Device configured for intraocular insertion

JP2024180488A5Pending Publication Date: 2025-04-25CLARVISTA MEDICAL INC +1
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Patent Information

Application Number
JP2024177409
Authority / Receiving Office
JP · JP
Patent Type
Applications
Current Assignee / Owner
Priority Date
2015-08-17
Filing Date
2024-10-09
Publication Date
2025-04-25

AI Technical Summary

Technical Problem

Existing intraocular lens (IOL) implantation methods face challenges in correcting or modifying optical outcomes without manipulating the lens capsule, which can risk damaging the capsular bag and increase complications over time.

Method used

A modular IOL system comprising an intraocular base and optical components that allow for adjustment or replacement of the lens while the base remains in place, utilizing an annular base with radially extending haptics and interchangeable tabs for secure attachment, and an injector device for serial or parallel loading of modular IOLs.

Benefits of technology

Enables correction or modification of optical results without removing the IOL, reducing the risk of capsular damage and providing flexibility for refractive adjustments post-surgery, including the ability to upgrade or downgrade lens types as needed.

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Abstract

To enable the correction or adjustment of optical results without the need to manipulate the lens capsule.SOLUTION: A device configured for intraocular insertion is disclosed. The device comprises an annular base and a lens. The lens comprises an optical portion, a first tab protruding from the optical portion, and a second tab protruding from the optical portion so as to face the first tab in a radial direction. The second tab comprises a pair of cantilevered springs with one end attached to the optical portion and the other end being a free end. The second tab is deformable between a radially compressed position and an uncompressed extended position in order to interlockingly connect the lens and the annular base.SELECTED DRAWING: Figure 7A
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Description

[Technical field]

[0001] The present invention relates to devices configured for insertion into the eye, i.e., intraocular lenses (IOLs). More particularly, the present invention relates to modular IOL designs, methods and associated instrumentation embodiments. [Background technology]

[0002] 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.

[0003] When the lens becomes less transparent (e.g., clouded) due to age or disease, vision decreases because less light can pass through to the retina. This defect in the eye's lens is medically known as a cataract. The accepted treatment for this condition is the surgical removal of the lens from the capsular bag and the placement of an artificial intraocular lens (IOL) within the bag. In the United States, the majority of cataractous lenses are removed by a surgical procedure called phacoemulsification. During this procedure, an opening (capsulorhexis) is made in the anterior side of the capsular bag and a thin phacoemulsification cutting tip is inserted into the diseased lens to produce ultrasonic vibrations. The vibrating cutting tip liquefies or opacifies the lens so that it can be aspirated from the capsular bag. The diseased lens is removed and replaced with an IOL.

[0004] Following cataract surgery to implant an IOL, the optical outcome may be poor or may require adjustment over time. For example, shortly after the procedure, it may be determined that the refractive correction is incorrect, resulting in what is sometimes called a "reflective surprise." It may also be determined, for example, long after the procedure that the patient needs or desires a different correction, such as a stronger refractive correction, an astigmatism correction, or a multifocal correction.

[0005] In each of these cases, the surgeon may be reluctant to attempt to remove the poor IOL from the capsule and replace it with a new IOL. Generally, manipulation of the capsule to remove the IOL carries the risk of inflicting damage to the capsule, including posterior rupture. This risk increases over time as the capsule collapses around the IOL and tissue ingrowth wraps around the haptics of the IOL. It is therefore desirable to be able to correct or modify the optical outcome without having to remove the IOL or manipulate the capsule.

[0006] Thus, there is a need for an IOL system and method that allows for correction or modification of the optical result by using a lens that can be attached to a base or primary lens, without the need to manipulate the capsular bag. Summary of the Invention

[0007] Aspects of the invention provide modular IOL systems that include an intraocular base and an optical component that, when assembled, form a modular IOL that generally allows the lens to be adjusted or replaced while the base remains in place, either intraoperatively or postoperatively.

[0008] In one embodiment, the modular IOL system includes an annular base having two haptics extending radially outward. The base defines a central hole and an inner periphery and has a recess open radially inward at the inner periphery. The modular IOL system also includes a lens having an optical body with first and second tabs extending radially outward. The base and the lens may be assembled by placing the first and second tabs of the lens in the recesses of the base. The first tab may be a variable spring and the second tab may be a non-variable extension. The first tab requires radial compression for assembly of the lens with the base. The first tab may comprise a pair of cantilever springs, each with one end attached to the optical body and the other end free.

[0009] The drug injection and / or sensor functions can be located in the base, which offers several advantages over locating such functions in the lens, such as avoiding interference that would occur if the drug or sensor had the optical properties of the lens.

[0010] Aspects of the invention also provide an injector device that facilitates the in-line or parallel loading of the base and lens of a modular IOL. The injector may include a barrel having at least one internal lumen with at least one plunger disposed therein. After both the base and lens are loaded into the barrel, the distal end of the barrel is placed into the eye and the plunger is advanced within the barrel to place the base and lens into the eye. The base and lens may be placed into the eye sequentially or simultaneously. The barrel may include, for example, a single internal lumen with a single plunger disposed therein, may include parallel internal lumens with a plunger disposed in each lumen and meeting distally, or may include a single internal lumen with a pair of coaxial plungers disposed therein. The base and lens may be disposed in-line within the barrel or, if desired, may be disposed in parallel using a cartridge.

[0011] Modular IOL systems, devices, and methods according to the present invention are applicable to a variety of IOL types, including fixed monofocal, multifocal, toric, accommodative, and combinations thereof. In addition, modular IOL systems, devices, and methods according to aspects of the present invention can be used to treat large optical errors, ectopia lentis, aphakia, pseudophakia, and nuclear sclerosis, for example, in cataract, myopic (near-sighted), hyperopic (far-sighted), and astigmatic eyes.

[0012] Various other aspects of embodiments of the invention are described in the following detailed description and in the drawings. The drawings illustrate example embodiments of the present invention. The drawings are not necessarily to scale, may include similar elements numbered identically, and may include, by way of example, but not necessarily by way of limitation, dimensions (in millimeters) and angles (in degrees). [Brief description of the drawings]

[0013] [Figure 1] Schematic diagram of the human eye shown in cross section. [Figure 2A] 1 is a diagram of a modular IOL placed within a capsular bag in accordance with an embodiment of the present invention. [Figure 2B] 1 is a diagram of a modular IOL placed within a capsular bag in accordance with an embodiment of the present invention. [Figure 2C] 1 is a diagram of a modular IOL placed within a capsular bag in accordance with an embodiment of the present invention. [Figure 2D] 1 is a diagram of a modular IOL placed within a capsular bag in accordance with an embodiment of the present invention. [Figure 2E] 1 is a diagram of a modular IOL placed within a capsular bag in accordance with an embodiment of the present invention. [Figure 2F] 1 is a diagram of a modular IOL placed within a capsular bag in accordance with an embodiment of the present invention. [Figure 3A] 2A-2C are diagrams of alternative base portions of modular IOLs according to embodiments of the present invention. [Figure 3B] 2A-2C are diagrams of alternative base portions of modular IOLs according to embodiments of the present invention. [Figure 3C] 2A-2C are diagrams of alternative base portions of modular IOLs according to embodiments of the present invention. [Figure 3D] 2A-2C are diagrams of alternative base portions of modular IOLs according to embodiments of the present invention. [Figure 3E] 2A-2C are diagrams of alternative base portions of modular IOLs according to embodiments of the present invention. [Figure 3F] 2A-2C are diagrams of alternative base portions of modular IOLs according to embodiments of the present invention. [Figure 4A] 1A-1D show examples of methods for implanting and removing a modular IOL. [Figure 4B] 1A-1D show examples of methods for implanting and removing a modular IOL. [Figure 4C] 1A-1D show examples of methods for implanting and removing a modular IOL. [Figure 4D] 1A-1D show examples of methods for implanting and removing a modular IOL. [Figure 4E] 1A-1D show examples of methods for implanting and removing a modular IOL. [Figure 4F] 1A-1D show examples of methods for implanting and removing a modular IOL. [Figure 4G] 1A-1D show examples of methods for implanting and removing a modular IOL. [Figure 5A] 1 is a schematic side view of an in-line device for implanting a modular IOL. [Figure 5B] 1 is a schematic side view of a parallel device for implanting a modular IOL. [Figure 5C] 1 is a schematic side view of an in-line device for implanting a modular IOL. [Figure 5D] 1 is a schematic side view of a parallel device for implanting a modular IOL. [Figure 6A] 1 illustrates an alternative base portion of a modular IOL according to the present invention. [Figure 6B] 1 illustrates an alternative base portion of a modular IOL according to the present invention. [Figure 6C] 1 illustrates an alternative base portion of a modular IOL according to the present invention. [Figure 7A] FIG. 2 is a perspective view of an alternative lens portion of a modular IOL according to the present invention. [Figure 7B] FIG. 2 is a plan view of an alternative lens portion of a modular IOL according to the present invention. [Figure 7C] FIG. 2 is a plan view of an alternative lens portion of a modular IOL according to the present invention. [Figure 8A] 1 is a perspective view of another alternative lens portion of a modular IOL according to the present invention. [Figure 8B] FIG. 2 is a plan view of another alternative lens portion of a modular IOL according to the present invention. [Figure 9] FIG. 2 is a plan view of an alternative lens portion of a modular IOL with drug injection capability according to the present invention. [Figure 10] FIG. 2 is a plan view of an alternative lens portion of a modular IOL with sensor functionality according to the present invention. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0014] Referring to FIG. 1, a human eye 10 is shown in cross-section. The eye 10 is referred to as a light-responsive organ for several purposes. As a conscious sensory organ, the eye enables vision. The rod and cone cells of the retina 24 enable conscious light perception and vision, including color discrimination and depth perception. In addition, the non-image-forming photosensitive ganglion cells of the human eye within the retina 24 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.

[0015] The eye 10 is not exactly a sphere, but rather a fused two-part unit. A smaller, more curved anterior unit called the cornea 12 is connected to a larger unit called the sclera 14. The corneal portion 12 typically has a radius of about 8 mm (0.3 in). The sclera 14 makes up the remaining 5 / 6 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, one sees the iris 16, i.e., the color of the eye, and its black center, the pupil. To see inside the eye 10, an ophthalmoscope is required, as light is not reflected. The fundus (area opposite the pupil), including the macula 28, shows the characteristic pale optic disc (papilla), where the blood vessels entering the eye pass and where the optic nerve fibers 18 exit the eye.

[0016] Thus, the eye 10 is made up of three coatings that encase three transparent structures. The outermost layer is made up of the cornea 12 and the sclera 14. The middle layer is made up of the choroid 20, the ciliary body 22, and the iris 16. The innermost layer is the retina 24, which receives its circulation not only from the blood vessels of the retina, which can be seen in an ophthalmoscope, but also from the blood vessels of the choroid 20. Within these coatings are aqueous humor, vitreous body 26, and a flexible crystalline lens 30. Aqueous humor is a transparent fluid contained in two regions: the anterior chamber, between the cornea 12 and the exposed areas of the iris 16 and crystalline lens 30, and the posterior chamber, between the iris 16 and crystalline lens 30. The crystalline lens 30 is suspended to the ciliary body 22 by the ciliary zonules 32 (zonules of Zinn), which are made up of minute transparent fibers. The vitreous body 26 is a transparent, jelly-like substance that is much larger than the aqueous humor.

[0017] The crystalline lens 30 is a transparent, biconvex structure within the eye that, together with the cornea 12, helps refract light so that it is imaged onto the retina 24. By changing its shape, the crystalline lens 30 functions to change the focal length of the eye to focus on objects at various distances, thereby allowing a sharp, real image of the object of interest to be formed on the retina 24. This adjustment of the crystalline lens 30 is known as accommodation, and is similar to a photographic camera changing focus by moving its lens.

[0018] The lens has three main parts: the lens capsule, the lens epithelium, and the lens fibers. The lens capsule forms the outermost layer of the lens, and the lens fibers form most of the interior of the lens. The cells of the lens epithelium, located between the lens capsule and the outermost layer of lens fibers, are found primarily on the anterior side of the lens, but also extend posteriorly a little past the equator.

[0019] 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 epithelium and its main components are type IV collagen and sulfated glycosaminoglycans (GAGs). It is very elastic and allows the lens to assume a more spherical shape in the absence of tension from the zonular fibers that connect it to the ciliary body 22. The capsule varies in thickness between approximately 2 and 28 micrometers, being thickest near the equator and thinnest near the posterior pole. The capsule may be involved in a higher anterior curvature of the lens than posteriorly.

[0020] Various diseases and disorders of the crystalline lens 30 may be treated with an IOL. By way of example, and not necessarily by way of limitation, a modular IOL system according to embodiments of the present invention may be used to treat cataracts, myopia (near-sightedness), hyperopia (far-sightedness), as well as large optical errors in astigmatic eyes, ectopia lentis, aphakia, pseudophakia, and nuclear sclerosis. For purposes of illustration, however, modular IOL embodiments of the present invention will be described with respect to cataracts.

[0021] The following detailed description describes various embodiments of a modular IOL system with an intraocular base configured to releasably receive a primary intraocular element and a secondary intraocular element, i.e., an intraocular optic. More broadly, features described with respect to any one embodiment may be applied to and incorporated into other embodiments.

[0022] 2A-2F, an embodiment of a modular IOL 90 including a base 55 and a lens 65 is shown in schematic form. FIGS. 2A-2C show the base 55 of the modular IOL 90, and FIGS. 2D-2F show the optical portion, i.e., the lens portion 65, of the modular IOL 90. Specifically, FIG. 2A shows a front view of the base 55, FIG. 2B shows a cross-sectional view along the arrow BB in FIG. 2A, and FIG. 2C shows a perspective view of the base 55. FIG. 2D shows a front view of the lens 65, FIG. 2E shows a cross-sectional view along the arrow EE in FIG. 2D, and FIG. 2F shows a perspective view of the lens 65. The modular IOL 90 may have dimensions as shown in the drawings by way of example, and are not necessarily limited to these.

[0023] 2A-2C, a portion of the base 55 of the modular IOL 90 includes a pair of haptics 54 and a central hole 57 such that when the lens 65 is attached to the base 55, the posterior optical surface of the lens 65 does not contact the base 55 except at its outermost portion. A recessed groove 92 is sized and configured to receive tab portions 95, 96 of the lens 65 and defines a periphery of the hole 57.

[0024] The recessed groove 92 includes a lower rim 91 and an upper rim 93 and an inwardly facing sidewall 94. The upper rim 93 has an inner diameter that is equal to or greater than the outer diameter of the optical portion 97 of the lens 65 (excluding tab portions 95 and 96) so that the lens 65 can remain inside the hole 57 of the base 55. All or a portion of the lower rim 91 has an inner diameter that is smaller than the outer diameter of the lens 65 (including tab portions 95 and 96) so that the lower rim 91 acts as a ledge or backstop for the lens 65 when placed within the hole 57 of the base 55. By way of example, and not necessarily by way of limitation, upper rim 93 has an inner diameter of approximately 6.0 mm, lower rim 91 has an inner diameter of approximately 5.5 mm, optical portion 97 of lens 65 has an outer diameter of approximately 5.8 mm, and tabs 95, 96 have a diameter or dimension from the top of tab 95 to the top of tab 96 of approximately 7.125 mm.

[0025] The lower rim 91 and upper rim 93 defining the groove 92 may extend continuously around all or part of the circumference of the hole 57. The base 55 may be cold machined in two pieces including a lower or rear portion 55-1 and an upper or front portion 55-2 that are subsequently joined (e.g., adhesively or solvent bonded) and may be well suited to define the continuous groove 92. To maintain compatibility of chemical and mechanical properties, the adhesive and the parts 55-1 and 55-2 of the base 55 may comprise the same monomer or polymer formulation. For example, the adhesive may be formulated from the same acrylic monomers used to manufacture the hydrophobic acrylic parts 55-1 and 55-2 of the base 55. Alternatively, the lower rim 91 and upper rim 93 defining the groove 92 may extend discontinuously around all or part of the circumference of the hole 57. An example of an intermittent configuration is suitable for cryogenically machining the base 55 in a single piece, alternating lower rims 91 and upper rims 93. Other manufacturing methods well known in the art may also be used.

[0026] Optionally, the posterior portion 55-1 of the base, rather than being an annular ring with holes 57, may be a solid disk defining a posterior surface against which the posterior side of the lens 65 contacts. The posterior surface may be flat or may be curved to match the posterior contour of the lens 65. This has the advantage of providing a backstop for the lens 65, making it easier to load and position the lens 65 relative to the base 55. This also provides the advantage of reducing the rate of posterior capsule opacification.

[0027] 2D-2F, the lens 65 of the modular IOL 90 includes an optic portion 97 and one or more tabs 95, 96. As shown, tab 95 is stationary while tab 96 is variable. Alternatively, the stationary tab 95 may be replaced with a variable tab (such as tab 96). The stationary tab 95 may include a through hole 98 that may be engaged by a probe or similar device to manipulate the tab 95. The variable tab 96 is variable between a compressed position for insertion into the hole 57 of the base 55 and a non-compressed expanded position (as shown) for deployment within the groove 92 of the base 55, thereby forming an interlocking connection between the base 55 and the lens 65.

[0028] The outer curvature of the stationary tab 95 may have a radius that matches the inner radius of the groove 92. Similarly, the outer curvature of the variable tab 96 may have a radius that matches the inner radius of the groove 92 when the variable tab 96 is in its uncompressed, expanded position. This configuration limits relative motion between the base 55 and the lens 65 once joined.

[0029] Optionally, the lens 65 may be oval or elliptical rather than circular, with the tabs 95, 96 positioned proximate the major axis, such that the configuration defines a gap between the edge of the lens 65 along its minor axis and the inner circumference of the upper rim 93 of the groove 92 in the base 55. The gap may have the advantage of providing access for a probe or similar device to remove the lens 65 from the base 55, should disassembly become necessary.

[0030] Variable tab 96 is shown with two ends attached to lens 65 and extending away from the lens, with a middle portion moving away from lens 65 (like a leaf spring). Alternatively, variable tab 96 may have one end attached to lens 65 and extending away from the lens, and the other end free (like a cantilever spring). Other spring configurations may be used as known in the mechanical arts.

[0031] The variable tab 96 is resiliently deformable (e.g., under the action of a lateral inward force) into its compressed position. To facilitate compression with small forces, dimples 99 may be provided on the outer curved surface of the outer (and / or inner) side of the tab to make the hinge springy.

[0032] 3A-3F show another base 55A of a modular IOL 90. Specifically, FIG. 3A shows a front view of the base 55, FIG. 3B shows a cross-sectional view along the line BB in FIG. 3A, FIG. 3C shows a perspective view of the base 55A, FIG. 3D shows a detailed view of circle D in FIG. 3B, FIG. 3E shows a detailed view of circle E in FIG. 3A, and FIG. 3F shows a perspective view of the assembled modular IOL 90 including the base 55A and the lens 65. In this alternative embodiment, all aspects of the base 55A of the modular IOL 90 are substantially identical except that it includes a pair of notches 91A, a pair of notches 93A, an outwardly facing rim 53, and sharp edges 91B, 91C. All similar aspects of the previous embodiment are applicable to this embodiment. Dimensions are also provided for illustrative purposes and are not limiting.

[0033] As in the previous embodiment, the base 55A portion of the modular IOL 90 of this alternative embodiment includes a pair of haptics 54 and a central hole 57 such that when the lens 65 is attached to the base 55, the posterior optical surface of the lens 65 does not contact the base 55 except at the outermost portion. Also, as in the previous embodiment, the base 55A may be formed as a unitary piece or may be formed with a posterior portion 55A-1 and an anterior portion 55A-2 bonded together (as shown) or otherwise secured to one another. A recess 92 sized and configured to receive tab portions 95, 96 of the lens 65 defines the hole 57. The recess 92 includes a lower rim 91, an upper rim 93, and an inwardly facing sidewall 94. The lower rim 91 may be part of the posterior portion 55A-1 of the base 55A, and the upper rim 91 may be part of the anterior portion 55A-2 of the base 55A.

[0034] In this alternative embodiment of the base 55A of the modular IOL 90, the lower rim 91 may include one or more notches 91A to aid in the removal of visco-elastic during surgery, and in this alternative embodiment, the upper rim 93 may include one or more notches 293A to provide access to the Sinskey hooks that allow the base 55 to be more easily manipulated during surgery.

[0035] Additionally, in this embodiment, the base 55A may include an outer rim 53 that extends substantially around the entire periphery of the base 55A. The outer rim 53 may be formed as part of the rear portion 55A-1 of the base 55A, as shown, or may be formed as part of the front portion 55A-2 of the base. The outer rim 53 may be flexibly joined to the body of the haptic 54, terminating the joint of the haptic 54 below the inner curvature of the haptic 54, and the base 55A and outer rim 53 may extend continuously with respect to the outer curvature of the haptic 54.

[0036] The rearmost portion of the base 55A may include at least one corner edge 91B along the periphery of the base 55A to reduce the tendency for posterior capsule opacification, and the periphery of the base 55A may include corner edges 91C and 91D. In addition, an anterior corner edge 93B is formed along the anterior periphery of the base 55A. The corner edges 91B, 91C, and 91D may be formed on the posterior portion 55A-1 of the base 55A that defines the lower rim 91, and the corner edge 93B may be formed on the anterior portion 55A-2 of the base 55A that defines the upper rim 93. In cross section, the corner edges 91B, 91C, 91D, and 93B may be defined as right angles, acute angles, or obtuse angles. The posterior corner edge 91B may be flush with the posterior surface as shown, or may project posteriorly. The base 55A can be machined without a subsequent inversion step to better define the corner edges 91B, 91C, 91D, 93B. Preferably, the corner edges 91B, 91C, 91D, 93B may extend around the entire periphery of the base 55A.

[0037] 2B, 3B, and 2E, it should be noted that the lower rim 91 and the upper rim 93 may define an anterior-posterior (AP) dimension around the periphery of the base 55 / 55A that is greater than a corresponding AP dimension of the lens 65 proximate the tabs 95, 96 that fit into the grooves 92. For example, as shown in FIGS. 2B and 3B, the AP dimension around the periphery of the base 55 / 55A may be 0.615 mm, while the corresponding AP dimension of the lens 65 proximate the tabs 95, 96 may be 0.25 mm, as shown in FIG. 2E. When the modular IOL 90 is implanted within the capsular bag, these relative dimensions provide a standoff between the posterior capsule and the posterior side of the lens 65, as well as a standoff between the anterior capsule (sometimes called the anterior apex) proximate the capsulotomy and the anterior side of the optic. This separation reduces the possibility of cellular proliferation that may otherwise prevent replacement of the optic post-operatively, as well as opacification of the lens 65 and / or tissue attachment to the lens 65. Since such cellular proliferation typically grows radially inward, the separation is provided proximate the periphery of the lens 65 proximate the inner circumference of the lower and upper rims 91, 93, while the center of the optic may or may not have a separation and has an AP dimension that is smaller, the same as, or larger than the AP dimension around the circumference of the base 55 / 55A.

[0038] For example, the central portion of the optic may have an AP dimension of 0.78 mm (depending on diopter) as shown in Figure 2E, which is greater than the AP dimension of the periphery of the base 55 / 55A of 0.615 mm as shown in Figures 2B and 3B. Additionally, the lower (posterior) rim 91 may have a larger AP dimension than the upper (anterior) rim 93, recognizing that there is a greater potential for cellular proliferation posteriorly than anteriorly due to the presence of a capsulotomy on the anterior side, and correspondingly less tissue contact area on the anterior side. Those skilled in the art will appreciate the importance of relative dimensions, rather than specific dimensions, which are provided as examples and are not necessarily limiting, to achieve this effect.

[0039] By way of example, and not necessarily by way of limitation, the following dimensions are provided for alternative base 55-1 as shown in Figures 3A-3E. In Figure 3A, diameter A1 may be 13.00 mm ± 0.02 mm, diameter A2 may be 8.50 mm ± 0.10 mm, diameter A3 may be 7.00 mm ± 0.051 mm, diameter A4 may be 6.30 mm ± 0.051 mm, diameter A5 may be 5.50 ± 0.15 / -0.05 mm, and diameter A6 may be 7.92 mm. In Figure 3B, dimension B1 may be 0.615 mm ± 0.020 mm. In Figure 3D, dimension D1 may be 0.15 mm, dimension D2 may be 0.17 mm, dimension D3 may be 0.75 mm, dimension D4 may be 0.35 mm, dimension D5 may be 0.08 mm, and dimension D6 may be 0.30 mm ± 0.02 mm. In FIG. 3E, dimension E1 (width of notch 91A) may be 1.48 mm, dimension E2 (diameter at the outer edge of notch 93A) may be 6.62 mm, dimension E3 (inner diameter of upper rim 93) may be 6.25 mm, and dimension E4 (radians of notch 91A) may be 30 degrees.

[0040] In general, the modular IOL 90 allows for adjustment or replacement of the lens 65, both intraoperatively and postoperatively, while leaving the base 55 in place. Preferred examples of these include, but are not limited to, replacing the lens 65 for poor refractive results detected during surgery, replacing the lens 65 for poor refractive effects (residual refractive error) detected postoperatively, rotational adjustment of the lens 65 relative to the base 55 to fine-tune the torus correction, lateral adjustment of the lens 55 relative to the base 55 for axial alignment of the optics with the true optical axis (which may not be the center of the capsular bag), and replacing the lens 65 according to longer term optical needs or patient desires or wishes. Final examples include pediatric IOL patients whose need for the original optical correction changes as they become adults or mature, patients who wish to upgrade from a monofocal IOL to a premium IOL (toric, multifocal, accommodating or other future lens technology), patients who are dissatisfied with a premium IOL and wish to downgrade to a monofocal IOL, and patients who develop a medical condition that contraindicates an IOL or a particular type of IOL.

[0041] An example of a method for implanting a modular IOL 90 including a base 55 and a lens 65 is shown in Figures 4A-4D. An example of a method for removing the lens 65 from the base 55 is shown in Figures 4E-4G. After the lens 65 has been removed from the base 55 (and the eye) following the steps described with reference to Figures 4C-4D, a different lens 65 can be embedded in the same base 65.

[0042] As shown in Figure 4A, the modular IOL 90 is implanted by first loading the base 55 into the capsular bag in a rolled up position using an injector (also known as an inserter or loading tube) inserted through the corneal incision 13 and through the capsulotomy 36 into the capsular bag 34. As shown in Figure 4B, the base 55 is released from the injector and unfolded. The haptics 54 of the base 55 are gently manipulated to engage the inner equator of the capsular bag 34 and the holes 57 in the base 55 are centered relative to the capsulotomy 36.

[0043] The lens 65 is also loaded in a rolled position by using an injector to position the distal tip of the lens 65 adjacent the base 55. The lens 65 is released from the injector and spread out. The lens 65 is gently centered with respect to the capsulotomy 36. Once the base 55 is loaded into the capsule and spread out, the lens 65 is connected to the base 55 by placing tabs 95, 96 into grooves 92 to provide an interlocking connection between the base 55 and the lens 65.

[0044] 4C-4D, the lens 65 can be connected to the base 55 by first inserting the variable tab 96 into the groove 92. The variable tab 96 can then be compressed by applying a lateral force by using a probe or similar device inserted into the hole 98 of the fixed tab 95, allowing the lens 65 to advance into the hole 57 of the base 55 so that the lens 65 and base 55 are flush with each other.

[0045] The compression force is then released from the variable tab 96, allowing the fixed tab 95 to slide into the groove 92 in the base 55, connecting the lens 65 to the base 55. By using a lateral force rather than an anterior-posterior force to compress the interlocking feature, the risk of posterior tearing of the capsular bag is reduced. The probe is removed from the hole 98. To separate the lens 65 from the base 55, the reverse process is followed.

[0046] The variable tabs 96 and grooves 92 may be referred to as interlocking members, where at least one of the pair is variable to lock or unlock the connection, providing an interlocking connection between the base 55 and the lens 65. More generally, one or more interlocking connections may be provided between the base and the lens. Each interlocking connection may comprise a pair of interlocking members, one or both of which are variable. The variable interlocking members may be associated with the lens as described with respect to the modular IOL 90 of Figures 2A-2F.

[0047] As shown in Figures 4E-4G, removal of the lens begins with separating the lens from the base. As shown in Figure 4E, a probe or similar device passes through the corneal incision 13, the capsulotomy 36, and into the capsular bag 34 housing the modular IOL, e.g., modular IOL 90. As shown in Figure 4F, the probe or similar device engages the hole 98 in the stationary tab 95 and compresses the variable tab 96 by exerting a lateral force. This compression allows the stationary tab 95 to separate from the groove 92 in the base 55. With gentle manipulation, the lens 65 is lifted such that the lens 65 and the base 55 are no longer flush with each other. Once released, the compressive force is released and the variable tab 96 elastically expands to separate from the groove 92 in the base 55.

[0048] As shown in FIGURE 4G, a probe or similar device can be used to pass the lens 65 from the capsular bag 34 into the anterior chamber 15. This process does not damage the eye or increase the size of the capsulotomy 36 because the width of the lens 65 is less than the width of the capsulotomy 36. The probe or similar device can also rotate the lens 65 to an orientation where the fixed tab 95 is proximal to the corneal incision 13 and the variable tab 96 is distal to the corneal incision 13.

[0049] A typical corneal incision 13 has a width of approximately 2.2 mm, which is less than the outer diameter of the lens 65. Thus, mechanical manipulation of the lens 65 may be required to remove the lens 65 from the anterior chamber 15 through the corneal incision 13. The lens 65 may be manipulated, e.g., cut, so that it can be withdrawn through the corneal incision as a single piece or as multiple pieces. A cannula or tube facilitates this removal.

[0050] A conventional injector (known as an inserter) may be used to load the base 55 and lens 65. Examples of suitable injectors are described in U.S. Pat. Nos. 5,123,905, 4,681,102, 5,304,182, and 5,944,725. Injectors such as these may be configured to load the base 55 and lens 65 separately, as described with reference to FIGS. 4A-4G. Alternatively, the base 55 and lens 65 may be loaded in series for serial (i.e., sequential) loading, or may be preassembled and loaded for parallel (i.e., simultaneous) loading. Examples of alternative injector configurations facilitating serial or parallel loading are shown in FIGS. 5A-5D.

[0051] 5A, an alternative injector 100 includes a tubular barrel 102 having a single internal lumen with a plunger 104 disposed therein. A distal end 106 of the barrel 102 is tapered for insertion into a corneal incision. A pair of in-line cartridges 108A, 108B are disposed within the barrel 102 and are configured to hold a base 55 and a lens 65, respectively, in a rolled position (not visible). The cartridges 108A, 108B may be configured as disclosed in the above-mentioned U.S. Pat. No. 4,681,102, except that two in-line cartridges are provided instead of one. As an alternative to the cartridges 108A, 108B, the base 55 and lens 65 may be pre-disposed within the barrel 102 or may be disposed within the barrel 102 via a side loading opening as described in the above-mentioned U.S. Pat. No. 5,123,905 to Kelman. Optionally, a spacer 107 may be disposed within barrel 102 between cartridges 108A and 108B. As plunger 104 advances within barrel 102, the distal end of plunger 104 pushes lens 65 out of cartridge 108B, forcing spacer 107 (if used) into engagement with base 55 disposed in cartridge 108A. Continued advancement of plunger 104 forces base 55 into the eye through distal end 106 of injector 100, followed by lens 65. Lens 65 is then attached to base 55 within the eye. Spacer 107 may be tethered to the injector to avoid implantation within the eye, and may be formed of a dissolvable material that is safe for entry into the eye. The base 55 may have a smaller volume (i.e., less material) than the lens 65 so that the force required to advance the base 55 within the barrel 102 is lower than the force required to advance the lens 65 within the barrel 102, thereby reducing the tendency for the lens 65 to jam as it is pressed against the base 55 inside the barrel 102.

[0052] 5B, another alternative injector 110 includes a tubular barrel 102 having two parallel internal lumens separated by an internal wall 103 and having a pair of plungers 104A and 104B disposed therein. A distal end 106 of the barrel 102 includes a single common lumen where the two parallel lumens meet and terminate at the wall 103. The distal end 106 of the barrel 102 is tapered for insertion into a corneal incision. A pair of parallel cartridges 108A, 108B are disposed within the barrel 102 and are configured to hold a base 55 and a lens 65, respectively, in a rolled position (not visible) in each of the parallel lumens. The cartridges 108A, 108B may be configured as disclosed in the above-mentioned U.S. Pat. No. 4,681,102, except that two parallel cartridges are provided instead of one. As an alternative to cartridges 108A, 108B, base 55 and lens 65 may be pre-placed in barrel 102 or may be placed in barrel 102 through a side loading opening as described in the above-mentioned U.S. Pat. No. 5,123,905. As plunger 104A advances in barrel 102, the distal end of plunger 104A pushes base 55, which is placed in cartridge 108A, out of cartridge 108A and into the eye through distal end 106 of injector 100. Plunger 104A then retracts to its original position. Plunger 104B is then advanced into barrel 102 to compress lens 65 and place cartridge 108B out of distal end 106 of injector 100 into the eye. Lens 65 is then attached to base 55 inside the eye.

[0053] 5C, another alternative injector 120 includes a tubular barrel 102 having a single inner lumen with a pair of coaxial plungers 104C, 104D disposed therein. The inner plunger 104C is configured to be axially movable inside the outer tubular plunger 104D. The distal end 106 of the barrel 102 is tapered for insertion into a corneal incision. A pair of in-line cartridges 108A, 108B are disposed within the barrel 102 and configured to hold the base 55 and the lens 65, respectively, in a rolled position (not visible). The in-line cartridges 108A, 108B may be configured as disclosed in the above-mentioned U.S. Pat. No. 4,681,102 to Bartell, except that two in-line cartridges are provided instead of one. As an alternative to cartridges 108A, 108B, base 55 and lens 65 may be pre-placed in barrel 102 or may be placed in barrel 102 via a side loading opening as described in the aforementioned U.S. Pat. No. 5,123,905. Lens 65 rolls around the axis of inner plunger 104C, which is slidable through lens 65. As inner plunger 104C advances inside outer plunger 104D and barrel 102, the distal end of inner plunger 104C pushes base 55 out of cartridge 108A. Continued advancement of inner plunger 104C causes the distal end of inner plunger 104C to push base 55 out of distal end 106 of injector 100 and into the eye. Inner plunger 104C then retracts to its original position. The outer plunger 104D then advances outside the inner plunger 104C, causing the distal end of the outer plunger 104D to push the lens 65 out of the cartridge 108B. Continued advancement of the outer plunger 104D causes the distal end of the outer plunger 104D to push the lens 65 out of the distal end 106 of the injector 100 and into the eye. The lens 65 is then attached to the base 55 in the eye.

[0054] Referring to FIG. 5D, another alternative injector 130 includes a tubular barrel 102 having a single internal lumen with a plunger 104 disposed therein. The distal end 106 of the barrel 102 is tapered for insertion into a corneal incision. A pair of side-by-side cartridges 108A, 108B are disposed in lateral slot extensions 109A, 109B, respectively. The cartridges 108A, 108B are configured to hold a base 55 and a lens 65 in a rolled position (not visible). The cartridges 108A, 108B may be configured as disclosed in the above-mentioned U.S. Pat. No. 4,681,102, except that two side-by-side cartridges are provided instead of one. As an alternative to the cartridges 108A, 108B, the base 55 and lens 65 may be pre-disposed in the barrel 102, or may be disposed in the barrel 102 via a side loading opening, as described in the above-mentioned U.S. Pat. No. 5,123,905.

[0055] Continuing to refer to FIG. 5D, the side-by-side cartridges 108A, 108B slide laterally inside the slot extensions 109A, 109B such that when pressed into a first position (downward as shown) the base 55 contained in the cartridge 108A is aligned with the internal lumen of the barrel 102, and when pressed into a second position (upward, not shown) the lens 65 contained in the cartridge 108B is aligned with the internal lumen of the barrel 102. First, the cartridge 108A containing the base 55 is pressed into the slot extension 109A to position it within the barrel 102. As the distal end of the plunger 104 advances within the barrel 102, the distal end of the plunger 104 pushes the base 55 out of the cartridge 108A and into the eye through the distal end 106 of the injector 100. The plunger 104 then retracts to its original position (as shown). Cartridge 108B is then pushed into slot extension 109B into barrel 102 while pushing empty cartridge 108A out of barrel 102 and into slot extension 109A. Plunger 104 then advances within barrel 102 to push lens 65 out of cartridge 108B and into the eye from distal end 106 of injector 100. Lens 65 is then attached to base 55 within the eye. Cartridges 108A, 108B may be manually slid as described above, or may be moved automatically, for example using a spring, such that cartridge 108B containing lens 65 presses into barrel 102 when plunger 104 is retracted after base 55 is loaded from cartridge 108A.

[0056] As mentioned above, the base 55 and the lens 65 can be loaded in series or in parallel. For parallel loading, the lens 65 may be preassembled with the base 55, rolled together, and then loaded into the injector for loading into the eye, without the need to assemble the two parts in the eye. A meltable adhesive, a cuttable member (e.g., a tab, tether, or hinge that can be cut by cutting or laser ablation), or other temporary connection means may be used to maintain the assembled bond between the base 55 and the lens 65 during the rolling, loading, and loading steps. Alternatively, the lens 65 may be stacked on the base 55 (without assembling the two), rolled together, loaded into the injector, loaded into the eye, and then assembled in the eye.

[0057] 6A-6C show another alternative base 55B for use with modular IOL 90. FIG. 6A is a perspective view of base 55B, FIG. 6B is a top (front) view of base 55B, and FIG. 6C is a CC perspective cross-sectional view of base 55B of FIG. 6B. Alternative base 55B is similar to base 55 except for the shape of groove 92 and the overall size of base 55B. All similar aspects of the previous embodiment are applicable to this embodiment as well.

[0058] In this embodiment, the groove 92 is defined by a forwardly sloping upper rim or wall 93, an inwardly facing sidewall 94, and a rearwardly sloping lower rim or wall 91. The upper rim 93 may be sloping forward, for example, at 30 degrees from the plane of the groove 92, and the lower rim 91 may be sloping rearward, for example, at 30 degrees from the plane of the groove 92.

[0059] The sidewall 94 can have a height (front-to-back dimension) that matches the thickness of the tabs 95 and 96. The sidewall 94 can have a straight shape that matches the outermost walls of the tabs 95 and 96. The sidewall 94 intersects with the upper rim 93 and lower rim 91 to form an inner corner. Compared to a curved intersection, the inner corner can provide better anterior-posterior stability of the tabs 95, 96 inside the groove 92, which in turn provides better anterior-posterior stability of the lens 65 relative to the base 55B.

[0060] The opening of groove 92 has a dimension defined by the distance between upper rim 93 and lower rim 91 along the inner diameter of rims 91, 93. The opening dimension of groove 92 is approximately larger than the thickness of tabs 95, 96 to facilitate insertion of lens 95 into base 55B. In one example, the opening dimension of groove 92 is 1.5 times the thickness of tabs 95 and 96. In another example, the opening dimension of groove 92 is 2.0 times the thickness of tabs 95 and 96. The large opening of groove 92 allows for quick and easy insertion of lens 65 into base 55B.

[0061] Commercially available IOLs typically have an equatorial diameter (excluding haptics) of about 6 mm, an anterior-posterior thickness of about 0.2 mm at the 6 mm diameter and 0.7 mm at the center, resulting in a total thickness of about 12 mm. 3 The lens 65 is similarly sized, but adds substantially more volume to the base 55B. The base 55B has an equatorial diameter (excluding haptics 54) of approximately 8.5 mm, a front-to-back thickness of approximately 1 mm at the 8.5 mm diameter, and 2.5 mm at the 6 mm diameter, providing a total volume of approximately 67 mm when the lens 65 is placed on the base 55B. 3 The combined base 55B and lens 65 dimensions are therefore much larger in volume than conventional IOLs available on the market. This relatively large volume is intended to fill the capsular bag like a natural lens, thereby increasing the stability of the base 55B and reducing post-operative displacement due to damage to the capsular bag around the base 55B. For comparison, a typical natural lens has a volume of approximately 180 mm 3The natural lens has an equatorial diameter of about 10.4 mm and an anterior-posterior dimension of about 4.0 mm, corresponding to the cornea. Due to anatomical variations, the natural lens has an equatorial diameter of about 130 mm. 3 From 250mm 3 Thus, the base 55B and lens 65 consume approximately 50% to 25% of the capsule volume after the natural lens is extracted, as opposed to approximately 10% to 5% of the capsule volume consumed by a conventional IOL.

[0062] 7A-7B show an alternative lens 65A for use in modular IOL 90. FIG. 7A is a perspective view of alternative lens 65A and FIG. 7B is a top (front) view of lens 65A. Alternative lens 65A has a similar design and function to lens 65, except for notch 98A in stationary tab 95 and alternative variable tab 96A. All similar aspects of the previous embodiments are applicable to this embodiment.

[0063] Specifically, the alternative lens 65A includes an optic 97, one or more stationary tabs 95, and one or more variable tabs 96A. Optionally, the stationary tabs 95 may be replaced with a variable tab (e.g., like tab 96A). The stationary tabs 95 may include a through hole 98 so that a probe or similar device may be used to engage and manipulate the tabs 95. The stationary tabs 95 may also include a notch 98A positioned counterclockwise of the hole 98 (or another portion of the tab 95 counterclockwise) to provide an indication that the anterior side of the lens 65A is on the right side when implanted. In other words, when the lens 65A is positioned on the base 55, if the notch 98A is positioned counterclockwise of the hole 98, the anterior side of the lens 65A is correctly positioned forward. If the notch 98A is positioned clockwise of the hole 98, the anterior side of the lens 65A is incorrectly positioned backward. Another indication of the correct anterior-posterior orientation of lens 65A can be adopted by providing two markers around the periphery of lens 65A, designating their correct relative position (clockwise or counterclockwise).

[0064] The variable tab 96A is variable between a compressed position for insertion into the hole 57 of the base 55 and a non-compressed expanded position (as shown) for deployment into the groove 92 of the base 55, thus forming an interlocking connection between the base 55 and the lens 65A. The variable tab 96A includes two members 96A1, 96A2, each having one end connected to the peripheral rim 97A of the optic 97 and a free end, thereby forming two cantilever springs. Compared to the variable tab 96 (shown in Figs. 2D-2F) that has two ends attached to the periphery of the optic 97 and a center joined like a single leaf spring, the variable tab 96A includes two cantilever spring-like members 96A1, 96A2, each having one end attached to the peripheral rim 97A of the optic 97 and the other end being a free end. A notch 96A3 may be formed in the peripheral rim 97A between the two members 96A1, 96A2 to add hinge-like flexibility to the two members 96A1, 96A2 where they are attached to the peripheral rim 97A. The notch 96A3 also provides access for a probe or similar device to manipulate the tab 96A into the groove 92 in the base 55.

[0065] As shown in Figures 7A and 7B, the two cantilevered members 96A1, 96A2 of the variable tab 96A are attached at one end to the peripheral rim 97A of the optic 97 and extend radially outwardly away from each other in an arc. In this configuration, compared to the variable tab 96 shown in Figures 2D-2F, the cantilevered members 96A1, 96A2 engage the side walls 94 defining the groove 92 of the base 55 at two spaced apart locations. The lens 65A is connected to the base 55 at three spaced apart locations with the stationary tabs 95 contacting portions of the diametrically opposite side walls 94, providing relatively enhanced planar stability.

[0066] Optionally, one or both of the two cantilevered members 96A1, 96A2 may include a hole 96A4 as shown in FIG. 7C. The hole 96A4 may be sized and configured to receive an intraocular tool, such as a Sinskey hook, that can be used to rotate the lens 65A when placed in the base 55. This facilitates relative rotational adjustment of the lens 65A with respect to the base 55 to aid in adjusting the toric application. Such a mechanism may be incorporated into either the fixed or variable tabs described herein.

[0067] 8A-8B show yet another alternative lens 65B for use in the modular IOL 90. FIG. 8A shows a perspective view of the lens 65B, and FIG. 8B shows a plan view of the lens 65B. The alternative lens 65B has a similar design and function to the lens 65A, except for an alternative variable tab 96B that includes two cantilevered members 96B1 and 96B2. All similar aspects of the previous embodiment are applicable to this embodiment. In this embodiment, the two cantilevered members 96B1 and 96B2 of the variable tab 96B are attached to one end of the peripheral rim 97A of the optic 97 and extend radially outward in an arc toward each other (rather than away from each other). This configuration is similar to the variable tab 96 shown in FIGS. 2D-2F, except that the members 96B1 and 96B2 are separated and form a pair of cantilevered springs rather than a leaf spring.

[0068] Optionally, the drug may be contained in or carried by the base 55. Using the base 55 as a carrier for the drug has many advantages as opposed to the lens 65. For example, it avoids interference of the optical performance of the lens 65 with the drug or drugs. Also, since there is no need to invert the base 55, as is done as part of the manufacturing process of the lens 65, the base 55 is not exposed to potential damage. Drugs can be incorporated into the base 55 by connecting one or more separate drug carriers to the base 55 that have the material of the base 55 (e.g., like a sponge) and act as a drug carrier, by incorporating one or more drug-eluting materials into the base 55, or by incorporating one or more refillable reservoirs carrying the drug into the base 55. One or more parts of the base 55 may carry one or more drugs, and these parts may be separated from each other, for example to avoid interactions between different drugs. The drug-carrying portion or portions of base 55 can be selectively activated by light or thermal energy (e.g., laser, UV light, etc.) to release the stored drug or drugs all at once or sequentially over time.

[0069] Examples of clinical indications for such drugs include wet or dry macular degeneration, open or closed glaucoma, uveitis, posterior capsule opacification, post-operative management after cataract surgery, etc. Examples of drugs that can be used for wet macular degeneration include aflibercept, bevacizumab, pegaptanib, ranibizumab, steroids, and aptamers. Examples of drugs that can be used for dry macular degeneration include complement factors, antioxidants, and anti-inflammatory agents. Examples of drugs that can be used for open-angle glaucoma include brimonidine, latanoprost, timolol, pilocarpine, brinzolamide, and other drugs in the general categories of beta-receptor agonists, alpha-agonists, ROCK inhibitors, adenosine receptor agonists, carbonic anhydrase inhibitors, adrenergic and cholinergic receptor activators, and prostaglandin analogues. Examples of drugs that can be used for uveitis include memethotrexate, antibodies, dexamethasone, triamcinolone, and other steroids. Examples of drugs that can be used for posterior capsule opacification include antiproliferative, antimitotic, anti-inflammatory, and other drugs that inhibit the spreading of lens epithelial cells. Examples of drugs that can be used for postoperative management after cataract surgery include antibiotics such as fluoroquinolones, nonsteroidal drugs such as ketorolac, and steroids such as prednisolone. Other drugs available for treating various ocular diseases and conditions include anti-fibrotic agents, anti-inflammatory agents, immunosuppressants, antineoplastic agents, migration inhibitors, anti-proliferative agents, rapamycin, triamcinolone acetonide, everolimus, tacrolimus, paclitaxel, actinomycin, azathioprine, dexamethasone, cyclosporine, bevacizumab, anti-VEGF agents, anti-IL-1 agents, canakinumab, anti-IL-2 agents, viral vectors, beta blockers, alpha agonists, muscarinic agents, steroids, antibiotics, non-steroidal anti-inflammatory agents, prostaglandin analogs, ROCK inhibitors, nitric oxide, endothelin, matrix metalloproteinase inhibitors, CNPA, corticosteroids, and antibody-based immunosuppressants. These drugs can be used alone or in combination depending on the patient's unique clinical condition.

[0070] Additionally, the drug or drug-carrying portions of base 55 may be oriented in certain directions while other directions are masked or blocked to increase drug concentration in certain portions of the capsular bag, for example, to focus drug injection to posterior ocular structures (e.g., to alleviate macular degeneration) and to focus drug injection to anterior ocular structures (e.g., to inject glaucoma drugs adjacent the angle or to inject drugs for uveitis or post-operative management following cataract surgery).

[0071] As an example, FIG. 9 shows a top (front) view of a base 55 incorporating one or more drug carriers 50. As shown, the drug carriers 50 are spaced circumferentially around the front of the body of the base 55. The drug carriers 50 may comprise refillable reservoirs (e.g., silicone containers), elutable porous materials (e.g., biocompatible sponges), biodegradable or biodegradable materials (e.g., PLGA), etc. The reservoirs are subject to exposing the drug to an aqueous environment by laser, UV light, RF signals, magnetic manipulation, or other methods to remotely remove the diffusion barrier. The carriers 50 may be disposed on the surface of the base 55, for example, or may be embedded therein. To focus the infusion of the drug to a particular area of ​​the eye, the carriers 50 may be exposed on one side (e.g., the front side as shown) while the material of the base 55 covers the other side.

[0072] Similarly, one or more microelectronic sensors may be incorporated into or mounted on the base 55. The use of the base 55 as a carrier for the sensors has many advantages as opposed to the lens 55. For example, it avoids any interference that the sensor may experience due to the optical performance of the lens 65. Also, since there is no need to invert the base 55, as is done as part of the manufacturing process for the lens 65, the sensors carried by the base 55 are not exposed to potential damage.

[0073] As shown in FIG. 10, which is a plan (front) view of the base 55, the sensor 70 may be attached to or embedded in the base 55, similar to the drug carrier 50 described with reference to FIG. 9. The sensor 70 may be connected to an integrated control circuit 72, which is connected to an antenna 74. The control circuit 72 may include a transmitter or transceiver circuit for wirelessly transmitting sensor data to an external device via the antenna 74. The control circuit 72 may include a power circuit that receives power via an inductive link to an external power source. Examples of sensors suitable for incorporation into or retention on the base 55 include biological sensors such as glucose sensors, electrolyte sensors, protein sensors, temperature sensors, conductivity sensors, electric field sensors, pressure sensors (e.g., for measuring intraocular pressure), pulse oximeter sensors, or light sensors for supporting artificial vision. Examples of microelectronic sensors for use in contact lenses are described in U.S. Patent Application Publication Nos. 2014 / 0085599, 2014 / 0084489, 2014 / 0085602, and 2014 / 0087452, 2014 / 0085600, 2014 / 0088381, 2014 / 0192311, 2014 / 0194710, 2014 / 0194713, 2014 / 0194773, 2014 / 0098226, and 20140081178, and WO 2014 / 204575. Such microelectronic sensors for use in contact lenses may be hermetically sealed within base 55 for ocular implant applications. Sensor 70 may include a permeable cover for direct biological interface applications (glucose sensor, electrolyte sensor, protein sensor, etc.). Alternatively, sensor 70 may include a non-permeable cover for indirect biological interface applications (pressure sensor, temperature sensor, conductivity sensor, electric field sensor, etc.).

[0074] (Additional Note) As a preferred embodiment, the technical ideas that can be understood from the above embodiment will be described below. [Item 1] 1. A device configured for intraocular insertion, comprising: The apparatus comprises an annular base; The annular base includes: a front portion surrounding a front opening and having a rear surface; a rear portion surrounding the rear opening; a wall extending between the forward portion and the aft portion and having a radially inner surface; a passageway extending through the annular base from the front opening to the rear opening; a recess surrounding the passage and defined by the rear surface of the forward portion, the radially inner surface of the wall, and a front surface of the rear portion; Equipped with The apparatus includes a lens, the lens comprising: The optical part, a non-deformable first tab protruding from the optic portion; and a second tab protruding from the optic portion diametrically opposite the first tab, the second tab being a pair of cantilever springs having one end attached to the optic body and the other end free; Including, the second tab is deformable between (i) a radially compressed position and (ii) an uncompressed, expanded position to interlock the lens and the annular base. [Item 2] Item 2. The apparatus of item 1, wherein the rear portion of the annular base forms a conical frustum. [Item 3] Item 2. The apparatus of item 1, wherein the radially inner surface of the wall forms a cylindrical shape. [Item 4] 2. The apparatus of claim 1, wherein the rear surface of the annular base extends straight from a forward end of the radially inner surface of the wall to the front opening. [Item 5] Item 2. The apparatus of item 1, wherein an obtuse angle is formed between the rear surface of the forward portion and a radially inner surface of the forward portion. [Item 6] Item 2. The device of item 1, wherein the front opening is wider than the rear opening. [Item 7] Item 2. The device of item 1, wherein the axial thickness measured between the front surface of the front portion and the rear surface of the rear portion is at least 1 mm. [Item 8] Item 1. The device of item 1, wherein an axial thickness measured between a front surface of the front portion and a rear surface of the rear portion is between 1 mm and 2.5 mm. [Item 9] 2. The device of claim 1, wherein the ratio of the axial thickness of the annular base to the diameter of the annular base is between 0.12 and 0.29. [Item 10] 1. A device configured for intraocular insertion, the device comprising an annular base; The annular base includes: A central longitudinal axis; an equatorial plane extending perpendicular to the central longitudinal axis; a forward portion surrounding a front opening and having a front surface and a rear surface, the front surface and the rear surface extending transversely to the equatorial plane; a rear portion surrounding the rear opening; a wall extending between the forward portion and the aft portion and having a radially inner surface; a passageway extending through the base from the front opening to the rear opening; a recess surrounding the passage and bounded by a rear surface of the forward portion, the radially inner surface of the wall, and the rear portion; Equipped with The apparatus includes a lens, the lens comprising: The optical part, a first tab protruding from the optical portion; and a second tab protruding from the optical portion in a diametrically opposed relationship to the first tab, the second tab being a pair of cantilever springs having one end attached to the optical portion and the other end free; wherein the second tab is deformable between (i) a radially compressed position and (ii) an uncompressed, expanded position to interlock the lens and the annular base. [Item 11] Item 11. The apparatus of item 10, wherein an obtuse angle is formed between the rear surface of the forward portion and the radially inner surface of the wall. [Item 12] Item 11. The apparatus of item 10, wherein the forward portion includes a radially inner surface extending from the front surface to the rear surface of the forward portion. [Item 13] Item 11. The device of item 10, wherein the axial thickness of the annular base is at least 1 mm. [Item 14] Item 11. The device of item 10, wherein the axial thickness of the annular base is between 1 mm and 2.5 mm. [Item 15] Item 11. The device of item 10, wherein the diameter of the annular base is 8.5 mm. [Item 16] Item 11. The device of item 10, wherein the ratio of the axial thickness of the annular base to the diameter of the annular base is between 0.12 and 0.29. [Item 17] Item 1, wherein the first tab includes a hole. The above discussion of the present invention has been presented for purposes of illustration and description. The above is not intended to limit the present invention to the form invented herein. Although the description of the present invention includes one or more embodiments and descriptions of certain alternatives and modifications, other alternatives and modifications are within the scope of the present invention, such as those within the skill and knowledge of one of ordinary skill in the art after understanding the present invention. The present invention is intended to be entitled to include, to the extent permitted, alternative embodiments that include alternative, interchangeable, equivalent structures, functions, ranges, or steps to those claimed, whether or not such alternative, interchangeable, equivalent structures, functions, ranges, or steps are invented herein, and is not intended to subject the public to patentable subject matter.

Claims

1. 1. A device configured for intraocular insertion, comprising: the device comprises a forward portion surrounding a front opening, a portion of the forward portion being angled such that as the forward portion extends toward the front opening, the forward portion extends further forward; the device comprises a rear portion surrounding a rear opening, a portion of the rear portion being angled such that as the rear portion extends toward the rear opening, the rear portion extends further rearward; The apparatus includes an inwardly facing sidewall extending between the forward portion and the rearward portion; the apparatus includes a passageway extending through the apparatus from the front opening to the rear opening; the apparatus includes a recess surrounding the passageway, the recess being defined by a rear surface of the forward portion, the inwardly facing sidewall, and a front surface of the rear portion; the recess comprises a first angle formed by the inwardly facing sidewall and a rear surface of the anterior portion and a second angle formed by the inwardly facing sidewall and the front surface of the posterior portion, and the recess is configured to surround a portion of a lens configured to be received within the recess.

2. The device of claim 1, wherein the axial thickness measured between the front surface of the forward portion and the rear surface of the rear portion is at least about 1 mm.

3. The device described in claim 2, wherein the axial thickness is between approximately 1 mm and 2.5 mm.

4. The device described in claim 1, wherein the forward portion is inclined forward approximately 30 degrees relative to the equatorial plane of the device.

5. The device described in claim 1, wherein the rear portion is inclined rearward at approximately 30 degrees relative to the equatorial plane of the device.

6. The device described in claim 1, further comprising a pair of haptics.

7. The device described in claim 1, wherein the lens includes at least one tab.

8. The device of claim 7, wherein the lens includes a plurality of tabs.

9. A device configured for intraocular insertion, comprising: The apparatus includes an annular base, the annular base including: A central longitudinal axis; an equatorial plane extending perpendicular to the central longitudinal axis; a forward portion surrounding a front opening and having a front surface and a rear surface, the front surface and the rear surface extending transversely to the equatorial plane; a rear portion surrounding the rear opening; an inwardly facing sidewall extending between the forward portion and the rearward portion; a passageway extending through the base from the front opening to the rear opening; a recess surrounding the passage; the recess is defined by the rear surface of the forward portion, the inwardly facing sidewall, and a front surface of the rear portion; the recess comprises a first angle formed by the inwardly facing sidewall and the rear surface of the anterior portion and a second angle formed by the inwardly facing sidewall and the front surface of the posterior portion, and the recess is configured to surround a portion of a lens configured to be received within the recess.

10. The apparatus of claim 9, wherein the first angle is an obtuse angle.

11. The device of claim 9, wherein the forward portion includes a radially inner surface extending from the front surface to the rear surface of the forward portion.

12. The device described in claim 9, wherein the axial thickness of the annular base is at least about 1 mm.

13. The device of claim 9, wherein the axial thickness of the annular base is between about 1 mm and 2.5 mm, and the diameter of the annular base is about 8.5 mm.

14. The device described in claim 9, wherein the ratio of the axial thickness of the annular base to the diameter of the annular base is between about 0.12 and 0.

29.

15. The device described in claim 9, wherein the annular base further comprises a pair of haptics.

16. The device of claim 9, wherein the lens includes at least one tab.

17. A device configured for intraocular insertion, comprising: The apparatus includes an annular base, the annular base including: a front portion surrounding a front opening and having a rear surface; a rear portion surrounding the rear opening; an inwardly facing sidewall extending between the forward portion and the rearward portion; a passageway extending through the base from the front opening to the rear opening; a recess surrounding the passage; the recess is defined by the rear surface of the forward portion, the inwardly facing sidewall, and a front surface of the rear portion; the recess comprises a first angle formed by the inwardly facing sidewall and the rear surface of the anterior portion and a second angle formed by the inwardly facing sidewall and the front surface of the posterior portion, the first angle being an obtuse angle, and further wherein the recess is configured to surround a portion of a lens configured to be received within the recess.

18. The device of claim 17, wherein the front opening is wider than the rear opening.

19. The device described in claim 17, wherein the ratio of the axial thickness of the annular base to the diameter of the annular base is between about 0.12 and 0.

29.

20. The device of claim 17, wherein the lens includes a plurality of tabs.