Device and method for supporting and disposing an intraocular lens in the eye

Abstract

Implantable devices, related tools, systems and methods are provided for supporting an intraocular lens within an eye, including a lens support structure having a central opening and one or more fixation arms coupled to the lens support structure and configured to position and stabilize the device within the eye.

Description

Technical Field

[0001] (Cross - Reference to Related Applications) This application is a continuation of co - pending U.S. Patent Application No. 16 / 988,519, filed on August 7, 2020, and claims the benefit of priority under 35 U.S.C. § 119(e) to U.S. Provisional Patent Application No. 63 / 017,423, filed on April 29, 2020, and U.S. Provisional Patent Application No. 63 / 053,450, filed on July 17, 2020. The disclosures of these applications are hereby incorporated by reference in their entirety.

[0002] This disclosure generally relates to the field of ophthalmology, and more particularly, to ophthalmic devices for supporting and positioning an intraocular lens within the eye.

Background Art

[0003] The implantation of an intraocular lens (IOL) requires support within the eye to hold the intraocular lens in the correct position. Typically, this is achieved by the lens capsule suspended by zonular fibers (structures like thin threads). However, these support structures can be impaired by either endogenous factors such as pseudoexfoliation of the lens, Marfan syndrome, Weill - Marchesani syndrome, or exogenous factors such as trauma. Additionally, lens support can be iatrogenically impaired during surgery (anterior segment or posterior segment surgery) or as a late complication of a previous surgery, for example, by capsular phimosis.

Summary of the Invention

Problems to be Solved by the Invention

[0004] The management of secondary intraocular lens implantation in the absence of adequate support of the lens capsule or zonules continues to evolve. Currently, the only solution approved by the FDA is the implantation of an anterior chamber intraocular lens (ACIOL). An ACIOL is a large lens positioned in front of the iris, but over time, it can cause uveitis-glaucoma-hyphema syndrome (UGH), endothelial cell loss, corneal decompensation, etc., and is contraindicated in many patients. Modified capsular tension rings (Cionni or Ahmed) can be used off-label to provide scleral support for sutures to a partially weakened lens capsule. However, when the capsule and zonules are substantially compromised, it is necessary to fix the lens without using these native support structures. There are also other off-label techniques such as iris-sutured intraocular lenses, but they are technically difficult and can cause glaucoma due to iris pigment loss. Finally, scleral-sutured intraocular lenses with islets are technically complex, have a risk of rotation, the durability of the sutures is unknown, and there are reported cases of breakage and lens subluxation (lens subluxation). Furthermore, all of these techniques force the surgeon to use a different type of lens for the patient instead of a preferred lens. Finally, despite inadequate lens calculations in the initial vitrectomy or cataract surgery, there is a patient preference not to have additional posterior segment surgery, and often an ideal lens is not implanted.

Means for Solving the Problems

[0005] In one aspect, a transplantable device for supporting an intraocular lens within the eye, comprising a support structure having an outer peripheral surface, a front facing surface, a rear facing surface, and one central opening extending through the entire thickness of the support structure between the front facing surface and the rear facing surface, the one central opening having a continuous inner circumference, is described. The device includes a plurality of fixation arms coupled to the support structure and configured to be under tension to position and stabilize the device within the eye. Each of the plurality of fixation arms has a terminus that is coupled to a transscleral anchor for sutureless scleral fixation.

[0006] The scleral anchor is configured to be externalized non-invasively. The scleral anchor can be positioned outside the sclera and inside the conjunctiva. At least one of the plurality of fixation arms can be substantially non-planar. The plurality of fixation arms can include three fixation arms extending outward from the outer peripheral surface of the support structure. At least the first fixation arm of the three fixation arms can be biased toward the center of the device. At least the first fixation arm and the second fixation arm of the three fixation arms can each be biased toward the center of the device. The third fixation arm of the three fixation arms can increase the cross-sectional area compared to the cross-sectional areas of the first fixation arm and the second fixation arm. By increasing the cross-sectional area of the third fixation arm, the rigidity can be increased compared to the rigidity of either the first fixation arm or the second fixation arm. The three fixation arms can be evenly arranged around the outer peripheral surface of the support structure.

[0007] The front facing surface can form a stable platform on which the intraocular lens is disposed during use. The continuous inner peripheral surface can be uniform and substantially circular in shape, and the outer peripheral surface can be substantially non-circular in shape. When in use, the support structure can provide centering of the device without 360-degree contact with the ciliary body along the substantially non-circular outer peripheral surface. When in use, the substantially non-circular outer peripheral surface of the support structure can avoid contact with the ciliary body or can contact the ciliary body along less than 120 degrees. When in use, the substantially non-circular outer peripheral surface of the support structure can contact the ciliary body processes at three different points. The outer peripheral surface of the support structure can include a plurality of lobes protruding outward from a plurality of substantially flat or concave sides. The plurality of lobes can include three convex lobes that give the support structure a substantially rounded triangular shape. The three convex lobes can provide an anti-rotation function in the Z-plane. When in use, the three convex lobes can provide non-penetrating contact with the ciliary body.

[0008] The support structure can include one or more slits formed in an inner wall that defines a central opening. The support structure can have a thickness that tapers toward the central opening from a front facing surface to a rear facing surface. At least one of the plurality of fixation arms can include a plurality of anchors along its length that include a scleral anchor at its terminus. When used, the scleral anchor can be configured to be disposed outside of the sclera. The scleral anchor can have a shape configured to pass through the sclera in a first direction during insertion and configured to resist passing through the sclera in a second, opposite direction. When in a stationary state, at least one of the plurality of fixation arms can incorporate a bend that forms a curved fixation arm between a starting point with the support structure and a terminus coupled to the scleral anchor. The bend can be between 90 degrees and 270 degrees in a radial and centripetal direction from the starting point. The bend can be 180 degrees from the starting point with the support structure. During installation, the terminus of the curved fixation arm can be in a plane different from the plane of the support structure and the scleral anchor can be positioned over at least a portion of the support structure. The bent fixation arm can incorporate an elastic material or a deformable hinge to facilitate straightening the bent fixation arm such that the terminus approaches the plane of the support structure. Two of the fixation arms can be flexible and have an inward biasing and a third fixation arm can be less flexible than the two fixation arms. Each scleral anchor of the plurality of fixation arms is configured to be positioned external to the sclera. The scleral anchor can include a central portion and one or more peripheral grippable portions. The central portion can be positioned over the wound where the anchor is externalized during implantation. The central portion can have an increased thickness, height, and / or width compared to the peripheral grippable portions. One of the plurality of fixation arms is mechanically reinforced. The mechanical reinforcement can bias the device forward during implantation.

[0009] In related aspects, a method of implanting a capsulorhexis device with artificial zonular fixation that provides a stable platform for placing an intraocular lens in an artificially constructed groove is provided.

[0010] In related aspects, an implantable device for supporting an intraocular lens in the eye having a support structure substantially in a first plane is provided. The support structure has an outer peripheral surface, a front facing surface, a rear facing surface, and one central opening extending through the entire thickness of the support structure between the front facing surface and the rear facing surface. The one central opening has a continuous inner perimeter. The device has three fixation arms coupled to the support structure and is configured to place and stabilize the device in the eye. Each of the three fixation arms has a terminus coupled to a transscleral anchor for fixing the sclera without sutures. In a resting state, at least a first fixation arm of the three fixation arms has a bend between its origin and terminus with the support structure, forming a first bent arm. The terminus of the first bent arm is in a second plane different from the first plane.

[0011] The transscleral anchor of the first bent arm can be positioned over at least a portion of the support structure. The transscleral anchor of the bent arm can be positioned over at least a portion of the central opening. At least a second fixation arm of the three fixation arms incorporates a bend between its origin and terminus with the support structure, forming a second bent arm. The terminus of the second bent arm can be in a second plane different from the first plane. The transscleral anchor of the second bent arm can be positioned over at least a portion of the support structure. The transscleral anchor of the second bent arm can be positioned over at least a portion of the central opening. The third fixation arm of the three fixation arms is straight from its origin to its terminus with the support structure, forming a straight-shaped fixation arm. The straight-shaped fixation arm can be less flexible than the first bent arm and the second bent arm. The first bent arm and the second bent arm can be biased toward the central axis of the device.

[0012] In an interrelated aspect, a transplantable device for supporting an intraocular lens in the eye is provided, having a support structure substantially present in a first plane. The support structure includes an outer peripheral surface, a front facing surface, a rear facing surface, and one central opening extending through the entire thickness of the support structure between the front facing surface and the rear facing surface. The one central opening has an inner peripheral surface having a circumference. The device includes three fixation arms coupled to the support structure and configured to be under tension to place and stabilize the device in the eye. Each of the three fixation arms has a terminus coupled to a trans-scleral anchor for suturingless fixation of the sclera. The inner peripheral surface is uniform and substantially circular in shape, and the outer peripheral surface is substantially non-circular in shape.

[0013] The non-circular shape of the outer peripheral surface can include a plurality of lobes protruding outwardly from a plurality of sides. The plurality of sides can be substantially flat or concave. Each of the three fixation arms can extend outwardly from one of each of the plurality of sides. In the support structure, the width between the outer peripheral surface and the inner peripheral surface can vary circumferentially. Each of the three fixation arms can be longer than the distance by which the plurality of lobes protrude outwardly. The front facing surface and the rear facing surface of the support structure can taper towards the central axis of the device. The inner peripheral surface and the outer peripheral surface can be convex such that the inner peripheral surface protrudes towards the central axis of the device and the outer peripheral surface protrudes away from the central axis of the device. The thickness of the support structure from the front facing surface to the rear facing surface can be from about 0.15 mm to about 1.5 mm. The support structure can be substantially flat. The support structure can incorporate a recess in the front facing surface. The support structure can incorporate one or more posts protruding upwardly from the front facing surface.

[0014] In related aspects, a device for implantation into the posterior chamber of an eye lacking an intact lens capsule is provided. The device includes a support structure having a central opening. The support structure is configured to provide support for an intraocular lens. After implantation into the eye, the device and the intraocular lens are configured to allow light to pass through both the central opening and the intraocular lens. The device includes at least three fixation arms extending substantially orthogonally from the support structure. Prior to implantation, one of the at least three fixation arms extends from the support structure in a deployed configuration, and at least two of the at least three fixation arms extend from the support structure in a folded configuration. One of the at least three fixation arms is biased toward a deployed configuration, and at least two of the at least three fixation arms are biased toward a folded configuration prior to implantation. Upon implantation, each of at least two of the at least three fixation arms is deployed. Each of the at least three fixation arms includes atraumatic distal anchor portions for sutureless transscleral fixation of the device within the posterior chamber.

[0015] In related aspects, a device for implantation into the posterior chamber of an eye lacking an intact lens capsule is provided, the device including a support structure having a central opening extending through the entire thickness of the support structure. The device includes a plurality of fixation arms, each of the plurality of fixation arms having a starting portion at the support structure and a terminal portion coupled to an atraumatic anchor for sutureless transscleral fixation. Prior to transscleral fixation of the anchor, the plurality of fixation arms are curved between their starting and terminal portions and can include curved fixation arms through which at least a portion of the curved fixation arms can be visualized through the pupil of the eye.

[0016] After the anchor is fixed scleral-ly, each of the plurality of fixation arms can apply tension between a starting portion and an ending portion to align the support structure with respect to the Z-plane of the eye. The support structure is configured to provide support for the intraocular lens, and the central opening is configured to allow light to pass through both the central opening and the intraocular lens supported by the support structure. The curved fixation arm can be curved forward, and its atraumatic anchor can be positioned on at least a portion of the support structure. The curved fixation arm can be curved backward, and its atraumatic anchor can be positioned under at least a portion of the support structure.

[0017] In a related aspect, a method of implanting a device into the posterior chamber of an eye lacking an intact lens capsule is provided. The method includes inserting the device into the posterior chamber. The device includes a lens support structure having a central opening and at least three fixation arms. Each of the at least three fixation arms has a starting portion coupled to the lens support structure and a terminal portion with an anchor. Prior to insertion into the posterior chamber, at least one of the at least three fixation arms is biased toward a straight configuration and at least a second of the at least three fixation arms is biased toward a folded configuration. The folded configuration includes a starting portion extending away from the lens support structure, a central portion with a bend, crease or curve, and an anchor of the terminal portion positioned over or under at least one of a portion of the lens support structure and a portion of the central opening. The method includes gripping an anchor of at least one of the at least three fixation arms and externalizing the anchor through and over a first portion of the sclera. The method includes gripping an anchor of a second fixation arm, deploying the folded configuration of the second fixation arm, and externalizing the anchor of the second fixation arm through and over a second portion of the sclera. The method includes gripping an anchor of a third fixation arm of the at least three fixation arms, applying tension to the third fixation arm, and externalizing the anchor of the third fixation arm through and over a third portion of the sclera to position and stabilize the device within the posterior chamber of the eye.

[0018] In related aspects, a device for supporting an intraocular lens within the eye is provided. The device includes a lens support structure having a central aperture. When the device is implanted in the eye, light may be transmitted through the central aperture toward the retina. The device includes at least three fixation arms, each of the at least three fixation arms having a starting portion coupled to the lens support structure and extending outwardly therefrom, and a terminal portion having an anchor for scleral fixation of the device within the eye. Prior to implantation, at least one of the at least three fixation arms is biased toward a folded configuration incorporating a bend between the starting portion and the terminal portion such that the anchor of the terminal portion overlaps at least a portion of the lens support structure.

[0019] The anchor of at least one fixed arm in the folded configuration is positioned over at least a portion of the lens support structure and anterior to the lens support structure with respect to the retina when disposed within the eye and prior to scleral fixation. The anchor positioned over at least a portion of the lens support structure can be above and anterior to the central opening of the lens support structure with respect to the retina. At least a first portion of the anchor can be above and anterior to the central opening, and at least a second portion of the anchor can be above and anterior to the lens support structure with respect to the retina. The anchor of at least one fixed arm in the folded configuration can be positioned under at least a portion of the lens support structure and posterior to the lens support structure with respect to the retina when positioned within the eye and prior to scleral fixation. The anchor positioned under at least a portion of the lens support structure can be below and posterior to the central opening of the lens support structure with respect to the retina. At least a first portion of the anchor can be below and posterior to the central opening, and at least a second portion of the anchor can be below and posterior to the lens support structure with respect to the retina. The folded configuration can include a terminal portion folded over or under the starting portion of at least one fixed arm. The terminal portion of at least one fixed arm in the folded configuration can overlap the starting portion. The anchor of the terminal portion of at least one fixed arm in the folded configuration can be visible through the pupil of the eye when the device is disposed in the posterior chamber of the eye but prior to transscleral fixation of the anchor. The anchor of at least one fixed arm in the folded configuration is positioned within a distance from the central axis of the device, and the central axis extends from anterior to posterior through the central opening. The distance cannot exceed about 4.0 mm. At least one fixed arm in the folded configuration can be curved such that the anchor of the terminal portion of at least one fixed arm projects posteriorly toward the central opening of the device. This anchor can be adapted for sutureless transscleral fixation. The lens support structure can be substantially ring-shaped.

[0020] The lens support structure can further have an outer periphery and an inner periphery. The central opening can be surrounded by the inner periphery. The outer periphery of the lens support structure can be substantially non-circular, and the inner periphery can be substantially circular. The lens support structure can include the outer periphery. The outer periphery can include a plurality of lobes that project radially from the central opening. The first total number (numerical count) of the plurality of lobes can be equal to the second total number of at least three fixed arms. Each lobe can be disposed between adjacent fixed arms. Each lobe can be symmetrically disposed around the outer periphery of the lens support structure between adjacent fixed arms. Each of the at least three fixed arms can be symmetrically disposed around the outer periphery of the lens support structure between adjacent lobes. The plurality of lobes can be composed of three lobes. The at least three fixed arms can consist of three fixed arms. The plurality of lobes can include at least three convex lobes that give the lens support structure a substantially rounded triangular shape. When implanted, the at least three convex lobes can provide non-penetrating contact with the ciliary body tissue in the eye. At least two of the at least three fixed arms can be biased towards a folded configuration prior to implantation. All of the at least three fixed arms can be biased towards a folded configuration prior to implantation. At least a second fixed arm of the at least three fixed arms can be biased towards a deployed configuration prior to implantation. The at least second fixed arm can have a larger cross-sectional area compared to the cross-sectional area of at least one of the at least three fixed arms, and can provide an increase in the rigidity of the at least second fixed arm relative to the rigidity of at least one of the at least three fixed arms. The lens support structure can form a substantially planar surface. The lens support structure can include a shape configured to fit around an intraocular lens and / or one or more haptics of the intraocular lens. The shape can be a recess, a concave portion, a channel, or a groove that forms at least a portion of the inner periphery of the lens support structure.At least one of the at least three fixation arms can include a deformable material to facilitate unbending from a folded configuration to a deployed configuration of the fixation arm to facilitate scleral fixation. After scleral fixation of the anchor, at least one fixation arm can apply tension in the deployed configuration between a starting portion and an end portion to align the lens support structure relative to the Z-plane of the eye.

[0021] The device can include three fixation arms. Two of the three fixation arms can be flexible and biased toward a folded configuration. The third fixation arm can be less flexible than the two flexible fixation arms and can be biased toward a deployed configuration. All three fixation arms are configured to be installed under tension. The folded configuration of each of the two of the three fixation arms can bias the end portion toward the central axis of the device. The lens support structure can be biased toward a substantially flat configuration or a planar configuration while at least one of the at least three fixation arms is biased toward a folded configuration.

[0022] In an interrelated aspect, a device for supporting an intraocular lens in the eye is provided. The device includes a lens support structure having an inner circumferential surface that at least partially defines a central opening. When the device is implanted in the eye, light may pass through the central opening toward the retina. The device includes at least three fixation arms. The at least three fixation arms have a starting portion coupled to the lens support structure and an end portion having an anchor for scleral fixation of the device in the eye. Prior to implantation, at least one of the at least three fixation arms is biased toward a folded configuration. The folded configuration includes a starting portion extending away from the lens support structure, an anchor of the end portion positioned above or below at least one of a portion of the lens support structure and a portion of the central opening, and a bend between the starting portion and the end portion.

[0023] In a folded configuration, the anchor of at least one fixed arm can be positioned within the eye, above and anterior to a portion of the lens support structure with respect to the retina, prior to scleral fixation. In a folded configuration, the anchor of at least one fixed arm can be positioned within the eye, above and anterior to a portion of the central opening with respect to the retina, prior to scleral fixation. At least a first portion of the anchor can be above and anterior to a portion of the central opening, and at least a second portion of the anchor can be above and anterior to a portion of the lens support structure with respect to the retina. In a folded configuration, the anchor of at least one fixed arm can be disposed within the eye, below and posterior to a portion of the lens support structure with respect to the retina, prior to scleral fixation. In a folded configuration, the anchor of at least one fixed arm can be positioned within the eye, below and posterior to a portion of the central opening with respect to the retina, prior to scleral fixation. At least a first portion of the anchor can be below and posterior to a portion of the central opening, and at least a second portion of the anchor can be below and posterior to a portion of the lens support structure with respect to the retina. The folded configuration can include a terminal portion folded above or below a starting portion of at least one fixed arm. The terminal portion of at least one fixed arm in the folded configuration can overlap the starting portion. The anchor of the terminal portion of at least one fixed arm in the folded configuration can be visible through the pupil of the eye when the device is placed in the posterior chamber of the eye but prior to transscleral fixation of the anchor. The anchor of at least one fixed arm in the folded configuration can be positioned within a distance from the central axis of the device, which extends from anterior to posterior through the central opening. The distance cannot exceed about 4.0 mm. At least one fixed arm in the folded configuration can be curved such that the anchor of the terminal portion of at least one fixed arm projects posteriorly toward the central opening of the device. This anchor can be adapted for sutureless transscleral fixation.

[0024] The lens support structure can be substantially ring-shaped. The lens support structure can further include an outer periphery and an inner periphery. The outer periphery can be substantially non-circular, and the inner periphery can be substantially circular. The lens support structure can further include an outer periphery including a plurality of lobes protruding radially away from a central opening. The first total number of the plurality of lobes can be equal to the second total number of at least three fixing arms. Each lobe can be disposed between adjacent fixing arms. Each lobe can be symmetrically disposed around the outer periphery of the lens support structure between adjacent fixing arms. Each of the at least three fixing arms is symmetrically disposed around the outer periphery of the lens support structure between adjacent lobes. The plurality of lobes is composed of three lobes, and the at least three fixing arms are composed of three fixing arms. The plurality of lobes can include at least three convex lobes that give the lens support structure a substantially rounded triangular shape. When implanted, the at least three convex lobes can provide non-penetrating contact with the ciliary body tissue in the eye.

[0025] At least two of the at least three fixing arms can be biased towards a folded configuration before implantation. All of the at least three fixing arms can be biased towards a folded configuration before implantation. At least a second fixing arm of the at least three fixing arms can be biased towards a deployed configuration before implantation. The at least second fixing arm can have a larger cross-sectional area compared to the cross-sectional area of at least one of the at least three fixing arms, and can provide an increase in the rigidity of the at least second fixing arm relative to the rigidity of at least one of the at least three fixing arms.

[0026] The lens support structure can provide a substantially planar surface. The lens support structure can include a shape configured to fit around an intraocular lens or fit with one or more haptics of an intraocular lens. The shape can include a recess, a concave portion, a channel, or a groove that forms at least a portion of the inner periphery of the lens support structure.

[0027] At least one of the at least three fixation arms can include a deformable material to facilitate straightening from a folded configuration to a deployed configuration of the fixation arm to facilitate scleral fixation. After scleral fixation of the anchor, at least one fixation arm can apply tension in the deployed configuration between a starting portion and an end portion to align the lens support structure with respect to the Z-plane of the eye. The device can include three fixation arms. Two of the three fixation arms can be flexible and can be biased toward a folded configuration. A third fixation arm can be less flexible than the two flexible fixation arms and can be biased toward a deployed configuration. The three fixation arms are all configured to be installed in a tensioned state. The folded configuration of each of the two of the three fixation arms can be biased with the end portion toward the central axis of the device. The lens support structure can be biased toward a substantially flat or planar configuration while at least one of the at least three fixation arms can be biased toward a folded configuration.

[0028] In some variations, one or more of the following can optionally be included in any practicable combination in the above methods, apparatuses, devices, and systems. Further details are described in the accompanying drawings and the following description. Other features and advantages will become apparent from the description and drawings.

Brief Description of the Drawings

[0029]

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DETAILED DESCRIPTION OF THE INVENTION

[0030] These and other aspects will be described in detail with reference to the following drawings. Generally, the drawings are not to an absolute scale or a relative scale, but are for illustrative purposes. Also, the relative arrangement of functions and elements can be changed to clarify the description.

[0031] It should be understood that the drawings in this application are for illustrative purposes and are not intended to be to scale.

[0032] This disclosure relates generally to the field of ophthalmology, and more particularly to ophthalmic devices including an artificial support structure that can be used to support an intraocular lens (IOL) or other ophthalmic implant when zonular support and capsular support are compromised.

[0033] The most common treatment for aphakia caused by removal of the cataractous lens is to place an intraocular lens within the native lens capsule. The lens capsule, which is composed of an anterior portion and a posterior portion and forms a lumen, is supported by the zonules and provides a structure for stably supporting the intraocular lens. In some cases, the posterior surface of the lens capsule becomes dysfunctional or ruptures during cataract surgery, requiring a more reliable platform for placement of the intraocular lens. If there is no damage to the anterior surface of the lens capsule and the associated zonules, the intraocular lens may be placed between the anterior capsule and the iris, a location referred to as the "sulcus." In another subset of cataract surgery cases, the non-functionality of the anterior capsule or the zonules renders placement in the sulcus unsafe or impossible. The devices described in this specification can be implanted into the posterior chamber of the eye lacking an intact lens capsule. The devices described in this specification can create an artificial anterior capsule with artificial zonular fixation. The devices described in this specification can provide a stable platform structure fixed to the eye, thereby reproducing the native anterior capsule and zonular device that enables placement of an intraocular lens in an artificially constructed sulcus.

[0034] The devices described in this specification can solve the problems of other support / positioning techniques known in the art. Anterior chamber intraocular lenses placed in front of the iris can cause corneal decompensation, glaucoma, and bleeding over time due to instability within the eye. Lenses sutured to the iris are technically difficult to implant and carry a risk of bleeding and glaucoma due to abrasion of the iris. Lenses may also be sutured to the sclera, which is also technically difficult. In some cases, additional surgery is required due to erosion / breakage of the sutures, with a risk of infection that can potentially lead to blindness.

[0035] The devices described in this specification can be implanted without suturing and can eliminate the risk of suture breakage. With a seamless and scleral fixation method, they can be more easily worn without worrying about suture loosening or breakage, enabling reliable fixation. The devices stably hold an intraocular lens that provides reliable refractive results based on known positions without concern. This device also enables posterior segment placement that significantly reduces the risk of damage to the iris, angle, or cornea. Implantation behind the iris and cornea eliminates or reduces the risk of corneal damage, iris bleeding, and glaucoma. The devices described in this specification reduce the risk of complications compared to current technologies such as ACIOL, iris-sutured lenses, or scleral-sutured lenses. The devices described in this specification are configured to accommodate and support a wide variety of intraocular lenses. Thus, the selected lens can be implanted during surgery or at a later date. The devices described in this specification are particularly suitable for implantation into the posterior chamber of the eye that replicates the native lens capsule and lacks an intact lens capsule. For example, the devices described in this specification can create an artificial anterior capsule with zonular fixation that provides a scaffold or stable platform structure and an artificially constructed groove in which the anterior component of the lens capsule and / or the zonular fibers of the native lens do not function. The fixation arms can be externalized as needed for scleral support / fixation.

[0036] Figures 1-4 illustrate an implementation of device 100. Device 100 can include a lens support structure 105 on, against, or within which an intraocular lens 110 can be supported, a central opening or aperture 115, and one or more fixation arms 120. The central aperture 115 is configured to prevent device 100 from interfering with the patient's vision and to allow light to pass through the central aperture 115 and the intraocular lens 110 disposed on device 100. The size of the central aperture 115 allows light to pass through the device without optical obstruction. The light can pass through the device towards the retina and is only affected by the optical portion of the intraocular lens. The one or more fixation arms 120 can be used to position and stabilize device 100 within the eye. The lens support structure 105 can include an outer perimeter 111 and an inner perimeter 109, and the central aperture 115 can be bounded by the inner perimeter 109. The lens support structure 105 can be generally ring-shaped, although the outer perimeter 111 of the lens support structure 105 need not be circular, as will be described in more detail below. The outer perimeter 111 of the lens support structure is substantially non-circular, and the inner perimeter 109 is substantially circular.

[0037] FIG. 1 shows a top view of a device 100 showing a lens support structure 105, a central opening 115, and a fixation arm 120. FIG. 2 shows a model of an eye having a 3 / 4 view of the device 100 deployed to support an intraocular lens 110 (the iris is shown as transparent). The lens support structure 105 can function as a support for the intraocular lens 110 during optimal implantation and can also function as a guard against the intraocular lens 110 dropping into the posterior chamber during implantation. The lens support structure 105 can replace the native lenticular lens capsule, particularly when the anterior surface and associated zonules are not helpful and the sulcus placement of the intraocular lens is dangerous or impossible. By placing the lens support structure 105 in a patient without an appropriate lens capsule, a lens anterior capsule device can be created. The fixation arm 120 can provide artificial zonular fixation to stabilize the lens support structure as a stable platform for placing the intraocular lens within an artificially constructed groove. FIG. 3 shows a cross-sectional view of a model of an eye and the device 100 deployed to support the intraocular lens 110. FIG. 4 shows a model of an eye in cross-section showing how the lens is positioned to support the intraocular lens using optic capture technology. FIG. 4 shows the cornea 5, iris 10, ciliary body 15, sclera 20, ciliary sulcus 25, and pupil 30 defined at the center of the iris 10.

[0038] In some examples, the support structure 105 can be substantially flat or planar. The support structure 105 can have an anterior-facing surface 1210 that faces forward of the eye when the support structure 105 is in use and a posterior-facing surface 1215 that faces rearward of the eye when the support structure 105 is in use (see FIG. 17E). The planar support structure 105 can function as a platform on which an intraocular lens can be placed. The planar front and rear surfaces need not include protrusions, channels, or capture components for holding the intraocular lens thereto. For example, the support structure 105 can form an artificial anterior eye portion of the lens capsule in which the intraocular lens is disposed, but need not hold the intraocular lens within the inner surface. Thus, the intraocular lens can remain entirely external to the support structure 105 during use, and apart from the substantially planar surfaces of the support structure 105, no protrusions, overhangs, or other surfaces for the intraocular lens are disposed. Thus, each of the anterior-facing surface and the posterior-facing surface can be a substantially smooth plane with no protrusions or overhangs on the surface. It can also be ensured that there are no depressions, grooves, divots, or openings other than the central opening 115 extending therethrough in each of the anterior-facing surface and the posterior-facing surface. The substantially flat support structure 105 can taper toward the central opening 115. The tapered edge or inner wall 109 defining the central opening 115 has an anteroposterior thickness that is thinner than the anteroposterior thickness of the support structure away from the central opening 115.

[0039] In other examples, the support structure 105 can incorporate one or more protrusions that extend away from at least one of the front facing surface and the rear facing surface. FIGS. 19A-19C show an example of a support structure 105 having a plurality of posts 106 that project upwardly from the front facing surface near the central opening 115. The plurality of posts 106 can be arranged around the central opening 115 so as to surround the optical portion of the intraocular lens when the intraocular lens is disposed over the central opening 115 (see FIGS. 19B-19C). The posts 106 can be adjacent to or lie adjacent around the perimeter of the optical portion so that the intraocular lens is received and centered by the posts 106 to limit translational and / or rotational movement of the intraocular lens relative to the support structure 105. The posts 106 are also disposed on the front facing surface (or the rear facing surface) so as to engage an area of the haptics of the intraocular lens that extends outwardly from the optical portion. The posts 106 can be arranged to generally accommodate most intraocular lens designs.

[0040] In yet other examples, the support structure 105 can optionally or additionally include a recess in at least one of the front facing surface or the rear facing surface that is dimensioned and shaped to receive the intraocular lens (see FIGS. 20A-20C. Details are described below). The recess can be a central inwardly facing groove for receiving the intraocular lens and / or the haptics of the intraocular lens, as described, for example, in PCT International Publication No. WO2020 / 086312, published April 30, 2020, which is incorporated herein by reference.

[0041] Figures 20A - 20C show another example of a device 100 having a support structure 105 that includes a recess 104 within the front facing surface. The recess 104 can form a lip surrounding a central opening 115, and the lip is dimensioned to engage and support around the perimeter of the optical portion of the intraocular lens relative to the lip (see Figure 20C). The recess 104 in the central 6.0 - 7.0 mm portion of the support structure 105 can limit the translational movement of the optical portion. The recess 104 can further incorporate a portion cut out in a concave shape to increase the interface area with the support structure 105 of the intraocular lens. The recess 104 can further incorporate one or more features to prevent rotational movement about the visual axis or central axis CA of the device. Figures 24A - 25F, 25A - 25C, and 26A - 26E show additional examples of devices incorporating recesses into which the intraocular lens is received and are described in more detail below.

[0042] Regardless of whether the support structure 105 is recessed and / or incorporates one or more protrusions from its surface, the thickness of the support structure 105 in the anterior - posterior direction is minimized to avoid impact on the iris 10.

[0043] The support structure 105 can include one or more surface features within or on the anterior facing surface 1210 and / or the posterior facing surface 1215. Figure 1 shows that the support structure 105 can include a surface feature 118 on the anterior facing surface 1210 that is used to position the device 100 during implantation. The surface feature 118 can be engaged by forceps or other implantation tools to assist in manipulating the device 100 during implantation.

[0044] The central opening 115 can extend through the entire thickness of the support structure 105 from the front facing surface 1210 to the rear facing surface 1215 such that the support structure 105 further includes an inner wall 109 having an inner circumferential surface that defines the central opening 115 and an outer wall 111 having an outer circumferential surface that defines the overall shape of the support structure 105 (see also FIGS. 1 and 17E). Thereby, a substantially ring shape can be provided to the lens support structure 105. However, the ring-shaped lens support structure 105 does not necessarily have to have both its inner and outer circumferential surfaces circular. The inner circumferential surface has a circumference and can form a uniform and substantially circular shape, while the outer circumferential surface can form a substantially non-circular shape. As will be described in more detail later, the non-circular shape of the outer circumferential surface consists of a plurality of lobes 107 that protrude outwardly from a plurality of sides 108. The plurality of lobes 107 can project radially away from the central opening 115. The plurality of sides 108 can be substantially flat or concave as described elsewhere in this specification. In some examples, the device includes at least three fixation arms 120 coupled to the lens support structure 105 configured to be under tension to position and stabilize the device within the eye. Each of the three fixation arms 120 can extend outwardly from one of each of the plurality of sides 108. Thus, the width between the outer and inner circumferential surfaces of the lens support structure 105 can vary circumferentially. The central opening 115 is configured to be visible through the device. In some examples, the support structure 105 is substantially flat and the intraocular lens seats on the front facing surface (or rear facing surface) of the support structure 105 but is not held or contained by the central opening 115. In other examples, the support structure 105 is substantially planar but includes a recess 104 surrounding the central opening 115 such that an intraocular lens seated on the front facing surface of the support structure 105 engages a lip formed by the recess 104 (see FIG. 20C). The support structure (and thus the central opening 115) can have a minimized thickness from front to back. The thickness of the support structure 105 between the front facing surface 1210 and the rear facing surface 1215 can be between about 0.15 mm and 1.5 mm, or between about 0.5 mm and 1.0 mm.The thickness of the support structure 105 can be thinner than 0.15 mm. For example, even when the fixed arm 120 is under tension, sufficient support for the intraocular lens can be provided. The inner peripheral surface or inner wall 109 that defines the central opening 115 can be smooth and free of any recesses, grooves, channels, or other surface features. In some examples, the inner peripheral surface or inner wall 109 is convex and protrudes towards the central axis CA of the device. The outer peripheral surface or outer wall 111 is convex and protrudes away from the central axis CA of the device. The convex inner and outer peripheral surfaces formed by the inner wall 109 and the outer wall 111 can create the cross-sectional shape of the support structure 105 when crossing the center of the central opening 115 that forms a pair of round rods. In some examples, each of the front facing surface 1210 and the rear facing surface 1215 tapers towards the central opening 115 such that the inner peripheral surface of the inner wall 109 is formed as a narrow ridge or point 1230 that protrudes towards the central axis CA of the device (see FIG. 17E).

[0045] The central opening 115 may be the only opening that extends through the support structure 105 such that the support structure 105 has only one opening that extends through its entire thickness. The inner diameter of the central opening 115 is configured to be generally universal for a wide range of intraocular lens types. The central opening 115 is dimensioned to avoid substantial overlap of the support structure 105 with the optical portion of the intraocular lens. Conventional intraocular lenses generally have an optical portion with an outer diameter of 6 mm, but this size varies depending on the intraocular lens. Devices with an inner diameter of the central opening 115 that is less than 5.0 mm to about 4.0 mm can be used with some intraocular lenses. Devices having an inner diameter of the central opening 115 of 5.0 mm to about 6.0 mm can be used with most intraocular lenses such that they can be used almost interchangeably with any conventionally haptically stabilized intraocular lens. The minimum inner diameter of the central opening 115 can be greater than about 4.0 mm, greater than about 4.5 mm, greater than about 5.0 mm, greater than about 5.5 mm, greater than about 6.0 mm, greater than about 6.5 mm, up to about 7.0 mm, up to about 8.0 mm, up to about 9.0 mm, up to 10 mm, and any range therebetween.

[0046] The inner diameter of the central opening 115 can be larger than the outer diameter of the optical portion of the intraocular lens. FIGS. 21A-21B illustrate an example of a device 100 having a central opening 115 with an inner diameter larger than that of the optical portion of most intraocular lenses. The device 100 can include a plurality of leaflets 126 configured to support the optical portion of the intraocular lens. The leaflets 126 can project inwardly so as to extend within the opening of the central opening 115. The leaflets 126 can support the optical portion at its front facing surface or can be deflected such that the optical portion passes through the rear facing surface of the leaflets 126 and is supported at the rear facing surface of the leaflets 126. The haptic of the intraocular lens remains on the front facing surface of the support structure 105, and the optical portion of the intraocular lens is positioned on the rear facing surface of the leaflets 126, thereby maintaining the Z position of the intraocular lens. The leaflets 126 can be of full thickness or partial thickness. What is meant is that the leaflets 126 can be of the same thickness as the support structure 105 or can be thinner than the support structure 105. The leaflets 126 can originate from the front facing surface of the support structure 105 (see FIG. 21A). The leaflets 126 can also originate from the rear facing surface of the support structure 105 (see FIG. 21B). When originating from the rear facing surface, the optical portion of the intraocular lens is positioned within a recess formed by the central opening 115 and the front facing surface of the leaflets 126. The device 100 can include one, two, three, or more leaflets 126. In an example, the device 100 includes three leaflets 126 and three fixed arms 120. Each of the three leaflets 126 can be symmetrically positioned around the support structure 105 such that each leaflet 126 is substantially aligned with one of the respective origins of the fixed arms 120. FIGS. 21A-21B show that each of the bent fixed arms 120a, 120b curves around from its origin at the support structure 105 and is substantially positioned over its respective leaflet 126. The leaflets 126 can define an inner diameter narrower than the inner diameter of the central opening 115.The narrower inner diameter of the leaflet 126 can be from about 4.0 mm to 6.0 mm, or from about 5.0 mm to 5.5 mm, or about 5.0 mm. Each leaflet 126 can have a thickness from about 0.10 mm to 0.50 mm, or from about 0.15 mm to about 0.35 mm, or about 0.25 mm.

[0047] One or more of the fixing arms 120 can be made substantially straight between their origins having the support structure 105 and their termini. The straight fixing arm or leading fixing arm 120 can extend along one longitudinal axis L between the origin 103 and the terminus 102 without bending or curving away from one longitudinal axis L (see FIGS. 17A - 17B). The straight fixing arm 120 can extend orthogonally to the outer peripheral surface of the outer wall 111 of the support structure 105. The longitudinal axis L of the straight fixing arm 120 can be arranged orthogonally to the outer peripheral surface of the outer wall 111. The plane of the front facing surface 1210 of the support structure 105 and the longitudinal axis L of the straight fixing arm can be made parallel to each other, and the plane of the rear facing surface 1210 of the support structure and the longitudinal axis L can also be made parallel to each other.

[0048] One or more fixation arms 120 can be made of a reinforced membranous fixation arm configured to be externally exposed without trauma and held in place only by its shape and mechanical properties (i.e., without the need for sutures or adhesives). An externalization portion or anchor 125 (also referred to herein as an anchor footplate or footplate) at the peripheral end of the fixation arm 120 (also referred to herein as the terminal or terminal portion) can be seated subconjunctivally to fix the fixation arm 120 in a predetermined position. The anchor 125 of the fixation arm 120 can have a robust yet thin shape so as to maintain a stable state, not re-enter the eye, and minimally erode the conjunctiva. Further, the fixation arm 120 of the device 100 may be manufactured to facilitate visualization and manipulation of the device prior to surgery. At least one of the fixation arms 120 can be manufactured to have a substantially non-planar shape during installation and then be manipulated into a planar configuration, for example, when under tension, during the implantation procedure.

[0049] The device 100 can include one, two, three, or more fixation arms 120. In a preferred example, the device 100 includes three fixation arms 120 that are symmetrically or equidistantly positioned around the outer periphery of the support structure 105. The fixation arms 120 can provide sufficient support for long-term stability about the lens support structure 105. In some examples, this is achieved by one fixation arm 120. In other examples, one or more fixation arms include three fixation arms 120 that are symmetrically positioned around the outer periphery of the lens support structure. The fixation arm 120 can be composed of a semi-rigid material or can have a shape that provides sufficient structural rigidity.

[0050] Device 100 can also include exactly two fixation arms 120. These fixation arms 120 can be under equal and opposite tensions when implanted and fixed scleral-ly. Alternatively, the fixation arms 120 may be asymmetric such that one fixation arm 120 is under tension and the other fixation arm 120 has the stiffness and length to function as a rigid spacing element. The fixation element, which can be rigid or apply a spring force, may depend on penetrating adjacent tissue or being pushed into a predetermined position. The tensioned fixation element may, once placed, depend on slight elongation or expansion of the material. One or both of the fixation arms 120 are generated in an inner biasing configuration where the fixation arm is biased towards a forward projecting curvature or a folded configuration, as described elsewhere in this specification. The fixation arm 120 can have a paddle-like shape that resists rotation when engaged with eye tissue.

[0051] Device 100 can also include three or more fixed arms 120. The three fixed arms 120 can provide the device 100 with a fixed plane defined substantially parallel to the Z-plane (vertical plane) of the eye. The fixed arms 120 can be configured and deployed to provide equal and opposite tension to each fixed arm 120. Alternatively, one or more fixed arms 120 are configured to have the rigidity and length to act as a rigid spacing element. All of zero, one, two, or three or more fixed arms 120 are manufactured in a configuration biased inwardly or biased toward the center of the device or the central axis CA of the device (see FIGS. 10-13, FIGS. 17B-17E, FIG. 19A, FIG. 20A, FIGS. 21A-21B, FIGS. 22A-22B, FIGS. 23A-23B, FIGS. 24A-24F, FIGS. 25A-25C, FIGS. 26A-26E). The fixed arms 120 biased inwardly extend from the support structure and can have a folded configuration prior to implantation. At least one (but not all) of the fixed arms can be biased or curved as described in this specification. At least two (but not all) of the fixed arms can be biased or curved as described in this specification. In some examples, all of the fixed arms 120 can be biased or curved. The device can include three fixed arms, two of which are flexible and biased toward a folded configuration, and a third fixed arm is less flexible than the other two fixed arms and is biased toward a deployed configuration. Each folded configuration of the fixed arms biases the terminal portion of the fixed arm toward the central axis CA of the device. While the fixed arms are biased toward a folded configuration that is not substantially flat or planar, the lens support structure is biased toward a configuration that is substantially flat or planar.

[0052] Once implanted and fixed transsclerally, the inwardly biased arms can straighten or deploy away from their folded and inwardly biased configuration. In a preferred example, the two fixed arms 120 have an inward bias shape, and the third fixed arm 120 has an increased cross-sectional area to increase its rigidity. The inwardly biased fixed arms 120 can incorporate a bend between the origin and the terminus of the arms having the lens support structure 105. The two bent fixed arms 120 are biased towards the folded configuration towards the central axis CA of the device.

[0053] In one example, the device 100 can include at least three fixed arms 120. Prior to implantation, one of the at least three fixed arms can extend from the support structure in a deployed configuration, and at least two of the at least three fixed arms can extend from the support structure in a folded configuration. Also, prior to implantation, one of the at least three fixed arms can be biased towards the deployed configuration and at least two of the at least three fixed arms can be biased towards the folded configuration. After implantation, each of the arms biased towards the folded configuration can be deployed.

[0054] Each of the fixation arms 120 can include a starting portion 103 of the support structure 105 and a terminal portion 102 coupled to a trauma-free anchor 125 for seamless and scleral fixation. Prior to scleral fixation of the anchor 125, one (up to all) of the plurality of fixation arms 120 can include a curved fixation arm 120 that curves between the starting portion 103 and the terminal portion 102 to form a bend B (see FIGS. 22A-22B) that allows visualization of at least a portion of the curved fixation arm 120 through the pupil 30 of the eye (see FIG. 13). After scleral fixation of the anchor 125, each of the plurality of fixation arms 120 can have tension applied between the starting portion and the terminal portion to align the support structure with respect to the Z-plane of the eye. The support structure 105 is configured to support an intraocular lens. A central opening 115 extending through the entire thickness of the support structure 105 is configured to allow light to pass through both the central opening 115 and the intraocular lens supported by the support structure 105. The curved fixation arm 120 can curve forward such that a portion of the arm 120, such as the terminal 102 and / or its trauma-free anchor 125, is positioned over at least a portion of the support structure 105 (e.g., over the top surface of the support structure 105 and / or over the region of the central opening 115). Alternatively, the curved fixation arm(s) 120 can curve backward such that a portion of the arm 120, such as the terminal 102 and / or its trauma-free anchor 125, is positioned under at least a portion of the support structure 105 (e.g., under the bottom surface of the support structure 105 and / or under the region of the central opening 115).

[0055] Figures 19A and 20A show examples of the device before implantation. Figures 19B - 19C and 20B - 20C show the device after implantation. Two of the three fixed arms 120 are curved inwardly so as to be biased towards a folded configuration at rest. The arms 120 extend outwardly substantially at right angles from the support structure 105 (such as from their origins 103 in the support structure 105), creating a bend (either forward or backward) that forms a curvature between the origin 103 and the end 102 of the arm 120. Due to the curvature of the arm 120, the end 102 of the arm 120 will be positioned closer to its own origin portion 103. In some examples, the arm 120 curves forward such that the end 102 of the arm 120 is positioned in front of the origin portion 103 of the arm, or on at least a portion of the front facing surface of the support structure 105 near the origin portion 103 of the arm. In other examples, the arm 120 can curve backward such that the end 102 of the arm 120 is positioned behind the origin portion 103 of the arm, or under at least a portion of the rear facing surface of the support structure 105 near the origin portion 103 of the arm. In an example, the anchor 125 of the curved fixed arm 120 can curve away from the first plane of the support structure (e.g., the Z - plane of the eye) and into a second plane parallel to the first plane. The second plane can be in front of or behind the first plane depending on whether the arm 120 curves forward or backward. The curvature can be substantially in the lateral direction (e.g., the X - plane) with respect to the plane of the lens support structure 105 (e.g., the Z - plane). The diameter of the dilated pupil (depending on adult or pediatric patient) is up to about 8 mm maximum. The curvature is such that the anchor 125 of the curved fixed arm 120 is positioned within the diameter of a circle in a second plane that can be seen within the diameter of the dilated pupil so as not to interfere with visualization by the opaque iris, for example, from about 3 mm to about 7.5 mm, more preferably about 7 mm. Each anchor 125 of the curved fixed arm 120 can be positioned at a distance not exceeding, for example, about 1.5 mm, about 2.0 mm, about 2.5 mm, about 3.0 mm, about 3.5 mm from the center of the device, or a distance not exceeding about 4.0 mm.The curved fixing arm 120 provides for positioning the end portion 102 and / or the anchor 125 within this diameter or this distance from the center of the device that enables easy visualization. The third fixing arm of the three fixing arms 120 is straight or biased towards the deployed configuration during installation. The third fixing arm 120 extends outwardly at a right angle from the origin 103 in the support structure 105 and does not turn or bend. Rather, the entire third fixing arm 120 is completely straight and extends substantially along one axis. The two fixing arms that are biased towards the folded configuration during installation become the deployed configuration, for example, by applying tension to the arm 120 via an externalized reinforcing membrane anchor.

[0056] The fixing arms 120 may be evenly positioned around the device 100 to provide uniform tension. Alternatively, the fixing arms 120 may be oriented in a non-uniform arrangement, for example, using three fixing arms 120 that are 90 degrees to each other. In this situation, two of the fixing arms 120 are 180 degrees to each other and provide opposing tension. On the other hand, the third fixing arm 120 mainly serves to prevent the device 100 from rotating.

[0057] The lens support structure 105 can provide several functions. The lens support structure 105 can have a surface (front facing surface 1210 or rear facing surface 1215) that forms a stable platform on which the intraocular lens 110 can be placed during use. The lens support structure 105 can replace the lens capsule, particularly when the posterior and / or anterior side surfaces of the lens capsule are ruptured or otherwise dysfunctional. Its geometric and mechanical functions can not only support the intraocular lens 110 when in use, but also assist in centering the intraocular lens 110 in the case of an asymmetric eye or an asymmetric surgical procedure. The lens support structure 105 is coupled to one or more fixation arms 120. When the lens support structure 105 provides artificial anterior capsule support for the intraocular lens, the fixation arms 120 provide an artificial zonular device. Thus, the device provides a stable platform structure fixed to the eye that replicates the native anterior capsule and ciliary zonular device that normally enables placement of the intraocular lens. The shape and mechanical properties of the lens support structure 105 are configured to withstand torsional forces or tensions that may be imparted by the fixation arms 120 and allow the fixation arms 120 to function as intended.

[0058] The fixation arms 120 and the lens support structure 105 are configured to position the central opening 115 such that the properly fixed device 100 does not interfere with the patient's vision. The surgeon can place the intraocular lens 110 through the lens support structure 105, thereby providing the refractive correction needed by the patient.

[0059] The ciliary body is substantially circular or oval, and the longitudinal axis is on average 0.5 mm longer than the transverse axis. The lens support structure 105 can interact with the patient's ciliary body to provide centering of the device 100 within the eye. The substantially circular or oval lens support structure 105 can similarly provide centering with the circular or oval ciliary body. However, shaping and 360-degree contact between the lens support structure 105 and the ciliary body can lead to inflammation and damage and may have an adverse effect on lens formation. In a preferred example, the lens support structure 105 has a continuous inner circumferential surface forming a uniform and substantially circular inner wall 109 that defines a central opening 115, and an outer circumferential surface forming a substantially non-circular outer wall 111 that gives the lens support structure 105 a substantially non-circular shape (see FIG. 1). The non-circular outer peripheral shape of the lens support structure 105 can provide centering of the device 100 without 360-degree contact with the ciliary body along the substantially non-circular outer circumferential surface. The shape of the lens support structure 105 can provide sufficient contact between the lens support structure 105 and the ciliary body to assist in centering and supporting the intraocular lens 110 without causing inflammation and damage. In some embodiments, the shape of the lens support structure 105 allows for contact with the ciliary body that is about 120 degrees or less, preferably 1 degree to 45 degrees, or 1 degree to 20 degrees. Limiting the contact to 120 degrees or less can significantly reduce the risk of inflammation and impairment of aqueous humor production. The substantially non-circular or oval lens support structure 105 allows for gentle contact between the device 100 providing centering and the ciliary body without the need to exactly match the specific dimensions of the patient. The radius of curvature of the lens support structure 105 can be smaller than the radius of curvature of the ciliary body protrusion. Thus, the lens support structure 105 can contact the ciliary body protrusion at three separate points rather than over a calculable range. For example, during use, the substantially non-circular outer circumferential surface of the lens support structure 105 can contact the ciliary body protrusion at these three separate points. In other examples, when each fixation arm 120 is implanted and under tension, the lobe 107 of the device 100 is positioned near the eye tissue (e.g., the ciliary body) but avoids contacting the eye tissue.With this configuration, the lobe 107 helps center the device, while avoiding excessive tension being applied to one arm 120 relative to the other arm 120. If the fixed arm 120 is pulled too much during the externalization of its anchor 125, the adjacent lobe 107 on either side of the fixed arm 120 may lean against the ciliary body during implantation, moving the support structure 105 away from the ciliary body and facilitating more central alignment of the device 100. Once implanted, the lobes 107 of the device are positioned near the eye tissue (e.g., the ciliary body), whether touching or not touching the eye tissue. The tensioned fixed arm 120 can pull the support structure 105 substantially evenly around it. The tension applied around the support structure 105 enables the central axis CA of the device 100, which extends through the central opening 115, to be substantially aligned with the visual axis of the eye and stabilizes the plane of the support structure 105 to be substantially parallel to the Z-plane (vertical plane) of the eye. The central axis CA of the device 100 does not need to be perfectly aligned (coincide) with the visual axis of the eye.

[0060] The non-circular outer wall 111 of the lens support structure 105 can include a plurality of lobes 107 that project outwardly (i.e., convexly) from a plurality of side surfaces 108 that are substantially flat or concave. Thereby, an outer wall 111 of the lens support structure 105 having an alternating pattern of convex lobes and concave or flat side surfaces can be formed. In a preferred example, the lens support structure 105 can include three convex lobes 107 or rounded corners that project between three flat or slightly concave side surfaces 108 that provide a triangular or rounded triangular shape to the lens support structure 105 (see FIG. 1). The lobes 107 can act as bumpers against the ciliary body 15 and / or within the ciliary sulcus 25 to provide a function of preventing rotation within the Z-plane and / or preventing displacement within the Z-plane, and can maintain proper alignment between the central opening 115 and the visual axis of the eye (see FIG. 4). The plurality of fixing arms 120 can be arranged on the side surfaces 108, and the plurality of lobes 107 project outwardly between the plurality of fixing arms 120. Each of the fixing arms 120 can be made longer than the distance by which the lobes 107 project outwardly. As described above, the lens support structure 105 can have a circular inner wall 109 that defines the central opening 115. The plurality of lobes 107 that project outwardly from the central opening 115 provide a varying thickness in the plane of the central opening 115 between the inner wall 109 and the outer wall 111. The thickness of the lens support structure 105 between the inner wall 109 and the outer wall 111 at the position of the substantially flat side surface 108 is thinner than the thickness of the lens support structure between the inner wall 109 and the outer wall 111 at the position of the lobe 107. The number of lobes 107 that form the rounded corners of the lens support structure 105 can be changed to provide the lens support structure with any of various non-circular shapes including rounded triangles, rounded quadrilaterals, rounded pentagons, rounded hexagons, three-leaf types, four-leaf types, five-leaf types, etc. These non-circular protrusions and corners can be rounded to provide a gentle and non-penetrating contact to the ciliary body tissue such as the ciliary body. Alternatively, the device 100 can be configured to utilize the ciliary body flat part or the scleral wall to assist centering. In this example, the device 100 can be arranged behind the ciliary body protrusion.

[0061] The plurality of lobes 107 can include at least three convex lobes that give the lens support structure 105 a substantially rounded triangular shape. A first numerical count of the plurality of lobes 107 can be equal to a second numerical count of at least three fixed arms 120, and each of the lobes 107 is positioned between adjacent fixed arms 120. The lobes 107 can be positioned symmetrically around the outer periphery of the lens support structure between adjacent fixed arms. Each of the at least three fixed arms 120 can be positioned symmetrically around the outer periphery of the lens support structure 105 between adjacent lobes 107.

[0062] Each fixed arm 120 can have a spring force that is a function of the elongation of the material when loaded. In contrast, an open-loop haptic or coil spring can have a spring force provided by the bending of a material having a substantially constant length. The fixed arm 120, once fixed to the eye, can be subjected to tension and elongation of the material. For example, each fixed arm 120 can provide an expansion over a radius between about 7.5 mm and about 8.0 mm to accommodate a diameter between about 15 mm and about 16 mm. The device has an operable tension range for its function. As an example, the device, when implanted, can receive a first amount of tension (X-tension). The first amount of tension is the amount of tension at the minimum allowable diameter. In other words, the device can be under a minimum amount of tension for functionality but can be under a greater amount of tension to accommodate a larger diameter. In an example of a fixed arm 120 that can accommodate both 15 mm and 16 mm of elongation, each force transfer arm can operate under a first tension X and at least under a second tension. The second tension can be the sum of the first tension X plus a tension at a certain distance from the first tension X (e.g., a tension of 0.5 mm). The fixed arm can withstand the tension difference available at each elongation ratio. To further illustrate with an example, if the length of each fixed arm 120 in this example is about 4 mm, the second tension (X-tension + 0.5 mm of tension) can function at a diameter of 15 mm and may increase the elongation by 12.5% to function at a maximum diameter of 16 mm. If the fixed arm 120 in this example has a length of 2 mm, the second tension (X-tension + 0.5 mm of tension) can increase the elongation by 25% to function at a diameter of 15 mm and at a maximum diameter of 16 mm. If the length of the fixed arm in this example is about 6 mm, the second tension (X-tension + 0.5 mm of tension) can increase the elongation by 6.25% to function at a diameter of 15 mm and at a maximum diameter of 16 mm. Since the tension of the anchor on the eye tissue is not overly dependent on variables (eye-specific dimensions and specific location of the incision) that are difficult for the surgeon to evaluate, a decrease in the spring force of the fixed arm 120 can improve the safety and functionality of the device.Furthermore, not only the length of the fixation arm (e.g., between about 2 mm and about 6 mm), but also the inward curvature (forward or backward) of at least one or more fixation arms 120 improves access and visualization for the surgeon to find and fix the arm during surgery.

[0063] With only one, two, or three fixation arms 120 engaged, the intraocular lens 110 can be made to pass between the device 100 and the ciliary processes. The lens support structure 105 configured to contact or substantially contact the ciliary body can also reduce the risk of losing the intraocular lens 110 in the posterior chamber during surgery.

[0064] The lens support structure 105 can be constructed such that the surgeon can use an "optical capture" technique for implantation of the intraocular lens 110 supported by the device 100. In this technique, the optical portion 112 of the intraocular lens 110 passes partially or completely through the central opening 115 of the device 100, while the haptic 114 of the intraocular lens 110 remains substantially in front of the device 100 (see FIG. 3). This technique ensures that the intraocular lens 110 is securely fixed so as not to move in the directions of the X-axis, Y-axis, and Z-axis after surgery, and can reduce the bulk of the space in front of the lens. This technique further enables the safe use of "square edge" intraocular lens designs by reducing contact of the intraocular lens with the posterior surface of the iris 10. The surgeon has additional flexibility when changing the intraocular lens power by being able to select an effective position for the lens. This technique also enables the use of astigmatic correction intraocular lenses by restricting rotation of the intraocular lens. In some situations, there can be limited space between the front surface of the lens support structure 105 and the posterior surface of the iris 10. To reduce the risk of iris damage or pupil block, it may be advantageous to fix the intraocular lens 110 above or behind the plane of the lens support structure 105. Furthermore, by fixing the optical portion while enhancing the predictability of the refractive position, the preoperative lens selection calculation becomes more accurate.

[0065] To facilitate the use of optical capture techniques, the lens support structure 105 can enable a surgeon to pass the intraocular lens 110 through the central opening 115 of the device 100. The central opening 115 can have a diameter similar to that of the optical portion of a typical intraocular lens, e.g., at least 5.5 mm or 6.0 mm. In this situation, the surgeon can pass the intraocular lens 110 through the central opening 115 by applying a force parallel to the optical axis or by slightly tilting the intraocular lens 110 to facilitate its passage through the central opening 115. The central opening 115 can have an inner diameter greater than 5 mm, e.g., from about 5.5 mm, 6.0 mm, 6.5 mm, 7.0 mm, 7.5 mm, 8.0 mm, 8.5 mm, 9.0 mm, 9.5 mm, and 10.0 mm up to about 15 mm, and anywhere in between.

[0066] Alternatively, device 100 can incorporate features that enable it to temporarily expand the diameter of central opening 115 such that intraocular lens 110 can pass through central opening 115. Support structure 105 can have a discontinuous outer peripheral wall and inner peripheral wall such that support structure 105 forms a split ring having a gap between the ends of the ring. In this example, the inner diameter of central opening 115 can vary depending on whether the ends of the ring are compressed or separated from each other. In another example, the outer peripheral wall can be a complete ring or continuous circumference, and the inner peripheral wall defining central opening 115 can be discontinuous or continuous. One central opening can have a continuous inner circumference without a gap, groove, or channel. Alternatively, one central opening can have a discontinuous inner circumference. FIG. 5 shows an example of device 100 having one or more slits 113 formed in inner wall 109 that defines central opening 115. Device 100 can include a plurality of slits 113, such as from 2 to 40 slits 113, circumferentially located in inner wall 109 around central opening 115. Slits 113 can preferably have a length sufficient to extend radially outward from the inner diameter of central opening 115 by 0.25 mm to 2.0 mm, thereby enhancing the flexibility of support structure 105. Intraocular lens 110 can pass through flexible support structure 105. Alternatively, device 100 can incorporate one or more flexible flaps 116 formed in lens support structure 105 (see FIG. 6). Device 100 can include two or more flexible flaps 116, such as from 2 to 40 flaps 116, that flex when sufficient force is applied by a surgeon to enable intraocular lens 110 to pass through central opening 115. Alternatively, inner wall 109 can have a brush-like structure that flexes when sufficient force is applied by a surgeon to allow intraocular lens 110 to pass through. In a further example, the cross-sectional thickness profile of lens support structure 105 can be tapered towards central opening 115.The outer peripheral portion of the lens support structure 105 close to the outer wall 111 will have a greater thickness (e.g., the thickness measured from the front to the back when the device is placed in the eye) than the thickness of the inner peripheral portion of the lens support structure 105 close to the inner wall 109. Thus, the most central portion of the lens support structure 105 (i.e., the inner wall 109) will have greater flexibility due to its reduced thickness such that when under sufficient force, the intraocular lens 110 can pass through the central opening 115 and flex the inner wall 109. Regardless of whether it is due to the slit 113, the flap 116, or the reduced thickness, the lens support structure 105 has sufficient strength to support the intraocular lens 110 placed on the front surface of the lens support structure 105 or an intraocular lens that is partially or completely posterior to the lens support structure 105, despite the greater flexibility near the inner wall 109.

[0067] Figures 7A and 7B illustrate various fixation arms 120 having a terminal footplate or anchor 125. The anchor 125 can be coupled to or located at the outer terminal of the fixation arm 120. These shapes are configured such that they can be easily externalized by a surgeon and stabilize the tension of the device throughout its service life. The anchor 125 can generally have a low profile and can have a shape (e.g., a rounded shape) configured to limit conjunctival erosion and eyelid irritation. The terminal of the fixation arm 120 can have an anchor 125 configured to be located outside the sclera 20 to fix the lens support structure 105 and prevent centripetal slippage. Due to the shape of the anchor 125, a surgeon can pass the anchor 125 through a puncture or incision in the sclera 20 using forceps, a trocar, or other surgical instruments. The snare device for removing the anchor will be described in more detail below. The anchor 125 can have a shape similar to a nail head, a T-bar, or a multi-branched shape, or can preferentially pass through the sclera 20 in a first direction and be resistant to being pulled out in the insertion direction to maintain its external position when the arm 120 is under the tension expected throughout the life of the device. The anchor 125 is configured to have a profile and shape that does not irritate the eyelids or conjunctiva throughout the service life of the device 100. Therefore, preferred shapes have a profile of minimal thickness with smooth, rounded, and / or tapered edges. The anchor 125 can have a substantially constant thickness or, as described in more detail below, can have varying thicknesses over its length.

[0068] The anchor 125 described in this specification is easy to externalize and is configured to resist re-internalization after externalization. The anchor is configured to be graspable using an ophthalmic tool (e.g., 23 gauge, 25 gauge, or 27 gauge). The ideal shape for grasping with an ophthalmic tool is not necessarily ideal for secure fixation. FIGS. 8A-8C show additional shapes of the anchor 125 with different thicknesses, widths, and / or heights. The anchor 125 can include a central portion 1255 and one or more graspable portions 1257 around the central portion. The central portion 1255 can be arranged to be located over the wound (sclerotomy) into which the anchor 125 is inserted, and the graspable portion 1257 is arranged adjacent to the wound. The central portion 1255 can have an increased thickness, height, and / or width compared to the surrounding graspable portion 1257. The increased thickness, height, and / or width of the central portion 1255 adds bulk to the area over the wound, thereby reducing the likelihood that the tension of the fixation arm pulls the anchor 125 back through the wound. The central portion 1255 of the anchor 125 may have a thickness TC along the longitudinal axis L of the arm 120 that is thicker than the thickness TG of the graspable portion 1257. For example, the thickness TC can be about 1.2 to 5.0 times the thickness of the graspable portion 1257. In other examples, the central portion 1255 may have a width or height that is about 1.2 to 5.0 times the width or height of the graspable portion 1257. The shape of the bulky portion is configured to resist deformation when tension associated with normal use of the device is applied. The bulky central portion 1255 can be folded inwardly so as to be folded over the terminal end of the arm 120 that is attached during externalization. When the arm 120 is under tension, the bulky central portion 1255 cannot be folded over itself from the terminal end of the arm 120, preventing the externalized anchor 125 from being pulled back through the wound. Thus, the central portion 1255, despite its large bulk, can be pulled through the wound in a first direction (outward from the eye), but its large bulk prevents it from being pulled through the wound in a second opposite direction (inward toward the eye).

[0069] The grippable portion 1257 can include any of a variety of shapes, such as an oval, rectangle, star pattern, or other shape or geometric form that improves the gripping of the grippable portion 1257 compared to, for example, the central portion 1255. The grippable portion 1257 may have thin and narrow tabs extending from the central portion 1255. Each anchor 125 may include one, two, three, four, five, six, or more grippable portions 1257 so that the user can grip the anchor regardless of the form of the device.

[0070] In some examples, each fixed arm 120 can have one or more anchors 125. FIG. 9 shows an example of a device 100 having three fixed arms 120, each having a first anchor 125a on the terminal side and a second anchor 125b located inside the first anchor 125a. The second anchor 125b can further fix the lens support structure 105 by preventing centrifugal slippage. Alternatively, the second anchor 125b can be externalized through the sclera 20 such that the second anchor 125b holds the device 100 in a predetermined position. In this situation, the surgeon has the option of trimming any material of the fixed arm 120 located around the second anchor 125b (e.g., the first anchor 125a). This multi-anchor system allows the surgeon to adjust the dimensions of the device 100 to fit the patient's eye during the surgery. Each fixed arm 120 can include a plurality of anchors 125 that can be arranged along the length of the fixed arm 120. The plurality of anchors 125 can include two, three, four, five, or more anchors 125 arranged at equal intervals along its length. Since the fixed arm 120 is externalized through the sclera, the length of the fixed arm 120 can also be "customized" according to the number of anchors 125 that are externalized. The surgeon can externalize the number of anchors 125 necessary to center the device 100. Excess material of the fixed arm 120 and the anchor 125 around the outermost anchor 125 closest to the sclera 20 can be removed, such as by trimming. FIG. 9 shows that the two anchors 125a, 125b have different outer dimensions and that the inner anchor 125b is narrower than the outermost anchor 125a. It should be understood that the plurality of anchors 125 can also have the same dimensions and do not necessarily need to be of different sizes. The anchor 125 can also have a shape that improves its passage through the sclera in a first direction but impairs its passage through the sclera in a second opposite direction. For example, FIG. 9 shows the square edges of the anchor 125. However, the anchor 125 can have square edges on the inner surface and smooth tapered edges on the outer surface that help it pass through the sclera in the outward direction.

[0071] The fixation arms 120 extending to the eye wall may be blocked from view by the peripheral iris 10, the limbus, and the sclera 20, and thus may be difficult to manipulate. As described above, one or more of the fixation arms of the fixation arms 120 are biased inwardly toward a folded configuration. Each of the fixation arms 120 initially extends orthogonally outward from the support structure 105 and then curves or folds forward (or backward) such that the end of the fixation arm 120 is positioned over at least a portion of the fixation arm 120, the support structure 105, or the central opening 115 extending through the support structure 105. At least a portion of the bent fixation arm (i.e., the end and / or the anchor 125) can be more readily visualized through the dilated pupil and the visualization is not obstructed by the opaque iris 10 (see FIG. 13). This inward (centripetal) bias also enables the bent fixation arm 120 to be safely grasped and manipulated during device implantation. Each of the fixation arms 120 of the device 100 can have an inward bias toward a folded configuration, or only a selection of the fixation arms 120 can have an inward bias (e.g., one, two, less than all of the fixation arms 120 at most).

[0072] Device 100 can be manufactured without inward biasing, and the inward biasing can be set using manual operation of the device. The operation can be performed by the manufacturer or by the surgeon. The purpose of the operation is to temporarily position at least a portion of the fixation arm 120 so that it can be easily visualized through the dilated pupil during implantation. This operation may include suturing two or more fixation arms 120 together. Once the surgeon is ready to manipulate the fixation arms 120 individually within the eye, the sutures are removable. The structure of device 100 can incorporate one or more features that allow the fixation arm 120 to be temporarily engaged with the lens support structure 105 to assist in visualization of the fixation arm 120. For example, FIG. 9 shows that the inner wall 109 defining the central opening 115 can include one or more notches 117 that can be used to temporarily hold the fixation arm 120 in an inwardly biased position. The shape of each notch 117 is complementary to the shape of the fixation arm 120 such that at least a portion of the fixation arm 120 can be received within the notch 117. The manufacturer or surgeon can fold, twist, or otherwise manipulate the fixation arm 120 into the notch 117. Following insertion into the eye, the surgeon can disengage the fixation arm 120 from the notch 117 and proceed to externalize the fixation arm 120 through the sclera. FIG. 9 shows that the notch 117 is on the inner diameter or inner wall 109. However, the notch 117 may be on another surface of the device 100, including the circumferential surface (e.g., outer wall 111), front surface, or back surface of the lens support structure 105.

[0073] The fixed arm 120 can also be shaped to incorporate a bend or curve between its origin with the lens support structure 105 and the terminal anchor 125 (see FIGS. 10 - 12, FIGS. 17B - 17E, FIG. 19A, FIG. 20A, FIGS. 21A - 21B, FIGS. 22A - 22B, FIGS. 23A - 23B, FIGS. 24A - 24F, FIGS. 25A - 25C, FIGS. 26A - 26E and FIG. 27). The bent fixed arm(s) 120 can be biased towards a folded configuration. For example, one or more of the fixed arms 120 can bend in the radial and centripetal directions between 90 degrees and 270 degrees from the origin of the lens support structure 105. Thus, the terminal of the bent fixed arm 120 is in a plane different from the plane of the lens support structure 105. When in the resting state before being placed in the eye, the terminal of at least the first fixed arm 120 of the plurality of fixed arms 120 can incorporate a bend between the origin of the lens support structure and its terminal that forms the bent arm. The bent arm can extend at least a first distance orthogonal to the lens support structure 105 from its origin. Thereafter, the bent arm can curve upward (forward) at least a different distance away from the plane of the lens support structure 105. Thereafter, the bent arm 120 can curve back towards its origin or towards the central axis CA of the device. This can result in a terminal of the bent arm 120 being in a plane different from the plane of the lens support structure 105. The curvature or bend of the arm 120 can project outwardly away from the central axis CA and away from both the origin 103 and the terminal 102 of the arm. The scleral anchor 125 and / or the terminal portion of the fixed arm 120 is disposed over or in front of at least a portion of the lens support structure 105 or over at least a portion of the central opening 115. Alternatively, the bent arm(s) 120 can curve downward (backward) at least a certain distance away from the plane of the lens support structure 105, and the scleral anchor 125 or the terminal portion of the fixed arm 120 can be positioned under or behind at least a portion of the lens support structure 105 and / or under or behind at least a portion of the central opening 115.The folding configuration (whether the arm 120 curves forward or backward) can enable at least a portion, such as the end of the bent fixed arm 120 and / or its anchor 125, to be visualized through the pupil and not be obstructed by the opaque iris. Only one of the fixed arms 120, two of the fixed arms 120, or all of the fixed arms 120 can incorporate the curvature.

[0074] When the device is placed and fixed inside the eye, the fixed arm 120 is under tension such that the bent arm unfolds away from this folding configuration and no longer bends. The end of the arm 120 pushes the bent fixed arm into a straight or unfolded configuration away from this stationary state where the arm 120 is in the folding configuration.

[0075] The bending of the folding configuration can be a gentle and smooth bend having a radius of curvature or can bend to form one or more distinct angles along the length of the arm 120. The bending can be relatively easily positioned in the deployed configuration without applying excessive stress to the lens support structure 105 and can be made tight enough so as not to protrude too far forward. The inwardly biased shape can have a curvature with a radius of curvature of the inner curve (the side facing forward) from about 0.10 mm to about 2.5 mm and a radius of curvature of the outer curve (the side facing rearward) from about 0.6 mm to about 3.0 mm. In an example, the end of the inwardly biased fixed arm can be spaced apart from the lens support structure 105 that forms a gap G (see FIG. 17B). The gap G can be from about 0.2 mm to about 2.5 mm. In an example, the biased fixed arm 120 is curved with a full radius of 180 degrees and has an inwardly biased geometric shape with a radius of curvature of about 0.63 mm for the inner curve and about 1.13 mm for the outer curve such that the lens support structure 105 and the biased fixed arm are spaced apart by about 1.25 mm. The starting point of the curve (with the lens support structure 105 near the starting point 103) and the ending point of the curve (near the end 102 of the scleral anchor 125) can have multiple radii such that the curve varies along the length of the fixed arm 120. The curve of the biased fixed arm 120 can have an average curvature between about 0.15 mm and about 2 mm for the inner curve.

[0076] After implantation and before securing to the scleral wall, the bent fixation arm 120 can be seen through the pupil when in a stress-free (rest) state (see FIG. 13). This visibility allows the surgeon to easily engage the anchor 125. When the surgeon engages the fixation arm 120 by gripping the body of the fixation arm 120 or the anchor 125, the surgeon can deploy the fixation arm 120 from the folded configuration by holding it stationary so that it is substantially on the plane with the lens support structure 105. These fixation arms 120 can have flexibility such that the stress stored in the material in the deployed state does not impart torsional or tensile forces to the lens support structure 105 that would compromise device function. The fixation arm(s) 120 can be shaped to have a swing of 90 degrees to 270 degrees in the tangential and centripetal directions from its lens support origin (see FIGS. 23A - 23B). The fixation arm(s) 120 can incorporate an elastic material or a deformable hinge to facilitate this operation without substantially changing the geometry of the lens support structure 105. The fixation arm 120 can have a length such that when the fixation arm 120 is bent 180 degrees towards the origin with the lens support structure 105, the end 102 of the fixation arm 120 is disposed on at least a portion of the lens support structure 105 as shown in FIGS. 10 - 11. Each of the fixation arms 120 of the device 100 can have a bend, or only a selected one of the fixation arms 120 can have a bend (e.g., one, two, less than all of the fixation arms 120). FIGS. 10 - 11 show that two of the fixation arms of the fixation arm 120 have a bend and one fixation arm is substantially in the same plane as the plane of the lens support structure 105.

[0077] One or more of the fixation arms 102 of the fixation arm 120 of the device described in this specification can be manufactured to have a non-planar shape in a stationary state, and can be biased towards a folded configuration that allows at least a portion of the fixation arm 120 to be easily viewed through the pupil before the device 100 is implanted but before the externalization of the anchor 125. The fixation arm 120 having this configuration can be more easily grasped and manipulated by the user so that it can be urged into a deployed configuration for sutureless fixation. The fixation arm 120 manufactured to have a bias in a stationary state, or the fixation arm 120 that is curved or bent in a stationary state, includes the fixation arm 120 having its shape when the device 100 is outside the eye and ready for implantation. In some examples, the fixation arm 120 can take a curved, folded, or bent shape after being implanted into the eye (e.g., the posterior chamber) but before the anchor is fixed. For example, one or more of the fixation arms 120 can be made of a material that has a first shape outside the eye, takes a curved shape different from the shape of the arm 120 during implantation into the eye during implantation, and can be deployed into a substantially straight shape during the externalization of the anchor 125.

[0078] The fixed arm 120, which has a bias to a folded shape or a curved shape (e.g., having a bend along its length between its starting portion 103 and its end 102), can be visualized, grasped, and manually deployed and / or extended through the pupil in order to firmly fix the anchor 125 of the arm 120. At least a portion of the fixed arm 120 (e.g., the anchor 125 and / or the end portion coupled to the anchor 125) can vary in terms of its configuration of curvature, bend, or fold and / or radius of curvature, and the directionality of the curvature, bend, or fold, as long as at least a portion of the fixed arm 120 is visible to the user through the diameter of the patient's pupil, preferably the dilated pupil of the patient. In some examples, this means that at least a portion of the fixed arm 120 is on at least a portion of the lens support structure 105 and is located radially inside its outer wall 111. The distance by which the relevant portion of the arm 120 extends radially inside the outer wall 111 can vary. The relevant portion can extend such that it is above a certain position adjacent to the outer wall 111 and not on the outer wall 111 in the direction of the central axis CA extending from the front to the rear through the central opening 115. In this example, the distance from the central axis CA of the device to the relevant portion extending upward is greater than the distance from the central axis CA of the device to the outer wall 111. The relevant portion can extend such that it is on the outer wall 111. In this example, the distance between the central axis CA of the device and the relevant portion is the same as the distance between the central axis CA of the device and the outer wall 111. The relevant portion can extend such that it is in a position radially inside the outer wall 111. In this example, the distance between the central axis CA of the device and the relevant portion is less than the distance between the central axis CA of the device and the outer wall 111. The relevant portion can extend such that it is above the central opening 115. In this example, the distance between the central axis CA of the device and the relevant portion is shorter than the distance between the central axis CA of the device and the inner wall 109 defining the central opening 115.

[0079] A portion of the fixed arm (e.g., the terminal and / or the anchor 125) can be positioned over a portion of the lens support structure 105 and at the same time over a portion of the central opening 115. For example, the anchor 125 can have dimensions such that at least a portion of the anchor 125 is positioned over at least a portion of the lens support structure 105 and another portion of the anchor 125 is positioned over at least a portion of the central opening 115.

[0080] The fixed arm 120 biased towards a curved configuration can curve towards the inner or central portion of the device, including but not limited to the actual center or central axis CA of the device. The center of the device 100 is the center of the circle formed by the central opening 115 (in the example where the central opening 115 is circular). The central axis CA of the device extends in the front-rear direction (i.e., the up-down direction) through the center of that circle. When the central opening 115 is substantially non-circular, the center of the device is the center of symmetry of the central opening 115 along the central axis CA extending in the front-rear direction. A fixed arm biased towards a folded or curved configuration such that its anchor extends towards the center of the device or towards the central axis CA of the device does not require the axis passing through the anchor of the arm to intersect the actual center or the central axis CA of the device. "Towards the center" or "towards the central axis" with respect to an inwardly biased fixed arm includes an arm having a curvature such that the end of the fixed arm extends back towards a portion of the device in a substantially inward direction, as opposed to the end of a straight fixed arm extending in a substantially outer direction away from the lens support structure. The curved fixed arm can be biased towards any central portion of the device and does not need to be directly facing the actual center of the device. The curved fixed arm can be angled with respect to the actual center.

[0081] Figures 22A - 22B and 23A - 23B are diagrams showing examples of a device in which at least a portion of a fixed arm extends rearward toward the center of the device. Figure 22A shows a device 100 having a lens support structure 105 and three fixed arms 120. Two of the fixed arms 120a, 120b are biased toward a folded configuration where a bend B exists between the starting point 103 and the ending point 102 of the arm. The third fixed arm 120c is substantially straight, has no bend B between its starting point 103 and ending point 102, and extends substantially perpendicular to the lens support structure 105 along one axis. The anchors 125 of each of the fixed arms 120a, 120b project rearward toward the center of the device. The anchors 125 of the fixed arms 120a, 120b have at least a first portion that overlaps at least a portion of the lens support structure 105 and / or at least a second portion that overlaps at least a portion of the central opening 115 (see Figure 22A). Through the anchor 125 of each arm 120a, 120b, an axis can be drawn that illustrates the direction in which the anchor projects away from the bend B between the starting point 103 and the ending point 102 of the arm and toward the center of the device. Axis LI and axis L2 do not intersect the central axis CA. Figure 22B shows a similar device 100 having two fixed arms 120a, 120b that are biased toward a folded configuration. Each has a bend B between the starting point 103 and the ending point 102 of the fixed arms 120a, 120b. The anchors 125 of each of the fixed arms 120a, 120b extend rearward toward the center of the device. Axis L1 and axis L2 intersect the central axis CA. Thus, the arms are biased toward a folded configuration where the anchors project toward the center of the device, but do not necessarily extend along an axis that intersects the central axis CA or the actual center of the device.

[0082] When the fixed arm is described as "folded" or "bent" or "curved", or as having a "folded" or "bent" or "curved configuration, the angle of the fixed arm relative to the longitudinal axis along its length can vary gradually and uniformly or can change more abruptly or suddenly such that an angle is formed. The folding configuration can account for the inward biasing of the fixed arm at the time of installation or at the beginning of implantation, where the fixed arm extends outward from the support structure along a first axis and curves forward or backward relative to the plane of the support structure that returns toward the central portion of the device. The support structure of the device when implanted is configured to be substantially parallel to the Z-plane (vertical plane) of the eye. The folding configuration can include a shape in which the fixed arm curves away from this plane of the support structure, as shown in FIGS. 22A-22B (e.g., within a cross-section). As a result, at least a portion of the fixed arm is positioned in front of another portion of the device (e.g., itself, the lens support structure, and / or over the central opening). The folding configuration does not necessarily mean that the fixed arm portions overlap and are in contact with each other. Preferably, the portions of the fixed arm are positioned at a distance from each other, and that distance is along the central axis CA of the device. Also, the folding configuration does not necessarily mean that there are creases or sharp folds. The folding configuration can be meant to have a radius of curvature present between the origin and the terminus of the fixed arm in the support structure.

[0083] The folding configuration can also include a fixed arm that curves within the plane of the lens support structure rather than away from the plane of the lens support structure. FIGS. 23A-23B illustrate another example of a device 100 having a lens support structure 105 and three fixed arms 120. Two of the fixed arms 120a, 120b are biased into a folding configuration where a bend B exists between the starting point 103 and the ending point 102 of the arm. The third fixed arm 120c is substantially straight and extends substantially perpendicular to the lens support structure 105 along an axis and has no bend B between its starting point 103 and its ending point 102. The anchor 125 of the straight fixed arm 120c projects outwardly away from the center of the device along the axis of the fixed arm. In contrast, the anchors 125 of each of the fixed arms 120a, 120b project inwardly from the bend B of the fixed arm. The anchors 125 remain within a plane substantially the same as the plane of the lens support structure (see FIG. 23B). An axis can be drawn through the anchor 125 of each of the bent fixed arms 120a, 120b that indicates the direction in which the anchor 125 projects away from the bend B between the starting point 103 and the ending point 102 of the fixed arm and toward the center of the device. The fixed arms 120a, 120b biased into the folding configuration have an anchor 125 that projects toward the center of the device. The axes LI, L2 may intersect the central axis CA but do not have to. The axis LI and the axis L2 shown in FIG. 23A extend toward the center but do not intersect the central axis CA.

[0084] A portion of the fixed arm 120 positioned on at least a portion of the support structure 105 can include that the portion is on the outer wall 111 of the support structure 105 and is positioned radially inward. A portion of the fixed arm 120 positioned on at least a portion of the support structure 105 can include that the portion is positioned radially inward of the central opening 115 and is positioned above the central opening 115. In this case, "radially inward" does not necessarily mean being in the same plane. Preferably, a portion of the fixed arm 120 is positioned on a portion of the support structure in a plane different from the plane of the support structure. A portion of the fixed arm 120 (e.g., the anchor 125 and / or the termination 102) can terminate in front of or behind the lens support structure 105 at a diameter that is the center of the outer periphery of the lens support structure 105. The portion can be positioned on a portion of the lens support structure with respect to the central axis CA of the device extending from front to back through the central opening 115. When a portion of the fixed arm 120 is described as being on a portion of the lens support structure, the portion of the fixed arm 120 can be above the central opening 115 defined by the lens support structure 105.

[0085] In this specification, when a portion of the fixed arm 120 is described as being "above" another portion of the device 100 (e.g., itself, the lens support structure 105, and / or the central aperture 115), the portion of the fixed arm 120 generally can overlap that portion of the device in space, so there is no need to require a specific orientation with respect to the retina. Thus, "above" can be used in this specification to refer to an overlap in the space surrounding the device, and while the spatial overlap can be required to be generally forward with respect to the retina, it need not be. A portion described as being "above" another portion can, in use, be located behind that portion with respect to the retina. The fixed arm 120 biased into a folded configuration can, in use, be located "below" or "behind" another portion of the device with respect to the retina, yet in this specification may only be referred to as being "above" or "overlapping" another portion of the device. For simplicity, each alternative may not be repeated in each example throughout this disclosure. The fixed arm can be curved such that at least a portion of the fixed arm is positioned over a portion facing the front of the device such that the portion is generally arched above the device along the central axis CA. The fixed arm can be curved such that at least a portion of the fixed arm is positioned over a portion facing the rear of the device such that the portion is generally arched below the device along the central axis CA. The fixed arm can be curved such that at least a portion of the fixed arm is positioned in the same plane, such that the portion does not exist over a portion facing the front of the device or over a portion facing the rear of the device. In this specification, any of various configurations of the fixed arm are contemplated such that at least a portion of the fixed arm is visible through the dilated pupil. The mechanism by which the bent fixed arm 120 biased towards a folded configuration unfolds into a straight configuration can be varied. The fixed arm can unfold mechanically, electromagnetically, and / or thermally.

[0086] In some examples, the fixed arm 120 may be mechanically deployed along one axis of the fixed arm. The fixed arm 120 at the time of installation does not need to be biased into a folded configuration having a bend or a curve. For example, the fixed arm 120 may be biased into a folded configuration in which the fixed arm 120 is longitudinally compressed along one axis. The fixed arm 120 extends outwardly at a right angle from the lens support structure along one axis between its starting portion 103 and its end portion 102. The length of the fixed arm 120 in the folded configuration can be made shorter between the starting portion 103 and the end portion 102 so that the anchor 125 of the fixed arm 120 is positioned more centrally within a smaller diameter than in the deployed configuration. Before the device is implanted in the eye but before the externalization of the anchor 125, the fixed arm 120 may be telescoped outward to extend its length so that it can be externalized. The mechanical deployment by telescoping can also be due to nested parts of the fixed arm 120 that slide relative to each other to provide a long dimension when deployed and a short dimension when folded. The mechanical deployment by telescoping can also be due to one elastic part configured to be folded in on itself in a short dimension for visualization through the pupil and to deploy away from itself in a long dimension upon externalization.

[0087] In some examples, the fixed arm 120 may be thermally deployed or folded. For example, the fixed arm 120 can be in a first shape (folded or straight state) at room temperature and change to a second shape at body temperature or a temperature in the vicinity thereof (a state heated to 35°C). This can also be achieved by chemical means (e.g., hydration) or mechanical means (cutting of a limiting function).

[0088] The fixation arm 120 can be manufactured from an elastic or non-elastic material. For example, the fixation arm 120 can be formed from a non-elastic material and have a three-dimensional shape that provides elasticity. The three-dimensional shape can vary to include a C-shape, Z-shape, S-shape, or other three-dimensional shapes as described elsewhere in this specification. The fixation arm 120 provides sufficient support to maintain the intraocular lens 110 or other device while not exerting excessive force on the sclera. The optimal design will have a wide range of operable tension and stability such that both parameters can be met for eyes of various sizes and incisions at various locations. One means of changing the design of the fixation arm is to incorporate a spring-like structure. These include conventional compression-based haptic designs such as J-loops, C-loops, closed loops, Kellman Haptics, plate haptics, or other haptic designs common to intraocular lenses. Alternatively, the device 100 can incorporate a tension-based haptic such as a simple linear elastic cord. Alternatively, the tension design can be modified with V-shaped, Z-shaped, or S-shaped features to reduce the tensile resistance of the fixation arm 120.

[0089] The fixation arm 120 can have a texture or feature that allows it to be pulled in one direction through the sclera but is resistant in the opposite direction, minimizing the possibility of the fixation arm 120 slipping. The texture or feature can be provided by the material itself or configured on the fixation arm 120. For example, the fixation arm 120 can be formed from a barbed material integrated with an external structure. In this way, an internal structure with barbs can function as a barb while hiding the sharp edges commonly associated with barbs. For example, in the case where a hard plastic structure is embedded within a soft elastomeric structure.

[0090] The fixed arm 120 can be formed of a flexible material that has a restoring force (memory) and is not malleable. The flexible material of the fixed arm 120 can include any of various elastomers including polyurethane, hydrophobic acrylic, hydrophilic acrylic, nylon, polyimide, PVDF, natural polyisoprene, cis-1,4-polyisoprene natural rubber (NR), trans-1,4-polyisoprene gutta percha, synthetic polyisoprene (IR of isoprene rubber), polybutadiene (BR of butadiene rubber), chloroprene rubber (CR), polychloroprene, neoprene, biprene, etc., butyl rubber (copolymer of isobutylene and isoprene, IIR), halogenated butyl rubber (chlorobutyl rubber: CIIR, bromobutyl rubber: BIIR), styrene butadiene rubber (copolymer of styrene and butadiene, SBR), nitrile rubber (copolymer of butadiene and acrylonitrile, NBR), hydrogenated nitrile rubber (HNBR) also called buna-N rubber, terban and zetpol, EPM (ethylene propylene rubber, copolymer of ethylene and propylene) and EPDM rubber (ethylene propylene diene rubber, terpolymer of ethylene, propylene and diene component), epichlorohydrin rubber (ECO), polyacrylic rubber (ACM, ABR), silicone rubber (SI, Q, VMQ), fluorosilicone rubber (FVMQ), fluoroelastomer (FKM, and FEPM) viton, teflon, fluorel, aflas, diel, perfluoroelastomer (FFKM) teflon PFR, calrez, chemraz, perlast, polyether block amide (PEBA), chlorosulfonated polyethylene (CSM), (hypalon), ethylene vinyl acetate (EVA), thermoplastic resin elastomer (TPE), resilin and elastin, polysulfide rubber, elastolefum.

[0091] The fixed arm 120 made of a flexible material formed in a certain shape can bend away from the formed shape but has a memory to return to the formed shape. In other words, the flexible fixed arm 120 can bend or unfold away from its folded configuration but cannot be urged into another shape that is retained without some anchor fixation. For example, one or more of the flexible fixed arms 120 can be formed in a bent shape. For example, the fixed arm can include a 180-degree bend from a starting point 103 with the support structure 105 to an end point 102 near the anchor 125. The fixed arm 120 can maintain this bent shape when the device is stationary and no force is applied to the fixed arm 120 such that the fixed arm 120 is biased towards the folded configuration. In other words, the fixed arm 120 in the unbiased state is bent. The bent fixed arm 120 can bend away from this bent shape and take on a straight shape or a deployed configuration such that the entire fixed arm 120 extends straight and is positioned with respect to the longitudinal axis L. When the fixed arm 120 bends into a straight shape, the fixed arm 120 is biased to return to the bent shape or the folded configuration. If the bending force on the fixed arm 120 is released, the fixed arm 120 returns to its resting bent shape. However, in use, the fixed arm 120 is firmly fixed, and the anchor 125 at the end 102 of the fixed arm 120 is located outside the dura mater. The fixed arm 120 is under tension to maintain a straight shape.

[0092] In other examples, the fixed arm 120 can be formed of or incorporate a material that is malleable such that the fixed arm 120 bends or is formed into a particular shape. The malleable fixed arm 120 can be formed of materials such as implant-grade metals or plastics including gold, silver, platinum, stainless steel, nitinol, nickel, titanium, polypropylene, polyethylene, nylon, PVDF, polyimide, acetal, and PEEK.

[0093] One or more fixed arms 120 can 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 fixed arms 120 can have a Young's modulus of less than about 20 MPA, for example, from about 0.01 to about 1.0 MPA. The fixed arm 120 is configured to have a tension for fixing the support structure 105, rather than a spring force for fixing the support structure 105 or a more rigid through force that can provide a catch or other fixed haptic, so it is very soft and can apply a very small force.

[0094] In some examples, each of the fixed arms 120 can have a length between the starting point 103 and the end point 102 that is from about 2 mm to about 6 mm. Each of the fixed arms 120 can have the same length. The length of the fixed arm 120 extending through the strong film can have a thickness or width that is minimized to reduce the overall size of the wound through which the fixed arm 120 extends. The maximum width of the strong film portion of the fixed arm near the end point 102 where the anchor 125 is located can be made to be about 2.0 mm or less, about 1.5 mm or less, about 1.0 mm or less, 0.75 mm or less, 0.50 mm or less.

[0095] FIG. 12 shows an example of a device 100 having two fixed arms 120a, 120b with an inward bias and a third fixed arm 120c that has no inward bias and is straight. Further, the third fixed arm 120c has a less flexible shape than the other fixed arms 120a, 120b. The third fixed arm 120c can incorporate a certain region between a starting point 103 and an end point 102 that is wider than the other two fixed arms 120a, 120b and can have a larger cross-sectional area. FIG. 8B shows a certain region of the wider fixed arm 120. The width W1 of the fixed arm 120 near the end point 102 can be smaller than the width W2 of the fixed arm 120 away from the end point 102 of the fixed arm 120. The width W2 of the fixed arm 120 away from the end point 102 can provide a certain amount of bulk and stability, while the width W1 near the end point 102 can minimize the reinforced film portion of the fixed arm 120.

[0096] Each of the fixed arms 120a, 120b, 120c can be positioned one at a time during a surgical procedure. As described elsewhere in this specification, the leading fixed arm 120c can be straight-shaped, and the trailing fixed arms 120a, 120b can be curved (see FIGS. 17A - 17D). The weight of the device can cause the first implanted or leading fixed arm 120c to bend following externalization such that the device 100 tilts backward toward the retina. In this scenario, the surgeon can position the device in a more posterior location. However, this may increase the risk of intraoperative tissue damage due to manipulation of tools near the retina. In some examples, the leading fixed arm 120c can be mechanically and / or geometrically reinforced to reduce the potential for posterior displacement. The leading fixed arm 120c can be manufactured from a material that can withstand such deformation. The material can be any implant-grade plastic or metal that can cantilever the device following externalization of the anchor 125 of the leading fixed arm 120c. Suitable materials include, but are not limited to, PMMA, rigid silicone, nylon, hydrophilic and hydrophobic acrylics, PEEK, polyimide, stainless steel, titanium, nitinol, etc. A more rigid material can be used to form the entire leading fixed arm 120c or only a portion of the leading fixed arm 120c. The leading fixed arm 120c may be formed of a more flexible material with a more rigid material embedded therein. In an example, the leading fixed arm 120c can include a region 1205 of mechanical reinforcement between its origin 103 in the support structure 105 and its terminus 102 coupled to the anchor 125 (see FIG. 17A). The region 1205 can be achieved by increasing the thickness of the fixed arm 120c or embedding a rigid portion of plastic into a more flexible material. FIG. 17A shows an increase in thickness (arrow T) in the region 1205 of mechanical reinforcement compared to the thickness (arrow O) of the fixed arm near the origin 103 with the support structure. The region 1205 can be positioned at a distance from the support structure 105, for example, near or adjacent to the anchor 125.Region 1205 can have an increased thickness (see FIGS. 17A - 17D) configured to specifically reduce the likelihood of the device 100 drifting backward while not affecting the ability to externalize the anchor 125 of the fixed arm 120. For example, the fixed arm 120 can have a tapered thickness configured to limit rearward deflection. The tapered shape can be thinnest near the footplate anchor 125 and thicker at the center. The rear surface of the fixture can serve to bias the device forward with respect to the eye. The contact angle between the rear surface of the fixed arm 120 and the sclera can bias the device 100 in a way that reduces the actual risk of rearward deflection of the fixed arm 120. Additional bulk can further limit the device's deflection and proximity to the retina.

[0097] The transscleral fixed arm 120 and / or anchor 125 can have photo - reactive or water - reactive elements that assist in sizing or securing the fixed arm. To adjust the length of the fixed arm during or after surgery, the shape of the fixed arm can be expanded or contracted by expanding or contracting a portion of the fixed arm. Alternatively, by expanding the anchor following externalization of the fixed arm, the anchor becomes more effective in providing secure fixation with reduced risk of slippage.

[0098] The cross - anchor of the fixed arm can slide along the fixed arm 120 with some resistance. By adjusting the fixed arm 120 during surgery, the surgeon can specify the size of the device 100 for a given patient. The custom size reduces the risk of effective lens position deviation and modulation. When the fixed arm 120 is set to the appropriate tension, excess material can be removed, such as by trimming.

[0099] Device 100 can function as a drug delivery device that includes a refillable drug delivery device and can be made of a material or can include a geometric shape. A securely fixed device that provides access to the subconjunctival space provides an opportunity to deliver drugs to the posterior and anterior segments of the eye. Examples of therapeutic agents can include one or more ocular hypotensive agents (glaucoma therapeutic agents), steroids, anti-vascular endothelial growth factor (anti-VEGF), gene therapy agents, antibacterial agents, antiviral agents, chemotherapeutic agents, biological agents such as non-steroidal anti-inflammatory agents, for treating eye or systemic diseases.

[0100] Device 100 can include a structure to which the haptic 114 of an intraocular lens is fixed. In some situations, the haptics 114 of the intraocular lens are fixed within a groove. However, it may be advantageous to provide a location for haptic fixation within the device itself. The structure of device 100 can be one or more pockets on the inner wall 109 of a lens support structure 105 that is dimensioned and shaped to receive the haptics 114 of the intraocular lens. Alternatively, the front or rear surface of device 100 can include slots or fasteners that can receive the haptic 114 of the intraocular lens and fix it in place. The lens support structure 105 can have one or more holes through which the haptic 114 of the intraocular lens can pass. Or, the haptic shape can be configured such that the haptic 114 of the intraocular lens is wrapped around one or more of the fixing arms 120. The fixing arms 120 can have holes through which the haptic 114 of the intraocular lens can pass.

[0101] Device 100 may be configured to host an intraocular lens 110 of any form having any haptics design and any optics design. Device 100 may be configured to conform to a particular intraocular lens design having a shape specially configured to mate with a lens support structure 105. The design may be particularly suitable for enabling lens exchange. The lens support structure 105 may be manufactured with an integral lens 110 that provides refractive correction. The correction may include, but is not limited to, the optics of a monofocal, extended depth of focus, accommodative, light-adjustable, multi-piece / swappable, or multifocal intraocular lens.

[0102] The devices described in this specification can be used with intraocular lenses having any of a variety of conventional designs, including multi-piece designs and one-piece designs. The intraocular lens 110 has a central optical portion 112 and two haptics 114 (see, for example, FIGS. 19B-19C, FIGS. 20B-20C, FIG. 24B, FIG. 24C, FIG. 24F, FIG. 25B, FIG. 25C, FIG. 26B, FIG. 26C, and FIG. 26E). The haptics 114 can be conventional open-loop haptics such as C-loops, J-loops, modified J-loops, etc. The intraocular lens 110 may be positioned above (or below) the central opening 115 of the device such that a central axis CA extending in the anterior-posterior direction through the central opening 115 extends through the optical portion 112 of the intraocular lens 110. The haptic 114 of the intraocular lens 110 may project upwardly or forwardly away from the lens support structure 105 (or, if positioned below, toward the lens support structure 105), as described elsewhere in this specification. A one-piece intraocular lens can have open-loop haptics, similar to a conventional three-piece intraocular lens. A one-piece intraocular lens can also incorporate a monoblock plate-style haptic. If the device is shown with one type of intraocular lens (e.g., the multi-piece intraocular lens shown in FIGS. 19B-19C and FIGS. 20B-20C or the one-piece intraocular lens shown in FIGS. 24B, FIG. 24C, FIG. 24F, FIG. 25B, FIG. 25C, FIG. 26B, FIG. 26C, and FIG. 26E), it should be understood that another type of intraocular lens can be fitted with the device. The devices described in this specification can be used with any type of intraocular lens as described elsewhere in this specification, including multi-piece designs and one-piece designs. Similarly, the haptics of the intraocular lens can be of any of a variety of configurations.

[0103] The lens support structure 105 can have a shape configured to fit around the intraocular lens and / or with one or more haptics of the intraocular lens. The shape can include recesses, depressions, channels, or grooves that form at least a portion of the inner perimeter of the lens support structure.

[0104] Figures 24A - 24F, 25A - 25C, and 26A - 26E illustrate various examples of devices configured to mate with an intraocular lens such that at least a portion of the intraocular lens is covered by at least a portion of the inner surface of the device.

[0105] Figures 24A - 24F illustrate an example of a device 2100 having a lens support structure 2105, a central opening 2115, and a plurality of fixing arms 2120. The central opening 2115 is bounded by the inner circumference or inner wall 2109 of the lens support structure 2105. The central opening 2115 can be circular, while the outer circumference or outer wall 2111 of the lens support structure 2105 can be non - circular. As described elsewhere in this specification, the outer circumference of the lens support structure 2105 can have any of a variety of shapes including circular, non - circular, oval, elliptical, rounded rectangle (Figs. 25A - 25C), rounded triangle (Figs. 26A - 26E). The lens support structure 2105 can support the intraocular lens 110, for example, instead of the native capsular bag of the crystalline lens. The device 2100 can include one or more leaflets or awnings 2126 located on the front - facing surface of the lens support structure 2105, resulting in the formation of one or more recesses 2104 in which at least a portion of the intraocular lens 110 is located. The recesses 2104 can at least partially surround the central opening 2115 and be dimensioned to accommodate at least a portion of the intraocular lens, such as the haptics 114. Figs. 24B, 24C, and 24F show the intraocular lens 110 engaged with the device 2100. The optical portion 112 of the intraocular lens 110 is located above the central opening 2115, and the peripheral region of the rear - facing surface of the optical portion 112 is positioned relative to the front - facing surface of the lens support structure 2105. Each of the haptics 114 of the intraocular lens 110 can be positioned substantially within its respective recess 2104, and most of the optical portion 112 of the intraocular lens 110 remains outside the recess 2104. The recesses 2104 are defined by the front - facing surface of the lens support structure 2105 and the projecting leaflets or awnings 2126. The volume of the recesses 2104 formed by the space between the front - facing surface of the lens support structure 2105 and the rear - facing surface of the awnings 2126 is sufficient to receive each one of the haptics of the intraocular lens 114 in terms of both the front - to - rear depth and the distance from the central axis CA of the opening 2115.The o-ring 2126 can have a smooth shape and, when disposed on the device 2100, can serve to protect the iris from any sharp edges of the intraocular lens. Further, the central facing surface of the o-ring 2126 (facing the central axis CA of the device 2100) can further serve to provide a surface against which the haptics 114 abuts. These surfaces can provide counter-pressure to the haptics, thereby assisting in centering the intraocular lens 110 on the device 2100. The o-ring 2126 can serve to limit the Z-axis movement of the haptics 114 and help to fix the intraocular lens 110 to the device 2100. The secure fixation of the intraocular lens, including a one-piece intraocular lens, enables the use of intraocular lenses that require strict centering tolerances (e.g., toric, multifocal lenses, extended depth of focus (EDOF) intraocular lenses, accommodating intraocular lenses).

[0106] The intraocular lens 110 may be positioned within the device 2100 either before or after implantation in the eye. Similarly, the intraocular lens 110 may be removed from the device 2100 and replaced postoperatively.

[0107] Figures 24A - 24F are diagrams showing an example of the device 2100 having a substantially elliptical outer periphery 2111 with a major axis and a minor axis. Thus, the inner periphery 2109 may define a circular central opening 2115 and the outer periphery 2111 may define a non-circular shape. The recesses 2104 formed by the o-ring 2126 are located on opposite sides of the major axis such that the span of the haptics 114 of the intraocular lens 110 is received within the recesses 2104.

[0108] Figures 25A - 25C illustrate another example of a device 2100 having a circular central opening 2115 and a non - circular outer periphery 2111. The non - circular outer periphery 2111 of Figures 25A - 25C is a rounded rectangle having two substantially flat and elongate sides 2108 and two substantially rounded short sides or lobes 2107. The recesses 2104 formed by the openings 2126 are located generally opposite each other along the major axis of the rectangle and may project above the front - facing surface of the lens support structure 2105 so as to be spaced apart to accommodate the span of the haptics 114 of the intraocular lens 110. For example, the openings 2126 may project above the front - facing surface of the lens support structure 2105 at the short sides of the rounded rectangle (i.e., at the location of the lobes 2107) along the long sides 2108 to accommodate the span of the intraocular lens therebetween within the recesses 2104.

[0109] Three fixation arms 2120 are coupled to the lens support structure 2105. At least one of the fixation arms 2120a, 2120b is biased into a folded configuration as described elsewhere in this specification. One fixation arm 2120c can be a leading fixation arm that extends along one axis orthogonal to the lens support structure 2105 such that the terminal 2102 of it coupled to the anchor 2125 projects outwardly away from the central axis CA of the central opening 2115. The leading fixation arm 2120c can be coupled to the lens support structure 2105 at the location of the lobe 2107, and the other fixation arms 2120a, 2120b can be coupled to the opposite side 2108 at a location away from the lobe 2107 of the leading fixation arm such that the opposite lobe 2107 projects outwardly between the fixation arms 2120a, 2120b (see Figures 25A - 25B).

[0110] Figures 26A - 26E illustrate another example of a device 2100 having a circular central opening 2115 and a non - circular outer periphery 2111. The non - circular shape of the outer periphery 2111 may be a rounded triangular shape having a plurality of lobes 2107 protruding outward from a plurality of sides 2108, as described elsewhere in this specification. Each of the three fixing arms 2120 may extend outward from one of each of the plurality of sides 2108. The openings 2126 may protrude onto the front facing surface of the lens support structure 2105 such that they are located on substantially opposite sides of each other. The first opening 2126 may be located, for example, on a side 2108 near the origin 2103 of the leading fixing arm 2120c, and the second opening 2126 may be located on a lobe 2107 between the other two fixing arms 2120a, 2120b (see FIGS. 26A - 26B). The arrangement of the openings 2126 relative to each other can be rotated such that the first opening 2126 is located on a lobe 2107 adjacent to the origin 2103 of the leading fixing arm 2120c and the second opening 2126 is located on a side 2108 near the origin 2103 of one of the curved fixing arms 2120a, 2102B. Regardless of the direction, the span of the recess 2104 defined by the openings 2126 and the lens support structure 2105 is sufficient to accommodate the span of the haptics 114 of the intraocular lens therebetween (see FIG. 26C).

[0111] The central opening 2115 may have a diameter as described elsewhere in this specification such that the optical portion 112 of the intraocular lens is supported on the front facing surface of the lens support structure 2105 without passing through its diameter (e.g., between about 4 mm and about 6 mm). The intraocular lens may be inserted into the recess 2104 below the orifice 2126. Thus, the diameter between the opposing first orifice 2126 and second orifice 2126 is sufficient for intraocular lens insertion. Since the intraocular lens is generally foldable, the diameter between the first orifice 2126 and the second orifice 2126 can vary widely. In some examples, the opposing orifices 2126 are completely connected to each other along the side 2108 (see FIG. 24C). The opposing orifices 2126 can include extensions along each of the sides 2108 that form a surface that completely overhangs the lens support structure 2105 defining the upper opening 2127. The upper opening 2127 can have a diameter larger than the diameter of the central opening 2115 of the lens support structure 2105. For example, the upper opening 2127 can be larger than about 6 mm so that the intraocular lens can be manipulated into place and fully expanded into the location of the recess 2104. The diameter of the upper opening 2127 can be greater than 6 mm and up to about 8 mm.

[0112] FIG. 27 shows related examples of device 2100 having an opening 2126 with a plurality of bumpers 2119 further incorporated to assist in centering device 2100 within the eye. Device 2100 can include four bumpers 2119 that project outwardly from each corner of lens support structure 2105. Bumpers 2119 may be substantially ring-shaped or may be an incomplete ring having a C-shape. The ring-shaped bumpers 2119 can include a first end and a second end that are both coupled to lens support structure 2105. The C-shaped bumpers 2119 can have one end coupled to lens support structure 2105 and a second end that remains separated from lens support structure 2105. Regardless of shape or configuration, bumpers 2119 can keep device 2100 away from adjacent eye tissue. In some examples, bumpers 2119 can be slightly deformable when contacting the ciliary structure. The deformation can be temporary such that the bumper returns to its original shape and pushes device 2100 back toward the central position within the eye. Similar to other examples described in this specification, device 2100 can include a plurality of fixed arms 2120 that include at least one biased into a folded configuration. Preferably, bumpers 2119 avoid remaining in contact with the ciliary structure when device 2100 is implanted. Bumpers 2119 can function as a guide during the externalization of fixed arms 2120. Bumpers 2119 project sufficiently away from outer perimeter 2111 of lens support structure 2105 to prevent displacement in the Z-plane in contact with the ciliary body 15 and / or within ciliary sulcus 25 and can maintain an appropriate placement between central opening 2115 and the visual axis of the eye during fixation.

[0113] A needle or guide wire (with or without suture) can be formed into the end foot plate or anchor 125 such that the fixed arm 120 is externalized from the eye. Optionally, the needle or guide wire can be externalized at an exact position prior to inserting the body of the device 100 into the eye. Once the surgeon is satisfied with the position of the needle or guide wire, the device 100 is inserted into the eye and each fixed arm 120 is secured in place in a proper procedure to ensure centering and Z-axis positioning. Once the device 100 is properly secured, the surgeon can cut the suture and / or needle from the device 100 leaving the anchor 125 in place. Alternatively, an improved sharp forceps / handle at the tip can be inserted through the main corneal incision (used for insertion of the lens fixation device) and then used to engage the fixed arm 120 and be externalized. This allows both the creation of the sclerotomy and the externalization of the anchor 125 of the fixed arm to be performed in one pass.

[0114] The device 100 can be inserted through a corneal or scleral incision using forceps or other common ophthalmic instruments. Alternatively, the device 100 can be inserted using an injector system similar to an intraocular lens injector. The injector allows the device 100 to be expanded such that the fixed arms 120 are sequentially presented to the surgeon. As an alternative, the injector can present the full device 100 within the anterior or posterior chamber in a configuration that limits the risk of surgical error. For example, the injector can ensure that the device 100 is inserted "in the correct orientation." Further, the injector can limit the risk of damage to the iris 10, endothelium, capsule, or zonules during implantation.

[0115] The device 100 described herein provides a stable platform and serves as an artificial anterior portion of the capsular bag for placement of the intraocular lens 110. Reliable centering and axial location of the lens support structure 105 is important for optimal operation of the device 100. In some instances, a guide system can be used to align the sclerotomy site. The guide system can employ features similar to intraoperative toric markers and preoperative toric bubble markers. In addition to marking the correct meridional location, the markers aid in alignment of the incision relative to the limbus. Acceptable locations for the sclerotomy include posterior to the limbus and anterior to the serra. In the human eye, the sclerotomy can be placed about 0.1 mm to about 4 mm posterior to the limbus. By varying the anterior / posterior sclerotomy site relative to the limbus between about 0.1 mm to about 4 mm (Z-axis) or about 1.5 mm to about 4 mm, the tension of the fixation arms can be controlled within an acceptable range. By varying the diameter of the marker / device pair, the optimal size and position of the device 100 can be determined with the guide / marking system. FIGS. 14A-14B and 15A-15I show an exemplary sclerotomy guide tool 1000 incorporating multiple marking features 1005 used to assist in identifying and marking a sclerotomy site for inserting the fixation arms 120 of the device 100. The tool 1000 may incorporate three marking features 1005 protruding from a distal end region 1015 of the handle 1010. The handle 1010 can extend along a first axis A, and the distal end region 1015 can be angled away from the first axis A. The distal end region 1015 of the tool 1000 can form a tripod 1020 having a feature 1005 protruding from each prong 1025 of the tripod 1020 (see FIG. 14A). The distal end region 1015 of the tool 1000 can include a ring 1030 with marking features 1005 protruding from a distal facing surface of the ring 1030 (see FIG. 14B). The ring 1030 can provide a centering function. The surgeon can use the limbus, pupil, and white-white as references. The marking features 1005 can create at least three contact points to define the location of the sclerotomy.The contact points of the tool 1000 provided by the marking feature 1005 can correspond to the number of sclerotomies desired for fixation of the device 100.

[0116] Each marking feature 1005 can project not only by a distance outward from the ring 1030 (or tripod 1020), but also by a distance distally. FIGS. 15A-15D show examples of the tool 1000 incorporating a greater standoff from the marking feature 1005 relative to the ring 1030 as compared to the examples shown in FIGS. 14A-14B. The marking feature 1005 can have a length between its origin in the ring 1030 and its most distal tip 1035 that provides a standoff between about 1 mm and about 10 mm or between about 3 mm and about 6 mm. The tool 1000 can avoid interaction with ophthalmic instruments such as speculums, trocars, etc. on the surface of the eye during surgery. In some examples, the ring 1030 can additionally incorporate crosshairs 1040 for centering (see FIGS. 15H-15I). The distance between the most distal tip 1035 of each marking feature 1005 and the ring 1030 provides a standoff that is high enough to prevent the ring 1030 (or crosshairs 1040 if present) from contacting the cornea during use (see FIGS. 15E-15G).

[0117] The inner diameter of the ring 1030 can be between about 5 mm and about 15 mm (see FIG. 16A). The overall diameter defined by the distal-most tip 1035 of the tool 1000 can be between about 11 mm and about 18 mm, or between about 13 mm and about 17 mm (see FIG. 16B). The marking features 1005 can be symmetrically distributed on the circumference of the ring 1030. For example, if there are three marking features 1005, each can be located on a circumference of about 120 degrees from each other. Each marking feature 1005 can incorporate a bevel or double bevel leading to the distal-most tip 1035 such that the distal-most tip 1035 forms a generally sharp, pointed point suitable for marking the sclera, such as by forming a depression (see FIG. 16A-16D). The bevel for creating the point at the distal-most tip 1035 can extend a length that is between about 0.15 mm and about 1.5 mm. The distal-most tip 1035 can be angled inwardly toward the center of the ring 1030, and the distal-most tip 1035 is offset from the outermost extent of the marking feature 1005 (see FIG. 16D). The offset of the tip 1035 relative to the outermost extent of the marking feature 1005 can be a distance from the outermost extent that is between about 0.15 mm and about 1.5 mm. Each marking feature 1005 can have a length between about 3 mm and about 10 mm, and the angled portion leading to the distal-most tip 1035 can be between 0.15 mm and about 1.5 mm of this length. The distal-most tip 1035 does not need to be sharply pointed to provide a marking function on the sclera. The distal-most tip 1035 can be blunt as shown in FIGS. 14A-B and still be used to mark the sclera. The distal-most tips 1035, whether blunt or pointed, can be used to mechanically mark the sclera by creating multiple indentations or by applying another visual marker to the sclera. For example, the bottom end of each distal-most tip 1035 can be used to transfer a transferable amount of ink or other visually appropriate material from the distal-most tip 1035 to the sclera.

[0118] The externalization of the anchor 125 can be performed using standard tools used in ophthalmology. FIGS. 17C-17D are diagrams showing a snare device 200 for the externalization of the anchor 125. As described elsewhere in this specification, the footplate or anchor 125 is configured to be externalized by sclerotomy (e.g., 23, 25, or 27 gauge sclerotomy). The snare device 200 is configured to grip and release the anchor 125 and / or the fixation arm 120 of the device and to fix them transsclerally. The snare device 200 can include an adjustable loop 205 configured to expand and contract in size. The loop 205 can pass over part or all of the anchor 125. The loop 205 can be tightened so that the opening of the loop 205 decreases and engages firmly with the anchor and / or the fixation arm. The surgeon can use the device 200 having the minimized loop 205 surrounding the fixation arm / anchor to externalize the anchor 125 while minimizing the risk of losing grip of the anchor 125. When the anchor 125 is externalized, the loop 205 can be at least partially opened again to expand the opening area of the loop 205 to release the anchor 125. In a fully or partially open configuration, the loop 205 can have an inner circumference of from about 1.5 mm to about 10.0 mm. In a closed capture configuration, the inner circumference of the loop 205 can be from about 0.25 mm to about 2.5 mm. The snare device 200 is configured so that the loop can grip the anchor 125 and / or the fixation arm 120 without trauma so as not to damage the device 100. For example, the snare device 200 may not have sharply pointed corners. The material of the loop 205 can provide mechanical properties that allow the loop 205 to capture the arm 120 without trauma, repeatedly transition between a large circumferential configuration and a small circumferential configuration, and return to the large circumferential configuration again. The material of the loop 205 can provide a firm grip with a non-traumatic interaction with the fixation arm 120 or the anchor 125. The loop 205 while gripping the fixation arm 120 or the anchor 125 can be deformed to a significant extent during the externalization process. At least a portion of the snare device 200 can be bent.For example, the snare device 200 can be manufactured with a bend near the distal end region, or can be manually bent by the user during use to suit ergonomic needs.

[0119] The loop 205 can be a wire-like structure with a full radius of curvature. The wire-like structure can be a rigid material such as a metal, such as stainless steel, titanium, nitinol, etc. Alternatively, the wire-like structure is constructed from a plastic, such as polypropylene, polyethylene, nylon, Gortex, polyimide, PMMA, or other plastics. Alternatively, the wire-like structure of the loop 205 is made from an elastomeric material, such as a flexible acrylic, polyurethane, silicone, SIBS, or other elastomeric polymer with similar mechanical properties.

[0120] The snare device 200 can be configured to perform a scleral incision and / or function as an intraocular lens grasper. FIGS. 18A-18D show an example of a snare device 200. A loop 205 or other snare feature can extend from a lumen of the device. An opening from the lumen can be at the distal end as shown in FIGS. 17C-17D. The opening from the lumen can be located proximal to the distal end through the side wall of the device as shown in FIGS. 18A-18B, or the sharpened tip can be swaged to extend distal to the orifice where the loop 205 exits the lumen as shown in FIGS. 18C-18D. The device can have additional features to prevent the snare material and the device from being damaged by the sharpened edge of the distal tip 210. For example, the sharpened distal tip 210 of the needle can be covered by a sheath or other element configured to have a lumen and extend beyond the distal tip 210. The outer sheath can provide an atraumatic surface against which the loop 205 can be clamped. Alternatively, the piercing tip 210 can be located at a distance from the opening 215 through which the loop 205 is manipulated, for example, about 0.2 mm to 10 mm away from the opening 215. The device 200 can incorporate a distal tip 210 suitable for performing a sclerotomy. The distal tip 210 can have a variety of shapes, such as a non-coring trocar tip as shown in FIGS. 18A-18B, or a back-bevel needle cannula tip as shown in FIGS. 18C-18D. The geometry of the distal tip 210 can include, but is not limited to, a bevel, a three-sided trocar, a cone, a diamond, a pencil tip, a swaged, a skived, or other pointed shape.

[0121] In yet another example, the anchor 125 can be exteriorized (externalized) using a forceps type device. The forceps can be straight or angled. The forceps device can incorporate a locking feature to enhance the surgeon's grip. The forceps device for exteriorization can transition from a locked state to an unlocked state, or vice versa, via any of a variety of mechanical movements, including twisting, squeezing, and sliding mechanisms, which reduce the range of motion of the forceps once engaged. In some examples, the locking forceps have two gripping surfaces that are locked in a restricted configuration. In other examples, the forceps have three or four gripping surfaces that can be locked in a restricted configuration. The locking or restricted configuration can also encase the anchor 125 in a sheath that aids in the exteriorization procedure. Completely encasing the anchor 125 can limit interference between the anchor and the sclera as the anchor is inserted through the wound. The sheath can define an outermost surface during exteriorization that is configured to optimally interact with the ocular tissue. For example, the outermost surface of the sheath can have a rounded profile (e.g., circular, elliptical, oval, etc.). The sheath can also have a coating to reduce friction with tissue during exteriorization. The sheath can be sufficiently rigid to substantially retain its shape during exteriorization.

[0122] The device described herein can be implanted in the posterior chamber of an eye lacking an intact lens capsule. As described elsewhere herein, at least one of the at least three fixation arms can be biased toward a straight configuration and at least a second of the at least three fixation arms can be biased toward a folded configuration prior to insertion into the posterior chamber. The folded configuration includes an origin portion of the fixation arm that extends away from the lens support structure and a central portion of the fixation arm that has a bend, crease or curve such that an anchor of the end portion is located above or below at least one of a portion of the lens support structure and a portion of the central opening. When the device is inserted into the posterior chamber, at least a portion of the fixation arm in the folded configuration is visualized through the pupil. The anchor of the straight fixation arm can be grasped and externalized through and on a first portion of the sclera. The anchor of the curved fixation arm can be grasped, deployed and externalized through and on a second portion of the sclera. The third portion of the fixation arm can then be grasped through and over the third portion of the sclera, applying tension and externalizing it to position and stabilize the device within the posterior chamber of the eye.

[0123] Materials or combinations of materials suitable for the preparation of the various components of the devices disclosed herein are provided throughout. It should be understood that other suitable materials are contemplated. The device 100 can be constructed from any implant grade material capable of providing the necessary functionality for the lens support structure 105, fixation arms 120, and anchors 125. Materials that can be used in the device can be, but are not limited to, silicone elastomers, fluorosilicone elastomers, polyurethanes, hydrophilic or hydrophobic acrylics, polyolefins, nylons, PVDF, PMMA, polyimides, nitinol, titanium, stainless steel, or other implant grade materials. The device can be made from a combination of materials that are geometrically bonded, chemically bonded or welded to each other, overmolded, encapsulated, or other means for joining multiple materials. A given device element may be made of multiple materials. The fixation arm 120 is constructed from a non-elastic or semi-rigid material common to ophthalmic applications, such as polypropylene, nylon, PVDF, polyimide, PMMA, polyurethane, hydrophilic or hydrophobic acrylic, or high durometer silicone. The fixation arm 120 can incorporate or be formed from a resilient material, such as acrylic, polyurethane, silicone elastomer, or copolymers thereof, that facilitates manipulation of the fixation arm 120 during implantation. In yet another example, the fixation arm 120 can be formed from a semi-rigid or rigid plastic material, such as polypropylene, nylon, PVDF, polyimide, PMMA, polyurethane, hydrophilic or hydrophobic acrylic, or high durometer silicone embedded or coated with a soft elastomeric material, such as acrylic, polyurethane, silicone elastomer, or copolymers thereof.

[0124] In various examples, the description will be made with reference to the drawings. However, a particular example may be implemented without one or more of these specific details or in combination with other known methods and configurations. In this description, numerous specific details, such as specific configurations, dimensions, steps, etc., are set forth in order to provide a thorough understanding of the examples. In other examples, well-known processes and manufacturing techniques not specifically described are detained in order not to unnecessarily obscure the description. References throughout this specification to "one embodiment," "an embodiment," "one example," "an example," and the like, mean that a particular feature, structure, configuration, or characteristic described is included in at least one embodiment or example. Thus, the expressions "one embodiment," "an embodiment," "one example," "an example," and the like appearing in various places throughout this specification do not necessarily refer to the same embodiment or example. Furthermore, particular features, structures, configurations, or characteristics may be combined in any suitable manner in one or more examples.

[0125] The devices and systems described herein may incorporate any of a variety of features. Elements or features of one example of the devices and systems described herein may be incorporated alternatively or in combination with elements or features of another example of the devices and systems described herein. For the sake of brevity, an explicit description of each of these combinations may be omitted, but various combinations are contemplated herein. Furthermore, the devices and systems described herein may be placed in the eye and need not be specifically implanted as shown in the drawings or described herein. The various devices may be implanted, positioned, adjusted, etc., according to a variety of different methods and using a variety of different devices and systems. The various devices may be adjusted before, during, or after implantation. Some representative descriptions of how the various devices are implanted and positioned are provided, but for the sake of brevity, an explicit description of each method for each implant or system may be omitted.

[0126] Use of relative terms throughout the description can indicate relative positions or directions or orientations and are not intended to be limiting. For example, "distal" can indicate a first direction away from a reference point. Similarly, "proximal" can indicate a position in a second direction opposite the first direction. Use of the terms "upper," "lower," "top," "bottom," "front," "side," "rear," and "forward," "rear," "tail," and "leading" are used to establish a relative frame of reference and are not intended to limit the use or orientation of any of the devices described herein in the various instances.

[0127] Although this specification contains many specific details, these should not be construed as limitations on the claims, but rather as descriptions of specific features for particular examples. Certain features described in this specification in the context of separate embodiments can also be implemented in combination in one embodiment. Conversely, various features described in the context of one embodiment can also be implemented in multiple embodiments separately or in any suitable subcombination. Furthermore, although features may be described above as acting in a particular combination and may even be initially claimed as such, one or more features from the claimed combination may in some cases be deleted from the combination, and the claimed combination may be directed to a subcombination or variation of the subcombination. Similarly, although the figures depict operations in a particular order, this should not be understood as requiring such operations to be performed in the particular order shown, or in the sequence shown, or to perform all of the operations shown, in order to achieve desired results. Only a few examples and examples are disclosed. It is to be understood that variations, modifications and extensions to the described examples and examples, as well as other examples, may be made based on the disclosed content.

[0128] In the above description and in the claims, phrases such as "at least one of" or "one or more of" may occur followed by a conjunctive list of elements or features. The term "and / or" may also occur in a list of two or more elements or features. Unless implicitly or explicitly contradicted by the context in which it is used, such phrases are intended to mean any of the listed elements or features individually, or any of the listed elements or features in combination with any of the other listed elements or features. For example, the phrases "at least one of A and B," "one or more of A and B," and "A and / or B" are intended to mean "A only, B only, or both A and B," respectively. A similar interpretation is intended for lists containing more than two items. For example, the phrases "at least one of A, B, and C," "one or more of A, B, and C," and "A, B, and / or C" are intended to mean "A only, B only, C only, both A and B, both A and C, both B and C, or all of A, B, and C," respectively.

[0129] Use of the term "based on" above and in the claims is intended to mean "based at least in part on," allowing for unrecited features or elements.

Claims

1. A device for supporting an intraocular lens within the eye, the device comprising: A lens support structure having an inner peripheral surface that at least partially defines a central opening, such that when the device is implanted in the eye, light passes through the central opening towards the retina; At least three fixing arms, each having a starting portion coupled to the lens support structure and a terminal portion having an anchor for transscleral fixation of the device within the eye. In a stationary state and prior to implantation, the device comprises at least one of the at least three fixing arms in a folded configuration, the at least one fixing arm being flexible and biased towards the folded configuration, the folded configuration comprising a starting portion extending away from the lens support structure, an anchor of the terminal portion located above and / or below at least one of a portion of the lens support structure and a portion of the central opening, and a bend between the starting portion and the terminal portion.

2. The anchor of the at least one fixing arm in the folded configuration is located above and in front of at least one of a portion of the lens support structure with respect to the retina, a portion of the central opening, or both a portion of the lens support structure and a portion of the central opening with respect to the retina, when located in the eye and prior to scleral fixation, according to claim 1.

3. The anchor of the at least one fixing arm in the folded configuration is located below and behind at least one of a portion of the lens support structure with respect to the retina, a portion of the central opening, or both a portion of the lens support structure and a portion of the central opening with respect to the retina, when located in the eye and prior to scleral fixation, according to claim 1.

4. The device according to claim 1, wherein the terminal portion of the at least one fixed arm in the folding configuration overlaps the starting portion.

5. The device according to claim 1, wherein the anchor of the terminal portion of the at least one fixed arm in the folding configuration is visible through the pupil of the eye, in the case of placing the device in the posterior chamber of the eye, but before scleral fixation of the anchor.

6. The device according to claim 1, wherein the anchor of the at least one fixed arm in the folding configuration is located within a certain distance from the central axis of the device, the central axis extending from front to back through the central opening, and the certain distance is not greater than about 4.0 mm.

7. The device according to claim 1, wherein the at least one fixed arm in the folding configuration is curved such that the anchor of the terminal portion of the at least one fixed arm protrudes rearwardly towards the central opening of the device.

8. The device according to claim 1, wherein each of the anchors of the at least three fixed arms is configured for seamless scleral fixation.

9. The device according to claim 1, wherein the lens support structure further comprises an outer periphery, the outer periphery of the lens support structure is non-circular, and the inner peripheral surface is circular.

10. The device according to claim 1, wherein at least a second fixed arm of the at least three fixed arms is biased towards the folding configuration when the device is stationary before implantation.

11. The lens support structure has a shape configured to fit around the intraocular lens and / or with one or more haptics of the intraocular lens, the shape comprising a recess, a concave portion, a channel or a groove for fitting around the intraocular lens and / or with the one or more haptics of the intraocular lens, the device according to claim 1.

12. At least one of the at least three fixation arms comprises a deformable material for facilitating straightening of the fixation arm from the folded configuration to the deployed configuration to facilitate scleral fixation, the device according to claim 1.

13. After scleral fixation of the anchor, the at least one fixation arm applies a tension to the deployed configuration between the starting portion and the ending portion to align the lens support structure with respect to the Z-plane of the eye, the device according to claim 1.

14. The device comprises three fixation arms, two of the three fixation arms being flexible and biased towards the folded configuration, and a third fixation arm being less flexible than the two fixation arms of the three fixation arms and biased towards the deployed configuration, the device according to claim 1.

15. All of the three fixation arms are configured to be disposed under tension, the device according to claim 14.

16. The folded configuration of each of the two of the three fixation arms biases the ending portion towards the central axis of the device, the device according to claim 14.

Images