Capsular bag reconstruction method and tensioning device

Abstract

To provide devices used to reconstruct a natural lens capsule after a cataract surgery.SOLUTION: Devices utilize substantially ring-shaped rigid and flexible components to contact the posterior and anterior surfaces of a lens capsule after a cataract surgery to reconstruct the capsular shape. Also provided are devices for tensioning a lens capsule after a cataract surgery. An elastic ring-like body is shaped to secure the rim of a capsulorhexis in a clip-like configuration. Alternatively, the elastic ring-like body is formed with a lower component that depends upon the body and a flexible ring-shaped body extending from the lower component similarly to the rigid and flexible components of the capsule reconstructing device.SELECTED DRAWING: Figure 1

Description

[Background technology]

[0001] <CROSS REFERENCE TO RELATED APPLICATIONS> This international application claims the benefit of priority under 35 U.S.C. §120 from pending U.S. nonprovisional patent application Ser. No. 15 / 446,121, filed Mar. 1, 2017, the entirety of which is incorporated herein by reference. [Technical field]

[0002] The present invention relates to the field of ophthalmic and surgical devices for operations on the eye. More specifically, the present invention relates to instruments for the functional and anatomical reconstruction of the human lens capsule and for the precise positioning of an intraocular lens for any surgery requiring the replacement and positioning of a lens.

[0003] <Details of related technology> An intraocular lens is a plastic lens that has substantially the same visual capabilities as the natural crystalline lens that it is intended to replace. Typically, during cataract surgery, an ophthalmologist removes the natural crystalline lens that has been damaged by cataract and replaces it with an artificial intraocular lens. There are three types of intraocular lenses, including refractive lenses, diffractive lenses, and refractive diffractive lenses. Refractive lenses focus light toward a focal point on the optical axis by refraction, while diffractive lenses generate a diffraction pattern that forms one focal point on the optical axis for each diffraction order. Refractive diffractive lenses combine the features of both types. However, these purely refractive bifocal or multifocal lenses have some significant drawbacks. First, their effectiveness is highly dependent on the size and centering of the pupil. Second, because they have several foci, the resulting differentiation is reduced. This, together with the reduced luminosity, may induce the formation of halos, especially in distance vision (see, for example, U.S. Pat. No. 5,399,333).

[0004] Additionally, posterior capsule opacification (PCO, or post-cataract) remains a common problem after cataract surgery involving the implantation of an intraocular lens. Posterior capsule opacification typically results from the transition from intracapsular cataract extraction (ICCE) to extracapsular cataract extraction (ECCE) when the posterior lens capsule is left intact during surgery. Patients with posterior capsule opacification suffer from reduced vision, impaired contrast sensitivity, and glare insensitivity. Clinically, the components of posterior capsule opacification are identified as the regenerative component and the fibrous component, with the regenerative posterior capsule opacification component being much more common than the fibrous component.

[0005] Regenerative posterior capsule opacification is caused by residual lens epithelial cells (LECs) from the equatorial region of the lens, so-called e-cells, which migrate into the space between the posterior capsule and the intraocular lens and proliferate to form the lens material and the layer of the Elschnig pearl. In contrast, fibrous posterior capsule opacification is caused by LECs from the anterior capsule that transform into myofibroblasts and approach the posterior capsule, causing the capsule to bleach and wrinkle. This can result in dispersion of the intraocular lens and impede visualization of the peripheral retina. (Non-Patent Document 1) discloses that both components of posterior capsule opacification result in reduced visual function when they affect the central area around the visual axis. YAG or Nd lasers utilized in YAG laser capsulorhexis are most commonly used to treat posterior capsule opacification. However, as disclosed in (Non-Patent Document 2), laser capsulorhexis can result in other complications such as retinal detachment or elevated intraocular pressure.

[0006] (US Pat. No. 5,399,433) describes the need for a "disrupting device" to maintain a substantially circular capsule shape after lens extraction, and to address disruption problems such as the ingress of deformed epithelial cells into the posterior capsule, as well as the need for a disrupting device that will hold the intraocular lens in a favorable position by the formation of a groove in its inner circumference. He describes the stable circular shape of the device as effective in disrupting capsule shrinkage, without reference to the actual diameter of the outer portion of the annulus.

[0007] (Patent Document 3) describes a device attached to the natural capsular bag so that the capsule may be held in a certain configuration to avoid post-operative changes detrimental to vision. Single or dual optic systems are provided, which may be accommodated. The role of "post-operative shortening" of the empty capsule in lens replacement, resulting in changes in vision and induction of astigmatism, is emphasized. Thus, there is a need to provide a device or instrument and procedure that maintains the shape of the capsule as well as the diameter of the capsular incision opening for the device.

[0008] (Patent Document 4) describes that "spatial relationships of structures such as the distance from the surface of the cornea to the posterior surface of the lens capsule, and the distance from the cornea or the posterior surface of the lens capsule to the retina" are measured preoperatively, for example by using ultrasound, partial coherence interferometry, optical coherence tomography or laser measurement techniques, or by any other means known in the art, thus establishing preoperative anatomical relationships. A surgical procedure, such as intraocular lens implantation, is performed, and spacing means are provided to restore those premeasured spatial relationships or predetermined new spacing. Spacing means may include, for example, spacers, rings, expandable structures, thick or multiple lenses. These means help maintain the normal depth of the patient's anterior and posterior capsules and prevent progression of vitreous and retinal detachment that may result from such movements.

[0009] (Non-Patent Document 3) describes "the crossing zonules cradle, a shape that stabilizes the posterior lens. In the model, the anterior vitreous zonules insert into Weiger's ligament, and the PIZ-LE zonules anchor the lens equator to the posterior insertion zone. The crossing zonules and Weiger's ligament maintain the alignment of the lens, while the anterior and posterior zonules provide reciprocal accommodation and maladaptation. The Weiger's ligament, which represents the central peripheral zone of the posterior capsule, is the most important area for stabilizing the position of the lens during accommodation.

[0010] (Patent Document 5) describes an intraocular lens device having a ring-shaped fixation platform that can create a "structure" to which the intraocular lens of the present invention can be attached, and concludes that the findings of the present invention enable a surgical method for the insertion, subsequent removal, and exchange of intraocular lenses with reduced risk of trauma to the eye or loss of vision.

[0011] Based on (Non-Patent Document 4), the market for expensive intraocular lenses will reach 9.3% worldwide and 34% of the total revenue of the global intraocular lens market. Multifocal and toric IOLs will occupy the market for expensive intraocular lenses with a market share of about 90%. Toric and multifocal are very sensitive to accurate centration and positioning inside the capsular bag.

[0012] Several patents and publications, including U.S. Pat. No. 6,299,433; U.S. Pat. No. 6,343,666; U.S. Pat. No. 6,493,369; U.S. Pat. No. 6,511,136; U.S. Pat. No. 6,511,136; and U.S. Pat. No. 6,511,136, disclose various intracapsular rings for different purposes. However, these studies describe rings with either one standard size or various sizes without adjustability for accommodation. These devices generally include a ring and ocular tissue suitable for the ring. Some of the devices include a deformable ring that changes the shape of the central visual portion under the pressure of the ciliary body, mimicking an accommodation mechanism.

[0013] Due to the complexities of zonular traction for multifocal and toric intraocular lenses already on the market and expected to rapidly improve in the near future, none of the previous work in this field considers the modern theory of accommodation and maintenance of continuous changes in the shape of the capsular bag. Thus, there is a recognized need in the art for devices and methods for reconstructing the capsular bag. In particular, the prior art is deficient in devices that allow for precise placement and alignment of an intraocular lens post-operatively. The present invention fulfills this long-standing need and desire in the prior art. [Prior art documents] [Patent documents]

[0014]

Patent Document 1

Patent document 2

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Patent document 4

Patent document 5

Patent document 6

Patent document 7

Patent document 8

Patent document 9

Patent document 10

Patent document 11

Patent document 12

Patent document 13

Non-licensed literature

[0015]

Non-licensed literature 1

Non-licensed Document 2

[0016] The present invention is directed to a device for reconstructing the natural lens capsule of an eye after cataract surgery. The device includes a ring-shaped rigid component. The rigid component includes a distal end that abuts the anterior surface of the lens capsule and a proximal end that is disposed on the posterior surface of the lens capsule and against the Wiegers ligament in the eye. A ring-shaped flexible component that is substantially concentric with the rigid component is flexibly fitted against an inner surface of the lens capsule. The ring-shaped flexible component includes a proximal end formed on an outer surface of the proximal end of the rigid component and a distal end that extends away from the rigid component. A groove is disposed on the inner surface of the rigid component that is configured to receive the haptics of an intraocular lens. The present invention is directed to a related device further including a ledge formed from an apex of the distal end of the rigid component.

[0017] The present invention is also directed to a device for flexibly restoring tension in the natural lens capsule after cataract surgery. The device includes a ring-shaped rigid component with a distal end disposed in supporting relationship with the anterior surface of the lens capsule, a proximal end disposed in supporting relationship with the posterior surface of the lens capsule and against the eye at the Weiger's ligament, and a ledge formed from the apex of the distal end of the rigid component. The ring-shaped flexible component, substantially concentric with the rigid component, is flexibly fitted against the inner surface of the lens capsule. The flexible component is configured to bend away from the rigid component when the ciliary muscle is relaxed and the zonules are taut, and to bend towards the rigid component when the ciliary muscle is contracted and the zonules are relaxed. The ring-shaped flexible component includes a proximal end formed on an outer surface of the proximal end of the rigid component and a distal end extending away from the rigid component. A groove is disposed on the inner surface of the rigid component configured to receive the haptics of an intraocular lens. The present invention is directed to a related device further including a number of markers disposed on the upper surface of the ledge configured to guide toric lens alignment.The present invention is directed to other related devices further including a number of gaps disposed around the circumference of said ring-shaped flexible component configured to improve its flexibility.

[0018] The present invention is also directed to a system for flexibly restoring tension in the natural lens capsule following cataract surgery, the system including an apparatus for flexibly restoring tension in the natural lens capsule as described herein, and an elastic, toroid-shaped body having an opening therein formed with a clip-like structure around an inner circumference of the toroid-shaped body.

[0019] The present invention is still further directed to a device for tensioning the eye's natural lens capsule after cataract surgery, the device including an elastic ring-like body having upper and lower portions with a clip-like structure formed with an opening around the circumference of the ring-shaped body.

[0020] The present invention is also directed to a device for tensioning the natural lens capsule of the eye after cataract surgery. The tensioning device includes a resilient ring-shaped body and a flexible ring-shaped body that is substantially concentric and extends outwardly from a lower end of a lower component. The resilient ring-shaped body includes an upper component with upper and lower body portions separated by a clip-like structure by an opening formed therein around an inner circumference, and a lower component formed to depend at an upper end from a lower surface of the lower body portion. The present invention is directed to a related tensioning device in which the lower component of the resilient ring-shaped body configured to receive the haptics of an intraocular lens includes grooves disposed around an inner surface.

[0021] Other and further aspects, features, and advantages of the present invention will become apparent from the following description of the presently preferred embodiments of the invention, which are given for the purpose of disclosure. [Brief description of the drawings]

[0022] In addition to the above detailed features, advantages and objects of the present invention, others which will become more apparent, are achieved and can be understood in detail in a more particular description, and certain embodiments of the invention briefly summarized above are illustrated in the accompanying drawings, which form a part of the specification. It is noted, however, that the accompanying drawings illustrate preferred embodiments of the invention and are therefore not to be considered as limiting its scope. [Figure 1] Depicts the anatomy of the lens capsule and the ligament of Weiger with (left) and without (right) contraction of the ciliary body. [Diagram 2] A cross-sectional view of the device showing the free form (right side) as well as the flexible components of the device fitted against the sides of the eye's capsular bag. [Diagram 3] 1 is a cross-sectional view of the device showing the proximal end of the device being positioned within the capsular bag and against Weiger's ligament. [Figure 4]FIG. 2 is a cross-sectional view of the device showing that the diameter of the anterior surface of the capsular bag is larger than that of its posterior surface. [Diagram 5] FIG. 13 is a cross-sectional view of the device showing an intraocular lens being placed in the device by inserting its haptics into grooves located on the interior surface of the rigid component. [Figure 6] 1 is a cross-sectional view of the device showing an asymmetric intraocular lens being placed in the device. [Figure 7] FIG. 2 is a cross-sectional view from the device side showing the rigid and flexible components. [Figure 8] FIG. 13 is a plan view of the device showing multiple markers positioned on the top surface of the rigid component to provide guidance for toric intraocular lens alignment. [Figure 9] FIG. 1 is a plan view of the device showing a number of gaps located along the periphery of the flexible component to improve its flexibility. [Figure 10] FIG. 13 is a cross-sectional view of one embodiment of a tensioning device such as an elastic ring. [Figure 11] 3 is a cross-sectional view of FIG. 2 further illustrating in cross section the positioning of a tensioning device, such as an elastic ring, in securing the edges of the capsulotomy. [Figure 12] 11A-11C are cross-sectional views of another embodiment of a tensioning device illustrating the placement of an elastic ring-shaped body and a flexible ring-shaped body relative to the edges of the capsulotomy and the capsule. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0023] As used herein, the following terms and phrases shall have the meanings indicated below: Unless otherwise defined, all technical and scientific terms have the same meaning as commonly understood by one of ordinary skill in the art.

[0024] As used herein, the terms "a" and "or one" may mean one or more. As used herein, in a claim, when used in conjunction with the word "comprising," the word "a" or "an" may mean one or more. As used herein, "another" or "other" may mean at least a second or more of the same or different claim elements or components thereof. The terms "comprise" and "comprising" are used in an inclusive and open sense, meaning that additional elements may be included.

[0025] As used herein, although the disclosure establishes a definition that refers only to alternatives and "and / or," the term "or" in the claims refers to "and / or" unless expressly stated to refer only to alternatives or to alternatives that are mutually exclusive.

[0026] As used herein, the term "about" refers to numerical values, including, for example, all numbers, fractions, and percentages, whether or not expressly stated. The term "about" generally refers to a range of numbers (e.g., + / - 5 to 10% of the recited value) that one of ordinary skill in the art would consider equivalent to the recited value (e.g., having the same function or result). In some instances, the term "about" may include numerical values ​​that are rounded to the nearest significant figure.

[0027] As used herein, the term "distal end" refers to the end that is away from the posterior surface of the capsular bag, and the term "proximal end" refers to the end that is toward the posterior surface of the capsular bag.

[0028] As used herein, the terms "substantially ring-like," "ring-like," and "toroid-shaped" are used interchangeably and refer to a three-dimensional shape of the devices described herein that resembles or resembles a donut, for example.

[0029] In one embodiment of the invention, a device is provided for reconstructing an eye's natural lens capsule after cataract surgery, the device comprising: a ring-shaped rigid component having: a distal end abutting an anterior surface of the lens capsule; and a proximal end positioned against the Weeger's ligament in the eye; a ring-shaped flexible component substantially concentric with the rigid component and flexibly fitted against an inner surface of the lens capsule, the ring-shaped flexible component having: a proximal end formed on an outer surface of the proximal end of the rigid component; and a distal end extending away from the rigid component; and a groove disposed on an inner surface of the rigid component configured to receive a haptic on an intraocular lens.

[0030] In addition to this embodiment, the device may further include a ledge formed from a top of the distal end of the rigid component. In this further embodiment, the ledge may include a plurality of markers disposed on an upper surface thereof and configured to guide alignment of the toric lens. Also in this further embodiment, the ledge may have a width of about 0.1 mm to about 1 mm.

[0031] In both embodiments, the proximal end of the rigid component may have a thickness of about 0.2 mm to about 1 mm. Additionally, 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 include, but is not limited to, silicone, acrylic, poly(methyl methacrylate), hydrogel, or combinations thereof.

[0032] Also, in both embodiments, the ring-shaped rigid component may be substantially perpendicular to the anterior surface of the natural lens capsule, and in both embodiments, the ring-shaped flexible component may be configured to bend away from the rigid component when the ciliary muscle is relaxed and the zonules are taut and bend towards the rigid component when the ciliary muscle is contracted and the zonules are relaxed.

[0033] In addition to both embodiments, the ring-shaped flexible component may include a plurality of gaps disposed around its circumference. Further, each of the gaps may have a width of about 0.1 mm to about 5 mm. Further, the ring-shaped flexible component may have a thickness of about 0.05 mm to about 0.75 mm. Still further, the ring-shaped component may be made of or include, but is not limited to, silicone, acrylic, poly(methyl methacrylate), hydrogel, or combinations thereof. Still further, in this embodiment, the ring-shaped rigid component and the ring-shaped flexible component form an angle of about 2 degrees to about 90 degrees when seated within the natural lens capsule.

[0034] In one other embodiment of the present invention, there is provided an apparatus for flexibly restoring tension to a natural lens capsule after cataract surgery, the apparatus comprising: a ring-shaped rigid component having: a distal end disposed in supporting relationship with an anterior surface of the lens capsule; and a proximal end disposed in supporting relationship with a posterior surface of the lens capsule and disposed against the Weeger's ligament of the eye; and a ledge formed from an apex of the distal end of the rigid component; and a ring-shaped flexible component substantially concentric with the rigid component and flexibly fitted against an inner surface of the lens capsule. a flexible component configured to bend toward the rigid component when the ciliary muscle is relaxed and the zonules are taut, and configured to bend away from the rigid component when the ciliary muscle is contracted and the zonules are relaxed, the flexible component including: a ring-shaped flexible component including a proximal end formed on an outer surface of the proximal end of the rigid component; and a distal end extending away from the rigid component; and a groove disposed on an inner surface of the rigid component configured to receive a haptic on the intraocular lens.

[0035] In addition to this embodiment, the device may include a plurality of markers disposed on an upper surface of the ledge configured to guide alignment of the toric lens. In another further embodiment, the device may include a plurality of gaps disposed around a circumference of the ring-shaped flexible component configured to improve its flexibility. In this further embodiment, each of the gaps may have a width of about 0.1 mm to about 5 mm.

[0036] In all embodiments, the ledge may have a width of about 0.1 mm 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. Furthermore, the ring-shaped rigid component may be made of or include, but is not limited to, silicone, acrylic, poly(methyl methacrylate), hydrogel, or combinations thereof. Furthermore, the ring-shaped rigid component may be substantially perpendicular to the anterior surface of the natural lens capsule. Furthermore, the ring-shaped rigid component and the ring-shaped flexible component form an angle of about 2 degrees to about 90 degrees when placed within the natural lens capsule.

[0037] In yet another embodiment of the present invention, a system for flexibly restoring tension to a natural lens capsule after cataract surgery is provided, the system including: an apparatus for restoring tension as described above; and an elastic, toroid-shaped body having an opening therein with a clip-like structure formed around an inner circumference of the toroid-shaped body.

[0038] In this embodiment, the elastic toroid-shaped body may include an upper portion with a tongue depending from its lower surface, and a lower portion with a groove disposed about its upper surface configured to receive the tongue within the groove. Further, in this embodiment, the elastic toroid-shaped body may have an inner diameter of about 5 to 8 mm, and an outer diameter of about 6 to 10 mm. Further, the elastic ring-like body may comprise a material having elastic properties substantially similar to the elastic properties of the anterior edge of the lens capsule in a young human eye.

[0039] In yet another embodiment of the present invention, a device for tensioning the lens capsule of an eye after cataract surgery is provided, the device including an elastic ring-shaped body having an upper and lower portion with a clip-like structure formed with an opening around the circumference of the ring-shaped body.

[0040] In this embodiment, the upper portion may include an upper portion with a tongue depending from its lower surface, and a lower portion with a groove disposed about the upper surface configured to receive the tongue within the groove. Also, in this further embodiment, the elastic ring-like body may have an inner diameter of about 5 to 8 mm, and an outer diameter of about 6 to 10 mm. Furthermore, the elastic ring-like body may comprise a material having elastic properties substantially similar to the elastic properties of the anterior edge of the lens capsule in a young human eye.

[0041] In yet another embodiment of the present invention, a tensioning device for the natural lens capsule of an eye following cataract surgery is provided, the device comprising an elastic ring-shaped body including an upper component with upper and lower body portions separated by a clip-like structure with an opening formed therein around an inner periphery, and a lower component formed to depend at an upper end from a lower surface of the lower body portion; and a flexible ring-shaped body substantially concentric with and extending outwardly from the lower end of the lower component. In addition to this embodiment, the lower component may include grooves disposed about an inner surface thereof configured to receive haptics on the intraocular lens.

[0042] In both embodiments, the upper body may include an upper portion with a tongue depending from its lower surface, and a lower portion with a groove disposed around the upper surface configured to receive the tongue within the groove. Also, in this further embodiment, the elastic ring-shaped body may have an inner diameter of about 5 to 8 mm, and an outer diameter of about 6 to 10 mm. Furthermore, the elastic ring-shaped lower component may have a thickness of about 0.2 mm to about 1 mm at the proximal end and a thickness of about 0.1 mm to about 0.5 mm at the distal end. Furthermore, the flexible ring-shaped body may have a thickness of about 0.05 mm to about 0.75 mm.

[0043] In both embodiments, the elastic ring-shaped body may comprise a material having elastic properties substantially similar to the elastic properties of the anterior edge of the lens capsule in a young human eye, and further, the flexible ring-shaped body may comprise silicone, acrylic, hydrogel, or combinations thereof.

[0044] In one aspect of both embodiments, the flexible ring-shaped body may include a continuous surface. In another aspect, the flexible ring-shaped body may include a plurality of circumferentially disposed gaps. In this aspect, each of the plurality of gaps has a width of about 0.1 mm to about 5 mm.

[0045] Provided herein is an apparatus for the reconstruction of the capsular bag (1) after cataract surgery. Also provided is an apparatus for tensioning the capsular bag after cataract surgery, which may be used alone or in conjunction with the capsular bag reconstruction apparatus. The invention has many advantages and uses, as described below. However, such advantages and uses are not limited by such description. An embodiment of the invention is better illustrated with reference to the figures. However, such references are not intended to limit the invention in any manner. The embodiments and variations described in detail herein are to be construed in accordance with the appended claims and equivalents thereto.

[0046] As shown in Figure 1, when the ciliary muscle relaxes or contracts to adjust the visual focus, the eye's lens switches between flattened (2a) or convex (2b). More specifically, when the eye is looking at a distant object, the ciliary muscle is relaxed (3a) and the zonules (4a) are tensed, resulting in a flattened lens. When the ciliary muscle is shortened (3b) and the zonules are relaxed (4b), the eye's lens is in a convex shape (2b), providing additional refractive power. Therefore, a concentric ring-shaped device (5) is used to accommodate the flexibility of the eye's soft structures.

[0047] As shown in FIG. 2, the device has a V-shaped cross section. The device includes a rigid component (9) and a flexible or deformable component (7) (without tension) or (7') (with tension) disposed on the outer or posterior side of the 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 capsular bag, the rigid component (9) supports the capsule, while the flexible component (7') is configured to fit against and contact the sides of the capsule and contract or relax with contraction or relaxation of the capsule. In general, the ring-shaped rigid component may be substantially perpendicular to the anterior surface of the natural capsule.

[0048] FIG. 3 illustrates that when the device is placed in the natural capsular bag, the proximal end of the rigid component is placed against the Weiger's ligament (8). The outer surface of the flexible component is in direct contact with the inner surface of the capsular bag. The flexible component is under constant pressure from the capsular bag. It blocks any fibroblasts and lens epithelial cells migrating into the posterior capsule. Preferably, when the capsular bag is contracted and relaxed, the angle between the rigid and flexible components is about 0 degrees to about 90 degrees. The rigid and flexible components may be made 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 flexibility and rigidity parameters.

[0049] As shown in FIG. 4, the top portion (10) of the rigid component, which abuts the anterior portion of the capsule, is thinner than its bottom portion (6), which abuts the posterior portion of the capsule. A ledge (18) is formed at the distal end of the top portion of the rigid component. The diameter of the top portion (10) of the rigid component may be larger than or substantially similar to that of its bottom portion (6). This cone-like shape of the rigid component creates a better field of view for the surgeon, allowing them to see the sulcus (11) during eye surgery. It provides an easy reach for them to place and align the lens (13). Preferably, the rigid component may have a thickness of 0.1 mm to 1 mm. The flexible component may have a thickness of 0.05 mm to 0.75 mm.

[0050] 5 illustrates that a ring-shaped groove (11) is disposed on the inner surface of the rigid component and is configured to fit or receive and secure the haptics (12) of an intraocular lens. The groove (11) keeps the lens properly aligned and centered in the lens capsule. Once the haptics (12) of the lens (13) are placed in the groove (11), the groove (11) movably secures the haptics (12) and prevents the lens (13) from tilting or twisting.

[0051] Figure 6 shows that an intraocular lens with asymmetric haptics (14) is placed in a ring-shaped groove (11), which is used to mount expensive intraocular lenses in the patient's eye with higher kappa angles when the pupil is decentered with respect to the visual axis and this decentering is 0.2 mm or more.

[0052] Figures 7 and 8 illustrate corresponding parts of the device in respective side and top views, In particular, Figure 8 shows a number of markers (16) disposed on the upper surface of a ledge formed on the rigid component.

[0053] In FIG. 9, a number of gaps are placed along the periphery of the flexible component to improve its flexibility, as represented by (17a) and (17b). These gaps divide the flexible component into many discontinuous segments, as represented by (7a) and (7b).

[0054] FIG. 10 illustrates a resilient ring-like body of a tensioning device (20). The device is a resilient substantially ring-like or toroid-shaped body with a clip-like structure. The ring-like body has an upper portion (22) or upper body portion, and a lower portion (24) or lower body portion. An opening (26) into the ring-like body around the periphery enables the clip-like action of the device. The upper portion includes a tongue (22a) depending downwardly from its inner surface. The lower portion includes a groove (24a) disposed around its inner surface that is positioned to receive the tongue.

[0055] The elastic ring-like device may be placed around the peripheral capsulotomy edge, whereby the edge is secured between the tongue and groove, and the device may be secured adjacent to the peripheral capsulotomy edge. The elastic ring-like device may be secured to the capsule with a clip or clip-like structure (see FIG. 12), or a bioadhesive material or other securing means, to ensure that the device fits securely on or is secured within the capsule. When secured to the peripheral capsulotomy edge, the elastic ring causes the capsule to pull the outer elastic portion of the peripheral capsulotomy edge toward the center.

[0056] The elastic ring-like body is made of one or more materials having elastic properties similar or equivalent to those of the natural lens capsule in a young human eye, particularly at a given anterior margin of the capsule. The elastic ring-like body has an inner diameter of about 5 to 8 mm and an outer diameter of about 6 to 10 mm.

[0057] With continued reference to Figure 2, Figure 11 illustrates in cross-section the use of an elastic ring-like device (20) with a capsular reconstructor (1). The elastic ring-like device remains secured to the peripheral capsular incision edge whether the flexible component of the capsular reconstructor is in tension (7) or not (7').

[0058] 12 illustrates a tensioning device (30) that includes a clip-like structure for securing the device in the capsular bag after cataract surgery. The tensioning device includes an elastic ring-shaped body (20) as an upper component, a lower component (32) and a flexible ring-shaped body (36).

[0059] The lower component extends at its upper end (32a) from the lower surface of the lower body portion (24) such that the lower end (32b) of the lower component rests against the anterior surface of the capsular bag when the peripheral capsular incision edge is secured by the elastic ring-shaped body. The lower component of the device includes grooves (34) disposed circumferentially about its inner surface and configured to receive the haptics of an intraocular lens. The elastic ring-shaped body lower component 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 the same elastic material or materials as the elastic ring-shaped body (20).

[0060] The flexible ring-shaped body (36) is substantially concentric with the upper (20) and lower (32) components of the tensioning device and flexibly extends upward from the lower end (32b) of the lower component. When the tensioning device is placed in the capsular bag, the outer surface (36a) of the flexible ring-shaped body directly contacts the inner surface of the capsular bag. The flexible component is under constant pressure from the capsular bag. The angle between the lower component and the flexible ring-shaped body may vary between 0 degrees and about 90 degrees as the capsular bag contracts and relaxes. The flexible ring-shaped body may have a thickness of about 0.05 mm to about 0.75 mm and may be made of biocompatible materials, including but not limited to, silicone, acrylic, hydrogel, or combinations thereof. Similar to the gaps (17a, b) on the flexible component (7) of the lens reconstruction device (1), the surface of the flexible ring-shaped body may be continuous or may include many gaps arranged circumferentially. Each of the plurality of gaps may have a width of about 0.1 mm to about 5 mm.

[0061] The present invention is well adapted to attain the objects and advantages mentioned, as well as those inherent therein. The specific embodiments disclosed above are merely illustrative, and the invention may be modified and practiced in different but equivalent manners apparent to those skilled in the art having the benefit of the teachings herein. Furthermore, no limitations to the details of construction or design shown herein are intended, other than as described in the following claims. It is therefore apparent that the specific exemplary embodiments disclosed above may be altered or modified, and all such variations are considered within the scope and spirit of the present invention. Moreover, the terms in the claims have their plain and ordinary meaning unless expressly indicated otherwise and unless expressly defined by the patentee.

Claims

1. 1. A system for flexibly restoring tension to a natural lens capsule after cataract surgery, the system comprising: A ring-shaped rigid component, a distal end having a thickness of 0.1 mm to 0.5 mm, the distal end being sized and positioned to be disposed in a supporting 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 capsule-engaging surface sized and configured to be disposed in a supporting relationship with a posterior surface of the natural capsule, the proximal end configured to be disposed against the Weeger's ligament of the eye; a ledge formed from an apex of a distal end of the ring-shaped rigid component, the ledge including a bag-engaging upper surface and a plurality of markers disposed on the bag-engaging upper surface; and a peripheral wall extending from said proximal end to said distal end a ring-shaped rigid component comprising: a ring-shaped flexible component defining a capsule-engaging peripheral wall substantially concentric with said ring-shaped rigid component, having a thickness of 0.05 mm to 0.75 mm less than a thickness of said distal end of said ring-shaped rigid component or a thickness of said proximal end of said ring-shaped rigid component, said ring-shaped flexible component being sized and configured to flexibly fit against an inner surface of said natural capsule, said ring-shaped flexible component comprising: a proximal end formed on an outer surface of the proximal end of the ring-shaped rigid component; a free distal end extending forward away from the ring-shaped rigid component; and a plurality of gaps disposed around a circumference of the ring-shaped flexible component configured to improve flexibility; A ring-shaped flexible component comprising: a groove formed on an inner surface of the ring-shaped rigid component configured to receive a haptic of an intraocular lens; and a resilient, toroid-shaped body having an exterior opening formed around an outer periphery of the toroid-shaped body with a clip-like structure; Including, wherein the ring-shaped flexible component is disposed around an outer periphery of a peripheral wall of the ring-shaped rigid component; the ring-shaped flexible component is configured to bend away from the ring-shaped rigid component when the ciliary muscle is relaxed and the zonules are taut, and to bend towards the ring-shaped rigid component when the ciliary muscle is contracted and the zonules are relaxed; a maximum thickness of the distal end of the ring-shaped rigid component is less than a maximum thickness of the proximal end of the ring-shaped rigid component; system.

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

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 ledge has a width of 0.1 mm to 1 mm.

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

6. The system of claim 1 , wherein the ring-shaped rigid component and the ring-shaped flexible component form an angle between 0 and 90 degrees when positioned within the natural lens capsule.

7. 2. The system of claim 1, wherein the resilient, toroid-shaped body includes an upper portion having a tongue depending from a lower surface thereof, and a lower portion having a groove disposed about the upper surface thereof, the lower portion configured to receive the tongue within the groove.

8. 10. The system of claim 1, wherein the resilient, toroid-shaped body has an inner diameter of about 5 to 8 mm and an outer diameter of about 6 to 10 mm.

9. 1. A tensioning device for the natural lens capsule of an eye following cataract surgery, said tensioning device comprising: A resilient ring-shaped body, an upper component having an upper body portion and a lower body portion separated by a clip-like structure with an opening formed in the periphery of a resilient ring-shaped body; and a resilient ring-shaped body including a lower component formed according to the shape of the lower surface of the lower body portion to the upper end of the lower body portion. a flexible ring-shaped body substantially concentric with the lower component and extending outwardly from a lower end of the lower component.

10. The tensioning device of claim 9 , wherein the bottom component further includes a groove disposed about an interior surface configured to receive a haptic on an intraocular lens.

11. 10. The device of claim 9, wherein the upper body portion includes a tongue depending from a lower surface thereof, and a lower portion including a groove disposed about an upper surface thereof and configured to receive the tongue within the groove.

12. The tensioning device of claim 9 , wherein the flexible ring-shaped body includes a continuous surface.

13. The tensioning device of claim 9 , wherein the flexible ring-shaped body includes a plurality of circumferentially disposed gaps.

14. The tensioning device of claim 13 , wherein each of the plurality of gaps has a width of about 0.1 mm to about 5 mm.

15. 10. The tensioning device of claim 9, wherein the resilient ring-shaped body has an inner diameter of about 5 to 8 mm and an outer diameter of about 6 to 10 mm.

16. 10. The tensioning device of claim 9, wherein the elastic ring-shaped body lower component has a thickness of about 0.2 mm to about 1 mm at the upper end and a thickness of about 0.1 mm to about 0.5 mm at the lower end.

17. 10. The tensioning device of claim 9, wherein the flexible ring-shaped body has a thickness of about 0.05 mm to about 0.75 mm.

18. The tensioning device of claim 9 , wherein the flexible ring-shaped body comprises silicone, acrylic, hydrogel, or a combination thereof.

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