A clamping device for an IOL and an interchangeable IOL insert

Abstract

The present invention provides a clamping device that is able to accurately handle an IOL during pre-surgery preparation. The clamping device is ergonomically designed so that it can be operated with ease and allows for a predetermined force to be applied to the IOL. The clamping device comprises an interchangeable insert (700) which is configured for marking and / or piercing suture points directly on the IOL. Furthermore, the clamping device comprises an interchangeable IOL receiving insert (300, 300a) dimensioned to receive the haptics of a predetermined IOL so as to cause the haptics of any specific intraocular lens (IOL) being aligned at specified orientation in such a way to allow the IOL to be marked, pierced or sutured, prior to inserted in an eye.

Description

A CLAMPING DEVICE FOR AN IOL AND AN INTERCHANGEABLE IOL INSERTTECHNICAL FIELD

[0001] The present disclosure relates to systems, apparatus and methods for extraocular handling of intraocular lenses. Particularly, the present disclosure relates to system apparatus and methods for IOL handheld clamping device, including features for orient, fixing, marking, piercing and suturing of an intraocular lens, for improved sclera support, in absence of capsular one, at cataract surgery operations.BACKGROUND

[0002] The insertion of an intraocular lens in the absence of capsular support is a special case of cataract surgery with special technical requirements for its performance. Existing options include insertion of the intraocular lens in the anterior chamber, suturing the intraocular lens to the iris, suturing the intraocular lens to the sclera or finally supporting the intraocular lens in the sclera without suturing as described by Tsatsos, M., Vartsakis, G., Athanasiadis, I. et al. “Intraocular lens implantation in the absence of capsular support: scleral fixation” Eye 36, 1721-1723 (2022). https: / / doi.org / 10.1038 / s41433-022-02024-3. The last option has several advantages including the closeness of the position of the inserted intraocular lens with the one where the intraocular lens is normally located and its technical simplicity.

[0003] The approach of supporting the intraocular lens in the sclera without suturing is currently carried out in two main ways a) the use of a special type of intraocular lens with support anchors through which it is attached to the sclera, as described by Ripa M, Angunawela R, Motta L. “SCLERAL FIXATION OF CARLEVALE INTRAOCULAR LENS: A Systematic Review and Meta- Analysis” Retina. 2023 Oct 1 ;43(10): 1750-1762.),and b) the use of common intraocular lenses that are attached to the sclera either with the help of their haptics or with the use of a suture without stitching as described by Veronese C, Maiolo C, Armstrong GW, Primavera L, Torrazza C, Della Mora L, et al. “New surgical approach for sutureless scleral fixation” Eur J Ophthalmol. 2020;30:612-5. The latter approach offers the great advantage of allowing the insertion of any intraocular lens the surgeon has or wishes. In particular, techniques using sutures for the attachment of intraocular lenses practically allow the surgical attachment of a huge selection of intraocular lenses as described by Yamane S, Sato S, Maruyama-Inoue M, Kadonosono K. “Flanged intrascleral intraocular lens fixation with double-needle technique” Ophthalmology. 2017; 124: 1136-42.

[0004] The suture-based intraocular lens suspension procedure involves the insertion of the support sutures in two or more points in the intraocular lens. Most intraocular lenses are mounted with two sutures. This procedure requires precise antidiametric positioning of the sutures to ensure axial symmetry and to avoid tilting of the intraocular lens along the horizontal axis when inserted as described by Kumar DA, Agarwal A, Prakash G, Jacob S, Saravanan Y, Agarwal A. “Evaluation of intraocular lens tilt with anterior segment optical coherence tomography” Am J Ophthalmol. 2011; 151 :406-12.e2.

[0005] US2342146 describes a device that applies consistent gripping force to lenses of varying sizes and shapes, ensuring stability during processes like edging or grinding. WO20 17217443 Al details a toric intraocular lens with specifi c alignment markings and a corresponding insertion tool, designed to improve the accuracy of lens placement during cataract surgery. However, the performance of known devices for handling the IOL so as to insert the support sutures and marking of the IOL is not standardized and involves handling difficulties as well as failures in the precise selection of suture insertion points on the IOL.

[0006] Therefore there is a need to provide a standardize procedure for handling the IOL prior to implantation and facilitate the accurate marking and selection of the suture passage points.SUMMARY

[0007] The present invention relates to a clamping device for facilitating handling an IOL prior to implantation that overcome the disadvantages of prior art solutions. More specifically, the present invention provides a clamping device that is able to accurately handle an IOL during pre-surgery preparation. The clamping device is ergonomically designed so that it can be operated with ease and allows for a predetermined force to be applied to the IOL. Furthermore, the clamping device comprises an interchangeable insert which is configured for marking and / or piercing suture points directly on the IOL. As a result, the present invention provides a clamping device that can accurately handle the IOL, and further facilitate via the interchangeable insert the accurate marking, piercing or suturing of the IOL. The invention is further defined in the appended claims.BRIEF DESCRIPTION OF THE DRAWINGS

[0008] The following drawings are provided as an example to explain further and describe various aspects of the invention.FIG. l is a perspective view of an example extraocular IOL handheld operated clamping device.FIG. 2 shows a longitudinal cross-sectional view of the extraocular IOL handheld operated clamping device.FIG. 3 is a perspective view of a distal portion of an example clamping body of the extraocular IOL handheld operated clamping device of FIG.1FIG. 4 is a perspective view of a distal portion of an example clamping device, clamping member of the extraocular IOL handheld operated clamping device of FIG.1FIG. 5 is a perspective view of a distal portion of an example clamping device fixing element of the clamping member of the extraocular IOL handheld operated clamping device of FIG.1FIG. 6 is a perspective view of a distal portion of an example clamping device interchangable, IOL receiving insert, of the extraocular IOL handheld operated clamping device of FIG.1FIG. 7 is a perspective view of an example extraocular IOL handheld operated clamping device in open position.FIG. 8 is a perspective view of an example extraocular IOL handheld operated clamping device in fixed position.FIG. 9 shows an example of an IOL.FIG. 10 shows an example of a toric IOL.FIG. 11 shows a side view of an example clamping member of the extraocular IOL handheld operated clamping device of FIG.1FIG.12 shows a perspective view of the piercing insert, locked in position on the clamping member of the extraocular IOL handheld operated clamping device of FIG.1Fig. 13 shows a perspective focused view of the clamping region of an exemplified clamping member of an extraocular IOL handheld operated clamping device.FIG. 14 shows a perspective focused view of the front portion of an example extraocular IOL handheld operated clamping device of FIG. 1.FIG.15 shows a perspective view of an example of an IOL piercing insert of the extraocular IOL handheld operated clamping device of FIG.1FIG. 16 shows a top side view of an example of an interchangeable IOL receiving insert according to embodiments of the present inventionsFIG. 16a shows a perspective view of an example of an interchangeable IOL receiving insert comprising notches for accommodating a cover according to embodiments of the present invention.FIG.16b shows a perspective view of an example of an IOL interchangeable receiving insert cover.FIG.16c shows a perspective view of an example of a combination of an interchangeable IOL receiving insert and a cover placed in position.FIG.16d shows a perspective view of an alternative design of an interchangeable IOL receiving insert according to embodiments of the present invention.FIG. 17 shows an example suturing needle.FIG. 18 shows a top field of view from the operator’s sight, of the clamping member over the interchangeable IOL receiving insert.FIG. 19 shows a top side view of an example clamping device, interchangeable IOL receiving insert, with an IOL in position.FIG. 20 shows a top field of view from the operator’s sight, of the clamping member over the interchangeable IOL receiving insert, with an IOL in position and a suturing needle in position performing a suture action.FIG.21 shows a cross sectional view of the pivot housing of an example clamping body of the extraocular IOL handheld operated clamping device of FIG.1DETAILED DESCRIPTION

[0009] For the purposes of promoting an understanding of the principles of the present disclosure, reference will now be made to the implementations illustrated in the drawings, and specific language will be used to describe the same.

[0010] It will nevertheless be understood that no limitation of the scope of the disclosure is intended. Any alterations and further modifications to the described devices, methods and any further application of the principles of the present disclosure are fully contemplated as would normally occur to one skilled in the art to which the disclosure relates. In particular, it is fully contemplated that the features, components, and / or steps described with respect to one implementation may be combined with the features, components and / or steps described with respect to other implementations of the present disclosure.

[0011] The present disclosure relates to systems, apparatuses and methods for clamping and suturing an IOL, prior to implantation into an eye of a patient.

[0012] Particularly, the present disclosure relates to systems, apparatuses and methods for IOL extraocular handheld clampers, having features for precise and accurate marking and / or piercing, and / or suturing of an IOL, prior to insertion.

[0013] In general, the present disclosure relates to an extraocular handheld operated clamping device of an intraocular lens, (IOL), that may include an interchangeable IOL receiving insert 300, a clamping body 100 having an IOL receiving region 150 for receiving the interchangeable IOL insert 300, a clamping member 200, and fixing element 400. The clamping device may include a longitudinal axis extending centrally along the clamping body, that may include a front portion 160, a rear portion 110 and a bridge portion 130 that connect the two previous portions. A front portion of clamping member 200 may include a pivot housing 250, which is formed between two opposing sidewalls that permit a limited rotational movement of the clamping member 200 about a pivot axis 420 in open and closed positions, when mounted on a front portion 160 of the clamping device 100. The pivot housing 250 may include a fixing element 400 that forms the pivot axis 420 and apply a predictable force to the sidewalls of the pivot housing 250 in order to fix in place the clamping member 200 on the clamping body 100. The clamping member 200 may include a lever arm formed at the rear portion 210 of the clamping member 200 and a clamping region 210 comprising a pressing region 230 configured to press firmly the IOL positioned in the IOL receiving interchangeable insert 300 without damage. The clamping region provides a top viewed contour that permit unobstructive view of the IOL in the IOL receiving interchangeable insert 300 . The bridge portion 130 of the clamping body 100 may include an interchangeable insert housing compartment, adapted to receive different types of interchangeable IOL receiving inserts 300 in order to house different types of intraocular lenses (“IOL”), for loading on the clamping device. The interchangeable IOL receiving insert 300 may include specific regions on the top surface, as to housing at predetermined orientation and position an appropriate type of intraocular lens each time, with features that ensure the precise marking and / or piercing and / or suturing of the IOL, and also specific regions on the bottom surface in order to be locked in place on corresponding regions of the interchangeable insert housing compartment of the bridge portion 130 of the clamping device. The rear portion 110 of the clamping body may include a hand grip surface and anatomically contoured handle part, that serves the precise control and handling of the clamping device by the operator. The interchangeable IOL receiving insert 300 may include a rotational IOL receiving region, in order to allow toric IOL’S tooriented radially for precise marking and / or piercing, and / or suturing. The rear portion 110 of the clamping body 100, may include a thumb operated rotation mechanism, for the precise rotation of the toric IOL receiving region of the interchangeable IOL receiving insert 300 prior to be marked, pierced or sutured.

[0014] In exemplary embodiments, the fixing element 400 may include an applied force adjusting knob 410, with friction aided surface, for precise control by the user and marking indicators on it for predictable force load setting. The fixing element 400 may further include an eccentric cam lever clamping mechanism, or a slider clamping mechanism, in place of previous screwing bolt system, that permits simpler and more secure application.

[0015] In exemplary embodiments, the pivot housing 250 may include a rotational angle limiter region 260 configured to limit the rotational movement a of the clamping member200 about the pivot point, when it comes into contact with the corresponding shaped bottom part of the clamping member 200.

[0016] In exemplary embodiments, the clamping member 200 may have a shorter length as to reduce the applied torque on the pivot axis 420 and the clamping region 230, of it by the operator’s hand action.

[0017] In further exemplary embodiments, the clamping member 200 of the clamping device may include a clamping region 220, that can receive interchangeable inserts 700 for precise marking or piercing of the IOL. These interchangeable inserts 700 act as aid devices at the performed operations on the IOL, or as independent operating devices. The interchangeable insert 700, may include additional features of combined marking, piercing, or suturing action, using special configured needles.

[0018] It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory in nature and are intended to provide an understanding of the present disclosure without limiting the scope of the present disclosure. In that regard, additional aspects futures and advantages of the present disclosure will be apparent to one skilled in the art from the following detailed description.

[0019] FIG. 1 shows an example extraocular IOL handheld operated clamping device, that includes a clamping body 100, a rotational and adjustable IOL clamping member 200, afixing element 400, a IOL receiving region 150 operable to house an interchangeable IOL receiving insert300..

[0020] FIG. 2 shows a longitudinal cross-sectional view an example extraocular IOL handheld operated clamping device according to embodiments of the present invention. The clamping device comprises a clamping member 200, interchangeable IOL receiving Insert 300 and pivot hole 240. The clamping member 200 comprises a clamping region 220 having an IOL pressing region 230. The clamping region 220 has a thinned silhouette contour, so as to provide a clear field of view of the IOL optical disk to the operator, when the clamping member 200 is in the closed position. The clamping member 200 is configured to be secured, when in the closed positioned, at a pocket region defined between the front portion 160 and the front-end 120 of the rear portion 110.

[0021] FIG.3 shows a side view of the extraocular IOL handheld operated clamping body 100 according to embodiments of the present invention. An anatomically shaped handheld rear portion 110, which in some instances has a light weighting structure with openings distributed in a predetermined pattern on the handle portion in other instances may have a flat bottom shape that permits leveled positioning of the device on a bench, in other instances may have any desired contour. The front end 120 of the rear portion 110 of the clamping body 100, may form a pocket that can be used in a number of different ways depending on the design of the clamping device. For example, the rear portion 110 may receive the clamping member 200, when in the closed position, at a location formed between a front end 120 of the rear portion 110 and the front porti on 160 of the clamping body 100. In a further example, the rear portion 110 may form a friction gripping surface, for use with a short lever clamping member 200 designed to reach the rear end of the interchangeable IOL receiving insert 300. In yet further examples, rear portion 110 at the location of the front-end region 120 may house a mechanism that controls the rotation of the interchangeable IOL receiving insert 300 of a specific interchangeable, toric IOL receiving insert. The clamping body 100 comprises a bridge portion 130, that connects the rear porti on 110 of the clamping body 100, to the front portion 160, Also, the upper portion of the bridge portion 130, forms an IOL receiving region 150 comprising radius shape formed walls 140, that hold and secure in position the interchangeable receiving insert 700for marking, piercing, or suturing the IOL. The front portion 160 of the clamping body 100 is configured to receive a pivot housing 250 of the clamping member 200. The pivot housing 250 has two side walls and is configured to be mounted on the front portion 160 of the clamping body 100 via a corresponding pivot hole 240 on the clamping body 100 and clamping member 200trough which passes the fixing element 400 which forms the pivot axis 420.

[0022] FIG.4 shows a perspective view of the clamping member 200according to embodiments of the present invention. The clamping member 200 comprises the pivot housing 250 a pivot axis hole 240, a flat bottom area that acts as a stopper when the clamping member is in the open position, a friction gripping area, for better operator’s finger positioning, the clamping region 220 IOL comprising a pressing region 230, the clamping region provided with a slimline contour profile

[0023] FIG.5 shows a perspective view of a fixing element 400 of the clamping device according to embodiments of the present invention. The fixing element 400 may be provided with a knurled or other friction aided knob 410 for secure handling of the fixing element , which knob 410 is connected with a coaxial cylindrical part which act as a bearing for load transfer to the clamping body, and forms a pivot axis 420 that permits the clamping member 200, to rotate freely on it, the fixing element 400 has a threaded portion 430 which in series screwed in the clamping body via a threaded part of the pivot axis hole 240, so it can adjust the fixing force that keeps in place the clamping member 200. The knob 410 may have force indicator markings on it, to adjust the required force at predefined levels.

[0024] FIG.6 shows a perspective view of interchangeable IOL receiving insert 300 for use with the clamping device according to embodiments of the present invention. The interchangeable IOL receiving insert 300 comprises a top area defining a haptics accommodation region 350 dimensioned for accommodating the haptics of a predetermined type IOL and a bottom region 320. The bottom region 320 defining a bottom channel 310 having a profile that is dimensioned to clip and secure the interchangeable IOL insert 300 to the IOL receiving region 150 of the clamping body 100. More specifically, the profiled bottom channel 310, matches the profile of the IOL receivingregion 150 of the clamping body 100, as to clip end secure in place the interchangeable IOL receiving insert 300. The specific profile shaped bottom region 320 further helps the operator to hold and easily manipulate the interchangeable IOL receiving insert 300. The top area of the interchangeable IOL receiving insert 300 comprises two radially and anti diametrically positioned guide slots 330, for guiding the needles for suturing the IOL, e.g. via a IOL receiving insert 700, thus ensuring the accurate radius distance of the holes made in the IOL , as also the angle, in respect of IOL orientation. The top area of the IOL receiving insert body further comprises a pair of protruding arch shaped guiding features 340 in antidiametrically positions in respect of the rotational axis of the IOL, where they form a region that secure the optical diameter of the IOL disk and due to their position receive and lock the IOL haptics at specific anytime angle. The haptics accommodation region 350 is dimensions to receive the IOL haptics of a predetermined type IOL. The haptics accommodation region 350 is defined by outer diameter side walls 360, which act as a protection wall to the received IOL. The shape and dimensions of the positioned guide slots 330 is determined according to the shape and dimensions of the IOL and the IOL haptics.

[0025] FIG.7 shows a perspective view of the extraocular clamping device with the clamping member 200 in open position according to embodiments of the present invention. Figure 7 shows the clamping body 100, the interchangeable IOL receiving insert 300, the fixing element 400 and the clamping member 200 in open position perpendicular to the longitudinal axis of the extraocular IOL clamping device, that permits the operator to place the IOL in interchangeable IOL receiving insert 300.

[0026] FIG.8 shows a perspective view of the extraocular clamping device with the clamping member 200 in closed position and the relative positions of the major parts of the device according to embodiments of the present invention. The interchangeable IOL receiving insert 300 and its relative position to the pressing region 230 of the clamping member 200 it is clearly visible.

[0027] FIG.9 shows an example of a typical Intraocular Lens (IOL) 500 that includes a central lenticular shaped optical portion 510, that usually has a diameter of six millimeters, the haptics of the lens 520, antidi ametrically positioned to the longitudinal axis of the lens,that serve to the fixing of the lens at position in the eye and usually are flat shaped elastic bands or threads. However, it should be noted that the present invention can be used with IOL of different dimensions.

[0028] FIG.10 shows an example of a toric IOL 600 according to embodiments of the present invention. A toric IOL has the same specifications as the IOL example of FIG.9, plus includes specific markings 610 on its periphery, as indicators of the toric axis. 610 markings has to be set on the interchangeable IOL receiving insert 300 in a specified orientation. This may be achieved by the help of a rotational IOL mechanism of the interchangeable IOL receiving insert.

[0029] Fig.l 1 shows a side view of an example of the clamping member 200 according to embodiments of the present invention. The pivot axis hole 240, the clamping region 220 of the clamping member 200 forming the area over the IOL pressing region230 having a thinned silhouette contour, as to provide clear field of view of the IOL optical region to the operator and also shaped in form to allow an interchangeable marking or piercing insert, to be locked on it, as to permit precise marking and / or piercing of an IOL at specified points, the rear portion 210 of the clamping member 200 that serves as an operators thumb griping area, or can be eliminated, as to form a shorter version of the clamping member 200, with less torque on the rear side of the pressing region 230, the pivot axis hole 240 that receive the fixing element 400 and the special profiled region, which acts as a rotation angle limiter 260 of the clamping member 200 in open position.

[0030] Fig.12 shows a perspective view of an example of a clamping member 200 of the extraocular IOL clamping device, with an interchangeable insert 700, mounted on the clamping region 220. The exemplified interchangeable insert 700, in this case, is configured as a piercing tool for performing an IOL pierce according to embodiments of the present invention. The interchangeable insert 700 comprises a pair of piercing needles 720, that are integrated in the piercing tool insert body at an ideal distance and orientation regard to the IOL, and the whole insert is locked in position by the help of the clipping action specific shaped regions of the two parts. It should be noted that the interchangeable insert 700 may be configured similarly as a marking or suturing tool according to embodiments of the present invention.

[0031] Fig.13 shows a detailed perspective view of the clamping region 220of the clamping member 200 of the extraocular IOL clamping device according to embodiments of the present invention. The clamping region 220 is shaped according to match the shape of the p interchangeable inserts 700, so that it permits the secure clipping of the inserts on it as to perform the specified actions .The clamping region 220 comprises a pressing region 230 that is provided with a specific shape which enables, when the clamping member 200 is in the closed position, to secure the IOL firmly in position, while not stressing the IOL, and allow the operator to perform a marking, piercing or suturing operation of an IOL. In essence, the interchangeable insert 700 is optional and the operator may select to use the clamping device of the present invention for accurately holding the IOL while performing the marking, piercing or suturing in a different way, e.g. via another tool or manually.

[0032] Fig.14 shows a perspective focused view of the front portion 160 part of extraocular IOL clamping device according to embodiments of the present invention. The clamping member 200 and the interchangeable IOL receiving insert 300 are omitted for clarity. The IOL receiving region 150, is provided with a shape that matches the shape of the interchangeable IOL receiving insert 300 tunnel and specific clipping aid profile, so as to secure the insert in position. The vertical, radius shape formed walls 140, support the interchangeable IOL receiving insert 300 in place and permit its optional rotational movement in the case of a tone version. The front portion 160 of the clamping body 100, support the rotational movement of the clamping member 200 and the side loads during the handling by the operator. The front end also includes the pivot hole 240 that receive the fixing element 400 that forms the pivot axis 420 and is designed to withstand the force of the fixing element 300 to the clamping member 200.

[0033] Fig. 15 shows a perspective view of an example of the interchangeable insert 700, which in this case is configured as a piercing tool according to embodiments of the present invention. The interchangeable insert 700 comprises high friction regions 730, that help the operator to apply with his fingers a downward force as to lock the interchangeable insert 700 in position and perform the desirable action on the IOL e.g. marking, piercing or suturing. The side walls 710, act as sliders on the sides of the clamping member 200, that guide the interchangeable insert 700 in its final position without side movement and tilting.The side walls 710 also include on the inner side, specific profile pins that matching respective guide slots on the sides of clamping member 200, as to ensure the precise vertical movement of the insert 700 in position. In the configuration shown in figure 15 of the interchangeable insert 300 as a piercing tool, the piercing needles 720 are permanently fixed in the sides of insert 700 at specific distance and orientation regarding the center of the IOL and they have a suitable length to reach the bottom of the IOL and extend beyond it at a safe length.

[0034] Fig.16 shows a top view of the exemplified interchangeable IOL receiving insert 300 of Figure 6. The interchangeable IOL receiving insert 300is configured to accommodate an IOL prior to perform marking, piercing or suturing action on it. Perpendicular to the longitudinal axis two antidiametrically positioned guide slots 330, have enough length and wide dimensions as to permit the handheld suturing needle, or al ternative, the piercing tool needles, to pass through and reach the opposite side of the IOL without obstruction problems and also ensuring the right radius distance of the hole and the angle, in respect of lens orientation. The protruding arch shaped guiding features 340 in antidiametrically positions in respect of the rotational axis of the IOL, forms an internal pocket that secure the optical diameter of the IOL disk and due to their position receive and lock the IOL haptics at specific anytime angle. An eccentric haptics accommodation region 350, is provided to accommodate the haptics of an IOL and the outer diameter side walls, 360 parts of the insert act as a protecti on wall to the accommodated IOL.

[0035] Fig.16a shows an example of an alternative type IOL interchangeable receiving insert 300a, which incorporates specifically placed notches 370a, configured to cooperate with corresponding locking pins 370b of an interchangeable IOL cover 380, for securing the interchangeable IOL cover 380 on the interchangeable IOL receiving insert 300a.

[0036] Fig.16b shows an example of an IOL interchangeable receiving insert cover 380, with its locking pins 370b and its guide slots 320b placed exactly on top of the corresponding guide slots 320 of an IOL interchangeable receiving insert 300a. The cover matches the shape of the IOL interchangeable receiving insert 300a, serves as a protector and guide for an IOL, and also takes the force applied by the clamping member 200.

[0037] Fig.16c shows a perspective view of a combination of an IOL interchangeable receiving insert 300a assembled with its cover 380. There also a clear view of the locking mechanism between the locking pins 370b on the cover 380 and cut out notches 370a on the IOL interchangeable receiving insert 300a.

[0038] Fig.l6d shows a perspective view of an example of an alternative IOL interchangeable receiving insert 300a, which is configured to house an alternative type of IOL 500d. This shows the customization ability of the IOL interchangeable receiving insert 300 or 300a, to receive any available type of IOL design.

[0039] Fig.17 shows an example of a suturing needle 800 that comprising a circle shaped metal tip and a flexible but strong long thread part 900 connected to the tip according to embodiments of the present invention. The operator has to insert the needle through the guide slots 330 of the interchangeable IOL receiving insert, prior to penetrate the optical disk of the IOL at the optimal radius that specified by the end of each guide slot 330.

[0040] FIG.18 shows a detailed top view of the front end of the extraocular IOL clamping device that represents the operators eye view over the IOL position on the device. The clamping region 220 at the center of the clamping member 200 has a slimline shape defined by the inward contoured profile compared to the other regions of the clamping member 200. The profile of the clamping region 220 permits unobstructed view of a predetermined portion of the IOL to the operator so as to perform the marking or piercing of the IOL. As shown in figure 18, when the clamping member 200 is in the closed position, the profile of the clampi ng region 200 enables the operator to view certain feature of the interchangeable IOL such as the receiving insert 300 with the guide slots 330, the IOL haptic fixers, the protruding arch shaped guiding features 340, the fixing element 400, the front portion 160 of the clamping body 100 that forms the pivot hinge of the rotational clamping member 200.

[0041] Fig .19 shows a top view of an example of interchangeable IOL receiving insert 300, with an IOL fitted in position, and the corresponding relative orientation of both the IOL and the receiving insert 300 according to embodiments of the present invention, the protruding arch shaped guiding features 340 and the outer diameter side walls 360, set the radius limits respectively, of the central optic disk of the IOL 510, and the outer ends ofthe IOL haptics 520. The position of protruding arch shaped guiding features 340, adapted to the occasional IOL shape and at fixed version are fixed placed in the haptics accommodation region 350, while at rotational -toric version follow the rotated IOL receiving plate.

[0042] Fig.20 shows a top view of the clamping device with the clamping member 200 in the closed position over the interchangeable IOL receiving insert 300 containing an IOL in position and a suturing needle 800 in position performing a suture action. The contoured profile of the clamping member 200 over the IOL, provides the operator with a clear view of the IOL operational area allowing for the unrestricted marking, piercing, or suturing of the IOL. Full protection of the sensitive parts of the IOL, like the haptics 520 and the optical disk area 510, is provided by the formed pockets and diaphragms on the insert, which is also clearly visible in figure 20. The clamping device of the present invention enables the operator to handle the IOL with unrestricted movements by one hand, in three axes, during marking, suturing or piercing of the IOL.

[0043] Fig.21 shows a top cross-sectional view of the pivot hinge of an example front portion 160 of the extraocular IOL handheld operated clamping device according to embodiments of the present invention. The front portion 160 of the clamping body 100 comprise two supporting wall, which defines a location for mounting the pivoting housing 250 of the clamping member 200. The front-end of the clamping member 200 is secured on the pivoting axis 420 which allows for clamping member 200 to pivot between the open and closed positions. A knurling formed knob 410 may be provided on one end of the pivoting axis 420, on the outside of one of the supporting walls, while the other end of the pivoting axis 420 comprises a male threaded region which is configured to interact with a female threaded opening on the opposing sidewall, when the knob 410 is rotated. In general, the pivoting axis 420 is arranged in the form of a screw, which configured by means of the rotational motion of the knob 410 to adjust the fixing torque applied to the clamping member 200 by the opposing sidewalls of the front portionl60.

[0044] In general, the present clamping device may be used in a sterile surgical field, where the surgeon takes the clamping device, loosens the fixing knob 400 and set the clamping member 200, at open position. After selecting the appropriate interchangeable IOLreceiving insert 300 for the available intraocular lens, the insert is placed in the tool holder; the intraocular lens is placed in the insert in the orientation resulting from the embossing of the insert. If required, the insert shall be rotated to obtain the desired position of the astigmatic axis. After confirming the correct position of the intraocular lens in relation to the guide slots 330 of the support sutures, the surgeon lowers the clamping member 200 to trap the intraocular lens in the desired position and rotates the fixing knob until clamping member 200 and insert-intraocular lens assembly is immobilized. The correct position of the suture guide slots 330 shall be checked again. Next, while the intraocular lens is held in position with one hand, the surgeon passes the support sutures successively through the points resulting from the position of the insertion notches. After the sutures have been passed through, their ends are cauterized to produce a small knot to prevent their passage through the suture passage hole. The intraocular lens is then released from the tool, removed from the tool and ready for insertion and surgical fixation.Reference numeral100 clamping body110 rear portion of the clamping body120 front end of rear portion of the clamping body130 bridge portion of the clamping body140 radius shape formed walls150 IOL receiving region for interchangeable IOL receiving Insert,160 front portion of the clamping body200 clamping member210 rear portion of the clamping member220 clamping region of the clamping member230 pressing region / clamping region of the clamping member240 pivot axis hole250 pivot housing of the clamping member260 rotation angle, limiter region300 interchangeable IOL receiving Insert300a alternative type of the interchangeable IOL receiving inser310 bottom channel, of the interchangeable IOL receiving Insert320 special profiled bottom, region of the interchangeable IOL receiving Insert330 guide slots, of the interchangeable IOL receiving Insert330b guide slots, of alternative type of the interchangeable IOL receiving insert340 protruding arch shaped guiding features of the interchangeable IOL receiving Insert350 haptics accommodation region of the interchangeable IOL receiving Insert360 outer diameter side walls of the interchangeable IOL receiving Insert370a cut out notches, of the interchangeable IOL receiving insert370b locking pins of the interchangeable IOL receiving insert380 interchangeable IOL receiving insert cover400 fixing element410 knob of the fixing element420 pivot axis430 male threaded portion500 Intraocular Lens (IOL)500d alternative type, of intraocular lens (IOL)optical region of an IOL haptics of an IOL toric IOL interchangeable insert side walls of a interchangeable insert piercing needles of an interchangeable insert high friction regions of a interchangeable insert suturing needle suturing thread

Claims

CLAIMS1. A clamping device for an Intraocular Lens, IOL, the clamping device comprising: a clamping body (100) comprising a rear portion (110) defining a handle member configured to be gripped by the user when holding the device, a front portion (160) , and a bridge portion (130) connecting the rear portion (110) and the front end portion; an interchangeable IOL receiving insert (300, 300a) mounted on an IOL receiving region (150) of the bridge portion (130), the interchangeable IOL receiving insert (300) being configured for receiving an IOL; a clamping member (200) mounted to the front end (160) of the clamping body via a pivot housing (250) providing at a front end of the clamping member (200) and configured to move with respect to the clamping body (100) between a closed and an open position, wherein the clamping member (200) comprises a clamping region ( 220) having a pressing region (230) configured, when the clamping member (200) is in the closed position, to apply a predetermine pressing force on t the interchangeable IOL receiving insert (300) so as to restrict movement of the IOL; and an interchangeable insert received at the clamping region (220) of the clamping member (200) configured for marking, piercing, or suturing the IOL.

2. The clamping device of claim 1, wherein at least a portion of the IOL receiving region (150) has a profile that is dimensioned to interlock with a corresponding channel (310) formed on a bottom region of the interchangeable IOL insert (300) so as to clip and secure the interchangeable IOL insert (300) to the IOL receiving region (150).

3. The clamping device of any one of claims 1 or 2, wherein the front end comprises a. fixing element (400) for securing the clamping member (200) in the pivoting housing of the front end portion.

4. The clamping device of claim 3, wherein the fixing element (400) forms a rotational hinge about which the clamping member (200) moves between the open and closed positions.

5. The clamping device of claim 3 or 4, wherein the fixing element (400) is configured to control the fixing force applied to the clamping member (200) by the sidewalls of the pivoting housing.

6. The clamping device of claim 5, wherein the fixing element (400) comprises a knob (410) having at an external surface a plurality of marking indicating the forced being applied by the rotational movement of the knob (410).

7. The clamping device of any one of the preceding claims, wherein the pivoting housing comprises a rear edge configured to engage with the clamping member (200) in the open position so as to restrict its movement.

8. The clamping device of any of the preceding claims, wherein the clamping region (220) has an inwardly formed contoured profile configured to provide a field of view of at least part of the IOL to the operator when the clamping member (200) is in the closed position.

9. The clamping device of any one of the preceding claims, wherein the interchangeable insert (700) comprises needles for piercing the IOL at predetermined locations. .

10. The clamping device of any one of the preceding claims, wherein the clamping region (220) has a profile that comprises locking features configured to interact with corresponding locking features provided on sidewalls (710) of the interchangeable insert (700) so as to clip and secure the interchangeable insert (700) on the clamping region11. The clamping device of any one of the preceding claims, wherein the handle member defined by the rear- portion (110) of clamping body (100) comprises friction gripping formed areas for controlling the positioning of the operator’s hand on the clamping body (100).

12. The clamping device of any one of the preceding claims, wherein the handle member defined by the rear portion (110) of the clamping body (100) comprises a flat bottom region configure to maintain the clamping device in a predetermined orientation when positioned on a bench surface, or under a microscope for free hand observation of the IOL.

13. The clamping device of any one of the preceding claims, wherein the rear portion (110) of the clamping body is configured to receive a rear portion of the clamping member (200) when in the closed position at a location between a front-end (120) of the rear portion (110) and the front portion (160) of the clamping body (100)14. The clamping device of any one of the preceding claims, wherein the interchangeable IOL receiving insert (300, 300a) comprises a top area defining a haptics accommodation region (350) dimensioned for accommodating the haptics of a predetermined type IOL, and a bottom region (320) defining a bottom channel (310) having a profile that is dimensioned to clip and secure the interchangeable IOL insert (300) to the IOL receiving region (150) of the clamping body (100).

15. The clamping device of claim 14, wherein the interchangeable IOL receiving insert (300a) comprises an interchangeable receiving insert cover (380) configured to receive the force applied by the clamping member (200) and protect and secure the IOL within the interchangeable IOL receiving insert.

16. The clamping device of claim 15, wherein the interchangeable IOL receiving insert (300a) comprises a plurality of notches (370a) configured to cooperate with corresponding locking pins (370b) of the interchangeable cover (380).

17. The clamping device of any one of claims 14 to 16, wherein the haptics accommodation region (350) comprises a pair of opposing guide slots (330) oriented perpendicular to a longitudinal axis of the clamping member (200), each guide slot (330) comprising an opening for receiving a suturing needle, wherein the guide slots (330) are positioned at a predetermine distance from the central pocket region.

18. The clamping device of any one of claims 14 to 17, wherein the interchangeable IOL receiving insert (300, 300a) comprises antidiametrically positioned guide slots 330 configured for guiding the needles for suturing the IOL.

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