RU2806334C2 - Optical-haptic control system using rotary cams - Google Patents

Abstract

FIELD: medical equipment.

SUBSTANCE: invention relates to devices for inserting an intraocular lens into the eye. An exemplary opto-haptic control system may include the first cam assembly comprising the first cam body, a hole in the first cam body, and haptic element folding tabs located in the hole. The opto-haptic control system may further comprise the second cam assembly located on one side of the first cam assembly, wherein the second cam assembly comprises the second cam body, an opening in the second cam body, and optical element folding elements located in the hole. The opto-haptic control system may further comprise a central plate for retaining the intraocular lens in the hole of the second cam body, the central plate being disposed between the first cam assembly and the second cam assembly.

EFFECT: obtaining optical-haptic control system using rotary cams.

14 cl, 14 dwg

Description

BACKGROUND OF THE INVENTION

[0001] The human eye can suffer from a number of diseases, causing from slight impairment to complete loss of vision. While contact lenses and glasses can compensate for some conditions, others may require eye surgery. In general, ophthalmic surgery can be classified into posterior segment procedures, such as vitreoretinal surgery, and anterior segment procedures, such as cataract surgery. Vitreoretinal surgery can be used to treat a variety of 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, surgery may require incisions and insertion of instruments into the eye to replace the cloudy natural lens with an intraocular lens ("IOL"). A large incision site may result in a longer recovery time after surgery. To reduce this recovery time, typical surgical procedures have shifted to making approximately 2 millimeter incisions in the eye. Although this reduced incision size may reduce recovery time after surgery, as the incision size decreases, issues such as the size and functionality of the insertion tool may arise. Typically, the insertion tool may be pre-charged with an IOL that can be inserted into the patient's eye after removal of the opacified natural lens. The insertion tool may include a piston for pushing the IOL out of the nose of the insertion tool. The piston may have additional functions including haptic folding and IOL folding. Once the incision is made, the insertion tool can be inserted into the eye through the incision and the folded IOL can be dispensed into the eye by activating the plunger. As the incision site decreases, the size of the insertion instrument tip may decrease accordingly.

SUMMARY OF THE INVENTION

[0003] In an illustrative aspect, the present invention relates to an opto-haptic control system. The opto-haptic control system may include a first cam assembly comprising a first cam body, an opening in the first cam body, and haptic element folding tabs located in the opening. The opto-haptic control system may further comprise a second cam assembly located on one side of the first cam assembly, wherein the second cam assembly comprises a second cam body, an opening in the second cam body, and optical element folding elements located in hole. The opto-haptic control system may further comprise a central plate for retaining the intraocular lens in an opening of the second cam body, the central plate being disposed between the first cam assembly and the second cam assembly.

[0004] In another illustrative aspect, the present invention relates to an insertion tool. The insertion tool may comprise a drive system, wherein the drive system comprises a housing. The insertion tool may further comprise a piston positioned at least partially within the drive system. The insertion tool may further comprise a spout. The insertion tool may further comprise an opto-haptic control system located between the drive system and the spout for receiving the distal tip of the plunger. The opto-haptic control system may include a first cam assembly comprising a first cam body, an opening in the first cam body, and haptic element folding tabs located in the opening. The opto-haptic control system may further comprise a second cam assembly located on one side of the first cam assembly, wherein the second cam assembly comprises a second cam body, an opening in the second cam body, and optical element folding elements located in hole. The opto-haptic control system may further comprise a central plate for retaining the intraocular lens in an opening of the second cam body, the central plate being disposed between the first cam assembly and the second cam assembly.

[0005] In another illustrative aspect, the present invention relates to a method for delivering an intraocular lens. The method may include rotating the first cam assembly to push the intraocular lens haptic elements over the intraocular lens optical element. The method may include further rotating the first cam assembly such that the first cam assembly engages the second cam assembly, causing the second cam assembly to rotate in engagement with the intraocular lens and causing the intraocular lens optical element to fold. The method may further include operating the drive system to dispense the intraocular lens through the nose and into the eye.

[0006] Various aspects may include one or more of the following features. The opto-haptic control system may further comprise a bottom cover located on an opposite side of the second cam assembly from the first cam assembly, the bottom cover including openings that receive pins that extend from tabs for folding the haptics and about which tabs rotate to folding of haptic elements. The bottom cap may further include a recessed ring and a raised central surface defined by the recessed ring, wherein the recessed ring receives a raised ring formed around the perimeter of the main portion of the second cam. The central plate may further comprise a lens surface and a channel extending at least partially through the lens surface, wherein each of the first pair of guides and the second pair of guides are located on either side of the channel, the channel receiving elements for folding the optical element. Each of the optical element folding members may comprise a body, a tongue extending from the body for engagement with the body of the second cam, and a ramp at an opposite end of the body from the tongue and configured to engage the optical element of the intraocular lens when the second cam is in assembly is actuated, and each of the optical element folding members further comprises projections from opposite sides of the main body, which are located in projection channels formed in at least one of the first pair of guides or the second pair of guides.

[0007] Various aspects may further include one or more of the following features. The first cam body may comprise an outer perimeter and an inner perimeter. The inner perimeter of the first cam body may define an opening in the first cam body and one or more cam surfaces configured to engage the haptic folding tabs when the first cam assembly is actuated. The protruding portion of the cam may extend from the main portion of the first cam at an outer perimeter. The second cam body may comprise an outer perimeter and an inner perimeter. An internal perimeter of the second cam body may define an opening in the second cam assembly and one or more cam surfaces configured to engage members for folding the optical element when the second cam assembly is actuated. A recessed portion may be formed at an outer perimeter of the second cam body. The first cam assembly may be positioned such that a protruding portion of the cam is located in a recessed portion between a first end and a second end of the recessed portion. Each of the haptic folding tabs may have a first end and a second end and include a protrusion at the first end and a pin extending from the second end, wherein the protrusion for each of the haptic folding tabs extends through corresponding holes in the central plate. The protrusion for each of the haptic element folding tabs may be configured to follow one or more cam surfaces formed in the perimeter of an opening in the first cam assembly such that the one or more cam surfaces engage the protrusion to allow rotation of the folding tabs. haptic elements when the first cam assembly is actuated. Each of the first cam assembly and the second cam assembly may be disc-shaped. The intraocular lens may be located on the central plate, wherein the intraocular lens may include an optical element located over a channel formed in the lens surface of the central plate, and wherein the intraocular lens may further comprise haptic elements that extend from the optical element through one or more holes in the central plate.

[0008] Various aspects may further include one or more of the following features. The piston may be configured to engage the intraocular lens when the drive system is actuated to dispense the intraocular lens from the spout. The drive system may comprise a lever and a pneumatic system. The first cam assembly may include a first cam body, an opening in the first cam body, folding tabs for haptic elements located in the opening, and one or more cam surfaces formed in the perimeter of the opening of the first cam body. One or more cam surfaces of the first cam assembly may engage the haptic element folding tabs when the first cam assembly is rotated such that the haptic element folding tabs rotate to push the haptic elements over the optical element. The second cam assembly may include a second cam body, an opening in the second cam body, optical element folding members disposed in the opening, and one or more cam surfaces defined within a perimeter of the opening in the first cam body. One or more cam surfaces of the second cam assembly may engage the optical element folding members when the second cam assembly is rotated such that the optical element folding members can be pushed inward toward each other while engaging the intraocular lens, resulting in folding of the optical element element to yourself. Rotating the first cam assembly may include applying a force to a cam protrusion portion that extends from an outer perimeter of the first cam body such that the cam protrusion portion engages a recessed portion formed in the outer perimeter of the second main portion. Further rotation of the first cam assembly may cause the protruding portion of the cam to abut the end of the recessed portion, which causes rotation of the second cam assembly.

[0009] It should be understood that both the foregoing general description and the following detailed description are illustrative and explanatory in nature and are intended to provide an understanding of the present invention without limiting the scope of the present invention. Accordingly, from the following detailed description, additional aspects, features and advantages of the present invention will become apparent to one skilled in the art.

BRIEF DESCRIPTION OF GRAPHIC MATERIALS

[0010] These drawings depict certain aspects of certain embodiments of the present invention and should not be used to limit or define the present invention.

[0011] In FIG. 1 is a diagram of an exemplary delivery tool configured to deliver an IOL to the eye.

[0012] In FIG. 2A depicts an eye into which an IOL is inserted from an insertion tool.

[0013] In FIG. 2B shows the eye shown in FIG. 2A, in which the IOL is located within the capsular bag of the eye and the insertion tool is removed from the eye.

[0014] In FIG. 3 is a perspective view of another exemplary delivery tool configured to deliver an IOL to the eye.

[0015] In FIG. 4 is a top view of the insertion instrument of FIG. 3.

[0016] In FIG. 5 is a side view of the insertion tool of FIG. 3.

[0017] In FIG. 6 is a detailed view of the distal end of the insertion instrument of FIG. 3.

[0018] In FIG. 7 illustrates exemplary opto-haptic control.

[0019] In FIG. 8 shows the central plate of the optical-haptic control system according to FIG. 7.

[0020] In FIG. 9 shows the first cam assembly of the optical-haptic control system of FIG. 7.

[0021] In FIG. 10 shows the bottom cover of the optical-haptic control system according to FIG. 7.

[0022] In FIG. 11 shows the second cam assembly of the optical-haptic control system of FIG. 7.

[0023] In FIG. 12 shows the optical-haptic control system of FIG. 7, in which the tabs for folding the haptic elements are in the reduced position during its operation.

[0024] In FIG. 13 shows the optical-haptic control system of FIG. 7, in which the elements for folding the optical element are in the reduced position during operation.

[0025] In FIG. 14 depicts a method of preparing an intraocular lens (IOL) for delivery via an IOL delivery tool.

DETAILED DESCRIPTION

[0026] In order to facilitate an understanding of the principles of the present invention, reference will now be made to the embodiments illustrated in the drawings, and specific terminology will be used to describe them. However, it should be understood that no limitations on the scope of the present invention are intended. Any changes and additional modifications to the described devices, tools, methods and any additional applications of the teachings of the present invention are fully contemplated as will be readily apparent to one skilled in the art to which the invention relates. In particular, it is fully contemplated that the features, components and/or steps described with reference to one or more embodiments may be combined with features, components and/or steps described with reference to other embodiments of the present invention. For simplicity, in some cases the same reference numbers may be used in all graphics for the same or similar elements.

[0027] The exemplary embodiments described herein generally relate to ophthalmic surgery. More specifically, the illustrative embodiments generally relate to systems, methods, and devices for inserting an intraocular lens ("IOL") into the eye. Embodiments may include an insertion tool for preparing and delivering the IOL to a patient's eye, which includes a plunger, a spout, and an opto-haptic control system. In some embodiments, the haptic control system may fold the IOL and tuck one or more IOL haptic elements. The haptic element extends from the IOL optical element and stabilizes the IOL when positioned within the capsular bag of the eye. Once the IOL is prepared, a plunger pushes the IOL through the insertion tool and out of the spout.

[0028] In FIG. 1 is a diagram of an insertion tool 100. In some embodiments, the insertion tool 100 may include an actuator system 102, a piston 104, an opto-haptic control system 106 (interchangeably referred to as "HOMS"), and a spout 108. The actuator system 102 may be any system or combination of components configured to actuate into action of the piston 104. For example, the drive system 102 may utilize lever and/or pneumatic systems; manually operated system or component; hydraulic system; or other device configured to drive the piston 104 to advance; partial promotion; or complete delivery of the IOL 110 from the insertion tool 100. The piston 104 is coupled to the drive system 102. The drive system 102 is configured to drive the piston 104. For example, the drive system 102 may be powered, for example, electrically, mechanically, hydraulically, pneumatically, combinations thereof, or some other means. In response to the drive system 102, the piston 104 moves through the HOMS 106. The HOMS 106 may be located between the drive system 102 and the spout 108. In alternative embodiments, the HOMS 106 may be located at other locations within the insertion tool 100. In some embodiments, the HOMS 106 may contain the IOL 110 in an unfolded position.

[0029] The drive system 102 may be any system, component, or group of components configured to drive the IOL 110 through the insertion tool 100. For example, the drive system 102 includes a piston, shown schematically as piston 104 in FIG. 1, which is configured to engage an IOL 110 located within the insertion tool 100 and advance the IOL 110 within the insertion tool 100. In some cases, the piston 104 is configured to release the IOL from the insertion tool 100.

[0030] In some cases, the drive system 102 may be a manually driven system. That is, in some cases, a user applies force to operate the drive system 102. The exemplary drive system 102 includes a piston 104 that is manually engaged directly or indirectly by the user to push the piston 1044 through the insertion tool 100. Upon advancement, the piston 104 engages the IOL 110 and advances the IOL 110 through the insertion tool 100, which may also include releasing the IOL 110 from the insertion tool 100. A non-limiting example of a handheld instrument for IOL insertion is shown in US Patent Application Publication No. 2016/0256316, the entire contents of which are incorporated herein by reference in their entirety. In other embodiments, the drive system 102 may be an automated system. Exemplary automated drive systems are shown in US Pat. No. 8,808,308; US Patent No. 8308736; and US Pat. No. 8,480,555, each of which is incorporated herein by reference in its entirety. Moreover, other automated drive systems within the scope of the present invention are described in US Patent No. 8998983 and US Patent Application Publication No. 2017/0119522, the entire contents of each of which are incorporated herein by reference in their entirety. Although illustrative drive systems are provided as examples, these systems are not intended to be limiting. Conversely, any component, group of components, systems, devices, mechanisms, or combinations thereof configured to promote the IOL 110 are within the scope of the present invention.

[0031] As shown in FIG. 1, IOL 110 is a one-piece IOL that includes an optical element 114 and haptic elements 112 extending from opposite sides of the optical element 114. For example, in the exemplary IOL 110 shown in FIG. 1, haptic elements 112 are located at an angle of 180° with respect to each other along the outer periphery of the optical element 114. However, other types of IOLs are within the scope of the present invention. For example, a composite IOL may also be used, in which the optical element and one or more haptic elements are separate components.

[0032] IOL 110 may have a shape similar to that of the natural lens of the eye (eg, eye 200 shown in FIG. 2A). The IOL 110 can be made from a variety of materials, including, but not limited to, silicone, acrylic and/or a combination thereof. Other materials are also provided. Haptic elements 112 extend from the periphery of the optical element 114 and function to stabilize the IOL 110 when positioned within the eye.

[0033] In some cases, HOMS 106 may be operative to fold haptic elements 112 over optical element 114 and fold optical element 114. For example, HOMS 106 may be operative to fold haptic elements 112 over optical element 114 and fold optical element 114 over or around folded haptic elements 112. IOL 110 is shown in a folded configuration at 116. The folded configuration 116 of optical element 114 may include one or more haptic elements 112 folded relative to optical element 114 and, in some cases, optical element 114 folded relative to one or multiple haptic elements 112. The piston 104 may be advanced through the HOMS 106 after the HOMS 106 has folded the IOL 110. As the piston 104 moves through the HOMS 106, the piston 104 forces the folded IOL 110 out of the HOMS 106. For example, the piston 104 may push the folded IOL 110 in and out of spout 108.

[0034] In FIG. 2A depicts a patient's eye 200 being operated on using the insertion tool 100. As depicted, the insertion tool 100 dispenses the folded IOL 110 into the patient's eye 200. In some embodiments, the 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 cases, the incision may be made in the cornea 209 of the eye 200. The incision 202 may be sized to allow insertion of a portion of the insertion tool 100 for delivery of the folded IOL 110 into the capsular bag 208. For example, in some cases, the size of the cut 202 may be less than about 2000 microns (2 millimeters) in length. In other cases, the cut 202 may have a length of from about 0 microns to about 500 microns, from about 500 microns to about 1000 microns, from about 1000 microns to about 1500 microns, or from about 1500 microns to about 2000 microns.

[0035] After making the incision 202, an 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 is returned to its original unfolded state. condition, and the IOL 110 is installed 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 relative to the eye 200 such that the optical element 114 refracts light toward the retina (not shown). The haptic elements 112 of the IOL 110 engage with 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, and the eye 200 is allowed to recover for a period of time.

[0036] In FIG. 3-5 depict an exemplary delivery tool 100 configured to deliver an IOL to an eye (eg, IOL 110 to eye 200 shown in FIGS. 2A and 2B). As depicted, the insertion tool 100 includes a drive system 102, an opto-haptic control system 106, and a spout 108. The insertion tool 100 may also include a piston, which may be similar to the piston 104 shown in FIG. 1. In some cases, the piston 104 may be actuated to advance the IOL, for example, which may be similar to the IOL 110 shown in FIG. 1, within the insertion tool 100 for introducing and, in some cases, dispensing the IOL 110 from the insertion tool 100.

[0037] As shown in FIG. 3, the drive system 102 includes a housing 302 and an arm 304 that may be pivotally coupled to the housing 302. The spout 108 is coupled to the distal end 308 of the housing 302. The HOMS 106 is located between the housing 302 and the spout 108. In some cases, the spout 108 may be integrally connected to the housing 302. In other cases, the spout 108 may be separate from the housing 302 and may be interconnected to the housing 302. In some cases, HOMS 106 and spout 108 may be formed as a single unit. In other cases, the HOMS 106, spout 108, and body 302 may be formed as a single unit.

[0038] In some cases, housing 302 may have a thin, elongated shape. In some cases, housing 302 may have a first portion 310 and a third portion 312. In some cases, a second portion 312 may be at least partially disposed over the first portion 310. In the example shown, the second portion 312 includes a plurality of slots 314. A plurality of tabs 316 are formed on of the first portion 310 are received in slots 314 for connecting the first portion 310 and the second portion 312. The tabs 316 may form a locking fit with the cutouts 314. However, the housing design 302 of the exemplary insertion instrument 100 shown in FIG. 3-5 is only a non-limiting example. In some cases, housing 302 may be a single, integral piece. In some cases, housing 302 may include one or more cylindrical parts. Moreover, housing 302 may be constructed in any suitable manner from any number of components.

[0039] With reference to FIG. 3-5, the housing 302 also includes raised portions 318, 319, and 320. The raised portions 318, 319, and 320 are shallow depressions formed in the housing 302 to accommodate, for example, one or more fingers of a user. One or more raised portions 318, 319, and 320 may include a textured surface 322 that may provide a user with improved grip and control of the insertion tool 100. As shown in FIG. 3 and 5, the raised portion 318 may include a textured surface 322. However, the scope of the invention is not necessarily limited to this. Instead, the textured surface 322 may include any, all, or none of the raised portions 318, 319, and 320. Likewise, the arm 304 may also include a textured surface 324. However, in some cases, the arm 304 may not include a textured surface.

[0040] As shown in FIG. 3, spout 108 includes a distal tip 326 that defines an opening 328. Spout 108 also includes a flared portion or damage 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 FIG. 2A and 2B, to deliver the folded IOL thereto. Damage protection 330 may include an end surface 332 configured to contact an external surface to limit the depth to which distal tip 326 penetrates the eye 200. In some embodiments, damage protection 330 may be omitted.

[0041] In some embodiments, the insertion tool 100 may be pre-charged. That is, the insertion tool 100 may include an IOL disposed therein when provided to the end user. In some cases, the IOL may be located within the insertion tool 100 in an unfolded state and ready for delivery to the patient. Providing an insertion tool 100 that is pre-charged with the IOL reduces the number of steps that the user must also complete before delivering the IOL to the patient. For example, a pre-charged insertion tool eliminates any steps that would otherwise be required for the user to load the IOL into the insertion tool. With a reduced number of steps, errors and risks associated with delivering the IOL to the patient can be reduced. In addition, the length of time required to deliver the IOL can also be reduced. In some embodiments, the IOL may be precharged in the HOMS 106.

[0042] In FIG. 6 is a close-up view of an exemplary insertion tool 100 with an opto-haptic control system 106. The HOMS 106 may include a first cam assembly 700, a second cam assembly 702, and a bottom cover 1000. The first cam assembly 700 may be located between the second cam assembly 702 and the bottom cover 1000. HOMS 106 is configured to fold the IOL. The folded IOL may be housed in the housing 600 for dispensing from the spout 108. For example, in some cases, the HOMS 106 may be configured to fold the IOL from a relaxed state to a fully folded configuration, as shown, for example, in FIG. 1. During folding, HOMS 106 may tuck or fold the haptic elements 112 over the optical element 114 of the IOL 110, and also fold the edges of the optical element 114 over the tucked haptics 112, catching the haptics 112 and thus placing the IOL 110 in a folded configuration, as shown, for example, in FIG. 1.

[0043] As shown in FIG. 3-6, for example, HOMS 106 has a size commensurate with the size of the insertion tool 100. That is, the HOMS 106 is compact in size to avoid or limit the degree of obstruction of the surgeon's view while inserting the IOL into the eye. However, the scope of the present invention is not limited to this. Instead, in some cases, the size and/or shape of the opto-haptic control system may be selected to be any desired size or shape. In addition, although the HOMS 106 is shown located at the distal end of the insertion tool 100, the opto-haptic control system 106 may be located anywhere within or along the insertion tool 100. In some embodiments, the HOMS 106 may be located between the spout 108 and the drive system 102.

[0044] In the illustrated example of FIG. 3-6 HOMS 106 is located between the distal end 308 of housing 302 and spout 108. In some cases, HOMS 106 may be releasably coupled to spout 108 and/or drive system 102. For example, HOMS 106 may be releasably coupled to housing 302 using fasteners or types of glue. In other embodiments, the HOMS 106 may be attached to the housing 302 via snap-locking 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.

[0045] In FIG. 7 depicts an exemplary opto-haptic control system 106. In the illustrated example, the optical-haptic control system 106 includes a first cam assembly 700, a second cam assembly 702, and a center plate 704. The center plate 704 is located between the first cam assembly 700 and the second cam assembly 702. In the examples, the center plate 704 is located on top first cam assembly 700 concentrically. As depicted, the IOL 110 is located on the lens surface 706 of the center plate 704 in an opening 708 in the second cam assembly 702.

[0046] In FIG. 8 shows 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 be of any suitable size and/or shape. As depicted, the center plate 704 may be disk-shaped since the center plate 704 is generally circular in shape. However, other forms are also provided. For example, but without limitation, the center plate 704 may be shaped such that all or part of the center plate 704 is elliptical, triangular, rectangular, square, hexagonal, and/or combinations thereof. As depicted, the center plate 704 includes a lens surface 706 and an edge 802 around the perimeter of the lens surface 706. In the illustrated example, a channel 804 is formed in the lens surface 706. In some cases, channel 804 extends through the entire lens surface 706. As depicted, channel 804 extends through the center 805 of the lens surface 706 and along the centerline 812 of the lens surface 706. The channel 804 may, for example, be rectangular in cross section, but the channel 804 may otherwise be configured as needed in a particular application.

[0047] The center plate 704 further includes a first pair of rails 806 and a second pair of rails 808. In some embodiments, the first pair of rails 806 and the second pair of rails 806 are located at the edges 810 of the channel 804. The first pair of rails 806 and the second pair of rails 808 may be located on opposite sides of the IOL 110 relative to each other. In some embodiments, the first pair of guides 806 and the second pair of guides 806 are equidistant from the center 805 of the lens surface 706 of the center plate 704. In additional examples, the first pair of guides 806 are symmetrical to the second pair of guides 808 relative to the center 805. In some embodiments, each of the first pair of guides 806 and the second pair of guides 808 may include opposing projections 807. Projections 807 for each of the first pair of guides 806 and the second pair of guides 808 may be on opposite sides of the channel 804. As depicted, projections 807 extend outward from the surface 706 for the lens. In some embodiments, each of the projections 807 for each of the first pair of rails and the second pair of rails 808 may include projection channels 814 facing inward toward the channel 804, as shown in FIG. 8.

[0048] Additionally, the center plate 704 includes a first hole 816 and a second hole 818. In some embodiments, the first hole 816 and the second hole 818 are located on either side of the channel 804. In the examples, each of the first hole 816 and the second hole 818 includes a first end 820 and second end 822. In some cases, the first hole 816 and the second hole 818 may be moved through the center line 812 and channel 804.

[0049] The central plate 704 supports the IOL 110. As depicted, the IOL 110 is located on the central plate 704 and is supported by the lens surface 706. IOL 110 includes haptic elements 112 and an optical element 114. In some embodiments, the optical element 114 is located across the channel 804 in the lens surface 706 with the edges 824 of the optical element 114 at least partially located on the lens surface 706. The haptic elements 112 extend from the optical element 114 through a first opening 816 and a second opening 818. As depicted, one of the haptic elements 112 extends through the first opening 816, while the other of the haptic elements 112 extends through the second opening 818.

[0050] In FIG. 9 shows 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 be of any suitable size and/or shape. As depicted, the first cam assembly 700 may be ring-shaped because the center plate is generally ring-shaped. However, other forms are also provided. In the illustrated example, the first cam assembly 700 includes a first cam body 900 that includes a hole 902. The first cam body 900 further includes an inner perimeter 904 that defines the hole 902 and an outer perimeter 906. The diameter of the hole 902 is uneven such that the diameter varies along the inner perimeter 904 defining one or more cam surfaces 905. In the illustrated embodiment, the inner perimeter 904 defines two of the cam surfaces 905, but it is contemplated that there may be more or less than two cam surfaces 905. The first cam assembly 700 further includes a raised a ring 908 along the outer perimeter 906 of the first cam body 900. The raised ring 908 may be raised, for example, relative to the lens surface 706. The raised ring 908 may have any suitable thickness and any suitable height above and/or below the lens surface 706. The first cam assembly 700 further includes a protruding cam portion 910. In the illustrated example, the cam protrusion 910 is located on the outer perimeter 906 and extends from the raised ring 908.

[0051] In some embodiments, the first cam assembly 700 further includes folding tabs 912 for haptic elements located in the opening 902. When activated (described in more detail below), the folding tabs 912 cause the haptic elements 112 to fold (e.g., with reference to Fig. 7) on top of the optical element 114 (for example, with reference to Fig. 7). Each of the haptic element folding tabs 912 includes a first end 914 and a second end 916. A pin 918 extends from the second end 916. The pin 918 fits into openings formed in the bottom cover (for example, openings 1006 in the bottom cover 1000 shown in FIG. 10 ). The haptic folding tabs 912 are rotatable about the pin 918 because the pin 918 is a fixed component of the haptic folding tabs 912 on which the haptic folding tabs 912 rotate. The haptic folding tabs 912 also include a protrusion 920 at the second end 916. The protrusion 920 is configured to engage the haptic element 112 (eg, with reference to FIG. 7) of the IOL 110 (eg, shown in FIG. 1). Protrusion 920 includes a platform 922 and a haptic element engagement surface 924. The platform 922 accommodates the haptic elements 112 of the IOL 110 (eg, with reference to FIG. 7).

[0052] In some embodiments, an operator applies a force to the first cam assembly 700 (either directly or indirectly), which causes the first cam assembly 700 to rotate. The first cam assembly 700 may rotate about a transverse axis 926 passing through the center 928 of the first cam assembly 700. As depicted, the first cam assembly 700 can be rotated in the direction indicated by arrow 930. Although arrow 930 indicates counterclockwise rotation, it is also provided that the first cam assembly 700 can also be configured to rotate clockwise arrow. The projections 920 of the haptic element folding tabs 912 move along the inner perimeter 904. The diameter of the inner perimeter 904 varies at a given location. As the diameter of the inner perimeter 904 changes, the protrusions 920 follow the profile of the inner perimeter 904. In some embodiments, in which the opening 902 may be elliptical in shape, the protrusions 920 move from the larger diameter portion of the inner perimeter 904 to the reduced diameter portion, i.e., the protrusions 920 follow one or more cam surfaces 905 as tabs 912 rotate to fold the haptics.

[0053] In FIG. 10 shows a bottom cap 1000. The bottom cap 1000 may be made of materials such as, for example, metals, non-metals, polymers, ceramics, and/or combinations thereof. The bottom cover 1000 may be of any suitable size and/or shape. As depicted, the bottom cap 1000 may be disc-shaped since the bottom cap 1000 is generally circular in shape. However, other forms are also provided. For example, but without limitation, the bottom cover 1000 may be shaped such that all or a portion of the bottom cover 1000 is elliptical, triangular, rectangular, square, hexagonal, and/or combinations thereof. In examples, the bottom cap 1000 includes a recessed ring 1002. The recessed ring 1002 may be located at any suitable distance from the center of the bottom cap 1000. As depicted, the recessed ring 1002 defines a raised center surface 1004. In some cases, the recessed ring 1002 of the bottom cap 1000 accommodates the raised ring 908 (e.g., as shown in FIG. 9) of the first cam assembly 700. In some embodiments, one or more openings 1006 are formed in the raised central surface 1004 of the bottom cover 1000. The one or more openings 1006 may receive pins 918 of the haptic folding tabs 912 elements (for example, as shown in Fig. 9). One or more openings 1006 may be located in any suitable manner anywhere on the bottom cover 1000. In some embodiments, the bottom cover 1000 also includes a protrusion 1008. The protrusion 1008 may be of any suitable size and/or shape. For example, but without limitation, protrusion 1008 may be shaped such that all or part of protrusion 1008 may have a cross-sectional shape that is circular, elliptical, triangular, rectangular, square, hexagonal, and/or combinations thereof. The protrusion 1008 is configured to align the bottom cover 1000 with respect to the first cam assembly 700 and the second cam assembly 702.

[0054] In 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 be of any suitable size and/or shape. The second cam assembly 702 may be of any suitable size and/or shape. As depicted, the second cam assembly 702 may be ring-shaped because the center plate is generally ring-shaped. However, other forms are also provided. In embodiments, the second cam assembly 702 includes a second cam body 1100 that includes an opening 708. The second cam body 1100 includes an inner perimeter 1102 that defines the opening 708 and an outer perimeter 1104. The diameter of the opening 708 is uneven such that the diameter varies along an inner perimeter 1102 defining one or more cam surfaces 1105. In the illustrated embodiment, the inner perimeter 1102 defines two of the cam surfaces 1105, but it is contemplated that there may be more or less than two cam surfaces 1105. The second cam assembly 702 includes a recessed portion 1106 in the outer perimeter 1104. The recessed portion 1106 serves to actuate the second cam assembly 702. The recessed portion 1106 may be a portion of the second cam assembly 702 that is free of material along the outer perimeter 1104. For example, the recessed portion 1106 includes a first end 1108 and a second end 1110 that define the arc length of the recessed portion 1106.

[0055] As depicted, the second cam assembly 702 further includes optical element folding elements 1112 located in the opening 708. In some cases, there may be a plurality of optical element folding elements 1112. In the illustrated example, two of the optical element folding elements 1112 are located in the opening 708. The optical element folding elements 1112 are movable along the inner perimeter 1102 of the opening 708 and in a channel 804 (for example, shown in FIG. 8) formed in the surface 706 for the lens of the center plate 704. In some embodiments, each of the optical element folding elements 1112 may be configured to follow one or more cam surfaces 1105. For example, each of the optical element folding elements 1112 may be configured to follow a corresponding one of the cam surfaces 1105. Because the inner perimeter 1102 has a variable diameter, the optical element folding elements 1112 must move toward the center 1103 of the second cam assembly 702 as they follow one or more surfaces. The optical element folding elements 1112 may be made of materials such as, for example, metals, non-metals, polymers, ceramics, and/or combinations thereof.

[0056] In some embodiments, each of the optical element folding members 1112 includes a tongue 1114, a body 1116, projections 1118, and a ramp 1120. The tongue 1114 may extend from the body 1116 opposite the ramp 1120 and engage with the second cam body 1100. The protrusion 1118 may be configured to guide the optical element folding elements 1112 along one or more cam surfaces 1105, being any suitable means of connecting the optical element folding elements 1112 to the second cam body 1100. Protrusions 1118 may extend from both sides of the main body 1116 of each element 1112 for folding the optical element. One of the projections 1118 for each optical element folding element 1112 is obstructed in FIG. 11 as part of the main body 1116. The projections 1118 may slide in the projection channels 814 of the first pair of rails 806 (eg, with reference to FIG. 8) and/or the second pair of rails 808 (for example, with reference to FIG. 8). In examples, the slope 1120 is an arcuate surface located on the opposite side of the body 1116 relative to the tongue 1114. In other embodiments, the slope 1120 may have other shapes. For example, slope 1120 may have a shape other than arcuate. The slope 1120 is configured to engage and fold the optical element 114 (eg, with reference to Fig. 7) when actuating the elements 1112 to fold the optical element.

[0057] Referring now to FIG. 7, 12 and 14, the operation of the optical-haptic control system will be further described. As shown in FIG. 7, IOL 110 is located in the optical-haptic control system 106. The IOL 110 may be in a loose or unfolded state with haptic elements 112 extending from the optical element 114. In the illustrated example, the IOL 110 is located on the central plate 704. The haptic element folding tabs 912 may be partially located through the first hole 816 and the second hole 818 in center plate 704. In the illustrated example, projections 920 of the haptic element folding tabs 912 are located within the first opening 816 and the second opening 818, respectively. As depicted, the projections 920 engage the haptics 112. The cam protrusion portion 910 of the first cam assembly 700 is located in the recessed portion 1106 of the second cam assembly 702, for example, at the first end 1108 of the recessed portion 1106. In other cases, the cam protrusion portion 910 may otherwise be located in the recessed portion 1106, for example, at the second end 1110.

[0058] Referring now to FIG. 12, examples include actuating the first cam assembly 700 by rotating the first cam assembly 700. In the examples, rotating the first cam assembly 700 actuates the haptic folding tabs 912, allowing the haptic folding tabs 912 to rotate to fold the haptic members. 112 IOL 110 onto the optical element 114. As previously described, haptic element folding tabs 912 follow the inner perimeter 904 (eg, shown in FIG. 9) of the opening 902 (eg, shown in FIG. 9), causing the tabs 912 to rotate. to fold the haptic elements and correspondingly move the protrusions 920. In the illustrated example, the protrusions 920 move from the first end 820 to the second end 822 of the first hole 816 and the second hole 818, respectively, in the central plate 704. As the first cam assembly 700 rotates, the protruding portion 910 cam moves along the recessed portion 1106. In some embodiments, the protruding cam portion 910 may move from the first end 1108 of the recessed portion 1106 to the second end 1110 of the recessed portion 1106. In some embodiments, the first cam assembly 700 may rotate approximately 90°, resulting in moving the cam extension 910 from the first end 1108 to the second end 1110. In other cases, the first cam assembly 700 may rotate through other distances, for example, the first cam assembly 700 may rotate through an angle greater than or less than 90°.

[0059] Referring now to FIG. 13, examples include actuating the second cam assembly 702, for example, by continuing to rotate the first cam assembly 700. In the examples, the first cam assembly 700 abuts the second cam assembly 702 as the first cam assembly 700 continues to rotate. For example, the protruding cam portion 910 engages the second end 1110 of the recessed portion 1106 to abut the second cam assembly 702, causing the second cam assembly 702 to rotate. In some embodiments, the optical element folding elements 1112 are located in an opening 708 formed in a second cam assembly 702, and a channel 804 formed in the lens surface 706 of the center plate 704. As the second cam assembly 702 rotates, the optical element folding elements 1112 follow one or more cam surfaces 1105 formed in the inner perimeter 1102 of the opening. 708. As the diameter of the hole 708 decreases, the optical element folding elements 1112 move inward along the channel 804 into engagement with the optical element 114. As an example, slopes 1120 (such as those shown in FIG. 11) engage with the optical element 114. The first pair of guides 806 and a second pair of guides 808 guide the optical element folding elements 1112 as they move inward in the channel 804. In some cases, the optical element folding elements 1112 abut the optical element 114, causing the optical element 114 to fold inwardly with the haptic elements 112. located on top of the optical element 114 to fold the IOL 110, for example, into the folded configuration 116 for the IOL 110 shown in FIG. 1. IOL 110 can then be raised or lowered from opening 708 and into housing 600 (eg, shown in FIG. 6). Any suitable method can be used to move the IOL 110 from the opening 708 to the housing 600. A drive system, such as the drive system 102 shown in FIG. 1 can then be used to dispense the IOL 110 from the housing 600. Accordingly, an opto-haptic control system 106, as described herein, can be used to prepare the IOL 110 for insertion into the eye 200 (e.g., shown in FIGS. 2A and 2B).

[0060] In various embodiments, the haptic-optical management system ("HOMS") may be any of a wide variety of systems, devices, components, cartridges, etc. in an intraocular lens (IOL) delivery system that are configured to be IOL for delivery. The HOMS may be located between the spout or tip of the IOL insertion instrument and the piston and/or drive system of the IOL insertion instrument. For example, the HOMS may be a component in a multi-component modular IOL delivery instrument having one or more of a cartridge, a spout component, an actuator component, a piston component, a spout component, a HOMS component, etc. HOMS, as described herein, can be used with either a modular IOL insertion instrument or an IOL insertion instrument having permanently or semi-permanently coupled components. In a modular embodiment, the cartridge component containing the HOMS may be coupled to the drive component. The HOMS may receive activation by a user of the HOMS system to prepare the IOL contained therein for delivery by sequential interaction from a piston and/or actuator.

[0061] As described above, the HOMS may include a system for receiving actuation by a user to prepare the IOL for delivery and may include first and second cam assemblies for folding and/or folding the IOL haptic elements over the IOL optical element, folding the edges of the optical element over folding haptic elements and/or gripping haptic elements to position the IOL in a folded configuration for insertion through the spout of the IOL delivery device. However, depending on the material of the IOL, the shape of the IOL, the presence or absence of an internal capacitance in the IOL, the material contained in the internal capacitance of the IOL, etc., the HOMS can be configured to receive user actuation to deform the IOL in a wide variety configurations in preparation for being pushed through the spout of the IOL delivery device and released from the IOL delivery device.

[0062] As described above, the HOMS can be configured to deform and/or manipulate the haptic elements and/or the IOL optical element so that they assume various configurations. For example, in some cases, the HOMS may be configured to stretch the IOL haptic elements in substantially opposite directions from the optical element. For example, the HOMS may include a cavity for supporting a precharged IOL and a cam mechanism for extending and/or stretching the haptic elements and/or the optical element of the IOL. The cam mechanism can be actuated by the user to actively deform, elongate, stretch, or otherwise fold the IOL elements (e.g., fold a single haptic, fold multiple haptics, deform a single haptic, deform multiple haptics, stretch a single haptic element, stretching of multiple haptic elements, etc.) before the IOL insertion device piston contacts the IOL and before the IOL is advanced into the nose of the IOL insertion instrument. Those skilled in the art, having taken advantage of the present invention, will readily understand that a wide variety of deformations are possible and can be achieved using the designs and principles described herein.

[0063] Although specific examples of cam assemblies are described above, for the purpose of the present invention, a cam can be any rotary or sliding component designed to convert rotary motion into linear motion for manipulating one or more components of the IOL (e.g., deforming, elongating, stretching or folding IOL elements). The cam assembly may be actuated by the user through any suitable mechanism, including rotation or rotation of the dial, cap, or wheel on the IOL insertion tool. Alternatively, the cam mechanism may be actuated by manipulation of non-rotary elements (e.g., switch, lever, slider, button, etc.) that are mechanically coupled to the cam mechanism to impart the appropriate rotary motion to deform, elongate, stretch, or otherwise case, folding the IOL elements, as noted above.

[0064] In FIG. 14 depicts a method 1400 of preparing an intraocular lens (IOL) for delivery via an IOL delivery tool as disclosed herein. At step 1405, the drive system of the modular IOL insertion tool may optionally be coupled to an IOL cartridge that contains a precharged IOL and an opto-haptic control system ("HOMS"). At step 1410, the IOL cartridge may optionally be coupled to a spout component of the modular IOL insertion tool. At step 1415, activation by the HOMS user of the IOL insertion tool (eg, by rotating the dial) is transmitted to actively manipulate (eg, deform, elongate, stretch, or otherwise fold) one or more elements of the precharged IOL before advancing the IOL. into the spout component. This transfer may be implemented in any suitable manner, for example as described in the examples above. In some embodiments, the HOMS actively manipulates the IOL so that it assumes a configuration suitable for advancement into the spout before the plunger or spout of the IOL insertion tool contacts any element of the IOL. Thus, the IOL can actively fold or expand to propel itself as a separate user step out of engagement with the drive system and/or piston. At block 1420, user activation of the IOL insertion tool drive mechanism is transmitted to advance the IOL through the nozzle and deliver the IOL to the target (eg, the patient's anterior capsule).

[0065] It is believed that the operation and construction of the present invention will be apparent from the foregoing description. Although the apparatus and methods shown or described above have been described as preferred, various changes and modifications may be made thereto without departing from the spirit and scope of the present invention as set forth in the following claims.

Claims (30)

1. Optical-haptic control system containing: a first cam assembly comprising a first cam body, an opening in the first cam body, and haptic element folding tabs disposed in the opening; a second cam assembly located on one side of the first cam assembly, the second cam assembly comprising: a second cam body, an opening in the second cam body, and optical element folding members disposed in the opening; wherein said elements for folding the optical element are configured to be pushed inwards to fold the intraocular lens, and a central plate for holding the intraocular lens in an opening of the second cam body, the central plate being disposed between the first cam assembly and the second cam assembly. 2. The optical-haptic control system of claim 1, further comprising a bottom cover located on the opposite side of the second cam assembly from the first cam assembly, the bottom cover comprising openings that receive pins that extend from the haptic element folding tabs and around which the legs rotate to fold the haptic elements. 3. The optical-haptic control system of claim 2, wherein the bottom cover includes a recessed ring and a raised central surface formed by the recessed ring, wherein the recessed ring receives a raised ring formed around the perimeter of the main portion of the second cam. 4. The optical-haptic control system of claim 1, wherein the central plate comprises a lens surface and a channel extending at least partially through the lens surface, wherein each of the first pair of guides and the second pair of guides is located on either side of the channel, the channel accommodates elements for folding the optical element. 5. The optical-haptic control system according to claim 4, in which each of the elements for folding the optical element contains a main part, a tongue extending from the main part for engagement with the main part of the second cam, and a slope at the opposite end of the main part from the tongue, made capable of engaging with the optical element of the intraocular lens when the second cam assembly is actuated, and wherein each of the optical element folding members further comprises projections from opposite sides of the main body that are located in projection channels formed in at least one from the first pair of guides or the second pair of guides. 6. Optical-haptic control system according to claim 1, wherein the first cam body comprises an outer perimeter and an inner perimeter; wherein the inner perimeter of the first cam body defines an opening in the first cam body and one or more cam surfaces configured to engage the haptic folding tabs when the first cam assembly is actuated; wherein the protruding portion of the cam extends from the main portion of the first cam at an outer perimeter; wherein the main part of the second cam comprises an outer perimeter and an inner perimeter; wherein the inner perimeter of the second cam body defines an opening in the second cam assembly and one or more cam surfaces configured to engage members for collapsing the optical element when the second cam assembly is actuated; wherein the recessed part is formed in the outer perimeter of the main part of the second cam; And wherein the first cam assembly is positioned such that a protruding portion of the cam is located in a recessed portion between the first end and the second end of the recessed portion. 7. The optical-haptic control system of claim 1, wherein each of the haptic element folding tabs has a first end and a second end and includes a protrusion at the first end and a pin extending from the second end, wherein a protrusion for each of the folding tabs haptic elements pass through corresponding holes in the central plate. 8. The optical-haptic control system of claim 7, wherein the protrusion for each of the haptic element folding tabs is configured to follow one or more cam surfaces formed in the perimeter of an opening in the first cam assembly such that one or more Multiple cam surfaces engage the protrusion to allow the tabs to rotate to fold the haptics when the first cam assembly is actuated. 9. The optical-haptic control system of claim 1, wherein each of the first cam assembly and the second cam assembly is disc-shaped. 10. The optical-haptic control system according to claim 1, which further comprises an intraocular lens located on the central plate, wherein the intraocular lens contains an optical element located on top of a channel formed in the surface for the lens of the central plate, and wherein the intraocular lens further comprises haptic elements that extend from the optical element through one or more holes in the central plate. 11. An instrument for introducing an intraocular lens (IOL), containing: IOL located inside the cavity; spout; a piston configured to advance the IOL through the spout; And an opto-haptic control system (HOMS) comprising a cam mechanism configured to transmit user actuation to the HOMS to actively deform the IOL before advancing the IOL into the spout, wherein the HOMS is further configured to tuck one or more IOL haptic elements under the IOL optical element and fold one or more edges of the IOL optical element over the one or more tucked IOL haptic elements. 12. The IOL insertion tool of claim 11, wherein the HOMS cam mechanism is further configured to transmit user actuation to the HOMS to actively deform the IOL without contacting the IOL with the spout or piston. 13. The IOL insertion tool of claim 12, wherein the cam mechanism includes one or more tabs, the one or more tabs being movable within the cavity in response to user actuation, resulting in deformation of the IOL. 14. The IOL insertion tool of claim 11, wherein the HOMS is further configured to extend in opposite directions a pair of IOL haptics.

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