Apparatus for repair and tensioning of the lens capsule

Abstract

Provided herein are devices for repairing the natural lens capsule after cataract surgery. The devices use a substantially annular rigid and flexible assembly to contact the posterior and anterior surfaces of the capsule after cataract surgery to repair the capsule shape. Also provided are devices for tensioning the capsule after cataract surgery. An elastic annular body is shaped to secure the edges of a capsulorhexis in a clamp-like configuration. Alternatively, similar to the rigid and flexible assembly of the capsule repair device, the elastic annular body is formed with a lower assembly depending from the body and a flexible annular body extending from the lower assembly.

Description

[0001] This application is a divisional application of Chinese Patent Application No. 201880015197.2, filed on March 1, 2018, entitled "Device for Repairing and Tensing Lens Capsule".

[0002] Cross-references to related applications

[0003] This international application claims the priority of pending non-provisional application U.S. Serial No. 15 / 446,121, filed March 1, 2017, pursuant to 35 U.S. SC §120, which is incorporated herein by reference in its entirety. Background of the Invention

[0004] Invention Field

[0005] This invention relates to the field of ophthalmology and to surgical devices for performing eye surgeries. More specifically, this invention relates to devices for the precise placement of intraocular lenses for functional and anatomical reconstruction of the human lens capsule and for any surgery requiring lens replacement and alignment.

[0006] Related fields description

[0007] An intraocular lens (IOL) is a plastic lens that has essentially the same optical capabilities as the natural lens to be replaced. Typically, during cataract surgery, an ophthalmologist removes the damaged natural lens and replaces it with an artificial IOL. There are generally three types of IOLs: refractive lenses, diffractive lenses, and refractive-diffractive lenses. A refractive lens focuses light towards a focal point on the optical axis by refraction, while a diffractive lens produces a diffraction pattern that forms a focal point on the optical axis for each diffraction order. A refractive-diffractive lens combines features of both types. However, these purely refractive bifocal or multifocal lenses have some significant drawbacks. First, their effectiveness is highly dependent on pupil size and coaxiality. Second, because they have multiple focal points, the resulting contrast is reduced. This can cause halos, particularly in distance vision, and reduce brightness (see, for example, U.S. Patent No. 8,636,796B2).

[0008] Furthermore, posterior capsule opacification (PCO, or after cataract) remains a common problem after cataract surgery with intraocular lens implantation. PCO typically results from a transition from intracapsular cataract extraction (ICCE) to extracapsular cataract extraction (ECCE), in which the posterior capsule of the lens remains intact during the procedure. Patients with PCO suffer from decreased visual acuity, impaired contrast sensitivity, and glare impairment. Clinically, members of posterior capsule opacification are identified as regenerative or fibrotic members, with regenerative posterior capsule opacification being far more common than fibrotic members.

[0009] Regenerative posterior capsular opacity is caused by residual lens epithelial cells (LECs) (so-called E-cells) from the lens equator, which migrate and proliferate in the space between the posterior capsule and the intraocular lens, forming a layer of lens material and Elschnig pearls. In contrast, fibrotic posterior capsular opacity is caused by LECs from the anterior capsule, which undergo transformation into myofibroblasts and enter the posterior capsule, causing the capsule to become white and wrinkled. This can lead to decentration of the intraocular lens and impair imaging of the peripheral retina. Findl et al. (J CataractRefract Surg 2003; 29(1):106-11) disclosed that both members of posterior capsular opacity lead to decreased visual function when they affect the central area around the visual axis. YAG or Nd lasers used in YAG laser capsulotomy are most commonly used to treat posterior capsular opacity. However, as disclosed in Georgianas et al. (Ther Clin Risk Manag. 2009; 5:133–137), laser capsulotomy can lead to other complications such as retinal detachment or increased intraocular pressure.

[0010] European Patent No. 507292B1 describes the need for a "suppression device" for maintaining the shape of the capsular bag as substantially circular after cataract extraction and for inhibiting problems such as the invasion of degenerated epithelial cells into the posterior capsular bag, and further relates to a suppression device in which the intraocular lens can be kept in good condition by forming a groove in the periphery of the intraocular lens. It describes a stable circular shape of the device for effectively inhibiting capsular contracture without involving the actual diameter of the outer ring.

[0011] US Patent Publication No. 2006 / 0047339A1 describes a device for connecting to the natural lens capsule, enabling the lens capsule to be maintained in a configuration that avoids postoperative changes that are detrimental to vision. An adjustable single or dual optical system is provided. The role of "postoperative contraction" of the empty capsule in causing optical changes and lens displacement that induces astigmatism is emphasized. Therefore, there is a need to provide a device or apparatus and its operation to maintain the shape of the lens capsule and to maintain its diameter (for the capsulotomy opening of the device).

[0012] International application number WO2007044604 A1 describes establishing preoperative anatomical relationships by measuring, for example, the spatial relationships of structures within the eye, such as the distance from the corneal surface to the posterior surface of the lens capsule and from the posterior surface of the cornea or lens capsule to the retina, using techniques such as ultrasound, partial coherence measurement, optical coherence tomography, or laser measurement, or by any other means known in the art. Surgical procedures, such as intraocular lens implantation, are performed, and septal tools are provided to restore those pre-measured spatial relationships or to create a new, predetermined septum. Septal tools may include, for example, septal bodies, rings, expandable structures, or thick or multi-lens lenses. These tools help maintain the normal depth of the anterior and posterior capsules and prevent anterior vitreous movement and retinal detachment that may result from such movement.

[0013] Goldberg (Clin Ophthalmol. 2011; 5:1-7) claimed that the intersecting zonules provide support for the posterior lens and stabilize its shape. In this model, the anterior vitreous zonule inserts into the Wieger's ligament, and the PIZ-LE zonule anchors the lens equator to the posterior insertion zone. The intersecting zonules and the Wieger's ligament maintain lens positioning, while the anterior and posterior zonules provide mutual accommodation and disaccommodation. The Wieger's ligament, representing the mid-peripheral region of the posterior capsule, is the most important area for stabilizing lens position during accommodation.

[0014] U.S. Publication No. 2010 / 0204790A1 describes an intraocular lens device having a ring-shaped fixation platform, which can form a “frame” in which the intraocular lens of the present invention can be connected… and concludes that the discovery of the present invention enables surgical methods for the insertion and subsequent removal and replacement of intraocular lenses with a reduced risk of eye damage or vision loss.

[0015] According to the Market Scope Report (2015 Comprehensive Report on the Global Intraocular Lens Market, June 2015), the high-end intraocular lens (IOL) market will reach 9.3% of global volume and 34% of total global IOL revenue. Multifocal and toric IOLs will dominate the high-end IOL market with nearly 90% market share. Toric and multifocal lenses are highly sensitive to precise coaxiality and intracapsular positioning.

[0016] Several patents and publications, including U.S. Patent Nos. 9,339,375B2, US4710194, U.S. Publication Nos. 2005 / 0085,907, 2005 / 0209692, 2010 / 0204790, 2010 / 0228344, 2011 / 0082543, and European Application No. 037,390A2, disclose various intracapsular rings for different purposes. However, these works describe a ring of a standard size or multiple sizes that lacks any adjustability for adjustment. These devices typically include a ring and an optical system adapted to the ring. Some devices include deformable rings that change shape of the central optical portion under ciliary pressure and simulate adjustment mechanisms.

[0017] Due to the complexity of small-band traction in multifocal and toric intraocular lenses already on the market and expected to improve rapidly in the near future, previous work in the art has not taken into account current accommodation theories and the maintenance of continuous changes in capsule shape. Therefore, the need in the art for devices and methods for capsule repair is recognized. In particular, existing technologies are deficient in devices for achieving precise placement and alignment of intraocular lenses postoperatively. The present invention addresses this long-standing need and expectation in the art. Invention Overview

[0018] This invention relates to a device for repairing the natural lens capsule of the eye after cataract surgery. The device includes an annular rigid assembly. The rigid assembly includes a distal end contacting the anterior surface of the capsule and a proximal end located on the posterior surface of the capsule and abutting the Wieger's ligament in the eye. An annular flexible assembly, substantially concentric with the rigid assembly, is flexibly mounted abutting the inner surface of the capsule. The annular flexible assembly includes a proximal end formed on the outer surface of the proximal end of the rigid assembly and a distal end extending away from the rigid assembly. A groove is provided on the inner surface of the rigid assembly, the groove being configured to receive a haptic on an artificial lens. The invention also relates to a related device further including a protrusion formed from the top of the distal end of the rigid assembly.

[0019] The present invention also relates to a device for flexibly restoring tension to the natural lens capsule after cataract surgery. The device includes an annular rigid assembly comprising a distal end positioned in a support relationship with the anterior surface of the lens capsule, a proximal end positioned in a support relationship with the posterior surface of the lens capsule and adjacent to the Wiegand ligament of the eye, and a projection formed from the top of the distal end of the rigid assembly. An annular flexible assembly, substantially concentric with the rigid assembly, is flexibly mounted against the inner surface of the capsule. The flexible assembly is configured to bend away from the rigid assembly when the ciliary muscle relaxes and the ligaments lesser are taut, and to bend toward the rigid assembly when the ciliary muscle contracts and the ligaments lesser are relaxed. The annular flexible assembly includes a proximal end formed on the outer surface of the proximal end of the rigid assembly, and a distal end extending away from the rigid assembly. A groove is provided on the inner surface of the rigid assembly, the groove being configured to receive a tactile element on the artificial lens. The present invention relates to a related device further comprising a plurality of markers provided on the top surface of the projection, configured to guide the alignment of the toric lens. The present invention relates to another related device, which further includes a plurality of gaps disposed around the circumference of the annular flexible component, configured to improve the flexibility of the annular flexible component.

[0020] The present invention also relates to a system for flexibly restoring tension to the natural lens capsule after cataract surgery. The system includes a device for flexibly restoring tension to the natural lens capsule as described herein, and a resilient annular body having an opening formed therein around the inner circumference of the annular body in a clamping configuration.

[0021] The present invention still relates to a device for tightening the eye capsule after cataract surgery. The device includes an elastic annular body having an upper and lower portion of a clamping structure formed by openings extending into the annular body around its outer perimeter.

[0022] The present invention also relates to a tensioning device for the natural capsule of the eye after cataract surgery. The tensioning device includes an elastic annular body and a flexible annular body, the flexible annular body being substantially concentric with and extending outward from the lower end of a lower assembly. The elastic annular body includes an upper assembly and a lower assembly, the upper assembly having upper and lower body portions separated in a clamp-like configuration by an opening formed therein around its inner circumference, the lower assembly being formed to hang downward from the lower surface of the lower body portion at its upper end. The present invention relates to a related tensioning device in which the lower assembly of the elastic annular body further includes a groove disposed around its inner surface, the groove being configured to receive a tactile element on an intraocular lens.

[0023] Other and additional aspects, features, and advantages of the invention will become apparent from the following description of the presently preferred embodiments. These embodiments are given for the purpose of disclosure. Brief description of the attached diagram

[0024] Therefore, the foregoing features, advantages, and objectives of the invention, as well as other features, advantages, and objectives, which will become clear from the accompanying drawings and can be understood in detail therein, are illustrated in a more specific description and certain embodiments of the invention as briefly summarized above. These drawings form part of the specification. However, it should be noted that the drawings illustrate preferred embodiments of the invention and are therefore not intended to limit its scope.

[0025] Figure 1 The structures of the sac and Wiegand ligament with (left) and without (right) ciliary body contraction are depicted.

[0026] Figure 2 This is a cross-sectional view of the device, showing the flexible components of the device in free form (right) and mounted on the side surface of the sac close to the eye (left).

[0027] Figure 3 It is a cross-sectional view of the device, showing the proximal end of the device positioned within the sac and close to the Wigg ligament.

[0028] Figure 4 It is a cross-sectional view of the device, which shows that the diameter of the front surface of the bladder is larger than the diameter of its rear surface.

[0029] Figure 5 It is a cross-sectional view of the device, showing the placement of the intraocular lens in the device by inserting the tactile component of the intraocular lens into a groove provided on the inner surface of a rigid component.

[0030] Figure 6 This is a cross-sectional view of the device, showing the placement of an asymmetric intraocular lens within it.

[0031] Figure 7It is a cross-sectional view from the side of the device, showing the rigid and flexible components.

[0032] Figure 8 This is a top view of the device, showing multiple markers set on the top surface of the rigid assembly as indicators for alignment of the toric intraocular lens.

[0033] Figure 9 This is a top view of the device, showing multiple gaps arranged along the circumference of the flexible component to enhance its flexibility.

[0034] Figure 10 This is a cross-sectional view of one embodiment of the elastic annular tensioning device.

[0035] Figure 11 yes Figure 2 The cross-sectional view further illustrates the positioning of the elastic annular tensioning device in the cross-section when the edge of the fixed capsulorhexis is fixed.

[0036] Figure 12 This is a cross-sectional view of another embodiment of the tensioning device, showing the placement of the elastic annular body and the flexible annular body relative to the edge of the tear bladder and the bladder. Invention Details

[0037] As used herein, the following terms and phrases shall have the meanings described below. Unless otherwise defined, all technical and scientific terms used herein shall have the same meanings as commonly understood by one of ordinary skill in the art.

[0038] As used herein, the terms "a" or "an" may mean one or more. As used herein, in the claims, when used in conjunction with the word "comprising," the words "a" or "an" may mean one or more. As used herein, "another" or "other" may mean at least a second or more identical or different claim elements or requirements thereof. The terms "comprising" and "including" are used in an inclusive and open-ended sense, meaning that additional elements may be included.

[0039] As used herein, although this disclosure supports only the definition of alternatives and "and / or", the term "or" in the claims means "and / or" unless it is expressly stated that it refers only to alternatives or that the alternatives are mutually exclusive.

[0040] As used herein, whether explicitly stated or not, the term "about" refers to a numerical value, including, for example, integers, fractions, and percentages. The term "about" generally refers to a range of numerical values ​​(e.g., + / - 5 to 10% of the stated value) that a person skilled in the art would consider equivalent (e.g., having the same function or result) to be equivalent to the stated value. In some instances, the term "about" may include a numerical value rounded to the nearest significant figure.

[0041] As used herein, the term "distal" refers to the end distal to the posterior surface of the sac; the term "proximal" refers to the end toward the posterior surface of the sac.

[0042] As used herein, the terms “substantially annular,” “ring-shaped,” and “circular” are interchangeable and refer to the three-dimensional shape of the device described herein, such as being similar to or analogous to a donut.

[0043] In one embodiment of the invention, a device is provided for repairing the natural lens capsule of the eye after cataract surgery, the device comprising: an annular rigid assembly including: a distal end contacting the anterior surface of the capsule, and a proximal end disposed close to the Wiegand ligament in the eye; an annular flexible assembly substantially concentric with the rigid assembly and flexibly mounted close to the inner surface of the capsule, the annular flexible assembly including: a proximal end formed on the outer surface of the proximal end of the rigid assembly, and a distal end extending away from the rigid assembly; and a groove disposed on the inner surface of the rigid assembly, the groove being configured to receive a tactile element on an artificial lens.

[0044] Furthermore, in this embodiment, the device may also include a protrusion formed from the top of the distal end of the rigid component. In this further embodiment, the protrusion may include a plurality of markers disposed on its top surface, configured to guide the alignment of the toric lens. Additionally, in this further embodiment, the protrusion may have a width of approximately 0.1 mm to approximately 1 mm.

[0045] In both embodiments, the proximal end of the rigid component may have a thickness of about 0.2 mm to about 1 mm. Furthermore, the distal end of the rigid component may have a thickness of about 0.1 mm to about 0.5 mm. Additionally, the rigid component may be made of or may contain (but is not limited to) silicone, acrylic, poly(methyl methacrylate), hydrogel, or combinations thereof.

[0046] Furthermore, in both embodiments, the annular rigid component can be substantially perpendicular to the anterior surface of the natural lens capsule. In both embodiments, the annular flexible component can be configured to bend away from the rigid component when the ciliary muscle relaxes and the fasciculus lesser is tense, and to bend toward the rigid component when the ciliary muscle contracts and the fasciculus lesser relaxes.

[0047] Furthermore, in both embodiments, the annular flexible component may include a plurality of gaps disposed around its circumference. Additionally, each gap may have a width of approximately 0.1 mm to approximately 5 mm. Furthermore, the annular flexible component may have a thickness of approximately 0.05 mm to approximately 0.75 mm. Moreover, the annular flexible component may be made of or may contain (but is not limited to) silicone, acrylics, poly(methyl methacrylate), hydrogels, or combinations thereof. Still further, in this embodiment, when installed inside the natural lens capsule, the annular rigid component and the annular flexible component form an angle of approximately 2 degrees to approximately 90 degrees.

[0048] In another embodiment of the invention, a device is provided for flexibly restoring tension to a natural lens capsule after cataract surgery, the device comprising: an annular rigid assembly including: a distal end positioned in a support relationship with the anterior surface of the capsule, and a proximal end positioned in a support relationship with the posterior surface of the capsule and adjacent to the Wiegand ligament of the eye, and a protrusion formed from the top of the distal end of the rigid assembly; an annular flexible assembly substantially concentric with the rigid assembly and flexibly mounted adjacent to the inner surface of the capsule, the annular flexible assembly being configured to bend away from the rigid assembly when the ciliary muscle relaxes and the fasciculus lesser is tensioned, and to bend toward the rigid assembly when the ciliary muscle contracts and the fasciculus lesser is relaxed, the flexible assembly including: a proximal end formed on the outer surface of the proximal end of the rigid assembly, and a distal end extending away from the rigid assembly; and a groove provided on the inner surface of the rigid assembly, the groove being configured to receive a tactile element on an intraocular lens.

[0049] Furthermore, in this embodiment, the device may include a plurality of markers disposed on the top surface of the protrusion, configured to guide the alignment of the toric lens. In another further embodiment, the device may include a plurality of gaps disposed around the circumference of the annular flexible assembly, configured to enhance the flexibility of the annular flexible assembly. In this further embodiment, each gap may have a width of approximately 0.1 mm to approximately 5 mm.

[0050] In all embodiments, the protrusion may have a width of about 0.1 to about 1 mm. Furthermore, the proximal end of the rigid component may have a thickness of about 0.2 mm to about 1 mm, and the distal end of the rigid component may have a thickness of about 0.1 mm to about 0.5 mm. Additionally, the annular rigid component may be made of or may contain (but is not limited to) silicone, acrylics, poly(methyl methacrylate), hydrogels, or combinations thereof. Furthermore, the annular rigid component may be substantially perpendicular to the anterior surface of the natural lens capsule. Still further, when disposed within the natural lens capsule, the annular rigid component and the annular flexible component form an angle of about 2 degrees to about 90 degrees.

[0051] In another embodiment of the invention, a system is provided for flexibly restoring tension to the natural lens capsule after cataract surgery, the system comprising: the device for restoring tension described above; and an elastic annular body having an opening formed therein around the inner circumference of the annular body in a clamping configuration.

[0052] In this embodiment, the resilient annular body may include an upper portion having a tongue hanging down from its lower surface and a lower portion having a groove disposed around its upper surface, the groove being configured to receive the tongue within the groove. Furthermore, in this embodiment, the resilient annular body may have an inner diameter of about 5 to 8 mm and an outer diameter of about 6 mm to about 10 mm. Additionally, the resilient annular body may comprise a material whose elastic properties are substantially similar to those of the anterior peripheral region of the sac in a young person's eye.

[0053] In another embodiment of the invention, a device for tightening the eye capsule after cataract surgery is provided, the device comprising an elastic annular body having an upper and lower portion of a clamping structure formed by openings into the annular body around its outer perimeter.

[0054] In this embodiment, the upper portion may include a tongue hanging down from its lower surface, and the lower portion has a groove disposed around its upper surface, the groove being configured to receive the tongue within the groove. Furthermore, in this embodiment, the resilient annular body may have an inner diameter of about 5 to 8 mm and an outer diameter of about 6 mm to about 10 mm. Additionally, the resilient annular body may comprise a material whose elastic properties are substantially similar to those of the anterior peripheral region of the sac in a young person's eye.

[0055] In another embodiment of the invention, a tensioning device for the natural capsule of the eye after cataract surgery is provided, the tensioning device comprising: an elastic annular body including an upper component and a lower component, the upper component having an upper body portion and a lower body portion separated in a clamp-like configuration by an opening formed therein around its inner circumference, the lower component being formed to hang down from the lower surface of the lower body portion at its upper end; and a flexible annular body substantially concentric with and extending outwardly from the lower end of the lower component. Further, in this embodiment, the lower component may include a groove disposed around its inner surface, the groove being configured to receive a tactile element on an intraocular lens.

[0056] In both embodiments, the upper body portion may include a tongue hanging down from its lower surface, and the lower portion has a groove disposed around its upper surface, the groove being configured to receive the tongue within the groove. Furthermore, in this embodiment, the resilient annular body may have an inner diameter of about 5 to 8 mm and an outer diameter of about 6 mm to about 10 mm. Additionally, the lower component of the resilient annular body may have a thickness of about 0.2 mm to about 1 mm at its proximal end and a thickness of about 0.1 mm to about 0.5 mm at its distal end. Furthermore, the flexible annular body may have a thickness of about 0.05 mm to about 0.75 mm.

[0057] In both embodiments, the elastic annular body may comprise a material whose elastic properties are substantially similar to those of the anterior peripheral region of the capsule in a young person's eye. Furthermore, the flexible annular body may comprise silicone, acrylics, hydrogels, or combinations thereof.

[0058] In one aspect of the two embodiments, the flexible annular body may include a continuous surface. In another aspect, the flexible annular body may include a plurality of gaps circumferentially disposed thereon. In this aspect, each of the plurality of gaps has a width of about 0.1 mm to about 5 mm.

[0059] This document provides a device for repairing capsule 1 after cataract surgery. It also provides a device for tightening the capsule after cataract surgery, which can be used alone or in conjunction with the capsule repair device. As described below, the invention offers numerous advantages and uses; however, such advantages and uses are not limited by this description. Embodiments of the invention are better illustrated with reference to one or more accompanying drawings; however, such reference is not intended to limit the invention in any way. The embodiments and variations described in detail herein are interpreted by the appended claims and their equivalents.

[0060] As in Figure 1As shown, the eye's lens switches between a flat shape 2a and a convex shape 2b when the ciliary muscle relaxes or contracts to adjust the visual focus. More specifically, when the eye observes a distant target, the ciliary muscle relaxes 3a and the fasciculus lesser 4a tightens, resulting in a flat lens. When the ciliary muscle contracts 3b and the fasciculus lesser relaxes 4b, the eye's lens is in a convex shape 2b, providing greater refractive power. Therefore, a concentric ring device 5 is used to adjust the flexibility of the eye's dynamic structure.

[0061] like Figure 2 As shown, the device has a V-shaped cross-sectional surface. The device includes a rigid component 9 and a flexible or deformable component 7 (in the unstressed state) or 7' (in the stressed state) disposed outside or behind the rigid component. The proximal end of the flexible component is formed on the outer surface of the proximal end of the rigid component. When placed within the natural lens capsule, the rigid component 9 supports the lens capsule, while the flexible component 7' is mounted abutting and in contact with the side surface of the lens capsule, configured to contract or relax with the contraction or relaxation of the capsule. Typically, the rigid component may be perpendicular to the anterior surface of the lens capsule.

[0062] Figure 3 The diagram shows that when the device is placed in the natural lens capsule, the proximal end of the rigid component is positioned close to the Wigger ligament 8. The outer surface of the flexible component is in direct contact with the inner surface of the capsule. The flexible component is under constant pressure from the capsule. This prevents any fibroblasts and lens epithelial cells from migrating into the posterior capsule. Preferably, the angle between the rigid and flexible components is from about 0 degrees to about 90 degrees when the capsule contracts and relaxes. The rigid and flexible components can be made individually of biocompatible materials, such as, but not limited to, silicone, acrylics such as poly(methyl methacrylate), hydrogels, or combinations thereof. The thickness of the rigid and flexible components defines the parameters of flexibility and rigidity.

[0063] As in Figure 4 As shown, the top 10 of the rigid component, which contacts the anterior part of the capsule, is thinner than its bottom 6, which contacts the posterior part of the capsule. A protrusion 18 is formed at the distal end of the top of the rigid component. The diameter of the top 10 of the rigid component can be greater than or substantially equal to the diameter of its bottom 6. This conical shape of the rigid component creates a better field of vision for the surgeon and allows them to see the groove 11 during eye surgery, providing a convenient route for placing and aligning the lens 13. Preferably, the thickness of the rigid component can be from 0.1 mm to 1 mm. The thickness of the flexible component can be from 0.05 mm to 0.75 mm.

[0064] Figure 5An annular groove 11 is shown disposed on the inner surface of a rigid component and configured to mate with or receive and secure a tactile element 12 to an artificial lens. The groove 11 keeps the lens well aligned and centered in the capsule. Once the tactile element 12 is placed in the groove 11 on the lens 13, the groove 11 removably secures the tactile element 12 and prevents the lens 13 from tilting or twisting.

[0065] Figure 6 The illustration shows an intraocular lens with an asymmetric tactile element 14 being placed in an annular groove 11. This is used for mounting high-end intraocular lenses in the eyes of patients with a high κ angle in cases of pupillary deflection with respect to the optical axis (where the deflection is greater than 0.2 mm).

[0066] Figure 7 and Figure 8 The corresponding parts of the device are shown in the side view and top view, respectively. Specifically, Figure 8 A plurality of markers 16 are shown on the top surface of a protrusion formed on a rigid component.

[0067] exist Figure 9 In this design, multiple gaps, as indicated by 17a and 17b, are arranged along the circumference of the flexible component to enhance its flexibility. These gaps divide the flexible component into multiple discontinuous segments, as indicated by 7a and 7b.

[0068] Figure 10 The elastic annular body of the tensioning device 20 is depicted. The device is an elastic, substantially annular or ring-shaped body with a clamping structure. The annular body has an upper portion 22 or upper body portion and a lower portion 24 or lower body portion. An opening 26 around the outer circumference into the annular body enables the clamping action of the device. The upper portion includes a tongue 22a hanging downwards from its inner surface. The lower portion includes a groove 24a disposed around its inner surface, which is positioned therein to receive the tongue.

[0069] The flexible annular device is placed around the outer periphery of the rupture capsule, thereby securing the edge between the tongue and the groove, and also securing the device adjacent to the outer periphery of the rupture capsule. A clamp or clip-like structure (see...) Figure 12 The resilient ring device is secured to the sac using a bioadhesive or other fixation tool to ensure it is firmly attached to or within the sac. When secured to the peripheral tear edge of the sac, the resilient ring causes the sac to pull the outer resilient portion of the peripheral tear edge toward the center.

[0070] The elastic annular body is made of one or more materials whose elastic properties are similar to or the same as those of a natural sac (particularly in a given anterior peripheral region of the sac in the eyes of young people). The elastic annular body has an inner diameter of about 5 to 8 mm and an outer diameter of about 6 to 10 mm.

[0071] Continue to refer to Figure 2 , Figure 11 A cross-section is shown of the resilient annular device 20 used in conjunction with the lens capsule repair device 1. The resilient annular device remains fixed to the peripheral capsule tear edge regardless of whether the flexible components of the lens capsule repair device are in the untensioned state 7 or the tensioned state 7'.

[0072] Figure 12 A tensioning device 30 is described, comprising a clip-like structure to secure the device within the capsular bag after cataract surgery. The tensioning device includes an elastic annular body 20 as an upper component, a lower component 32, and a flexible annular body 36.

[0073] The lower component extends from the lower surface of the lower body portion 24 at its upper end 32a, such that when the peripheral capsular edge is secured by the resilient annular body, the lower end 32b of the lower component is positioned abutting the anterior surface of the capsular. The lower component of the device includes a groove 34 circumferentially disposed around its inner surface and configured to receive a tactile element on the intraocular lens. The lower component of the resilient annular body has a thickness of about 0.2 mm to about 1 mm at its upper end and a thickness of about 0.1 mm to about 0.5 mm at its lower end. The lower component may be made of one or more elastic materials similar to the resilient annular body 20.

[0074] The flexible annular body 36 is substantially concentric with the upper component 20 and lower component 32 of the tensioning device and extends flexibly upward from the lower end 32b of the lower component. When the tensioning device is placed within the capsule, the outer surface 36a of the flexible annular body is in direct contact with the inner surface of the capsule. The flexible annular body is under constant pressure from the capsule. The angle between the lower component and the flexible annular body can vary between 0 degrees and approximately 90 degrees as the capsule contracts and relaxes. The flexible annular body may have a thickness of approximately 0.05 mm to approximately 0.75 mm and contains a biocompatible material, such as, but not limited to, silicone, acrylics, hydrogels, or combinations thereof. The surface of the flexible annular body may be continuous or may include a plurality of circumferentially arranged gaps similar to the gaps 17a, b on the flexible component 7 of the lens restoration device 1. Each of the plurality of gaps may have a width of approximately 0.1 mm to approximately 5 mm.

[0075] This invention is well-suited to achieving the aforementioned results and advantages, as well as those inherent therein. The specific embodiments disclosed above are merely illustrative, as the invention can be modified and practiced in different but equivalent ways that will be apparent to those skilled in the art who have benefited from the teachings herein. Furthermore, it is not intended to limit the details of the structures or designs shown herein, except as described in the following claims. Therefore, it will be apparent that the specific illustrative embodiments disclosed above can be changed or modified, and all such changes are considered to be within the scope and spirit of the invention. Moreover, unless expressly and clearly defined otherwise by the patentee, the terms in the claims have their ordinary, conventional meaning.

Claims

1. A system for flexibly restoring tension to the natural lens capsule after cataract surgery, the system comprising: A prosthetic capsule device for repairing the natural lens capsule of the eye after cataract surgery, the device comprising a housing configured to receive an artificial lens (IOL), the housing comprising: Annular rigid assembly, the annular rigid assembly comprising: A distal end having a thickness of 0.1 mm to 0.5 mm, the distal end being configured in a support relationship with the anterior surface of the natural lens capsule; A proximal end having a thickness of 0.2 mm to 1 mm, the proximal end including a capsular engagement surface configured to provide support to the posterior surface of the natural lens capsule and configured to be located close to the Wiegand ligament of the eye; and A protrusion formed from the top of the distal end of the rigid component, the protrusion including a bladder-engaging top surface and a plurality of markers disposed on the top surface; and A circumferential wall extending from the proximal end to the distal end; A concentric annular flexible component, having a thickness of 0.05 mm to 0.75 mm, defining a circumferential wall for capsule engagement, the annular flexible component being configured to flexibly mount close to the inner surface of the natural lens capsule, the flexible component comprising: The proximal end is formed on the outer surface of the proximal end of the rigid component; Extending forward and away from the distal end of the rigid component, the distal end being a free end; and A plurality of gaps are arranged around the circumference of the annular flexible component, the plurality of gaps being configured to improve flexibility; and A groove is provided on the inner surface of the rigid component, the groove being configured to receive the tactile element of the artificial lens. The annular flexible component is disposed around the outer periphery of the circumferential wall of the annular rigid component. The annular flexible component is configured to bend away from the annular rigid component when the ciliary muscle relaxes and the fasciculus minor is tensioned, and is configured to bend towards the annular rigid component when the ciliary muscle contracts and the fasciculus minor relaxes. The maximum thickness of the distal end of the annular rigid component is less than the maximum thickness of the proximal end of the annular rigid component; and A flexible annular body having an opening formed therein around the outer circumference of the annular body in a clamping configuration, the flexible annular body having an inner diameter of 5 to 8 mm and an outer diameter of 6 mm to 10 mm, the flexible annular body including an upper part and a lower part, the upper part having a tongue hanging down from the lower surface of the upper part, and the lower part having a groove disposed around the upper surface of the lower part, the groove being configured to receive the tongue within the groove.

2. The system of claim 1, wherein the plurality of markers are guides for toric lens alignment.

3. The system of claim 1, wherein each of the gaps has a width of 0.1 mm to 5 mm.

4. The system of claim 1, wherein the protrusion has a width of 0.1 mm to 1 mm.

5. The system of claim 1, wherein the annular rigid component is perpendicular to the anterior surface of the natural lens capsule.

6. The system of claim 1, wherein the annular rigid component and the annular flexible component form an angle of 0 to 90 degrees when disposed inside the natural lens capsule.

7. The system of claim 1, wherein the elastic annular body comprises a material having elastic properties similar to those of the anterior peripheral region of the sac in a young person's eye.

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