Microsurgical device having retractable needle-tipped introducer and methods of use

Abstract

A microsurgical device for ocular surgery comprising a distal portion having an introducer tube comprising an introducer lumen and a distal beveled end defining a distal opening from the introducer lumen, the distal beveled end configured for creating a penetration of the eye; and an interventional tool assembly sized to be received within the introducer lumen. The introducer tube is movable relative to the interventional tool assembly. The interventional tool assembly comprises an outer collar having a blunt distal edge defining a distal opening into the outer collar; and an interventional tool extending through the outer collar, the interventional tool comprising a distal end. The outer collar and / or the interventional tool are movable relative to one another to actuate the interventional tool. Related tools, systems, and methods are provided.

Description

MICROSURGICAL DEVICE HAVINGRETRACTABLE NEEDLE-TIPPED INTRODUCER AND METHODS OF USECROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of priority to U.S. Provisional Application Serial Nos. 63 / 658,775, filed June 11, 2024; 63 / 724,241, filed November 22, 2024; and 63 / 803,297, filed May 9, 2025. The entire contents of the applications are incorporated by reference in their entireties.FIELD

[0002] The present disclosure relates generally to the field of ophthalmology, more particularly to microsurgical devices having retractable needle-tipped introducer and methods of use.BACKGROUND

[0003] Handheld ophthalmic devices are used for a variety of ocular surgical interventions, including anterior segment procedures such as phacoemulsification and intraocular lens (IOL) implantation and fixation, as well as posterior segment procedures such as retinal surgery and vitrectomy. Ocular surgical interventions often involve intraocular manipulation of elements and extemalization of those elements, such as for fixation. As an example, IOL haptics can be externalized and anchored to a scleral surface. The Yamane Technique is an anterior segment surgical technique that involves transconjunctival scleral fixation of a three-piece IOL using thin- walled 30- or 27-gauge needles through two subconjunctival sclerotomies. A first needle is positioned through a first scleral tunnel and instrumentation, such as microforceps, inserted through a paracentesis across from the location of the first scleral tunnel is used to manipulate a first haptic of the IOL. The first haptic of the IOL is fed into the distal opening of the first needle using the instrumentation. The second haptic of the IOL is fed into a distal opening of a second needle inserted through a second scleral tunnel and manipulated using instrumentation inserted through a paracentesis across from the location of the second scleral tunnel. The second haptic is fed into the distal opening of the second needle. The first and second needles are then externalized drawing their respective haptics with them out onto the conjunctival surface of the eye. The ends of the haptics can then be cauterized to anchor the tip of the haptics outside the eye preventing thehaptic from withdrawing back through the scleral tunnels into the posterior chamber. The flanged haptics are then manipulated beneath the conjunctiva and Tenon’s capsule where they sit on the scleral surface, within the sclerotomy, or embedded in a scleral flap. The technique requires multiple penetrations of the eye and necessitates handling of a variety of tools during a single prosecution.

[0004] Intraocular devices are often formed of deformable, elastic, or soft materials that are prone to damage during intraocular manipulations. For example, elastic silicone devices can be inadvertently cut by sharp edges of surgical tools. The need exists for improved instrumentation for ophthalmic surgical interventions.SUMMARY

[0005] In an aspect, disclosed is a microsurgical device for ocular surgery. The microsurgical device includes a proximal portion having a housing for manipulation of the microsurgical device; and a distal portion coupled to and extending distally from the housing. At least a distal end region of the distal portion being sized and shaped for insertion into an eye. The distal portion includes an introducer tube having an introducer lumen and a distal beveled end defining a distal opening from the introducer lumen. The distal beveled end is configured for creating a penetration of the eye. An interventional tool assembly is sized to be received within the introducer lumen. The introducer tube is movable relative to the interventional tool assembly. The interventional tool assembly includes an outer collar having a blunt distal edge defining a distal opening into the outer collar; and an interventional tool extending through the outer collar. The outer collar and / or the interventional tool are movable relative to one another to actuate the interventional tool.

[0006] The penetration of the eye is optionally through a cornea or a sclera and / or a conjunctiva. The penetration can be self-sealing. The penetration can have an incision length that is 0.25 mm to 1.5 mm. The introducer tube can be a 23 gauge, 24 gauge, 25 gauge, 26 gauge, 27 gauge, 28 gauge, 29 gauge, or 30 gauge needle. The introducer tube can be a regular wall, thin wall, extra-thin wall, or ultra-thin wall needle. The distal beveled end can include a tip and a heel. A length from the tip to the heel of the distal beveled end can be 0.5 mm to 10 mm. The tip can be blunt or sharp.

[0007] The housing can include a first actuator designed to axially move the introducer tube relative to the interventional tool assembly. The housing optionally includes a second actuator designed to axially move the outer collar relative to the interventional tool. Thefirst actuator can be movable between a first position and a second position. When the first actuator is in the first position, the introducer tube can be advanced to a distal-most position relative to the interventional tool assembly. The distal-most position of the introducer tube can include the distal beveled end being located distal to the distal end of the interventional tool. The introducer tube can be temporarily locked in the distal-most position upon the first actuator being placed in the first position. When the first actuator is in the second position, the introducer tube can be retracted to a proximal-most position relative to the interventional tool assembly. The proximal-most position of the introducer tube can include the distal beveled end being located proximal to the distal end of the interventional tool. The introducer tube can be temporarily locked in the proximal-most position upon the first actuator being placed in the second position. The introducer tube can be temporarily locked in a plurality of locking positions along a length of the microsurgical device. The introducer tube can be rotatable about a longitudinal axis of the introducer tube.

[0008] The interventional tool assembly can be designed to be fully internalized within the introducer lumen in the first position. The interventional tool assembly can be no greater than about 23 gauge. The interventional tool assembly can include an interventional tool that is designed to cut or to grasp, or both. The interventional tool can be designed to cut comprises a scalpel or scissors. The interventional tool can be designed to grasp comprises a snare or forceps. The interventional tool assembly is removable from the distal portion for replacement by a second interventional tool assembly. The interventional tool can include forceps having two elongated arms terminating in gripping tips, each gripping tip integral with a respective elongated arm. The distal opening of the outer collar can be sized to encircle, at least in part, the two elongated arms. The gripping tips can be urged towards one another upon extension of the outer collar relative to the two elongate arms. The gripping tips can splay away from one another upon retraction of the outer collar relative to the two elongate arms. The gripping tips can be flat, smooth, serrated, end-grasping or arced into a hemispherical shape. The elongate arms can be biased away from one another. The interventional tool can be scissors and have two cutting edges. The two cutting edges can be urged towards one another upon extension of the outer collar relative to the scissors. The two cutting edges can move away from one another upon retraction of the outer collar relative to the scissors.

[0009] The microsurgical device can be part of a system optionally including an injector cartridge and / or an implantable device. The implantable device can be an intraocularlens or a device for supporting the intraocular lens within an eye having impaired or defective native capsular bag support for the intraocular lens.

[0010] In an interrelated aspect, described are methods of using a microsurgical device to perform suturing inside the eye and / or to the sclera. Described are methods of performing trans-scleral fixation of an implantable device. The implantable device can be an intraocular lens or a device for supporting the intraocular lens.

[0011] In an interrelated aspect, described is an injector cartridge for injecting an implantable device into an eye. The injector cartridge includes a proximal end region having a holding area sized and shaped to receive the implantable device; a distal end region having an injector tip having a lumen extending between a proximal opening and a distal opening. The holding area of the proximal end region is located just proximal to the proximal opening into the lumen. The injector cartridge includes a distal projection extending distally beyond the distal opening of the distal end region.

[0012] The distal end region can be sized to penetrate a cornea and / or a sclera for injection of the implantable device into the eye. The distal projection can maintain continuity of control of the implantable device upon injection of the implantable device out the distal opening of the injector tip. The distal opening can extend between a heel of a bevel of the injector tip and a proximal end region of the distal projection. The distal projection can form a distal-most terminus of the injector cartridge. The distal projection can have a length along a longitudinal axis of the lumen that is from a distal end of the distal opening to the distal-most terminus of the injector cartridge. The length can be about 1 mm to about 10 mm. The distal projection can have a width across the length. The width can be about 0.25 mm to about 3 mm. The width of the distal projection can be substantially equal to or narrower than a width of the distal opening. The distal projection can have a thickness between an upper surface and a lower surface of the distal projection. The thickness can be substantially equal to a wall thickness of the lumen of the injector tip. The thickness can be about 0.05 mm to about 0.5 mm. The distal- most terminus has an atraumatic shape. The atraumatic shape can be round or angled. The distal projection can be flat from side to side or curves. A curvature of the distal projection can be substantially similar to a curvature of a wall of the lumen. The holding area of the proximal end region can be designed to articulate between an open configuration and a closed configuration. An inner diameter of the lumen near the proximal opening can be larger than an inner diameter of the lumen near the distal opening. The injector cartridge can be configured to mate with a handpiece. The handpiece further can include or be configured to receive apushrod that extends at least partially through the lumen of the injector cartridge to deploy the implantable device into the eye. The implantable device can be an intraocular lens, or a device designed to support an intraocular lens.BRIEF DESCRIPTION OF THE DRAWINGS

[0013] These and other aspects will now be described in detail with reference to the following drawings. Generally speaking, the figures are not to scale in absolute terms or comparatively but are intended to be illustrative. Also, relative placement of features and elements may be modified for the purpose of illustrative clarity.

[0014] FIG. 1 is a cross-sectional schematic of an eye having a microsurgical device inserted into the posterior segment of the eye;

[0015] FIG. 2A is a 3-piece intraocular lens having haptics;

[0016] FIG. 2B is the 3-piece intraocular lens of FIG. 2A after cauterization of the haptic tips;

[0017] FIG. 3 illustrates an implantable device for supporting an intraocular lens;

[0018] FIG. 4A is a perspective view of an implementation of a microsurgical device;

[0019] FIG. 4B is a distal view of the microsurgical device of FIG. 4A taken along circle B;

[0020] FIG. 5A is a cut-away side view of the microsurgical device of FIG. 4A illustrating the device in “needle mode”;

[0021] FIG. 5B is a cut-away side view of the microsurgical device of FIG. 5A illustrating the device in “tool mode”;

[0022] FIG. 6A is a partial, side view of the microsurgical device of FIG. 4A illustrating the device in “needle mode” with the introducer tube advanced distally over the interventional tool assembly;

[0023] FIG. 6B is a partial, side view of the microsurgical device of FIG. 6A illustrating the device in “tool mode” with the introducer tube retracted proximally revealing the interventional tool assembly;

[0024] FIG. 7A is a side view of the interventional tool assembly of the microsurgical device of FIG. 6B with the grasper tips separated from one another and the outer collar retracted proximally;

[0025] FIG. 7B is a side view of the interventional tool assembly of FIG. 7A with the grasper tips urged towards one another and the outer collar advanced distally;

[0026] FIG. 8A is a perspective view of an implementation of a microsurgical device incorporating an introducer tube movable relative to an interventional tool assembly;

[0027] FIG. 8B is a detailed view of the microsurgical device of FIG. 8A illustrating the device in “needle mode”;

[0028] FIG. 8C is a perspective view of the microsurgical device of FIG. 8A;

[0029] FIG. 8D is a detailed view of the microsurgical device of FIG. 8C illustrating the device in “tool mode”;

[0030] FIG. 8E is a partially exploded view of the microsurgical device of FIG. 8 A showing the introducer tube assembly uncoupled from the interventional tool assembly;

[0031] FIG. 8F is an exploded view of the microsurgical device of FIG. 8E;

[0032] FIGs. 8G-8I are detailed views of the microsurgical device of FIG. 8A;

[0033] FIG. 8J is a partial perspective view of another implementation of a microsurgical device in “needle mode”;

[0034] FIG. 8K is a partial perspective view of the microsurgical device in FIG. 8J in “tool mode”;

[0035] FIG. 9 is a perspective view of another implementation of a microsurgical device in “tool mode”;

[0036] FIG. 10A is a perspective view of an IOL support device being loaded into an injector cartridge in an open configuration;

[0037] FIG. 10B is a perspective view of the IOL support device loaded into the injector cartridge in the closed configuration;

[0038] FIG. 10C is a perspective view of the IOL support device being urged distally through the injector cartridge with a pushrod;

[0039] FIGs 11A-1 IE illustrate method steps of inserting the IOL support device of FIGs. 10A-10B from the injector cartridge into the eye and externalizing a fixation arm anchor using the devices described herein;

[0040] FIGs. 12A-12C illustrate method steps of externalizing another fixation arm anchor using the devices described herein;

[0041] FIGs. 13A-13C illustrate method steps of externalizing another fixation arm anchor using the devices described herein;

[0042] FIG. 14 illustrates three externalized anchors and an IOL support device positioned within the eye;

[0043] FIGs. 15A-15E are various views of the injector cartridge in an open configuration;

[0044] FIGs. 16A-16C are various views of the injector cartridge supporting an IOL support device within an eye following ejection from the distal opening of the injector tip.

[0045] It should be appreciated that the drawings herein are for illustration only and are not meant to be to scale.DETAILED DESCRIPTION

[0046] The present disclosure relates generally to the field of ophthalmology, more particularly to microsurgical devices having a coaxial, retractable needle-tipped introducer.

[0047] FIG. 1 is a cross-sectional schematic of an eye 5. The lens and capsular bag are not shown. In an implementation, a microsurgical device 100 includes a proximal portion 105 and a distal portion 110. The distal portion 110 is shown in FIG. 1 inserted through the sclera 10 so that a distal end region 112 of the distal portion 110 is located within the vitreous 15. FIGs. 2A-2B show a 3-piece IOL 200 having haptics 205 with ends 207 configured for scleral fixation of the IOL within the eye 5. FIG. 2B show the ends 207 following cauterization. FIG. 3 shows an implantable device 300 for supporting an IOL (IOL support device) within the eye where a native capsular bag support is lacking or impaired. An interrelated IOL support device 300 is also shown in FIGs. 10A-10C and in FIGs. 16A-16C. The implantable device 300 can include a plurality of arms 305 configured for scleral fixation of the device 300 within the eye. Examples of implantable devices are described in detail U.S.Patent No. 11,759,308, U.S. Publication No. 2022 / 0211487, PCT Publication No. WO 2024 / 107942, each of which are incorporated by reference herein. For purposes of simplicity, the device 100 may be described herein in the context of manipulating an arm of an implantable support device 300 or a haptic 205 of an IOL 200, but it should be appreciated that the tools can be used for any of a variety of techniques within the eye, including forceps, snare loops, and cutters.

[0048] Again with respect to FIG. 1, the microsurgical device 100 includes a proximal portion 105 including a housing for manipulation of the device 100. The proximal portion 105 remains outside the eye. The distal portion 110 is coupled to and extends distally from the housing of the proximal portion 105. At least the distal end region 112 of the distal portion 110 is sized and shaped for insertion into an eye. The distal portion 110 can include an introducer tube 115 and an interventional tool assembly 120. The introducer tube 115 includes an introducer lumen 116 and a distal beveled end 117 defining a distal opening 118 from the introducer lumen 116. The introducer tube 115 having the sharpened, distal beveled end 117 forms a needle that is configured to create a penetration, such as an incision, in the eye. The interventional tool assembly 120 is sized to be received within the introducer lumen 116. The introducer tube 115 and the interventional tool assembly 120 are movable relative to one another. For example, the introducer tube 115 can move relative to the interventional tool assembly 120 or the interventional tool assembly 120 can move relative to the introducer tube 115 or each can be movable relative to one another.

[0049] The interventional tool assembly 120 can include an interventional tool 125 and an outer collar 130 (see FIG. 4B, FIGs. 7A-7B, FIGs. 8A-8K, and FIG. 9). The outer collar 130 has a blunt distal edge 132 that defines a distal opening 134 into the outer collar 130. The interventional tool 125 can extend through the outer collar 130. In some implementations, the outer collar 130 can be in the form of a cannula having an internal lumen within which the interventional tool 125 extends. The outer collar 130 can be formed as merely a distal segment on an elongate control element that is not fully tubular such that the elongate control element and the proximal end region of the interventional tool 125 extend next to one another along the introducer lumen 116. The outer collar 130 and / or the interventional tool 125 can be movable relative to one another to actuate the interventional tool 125.

[0050] FIG. 4A is a perspective view of a microsurgical device 100 and FIG. 4B is a detailed view of the distal end region 112 of the microsurgical device of FIG. 4A taken atcircle B. FIG. 4B shows the interventional tool assembly 120, including the interventional tool 125 and the outer collar 130, exposed distal of the distal opening 118 of the introducer tube 115. The introducer tube 115 in any of the implementations described herein can be a needle sized to penetrate the eye. In some implementations, the needle is a thin wall, extra-thin wall, or ultra-thin wall needle. For example, the penetration can be through the cornea, the sclera, the conjunctiva, or other region. The introducer tube 115 can vary in size (e.g., 23 gauge, 24 gauge, 25 gauge, 26 gauge, 27 gauge, 28 gauge, 29 gauge, or 30 gauge). In some implementations, the introducer tube 115 is sized to ensure the penetration is self-sealing without any suturing. The penetration can have an incision length that is about 0.25 mm to about 1.5 mm. The introducer tube 115 can include a distal beveled end 117 having a tip 119 and a heel 121. The length from the tip 119 to the heel 121 can vary, for example, from about 0.5 mm to about 10 mm. The tip 119 can be sharp to create the penetration without prior puncture, coring, or cutting.

[0051] The introducer tube 115 can be movable relative to the interventional tool assembly 120. FIGs. 5A-5B, FIGs. 6A-6B, and also FIGs. 8A-8K illustrate the movement of the introducer tube 115 relative to the interventional tool assembly 120. FIGs. 5A, 6A, and 8A illustrate the introducer tube 115 in a first position with the introducer tube 115 in a “needle mode” and advanced to a distal-most position relative to the interventional tool assembly 120. FIGs. 5B, 6B, 8C, and also FIG. 9 illustrate the introducer tube 115 in a second position with the introducer tube 115 in a “tool mode” and retracted to a proximal position relative to the interventional tool assembly 120, such as proximal to the blunt distal end of the outer collar 130. The proximal portion 105 can incorporate at least a first actuator 106 that is designed to axially move the introducer tube 115 relative to the interventional tool assembly 120. The first actuator 106 can be toggled between the first position and the second position to move the introducer tube 115 between the “needle mode” and the “tool mode”, respectively. When the introducer tube 115 is advanced to the distal-most position relative to the interventional tool assembly 120 for “needle mode”, the distal beveled end 117 is located distal to the distal end 127 of the interventional tool 125. When the introducer tube 115 is retracted to a proximal position relative to the interventional tool assembly 120 for “tool mode”, the distal beveled end 117 is located proximal to the distal end 127 of the interventional tool 125 extending distal to the distal opening 118 of the tube 115.

[0052] The introducer tube 115 can be temporarily locked in the distal-most position upon the first actuator 106 being placed in the first position so that the interventional tool assembly 120 is fully contained within the introducer lumen 116 allowing the distal beveled end 117 of the introducer tube 115 to be used to penetrate the eye without inadvertently retracting proximally. The locking of this distal-most position is temporary in that once the distal beveled end 117 of the introducer tube 115 penetrates the eye and the distal end region 112 of the device 100 is positioned as desired, the introducer tube 115 can be retracted to expose the interventional tool assembly 120. The introducer tube 115 can be temporarily locked in the proximal position upon the first actuator 106 being placed in the second position. The interventional tool assembly 120 is then ready to be used within the eye to perform a procedure without risk of the sharp tip of the introducer tube 115 interfering with the tool 125.

[0053] The introducer tube 115 can be repeatedly, temporarily locked in the different modes or positions depending on what process is to be performed by the interventional tool assembly 120. This allows for the device 100 to be used repeatedly for performing multiple manipulations during a single surgery in the eye. The procedure performed by the interventional tool assembly 120 can vary and is not intended to be limiting. For example, the procedure can include grasping an IOL haptic, the fixation arm 305 of an implantable device 300, or the footplate of a fixation arm 305 of an implantable device 300 for externalizing the grasped element through a trans-scleral opening. The procedure can include retina manipulations or any of a variety of procedures in the anterior or posterior segments of the eye. The advantage is that the procedure can be performed by the interventional tool 125 without the sharp, distal beveled end 117 of the introducer tube 115 being near the location of the procedure and causing inadvertent damage. The sharp edge of the coaxial introducer tube 115 is not a part of the interventional tool assembly 120 and can be retracted away from the tool assembly 120. Thus, actuating the tool assembly 120 is independent of the sharp edge of the introducer tube 115 and well away from the sharp tip 119. The tool assembly 120 can be fully atraumatic for grasping the IOL or another component that a surgeon desires.

[0054] Again with respect to FIGs. 5A-5B and FIGs. 6A-6B, the proximal portion 105 of the microsurgical device 100 can include an inner shuttle 140 sized to be received within and movable relative to an outer housing portion 145. One half of the outer housing portion 145 is removed from the figures to reveal the inner shuttle 140 relative to thesecond half of the outer housing portion 145. The inner shuttle 140 can be fixedly coupled to the introducer tube 115 projecting distally from a nose cone 142 of the inner shuttle 140. The nose cone 142 and introducer tube 115 can, in turn, be operatively coupled to the first actuator 106. Actuation of the first actuator 106 can slide the inner shuttle 140 distally to extend the introducer tube 115 relative to the interventional tool assembly 120 and the outer housing portion 145 (see FIGs. 5A and 6A) and slide the inner shuttle 140 proximally to retract the introducer tube 115 relative to the interventional tool assembly 120 and the outer housing portion 145 (see FIGs. 5B and 6B).

[0055] In an embodiment as shown in FIGs. 5A-5B and FIGs. 6A-6B, the first actuator 106 includes a flexible beam 146 positioned on a surface of the inner shuttle 140 having at a distal end region a first locking flange 147a. The first locking flange 147a is sized and shaped to extend through a corresponding opening 144a in the outer housing portion 145. The first locking flange 147a can be positioned on the flexible beam 146 so that when the introducer tube 115 is extended to its distal-most position as shown in FIGs. 5 A and 6A, the first locking flange 147a extends up through the opening 144a in the outer housing portion 145 thereby temporarily locking the introducer tube 115 in the “needle mode”. To retract the introducer tube 115, a projection 143a on the flexible beam 146 near the first locking flange 147a can be urged downward, which in turn moves the first locking flange 147a out from engagement with the opening 144a in the outer housing portion 145 as the beam 146 of the inner shuttle 140 flexes inward. This releases the temporary lock provided by the first locking flange 147a and the opening 144a. Once released, the inner shuttle 140 can slide rearward relative to the outer housing portion 145 towards its proximal position using the projection 143a as a slider. The nose cone 142 retracts further into the distal opening 141 of the outer housing portion 145 (see FIGs. 5B and 6B). The flexible beam 146 can have at a proximal end region a second locking flange 147b that is sized and shaped to extend through a corresponding opening 144b in the housing portion 145 at a location proximal to the opening 144a for the first locking flange 147a. The second locking flange 147b can be positioned on the flexible beam 146 so that when the introducer tube 115 is retracted to its proximal-most position as shown in FIGs. 5B and 6B, the second locking flange 147b extends up through the opening 144b in the outer housing portion 145 thereby temporarily locking the introducer tube 115 in the “tool mode”. To once again extend the introducer tube 115, a second projection 143b on the flexible beam 146 that is near the second locking flange 147b can be urged downward, which moves the second locking flange 147b out from engagement with the opening 144b in the outerhousing portion 145 as the beam 146 of the inner shuttle 140 flexes inward. This releases the temporary lock provided by the second locking flange 147b and the opening 144b. Once released, the inner shuttle 140 can slide distally relative to the outer housing portion 145 towards its distal-most position using the projection 143b as a slider. The nose cone 142 extends further out the distal opening 141 of the outer housing portion 145 (see FIGs. 5A and 6A). The locking mechanism for the introducer tube 115 can have a plurality of locking positions. Additionally, the introducer tube 115 can be rotatable about a central longitudinal axis of the introducer tube 115, relative to the actuating tool assembly 120 and or the handpiece 145.

[0056] Each of the embodiments of the microsurgical device in FIG. 4A, FIGs. 6A-6B, FIGs. 8A-8K, and FIG. 9 is shown with a first actuator 106 that is a push-button slider and a second actuator 108 that is a basket design. However, the configuration of the actuators 106, 108 can vary from what is illustrated. The first actuator 106 can vary in configuration, including a slider, button, knob, basket design, wing design, or other sort of feature configuration to slide the introducer tube 115 between modes. The first actuator 106 that toggles the introducer tube 115 between modes is fully independent of the actuation of the interventional tool assembly 120.

[0057] As mentioned above, the interventional tool assembly 120 includes an interventional tool 125 and an outer collar 130. The outer collar 130 of the interventional tool assembly 120 is preferably blunt tipped so that the wall of the outer collar 130 that forms the distal opening 134 that encircles the region of the interventional tool 125 nearest the tips 128 to actuate the tool assembly 120 is atraumatic or a non-cutting surface and thereby avoids inadvertent cutting or damage to the item being manipulated by the tips 128.

[0058] The interventional tool 125 of the interventional tool assembly 120 preferably includes tools designed to cut or grasp or another action or a combination of grasping and cutting for use in the eye. However, the interventional tool 125 of the interventional tool assembly 120 can vary, including, devices such as membrane peel tool, laser, diathermy probe, endoscope, endo-illumination probe, vitrector, fiber optic, gradient index (GRIN) lenses, ultrasonic probe, electromagnetic energy delivery probe, and magnetic pulse probe. The interventional tool assembly 120 can be sized to be fully internalized within the introducer lumen 116 of the introducer tube 115 and is preferably no greater than about 23 gauge. In some implementations, the interventional tool 125 is designed to grasp and is in theform of a snare loop or forceps or other grasping element. In other implementations, the interventional tool 125 is designed to cut and is in the form of a scalpel or scissors or another cutting element. The interventional tool assembly 120 can be removed from the distal portion 110 of the device 100 and, once detached from the device 100, replaced by another interventional tool assembly 120. The proximal portion 105 can thus become a universal hand piece with various interventional tool assemblies 120 that made with the distal portion 110 for use in a variety of procedures in the eye.

[0059] In an implementation, the interventional tool 125 can include forceps having elongated arms 126 terminating in gripping tips 128 (see FIGs. 4B, 7A-7B, and 9). Each gripping tip 128 can be integral with a respective elongated arm 126. The distal opening 134 of the outer collar 130 can be sized to encircle, at least in part, the elongated arms 126 (most visible in FIG. 9). In some implementation, the interventional tool 125 has a pair of arms 126 biased away from one another so that the gripping tips 128 move away from one another, for example, upon retraction of the outer collar 130, and the gripping tips 128 are urged towards one another, for example, upon extension of the outer collar 130 relative to the elongate arms 126. The gripping tips 128 can have any of a variety of configuration including flat, smooth, serrated, crisscross, serrated, end-grasping, or arced into a hemispherical shape. The tips 128 can be configured into a variety of shapes for a variety of uses including forceps for gripping lens capsule forceps, capsulorhexis forceps, chalazion forceps, cilia forceps, clamps, corneal forceps, dressing forceps, Descemet’s stripping forceps (DSEK or DMEK), femtosecond forceps, fixation forceps, hemostatic forceps, IOL forceps, jeweler forceps, LASIK forceps, muscle forceps, pre-chopper forceps, retinal forceps, suturing forceps, tissue forceps, tying forceps, utility forceps.

[0060] In another implementation, the interventional tool 125 can include tips 128 that are designed for cutting. Each tip 128 can be integral with a respective elongated arm 126 as with the grasping tips that can move toward and away from one another, such as upon movement of the outer collar 130 relative to the elongate arms 126. The tips 128 designed for cutting can have any of a variety of configuration including scissoring blades, scalpel blades, or other type of cutting element. The cutting edges of scissoring blades can be urged towards one another upon extension of the outer collar 130 relative to the tips 128. The cutting edges of the scissoring blades can move away from one another upon retraction of the outer collar 130 relative to the tips 128.

[0061] The interventional tool 125 and the outer collar 130 can be movable relative to one another. Actuation of the interventional tool assembly 120 can cause the outer collar 130 to move relative to the interventional tool 125 to cause the tips 128 to perform an intended function. As discussed in detail above, the proximal portion 105 can include a first actuator 106 for moving the introducer tube 115 relative to the interventional tool assembly 120. The proximal portion 105 can include a separate, second actuator 108 that is designed to actuate the interventional tool assembly 120 independent of the introducer tube 115 and its actuator 106 (see FIGs. 1, 4A, 6A, 8A, 8 J, and 9). The configuration of the second actuator 108 can vary, including a slider, button, knob, basket design or a wing design or other sort of feature configuration to cause movement of the tips 128.

[0062] FIG. 4A and also FIGs. 6A-6B illustrate the first actuator 106 as a pushbutton slider and the second actuator 108 that is a wing design. The wing design can incorporate two wings 150a, 150b positioned 180-degrees apart around the circumference of the outer housing portion 145. The wings 150a, 150b can be squeezed toward one another to actuate the interventional tool assembly 120. The wings 150a, 150b can couple to the outer collar 130 via a hinge mechanism so that as the wings 150a, 150b move inward, the outer collar 130 is urged distally over the interventional tool 125 to move the tips 128. The tips 128 can be urged by the collar 130 toward one another closing the tips 128 for gripping or cutting as the distal opening 134 of the collar 130 approaches the distal tips 128. The wings 150a, 150b can be biased outward so that upon release of a squeezing force, the wings move outward away from the center of the device 100 retracting the collar 130 proximally away from the tips 128 of the interventional tool 125 allowing the tips 128 to spring open again. Reverse actuation is also considered herein.

[0063] The relative positioning of the actuators 106, 108 can vary. Generally, the first actuator 106 and second actuator 108 can be arranged relative to the device 100 so that they do not interfere with one another during actuation. For example, FIGs. 4A and 6A-6B and also FIG. 9 show the first actuator 106 and the second actuator 108 are off-set by 90 degrees around the circumference of the housing from one another with the first actuator 106 on an upper surface of the outer housing portion and the second actuator 108 projecting from the two side surfaces of the outer housing portion. In some implementations, rather than being offset around a circumference of the housing, the actuators can be offset along the longitudinal axis of the housing. For example, the actuator 106 for the introducer tube 115 can be located distalto or proximal to the actuator 108 for the interventional tool assembly 120. FIGs. 8A-8K illustrate an implementation where the first actuator 106 for the introducer tube 115 is located distal to the second actuator 108 for the tool assembly 112.

[0064] The sliding elements and stationary elements of retractable introducer tube mechanism can be positioned distal to the second actuator 108 for the interventional tool assembly 120. The stationary elements may be integrated into a portion of the interventional tool assembly 120 that is distal to the second actuator 108 and proximal to the tips 128 and at least a portion of the slidable component is located distal to the stationary element of retractable introducer tube mechanism. The relative movement of the slidable element to the stationary element allows the distal beveled end 117 to be presented in both an extended, "needle mode", such as for incision formation and in a retracted, "tool mode". In still further implementations, the first actuator 106 can be part of a first device and the second actuator 108 can be part of a second, independent device used together with the first device. For example, the components of the retractable, needle-tipped introducer tube assembly can be packaged as a separate device from the interventional tool assembly so that the retractable introducer tube assembly forms a fully-functional, independent "secondary device” that is used together with a fully-functional, independent interventional tool assembly. The arrangement of the actuators shown in FIGs. 8A-8K can be incorporated into any of the other implementations illustrated herein, including the devices described and shown with respect to FIGs. 1, 4A-4B, 5A-5B, 6A- 6B, 7A-7B, and 9. Thus, the features described above with respect to the devices shown in 1, 4A-4B, 5A-5B, 6A-6B, 7A-7B, and 9 can be incorporated into the devices shown in FIGs. SASK and vice versa.

[0065] The interventional tool 125 of any of the devices described herein and thus, the tips 128 of the interventional tool 125 can vary in configuration to perform any of a number of procedures using the devices and assemblies described herein, including forceps, snare loops, and cutters of various configurations. The tips 128 can be a metal or wire-like structure formed of a rigid material such as stainless steel, titanium, Nitinol, or other metal. Alternatively, the tips 128 can be constructed from a plastic such as polypropylene, polyethylene, Nylon, Gortex, polyimide, PMMA, or other plastic. Alternatively, the tips 128 can be made from an elastomeric material such as flexible acrylics, polyurethane, silicone, SIBS, or other elastomeric polymers of similar mechanical properties.

[0066] The interventional tool assembly 120 can be designed to incorporate a locking feature for the tips 128. The forceps tips 128 can transition from a locked to an unlocked and vice versa via any of variety of mechanical motions including twisting, squeezing, sliding, mechanisms that reduce the range of motion of the forceps tips 128 once engaged. In some implementations, the locking forceps has two grasping faces that are locked in a restricted conformation. In other implementations, the forceps has three or four grasping faces that can be locked into a restricted conformation. The locked or restricted conformation may also encase the feature being gripped (i.e., anchor 325 of an implantable device 300 or haptic 205 of an IOL 200) within a sheath that assists in the externalization procedure and limits interference between the item being grasped as it inserts through the sclerotomy. The sheath can define an outermost surface during externalization that can be designed to optimally interact with the ocular tissue. For example, the outermost surface of the sheath can have a profile that is rounded (e.g., circular, elliptical, ovoid, etc.) The sheath may also have a coating to reduce friction with the tissue during externalization. The sheath can be sufficiently rigid so as to substantially retain its shape during externalization.

[0067] Now with respect to FIGs. 8A-8K. FIG. 8A is a perspective view of an interrelated implementation of a microsurgical device 100 incorporating an introducer tube 115 movable relative to an interventional tool assembly 120. The device 100 includes a proximal portion 105 including a housing for manipulation of the device 100. The proximal portion 105 is designed to remain outside the eye and the distal portion 110 has at least a distal end region 112 that is sized and shaped for insertion into the eye. As described elsewhere herein, the introducer tube 115 includes an introducer lumen 116 and a distal beveled end 117 defining a distal opening 118 from the introducer lumen 116. The introducer tube 115 can move relative to the interventional tool assembly 120 or the interventional tool assembly 120 can move relative to the introducer tube 115 or each can be movable relative to one another.

[0068] FIGs. 8A-8B illustrates the device 100 with the introducer tube 115 in a first position or “needle mode” and advanced to a distal-most position relative to the interventional tool assembly 120. FIGs. 8C-8D illustrate the device 100 with the introducer tube 115 in a second position or “tool mode” and retracted to a proximal position relative to the interventional tool assembly 120, such as proximal to a blunt distal end of the outer collar 130 (see FIG. 8D).

[0069] In some implementations, the retractable, needle-tipped introducer tube 115 and its assembly components are packaged as a separate device from the interventional tool assembly 120 so that the retractable introducer tube assembly forms a fully-functional, independent "secondary device” that is used together with a fully-functional, independent interventional tool. The retractable introducer tube assembly 114 can be designed such that one or more components of the assembly 114 are affixed to or joined with at least a portion of the interventional tool assembly 120, which can be an independent device or part of a microsurgical device 100 as described herein. For example, the retractable introducer tube assembly 114 can be added to an existing commercially-available device, such as a forceps device, so as to convert the existing forceps device from its standard configuration into an incision-forming configuration of the base device. When provided as a separate assembly, the retractable introducer tube assembly 114 can include a stationary fixture 160 that functionally affixes the retractable introducer tube assembly 114 to a portion of the secondary interventional tool assembly 120. A proximal end region of the stationary fixture 160 can couple to the interventional tool assembly 120 and a distal end region of the stationary fixture 160 can couple to a movable element 162. The movable element 162 of the introducer tube assembly 115 can be affixed to the introducer tube 115 such that the introducer tube 115 projects distally from the movable element 162 so that the movable element 162 can movably couple to the stationary fixture 160, which in turn can affix the introducer tube assembly 114 to the interventional tool assembly 120. The stationary fixture 160 of the retractable introducer tube assembly 114 can couple to the secondary interventional tool assembly 120 while leaving the movable element 162 of the retractable introducer tube assembly 114 remains mobile with the desired range of motion to achieve the "needle mode" and "tool mode" as described above.

[0070] FIGs. 8E and 8F show the introducer tube assembly 114 detached from the interventional tool assembly 120. FIG. 8F shows the stationary fixture 160 of the introducer tube assembly 114 detached from the movable element 162 having the introducer tube 115 projecting therefrom. The attachment configuration of the stationary fixture 160 of the retractable introducer tube assembly 114 relative to a distal end region of the interventional tool assembly 120 can vary including press-fit, snap-fit, threaded, glued, bolted, affixed with a set screw, compressed with a locking nut, and other attachment configurations that are able to securely adjoin the retractable introducer tube assembly 114 to the geometry of the secondary device (e.g., interventional tool assembly 120, which can be an independent, commercially- available tool, such as forceps or scissors or a snare, etc.).

[0071] The movable element 162 of the retractable introducer tube assembly 114 can be affixed in a manner that allows it to be stable in the extended position, such as shown in FIGs. 8B and 81 and 8J) sufficient to form a puncture or incision through eye tissues, such as the sclera, with the distal beveled end 117 of the introducer tube 115 coupled to and projecting distally from the movable element 162 when in "needle mode". The movable element 162 of the retractable introducer tube assembly 114 is preferably made stable in one or more retracted positions to reduce the risk of unintentional advancement during operation of the interventional tool assembly 120. The retractable introducer tube assembly 114 can attach to the secondary interventional tool assembly 120 at a location that is distal to the second actuator 108 for the interventional tool assembly 120, proximal to the second actuator 108, or at multiple positions that can be both proximal and distal to the second actuator 108. In the implementation shown in FIGs. 8A-8K, the second actuator 108 for the interventional tool assembly 120 is located proximal to the first actuator 106 for the introducer tube assembly 114. The retractable introducer tube assembly 114 and adjoining structures are arranged relative to the interventional tool assembly 120 in a manner that minimally impacts the operation of the second actuator 108 to perform a method using the interventional tool assembly 114.

[0072] The retractable introducer tube assembly 114 and adjoining structures of the stationary fixture 160 are constructed to be easily and reliably assembled with an interventional tool assembly 120 at a point of use, such as in an operating room setting. For example, the proximal end region of the stationary fixture 160 of the retractable introducer tube assembly 114 and / or the movable element 162 can be shaped in a manner and / or incorporate one or more guiding structures that are designed to assist the surgeon inserting the distal end 126 of the interventional tool 125 into an opening at a proximal end of the lumen 116 of the introducer tube 115 prior to use (see FIG. 8H). The proximal end region and / or a guiding structure of the stationary fixture 160 and / or movable element 162 can be an opening 165 in the shape of a funnel or incorporate a tapered region that has a larger open end to receive the distal end 127 of the interventional tool 125 and a narrower proximal end that directs the interventional tool 125 into the lumen 116 of the introducer tube 115 along axis A.

[0073] The movable elements of the retractable interventional tool assembly 114 can optionally contain one or more alignment features 164 to ensure the introducer tube 115 on the movable element 162 retracts substantially on-axis. FIGs. 8B, 8D, 8G, and 81 illustrate the alignment features 164. In an implementation, the movable element 162 has at least onealignment feature 164 on a proximal end region that is sized and shaped to be received within a corresponding channel 166 along a region of the stationary fixture 160. The movable element 162 preferably includes a plurality of alignment features 164 symmetrically arranged around a circumference of the assembly 114, such as two features positioned 180 degrees apart or three alignment features 164 arranged 120 degrees apart or four alignment features 164 arranged 90 degrees, or other arrangement around a circumference of the assembly 114. In some implementations, the assembly 114 incorporates two alignment features 164 arranged 180 degrees apart that are interspersed by one or more features of the first actuator 106. As best shown in FIGs. 8G-8I, the movable element 162 has a proximal end region formed by two alignment features 164 configured to be slidably received within corresponding channels 166 in the stationary fixture 160. Components of the actuator 106 are arranged 90 degrees away from the alignment features 164.

[0074] As discussed above with respect to FIGs. 5A-5B and 6A-6B and others, the actuator 106 to move the introducer tube 115 between “needle mode” and “tool mode” can be temporarily, repeatedly locked in a distal-most position or in “needle mode” and / or temporarily locked in a proximal-most position or in “tool mode”. The movable element 162 of FIGs. 8A-8K can be temporarily locked relative to the tool 125 in a retracted position (“tool mode”) and an extended position (“needle mode”) using features that are designed to engage with corresponding features on the stationary fixture 160 and / or tool 125. Actuation of the first actuator 106 in a distal direction slides the movable element 162 distally to extend the introducer tube 115 relative to the tool assembly 120 and to the stationary fixture 160. Actuation of the first actuator 106 in a proximal direction slides the movable element 162 proximally to retract the introducer tube 115 relative to the tool assembly 120 and to the stationary fixture 160. The first actuator 106 can include a pair of flexible beams 146. The beams 146 can be arranged 180 degrees apart from one another and sized and shaped to slide within a corresponding opening 144. A locking flange 147 can be positioned on at least one flexible beam 146 so that when the introducer tube 115 is extended to its distal-most position as shown in FIGs. 8C, 8D, and 8K, the locking flange 147 extends through the opening 144 to temporarily lock the introducer tube 115 in “needle mode”. To retract the introducer tube 115, a projection 143 on the opposite flexible beam 146 can be urged inward, which in turn moves the flange 147 out from engagement with the opening 144 as the inner beam 146 flexes inward thereby releasing the temporary lock provided by the flange 147 and the opening 144. Once released, the movable element 162 can slide rearward relative to the stationary element 160towards its proximal position using the projection 143 as a slider. The retractation of the moveable element 162 can be automated or mechanically assisted with a spring, motor, or other form of mechanical assistance. The actuation mechanism controlling the introducer tube 115 position can actively push forward the introducer tube 115 into “needle mode” and a spring biases the movable element 162 distally such that the instrument shifts to “tool mode” only once active force is removed. Similarly, the forceps activation can be such that active force is used to place the forceps into “open” state and the release of said force brings the forceps into a “closed” state.

[0075] FIGs. 10A-10C, 11A-11D, 12A-12C, 13A-13C, and 14 illustrate example methods of using the devices described herein to externalize the fixation arms 305 of the device 300 shown in FIG. 3. FIGs. 10A-10C illustrate a device 300 having fixation arms 305 being loaded into an injector cartridge 400 (see also FIGs. 15A-15D and 16A-16C). The injector cartridge 400 can have a similar construction to an intraocular lens cartridge. A proximal end region 405 of the injector cartridge 400 can be designed to open and be sized to receive the device 300 (shown pre-loaded with an IOL 200 in FIG. 10A). FIG. 10B illustrates the device 300 folded within the proximal end region 405 of the injector cartridge 400 after closure of the proximal end region 405. The folded device 300 is positioned within the proximal end region 405 of the injector cartridge 400 adjacent an opening into a lumen 410 through an injector tip 415 of the injector cartridge 400. FIG. 10C illustrates the device 300 being urged distally through the lumen 410 using a loading tool 500 so that a leading fixation arm 305a is directed toward a distal opening 420 of the lumen 410 of the injector tip 415. The injector tip 415 has an angled distal opening 420 and a distal projection 430 extending distally beyond the distal opening 420, which will be described in more detail below.

[0076] The injector cartridge 400 with the distal projection 430 is particularly suited where control of the device after deployment through the injector is desired to prevent the device from falling towards the back of the eye. It should be appreciated that any of a variety of implantable ocular devices can be injected into the eye using the injector cartridge 400 incorporating the distal projection 430 described herein, including intraocular lenses (IOL) and support devices for IOLS. For example, the injector cartridge 400 with the distal projection 430 benefits the Yamane Technique of fixing IOL haptics, which can be performed using the microsurgical tools described herein. Description of the injector cartridge 400 incorporating the distal projection 430 being used to insert the IOL support device 300 and / or description ofthe microsurgical tools to grasp and externalize fixation arms of the IOL support device 300 is for purposes of example and is not intended to limit the use of the injector cartridge 400 or microsurgical tools to only that procedure. The injector cartridge 400 and microsurgical devices described herein can be used to deploy, manipulate, fixate other intraocular devices besides those described herein and be used to perform other surgical procedures including suturing, cutting, manipulating, and fixing.

[0077] FIGs. 11A-1 IE illustrate the device 300 being injected into the eye via the injector tip 415 and an introducer tube 115 of a microsurgical device 100. The microsurgical device 100 can be any of the interrelated microsurgical devices 100 described herein, including the ones illustrated in FIGs. 4A-4B, 5A-5B, 6A-6B, 7A-7B, 8A-8I, 8J-8K, and 9. FIG. 11A shows the distal projection 430 of the injector tip 415 inserted through an incision in the cornea 22 (or sclera 10) and inserted within the eye. The distal opening 420 of the injector tip 415 is preferably positioned so that it faces anteriorly and the distal projection 430 is posterior to the distal opening 420. FIG. 11A also shows the distal opening 118 of the introducer tube 115 of the microsurgical device 100 inserted through the sclera 10 at a sclerotomy located generally directly across from the location of where the injector tip 415 is inserted. The beveled end 117 of the introducer tube 115 is preferably facing anteriorly. The device 100 can be actuated and placed in “needle mode” with the introducer tube 115 locked in its distal-most position for insertion at a first penetration site. The device 100 can then be actuated with a first actuator 106 to “tool mode” by unlocking and retracting the introducer tube 115 proximally until it locks in its proximal-most position. The interventional tool assembly 120 is then free to be actuated using a second actuator 108 to grasp the first fixation arm 305 and externalize it as described elsewhere herein. FIG. 1 IB shows the introducer tube 115 retracted and the gripping tips 128 of the interventional tool 125 open and ready to grasp the leading fixation arm 305a of the device 300. The leading fixation arm 305a is projecting at least partially outside the distal opening 420 of the lumen 410 of the injector tip 415 so that the anchor 325a of the arm 305a is able to be grasped while the chassis 310 of the device 300 remains folded at least partially within the lumen 410 of the injector tip 415. The interventional tool 125 is shown about to grasp the anchor 325a as the device 300 is injected from the lumen 410 of the injector tip 415. It should be appreciated that the interventional tool 125 need not grasp the device 300 to maintain control of the device 300 upon injection. The distal projection 430 positioned posterior to the device 300 as it exits the lumen 410 is designed and positioned relative to the distal opening 420 from the lumen 410 of the injector tip 415 to maintain continuity of controlof the device 300 during and following injection of the device 300 into the eye. FIG. 11C shows the interventional tool 125 retracting to pull the leading fixation arm 305a towards the first sclerotomy as the chassis 310 of the device 300 further exits the distal opening 420 of the injector tip 415. FIGs. 1 ID-1 IE show the injector tip 415 removed from the incision and the interventional tool 125 pulling the anchor 325a of the device 300 through the sclerotomy so that the central opening 315 of the device 300 is positioned more centrally and is visible through the pupil 20.

[0078] The device 100 can be actuated back into “needle mode” by unlocking and advancing the introducer tube 115 distally until it locks in its distal-most position. The device 100 can be inserted at another penetration and used again as described above (see FIGs. 12A-12C and 13A-13D). FIG. 12A also shows the distal opening 118 of the introducer tube 115 inserted through the sclera at a second sclerotomy located generally about 120 degrees from the location of the first sclerotomy of FIGs. 11A-1 IE). FIG. 12B shows the introducer tube 115 retracting away from the gripping tips 128 of the interventional tool 125 so they can be used to grasp the anchor 325b of the trailing fixation arm 305b of the device 300. FIG. 12C shows the gripping tips 128 of the interventional tool 125 grasping the anchor 325b of the device 300 so it can be pulled through the second sclerotomy (shown in FIG. 14). FIG. 12A shows the device 100 inserted through a third sclerotomy located generally about 120 degrees from the location of the first sclerotomy and about 120 degrees from the location of the second sclerotomy. The distal beveled end 117 of the introducer tube 115 is retracted away from the gripping tips 128 of the interventional tool 125, which are splayed and ready to grab the anchor 325c of the other trailing fixation arm 305c of the device 300. FIG. 13B shows the interventional tool 125 being retracted to externalize the anchor 325c of the trailing fixation arm 305c through the third sclerotomy (see FIGs. 13C and 14).

[0079] Toggling the device 100 between “needle mode” and “tool mode” can be performed inside the eye with a single hand so that upon penetration the device 100 can transition seamlessly into the next stage of a procedure without needing to be removed. Alternatively, toggling the device 100 between “needle mode” and “tool mode” can performed outside the eye. For example, the device 100 in “needle mode” can be fully withdrawn from the eye after penetration, toggled into “tool mode” and then inserted through the same penetration. The anchors 325 can be grasped and released by the tips 128 (e.g., gripping tips 128 including a loop snare tip or forceps tips) of the device 100 as described elsewhere hereinin order to fix the anchors 325 trans-sclerally. Upon externalization of the anchor 325, the tips 128 can be at least partially reopened to release the anchor 325. The tips 128 are designed to atraumatically grip the anchor 325 and / or fixation arm 305 so as not to damage the device 300. The tips 128 of the interventional tool assembly 125 can provide tight grip with an atraumatic interaction with the fixation arm 305 or anchor 325 during the externalization process.

[0080] FIGs. 15A-15E illustrate an implementation of the injector cartridge 400 in an open configuration ready for loading a device 300. The proximal end region 405 of the injector cartridge 400 can be designed to articulate between an open configuration to receive the device 300 and a closed configuration for injection of the device through the lumen 410 into the eye. The device 300 can be prepared in a variety of manners including by folding or rolling for insertion through the injector tip 415. The device 300 can be pre-loaded with the IOL for injecting through the injector cartridge 400 as shown in FIG. 10A or the device 300 can be injected through the injector cartridge 400 without being loaded with a lens. Where an empty device 300 without any optical component is injected into an eye, the IOL can be injected into the device 300 using the same injector cartridge 400 or another injector cartridge 400 having the same configuration or a different configuration from what is shown in FIGs. 15A-15E, including any of a variety of conventional IOL injector tips. The injector cartridge 400 can be designed to mate with a handpiece having a loading tool or pushrod 500. The handpiece can be similar to the handpieces shown in FIG. 1 and others described herein having a proximal portion designed to stay outside the eye for a user to grip and a distal end portion that attaches to the injector cartridge 400. The proximal portion can incorporate one or more actuators designed to move the pushrod 500 relative to the injector cartridge 500. The pushrod 500 can extend at least partially through the lumen 410 of the injector cartridge 400 to deploy the device 300 into the eye. The pushrod 500 can have any of the following configurations including solid metal, solid plastic, or combination of metal or plastic with an elastomeric tip to cushion the contact surface.

[0081] The proximal end region 405 of the injector cartridge 400 can have a holding area 407 with any of a variety of sizes and shapes depending on the device 300 to be held within it. The holding area 407 of the proximal end region 405 can be shaped to correspond to the shape of the device 300 in a manner that provides guidance as to the loading of the device 300 relative to the cartridge 400. For example, the holding area 407 of the proximal end region 405 can be shaped to receive a lower surface of the device 300 so that theshape of the holding area 407 corresponds to the shape of the lower surface of the device 300. In some implementations, the trailing end of the device 300 is slightly narrower than the leading end of the device 300 and / or has a different arrangement of fixation arms 325 that are represented in the shape of the holding area 407 of the proximal end region 405 of the injector cartridge 400 to provide user guidance for receiving the device 300 in the proper orientation.

[0082] The holding area 407 of the proximal end region 405 is located just proximal of a proximal opening 408 into the lumen 410 so that the device 300 can be urged distally into the lumen 410, such as with the loading tool or push-rod 500. Generally, the lumen 410 is larger in inner diameter near the proximal opening 408 into the lumen 410 and smaller in inner diameter near the distal opening 420 from the lumen 410. The change in lumen size along the longitudinal axis of the lumen 410 further reduces the profile of the device 300 as it passes into the eye and ensures the leading arm 325a of the device 300 exits the distal opening 420 first.

[0083] The cross-sectional shape of the lumen 410 can vary including a circular, oval, or other geometrical shape. Generally, the shape of the lumen 410 as well as the holding area 407 of the proximal end region 405 of the injector cartridge 400 and any portion that is intended to come into contact with the device 300 has smooth or curved edges that avoid catching on the device 300 and / or causing damage.

[0084] The distal end region 403 of the injector tip 415 is sized to penetrate through an incision in the cornea for injection of the device 300 in a folded or rolled configuration. The distal end region 403 can have a short axis and a long axis or both axes can be similar in dimensions. The short axis of the distal end region 403 can be about 1.0 mm to 3.0 mm and the long axis can be about 1.0 mm to about 3.8 mm.

[0085] Typically, injector tips are designed with a distal opening that is elongate due to the beveled cut of the tube. The injector tip is cut at an angle relative to the longitudinal axis of the lumen so that the distal opening extends between a heel of the bevel and a distal- most tip of the injector tip. The injector tip 415 of FIGs. 15A-15E also has a distal opening 420 that is elongate and arranged at an angle relative to the longitudinal axis A of the lumen 410. The distal opening 420 extends between a heel 427 of the bevel and a proximal end region of the distal projection 430 (i.e., a distal end 428 of the distal opening 420). But the distal end 428 of the distal opening 420 is not the distal-most tip of the injector tip 415 becausethe distal projection 430 projects beyond the distal end 428 of the distal opening 410 (see FIG. 15C). Thus, the distal projection 430 extends distal to the bevel forming the distal opening 410. The distal projection 430 allows for the user to maintain continuity of control of the device 300 following injection from the injector tip 415 and without the use of an additional tool. This allows for the injector tip 415 to be used as a means of controlling the device 300 once it is injected inside the eye. For example, a user may have one hand manipulating the gripping tips 128 and a second hand manipulating the injector tip 415. The user can continue control of the device 300 (e.g., the chassis 310) with the second hand manipulating the injector tip 415 without risk of the device 300 falling into the posterior chamber, which could otherwise occur even while an anchor 325 of the device 300 may be held by the gripping tips 128 or worse, if the anchor 325 was inadvertently released by the gripping tips 128.

[0086] The distal projection 430 can have a width W substantially the same as a width of the distal opening or can be narrower than the width of the distal opening 420 (see FIG. 15E). The distal projection 430 could be wider than the width of the distal opening 420 although this is less preferred as it may impact the ability of the injector tip 415 to insert through the corneal incision. The width of the distal projection 430 is preferably no wider than a maximum diameter across the distal end of the injector tip 415. In some implementations, the distal projection 430 is about 0.25 mm to about 3.0 mm wide. The distal projection 430 can have a length L that enables it to project at least partially within the eye beyond the distal opening 420 for supporting the device 300 at least in part upon injection from the distal opening 420, but is not so long as to prevent the distal opening 420 itself from also entering the eye during use. The length L of the distal projection 430 from the distal end 428 of the distal opening 420 to a distal-most terminus of the injector tip 415 can be about 0.25 mm to about 10 mm. In some implementations, the distal projection 430 is about 0.25 mm wide by 3 mm long.

[0087] The distal projection 430 can have a thickness between its upper surface and its lower surface that is about a thickness of the wall of the injector tip lumen 410. The thickness of the distal projection can be about 0.05 mm to about 0.5 mm. The distal end of the distal projection 430 can have an atraumatic shape that is rounded as shown in FIG. 15E or an atraumatic shape that is angled (e.g., square, triangular, polygonal). The distal projection 430 can be generally flat from side to side or can curve slightly, for example, similar to the curvature of the wall of the lumen 410 (see FIG. 15B). The thickness, distal end shape, and curvature of the distal projection 430 additionally aids the surgeon in accessing the cornealincision as the injector tip 415 is urged through it. The injector tip can be formed of polypropylene, PEBAX, polycarbonate, or other suitable plastic material.

[0088] FIGs. 16A-16C illustrate the distal projection 430 relative to a device 300 that has been ejected from the distal opening 420 of the injector tip 415. FIG. 16A shows the device 300 in its solid form with the leading fixation arm anchor 325a externalized through the sclera 10, only the distal-most end of the distal projection 430 peeking through the central aperture 315 of the device 300, and the distal opening 420 of the injection tip 415 positioned proximal of the trailing end of the device 300. FIG. 16B shows the device 300 as transparent to illustrate the positioning of the distal projection 430 under the trailing end of the device 300 between the trailing fixation arms 305b, 305c. FIG. 16C shows the device 300 from the viewpoint of the posterior chamber of the eye up through the iris 25. The leading fixation arm anchor 325a is extending through the sclera 10 and the leading end of the device 300 under the iris. The trailing end of the device 300 is positioned on the upper surface of the distal projection 430 distal of the distal opening 420. The distal projection 430 can insert at least partially across the iris 25 over the pupil 20 to aid in positioning the device 300 posterior to the iris 25.

[0089] The devices described herein can also be used to externalize haptics of an intraocular device as shown in FIGs. 2A-2B for sutureless scleral fixation of an IGF comparable to the Yamane Technique. The Yamane Technique is a surgical technique that involves fixation of a three-piece IGF through two subconjunctival sclerotomies. The IGF can be inserted into the eye using the injector cartridge 400 having the distal tip 430 as described above for the device 300. A cartridge of this design is advantageous for such a procedure because the distal tip 430 can support the IGF from the posterior surface to prevent the IGF from falling into the vitreous cavity. A microsurgical device 100, including the ones illustrated in FIGs. 4A-4B, 5A-5B, 6A-6B, 7A-7B, 8A-8I, 8J-8K, and 9, can be used to fix the haptics of the IGF. For example, the device 100 can be actuated and placed in “needle mode” with the introducer tube 115 locked in its distal-most position for insertion at a first penetration site. The distal opening 118 of the introducer tube 115 of the microsurgical device 100 can be inserted through the sclera at a sclerotomy located at the desired haptic fixation location. The device 100 can then be actuated to “tool mode” by unlocking and retracting the introducer tube 115 proximally. The interventional tool assembly 120 can be actuated to grasp the first haptic for externalization at the site of the sclerotomy. The device can be placed back into “needlemode” in order to form the second sclerotomy at the desired fixation site of the second IOL haptic, generally 180 degrees from the first sclerotomy. After making the second sclerotomy and entering the eye, the device can be actuated to “tool mode.” The second haptic of the IOL can be grasped by the interventional tool assembly 120 and externalized. The first and second haptics can be fixed within the eye sequentially or simultaneously using two microsurgical tools. The ends of the haptics can then be cauterized to anchor the tip of the haptics outside the eye preventing the haptic from withdrawing back through the scleral tunnels into the posterior chamber. The flanged haptics can be manipulated beneath the conjunctiva and Tenon’s capsule where they sit on the scleral surface, within the sclerotomy, or embedded in a scleral flap.

[0090] In various implementations, description is made with reference to the figures. However, certain implementations may be practiced without one or more of these specific details, or in combination with other known methods and configurations. In the description, numerous specific details are set forth, such as specific configurations, dimensions, and processes, in order to provide a thorough understanding of the implementations. In other instances, well-known processes and manufacturing techniques have not been described in particular detail in order to not unnecessarily obscure the description. Reference throughout this specification to “one embodiment,” “an embodiment,” “one implementation, “an implementation,” or the like, means that a particular feature, structure, configuration, or characteristic described is included in at least one embodiment or implementation. Thus, the appearance of the phrase “one embodiment,” “an embodiment,” “one implementation, “an implementation,” or the like, in various placed throughout this specification are not necessarily referring to the same embodiment or implementation. Furthermore, the particular features, structures, configurations, or characteristics may be combined in any suitable manner in one or more implementations.

[0091] The devices and systems described herein can incorporate any of a variety of features. Elements or features of one implementation of a device and system described herein can be incorporated alternatively or in combination with elements or features of another implementation of a device and system described herein. For the sake of brevity, explicit descriptions of each of those combinations may be omitted although the various combinations are to be considered herein. Additionally, the devices and systems described herein can be positioned in the eye and need not be implanted specifically as shown in the figures or as 1described herein. The various devices can be implanted, positioned and adjusted etc. according to a variety of different methods and using a variety of different devices and systems. The various devices can be adjusted before, during as well as any time after implantation. Provided are some representative descriptions of how the various devices may be implanted and positioned, however, for the sake of brevity explicit descriptions of each method with respect to each implant or system may be omitted.

[0092] The use of relative terms throughout the description may denote a relative position or direction or orientation and is not intended to be limiting. For example, “distal” may indicate a first direction away from a reference point. Similarly, “proximal” may indicate a location in a second direction opposite to the first direction. Use of the terms “upper,” “lower,” “top”, “bottom,” “front,” “side,” and “back” as well as “anterior,” “posterior,” “caudal,” “cephalad” and the like or used to establish relative frames of reference, and are not intended to limit the use or orientation of any of the devices described herein in the various implementations .

[0093] While this specification contains many specifics, these should not be construed as limitations on the scope of what is claimed or of what may be claimed, but rather as descriptions of features specific to particular embodiments. Certain features that are described in this specification in the context of separate embodiments can also be implemented in combination in a single embodiment. Conversely, various features that are described in the context of a single embodiment can also be implemented in multiple embodiments separately or in any suitable sub-combination. Moreover, although features may be described above as acting in certain combinations and even initially claimed as such, one or more features from a claimed combination can in some cases be excised from the combination, and the claimed combination may be directed to a sub-combination or a variation of a sub-combination. Similarly, while operations are depicted in the drawings in a particular order, this should not be understood as requiring that such operations be performed in the particular order shown or in sequential order, or that all illustrated operations be performed, to achieve desirable results. Only a few examples and implementations are disclosed. Variations, modifications and enhancements to the described examples and implementations and other implementations may be made based on what is disclosed.

[0094] In the descriptions above and in the claims, phrases such as “at least one of’ or “one or more of’ may occur followed by a conjunctive list of elements or features. Theterm “and / or” may also occur in a list of two or more elements or features. Unless otherwise implicitly or explicitly contradicted by the context in which it is used, such a phrase is intended to mean any of the listed elements or features individually or any of the recited elements or features in combination with any of the other recited elements or features. For example, the phrases “at least one of A and B;” “one or more of A and B;” and “A and / or B” are each intended to mean “A alone, B alone, or A and B together.” A similar interpretation is also intended for lists including three or more items. For example, the phrases “at least one of A, B, and C;” “one or more of A, B, and C;” and “A, B, and / or C” are each intended to mean “A alone, B alone, C alone, A and B together, A and C together, B and C together, or A and B and C together.”

[0095] Use of the term “based on,” above and in the claims is intended to mean, “based at least in part on,” such that an unrecited feature or element is also permissible.

Claims

CLAIMSWhat is claimed is:

1. A microsurgical device for ocular surgery, the microsurgical device comprising: a proximal portion comprising a housing for manipulation of the microsurgical device; and a distal portion coupled to and extending distally from the housing, at least a distal end region of the distal portion being sized and shaped for insertion into an eye, the distal portion comprising: an introducer tube comprising an introducer lumen and a distal beveled end defining a distal opening from the introducer lumen, the distal beveled end configured for creating a penetration of the eye; and an interventional tool assembly sized to be received within the introducer lumen, wherein the introducer tube is movable relative to the interventional tool assembly, the interventional tool assembly comprising: an outer collar comprising a blunt distal edge defining a distal opening into the outer collar; and an interventional tool extending through the outer collar, the interventional tool comprising a distal end, wherein the outer collar and / or the interventional tool are movable relative to one another to actuate the interventional tool.

2. The microsurgical device of claim 1, wherein the penetration of the eye is through a cornea or a sclera and / or a conjunctiva.

3. The microsurgical device of claim 1 or claim 2, wherein the penetration is selfsealing.

4. The microsurgical device of claim 3, wherein the penetration has an incision length that is 0.25 mm to 1.5 mm.

5. The microsurgical device of any one of claims 1 - 4, wherein the introducer tube is 23 gauge, 24 gauge, 25 gauge, 26 gauge, 27 gauge, 28 gauge, 29 gauge, or 30 gauge needle.

6. The microsurgical device of any one of claims 1 - 5, wherein the introducer tube is a regular wall, thin wall, extra-thin wall, or ultra-thin wall needle.

7. The microsurgical device of any one of claims 1 - 6, wherein the distal beveled end comprises a tip and a heel.

8. The microsurgical device of claim 7, wherein a length from the tip to the heel of the distal beveled end is 0.5 mm to 10 mm.

9. The microsurgical device of claim 7 or claim 8, wherein the tip is sharp.

10. The microsurgical device of any one of claims 1 - 9, wherein the housing comprises a first actuator designed to axially move the introducer tube relative to the interventional tool assembly.

11. The microsurgical device of claim 10, wherein the housing comprises a second actuator designed to axially move the outer collar relative to the interventional tool.

12. The microsurgical device of claim 10 or claim 11, wherein the first actuator is movable between a first position and a second position.

13. The microsurgical device of claim 12, wherein, when the first actuator is in the first position, the introducer tube is advanced to a distal-most position relative to the interventional tool assembly.

14. The microsurgical device of claim 13, wherein the distal-most position of the introducer tube comprises the distal beveled end being located distal to the distal end of the interventional tool.

15. The microsurgical device of claim 13 or claim 14, wherein the introducer tube is temporarily locked in the distal-most position upon the first actuator being placed in the first position.

16. The microsurgical device of any one of claims 12 - 15, wherein, when the first actuator is in the second position, the introducer tube is retracted to a proximal-most position relative to the interventional tool assembly.

17. The microsurgical device of claim 16, wherein the proximal-most position of the introducer tube comprises the distal beveled end being located proximal to the distal end of the interventional tool.

18. The microsurgical device of claim 16, wherein the introducer tube is temporarily locked in the proximal-most position upon the first actuator being placed in the second position.

19. The microsurgical device of claim 16, wherein the introducer tube is temporarily locked in a plurality of locking positions along a length of the microsurgical device.

20. The microsurgical device of claim 16, wherein the introducer tube is rotatable about a longitudinal axis of the introducer tube.

21. The microsurgical device of any one of claims 1 - 20, wherein the interventional tool assembly is designed to be fully internalized within the introducer lumen in the first position.

22. The microsurgical device of claim 1, wherein the interventional tool assembly is no greater than about 23 gauge.

23. The microsurgical device of any one of claims 1 - 22, wherein the interventional tool assembly comprises an interventional tool that is designed to cut or to grasp, or both.

24. The microsurgical device of claim 23, wherein the interventional tool is designed to cut comprises a scalpel or scissors.

25. The microsurgical device of claim 23, wherein the interventional tool is designed to grasp comprises a snare or forceps.

26. The microsurgical device of any one of claims 1 - 25, wherein the interventional tool assembly is removable from the distal portion for replacement by a second interventional tool assembly.

27. The microsurgical device of any one of claims 1 - 26, wherein the interventional tool comprises forceps having two elongated arms terminating in gripping tips, each gripping tip integral with a respective elongated arm.

28. The microsurgical device of claim 27, wherein the distal opening of the outer collar is sized to encircle, at least in part, the two elongated arms.

29. The microsurgical device of claim 28, wherein the gripping tips are urged towards one another upon extension of the outer collar relative to the two elongate arms.

30. The microsurgical device of claim 28, wherein the gripping tips splay away from one another upon retraction of the outer collar relative to the two elongate arms.

31. The microsurgical device of claim 27, wherein the gripping tips are flat, smooth, serrated, end-grasping or arced into a hemispherical shape.

32. The microsurgical device of claim 27, wherein the elongate arms are biased away from one another.

33. The microsurgical device of any one of claims 1 - 32, wherein the interventional tool comprises scissors and comprises two cutting edges.

34. The microsurgical device of claim 33, wherein the two cutting edges are urged towards one another upon extension of the outer collar relative to the scissors.

35. The microsurgical device of claim 34, wherein the two cutting edges move away from one another upon retraction of the outer collar relative to the scissors.

36. A system comprising the microsurgical device of any one of claims 1 - 35 and an injector cartridge.

37. The system of claim 36, further comprising an implantable device, wherein the implantable device comprises an intraocular lens or a device for supporting the intraocular lens within an eye having impaired or defective native capsular bag support for the intraocular lens.

38. A method of using a microsurgical device of any one of claims 1-37 to perform suturing inside the eye and / or to the sclera.

39. A method of using a microsurgical device of any one of claims 1-37 to perform trans-scleral fixation of an implantable device, wherein the implantable device comprises an intraocular lens or a device for supporting the intraocular lens.

40. An injector cartridge for injecting an implantable device into an eye, the injector cartridge comprising: a proximal end region comprising a holding area sized and shaped to receive the implantable device; a distal end region comprising an injector tip having a lumen extending between a proximal opening and a distal opening, wherein the holding area of the proximal end region is located just proximal to the proximal opening into the lumen; and a distal projection extending distally beyond the distal opening of the distal end region.

41. The injector cartridge of claim 40, wherein the distal end region is sized to penetrate a cornea for injection of the implantable device into the eye.

42. The injector cartridge of claim 40 or 41, wherein the distal projection maintains continuity of control of the implantable device upon injection of the implantable device out the distal opening of the injector tip.

43. The injector cartridge of any one of claims 40-42, wherein the distal opening extends between a heel of a bevel of the injector tip and a proximal end region of the distal projection.

44. The injector cartridge of any one of claims 40-43, wherein the distal projection forms a distal-most terminus of the injector cartridge.

45. The injector cartridge of claim 44, wherein the distal projection has a length along a longitudinal axis of the lumen that is from a distal end of the distal opening to the distal-most terminus of the injector cartridge.

46. The injector cartridge of claim 45, wherein the length is about 1 mm to about 10 mm.

47. The injector cartridge of claim 45 or claim 46, wherein the distal projection has a width across the length.

48. The injector cartridge of claim 47, wherein the width is about 0.25 mm to about 3 mm.

49. The injector cartridge of claim 47 or 48, wherein the width of the distal projection is substantially equal to or narrower than a width of the distal opening.

50. The injector cartridge of any one of claims 45-49, wherein the distal projection has a thickness between an upper surface and a lower surface of the distal projection.

51. The injector cartridge of claim 50, wherein the thickness is substantially equal to a wall thickness of the lumen of the injector tip.

52. The injector cartridge of claim 50 or 51, wherein the thickness is about 0.05 mm to about 0.5 mm.

53. The injector cartridge of any one of claims 44-52, wherein the distal-most terminus has an atraumatic shape.

54. The injector cartridge of claim 53, wherein the atraumatic shape is round or angled.

55. The injector cartridge of any one of claims 40-54, wherein the distal projection is flat from side to side or curves.

56. The injector cartridge of any one of claims 40-55, wherein a curvature of the distal projection is substantially similar to a curvature of a wall of the lumen.

57. The injector cartridge of any one of claims 40-56, wherein the holding area of the proximal end region is designed to articulate between an open configuration and a closed configuration.

58. The injector cartridge of any one of claims 40-57, wherein an inner diameter of the lumen near the proximal opening is larger than an inner diameter of the lumen near the distal opening.

59. The injector cartridge of any one of claims 40-58, wherein the injector cartridge is configured to mate with a handpiece.

60. The injector cartridge of claim 59, wherein the handpiece further comprises a pushrod configured to extend at least partially through the lumen of the injector cartridge to deploy the implantable device into the eye.

61. The injector cartridge of any one of claims 40-60, wherein the implantable device is an intraocular lens, or a device designed to support an intraocular lens.

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