Haptic optic management system utilizing rotating cams

By introducing a tactile optical management system into the endoscopic tool, the problem of insufficient tool size and function under small incisions is solved, and effective use under small incisions and shortening surgical recovery time is achieved.

JP2025074274APending Publication Date: 2025-05-13ALCON INC
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Patent Information

Application Number
JP2025033486
Authority / Receiving Office
JP · JP
Patent Type
Applications
Current Assignee / Owner
Priority Date
2018-12-13
Filing Date
2025-03-04
Publication Date
2025-05-13

AI Technical Summary

Technical Problem

In ophthalmic surgery, especially in endoscopic surgery under small incisions, the size and function of existing tools limit their effective use under small incisions, resulting in an extended recovery time after surgery.

Method used

A tactile optical management system including the first and second fixture assemblies is employed, which pushes the tactile portion of the endoscope to cover its optical portion by rotating the first fixture assembly and folds the optical portion of the endoscope by rotating the second fixture assembly to reduce its size to adapt it to a small incision.

Benefits of technology

Through the use of this system, the size of the endoscopy can be effectively reduced, making it easier to insert and use under small incisions, thereby shortening the recovery time after surgery.

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Abstract

To improve a haptic optic management system.SOLUTION: Systems, methods and devices for inserting an intraocular lens (IOL) into an eye may be provided. An example haptic optic management system may comprise a first cam assembly comprising: a first cam body portion; an opening in the first cam body portion; and haptic folder arms disposed in the opening. The haptic optic management system may further comprise a second cam assembly positioned on one side of the first cam assembly, where the second cam assembly comprises a second cam body portion, an opening in the second cam body portion, and optic folders disposed in the opening. The haptic optic management system may further comprise a central plate for holding an intraocular lens in the opening of the second cam body portion, where the central plate is disposed between the first cam assembly and the second cam assembly.SELECTED DRAWING: Figure 6
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Description

[Background technology]

[0001] The human eye can suffer from many diseases, causing anything from mild deterioration to complete loss of vision. Contact lenses and glasses can compensate for some ailments, while eye surgery may be necessary in other cases. In general, eye surgery can be categorized into posterior segment surgery, such as vitreoretinal surgery, and anterior segment surgery, such as cataract surgery. Vitreoretinal surgery can address many different eye conditions, including, but not limited to, macular degeneration, diabetic retinopathy, diabetic vitreous hemorrhage, macular hole, retinal detachment, epiretinal membrane, and cytomegalovirus retinitis.

[0002] In the case of cataract surgery, the surgical procedure may require an incision and the insertion of a tool into the eye to replace the clouded natural lens with an intraocular lens ("IOL"). Larger incision sites may result in longer post-operative healing times. To reduce this healing time, typical surgical procedures have shifted to making incisions in the eye of approximately 2 millimeters in size. While this smaller incision size may reduce post-operative healing times, as the incision size continues to shrink, issues such as the size and functionality of the insertion tool may arise. Typically, the insertion tool is preloaded with an IOL that can be inserted into the patient's eye once the clouded natural lens is removed. The insertion tool may include a plunger to push the IOL out of the nozzle of the insertion tool. The plunger may have additional functions such as pushing with haptics and folding the IOL. Once the incision is made, the insertion tool may be inserted into the eye through the incision and the folded IOL may be dispensed into the eye by actuation of the plunger. As the incision site shrinks, the size of the nozzle of the insertion tool may decrease accordingly. Summary of the Invention [Means for solving the problem]

[0003] In an exemplary aspect, the present disclosure is directed to a haptic optics management system. The haptic optics management system may include a first cam assembly including a first cam body portion, an opening in the first cam body portion, and a haptic folder arm disposed in the opening. The haptic optics management system may further include a second cam assembly disposed on one side of the first cam assembly, the second cam assembly including a second cam body portion, an opening in the second cam body portion, and an optics folder disposed in the opening. The haptic optics management system may further include a center plate for holding an intraocular lens in the opening in the second cam body portion, the center plate being disposed between the first cam assembly and the second cam assembly.

[0004] In another exemplary aspect, the present disclosure relates to an insertion tool. The insertion tool may include a drive system, the drive system including a body. The insertion tool may further include a plunger at least partially disposed on the drive system. The insertion tool may further include a nozzle. The insertion tool may further include a haptic optics management system disposed between the drive system and the nozzle to receive a distal tip of the plunger. The haptic optics management system may include a first cam assembly including a first cam body portion, an opening in the first cam body portion, and a haptic folder arm disposed in the opening. The haptic optics management system may further include a second cam assembly disposed on one side of the first cam assembly, the second cam assembly including a second cam body portion, an opening in the second cam body portion, and an optics folder disposed in the opening. The haptic optics management system may further include a center plate for holding an intraocular lens in the opening in the second cam body portion, the center plate being disposed between the first cam assembly and the second cam assembly.

[0005] In another exemplary aspect, the present disclosure is directed to a method of providing an intraocular lens. The method may include rotating a first cam assembly to push haptics of the intraocular lens over an optic portion of the intraocular lens. The method may include further rotating the first cam assembly such that the first cam assembly engages a second cam assembly to rotate the second cam assembly while engaging the intraocular lens and folding the optic portion of the intraocular lens. The method may further include actuating a drive system to dispense the intraocular lens through a nozzle into the eye.

[0006] Different aspects may include one or more of the following features: The haptics optics management system may further comprise a base cap disposed opposite the second cam assembly from the first cam assembly, the base cap including a hole extending from the haptics folder arm and receiving a pin about which the haptics folder arm rotates. The base cap may further comprise a concave ring and a raised central surface defined by the concave ring, the concave ring receiving the raised ring formed about the second cam body portion. The central plate may further comprise a lens surface and a channel extending at least partially across the lens surface, the first pair of guides and the second pair of guides respectively disposed on either side of the channel, the channel receiving the optics folder. Each optic holder may include a body portion, a tab extending from the body portion to engage the second cam body portion, and a ramp at an opposite end of the body portion from the tab and operable to engage the optic of the intraocular lens when the second cam assembly is actuated, and each optic holder further includes a protrusion from the opposite side of the body portion disposed in a protrusion channel formed in at least one of the first pair of guides or the second pair of guides.

[0007] Different aspects may also include one or more of the following features. The first cam body portion may include an outer periphery and an inner periphery. The inner periphery of the first cam body portion may define an opening of the first cam body portion and one or more cam surfaces operable to engage the haptics folder arm when the first cam assembly is actuated. The cam protrusion may extend from the first cam body portion at the outer periphery. The second cam body portion may include an outer periphery and an inner periphery. The inner periphery of the second cam body portion may define an opening of the second cam assembly and one or more cam surfaces operable to engage the optics folder arm when the second cam assembly is actuated. The recess may be formed in the outer periphery of the second cam body portion. The first cam assembly may be positioned such that the cam protrusion is disposed in the recess between the first and second ends of the recess. Each of the haptic folder arms may have a first end and a second end and may include a protrusion at the first end and a pin extending from the second end, with each protrusion of the haptic folder arm extending through a corresponding opening in the central plate. Each protrusion of the haptic folder arm may be operable to follow one or more cam surfaces formed around the opening of the first cam assembly such that when the first cam assembly is actuated, the one or more cam surfaces engage the protrusion to cause rotation of the haptic folder arm. Each of the first cam assembly and the second cam assembly may be disk-shaped. An intraocular lens may be disposed on the central plate, the intraocular lens may include an optic disposed on a channel formed in a lens surface of the central plate, and the intraocular lens may further include a haptic extending from the optic across the one or more openings in the central plate.

[0008] Different aspects may also include one or more of the following features. The plunger may be operable to engage the intraocular lens when the drive system is actuated to dispense the intraocular lens from the nozzle. The drive system may include a lever and a pneumatic system. The first cam assembly may include a first cam body portion, an opening in the first cam body portion, a haptic folder arm disposed in the opening, and one or more cam surfaces formed around the opening in the first cam body portion. The one or more cam surfaces of the first cam assembly may engage the haptic folder arm as the first cam assembly rotates such that the haptic folder arm rotates to push the haptic over the optic. The second cam assembly may include a second cam body portion, an opening in the second cam body portion, an optic folder disposed in the opening, and one or more cam surfaces formed around the opening in the first cam body portion. One or more cam surfaces of the second cam assembly may engage the optic folder as the second cam assembly rotates to push the optic folder inward toward one another while engaging the intraocular lens, thereby folding the optic onto itself. Rotating the first cam assembly may include applying a force to a cam protrusion extending from an outer periphery of the first cam body portion such that the cam protrusion rides in a recess formed in an outer periphery of the second body portion. Further rotation of the first cam assembly may cause the cam protrusion to push an end of the recess to rotate the second cam assembly.

[0009] It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory in nature and are intended to provide an understanding of the present disclosure without limiting the scope of the disclosure. In that regard, additional aspects, features, and advantages of the present disclosure will become apparent to those skilled in the art from the following detailed description.

[0010] These drawings illustrate certain aspects of some embodiments of the present disclosure and should not be used to limit or define the present disclosure. [Brief description of the drawings]

[0011] [Figure 1] FIG. 1 shows a schematic diagram of an exemplary insertion tool operable to deliver an IOL into an eye. [Figure 2A] FIG. 2A shows an eye having an IOL introduced from an insertion tool. [Figure 2B] FIG. 2B illustrates the eye shown in FIG. 2A with the IOL positioned within the capsular bag of the eye and the insertion tool removed from the eye. [Diagram 3] FIG. 3 illustrates a perspective view of another exemplary insertion tool operable to deliver an IOL into an eye. [Figure 4] FIG. 4 shows a top view of the insertion tool of FIG. [Diagram 5] FIG. 5 shows a side view of the insertion tool of FIG. [Figure 6] FIG. 6 is a detailed view of the distal end of the insertion tool of FIG. [Figure 7] FIG. 7 illustrates an exemplary haptic-optics management. [Figure 8] FIG. 8 shows the center plate of the haptic-optics management system of FIG. [Figure 9] FIG. 9 illustrates a first cam assembly of the haptic optics management system of FIG. [Figure 10] FIG. 10 shows the base cap of the haptic optics management system of FIG. [Figure 11] FIG. 11 illustrates a second cam assembly of the haptic optics management system of FIG. [Figure 12] FIG. 12 shows the haptics optics management system of FIG. 7 with the haptics folder arms in their actuated position during operation. [Figure 13] FIG. 13 shows the haptic optics management system of FIG. 7 with the optics folder in its active position during operation. [Figure 14] FIG. 14 illustrates a method of preparing an intraocular lens (IOL) for delivery via an IOL insertion tool. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0012] For the purpose of facilitating an understanding of the principles of the present disclosure, reference will now be made to the implementations shown in the drawings and specific language will be used to describe the same. It will nevertheless be understood that no limitation on the scope of the disclosure is intended. Any alternatives and further modifications to the described devices, apparatus, and methods, and any further applications of the principles of the present disclosure are fully contemplated as would normally occur to one skilled in the art to which the disclosure pertains. In particular, it is fully contemplated that features, components, and / or steps described with reference to one or more implementations may be combined with features, components, and / or steps described with reference to other implementations of the present disclosure. For simplicity, in some cases, the same reference numbers may be used throughout the drawings to refer to the same or similar parts.

[0013] Exemplary embodiments described herein relate generally to ophthalmic surgery. More specifically, exemplary embodiments relate generally to systems, methods, and devices for inserting an intraocular lens ("IOL") into an eye. The embodiments may include an insertion tool for preparing and providing the IOL into a patient's eye, including a plunger, a nozzle, and a haptic optics management system. In some embodiments, the haptic management system can fold the IOL and push in one or more haptics of the IOL. The haptics extend from the optics of the IOL and stabilize the IOL when placed in the capsular bag of the eye. After the IOL is prepared, the plunger pushes the IOL out of the nozzle through the insertion tool.

[0014] FIG. 1 shows a schematic diagram of an insertion tool 100. In some embodiments, the insertion tool 100 may include a drive system 102, a plunger 104, a haptics optics management system (interchangeably referred to as "HOMS") 106, and a nozzle 108. The drive system 102 may be any system or combination of components operable to actuate the plunger 104. For example, the drive system 102 may utilize a lever and / or pneumatic system, a manually actuated system or component, a hydraulic system, or other device operable to actuate the plunger 104 to advance, partially advance, or fully deliver the IOL 110 from the insertion tool 100. The plunger 104 is coupled to the drive system 102. The drive system 102 is operable to actuate the plunger 104. For example, the drive system 102 may be powered, for example, electrically, mechanically, hydraulically, pneumatically, a combination thereof, or some other method. In response to the drive system 102, the plunger 104 moves through the HOMS 106. The HOMS 106 may be disposed between the drive system 102 and the nozzle 108. In alternative embodiments, the HOMS 106 may be disposed at other locations within the insertion tool 100. In some embodiments, the HOMS 106 may include the IOL 110 in an unfolded position.

[0015] The drive system 102 can be any system, component, or group of components operable to advance the IOL 110 through the insertion tool 100. For example, the drive system 102 includes a plunger, shown generally in FIG. 1 as plunger 104, operable to engage the IOL 110 disposed within the insertion tool 100 and advance the IOL 110 within the insertion tool 100. In some cases, the plunger 104 is operable to eject the IOL from the insertion tool 100.

[0016] In some cases, the drive system 102 can be a manually driven system. That is, in some cases, a user applies a force to operate the drive system 102. The exemplary drive system 102 includes a plunger 104 that is manually engageable, directly or indirectly, by a user to push the plunger 1044 through the insertion tool 100. Upon advancement, the plunger 104 engages the IOL 110 and advances the IOL 110 through the insertion tool 100, which may also include ejecting the IOL 110 from the insertion tool 100. A non-limiting example of a manual IOL insertion tool is shown in U.S. Patent Application Publication No. 2016 / 0256316, the entire contents of which are incorporated herein by reference in their entirety. According to other implementations, the drive system 102 can be an automated system. Examples of automated drive systems are shown in U.S. Patent Nos. 8,808,308, 8,308,736, and 8,480,555, the entire contents of each of which are incorporated herein by reference in their entirety. Still further, other automated drive systems within the scope of the present disclosure are described in U.S. Patent No. 8,998,983 and U.S. Patent Application Publication No. 2017 / 0119522, the entire contents of each of which are incorporated herein by reference in their entirety. While exemplary drive systems are provided by way of example, these systems are not intended to be limiting. Rather, any component, group of components, system, device, mechanism, or combination thereof operable to advance the IOL 110 is within the scope of the present disclosure.

[0017] 1, the IOL 110 is a single-piece IOL that includes an optic 114 and haptics 112 extending from opposite sides of the optic 114. For example, in the exemplary IOL 110 shown in FIG. 1, the haptics 112 are disposed 180° relative to one another along the circumference of the optic 114. However, other types of IOLs are within the scope of the present disclosure. For example, a multi-piece IOL in which the optic and one or more haptics are separate components may also be used.

[0018] The IOL 110 may have a shape similar to that of the natural lens of the eye (e.g., eye 200 shown in FIG. 2A). The IOL 110 may be made from a number of materials, including, but not limited to, silicone, acrylic, and / or combinations thereof. Other materials are also envisioned. The haptics 112 extend from the periphery of the optic 114 and function to stabilize the IOL 110 when placed in the eye.

[0019] In some cases, the HOMS 106 can be actuated to push the haptics 112 onto the optic 114 and fold the optic 114. For example, the HOMS 106 can operate to fold the haptics 112 onto the optic 114 and fold the optic 114 over or around the folded haptics 112. The IOL 110 is shown in a folded configuration at 116. The folded configuration 116 of the optic 114 can include one or more haptics 112 folded against the optic 114 and can optionally include the optic 114 folded against one or more haptics 112. The plunger 104 can advance through the HOMS 106 once the HOMS 106 has folded the IOL 110. As the plunger 104 moves through the HOMS 106, the plunger 104 displaces the folded IOL 110 from the HOMS 106. For example, the plunger 104 can push the folded IOL 110 into and through the nozzle 108 .

[0020] FIG. 2A illustrates a patient's eye 200 undergoing surgery with an insertion tool 100. As illustrated, the insertion tool 100 dispenses a folded IOL 110 into the patient's eye 200. In some embodiments, an incision 202 is made in the eye 200, for example, by a surgeon. For example, in some cases, the incision 202 may be made through the sclera 204 of the eye 200. In other examples, the incision may be formed in the cornea 209 of the eye 200. The incision 202 may be sized to allow for insertion of a portion of the insertion tool 100 to provide the folded IOL 110 within the capsular bag 208. For example, in some cases, the size of the incision 202 may be less than about 2000 microns (2 millimeters) in length. In other examples, the incision 202 can have a length of about 0 microns to about 500 microns, about 500 microns to about 1000 microns, about 1000 microns to about 1500 microns, or about 1500 microns to about 2000 microns.

[0021] After the incision 202 is made, the insertion tool 100 is inserted through the incision into the interior 206 of the eye 200. The insertion tool 100 is actuated to dispense the folded IOL 110 into the capsular bag 208 of the eye 200. Once dispensed, the folded IOL 110 returns to its initial, unfolded state, and the IOL 110 is placed within the capsular bag 208 of the eye 200, as shown in FIG. 2B. The capsular bag 208 holds the IOL 110 within the eye 200 in a relationship relative to the eye 200 such that the optic 114 refracts light directed toward the retina (not shown). The haptics 112 of the IOL 110 engage the capsular bag 208 to secure the IOL 110 therein. After dispensing the IOL 110 into the capsular bag 208, the insertion tool 100 is removed from the eye 200 through the incision 202, allowing the eye 200 to heal for a period of time.

[0022] 3-5 illustrate an exemplary insertion tool 100 operable to deliver an IOL into an eye (e.g., IOL 110 in eye 200 shown in FIGS. 2A and 2B). As shown, insertion tool 100 includes a drive system 102, a haptic optics management system 106, and a nozzle 108. Insertion tool 100 may also include a plunger, which may be similar to plunger 104 shown in FIG. 1. In some cases, plunger 104 may be actuated to advance the IOL within insertion tool 100, which may be similar to IOL 110 shown in FIG. 1, in some cases dispensing IOL 110 from insertion tool 100.

[0023] 3, the drive system 102 includes a body 302 and a lever 304 that may be pivotally coupled to the body 302. The nozzle 108 is coupled to a distal end 308 of the body 302. The HOMS 106 is disposed between the body 302 and the nozzle 108. In some cases, the nozzle 108 may be integrally connected to the body 302. In other examples, the nozzle 108 may be separate from the body 302 and coupled to the body 302 via an interlocking relationship. In some cases, the HOMS 106 and the nozzle 108 may be integrally formed. In other examples, the HOMS 106, the nozzle 108, and the body 302 may be integrally formed.

[0024] In some cases, the body 302 may have a slender, elongated shape. In some cases, the body 302 may have a first portion 310 and a second portion 312. In some cases, the second portion 312 may be disposed at least partially above the first portion 310. In the example shown, the second portion 312 includes a plurality of apertures 314. A plurality of tabs 316 formed on the first portion 310 are received within the apertures 314 to couple the first portion 310 and the second portion 312. The tabs 316 may form a fitting interlock with the apertures 314. However, the structure of the body 302 of the exemplary insertion tool 100 shown in FIGS. 3-5 is merely a non-limiting example. In some cases, the body 302 may be a single, integral part. In some cases, the body 302 may include one or more cylindrical parts. Additionally, the body 302 may be constructed in any desired manner from any number of components.

[0025] 3-5, the body 302 also includes reliefs 318, 319, and 320. The reliefs 318, 319, and 320 are, for example, shallow recesses formed in the body 302 to accommodate one or more fingers of a user. One or more of the reliefs 318, 319, and 320 may include a textured surface 322 that may provide a user with improved grip and control over the insertion tool 100. As shown in FIGS. 3 and 5, the relief 318 may include the textured surface 322. However, the scope may not be so limited. Rather, any or all of the reliefs 318, 319, and 320 may include the textured surface 322, or none of them may include the textured surface 322. Similarly, the lever 304 may also include the textured surface 324. However, in some cases, the lever 304 may not include the textured surface.

[0026] 3, the nozzle 108 includes a distal tip 326 that defines an opening 328. The nozzle 108 also includes a flared portion or wound guard 330. The distal tip 326 may be adapted to be inserted into an incision made in the eye, such as the incision 202 in the eye 200 shown in FIGS. 2A and 2B, to provide a folded IOL therein. The wound guard 330 may include an end surface 332 operable to contact an exterior surface to limit the depth to which the distal tip 326 penetrates the eye 200. In some embodiments, the wound guard 330 may be omitted.

[0027] In some embodiments, the insertion tool 100 may be preloaded. That is, the insertion tool 100 may include an IOL disposed therein when provided to an end user. In some cases, the IOL may be disposed in the insertion tool 100 in an unfolded state and ready to be provided to a patient. Having the insertion tool 100 preloaded with an IOL reduces the number of steps that a user must both perform before providing the IOL to a patient. For example, a preloaded insertion tool eliminates any steps that a user would otherwise need to perform to load an IOL into the insertion tool. Reducing the number of steps can reduce errors and risks associated with providing an IOL to a patient. Additionally, the amount of time required to provide an IOL may also be reduced. In some embodiments, the IOL may be preloaded in the HOMS 106.

[0028] 6 illustrates a close-up view of an exemplary insertion tool 100 with a haptic optics management system 106. The HOMS 106 can include a first cam assembly 700, a second cam assembly 702, and a base cap 1000. The first cam assembly 700 can be disposed between the second cam assembly 702 and the base cap 1000. The HOMS 106 is operable to fold the IOL. The folded IOL can be received in the housing 600 for dispensing from the nozzle 108. For example, in some instances, the HOMS 106 can be operable to fold the IOL from an unstressed state to a fully folded configuration, such as shown in FIG. 1. During folding, the HOMS 106 can tuck or fold the haptics 112 onto the optics 114 of the IOL 110, and can fold the ends of the optics 114 onto the tucked haptics 112 to capture the haptics 112, thereby placing the IOL 110 in a folded configuration, as shown, for example, in FIG. 1 .

[0029] For example, as shown in FIGS. 3-6, the HOMS 106 is sized to be commensurate with the size of the insertion tool 100. That is, the HOMS 106 has a compact size that avoids or limits the amount of obstruction to the surgeon's vision while inserting the IOL into the eye. However, the scope of the present disclosure is not so limited. Rather, in some cases, the size and / or shape of the haptics optical management system may be selected to be any desired size or shape. Additionally, although the HOMS 106 is shown disposed at the distal end of the insertion tool 100, the haptics optical management system 106 may be disposed anywhere within or along the insertion tool 100. In some embodiments, the HOMS 106 may be disposed between the nozzle 108 and the drive system 102.

[0030] In the example shown in FIGS. 3-6 , the HOMS 106 is disposed between the distal end 308 of the body 302 and the nozzle 108. In some cases, the HOMS 106 may be removably coupled to the nozzle 108 and / or the drive system 102. For example, the HOMS 106 may be removably coupled to the body 302 using fasteners or adhesives. In still other implementations, the HOMS 106 may be coupled to the body 302 by a snap-fit ​​engagement or any other desired connection method. Without limitation, exemplary fasteners may include nuts and bolts, washers, screws, pins, sockets, rods and studs, hinges, and / or any combination thereof.

[0031] 7 illustrates an exemplary haptic optics management system 106. In the illustrated example, the haptic optics management system 106 includes a first cam assembly 700, a second cam assembly 702, and a central plate 704. The central plate 704 is disposed between the first cam assembly 700 and the second cam assembly 702. In the example, the central plate 704 is disposed above the first cam assembly 700 in a concentric manner. As illustrated, the IOL 110 is disposed on the lens surface 706 of the central plate 704 in the opening 708 of the second cam assembly 702.

[0032] FIG. 8 illustrates a center plate 704. The center plate 704 may be made of materials such as, for example, metals, non-metals, polymers, ceramics, and / or combinations thereof. The center plate 704 may have any suitable size and / or shape. As illustrated, the center plate 704 may be disk-shaped in that the center plate 704 is generally circular. However, other shapes are also envisioned. For example, but not limited to, the center plate 704 may be formed such that all or a portion of the center plate 704 is oval, triangular, rectangular, square, hexagonal, and / or combinations thereof. As illustrated, the center plate 704 includes a lens surface 706 and an edge 802 around the periphery of the lens surface 706. In the illustrated example, a channel 804 is formed in the lens surface 706. In some cases, the channel 804 extends across the entire lens surface 706. As shown, the channel 804 extends through the center 805 of the lens face 706 and along the midline 812 of the lens face 706. The channel 804 may be rectangular in cross section, for example, although the channel 804 may be otherwise formed as desired for a particular application.

[0033] The central plate 704 further includes a first pair of guides 806 and a second pair of guides 808. In some embodiments, the first pair of guides 806 and the second pair of guides 806 are disposed on ends 810 of the channel 804. The first pair of guides 806 and the second pair of guides 808 can be disposed on opposite sides of the IOL 110 from one another. In some embodiments, the first pair of guides 806 and the second pair of guides 806 are disposed equidistant from a center 805 of the lens surface 706 of the central plate 704. In an additional example, the first pair of guides 806 is symmetrical to the second pair of guides 808 about the center 805. In some embodiments, the first pair of guides 806 and the second pair of guides 808 can each include opposing protrusions 807. The respective protrusions 807 of the first pair of guides 806 and the second pair of guides 808 can be on opposite sides of the channel 804. As shown, protrusions 807 extend outwardly from lens surface 706. In some embodiments, each protrusion 807 of the first pair of guides and the second pair of guides 808 may include a protrusion channel 814 that faces inwardly toward channel 804, as shown in FIG.

[0034] Additionally, center plate 704 includes a first opening 816 and a second opening 818. In some embodiments, first opening 816 and second opening 818 are disposed on either side of channel 804. In examples, first opening 816 and second opening 818 include a first end 820 and a second end 822, respectively. In some cases, first opening 816 and second opening 818 may be displaced across midline 812 and channel 804.

[0035] The central plate 704 supports the IOL 110. As shown, the IOL 110 is disposed on the central plate 704 and supported by the lens surface 706. The IOL 110 includes haptics 112 and optics 114. In some embodiments, the optics 114 is disposed across a channel 804 in the lens surface 706, and an end 824 of the optics 114 is at least partially disposed on the lens surface 706. The haptics 112 extend from the optics 114 across the first opening 816 and the second opening 818. As shown, one of the haptics 112 extends across the first opening 816, while another of the haptics 112 extends across the second opening 818.

[0036] FIG. 9 illustrates a first cam assembly 700. The first cam assembly 700 may be made of materials such as, for example, metals, non-metals, polymers, ceramics, and / or combinations thereof. The first cam assembly 700 may have any suitable size and / or shape. As shown, the first cam assembly 700 may be annular in shape in that the center plate is generally shaped like a ring. However, other shapes are also envisioned. In the illustrated example, the first cam assembly 700 includes a first cam body portion 900 that includes an opening 902. The first cam body portion 900 further includes an inner circumference 904 that defines the opening 902 and an outer periphery 906. The diameter of the opening 902 is not uniform such that the diameter varies along the inner circumference 904 that defines one or more cam surfaces 905. In the illustrated embodiment, the inner circumference 904 defines two cam surfaces 905, although it is envisioned that there may be more or less than two cam surfaces 905. First cam assembly 700 further includes a raised ring 908 along the outer periphery 906 of first cam body portion 900. Raised ring 908 may be raised, for example, relative to lens surface 706. Raised ring 908 may have any suitable thickness and any suitable height above and / or below lens surface 706. First cam assembly 700 further includes cam protrusion 910. In the illustrated example, cam protrusion 910 is disposed on the outer periphery 906 and extends from raised ring 908.

[0037] In some embodiments, the first cam assembly 700 further includes haptics folder arms 912 disposed in the openings 902. When actuated (described in more detail below), the haptics folder arms 912 fold the haptics 112 (see, e.g., FIG. 7) over the optics 114 (see, e.g., FIG. 7). Each of the haptics folder arms 912 includes a first end 914 and a second end 916. A pin 918 extends from the second end 916. The pin 918 is received in a hole formed in the base cap (e.g., hole 1006 of the base cap 1000 shown in FIG. 10). The haptics folder arms 912 are operable to rotate about the pin 918 in that the pin 918 is a fixed component of the haptics folder arms 912 on which the haptics folder arms 912 rotate. The haptic folder arm 912 also includes a protrusion 920 at the second end 916. The protrusion 920 is operable to engage the haptics 112 (see, e.g., FIG. 7) of the IOL 110 (shown, e.g., in FIG. 1). The protrusion 920 includes a platform 922 and a haptics engagement surface 924. The platform 922 receives the haptics 112 of the IOL 110 (see, e.g., FIG. 7).

[0038] In some embodiments, an operator applies a force (either directly or indirectly) to the first cam assembly 700, thereby rotating the first cam assembly 700. The first cam assembly 700 may rotate about a transverse axis 926 that passes through a center 928 of the first cam assembly 700. As shown, the first cam assembly 700 may rotate in a direction indicated by an arrow 930. Although the arrow 930 indicates a counterclockwise rotation, it is also envisioned that the first cam assembly 700 may also be configured for clockwise rotation. A protrusion 920 of the haptic folder arm 912 moves along an inner circumference 904. At a given position, the diameter of the inner circumference 904 changes. As the diameter of the inner circumference 904 changes, the protrusion 920 follows the profile of the inner circumference 904. In some embodiments where the opening 902 may be elliptical in shape, the protrusion 920 moves from a portion of the inner circumference 904 having a larger diameter to a portion having a smaller diameter in that the protrusion 920 follows one or more cam surfaces 905 as the haptic folder arm 912 rotates.

[0039] FIG. 10 illustrates a base cap 1000. The base cap 1000 may be made from materials such as, for example, metals, non-metals, polymers, ceramics, and / or combinations thereof. The base cap 1000 may have any suitable size and / or shape. As illustrated, the base cap 1000 may be disc-shaped, in that the base cap 1000 is generally circular in shape. However, other shapes are also envisioned. For example, but not limited to, the base cap 1000 may be formed such that all or a portion of the base cap 1000 is oval, triangular, rectangular, square, hexagonal, and / or combinations thereof. In an example, the base cap 1000 includes a recessed ring 1002. The recessed ring 1002 may be located any suitable distance from the center of the base cap 1000. As illustrated, the recessed ring 1002 defines a raised central surface 1004. In some cases, the recessed ring 1002 of the base cap 1000 receives the raised ring 908 (see, e.g., FIG. 9 ) of the first cam assembly 700. In some embodiments, one or more holes 1006 are formed in the raised central surface 1004 of the base cap 1000. The one or more holes 1006 can receive the pins 918 of the haptics folder arms 912 (see, e.g., FIG. 9 ). The one or more holes 1006 can be disposed in any location on the base cap 1000 in any suitable manner. In some embodiments, the base cap 1000 also includes a protrusion 1008. The protrusion 1008 can have any suitable size and / or shape. For example, but not limited to, the protrusion 1008 can be formed such that all or a portion of the protrusion 1008 can have a cross-sectional shape that is circular, elliptical, triangular, rectangular, square, hexagonal, and / or combinations thereof. The protrusion 1008 is operable to align the base cap 1000 with respect to the first cam assembly 700 and the second cam assembly 702 .

[0040] FIG. 11 is a perspective view of the second cam assembly 702. The second cam assembly 702 may be made of materials such as, for example, metals, non-metals, polymers, ceramics, and / or combinations thereof. The second cam assembly 702 may have any suitable size and / or shape. The second cam assembly 702 may have any suitable size and / or shape. As shown, the second cam assembly 702 may be annular in shape in that the center plate is generally shaped like a ring. However, other shapes are also envisioned. In an embodiment, the second cam assembly 702 includes a second cam body portion 1100 that includes an opening 708. The second cam body portion 1100 includes an inner circumference 1102 that defines the opening 708 and an outer circumference 1104. The diameter of the opening 708 is not uniform such that the diameter varies along the inner circumference 1102 that defines one or more cam surfaces 1105. In the illustrated embodiment, the inner circumference 1102 defines two cam surfaces 1105, although it is envisioned that there may be more or less than two cam surfaces 1105. The second cam assembly 702 includes a recess 1106 in the outer circumference 1104. The recess 1106 functions to actuate the second cam assembly 702. The recess 1106 may be a portion of the second cam assembly 702 that is missing material along the outer circumference 1104. For example, the recess 1106 includes a first end 1108 and a second end 1110 that defines an arc length of the recess 1106.

[0041] As shown, the second cam assembly 702 further includes an optic folder 1112 disposed in the opening 708. In some cases, there may be multiple optic folders 1112. In the illustrated example, two optic folders 1112 are disposed in the opening 708. The optic folders 1112 are operable to move along the inner periphery 1102 of the opening 708 and within a channel 804 (e.g., shown in FIG. 8 ) formed in the lens surface 706 of the central plate 704. In some embodiments, each of the optic folders 1112 may be operable to follow one or more cam surfaces 1105. For example, each of the optic folders 1112 may be operable to follow a corresponding one of the cam surfaces 1105. As the diameter of the inner periphery 1102 changes, the optic folders 1112 must move toward the center 1103 of the second cam assembly 702 while following the one or more surfaces. The optic holder 1112 may be made from materials such as, for example, metals, non-metals, polymers, ceramics, and / or combinations thereof.

[0042] In some embodiments, each optic folder 1112 includes a tab 1114, a body portion 1116, a protrusion 1118, and a ramp 1120. The tab 1114 extends from the body portion 1116 opposite the ramp 1120 and may engage the second cam body portion 1100. The protrusion 1118 may be operable to guide the optic folder 1112 along one or more cam surfaces 1105. Any suitable means for connecting the optic folder 1112 to the second cam body portion 1100. The protrusion 1118 may extend from either side of the body portion 1116 of each optic folder 1112. One of the protrusions 1118 of each optic folder 1112 is hidden in FIG. 11 by a portion of the body portion 1116. The protrusions 1118 can slide within the protrusion channels 814 of the first pair of guides 806 (see, e.g., FIG. 8 ) and / or the second pair of guides 808 (see, e.g., FIG. 8 ). In an example, the ramp 1120 is an arcuate surface disposed on an opposite side of the body portion 1116 from the tab 1114. In other implementations, the ramp 1120 can have other shapes. For example, the ramp 1120 can have a shape that is non-arcuate. The ramp 1120 is operable to engage and fold the optics 114 (see, e.g., FIG. 7 ) when the optics folder 1112 is actuated.

[0043] Now, referring to Figures 7, 12, and 14, the operation of the haptics optics management system will be described. As shown in Figure 7, the IOL 110 is disposed in the haptics optics management system 106. The IOL 110 may be in a relaxed or unfolded state in which the haptics 112 extend from the optics 114. In the illustrated example, the IOL 110 is disposed on the central plate 704. The haptics folder arm 912 may be disposed partially through the first opening 816 and the second opening 818 of the central plate 704. In the illustrated example, the protrusion 920 of the haptics folder arm 912 is disposed in the first opening 816 and the second opening 818, respectively. As shown, the protrusion 920 is engaged with the haptics 112. The cam protrusion 910 of the first cam assembly 700 is disposed in the recess 1106 of the second cam assembly 702, for example, at the first end 1108 of the recess 1106. In other examples, the cam projection 910 may be otherwise disposed within the recess 1106, for example at the second end 1110.

[0044] 12, an example includes actuation of the first cam assembly 700 by rotation of the first cam assembly 700. In the example, rotation of the first cam assembly 700 actuates the haptics folder arm 912, causing the haptics folder arm 912 to pivot while folding the haptics 112 of the IOL 110 onto the optic 114. As previously described, the haptics folder arm 912 follows the inner circumference 904 (e.g., shown in FIG. 9) of the opening 902 (e.g., shown in FIG. 9), causing the haptics folder arm 912 to rotate and the corresponding protrusion 920 to move. In the illustrated example, the protrusion 920 moves from the first end 820 to the second end 822 of the first opening 816 and the second opening 818, respectively, in the central plate 704. As the first cam assembly 700 rotates, the cam protrusion 910 moves along the recess 1106. In some cases, the cam projection 910 may move from the first end 1108 of the recess 1106 to the second end 1110 of the recess 1106. In some embodiments, the first cam assembly 700 may be rotated approximately 90° to move the cam projection 910 from the first end 1108 to the second end 1110. In other examples, the first cam assembly 700 may be rotated other distances, for example, the first cam assembly 700 may be rotated more or less than 90°.

[0045] 13, an example includes actuation of the second cam assembly 702, for example, by continued rotation of the first cam assembly 700. In an example, the first cam assembly 700 pushes the second cam assembly 702 as the first cam assembly 700 continues to rotate. For example, the cam protrusion 910 engages the second end 1110 of the recess 1106 to push the second cam assembly 702, causing the second cam assembly 702 to rotate. In some embodiments, the optic folder 1112 is disposed in an opening 708 formed in the second cam assembly 702 and within a channel 804 formed in the lens surface 706 of the center plate 704. As the second cam assembly 702 rotates, the optic folder 1112 follows one or more cam surfaces 1105 formed on the inner periphery 1102 of the opening 708. As the diameter of the opening 708 decreases, the optic folder 1112 moves inwardly along the channel 804 while engaging the optic 114. As an example, a ramp 1120 (e.g., shown in FIG. 11 ) engages the optic 114. A first pair of guides 806 and a second pair of guides 808 guide the optic folder 1112 as they move inwardly within the channel 804. In some cases, the optic folder 1112 pushes the optic 114 out so as to fold the optic 114 onto itself and place the haptics 112 over the optic 114 to fold the IOL 110, such as into the folded configuration 116 for the IOL 110 shown in FIG. 1 . The IOL 110 can then be raised or lowered from the opening 708 into the housing 600 (e.g., shown in FIG. 6 ). Any suitable technique can be used to move the IOL 110 from the opening 708 into the housing 600. 1 can then be used to dispense the IOL 110 from the housing 600. The haptic optics management system 106 described herein can then be used to prepare the IOL 110 for insertion into the eye 200 (e.g., as shown in FIGS. 2A and 2B).

[0046] In various embodiments, the haptic optics management system ("HOMS") can be any of a wide variety of systems, devices, components, cartridges, etc. in an intraocular lens (IOL) delivery system that are configured to prepare an IOL for delivery. The HOMS can be disposed between the nozzle or tip of an IOL insertion tool and the plunger and / or drive system of the IOL insertion tool. For example, the HOMS can be a component in a multi-component modular IOL insertion tool having one or more cartridges, nozzle components, drive mechanism components, plunger components, nozzle components, HOMS components, etc. As described herein, the HOMS can be used with either modular IOL insertion tools or IOL insertion tools having permanently or semi-permanently attached components. In modular embodiments, the cartridge component including the HOMS can be coupled to the drive component. The HOMS can accept user actuation of the HOMS system to prepare an IOL contained therein for delivery by subsequent interaction from the plunger and / or drive mechanism.

[0047] As discussed above, the HOMS can include a system for accepting user actuation to prepare the IOL for delivery, and can include first and second cam assemblies for pushing and / or folding the haptics of the IOL over the optics of the IOL, folding the ends of the optic over the pushed haptics, and / or capturing the haptics and placing the IOL in a folded configuration for insertion through the nozzle of the IOL injector. However, depending on the material of the IOL, the shape of the IOL, whether or not the IOL has an internal volume, the material contained in the internal volume of the IOL, etc., the HOMS can be configured to accept user actuation to transform the IOL in a wide variety of configurations in preparation for being pushed through the nozzle of the IOL injector and ejected from the IOL injector.

[0048] As described above, the HOMS can be configured to deform and / or manipulate the haptics and / or optics of the IOL into various configurations. For example, in some cases, the HOMS can be configured to expand the haptics of the IOL in a substantially opposite direction away from the optics. For example, the HOMS can include a cavity for supporting a preloaded IOL and a cam mechanism for stretching and / or expanding the haptics and / or optics of the IOL. The cam mechanism can be actuated by a user to actively deform, stretch, expand, or otherwise fold features of the IOL (e.g., fold one haptic, fold multiple haptics, deform one haptic, deform multiple haptics, expand one haptic, expand multiple haptics, etc.) before the plunger of the IOL injector contacts the IOL and before the IOL is advanced into the nozzle of the IOL insertion tool. Those skilled in the art having the benefit of this disclosure will readily appreciate that a wide variety of modifications are possible and can be accomplished using the structures and principles described herein.

[0049] Although specific examples of cam assemblies are described above, for purposes of this disclosure, a cam can be any rotating or sliding component for converting a rotational motion into a linear motion for manipulating one or more components of an IOL (e.g., to deform, stretch, expand, or fold features of the IOL). The cam assembly can be actuated by a user via any suitable mechanism, including adjusting or rotating a dial, cap, or wheel on an IOL insertion tool. Alternatively, the cam mechanism can be actuated via manipulation of a non-rotating mechanism (e.g., a switch, lever, slide, button, etc.) that is mechanically linked to the cam mechanism to provide the appropriate rotational motion for deforming, stretching, expanding, or otherwise folding, as described above.

[0050] FIG. 14 illustrates a method 1400 for preparing an intraocular lens (IOL) for delivery via an IOL insertion tool as disclosed herein. In step 1405, a drive system of the modular IOL insertion tool may be coupled to an IOL cartridge, optionally including a preloaded IOL and a haptic optics management system ("HOMS"). In step 1410, the IOL cartridge may be coupled to a nozzle component of the modular IOL insertion tool. In step 1415, user actuation (e.g., via rotation of a dial) of the HOMS of the IOL insertion tool is translated to actively manipulate (e.g., deform, stretch, expand, or otherwise fold) one or more features of the preloaded IOL before the IOL is advanced into the nozzle component. This translation may be implemented in any suitable manner, for example, as discussed in the examples above. In some embodiments, the HOMS actively manipulates the IOL into a configuration suitable for advancement into the nozzle before the plunger or nozzle of the IOL insertion tool comes into contact with any feature of the IOL. In this manner, the IOL may be actively folded or expanded for advancement as a user step separate from engagement with the drive system and / or plunger. In step 1420, user actuation of the drive mechanism of the IOL insertion tool is translated to advance the IOL through the nozzle and deliver the IOL within the target (e.g., the capsule in front of the patient).

[0051] The operation and construction of the present disclosure will be apparent from the foregoing description. While the above apparatus and method have been characterized as preferred, various changes and modifications can be made therein without departing from the spirit and scope of the disclosure as defined in the following claims. The present disclosure also includes the following inventions. The first aspect is A tactile / optical unit management system, a first cam assembly including a first cam body portion, an opening in the first cam body portion, and a haptic folder arm disposed in the opening; a second cam assembly disposed on one side of the first cam assembly, the second cam assembly including a second cam body portion, an opening in the second cam body portion, and an optics holder disposed in the opening; a center plate for holding an intraocular lens in the opening of the second cam body portion, the center plate being disposed between the first cam assembly and the second cam assembly; The tactile / optical management system includes: The second aspect is A haptic optical management system in a first aspect, further comprising a base cap positioned on the opposite side of the second cam assembly from the first cam assembly, the base cap including a hole extending from the haptic folder arm and receiving a pin around which the haptic folder arm rotates. The third aspect is A haptic optical management system in a second aspect, wherein the base cap includes a concave ring and a raised central surface defined by the concave ring, the concave ring receiving a raised ring formed around the first cam body portion. The fourth aspect is A haptic optical management system in a first aspect, wherein the central plate includes a lens surface and a channel extending at least partially across the lens surface, a first pair of guides and a second pair of guides are respectively disposed on either side of the channel, and the channel receives the optical folder. The fifth aspect is A haptic optical management system in a fourth aspect, wherein each of the optic holders includes a body portion, a tab extending from the body portion and engaging with the second cam body portion, and a ramp at an opposite end of the body portion from the tab and operable to engage with the optic portion of the intraocular lens when the second cam assembly is actuated, and each of the optic holders further includes a protrusion from the opposite side of the body portion disposed in a protrusion channel formed in at least one of the first pair of guides or the second pair of guides. The sixth aspect is the first cam body portion includes an outer periphery and an inner periphery; the inner periphery of the first cam body portion defines the opening in the first cam body portion and one or more cam surfaces operable to engage the haptic folder arm when the first cam assembly is actuated; a cam projection extending from the first cam body portion at the outer periphery; the second cam body portion includes an outer periphery and an inner periphery; the inner periphery of the second cam body portion defines the opening of the second cam assembly and one or more cam surfaces operable to engage the optic holder when the second cam assembly is actuated; a recess is formed in the outer periphery of the second cam body portion; the first cam assembly is positioned such that the cam projection is disposed in the recess between a first end and a second end of the recess; 1 is a haptic / optical management system according to a first embodiment. The seventh aspect is A haptic optical management system in a first aspect, wherein each of the haptic folder arms has a first end and a second end and includes a protrusion at the first end and a pin extending from the second end, and each of the protrusions of the haptic folder arms extends through a corresponding opening in the central plate. The eighth aspect is A haptic optical management system in a seventh aspect, wherein each of the protrusions of the haptic folder arms is operable to follow one or more cam surfaces formed around the opening of the first cam assembly such that when the first cam assembly is actuated, the one or more cam surfaces engage with the protrusions to cause rotation of the haptic folder arm. The ninth aspect is The haptic optics management system of the first aspect, wherein the first cam assembly and the second cam assembly are each disk-shaped. A tenth aspect is A haptic optical portion management system in a first aspect, further comprising an intraocular lens disposed on the central plate, the intraocular lens including an optical portion disposed on a channel formed in a lens surface of the central plate, and the intraocular lens further including a haptic portion extending from the optical portion across one or more openings in the central plate. An eleventh aspect is 1. An intraocular lens (IOL) insertion tool, comprising: an IOL placed within the cavity; A nozzle; a plunger configured to advance the IOL through the nozzle; a haptic optics management system (HOMS) including a cam mechanism configured to translate user actuation of the HOMS to actively deform the IOL before the IOL is advanced into the nozzle; and An intraocular lens (IOL) insertion tool comprising: A twelfth aspect is An IOL insertion tool in an eleventh aspect, wherein the cam mechanism of the HOMS is further configured to convert the user actuation of the HOMS to actively deform the IOL without the IOL coming into contact with the nozzle or the plunger. A thirteenth aspect is An IOL insertion tool in accordance with a twelfth aspect, wherein the cam mechanism comprises one or more arms configured to move within the cavity in response to user actuation, thereby deforming the IOL. A fourteenth aspect is An IOL insertion tool in an eleventh aspect, wherein the HOMS is further configured to push one or more haptics of the IOL under the optic portion of the IOL and fold one or more ends of the optic portion of the IOL over the one or more pushed haptics of the IOL. The fifteenth aspect is The IOL insertion tool of an eleventh aspect, wherein the HOMS is further configured to extend a pair of haptics of the IOL in opposite directions.

Claims

1. 1. An intraocular lens (IOL) insertion tool, comprising: an IOL disposed within the cavity; A nozzle; a plunger configured to advance the IOL through the nozzle; a haptic optics management system (HOMS) including a cam mechanism configured to translate user actuation of the HOMS to actively deform the IOL prior to advancement of the IOL into the nozzle; Equipped with An intraocular lens (IOL) insertion tool, wherein the HOMS is further configured to push one or more haptics of the IOL into the optic section of the IOL and fold one or more ends of the optic section of the IOL over the one or more pushed haptics of the IOL.

2. 2. The IOL insertion tool of claim 1, wherein the cam mechanism of the HOMS is further configured to translate the user actuation of the HOMS to actively deform the IOL without the IOL making contact with the nozzle or the plunger.

3. 3. The IOL insertion tool of claim 2, wherein the cam mechanism comprises one or more arms configured to move within the cavity in response to the user actuation, thereby deforming the IOL.

4. The IOL insertion tool of claim 1 , wherein the HOMS is further configured to extend a pair of haptics of the IOL in opposite directions.

5. 2. The IOL insertion tool of claim 1, wherein the HOMS comprises a rotatable dial, the user actuation comprises rotating the dial, and the cam mechanism is configured to translate the rotation of the dial into moving one or more arms disposed within the cavity, thereby actively deforming the IOL.

Citation Information

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