Intraocular implant

Abstract

The present disclosure relates to an intraocular implant including at least a frame, a transcapsular spacer, and a fixing arm.

Description

INTRAOCULAR IMPLANTBACKGROUND

[0001] 1. Technical Field

[0002] The present disclosure describes an intraocular implant, and more particularly a transcapsular intraocular implant.

[0003] 2. Related Art

[0004] Intraocular lens dislocation, also known as ectopia lentis, occurs when an intraocular lens moves out of its normal position in the eye. Some symptoms of IOL dislocation include blurry vision, loss of vision, ocular pain, and headaches. IOL dislocation is typically related to a problem with: the integrity of a capsular bag; integrity of the zonules which supports the bag; and / or the collective ability of the bag and the zonules to support the lens. And there are many predisposing conditions that increase the risk of lens dislocation, capsular bag instability, and zonular weakness, including pseudoexfoliation syndrome, cataract surgery, prior vitreoretinal surgery, repeat ocular surgeries, aging, inflammation / uveitis, physical trauma, retinitis pigmentosa, diabetes, and / or connective tissue disorders e.g. Marfans.

[0005] It would be beneficial to provide an intraocular implant designed to prevent, repair, manage, and / or treat IOL dislocation, capsular instability, and / or zonule instability.SUMMARY

[0006] The present disclosure provides intraocular implants designed to prevent, treat, manage, and / or repair IOL dislocation, capsular instability, and / or zonule instability. The intraocular implants include at least a capsular frame, one or more transcapsular spacers, and one or more exterior haptics. The capsular frame may be generally planar extending along a firstplane and defining a frame opening therein. The capsular frame is configured to be positioned within a capsular bag of an eye. The capsular frame may be configured to be positioned completely within a capsular bag of an eye.

[0007] The one or more transcapsular spacers are positioned along the capsular frame and provide the implant with a height and / or depth. Each transcapsular frame extends between an endocapsular arm and an exocapsular arm. The endocapsular arm is fixed to the frame and extends inwardly from a first location of the frame towards a center of the frame opening. The exocapsular arm extends outwardly from the endocapsular arm. The endocapsular arm is configured to extend inwardly from the frame towards an opening in a capsular bag of an eye of a patient. The exocapsular arm is configured to extend outwardly away from the opening in the capsular bag of an eye of a patient and out of the capsular bag.

[0008] The one or more transcapsular spacers may include a plurality of transcapsular spacers. In some embodiments, the plurality of transcapsular spacers include two, three or four transcapsular spacers.

[0009] The one or more exterior haptics is fixed to and extend away from the exocapsular arm of the spacers. The exterior haptics extend between a fixed end part and free end part. The fixed end part is fixed to and extends from the exocapsular arm of the spacer. The free end part of the exterior haptics include a plurality of friction-enhancement members, such as ridges, protrusions, hooks, gripping members, barbs, etc. The one or more exterior haptics are configured to contact a tissue in the posterior chamber of the eye, such as the sulcus, to secure the implant in the eye and / or secure the capsular frame in the capsular bag of the eye.

[0010] The one or more exterior haptics may include a plurality of exterior haptics. In some embodiments, the plurality of exterior haptics include two, three or four exterior haptics.

[0011] In some embodiments, the plurality of exterior haptics extend around the frame in the same clockwise or counter-clockwise direction.

[0012] In some embodiments, the plurality of exterior haptics extend around the frame in a different clockwise or counter-clockwise directions.

[0013] In some embodiments, the plurality of exterior haptics define an open hour-glass configuration around the frame.

[0014] In some embodiments, the implants provided further include one or more interior haptics positioned on and exterior of the frame.

[0015] Methods of making and using the intraocular implants are also provided.BRIEF DESCRIPTION OF THE DRAWINGS

[0016] Embodiments of the presently disclosed implants are described herein with reference to the drawings, wherein:

[0017] Figs. 1 A is a perspective view of an intraocular implant as provided in one or more embodiments herein:

[0018] Figs. IB and 1C are schematic representations of an eye including the intraocular implant of Fig. 1 A therein as provided in one or more embodiments herein;

[0019] Fig. 2A is a perspective view of an intraocular implant as provided in one or more embodiments herein;

[0020] Fig. 2B is a top view of the intraocular implant of Fig. 2 A as provided in one or more embodiments herein;

[0021] Fig. 2C is a cross-sectional view of the intraocular implant of Fig. 2A as provided in one or more embodiments herein;

[0022] Fig. 2D is a side view of the intraocular implant of Fig. 2 A as provided in one or more embodiments herein;

[0023] Fig. 3 A is a perspective view of another intraocular implant as provided in one or more embodiments herein;

[0024] Fig. 3B is a top view of the intraocular implant of Fig. 3 A as provided in one or more embodiments herein;

[0025] Fig. 3C is a cross-sectional view of the intraocular implant of Fig. 3A as provided in one or more embodiments herein;

[0026] Fig. 3D is a side view of the intraocular implant of Fig. 3 A as provided in one or more embodiments herein;

[0027] Fig. 4A is a perspective view of yet another intraocular implant as provided in one or more embodiments herein;

[0028] Fig. 4B is a top view of the intraocular implant of Fig. 4 A as provided in one or more embodiments herein;

[0029] Fig. 4C is a front view of the intraocular implant of Fig. 4A as provided in one or more embodiments herein;

[0030] Fig. 4D is a side view of the intraocular implant of Fig. 4A as provided in one or more embodiments herein;

[0031] Fig. 4E is a cross-sectional view of the intraocular implant of Fig. 4A as provided in one or more embodiments herein;

[0032] Fig. 5 A is a perspective view of yet another intraocular implant as provided in one or more embodiments herein;

[0033] Fig. 5B is a top view of the intraocular implant of Fig. 5 A as provided in one or more embodiments herein;

[0034] Fig. 5C is a front view of the intraocular implant of Fig. 5A as provided in one or more embodiments herein;

[0035] Fig. 5D is a side view of the intraocular implant of Fig. 5 A as provided in one or more embodiments herein;

[0036] Fig. 6 is a top view of yet another intraocular implant as provided in one or more embodiments herein;

[0037] Fig. 7A is a perspective view of yet another intraocular implant as provided in one or more embodiments herein;

[0038] Fig. 7B is a top view of the intraocular implant of Fig. 7A as provided in one or more embodiments herein;

[0039] Fig. 7C is a front view of the intraocular implant of Fig. 7A as provided in one or more embodiments herein;

[0040] Fig. 7D is a side view of the intraocular implant of Fig. 7A as provided in one or more embodiments herein;

[0041] Fig. 8A is a perspective view of yet another intraocular implant as provided in one or more embodiments herein;

[0042] Fig. 8B is a top view of the intraocular implant of Fig. 8 A as provided in one or more embodiments herein;

[0043] Fig. 8C is a front view of the intraocular implant of Fig. 8 A as provided in one or more embodiments herein;

[0044] Fig. 8D is a side view of the intraocular implant of Fig. 8A as provided in one or more embodiments herein;

[0045] Fig. 9 A is a perspective view of yet another intraocular implant as provided in one or more embodiments herein;

[0046] Fig. 9B is a top view of the intraocular implant of Fig. 9 A as provided in one or more embodiments herein;

[0047] Fig. 9C is a cross-sectional view of the intraocular implant of Fig. 9A as provided in one or more embodiments herein;

[0048] Fig. 9D is a side view of the intraocular implant of Fig. 9A as provided in one or more embodiments herein;

[0049] Fig. 10A is a perspective view of yet another intraocular implant as provided in one or more embodiments herein;

[0050] Fig. 10B is a top view of the intraocular implant of Fig. 10A as provided in one or more embodiments herein;

[0051] Fig. 10C is a front view of the intraocular implant of Fig. 10A as provided in one or more embodiments herein;

[0052] Fig. 10D is a side view of the intraocular implant of Fig. 10A as provided in one or more embodiments herein;

[0053] Fig. 10E is a perspective bottom side view of the intraocular implant of Fig. 10A as provided in one or more embodiments herein;

[0054] Fig. 10F is a perspective top side view of the intraocular implant of Fig. 10A as provided in one or more embodiments herein;

[0055] Figs. 10G and 10H are each cross-sectional views of the intraocular implant of Fig. 10A as provided in one or more embodiments herein;

[0056] Fig. 11 A is a perspective view of yet another intraocular implant as provided in one or more embodiments herein;

[0057] Fig. 11B is a top view of the intraocular implant of Fig. HAas provided in one or more embodiments herein;

[0058] Fig. 11C is a cross-sectional view of the intraocular implant of Fig. 11 A as provided in one or more embodiments herein;

[0059] Fig. 11D is a side view of the intraocular implant of Fig. HAas provided in one or more embodiments herein;

[0060] Fig. 12A is a perspective view of yet another intraocular implant as provided in one or more embodiments herein;

[0061] Fig. 12B is a top view of the intraocular implant of Fig. 12A as provided in one or more embodiments herein;

[0062] Fig. 12C is a cross-sectional view of the intraocular implant of Fig. 12A as provided in one or more embodiments herein;

[0063] Fig. 12D is a side view of the intraocular implant of Fig. 12A as provided in one or more embodiments herein;

[0064] Figs. 13A-13L are each a top schematic representation of various suitable frame shapes as provided in one or more embodiments herein;

[0065] Fig. 14 is a perspective view of yet another intraocular implant as provided in one or more embodiments herein; and

[0066] Fig. 15 is a cross-section side view of yet another intraocular implant as provided in one or more embodiments herein.DETAILED DESCRIPTION

[0067] The present disclosure provides a three-dimensional intraocular implant. The implant is designed to stabilize at least a capsular bag of an eye, alone or with an intraocular lens positioned therein. The implant may also stabilize an intraocular lens positioned inside the capsular bag of the eye and / or stabilize the zonules which support both the bag and the lens.

[0068] Figs. 1 A-1C depict at least one embodiment of the ocular implants described herein. The implant 10 includes a generally planar capsular (i.e., endocapsular) frame 12, one or more transcapsular spacers 22, 24, and one or more exterior (i.e., exocapsular) haptics 32, 34.

[0069] Fig. IB depicts a schematic cross-sectional representation of an eye 2 including an intraocular implant 10 implanted in an eye 2. The eye 2 includes a cornea 3, an iris 4, a capsular bag 5 with opening 6, zonules 7, and a sulcus 8, as well as anterior and posterior chambers 9a, 9b. Fig. 1C depicts a schematic representation from a rear view of the eye 2 (and / or bag 5) and implant 10 of Fig. 1A.

[0070] As illustrated in Figs. IB and 1C, the capsular frame 12, when properly implanted, is retained solely within the capsular bag 5 (i.e., an endocapsular frame), the exterior haptics 32, 34 are retained outside the capsular bag 5 (i.e., exocapsular haptics) in a tissue of the posterior chamber 9b, such as the sulcus 8, to secure the implant 10 in the eye 2, and the spacers extend across the capsular bag 5 (i.e., transcapsular spacer) from the frame 12 inside the bag 5 to the exterior haptics 32, 34 located outside the bag 5. The exterior haptics 32, 24 are configured to contact a tissue of the posterior chamber 9b of the eye 2, such as the sulcus 8, to secure theimplant 10 in the eye 2, and more particularly secure the capsular frame 12 inside the capsular bag 5.

[0071] By using the exterior haptics 32, 34 outside the capsular bag 5 to secure the capsular frame 12 inside the capsular bag 5 (i.e., exocapsular securement), both the frame 12 and the bag 5 are stabilized and locked into place relative to each other in the eye 2. The improved stability minimizes and / or eliminates movement of the bag 5, the frame 12, and / or any intraocular lens positioned inside the bag 5. Thus, the transcapsular implants described herein may be used with any type of intraocular lens, and particularly more advanced lenses, such as bifocal and / or multifocal lenses. In addition, the stability of the implant improves the likelihood of accurately calculating the Effective Lens Position (ELP). The ELP represents the distance between the principal image plane of the cornea and the principal object plane of the intraocular lens (IOL) in the eye. An accurate ELP can be crucial for accurate IOL power calculation and / or for achieving the desired refractive outcome after cataract surgery. The exocapsular securement of the capsular frame 12 within the bag 5 also allows the implant 10 to be used in an eye 2, even if the zonules 7 of the eye 2 are not intact, missing, and / or damaged due to disease and / or repetitive surgeries, particularly when the frame 12 is secured in the sulcus 8.

[0072] The implants provided herein also provide sufficient stability following implantation which not only improves the likelihood of placing an intraocular lens at or near the Effective Lens Position (ELP), but further because

[0073] Turning now to Figs. 2A-2D, the intraocular implant 10 is shown in more detail (without the eye and / or capsular bag). In some embodiments, the intraocular implant 10 includes at least a capsular frame 12, one or more transcapsular spacers 22, 24, and one or more exterior haptics 32, 34. The capsular frame 12 is configured to be positioned and / or maintainedcompletely with the capsular bag of an eye to exert an outward force that redistributes tension evenly across the capsular bag to stabilize and / or flatten the capsular bag 5. The one or more transcapsular spacers 22, 24 connect the frame 12 to the one or more exterior haptics 32, 34 vertically spaced from the frame 12. The spacers 22, 24 are configured to extend from an interior of the capsular bag to an exterior of the capsular bag through the opening or capsulorhexis in the capsular bag. The one or more exterior haptics 32, 34 are configured to remain outside the capsular bag to contact tissue in the posterior chamber of the eye, and particularly the sulcus, to secure the implant 10 in the eye.

[0074] The capsular frame 12 extends generally along a first plane pi defining a frame opening 14 therewithin. The one or more haptics 32, 34 extend generally along a second axis p2 which is parallel to the first axis pi. The one or more spacers 22, 24 connect the frame 12 to the haptics 32, 34 and provide a verticality and / or height h to the implant 10. The one or more spacers 22, 24 may also shift the exterior haptics 32, 34 laterally around the frame 12 and away from where the spacer 22, 24 meets the frame 12.

[0075] The capsular frame 12 may be an open frame (see, e.g., Fig. 2A) or a closed frame (see, e.g., Fig. 11 A). The frame 12 may be made from any suitable biocompatible material. In some embodiments, the frame 12 is made, in whole or in part, from a suitable non-bioabsorbable or inert polymeric material. In some embodiments, the frame 12 is made, in whole or in part, from an acrylic or methacrylic material, poly(methyl methacrylate), silicone, or combinations thereof. In some embodiments, the frame 12 is made, in whole or in part, from a suitable bioabsorbable material.

[0076] The capsular frame 12 may display a thickness (i.e., diameter) ranging from 0.01 mm to 1 mm. In some embodiments, the thickness of the frame 12 ranges from 0.05 mm to 0.5mm. In some embodiments, the thickness of the frame 12 ranges from 0.1 mm to 0.4 mm. In some embodiments, the thickness of the frame 12 ranges from 0.15 mm to 0.35 mm. In some embodiments, the thickness of the frame 12 is about 0.16 mm. In some embodiments, the thickness of the frame 12 is about 0.35 mm.

[0077] In some embodiments, the capsular frame includes poly(methyl methacrylate) and the frame thickness ranges from 0.05 mm to 0.25 mm. In some embodiments, the capsular frame includes a silicone material and the frame thickness is about 0.16 mm.

[0078] In some embodiments, the capsular frame includes a silicone material and / or a foldable acrylic polymer. The frame thickness may range from 0.15 mm to 0.5 mm. In some embodiments, the capsular frame includes a silicone material and the frame thickness is about 0.35 mm.

[0079] In some embodiments, as shown in Figs. 2A-2D, the capsular frame 12 defines a circular shape or ring, and more particularly an open circular shape or ring 12 defining the opening 14. The open ring 12 extends between opposing ends 12a, 12b with a frame gap 13 therebetween. At least one, if not both, of the opposing ends 12a, 12b may be blunt, rounded, or curvilinear.

[0080] The diameter di (or width) of the opening 14 across the frame 12 may range between 5 and 15 mm. Although the frame 12 of Figs. 2A-2D is depicted as circular, use of the term diameter is not intended to be limited to only circular shaped frame but rather may encompass a maximum length between opposing sides of the frame which passes through a center of the frame for any shape. In some embodiments, the diameter di represents the outer diameter of the ring.

[0081] In some embodiments, the diameter di of the opening across the frame 12 ranges from 6 and 12 mm. In some embodiments, the diameter di of the opening across the frame 12 may range from 7 and 10 mm. In some embodiments, the diameter di of the opening across the frame is about 7 mm or about 10 mm.

[0082] In some embodiments, the thickness of the frame 12 ranges from 0.1 mm to 0.4 mm and the diameter of the frame opening 14 ranges from 7 mm to 10 mm. In some embodiments, the thickness of the frame 12 is about 0.16 mm and the diameter of the frame opening 14 ranges from 7 mm to 10 mm. In some embodiments, the thickness of the frame 12 is about 0.35 mm and the diameter of the frame opening 14 ranges from 7 mm to 10 mm.

[0083] As further depicted in Fig. 2B, the frame gap 13 defines a radial gap angle ai between the opposing ends 12a, 12b of the frame 12. The radial gap angle ai as shown in Fig. 2B is about 45 degrees, however the radial gap angle ai may range from about 1 degree to about 180 degrees.

[0084] In some embodiments, the radial gap angle ai ranges from 20 to 60 degrees. In some embodiments, the radial gap angle ai ranges from 40 to 140 degrees. In some embodiments, the radial gap angle ai ranges from 60 to 120 degrees. In some embodiments, the radial gap angle ai is a right angle. In some embodiments, the radial gap angle ai is an acute angle. In some embodiments, the radial gap angle ai is about 45 degrees.

[0085] In addition to the endocapsular frame 12, the implants 10 described herein also includes at least one transcapsular spacer 22, 24. As further shown in Figs. 2A-2D, in some embodiments, the implant 10 includes at least a first transcapsular spacer 22 and a second transcapsular spacer 24. Each spacer 22, 24 extends between an endocapsular (i.e., interior) arm22a, 24a and an exocapsular (i.e., exterior) arm 22b, 24b. The endocapsular arm 22a, 24a isconfigured to be positioned within the capsular bag and an exocapsular arm 22b, 24b is configured to be positioned outside the capsular bag.

[0086] As depicted, in some embodiments, the first endocapsular arm 22a of the first spacer 22 extends inwardly from a first location Ila of the capsular frame 12 into the frame opening 14 towards a center c of the frame opening 14. The first endocapsular arm 22a may also extend vertically relative to the frame 12 and / or the first plane pi. The first endocapsular arm 22a is configured to extend from the frame 12 towards the opening (i.e., capsulorhexis) of the capsular bag of an eye. The endocapsular arm(s) may not be designed to reach the center c of the frame opening 14 in order to not be in the line of sight of a patient when implanted.

[0087] As further depicted, in some embodiments, the first exocapsular arm 22b of the first spacer 22 extends outwardly from the first endocapsular arm 22a towards an outer perimeter Oi of the frame 12. The first exocapsular arm 22b also extends laterally and / or circumferentially around the frame 12 and away from the endocapsular arm 22a. The first exocapsular arm 22b may also extend vertically from the first endocapsular arm 22a. The first exocapsular arm 22b is configured to extend out of and / or away from the opening or capsulorhexis of the capsular bag of an eye.

[0088] As still further depicted, in some embodiments, the second endocapsular arm 24a of the second spacer 24 extends inwardly from a second location 11b of the capsular frame 12 into the frame opening 14 towards a center c of the frame opening 14. The second endocapsular arm 24a may also extend vertically relative to the frame 12 and / or the first plane pi. The second endocapsular arm 24a is configured to extend from the frame 12 towards the opening or capsulorhexis of the bag of an eye. The second location 11b of the second endocapsular arm24a may be located along any part of the frame 12.

[0089] As still further depicted, in some embodiments, the second exocapsular arm 24b of the second spacer 24 extends outwardly from the second endocapsular arm 24a towards an outer perimeter Oi of the frame 12. The second exocapsular arm 24b also extends laterally and / or circumferentially around the frame 12 and away from the second endocapsular arm 24a. The second exocapsular arm 24b may also extend vertically from the second endocapsular arm 24a. The second exocapsular arm 24b is configured to extend out of and / or away from the opening or capsulorhexis of the capsular bag of an eye.

[0090] In some embodiments, the first endocapsular arm 22a of the first spacer 22 (and / or the first location Ila on the frame 12) and the second endocapsular arm 24a of the second spacer 24 (and / or the second location 11b on the frame 12) are diametrically opposed along the frame 12.

[0091] As best shown in Fig. 2C, the first endocapsular arm 22a of the first spacer 22 may extend inwardly and vertically from the first location Ila of the frame 12 at a first arm angle aai relative to the frame 12 and / or first plane pi. The first arm angle aai ranges from 0 degrees to 60 degrees.

[0092] In some embodiments, the first arm angle aai ranges from 0.5 degrees to about 5 degrees. In some embodiments, the first arm angle aai ranges from 1 degree to about 2.5 degrees. In some embodiments, the first arm angle aai is 0 degrees and the endocapsular arm 22a extends along the first plane pi of the frame 12. The second endocapsular arm 24a of the second spacer 24 may display any of the same arm angles as the first endocapsular arm 22a. In some embodiments, the first and second endocapsular arms, 22a, 24a display the same arm angle.

[0093] The three-dimensional intraocular implants 10 described herein further include at least one exterior haptic 32, 34. The exterior haptics 32, 34 are designed to contact and / or extend into (i.e., dig into and grip) a tissue of the posterior chamber of the eye to secure the implant 10 in the eye. The exterior haptics 32, 34 are configured to secure the capsular frame 12 within the capsular bag of an eye from outside the capsular bag in the posterior chamber, and particularly the sulcus. The one or more exterior haptics 32, 34 are configured to extend away from the capsular bag, as well as the spacer 22, 24 (and / or the exocapsular arm 22b, 24b).

[0094] In some embodiments, the exterior haptics 32, 34 are sulcus haptics 32, 34 configured to contact and / or secure to the sulcus of an eye.

[0095] As further depicted in Figs. 2A-2D, the one or more exterior haptics 32, 34 extend between a fixed end part 32a, 34a which is fixed to one of the spacers 22, 24 and a free end part 32b, 34b which is free of rest of the implant 10 including the frame 12 and the spacers 22, 24. At least the free end part 32b, 34b of the haptics 32, 34 is curved (i.e., C-shaped) and may further include a friction-enhancing element, such as a plurality of ridges 31, 33, respectively. Other suitable friction-enhancing elements may be utilized. Some non-limiting examples include hooks, grips, pointed tips, and the like.

[0096] In some embodiments, the curved haptics 32, 34 extend from the spacer 22, 24 (and / or the exocapsular arm 22b, 24b) in the same direction, i.e., counter-clockwise (as shown) or clockwise.

[0097] As further depicted, in some embodiments, the curved haptics 32, 34 are also diametrically opposed around the frame 12 to define a haptic diameter and / or width d2 therebetween. The haptic diameter d2 is larger than the diameter of the frame opening di so although the transcapsular spacers 22, 24 are substantially, if not completely, positioned inside anouter perimeter Oi of the frame 12, the haptics 32, 34 are substantially, if not completely, positioned outside or beyond the outer perimeter Oi of the frame 12.

[0098] The haptics 32, 34, are also vertically spaced from the frame 12 by the spacers 22, 24 to define a height h of the implant 10. The height h of the implant 10 may range from about 0.05 mm to about 3 mm. In some embodiments, the height h of the implant 10 ranges from about 0.5 mm to about 2.5 mm. In some embodiments, the height h of the implant 10 ranges from about 1 mm to about 2 mm. In some embodiments, the height h of the implant 10 ranges from about 1.25 mm to about 1.75 mm. In some embodiments, the height h of the implant 10 is about 1.5 mm.

[0099] Turning now to Figs. 3A-13L, various additional intraocular implants of the present disclosure are depicted and described herein. Each of the additional implants are similar to the implant 10 of Figs. 1 A-2D and may include any combination of the various embodiments provided herein. Thus, the additional intraocular implants will be described herein to the extent necessary to identify differences in construction thereof. Throughout the present disclosure, like reference numerals (i.e., 10, 110, 210, 310, etc.) will be used to identify like elements in the various drawings and / or embodiments.

[0100] Figs. 3A-3D depict an intraocular implant 110 in accordance with another embodiment of the present disclosure which is generally designated as intraocular implant 110.

[0101] The intraocular implant 110 includes at least a capsular frame 112, a pair of transcapsular spacers 122, 124, and a pair of exterior haptics 132, 134. However, the radial gap angle ai is between 150 and 180 degrees, and particularly about 160 degrees. Such a gap angle ai reduces the overall size of the frame 112 which can render the frame 112 more easily deformable (i.e., folded, rolled, etc.) and / or easier to pass through the opening of the capsularbag for proper implantation. The reduced size of the frame 112 is designed to make the injection or placement of the frame 112 into the bag easier. The reduced size of the frame 112 may also reduce the amount of foreign matter introduced into the eye, and particularly the capsular bag, thereby reducing the likelihood of causing inflammation and / or irritation to the eye following implantation.

[0102] Figs. 4A-4E depict an intraocular implant in accordance with another embodiment of the present disclosure which is generally designated as intraocular implant 210.

[0103] The intraocular implant 210 includes at least a capsular frame 212, a pair of diametrically opposed transcapsular spacers 222, 224, and a pair of exterior haptics 232, 234. However, as shown best in Fig. 4E, the endocapsular arms 222a, 224a of the spacers 222, 224 extend along the first plane pi of the frame 212 and the arm angle aai of the endocapsular arms 222a, 224a is 0 degrees relative to the frame 212 and / or first plane pi. In addition, the thickness of the frame 212 represents between about 70% to 110% of the thickness of the endocapsular arm 222a, 224a. For example, in some embodiments, the thickness or diameter of the frame 212 is about 0.35mm and the thickness or diameter of the endocapsular arm 222a, 224a is about 0.5mm.

[0104] Figs. 5A-5D depict an intraocular implant in accordance with another embodiment of the present disclosure which is generally designated as intraocular implant 310.

[0105] The implant 310 includes at least an endocapsular frame 312, at least one pair of opposing transcapsular spacers 322, 324, and at least a pair of opposing exocapsular haptics 332, 334. However, in some embodiments, the implant 310 specifically includes two pairs of diametrically opposed transcapsular spacers 322, 324, and 326, 328, and four exterior haptics332, 334, 336, 338. Each of the spacers 322, 324, 326, 328 (and / or haptics 332, 334, 336, 338)are spaced laterally and / or circumferentially about 90 degrees apart from each other around the frame 312. Each of the four curved haptics 332, 334, 336, 338 extend from the spacer 322, 324, 326, 328, respectively, in the same direction, e.g., counter-clockwise direction (as shown) or clockwise direction. The radial gap angle ai of the implant 310 may also be less than about 60 degrees, such as about 45 degrees.

[0106] The additional symmetrically positioned transcapsular spacers 322, 324, 326, 328 and / or exterior haptics 332, 334, 336, 338 provide additional anchoring strength in the posterior chamber (and / or sulcus) and the anchoring strength may be more evenly distributed around the eye and / or sulcus.

[0107] Fig. 6 depicts an intraocular implant in accordance with yet another embodiment of the present disclosure which is generally designated as intraocular implant 410.

[0108] The implant 410 includes a frame 412 and a plurality (e.g., three) of spacers 422, 424, 426 each including at least one exterior haptic 432, 434, 436. The plurality of spacers 422, 424, 426 are not diametrically opposed to each other along the frame 412. At least one of the spacers 426 and the frame gap 413 may be diametrically opposed on the frame 412. The plurality of spacers 422, 424, 426 may or may not be symmetrically spaced around the frame 412.

[0109] Figs. 7A-7D depict an intraocular implant in accordance with yet another embodiment of the present disclosure which is generally designated as intraocular implant 510.

[0110] The implant 510 includes at least a capsular frame 512, a pair of transcapsular spacers 522, 524, and a pair of curved exterior haptics 532, 532’, and 534, 534’, extending from each spacer 522, 524. The first spacer 522 includes a first and second haptic 532, 532’ extending in opposite directions from the first spacer 522. For example, the first haptic 532 extends fromthe first spacer 522 in a direction towards the frame gap 513 (i.e., counterclockwise) and the second haptic 532’ extends from the first spacer 522 in a direction away from the frame gap 513(i.e., clockwise).

[0111] The second spacer 524 includes a third and fourth haptic 534, 534’ extending in opposite directions from the second spacer 524. For example, the third haptic 534 extends from the second spacer 524 in a direction away from the frame gap 513 (i.e., counterclockwise) and the fourth haptic 534’ extends from the second spacer 524 in a direction towards the frame gap 513 (i.e., clockwise).

[0112] Each of the four exterior haptics 532, 532’, 534, 534’ may define a curved or C- shaped body. The first and third exterior haptics 532, 534 extend from their respective spacer 522, 524, in a same counter clockwise first direction, while the second and fourth exterior haptics 532’, 534’, extend from their respective spacer 522, 524 in a same clockwise second direction. As further depicted, the four exterior haptics 532, 532’, 534, 534’ may collectively define an open hour-glass configuration including a haptic gap 535, 535’ on opposing ends of the implant 10.

[0113] Figs. 8A-8D depict an intraocular implant in accordance with yet another embodiment of the present disclosure which is generally designated as intraocular implant 610.

[0114] The implant 610 includes at least a capsular frame 612, a plurality of transcapsular spacers 622, 622’, 624, 624’, and a plurality of exterior haptics 632, 632’, 634, 634’. Each spacer 622, 622’, 624, 624’, includes a single haptic 632, 632’, 634, 634’, respectively. As depicted, the plurality of haptics 632, 632’, 634, 634’ collectively define an open hour-glass configuration including a haptic gap 635, 635’ on opposing ends of the implant 10 as depicted. As further depicted, the first and second spacers 622, 624, are diametricallyopposed on the frame 612 and the third and fourth spacers 622’, 624’, are diametrically opposed on the frame 612.

[0115] Figs. 9A-9D depict an intraocular implant in accordance with yet another embodiment of the present disclosure which is generally designated as intraocular implant 710.

[0116] The implant 710 includes at least a capsular frame 712, and a pair of transcapsular spacers 722, 724, each including one or more exterior haptics 732, 734. However, because the diameter di of the open frame ring 712 is smaller (i.e., less than 9 mm, such as about 7 mm) than a diameter of a capsular bag of an eye, the frame 712 may further include at least one interior (i.e., capsular or endocapsular) haptic 742, 744 to widen the implant 710 along the frame 712 and / or the first plane pi. The addition of the interior haptics 742, 744 aids the implant 710 in filling / flattening / tensioning the capsular bag after implantation. The width w of the endocapsular part of the implant 710 including the frame 712 and the interior haptics 742, 744 may range between 10mm to 15mm, and particularly about 13mm. As further depicted, the radial gap angle ai may be about 90 degrees.

[0117] As further depicted in Figs. 9A-9D, in some embodiments, each of the interior haptics 742, 744 define a curved or C-shaped body that extends outwardly from the frame 712 between a fixed end part 742a, 742b and a free end part 742b, 744b along the first plane pi. The exterior haptics 732, 734 may extend outwardly from their respective spacer 722, 724, and the interior haptics 742, 744 may extend outwardly from opposing sides of the frame 712 along the same counter-clockwise direction (or clockwise direction not shown). The exterior haptics 732, 734 and the interior haptics 742, 744 may not be vertically aligned. As further depicted, in some embodiments, the interior haptics 742, 744 are free of any friction-enhancing ridges.

[0118] As depicted, in some embodiments, the thickness or diameter of any of the interior and exterior haptics 742, 744, 732, 734 is greater than the thickness or diameter of the frame 712.

[0119] Figs. 10A-10H depict an intraocular implant in accordance with yet another embodiment of the present disclosure which is generally designated as intraocular implant 810.

[0120] The implant 810 includes at least a closed capsular frame or ring 812, and a pair of transcapsular spacers 822, 824, each including one or more interior haptics 842, 844 extending outwardly therefrom along the first plane pi of the frame and one or more exterior haptics 832, 834 extending outwardly therefrom along a parallel but vertically spaced second plane p2. The frame 812 defines a thickness or diameter greater than or equal to the thickness or diameter of the spacers 822, 824 and / or the various haptics 832, 834, 842, 844.

[0121] Figs. 11 A-l ID depict an intraocular implant in accordance with yet another embodiment of the present disclosure which is generally designated as intraocular implant 910.

[0122] The implant 910 includes at least a closed capsular frame 912 extending along a first plane pi and a pair of transcapsular spacers 922, 924, each including one or more exterior haptics 932, 934 extending outwardly therefrom along a parallel but vertically spaced second plane p2. The implant 910 further includes a pair of diametrically opposed closed loop interior haptics 942, 944 extending along the first plane pi. Instead of the curved and / or C-shaped interior haptics including a free end part positioned away from the frame as shown in Figs. 9A- 1 OH, the curved and / or C-shaped interior haptics 942, 944 extend between two fixed end parts 942a, 942b, 944a, 944b fixed to the frame 912 to form a closed loop interior haptic. A central part 942c, 944c of the closed loop interior haptic 942, 944 may be thicker than the fixed end parts 942a, 942b, 944a, 944b, as well as the frame 912.

[0123] Figs. 12A-12D depict an intraocular implant in accordance with yet another embodiment of the present disclosure which is generally designated as intraocular implant 1010.

[0124] The implant 1010 includes at least a closed capsular frame 1012 extending along a first plane pi and a pair of transcapsular spacers 1022, 1024, each including one or more exterior haptics 1032, 1034 extending therefrom. However, the exterior haptics 1032, 1034 are filaments and / or yarns which are thinner and more flexible than the spacers 1022, 1024. Unlike the various exterior haptics provided hereinabove which may be monolithic structures (e.g., bars, rods, arms) with the spacer and / or the frame, the filamentary haptics 1032, 1034 may be combined with the spacer 1022, 1024 after formation of the frame 1012 and spacers 1022, 1024. For example, each spacer 1022, 1024 includes a channel 1027, 1029 defined in at least the exocapsular arm 1022b, 1024b of the spacer. The spacer channel 1027, 1029 is configured to receive and maintain a first fixed end part 1032a, 1034a of the exterior haptic 1032, 1034 therein. The exterior haptic 1032, 1034 extends to a free end part 1032b, 1034b which may or may not include a friction-enhancing element. The filamentary exterior haptics may replace any of the exterior haptics described herein on any of the implants.

[0125] Figs. 13A-13L depict frames of additional non-limiting shapes suitable for incorporation to any of the various implants provided herein. For example, the implants may include a closed frame 1112’ or an open frame 1112” having a shape such as triangular (Figs. 13A-13B), rectangular (Figs. 13C-13D), hexagonal (Figs. 13E-13F), octagonal (Figs. 13G-13H), sinusoidal (Figs. 13I-13J), and / or trapezoidal (Figs. 13K-13L).

[0126] Fig. 14 depicts yet another intraocular implant as provided herein including one or more drugs, i.e., therapeutic agents. As depicted, the implant 1210 may include one or more zones Z1-Z7 including a drug that can be released from the implant during and / or followingimplantation. Some zones Z1-Z3 may be located on the frame 1212. Some zones Z4-Z5 may be located along the transcapsular arms 1222, 1224. Some zones Z6-Z7 may extend along the haptics 1232, 1234. Each of the zones T - A may have the same or different drugs. The one or more drugs may be designed to be immediately released, extended release, and / or sustain released. The implant may be designed to deliver an effective amount of the drug to the eye tissue.

[0127] Some non-limiting examples of suitable drugs include antibacterial agents, antibiotic agents, antiviral agents, analgesics, anesthetic agents, muscle relaxants, beta-blockers, alpha-agonists, anti-glaucoma agents, anti-fibrotic agent, anti-inflammatory agent, intraocular pressure lowering agents, immunosuppressant agent, anti-neoplastic agent, migration inhibitors, anti-proliferative agent, antihistamines, mydriatics, cholinergic agonists, alpha-receptor blocker, diagnostic agents, tissue adhesive agent, tissue anti-adhesive agents, and combinations thereof.

[0128] The drugs may be applied to the implant using any suitable method including processes such as dip-coating, brushing, painting, extrusion, molding, spraying, ultrasonics, and combinations thereof.

[0129] Fig. 15 depicts yet another embodiment wherein the implant 1310 is combined with an artificial capsular bag 1390. As depicted, the artificial capsular bag 1390 may be attached to the capsular frame 1312 and at least a portion of the transcapsular arms 1322, 1324 to form a cavity 1391 therein with implant 1310 partially positioned therein and the exterior haptics 1332, 1334 extending from the bag 1390 for placement into the posterior chamber of the eye and / or sulcus.

[0130] The artificial capsular bag 1390 is essentially a polymeric film that is typically thinner than the framed implant 1310 and may be particularly useful for treating capsularrupture. During eye surgery, such as cataract surgery, a patient’s capsular bag may rupture allowing vitreous fluid to flow towards the anterior of the eye and making proper placement of an intraocular lens difficult. In some embodiments, the implants described herein may further include an artificial capsular bag 1390 for the treatment of capsular rupture. The artificial bag 1390 creates a defined cavity 1391 for the proper placement and retainment of an intraocular lens 1392 therein. The artificial bag may also be designed to block or prevent the flow of vitreous fluid beyond the implant or lens.

[0131] The artificial bag may be fabricated using any one of a number of available biocompatible materials including biopolymers including collagen, laminin, keratin, and the like, or polymeric materials such as polymethyl methacrylate, hydroxy ethyl methacrylate (HEMA), styrene polymers, polyolefins, silicon, hydrophobic or hydrophilic acrylic materials and the like. The artificial capsular bag may be manufactured and combined with the framed implant using any suitable method including but not limited to extrusion, casting, blowing, molding, spraying, shrink-wrapping, gluing, stitching, welding, and the like. In some embodiments, the artificial capsular bag is made of a polyolefin such as polyethylene and / or polypropylene and the bag may be shrink-wrapped to the framed implant. In some embodiments, the artificial bag may display adhesive electrostatic properties.

[0132] The frame, the spacer, the exterior haptics, and / or the interior haptics may be made from any suitable biocompatible polymeric material or any other materials commonly used for manufacturing intraocular lenses and / or intraocular implants. The material may be transparent. Some non-limiting examples of suitable polymeric materials include silicone or acrylic based polymer materials and / or poly(methyl methacrylate). The frame, the spacer, theexterior haptics, and / or the interior haptics may be made from the same or different biocompatible polymeric material.

[0133] The implants provided herein are designed to be deformable and / or foldable during insertion into the eye (and / or capsular bag) and return to a non-deformable original three- dimensional shape following insertion into inside the eye (and / or capsular bag). Thus, each of the frame, the spacer, the exterior haptics, and / or the interior haptics may display an elasticity suitable for deformation (and / or folding) and a resiliency to return to the original three- dimensional shape. In some embodiments, the implant is made of a shape-memory material or thermal reactive material.

[0134] In some embodiments, the frame are more elastic than the spacer and / or the haptics, and particularly exterior haptics.

[0135] In some embodiments, the haptics are more elastic than the spacer and / or the frame, and particularly the exterior haptics.

[0136] In some embodiments, the frame and the haptics (e.g., exterior and interior haptics) are more elastic than the spacer.

[0137] The intraocular implants provided herein may be made using any suitable manner. Some non-limiting example of suitable manners include molding, extruding, pressing, stamping, laser etching, 3D-printing, and combinations thereof.

[0138] In some embodiments, the implants provided herein may be made of a single monolithic structure.

[0139] In some embodiments, the implants provided herein may be made of multiple different pieces.

[0140] The intraocular implants provided herein may be sterile or non-sterile implants.Any suitable sterilization process may be used to sterilize the implants.

[0141] The intraocular implants provided herein may be used in methods of treating a variety of eye diseases, including but not limited to, lens dislocation, pseudoexfoliation syndrome, cataracts, zonular laxity, zonular failure, capsular bag instability and combinations thereof. The intraocular implants provided herein may also be used prophylactically to aid in preventing a variety of eye diseases including but not limited to lens dislocation, pseudoexfoliation syndrome, cataracts, zonular laxity, zonular failure, capsular bag instability, capsular rupture, and combinations thereof.

[0142] In some embodiments, the methods of treatment and / or prophylaxis include the steps of deforming (i.e., folding, rolling) an intraocular implant as provided herein (i.e., including at least a capsular frame, one or more transcapsular arms, and one or more exterior haptics), and implanting the deformed intraocular implant into an eye of a patient such that the capsular frame (with or without interior haptics) in a deformed shape of reduced size is passed through an opening (capsulorhexis) in a capsular bag of the patient while the exterior haptics remain exterior the capsular bag. After inserting the capsular frame into the capsular bag, the implant is allowed to return to its original non-deformed three-dimensional configuration with the capsular frame being positioned within the capsular bag, the transcapsular arms extending out of the capsular bag, and the exterior haptics extending into the posterior chamber of the eye, particularly the sulcus. Although the implant is designed to not need any additional fixation, in some embodiments, the methods may further include fixing the implant to the eye via suturing, adhesive, stapling, etc. In some embodiments, the methods may further include implanting an intraocular lens into the capsular bag and / or eye. The intraocular lens may be positionedposteriorly or anteriorly to the three-dimensional framed implant. In some embodiments, the intraocular implant may be injected into the eye and / or capsular bag.

[0143] In some embodiments, the intraocular implant may include an artificial capsular bag attached thereto and the instead of passing the implant through a capsulorhexis, the implant may be passed into the eye to completely replace the capsular bag. This may be particularly useful in treating capsular rupture.

[0144] The use of the term “about” herein is intended to encompass a given number ±10%. In some embodiments, the term “about” is intended to encompass a given number ±5%.

[0145] All ranges provided herein are intended to be inclusive and are further intended to represent any combination of numbers identified in the range individually or collectively in any sub-combination within the range.

[0146] While several embodiments of the disclosure have been shown in the drawings, it is not intended that the disclosure be limited thereto, as it is intended that the disclosure be as broad in scope as the art will allow and that the specification be read likewise. Therefore, the above description should not be construed as limiting, but merely as exemplification of embodiments. Those skilled in the art will envision other modifications within the scope and spirit of the claims appended hereto.

Claims

CLAIMSWhat is claimed is:

1. An intraocular implant comprising: a capsular frame configured to be positioned with a capsular bag of an eye, the capsular frame defining a frame opening and extending along a first plane; one or more transcapsular spacers extending between an endocapsular arm and an exocapsular arm, the endocapsular arm extending inwardly from a first location of the capsular frame towards a center of the frame opening and the exocapsular arm extending outwardly from the endocapsular arm, the endocapsular arm configured to extend towards an opening in the capsular bag and the exocapsular arm configured to extend away from the opening in the capsular bag and out of the capsular bag, one or more exterior haptics extending from the exocapsular arm, the one or more exterior haptics configured to contact a sulcus of the eye to secure the implant in the eye and / or secure the capsular frame in the capsular bag.

2. The intraocular implant of claim 1, wherein the capsular frame is an open capsular frame including opposing frame ends spaced apart by a frame gap.

3. The intraocular implant of claims 1 or 2, wherein: the one or more transcapsular spacers includes a plurality of transcapsular spacers positioned symmetrically around the capsular frame; and the one or more exterior haptics includes a plurality of exterior haptics.

4. The intraocular implant of claim 3, wherein the plurality of transcapsular spacers includes at least a first pair of transcapsular spacers, the first pair including a first transcapsular spacer and a second transcapsular spacer positioned on diametrically opposite sides of the capsular frame.

5. The intraocular implant of claim 4, wherein the plurality of exterior haptics includes a first exterior haptic extending from a first exocapsular arm of the first transcapsular spacer and a second exterior haptic extending from a second exocapsular arm of the second transcapsular spacer, wherein the first and second exterior haptics are curved exterior haptics extending around the frame in the same clockwise or counter-clockwise direction.

6. The intraocular implant of claim 4, wherein the plurality of exterior haptics includes a first exterior haptic and a second exterior haptic extending from a first exocapsular arm of the first transcapsular spacer and a third exterior haptic and a fourth exterior haptic extending from a second exocapsular arm of the second transcapsular spacer, wherein the first and third exterior haptics are curved exterior haptics extending around the frame in the same counter-clockwise direction and the second and fourth exterior haptics are curved haptics extending around the frame in the same clockwise direction.

7. The intraocular implant of claim 6, wherein the first, second, third, and fourth exterior haptics collectively define an open hourglass configuration including a haptic gap on each of the opposing ends of the implant.

8. The intraocular implant of claim 4, wherein the plurality of transcapsular spacers further includes a third transcapsular spacer positioned diametrically opposite the frame gap.

9. The intraocular implant of claim 5, wherein the plurality of transcapsular spacers further includes at least a second pair of transcapsular spacers, the second pair including a third transcapsular spacer and a fourth transcapsular spacer positioned on diametrically opposite sides of the capsular frame.

10. The intraocular implant of claim 9, wherein the plurality of exterior haptics further includes a third exterior haptic extending from a third exocapsular arm of the third transcapsular spacer, and a fourth exterior haptic extending from a fourth exocapsular arm of the fourth transcapsular spacer, wherein: the third and fourth exterior haptics are curved exterior haptics extending around the frame in the same clockwise or counter-clockwise as the first and second exterior haptics; or, the third and fourth exterior haptics are curved exterior haptics extending around the frame in a clockwise or counter-clockwise opposite the first and second exterior haptics.

11. The intraocular implant of claim 1, wherein the capsular frame is a closed capsular frame including one or more interior haptics extending therefrom, the interior haptics configured to remain in the capsular bag upon implantation.

12. The intraocular implant of claim 11, wherein the one or more interior haptics include a closed loop configuration.

13. The intraocular implant of claims 11 or 12, wherein the capsular frame, the one or more interior haptics, and the one or more transcapsular arms define a monolithic structure and the one or more exterior haptics includes a curved filamentary haptic combined with the monolithic structure.

14. The intraocular implant of any of the preceding claims, further comprising one or more drugs.

15. The intraocular implant of any of the preceding claims, further comprising an artificial capsular bag connected to at least one of the capsular frame or the one or more transcapsular arms.

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