WO2017087713A1

WO2017087713A1 - Delivery device systems and implants for treating glaucoma

Info

Publication number: WO2017087713A1
Application number: PCT/US2016/062598
Authority: WO
Inventors: Todd N. Fjield; Charles Raymond KALINA; Douglas Daniel CRIMALDI
Original assignee: Glaukos Corporation
Priority date: 2015-11-19
Filing date: 2016-11-17
Publication date: 2017-05-26
Also published as: KR20170058811A

Abstract

An ocular implant (100) has a distal cutting tip for piercing through a trabecular meshwork to allow a distal portion of the stent to be positioned within Schlemm's canal. A snorkel portion of the implant remains in the anterior chamber and conducts aqueous humor from the anterior chamber into Schlemm's canal. A delivery device has tines (424) that splay to release the implant when the tines are unsheathed from an outer sheath (426) of the delivery device.

Description

DELIVERY DEVICE SYSTEMS AND IMPLANTS FOR TREATING GLAUCOMA

BACKGROUND

Field

[0001] The invention relates generally to systems, devices and methods for delivering implants to facilitate, permit or increase aqueous outflow out of an anterior chamber of an eye to promote or control reduction of intraocular pressure and therefore to facilitate treatment of ocular diseases such as glaucoma.

Description of the Related Art

[0002] The mammalian eye is a specialized sensory organ capable of light reception and able to receive visual images. The trabecular meshwork serves as a drainage channel and is located in anterior chamber angle formed between the iris and the cornea. The trabecular meshwork maintains a balanced pressure in the anterior chamber of the eye by draining aqueous humor from the anterior chamber.

[0003] Glaucoma is a group of eye diseases encompassing a broad spectrum of clinical presentations, etiologies, and treatment modalities. Glaucoma causes pathological changes in the optic nerve, visible on the optic disk, and it causes corresponding visual field loss, resulting in blindness if untreated. Lowering intraocular pressure is the major treatment goal in all glaucomas.

[0004] In glaucomas associated with an elevation in eye pressure (intraocular hypertension), the source of resistance to outflow is mainly in the trabecular meshwork. The tissue of the trabecular meshwork allows the aqueous humor ("aqueous") to enter Schlemm's canal, which then empties into aqueous collector channels in the posterior wall of Schlemm's canal and then into aqueous veins, which form the episcleral venous system. Aqueous humor is a transparent liquid that fills the region between the cornea, at the front of the eye, and the lens. The aqueous humor is continuously secreted by the ciliary body around the lens, so there is a constant flow of aqueous humor from the ciliary body to the eye's front chamber. The eye's pressure is determined by a balance between the production of aqueous and its exit through the trabecular meshwork, uveoscleral outflow pathways (such as the supraciliary space, suprachoroidal space), or other physiological outflow pathways or drainage routes (such as the episcleral veins). The trabecular meshwork is located between the outer run of the iris and the back of the cornea, in the anterior chamber angle. The portion of the trabecular meshwork adjacent to Schlemm's canal (the juxtacanalicular meshwork) causes most of the resistance to aqueous outflow.

[0005] Current medical therapy includes topical ophthalmic drops or oral medications that reduce the production or increase the outflow of aqueous. However, these drug therapies for glaucoma are sometimes associated with significant side effects, such as headache, blurred vision, allergic reactions, death from cardiopulmonary complications, and potential interactions with other drugs. When drug therapy fails, surgical therapy is used. Surgical therapy for open-angle glaucoma consists of laser trabeculoplasty, trabeculectomy, and implantation of aqueous shunts after failure of trabeculectomy or if trabeculectomy is unlikely to succeed. Trabeculectomy is a major surgery that is widely used and is augmented with topically applied anticancer drugs, such as 5-flurouracil or mitomycin-C to decrease scarring and increase the likelihood of surgical success.

[0006] All of the above surgeries and variations thereof have numerous disadvantages and moderate success rates. They involve substantial trauma to the eye and require great surgical skill in creating a hole through the full thickness of the sclera into the subconjunctival space. The procedures are generally performed in an operating room and have a prolonged recovery time for vision.

SUMMARY

[0007] Systems, devices and methods for treating ocular disorders (such as glaucoma) are disclosed herein. Some aspects provide a self-trephining glaucoma shunt and deliver}' devices that advantageously allow for a "one-step" procedure in which the incision and placement of the shunt are accomplished by a single device and operation. This desirably allows for a faster, safer, and less expensive surgical procedure. Techniques performed in accordance with certain aspects herein involving deliver}' of implants through the trabecular meshwork and into Schlemm's canal, uveoscleral outflow pathways (such as a supraciliary space and/or suprachoroidal space) or other drainage outflow routes may be referred to generally as "trabecular bypass surgery." Advantages of this type of surgery include lowering intraocular pressure in a manner which is simple, effective, disease site-specific, and can potentially be performed on an outpatient basis. The method comprises bypassing diseased trabecular meshwork with the use of an implant (such as a shunt). The shunt is used to prevent a healing process known as filling in, which has a tendency to close surgically created openings in the trabecular meshwork. In accordance with several embodiments, in addition to bypassing the diseased trabecular meshwork at the level of the trabecular meshwork, existing outflow pathways are also used or restored. In one embodiment, the shunt is positioned through the trabecular meshwork so that an inlet end of the shunt is exposed to the anterior chamber of the eye and an outlet end is positioned into fluid collection channels at about an exterior surface of the trabecular meshwork or up to the level of aqueous veins.

[0008] In some preferred embodiments, the shunt has an inlet portion configured to extend through a portion of the trabecular meshwork of an eye, and an outlet portion configured to extend into Schlemm's canal of the eye, wherein the inlet portion is disposed at an angle relative to the outlet portion. In other embodiments, the outlet portion of the shunt is sized and configured to extend directly into collector channels branching off from Schlemm's canal, into a supraciiiary space, into a suprachoroidal space, into a subconjunctival space, into episcleral or aqueous veins, or other outflow routes or drainage locations.

[0009] Various embodiments disclosed herein can relate to an ocular implant delivery system for implanting an implant into a human eye. The delivery system can include an implant having a proximal portion and a distal portion. The proximal portion of the implant can include a snorkel sized to be received within an anterior chamber of the eye. The distal portion of the implant can extend at an angle from the proximal portion of the implant and have a curved radially inward surface that partially surrounds a longitudinal axis of the distal portion. At least a portion of the distal portion of the implant can be sized and shaped to be received within Schlemm's canal.

[0010] The delivery system can include a delivery device that includes a handpiece and a delivery assembly. The handpiece can include an actuator, a distal end, a proximal end, and a main body interposed between the distal and proximal ends of the handpiece. The deliver}' assembly can be positioned partially within the main body of the handpiece and extend distally beyond the distal end of the handpiece. The delivery assembly can include an elongate member and an outer sheath. The elongate member can have a distal end portion that includes a grasper having a plurality of tines. Each tine can have a proximal portion and a distal portion, with the distal portion being biased to splay radially outward relative to the proximal portion of the tine in an unconstrained configuration. The distal portion of each tine can be bent at an angle with respect to the proximal portion. The outer sheath can circumferentially surround the elongate member and be longitudinally movable with respect to the elongate member. The outer sheath can have a distal-most portion that has a smaller outer dimension relative to a proximal portion of the outer sheath. The grasper can be configured to securely retain the snorkel of the implant until deployment. The actuator of the handpiece can be configured to move the outer sheath longitudinally with respect to the elongate member to effect unsheathing and resheathing of at least a portion of the grasper, thereby facilitating deployment and re-capture of the implant.

[0011] In some aspects, the implant includes a cutting tip disposed on a distal- most surface of the implant. The cutting tip can pierce a trabecular mesh work of the eye. The tines can have a retracted position and a deployed position, with the tines extending distally further out of the outer sheath in the deployed position than in the retracted position. The actuator can cause the tines to transition between the retracted and deployed positions by causing the outer sheath to move longitudinally toward a proximal end of the handpiece until at least the distal portion of each tine is advanced out of the outer sheath. The tines can secure the implant to the delivery device when the tines are in the retracted position. The tines can release the implant from the delivery device when the tines are in the deployed position. In some aspects, the delivery assembly includes a cam coupled to the actuator and to a proximal end of the outer sheath. The cam can have a bearing surface and a pivot. The cam can rotate about the pivot when the actuator is depressed, causing the outer sheath to retract in a longitudinally proximal direction. The elongate member can include a hypotube. The length of the distal portion of each tine compared to the overall length of the tine can be about 1 :4. The difference in distance between the distal most surface of the tines and the distal terminus of the outer sheath can be between about 0.030" and 0.060".

[0012] In some aspects, a wall thickness of the distal-most portion of the outer sheath can be less than a wall thickness of the proximal portion of the outer sheath. The proximal portion of the outer sheath can have a stiffness that is greater than a stiffness of the distal-most portion of the outer sheath. The plurality of tines can consist of only four tines. The actuator can be a push button.

BRIEF DESCRIPTION OF THE DRAWINGS

[0013] Various embodiments are depicted in the accompanying drawings for illustrative purposes, and should in no way be interpreted as limiting the scope of the embodiments. Furthermore, any features, structures, components, materials, and/or steps of different disclosed embodiments can be combined to form additional embodiments, which are part of this disclosure.

[ 0014] FIG. 1 is an isometric view of an embodiment of an implant.

[0015] FIG. 2 is an isometric view of an embodiment of an implant.

[0016] FIG. 2 A is a cross-sectional end view of the implant in FIG. 2.

[0017] FIG. 2B is a cross-sectional side view of the implant in FIG. 2.

[0018] FIG. 3 is a side view of an embodiment of a delivery device adapted to deliver the implant in FIGS 1 and 2.

[0019] FIG. 4 is a side view of an embodiment of a distal portion of the delivery device holding the implant in FIGS. 1 and 2.

[0020] FIG. 5A is a side view of the distal portion of FIG. 4 after the delivery device has released the implant.

[0021] FIG. 5B is an isometric view of a distal portion of an embodiment of an outer sheath of the delivery device.

[0022] FIG. 5C is an isometric view of a distal portion of an embodiment of an outer sheath of the delivery device.

[0023] FIG. 6 is a cross-sectional side view showing the internal components of the distal portion of an embodiment of the delivery device of FIGS. 4 and 5 A.

[0024] FIG. 7 A is a cross-sectional side view showing an embodiment of an actuator of the delivery device of FIGS. 4 and 5A before the actuator has caused the delivery device to release the implant.

[0025] FIG. 7B is a cross-sectional view of the actuator in FIG. 7A after the actuator has caused the delivery device to release the implant.

[0026] FIG. 8 is an illustration of an ah interno method of implanting the implant of FIGS. 1 and 2 into Schlemm's canal. [0027] FIG. 9 is an illustration of the implant of FIGS. 1 and 2 implanted in Schlemm's canal.

DETAILED DESCRIPTION

[0028] In the following detailed description, reference is made to the accompanying drawings, which form a part hereof. In the drawings, similar symbols typically identify similar components, unless context dictates otherwise. The illustrative embodiments described in the detailed description and drawings are not meant to be limiting. Other embodiments may be utilized, and other changes may be made, without departing from the spirit or scope of the subject matter presented here. The aspects of the present disclosure, as generally described herein, and illustrated in the figures, may be arranged, substituted, combined, and designed in a wide variety of different configurations, all of which are explicitly contemplated and made a part of this disclosure.

[0029] An ocular implant (for example, stent or shunt) adapted to shunt or divert aqueous humor in the eye from the anterior chamber into Schlemm's canal includes a distal portion sized and shaped to be inserted withm and along a portion of Schlemm's canal, and a proximal portion sized and shaped to be positioned within the anterior chamber of the eye upon implantation, wherein the ocular implant permits or facilitates fluid communication (for example, aqueous humor outflow) from the anterior chamber to Schlemm's canal through or along the ocular implant. In some embodiments, the outlet portion of the shunt is sized and configured so as to shunt fluid from the anterior chamber directly into collector channels branching off from Schlemm's canal, into a supraciliary space, into a suprachoroidal space, into a subconjunctival space, into episcleral or aqueous veins, or other outflow routes or drainage locations.

Ocular Implant

[0030] One embodiment of an ocular implant (for example, shunt or stent) is illustrated in FIG. 1, in which the implant 100 is shown in a side view. The implant 100 includes a proximal portion 200 and a distal portion 300. As shown in FIG. 1 , the proximal portion 200 can include a snorkel 210 that has a longitudinal axis 212. In some variants, the snorkel 210 can completely circumferential ly surround the longitudinal axis 212, thereby defining an enclosed tubular channel 214 that communicates between an inlet opening 216 at a proximal end of the snorkel 210 and an outlet opening 218 (shown in FIG. 2B) at an opposing distal end of the snorkel 210. However, the snorkel 210 need not completely circumferentially surround the longitudinal axis 212 (for example, partially tubular, half-pipe shaped or trough-like). In the illustrated embodiment, the snorkel 210 is straight and has a uniform diameter.

[0031] The distal portion 300 of the implant 100 can be substantially linear and have a longitudinal axis 312 that is substantially perpendicular to the longitudinal axis 212 of the proximal portion 200. As shown in FIG. 1 , the distal portion 300 can only partially circumferentially surround the longitudinal axis 312, having a concave surface 314 that faces the longitudinal axis 312 and defines an open-channeled groove extending along the length of the distal portion 300. In some variants, the distal portion 300 can have a slight curvature along its length that allows the distal portion 300 to more closely track or conform to the curvature of Schlemm's canal. The implant 100 can be oriented in either a "right-hand" or a "left-hand' configuration. For example, in FIG. 1, in a "left-hand" orientation the distal portion 300 of the implant extends to the left when the implant 100 is viewed facing the concave surface 314 with the snorkel 210 pointed upward. However, the implant 100 can be configured in a "right-hand' orientation in which the distal portion 300 extends to the right when the implant 100 is viewed facing the concave surface 314 with the snorkel 210 pointed upward.

[0032] The distal portion 300 can include a cutting tip 304 that is capable of piercing ocular tissue (e.g., the trabecular meshwork). The cutting tip 304 can be disposed on a distal-most surface of the implant 100. The distal portion 300 can include one or more retention arches 320 that protrude from a concave surface 316 of the distal portion 300. The retention arches 320 can completely, or only partially, circumferentially surround the concave surface 316. The retention arches 320 can be configured to atraumatically engage surrounding tissues. For example, the retention arches 320 can be configured to provide an increased area of contact with surrounding tissue. As shown in FIG. 1, a distal-facing surface 322 may form an angle with the concave surface 316 that is greater than the angle a proximal facing surface 324 forms with the concave surface 316, thereby providing an oblique surface that surrounding tissue can rest on when the implant 100 is implanted into Schlemm's canal In some variants, the distal-facing surface 322 forms an angle with the concave surface 316 of between about 100° to about 170°, For example, the distal-facing surface 322 can form an angle with the concave surface 316 of about: 130°, 140°, 150°, or 160°. In some embodiments, the proximal-facing surface 324 is substantially perpendicular to the radially outward surface 316. In some variants, the retention arches 320 can be configured to prevent or reduce movement of the implant 100 in the direction of the longitudinal axis 312 of the distal portion 300.

[0033] The implant 100 can be configured to be implanted into a human eye. For example, the implant 100 can be sized so that the inlet opening 216 resides in an anterior chamber of the eye when the distal portion 300 is inserted into Schiemm's canal. The snorkel 210 can have an outer diameter of between about 120 μπι and about 240 μτη. For example, the snorkel 210 can have an outer diameter of about: 150 μτη, 170 um, 180 μηι, or 200 μτη. The channel 214 can have a diameter of between about 80 μτη and aboutl 60 μτη. For example, the channel 214 can have a diameter of about: 100 urn, 110 μτη, 120 μτη, or 140 μηι The distance between the inlet opening 216 and the outlet opening 218 can be between about 100 um and about 400 μτη. For example, the distance between the inlet opening 216 and the outlet opening 218 can be about: 180 um, 210 μτη, 240 um, or 300 μηι. The length of the distal portion 300 from the snorkel 210 to the cutting tip 304 can be between about 0.5 mm to about 2 mm. For example, the length of the distal portion 300 from the snorkel 210 to the cutting tip 304 can be about: 0.7 mm, 0.9 mm, 1 mm, or 1.5 mm. The distance of the concave surface 316 from the longitudinal axis 312 can be between about 80 μτη and about 160 μτη. For example, the distance of the concave surface 316 from the longitudinal axis 312 can be about: 100 μτη, 110 um, 120 μηι, or 140 μτη. The retention arches 320 can extend beyond the concave surface 316 by about between about 20 μτη and about 80 μηι. For example, the retention arches 320 can extend beyond the concave surface 316 by about: 30 μηι , 40 μηι , 50 μηι, or 60 μτη.

[0034] The implant 100 is adapted to facilitate drainage of aqueous from the anterior chamber through the proximal portion 200 of the implant 100 to the distal portion 300 of the implant 100 in Schiemm's canal, thereby bypassing the trabecular meshwork through which the implant 100 is placed. For example, as shown in FIG. 1 , the outlet opening 218 of the snorkel 210 can be configured to provide fluid communication between the inlet opening 216 and the distal portion 300 of the implant 100. in some variants, aqueous can enter the channel 214 of the snorkel 210 at the inlet opening 216 of the implant 100 and then enter the distal portion 300 of the implant 100 by flowing out of the channel 214 at the outlet opening 218. In some embodiments, aqueous can flow along the distal portion 300 of the implant 100 toward the distal tip 304.

[0035] FIG, 2 is an isometric view of an embodiment of the implant 100 showing the orientation of the views in FIGS. 2A and 2B. A cross-sectional end view of the implant 100 is shown in FIG. 2A. As illustrated in FIG. 2A, a plane 318 can extend across the channel defined by the concave surface 314. The implant 100 can be arranged so that the longitudinal axis 212 of the snorkel 210 intersects the plane 318 at an acute angle (e.g., about 45°). In some variants, the implant 100 is arranged so that the longitudinal axis 212 is perpendicular or substantially perpendicular to the plane 318. As shown in FIG. 2B, the outlet opening 218 of the snorkel 210 can open onto the concave surface 314 of the distal portion 300.

[0036] The material for the implant 100 may be selected from the group consisting of porous material, semi-rigid material, soft material, hydrophilic material, hydrophobic material, hydrogel, elastic material, and the like. In some embodiments, the implant 100 is made of a biocompatible material (e.g., surgical-grade nonferromagnetic titanium). The implant 100 may comprise a biocompatible polymer, such as a medical grade silicone, for example, the material sold under the trademark Silastic®, which is available from Dow Coming Corporation of Midland, Michigan, or polyurethane, which is sold under the trademark Pellethane®, which is also available from Dow Corning Corporation. In an alternate embodiment, other biocompatible materials (biomaterials) may be used, such as polyvinyl alcohol, polyvinyl pyrolidone, collagen, heparinized collagen, tetrafluoroethylene, fluorinated polymer, fluorinated elastomer, flexible fused silica, polyolefin, polyester, polysilicon, mixture of biocompatible materials, and the like. In a further alternate embodiment, a composite biocompatible material formed by surface coating the above- mentioned biomaterial may be used, wherein the coating material may be selected from the group consisting of polytetrafluoroethylene (PTFE), polyimide, hydrogel, heparin, therapeutic drugs, and the like. For example, the implant 100 can be coated in heparin to prevent against thrombolytic activity and restenosis. Delivery Device

[0037] FIG. 3 depicts an embodiment of a deliver}' device 400 designed, or adapted, to deliver (e.g., insert or implant) the implant 100 of FIGS. 1 and 2 to a desired implantation location. The delivery device 400 may also be referred to as an applicator or an inserter. The delivery device 400 can include an ergonomic main body or handpiece 410 and an elongate delivery assembly 420 that extends distally beyond a distal end of the main body or handpiece 410. The handpiece 410 can include an actuator 450 positioned along the length of the main body or handpiece 410. In preferred embodiments, the actuator 450 is a button that can be at least partially depressed into the housing of the handpiece 410. As described below, the actuator 450 can be configured to cause the delivery device 400 to release the implant 100 from the delivery device 400 when the actuator 450 is depressed. In other variants, the actuator 450 is actuated by a sliding mechanism.

[0038] FIG. 4 shows a distal portion 422 of the delivery devi ce 400. The elongate delivery assembly 420 can include an outer sheath 426 and an elongate member 440 (such as a hypotube or rod) positioned coaxially within the outer sheath 426 (as best shown in FIG. 6), with the outer sheath being longitudinally moveable with respect to the elongate member, or vice-versa. A distal end portion of the elongate member 440 may include a grasper or collet comprised of one or more tines 424. The tines 424 can be adapted to grip at least a portion of the implant 100. For example, as illustrated in FIG. 4, the tines 424 can be configured to grip the proximal portion 200, or snorkel, of the implant 100. The tines 424 can be formed by cutting slits in a distal end portion of a hypotube or other elongate member with a femtosecond laser, other laser cutting device, or other machining methods (e.g., wire electrical discharge machining). For example, two perpendicular slits may be cut to form four individual tines. The elongate member may comprise stainless steel, nickel titanium alloys or any other metallic, metallic alloy, or polymeric material as desired and/or required. In some embodiments, the implant 100 is preloaded in the delivery device 400 and provided together with the delivery device 400 in a single sterile package. In other embodiments, the implant 100 is not preloaded on the delivery device 400.

[0039] The outer dimension 428 of the outer sheath 426 can vary across its length. In some embodiments, the outer sheath 426 can have a decreasing taper in the distal direction. As shown in FIG. 5A, the taper of the outer sheath 426 can be discontinuous. For example, the outer sheath 426 can include a distal-most region 430 and a proximal-most region 432 that both have a substantially constant outer dimension, with the outer dimension of the distal-most region 430 being smaller than the outer dimension of the proximal-most region 432. The outer sheath 426 can include a tapered intermediate region 431 that connects the distal-most region 430 to the proximal-most region 432. The outer dimension of the distal-most region 430 can be kept small so as to not obscure a clinician's view. The outer dimension of the proximal-most region 432 can be enlarged to increase the stiffness of the outer sheath 426, thereby improving tactile feedback to the physician or other clinical professional, in some embodiments, the taper can extend to the distal-most face of the outer sheath 426 of the delivery device 400, as shown in FIG. SB. In some variants, the outer sheath 426 can include one or more notches or flats 435. The notches or flats 435 can be configured to balance improving visibility with maintaining sheath stiffness. The notches or flats 435 can extend into all, some, or none of the tapered region and/or into all, some, or none of the regions that have a substantially constant outer dimension. For example, as illustrated in FIG. 5C, the outer sheath 426 can have a pair of notches or flats 435 spaced circumferential ly 180° apart from one another, with each notch or flat 435 extending through the entire tapered region 431" and into a portion of the proximal-most region 432". In some embodiments, the one or more notches or flats 435 extend through a portion of the tapered region 431". in some variants, only a single notch or flat is provided on one side of the outer sheath 426.

[0040] For the delivery device illustrated in FIG. 5A, the ratio between the outer dimension of the distal-most region 430 and the outer dimension of the proximal-most region 432 is about 0.7. In other variants, this ratio is at least about; 0.6, 0.75, 0.8, 0.9, values between the aforementioned values, and otherwise. In some embodiments, the outer dimension of the distal-most region 430 is between about 0.3 mm and about 0.6 mm. For example, the outer dimension of the distal-most region 430 can be about: 0.4 mm, 0.45 mm, 0.5 mm, or 0.55 mm. In some embodiments, the outer dimension of the proximal-most region 432 is between about 0.4 mm and about 0.8 mm. For example, the outer dimension of the proximal-most region 432 can be about: 0.5 mm, 0.6 mm, or 0.7 mm. In the delivery device illustrated in FIG. 5A, the tapered intermediate region 431 rises to meet the proximal-most region 430 at an angle of about 5°. In other variants, this angle is between about 2° and about 5°. For example, this angle can be at least about: 3°, 6°, 8°, or 10°.

[0041] The outer sheath 426 can be tapered by grinding down the distal-most region 430 of a straight cylindrical tube, thereby producing an outer sheath 426 that has a wall thickness in the distal-most region 430 that is less than the wall thickness in the proximal-most region 432. For example, the distal-most region 430 of a 23-gauge hypotube having an inner diameter of about 0.01 12" and an outer diameter of 0.025" can be ground down to an outer diameter of 0.015". In some embodiments, grinding down the hypotube can produce a proximal-most region 432 that is about 4.2X stiffer than the distal-most region 430. In some variants, the outer sheath 426 has a continuous taper from the distal terminus of the proximal-most region 432 to the distal terminus of the outer sheath 426 such that there is not a separate intermediate and distal-most region (such as shown in FIG. 5B). In other variants, the outer diameter of the outer sheath 426 does not vary or taper along its length.

[0042] The outer sheath 426 can be configured to circumferentially surround all or at least a portion of the length of the elongate member, including all or a portion of the length of the tines 424. The outer sheath 426 can be configured to be longitudinally movable with respect to the elongate member 440. For example, the delivery device 400 can be configured so that a compression spring pushes against the outer sheath 426 in the distal direction, thereby pushing the outer sheath 426 over at least a portion of the tines 424 until ready for deployment of the implant 100 held by the tines 424. The outer sheath 426 can be retracted proximally by compressing the compression spring, thereby uncovering a greater portion of the distal portion of the tines 424 of the elongate member 440. In certain variants, the elongate member 440 can be configured to be longitudinally movable with respect to the outer sheath 426. In other words, the delivery device 400 can be configured so that the elongate member 440 (and thus the tines 424) are pushed distally out of the outer sheath 426 rather than the outer sheath 426 being retracted proximally to cause deployment of the tines 424.

[0043] As shown in FIG. 5A, the tines 424 of the grasper can be configured to splay radially away from a central axis 421 of the elongate member as the outer sheath 426 is retracted proximally, thereby resulting in a longer portion of the tines 424 extending distally out from the outer sheath 426. The distal-most portion of the tines 424 can be curved toward the central axis 421. For example, a tip portion 434 of each tine 424 can be bent inward with respect to a proximal portion 436 of the tine 424, thereby forming a less than 180° angle between the radially mward surfaces of tip portion 434 and the proximal portion 436. For the tines 424 illustrated in FIG. 5 A, the radially inward surfaces of tip portion 434 and proximal portion 436 form an angle therebetween of about 170°. In some variants, this angle can be between about 150° and about 178°. For example, this angle can be at least about: 1 60°, 1 65°, 170°, or 175°. Curving the distal-most portion, or tip portion 434 of the tines 424 can improve the ability of the tines 424 to grip the implant 100.

[0044] The tip portion 434 can have a length that is approximately equal to the length of the snorkel 210 of the implant 100, as illustrated in FIG. 5A. The entire length of the tip portion 434 can engage the implant 100 when the implant 100 is loaded in the delivery device 400. In some variants, only a part of the length of the tip portion 434 engages the implant 100 when the implant 100 is loaded in the deliver)' device 400. A ratio can be defined between the length of the tip portion 434 that engages the implant 100 when the implant 100 is loaded in the deliver}' device 400 and the entire length of the tip portion 434. This ratio of length of the tip portion 434 to overall tine length can range between 1 :6 and 1 :2 (for example, 1 :6, 1 :5, 1 :4, 1 :3, 1 :2), values between the aforementioned values, and otherwise. In a preferred embodiment, the ratio is about 1 :4.

[0045] As illustrated in FIGS. 4 and 5A, the tines 424 can have a retracted position (shown in FIG. 4) and a deployed position (shown in FIG. 5A), with the tines 424 extending distally further beyond the outer sheath 426 in the deployed position than in the retracted position. In the retracted position, the distal-most surface of the tines 424 will be a first longitudinal distance away from the distal-most surface of the outer sheath 426. In the deployed position, the distal-most surface of the tines 424 will be a second longitudinal distance away from the distal-most surface of the outer sheath 426. A retraction distance can be defined as the difference between the first and second longitudinal distances. In some variants, the retraction distance can be between about 0.030" and about 0.060". For example, the retraction distance can be at least about: 0.040", 0.045", or 0.050". A ratio can be defined between the retraction distance and the length of the tip portion 434. This ratio can range from 1.5 - 6.0 (e.g., about 1.5, 3.0, 3.5, 4.0, 6.0), values between the aforementioned values, and otherwise.

[0046] As best shown in FIG. 4, the deliver}' device 400 can be configured so that the tip portions 434 of the tines 424 compress against the proximal portion 2ΘΘ of the implant 100 when the tines 424 are drawn in toward the outer sheath 426. In this way, the tines 424 can secure the implant 100 to the deliver}' device 400. Referring to FIG. 5A, the tip portions 434 of the tines 424 move radially away from the implant 100 as the proximal portions 436 of the tines 424 are moved longitudinally out with respect to the outer sheath 426 as a result of movement of either the outer sheath 426 in a proximal direction or of the elongate member in a distal direction. In this way, the tines 424 can be actuated to release the implant 100 from the deliver}' device 400 by retracting the outer sheath 426 or by pushing the tines 424 distally out from the outer sheath 426.

[0047] FIG. 6 is a cross-sectional side view of the distal portion 422 of the elongate delivery assembly 420. As illustrated in FIG. 6, the tines 424 of the grasper can be coupled (e.g., attached, adhered, molded, welded) to an elongate member 440 (e.g., rod or hypotube) by a coupling member 442. In other embodiments, the tines 424 of the grasper are integrally formed in a distal end portion of the elongate member 440 (e.g., laser cut, etched or otherwise formed in a solid rod or hollow tube). The elongate member 440 can be configured to move the tines 424 longitudinally along the central axis 421 of the elongate delivery assembly 420. As discussed above, as the tines 424 move longitudinally out from the outer sheath 426 as a result of movement of the elongate member 440, the tines 4:24 move radially away from the central axis 421, thereby causing the tmes 424 to release the implant 100,

[ 0048] FIGS. 7A asid 7B are side views of the actuator 4S0 of the delivery device 400. The actuator 450 can include an external surface 452 and an internal surface 454. The internal surface 454 can be configured to push against a cam 460 when the external surface 452 is pressed toward the housing (e.g., toward a central longitudinal axis) of the delivery device 400. The cam 460 can have a bearing surface 462 that contacts the internal surface 454 of the actuator 450. In some variants, the bearing surface 462 may be a ledge that is substantially perpendicular to a medial plane of the actuator 450. As shown in FIGS. 7A and 7B, the delivery device 400 can be configured so that the actuator 450 causes the cam 460 to rotate about a pivot 464 as the actuator 450 is pressed toward the housing of the delivery device 400. The distance between the pivot 464 and the point of contact between the internal surface 454 and the bearing surface 462 can be selected to improve control of the actuator 450 over retraction of the tines 424. For example, increasing this distance increases the mechanical advantage of the actuator 450 over the cam 460. In some variants, the bearing surface 462 can be configured so that the actuator 45Θ can be depressed to a depth of about 0.5 mm by applying a compressive force of about 0.3 Ibf to the actuator 450. The compressive force can increase linearly across this 0.5 mm range such that a compressive force of 0.15 Ibf depresses the actuator 450 about 0.25 mm toward the housing. In this way, the cam 460 can be designed to improve physician control over implant deployment and retrieval. The cam 460 can be manufactured so that no parting lines are on the bearing surface 462. Parting lines can interfere with the function of the actuator 450 by blocking the progression of the internal surface 454 over the bearing surface 462, thereby causing the actuator 450 to stick.

[0049] The cam 460 can be configured to cause the outer sheath 4:26 to retract in the proximal direction when the actuator 450 is depressed into the housing of the delivery device. For example, the cam 460 can comprise an internal cam (not shown) that engages a bearing surface (not shown) of the outer sheath 426. As the cam 460 rotates, the contact point between the internal cam and the bearing surface of the outer sheath 426 can shift, thereby causing the outer sheath 426 to move longitudinally in the proximal direction along the central axis of the elongate member 440. The delivery device 400 can include a compression spring that engages a part of the outer sheath 426, causing the compression spring to further compress as the outer sheath 426 moves proximally. When the actuator 450 is released, the compression spring can push the outer sheath 426 in the distal direction. Because the tines 454, when gripping the implant 100, extend radially outward beyond the inner surface of the outer sheath 426, the compression spring cannot force the outer sheath 426 over the tines 424. Accordingly, the spring cannot relax completely but rather will cause the outer sheath 426 to exert a force on the tines 424, causing the tines 424 to grip the implant 100. [0050] In some variants, the elongate member 440 is longitudinally movable with respect to the outer sheath 426. The cam 460 can be configured to cause the elongate member 440 to move longitudinally toward the open distal end of the outer sheath 426 as the cam 460 rotates about the pivot 464. For example, the cam 460 can include an internal cam (not shown) that engages a bearing surface (not shown) of the elongate member 440. As the cam 460 rotates, the contact point between the internal cam and the bearing surface of the elongate member 440 can shift, thereby causing the elongate member 440 to move longitudinally along the central axis of the elongate member 440. In this way, the actuator 450 can be configured to cause the elongate member 440 to move in a longitudinal direction when the actuator 450 is pressed toward the housing of the delivery device 400. Because the tines 454 can be coupled to the elongate member 440 (as shown in FIG. 4), the tines 454 can be configured to move longitudinally out from the outer sheath 426 when the actuator 450 is pressed toward the housing of the delivery device 400. Accordingly, the actuator 450 can be configured to cause the delivery device 400 to release the implant 100 when the actuator 450 is pressed toward the housing (e.g., toward a central longitudinal axis) of the main body or handpiece 410 of the deliver}' device 400.

Method of Insertion or Implantation

[0051] The surgical anatomy relevant to the systems, devices and methods described herein is illustrated in FIG. 8. Generally, FIG. 8 shows the anterior chamber 35, Schlemm's canal 30, collector ducts 32, the iris 40, cornea 45, trabecular meshwork 50, pupil 65, and lens 70. FIG. 9 illustrates the surgical placement or implantation of an illustrative embodiment of the implant 100, with the relevant anatomic relationships. It should be noted that the implant 100 is designed so that placement of the distal portion 300 withm Schlemm's canal 30 results in an orientation of the proximal portion 200 within the anterior chamber 35 withm the angle defined by the iris 40 and the inner surface of the cornea 45. Therefore, if the plane defined by Schlemm's canal is defined as zero degrees, the proximal portion 200 can extend therefrom at an angle of between about +60 degrees towards the cornea 45 or -30 degrees toward the ins 40, more preferably in the range of 0 to +45 degrees. This range may vary in individuals having a slightly different location of Schlemm's canal 30 relative to the limbal angle of the anterior chamber 35. [0052] Referring to FIG. 8, the surgical procedure to insert the implant 100 may include an approach through a corneal incision (for example 1.5 mm incision) at or near a limbus. In some embodiments, the deliver device 400 is used to make an incision through the cornea 45 to gain access to the anterior chamber 35. In some variants, a device other than the delivery device 400 is used to make the incision through the cornea 45, with the delivery device 400 then being passed through the corneal incision and into the anterior chamber 35. In some embodiments, the implant 100 is configured to be inserted in conjunction with a cataract treatment procedure and the elongate delivery assembly 420 of the delivery device 400 carrying implant 100 can be inserted through a phacoemulsification opening formed previously in conjunction with the cataract treatment procedure. Viscoelastic may optionally be introduced into the anterior chamber 35 prior to introduction of the delivery device 400 into the anterior chamber 35. In some implementations, the anterior chamber angle is viewed under high magnification using a gomopnsm or other gonioscopic device.

[0053] In some embodiments, the elongate delivery assembly 420 is advanced through the corneal incision and across the anterior chamber 35 of the eye toward the trabecular meshwork 50 (for example, enters into the anterior chamber through a temporal corneal incision and is advanced to the opposite nasal anterior chamber angle). In one embodiment, the upper third of the trabecular meshwork 50 is approached at about a 15- degree angle. The implant 100 may be positioned parallel to the trabecular meshwork 50. As illustrated in FIG. 8 (and better shown in FIG. 4), the implant 100 can be held by the tines 424 at the distal end of the elongate delivery assembly 420, with the cutting tip 304 of the implant 100 being positioned outside of the outer sheath 426. The cutting tip 304 can be used to pierce the trabecular meshwork 50 and the distal portion 300 of the implant 100 can be slid through the trabecular meshwork 50 and into Schlemm's canal 30. The handpiece 410 of the deliver}' device 400 can be rotated to help position the distal portion 300 of the implant 100 mto Schlemm's canal 30. The implant 100 can be positioned so that the distal portion 300 is in Schlemm's canal 30 and the inlet opening 216 is in the anterior chamber 35. Blood reflux may provide an indication that the implant 100 is in a proper position within Schlemm's canal 30 due to backflow of blood from the episcleral veins to Schlemm's canal [0054] Once the implant 100 is correctly positioned within Schlemm's canal 30, the actuator 450 can be activated (e.g., pressed into the housing of the delivery device), causing the delivery device 400 to release the implant 100, as described above, in some embodiments, the actuator 450 is released and a clinician may tap the side of the snorkel 210 to ensure that the implant is properly seated. The implant 100 can be positioned so that the protrusion 320 contacts the outer wall of Schlemm's canal In some variants, the concave surface 314 of the distal portion 300 is faced toward a radially outward portion of Schlemm's canal 30, thereby preventing or reducing blockage of the ostia of collector channels or ducts 32 extending from Schlemm's canal 30. In some variants, the protrusions 320 are configured to create a gap between the concave surface 316 of the distal portion 300 and a radially outward portion of Schlemm's canal 30, thereby preventing or reducing blockage of the ostia of collector channels 32 extending from Schlemm's canal 30. In accordance with several embodiments, the implant 100 is positioned to be parallel with the iris plane and with the snorkel opening perpendicular to the trabecular meshwork 50.

[0055] The delivery device 400 can then be withdrawn from the anterior chamber 35 through the corneal incision, leaving the implant 100 implanted in the eye tissue, as shown in FIG. 10. In embodiments where viscoelastic has been introduced, the viscoelastic may then be removed. In some implementations, the implant 100 can be re-captured by the grasper or plurality of tines 424 either during the same implantation procedure for repositioning or during a subsequent procedure to remove or re-position the implant 100. For example, the implant 100 can be moved to a different location if a more desirable location is identified or if a more problematic blockage site is identified (e.g., by visualization, imaging or other diagnostic methods performed either in real-time or subsequent to the procedure) or if it is later determined that the implant 100 should be removed (for example, symptoms of an ocular disorder have abated or have resolved more than desired). In some variants, the tines 424 can recapture the implant 100 by deploying the tines 424 so that the tip portions 434 of the tines 424 extend radially beyond the outer dimension of the snorkel 210 of the implant 100. The deliver}' device 400 can then be positioned so that the snorkel 210 is surrounded by the tip portions 434 of the tmes 424. The outer sheath 426 can then be advanced distallv over the tines 424 so that the tip portions 434 of the tines 424 move radially inward and close around the snorkel 210, thereby gripping the snorkel 210 and securing the implant 100 to the delivery device 400.

[0056] In some embodiments, the delivery device 400 is disposed of after a single use. In some variants, the delivery device 400 is reusable. For example, the delivery device 400 can be configured to allow the implant 100 or other separate implants to be loaded or reloaded into the deliver}' device 400. The delivery device 400 can be configured to be used with shunts, stents or other implants other than implant 100 and/or to deliver implants to locations other than Schlemm's canal 30. For example, the deliver}' device 400 can be used to deliver implants (e.g., shunts or stents) directly to a collector duct or channel 32 branching off of Schlemm's canal 30, to a supraciliary space, to a suprachoroidal space and/or to a subconjunctival space.

Certain Terminology

[0057] Although the shunt, delivery device, and methods have been disclosed in the context of certain embodiments and examples, it will be understood by those skilled in the art that the apparatuses and methods extend beyond the specifically disclosed embodiments to other alternative embodiments and/or uses of the embodiments and certain modifications and equivalents thereof.

[0058] Certain features that are described in this disclosure in the context of separate implementations can also be implemented in combination in a single implementation. Conversely, various features that are described in the context of a single implementation can also be implemented in multiple implementations separately or in any suitable subcombination. Moreover, although features may be described above as acting in certain combinations, one or more features from a claimed combination can, in some cases, be excised from the combination, and the combination may be claimed as any subcombination or variation of any subcombination.

[0059] Terms of orientation used herein, such as "top," "bottom," "proximal," "distal," "longitudinal," "lateral," and "end" are used in the context of the illustrated embodiment. However, the present disclosure should not be limited to the illustrated orientation. Indeed, other orientations are possible and are within the scope of this disclosure. Terms relating to circular shapes as used herein, such as diameter or radius, should be understood not to require perfect circular structures, but rather should be applied to any suitable structure with a cross-sectional region that can be measured from side-to-side. Terms relating to shapes generally, such as "circular" or "cylindrical" or "semi-circular" or "semi- cylindrical" or any related or similar terms, are not required to conform strictly to the mathematical definitions of circles or cylinders or other structures, but can encompass structures that are reasonably close approximations.

[0060] Conditional language, such as "can," "could," "might," or "may," unless specifically stated otherwise, or otherwise understood within the context as used, is generally intended to convey that certain embodiments include or do not include, certain features, elements, and/or steps. Thus, such conditional language is not generally intended to imply that features, elements, and/or steps are in any way required for one or more embodiments.

[0061] Conjunctive language, such as the phrase "at least one of X, Y, and Z," unless specifically stated otherwise, is otherwise understood with the context as used in general to convey that an item, term, etc. may be either X, Y, or Z. Thus, such conjunctive language is not generally intended to imply that certain embodiments require the presence of at least one of X, at least one of Y, and at least one of Z.

[0062] The terms "approximately," "about," and "substantially" as used herein represent an amount close to the stated amount that still performs a desired function or achieves a desired result. For example, in some embodiments, as the context may dictate, the terms "approximately", "about", and "substantially" may refer to an amount that is within less than or equal to 10% of the stated amount. The term "generally" as used herein represents a value, amount, or characteristic that predominantly includes or tends toward a particular value, amount, or characteristic. As an example, in certain embodiments, as the context may dictate, the term "generally parallel" can refer to something that departs from exactly parallel by less than or equal to 20 degrees.

[0063] Some embodiments have been described in connection with the accompanying drawings. The figures are to scale, but such scale should not be limiting, since dimensions and proportions other than what are shown are contemplated and are within the scope of the disclosed invention. Distances, angles, etc. are merely illustrative and do not necessarily bear an exact relationship to actual dimensions and layout of the devices illustrated. Components can be added, removed, and/or rearranged. Further, the disclosure herein of any particular feature, aspect, method, property, characteristic, quality, attribute, element, or the like in connection with various embodiments can be used in all other embodiments set forth herein. Additionally, it will be recognized that any methods described herein may be practiced using any device suitable for performing the recited steps.

[0064] In summary, various embodiments and examples of devices and methods have been disclosed. Although the devices and methods have been disclosed in the context of those embodiments and examples, this disclosure extends beyond the specifically disclosed embodiments to other alternative embodiments and/or other uses of the embodiments, as well as to certain modifications and equivalents thereof. This disclosure expressly contemplates that various features and aspects of the disclosed embodiments can be combined with, or substituted for, one another. Accordingly, the scope of this disclosure should not be limited by the particular disclosed embodiments described above, but should be determined only by a fair reading of the claims that follow.

Claims

WHAT IS CLAIMED IS:

1 , An ocular implant delivery system comprising:

an implant comprising:

a proximal portion comprising a snorkel sized to be received within an anterior chamber of an eye, the snorkel circumferentially surrounding a channel extending therethrough; and

a distal portion extending at an angle from the proximal portion and shaped to be received withm a portion of Schlemm's canal, the distal portion having a longitudinal axis and a curved radially inward surface that only partially surrounds the longitudinal axis; and

a delivery device comprising:

a handpiece comprising a proximal end, a distal end and a main body- between the proximal end and the distal end; and

a delivery assembly positioned partially within the mam body of the handpiece and extending beyond the distal end of the handpiece, the delivery assembly comprising:

an elongate member, a distal end portion of the elongate member including a grasper comprised of a plurality of tines, each tine having a proximal portion and a distal portion, the distal portion of each tine being biased to splay radially outward relative to the proximal portion of the tine in an unconstrained configuration, and the distal portion of each tine being bent at an angle with respect to the proximal portion; and

an outer sheath circumferentially surrounding the elongate member, the outer sheath being longitudinally movable with respect to the elongate member, wherein an outer dimension of a distal-most portion of the outer sheath is smaller than an outer dimension of a proximal portion of the outer sheath; and

wherein the grasper is configured to securely retain the snorkel of the implant until deployment, and wherein the main body of the handpiece further comprises an actuator configured to move the outer sheath longitudinally with respect to the elongate member to effect unsheathing and resheathing of at least a portion of the grasper, thereby facilitating deployment and re-capture of the implant.

2. The delivery system of claim 1 , wherein the implant further comprises a cutting tip disposed on a distal-most surface of the implant.

3. The deliver system of claim 2, wherein the cutting tip is adapted to pierce a trabecular meshwork.

4. The delivery system of claim 1, wherein the plurality of tines have a retracted position and a deployed position, the tines extending further out of the outer sheath in the deployed position than in the retracted position.

5. The delivery system of claim 4, wherein the actuator is configured to cause the tmes to transition between the retracted and deployed positions by causing the outer sheath to move longitudinally toward a proximal end of the handpiece until at least the distal portion of each tine is advanced out of the outer sheath.

6. The delivery system of claim 4, wherein the plurality of tines are configured to secure the implant to the delivery device when the tines are in the retracted position.

7. The deliveiy system of claim 6, wherein the plurality of tines are configured to release the implant when the tines are in the deployed position.

8. The deliver)' system of claim 1, wherein the delivery assembly further comprises a cam coupled to the actuator and to a proximal end of the outer sheath, wherein the cam comprises a bearing surface and a pivot, and wherein the cam is configured to rotate about the pivot when the actuator is depressed, thereby causing the outer sheath to retract in a longitudinally proximal direction.

9. The deliveiy system of claim 1, wherein the elongate member comprises a hypotube.

10. The delivery system of claim 1, wherein the length of the distal portion of each tine compared to the overall length of the tine is about 1 :4.

1 1. The deliver}' system of claim 4, wherein the difference in distance between the distal-most surface of the plurality of tines and the distal terminus of the outer sheath is between 0.030" and 0.060".

12. A deliver}' device for delivering an implant into ocular tissue, the delivery device comprising:

a handpiece comprising a proximal end, a distal end and a mam body between the proximal end and the distal end; and

a delivery assembly positioned partially within the main body of the handpiece and extending beyond the distal end of the handpiece, the delivery- assembly comprising:

an elongate member, a distal end portion of the elongate member comprising of a plurality of tines, each tine having a proximal portion and a distal portion, the distal portion of each tine being biased to splay radially outward relative to the proximal portion of the tine when the plurality of tines are unsheathed, and the distal portion of each tine being bent at an angle with respect to the proximal portion; and

an outer sheath circumferential ly surrounding the elongate member, the outer sheath being longitudinally movable with respect to the elongate member, wherein an outer dimension of a distal-most portion of the outer sheath is smaller than an outer dimension of a proximal portion of the outer sheath,

wherein the plurality of tines is configured to securely retain at least a portion of an implant until deployment, and

wherein the main body of the handpiece further comprises an actuator configured to move the outer sheath longitudinally with respect to the elongate member to effect unsheathing and resheathmg of at least a portion of the plurality of tines, thereby facilitating deployment and re-capture of the implant.

13. The deliver}' device of claim 12, wherein the distal portion of each tine extends at an angle with respect to the proximal portion of each tine.

14. The delivery device of claim 12, wherein a wall thickness of the distal-most portion of the outer sheath is less than a wall thickness of the proximal portion of the outer sheath.

1 5. The deliver device of claim 12, wherein the proximal portion of the outer sheath has a stiffness that is greater than a stiffness of the distal-most portion of the outer sheath.

16. The delivery device of claim 12, wherein the actuator comprises a push button.

17. The deliver}' device of claim 16, wherein the delivery assembly further comprises a cam coupled to the actuator and to a proximal end of the outer sheath, wherein the cam comprises a bearing surface and a pivot, and wherein the cam is configured to rotate about the pivot when the actuator is depressed, thereby causing the outer sheath to retract in a longitudinally proximal direction.

18. The delivery device of claim 12, wherein the plurality of tines consists of only four tmes.

19. The delivery system of claim 1 , wherein the length of the distal portion of each tine compared to the overall length of the tine is about :4.

20. The delivery system of claim 4, wherein the difference in distance between the distal-most surface of the plurality of tines and the distal terminus of the outer sheath is between 0,030" and 0.060".