Devices for supporting and positioning an intraocular lens in an eye and methods of use thereof

Abstract

The present disclosure provides an implantable device for supporting an intraocular lens in an eye. The device includes a posterior platform having an anterior-facing surface and an inner wall at least partially defining a central aperture. Light passes through the intraocular lens and the central aperture of the posterior platform toward the retina when the device is implanted in the eye. The device includes at least one canopy positioned over the anterior-facing surface of the posterior platform forming at least one recess in front of the posterior platform. The device is configured to be deployed behind the iris in the eye such that no part of the device contacts the sclera after implantation. Related tools, systems, and methods are also provided.

Description

[0001] This application is a divisional application of the invention patent application with application number 202180053094.7, application date August 6, 2021, entitled "Device for supporting and positioning an intraocular lens in the eye and method of using the same". Citation of relevant applications

[0002] This application claims priority to co-pending U.S. Provisional Application No. 63 / 063,110, filed August 7, 2020; co-pending U.S. Provisional Application No. 63 / 089,241, filed October 8, 2020; co-pending U.S. Provisional Application No. 63 / 129,448, filed December 22, 2020; and co-pending U.S. Provisional Application No. 63 / 183,488, filed May 3, 2021. The entire contents of these applications are incorporated herein by reference.

[0003] This application also relates to co-pending U.S. Application No. 16 / 988,519, filed August 7, 2020, which claims 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 these applications are incorporated herein by reference. Technical Field

[0004] This disclosure relates generally to the field of ophthalmology, and more specifically to an ophthalmic device for supporting and positioning an intraocular lens in the eye. Background Technology

[0005] Implantation of an intraocular lens (IOL) requires intraocular support to hold it in the correct position. This is typically achieved through the native capsular bag, suspended by suspensory ligaments (fine, thread-like structures). However, this support can be iatrogenically damaged during surgery (anterior or posterior segment) or due to other ocular procedures such as intravitreal injections. The posterior capsular bag is often affected, preventing the IOL from being securely placed within the capsular bag.

[0006] To overcome the loss of posterior capsule support due to posterior capsule rupture, surgeons typically place the IOL at the top of the anterior capsule, with the IOL haptics pointing towards the ciliary sulcus. However, this can cause numerous complications because commercially available IOLs are not optimized for this location. Specifically, their size and surface profile are not ideal for placement between the anterior capsule and the iris. Consequently, the IOL optics or haptics can cause inflammation of the iris or ciliary body, leading to adverse complications including uveitis, glaucoma, and hyphema (UGH) syndrome. This is particularly problematic with single-piece IOLs, so three-piece IOLs are often used in such cases. While three-piece IOLs with square-edged optics are commonly used, they can also cause iris abrasion, inflammation, pigment release, and glaucoma. Furthermore, most toric, multifocal, trifocal, and extended depth-of-focus lenses are only available in single-piece designs. Therefore, these techniques are not safe for implantation in patients with posterior capsule rupture.

[0007] Unless special measures are taken (such as optical capture), an IOL placed in the sulcus can become off-center, leading to decreased vision and photopsia, often requiring additional surgery. If the off-center IOL erodes into the iris, ciliary body, or retina, the problem can worsen, with a risk of permanent vision loss.

[0008] The management of secondary IOL implantation in cases of posterior capsular support deficiency is evolving. Currently, the only FDA-approved solution is anterior chamber IOL implantation (ACIOL). ACIOLs are larger lenses that can be placed in front of the iris; however, over time, these lenses can lead to UGH syndrome, as well as endothelial cell loss and corneal decompensation, making them contraindicated in many patients. Techniques such as iris suture IOLs, which are not clinically validated, can be used, but these are technically difficult and can cause iris pigment loss, leading to glaucoma. Finally, scleral suture IOLs with islands are technically complex, carry the risk of rotation, and have limited suture durability, leading to suture breakage and lens subluxation. Furthermore, all these techniques force surgeons to use alternative types of lenses instead of those they have chosen for the patient. Finally, the timing is crucial, as lens calculations during the initial vitrectomy / phacoemulsification are often inadequate, but the surgeon wishes to avoid additional surgery, thus often resulting in the implantation of a suboptimal lens. Summary of the Invention

[0009] In one aspect, an implantable device is provided for supporting an intraocular lens in an eye having an anterior segment of a capsular bag, an iris, and a sclera. The device includes a posterior platform having an anterior surface and an inner wall at least partially defining a central aperture. When the device is implanted in the eye, light passes through the intraocular lens and the central aperture of the posterior platform toward the retina. The device includes at least one awning situated above the anterior surface of the posterior platform, thereby forming at least one recess anterior to the posterior platform. The device is configured to be deployed behind the iris in the eye so that no part of the device contacts the sclera after implantation.

[0010] The at least one canopy located above the forward-facing surface of the rear platform can define an anterior opening. The at least one canopy can include an observation configuration that projects inward from the at least one canopy to reduce the size of the anterior opening. In use, this observation configuration allows direct visualization through the pupil of the eye. The device can be an elongated shape having a major axis and a minor axis. The size of the narrowed anterior opening can be the distance between the central edges of the anterior opening along the major axis of the device. This distance can be at least about 5.0 mm to about 7.0 mm. This distance can be greater than the diameter of the central aperture. During use, at least a portion of the intraocular lens is positioned against the forward-facing surface within the at least one recess. The outer surface of the at least one canopy can have a smooth geometry to protect the iris from injury to the intraocular lens when the device is implanted. When the intraocular lens is positioned on the forward-facing surface, the inner surface of the at least one canopy can provide counter-pressure to the haptics of the intraocular lens.

[0011] The device may further include one or more stabilizing structures. The one or more stabilizing structures may extend posteriorly from the posterior surface of the posterior platform and include a posterior stabilizing structure configured to engage at least a portion of the capsular bag. The posterior stabilizing structure 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. The one or more stabilizing structures 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 seamless positioning of the device within the eye. This radially outermost portion may be configured to provide non-penetrating contact with the ciliary muscle tissue in the eye to prevent rotation about the visual axis and to facilitate centering of the device relative to the eye. The posterior platform may include a substantially non-circular outer periphery and a substantially circular inner periphery. The outer periphery may be substantially rectangular and may have a pair of long sides and a pair of short sides. The plurality of radially extending structures may include four radially extending structures. Each of these four radially extending structures may extend radially outward from the location where the long side intersects the short side. The rear platform may be located in a plane, and the outermost radial portions of the plurality of radially extending structures are located in the plane of the rear platform. The rear platform may be located in a plane, and the outermost radial portions of the plurality of radially extending structures are located in front of the plane of the platform. At least one canopy may protrude in front of the outermost radial portion.

[0012] The anterior segment of the capsular bag can provide support for the device along the Z-axis of the eye. The posterior platform may also include one or more incisions around a central opening. The size and shape of the posterior platform allow it to support the central optic of the intraocular lens on its anterior surface, and the size and shape of the one or more incisions allow it to receive at least a portion of the haptic of the intraocular lens when the lens is implanted within the at least one recess of the device. The device may also include one or more stabilizing structures configured to engage at least a portion of the capsular bag. The one or more stabilizing structures may extend posterior to the at least one recess. The one or more stabilizing structures may extend anterior to the at least one recess.

[0013] In one related aspect, a system is provided comprising an implantable device for supporting an intraocular lens in the eye and the intraocular lens. The intraocular lens may be a single-piece intraocular lens or a multi-piece intraocular lens. The single-piece intraocular lens may be a monofocal, toric, multifocal, extended depth-of-focus, or adjustable intraocular lens.

[0014] In one related aspect, a method of implanting the device for supporting an intraocular lens in the eye is provided. The method includes inserting the device into the posterior chamber of the eye behind the iris; and positioning a single-piece intraocular lens relative to the posterior platform such that at least a portion of the intraocular lens is positioned under the at least one occluder, and at least a portion of the intraocular lens rests against the anterior surface. A haptic of the intraocular lens may be positioned under the at least one occluder. Inserting the device into the posterior chamber of the eye may include inserting the device without fixing it via the sclera.

[0015] In one related aspect, a method for supporting an intraocular lens (IOL) in an eye is provided, the method comprising preparing a lens support device for insertion into the eye. The lens support device includes a posterior platform having an anterior surface and a posterior surface; a central aperture through the posterior platform, wherein light passes through the central aperture toward the retina when the lens support device is implanted in the eye; at least one canopy projecting over at least a portion of the anterior surface of the posterior platform, the at least one canopy having an inner surface and an outer surface, the canopy forming at least one recess between the inner surface of the canopy and the anterior surface of the posterior platform; and a plurality of radially extending structures coupled to and projecting radially outward from the device, the radially extending structures having a radially outermost portion for seamless positioning within the posterior chamber to position the lens support device in the eye. The method further includes placing a lens support device in the eye behind the iris, such that the posterior surface of the posterior platform is positioned anterior to the anterior portion of the eye's capsule, and no part of the device contacts the sclera of the eye; positioning the outermost radial portion of the radially extending structure near the ciliary sulcus to position the central aperture posterior to the pupil of the eye; positioning the optic portion of the IOL above the central aperture and anterior to at least a portion of the anterior surface of the posterior platform; and positioning at least a portion of the loop of the IOL within the at least one recess to secure the IOL to the lens support device.

[0016] In one related aspect, a method for implanting an artificial lens (IOL) in the eye is provided, the method comprising forming an opening in the anterior wall of the eye's capsular bag and preparing a lens support device for insertion into the eye. The lens support device includes a body portion 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 periphery of the central opening, and at least one recess located anterior to the lens support surface. When 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 body portion. Each of the plurality of radially extending structures includes a radially outermost portion for seamlessly positioning the device within the posterior chamber of the eye; and a plurality of stabilizing structures extending posteriorly from the posterior surface of the lens support structure. The method further includes inserting the lens support device into the eye and posterior to the iris of the eye such that, after insertion, no part of the device contacts the sclera of the eye. The method further includes positioning the radially outermost portion of each of the plurality of structures near the ciliary sulcus of the posterior chamber to stably position the central opening behind the pupil of the eye; inserting each of the plurality of stabilizing structures through an opening in the anterior wall of the capsular bag to aid in anchoring the device relative to the capsular bag; inserting the IOL into the eye; positioning the optic portion of the IOL above the central opening and anterior to at least a portion of a substantially flat lens support surface; and positioning at least a portion of the haptic portion of the IOL within the at least one recess of the lens support structure to secure the IOL to the lens support device.

[0017] In one related aspect, a method for implanting an artificial lens (IOL) into the eye is provided, the method comprising forming an opening in the anterior wall of the eye's capsular bag; and preparing a lens support device for insertion into the eye. The lens support device includes a body portion having a central opening, wherein, when the lens support device is implanted into the eye, light passes through the central opening toward the retina. The body portion further includes a lens support surface at least partially surrounding the periphery of the central opening and at least one recess located anterior to the lens support surface; and at least one stabilizing structure extending posteriorly from the posterior surface of the lens support structure. The method further includes inserting a lens support device into the eye and behind the iris of the eye such that no part of the device contacts the sclera of the eye after insertion; inserting the at least one stabilizing structure through an opening in the anterior wall of the capsular bag to anchor the lens support device relative to the capsular bag and positioning the central opening behind the pupil of the eye; inserting an IOL into the eye; positioning the optics of the IOL above the central opening and in front of at least a portion of the lens support surface; and positioning at least a portion of the haptic of the IOL within the at least one recess to secure the IOL to the lens support device.

[0018] The lens support device may further include a plurality of radially extending structures coupled to the body. Each of the plurality of radially extending structures may include a radially outermost portion for seamlessly positioning the device within the eye. The method may further include positioning the radially outermost portion of each of the plurality of radially extending structures near the ciliary sulcus of the eye to prevent rotation about the visual axis and to help center the device relative to the eye.

[0019] In some variations, the compositions, methods, apparatus, and systems described above may include one or more of the following items in any feasible combination. Further details of the compositions, methods, apparatus, and systems are set forth in the accompanying drawings and the following description. Other features and advantages will become apparent upon reading the specification and drawings. Attached Figure Description

[0020] These and other aspects will now be described in detail with reference to the following accompanying drawings. Generally, these drawings are not drawn to scale, either absolutely or relatively, but are exemplary. Furthermore, the relative positions of structures and components can be modified for clarity.

[0021] Figure 1A A perspective view of one embodiment of the device is shown; Figure 1B It shows Figure 1A The device having an artificial lens (IOL) deployed therein. Figure 1C-1D yes Figure 1B A top view of the device; Figure 1E-1F yes Figure 1A-1B Additional view of the device; Figure 2A It shows Figure 1B A cross-sectional view of the device deployed inside the eye to support the IOL; Figure 2B As shown Figure 2A A top view of the implanted eye shown; Figure 3 Another embodiment of the device is shown; Figure 4A and 4B These are a side view and a perspective view of one embodiment of the device; Figure 5A This is a top view of another embodiment of the device; Figure 5B and 5C yes Figure 5A Other views of the device; Figures 6A-6CTop view, perspective view and cross-sectional view of an embodiment of the device incorporating multiple radially extending buffers and post-stabilization structures are shown respectively; Figure 6D yes Figure 6A A perspective view of the device positioned inside the eye and viewed through the pupil; Figure 6E yes Figure 6A A cross-sectional view of the device when it is implanted in the eye; Figure 7 A partial top view of an embodiment of the device having an anti-rotation fixing arm or chain is shown; Figures 8A-8C It is a perspective view of one relevant implementation scheme of the device; Figure 8D-8E They are Figure 8A Top and bottom views of the device supporting the intraocular lens; Figure 8F This is a side view of one possible embodiment of the device; Figures 9A-9B These are, respectively, a top view and a bottom view of one relevant implementation scheme of the device; Figure 10A A relevant embodiment of the device with a pre-stabilized structure is shown; Figure 10B It shows Figure 10A A cross-sectional view of the device when it is implanted in the eye; Figure 10C A relevant embodiment of the device with a pre-stabilized structure is shown; Figure 10D It shows Figure 10C A cross-sectional view of the device when it is implanted in the eye; Figure 11A-11F A related embodiment of a device having a canopy configured to accommodate an IOL is shown; Figures 12A-12C A related embodiment of a device having a canopy configured to accommodate an IOL is shown; Figures 13A-13E A related embodiment of a device having a canopy configured to accommodate an IOL is shown; Figure 14 A top view of an eye implanted with a device having a bias arm visible through the pupil is shown; Figure 15 A top view of a relevant embodiment of a device having multiple radially extending buffers and multiple transscleral fixation arms is shown; Figure 16A This is an end view of the anchoring pad that is coupled to the end of the fixed arm; Figure 16B yes Figure 16ASide view of the fixed arm; Figure 16C This is an end view of the anchoring pad that is coupled to the end of the fixed arm; Figure 17 This is a side view showing a straight front fixing arm designed to bias the device forward to prevent rearward displacement during outward movement of the anchor plate; Figure 18A A relevant embodiment of a device incorporating multiple transscleral fixation arms is shown; Figure 18B-18C Top and perspective views of relevant embodiments of the device incorporating multiple transscleral fixation arms and post-stabilization structures are shown respectively; Figure 18D A perspective view of a relevant embodiment of a device incorporating multiple transscleral fixation arms, multiple radially extending buffers, and a post-stabilization configuration is shown. Figure 18E A top view of a relevant embodiment of a device incorporating multiple transscleral fixation arms is shown; Figure 18F The cut-off line FF is shown. Figure 18E A cross-sectional view of the device; Figure 18G This shows the cut along line GG. Figure 18E A cross-sectional view of the device; Figure 18H It shows the implanted in the eye Figure 18G The device; Figure 18I-18J A top view and perspective view of a relevant embodiment of a device incorporating multiple transscleral fixation arms are shown; Figures 19A-19B A top view of a relevant embodiment of the device is shown; Figure 20A-20D A top view of the related device incorporating the reinforcement is shown.

[0022] It should be understood that the accompanying figures in this article are for illustrative purposes only and are not intended to be drawn to scale. Detailed Implementation

[0023] This invention relates generally to the field of ophthalmology, and more specifically, to an ophthalmic device comprising an artificial support structure that can be used to support an intraocular lens (IOL) or other ophthalmic implants when "in-pocket" implantation is not desired.

[0024] The most common treatment for aphakia resulting from cataract lens removal is the placement of an IOL within the natural lens capsule. The capsule, with its anterior and posterior portions forming the cavity, is supported by suspensory ligaments, providing a stable structure for the IOL support. A typical IOL consists of an optic and one or more loops supporting the optic within the eye. The design of the IOL largely determines its placement within the eye. For example, surgeons and patients sometimes prefer single-piece IOLs, such as multifocal, toric, and adjustable IOLs. These high-quality lenses are generally not suitable for placement within the ciliary sulcus because of the sharp geometry of their loop edges and their large anteroposterior loop thickness, which can damage the iris. However, in some cases, placement within the capsule is not ideal, such as due to tears or loss of the anterior or posterior capsule or suspensory ligaments.

[0025] The device described herein can be implanted in the posterior chamber of the eye and secured to the top of the anterior capsule to stably hold all types of IOLs (single-piece or multi-piece IOLs) with various haptic and optic designs, thus providing reliable refractive effects. The device described herein can be combined with specially designed constructions to accommodate toric IOLs by maintaining IOL orientation. The device also allows for posterior placement, which significantly reduces the risk of damage to the iris, anterior chamber angle, or cornea. Posterior implantation of the iris and cornea eliminates or reduces the risk of corneal injury, iris hemorrhage, and glaucoma. Compared to existing techniques such as ACIOLs, iris-sutured lenses, or scleral-sutured lenses, or compared to placing commercially available IOLs in the ciliary sulcus, the device described herein reduces the risk of complications. The device described herein provides surgeons and patients with a full range of IOL options.

[0026] Figure 1A-1D An embodiment of a lens support device 2100 for supporting and positioning an IOL 110 within the eye is shown. Figure 1A This is a perspective view of device 2100 before it is positioned at IOL 110. Figure 1B-1D The device 2100 is shown after positioning IOL 110 using the device 2100. Figure 2A A cross-sectional view of the eye model and the device 2100 deployed to support the IOL 110 is shown. Figure 2B An eye is shown looking through (or through, through) the iris 10, which is shown as transparent. Figure 2BAlso shown are the cornea 5, ciliary body 15, sclera 20, ciliary sulcus 25, and pupil 30 centrally defined through the iris 10. Device 2100 is configured to be positioned against the anterior segment 35 of the capsular bag between the anterior capsular segment 35 and the iris 10, within the posterior chamber above a capsulorhexis 40. The capsulorhexis 40 is an opening formed in the anterior wall of the capsular bag. The anterior capsular segment 35 is preferably intact, although in some embodiments of device 2100 the anterior segment 35 of the capsular bag may be partially torn. Device 2100 may include a posterior lens support structure or platform 2105 for positioning against the anterior capsular bag 35, one or more canopies 2110 projecting over a portion of the platform 2105, and one or more stabilizing structures, such as a plurality of radially extending structures or buffers 2114 coupled to the body of the device and configured to provide non-penetrating contact with ocular tissues. The posterior platform 2105 may support the IOL 110 and prevent it from falling into the posterior chamber upon implantation. The anterior segment 35 of the capsule provides Z-axis support for the posterior platform 2105. One or more awnings 2110, together with the platform 2105, form a main body that helps to position and secure the IOL 110 against the platform 2105 while protecting surrounding ocular tissues, such as the iris, from damage from contact with the IOL 110. Even the portions of the IOL 110 not covered by the awnings 2110 are effectively protected because they are recessed relative to the foremost surface of the device 2100 (i.e., the forward-facing surface of the awnings 2110). One or more buffers 2114 are positioned near the periphery of the platform 2105 and project outward from the device 2100 to non-invasively contact ciliary body tissues, such as the ciliary body 15 or ciliary sulcus 25, to achieve centering of the device 2100. One or more buffers 2114 also provide anti-rotation functionality in the Z-plane and / or prevent displacement in the Z-plane to maintain proper alignment between the central portion of the device and the visual axis of the eye. In some embodiments, one or more stabilizing structures may be arranged relative to the device to engage at least a portion of the capsule, such as the anterior capsule, to stabilize and achieve centering and fixation of the device relative to the eye (see [link to relevant documentation]). Figure 5A , Figures 8A-8F , Figures 9A-9B and Figure 10A-10D The stabilization configuration 2138 can engage with the tear cap in the anterior segment of the sac. The device can be configured to position the IOL 110 either before tear cap outside the sac or after tear cap inside the sac. Each of these embodiments will be described in more detail below.

[0027] IOL 110 typically includes a central optics section 112 and two loops 114, each loop being coupled to the optics section 112. Device 2100 can accommodate an IOL 110 having any of a variety of conventional designs, including multi-piece IOLs, single-piece IOLs, and plate designs. Similarly, the loops 114 of the IOL 110 can be of any of a variety of constructions. Loops 114 can be conventional open-loop loops, such as C-rings, J-rings, modified J-rings, or other loops. Single-piece IOLs can have open-loop loops similar to those of conventional three-piece IOLs. Single-piece IOLs can also incorporate integral plate loops. While device 2100 is shown as having one type of IOL (e.g., a multi-piece IOL or a single-piece IOL), it should be understood that another type of IOL can also be used with the device.

[0028] Refer again Figure 1AThe posterior lens support structure or platform 2105 of device 2100 may have an anterior lens support surface pointing forward of the eye when in use, and a posterior surface pointing backward of the eye and abutting against the capsular bag when in use. The posterior platform 2105 can provide multiple functions. The posterior platform 2105 may have a surface forming a stable platform (anterior or posterior), against which the IOL 110 can be positioned during use. The posterior platform 2105 can replace the capsular bag and can set the effective lens position of the IOL 110 within the eye. The geometric and mechanical functions of the posterior platform 2105 not only support the IOL 110 during use but can also help center the IOL 110 in cases of asymmetrical eyes or asymmetrical surgery. The posterior platform 2105 provides artificial anterior capsular support for the IOL and provides a stable platform structure in the eye to reproduce the native anterior capsular structure. The posterior platform 2105 may be substantially flat or planar between the anterior and posterior surfaces. The thickness of the posterior platform 2105 between the anterior and posterior surfaces can be minimized while still providing sufficient support for the IOL. This thickness can be between approximately 0.02 mm and 1.5 mm, or between approximately 0.5 mm and 1.0 mm. The posterior platform 2105 can be approximately 0.2 mm thick. The thickness of the posterior platform 2105 can be less than 0.2 mm and still provide sufficient support for the IOL. For example, a stiffer material can be used to reinforce the posterior platform 2105 to strengthen it and limit its deformation, even though the posterior platform 2105 is only 0.2 mm thick. Alternatively, the posterior platform 2105 can have a greater thickness (e.g., from approximately 0.50 mm to approximately 1.0 mm) and a material thickness sufficient to limit device deformation even when the device is under tension and / or pressure. Increasing the stiffness of the lens support structure helps to facilitate easier IOL insertion after implantation. As explained in more detail below, this also increases the circumferential strength of the orifice 2115 extending through the rear platform 2105, thus limiting the risk of an IOL accidentally passing through the orifice 2115 when implanted in the device 2100. The reinforcements to the device to avoid deformation and the risk of an IOL passing through the device described herein will be discussed in more detail below.

[0029] Still referencing Figure 1A-1DThe posterior platform 2105 may include an outer region 2111 defining the overall shape of the posterior platform 2105 and an inner wall 2109 defining a central opening or aperture 2115 extending from the anterior surface through the entire thickness of the posterior platform 2105 to the posterior surface. The central aperture 2115 is configured to be substantially coaxial with the optical axis of the IOL once the IOL is positioned on the posterior 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 toward the retina. The device securely holds the IOL 110 in a coaxial position. The central aperture 2115 may provide a generally annular shape for the posterior platform 2105. However, the posterior platform 2105 does not necessarily have to be circular on its inner and outer circumferential surfaces. For example, the inner wall 2109 of the posterior platform 2105 may be substantially circular, or may have a circumference forming a consistent generally circular shape. The outer region 2111 of the rear platform 2105 can be circular, but does not necessarily have to be circular. The outer region 2111 of the rear platform 2105 can have any of a variety of non-circular shapes, including, Figure 1A-1D The shape can be a rounded rectangle, or an oval, elliptical, rounded triangle, or other geometric or freeform shape. In some embodiments, the non-circular shape of the outer region 2111 includes multiple side lobes (or lobes) projecting outward from multiple sides. These side lobes may project radially away from the central aperture 2115. The multiple sides may be substantially flat or concave. Therefore, the rear platform 2105 may have a circumferentially varying width between the outer region 2111 and the inner wall 2109. The shape of the outer region 2111 of the rear platform 2105 and the interaction of the device 2100 within the eye will be described in more detail below. The non-circular shape of the outer peripheral surface may be a rounded rectangle with a pair of short sides 2107 and a pair of long sides 2108.

[0030] IOL 110 can be positioned above the central aperture 2115 by the rear platform 2105, such that the central axis CA extending through the central aperture 2115 extends through the optical section 112 of IOL 110 (see...). Figure 1BThis allows light to pass through aperture 2115 and the IOL 110 positioned on the rear platform 2105. Once the IOL is positioned against the rear platform 2105, the central aperture 2115 can be substantially coaxial with the optical axis of the IOL 110. The diameter of the central aperture 2115 allows the optics 112 of the IOL to be supported on the forward-facing surface of the rear platform 2105, without the IOL 110 falling into the rear chamber through the central aperture 2115. The diameter of the central aperture 2115 prevents the rear platform 2105 from substantially overlapping with the optics 112 of the IOL 110, thus allowing light to pass through the device without any optical interference as it travels toward the retina. The diameter of aperture 2115 is designed to be universal for various IOL types. Conventional IOLs typically have optics with an outer diameter of 6 mm, although this size can vary depending on the IOL. A central aperture 2115 having a diameter of less than 5.0 mm down to about 4.0 mm, preferably about 4.75 mm, can be used in certain IOLs. A central aperture 2115 having a diameter between 5.0 mm and about 6.0 mm can be used in most IOLs, thus the device is applicable to virtually any conventional loop-stabilized IOL. The minimum inner diameter of 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, at most up to about 10 mm, up to about 15 mm, or any range between these values. The inner diameter of central aperture 2115 can be between about 4 mm and about 8 mm, or between about 4 mm and 6 mm. The inner diameter of the central aperture 2115 can be close to the outer diameter of the optical part 112 of a typical IOL, for example, at least about 5.5 mm or 6.0 mm.

[0031] The diameter of the orifice can be selected to maintain specific circumferential strength, thereby limiting the risk of the IOL accidentally passing through the orifice 2115 during implantation. A smaller orifice diameter can improve circumferential strength compared to a larger orifice diameter. A stiffer IOL shell can limit deformation of the orifice 2115 under tension and / or pressure. Increasing the stiffness of the IOL shell also facilitates easier IOL insertion after intraocular fixation.

[0032] The central aperture 2115 does not necessarily have to be smaller than the IOL diameter. When the inner diameter of the central aperture 2115 is larger than the outer diameter of the IOL optics 112, the rear platform 2105 may incorporate one or more structures extending into the central aperture 2115 to effectively reduce the inner diameter of the central aperture 2115, thereby allowing the platform 2105 to support the IOL optics and prevent the IOL 110 from falling through the central aperture 2115. The device 2100 may include a plurality of leaflets configured to support the IOL optics. The leaflets may project inwardly relative to the inner wall 2109 of the platform 2105, thereby extending within the opening of the central aperture 2115. The leaflets may support the optics on their forward-facing surface, or the leaflets may be deflected such that the optics reach and are supported by the rearward-facing surface of the leaflet. The loop 114 of IOL 110 can be held on the forward-facing surface of platform 2105, while the optics 112 of IOL 110 can be positioned on the rearward-facing surface of the leaflets, thereby maintaining the Z position of IOL 110. The leaflets can be full-thickness or partially thick. This means that the leaflets can be as thick as platform 2105 or thinner than platform 2105. The leaflets can originate from the forward-facing surface of platform 2105. The leaflets can also originate from the rearward-facing surface of platform 2105. If the leaflets originate from the rearward-facing surface, then the optics 112 of IOL 110 can be positioned within a recess formed by the central aperture 2115 and the forward-facing surfaces of the leaflets. Device 2100 can include one, two, three, or more leaflets. Each leaflet can be arranged symmetrically around platform 2105. These leaflets can define an inner diameter narrower than the inner diameter of the central aperture 2115. The narrower inner diameter of the leaflet can be approximately 4.0 mm to 6.0 mm, or approximately 5.0 mm to 5.5 mm, or approximately 5.0 mm. The thickness of each leaflet can be approximately 0.10 mm to 0.50 mm, or approximately 0.15 mm to approximately 0.35 mm, or approximately 0.25 mm.

[0033] The central aperture 2115 may be the only aperture extending through the rear platform 2105, thus giving the platform 2105 a single optical aperture extending through its entire thickness. In some embodiments, in addition to the central aperture 2115, the rear platform 2105 also includes full-thickness openings. These additional openings can create a discontinuous rear surface for the device 2100, which can reduce the overall volume of the device while still providing sufficient surface area to support the IOL 110. In some embodiments, the discontinuous rear surface may include one or more cutouts 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 a front pouch to support the central optics 112 along the Z-plane (see [link]). Figures 9A-9BEach of these embodiments will be described in more detail below. In other embodiments, the rear platform 2105 (whether having a discontinuous or continuous surface) does not have a central aperture 2115 defined by the inner periphery 2109. A solid rear platform 2105 helps prevent the glass from dislodging. In some embodiments, the solid rear platform 2105 may be a planar optical surface configured to allow light to pass through. In other embodiments, the rear platform 2105 has refractive or filtering optical properties.

[0034] In some implementations, the rearward surface of the rear platform 2105 is configured to rest against the front bladder 35 (see...). Figure 2A The rearward-facing surface of the rear platform 2105 may include one or more features or may be textured to increase friction and prevent unintended movement of the device relative to the anterior capsule 35 after implantation. Increased friction helps to minimize lateral movement and / or rotational motion of the device 2100 relative to the anterior capsule 35.

[0035] IOL 110 Figure 1B The IOL 110 is shown arranged anteriorly against the posterior platform 2105. In some cases, there may be limited space between the anterior surface of the device 2100 and the posterior surface of the iris 10. To reduce the risk of iris injury or pupillary obstruction, the IOL 110 can be fixed above or behind the plane of the posterior platform 2105. The posterior platform 2105 can be configured to allow the surgeon to implant the IOL 110 relative to the device 2100 using an "optical capture" technique. In this technique, the optics 112 of the IOL 110 partially or completely passes through the central aperture 2115 to the posterior side of the posterior platform 2105, while the haptics 114 of the IOL 110 can be substantially held anterior to the posterior platform 2105. This technique achieves reliable fixation of the IOL 110, preventing displacement of the IOL 110 in the X, Y, or Z axes after surgery and reducing the space volume anterior to the lens. This technology also allows for the safe use of a "square-edge" IOL design by reducing contact between the IOL and the posterior surface of the iris 10. By providing effective lens placement options, surgeons can more flexibly modify the IOL's refractive power. The technology also allows for the use of astigmatism-correcting (torsional) IOLs by limiting IOL rotation. Furthermore, fixing the optics while enhancing the predictability of the refractive position of the optics allows for more accurate preoperative lens selection calculations.

[0036] To facilitate the use of optical capture technology, the aperture 2115 can have a diameter similar to that of a typical IOL optics, such as 5.5 mm or 6.0 mm. In this case, the surgeon can use a force parallel to the optical axis or by slightly tilting the IOL 110 to allow it to pass through the aperture 2115, thus facilitating the passage of the IOL 110. Alternatively, the device 2100 can be incorporated with a configuration that allows the diameter of the aperture 2115 to be temporarily enlarged to allow the IOL 110 to pass through. As described above, 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 an open ring with a gap between the ends of the ring. In this embodiment, the inner diameter of the aperture 2115 can vary depending on whether the ends of the rings are arranged facing each other or diverging. In another embodiment, the inner wall 2109 defining the central aperture 2115 may be discontinuous. The device 2100 may have one or more slits arranged circumferentially around the aperture 2115 in the inner wall 2109. These slits preferably have a radially outward length from the inner wall 2109 (e.g., 0.25 mm to 2.0 mm), thereby increasing the flexibility of the platform 2105 and enlarging the effective diameter of the central aperture 2115 to allow the optic 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 more than one deflectable flap, for example, 2 to 40 flaps, which deflect to allow the IOL 110 to pass through the aperture 2115 when sufficient force is applied by the surgeon. Alternatively, the inner wall 2109 may have a brush-like structure that deflects and allows the IOL 110 to pass through when subjected to sufficient force applied by the surgeon. In other embodiments, the cross-sectional thickness profile of platform 2105 may gradually decrease toward orifice 2115. The outer region 2111 of platform 2105 may have a greater thickness than the inner periphery of platform 2105 near the inner wall 2109 (e.g., the thickness measured from front to back when the device is positioned in the eye). Therefore, the central portion of platform 2105 (i.e., inner wall 2109) can have greater flexibility due to the reduced thickness, allowing IOL 110 to pass through orifice 2115 and deflecting inner wall 2109 when subjected to sufficient force. While the area near inner wall 2109 has greater flexibility, whether due to the presence of slits, fins, or reduced thickness, platform 2105 has sufficient strength to support IOL 110 disposed on the front surface of platform 2105 or IOL partially or completely located behind platform 2105.

[0037] Refer again Figure 1A-1BThe outer region 2111 of the posterior platform 2105 may be coupled to one or more sidewalls 2112 projecting forward from the outer region 2111. The sidewalls 2112 may be curved outward over the anterior surface of the posterior platform 2105 to form one or more awnings 2110. The awnings 2110, in combination with the sidewalls 2112, may form a body portion defining one or more recesses 2104 anterior to the anterior lens support surface. At least a portion of the IOL 110 may be positioned within one or more recesses 2104 of the body portion. As described above, the device 2100 may be inserted into the eye posterior to the iris such that, after insertion, no part of the device contacts the sclera of the eye. The outermost radial portion of each of the plurality of radially extending structures may be positioned adjacent to the ciliary sulcus of the posterior chamber to stably position the central opening 2115 posterior to the pupil of the eye. The IOL 110 can then be inserted into the eye and positioned such that the optics 112 of the IOL 110 are positioned above the central aperture 2115 of the rear platform 2105 and anterior to at least a portion of the lens support surface of the platform 2105. A peripheral region of the rearward-facing surface of the optics 112 may be arranged against the anterior surface of the rear platform 2105. Each haptic 114 of the IOL 110 may be substantially or at least partially located within a corresponding recess 2104 on the opposite side of the central aperture 2115, while the majority of the optics 112 of the IOL 110 remains outside the recess 2104 and is exposed through the front opening 2127 of the device 2100 (see [link]). Figure 1B ), to secure IOL 110 to device 2100.

[0038] The space between the canopy 2110 and / or the sidewalls 2112 can define an elongated anterior opening 2127. The anterior opening 2127 can be large enough to allow easy passage and implantation of all types of IOLs (single-piece, three-piece, plate, etc.) while still allowing at least a portion of the haptic 114 of the IOL 110 to remain within the recess 2104 under the canopy 2110, thus keeping the IOL 110 behind the canopy 2110. The sidewalls 2112 can project anteriorly from the anterior surface of the posterior platform 2105 a sufficient distance to provide height for the recess 2104, allowing easy passage and entry of the haptic 114 under the canopy 2110. This is particularly helpful for surgeons implanting single-piece IOLs preferred by patients. Single-piece IOLs can include monofocal, toric, multifocal, extended depth-of-focus, and adjustable IOLs. However, the dimensions of the recess 2104 and the thickness of the device 2100 are minimized to reduce contact between the device and the posterior side of the iris when the device is positioned against the anterior sac. For example, the device 2100 may have a thickness of approximately 0.3 mm to approximately 2.0 mm from the forward-facing surface of the canopy 2110 to the rearward-facing surface of the platform 2105. The anteroposterior thickness of the device is minimized to avoid interaction or contact between the canopy 2110 and the iris, and even in the event of contact, the smooth outer surface geometry and rounded edges of the canopy 2110 and sidewall 2112 prevent iris damage. The height of the recess 2104 between the forward-facing surface of the rear platform 2105 and the inward-facing surface of the canopy 2110 may be at least approximately 0.65 mm, at least approximately 0.70 mm, at least approximately 0.75 mm, up to approximately 1.00 mm. The height of the recess 2104 provides space within which the IOL can be manipulated relative to the device. In some embodiments, the rear platform 2105 has a thickness of approximately 0.20 mm and a recess height of approximately 0.65 mm. In some embodiments, the rear platform 2105 has a thickness of approximately 0.50 mm and a recess height of approximately 0.75 mm. Therefore, even if the rear platform 2105 is thicker, the height of the recess 2104 can be greater.

[0039] The size and shape of the canopy 2110 enable it to cover potentially damaging surfaces of the IOL 110 when the IOL 110 is positioned on the device 2100. For example, the loops 114 of the IOL 110, or the junctions 115 between the loops 114 and the optics 112, especially those designed to be fully implanted within the capsule, can be formed of materials that are damaging to ocular tissues or have surface geometries that are damaging to ocular tissues. For example, sharp or square IOL edges can cause damage to delicate ocular tissues such as the iris. The canopy 2110 of the device 2100 is designed to at least cover these surfaces of the IOL 110 to protect the iris from contact with them.

[0040] In other embodiments, the size and shape of the canopy 2110 may allow it to have at least one portion that protrudes more centrally than the others, to allow the device to be viewed from the front through the pupil. The pupil diameter during IOL implantation may be unpredictable and may change during the procedure. The centrally protruding viewing feature 2117 of the canopy 2110 can be used to directly view the device 2100 through the pupil while avoiding interference with the optics of the IOL after implantation. The centrally protruding feature narrows the inner diameter of the anterior opening 2127, for example, along the inner diameter of the device's long axis. The canopies 2110 on opposite sides of the device 2100 can define the distance between their central edges, which is at least about 7.0 mm down to about 5.0 mm, preferably about 6.0 mm. The ability to directly view the device 2100 during IOL implantation increases the likelihood that the IOL is properly secured within the device. Reference will be made below. Figure 18E-18J The front observation configuration of the device will be described in more detail.

[0041] In some embodiments, the device 2100 has a single sidewall 2112 extending around the periphery of the platform 2105 and forms a single canopy 2110 extending 360 degrees around the central aperture 2115, such that the edges of the optics 112 and the haptic 114 of the IOL 110 are at least partially covered. In other embodiments, the device 2100 has multiple canopies 2110 coupled to the platform 2105 via multiple sidewalls 2112. For example, as Figure 1A-1B As shown, the device 2100 may have a first canopy 2110 protruding over the forward-facing surface of the first short side 2107 of the platform 2105 and a second canopy 2110 protruding over the forward-facing surface of the opposite short side 2107 of the platform 2105. Each canopy 2110 may have an arc length around the central aperture 2115 such that the total surface area of ​​the canopy 2110 and the sidewalls 2112 around the central aperture 2115 is less than 360 degrees. Each canopy 2110 may cover only a portion of each tactile portion 114 of the IOL, and the edge of the optical portion 112 is exposed. The canopy 2110 is preferably not suspended above the optical portion 112 of the IOL 110, so that the elongated front opening 2127 is much larger than the diameter of the optical portion 112. This contrasts with the smaller central aperture 2115 of the rear platform 2105, which is close to the diameter of the central optical portion 112 of the IOL 110. The front opening 2127 is typically significantly larger than the central opening 2115. Even if the canopy 2110 can be combined with one or more observation configurations 2117, the front opening 2127 defined by the canopy 2110 can still be larger than the central opening 2115 (see [link]). Figure 1E , 3 (e.g., 15, 18A, 18I, etc.)

[0042] Figure 1A-1D The illustrated embodiment has a single sidewall 2112 extending around the entire periphery of platform 2105 along two long sides 2108 and two short sides 2107 at the location of canopy 2110. In this embodiment, opposing canopies 2110 may be fully connected to each other along the edge 2108 of the complete housing surrounding the rear platform 2105, forming a front opening 2127. However, the sidewall 2112 does not necessarily have to extend around the entire periphery of platform 2105. A first sidewall 2112 may project forward from the short side 2107 of platform 2105 to connect to canopy 2110, and a second sidewall 2112 may project forward from the opposite short side 2107 of platform 2105 to connect to its corresponding canopy 2110. In this embodiment, the front opening 2127 in the space between canopies 2110 is not adjacent to the wall forming the continuous opening 2127 on any side. Nevertheless, an opening 2127 is present for inserting IOL 110 into recess 2104.

[0043] The long side 2108 can be relatively straight or curved. In some embodiments, the long side 2108 may include an inwardly curved recess 2113 near the middle of the long side 2108 (see [link to relevant documentation]). Figures 19A-19B The recess 2113 can be located between the positions of the buffer 2114. The recess 2113 can have an inward radius of curvature that is a mirror image of the outward radius of curvature of the buffer, thus providing an overall S-shaped curvature for each long side 2108 when viewed from above. The recess 2113 of the sidewall 2112 on the long side 2108 provides an hourglass shape for the base.

[0044] In some embodiments, the canopy 2110 protrudes asymmetrically from the rear platform 2105. For example, a first canopy 2110 or a first portion of canopy 2110 may protrude a first distance from its corresponding sidewall 2112. A second canopy 2110 or a second portion of canopy 2110 may protrude a second distance from its sidewall 2112, different from the first distance. This asymmetry makes it easier to insert the front or rear loop 114 of the IOL 110. The front loop 114 can be inserted under the larger canopy 2110 first, and then the rear loop 114 can be inserted under the smaller canopy 2110. The front opening 2127 defined by the canopy 2110 (and optionally the sidewall 2112) can be asymmetrical, thereby achieving specific coverage of certain portions of the IOL relative to other portions, as will be described in more detail below. The canopy 2110 may also have intermittent or discontinuous sections, such as slits or brush-like structures, to improve the flexibility of insertion into each lens.

[0045] A recess 2104, sized to receive at least a portion of the IOL 110, may be defined by the forward-facing surface of the rear platform 2105, the inner surface of the sidewall 2112, and the inner surface of the canopy 2110. The height or volume of each recess 2104 may be sufficient to receive at least a portion of one or more of the corresponding loops 114 within its front-to-back thickness and its depth or distance from the central axis CA of the central aperture 2115. The inner surface of the sidewall 2112 may also serve as a support surface for the loops 114 and provide counter-pressure to the loops to help center the IOL 110 on the device 2100. The canopy 2110 may restrict the forward Z-axis movement of the loops 114 and facilitate securing the IOL 110 to the device 2100. Reliable IOL fixation, including one-piece IOLs, allows the use of IOLs requiring strict centering tolerances (e.g., toric, multifocal, extended depth of focus (EDOF) IOLs, and adjustable IOLs). The sidewalls 2112 and canopy 2110 have arc lengths sufficient to accommodate various haptic designs.

[0046] The dimensions (e.g., height) of the recess 2104 between the canopy 2110 and the rear platform 2105 can vary along the canopy 2110 and, in some embodiments, can be narrower or shorter than the front and rear thickness of the IOL loop 114, at least in some areas. As described above, the recess height between the forward-facing surface of the rear platform 2105 and the inward-facing surface of the canopy 2110 can be between approximately 0.65 mm and approximately 0.75 mm. This height does not necessarily have to be constant. A first region of the canopy 2110 can protrude forward more than another region of the same canopy 2110 (e.g., the region covering the end of the loop 114). The higher first region of the canopy 2110 can create a wider space sufficient to accommodate the IOL joint (e.g., the joint cover 2130). The lower second region of the canopy 2110 can create a narrower space. The narrower space created by the canopy 2110 compresses the IOL loop 114 within this space and causes the end of the loop 114 to face a more rearward position than when the loop 114 is biased. As described in more detail below, the rear platform 2105 may include a peripheral cutout 2144 arranged to align with the loop 114 of the IOL 110 when the IOL optics 112 is supported by the rear platform 2105 (see [link to relevant documentation]). Figures 8A-8E The size and shape of the cutout 2144 make it suitable for receiving IOL loops 114, allowing them to sink into the cutout 2144, thus below the level of the forward-facing surface of the rear platform 2105. Figure 8F A side view of one embodiment of the device 2100 is shown.

[0047] The wall thickness of the one or more canopies 2110 and / or sidewalls 2112 may be uniform or non-uniform. In some embodiments, the canopies 2110 and / or sidewalls 2112 may each have a uniform thickness of approximately 0.35 mm. The material forming the canopies 2110 and / or sidewalls 2112 may be continuous or discontinuous. Discontinuous material may form a support that minimizes the overall volume of the device 2100 while still providing a protective and / or support surface for the IOL 110.

[0048] As described above, the shape of the outer region 2111 of platform 2105 can be substantially non-circular (e.g., rectangular, elliptical, oval, hourglass-shaped, free-form), having a major axis defining the long side 2108 and a minor axis defining the short side 2107. Conversely, the inner periphery or inner wall 2109 can define a circular central aperture 2115. In this embodiment, the recesses 2104 formed by the canopy 2110 can be arranged opposite each other relative to the main axis, such that the span of the loop 114 of IOL 110 can be accommodated within the recesses 2104. The non-circular shape of the outer region 2111 can be a rounded triangle with multiple side lobes projecting outward from multiple sides, as described elsewhere herein. The canopies 2110 can project over the forward-facing surface of the rear platform 2105, such that they are arranged substantially opposite each other. Regardless of orientation, the span of the recess 2104 defined by the canopy 2110, sidewalls 2112, and rear platform 2105 is sufficient to accommodate the span of the IOL loop 114 therebetween. The IOL can be inserted into the recess 2104 located below the canopy 2110 and between the sidewalls 2112. The diameter between the first and second opposing sidewalls 2112 is sufficient to allow IOL insertion. The IOL is typically foldable, so the diameter between the first and second canopies 2110 can vary considerably. In other embodiments, which will be described in more detail below, the platform 2105 may have a cutout 2144 wide enough that the outer region 2111 of the rear platform 2105 is located radially inward of the sidewalls 2112 of the device 2100. This allows the sidewalls 2112 of the device 2100 to provide a first shape to the device 2100 that differs from the shape of the rear platform 2105. For example, the sidewall 2112 can give the device 2100 a polygonal shape, while the rear platform 2105 can be generally annular (see [link]). Figure 8C ).

[0049] Although the span of the recess 2104 can accommodate the span of the IOL loop 114, the span of the recess can be slightly smaller than that of the IOL loop 114, so that the loop 114 is slightly compressed by the inner support surface of the sidewall 2112. The IOL 110 can be positioned relative to the device 2100 such that the loop 114 is at least partially bent. If the loop 114 is severely bent due to an overly tight fit, the optical part 112 of the IOL 110 will deform. If the loop 114 does not contact the sidewall 2112 due to an overly loose fit, the optical part 112 of the IOL 110 may be unstable relative to the device, causing it to shift and / or fall out of the device 2100. Figure 1E and 1F The dimensions of the device 2100 accommodating the IOL 110 are shown. The dimensions of the one or more recesses 2105 are, for example, such that they accommodate at least a portion of the IOL 110 along the thickness direction within the Z-axis, their arc length providing room for rotation of the IOL relative to the device 2100 during implantation, or their width providing a degree of coverage to conceal the loop edge from contact with the iris. The inner surface of the canopy 2110 and the forward-facing surface of the platform 2105 ( Figure 1E The depth of the recess 2104 between arrow A in the diagram can be between approximately 0.15 mm and approximately 1.50 mm. The platform 2105 along its short axis ( Figure 1F Arrow B) The width between the sidewalls 2112 can be between approximately 6.0 mm and approximately 11.0 mm. The span between the opposite recesses 2104 ( Figure 1F Arrow C) can be between approximately 8.0 mm and approximately 12.5 mm. In another embodiment, the platform is approximately 10.2 mm long, approximately 7.0 mm wide, and approximately 0.60 mm deep. In other embodiments, the platform's external length along the long axis of the device can be approximately 9.2 mm, and its internal length along the same axis can be approximately 8.5 mm, resulting in a sidewall thickness of approximately 0.7 mm. In other embodiments, the platform's external length along the long axis can be increased to approximately 11 mm, and its internal length along the same axis is approximately 9.8 mm. Therefore, the sidewall thickness is approximately 1.2 mm. The increased cavity length provides more space within which the IOL can be manipulated, which, combined with the increased sidewall thickness, provides an increased overall device length. The device can be secured via the ciliary body plana and thus behind the apex of the ciliary body, thus allowing space for implantation of a larger IOL shell even if the device is too wide in the plane of the ciliary body apex (see...). Figure 18H ).

[0050] The apparatus described herein is also configured to utilize optical capture technology. IOL 110 can be arranged relative to apparatus 2100 such that the optics 112 of IOL 110 is rearward to the rear surface of apparatus 2100, while the loops 114 of IOL 110 are held in front of the rear surface of apparatus 2100. The loops 114 of IOL 110 can be positioned within a recess 2104 of apparatus 2100, while at least a portion of the optics 112 of IOL 110 passes through an aperture 2115 in platform 2105 to the rear side of apparatus 2100. The edges of the IOL optics can be positioned behind the rear surface of apparatus 2100, while the loops 114 extend forward through aperture 2115, such that they are held in front of the rear surface of apparatus 2100.

[0051] As mentioned above, the diameter of the front opening 2127 can be larger than the diameter of the central opening 2115 of the rear platform 2105. Figure 1A and Figure 3 A central aperture 2115 extending through the rear platform 2105 is shown, visible through the larger front opening 2127. The central aperture 2115 is preferably circular, but the front opening 2127 does not necessarily have to be circular. Figure 3 The circular central aperture 2115 and the generally elliptical front opening 2127 are shown. Figure 1C A circular central opening 2115 and a substantially rectangular anterior opening 2127 are shown. The anterior opening 2127 can have any of a variety of geometries or freeform shapes. In some embodiments, the anterior opening 2127 may be combined with one or more external incisions configured to extend over and cover selected areas of the IOL 110, as will be described in more detail below. The anterior opening 2127 may also be combined with one or more centrally extending features to allow direct observation of the device 2100 through the pupil during implantation, even if the pupil size narrows during the procedure. The centrally extending features may protrude to define at least one narrower diameter around the circumference of the anterior opening 2127, which is less than about 7 mm down to about 5 mm, preferably about 6 mm. Reference will be made below. Figure 18E-18J The centrally extending structure will be discussed in more detail.

[0052] The front opening 2127 can be larger than approximately 6 mm, allowing the IOL to be manipulated into position and fully extended into the recess 2104. The diameter of the front opening 2127 can be larger than 6 mm, up to approximately 8 mm. Figure 1CA generally rectangular front opening 2127 is shown, having a width along arrow A between the side walls 2112 and a length along arrow C between the awning 2110. The width and length can be between approximately 5 mm and approximately 10 mm. For the generally rectangular opening 2127, the length is greater than the width. Along... Figure 1C The size of arrow B in the diagram can also be between 5 mm and 10 mm. For a dimension of 5 mm in all directions, the sidewalls 2112 and the canopy 2110 mimic the anterior bladder, the front opening 2127 mimics the ruptured bladder, and only the central optic 112 of the IOL 110 is exposed through the front opening 2127. Preferably, the front opening 2127 is larger than this value, such that along... Figure 1C The width of arrow A in the image is approximately 6.25 millimeters, along... Figure 1C The length of arrow C in the image is approximately 7.5 millimeters, along... Figure 1C The size of arrow B in the image is approximately 8.0 millimeters.

[0053] As described above, the dimensions of the anterior opening 2127 can be large in all directions, and the dimensions of the canopy 2110 are adapted to receive the peripheral region of the loop 114 of the IOL 110. This large size of the anterior opening 2127 ensures that the device 2100 can universally accept almost any type of IOL. This large size, which makes insertion of the IOL 110 easier, also allows some portions of the IOL 110 to be exposed through the anterior opening 2127, where it might be more desirable to cover these portions when implanted before the pouch. Figure 5A An embodiment of a device 2100 is shown, having a front opening 2127 defined by a pair of canopies 2110 and a pair of engagement shields 2130. In this embodiment, the device 2100 has a substantially rectangular or hourglass shape, and the canopies 2110 project from the sidewalls 2112 onto the rear platform 2105 at each short side 2107 of the rectangle. The first engagement shield 2130 may be located near a first corner of the device projecting from the sidewalls 2112, close to the location where the first long side 2108 intersects the first short side 2107. The second engagement shield 2130 may be located near opposite corners of the device projecting from opposite sidewalls 2112, close to the location where the opposite long side 2108 intersects the opposite short side 2107. This arrangement ensures that the engagement shields 2130 extend from the sidewalls 2112 onto the main hinge point of the loop 114 and / or the engagement 115 where the loop 114 connects to the optical section 112 of the IOL 110. The presence of the engagement cover 2130 provides free shape for the front opening 2127. The front opening 2127 can have a shape along... Figure 5A The larger opening size of arrow B and along Figure 5AThe smaller opening size is indicated by arrow D. The IOL 110 can be inserted through the front opening 2127 along the first orientation to utilize the larger opening size along arrow B. Once the IOL 110 has passed through the front opening 2127, it can be rotated a distance about the central axis CA toward arrow D to ensure that the loop engagement 115 is covered by the engagement cover 2130 and that the IOL 110 is secured against the platform 2105. Due to the presence of the engagement cover 2130, the size of the canopy 2110 can be minimized, and the size of the front opening 2127 can be maximized.

[0054] As described above, device 2100 may include a stabilizing configuration provided by a plurality of radially extending structures coupled to the body portion. The radially extending structures or buffers 2114 provide the outermost radial portion of the device to help center the device 2100 intraocularly and achieve seamless positioning of the device intraocularly (e.g., in the posterior chamber). In some embodiments, device 2100 is configured such that, upon implantation, the posterior surface of the posterior platform 2105 abuts against the anterior segment 34 of the capsule, thereby allowing the capsule to provide Z-axis support for device 2100 (see [link to relevant documentation]). Figure 2A The buffer 2114 can extend outward from the device to provide X-axis and Y-axis support for the device 2100 and help prevent the device 2100 from rotating in the Z-plane. The ciliary body 15 has a substantially circular or elliptical shape, with its vertical axis being on average 0.5 mm longer than its horizontal axis. The substantially circular or elliptical device 2100 can achieve centering relative to a similarly circular or elliptical ciliary body. However, matching the shape to achieve 360-degree contact between the device 2100 and the ciliary body 15 can lead to inflammation or damage, which can negatively affect aqueous humor production. The buffer 2114 can protrude beyond the periphery of the platform 2105 to achieve intraocular centering of the device 2100 without 360-degree contact with the ciliary body 15 or the ciliary sulcus 25. In a preferred embodiment, the device 2100 has an outer peripheral surface with a substantially non-circular geometry. The platform 2105 can have an outer region 2111 that is substantially rectangular or hourglass-shaped. The buffer 2114 can extend outward beyond the outer periphery of the platform 2105 to further reinforce this non-circular geometry. For example, in Figure 1A-1F In the embodiment of the illustrated device 2100, the buffer 2114 is positioned at each corner of the rectangular body portion and configured to engage with the ciliary body 15 and / or ciliary sulcus 25 along a direction less than 360 degrees. The non-circular external geometry of the device 2100 allows for centering of the device 2100 without 360-degree contact with ocular tissues along its substantially non-circular outer peripheral surface. The shape of the device 2100 provides sufficient contact between the buffer 2114 and ocular tissues (e.g., the ciliary body or capsular bag) to aid in the centering and support of the IOL 110 without causing inflammation or damage.

[0055] The buffer members 2114 may be arranged symmetrically relative to the main body. The device 2100 may have a substantially rectangular shape and include four buffer members 2114 projecting outward from each corner. The device 2100 may also include two buffer members 2114 projecting outward from each short side 2107 or each long side 2108. In other embodiments, the device 2100 may include a single buffer member 2114 projecting outward from the device or other buffer members 2114 arranged symmetrically around the perimeter of the device 2100. The device 2100 may incorporate any number of buffer members 2114, including one, two, three, four, or more.

[0056] In some embodiments, the shape of the buffer 2114 allows contact with ocular tissue at an angle of approximately 120 degrees or less, preferably between 20 and 40 degrees. The contact between each buffer 2114 and adjacent ocular tissue can vary depending on the configuration of the buffers and the patient's anatomy. In some embodiments, each buffer 2114 may contact ocular tissue at an angle of approximately 5 to approximately 10 degrees, or preferably less than approximately 30 degrees. Devices with more buffers 2114 may have a greater degree of contact with ocular tissue compared to devices with fewer buffers 2114. Minimizing contact between the buffers 2114 and ocular tissue can significantly reduce the risk of inflammation or damage to aqueous humor production. The substantially non-circular shape of the device, partially provided by the buffers 2114, allows for slight contact between the device 2100 and the ciliary body, achieving centering without requiring a precise fit to the patient's specific dimensions. The radius of curvature of the buffer 2114 can be smaller than the radius of curvature of the ciliary process. Therefore, the buffer 2114 can contact the ciliary process at one, two, three, or four different points, rather than within a calculable range. For example, in use, the substantially non-circular outer peripheral surface of the device 2100 can contact the ciliary process at these different points.

[0057] In other embodiments, once the device 2100 is implanted, the buffer 2114 of the device 2100 can be positioned near ocular tissues (e.g., the ciliary body), but avoiding contact with the ocular tissues. This arrangement allows the buffer 2114 to help center the device. During implantation, if the device 2100 is positioned too far away in one direction, the adjacent buffer 2114 may abut against the ciliary body, thereby forcing the device 2100 away from the ciliary body and promoting a more centered position. Once the device is implanted, the buffer 2114 of the device can be positioned near ocular tissues (e.g., the ciliary body), with or without contact with the ocular tissues. The buffer 2114 can substantially align the central axis CA of the device 2100 extending through the central aperture 2115 with the visual axis of the eye and stabilize the flat surface of the posterior platform 2105, which is 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.

[0058] The buffer element 2114 can be a discontinuous or intermittent structure with one or more openings extending therethrough. For example, the buffer element 2114 can be shaped as a ring or part of a ring with an inner and outer diameter. The buffer element 2114 can be coupled to the rear platform 2105 or sidewall 2112 of the device 2100 such that it protrudes outward a distance away from these areas. Both ends of each buffer element 2114 can be coupled to the device 2100, or only one end of each buffer element 2114 can be coupled to the device 2100, thereby providing a C-shaped form for each buffer element 2114. Therefore, the buffer element 2114 can be any of closed-loop, open-loop, flat, Kelman, and various loop types, with or without one or more openings extending therethrough.

[0059] In some embodiments, the buffer 2114 provides a maximum outer diameter for the device 2100, which is sufficient to achieve centering due to contact with the ciliary body and / or ciliary sulcus. In some embodiments, the buffer 2114 is an annular structure projecting outward from each corner of a rectangular rear platform 2105. The buffer 2114 may have a first end 2132 and a second end 2134 projecting from a region of the body portion, such as from a sidewall 2112, from an 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 [link to relevant documentation]). Figure 1FEach buffer 2114 may have a radial cross-section between approximately 1.10 mm and approximately 1.0 mm, and an axial cross-section between approximately 0.1 mm and approximately 1.0 mm, or between approximately 0.2 mm and approximately 0.4 mm. In some embodiments, the dimensions of the axial cross-section allow the buffer 2114 to be inserted into the ciliary groove. The protrusion distance of each buffer 2114 beyond the sidewall 2112 of the body portion may vary. Each buffer 2114 may have an inner diameter ID measured from the outer surface of the sidewall 2112 to the inner surface of the intermediate region 2136 of the buffer 2114. This inner diameter may be between approximately 0.25 mm and approximately 3.0 mm. Each buffer 2114 may have an outer diameter OD measured from the outer surface of the sidewall 2112 to the outer surface of the intermediate region 2136 of the buffer 2114. This outer diameter may define the maximum outer diameter of the device 21000 produced by the buffer 2114. The maximum outer diameter can be between approximately 12.5 mm and approximately 16.0 mm, or between 9.0 mm and approximately 13.0 mm. Device 2100 is configured to be placed in the posterior chamber. The buffer 2114 may, but does not necessarily, be located within the ciliary sulcus during use. In some embodiments, the buffer 2114 may define a maximum outer diameter that allows it to be inserted within the ciliary sulcus when the device is centered around the visual axis. In other embodiments, the buffer 2114 may define a maximum outer diameter that allows it to remain outside the ciliary sulcus when the device is centered around the visual axis. The size of the buffer 2114, protruding from the periphery of the device, allows it to abut or gently contact the ciliary body tissue to limit rotation. The buffer 2114 may also contribute to the centering of the device. For example, the buffer 2114 may be thinner and positioned relatively posteriorly when the device 2100 is implanted in the eye, such that it contributes to centering but does not protrude into the ciliary sulcus.

[0060] In one embodiment, the length of the device 2100 between the outer surface of the buffer 2114 on the short side 2107 and the outer surface of the buffer 2114 on the opposite short side 2107 ( Figure 1F The arrow L) can be between approximately 6 mm and approximately 12 mm. The width between the outer surface of the buffer 2114 on the long side 2108 and the outer surface of the buffer 2114 on the opposite long side 2108 of the device 2100 (… Figure 1F The arrow (W) can be between approximately 7 mm and approximately 14 mm. The buffer 2114 can protrude outward by a distance that allows the buffer 2114, rather than the sidewall 2112 or rear platform 2105 of the device 2100, to contact the ciliary muscle tissue to achieve centering and prevent rotation. Figure 2A-2BThe buffer 2114 is shown to protrude into the ciliary sulcus 25, while the main body formed by the rear platform 2105, sidewalls 2112 and canopy 2110 is substantially kept within the space defined by the ciliary body 15, and preferably does not abut against the ciliary body 15.

[0061] The buffer 2114 can urge the device 2100 away from adjacent eye tissue upon contact. Compared to a solid sheet of material, the discontinuity of the buffer (i.e., the internal volume defined by the inner diameter of the toroidal surface) provides a greater degree of flexibility and elasticity to the buffer 2114 when the outer diameter abuts against the eye tissue. In some embodiments, the buffer 2114 can deform slightly or collapse slightly inward upon contact with the ciliary structure. The deformation of the buffer 2114 can be temporary, allowing it to return to its original shape, thereby urging the device 2100 away from the eye tissue and back to a centered position within the eye. Compression of the buffer does not negatively affect the performance of the device 2100. This means that one or more buffers 2114 can be compressed while the remainder of the device 2100 provides proper IOL capture, centering, tilting, etc.

[0062] Once the device 2100 is implanted, the buffers 2114 can protrude sufficiently away from the outer area of ​​the device, allowing them to be positioned near the ciliary structure, but preferably avoiding contact with it. The buffers 2114 can act as guides during intraocular positioning of the device 2100 and prevent displacement in the Z-plane to maintain proper alignment between the central aperture 2115 and the visual axis of the eye during implantation. Due to its toroidal or annular shape without square edges, the smooth, convex outer surface of the buffers 2114 also ensures that contact between the buffers and ocular tissues does not cause damage. The buffers 2114 have a minimal anteroposterior thickness (i.e., axial cross-section) to limit interaction with the iris, thereby preventing iris adhesion and angle closure.

[0063] Figures 4A-4BOne embodiment of the buffer 2114 is shown, wherein the buffer 2114 is angled and biased forward to hold the device 2100 and IOL 110 behind the iris. As described above, each buffer 2114 may be an annular structure projecting outward from the device 2100. The first end 2132 and the second end 2134 of the buffer 2114 may be positioned further back than the middle portion 2136 of each buffer 2114, which extends slightly forward. The middle portion 2136 of each buffer 2114 may contact the eye tissue, and this slight forward bias facilitates the rest of the device 2100 in a more rearward direction and helps to avoid iris contact and abrasion. In some embodiments, the buffer 2114 may project from the front surface of the device 2100, or may be angled such that the middle portion of each buffer 2114 protrudes beyond the front surface of the device 2100 formed by the canopy 2110. When one or more buffers 2114 are compressed due to the angle of the buffers 2114, the device 2100 can be driven rearward. In addition, one or more surfaces of the buffers 2114 may be textured or incorporated with constructions to increase friction with the ciliary process or ciliary sulcus in order to limit the rotation of the device 2100 relative to the eye.

[0064] The device 2100 may alternatively or additionally include one or more stabilizing structures 2138, which may be located behind or in front of one or more recesses 2104 of the main body, the main body formed by the rear platform 2105, the sidewall 2112 and the canopy 2110. Figures 5A-5C Examples 6A-6E, 8A-8F, 9A-9B, 18B-18D, and 19A-19B illustrate embodiments of a device having a post-stabilization structure 2138 positioned after the recess 2104. Figure 10A-10D An embodiment of the apparatus with a pre-stabilization structure 2138 positioned prior to the recess 2104 is shown. Various embodiments of the apparatus will be described in more detail below.

[0065] The stabilizing structure 2138 can project rearward from the rearward surface 2140 of the rear platform 2105 and can project laterally outward along the rearward surface 2140, thereby defining a space 2142 within which the anterior segment 35 of the capsular pouch surrounding the capsulorhexis 40 can be positioned. The stabilizing structure 2138 is configured to be posterior to the anterior capsular pouch, while the remainder of the device 2100 is anterior to the capsular pouch, providing Z-axis support. Once implanted, the stabilizing structure 2138 can engage with the capsulorhexis 40 within the anterior capsular pouch 35 to prevent accidental movement of the device 2100. The stabilizing structure 2138 can align the central axis CA of the device 2100 relative to the capsular pouch 35 to ensure proper positioning of the optics 112 of the IOL 110, which engages with the device 2100, relative to the visual axis of the eye.

[0066] The configuration of the stabilization structure 2138 can vary. The stabilization structure 2138 may include an open loop, a closed loop, a plate, a wing, a continuous elliptical structure, flexible finger-like protrusions, or other configurations. Typically, the stabilization structure 2138 includes one or more protrusions configured to insert through the tear bladder 40 and engage the inner surface of the anterior segment of the pouch 35, such that the rearward surface 2140 of the rear platform 2105 abuts against the front outer surface of the pouch 35. Any of a variety of structures can be considered for the stabilization structure 2138 herein, providing a rearward protruding surface configured to engage with the tear bladder 40 and a peripheral protruding surface preventing the device 2100 from sliding forward relative to the pouch 35.

[0067] In one embodiment, the stabilization configuration 2138 may have a first portion 2116 and a second portion 2118 coupled to and extending laterally outward from the first portion 2116. The first portion 2116 may be positioned near the inner wall 2109 of the rear platform 2105 defining the central orifice 2115. The first portion 2116 may project rearwardly from the rearward surface 2140 of the platform 2105 by a distance, thereby defining the size of the space 2142 between the rearward surface 2140 and the second portion 2118. The projection of the first portion 2116 is sufficient to allow the anterior bladder 35 of the pouch to be inserted between the rearward surface 2140 of the platform 2105 and the second portion 2118, such that the ruptured bladder 40 engages with the first portion 2116. The first portion 2116 may be an annular structure defining an outer diameter sized to pass through and engage with the anterior ruptured bladder 40. However, the first portion 2116 need not be a complete annulus. For example, the first part 2116 may be formed by a plurality of protrusions arranged on or around the central opening 2115 (see Figures 5B-5C 6A-6C and 8A-8F).

[0068] The second portion 2118 of the stabilizing configuration 2138, projecting laterally outward from the first portion 2116, may define an outer diameter larger than that defined by the first portion 2116. As described above, the first portion 2116 is sized to extend within and be received by the tear bladder 40. The second portion 2118 is sized to extend within the pouch (or, in the absence of a complete pouch, after the anterior portion of the pouch) and along the inner surface of the anterior pouch 35 for a distance. Thus, the anterior pouch 35 of the pouch may be positioned between the second portion 2118, located after the pouch, and the rearward surface 2140 of the platform 2105, located before the pouch. The second portion 2118 may be a pair of wings extending outward in opposite directions away from each other. The second portions 2118 of the stabilizing configuration 2138 may together project outward on opposite sides beyond the rear platform 2105 for a distance. For example, each second portion 2118 may have a length greater than the distance between the inner wall 2109 and the outer region 2111, such that each second portion 2118 extends beyond the outer region 2111 on opposite sides by a distance (see...). Figure 5A The span of the stabilization configuration 2138 along the minor axis of the device 2100 can be 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 the periphery of the rear platform 2105 in at least two regions, but the second portion 2118 can protrude outward from one, two, three or more regions, and from the entire periphery of the platform 2105. The rear platform 2105 (and the device 2100) can have any of a variety of shapes, including rounded rectangles, ovals, ellipses, triangles, etc. If the rear platform 2105 is rectangular, elliptical, or hourglass-shaped with a long side 2108 and a short side 2107, then the second portion 2118 can form two wings protruding outward from each long side 2108. The outwardly protruding second portion 2118 can be located below the notch 2113 on the long side 2108. The hourglass profile provided by recess 2113 allows the stabilizing structure 2138 to contact the rear surface of the device with a certain minimum diameter and extend a certain minimum radial distance, but remains visible when viewed from above (see below). Figures 19A-19BThe radial outward extension distance of the second portion 2118 can be minimized, which simplifies the insertion process of the device and provides sufficient stability relative to the pouch. If the posterior platform 2105 is a triangle with three side lobes or a triangle with three corners and three sides, then the second portion 2118 can form three wings projecting outward from each side of a rounded rectangle between these side lobes. If the posterior platform 2105 is circular, then the second portion 2118 can project outward along the entire circumference of the circle, thereby forming a fully projecting elliptical or circular flange and providing 360-degree support and stability relative to the anterior pouch. These are some examples of combinations of peripheral shapes and winged protrusions. Other examples are also considered herein.

[0069] The relative position of the stabilization configuration 2138 can be varied such that the span of the second part 2118 is along the minor axis of the device 2100 or along the major axis of the device. Figure 5A The stabilizing structure 2138 shown is arranged to project outward from the two long sides 2108 of the main body and is configured to engage with the pouch. The stabilizing structure 2138 can be arranged such that the wing formed by the second portion 2118 is perpendicular or orthogonal to the opposing recess 2104 of the loop 114 into which the IOL 110 is inserted. In other words, if the opposing recess 2104 is located on the short side 2107 of the device 2100, then the opposing wing of the stabilizing structure 2138 can be located on the long side 2108 of the device 2100. However, the wing of the stabilizing structure 2138 can be arranged around the device 2100 in any of a variety of orientations to provide engagement and stability with the anterior pouch 35.

[0070] The external dimensions of the second portion 2118, protruding from the periphery of the rear platform 2105, can have any of a variety of shapes, including oval, elliptical, rectangular, square, triangular, or other freeform shapes. The external dimensions can also be curved or protrude along another dimension. For example, the second portion 2118 can lie in a plane parallel to the rear platform 2105, the distance between the plane and the rear platform 2105 being equal to the longitudinal length of the first portion 2116 (see [reference]). Figure 5B Alternatively, the second portion 2118 of the stabilizing configuration 2138 may also have an angle, curvature, or an outward protrusion configured to engage with the inner surface of the anterior bladder, thereby providing rearward bias to the device 2100. The stabilizing configuration 2138 may have discontinuities within these wings projecting outward from the periphery of the platform 2105. For example, the second portion 2118 positioned within the bladder may include one or more openings penetrating the region of the wings. The openings or discontinuities may also include one or more recesses, grooves, or other surface features near the outer periphery of the second portion 2118. These features can provide flexibility during operation and also allow fluids (e.g., viscoelastic substances) to escape from the bladder.

[0071] The stabilizing structure 2138 can engage with the tear capsule 40 to center the device 2100. The diameter of the tear capsule 40 can be between approximately 4 mm and approximately 7 mm, or between approximately 5 mm and approximately 6 mm. The first portions 2116 can be spaced apart from each other by a distance at least as large as the diameter of the central orifice 2115 and slightly larger relative to the tear capsule 40. Excessive size can allow the tear capsule 40 to be under slight tension, improving the fixation of the device 2100 relative to the capsule. In one embodiment, the tear capsule is approximately 5.5 mm, while the outer diameter defined by the first portions 2116 (whether fully annular or formed by a pair of protrusions) can be approximately 6.0 mm. Other dimensions are also considered herein.

[0072] The rearward-facing surface 2140 of platform 2105 can abut against the outer surface of the anterior capsule 35 of the sac. A first portion 2116 of the stabilizing structure 2138 can engage with the thromboplastin 40, and a second portion 2118 of the stabilizing structure 2138 can be inserted into the sac and abut against the inner surface of the anterior capsule 35. Z-axis support can be provided by the anterior capsule 35 of the sac, and centering of device 2100 can be provided by the engagement between the stabilizing structure 2138 and the thromboplastin 40. Device 2100 does not need to engage or contact with the ciliary process or ciliary sulcus for centering. IOL 110 can enhance device 2100 and improve the stability of these thromboplastin engagement structures.

[0073] Figures 6A-6E An embodiment of a device 2100 having multiple buffers 2114 and a stabilizing structure 2138 is shown. The rear platform 2105 is a rounded rectangular shape with four buffers 2114, each buffer protruding outward from the periphery of the platform 2105 near a corner of the rectangle. A wing of a second portion 2118 of the stabilizing structure 2138 extends outward from the long side 2108 between the buffers 2114. In this embodiment, the wing of the second portion 2118 has a circular or elliptical shape; however, it should be understood that any of a variety of shapes is conceivable. Figure 6B A perspective view of the rear side of device 2100 is shown. The buffer 2114 projects radially outward, such that the entire buffer 2114 lies approximately in a single plane parallel to the rearward surface of platform 2105. As described above, the buffer 2114 may be angled relative to the rearward surface of platform 2105, such that the middle portion 2136 is positioned further forward than the ends 2132, 2134. The ends 2132, 2134 of the buffer 2114 are also coupled to a further rearward region of sidewall 2112. The ends 2132, 2134 of the buffer 2114 may also be coupled to a further forward region of sidewall 2112. Figure 6AThe illustrated embodiment also has four buffers 2114, each of which protrudes outward from one corner of the main body of the rectangle. It should be understood that the device may include two buffers 2114 that protrude outward above the short side 2107 of the rectangle, such that a first end 2132 is coupled to a sidewall 2112 near the first long side 2108, and a second end 2134 is coupled to a sidewall 2112 near the opposite long side 2108, thereby extending the middle portion 2136 around the entire short side 2107.

[0074] Figures 6B-6C The stabilization configuration 2138 is shown to project rearward from the rearward surface 2140 of the rear platform 2105, such that the plane of the wing 2118 is behind the plane of the buffer 2114. This allows the wing 2118 of the stabilization configuration 2138 to be positioned behind the forward section 35 of the pouch, while the buffer 2114 can be inserted into the ciliary groove 25 (see [link]). Figure 6E The space 2142 between the wing 2118 and the rearward surface 2140 of the rear platform 2105 can receive the front section 35 therein, such that the tear bladder 40 surrounds the first part 2116 of the stabilization structure 2138. Figure 6E The posterior segment of the capsule is shown missing. IOL 110 is shown located within a body portion that forms part of the lens shell of the IOL. The optic portion 112 of IOL 110 is shown positioned between sidewalls 2112 and abutting the forward surface of the posterior platform 2105, thus covering the central aperture 2115. The posterior surface 2140 of the posterior platform 2105, the stabilizing structure 2138, and the IOL 110 covering the central aperture 2115 create a barrier between the posterior chamber and the vitreous body. The forward surface of the canopy 2110 is positioned behind the iris 10. Preferably, the canopy 2110 does not contact the iris 10; however, the smooth outer surface of the canopy 2110 is designed not to damage or irritate the iris 10 in the event of contact. The coupling cover 2130 provides additional coverage to the loop 114 in the area where the loop 114 and the optical part 112 of the IOL 110 form a coupling 115, thereby preventing the area from contacting the iris 10.

[0075] The device 2100 described herein can be combined with any combination of stabilizing structures. In some embodiments, the device 2100 includes a plurality of buffers 2114 configured to extend toward the ciliary structure and a stabilizing structure 2138 arranged further rearward to engage at least a portion of the pouch (see [link to previous embodiment]). Figures 6A-6E , Figures 8A-8F and Figures 9A-9B In other embodiments, device 2100 includes only a plurality of buffers 2114, without any stabilizing structure 2138 (see [link to other embodiments]). Figure 1A-1F(2A-2B3 and 4A-4B). In some embodiments, device 2100 does not include buffer 2114 and stabilizing structure 2138, which are arranged more rearward relative to the body of the device and configured to engage at least a portion of the bladder bag before the body of the device is in position for bladder tearing (see 2A-2B3 and 4A-4B). Figures 5A-5C In other embodiments, device 2100 does not include buffer 2114 and stabilizing structure 2138, which are arranged further forward relative to the body of the device and configured to engage at least a portion of the bladder bag when the body of the device is after the bladder has been ruptured (see [link to relevant documentation]). Figure 10A-10D Some of the devices described herein are arranged such that the majority of the device is positioned anterior to the pouch and supported by the anterior portion of the pouch. Other devices described herein are arranged such that the majority of the device is positioned within the pouch, while still being supported by the anterior portion of the pouch (e.g., a tearing pouch). This will be described in more detail below.

[0076] The stabilization configuration provides reliable positioning relative to the capsular bag and / or ciliary sulcus to ensure that the device 2100 remains fixed to or relative to the anterior segment of the capsular bag. In some embodiments, the device 2100 may also be additionally incorporated with a tether 2120 (also referred to herein as a fixation arm) that prevents the device 2100 from rotating about the visual axis in the Z-plane (vertical plane) of the eye. Figure 7 An embodiment of a device 2100 incorporating a tether 2120 protruding from a sidewall 2112 is shown. The tether 2120 may protrude from any of a plurality of locations on the device 2100, including only the short side 2107, the long side 2108, or a corner or vicinity of the device 2100. The tether 2120 may be designed to have rigidity and length that allows it to function as a rigid spacer element. A rigid or elastically capable tether 2120 may rely on penetration or wedging into place by adjacent tissue. Preferably, the tether 2120 is very flexible such that it does not drive the centering of the device 2100 and that the position of the IOL is not dominated by the patient's scleral diameter. In one embodiment, the device 2100 may include a posterior stabilization structure 2138 and the tether 2120 to limit rotation without applying excessive reaction forces. The device may include, for example, Figure 7The single tether 2120 shown, or in combination with one, two, or three tethers or fixation arms secured to the sclera using outwardly displaced anchors 2125, is described in U.S. 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 secured to the iris or another part of the eye. The anti-rotation tether 2120 may be particularly useful when the device is intended for use in conjunction with a toric IOL, in which case even a minimal rotation about the visual axis can result in severe deformation. The tether 2120 can provide a stable artificial suspensory ligament fixation for the device.

[0077] The device may include at least three fixation arms 2120 configured to be placed under tension for intraocular positioning and stabilization of the device. Each of the three fixation arms 2120 may extend outward from a corresponding one of a plurality of sides. One or more fixation arms 2120 may be substantially straight between their supporting starting point 2103 and their ending point 2102. The straight fixation arm or front fixation arm 2120 may extend along a single longitudinal axis L between the starting point and the ending point without any bending or turning away from the single longitudinal axis L (see [link to documentation]). Figure 7 The straight fixing arm can extend perpendicularly to the outer peripheral surface of the outer wall of the support structure. The longitudinal axis L of the straight fixing arm can be arranged perpendicular to the outer peripheral surface of the outer wall. The plane of the forward-facing surface of the support structure and the longitudinal axis L of the straight fixing arm can be parallel to each other, and the plane of the rear-facing surface of the support structure and the longitudinal axis L can also be parallel to each other. (See below for reference.) Figure 11A-11F 12A-12C, 13A-13E, 14, 15, 16A-16C, 17, 18A-18D, 18E-18H and 18I-18J illustrate relevant embodiments of the device 2100 having multiple fixed arms 2120 in more detail.

[0078] Figure 8A An embodiment of the device 2100 with a rear platform 2105 is shown, the rear platform 2105 having a central opening 2115 and a peripheral cutout 2144. Figure 8E It shows Figure 8A The device 2100, wherein IOL 110 is located within the main body; Figure 8DThe rear side of device 2100 and the relative arrangement of the peripheral incision 2144 and loop 114 of IOL 110 are shown. The peripheral incision 2144 minimizes the device's volume and allows for a reduction in overall anteroposterior thickness. Device 2100 can be positioned within the posterior chamber of the eye anterior to the sac. The anteroposterior thickness of device 2100 is important for whether device 2100 interacts with the posterior surface of the iris. Minimizing the anteroposterior thickness of device 2100 limits the interaction between device 2100 and the iris. The posterior platform 2105 may have two peripheral incisions 2144, one arranged along a first short side 2107 of device 2100 and the second arranged along a second opposing short side 2107. This arrangement positions each incision 2144 below the location of the IOL loop 114 when IOL 110 is positioned within device 2100. Each cut 2144 can be relatively elongated, such that the extension length of the cut 2144 is approximately equal to the length of the short side 2107. For example, the cut 2144 can extend from the corner where the short side 2107 and the first long side 2108 of the device intersect to another corner where the short side 2107 and the opposite long side 2108 intersect. The width of the cut 2144 can vary along its length, such that the width of the cut 2144 is wider at the first corner and narrower at the opposite corner. The cut 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 loop is located. The shape of the cut 2144 is defined by the rearward surfaces of the outer wall 2111 and the side wall 2112 of the rear platform 2105. The outer wall 211 can define a first side of the cut 2144, and the rearward surface of the side wall 2112 of the device can define the opposite side of the cut 2144. The overall shape of the cutout 2144 can be similar to the shape of the IOL loop 114. The size and shape of the narrower end of the cutout 2144 can be adapted to the end region of the receiving loop 114, while the wider end of the cutout 2144 can be close to the position where the loop 114 joins the optical part 112 (see [reference]). Figure 8D The cut 2144 allows the end region of the flexible IOL loop 114 to be convex in a rearward direction toward the region of the cut 2144, for example, by a canopy 2110. The presence of the cut 2144 can create a curved outer wall 2111 for the rear platform 2105, which, together with the circular inner wall 2109 forming the central aperture 2115, creates an annular shape for the rear platform 2105. In some embodiments, the cut 2144 can be wide enough that the outer region 2111 of the rear platform 2105 is radially inwardly located at the sidewall 2112 of the device. This allows the sidewall 2112 of the device 2100 to have a first shape, while the rear platform 2105 of the device 2100 has a different second shape. For example, the sidewall 2112 can create a rectangular or polygonal shape for the device 2100, while the rear platform 2105 is generally annular. Figure 8D The sidewalls 2112 of the device 2100 are shown to be in a substantially rectangular or square shape, while the rear platform 2105 formed by the cutout 2144 is more annular in shape. Figures 8B-8C Another embodiment of the device 2100 is shown. The size of the cut 2144 is relative to... Figure 8D The cutout 2144 in the middle is larger, thus creating a rear platform 2105 that is closer to an annular shape. Regardless of the overall size of the cutout 2144 that accommodates the loop 114, the size of the rear platform 2105 makes it suitable for supporting the central optical section 112.

[0079] In some implementations, the device 2100 does not have a rear support 2105, but instead uses a front pouch to support the central optics 112. Figures 9A-9B A device 2100 is shown having sidewalls 2112 that curve inward to form a canopy 2110, which forms the forward-facing surface of the device 2100. The canopy 2110, combined with the sidewalls 2112, creates a body portion defining an internal recessed region in which the IOL 110 can be placed. The body portion facilitates the arrangement and fixation of the IOL 110 within the device 2100 while protecting surrounding ocular tissues. The device 2100 is configured to be positioned against the anterior segment of the capsular bag, between the anterior capsular segment and the iris within the posterior chamber, and above the capsulorhexis. In this embodiment, the anterior capsular segment is preferably intact. The anterior segment of the capsular bag can provide Z-axis support for the IOL positioned behind the canopy 2110. One or more buffers 2114 project outward from the sidewalls 2112 to non-invasively contact ciliary body tissues, such as the ciliary body or ciliary sulcus, thereby achieving centering of the device 2100 and preventing rotation.

[0080] exist Figures 9A-9BIn the embodiment of the device shown, the rearward surface of the sidewall 2112 forms the rear surface of the device 2100, which forms part of the housing of the IOL. As with other embodiments described herein, when the device 2100 is implanted, the body of the device 2100 is held before capsulorhexis, and the stabilizing structure 2138 extends after capsulorhexis. A buffer 2114 can extend outward from the sidewall 2112 toward the ciliary sulcus. Since the device lacks a posterior platform 2105, the rearward surface of the IOL remains exposed at the rear end of the device 2100. Therefore, when positioned within the device 2100 implanted in the eye, the IOL can, for example, contact at least a portion of the anterior segment of the capsular bag. The anterior surface of the IOL is at least partially covered by the canopy 2110 and the engagement shield 2130 of the device 2100, thereby protecting the iris from any side of the IOL 110. The stabilizing structure 2138 can project rearward from the device and includes a lateral extension 2118 as described elsewhere herein. When the device 2100 is positioned in the edge, the edges of the tear bladder can extend over portion 2118 so that they are behind the tear bladder. The remainder of the body of the device 2100 can remain before the tear bladder. The IOL positioned within the recess defined by the sidewalls 2112 and the canopy 2110 can be supported on the Z-plane by the front section of the bladder, even though the lateral protrusions 2118 of the stabilizing structure 2138 extend after the tear bladder. The size and shape of the body prevent the device 2100 from falling through the tear bladder into the bladder. Additionally, the distance between the sidewalls 2112 accommodates the span of the loop 114. The loop 114 can also be slightly compressed by the inner support surfaces of the sidewalls 2112 to help hold the IOL in place, as described elsewhere herein.

[0081] Figure 10A-10D Some embodiments of device 2100 are shown, wherein device 2100 is configured to be secured intraocularly after capsulorhexis, while at least a portion of the device remains prior to capsulorhexis. As with other embodiments described elsewhere herein, device 2100 can engage with the capsulorhexis for fixation and stabilization; however, the majority of the device (and the IOL positioned within a recess of the device) lies within the capsular pouch behind the capsulorhexis 40. This implantation method eliminates the risk of iris interaction.

[0082] Device 2100 can be designed such that engagement with the endoscopic capsule avoids significant changes in the shape and orientation of device 2100. Device 2100 may incorporate one or more reinforcements to prevent deformation. These reinforcements allow the device to engage with the eye, such as with the endoscopic capsule, in a manner that provides secure fixation while preventing deformation. The device described herein can be reinforced to match or exceed the compressive force applied by the capsule. The compressive force applied by the capsule depends on the diameter of the endoscopic capsule, and therefore on the diameter of the portion of the device engaged with the capsule. The compressive force applied by the capsule also depends on the diameter, shape, and mechanical properties of the endoscopic capsule. The diameter, shape, and mechanical properties of the endoscopic capsule can be estimated but not precisely predicted. Therefore, a device adaptable to a range of scenarios is preferred. The front and / or rear surfaces of device 2100 may be thickened and / or reinforced with materials to prevent deformation due to the forces exerted on device 2100 by the capsule. The sidewalls 2112 and / or corners of device 2100 may be thickened and / or reinforced to limit bending. A reinforcing ring may be incorporated near the point where the device engages with the endovascular unit. This reinforcing ring may be an integral or embedded material that is harder than the material used to form other areas of the device (e.g., canopy 2110, sidewall 2112, or rear platform 2105), such as a nickel-titanium alloy or plastic. These materials provide sufficient reinforcement while being flexible enough to be inserted through small incisions described elsewhere herein.

[0083] Figure 20A-20D An apparatus incorporating various types of reinforcements 145 is shown. Figure 20A A reinforcement element incorporated in the rear platform 2105 of the device is shown, the reinforcement element having the shape of a ring 2145. The reinforcing ring 2145 may surround the orifice 2115 and may be formed by increasing the material thickness of the platform 2105 in that region or by embedding auxiliary materials, such as plastic or metal, to provide higher circumferential strength. Figure 20B A reinforcing ring 2145 in the posterior platform 2105 is shown. The posterior platform 2105 has a discontinuous surface due to the presence of one or more cuts 2144. As described elsewhere herein, the cuts 2144 minimize the volume and thickness of the device, making it easier to insert into the eye. However, the cuts 2144 may reduce the circumferential strength of the device, making it more susceptible to deformation by forces exerted by the pouch. By incorporating the reinforcing ring 2145 within the discontinuous posterior platform 2105 (e.g., embedding a polymer or material with greater rigidity than the material of the platform 2105) or by altering the material properties of the discontinuous posterior platform 2105 (e.g., the anteroposterior thickness of the platform), it is possible to provide the device with additional circumferential strength against the pouch, while the cuts 2144 ensure sufficient flexibility for insertion into the eye. Figure 20C Another configuration of reinforcements in the form of one or more slender beams 2145 arranged along the reinforcing long side 2108 of the sidewall 2112 is shown. Figure 20D Another embodiment is shown, in which a reinforcing ring 2145 surrounds the orifice 2115 and is combined with a reinforcing beam 2145 along the corner near the buffer 2114. Any of a variety of reinforcing shapes and arrangements can be considered herein to reinforce the device while still allowing insertion through a small cutout.

[0084] Device 2100 may incorporate a stabilization structure 2138 as described elsewhere herein. The stabilization structure 2138 may project forward from the forward-facing surface of device 2100 and laterally outward, thereby defining a space 2142 within which the anterior segment 35 of the capsular pouch surrounding the capsulorhexis 40 is positioned. The stabilization structure 2138 is configured to be positioned anterior to the anterior capsular pouch 35, while the remainder of device 2100 is positioned posterior to the capsulorhexis 40. The stabilization structure 2138 allows the central axis CA of device 2100 to be aligned relative to the capsular pouch 35, ensuring proper positioning of the optics 112 of the IOL 110, which is coupled to device 2100, relative to the visual axis of the eye.

[0085] The configuration of the stabilization structure 2138 can vary, but once the device 2100 is positioned in the eye, the stabilization structure 2138 for this embodiment must be difficult to penetrate the laceration capsule. The stabilization structure 2138 may include an open loop, a closed loop, a wing, a plate, a continuous elliptical structure, flexible finger-like protrusions, or other configurations. The stabilization structure 2138 may form a loop extending into the ciliary sulcus, similar to the loop of a three-piece IOL. Figures 10A-10B One embodiment of the stabilization structure 2138 is shown, which includes two open loops configured to extend laterally outward anterior to the thorax 40 to engage with the ciliary sulcus when the anterior surface of the device (i.e., the canopy 2110) abuts against the posterior inner surface of the pouch 35. In some embodiments, the stabilization structure 2138 may be in the form of a loop with a thickness of less than about 0.5 mm that extends into the ciliary sulcus or extends at least a distance along the top of the anterior sulcus.

[0086] The stabilization structure 2138 may also be located on top of the anterior capsule to provide support for the device located behind the anterior capsule. Figure 10C-10D An embodiment of the stabilization configuration 2138 is shown, which includes two lateral protrusions configured to extend laterally outward prior to the tear pouch 40 to engage with the front surface of the pouch 35 when the front surface of the device (i.e., the canopy 2110) abuts against the rearward inner surface of the pouch 35.

[0087] Figure 10A and 10CEach embodiment of the stabilization configuration 2138 shown may have a first portion 2116 and a second portion 2118 coupled to and extending laterally outward from the first portion 2116. The first portion 2116 may be positioned near the edge of the canopy 2110 defining the orifice 2127. The first portion 2116 may project forward a distance from the forward-facing surface of the canopy 2110, thereby defining the dimensions of the space 2142 between the canopy 2110 and the second portion 2118. The projection distance of the first portion 2116 is sufficient to allow the anterior bladder 35 of the pouch to be inserted between the canopy 2110 and the second portion 2118, such that the ruptured bladder 40 engages with the first portion 2116. The first portion 2116 may be an annular structure defining an outer diameter having dimensions suitable for passing through and engaging with the anterior ruptured bladder 40. However, the first portion 2116 need not be a complete annulus. For example, the first portion 2116 may be formed by a plurality of protrusions arranged on or around the opposite side of the orifice 2127. Similar to the optical capture of a conventional cat-eye capsulotomy, the engagement can also occur at only two points. The engagements can be distributed along an arc, for example, approximately 2 mm to approximately 6 mm on each side. The stabilization structure 2138 is sized to be compatible with capsulotomies of various sizes, ranging from approximately 4 mm to approximately 7 mm or from approximately 5 mm to approximately 6 mm. The engagement between the stabilization structure 2138 and the capsulotomy 40 restricts the translational, axial, and rotational movements of the device 2100 in the eye, thereby limiting the movement of the IOL engaged with the device 2100. Once the device is implanted, the second portion 2118 is less likely to penetrate the capsulotomy.

[0088] Once the device 2100 is secured and stabilized relative to the capsulorhexis, the IOL 110 can be passed through the capsulorhexis and the anterior opening 2127 to be positioned within the recess 2104 behind the canopy 2110. To reduce the risk of the IOL 110 passing posteriorly through the device 2100 during surgery, the depth of the recess 2104 between the canopy 2110 and the posterior platform 2105 can be greater than the depth of the recess described for embodiments of devices positioned anterior to the capsulorhexis. Furthermore, the central orifice 2115 can have a smaller diameter than in other embodiments of devices positioned anterior to the capsulorhexis. For example, the central orifice 2115 can have a diameter of approximately 4.5 mm to approximately 5.0 mm to reduce the risk of the IOL 110 passing posteriorly through the central orifice 2115. At least a portion of the posterior platform 2105 can be reinforced or thickened to increase the circumferential strength of the posterior surface and reduce the likelihood of the IOL 110 accidentally passing through the central orifice 2115. The device 2100 is preferably designed to allow the IOL 110 to be easily inserted through the front orifice 2127 and the endoscopic endoscopic insertion, and to prevent the IOL 110 from easily passing through the central orifice 2115 at the rear of the device 2100.

[0089] It should be understood that, relative to Figure 10A-10D Any features described in the device, including the device body configured to be positioned after endoscopic tearing, may be incorporated into any of the various combinations thereof, or vice versa, of other embodiments of the device described herein, including the device body configured to be positioned before endoscopic tearing.

[0090] One or more fixation arms 2120 may be transscleral fixation arms, designed to be noninvasively displaced and held in place solely by their geometry and mechanical properties, i.e., without the need for sutures or adhesives. The displaced portion or anchor 2125 (also referred to herein as an anchoring pad or pad) located at the peripheral end of the fixation arm 2120 (also referred to herein as the end or distal portion) may be located subconjunctivally to anchor the arm 2120 in place. In some embodiments, the conjunctiva may be removed and reformed after displacement. The instrument for implantation may allow both transconjunctival and subconjunctival placement. The anchor 2125 of the fixation arm 2120 may have a robust yet thin geometry to remain stable and prevent re-entry into the eye, and to minimize erosion of the conjunctiva. Furthermore, the fixation arms 2120 of the device 2100 may be manufactured in a manner that facilitates easy observation and manipulation of the device before surgery. At least one of the fixation arms 2120 can be manufactured to have a substantially non-planar geometry when at rest, and then manipulated into a planar shape during implantation (e.g., under tension).

[0091] The device 2100 may include one, two, three, or more fixation arms 2120. In a preferred embodiment, the device 2100 includes three fixation arms 2120 arranged symmetrically or equidistantly around the periphery of the support structure 2105. The fixation arms 2120 can center the lens support structure 2105 and provide sufficient support for long-term stability. In some embodiments, this can be achieved with a single fixation arm 2120. In other embodiments, one or more fixation arms include three fixation arms 2120 arranged symmetrically around the periphery of the lens support structure. The fixation arms 2120 may be made of a semi-rigid material or may have a geometry that provides sufficient structural rigidity.

[0092] The device 2100 may also comprise only two fixation arms 2120. During transscleral implantation and anchoring, these fixation arms 2120 may be under equal and opposite tension. Alternatively, the fixation arms 2120 may be asymmetrical, such that one fixation arm 2120 is under tension while the other has the stiffness and length to function as a rigid spacer element. Rigid or elastic fixation elements may rely on penetration or wedging into place from adjacent tissue. Once placed, tensioned fixation elements may rely on slight stretching or expansion of the material. One or both of the fixation arms 2120 may be manufactured with an inwardly biased configuration, wherein the fixation arm is biased toward a forward-projecting curve or fold configuration, as described elsewhere herein. The fixation arms 2120 may have a paddle-like geometry that prevents rotation when engaged with ocular tissue.

[0093] Device 2100 may also include three or more retaining arms 2120. The three retaining arms 2120 may provide a defined retaining plane for device 2100 that is substantially parallel to the Z-plane (vertical plane) of the eye. The retaining arms 2120 may be designed and deployed such that each retaining arm 2120 is under equal and opposite tension. Alternatively, one or more retaining arms 2120 may be designed to have rigidity and length that allows them to function as rigid spacer elements. Zero, one, two, or all three or more retaining arms 2120 may be manufactured with an inwardly biased design or biased toward the center of the device or the central axis CA of the device (see [link to relevant documentation]). Figure 11A-11F (12A-12C and 13A-13E). The inwardly biased fixation arm 2120 may extend from the support structure and has a folded configuration before implantation. At least one, but not all, fixation arms may be biased or bent as described herein. At least two, but not all, fixation arms may be biased or bent as described herein. In some embodiments, all fixation arms 2120 may be biased or bent. The device may include three fixation arms, wherein two of the three fixation arms are flexible and biased toward a folded configuration, while the third fixation arm is less flexible than the other two fixation arms and biased toward an unfolded configuration. The folded configuration of each fixation arm may bias the distal portion of the fixation arm toward the central axis CA of the device. The lens support structure may be biased toward a substantially flat or planar configuration, while the fixation arms may be biased toward a folded configuration that is not substantially flat or planar.

[0094] With scleral implantation and fixation, the inwardly biased arm can be straightened or unfolded (released) from its folded, inwardly biased configuration. In a preferred embodiment, two fixation arms 2120 have inwardly biased geometry, while a third fixation arm 2120 has an increased cross-sectional area—thus improving its rigidity. The inwardly biased fixation arms 2120 may have bends between the starting point and the end point of the arm having the lens support structure 2105. The two bends in the fixation arms 2120 may be biased toward the central axis CA of the device in the folded configuration.

[0095] In one embodiment, the device 2100 may include at least three fixation arms 2120. In the resting state and before implantation, one of the at least three fixation arms may extend from the support structure in an unfolded configuration, and at least two of the at least three fixation arms may extend from the support structure in a folded configuration. Furthermore, in the resting state before implantation, one of the at least three fixation arms may be biased toward the unfolded configuration, and at least two of the at least three fixation arms may be biased toward the folded configuration. After implantation, each arm biased toward the folded configuration may be unfolded.

[0096] Each fixation arm 2120 may include a starting portion 2103 located at the support structure 2105 and an end portion 2102 coupled to the non-invasive anchor 2125 to achieve seamless transscleral fixation. Prior to transscleral fixation of the anchor 2125, one of the plurality of fixation arms 2120 (up to all fixation arms 2120) may include a bent fixation arm 2120 that bends between its starting portion 2103 and its end portion 2102 to form a bend B (see [link to relevant documentation]). Figure 11A-11F (12A-12C and 13A-13E), enabling direct observation through the pupil 30 of the eye of at least a portion of the bent fixed arm 2120 (see 12A-12C and 13A-13E). Figure 14After the anchor 2125 is fixed via the sclera, each of the plurality of fixation arms 2120 can be tensioned between its starting portion and its end portion to align with the support structure relative to the Z-plane of the eye. The support structure 2105 is adapted to provide support for the intraocular lens. A central aperture 2115 extending through the entire thickness of the support structure 2105 is adapted to allow light to pass through the central aperture 2115 and the IOL supported by the support structure 2105. The bent fixation arms 2120 can be bent forward such that a portion of the arm 2120, such as the end portion 2102 and / or its non-invasive anchor 2125, is positioned over at least a portion of the support structure 2105 (e.g., over the upper surface of the support structure 2105 and / or the area of ​​the central aperture 2115). Alternatively, the curved fixing arm 2120 may be bent rearward such that a portion of the arm 2120, such as the end 2102 and / or its non-invasive anchor 2125, is positioned under at least a portion of the support structure 2105 (e.g., under the lower surface of the support structure 2105 and / or the area of ​​the central orifice 2115).

[0097] Figure 11A-11FFigures 12A-12C and 13A-13E illustrate embodiments of a device 2100 with fixation arms 2120, wherein the fixation arms 2120 are in a stationary state, prior to implantation. Two of the three fixation arms 2120 are bent inward such that they are biased toward a folded configuration when stationary. The arms 2120 extend substantially vertically outward from the support structure 2105, for example from their origin 2103 at the support structure 2105, and turn (forward or backward) to form a bend between the origin 2103 and the end 2102 of the arm 2120. The bend of the arm 2120 allows the end 2102 of the arm 2120 to be closer to its own origin 2103. In some embodiments, the arms 2120 are bent in a forward direction such that the end 2102 of the arm 2120 is positioned before the origin 2103 of the arm, or positioned on at least a portion of the forward-facing surface of the support structure 2105 near the origin 2103 of the arm. In other embodiments, arm 2120 may bend rearward such that the end portion 2102 of arm 2120 is positioned behind the beginning portion 2103 of arm, or below at least a portion of the rearward surface of the support structure 2105 near the beginning portion 2103 of arm. In one embodiment, the anchor 2125 of the bent retaining arm 2120 may be bent away from a first plane (e.g., the Z-plane of the eye) into a second plane parallel to the first plane. The second plane may be before or after the first plane, depending on whether arm 2120 is bent forward or backward. The bend may be in a direction substantially transverse to the plane (e.g., the Z-plane) of the lens support structure 2105 (e.g., the X-plane). The dilated pupil (depending on whether the patient is an adult or a child) may have a diameter of up to approximately 8 mm. The curved portion positions the anchor 2125 of the curved fixed arm 2120 within the diameter of a circle in the second plane, which is visible within the diameter of the dilated pupil, thus not obstructing direct observation of the opaque iris. The diameter is, for example, between approximately 3 mm and approximately 7.5 mm, more preferably approximately 7 mm. The anchor 2125 of each curved fixed arm 2120 can be positioned at a distance from the center of the device, for example, approximately 1.5 mm, 2.0 mm, 2.5 mm, or 3.0 mm from the center of the device, but no more than approximately 3.5 mm or no more than approximately 4.0 mm. The curved arm 2120 is used to position the end portion 2102 and / or the anchor 2125 within the diameter or at a distance from the center of the device for easy observation. The third of the three fixed arms 2120 is biased into a straight or extended configuration when at rest. The third arm 2120 extends vertically outward from its starting point 2103 at the support structure 2105 without turning or bending. Conversely, the entire third arm 2120 is completely straight and extends essentially along a single axis.The two fixed arms, which were biased toward the folded configuration when at rest, are now in the unfolded configuration, for example by tensioning the arms 2120 by means of an outwardly moved transscleral anchor.

[0098] It should be understood that the device 2100 can be directly observed through the pupil even without the fixed arm 2120 or when the fixed arm 2120 is not biased into a folded configuration when at rest. For example, the device 2100 may include one or more centrally projecting structures 2117, such as those located on the canopy 2110 (see [link to relevant documentation]). Figure 18E-18H or Figure 18I-18J During implantation, the user can see the structure. The structure 2117 protrudes sufficiently toward the center of the central opening 2115, for example, at least about 2.5 mm to about 3 mm from the center, so that it is visible through the pupil during implantation.

[0099] The fixed arms 2120 can be evenly distributed around the device 2100 to provide uniform tension. Alternatively, the fixed arms 2120 can be arranged in a non-uniform manner; for example, three fixed arms 2120 can be arranged at 90 degrees to each other. In this case, two fixed arms 2120 will be separated from each other by 180 degrees, thus providing opposing tensions; while the third fixed arm 2120 is mainly used to prevent the device 2100 from rotating.

[0100] Each retaining arm 2120 may have a spring force that is a function of the amount of elongation of the material under load. Conversely, an open loop or coil spring may have a spring force provided by the bending of a material having a substantially fixed length. Once anchored in the eye, the retaining arms 2120 may be subjected to tensile stress and material elongation. For example, each retaining arm 2120 may extend in a radius of approximately 7.5 mm to 8.0 mm to accommodate a diameter of approximately 15 mm to approximately 16 mm. The device has an operable tension range for operation. For example, once implanted, the device may be under a first magnitude of tension (X tension). The first magnitude of tension is the tension value at the minimum acceptable diameter. In other words, the device is designed to operate under a minimum magnitude of tension but can be placed under greater tension to accommodate larger diameters. In the example of retaining arms 2120 capable of accommodating elongations of 15 mm and 16 mm, each force-transmitting arm is capable of operating under the first tension X and at least one second tension. The second tension can be the sum of the first tension x plus the tensioning distance (e.g., 0.5 mm tensioning distance). The fixed arm can withstand the differential tension at each elongation ratio. To further illustrate this example, if each fixed arm 2120 in this embodiment is approximately 4 mm long, the second tension (x tension + 0.5 mm tensioning distance) may experience a 12.5% ​​increase in elongation, thus enabling operation at a diameter of 15 mm and also at a maximum diameter of 16 mm. If the fixed arm 2120 in this example is 2 mm long, the second tension (x tension + 0.5 mm tensioning distance) may experience a 25% increase in elongation, thus enabling operation at a diameter of 15 mm and also at a maximum diameter of 16 mm. If the fixed arm in this embodiment is approximately 6 mm long, the second tension (x tension + 0.5 mm tensioning distance) may experience a 6.25% increase in elongation, thus enabling operation at a diameter of 15 mm and also at a maximum diameter of 16 mm. The reduced elasticity of the fixation arm 2120 enhances the safety and functionality of the device because the tension of the anchor on the ocular tissue is less dependent on variables that are difficult for surgeons to assess—the inherent size of the eye and the specific location of the incision. Furthermore, the length of the fixation arm (e.g., between approximately 2 mm and 6 mm) and the inward bending (forward or backward) of at least one or more fixation arms 2120 improve accessibility and observability, making it easier for surgeons to locate and fix the arm during surgery. The device can have a fixation diameter D in a relaxed state. d The diameter is between approximately 15 mm and approximately 20 mm, preferably between approximately 16.50 mm and approximately 18.00 mm, wherein the radius of the circle is measured from the center of the central aperture 2115 to the inward-facing surface of the anchor 2125 of the straight fixing arm 2120 (see...). Figure 18E ).

[0101] The end plate or anchor 2125 of the fixation arm 2120 may be coupled to or positioned at the outer end of the fixation arm 2120. The anchor 2125 may have various geometries designed to facilitate external removal by a surgeon and to stabilize tension on the device throughout its lifespan. The anchor 2125 may have a generally thin profile and may have geometries designed to limit conjunctival erosion and eyelid irritation (e.g., rounded). The end of the fixation arm 2120 may have an anchor 2125 configured to be positioned outside the sclera 20 to secure the lens support structure 2105 and prevent centripetal slippage. The geometry of the anchor 2125 allows the surgeon to pass the anchor 2125 through a perforation or incision in the sclera 20 using forceps, cannulas, ferrules, or other surgical instruments, including a ferrule device for removing the anchor as described in U.S. Patent No. 10,973,624, which is incorporated herein by reference. Anchor 2125 may have a geometry similar to a nail head, a T-bar, a forked shape, or any other geometry capable of preferentially passing through the sclera 20 in a first direction and preventing pull-out from the insertion direction to maintain its external position when the arm 2120 is under expected tension throughout the lifespan of the device. Anchor 2125 is designed to have a profile and geometry that will not irritate the eyelids or conjunctiva throughout the lifespan of the device 2100. Therefore, the preferred geometry will have a minimal thickness profile with smooth, rounded, and / or gradually decreasing edges. Anchor 2125 may have a substantially constant thickness or may have a thickness that varies along its length, as discussed in more detail below.

[0102] The anchor 2125 described herein is configured to be easily moved outward and resist re-inward movement after outward movement. Anchors can be designed so that they can be gripped with ophthalmic tools (e.g., size 23, 25, or 27 tools). Geometry that is ideal for gripping with ophthalmic tools may not be ideal for secure fixation. Figures 16A-16CFurther geometry of the anchor 2125 with variations in thickness, width, and / or height is shown. The anchor 2125 may include a central portion 1255 and one or more grippable portions 1257 located at the periphery of the central portion. The central portion 1255 may be positioned over the wound where the anchor 2125 is inserted (sclerotomy), while the grippable portions 1257 are positioned adjacent to the wound. Compared to the peripheral grippable portions 1257, the central portion 1255 may have increased thickness, height, and / or width. The increased thickness, height, and / or width of the central portion 1255 can increase the volume of the area over the wound, thereby reducing the likelihood that tension on the fixation arm will pull the anchor 2125 back through the wound. The thickness Tc of the central portion 1255 of the anchor 2125 along the longitudinal axis L of the arm 2120 may be greater than the thickness Tg of the grippable portions 1257. For example, the thickness Tc can be approximately 1.2 to 5.0 times the thickness Tg of the gripper portion 1257. In other embodiments, the width or height of the central portion 1255 can be approximately 1.2 to 5.0 times the width or height of the gripper portion 1257. The geometry of the larger area is designed to resist deformation under tension associated with normal use of the device. During outward movement, the larger central portion 1255 can collapse inward to fold over the end of the arm 2120 to which the central portion 1255 is attached. Once the arm 2120 is under tension, the larger central portion 1255 cannot fold away from the end of the arm 2120 onto itself, which prevents the outwardly moving anchor 2125 from being pulled back through the wound. Thus, although the central portion 1255 has a larger volume, it can be pulled across the wound in a first direction (outward from the eye), but its larger volume prevents it from being pulled across the wound in the opposite second direction (inward toward the eye).

[0103] The gripping portion 1257 may include any of a variety of shapes, including oval, rectangular, star-shaped, or other shapes or geometries that improve the gripping ability of the gripping portion 1257 compared to the central portion 1255. The gripping portion 1257 may have a thinned and narrow tab extending from the central portion 1255. Each anchor 2125 may include 1, 2, 3, 4, 5, 6 or more gripping portions 1257 to allow a user to grip the anchor, regardless of the construction of the device.

[0104] In some embodiments, each fixation arm 2120 may have more than one anchor 2125. The device 2100 may have three fixation arms 2120, each with a first anchor 2125 at its end and a second anchor 2125 located within 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 can be moved outward through the sclera 20 such that it also holds the device 2100 in place. Each fixation arm 2120 may include multiple anchors 2125 arranged along its length. The multiple anchors 2125 may include two, three, four, five, or more anchors 2125 evenly spaced along its length. The surgeon can move as many anchors 2125 outward as needed to center the device 2100. Excess material around the outer anchor 2125 closest to the sclera 20, including the fixation arm 2120 and the anchor 2125, can be removed, for example, by trimming. Trimming material from the device, such as one or more of the fixation arms 2120, the anchors 2125 of the arms, etc., allows for immediate customization to the patient's eye. In some cases, such as when the fixation arm 2120 has multiple anchors 2125 that are displaced through the sclera, additional anchors 2125 performing the anchoring function (as well as a section of the arm 2120) can be removed from the periphery of the anchors 2125. Therefore, multiple anchors 2125 of each fixation arm 2120 can allow the surgeon to adjust the size of the device 2100 according to the patient's eye during surgery. Trimming the anchors 2125 that are displaced through the sclera and / or the outer portion of the fixation arm 2120 allows for immediate customization or adjustment of the length of the fixation arm 2120. The surgeon may also determine that only one of the multiple fixation arms 2120 is needed for a particular implantation procedure. The surgeon can trim away unnecessary arms 2120 before implanting the device into the eye. For example, the surgeon may decide to trim away bent arms before implantation, leaving only straight arms for tethering relative to the sclera. In one embodiment, the device 2100 has multiple fixation arms 2120. Once the device 2100 is implanted into the eye and at least some fixation arms 2120 are selected to provide stability of the device within the eye, one or more remaining fixation arms 2120 that are unnecessary for stability can be trimmed from the device 2100 and removed from the eye. Therefore, the length and number of fixation arms 2120 of the device 2100 can be customized in real time during implantation.

[0105] The two anchors 2125 on a single fixation arm 2120 can have different external dimensions, with the inner anchor 2125 being narrower than the outermost anchor 2125. It should be understood that multiple anchors 2125 on a single fixation arm 2120 can also have the same dimensions, and it is not necessary to change their dimensions. The anchors 2125 can also have geometry that improves their passage through the sclera in a first direction but weakens their passage through the sclera in the opposite second direction. For example, the anchors 2125 can incorporate square edges. However, the anchors 2125 can have square edges on the inward-facing surface and smooth, gradually decreasing edges on the outward-facing surface, which facilitates their passage through the sclera in the outward direction.

[0106] The fixation arms 2120 extending to the eye wall may be difficult to manipulate because they may be obscured by the peripheral iris 10, limbus, and sclera 20. As described above, one or more of the fixation arms 2120 can be biased inward toward a folded configuration so that they can be seen directly through the pupil (see [link to documentation]). Figure 14 Each fixing arm 2120 initially extends outward from the support structure 2105 in an orthogonal direction, then bends or folds forward (or backward) such that the end 2102 of the fixing arm 2120 (or at least a portion of the anchor 2125) is positioned over the fixing arm 2120, the support structure 2105, or at least a portion of the central aperture 2115 extending through the support structure 2105. At least a portion of the bent fixing arm (i.e., the end and / or the anchor 2125) is more easily observed through the dilated pupil, and observation is not obstructed by the opaque iris 10 (see...). Figure 14 This inward (centripetal) bias also allows the bent retaining arm 2120 to be securely gripped and manipulated during implantation of the device. Each retaining arm 2120 of the device 2100 may have an inward bias toward a folded configuration, or only selected retaining arms 2120 may have an inward bias (e.g., one, two, but not all of the retaining arms 2120).

[0107] The fixed arm 2120 can also be molded to have a bend or curve between its starting point and end anchor 2125, which has a lens support structure 2105 (see...). Figure 11A-11F 12A-12C, 13A-13E and Figure 15The bent fixation arm 2120 can be biased toward a folded configuration. For example, one or more of the fixation arms 2120 can be bent 90 to 270 degrees in both radial and centripetal directions from their origin having the lens support structure 2105. Thus, the end 2102 of the bent fixation arm 2120 lies in a plane different from the plane of the lens support structure 2105. When at rest before being positioned in the eye, the end 2120 of the first fixation arm 2120 of at least a plurality of fixation arms 2120 can have a bend B combined between its origin 2103 having the lens support structure and its end 2102, thereby forming a bent arm. The bent arm can extend at least a first distance from its origin orthogonal to the lens support structure 2105. The bent arm can then bend upward (forward) at least another distance away from the plane of the lens support structure 2105. The bent arm 2120 can then bend back toward its origin or toward the central axis CA of the device. This allows the end of the flexion arm 2120 to lie in a plane different from the plane of the lens support structure 2105. The bend or flexion in the arm 2120 can project outwards away from the central axis CA and away from the arm's origin 2103 and end 2102. The end portion of the arm 2120, via the scleral anchor 2125 and / or the fixed arm 2120, can be positioned above or before at least a portion of the lens support structure 2105, or above at least a portion of the central aperture 2115. Alternatively, the flexion arm 2120 can be bent downwards (backwards) at least a distance away from the plane of the lens support structure 2105, and the end portion of the arm 2120, via the scleral anchor 2125 or 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 aperture 2115. The folded configuration (whether the arm 2120 bends forward or backward) allows at least a portion of the bent fixed arm 2120 (e.g., the end of the bent fixed arm 2120) and / or their anchors 2125 to be visible through the pupil and unobstructed by the opaque iris. Only one arm 2120, two arms 2120, or all of the fixed arms 2120 may be combined with a bend. Alternatively, no fixed arm 2120 may be combined with a bend (see [link to relevant documentation]). Figure 18I-18J ).

[0108] Once the device is positioned and anchored in the eye, the fixed arm 2120 is placed under tension, causing the bending arm to unfold from the folded configuration and cease bending. The end of the arm 2120 is propelled out of this static state of the folded configuration, thereby causing the bent fixed arm to enter a straight or unfolded configuration.

[0109] The bend B in the folded configuration can be a gradually smooth bend with a radius of curvature, or it can be bent to form one or more different angles along the length of the arm 2120. The bend can be compact enough to avoid protruding too far forward, while still being relatively easy to unfold or place in an unfolded configuration without exerting excessive stress on the lens support structure 2105. The inwardly biased geometry can have a radius of curvature between approximately 0.10 mm and approximately 2.5 mm on the inner bend (the anterior-facing side) and a radius of curvature between approximately 0.6 mm and approximately 3.0 mm on the outer bend (the posterior-facing side). In one embodiment, the end of the inwardly biased fixation arm can be spaced apart from the lens support structure 2105 to form a gap G (see [link to relevant documentation]). Figure 13D-13E The gap G can be between approximately 0.2 mm and approximately 2.5 mm. In one embodiment, the biased fixation arm 2120 bends 180 degrees with a full radius and has an inwardly biased geometry having a radius of curvature of approximately 0.63 mm on the inner bend and approximately 1.13 mm on the outer bend, such that the lens support structure 2105 is spaced approximately 1.25 mm from the biased fixation arm. The starting point of the bend (near the starting point 2103 with the lens support structure 2105) and the ending point of the bend (near the ending point 2102 at the scleral anchor 2125) can have multiple radii, such that the bend varies along the length of the fixation arm 2120. The bend of the biased fixation arm 2120 can have an average curvature between approximately 0.15 mm and approximately 2 mm on the inner bend.

[0110] After implantation and before fixation to the scleral wall, the bent fixation arm 2120 is in a stress-free (static) state (see...). Figure 14The fixation arm 2120 is visible through the pupil. This visibility allows the surgeon to easily engage the anchor 2125. While engaging the fixation arm 2120 by grasping the body of the anchor 2125, the surgeon can unfold the fixation arm 2120 from its resting folded configuration so that it is substantially coplanar with the lens support structure 2105. These fixation arms 2120 can be flexible such that the stress stored in the material in the deployed (or unfolded) state does not exert torsional or tensile forces on the lens support structure 2105 in a manner that impairs the function of the device. The fixation arm 2120 can be molded to rotate 90–270 degrees tangentially and centripetally from its lens support origin. The fixation arm 2120 can incorporate a resilient material or deformable hinge to facilitate this manipulation without substantially altering the geometry of the lens support structure 2105. The fixation arm 2120 has a length such that when the fixation arm 2120 is bent back 180 degrees toward its starting point having the lens support structure 2105, the end 2102 of the fixation arm 2120 can be positioned on at least a portion of the lens support structure 2105. Each fixation arm 2120 of the device 2100 may have a bending portion, or only selected fixation arms 2120 may have a bending portion (e.g., one, two, but not all of the fixation arms 2120). Figure 11A-11F Figures 12A-12C and 13A-13E show two fixation arms 2120 having a bend B, and one fixation arm is substantially coplanar with the plane of the lens support structure 2105.

[0111] One or more of the fixation arms 2120 of the device described herein may be manufactured to have a non-planar geometry when at rest and may be biased toward a folded configuration, making at least a portion of the fixation arm 2120 easily visible through the pupil after the device 2100 has been implanted but before the anchor 2125 has moved outward. Fixation arms 2120 with this configuration are easier for the user to grasp and manipulate, thereby facilitating their deployment into an unfolded configuration for seamless fixation. Fixation arms 2120 manufactured to be biased in a resting state or bent or flexed in a resting state include fixation arms 2120 having this shape when the device 2100 is outside the eye and ready for implantation. In some embodiments, fixation arms 2120 may be in a bent, folded, or flexed shape after implantation into the eye (e.g., the posterior chamber) but before the anchor is secured. For example, one or more fixation arms 2120 may be formed of a material that has a first shape when outside the eye, presents a curved shape different from the shape of the arm 2120 before it is implanted into the eye, and is able to unfold into a substantially straight shape when the anchor 2125 is moved outward.

[0112] The fixation arm 2120 has an offset toward a folded or bent shape (e.g., having a bend along its length between its starting portion 2103 and its end portion 2102), allowing the fixation arm 2120 to be seen through the pupil, grasped, and manually unfolded and / or stretched to secure the anchor 2125 of the arm 2120 transscleral. The configuration and / or radius of curvature of the bend, bend, or fold, as well as the orientation of the bend, bend, or fold, can vary as long as at least a portion of the fixation 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 through the patient's dilated pupil. In some embodiments, this means that at least a portion of the fixation arm 2120 is positioned over at least a portion of the lens support structure 2105 and is positioned radially inward of its outer region 2111. The distance of the portion of the arm 2120 extending radially inward of the outer region 2111 can vary. This portion can extend above a location adjacent to the outer region 2111, a location not above the outer region 2111 in orientation along the central axis CA extending from front to back through the central opening 2115. In this embodiment, the distance between the central axis CA of the device and the portion extending above is greater than the distance between the central axis CA of the device and the outer region 2111. The portion can extend above the outer region 2111. In this embodiment, the distance between the central axis CA of the device and this portion is equal to the distance between the central axis CA of the device and the outer region 2111. This portion can extend above a location radially inward of the outer region 2111. In this embodiment, the distance between the central axis CA of the device and this portion is less than the distance between the central axis CA of the device and the outer region 2111. This portion can extend above the central opening 2115. In this embodiment, the distance between the central axis CA of the device and this 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 can be coaxial with the center of the central opening 2115.

[0113] A portion of the fixation arm (e.g., end 2102 and / or anchor 2125) may be positioned on a portion of the lens support structure 2105 and also on a portion of the central opening 2115. For example, the anchor 2125 may be sized such that at least a portion of the anchor 2125 is positioned on at least a portion of the lens support structure 2105, while another portion of the anchor 2125 is positioned on at least a portion of the central opening 2115.

[0114] The fixed arm 2120, biased toward a curved configuration, may be bent toward the interior or central portion of the device, including but not limited to the actual center of the device or the center of the central axis CA or the center of the central aperture 2115. The center of the device 2100 is the center of the circle formed by the central aperture 2115 (if the central aperture 2115 is circular). The central axis CA of the device extends through the center of this circle in the front-rear direction (i.e., the up-down direction). If the central aperture 2115 is substantially non-circular, the center of the device is the center of symmetry of the central aperture 2115 along the central axis CA extending in the front-rear direction. Fixed arms biased into a folded or curved configuration such that their anchors extend toward the center of the device or toward the central axis CA of the device are not required to have the axis of the anchor passing through the arm intersecting the actual center or the central axis CA of the device. "Towards the center" or "towards the central axis" relative to an inwardly biased fixation arm includes an arm having a curved portion that extends back towards a portion of the device in a generally inward direction, as opposed to the end of a straight fixation arm, which extends in a generally outward direction away from the lens support structure. The curved fixation arm can be biased towards any central portion of the device, and does not necessarily have to point directly to the actual center of the device. The curved fixation arm can be at an angle relative to the actual center.

[0115] The device may include at least a number of retaining arms extending back toward the center of the device. Device 2100 may include a lens support structure 2105 and three retaining arms 2120. Two retaining arms 2120a, 2120b may be biased into a folded configuration, with a bend B between the arm's starting point 2103 and its end point 2102. A third retaining arm 2120c may be substantially straight and without a bend B between its starting point 2103 and its end point 2102, thus extending substantially orthogonally relative to the lens support structure 2105 along a single axis L. Anchors 2125 of each retaining arm 2120a, 2120b may project back toward the center of the device. The anchors 2125 of the retaining arms 2120a, 2120b may have at least one first portion overlapping at least a portion of the lens support structure 2105 and / or at least one second portion overlapping at least a portion of the central opening 2115. An axis can be drawn through the anchor 2125 of each arm 2120a, 2120b, showing the direction in which the anchor 2125 protrudes from the bend B between the arm's starting point 2103 and the arm's end 2102 and towards the center of the device. The axis of the arm may, but does not necessarily, intersect the central axis CA. Therefore, the arm can be biased toward a folded configuration in which the anchor protrudes back toward the center of the device, but does not necessarily have to extend along an axis intersecting the central axis CA or the actual center of the device.

[0116] When the fixation arm is described as "folded," "bent," or "curved," or has a "folded," "bent," or "curved" configuration, the angle of the fixation arm along its length relative to the longitudinal axis can vary gradually and uniformly, or it can vary more abruptly or suddenly, thus forming an angle. A folded configuration can describe the fixation arm being inwardly biased when at rest or before implantation, wherein the fixation arm extends outward from the support structure along a first axis and bends back towards the central portion of the device relative to the plane of the support structure, either forward or backward. Upon implantation, the support structure of the device is configured substantially parallel to the Z-plane (vertical plane) of the eye. A folded configuration can include a geometry in which the fixation arm bends away from this plane of the support structure (e.g., in a transverse plane), such that at least a portion of the fixation arm is positioned in front of another portion of the device (e.g., above itself, the lens support structure, and / or the central opening). A folded configuration does not necessarily mean that the portions of the fixation arm overlap and also contact each other. Preferably, the portions of the fixation arm are spaced apart by a distance along the central axis CA of the device. A folded configuration also does not necessarily mean a crease or a sharp angle of folding. A folded configuration can mean that there is a radius of curvature between the start and end of the fixed arm at the support structure.

[0117] The folding configuration may also include fixation arms that bend within the plane of the lens support structure rather than away from it. Anchors 2125 of each fixation arm 2120a, 2120b may project inward from the bend B of the arm, such that the anchors 2125 remain substantially in the same plane as the lens support structure. An axis can be drawn through the anchors 2125 of each bend in the arm 2120a, 2120b, showing the direction in which the anchors 2125 project away from the bend B between the arm's starting point 2103 and its end point 2102 and towards the center of the device. Fixation arms 2120a, 2120b biased toward the folding configuration may have anchors 2125 projecting towards the center of the device. The axis of arm 2120 may, but does not necessarily, intersect the central axis CA.

[0118] The portion of arm 2120 positioned above at least a portion of support structure 2105 may include a portion positioned above and radially inward of the outer region 2111 of support structure 2105. This portion of arm 2120 positioned above at least a portion of support structure 2105 may include a portion positioned radially inward and above the central opening 2115. In these cases, "radially inward" does not necessarily mean in the same plane. Preferably, this portion of arm 2120 is positioned above a portion of support structure in a plane different from the plane of support structure. This portion of fixing arm 2120 (e.g., anchor 2125 and / or end 2102) may terminate before or after lens support structure 2105 at a diameter located at the center of the outer periphery of lens support structure 2105. This portion may lie above a portion of lens support structure relative to the central axis CA extending forward and backward through the central opening 2115 of the device. In the case where a portion of the fixation arm 2120 is described as being located above a portion of the lens support structure, that portion of the fixation arm 2120 may also be located above the central opening 2115 defined by the lens support structure 2105.

[0119] When a portion of arm 2120 is described herein as being “above” another portion of device 2100 (e.g., itself, lens support structure 2105, and / or central opening 2115), that portion of arm 2120 may generally overlap with the portion of the device in space and does not require a specific orientation relative to the retina. Therefore, “above” herein is generally used to mean overlapping in the space surrounding the device, and may, but not necessarily, require that spatial overlap be in a generally forward orientation relative to the retina. A portion described as being “above” another portion may be positioned behind the other portion relative to the retina during use. An arm 2120 biased into a folded configuration is referred to herein only as being “above” or “overlapping” another portion of the device, even if it may be positioned “above” or “behind” the other portion of the device relative to the retina during use. For simplicity, each alternative may not be described repeatedly in each case throughout the disclosure. The arm may be bent such that at least a portion of the arm is positioned on the forward-facing portion of the device, such that portion is generally arched over the device along the central axis CA. The arm can be bent such that at least a portion of the arm is on the rearward portion of the device, thus forming a generally arched shape below the device along the central axis CA. The arm can be bent such that at least a portion of the arm is in the same plane, so that it is neither on the forward nor the rearward portion of the device. Any of several configurations of the fixed arm are considered here, such that at least a portion of the arm is visible through a dilated pupil. These mechanisms can be varied, utilizing which the fixed arm 2120, bent towards a folding configuration, unfolds to present a flat configuration. These arms can unfold under mechanical, electromagnetic, and / or thermal action.

[0120] In some embodiments, the fixation arm 2120 can be mechanically deployed along a single axis of the arm. The fixation arm 2120 does not need to be biased into a folded configuration with bends or curves when at rest. For example, the fixation arm 2120 can be biased into a folded configuration where the arm 2120 is longitudinally compressed along a single axis. The arm 2120 extends orthogonally outward from the lens support structure along the single axis between its starting portion 2103 and its ending portion 2102. In the folded configuration, the length of the arm 2120 between its starting portion 2103 and ending portion 2102 can be shorter, such that the anchor 2125 of the arm 2120 is more centrally located within a smaller diameter than in the deployed configuration. After the device is implanted in the eye but before the anchor 2125 moves outward, the arm 2120 can be telescoped outward to extend its length, allowing it to be moved outward. Mechanical deployment by telescoping can be achieved by the sliding of the nested components of the arm 2120 onto each other to provide a greater length when deployed or a shorter length when folded. Mechanical unfolding via telescoping can also be achieved by a single elastic element being configured to fold itself into a shorter length for observation through the pupil, and unfold into a longer length from itself during outward movement.

[0121] In some embodiments, the fixing arm 2120 can be unfolded or folded under thermal action. For example, the fixing arm 2120 can be in a first shape (folded or flat) at room temperature and change into a second shape at or near body temperature (heated to 35°C). This can also be achieved by chemical methods (e.g., hydration) or mechanical methods (cutting the restrictive structure).

[0122] The fixation arm 2120 can be made of elastic or inelastic materials. For example, the fixation arm 2120 can be formed of an inelastic material and have a three-dimensional shape that provides elasticity. This three-dimensional shape can vary as described elsewhere herein, including C-shaped, Z-shaped, S-shaped, or other three-dimensional shapes. The fixation arm 2120 provides sufficient support to hold the IOL 110 or other device without applying excessive force to the scleral tissue. An optimal design will have a wide range of operability for tension and stability to meet both parameters in different sized eyes and incision locations. One way to modify the fixation arm design is to incorporate spring-like structures. These structures can include conventional compression-type loop designs such as J-loops, C-loops, closed loops, Kellman loops, plate loops, or other loop designs common to IOLs. Alternatively, the device 2100 can incorporate tension-type loops, such as simple straight elastic cords. Alternatively, the tension design can be modified to have a V-shaped, Z-shaped, or S-shaped configuration to reduce the tensile resistance of the fixed arm 2120.

[0123] The fixation arm 2120 may have a texture or construction that allows it to be pulled across the sclera in one direction but provides resistance in the opposite direction, in order to minimize the chance of slippage of the fixation arm 2120. The texture or construction may be provided by the material itself or designed into the fixation arm 2120. For example, the fixation arm 2120 may be barbed and formed from a material integrated into an external structure. In this way, the barbed internal structure can function as barbs while concealing the sharp edges typically associated with barbs. An example is a rigid plastic structure embedded in a soft, elastic structure.

[0124] The fixed arm 2120 can be formed from a flexible material that has shape memory and is not stretchable. The flexible material of the fixed arm 2120 can include any of a variety of elastomers, including polyurethane, hydrophobic acrylic resin, hydrophilic acrylic resin, nylon, polyimide, PVDF, natural polyisoprene, cis-1,4-polyisoprene natural rubber (NR), trans-1,4-polyisoprene gutta-percha, synthetic polyisoprene (IR represents isoprene rubber), polybutadiene (BR represents butadiene rubber), chloroprene rubber (CR), polychloroprene, chloroprene, Bayer, etc., butyl rubber (a copolymer of isobutylene and isoprene, IIR), halogenated butyl rubber (chlorinated butyl rubber: CIIR, brominated butyl rubber: BIIR), styrene-butadiene rubber (a copolymer of styrene and butadiene...). Polymers, SBR), nitrile butadiene rubber (a copolymer of butadiene and acrylonitrile, NBR, also known as BunaN rubber), hydrogenated nitrile butadiene rubber (HNBR) Therban and Zetpol, EPM (ethylene propylene rubber, a copolymer of ethylene and propylene) and EPDM rubber (ethylene propylene diene monomer rubber, a terpolymer of ethylene, propylene and diene components), epichlorohydrin rubber (ECO), polyacrylic acid rubber (ACM, ABR), silicone rubber (SI, Q, VMQ), fluorosilicone rubber (FVMQ), fluorinated elastomers (FKM and FEPM) Viton, Tecnoflon, Fluorel, Aflas and Dai-El, perfluorinated elastomers (FFKM) Tecnoflon PFR, Kalrez, Chemraz, Perlast, polyether block amide (PEBA), chlorosulfonated polyethylene (CSM), (Hypalon), ethylene-vinyl acetate (EVA), thermoplastic elastomers (TPE), arthropod elastin and elastin, polysulfide rubber and polyolefin elastic fibers.

[0125] Arm 2120, made of a flexible material formed into a certain shape, can be bent from the formed shape but has the memory to return to the formed shape. In other words, the flexible fixed arm 2120 can be bent or unfolded from its folded configuration, but cannot be forced to maintain another different shape without some kind of anchoring. For example, one or more of the flexible fixed arms 2120 can be formed into a bent shape. For example, the arm may include a 180-degree bend or curve from its starting point 2103 with support structure 2105 to its end point 2102 near anchor 2125. When the device is at rest and no force is applied to the arm 2120, the arm 2120 can maintain this bent shape such that the arm 2120 is biased toward the folded configuration. In other words, the arm 2120 is bent in its unbiased state. The bent fixed arm 2120 can be bent from this bent shape to present a straight shape or unfolded configuration such that the entire arm 2120 extends and is straight relative to the longitudinal axis l. When bent into a straight shape, arm 2120 is biased to return to the bent shape or folded configuration. If the bending force on the fixed arm 2120 is released, arm 2120 returns to its stationary bent shape. However, in use, the fixed arm 2120 is anchored via the sclera, and the anchor 2125 at the end 2102 of the arm 2120 is located outside the sclera. Arm 2120 is tensioned to maintain a straight shape.

[0126] In other embodiments, the fixation arm 2120 may be formed of or incorporated with a ductile material, allowing the fixation arm 2120 to be bent or formed into a specific shape. The ductile fixation arm 2120 may be formed, for example, of implantable-grade metallic or plastic materials, including gold, silver, platinum, stainless steel, nickel-titanium alloys, nickel, titanium, polypropylene, polyethylene, nylon, PVDF, polyimide, acetal, and PEEK. The material of the fixation arm 2120 is configured to be cut and removed from the device 2100 during implantation, as described elsewhere herein.

[0127] One or more retaining arms 2120 may have a Young's modulus of less than about 1000 MPa, or less than about 500 MPa, or less than about 250 MPa, or less than about 100 MPa, or less than about 50 MPa, or less than about 25 MPa. One or more retaining arms 2120 may have a Young's modulus of less than about 20 MPa, for example, between about 0.01 and about 1.0 MPa. The retaining arms 2120 may be very flexible and apply very small forces because they are designed to anchor the support structure 2105 under tension, rather than having the compressive elasticity used to anchor the support structure 2105 or the more rigid penetrating force that barbs or other retaining loops can provide.

[0128] In some embodiments, each fixation arm 2120 may have a length of approximately 2 mm to approximately 6 mm between the starting point 2103 and the ending point 2102. Each fixation arm 2120 may have the same length. The length of the fixation arm 2120 extending through the sclera may have a minimized thickness or width to reduce the overall size of the wound traversed by the arm 2120. The maximum width of the portion of the fixation arm traversing the sclera near the ending point 2120 where the anchor 2125 is located may not exceed approximately 2.0 mm, approximately 1.5 mm, approximately 1.0 mm, 0.75 mm, or 0.50 mm.

[0129] Figure 11A-11F Figures 12A-12C and 13A-13E illustrate embodiments of a device 2100 having two inwardly biased fixed arms 2120a and 2120b and a third fixed arm 2120c that is not inwardly biased and is straight. Furthermore, the third fixed arm 2120c may have a geometry that makes it less flexible than the other fixed arms 2120a and 2120b. The third fixed arm 2120c may have a wider region with a larger cross-sectional area than the other two fixed arms 2120a and 2120b between its starting point 2103 and its ending point 2102. Figures 16A-16C and Figure 17 The wider area of ​​the fixed arm 2120 is shown. Figure 16B It is shown that the width W1 of the arm 2120 near the end 2102 can be smaller than the width W2 of the arm 2120 away from the end 2102. The width W2 of the arm 2120 away from the end 2102 can provide a certain degree of volume and stability, while the width W1 near the end 2102 can minimize the transscleral portion of the arm 2120.

[0130] During the surgical procedure, one fixation arm 2120a, 2120b, 2120c can be positioned at a time. As described elsewhere herein, the anterior fixation arm 2120c can be straight, while the posterior fixation arms 2120a, 2120b can be curved. The weight of the device can cause the first implanted or the anterior fixation arm 2120c to bend after lateral displacement, causing the device 2100 to tilt posteriorly toward the retina. In this case, the surgeon can position the device further posteriorly. However, since the instrument is being manipulated near the retina, this may increase the risk of intraoperative tissue damage. In some embodiments, the anterior fixation arm 2120c can be reinforced mechanically and / or geometrically to reduce the likelihood of posterior drift. The anterior fixation arm 2120c can be made of a material resistant to such deformation. The material can be any implantable-grade plastic or metal capable of cantilevering the device after lateral displacement of the anchor 2125 of the anterior fixation arm 2120c. Suitable materials include, but are not limited to, PMMA, hard silicone resin, nylon, hydrophilic and hydrophobic acrylic resins, PEEK, polyimide, stainless steel, titanium, nickel-titanium alloys, etc. A more rigid material can be used to form the entire front retaining arm 2120c or only a portion of the front retaining arm 2120c. The front retaining arm 2120c can be formed from a softer material in which the more rigid material is embedded. In one embodiment, the front retaining arm 2120c may include a mechanically reinforced region 1205 located between its starting point 2103 at the support structure 2105 and its end point 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 plastic segment into a softer material. Figure 17 The increased thickness (arrow T) at the mechanically reinforced region 1205 is shown compared to the thickness of the arm near its starting point 2103 with its supporting structure (arrow O). Region 1205 may be spaced apart from the support 2105, for example, near or adjacent to the anchor 2125. Region 1205 may have an increased thickness designed specifically to reduce the likelihood of the device 2100 drifting backward without affecting the ability of the anchor 2125 of the outward-moving fixation arm 2120. For example, the fixation arm 2120 may have a gradually decreasing (or tapered) thickness designed to limit backward deflection. This gradually decreasing geometry is thinnest near the pad anchor 2125 and thickens towards the center. The fixed rear surface can be used to bias the device forward relative to the eye. The contact angle between the rear surface of the fixation arm 2120 and the wound can bias the device 2100 in a manner that reduces the actual risk of backward deflection of the fixation arm 2120. The additional volume further restricts the device's deflection and approach to the retina.

[0131] Figures 12A-12CAnother embodiment of the device 2100 with a circular central aperture 2115 and a non-circular outer periphery 2111 is shown. Figures 12A-12C The non-circular outer periphery 2111 of the lens is a rounded rectangle with two generally flat long sides 2108 and two generally rounded short sides or side lobes 2107. Recesses 2104 formed by the canopy 2110 can protrude over the anterior surface of the lens support structure 2105, such that they are arranged generally opposite to each other and spaced apart along the long axis of the rectangle to accommodate the span of the loop 114 of the IOL 110. For example, the canopy 2110 can protrude outwards on the short side of the rounded rectangle (i.e., at the location of the side lobes 2107) over the anterior surface of the lens support structure 2105 to accommodate the span of the IOL 110 located between them within the recesses 2104 along the long sides 2108 (see [link to relevant documentation]). Figure 12C ).

[0132] Three fixation arms 2120 can be coupled to the lens support structure 2105. As described elsewhere herein, at least one of the fixation arms 2120a, 2120b can be biased into a folded configuration. One fixation arm 2120c can be a front fixation arm extending along a single axis orthogonal to the lens support structure 2105, such that its end 2102 coupled to the anchor 2125 projects outwardly away from the central axis CA of the orifice 2115. The front fixation arm 2120c can be coupled to the lens support structure 2105 at a convex angle 2107, while the other fixation arms 2120a, 2120b can be coupled away from the convex angle 2107 of the front fixation arm (e.g., on the opposite side 2108), such that the opposite convex angle 2107 projects outwardly between the arms 2120a, 2120b (see [link to documentation]). Figure 12A-12B ).

[0133] Figure 15A related embodiment of the device 2100 with a canopy 2110 is shown. The device 2100 also incorporates a plurality of buffers 2114 to help center the device 2100 within the eye. The device 2100 may include four buffers 2114 projecting outward from each corner of the lens support structure 2105. The buffers 2114 may be generally annular or incomplete rings with a C-shape. The annular buffer 2114 may include a first end and a second end, both coupled to the lens support structure 2105. The C-shaped buffer 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 buffers 2114 are designed to steer the device 2100 away from adjacent eye tissue. In some embodiments, the buffers 2114 may deform slightly upon contact with the ciliary structure. This deformation can be temporary, allowing the buffers to return to their original shape, prompting the device 2100 to return to a central position within the eye. Like other embodiments described herein, the device 2100 may include a plurality of fixation arms 2120, including at least one fixation arm biased into a folded configuration. Preferably, once the device 2100 is implanted, the buffer 2114 avoids contact with the ciliary structure. The buffer 2114 can act as a guide during the outward movement of the fixation arms 2120. The buffer 2114 can protrude sufficiently away from the outer periphery 2111 of the lens support structure 2105, such that the buffer 2114 abuts against the ciliary body 15 and / or is within the ciliary sulcus 25 to prevent displacement in the Z-plane, thereby maintaining proper alignment of the central aperture 2115 relative to the visual axis of the eye during fixation.

[0134] This document illustrates various embodiments of a device configured for implantation in the eye and supporting, stabilizing, or otherwise engaging a separate IOL, thereby maintaining the optical alignment of the IOL. The devices described herein can be combined in any reasonable combination of various configurations. For example, although... Figure 1A-1F The devices 2A-2B, 3, and 4A-4B are described in the context of incorporating one or more buffer elements 2114, but the device may additionally or alternatively incorporate one or more fixing arms 2120 and / or post-stabilization structures 2138. Although Figures 5A-5C The devices are described in the context of having a post-stabilized configuration 2138, but they may additionally or alternatively incorporate one or more fixed arms 2120 and / or buffers 2114. Although Figures 6A-6E as well as Figures 8A-8F and Figures 9A-9B The apparatus is described in the context of having a buffer 2114 and a post-stabilization structure 2138, but they may additionally or alternatively incorporate one or more fixed arms 2120. Figure 10A-10D The device shown and Figure 11A-11F The same applies to the devices shown in 12A-12C, 13A-13E, 15, and 17. Any combination of the constructions described herein can be combined with the devices in any of a variety of combinations to achieve a variety of functional purposes.

[0135] Figure 18A A related embodiment of device 2100 is shown, in which a rear platform 2105 and a canopy 2110 form a base with a rectangular shape. The base has a front end 2101 and a gradually decreasing rear end 2106. The rear end 2106 of the base, located between the rear retaining arms 2120a and 2120b, may be narrower than the width of the front end 2101 of the base near the front retaining arm 2120c. The rear end 2106 of the base may be narrower than the width of the front end 2101 of the base by at least approximately 0.2 mm, approximately 0.3 mm, approximately 0.4 mm, approximately 0.5 mm, approximately 1.0 mm, approximately 1.5 mm, or approximately 2.0 mm.

[0136] Figure 18B-18C They are shown respectively Figure 18A The top and perspective views of the device 2100, which incorporates a plurality of fixed arms 2120 (one or more of which can be biased into a folding configuration) and a post-stabilization configuration 2138. Figure 18D It shows Figure 18B-18C The device incorporates a plurality of fixed arms 2120 (one or more of which can be biased into a folded configuration) and a post-stabilization configuration 2138 additionally incorporated with a plurality of buffers 2114.

[0137] Once the fixation arm 2120 is anchored in the eye, it applies forces to the device, which can damage the optics of the IOL positioned relative to the device. For example, depending on the tension on the fixation arm 2120, the rear platform 2105, canopy 2110, sidewall 2112, or other parts of the device 2100, especially those forming the IOL housing, may deform. This deformation can be transmitted to the IOL and negatively affect the optics. The device described herein may incorporate one or more constructions designed to resist deformation caused by forces applied to the device, whether those forces are from the tension of the fixation arm 2120 or from the force applied by the eye to the device 2100.

[0138] As mentioned above, relative to Figure 20A-20D As discussed, the device can incorporate reinforcing materials to improve circumferential strength and resistance to deformation, which may or may not increase the material thickness of the reinforced device region. The material thickness of one or more regions of device 2100 may also be increased to provide improved circumferential strength with or without additional reinforcing materials. Figure 18E-18HAn embodiment of a device 2100 incorporating multiple fixed arms 2120 is shown. The rear platform 2105 and sidewalls 2112 are reinforced by the increased material thickness in these areas of the device. Figure 18F It was cut off along arrow FF. Figure 18E A cross-sectional view of device 2100 is shown, illustrating an increased cross-sectional thickness (e.g., approximately 0.50 mm) of the posterior platform 2105 and an increased thickness (e.g., from approximately 0.35 mm to approximately 0.60 mm, or up to approximately 1.5 mm) of the sidewalls 2112. The increased material thickness provides greater stiffness to the lens support structure, facilitating easier IOL insertion after implantation. The increased material thickness also enhances the circumferential strength of the central aperture 2115 through the posterior platform 2105, limiting the risk of accidental IOL passage through the aperture 2115 during implantation into device 2100.

[0139] The diameter D of the central orifice 2115 can also be reduced. a To improve the circumferential strength of the posterior platform 2105, the diameter of the central aperture 2115 can be less than approximately 5.0 mm, with a minimum of approximately 4.0 mm, and preferably approximately 4.75 mm, to avoid interfering with the optics of the IOL. The aperture size, alone or in combination with the posterior platform thickness and / or sidewall thickness, can resist deformation of the device that may be caused by the tensioned fixation arm. The aperture diameter can also limit the risk of the IOL accidentally passing through the aperture 2115 during implantation, not only because of the size of the aperture 2115, but also because of the increased circumferential strength of the aperture 2115. A smaller aperture diameter can improve circumferential strength compared to a larger aperture diameter. A stiffer IOL shell can limit deformation of the aperture 2115 under tension and / or pressure. Increasing the stiffness of the IOL shell also facilitates easier IOL insertion after intraocular fixation.

[0140] The thicker sidewalls 2112 of the device may reduce the space available for IOL manipulation within it. To provide more space for IOL manipulation within the recess 2104, the external length along the long axis of the device can be increased to accommodate the thicker sidewalls 2112, and to provide an internal length along the same axis for IOL insertion and manipulation within the recess (see [reference]). Figure 18G The platform 2105, along the long axis of the device, can have an external length L of approximately 9.2 mm. e and an internal length L of approximately 8.5 mm along the same axis i This results in a sidewall thickness of approximately 0.7 mm. To provide additional reinforcement to device 2100, the sidewall cross-sectional thickness can be increased to approximately 1.2 mm. The platform can be increased to approximately 11 mm along its long axis, such that the internal length L along the same axis... iIt is approximately 9.8 mm. The increased cavity length provides more space within which the IOL can be manipulated, which, combined with the increased sidewall thickness, results in an increased external device length L. e Longer devices can be secured via the ciliary body plana and thus behind the ciliary body apex, thereby ensuring space for implantation of a larger IOL shell even if the device is too wide in the plane of the ciliary body apex (see [link to documentation]). Figure 18H The minor axis width may also be affected by the thicker sidewalls 2112 (see...). Figure 18F The rear platform 2105 may have an external width W of approximately 6.60 mm along the short axis of the device. e and an internal width of approximately 6.60 mm along the same axis W i This results in the sidewall 2112 having a thickness of approximately 0.7 mm. As mentioned above, the cross-sectional thickness of the sidewall 2112 can be increased to 1.2 mm. The platform 2105 can be increased to approximately 7.4 mm along its minor axis, resulting in an internal width W along the same axis. i It is approximately 6.2 millimeters.

[0141] The device described herein is used for intraocular IOL support. The device described herein may be combined with one or more structures configured to engage at least a portion of the capsular bag for centering or fixation in the eye. The device described herein may be combined with one or more structures configured to fix the device in the eye and center it even in the absence of capsular bag support, such as due to iatrogenic damage to the lens support during surgery or late complications of a previous surgery. Regardless of the presence or absence of capsular bag support, observability of the device during implantation is important. In some embodiments, a bent or biased fixation arm 2120 allows direct observation of the device through the pupil, making the arm 2120 easier to grip, which is particularly useful during the outward movement and fixation of the device within the eye. Even without the fixation arm 2120, the device described herein can be directly observed through the pupil. In some embodiments, the anterior geometry of the device 2100 is modified to improve anterior observability through the pupil. For example, the size and shape of the anterior canopy 2110 can be designed to have at least one portion that protrudes more inward or towards the center than other parts (e.g., towards the central axis through the central opening 2115), so that the centrally protruding portion of the canopy 2110 is visible anteriorly through the dilated pupil and is not substantially obstructed by the iris. The geometry of the canopy 2110 is visible relative to the implanted IOL without affecting the optics of the IOL. This increases the likelihood that the IOL is correctly secured within the recess 2104 of the device 2100. Postoperative lens dislocation can occur when the IOL loop is left in a position anterior to the device 2100. Uncertainty regarding the lens position increases surgical time and the likelihood of tissue damage when the surgeon manipulates the device and / or tissue to confirm the lens's position relative to the device. The ability to directly observe the device 2100 through the pupil reduces this uncertainty, especially when the pupil diameter is reduced during surgery.

[0142] Figure 18E and Figure 18I-18J An example of a front awning 2110 with a centrally projecting observation structure 2117 is shown. The observation structure 2117 can project centrally to allow direct observation of the device 2100 while avoiding interference with the optics of the IOL after implantation. The observation structure 2117 can project sufficiently toward the central axis of the central aperture 2115, for example, at least about 2.5 mm to about 3 mm away from the central axis, so that the structure 2117 is visible through the pupil during implantation. The centrally projecting observation structure 2117 can narrow the internal dimensions of the front opening 2127, for example, the distance D1 along the long axis of the front opening 2127 (see...). Figure 18H and 18GMeanwhile, the overall size of the front opening 2127 remains relatively large to allow access to the internal recess 2104. The distance D1 along the long axis of the device between the central edges of the front opening 2127 formed by the opposing canopy observation structure 2117 can be at least approximately 7.0 mm to approximately 5.0 mm, preferably approximately 6.0 mm. This distance D1 is chosen to be greater than the diameter D of the central aperture 2115. a For example, the diameter D of the central orifice 2115 a It can be approximately 4.75 mm, while observing the distance D between structures 2117 l The diameter can be approximately 5.00 mm, approximately 5.25 mm, approximately 5.50 mm, approximately 5.75 mm, approximately 6.00 mm, up to approximately 7.00 mm. Therefore, even when the awning 2110 incorporates one or more observation features 2117, the size of the front opening 2127 defined by the feature 2117 can be larger than the diameter D of the central aperture 2115. a .

[0143] Figure 18E The configuration 2117 shown protrudes centrally from the front fixing arm 2120c, such that the coverage provided by the canopy 2110 near this arm is greater than the coverage provided by the canopy 2110 near the corner where the short side 2107 and long side 2108 of the device 2100 intersect. Therefore, this pair of configurations 2117 can be located on the short side 2107 of the device and protrude along the long axis. The observation configuration 2117 can also be located on the long side 2108 of the device and protrude along the short axis (i.e., rotated 90 degrees relative to the orientation shown in the figure). The observation configurations 2117 can be located anywhere around the periphery of the front region of the device, as long as they extend sufficiently inward to be visible from behind the iris edge when the device is positioned in the eye. The discrete observation configurations 2117 avoid the front opening 2127 narrowing around its entire circumference, providing frontal viewing capability without significantly impairing the user's ability to position the IOL within the recess 2104 in front of the platform 2105 through the front opening 2127.

[0144] One or more components of the device described herein may also incorporate visual markings to guide the positioning of the IOL 110 relative to the device 2100. For example, one or more markings may be located on the posterior platform 2105, the anterior surface of the device, the canopy 2110, the sidewall 2112, or another portion of the device 2100. These markings can assist in the alignment and implantation of the toroidal lens relative to the device 2100. These markings can allow for intraoperative assessment of the position of the device and / or the IOL 110 relative to the device 2100. One or more components of the device 2100 may be formed of a material that is not clearly visible during assessment using imaging techniques such as UBM, such as silicone. One or more visual markings can assist in the assessment of the device's position because these markings can be formed of a visible material. These markings can help ensure the correct plane of the device is achieved prior to implantation of the IOL 110. These markings can help inform the operator of the relative position of the IOL 110 for correct orientation. In some implementations, one or more markings may be used to align the tortuous surface IOL 110 relative to the device 2100.

[0145] The device described herein can be inserted via a corneal or scleral incision using forceps or other common ophthalmic instruments. Alternatively, an injector system similar to an intraocular lens injector can be used to insert the device. This injector allows the device to unfold in a manner that presents the various parts of the device sequentially to the surgeon. Alternatively, the injector can deliver the entire device into the anterior or posterior chamber in a form that limits the risk of surgical error. For example, the injector can ensure that the device is inserted "face up." Furthermore, the injector can limit the risk of injury to the iris, endothelium, capsule, or suspensory ligaments during implantation. The IOL 110 can be positioned within the device 2100 before or after implantation in the eye. Similarly, the IOL 110 can be removed from and replaced from the device 2100 postoperatively.

[0146] The IOL 110 can be positioned relative to device 2100, ensuring it is securely fixed for correct orientation and optical performance. Although the IOL 110 is securely fixed relative to device 2100, it is still possible to remove the IOL 110 from device 2100. This allows for the removal and replacement of the IOL 110 with another after implantation of device 2100. Some patients may acquire an IOL 110 during implantation but later discover that it has an incorrect refractive power that prevents them from achieving normal vision. Other patients may acquire a multifocal lens IOL 110 but later determine that the visual quality is unsatisfactory. Furthermore, a patient's refractive error may continue to drift over time. In any of these cases, the patient may require a new IOL. Under standard circumstances, IOL replacement is nearly impossible because many IOLs are implanted within a capsular bag, which undergoes capsular fibrosis around the lens. Device 2100 allows for easy and relatively uncomplicated replacement of an already implanted IOL 110.

[0147] Suitable materials or combinations of materials for the fabrication of various components of the devices disclosed herein are provided herein. It should be understood that other suitable materials may also be considered. The device can be constructed from any implantable material capable of providing the required functionality for sidewalls, posterior platforms, cushioning, or stabilization construction and / or tethering. Materials that can be used in the device may be, but are not limited to, silicone elastomers, fluorosilicone elastomers, polyurethanes, hydrophilic or hydrophobic acrylic resins, polyolefins, nylon, PVDF, PMMA, polyimide, nickel-titanium alloys, titanium, stainless steel, or other implantable materials. The device can be made from a combination of materials that are geometrically matched together, chemically bonded or welded to each other, overmolded, encapsulated, or otherwise combined for combining multiple materials. A given device element can be made from a variety of materials. One or more components may be constructed from inelastic or semi-rigid materials commonly used in ophthalmic applications, such as polypropylene, nylon, PVDF, polyimide, PMMA, polyurethane, hydrophilic or hydrophobic acrylic resins, or high-hardness silicone resins. One or more components may be incorporated with or formed from an elastic material that facilitates manipulation during implantation, such as acrylic resins, polyurethanes, silicone elastomers, or copolymers thereof. In other embodiments, 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 resins, or high-hardness silicone resins embedded or coated with a soft elastic material (e.g., acrylic resins, polyurethanes, silicone elastomers, or copolymers thereof). Other materials may include PEG, HEMA, NVP, collagen or other hydrophilic biocompatible coatings, nylon, polypropylene, Gore-Tex, PVDF, Teflon, nickel-titanium alloys, stainless steel, silver, and gold for mechanical reinforcement and / or improved observability. One or more components of the device may be formed as independent parts coupled to each other by any of a variety of suitable methods. Alternatively, one or more components of the device may be formed as a single piece or integral element, for example by injection or compression molding, to provide a relatively seamless and continuous surface. Any of a variety of material combinations is considered herein.

[0148] Various embodiments are described with reference to the accompanying drawings. However, some embodiments may be implemented without one or more of these specific details, or in combination with other known methods and configurations. Numerous specific details, such as specific configurations, dimensions, and processes, are set forth in this specification to provide a thorough understanding of the embodiments. In other instances, well-known processes and manufacturing techniques are not specifically described to avoid unnecessarily obscuring the description. In this specification, references to “an embodiment,” “an example,” “an implementation,” “implementation,” etc., mean that at least one embodiment or implementation includes the specific feature, structure, configuration, or characteristic described. Therefore, the phrases “an embodiment,” “an example,” “an implementation,” “implementation,” etc., appearing in various places throughout this specification do not necessarily refer to the same embodiment or implementation. Furthermore, specific features, structures, configurations, or characteristics may be combined in a suitable manner in one or more embodiments.

[0149] The devices and systems described herein can combine any of a variety of features. An element or feature of one embodiment of the devices and systems described herein can be substituted for or combined with an element or feature of another embodiment of the devices and systems described herein. For the sake of brevity, although various combinations are considered herein, explicit descriptions of each of these combinations may be omitted. Furthermore, the devices and systems described herein can be positioned in the eye, but not necessarily implanted in the specific manner shown in the figures or as described herein. Various devices can be implanted, positioned, and adjusted using various different methods and using various different devices and systems. Various devices can be adjusted before, during, and after implantation. Although some representative descriptions of how to implant and position various devices are provided herein, for the sake of brevity, explicit descriptions of each method for each implant or system may be omitted.

[0150] In this specification, the use of relative terms may indicate relative position, direction, or orientation, and is not restrictive. For example, "far side" may indicate a first direction away from a reference point. Similarly, "proximal side" 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 "rear," as well as "front," "rear," "tail," and "head," is used to establish a relative frame of reference and is not intended to limit the use or orientation of any device described herein in various embodiments.

[0151] The term "approximately" refers to a range of values ​​that includes the specified value and that would be reasonably similar to the specified value by one of ordinary skill in the art. In embodiments, "approximately" means using a measurement within a standard deviation generally acceptable in the art. In embodiments, "approximately" means a range extended to ±10% of the specified value. In embodiments, "approximately" includes the specified value.

[0152] While this specification contains numerous specific implementation details, these details should not be construed as limiting the scope of the claims or potentially claimed protections, but rather as descriptions of specific features of particular embodiments. Certain features described in the context of various embodiments in this specification may also be implemented in combination in a single embodiment. Conversely, various features described in the context of a single embodiment may also be implemented individually or in any suitable sub-combination in multiple embodiments. Furthermore, while features may be described above as functioning in certain combinations, and even initially claimed in this way, in some cases one or more features in a claimed combination may be removed from that combination, and the claimed combination may involve sub-combinations or variations thereof. Similarly, while certain operations are described in a particular order in the drawings, this should not be construed as requiring these operations to be performed in the specific order shown or sequentially, or requiring the performance of all shown operations to obtain the desired result. Only a few examples and embodiments are disclosed herein. Based on the disclosure, various changes, modifications, and enhancements can be made to the illustrated examples and embodiments, as well as other embodiments.

[0153] In the foregoing description and in the technical solutions, phrases such as "at least one" or "one or more" may appear before a combined list of elements or features. The term "and / or" may also appear in a list of two or more elements or features. Unless implied or expressly defined in its context, such phrases are intended to mean any element or feature listed separately, or any listed element or feature combined with any other listed element or feature. 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 "only A," "only B," or both A and B, respectively. A similar interpretation applies to 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 "only A," "only B," "only C," "both A and B," "both A and C," "both B and C," or "both A, B, and C," respectively.

[0154] The term “based on” as used above and in the technical solution is intended to mean “at least partially based on”, thus allowing for features or elements not listed.

[0155] Example Example 1: An implantable device for supporting an intraocular lens in an eye having an anterior segment with a capsular bag, the device comprising: a posterior platform including an inner wall that at least partially defines a central aperture, wherein light passes through the central aperture toward the retina when the device is implanted in the posterior chamber of the eye; and at least one awning positioned on an anterior surface of the posterior platform to form at least one recess between the awning and the posterior platform, wherein the device is configured to be deployed in the posterior chamber without requiring transscleral fixation of the device.

[0156] Example 2: According to the device of Example 1, the at least one canopy is adapted to cooperate with the periphery of the intraocular lens or with one or more haptics of the intraocular lens.

[0157] Example 3: The device according to Example 1 or 2, wherein at least a portion of the artificial lens is positioned within the at least one recess.

[0158] Example 4: The device according to any one of Examples 1-3, wherein the outer surface of the at least one canopy has a smooth geometry to protect the iris from damage to the intraocular lens when the device is implanted in the posterior chamber.

[0159] Example 5: The device according to any one of Examples 1-3, wherein, when positioning the intraocular lens on the device, the inner surface of the at least one canopy provides a counter-pressure to the haptic of the intraocular lens.

[0160] Example 6: A system comprising the apparatus according to any one of Examples 1-5, further comprising an artificial lens.

[0161] Example 7: The system according to Example 6, wherein the intraocular lens is a single-piece intraocular lens or a multi-piece intraocular lens.

[0162] Example 8: The system according to Example 6 or 7, wherein the single-piece intraocular lens is selected from the group consisting of monofocal, toric, multifocal, extended depth-of-focus, and adjustable intraocular lenses.

[0163] Example 9: A method of implanting a device according to Examples 1-8, comprising: inserting the device into the posterior chamber of the eye; and positioning a single-piece intraocular lens relative to the posterior platform such that at least a portion of the intraocular lens is positioned under the at least one canopy.

[0164] Example 10: According to the method of Example 9, the haptic of the intraocular lens is positioned under the at least one canopy.

[0165] Example 11: The method of implanting a device according to Example 9 or 10, wherein inserting the device into the posterior chamber of the eye includes inserting the device but not fixing the device through the sclera.

[0166] Example 12: The device according to any one of Examples 1-11, wherein the rear platform is generally annular.

[0167] Example 13: The apparatus according to any one of Examples 1-12 further includes one or more stabilization features.

[0168] Example 14: The device according to any one of Examples 1-13, wherein the one or more stabilizing structures include a plurality of buffers that project outward from the rear platform to provide non-penetrating contact with the ciliary body tissue in the eye to achieve centralization.

[0169] Example 15: The device according to any one of Examples 1-14, wherein the rear platform includes a substantially non-circular outer periphery and a substantially circular inner periphery.

[0170] Example 16: The device according to any one of Examples 1-15, wherein the outer perimeter is substantially rectangular and has a pair of long sides and a pair of short sides.

[0171] Example 17: The apparatus according to any one of Examples 1-16, wherein the plurality of buffers comprises four buffers, and wherein each of the four buffers extends radially outward from the location where the long side intersects the short side.

[0172] Example 18: The apparatus according to any one of Examples 1-17, wherein the one or more stabilization structures include a post-stabilization structure configured to engage with at least a portion of the sac.

[0173] Example 19: The apparatus according to any one of Examples 1-18, wherein the post-stabilization configuration includes a first portion projecting rearward from the rearward surface of the rear platform and a second portion projecting laterally outward from the first portion.

[0174] Example 20: The device according to any one of Examples 1-13, wherein the one or more stabilizing structures include a plurality of buffers projecting outward from the posterior platform to provide non-penetrating contact with the ciliary muscle tissue in the eye to achieve centralization, and includes a posterior stabilizing structure configured to engage at least a portion of the capsular pouch.

[0175] Example 21: The device according to any one of Examples 1-20, wherein the anterior segment of the sac provides support for the device along the Z-axis of the eye.

[0176] Example 22: A method for supporting an artificial lens (IOL) in an eye, the method comprising: preparing a lens support device for insertion into the eye, the lens support device comprising: a posterior platform having an anterior surface and a posterior surface; a central aperture extending through the posterior platform, wherein, when the lens support device is implanted in the eye, light passes through the central aperture toward the retina; at least one canopy protruding over at least a portion of the anterior surface of the posterior platform, the at least one canopy having an inner surface and an outer surface, the canopy forming at least one recess between the inner surface of the canopy and the anterior surface of the posterior platform; and a buffer member projecting radially outward from the device. The buffer has a radially outermost portion for seamless positioning within the posterior chamber to position the lens support device in the eye; positioning the lens support device in the eye behind the iris such that the posterior surface of the posterior platform is positioned anterior to the anterior portion of the eye's capsule, and preventing any part of the device from contacting the sclera of the eye; positioning the radially outermost portion of the buffer near the ciliary sulcus to position the central aperture posterior to the pupil of the eye; positioning the optic of the IOL above the central aperture and anterior to at least a portion of the anterior surface of the posterior platform; and positioning at least a portion of the IOL's haptic within the at least one recess to secure the IOL to the lens support device.

[0177] Example 23: A method for implanting an artificial lens (IOL) in an eye, the method comprising: creating an opening in the anterior wall of the capsular bag of the eye; preparing a lens support device for insertion into the eye, the lens support device comprising: a body portion including a central opening and a lens support structure, the lens support structure including a substantially flat lens support surface at least partially surrounding the periphery of the central opening, and at least one recess located anterior to the lens support surface, wherein, when the device is implanted in the eye, light passes through the central opening toward the retina; a plurality of radially extending structures coupled to the body portion, each of the plurality of radially extending structures including a radially outermost portion for seamlessly positioning the device within the posterior chamber of the eye; and extending posteriorly from the posterior surface of the lens support structure. Multiple stabilizing structures; inserting the lens support device into the eye and behind the iris of the eye such that no part of the device contacts the sclera of the eye after insertion; positioning the radially outermost portion of each of the multiple structures near the posterior atrial sulcus to stably position the central opening behind the pupil of the eye; inserting each of the multiple stabilizing structures through the opening in the anterior wall of the capsular bag to help anchor the device relative to the capsular bag; inserting an IOL into the eye; positioning the optics of the IOL above the central opening and before at least a portion of the substantially flat lens support surface; and positioning at least a portion of the haptic of the IOL within the at least one recess of the lens support structure to secure the IOL to the lens support device.

[0178] Example 24: An implantable device for supporting an intraocular lens in an eye having an anterior segment with a capsular bag, the device comprising: a posterior platform including an inner wall that at least partially defines a central aperture, wherein when the device is implanted into the posterior chamber of the eye, light passes through a central optic and a central aperture toward the retina; and at least one awning positioned over an anterior surface of the posterior platform to form at least one recess between the awning and the posterior platform, wherein the device is configured to not require scleral fixation during deployment.

[0179] Example 25: The apparatus according to Example 24, wherein the rear platform further includes one or more cuts around the central opening.

[0180] Example 26: The device according to Example 24 or 25, wherein the size and shape of the rear platform are such that it supports the central optic of the intraocular lens on the anterior surface of the rear platform, and the size and shape of the one or more incisions are such that they receive at least a portion of the haptic of the intraocular lens when the intraocular lens is implanted in the at least one recess of the device.

[0181] Example 27: The device according to any one of Examples 24-26 further includes one or more stabilizing structures configured to engage with at least a portion of the pouch.

[0182] Example 28: The apparatus according to any one of Examples 24-27, wherein one or more stabilizing structures extend after the at least one recess.

[0183] Example 29: The apparatus according to any one of Examples 24-28, wherein one or more stabilizing structures extend before the at least one recess.

[0184] Example 30: A method for implanting an artificial lens (IOL) in an eye, the method comprising: creating an opening in the anterior wall of the capsular bag of the eye; preparing a lens support device for insertion into the eye, the lens support device comprising: a body portion including a central opening, wherein, when the lens support device is implanted in the eye, light passes through the central opening toward the retina, the body portion further comprising a lens support surface at least partially surrounding the periphery of the central opening, and at least one recess located anterior to the lens support surface; and at least one stabilizing structure extending posteriorly from the posterior surface of the lens support structure; and inserting the lens... The lens support device is inserted into the eye and the iris of the eye such that no part of the device contacts the sclera of the eye after insertion; the at least one stabilizing structure is inserted through the opening in the anterior wall of the capsule to anchor the lens support device relative to the capsule and to position the central opening behind the pupil of the eye; an IOL is inserted into the eye; the optics of the IOL are positioned above the central opening and anterior to at least a portion of the lens support surface; and at least a portion of the loop of the IOL is positioned within the at least one recess to secure the IOL to the lens support device.

[0185] Example 31: According to the method of Example 30, the lens support device further includes a plurality of radially extending structures coupled to the body portion, each of the plurality of radially extending structures including a radially outermost portion for seamlessly positioning the device within the eye, and the method further includes positioning the radially outermost portion of each of the plurality of radially extending structures near the ciliary sulcus of the eye to prevent rotation about the visual axis and to help center the device relative to the eye.

Claims

1. An implantable device (2100) for supporting an artificial lens (AIOL) in the eye, the device comprising: The rear platform (2105) includes a forward-facing surface, an inner wall (2109), and an outer periphery, the inner wall at least partially defining a central opening (2115), and the outer periphery including a pair of long sides (2108) along the longer axis of the device and a pair of short sides (2107) along the shorter axis of the device. as well as At least one canopy (2110) is located above the forward-facing surface of the rear platform, thereby forming at least one recess (2104) in front of the rear platform, the at least one recess being sized to receive at least a portion of the intraocular lens to form an assembly system, the at least one canopy including an edge that at least partially defines an anterior opening (2127), wherein the at least one canopy includes a first region that projects inward to reduce the distance across the anterior opening to form an observation configuration (2117), and wherein the at least one canopy includes a second region (2130) positioned to cover the junction (115) between the optics (112) and the haptic (114) of the intraocular lens of the assembly system. The assembly system is sized to be deployed behind the iris within the ciliary sulcus (25) of the eye, such that no part of the device comes into contact with the sclera (20) of the eye after implantation, and when the assembly system is deployed in the eye, light passes through the artificial lens and the central aperture of the posterior platform toward the retina of the eye.

2. The apparatus according to claim 1, wherein, When in use, the observation structure is directly seen through the pupil of the eye.

3. The apparatus according to claim 1, wherein, The reduced distance across the front opening is the distance between the most central edges of the front opening along the longer axis of the device.

4. The apparatus according to claim 3, wherein, The distance between the most central edges of the front opening along the longer axis of the device is less than 7.0 mm to 5.0 mm.

5. The apparatus according to claim 3, wherein, The distance between the most central edges of the at least one canopy along the longer axis of the device is greater than the diameter of the central opening.

6. The apparatus according to claim 1, wherein, The observation structure is located 2.5 mm to 3 mm from the central axis of the device.

7. The apparatus according to claim 1, wherein, The outer surface of at least one canopy has a smooth geometry to protect the iris from damage to the artificial lens when the assembly system is implanted.

8. The apparatus according to claim 1, wherein, When the intraocular lens is positioned within the at least one recess, the inner surface of the at least one canopy provides counter-pressure to the haptic region of the intraocular lens.

9. The device of claim 1, further comprising a plurality of radially extending structures (2114) coupled to the device for stabilizing the device within the eye, preventing the device from rotating within the eye, and facilitating the centering of the device relative to the optical axis of the eye, wherein each of the plurality of radially extending structures includes a radially outermost portion for seamlessly positioning the device within the eye, providing non-penetrating contact with the ciliary sulcus of the eye when the assembly system is implanted in the eye.

10. The apparatus according to claim 9, wherein, Each of the plurality of radially extending structures is coupled to the device at an angle to the rearward surface of the rear platform.

11. The apparatus according to claim 9, wherein, The outermost radial portion of each of the plurality of radially extending structures is positioned further forward than the first and second ends of each of the plurality of radially extending structures.

12. The device according to claim 1, wherein the intraocular lens is a single-piece intraocular lens or a multi-piece intraocular lens, wherein the single-piece intraocular lens is selected from the group consisting of monofocal, toric, multifocal, extended depth-of-focus, and adjustable intraocular lenses.

13. The apparatus according to claim 1, wherein, The rear platform and the at least one canopy form a base having a front end (2101) and a rear end (2106), wherein the rear end is narrower than the front end.

14. The apparatus according to claim 1, wherein, The inner wall is closed and substantially circular in shape, while the front opening is free-form.

15. The apparatus according to claim 14, wherein, The diameter of the closed, substantially circular shape is smaller than the diameter of the optical portion of the intraocular lens and smaller than the distance across the anterior opening.

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