Ophthalmic transfixing implants for use with intraocular lens, ophthalmic implantation tools for implanting same, and related methods

Abstract

Embodiments pertain to an ophthalmic transfixing implant for implantation in an eye with an implanted intraocular lens including a generally disc shaped lens body having an optical axis, the ophthalmic transfixing implant having a longitudinal centerline and comprising: a transfixing member having a proximal transfixing member end and a distal transfixing member end. The distal transfixing member end may include at least one tine for continuously transfixing the lens body. The proximal transfixing member end intended to have an ocular wall engaging member attached thereto for anchoring the ophthalmic transfixing implant to an eye's ocular wall thereby enabling a displaced implanted intraocular lens's optical axis to be aligned with an eye's visual axis. The distal transfixing member end may include a pair of spaced apart tines for transfixing the intraocular lens.

Description

OPHTHALMIC TRANSFIXING IMPLANTS FOR USE WITH INTRAOCULAR LENS, OPHTHALMIC IMPLANTATION TOOLS FOR IMPLANTING SAME, AND RELATED METHODS CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the priority and benefit from Israel patent application 305586, filed August 30, 2023, titled “OPHTHALMIC TRANSFIXING IMPLANT FOR USE WITH INTRAOCULAR LENS, OPHTHALMIC IMPLANTATION TOOL FOR IMPLANTING SAME, AND METHOD FOR ANCHORING AN INTRAOCULAR LENS IN A HUMAN EYE”, and which is incorporated herein by reference in its entirety. BACKGROUND

[0002] Intraocular lenses (IOLs) are implanted in human eyes as part of a treatment for cataracts or myopia after a natural lens has been removed. An intraocular lens is ideally implanted in a human eye such that its optical axis is co-axial with the human eye’s visual axis. An intraocular lens may become decentered and / or otherwise displaced from a human eye’s visual axis which impairs a human subject’s vision.

[0003] There is a need for repositioning intraocular lenses in human eyes.BRIEF DESCRIPTION OF DRAWINGS

[0004] In order to understand the invention and to see how it can be carried out in practice, embodiments will now be described, by way of non-limiting examples only, with reference to the accompanying drawings in which similar parts are likewise numbered, and in which:

[0005] Fig.1A are schematic front views of an ophthalmic implantation tool including an ophthalmic transfixing device and an intraocular lens, according to some embodiments.

[0006] Fig. 1B are greatly enlarged schematic front views of an ophthalmic transfixing implant according to some embodiments, and the ophthalmic transfixing implant transfixing the intraocular lens.

[0007] Fig.2A is a schematic longitudinal cross section of the ophthalmic implantation tool along line A-A in Fig.1A in its first operative state and close-up views of an encircled portion A and an encircled portion B. The distal end of the ophthalmic implantation tool is inside the patient's eye after passing through the capsule, with the grasper closed, adjacent an implanted intraocular lens, according to some embodiments.

[0008] Fig. 2B is as schematic cross-sectional view of an eye together with the tool in the position shown in Fig.2A.

[0009] Fig.3 is a schematic longitudinal cross section of the ophthalmic implantation tool along line A-A in Fig. 1A in its second operative state and close-up views of an encircled portion A and an encircled portion B. The distal end of the ophthalmic implantation tool is inside the patient's eye after passing through the capsule, with the grasper open, adjacent an implanted intraocular lens, according to some embodiments.

[0010] Fig.4 is a schematic longitudinal cross section of the ophthalmic implantation tool along line A-A in Fig. 1A in its third operative state and close-up views of the encircled portion A and the encircled portion B. The distal end of the ophthalmic implantation tool is inside the patient's eye after passing through the capsule, with the grasper open and the implanted intraocular lens between its jaws, according to some embodiments.

[0011] Fig.5 is a schematic longitudinal cross section of the ophthalmic implantation tool along line A-A in Fig.1A in its forth operative state for grasping the intraocular lens and close-up views of theencircled portion A and the encircled portion B. The distal end of the ophthalmic implantation tool is inside the patient's eye after passing through the capsule, with the grasper closed and the implanted intraocular lens between its jaws, according to some embodiments.

[0012] Fig.6 is a schematic longitudinal cross section of the ophthalmic implantation tool along line A-A in Fig.1A in its sixth operative state for transfixing the grasped intraocular lens and close-up views of the encircled portion A and the encircled portion B. The distal end of the ophthalmic implantation tool is inside the patient's eye after passing through the capsule, with the grasper closed and the implanted intraocular lens between its jaws, and the ophthalmic transfixing implant inserted into the implanted intraocular lens, according to some embodiments.

[0013] Fig.7 is a schematic longitudinal cross section of the ophthalmic implantation tool along line A-A in Fig. 1A its seventh operative state, releasing its grasp on the transfixed intraocular lens and close-up views of the encircled portion A and the encircled portion B. The distal end of the ophthalmic implantation tool is inside the patient's eye after passing through the capsule, with the grasper open and the implanted intraocular lens between its jaws, and the ophthalmic transfixing implant inserted into the implanted intraocular lens, according to some embodiments.

[0014] Fig. 8A is a schematic view showing a transfixed intraocular lens ready for anchoring to an ocular wall, according to some embodiments.

[0015] Fig.8B is a schematic view of an eye with a transfixed decentered intraocular lens, according to some embodiments.

[0016] Fig.8C is a schematic view of an eye with a transfixed re-centered intraocular lens, according to some embodiments.DETAILED DESCRIPTION

[0017] The relates to ophthalmic implants for use with intraocular lenses in general and repositioning of displaced (also: misaligned) intraocular lenses in human eyes in particular.

[0018] Embodiments of the present invention pertain to an ophthalmic transfixing implant configured for use with an intraocular lens comprising a generally disc shaped lens body having an optical axis and a disc radius.

[0019] In some embodiments, the ophthalmic transfixing implant has a longitudinal centerline and includes a transfixing member having a leading transfixing member end and a trailing transfixing member end. The leading transfixing member end includes at least one disc engagement element such as, for example, a tine, configured for transfixing or penetrating an intraocular lens, e.g., through piercing of the intraocular lens in a transversal direction, which may be about orthogonal to the lens’ optical axis. In some examples, the transfixing direction may be along a radius of the generally disc shaped lens body. Once the engagement element has transfixed the disc shaped lens body, it is configured to form-fittingly and / or frictionally engage with the disc-shaped lens body for preventing removal of the engagement element from within the disc-shape lens body.

[0020] The term “transfixing”, as well as grammatical variations thereof, may refer to any action by which the engagement element penetrates the disc shaped lens body such as, for example, through piercing, drilling, thrust into, boring, screwing, and / or the like, for fittingly and / or frictionally couple the disc shaped lens body with the ophthalmic transfixing implant.

[0021] In some examples, the trailing transfixing member end is configured to have an ocular wall engaging member attached or attachable thereto for anchoring the ophthalmic transfixing implant to a patient’s ocular wall, thereby enabling alignment with or otherwise operably position the intraocular lens’ optical axis relative to an eye’s visual axis Z.

[0022] The terms “proximal” and “distal” refer to locations which are correspondingly closer to a clinician implanting an ophthalmic transfixing implant and “distal” to locations which are located further therefrom.

[0023] The terms “longitudinal” and “axial” are interchangeable, and refer to an axis extending in the proximal and distal directions, unless otherwise expressly defined.

[0024] The terms “leading” and “trailing” refer to locations which are correspondingly closer to a clinician implanting an ophthalmic transfixing implant and further therefrom.

[0025] The terms “rearward” and “forward” refer to locations which are correspondingly closer to a clinician implanting an ophthalmic transfixing implant and further therefrom.

[0026] Ophthalmic transfixing implants optionally include at least one tine (e.g., a pair of spaced apart tines) for transfixing an intraocular lens, e.g., through piercing hereof. The at least one tine optionally includes at least one retaining feature for retaining an ophthalmic transfixing implant in a transfixed intraocular lens and preventing it from being dislodged therefrom. In some examples, the transfixing implant may be configured to be drilled into the disc shaped lens body.

[0027] In some examples, the trailing transfixing member end is configured for attachment of a fastener element such as, for example, a suture wire, a rod, and the like, constituting an ocular wall engaging member. Ophthalmic transfixing implants are optionally provisioned with a pre-attached ocular wall engaging member thereby facilitating an ophthalmic procedure.

[0028] In some embodiments, ophthalmic transfixing implants can be employed for operably repositioning an intraocular lens previously implanted in a patient’s eye and possibly having become decentered and / or otherwise displaced from its intended co-alignment with the patient’s eye’s visual axis, from an undesired to a desired position and / or orientation relative to the patient’s eye.

[0029] Additionally or alternatively, ophthalmic transfixing implants can be optionally employed for an initial implantation of an intraocular lens in a patient’s eye.

[0030] In some examples, devices and methods disclosed herein may be employed for the deployment, operable positioning and / or operable repositioning of toric lenses which are implanted to correct for cylinder defects, and / or for the deployment, operable positioning and / or operable repositioning of additional and / or other types of lenses.

[0031] Embodiments may also pertain to ophthalmic implantation tools for implanting an ophthalmic transfixing implant in a patient’s eye.

[0032] In some embodiments, the ophthalmic implantation tools include a pushrod for pushing an ophthalmic transfixing implant to (e.g., continuously) transfix an intraocular lens held stationary in a patient’s eye.

[0033] The pushrod can be manually and / or otherwise driven forward from a retracted storage position to an extended transfixing position. For example, the pushrod can be driven forward, for example, by a mechanical arrangement, an electro-mechanical arrangement, and / or the like. Ophthalmic implantation tools can be optionally pre-loaded with one or more sequentially deployable ophthalmic transfixing implants.

[0034] A transfixing implant may operable engage with the pushrod, e.g., as described herein. An ophthalmic implantation tool can be fashioned like a lance including a pushrod, for example, with an (e.g., pre-attached) ophthalmic transfixing implant, and, for example, a quick release mechanism for releasing the ophthalmic transfixing implant from the pushrod after it has transfixed an intraocular lens. Additionally or alternatively, the ophthalmic transfixing implant can be configured (e.g., lightly adhered to the pushrod) such that withdrawal of the pushrod from an operated eye leaves the ophthalmic transfixing implant transfixed into an intraocular lens.

[0035] An intraocular lens needs to be stationary in a human eye and securely held stationary for enabling it to be pierced by an ophthalmic transfixing implant. Such stationary securing can be achieved by conventional ophthalmic grasping forceps. An ophthalmic implantation tool can be optionally designed for single handed operation for both grasping and transfixing an intraocular lens.

[0036] An ophthalmic transfixing implant is necessarily implanted into an eye through an incision made in an ocular wall. An ophthalmic implantation tool loaded with an ophthalmic transfixing member can be designed for insertion through a previously prepared incision in an ocular wall. Alternatively, an ophthalmic implantation tool loaded with an ophthalmic transfixing implant can be designed to be, for example, trocar-like for puncturing an ocular wall directly.

[0037] Reference is made to Fig.1A. An ophthalmic implantation tool 1000 for use with an intraocular lens 10 of an eye 200 includes a generally disc shaped lens body 11 having an optical axis 12, an anterior lens surface 13, a posterior lens surface 14 opposite the anterior lens surface 13, and a peripheral lens surface 16 between the anterior lens surface 13 and the posterior lens surface 14.

[0038] In some embodiments, the intraocular lens 10 may include two outwardly protruding oppositely directed haptics 17 for assisting its placement in a vacated capsular bag of an operated eye. Additional or alternative configurations are also conceivable.

[0039] The lens body 11 may have an optic diameter, for example, in the range of 5 mm to 7 mm, an overall length, including the two outwardly protruding oppositely directed haptics 17, for example, in the range of 10 mm to 14 mm, and a maximum thickness along its optical axis 12, for example, in the range of 0.5 mm to 1.3 mm.

[0040] In some embodiments, the ophthalmic implantation tool 1000 has a longitudinal ophthalmic implantation tool centerline 1002 and includes a proximal implantation tool end 1004 and a distal ophthalmic implantation tool end 1006. The ophthalmic implantation tool 1000 includes a locally (e.g., clinician) and / or remotely (e.g., robotically) operated grasping arrangement 1008 with a pair of opposing jaws 1010 for grasping an intraocular lens 10 by its anterior lens surface 13 and posterior lens surface 14. The grasping arrangement 1008 can be implemented by normally open ophthalmic forceps. Alternatively, the grasping arrangement 1008 can be implemented by a normally closed ophthalmic forceps.

[0041] The ophthalmic implantation tool 1000 may have an overall length L of, for example, from about 15 cm to about 25 cm. The ophthalmic implantation tool 1000 may include a pushrod that may be operable together with or independent of the grasping arrangement 1008, for pushing an ophthalmic transfixing implant 1200 to pierce a grasped intraocular lens 10.

[0042] In some embodiments, the ophthalmic implantation tool 1000 can be pre-loaded with at least one ophthalmic transfixing implant 1200 provided in a sterile package ready for immediate use. In other embodiments, a clinician may be required to load an ophthalmic transfixing implant 1200 into an ophthalmic implantation tool 1000. The ophthalmic transfixing implant 1200 is initially deployed rearward of the grasping arrangement 1008 so as not to interfere grasping an intraocular lens 10.

[0043] As schematically shown in the top illustration of Fig. 1B, the ophthalmic transfixing implant 1200 has a longitudinal centerline 1202 and includes a transfixing member 1204 having a proximal transfixing member end 1206 and a distal transfixing member end 1208. The transfixing member 1204 may have an overall length L2 in the order of, for example, between about 0.5 mm to about 4 mm. The transfixing member 1204 may be manufactured from suitable bio-compatible materials, for example, medical grade metals (e.g., stainless steel), medical grade polymeric material, and / or the like.

[0044] In some embodiments, the distal transfixing member end 1208 has a pair of spaced apart barbed tines 1210 for transfixing an intraocular lens 10. The proximal transfixing member end 1206 is intended to have an ocular wall engaging member 1300 attached thereto for anchoring the ophthalmic transfixing implant 1200 to an eye’s ocular wall. In some examples, the ocular wall engaging member 1300 is conventional suture wire 1302 having two suture wire free ends 1304 and 1306. The proximal transfixing member end 1206 has a cross piece 1212 formed with a pair of throughgoing bores 1214 and 1216 for threading the suture wire 1302 therethrough such that the free suture wire ends 1304 and 1306 are oppositely directed to the distal transfixing member end 1208. The ophthalmic transfixing implant 1200 is optionally provisioned with a sufficient length of suture wire 1302 such that its free suture wire ends 1304 and 1306 remain external to an operated eye during a clinical procedure.

[0045] As schematically illustrated at bottom illustration of Fig. 1B, in some embodiments, the ophthalmic implantation tool 1000 is intended for insertion into a patient’s eye through an (e.g., pre- prepared) incision in an ocular wall. The ophthalmic implantation tool 1000 is intended to be initially manipulated towards an intraocular lens 10 and thereafter securely grasp it and maintain it stationary. Thereafter, the ophthalmic implantation tool 1000 is intended to push its ophthalmic transfixing implant 1200 to (e.g., continuously) transfix the intraocular lens 10 and release its grasp on the intraocular lens 10 before being removed from the patient’s eye leaving the ophthalmic transfixing implant 1200 transfixed in the intraocular lens 10. Finally, the ophthalmic transfixing implant 1200 is intended to be anchored to the eye’s ocular wall enabling the intraocular lens’s optical axis to be aligned with an eye’s visual axis. It is noted that in some examples, the incision is not pre- prepared but created by insertion of the ophthalmic implantation tool 1000 having a sufficiently sharp tip (e.g., sharp distal end of opposing jaws 1010).

[0046] As schematically shown in Fig. 2A, the ophthalmic implantation tool 1000 includes an elongated trailing implantation tool body 1012 and an elongated leading implantation tool extension 1014 correspondingly remaining external to a patient’s eye and intended for being inserted into a patient’s eye through an (e.g., pre-prepared) ocular incision during a clinical procedure.

[0047] In some examples, the elongated trailing implantation tool body 1012 may be handheld and / or robotically articulated.

[0048] The implantation tool body 1012 has a proximal implantation tool body end 1016 and a distal implantation tool body end 1018. The implantation tool extension 1014 has a proximal implantation tool extension end 1020 and a distal implantation tool extension end 1022.

[0049] For illustrative purposes, the implantation tool body 1012 has, for example, an overall length of between about 10 cm and about 23 cm, and the implantation tool extension 1014 has, for example, an overall length of between about 2 cm and about 5 cm. The implantation tool body 1012 has, for example, a diameter of between about 1cm to about 3 cm so that it can be comfortably handheld. The implantation tool extension 1014 has, for example, a diameter of about 0.4 mm to 1.5 mm, or any other diameter suitable for sliding insertion through an (e.g., pre-prepared) incision in an ocular wall.

[0050] The implantation tool body 1012 may include an internal implantation tool body member 1024 and an external implantation tool body member 1026 encircling the internal implantation tool body member 1024.

[0051] In some embodiments, the internal implantation tool body member 1024 may include a longitudinally directed U-shaped cut away 1028 at the distal implantation tool body end 1018 and directed towards the proximal implantation tool body end 1016 thereby defining a longitudinally directed internal implantation tool body member support 1030. The internal implantation tool body member support 1030 may have a leading internal implantation tool body member support end face 1032. The external implantation tool body member 1026 has an opposite pair of longitudinal directed slits 1034 extending from approximately midway therealong towards the distal implantation tool body end 1018, thereby defining an opposite pair of longitudinally directed (e.g., hand and / or robot- operatable) actuation members 1036.

[0052] In some embodiments, the implantation tool body 1012 includes a (e.g., generally cylindrical) end cap 1038 securely mounted on the internal implantation tool body member 1024 at the distal implantation tool body end 1018. The end cap 1038 includes a stepped throughgoing bore 1040 having a proximal wide diameter bore section 1042 and a distal narrow diameter bore section 1044, and a distal end cap face 1046.

[0053] In some embodiments, the implantation tool body 1012 includes a generally Y-shaped actuator 1048 having a box-shaped actuator body 1050, a pair of trailing actuator legs 1052, and a leading right cylindrical shaped actuator extension 1054. The box-shaped actuator body 1050 is normally juxtaposed against the leading internal implantation tool body member support end face 1032 with its pair of trailing actuator legs 1052 on opposite sides thereon. The actuator extension 1054 extends through the end cap 1038 and terminates at the distal end cap face 1046. The Y-shaped actuator 1048 includes a longitudinally directed throughgoing bore 1056.

[0054] In some examples, compression of the Y-shaped actuator 1048’s pair of trailing actuator legs 1052 towards the longitudinal ophthalmic implantation tool centerline 1002 urges the Y-shaped actuator 1048 in a distal direction towards a patient such that the box-shaped actuator body 1050 is spaced apart from the leading internal implantation tool body member support end face 1032. Release of the compression on the Y-shaped actuator 1048’s pair of trailing actuator legs 1052 enables the Y-shaped actuator 1048 to revert to its unflexed state.

[0055] In some examples, the implantation tool body 1012 includes a mechanical energy storage element, e.g., a compression spring 1058, deployed on the actuator extension 1054 and accommodated within the distal narrow diameter bore section 1044. The compression spring 1058 urges the Y-shaped actuator 1048 against the implantation tool body support end face 1032. Compression of the Y-shaped actuator 1048’s pair of trailing actuator legs 1052 towards the longitudinal ophthalmic implantation tool centerline 1002 urges the Y-shaped actuator 1048 to compress the compression spring 1058.

[0056] In some embodiments, the implantation tool extension 1014 includes two concentric implantation tool extension tubes as follows: an inner implantation tool extension tube 1060 and an outer implantation tool extension tube 1062 encircling the inner implantation tool extension tube 1060. The inner implantation tool extension tube 1060 has a proximal inner implantation tool extension tube end 1064 and a distal inner implantation tool extension tube end 1066. The outer implantation tool extension tube 1062 has a proximal outer implantation tool extension tube end 1068 and a distal implantation tool extension outer tube end 1070.

[0057] The inner implantation tool extension tube 1060 and the outer implantation tool extension tube 1062 both extend into the implantation tool body 1012 via the Y-shaped actuator 1048’s longitudinally directed throughgoing bore 1056.

[0058] The proximal inner implantation tool extension tube end 1064 is fixedly secured in the implantation tool body 1012 by a retainer screw 1013 such that it is stationary with respect thereto. The distal inner implantation tool extension tube end 1066 extends beyond the distal implantation tool extension outer tube end 1070 for terminating as the pair of normally open opposing jaws 1010.

[0059] The outer implantation tool extension tube 1062 is slidingly reciprocal on the inner implantation tool extension tube 1060 and its sliding reciprocation is imparted by movement of the Y-shaped actuator 1048. A retracted storage position of the outer implantation tool extension tube 1062 relative to the implantation tool body 1012 enables the distal inner implantation tool extension tube end 1066 to assume its nominal position as the pair of normally open opposing jaws 1010, as schematically shown in Fig.3 and Fig.4.

[0060] An extended actuation position of the outer implantation tool extension tube 1062 relative to the implantation tool body 1012 urges the pair of normally open opposing jaws 1010 to a grasping position for grasping the intraocular lens 10, schematically shown in Fig.5 and Fig.6.

[0061] The ophthalmic implantation tool 1000 includes an ophthalmic transfixing implant chute 1078 attached to the inner implantation tool extension tube 1060. The ophthalmic transfixing implant chute 1078 has a proximal ophthalmic transfixing implant chute end 1080 and a distal ophthalmic transfixing implant chute end 1082. The proximal ophthalmic transfixing implant chute end 1080 terminates about midway along the implantation tool extension 1014.

[0062] In some embodiments, the proximal ophthalmic transfixing implant chute end 1080 is attached to inner implantation tool extension tube 1060. The distal ophthalmic transfixing implant chute end 1082 terminates proximal to the distal inner implantation tool extension tube end 1066. The ophthalmic transfixing implant 1200 is placed inside the ophthalmic transfixing implant chute 1078, comparatively close, or adjacent, to the distal ophthalmic transfixing implant chute end 1082. The distal ophthalmic transfixing implant chute end 1082 optionally terminates flush with the distalimplantation tool extension outer tube end 1070 in the outer implantation tool extension tube 1062’s extended actuation position.

[0063] The ophthalmic implantation tool 1000 includes a longitudinally directed stepped pushrod throughgoing bore 1072 extending from the proximal implantation tool body end 1016 to the distal implantation tool extension end 1022. The longitudinally directed stepped pushrod throughgoing bore 1072 includes a proximal wide diameter pushrod throughgoing bore section 1074, a middle diameter pushrod throughgoing bore section 1076, and a distal narrow diameter pushrod throughgoing bore section 1075. The proximal wide diameter pushrod throughgoing bore section 1074 is going through the internal implantation tool body member 1024. The middle diameter pushrod throughgoing bore section 1076 is going through the inner implantation tool extension tube 1060. The distal narrow diameter pushrod throughgoing bore section 1075 is going through the ophthalmic transfixing implant chute 1078.

[0064] The ophthalmic implantation tool 1000 includes a pushrod 1084 extending from the proximal implantation tool end 1004 to the distal ophthalmic implantation tool end 1006. The pushrod 1084 includes a proximal pushrod end 1086 proximally protruding from the proximal implantation tool end 1004 by an actuation distance D. In some examples, the actuation distance D may be in the region of about 0.6 mm to 10 mm. As shown in Fig.2A, the pushrod 1084 includes a distal pushrod end 1088 terminating proximal to the ophthalmic transfixing implant 1200 at its initial location in the ophthalmic transfixing implant chute 1078.

[0065] In some examples, the pushrod 1084 includes a stepped configuration matching the longitudinally directed stepped pushrod throughgoing bore 1072. The pushrod 1084 includes a proximal wide diameter pushrod section 1090 going through the proximal wide diameter pushrod throughgoing bore section 1074, a middle diameter pushrod section 1092 going through the middle diameter pushrod throughgoing bore section 1076, and a distal pushrod end 1088 going through the distal narrow diameter pushrod throughgoing bore section 1075.

[0066] The pushrod 1084 undergoes a distal displacement equal to the actuation distance D. As shown in Fig.6, the pushrod 1084’s travel along the actuation distance slidingly urges the ophthalmic transfixing implant 1200 from the distal ophthalmic transfixing implant chute end 1082 to pierce a grasped intraocular lens 10.

[0067] Use of the ophthalmic implantation tool 1000 is now described:

[0068] Figs. 2A and 2B schematically show the ophthalmic implantation tool 1000’s in its first operative state as follows: The clinician compresses the (e.g., hand and / or robot operated) actuation members 1036 towards the longitudinal ophthalmic implantation tool centerline 1002 denoted by force arrows F such that they in turn compress the Y-shaped actuator 1048’s pair of trailing actuator legs 1052 also towards the longitudinal ophthalmic implantation tool centerline 1002. Compression of the Y-shaped actuator 1048’s pair of trailing actuator legs 1052 towards the longitudinal ophthalmic implantation tool centerline 1002 urges the Y-shaped actuator 1048 towards the distal implantation tool body end 1018, thereby compressing the compression spring 1058. The Y-shaped actuator 1048’s distal movement entrains the outer implantation tool extension tube 1062 therewith for urging the pair of normally open opposing jaws 1010 to a closed position.

[0069] The clinician inserts the implantation tool extension 1014 through an (e.g., pre-prepared) incision into a patient’s eye and penetrates the capsule 210. The pushrod 1084 is deployed in its retracted storage position such that the ophthalmic transfixing implant 1200 is stored in the ophthalmic transfixing implant chute 1078.

[0070] Fig.3 shows the ophthalmic implantation tool 1000’s in its second operative state as follows: The clinician releases compression of the (e.g., hand and / or robot operated) opposite pair of longitudinally directed actuation members 1036. This enables the Y-shaped actuator 1048’s pair of trailing actuator legs 1052 get back to their normally open position, which in turn lets the compression spring 1058 push the Y-shaped actuator 1048 proximally, until the box-shaped actuator body 1050 touches the leading internal implantation tool body member support end face 1032. The proximal displacement of the outer implantation tool extension tube 1062 attached to the Y-shaped actuator 1048 enables the distal inner implantation tool extension tube end 1066 to assume its nominal position of the pair of normally open opposing jaws 1010. The pushrod 1084 is deployed in its retracted storage position such that the ophthalmic transfixing implant 1200 is stored in the ophthalmic transfixing implant chute 1078.

[0071] Fig.4 shows the ophthalmic implantation tool 1000’s in its third operative state as follows: The clinician manipulates the ophthalmic implantation tool 1000 such that the distal ophthalmic transfixing implant chute end 1082 is adjacent an implanted intraocular lens 10 and possibly lightlybearing thereagainst, and the intraocular lens 10 is placed between the pair of normally open opposing jaws 1010

[0072] Fig.5 shows the ophthalmic implantation tool 1000’s in its forth operative state as follows: The clinician compresses the (e.g., hand and / or robot operated) actuation members 1036 towards the longitudinal ophthalmic implantation tool centerline 1002 denoted by force arrows F such that they in turn compress the Y-shaped actuator 1048’s pair of trailing actuator legs 1052 also towards the longitudinal ophthalmic implantation tool centerline 1002. Compression of the Y-shaped actuator 1048’s pair of trailing actuator legs 1052 towards the longitudinal ophthalmic implantation tool centerline 1002 urges the Y-shaped actuator 1048 towards the distal implantation tool body end 1018, thereby compressing the compression spring 1058. The Y-shaped actuator 1048’s distal movement entrains the outer implantation tool extension tube 1062 therewith for urging the pair of normally open opposing jaws 1010 to a grasping position for grasping the intraocular lens 10. The pushrod 1084 remains in its retracted storage position such that the ophthalmic transfixing implant 1200 remains stationary in the ophthalmic transfixing implant chute 1078.

[0073] Fig.6 shows the ophthalmic implantation tool 1000’s in its fifth operative state as follows: The clinician depresses the proximal pushrod end 1086 through its actuation distance for manually distally urging the ophthalmic transfixing implant 1200 out of the ophthalmic transfixing implant chute 1078 for transfixing the grasped intraocular lens 10, namely, its pair of spaced apart barbed tines 1210 forcibly pierce the intraocular lens body 11.

[0074] Fig.7 shows the ophthalmic implantation tool 1000’s in its sixth operative state as follows: The clinician releases compression of the (e.g., hand and / or robot operated) opposite pair of longitudinally directed actuation members 1036. This enables the Y-shaped actuator 1048’s pair of trailing actuator legs 1052 get back to their normally open position, which in turn lets the compression spring 1058 push the Y-shaped actuator 1048 proximally, until the box-shaped actuator body 1050 touches the leading internal implantation tool body member support end face 1032. The proximal displacement of the outer implantation tool extension tube 1062 attached to the Y-shaped actuator 1048 enables the distal inner implantation tool extension tube end 1066 to assume its nominal position of the pair of normally open opposing jaws 1010, thereby releasing their grasp on the transfixed intraocular lens 10.

[0075] Figs. 8A-8C show the clinician withdraws the ophthalmic implantation tool 1000 from the patient’s eye leaving the ophthalmic transfixing implant 1200 transfixed into the intraocular lens 10, allowing recentering of the IOL, as schematically shown in Fig.8C.

[0076] Withdrawal of the ophthalmic implantation tool 1000 leaves the suture wire ends 1304 and 1306 exterior to the operated eye for subsequent anchoring of the ophthalmic transfixing implant 1200 and the transfixed intraocular lens 10 to the ocular wall. Anchoring can include the use of a second ocular wall incision and manipulating one suture wire free end back into the operated eye and outwardly through the second ocular wall incision for tying with the other suture wire free end. The suture wire 1302 can be employed to manipulate the transfixed intraocular lens 10 relative to the patient’s eye for aligning its optical axis 12 with the eye’s visual axis Z. Two or more ophthalmic transfixing implants 1200 may be required to correctly align a transfixed intraocular lens 10 with an eye’s visual axis Z. The ophthalmic transfixing implants 1200 are typically inserted into a patient’s eye through different spaced apart incisions.

[0077] Additional Examples:

[0078] Example 1 pertains to an ophthalmic transfixing implant for implantation in an eye with an implanted intraocular lens including a generally disc shaped lens body having an optical axis, the ophthalmic transfixing implant having a longitudinal centerline and comprising:

[0079] a transfixing member having a proximal transfixing member end and a distal transfixing member end,

[0080] the distal transfixing member end including at least one disc engagement element configured to (e.g., continuously) transfix the lens body, and

[0081] the proximal transfixing member end intended to have an ocular wall engaging member attached thereto for anchoring the ophthalmic transfixing implant to an eye’s ocular wall thereby enabling a displaced implanted intraocular lens’s optical axis to be aligned with an eye’s visual axis.

[0082] Example 2 includes the subject matter of example 1 and, optionally, wherein the distal transfixing member end includes at least one tine and / or screw for transfixing the intraocular lens.

[0083] Example 3 includes the subject matter of examples 1 and / or 2 and, optionally, wherein the at least one disc engagement element includes at least one retaining feature for retaining the transfixing member in a transfixed intraocular lens.

[0084] Example 4 includes the subject matter of any one or more of the examples 1 to 3 and, optionally, wherein the proximal transfixing member end is configured for attachment of a suture wire constituting the ocular wall engaging member.

[0085] Example 5 includes the subject matter of any one or more of the examples 1 to 4 and, optionally, wherein the proximal transfixing member end is configured for attachment of a rod constituting the ocular wall engaging member.

[0086] Example 6 includes the subject matter of any one or more of the examples 1 to 5 and, optionally, wherein the ocular wall engaging member is pre-attached to the proximal transfixing member end.

[0087] Example 7 includes the subject matter of any one or more of the examples 1 to 6 and, optionally, wherein the at least one engagement element is configured such that, when transfixing the disc-shaped lens body, the at least one engagement element frictionally and / or form-fittingly engages with the disc-shaped lens body.

[0088] Example 8 pertains to an ophthalmic implantation tool for transfixing an ophthalmic transfixing implant in an implanted intraocular lens,

[0089] the intraocular lens including a generally disc shaped lens body having an optical axis, an anterior lens surface, a posterior lens surface opposite the anterior lens surface, and a peripheral lens surface between the anterior lens surface and the posterior lens surface,

[0090] the ophthalmic transfixing implant including a transfixing member having a proximal transfixing member end and a distal transfixing member end for transfixing an implanted intraocular lens,

[0091] the ophthalmic implantation tool having a longitudinal ophthalmic implantation tool centerline, a proximal ophthalmic implantation tool end and a distal ophthalmic implantation tool end,

[0092] the ophthalmic implantation tool comprising:

[0093] an elongated trailing implantation tool body and an elongated leading implantation tool extension correspondingly remaining external to an eye and intended for being inserted into an eye during a clinical procedure,

[0094] the implantation tool body having a proximal implantation tool body end and a distal implantation tool body end,

[0095] the implantation tool extension having a proximal implantation tool extension end and a distal implantation tool extension end,

[0096] a grasping arrangement with a pair of opposing jaws at the distal implantation tool extension end for selectively grasping the intraocular lens by its anterior lens surface and its posterior lens surface,

[0097] the implantation tool extension including an ophthalmic transfixing implant chute for accommodating the ophthalmic transfixing implant proximal to the pair of opposing jaws in its initial position in the ophthalmic transfixing implant chute,

[0098] a push rod longitudinally slidingly mounted in the ophthalmic implantation tool and having a distal push rod end terminating proximal to the ophthalmic transfixing implant in the ophthalmic transfixing implant chute,

[0099] the ophthalmic implantation tool being such that, in use, the grasping arrangement is operated to urge the pair of opposing clamps against the intraocular lens’ anterior lens surface and posterior lens surface to clamp the intraocular lens, and

[0100] the push rod is subsequently slidingly displaced to distally urge the ophthalmic transfixing implant towards the intraocular lens’ lens body for transfixing the distal transfixing member end in the lens body.

[0101] Example 9 includes the subject matter of example 8 and, optionally, wherein the pushrod includes a proximal pushrod end proximally protruding from the proximal implantation tool body end.

[0102] Example 10 includes the subject matter of examples 8 and / or 9 and, optionally, wherein the implantation tool body has an internal implantation tool body member and an external implantation tool body member encircling the internal implantation tool body member,

[0103] the external implantation tool body member having an opposite pair of longitudinal directed slits extending from midway towards the distal implantation tool body end thereby defining an opposite pair of longitudinally directed actuation members for actuating the grasping arrangement.

[0104] Example 11 includes the subject matter of example 10 and, optionally, wherein the longitudinally directed actuation members are outwardly biased with respect to the internal implantation tool body member whereby the grasping arrangement has a pair of normally open opposing jaws.

[0105] Example 12 pertains to an assemblage or kit comprising:

[0106] an ophthalmic transfixing implant according to any one or more of examples 1 to 7, and an ophthalmic implantation tool according to any one or more of examples 8 to 11.

[0107] Example 13 pertains to a method for anchoring an intraocular lens in a human eye, the intraocular lens having an optical axis, the human eye having a visual axis, the method comprising the steps of:

[0108] providing an ophthalmic transfixing implant including a longitudinal deployment axis comprising a transfixing member having at least one at least one disc engagement element configured to (e.g., continuously) transfix the intraocular lens;

[0109] grasping the intraocular lens for holding the intraocular lens stationary in the human eye;

[0110] pushing the ophthalmic transfixing implant for forcibly inserting the at least one disc engagement element into the stationary intraocular lens; and

[0111] employing an ocular wall engaging member for anchoring the ophthalmic transfixing implant to the eye’s ocular wall for enabling the intraocular lens’ optical axis be aligned with the eye’s visual axis.

[0112] Example 14 includes the method of example 13 and, optionally, wherein the ophthalmic transfixing implant includes at least one tine for transfixing the intraocular lens.

[0113] Example 15 includes the method of example 14 and, optionally, wherein the at least one (e.g., leading) tine includes at least one retaining feature for retaining the transfixing member in the transfixed intraocular lens.

[0114] Example 16 includes the subject matter of any one or more of the examples 13 to 15 and, optionally, wherein the transfixing member is configured for attachment of a suture wire constituting the ocular wall engaging member for anchoring the ophthalmic transfixing implant to the eye’s ocular wall.

[0115] Example 17 includes the subject matter of any one or more of the examples 13 to 16 and, optionally, wherein the transfixing member end is configured for attachment of a rod constituting the ocular wall engaging member for anchoring the ophthalmic transfixing implant to the eye’s ocular wall.

[0116] Example 18 includes the subject matter of any one or more of the examples 13 to 17 and, optionally, wherein the ocular wall engaging member is pre-attached to the transfixing member.

[0117] In the discussion, unless otherwise stated, adjectives such as “substantially” and “about” that modify a condition or relationship characteristic of a feature or features of an embodiment of the invention, are to be understood to mean that the condition or characteristic is defined to within tolerances that are acceptable for operation of the embodiment for an application for which it is intended.

[0118] Unless otherwise specified, the terms 'about' and / or 'close' with respect to a magnitude or a numerical value may imply to be within an inclusive range of -10% to +10% of the respective magnitude or value.

[0119] Unless otherwise specified, the terms 'about' or 'close' imply at or in a region of, or close to a location or a part of an object relative to other parts or regions of the object.

[0120] Positional terms such as "upper", "lower" "right", "left", "bottom", "below", "lowered", "low", "top", "above", "elevated", "high", "vertical" and "horizontal" as well as grammatical variations thereof as may be used herein do not necessarily indicate that, for example, a "bottom" component is below a "top" component, or that a component that is "below" is indeed "below" another component or that a component that is "above" is indeed "above" another component as suchdirections, components or both may be flipped, rotated, moved in space, placed in a diagonal orientation or position, placed horizontally or vertically, or similarly modified. Accordingly, it will be appreciated that the terms "bottom", "below", "top" and "above" may be used herein for exemplary purposes only, to illustrate the relative positioning or placement of certain components, to indicate a first and a second component or to do both.

[0121] “Coupled with” means indirectly or directly "coupled with”.

[0122] It is important to note that the method may include is not limited to those diagrams or to the corresponding descriptions. For example, the method may include additional or even fewer processes or operations in comparison to what is described herein. In addition, embodiments of the method are not necessarily limited to the chronological order as illustrated and described herein.

[0123] It should be understood that where the claims or specification refer to "a" or "an" element and / or feature, such reference is not to be construed as there being only one of that element. Hence, reference to “an element” or “at least one element” for instance may also encompass “one or more elements”.

[0124] As used herein the term "configuring" and / or 'adapting' for an objective, or a variation thereof, implies using materials and / or components in a manner designed for and / or implemented and / or operable or operative to achieve the objective.

[0125] Unless otherwise stated or applicable, the use of the expression “and / or” between the last two members of a list of options for selection indicates that a selection of one or more of the listed options is appropriate and may be made, and may be used interchangeably with the expressions “at least one of the following”, “any one of the following” or “one or more of the following”, followed by a listing of the various options.

[0126] As used herein, the phrase “A,B,C, or any combination of the aforesaid” should be interpreted as meaning all of the following: (i) A or B or C or any combination of A, B, and C, (ii) at least one of A, B, and C; and (iii) A, and / or B and / or C. This concept is illustrated for three elements (i.e., A,B,C), but extends to fewer and greater numbers of elements (e.g., A, B, C, D, etc.).

[0127] It should be appreciated that certain features, structures, characteristics, stages, methods, modules, elements, entities or systems disclosed herein, which are, for clarity, described in thecontext of separate examples, embodiments and / or the like, may also be provided in a suitable combination in a single example, embodiment, and / or the like. Conversely, various features, structures, characteristics, stages, methods, modules, elements, entities or systems disclosed herein, which are, for brevity, described in the context of a single example and / or embodiment, may also be provided separately or in any suitable sub-combination.

[0128] Throughout this application, various embodiments of this invention may be

[0129] 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.

[0130] 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” afirst indicate number and a second indicate number and “ranging / ranges from” afirst indicate number “to” a second indicate number are used herein interchangeably and are meant to include thefirst and second indicated numbers and all the fractional and integral numerals therebetween.

[0131] While the invention has been described with respect to a limited number of embodiments, it will be appreciated that many variations, modifications, and other applications of the invention can be made within the scope of the appended claims.

Claims

CLAIMS 1. An ophthalmic transfixing implant for implantation in an eye with an implanted intraocular lens including a generally disc shaped lens body having an optical axis, the ophthalmic transfixing implant having a longitudinal centerline and comprising: a transfixing member having a proximal transfixing member end and a distal transfixing member end, the distal transfixing member end including at least one disc engagement element configured to transfix the lens body, and the proximal transfixing member end intended to have an ocular wall engaging member attached thereto for anchoring the ophthalmic transfixing implant to an eye’s ocular wall thereby enabling a displaced implanted intraocular lens’s optical axis to be aligned with an eye’s visual axis.

2. The implant according to claim 1 wherein the distal transfixing member end includes at least one tine and / or screw for transfixing the intraocular lens.

3. The implant according to claim 1, wherein the at least one disc engagement element includes at least one retaining feature for retaining the transfixing member in a transfixed intraocular lens.

4. The implant according to claim 1, wherein the proximal transfixing member end is configured for attachment of a suture wire constituting the ocular wall engaging member.

5. The implant according to claim 1, wherein the proximal transfixing member end is configured for attachment of a rod constituting the ocular wall engaging member.

6. The implant according to claim 1, wherein the ocular wall engaging member is pre-attached to the proximal transfixing member end.

7. The implant according to claim 1, wherein the at least one engagement element is configured such that, when transfixing the disc-shaped lens body, the at least one engagement element frictionally and / or form-fittingly engages with the disc-shaped lens body.

8. An ophthalmic implantation tool for transfixing an ophthalmic transfixing implant in an implanted intraocular lens, the intraocular lens including a generally disc shaped lens body having an optical axis, an anterior lens surface, a posterior lens surface opposite the anterior lens surface, and a peripheral lens surface between the anterior lens surface and the posterior lens surface, the ophthalmic transfixing implant including a transfixing member having a proximal transfixing member end and a distal transfixing member end for transfixing an implanted intraocular lens, the ophthalmic implantation tool having a longitudinal ophthalmic implantation tool centerline, a proximal ophthalmic implantation tool end and a distal ophthalmic implantation tool end, the ophthalmic implantation tool comprising: an elongated trailing implantation tool body and an elongated leading implantation tool extension correspondingly remaining external to an eye and intended for being inserted into an eye during a clinical procedure, the implantation tool body having a proximal implantation tool body end and a distal implantation tool body end, the implantation tool extension having a proximal implantation tool extension end and a distal implantation tool extension end, a grasping arrangement with a pair of opposing jaws at the distal implantation tool extension end for selectively grasping the intraocular lens by its anterior lens surface and its posterior lens surface, the implantation tool extension including an ophthalmic transfixing implant chute for accommodating the ophthalmic transfixing implant proximal to the pair of opposing jaws in its initial position in the ophthalmic transfixing implant chute,a push rod longitudinally slidingly mounted in the ophthalmic implantation tool and having a distal push rod end terminating proximal to the ophthalmic transfixing implant in the ophthalmic transfixing implant chute, the ophthalmic implantation tool being such that, in use, the grasping arrangement is operated to urge the pair of opposing clamps against the intraocular lens’ anterior lens surface and posterior lens surface to clamp the intraocular lens, and the push rod is subsequently slidingly displaced to distally urge the ophthalmic transfixing implant towards the intraocular lens’ lens body for transfixing the distal transfixing member end in the lens body.

9. The ophthalmic implantation tool according to claim 8 wherein the pushrod includes a proximal pushrod end proximally protruding from the proximal implantation tool body end.

10. The ophthalmic implantation tool according to claim 8, wherein the implantation tool body has an internal implantation tool body member and an external implantation tool body member encircling the internal implantation tool body member, the external implantation tool body member having an opposite pair of longitudinal directed slits extending from midway towards the distal implantation tool body end thereby defining an opposite pair of longitudinally directed actuation members for actuating the grasping arrangement.

11. The ophthalmic implantation tool according to claim 10 wherein the longitudinally directed actuation members are outwardly biased with respect to the internal implantation tool body member whereby the grasping arrangement has a pair of normally open opposing jaws.

12. An assemblage comprising: a) an ophthalmic transfixing implant according to claim 1, and b) an ophthalmic implantation tool according to claim 8.

13. A method for anchoring an intraocular lens in a human eye, the intraocular lens having an optical axis, the human eye having a visual axis, the method comprising the steps of: a) providing an ophthalmic transfixing implant including a longitudinal deployment axis comprising a transfixing member having at least one at least one disc engagement element configured to (e.g., continuously) transfix the intraocular lens; b) grasping the intraocular lens for holding the intraocular lens stationary in the human eye; c) pushing the ophthalmic transfixing implant for forcibly inserting the at least one at least one disc engagement element into the stationary intraocular lens; and d) employing an ocular wall engaging member for anchoring the ophthalmic transfixing implant to the eye’s ocular wall for enabling the intraocular lens’ optical axis be aligned with the eye’s visual axis.

14. The method according to claim 13 wherein the ophthalmic transfixing implant includes at least one tine for transfixing the intraocular lens.

15. The method according to claim 14, wherein the at least one leading tine includes at least one retaining feature for retaining the transfixing member in the transfixed intraocular lens.

16. The method according to claim 13, wherein the transfixing member is configured for attachment of a suture wire constituting the ocular wall engaging member for anchoring the ophthalmic transfixing implant to the eye’s ocular wall.

17. The method according to claim 13, wherein the transfixing member end is configured for attachment of a rod constituting the ocular wall engaging member for anchoring the ophthalmic transfixing implant to the eye’s ocular wall.

18. The method according to claim 13, wherein the ocular wall engaging member is pre-attached to the transfixing member.

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