WO2018172897A1

WO2018172897A1 - Ophthalmic instrument for securing an intraocular lens implant

Info

Publication number: WO2018172897A1
Application number: PCT/IB2018/051789
Authority: WO
Inventors: Guy KLEINMANN; Eliahu Eliachar
Original assignee: Mor Research Applications Ltd.
Priority date: 2017-03-19
Filing date: 2018-03-18
Publication date: 2018-09-27

Abstract

An ophthalmic surgical instrument for securing an intraocular lens (IOL) implanted within an eye, the instrument comprising: an elongated handle; a first arm, fixedly disposed at a distal end of the handle; and a second arm, pivotably disposed at a distal end of the handle; wherein the distal end of the instrument is configured to be inserted into a corneal incision of the eye and aligned such that an IOL haptic of the IOL, and the iris of the eye, are positioned between the first arm and the second arm, and wherein the second arm is configured to pivot about a transverse axis of the instrument to clasp the IOL haptic and the iris against the first arm, so as to allow the deployment of a fastener to fasten the clasped IOL haptic to the clasped iris.

Description

OPHTHALMIC INSTRUMENT FOR SECURING AN INTRAOCULAR LENS

IMPLANT

FIELD OF THE INVENTION

[1] The present invention relates to ophthalmology in general, and to medical devices utilized in cataract surgeries in particular.

BACKGROUND

[2] A cataract is the clouding of a naturally clear lens of an eye, which inhibits eyesight by causing blurry or glared vision. Cataracts commonly develop due to aging, but may also be present at birth or result from an eye injury.

[3] Cataract surgery involves the replacement of the natural eye lens with an artificial intraocular lens (10 L). The first step in the surgery is forming a small incision in the cornea, allowing access to the interior of the eye. Subsequently, the original clouded lens is broken up, emulsified or fragmented, allowing for removal of the lens through the small incision. There are a variety of techniques used for fragmentation of the original lens, such as mechanically with a fine instrument or by applying high-frequency ultrasound waves using a handheld ultrasonic device (known as "phacoemulsification"). Following the removal of the clouded eye lens, the new lens (i.e., the IOL) is implanted within the lens capsule, which is the thin clear membrane that surrounds the original lens.

[4] A typical IOL consists of a clear optical lens and lens haptic stabilizing arms protruding outwards from the optical component. The IOL is typically in a folded configuration when inserted into the eye. After the insertion, the lens unfolds and the lens haptics conforms to a desired shape in order to secure the implanted IOL.

[5] The ophthalmologist generally attempts to maintain the integrity of the lens capsule during the cataract surgery, in order to allow the IOL to be implanted into the capsular bag that remains after the extraction of the cataract lens. However, in some cases the capsular bag is ruptured, damaged or destabilized during the surgical process, preventing the IOL implant from being held in place. The lens is normally suspended by zonular fibers or "zonules", which attach the lens to the surrounding ciliary body behind the iris. These zonules may become weakened or loosened as a result of ocular trauma or surgical mishaps, which can preclude lens implantation within the lens capsule. A common cause of zonule weakening is pseudoexfoliation syndrome (PEX), characterized by the accumulation of microscopic granular protein flakes within the eye. Deficiencies in the capsular bag or supporting lens zonules can also result in dislocation of the IOL implant, which would effectively lead to deteriorated vision even after the cataract surgery. For example, a defect or tear may form in the capsular bag which can cause the lens to slip out. Alternatively, the IOL implant may remain in the capsular bag that itself destabilizes or shifts positions resulting in dislocation of the IOL contained within. An IOL is generally designed to provide enhanced vision only when implanted into a stable lens capsule.

[6] The foregoing examples of the related art and limitations related therewith are intended to be illustrative and not exclusive. Other limitations of the related art will become apparent to those of skill in the art upon a reading of the specification and a study of the figures.

SUMMARY

[7] The following embodiments and aspects thereof are described and illustrated in conjunction with systems, tools and methods which are meant to be exemplary and illustrative, not limiting in scope.

[8] In accordance with one aspect, there is thus provided an ophthalmic surgical instrument for securing an intraocular lens (IOL) implanted within an eye. The ophthalmic instrument includes an elongated handle, a first arm, and a second arm. The first arm is fixedly disposed at a distal end of the handle. The second arm is pivotably disposed at a distal end of the handle. The distal end of the ophthalmic surgical instrument is configured to be inserted into a corneal incision of the eye and aligned such that the IOL haptic and the iris of the eye are positioned between the first arm and the second arm. The second arm is configured to pivot about a substantially transverse axis of the instrument (i.e., perpendicular to a longitudinal axis of the instrument) to clasp the IOL haptic and the iris against the first arm, so as to allow the deployment of a fastener to fasten the clasped IOL haptic to the clasped iris. The first arm of the ophthalmic surgical instrument may include an interior channel terminating at an arcuate path. Additionally, an edge surface of the second arm may include a concave indentation, such that the fastener may be bent or contorted to form a curved (such as circular) shape when traversing through the channel and along the arcuate path, and the concave indentation.

[9] In accordance with another aspect of the present invention, there is provided a method for securing an IOL implanted within an eye using an ophthalmic surgical instrument. The method includes the procedures of inserting the distal end of the ophthalmic surgical instrument into a corneal incision of the eye by manipulation of an elongated handle of the ophthalmic surgical instrument. Next, aligning the instrument such that the IOL haptic and the iris are positioned between the first arm and the second arm of the instrument. The method further includes the procedures of pivoting the second arm about a substantially transverse axis of the instrument to clasp the IOL haptic and the iris against the first arm. The method further includes the procedure of deploying a fastener to fasten the clasped IOL haptic to the clasped iris.

[10] In accordance with an additional aspect of the present invention, there is thus provided an ophthalmic surgical instrument for securing an IOL implanted within an eye. The instrument includes an elongated handle and a first arm. The first arm is fixedly located at the distal end of the handle. The first arm includes a fastener. The distal end of the instrument is configured to be inserted into a corneal incision and aligned such that an IOL haptic of the IOL and the iris of the eye, are positioned between the first arm and an elongated tool inserted into the eye and minimally supporting the IOL haptic, so as to allow the deployment of the fastener to fasten the IOL haptic to the iris. Additionally, the first arm may further include an interior channel terminating at an arcuate path, such that the fastener is contorted to form a curved (such as circular) shape when traversing through the channel and along the arcuate path.

[11] In accordance with an additional aspect of the invention, there is provided a method for securing an IOL implanted within an eye using an ophthalmic surgical instrument. First, inserting a distal end of an ophthalmic surgical instrument into a corneal incision of the eye, where the ophthalmic surgical instrument. Next, the instrument is aligned such that the IOL haptic and the iris are positioned between the first arm and an elongated tool inserted into the eye. Subsequently, a fastener is deployed from the first arm to secure the IOL haptic to the iris.

[12] In addition to the exemplary aspects and embodiments described above, further aspects and embodiments will become apparent by reference to the figures and by study of the following detailed description.

BRIEF DESCRIPTION OF THE FIGURES

[13] Exemplary embodiments are illustrated in referenced figures. Dimensions of components and features shown in the figures are generally chosen for convenience and clarity of presentation and are not necessarily shown to scale. The figures are listed below. [14] Figure 1 is a side view schematic illustration of an ophthalmic instrument for securing an intraocular lens (IOL) implanted within an eye, constructed and operative in accordance with an embodiment of the present invention;

[15] Figures 2A-C are side views cutaway schematic illustrations of steps of securing an intraocular lens to an iris using the ophthalmic instrument of Figure 1;

[16] Figure 3 is an orthographic, partial cross sectional side view schematic illustration of an ophthalmic instrument for securing an IOL implanted within an eye, constructed and operative in accordance with another embodiment of the present invention.

[17] Figure 4 is a side view cutaway schematic illustration of an ophthalmic instrument of Figure 3 inserted into an eye;

[18] Figure 5A is a side view, cutaway schematic illustration ophthalmic instrument of Figure 3 with the IOL haptic and the iris positioned between a first arm and a second arm;

[19] Figure 5B is a side view, cutaway schematic illustration of ophthalmic instrument of Figure 3 deploying a fastener through the iris;

[20] Figure 5C is a side view, cutaway schematic illustration of ophthalmic instrument of Figure 3 with the fastener fully securing the IOL haptic and the iris;

[21] Figure 6, is a side view, cutaway schematic illustration of a cataract surgical operation of an eye using an ophthalmic instrument, constructed and operative in accordance with an additional embodiment of the present invention;

[22] Figure 7 A is a side view, cutaway schematic illustration of the IOL haptic and the iris positioned between the arms of ophthalmic instrument of Fig. 6;

[23] Figure 7B is a side view, cutaway schematic illustration of the ophthalmic instrument of Fig. 6 deploying the fastener through the iris;

[24] Figure 7C is a side view, cutaway schematic illustration of the fastener contorted around the IOL haptic;

[25] Figure 7D is a side view, cutaway schematic illustration of the ophthalmic instrument of Figure 6 fully securing the IOL haptic and the iris with the fastener;

[26] Figures 8A-8L are side view, cutaway schematic illustrations of different stages of deploying a sleeve and a fastener from an ophthalmic instrument, which is a variation of the ophthalmic instrument of Figure 6;

[27] Figure 9A is a schematic illustration of a rectangular fastener, constructed and operative in accordance with an embodiment of the present invention;

[28] Figure 9B is a schematic illustration of a hook fastener, constructed and operative in accordance with another embodiment of the present invention; [29] Figure 9C is a side view, cutaway schematic illustration of the hook fastener of Figure 9B fully securing the IOL haptic and the iris;

[30] Figure 9D is a side view, cutaway schematic illustration of a variation of the hook fastener of Figure 9B fully securing the IOL haptic and the iris;

[31] Figure 9E is a schematic illustration of a clamping butterfly fastener, constructed and operative in accordance with a further embodiment of the present invention;

[32] Figure 9F is a side view, cutaway schematic illustration of the clamping butterfly fastener of Figure 9E fully securing the IOL haptic and the iris; and

[33] Figure 10 is a flow chart of a method for securing an IOL implanted within an eye, operative in accordance with an embodiment of the present invention.

DETAILED DESCRIPTION

[34] Disclosed herein is an ophthalmic instrument for securing an intraocular lens (IOL) implanted within an eye. The ophthalmic instrument includes at least one arm which may be manipulated by a handle to deploy a fastener securing an IOL haptic to the iris. In a non-limiting example, the ophthalmic instrument may be used for securing an IOL implanted within an eye, such as when the lens capsule or capsular bag is damaged, destabilized or removed during a cataract surgery, precluding the implanted IOL from being held in place in the capsular bag.

[35] The terms "proximal", "distal", "upper", "lower", "inner", "outer", and other relative directional terms are used purely as exemplary relative directions in the context of the following description, and should not be construed as limiting.

[36] Reference is now made to Figure 1, which is a side view schematic illustration of an ophthalmic instrument, generally referenced 100, for securing an IOL implanted within an eye, constructed and operative in accordance with an embodiment of the present invention. Instrument 100 includes a handle 102, a first arm 104, a second arm 108 and a fastener 110. Instrument 100 is configured so that by suitable manipulation of handle 102, fastener 110 is expelled from second arm 108. Second arm 108 is designed to selectively deploy fastener 110, which may be expelled from an opening (not shown) in the wall of second arm 108.

[37] In some embodiments, handle 102 may be held and manipulated by an operator's hand. In such embodiments, handle 102 may be an elongated rod which allows an operator of surgical instrument 100 to comfortably hold and manipulate instrument 100 by grasping the proximal end of handle 102. Handle 102 may include a hand grip or a rubber coating to facilitate manual grasping and maneuvering by the operator. Additionally or alternatively, instrument 100 may be mechanically held and/or operated, e.g., for allowing remote operation of instrument 100.

[38] First arm 104 and second arm 108 are each situated on the distal end of handle 102. Optionally, first arm 104 and second arm 108 are sized and shaped to fit simultaneously into a corneal incision of the eye. First arm 104 may be a stationary extension of a lower portion of handle 102, such that the manipulation of first arm 104 is integral with the manipulation of handle 102. Optionally, first arm 104 may form an angle relative to handle 102. Alternatively, first arm 104 may be controllably pivotable into various positions and selectively secured in a desired fixed position relative to handle 102 for deployment of fastener 110. Second arm 108 is pivotally attached to the upper portion of handle 102. Second arm 108 is pivotable about a transverse axis 115 of instrument 100. Second arm 108 pivots such that one or more external objects or elements are positioned between second arm 108 and first arm 104. Optionally, second arm 108 may be designed to clasp one or more external objects or elements against first arm 104.

[39] Optionally, instrument 100 further includes a securing arm 106. Securing arm 106 may be pivotally attached to the upper portion of the distal end of handle 102 between second arm 108 and first arm 104. For example, securing arm 106 may be pivotable about transverse axis 115 (i.e., the same rotational axis as second arm 108). Securing arm 106 may be designed to clasp one or more external objects or elements, such haptic 150 and iris 152, against first arm 104, when securing arm 106 pivots such that the external elements are positioned between securing arm 106 and first arm 104 while fastener 110 is deployed.

[40] It is noted that first arm 104 and second arm 108 and/or securing arm 106 may apply only a minimal amount of pressure when clasping the external elements.

[41] Fastener 110 may be embodied by any element or mechanism designed to mechanically join or fasten together multiple external elements. For example, fastener 110 may be shaped in a manner resembling a "staple" with a bridge and at least one securing leg, where the securing leg of fastener 110 is designed to be driven through the external elements to be fastened (e.g., haptic 150 and iris 152). Once driven through the external elements, fastener 110 may be designed to fully or partially contort upon contact with first arm 104, thereby securely joining the fastened elements to one another. Alternatively, fastener 110 may be designed to bend or contort automatically, rather than contorting only upon contact with first arm 104, providing for fastening during the deployment of fastener 110. For example, fastener 110 may be composed of a shape-memory material, such as a nickel titanium alloy (Nitinol) or a shape-memory polymer (SMP). A shape-memory material is a type of "smart material" in which the physical shape of the material is altered in a controlled manner upon an external trigger. Specifically, an object formed from a shape-memory material can return from a temporary deformed (also "biased") shape to an original shape when an external trigger condition is met. For example, if the two connected legs of fastener 110 are composed of a shape-memory material, the legs may be temporarily deformed in a straight formation (as illustrated in Fig. 1) in order to facilitate driving fastener 110 through the external elements to be fastened. Upon encountering an external trigger, such as a characteristic change in temperature or the cessation of external force, the fastener legs will return to the original, inwardly collapsed position, thereby providing firm and secure fastening of the external elements.

[42] The operation of ophthalmic instrument 100 (Figure 1), will now be further described in the context of a surgical procedure for securing an IOL haptic to an iris of an eye. In a non-limiting example, the surgical procedure for securing an IOL haptic to an iris of an eye is performed during or following a cataract surgery operation. The term "cataract surgery operation" as used herein refers to a comprehensive medical procedure that involves multiple stages of the cataract treatment, including at least the removal of the natural lens, and optionally the implantation of the artificial lens. It is appreciated that the ophthalmic instrument of the present invention is described herein in relation to an ophthalmic surgical process in which an IOL haptic is to be securely fastened to an iris of an eye, but may more generally be applied to any type of surgical procedure requiring the fastening together of two or more external elements.

[43] Reference is now made to Figures 2A-C, which are side views cutaway schematic illustrations of different stages for securing an IOL haptic to an iris of an eye 140, using ophthalmic instrument 100 (Fig. 1). Eye 140 includes an iris 152 and a cornea 154. In a non-limiting example, eye 140 represents an eye where the capsular bag has been destroyed, damaged or removed during a cataract surgery, such as during the fragmentation of the original eye lens. An IOL, referenced 148, is a transparent lens intended to be a replacement for a natural eye lens. IOL 148 includes a plurality of IOL haptics 150 protruding outwards from the body of the lens, and which acts as stabilizing arms for IOL 148. Typically, the steps for securing an IOL haptic to an iris follow a preliminary step of introducing IOL 148 into an eye such that IOL is positioned proximally to iris 152 and IOL haptic 150 is positioned distally to iris 152. IOL 148 as used herein may be more broadly encompassed by any type or form of an artificial lens and IOL haptic 150 as any form of stabilizing membranes that protrude from the artificial lens.

[44] Referring to Fig. 2A, following insertion of IOL 148, first arm 104 is positioned distally to IOL haptic 150 and securing arm 106 is positioned proximally to iris 152, such that IOL haptic 150 and iris 152 are positioned between first arm 104 and securing arm 106. Optionally, instrument 100 is manipulated via handle 102 to insert the distal end of handle 102 into the corneal incision.

[45] Referring to Fig. 2B, following pivoting of securing arm 106 towards first arm 104 about transverse axis 115, IOL haptic 150 and iris 152 are clasped against first arm 104.

[46] Referring to Fig. 2C, fastener 110 is deployed following pivoting of second arm 108 toward securing arm 106 The deployed fastener 110 passes through iris 152 and encircles IOL haptic 150, securely affixing IOL haptic 150 to iris 152. The legs of fastener 110 may collapse or fold upon deployment in order to secure IOL haptic 150 with iris 152.

[47] Optionally, any of the steps illustrated in Figs. 2A-C may be repeated to securely affix additional haptics 150 of IOL 148 to iris 152. In particular, an operator may maneuver instrument 100 to position a second IOL haptic 150 of IOL 148, and another portion of iris 152 between first arm 104 and securing arm 106. The operator then activates the pivoting of securing arm 106 to securely clasp the second IOL haptic 150 and the portion of iris 152 against first arm 104. Subsequently, the operator activates second arm 108 to pivot toward second arm 106 and deploy another fastener 110, securely affixing the second IOL haptic 150 to another portion of iris 152. After all required IOL haptics 150 are secured, IOL 148 is held in place at a suitable position within eye 140 even when eye 140 is lacking a stable lens capsule or capsular bag. In some embodiments, following the securing of haptics 150, the IOL is moved to a suitable position within eye 140. In a non- limiting example, the suitable position is posterior to the iris 152. Alternatively, the suitable position is anterior to the iris 152.

[48] Reference is now made to Figure 3, which is an isometric view schematic illustration of an ophthalmic instrument, generally referenced 200, for securing an artificial lens implanted within an eye, constructed and operative in accordance with another embodiment of the present invention. Instrument 200 includes a handle 202, a first arm 204, a second arm 208 and a fastener 224. First arm 204 includes a concave indentation 207 configured to receive an external element, such as IOL haptic 150, such that haptic 150 is securely engaged within the concave indentation 207. First arm 204 includes fastener 224 and a push rod 226. First arm 204 further includes an interior channel 222 terminating at an arcuate path 225. Channel 222 is configured to accommodate fastener 224 and push rod 226. Second arm 208 is pivotable about a transverse axis 215 of instrument 200. Second arm 208 includes a concave indentation 227, aligned opposite to, and slightly larger than, the concave indentation 207 of first arm 204. Together, arcuate path 225 and concave indentation 227 form a circular channel able to accommodate fastener 224. Channel 222, fastener 224, and push rod 226 may alternatively be situated in second arm 208 or handle 202. Fastener 224 is a flexible or rigid rod, elastic or plastically deformable (respectively), designed to mechanically join two or more external elements. Fastener 224 is comprised of a leading piercing end 231 and a trailing end 233. Leading piercing end 231 may be sharp or blunt, but may either way enable penetration through an external object. Additionally, trailing end 233 may be designed to join with leading piercing end 231 such that fastener 224 forms a closed loop, limiting damage or discomfort from an exposed tip of fastener 224. For example, leading piercing end 231 may be sufficiently sharp such that leading piercing end 231 affixes to trailing end 233 upon contact. Alternatively, trailing end 233 may include an aperture configured to engage with piercing end 231, such that leading piercing end 231 enters the aperture and presses its walls radially, forming a tight attachment. Further alternatively, trailing end 233 and leading piercing end 231 become parallel along a certain portion of their length when fastener 224 forms a closed loop.

[49] Push rod 226 is a cylindrical rod, whose dimensions substantially conform to those of trailing end 233. Fastener 224 and push rod 226 are longitudinally displaceable along interior channel 222. Fastener 224 is located on the distal end of interior channel 222, proximate to arcuate path 225. Push rod 226 is located on the proximal side of interior channel 222, proximate to fastener 224. Push rod 226 impels fastener 224 through interior channel 222, around arcuate path 225, and around concave indention 227 such that fastener 224 punctures the element(s) that are clasped between first arm 204 and second arm 208. As mentioned, fastener 110 of instrument 100 (Fig. 1) may be composed of a shape-memory material, such that when fastener 110 encounters an external trigger condition, the legs of fastener 110 contort into a collapsed position to facilitate securely fastening the elements to be fastened. Optionally, fastener 224 of instrument 200 (Fig. 3) may be composed of a material such as a plastic or a metal which is not superelastic, as opposed to a shape-memory material, since fastener 224 is contorted and plastically deformed by arcuate path 225 and concave indention 227. In particular, push rod 226 may impel fastener 224 through channel 222 along arcuate path 225 and concave indention 227 into a suitable position to facilitate secure fastening without requiring an external trigger condition. In a non-limiting example, fastener 224 is contorted into a curved (such as circular) shape.

[50] Ophthalmic instrument 100 and 200 may optionally include and/or be associated with additional components not shown in Fig. 1 and Fig. 3, for enabling the implementation of the disclosed subject matter. For example, ophthalmic instrument (100, 200) may also include a motor or other electro-mechanical rotational mechanism (not shown) for effecting the rotation of second arm (108, 208) or securing arm 106, as well as a power supply, such as batteries, for providing power to such a rotational mechanism. Ophthalmic instrument (100, 200) may also include a button, a switch, a lever, or an alternative control mechanism (not shown), such as for activating the rotation of second arm (108, 208) and/or securing arm 106. For example, the control mechanism may be situated on handle (102, 202), providing ease of access to the operator. Ophthalmic instrument (100, 200) may further include a user interface (not shown) for providing visual and/or auditory feedback, such as to provide an indication of current operational modes or settings associated with ophthalmic instrument (e.g., the relative positions of each of arms (104, 204), (108, 208), and 106).

[51] Reference is now made to Figure 4, which is a side view cutaway schematic illustration of a stage for securing an IOL haptic to an iris of an eye 140, using ophthalmic instrument 200 of Fig. 3. Eye 140 includes an iris 152 and a cornea 154. Eye 140 represents an eye where the capsular bag has been destroyed, damaged or removed during the course of a cataract surgery. Following introduction of IOL 148, the instrument 200 is positioned such that IOL haptic 150 and iris 152 are positioned between first arm 204 and second arm 208. The pivoting of second arm 208 may be activated to clasp IOL haptic 150 and iris 152 against first arm 204. Sequentially, fastener 224 may be deployed.

[52] Reference is made to Figures 5A to 5C, detailing the deployment of fastener 224 from instrument 200. Figure 5A is a side view, cutaway schematic illustration ophthalmic instrument 200 with IOL haptic 150 and iris 152 positioned between first arm 204 and second arm 208. Figure 5B is a side view, cutaway schematic illustration of ophthalmic instrument 200 deploying fastener 224 through iris 152. Figure 5C is a side view, cutaway schematic illustration of ophthalmic instrument 200 with fastener 224 fully securing IOL haptic 150 and iris 152. First, ophthalmic instrument 200 is positioned such that IOL haptic 150 and iris 152 are between first arm 204 and second arm 208 (Fig. 5A). Subsequently, fastener 224 is deployed. In particular, push rod 226 impels fastener 224 through channel 222, deploying leading piercing end 231 around arcuate path 225 such that leading piercing end 231 is contorted around arcuate path 225 to pierce through a first portion of iris 152. After piercing through the first portion of iris 152, leading piercing end 231 is contorted around concave indentation 227 (Fig. 5B) piercing through a second part of iris 152. Finally, push rod 226 impels fastener 224 such that leading piercing end 231 is contorted around arcuate path 225 and leading piercing end 231 joins with trailing end 233 (Fig. 5C).

[53] Reference is now made to Figure 6, which is a side view cutaway schematic illustration of a cataract surgical operation of eye 140 using an ophthalmic instrument, generally referenced 275, constructed and operative in accordance with an additional embodiment of the present invention. Instrument 275 includes a handle portion 276, a first arm 278, an optional elongated tool such as a spatula 280, and a fastener 224. First arm 278 is situated on the distal end of handle 276 and is sized and shaped to fit into a corneal incision of the eye. First arm 278 may be attached to handle 276 such that the manipulation of first arm 278 is integral with the manipulation of handle 276.

[54] Referring to Fig. 7A, first arm 278 includes fastener 224, an interior channel 281, and a concave indentation 283. Interior channel 281 and concave indentation 283 are configured to accommodate fastener 224. Spatula 280 is optional and can be embodied as any tool or instrument that can fit through the incision in the eye. Spatula 280 is designed to contact and support IOL haptic 150 against iris 152. Alternatively, spatula 280 may be inserted into the eye such that it supports only the optic of IOL 148 and not the haptic 150 (this alternative is not shown). Spatula 280 may provide minimal support or a stable surface allowing fastener 224 to fasten IOL haptic 150 with iris 152 when deployed from first arm 278. In addition, the force applied by spatula 280 on IOL haptic 150 (or optic) pressing against iris 152 may form a temporary indentation on iris 152 viewable by the operator. By viewing the indentation (not shown in Fig. 6), the operator may obtain a visual indication of the precise location of IOL haptic 150 and iris 152, allowing the operator to precisely align first arm 278 with respect to spatula 180 so that the fastener will secure both IOL haptic 150 and iris 152.

[55] Probe 280 is inserted through a corneal incision independent from first arm 278. Probe 280 may be inserted through either the same or a different corneal incision as first arm 278. Since probe 280 is not attached to handle 276, instrument 275 is able to fit through a smaller corneal incision than instrument 200 (Fig. 3). In general, any of the arms of an instrument of the present invention may be embodied by a separate element detached from the main instrument (e.g., a stand-alone tool or spatula).

[56] Reference is made to Figures 7 A to 7D, detailing the deployment of a fastener from instrument 275. Figure 7 A is a side view, cutaway schematic illustration of IOL haptic 150 and iris 152 positioned between the arms of ophthalmic instrument 275. Figure 7B is a side view, cutaway schematic illustration of ophthalmic instrument 275 deploying fastener 224 through iris 152. Figure 7C is a side view, cutaway schematic illustration of fastener contorted around IOL haptic 150. Figure 7D is a side view, cutaway schematic illustration of ophthalmic instrument 275 fully securing IOL haptic 150 and iris 152 with fastener 224. Initially, what is known as an "optic capture" is formed, wherein IOL 148 is positioned with its IOL haptics 150 posteriorly to the iris, while its optic is positioned anteriorly to the iris. Then, probe 280 is inserted through a corneal incision. Probe 280 is aligned and is pressed against IOL haptic 150 which subsequently presses against iris 152 causing a temporary indentation and raised portion on iris 152, referenced 292. Using the iris indentation 292, the operator of instrument 275 positions instrument 275 such that first arm 278 is aligned to enable fastening of IOL haptic 150 and iris 152 when fastener 224 is deployed. The operator deploys fastener 224, resulting in fastener 224 being displaced along channel 281 around concave indentation 283 (Fig. 7A). Leading piercing end 231 consequently pierces through iris 152 (Fig. 7B). After piercing through iris 152, fastener 224 contorts around IOL haptic 150 and towards first arm 278 (Fig. 7C). Probe 280 may contort fastener 224 upon contact with fastener 224. Finally, leading piercing end 231 pierces through another point on iris 152, and leading piercing end 231 joins with trailing end 233 to secure IOL haptic 150 and iris 152 together (Fig. 7D).

[57] Reference is made to Figures 8A to 8L, detailing the deployment of a fastener from instrument 375. Instrument 375 is substantially similar to instrument 275 described in Figure 6 and 7A-D, with the notable difference that a fastener 324 is housed within a sleeve 323. Instrument 375 includes a handle portion (not shown), a first arm 378, and an optional spatula 380. First arm 378 is situated on the distal end of the handle and is sized and shaped to fit into a corneal incision of the eye. First arm 378 is attached to the handle (not shown) such that the manipulation of first arm 378 is integral with the manipulation of the handle. First arm 378 includes sleeve 323 which houses fastener 324, an interior channel 381, and a concave indentation 383. Interior channel 381 and concave indentation 383 are configured to accommodate sleeve 323. [58] Figure 8A is a side view, cutaway schematic illustration of IOL haptic 150 and iris 152 positioned between the arms of ophthalmic instrument 375.

[59] Figure 8B is a side view, cutaway schematic illustration of ophthalmic instrument 375 deploying sleeve 323 through iris 152.

[60] Figure 8C is a side view, cutaway schematic illustration of sleeve 323 contorted around IOL haptic 150.

[61] Figure 8D is a side view, cutaway schematic illustration of ophthalmic instrument 375 fully securing IOL haptic 150 and iris 152 with sleeve 323.

[62] Figure 8E is a side partially transparent view, cutaway schematic illustration showing fastener 324 housed within sleeve 323 which secures IOL haptic 150 and iris 152.

[63] Figure 8F is a side partially transparent view, cutaway schematic illustration showing advancement of fastener 324 within sleeve 323 which secures IOL haptic 150 and iris 152.

[64] Figure 8G is a side partially transparent view, cutaway schematic illustration showing fastener 324 within sleeve 323 contorted around IOL haptic 150.

[65] Figure 8H is a side partially transparent view, cutaway schematic illustration showing fastener 324 within sleeve 323 contorted around IOL haptic 150.

[66] Figure 81 is a side partially transparent view, cutaway schematic illustration of fastener 324 within sleeve 323 fully securing IOL haptic 150 and iris 152.

[67] Figure 8J is a side view, cutaway schematic illustration of ophthalmic instrument

375, showing partial retraction of sleeve 323, exposing fastener 324.

[68] Figure 8K is a side view, cutaway schematic illustration of ophthalmic instrument

375, showing retraction of sleeve 323 from iris 152 into interior channel 381.

[69] Figure 8L is a side view, cutaway schematic illustration of ophthalmic instrument

375, showing full retraction of sleeve 323 into interior channel 381, exposing fastener 324 which fully secures IOL haptic 150 and iris 152.

[70] Initially, probe 380 is inserted through a corneal incision. Probe 380 is aligned and is pressed against IOL haptic 150 which subsequently presses against iris 152 causing a temporary indentation and raised portion on iris 152, referenced 292. Using the iris indentation 292, the operator of instrument 375 positions instrument 375 such that first arm 378 is aligned to enable fastening of IOL haptic 150 and iris 152 when sleeve 323 is deployed. The operator deploys sleeve 323, resulting in sleeve 323 being displaced along channel 281 around concave indentation 383 (Fig. 8A). Piercing end 331 consequently pierces through a first point 152a of iris 152 (Fig. 8B). After piercing through iris 152, sleeve 323 contorts around IOL haptic 150 and towards first arm 378 (Fig. 8C). Probe 380 may contort sleeve 323 upon contact with sleeve 323. Next, piercing end 331 pierces through another point 152b on iris 152 (Fig. 8D). Fastener 324 is advanced through sleeve 323 (Figs. 8E-I). Sleeve 323 is retracted through point 152b on iris 152 (Fig. 8 J) and through point 152a on iris 152 (Fig. 8K) into interior channel 381. Finally, head 331b of fastener 324 joins with trailing end 233 of fastener 324 to secure IOL haptic 150 and iris 152 together (Fig. 8L).

[71] Different types or configurations of fasteners may be used in conjunction with the ophthalmic instrument of the present invention. Reference is now made to Figure 9A, 9B, 9C, 9D, 9E, and 9F.

[72] Figure 9A is a schematic illustration of a bridge-type fastener, referenced 320, constructed and operative in accordance with an embodiment of the present invention.

[73] Figure 9B is a schematic illustration of a hook fastener, referenced 330, constructed and operative in accordance with an additional embodiment of the present invention; Figure 9C illustrates hook fastener 330 fully securing the IOL haptic and the iris. Figure 9D shows a hook fastener, referenced 330a, which is a variation of hook fastener 330 of Figures 9B and 9C. Hook fastener 330a includes multiple radial protrusions that form a unidirectional securing mechanism. These protrusions make hook fastener 330a easy to insert into the tissue, but harder to pull back - forming a type of a ratchet mechanism with the tissue.

[74] Figure 9E is a schematic illustration of a clamping butterfly fastener, referenced 340, constructed and operative in accordance with a further embodiment of the present invention; Figure 9F illustrates clamping butterfly fastener 340 fully securing the IOL haptic and the iris.

[75] Fastener 320 (Fig. 9A) is similar to fastener 110 of Figs. 1 and 2. It is a bridge-type fastener with a bridge 322 interconnecting two legs 326a-b. Bridge 322 is typically straight but may be curved or bent. Legs 326a-b are straight and are designed to collapse. Legs 326a-b are connected by crown 322 at relative proximal ends. Upon deployment of fastener 320, legs 326a-b pierce into the iris, while bridge 322 remains on an outer surface of the iris. Once through the iris and IOL haptic, legs 326a-b may collapse to securely fasten the iris and IOL haptic together. For example, referring to Figure 2A, fastener 320 is deployed from second arm 108 with legs 326a-b driving through iris 152 and IOL haptic 150. Bridge 322 remains on an outer surface of iris 152, securing IOL haptic 150 to iris 162. Legs 326a-b collapse upon contacting first arm 104 to securely fasten together iris 152 and IOL haptic 150.

[76] Fastener 330 (Figs. 9B and 9C) is a hook fastener with a flat portion 332 and a curved loop 334. Flat portion 332 is designed to be positioned onto the outer surface of the iris. Loop leg 334 is an open circular shape connected to flat portion 332. Loop leg 334 curves during driving through the iris and IOL haptic. For example, referring to Figure 2A, fastener 330 is deployed from second arm 108 with flat portion 332 on an outer surface of iris 152. Loop leg 334 curves as it drives through iris 152 and IOL haptic 150. With flat portion 332 on an outer surface of iris 152 and loop leg 334 secured through IOL haptic 150 and iris 152, IOL 148 is secured to iris 162. Unlike rectangular fastener 320, loop fastener 330 is circularly shaped and securely fastens IOL haptic 150 and iris 152 together in one step, eliminating the need for a collapsing portion of fastener 330.

[77] Fastener 340 (Figs. 9E and 9F) includes a spine 341, a piercing side 342 and an anchoring side 344. Spine 341 is a straight portion of fastener 340 connecting piercing side 342 and anchoring side 344. Spine 341 is designed to be driven through iris 152 and next to IOL haptic 150, thereby fastening IOL haptic 150 to iris 152. Piercing side 342 has two driving legs 343 which are configured to assume a collapsed or an open configuration. When piercing side 342 is in a collapsed configuration, driving legs 343 are forced against spine 341 and piercing side 342 can be driven through external elements, such as the iris. In the open configuration of piercing side 342, driving legs 343 protrude from spine 341, as seen in Figures 7E and 7F. Anchoring side 344 has two anchoring legs 345 which are designed to remain in an open configuration. In a fully open configuration, piercing side 342 and anchoring side 344 secure the iris and IOL haptic together with spine 341. For example, referring to Figure 2A, upon deployment of fastener 340 from second arm 108, driving legs 343 are collapsed against spine 341 allowing piercing side 342 and spine 341 to drive through iris 152 and IOL haptic 150. Anchoring side 344 remains in an open configuration on the outer side of iris 152. Once passed through IOL haptic 150 and iris 152, piercing side 342 deploys into an open configuration, thereby securely fastening IOL haptic 150 and iris 152 between piercing side 342 and anchoring side 344 on spine 341.

[78] Reference is now made to Figure 10, which is a flow chart of a method for securing an IOL implanted within an eye, operative in accordance with an embodiment of the present invention. In procedure 402, the distal end of an ophthalmic surgical instrument is inserted into a corneal incision of an eye. Referring to Figure 3, the operator inserts the distal end of instrument 200 into a corneal incision of eye 140 by suitable manipulation of handle 202, such that first arm 204 and second arm 208 are inserted proximate to iris 152 and IOL haptic 150.

[79] In procedure 404, the ophthalmic surgical instrument is aligned such that the IOL haptic, and the iris of the eye, are positioned between a first arm and a second arm of the instrument. Referring to Figure 3, the operator manipulates handle 202 of instrument 200, aligning instrument 200, whereas iris 152 and IOL haptic 150 are positioned between first arm 204 and second arm 208. First arm 204 is aligned to enable fastening of IOL haptic 150 and iris 152 when fastener 224 is deployed.

[80] In procedure 406, the second arm is pivoted to clasp the IOL haptic and the iris against the first arm. Referring to Figure 3, the operator keeps handle 202 stationary to maintain first arm 204 positioned proximate to IOL haptic 150. The operator additionally activates the rotation of second arm 208 (e.g., via control mechanism 204), triggering second arm 208 to pivot about transverse axis 215 toward first arm 204, clasping iris 152 and IOL haptic 150 against first arm 204. Second arm 208 provides support or a stable surface allowing fastener 224 to fasten IOL haptic 150 with iris 152 when deployed from first arm 204.

[81] In procedure 408, a fastener is deployed to secure the clasped IOL haptic to the clasped iris. Referring to Figure 3, the operator activates push rod 226 (e.g., via control mechanism 204), such that push rod 226 impels fastener 224 laterally through interior channel 222, deploying fastener 224 around arcuate path 225 and leading piercing end 231 pierces through a first portion of iris 152. As push rod 226 further impels fastener 224 around concave indentation 227 and leading piercing end 231 punctures through a different portion of iris 152. Finally, as push rod 226 impels fastener 224, leading piercing end 231 joins with trailing end 233, fastening IOL haptic 150 to iris 152. Alternatively, in reference to Figure 2B and instrument 100, second arm 108 pivots about transverse axis 115 to deploy fastener 110 through iris 152. Additionally, part of fastener 110 may collapse when contacting first arm 104, securing the fastening of IOL haptic 150 and iris 152. For example, fastener 110 may be embodied by rectangular fastener 320 with legs 326a-b (Fig. 9A). Once fastener 320 is deployed through IOL haptic 150 and iris 152, legs 326a-b collapse toward each other, securely fastening iris 152 together with IOL haptic 150.

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

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

[84] It is appreciated that certain features of the invention, which are, for clarity, described in the context of separate embodiments, may also be provided in combination in a single embodiment. Conversely, various features of the invention, which are, for brevity, described in the context of a single embodiment, may also be provided separately or in any suitable sub-combination or as suitable in any other described embodiment of the invention. Certain features described in the context of various embodiments are not to be considered essential features of those embodiments, unless the embodiment is inoperative without those elements. Aspects of the present invention are described herein with reference to flowchart illustrations and/or block diagrams of methods, and apparatus (systems) according to embodiments of the invention. It will be understood that each block of the flowchart illustrations and/or block diagrams, and combinations of blocks in the flowchart illustrations and/or block diagrams, can be implemented by computer readable program instructions.

[85] The descriptions of the various embodiments of the present invention have been presented for purposes of illustration, but are not intended to be exhaustive or limited to the embodiments disclosed. Many modifications and variations will be apparent to those of ordinary skill in the art without departing from the scope and spirit of the described embodiments. Further, the ophthalmic instrument of the invention may be utilized for additional applications. The terminology used herein was chosen to best explain the principles of the embodiments, the practical application or technical improvement over technologies found in the marketplace, or to enable others of ordinary skill in the art to understand the embodiments disclosed herein.

Claims

CLAIMS What is claimed

1. An ophthalmic surgical instrument for securing an intraocular lens (10 L) implanted within an eye, the instrument comprising:

an elongated handle;

a first arm, fixedly disposed at a distal end of the handle; and

a second arm, pivotably disposed at said distal end of the handle; wherein the distal end of the instrument is configured to be inserted into a corneal incision of the eye and aligned such that an IOL haptic of the IOL, and a portion of the iris of the eye, are positioned between the first arm and the second arm, and wherein the second arm is configured to pivot about a transverse axis of the instrument to clasp the IOL haptic and the portion of the iris against the first arm, so as to allow the deployment of a fastener to fasten the clasped IOL haptic to the clasped iris.

2. The ophthalmic surgical instrument of claim 1, wherein the first arm comprises an interior channel terminating at an arcuate path, and wherein an edge surface of the second arm comprises a concave indentation, such that the fastener is contorted to form a circular shape when traversing through the channel and along the arcuate path and the concave indentation.

3. The ophthalmic surgical instrument according to claim 2, further comprising a push rod configured to deploy the fastener through the channel and along an arcuate path and the concave indentation.

4. The ophthalmic surgical instrument according to any one of claims 1 and 2, wherein the fastener is deployed from the first arm.

5. The ophthalmic surgical instrument according to any one of claims 1 and 2, wherein the fastener is deployed from the second arm.

6. The ophthalmic surgical instrument according to any one of claims 1-3, further comprising a securing arm pivotably disposed at a distal end of the handle, wherein the fastener is deployed from the securing arm.

RECTIFIED SHEET (RULE 91 )

7. The ophthalmic surgical instrument of claim 1, wherein the fastener comprises a clamping butterfly fastener.

8. The ophthalmic surgical instrument according to any one of claims 1-7, wherein the fastener comprises a leading piercing end and a trailing end.

9. The ophthalmic surgical instrument according to claim 8, wherein the trailing end is configured to join with the leading piercing end such that fastener forms a closed loop.

10. The ophthalmic surgical instrument according to any one of claims 8 and 9, wherein the trailing end comprises an aperture configured to engage with the piercing end such that the piercing end enters the aperture and presses its walls radially, forming a tight attachment.

11. A method for securing an intraocular lens (10 L) implanted within an eye using an ophthalmic surgical instrument, the method comprising the procedures of:

inserting a distal end of the ophthalmic surgical instrument into a corneal incision of the eye;

aligning the instrument such that an IOL haptic of the IOL, and the iris of the eye, are positioned between a first arm and a second arm of the instrument;

pivoting the second arm about a transverse axis of the instrument, to clasp the IOL haptic and the iris against the first arm; and

deploying a fastener to fasten the clasped IOL haptic to the clasped iris.

12. The method according to claim 11, wherein deploying the fastener comprises

pushing a push rod; and

deploying the fastener through an interior channel in said first arm terminating at an arcuate path.

13. The method according to claim 12, wherein

inserting the fastener and traversing through a portion of the iris; and contorting the fastener into a circular shape enclosing the IOL haptic.

RECTIFIED SHEET (RULE 91 )

14. The method according to claim 13, wherein further pushing the push rod and driving a leading end of the fastener into a trailing end of the fastener and forming a closed loop.

15. An ophthalmic surgical instrument for securing an intraocular lens (10 L) implanted within an eye, the instrument comprising:

an elongated handle; and

a first arm, fixedly disposed at a distal end of the elongated handle, the first arm comprising a fastener; wherein the distal end of the instrument is configured to be inserted into a corneal incision of the eye and aligned such that an IOL haptic of the IOL, and the iris of the eye, are positioned between the first arm and an elongated tool inserted into the eye and supporting the IOL haptic, so as to allow the deployment of the fastener to fasten the IOL haptic to the iris.

16. The ophthalmic surgical instrument of claim 15, wherein the first arm further comprises an interior channel terminating at an arcuate path, such that the fastener is contorted to form a circular shape when traversing through the interior channel and along the arcuate path.

17. The ophthalmic surgical instrument according to any one of claims 15-16, further comprising a push rod configured to deploy the fastener through the interior channel and along the arcuate path.

18. The ophthalmic surgical instrument according to any one of claims 15-16, further comprising a sleeve disposed within said first arm and housing said fastener.

19. The ophthalmic surgical instrument according to any one of claims 1-11 and 15-18, wherein at least a portion of the fastener comprises a shape-memory material.

20. The ophthalmic surgical instrument according to any one of claims 1-7 and 14-18, wherein at least a portion of the fastener is configured to bend upon deployment.

21. A method for securing an intraocular lens (IOL) implanted within an eye using an ophthalmic surgical instrument, the method comprising the procedures of:

RECTIFIED SHEET (RULE 91 ) inserting a distal end of the ophthalmic surgical instrument into a corneal incision of the eye;

aligning the instrument, such that a IOL haptic of the IOL, and the iris of the eye, are positioned between a first arm at a distal end of the instrument and an elongated tool inserted into the eye; and

deploying a fastener from the first arm to fasten the IOL haptic to the iris.

22. The method according to claim 21, wherein deploying the fastener comprises

pushing a push rod; and

23. The method according to claim 21, wherein

24. The method according to claim 23, wherein further pushing the push rod and driving a leading end of the fastener into a trailing end of the fastener and forming a closed loop.

RECTIFIED SHEET (RULE 91 )