Design and Method of Modular Intraocular Lenses

Abstract

To provide a method that allows for correction or modification of the optical result using a secondary lens that can be attached to a primary lens without the need to manipulate an IOL system and a lens capsule.SOLUTION: Provided is an intraocular lens system for implantation into a lens capsule having a capsulorhexis with a perimeter, comprising an intraocular primary component and an intraocular secondary component, the primary component being configured to releasably receive and connect to the secondary component to provide optical correction. The intraocular primary component has a body and one or more haptics, the primary component being configured to fit within the lens capsule, and the body having an equatorial perimeter greater than or equal to the perimeter of the capsulorhexis. The intraocular secondary component has an optical body with an equatorial perimeter less than the perimeter of the capsulorhexis.SELECTED DRAWING: Figure 2A

Description

Technical Field

[0001] The present disclosure generally relates to embodiments of an intraocular lens (IOL). In particular, the present disclosure relates to embodiments of the design and method of a modular IOL.

Background Art

[0002] The human eye functions to provide vision by transmitting light through a transparent outer portion called the cornea and forming an image on the retina by the crystalline lens. The quality of the formed image depends on many factors including the size and shape of the eye and the transparency of the cornea and lens.

[0003] When the transparency of the lens decreases due to age or disease (e.g., clouding), the amount of light transmitted to the retina decreases, resulting in a decrease in visual acuity. This lens defect of the eye is medically known as cataract. The established treatment for this condition is to surgically remove the lens from the lens capsule and place an artificial intraocular lens (IOL) inside the lens capsule. In the United States, most cataract lenses are removed by a surgical technique called phacoemulsification. During this procedure, an opening (capsulotomy) is created in the front of the lens capsule, and a thin phacoemulsification resection tip is inserted into the affected lens and vibrates ultrasonically. The vibrating resection tip liquefies or emulsifies the lens so that the lens can be aspirated from the lens capsule. The affected lens is removed and replaced with an IOL.

[0004] After cataract surgery for implanting an IOL, the optical results may not be optimally satisfied or may require adjustment over time. For example, soon after the procedure, there may be an error in refractive correction, leading to what is sometimes called an "unexpected refraction." Also, for example, after a long period of time after the procedure, the patient may be determined to need or desire different corrections such as stronger refractive correction, astigmatism correction, or multifocal correction.

[0005] In each of these cases, surgeons may hesitate to remove a suboptimal IOL from the lens capsule and replace it with a new one. Generally, manipulating the lens capsule to remove an IOL carries the risk of damaging the lens capsule, including subsequent rupture. This risk increases over time as the lens capsule collapses around the IOL and tissue growth surrounds the IOL's support. Therefore, it is desirable to be able to correct or alter the optical outcome without removing the IOL or manipulating the lens capsule.

[0006] Various auxiliary lenses have been proposed to address the aforementioned drawbacks. For example, one possible solution involves an auxiliary lens located anterior to the lens capsule with its support engaged in the ciliary sulcus. While this design may have the advantage of avoiding manipulation of the lens capsule, its main drawback is engagement with the ciliary sulcus. The ciliary sulcus consists of soft, neovascularized tissue that is easily damaged when engaged by the support or other materials. Such damage can lead to complications such as bleeding, inflammation, and anterior chamber hemorrhage. Therefore, generally speaking, it would be desirable to avoid placing auxiliary lenses within the ciliary sulcus to avoid the possibility of complications.

[0007] Another potential solution may include a lens system that avoids potential challenges associated with the ciliary sulcus. The lens system may include a primary lens and a secondary lens. The secondary lens may be attached to the primary lens, and both are located within the lens capsule. The primary lens may have a recess into which the rim of the secondary lens may be inserted for attachment. The recess is preferably located radially lateral to the opening (capsular incision) within the lens capsule to avoid interference with light transmission. To attach the secondary lens in situ, the lens capsule must be manipulated around the capsular incision to gain access to the recess of the primary lens. As previously mentioned, manipulation of the lens capsule may be undesirable given the associated risks. Therefore, while such lens systems can avoid potential damage to the ciliary sulcus by implanting both the primary and secondary lenses within the lens capsule, these systems do not avoid manipulation of the lens capsule for attaching the secondary lens. [Overview of the project] [Problems that the invention aims to solve]

[0008] Therefore, there remains a demand for methods that allow for correction or modification of optical results using IOL systems and secondary lenses that can be attached to the primary lens without the need to manipulate the lens capsule. [Means for solving the problem]

[0009] Embodiments of the present disclosure provide a modular IOL system comprising an intraocular main component and a secondary component, which, when combined, form an intraocular optical correction device. The main component may include an intraocular base, and the secondary component may include an intraocular lens. The base is configured to removably receive the intraocular lens. In some embodiments, the base may be configured as a lens, in which case the modular IOL system may be described as comprising a main lens and a secondary lens. The main component (e.g., the base or main lens) may be placed in the lens capsule using conventional cataract surgery techniques. The main component may have a diameter larger than the diameter of the capsulotomy to retain the main component in the lens capsule. The secondary component (e.g., the secondary lens) may have a diameter smaller than the diameter of the capsulotomy so that the secondary component can be attached to the main component without manipulating the lens capsule. The secondary component may also be manipulated intraoperatively or postoperatively to correct or modify the optical outcome without removing the main component and without manipulating the lens capsule. For example, sub-components may be removed, rearranged, and / or replaced in order to correct, modify, and / or fine-tune the optical results.

[0010] Common signs of the need for replacement of secondary components may include residual refractive errors (e.g., monofocal lenses), eccentricity errors due to postoperative healing (e.g., multifocal lenses), astigmatism errors induced by surgery (e.g., toric lenses), changes in optical correction needs due to progressive disease, changes in lifestyle, injury, age, etc.

[0011] The main component may have a support portion (e.g., a projection) extending from it for centering within the lens capsule, while the secondary component may omit the support portion and instead rely on the attachment portion of the main component for stability. Such attachment portions may be radially inward around the capsular incision and radially outward from the field of view to avoid interference with light transmission. Alternatively or in addition, to minimize the possibility of interference with light transmission, the attachment portion may include a small portion (e.g., less than 20%) around the secondary component.

[0012] The main component may have a front surface that is in close contact with the rear surface of the secondary component to prevent the intrusion of bodily fluids, tissue endoplastic growth, and / or optical interference. The secondary component may be detachably fixed to the main component, for example, by a mechanical attachment and / or chemical attraction. The mechanical attachment can be facilitated by a fitting or interlocking structure corresponding to the main component and the secondary component, respectively. Such structures may be pre-formed, for example, by molding or cutting, or formed in situ in vivo, for example, by laser etching. Chemical attraction may be facilitated, for example, by using similar materials having a smooth surface finish activated by surface treatment. In some cases, it may be desirable to reduce chemical attraction and rely more on a mechanical attachment for stability. In this case, the main component and the secondary component may be formed of different materials, or may have adjacent surfaces that otherwise do not have chemical attraction.

[0013] The modular IOL systems and methods according to embodiments of the present disclosure may be applied to various IOL types, including fixed monofocal, multifocal, toric, adjustable, and combinations thereof. In addition, the modular IOL systems and methods according to embodiments of the present disclosure may be used, for example, to treat cataracts, large optical errors in myopic (myopia), hyperopic (hyperopia) and astigmatic eyes, vitreous transposition, aphakia, pseudophakia, and nuclear sclerosis.

[0014] Various other embodiments of the embodiments of this disclosure are described in the following detailed description and drawings. The drawings illustrate embodiments of the present disclosure. The drawings are not drawn to a fixed scale and include similar elements with the same reference numerals, which may include, but are not limited to, dimensions (millimeters) and angles (degrees). [Brief explanation of the drawing]

[0015] [Figure 1] A schematic diagram of a human eye shown in cross-section. [Figure 2A]A front cross-sectional view of a modular IOL (intraocular lens) arranged within a lens capsule according to one embodiment of the present disclosure. [Figure 2B] A side cross-sectional view of a modular IOL (intraocular lens) positioned within a lens capsule according to one embodiment of the present disclosure. [Figure 3A] A schematic front cross-sectional view illustrating a method for implanting a modular IOL according to one embodiment of the present disclosure. [Figure 3B] A schematic front cross-sectional view illustrating a method for implanting a modular IOL according to one embodiment of the present disclosure. [Figure 3C] A schematic front cross-sectional view illustrating a method for implanting a modular IOL according to one embodiment of the present disclosure. [Figure 3D] A schematic front cross-sectional view illustrating a method for implanting a modular IOL according to one embodiment of the present disclosure. [Figure 4A] A schematic side cross-sectional view illustrating a method for implanting a modular IOL according to one embodiment of the present disclosure. [Figure 4B] A schematic front cross-sectional view illustrating a method for implanting a modular IOL according to one embodiment of the present disclosure. [Figure 4C] A schematic front cross-sectional view illustrating a method for implanting a modular IOL according to one embodiment of the present disclosure. [Figure 4D] A schematic front cross-sectional view illustrating a method for implanting a modular IOL according to one embodiment of the present disclosure. [Figure 5] A front view of a modular IOL according to one embodiment of the present disclosure, in which an under-surface mounting mechanism is provided for connecting a main lens and a sub-lens. [Figure 6A] A cross-sectional view along line 6-6 in Figure 5, showing two embodiments of the under-surface mounting mechanism. [Figure 6B] A cross-sectional view along line 6-6 in Figure 5, showing two embodiments of the under-surface mounting mechanism. [Figure 7] A front view of a modular IOL according to one embodiment of the present disclosure, in which an extension mounting mechanism is provided for connecting a main lens and a secondary lens. [Figure 8A]Cross-sectional view taken along line 8-8 of FIG. 7 showing three embodiments of an expansion attachment mechanism. [Figure 8B] Cross-sectional view taken along line 8-8 of FIG. 7 showing three embodiments of an expansion attachment mechanism. [Figure 8C] Cross-sectional view taken along line 8-8 of FIG. 7 showing three embodiments of an expansion attachment mechanism. [Figure 9A] Front view showing various positions of an attachment mechanism for adjusting the position of a secondary lens relative to a primary lens. [Figure 9B] Front view showing various positions of an attachment mechanism for adjusting the position of a secondary lens relative to a primary lens. [Figure 9C] Front view showing various positions of an attachment mechanism for adjusting the position of a secondary lens relative to a primary lens. [Figure 9D] Front view showing various positions of an attachment mechanism for adjusting the position of a secondary lens relative to a primary lens. [Figure 10] Front view of a modular IOL according to an embodiment of the present disclosure in which a subsurface attachment mechanism etched for connection between a primary lens and a secondary lens is provided. [Figure 11A] Cross-sectional view of a modular IOL shown in FIG. 10 showing various embodiments of an etched subsurface attachment mechanism. [Figure 11B] Cross-sectional view of a modular IOL shown in FIG. 10 showing various embodiments of an etched subsurface attachment mechanism. [Figure 11C] Cross-sectional view of a modular IOL shown in FIG. 10 showing various embodiments of an etched subsurface attachment mechanism. [Figure 11D] Cross-sectional view of a modular IOL shown in FIG. 10 showing various embodiments of an etched subsurface attachment mechanism. [Figure 11E] Cross-sectional view of a modular IOL shown in FIG. 10 showing various embodiments of an etched subsurface attachment mechanism. [Figure 11F] Cross-sectional view of a modular IOL shown in FIG. 10 showing various embodiments of an etched subsurface attachment mechanism. [Figure 12A]A schematic front view of an alternative modular IOL according to one embodiment of the present disclosure. [Figure 12B] A schematic diagram of a cross-sectional view of an alternative modular IOL according to one embodiment of the present disclosure. [Figure 12C] A schematic diagram of a detail view of an alternative modular IOL according to one embodiment of the present disclosure. [Figure 13A] This figure shows a representative micrograph of a groove (see arrow) formed by laser etching at a magnification of 4X. [Figure 13B] This figure shows a representative micrograph of a groove (see arrow) formed by laser etching at a magnification of 40X. [Figure 14] Various diagrams of alternative modular IOLs according to embodiments of this disclosure. [Figure 14A] A cross-sectional view taken along line AA in Figure 14. [Figure 14B] A cross-sectional view taken along line BB in Figure 14. [Figure 14C] Detailed view of circle C in Figure 14B. [Figure 15] Various diagrams of alternative modular IOLs according to embodiments of this disclosure. [Figure 15A] A cross-sectional view taken along line AA in Figure 15. [Figure 15B] A cross-sectional view taken along line BB in Figure 15. [Figure 15C] Detailed view of circle C in Figure 15B. [Figure 15D] Alternative detail view of circle C in Figure 15B. [Figure 16] Various diagrams of alternative modular IOLs according to embodiments of this disclosure. [Figure 16A] A cross-sectional view taken along line AA in Figure 16. [Figure 16B] A cross-sectional view taken along line BB in Figure 16. [Figure 16C] Detailed view of circle C in Figure 16B. [Figure 16D] Detailed view of circle D in Figure 16A. [Figure 17] Various diagrams of alternative modular IOLs according to embodiments of this disclosure. [Figure 17A] A cross-sectional view taken along line AA in Figure 17. [Figure 17B] Detailed view of circle B in Figure 17A. [Figure 17C] Isometric view of assembled components. [Figure 18] Various diagrams of alternative modular IOLs according to embodiments of this disclosure. [Figure 18A] A cross-sectional view taken along line AA in Figure 18. [Figure 18B] Detailed view of circle B in Figure 18A. [Figure 18C] Isometric view of assembled components. [Figure 19] Various diagrams of alternative modular IOLs according to embodiments of this disclosure. [Figure 19A] A cross-sectional view taken along line AA in Figure 19. [Figure 19B] Detailed view of circle B in Figure 19A. [Figure 19C] Isometric views of the assembled and disassembled components. [Figure 19D] Isometric view of the assembled components. [Figure 20] Various diagrams of alternative modular IOLs according to embodiments of this disclosure. [Figure 20A] A cross-sectional view taken along line AA in Figure 20. [Figure 20B] Detailed view of circle B in Figure 20A. [Figure 20C] Isometric views of the assembled and disassembled components. [Figure 20D] Isometric view of the assembled components. [Figure 20E] Side view of the lens. [Figure 20F] Rear view of the rear surface of the lens. [Figure 20G] Detailed view of circle G in Figure 20E. [Figure 20H] Front view of the front surface of the base. [Figure 20I] Detailed view of circle I in Figure 20H. [Figure 21] Various diagrams of alternative modular IOLs according to embodiments of this disclosure. [Figure 21A] A cross-sectional view taken along line AA in Figure 21. [Figure 21B] A cross-sectional view taken along line BB in Figure 21. [Figure 21C] Detailed view of circle C in Figure 21A. [Figure 21D] Detailed view of circle D in Figure 21B. [Figure 21E] Isometric view of assembled components. [Figure 22] Various diagrams of alternative modular IOLs according to embodiments of this disclosure. [Figure 22A] A cross-sectional view taken along line AA in Figure 22. [Figure 22B] A cross-sectional view taken along line BB in Figure 22. [Figure 22C] Detailed view of circle C in Figure 22A. [Figure 22D] Detailed view of circle D in Figure 22B. [Figure 23A] A schematic diagram of a lens removal system for a modular IOL according to one embodiment of the present disclosure. [Figure 23B] A schematic diagram of a lens removal system for a modular IOL according to one embodiment of the present disclosure. [Figure 23C] A schematic diagram of a lens removal system for a modular IOL according to one embodiment of the present disclosure. [Figure 23D] A schematic diagram of a lens removal system for a modular IOL according to one embodiment of the present disclosure. [Figure 24] This is a schematic flowchart of a method for using a modular IOL according to one embodiment of the present disclosure, in which the replacement of the secondary lens is motivated by intraoperatively detected suboptimal optical results. [Figure 25] This is a schematic flowchart of a method for using a modular IOL according to one embodiment of the present disclosure, in which the replacement of the secondary lens is motivated by postoperatively detected suboptimal optical results. [Figure 26] A schematic flowchart of a method for using a modular IOL according to one embodiment of the present disclosure, in which a secondary lens is attached to a primary lens by forming a mounting means in situ within the body. [Figure 27]Various diagrams of further embodiments of the modular IOL according to this disclosure. [Figure 27A] A cross-sectional view taken along line AA in Figure 27. [Figure 27B] A cross-sectional view taken along line BB in Figure 27. [Figure 27C] Detailed view of circle C in Figure 27A. [Figure 27D] Detailed view of circle D in Figure 27B. [Modes for carrying out the invention]

[0016] Regarding Figure 1, a human eye 10 is shown in cross-section. The eye 10 has been described as an organ that responds to light for several purposes. The eye enables vision as a conscious sense organ. Rod and cone cells in the retina 24 enable conscious light perception and vision, including color discrimination and depth perception. In addition, non-image-forming photosensitive ganglion cells in the human eye's retina 24 receive light signals that influence pupil size regulation, regulation and suppression of the hormone melatonin, and synchronization of the body clock.

[0017] The eye 10 is not strictly a sphere but rather a fused two-piece unit. The smaller, more curved anterior unit, called the cornea 12, is connected to a larger unit called the sclera 14. The corneal region 12 typically has a radius of about 8 mm (0.3 inches). The sclera 14 includes the remaining 5 / 6, and its radius is typically about 12 mm. The cornea 12 and sclera 14 are connected by a ring called the rim. Due to the transparency of the cornea 12, the iris 16, which is the color of the eye, and its black center, the pupil, are visible instead. Light is not reflected, so an ophthalmoscope is needed to see inside the eye 10. The fundus (the region opposite the pupil), including the plaque 28, shows a characteristic pale optic disc (papilla) through which blood vessels entering the eye pass and optic nerve fibers 18 exit the eyeball.

[0018] Therefore, the eye 10 consists of three layers containing three transparent structures. The outermost layer consists of the cornea 12 and the sclera 14. The middle layer consists of the choroid 20, the ciliary body 22, and the iris 16. The innermost layer is the retina 24, which receives its circulation from the blood vessels of the choroid 20 and the retinal blood vessels. This can be seen in an ophthalmoscope. Within these layers are the aqueous humor, the vitreous humor 26, and the soft lens 30. The aqueous humor is a transparent fluid contained in two parts: the anterior chamber between the cornea 12, the iris 16, and the exposed part of the lens 30, and the posterior chamber between the iris 16 and the lens 30. The lens 30 is suspended from the ciliary body 22 by ciliary bodies 32 (Zinn's corpuscles) which consist of fine, transparent fibers. The vitreous humor 26 is a transparent jelly considerably larger than the aqueous humor.

[0019] The crystalline lens 30 is a transparent, biconvex structure of the eye that, together with the cornea 12, refracts light that converges on the retina 24. By changing its shape, the lens 30 functions to change the focal length of the eye, allowing it to focus on objects at various distances, thus enabling the formation of a sharp real image of an object on the retina 24. This adjustment of the lens 30 is known as accommodation and is similar to the focusing mechanism of a photographic camera, which relies on the movement of its lens.

[0020] 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 make up most of the interior of the lens. The cells of the lens epithelium, located between the outermost layer of the lens capsule and lens fibers, are mainly found on the anterior side of the lens, but extend to the posterior side just beyond the equator.

[0021] The lens capsule, which completely surrounds the lens, is a smooth, transparent basement membrane. The capsule is elastic and composed of collagen. It is synthesized by the lens epithelium, and its main components are type IV collagen and glycosaminoglycans (GAGs). Because the capsule is highly elastic, the lens becomes more spherical when not under the tension of the zonular fibers connecting the capsule to the ciliary body 22. The thickness of the capsule varies from approximately 2 to 28 micrometers, being thickest near the equator and thinnest near the posterior pole. The lens capsule may have a higher curvature than the posterior portion of the lens.

[0022] Various diseases and disorders of the lens 30 can be treated with an IOL. For example, but not limited to, a modular IOL according to an embodiment of the present disclosure may be used to treat cataracts, large optical errors in myopic (myopia), hyperopic (hyperopia), and astigmatic eyes, vitreous transposition, aphakia, pseudophakia, and nuclear sclerosis. However, for illustrative purposes, an embodiment of the modular IOL of the present disclosure will be described in relation to cataracts.

[0023] The following detailed description describes various embodiments of a modular IOL system including primary and secondary intraocular components, i.e., an intraocular base configured to removably receive an intraocular lens. In some embodiments, the base may be configured to provide optical correction, in which case the modular IOL system may be described as including a primary lens and a secondary lens. Principles and features described with reference to embodiments in which the base is configured for optical correction may be applied to embodiments in which the base is not configured for optical correction, and vice versa. More broadly, features described with reference to any one embodiment may be applied to and incorporated into other embodiments.

[0024] Figures 2A and 2B show a modular IOL system 50 / 60 implanted in the lens capsule 34 of a lens 30 having a capsular incision 36. The modular IOL system may include a main lens 50 and a secondary lens 60. The main lens 50 may include a body portion 52, a pair of support portions 54 for fixing and centrally positioning the main lens 50 within the lens capsule 34, and means for attaching it to the secondary lens 60 (not shown here, but described later). The secondary lens 60 may include an optical body portion 62 and corresponding means for attaching it to the main lens 50 (not shown here, but described later), and may not include support portions. The front surface of the body portion 52 of the main lens 50 may be in close contact with the posterior surface of the body portion 62 of the secondary lens 60 without any intervening material (e.g., adhesive, aqueous humor, tissue grafting, etc.). For example, the front surface of the body portion 52 may be in direct contact with the posterior surface of the body portion 62. While the main lens 50 remains within the lens capsule 34 of the crystalline lens 30, the secondary lens 60 may be attached to the main lens 50 in a way that allows for acute and long-term detachment to facilitate the replacement of the secondary lens 60.

[0025] The main body 52 of the primary lens 50 may provide some refractive correction, but not enough to achieve the optimal optical result. The optimal optical result may be provided by a combination of corrections provided by the optical body 52 of the primary lens 50 and the optical body 62 of the secondary lens 60. For example, the optical body 62 of the secondary lens 60 may vary (e.g., add or subtract) the refractive power (for single-focus correction), toric function (for astigmatism correction), and / or diffractive function (for multi-focus correction).

[0026] The secondary lens 60 may have an outer diameter d1, the capsulotomy 36 may have an inner diameter d2, and the body 52 of the primary lens 50 may have an outer diameter d3, where d1 < d2 ≦ d3. This arrangement provides a gap between the secondary lens 60 and the periphery of the capsulotomy 36 such that the secondary lens 60 can be attached to or removed from the primary lens 50 without touching or disturbing any part of the lens capsule 34. By way of non-limiting example, assuming the capsulotomy has a diameter of about 5 - 6 mm, the body of the primary lens (i.e., excluding the support portion) may have a diameter of about 5 - 8 mm and the secondary lens may have a diameter of less than about 3 - 5 mm, thereby providing a radial gap of about 1.5 mm or less between the secondary lens and the periphery of the capsulotomy. Regardless of this example, any suitable dimensions may be selected to provide a gap between the secondary lens and the periphery of the capsulotomy to reduce the need to manipulate the lens capsule in attaching the secondary lens to the primary lens.

[0027] Referencing Figures 3A-3D (front view) and 4A-4D (lateral section view), the method for implanting the modular IOL system 50 / 60 is schematically illustrated. As seen in Figures 3A and 4A, the cataract lens 30 contains an opaque or cloudy central portion 38 within the lens capsule 34. Access to the lens 30 for cataract surgery may be provided by one or more lateral incisions in the cornea. A capsulotomy (circular opening) 36 may be formed in the anterior lens capsule 34 using manual tools or a femtosecond laser. As seen in Figures 3B and 4B, the opaque central portion 38 is removed by phacoemulsification and / or aspiration through the capsulotomy 36. The primary lens 50 is delivered in a rolled form using a tube inserted into the lens capsule 34 through the capsulotomy 36. The primary lens 50 is made available to be removed from the delivery tube and unfolded. Through careful handling, the support portion 54 of the primary lens engages with the internal equator of the lens capsule 34, centering the lens body 52 relative to the capsulotomy 36, as seen in Figures 3C and 4C. The secondary lens 60 is delivered in a rolled form using a tube, with its distal tip positioned near the primary lens 50. The secondary lens 60 is made available to be removed from the delivery tube and unfolded. Through careful handling, the secondary lens 60 is centered relative to the capsulotomy 36. Without manipulating the lens capsule 34 or the primary lens 50, the secondary lens 60 is then attached to the primary lens 50, as seen in Figures 3D and 4D. If necessary, the secondary lens 60 may be removed and / or replaced in a similar manner by reversing the steps as appropriate. Alternatively, the primary lens 50 and secondary lens 60 may be implanted as a unit, thus eliminating the delivery step.

[0028] Since it can be difficult to determine which side of the secondary lens 60 should face the primary lens 50, the secondary lens may include markings to indicate its correct position. For example, a clockwise arrow may be placed around the front surface of the secondary lens 60, appearing as a clockwise arrow when the correct side is facing up and as a counterclockwise arrow when the incorrect side is facing up. Alternatively, two-layered color markings may be placed around the front surface of the secondary lens 60, appearing as a first color when the correct side is facing up and as a second color when the incorrect side is facing down. Other positional markings may be used on the secondary lens 60, and similar marking methods may be applied to the primary lens 50.

[0029] With respect to Figure 5, a subsurface mounting mechanism 70 may be used to detachably secure the secondary lens 60 to the primary lens 50. The mounting mechanism 70 may be positioned radially inward around the capsulotomy 36 and radially outward from the field of view to avoid interference with light transmission. Alternatively or in addition, the mounting mechanism 70 may have radial and lateral ranges limited to a small percentage (e.g., less than 10-20%) around the secondary lens 50 to minimize the possibility of interference with light transmission. Although two mounting mechanisms 70 facing each other in the diametrically opposed direction are shown, any suitable number distributed evenly or unevenly around the periphery of the secondary lens 60 may be used.

[0030] When the main lens 50 and the secondary lens 60 are delivered simultaneously, it may be desirable to align the mounting mechanism 70 with the roll axis 80, and the lenses 50 and 60 may be wound around it for insertion by a delivery tool. Since the secondary lens 60 may move relative to the main lens 50 when wound around the axis 80, providing the mounting mechanism 70 along the roll axis 80 minimizes stress on the mounting mechanism 70. For this reason, the mounting mechanism 70 may be aligned coaxially with the roll axis 80 and may be configured to extend a limited distance from the axis 80 (e.g., less than 10-20% of the circumference of the secondary lens 60).

[0031] The mounting mechanism 70 may be configured to have a mating or interlocking structure, as shown in Figures 6A and 6B. Generally, the structure includes a male and female part that can be detachably connected. The female part is configured to receive the male part and restricts relative movement between the main lens 50 and the sub-lens 60 in at least two dimensions (e.g., up and down and left and right). The female and male parts may be configured to have an interlocking structure so as to restrict relative movement between the main lens 50 and the sub-lens 60 in three dimensions (e.g., up and down, left and right, and front and back). The mounting mechanism 70 may be engaged and disengaged by applying orthogonal forces in the rear (pushing) and front (pulling) directions, respectively. The mounting mechanism 70 may be pre-formed, for example, by molding, cutting, etching, or a combination thereof.

[0032] In the examples shown, each mounting mechanism 70 includes a meshing cylindrical projection 72 and a cylindrical recess or groove 74. Other fitting or meshing structures may also be used. The cylindrical structures shown have the advantage of further reducing stress because they allow for a slight rotation of the secondary lens 60 relative to the main lens 50 when wound for delivery. As shown in Figure 6A, the cylindrical projection 72 may extend forward from the front surface of the body 52 of the main lens 50, and the cylindrical recess 74 may extend forward into the rear surface of the body 62 of the secondary lens 60 near its radial peripheral region. Alternatively, as shown in Figure 6B, the cylindrical projection 72 may extend rearward from the rear surface of the body 62 of the secondary lens 60 near its radial peripheral region, and the cylindrical recess 74 may extend rearward into the front surface of the body 52 of the main lens 50. The configuration shown in Figure 6B may be particularly preferred when the main lens 50 is an existing implanted IOL whose recess 74 can be etched in situ within the body, for example, by a laser.

[0033] With respect to Figure 7, an extension mounting mechanism 90 may be used to detachably connect the main lens 50 and the sub-lens 60. The extension mounting mechanism 90 may be similar to the subsurface mounting mechanism 70, except as shown and described. The extension mounting mechanism 90 may extend radially from the periphery of the sub-lens 60, each including a fitting or interlocking structure. Examples are shown in Figures 8A-8C. In Figure 8A, a cylindrical portion 92 extends from the outer edge of the sub-lens 60, and a cylindrical recess 94 extends from the outer edge of the main lens 50. In Figure 8B, a system is shown in which the cylindrical portion 92 extends from the outer edge of the main lens 50, and the cylindrical recess 94 extends from the outer edge of the sub-lens 60. In both embodiments shown in Figures 8A and 8B, the mounting mechanism 90 may be engaged and disengaged by applying orthogonal forces in the rear (pushing) and front (pulling) directions, respectively. Alternatively, in the embodiment shown in Figure 8C, the mounting mechanism 90 may be engaged and disengaged by applying a rotational force in a clockwise or counterclockwise direction, depending on which lens 50 / 60 is mounted to the cylindrical portion 92 and the cylindrical recess 94, respectively. In addition, although the embodiment in Figure 7 shows the use of only two mounting mechanisms 90, any suitable number of mounting mechanisms 90 may be utilized within the principles of this disclosure.

[0034] With respect to Figures 9A-9D, the portion of the mounting mechanism 90 associated with the secondary lens 60 may be positioned so that the center of the secondary lens 60 aligns with the center of the primary lens 50. Alternatively, to compensate for misalignment of the primary lens 50 due to unbalanced postoperative healing, the portion of the mounting mechanism 90 associated with the secondary lens 60 may be offset, for example, as shown in Figures 9B-9D. In Figure 9B, the portion of the mounting mechanism 90 associated with the secondary lens 60 is rotatably offset. In Figure 9C, the portion of the mounting mechanism 90 associated with the secondary lens 60 is offset upward. In Figure 9D, the portion of the mounting mechanism 90 associated with the secondary lens 60 is offset laterally. Front-back offsets may also be used, as will be described in more detail with reference to Figures 11C and 11F. Each of the embodiments shown in Figures 9B, 9C, 9D, 11C, and 11F is provided as an example, and the offset may be of varying magnitudes depending on the misalignment of the primary lens 50 in any direction (front, back, up, down, right, left, clockwise, counterclockwise) or a combination thereof. In addition, although the mounting mechanism 90 is shown as an example, the same principle may be applied to other mounting means described herein.

[0035] With respect to Figure 10, an alternative subsurface mounting mechanism 100 may be used for detachably connecting the sub-lens 50 to the main lens 60. The subsurface mounting mechanism 100 may be similar to the subsurface mounting mechanism 70, except as shown and described. The subsurface mounting mechanism 100 may include a fitting or interlocking structure extending along an arc-shaped path near the peripheral edge of the sub-lens 60. The subsurface mounting mechanism 100 may include a projection 102 and a corresponding recess or groove 104 which may receive the projection 102. The projection 102 may extend from the rear surface of the sub-lens 60, and the corresponding recess or groove 104 may extend into the front surface of the main lens 50, as shown in Figures 11A (separated) and 11D (mounted). Alternatively, the projection 102 may extend from the front surface of the main lens 50, and the corresponding recess or groove 104 may extend into the rear surface of the secondary lens 60, as shown in Figures 11B (separated) and 11E (mounted). In either embodiment, the front-to-rear dimensions of the projection 102 may coincide with a recess or groove 104 of the same dimensions to provide close contact between the front surface of the main lens 50 and the rear surface of the secondary lens 60. Alternatively, as shown in Figures 11C (separated) and 11F (mounted), the front-to-rear dimensions of the projection 102 may extend beyond a recess or groove 104 of the same dimensions to provide a front-to-rear offset. Furthermore, those skilled in the art will readily understand that any number of suitable mounting mechanisms 100 may be utilized within the principles of this disclosure.

[0036] With respect to Figure 12A, an alternative subsurface mounting mechanism 105 may be used to connect the sub-lens 60 to the main lens 50. The subsurface mounting mechanism 105 may be similar to the subsurface mounting mechanism 100, except as shown and described. As seen in Figure 12B, a cross-sectional view taken along line BB in Figure 12A, the subsurface mounting mechanism 105 may include a mating or interlocking structure comprising a projection 107 and a series of holes 109 that may receive the projection 107. The holes 109 may be distributed in a pattern as seen in Figure 12C, which shows some alternative detail views of box C in Figure 12A. In Figure 12C, the projection 107 is located in the holes 109, indicated as black circles, while the remaining holes 109, indicated as white circles, are left empty. This arrangement allows the projection 107 to be positioned in the corresponding pair of holes 109, enabling the desired alignment between the main lens 50 and the sub-lens 60. For example, continuing to refer to Figure 12C, the projections 107 may be positioned in a corresponding pair of holes 109 to achieve central (nominal), rightward, leftward, upward, downward, clockwise, or counterclockwise alignment (labeled C1 to C7, respectively) between the main lens 50 and the secondary lens 60. This arrangement provides various adjustments as described with respect to Figures 9A to 9D. In addition, any suitable number of mounting mechanisms 105 may be evenly or unevenly arranged around the lenses 50 and 60.

[0037] All or some of the various subsurface mounting means described herein may be formed by molding, cutting, milling, etching, or a combination thereof. For example, particularly with respect to Figure 11A, the groove 104 may be formed by laser etching an existing implanted main lens 50 in situ within a living organism, and the protrusions may be pre-formed by molding, milling, or cutting the secondary lens 60.

[0038] Examples of lasers that may be used for in-situ etching in vivo include femtosecond lasers, titanium-sapphire lasers, diode lasers, YAG lasers, argon lasers, and other lasers in the visible, infrared, and ultraviolet regions. Such lasers may be controlled in terms of energy output, spatial control, and temporal control to achieve desired etched structures and patterns. For example, in-situ etching may be achieved by transmitting a laser beam from an external laser source through the cornea and beyond the pupil. Alternatively, in-situ etching may be achieved by transmitting a laser beam from a flexible optical fiber probe inserted into the eye.

[0039] Regarding Figures 13A and 13B, the 4X and 40X magnification microscope images respectively show how grooves (see arrows) were experimentally etched within the main lens by laser etching. To etch the grooves, a femtosecond laser setting within the following range may be used: output power of 1 nJ to 100 μJ, pulse duration of 20 fs to picoseconds or less, and frequency of 1 to 250 kHz.

[0040] The primary and secondary components of the modular IOL systems disclosed herein may be formed from the same, similar, or different materials. Suitable materials may include, for example, acrylic-based materials, silicone materials, hydrophobic polymers, or hydrophilic polymers, and such materials may have shape memory properties. For example, the materials included in the optical portion of a modular lens system may be silicone, PMMA (polymethyl methacrylate), hydrogel, hydrophobic acrylic, hydrophilic acrylic, or other transparent materials commonly used in intraocular lenses. The non-optical components of a modular IOL may include nitinol, polyethylene sulfone, and / or polyimide.

[0041] The materials may be selected to support the specific functions of the modular lens system, particularly the attachment and removal capabilities required for the primary and secondary lenses, as described above. Other functions of modular lenses that can be enhanced by specific material selection include manufacturability, intraoperative and postoperative handling, fixation (both intraoperative and during postoperative revision), the size of the microincision achieved (≤2.4 mm), and interchangeability (minimal trauma during lens explantation).

[0042] For example, in one embodiment, the main and sub-lenses are made from a hydrophobic acrylic material having a glass transition temperature of about 5 to 30°C and a refractive index of about 1.41 to 1.60. In another embodiment, the main and sub-lenses may be made from different materials having different glass transition temperatures and mechanical properties to assist in the fixation and separation characteristics of the modular system. In yet another embodiment, both or either of the modular lens systems are made from a material that allows for compression to an outer diameter equal to or smaller than about 2.4 mm.

[0043] In modular IOL systems, generally desirable material properties include minimal or no photobleaching, minimal puncture when exposed to YAG laser light, and passing standard MEM elution tests and other biocompatibility tests according to industry standards. Materials may contain various chromophores to enhance the substrate's UV blocking capability. Generally, wavelengths below 400 nm are blocked by standard chromophores with a concentration of ≤1%. Alternatively or in addition, materials may contain blue light blocking chromophores, such as yellow dyes, to block a desired region of the blue light spectrum. Suitable materials are generally resistant to damage such as surface abrasion, cracking, or clouding caused by mechanical trauma under standard implantation procedures.

[0044] The components of the modular IOL may be formed by conventional techniques such as molding, cutting, milling, etching, or a combination thereof. As an alternative to mechanical mounting, chemical attraction may be utilized between the main and secondary components. The use of similar materials with a smooth surface finish may promote chemical attraction. Chemical attraction may be enhanced by surface activation techniques such as plasma or chemical activation. In some cases, it may be desirable to reduce chemical attraction to avoid adhesion between materials and to rely more on mechanical mounting for stability. In this case, the main and secondary components may be formed of different materials, or they may have adjacent surfaces that would otherwise not exhibit chemical attraction.

[0045] With respect to Figures 14-14C, alternative modular IOLs 140 are shown in front view, cross-sectional view, and detail view, respectively. Figure 14A shows a cross-sectional view cut along line AA in Figure 14, Figure 14B shows a cross-sectional view cut along line BB in Figure 14, and Figure 14C shows a detail view of circle C in Figure 14B. The modular IOL 140 may include a main lens 50 with a support 54 and a secondary lens 60. As is best seen in Figures 14A and 14B, the interface between the main lens 50 (front surface) and the interface between the secondary lens 60 (rear surface) may be in close contact. Maintaining close contact (i.e., avoiding gaps) or a certain gap between the interface of the main lens 50 and the interface of the secondary lens 60 may reduce the likelihood of astigmatism being induced. However, in some embodiments, a substance (e.g., adhesive) may be placed between the respective surfaces of the lenses 50 and 60. A circular extension may be formed on the secondary lens 60, and a circular recess of similar size and shape may be formed on the main lens 50 to form an interlocking fit between them, thus securely connecting the two components. The depth of the recess in the main lens 50 may be part of the thickness of the secondary lens 60, and the circular extension of the secondary lens 60 extends over a portion of the main lens 50, thereby forming an overlapping joint 142, as best seen in Figure 14C. The overlapping joint 142 may extend 360 degrees or part thereof around the periphery of the secondary lens 60, as shown. The circular extension of the secondary lens 60 protrudes beyond the front surface of the main lens 50, forming a raised portion. In some embodiments, the raised portion may have a configuration that tapers radially. The raised portion may be compressed radially with forceps to facilitate connection and separation of the main lens 50 and the secondary lens 60. Using radial compression to insert the secondary lens 60 into the primary lens 50 reduces the anterior-posterior forces applied to the lens capsule during insertion, thereby reducing the risk of capsule rupture.

[0046] Regarding Figures 15-15D, alternative modular IOL 150s are shown in front view, section view, and detail view, respectively. Figure 15A shows a section view cut along line AA in Figure 15, Figure 15B shows a section view cut along line BB in Figure 15, Figure 15C shows a detail view of circle C in Figure 15B, and Figure 15D shows an alternative detail view of circle C in Figure 15B. The modular IOL 150 may include a main lens 50 with a support 54 and a secondary lens 60. As is best seen in Figures 15A and 15B, the interface between the main lens 50 (front surface) and the interface between the secondary lens 60 (rear surface) may be in close contact. The main lens 50 may include a recess defining a wall, in which a circular secondary lens 60 of similar size and shape may be placed. The wall defined by the recess in the main lens 50 may extend around the entire circumference of the main lens, except for two diametrically opposed gaps 152. The gap 152 thus exposes the peripheral edge of the secondary lens 60, as seen in Figure 15A, to facilitate insertion and removal, for example, by radial compression using forceps for the secondary lens 60. The remainder of the wall defined by the recess of the main lens provides a flush joint, as seen in Figures 15B and 15C, and the front surface of the secondary lens 60 may be flush with the front surface of the main lens 50. As seen in Figure 15C, the wall defined by the recess in the main lens 50 and the interfacing edge of the secondary lens 60 may be inclined inward to provide a joint 154 with secure mechanical engagement and stable connection between them. Alternatively, as seen in Figure 15D, the wall defined by the recess in the main lens 50 and the interfacing edge of the secondary lens 60 may be "S" shaped to provide a joint 156 with secure mechanical engagement and stable connection between them. Another interfacing structure may be used.

[0047] With respect to Figures 16-16D, alternative modular IOL 160s are shown in front view, section view, and detail view, respectively. Figure 16A shows a section view cut along line AA in Figure 16, Figure 16B shows a section view cut along line BB in Figure 16, Figure 16C shows a detail view of circle C in Figure 16B, and Figure 16D shows a detail view of circle D in Figure 16A. The modular IOL 160 may be configured similarly to the modular IOL 150 shown in Figures 15-15D, where the main lens 50 includes a recess defining a wall, and a circular sub-lens 60 of similar size and shape is disposed therein. However, in this embodiment, an angled gap 162 (rather than a gap 152) is provided along a portion of the periphery of the sub-lens 60. The wall defined by the circumferential portion of the peripheral edge of the sub-lens 60 may have the same structure as the wall defined by the recess in the main lens 50 to provide a flush joint 154, which is best seen in Figure 16C. The wall defined by another (e.g., the remaining) circumferential portion of the peripheral edge of the sub-lens 60 may have a structure that angles more inward to provide an angled gap 162, which is best seen in Figure 16D. The angled gap 162 thus exposes the peripheral edge of the sub-lens 60, as seen in Figure 16D, where forceps may be positioned to facilitate insertion and removal by radial compression of the sub-lens 60. Another gap structure may be used.

[0048] With respect to Figures 17-17C, alternative modular IOL 170 are shown in front view, section view, detail view, and isometric view, respectively. Figure 17A shows a section view cut along line AA in Figure 17, Figure 17B shows a detail view of circle B in Figure 17A, and Figure 17C shows an isometric view of an assembled component. The modular IOL 170 may be configured similarly to the modular IOL 150 shown in Figures 15-15D, where the main lens 50 includes a recess defining a wall, in which a circular sub-lens 60 of similar size and shape may be disposed. However, in this embodiment, the wall defining the recess in the main lens 50 includes a milled-down portion to define two diametrically opposed tabs 172. The inner peripheral walls of the tabs 172 provide a flush joint 174, as seen in Figure 17B, such that the front surface of the sub-lens 60 is flush with the front surface of the main lens 50. The interface of the joint 174 along the tab 172 may be, for example, inclined, S-shaped, or C-shaped as shown. In another location along the periphery away from the tab 172, in a region where the wall has been scraped, the peripheral edge of the sub-lens 60 is exposed as shown in Figure 17C to facilitate insertion and removal of the sub-lens 60 by radial compression using forceps, for example.

[0049] With respect to Figures 18-18C, alternative modular IOL180 are shown in front view, section view, detail view, and isometric view, respectively. Figure 18A shows a section view cut along line AA in Figure 18, Figure 18B shows a detail view of circle B in Figure 18A, and Figure 18C shows an isometric view of an assembled component. The modular IOL180 may be configured similarly to the modular IOL170 shown in Figures 17-17C, where the main lens 50 includes a recess defining a partial wall, and a circular sub-lens 60 of similar size and shape is positioned therein, meshing with a tab 172 by a flush joint 174. However, in this embodiment, gripping recesses or holes 182 are provided in each tab 172 and in adjacent portions of the sub-lens 60. In one embodiment, the gripping recesses or holes 182 do not have to penetrate the entire thickness of the main lens 50 and the sub-lens 60. The gripping holes 182 of the auxiliary lens 60 facilitate insertion and removal of the auxiliary lens 60 by radial compression using forceps, for example. The tab portion 172 and the adjacent gripping holes 182 in the auxiliary lens 60 may be pulled together or pushed apart radially to facilitate connection and separation of the joint portion 174, for example, using forceps.

[0050] Using radial force applied through the gripping hole 182 to connect and disconnect (or lock and unlock) the joint 174 between the main lens 50 and the secondary lens 60 reduces the anterior-posterior force applied to the lens capsule, thereby reducing the risk of capsule rupture. The gripping hole 182 may also be used to facilitate the connection and disconnection of different interlocking structures while minimizing anterior-posterior forces. For example, a recess in the main lens 50 may include a female thread that engages with a corresponding male thread on the peripheral edge of the secondary lens 60. In this embodiment, forceps inserted into the gripping hole 182 may be used to facilitate the rotation of the secondary lens 60 relative to the main lens 50 in order to screw the main lens 50 and the secondary lens 60 together and to loosen the screws. In an alternative embodiment, the keyed extension of the secondary lens 60 may be inserted into the keyed opening of the main lens 50 and rotated using forceps inserted into the gripping hole 182 to lock and unlock the main lens 50 and the secondary lens 60 together. In another alternative embodiment, forceps or the like may be inserted rearward through a hole in the secondary lens 60 to grasp a front projection of the main lens 50, such as a handle (not shown), and then rearward pressure may be applied to the secondary lens 60 while holding the main lens 50 stationary. The gripping hole 182 may also be used to rotate the secondary lens 60 relative to the main lens 50, for example, for rotational adjustment in toric applications.

[0051] With respect to Figures 19-19D, alternative modular IOL190 are shown in front view, section view, detail view, isometric exploded view, and isometric assembled view, respectively. Figure 19A shows a section view cut along line AA in Figure 19, Figure 19B shows a detail view of circle B in Figure 19A, Figure 19C shows an isometric exploded assembled view of the components, and Figure 19D shows an isometric assembled view of the components. The modular IOL190 differs from some of the embodiments described above in that the main components function as a base 55 but do not necessarily provide optical correction, while the secondary components function as lenses 65 and provide optical correction. The base 55 may be configured in the shape of an annular or ring having a central opening 57 extending in the front-to-back direction. In some embodiments, the base 55 does not have to define a complete ring or annular shape. The base 55 may also include a support 59 which has a function similar to the support 54 described above but a different geometric configuration. Generally, the support portion 54 / 59 functions to centrally position the base portion 55 within the lens capsule. Such support portions may also be configured to apply outward tension to the inner equatorial surface of the lens capsule to assist symmetrical healing and maintain the centralization of the base, similar to a lens capsule expansion ring. The support portion 59 may include one or more openings therein.

[0052] Since the base 55 includes a central opening 57, the rear optical surface of the lens 65 does not contact the base 55. A circular extension may be formed within the lens 65, and a circular recess of similar size and shape may be formed on the base 55 to form an overlapping joint 192 with a projection on the base 55, having interference and / or frictional fitting between them, so that the two components are securely connected. Alternatively, the shape of the overlapping joint 192 may form an inclined angle or an "S" shape as described above, forming an interlock between them. The joint or connection 192 may include a modified surface to reduce light scattering caused by the connection 192. For example, one or both of the interface surfaces of the joint 192 may be partially to totally opaque or matte (i.e., rough) to reduce light scattering caused by the connection 192.

[0053] As is best seen in Figure 19B, the depth of the recess in the base 55 may be the same thickness as the circular extension of the lens 65 so that the front surface of the lens 65 and the front surface of the base 55 are flush. In this arrangement, the rear surface of the lens 65 extends further back than the front surface of the base 55. In some embodiments, however, the front surface of the lens 65 may be positioned relatively higher or lower than the front surface of the base 55. The dimensions of the recess and the corresponding projection of the base 55 may be selected relative to the thickness of the lens 65 so that at least a portion of the rearmost surface of the lens 65 is coplanar with the rearmost surface of the base 55, or at least a portion of the rearmost surface of the lens 65 is behind the rearmost surface of the base 55.

[0054] Similar to previous embodiments, the lens may be replaced with a different lens either intraoperatively or postoperatively. This may be desirable, for example, if the first lens does not provide the desired refractive correction, in which case the first lens may be replaced with a second lens having a different refractive correction without disturbing the lens capsule. For example, if the lens 65 does not have the desired optical alignment due to base movement or misalignment, it may be replaced with a different lens having an optical portion manufactured to be offset relative to the base 55. For example, the optical portion of the second lens may be offset in the rotational, lateral and / or axial directions, similar to the embodiments described with respect to Figures 9A-9D. This concept may also apply to other embodiments herein in which a sub-component (e.g., the lens) has limited positional adjustability relative to the main component (e.g., the base).

[0055] The general form of this embodiment comes with many advantages, some of which are described below. For example, since the rear optical surface of the lens 65 is not in contact with the base 55, the possibility of debris being trapped between them is eliminated. Also, for example, since the base 55 includes a central opening 57 without material, the base 55 can be wound to a smaller diameter than the main lens 50 described above to facilitate delivery through a smaller incision in the cornea. Alternatively, the base 55 may have a larger outer diameter and may be wound to the same diameter as the main lens 50. For example, the base lens 55 may have an outer diameter of about 8 mm (excluding the support) and may be wound to the same diameter as the main lens 50, which has an outer diameter of 6 mm. This may allow at least a portion of the joint between the base 55 and the lens 65 to move radially outward away from the circumferential edge of the capsulotomy, which typically has a diameter of 5-6 mm. Moving at least a portion of the junction between the base 55 and the lens 65 radially outward from the periphery of the capsulotomy can reduce the amount of the junction in the field of view, and thus reduce the possibility of light scattering or optical aberrations (e.g., anomalous photopsia). Of course, regardless of this example, any appropriate dimensions may be selected to provide a gap between the lens 65 and the peripheral edge of the capsulotomy in order to reduce the need to manipulate the lens capsule to connect the lens 65 to the base 55 or to separate the lens 65 from the base 55.

[0056] With respect to Figures 20-20D, alternative modular IOL200 are shown in front view, section view, detail view, isometric exploded view, and isometric assembled view, respectively. Figure 20A shows a section view cut along line AA in Figure 20, Figure 20B shows a detail view of circle B in Figure 20A, Figure 20C shows an isometric exploded assembled view of the components, and Figure 20D shows an isometric assembled view of the components. The modular IOL200 includes a base 55 with a corresponding support 59 and a lens 65. The base 55 includes a central hole 57 so that the rear optical surface of the lens 65 does not come into contact with the base 55. The lens 65 includes a circular extension of a size and shape to fit into a circular recess formed in the base 55 to form an overlapping joint 202 with a projection on the base 55. The overlapping joint 202 may be configured by an "S" shaped interface to securely connect the two components. Therefore, the modular IOL 200 is similar to the modular IOL 190 except that the joint 202 between the base 55 and the lens 65 may include an arrangement of pegs and holes. In this arrangement, a pair of diametrically opposed pegs 204 may extend rearward from the rear perimeter of the lens 65 and may be fitted into a pair of holes 206 selected from a series of holes 206 formed in the projection of the joint 202 of the base 55.

[0057] Figures 20E–20I show further details of the modular IOL 200. Figure 20E shows a side view of the lens 65, Figure 20F shows a rear view of the rear surface of the lens 65, Figure 20G is a detail view of circle G in Figure 20E, Figure 20H is a front view of the front surface of the base 55, and Figure 20I is a detail view of circle I in Figure 20H. As seen in Figures 20E–20F, a pair of diametrically opposed pegs 204 may extend rearward from the rear perimeter of the lens 65. As seen in Figures 20H–20I, the inner diameter of the base 55 along the projection of the joint 202 may include a series of holes 206 into which a pair of pegs 204 may be inserted. This arrangement may allow the lens 65 to be selectively rotated relative to the base 55, for example, for rotational adjustment purposes in toric applications.

[0058] Regarding Figures 21-21E, alternative modular IOL210s are shown in front view, section view, detail view, and isometric view, respectively. Figures 21A and 21B show section views cut along lines AA and BB of Figure 21, respectively. Figures 21C and 21D show detail views of circle C in Figure 21A and circle D in Figure 21B, respectively. Figure 21E shows an isometric view of the assembled components of the modular IOL210. The modular IOL210 may be configured similarly to a combination of the modular IOL190 shown in Figures 19-19D and the modular IOL170 shown in Figures 17-17C. Similar to the modular IOL190, the modular IOL210 includes a base 55 configured in the shape of an annular or ring with a central opening and a recess defining the wall. A circular lens 65 of similar size and shape may be placed in the recess. Similar to the modular IOL170, the wall defines a recess extending along the inner circumference of the base 55, part of which is machined to define two diametrically opposed tabs 212. The inner peripheral walls of the tabs 212 provide a flush joint 214, as seen in Figure 21C, such that the front surface of the lens 65 is flush with the front surface of the base 55. The interface of the joint 214 along the tabs 212 may be inclined, for example, in an "S" shape or a "C" shape as shown. In another area along the circumference away from the tabs 212, in the region where the wall is machined, the peripheral edge of the lens 65 is exposed, as seen in Figure 21D, to facilitate insertion and removal of the lens 65, for example, by radial compression using forceps.

[0059] Regarding Figures 22-22D, alternative modular IOL220s are shown in front view, cross-sectional view, and detail view, respectively. Figure 22A shows a cross-sectional view cut along line AA in Figure 22, Figure 22B shows a cross-sectional view cut along line BB in Figure 22, Figure 22C shows a detail view of circle C in Figure 22A, and Figure 22D shows a detail view of circle D in Figure 22B. The modular IOL220 includes a base 55 with a corresponding support 59 and a lens 65. The base 55 includes a central hole so that the rear optical surface of the lens 65 does not come into contact with the base 55. The periphery of the lens 65 is sized and shaped to fit a circular recess formed in the base 55 to form a projection on the base 55 and a flush joint 222. The flush joint 222 may be configured by an "S" shaped interface to securely connect the two components. A pair of pegs 224 extend from near the inner circumference of the base 55 toward the front and pass through a pair of arc-shaped slots 226 located near the periphery of the lens 65. As shown in Figure 22, the arc-shaped slots may extend along a portion of the periphery of the lens 65. This arrangement allows the lens 65 to be selectively rotated relative to the base 55, for example, for rotational adjustment purposes in toric applications.

[0060] The peg 224 may be sized and configured to protrude above the anterior surface of the lens 65, as shown in Figure 22C. Forceps or the like may be inserted posteriorly through the arc-shaped slot 226 of the lens 65 to grasp the handle-like peg 224, and then posterior pressure may be applied to the lens 65 while holding the peg 224 stationary. Holding the peg 224 during connection of the lens 65 to the base 55, and thus stabilizing the base 55, reduces the anterior-posterior force applied to the lens capsule, thereby reducing the risk of capsule rupture.

[0061] Figures 23A–23D schematically illustrate a lens removal system for a modular IOL according to one embodiment of the present disclosure. Figures 23A and 23B are a side view and a top view, respectively, of the lens removal system. Figures 23C and 23D are top views showing how the lens removal system may be used to remove the lens 60 / 65. The lens removal or extraction system may include a cannula 230 and a pair of forceps 235. The cannula 230 may include a lumen sized to slidably receive the forceps 235. The cannula 230 may include a tubular shaft portion 232 and an inclined tip opening 234. The cannula 230 may be formed and configured similarly to, for example, a conventional IOL insertion device. The forceps 235 include a pair of non-invasive gripping tips 237 and a tubular shaft 239. The tips 237 may be compressed to advance the tubular shaft 239 to grip the lens 60 / 65. The forceps 235 may be formed and constructed similarly to, for example, conventional ophthalmic forceps, except that the tip 237 may be formed from or coated with a relatively soft polymer material to avoid damage to the lens 60 / 65. In general, any device used to manipulate the modular IOL components described herein may be formed from or coated with a relatively soft polymer material to avoid damage to the components.

[0062] With respect to Figures 23C and 23D, the cannula 230 may be inserted through the corneal incision until its tip is adjacent to the capsulotomy. The forceps 235 may be inserted into and through the cannula 230 until its tip 237 extends distally beyond the tip of the cannula 230. The lens 60 / 65 to be extracted may be grasped by the forceps 235 as shown in Figure 23C. With the lens 60 / 65 securely held by the forceps 235, the forceps 235 may be retracted proximally into the cannula 230. As the forceps 235 is retracted into the cannula 230, the lens 60 / 65 enters the contoured opening 234. The contoured opening 234 facilitates the curling and folding of the edge of the lens 60 / 65, as seen in Figure 23D. By fully retracting the forceps 235 into the cannula 230, the subsequent lens 60 / 65, which can be removed from the eye, is safely captured in the lumen of the cannula 230. A similar technique may also be used to insert the lens 60 / 65 by reversing the related steps.

[0063] Figures 24-26 illustrate exemplary methods of using modular IOLs according to embodiments of the present disclosure. While examples are given with respect to the primary and secondary lenses, the same or similar methods may be applied to other modular IOL embodiments, including modular IOL embodiments described herein that include a base and a crystalline lens.

[0064] With respect to Figure 24, a schematic flowchart shows a method for using a modular IOL according to one embodiment of the present disclosure. In this example, the secondary lens may be replaced if suboptimal optical results are detected intraoperatively. An IOL implantation procedure, such as cataract surgery, may be initiated according to conventional methods 110. Subsequently, the natural lens may be prepared to receive the modular IOL 112 using conventional steps such as creating an incision for corneal access, incising the capsulotomy of the anterior lens capsule, and removing the cataract lens by phacoemulsification. The base lens (i.e., the main lens 50) is then positioned within the lens capsule 114. The secondary lens (i.e., the secondary lens 60) is then positioned on the base lens within the periphery of the capsulotomy without touching or otherwise disturbing the lens capsule 116. Mounting means then engage 118 to detachably connect the secondary lens to the base lens. Alternatively, the secondary lens may be attached to the base lens before being placed in the crystalline lens capsule so that the base lens and secondary lens are inserted together as a unit. With both the base lens and secondary lens in place, the optical results may be measured, for example, by intraoperative aberration measurement 120. The optical results may take into account refractive correction, centrality, toric correction, etc. A determination 122 is then made as to whether the optical results are optimal or not. If the optical results are optimal or otherwise appropriate, the IOL procedure is completed 124. However, if the optical results are not optimal or otherwise inappropriate, the mounting means may be separated 126 and the secondary lens may be removed 128. Different secondary lenses may then be placed on the base lens 116 according to the same subsequent steps as shown. Different secondary lenses may, for example, have different refractive powers to correct refractive errors, different offsets to correct eccentricity, or toric errors (toric It may have different toric powers to correct for errors.

[0065] With respect to Figure 25, an alternative method for using a modular IOL according to one embodiment of the present disclosure is shown in a schematic flowchart. In this example, the secondary lens may be replaced if suboptimal optical results are detected postoperatively. For example, the same steps 110-118 and 124 as described above may be performed, except that the patient has been acclimatized to the modular IOL for 1-4 weeks or longer. At a follow-up visit, the optical results are measured and determined to be optimal or suboptimal. If the optical results are optimal or otherwise appropriate, the procedure is stopped. If the optical results are suboptimal or otherwise inappropriate, a corrective procedure to replace the secondary lens may be initiated according to steps 126, 128, 116, and 118 described above.

[0066] This method allows the lens capsule to heal before determining whether the optical outcome is sufficient, and the healing process may be advantageous in that it alters the position of the primary and / or secondary lenses. This method may also be applied on a chronic basis where the patient's visual needs or requirements change over a longer period (e.g., >1 year). In this example, the patient may need or desire different corrections, such as stronger refractive correction, toric correction, or multifocal correction, each of which may be addressed with a different secondary lens.

[0067] With respect to Figure 26, an alternative method for using a modular IOL according to one embodiment of the present disclosure is shown in a schematic flowchart. In this example, a secondary lens may be implanted in a patient 138 who has an existing IOL that is optically suboptimal or does not meet the patient's needs and requirements. After the start of the procedure 110, for example, a mounting mechanism may be formed in situ within the existing (basal) IOL using laser etching to form a groove as described above (step 140). The groove formation may be performed around a pre-incised capsulotomy to avoid touching or disturbing the lens capsule. The secondary lens may then be positioned 116 on the basal lens around the capsulotomy, and the mounting means may engage 118 to connect the secondary lens to the basal lens, thus completing the procedure 124 as described above.

[0068] Regarding Figures 27-27D, alternative modular IOL270s are shown in front view, section view, and detail view, respectively. Figures 27A and 27B show section views cut along lines AA and BB of Figure 27, respectively. Figures 27C and 27D show detail views of circle C in Figure 27A and circle D in Figure 27B, respectively. The modular IOL270 may be configured similarly to the modular IOL210 shown in Figures 21-21D. Similar to the modular IOL210, the modular IOL270 includes a base 55 configured in the shape of an annular or ring, which comprises a central opening and a recess defining a wall in which a circular lens 65 of similar size and shape may be placed. Also similar to the modular IOL210, the wall defining the recess extends along the inner circumference of the base 55, and a portion thereof is cut to define two diametrically opposed tabs 272. The inner peripheral wall of the tab 272 provides a flush joint 274, as shown in Figure 27C, such that the front surface of the lens 65 is flush with the front surface of the base 55. The interface of the joint 274 along the tab 272 may be inclined, for example, in an "S" shape or a "C" shape as shown. In another location along the periphery away from the tab 272, in a region where the wall has been scraped, the peripheral edge of the lens 65 is exposed, as shown in Figure 27D, to facilitate insertion and removal of the lens 65, for example, by radial compression using forceps.

[0069] Since the base 55 includes a central opening without material, the base 55 has a larger outer optical diameter (excluding the support), for example, about 8 mm, and can be wound into a delivery shape small enough to fit a corneal incision of less than about 2.4 mm. This may allow at least a portion of the junction between the base 55 and the lens 65 to move radially outward away from the circumferential edge of the capsulotomy, which typically has a diameter of 5-6 mm. Moving at least a portion of the junction between the base 55 and the lens 65 radially outward away from the periphery of the capsulotomy can reduce the amount of junction in the field of view, and therefore can reduce the likelihood of light scattering or optical aberrations (e.g., anomalous photopsia).

[0070] To further demonstrate this advantage, consider a standard (single-component) IOL typically having a conventional lens optical diameter of 6 mm. An IOL with a 6 mm diameter optical element can be rolled up and delivered through a 2.2 mm corneal incision. To ensure the standard IOL is securely fixed within the lens capsule, the capsulotomy is usually made large enough to allow the lens capsule to fully capture the standard IOL after the capsule has collapsed and healed. This results in the surgeon creating a capsulotomy with a diameter of approximately 4.5 mm to 5.5 mm.

[0071] Here, for comparison, we consider IOL270. The modular (two-part) nature of IOL270 and the hole in the base 55 allow both components (base 55 and lens 65) to be rolled up and delivered through a small corneal incision (e.g., 2.2 mm) without requiring a 4.5 mm–5.5 mm capsulotomy. Conversely, since the base has a diameter of 8 mm (excluding the support), the capsulotomy diameter may be larger (e.g., 6.0 mm–6.5 mm), which allows the lens 65 to fit comfortably inside the periphery of the capsulotomy and also allows the connector 274 to be further peripheral to further minimize light scattering. Of course, regardless of these examples, any appropriate dimensions may be selected to provide a gap between the lens 65 and the peripheral edge of the capsulotomy to reduce the need to manipulate the lens capsule to connect the lens 65 to the base 55 or to separate the lens 65 from the base 55. (Note) As a preferred embodiment, the technical concept that can be understood from the above embodiment is described below. [Section 1] An intraocular lens system for implantation within a lens capsule having a surrounding capsular incision, a. An intraocular main component having a main body and one or more support parts, wherein the main component is configured to fit into the lens capsule, and the main body has an equatorial circumference that is larger than or equal to the circumference of the capsulotomy, b. An intraocular subcomponent having an optical body having an equatorial circumference smaller than the circumference of the capsulotomy portion, c. The main component is configured to detachably receive and connect the sub-component in order to provide optical correction. system. [Section 2] The system according to item 1, wherein the main component includes a central hole extending in the front-to-back direction, and the hole is sized and configured to receive the sub-component. [Section 3] The system according to item 2, wherein the rearmost optical surface of the subcomponent extends further back than the front surface of the main component. [Section 4] The system according to item 3, wherein at least a portion of the rearmost optical surface of the sub-component lies coplanar with the rearmost surface of the main component. [Section 5] The system according to item 4, wherein at least a portion of the rearmost optical surface of the sub-component is located behind the rearmost surface of the main component. [Section 6] The system according to item 1, wherein the main component and the sub-component are connected at a joint, and at least a portion of the joint includes a modified surface for reducing light scattering caused by the joint. [Section 7] The system according to claim 6, wherein the modified surface is at least partially opaque to reduce light scattering caused by the bonding. [Section 8] The system according to item 6, wherein the modified surface is at least partially matted to reduce light scattering caused by the bonding. [Section 9] The system according to item 1, wherein the main component is a base and the subcomponent is a lens. [Section 10] The system according to item 1, wherein the main component is a main lens and the sub-component is a sub-lens. [Section 11] The system according to paragraph 10, wherein the rear optical surface of the sub-lens is in close contact with the front optical surface of the main component. [Section 12] The system according to item 10, wherein the main lens and the sub-lens, in combination, provide desired optical correction. [Section 13] The system according to item 1, wherein the aforementioned sub-components exclude the support portion. [Section 14] The system according to item 1, wherein the diameter of the equator of the subcomponents is located within the periphery of the capsulotomy and is configured to define a radial gap between them. [Section 15] The system according to item 1, wherein the sub-component is fixed to the main component by a mechanical attachment, and at least a portion of the mechanical attachment is configured to be located within the periphery of the capsulotomy, and the mechanical attachment can be engaged and disengaged by the application of one of an axial force or a rotational force. [Section 16] The system according to claim 15, wherein the mechanical mounting portion includes one of a fitting structure or a meshing structure connected to the main component and the sub-component. [Section 17] The system according to claim 15, wherein the mechanical mounting portion includes two pairs of fitting structures that are diametrically opposed and adjacent to the peripheral edge of the sub-component. [Section 18] The system according to paragraph 17, wherein the fitting structure is aligned with the winding axis, and the components are wound around the winding axis for delivery into the lens capsule. [Section 19] The system according to item 15, wherein the mechanical mounting portion includes a projection and a recess. [Section 20] The system according to paragraph 19, wherein the recess is formed on one of the main component and the subcomponent, and the projection is formed on the other of the main component and the subcomponent. [Section 21] The system according to item 19, wherein the recess is formed in situ within the body. [Section 22] The system according to item 1, wherein the sub-component is fixed to the main component by chemical attraction. [Section 23] The system according to item 22, wherein the contact surface of the main component and the contact surface of the sub-component are formed of the same material. [Section 24] The system according to paragraph 23, wherein the contact surface of the main component and the contact surface of the subcomponent are chemically treated to activate the surface. [Section 25] The system according to item 1, wherein the connection portion of the main component to the sub-component is adjustable in one of the following directions: rotation, lateral (left and right), or axial (front and back). [Section 26] A method for implanting an intraocular lens (IOL), a. A step of preparing the natural lens capsule for IOL implantation, including forming a capsulotomy site, b. The step of placing the main components within the lens capsule, c. The step of fixing the secondary component to the main component within the periphery of the capsulotomy, Methods that include... [Section 27] The method according to paragraph 26, wherein the main component and the sub-component are connected at a periphery-containing joint, and at least a portion of the periphery of the joint is larger than the periphery of the capsulotomy to reduce the possibility of light scattering and abnormal photopsia associated with the joint. [Section 28] The method according to claim 26, further comprising the step of removing the sub-components from the main component without destroying the lens capsule associated with the main component. [Section 29] The method of paragraph 28, further comprising the step of fixing a different sub-component having different optical properties from the main component without destroying the lens capsule associated with the main component. [Section 30] A method for implanting an intraocular lens (IOL), a. A step of forming at least a portion of the mechanical attachment part on an IOL that has been pre-implanted around the capsulotomy site, b. The step of fixing the auxiliary components to the pre-implanted IOL in the vicinity of the capsule incision, Methods that include...

Claims

1. A modular intraocular lens system for implantation inside the eye, (a) An annular base having an inner circumference defining a central hole and an outer circumference having two or more support portions extending outward therefrom, wherein the inner circumference includes a continuous circumferential recess having a projection extending over the entire inner circumference, and the continuous circumferential recess has a front rim and a rear rim, (b) A lens disposed within the continuous circumferential recess on the projection of the annular base, covering the central hole, wherein an overlapping joint is formed between the lens and the annular base, and the joint is configured to allow insertion of the lens into the annular base and removal of the lens from the annular base, Equipped with, (c) The lens has an optical axis and, when positioned within the continuous circumferential recess, has a stationary position along the optical axis with respect to the annular base. (d) A modular intraocular lens system comprising a pair of slots configured to allow a change in the rotational position of the lens relative to the annular base, and a pair of pegs extending from the annular base being positioned within the pair of slots.

2. The modular intraocular lens system according to claim 1, wherein the pair of pegs extend anteriorly from the annular base.

3. The modular intraocular lens system according to claim 2, wherein the pair of pegs are located near the inner circumference of the annular base.

4. The modular intraocular lens system according to claim 1, wherein the pair of pegs are opposite each other in the diametrical direction.

5. The modular intraocular lens system according to claim 1, wherein the pair of pegs comprises a first peg and a second peg, the first peg being positioned apart from the second peg.

6. The modular intraocular lens system according to claim 1, wherein the pair of slots are located near the periphery of the lens.

7. The modular intraocular lens system according to claim 6, wherein the pair of slots are opposite each other in the diametrical direction.

8. The modular intraocular lens system according to claim 1, wherein the pair of slots have an arc shape.

9. The modular intraocular lens system according to claim 1, wherein each of the pair of slots extends along a portion of the periphery of the lens.

10. A modular intraocular lens system for implantation inside the eye, (a) An annular base having an inner circumference defining a central hole and an outer circumference having two or more support portions extending outward therefrom, wherein the inner circumference includes a continuous circumferential recess having a projection extending over the entire inner circumference, the continuous circumferential recess having a front rim and a rear rim, the inner diameter of the front rim being larger than the inner diameter of the rear rim, the annular base having a pair of pegs near the inner circumference, the pair of pegs extending forward from the annular base, (b) A lens having an optical portion and a periphery, wherein the optical portion has an optical axis, the optical portion is positioned to cover the central hole, and the periphery is positioned within the continuous circumferential recess on the projection of the annular base to form an overlapping joint, the joint being configured to allow insertion of the lens into the annular base and removal of the lens from the annular base, and the lens further has a pair of slots near the periphery, Equipped with, (c) When the lens is placed in the continuous circumferential recess, it has a stationary position along the optical axis with respect to the annular base, (d) A modular intraocular lens system comprising the pair of slots and the pair of pegs, configured to allow for changes in the rotational position of the lens relative to the annular base.

11. The modular intraocular lens system according to claim 10, wherein the pair of pegs extend through the pair of slots of the lens.

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