsulotomy, and therefore the diameter of the portion of the device that engages with the capsulotomy. The compressive force applied by the lens capsule also depends on the diameter, shape, and mechanical properties of the capsulotomy. The diameter, shape, and mechanical properties of the capsulotomy can be estimated, but cannot be accurately predicted. Therefore, a device that can be adapted to various scenarios is preferred. The front and / or rear surfaces of the device 2100 can be thickened and / or reinforced with material to prevent distortion due to the force of the lens capsule on the device 2100. The side walls 2112 and / or corners of the apparatus 2100 may be thickened and / or reinforced to limit bending. Reinforcement rings may be incorporated near the location where the apparatus contacts the capsulotomy. The reinforcement rings may be made of an integrated or embedded material such as nitinol or plastic, which is more rigid than the material used to form other areas of the apparatus such as the awning 2110, the side walls 2112, or the rear platform 2105. The material is also flexible enough to be inserted through a small incision, as described elsewhere in this specification, while providing some reinforcement.

[0082] Figures 20A to 20D show devices incorporating various types of reinforcing members 145. Figure 20A shows a reinforcing member incorporated into the rear platform 2105 of the device, which is in the shape of a ring 2145. The reinforcing ring 2145 can surround the opening 2115 and can be formed by increasing the material thickness of the platform 2105 in this region or by embedding a secondary material such as plastic or metal to provide greater hoop strength. Figure 20B shows the reinforcing ring 2145 in the rear platform 2105 having a discontinuous surface due to the presence of one or more notches 2144. As discussed elsewhere in this specification, the notches 2144 minimize the bulk and thickness of the device, thereby allowing for easier insertion of the device into the eye. However, the notches 2144 can reduce the hoop strength of the device and make it more susceptible to force-induced deformation of the lens capsule. Further hoop strength of the device against the lens capsule can be provided by a reinforcing ring 2145 within the discontinuous rear platform 2105 (e.g., by embedding a polymer or material having greater rigidity than the material of the platform 2105), or by modifying the material properties of the discontinuous rear platform 2105 (e.g., the thickness of the platform in the anterior-posterior direction), while the notch 2144 ensures sufficient flexibility for inserting the device into the eye. Figure 20C shows another configuration of reinforcing in the form of one or more elongated beams 2145 along the side wall 2112 reinforcing the elongated side 2108. Figure 20D shows another embodiment in which the reinforcing ring 2145 surrounds the opening 2115 in combination with the reinforcing beams 2145 along the corner near the bumper 2114. Hereinafter, any of the various reinforcing shapes and arrangements are considered to reinforce the device while allowing insertion of the device through a small incision.

[0083] The device 2100 may incorporate a stabilizing feature 2138, as described elsewhere in this specification. The stabilizing feature 2138 may project forward from the front-facing surface of the device 2100 and may project laterally outward to define a space 2142 in which the anterior portion 35 of the lens capsule around the capsulotomy 40 can be positioned internally. The stabilizing feature 2138 is configured to be positioned anterior to the anterior capsule 35, with the remainder of the device 2100 located posterior to the capsulotomy 40. The stabilizing feature 2138 can align the central axis CA of the device 2100 with respect to the lens capsule 35, ensuring proper positioning of the optical elements 112 of the IOL 110 engaged with the device 2100 relative to the visual axis of the eye.

[0084] The configuration of the stabilizing feature 2138 can vary, but for this implementation, the stabilizing feature 2138 must not easily pass through the capsulotomy once the device 2100 is placed in the eye. The stabilizing feature 2138 may include open loops, closed loops, wings, plates, continuous elliptical features, flexible finger-like projections, or other configurations. The stabilizing feature 2138 can form a tactile portion that extends into the ciliary sulcus, similar to the tactile portion of a three-piece IOL. Figures 10A-10B show embodiments of the stabilizing feature 2138 that include two open loops configured to extend laterally outward and anterior to the capsulotomy 40 so that the anterior surface of the device (i.e., the awning 2110) engages with the ciliary sulcus while abutting the posterior surface of the lens capsule 35. In some embodiments, the stabilizing feature 2138 may be in the form of a tactile portion less than approximately 0.5 mm thick that extends into the ciliary sulcus or along the upper part of the anterior capsule for at least a certain distance.

[0085] The stabilizing feature 2138 can also be placed on the anterior pouch to support the device at the rear of the anterior pouch. Figures 10C to 10D show embodiments of the stabilizing feature 2138 including two lateral projections that extend laterally outward and to the anterior side of the pouch incision 40 so as to engage with the front surface of the pouch 35, with the front-facing surface of the device (i.e., the awning 2110) in contact with the rear-facing inner surface of the pouch 35.

[0086] Each embodiment of the stabilizing feature 2138 shown in Figures 10A and 10C may have a first portion 2116 and a second portion 2118 coupled to the first portion 2116 and extending laterally outward therefrom. The first portion 2116 may be positioned near the edge of the awning 2110 defining the opening 2127. The first portion 2116 may project forward by a certain distance from the front-facing surface of the awning 2110, thereby defining the size of the space 2142 between the awning 2110 and the second portion 2118. The distance the first portion 2116 projects is sufficient to allow the anterior capsule 35 of the lens capsule to be inserted between the awning 2110 and the second portion 2118, thereby engaging the capsulotomy 40 with the first portion 2116. The first portion 2116 may be a ring-shaped structure that defines an outer diameter large enough to pass through and engage with the anterior capsulotomy 40. However, the first portion 2116 does not need to be perfectly ring-shaped. For example, the first portion 2116 can be formed by multiple projections positioned on either side or around the opening 2127. Engagement can be achieved at just two points, similar to conventional optical capture using a cat-eye capsulotomy. The engagement can extend, for example, over an arc of approximately 2 mm to 6 mm per side. The stabilizing feature portion 2138 can be sized to accommodate capsulotomies of various sizes, such as approximately 4 mm to 7 mm, or approximately 5 mm to 6 mm. The engagement between the stabilizing feature portion 2138 and the capsulotomy 40 can restrict the translational, axial, and rotational movements of the device 2100 within the eye, and thus the IOL engaged with the device 2100. The second portion 2118 does not easily pass through the capsulotomy once the device is implanted.

[0087] Once the device 2100 is fixed and stabilized against the capsulotomy, the IOL 110 can pass through the capsulotomy and the anterior opening 2127 and be positioned in the posterior recess 2104 of the awning 2110. To reduce the risk of the IOL 110 passing behind the device 2100 during surgery, the depth of the recess 2104 between the awning 2110 and the posterior platform 2105 can be greater than the depth of the recess described for the device implementation positioned anterior to the capsulotomy. Furthermore, the central opening 2115 can have a smaller diameter than other implementations of the device positioned anterior to the capsulotomy. For example, the central opening 2115 can have a diameter of about 4.5 mm to about 5.0 mm to reduce the risk of the IOL 110 passing posteriorly to the central opening 2115. At least a portion of the posterior platform 2105 can be reinforced or thickened to increase the hoop strength of this posterior surface and reduce the possibility of the IOL 110 accidentally passing through the central opening 2115. The device 2100 is preferably designed to allow the IOL 110 to be easily inserted through the anterior opening 2127 and the capsulotomy, and to prevent the IOL 110 from easily passing through the posterior central opening 2115 of the device 2100.

[0088] Any of the features described with respect to the apparatus shown in Figures 10A to 10D, including the apparatus body configured to be positioned posterior to the capsulotomy, can be incorporated into any of the various combinations in any of the other embodiments of the apparatus described herein, including an embodiment having the apparatus body configured to be positioned anterior to the capsulotomy, and vice versa.

[0089] One or more of the fixing arms 2120 can be transscleral fixing arms, which are designed to be externalized non-traumatically and held in place solely by their shape and mechanical properties, i.e., without the need for sutures or adhesives. The outer portion of the circumferential end (also referred herein as the terminal or terminal portion) of the fixing arm 2120 or the anchor 2125 (also referred herein as the fixing footplate or footplate) can be seated subconjunctivally to fix the arm 2120 in place. In some embodiments, the conjunctiva may be destroyed and reformed after externalization. The implantation device can allow for both transconjunctival and subconjunctival placement. The anchor 2125 of the fixing arm 2120 may have a robust yet low-profile geometric shape so as to remain stable, not re-enter the eye, and not easily erode the conjunctiva. Furthermore, the fixing arms 2120 of the device 2100 may be manufactured in a manner that facilitates easy visualization and manipulation of the device before surgery. At least one of the fixed arms 2120 is manufactured to have a geometric shape that is substantially non-planar when stationary, and may then be manipulated to a planar configuration during the embedding process, for example, when placed under tension.

[0090] The device 2100 may include one, two, three, or more fixing arms 2120. In a preferred embodiment, the device 2100 includes three fixing arms 2120 arranged symmetrically or equidistantly around the support structure 2105. The fixing arms 2120 can center the lens support structure 2105 and provide sufficient support for long-term stability. In some embodiments, this can be achieved by a single fixing arm 2120. In other embodiments, one or more fixing arms include three fixing arms 2120 arranged symmetrically around the outer circumference of the lens support structure. The fixing arms 2120 may be made of a semi-rigid material or may have a geometric shape that provides sufficient structural rigidity.

[0091] The device 2100 may also include as few as two fixing arms 2120. These fixing arms 2120 may be under equal, opposite tensions when implanted and fixed transscleral. Alternatively, the fixing arms 2120 may be asymmetrical such that one fixing arm 2120 is under tension and the other fixing arm 2120 has stiffness and length that functions as a rigid spacing element. Fixing elements that are rigid or can be subjected to spring force may rely on penetrating or being pressed into place by adjacent tissue. Tensioned fixing elements may rely on slight stretching or expansion of the material after placement. One or both of the fixing arms 2120 may be manufactured in an inwardly biased configuration in which the fixing arm is biased toward a forward-projecting curve or folding configuration, as described elsewhere in this specification. The fixing arms 2120 may have a paddle-like shape that resists rotation when engaged with ocular tissue.

[0092] The apparatus 2100 may also include three or more fixed arms 2120. Three fixed arms 2120 can provide the apparatus 2100 with a defined fixed plane substantially parallel to the Z-plane (vertical plane) of the eye. The fixed arms 2120 can be designed and deployed to have each fixed arm 2120 under equally opposite tension. Alternatively, one or more fixed arms 2120 may have rigidity and length and be designed to act as a rigid spacing element. Zero, one, two, or all three or more fixed arms 2120 can be manufactured in an inwardly biased configuration or can be biased toward the center of the apparatus or the central axis CA of the apparatus (see Figures 11A-11F, 12A-12C, 13A-13E). Inwardly biased fixed arms 2120 may extend from the support structure and have a folded configuration before embedding. As described herein, at least one, but fewer than all, of the fixed arms may be biased or curved. As described herein, at least two, but fewer than all, may be biased or curved. In some embodiments, all of the fixed arms 2120 may be biased or curved. The device may include three fixed arms, two of which are flexible and biased toward a folded configuration, and a third fixed arm which is less flexible than the other two and biased toward an unfolded configuration. Each folded configuration of a fixed arm can bias the end portion of the fixed arm toward the central axis CA of the device. The lens support structure can be biased toward a substantially flat or planar configuration, while the fixed arms are biased toward a folded configuration that is not substantially flat or planar.

[0093] Once embedded and scleral-fixed, the inwardly biased arms can be bent away from the folded inwardly biased configuration or can be unfolded (spread out). In a preferred embodiment, the two fixing arms 2120 have an inward bias shape, and the third fixing arm 2120 has an increased cross-sectional area to increase its rigidity. The inwardly biased fixing arms 2120 can incorporate a bend between the starting point and the end point of the arms having the lens support structure 2105. The two bendable fixing arms 2120 can be biased toward the central axis CA of the device toward the folded configuration.

[0094] In one embodiment, the device 2100 may include at least three fixed arms 2120. When stationary and before embedding, at least one of the three fixed arms may extend from the support structure in an unfolded configuration, and at least two of the three fixed arms may extend from the support structure in a folded configuration. Then, when stationary before embedding, at least one of the three fixed arms may be biased toward the unfolded configuration, and at least two of the three fixed arms may be biased toward the folded configuration. After embedding, each of the arms biased toward the folded configuration may be unfolded.

[0095] Each of the fixing arms 2120 may include a starting portion 2103 of the support structure 2105 and a terminal portion 2102 coupled to a non-traumatic anchor 2125 for sutureless transscleral fixation. Before transscleral fixation of the anchor 2125, one of the multiple fixing arms 2120 (up to all of the fixing arms 2120) may include a curved fixing arm 2120 that curves between its starting portion 2103 and its terminal portion 2102 to form a bend B (see Figures 11A-11F, 12A-12C, 13A-13E), thereby allowing direct visualization of at least a portion of the curved fixing arm 2120 through the pupil 30 of the eye (see Figure 14). After transscleral fixation of the anchor 2125, each of the multiple fixing arms 2120 may have tension applied between its starting portion and terminal portion to align the support structure with respect to the Z-plane of the eye. The support structure 2105 is fitted to support the intraocular lens. The central aperture 2115, which penetrates the entire thickness of the support structure 2105, is fitted to allow light to pass through both the central aperture 2115 and the IOL supported by the support structure 2105. The curved fixing arm 2120 can be curved forward so that a portion of the arm 2120, such as the terminal 2102 and / or its non-traumatic anchor 2125, is positioned above at least a portion of the support structure 2105 (e.g., above the upper surface of the support structure 2105 and / or above the area of ​​the central aperture 2115). Alternatively, the curved fixing arm 2120 can be curved backward so that a portion of the arm 2120, such as the terminal 2102 and / or its non-traumatic anchor 2125, is positioned below at least a portion of the support structure 2105 (e.g., below the lower surface of the support structure 2105 and / or below the area of ​​the central aperture 2115).

[0096] Figures 11A–11F, 12A–12C, and 13A–13E show embodiments of the device 2100 having fixed arms 2120 in a stationary state and before embedding. Two of the three fixed arms 2120 are curved inward so as to be biased toward a folded configuration when stationary. The arms 2120 extend outward substantially perpendicularly from the support structure 2105, such as from their origin 2103 in the support structure 2105, and form a pivot (forward or backward) that forms a curve between the origin 2103 and the end 2102 of the arm 2120. The curvature of the arm 2120 allows the end 2102 of the arm 2120 to be positioned closer to its own origin portion 2103. In some embodiments, the arm 2120 is curved forward such that the end 2102 of the arm 2120 is positioned in front of the starting portion 2103 of the arm, or on at least a portion of the front-facing surface of the support structure 2105 near the starting portion 2103 of the arm. In other embodiments, the arm 2120 can be curved backward such that the end 2102 of the arm 2120 is positioned behind the starting portion 2103 of the arm, or below at least a portion of the rear-facing surface of the support structure 2105 near the starting portion 2103 of the arm. In one embodiment, the anchor 2125 of the curved fixed arm 2120 can be curved away from the first plane of the support structure (e.g., the Z-plane of the eye) to a second plane parallel to the first plane. The second plane can be in front of or behind the first plane, depending on whether the arm 2120 is curved forward or backward. The curvature can be in a direction substantially traversing the plane of the lens support structure 2105 (e.g., the Z-plane) (e.g., the X-plane). The dilated pupil (depending on whether it is an adult or pediatric patient) can have a maximum diameter of about 8 mm. The anchor 2125 of the curved fixing arm 2120 is positioned so that the curvature does not interfere with direct visualization by the opaque iris, for example between about 3 mm and about 7.5 mm, more preferably between about 7 mm, within the diameter of a circle in a second plane visible within the diameter of the dilated pupil.Each anchor 2125 of the curved fixed arm 2120 can be positioned at a certain distance from the center of the device, for example, at a distance of approximately 1.5 mm, 2.0 mm, 2.5 mm, 3.0 mm, up to approximately 3.5 mm, or up to approximately 4.0 mm from the center of the device. The curved arm 2120 positions its ends 2102 and / or anchors 2125 within this diameter or distance from the center of the device, enabling easy visualization. The third of the three fixed arms 2120 is biased to a straight configuration or an unfolded configuration when stationary. The third arm 2120 extends outward at a right angle from its origin 2103 in the support structure 2105 and does not rotate or bend. Rather, the entire third arm 2120 is perfectly straight and extends substantially along a single axis. The two stationary fixed arms, which are biased toward a folded configuration when stationary, are here in an unfolded configuration, for example, by applying tension to arm 2120 via transscleral anchors that are positioned outward.

[0097] It should be understood that even without the fixed arm 2120, or even if the fixed arm 2120 is not biased into a folded configuration when stationary, the device 2100 can be directly seen through the pupil. For example, the device 2100 may incorporate one or more centrally projecting features 2117, such as on an awning 2110 (see Figures 18E-18H or 18I-18J), which can be visualized by the user during implantation. The features 2117 project sufficiently toward the center of the central opening 2115, for example, from at least about 2.5 mm to about 3 mm from the center, thereby being visible through the pupil during the implantation procedure.

[0098] The fixed arms 2120 can be uniformly distributed around the device 2100 to provide uniform tension. Alternatively, the fixed arms 2120 may be oriented in a non-uniform distribution, for example, with three fixed arms 2120 at 90 degrees to each other. In this scenario, two of the fixed arms 2120 are at 180 degrees to each other and provide opposite tension. The third fixed arm 2120 primarily serves to prevent rotation of the device 2100.

[0099] Each fixed arm 2120 may have a spring force that is a function of the material's elongation under load. In contrast, an open-loop tactile part or coil spring may have a spring force that is given by the bending of the material, which has a substantially fixed length. Once fixed to the eye, the fixed arm 2120 may be under tensile stress and material elongation. For example, each fixed arm 2120 may have an extension over a radius of about 7.5 mm to 8.0 mm to accommodate a diameter of about 15 mm to about 16 mm. The device has a range of tensions that is operable for its function. As an example, the device may be under a first amount of tension (X tension) when embedded. The first amount of tension is the amount of tension at the minimum allowable diameter. In other words, the device is under a minimum amount of tension to function, but can be placed under greater tension to accommodate larger diameters. In the example of the fixed arm 2120 that can accommodate elongations of both 15 mm and 16 mm, each force-transmitting arm can operate under a first tension X and at least a second tension. The second tension can be the sum of the first tension X and the tension distance (e.g., 0.5 mm tension). The fixed arm can withstand the available tension difference at each elongation ratio. To illustrate further, if the length of each fixed arm 2120 in this embodiment is approximately 4 mm, the second tension (X tension + 0.5 mm tension) can receive a 12.5% ​​increase in elongation to function at a diameter of 15 mm and up to a diameter of 16 mm. If the length of the fixed arm 2120 in this example is 2 mm, the second tension (X tension + 0.5 mm tension) can receive a 25% increase in elongation to function at a diameter of 15 mm and up to a diameter of 16 mm. If the length of the fixed arm in this embodiment is approximately 6 mm, the second tension (X tension + 0.5 mm tension) can receive a 6.25% increase in elongation to function at a diameter of 15 mm and up to a diameter of 16 mm. Since the tension of the anchor on the ocular tissue does not depend much on variables that are difficult for the surgeon to evaluate, namely the intrinsic dimensions of the eye and the specific location of the incision, reducing the spring force of the fixing arm 2120 can improve the safety and functionality of the device.Furthermore, the length of the fixing arms (e.g., between approximately 2 mm and 6 mm) and the inward curvature (forward or backward) of at least one fixing arm 2120 improve access and visualization for the surgeon to locate and fix the arms during surgery. The device may have a relaxation fixing diameter Dd of approximately 15 mm to approximately 20 mm, preferably approximately 16.50 mm to approximately 18.00 mm, where the radius of the circle is measured from the center of the central opening 2115 to the surface of the straight fixing arm 2120 facing inward at the anchor 2125 (see Figure 18E).

[0100] The end footplate or anchor 2125 of the fixed arm 2120 can be coupled to or positioned at the outer end of the fixed arm 2120. The anchor 2125 can have various shapes designed to be easily removed by the surgeon and to stabilize the tension of the device throughout its service life. The anchor 2125 can generally be thin and can have a geometric shape (e.g., rounded) designed to limit conjunctival erosion and eyelid irritation. The end of the fixed arm 2120 may have an anchor 2125 configured to fix the lens support structure 2105 and to be positioned outside the sclera 20 to prevent centripetal slippage. The shape of the anchor 2125 allows the surgeon to pass the anchor 2125 through a puncture or incision of the sclera 20 using forceps, trocars, snares, or other surgical instruments, including snare devices for anchor extraction as described in U.S. Patent No. 10,973,624, incorporated herein by reference. The anchor 2125 may have a shape resembling a nail head, a T-bar, a multi-branched shape, or any other shape that preferably passes through the sclera 20 in a first direction and can resist pulling out in the insertion direction to maintain its external position when the arm 2120 is placed under expected tension over the service life of the device. The anchor 2125 is designed to have a profile and geometric shape that does not cause irritation to the eyelid or conjunctiva throughout the service life of the device 2100. Therefore, a preferred geometric shape has a minimum thickness profile with a smooth, rounded, and / or tapered edge. The anchor 2125 may have a substantially constant thickness or may have varying thicknesses over its length, as will be described in more detail below.

[0101] The anchor 2125 described herein is configured to be easily externalized and to withstand re-internal migration after externalization. The anchor may be designed to be graspable using ophthalmic instruments (e.g., 23, 25, or 27 gauge). A shape ideal for grasping with ophthalmic instruments may not necessarily be ideal for secure fixation. Figures 16A–16C show additional geometric shapes of the anchor 2125 having variations in thickness, width, and / or height. The anchor 2125 may include a central portion 1255 and one or more graspable portions 1257 surrounding the central portion. The central portion 1255 may be positioned above the wound (scleral incision) into which the anchor 2125 is inserted and above the graspable portions 1257 positioned directly adjacent to the wound. The central portion 1255 may have increased thickness, height, and / or width compared to the surrounding graspable portions 1257. Increasing the thickness, height, and / or width of the central portion 1255 can add bulk to the area over the wound, thereby reducing the likelihood of tension from the fixing arm pulling the anchor 2125 back through the wound. The central portion 1255 of the anchor 2125 may have a thickness Tc along the longitudinal axis L of the arm 2120 that is greater than the thickness Tg of the gripping portion 1257. For example, the thickness Tc can be about 1.2 to 5.0 times the thickness Tg of the gripping portion 1257. In other embodiments, the central portion 1255 may have a width or height about 1.2 to 5.0 times the width or height of the gripping portion 1257. The geometric shape of the bulkier area is designed to resist deformation under tensile forces associated with the normal use of the device. The bulkier central portion 1255 can be folded inward during outwarding so as to overlap the end of the arm 2120 to which it is attached. When arm 2120 is placed under tension, the bulkier central portion 1255 cannot be folded over itself from the end of arm 2120, thereby preventing the outwardly exposed anchor 2125 from being pulled back through the wound.Therefore, although the central portion 1255 is bulky, it can be pulled through the wound in a first direction (outward from the eye), but its bulk prevents it from being pulled through the wound in a second opposite direction (inward towards the eye).

[0102] The gripping portion 1257 may include any of the following shapes, including oval, rectangular, star-shaped patterns, or other shapes or geometric shapes that improve the gripping of the gripping portion 1257 compared to, for example, the central portion 1255. The gripping portion 1257 may have a thin, narrow tab extending from the central portion 1255. Each anchor 2125 may include one, two, three, four, five, six, or more gripping portions 1257 to enable the user to grip the anchor regardless of the shape of the device.

[0103] In some embodiments, each fixing arm 2120 may have multiple anchors 2125. The device 2100 may have three fixing arms 2120, each fixing arm having a first anchor 2125 at its end and a second anchor 2125 positioned inside the first anchor 2125. The second anchor 2125 can further secure the lens support structure 2105 by preventing centrifugal slippage. Alternatively, the second anchor 2125 may be extended outward through the sclera 20 so that the second anchor 2125 also holds the device 2100 in place. Each fixing arm 2120 may include multiple anchors 2125 that can be positioned along the length of the fixing arm 2120. The multiple anchors 2125 may include two, three, four, five, or more anchors 2125 that are evenly spaced along its length. The surgeon may position as many anchors 2125 externally as necessary to center the device 2100. Excess material around the fixing arm 2120 and anchor 2125 closest to the sclera 20 can be removed by trimming or other means. By trimming material such as one or more of the fixing arms 2120 and the anchors 2125 of the arms from the device, on-the-fly customization for the patient's eye becomes possible. In some situations, for example, if the fixing arm 2120 has multiple anchors 2125 that extend out through the sclera, the excess anchors 2125 (and part of the arm 2120) around the anchors 2125 that perform the anchoring function can be removed from the arm 2120. Thus, multiple anchors 2125 for each fixing arm 2120 can allow the surgeon to resize the device 2100 to the patient's eye during surgery. By trimming the outer portion of the fixing arm 2120 that is provided externally via the anchors 2125 and / or sclera, the length of the fixing arm 2120 can be customized or adjusted on-the-fly. The surgeon may also determine that only one of the multiple fixing arms 2120 is needed for a particular implantation procedure. The surgeon may trim any unnecessary arms 2120 before implanting the device in the eye.For example, a surgeon may decide to trim the curved arms before implantation, leaving only the straight arms for tethering to the sclera. In one embodiment, the device 2100 has multiple fixing arms 2120. Once the device 2100 is implanted in the eye and at least some of the fixing arms 2120 are selected to stabilize the device within the eye, one or more of the remaining fixing arms 2120 that were not needed for stabilization may be trimmed from the device 2100 and removed from the eye. Thus, the length and number of fixing arms 2120 of the device 2100 can be customized in real time during the implantation procedure.

[0104] Two anchors 2125 on a single fixed arm 2120 can have different outer dimensions, with the inner anchor 2125 being narrower than the outermost anchor 2125. It should be understood that multiple anchors 2125 on a single fixed arm 2120 can also have the same dimensions, and there is no need to change their size. The anchors 2125 can also have a shape that improves scleral passage in a first direction but impairs scleral passage in a second opposite direction. For example, an anchor 2125 can incorporate a square edge. However, an anchor 2125 can have a square edge on the inward-facing surface and a smooth tapered edge on the outward-facing surface, and these edges help with scleral passage outward.

[0105] The fixed arms 2120, which extend to the wall of the eyeball, may be difficult to operate because they may be obstructed from the field of vision by the peripheral iris 10, limbus, and sclera 20. As previously stated, one or more of the fixed arms 2120 may be biased inward toward a folding configuration so that they can be directly visualized through the pupil (see Figure 14). Each of the fixed arms 2120 initially extends outward orthogonally from the support structure 2105, and then can be curved or folded forward (or backward) so that the end 2102 of the fixed arm 2120 (or at least a portion of the anchor 2125) is positioned over the fixed arm 2120 extending through the support structure 2105, the support structure 2105, or at least a portion of the central opening 2115. At least a portion of the bent fixed arm (i.e., the end and / or anchor 2125) can be more easily visualized through the dilated pupil, and visualization is not obstructed by the opaque iris 10 (see Figure 14). This inward (centripetal) bias also allows the bent fixing arm 2120 to be securely gripped and manipulated during device implantation. Each of the fixing arms 2120 of the device 2100 may have an inward bias toward the folded configuration, or only a selection of the fixing arms 2120 may have an inward bias (e.g., one, two, or fewer fixing arms 2120).

[0106] The fixed arm 2120 can also be molded to incorporate a bent or curved portion between its starting point and the lens support structure 2105 and terminal anchor 2125 (see Figures 11A-11F, 12A-12C, 13A-13E, and 15). A bent fixed arm 2120 can be biased toward a folded configuration. For example, one or more of the fixed arms 2120 can be bent radially and centripetically together with the lens support structure 2105 between 90 and 270 degrees from its starting point. Thus, the end 2102 of the bent fixed arm 2120 lies in a plane different from the plane of the lens support structure 2105. When stationary before being placed in the eye, the end 2120 of at least the first fixed arm 2120 of the multiple fixed arms 2120 can incorporate a bent portion B between its starting point 2103 and the lens support structure, and its end 2102 forms a bent arm. The bending arm can extend from its origin by at least a first distance perpendicular to the lens support structure 2105. The bending arm can then bend upward (forward) by at least another distance from the plane of the lens support structure 2105. The bending arm 2120 can then bend back toward its origin or toward the central axis CA of the device. This can result in the end of the bending arm 2120 being in a plane different from the plane of the lens support structure 2105. The bent or curved portion of the arm 2120 can project outward toward the central axis CA and toward both the origin 2103 and the end 2102 of the arm. The transscleral anchor 2125 and / or the end portion of the fixed arm 2120 can be positioned on or in front of at least a portion of the lens support structure 2105, or on at least a portion of the central opening 2115. Alternatively, the bending arm 2120 can be curved downward (backward) by at least a certain distance from the plane of the lens support structure 2105, and the transscleral anchor 2125 or the end portion of the fixed arm 2120 can be positioned below or behind at least a portion of the lens support structure 2105 and / or below or behind at least a portion of the central opening 2115.The folding configuration (whether the arms 2120 are curved forward or backward) allows at least a portion of the curved fixed arms 2120, such as the ends of the curved fixed arms 2120 and / or their anchors 2125, to be visualized through the pupil and not obstructed by the opaque iris. A single arm 2120, two arms 2120, or all of the fixed arms 2120 can incorporate the curve. Alternatively, none of the fixed arms 2120 can incorporate the curve (see Figures 18I-18J).

[0107] Once the device is positioned and fixed within the eye, the fixing arm 2120 is subjected to tension so that the bent arm is unfolded from this folded configuration and can no longer be bent. The end of the arm 2120 is biased to move the arm 2120 away from this stationary state in the folded configuration, thereby biasing the bent fixing arm into a straight or unfolded configuration.

[0108] The bent portion B of the folding configuration can be a gentle and smooth bend with a radius of curvature, or it can be bent to form one or more distinct angles along the length of the arm 2120. The bent portion can be relatively easily unfolded or positioned in an unfolded configuration without imposing excessive stress on the lens support structure 2105, while being tight enough to avoid excessive forward protrusion. The inwardly biased geometric shape can have a curved portion with a radius of curvature of approximately 0.10 mm to approximately 2.5 mm at the inner curved portion (front side) and a radius of curvature of approximately 0.6 mm to approximately 3.0 mm at the outer curved portion (rear side). In one embodiment, the end of the inwardly biased fixed arm can be spaced away from the lens support structure 2105 to form a gap G (see Figures 13D to 13E). The gap G can be between approximately 0.2 mm and approximately 2.5 mm. In one embodiment, the biased fixed arm 2120 has a geometric shape that curves along its entire 180-degree radius, with a radius of curvature of approximately 0.63 mm on the inner curve and biased inward by approximately 1.13 mm on the outer curve, thereby separating the lens support structure 2105 and the biased fixed arm by approximately 1.25 mm. The starting point of the curve (near the starting point 2103 with the lens support structure 2105) and the ending point of the curve (near the end point 2102 at the transscleral anchor 2125) can have multiple radii so that the curve varies over the length of the fixed arm 2120. The curvature of the biased fixed arm 2120 can have an average curvature of approximately 0.15 mm to approximately 2 mm on the inner curve.

[0109] The bent fixing arm 2120 can be seen through the pupil when it is unstressed (stationary) (see Figure 14) after implantation and before fixation to the scleral wall. This visibility allows the surgeon to easily engage with the anchor 2125. Once the surgeon engages with the fixing arm 2120 by grasping the body of the fixing arm 2120 or anchor 2125, the surgeon can unfold the fixing arm 2120 from its stationary folded configuration so that it is substantially planar with the lens support structure 2105. These fixing arms 2120 can have flexibility such that stress accumulated in the material in the unfolded state does not impart torsional or tensile forces to the lens support structure 2105 in a manner that impairs the function of the device. The fixing arm 2120 can be molded to rotate 90 to 270 degrees tangentially and centripetically from its lens support origin. The fixed arm 2120 may incorporate an elastic material or a deformable hinge to facilitate this operation without substantially altering the geometric shape of the lens support structure 2105. The fixed arm 2120 may have a length such that when the fixed arm 2120 is bent 180 degrees backward toward its origin together with the lens support structure 2105, the end 2102 of the fixed arm 2120 can be positioned over at least a portion of the lens support structure 2105. Each of the fixed arms 2120 of the device 2100 may have a bend, or only a selection of the fixed arms 2120 may have a bend (e.g., one, two, or fewer fixed arms 2120). Figures 11A-11F, 12A-12C, and 13A-13E show that two of the fixed arms 2120 have a bend B, and one of the fixed arms is substantially coplanar with the plane of the lens support structure 2105.

[0110] One or more of the fixing arms 2120 of the apparatus described herein may be manufactured to have a non-planar shape when stationary and may be biased toward a folded configuration that allows at least a portion of the fixing arm 2120 to be easily seen through the pupil after the apparatus 2100 has been implanted but before the anchor 2125 has been externalized. The fixing arm 2120 thus configured can be more easily grasped and manipulated by the user and may be biased toward an expanded configuration for sutureless fixation. Fixing arms 2120 manufactured to have a bias when stationary, or to be curved or bent when stationary, include fixing arms 2120 that have that shape when the apparatus 2100 is outside the eye and ready for implantation. In some embodiments, the fixing arm 2120 may take on a curved, folded, or bent shape after implantation in the eye (e.g., posterior chamber) but before the anchor is fixed. For example, one or more fixed arms 2120 may be formed from a material that has a first shape on the outside of the eye, which is different from the shape of the arm 2120 before implantation into the eye, takes on a curved shape when implanted into the eye, and can unfold into a substantially straight shape when the anchor 2125 is exposed.

[0111] A fixed arm 2120 having a bias toward a folded or curved shape (e.g., having a bend along its length between its origin 2103 and its end 2102) can be visualized through the pupil, grasped, and manually unfolded and / or extended to secure the anchor 2125 of the arm 2120 transscleral. The configuration of the curve, bend, or fold and / or radius of curvature, as well as the orientation of the direction of the curve, bend, or fold, can vary as long as at least a portion of the fixed arm 2120 (e.g., the anchor 2125 and / or the end portion coupled to the anchor 2125) is visible to the user through the diameter of the patient's pupil, preferably the patient's dilated pupil. In some embodiments, this means that at least a portion of the fixed arm 2120 is positioned radially inward of its outer region 2111 over at least a portion of the lens support structure 2105. The distance over which a portion of the arm 2120 extends radially inward of the outer region 2111 can vary. This portion can extend over a position adjacent to the outer region 2111, but not directly above the outer region 2111, in the orientation of the central axis CA extending forward and backward through the central opening 2115. In this embodiment, the distance between the central axis CA of the device and the upward-extending portion is greater than the distance between the central axis CA of the device and the outer region 2111. This portion can extend to cover the outer region 2111. In this embodiment, the distance between the central axis CA of the device and the portion is the same as the distance between the central axis CA of the device and the outer region 2111. This portion can extend over a position radially inward of the outer region 2111. In this embodiment, the distance between the central axis CA of the device and the portion is less than the distance between the central axis CA of the device and the outer region 2111. This portion can extend over the central opening 2115. In this embodiment, the distance between the central axis CA of the device and the portion is less than the distance between the central axis CA of the device and the inner wall 2109 defining the central opening 2115. The central axis CA of the device may be coaxial with the center of the central aperture 2115.

[0112] A portion of the fixed arm (e.g., the terminal 2102 and / or anchor 2125) can be positioned over a portion of the lens support structure 2105 and simultaneously over a portion of the central opening 2115. For example, the anchor 2125 may have dimensions such that at least a portion of the anchor 2125 is positioned over at least a portion of the lens support structure 2105, and another portion of the anchor 2125 is positioned over at least a portion of the central opening 2115.

[0113] A fixed arm 2120 biased toward a curved configuration may curve toward the inside or central portion of the device, including but not limited to the actual center of the device or the central axis CA or the center of the central opening 2115. The center of the device 2100 is the center of the circle formed by the central opening 2115 (if the central opening 2115 is circular). The central axis CA of the device extends in the longitudinal direction (i.e., vertical direction) through the center of that circle. If the central opening 2115 is substantially non-circular, the center of the device is the center of symmetry of the central opening 2115 along the central axis CA extending in the longitudinal direction. A fixed arm biased toward a folded or curved configuration such that the anchor extends toward the center of the device or toward the central axis CA of the device does not require that the axis of the arm passing through the anchor intersects the actual center of the device or the central axis CA. With respect to an inwardly biased fixing arm, "towards the center" or "towards the central axis" includes a curved arm such that the end of the fixing arm extends backward toward a part of the device toward a part of the device toward a straight fixing arm whose end extends toward a part toward a part toward a straight fixing arm whose end extends toward a part toward a straight fixing arm. The curved fixing arm can be biased toward any central part of the device and does not need to point toward the actual center of the device. The curved fixing arm can be angled toward the actual center.

[0114] The apparatus may include at least some fixed arms extending rearward toward the center of the apparatus. Apparatus 2100 may include a lens support structure 2105 and three fixed arms 2120. Two fixed arms 2120a, 2120b may be biased into a folding configuration in which a bend B exists between the origin 2103 and the end 2102 of the arm. A third fixed arm 2120c may be substantially straight and have no bend B between its origin 2103 and its end 2102, thereby the third fixed arm extending substantially perpendicular to the lens support structure 2105 along a single axis L. The anchors 2125 of each fixed arm 2120a, 2120b may project and retract toward the center of the apparatus. The anchors 2125 of the fixed arms 2120a and 2120b may have at least a first portion overlapping with at least a portion of the lens support structure 2105 and / or at least a second portion overlapping with at least a portion of the central opening 2115. An axis can be drawn through the anchors 2125 of each arm 2120a and 2120b, indicating the direction in which the anchors 2125 project toward the center of the device away from the bend B between the arm's origin 2103 and its end 2102. The arm axis may, but does not have to, intersect the central axis CA. Thus, the arms can be biased toward a folding configuration in which the anchors project toward the center of the device and return, but do not have to extend along an axis intersecting the central axis CA or the actual center of the device.

[0115] When a fixed arm is described as having a “folded,” “bent,” or “curved,” or “folding,” “bent,” or “curved” configuration, the angle of the fixed arm with respect to the longitudinal axis along its length may change gradually and uniformly, or it may change more abruptly or sharply so that the angle is formed. A folded configuration may represent an inward bias of the fixed arm when stationary or before implantation, where the fixed arm extends outward from the support structure along a first axis and curves forward and backward with respect to the plane of the support structure to return toward the central portion of the device. When implanted, the support structure of the device is configured to be substantially parallel to the Z-plane (vertical plane) of the eye. A folded configuration may include a shape in which the fixed arm curves away from this plane of the support structure (e.g., in a cross-section) so that at least a portion of the fixed arm is positioned in front of another portion of the device (e.g., the lens support structure and / or central opening) above itself. A folded configuration does not necessarily mean that the portions of the fixed arm overlap and are in contact with each other. Preferably, the fixed arm portions are spaced a certain distance apart from each other, and this distance is along the central axis CA of the device. The folding configuration does not necessarily mean a folded or acute-angled fold. The folding configuration can mean that a radius of curvature exists between the starting point and the ending point of the fixed arm in the support structure.

[0116] The folding configuration may also include fixed arms that curve within the plane of the lens support structure rather than away from it. The anchors 2125 of each fixed arm 2120a, 2120b may project inward from the bend B of the arm so that the anchors 2125 remain substantially in the same plane as the plane of the lens support structure. An axis can be drawn through the anchors 2125 of each bend arm 2120a, 2120b, indicating the direction in which the anchors 2125 project away from the bend B between the arm's origin 2103 and its end 2102 toward the center of the device. Fixed arms 2120a, 2120b biased toward the folding configuration may have anchors 2125 projecting toward the center of the device. The axes of the arms 2120 may, but do not need to, intersect the central axis CA.

[0117] A portion of the arm 2120 positioned over at least a portion of the support structure 2105 may include a portion of its own that is located above and radially inward of the outer region 2111 of the support structure 2105. A portion of the arm 2120 positioned over at least a portion of the support structure 2105 may include a portion of its own that is located radially inward of and over the central opening 2115. In these examples, “radially inward” does not necessarily mean in the same plane. Preferably, a portion of the arm 2120 is positioned over a portion of the support structure in a plane different from the plane of the support structure. A portion of the fixed arm 2120 (e.g., an anchor 2125 and / or termination 2102) may terminate in front of or behind the lens support structure 2105 with a diameter that is central to the outer circumference of the lens support structure 2105. This portion may be positioned over a portion of the lens support structure with respect to the central axis CA of the device extending forward and backward through the central opening 2115. If it is described that a portion of the fixed arm 2120 extends over a portion of the lens support structure, then a portion of the fixed arm 2120 may also extend over the central aperture 2115 defined by the lens support structure 2105.

[0118] Where a portion of arm 2120 is described herein as "overlapping" another portion of device 2100 (e.g., itself, the lens support structure 2105, and / or the central aperture 2115), the portion of arm 2120 can generally overlap that portion of the device in space and does not require a specific orientation relative to the retina. Thus, "overlapping" may generally be used herein to refer to overlapping in the space surrounding the device and does not require the spatial overlap to be substantially forward relative to the retina. The portion described as "overlapping" another portion can be positioned behind the retina during use. Arm 2120, when biased into a folded configuration, can be described herein only as "overlapping" or "overlapping" another portion of the device, even if it is positioned "below" or "behind" another portion of the device relative to the retina during use. For simplicity, each alternative does not have to be repeated in each example throughout this disclosure. The arm can be curved so that at least a portion of the arm is positioned over the front-facing portion of the device such that at least a portion of the arm is roughly arched above the device along the central axis CA. The arm can be curved so that at least a portion of the arm is positioned over the rear-facing portion of the device such that at least a portion of the arm is roughly arched below the device along the central axis CA. The arm can be curved so that at least a portion of the arm is positioned in the same plane, thereby the arm does not extend over the front-facing portion or over the rear-facing portion of the device. In this specification, any of the various configurations of the fixed arm are considered such that at least a portion of the arm is visible through the dilated pupil. The mechanism can be modified so that the bent fixed arm 2120, biased toward a folded configuration, unfolds to take on a straight configuration. The arm can be unfolded mechanically, electromagnetically, and / or thermally.

[0119] In some embodiments, the fixed arm 2120 may be mechanically unfolded along a single axis of the arm. The fixed arm 2120 does not need to be biased into a folding configuration having a bend or curving portion when stationary. For example, the fixed arm 2120 may be biased into a folding configuration in which the arm 2120 is compressed longitudinally along a single axis. The arm 2120 extends outward along a single axis perpendicular to the lens support structure between its origin portion 2103 and its end portion 2102. The length of the arm 2120 in the folding configuration can be shortened between the origin portion 2103 and the end portion 2102 so that the anchor 2125 of the arm 2120 is positioned more centrally within a smaller diameter than in the unfolded configuration. Once the device is implanted in the eye, but before the anchor 2125 is externalized, the arm 2120 may be extended outward to extend its length so that it can be externalized. Mechanical deployment by extension or retraction may result from the sliding of the nesting components of the arm 2120 toward each other, giving it a longer length when deployed or a shorter length when folded. Nesting mechanical deployment may also result from a single elastic component configured to fold into itself at a shorter length for visualization through the pupil and to unfold from itself at a longer length during outward projection.

[0120] In some embodiments, the fixed arm 2120 may be thermally unfolded or folded. For example, the fixed arm 2120 may be in a first (folded or straight) shape at room temperature and change to a second shape at or near body temperature (heated to 35°C). This can also be achieved by chemical means (e.g., hydration) or mechanical means (cutting limiting features).

[0121] The fixing arm 2120 can be manufactured from an elastic or inelastic material. For example, the fixing arm 2120 can be formed from an inelastic material and may have a three-dimensional shape that imparts elasticity. The three-dimensional shape may vary as described elsewhere in this specification, including C-shapes, Z-shapes, S-shapes, or other three-dimensional shapes. The fixing arm 2120 provides sufficient support to hold the IOL 110 or other device without applying excessive force to the scleral tissue. The optimal design has a wide range of tension and stability so as to be able to meet the parameters of both eyes of varying sizes and incisions of various locations. One means of modifying the morphology of the fixing arm is to incorporate a spring-like structure. These may include conventional compression-based tactile morphologies such as J-loops, C-loops, closed-loops, Kellman haptics, plate haptics, or other tactile morphologies common to IOLs. Alternatively, the device 2100 may incorporate tension-based haptics such as a simple linear elastic cord. Alternatively, the tension configuration can be modified by V-shaped, Z-shaped, or S-shaped features to reduce the tensile resistance of the fixed arm 2120.

[0122] The fixing arm 2120 may have a texture or feature that allows it to be pulled in one direction through the sclera, but resists in the opposite direction to minimize the possibility of the fixing arm 2120 slipping. The texture or feature may be provided by the material itself or designed within the fixing arm 2120. For example, the fixing arm 2120 may be barbed and formed from a material incorporated into the outer structure. In this way, the barbed internal structure can function as a barbed while concealing the sharp edges generally associated with the barbed. One example is a rigid plastic structure embedded in a soft elastomer structure.

[0123] The fixed arm 2120 can be formed from a flexible material that has memory and is not malleable. Flexible materials for the fixed arm 2120 include polyurethane, hydrophobic acrylic, hydrophilic acrylic, nylon, polyimide, PVDF, natural polyisoprene, cis-1,4-polyisoprene natural rubber (NR), trans-1,4-polyisoprene gutta-percha, synthetic polyisoprene (IR of isoprene rubber), polybutadiene (BR of butadiene rubber) chloroprene rubber (CR), polychloroprene, neoprene, and biprene. Various elastomers including, butyl rubber (isobutylene and isoprene copolymer, IIR), halogenated butyl rubber (chlorobutyl rubber: CIIR, bromobutyl rubber: BIIR), styrene-butadiene rubber (styrene and butadiene copolymer, SBR), Buna N rubber, hydrogenated nitrile rubber (HNBR), nitrile rubber (butadiene and acrylonitrile copolymer, NBR), also called Thermon and Zetpol, EPM (ethylene propylene rubber, copolymer of ethylene and propylene) and EPDM rubber (ethylene propylene diene rubber, terpolymer of ethylene, propylene and diene component), epichlorohydrin rubber (ECO), polyacrylic rubber (ACM, ABR), silicone rubber (SI, Q, VMQ), fluorosilicone Examples include rubber (FVMQ), fluoroelastomers (FKM, FEPM), Viton, Technoflon, Fluorel, Aflas and Dyer, perfluoroelastomer (FFKM), Technoflon PFR, Karles, Chemraz, Perast, polyetherblock amide (PEBA), chlorosulfonated polyethylene (CSM), (Hypalon), ethylene vinyl acetate (EVA), thermoplastic elastomer (TPE), resins and elastins, polysulfide rubber and elastoolefin.

[0124] The arms 2120, made of a flexible material formed into a shape, can bend away from the formed shape but have memory to return to the formed shape. In other words, the flexible fixed arms 2120 can be bent or unfolded from their folded configuration but cannot be biased into different shapes that are held without any kind of fixation. For example, one or more of the flexible fixed arms 2120 can be formed into a bent shape. For example, an arm may include a 180-degree bend or curve from its starting point 2103, which has a support structure 2105, to its end point 2102 near the anchor 2125. The arm 2120 can maintain this bent shape when the device is stationary and no force is applied to the arm 2120 so that the arm 2120 is biased toward a folded configuration. That is, the arm 2120 is bent when it is not biased. The bent fixed arm 2120 can be bent from its bent shape to a straight shape or unfolded configuration such that the entire arm 2120 extends and is positioned straight with respect to the longitudinal axis L. Once the arm 2120 is bent to a straight shape, it is biased to return to its bent shape or folded configuration. When the bending force on the fixed arm 2120 is released, the arm 2120 returns to its static bent shape. However, during use, the fixed arm 2120 is fixed transsclerally, and the anchor 2125 is fixed to the end 2102 of the arm 2120 located outside the sclera. The arm 2120 is subjected to tension to maintain its straight shape.

[0125] In other embodiments, the fixing arm 2120 may be formed from or incorporated from a malleable material so that the fixing arm 2120 can be bent or formed into a particular shape. The malleable fixing arm 2120 may be formed from materials such as implant-grade metals or plastics including gold, silver, platinum, stainless steel, nitinol, nickel, titanium, polypropylene, polyethylene, nylon, PVDF, polyimide, acetal, and PEEK. The material of the fixing arm 2120 is configured to be cut and removed from the device 2100 during the implantation procedure, as described elsewhere in this specification.

[0126] One or more fixing arms 2120 may have a Young's modulus of less than approximately 1000 MPa, or less than approximately 500 MPa, or less than approximately 250 MPa, or less than approximately 100 MPa, or less than approximately 50 MPa, or less than approximately 25 MPa. One or more fixing arms 2120 may have a Young's modulus of less than approximately 20 MPa, for example, about 0.01 to about 1.0 MPa. The fixing arms 2120 are designed to be under tension to fix the support structure 2105, rather than having a more rigid penetrating force that can be provided by a compressive spring force or barb or other fixing tactile part to fix the support structure 2105, and therefore are very soft and can be subjected to very small forces.

[0127] In some embodiments, each fixing arm 2120 may have a length between a starting point 2103 and an ending point 2102 that is approximately 2 mm to approximately 6 mm. Each fixing arm 2120 may have the same length. The length of the fixing arm 2120 extending through the sclera may have a thickness or width that is minimized to reduce the overall size of the wound through which the arm 2120 extends. The maximum width of the transscleral portion of the fixing arm near the ending point 2120 where the anchor 2125 is placed may be approximately 2.0 mm or less, approximately 1.5 mm or less, approximately 1.0 mm or less, 0.75 mm or less, or 0.50 mm or less.

[0128] Figures 11A-11F, 12A-12C, and 13A-13E show embodiments of the device 2100 having two fixed arms 2120a and 2120b with an inward bias, and a third fixed arm 2120c that is linear and does not have an inward bias. Furthermore, the third fixed arm 2120c may have a shape that is less flexible than the other fixed arms 2120a and 2120b. The third fixed arm 2120c may have a wider and higher cross-sectional area than the other two fixed arms 2120a and 2120b, and may incorporate a region between the starting point 2103 and the ending point 2102. Figures 16A-16C and 17 show the wider region of the fixed arm 2120. Figure 16B shows that the width W1 of arm 2120 near the end 2102 can be smaller than the width W2 of arm 2120 further away from the end 2102. The width W2 of arm 2120 further away from the end 2102 can provide a certain degree of bulk and stability, while the width W1 near the end 2102 can minimize the transscleral portion of arm 2120.

[0129] Each of the fixing arms 2120a, 2120b, and 2120c can be positioned one at a time during the surgical procedure. As described elsewhere in this specification, the anterior fixing arm 2120c can be in a straight configuration, while the posterior fixing arms 2120a and 2120b can be curved. The weight of the device can be bent after the anterior fixing arm 2120c is externalized or initially implanted so that the device 2100 tilts posteriorly toward the retina. In this scenario, the surgeon can position the device in a more posterior position. However, this may increase the risk of intraoperative tissue damage due to manipulation of the instrument near the retina. In some embodiments, the anterior fixing arm 2120c can be mechanically and / or geometrically reinforced to reduce the possibility of posterior drift. The anterior fixing arm 2120c can be manufactured from a material that can withstand such deformation. The material can be any implant-grade plastic or metal that can cantilever support the device after the anchor 2125 of the anterior fixing arm 2120c is externalized. Suitable materials include, but are not limited to, PMMA, rigid silicone, nylon, hydrophilic and hydrophobic acrylics, PEEK, polyimide, stainless steel, titanium, and nitinol. A more rigid material can be used to form the entire front fixing arm 2120c or only a portion of the front fixing arm 2120c. The front fixing arm 2120c may be formed of a softer material embedded in a more rigid material. In one embodiment, the front fixing arm 2120c may include a region of mechanical reinforcement 1205 between its origin 2103 in the support structure 2105 and its end 2102 coupled to the anchor 2125 (see Figure 17). Region 1205 can be achieved by increasing the thickness of the fixing arm 2120c or by embedding a rigid portion of the plastic in a softer material. Figure 17 shows the increased thickness (arrow T) in the mechanical reinforcement region 1205 compared to the thickness of the arm near its origin 2103 with the support structure (arrow O). Region 1205 can be positioned at a distance from the support 2105, for example, near the anchor or adjacent to the anchor 2125.Region 1205 may have increased thickness designed to particularly reduce the possibility of the device 2100 drifting backward without affecting its ability to expose the anchor 2125 of the fixing arm 2120 to the outside. For example, the fixing arm 2120 may have a tapered thickness designed to limit backward deflection. The tapered shape may be thinnest near the footplate anchor 2125 and thicker in the center. The posterior surface of the fixation may function to bias the device forward relative to the eye. The contact angle between the posterior surface of the fixing arm 2120 and the wound may bias the device 2100 to reduce the practical risk of backward deflection of the fixing arm 2120. Further bulk may further limit the deflection of the device and its proximity to the retina.

[0130] Figures 12A–12C show another embodiment of the device 2100 having a circular central opening 2115 and a non-circular outer perimeter 2111. The non-circular outer perimeter 2111 in Figures 12A–12C is a rounded rectangular shape having two substantially flat elongated sides 2108 and two substantially rounded short sides or lobes 2107. The recesses 2104 formed by the awning 2110 may project onto the front-facing surface of the lens support structure 2105 so that they are positioned substantially opposite to each other along the long axis of the rectangle and spaced apart to accommodate the span of the IOL 110 tactile section 114. For example, the awning 2110 can project onto the front-facing surface of the lens support structure 2105 on the shorter side of a rounded rectangle (i.e., at the position of the lobe 2107), and accommodate the span of the IOL 110 between them in the recess 2104 along the longer side 2108 (see Figure 12C).

[0131] Three fixed arms 2120 can be coupled to the lens support structure 2105. At least one of the fixed arms 2120a, 2120b can be biased into a folded configuration as described elsewhere in this specification. One fixed arm 2120c can be a forward fixed arm extending along a single axis perpendicular to the lens support structure 2105, such that its end 2102 coupled to the anchor 2125 protrudes outward from the central axis CA of the opening 2115. The forward fixed arm 2120c can be coupled to the lens support structure 2105 at the position of the lobe 2107, while the other fixed arms 2120a, 2120b can be coupled away from the lobe 2107 of the forward fixed arm, for example on the opposite elongated side 2108, such that the opposite lobe 2107 protrudes outward between the arms 2120a, 2120b (see Figures 12A-12B).

[0132] Figure 15 shows related embodiments of the device 2100 having an awning 2110. The device 2100 further incorporates a number of bumpers 2114 to assist in centering the device 2100 within the eye. The device 2100 may include four bumpers 2114 projecting outward from each corner of the lens support structure 2105. The bumpers 2114 may be substantially ring-shaped or incomplete rings having a C-shape. Ring-shaped bumpers 2114 may both include a first end and a second end coupled to the lens support structure 2105. C-shaped bumpers 2114 may have one end coupled to the lens support structure 2105 and a second end remaining separate from the lens support structure 2105. Regardless of shape or configuration, the bumpers 2114 can bias the device 2100 away from adjacent ocular tissue. In some embodiments, the bumpers 2114 may deform slightly upon contact with the ciliary structure. The deformation may be temporary, allowing the bumpers to return to their original shapes and push the device 2100 toward its central position within the eye. As with other embodiments described herein, the device 2100 may include a plurality of fixing arms 2120, at least one of which is biased into a folded configuration. Preferably, the bumpers 2114 avoid remaining in contact with the ciliary structure after the device 2100 is embedded. The bumpers 2114 can act as guides during the outward expansion of the fixing arms 2120. The bumpers 2114 can protrude sufficiently from the outer periphery 2111 of the lens support structure 2105 so that the bumpers 2114 abut within the ciliary body 15 and / or ciliary groove 25 to prevent displacement in the Z-plane and maintain proper alignment of the central aperture 2115 with respect to the visual axis of the eye during fixation.

[0133] This specification describes various embodiments of devices implanted in the eye and configured to support, stabilize, or otherwise engage a separate IOL so that the IOL is maintained in optical alignment. The devices described herein can incorporate any of the various feature components in any reasonable combination. For example, the devices in Figures 1A-1F, 2A-2B, 3, and 4A-4B are described in the context of incorporating one or more bumpers 2114, and the devices may, in addition to or instead, incorporate one or more fixed arms 2120 and / or rear stabilizing feature components 2138. Here, the devices in Figures 5A-5C are described in the context of having a rear stabilizing feature component 2138, and may, in addition to or instead, incorporate one or more fixed arms 2120 and / or bumpers 2114. The devices shown in Figures 6A–6E and Figures 8A–8F and 9A–9B are also described in the context of having both a bumper 2114 and a rear stabilizing feature 2138, which can additionally or alternatively incorporate one or more fixed arms 2120. The same applies to the devices shown in Figures 10A–10D, as well as those shown in Figures 11A–11F, 12A–12C, 13A–13E, 15, and 17. Any combination of the feature components described herein can be combined with the device in any of several combinations to address a variety of functional purposes.

[0134] Figure 18A shows an interrelated embodiment of the device 2100, which includes a rear platform 2105 and an awning 2110 that forms a rectangular chassis. The chassis has a front end 2101 and a tapered rear end 2106. The rear end 2106 of the chassis between the rear fixing arms 2120a and 2120b may be narrower than the width of the front end 2101 of the chassis near the front fixing arm 2120c. The rear end 2106 of the chassis can be at least about 0.2 mm, about 0.3 mm, about 0.4 mm, about 0.5 mm, about 1.0 mm, about 1.5 mm, and about 2.0 mm narrower than the width of the front end 2101 of the chassis.

[0135] Figures 18B to 18C show a top view and a perspective view, respectively, of the device 2100 of Figure 18A, which incorporates multiple fixed arms 2120 (one or more of which may be biased into a folded configuration) further incorporating the rear stabilization feature section 2138. Figure 18D shows the device of Figures 18B to 18C, which incorporates the rear stabilization feature section 2138 further incorporating multiple fixed arms 2120 (one or more of which may be biased into a folded configuration) and multiple bumpers 2114.

[0136] The fixed arm 2120, once fixed to the eye, can apply forces to the device that could damage the optical elements of the IOL positioned relative to the device. For example, the rear platform 2105, the awning 2110, the side wall 2112, or other parts of the device 2100, particularly the parts forming the housing for the IOL, may be distorted in response to the tension of the fixed arm 2120. This distortion of the device can be transmitted to the IOL and adversely affect its optical elements. The device described herein may incorporate one or more feature parts designed to resist distortion caused by forces applied to the device, whether resulting from the tension of the fixed arm 2120 or from forces applied to the device 2100 by the eye.

[0137] As previously described with respect to Figures 20A to 20D, the device can incorporate reinforcing material to increase hoop strength and resist strain, which may or may not increase the material thickness of the areas of the device to be reinforced. The hoop strength can also be increased with or without additional reinforcing material by increasing the material thickness of one or more areas of the device 2100. Figures 18E to 18H show embodiments of the device 2100 incorporating multiple fixed arms 2120. The rear platform 2105 and side walls 2112 are reinforced by increasing the material thickness of these areas of the device. Figure 18F is a cross-sectional view of the device 2100 of Figure 18E along arrow FF, showing the increased cross-sectional thickness of the rear platform 2105 (e.g., about 0.50 mm) and the increased thickness of the side walls 2112 (e.g., from about 0.35 mm to about 0.60 mm, or up to about 1.5 mm). The increased rigidity of the lens support structure resulting from the increased material thickness can facilitate the insertion of the IOL after implantation. Increasing the thickness of the material can further increase the hoop strength of the central opening 2115 extending through the rear platform 2105, thereby limiting the risk of the IOL mistakenly passing through the opening 2115 when the IOL is embedded in the device 2100.

[0138] The diameter Da of the central opening 2115 can also be reduced to increase the hoop strength of the posterior platform 2105. For example, the central opening 2115 can have a diameter from less than about 5.0 mm to about 4.0 mm, preferably up to about 4.75 mm, so as not to interfere with the optical elements of the IOL. The opening size, alone or in combination with the thickness of the posterior platform and / or the side wall thickness, can resist the distortion of the device that may be caused by the tensioned fixing arm. The opening diameter can also limit the risk of the IOL passing through the opening 2115 during implantation, not only due to its size but also due to the increased hoop strength of the opening 2115. Smaller opening diameters can increase hoop strength compared to larger opening diameters. A more rigid IOL housing limits the distortion of the opening 2115 when placed under tension and / or compression. Increased rigidity of the IOL housing can also facilitate easier insertion of the IOL after intraocular fixation.

[0139] A thicker side wall 2112 of the apparatus can reduce the space through which the IOL can be manipulated. To provide more space for IOL manipulation within the recess 2104, the external length along the long axis of the apparatus can be increased to accommodate the thicker side wall 2112 and the internal length of the recess along the same axis for IOL insertion and manipulation (see Figure 18G). The rear platform 2105 along the long axis of the apparatus can have an external length Le of approximately 9.2 mm and an internal length Li along the same axis of approximately 8.5 mm, such that the side wall thickness is approximately 0.7 mm. To provide additional reinforcement to the apparatus 2100, the side wall cross-sectional thickness can be increased to approximately 1.2 mm. The platform along the long axis can be increased to approximately 11 mm, such that the internal length Li along the same axis is approximately 9.8 mm. The increased cavity length, combined with the increased side wall thickness, can provide more space through which the IOL can be manipulated, resulting in an increased external length Le of the apparatus. Longer devices can be fixed through the ciliary flattening posterior to the ciliary apex, so that even if the device on the plane of the ciliary apex is too wide, there may still be space to embed a larger IOL housing (see Figure 18H). The minor axis width may also be affected by thicker sidewalls 2112 (see Figure 18F). The posterior platform 2105 along the minor axis of the device can have an external width We of approximately 6.60 mm and an internal width Wi along the same axis of approximately 6.60 mm, such that the thickness of the sidewalls 2112 is approximately 0.7 mm. The cross-sectional thickness of the sidewalls 2112 can be increased to 1.2 mm as described above. The platform 2105 along the minor axis can be increased to approximately 7.4 mm, such that the internal width Wi along the same axis is approximately 6.2 mm.

[0140] The devices described herein are used to support an intraocular IOL. The devices described herein may incorporate one or more feature components configured to engage with at least a portion of the lens capsule for centering or fixing the device in the eye. The devices described herein may also incorporate one or more feature components configured to fix and center the device in the eye even when the lens capsule support is missing, for example, due to iatrogenically impaired lens support as a late complication of surgery or a previous surgery. Visualization of the device during implantation is important, with or without lens capsule support. In some embodiments, a curved or biased fixing arm 2120 can be used to allow direct visualization of the device through the pupil so that the arm 2120 can be more easily grasped, which is particularly useful during externalization and fixation of the device in the eye. The devices described herein can be viewed directly through the pupil even without a fixing arm 2120. In some embodiments, the anterior shape of the device 2100 is modified to improve anterior visualization through the pupil. For example, the forward awning 2110 can be sized and shaped such that at least a portion of it protrudes inward or more centrally (for example, toward a central axis extending through the central opening 2115) than another portion, so that the central protruding portion of the awning 2110 is visible forward through the dilated pupil without being substantially obstructed by the iris. The shape of the awning 2110 can be seen relative to the implanted IOL without affecting the optical elements of the IOL. This can increase the likelihood that the IOL will be properly secured within the recess 2104 of the device 2100. Postoperative lens dislocation can occur when the tactile portion of the IOL remains in an anterior position relative to the device 2100. Uncertainty about the position of the lens can increase surgical time and the possibility of tissue trauma when the surgeon manipulates the device and / or tissue to confirm the position of the lens relative to the device. Direct visualization of the device 2100 through the pupil reduces this uncertainty, especially if the intraoperative pupil diameter decreases during surgery.

[0141] Figures 18E and 18I-18J also show an example of a front awning 2110 having a centrally projecting visualization feature section 2117. The visualization feature section 2117 can project centrally to allow direct visualization of the device 2100 while avoiding interference with the optical elements of the implanted IOL. The visualization feature section 2117 can project sufficiently toward the central axis of the central opening 2115, for example, at least about 2.5 mm to about 3 mm away from the central axis, so that the feature section 2117 is visible through the pupil during the implantation procedure. The centrally projecting visualization feature section 2117 can narrow the internal dimensions of the front opening 2127, for example, the distance Dl of the front opening 2127 along the long axis of the device (see Figures 18H and 18G), but the overall dimensions of the front opening 2127 remain relatively large to access the internal recess 2104. The distance Dl along the long axis of the device between the central edges of the front opening 2127 formed by the visual feature sections 2117 of the opposing awnings can be at least about 7.0 mm to about 5.0 mm, preferably about 6.0 mm. This distance Dl is selected to be greater than the diameter Da of the central opening 2115. For example, the diameter Da of the central opening 2115 can be about 4.75 mm, and the distance Dl between the visual feature sections 2117 can be about 5.00 mm, about 5.25 mm, about 5.50 mm, about 5.75 mm, about 6.00 mm to about 7.00 mm. Thus, even if the awning 2110 incorporates one or more visual feature sections 2117, the dimensions of the front opening 2127 defined by the feature sections 2117 can be greater than the diameter Da of the central opening 2115.

[0142] The feature section 2117 shown in Figure 18E protrudes centrally away from the front fixed arm 2120c, and as a result, the coverage provided by the awning 2110 near this arm is greater than the coverage provided by the awning 2110 near the corner of the device 2100 where the short side 2107 intersects the long side 2108. Therefore, a pair of feature sections 2117 can be positioned on the short side 2107 of the device and protrude along the long axis. Alternatively, the visualization feature section 2117 can be positioned on the long side 2108 of the device and protrude along the short axis (i.e., rotated 90 degrees relative to what is shown in the figure). The visualization feature section 2117 can be positioned anywhere around the anterior region of the device, as long as it extends sufficiently inward to be visible from behind the iris fringes when the device is placed in the eye. The individual visualization feature section 2117 avoids narrowing the front opening 2127 around its entire circumference, providing forward visualization without significantly impairing the user's ability to position the IOL through the front opening 2127 in the front recess 2104 of the platform 2105.

[0143] One or more components of the apparatus described herein may also incorporate visual markers to guide the positioning of the IOL 110 relative to the apparatus 2100. For example, one or more markers may be placed on the rear platform 2105, the front-facing surface of the apparatus, the awning 2110, the side wall 2112, or another part of the apparatus 2100. The markers can assist in the alignment and implantation of the annular lens relative to the apparatus 2100. The markers can enable intraoperative evaluation of the position of the apparatus and / or the IOL 110 relative to the apparatus 2100. One or more components of the apparatus 2100 may be formed of a material such as silicone that is not clearly visible during evaluation using imaging techniques such as UBM. One or more visible markers can help evaluate the position of the apparatus because the markers can be formed of a visible material. The markers can help ensure that the correct plane of the apparatus is achieved before implantation of the IOL 110. The markers can help inform the operator of the relative position of the IOL 110 in order to achieve proper orientation. In some embodiments, one or more markers can be used to align the annular IOL 110 with respect to the device 2100.

[0144] The device described herein can be inserted through a corneal or scleral incision using forceps or other common ophthalmic instruments. Alternatively, the device can be inserted using a syringe system similar to that of an intraocular lens syringe. The syringe allows the device to be unfolded so that a portion of the device is presented sequentially to the surgeon. Alternatively, the syringe can present the complete device into the anterior or posterior chamber in a configuration that limits the risk of surgical error. For example, the syringe can be configured so that the device is inserted "superiorly on the right side". Furthermore, the syringe can limit the risk of damage to the iris, endothelium, capsule, or ciliary zonule during implantation. The IOL 110 can be placed in the device 2100 before or after implantation into the eye. Similarly, the IOL 110 may be removed from the device 2100 and replaced postoperatively.

[0145] The IOL110 can be positioned relative to the device 2100 so that it is securely fixed for proper orientation and optics. Despite being securely fixed to the device 2100, the IOL110 is retrievalable from the device 2100. This allows the IOL110 to be removed and replaced with another after the device 2100 has been implanted. Some patients may receive the IOL110 during the implantation procedure, which has been found to have incorrect force for proper vision. Other patients may receive a multifocal lens IOL110 and later find that the visual quality is insufficient. Furthermore, a patient's refraction may continue to drift over time. In any of these scenarios, the patient may desire a new IOL. In standard cases, IOL replacement is virtually impossible because many IOLs are inserted into the lens capsule, which undergoes pericapsular fibrosis around the lens. The device 2100 allows for easy and simple replacement of an already implanted IOL110.

[0146] Suitable materials or combinations of materials for the preparation of various components of the apparatus disclosed herein are provided throughout. It should be understood that other suitable materials may be considered. The apparatus can be constructed from any implant-grade material that can provide the necessary functions for the side walls, rear platform, bumper or stabilizing features, and / or tether. Materials that may be used in this apparatus may be, but are not limited to, silicone elastomers, fluorosilicone elastomers, polyurethanes, hydrophilic or hydrophobic acrylics, polyolefins, nylons, PVDFs, PMMAs, polyimides, nitinols, titanium, stainless steels, or other implant-grade materials. The apparatus may be made from combinations of materials that are geometrically mated to one another, chemically bonded or welded to one another, overmolded, encapsulated, or other means for joining multiple materials. A given apparatus element may be made from multiple materials. One or more components may consist of inelastic or semi-rigid materials common in ophthalmic applications, such as polypropylene, nylon, PVDF, polyimides, PMMAs, polyurethanes, hydrophilic or hydrophobic acrylics, or high-durometer silicones. One or more components may incorporate or be formed from elastic materials such as acrylic, polyurethane, silicone elastomer, or copolymers thereof to facilitate manipulation during implantation. In yet another embodiment, one or more components may be formed from semi-rigid or rigid plastic materials such as polypropylene, nylon, PVDF, polyimide, PMMA, polyurethane, hydrophilic or hydrophobic acrylic, or high-durometer silicone embedded or coated with soft elastomer materials such as acrylic, polyurethane, silicone elastomer, or copolymers thereof. Additional materials may include PEG, HEMA, NVP, collagen, or other hydrophilic biocompatible coatings, nylon, polypropylene, Gore-Tex, PVDF, Teflon, Nitinol, stainless steel, silver, or gold for mechanical reinforcement and / or improved visualization. One or more components of the apparatus may be formed as separate components bonded together by any of a variety of suitable methods.Alternatively, one or more components of the apparatus may be formed as a monolithic or single element by means of injection molding or compression molding, etc., to give a relatively seamless and uninterrupted surface. Various combinations of materials are considered herein.

[0147] In various implementations, the description is made in conjunction with the drawings. However, a particular implementation may be carried out without one or more of these particular details, or in combination with other known methods and configurations. The description includes numerous specific details, such as specific forms, dimensions, and processes, to give a complete understanding of the implementation. In other examples, well-known processes and manufacturing techniques are not described in particular detail so as not to unnecessarily obscure the description. Throughout this specification, references to “one embodiment,” “one example,” “one embodiment,” and so on mean that the particular feature, structure, form, or characteristic described is included in at least one embodiment or implementation. Therefore, the appearance of phrases such as “one embodiment,” “one example,” and so on in various places throughout this specification does not necessarily refer to the same embodiment or configuration. Furthermore, a particular feature, structure, form, or characteristic may be combined in any suitable manner in one or more implementations.

[0148] The devices and systems described herein may incorporate any of the various features. An element or feature of one embodiment of the devices and systems described herein may be incorporated alternatively, or in combination with an element or feature of another embodiment of the devices and systems described herein. For brevity, various combinations are considered herein, but explicit descriptions of each of these combinations may be omitted. Furthermore, the devices and systems described herein can be placed in the eye and do not need to be implanted as shown in the figures or specifically as described herein. Various devices may be implanted, positioned, and adjusted according to various different methods and using various different devices and systems. Various devices may be adjusted at any time before, during, and after implantation. Several representative descriptions of how various devices may be implanted and positioned are given, but for brevity, explicit descriptions of each method for each implant or system may be omitted.

[0149] Throughout this description, the use of relative terms may indicate, and is not intended to limit, relative position, direction, or orientation. For example, “distal” may indicate a first direction away from a reference point. Similarly, “proximal” may indicate a position in a second direction opposite to the first direction. The use of terms such as “upper,” “lower,” “top,” “bottom,” “front,” “side,” and “back,” as well as “anterior,” “posterior,” “caudal,” and “cephalad,” or their use to establish a relative reference frame, is not intended to limit the use or orientation of any of the devices described herein in various embodiments.

[0150] The word "approximately" means a range of values ​​that includes a specified value, which a person skilled in the art would reasonably consider to be similar to the specified value. In embodiments, approximately means within a standard deviation using measurements generally accepted in the art. In embodiments, approximately means a range of + / - 10% of the specified value. In embodiments, approximately includes the specified value.

[0151] This specification contains many details, but these should not be interpreted as limitations on the scope of what is or may be described in the claims, but rather as descriptions of features specific to particular embodiments. Certain features described in this specification in relation to separate embodiments may also be implemented in combination in a single embodiment. Conversely, various features described in relation to a single embodiment may also be implemented separately or in any suitable partial combination in multiple embodiments. Furthermore, features may be described above as acting in a particular combination and may even be initially described in the claims as such, but one or more features from a combination described in the claims may, in some cases, be cut from the combination, and the combination described in the claims may be directed to a partial combination or a variation of a partial combination. Similarly, although operations are shown in the drawings in a particular order, this should not be understood as requiring that such operations be performed in a particular order or sequential order shown, or that all shown operations be performed, in order to achieve a desired result. Only a few examples and implementations are disclosed. Variations, modifications, and enhancements to the described examples and implementations, as well as other implementations, may be made based on those disclosed.

[0152] In the above description and claims, phrases such as "at least one of..." or "one or more of..." may appear, followed by a conjunctive list of elements or features. The term "and / or" may also appear in lists of two or more elements or features. Such phrases are intended to mean any of the enumerated elements or features individually, or any of the enumerated elements or features in combination with any of the other enumerated elements or features, unless implicitly or explicitly contradicted by the context in which they are used. For example, the phrases "at least one of A and B," "one or more of A and B," and "A and / or B" are intended to mean "A alone, B alone, or A and B together," respectively. The same interpretation is intended for lists containing 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 intended to mean "A alone, B alone, C alone, A and B, A and C, B and C, or A, B, and C," respectively.

[0153] The use of the term “based on” in the foregoing and in the claims is intended to mean “at least partially based,” so as to allow for features or elements not enumerated.

[0154] P Embodiment

[0155] P Embodiment 1. An implantable device for supporting an intraocular lens in an eye having an anterior portion of the lens capsule, comprising: a posterior platform having an inner wall that at least partially defines a central opening, such that light passes through the central opening toward the retina when the device is implanted in the posterior chamber of the eye; and at least one awning, positioned across a front-facing surface of the posterior platform, forming at least one recess between the awning and the posterior platform, wherein the device is configured to be deployed in the posterior chamber without transscleral fixation of the device.

[0156] P Embodiment 2. The apparatus of P Embodiment 1, wherein at least one awning is configured to mate with the periphery of the intraocular lens or with one or more tactile portions of the intraocular lens.

[0157] P Embodiment 3. The apparatus of P Embodiment 1 or 2, wherein at least a portion of the intraocular lens is located within at least a recess.

[0158] P Embodiment 4. Any one of Embodiments 1 to 3, wherein the outer surface of at least one awning has a smooth shape for protecting the iris from the intraocular lens when the device is implanted in the posterior chamber.

[0159] P Embodiment 5. Any one of Embodiments 1 to 3, wherein the inner surface of at least one awning provides counterpressure to the tactile portion of the intraocular lens when positioning the intraocular lens on the device.

[0160] P Embodiment 6. A system comprising any one of Embodiments 1 to 5, further comprising an intraocular lens.

[0161] P Embodiment 7. The system of P Embodiment 6, wherein the intraocular lens is a one-piece intraocular lens or a multi-piece intraocular lens.

[0162] P Embodiment 8. The system of P Embodiment 6 or 7, wherein the one-piece intraocular lens is selected from the group consisting of monofocal, annular, multifocal, extended depth of focus, and receptacle-type intraocular lenses.

[0163] P Embodiment 9.P A method for implanting the device of Embodiments 1 to 8, comprising the steps of inserting the device into the posterior chamber and positioning a one-piece intraocular lens relative to a posterior platform such that at least a portion of the intraocular lens is located below at least one awning.

[0164] P Embodiment 10. The method of P Embodiment 9, wherein the tactile portion of the intraocular lens is located below at least one awning.

[0165] P Embodiment 11. A method for implanting the device of Embodiment 9 or 10, wherein the step of inserting the device into the posterior chamber includes inserting the device without transscleral fixation of the device.

[0166] P Embodiment 12. Any one of the embodiments 1 to 11 of P, wherein the rear platform is substantially ring-shaped.

[0167] P Embodiment 13. Any one of the embodiments 1 to 12, further comprising one or more stabilizing features.

[0168] P Embodiment 14. One of the devices from any one of Embodiments 1 to 13, wherein one or more stabilizing features comprises a plurality of bumpers projecting outward from a posterior platform, providing non-penetrating contact with intraocular ciliary tissue for centering.

[0169] P Embodiment 15. The rear platform comprises a substantially non-circular outer circumference and a substantially circular inner circumference, the device of any one of Embodiments 1 to 14.

[0170] P Embodiment 16. The device of any one of Embodiments 1 to 15, wherein the outer circumference is substantially rectangular and has a pair of elongated sides and a pair of short sides.

[0171] P Embodiment 17. A device from any one of Embodiments 1 to 16, wherein the plurality of bumpers comprises four bumpers, each of which extends radially outward from a position where the long side intersects with the short side.

[0172] Embodiment 18. Any one of Embodiments 1 to 17, wherein one or more stabilizing features include a rear stabilizing feature configured to engage with at least a portion of the lens capsule.

[0173] P Embodiment 19. A device from any one of Embodiments 1 to 18, wherein the rear stabilizing feature comprises a first portion projecting rearward from a surface facing the rear of the rear platform and a second portion projecting laterally outward from the first portion.

[0174] P Embodiment 20. One of the devices from any one of Embodiments 1 to 13, wherein one or more stabilizing features comprises a plurality of bumpers projecting outward from a posterior platform to provide non-penetrating contact with intraocular ciliary tissue for centering, and a posterior stabilizing feature configured to engage with at least a portion of the lens capsule.

[0175] P Embodiment 21. Any one of Embodiments 1 to 20, wherein the anterior part of the lens capsule supports the device along the Z-axis of the eye.

[0176] P Embodiment 22. A method for supporting an artificial intraocular lens (IOL) in an eye, comprising the step of preparing a lens support device for insertion into the eye, wherein the lens support device comprises a rear platform having a front-facing surface and a rear-facing surface, a central opening extending through the rear platform through which light passes towards the retina when the lens support device is implanted in the eye, at least one awning projecting over at least a portion of the front-facing surface of the rear platform, the at least one awning having an inner surface and an outer surface, and the awning forming at least one recess between the inner surface of the awning and the front-facing surface of the rear platform, and a bumper projecting radially outward from the device, A method comprising: a bumper having a radially outermost part for sutureless positioning within the posterior chamber for positioning a lens support device in the eye; positioning the lens support device behind the iris of the eye such that no part of the device is in contact with the sclera of the eye and the surface facing the rear of the posterior platform is positioned anterior to the anterior part of the lens capsule of the eye; positioning the radially outermost part of the bumper adjacent to a sulcus to position the central opening behind the pupil of the eye; positioning the optical portion of the IOL anterior to at least a portion of the surface facing the front of the posterior platform across the central opening; and positioning at least a portion of the tactile portion of the IOL in at least one recess for mounting the IOL to the lens support device.

[0177] P Embodiment 23. A method for implanting an artificial intraocular lens (IOL) in an eye, comprising the steps of creating an opening in the anterior wall of the lens capsule of the eye, and preparing a lens support device for insertion into the eye, wherein the lens support device comprises a main body having a central opening and a lens support structure, the lens support structure having a substantially flat lens support surface at least partially surrounding the central opening and at least one recess in front of the lens support surface, so that when the device is implanted in the eye, light passes through the central opening toward the retina, the main body, a plurality of radially extending structures coupled to the main body, each of the plurality of radially extending structures having a radially outermost part for sutureless positioning of the device in the posterior chamber of the eye, and a plurality of stabilizing features extending posteriorly from the rear surface of the lens support structure, A method comprising the steps of: inserting the lens support device behind the eye and the iris of the eye, and after insertion, ensuring that no part of the device rests in contact with the sclera of the eye; positioning the radial outermost part of each of the plurality of structures adjacent to the groove of the posterior chamber in order to stably position the central opening behind the pupil of the eye; inserting each of the plurality of stabilizing features through the opening in the anterior wall of the lens capsule in order to help fix the device to the lens capsule; inserting an IOL into the eye; positioning the optical portion of the IOL in front of at least a portion of the substantially flat lens support surface across the central opening; and fixing the IOL to the lens support device by positioning at least a portion of the tactile portion of the IOL in the at least one recess of the lens support structure.

[0178] P Embodiment 24. An implantable device for supporting an intraocular lens in an eye having an anterior portion of the lens capsule, comprising: a posterior platform having an inner wall that at least partially defines a central opening, such that when the device is implanted in the posterior chamber of the eye, light passes through the central optical element and the central opening toward the retina; and at least one awning, positioned over a front-facing surface of the posterior platform, forming at least one recess between the awning and the posterior platform, wherein the device is configured to be deployed without transscleral fixation of the device.

[0179] P Embodiment 25. The apparatus of P Embodiment 24, wherein the rear platform further comprises one or more notches around the central opening.

[0180] P Embodiment 26. The apparatus of Embodiment 24 or 25, wherein the rear platform is formed to be dimensioned on the front-facing surface of the rear platform to support the central optical element of an intraocular lens, and one or more notches are formed to be dimensioned to receive at least a portion of the tactile portion of the intraocular lens when the intraocular lens is embedded in at least one recess of the apparatus.

[0181] P Embodiment 27. Any one of the embodiments 24 to 26 of P further comprising one or more stabilizing features configured to engage with at least a portion of the lens capsule.

[0182] P Embodiment 28. Any one of the devices from Embodiments 24 to 27, wherein one or more stabilizing features extend behind at least one recess.

[0183] P Embodiment 29. Any one of the devices from Embodiments 24 to 28, wherein one or more stabilizing features extend forward of at least one recess.

[0184] P Embodiment 30. A method for implanting an artificial intraocular lens (IOL) in an eye, comprising the steps of: creating an opening in the anterior wall of the lens capsule of the eye; and preparing a lens support device for insertion into the eye, wherein the lens support device comprises a main body having a central opening, such that when the lens support device is implanted in the eye, light passes through the central opening toward the retina, and the main body further comprises a lens support surface at least partially surrounding the central opening and at least one recess in front of the lens support surface; and at least one stabilizing feature portion extending rearward from the rear surface of the lens support structure; and inserting the lens support device into the eye A method comprising the steps of: inserting the IOL behind the iris of the eye, and after insertion, ensuring that no part of the device is in contact with the sclera of the eye; inserting the at least one stabilizing feature through the opening in the anterior wall of the lens capsule to fix the lens support device to the lens capsule and position the central opening behind the pupil of the eye; inserting the IOL into the eye; positioning the optical portion of the IOL in front of at least a portion of the lens support surface across the central opening; and positioning at least a portion of the tactile portion of the IOL in the at least one recess to fix the IOL to the lens support device.

[0185] P Embodiment 31. The lens support device further comprises a plurality of radially extending structures coupled to the main body, each of the plurality of radially extending structures having a radially outermost portion for sutureless positioning of the device in the eye, and the method further includes the step of positioning the radially outermost portion of each of the plurality of radially extending structures adjacent to the groove of the eye to prevent rotation around the visual axis and assist in centering the device with respect to the eye, the method of P Embodiment 30.

Claims

1. In an implantable device for supporting an artificial intraocular lens (AIOL) inside the eye, A rear platform comprising a front-facing surface and an inner wall that at least partially defines a central opening, wherein when the device is embedded in the eye and supports the artificial intraocular lens, light passes through the optical portion of the artificial intraocular lens and the central opening of the rear platform toward the retina of the eye. At least one awning positioned over the forward-facing surface of the rear platform, wherein the at least one awning forms at least one recess in front of the rear platform, and the at least one recess is fitted to receive a portion of at least one tactile part of the artificial intraocular lens, A plurality of radially extending structures coupled to the device to stabilize the device within the eye, restrict the rotation of the device within the eye, and assist in centering the device with respect to the optical axis of the eye, The device comprises a radially extending outermost part adapted to suture-free positioning of the device within the eye, such that when the device is implanted in the eye, the device is in contact with the ciliary tissue and located behind the iris of the eye, and no part of the device is in contact with the sclera of the eye after implantation. Device.

2. The apparatus according to claim 1, wherein the at least one awning positioned across the forward-facing surface of the rear platform defines a front opening.

3. The apparatus according to claim 2, wherein the at least one awning includes a visual feature portion that protrudes inward from the at least one awning so as to reduce the dimensions of the front opening.

4. The apparatus according to claim 3, wherein, during use, the visualized feature portion is directly visualized through the pupil of the eye.

5. The apparatus according to claim 3, wherein the apparatus has an elongated shape comprising a long axis and a short axis, and the dimensions of the narrowed front opening are the distance between the central edges of the front opening along the long axis of the apparatus.

6. The apparatus according to claim 5, wherein the distance is at least about 5.0 mm to about 7.0 mm.

7. The apparatus according to claim 5, wherein the distance is greater than the diameter of the central opening.

8. It further comprises one or more rear stabilization features, The apparatus according to claim 1, wherein one or more rear stabilizing features extend rearward from the rear surface of the rear platform and are configured to engage with at least a portion of the lens capsule of the eye.

9. The apparatus according to claim 1, wherein the rear platform comprises a substantially non-circular outer circumference and a substantially circular inner circumference.

10. The outer circumference is substantially rectangular and has a pair of long sides and a pair of short sides. The apparatus according to claim 9, wherein the plurality of radially extending structures comprises four radially extending structures, and each of the four radially extending structures extends radially outward from a position where the long side intersects with the short side.

11. The apparatus according to claim 1, wherein the rear platform is in a plane, and the radially outermost of the plurality of radially extending structures is in the plane of the rear platform.

12. The apparatus according to claim 1, wherein the rear platform is in a plane, and the radially outermost of the plurality of radially extending structures is in front of the plane of the rear platform.

13. A system comprising the apparatus described in claim 2 and the artificial intraocular lens.

14. The system according to claim 13, wherein the device is configured to receive the artificial intraocular lens that forms the system before the system is implanted in the eye.

15. The system according to claim 13, wherein the artificial intraocular lens is a one-piece intraocular lens or a multi-piece intraocular lens, and the one-piece intraocular lens is selected from the group consisting of monofocal, annular, multifocal, extended depth of focus, and receptacle-type intraocular lenses.

16. The system according to claim 13, wherein the maximum dimension of the front opening is greater than the diameter of the central opening of the rear platform.

17. The system according to claim 16, wherein the diameter of the central aperture is smaller than the diameter of the optical portion of the artificial intraocular lens.

18. The system according to claim 13, wherein the central opening is circular and the front opening is non-circular.

19. The system according to claim 13, wherein the at least one awning comprises a first awning and a first connecting cover at the front end of the device, and a second awning and a second connecting cover at the rear end of the device.

20. The system according to claim 19, wherein the first joint cover protrudes inward from near the first corner of the device, and the second joint cover protrudes inward from near the second corner of the device opposite to the first corner.

21. The system according to claim 20, wherein the front opening has a first opening dimension and a second opening dimension, the first opening dimension extending from the first joint cover to the second joint cover, and the second opening dimension extending from the first awning to the second awning.

22. The system according to claim 21, wherein the first opening dimension is smaller than the second opening dimension.

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