Multi-part IOL with a stable IOL base design that supports a second optical section

Abstract

An intraocular lens (IOL) configured to support a first optic for functioning as a single-lens IOL and a second optic for functioning as a dual-optic IOL. The IOL includes a base having a first optic for providing base power. A recess at the leading edge of the base is configured to locate a radial extension of the second optic. The geometry of the recess is configured to securely mate with the radial extension to prevent rotation of the second optic relative to the base and to prevent tilt of the second optic relative to the optical axis.

Description

Technical Field

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

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

Background Art

[0003] The human eye functions to provide vision by transmitting light through a transparent outer portion called the cornea and focusing an image onto the retina by 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 transparency of the lens decreases (e.g., becomes cloudy) due to age or disease, the amount of light that can be transmitted to the retina decreases, resulting in a decrease in vision. This defect of the eye's lens is medically known as a cataract. The generally accepted treatment for this condition is to surgically remove the lens from the lens capsule and insert an artificial intraocular lens (IOL) into the lens capsule. In the United States, most cataract lenses are removed by a surgical procedure called phacoemulsification. In this procedure, an opening is made in the front of the lens capsule (capsulotomy), a thin ultrasonic phacoemulsification aspiration cutting tip is inserted into the diseased lens, and vibrated ultrasonically. The vibrating cutting tip liquefies or emulsifies the lens, allowing the lens to be suctioned out of the lens capsule. The diseased lens is replaced with an IOL after removal.

[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. An object located at a distance from the eye / IOL equal to the focal length is in focus, while an object closer or farther away may be out of focus. Only an object at the focal length is completely in focus, but an object within the depth of field (within a certain distance of the focal length) is also acceptably in focus for the patient to perceive the object as being in focus. On the other hand, a multifocal IOL has at least two focal lengths. For example, a bifocal IOL has two focal lengths to improve focusing in two ranges, namely a far - distance focus corresponding to a longer focal length and a near - distance focus corresponding to a shorter focal length. This can improve the patient's far - and near - vision. SUMMARY OF THE INVENTION MEANS FOR SOLVING THE PROBLEM

[0006] Embodiments of the multi - part intraocular lens (IOL) disclosed herein are characterized in that the base can support not only a first optical portion that provides vision correction but also a second optical portion that provides additional vision correction.

[0007] The base has a continuous trailing edge and a discontinuous leading edge. The discontinuous portion defines at least one recess for supporting a radially - extending portion of the second optical portion.

[0008] The multi - part IOL has a unique geometry for connecting the second optical portion to the base. Embodiments provide benefits to the patient by allowing the second optical portion to be added later and removed independently of the first optical portion. The second optical portion can be an electro - optical lens capable of autofocusing for near - accommodation, a toric IOL, or an additional single - focal or multifocal lens for high refractive power needs (e.g., greater than 30D).

[0009] Embodiments overcome the problem of creating a stable optical unit composed of a base and two optical parts that can be assembled and disassembled in the lens capsule by a surgeon. The multi-part IOL can minimize the cross-sectional area and make the incision smaller than that required for a complete IOL. The multi-part IOL with a connecting geometry can be easily assembled and disassembled in the lens capsule while preventing misalignment, decentration, rotation, or tilt.

[0010] A multi-part IOL with a large anteroposterior height applies a circumferential force to the lens capsule.

[0011] Furthermore, a multi-part IOL having a separation distance between two optical parts can reduce intralenticular opacification (ILO). The low ILO performance may be partially due to any one or a combination of mechanisms including the height of the IOL, the shape of the base, the mechanical forces exerted by the anterior and posterior edges, the separation between the first optical part and the second optical part, and the increase in the aqueous humor flow rate through the base and the IOL.

[0012] To more fully understand 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 the drawings, like reference numerals indicate like features.

Brief Description of the Drawings

[0013]

Figure 1

Figure 2

Figure 3

Figure 4

Figure 5

Figure 6

Figure 7

Figure 8

Figure 9

DETAILED DESCRIPTION OF THE INVENTION

[0014] Here, examples of the present disclosure shown in the accompanying drawings will be described in detail. As much as possible, the same reference numerals are used throughout the drawings to refer to the same or similar components. In the following description, relative terms such as "about", "substantially", "approximately", etc. are used to indicate that a variation of ±10% is possible in a numerical value or other described value unless other variations are shown.

[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 described herein, as well as the general principles and features, will be readily apparent. Exemplary embodiments are mainly described with respect to the specific methods and systems provided in a particular implementation. However, the methods and systems will operate substantially in other implementations as well. Phrases such as "exemplary embodiment," "one embodiment," and "another embodiment" may refer to the same or different embodiments, as well as multiple embodiments. Embodiments are described with respect to systems and / or devices having specific components. However, the systems and / or devices can comprise more or fewer components than those shown, and modifications in the composition and types of components can be made without departing from the scope of the invention. Also, exemplary embodiments are described with respect to specific methods having specific steps. However, the methods and systems will operate substantially for other methods having different and / or additional steps and steps in a different order that do not conflict with the exemplary embodiments. Thus, the invention is not intended to be limited to the embodiments shown, but rather to be accorded the broadest scope consistent with the principles and features described herein and not conflicting therewith.

[0016] I. Multi-Part IOL - Overview FIG. 1 shows a cutaway perspective view of a multi-part intraocular lens (IOL) 10 comprising a base 12 in which a first optical portion 14 is disposed behind a second optical portion 16. As shown in FIG. 1, the first optical portion 14 is formed integrally with the base 12, and the second optical portion 16 comprises one or more radially extending portions 18 for coupling to the base 12, which will be described in more detail later.

[0017] As shown in FIG. 1, the first optical portion 14 is formed to have a thickness defined by a front surface 14a having a certain radius of curvature and a rear surface 14b having a certain radius of curvature. The first optical portion 14 may be selected to provide a basic refractive power, an aberration correction, and / or other vision correction. The first optical portion 14 may be an aspherical optical portion and / or a toroidal optical portion, and the front surface 14a and the rear surface 14b may have the same curvature or different curvatures. The first optical portion 14 may be a single-focus optical portion, an extended depth of focus optical portion, or a multifocal optical portion, and may include other characteristics (e.g., blue light filtering) not shown or described in detail for simplicity.

[0018] In the multi-part IOL 10, the second optical portion 16 may be removably coupled to the base 12 such that it is piggyback inserted above, in front of, or on top of the first optical portion 14. The second optical portion 16 may provide an additional basic refractive power, provide near vision accommodation, or provide correction for other eye conditions. One or more radially extending portions 18 may prevent rotation or tilting of the second optical portion 16 relative to the base 12.

[0019] As further shown in FIG. 1, the IOL 10 is configured such that the rear surface 16b of the second optical portion 16 is separated from the front surface 14a of the first optical portion 14, which will be described in more detail later.

[0020] II. Base with a First Optical Portion for Use in a Single-Lens IOL or a Multi-Part IOL FIG. 2 shows a perspective view of a base 12 having a first optical portion 14 for implantation in the crystalline lens capsule as a single-lens IOL 10. The base 12 includes a continuous rear edge 20 configured to couple with the first optical portion 14 and a discontinuous front edge 22.

[0021] The trailing edge 20 may be shaped to prevent the movement of lens epithelial cells (LECs) and / or to bias the first optical portion 14 in the anterior or posterior region 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 and apply a circumferential force to the lens capsule while maintaining the configuration in which the lens capsule is open to reduce or prevent posterior capsular opacification (PCO). The geometry of the base 12 may also be adapted to lift and / or separate the anterior capsule from the portion of the IOL 10. For example, the shape and / or height of the leading edge 22 around the periphery of the base 12 may be effective to support the anterior capsule or reduce the degree to which the anterior capsule can be compressed over or around the portion of the IOL 10. Thus, in some embodiments, both the trailing edge 20 and the leading edge 22 may be sized and configured to separate the lens capsule from the portion of the IOL 10 when the IOL 10 is inserted into the eye. One or more haptic portions (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 disposed about and connected by a peripheral surface 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 that extends along the anterior-posterior direction, and this portion may form the peripheral surface 28. As shown in FIG. 2, the leading edge 22 and the trailing edge 20 form a concave peripheral surface 28. In other embodiments, the leading edge 22 and the trailing edge 20 may form a convex peripheral surface 28. The base 12 formed of an elastic material and having a concave or convex peripheral surface 28 may enable the base 12 to conform to the lens capsule to improve the comfort of the patient and apply a mechanical force to the lens capsule, which will be described later.

[0023] The first optical portion 14 may be made of various optical materials including, but not limited to, one or more of silicone, hydrogel, acrylic, Alcon AcrySof®, and Alcon Clareon®. The first optical portion 14 may be formed as a symmetric disk defined by a single radius of curvature. In some embodiments, the first optical portion 14 is formed asymmetrically with a first radius of curvature along a first axis and a second radius of curvature along a second axis. In other embodiments, the first optical portion 14 is configured for a particular eye condition. The radius of curvature of the front surface 14a or the rear surface 14b may be defined across the diameter of the first optical portion 14, or may be defined for a diameter smaller than the diameter of the first optical portion 14. The base 12 may be provided with an opening 26 between the first optical portion 14 and the trailing edge 20 and configured such that aqueous humor can flow through the base 12.

[0024] In some embodiments, the base 12 coupled to the first optical portion 14 may be inserted through a small incision in the lens capsule such that the IOL 10 has a single optical portion 14 and functions as a single lens IOL assembly. Also, the design of the base 12 and the ability to insert the base 12 separately from the second optical portion 16 may make it possible to minimize the size of the incision required for implantation. The base 12 may be provided with features (not shown) to allow access by a probe (e.g., a Simcoe hook) during surgery, thereby allowing the base 12 to be more easily manipulated.

[0025] Continuing to refer to FIG. 2, the base 12 includes a leading edge 22 adapted to support the second optical portion 16. In particular, the leading edge 22 includes one or more discontinuous portions that define one or more recesses 24. One or more recesses 24 formed in the leading edge 22 may be sized and shaped to connect with the radial extension 18 of the second optical portion 16 as described herein. In some examples, one or more recesses 24 include notches, depressions, or cutouts in the leading edge 22. The leading edge 22 may be the foremost feature of the base 12, and one or more recesses 24 may define a surface that is behind the leading edge 22 such that the foremost surface (e.g., the front surface of the leading edge 22) of the base 12 is discontinuous. Further, one or more recesses 24 may be disposed in the leading edge 22 such that the outermost periphery (e.g., the outermost periphery of the leading edge 22) of the foremost structure of the base 12 is discontinuous. Thus, the discontinuous portion at the leading edge 22 may be a deviation from other otherwise continuous surfaces or features in the radial and / or longitudinal directions. In these and other examples, the discontinuous portion defined by one or more recesses 24 may have the same radius of curvature as the leading edge 22.

[0026] III. Multipart IOL with Two Optical Portions FIG. 3 shows a perspective view of the IOL 10 in a state where the second optical portion 16 is removably coupled to the base portion 12. The IOL 10 may include a second optical portion 16 for customizing the IOL 10 to address one or more symptoms of a particular patient. As shown in FIG. 3, the second optical portion 16 may have an outer diameter smaller than the inner diameter of the front edge 22 such that the front edge 22 surrounds the optical portion 16. In some examples, the second optical portion 16 has a diameter sized sufficiently smaller than the inner diameter of the front edge 22 such that aqueous humor can flow through the IOL 10 when the IOL 10 is inserted and assembled in the eye. The second optical portion 16 of the IOL 10 further includes one or more radially extending portions 18, and the radially extending portions 18 are sized and shaped such that when the IOL 10 is assembled, the radially extending portions 18 of the second optical portion 16 rest on and / or contact a surface in front of a surface facing in front of one or more recesses 24 and extend through the recesses 24 of the front edge 22 of the base portion 12 and rest on and / or seat therein. Also, the base portion 12 having an opening 26 between the first optical portion 14 and the rear edge 20 and one or more openings 30 in one or more of the front edge 22 and the rear edge 20 such as the circumferential surface 28 allows aqueous humor to flow through the IOL 10. The ability of aqueous humor to flow through the IOL 10 can reduce the degree of lens opacification (ILO) in the IOL 10.

[0027] IV. The multi-part IOL is configured to support different geometries of the radially extending portion FIG. 4 shows a top view of an embodiment of the IOL 10 in which the second optical portion 16 has radial extensions 18 having different geometries, and FIG. 5 shows a partial top view. In some embodiments, each of one or more radial extensions 18 of the optical portion 16 (and 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 optical portion 16 (and 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 optical portion 16 can be disposed in the base 12 in only one orientation. In the illustrated example, each of the one or more radial extensions 18 is configured to contact the side surfaces of the one or more recesses 24 or to be connected to the recesses 24 to prevent rotation, tilt, and / or eccentricity of the second optical portion 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 (which may be defined, for example, by the outer periphery of the leading edge 22 or the trailing edge 20) when the IOL 10 is assembled. A particular embodiment of the second optical portion 16 includes two radial extensions 18 that are diametrically opposed. A particular embodiment of the second optical portion 16 may include only one radial extension 18. In some embodiments, the radial extension 18 may include a haptic portion (not shown) for stabilizing or positioning the second optical portion 16 or the IOL 10. In some embodiments, one or more of the radial extensions 18 may include electronic components that can provide adjustment or otherwise assist in improving the patient's vision.

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

[0029] Referring to FIG. 5, one or more recesses 24 in the base 12 may be configured to have non-parallel (e.g., angled or curved) side surfaces 32 such that the distance between each side surface 32 of a given recess 24 varies radially. In the example of FIG. 5, the second optical portion 16 comprises a radially extending portion 18 having a dog-bone-like geometry characterized by a convex curve in which each side surface 31 of the extending portion 18 is connected by a radially outermost peripheral surface 33 (which may be curved or straight). In the exemplary embodiment of FIG. 5, the recess 24 correspondingly comprises a concave curvature 32 sized and shaped to receive and couple with the convex side surfaces of the radially extending portion 18. In other examples, the radially extending portion 18 and the recess 24 may have other complementary geometries or shapes for fixing and stabilizing the second optical portion 16 to the base 12. In some embodiments, the radially extending portion 18 may be configured such that when assembled, the radially outermost peripheral surface 33 is substantially coplanar with the outer periphery of the leading edge 22 of the base 12 in the radial and / or longitudinal directions. In such embodiments, one or more radially extending portions 18 may not extend beyond or may not extend outside the perimeter of the base 12 in the assembled configuration. Further, the radially extending portion 18 having a dog-bone shape may be disposed in other recesses 24 having other geometries.

[0030] V. Multi-part IOL having a base structure for supporting various optical portions The base 12 is configured to support various types of second optical portions 16. FIG. 6 shows an exploded perspective view of an embodiment of an IOL 10 including a base 12 with a first optical portion 14 and a second optical portion 16 arranged to be coupled 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 optical portion 16. As shown in FIG. 6, an embodiment of the base 12 may also include one or more pedestals 34. The pedestals 34 may provide additional stability and support for the second optical portion 16. The leading edge 22 may be formed with a front face for seating the second optical portion 16. One or more of the leading edge 22, the recesses 24, and the front faces of the pedestals 34 include preventing rotation, eccentricity, tilt, and / or misalignment of the second optical portion 16 relative to the first optic 14 within the base 12 and are configured to support the second optical portion 16.

[0031] The base 12 is configured to support various types of second optical units 16. The second optical unit 16 shown in FIG. 6 may include an electro-optical lens capable of complete (from far to near) vision correction. One or more radially extending portions 18 include a sealed electronic housing that houses electro-active components (e.g., one or more processors, sensors, and / or batteries or other power sources) adapted to control the second optical unit 16. For example, the second optical unit 16 may be an electro-optical lens capable of autofocusing to provide continuous vision adjustment from near to far. In other examples, the second optical unit 16 may include a single-focus lens, an aspherical lens, a toric lens, a multifocal lens, an extended depth-of-focus lens, and / or other adjustable lenses. By using multiple optical units, the IOL 10 can be customized to the specific eye condition of the patient. In some cases, the modular configuration of the IOL 10 can improve vision customization. For example, the base 12 may be implanted in a first surgery to provide basic refractive power correction for distance vision. Thereafter (e.g., after sufficient time for healing and fixation of the lens position within the eye), a second optical unit 16 may be selected and implanted to correct or enhance the patient's vision. For example, if refractive correction is unsuccessful, a second optical unit 16 may be implanted to adjust the refractive power to correct distance vision. In other examples, a second optical unit 16 may be added to correct for astigmatism, spherical aberration, or chromatic aberration, to provide multifocal or extended depth-of-focus for intermediate and / or near vision, and / or to provide adjustment for visual field improvement. In each case, the optical performance and characteristics of the second optical unit 16 are complementary to the optical performance and characteristics of the first optical unit 14, and the actual performance of the first optical unit 14 in a particular patient may be considered when selecting the second optical unit 16. Alternatively, the IOL 10 may first have two optical units implanted, and the second optical unit 16 may be removed and replaced with a different second optical unit 16 in a subsequent procedure if desired. The recess 24 may also be configured to receive a haptic portion (not shown).

[0032] Continuing to refer to FIG. 6, the base 12 has a leading edge 22 coupled to the trailing edge 20 at the outer peripheral surface 28, and the cross-sectional profiles of the leading edge 22, the trailing edge 20, and the peripheral surface 28 shown in FIG. 6 are concave structures. The base 12 may include an opening 30 at the leading edge 22 or the trailing edge 20, and the opening 30 allows aqueous humor to flow through the base 12 when the base 12 is inserted into the eye. The cross-sectional profiles of the base 12 and the opening 30 that allow aqueous humor to flow through the IOL 10 may be based on a particular type of second optical portion 16.

[0033] Next, referring to FIG. 7, an alternative base 12 may be formed to support the first optical portion 14 and additional optical portions such as a second optical portion 16 (not shown). An alternative design may be required based on the symptoms of the eye or the structure of the second optical portion 16. For example, the patient may benefit from a base 12 having a more continuous surface, and the second optical portion 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 the IOL 10, in which the base 12 is formed with a discontinuous trailing edge 20 and a discontinuous leading edge 22, and the discontinuous portions on the trailing edge 20 and the discontinuous portions on the leading edge 22 form a recess 24. The base 12 shown in FIG. 7 may be formed with a first optical portion 14 integral with the trailing edge 20. The leading edge 22 may have a first cross-sectional profile, and the trailing edge 20 may have a second profile. Each of the leading edge 22 and the trailing edge 20 may have a concave, convex, straight, or angled cross-sectional profile.

[0034] VI. The multi-part IOL has a greater height without causing discomfort to the patient Referring to FIGS. 8 and 9, the IOL 10 may be formed with a greater height without affecting the comfort of the patient. As shown in FIG. 8, the second optical portion 16 is seated on the radial extension 18 such that the second optical portion 16 is separated from the leading edge 22 by a gap (D Gap ). The overall height (H Total ) of the IOL 10 in FIG. 8 is the thickness (T Optic-2) may be calculated based on the sum of the gap (D Gap ) between the second optical part 16 and the base part 12 and the height (H Base ) of the base part 12. Referring to FIG. 8, the front surface 16a of the second optical part may be configured to reduce the turbidity of the IOL 10. The front surface 16a of the second optical part may be configured to include one or more angled transition portions 36 at the radial distances (R1) and (R2) and an angled edge 38 at the radial distance (R3).

[0035] As shown in FIG. 9, in another embodiment, the rear surface 16b of the second optical part 16 may be seated on a pedestal 40 integral with the base part 12 such that there is still some clearance (D GAP ) between the rear surface 16b of the second optical part 16 and the front edge 22. Also, as shown in FIG. 9, the rear surface 14b of the first optical part 14 may have a large radius of curvature such that the first optical part 14 extends a greater distance beyond the rear surface of the rear edge 20. In another embodiment (not shown), the second optical part 16 may be seated on the front surface of the front edge 22 such that there is no gap between the second optical part 16 and the front edge 22. Therefore, the overall height (H Total ) of the IOL 10 in FIG. 9 may be calculated based on the sum of the thickness (T Optic-2 ) of the second optical part 16, the height (H Base ) of the base part 12, and the thickness (D Optic-1 ) of the first optical part 14 extending beyond the rear edge 20.

[0036] As can be seen from FIGS. 8 and 9, the overall height of the IOL 10 may depend on the height (H Base ) of the base part 12 (which may depend on the sum of the height (H A ) of the front edge 22 and the height (H P ) of the rear edge 20). Also, the overall height of the IOL 10 may depend on the thickness of one or more of the first optical part 14 and the second optical part 16, which may in turn depend on the radii of curvature of the rear surface 14b of the first optical part 14 and the front surface 16a of the second optical part 16. The overall height of the IOL 10 may also depend on the gap (D GAP) may depend on this, which is the depth (D) of the recess 24 R ) and may depend on the thickness (T) of the radially extending portion 18 RE ). In some embodiments, the overall height (H) of the IOL 10 Total ) may be a height in the range greater than 1.0 millimeter and less than 3.2 millimeters.

[0037] In some embodiments, the IOL 10 may be configured in a ratio of height to diameter that maintains the separation between the anterior lens capsule and the posterior lens capsule while avoiding irritating the eye. The height can vary depending on the elastic modulus of the material. For example, the selected height dimensions specified in the present disclosure may be based on the elastic modulus of hydrophobic and hydrophilic acrylic IOLs. A soft IOL material such as low-elasticity silicone may have a greater height but does not irritate the eye. In some embodiments of the IOL 10, it may be particularly important that the height of the IOL 10 is within a specific range at the outer radial distance of the IOL 10, i.e., at the peripheral edge. More specifically, the height (H) of the base 12 at the outer radial distance along the IOL 10 Base ) should be within a dimensional range such that the height (H) of the base 12 Base ) is large enough to provide both rigidity and support to maintain the separation between the anterior capsule and the posterior capsule while remaining below a specific height threshold. A height exceeding the specific threshold can cause undesirable forces on the anterior capsule or the posterior capsule, and as a result, may irritate the lens capsule and the eye or cause other undesirable side effects.

[0038] For example, in some embodiments, at a radial distance greater than about 3.5 millimeters from the center point or optical axis of the IOL 10 towards the outer periphery or circumference of the base 12, at some radial distances, the overall height (H) of the IOL 10 defined above Total) It may be important that the height of the IOL10 does not exceed about 1.3 millimeters. In some embodiments, the height of the IOL10 for a radial distance greater than about 3.5 millimeters may preferably be in the range of 0.7 millimeter to 1.2 millimeters. However, in some embodiments, the IOL10 may have a height greater than 1.3 millimeters for a radial distance less than 3.5 millimeters from the center point of the IOL10, i.e., the optical axis, and may have a full height (H Total ) for some radial distances.

[0039] In some embodiments, as shown in FIGS. 8 and 9, the diameter (D) of the base 12 may be in the range of 7.6 millimeters to 8.6 millimeters, or in some cases in the range of 8.0 millimeters to 8.2 millimeters, which may be greater than the diameter of the second optical portion 16, excluding one or more radial extensions 18 of the second optical portion 16. Thus, in some embodiments, the height of the IOL10 at some radial distances greater than 3.5 millimeters from the center point or optical axis of the IOL10 is the height of the base 12 (H Base ), or in some cases may include the height of the base 12 (H Base ) plus a portion of the thickness (T RE ) of the radial extension 18. Therefore, the height of the base 12 (H Base ), or the height of the base 12 (H Base ) plus a portion of the thickness (T RE ) of the radial extension 18, shall not exceed 1.3 millimeters, or more specifically, may be in the range of 0.7 millimeter to 1.2 millimeters. Exemplary dimensions such as the height range and diameter range may be applicable to other embodiments in addition to those described in connection with FIGS. 8 and 9.

[0040] VII. Separation of the Optical Portion to Suppress ILO Also, as can be seen in FIGS. 8 and 9, embodiments of the IOL assembly 10 are configured to maintain a separation between the first optical portion 14 and the second optical portion 16, whereby in-lens opacification (ILO) can be reduced or suppressed.

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

[0042] Referring to FIG. 9, the trailing edge 20 may be coupled to the first optical portion 14, and the base 12 may have a height (H Base ) such that the front surface 14a of the first optical portion 14 is separated from the rear surface 16b of the second optical portion 16 based on the position of the first optical portion 14 at the trailing edge 20 and the height of the leading edge 22. By maintaining the separation between the first optical portion 14 and the second optical portion 16, aqueous humor can flow through the IOL 10, whereby the degree of in-lens opacification (ILO) in the IOL 10 can be reduced. The separation distance between the two optical portions may depend on the materials used to manufacture the optical portions. For example, in the case of a hydrophobic acrylic IOL material such as AcrySof® material, the separation (gap) can be important. Embodiments of the IOL 10 formed of a hydrophobic acrylic IOL material may be configured to separate the first optical portion 14 from the second optical portion 16 by a distance in the range of 0.25 millimeters to 0.75 millimeters. More specifically, in some embodiments, the rear surface 16b of the second optical portion 16 may be separated from the front surface 14a of the first optical portion 14 by a distance in the range of 0.25 millimeters to 0.75 millimeters. The distance between the two optical portions may not be as critical if the materials of the two optical portions are different. For example, if one optical portion is silicone and the other is AcrySof® material, the first optical portion 14 may touch the second optical portion 16.

[0043] The separation distance between the first optical portion 14 and the second optical portion 16 may depend on either or both of the radius of curvature of the front surface 14a of the first optical portion 14 or the radius of curvature of the rear surface 16b of the second optical portion 16. When either the front surface 14a of the first optical portion 14 or the rear surface 16b of the second optical portion 16 has a small radius of curvature, the separation distance tends to be small, and when either the front surface 14a of the first optical portion 14 or the rear surface 16b of the second optical portion 16 has a large radius of curvature, the separation distance tends to be large.

[0044] VIII. Delivery / Implantation of Multipart IOL The multipart IOL 10 including the base 12 having the first optical portion 14 and the second optical portion 16 may be implanted using various surgical techniques. The multipart IOL 10 may be first implanted by delivering the base 12 in a rolled or folded configuration into the capsular bag through a corneal incision, through a capsulotomy, using an injector (also known as an inserter or delivery tube) inserted into the capsular bag.

[0045] The base 12 may be ejected from the injector and deployed. By gently manipulating, the haptic portion (not shown) of the base 12 may engage with the inner equator of the capsular bag, and the base 12 may be positioned at the center of the capsulotomy. The opening 26 of the rear edge 20 and the rim opening 30 may facilitate the handling of the base 12.

[0046] In some embodiments, the first optical portion 14 is integral with the base 12 such that the first optical portion 14 is positioned by implanting the base 12. In other embodiments, the first optical portion 14 is formed separately from the base 12. In these embodiments, the first optical portion 14 can also be delivered in a rounded or folded configuration by using an injector to position its distal tip adjacent to the base 12. The first optical portion 14 can be emitted from the injector and be deployable. By gentle manipulation, the first optical portion 14 can be centered with respect to the capsulotomy. The first optical portion 14 may have features (not shown) to facilitate insertion into the lens capsule, to remove the first optical portion 14 from the lens capsule, and to assist in aligning the first optical portion 14 with respect to the base 12. When the first optical portion 14 is delivered and deployed into the lens capsule, the first optical portion 14 may be seated on the trailing edge 20 of the base 12 and connected to the base 12.

[0047] Once the first optical portion 14 is connected to the base 12, the second optical portion 16 can also be delivered in a rounded or folded configuration by using an injector to position its distal tip adjacent to the base 12. The second optical portion 16 can be emitted from the injector and be deployable. By gentle manipulation, the second optical portion 16 can be centered with respect to the capsulotomy. The second optical portion 16 may have features (not shown) to facilitate insertion into the lens capsule and to assist in aligning the second optical portion 16 with respect to the base 12. When the second optical portion 16 is delivered and deployed into the lens capsule, the second optical portion 16 may be connected to the base 12, which may include one or more of seating the rear face 16b of the second optical portion 16 on the receiving platform 34 on the leading edge 22 or on the inner surface of the leading edge 22 and disposing the radial extension 18 in the recess 24 on the leading edge 22.

[0048] Optionally, the IOL 10 comprising the base 12, the first optical portion 14, and the second optical portion 16 may be removed by generally reversing the steps described above. A probe or similar device may enter the capsular bag housing the multi-part IOL 10. By gently manipulating, the second optical portion 16 may be lifted so that the second optical portion 16 and the base 12 are separated. The probe may remove one or more of the second optical portion 16 and the base 12. When the first optical portion 14 and the base 12 are formed separately, the first optical portion 14 may be lifted so that the first optical portion 14 and the base 12 are separated. The probe may remove one or more of the first optical portion 14 and the base 12.

[0049] A multi-part intraocular lens (IOL) has been described that includes a base for supporting a first optical portion and is further capable of supporting a second optical portion spaced apart from the first optical portion. Although the apparatus, system, and method have been described in accordance with the illustrated exemplary embodiments, it should 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 apparatus, system, and method described above. 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), a base component comprising: a first optical portion; a trailing edge; and a leading edge defining at least one recess and a base component; a second optical portion comprising at least one radially extending portion extending from an optical region of the second optical portion to a periphery, the radially extending portion being adapted to fit within the at least one recess for coupling the second optical portion to the base, and a second optical portion; A multi-part intraocular lens (IOL) comprising: According to aspect (2), the at least one radially extending portion is adapted to connect to the at least one recess such that the radially extending portion fits between side walls of the at least one recess and rests on an upper portion of a front surface of the at least one recess. According to aspect (3), the at least one radially extending portion has a dog-bone shaped geometry. According to aspect (4), the first optical portion provides basic refractive power correction. According to aspect (5), the second optical portion provides near vision correction. According to aspect (6), the second optical portion includes one of a fixed focal length optical portion, an aspherical optical portion, a toric optical portion, or an electro-optical portion. According to aspect (7), an outer surface of the leading edge and an outer surface of the trailing edge form a concave structure. According to aspect (8), the at least one radially extending portion comprises an electronic component. According to aspect (9), the at least one radially extending portion comprises a haptic portion. According to aspect (10), a front surface of the leading edge and a rear surface of the trailing edge define a base height of at least 0.7 millimeters at a radial distance of at least 3.5 millimeters. According to aspect (11), the base height is at least 1.1 millimeters at a radial distance of at least 4.1 millimeters. According to aspect (12), the first optical portion comprises a front surface and a rear surface, the second optical portion comprises a front surface and a rear surface, a distance between the leading edge of the first optical portion and the rear surface of the second optical portion is at least 0.25 millimeters. According to aspect (13), the distance between the front surface of the first optical portion and the rear surface of the second optical portion is at least 0.5 millimeters. According to aspect (14), the base comprises one or more pedestals, The second optical part is seated on the one or more receiving platforms. According to aspect (15), the front edge includes two or more recesses, the second optical part includes two or more radially extending parts arranged in the two or more recesses, and the second optical part is seated on the two or more radially extending parts.

Claims

**Claim 1** A base component comprising: a first optical portion; a trailing edge; a leading edge defining at least one recess; the base component; a second optical portion comprising at least one radially extending portion extending from an optical region of the second optical portion to a periphery, the radially extending portion being adapted to fit within the at least one recess for coupling the second optical portion to the base component; comprising; the base component comprising one or more receptacles; the second optical portion being seated on the one or more receptacles, a multi-part intraocular lens (IOL). **Claim 2** The multi-part IOL according to claim 1, wherein at least one of the radially extending portions is adapted to connect with the at least one recess such that the radially extending portion fits between side walls of the at least one recess and rests on an upper portion of a front surface of the at least one recess. **Claim 3** The multi-part IOL according to claim 2, wherein at least one of the radially extending portions has a dog-bone shaped geometry. **Claim 4** The multi-part IOL according to claim 1, wherein the first optical portion provides basic refractive power correction. **Claim 5** The multi-part IOL according to claim 4, wherein the second optical portion provides near vision correction. **Claim 6** The multi-part IOL according to claim 5, wherein the second optical portion includes one of a fixed focal length optical portion, an aspherical optical portion, a toric optical portion, or an electro-optical portion. **Claim 7** The multi-part IOL according to claim 1, wherein an outer surface of the leading edge and an outer surface of the trailing edge form a concave structure. **Claim 8** The multi-part IOL according to claim 1, wherein at least one of the radially extending portions comprises an electronic component. **Claim 9** The multi-part IOL according to claim 1, wherein at least one of the radially extending portions comprises a haptic portion. **Claim 10** The multi-part IOL according to claim 1, wherein a front surface of the leading edge and a rear surface of the trailing edge define a height of the base component of at least 0.7 millimeters at a radial distance of at least 3.5 millimeters. **Claim 11** The multi-part IOL according to claim 10, wherein the height of the base component is at least 1.1 millimeters at a radial distance of at least 4.1 millimeters. **Claim 12** The first optical portion comprising a front surface and a rear surface; The second optical portion comprising a front surface and a rear surface; The multi-part IOL according to claim 1, wherein the distance between the leading edge of the first optical part and the rear surface of the second optical part is at least 0.25 millimeters.

13. The multi-part IOL according to claim 12, wherein the distance between the front surface of the first optical part and the rear surface of the second optical part is at least 0.5 millimeters.

14. The leading edge includes two or more recesses, the second optical part includes two or more radially extending portions disposed in the two or more recesses, The multi-part IOL according to claim 1, wherein the second optical part sits on the two or more radially extending portions.

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