Intraocular lens design for improving stability

Abstract

An intraocular lens (IOL) (300) improves lens stability by, for example, increasing the anterior-posterior stiffness of the IOL, increasing the anterior-posterior dimensions of the IOL, and / or increasing the contact area with the mid-meridian of the capsular bag to resist movement of the IOL as the capsular bag collapses over time. These IOLs can be non-modular (single-piece) or modular (multi-piece). In modular embodiments, the IOL system can include an intraocular base and an optical component that together form a modular IOL when combined.

Description

[0001] (Division of 201780027303.4)

[0002] Cross - Reference to Related Applications

[0003] 01 This application claims the benefit of priority of U.S. Provisional Patent Application No. 62 / 332,163, filed May 5, 2016, entitled "INTRAOCULAR LENS DESIGNS FOR IMPROVED STABILITY", under 35 U.S.C. § 119(e), the entire disclosure of which is incorporated herein by reference.

[0004] 02 This application is related to U.S. Patent Application No. 15 / 342,806, filed on November 3, 2016, titled "MODULAR INTROCULAR LENS DESIGNS, TOOLS AND METHODS"; U.S. Patent Application No. 15 / 218,658, filed on July 25, 2016, titled "MODULARINTROCULAR LENS DESIGNS, TOOLS AND METHODS"; U.S. Patent Application No. 15 / 176,582, filed on June 8, 2016, titled "MODULAR INTROCULAR LENSDESIGNS, TOOLS AND METHODS"; U.S. Patent Application No. 15 / 150,360 (now U.S. Patent No. 9,421,088), filed on May 9, 2016, titled "MODULAR INTROCULAR LENS DESIGNS, TOOLS ANDMETHODS"; U.S. Provisional Patent Application No. 62 / 332,163, filed on May 5, 2016, titled "INTRAOCULAR LENS DESIGNS FOR IMPROVEDSTABILITY"; U.S. Provisional Patent Application No. 62 / 318,272, filed on April 5, 2016, titled "MODULAR INTROCULAR LENS DESIGNS, TOOLS AND METHODS"; U.S. Patent Application No. 15 / 054,915, filed on February 26, 2016, titled "MODULAR INTROCULAR LENS DESIGNS, TOOLS AND METHODS"; U.S. Provisional Patent Application No. 62 / 256,579, filed on November 17, 2015, titled "MODULARINTROCULAR LENS DESIGNS, TOOLS AND METHODS"; U.S. Provisional Patent Application No. 62 / 250, filed on November 4, 2015, titled "MODULAR INTROCULARLENS DESIGNS, TOOLS AND METHODS"780. U.S. Patent Application No. 14 / 828,083, filed on August 17, 2015, titled "MODULAR INTROCULAR LENS DESIGNS, TOOLS AND METHODS" (now U.S. Patent No. 9,364,316); U.S. Patent Application No. 14 / 808,022, filed on July 24, 2015, titled "MODULAR INTROCULAR LENSDESIGNS AND METHODS" (now U.S. Patent No. 9,387,069); U.S. Provisional Patent Application No. 62 / 110,241, filed on January 30, 2015, titled "MODULAR INTROCULAR LENSDESIGNS, TOOLS AND METHODS"; U.S. Patent Application No. 14 / 610,360, filed on January 30, 2015, titled "MODULAR INTROCULAR LENS DESIGNS, TOOLSAND METHODS"; U.S. Provisional Patent Application No. 61 / 941,167, filed on February 18, 2014, titled "MODULAR INTROCULAR LENS DESIGNS, TOOLS AND METHODS"; U.S. Patent Application No. 13 / 969,115, filed on August 16, 2013, titled "MODULAR INTRAOCULAR LENS DESIGNS&METHODS" (now U.S. Patent No. 9,289,287); U.S. Patent Application No. 13 / 937,761, filed on July 9, 2013, titled "MODULAR INTRAOCULAR LENS DESIGNS AND METHODS" (now U.S. Patent No. 9,125,736); U.S. Provisional Patent Application No. 61 / 830,491, filed on June 3, 2013, titled "MODULAR INTRAOCULAR LENS DESIGNS AND METHODS"; U.S. Patent Application No. 13 / 748,207, filed on January 23, 2013, titled "MODULAR INTRAOCULARLENS DESIGNS&METHODS" (now U.S. Patent No. 9,095,U.S. Provisional Patent Application No. 61 / 589,981, filed on January 24, 2012, titled "LASER ETCHING OF IN SITU INTRAOCULAR LENS AND SUCCESSIVE SECONDARY LENS IMPLANTATION", and U.S. Provisional Patent Application No. 61 / 677,213, filed on July 30, 2012, titled "MODULAR INTRAOCULAR LENS DESIGNS & METHODS", are each incorporated herein by reference in their entirety., FIELD OF THE DISCLOSURE

[0005] 03 This disclosure generally relates to intraocular lenses (IOLs). More specifically, this disclosure relates to embodiments of IOL designs for improving stability within the capsular bag. BACKGROUND OF THE DISCLOSURE

[0006] 04 The human eye functions to provide vision by allowing light to pass through a transparent outer portion called the cornea and focusing an image onto the retina with the aid of the lens. The quality of the focused image depends on many factors, including the size and shape of the eye and the transparency of the cornea and lens.

[0007] 05 When age or disease causes the lens to become less transparent (e.g., cloudy), vision deteriorates because less light can pass through to the retina. This defect in the eye's lens is medically known as a cataract. The treatment for this condition is to surgically remove the lens from the capsular bag and place an intraocular lens (IOL) within the capsular bag. In the United States, most cataract lenses are removed by a surgical technique called phacoemulsification. During this procedure, an opening (capsulotomy) is created in the front side of the capsular bag, and a thin phacoemulsification tip is inserted into the diseased lens and ultrasonically vibrated. The vibrating tip liquefies or emulsifies the lens so that it can be aspirated from the capsular bag. Once the diseased lens is removed, it is replaced with an IOL.

[0008] 06 After implantation of an IOL in cataract surgery, the optical results may not be ideal. For example, shortly after surgery, it may be determined that the refractive correction is incorrect, resulting in what is sometimes referred to as a "refractive surprise". This may be caused in part by the postoperative movement of the IOL within the capsular bag. The effective lens position (ELP), typically measured using Scheimpflug photography (e.g., Pentacam by Oculus, Germany), is a measurement of the anterior-posterior distance from the anterior surface of the cornea to the anterior surface of the lens (also known as the anterior chamber depth or ACD). The ELP can change significantly postoperatively, where a 1.0 mm shift in the ELP corresponds to a 3.0 diopter change in visual acuity. Therefore, a more stable IOL postoperatively is needed to reduce the change in ELP and reduce refractive surprises. Summary of the Invention

[0009] 07 Embodiments of the present disclosure provide IOLs that improve ELP stability by, for example, increasing the anterior-posterior stiffness of the IOL, increasing the anterior-posterior dimensions of the IOL, and / or increasing the contact area with the mid-periphery of the capsular bag to resist movement of the IOL as the capsular bag collapses over time. These IOLs can be non-modular, integral, or monolithic (i.e., a single piece) or modular (multiple pieces). In modular embodiments, the IOL system can include an intraocular base and an optical component that, when combined, form a modular IOL.

[0010] 08 In one embodiment, the modular IOL includes an annular base having two radially outwardly extending haptics. The base can define a central aperture and an inner perimeter, where radially inwardly opening recesses surround the inner perimeter. The modular IOL system also includes a lens having an optical body with a first tab and a second tab extending radially outwardly from the optical body. The base and the lens can be assembled together, where the first tab and the second tab of the lens are disposed within the recesses of the base. The base can have an anterior-posterior dimension greater than that of the lens to increase the anterior-posterior stiffness of the assembly. The base can also have an anterior-posterior dimension approximately the same as the anterior-posterior dimension within the capsular bag (i.e., between the lobules of the capsular bag) to reduce anterior-posterior displacement within the capsular bag.

[0011] 09 In another embodiment, the modular IOL includes a base configured to receive a conventional lens. The base can be annular, having a central aperture, two radially outwardly extending haptics, and an internal protrusion for receiving a conventional lens having haptics. The base and the lens can be assembled together, where the perimeter of the lens rests on the protrusion of the base, and the haptics of the lens extend through slots in the base. Similar to other embodiments described herein, the base can have an anterior-posterior dimension greater than that of the lens to increase the anterior-posterior stiffness of the assembly. Additionally, the base can also have an anterior-posterior dimension approximate to the anterior-posterior dimension inside the capsular bag (i.e., between the leaflets of the capsular bag) for reducing anterior-posterior displacement in the capsular bag.

[0012] 10 In yet another embodiment, the non-modular IOL includes an enlarged annular rim around the optic for increasing anterior-posterior stiffness. The enlarged annular rim can have an anterior-posterior dimension approximate to the anterior-posterior dimension inside the capsular bag (i.e., between the leaflets of the capsular bag). A gap in the rim can be used to enable folding for delivery via a syringe. The rim can extend radially outward to form a buttress between the optic and the haptics extending therefrom.

[0013] 11 The IOL according to an embodiment of the present disclosure can be applied to various IOL types, including fixed monofocal, multifocal, toric, accommodative, and combinations thereof. Additionally, the IOL according to an embodiment of the present disclosure can be used to treat, for example, cataracts, large optical errors in myopic eyes (nearsighted eyes), hyperopic eyes (farsighted eyes), and astigmatism, lens subluxation, aphakia, pseudophakia, and nuclear sclerosis.

[0014] 12 Various other aspects and advantages of embodiments of the present disclosure are described in the following detailed description and the drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0015] 13 The drawings illustrate exemplary embodiments of the present disclosure. The drawings are not necessarily to scale, may include like elements numbered the same, and may include dimensions (in millimeters) and angles (in degrees) that are by way of example and not necessarily limiting. In the drawings:

[0016] 14 Figure 1 is a schematic view of a human eye shown in cross-section;

[0017] 15 Figure 2 is a schematic view of a lens of a human eye shown in sagittal cross-section;

[0018] 16 Figure 3A is a perspective view of a modular IOL according to the present disclosure;

[0019] 17 Figure 3B is toFigure 3A Graph of the results of bench tests comparing the performance of the modular IOL shown with that of commercially available IOLs;

[0020] 18 Figures 4A to 4D Respectively Figure 3A Perspective view, top view, sectional view, and detailed view of the base of the modular IOL shown;

[0021] 19 Figures 5A to 5E Respectively Figure 3A Perspective view, top view, sectional view, and detailed view of the lens of the modular IOL shown;

[0022] 20 Figure 6A And Figure 6B Perspective view and sectional view of an alternative modular IOL according to the present disclosure;

[0023] 21 Figures 7A to 7B Perspective view of an alternative base for use with a conventional IOL according to the present disclosure;

[0024] 22 Figures 8A to 8C Perspective view, sectional view, and top view of a non-modular IOL according to the present disclosure;

[0025] 23 Figure 9A And Figure 9B Perspective view of an alternative non-modular IOL according to the present disclosure;

[0026] 24 Figure 10A And Figure 10B Top view and sectional view of another alternative non-modular IOL according to the present disclosure;

[0027] 25 Figure 11A And Figure 11B Top view and sectional view of yet another alternative non-modular IOL according to the present disclosure;

[0028] 26 Figure 12A And Figure 12B Top view and sectional view of another alternative non-modular IOL according to the present disclosure; and

[0029] 27 Figures 13A to 13C Perspective view of various alternative non-modular IOLs according to the present disclosure. Detailed Description

[0030] 28 Reference will now be made in detail to examples of the present disclosure shown in the accompanying drawings. Wherever possible, the same reference numerals are used throughout the drawings to refer to the same or like parts. In the following discussion, unless otherwise indicated, relative terms such as "about", "substantially", "approximately", etc. are used to indicate a possible variation of ±10% of the stated value, number, or other.

[0031] 29 Referring to Figure 1 , the human eye 10 is shown in cross-section. For various purposes, the eye 10 is described as an organ that responds to light. As a conscious sensory organ, the eye produces vision. Rod and cone cells in the retina 24 produce conscious light perception and vision, including color discrimination and depth perception. In addition, non-imaging photosensitive ganglion cells in the human eye receive light signals in the retina 24, and these light signals affect the adjustment of pupil size, the regulation and inhibition of the hormone melatonin, and the cyclic changes of the biological clock.

[0032] 30 The eye 10 is not a strictly spherical body; rather, it is a fused two-piece unit. The smaller anterior unit with a greater curvature, called the cornea 12, is connected to the larger unit called the sclera 14. The radius of the corneal segment 12 is typically about 8 mm (0.3 inches). The sclera 14 constitutes the remaining five-sixths; its radius is typically about 12 mm. The cornea 12 and the sclera 14 are connected by a ring called the limbus. Since the cornea 12 is transparent, the iris 16, the color of the eye and its black center, the pupil, can be seen, rather than the cornea 12. To see inside the eye 10, an ophthalmoscope is needed because light is not reflected out. The fundus (the area opposite the pupil), including the macula 28, shows a characteristic pale optic disc (papilla), through which the blood vessels entering the eye pass, and the optic nerve fibers 18 leave the eyeball.

[0033] 31 Thus, the eye 10 is composed of three membranes that enclose three transparent structures. The outermost layer consists of the cornea 12 and the sclera 14. The middle layer consists of the choroid 20, the ciliary body 22, and the iris 16. The innermost layer is the retina 24, and the retina is circulated by the blood vessels of the choroid 20 and the retinal blood vessels that can be seen inside the ophthalmoscope. Inside these membranes, there is aqueous humor, vitreous humor 26, and a flexible lens 30. Aqueous humor is a transparent liquid and is contained in two regions: the anterior chamber between the cornea 12 and the exposed area of the iris 16 and the lens 30; and the posterior chamber between the iris 16 and the lens 30. The lens 30 is suspended from the ciliary body 22 by the ciliary zonule 32 (zonula of Zinn), which is composed of fine transparent fibers. The vitreous humor 26 is a much larger transparent gel-like body than the aqueous humor.

[0034] The 32 lens 30 is a transparent biconvex structure in the eye that, together with the cornea 12, helps refract light so that it focuses on the retina 24. The lens 30 functions to change the focal length of the eye by changing its shape, allowing the eye to focus on objects at various distances and thus permitting a clear, real image of the object of interest to be formed on the retina 24. This adjustment of the lens 30 is called accommodation and is analogous to a camera focusing by moving its lens.

[0035] 33 The lens has three main parts: the lens capsule, the lens epithelium, and the lens fibers. The lens capsule forms the outermost layer of the lens, while the lens fibers form most of the interior of the lens. The lens epithelial cells, located between the lens capsule and the outermost layer of the lens fibers, are mainly present on the anterior side of the lens but extend posteriorly just beyond the equator.

[0036] 34 The lens capsule is a smooth, transparent basement membrane that completely surrounds the lens. The capsule is elastic and is composed of collagen. Collagen is synthesized by the lens epithelial cells, and its main components are type IV collagen and sulfated glycosaminoglycans (GAGs). The capsule is very elastic and thus causes the lens to assume a more spherical shape when not under the tension of the zonular fibers that connect the lens capsule to the ciliary body 22. The thickness of the capsule varies between about 2 and 28 micrometers, being thickest near the equator and thinnest near the posterior pole. The anterior curvature involved with the lens capsule can be greater than the posterior curvature of the lens.

[0037] 35 Various diseases and disorders of the lens 30 can be treated with an IOL. By way of example and without limitation, an IOL according to embodiments of the present disclosure can be used to treat cataracts, large optical errors in myopic (nearsighted) eyes, hyperopic (farsighted) eyes, and astigmatic eyes, lens dislocation, aphakia, pseudophakia, and nuclear sclerosis. However, for purposes of description, the IOL embodiments of the present disclosure are described with reference to cataracts, which commonly occur in the elderly population.

[0038] 36 As Figure 2 shown, the shape of the lens 30 is generally symmetric about the visual axis 37. However, the lens 30 is not symmetric about the sagittal plane 39. Instead, the radius of curvature (R A ) of the anterior side 33 of the lens 30 is greater than the radius of curvature (R P ) of the posterior side 35. The equatorial diameter (D) is more anterior, where the posterior lens thickness (T P ) is greater than the anterior lens thickness (T A ).

[0039] 37 Data published by Rosen et al. (2006) indicate that the equatorial diameter D, the posterior lens thickness T P, the anterior lens thickness T A and the anterior radius of curvature R A vary with age, while the posterior radius of curvature R P and the ratio T A / T P remain constant. Rosen et al. described the following age-related equations for these parameters (all in mm) using best-fit linear equations:

[0040] 38 D = 0.0138 (±0.002) * age + 8.7 (±0.14) (R 2 = 0.57; p < 0.0001);

[0041] 39 T A = 0.0049 (±0.001) * age + 1.65 (±0.075) (R 2 = 0.45; p < 0.0001);

[0042] 40 T P = 0.0074 (±0.002) * age + 2.33 (±0.11) (R 2 = 0.44; p < 0.0001);

[0043] 41 R A = 0.046 (±0.017) * age + 7.5 (±1.13) (R 2 = 0.27; p = 0.016);

[0044] 42 R P = -5.5 (±0.9); and

[0045] 43 T A / T P = 0.70 (±0.13).

[0046] 44 As an example and not a limitation, these data or other empirically measured data can be used to describe the shape and size of the lens for a specific age group, such as cataracts in elderly patients with an average age of 70 years. These data can be used to determine the available space for an intraocular implant to be placed in the capsular bag. For example, assume that an eye implant (such as an IOL) will be centered in the mid-meridian plane, where the anterior-posterior height "H" is at a radial distance "X" from its center point. Also assume that it is desired to have the anterior and posterior sides of the implant contact the wall of the capsular bag at the radial distance X to reduce implant migration. Mathematical modeling can be used to determine the height (H) of the lens capsule at any given radial distance (X) along the mid-meridian plane at 37 from the visual axis.

[0047] 45 The total height H is equal to the anterior height (H A) and the posterior height (H P ). The sum of the anterior height (H A ) can be given by the equation H A = Y - (R A - T A ). Although R A and T A are known empirically, the distance (Y) from the mid - latitude plane can be given by the equation Y = (R A 2 - X 2 ). Combining these equations, the anterior height can be given by H A = (R A 2 - X 2 )^0.5 - (R A - T A ) and solved using empirical data. The posterior height (H P ) can be calculated similarly using the posterior radius (R P ) and the posterior thickness (T P ) and solved using empirical data. Adding the posterior height (H P ) to the anterior height (H A ) provides the total height (H) at the distance (X) from the visual axis. Thus, the desired height (H) of the intra - ocular implant at the radial distance X can be estimated such that the implant contacts the anterior and posterior walls of the capsular bag. Alternative mathematical models described in the literature can also be used.

[0048] 46 The following detailed description describes various embodiments of modular and non - modular IOL systems. Features described with reference to any one embodiment can be applied to other embodiments and incorporated into other embodiments.

[0049] 47 Referring to Figure 3A , the base 400 and the lens 500 form an embodiment of the modular IOL 300 when assembled. A general description of the modular IOL 300 is subsequently provided, and further detailed description is provided in U.S. Provisional Patent Application No. 62 / 318,272, which is hereby incorporated by reference in its entirety.

[0050] 48 Referring to Figures 4A to 4D , the base 400 is shown in more detail. Figure 4A is a perspective view, Figure 4B is a top view, Figure 4C is a cross - sectional view taken along line A - A in Figure 4B , and Figure 4D is a detailed cross - sectional view of circle C in Figure 4C . Dimensions (mm) are given as examples and are not necessarily limiting.

[0051] 49 The base 400 includes an annular ring 402 that defines a central aperture 404. A pair of loops 406 extend radially outward from the annular ring 402. The annular ring 402 includes a lower edge 408, an upper edge 410, and an inwardly facing recess 412 into which the lens 500 can be inserted to form the modular IOL 300.

[0052] 50 The upper edge 410 of the annular ring 402 may include one or more notches 416 to provide access for a probe (such as a Sinskey hook) during surgery, which allows for easier manipulation of the base 400. For the same purpose as the notch 416, the loop 406 may include a hole 415 adjacent to the annular ring 402. A pair of square edges 417 may extend around the posterior perimeter of the annular ring 402 to help reduce cell proliferation (posterior capsular opacification or PCO) on the lens 500.

[0053] 51 Specifically referring to Figure 4D , the deep portion of the recess 412 may have a square profile defined by a horizontal posterior surface 418, a horizontal anterior surface 420, and vertical side or outer surfaces 422. The recess may also include an opening anterior surface 426 that extends radially inward and forwardly outward from the horizontal anterior surface 420 and an opening posterior surface 428 that extends radially inward and rearwardly outward from the horizontal posterior surface 418. The inner diameter of the posterior edge 408 may be less than the inner diameter of the anterior edge 410. With this arrangement, the lens 500 can be placed through the circular opening defined by the anterior edge 410 to rest or sit on the posterior edge, and the opening anterior wall 426 together with the opening posterior wall 428 can act as a funnel to guide the tabs 504 and 506 of the lens 500 into the deep portion of the recess 412. When fully located within the recess 412, the horizontal posterior wall 418, the horizontal anterior wall 420, and the vertical side walls 422 form a keyed geometry with the corresponding horizontal and vertical sides of the tabs 504 and 506 to restrict movement of the lens 500 relative to the base 400 in the forward, backward, and radial directions.

[0054] 52 As best seen in Figure 4D , the base 400 may have an anterior - posterior height of H = H A +H P , where H is approximately 1 mm, H A is approximately 0.5 mm at a radial distance of approximately 3.2 mm from the center point CP, and H P is approximately 0.5 mm at a radial distance of approximately 2.65 mm from the center point CP. However, as previously mentioned, the posterior thickness T P of the native lens 30 is greater than the anterior thickness T A of the native lens 30. P . Therefore, these relative dimensions can be adjusted. For example, H P can be made greater than HA such that when the modular IOL 300 is implanted in the capsular bag, the sagittal midplane MP of the base 400 is aligned with the mid-equatorial plane of the lens 30 (+ / -0.5 mm). For example, the ratio H A / H P may be constant at approximately 0.7 (±0.3). Additionally, H may be selected such that when implanted in the capsular bag, the foremost portion of the anterior edge 410 is in close proximity (within 0.5 mm) to the anterior side 33 of the lens 30, and the rearmost portion of the posterior edge 408 is in close proximity (within 0.5 mm) to the posterior side 35 of the lens 30. Thus, by way of example and not limitation, for instance, H A may be approximately 0.5 mm to 1.0 mm at a radial distance of approximately 2.75 mm to 3.25 mm from the center point CP, and H P may be approximately 0.75 mm to 1.5 mm at a radial distance of 2.25 mm to 2.50 mm from the center point CP2, for example, thereby maintaining a constant ratio H A / H P .

[0055] 53 Reference Figures 5A to 5E more particularly shows the lens 500. Figure 5A is a perspective view, Figure 5B is a top view, Figure 5C is a cross-sectional view taken along Figure 5B line A-A in Figure 5D is Figure 5C a detailed cross-sectional view of circle B in Figure 5E and Figure 5B is a detailed top view of circle C in

[0056] 54 The lens 500 may include an optical portion 502 and one or more tabs 504 and 506. As shown, tab 504 is fixed while tab 506 may be actuated. The fixed tab 504 may include a through-hole 208 such that a probe (e.g., a Sinskey hook) or similar device may be used to engage the hole 208 and manipulate the tab 504. The actuatable tab 506 may be actuated between a compressed position for delivery into the hole 404 in the base 400 and an uncompressed extended position for deployment into the recess 412 in the base 400 (as shown), thereby forming an interlocking connection between the base 400 and the lens 500. It is also contemplated that the actuatable tab 506 may be inserted into the recess 412 and may be actuated between a compressed position (to facilitate entry of the fixed tab 504 into the recess 412) and an uncompressed extended position (to further insert the fixed tab 504 into the recess 412) to form an interlocking connection between the base 400 and the lens 500.

[0057] The actuatable tab 506 can include two members 510 and 512, with one end of each member connected to the edge of the optical device 502 and the other end free, thus forming two cantilever springs. The edge 514 can extend around the perimeter of the optical device 502 to terminate the bounce of the springs 510 and 512, thereby enabling the springs 510 and 512 to be fully compressed against the edge of the optical device 502. The edge 514 of the lens 500 can have an outer diameter larger than the inner diameter of the rear edge 408 of the base 400, such that the lens 500 does not fall into the opening 404 of the base 400 and such that the lens 500 is circumferentially supported around its perimeter by the rear edge 408 of the base 400. A gusset having a guide hole 516 can be provided between the two members 510 and 512 to facilitate manipulation by a probe. Similarly, a guide hole 508 can be provided in the fixed tab 504 to provide access for a probe (such as a Sinskey hook) or similar device to manipulate the fixed tab 504 into the recess 412 in the base 400. A notch 518 can be provided in the fixed tab 504 to provide asymmetry as a visual indication that the front side is upward (instead of downward) when the notch is counterclockwise to the hole 508. 56 As Figure 5C seen, the front and rear sides of the optical device 502 can have convex radii corresponding to the desired refractive power (diopters) of the optical device. As shown, the fixed tab 504 and the spring tabs 510 and 512 can have an open cross-section. More specifically, and as better seen in the Figure 5D detailed view shown, the fixed tab 504 extends radially outward from the optical device 502 from a thinner inner portion 504B to an open thicker outer portion 504A. The hole 508 can extend through the thinner inner portion 504B. The outermost contour of the thicker portion 504A has a square profile with a front horizontal side, a rear horizontal side, and a lateral or outer vertical side, which, as previously described, are keyed to the recess 412 to minimize the front-to-back and radial / lateral movement of the lens 500 relative to the base 400. The thicker portion 504A also improves the engagement with the plunger of the injector, thereby reducing the jamming of the lens 500 in the injector. The thinner portion 504B also provides a forward and backward offset from the surface defining the recess 412 of the base 400, thereby reducing the adhesion between the lens 500 and the base 400. As shown, the same open configuration and associated advantages also apply to each of the spring tabs 510 and 512.

[0058] Commercially available IOLs typically have a mid-perimeter diameter of about 6 mm (excluding the haptics), a front-to-back thickness of about 0.2 mm at a 6 mm diameter, and a front-to-back thickness of about 0.7 mm at the center, thereby providing an overall volume of about 12 mm3. The lens 500 has similar dimensions, but the base 400 adds a much larger volume. The base 400 can have a mid-perimeter diameter of about 7.8 mm (excluding the haptics) and a front-to-back thickness of about 1 mm, thereby providing an overall volume of about 26 cubic millimeters when the lens is seated in the base [13.4 mm 3 base, 12.5 mm 3 optical device]. Thus, the combined dimensions of the base 400 and the lens 500 are much larger in volume than a conventional commercially available IOL. This relatively large volume is designed to fill the capsular bag more like a natural lens, thereby increasing the stability of the modular IOL 300 and reducing postoperative migration due to collapse of the capsular bag around the base 400. As a comparison, a typical natural lens has a mid-perimeter diameter of about 10.4 mm, a front-to-back dimension of about 4.0 mm, and a corresponding volume of about 180 mm3. Due to anatomical variations, the volume of the natural lens can range from 130 mm 3 to 250 mm 3 . Thus, after the natural lens is removed, the modular IOL 300 (base 400 plus lens 500) consumes greater than 10% (about 20% to 10.4%) of the capsular bag volume, while a conventional IOL consumes less than or equal to 10% (about 10% to 5%) of the capsular bag volume. In other words, the modular IOL 300 consumes about twice the capsular bag volume of a conventional IOL.

[0059] 58 Also in comparison to a conventional IOL, the modular IOL 300 provides a relatively large diameter and rigid platform by means of the annular ring 402 of the base 400, which resists deflection (i.e., increased stiffness in the sagittal plane, thereby improving front-to-back stability). Coupled with the relatively long sweeping haptics 406, which provide a significantly increased relative surface contact with the capsular bag, the modular IOL 300 provides excellent centration and stability within the capsular bag.

[0060] 59 The ability to resist deflection was demonstrated in a bench test comparing the performance of the modular IOL 300 to that of a commercially available IOL (Alcon model SA60), the results of which are shown in Figure 3B In the test setup, the test IOL was placed in a simulated capsular bag with a 10 mm inner diameter, and the assembly was submerged in a warm bath. While in a horizontal orientation, various loads were applied to the middle of the test IOL, and the resulting downward displacement was measured. From Figure 3BAs can be seen from the results shown, the commercially available IOL displacement is approximately five times that of the modular IOL 300, and the commercially available IOL fails to support a load of 0.058 grams because the haptics are displaced away from the simulated capsular bag. This indicates a significant relative increase in the stiffness of the modular IOL 300 compared to commonly commercially available IOLs.

[0061] 60 This test setup can be compared to a mechanical model of a central load on a beam with two simple supports described by F = k eq Δx, where F = the applied force, k eq = the equivalent stiffness, and Δx = the displacement. The equivalent stiffness takes into account the moment of inertia of the beam's cross-section and the material properties (Young's modulus of elasticity) of the beam. However, since the IOL is made of plastic (rather than an elastic material such as metal), the equivalent stiffness will vary within the range of the applied force. In the described bench tests, the modular IOL 300 has an equivalent stiffness of approximately 0.5 to 2.0 g / mm within the applied load range of 0.032 to 0.100 g, while the commercially available IOL has an equivalent stiffness of approximately 0.15 to 0.20 g / mm within the applied load range of 0.032 to 0.044 g.

[0062] 61 Generally, when the base 400 and the lens 500 are assembled together to form the modular IOL 300, these features can be configured such that the midplane of the optical device 502 is parallel to the midplane of the base 400, and the central (front - rear) axis of the optical device 502 coincides and is collinear with the central (front - rear) axis of the base 400. Assuming that the natural lens capsule has anatomical symmetry and the base 400 is centered within the lens capsule, this configuration essentially aligns the central axis of the optical device 502 with the central (front - rear) axis of the capsular bag, thereby centering the optical device 502. However, there may be cases where the visual (foveal) axis is not aligned with the anatomical (pupillary axis), and the difference is called the κ angle. In such cases, it may be necessary to offset the central axis of the optical device 500 relative to the base 400, thereby providing decentration. This can be achieved, for example, by configuring the tabs 504 and 506, the recesses 412, and / or the haptics 406 such that the central (front - rear) axis of the optical device 502 is laterally (towards the nose or temple) offset relative to the central (front - rear) axis of the base 400.

[0063] As an example and not a limitation, it is defined that the side walls of the recess 412 in the base 400 can be offset relative to the loop 406 such that the central axis of the optical device 502 is offset. Different offsets can be provided, for example, from 0.5 mm to 2.0 mm in increments of 0.5 mm. Angular orientation marks can be provided on the base 400 and the lens 500 to indicate the direction of the offset (towards the nose or temple). Similarly, the mid-plane of the assembled base 400 and the optical device 500 can be inclined relative to the mid-meridian plane of the natural capsular bag. To compensate for this inclination, for example, the tabs 504 and 506, the recess 412, and / or the loop 406 can be configured such that the mid-plane of the optical device 502 is reversely inclined.

[0064] The base 400 and the lens 500 including the alternative embodiments described herein can be formed by cryogenic processing and polishing of a hydrophobic acrylic material. Optionally, the base 400 can be manufactured by forming two (front and rear) components and bonding them together. For example, the two components can be hydrophilic acrylics that are cryogenically processed and joined together by a UV curable adhesive. Alternatively, the two components can be formed of different materials that are adhesively joined together. For example, the front component can be formed of a hydrophilic acrylic that does not adhere to the eye tissue, and the rear component can be formed of a hydrophobic acrylic that adheres to the eye tissue.

[0065] As another alternative, the base 400 can be manufactured by cryogenic processing a first component and overmolding a second component. The first component can include geometric features that become interlocked during overmolding, thereby reducing the need to use an adhesive to join these components. For example, the base 400 can be manufactured by cryogenically processing a hydrophilic acrylic to form the rear component and overmolding a front component of a plastic material such as silicone.

[0066] Although the hydrophobic acrylic makes the base 400 and the lens 500 visible in the case of using optical coherence tomography (OCT), it may be necessary to include materials that enhance OCT visualization. Exemplary "OCT-friendly" materials include, but are not limited to, polyvinyl chloride, glycol-modified poly(ethylene terephthalate) (PET-G), poly(methyl methacrylate) (PMMA), and polyphenylsulfone, such as polyphenylsulfone sold under the trade name RADELTM, as described in U.S. Patent Application Publication No. 2013 / 0296694 to Ehlers et al., which is incorporated herein by reference. Such OCT-friendly materials can be applied to or incorporated into a portion of the base 400 or the lens 500.

[0067] 66 As an example, concentric rings of OCT-friendly material can be applied to each of the lower edge 408 and the upper edge 410. These rings can have different diameters to assist in detecting the tilt of the base. Also as an example, OCT-friendly material can be applied to the tabs 504 / 506 of the lens 500. This can help determine whether the base 400 and the lens 500 are correctly assembled in the eye. Dots of OCT-friendly material can be applied to some portions of the base 400 that are aligned with corresponding dots of OCT-friendly material on the optic 500 to indicate correct assembly in the eye.

[0068] 67 As an alternative to solid materials, the base 400 and the lens 500 can be made of hollow materials that can then be inflated in the eye. In such an arrangement, the base 400 and the lens 500 can be made of, for example, molded silicone and inflated with a liquid such as saline, silicone gel, etc. using an injector and a needle. After implantation in the eye, the needle can pierce the walls of the base 400 and the lens 500 to inflate the components. After removal of the needle, the material can self-seal. As an alternative to hollow materials, the base 400 and the lens 500 can be formed of sponge-like materials such as silicone hydrogel that expands when hydrated. Both methods can allow for a smaller corneal incision size because the base 400 and the lens 500 are delivered in an un-inflated or un-expanded state and then inflate or expand once inside the eye.

[0069] 68 Generally, the modular IOL 300 including the assembled base 400 and lens 500 (including the alternative embodiments described herein) allows for adjustment or replacement of the lens 500 during or after surgery while leaving the base 400 in place. Examples of situations where this may be desirable include, but are not limited to: replacing the lens 500 to correct suboptimal refractive outcomes detected during surgery; replacing the lens 500 to correct less-than-ideal refractive outcomes (residual refractive error) detected postoperatively; rotationally adjusting the lens 500 relative to the base 400 to fine-tune toric correction; laterally adjusting the lens 500 relative to the base 400 to align the optic with the true optical axis (the true optical axis may not be the center of the capsular bag); and replacing the lens 500 to address different optical needs or expectations of the patient over a longer period of time. Examples of the latter situation include, but are not limited to: adult or pediatric IOL patients whose original optical correction needs to change as he / she grows; patients who wish to upgrade from a monofocal IOL to an advanced IOL (toric, multifocal, accommodative, or other future lens technologies); patients who are dissatisfied with an advanced IOL and want to downgrade to a monofocal IOL; and patients who develop a medical condition that is a contraindication for an IOL or a specific type of IOL.

[0070] 69 Referring to Figure 6A andFigure 6B , a perspective view and a cross-sectional view respectively illustrate an alternative modular IOL 330. The alternative modular IOL 330 may include an alternative base 600 and the lens 500 as described above. As will be understood from the following description, except for the front edge 610 and the rear edge 608, the alternative base 600 may be similar to the base 400, and the description of the similar aspects and advantages is incorporated herein by reference. The alternative base 600 includes an annular ring defining a central hole. A pair of haptics 606 extend radially outward from the annular ring. The annular ring includes a lower edge 608, an upper edge 610, and an inward-facing recess 612 into which the lens 500 may be inserted to form the modular IOL 330.

[0071] 70 Specifically refer to Figure 6B , the lower edge 608 and the upper edge 610 may have a relatively enlarged height and may be angled radially inward to form a funnel leading to the recess 612. With this arrangement, the actuatable tabs 506 of the lens may be compressed, and the lens 500 may be placed through the circular opening defined by the front edge 610, wherein the funnel shape of the front edge 610 guides the tabs 504 and 506 into the recess 612 of the base 600 to form a keyed geometry to restrict the movement of the lens 500 relative to the base 600 in the front, rear, and radial directions. The funnel shape of the rear edge 608 prevents the lens 500 from falling backward during the insertion of the lens 500 into the base 600.

[0072] 71 As an example, without necessarily being limiting, the base 600 may have the dimensions shown. As best seen in Figure 6B , the edges 608 and 610 of the base 400 may have a combined front-to-rear height that is 2.0 to 3.0 (or more) times the maximum thickness of the optical portion 502 of the lens 500. For example, the combined height of the edges 608 and 610 may be approximately 3 mm at a radial distance of approximately 2.9 mm from the center point. As previously described, the height of the rear edge 608 may be made greater than the height of the front edge 610 such that when the modular IOL 330 is implanted in the capsular bag, the sagittal midplane of the base 600 is aligned (+ / - 0.5 mm) with the mid-latitudinal plane of the lens 30. For example, the height ratio of the front edge 610 to the rear edge 608 may remain constant at a value less than 1.0, such as approximately 0.7 (± 0.3). As shown, the combined height of the front edge 610 and the rear edge 608 is selected such that when implanted in the capsular bag, the foremost portion of the front edge 610 is in close proximity (within 0.5 mm) to or abuts against the front side 33 of the lens 30, and the rearmost portion of the rear edge 608 is in close proximity (within 0.5 mm) to or abuts against the rear side 35 of the lens 30.

[0073] 72 Refer to Figure 7AAnd Figure 7B , a perspective view shows an alternative base 700 for use with a conventional IOL 100, where Figure 7A the separate base 700 is shown, and Figure 7B the combined base 700 and conventional IOL 100 assembled to form the modular IOL 360 are shown. Except for the inverted T-shaped slots 730, the alternative base 700 is similar to the previously described base 400, and the description of the similar aspects and advantages is incorporated herein by reference.

[0074] 73 The base 700 includes an annular ring 702 defining a central aperture 704. A pair of haptics 706 extend radially outward from the annular ring 702. The annular ring 702 includes a lower edge 708, an upper edge 710, and an inward-facing recess 712 into which the conventional IOL 100 can be inserted to form the modular IOL 360. The upper edge 710 of the annular ring 702 may include one or more notches 716 to provide access for a probe (e.g., a Sinskey hook) during surgery, which allows for easier manipulation of the base 700. For the same purpose as the notches 716, the haptics 706 may include apertures 715 adjacent to the annular ring 702.

[0075] 74 The annular ring 702 may include a pair of inverted T-shaped slots 730 to receive the haptics 106 that are radially opposite the conventional IOL 100. When the haptics 106 of the conventional IOL 100 are placed in the slots 730, the rear side of the optical portion 102 of the conventional IOL 100 may rest on the front surface of the rear edge 708. The rear portion of the slot 730 may have a greater width than its front portion to accommodate the angle of the haptics 106 and lock the IOL to the base when the IOL 100 rotates relative to the base 700. Adding the base 700 increases the front-to-back stiffness and height of the conventional IOL 100, thereby improving its stability.

[0076] 75 Referring to Figures 8A to 8C, perspective, cross-sectional, and top views of a non-modular IOL 800 are shown schematically. The non-modular IOL 800 incorporates several of the previously described stability advantages but employs a non-modular construction. For example, the IOL 800 includes an optical portion 802, which can be single focus (fixed focal length), accommodative (variable focal length), toric, multifocal, or extended depth of focus mode. The IOL 800 also includes two or more haptics 806 that extend radially outward from the periphery of the optical portion 802. Each haptic includes a posterior flange 808 and an anterior flange 810 that extend and flare radially inward from the outer edge 809 in the outward-backward and outward-forward directions, respectively. Each haptic 806 includes a connecting arm 812 that connects the outer edge 809 to the periphery of the optic 802. Each connecting arm 812 can include a window 814 to increase flexibility. The posterior flange 808 and the anterior flange 810 are configured to compress relative to each other in the anterior-posterior direction and thus act like a cantilever leaf spring about the outer edge 809.

[0077] 76 Specifically refer to Figure 8B , which is a cross-sectional view taken along line B-B in Figure 8A . It can be understood that the posterior flange 808 is sized and configured to be different from the anterior flange 810 to conform to the shape of the capsular bag. As previously mentioned, the posterior thickness of the native lens is greater than the anterior thickness of the native lens. To enable the anterior flange 810 to conform to the anterior side 33 of the lens capsule and the posterior flange 808 to conform to the posterior side 35 of the lens capsule, the anterior flange 810 can have an anterior height H A and arc length that are less than the posterior height H P and arc length of the posterior flange 808. For example, H P can be made greater than H A such that when the IOL 800 is implanted in the capsular bag, the sagittal midplane MP of the base 800 is aligned (+ / - 0.5 mm) with the mid-latitudinal plane of the lens capsule. For example, the ratio H A / H P can be constant at approximately 0.7 (± 0.3).

[0078] 77 Specifically refer to Figure 8B and Figure 8C, the radial lengths (in the sagittal plane) of the posterior flange 808 and the anterior flange 810 can be selected such that the innermost edges do not interfere with the field of view through the optical device 802. In other words, the posterior flange 808 and the anterior flange 810 can extend radially inward from the outer edge 809 until the outer diameter of the optical portion 802, where the inner edges of the posterior flange 808 and the anterior flange 810 form an arc that conforms to the outer diameter of the optical device 802. The outer edge 809 can also form an arc, where the haptics 806 conform to the circular shape of the mid-meridian of the natural lens capsule. By way of example, but not necessarily by way of limitation, the arc shape of the haptics 806 can extend around the circumference of the optical device 802 by 60° to 90°, 90° to 120°, or 120° to 150°. The greater the arc length of the haptics, the greater the contact area with the mid-meridian of the natural lens capsule and the greater the stability of the IOL 800 in the capsular bag, but this must be balanced with the use of an injector to deliver the IOL 800 through a small incision.

[0079] 78 Reference Figure 9A and Figure 9B , perspective views are shown of alternative non-modular IOLs 900 and 950, respectively. The IOLs 900 and 950 are similar to the above-described IOL 800 in that the haptics include deployed flanges to improve stability; descriptions of similar aspects and advantages are incorporated herein by reference.

[0080] 79 For example, with specific reference to Figure 9A, the IOL 900 includes an optical portion 902, which can be single - focus (fixed focal length), accommodative (variable focal length), toric, multifocal, or extended depth of focus mode. The IOL 900 also includes two or more haptics 906 that radially extend outwardly from the periphery of the optical portion 902. Each haptic 906 includes a posterior flange 908 and an anterior flange 910 that radially inwardly extend and flare from the outer edge 909 in the outward - backward and outward - forward directions, respectively. Each haptic 906 includes a pair of connecting arms 912 that connect the outer edge 909 to the periphery of the optic 902. Each pair of connecting arms 912 can include a window 914 to increase flexibility. The posterior flange 908 and the anterior flange 910 are configured to compress relative to each other in the anterior - posterior direction, thus acting like a cantilever leaf spring about the outer edge 909. Compared with the IOL 800, the flanges 908 and 910 of the IOL 900 have a smaller radial length (in the sagittal plane) extending from the outer edge 909 toward the optic 902. Additionally, a gap 911 is provided along the inner connection of the connecting arms 912 with the flanges 908 and 910 to the outer edge 909 to provide space for the flanges 908 and 910 to compress and fold downwardly toward the optic 902. The gap 911 allows the connection between the outer edge 909 and the flanges 908 and 910 to act as an elastic hinge and allows the flanges 908 and 910 to better conform to the interior of the capsular wall, which can vary in size and dimensions.

[0081] 80 Reference Figure 9B , the IOL 950 is similar to the IOL 900, and descriptions of similar aspects and advantages are incorporated herein by reference. The IOL 950 includes one or more haptics 906, which include curved arms 916 (instead of connecting arms 912) extending from the periphery of the optic 902 to form the outer edge 909 from which the flanges 908 and 910 extend. As in the previous embodiments, a gap 911 is provided to enhance the flexibility of the flanges 908 and 910 relative to the curved arms 916 along the outer edge 909 such that the connection between them acts as an elastic hinge.

[0082] 81 Reference Figure 10A and Figure 10B , an alternative non - modular IOL 1000 is schematically shown. Figure 10A is a top view of the IOL1000, and Figure 10B is along Figure 10ACross-sectional view taken along line B-B in. For example, IOL 1000 includes an optical portion 1002, which may be single focus (fixed focal length), adaptive (variable focal length), toric, multifocal, or extended depth of focus mode. IOL 1000 also includes a pair of haptics 1006 extending outward from the optical portion 1002. A pair of gussets 1004 connect the haptics 1006 to the optical portion 1002. Given that conventional IOLs provide haptics extending from the optical portion, IOL 1000 uses gussets 1004 to radially push the attachment location of the haptics 1006 outward, thereby relatively increasing the anterior-posterior stiffness in the sagittal plane of the IOL. IOL 1000 also includes a rearward extending ridge 1008 around the perimeter of the optic 1002 and the perimeter of the gussets 1004, excluding the haptics 1006 and the junctions of the haptics 1006 with the gussets 1004. The ridge 1008 increases the sectional moment of inertia in the sagittal plane of IOL 1000, thereby increasing its stiffness and stability without affecting the flexibility of the haptics 1006. As seen in cross-section, the ridge 1008 may have an internal rounded corner and an external square edge, as shown, to inhibit cell proliferation on the optical portion 1002. By way of example, but not necessarily by limitation, the haptics may have an outer extent of 13 mm (haptic tip to haptic tip), the optic may have a diameter of 5 mm to 6 mm, and the gussets 1004 may have an average sagittal width of 1 mm to 2 mm. Thus, for an optic 1002 with a diameter of 5.0 mm, the haptics 1006 may be attached to the gussets 1004 at a diameter of 7.0 mm to 9.0 mm.

[0083] 82 Reference Figure 11A and Figure 11B , schematically shows another alternative non-modular IOL 1100. Figure 11A is a top view of IOL 1100, and Figure 11B is along Figure 11APerspective cross-sectional view taken along line B-B in []. As will be understood from the following description, except with respect to ridge 1108, IOL 1100 may be similar to IOL 1000, and descriptions of similar aspects and advantages are incorporated herein by reference. For example, IOL 1100 includes an optical portion 1102, which may be a single focus (fixed focal length), accommodative (variable focal length), toric, multifocal, or extended depth of focus mode. IOL 1102 also includes a pair of haptics 1106 extending outwardly from the optical portion 1102. A pair of gussets 1104 connect the haptics 1006 to the optical portion 1102. Given that conventional IOLs provide haptics extending from the optical portion, IOL 1100 uses gussets 1104 to radially outwardly push the attachment location of the haptics 1106, thereby relatively increasing the anterior-posterior stiffness of the IOL in the sagittal plane. IOL 1100 also includes a ridge 1108 that extends around the perimeter of the optic 1102 and extends in the forward and backward directions. Ridge 1108 increases the moment of inertia of the cross-section of IOL 1100 in the sagittal plane, thereby increasing its stiffness and stability without affecting the flexibility of gussets 1104 or haptics 1106. As seen in cross-section, ridge 1108 may be rounded in an oval shape.

[0084] 83 Reference Figure 12A and Figure 12B , schematically shows yet another alternative non-modular IOL 1200. Figure 12A is a top view of IOL 1200, and Figure 12B is a cross-sectional view taken along Figure 12A line B-B in []. As will be understood from the following description, except with respect to gussets or support portion 1204 and one or more ridges 1208, IOL1200 may be similar to IOL1000, and descriptions of similar aspects and advantages are incorporated herein by reference.

[0085] 84 For example, IOL 1200 includes an optical portion 1202, which may be a single focus (fixed focal length), accommodative (variable focal length), toric, multifocal, or extended depth of focus mode. IOL 1200 also includes a pair of haptics 1206 extending outwardly from the optical portion 1202. Support portion 1204 extends around the perimeter of the optical portion 1220 and connects the haptics 1206 to the optical portion 1202. Given that conventional IOLs provide haptics extending from the optical portion, IOL 1200 uses support portion 1204 to radially outwardly push the attachment location of the haptics 1206, thereby relatively increasing the anterior-posterior stiffness of the IOL 1200 in the sagittal plane.

[0086] 85 The support portion 1204 can surround the optical device 1202. For example, the support portion 1204 can extend concentrically around the radial outer perimeter of the optical device 1202 for a full 360°. In one example, the support portion 1204 can include an annular plate that forms a band around the optical device 1202. The plate can have a substantially constant width between its inner and outer circumferences.

[0087] 86 The support portion 1204 can include a front-facing surface 1204a and a rear-facing surface 1204b. At least one of the front-facing surface 1204a and the rear-facing surface 1204b of the support portion 1204 can extend substantially perpendicular to the optical axis 1202a of the optical device 1202. The optical device 1202 can have a curved front-facing surface 1202b and / or a curved rear-facing surface 1202c. An annular recessed region 1203 can be formed on the front side and / or the rear side of the IOL 1200 where the support portion 1204 meets the optical device 1202, because an angle is formed between the front-facing surface 1204a of the support portion 1204 and the front-facing surface 1202b of the optical device 1202, and / or an angle is formed between the rear-facing surface 1204b of the support portion 1204 and the rear-facing surface 1202c of the optical device 1202.

[0088] 87 The thickness of the support portion 1204 measured between the front-facing surface 1204a and the rear-facing surface 1204b of the support portion 1204 can be substantially equal to the thickness of the radial outer perimeter of the optical device 1202 (measured between the perimeters of the front-facing surface 1202b and the rear-facing surface 1202c of the optical device 1202). Additionally or alternatively, the thickness of the support portion 1204 can be substantially equal to the thickness of the haptic 1206 (measured between the front-facing surface 1206a and the rear-facing surface 1206b of the haptic 1206).

[0089] The 88 IOL 1200 may also include one or more protrusions or ridges 1208. One or more ridges 1208 may extend around, along, and / or around one or more portions of the radially outer perimeter of the support portion 1204 and the haptics 1206. In one example, one or more ridges 1208 may include one or more ridges that extend from the forward-facing surface 1204a of the support portion 1204 in the forward direction. For example, one or more forward-extending ridges may include ridge 1208a and / or ridge 1208b. Additionally or alternatively, one or more ridges 1208 may include one or more ridges that extend from the rearward-facing surface 1204a of the support portion 1204b in the rearward direction. For example, one or more rearward-extending ridges may include ridge 1208c and / or ridge 1208d. One or more ridges 1208 may increase the cross-sectional moment of inertia of the entire IOL 1200 in the sagittal plane, including the optics 1202, the support portion 1204, and the haptics 1206, thereby increasing its stiffness and stability. Although Figure 12A and Figure 12B a pair of forward-extending ridges 1208a and 1208b and a pair of rearward-extending ridges 1208c and 1208d are shown, it is contemplated that fewer ridges may be employed. For example, the IOL 1200 may include only the forward-extending ridges 1208a and 1208b, or only the rearward-extending ridges 1208c and 1208d.

[0090] 89 As seen in the cross-section in Figure 12B one or more ridges 1208 may have a square profile to reduce cell proliferation on the optical portion 1202. For example, one or more of ridges 1208a, 1208b, 1208c, and 1208d may include opposing surfaces 1208e and 1208f that extend substantially perpendicular to the forward-facing surface 1204a and / or the rearward-facing surface 1204b of the support portion 1204. Additionally or alternatively, the opposing surfaces 1208e and 1208f may extend substantially parallel to each other. Additionally or alternatively, one or more of ridges 1208a, 1208b, 1208c, and 1208d may include end surfaces 1208g that extend substantially parallel to the forward-facing surface 1204a and / or the rearward-facing surface 1204b of the support portion 1204. Surface 1208f may be flush with the radially outer circumferential surface of the support portion 1204 and / or the haptics 1206.

[0091] The 90 ridge 1208a can bend over, along, or around the outside of one of the loops 1206 and can taper (e.g., can taper downward in height) at or near the tip of the loop 1206. The tapered portion can define the first end of the ridge 1208a. The ridge 1208a can have a second end opposite its first end. The second end can taper (e.g., can taper downward in height). The taper at the second end of the ridge 1208a can have a greater slope than the taper at the first end. The ridges 1208b, 1208c, and 1208d can be shaped similarly.

[0092] 91 Between their tapered ends, the ridges 1208a, 1208b, 1208c, and 1208d can have a height (measured in the front - rear direction relative to the surface of the support portion 1204) such that the front - facing surface 1202b of the optical device 1202 can extend in front of the ridge 1208a and / or the ridge 1208b, and / or the rear - facing surface 1202c of the optical device 1202 can extend behind the ridge 1208c and / or the ridge 1208d. It is also contemplated that one or more of the ridges 1208a, 1208b, 1208c, 1208d can have a constant height between their tapered ends.

[0093] 92 As Figure 12A best shown, the ridges 1208a and 1208b can be discrete ridges separated by a gap. Additionally or alternatively, the ridges 1208c and 1208d can be discrete ridges separated by a gap. For example, the inner bend of the loop 1206 can exclude the ridge to allow the loop 1206 to radially compress towards the optical portion 1202.

[0094] 93 The ridge 1208a can include a first curved portion 1208h and a second curved portion 1208i. From the perspective of the optical device 1202, the first curved portion 1208h and the second curved portion 1208i can be substantially concave. Where the first curved portion 1208h and the second curved portion 1208i meet, they can form a raised portion 1208j of the ridge 1208a. The ridges 1208b, 1208c, and / or 1208d can be shaped similarly.

[0095] 94 One or more of the ridges 1208 can be arranged in pairs. For example, the ridges 1208a, 1208b can form a first pair of front ridges, and / or the ridges 1208c, 1208d can form a second pair of rear ridges. Regarding the pair of ridges 1208a and 1208b, the end portion of one ridge can extend beyond the opposite end portion of the other ridge and towards the middle portion of the other ridge. A similar arrangement can exist for a pair of ridges 1208c and 1208d.

[0096] 95 References Figures 13A to 13C ,shows in perspective various alternative non-modular IOLs 1300A, 1300B, and 1300C. For example, each IOL 1300 includes an optical portion 1302, which can be single focus (fixed focal length), adaptive (variable focal length), toric, multifocal, or extended depth of focus mode. Each IOL 1300 also includes two or more haptics 1306 connected to the optical portion 1302 via connecting arms 1312. Compared with conventional IOLs, where the haptics are curved to provide a radial spring force in addition to contacting the inner equator of the lens capsule, the connecting arms 1312 provide a radial spring force independent of the haptics 1306, and the haptics 1306 can be circular to maintain the same amount of contact area with the inner equator of the lens capsule independent of the radial compression of the connecting arms 1312. This configuration provides more consistent stability for the IOL 1300 in the lens capsule regardless of the size of the capsular bag. For example, the haptics 1306 can extend around the perimeter of the optic 1302 from 60° to 90°, 90° to 120°, or 120° to 150°, and can have a constant radius of about 4.0 to 5.0 mm. For example, the connecting arms 1312 can be in the form of a multi-bar cantilever (Z-shaped) spring 1312A, a single-bar cantilever (curved) spring 1312B, or a semi-elliptical spring 1312C.

[0097] 96 The foregoing discussion of the present disclosure has been presented for purposes of illustration and description. The foregoing is not intended to limit the present disclosure to one or more forms disclosed herein. Although the present disclosure includes a description of one or more embodiments and certain variations and modifications, other variations and modifications, such as within the skill and knowledge of those in the art after understanding the present disclosure, are within the scope of the present disclosure. It is intended to obtain rights to include alternative embodiments to the extent permitted, which alternative embodiments include alternative, interchangeable, and / or equivalent structures, functions, scopes, or steps of those claimed, whether or not such alternative, interchangeable, and / or equivalent structures, functions, scopes, or steps are disclosed herein, and no patentable subject matter is intended to be dedicated.

Claims

1. An intraocular lens system, comprising: a. A base, the base comprising: an annular body having a central hole extending therethrough, the annular body comprising: a rear protrusion extending around the inner circumference of the annular body, two slots extending from the front side of the annular body to the rear protrusion, and two loops extending radially outward from the annular body; and b. A lens, the lens comprising an optical portion and two loops extending radially outward from the optical portion, wherein the lens is disposed in the central hole of the annular body and rests on the front side of the rear protrusion, and wherein the loops of the lens are disposed in the slots and extend radially outward from the annular body.

2. The intraocular lens system according to claim 1, wherein, The two loops of the lens extend from diametrically opposite sides of the optical portion.

3. The intraocular lens system according to claim 1, wherein, Each of the slots has a rear portion and a front portion.

4. The intraocular lens system according to claim 3, wherein, The width of the rear portion is greater than the width of the front portion.

5. The intraocular lens system according to claim 1, wherein, Each of the slots is in an inverted T shape.

6. The intraocular lens system according to claim 1, wherein, Each loop of the lens includes an inclined portion connecting itself to the optical portion.

7. The intraocular lens system according to claim 6, wherein, Each of the slots includes an inclined portion configured to receive the loop of the lens.

8. The intraocular lens system according to claim 1, wherein, Each of the slots is configured to interlock with the loop of the lens when the lens is rotated relative to the base.

Images