Device and method for intraocular lens fixation

Abstract

Provided is a method of fixation of an intraocular lens (IOL) comprising: (a) inserting a fixation tool posterior to the iris; (b) grasping the IOL between two flat facing surfaces of a grasper of said fixation tool; and (c) anchoring a proximal end of said grasper to a sclera. Also provided is an intraocular lens (IOL) fixation tool, comprising: (a) an elongated body comprising a trans- scleral element; (b) a grasper at a distal end of said body comprising: (i) at least two axially extending arms which define flat facing grasping surfaces, (ii) means for approximating said arms towards each other so that they grasp.

Description

[0001] DEVICE AND METHOD FOR INTRAOCULAR LENS FIXATION

[0002] RELATED APPLICATION / S

[0003] This application claims the benefit of priority of Israel Patent Application No. 310169 filed on 15 January 2024, the contents of which are incorporated herein by reference in their entirety.

[0004] FIELD AND BACKGROUND OF THE INVENTION

[0005] The present invention, in some embodiments thereof, relates to methods of manipulating intraocular objects such as an intraocular lens (IOL) and, more particularly, but not exclusively, to an IOL fixation tool.

[0006] Cataract, opacification of the normally transparent crystalline lens that leads to blurred vision, is a very common condition in elderly people. The crystalline lens, which is composed of collagen and proteins, has no direct blood or nerve connections. 'The lens capsule is supported at its periphery by suspensor ligaments called zonules, which are continuous with the ciliary muscle.

[0007] Cataract surgery is the most common medical procedure worldwide with above 20 million surgeries completed annually. To restore the patient’s vision, the diseased lens (with the cataract) is surgically removed and replaced with an artificial lens, also known as an intraocular lens (IOL). An IOL is a disk-shaped transparent lens optic which is often attached to two smoothly curved attachment arms called “haptics”. A number of medically recognized techniques are known for removing a lens with cataract, including intracapsular extraction, extracapsular extraction and phacoemulsification (also called “Phaco”). In intracapsular extraction the zonules around the entire periphery of the lens capsule are severed and the entire lens structure, including the lens capsule, is removed. In extracapsular extraction and phacoemulsification, only the clouded material within the lens capsule is removed (e.g., using phacoemulsification with a small ultrasonic probe), while the transparent posterior lens capsule wall within its peripheral portion, as well as the zonules, are left in place in the eye.

[0008] Usually, implantation of the IOL is performed through an incision made near the periphery of the cornea, in either an anterior chamber of the anterior cavity (in front of the iris) or in the posterior chamber of the anterior cavity (posterior to the iris).

[0009] Fixation of the IOL in the posterior chamber can be also done by placing the IOL and its haptics in the sack-like structure formed by the intact posterior and peripheral walls of the lens capsule and compressing the haptics against the periphery of the lens capsule. Alternatively, the IOL can be placed in front of and outside the lens capsule by placing the haptics between the iris and the zonules, in the region of the ciliary sulcus to hold the lens in place. Fixation of the IOL in the anterior chamber is associated with several complications including, hyphema, uveitis, iris chaffing, glaucoma and more, which require more frequent replacements than the posterior chamber lenses.

[0010] While fixation of the IOL to the posterior chamber usually requires adequate zonular or capsular support surgeons have succeeded in implanting IOL in a posterior chamber in the absence of capsular and zonular support by suturing the lens to the sclera of the eye (transscleral suture fixation), at or near the ciliary sulcus, or by iris fixation.

[0011] US patent No. 5336262 describes an IOL suitable for sclera fixation having a disk-shaped lens optic with two flexible haptics projecting outwardly from opposite points on the lens optic’s periphery, each haptic including one or more suture holes for use in suturing the haptic to the ciliary sulcus of the eye during implantation surgery.

[0012] US Patent Application publication No. 20150305855 (US Patent No. 9445891) describes an IOL including a lens and a pair of right and left loop-shaped support portions, and a folding- back portion in the front end of each support portion. A sclera tunnel is formed in the circumferential direction at a position of a depth corresponding to the half of the thickness of the sclera in two symmetrical positions with respect to the visual axis in a portion adjacent to a limbus of the sclera. The front end of the support portion is extracted from the ciliary sulcus and is inserted into the sclera tunnel, so that the IOL is fixed into the eye. At that time, the folding-back portion is hooked to a certain portion inside the sclera tunnel, so that the support portion is strongly restrained inside the sclera tunnel, resulting in an IOL which is more reliably fixed.

[0013] US 5776191 describes a system for fixation of IOL structures without the requirement of sutures and without iris involvement, which comprises a deformable, compliant, peripheral frame and concentrically disposed optical zone portion which is resiliently suspended from the frame by a plurality of compliant fibers or webbing. The system may be utilized for placement of IOS having either a rigid or a deformable optical zone portion in the anterior chamber of posterior chamber of the eye following cataract removal procedures.

[0014] WO2018 / 172897 describes an ophthalmic surgical instrument for securing an IOL comprising: an elongated handle; a first arm, fixedly disposed at a distal end of the handle; and a second arm, pivotably disposed at a distal end of the handle; wherein the distal end of the instrument is configured to be inserted into a corneal incision of the eye and aligned such that an IOL haptic of the IOL, and the iris of the eye, are positioned between the first arm and the second arm, and wherein the second arm is configured to pivot about a transverse axis of the instrument to clasp the IOL haptic and the iris against the first arm, so as to allow the deployment of a fastener to fasten the clasped IOL haptic to the clasped iris. JP patent No. 2792588 describes an IOL which is inserted into the eye and is sutured to a ciliary body for the treatment of the cataract.

[0015] WO 2022 / 079710 describes an ocular clip implant for securing an IOL in the eye which comprises an lOL-engaging portion disposed at a first end of the ocular clip for grasping a portion of the IOL, and an ocular-wall-engaging portion integrated with and disposed at a second end of the ocular clip implant, and comprising an anchor transtionable from a first, straightened configuration to a second, non-straightened configuration to anchor the ocular clip implant to a wall of the eye, in order to secure the IOL to the eye.

[0016] A relatively rare complication of cataract surgeries is an IOL dislocation, which represent about 3% of all cases. Dislocation may present as phacodonesis (trembling) of the lens of the eye), simple decentration (loss of IOL centration within the bag or in the sulcus without zonular or capsular instability), partial subluxation (partial zonular or capsular instability), or complete dislocation of the lens within and outside of the bag, due to total zonular or capsular instability.

[0017] IOL dislocation can occur from various reasons, including technical difficulties during IOL placement (e.g., poor surgical techniques), poor IOL material and / or design, as well as postoperative eye rubbing or trauma. Risk factors affecting IOL instability include, for example, partial or complete weakness the zonular support system, high myopia, intraocular inflammation, intraocular tumors, instability of the capsular bag or pseudoexfoliation (FXF).

[0018] IOL exchange carries a significant risk since it requires a large surgical incision, extraction of an optically fitted IOL, and placing a new IOL that needs to be fixated.

[0019] SUMMARY OF THE INVENTION

[0020] According to an aspect of some embodiments of the present invention there is provided a method of fixation of an intraocular lens (IOL) comprising:

[0021] (a) inserting a fixation tool posterior to the iris;

[0022] (b) grasping the IOL between two flat facing surfaces of a grasper of the fixation tool; and

[0023] (c) anchoring a proximal end of the grasper to a sclera.

[0024] According to an aspect of some embodiments of the present invention there is provided a method of fixation of an intraocular lens (IOL) comprising:

[0025] (a) inserting a fixation tool posterior to the iris;

[0026] (b) grasping the IOL and / or an haptic of the IOL between two facing surfaces of a grasper of the fixation tool;

[0027] (c) anchoring a proximal end of the grasper to a sclera and / or to an outer surface of the sclera, and; (d) adjusting an angle between the grasper and the IOL, between the grasper and the haptic, and / or between the grasper and the inner surface of the sclera.

[0028] According to an aspect of some embodiments of the present invention there is provided an intraocular lens (IOL) fixation tool, comprising:

[0029] (a) an elongate body comprising a trans- scleral element;

[0030] (b) a grasper at a distal end of the body comprising:

[0031] (i) at least two axially extending arms which define flat facing grasping surfaces,

[0032] (ii) means for approximating the arms towards each other so that they grasp.

[0033] According to an aspect of some embodiments of the present invention there is provided an intraocular lens (IOL) fixation tool, comprising: implantable tissue grasper device comprising:

[0034] (i) an implantable grasper, and

[0035] (ii) a bendable elongated body, the bendable elongated body has a proximal end and a distal end, wherein the distal end is connected to the implantable grasper, and wherein the proximal end comprises a barrier having a diameter which exceeds a maximal diameter of the grasper when the grasper is closed.

[0036] According to some embodiments of the invention, the anchoring of the proximal end of the grasper is to an outer surface of the sclera.

[0037] According to some embodiments of the invention, anchoring is performed near or at the sulcus.

[0038] According to some embodiments of the invention, anchoring is performed 1.5-2 mm posterior to limbus.

[0039] According to some embodiments of the invention, the method further comprising adjusting a position of the IOL with the grasper prior to anchoring.

[0040] According to some embodiments of the invention, the method further comprising adjusting an angle between the grasper and the IOL.

[0041] According to some embodiments of the invention, the method further comprising choosing and setting an angle between the grasper and the inner surface of the sclera prior to the anchoring.

[0042] According to some embodiments of the invention, grasping is effected by approximating the two grasping surfaces towards each other.

[0043] According to some embodiments of the invention, prior to the grasping the method comprises changing the configuration of the grasper to an open configuration.

[0044] According to some embodiments of the invention, prior to the grasping the method further comprising: (a) moving the grasping surfaces until the IOL is between the surfaces, and

[0045] (b) activating the grasping surfaces to grasp the IOL.

[0046] According to some embodiments of the invention, the grasping is of an haptic of the IOL.

[0047] According to some embodiments of the invention, grasping is of a lens of the IOL.

[0048] According to some embodiments of the invention, grasping is effected by changing the configuration of the grasper to a closed configuration.

[0049] According to some embodiments of the invention, the method further comprising generating a trans- scleral hole having a diameter sufficient for inserting the fixation tool.

[0050] According to some embodiments of the invention, the method further comprising detaching the proximal end of the grasper from an elongated body of the fixation tool.

[0051] According to some embodiments of the invention, the detaching is effected by diathermia.

[0052] According to some embodiments of the invention, anchoring is to an outer surface of the sclera and is performed by diathermia or a trans-sclera thread.

[0053] According to some embodiments of the invention, the method further comprising identifying an IOL dislocation in a subject prior to the inserting in step (a).

[0054] According to some embodiments of the invention, inserting is through the sclera in a close proximity to the limbus.

[0055] According to some embodiments of the invention, inserting the tool (e.g., the fixation tool) is performed into a posterior chamber of the anterior cavity.

[0056] According to some embodiments of the invention, inserting the tool (e.g., the fixation tool) is performed in or at the cornea.

[0057] According to some embodiments of the invention, inserting the tool (e.g., the fixation tool) is performed in or at the Pars-plana.

[0058] According to some embodiments of the invention, inserting the tool (e.g., the fixation tool) is performed in or at the limbus.

[0059] According to some embodiments of the invention, inserting the fixation tool is performed into the vitreous cavity.

[0060] According to some embodiments of the invention, the method further comprising selecting a position for the inserting based on position of the haptic.

[0061] According to some embodiments of the invention, the grasper has a closed configuration and an open configuration, and wherein a maximal proximity between the two grasping surfaces in the closed configuration is suitable for anchoring the haptic and / or the IOL between the grasping surfaces while minimizing pinching forces. According to some embodiments of the invention, the means for approximating the arms towards each other comprise:

[0062] (i) a tube which surrounds at least a portion of the grasper,

[0063] (ii) a ring which engages the grasper in a locked configuration, and

[0064] (iii) at least one switch for controlling movement of the tube along the elongated body.

[0065] According to some embodiments of the invention, a combined length of the trans- scleral element and the grasper does not exceed 5.2 millimeter (mm).

[0066] According to some embodiments of the invention, a combined length of the trans- scleral element and the grasper does not exceed 3.0 millimeter (mm).

[0067] According to some embodiments of the invention, a maximal diameter of the IOL fixation tool which comprises the grasper in the closed configuration does not exceed 0.6 mm.

[0068] According to some embodiments of the invention, the grasper comprises nitinol or titanium.

[0069] According to some embodiments of the invention, the trans-scleral element comprises a non-degradable biocompatible polymer.

[0070] According to some embodiments of the invention, the bendable elongated body and the barrier comprise a non-degradable biocompatible polymer.

[0071] Unless otherwise defined, all technical and / or scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which the invention pertains. Although methods and materials similar or equivalent to those described herein can be used in the practice or testing of embodiments of the invention, exemplary methods and / or materials are described below. In case of conflict, the patent specification, including definitions, will control. In addition, the materials, methods, and examples are illustrative only and are not intended to be necessarily limiting.

[0072] BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING(S)

[0073] Some embodiments of the invention are herein described, by way of example only, with reference to the accompanying drawings or images. With specific reference now to the drawings in detail, it is stressed that the particulars shown are by way of example and for purposes of illustrative discussion of embodiments of the invention. In this regard, the description taken with the drawings makes apparent to those skilled in the art how embodiments of the invention may be practiced.

[0074] In the drawings: FIG. 1 A is a flow chart of a method of fixation an IOL according to some embodiments of the invention;

[0075] FIGs. 1B-H are representative tools (100) for fixation or manipulation of an intraocular object, e.g., an IOL according to some embodiments of the invention;

[0076] FIGs. 2A-H are representative flow charts of a method of fixation an IOL according to some embodiments of the invention. Fig. 2 A depicts a detailed view of a fixation of an IOL according to some embodiments of the invention. Fig. 2B depicts inserting at least the grasper of the fixation tool into the eye according to some embodiments of the invention. Fig. 2C depicts grasping the IOL or an haptic of the IOL according to some embodiments of the invention. Fig. 2D depicts grasping the IOL or the haptic of the IOL with the jaws according to some embodiments of the invention;

[0077] FIGs. 3A-F are schematic illustrations of an IOL fixation tool in a closed configuration according to some embodiments of the invention;

[0078] FIGs. 4A-B are schematic illustrations of an IOL fixation tool in an open configuration according to some embodiments of the invention;

[0079] FIGs. 5A-D are schematic illustrations of an IOL fixation tool in a locked configuration according to some embodiments of the invention;

[0080] FIG. 6 is a general flow chart of a method of fixation an IOL according to some embodiments of the invention;

[0081] FIG. 7 is a schematic illustration of IOL and part of an IOL fixation tool according to some embodiments of the invention;

[0082] FIGs. 8A-C are schematic illustrations of an implanted grasper within the eye according to some embodiments of the invention;

[0083] FIGs. 9A-D are schematic illustrations of an IOL fixation tool according to some embodiments of the invention;

[0084] FIGs. 10A-H are schematic illustrations of an IOL fixation tool according to some embodiments of the invention;

[0085] FIGs. 11A-E are schematic illustrations of manufacturing and / or assembly of an IOL fixation tool according to some embodiments of the invention;

[0086] FIGs. 12A-G are schematic illustrations of an implantable part of an IOL fixation tool according to some embodiments of the invention;

[0087] FIGs. 13A-G are schematic illustrations of an IOL fixation tool according to some embodiments of the invention; FIGs. 14A-C are schematic illustrations of an IOL fixation tool according to some embodiments of the invention; and

[0088] FIG. 15 is a general flow chart of a method of fixation or manipulation of an IOO according to some embodiments of the invention.

[0089] DESCRIPTION OF SPECIFIC EMBODIMENTS OF THE INVENTION

[0090] The present invention, in some embodiments thereof, relates to methods of grasping an intraocular object (IOO) such as an intraocular lens (IOL) within the eye, and, more particularly, but not exclusively, to a tool useful for IOL fixation.

[0091] Overview

[0092] An aspect of some embodiments of the invention relates to grasping an IOO, such as an IOL or a part thereof, within the eye. According to some embodiments of the invention, grasping the IOO is performed with a tool designed to reduce the risk of damaging the IOO and / or the eye. According to some embodiments of the invention, the method relates to grasping the IOO and fixing it within the eye. According to some embodiments of the invention, the method relates to implanting the IOO within the eye. According to some embodiments of the invention, the method relates to grasping an IOO within the eye and removing it from the eye. According to some embodiments of the invention, the method relates to grasping an IOL and implanting it within the eye.

[0093] According to some embodiments of the invention, the IOO is a tissue or an object within the eye. According to some embodiments of the invention, the IOO is an intraocular optic such as an intraocular lens (IOL), an intraocular telescope, and / or an intraocular microscope. According to some embodiments of the invention, the IOO is an intraocular tissue, or a device that can be grasped by jaws of the grasper of some embodiments of the invention. According to some embodiments of the invention, the IOO is a foreign (e.g., exogenous) body within the eye. According to some embodiments of the invention, the IOO is an IOL. According to some embodiments of the invention, the IOL mimics the structure and function of a natural lens of an eye.

[0094] Typically, the IOL comprises an optically active synthetic element (a lens) and at least one haptic (an appendage of the IOL), usually 2 haptics, connected thereto, which are designed to hold the IOL in a proper place within the eye.

[0095] According to an aspect of some embodiments of invention, the tool has an implantable portion which comprises a grasper and a flexible (e.g., bendable) strand. An aspect of some embodiments of the invention relates to a grasper with two jaws with facing surfaces and which are suitable for grasping an IOO there-between. According to some embodiments of the invention the two facing surfaces do not cross each other. According to some embodiments, the two surfaces are flat. According to some embodiments, the two facing surfaces comprise teeth along at least a portion thereof. According to some embodiments, the two facing surfaces are parallel to each other. According to some embodiments, the two facing surfaces are not parallel to each other but yet they do not cross each other. According to some embodiments, the geometry of the two facing surfaces depends on the IOO to be grasped by the grasper.

[0096] According to some embodiments of the invention, grasping is of an IOL which has only one haptic connected thereto. According to some embodiments of the invention, grasping is of an IOL which has no haptic connected thereto.

[0097] Various configurations of haptic positions with respect to the center of the IOL are available, for example, an IOL optionally has two haptics at a 180° interval. According to some embodiments of the invention, grasping is of an IOL having two haptics at a 180° interval.

[0098] The grasper of some embodiments of the invention can grasp, for example, rigid, soft, long or short haptics.

[0099] Typically, the IOL is generally planar, and the haptic is generally planar. There is a plane of the IOL which is generally perpendicular to the optical axis of the IOL. Typically, the surface which parallels the mid line between the jaws, while in the closed configuration, is generally planar and continuous with the plane of the base controlling the jaws. According to some embodiments, the grasper can hold the IOL such that the planar surface between the jaws overlaps with the plane of the haptic or of the IOL.

[0100] According to some embodiments, grasping is effected with two graspers which hold an IOL having two haptics at a 180° interval.

[0101] According to an aspect of some embodiments of the invention, the implantable grasper is made of a material which is compatible for implantation within an eye (e.g., a bio-compatible material). Optionally, the material (and implanted part of grasper) is non-metallic, for example, being formed of a polymeric material, such as plastic or silicone. According to some embodiments of the invention, the implantable grasper has a shape that is designed to minimize unintentional damage to the eye. According to some embodiments of the invention, the implantable grasper is ocular-safe.

[0102] According to some embodiments of the invention the flexible strand can be anchored to the sclera while allowing adjustment of the angle between the IOO and the sclera prior to final fixation of the IOO within the eye. According to some embodiments of the invention the flexible strand can be anchored to the sclera while allowing adjustment of the angle between the IOO and the grasper prior to final fixation of the IOO within the eye. According to some embodiments of the invention the flexible strand can be anchored to the sclera while adjusting the angle between an IOL and a haptic connected thereto. According to some embodiments of the invention the flexible strand can be anchored to the sclera while adjusting the angle between the longitudinal axis of the grasper and the plane which is tangent to the sclera at the point where the grasper passes from the sclera into the eye. This can happen, for example, if one side of the IOL is grasped and anchored while a second side is being manipulated.

[0103] According to some embodiments of the invention, the flexible strand is anchored to the sclera by applying diathermia and creating a suture with a diathermia dome. Anchoring via diathermia has several advantages, including, but not limited to, reducing irritation to the ocular tissue, being minimally invasive and standard to use.

[0104] The grasper can be in an open configuration for fishing around for an IOO within the eye, in a closed configuration while inserting the grasper into the eye and while grasping the IOO, or in a locked configuration after grasping the IOO, such as for permanently fixing the position or the relative orientation of the IOO within the eye.

[0105] According to some embodiments of the invention, opening or closing of the grasper is achieved by controlling the position of a sheath that surrounds the jaws of the grasper, along a longitudinal axis of the grasper. Optionally, a ring may be used for such control and / or be used to permanently lock the grasper in a locked, closed position.

[0106] According to some embodiments of the invention, while in a closed configuration there is a space between the two facing surfaces which is suitable for grasping the IOO.

[0107] According to some embodiments of the invention while in a locked configuration there is a minimal space between the two facing surfaces which is suitable for permanently grasping the IOO between the two surfaces while minimizing damage to the IOO.

[0108] An aspect of some embodiments of the invention relates to locking of jaws of an intraocular grasper using an axially advanceable locking ring. According to some embodiments of the invention, locking is achieved by advancing the locking ring in a distal direction of the jaws until the locking ring reaches a step or other geometry which interferes with the ring from moving back in the proximal direction.

[0109] In some embodiments of the invention, a safety pin (also referred to as a “locking pin” below) is provided which prevents the locking ring from advancing to a locking position until the safety pin is moved or removed (e.g., but being pulled with a suture). According to an aspect of some embodiments of the invention, grasping is effected by approximating the jaws towards each other, e.g., by approximating the facing surfaces towards each other.

[0110] An aspect of some embodiments of the invention relates to anchoring grasper or other tool in the eye, to the sclera or other external structure, using a flexible joint optionally created by a flexible suture (e.g., in the form of a thread). This can allow the attachment to be rotationally flexible, allowing the grasper to be positionally anchored to the sclera, while able to be at various angles to the sclera. This can provide flexibility in choosing an insertion location (across the sclera) for the grasper, as the angle of access to the IOL is not as strictly limited by the desired grasping location, and there is potentially more freedom in the final IOL location in view of scleral passage location.

[0111] An aspect of some embodiments of the invention relates to the provision of a grasper which can be operated in a manner similar to other ocular surgical tools, with an additional activation option of locking the grasper and a further activation option of releasing the grasper from the tool so it may remain in the eye, optionally anchored. A particular feature of some embodiments of the invention is that the tool has a small diameter (e.g., between 0.48 and 1.5 mm), potentially allowing a standard or no cannula to be used and / or reducing damage to the eye.

[0112] Before explaining at least one embodiment of the invention in detail, it is to be understood that the invention is not necessarily limited in its application to the details of construction and the arrangement of the components and / or methods set forth in the following description and / or illustrated in the drawings and / or the Examples. The invention is capable of other embodiments or of being practiced or carried out in various ways.

[0113] Referring now to the Drawings.

[0114] Figure 1A provides a general view of a method of fixating an IOL within the eye. Optionally, prior to fixating the IOL within the eye, at 102, identifying an IOL dislocation in a subject, e.g., in a wrong position and / or angle with respect to the iris and / or with respect to the sclera; or identifying an insufficient support for the IOL.

[0115] Various methods of identifying an IOL dislocation are known in the art and some of them are described herein under. For example, an IOL dislocation can be identified by a clinical examination in a slit ophthalmic microscope or by an imaging tool such as fundus photography, anterior segment photography, anterior segment OCT, ocular ultrasound and ocular CT / MRI. Following are some examples of disorders that may be repaired using a grasper and / or methods as described herein. A subject with IOL dislocation may suffer from pseudoexfoliation (PXF), trauma to the eye or myopia.

[0116] According to some embodiments of the invention, the IOL dislocation is characterized by phacodonesis of the lens of the eye.

[0117] According to some embodiments of the invention, the IOL dislocation comprises decentration.

[0118] According to some embodiments of the invention, the IOL dislocation is a partial subluxation.

[0119] According to some embodiments of the invention, the IOL dislocation is a complete dislocation of the lens within and outside of the bag, due to total zonular or capsular instability.

[0120] In some embodiment the tool according to some embodiments of the invention is superior in fixing an IOL in any of the above dislocation conditions since it does not require a suture as required by the prior art techniques.

[0121] Once establishing that the IOL is in a wrong location (e.g., dislocation), the method comprises a step of adjusting the position and / or angle of the IOL within the eye. At 104, the method comprises inserting a fixation or a manipulation tool to the eye. Exemplary components of the fixation or manipulation tool are described in a schematic form in Figures 1B-1H, which is described hereinunder.

[0122] Once the fixation or manipulation tool is inserted into the eye, at 106, the method comprises positioning the IOL in a desired location within the eye, which is performed by grasping the IOL or the haptic of the IOL (termed “haptic” hereinunder) by the grasper.

[0123] Then, at 108, retaining the grasper which holds the IOL and / or the haptic within the eye, while separating the proximal end of the fixation tool from the grasper and removing it outside of the eye.

[0124] Figure IB describes tool (100) for fixation or manipulation of an IOL. Tool (100) comprises jaws (120) for grasping an IOL or a haptic between them. Tool (100) has a small diameter, e.g., tool (100) optionally has dimensions which can fit through a trans-scleral hole.

[0125] According to some embodiments of the invention the diameter of tool (100) while in a closed configuration, is between 0.48-1.5 mm. According to some embodiments of the invention the diameter of tool (100) while in a closed configuration is between 0.48 and 1 mm. According to some embodiments of the invention the diameter of tool (100) while in a closed configuration is about 0.48 mm.

[0126] According to some embodiments of the invention the length of the implantable grasper of tool (100) is between 0.5-5 mm. According to some embodiments of the invention the length of the implantable grasper of tool (100) is up to 4 mm. According to some embodiments of the invention the length of the implantable grasper of tool (100) is up to 3.5 mm. According to some embodiments of the invention the length of the implantable grasper of tool (100) is up to 3.0 mm. According to some embodiments of the invention the length of the implantable grasper of tool (100) is up to 2.5 mm.

[0127] Jaws (120) are for grasping and holding an intra-ocular object there-between, e.g., jaws (120) can grasp the IOL or the haptic there-between. Jaws (120) optionally comprise two facing surfaces which are capable of grasping an IOL or an haptic by approximating the jaws towards each other. According to some embodiments of the invention, jaws (120) are flat facing surfaces.

[0128] As used herein the phrase “facing surfaces” refers to two surfaces which generally face each other, for example, the two surfaces can be attached to a pivot point and move towards each other.

[0129] As used herein the phrase “flat surface” is a surface that is planar, meaning that it has a consistent, even plane with minimal deviation. While some deviation may be allowed, especially for teeth or other protrusions for increasing friction, or for holes, or for rounding at edges, the surface (or a geometrical surface tangent to the projection, if any) defines a flat plane. A jaw may have several flat surfaces and / or include a curved surface section. In some embodiments of the invention, a jaw includes a flat surface covering at least 50% of the area intended for contacting an IOO on a jaw. Both jaws may be flat with matching flat sections. It is noted that for some IOOs a non-flat surface may be preferred.

[0130] Jaws (120) optionally have teeth along at least part of their surface to assist in grasping the IOL and / or the haptic. Jaws (120) optionally have a blunted tip to reduce the risk to damage tissue within the eye. Jaws (120) optionally have a segment which, when the jaws approximate towards each other the two parallel segments close against each other and maintain the same distance between the surfaces along the entire length of the segments, in order to reduce potential crushing forces on the intraocular object grasped by the jaws.

[0131] In some embodiments jaws (120) are configured to be in one of the following configurations: open, closed or locked configurations.

[0132] Jaws (120) are in an open configuration when searching for an haptic or an IOL, and in a closed configuration before or after gasping the IOL or the haptic. Jaws (120) are in a locked configuration after grasping the haptic or the IOL. When in a closed or locked configuration jaws (120) do not apply enough pressure to damage the IOO there-between. In some embodiments, tool (100) is selected according to the sensitivity of the IOO being manipulated. Tool (100) optionally comprises a mechanism (122) for opening, closing and / or locking jaws (120), e.g., described in Figure IF. Tool (100) optionally comprises an anchor (124) for anchoring jaws (120) while in the locked configuration within the eye, (e.g., as described in Figures IB and 1C).

[0133] Anchor (124) has a proximal end which is designed to be at the outer surface of the sclera and a distal end attached directly or indirectly to jaws (120). For example, indirect attachment of jaws (120) with anchor (124) can be by strand (127) (e.g., described in Figure 1C).

[0134] Tool (100) optionally comprises mechanism (126) for detaching anchor (124) from the remaining proximal end of strand (127) which is outside of the sclera (e.g., as described in Figure 1C).

[0135] Detachment of the anchor from the remaining proximal end of strand (127) can be performed by various methods such as diathermia or mechanical detachment. Such methods are schematically described in Figures 2F, 2G and 2H.

[0136] According to some embodiments of the invention, anchor (124) is formed after / during detaching, from the strand. According to some embodiments of the invention, anchor (124) is shaped and composed of a material that will not cause significant inflammation or mechanical interference with eye movement.

[0137] Optionally, when jaws (120) remain within the eye part of strand (127) crosses the sclera, and from its tip anchor (124) may be formed.

[0138] Figure 1C depicts tool (100) for fixating or manipulation of an IOL within the eye, in which strand (127) is attached to anchor (124). Strand (127) can be flexible, e.g., bendable. Once the anchor is formed, the distance between jaws (120) and the sclera depends on the length of strand (127). The remainder strand (157) which is proximal to the anchor can be detached from anchor (124) after fixation of the IOL within the eye. Strand (127) can be connected to mechanism (122) (e.g., described in Figure IF) and / or to mechanism (126).

[0139] In some embodiments of the invention, mechanism (126) is attached to anchor (124) and / or to remainder strand (157) for detaching anchor (124). In some embodiments of the invention, mechanism (122) can open jaws (120). In some embodiments of the invention, mechanism (122) can close jaws (120). In some embodiments of the invention, mechanism (122) can lock jaws (120).

[0140] Figure ID depicts grasper (125) which can be part of fixation tool (100). Grasper (125) includes jaws (120) and base (133). Grasper (125) can be operated like standard forceps, by approximating jaws (120) towards each other. Grasper (125) can be implantable within the eye. According to some embodiments, grasper (125) is implantable posterior to the iris within the eye. According to some embodiments, grasper (125) is bio-compatible. According to some embodiments of the invention, the grasper (125) has a shape that is designed to minimize unintentional damage to the eye. According to some embodiments of the invention, grasper (125) is ocular-safe.

[0141] Base (133) controls opening and closing of jaws (120). Base (133) comprises joint(s) (described in Figure 1G) which allow(s) jaws (120) to open. Base (133) also maintains jaws (120) connected to fixation tool (100).

[0142] Figure IE depicts tool (100) following detachment of remainder strand (157) from the proximal end of anchor (124). Optionally, barrier (128) is formed at the proximal end of the trans- scleral element (105). According to some embodiments of the invention, barrier (128) is a deployed element, e.g., a locking bead. Barrier (128) can be configured such that it is unable to enter the trans-scleral hole. Barrier (128) optionally has a dome shape, e.g., such as a dome formed by diathermia. According to some embodiments the largest diameter of the dome shape of barrier (128) exceeds the diameter of the trans-scleral hole. Barrier (128) optionally has a shallow dome shape, wherein the largest diameter of the shallow dome shape exceeds the diameter of the trans- scleral hole.

[0143] According to some embodiments of the invention, barrier (128) has a diameter between 0.6-2.0 mm. According to some embodiments of the invention, barrier (128) has a diameter which is larger than 1.5 mm, but not exceeding 2.0 mm.

[0144] According to some embodiments of the invention, barrier (128) comprises a nonabsorbable suture.

[0145] Figure IF depicts an exemplary mechanism (122) for controlling jaws (120) which can be used according to some embodiments of the invention. Mechanism (122) comprises over-tube (350), shaft (355), and base (133). Over-tube (350) covers at least part of jaws (120). Shaft (355) holds strand (127). Base (133) comprises hole (340). Hole (340) allows room for movement of proximal ends of jaws (120) while opening. Optionally, mechanism (122) also comprises ring (330) which maintains jaws (120) in a locked configuration.

[0146] In some embodiments, e.g., as shown in Figure 1G, shaft (355) comprises fingers (329) at a distal end thereof, which can apply force towards the middle of strand (127) in order to frictionally engage the strand and prevent premature release of the grasper. Optionally or additionally, the fingers define a geometry which geometrically interferes with pulling back of the fingers axially from the grasper. The strand, between the fingers may serve to prevent elastic deformation of the fingers in a way which will allow such pulling back of the fingers. In addition, base (133) can optionally comprise joint (323), which allows opening of jaws (120) within hole (340). Joints (323) optionally have protrusion (359) at a proximal end thereof to which finger (329) can fit. When over-tube (350) is advanced in a distal direction of tool (100) (towards the inner part of the eye) it forces fingers (329) to fit into protrusion (359) in joints (323).

[0147] Figure 1H depicts exemplary configurations of fixation tool (100).

[0148] At 129, when inserting tool (100) into the eye tool (100) has jaws (120) in a closed configuration, to fit a trans-scleral hole. At 129, facing surfaces (e.g., flat facing surfaces) of jaws (120) are in close proximity to each other with a minimal space between the flat facing surfaces;

[0149] At 130, e.g., when searching for an haptic or an IOL, jaws (120) are in an open configuration, with a relatively large distance between jaws (120) (e.g., between the two flat facing surfaces of the jaws);

[0150] At 132, once the haptic or the IOL is within the space formed by jaws (120), the two jaws (120) approximate towards each other until they reach a closed configuration in which there is a minimal distance between the surfaces of the jaws which on one hand holds the IOL or the haptic between the surfaces, and on the other hand, prevents introducing detrimental forces on the IOL or the haptic;

[0151] At 134, jaws (120) are in a locked configuration. Jaws (120) already grasped the haptic and / or the IOL between the facing surfaces of the jaws.

[0152] At 136, tool (100) is anchored to the sclera and the remainder part (i.e., on the proximal end) of tool (100) is detached.

[0153] Referring now to Figures 2A-I which provide a more detailed view of a method of fixating an IOL according to some embodiments, e.g., as described in Figures 1A-H.

[0154] According to some embodiments, the method is effected using a surgical microscope or another magnification tool used for imaging the eye during surgery.

[0155] Optionally, prior to fixating the IOL, at 102, the method comprises identifying an IOL dislocation in a subject (as explained hereinabove).

[0156] Then, once a dislocation of IOL is identified, at 202, the method comprises deciding how to access the eye. Optionally, determination of the right place to access the eye depends on the position of the IOL and / or the haptic, presence or absence of haptics, and access angle while trying to reduce risk of damaging tissue within the eye. In some embodiments, the access points are determined by placement of trocars for vitreoretinal surgery in the generally accepted position (e.g., 2.0-4.0 mm posterior to the limbus) as part of the vitrectomy surgery usually indicated in these cases. Alternatively the fixation device (tool (100)) may be used independently and not as part of vitrectomy surgery (e.g., insertion of a fixation tool or to reposition and centralize a subluxated IOL) either through a sclerotomy or a trocar. It is a potential advantage of some embodiments of the invention that vitrectomy may be avoided when using the instant grasping tool for IOL fixation. In such uses, a single access opening through which only one tool is inserted may be sufficient for IOL fixation / repositioning. A potential advantage of flexible anchoring using a flexible strand is that after anchoring the grasper can be at a wide range of angles relative to the sclera. This means that the angle used for inserting the grasper into the eye need not be the final angle of the grasper when implanted, diverging, for example, by between 10 and 80 degrees, for example, between 40 and 60 degrees from perpendicular to the sclera.

[0157] Once the access point is determined, at 204, the method comprises inserting grasper (125) of the fixation tool (100) into the eye (e.g., as shown in Fig. 2B and described herein below). In some embodiments, mechanism (122) which opens and closes jaws (120) is not inserted into the eye. In some embodiments mechanism (122) for opening and closing jaws (120) is located on the handle which is external to the eye.

[0158] Referring now to Figure 2B which describes optional steps of inserting at least grasper (125) of the fixation tool into the eye.

[0159] Optionally, prior to inserting the grasper (125), at 206, the method comprises generating a trans- scleral hole.

[0160] Various methods can be used to generate the trans-scleral hole.

[0161] For example, reference 208 refers to generating the trans-scleral hole by inserting a Trocar through the sclera. According to some embodiments, the trocar is inserted into the posterior chamber of the anterior cavity. According to some embodiments, the trocar is inserted into the sulcus / lens zonular plane. According to some embodiments of the invention, fixation or manipulation tool (100) is inserted either using a trocar placed 1-3 mm posterior to the limbus or through a small sclerotomy in the same region.

[0162] In some embodiments, the manipulation or fixation of an IOO is performed in addition to another surgical procedure within the eye. In such cases, the trocar(s) are placed as above (e.g., 1- 3 mm posterior to the limbus), and once the additional surgical procedure is completed through the trocars then tool (100) is inserted (deployed) through the trocar(s).

[0163] For example, reference 210 refers to generating the trans-scleral hole by inserting a needle (e.g., a 27 gauge (G) needle) through the sclera. According to some embodiments, the needle is inserted to the sulcus through the sclera 1-3 mm posterior to the limbus. A potential advantage of using a needle is that the grasper can be inserted through the hole made by the needle and an external cannula avoided. This may reduce trauma to the eye. Alternatively, a cannula (e.g., a trocar) may be inserted and the grasper delivered through such cannula. Additionally or alternatively, the trans-scleral hole (sclerotomy) can be generated using a laser or a sharp knife or a scalpel (e.g., MVR blade, stiletto blade).

[0164] According to some embodiments of the invention, the trans-scleral hole (sclerotomy) has a diameter which is sufficient for inserting at least grasper (125) of the fixation tool there through while being in a closed configuration. For example, the diameter of the trans-scleral hole can be in the range of 0.4-2.0 millimeter (mm), e.g., between 0.48-1.5 mm, e.g., 0.48-0.6 mm, e.g., 0.48- 0.5 mm.

[0165] According to some embodiments of the invention, the trans-scleral hole is sealed by anchor (124) and / or barrier (128).

[0166] According to some embodiments of the invention, grasper (125) is inserted through a hole generated by a needle. According to some embodiments of the invention, the hole is self-sealed on a suture (e.g., the strand or filament used for anchoring the grasper, for example, as described herein).

[0167] According to some embodiments of the invention, grasper (125) of the fixation tool is inserted at a position posterior to the iris.

[0168] The area posterior to the iris includes the posterior chamber of the anterior cavity, which is the space between the iris and the lens of the eye, filled with aqueous humor, as well as the vitreous chamber, which is filled with vitreous humor.

[0169] According to some embodiments of the invention, grasper (125) is inserted into a cavity or chamber filled with aqueous humor or vitreous humor. According to some embodiments of the invention, the grasper can be used to both anterior and posterior segments operations.

[0170] According to some embodiments of the invention, inserting grasper (125) of the fixation tool is effected into a posterior chamber of the anterior segment, e.g., near or at the sulcus.

[0171] According to some embodiments of the invention, inserting grasper (125) of the fixation tool is effected through the sclera in a close proximity to the circumferential of the limbus in the direction of the back of the eye. For example, accessing the sclera is effected about 1-3 mm from the circumferential of the limbus in the direction of the back of the eye, e.g., about 1-2 mm, preferably about 1.5 mm.

[0172] According to some embodiments of the invention, inserting grasper (125) is effected through the sclera in a distance selected from 1.5 mm to 2 mm from the circumferential of the limbus in the direction of the back of the eye.

[0173] According to some embodiments of the invention, a clock-wise position of entry through the sclera may depend, for example, on the position and / or angle of the IOL, the choice and comfort of the surgeon performing the surgery, the desired final angle and position of the fixated

[0174] IOL, and the ease of surgical access as is further described herein.

[0175] Once the trans-scleral hole / sclerotomy is generated, grasper (125) of the IOL fixation tool can be inserted directly.

[0176] According to some embodiments of the invention, inserting the IOL fixation tool does not involve accessing the cornea and / or the limbus. It is noted that the grasper as described herein can have a low cross-sectional diameter, so even if inserted at such locations, may cause less damage than other methods.

[0177] Optionally, at 212, the method comprises inserting the IOL fixation tool into an intraocular cannula that fits into the trans-scleral hole (e.g., generated by the trocar).

[0178] At 214, the method comprises inserting at least the distal end of the fixation tool which comprises the grasper into the eye.

[0179] Returning now to Figure 2A. At 216, the method comprises grasping the IOL and / or a haptic (e.g., as further described in Figs. 2C-2D).

[0180] Referring now to Figure 2C. Figure 2C describes exemplary steps of grasping the IOL or the haptic:

[0181] At 218, the method comprises opening jaws (120) of grasper (125).

[0182] At 220, the method comprises opening jaws (120) of grasper (125), optionally by releasing jaws (120) from over-tube (350) and switching grasper (125) into an open configuration. This can be performed for example by retracting tube (350) which covers part of grasper (125) towards the exterior part of the sclera so as to release jaws (120) from over-tube (350) and to switch grasper (125) into an open configuration.

[0183] At 222, the method comprises fishing around for the IOL or haptic. Optionally, fishing around is performed using a surgical microscope or other magnification tool used for imaging the eye during surgery; and

[0184] Once jaws (120) find the haptic or the IOL, at 224, the method comprises grasping the IOL or the haptic with jaws (120) (e.g., as described in Figure 2D).

[0185] Figure 2D describes an example of grasping the IOL or the haptic with jaws (120). At 226, the method comprises advancing over-tube (350) over jaws (120) by pushing over-tube (350) towards the interior part of the sclera so that it closes jaws (120) of grasper (125).

[0186] At 227, the method comprises engaging ring (330) over jaws (120) so that they stay locked even when over-tube (350) is further retracted.

[0187] Returning now to Figure 2A. Once the IOL or the haptic is grasped between jaws (120) of grasper (125), at 228, the method comprises positioning the IOL in the right position and / or orientation in the eye (e.g., as described in Fig. 2E). Optionally, the method comprises repositioning to the correct position and / or orientation.

[0188] Figure 2E describes exemplary method steps for positioning the IOL in the right position.

[0189] At 230, manipulating jaws (120) such that the IOL is in the right position.

[0190] At 232, checking if the IOO (e.g., IOL) is indeed in a correct position and / or angle with respect to the cornea. Optionally, checking if the IOO is in a correct position and / or angle with respect to the inner surface of the sclera.

[0191] At 232, if the answer to the question is “Yes”, i.e., the IOO (e.g., the IOL) is indeed in the right position, then the method comprising the step of fixing the grasper so that the IOO remains in the right position. Non-limiting options for fixing the IOO in the right position within the eye are described in Figures 2F-H (e.g., flow-charts 240, 245 or 250).

[0192] At 232, if the answer to the question is “No”, i.e., the IOO is not in the right position, then the method optionally comprises reference 234, adjusting position and / or angle of grasper (125) with respect to the cornea. Optionally, at 234, the method comprises adjusting position and / or angle of grasper (125) with respect to the inner surface of the sclera.

[0193] In some embodiments of the invention, adjusting position and / or angle of grasper (125) is performed by opening grasper (125) and re-grasping the IOO in a new position / angle. In some embodiments of the invention, adjusting position and / or angle of grasper (125) is performed by moving the grasper (while in a closed configuration with the already grasped IOO in-between the jaws) to a new position or angle.

[0194] According to some embodiments, adjusting the position and / or angle is performed using a robotic manipulation. In some embodiments, robotic manipulation such as ORA system (Alcon, Geneva, Switzerland) can be used to adjust the position and / or angle.

[0195] As mentioned, if the IOL is in the right position then the grasper (125) is fixated such that the lens of the IOL which is directly or indirectly (e.g., via the haptic) connected thereto remains in the right position.

[0196] Exemplary option I (flow chart 240, described in Figure 2F) comprises at 242, attaching the proximal end of grasper (125) or the proximal end of a trans-scleral element (105) to the sclera or to the outer surface of the sclera.

[0197] At 244, detaching the proximal end of the remainder strand (157) from the proximal end of grasper (125) or from the proximal end of the trans-scleral element (105).

[0198] Exemplary option II (flow chart 245, described in Figure 2G) comprises at 246, detaching the proximal end of the remainder strand (157) from the proximal end of grasper (125) or from the proximal end of the trans-scleral element (105). At 248, attaching the proximal end of grasper (125) or trans-scleral element (105) to the sclera or to the outer surface of the sclera.

[0199] In some embodiments, mechanical detachment is performed using a surgical tool. Nonlimiting examples of surgical tools designed for cutting surgical threads or sutures include scissors with a sharp, pointed tip that is designed to easily cut through the thread without damaging the surrounding tissue, and any sharp object not touching the sclera or conjunctive.

[0200] Exemplary option III (flow chart 250, described in Figure 2H) comprises forming anchor (124) while fixing grasper (125). For example, at 252, applying diathermia in a close, yet safe, proximity to the proximal end of the fixation tool (e.g., strand (127) of fixation tool (100)) in a level sufficient to detach remainder strand (157) which is proximal to the anchor from the trans- scleral element (105).

[0201] Optionally at 254, applying tense on strand (127) (in a direction outside of the eye) prior to or concomitantly with applying the diathermia.

[0202] Then, at 256, removing the remainder of strand (157), while the retaining grasper (125) with barrier (128) at the proximal end thereof which forms anchor (124) that prevents movement of grasper (125) within the eye.

[0203] Means for employing diathermia include, but are not limited to, electrical current heated devices, use of any external thermal / heated devices, or laser heated devices.

[0204] Referring now to Figures 3A-F which describe an IOL fixation tool according to some embodiments of the invention while in a closed (Figures 3A-C) or a locked (Figures 3D-F) configuration for insertion into a trans-scleral hole and / or into an intraocular cannula within the trans-scleral hole. Figure 3B is a transparent view of the opaque image of Figure 3 A. Figure 3C is a cross-sectional view of the image shown in Figure 3B. IOL fixation tool (300) comprises strand (327) covered by shaft (355) (shown in brown), which is covered by tube (350) (shown in yellow). Tool (300) further comprises grasper (325) (an example of grasper 125) in a closed configuration which comprises jaws (320) in close proximity to each other, hole (340), and base (333). Tool (300) further comprises ring (330). While in the closed configuration ring (330) is located distally to hole (340). Jaws (320) optionally comprise step (311) which fits the size of ring (330) and is configured to prevent movement of ring (330) in the proximal direction while in the locked configuration as is further described in Figures 3D-F and Figures 5A-D.

[0205] Shaft (355) maintains grasper (325) in a closed configuration in which jaws (320) are in a close proximity to each other. Figure 3C shows shaft (355) which comprises fingers (329) held by base (333). Over-tube (350) controls if jaws (320) will be open or closed by employing force on shaft (355) which can close jaws (320), e.g., by pushing fingers (329) into protrusion (359) in base (333).

[0206] Figure 3D describes tool (300) in a locked configuration. Figure 3E is a cross section view of the tool shown in Figure 3D. Figure 3F is a magnification of part of tool (300) showing how interior protrusion (336) of ring (330) can be inserted into the cleft form by step (311) of jaws (320) and preventing ring (330) from moving in the proximal direction, according to some embodiments.

[0207] Figures 4A-B describe the fixation tool (300) according to some embodiments of the invention as described in Figure 3A-F yet in an open configuration, when searching for the IOO (e.g., the haptic or the IOL) within the eye. Figure 4B is a transparent view of the opaque image shown in Figure 4A. IOL fixation tool (300) comprises strand (327), tube (350), shaft (355), ring (330) and grasper (325). While in an open configuration of tool (300) strand (327) is partially covered by tube (350) (shown in yellow) and shaft (355) (shown in brown). Grasper (325) comprises jaws (320) and hole (340). Jaws (320) are elastically predisposed to be open. Grasper (325) is in an open configuration in which jaws (320) are spaced apart from each other. Hole (340) is designed such that it allows room for movement of jaws (320) when jaws (320) are spaced apart from each other to form an open configuration. It is noted that the distal end of shaft (355) is located more proximal to ring (330). Shaft (355) is positioned such that it does not prevent jaws (320) from elastically opening. Ring (330) is currently positioned more proximal to hole (340) and thus does not lockjaws (320) in a locked position.

[0208] Figures 5A-D describe the fixation tool according to some embodiments of the invention as described in Figure 3A-F yet in a locked configuration after grasping the IOL and / or an haptic and while disconnecting the shaft from the grasper. Fixation tool (300) comprises grasper (325) with jaws (320) that are shown in a closed configuration, wherein jaws (320) are held in a close proximity to each other.

[0209] Ring (330) is located distally to hole (340).

[0210] Figure 5B shows fixation tool (300) in which shaft (355) covers part of strand (327) and tube (350) covers part of shaft (355). In Figure 5B fingers (329) of shaft (355) are released from the hold of base (333). By comparing Figures 5A-D (when the fixation tool is in a locked configuration) to Figures 3 A-C (when the fixation tool is in a closed configuration) it is noted that the position of ring (330) in the locked configuration is more distally with respect to hole (340) than ring (330) with respect to hole (340) in the closed configuration. In Figures 5A-D, ring (330) maintains grasper (325) in a locked configuration. According to some embodiments of the invention, step (311), which is visible in Figure 4B, is designed such that once ring (330) is advanced in the distal direction of fixation tool (300) it passes step (311) and step (311) geometrically interferes with proximal motion of ring (330). According to some embodiments of the invention, once ring (330) passes step (311) the grasper (325) is in a locked configuration.

[0211] Figure 5C shows IOL fixation tool (351) after retracting tube (350) (shown in Figures 5A and 5B) and before detaching the proximal end of strand (327). IOL fixation tool (300) comprises strand (327), grasper (325) and ring (330) which holds grasper (325) in a locked configuration.

[0212] Figure 5D shows IOL fixation tool (351) which comprises element (305), barrier (328) and grasper (325). Element (305) fits into the trans-scleral hole used to insert IOL fixation tool (350), and connects to barrier (328) at the proximal end and to grasper (325) at the distal end thereof. Barrier (328) can be formed by a trans-scleral element (e.g., 305), by applying diathermia thereto. When formed by diathermia, barrier (328) has a dome-shape or ball-shape with a diameter larger than the diameter of a trans-scleral hole which is used for inserting the IOL fixation tool to the eye.

[0213] Element (305) optionally comprises a clinically-approved intraocular material (e.g., such as by the FDA). According to some embodiments of the invention, element (305) comprises a non- degradable biocompatible polymer.

[0214] As used herein the phrase “biocompatible polymer” refers to a non-toxic polymer which does not cause any adverse reactions when in contact with a living tissue or organism such as a human subject, e.g., an eye of a human subject.

[0215] Non-limiting examples of biocompatible polymers include polyethylene, polypropylene, polyurethane, polyvinyl chloride, polytetrafluoroethylene, and polylactic acid.

[0216] As used herein the phrase “non-degradable” polymer” refers to a type of polymer that does not break down or degrade over time while in contact with a living tissue or organism. In some embodiments, some degree of degradation is allowed. In particular, in some embodiments, the grasper and / or portions thereof are designed and formed of material that degrades within a few weeks or months. Generally, however, such degradation is not desired as it may cause inflammation and / or cause weakening of the IOL anchoring. It is a particular feature of some embodiments of the invention that the implanted elements are wholly non-metallic.

[0217] Non-limiting examples of non-degradable and biocompatible polymer include, Poly(propylene), polyethylene, polytetrafluoroethylene (PTFE), polymethylmethacrylate (PMMA), polyether ether ketone (PEEK), and polyimide. According to some embodiments of the invention, element (305) comprises a metal alloy, which is optionally bent or elastically bends to a shape (such as a curved anchor) that cannot easily be retracted through the hole in the sclera. Optionally or additionally, element (305) has a hole defined there through for suturing.

[0218] Figure 6 describes some embodiments of the method of fixating an IOL as described in Figures 3-5.

[0219] At 602, the method comprises inserting the fixation tool into the eye. For example, the fixation tool can be inserted at a position posterior to the iris. It is noted that the fixation tool is optionally inserted into the eye while jaws (120) are in a closed configuration so that they fit into the trans-scleral hole. For grasping the IOL or the haptic grasper (325) is in an open configuration.

[0220] At 604, in order to open jaws (120) tube (350) is pulled towards proximal end of the IOL fixation tool.

[0221] Once jaws (120) are open, at 606, the method comprises fishing around for the haptic or for the IOL with jaws (120) by moving an actuator which controls over-tube (350) (e.g., as described in Figure 9A-D).

[0222] Then, at 608, the method comprises grasping the IOL or the haptic with jaws (120) and at 610, closing of jaws (120) which grasp the IOL or the haptic therebetween by advancing tube (350) towards the distal end of the IOL fixation tool over at least a portion of grasper (325) to force closure of jaws (120).

[0223] In order to maintain grasper (325) in a closed configuration after withdrawal of tube (350) the method comprises the step (612) of engaging ring (330) over grasper (325) to secure grasper (325) in a locked configuration with jaws (120) in close proximity to each other while grasping the IOL or the haptic.

[0224] In order to adjust the position and / or angle of the IOL and / or the haptic connected thereto at 614, the method comprises manipulating the position and / or angle of grasper (325), which is connected to the IOL and / or the haptic.

[0225] Once the position and / or angle of the IOL is correct, at 616, the method comprises anchoring strand (327) (also referred to as an “elongated body” or “filament” herein) in anchor (124) at the outer surface of sclera, optionally forming barrier (128).

[0226] As described above, anchoring strand (327) to the outer surface of the sclera can be effected by inducing diathermia, resulting in barrier (128) which prevents movement of the IOL fixation tool within the eye. In some embodiments, once strand (327) is anchored to the outer surface of the sclera, at 618, the method comprises detaching the remainder strand (157) which is proximal to anchor (124) from anchor (124) or from barrier (128).

[0227] In some embodiments the anchoring and the detachment occur concomitantly by inducing diathermia on elongated body (327) from the outer surface of the sclera.

[0228] Figure 7 depicts tool (700) which grasps an IOL. Tool (700) comprises jaws (720) with ring (730) on jaws (720), trans-scleral portion (705) of strand (727) attached to jaws (720) on the proximal end after removal of over-tube (750) from tool (700). Trans-scleral element (705) of the strand has barrier (728) designed to anchor tool (700) to the sclera (not shown here). laws (720) grasp haptic (757) of the IOL (756).

[0229] Figures 8A-C depict implantable portion of IOL fixation tool behind the iris of the eye.

[0230] Referring to Figure 8A. Shown are IOL (856) and haptic (857) of the IOL within the eye. Trocar (858) in inserted through the sclera behind the iris of the eye at penetration site (835).

[0231] According to some embodiments of the invention, penetration site (835) into the sclera of the eye is at the limbus.

[0232] According to some embodiments of the invention, penetration site (835) into the sclera of the eye is at a distance of 1.5 mm (millimeter) to 2 mm from the circumferential of limbus in the direction of the back of the eye.

[0233] According to some embodiments of the invention, penetration site (835) into the sclera of the eye is at the posterior chamber of the anterior segment. For example, penetration site (835) can be near or at the sulcus.

[0234] According to some embodiments of the invention, penetration site (835) into the sclera of the eye is at the cornea.

[0235] According to some embodiments of the invention, penetration site (835) into the sclera of the eye is at a distance of 3.5 mm to 4 mm from the circumferential of limbus in the direction of the back of the eye. For example, penetration site (835) can be near or at the Pars plana.

[0236] According to some embodiments of the invention, penetration site (835) into the sclera of the eye is at the vitreous cavity.

[0237] In some embodiments, selection of penetration site (835) is based on the desired location of anchor (824) (Shown in Figure 8C).

[0238] Additionally or alternatively, penetration site (835) into the sclera depends on the position of IOL (856) or haptic (857).

[0239] In some embodiments, when IOL (856) is devoid of haptic (857) and has a distorted angle of about 90 degrees with respect to the desired angle within the eye then penetration site (835) within the sclera is in a more posterior position within the eye, e.g., in a position towards the vitreous cavity. In some embodiments, there is more than one penetration site (835) within the sclera in order to manipulate IOL (856) into the right position and angle within the eye.

[0240] In some embodiments, fixation of the IOL to the sclera is performed near or at the sulcus (1.5-2 mm posterior to limbus).

[0241] Figure 8B shows implantation of IOL (856) within the eye using tool (800). Tool (800) is shown in both sides of IOL (856). Tool (800) is inserted through a trans-scleral hole which is usually generated using a Trocar (858) as shown in Figure 8A.

[0242] Figure 8C shows haptic (857) of IOL (856) (shown in Fig. 8B) after implantation within the eye. Jaws (820) of tool (800) grasp the haptic (857) and are in a locked configuration with ring (830) preventing jaws (820) from releasing haptic (857). Trans-scleral element (805) of the strand which is connected to jaws (820) is fixed to the sclera using anchor (824).

[0243] Figures 9A-D depict an IOL fixation tool (900) according to some embodiments of the invention.

[0244] Referring now to Figure 9A. IOL fixation tool (900) comprises an actuator (910). In one embodiments, actuator (910) is a squeeze to deploy actuator which can be used for manipulating over-tube (950) and for closing and opening jaws (920).

[0245] Actuator (910) comprises two arms (914) which when pressed towards each other push over-tube (950) in a distal direction and thus closes jaws (920). Actuator (910) further comprises coupler (912) and hinge (913). Jaws (920) are shown in an open configuration and ring (930) is proximal to jaws (920). Jaws (920) have step (911) on the outer surface thereof for locking ring (930) on jaws (920). Arms (914) of actuator (910) comprise axis forming hinge (913) which is connected to coupler (912). Hinge (913) is designed to allow squeezing of arms ( 14) towards each other and pushing over-tube (950) in a distal direction. Hinge (913) can be located at any place along arms (914) as long as it allows squeezing of arms (914) towards each other and pushing over-tube (950) in a distal direction. According to some embodiments, hinge (913) is located at a more distal part of arm (914). According to some embodiments, hinge (913) is located in the middle of arm (914).

[0246] Upon applying pressure on arms (914), which results in closing the distance between both arms (914) of actuator (910), coupler (912) pushes over-tube (950) in a distal direction while holding onto filament (927) which is shown in Figure 9D. Since over-tube (950) overlaps the proximal end of jaws (920) the pressure which is applied on arms (914) results in movement of jaws (920) towards each other while closing the distance there-between until they grasp an intraocular object such as IOL or haptic. For locking jaws (920), ring (930) is pushed in a distal direction by further squeezing arms (914) until ring (930) reaches step (911). Once ring (930) passes step (911) it cannot go back in the proximal direction and thus it leaves jaws (930) in a locked configuration.

[0247] Figure 9B is a cross section of tool (900) shown in Figure 9A. Shaft (955) (shown in Fig. 9A) holds strand (960) and can push ring (930) in a distal direction. Mechanism (916) includes locking pin (917, shown herein an exemplary location as part of mechanism (916)). Locking pin (917), which is also referred herein as “safety pin” prevents locking of jaws (920). In some embodiments, locking pin (917) can prevent movement of ring (930) in a distal direction.

[0248] In some embodiments, locking pin (917) can prevent squeezing of arms (914) “all the way” towards each other to a level which results in sliding ring (930) beyond step (911). Upon removal of locking pin (917) and squeezing of arms (914) towards each other over-tube (950) is pushed in a distal direction, and ring (930), which is at a distal end of over-tube (950), slides beyond step (911) and locks jaws (920).

[0249] In some embodiments, locking pin (917) can be placed in-between jaws (920) and prevents their locking by ring (930). Upon removal of locking pin (917) the jaws (920) approximate each other to a distance which is short enough to allow ring (930) to pass step (911) and lockjaws (920).

[0250] Figure 9C shows ring (930) over jaws (920), maintaining jaws (920) in a locked configuration.

[0251] Referring now to Figure 9D. After retracting over-tube (930) (shown in Figure 9A) towards the proximal direction, tool (951) comprises strand (927) in the proximal end and jaws (920) in the distal end. Jaws (920) remain in a locked configuration with ring (930) on them.

[0252] Referring now to Figures 10A-C. Tool (1000) is similar to tool (900) except that jaws (1020) comprise segment (1021) configured to reduce over-pressure or pinching forces on intraocular objects captured therebetween. Tool (1000) comprises actuator (1010) with arms (1014), over-tube (1050), coupler (1012), hinge (1013) and jaws (1020). When jaws (1020) approximate towards each other the space between them remains equal along the entire length of segment (1021). Jaws (1020) further comprise step (1011) for holding ring (1030).

[0253] Figure 10B shows jaws (1020) approaching towards each other when compared to their relative position from each other as in Figure 10A.

[0254] Figure 10C shows a cross section of tool (1000) showing strand (1027) [as strand (327) in Figures 3-5], ring (1030) [as ring (330) in Figures 3-5], step (1011) [as step (311) in Figures 3-5] of jaws (1020) [as jaws (320) in Figures 3-5], and segment (1021).

[0255] Figures 10D-E show tool (1000) with locking pin (1017). Figure 10D shows locking pin (1017) inserted into shaft (1055). Figure 10E shows locking pin (1017) when removed from shaft (1055). When locking pin (1017) is pushed inside shaft (1055) it prevents the shaft (1055) to move in a distal direction.

[0256] Figure 10F shows jaws (1020) in a closed configuration with ring (1030) being in a proximal end of step (1011) of jaws (1020). Step (1011) is not visible since ring (1030) covers it.

[0257] Figure 10G shows jaws (1020) in a locked configuration with ring (1030) over jaws (1020).

[0258] Figure 10H shows an implantable tool (1051) which comprises jaws (1020) in a locked configuration with strand (1027), after retracting of over-tube (1050). It is noted that an optional feature shown in this Figure is that the part of jaws (1020) over which ring (1030) lies are not in contact with each other. This may add elasticity to the locking and / or avoid locking problems due to debris. Optionally or additionally, it may help avoid pinching damage to the IOL (e.g., as the jaw portions contacting the IOL can be flat and parallel to each other).

[0259] Figures 11A-E depict the manufacture of an implantable tool (1100) according to some embodiments. In Figure 11 A jaws (1120) are in an open configuration and being connected at their proximal end to hole (1131). In Figure 11B strand (1127) is inserted through hole (1131) in a direction from a distal end of tool (1100) to a proximal end of tool (1100). It is noted that the arrow head points at the direction of insertion. In Figure 11C strand (1127) passes through hole (1131) towards the proximal end of tool (1100). In Figure HD, barrier (1138) is formed by applying diathermia at the distal end of strand (1127). Barrier (1138) has a dome-like shape having a diameter which is larger than the diameter of hole (1131), thus preventing the further passing of the distal end of strand (1127) through hole (1131) in the proximal direction. In Figure 1 IE barrier (1138) remains in the distal end of hole (1131).

[0260] In some embodiments the physician / surgeon can assemble tool (1100) in the operating room in order to select a specific strand (suture) to be used.

[0261] Figures 12A-F depict an implantable part (1200) for grasping an IOO such as an IOL. Tool (1200) comprises jaws (1220) which are designed for grasping the IOO. Jaws (1220) are connected to each other at the proximal end thereof while forming hole (1231), which is designed for inserting strand (1227) there through (e.g., as schematically described in Figures 11A-E). Jaws (1220) also form loop (1232) for inserting safety pin (1217) there through.

[0262] Jaws (1220) have a shape which is suitable for positioning ring (1230) in three different locations along jaws (1220). Location (1218) is at the further proximal end of jaws (1220) and can hold ring (1230) on the top of loop (1232). Safety pin (1217) is designed to fit into loop (1232). When ring (1230) (not shown here) is at location (1218) jaws (1220) are maintained in a closed configuration. For example, jaws (1220) are in a closed configuration when tool (1200) is inserted into the eye through the sclera. Location (1215) is more distally with respect to location (1218) and forms a socket in jaws (1220). While safety pin (1217) is within loop (1232) pressure applied on or released from the arms of the actuator (as described in Figures 10A-H) results in the movement of ring (1230) between areas (1218), (1215) and (1219) along jaws (1220).

[0263] When ring (1230) is moved more distally into the socket at location (1215), the jaws (1220) are maintained in an open configuration. For example, jaws (1220) are in an open configuration when tool (1200) is used for grasping the IOO.

[0264] When ring (1230) is moved more distally to location (1219) the jaws (1220) can be closed. For example, jaws are in a closed configuration when grasping an IOO.

[0265] In order to lock jaws (1220) safety pin (1217) is removed and then the shaft (shown in Figures 10D-E) allows ring (1230) to pass forward (in a distal direction) beyond step (1211). Optionally, once ring (1230) is beyond step (1211), jaws (1220) are locked and the shaft is withdrawn from the eye and strand (1227) is exposed.

[0266] In some embodiments, safety pin (1217) is removed manually by the hand of the eye surgeon.

[0267] According to some embodiments of the invention, strand (1227) comprises polypropylene (e.g., PROLEN).

[0268] Figures 12A and 12B show tool (1200) in two different views, in which jaws (1220) are in an open configuration.

[0269] Figure 12C tool (1201) represents half of tool (1200). Shown is a vertical view of tool (1201) with magnification of teeth (1234) on jaw (1220). Also shown is half of hole (1231) and loop (1232).

[0270] Figure 12D shows tool (1200) before insertion into the eye through the trans-scleral hole. Ring (1230) is at location (1218) and jaws (1220) are in a closed configuration. According to some embodiments of the invention, the distance between the two inner surfaces of jaws (1220) when the jaws are in the closed configuration (marked by a dashed double arrow and the letter “A”) is for example between 0.01 and 1.8 mm, between 0.2 and 1.3 mm, between 0.2-0.3 mm, e.g., about 0.2 mm, e.g., about 0.3 mm.

[0271] According to some embodiments of the invention, the distance between the two outer surfaces of jaws (1220) when the jaws are in the closed configuration (marked by a dashed double arrow and the letter “B”) is between for example between 0.25 and 2.0 mm, between 0.25 and 1.0 mm, between 0.48-1.0 mm, e.g., about 0.48 mm.

[0272] Figure 12E shows tool (1200) after insertion of tool (1200) into the eye, in which ring (1230) is at location (1215) and jaws (1220) are in an open configuration. The distance between the two inner surfaces of jaws (1220) when the jaws are in the opened configuration (marked by a dashed double arrow and the letter “C”) is for example between 0.3 and 4 mm, between 0.5 and 2 mm, between 0.8-1.5 mm, and / or between 0.9 and 1.2 mm, e.g., about 0.9 mm, e.g., about 0.98 mm, e.g., about 1.5 mm.

[0273] According to some embodiments of the invention, the distance between the two outer surfaces of jaws (1220) when the jaws are in the open configuration (marked by a dashed double arrow and the letter “D”) is between for example between 0.55 and 4.50 mm, between 0.75 and

[0274] 2.25 mm, between 1.1-1.35 mm.

[0275] Figure 12F shows tool (1200) after locking jaws (1220) with ring (1230). Ring (1230) is at location (1211) and jaws (1220) are in a locked configuration. The distance between the two inner surfaces of jaws (1220) when the jaws are in the locked configuration (marked by a dashed double arrow and the letter “E”) is for example, between 0.0- 1.0 mm, between 0.1-1 mm, e.g., between 0.38-1.00, e.g., about 0.38 mm, e.g., about 1 mm.

[0276] According to some embodiments of the invention, the distance between the two outer surfaces of jaws (1220) when the jaws are in the locked configuration (marked by a dashed double arrow and the letter “F”) is between for example between 0.25 and 1.25 mm, between 0.35 and

[0277] 1.25 mm, between 0.63-1.25 mm.

[0278] Figure 12G shows tool (1200) according to some embodiments of the invention, of which the total length of jaws (1220) is about 4 mm (e.g., 4 mm).

[0279] In some embodiments, the length of the distal part of jaws (1220) from step (1211) until the distal end is about 1.5 mm. In some embodiments the length of the distal part of jaws (1220) from step (1211) until the distal end is smaller than 1.5 mm. In some embodiments the length of the distal part of jaws (1220) from step (1211) until the distal end is up to 50% smaller than 1.5 mm.

[0280] In some embodiments, the length of the proximal part of jaws (1220) corresponding to area (1218) is about 0.5 mm. In some embodiments, the length of the proximal part of jaws (1220) corresponding to area (1218) is smaller than 0.5 mm. In some embodiments, the length of the proximal part of jaws (1220) corresponding to area (1218) is up to 50% smaller than 0.5 mm.

[0281] In some embodiments the total length of the grasper is smaller than 4 mm. In some embodiments the total length of jaws (1220) is up to 50% smaller than 4 mm. In some embodiments the total length of the grasper is up to 2.5 mm. In some embodiments the total length of the grasper is about 2.5 mm.

[0282] Referring now to Figures 13A-G showing fixation and / or manipulation tool (1300) in open, closed or locked configurations. Figures 13A-B show tool (1300) in a closed configuration prior to release of safety pin (1317) by the eye surgeon. Figure 13A shows tool (1300) with grasper (1325) having jaws (1320) in a closed configuration. Safety pin (1317) is secured within the shaft of tool (1300). Figure 13B shows ring (1330) over part of jaws (1320) while in the closed configuration.

[0283] Figures 13C-D show tool (1300) in a locked configuration after the release of safety pin (1317) by the eye surgeon. It is noted that in Figure 13D, which is after the release of safety pin (1317), ring (1330) is advanced more distally as compared to its location in Figure 13B when the tool (1300) is in the closed configuration (prior to release of safety pin (1317)).

[0284] Figures 13E-G show tool (1300) after release of safety pin (1317) from the tool.

[0285] Figure 13E shows tool (1300) in a locked configuration and after the release of strand (1327) from the proximal part of tool (1300).

[0286] Figure 13F is a cross section of tool (1300) while in the locked configuration with arrow (1331) pointing at the minimal separation (e.g., gap) between the upper and lower arms of the tool. In some embodiments, the gap comprises a safety pin (1317) that prevents the arms of the tool from closing completely. When the safety pin is removed, the two wings (e.g., arms) of the tool can be closed and then the locking ring is pushed forward (in a distal direction).

[0287] After the release of the safety pin (1317), the two coupler parts (1312) can be pushed towards each other, to cause over-tube (1350) to be pushed in the distal direction.

[0288] Figure 13G is an overview of tool (1300) while in the locking configuration, showing withdrawal of part of over- tube (1350) in the proximal direction.

[0289] Figures 14A-C show tool (1400) according to some embodiments of the invention. Tool (1400) comprises a locking mechanism (1470) which allows to secure the IOO in between the jaws (1420) in a locking configuration.

[0290] Locking mechanism (1470) may comprise 2 locking members (1471) and (1472) which together secure locking of jaws (1420) with the IOO there-between. Locking member (1471) can include a tab or a protrusion which is inserted into a slot or a recess in locking member (1472). By pressing locking members (1471) and (1472) towards each other (e.g., by pressing the arms (1014) of the actuator as shown e.g., in Figure 10A), the tab or protrusion of locking member (1471) slides past a threshold or a ridge in locking member (1472) and then sits in a recess of locking member (1472). It is noted that once the tab or the protrusion of locking member (1471) sits within the recess of locking member (1472) elastic forces securely hold the connection between the two locking members. Locking members (1471) and (1472) can be made of plastic.

[0291] For grasping the IOO, arms (914) of actuator (910) (shown in Figures 9A-D) are squeezed by the eye surgeon, resulting in the two jaws approaching towards each other. As long as safety pin (1317) is safely secured in place (e.g., within the shaft of tool (1400)) squeezing of the arms (914) cannot result in locking of the jaws by locking mechanism (1470). Once safety pin (1317) is removed by the eye surgeon, squeezing of arms (914) can allow locking of the jaws by locking mechanism (1470), by inserting the protrusion of locking member (1471) into the recess of locking member (1472).

[0292] Figure 14A shows tool (1400) in an open configuration with the two members (1471) and (1472) of locking mechanism (1470) are spaced apart from each other.

[0293] Figure 14B shows tool (1400) in a closed configuration in which the two locking members (1471) and (1472) may be in contact (e.g., touch) with each other but not in a snap-locked position.

[0294] Figure 14C shows tool (1400) in a locked configuration in which protrusion in the up-right arm of locking member (1471) is inserted into the recess of locking member (1472) in a snap- locked position which prevents opening of locking mechanism (1470).

[0295] Referring now to Figure 15. Figure 15 describes a method of manipulating and / or fixating an IOO within the eye. References 1502-1510 correspond to references 602-610, respectively, which are describe in reference to Figure 6.

[0296] At 1511, once the IOO is properly grasped between the jaws, removing safety pin (1317) by the eye surgeon to allow locking of the jaws.

[0297] At 1512, the locked configuration can be secured by either engaging ring (33) over grasper (325) (e.g., as exemplary shown in Figures 10A-H), or by locking using the locking mechanism (1470).

[0298] At 1514, when the IOO is an IOL, the position of the grasper is manipulated in order to adjust the position and / or angle of the IOL; and at 1516 the strand (327) is anchored to the outer surface of the sclera, preferably by forming a barrier. At 1518, once the strand is anchored, the remainder strand is detached.

[0299] In some embodiments, when the manipulation tool is not used for fixation of an IOO but rather for manipulating an IOO within the eye, e.g., a foreign body, or a non-functional (e.g., destroyed, or damaged) IOL, once the IOO is grasped and locked between the jaws of the grasper, the method can further include a step of withdrawing the manipulation tool outside of the eye, and thus, removing the IOO from the eye.

[0300] As used herein the term “about” refers to ± 10 %.

[0301] The terms "comprises", "comprising", "includes", "including", “having” and their conjugates mean "including but not limited to".

[0302] The term “consisting of’ means “including and limited to”. The term "consisting essentially of" means that the composition, method or structure may include additional ingredients, steps and / or parts, but only if the additional ingredients, steps and / or parts do not materially alter the basic and novel characteristics of the claimed composition, method or structure.

[0303] As used herein, the singular form "a", "an" and "the" include plural references unless the context clearly dictates otherwise. For example, the term "a compound" or "at least one compound" may include a plurality of compounds, including mixtures thereof.

[0304] Throughout this application, various embodiments of this invention may be presented in a range format. It should be understood that the description in range format is merely for convenience and brevity and should not be construed as an inflexible limitation on the scope of the invention. Accordingly, the description of a range should be considered to have specifically disclosed all the possible subranges as well as individual numerical values within that range. For example, description of a range such as from 1 to 6 should be considered to have specifically disclosed subranges such as from 1 to 3, from 1 to 4, from 1 to 5, from 2 to 4, from 2 to 6, from 3 to 6 etc., as well as individual numbers within that range, for example, 1, 2, 3, 4, 5, and 6. This applies regardless of the breadth of the range.

[0305] Whenever a numerical range is indicated herein, it is meant to include any cited numeral (fractional or integral) within the indicated range. The phrases “ranging / ranges between” a first indicate number and a second indicate number and “ranging / ranges from” a first indicate number “to” a second indicate number are used herein interchangeably and are meant to include the first and second indicated numbers and all the fractional and integral numerals therebetween.

[0306] As used herein, the term “treating” includes abrogating, substantially inhibiting, slowing or reversing the progression of a condition, substantially ameliorating clinical or aesthetical symptoms of a condition or substantially preventing the appearance of clinical or aesthetical symptoms of a condition.

[0307] It is appreciated that certain features of the invention, which are, for clarity, described in the context of separate embodiments, may also be provided in combination in a single embodiment. Conversely, various features of the invention, which are, for brevity, described in the context of a single embodiment, may also be provided separately or in any suitable subcombination or as suitable in any other described embodiment of the invention. Certain features described in the context of various embodiments are not to be considered essential features of those embodiments, unless the embodiment is inoperative without those elements.

[0308] In addition, any priority document(s) of this application is / are hereby incorporated herein by reference in its / their entirety.

Claims

WHAT IS CLAIMED IS:

1. A method of fixation of an intraocular lens (IOL) comprising:(a) inserting a fixation tool posterior to the iris;(b) grasping the IOL between two flat facing surfaces of a grasper of said fixation tool; and(c) anchoring a proximal end of said grasper to a sclera.

2. The method of claim 1, wherein said anchoring of said proximal end of said grasper is to an outer surface of said sclera.

3. The method of claim 1 or 2, further comprising adjusting a position of the IOL with said grasper prior to anchoring.

4. The method of any one of claims 1-3, further comprising adjusting an angle between said grasper and the IOL.

5. The method of any one of claims 1-4, further comprising choosing and setting an angle between said grasper and said inner surface of said sclera prior to said anchoring.

6. The method of any one of claims 1-5, wherein said grasping is effected by approximating said two grasping surfaces towards each other.

7. The method of any one of claims 1-6, wherein prior to said grasping the method comprises changing the configuration of said grasper to an open configuration.

8. The method of any one of claims 1-7, wherein prior to said grasping the method further comprising:(a) moving said grasping surfaces until the IOL is between said surfaces, and(b) activating said grasping surfaces to grasp the IOL.

9. The method of any one of claims 1-8, wherein said grasping is of an haptic of theIOL.

10. The method of any one of claims 1-8, wherein said grasping is of a lens of the IOL.

11. The method of any one of claims 1-10, wherein said grasping is effected by changing the configuration of said grasper to a closed configuration.

12. The method of any one of claims 1-11, further comprising generating a trans-scleral hole having a diameter sufficient for inserting said fixation tool.

13. The method of any one of claims 1-12, further comprising detaching said proximal end of said grasper from an elongated body of said fixation tool.

14. The method of claim 13, wherein said detaching is effected by diathermia.

15. The method of claim 1, wherein said anchoring is to an outer surface of said sclera and is performed by diathermia or a trans-sclera thread.

16. A method of fixation of an intraocular lens (IOL) comprising:(a) inserting a fixation tool posterior to the iris;(b) grasping the IOL and / or an haptic of the IOL between two facing surfaces of a grasper of said fixation tool;(c) anchoring a proximal end of said grasper to a sclera and / or to an outer surface of said sclera, and;(d) adjusting an angle between said grasper and the IOL, between said grasper and said haptic, and / or between said grasper and said inner surface of said sclera.

17. The method of any one of claims 1-16, further comprising identifying an IOL dislocation in a subject prior to said inserting in step (a).

18. The method of any one of claims 1-17, wherein said inserting is through said sclera in a close proximity to the limbus.

19. The method of any one of claims 1-18, further comprising selecting a position for said inserting based on position of said haptic.

20. The method of any one of claims 1-19, wherein said inserting said fixation tool is performed into a posterior chamber of the anterior segment.

21. The method of any one of claims 1-19, wherein said inserting said fixation tool is performed into the vitreous cavity.

22. The method of any one of claims 1-21, wherein said anchoring is performed near or at the sulcus.

23. An intraocular lens (IOL) fixation tool, comprising:(a) an elongated body comprising a trans-scleral element;(b) a grasper at a distal end of said body comprising:(i) at least two axially extending arms which define flat facing grasping surfaces,(ii) means for approximating said arms towards each other so that they grasp.

24. The IOL fixation tool of claim 23, wherein said grasper has a closed configuration and an open configuration, and wherein a maximal proximity between said two grasping surfaces in said closed configuration is suitable for anchoring said haptic and / or said IOL between said grasping surfaces while minimizing pinching forces.

25. The IOL fixation tool of any of claims 23-24, wherein said means for approximating said arms towards each other comprise:(i) a tube which surrounds at least a portion of the grasper,(ii) a ring which engages said grasper in a locked configuration, and(iii) at least one switch for controlling movement of said tube along said elongated body.

26. The IOL fixation tool of any one of claims 23-24, wherein a combined length of said trans-scleral element and said grasper does not exceed 4.0.

27. The IOL of claim 26, wherein a maximal diameter of the IOL fixation tool which comprises said grasper in said closed configuration does not exceed 0.6 mm.

28. The IOL fixation tool of any one of claims 23-27, wherein said grasper comprises nitinol or titanium.

29. The IOL fixation tool of any one of claims 23-28, wherein said trans-scleral element comprises a non-degradable biocompatible polymer.

30. An implantable tissue grasper device comprising:(i) an implantable grasper, and(ii) a bendable elongated body, said bendable elongated body has a proximal end and a distal end, wherein said distal end is connected to said implantable grasper, and wherein said proximal end comprises a barrier having a diameter which exceeds a maximal diameter of said grasper when said grasper is closed.

31. The implantable tissue grasper of claim 30, wherein said bendable elongated body and said barrier comprise a non-degradable biocompatible polymer.

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