Intraocular lens design for improved stability

By enhancing the stiffness and contact area of intraocular lenses through modular and non-modular designs, the stability of IOLs within the lens capsule is improved, addressing issues of refractive power surprises and lens position stability.

JP7654747B2Active Publication Date: 2025-04-01CLARVISTA MEDICAL INC +1
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Patent Information

Application Number
JP2023182704
Authority / Receiving Office
JP · JP
Patent Type
Patents
Current Assignee / Owner
Priority Date
2017-05-03
Filing Date
2023-10-24
Publication Date
2025-04-01
Estimated Expiration
2037-05-04

AI Technical Summary

Technical Problem

Existing intraocular lenses (IOLs) often experience movement within the lens capsule after surgery, leading to refractive power surprises and ineffective lens position stability, which can significantly impact vision.

Method used

The development of modular and non-modular IOL designs that enhance anteroposterior stiffness, increase contact area with the lens capsule, and incorporate features such as expanded annular edges and adjustable components to improve stability and reduce movement.

Benefits of technology

These designs significantly improve the stability of the IOL within the lens capsule, reducing refractive power surprises and maintaining optimal lens position, thereby enhancing visual outcomes.

✦ Generated by Eureka AI based on patent content.

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Patent Text Reader

Abstract

To provide intraocular lenses (IOLs) that improve lens stability by, for example, increasing anterior-posterior stiffness of the IOL, increasing anterior-posterior dimensions of the IOL and / or increasing the contact area with the equator of the capsular bag to prevent movement of the IOL as the capsular bag collapses over time.SOLUTION: An intraocular lens comprises: an optic portion defining an optical axis extending in an anterior-posterior direction; a support portion extending radially outward from a periphery of the optic portion; a hold extending radially outward from the support portion; and a ridge extending in an anterior-posterior direction from a periphery of the support portion.SELECTED DRAWING: Figure 3A
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Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of priority under 35 U.S.C. §119(e) to U.S. Provisional Patent Application No. 62 / 332,163, entitled "INTRAOCULAR LENS DESIGNS FOR IMPROVED STABILITY," filed May 5, 2016, which is incorporated herein by reference in its entirety.

[0002] This application is related to U.S. patent application Ser. No. 15 / 342,806, filed Nov. 3, 2016, entitled "MODULAR INTRAOCULAR LENS DESIGNS, TOOLS AND METHODS," U.S. patent application Ser. No. 15 / 218,658, filed July 25, 2016, entitled "MODULAR INTRAOCULAR LENS DESIGNS, TOOLS AND METHODS," U.S. patent application Ser. No. 15 / 176,582, filed June 8, 2016, entitled "MODULAR INTRAOCULAR LENS DESIGNS AND METHODS," U.S. patent application Ser. No. 15 / 176,582, filed May 9, 2016, entitled "MODULAR INTRAOCULAR LENS DESIGNS, TOOLS AND METHODS," U.S. patent application Ser. No. 15 / 150,360, now U.S. Patent No. 9,421,088, entitled "INTRAOCULAR LENS DESIGNS FOR IMPROVED STABILITY," filed May 5, 2016; U.S. Provisional Patent Application No. 62 / 332,163, filed April 5, 2016, entitled "MODULAR INTRAOCULAR LENS DESIGNS, TOOLS AND METHODS," filed February 26, 2016; U.S. Provisional Patent Application No. 62 / 318,272, filed February 26, 2016, entitled "MODULAR INTRAOCULAR LENS DESIGNS, TOOLS AND METHODS," filed February 26, 2016; No. 15 / 054,915, filed Nov. 17, 2015, entitled “MODULAR INTRAOCULAR LENS DESIGNS AND METHODS”; U.S. Provisional Patent Application No. 62 / 256, filed Nov. 17, 2015, entitled “MODULAR INTRAOCULAR LENS DESIGNS AND METHODS”;No. 579, U.S. Provisional Patent Application No. 62 / 250,780, filed November 4, 2015, entitled “MODULAR INTRAOCULAR LENS DESIGNS, TOOLS AND METHODS,” U.S. Provisional Patent Application No. 14 / 828,083, now U.S. Patent No. 9,364,316, filed August 17, 2015, entitled “MODULAR INTRAOCULAR LENS DESIGNS, TOOLS AND METHODS,” U.S. Provisional Patent Application No. 14 / 828,083, now U.S. Patent No. 9,364,316, filed July 24 ... No. 14 / 808,022, now U.S. Patent No. 9,387,069, entitled “MODULAR INTRAOCULAR LENS DESIGNS, TOOLS AND METHODS,” filed January 30, 2015; U.S. Provisional Patent Application No. 62 / 110,241, filed January 30, 2015, entitled “MODULAR INTRAOCULAR LENS DESIGNS, TOOLS AND METHODS,” filed January 30, 2015; U.S. Patent Application No. 14 / 610,360, filed February 18, 2014, entitled “MODULAR INTRAOCULAR LENS DESIGNS, TOOLS AND METHODS,” filed February 18, 2014; No. 61 / 941,167, filed Aug. 16, 2013, entitled “MODULAR INTRAOCULAR LENS DESIGNS & METHODS,” now U.S. Patent Application No. 13 / 969,115, filed July 9, 2013, entitled “MODULAR INTRAOCULAR LENS DESIGNS AND METHODS,” now U.S. Patent No. 9,289,287, filed Jul. 9, 2013, entitled “MODULAR INTRAOCULAR LENS DESIGNS AND METHODS,” now U.S. Patent No. 9,125,No. 13 / 937,761, now U.S. Patent No. 9,095,424, entitled "MODULAR INTRAOCULAR LENS DESIGNS & METHODS," filed on June 3, 2013; U.S. Provisional Patent Application No. 61 / 830,491, now U.S. Patent No. 9,095,424 ... No. 61 / 589,981, entitled "MODULAR INTRAOCULAR LENS DESIGNS & METHODS," filed on July 30, 2012, each of which is hereby incorporated by reference in its entirety.

[0003] The present disclosure relates generally to intraocular lenses (IOLs). More particularly, the present disclosure relates to embodiments of IOL designs for improved stability within the capsular bag. [Background technology]

[0004] The human eye functions to provide vision by transmitting light through a clear outer portion called the cornea and focusing the image onto the retina by the lens. The quality of the focused image depends on a number of factors, including the size and shape of the eyeball and the transparency of the cornea and lens.

[0005] When the lens becomes less transparent (e.g., clouded) due to aging or disease, vision is impaired because less light can pass through to the retina. This abnormality of the eye's lens is medically known as a cataract. The accepted treatment for this condition is to surgically remove the lens from the capsule and place an artificial intraocular lens (IOL) in the capsule. In the United States, most cataractous lenses are removed using a surgical procedure called phacoemulsification. During this procedure, an incision (capsulorhexis) is made in the anterior lens capsule and a thin phacoemulsification tip is inserted into the diseased lens and vibrated with ultrasound. The vibrating tip liquefies or emulsifies the lens, preparing it for aspirating out of the capsule. Once the diseased lens is removed, it is replaced with an IOL.

[0006] After cataract surgery for IOL implantation, the optical outcome may not be optimal. For example, it may be determined shortly after surgery that the refractive power is not correctly corrected, causing a refractive error sometimes called "power surprise". This may be due in part to IOL movement within the capsular bag after surgery. Effective lens position (ELP), often measured using Scheimpflug photography (e.g., Pentacam, Oculus, Germany), is a measure of the anterior-posterior distance from the anterior surface of the cornea to the anterior surface of the lens (known as the anterior chamber depth or ACD). ELP can change significantly after surgery, with a 1.0 mm deviation in ELP corresponding to a 3.0 diopter change in visual acuity. Thus, there is a need for an IOL that is more stable after surgery, reduces ELP changes, and reduces power surprise. Summary of the Invention [Means for solving the problem]

[0007] Embodiments of the present disclosure provide IOLs that improve ELP stability, for example, by increasing the anterior-posterior stiffness of the IOL, increasing the anterior-posterior dimension of the IOL, and / or increasing the contact area with the equator of the capsular bag to reduce movement of the IOL as the capsule collapses over time. These IOLs may be non-modular, one-piece or monolithic (i.e., single piece), or modular (multiple pieces). In modular embodiments, the IOL system may include an intraocular base and an optic that, when combined, form a modular IOL.

[0008] In one embodiment, the modular IOL includes an annular base having two haptics extending radially outward. The base may define a central hole and an inner circumferential surface and may have a recess along the inner circumferential surface that opens radially inward. The modular IOL system also includes a lens having an optic body with first and second tabs extending radially outward from the optic body. The base and lens may be assembled with the first and second tabs of the lens in the recesses of the base. The base may have an anteroposterior dimension larger than the lens to increase anterior-posterior stiffness of the assembly. The base may also have an anteroposterior dimension that is closer to the anteroposterior dimension within the capsule (i.e., between the leaflets of the capsule) to reduce anterior-posterior slippage within the capsule.

[0009] In another embodiment, the modular IOL includes a base configured to receive a conventional lens. The base may be an annulus having a central hole, two radially outwardly extending haptics, and an inner protrusion for receiving the conventional lens with the haptics. The base and lens may be assembled with the periphery of the lens resting on the protrusions of the base and the haptics of the lens extending into the slots of the base. As with other embodiments described herein, the base may have a larger anterior-posterior dimension than the lens to increase the anterior-posterior stiffness of the assembly. In addition, the base may also have an anterior-posterior dimension that is closer to the anterior-posterior dimension in the capsule (i.e., between the cusps of the capsule) to reduce anterior-posterior slippage within the capsule.

[0010] In yet another embodiment, the non-modular IOL includes an extended annular rim around the optic to increase anterior-posterior stiffness. The extended annular rim may have an anterior-posterior dimension that approximates the anterior-posterior dimension within the capsular bag (i.e., between the cusps of the capsular bag). A gap may be provided within the rim to allow folding for delivery by the injector. The rim may extend radially outward to form a protrusion between the optic and the haptics extending from the optic.

[0011] IOLs according to embodiments of the present disclosure may be applied to various types of IOLs, including fixed monofocal, multifocal, toric, accommodative, and combinations thereof. In addition, IOLs according to embodiments of the present disclosure may be used to treat severe refractive errors in eyes, such as cataracts, myopic (near-sighted), hyperopic (far-sighted), astigmatic, cataractous cataracts, aphakia, pseudophakia, and nuclear sclerosis.

[0012] Various other aspects and advantages of the embodiments of the present disclosure are set forth in the following detailed description and drawings. The drawings illustrate exemplary embodiments of the present disclosure. The drawings are not necessarily to scale, may include similar elements numbered the same, and dimensions (in millimeters) and angles (in degrees) may be included by way of example and not necessarily by way of limitation. In the drawings: [Brief description of the drawings]

[0013] [Figure 1] FIG. 1 is a schematic diagram of the human eye shown in cross-section. [Diagram 2] FIG. 1 is a schematic diagram of the human eye lens shown in sagittal section. [Figure 3A] 1 is a perspective view of a modular IOL according to the present disclosure. [Figure 3B] 3B is a graph of the results of bench testing comparing the performance of the modular IOL shown in FIG. 3A with the performance of a commercially available IOL. [Figure 4A]3B are a perspective view, a top view, a cross-sectional view, and a detailed view, respectively, of the base of the modular IOL shown in FIG. 3A. [Figure 4B] Same as above. [Figure 4C] Same as above. [Figure 4D] Same as above. [Figure 5A] 3B are a perspective view, a top view, a cross-sectional view, and a detailed view, respectively, of the lens of the modular IOL shown in FIG. 3A. [Figure 5B] Same as above. [Figure 5C] Same as above. [Figure 5D] Same as above. [Figure 5E] Same as above. [Figure 6A] 1A and 1B are perspective and cross-sectional views, respectively, of an alternative modular IOL according to the present disclosure. [Figure 6B] Same as above. [Figure 7A] FIG. 1 is a perspective view of an alternative base for use with a conventional IOL in accordance with the present disclosure. [Figure 7B] Same as above. [Figure 8A] 1A-1D are perspective, cross-sectional, and top views, respectively, of a non-modular IOL according to the present disclosure. [Figure 8B] Same as above. [Figure 8C] Same as above. [Figure 9A] FIG. 1 is a perspective view of an alternative non-modular IOL according to the present disclosure. [Figure 9B] Same as above. [Figure 10A] 1A and 1B are top and cross-sectional views, respectively, of another alternative non-modular IOL according to the present disclosure. [Figure 10B] Same as above. [Figure 11A] 1A and 1B are top and cross-sectional views, respectively, of yet another alternative non-modular IOL according to the present disclosure. [Figure 11B] Same as above. [Figure 12A] 1A and 1B are top and cross-sectional views, respectively, of a further alternative non-modular IOL according to the present disclosure. [Figure 12B] Same as above. [Figure 13A] 1A-1D are perspective views of various alternative non-modular IOLs according to the present disclosure. [Figure 13B] Same as above. [Figure 13C] Same as above. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0014] Reference will now be made in detail to examples of the present disclosure, which are illustrated in the accompanying drawings. Wherever possible, the same reference numbers are used throughout the drawings to refer to the same or similar parts. In the following description, relative terms such as "about," "substantially," and "approximately" are used to indicate a possible variation of ±10% of a stated value, numerical value, or other value, unless other variations are specifically indicated.

[0015] Referring to FIG. 1, a human eye 10 is shown in cross section. The eye 10 has been described as a light-responsive organ for several purposes. As a sensory organ with perceptual responses, the eye provides vision. The rod and cone cells of the retina 24 provide light perception and vision with perceptual responses including color differences and depth perception. In addition, non-imaging light-sensitive ganglion cells within the retina 24 of the human eye receive light signals that affect the regulation of pupil size, the regulation and inhibition of the hormone melatonin, and the entrainment of the body clock.

[0016] The eye 10 is not exactly a sphere, but rather a fusion of two parts. The smaller, anterior part is more curved and is called the cornea 12, and is connected to the larger part called the sclera 14. The cornea 12 typically has a radius of about 8 mm (0.3 inches). The sclera 14 makes up the remaining 5 / 6ths and typically has a radius of about 12 mm. The cornea 12 and sclera 14 are connected by a ring called the limbus. The cornea 12 is transparent, so instead of the cornea 12, the iris 16, which is the color of the eye, and its black center, the pupil, are seen. To see inside the eye 10, an ophthalmoscope is needed, as light is not reflected outwards. The fundus (the area opposite the pupil), which contains the macula 28, shows the characteristic pale optic disc (optic nerve head), the location where the blood vessels entering the eye pass and where the optic nerve fibers exit the eye.

[0017] Thus, the eye 10 is composed of three membranes, which surround three transparent structures. The outermost layer is composed of the cornea 12 and the sclera 14. The middle layer is composed of the choroid 20, the ciliary body 22, and the iris 16. The innermost layer is the retina 24, which gets its circulation from the blood vessels of the choroid 20 and the retinal blood vessels, which can be seen under an ophthalmoscope. Among these membranes are the aqueous humor, the vitreous body 26, and the flexible crystalline lens 30. The aqueous humor is a transparent fluid contained in two regions: the anterior chamber between the cornea 12 and the exposed area of ​​the iris 16 and the crystalline lens 30, and the posterior chamber between the iris 16 and the crystalline lens 30. The crystalline lens 30 is suspended from the ciliary body 22 by the ciliary ridge ligament 32 (zonules of Zinn), which are composed of fine transparent fibers. The vitreous body 26 is a transparent jelly that is much larger than the aqueous humor.

[0018] The crystalline lens 30 is a transparent, biconvex structure within the eye which, together with the cornea 12, helps refract light so that it is focused on the retina 24. By changing its shape, the crystalline lens 30 functions to change the focal length of the eye, allowing it to focus on objects at various distances, so that a sharp, real image of the object of interest is formed on the retina 24. This adjustment of the crystalline lens 30 is known as accommodation, and is similar to the way a photographic camera focuses by moving its lens.

[0019] The lens has three main parts: the lens capsule, the lens epithelial cells, and the lens fiber cells. The lens capsule forms the outermost layer of the lens, and the lens fiber cells form most of the interior of the lens. The lens epithelial cells are located between the lens capsule and the outermost layer of lens fiber cells, primarily on the anterior side of the lens, but also extend posteriorly a little beyond the lens equator.

[0020] The lens capsule is a smooth, transparent basement membrane that completely surrounds the lens. It is elastic and composed of collagen. It is synthesized by the lens epithelial cells and its main components are type IV collagen and sulfated glycosaminoglycans (GAGs). The lens capsule is elastic, which allows the lens to become more spherical when the zonular fibers that connect it to the ciliary body 22 are not under tension. The thickness of the lens capsule varies from about 2 to 28 micrometers from its thickest point near the equator of the lens to its thinnest point near the posterior pole of the fundus. The lens capsule may be associated with a greater anterior curvature than the posterior portion of the lens.

[0021] Various pathologies and disorders of the lens 30 may be treated with IOLs. For example, but not necessarily by way of limitation, IOLs according to embodiments of the present disclosure may be used to treat cataracts, myopic (near-sighted), hyperopic (far-sighted), and severe refractive errors in astigmatic eyes, cataracts, aphakia, pseudophakia, and nuclear sclerosis. For purposes of illustration, however, embodiments of the IOLs of the present disclosure will be described with reference to cataracts, which often occur in elderly people.

[0022] 2, the shape of the lens 30 is approximately symmetrical about the visual axis 37. However, the lens 30 is not symmetrical about the sagittal plane 39. Rather, the anterior surface 33 of the lens 30 has a radius of curvature (R P ) with a radius of curvature (R A ) The equatorial diameter (D) is more anterior and the posterior lens thickness (T P ) is the anterior lens thickness (T A ) is greater than

[0023] Rosen et al. (2006) reported that the equatorial diameter D and posterior lens thickness T P , anterior lens thickness T A , and the front radius of curvature R A changes with age, while the posterior curvature radius R P and T A and T P published data suggesting that the ratio of circulatory function to age-related circulatory function remains constant. Using best-fit linear equations, Rosen et al. described the following age-dependent equations for these parameters (all in mm): D = 0.0138 (± 0.002) * age + 8.7 (± 0.14) (R 2 =0.57; p<0.0001), T A =0.0049(±0.001)*age+1.65(±0.075)(R 2 =0.45;p<0.0001), T P =0.0074(±0.002)*age+2.33(±0.11)(R 2 =0.44;p<0.0001), R A =0.046(±0.017)*age+7.5(±1.13)(R 2 =0.27; p=0.016), R P =-5.5 (±0.9), and T A / T P =0.70(±0.13).

[0024] These data or other experimentally measured data may be used to indicate the shape and size of the lens for a particular age group, such as, but not limited to, cataracts in elderly patients with an average age of 70 years. Such data may be useful in determining the space available for placement within the lens capsule. For example, assume that an ocular implant (such as an IOL) is centered at the equatorial plane, with an anterior-posterior height "H" at a radial distance "X" from that center point. Also assume that it is desired to have the anterior and posterior aspects of the implant contact the capsule wall at radial distance X to mitigate implant migration. Mathematical modeling may be used to determine the height (H) of the lens capsule at any given radial distance (X) from the visual axis 37 along the equatorial plane.

[0025] The total height H is the front height (H A ) and rear height (H P ) and the front height (H A ) is the equation H A =Y-(R A -T A ) may be given by R A and T A is experimentally known, but the distance from the equatorial plane (Y) is given by the equation Y = (R A 2 -X 2 Combining these equations, the forward height may be given by H A =(R A 2 -X 2 )^0.5-(R A -T A ) or can be solved using experimental data. P ) is the rear radius (R P ) and rear thickness (T P ) may be used for similar calculations, or it may be solved using data obtained through experiments. A ) to rear height (H P) gives the total height (H) at a distance (X) from the visual axis. Thus, the desired height (H) of the intraocular implant at a radial distance X may be estimated so that the implant is tangent to the anterior and posterior walls of the lens capsule. Other mathematical models described in the same document may also be used.

[0026] In the following detailed description, various embodiments of modular and non-modular IOL systems are described, and features described with respect to any one embodiment may be applied and incorporated in other embodiments.

[0027] 3A, when assembled, base 400 and lens 500 form one embodiment of modular IOL 300. A general description of modular IOL 300 follows. Further details are provided in U.S. Provisional Patent Application No. 62 / 318,272, which is incorporated herein by reference in its entirety.

[0028] 4A-4D, the base 400 is shown in detail. Figure 4A is a perspective view, Figure 4B is a top view, Figure 4C is a cross-sectional view along line AA in Figure 4B, and Figure 4D is a detailed cross-sectional view of circle C in Figure 4C. Dimensions (mm) are given by way of example and are not necessarily limiting.

[0029] The base 400 includes an annular ring 402 that defines a central bore 404. A pair of haptics 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 may be inserted to form the modular IOL 300.

[0030] The upper edge 410 of the annular ring 402 may include one or more notches 416, which provide an entry point for a probe (e.g., a Sinske hook) to make the base 400 easier to manipulate during surgery. The support 406 may include a hole 415 near the annular ring 402 for the same purpose as the notches 416. A pair of squared edges 417 may extend along the posterior periphery of the annular ring 402 to aid in reducing cellular growth on the lens 500 (posterior capsular opacification, or PCO).

[0031] 4D , the deep portion of the recess 412 may have a square shape defined by a horizontal rear surface 418, a horizontal front surface 420, and vertical side or outer surfaces 422. The recess may also include a flared front surface 426 extending radially inward and forward outward from the horizontal front surface 420, and a flared rear surface 428 extending radially inward and rearward from the horizontal rear surface 418. The inner diameter of the trailing edge 408 may be smaller than the inner diameter of the leading edge 410. With this configuration, the lens 500 may be placed through the circular opening defined by the leading edge 410 to seat or rest on the trailing edge, and the flared front wall 426, together with the flared rear wall 428, may act as a funnel to guide the tabs 504 and 506 of the lens 500 into the deep portion of the recess 412. Once fully seated within recess 412, horizontal rear wall 418, horizontal front wall 420, and vertical side walls 422 form a shape that mates with corresponding horizontal and vertical surfaces of tabs 504 and 506, limiting forward, rearward, and radial movement of lens 500 relative to base 400.

[0032] As best seen in FIG. 4D, the base 400 has a front-to-rear height H=H A +H P where H is about 1 mm, H A is about 0.5 mm at a radial distance of about 3.2 mm from the center point CP, and H P is approximately 0.5 mm at a radial distance of 2.65 mm from the center point CP. However, as mentioned above, the posterior thickness T Pis the anterior thickness T of the natural lens 30 A For this reason, these relative dimensions may be adjusted. For example, H is adjusted so that the sagittal midplane MP of base 400 is aligned (+ / - 0.5 mm) with the equatorial plane of lens 30 when modular IOL 300 is implanted in the capsular bag. P H A It may be made larger than H. A / H P The ratio may be constant, for example, at about 0.7 (±0.3). Additionally, H may be selected such that, when implanted within the capsular bag, the anteriormost portion of the leading edge 410 is very close (within 0.5 mm) to the anterior surface 33 of the lens 30, and the posteriormost portion of the posterior edge 408 is very close (within 0.5 mm) to the posterior surface 35 of the lens 30. Thus, for example and without limitation, H A may be about 0.5 mm to 1.0 mm at a radial distance of about 2.75 mm to 3.25 mm from the center point CP, and H P may be about 0.75 mm to 1.5 mm at a radial distance of 2.25 mm to 2.50 mm from the center point CP, for example, a constant H of about 0.7 (±0.3). A / H P Maintain the ratio.

[0033] 5A-5E, lens 500 is shown in detail. Figure 5A is a perspective view, Figure 5B is a top view, Figure 5C is a cross-sectional view along line AA in Figure 5B, Figure 5D is a detailed cross-sectional view of circle B in Figure 5C, and Figure 5E is a detailed top view of circle C in Figure 5B. Dimensions (mm) are given by way of example and are not necessarily limiting.

[0034] The lens 500 may include an optic portion 502 and one or more tabs 504 and 506. As shown, the tab 504 is fixed while the tab 506 may be movable. The fixed tab 504 may include a through hole 208 whereby a probe (e.g., a Sinske hook) or similar instrument may be used to engage the hole 208 and manipulate the tab 504. The movable tab 506 may be actuated between a compressed position for delivery into the hole 404 of the base 400 and an extended, uncompressed position (as shown) for placement into the recess 412 of the base 400 and thus forming a mating connection between the base 400 and the lens 500. It is also envisioned that the movable tab 506 may be inserted into the recess 412 and actuated between a compressed position to facilitate entry of the fixed tab 504 into the recess 412 and an extended, uncompressed position for further insertion of the fixed tab 504 into the recess 412 and thus forming a mating connection between the base 400 and the lens 500.

[0035] The movable tab 506 may include two members 510 and 512, one end of each connected to the edge of the optic 502 and the other end free, thus forming two cantilever springs. A lip 514 may extend along the periphery of the optic 502 and terminate away from the springs 510 and 512, so that the springs 510 and 512 can fully compress against the edge of the optic 502. The outer diameter of the lip 514 of the lens 500 may be larger than the inner diameter of the trailing edge 408 of the base 400, so that the lens 500 does not fall out of the opening 404 of the base 400, and the lens 500 is supported circumferentially by the trailing edge 408 of the base 400 along its periphery. A gusset with a guide hole 516 may be disposed between the two members 510 and 512, which facilitates manipulation by a probe. Similarly, a guide hole 508 may be provided in the locking tab 504 to provide an entry point for a probe (e.g., a Sinske hook) or similar instrument to manipulate the tab 504 into the recess 412 in the base 400. A notch 518 may be provided in the locking tab 504 to provide an asymmetry that provides a visual indication that the front is up (as opposed to down) when the notch is in a counterclockwise direction relative to the hole 508.

[0036] As seen in FIG. 5C, the anterior and posterior sides of the optic 502 may have a convex radius corresponding to the desired optical power (diopter) of the optic. The locking tabs 504 and spring tabs 510 and 512 may have a flared cross section as shown. More specifically, and as can be seen better from the detailed view shown in FIG. 5D, the locking tabs 504 extend radially outward from the optic 502 from a thinner inner portion 504B to a flared thicker outer portion 504A. A hole 508 may extend through the thinner inner portion 504B. The outermost shape of the thicker portion 504A has a square shape with anterior and posterior horizontal planes and side or outer vertical planes that mate with the recess 412 as described above to minimize anterior-posterior and radial / lateral movement of the lens 500 relative to the base 400. Thicker portion 504A also provides better engagement with the injector plunger, making lens 500 less likely to become stuck in the injector. Thinner portion 504B also provides a forward and rearward offset from the surfaces defining recess 412 in base 400, thereby reducing adhesion between lens 500 and base 400. The same flared configuration and associated benefits apply to each of spring tabs 510 and 512, as shown.

[0037] Commercially available IOLs typically have an equatorial diameter (excluding haptics) of approximately 6 mm, an anterior-posterior thickness of approximately 0.2 mm at the 6 mm diameter and 0.7 mm at the center, and an overall volume of approximately 12 mm. 3 The lens 500 is of similar dimensions, but the base 400 provides a substantially larger volume. The base 400 has an equatorial diameter (excluding haptics) of about 7.8 mm, a front-to-back thickness of about 1 mm, and an overall volume of about 26 cubic millimeters when the lens is placed in the base [13.4 mm for the base]. 3 , support part is 12.5mm 3

[0036] The size of the assembled modular IOL 300 is therefore much larger in volume than conventional IOLs available on the market. This relatively large volume allows the capsular bag to fill more like a natural lens, thus increasing the stability of the base 400 and lens 500 and reducing post-operative displacement due to capsular bag collapse around the base 400. By way of comparison, a corresponding 180 mm 3 For a volume of 130 mm, a typical natural lens has an equatorial diameter of about 10.4 mm and an anterior-posterior dimension of about 4.0 mm. Due to anatomical variations, the volume of the natural lens may be as large as 130 mm. 3 ~250mm 3 Thus, modular IOL 300 (base 400 and lens 500) occupies more than 10% (approximately 20%-10.4%) of the volume of the capsular bag after the natural lens has been extracted, whereas a conventional IOL occupies less than 10% (approximately 10%-5%) of the volume of the lens. In other words, modular IOL 300 uses approximately twice the volume of the capsular bag as a conventional IOL.

[0038] Additionally, compared to conventional IOLs, modular IOL 300 provides a relatively large diameter and rigid platform that resists distortion (i.e., increased stiffness in the sagittal plane for improved anterior-posterior stability) due to the annular ring 402 of base 400. Combined with the relatively long arc of haptics 406 that provides a significantly increased relative surface contact with the capsular bag, modular IOL 300 provides superior centering and stability within the capsular bag.

[0039] The ability to withstand distortion was demonstrated in bench tests comparing the performance of the modular IOL 300 to that of a commercially available IOL (Alcon model A60), the results of which are shown in FIG. 3B. In the test setup, the test IOL was placed in a simulated lens capsule with an inner diameter of 10 mm, and the assembly was submerged in a warm bath. Various loads were applied to the center of the test IOL while it was in a horizontal orientation, and the resulting downward displacement was measured. As can be seen from the results shown in FIG. 3B, the commercially available IOL displaced approximately five times the amount that the modular IOL 300 displaced, and the commercially available IOL failed to support a load of 0.058 grams as its haptics were displaced out of the simulated lens capsule. This demonstrates a significant relative increase in stiffness of the modular IOL 300 compared to a typical commercially available IOL.

[0040] This test setup is eq Δx, where F = applied force, k eq The equivalent stiffness can be compared to a mechanical model of a central load on a beam with two simple supports, where Δx = equivalent stiffness and Δx = displacement. The equivalent stiffness takes into account the cross-sectional moment of inertia of the beam and the material properties of the beam (Young's modulus). However, because the IOL is made of plastic (rather than an elastic material such as metal), the equivalent stiffness varies over the range of applied forces. In the bench tests described, the modular IOL 300 had an equivalent stiffness of about 0.5-2.0 g / mm over a range of applied loads of 0.032-0.100 g, while the commercially available IOL had an equivalent stiffness of about 0.15-0.20 g / mm over a range of applied loads of 0.032-0.044 g.

[0041] In general, when the base 400 and the lens 500 are assembled to form the modular IOL 300, these features may be configured such that the central plane of the optic 502 is parallel to the central plane of the base 400 and the central (anterior-posterior) axis of the optic 502 coincides with and is collinear with the central (anterior-posterior) axis of the base 400. Assuming that the natural lens capsule is anatomically symmetrical and the base 400 is centralized within the lens capsule, this configuration essentially aligns the central axis of the optic 502 with the central (anterior-posterior) axis of the lens capsule, centering the optic 502. However, there are cases where the visual axis (foveal axis) does not align with the anatomical axis (pupil centerline), and this difference is referred to as the kappa angle. In such instances, it may be desirable to provide offset by shifting the central axis of the optic 500 relative to the base 400. This may be achieved, for example, by configuring tabs 504 and 506, recesses 412 and / or support portions 406 such that the central (anterior-posterior) axis of the optical portion 502 is offset laterally (toward the nose or toward the temple) relative to the central (anterior-posterior) axis of the base 400.

[0042] For example, but not by way of limitation, the sidewalls defining the recess 412 of the base 400 may be offset relative to the haptic 406, thereby offsetting the central axis of the optic 502. For example, different offsets may be provided, ranging from 0.5 mm to 2.0 mm in 0.5 mm intervals. Angular orientation marks may be provided on the base 400 and the lens 500, indicating the direction of offset (nasal or temple). Similarly, the mid-plane of the assembled base 400 and optic 500 may be tilted relative to the equatorial plane of the natural lens capsule. To compensate for this tilt, for example, the tabs 504 and 506, the recess 412 and / or the haptic 406 may be configured such that the mid-plane of the optic 502 is tilted in the opposite direction.

[0043] The base 400 and lens 500 may be formed by cryogenically cutting and grinding a hydrophobic acrylic material, including the alternative embodiments described herein. Optionally, the base 400 may be manufactured by forming two pieces (front and back) and connecting them together with an adhesive. For example, the two pieces may be cryogenically cut from hydrophilic acrylic connected together with a UV-curable adhesive. Alternatively, the two pieces may be formed from different materials that are connected together with an adhesive. For example, the front piece may be formed from a hydrophilic acrylic that does not adhere to ocular tissue, and the back piece may be formed from a hydrophobic acrylic that adheres to ocular tissue.

[0044] As another alternative, the base 400 may be manufactured by cryogenically machining a first piece and overmolding a second piece. The first piece may include features that mate together when overmolded, thus eliminating the need for adhesives to connect the pieces. For example, the base 400 may be manufactured by cryogenically machining a hydrophilic acrylic to form a rear piece and overmolding a front piece of a moldable material such as silicone.

[0045] Although the hydrophobic acrylic resin allows the base 400 and lens 500 to be visualized using optical coherence tomography (OCT), it may be desirable to incorporate a material that enhances 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 sold under the brand name RADEL™, 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 may be applied to or incorporated into portions of the base 400 or lens 500.

[0046] For example, concentric rings of OCT-preferred material may be applied to each of the lower and upper edges 408 / 410. The rings may have different diameters to aid in detecting tilt of the base. Also, for example, OCT-preferred material may be applied to tabs 504 / 506 of lens 500. This may aid in determining whether the base 400 and lens 500 are properly assembled in the eye. Dots of OCT-preferred material may be applied to portions of base 400 that align with corresponding OCT-preferred dots on optic 500, indicating proper assembly in the eye.

[0047] Instead of a solid material, the base 400 and the lens 500 may be made of a hollow material that can be later inflated in the eye. In this configuration, the base 400 and the lens 500 may be made of molded silicone, for example, and inflated with a liquid, such as saline, silicone gel, etc., using a syringe and needle. The needle may pierce the walls of the base 400 and the lens 500 after implantation in the eye, causing these components to inflate. The material may self-seal when the needle is removed. Instead of a hollow material, the base 400 and the lens 500 may be made of a sponge-like material, such as silicone hydrogel, that expands when water is added. Either approach may reduce the size of the corneal incision, since the base 400 and the lens 500 are delivered in an uninflated or unexpanded state and then inflated or expanded once placed in the eye.

[0048] In general, a modular IOL 300 that includes an assembled base 400 and lens 500, including alternative embodiments described herein, allows the lens 500 to be adjusted or replaced either intraoperatively or postoperatively while the base 400 remains in place. Examples of when this may be desirable include, but are not limited to, replacing the lens 500 to correct a suboptimal refractive result detected intraoperatively, replacing the lens 500 to correct a suboptimal refractive result (residual refractive error) detected postoperatively, adjusting the lens 500 rotationally with respect to the base 400 to fine-tune the toric correction, adjusting the lens 500 laterally with respect to the base 400 to align the optic with the true optical axis (which may not be the center of the capsular bag), and replacing the lens 500 to accommodate the changing optical needs or desires of a patient over time. Examples of this case include, but are not limited to, adult or pediatric IOL patients whose initial optical correction needs change with age or growth, patients who wish to upgrade from a monofocal IOL to a premium IOL (lens technology with toric, multifocal, accommodative or other features) and who are dissatisfied with their premium IOL and wish to downgrade to a multifocal IOL, and patients who have developed a medical condition that contraindicates an IOL or a particular type of IOL.

[0049] 6A and 6B, an alternative modular IOL 330 is shown in perspective and cross-sectional views, respectively. The alternative modular IOL 330 may include an alternative base 600 and lens 500 as described above. As will be appreciated from the following description, the alternative base 600 may be similar to the base 400, except for a leading edge 610 and a trailing edge 608, and the description of similar aspects and advantages is incorporated herein by reference. The alternative base 600 includes an annular ring defining a central bore. 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 inwardly facing recess 612 into which the lens 500 may be inserted to form the modular IOL 330.

[0050] 6B, the lower edge 608 and the upper edge 610 may have a relatively exaggerated height and may angle radially inward to form a funnel that leads to a recess 612. With this arrangement, the actuatable tab 506 of the lens may be compressed and the lens 500 may be placed through the circular opening defined by the leading edge 610, with the funnel shape of the leading edge 610 guiding the tabs 504 and 506 into the recess 612 of the base 600 and forming a mating shape to limit forward, rearward and radial movement of the lens 500 relative to the base 600. The funnel shape of the trailing edge 608 prevents the lens 500 from falling rearward during insertion of the lens 500 into the base 600.

[0051] The base 600 may have dimensions shown as examples, but are not necessarily limiting. As best seen in FIG. 6B, the edges 608 and 610 of the base 400 may have a combined anterior-posterior height of 2.0-3.0 times (or more) the maximum thickness of the optic portion 502 of the lens 500. For example, the combined height of the edges 608 and 610 at a radial distance of about 2.9 mm from the center point may be about 3 mm. As mentioned above, the height of the posterior edge 608 may be made higher than the height of the anterior edge 610 such that the sagittal midplane of the base 600 is aligned (+ / - 0.5 mm) with the equatorial plane of the lens 30 when the modular IOL 330 is implanted in the capsular bag. The ratio of the height of the anterior edge 610 to the posterior edge 608 may be constant at a value less than 1.0, such as about 0.7 (± 0.3). As shown, the combined height of leading edge 610 and trailing edge 608 is selected so that when implanted within the lens capsule, the front-most portion of leading edge 610 is very close (within 0.5 mm) to or pressed against the anterior surface 33 of the lens 30, and the rear-most portion of trailing edge 608 is very close (within 0.5 mm) to or pressed against the posterior surface 35 of the lens 30.

[0052] 7A and 7B, an alternative base 700 for use with a conventional IOL 100 is shown in perspective views, with FIG. 7A showing the base 700 alone and FIG. 7B showing the base 700 assembled in combination with a conventional IOL 100 to form a modular IOL 360. The alternative base 700 is similar to the base 400 described above, with the exception of the inverted T-slot 730, and a description of similar aspects and advantages is incorporated herein by reference.

[0053] The base 700 includes an annular ring 702 that defines a central hole 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 inwardly facing recess 712 into which a conventional IOL 100 may be inserted to form a modular IOL 360. The upper edge 710 of the annular ring 702 may include one or more notches 716 for providing access for a probe (e.g., a Sinske hook) during surgery, thereby allowing the base 700 to be more easily manipulated. The haptics 706 may include a hole 715 adjacent the annular ring 702 for the same purpose as the notches 716.

[0054] The annular ring 702 may include a pair of inverted T-shaped slots 730 for receiving symmetrically opposed haptics 106 of a conventional IOL 100. When the haptics 106 of the conventional IOL 100 are placed in the slots 730, the posterior aspect of the optic portion 102 of the conventional IOL 100 may rest on the anterior surface of the posterior edge 708. The posterior portion of the slot 730 may have a greater width than its anterior portion to accommodate the angle of the haptics 106 and to lock the IOL 100 to the base 700 when the IOL 100 is rotated relative to the base 700. The addition of the base 700 adds anterior-posterior stiffness and height to the conventional IOL 100, thereby improving its stability.

[0055] 8A-8C, which are respectively a perspective view, a cross-sectional view, and a top view of a non-modular IOL 800, which is shown in a schematic manner. The non-modular IOL 800 incorporates some of the stability advantages discussed above in a non-modular configuration. The IOL 800 includes an optic portion 802, which may be, for example, monofocal (fixed focal length), accommodative (variable focal length), toric, multifocal, or an extended depth of focus pattern. The IOL 800 also includes two or more haptics 806 extending radially outward from the periphery of the optic portion 802. Each haptic includes a posterior flange 808 and an anterior flange 810 that extend radially inward from an outer edge 809 and flares respectfully outwardly posteriorly and outwardly anteriorly. Each haptic 806 includes a connecting arm 812 that connects the outer edge 809 to the periphery of the optic portion 802. Each connecting arm 812 may include a window 814 for added flexibility. Aft flange 808 and forward flange 810 are configured to compress against each other in the fore-aft direction and act like a cantilever leaf spring about outer edge 809 .

[0056] With particular reference to Figure 8B, which is a cross-sectional view taken along line BB of Figure 8A, it can be seen that posterior flange 808 is sized and configured differently from anterior flange 810 to conform to the shape of the lens capsule. As discussed above, the posterior thickness of the natural lens is greater than the anterior thickness of the natural lens. In order for the anterior flange 810 to conform to the anterior aspect 33 of the lens capsule and for the posterior flange 808 to conform to the posterior aspect 35 of the lens capsule, the anterior flange 810 is sized and configured differently from the posterior height H P and the front height H is smaller than the arc length A For example, H may have an arc length 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 equatorial plane of the capsular bag. P H A It may be made larger than H. A / H P The ratio may be constant, for example, at about 0.7 (±0.3).

[0057] 8B and 8C, the radial length (in the sagittal plane) of the posterior flange 808 and the anterior flange 810 may be selected such that the innermost edge does not obstruct the field of view of the optic 802. In other words, the posterior flange 808 and the anterior flange 810 may extend radially inward from the outer edge 809 to the outer diameter of the optic 802, with the inner edges of the posterior flange 808 and the anterior flange 810 forming an arc that matches the outer diameter of the optic 802. The outer edge 809 may also form an arc, with the haptics 806 matching the circular shape of the equator of the natural lens capsule. For example, but not necessarily limiting, the arc shape of the haptics 806 may extend 60°-90°, 90°-120°, or 120°-150° of the circumference of the optic 802. The greater the arc length of the haptics, the greater the contact area with the equator of the natural capsular bag and the greater the stability of the IOL800 within the capsular bag, but this must be balanced with the deliverability of the IOL800 through a small incision using an injector.

[0058] 9A and 9B, alternative non-modular IOLs 900 and 950 are shown in perspective views, respectively. IOLs 900 and 950 are similar to IOL 800 described above in that the haptics include flared flanges for improved stability, and a description of similar aspects and advantages is incorporated herein by reference.

[0059] With particular reference to FIG. 9A , the IOL 900 includes an optic portion 902, which may be, for example, monofocal (fixed focal length), accommodative (variable focal length), toric, multifocal, or an extended depth of focus pattern. The IOL 900 also includes two or more haptics 906 extending radially outward from the periphery of the optic portion 902. Each haptic 906 includes a posterior flange 908 and an anterior flange 910 that extend radially inward from an outer edge 909 and flares respectfully lateral posteriorly and lateral anteriorly. Each haptic 906 includes a pair of connecting arms 912 that connect the outer edge 909 to the periphery of the optic portion 902. Each of the pair of connecting arms 912 may include a window 914 for added flexibility. The posterior flanges 908 and anterior flanges 910 are configured to compress against each other in the anterior-posterior direction, acting like a cantilever leaf spring around the outer edge 909. In comparison to IOL 800, the flanges 908 and 910 of IOL 900 have a smaller radial length (in the sagittal plane) extending from the outer edge 909 to the optic 902. In addition, a gap 911 is provided between the connecting arms 912 and the flanges 908 and 910 along the internal connection to the outer edge 909 to provide space for the flanges 908 and 910 to compress and fold towards the optic 902. The gap 911 allows the connection between the outer edge 909 and the flanges 908 and 910 to function as an elastic hinge, and allows the flanges 908 and 910 to better conform to the inside of the capsular bag wall, which may vary in size and dimensions.

[0060] 9B, IOL 950 is similar to IOL 900, and a description of similar aspects and advantages is incorporated herein by reference. IOL 950 includes one or more haptics 906 including curved arms 916 (rather than connecting arms 912) that extend from the periphery of optic 902 to form an outer edge 909 from which extend flanges 908 and 910. As with the previous embodiment, gaps 911 are provided along outer edge 909 to enhance flexibility of flanges 908 and 910 relative to curved arms 916, such that the connections between curved arms 916 and flanges 908 and 910 function as elastic hinges.

[0061] 10A and 10B, an alternative non-modular IOL 1000 is shown diagrammatically. FIG. 10A is a top view of the IOL 1000, and FIG. 10B is a cross-sectional view taken along line BB of FIG. 10A. The IOL 1000 includes an optic portion 1002, which may be, for example, monofocal (fixed focal length), accommodative (variable focal length), toric, multifocal, or an extended depth of focus pattern. The IOL 1000 also includes a pair of haptics 1006 extending outwardly from the optic portion 1002. A pair of gusset plates 1004 connect the haptics 1006 to the optic portion 1002. While conventional IOLs provide haptics extending from the optic portion, the IOL 1000 uses the gusset plates 1004 to push the attachment points of the haptics 1006 radially outward, thereby increasing the relative anterior-posterior stiffness of the IOL in the sagittal plane. The IOL 1000 also includes haptics 1006 and ridges 1008 extending posteriorly around the periphery of the optic 1002 and the periphery of the gusset plate 1004, except where the haptics 1006 and gusset plate 1004 join. The ridges 1008 increase the cross-sectional moment of inertia of the IOL 1000 in the sagittal plane, thereby increasing the stiffness and stability of the IOL 1000 without affecting the flexibility of the haptics 1006. As seen in cross section, the ridges 1008 may have inner fillets and outer squared edges to inhibit cellular growth on the optic 1002, as shown. For example, and not necessarily limiting, the haptics may have an outer length of 13 mm (from haptic tip to haptic tip), the optic may have a diameter of 5 mm to 6 mm, and the gusset plate 1004 may have an average sagittal width of 1 mm to 2 mm. Therefore, in an optical section 1002 with a diameter of 5.0 mm, the support section 1006 may be attached to a gusset plate 1004 with a diameter of 7.0 mm to 9.0 mm.

[0062] 11A and 11B, another alternative non-modular IOL 1100 is shown in schematic form. FIG. 11A is a top view of the IOL 1100, and FIG. 11B is a cross-sectional perspective view taken along line BB of FIG. 11A. As will be appreciated from the following description, the IOL 1100 may be similar to the IOL 1000, except with respect to the ridges 1108. The description of similar aspects and advantages is incorporated herein by reference. The IOL 1100 includes an optic portion 1102, which may be, for example, monofocal (fixed focal length), accommodative (variable focal length), toric, multifocal, or an extended depth of focus pattern. The IOL 1102 also includes a pair of haptics 1106 extending outwardly from the optic portion 1102. A pair of gusset plates 1104 connect the haptics 1006 to the optic portion 1102. While conventional IOLs provide haptics extending from the optic, the IOL 1100 uses gusset plates 1104 to push the attachment points of the haptics 1106 radially outward, thereby increasing the relative anterior-posterior stiffness of the IOL in the sagittal plane. The IOL 1100 also includes a ridge 1108 that extends around the periphery of the optic 1102 and extends both anteriorly and posteriorly. The ridge 1108 increases the cross-sectional moment of inertia of the IOL 1100 in the sagittal plane, thereby increasing the stiffness and stability of the IOL 1100 without affecting the flexibility of the gusset plates 1104 or the haptics 1106. As seen in cross section, the ridge 1108 may be elliptical and rounded.

[0063] 12A and 12B, yet another alternative non-modular IOL 1200 is shown generally. FIG. 12A is a top view of the IOL 1200, and FIG. 12B is a cross-sectional view taken along line BB of FIG. 12A. As will be appreciated by the following description, the IOL 1200 may be similar to the IOL 1000, except with respect to the gusset or support portion 1204 and one or more ridges 1208. The description of similar aspects and advantages is incorporated herein by reference.

[0064] The IOL 1200 includes an optic portion 1202, which may be, for example, monofocal (fixed focal length), accommodative (variable focal length), toric, multifocal, or an extended depth of focus pattern. The IOL 1200 also includes a pair of haptics 1206 extending outwardly from the optic portion 1202. The haptics 1204 or support portions 1204 support the optic portion 1202. 02 1202 and connects haptics 1206 to optic portion 1202. Whereas conventional IOLs provide haptics extending from the optic portion, IOL 1200 uses support portions 1204 to push the attachment points of haptics 1206 radially outward, thereby increasing the anterior-posterior stiffness of IOL 1200 relatively in the sagittal plane.

[0065] The support portion 1204 may surround the optic 1202. For example, the support portion 1204 may extend a full 360° concentrically around the radially outer periphery of the optic 1202. In one example, the support portion 1204 may include an annular plate forming a band around the optic 1202. The plate may have a substantially constant width between its inner and outer circumferences.

[0066] The support portion 1204 may include a forward facing surface 1204a and a rearward facing surface 1204b. At least one of the forward facing surface 1204a and the rearward facing surface 1204b of the support portion 1204 may extend substantially perpendicular to the optical axis 1202a of the optic portion 1202. The optic portion 1202 may have a curved forward facing surface 1202b and / or a curved rearward facing surface 1202c. An annular concave region 1203 may be formed on the anterior and / or posterior side of the IOL 1200, in which the support portion 1204 abuts the optic portion 1202 by an angle between the forward-facing surfaces 1204a and 1202b, respectively, of the support portion 1204 and the optic portion 1202 and / or an angle between the rearward-facing surfaces 1204b and 1202c, respectively, of the support portion 1204 and the optic portion 1202.

[0067] The thickness of the support portion 1204, measured between the anterior facing surface 1204a and the posterior facing surface 1204b of the support portion 1204, may be substantially equal to the radially outer peripheral thickness of the optic 1202 (measured between the periphery of the anterior facing surface 1202b and the periphery of the posterior facing surface 1202c of the optic 1202). Additionally or alternatively, the thickness of the support portion 1204 may be substantially equal to the thickness of the haptic 1206 (measured between the anterior facing surface 1206a and the posterior facing surface 1206b of the haptic 1206).

[0068] The IOL 1200 may also include one or more protuberances or ridges 1208. The one or more ridges 1208 may extend beyond the support portion 1204. and support portion 1206 The radially outer periphery of Part Around or along one or more parts 、 In one example, the one or more ridges 1208 may include one or more ridges extending forwardly from the forward-facing surface 1204a of the support portion 1204. For example, the one or more forwardly extending ridges may include ridge 1208a and / or ridge 1208b. Including Additionally or alternatively, the one or more ridges 1208 may include one or more ridges extending posteriorly from the rear-facing surface 1204b of the support portion 1204. For example, the one or more posteriorly extending ridges may include ridge 1208c and / or ridge 1208d. The one or more ridges 1208 may increase the cross-sectional moment of inertia in the sagittal plane of the entire IOL 1200, including the optic 1202, the support portion 1204, and the haptics 1206, thereby increasing its stiffness and stability. Although FIGS. 12A and 12B show a pair of anteriorly extending ridges 1208a and 1208b and a pair of posteriorly extending ridges 1208c and 1208d, it is contemplated that fewer ridges may be used. For example, IOL 1200 may include only anteriorly extending ridges 1208a and 1208b or only posteriorly extending ridges 1208c and 1208d.

[0069] As seen in the cross-sectional view of FIG. 12B, one or more of the ridges 1208 may have a square shape to reduce cell growth on the optic 1202. For example, one or more of the ridges 1208a, 1208b, 1208c, and 1208d may include opposing surfaces 1208e and 1208f that extend substantially perpendicular to the front-facing surface 1204a and / or the rear-facing surface 1204b of the support portion 1204. Additionally or alternatively, the opposing surfaces 1208e and 1208f may extend substantially parallel to one another. Additionally or alternatively, one or more of the ridges 1208a, 1208b, 1208c, and 1208d may include an end surface 1208g that extends substantially parallel to the front-facing surface 1204a and / or the rear-facing surface 1204b of the support portion 1204. Surface 1208f may be flush with a radially outer peripheral surface of support portion 1204 and / or support portion 1206.

[0070] Ridge 1208a may extend on, along, or around an outer curved portion of one of the supports 1206 and may taper (e.g., decrease in height) at or near the tip of the support 1206. The tapered portion may define a first end of ridge 1208a. Ridge 1208a may have a second end opposite its first end. The second end may taper (e.g., decrease in height). The tapering of the second end of ridge 1208a may have a greater slope than the tapering of the first end. Ridges 1208b, 1208c, and 1208d may be similarly shaped.

[0071] Ridges 1208a, 1208b, 1208c, and 1208d may have a height (measured in an anterior-posterior direction relative to a surface of support portion 1204) between their tapered ends such that anterior-facing surface 1202b of optic 1202 may extend in front of ridge 1208a and / or ridge 1208b, and / or posterior-facing surface 1202c of optic 1202 may extend posterior to ridge 1208c and / or ridge 1208d. It is also contemplated that one or more of ridges 1208a, 1208b, 1208c, 1208d may have a constant height between their tapered ends.

[0072] As best seen in FIG. 12A, ridges 1208a and 1208b may be separate ridges separated by a gap. Additionally or alternatively, ridges 1208c and 1208d may be separate ridges separated by a gap. For example, ridges may be eliminated from the inner curvature of haptics 1206 to allow radial compression of haptics 1206 onto optic portion 1202.

[0073] The ridge 1208a may include a first curved portion 1208h and a second curved portion 1208i. The first curved portion 1208h and the second curved portion 1208i may be substantially concave when viewed in a perspective view of the optic portion 1202. Where the first curved portion 1208h and the second curved portion 1208i meet, they may form a convex portion 1208j of the ridge 1208a. The ridges 1208b, 1208c and / or 1208d may be similarly shaped.

[0074] One or more of the ridges 1208 may be arranged in pairs. For example, ridges 1208a, 1208b may form a first anterior pair or ridges, and / or ridges 1208c, 1208d may form a second posterior pair of ridges. With respect to the pair of ridges 1208a and 1208b, an end portion of one of the ridges may extend beyond the opposite end portion of the other ridge toward a middle portion of the other ridge. A similar configuration may exist for the pair of ridges 1208c and 1208d.

[0075] 13A-13C, various alternative non-modular IOLs 1300A, 1300B, and 1300C are shown in perspective views. Each IOL 1300 includes an optic portion 1302, which may be, for example, monofocal (fixed focal length), accommodative (variable focal length), toric, multifocal, or extended depth of focus pattern. Each IOL 1300 also includes two or more haptics 1306 connected to the optic portion 1302 via connecting arms 1312. Compared to conventional IOLs in which the haptics are curvilinear and provide a radial spring force in addition to contact with the inner equator of the lens capsule, the connecting arms 1312 provide a radial spring force independent of the haptics 1306, which may be annular to maintain the same amount of contact area with the inner equator of the lens capsule independent of radial compression of the connecting arms 1312. This configuration provides more consistent stability of the IOL 1300 within the capsule regardless of capsule size. For example, the haptics 1306 may extend 60°-90°, 90°-120°, or 120°-150° of the periphery of the optic 1302 and may have a consistent radius of approximately 4.0-5.0 mm. The connecting arms 1312 may be in the form of, for example, a multi-bar cantilever (zigzag) spring 1312A, a single bar cantilever (curved) spring 1312B, or a multiple leaf spring 1312C.

[0076] The above description of the disclosure has been presented for purposes of illustration and description. The above is not intended to limit the disclosure to the form(s) disclosed herein. Although the disclosure includes one or more embodiments and descriptions of certain variations and modifications, other variations and modifications, such as those that become part of the skill and knowledge of those skilled in the art after appreciating the present disclosure, are also within the scope of the disclosure. The intention is to obtain the right to include alternative embodiments, including alternative, interchangeable, and / or equivalent structures, functions, ranges, or steps, in what is claimed to the fullest extent possible, regardless of whether such alternative, interchangeable, and / or equivalent structures, functions, ranges, or steps are disclosed herein, and without the intention of dedicating any patentable subject matter to the public. (Additional Note) As a preferred embodiment, the technical ideas that can be understood from the above embodiment will be described below. [Item 1] An intraocular lens, an optical portion defining an optical axis extending in a front-to-rear direction; a support portion extending radially outward from a periphery of the optical portion; a support portion extending radially outward from the support portion; A protuberance extending in the front-rear direction from the periphery of the support portion; 4. An intraocular lens, comprising: [Item 2] 2. The intraocular lens of claim 1, wherein the ridge extends only posteriorly from the periphery of the support portion. [Item 3] The intraocular lens described in Item 1, wherein the ridge extends only forward from the periphery of the support portion. [Item 4] 2. The intraocular lens of claim 1, wherein the protuberance extends along a radially outer periphery of the haptic and tapers toward a tip of the haptic. [Item 5] 2. The intraocular lens of claim 1, wherein the protuberance is a first protuberance, and the intraocular lens includes a second protuberance extending in the anterior-posterior direction from the periphery of the support portion. [Item 6] Item 6. The intraocular lens of item 5, wherein the first ridge and the second ridge are distinct in that they are separated by a gap. [Item 7] 6. The intraocular lens of claim 5, wherein the first ridge extends anteriorly from the periphery of the support portion and the second ridge extends posteriorly from the periphery of the support portion. [Item 8] 6. The intraocular lens of claim 5, wherein the first ridge and the second ridge extend only anteriorly from the periphery of the support portion. [Item 9] 6. The intraocular lens of claim 5, wherein the first ridge and the second ridge extend only posteriorly from the periphery of the support portion. [Item 10] An intraocular lens, The optical part, a support portion surrounding a periphery of the optical portion, the support portion including an anterior-facing surface and a posterior-facing surface; a support portion extending radially outward from the support portion; A protuberance extending in the front-rear direction from the periphery of the support portion; 4. An intraocular lens, comprising: [Item 11] Item 11. The intraocular lens of item 10, wherein the support portion includes a continuous annular band surrounding the periphery of the optic portion. [Item 12] Item 11. The intraocular lens of item 10, wherein the support portion has a thickness defined between the anterior facing surface and the posterior facing surface. [Item 13] Item 13. The intraocular lens of item 12, wherein the support portion has a constant thickness throughout. [Item 14] Item 13. The intraocular lens of item 12, wherein the optic portion includes an anterior facing surface and a posterior facing surface and has a thickness defined between the anterior facing surface and the posterior facing surface of the optic portion, the thickness of at least a portion of the optic portion being greater than the thickness of the support portion. [Item 15] Item 11. The intraocular lens of item 10, wherein the optic portion defines an optical axis, and at least one of the anterior-facing surface and the posterior-facing surface of the support portion is substantially perpendicular to the optical axis. [Item 16] Item 11. The intraocular lens of item 10, wherein the ridge includes a radially facing surface that is substantially perpendicular to at least one of the front facing surface and the rear facing surface of the support portion. [Item 17] An intraocular lens, an optic portion having a forward facing surface and a rearward facing surface; a support portion extending radially outward from the optical portion; a plurality of supports extending radially outward from the support portion; and a plurality of separate protuberances extending anteriorly and posteriorly from a periphery of the support portion. [Item 18] Item 18. The intraocular lens of item 17, wherein the plurality of distinct ridges includes a first pair of distinct ridges extending anteriorly from the periphery of the haptic and the periphery of the support portion. [Item 19] Item 19. The intraocular lens of item 18, wherein the plurality of distinct ridges includes a second pair of distinct ridges extending posteriorly from the periphery of the haptic and the periphery of the support portion. [Item 20] The plurality of distinct ridges include: A first protrusion extending in a front-rear direction from the periphery of a first support portion among the plurality of support portions and a first portion of the periphery of the support portion; A second protuberance extending in a front-rear direction from the periphery of a second support portion among the plurality of support portions and a second portion of the periphery of the support portion; Including, The first support portion and the second support portion extend from opposite sides of the support portion at symmetrical positions, and the first portion and the second portion of the periphery of the support portion are on opposite sides of the support portion at symmetrical positions. Item 18. The intraocular lens according to item 17. [Item 21] 1. An intraocular lens system comprising: a. a base including an annular body having a central bore extending within said annular body and defining a recess extending around an inner periphery of said annular body, two supports extending radially outwardly from said annular body, an upper edge extending around a front side of said annular body, and a lower edge extending around a rear side of said annular body, said upper edge and said lower edge angled radially inwardly to form a funnel leading to said recess; b. a lens including an optical portion and two tabs extending radially outward from the optical portion, the lens being disposed in the central hole of the annular body and the tabs being disposed in the recesses; An intraocular lens system comprising: [Item 22] 22. The intraocular lens system of claim 21, wherein the upper edge and the lower edge have a combined height that is at least twice as large as the maximum thickness of the optical portion. [Item 23] 22. The intraocular lens system of claim 21, wherein the upper edge and the lower edge have a combined height that is at least three times greater than the maximum thickness of the optical portion. [Item 24] 22. The intraocular lens system of claim 21, wherein the upper edge and the lower edge extend around the entire circumference of the annular body. [Item 25] 22. The intraocular lens system of claim 21, wherein the height of the posterior edge is greater than the height of the anterior edge. [Item 26] 26. The intraocular lens system of claim 25, wherein the height of the leading edge divided by the height of the trailing edge equals a ratio less than one. [Item 27] 27. The intraocular lens system of claim 26, wherein the ratio is about 0.7. [Item 28] 22. The intraocular lens system of claim 21, wherein the optical portion has a fixed focal length. [Item 29] 1. An intraocular lens system comprising: a. a base including an annular body having a central bore extending within said annular body, defining a rearward inner projection extending around an inner periphery of said annular body, and also defining two slots extending from a front side of said annular body to said rearward inner projection, and two supports extending radially outward from said annular body; b. a lens including an optic portion and two haptics extending radially outward from the optic portion; the lens is disposed in the central bore of the annular body and rests on a front side of the protrusion, the support for the lens being disposed in the slot and extending radially outward from the annular body; Intraocular lens system. [Item 30] An intraocular lens, a. an optical portion; b. two or more arms extending radially outward from a periphery of the optical portion; c. a support extending radially outward from each arm, each support including an outer edge, an aft flange extending radially inward and flaring aft from said edge, and a leading edge extending radially inward and flaring forward from said edge; 4. An intraocular lens, comprising: [Item 31] Item 31. The intraocular lens of item 30, wherein the posterior flange and the anterior flange are configured to compress in an anterior-posterior direction relative to one another and act like a cantilever leaf spring around the outer edge. [Item 32] Item 32. The intraocular lens of item 31, wherein the flange has a total height that is at least twice as large as a maximum thickness of the optic portion. [Item 33] Item 33. The intraocular lens of item 32, wherein the height of the posterior flange is greater than the height of the anterior flange. [Item 34] Item 34. The intraocular lens of item 33, wherein the height of the leading edge divided by the height of the trailing edge equals a ratio less than 1. [Item 35] 35. The intraocular lens according to claim 34, wherein said ratio is about 0.7. [Item 36] 32. The intraocular lens of claim 31 , wherein the optic portion has a fixed focal length. [Item 37] An intraocular lens, a. an optical portion; b. two or more gusset plates extending radially outward from a periphery of the optical portion; c. a support extending radially outward from each gusset plate; d. a ridge extending around an outer periphery of said optical portion and said gusset plate; 4. An intraocular lens, comprising: [Item 38] Item 38. The intraocular lens of item 37, wherein the ridge extends posteriorly. [Item 39] Item 38. The intraocular lens of item 37, wherein the ridge extends anteriorly and posteriorly. [Item 40] Item 38. The intraocular lens of item 37, wherein the ridges extend along the outer periphery of the haptics and taper toward the tip of each haptic.

Claims

1. An intraocular lens, an optical portion defining an optical axis extending in a front-to-rear direction; a support portion extending circumferentially around the optic portion; a support portion extending radially outward from the support portion; a ridge extending along a radially outer periphery of the support portion and a radially outer periphery of the support section; Including, the ridge extends forwardly from a forward-facing surface of the support portion and / or rearwardly from a rearward-facing surface of the support portion; and The protuberance tapers toward the tip of the support.

2. The intraocular lens of claim 1 , wherein the ridge extends only posteriorly from the posterior-facing surface of the support portion.

3. The intraocular lens of claim 1 , wherein the ridge extends only forward from the forward-facing surface of the support portion.

4. the ridge is a first ridge; the intraocular lens includes a second ridge extending along the radially outer periphery of the support portion; The intraocular lens of claim 1 , wherein the second ridge extends anteriorly from the forward facing surface of the support portion and / or posteriorly from the rearward facing surface of the support portion.

5. The intraocular lens of claim 4 , wherein the first ridge and the second ridge are distinct in that they are separated by a gap.

6. the first ridge extends forwardly from the forward-facing surface of the support portion; The intraocular lens of claim 4 , wherein the second ridge extends posteriorly from the posterior-facing surface of the support portion.

7. The intraocular lens of claim 4 , wherein the first ridge and the second ridge extend only forward from the forward-facing surface of the support portion.

8. The intraocular lens of claim 4 , wherein the first ridge and the second ridge extend only posteriorly from the posterior-facing surface of the support portion.

9. An intraocular lens, The optical part, a support portion circumferentially surrounding the optical portion, the support portion including an anterior-facing surface and a posterior-facing surface; a support portion extending radially outward from the support portion; a protuberance extending in a front-to-rear direction along the radially outer periphery of the support portion and the radially outer periphery of the support section; Including, The protuberance tapers toward the tip of the support.

10. The intraocular lens of claim 9 , wherein the support portion comprises a continuous annular band that surrounds the periphery of the optic portion.

11. The intraocular lens of claim 9 , wherein the support portion has a thickness defined between the anterior facing surface and the posterior facing surface.

12. The intraocular lens of claim 11 , wherein the support portion has a constant thickness throughout.

13. 12. The intraocular lens of claim 11, wherein the optical portion includes a front facing surface and a rear facing surface and has a thickness defined between the front facing surface and the rear facing surface of the optical portion, the thickness of at least a portion of the optical portion being greater than the thickness of the support portion.

14. 10. The intraocular lens of claim 9, wherein the optic portion defines an optical axis, and at least one of the anterior-facing surface and the posterior-facing surface of the support portion is substantially perpendicular to the optical axis.

15. The intraocular lens of claim 9 , wherein the ridge includes a radially facing surface that is substantially perpendicular to at least one of the forward facing surface and the rearward facing surface of the support portion.

16. An intraocular lens, an optic portion having a forward facing surface and a rearward facing surface; a support portion extending radially outward from the optical portion; a plurality of supports extending radially outward from the support portion; a radially outer periphery of the support portion and a plurality of discrete ridges extending in a front-to-rear direction along the radially outer periphery of the support portion; An intraocular lens, wherein each of the plurality of discrete ridges tapers toward a tip of each of the plurality of haptics.

17. 17. The intraocular lens of claim 16, wherein the plurality of distinct ridges includes a first pair of distinct ridges extending forwardly from the radially outer periphery of the haptic and a forward-facing surface of the support portion.

18. 18. The intraocular lens of claim 17, wherein the plurality of distinct ridges includes a second pair of distinct ridges extending rearwardly from the radially outer periphery of the haptic and a rearwardly facing surface of the support portion.

19. The plurality of distinct ridges include: a first protuberance extending in a front-to-rear direction from a radially outer periphery of a first support portion of the plurality of supports and a first portion of the radially outer periphery of the support portion; a second protuberance extending in a front-to-rear direction from a radially outer periphery of a second support portion of the plurality of supports and a second portion of the radially outer periphery of the support portion; Including, the first support portion and the second support portion extend from symmetrically opposed sides of the support portion, and the first and second portions of the radially outer periphery of the support portion are on symmetrically opposed sides of the support portion.

17. The intraocular lens of claim 16.

Citation Information

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