Intraocular lens (IOL) and related components and intraocular attachment methods

Abstract

Intraocular lens and related components and intraocular attachment methods are disclosed herein. In one embodiment, an intraocular lens component includes a helical coil fastener to attach an intraocular lens to an iris to correct for astigmatism, presbyopia, and / or myopia or hyperopia. The helical coil fastener includes a head and a helical wire extending from a bottom surface of the head and including a pointed tip opposite the head. The helical coil fastener is configured to be attached to the iris by being rotatably threaded into the iris, and thus can be removed from the iris by counter-rotation of the helical coil fastener. The helical coil fastener has a small volume, a large surface area, a small threading cross-sectional area, and a threading tilt angle. Thus, the helical coil fastener is easy to apply, easy to remove, minimizes tissue damage, maximizes stability, and minimizes threading force.

Description

[0001] Divisional application

[0002] This application is a sub-division of divisional application 202010075690.2. The entire contents of original application 201680055450.8 and divisional application 202010075690.2 are incorporated herein by reference.

[0003] Priority application

[0004] This application claims the benefit of priority under 35 U.S.C. 119(e) of U.S. Provisional Application Serial No. 62 / 205,226, filed August 14, 2015, entitled “Apparatus and Methods for Refractive Intraocular Implant System,” the contents of which are incorporated herein by reference in their entirety. Technical Field

[0005] The field of this disclosure generally relates to apparatus and methods for intraocular attachment systems, and more specifically to implant design, surgical methods, tools and fasteners for attaching intraocular implants to the iris. Background Technology

[0006] Patients and surgeons have long been interested in alternatives to eyeglasses that compensate for eye abnormalities. These alternatives include, for example, contact lenses, radial keratotomy, LASIK, or laser vision correction surgery. However, these alternatives are not without their drawbacks. For instance, LASIK surgery has limitations in its corrective capacity, can weaken the cornea, and may cause other complications such as fluctuating vision, halos, glare, and dry eye.

[0007] Therefore, implantable intraocular lenses (IOLs) have become an increasingly popular alternative for providing correction, especially for patients who cannot opt ​​for LASIK surgery. An IOL is a lens surgically implanted inside the eye and typically consists of the lens and one or more haptic devices for attaching and holding the lens in place. Several different types of IOLs exist, including phakic and aphakic intraocular lenses. IOLs are usually surgically positioned within the anterior chamber of the eye or between the iris and the lens, and many are attached to the angular space of the eye or the anterior surface of the iris. IOLs can be placed on and used with the eye's existing natural lens to modify the eye's optical power and performance, particularly correcting errors in the eye's focusing ability, such as presbyopia and / or myopia or hyperopia.

[0008] However, some IOLs require multiple incisions, large incisions, and / or multi-handed surgical techniques (e.g., two-handed, three-handed, or requiring multiple instrument transfers from hand to hand) to insert and attach to the iris, or require implants of special sizes (e.g., implants placed between the human lens and iris) until then or during surgery. Furthermore, the devices used to attach IOLs to the eye are often designed to ensure fixation and prevent accidental detachment; as a result, the fixation devices may cause significant tissue damage to the iris and / or be difficult to remove. This can lead to surgical or clinical failures for some IOLs, which may include problems with lens insertion and attachment, intraocular or iris hemorrhage, inflammation, endothelial cell loss, pupillary deformities, or lens-induced glaucoma. Therefore, many current IOL surgeries are difficult to insert and attach, require large incisions within the cornea for surgical access, are difficult to remove, and / or result in complications due to aggravated and damaged iris tissue and / or corneal endothelial cell loss. Summary of the Invention

[0009] The embodiments disclosed herein include intraocular lenses (IOLs) and related components, implants, and intraocular attachment methods. In some aspects, a helical coil fastener, along with associated applicator tools and surgical insertion methods, is provided to attach the IOL to the iris relative to the pupil. In one embodiment, the IOL component includes a helical coil fastener to attach the IOL to the iris to correct astigmatism, presbyopia, and / or myopia or hyperopia. An IOL can be implanted to correct visual errors while the patient's natural lens is removed or left in place. The IOL can be used as a phakic implant (e.g., for use in the presence of a lens) or as a phakic implant (e.g., for use in the absence of a lens). The IOL has optics for correcting astigmatism and / or myopia or hyperopia (e.g., a first optical effect). The IOL may also have another optical effect (e.g., a second optical effect) for addressing presbyopia (e.g., as a phakic IOL working in conjunction with a lens up to 2.0 diopters) or as a phakic IOL for addressing presbyopia (e.g., up to 4.0 diopters). The optics also have one or more tactile elements extending from their periphery, configured to facilitate attachment of the IOL to the iris relative to the pupil. The tactile elements can be arched to minimize contact with the iris while maintaining an appropriate distance from the cornea. In this regard, a helical coil fastener is provided, configured to engage the optics to attach the IOL to the iris. The helical coil fastener includes a head and a helix extending from the bottom surface of the head and including a pointed tip opposite the head. Once the IOL is positioned relative to the pupil, the helical coil fastener is configured to be applied to the distal end of each tactile element to penetrate the anterior surface of the iris at an oblique angle, thereby attaching the IOL relative to the pupil. The helical coil fastener is configured to be attached to the iris by rotatably penetrating it, and therefore can be removed from the iris by reverse rotation of the helical coil fastener. The helical coil fastener has a small volume, a large surface area, a small penetration cross-sectional area, and a penetration angle. Therefore, helical coil fasteners are easy to apply, easy to remove, minimize tissue damage, maximize stability, and minimize penetration force.

[0010] Further embodiments disclosed herein relate to other fasteners, IOLs, IOL assemblies, and methods for attaching an IOL to the iris for correction and astigmatism, with and without presbyopia vision correction. In this regard, some further embodiments provide fasteners configured to engage the optical components of the IOL to attach the IOL to the iris. These further embodiments may also have one or more features to facilitate and / or control the fastener insertion position and / or insertion depth when attaching the IOL to the iris.

[0011] In this regard, in one embodiment, an intraocular lens assembly configured to be inserted into and attached to an eye having a lens includes an intraocular lens, a tactile element, and a helical coil fastener. The intraocular lens includes an optic for producing a preselected optical effect, the optic including an outer periphery. The tactile element extends from the outer periphery of the optic and includes a proximal end, a distal end, and a raised portion therebetween. The proximal end of the tactile element is located at a different height from the distal end at the outer periphery of the optic. The helical coil fastener includes a wire with a pointed end. The helical coil fastener is configured to attach the tactile element to the eye by inserting it through the distal end of the tactile element and rotatably penetrating the anterior side of the iris to compress a portion of the tactile element between the top portion of the helical coil fastener and the anterior side of the iris.

[0012] In another embodiment, a surgical method for treating an eye disease with an intraocular lens assembly includes: creating an incision in the eye to be treated and inserting a folded intraocular lens and a tactile element through the incision into the eye. The folded intraocular lens unfolds after insertion into the eye. The intraocular lens includes an optical element for generating a preselected optical effect. The tactile element extends from the outer periphery of the optical element. The surgical method further includes: attaching the intraocular lens to the anterior side of the iris of the eye by inserting a helical coil fastener through the distal end of the tactile element and rotatably inserting the helical coil fastener into the iris to compress a portion of the tactile element between the top of the helical coil fastener and the anterior side of the iris. The helical coil fastener includes a wire with a pointed end.

[0013] In another embodiment, a surgical tool for attaching an intraocular lens to the iris includes a handle, a cannula, and an actuator. The handle has user-accessible actuator control. The cannula extends from an end of the handle and includes a proximal opening and a distal opening. The distal opening is oriented at a non-linear angle relative to the proximal opening. The cannula is configured to allow rotation and translation of a helical coil fastener therein. The actuator is configured to translate the helical coil fastener from the interior of the cannula through the distal opening of the cannula in response to actuator control. The surgical tool is configured to rotate the helical coil fastener as it exits through the distal opening of the cannula. Attached Figure Description

[0014] Figure 1A It is a cross-sectional view of the human eye;

[0015] Figure 1B yes Figure 1A A cross-sectional view of half of the iris;

[0016] Figure 2AThis is a top perspective view of an exemplary artificial lens assembly (IOL assembly) including an exemplary artificial lens (IOL), the exemplary artificial lens (IOL) including an exemplary optical element, at least one tactile element for securing the IOL to the iris of the eye, and an exemplary spiral coil fastener configured to engage with the tactile element to attach the IOL to the iris.

[0017] Figure 2B yes Figure 2A A top view of the IOL components and the eye;

[0018] Figure 2C yes Figure 2A A side view of the IOL components and the eye;

[0019] Figure 2D This is a top view of the optical components of the IOL assembly, which is similar to... Figure 2A The IOL component in the middle, but an optical component with multiple and / or various corrective capabilities within a single optical element;

[0020] Figure 2E yes Figure 2A Top perspective view of the spiral coil fastener;

[0021] Figure 2F yes Figure 2A Bottom view of the helical coil fastener;

[0022] Figure 2G yes Figure 2A Side view of a spiral coil fastener;

[0023] Figure 3A This is a top perspective view of a step in an exemplary surgical method for treating human eye conditions using an IOL component, which includes... Figures 2A-2G The IOL and spiral coil fasteners, and more specifically, the top perspective view illustrates the insertion of the IOL into the eye;

[0024] Figure 3B This is a top perspective view illustrating the adjustment of implant components within the eye;

[0025] Figure 3C This is a top perspective view illustrating an exemplary fastener applicator tool positioned relative to the IOL and inserted into the eye;

[0026] Figure 3D yes Figure 3C The fastener applicator tool in the image applies a spiral coil fastener to the cross-sectional side view of the tactile component of the IOL;

[0027] Figure 3E yes Figure 3DThe spiral coil fastener attaches the IOL to the iris in a cross-sectional side view.

[0028] Figure 4A This is a top view illustrating an exemplary closed foot cavity having a bottom wall at the distal end of the tactile component of an intraocular implant assembly (IOL).

[0029] Figure 4B This is a top view illustrating another exemplary embodiment of an open foot cavity with a bottom wall;

[0030] Figure 4C This is a top view illustrating another exemplary embodiment of a closed foot cavity including a through hole;

[0031] Figure 4D This is a top view illustrating another exemplary embodiment of an open foot cavity including a through hole;

[0032] Figure 4E This is a top view showing another exemplary embodiment of a closed foot cavity with countersunk holes;

[0033] Figure 4F This is a top view illustrating another exemplary embodiment of an open foot cavity with countersunk holes;

[0034] Figure 4G This is another exemplary embodiment of a closed foot cavity with a retaining pin;

[0035] Figure 4H This is another exemplary embodiment of an open foot cavity with a retaining pin;

[0036] Figure 4I This is another exemplary embodiment of a closed foot cavity with a retaining pin;

[0037] Figure 4J This is another exemplary embodiment of an open foot cavity with a retaining pin;

[0038] Figure 5A This is a side perspective view of a bi-flange pad ring at the distal end of the tactile component of an IOL (Intraocular Ocular Implant) assembly, the bi-flange pad ring including a top flange and a bottom flange for attachment to the IOL before it is inserted into the eye.

[0039] Figure 5B This is a side perspective view of an exemplary single-flange gasket, which includes only a top flange for attaching to the IOL after it has been inserted into the eye;

[0040] Figure 5C yes Figure 5B A cross-sectional side view of a single-flange washer and a helical coil fastener, with the helical coil fastener in a retracted orientation relative to the single-flange washer;

[0041] Figure 5D yes Figure 5B A cross-sectional side view of a single-flange washer and a helical coil fastener, the helical coil fastener being in an extended orientation relative to the single-flange washer;

[0042] Figure 6 This is a side view of an exemplary spiral coil fastener with a protective gasket;

[0043] Figure 7 This is a top perspective view of another exemplary embodiment of a helical coil fastener, having a head including the tip of a wire extending beyond the outer diameter of a helical element.

[0044] Figure 8 This is a top perspective view of another exemplary embodiment of a helical coil fastener, having a cap with circumferentially spaced mechanical notches and a fastener applicator tool engaging therewith.

[0045] Figure 9 This is a side view of another exemplary embodiment of a spiral coil fastener, which has a groove along the length of the line;

[0046] Figure 10 This is a side view of another exemplary embodiment of a helical coil fastener with an angled tip;

[0047] Figure 11 This is a perspective view of an exemplary digital fastener applicator tool for applying a spiral coil fastener to the iris to attach an IOL to the iris;

[0048] Figure 12 This is a perspective view of an exemplary mechanical fastener applicator tool for applying a helical coil fastener to the iris to attach an IOL to the iris;

[0049] Figure 13 It is possible Figure 11 and / or Figure 12 A perspective view of an exemplary rotary cam and mandrel used in a fastener applicator tool;

[0050] Figure 14A This is a cross-sectional view of a digital fastener applicator tool used to apply helical coil fasteners to the iris to attach the IOL to the iris;

[0051] Figure 14B The diagram illustrates a straight orientation. Figure 14A A side view of the distal end of the sleeve of a digital fastener applicator tool;

[0052] Figure 14C The diagram illustrates a bending orientation. Figure 14AA side view of the distal end of the sleeve of a digital fastener applicator tool;

[0053] Figure 15 This is a cross-sectional side view of an exemplary applicator tool that attaches fasteners and / or anchors from outside the eye via an external heat source;

[0054] Figure 16A This is a top perspective view of another exemplary embodiment of an intraocular implant assembly using a fastener applicator tool having a friction drive wheel that engages screw fasteners to attach the IOL to the iris.

[0055] Figure 16B It is in an open orientation for use with Figure 16A Bottom perspective view of the anchor used with screw fasteners;

[0056] Figure 16C It is in a closed orientation Figure 16B Bottom perspective view of the anchor;

[0057] Figure 17 This is a perspective view of an exemplary IOL component with integrated thumbtack fasteners;

[0058] Figure 18 It is a perspective view of a closed channel within the tactile foot of an IOL component, which has vertical hook fasteners positioned within the tactile foot.

[0059] Figure 19 It is a perspective view of an open channel in the tactile foot of an IOL component, which has a vertical hook fastener positioned within the open channel;

[0060] Figure 20 This is a side view of an exemplary fishhook fastener used to engage the tactile element and penetrate the front surface of the iris to attach the IOL to the iris.

[0061] Figure 21A This is a side view of an exemplary tack fastener used to engage the tactile element and penetrate the front surface of the iris to attach the IOL to the iris.

[0062] Figure 21B It is used for attachment Figure 21A A perspective view of the fastener applicator tool for thumbtack fasteners;

[0063] Figure 22A This is a perspective view of the spring clip fastener used to engage the tactile element and penetrate the front surface of the iris to attach the IOL to the iris;

[0064] Figure 22B It is positioned above the raised part of the IOL haptic component. Figure 22AA perspective view of the spring clip fastener, with an enlarged foot to prevent the IOL from detaching from the spring clip;

[0065] Figure 23A It is a perspective view of a helical coil fastener with a rectangular ring head;

[0066] Figure 23B It is used for attachment Figure 23A A perspective view of the head of a fastener applicator tool for a helical coil fastener;

[0067] Figure 24A This is a perspective view of a U-shaped fastener;

[0068] Figure 24B It is used for attachment Figure 24A Perspective view of the fastener applicator tool for U-shaped fasteners;

[0069] Figure 25A This is a perspective view of an IOL assembly with spring-loaded wing fasteners; and

[0070] Figure 25B It is used to Figure 25A A perspective view of the IOL component's spring wing fasteners attached to the fastener applicator tool within the iris. Detailed Implementation

[0071] The embodiments disclosed herein include intraocular lenses (IOLs) and related components, implants, and intraocular attachment methods. In some aspects, a helical coil fastener, along with associated applicator tools and surgical insertion methods, is provided to attach the IOL to the iris relative to the pupil. In one embodiment, the IOL component includes a helical coil fastener to attach the IOL to the iris to correct astigmatism, presbyopia, and / or myopia or hyperopia. An IOL can be implanted to correct visual errors while the patient's natural lens is removed or left in place. The IOL can be used as a phakic implant (e.g., for use in the presence of a lens) or as an aphakic implant (e.g., for use in the absence of a lens). The IOL has optics for correcting astigmatism and / or myopia or hyperopia (e.g., a first optical effect). The IOL can also have another optical effect (e.g., a second optical effect) to address presbyopia (e.g., as a phakic IOL operating at up to 2.0 diopters) or as a non-phakic IOL (e.g., up to 4.0 diopters) to address presbyopia. The optic also has one or more tactile elements extending from its periphery, configured to facilitate attachment of the IOL to the iris relative to the pupil. The tactile elements can be arched to minimize contact with the iris while maintaining an appropriate distance from the cornea. In this regard, a helical coil fastener is provided, configured to engage the optic to attach the IOL to the iris. The helical coil fastener includes a head and a spiral extending from the bottom surface of the head and including a pointed tip opposite the head. Once the IOL is positioned relative to the pupil, the helical coil fastener is configured to be applied to the distal end of each tactile element to penetrate the anterior surface of the iris at an oblique angle, thereby attaching the IOL relative to the pupil. The helical coil fastener is configured to be attached to the iris by rotatably penetrating it, and thus removed from the iris by reverse rotation of the helical coil fastener. The helical coil fastener features a small volume, large surface area, small penetration cross-sectional area, and penetration angle. Therefore, the helical coil fastener is easy to apply, easy to remove, minimizes tissue damage, maximizes stability, and minimizes penetration force.

[0072] Further embodiments disclosed herein relate to other fasteners, IOLs, IOL assemblies, and methods for attaching an IOL to the iris for correction and astigmatism, with and without presbyopia vision correction. In this regard, some further embodiments provide fasteners configured to engage the optical components of the IOL for attaching the IOL to the iris. These further embodiments may also have one or more features to facilitate and / or control the fastener insertion position and / or insertion depth when attaching the IOL to the iris.

[0073] The discussion focuses on structures designed to be implanted in the eye to provide [treatment / care]. Figure 2ABefore starting the corrective intraocular implant components, regarding Figure 1A and Figure 1B Provide a brief description of the human eye.

[0074] In this respect, Figure 1A and Figure 1B It is the view as seen by the human eye. More specifically, Figure 1A It is a cross-sectional view of the human eye, and Figure 1B yes Figure 1A A cross-sectional view of half of the iris of the human eye. The human eye 100 includes the cornea 102, iris 104, sclera 106, vitreous body 108, anterior chamber 110, angle 112, trabecular meshwork 114, posterior chamber 116, and lens 118. (Turning) Figure 1B The iris 104 controls the amount of light entering the eye 100 and is composed of a stroma 120, dilators 122, and sphincters 124, which are attached beneath the iris 104 by pigment epithelium 126. The dilators 122 and sphincters 124 are connected by nerves passing through the pigment epithelium 126 and the iris stroma 120, and operate as a group to control the diameter of the pupil 128 (e.g., iris opening, pupil opening). Furthermore, the pigment epithelium 126 constitutes approximately five percent (5%) of the total thickness of the iris 104. The opening and closing of the iris 104 is controlled by the sphincters 124 and dilators 122, which are functionally interconnected beneath the iris 104 by the pigment epithelium 126 and the nerves and nerve endings present therein. Note that nutrients are transported to the iris 104 from the root of the iris.

[0075] Although the diameter of the iris 104 will vary between individuals in terms of eye 100 size, the distance from the edge of the pupil 128 to the anterior edge of the dilatation muscle 122 is similar for all mature human eyes. Furthermore, the dilatation muscle 122 and the sphincter muscle 124 are not directly connected, and the iris tissue between muscles 132 and 134 does not move; thus providing an ideal location for attaching the intraocular implant component (discussed in more detail below) inside the eye 100 without interfering with the natural functioning of the eye 100. Given the foregoing, as long as the attachment device is positioned between the sphincter muscle 124 and the dilatation muscle 122 without penetrating the iris 104, the eye 100 will experience minimal trauma in both the short and long term, and the implant component should be well tolerated. Therefore, penetration between five percent (5%) and ninety-five percent (95%) of the iris 104 should securely attach the intraocular implant component to the iris 104 without interfering with the basal nerves of the five percent (5%) where the pigment epithelium 126 is located.

[0076] Although the above description specifically references the human eye 100, it should be understood that the devices and methods described herein can be applied to a variety of animals. For example, mammals such as dogs, cats, and horses are harmed when their vision declines with age, and the vision correction surgery disclosed herein can prevent damage and thereby extend their lifespan.

[0077] Figures 2A-2G This is a view of an exemplary intraocular implant component. Figures 2A-2C As shown, an IOL assembly 210 is provided, configured to be implanted in an eye 100 (e.g., a human, mammal, etc.) for use with or without a lens 118. The IOL assembly 210 includes an IOL 212 and one or more helical coil fasteners 214. The helical coil fasteners 214 attach the IOL to the eye 100 and provide a small volume, large surface area, small insertion cross-sectional area, and insertion tilt angle. Therefore, the helical coil fasteners 214 are easy to apply, easy to remove, minimize tissue damage, maximize stability, and minimize insertion force. The IOL 212 includes an optic 216, a left tactile element 218A extending from the left periphery of the optic 216, and a right tactile element 218B extending from the right periphery of the optic 216 (the left and right tactile elements 218A, 218B arch the optics away from the anterior surface of the iris 104). The optical properties of the IOL 212 of the IOL assembly 210 allow it to work in conjunction with the human optical system (i.e., the cornea 102 and the human lens 118) to correct errors such as myopia, hyperopia, presbyopia, and astigmatism. The IOL 212 of this disclosure is characterized by a minimal tissue contact area with the iris 104 (e.g., less than 7 square millimeters, preferably between 1.5 and 5.0 square millimeters) and the ability to be easily inserted and removed with minimal trauma to the ocular tissue.

[0078] Optical element 216 is typically circular and has a front side (e.g., closer to the eye 100), a back side (e.g., further away from the eye 100), and an outer periphery. The diameter of optical element 216 can range from approximately 5 mm to 7 mm. Furthermore, depending on whether myopia or hyperopia is being corrected, optical element 216 can have different anterior and posterior curvatures. Further curvature variations are added and incorporated for correcting cylindrical lenses (astigmatism), presbyopia, bifocal or multifocal conditions, and include aspheric, extended-range focusing or vision, and refractive or diffractive optics. The characteristics of the selected specific optical element 216 are left to the surgical judgment of the physician performing the implantation surgery.

[0079] To facilitate anterior fixation of the IOL 212 to the iris, one or more tactile elements 218A, 218B are connected to the optics 216. The tactile elements 218A, 218B extend outward from the optics 216 and are circumferentially spaced apart from each other (around the periphery of the optics 216). The left tactile element 218A includes a left first raised portion 220A (e.g., a left first arm, a left first arch) and a left second raised portion 222A (e.g., a left second arm, a left second arch). The left first raised portion 220A extends from the left periphery of the optics 216 (e.g., at the proximal end of the left first raised portion 220A) to the left foot portion 224A of the tactile element 218A (e.g., at the distal end of the left first raised portion 220A). Similarly, the left second raised portion 222A extends from the left periphery of the optics 216 at its proximal end to the left foot 224A of the tactile element 218A. The left first raised portion 220A and the left second raised portion 222A are attached to the opposite ends of the left foot 224A. This arrangement creates a left aperture 232A between the left periphery of the optics 216 and the left foot 224A.

[0080] Similarly, the right haptic member 218B includes a right first raised portion 220B (e.g., a right first arm, a right first arched portion) and a right second raised portion 222B (e.g., a right second arm, a right second arched portion). The right first raised portion 220B extends from the right periphery of the optics 216 (e.g., at the proximal end of the right first raised portion 220B) to the right foot 224B of the haptic member 218B (e.g., at the distal end of the first raised portion 220B). Similarly, the right second raised portion 222B extends from the right periphery of the optics 216 at the proximal end of the right second raised portion 222B to the right foot 224B of the haptic member 218B. The right first raised portion 220B and the right second raised portion 222B are attached to opposite ends of the right foot 224B. This arrangement creates a right aperture 232B between the right periphery of the optics 216 and the right foot 224B.

[0081] Therefore, each raised portion 220A, 222A, 220B, 222B includes a proximal end, a distal end, and an intermediate portion therebetween. The raised portions 220A, 222A, 220B, 222B project downwards away from the rear side of the optics 216 to arch the IOL 212 and the raised portions 220A, 222A, 220B, 222B away from the iris 104, minimizing tissue contact and providing an arched space 223 between the underside of the IOL 212 and the anterior surface of the iris 104 (e.g., the left and right foot portions 224A, 224B are positioned at different heights from the optics 216). The proximal and distal ends of the tactile raised portions 220A, 222A, 220B, 222B maintain the optics 216 in a spaced-apart relationship with the iris 104. In other words, the left and right tactile feet 224A, 224B support the IOL 212 on the anterior surface of the iris 104, and the left and right tactile feet 224A, 224B are the only parts of the IOL 212 in contact with the iris 104. Minimizing the surface contact between the IOL 212 and the iris 104 reduces deterioration, irritation, and trauma to the iris 104. The surface contact area between the tactile device and the iris can be further minimized by using small protrusions, dots, ridges, or ridges on the posterior surface of the tactile feet that serve as contact points on the iris.

[0082] like Figure 2C As shown, the left haptic foot 224A includes an inner wall 225A that defines a cavity 226A (e.g., a fastener socket, coil socket, hole, engagement hole, aperture, opening, etc.) extending downward from the rear surface of the foot 224A. A helical coil fastener 214 is positioned within the foot cavity 226A to secure the IOL 212 to the iris 104 (discussed in more detail below). Similarly, the right haptic foot 224B includes an inner wall 225B that defines a cavity 226B (e.g., a hole, aperture, opening) extending downward from the rear surface of the foot 224B. A helical coil fastener 214 is positioned within the foot cavity 226B to secure the IOL 212 to the iris 104 (discussed in more detail below).

[0083] Wherever reference is made to the left haptic 218A (and portions thereof) in this description, the description may also be applied to the right haptic 218B (and portions thereof) and vice versa.

[0084] Tactile elements 218A and 218B may be configured with mechanical pawls or threads to prevent the helical coil fastener 214 from accidentally advancing into the iris tissue, to control the advancing or tightening process of the helical coil fastener 214, and / or to prevent the helical coil fastener 214 from accidentally disengaging (e.g., loosening unless engaged by a actuator of the medical instrument). Furthermore, on the rear surface of tactile elements 218A and 218B, one or more small protrusions, dots, ridges, and / or ridges may serve as legs to prevent any swaying movement of the IOL 212 while providing minimal surface area contact with the iris 104 (opposite to the rear surface of the IOL tactile elements 218A and 218B that contacts the iris 104).

[0085] Optical element 216 and tactile elements 218A, 218B must be made of a bio-inert material, and optical element 216 must additionally be made of a material that meets the necessary optical and surgical insertion requirements. The term "bio-inert" is generally understood in the art to mean a material that is not absorbed by bodily fluids and does not cause any adverse reactions upon implantation. Common materials used alone or in combination for IOLs include, among others, silicone, acrylic, collagen, hydrogel, and polymethyl methacrylate. Other suitable materials may include ophthalmic glass, quartz, and other polymeric materials.

[0086] like Figure 2D As shown, an alternative optics 216-1 similar to optics 216 can be provided, but it can have multiple corrective powers and / or various corrective powers within a single, concentrically positioned optics 216. These corrective powers can be used to correct astigmatism or presbyopia and / or myopia or hyperopia using refractive optics, diffractive optics, aspherical optics, and extended-range focusing or vision optics. Optics 216-1 can have an optical effect for correcting astigmatism and / or myopia or hyperopia (e.g., a first optical effect). Optics 216-1 can also have another optical effect for addressing presbyopia (e.g., a second optical effect) (e.g., combined with a lens working up to 2.0 diopters). The first and second optical effects can be concentrically positioned around the center of optics 21, can be repeated (e.g., in a concentric alternating pattern), and / or can vary in band thickness. IOL 212 can be used as a phakic implant (e.g., for use in cases with a lens) or as a non-phakic implant (e.g., for use in cases without a lens).

[0087] Optical components 216 and 216-1 can be implanted to supplement natural (or implanted) lenses or replace natural lenses. For the process where optical components 216 and 216-1 are configured to operate with a natural human lens (remaining in place), optical components 216 and 216-1 can be selected to produce pre-selected optical effects, such as myopia of +1 to +30 diopters, hyperopia of -1 to -20 diopters, astigmatism of + / -1 to + / -8 diopters up to + / -180 degrees, and presbyopia of 0.5 to 2 diopters or 2.5 to 4 diopters. For the process in which optics 216 and 216-1 are configured to operate in the absence of a natural human lens (which is removed), optics 216 and 216-1 can be selected to produce preselected optical effects, such as +1 to +30 diopters of myopia, -1 to -20 diopters of hyperopia, + / -1 to + / -8 diopters of astigmatism at up to + / - 180 degrees, and 0.5 to 2 diopters or 2.5 to 4 diopters of presbyopia. Optics 216 and 216-1 may include one or more optical features that can be concentrically positioned, such as refractive features (e.g., refracting lenses), diffraction features, multifocal features (different focusing lenses with concentric positioning), bifocal features (different focusing lenses with concentric positioning), aspherization features, extended range focusing or vision, etc.

[0088] Even when presbyopia is present, the natural human lens provides a certain amount of accommodation. The accommodation provided by the natural human lens is added to the presbyopia correction power provided in the IOL 212. By providing presbyopia correction via the IOL 212, which is adapted to work in conjunction with the human lens, a smaller presbyopia correction power (i.e., diopter) may be required to correct presbyopia. Limiting the presbyopia correction power is advantageous because for a given increase in diopter power, undesirable optical effects increase non-linearly. In providing presbyopia correction, optics 216, 216-1 can resolve refraction to correct distance errors. In this way, providing presbyopia correction power does not increase refractive distance errors. For example, if refractive errors increase, distance errors increase, thereby increasing existing myopia or hyperopia, which in turn can lead to the need for additional correction, such as through glasses. Using the IOL 212, refractive correction can be used to make the patient emmetropia (i.e., without refractive distance errors). Therefore, presbyopia correction does not increase refractive distance error. Note that any further discussion below regarding optics 216 may include... Figure 2D Optical component 216-1.

[0089] like Figures 2C-2GAs shown, the helical coil fastener 214 includes a head 234 (e.g., a top) and a helix 236 (e.g., a coil, helical coil, spring coil, plug, bottom, etc.) extending from its bottom surface. The helical coil fastener 214 anchors the IOL 212 to the iris 104. The helix 236 (e.g., a helical coil) includes a top end (not shown) extending from the bottom surface of the head 234 and a tip 238 (e.g., a sharp point) at its bottom end. The width of the head 234 (e.g., head width) can be the same as, wider than, or smaller than the helical diameter of the helix 236. The helical coil fastener 214 reduces damage to the iris tissue and allows the iris tissue to return to its native state after removal. For example, compared to a threaded screw, the helical coil fastener 214 can have the same depth of penetration, increased surface area, reduced penetration volume, and reduced penetration cross-sectional area. The increased surface area of ​​the helical coil fastener 214 provides a larger surface area to extend the holding force (reducing the risk of accidental detachment or tearing of the iris 104). Unlike screws, the helical coil fastener 214 does not rely on threads for retention and requires minimal axial force for insertion and opening. More specifically, the helical coil fastener 214 has adjustable properties, resisting forces transmitted from the IOL 212 to the iris tissue or from the iris tissue to the IOL 212. This flexibility is particularly useful in dynamic environments and conditions, whether the pull-out force is applied perpendicular to the iris tissue plane or at an angle (e.g., 45 degrees) to the iris tissue plane, or whether vibration or rotational forces are applied simultaneously. In contrast, screws and similar attachments are more susceptible to lower pull-out forces within vibrational or rotational pull-out forces.

[0090] Additionally, the helical coil fastener 214 is self-guided. The helical coil fastener 214 may be made of stainless steel, spring steel, Elgiloy corrosion-resistant hairspring alloy, hyperelastic materials (e.g., nitinol), titanium, or polymers (e.g., nylon, polypropylene, acrylic, PEEK, PET, etc.) or other biocompatible materials (e.g., having a suitable stability distribution for implantation). In particular, hyperelastic materials (e.g., nitinol) can withstand large deformations without yielding.

[0091] The head 234 and / or helix 236 of the helical coil fastener 214 can be constructed (e.g., sized and / or shaped) to fit within the IOL haptic cavity 226A, 226B, such that the circumference and / or diameter of the helix 236 can be slightly smaller than the circumference and / or diameter of the IOL haptic foot cavity 226. Furthermore, after the periphery of the helix 236 penetrates the iris tissue and exits the rear surface of the IOL 212, the circumference and / or diameter of the helix 236 can be swept out (e.g., enlarged), such that the circumference and / or diameter of the helix 236 is larger than the circumference and / or diameter of the IOL haptic cavity 226A, 226B. The circumference of the helix 236 can vary from a tapered coil shape to a larger coil. In an alternative embodiment, the dimensions of the helix 236 can be configured to fit within a matching tread or groove within the IOL haptic cavity 226A, 226B. For example, the IOL haptic component cavities 226A and 226B can be molded using internal threads.

[0092] The helical coil fastener 214 is configured to penetrate a portion of the entire iris 104 but less than the entire iris 104 (e.g., half the thickness of the iris 104) to avoid penetrating the pigment epithelium 126. The amount of penetration and contact area can vary depending on the quality of the IOL, the number and structure of the tactile elements 218A, 218B, the arching of the optical element 216 to the tactile elements 218A, 218B, and / or other factors. Note that the helical coil fastener 214 has sufficient length to avoid interfering with normal iris function (e.g., the muscles controlling the opening and closing of the pupil 128 (dilatation muscles 122 and sphincter muscles 124)).

[0093] The helix 236 of the spiral coil fastener 214 minimizes the cross-sectional area (e.g., cross-sectional profile) during insertion and / or removal, which also reduces the force required to penetrate and engage the iris 104. Furthermore, the helix 236 provides good shock absorption. Additionally, the tip 238 penetrates and enters the iris 104 at an angle, thereby reducing the force required to penetrate and engage the iris 104 and resisting tearing of the iris tissue. The rotational force screwed into the spiral coil fastener 214 reduces the axial insertion force required to penetrate the iris 104. Similarly, the spiral coil fastener 214 can be unscrewed from the iris tissue and folded back along the insertion path to minimize tissue damage (e.g., reduce the likelihood of tearing or destroying the iris tissue). This is a significant improvement compared to screws that penetrate the tissue axially (non-angled), require a large axial insertion force to initiate a proper threaded connection, and have a large cross-sectional area during insertion and / or removal. Additionally, the front surface of the helical coil fastener 214 and / or IOL 212 may include mechanical interference features (e.g., tabs, platforms, and / or other mechanical pawls on the front surface of the helical coil fastener head 234 and / or IOL 212) to prevent the helical coil fastener 214 from accidentally rotating and dislodging from the iris tissue.

[0094] The head 234 of the helical coil fastener 214 helps limit the maximum depth of penetration of the helical coil fastener 214 and controls the amount of material of the helical coil fastener 214 placed in the iris 104 (e.g., to limit the rear profile of the helical coil fastener 214). This reduces the likelihood of complete penetration into the iris tissue because the attachment mechanism ideally increases the holding force (e.g., gripping and anchoring) within the gap space of the iris 104. The head 234 may be flat and / or have a minimal profile. Additionally, the head 234 may have engagement features (e.g., a member, slot, hole, ridge, protrusion, or other mechanical features) to receive a medical instrument supplying rotational force. For example, for head engagement, the head 234 of the medical instrument and the actuator may be connected via a periphery (e.g., a hexagonal head), mechanical pawls (e.g., cross-shaped, grooved, raised, ridged, etc.), magnetic energy, vacuum energy, clamping force, etc. The head shape can be dome-shaped, flat, recessed in the spiral 236, and / or formed by the top of the spiral 236 itself (described in more detail below).

[0095] The spiral 236 can be made of a circular, D-shaped, flat, or any combination of these shapes. In some instances, a flat-line design can provide greater penetration and insertion force due to the rectangular aspect of the flat line resisting lateral movement. A D-shaped line can provide a lower profile for insertion into the tissue due to the smaller mass of the penetrating member within the tissue. The spiral 236 can have various pitch configurations, including open (e.g., where the coils slightly separate with each rotation) or closed (e.g., where the coils almost contact adjacent pitches with each rotation). The pitch angle of the spiral 236 can vary from 5 degrees to 45 degrees relative to the planar surface of the iris tissue. The pitch angle of the spiral 236 can vary over the entire length or height of the spiral 236. This pitch can be changed once it leaves the posterior surface of the IOL 212 (described in more detail below). For penetration into the iris tissue, the tip 238 of the spiral 236 can be tapered, rhomboid, inclined with multiple flat edges or small planes, have a flat edge, and / or have an eccentric tip, etc.

[0096] The helical coil fastener 214 can also be self-rotating. For example, the helix 236 can be made of a shape memory material that unfolds into the tissue or automatically winds itself once released. In the wound state, the helix 236 possesses potential energy. Once released, the helix 236 unwinds and screws into the iris tissue. In another embodiment, the helix 236 can be pre-loaded in a pre-wound state into the foot cavity 226 of the IOL haptic device. Once the IOL assembly 210 is placed in the anterior chamber 110 and positioned in place on the iris 104 by a physician, the helical coil fastener 214 can be pushed downward through the foot cavity 226 of the IOL haptic device. Once mechanically displaced, the helix 236 of the helical coil fastener 214 unwinds and thereby screws into the iris tissue.

[0097] Furthermore, the spiral 236 is spring-like and elastic, providing benefits related to material fatigue. When the spiral 236 is compressed or under tension, its shape and material properties tend to revert to their natural or annealed state. The spiral 236 creates an attachment mechanism, which functions as a suspension system for connecting the IOL 212 to the iris tissue. Forces delivered to the iris tissue can be suppressed by the properties of the spiral 236 to prevent force transmission to the rest of the IOL 212 or to the opposite attachment point on the IOL 212. Suppressive properties can be generated within specific portions of the spiral 236, such that the portion of the spiral 236 screwed into the iris tissue has a smaller suppressive property, and the portion adjacent to or near the rear surface of the IOL 212 has a larger suppressive property. The suppressive portions of the spiral 236 can be primarily located within and around the cavities of the haptic foot 226A, 226B. For the spring coil shape, the helical coil fastener 214 has damping or shock-absorbing properties, which can help limit the force delivered to the IOL 212 from being transmitted to the iris tissue, and vice versa. The effect of weakening the force through the attachment system can reduce the tendency for stress concentration and provide greater fatigue strength to the IOL.

[0098] Figure 2F This is a bottom view of the helical coil fastener 214. The wire 236 of the helical coil fastener 214 has a wire diameter, which is the width or thickness of the wire 236 itself. The helix formed by the wire 236 of the helical coil fastener 214 defines an outer diameter (e.g., helix diameter, coil diameter), and the wire 236 defines a generally cylindrical hollow center (e.g., inner diameter, gap, etc.) with a second diameter (hollow center diameter). The IOL haptic foot cavities 226A, 226B may have haptic hole diameters. The dimensions of the helical coil fastener 214 and the corresponding IOL haptic foot cavities 226A, 226B can have various dimensions. For example, the wire diameter (W) can be between 0.125-1 mm, the helix diameter (D1) can be between 1-3 mm, the hollow center diameter (D2) can be between 0.5-2.5 mm, and the haptic hole diameter can be between 1.0-3.0 mm. The depth of the helical element (e.g., 0.5 to 3 mm) can be approximately the same as (or slightly smaller than) the depth of the tactile element hole (e.g., 0.5 to 3 mm). The diameter of the helical element can be approximately the same as (or slightly larger than) the diameter of the tactile element hole for frictional engagement. Smaller and larger wire diameters can be used for the helical coil. The following is a dimensional table for several different exemplary embodiments.

[0099] tactile component hole diameter Coil diameter (D1) Wire diameter (W) Hollow center diameter (D2) The ratio of D1 to W 1.0mm 1.0mm 0.125mm 0.75mm 8:1 1.0mm 1.0mm 0.25mm 0.5mm 4:1 1.5mm 1.5mm 0.125mm 1.25mm 12:1 1.5mm 1.5mm 0.25mm 1.0mm 6:1 1.5mm 1.25mm 0.25mm 0.75mm 2:1 1.5mm 1.0mm 0.25mm 0.5mm 4:1 1.5mm 1.5mm 0.5mm 0.5mm 3:1 2.0mm 2.0mm 0.125mm 1.75mm 16:1 2.0mm 2.0mm 0.25mm 1.5mm 8:1 2.0mm 2.0mm 0.5mm 1.0mm 4:1 2.0mm 1.5mm 0.25mm 1.0mm 6:1 2.5mm 2.5mm 0.125mm 2.25mm 20:1 2.5mm 2.5mm 0.25mm 2.0mm 10:1 2.5mm 2.5mm 0.5mm 1.5mm 5:1 2.5mm 2.5mm 1.0mm 0.5mm 5:2 3.0mm 3.0mm 0.125mm 2.75mm 24:1 3.0mm 3.0mm 0.25mm 2.5mm 12:1

[0100] Figure 2GThis is a side view of the helical coil fastener 214. As shown, the thread 236 of the helical coil fastener 214 includes a pitch (P). The pitch can vary depending on the desired penetration depth, penetration angle, holding force requirement, etc. Furthermore, the pitch can be constant or variable (e.g., to increase the holding force of the helical coil fastener 214 within the iris 104). As shown, each coil turn of the thread 236 defines a different angle (Ө). More specifically, a first angle (Ө1) defines the penetration angle between the tip 238 and the front surface of the iris 104. A second angle (Ө2) defines the angle between the first and second coil turns, and a third angle (Ө3) defines the angle between the second and third coil turns. A fourth angle (Ө4) defines the angle between the third coil turn and the bottom surface of the helical coil fastener head 234. The first angle (Ө1) and the fourth angle (Ө4) can be substantially the same, and / or the second angle (Ө2) and the third angle (Ө3) can be substantially the same. Alternatively, they can be different (e.g., if the pitch of the wire 236 is variable). As each subsequent coil turn is rotatably inserted into the iris 104, the helical coil fastener 214 increases its holding force (e.g., gap space) within the iris 104.

[0101] In another embodiment (not shown), a helical coil fastener 214 can connect the IOL 212 to the iris tissue such that the IOL 212 floats above the iris tissue and / or has minimal contact with the iris tissue. In other words, the tactile feet 224A, 224B will not contact the front surface of the iris 104, thereby reducing the impact of the IOL 212 on the iris 104 (e.g., the entire surface contact area). In this way, the helix 236 can create a predetermined distance or space between the iris 104 and the rear surface of the IOL 212. This can be achieved together with the tabs or arches of the IOL tactile elements 218A, 218B located directly above the front surface of the iris 104.

[0102] Figures 3A-3E The diagram illustrates, for example, what can be used for surgical insertion and attachment. Figures 2A-2G An exemplary surgical insertion and fixation view of the intraocular implant component of IOL 212.

[0103] like Figure 3AAs shown, a small incision 300 (e.g., between 1.8 mm and 4.0 mm, etc.) is made in the cornea 102 or sclera 106 of the eye 100 (e.g., by a doctor or ophthalmologist). An inserter 302 (e.g., an insertion instrument, IOL shooter, etc.) defining a channel 304 and having an angled periphery 306 at the distal opening is then inserted into the incision 300. The angled periphery 306 facilitates partial insertion of the inserter 302 through the incision 300. The inserter 302 also includes a piston 308 within the channel 304. The channel 304 of the inserter 302 includes a folded (e.g., deformed, bent, rolled, etc.) IOL 212 within the channel 304, positioned closer to the distal opening than the piston 308. Folding the IOL 212 reduces the overall insertion size of the IOL 212, thereby minimizing the size of the required incision 300.

[0104] Once the angled periphery 306 and / or a portion of the channel 304 of the inserter have been inserted into the incision 300, the distal opening of the inserter 302 is positioned and approximately centered above the pupil 128. The piston 308 is then translated toward the distal opening, thereby pushing the folded IOL 212 out of the distal opening into the anterior chamber 110 of the eye 100 (e.g., above the pupil 128). Once the IOL 212 is pushed into the anterior chamber 110, the IOL 212 unfolds naturally. The IOL 212 can be positioned within the channel 304 such that the anterior surface of the IOL 212 is aligned with the distal end of the angled periphery 306 of the inserter 302. This facilitates proper orientation of the inserter 302 by the surgeon and ensures that the posterior surface of the IOL 212 is close to the anterior surface of the iris 104 when the IOL 212 unfolds.

[0105] exist Figure 3B In this procedure, an IOL 212 is positioned within the anterior chamber 110 of the eye using a paddle 310 or similar instrument (e.g., a hook, a twister, etc.) having a shaft 312 and a bulbil end 314, such that the IOL optics 216 are properly positioned over the pupil 128 of the eye 100. More specifically, the bulbil end 314 is inserted through the incision 300 and contacts the IOL 212 to push, pull, and / or rotate the IOL 212 relative to the pupil 128. The IOL 212 is preferably oriented such that the IOL tactile elements 218A, 218B are oriented from left to right over the patient's eye 100. When the IOL tactile elements 218A, 218B are oriented to conform to the patient's (e.g., the eyelid's) natural eye opening, this facilitates implantation by the surgeon.

[0106] exist Figure 3COnce the IOL 212 is correctly positioned within the eye 100, the distal portion of the fastener applicator tool 370 (discussed in more detail below) is inserted through the cut 300. More specifically, the fastener applicator tool 370 includes a first sleeve 372 and a second sleeve 374, the second sleeve 374 being further than the first sleeve 372 and substantially perpendicular to the first sleeve 372. Preferably, the fastener applicator tool 370 is inserted through the cut 300 such that the second sleeve 374 is aligned with the cut, thereby reducing the extent to which the cut 300 must be widened to allow the distal portion of the fastener applicator tool 370 to pass through. The second sleeve 374 includes a distal opening 376. As shown, at least one helical coil fastener 214 is positioned within the fastener applicator tool 370, and more specifically, the helical coil fastener 214 is positioned within the second sleeve 374, near the distal opening 376. However, the fastener applicator tool 370 may be pre-loaded with multiple helical coil fasteners 214.

[0107] exist Figure 3D In this process, the distal opening 376 and at least a portion of the second sleeve 374 can be inserted into the left tactile foot cavity 226A of the IOL. The fastener applicator tool 370 then translates and rotates the helical coil fastener 214 through the distal opening 376, such that the tip 238 of the helical coil fastener 214 penetrates the iris 104 (between the dilatational muscle 122 and the sphincter muscle 124) and the helical coil fastener 214 engages (e.g., screws into) the iris tissue, but does not penetrate the pigmented epithelium 126. Once the helical coil fastener 214 is fully engaged, the fastener applicator tool 370 is removed. Accordingly, the IOL 212 is attached to the iris 104 through the arched space 223 between the optic 216 and the anterior surface of the iris 104.

[0108] When the helical coil fastener 214 exits the distal opening of the fastener applicator tool 370, the fastener applicator tool 370 can be configured to rotate and translate the helical coil fastener 214. Alternatively, the inner wall 225A of the IOL left haptic foot can be threaded (e.g., including mating threads) such that the fastener applicator tool 370 only translates the helical coil fastener 214 out of the distal opening, and the internal threads of the inner wall 225A of the IOL left haptic foot rotate the helical coil fastener 214. Furthermore, the fastener applicator tool 370 can be positioned above the IOL left haptic foot cavity 226A, but cannot be inserted into the IOL left haptic foot cavity 226A.

[0109] As shown, the left haptic foot 224A of the IOL includes a bottom wall 228A extending from an inner wall 225A into a cavity 226A adjacent to the rear surface of the IOL haptic foot 224A. The periphery of the bottom wall 228A defines an opening 230A. Similarly, the right haptic foot 224B of the IOL may also include a bottom wall 228A and an opening (not shown). A helix 236 extends through the opening 230A to penetrate the iris 104. A fastener applicator tool 370 facilitates the surgeon in ensuring that the helical coil fastener 214 does not penetrate the bottom wall 228A. Alternatively, the helical coil fastener 214 may penetrate the bottom wall 228A. Furthermore, the bottom wall 228A may extend throughout the entire bottom, such that the opening 230A is not defined, and the helical coil fastener 214 would have to penetrate the bottom wall 228A.

[0110] Tactile elements 218A, 218B may include one or more mechanical pawls on the rear surface of the tactile element feet 224A, 224B to prevent rotation of the IOL 212 when screwed into the helical coil fastener 214. Alternatively, the distal end of the fastener applicator tool 370 may have a mechanical pawl (e.g., a mechanical contact) that prevents movement of the IOL 212 when the helical coil fastener 214 is screwed into the iris tissue. The mechanical pawl may be shaped to receive features of the distal end of the fastener applicator tool 370 (similar to a hexagonal or other non-circular shape). Alternatively, the distal end of the instrument may have a surface shaped to engage the inner walls 225A, 225B of the IOL tactile element to prevent rotation or movement of the IOL 212 when the helical coil fastener 214 is screwed into place. Alternatively or concurrently, the surface at the distal end of the fastener applicator tool 370 (and / or the inner walls 225A, 225B of the IOL haptic element) may have a coefficient of friction that resists movement of the IOL 212. For example, a ring of silicone material around the circumference of the distal end of the fastener applicator tool 370 may be used. This silicone material prevents movement of the IOL 212 when the helical coil fastener 214 is screwed into place, presenting a non-traumatic or soft surface to the iris tissue at the leading edge of the distal end of the fastener applicator tool 370, and / or, if in contact with the distal end of the fastener applicator tool 370 during the insertion of the IOL haptic element foot cavity 226A, 226B or during the attachment process of placing the helical coil fastener itself, presenting a surface that will resist scraping the leading surface of the IOL 212.

[0111] Alternatively or concurrently, once the helical coil fastener 214 has entered the iris tissue and the fastener applicator tool 370 has been removed, the helical coil fastener 214 may expand within the IOL haptic foot cavities 226A, 226B. More specifically, instead of threading the helical coil fastener 214 into the inner wall 225A of the left IOL haptic foot (and / or using the bottom wall 228A of the left IOL haptic foot), the distal end of the fastener applicator tool 370 may be inserted into the IOL haptic foot cavities 226A, 226B for at least a portion of its length. The helical coil fastener 214 exits from the distal opening of the fastener applicator tool 370 and penetrates the iris tissue in a first configuration smaller than the inner diameter of the IOL left haptic foot cavity 226A. After the helical coil fastener 214 engages with the iris 104, and after the fastener applicator tool 370 is removed from the helical coil fastener 214 and the IOL left haptic foot cavity 226, at least a portion of the helix 236 expands above the front surface of the iris 104 (or springs back from below the front surface of the iris 104 into the IOL left haptic foot cavity 226) to present a second configuration larger than the inner diameter of the IOL left haptic foot cavity 226A, thereby contacting the inner wall 225 of the IOL left haptic foot and holding the IOL 212 in place. In this way, no downward force is delivered to the IOL during the tightening process of the helical coil fastener 214. For this embodiment, the force experienced by the IOL 212 is the radial expansion of the helical coil fastener 214 within the IOL left haptic foot cavity 226A.

[0112] exist Figure 3E In this configuration, the spiral coil fastener 214 is fully engaged with the IOL 212 and the iris 104. As shown, at least a portion of the spiral 236 of the spiral coil fastener 214 engages with the iris 104, and at least a portion of the IOL 212 (e.g., the bottom wall 228A of the left haptic member foot) is compressed and secured between the spiral coil fastener head 234 and the front surface of the iris 104. In this manner, the spiral coil fastener 214 is applied to each haptic member 218A, 218B to secure the IOL 212 to the iris 104. Additionally, as shown, the left haptic foot 224A of the IOL contacts the front surface of the iris 104, the first raised portion 220A of the left haptic foot arches the IOL optics 216 away from the iris 104, and the aperture 232A of the left haptic foot reduces the contact area of ​​the IOL 212 (and the left haptic 218A) relative to the front surface of the iris 104. The opening 230A of the left haptic foot further reduces the contact area of ​​the left haptic foot 224A relative to the front surface of the iris 104.

[0113] like Figure 4A As shown (and as above) Figures 2A-3E As shown, the haptic foot 424A includes an inner wall 425A that defines a closed cavity 426A (e.g., a hole, aperture, opening) extending downward from the front surface of the foot 424A. The closed cavity 426A may have a complete circumference. The foot 424A also includes a bottom wall 428A that extends inward from the inner wall 425A into the closed cavity 426A and is adjacent to or spaced apart from the rear surface of the foot 424A (e.g., to reduce the contact area between the haptic foot 424A and the iris 104). The bottom wall 428A may partially or completely close the closed cavity 426A. If the bottom wall 428A completely closes the closed cavity 426A (as in a blind hole), the helical coil fastener 214 must be inserted through the bottom wall 428A to secure the IOL to the iris 104. If the bottom wall 428A partially closes the enclosed cavity 426A, a portion of the periphery of the bottom wall 428A and a portion of the inner wall 425A defines an opening 430A extending upward from the rear surface of the foot 424A. A helical coil fastener 214 is positioned within the foot enclosed cavity 426A to secure the IOL to the iris 104. The helical coil fastener head 234 contacts the bottom wall 428A to compress the bottom wall 428A between the helical coil fastener head 234 and the front surface of the iris 104. Additionally, it is noteworthy that the helical coil fastener head 234 can be recessed and concealed within the tactile foot 424A such that at least a portion of the helical fastener head 234 does not extend beyond the front surface of the tactile foot 424A.

[0114] exist Figure 4B In the tactile element, the foot portion 424B includes an inner wall 425B that defines an open cavity 426B extending downward from the front surface of the foot 424B (with...). Figure 4A (Similarly). The inner wall 425B forms an arc (but not a closed circle), giving the open cavity 426B a partial circumference. This design reduces the profile and size of the IOL 212. Consequently, the reduced haptic coverage area also reduces the amount of contact area between the device's IOL 212 and the front surface of the iris 104.

[0115] exist Figure 4C In the middle, the tactile foot 424C includes an inner wall 425C defining a closed through-hole 426C (similar to...). Figure 4A (But without a bottom wall). This configuration can be used when the diameter of the helical coil fastener head 234 is larger than the diameter of the through hole 426C, such that the helical coil fastener head 234 contacts the rear surface of the haptic foot 424C to compress the haptic foot 424C between the helical coil fastener head 234 and the front surface of the iris 104. Alternatively, this configuration can be used when the diameter of the helix 236 is larger than the diameter of the through hole 426C (e.g., compression fit).

[0116] exist Figure 4D In the middle, the tactile foot portion 424D includes an inner wall 425D defining an open through hole 426D (similar to...). Figure 4B (But without a bottom wall). The haptic foot 424D will be similar to... Figure 4C Perform the operation.

[0117] exist Figure 4E In the middle, the tactile component foot 424E includes defining a closed through hole 426E (with Figure 4C The inner wall 425E (similar to the inner wall 425E) of the haptic foot 424E also includes a countersunk hole 400E, such that the spiral coil fastener head 234 is recessed within the haptic foot 424E when fully engaged with the iris 104, thereby providing a smaller profile and concealing the spiral coil fastener head 234 within the haptic foot 424E, such that at least a portion of the coil fastener head 234 does not extend beyond the front surface of the haptic foot 424E.

[0118] exist Figure 4F In the middle, the tactile foot 424F includes an inner wall 425F defining an open through hole 426F (similar to...). Figure 4D (The haptic element foot 424F also includes a countersunk hole 400F). The haptic element foot 424F will be similar to... Figure 4E Perform the operation.

[0119] exist Figure 4G In the middle, the tactile component foot 424G includes an inner wall 425G defining a closed through-hole 426G (similar to...). Figure 4CThe haptic foot 424G also includes a retaining pin 402G (e.g., a rod). The retaining pin 402G extends through a closed through-hole 426G (e.g., through the diameter of the through-hole 426G) and at least partially (but fully shown) through an inner wall 425G to mount the pin 402G within the closed through-hole 426G. One or both ends of the retaining pin 402G may include a cap 432G to prevent axial movement of the retaining pin 402G from the haptic foot 424G and potential accidental removal. The retaining pin 402G can be located anywhere between the front and rear surfaces of the haptic foot 424G, but is preferably oriented towards the front surface. The retaining pin 402G can be pre-loaded in the haptic foot 424G (along with the helical coil fastener 214), or it can be inserted after the IOL 212 is deposited within the eye 100. In use, the helical coil fastener 214 can be inserted into the closed through-hole 426G before or after the retaining pin 402G has been installed therein. Due to the spacing between the coil pitches of the helix 236, the helical coil fastener 214 can be translated through the closed through-hole 426G using the retaining pin 402G positioned therein. During the insertion of the helical coil fastener 214 into the front surface of the iris 104 and after translating at least a portion of the closed through-hole 426G, the head 234 of the helical coil fastener 214 finally contacts the retaining pin 402G, and the IOL 212 is mounted to the iris 104 by downwardly compressing the helical coil fastener head 434 against the top surface of the retaining pin 402G, which also delivers the haptic foot 424G downwardly compressed against the iris 104.

[0120] exist Figure 4H In the middle, the tactile element foot 424H includes an inner wall 425H defining an open through hole 426H (similar to...). Figure 4D (The tactile component 424H also includes a retaining pin 402H. The retaining pin 402H will be similar to...) Figure 4G Perform operations and may include, for example Figure 4G The cap 432H described in the document.

[0121] exist Figure 4I In the tactile element, the foot portion 424I includes an inner wall 425I that defines a closed through-hole 426I having a retaining pin 402I (e.g., a rod). Figure 4G Except that the end of the retaining pin 402I is held within the tactile foot 424I (e.g., the end of the retaining pin 402I extends at least partially (but may extend completely)) through the inner wall 425I to mount the retaining pin 402I outside the closed through hole 426I, the retaining pin 402I is similar to Figure 4G The 402G is maintained and put into operation.

[0122] exist Figure 4JIn the middle, the tactile foot portion 424J includes an inner wall 425J that defines an open through hole 426J with a retaining pin 402J (similar to...). Figure 4I (The pin 402J will be similar to...) Figure 4G Perform the operation.

[0123] In relation to Figures 4A-4H In each of the embodiments discussed, the cavity can be a straight or angled aperture. More specifically, for a straight aperture, the cavity can be configured perpendicular to the rear surface of the haptic element or an axis perpendicular to it. In some embodiments, it may be advantageous for the cavity to be slightly angled (e.g., tilted) relative to the rear surface of the haptic element—such as angled toward the pupil 128 (or the periphery of the iris).

[0124] Figures 5A-5D This is a view of another embodiment of an intraocular implant assembly incorporating a spacer ring. (See image) Figure 5A As shown, the double-flange washer 500A includes an upper flange 502A (e.g., a first flange), a lower flange 504A (e.g., a second flange), and a shaft 506A therebetween, the upper flange 502A, the lower flange 504A, and the shaft 506A defining a channel 508A. A tactile element 518 is shown, including a foot 524 with an inner wall 525 defining a cavity 526. The double-flange washer 500A is pre-loaded into the tactile element 518 such that the upper flange 502A is close to the front surface of the foot 524 of the tactile element, the lower flange 504A is close to the rear surface of the foot 524 of the tactile element, and the shaft 506A is positioned within the foot 526 of the tactile element. When the diameters of the upper flange 502A and the lower flange 504A are larger than the tactile foot cavity 226, the double flange annular gasket 500A is fixed relative to the tactile foot 224.

[0125] The incorporation of the bi-flange pad 500A can offer several benefits during the fabrication of intraocular implant components, as this component can be added to the IOL after tumbling and polishing (e.g., as a final assembly step), which can occur after the optics have been turned or molded (e.g., after the precision and polishing of the IOL optics). During tumbling and polishing of the IOL, sharp and rough lens surfaces are removed. Therefore, mechanical pawls, grooves, ridges, protrusions, and other mechanical features may be unintentionally altered or removed, or their dimensions may become uncontrollable. As an auxiliary operation in the fabrication process, inserting the bi-flange pad 500A, which has such mechanical features (e.g., on the bottom surface of the lower flange 504A), into the tactile foot cavity 226 ensures that the mechanical features are preserved without affecting the quality of the optical surface. Therefore, the optical surface itself will need to be protected during the pad manufacturing step to avoid affecting the quality of the lens surface. The bi-flange pad 500A or other pads can be added to tactile hole constructions employing partial circumference—for example, as discussed above. Figure 4C and Figure 4F As shown, pad rings 500A and 500B are inserted through a portion of the circumference to create a mechanical interference fit and attach to the tactile element.

[0126] like Figure 5B As shown, the single-flange washer 500B comprises only an upper flange 502B and a shaft 506B extending downward therefrom (without a lower flange), the upper flange 502B and the shaft 506B defining a channel 508B. After the IOL 212 is inserted into the anterior chamber 110 of the eye 100, the single-flange washer 500B can be inserted into the foot cavity of the haptic device. This provides structural rigidity to the haptic device and provides a simpler and more reliable connection between the helical coil fastener 214 and the iris 104.

[0127] like Figure 5C and Figure 5D As shown, the single-flange washer 500B can receive the helical coil fastener 214 and serve as a receiving mechanism for the helical coil fastener 214. The helical coil fastener 214 includes a head 234, a helix 236, and a tip 238, as described above. Figure 2EAs described above, the helical coil fastener 214 can be housed within a single-flange washer 500B. The helical coil fastener 214 can be pre-loaded (e.g., before insertion into the eye) or installed after the IOL 212 is inserted into the eye 100. The single-flange washer 500B and the helical coil fastener 214 will serve as nuts and bolts within the tactile element. The advantage of pre-loading the helical coil fastener 214 is that it is safely housed, eliminating the risk of accidental damage to the iris 104 (e.g., scratches, cuts, etc.) or to the IOL 212 (e.g., during insertion of a folded intraocular lens). In this way, to remove the helical coil fastener 214 from the iris, the helical coil fastener 214 is simply rotated in the opposite direction to translate the helical coil fastener back into the washer 500A, 500B in a retraction orientation. The single-flange washer 500B and helical coil fastener 214 contained therein can then be removed, thereby minimizing the risk of accidental eye injury 100 or IOL 212.

[0128] like Figure 5C As shown, the helical coil fastener 214 is held within the single-flange washer 500B in a retracted orientation, and its internal thread and the helical coil fastener 214 are at a first pitch. The single-flange washer 500B may include an internal thread that serves as a mating element for the pitch of the helical coil fastener 214. The thread pitch may have an exit or outlet that separates the pitch of the helical coil fastener 214 when it enters the iris tissue. Once inside the tissue, the pitch of the helical coil fastener 214 will return to its natural state, which will be a tighter pitch. Therefore, in practice, once screwed into the iris tissue, the helical coil fastener 214 will tighten once it leaves the IOL 212 and is guided into the tissue.

[0129] The single-flange washer 500B may include grooves, ridges, or mechanical features and protrusions, providing a surface for coil residence and also serving as a mechanical pawl to prevent excessive intrusion of the helical coil fastener 214 into the iris tissue. The rear surface of the single-flange washer 500B may include ridges, dots, protrusions, or protrusions to minimize surface contact between the washer 500A, 500B and the iris tissue.

[0130] As the helical coil fastener rotates and traverses the single-flange washer channel 508B (or alternatively, the threaded tactile foot cavity 226), the internal pitch threads separate the pitch of the helical coil fastener 214 (as illustrated by the distance X, representing the distance between the turns of the helical coil fastener 214). This, in turn, opens the helical coil fastener 214 to allow the tip 238 of the helical coil fastener 214 to penetrate the iris tissue at a deeper, more pronounced, or perpendicular angle.

[0131] As Figure 5D shown in Figure 5D , when the helical coil fastener 214 rotates and translates (e.g., translates internally) within the single flange grommet 500B, the helical coil fastener 214 also rotates and translates into the iris 104. Additionally, when the helical coil fastener 214 exits the single flange grommet 500B and penetrates into the iris 104, the pitch of the helical coil fastener 214 changes (e.g., decreases). Thus, the helical coil fastener 214 extends into the iris 104 in an extended orientation, with at least a portion of the head 234 and / or the helix 236 engaging at least a portion of the internal threads of the single flange grommet 500B to secure the single flange grommet 500B to the iris 104, and securing the haptic foot between the upper flange 502B and the front surface of the iris 104.

[0132] Furthermore, once the helical coil fastener 214 is in place within the iris tissue, the pitch of the spring coil returns to its natural state (as illustrated by the distance <X), returning to a more tightly wound coil with a smaller separation between the coil pitches to create a greater apposition of the IOL 212 to the iris tissue (e.g., its front surface). Additionally or alternatively, to achieve this self - tightening, the helical coil fastener 214 can be made of a shape - memory material that changes pitch in response to body temperature or an externally applied energy source (such as resistive heating, applied current, laser emission, etc.).

[0133] Alternatively, the lead - thread pitch at the exit or outlet of the IOL 212 can place the distal end of the helical coil fastener 214 at a more oblique angle to penetrate the iris tissue minimally. Once inserted into the iris tissue, the helical coil fastener 214 will return to its natural pitch, such that the separation between the pitches is slightly greater.

[0134] As yet another alternative (or addition), the haptic foot cavity can be constructed with a mechanical pawl to guide the helical coil fastener tip 238 backward or downward into the iris tissue. As described above, once inside the iris tissue, the helical coil fastener 214 returns to its natural pitched configuration to sweep through the area for holding the IOL 212 in place.

[0135] In another embodiment, after the helical coil fastener 214 is fully engaged with the iris tissue, the single flange grommet 500B independently advances the helical coil fastener 214 backward. In this way, the IOL 212 can be retracted from the front surface of the iris 104 to a predetermined distance.

[0136] Although shown with respect to the single flange grommet 500B Figure 5C and Figure 5DHowever, this description can also be applied to the bi-flange retainer 500A. Furthermore, for the bi-flange retainer 500A, the bi-flange retainer 500A and the spiral coil fastener 214 can be inserted into the tactile element of the IOL 212, which has been tumbled and polished, in preparation for final assembly. During the implantation process, the spiral coil fastener 214 and the bi-flange retainer 500A can be integral and pre-placed on the tactile element of the IOL. Once inserted and positioned on the patient's iris 104, the spiral coil fastener 214 is pre-placed and ready for insertion into the iris 104.

[0137] Figure 6 This is a side view of a spiral coil fastener 214 having a protective gasket 600 for controlling and limiting the insertion depth of the spiral coil fastener 214. The protective gasket 600 can be used with the above... Figures 2A-2G The IOL 212 discussed above, along with a portion of the IOL component 210, are used together. (As mentioned above...) Figures 2E-2G As described, the helical coil fastener 214 includes a head 234, a helix 236, and a tip 238. A protective pad 600 prevents the tip 238 from advancing further into the iris tissue and prevents the tip 238 from penetrating or advancing too far into the iris tissue (e.g., the posterior surface of the iris tissue contains vulnerable muscle tissue that is to be avoided). Alternatively, the depth of penetration can be limited by a mechanical pawl interacting with the helical coil fastener head 234 or any location on the helical coil fastener 214, and a corresponding mechanical stop within the IOL 212, or by a separate washer ring in the IOL haptic foot 226.

[0138] Figure 7 This is a top perspective view of another embodiment of a spiral coil fastener 714 for attaching the IOL 212 of the IOL assembly 210 to the iris 104. The spiral coil fastener 714 can be used with the IOL 212 and can be the above. Figures 2A-2G This is part of the IOL component 210 discussed above. Figures 2E-2G As described herein, the helical coil fastener 714 includes a head 734, a helix 736, and a tip 738—except that the head 734 includes the tip of the helix 736 extending beyond the outer diameter of the helix 736. The head 734 may extend from a first side of the helix through the helix (e.g., the diameter of the helix) to a second side of the helix and beyond the second side of the helix. Insertion of the helical coil fastener 714 stops when the head 734 (e.g., the tip of the helix) contacts the front surface of the IOL 212.

[0139] Figure 8This is a top perspective view of another embodiment of a spiral coil fastener 814 for attaching the IOL 212 of the IOL assembly 210 to the iris 104. The spiral coil fastener 814 can be used with the IOL 212 and can be the above. Figures 2A-2G This is part of the IOL component 210 discussed above. Figures 2E-2G As described, the helical coil fastener 814 includes a head 834, a helix 836, and a tip 838, except that the head 834 includes a plurality of circumferentially spaced notches 800 and circular recesses 802 in its top surface. The fastener applicator tool 870 includes a first shaft 872 and a second shaft 874 perpendicular to the first shaft 872. A cylindrical, axially rotatable rotating mechanism 804 has a plane 806 at its end, which has a plurality of protrusions 880 extending from the plane 878. The rotating mechanism 804 rotates about the first shaft 872 and is axially aligned with the first shaft 872 such that the plurality of protrusions 808 approach the second shaft 874. In this way, when the distal end of the second shaft 874 engages the circular recesses 802 of the helical coil fastener 814, at least one of the plurality of protrusions 808 engages with at least one of the plurality of circumferentially spaced notches 800. Therefore, when the rotating mechanism 804 rotates, the plurality of protrusions 808 engage and disengage from the plurality of circumferentially spaced recesses 800, causing the helical coil fastener 814 to rotate about the second shaft 874 of the fastener applicator tool 870.

[0140] Figure 9 This is a side view of another embodiment of a spiral coil fastener 914 for attaching an IOL 212 to an iris 104. The spiral coil fastener 914 can be used with the IOL 212 and can be the above... Figures 2A-2E This is part of the IOL component 210 discussed above. Figures 2E-2G As described, in addition to the helix 936 including one or more grooves 900 extending axially along the helix 936, the helical coil fastener 914 includes a head 934, a helix 936, and a tip 938. The one or more grooves 900 (e.g., ridges, lines, etc.) provide mechanical support for the helical coil fastener 914 in the iris tissue without affecting insertion and can be created by etching. The one or more grooves 900 may be circumferentially spaced around the axis of the helix 936. The one or more grooves 900 increase the surface area of ​​the helical coil fastener 914 and its contact area with the iris tissue while reducing the cross-sectional area of ​​insertion and without hindering the insertion or removal of the helical coil fastener 914 from the iris tissue. The one or more grooves 900 may be spaced apart for tissue interaction or where tissue may reside to improve the upward or downward stability of the IOL 212 in the iris tissue.

[0141] Figure 10 This is a side view of another embodiment of a spiral coil fastener 1014 for attaching an IOL 212 to an iris 104. The spiral coil fastener 1014 can be used with the IOL 212 and can be the above... Figures 2A-2G This is part of the IOL component 210 discussed above. Figures 2E-2G As described, the helical coil fastener 1014 includes a head 1034, a helix 1036, and a tip 1038, except that the tip 1038 is angled upwards. More specifically, the helical coil fastener 1014 enters the iris tissue at an acute angle. Once screwed into the iris tissue, the pre-formed tip 1038 (and / or coil pitch) can be rotated to bend upwards back to the anterior surface of the iris (e.g., the posterior surface of IOL 212).

[0142] Figure 11 This is a perspective view of a digital fastener applicator tool 1170 used to apply a helical coil fastener 214 to the iris 104 to attach the IOL 212 to the iris 104. The digital fastener applicator tool 1170 can be used with the above... Figures 2A-10 Used with any fasteners and / or IOL components discussed herein. As Figures 3C-3E Like a conventional fastener applicator tool, the digital fastener applicator tool 1170 includes a first sleeve 1172 and a second sleeve 1174 extending further from and substantially perpendicular to the first sleeve 1172. The second sleeve 1174 includes a distal opening 1176. The distal opening 1176 may be circular or round in shape at the distal opening, but other shapes including non-circular and / or straight edges, such as polygonal openings like hexagonal openings, are also possible. For a hexagonal distal opening, the tactile hole or front surface of the washer ring will have a similar non-circular shape, such as a hexagonal shape, to mate or engage the distal opening of the digital fastener applicator tool with or engage the tactile hole. When the helical coil is screwed into the iris tissue, the non-circular or polygonal engagement will further stabilize the tactile element and lens. Furthermore, the digital fastener applicator tool 1170 includes a handle portion 1100 extending from the proximal end of the first sleeve 1172. The digital fastener applicator tool 1170 includes a digital button for actuating operation of the digital fastener applicator tool 1170, such as for rotating the helical coil fastener 214 to be at least partially contained within the distal opening 1176. As shown, the handle portion 1100 is configured to be positioned and compressed between the thumb and fingers (e.g., where further compression of the button actuates the digital fastener applicator tool 1170).

[0143] The digital fastener applicator tool 1170 may include feedback from a force-sensing mechanism. When the helical coil fastener 214 is engaged or secured into the iris tissue, the force-sensing mechanism may be designed to have a torque meter for providing feedback to the surgeon. The force-sensing mechanism may also have markers providing external feedback to the surgeon. The force-sensing mechanism may also be connected to an audible tone or signal to indicate to the physician when the rotation of the helical coil fastener 214 is complete or within specifications. Alternatively, the digital fastener applicator tool 1170 may be limited to only a certain number of rotations, which limits the penetration amount of the helical coil fastener 214 into the iris tissue.

[0144] Figure 12 This is a perspective view of a mechanical fastener applicator tool 1270 used to apply a helical coil fastener 214 to the iris 104 to attach the IOL 212 to the iris 104. The digital fastener applicator tool 1270 can be used with the above... Figures 2A-10 Used with any fasteners and / or IOL components discussed herein. As Figures 3C-3E and Figure 11 Like a conventional fastener applicator tool, the mechanical fastener applicator tool 1270 includes a first sleeve 1272 and a second sleeve 1274 extending further from and substantially perpendicular to the first sleeve 1272. The second sleeve includes a distal opening 1276. Furthermore, the mechanical fastener applicator tool 1270 includes a handle portion 1200 extending from the proximal end of the first sleeve 1272. The bottom surface of the handle portion 1200 includes ergonomic contours 1202 (e.g., notches, grips, knurling, etc.) for a surgeon to hold (e.g., for engaging the surgeon's fingertips, palm, or thumb). The top surface of the handle portion 1200 includes a mechanical actuator 1204 (e.g., a wheel) for manual rotation by the surgeon's fingers or thumb. Rotation of the mechanical actuator 1204 can actuate the operation of the digital fastener applicator tool 1270, such as to rotate a helical coil fastener 214 to be at least partially contained within the distal opening 1276. The mechanical actuator 1204 is manually rotated to operate the cable, which in turn rotates the drive to screw the helical coil fastener 214 into the iris 104. Additionally, the handle portion 1200 may include a mark or other indicator for the number of rotations made by the helical coil fastener 214. This can be measured; the more coils of the helical coil fastener 214 inserted into the iris tissue, the greater the juxtaposition within the iris tissue.

[0145] The description and features of the handle portions 1100 and 1200 of the digital fastener applicator tool 1170 and the mechanical fastener applicator tool 1270 are interchangeable. For both the digital fastener applicator tool 1170 and the mechanical fastener applicator tool 1270, the handle portions 1100 and 1200 are symmetrical about a central axis (e.g., for right-handed and left-handed positioning). The handle portions 1100 and 1200 are balanced, lightweight, constructed to fit in the hand and be manipulated by the fingers, and may include elongated distal portions with small profiles for working in small-diameter spaces. The fact that the handle portions 1100 and 1200 are balanced and easy for a physician to grip facilitates control of the position of the distal openings 1176 and 1276 within the anterior chamber 110 of the eye 100. The handle portions 1100 and 1200 may also be disposable or reusable. The actuators of the fastener applicator tools 1170 and 1270 are configured to rotate and / or translate the helical coil fastener 214 into the iris 104.

[0146] Figure 13 This is a perspective view of the spindle 1300 and the rotary cam 1302, which can be used for... Figure 11 and / or Figure 12 One or more helical coil fasteners 214 are rotated and / or translated through fastener applicator tools 1170 and 1270. Rotary cam 1302 and mandrel 1300 can be used with the above... Figures 2A-10 This applies to any fasteners and / or IOL components and / or fastener applicator tools 1170, 1270 discussed herein. Specifically, the rotating mandrel 1300 defines a central bore through which one or more helical coil fasteners 214 can pass. Furthermore, the rotating cam 1302 and mandrel 1300 can be used with respect to the vertical orientation of the first sleeves 1172, 1272 relative to the second sleeves 1174, 1274. Rotation of the mandrel 1300 can be achieved by one or more cams 1302 that mechanically engage to rotate the distal ends of the fastener applicator tools 1170, 1270.

[0147] Figures 14A-14C This is a view of a digital fastener applicator tool 1470 used to apply a helical coil fastener 214 to the iris 104 to attach the IOL 212 to the iris 104. The digital fastener applicator tool 1470 can be used with the above... Figures 2A-10 Used with any fasteners and / or IOL components discussed herein, and / or may include information regarding Figure 11 and Figure 12 Fastener applicator tools 1170, 1270 and / or Figure 13The rotary cam 1302 and mandrel 1300 are one or more of the features discussed. Although the digital fastener applicator tool 1470 has been discussed, the described features can also be applied to mechanical fastener applicator tools. As above in Figure 11 and Figure 12 Like the fastener applicator tools discussed above, the digital fastener applicator tool 1470 includes a first sleeve 1472 and a second sleeve 1474 that is further than the first sleeve 1472 and is substantially perpendicular to (or angled relative to) the first sleeve 1472 at a bend 1402. As discussed above, the angled orientation of the first sleeve 1472 and the second sleeve 1474 allows the distal end of the digital fastener applicator tool 1470 to be inserted through a cut 300 in the eye 100 and then rotated to position the distal opening 1476 in the second sleeve 1474 to engage with the IOL haptic element 218. The first sleeve 1472 and / or the second sleeve 1474 may include internal threads 1406 (or other ridges, ridges, and / or threads) to guide one or more helical coil fasteners 1414 through and out of the digital fastener applicator tool 1470.

[0148] The helical coil fastener 1414 can be pre-loaded into the handle portion 1400, the first sleeve 1472, or the second sleeve 1474. Thus, for example, two or more helical coil fasteners 1414 can be pre-loaded into each haptic element 218 and / or each IOL 212. The helical coil fastener 1414 can be loaded into the digital fastener applicator tool 1470 by a surgeon during use. Alternatively, the helical coil fastener 1414 can be picked up by the distal end of the digital fastener applicator tool 1470 (e.g., through the actuator 1496 of the distal opening 1476). For some configurations of the helical coil fastener 1414, it may be advantageous for the surgeon to load the coil onto the instrument.

[0149] For helical coil fasteners 1414 made of shape memory materials (e.g., nitinol), reducing the amount of time the coil is under stress during sterilization, transportation, and shelf life can improve the overall fatigue and durability of helical coil fasteners 1414.

[0150] Furthermore, the digital fastener applicator tool 1470 includes a handle portion 1400 extending from the proximal end of the first sleeve 1472. The top surface of the handle portion 1400 includes a digital actuator 1404 (e.g., a finger button) that is easily accessible. The bottom surface of the handle portion 1400 may be shaped (e.g., including a handle) for gripping and holding the digital fastener applicator tool 1470.

[0151] At the proximal end of the handle portion 1400 is a battery 1408, which is mechanically and electrically connected to the motor 1410, such as at the proximal end of the motor 1410 (e.g., via connecting wire 1412). The battery 1408 is rechargeable through a port in the handle portion 1400. A motor switch 1416 of the motor 1410 is located near a digital actuator 1404, such that pressing the digital actuator 1404 activates the motor switch 1416 to activate the motor 1410.

[0152] The distal end of motor 1410 includes a drive cylinder 1418, wherein operation of motor 1410 causes drive cylinder 1418 to rotate. Drive cylinder 1418 is mechanically connected (e.g., mechanically coupled) at its proximal end to rotary cable 1420. The distal end of rotary cable 1420 includes a driver 1496. Rotary cable 1420 extends into a first sleeve 1472 and a second sleeve 1474, and is extendable / retractable through the first sleeve 1472 and the second sleeve 1474 beyond handle portion 1400. In other words, as driver 1496 translates through the first sleeve 1472 and / or the second sleeve 1474, rotary cable 1420 can extend and / or stretch to maintain the physical connection between driver 1496 and motor 1410.

[0153] like Figure 14AAs shown, the actuator 1496 is physically connected to one of a plurality of helical coil fasteners 1414 located within the first sleeve 1472 and the second sleeve 1474 (e.g., via magnetic connection, physical engagement, etc.). The two helical coil fasteners 1414 are adjacent to each other (e.g., directly behind each other). When a user (e.g., a doctor, surgeon, etc.) presses down the digital actuator 1404, the digital actuator 1404 activates the motor switch 1416, which in turn activates the motor 1410. The motor 1410 then rotates the drive cylinder 1418, which rotates the rotating cable 1420, which in turn rotates the actuator 1496. As the actuator 1496 rotates, it translates through the internal thread 1406 via the first sleeve 1472 and / or the second sleeve 1474. As the actuator 1496 rotates and / or translates through the first sleeve 1472 and / or the second sleeve 1474, the actuator 1496 rotates and / or translates one or more helical coil fasteners 1414 connected (e.g., mechanically engaged) to the actuator 1496, providing rotational energy to the helical coil fasteners 1414. In this way, rotating the first helical coil fastener 1414 connected to the actuator 1496 can subsequently rotate a second helical coil fastener 1414 mechanically in communication with the first helical coil fastener 1414. The actuator 1496 rotates and / or translates the helical coil fasteners 1414 until at least a portion of one of the helical coil fasteners 1414 exits the digital fastener applicator tool 1470. Once the helical coil fastener 1414 is inserted into the iris tissue, the actuator 1496 disengages from the helical coil fastener 1414. Alternatively or additionally, the distal end of the fastener applicator tool 1470 includes an engagement and rotation mechanism for cooperating with the helical coil fastener 1414.

[0154] Figure 14B The diagram illustrates a straight orientation. Figure 14A A side view of the distal end of the second sleeve 1474 of the digital fastener applicator tool 1470. As shown, the second sleeve 1474 is axially aligned with the first sleeve 1472, forming a linear angle relative to each other. This reduces the insertion profile of the second sleeve 1474 into the eye 100.

[0155] Figure 14C The diagram illustrates objects in a curved orientation that form a nonlinear angle with respect to each other. Figure 14AA side view of the distal end of the second sleeve 1474 of the digital fastener applicator tool 1470. Once inserted into the eye 100, the second sleeve 1474 can be bent along the bend 1402 such that the second sleeve 1474 is perpendicular or angled relative to the first sleeve 1472. This facilitates the surgeon's use of the digital fastener applicator tool 1470. The hinge of the distal tip of the digital fastener applicator tool 1470 can be accomplished by pulling or twisting the sleeve attached to the bendable portion at the distal end. In this way, the distal end of the digital fastener applicator tool 1470 can be movable, but alternatively, the distal end can be fixed and shaped into an angled bend (e.g., 45 degrees, 90 degrees, etc.).

[0156] Figure 15 This is a cross-sectional side view of a digital fastener applicator tool 1570, which attaches a helical coil fastener 1514 (or any other type of fastener and / or anchor) from outside the eye 100 via an external heat source. More specifically, if the helical coil fastener 1514 is made of a thermochromic material (e.g., nitinol), then from outside the eye 100, the fastener applicator tool 1570 emits a laser 1500 (or other heat source or electrical probe) through the cornea 102 to heat the helical coil fastener 1514 from outside the eye 100. The applied heat causes the helical coil fastener 1514 to rotate and / or penetrate the iris 104. Alternatively, the heat source can be applied by direct contact with the instrument.

[0157] Alternatively or additionally, when a known amount of heat exposure (e.g., body temperature), current (e.g., from the body), and / or a higher temperature or current is applied from the instrument and / or fastener applicator tool 1570, the thermochromic material can react and change shape. Once exposed to a higher temperature or current, the nitinol form can change shape or untangle or rotate. In this example, the helical coil fastener 1514 will rotate to screw into the iris 104 without any applied external mechanical force, and the rotational energy will be supplied by the coil material itself.

[0158] In another embodiment, stored energy or spring action can be supplied to the helical coil fastener 1514, and the spring action is released once the IOL 212 is positioned on the iris 104. The helical coil fastener 1514 will then be screwed into the iris by the rotational force provided by the known and predetermined spring action of the coil material. Mechanical release will provide rotational force for the tightening action.

[0159] Alternatively, the helical coil fastener 1514 can be made of a ferromagnetic material capable of responding to a supplied magnetic field or magnetic source. In this example, exposure to a magnetic field causes the coil to rotate and screw into the iris. Advantageously, the magnetic field can be provided from a location immediately adjacent to the IOL 212 (e.g., supplied by an instrument within the eye) or from a magnetic field applied externally to the eye, and the magnetic field can be made to respond to the ferromagnetic coil material.

[0160] The attachment of the IOL 212 to the iris 104 can also be accomplished using an intraocular suturing system. This system provides a curved needle to pierce the iris 104 and pass the suture through it to the IOL 212. Once pulled past the locking ring, excess suture can be cut and removed.

[0161] Figures 16A-16C This is a view of another embodiment of an intraocular implant assembly that uses anchors to attach the IOL 212 of the IOL assembly 210 to the iris 104. Figure 16A The image shows the foot of the intraocular implant (IOL) tactile component, along with screw fastener 1614 and applicator tool 1670. Screw fastener 1614 can be used with the above-mentioned... Figures 2A-2G This can be used with any IOL components discussed herein. As shown, the screw fastener 1614 includes a cylindrical head 1634 having an engagement hole 1600 located at the top surface of a cylindrical head 1634 and a threaded shaft 1636 having a tip 1638. The applicator tool 1670 includes a friction drive wheel 1672 extending from the distal end of the applicator tool 1670. The applicator tool 1670 also includes a protrusion 1674 adjacent to and positioned away from the friction drive wheel 1672. The protrusion 1674 is sized and shaped to engage the screw fastener engagement hole 1600. The protrusion 1674 and the friction drive wheel 1672 are spaced apart such that when the protrusion 1674 engages the threaded fastener engagement hole 1600, the friction drive wheel 1672 contacts the outer surface of the cylindrical head 1634 of the threaded fastener. Therefore, as the friction drive wheel 1672 rotates in the first direction, the cylindrical head 1634 rotates about the engagement hole 1600 in a second direction opposite to the first direction. During the insertion of the screw fastener 1614, the applicator tool protrusion 1674 stabilizes the screw fastener 1614, provides a point of rotation for the screw fastener 1614, and ensures that the screw fastener head 1634 contacts the friction drive wheel 1672.

[0162] Figure 16B and Figure 16C Is with Figure 16AA view of the anchor used in conjunction with the screw fastener 1614. Once the IOL 212 is inserted into the eye, the anchor 1602 (e.g., similar to a schist anchor or a molly bolt anchor) can be used to attach the IOL 212, wherein the IOL 212 is then easily attached to the iris 104 using the anchor 1602. The anchor 1602 can be used with the above-mentioned... Figures 2A-2G Use with any IOL components discussed in the document.

[0163] Figure 16B This is a perspective view of an anchor 1602 in an open orientation, which can be used with a screw fastener 1614. The anchor 1602 includes a tip 1604 and one or more circumferentially spaced flaps 1606, each flap 1606 including a stabilizing feature on its bottom surface to engage the front surface of the iris 104. The anchor 1602 helps orient the tip 1638 of the screw fastener 1614 and reduces the amount of axial force required for the screw fastener 1614 to penetrate the iris 104. In this way, the stabilizing feature of the flaps 1606 prevents axial rotation of the anchor 1602.

[0164] Figure 16C It is in a closed orientation after the screw fastener 1614 has been inserted into the anchor 1602 and the iris 104. Figure 16B A perspective view of the anchor 1602. In this manner, when the anchor 1602 and the screw fastener 1614 are inserted into the iris 104, the flap 1606 of the anchor 1602 folds upward. The flap 1606 of the anchor 1602 can be biased towards an open orientation to increase stability and security within the iris 104. If the screw fastener 1614 is removed, the anchor 1602 can block light and remain within the iris 104.

[0165] Alternatively, the anchor 1602 can be initially inserted in a closed orientation, such that the screw fastener 1614 and the anchor 1602 penetrate the iris, with the anchor 1602 in a closed orientation. Once inserted, the anchor 1602 then changes to an open orientation, thereby securing the anchor 1602 and the screw fastener 1614 (mechanically attached to the anchor 1602) within the iris 104. In either case, the anchor 1602 can be activated by using a screw and / or a push-pull mechanism to change from a closed orientation to an open orientation (and / or vice versa).

[0166] Figure 17 This is a perspective view of an IOL assembly 1710 having an integrated thumbtack fastener 1714 for attaching the IOL assembly 1710 to the iris 104. The IOL assembly 1710 includes the components described above. Figures 2A-3EAll components discussed, except that each haptic element 1718 of IOL1712 includes a single raised portion 1720, and the haptic element foot 1724 includes an integrated flathead pin 1714 (e.g., a pin) instead of a spiral coil fastener, are included. Each integrated flathead pin 1714 includes a head 1734 and a shaft 1736 with a pointed tip 1738. The pointed tip 1738 can be bent relative to the shaft 1736 for easy insertion. More specifically, the head 1734 of each flathead pin 1714 is within the haptic element foot 1724, wherein a portion of the shaft 1736 and the pointed tip 1738 protrude from the bottom surface of the haptic element foot 1724. Before insertion, a protective cap 1700 is attached to the underside of the tactile foot 1724 to surround the tip 1738 of the flathead nail 1714 to prevent accidental damage to the IOL 1712 and / or iris 104 during folding, insertion, and / or removal. More specifically, once the IOL 1712 is in place and properly positioned, the cap 1700 can be removed with a tool, thereby exposing the tip 1738 of the flathead nail. This can be a two-handed technique, with one hand used to hold the IOL 1712 and the other hand used to remove the cap 1700. The IOL 1712 can then be pushed down with a paddle to secure the IOL relative to the iris 104. Alternatively, a removal tool including the cap can be requested to remove the IOL 1712 from the eye 100 to protect the iris 104 from the flathead nail 1714.

[0167] Figure 18 This is a perspective view of a closed channel within the tactile foot 1824 of an IOL assembly, having vertical hook fasteners positioned within the tactile foot for attaching the IOL assembly 1710 to the iris 104. The IOL assembly 1810 includes the above-mentioned... Figures 2A-3EAll components discussed, except that each haptic element 1818 of the IOL 1812 includes a single lifting portion 1820, and the haptic element foot 1824 is hollowed out to define a closed channel 1826 with a vertical hook fastener 1814 instead of using a spiral coil fastener. More specifically, the haptic element foot 1824 defines a closed channel 1826 perpendicular to the haptic element lifting portion 1820. The vertical hook fastener 1814 includes a shaft 1834 with a female thread 1800 at a first end and a hook 1836 with a point 1838 at a second end (opposite to the first end). The hook 1836 is oriented perpendicular to the shaft 1834 such that rotation about the axis of the shaft 1834 engages the hook 1836 with the front surface of the iris 104, thereby securing the IOL 1812 to the iris 104. A vertical hook fastener 1814 can be pre-loaded into the closed channel 1826 of the haptic foot, wherein the tip 1838 of the vertical hook fastener 1814 is securely positioned within the haptic foot 1824. An insertion tool can then be screwed into and inserted into the female thread 1800 of the vertical hook fastener 1814 to engage the vertical hook fastener 1814 and rotate it about its axis. The rotational force pushes the hook tip 1838 across the bottom surface of the haptic foot 1824 and into the iris 104 (or the IOL 1812 can be squeezed to disengage the hook 1836 from the haptic foot 1824). Alternatively, the female thread 1800 can be modified to receive an insertion tool of a corresponding shape. For example, the vertical hook fastener 1814 may include a suitable or hexagonal channel to receive an insertion tool of a corresponding shape.

[0168] Figure 19 This is a perspective view of the open channel 1926 in the tactile foot portion 1924 of the IOL assembly 1910, which has a vertical hook fastener 1914 positioned within the open channel 1926 for attaching the IOL 1912 to the iris 104. The IOL assembly 1910 includes the above-mentioned... Figures 2A-3E All components discussed, except that each haptic element 1918 of the IOL 1912 includes a haptic element lifting portion 1920, and a haptic element foot 1924 defines an open channel 1926 and a rotary hook fastener 1914 positioned therein instead of a helical coil fastener, are included. The open channel 1926 is perpendicular to the haptic element lifting portion 1920 but has an open top. The rotary hook fastener 1914 includes a shaft 1934 with a vertical hook 1936 extending from one end, the vertical hook including a point 1938. Thus, the rotary hook fastener 1914 can be placed in the open channel 1926, and once positioned in the open channel 1926, the rotary hook fastener 1914 can be rotated such that the point 1938 penetrates and engages the iris 104, thereby securing the IOL 1912 to the iris 104.

[0169] Figure 20 This is a side view of a fishhook fastener used to attach the IOL 1912 to the iris 104. The IOL assembly includes the components described above. Figures 2A-3E and Figure 19 All components discussed, including the haptic foot 2024, include an open channel 2025—except for the inclusion of a fishhook fastener 2014 instead of a spiral coil fastener. The fishhook fastener 2014 is inserted into the iris 104 such that the tip 2038 of the hook 2036 penetrates the iris 104, and the shaft 2034 of the fishhook fastener 2014 presses against the open channel 2025, thereby securing the IOL 1912 to the iris 104. More specifically, the fishhook fastener 2014 penetrates the iris 104, and then the shaft 2034 rotates about the hook 2036 to its final position.

[0170] Figure 21A This is a side view of the thumbtack fastener 2114 used to attach the IOL 1912 to the iris 104. The IOL assembly includes the components described above. Figures 2A-3E and Figure 19 All components discussed, including the tactile foot 2124, include an open channel 2125—except for the tack fastener 2114. The tack fastener 2114 includes a pointed tip 2138 at a first end and an externally threaded end 2100 (opposite to the first end). The tack fastener 2114 has a straight portion 2134 (near the externally threaded end 2100) and a curved portion 2136 near the pointed tip 2138. The straight portion 2134 is angled relative to the curved portion 2136. The threaded end 2100 is used for insertion and removal of both.

[0171] Figure 21B It is used for attachment Figure 21A A perspective view of a fastener applicator tool 2170 for a thumbtack fastener 2114. The fastener applicator tool 2170 includes an internally threaded end 2176 to engage the threaded end 2100 of the thumbtack fastener 2114. The applicator tool 2170 can be used to insert and rotate the thumbtack fastener 2114 to penetrate the iris tissue and secure the tip 2138 of the thumbtack fastener 2114 within the iris 104. The straight portion 2134 of the thumbtack fastener 2114 is then positioned within an open channel 2125, securing the IOL 2112 to the iris 104. The threaded end 2100 may extend beyond one end of the open channel 2125, allowing the fastener applicator tool 2170 to access the threaded end 2100 for removal.

[0172] Figure 22AThis is a perspective view of a spring clip fastener 2214 for attaching an IOL to an iris 104. The spring clip fastener 2214 includes a generally U-shaped clip 2234 having a first tip 2238 extending outward from a first end and a second tip 2238 extending outward from a second end (opposite to the first end). The first and second tips 2238 extend away from each other. In this way, the spring clip fastener 2214 can be clamped (bringing the first and second tips 2238 closer together) and inserted into the iris 104 when clamped. Releasing the spring clip fastener 2214 in a position adjacent to the iris 104 helps push the spring clip fastener 2214 into the iris 104.

[0173] Figure 22B It is located above the IOL tactile component 2218 of the intraocular implant assembly 2210, above the IOL tactile component lifting portion 2220. Figure 22A A perspective view of the spring clip fastener 2214, with an enlarged foot 2224 (wider than the haptic lifting portion 2220) preventing the IOL 2212 from disengaging from the spring clip fastener 2214. After the spring clip fastener 2214 has been positioned in the iris 104, the haptic foot 2224 can be pushed through the spring clip fastener 2214. Alternatively, the spring clip fastener 2214 can be applied after the IOL 2212 has been positioned on the iris 104.

[0174] Figure 23A This is a perspective view of a spiral coil fastener 2314 having a rectangular wire ring head 2334 for attaching the IOL 2212 to the iris 104. The IOL assembly includes the above-mentioned... Figures 2A-3E and Figure 22B All components discussed, including the enlarged haptic foot 2224, except for the spiral coil fastener 2314. The spiral coil fastener 2314 includes a spiral wire 2336 with a pointed tip 2238, and a rectangular wire annular head 2334 extending from the top of the spiral wire 2336.

[0175] Figure 23B It is used for attachment Figure 23A A perspective view of the head of the fastener applicator tool 2370 for the helical coil fastener 2314. The fastener applicator tool 2370 includes a 90-degree drive 2376 for holding and rotating the helical coil fastener 2314. When desired, the 90-degree drive 2376 presses to release the helical coil fastener 2314 and can spring back to remove the helical coil fastener 2314 (e.g., reverse drive). Once installed, Figure 22B The tactile foot 2224 can be pushed through the ring of the rectangular line annular head 2334 to attach IOL 2312 relative to the iris 104.

[0176] Figure 24A Is with Figure 24B The diagram shows a perspective view of a U-shaped fastener 2414 used in conjunction with the fastener applicator tool 2470. The IOL component includes the above-mentioned... Figures 2A-3E and Figure 22B All components discussed, including the enlarged tactile foot 2224—except for the U-shaped fastener 2414. The U-shaped fastener 2414 includes first and second tips 2438 extending in the same direction and angled relative to the first and second arms 2436 of the U-shaped fastener 2414. In this way, the U-shaped fastener 2414 can be rotatably inserted into the iris tissue. In other words, the U-shaped fastener 2414 enters the iris 104 at an angle. Then it can be similar to... Figure 22B In this way, the tactile element is inserted and secured. In other words, the U-shaped fastener 2414 (e.g., a clip) can then capture the tactile element of the implant onto the iris 104.

[0177] Figure 24B It is used for attachment Figure 24A A perspective view of the fastener applicator tool 2470 for the U-shaped fastener 2414. The fastener applicator tool 2470 includes a slit 2476 at its end to receive a portion of the U-shaped fastener 2414.

[0178] Figure 25A and Figure 25B This is a view of the IOL assembly 2510 with spring flap fastener 2514. Figure 25A The IOL component 2510 includes the above-mentioned... Figures 2A-3E All components discussed, except for the haptic element 2518, include a spring flap fastener 2514 at its distal end (and / or at the distal end of the raised portion 2520 of the haptic element 2518). The spring flap fastener 2514 may be curved and includes first and second ends 2500 extending beyond the end of the haptic element 2518. The spring flap fastener 2514 may include a blade on its bottom surface to cut into the iris 104 and / or the spring flap fastener 2514 may be inserted into a pre-made cut in the iris 104 (and the flap is folded). Once in the cut, the spring flap fastener 2514 can be opened, thereby holding the IOL 2512 in place.

[0179] Figure 25B It is used to Figure 25AA perspective view of a fastener applicator tool 2570 attached to the iris 104 with a spring flap fastener 2514 of the IOL assembly. The fastener applicator tool 2570 is a sleeve defining a channel 2576. The width of the channel 2576 is smaller than the width of the spring flap fastener 2514, such that when the fastener applicator tool 2570 is slid up, the first and second ends 2500 bend forward (as shown by dashed lines), and when the fastener applicator tool 2570 is slid out, the first and second ends 2500 bend toward their natural (e.g., straight or curved) orientation (as shown by solid lines).

[0180] The embodiments disclosed herein are exemplary and may be provided in any desired combination. Those skilled in the art will recognize improvements and modifications to the embodiments disclosed herein. Many modifications and other embodiments of the invention set forth herein will come to mind for those skilled in the art, taking advantage of the teachings presented in the foregoing description and the associated drawings. All such improvements and modifications are considered to be within the scope of the concepts disclosed herein.

[0181] It should also be noted that the operational steps described in any exemplary embodiment herein are described to provide examples and discussion. The described operations can be performed in many different sequences besides the sequence illustrated. Furthermore, the operations described in a single operational step can actually be performed in many different steps. Additionally, one or more operational steps discussed in the exemplary embodiments can be combined. It should be understood that it will be apparent to those skilled in the art that the operational steps illustrated in the flowcharts can be subject to many different modifications.

[0182] Furthermore, it should be understood that the embodiments are not limited to the specific embodiments disclosed, and modifications and other embodiments are intended to be included within the scope of the appended claims. It is intended that the embodiments cover modifications and variations of the invention—provided they fall within the scope of the appended claims and their equivalents. Although specific terminology is used herein, it is used in a general and descriptive sense only, not for limiting purposes.

[0183] The prior description of this disclosure is provided to enable any person skilled in the art to make or use this disclosure. Various modifications to this disclosure will be apparent to those skilled in the art, and other variations can be applied to the general principles defined herein without departing from the spirit or scope of this disclosure. Therefore, this disclosure is not intended to be limited to the examples and designs described herein, but is to be accorded the widest scope consistent with the principles and novel features disclosed herein.

Claims

1. A surgical tool for attaching an intraocular lens assembly to the iris, comprising: A user-accessible actuator-controlled handle; and A cannula, extending from one end of the handle, includes a proximal opening and a distal opening, the distal opening being fixed perpendicularly to the proximal opening; and The surgical tool is configured to rotate, in response to actuator control, a first helical coil fastener located at least partially in the distal opening of the cannula, attaching the first tactile element of the intraocular lens assembly to the eye by inserting it into the first cavity of the first tactile element and rotatably penetrating the iris.

2. The surgical tool as described in claim 1, wherein, The surgical instrument is pre-loaded with the first spiral coil fastener.

3. The surgical tool as described in claim 1, wherein, The surgical instrument is pre-loaded with the second helical coil fastener.

4. The surgical tool as described in claim 1, The artificial lens assembly further includes: A second tactile element extending from the optical element, the second tactile element including a second cavity; and The second spiral coil fastener includes a top and a line extending downward from the top, the second spiral coil fastener being configured to attach the second tactile element to the eye by inserting it into a second cavity of the second tactile element and rotatably penetrating the iris; The first tactile element and the second tactile element are both integrally connected to the optical element; Wherein, the artificial lens defines a first hole between the outer periphery of the optical element and the first foot of the first tactile element, and the artificial lens defines a second hole between the outer periphery of the optical element and the second foot of the second tactile element; The optical component includes at least one of the following optical features: refractive features, diffraction features, multifocal features, bifocal features, extended-range focusing or visual features, or aspheric features. The optical element is configured to produce a preselected optical effect, including the correction of at least one of myopia, hyperopia, presbyopia, or astigmatism. Wherein, both the first and second helical coil fasteners include a tip; and The top of each of the first and second helical coil fasteners includes a head, the width of which is greater than the helical diameter of the wire.

5. The surgical tool as described in claim 1, The artificial lens assembly further includes: A second tactile element extending from the optical element, the second tactile element including a second cavity; The second spiral coil fastener includes a top and a line extending downward from the top, the second spiral coil fastener being configured to attach the second tactile element to the eye by inserting it into a second cavity of the second tactile element and rotatably penetrating the iris; The first washer ring is located in the first cavity of the first tactile element; and The second washer ring is located in the second cavity of the second tactile element; The first tactile element and the second tactile element are both integrally connected to the optical element; Wherein, the artificial lens defines a first hole between the outer periphery of the optical element and the first foot of the first tactile element, and the artificial lens defines a second hole between the outer periphery of the optical element and the second foot of the second tactile element; The optical component includes at least one of the following optical features: refractive features, diffraction features, multifocal features, bifocal features, extended-range focusing or visual features, or aspheric features. The optical element is configured to produce a preselected optical effect, including the correction of at least one of myopia, hyperopia, presbyopia, or astigmatism. Both the first spiral coil fastener and the second spiral coil fastener include a tip; The top of the first helical coil fastener includes a head, the width of which is approximately the same as the helical diameter of the wire. Both the first washer and the second washer include a shaft, a first flange at a first end of the shaft, and a second end of the shaft without a flange.

6. The surgical tool as described in claim 1, in, The artificial lens assembly further includes: A second tactile element extending from an optical element, the second tactile element including a second cavity; The second spiral coil fastener includes a top and a line extending downward from the top, the second spiral coil fastener being configured to attach the second tactile element to the eye by inserting it into a second cavity of the second tactile element and rotatably penetrating the iris; The first washer ring located in the first cavity of the first tactile element; and The second washer ring is located in the second cavity of the second tactile element; The first tactile element and the second tactile element are both integrally connected to the optical element; Wherein, the artificial lens defines a first hole between the outer periphery of the optical element and the first foot of the first tactile element, and the artificial lens defines a second hole between the outer periphery of the optical element and the second foot of the second tactile element; The optical component includes at least one of the following optical features: refractive features, diffraction features, multifocal features, bifocal features, extended-range focusing or visual features, or aspheric features. The optical element is configured to produce a preselected optical effect, including the correction of at least one of myopia, hyperopia, presbyopia, or astigmatism. Both the first spiral coil fastener and the second spiral coil fastener include a tip; The top of the first helical coil fastener includes a head, the width of which is approximately the same as the helical diameter of the wire. The first tactile element and the second tactile element both include pawls to prevent the first spiral coil fastener from accidentally entering the iris tissue and to prevent the first spiral coil fastener from accidentally disengaging from the first tactile element. Wherein, the first helical coil fastener is preloaded in the first washer, and the second helical coil fastener is preloaded in the second washer; and Both the first washer and the second washer include a shaft, a first flange at a first end of the shaft, and a second end of the shaft without a flange.

Images