Multipart IOL having stable IOL base design to support second optic

Abstract

To provide a multipart IOL having a stable IOL base design to support a second optic.SOLUTION: An intraocular lens (IOL) is configured to support a first optic for functioning as a single lens IOL and configured to support a second optic for functioning as a dual optic IOL. A base includes the first optic for providing a base power. A recess in an anterior rim of the base is configured for positioning a radial extension of the second optic. The geometry of the recess is configured to securely couple to the radial extension to prevent rotation of the second optic relative to the base and prevent tilting of the second optic relative to an optic axis.SELECTED DRAWING: Figure 1

Description

[Technical Field]

[0001] Priority claims This application claims the benefit of priority to U.S. Provisional Patent Application No. 63 / 010,745, entitled "STABLE IOL BASE DESIGN TO SUPPORT SECOND OPTIC," filed April 16, 2020, inventors James M. Scott and Raza Shah, which is incorporated herein by reference in its entirety as if fully and completely set forth herein.

[0002] The present disclosure relates generally to the field of intraocular lenses (IOLs), and more particularly to a base that includes a first optic and can support a second optic as part of a multi-part optical system. [Background technology]

[0003] The human eye functions to provide vision by transmitting light through a clear outer portion called the cornea and focusing an image onto the retina by means 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.

[0004] When the lens becomes less transparent (e.g., cloudy) due to age or disease, vision is impaired because less light can be transmitted to the retina. This defect in the eye's lens is medically known as a cataract. The accepted treatment for this condition is to surgically remove the lens from its capsule and insert an artificial intraocular lens (IOL) into the capsule. In the United States, the majority of cataractous lenses are removed through a surgical technique called phacoemulsification. In this procedure, an opening is made in the anterior part of the lens capsule (capsulotomy), and a thin phacoemulsification cutting tip is inserted into the diseased lens and vibrated with ultrasound. The vibrating cutting tip liquefies or emulsifies the lens, allowing it to be sucked out of the capsule. After removal, the diseased lens is replaced with an IOL.

[0005] Some conventional IOLs are single-focal-length IOLs, while others are multifocal IOLs. A single-focal-length IOL has a single focal length, i.e., a single refractive power. Objects at the focal length from the eye / IOL are in focus, but closer or more distant objects may be out of focus. Objects at the focal length are in perfect focus, but objects within the depth of field (within a certain distance of the focal length) are in focus to an acceptable degree for the patient to perceive them as in focus. Multifocal IOLs, on the other hand, have at least two focal lengths. For example, a bifocal IOL has two focal lengths to improve focusing in two ranges: a distance focus corresponding to a longer focal length and a near focus corresponding to a shorter focal length. This can improve a patient's distance and near vision. Summary of the Invention [Means for solving the problem]

[0006] The multipart intraocular lens (IOL) embodiments disclosed herein are characterized in that the base may support not only a first optic that provides vision correction, but also a second optic that provides additional vision correction.

[0007] The base portion includes a continuous posterior edge and a discontinuous anterior edge, the discontinuity defining at least one recess for supporting a radial extension of the second optic.

[0008] Multipart IOLs have a unique geometry that couples a second optic to the base. Embodiments benefit patients by allowing the second optic to be added later and removed independently of the first optic. The second optic can be an electro-optic lens with autofocus for near accommodation, a toric IOL, or an additional monofocal or multifocal lens for high-power needs (e.g., greater than 30D).

[0009] Embodiments overcome the challenge of creating a stable optical unit consisting of a base and two optics that can be assembled and disassembled in the capsular bag by the surgeon. Multipart IOLs minimize cross-sectional area, allowing for smaller incisions than those required for a complete IOL. Multipart IOLs with interlocking geometries allow for easy assembly and disassembly in the capsular bag while preventing misalignment, decentration, rotation, or tilt.

[0010] Multipart IOLs with large anterior-posterior height exert circumferential forces on the capsular bag.

[0011] Furthermore, multipart IOLs with a separation distance between the two optics can reduce intralenticular opacification (ILO). Poor ILO performance can be attributed in part to any one or combination of mechanisms, including, but not limited to, IOL height, base shape, mechanical forces exerted by the leading and trailing edges, separation between the first and second optics, and increased aqueous humor flow through the base and the IOL.

[0012] For a more complete understanding of the present disclosure and its advantages, reference is now made to the following description, which should be read in conjunction with the accompanying drawings, in which like reference numerals indicate like features and in which: [Brief explanation of the drawings]

[0013] [Figure 1] FIG. 1 shows a cutaway perspective view of an IOL with a base design supporting two optics. [Figure 2] FIG. 2 shows a perspective view of a first optic supported by a base having a continuous posterior edge and a discontinuous anterior edge with a pair of recesses formed therein. [Figure 3] FIG. 3 shows a perspective view of an IOL with a base supporting a first optic and a second optic, with radial extensions disposed in recesses on the anterior edge of the base. [Figure 4]FIG. 4 shows a top view of the IOL with the straight radial extensions extending outside the base. [Figure 5] FIG. 5 shows an enlarged top view of a portion of an IOL with radial extensions formed in a dogbone shape and extending outside the base. [Figure 6] FIG. 6 shows an exploded perspective view of an IOL with a cradle formed in the base for supporting a second optic. [Figure 7] FIG. 7 shows a perspective view of a base having discontinuities at its trailing and leading edges, including a recess at its trailing edge and a recess at its leading edge. [Figure 8] FIG. 8 shows a cutaway side view of the IOL with the accommodative second optic seated on the radial extension. [Figure 9] FIG. 9 shows a cutaway side view of an IOL with the adjustable second optic seated on a structure integral with the base. DETAILED DESCRIPTION OF THE INVENTION

[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 will be used throughout the drawings to refer to the same or like parts. In the following description, relative terms such as "about," "substantially," and "approximately" are used to indicate that a variation of ±10% is possible in a numerical or other stated value, unless another variation is indicated.

[0015] Exemplary embodiments relate to ophthalmic devices, such as IOLs and contact lenses. The following description is presented to enable one skilled in the art to make and use the invention and is provided in the context of a patent application and its requirements. Various modifications to the exemplary embodiments and general principles and features described herein will be readily apparent. The exemplary embodiments are described primarily with reference to particular methods and systems provided in particular implementations. However, the methods and systems will substantially work in other implementations. Phrases such as "exemplary embodiment," "one embodiment," and "another embodiment" may refer to multiple embodiments, as well as the same or different embodiments. Embodiments will be described with reference to systems and / or devices having particular components. However, the systems and / or devices may include more or fewer components than shown, and variations in the arrangement and type of components may be made without departing from the scope of the invention. Also, exemplary embodiments will be described with reference to particular methods having particular steps. However, the methods and systems will substantially work with other methods having different and / or additional steps and steps in a different order, consistent with the exemplary embodiments. Thus, the present invention is not intended to be limited to the embodiments shown, but is to be accorded the widest scope consistent with the principles and features described herein.

[0016] I. Multipart IOLs - Overview 1 shows a cutaway perspective view of a multi-part intraocular lens (IOL) 10 including a base 12 with a first optic 14 positioned posterior to a second optic 16. As shown in FIG. 1, the first optic 14 is integrally formed with the base 12, and the second optic 16 includes one or more radial extensions 18 for coupling to the base 12, which will be described in more detail below.

[0017] As shown in FIG. 1 , the first optic 14 is formed with a thickness defined by an anterior surface 14a having a radius of curvature and a posterior surface 14b having a radius of curvature. The first optic 14 may be selected to provide base power, astigmatism correction, and / or other vision correction. The first optic 14 may be an aspheric and / or toroidal optic and may have the same or different curvatures on the anterior surface 14a and posterior surface 14b. The first optic 14 may be a single-vision optic, an extended-depth-of-focus optic, or a multifocal optic and may include other features (e.g., blue light filtering) that are not shown or described in detail for simplicity.

[0018] In the multi-part IOL 10, the second optic 16 may be removably coupled to the base 12 for piggyback insertion above, in front of, or on top of the first optic 14. The second optic 16 may provide additional base power, accommodation for near vision, or correction for other ocular conditions. One or more radial extensions 18 may prevent rotation or tilt of the second optic 16 relative to the base 12.

[0019] As can further be seen in FIG. 1, IOL 10 is configured such that posterior surface 16b of second optic 16 is separated from anterior surface 14a of first optic 14, as will be described in more detail below.

[0020] II. Base with First Optic for Use in Single Lens IOLs or Multipart IOLs 2 shows a perspective view of a base 12 having a first optic 14 for implantation in the capsular bag as a single-lens IOL 10. Base 12 includes a continuous posterior edge 20 configured to mate with first optic 14 and a discontinuous anterior edge 22.

[0021] The posterior edge 20 may be shaped to prevent lens epithelial cell (LEC) migration and / or bias the first optic 14 at the anterior or posterior regions of the lens capsule. The base 12 may also form a continuous ring on the surface of the posterior capsule of the eye during insertion, exerting a circumferential force on the lens capsule while maintaining an open configuration to reduce or prevent posterior capsular opacification (PCO). The geometry of the base 12 may also be adapted to elevate and / or separate the anterior capsule from portions of the IOL 10. For example, the shape and / or height of the anterior edge 22 around the periphery of the base 12 may be effective to support the anterior capsule or reduce the extent to which the anterior capsule may compress onto or around portions of the IOL 10. Thus, in some embodiments, both the posterior edge 20 and the anterior edge 22 may be sized and configured to separate the lens capsule from portions of the IOL 10 when the IOL 10 is inserted into the eye. One or more haptics (not shown) may be coupled to the leading edge 22 or the trailing edge 20 of the base 12 .

[0022] The leading edge 22 and the trailing edge 20 may be centered about and connected by a periphery 28 having a cross-sectional profile that may be straight or curved. In some embodiments, one or both of the leading edge 22 and the trailing edge 20 may include a portion extending along the anterior-posterior direction, which may form the periphery 28. As shown in FIG. 2 , the leading edge 22 and the trailing edge 20 may form a concave periphery 28. In other embodiments, the leading edge 22 and the trailing edge 20 may form a convex periphery 28. A base 12 formed from an elastic material and having a concave or convex periphery 28 may allow the base 12 to conform to the lens capsule and apply mechanical forces to the lens capsule for improved patient comfort, as described below.

[0023] The first optic 14 may be made of a variety of optical materials, including, but not limited to, one or more of silicone, hydrogel, acrylic, Alcon AcrySof®, and Alcon Clareon®. The first optic 14 may be formed as a symmetrical disk defined by a single radius of curvature. In some embodiments, the first optic 14 is asymmetrically formed having a first radius of curvature along a first axis and a second radius of curvature along a second axis. In other embodiments, the first optic 14 is configured for a particular ocular condition. The radius of curvature of the anterior surface 14a or posterior surface 14b may be defined across the diameter of the first optic 14 or for a diameter smaller than the diameter of the first optic 14. The base 12 may be configured with an opening 26 between the first optic 14 and the posterior edge 20 to allow aqueous humor to flow through the base 12.

[0024] In some embodiments, the base 12 coupled to the first optic 14 may be inserted through a small incision in the capsular bag so that the IOL 10 has a single optic 14 and functions as a single-lens IOL assembly. Additionally, the design of the base 12 and the ability to insert the base 12 separately from the second optic 16 may allow for minimizing the size of the incision required for implantation. The base 12 may include features (not shown) to allow access by a probe (e.g., a Sinskey hook) during surgery, thereby making the base 12 easier to manipulate.

[0025] Continuing with reference to FIG. 2 , the base 12 includes a leading edge 22 adapted to support the second optic 16. In particular, the leading edge 22 includes one or more discontinuous portions defining one or more recesses 24. The one or more recesses 24 formed in the leading edge 22 may be sized and shaped to interlock with the radial extension 18 of the second optic 16 as described herein. In some examples, the one or more recesses 24 comprise notches, depressions, or cutouts in the leading edge 22. The leading edge 22 may be the most forward feature of the base 12, and the one or more recesses 24 may define a surface posterior to the leading edge 22 such that the most forward surface of the base 12 (e.g., a front surface of the leading edge 22) is discontinuous. Furthermore, the one or more recesses 24 may be disposed in the leading edge 22 such that the outermost periphery of the most forward structure of the base 12 (e.g., the outermost periphery of the leading edge 22) is discontinuous. Thus, the discontinuity in leading edge 22 may be a deviation in the radial and / or longitudinal directions from an otherwise continuous surface or feature. In these and other examples, the discontinuity defined by one or more recesses 24 may have the same radius of curvature as leading edge 22.

[0026] III. Multipart IOLs with two optic parts FIG. 3 shows a perspective view of IOL 10 with second optic 16 removably coupled to base 12. IOL 10 may include second optic 16 to customize IOL 10 to address one or more symptoms of a particular patient. As shown in FIG. 3, second optic 16 may have an outer diameter smaller than the inner diameter of leading edge 22 such that leading edge 22 surrounds optic 16. In some instances, second optic 16 includes a diameter sufficiently smaller than the inner diameter of leading edge 22 to allow aqueous humor to flow through IOL 10 when IOL 10 is inserted into an eye and assembled. The second optic 16 of the IOL 10 further comprises one or more radial extensions 18, which may be sized and shaped to extend through, rest on, and / or seat within the recesses 24 in the leading edge 22 of the base 12 such that the radial extensions 18 of the second optic 16 rest in front of and / or contact the forward-facing surfaces of the one or more recesses 24 when the IOL 10 is assembled. The base 12 also includes an opening 26 between the first optic 14 and the trailing edge 20, and openings 30 in one or more of the leading edge 22 and the trailing edge 20, such as the peripheral surface 28, to allow aqueous humor to flow through the IOL 10. Enabling aqueous humor to flow through the IOL 10 may reduce the amount of intralenticular opacity (ILO) in the IOL 10.

[0027] IV. Multipart IOLs are configured to support different geometries of radial extensions FIG. 4 shows a top view, and FIG. 5 shows a partial top view, of an embodiment of the IOL 10 in which the second optic 16 has radial extensions 18 with different geometries. In some embodiments, each of the one or more radial extensions 18 of the optic 16 (and the one or more recesses 24 in the base 12 corresponding to the radial extensions 18) may have the same geometry and / or dimensions. In other embodiments, the radial extensions 18 of the optic 16 (and the one or more recesses 24 in the base 12 corresponding to the radial extensions 18) may have different geometries and / or dimensions such that the second optic 16 can be positioned in only one orientation relative to the base 12. In the illustrated example, each of the one or more radial extensions 18 is configured to contact the sides of or couple with one or more recesses 24 to prevent rotation, tilt, and / or decentering of the second optic 16 relative to the base 12. One or more of the radial extensions 18 may extend radially beyond the outer periphery of the base 12 when the IOL 10 is assembled (which may be defined, for example, by the outer periphery of the leading edge 22 or the trailing edge 20). Particular embodiments of the second optic 16 include two diametrically opposed radial extensions 18. Particular embodiments of the second optic 16 may include only one radial extension 18. In some embodiments, the radial extension 18 may include haptics (not shown) for stabilizing or positioning the second optic 16 or the IOL 10. In some embodiments, one or more of the radial extensions 18 may include electronic components that can provide accommodation or otherwise assist in improving the patient's vision.

[0028] 4, one or more recesses 24 in base 12 may be configured with parallel sides and a generally flat forward-facing surface, and the complementary geometry of one or more radial extensions 18 may be configured with parallel sides and a generally flat rear surface to facilitate secure placement within recess 24.

[0029] Referring to FIG. 5 , one or more recesses 24 in the base 12 may be configured with non-parallel (e.g., angled or curved) sides 32 such that the distance between each side 32 of a given recess 24 varies radially. In the example of FIG. 5 , the second optic 16 includes a radial extension 18 having a dogbone-like geometry characterized by a convex curve where each side 31 of the extension 18 is connected at a radially outermost surface 33 (which may be curved or straight). In the exemplary embodiment of FIG. 5 , the recess 24 accordingly includes a concavely curved recess 32 sized and shaped to receive and couple with the convex side of the radial extension 18. In other examples, the radial extension 18 and the recess 24 may have other complementary geometries or shapes for securing and stabilizing the second optic 16 to the base 12. In some embodiments, the radial extensions 18 may be configured such that, when assembled, the radially outermost surface 33 is generally flush with the outer periphery of the leading edge 22 of the base 12 in the radial and / or fore-aft direction. In such embodiments, one or more radial extensions 18 may not extend outwardly beyond or beyond the periphery of the base 12 in the assembled configuration. Additionally, radial extensions 18 having a dogbone shape may be disposed in other recesses 24 having other geometries.

[0030] V. Multipart IOLs with base structures for supporting various optics The base 12 is configured to support various types of second optics 16. FIG. 6 shows an exploded perspective view of one embodiment of an IOL 10 including a base 12 with a first optic 14 and a second optic 16 arranged to couple to the base 12. The leading edge 22 includes one or more recesses 24 for receiving one or more radial extensions 18 of the second optic 16. As shown in FIG. 6, embodiments of the base 12 may also include one or more cradles 34. The cradles 34 may provide additional stability and support for the second optic 16. The leading edge 22 may be formed with an anterior surface for seating the second optic 16. One or more of the leading edge 22, the recesses 24, and the anterior surface of the cradle 34 are configured to support the second optic 16, including preventing rotation, decentering, tilt, and / or misalignment of the second optic 16 relative to the first optic 14 within the base 12.

[0031] The base 12 is configured to support various types of second optics 16. The second optic 16 shown in FIG. 6 may include an electro-optic lens capable of complete (distance to near) vision correction, and one or more radial extensions 18 comprise a sealed electronics housing containing electro-active components (e.g., one or more processors, sensors, and / or a battery or other power source) adapted to control the second optic 16. For example, the second optic 16 may be an electro-optic lens capable of autofocusing to provide continuous vision accommodation from near to distance. In other examples, the second optic 16 may include a monofocal lens, an aspheric lens, a toric lens, a multifocal lens, an extended depth of focus lens, and / or other accommodating lens. The use of multiple optics allows the IOL 10 to be customized to a patient's particular ocular condition. In some cases, the modular configuration of the IOL 10 can improve vision customization. For example, the base 12 may be implanted during an initial surgery to provide a base power correction for distance vision. Subsequently (e.g., after sufficient time for healing and fixation of the lens position within the eye), a second optic 16 may be selected and implanted to correct or enhance the patient's vision. For example, if refractive correction is unsuccessful, the second optic 16 may be implanted to increase or decrease the power to correct distance vision. In other examples, the second optic 16 may be added to correct astigmatism, spherical aberration, or chromatic aberration, to provide multifocal or extended depth of focus for intermediate and / or near vision, and / or to provide accommodation for improved vision. In each case, the optical performance and characteristics of the second optic 16 are complementary to those of the first optic 14, and the actual performance of the first optic 14 in a particular patient may be considered when selecting the second optic 16. Alternatively, the IOL 10 may be initially implanted with two optics, and the second optic 16 may be removed and, if desired, replaced with a different second optic 16 in a subsequent procedure. The recess 24 may also be configured to receive a haptic (not shown).

[0032] Continuing with reference to Figure 6, the base 12 includes an anterior edge 22 joined to the posterior edge 20 at a periphery 28, and the cross-sectional profile of the anterior edge 22, posterior edge 20, and periphery 28 shown in Figure 6 is a concave structure. The base 12 may include an opening 30 at the anterior edge 22 or posterior edge 20 that allows aqueous humor to flow through the base 12 when the base 12 is inserted into the eye. The cross-sectional profile of the base 12 and opening 30 that allows aqueous humor to flow through the IOL 10 may depend on the particular type of second optic 16.

[0033] Referring now to FIG. 7 , an alternative base 12 may be formed to support the first optic 14 and an additional optic, such as the second optic 16 (not shown). Alternative designs may be necessary based on the ocular condition or the structure of the second optic 16. For example, a patient may benefit from a base 12 having a more continuous surface, or the second optic 16 may benefit from additional electronic components that increase the thickness of one or more radial extensions 18. FIG. 7 shows a perspective view of an IOL 10 in which the base 12 is formed with a discontinuous posterior edge 20 and a discontinuous anterior edge 22, with the discontinuities on the posterior edge 20 and the anterior edge 22 forming a recess 24. The base 12 shown in FIG. 7 may be formed with the first optic 14 integral with the posterior edge 20. The anterior edge 22 may have a first cross-sectional profile, and the posterior edge 20 may have a second profile. Each of the leading edge 22 and trailing edge 20 may have a concave, convex, straight, or angled cross-sectional profile.

[0034] VI. Multipart IOLs have greater height without causing patient discomfort 8 and 9, the IOL 10 may be formed with a greater height without affecting patient comfort. As shown in FIG. 8, the second optic 16 is spaced from the leading edge 22 by a gap (D Gap ) of the IOL 10 in FIG. Total ) is the thickness (T Optic-2) and the distance (D) between the second optical section 16 and the base section 12 Gap ) and the height of the base 12 (H Base ) and the second optic anterior surface 16a may be configured to reduce opacity of the IOL 10. Referring to Figure 8, the second optic anterior surface 16a may be configured to include one or more angled transition portions 36 at radial distances (R1) and (R2) and an angled edge 38 at radial distance (R3).

[0035] As can be seen in FIG. 9, in another embodiment, the rear surface 16b of the second optic 16 may be configured such that there is still some clearance (D GAP ) on a cradle 40 integral with the base 12. Also, as shown in FIG. 9, the posterior surface 14b of the first optic 14 may have a larger radius of curvature so that the first optic 14 extends a greater distance beyond the posterior surface of the posterior edge 20. In another embodiment (not shown), the second optic 16 may be seated on the anterior surface of the anterior edge 22 so that there is no gap between the second optic 16 and the anterior edge 22. Thus, the overall height (H Total ) is the thickness (T Optic-2 ) and the height of the base 12 (H Base ) and the thickness (D Optic-1 ) may be calculated based on the sum of

[0036] As can be seen from FIGS. 8 and 9, the total height of the IOL 10 is determined by the height of the base 12 (H Base ) (which may depend on the height (H A ) to the height of the trailing edge 20 (H P ) plus the thickness of one or more of the first and second optics 14 and 16, which may depend on the radius of curvature of the posterior surface 14b of the first optic 14 and the anterior surface 16a of the second optic 16, respectively. The total height of the IOL 10 may also depend on the gap (D GAP), which may depend on the depth (D R ) and the thickness of the radial extension 18 (T RE In some embodiments, the total height (H Total ) may have a height ranging from greater than 1.0 millimeters to less than 3.2 millimeters.

[0037] In some embodiments, the IOL 10 may be configured with a height-to-diameter ratio that maintains separation between the anterior and posterior capsules while avoiding irritation to the eye. The height may vary depending on the elastic modulus of the material. For example, the selected height dimensions specified in this disclosure may be based on the elastic modulus of hydrophobic and hydrophilic acrylic IOLs. Softer IOL materials, such as low-elasticity silicone, may have a greater height but do not irritate the eye. In some embodiments of the IOL 10, it may be particularly important that the height of the IOL 10 be within a certain range at the outer radial distance, i.e., the periphery, of the IOL 10. More specifically, the height of the base 12 (H Base ) is the height of the base 12 (H Base ) should be within a size range such that the anterior and posterior capsules are large enough to provide both rigidity and support to maintain separation while remaining below a certain height threshold. Heights above a certain threshold may result in undesirable forces on the anterior and posterior capsules, which may irritate the lens capsule and eye or cause other undesirable side effects.

[0038] For example, in some embodiments, at radial distances greater than about 3.5 millimeters from the center point or optical axis of the IOL 10 toward the outer periphery or circumference of the base 12, the overall height (H) of the IOL 10, as defined above, increases at some radial distances. TotalIt may be important that the height of IOL 10, which may be greater than about 1.3 millimeters, not exceed about 1.3 millimeters. In some embodiments, it may be preferred that the height of IOL 10 for radial distances greater than about 3.5 millimeters be in the range of 0.7 millimeters to 1.2 millimeters. However, in some embodiments, IOL 10 may have a total height (H ) greater than 1.3 millimeters for radial distances that are less than 3.5 millimeters from the center point, i.e., optical axis, of IOL 10, and for some radial distances, may be greater than 1.3 millimeters. Total ) may have a height that may be .

[0039] 8 and 9, the diameter (D) of the base 12 may be in the range of 7.6 mm to 8.6 mm, or in some cases in the range of 8.0 mm to 8.2 mm, which may be greater than the diameter of the second optic 16, excluding one or more radial extensions 18 of the second optic 16. Thus, in some embodiments, the height of the IOL 10 at some radial distances greater than 3.5 mm from the center point or optical axis of the IOL 10 is greater than the height (H) of the base 12. Base ) only, or in some cases the height (H Base ) to the thickness (T RE ) may be added to the height (H Base ), or the height of the base 12 (H Base ) to the thickness (T RE ) may not exceed 1.3 millimeters, or more specifically, may be in the range of 0.7 millimeters to 1.2 millimeters. Exemplary dimensions, such as height ranges and diameter ranges, may apply to other embodiments in addition to those described in connection with Figures 8 and 9.

[0040] VII. Separation of the optics to suppress ILO Also, as seen in Figures 8 and 9, embodiments of the IOL assembly 10 are configured to maintain separation between the first optic portion 14 and the second optic portion 16, which can reduce or inhibit intralens opacification (ILO).

[0041] Referring to FIG. 8, the front surface 14a of the first optical section 14 is spaced from the rear surface 16b of the second optical section 16 by a depth (D R ) and the thickness of the radial extension 18 (T RE The second optical portion 16 may be supported by a radial extension 18 seated in the recess 24 such that the second optical portion 16 is separated based on the radial extension 18 .

[0042] Referring to FIG. 9 , a trailing edge 20 may be coupled to the first optic 14, and based on the location of the first optic 14 at the trailing edge 20 and the height of the leading edge 22, the base 12 may be configured to have a height (H ) such that the front surface 14 a of the first optic 14 is separated from the rear surface 16 b of the second optic 16. Base ) . Maintaining a separation between the first optic 14 and the second optic 16 allows aqueous humor to flow through the IOL 10, which may reduce the degree of intralenticular opacification (ILO) in the IOL 10. The separation distance between the two optics may depend on the material used to fabricate the optics. For example, the separation (gap) may be important for hydrophobic acrylic IOL materials, such as AcrySof® material. Embodiments of the IOL 10 formed from hydrophobic acrylic IOL materials may be configured to separate the first optic 14 from the second optic 16 by a distance ranging from 0.25 millimeters to 0.75 millimeters. More specifically, in some embodiments, the posterior surface 16b of the second optic 16 may be separated from the anterior surface 14a of the first optic 14 by a distance ranging from 0.25 millimeters to 0.75 millimeters. The distance between the two optics may be less important if the two optics are made of different materials. For example, first optic 14 may touch second optic 16 where one optic is silicone and the other is AcrySof® material.

[0043] The separation distance between the first optical section 14 and the second optical section 16 may depend on either or both of the radius of curvature of the front surface 14a of the first optical section 14 or the radius of curvature of the rear surface 16b of the second optical section 16. A smaller radius of curvature of either the front surface 14a of the first optical section 14 or the rear surface 16b of the second optical section 16 tends to reduce the separation distance, while a larger radius of curvature of either the front surface 14a of the first optical section 14 or the rear surface 16b of the second optical section 16 tends to reduce the separation distance.

[0044] VIII. Multipart IOL Delivery / Implantation A multi-part IOL 10 comprising a base 12 with a first optic 14 and a second optic 16 may be implanted using a variety of surgical techniques. The multi-part IOL 10 may be initially implanted by delivering the base 12 in a rolled or folded configuration into the lens capsule using an injector (also known as an inserter or delivery tube) inserted through a corneal incision, through a capsulotomy, and into the lens capsule.

[0045] The base 12 may be ejected from the injector and allowed to deploy. With gentle manipulation, the haptics (not shown) of the base 12 may engage the inner equator of the lens capsule and center the base 12 in the capsulotomy. The opening 26 in the posterior edge 20 and the rim opening 30 may facilitate handling of the base 12.

[0046] In some embodiments, the first optic 14 is integral with the base 12 such that implanting the base 12 positions the first optic 14. In other embodiments, the first optic 14 is formed separately from the base 12. In these embodiments, the first optic 14 can also be delivered in a rolled or folded configuration by using an injector to position its distal tip adjacent to the base 12. The first optic 14 may be ejected from the injector and allowed to unfold. With gentle manipulation, the first optic 14 can be centered relative to the capsulotomy. The first optic 14 may have features (not shown) to facilitate insertion into the lens capsule, to remove the first optic 14 from the lens capsule, and to aid in aligning the first optic 14 relative to the base 12. When the first optic 14 is delivered to the capsular bag and deployed, the first optic 14 may be connected to the base 12 with the first optic 14 seated on the posterior edge 20 of the base 12 .

[0047] Once the first optic 14 is connected to the base 12, the second optic 16 may also be delivered in a rolled or folded configuration by using an injector to position its distal tip adjacent to the base 12. The second optic 16 may be ejected from the injector and allowed to deploy. With gentle manipulation, the second optic 16 can be centered relative to the capsulotomy. The second optic 16 may have features (not shown) to facilitate insertion into the capsular bag and to aid in aligning the second optic 16 relative to the base 12. Once the second optic 16 is delivered and deployed in the capsular bag, it may be connected to the base 12, which may include one or more of seating the posterior surface 16b of the second optic 16 on the cradle 34 on the leading edge 22 or the inner surface of the leading edge 22, and placing the radial extension 18 in the recess 24 on the leading edge 22.

[0048] If desired, the IOL 10, including the base 12, first optic 14, and second optic 16, may be removed by generally reversing the steps described above. A probe or similar device may enter the capsular bag containing the multi-part IOL 10. With gentle manipulation, the second optic 16 may be lifted so that it separates from the base 12. The probe may remove one or more of the second optic 16 and the base 12. If the first optic 14 and the base 12 are formed as separate entities, the first optic 14 may be lifted so that it separates from the base 12. The probe may remove one or more of the first optic 14 and the base 12.

[0049] A multi-part intraocular lens (IOL) has been described, comprising a base for supporting a first optic, and capable of further supporting a second optic spaced apart from the first optic. Although the device, system, and method have been described according to the exemplary embodiments shown, it will be readily apparent to those skilled in the art that variations to the embodiments may exist, and that any variations are within the spirit and scope of the above-described device, system, and method. Accordingly, many modifications may be made by those skilled in the art without departing from the spirit and scope of the appended claims. According to aspect (1), there is provided a base part, The first Faculty of Optics, The trailing edge and a leading edge defining at least one recess; a base part comprising: a second optic comprising at least one radial extension extending peripherally from an optical region of the second optic, the radial extension adapted to fit within the at least one recess to couple the second optic to the base; and A multi-part intraocular lens (IOL) comprising: According to aspect (2), the at least one radial extension is adapted to connect with the at least one recess such that the radial extension fits between the side walls of the at least one recess and rests on top of the front surface of the at least one recess. According to aspect (3), the at least one radial extension has a dog-bone geometry. According to aspect (4), the first optical section provides basic refractive power correction. According to aspect (5), the second optical section provides near vision correction. According to aspect (6), the second optical section includes one of a fixed focal length optical section, an aspheric optical section, a toric optical section, or an electro-optical section. According to aspect (7), the outer surface of the leading edge and the outer surface of the trailing edge form a concave structure. According to aspect (8), the at least one radial extension comprises an electronic component. According to aspect (9), the at least one radial extension comprises a haptic portion. According to aspect (10), the leading edge forward surface and the trailing edge aft surface define a base height of at least 0.7 millimeters over a radial distance of at least 3.5 millimeters. According to aspect (11), the height of the base is at least 1.1 millimeters over a radial distance of at least 4.1 millimeters. According to aspect (12), the first optical section has a front surface and a rear surface, the second optical section has a front surface and a rear surface; The distance between the anterior edge of the first optic and the posterior surface of the second optic is at least 0.25 millimeters. According to aspect (13), the distance between the anterior surface of the first optical portion and the posterior surface of the second optical portion is at least 0.5 millimeters. According to aspect (14), the base comprises one or more cradles, The second optic rests on the one or more pedestals. According to aspect (15), the leading edge has two or more recesses, the second optical portion comprises two or more radial extensions disposed in the two or more recesses; The second optic rests on the two or more radial extensions.

Claims

1. A base part, The first optical department; The trailing edge and a leading edge defining at least one recess; a base part comprising: a second optic comprising at least one radial extension extending peripherally from an optical region of the second optic, the radial extension adapted to fit within the at least one recess to couple the second optic to the base component; and Equipped with the base component comprises one or more cradles; A multi-part intraocular lens (IOL) in which the second optic rests on one or more of the cradles.

2. 2. The multi-part IOL of claim 1, wherein at least one of the radial extensions is adapted to couple with the at least one recess such that the radial extension fits between the side walls of the at least one recess and rests on top of the anterior surface of the at least one recess.

3. The multi-part IOL of claim 2 , wherein at least one of the radial extensions has a dog-bone geometry.

4. The multi-part IOL of claim 1 , wherein the first optic provides a base power correction.

5. The multi-part IOL of claim 4 , wherein the second optic provides near vision correction.

6. The multi-part IOL of claim 5 , wherein the second optic comprises one of a fixed focal length optic, an aspheric optic, a toric optic, or an electro-optic.

7. The multi-part IOL of claim 1 , wherein the outer surface of the leading edge and the outer surface of the trailing edge form a concave structure.

8. The multi-part IOL of claim 1 , wherein at least one of the radial extensions comprises an electronic component.

9. The multi-part IOL of claim 1 , wherein at least one of the radial extensions comprises a haptic.

10. 10. The multi-part IOL of claim 1, wherein the anterior surface of the leading edge and the posterior surface of the trailing edge define a height of the base component of at least 0.7 millimeters over a radial distance of at least 3.5 millimeters.

11. 11. The multi-part IOL of claim 10, wherein the height of the base component is at least 1.1 millimeters over a radial distance of at least 4.1 millimeters.

12. the first optical portion having a front surface and a rear surface; the second optical portion having a front surface and a rear surface; 10. The multi-part IOL of claim 1, wherein the distance between the anterior edge of the first optic and the posterior surface of the second optic is at least 0.25 millimeters.

13. 13. The multi-part IOL of claim 12, wherein the distance between the anterior surface of the first optic and the posterior surface of the second optic is at least 0.5 millimeters.

14. the leading edge comprises two or more recesses; the second optical portion comprises two or more of the radial extensions disposed in two or more of the recesses, The multi-part IOL of claim 1 , wherein the second optic rests on two or more of the radial extensions.

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