Devices and methods of using intraocular lenses to support and position them within the eye.

Abstract

An implantable device for supporting an intraocular lens in the eye includes a lens support structure having a central aperture; and one or more fixation arms coupled to the lens support structure and configured to position and stabilize the device within the eye. Related tools, systems, and methods are also provided.

Description

[0001] Cross-references to related applications

[0002] This application is a continuation of co-pending U.S. Patent Application Serial No. 16 / 988,519, filed August 7, 2020, and also claims priority interests under 35 U.S.SC §119(e) to co-pending U.S. Provisional Patent Application Serial No. 63 / 017,423, filed April 29, 2020, and Serial No. 63 / 053,450, filed July 17, 2020. The disclosures of these applications are incorporated herein by reference in their entirety. Technical Field

[0003] This disclosure relates generally to the field of ophthalmology, and more specifically to ophthalmic devices for supporting and positioning intraocular lenses in the eye. Background Technology

[0004] Implantation of an intraocular lens (IOL) requires intraocular support to hold it in the correct position. This is typically achieved through a native capsular bag suspended by small bands (fine, thread-like structures). However, these supporting structures can be damaged by intrinsic factors (such as pseudoexfoliation, Marfan, or Welchmacherani syndrome) or extrinsic factors (such as trauma). Furthermore, lens support can be iatrogenically damaged during the surgical procedure (anterior or posterior segment surgery) or as a late complication of a previous surgery (e.g., due to capsular bag contraction).

[0005] The management of secondary IOL placement in the absence of sufficient capsular or fasciculus support is evolving. Currently, the only FDA-approved solution is anterior chamber IOL placement (ACIOL). An ACIOL is a larger lens that can be positioned anterior to the iris, but over time, these lenses can contribute to uveitis-glaucoma-hypertracentesis (UGH) syndrome, along with endothelial cell loss and corneal decompensation, making them contraindicated in many patients. Modified capsular tension rings (Cionni or Ahmed) can be used off-label (or for purposes other than those specified in the instructions) to provide sutured scleral support for partially weakened capsular bags. However, in cases of substantial capsular or fasciculus damage, the lens must be fixed without these native support structures. Other off-label techniques, such as iris suture IOLs, can be employed, but this is technically difficult and can lead to iris pigment loss, potentially resulting in glaucoma. Finally, the technique of suturing an intraocular lens with an islet sclera is complex, carries the risk of rotation, and the durability of the sutures is unknown; cases of breakage and lens subluxation have been reported. Furthermore, all these techniques force surgeons to use alternative lens types rather than those preferred for their patients. Finally, the timing is crucial because lens calculations are often insufficient during the initial vitrectomy / phacoemulsification, but the surgeon wishes to avoid additional posterior surgery, thus frequently resulting in the implantation of an undesirable lens. Summary of the Invention

[0006] In one aspect, an implantable device for supporting an intraocular lens in the eye is described, comprising a support structure having an outer peripheral surface, an anterior surface, a posterior surface, and a single central aperture extending through the full thickness of the support structure between the anterior and posterior surfaces, the single aperture having a continuous inner circumference. The device includes a plurality of fixation arms coupled to the support structure and configured to be placed under tension to position and stabilize the device within the eye. Each of the plurality of fixation arms has an end coupled to a transscleral anchor for seamless scleral fixation.

[0007] Transscleral anchors can be configured to be non-invasively exposed. Transscleral anchors can be positioned externally to the sclera and internally to the conjunctiva. At least one of the plurality of fixation arms can be substantially non-planar. The plurality of fixation arms may include three fixation arms extending outwardly from the outer peripheral surface of the support structure. At least one of the three fixation arms may be biased toward the center of the device. At least one of the three fixation arms, the first and second fixation arms, may each be biased toward the center of the device. The third fixation arm may have an increased cross-sectional area compared to the first and second fixation arms. The increased cross-sectional area of ​​the third fixation arm may increase its stiffness compared to the stiffness of the first or second fixation arm. The three fixation arms may be uniformly distributed around the outer peripheral surface of the support structure.

[0008] The forward surface can form a stable platform on which the intraocular lens rests during use. The continuous inner circumference can form a uniform, substantially circular shape, while the outer peripheral surface can form a substantially non-circular shape. During 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. During use, the substantially non-circular outer peripheral surface of the support structure can avoid contact with the ciliary body or can contact it at less than 120 degrees. During use, the substantially non-circular outer peripheral surface of the support structure can contact the ciliary process at three different points. The outer peripheral surface of the support structure may include multiple convex angles projecting outward from multiple substantially flat or concave sides. These multiple convex angles may include three convex angles, thereby providing a substantially circular triangular shape for the support structure. The three convex angles can provide anti-rotation functionality in the Z-plane. During use, the three convex angles can provide non-penetrating contact with the ciliary body.

[0009] The support structure may include one or more slits formed in the inner wall defining a central aperture. The support structure may have a thickness that tapers towards the central aperture from a forward surface to a backward surface. At least one of the plurality of fixation arms may include a plurality of anchors along its length, including a transscleral anchor at an end. In use, the transscleral anchor may be configured to be positioned outside the sclera. The transscleral anchor may have a geometry configured to pass through the sclera in a first direction during insertion and configured to resist pull through the sclera in a second opposite direction. When at rest, at least one of the plurality of fixation arms may incorporate (or include) a bend between its origin with the support structure and its end connected to the transscleral anchor, thereby forming a bent fixation arm. The bend may be between 90 degrees and 270 degrees from the origin in both radial and centripetal directions. The bend may be 180 degrees from the origin of the support structure. When at rest, the ends of the bent fixation arms may lie in a plane different from the plane of the support structure, and the transscleral anchor may be positioned above at least a portion of the support structure. The bent fixation arms may incorporate an elastic material or a deformable hinge to facilitate straightening of the bent fixation arms, bringing the ends close to the plane of the support structure. Two fixation arms may be flexible and have an inward bias, and a third fixation arm may be less flexible than the two fixation arms. The transscleral anchor for each of the plurality of fixation arms may be configured to be positioned externally to the sclera. The transscleral anchor may include a central portion and one or more peripheral graspable portions. The central portion may be arranged above the wound, through which the anchor is exposed during implantation. Compared to the graspable portions, the central portion may have increased thickness, height, and / or width. One of the plurality of fixation arms may be mechanically reinforced. Mechanical reinforcement may cause the device to be forward biased during implantation.

[0010] In one related aspect, a method for implanting an anterior capsule device with artificial small band fixation is provided, the device providing a stable platform for placing an artificial lens within the groove of the artificial structure.

[0011] In a related aspect, an implantable device for supporting an intraocular lens in the eye is provided, having a support structure substantially located in a first plane. The support structure has an outer peripheral surface, an anterior surface, a posterior surface, and a single central aperture extending through the full thickness of the support structure between the anterior and posterior surfaces. The single aperture has a continuous inner circumference. The device has three fixation arms coupled to the support structure, configured to position and stabilize the device within the eye. Each of the three fixation arms has an end coupled to a transscleral anchor for seamless scleral fixation. When in a resting state, at least the first of the three fixation arms incorporates a bend between its origin and its end in the support structure, thereby forming a first curved arm. The end of the first curved arm lies in a second plane different from the first plane.

[0012] The transscleral anchor of the first curved arm may be positioned above at least a portion of the support structure. The transscleral anchor of the curved arm may be positioned above at least a portion of the central hole. At least the second of the three fixed arms may have a bend between its origin and its end in the support structure, thereby forming a second curved arm. The end of the second curved arm may be located in a second plane different from the first plane. The transscleral anchor of the second curved arm may be positioned above at least a portion of the support structure. The transscleral anchor of the second curved arm may be positioned above at least a portion of the central hole. The third of the three fixed arms may be straight between its origin and its end in the support structure, thereby forming a straight fixed arm. The straight fixed arm may be less flexible than the first and second curved arms. The first and second curved arms may be biased toward the central axis of the device.

[0013] In a related aspect, an implantable device for supporting an intraocular lens in the eye is provided, having a support structure substantially located in a first plane. The support structure has an outer peripheral surface, an anterior surface, a posterior surface, and a single central aperture extending through the full thickness of the support structure between the anterior and posterior surfaces. The single aperture has an inner peripheral surface with a circumference. The device includes three fixation arms coupled to the support structure and configured to be placed under tension to position and stabilize the device within the eye. Each of the three fixation arms has an end coupled to a transscleral anchor for seamless scleral fixation. The inner peripheral surface forms a uniform, substantially circular shape, while the outer peripheral surface forms a substantially non-circular shape.

[0014] The non-circular shape of the outer peripheral surface may include multiple convex angles projecting outward from multiple sides. These sides may be substantially flat or concave. Each of the three fixing arms may extend outward from a corresponding side of the multiple sides. The support structure may have a circumferentially varying width between the outer and inner peripheral surfaces. Each of the three fixing arms may have a length greater than the distance the multiple convex angles project outward. The forward and backward surfaces of the support structure may taper toward the central axis of the device. The inner and outer peripheral surfaces may be convex, such that the inner peripheral surface projects toward the central axis of the device and the outer peripheral surface projects away from the central axis of the device. The thickness of the support structure from the forward to the backward surface may be from about 0.15 mm to about 1.5 mm. The support structure may be substantially flat. The support structure may incorporate a recess in the forward surface. The support structure may incorporate one or more pillars projecting upward from the forward surface.

[0015] In a related aspect, a device is provided for implantation into the posterior chamber of an eye without an intact capsular bag. The device includes a support structure having a central opening. The support structure is adapted to provide support for an artificial intraocular lens. After implantation into the eye, the device and the artificial intraocular lens are adapted to allow light to pass through the opening and the artificial intraocular lens. The device includes at least three fixation arms extending substantially perpendicularly from the support structure. Prior to implantation, one of the at least three fixation arms extends from the support structure in an deployed configuration, and at least two of the at least three fixation arms extend from the support structure in a folded configuration. Prior to implantation, one of the at least three fixation arms is biased toward the deployed configuration, and at least two of the at least three fixation arms are biased toward the folded configuration. During implantation, each of at least two of the at least three fixation arms is deployed. Each of the at least three fixation arms includes a non-invasive distal anchor portion for seamless, transscleral fixation of the device within the posterior chamber.

[0016] In one related aspect, a device for implantation in the posterior chamber of an eye without an intact capsular bag is provided. The device includes a support structure having a central aperture extending through the full thickness of the support structure. The device includes a plurality of fixation arms, each having a starting portion at the support structure and an end portion coupled to a non-invasive anchor for seamless, transscleral fixation. Prior to transscleral fixation of the anchor, the plurality of fixation arms may include a flexed fixation arm that flexes between its starting portion and its end portion, allowing at least a portion of the flexed fixation arm to be visualized through the pupil of the eye.

[0017] After transscleral fixation of the anchors, each of the plurality of fixation arms can be tensioned between its starting and ending portions to align the support structure with respect to the Z-plane of the eye. The support structure is adapted to provide support for the intraocular lens, and the central aperture is adapted to allow light to pass through the central aperture and the intraocular lens supported by the support structure. A flexed fixation arm can be flexed anteriorly, and its non-invasive anchor can be positioned above at least a portion of the support structure. A flexed fixation arm can be flexed posteriorly, and its non-invasive anchor can be positioned below at least a portion of the support structure.

[0018] In a related aspect, a method for implanting a device into the posterior chamber of an eye without an intact capsular bag 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 distal portion including an anchor. Before insertion into the posterior chamber, at least one of the at least three fixation arms is biased toward a linear 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 including a bend, fold, or flexion; and an anchor positioned above or below at least one of a portion of the lens support structure and a portion of the central opening. The method includes grasping the anchor of at least one of the at least three fixation arms and passing the anchor through and over a first portion of the sclera. The method includes grasping the anchor of a second fixation arm, unfolding the folded configuration of the second fixation arm, and passing the anchor of the second fixation arm through and over a second portion of the sclera. The method includes grasping the anchor of the third of at least three fixation arms, tensioning the third fixation arm, and making the anchor of the third fixation arm pass through and protrude above the third part of the sclera to position and stabilize the device in the posterior chamber of the eye.

[0019] In one related aspect, a device is provided for supporting an artificial intraocular lens in an eye. The device includes a lens support structure having a central opening. When the device is implanted in the eye, light can be transmitted to the retina through the central opening. The device includes at least three fixation arms, each of the at least three fixation arms having a starting portion coupled to and extending outwardly from the lens support structure and an ending portion having an anchor for securing the device transscleral within the eye. Prior to implantation, at least one of the at least three fixation arms is biased toward a folded configuration that incorporates a bend between the starting and ending portions, the bend positioning the anchor of the ending portion to overlap at least a portion of the lens support structure.

[0020] An anchor in at least one fixation arm in a folded configuration, when positioned in the eye and prior to scleral fixation, may be positioned above at least a portion of the lens support structure and anterior to the lens support structure relative to the retina. The anchor positioned above at least a portion of the lens support structure may be positioned above and anterior to the central opening of the lens support structure relative to the retina. At least a first portion of the anchor may be above and anterior to the central opening, and at least a second portion of the anchor may be above and anterior to the lens support structure relative to the retina. An anchor in at least one fixation arm in a folded configuration, when positioned in the eye and prior to scleral fixation, may be positioned below at least a portion of the lens support structure and posterior to the lens support structure relative to the retina. The anchor positioned below at least a portion of the lens support structure may be below and posterior to the central opening of the lens support structure relative to the retina. At least a first portion of the anchor may be below and posterior to the central opening, and at least a second portion of the anchor may be below and posterior to the lens support structure relative to the retina. The folded configuration may include an end portion folded above or below the starting portion of at least one fixation arm. The distal portion of at least one fixation arm in the folded configuration may overlap with the initial portion. When the device is placed in the posterior chamber of the eye, but before the transscleral anchor, the anchor of the distal portion of the at least one fixation arm in the folded configuration is visible through the pupil of the eye. The anchor of the at least one fixation arm in the folded configuration may be positioned at a distance from the central axis of the device, which extends from front to back through the central opening. This distance may not exceed approximately 4.0 mm. The at least one fixation arm in the folded configuration may be flexed such that the anchor of the distal portion of at least one fixation arm protrudes posteriorly toward the central opening of the device. The anchor may be suitable for seamless, transscleral fixation. The lens support structure may be generally annular.

[0021] The lens support structure may also have an outer periphery and an inner periphery. A central opening may be defined by the inner periphery. The outer periphery of the lens support structure may be substantially non-circular, while the inner periphery may be substantially circular. The lens support structure may include an outer periphery. This outer periphery may include a plurality of convex angles projecting radially away from the central opening. A first count of the plurality of convex angles may be equal to a second count of at least three fixation arms. Each convex angle may be spaced apart between adjacent fixation arms. Each convex angle may be symmetrically spaced around the outer periphery of the lens support structure between adjacent fixation arms. Each of the at least three fixation arms may be symmetrically spaced around the outer periphery of the lens support structure between adjacent convex angles. The plurality of convex angles may consist of three convex angles. The at least three fixation arms may consist of three fixation arms. The plurality of convex angles may include at least three convex angles, thereby providing a substantially circular triangular shape for the lens support structure. When implanted, the at least three convex angles provide non-penetrating contact with the ciliary tissue in the eye. At least two of the at least three fixation arms may be biased toward a folded configuration before implantation. All of the at least three fixation arms may be biased toward a folded configuration prior to implantation. At least the second of the at least three fixation arms may be biased toward an unfolded configuration prior to implantation. The at least second fixation arm may have a larger cross-sectional area than the at least one of the at least three fixation arms to provide increased stiffness relative to the at least one of the at least three fixation arms. The lens support structure may form a substantially planar surface. The lens support structure may include a geometry adapted to match the periphery of an intraocular lens or one or more tactile features of an intraocular lens. The geometry may be a concavity, recess, channel, or groove forming at least a portion of the inner periphery of the lens support structure. At least one of the at least three fixation arms may include a deformable material to facilitate straightening of the fixation arm from a folded configuration to an unfolded configuration, thereby facilitating transscleral fixation. After transscleral fixation of the anchor, at least one fixation arm may be tensioned between its starting and distal portions into an unfolded configuration and align the lens support structure with respect to the Z-plane of the eye.

[0022] The device may include three fixation arms. Two of the three fixation arms may be flexible and biased toward a folded configuration. The third fixation arm may be less flexible than the two flexible fixation arms and may be biased toward an unfolded configuration. All three fixation arms may be configured to be placed under tension. The folded configuration of each of the two of the three fixation arms may bias the distal portion toward the central axis of the device. When at least one of the three fixation arms is biased toward a folded configuration, the lens support structure may be biased toward a substantially flat or planar construction.

[0023] In a related aspect, a device is provided for supporting an artificial intraocular lens in an eye. The device includes a lens support structure having an inner peripheral surface that at least partially defines a central opening. When the device is implanted in the eye, light can pass through the central opening to the retina. The device includes at least three fixation arms. Each of the at least three fixation arms has a starting portion coupled to the lens support structure and an ending portion having an anchor for securing the device transscleral within 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 the starting portion extending away from the lens support structure, and the anchor of the ending 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 ending portion.

[0024] An anchor in at least one fixation arm in a folded configuration, when positioned in the eye and prior to scleral fixation, can be positioned above and anterior to a portion of the lens support structure relative to the retina. An anchor in at least one fixation arm in a folded configuration, when positioned in the eye and prior to scleral fixation, can be positioned above and anterior to a portion of the central opening relative to the retina. 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 relative to the retina. An anchor in at least one fixation arm in a folded configuration, when positioned in the eye and prior to scleral fixation, can be positioned below and posterior to a portion of the lens support structure relative to the retina. An anchor in at least one fixation arm in a folded configuration, when positioned in the eye and prior to scleral fixation, can be positioned below and posterior to a portion of the central opening relative to the retina. 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 relative to the retina. The folding configuration may include an end portion folded above or below the starting portion of at least one fixation arm. The end portion of the at least one fixation arm in the folding configuration may overlap with the starting portion. Before the device is placed in the posterior chamber of the eye but before the transscleral anchor is applied, the anchor of the end portion of the at least one fixation arm in the folding configuration is visible through the pupil of the eye. The anchor of the at least one fixation arm in the folding configuration may be positioned at a distance from the central axis of the device, which extends from front to back through the central opening. This distance may not exceed approximately 4.0 mm. The at least one fixation arm in the folding configuration may be flexed such that the anchor of the end portion of the at least one fixation arm protrudes rearward toward the central opening of the device. The anchor may be suitable for seamless, transscleral fixation.

[0025] The lens support structure can be generally annular. The lens support structure may also include an outer periphery and an inner periphery. The outer periphery may be substantially non-circular while the inner periphery may be substantially circular. The lens support structure may also include an outer periphery comprising a plurality of convex angles projecting radially away from a central opening. A first count of the plurality of convex angles may be equal to a second count of at least three fixation arms. Each convex angle may be spaced apart between adjacent fixation arms. Each convex angle may be symmetrically spaced around the outer periphery of the lens support structure between adjacent fixation arms. Each of the at least three fixation arms may be symmetrically spaced around the outer periphery of the lens support structure between adjacent convex angles. The plurality of convex angles may consist of three convex angles, and the at least three fixation arms may consist of three fixation arms. The plurality of convex angles may include at least three convex angles, thereby providing the lens support structure with a substantially rounded triangular shape. When implanted, the at least three convex angles provide non-penetrating contact with the ciliary tissue in the eye.

[0026] At least two of the at least three fixation arms may be biased toward a folded configuration before implantation. All of the at least three fixation arms may be biased toward a folded configuration before implantation. At least the second of the at least three fixation arms may be biased toward an unfolded configuration before implantation. The at least second fixation arm may have a larger cross-sectional area than the at least one of the at least three fixation arms to provide increased stiffness of the at least second fixation arm relative to the at least one of the at least three fixation arms.

[0027] The lens support structure can provide a substantially planar surface. The lens support structure may include a geometry adapted to match the periphery of an artificial lens or one or more tactile features of the artificial lens. This geometry may include a concavity, recess, channel, or groove forming at least a portion of the inner periphery of the lens support structure.

[0028] At least one of the at least three fixation arms may include a deformable material to facilitate straightening of the fixation arm from a folded configuration to an unfolded configuration in order to facilitate transscleral fixation. After transscleral fixation of the anchor, the at least one fixation arm may be tensioned between its starting and distal portions into an unfolded configuration and align the lens support structure with respect to the Z-plane of the eye. The device may include three fixation arms. Two of the three fixation arms may be flexible and may be biased toward a folded configuration. A third fixation arm may be less flexible than the two flexible fixation arms and may be biased toward an unfolded configuration. All three fixation arms may be configured to be placed under tension. The folded configuration of each of the two of the three fixation arms may bias the distal portion toward the central axis of the device. The lens support structure may be biased toward a substantially flat or planar construction, while at least one of the at least three fixation arms may be biased toward a folded configuration.

[0029] In some variations, one or more of the following may be optionally included in any feasible combination of the methods, devices, apparatuses, and systems described above. Further details are set forth in the accompanying drawings and the description below. Other features and advantages will be apparent from the description and drawings. Attached Figure Description

[0030] These and other aspects will now be described in detail with reference to the following accompanying drawings. Generally, the drawings are not drawn to absolute or relative scale, but are intended to be illustrative. Furthermore, the relative placement of features and elements may be modified for clarity of illustration.

[0031] Figure 1 A top view of an embodiment of the device is shown;

[0032] Figure 2 This shows a support IOL deployed in the eye. Figure 1 The device;

[0033] Figure 3 It shows Figure 1 The device was deployed to support the cross-sectional view of the IOL;

[0034] Figure 4 This illustrates the support structure for the IOL implanted in the eye. Figure 1 A cross-sectional view of the device;

[0035] Figure 5 It shows Figure 1 A top view of the device, where dashed lines indicate how the device is cut to facilitate optical capture;

[0036] Figure 6 It shows Figure 1 A top view of the device, in which flaps are integrated into the lens support structure to facilitate optical capture;

[0037] Figures 7A-7B Various implementations of the design for anchor plates are shown;

[0038] Figures 8A-8C Another embodiment of the anchoring pad connected to the end of the fixed arm is shown;

[0039] Figure 9 A top view of an embodiment of the device having multiple anchors on each fixed arm is shown;

[0040] Figure 10 and Figure 11 Perspective and top views of an embodiment of the device for supporting the IOL are shown, wherein two of the fixing arms are bent and biased inward toward the center of the device, while one fixing arm is straight.

[0041] Figure 12 An embodiment of a device for supporting an IOL is shown, wherein two fixed arms are bent and biased inward toward the center of the device, while one fixed arm is straight and has a geometry that makes it more rigid than the other fixed arms.

[0042] Figure 13 It shows that it was implanted Figure 12 A top view of the device's eye;

[0043] Figures 14A-14B Different implementations of a sclerotomy guidance tool that can be used to assist in the identification and marking of sclerotomy sites are shown;

[0044] Figures 15A-15D Various views of another embodiment of the sclerotomy guide tool are shown;

[0045] Figure 15E-15G It shows the position above the cornea. Figures 15A-15D Sclerotomy guiding tools;

[0046] Figure 15H-15I It shows a crosshair Figures 15A-15D Sclerotomy guiding tools;

[0047] Figures 16A-16D It shows Figures 15A-15D Additional view of the sclerotomy guide tool;

[0048] Figures 17A-17B A straight, leading retaining arm is shown, which is designed with a forward biasing device to prevent backward drift during the exposure of the anchor plate;

[0049] Figure 17C-17D A snare device is shown that surrounds the leading fixing arm and is used to expose the anchoring pad.

[0050] Figure 17E It shows Figure 17D A cross-sectional view of the device;

[0051] Figures 18A-18B An additional embodiment of the snare device for manipulating and displaying the pad is shown;

[0052] Figure 18C-18D An additional embodiment of the snare device for manipulating and displaying the pad is shown;

[0053] Figure 19A Another embodiment of the device is shown, prior to implantation, and having a protrusion extending upward from the forward surface of the support structure and a fixation arm offset inward toward the center of the device.

[0054] Figure 19B-19CThis shows the procedure after implantation, with the IOL positioned above the central hole and each fixation arm tensioned. Figure 19A The device;

[0055] Figure 20A Another embodiment of the device prior to implantation is shown, which has a recess in the forward surface of the support structure and a fixation arm biased inward toward the center of the device.

[0056] Figure 20B This shows the procedure after implantation, with the IOL positioned above the central hole and each fixation arm tensioned. Figure 20A The device;

[0057] Figure 20C yes Figure 20B A cross-sectional view of the device shows the periphery of the IOL optics positioned on a recess surrounding the central aperture;

[0058] Figures 21A-21B Another embodiment of the device combining an enlarged central aperture and multiple leaflets is shown;

[0059] Figure 22A An embodiment of the device is shown, which has a fixation arm biased toward a folded configuration, so that the fixation arm bends inward such that the anchor is positioned in front of and overlaps with a portion of the lens support structure and a portion of the central opening;

[0060] Figure 22B An embodiment of the device is shown, which has a fixation arm biased toward a folded configuration, so that the fixation arm bends inward such that the anchor is positioned in front of and overlaps with a portion of the lens support structure;

[0061] Figures 23A-23B An embodiment of the device is shown, which has a fixation arm biased toward a folded configuration, so that the fixation arm bends inward so that the anchor is held in the plane of the lens support structure;

[0062] Figures 24A-24F A related embodiment of a device having a canopy configured to accommodate an IOL is shown;

[0063] Figures 25A-25C Another embodiment of the device with a canopy configured to accommodate IOL is shown;

[0064] Figures 26A-26E Another embodiment of the device with a canopy configured to accommodate IOL is shown;

[0065] Figure 27 Another embodiment of a device having a canopy configured to accommodate an IOL is shown.

[0066] It should be understood that the accompanying figures in this article are for illustrative purposes only and do not imply that they are drawn to scale. Detailed Implementation

[0067] This disclosure relates generally to the field of ophthalmology, and more specifically to ophthalmic devices, including artificial support structures that can be used to support an intraocular lens (IOL) or other ophthalmic implants when the small band and capsular support have been damaged.

[0068] The most common treatment for aphakia resulting from cataract lens removal is placement of the IOL within the native lens capsule. The capsule, with its anterior and posterior components forming the cavity, is supported by a band of small bands, providing a stable structure for IOL support. In some cases, the posterior aspect of the capsule is incomplete or ruptured during cataract surgery, requiring a more reliable platform for IOL placement. If the anterior aspect of the capsule and its associated band of small bands are intact, the IOL can be placed between the anterior capsule and the iris in a location called the “groove.” In another segment of cataract surgery cases, the anterior capsule or band of small bands is incomplete, making groove placement unsafe or impossible. The device described herein can be implanted in the posterior chamber of an eye without an intact capsule. The device described herein creates an artificial anterior capsule with artificial band of small bands for fixation. The device described herein provides a stable platform structure fixed to the eye and thus reproduces the native anterior capsule and band of small bands, allowing IOL placement in an artificially constructed groove.

[0069] The device described herein addresses the problems of other support / positioning techniques known in the art. Anterior chamber intraocular lenses placed in front of the iris, due to their instability within the eye, can lead to corneal decompensation, glaucoma, and hemorrhage over time. Lenses sutured to the iris are technically difficult to implant due to iris abrasions and carry risks of hemorrhage and glaucoma. Sutures to the sclera are also technically challenging. In some cases, suture erosion / breakage requires additional surgery and carries the potential risk of blinding infection.

[0070] The device described herein can be implanted seamlessly, eliminating the risk of suture breakage. The seamless transscleral fixation method allows for easier placement and secure attachment without concern for suture loosening or breakage. The device stably holds the IOL, providing reliable refractive results without worry, depending on its known location. The device also allows for posterior placement, significantly reducing the risk of iris, corneal, or corneal damage. Posterior implantation of the iris and cornea eliminates or reduces the risk of corneal injury, iris hemorrhage, and glaucoma. Compared to current techniques such as ACIOL, iris-sutured lenses, or scleral-sutured lenses, the device described herein reduces the risk of complications. The device described herein is designed to accommodate and support a variety of different intraocular lenses. Therefore, the selected lens can be implanted at the time of surgery or at a later date. The device described herein replicates the natural lens capsule and is particularly suitable for implantation in the posterior chamber of eyes without an intact capsular bag. For example, in cases of scleral capsule anterior component and / or scleral plexus dysfunction, the device described herein can create an artificial anterior capsule with artificial scleral plexus fixation, providing a scaffold or stable platform structure and an artificially constructed groove. The fixation arm can be externally projected as needed for scleral support / fixation.

[0071] Figure 1-4 An embodiment of device 100 is illustrated. Device 100 may include a lens support structure 105, a central opening or aperture 115, and one or more fixation arms 120 on, against, or within the lens support structure 105. The central aperture 115 prevents device 100 from interfering with a patient's vision and is adapted to allow light to pass through the aperture 115 and the IOL 110 positioned on device 100. The size of the central aperture 115 allows light to pass through the device without any optical interference. Light can pass through the device to the retina and is only affected by the optics of the IOL. One or more fixation arms 120 can position and stabilize device 100 within the eye. The lens support structure 105 may include an outer periphery 111 and an inner periphery 109, and the central aperture 115 may be defined by the inner periphery 109. The lens support structure 105 may be generally annular, although the outer periphery 111 of the lens support structure 105 does not need to be circular, as will be discussed in more detail below. The outer periphery 111 of the lens support structure may be substantially non-circular, while the inner periphery 109 is substantially circular.

[0072] Figure 1 A top view of the device 100 is shown, illustrating the lens support structure 105, the central hole 115, and the fixation arm 120. Figure 2A model of the eye is shown in a 3 / 4 view with a device 100 deployed to support the IOL 110 (iris shown as transparent). The lens support structure 105 can act as a support for the IOL 110 during optimal implantation and as a protector to prevent the IOL 110 from falling into the posterior chamber during implantation. The lens support structure 105 can replace the native lens capsule, particularly in cases where anterior and associated fasciculus dysfunction makes groove placement of the IOL unsafe or impossible. Placing the lens support structure 105 in a patient without a functional capsule can create an anterior capsular device. The fixation arm 120 provides artificial fasciculus fixation, stabilizing the lens support structure and serving as a stable platform for placing the intraocular lens within the artificially constructed groove. Figure 3 A cross-sectional view of an eye model and a device 100 deployed to support the IOL 110 is shown. Figure 4 A cross-sectional view of an eye model illustrates how optical capture techniques can be used to deploy the lens to support the IOL. Figure 4 The cornea 5, iris 10, ciliary body 15, sclera 20, ciliary sulcus 25, and pupil 30 defined centrally by the iris 10 are shown.

[0073] In some embodiments, the support structure 105 may be substantially flat or planar. The support structure 105 may have a forward surface 1210 facing forward of the eyes and a rearward surface 1215 facing backward of the eyes during use (see [link to relevant documentation]). Figure 17E The planar support structure 105 can serve as a platform against which the IOL can be positioned. The front and rear surfaces of the planar structure do not need to include any protrusions, channels, or capturing elements to hold the IOL relative to it. For example, the support structure 105 can create an artificial front section of the pouch against which the IOL can be positioned, but it is not necessary to hold the IOL within an inner surface. Therefore, during use, the IOL can be completely held outside the support structure 105, and there are no protrusions, extensions, or other surfaces relative to the IOL for positioning, except for the substantially planar surface of the support structure 105. Thus, each of the front and rear surfaces can be a substantially smooth planar surface without any protrusions or extensions above it. Each of the front and rear surfaces may also be without any notches, grooves, dents, or openings, except for the central hole 115 extending through it. The substantially flat support structure 105 may taper toward the central hole 115. The tapering edge or inner wall 109 of the defining hole 115 has a front-to-back thickness that is less than the front-to-back thickness of the support structure away from the hole 115.

[0074] In other embodiments, the support structure 105 may incorporate (or include) one or more protrusions extending away from at least one of the forward and backward surfaces. Figures 19A-19C An embodiment of a support structure 105 with a plurality of posts 106 is shown, which protrude upward away from the forward surface near a central aperture 115. The plurality of posts 106 can be positioned around the central aperture 115 such that they surround the optics of the IOL when the IOL is positioned above the aperture 115 (see [link to documentation]). Figure 19B-19C The posts 106 can abut or be close to the periphery of the optics, such that the IOL is received and centered by the posts 106 to limit translational and / or rotational movement of the IOL relative to the support structure 105. The posts 106 can also be positioned on the forward (or backward) surface so that they engage with the tactile area of ​​the IOL extending outward from the optics. The posts 106 can be arranged to accommodate most common IOL designs.

[0075] In other embodiments, the support structure 105 may optionally or additionally include a recess in at least one of the forward or backward surfaces, the size and shape of which are designed to receive the IOL (see more detailed description below). Figures 20A-20C The recess may be a centrally facing inward groove to accommodate an IOL and / or an IOL haptics (or haptics), for example, as described in PCT Publication WO2020 / 086312, published on 30 April 2020, which is incorporated herein by reference.

[0076] Figures 20A-20C Another embodiment of the device 100 with a support structure 105 is shown, the support structure 105 including a recess 104 located within a forward surface. The recess 104 may form a lip around a central aperture 115, the dimensions of which are designed to engage with and abut against the periphery of the optics of the IOL and support the periphery of the optics of the IOL (see [link]). Figure 20C The recess 104 in the central 6.0-7.0 mm portion of the support structure 105 can restrict the translational movement of the optical device. The recess 104 can be additionally combined with a concave, dished-out section to increase the interface surface area between the IOL and the support structure 105. The recess 104 can be combined with one or more features to additionally prevent rotational movement about the visual axis or central axis CA of the device. Figure 24A-2 5F, 25A-25C and 26A-26E show devices incorporating recesses in which IOL can be received, and additional embodiments are described in more detail below.

[0077] Regardless of whether the support structure 105 is recessed and / or combined with one or more protrusions from its surface, the front-to-back thickness of the support structure 105 is minimized to avoid affecting the iris 10.

[0078] The support structure 105 may include one or more surface features in or on the forward surface 1210 and / or the backward surface 1215. Figure 1 The support structure 105 is shown to include a surface feature 118 on the forward surface 1210, which can be used to position the device 100 during implantation. The surface feature 118 can be engaged by forceps or other implantation tools to help manipulate the device 100 during implantation.

[0079] The central hole 115 can extend from the forward surface 1210 through the full thickness of the support structure 105 to the rear surface 1215, such that the support structure 105 additionally includes an inner wall 109 having an inner peripheral surface defining the central hole 115 and an outer wall 111 having an outer peripheral surface defining the overall shape of the support structure 105 (see...). Figure 1 and 17E This can provide the lens support structure 105 with a substantially annular shape. However, the annular lens support structure 105 does not need to be circular on both its inner and outer peripheral surfaces. The inner peripheral surface may have a circumference and form a uniform, substantially circular shape, while the outer peripheral surface may form a substantially non-circular shape. As will be discussed in more detail below, the non-circular shape of the outer peripheral surface includes a plurality of convex angles 107 projecting outward from a plurality of sides 108. The plurality of convex angles 107 may project radially away from the central aperture 115. As described elsewhere herein, the plurality of sides 108 may be substantially flat or concave. In some embodiments, the device includes at least three fixation arms 120 coupled to the lens support structure 105, configured to be placed under tension to position and stabilize the device within the eye. Each of the three fixation arms 120 may extend outward from a corresponding side of the plurality of sides 108. Thus, the lens support structure 105 may have a width that varies around the circumference between the outer and inner peripheral surfaces. The central aperture 115 is designed to allow vision through the device. In some embodiments, the support structure 105 is substantially flat and the IOL is located on the forward (or backward) surface of the support structure 105, but is not held or contained by the central aperture 115. In other embodiments, the support structure 105 is generally planar, but includes a recess 104 surrounding the central aperture 115, such that the IOL located on the forward surface of the support structure 105 engages with a lip formed by the recess 104 (see [link to relevant documentation]). Figure 20CThe support structure (and therefore the central hole 115) can have a minimized front-to-back thickness. The thickness of the support structure 105 between the forward surface 1210 and the rearward 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 and still provide sufficient support for the IOL, for example, because the fixed arm 120 is under tension. The inner peripheral surface or inner wall 109 defining the central hole 115 can be smooth and without any concavity, groove, channel or other surface features. In some embodiments, the inner peripheral surface or inner wall 109 is convex and protrudes toward the central axis CA of the device, and the outer peripheral surface or outer wall 111 is also 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 form the cross-sectional shape of the support structure 105 when cut through the center of the central hole 115 forming a pair of round rods. In some embodiments, the forward surface 1210 and the backward surface 1215 each taper toward the central hole 115, such that the inner peripheral surface of the inner wall 109 is shaped into a single narrow ridge or point 1230 protruding toward the central axis CA of the device (see [link to relevant documentation]). Figure 17E ).

[0080] The center hole 115 can also be the only hole extending through the support 105, so that the support 105 has only a single hole extending through its full thickness. The inner diameter of the hole 115 is designed to be generally universal for a wide range of IOL types. The size of the hole 115 is designed so that the support 105 substantially avoids overlap with the optics of the IOL. Conventional IOLs typically have optics with an outer diameter of 6 mm, although this size may vary depending on the IOL. Devices with a center hole 115 inner diameter of less than 5.0 mm down to about 4.0 mm can be used with certain IOLs. Devices with a center hole 115 inner diameter between 5.0 mm and about 6.0 mm can be used with most IOLs, making the device virtually universal for use with any conventional tactilely stable IOL. The minimum inner diameter of hole 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 about 10 mm, and any range therein.

[0081] The inner diameter of aperture 115 can be larger than the outer diameter of the IOL optical device. Figures 21A-21BAn embodiment of a device 100 with a central aperture 115, the inner diameter of which is larger than that of most IOL optics, is shown. The device 100 may include a plurality of leaflets 126 configured to support optics of the IOL. The leaflets 126 may project inwardly such that they extend within the opening of the central aperture 115. The leaflets 126 may support the optics on their forward surface or may be deflected such that the optics are transferred to and supported by the rearward surface of the leaflets 126. The tactile elements of the IOL may remain on the forward surface of the support 105, and the optics of the IOL may be positioned on the rearward surface of the leaflets 126, thereby maintaining the Z-position of the IOL. The leaflets 126 may be of full thickness or partial thickness. This means that the leaflets 126 may be as thick as or thinner than the support structure 105. The leaflets 126 may originate from the forward surface of the support 105 (see [link to documentation]). Figure 21A Leaflet 126 can also be derived from the rearward surface of support 105 (see...). Figure 21B If originating from the rearward surface, the optics of the IOL can be positioned within a recess formed by the forward surfaces of the central aperture 115 and the leaflets 126. The device 100 may include one, two, three, or more leaflets 126. In one embodiment, the device 100 includes three leaflets 126 and three retaining arms 120. Each of the three leaflets 126 may be arranged symmetrically about the support 105 such that each leaflet 126 is substantially aligned with the starting point of a corresponding one of the retaining arms 120. Figures 21A-21B The diagram shows each of the curved fixing arms 120a, 120b buckling from its origin at the support structure 105 to be positioned substantially above its corresponding leaflet 126. The leaflet 126 may define an inner diameter narrower than the inner diameter of the central aperture 115. The narrower inner diameter of the leaflet 126 may 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 may 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.

[0082] One or more of the fixing arms 120 may be substantially straight between their origin and end of the support structure 105. A straight fixing arm or leading fixing arm 120 may extend along a single longitudinal axis L between the origin 103 and end 102 without any bending or buckling away from the single longitudinal axis L (see [link to documentation]). Figures 17A-17BOne or more straight fixing arms 120 may extend perpendicularly to the outer peripheral surface of the outer wall 111 of the support structure 105. The longitudinal axis L of one or more straight fixing arms 120 may be positioned perpendicularly to the outer peripheral surface of the outer wall 111. The plane of the front surface 1210 of the support structure 105 and the longitudinal axis L of one or more straight fixing arms 120 may be parallel to each other, as may the plane of the rear surface 1210 of the support structure and the longitudinal axis L.

[0083] One or more fixation arms 120 may be transscleral fixation arms, designed to be non-invasively exposed and held in place solely by their geometry and mechanical properties, i.e., without the need for sutures or glue. The exposed portion or anchor 125 (also referred to herein as an anchoring pad or pad) at the peripheral end (also referred to herein as the distal end or distal portion) of the fixation arm 120 may be located subconjunctivally to anchor the arm 120 in place. The anchor 125 of the fixation arm 120 may have a robust but low-profile geometry to maintain stability and prevent re-entry into the eye and minimize conjunctival erosion. Additionally, the fixation arms 120 of the device 100 may be manufactured in a manner that facilitates easy visualization and manipulation of the device preoperatively. At least one of the fixation arms 120 may be manufactured to have a substantially non-planar geometry at rest and then manipulated into a planar configuration during the implantation process and, for example, when placed under tension.

[0084] The device 100 may include one, two, three, or more fixation arms 120. In a preferred embodiment, the device 100 includes three fixation arms 120 arranged symmetrically or equidistantly around the periphery of the support structure 105. The fixation arms 120 can center the lens support structure 105 and provide sufficient support for long-term stability. In some embodiments, this can be achieved with a single fixation arm 120. In other embodiments, one or more fixation arms include three fixation arms 120 arranged symmetrically around the periphery of the lens support structure. The fixation arms 120 may be constructed of a semi-rigid material or may have a geometry that provides sufficient structural stiffness.

[0085] The device 100 may also comprise only two fixation arms 120. When implanted and anchored via the sclera, these fixation arms 120 may be under equal and opposite tension. Alternatively, the fixation arms 120 may be asymmetrical, such that one fixation arm 120 is under tension while the other has the stiffness and length to function as a rigid spacer element. A rigid or spring-loaded fixation element may rely on penetration of adjacent tissue or wedging into place. Once positioned, the tensioned fixation element may rely on slight stretching or expansion of the material. As described elsewhere herein, one or both of the fixation arms 120 may be configured with an inwardly biased or folded configuration, in which the fixation arm is biased toward the anterior flexion. The fixation arms 120 may have a paddle-like geometry that resists rotation when engaged with ocular tissue.

[0086] The device 100 may also include three or more retaining arms 120. The three retaining arms 120 may provide the device 100 with a defined retaining plane substantially parallel to the Z-plane (vertical plane) of the eye. The retaining arms 120 may be designed and deployed such that each retaining arm 120 is under equal and opposite tension. Alternatively, one or more retaining arms 120 may be designed with stiffness and length that allow them to function as rigid spacer elements. Zero, one, two, or all three or more of the retaining arms 120 may be manufactured with an inwardly biased design or biased toward the center of the device or the central axis CA of the device (see [link to relevant documentation]). Figure 10-13 (17B-17E, 19A, 20A, 21A-21B, 22A-22B, 23A-23B, 24A-24F, 25A-25C, and 26A-26E). The inwardly biased fixation arm 120 may extend from the support structure and have a folded configuration prior to implantation. At least one, but less than all, of the fixation arms may be biased or flexed as described herein. As described herein, at least two, but less than all, may be biased or flexed. In some embodiments, all fixation arms 120 may be biased or flexed. The device may include three fixation arms, wherein two of the three fixation arms are flexible and biased toward a folded configuration, while a third fixation arm is less flexible than the other two and biased toward an unfolded configuration. The folded configuration of each fixation arm may bias the distal portion of the fixation arm toward the central axis CA of the device. The lens support structure may be biased toward a substantially flat or planar configuration, while one or more fixation arms may be biased toward a non-substantially flat or planar folded configuration.

[0087] Once implanted and fixed via the sclera, the inwardly biased arms can be extended or extended from their folded, inwardly biased configuration. In a preferred embodiment, two fixation arms 120 have an inwardly biased geometry, while the third fixation arm 120 has an increased cross-sectional area—thus increasing its stiffness. The inwardly biased fixation arms 120 may incorporate bends between the arm and the starting point and end point of the lens support structure 105. The two bent fixation arms 120 may be biased toward the central axis CA of the device toward a folded configuration.

[0088] In one embodiment, the device 100 may include at least three fixation arms 120. Prior to implantation, one of the at least three fixation arms may extend from the support structure in an unfolded configuration, while at least two of the at least three fixation arms extend from the support structure in a folded configuration. Furthermore, prior to implantation, one of the at least three fixation arms may be biased toward the unfolded configuration, while at least two of the at least three fixation arms may be biased toward the folded configuration. After implantation, each arm biased toward the folded configuration may be unfolded.

[0089] Each fixation arm 120 may include a starting portion 103 at the support structure 105 and an end portion 102 connected to a non-invasive anchor 125 for seamless, transscleral fixation. Prior to transscleral fixation of the anchor 125, one (or all) of the plurality of fixation arms 120 may include a bent fixation arm 120 that bends between its starting portion 103 and its end portion 102 to form a bend B (see [link to relevant documentation]). Figures 22A-22B ), enabling at least a portion of the fixed arm 120, which allows visualization of the flexion through the pupil 30 of the eye (see Figure 13 Following the scleral fixation anchor 125, each of the plurality of fixation arms 120 can be tensioned between its starting portion and distal end to align the support structure with respect to the Z-plane of the eye. The support structure 105 is adapted to provide support for the intraocular lens. A central aperture 115 extending through the full thickness of the support structure 105 is adapted to allow light to pass through the central aperture 115 and the IOL supported by the support structure 105. The flexed fixation arms 120 can be flexed forward such that a portion of the arm 120, such as the distal end 102 and / or its non-invasive anchor 125, is positioned above at least a portion of the support structure 105 (e.g., above the upper surface of the support structure 105 and / or the region of the central aperture 115). Alternatively, (one or more) of the flexed fixation arms 120 can be flexed backward such that a portion of the arm 120, such as the distal end 102 and / or its non-invasive anchor 125, is positioned below at least a portion of the support structure 105 (e.g., below the lower surface of the support structure 105 and / or the region of the central aperture 115).

[0090] Figure 19A and Figure 20A An embodiment of the pre-implantation device is shown. Figure 19B-19C as well as Figure 20B-20CThe implanted device is shown. Two of the three fixed arms 120 are inwardly flexed such that they are biased toward a folded configuration when at rest. The arms 120 extend substantially orthogonally outward from the support structure 105, for example, from their origin 103 at the support structure 105 and turn (forward or backward), forming a flexure between the origin 103 and the end 102 of the arm 120. The flexure of the arm 120 may cause the end 102 of the arm 120 to be positioned closer to its own origin 103. In some embodiments, the arm 120 flexes in a forward direction such that the end 102 of the arm 120 is positioned in front of the origin 103 of the arm or above at least a portion of the forward surface of the support structure 105 near the origin 103 of the arm. In other embodiments, the arm 120 may flex in a backward direction such that the end 102 of the arm 120 is positioned behind the origin 103 of the arm or below at least a portion of the backward surface of the support structure 105 near the origin 103 of the arm. In one embodiment, the anchor 125 of the flexed fixation arm 120 can be flexed away from the first plane of the support structure (e.g., the Z-plane of the eye) into a second plane parallel to the first plane. The second plane can be before or after the first plane, depending on whether the arm 120 is flexed forward or backward. This flexion can be in a direction substantially transverse to (e.g., the X-plane) the plane of the lens support structure 105 (e.g., the Z-plane). The diameter of the enlarged pupil (depending on whether the patient is an adult or a child) can reach approximately 8 mm. This flexion positions the anchor 125 of the flexed fixation arm 120 within the diameter of a circle visible within the diameter of the enlarged pupil, positioned in the second plane, so as not to obstruct the visualization of the opaque iris, for example, between approximately 3 mm and approximately 7.5 mm, more preferably approximately 7 mm. Anchors 125 of each buckled retaining arm 120 may be positioned at a distance from the center of the device, for example, about 1.5 mm, 2.0 mm, 2.5 mm, 3.0 mm, up to no more than about 3.5 mm, or no more than about 4.0 mm from the center of the device. The buckled arms 120 are used to position the end portions 102 and / or anchors 125 within this diameter or at this distance from the center of the device to allow for easy visualization. The third of the three retaining arms 120 is biased in a straight or extended configuration at rest. The third arm 120 extends vertically outward from its origin 103 at the support structure 105 without turning or bending. Instead, the entire third arm 120 is completely straight and extends substantially along a single axis. The two retaining arms that are biased toward a folded configuration at rest are now in an extended configuration, for example, by tensioning the arms 120 via exposed transscleral anchors.

[0091] The fixed arms 120 can be evenly distributed around the device 100 to provide uniform tension. Alternatively, the fixed arms 120 can be oriented in a non-uniform distribution, for example, three fixed arms 120 at 90 degrees to each other. In this case, two of the fixed arms 120 will be at 180 degrees to each other, providing opposing tensions; while the third fixed arm 120 is mainly used to prevent the device 100 from rotating.

[0092] The lens support structure 105 can provide multiple functions. The lens support structure 105 may have surfaces forming a stable platform (anterior surface 1210 or posterior surface 1215) against which the IOL 110 can be placed during use. The lens support structure 105 can replace the capsular bag, especially a capsular bag that is ruptured or otherwise dysfunctional on the posterior and / or anterior sides. Its geometric and mechanical functions not only support the IOL 110 during use, but also help center the IOL 110 in cases of asymmetrical eyes or asymmetrical surgery. The lens support structure 105 can be coupled to one or more fixation arms 120. Where the lens support structure 105 provides artificial anterior capsular support for the IOL, the fixation arm 120 provides an artificial small band device. Thus, this device provides a stable platform structure fixed to the eye, reproducing the native anterior capsular and small band device that would typically allow placement of the IOL. The geometry and mechanical properties of the lens support structure 105 can be designed to allow the fixation arm 120 to function as intended and to withstand any torsional or tensile forces that may be applied by the fixation arm 120.

[0093] The fixation arm 120 and the lens support structure 105 are designed such that the properly fixed device 100 will position the central hole 115 in a manner that does not interfere with the patient's vision. The surgeon can place the IOL 110 through the lens support structure 105, thereby providing the patient with the refractive correction they require.

[0094] The ciliary body has a generally circular or elliptical shape, with its vertical axis being on average 0.5 mm longer than its transverse axis. The lens support structure 105 can engage with the patient's ciliary body to provide centering of the device 100 within the eye. The generally circular or elliptical lens support structure 105 can provide centering similarly to the circular or elliptical ciliary body. However, shape matching and 360-degree contact between the lens support structure 105 and the ciliary body can lead to inflammation or damage, which can negatively affect aqueous humor production. In a preferred embodiment, the lens support structure 105 has a continuous inner circumference and outer peripheral surface, the inner circumference forming a uniform, generally circular inner wall 109 defining a central aperture 115, and the outer peripheral surface forming a generally non-circular outer wall 111, providing a generally non-circular geometry for the lens support structure 105 (see [link to documentation]). Figure 1The non-circular external geometry of the lens support structure 105 provides centering of the device 100 without 360-degree contact with the ciliary body along its substantially non-circular outer peripheral surface. The shape of the lens support structure 105 provides sufficient contact between the lens support structure 105 and the ciliary body to aid in the centering and support of the IOL 110 without causing inflammation or damage. In some embodiments, the shape of the lens support structure 105 allows contact with the ciliary body at approximately 120 degrees or less, preferably between 1 and 45 degrees, or between 1 and 20 degrees. Limiting contact to 120 degrees or less can significantly reduce the risk of inflammation or damage to aqueous humor production. The substantially non-circular or elliptical shape of the lens support structure 105 allows for gentle contact between the device 100 and the ciliary body, providing centering without requiring a precise match to the patient's specific dimensions. The radius of curvature of the lens support structure 105 can be smaller than the radius of curvature of the ciliary process. Therefore, the lens support structure 105 can contact the ciliary process at three distinct points rather than within a calculable range. For example, when in use, the substantially non-circular outer peripheral surface of the lens support structure 105 can contact the ciliary process at three different points. In other embodiments, once each fixation arm 120 is implanted and placed under tension, the convex corner 107 of the device 100 is positioned near the ocular tissue (e.g., the ciliary body) but avoids contact with it. This arrangement allows the convex corner 107 to help center the device and prevent one arm 120 from being over-tensioned relative to the other. If a fixation arm 120 is pulled too far during the prominence of its anchor 125, an adjacent convex corner 107 on either side of that fixation arm 120 can abut against the ciliary body during implantation, thereby pushing the support structure 105 away from the ciliary body and prompting the device 100 to be more centrally aligned. Once implanted, the convex corner 107 of the device can be positioned near the ocular tissue (e.g., the ciliary body), with or without contact with the ocular tissue. The tensioned fixation arms 120 can be pulled substantially equally on the support structure 105 around its periphery. The tension applied around the support structure 105 allows the central axis CA of the device 100 extending through the central hole 115 to be substantially aligned with the visual axis of the eye, and allows the planar surface of the support structure 105 to be stabilized 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 (coincident) with the visual axis of the eye.

[0095] The non-circular outer wall 111 of the lens support structure 105 may include a plurality of convex corners 107 projecting outward (i.e., in a convex manner) from a plurality of generally flat or concave sides 108. This can form the outer wall 111 of the lens support structure 105 having an alternating pattern of convex corners and concave or flat sides. In a preferred embodiment, the lens support structure 105 may include three convex corners 107 or rounded corners projecting between three flat or slightly concave sides 108, thereby providing the lens support structure 105 with a triangular shape or a rounded triangular shape (see See [link to other embodiments]). Figure 1 The convex angle 107 can act as a buffer against the ciliary body 15 and / or ciliary sulcus 25 to provide anti-rotational function in the Z-plane and / or prevent displacement in the Z-plane to maintain proper alignment between the central aperture 115 and the visual axis of the eye (see [link]). Figure 4 Multiple fixation arms 120 may be positioned on the side 108, and multiple protrusions 107 project outward between the multiple fixation arms 120. Each fixation arm 120 may have a length longer than the distance by which the protrusions 107 project outward. As described above, the lens support structure 105 may have a circular inner wall 109 defining a central aperture 115. The multiple protrusions 107 projecting outward from the central aperture 115 provide varying thickness in the plane of the central aperture 115 between the inner wall 108 and the outer wall 111. The thickness of the lens support structure 105 at the location of the substantially flat side 108 between the inner wall 108 and the outer wall 111 is less than the thickness of the lens support structure at the location of the protrusions 107 between the inner wall 108 and the outer wall 111. The number of rounded convex angles 107 forming the lens support structure 105 can vary, thereby providing the lens support structure with any of a variety of non-circular shapes, including rounded triangles, rounded rectangles, rounded pentagons, rounded hexagons, trefoils, tetralobes, pentalobes, etc. The protrusions or angles of these non-circular geometries can be rounded to provide soft, non-penetrating contact with ciliary tissue, such as the ciliary body. Alternatively, the device 100 can be designed to utilize the ciliary body or scleral wall for assisted centering. In this embodiment, the device 100 can be positioned posterior to the ciliary process.

[0096] The plurality of convex angles 107 may include at least three convex angles, thereby providing a substantially rounded triangular shape for the lens support structure 105. A first count of the plurality of convex angles 107 may be equal to a second count of at least three fixation arms 120, wherein each of the convex angles 107 is spaced apart from adjacent fixation arms 120. Between adjacent fixation arms, the convex angles 107 may be symmetrically spaced around the outer periphery of the lens support structure. Between adjacent convex angles 107, each of the at least three fixation arms 120 may be symmetrically spaced around the outer periphery of the lens support structure 105.

[0097] Each fixation arm 120 may have a spring force that is a function of the elongation of the material under load. In contrast, an open-loop haptic or coil spring may have a spring force provided by the bending of a material with a substantially fixed length. Once anchored in the eye, the fixation arms 120 can withstand tensile stress and material elongation. For example, each fixation arm 120 may provide an extension in a radius between approximately 7.5 mm and 8.0 mm to accommodate diameters between approximately 15 mm and approximately 16 mm. The device has an operable range of functional tension. As an example, the device can be placed under a first tension force (X tension) once implanted. The first tension force is the tension force within the minimum acceptable diameter. In other words, the device is under a minimum amount of tension to function, but can be placed under greater tension to accommodate larger diameters. In the example of fixation arms 120 capable of accommodating 15 mm and 16 mm extensions, each force-transmitting arm can operate under a first tension X and at least a second tension. The second tension may be the sum of the first tension X and a tension distance (e.g., 0.5 mm tension). The fixation arms can withstand different tensions available at each elongation rate. To further illustrate this example, if each fixation arm 120 in this embodiment is approximately 4 mm long, the second tension (X tension + 0.5 mm tension) can withstand a 12.5% ​​increase in elongation to function at a diameter of 15 mm, and also function up to a diameter of 16 mm. If the fixation arm 120 in this example is 2 mm long, the second tension (X tension + 0.5 mm tension) can withstand a 25% increase in elongation to function at a diameter of 15 mm, and also function up to a diameter of 16 mm. If the fixation arm in this embodiment is approximately 6 mm long, the second tension (X tension + 0.5 mm tension) can withstand a 6.25% increase in elongation to function at a diameter of 15 mm, and also function up to a diameter of 16 mm. The reduced spring force of the fixation arms 120 enhances the safety and functionality of the device because the tension of the anchors on the ocular tissue is less dependent on variables that are difficult for surgeons to assess—the inherent size of the eye and the location of the incision. In addition, the length of the fixation arms (e.g., between about 2 mm and 6 mm) and the inward flexion (forward or backward) of at least one or more fixation arms 120 improve the surgeon's ability to locate and visualize the fixation arms during the procedure.

[0098] With one, two, or three fixation arms 120 engaged, the IOL 110 can pass between the device 100 and the ciliary process. The lens support structure 105, designed to contact or nearly contact the ciliary body, also reduces the risk of the IOL 110 being lost into the posterior chamber during surgery.

[0099] The lens support structure 105 can be configured to allow a surgeon to implant the IOL 110 to be supported by the device 100 using an "optical capture" technique. In this technique, the optics 112 of the IOL 110 partially or completely pass through the central aperture 115 of the device 100, while the tactile element 114 of the IOL 110 remains substantially in front of the device 100 (see [link to documentation]). Figure 3 This technique provides a secure fixation of the IOL 110, preventing it from drifting along the X, Y, or Z axes post-operatively and reducing the volume of space in front of the lens. It also allows for the safe use of a "square-edge" IOL design by reducing contact between the IOL and the posterior surface of the iris 10. Surgeons gain increased flexibility in modifying the IOL power by providing a choice of effective lens placement. The technique also allows for the use of astigmatic correction IOLs by restricting IOL rotation. In some cases, the space between the anterior surface of the lens support structure 105 and the posterior surface of the iris 10 may be limited. To reduce the risk of iris injury or pupillary obstruction, it is advantageous to fix the IOL 110 in or behind the plane of the lens support structure 105. Furthermore, fixing the optics simultaneously enhances the predictability of its refractive position, allowing for more accurate preoperative lens selection calculations.

[0100] To facilitate the use of optical capture technology, the lens support structure 105 allows the surgeon to pass the IOL 110 through the aperture 115 of the device 100. The diameter of the aperture 115 can be similar to that of a typical IOL, for example, at least 5.5 mm or 6.0 mm. In this case, the surgeon can pass the IOL 110 through the aperture 115 by applying a force parallel to the optical axis or by slightly tilting the IOL 110 to slowly move it through the aperture 115. The inner diameter of the aperture 115 can be greater than or less than 5 mm, for example, 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 any value in between.

[0101] Alternatively, device 100 may incorporate a feature that allows the diameter of orifice 115 to be temporarily enlarged to allow IOL 110 to pass through orifice 115. Support 105 may have an outer peripheral wall and an inner peripheral wall that are discontinuous, such that support structure 105 forms an open ring with a gap between the ends of the ring. In this embodiment, the inner diameter of orifice 115 may vary depending on whether the ends of the ring are compressed or separated towards each other. In another embodiment, the outer peripheral wall may be a complete annulus or continuous circumference, and the inner peripheral wall defining orifice 115 may be discontinuous or continuous. A single orifice may have a continuous inner circumference without any gaps, grooves, or channels. Alternatively, a single orifice may have a discontinuous inner circumference. Figure 5An embodiment of device 100 is shown, having one or more slits 113 formed in the inner wall 109 defining an aperture 115. Device 100 may include more than a single slit 113, for example, 2 to 40 slits 113 circumferentially located around the aperture 115 in the inner wall 109. The slits 113 may preferably have a length sufficient to extend radially outward from the inner diameter of the aperture 115 by 0.25 mm to 2.0 mm, thereby increasing the flexibility of the support structure 105. IOL 110 may pass through the flexible lens support structure 105. Alternatively, device 100 may incorporate one or more deflectable flaps 116 molded into the lens support structure 105 (see...). Figure 6 The device 100 may include more than a single deflectable flap 116, for example, 2 to 40 flaps 116, which deflect under sufficient force applied by a surgeon and allow the IOL 110 to pass through the aperture 115. Alternatively, the inner wall 109 may have a brush-like structure that deflects under sufficient force applied by a surgeon and allows the IOL 110 to pass through. In a further embodiment, the cross-sectional thickness profile of the lens support structure 105 may taper toward the aperture 115. The outer periphery of the lens support structure 105 near the outer wall 111 will have a greater thickness than the inner periphery of the lens support structure 105 near the inner wall 109 (e.g., thickness measured anteroposteriorly when the device is positioned in the eye). Therefore, the central portion of the lens support structure 105 (i.e., the inner wall 109) will have greater flexibility due to the reduced thickness, allowing the IOL 110 to pass through the aperture 115 and deflecting the inner wall 109 when placed under sufficient force. Although the lens support structure 105 has greater flexibility near the inner wall 109, whether due to the slit 113, the flap 116, or the reduced thickness, the lens support structure 105 has sufficient strength to support the IOL 110 resting on the anterior surface of the lens support 105 or the IOL partially or completely behind the lens support 105.

[0102] Figure 7A and Figure 7BVarious fixation arms 120 are shown, each having an end plate or anchor 125. The anchor 125 may be attached to or positioned at the outer end of the fixation arm 120. These geometries are designed to be easily visualized by the surgeon and to stabilize tension on the device throughout its service life. The anchor 125 may have a generally low profile and may have a geometry designed to limit conjunctival erosion and eyelid irritation (e.g., rounded). The end of the fixation arm 120 may have an anchor 125 configured to be positioned outside the sclera 20 to secure the lens support structure 105 and prevent centripetal slippage. The geometry of the anchor 125 allows the surgeon to pass the anchor 125 through a perforation or incision in the sclera 20 using forceps, cannulas, or other surgical instruments. A snare device for anchor retrieval is described in more detail below. The geometry of the anchor 125 can resemble a nail head, a T-bar, a multi-pronged shape, or any other geometry that preferentially passes over the sclera 20 in the first direction and resists pull-out insertion, in order to maintain its external position under the expected tension during the entire lifespan of the device. The anchor 125 is designed to have a profile and geometry that will not irritate the eyelids or conjunctiva during the entire lifespan of the device 100. Therefore, a preferred geometry will have a minimum thickness profile with smooth, rounded, and / or tapered edges. The anchor 125 may have a substantially constant thickness or may have a thickness that varies along its length, as discussed in more detail below.

[0103] The anchor 125 described herein is configured to be both easily exposed and resistant to re-internalization after exposure. The anchor can be designed to be gripped using ophthalmic tools (e.g., gauges 23, 25, or 27). An ideal geometry for gripping with ophthalmic tools may not necessarily be ideal for secure fixation. Figures 8A-8CAdditional geometry of the anchor 125 with variations in thickness, width, and / or height is shown. The anchor 125 may include a central portion 1255 and one or more gripping portions 1257 surrounding the central portion. The central portion 1255 may be arranged over the wound (sclerotomy) through which the anchor 125 is inserted, and the gripping portions 1257 are arranged immediately adjacent to the wound. Compared to the peripheral gripping portions 1257, the central portion 1255 may have increased thickness, height, and / or width. The increased thickness, height, and / or width of the central portion 1255 may increase the volume of the area above the wound, thereby reducing the likelihood that tension on the fixation arm will pull the anchor 125 back through the wound. The thickness Tc of the central portion 1255 of the anchor 125 along the longitudinal axis L of the arm 120 may be greater than the thickness Tg of the gripping portions 1257. For example, the thickness Tc may be approximately 1.2 to 5.0 times the thickness Tg of the gripping portions 1257. In other embodiments, the width or height of the central portion 1255 may be approximately 1.2 to 5.0 times the width or height of the grippable portion 1257. The geometry of the larger volume region is designed to resist deformation under tensile forces associated with normal use of the device. The larger central portion 1255 can collapse inward to fold onto the end of the arm 120 to which it is attached during exposure. Once the arm 120 is placed under tension, the larger central portion 1255 cannot fold away from the end of the arm 120 onto itself, preventing the exposed anchor 125 from being pulled back through the wound. Thus, the central portion 1255 can be pulled across the wound in a first direction (outward from the eye), but due to its larger volume, it is prevented from being pulled across the wound in a second, opposite direction (inward toward the eye).

[0104] The gripping portion 1257 may include any of a variety of shapes, including oval, rectangular, star-shaped, or other shapes or geometries that improve the gripping ability of the gripping portion 1257 compared to, for example, the central portion 1255. The gripping portion 1257 may have a thinned and narrow tab extending from the central portion 1255. Each anchor 125 may include 1, 2, 3, 4, 5, 6, or more gripping portions 1257 to allow a user to grip the anchor regardless of the device's construction.

[0105] In some implementations, each fixed arm 120 may have more than one anchor 125. Figure 9An embodiment of the device 100 with three fixation arms 120 is shown, each fixation arm having a first anchor 125a at its end and a second anchor 125b positioned inside the first anchor 125a. The second anchor 125b can further secure the lens support structure 105 by preventing centrifugal slippage. Alternatively, the second anchor 125b can be exposed through the sclera 20, such that the second anchor 125b also holds the device 100 in place. In this case, the surgeon can choose to trim any material of the fixation arms 120 positioned around the second anchor 125b (e.g., the first anchor 125a). This multi-anchor system allows the surgeon to adjust the size of the device 100 intraoperatively according to the patient's eye. Each fixation arm 120 may include a plurality of anchors 125 that can be positioned along the length of the fixation arm 120. The plurality of anchors 125 may include 2, 3, 4, 5 or more anchors 125 evenly spaced along their length. Because the fixation arm 120 is exposed through the sclera, its length can be "customized" according to the number of anchors 125 that are also exposed. The surgeon can expose the required number of anchors 125 to center the device 100. Excess material around the outer anchors 125 closest to the sclera 20 can be removed, for example, by trimming. Figure 9 Two anchors 125a and 125b are shown with different external dimensions, wherein the inner anchor 125b is narrower than the outermost anchor 125a. It should be understood that multiple anchors 125 can also have the same dimensions and do not need to vary in size. Anchors 125 can also have geometries that improve their transmission through the sclera in a first direction but weaken their transmission through the sclera in a second, opposite direction. For example, Figure 9 The square edge of anchor 125 is shown. However, anchor 125 may have a square edge on the inward-facing surface and a smooth tapered edge on the outward-facing surface, which facilitates its transmission in the outward direction.

[0106] The fixation arms 120 extending to the eye wall may be difficult to manipulate because they may be obstructed by the peripheral iris 10, limbus, and sclera 20. As described above, one or more of the fixation arms 120 may be biased inward toward a folded configuration. Each fixation arm 120 may initially extend vertically outward from the support structure 105 and then bend or fold forward (or backward) such that the end of the fixation arm 120 is positioned above at least a portion of the fixation arm 120, the support structure 105, or the central aperture 115 extending through the support structure 105. At least a portion of the bent fixation arm (i.e., the end and / or anchor 125) can be more easily visualized through the dilated pupil and visualization is not obstructed by the opaque iris 10 (see [link to relevant documentation]). Figure 13This inward (centripetal) bias also allows the bent retaining arms 120 to be safely gripped and manipulated during device implantation. Each of the retaining arms 120 of the device 100 may have an inward bias toward a folded configuration, or only a portion of the retaining arms 120 may have an inward bias (e.g., one, two, up to fewer than all of the retaining arms 120).

[0107] The device 100 can be manufactured without inward bias and can be manually manipulated to set inward bias. This manipulation can be performed by the manufacturer or a surgeon. The purpose of this manipulation is to temporarily position at least a portion of the fixation arms 120 so that they are easily visualized through a dilated pupil during implantation. The manipulation may involve 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 can be removed. The structure of the device 100 may incorporate (or include) one or more features that allow the fixation arms 120 to temporarily engage the lens support structure 105 in a manner that facilitates visualization of the fixation arms 120. For example, Figure 9 The inner wall 109 defining the central aperture 115 may include one or more notches 117 for temporarily holding the fixation arm 120 in an inwardly biased position. Each notch 117 is complementary in shape to the fixation arm 120, so that it can receive at least a portion of the fixation arm(s) 120 within the notch 117. The manufacturer or surgeon may fold, twist, or otherwise manipulate the fixation arm 120 into the notch 117. After insertion into the eye, the surgeon may disengage the fixation arm 120 from the notch 117 and continue to expose the fixation arm 120 through the sclera. The notch 117 in… Figure 9 The notch 117 is shown on the inner diameter or inner wall 109. However, the notch 117 may be located on another surface of the device 100, including the peripheral surface (e.g., outer wall 111), front surface, or rear surface of the lens support structure 105.

[0108] The fixation arm 120 can also be molded to incorporate a bend or flexure between its origin and end anchors 125 of the lens support structure 105 (see [link]). Figure 10-12 , Figure 17B-17E , Figure 19A , 20A 21A-B, 22A-22B, 23A-23B, 24A-24F, 25A-25C, 26A-26E and Figure 27One or more of the bent fixation arms 120 may be biased toward a folded configuration. For example, one or more of the fixation arms 120 may be bent between 90 and 270 degrees in the radial and centripetal directions from their origin with respect to the lens support structure 105. Thus, the ends of the bent fixation arms 120 lie in a plane different from the plane of the lens support structure 105. When in a resting state before being positioned in the eye, the ends of at least the first fixation arm 120 of the plurality of fixation arms 120 may combine a bend between its origin with respect to the lens support structure and its end, thereby forming a bent arm. The bent arm may extend perpendicularly to the lens support structure 105 from its origin by at least a first distance. The bent arm may then bend upward (forward) away from the plane of the lens support structure 105 by at least another distance. The bent arm 120 may then bend back toward its origin or toward the central axis CA of the device. This results in the ends of the bent arm 120 lying in a plane different from the plane of the lens support structure 105. The flexed or bent portion of the arm 120 may project outwards away from the central axis CA and away from the arm's origin 103 and end 102. The distal portion of the flexed arm 120 may be positioned above or in front of at least a portion of the lens support structure 105, or above at least a portion of the central aperture 115. Alternatively, one or more flexed arms 120 may be flexed downwards (rearwards) away from the plane of the lens support structure 105 by at least a certain distance, and the distal portion of the flexed arm 120 may be positioned below or behind at least a portion of the lens support structure 105 and / or below or behind at least a portion of the central aperture 115. The folded configuration (whether the arm 120 is flexed forwards or backwards) allows at least a portion of the flexed fixed arm 120, such as the distal end of the flexed fixed arm 120 and / or its anchor 125, to be visualized through the pupil and unobstructed by the opaque iris. Only one arm 120, two arms 120, or all of the fixed arms 120 may be combined with the buckling portion.

[0109] Once the device is positioned and anchored in the eye, the fixing arm 120 is placed under tension, causing the bent arm to unfold from the folded configuration and no longer bend. The end of the arm 120 is pushed away from the resting state of the folded configuration to push the bent fixing arm into the straight or unfolded configuration.

[0110] The bend in the folded configuration can be a gradually changing, smooth bend with a radius of curvature, or it can be bent to form one or more different angles along the length of the arm 120. The bend can be tight enough to avoid protruding far forward, while still being able to stretch or be positioned relatively easily in an unfolded configuration without exerting excessive stress on the lens support structure 105. The inwardly biased geometry can have a bend with a radius of curvature between about 0.10 mm and about 2.5 mm on the inner bend (anterior side) and a bend with a radius of curvature between about 0.6 mm and about 3.0 mm on the outer bend (posterior side). In an embodiment, the end of the inwardly biased fixation arm can be spaced apart from the lens support structure 105 to form a gap G (see...). Figure 17B The gap G can be between approximately 0.2 mm and approximately 2.5 mm. In one embodiment, the biased fixation arm 120 bends 180 degrees with a full radius and has an inwardly biased geometry, with a radius of curvature of approximately 0.63 mm on the inner bend and approximately 1.13 mm on the outer bend, such that the lens support structure 105 and the biased fixation arm are spaced approximately 1.25 mm apart. The starting point of the bend (near the starting point 103 of the lens support structure 105) and the ending point of the bend (near the end point 102 at the scleral anchor 125) can have multiple radii, such that the bend varies along the length of the fixation arm 120. The bend of the biased fixation arm 120 can have an average curvature between approximately 0.15 mm and approximately 2 mm on the inner bend.

[0111] The curved fixation arm 120, after implantation and before fixation to the scleral wall, is visible through the pupil in a stress-free (resting) state (see [link]). Figure 13 This visibility allows the surgeon to easily engage the anchor 125. When engaging the fixation arm 120 by grasping the body of the fixation arm 120 or the anchor 125, the surgeon can unfold the fixation arm 120 from its resting folded configuration so that it is substantially coplanar with the lens support structure 105. These fixation arms 120 can be flexible such that the stress stored in the material in the deployed state will not exert torsional or tensile forces on the lens support structure 105 in a manner that would impair the function of the device. One or more fixation arms 120 can be molded to have turns of 90-270 degrees in both the tangential and centripetal directions from the origin of their lens support (see [link]). Figures 23A-23B One or more fixation arms 120 may incorporate a resilient material or deformable hinge to facilitate this manipulation without significantly altering the geometry of the lens support structure 105. The length of the fixation arms 120 is such that when the fixation arms 120 are bent 180 degrees rearward toward their origin in relation to the lens support structure 105, the end 102 of the fixation arms 120 can be positioned above at least a portion of the lens support structure 105, such as... Figure 10-11 As shown. Each of the fixing arms 120 of the device 100 may have a bend, or only a portion of the fixing arms 120 may have a bend (e.g., one, two, up to less than all of the fixing arms 120). Figure 10-11 Two of the fixation arms 120 have curved portions, and one fixation arm is substantially coplanar with the plane of the lens support structure 105.

[0112] One or more of the fixation arms 120 of the device described herein may be manufactured to have a non-planar geometry in a resting state and may be biased toward a folded configuration that allows at least a portion of the fixation arm 120 to be easily viewed through the pupil 120 once the device 100 is implanted but before the anchor 125 is exposed. A fixation arm 120 with this configuration can be more easily grasped and manipulated by a user, allowing it to be pushed into an unfolded configuration for seamless fixation. Fixation arms 120 manufactured to have a bias in a resting state or to be flexed or bent in a resting state include fixation arms 120 having this shape when the device 100 is outside the eye and ready for implantation. In some embodiments, the fixation arm 120 may be in a flexed, folded, or bent shape after implantation into the eye (e.g., the posterior chamber) but before anchor fixation. For example, one or more fixation arms 120 may be formed of a material that has a first shape outside the eye, presents a flexed shape different from the shape of the arm 120 before implantation into the eye, and can unfold into a substantially straight shape when the anchor 125 is exposed.

[0113] A fixation arm 120 having an offset toward a folded or flexed shape (e.g., having a bend along its length between its starting portion 103 and its ending portion 102) can be visualized, grasped, and manually unfolded and / or extended via (or through) the pupil to transscleral fix the anchor 125 of the arm 120. The configuration and / or radius of curvature of the flexion, bend, or fold, as well as the orientation of the flexion, bend, or fold, can vary, as long as at least a portion of the fixation arm 120 (e.g., the anchor 125 and / or the end portion attached to the anchor 125) is visible to the user through the diameter of the patient's pupil, preferably through the patient's dilated pupil. In some embodiments, this means that at least a portion of the fixation arm 120 is positioned above at least a portion of the lens support structure 105 and radially inward from its outer wall 111. The distance by which this portion of the arm 120 extends radially inward from the outer wall 111 can vary. This portion may extend above the outer wall 111 at a position not above the outer wall 111 in the orientation of the central axis CA extending from front to back through the central opening 115. In this embodiment, the distance between the central axis CA of the device and the portion extending above is greater than the distance between the central axis CA of the device and the outer wall 111. This portion may extend above the outer wall 111. In this embodiment, the distance between the central axis CA of the device and this portion is the same as the distance between the central axis CA of the device and the outer wall 111. This portion may extend above the outer wall 111 at a position radially inward. In this embodiment, the distance between the central axis CA of the device and this portion is less than the distance between the central axis CA of the device and the outer wall 111. This portion may extend above the central opening 115. In this embodiment, the distance between the central axis CA of the device and this portion is less than the distance between the central axis CA of the device and the inner wall 109 defining the central opening 115.

[0114] A portion of the fixation arm (e.g., the end and / or anchor 125) may be positioned over a portion of the lens support structure 105 and also over a portion of the central opening 115. For example, the anchor 125 may be sized 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.

[0115] The fixation arm 120 biased towards a flexure configuration may flex towards the interior 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 a circle formed by a central aperture 115 (in the case that the central aperture 115 is circular). The central axis CA of the device extends through the center of this circle in the anteroposterior direction (i.e., the vertical direction). If the central aperture 115 is substantially non-circular, the center of the device is the center of symmetry of the central axis CA extending along the anteroposterior direction from the central aperture 115. Fixation arms biased into a folded or flexed configuration with their anchors extending towards the center of the device or the central axis CA of the device do not need to intersect the actual center or the central axis CA of the device through the axis of the arm's anchors. "Towards the center" or "towards the central axis" for an inwardly biased fixation arm includes an arm with a flexure such that the end of the fixation arm extends back toward a portion of the device in a generally inward direction, unlike the end of a straight fixation arm, which extends away from the lens support structure in a generally outward direction. The buckled fixed arm can be biased toward any central part of the device and does not need to be directly pointed to the actual center of the device. The buckled fixed arm can be angled relative to the actual center.

[0116] Figures 22A-22B and Figures 23A-23B An embodiment of the device is shown, wherein at least some of the fixed arms extend backward toward the center of the device. Figure 22A A device 100 with a lens support structure 105 and three fixation arms 120 is shown. Two fixation arms 120a, 120b are biased into a folded configuration, wherein a bend B exists between the arm's origin 103 and its end 102. The third fixation arm 120c is substantially straight and has no bend B between its origin 103 and its end 102, such that it extends substantially perpendicularly to the lens support structure 105 along a single axis. Anchors 125 of the corresponding fixation arms 120a, 120b project back toward the center of the device. The anchors 125 of the fixation arms 120a, 120b have at least a first portion overlapping at least a portion of the lens support structure 105 and / or at least a second portion overlapping at least a portion of the central opening 115 (see [link to documentation]). Figure 22A The axes can be drawn using the anchors 125 of each arm 120a, 120b, showing the bend B of the anchor 125 away from the start point 103 and end point 102 of the arm and protruding towards the center of the device. Axes L1 and L2 do not intersect the central axis CA. Figure 22BA similar device 100 is shown with two fixed arms 120a, 120b, which are biased into a folded configuration. Each arm has a bend B between the starting point 103 and the end point 102 of the arm 120a, 120b. Anchors 125 of the corresponding fixed arms 120a, 120b extend back toward the center of the device. Axes L1 and L2 intersect the central axis CA. Therefore, the arms can be biased toward a folded configuration, wherein the anchors protrude back toward the center of the device, but do not need to extend along an axis intersecting the central axis CA or the actual center of the device.

[0117] When the fixation arm is described as "folded," "bent," or "flexed," or has a configuration of "folded," "bent," or "flexed," the angle of the fixation arm relative to its longitudinal axis along its length can vary gradually and uniformly, or it can vary more abruptly or suddenly to form an angle. A folded configuration can describe an inward bias of the lead fixation arm at rest or during implantation, wherein the fixation arm extends outward from the support structure along a first axis and flexes forward or backward relative to the plane of the support structure toward the central portion of the device. During implantation, the support structure of the device is configured substantially parallel to the Z-plane (vertical plane) of the eye. A folded configuration may include a geometry in which the fixation arm flexes away from this plane of the support structure (e.g., in a transverse plane) (such as...). Figures 22A-22B As shown), at least a portion of the fixation arm is positioned in front of another portion of the device (e.g., above itself, the lens support structure, and / or the central opening). The folding configuration does not necessarily mean that the portions of the fixation arm overlap and also contact each other. Preferably, the portions of the fixation arm are spaced apart by a distance along the central axis CA of the device. The folding configuration also does not necessarily mean a crease or an acute angle. A folding configuration can mean that there is a radius of curvature between the starting point of the fixation arm at the support structure and the end point of the fixation arm.

[0118] The folding configuration may also include a fixation arm that flexes within the plane of the lens support structure rather than away from the plane of the lens support structure. Figures 23A-23B Another embodiment of the device 100 having a lens support structure 105 and three fixation arms 120 is shown. Two fixation arms 120a, 120b are biased into a folded configuration, wherein a bend B exists between the arm's origin 103 and its end 102. The third fixation arm 120c is substantially straight and has no bend B between its origin 103 and its end 102, such that it extends substantially perpendicularly along its axis relative to the lens support structure 105. Anchors 125 of the straight fixation arm 120c project outwardly along the arm's axis away from the center of the device. In contrast, anchors 125 of the corresponding fixation arms 120a, 120b project inwardly from the bend B of the arm. The anchors 125 are substantially held in the same plane as the plane of the lens support structure (see [reference]). Figure 23B An axis can be drawn through the anchor 125 of each bent arm 120a, 120b, showing the direction in which the anchor 125 protrudes from the bend B between the arm's starting point 103 and the arm's end 102 and towards the center of the device. Fixed arms 120a, 120b, biased towards a folded configuration, have anchors 125 protruding towards the center of the device. Axes L1 and L2 may, but need not, intersect the central axis CA. Figure 23A The axes L1 and L2 shown extend toward the center but do not intersect the central axis CA.

[0119] A portion of the arm 120 positioned above at least a portion of the support structure 105 may include a portion located above and radially inward of the outer wall 110 of the support structure 105. This portion of the arm 120 positioned above at least a portion of the support structure 105 may include a portion positioned above and radially inward of the central opening 115. In these cases, "radially inward" does not necessarily mean in the same plane. Preferably, this portion of the arm 120 is positioned above the portion of the support structure in a plane different from the plane of the support structure. This portion of the fixing arm 120 (e.g., anchor 125 and / or end 102) may terminate in front of or behind the lens support structure 105 at a diameter centered on the outer periphery of the lens support structure 105. This portion may be located above the portion of the lens support structure relative to the central axis CA of the means extending forward and backward through the central opening 115. In the case where this portion of the fixation arm 120 is described as being above this portion of the lens support structure, this portion of the fixation arm 120 may also be above the central opening 115 defined by the lens support structure 105.

[0120] When a portion of arm 120 is described herein as being “above” another portion of device 100 (e.g., itself, lens support structure 105, and / or central opening 115), that portion of arm 120 may generally overlap spatially with that portion of the device and does not require a specific orientation relative to the retina. Thus, “above” may generally be used herein to refer to an overlap in space surrounding the device, and may, but is not required, to be in a generally forward direction relative to the retina. A portion described as being “above” another portion may be positioned posterior to it relative to the retina during use. An arm 120 biased into a folded configuration may herein only be referred to as being “above” or “overlapping” another portion of the device, even if it may be positioned “below” or “posterior” to the retina relative to the other portion of the device during use. For simplicity, each alternative may not be repeated in each example throughout the disclosure. The arm may be flexed to position at least a portion of the arm above the forward portion of the device such that the portion is generally arched above the device along the central axis CA. The arm can be flexed to position at least a portion of the arm above the rearward portion of the device, such that this portion is generally arched below the device along the central axis CA. The arm can be flexed to position at least a portion of the arm in a coplanar plane, such that it is neither above the forward nor the rearward portion of the device. Various configurations of the fixed arm are considered herein, such that at least a portion of the arm is visible through a dilated pupil. The mechanism can be varied, thereby allowing the bent fixed arm 120, biased towards a folding configuration, to unfold to present a straight configuration. The arm can be unfolded mechanically, electromagnetically, and / or thermally.

[0121] In some embodiments, the fixation arm 120 can be mechanically deployed along a single axis of the arm. The resting fixation arm 120 does not need to be biased into a folded configuration with bends or flexions. For example, the fixation arm 120 can be biased into a folded configuration in which the arm 120 is longitudinally compressed along a single axis. The arm 120 extends vertically outward from the lens support structure along a single axis between its starting portion 103 and its ending portion 102. The length of the arm 120 in the folded configuration can be shorter between the starting portion 103 and the ending portion 102, such that the anchor 125 of the arm 120 is more centrally positioned within a smaller diameter than when in the deployed configuration. Once the device is implanted in the eye, but before the anchor 125 becomes visible, the arm 120 can be telescoped outward to extend its length, thereby making it visible. The mechanical deployment by telescoping can be due to the nested components of the arm 120 sliding over each other to provide a greater length when deployed or a shorter length when folded. Mechanical unfolding via telescoping can also be due to a single elastic component configured to fold into itself to obtain a shorter length for visualization through the pupil and unfold from itself during display to obtain a longer length.

[0122] In some embodiments, the fixing arm 120 can be thermally unfolded or folded. For example, the fixing arm 120 can be in a first shape (folded or straight) at room temperature and change to a second shape at or near body temperature (heated to 35°C). This can also be achieved by chemical means (e.g., hydration) or mechanical means (cutting restrictive features).

[0123] The fixation arm 120 can be made of elastic or inelastic materials. For example, the fixation arm 120 can be formed of an inelastic material and have a 3D shape that provides elasticity. This 3D shape can vary as described elsewhere herein, including C-shape, Z-shape, S-shape, or other 3D shapes. The fixation arm 120 provides sufficient support to hold the IOL 110 or other device without applying excessive force to the scleral tissue. The optimal design will have a wide range of tension and stability operability to meet both parameters of incisions of different sizes and locations in the eye. One way to modify the fixation arm design is to incorporate spring-like structures. These can include conventional compression-based tactile designs such as J-loops, C-loops, closed loops, Kellman haptics, plate haptics, or other tactile designs common to IOLs. Alternatively, the device 100 can incorporate tension-based tactile elements, such as simple linear elastic cords. Alternatively, the tension design can be modified to have V-shaped, Z-shaped, or S-shaped features to reduce the tensile strength of the fixation arm 120.

[0124] The fixation arm 120 may have a texture or feature that allows it to be pulled across the sclera in one direction, but provides resistance in the opposite direction to minimize the possibility of slippage. This texture or feature may be provided by the material itself or designed into the fixation arm 120. For example, the fixation arm 120 may be barbed and formed from a material integrated into an external structure. In this way, the barbed internal structure can function as barbs while concealing the sharp edges typically associated with barbs. An example is a rigid plastic structure embedded in a soft elastomer structure.

[0125] The fixed arm 120 may be formed of a flexible material with memory and non-stretchability. The flexible material of the fixed arm 120 may include any of a variety of elastomers, including polyurethane, hydrophobic acrylic resin, hydrophilic acrylic resin, nylon, polyimide, PVDF, natural polyisoprene, cis-1,4-polyisoprene natural rubber (NR), trans-1,4-polyisoprene gutta-percha, synthetic polyisoprene (isoprene rubber is IR), polybutadiene (butadiene rubber is BR), chloroprene rubber (CR), polychloroprene, Neoprene, Baypren, etc., butyl rubber (a copolymer of isobutylene and isoprene, IIR), halogenated butyl rubber (chlorobutyl rubber: CIIR, brominated butyl rubber: BIIR), styrene-butadiene rubber (a copolymer of styrene and butadiene, SBR), and acrylonitrile rubber (a copolymer of butadiene and acrylonitrile, NBR) (also known as Bona). N-type rubber, hydrogenated nitrile butadiene rubber (HNBR), Therban and Zetpol, EPM (ethylene propylene rubber, a copolymer of ethylene and propylene) and EPDM rubber (ethylene propylene diene rubber, a terpolymer of ethylene, propylene and diene components), epichlorohydrin rubber (ECO), polyacrylic rubber (ACM, ABR), silicone rubber (SI, Q, VMQ), fluorosilicone rubber (FVMQ), fluororubber (FKM and FEPM), Viton, Tecnoflon, Fluorel, Aflas and Dai-El, perfluorinated elastomer (FFKM), Tecnoflon PFR, Kalrez, Chemraz, Perlast, polyether block amide (PEBA), chlorosulfonated polyethylene (CSM), (Hypalon), ethylene-vinyl acetate (EVA), thermoplastic elastomers (TPE), resins and elastomeric materials, polysulfide rubber and Elastolefin.

[0126] Arm 120, made of a flexible material that forms the shape, can flex away from the formed shape but has the memory to return to the formed shape. In other words, the flexible fixing arm 120 can flex or unfold away from its folded configuration, but cannot be pushed into a different shape that is held in place without some kind of anchoring. For example, one or more of the flexible fixing arms 120 can be formed into a curved shape. For example, an arm may include a 180-degree bend from its starting point 103 with the support structure 105 to its end point 102 near the anchor 125. When the device is at rest and no force is applied to the arm 120, the arm 120 can maintain this curved shape such that the arm 120 is biased toward the folded configuration. In other words, the arm 120 in its unbiased state is curved. The curved fixing arm 120 can flex away from this curved shape to present a straight shape or an unfolded configuration such that the entire arm 120 extends and is positioned straight relative to the longitudinal axis L. When flexed into a straight shape, the arm 120 is biased to return to the curved shape or folded configuration. If the flexural force on the fixed arm 120 is released, the fixed arm 120 will return to its resting bent shape. However, in use, the fixed arm 120 is anchored via the sclera and the anchor 125 at the end 102 of the arm 120 is positioned outside the sclera. The arm 120 is tensioned to maintain a straight shape.

[0127] In other embodiments, the fixation arm 120 may be formed of or combined with a stretchable material, such that the fixation arm 120 can be bent or shaped into a specific form. The stretchable fixation arm 120 may 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.

[0128] One or more retaining arms 120 may have a Young's modulus of less than about 1000 MPa, or less than about 500 MPa, or less than about 250 MPa, or less than about 100 MPa, or less than about 50 MPa, or less than about 25 MPa. One or more retaining arms 120 may have a Young's modulus of less than about 20 MPa, for example, between about 0.01 and about 1.0 MPa. The retaining arms 120 may be very flexible and apply very small forces because they are designed to anchor the support structure 105 under tension rather than with spring force to anchor the support structure 105 or with greater rigidity penetration force than barbs or other retaining tactile features can provide.

[0129] In some embodiments, each of the fixation arms 120 may have a length of approximately 2 mm to approximately 6 mm between the starting point 103 and the ending point 102. Each fixation arm 120 may have the same length. The length of the fixation arm 120 extending through the sclera may have a minimized thickness or width to reduce the overall size of the wound through which the arm 120 extends. The maximum width of the transscleral portion of the fixation arm near the ending point 120 where the anchor 125 is positioned may not exceed approximately 2.0 mm, approximately 1.5 mm, approximately 1.0 mm, 0.75 mm, or 0.50 mm.

[0130] Figure 12 An embodiment of device 100 is also shown, which has two inwardly biased fixed arms 120a and 120b and a straight third fixed arm 120c without inward bias. Furthermore, the third fixed arm 120c has a geometry that makes it less flexible than the other fixed arms 120a and 120b. The third fixed arm 120c may incorporate a region between its starting point 103 and its ending point 102, which is wider and may have a larger cross-sectional area than the other two fixed arms 120a and 120b. Figure 8B A wider area of ​​the fixed arm 120 is also shown. The width W1 of the arm 120 near the end 102 can be smaller than the width W2 of the arm 120 away from the end 102. The width W2 of the arm 120 away from the end 102 can provide a degree of volume and stability, while the width W1 near the end 102 can minimize the transscleral portion of the arm 120.

[0131] Each fixation arm 120a, 120b, 120c can be positioned one at a time during the procedure. As described elsewhere in this document, the leading fixation arm 120c can be in a straight configuration, while the trailing fixation arms 120a, 120b can be flexed (see [link to documentation]). Figures 17A-17DThe weight of the device can cause the pre-implanted or post-implantation leader arm 120c to bend, causing the device 100 to tilt backward toward the retina. In this case, the surgeon can position the device further back. However, this increases the risk of intraoperative tissue damage due to manipulation of instruments near the retina. In some embodiments, the leader arm 120c can be mechanically and / or geometrically reinforced to reduce the likelihood of posterior drift. The leader arm 120c can be made of a material resistant to such deformation. This material can be any implantable plastic or metal that can suspend the device after post-implantation at the anchor 125 of the leader arm 120c. Suitable materials include, but are not limited to, PMMA, rigid silicone, nylon, hydrophilic and hydrophobic acrylic resins, PEEK, polyimide, stainless steel, titanium, nitinol, etc. More rigid materials can be used to form the entire leader arm 120c or only a part of the leader arm 120c. The leader arm 120c can be formed from a softer material embedded with a more rigid material. In one embodiment, the leading fixing arm 120c may include a mechanically reinforced region 1205 between its starting point 103 at the support structure 105 and its end point 102 where it is connected to the anchor 125 (see [link]). Figure 17A Region 1205 can be achieved by increasing the thickness of the fixing arm 120c or by embedding the rigid plastic section into a softer material. Figure 17A The increased thickness (arrow T) at the mechanically reinforced region 1205 is shown compared to the thickness of the arm near the starting point 103 of the support structure (arrow O). Region 1205 may be spaced at a distance from the support member 105, for example, close to or adjacent to the anchor 125. Region 1205 may have an increased thickness (see [link to documentation]). Figures 17A-17D The device 100 is designed to specifically reduce the likelihood of rearward drift without affecting the ability to expose the anchor 125 of the fixation arm 120. For example, the fixation arm 120 may have a tapered thickness designed to limit deflection in the rearward direction. The tapered geometry may be thinnest near the anchor 125 and thickens at the center. The rear surface of the fixation can be used to bias the device forward relative to the eye. The contact angle between the rear surface of the fixation arm 120 and the wound can bias the device 100 in a manner that reduces the actual risk of rearward deflection of the fixation arm 120. Additional volume can further limit the deflection of the device and its proximity to the retina.

[0132] The transscleral fixation arm 120 and / or anchor 125 may have photoreactive or water-reactive elements, which facilitate sizing or fixation of the fixation arm. The geometry of the fixation arm can be expanded or contracted by expanding or contracting a portion of it to adjust its length during or after surgery. Alternatively, by expanding the anchor after the fixation arm is exposed, the anchor will provide more effective and secure fixation and reduce the risk of slippage.

[0133] The cross-shaped anchor of the fixation arm is capable of sliding along the fixation arm 120 with a certain amount of resistance. By adjusting the fixation arm 120 intraoperatively, the surgeon can specifically adjust the size of the device 100 for a given patient. Customized adjustment reduces the risk of slippage and adjustment of the effective lens position. Once the fixation arm 120 is set to the appropriate tension, excess material can be removed, for example, by trimming.

[0134] Device 100 may be made of materials or contain a geometry that can be used as a drug delivery device (including a refillable drug delivery device). A robustly fixed device accessible in the subconjunctival space will provide opportunities to deliver drugs to both the posterior and anterior segments. Examples of treatment may include one or more drugs for lowering intraocular pressure (glaucoma drugs), steroids, biological agents such as anti-vascular endothelial growth factor (anti-VEGF), gene therapy, antibacterial, antiviral, chemotherapy, nonsteroidal anti-inflammatory drugs, and other drugs for treating ocular or systemic diseases.

[0135] Device 100 may include a structure in which an IOL haptic element 114 can be fixed. In some cases, the IOL haptic element 114 may be fixed in a groove. However, it may be advantageous to provide a location for haptic fixation within the device itself. The structure of device 100 may be one or more recesses on the inner wall 109 of the lens support structure 105, the size and shape of which are designed to receive the IOL haptic element 114. Alternatively, the front or rear surface of device 100 may include slots or loops that can receive and fix the IOL haptic element 114 in place. The lens support structure 105 may have one or more apertures through which the IOL haptic element 114 can pass. Alternatively, the haptic geometry may be designed such that the IOL haptic element 114 can be wrapped around one or more fixation arms 120. The fixation arms 120 may also have apertures through which the IOL haptic element 114 can pass.

[0136] Device 100 can be designed to accommodate any form of intraocular lens 110 with any tactile design and any optical design. Device 100 can be designed to fit a specific IOL design with a geometry specifically designed to mate with lens support structure 105. This design can be particularly suitable for allowing lens replacement. Lens support structure 105 can be manufactured together with integrated lens 110 providing refractive correction. Correction can include, but is not limited to, monofocal, extended depth of focus, adaptive, light-tunable, multi-piece / replaceable, or multifocal IOL optics.

[0137] The device described herein can be used with IOLs having any of a variety of conventional designs, including multi-piece and one-piece designs. IOL 110 may include a central optics 112 and two tactile elements 114 (see, for example...) Figure 19B-19C 20B-20C, 24B, 24C, 24F, 25B, 25C, 26B, 26C, and 26E). The tactile element 114 can be a conventional open-loop tactile element, such as a C-ring, J-ring, modified J-ring, or other tactile element. The IOL 110 can be positioned above (or below) the central opening 115 of the device, such that the central axis CA extending through the central opening 115 extends through the optics 112 of the IOL 110. As described elsewhere herein, the tactile element 114 of the IOL 110 can project upward or forward away from (or towards if positioned below) the lens support structure 105. A one-piece IOL can have an open-loop tactile element similar to that of a conventional three-piece IOL. A one-piece IOL can also incorporate a single-piece plate tactile element. In devices shown as having one type of IOL (e.g., as... Figure 19B-19C And the multi-piece IOL shown in 20B-20C Figure 24B , 24C In the case of the one-piece IOL shown in 24F, 25B, 25C, 26B, 26C, and 26E, it should be understood that another type of IOL can be used with this device. The device described herein can be used with any type of IOL described elsewhere herein, including multi-piece and one-piece designs. Similarly, the tactile feedback of the IOL can be any of a variety of configurations.

[0138] The lens support structure 105 may have a geometry adapted to match the periphery of the IOL or one or more tactile elements of the IOL. The geometry may include a concavity, recess, channel, or groove forming at least a portion of the inner periphery of the lens support structure.

[0139] Figures 24A-24F Figures 25A-25C and 26A-26E illustrate various embodiments of a device configured to cooperate with an IOL such that at least a portion of the IOL is covered by at least a portion of the inner surface of the device.

[0140] Figures 24A-24F An embodiment of a device 2100 having a lens support structure 2105, a central aperture 2115, and a plurality of fixation arms 2120 is shown. The central aperture 2115 may be defined by the inner periphery or inner wall 2109 of the lens support structure 2105. The central aperture 2115 may be circular, but the outer periphery or outer wall 2111 of the lens support structure 2105 may be non-circular. As described elsewhere herein, the outer periphery of the lens support structure 2105 may have any of a variety of shapes, including circular, non-circular, oval, elliptical, and rounded rectangular. Figures 25A-25C ), inverted triangle ( Figures 26A-26EThe lens support structure 2105 can support the IOL 110, for example, in place of the native lens capsule. The device 2100 may include one or more leaflets or canopies 2126 positioned above the anterior surface of the lens support structure 2105 to form one or more recesses 2104 within which at least a portion of the IOL 110 can be positioned. The recesses 2104 may at least partially surround the central aperture 2115 and are sized to accommodate at least a portion of the IOL, such as the haptic element 114. Figure 24B , 24C Figure 24F shows an IOL 110 engaged with device 2100. Optics 112 of IOL 110 are positioned above central opening 2115, and a peripheral region of the posterior surface of optics 112 is positioned against the anterior surface of lens support structure 2105. Each tactile element 114 of IOL 110 can be substantially positioned within a corresponding recess 2104, and a large portion of the optics 112 of IOL 110 remains outside the recess 2104. The recess 2104 can be defined by the anterior surface of lens support structure 2105 and a canopy or awning 2126. The volume of the recess 2104, formed by the space between the anterior surface of lens support structure 2105 and the posterior surface of awning 2126, is sufficient to receive a corresponding one of the tactile elements 114 in terms of its front-to-back depth and distance from the central axis CA of opening 2115. The canopy 2126 may have a smooth geometry and can be used to protect the iris from any sharp edges of the IOL once it is positioned on the device 2100. Additionally, the center-facing surface of the canopy 2126 (facing the central axis CA of the device 2100) can additionally provide a surface that the tactile element 114 can abut against. These surfaces can provide counter-pressure to the tactile element and thus help center the IOL 110 on the device 2100. The canopy 2126 can also limit the Z-axis movement of the tactile element 114 and help secure the IOL 110 to the device 2100. Reliable fixation of the IOL (including one-piece IOLs) allows the use of IOLs requiring tight centering tolerances (e.g., toric, multifocal, extended depth-of-focus (EDOF) IOLs, and accommodative IOLs).

[0141] The IOL 110 can be positioned within the device 2100 before or after implantation into the eye. Similarly, the IOL 110 can be removed from the device 2100 and replaced post-operatively.

[0142] Figures 24A-24FAn embodiment of the device 2100 with an outer periphery 2111 is shown. The outer periphery 2111 is substantially elliptical in shape, having a major axis and a minor axis. Therefore, the inner periphery 2109 can define a circular central hole 2115, and the outer periphery 2111 can define a non-circular shape. The recesses 2104 formed by the canopy 2126 are positioned relative to each other with respect to the major axis, such that the span of the tactile element 114 of the IOL 110 can be accommodated within the recesses 2104.

[0143] Figures 25A-25C Another embodiment of the device 2100 with a circular central hole 2115 and a non-circular outer periphery 2111 is shown. Figures 25A-25C The non-circular outer periphery 2111 of the lens is a rounded rectangle with two generally flat, elongated sides 2108 and two generally rounded short sides or convex corners 2107. Recesses 2104 formed by the canopy 2126 can protrude above the anterior surface of the lens support structure 2105, such that they are positioned generally opposite each other and spaced apart along the long axis of the rectangle to accommodate the span (or width) of the tactile 114 of the IOL 110. For example, the canopy 2126 can protrude above the anterior surface of the lens support structure 2105 on the short side of the rounded rectangle (i.e., at the location of the convex corners 2107) to accommodate the span of the IOL within the recess 2104 along the long side 2108.

[0144] Three fixation arms 2120 can be coupled to the lens support structure 2105. As described elsewhere herein, at least one of the fixation arms 2120a, 2120b can be biased into a folded configuration. One fixation arm 2120c can be a leading fixation arm extending perpendicularly to the lens support structure 2105 along a single axis, such that its end 2102, which is coupled to the anchor 2125, projects outwardly away from the central axis CA of the hole 2115. The leading fixation arm 2120c can be coupled to the lens support structure 2105 at a convex angle 2107, and the other fixation arms 2120a, 2120b can be coupled away from the convex angle 2107 of the leading fixation arm, for example, on opposite sides 2108, such that opposite convex angles 2107 project outwardly between arms 2120a, 2120b (see [link to documentation]). Figures 25A-25B ).

[0145] Figures 26A-26EAnother embodiment of the device 2100 with a circular central aperture 2115 and a non-circular outer periphery 2111 is shown. As described elsewhere herein, the non-circular shape of the outer periphery 2111 can be a rounded triangular shape with a plurality of convex angles 2107 projecting outward from a plurality of side faces 2108. Each of the three fixation arms 2120 can extend outward from a corresponding side of the plurality of side faces 2108. Canopies 2126 can project above the anterior surface of the lens support structure 2105 such that they are positioned generally relative to each other. A first canopy 2126 can be positioned on a side face 2108 near, for example, the origin 2103 of the leading fixation arm 2120c, and a second canopy 2126 can be positioned on the convex angle 2107 between the other two fixation arms 2120a, 2120b (see [link to documentation]). Figures 26A-26B The arrangement of the canopies 2126 relative to each other is rotatable, such that the first canopy 2126 can be positioned on the convex angle 2107 adjacent to the starting point 2103 of the leading fixation arm 2120c, and the second canopy 2126 can be positioned on the side of the starting point 2103 of one of the flexion fixation arms 2120a, 2102b. Regardless of orientation, the span of the recess 2104 defined by the canopies 2126 and the lens support structure 2105 is sufficient to accommodate the span of the IOL haptic element 114 therebetween (see...). Figure 26C ).

[0146] The central opening 2115 may have a diameter as described elsewhere herein, such that the optics 112 of the IOL can be supported on the forward surface of the lens support structure 2105 without slipping through its diameter (e.g., between about 4 mm and about 6 mm). The IOL can be inserted into a recess 2104 beneath the canopy 2126. Therefore, the diameter between the first and second opposing canopies 2126 is sufficient for IOL insertion. The IOL is typically foldable, and thus the diameter between the first and second canopies 2126 can vary widely. In some embodiments, the opposing canopies 2126 are fully connected to each other along the side 2108 (see [link to documentation]). Figure 24C The opposing canopy 2126 may include extensions along each side 2108, thereby forming a complete overhanging surface over the lens support structure 2105 defining the upper aperture 2127. The upper aperture 2127 may have a diameter larger than the diameter of the central aperture 2115 of the lens support structure 2105. For example, the upper aperture 2127 may be larger than about 6 mm so that the IOL can be manipulated into place and fully extended to the position with the recess 2104. The diameter of the upper aperture 2127 may be larger than 6 mm up to about 8 mm.

[0147] Figure 27A related embodiment of the device 2100 with a canopy 2126 is shown, which additionally incorporates a plurality of buffers 2119 to help center the device 2100 within the eye. The device 2100 may include four buffers 2119 projecting outward from each corner of a lens support structure 2105. The buffers 2119 may be substantially annular or incompletely annular with a C-shape. An annular buffer 2119 may include a first end and a second end, both connected to the lens support structure 2105. A C-shaped buffer 2119 may have one end connected to the lens support structure 2105 and a second end remaining separate from the lens support structure 2105. Regardless of shape or configuration, the buffers 2119 can urge the device 2100 away from adjacent eye tissue. In some embodiments, the buffers 2119 may slightly deform upon contact with the ciliary structures. The deformation may be temporary, allowing the buffer to return to its original shape, thereby urging the device 2100 back to a centered position within the eye. As with other embodiments described herein, device 2100 may include a plurality of fixation arms 2120, including at least one fixation arm biased into a folded configuration. Preferably, once device 2100 is implanted, buffer 2119 avoids maintaining contact with the ciliary structure. Buffer 2119 may act as a guide during the display of fixation arms 2120. Buffer 2119 may project sufficiently away from the outer periphery 2111 of lens support structure 2105 such that they abut against ciliary body 15 and / or within ciliary sulcus 25 to prevent displacement in the Z-plane, thereby maintaining proper alignment between central aperture 2115 and the visual axis of the eye during fixation.

[0148] A needle or guidewire (with or without sutures) can be molded to the end plate or anchor 125, making the fixation arms 120 visible from both inside and outside the eye. The needle or guidewire (as appropriate) can be visible in a precise location before the body of the device 100 is inserted into the eye. Once the surgeon is satisfied with the placement of the needle or guidewire, the device 100 can be inserted into the eye, and each fixation arm 120 can be secured in place through appropriate procedures to ensure centered and z-axis positioning. Once the device 100 is properly secured, the surgeon can trim the sutures and / or needles from the device 100, leaving the anchor 125 in place. Alternatively, a modified pointed forceps / grasper (for inserting the lens fixation device) can be inserted through the main membrane wound, and then the fixation arm 120 can be engaged and visible using the pointed forceps / grasper. This allows for a single pass to create a sclerotomy and make the fixation arm anchor 125 visible.

[0149] The device 100 can be inserted through a corneal or scleral incision using forceps or other common ophthalmic instruments. Alternatively, a syringe system similar to an intraocular lens injector can be used to insert the device 100. The syringe allows the device 100 to be extended in a manner that presents the fixation arms 120 sequentially to the surgeon. Alternatively, the syringe can deliver the complete device 100 into the anterior or posterior chamber in a configuration that limits the risk of surgical error. For example, the syringe can ensure that the device 100 is inserted "face up". Furthermore, the syringe can limit the risk of damage to the iris 10, endothelium, capsular bag, or fasciculus during implantation.

[0150] The device 100 described herein provides a stable platform and acts as an artificial anterior side for placing the capsular bag of the IOL 110. Reliable centering and axial positioning of the lens support structure 105 are important for optimal functioning of the device 100. In some embodiments, a guiding system can be used to align the scleral incision site. The guiding system may employ features similar to intraoperative toric surface marking and preoperative toric surface bubble marking. In addition to marking the correct meridian position, the markings can also help align the incision relative to the limbus. Acceptable locations for the scleral incision may include posterior to the limbus and anterior to the ora serrata. In the human eye, the scleral incision can be placed approximately 0.1 mm to approximately 4 mm posterior to the limbus. By varying the anterior / posterior scleral incision site relative to the limbus between approximately 0.1 mm and approximately 4 mm (z-axis) or between approximately 1.5 mm and approximately 4 mm, the fixation arm tension can be controlled within acceptable limits. The optimal size and position of the device 100 can be determined using a guiding / marking system with marker / device pairs of different diameters. Figures 14A-14B and Figure 15A-15I An example sclerotomy guide tool 1000 is shown, which incorporates multiple marking features 1005 that aid in identifying and marking the sclerotomy site for insertion into the fixation arm 120 of the device 100. The tool 1000 may incorporate three marking features 1005 protruding from a distal region 1015 of a handle 1010. The handle 1010 may extend along a first axis A, and the distal region 1015 may be angled away from the first axis A. The marking features 1005 may protrude distally to the angled distal region 1015, such that the features 1005 are offset from the first axis A. The distal region 1015 of the tool 1000 may form a tripod 1020, wherein the features 1005 protrude from each tip 1025 of the tripod 1020 (see [link to documentation]). Figure 14A The distal region 1015 of tool 1000 may include a ring 1030 and a marking feature 1005 protruding from the distally facing surface of the ring 1030 (see...). Figure 14BThe ring 1030 can provide centering functionality. The surgeon can use the limbus, pupil, or white-to-white as a reference. The marking feature 1005 can generate 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 required by the fixation device 100.

[0151] Each marker feature 10005 can protrude outwards and to the far side a certain distance from the ring 1030 (or tripod 1020). Figures 15A-15D The embodiment of tool 1000 is shown, and... Figures 14A-14B Compared to the illustrated embodiment, it incorporates a larger spacing relative to the ring 1030 at the marker feature 1005. The marker feature 1005 may have a length between its starting point and its distal tip 1035 at the ring 1030, providing a spacing between approximately 1 mm and approximately 10 mm, or approximately 3 mm and approximately 6 mm. The tool 1000 avoids interaction with ophthalmic instruments such as speculum, cannulas, or other instruments that may be located on the surface of the eye during surgery. In some embodiments, the ring 1030 may additionally incorporate a crosshair 1040 for centering (see...). Figure 15H-15I The distance between the farthest tip 1035 of each marking feature 1005 and the ring 1030 provides a sufficiently high spacing to prevent the ring 1030 (or the crosshair 1040, if present) from contacting the cornea during use (see [link]). Figure 15E-15G ).

[0152] The inner diameter of ring 1030 can be between approximately 5 mm and approximately 15 mm (see...). Figure 16A The total diameter defined by the distal tip 1035 of tool 1000 can be between about 11 mm and about 18 mm, or between about 13 mm and about 17 mm (see...). Figure 16B The marking features 1005 can be symmetrically distributed around the circumference of the ring 1030. For example, if there are three marking features 1005, each marking feature can be positioned approximately 120 degrees apart from each other around the circumference. Each marking feature 1005 can be combined with a bevel or double bevel leading to the distal tip 1035, such that the distal tip 1035 forms a generally sharp point suitable for marking the sclera, for example by creating a notch (see...). Figures 16A-16D The bevel at the point where the distal tip 1035 is generated can extend from about 0.15 mm to about 1.5 mm in length. The distal tip 1035 can be angled inward toward the center of the ring 1030, such that the distal tip 1035 is offset from the outermost extension of the marking feature 1005 (see...). Figure 16DThe offset of the tip 1035 relative to the outermost extension of the marking feature 1005 can be a distance between about 0.15 mm and about 1.5 mm from the outermost extension. Each marking feature 1005 can have a length between about 3 mm and about 10 mm, and the beveled portion leading to the distal end 1035 can be between 0.15 mm and about 1.5 mm of that length. The tip 1035 does not need to be sharpened to provide marking functionality for the sclera. Figures 14A-14B As shown, the tip 1035 can be blunt and can still be used to mark the sclera. The tip 1035, whether blunt or sharp, can be used to mechanically mark the sclera by creating multiple notches or by applying individual visual marks to the sclera. For example, the lower end of each tip 1035 can be used to transfer a certain amount of ink or other visually suitable transferable material to the sclera from the tip 1035.

[0153] Anchor 125 can be displayed using standard tools used in ophthalmology. Figure 17C-17DA snare device 200 for exposing anchor 125 is shown. As discussed elsewhere herein, the pad or anchor 125 is designed for exposing via sclerotomy (e.g., 23, 25, or 27 sclerotomy). The snare device 200 may be designed to grip and release the anchor 125 and / or fixation arm 120 for transscleral fixation. The snare device 200 may include an adjustable ring 205 configured to expand and collapse in size. The ring 205 may pass through a portion or the entire anchor 125. The ring 205 may be tightened such that the opening area of ​​the ring 205 is reduced for secure engagement with the anchor and / or fixation arm. Surgeons can use the device 200 with a minimized ring 205 surrounding the fixation arm / anchor to expose the anchor 125 with minimal risk of losing grip on the anchor 125. When the anchor 125 is exposed, the ring 205 can at least partially reopen to increase the opening area of ​​the ring 205 to release the anchor 125. In a fully or partially open configuration, the ring 205 may have an inner circumference of about 1.5 mm to about 10.0 mm. In a closed capture configuration, the inner circumference of the ring 205 may be about 0.25 mm to about 2.5 mm. The snare device 200 may be designed such that the ring can non-invasively grasp the anchor 125 and / or the retaining arm 120 without damaging the device 100. For example, the snare device 200 may be without sharp corners. The material of the ring 205 provides mechanical properties that allow the ring 205 to non-invasively capture the arm 120 and repeatedly transition between a large circumferential configuration to a small circumferential configuration and back to a large circumferential configuration. The material of the ring 205 may provide a tight grip by means of non-invasive interaction with the retaining arm 120 or the anchor 125. The ring 205 can deform significantly during exposure when gripping the fixed arm 120 or the anchor 125. At least a portion of the snare device 200 can be bent. For example, the snare device 200 can be manufactured to have a bend near the distal region or be manually bent by the user during use to meet ergonomic needs.

[0154] Ring 205 can be a linear structure with a full radius of curvature. The linear structure can be a rigid material, such as stainless steel, titanium, nitinol, or other metals. Alternatively, the linear structure can be made of plastics, such as polypropylene, polyethylene, nylon, Gortex, polyimide, PMMA, or other plastics. Alternatively, the filamentary structure of ring 205 can be made of an elastomer material, such as flexible acrylic resin, polyurethane, silicone resin, SIBS, or other elastomer polymers with similar mechanical properties.

[0155] The snare device 200 can also be configured to perform sclerotomy and / or be used as an IOL gripper. Figures 18A-18D An embodiment of the snare device 200 is shown. A ring 205 or other snare features may extend from the internal lumen of the device. Figure 17C-17DAs shown, the opening from the internal lumen can be located distally. (As...) Figures 18A-18B As shown, the opening from the internal lumen can also be located proximal to the distal end via the sidewall of the device, or as... Figure 18C-18D As shown, the device is forged such that the sharp tip extends distally to the orifice through which the ring 205 exits the lumen. The device may have additional features to protect the sheath material and the device from damage by the sharp edge of the distal tip 210. For example, the sharp distal tip 210 of the needle may be covered by a sheath or other element having a lumen and configured to extend beyond the distal tip 210. This outer sheath provides a non-invasive surface through which the ring 205 can be secured. Alternatively, the puncture tip 210 may be located at a distance from the opening 215 through which the ring 205 is operated, for example, approximately 0.2 mm to 10 mm away from the opening 215. The device 200 may incorporate a distal tip 210 suitable for performing sclerotomy. The distal tip 210 may have various geometries, such as... Figures 18A-18B The non-core cannula tip shown or as Figure 18C-18D The rear beveled needle tip is shown. The geometry of the distal tip 210 may include, but is not limited to, beveled, three-sided needle, conical, rhomboid, pencil tip, forged, machined, or other pointed geometries.

[0156] In another embodiment, a forceps-type device can be used to expose the anchor 125. The forceps can be straight or angled. The forceps device can enhance the surgeon's grasp by incorporating a locking function. The forceps device for exposure can transition from a locked to an unlocked state and vice versa via any of a variety of mechanical movements, including twisting, squeezing, sliding, and mechanisms that reduce the range of forceps movement once engaged. In some embodiments, locking forceps have two gripping surfaces locked in a restricted configuration. In other embodiments, the forceps have three or four gripping surfaces that can lock into a restricted configuration. The locking or restricted configuration can also enclose the anchor 125 within a sheath that facilitates the exposure process. Fully enclosing the anchor 125 can limit interference between the anchor and the sclera when the anchor is inserted into the wound. The sheath can define an outermost surface during exposure, which can be designed to interact optimally with 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 exposure. The sheath can be rigid enough to maintain its shape substantially during exposure.

[0157] The device described herein can be implanted into the posterior chamber of an eye without an intact capsular bag. As described elsewhere herein, prior to insertion into the posterior chamber, at least one of the at least three fixation arms can be biased toward a linear configuration and at least a second of the at least three fixation arms can be biased toward a folded configuration. The folded configuration includes an initial portion of the fixation arm extending away from the lens support structure, and a central portion of the fixation arm having a bend, fold, or flexion, such that the anchor of the distal portion can then be positioned above or below at least one of a portion of the lens support structure and a portion of the central opening. Once the device is inserted into the posterior chamber, at least a portion of the fixation arm in the folded configuration becomes visible through the pupil. The anchor of the straight fixation arm can be grasped and exposed through and above a first portion of the sclera. The anchor of the flexed fixation arm can be grasped, unfolded, and exposed through and above a second portion of the sclera. The third of the fixation arms can then be grasped, tensioned, and exposed through and above a third portion of the sclera to position and stabilize the device within the posterior chamber of the eye.

[0158] Suitable materials or combinations of materials for the various components of the device disclosed herein are provided throughout the text. It should be understood that other suitable materials may be considered. Device 100 may be constructed from any implantable material that provides the required functionality of the lens support structure 105, fixation arm 120, and anchor 125. Materials that can be used in this device may be, but are not limited to, silicone elastomers, fluorosilicone elastomers, polyurethanes, hydrophilic or hydrophobic acrylic resins, polyolefins, nylon, PVDF, PMMA, polyimide, nitinol, titanium, stainless steel, or other implantable materials. The device may be made from a combination of materials whose geometries are fitted together, chemically bonded or welded together, overmolded, encapsulated, or otherwise combined. Given device elements may be made from a variety of materials. Fixation arm 120 may be constructed from inelastic or semi-rigid materials commonly used in ophthalmic applications, such as polypropylene, nylon, PVDF, polyimide, PMMA, polyurethane, hydrophilic or hydrophobic acrylic resins, or high-hardness silicone resins. The fixation arm 120 may be incorporated with or formed of an elastic material, such as an acrylic resin, polyurethane, silicone elastomer, or copolymer thereof that facilitates manipulation of the fixation arm 120 during implantation. In a further embodiment, the fixation arm 120 may be formed of a semi-rigid or rigid plastic material, such as polypropylene, nylon, PVDF, polyimide, PMMA, polyurethane, hydrophilic or hydrophobic acrylic resins, or high-hardness silicone resins (e.g., acrylic resins, polyurethane, silicone elastomers, or copolymers thereof) embedded or coated with a soft elastomer material.

[0159] In various embodiments, reference is made to the accompanying drawings. However, certain embodiments may be practiced without one or more of these specific details or in combination with other known methods and configurations. Numerous specific details, such as specific configurations, dimensions, and processes, are set forth in the description to provide a thorough understanding of the embodiments. In other instances, well-known processes and manufacturing techniques are not described in particular detail to avoid unnecessarily obscuring the description. Throughout this specification, references to “an embodiment,” “an example,” “a implementation,” “implementation,” etc., mean that a particular feature, structure, configuration, or characteristic described is included in at least one embodiment or implementation. Therefore, phrases such as “an embodiment,” “an example,” “a implementation,” “implementation,” etc., appearing in different places throughout this specification do not necessarily refer to the same embodiment or implementation. Furthermore, particular features, structures, configurations, or characteristics may be combined in any suitable manner in one or more embodiments.

[0160] The devices and systems described herein can combine any of a variety of features. Elements or features of one embodiment of the devices and systems described herein can be combined alternatively or in combination with elements or features of another embodiment of the devices and systems described herein. For the sake of brevity, a detailed description of each of those combinations may be omitted, although various combinations will be considered herein. Furthermore, the devices and systems described herein can be positioned in the eye and do not require specific implantation as shown in the figures or as described herein. Various devices, etc., can be implanted, positioned, and adjusted according to various different methods and using various different devices and systems. Various devices can be adjusted before, during, and at any time after implantation. Some illustrative descriptions of how to implant and position various devices are provided; however, for the sake of brevity, a detailed description of each method for each implant or system may be omitted.

[0161] The use of relative terms throughout the description may indicate relative position, direction, or orientation and is not intended to be limiting. For example, "far side" may indicate a first direction away from a reference point. Similarly, "proximal side" may indicate a position in a second direction opposite to the first direction. The terms "upper," "lower," "top," "bottom," "front," "side," and "rear," as well as "forehead," "rear," "tail," "head," etc., are used to establish a relative frame of reference and are not intended to limit the use or orientation of any device described herein in various embodiments.

[0162] While this specification contains numerous details, these should not be construed as limiting the scope of the claims or potentially claimed protections, but rather as descriptions of specific features of particular embodiments. Certain features described in the context of individual embodiments may also be implemented in combination in a single embodiment. Conversely, various features described in the context of a single embodiment may also be implemented individually or in any suitable sub-combination in multiple embodiments. Furthermore, although features may be described above as functioning in certain combinations and even initially required in this way, in some cases one or more features of the claimed combination may be removed from the combination, and the claimed combination may be for sub-combinations or variations thereof. Similarly, although operations are depicted in a specific order in the drawings, this should not be construed as requiring such operations to be performed in the specific order or sequential order shown, or to perform all the operations shown to obtain the desired result. Only a few examples and implementations are disclosed. Variations, modifications, and enhancements may be made to the described examples and implementations, as well as other implementations, based on the disclosure.

[0163] In the foregoing description and claims, phrases such as “at least one of…” or “one or more of…” may appear after a linked list of elements or features. The term “and / or” may also appear 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 element or feature listed alone or in combination with any other recited element or feature. For example, the phrases “at least one of A and B”; “one or more of A and B”; and “A and / or B” all mean “A alone, B alone, or A and B together”. A similar interpretation applies to lists comprising three or more items. For example, the phrases “at least one of A, B, and C”; “one or more of A, B, and C”; and “A, B, and / or C” all mean “A alone, B alone, C alone, A and B together, A and C together, B and C together, or A and B and C together”.

[0164] The use of the term "based on" in the above and claims is intended to mean "at least partially based on," so that undescribed features or elements are also permitted.

Claims

1. An implantable device for supporting an artificial lens in the eye, the device comprising: The support structure includes: Central axis; The outer peripheral wall, including non-circular shapes; The front wall extends inward from the front portion of the outer peripheral wall toward the central axis, and the inner periphery of the front wall includes a non-circular shape having a first area; The rear wall extends inward from the rear portion of the outer peripheral wall toward the central axis, and the inner periphery of the rear wall includes a circle centered on the central axis and has a second area smaller than the first area; A single central hole extends through the full thickness of the support structure between the forward surface of the front wall and the rearward surface of the rear wall; and A recess for receiving at least a portion of the tactile element of the intraocular lens when the device is implanted, wherein the recess is defined by a portion of the outer peripheral wall, a portion of the anterior wall, and a portion of the posterior wall; and Multiple fixation arms are attached to the support structure and configured to be placed under tension and to position and stabilize the device within the eye. Each of the multiple fixation arms has an end attached to a transscleral anchor for seamless scleral fixation.

2. The apparatus according to claim 1, wherein, The transscleral anchor is configured to be non-invasively exposed.

3. The apparatus according to claim 2, wherein, The transscleral anchor can be positioned outside the sclera and inside the conjunctiva.

4. The apparatus according to claim 1, wherein, At least one of the plurality of fixed arms is non-planar.

5. The apparatus according to claim 1, wherein, The plurality of fixed arms includes three fixed arms extending outward from the outer peripheral wall of the support structure.

6. The apparatus according to claim 5, wherein, At least the first of the three fixed arms is offset toward the central axis of the support structure of the device.

7. The apparatus according to claim 6, wherein, At least the first and second fixed arms of the three fixed arms are each offset toward the central axis of the support structure of the device.

8. The apparatus according to claim 7, wherein, Compared to the cross-sectional area of ​​the first and second fixed arms, the third fixed arm of the three fixed arms has an increased cross-sectional area.

9. The apparatus according to claim 8, wherein, Compared to the stiffness of the first or second fixed arm, the increased cross-sectional area of ​​the third fixed arm increases its stiffness.

10. The apparatus according to claim 5, wherein, The three fixed arms are evenly distributed around the outer peripheral wall of the support structure.

11. The apparatus according to claim 1, wherein, In use, the support structure provides the device with centering without making 360-degree contact with the ciliary body along the outer peripheral wall of the non-circular shape.

12. The apparatus according to claim 1, wherein, In use, the non-circular outer peripheral wall of the support structure should avoid contact with the ciliary body or with the ciliary body at an angle of less than 120 degrees.

13. The apparatus according to claim 1, wherein, In use, the non-circular outer peripheral wall of the support structure contacts the ciliary process at three different points.

14. The apparatus according to claim 1, wherein, The outer peripheral wall of the support structure includes multiple convex angles that project outward from multiple flat or concave sides.

15. The apparatus according to claim 14, wherein, The plurality of convex angles includes three convex angles, thereby providing the support structure with a circular triangular shape.

16. The apparatus according to claim 15, wherein, The three convex corners provide anti-rotation functionality in the Z-plane.

17. The apparatus according to claim 15, wherein, In use, the three convex corners provide non-penetrating contact with the ciliary body.

18. The apparatus according to claim 1, wherein, The support structure includes one or more slits formed in the inner periphery of the rear wall defining the circular shape.

19. The apparatus according to claim 1, wherein, At least one of the plurality of fixed arms includes a plurality of anchors along its length, the plurality of anchors including a transscleral anchor at the end.

20. The apparatus according to claim 1, wherein, In use, the transscleral anchor is configured to be positioned outside the sclera.

21. The apparatus according to claim 20, wherein, The transscleral anchor includes a geometry configured to pass through the sclera in a first direction during insertion and to resist pull through the sclera in a second opposite direction.

22. The apparatus according to claim 20, wherein, When in a resting state, at least one of the plurality of fixed arms incorporates a bend between its starting point with the support structure and its end connected to the transscleral anchor, thereby forming a bent fixed arm.

23. The apparatus according to claim 22, wherein, The curved portion is between 90 degrees and 270 degrees from the starting point in both the radial and centripetal directions.

24. The apparatus according to claim 22, wherein, The curved portion is at a 180-degree angle to the starting point of the supporting structure.

25. The apparatus according to claim 22, wherein, When in a resting state, the end of the bent fixed arm is located in a plane different from the plane of the support structure, and the transscleral anchor is positioned above at least a portion of the support structure.

26. The apparatus according to claim 25, wherein, The curved fixed arm incorporates an elastic material or a deformable hinge to facilitate the straightening of the curved fixed arm, bringing the end close to the plane of the support structure.

27. The apparatus according to claim 22, wherein, The two fixed arms are flexible and have an inward bias, and the third fixed arm is less flexible than the two fixed arms.

28. The apparatus according to claim 1, wherein, The transscleral anchor of each of the plurality of fixed arms is configured to be positioned outside the sclera.

29. The apparatus according to claim 28, wherein, The transscleral anchor includes a central portion and one or more peripheral grippable portions, wherein the central portion is arranged above the wound, and the anchor is exposed through the wound during implantation.

30. The apparatus according to claim 29, wherein, Compared to the grippable portion, the central portion has increased thickness, height, and / or width.

31. The apparatus according to claim 1, wherein, One of the plurality of fixed arms is mechanically reinforced.

32. The apparatus according to claim 31, wherein, Mechanical reinforcement biases the device forward during implantation.

33. The apparatus according to claim 1, wherein, A portion of the anterior wall includes a first canopy extending above a recess, wherein at least a portion of the tactile element is located within the recess below the canopy when the support structure supports the intraocular lens, wherein a first portion of the inner periphery of the anterior wall includes the edge of the first canopy.

34. The apparatus according to claim 33, wherein, The anterior wall includes a second canopy extending above the second recess, wherein when the support structure supports the intraocular lens, a portion of the second tactile element of the intraocular lens is located within the second recess and below the second canopy.

35. The apparatus according to claim 34, wherein, A first portion of the inner periphery of the front wall includes the edge of the first canopy, and a second portion of the inner periphery of the front wall includes the edge of the second canopy.

36. The apparatus according to claim 5, wherein, At least one of the three fixation arms is biased to bend between the starting and ending portions of the fixation arm, such that at least a portion of one fixation arm is visible to the user through the pupil of the eye when the device is placed in the posterior chamber of the eye and before the transscleral fixation anchor.

37. The apparatus according to claim 1, wherein, The circular shape of the inner periphery of the posterior wall includes a dimension smaller than the diameter of the optical portion of the intraocular lens, and the non-circular shape of the inner periphery of the anterior wall includes a dimension larger than the diameter of the optical portion of the intraocular lens.

38. The apparatus according to claim 1, wherein, The non-circular shape of the outer peripheral wall of the support structure includes a pair of short sides and a pair of elongated sides, wherein the front wall includes a first canopy that extends above the recess at a first location near the pair of short sides, wherein the front wall includes a second canopy that extends above the second recess at a second location near the pair of short sides, wherein when the support structure supports the intraocular lens, a portion of the second tactile element of the intraocular lens is located within the second recess below the second canopy.

39. The apparatus according to claim 38, wherein, The first and second canopies are connected to each other along the pair of elongated sides, thereby defining the inner periphery of the front wall.

40. The apparatus according to claim 1, wherein, The non-circular shape of the outer peripheral wall includes a major axis, a minor axis, two elongated sides, and two short sides, wherein the two elongated sides extend along the major axis and the two short sides extend along the minor axis, wherein the front wall includes a pair of canopies extending toward the central axis and overhanging the rear wall, wherein each of the pair of canopies is adjacent to one of the two short sides, generally opposite to each other, and wherein one of the pair of canopies defines the recess.

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