WO2018191816A1

WO2018191816A1 - Intraocular lens fixation device

Info

Publication number: WO2018191816A1
Application number: PCT/CA2018/050460
Authority: WO
Inventors: Matthew Anderson
Original assignee: Matthew Anderson
Priority date: 2017-04-18
Filing date: 2018-04-17
Publication date: 2018-10-25

Abstract

An intraocular lens fixation device is herein disclosed, the device having an optic lens element, at least two haptics attached to the optic element, and a flexible member having a first end attached to the haptic and a second end attached to a connector member. The flexible member may be a surgical thread and the connector member may be configured for attachment to a needle.

Description

INTRAOCULAR LENS FIXATION DEVICE

CROSS REFERENCE TO RELATED APPLICATION

[0001] This application claim priority to United States Patent Application US 62/486,655, the entire contents of which is hereby incorporated by reference.

FIELD

[0002] The present disclosure relates generally to an intraocular lens fixation device.

BACKGROUND

[0003] There exist various ways of securing an intraocular lens in the eye.

[0004] If the original lens capsule is present and intact, then an intraocular lens can be secured in the lens capsule. This may be referred to as securing the intraocular lens within the capsular bag. Intraocular lenses can include securing devices such as haptics, which are narrow support struts; or plates. Haptics are typically two curved arms extending outwards from a central lens optic.

[0005] If insertion of an intraocular lens into the capsular bag is not possible due to rupture of the posterior capsule for example, then it may be possible to secure an intraocular lens by positioning the haptics in the ciliary sulcus.

[0006] If adequate capsular support for an intraocular lens is not available due to degeneration, removal, absence/partial absence of the lens capsule, or zonular weakness/loss, further methods of securing an intraocular lens can be considered. These include anterior chamber intraocular lens insertion, iris claw lens fixation, iris sutured lenses, sutured scleral fixation of posterior chamber intraocular lenses, and scleral tunneling of intraocular lens haptics.

[0007] Various problems can arise with these fixation methods. Problems include positional problems: dislocation, decentration, subluxation, luxation of the intraocular lens; problems related to sutures, such as irritation, suture erosion, suture tearing, suture slippage or suture breakage. In addition, some of these methods are technically difficult and slow to perform.

[0008] There remains a need for an intraocular lens fixation device. SUMMARY

[0009] In one aspect, there is described an intraocular lens fixation device, comprising: an intraocular lens comprising an optic element; at least two haptics attached to said optic element, each said haptic comprising a first end and a second end, each said first end of said haptic attached to said optic element; and a flexible member having a first end and a second end, said first end of said flexible member is attached to said second end of said haptic, the second end of said flexible member comprising a connector member.

[0010] In one aspect, there is described an intraocular lens fixation device, comprising: at least two haptics, each said haptic comprising a first end and a second end; and a flexible member having a first end and a second end, said first end of said flexible member is attached to said second end of said haptic, the second end of said flexible member comprising a connector member.

[0011] In one example, further comprising an intraocular lens comprising an optic element, each said first end of said haptic attached to said optic element

[0012] In one example, said flexible member is fixedly attached to said haptic.

[0013] In one example, said flexible member comprises thread, preferably surgical thread.

[0014] In one example, said flexible member comprises nylon, polypropylene, silk, polyester, the like, or combinations thereof.

[0015] In one example, said flexible member is biodegradable or resorbable, or both biodegradable and resorbable.

[0016] In one example, said flexible member comprises collagen, polyglycolide, polydioxanone, polyglactin 910, or mixtures thereof.

[0017] In one example, said flexible member comprises indicia, preferably colour coding indicia.

[0018] In one example, said connector member of said flexible member is configured for attachment to a needle, preferably a tunnel needle, more preferably a scleral tunnel needle.

[0019] In one example, said optic element and said at least two haptics are made of the same material.

[0020] In one example, said optic element and said at least two haptics are made of optically transmissive material. [0021] In one aspect there is described an intraocular lens fixation system, comprising: an intraocular lens fixation device according to any preceding claim, and a scleral tunnel needle.

[0022] In one aspect there is described a kit, comprising: an intraocular lens fixation device according to any one of claims 1 to 17, and instructions for use.

[0023] In one example, further comprising a scleral tunnel needle.

[0024] In one aspect, there is described a kit comprising: an intraocular lens fixation device according to any preceding claim, and a scleral tunnel needle, and optionally instructions for use.

[0025] In one aspect there is described a method of manufacturing an intraocular lens fixation device, comprising: attaching a first end of flexible member to the second end of a haptic attached to an optic element.

[0026] In one example, a second end of said flexible member comprises a connector.

[0027] In one example, said attaching is effected using a glue.

[0028] In one example, said flexible member comprises thread, preferably surgical thread.

[0029] In one example, said flexible member comprises nylon, polypropylene, silk, polyester, the like, or combinations thereof.

[0030] In one example, wherein said flexible member comprises indicia, preferably colour coding indicia.

[0031] In one example, said flexible member is biodegradable or bioabsorbable, or biodegradable and bioabsorbable.

[0032] In one example, said connector member of said flexible member is configured for attachment to a needle, preferably a tunnel needle, more preferably a scleral tunnel needle.

[0033] In one aspect there is described an intraocular lens fixation device made according to a method of any one of claims 17 to 24.

[0034] In one aspect there is described a use of a fixation device according to any one of claims 1 to 17, for implanting an intraocular lens in the eye of a subject, preferably the subject is an animal, preferably the subject is a mammal, more preferably the subject is a human.

[0035] In one aspect there is described a method of implanting an intraocular lens into an eye of a subject, comprising: placing an intraocular lens fixation device according to any one of claims 1 to 17 in the eye of said subject, securing the second end of each said haptic of said fixation device within a scleral tunnel in the eye of said subject.

[0036] In one example, said scleral tunnel is produced by passing a scleral tunnel needle through the sclera of said eye, said scleral tunnel needle has a first pointed end and a second attachment end, and the connector member of said fixation device is removably or fixedly attached to said second attachment end.

BRIEF DESCRIPTION OF THE FIGURES

[0037] Embodiments of the present disclosure will now be described, by way of example only, with reference to the attached Figures.

[0038] Figure 1 is a frontal view of an intraocular lens.

[0039] Figure 2 is a side view of an intraocular lens.

[0040] Figure 3 is a side view of a scleral tunnel needle.

[0041] Figure 4 is a plan view of the scleral tunnel needle.

[0042] Figure 5 is an end view of the scleral tunnel needle connector.

[0043] Figure 6 is a front view of an eye during surgical placement of the intraocular lens.

[0044] Figure 7 is a front view of an eye.

[0045] Figure 8 is a front view of an eye.

[0046] Figure 9 is a front view of an eye.

[0047] Figure 10 is a front view of an eye.

[0048] Figure 1 1 is a front view of an eye.

[0049] Figure 12 is a front view of an eye.

[0050] Figure 13 is a sagittal view of an eye.

[0051] Figure 14 is a front view of an eye.

DETAILED DESCRIPTION

[0052] Described herein is an intraocular lens fixation device, an intraocular fixation system, a kit, a method of manufacturing an intraocular lens fixation device, uses thereof, and a method of implanting an intraocular device.

[0053] In one aspect, there is provided an intraocular lens fixation device, comprising: an intraocular lens comprising an optic element; at least two haptics attached to said optic element, each said haptic comprising a first end and a second end, each said first end of said haptic attached to said optic element; and a flexible member having a first end and a second end, said first end of said flexible member is attached to said second end of said haptic, the second end of said flexible member comprising a connector member.

[0054] In one aspect, there is provided an intraocular lens fixation device, comprising: at least two haptics, each said haptic comprising a first end and a second end; and a flexible member having a first end and a second end, said first end of said flexible member is attached to said second end of said haptic, the second end of said flexible member comprising a connector member. In one example, the intraocular lens fixation device, further comprising an intraocular lens comprising an optic element, each said first end of said haptic attached to said optic element.

[0055] The term "intraocular lens" (also referred to as IOL), as used herein, refers to a lens manufactured to be implanted into the eye. In some examples, the intraocular lens is implanted in place of the natural crystalline lens.

[0056] When the natural lens is removed from the eye, an intraocular lens (IOL) can be implanted in the eye to assist the eye in focusing light onto the retina. Intraocular lenses may provide one or more fixed focusing performances.

[0057] The term "haptic" as used herein refers to a mechanical structure or element that helps to maintain an intraocular lens in a defined position in an eye. Haptics are also referred to as "struts", "fixation elements", and "supports", in the art. In one example, a haptic is used to rigidly hold a lens in place. In one example, a haptic is used as a spring to keep a lens centered. In one example, the haptics are apposed against an inner surface of an eye and mounted to a lens structure to securely position a lens in the optical path of an eye.

[0058] As noted above, the device comprises a flexible member having a first end and a second end, said first end of said flexible member is attached to said second end of said haptic, the second end of said flexible member comprising a connector member. In some examples, the flexible member is also referred to as a haptic thread.

[0059] In one example said flexible member is attached to said haptic using glue.

[0060] In one example, said flexible member comprises thread, preferably surgical thread.

[0061] In one example, the flexible member comprises nylon, polypropylene, silk, polyester, the like, or combinations thereof.

[0062] In one example the flexible member is biodegradable or resorbable, or both biodegradable and resorbable.

[0063] In one example, the flexible member comprises collagen, polyglycolide, polydioxanone, polyglactin 910, or mixtures thereof. [0064] In one example, the flexible member comprises indicia, preferably colour coding indicia.

[0065] In some examples, the haptic and/or the flexible member may be colour coded for length to aid alignment. For example, black and white bars along the length may be used to visually gauge the symmetry of positioning between two or more haptics.

[0066] In one example, the connector member of said flexible member is configured for attachment to a needle, preferably a tunnel needle, more preferably a scleral tunnel needle.

[0067] A haptic can be a variety of shapes and sizes depending on the location the intraocular lens is to be implanted in the eye. In non-limiting examples, haptics may be C-shaped, J-shaped, or other designs.

[0068] In some examples, the haptics may be of open or closed configuration and may be planar, angled, or step-vaulted.

[0069] In one example, an optic element has at least two haptics attached to it. In other examples, the optic element has at least one haptic, at least two haptics, at least three haptics, at least four haptics, at least five haptics, at least six haptics, or more than six haptics, attached to it. It will be appreciated that the number of haptics may vary depending on the design, configuration, and implant location of the lens.

[0070] If the optic element does not have a haptic attached to it, a haptic may be attached to said optic element. If the optic element does not have a sufficient number of haptics attached to it, one or more haptics may be further attached.

[0071] Haptics may be made of a continuous material as the optic element of the intraocular lens or may be structurally associated with the optic element.

[0072] Suitable materials for a haptic will be known to the skilled worker. In one example, the haptic is made of an optically transmissive material.

[0073] Typically, a haptic is arranged peripherally to the optic element.

[0074] In some examples, the haptic is substantially in the same plane as the optic element. In some examples, the haptic is not in the same plane as the optic element. In some examples, the haptic is vaulted forward or backwards relative to the optic element.

[0075] The term "optic element" or "optic" as used herein refers to the component(s) within the intraocular lens that cumulatively enable the intraocular lens to focus the light. [0076] In some examples, an optic element is made of a molded polymer or a hydrated polymer gel and each haptic comes out of the optic to adjoin the lens to the capsule or iris or sclera.

[0077] In some examples, an intraocular lens is made of a hard plastic material such as polymethylmethacrylate (PMMA), or of either a soft hydrated polymer such as poly(2-hydroxyethylmethacrylate) and poly(N-vinyl-2-pyrrolidone) or a soft non-hydrated material such as silicon rubber and acrylic rubber. In some examples, the intraocular lens is made of materials including acrylics, acrylates, poly siloxanes, water absorbing acrylates such as polyhydroxyethylmethyacrylate (Poly HEMA), polyvinyl alcohol (PVA), or combinations thereof.

[0078] In one example, the optic element can include an optical chamber and optical fluid within such chamber, as well as one or more physical lens structures.

[0079] In one example, an intraocular lens may be a fixed monofocal lens matched to distance vision, or to near vision, or to an intermediate distance. In another example, the intraocular lens is multifocal to provide the subject with multiple-focused vision at far and/or intermediate and/or reading distance. In another example, the intraocular lens is an adaptive lens which provides the subject with limited visual accommodation.

[0080] In one example, an intraocular lens is a toric IOL. A toric intraocular lens has an optic element which is able to correct for astigmatism. In one example the astigmatism is regular astigmatism, where the axes are at 90 degrees to each other.

[0081] In some examples, the optic element will not have a uniform refractive power, but will have a particular power in one axis, and a different power in another axis, typically at right angles to it.

[0082] In use, an intraocular lens may provide optical correction or modification, or may be cosmetic (e.g., iris colour).

[0083] In one example, an intraocular lens may be used to treat or correct a refractive error.

[0084] In one example, the intraocular lens may be used to treat a cataract, or myopia, or hyperopia also.

[0085] In some examples, the intraocular lens is a pseudophakic intraocular lens.

For example, the intraocular lens may be implanted during cataract surgery, after the cloudy crystalline cataract lens has been removed. The pseudophakic intraocular lens replaces the original crystalline lens, and provides the light focusing function originally undertaken by the crystalline lens. [0086] The term "subject" as used herein, refers to an animal, and can include, for example, domesticated animals, such as cats, dogs, etc., livestock (e.g., cattle, horses, pigs, sheep, goats, etc.), laboratory animals (e.g., mouse, rabbit, rat, guinea pig, etc.), mammals, non-human mammals, primates, non-human primates, rodents, birds, reptiles, amphibians, fish, and any other animal.

[0087] In a specific example, the subject is a human.

[0088] Methods described herein are conveniently practiced by providing the compounds and/or compositions used in such method in the form of a kit. Such kit preferably contains the composition. Such a kit preferably contains instructions for the use thereof.

[0089] To gain a better understanding of the invention described herein, the following examples are set forth. It should be understood that these examples are for illustrative purposes only. Therefore, they should not limit the scope of this invention in any way.

EXAMPLES

[0090] In one example of the intraocular lens fixation device, an intraocular lens comprises a central optic element which is a light refracting optic for vision correction. The optic element is attached to one or more haptics which extend outwards from the optic element. The haptics are semi-flexible and can resiliently flex during surgical insertion and can conform to the geometry of the eye, but have sufficient stiffness to retain their shape and provide mechanical support for the optic element. Preferably, the haptic does not bend back on itself, kink, or be subject to sharp curves.

[0091] Various shapes of haptic are possible. In one example, the haptic is a narrow filament member which extends outwards with a moderate curvature in the plane of the optic. Optionally, the haptic is an integral part of the optic and formed from the same material. Alternatively the haptic is separate element which may be securely attached to the optic element.

[0092] The haptic comprises a first end and a second end.

[0093] In one example, first end of the haptic is attached to the optic element.

[0094] The second end of the haptic is attached to a flexible member. In some examples, the flexible member is also referred to as a haptic thread.

[0095] The flexible member has a first and second end. The first end of the flexible member is attached to the second end of the haptic.

[0096] The flexible member has significantly greater flexibility than the haptic. [0097] In some examples, the flexible member is similar to a suture thread and may be made of suture materials such as nylon, polypropylene, silk, or polyester. The flexible member has sufficient tensile strength to aid surgical positioning of the intraocular lens, but does not need to provide continued mechanical support of the intraocular lens. The flexible member has significant flexibility and can be kinked or folded back on itself without significant damage.

[0098] The flexible member may be handled during surgery and thereby reduce the risk of damaging, deforming, or breaking the haptic by handling the haptic directly, such as crimping damage by gripping with forceps, or breakage or kinking due to inadvertent twisting or bending during surgery. Thus, in some examples, the flexibility of the flexible member shields the haptic from damaging manipulation. The flexible member allows positional control of the intraocular lens during surgery. Further, the flexible member allows the haptics to be drawn into scleral tunnels. The flexible member can be used for fine position adjustment of the intraocular lens. In some examples, the flexible member is sacrificial, and all or part of it can be removed at the end of surgery.

[0099] The second end of the flexible member comprises a connector component, for convenient connection to a scleral tunnel needle. This connection may be reversible or fixed. Various forms of connector are possible, for example, the connector may be a ball or puck-shape which fits into a corresponding component on the scleral tunnel needle. Optionally, the connector component is integrally formed from the same material as the flexible member.

[00100] A scleral tunnel needle may be used for making a tunnel in the sclera of the eye. It has a sharp end which may be in the form of a round point, a curved cutting point, a taper cutting point, or a cutting spatula for example.

[00101] In some examples, one or more portions of the shank of the scleral tunnel needle may be flattened for better holding using a needle holder.

[00102] The scleral tunnel needle may have a curvature to allow controlled manipulation during forming of the scleral tunnel. The trailing end of the scleral tunnel needle comprises a connector end for removable or fixed attachment to the connector member of the flexible member.

[00103] It will be appreciated that various shapes of connector ends are possible. In one example, the connector end is a generally circular aperture in the shank of the needle near the end which adjoins a narrow slit in the shank of the needle and extends to the end of the needle. [00104] In this way it is possible to quickly and easily insert the generally ball- shaped or generally puck-shaped connector member of the flexible member into the connector end of the scleral tunnel needle, with the flexible member exiting the scleral tunnel needle via a slit in the back of the needle. It will be appreciated that a variety of shapes for the connector end may be used.

[00105] The scleral tunnel needle and flexible member may then be connected in a manner that is substantially smooth and has no (or sufficiently few) parts which project radially from the needle and would risk damaging or enlarging the scleral tunnel during transit through the tunnel.

[00106] Alternate forms of slender connection may include a slit or axial hole in the needle into which the flexible member can be placed and then secured by crimping.

[00107] In some examples, an eyelet in the scleral tunnel needle - such as a conventional sewing needle - is possible. However, this may be less desirable because the diameter of the needle increases in the vicinity of the eyelet, and the suture thread can extend outwards to also increase the diameter of the combined needle and thread. This increased diameter risks enlarging the scleral tunnel.

[00108] In one example, in use, the connector member is generally ball-shaped on the second end of the flexible member. This can be fed into and secured in the end of a scleral tunnel needle. The needle may have a gentle curve.

[00109] The flexible member described herein may have some or all of the following non-limiting features. The flexible member is more flexible than the haptic. The flexible member may be made of the same material as the haptic. The flexible member may be made of different material from that of the haptic. The flexible member may have a diameter that is the substantially the same as the haptic, or may have a diameter that is different than the haptic. The flexible member may have a diameter that is less than the diameter of the haptic. The flexible member may be of generally uniform diameter, or have a variable and/or tapering diameter. The flexibility and diameter characteristics of the flexible member are such that the flexible member can be grasped along its length with a vitreoretinal forceps and pulled out of the eye through a vitreoretinal surgical cannula, which is 23G or smaller, even though the flexible element may be folded on itself when this maneuver is performed, without causing significant damage to the flexible element. If no cannula is used, the flexibility and diameter characteristics of the flexible member are such that it can be grasped along its length with vitreoretinal forceps and pulled out of the eye without causing significant tissue damage. [00110] In one example, the flexible member had a diameter of approximately

0.05mm.

[00111] The flexible member may have a variable length.

[00112] The flexible member may have indicia, such as length markers. This may comprise coloured marks on the flexible member; or equal length segments may have different colours. In some examples, the flexible member comprises marks to indicate the orientation of the flexible member. For example, coloured marks may be made on the upper surface of the flexible member which help to identify if the flexible member has been twisted as it is externalized from inside the eye.

[00113] The second end of the flexible member comprises a connector member which can be removably or fixedly attached to the trailing end of a scleral tunnel needle, after the flexible member has been passed through the eye.

[00114] Thus, the flexible member allows the procedure to be performed without needing to grasp a haptic with vitreoretinal forceps, thereby minimizing the risk of damage to the haptic.

[00115] The flexible member also allows the haptic to be drawn into an intra-scleral tunnel created by the passage of the scleral tunnel needle.

[00116] The haptic described herein may have some or all of the following non- limiting features.

[00117] The haptic is more rigid than the flexible member.

[00118] The haptic may be made from the same or a different material as the optic

1. e. it may resemble a "one-piece" or "three-piece" intra-ocular lens (IOL) in this respect.

[00119] The haptic may be ribbed/serrated or have nodular protrusions from its surface to facilitate securing it intra-sclerally.

[00120] The haptic may have a variable length, curvature, and/or anterior/posterior vault with respect to the optic.

[00121] The haptic may have length markers; this may comprise coloured marks on the segment; or equal length segments may have different colours.

[00122] As noted above, the function of the haptic is to hold the optic in position though the haptic's positioning within the sclera

[00123] The scleral tunnel needle described herein may have some or all of the following non-limiting features.

[00124] The scleral tunnel needle may have a variable length, diameter, curvature and profile [00125] A portion of the body of the scleral tunnel needle may have a flattened profile to facilitate grasping the needle with a needle-holding forceps.

[00126] The trailing part of the scleral tunnel needle may have a modification which permits a connector member to be removably or fixedly attached to the scleral tunnel needle. The connector member may be pushed through/into an opening on the trailing part of the scleral tunnel needle and then secured in place by pulling it towards the trailing tip of the needle, such as through a groove.

[00127] In some examples, the diameter of the scleral tunnel needle is

substantially similar to or larger than that of the flexible member and/or haptic, thereby allowing the flexible member and haptic to be pulled into the tissue track created when the scleral tunnel needle is passed through the sclera.

[00128] Scleral tunnel needle may be used to create an intra-scleral tissue track, into which the flexible member and the haptic are drawn

[00129] In some examples, the optic element of the intraocular lens is comprised of a transparent, refractive material. In some examples, the function of the optic element is to focus light on the retina.

[00130] The following is one, non-limiting, example of a method of the present disclosure.

[00131] 1.) There are variations in the techniques which can be used to insert the intraocular lens fixation device.

[00132] 2.) A pars plana vitrectomy may be performed prior to fixation of the intraocular lens fixation device. This may include removal of a dislocated/subluxed intraocular lens or crystalline lens.

[00133] 3.) Two sclerostomies are made a short distance from the corneal limbus, approximately opposite each other. (These may be in addition to sclerostomies used for a pars plana vitrectomy). The sclerostomies may be made with a trochar and cannula system, with the cannulae left in situ.

[00134] 4.) An incision/section at or near the corneal limbus is required to insert the intraocular lens fixation device. (A dislocated/subluxed intraocular lens may be removed through the same incision if necessary).

[00135] 5.) In one example, the intraocular lens fixation device is used with a lens injector. The device is either loaded or advanced such that the flexible member protrudes in front of the tip of the injector

[00136] a) the flexible member may then be grasped with a vitreoretinal forceps and introduced through the main peri-limbal incision into the eye. Another vitreoretinal forceps is introduced through the sclerostomy (noted in point 3) further from the incision. This second forceps is used to grasp the flexible member, after which it is released by the first forceps. The flexible member is then pulled out of the eye through the sclerostomy (this will be through the cannula if one is used)

[00137] b) alternatively, the flexible member may be introduced into the eye via the peri-limbal incision with an instrument and then released, or pushed into the eye via the incision with the injector. A vitreoretinal forceps is then inserted through the sclerostomy as in 5a above to pull the flexible member out of the eye

[00138] 6.) If cannulae are used, the cannula may be withdrawn over the flexible member

[00139] 7.) The intraocular lens fixation device is injected via the peri-limbal incision. As the injector is withdrawn, the trailing flexible member, with or without part of the trailing haptic, is left exiting the peri-limbal incision.

[00140] 8.) An instrument is used to push the trailing haptic in through the peri- limbal incision and deep to the iris. The flexible member remains exiting through the incision.

[00141] 9.) The trailing flexible member can now be grasped with a vitreoretinal forceps or other instrument and pushed in through the peri-limbal incision into the eye and held in a position deep to the iris. A vitreoretinal forceps is then introduced through the other sclerostomy noted in (3). The flexible member is then grasped with this forceps, is released by the other instrument, and is pulled out through the sclerostomy.

[00142] 10.) If cannulae are used, the cannula is withdrawn over the flexible member

[00143] 1 1.) The end of the leading flexible member is now attached to the scleral tunnel needle.

[00144] 12.) The scleral tunnel needle is now passed into the scleral side-wall of the sclerostomy, and advanced such that it tracks for a distance intra-sclerally.

[00145] 13.) The needle then exits the sclera onto the ocular surface and is withdrawn. It remains attached to the flexible member. The conjunctiva may be displaced during this manoeuvre so that the scleral and conjunctival wounds are displaced relative to each other.

[00146] 14.) An instrument is then used to pull the flexible member, so that part of the haptic is drawn into the scleral tissue track/tunnel created by the needle.

[00147] 15.) The same sequence is then repeated for the trailing flexible member. [00148] 16.) The extent to which either/both flexible members is/are pulled is determined by the desired and resultant optic position.

[00149] 17.) The flexible members may now be cut flush with the conjunctiva. In another example, additional partial thickness passes through the sclera may be made with the scleral tunnel needles, and the flexible elements then tied.

[00150] 18.) The peri-limbal incision may be sutured if deemed necessary.

[00151] In some examples, it is also possible to insert the intraocular lens fixation device without using an injector. The procedure is similar to that described above. The leading flexible member is passed through the main peri-limbal incision and retrieved via the sclerostomy with vitreoretinal forceps. The optic element may then be folded with appropriate forceps and inserted with forceps through the perilimbal incision. The haptics may also be folded in some examples.

[00152] Figure 1 is a frontal view of an intraocular lens fixation device 100. The intraocular lens fixation device comprises an optic element 110. Attached to the optic element 110, is one or more haptics 120. Each haptic 120 has a first end and a second end. The first end of said haptic 120 is attached to said optic element 110. The second end of said haptic 120 is attached to first end of flexible member 130. Second end of flexible member 130 comprises connector member 140.

[00153] Figure 2 is a side view of an intraocular lens fixation device 100.

[00154] Figure 3 is a side view of a scleral tunnel needle 200. Scleral tunnel needle 200 comprises a sharp end 210. Optionally, scleral tunnel needle 200 comprises a flattened portion 220, for better manipulation using a needle holder (not shown). In Figure 3, scleral tunnel needle 200 has a curved shape. The attachment end of scleral tunnel needle 200, comprises an aperture configured to removably or fixedly receive connector member 140. In the example of Figure 3, this may be in the form of an aperture 230, connecting to a slot, 240 in the scleral tunnel needle shank, to form a key-hole shaped connector.

[00155] Figure 4 is a plan view of a scleral tunnel needle 200.

[00156] Figure 5 is an end view of a scleral tunnel needle connector. The shank of the needle has a slot, 240, which connects to an aperture, 230. In this example, the slot extends to the end of the needle.

[00157] Figure 6 is a front view of an eye 300 during surgical placement of the intraocular lens fixation device 100 (not shown). The eyeball, 310, includes the corneal limbus, 320, and the pupil margin, 330. The eyeball has an incision, A, - the corneal section through the cornea into the anterior chamber of the eye. Two sclerostomy incisions, B and C are made through the full thickness of the sclera into the vitreous body. For clarity, the eyelids and other anatomical features are not shown.

[00158] Figure 7 is a front view of an eye 300. An intraocular lens fixation device having two haptics is depicted. In this example, the haptic, flexible member, and connector member to first be inserted in the eye is referred to as "leading"; the haptic, flexible member, and connector member that is second to be inserted in the eye is referred to as "trailing". In this Figure, the leading connector member 140, and flexible member 130, have been inserted into the eye through the corneal section, passed from the anterior chamber through the pupil to the posterior chamber or posterior segment and have been retrieved through sclerostomy, B. This can be aided by passing the flexible member 130, or the connector member, 140 from one vitreoretinal forceps to a second. At this stage the leading haptic, optic element 110, the trailing haptic 120, the trailing flexible member, 130, and the trailing connector member, 140 remain external to the eye. In some examples they may be contained in a lens injector if one is to be used.

[00159] Figure 8 is a front view of an eye, 300. The leading flexible member 130 and connector member, 140, exit the eye through the sclerostomy B. The optic element, 110, has been folded and inserted into the eye or injected into the eye through the corneal section A. The optic element has been unfolded and positioned deep to the iris. The trailing haptic 120, flexible member 130, and connector member 140 have been pushed into the eye through the corneal section, A, and the trailing flexible member, 130, and connector member 140, have been retrieved and externalized through sclerostomy, C. The trailing flexible member may be handed between two vitreoretinal forceps during this process.

[00160] Figure 9 is a front view of an eye, 300. The leading connector member 140 has been coupled to the scleral tunnel needle connector, 230, in the scleral tunnel needle, 200. The scleral tunnel needle, 200, has been inserted into the sclera by passing it into the side wall of the sclerostomy, B. The scleral tunnel needle 200 has been passed a distance within the thickness of the sclera to form a scleral tunnel or tissue track, which exits the sclera at exit D.

[00161] Figure 10 is a front view of an eye, 300. The optic element 110 of the intraocular lens is internal to the eye. The leading flexible member 130, passes through a scleral tunnel which runs within the thickness of the sclera from B to D. The distal end of the leading flexible member 130, and the leading connector member 140, are external to the eye. [00162] Figure 1 1 is a front view of an eye, 300. At this stage, a second scleral tunnel has been made and the trailing flexible member 130, passes through a scleral tunnel from C to E.

[00163] Figure 12 is a front view of an eye, 300. Tension applied to the flexible members 130 has drawn the haptics 120 partially into the scleral tunnels between B and D, and C and E. The optic element 110 is well centered.

[00164] Figure 13 is a sagittal section of an eye, 300 in a plane through sclerostomies B and C in the same configuration as Figure 12. The intraocular lens is positioned inside the eye. The haptics, 120, enter the sclera at sclerostomies B and C. The haptics, 120, and the flexible members 130, pass through the scleral tunnels into- and out-of the plane of the figure. The distal ends of the flexible members 130 exit the eye at D and E (not shown) a distance into- and out-of the plane of the figure.

[00165] Figure 14 is a front view of an eye, 300. The haptics, 120, are partially securely located in scleral tunnels. The distal ends of the flexible members, 130, and connectors, 140, have been removed.

[00166] All publications, patents and patent applications mentioned in this Specification are indicative of the level of skill those skilled in the art to which this invention pertains and are herein incorporated by reference to the same extent as if each individual publication patent, or patent application was specifically and individually indicated to be incorporated by reference.

[00167] The invention being thus described, it will be obvious that the same may be varied in many ways. Such variations are not to be regarded as a departure from the spirit and scope of the invention, and all such modification as would be obvious to one skilled in the art are intended to be included within the scope of the following claims.

Claims

WHAT IS CLAIMED IS:

1. An intraocular lens fixation device, comprising:

an intraocular lens comprising an optic element;

at least two haptics attached to said optic element, each said haptic comprising a first end and a second end, each said first end of said haptic attached to said optic element; and

a flexible member having a first end and a second end,

said first end of said flexible member is attached to said second end of said haptic,

the second end of said flexible member comprising a connector member.

2. An intraocular lens fixation device, comprising:

at least two haptics, each said haptic comprising a first end and a second end; and

a flexible member having a first end and a second end,

the second end of said flexible member comprising a connector member.

3. The intraocular lens fixation device of claim 2, further comprising an intraocular lens comprising an optic element, each said first end of said haptic attached to said optic element

4. The intraocular lens fixation device according to any one of claims 1 to 3, wherein said flexible member is fixedly attached to said haptic.

5. The intraocular lens fixation device according to any one of claims 1 to 4, wherein said flexible member comprises thread, preferably surgical thread.

6. The intraocular lens fixation device according to any one of claims 1 to 5, wherein said flexible member comprises nylon, polypropylene, silk, polyester, the like, or combinations thereof.

7. The intraocular lens fixation device according to any one of claims 1 to 6, wherein said flexible member is biodegradable or resorbable, or both biodegradable and resorbable.

8. The intraocular lens fixation device according to any one of claims 1 to 7, wherein said flexible member comprises collagen, polyglycolide, polydioxanone, polyglactin 910, or mixtures thereof.

9. The intraocular lens fixation device according to any one of claims 1 to 8, wherein said flexible member comprises indicia, preferably colour coding indicia.

10. The intraocular lens fixation device according to any one of claims 1 to 9, wherein said connector member of said flexible member is configured for attachment to a needle, preferably a tunnel needle, more preferably a scleral tunnel needle.

1 1. The intraocular lens fixation device according to any one of claims 1 to 10, wherein said optic element and said at least two haptics are made of the same material.

12. The intraocular lens fixation device according to any 1 of claims 1 to 1 1 , wherein said optic element and said at least two haptics are made of optically transmissive material.

13. An intraocular lens fixation system, comprising:

an intraocular lens fixation device according to any one of claims 1 to 12, and a scleral tunnel needle.

14. A kit, comprising:

an intraocular lens fixation device according to any one of claims 1 to 12, and instructions for use.

15. The kit of claim 14, further comprising a scleral tunnel needle.

16. A kit comprising:

an intraocular lens fixation device according to any claims 1 to 12, and a scleral tunnel needle,

and optionally instructions for use.

17. A method of manufacturing an intraocular lens fixation device, comprising:

attaching a first end of flexible member to the second end of a haptic attached to an optic element.

18. The method of claim 16, wherein a second end of said flexible member comprises a connector.

19. The method of claim 17 or 18, wherein said attaching is effected using a glue.

20. The method of claim 17, 18, or 19, wherein said flexible member comprises thread, preferably surgical thread.

21 The method of any one of claims 17 to 20, wherein said flexible member comprises nylon, polypropylene, silk, polyester, the like, or combinations thereof.

22. The method of any one of claims 17 to 21 , wherein said flexible member comprises indicia, preferably colour coding indicia.

23. The method of any one of claims 17 to 22, wherein said flexible member is biodegradable or bioabsorbable, or biodegradable and bioabsorbable.

24. The method of any one of claims 17 to 23, wherein said connector member of said flexible member is configured for attachment to a needle, preferably a tunnel needle, more preferably a scleral tunnel needle.

25. An intraocular lens fixation device made according to a method of any one of claims 17 to 24.

26. Use of a fixation device according to any one of claims 1 to 12, for implanting an intraocular lens in the eye of a subject, preferably the subject is an animal, preferably the subject is a mammal, more preferably the subject is a human.

27. A method of implanting an intraocular lens into an eye of a subject, comprising: placing an intraocular lens fixation device according to any one of claims 1 to 17 in the eye of said subject,

securing the second end of each said haptic of said fixation device within a scleral tunnel in the eye of said subject.

28. The method of claim 27, wherein said scleral tunnel is produced by passing a scleral tunnel needle through the sclera of said eye, said scleral tunnel needle has a first pointed end and a second attachment end, and the connector member of said fixation device is removably or fixedly attached to said second attachment end.