Ocular delivery systems and methods

Abstract

Disclosed herein is a device for delivering fluid to an eye. The device may include a handle with a housing at least partially containing a fluid reservoir therein, a cannula coupled to a distal end of the housing, and an elongated member slidably positioned within the cannula. The device may include a connector releasably coupled to the fluid reservoir in the handle, the connector configured to receive an external fluid device to transfer fluid into the fluid reservoir and to be released from the handle with the external fluid device coupled to the connector. The cannula may include a curved proximal portion having a first radius of curvature, a curved distal portion having a second radius of curvature, and a distal tip, the first radius of curvature being greater than the second radius of curvature, and the first and second radii of curvature being in opposite directions.

Description

[Technical Field]

[0001] (Incorporated by reference) This application claims priority to U.S. Provisional Patent Application No. 63 / 400,267, filed August 23, 2022, the entire contents of which are incorporated herein by reference.

[0002] FIELD OF THE INVENTION The present invention relates generally to fluid delivery systems for treating ocular conditions and associated methods for treating such ocular conditions. [Background technology]

[0003] Glaucoma is a potentially blinding disease that affects over 60,000,000 people worldwide, or approximately 1-2% of the population. Glaucoma is typically characterized by elevated intraocular pressure. Increased pressure within the eye can cause irreversible damage to the optic nerve, which, if left untreated, can lead to vision loss and even progression to blindness. Consistent reduction of intraocular pressure can slow or halt the progressive loss of vision associated with glaucoma.

[0004] Elevated intraocular pressure is generally caused by suboptimal outflow or drainage of fluid (aqueous humor) from the eye. Aqueous humor is a clear, colorless fluid that is continuously replenished in the eye. Aqueous humor is produced by the ciliary body and then ultimately exits the eye primarily through the trabecular meshwork. The trabecular meshwork extends around the eye at the anterior chamber angle or drainage angle, which is formed at the intersection between the peripheral iris or iris root, the anterior sclera or scleral spur, and the peripheral cornea. The trabecular meshwork extends outward into Schlemm's canal, a narrow peripheral passageway that generally surrounds the outer boundary of the trabecular meshwork. Aqueous veins or collecting ducts that receive the drained fluid are positioned around Schlemm's canal and extend radially therefrom. Net drainage or outflow of aqueous humor can be reduced as a result of reduced ease of outflow, reduced outflow through the trabecular meshwork and Schlemm's canal drainage system, increased episcleral venous pressure, or possibly increased aqueous humor production. Outflow from the eye can also be restricted by blockages or narrowings in the trabecular meshwork and / or Schlemm's canal and its collecting canals.

[0005] Glaucoma, pre-glaucoma, and ocular hypertension can currently be treated by lowering intraocular pressure using one or more therapies, including medications, incisional surgery, laser surgery, cryosurgery, and other forms of surgery. Generally, medications or medical treatments are the first-line treatments. If medical treatments are not sufficiently effective, more invasive surgical treatments may be used. For example, a standard open surgical treatment for lowering intraocular pressure is trabeculectomy or filtration surgery. This procedure involves creating a new drainage site for aqueous humor. Instead of draining naturally through the trabecular meshwork, a new drainage pathway is created by removing a portion of the sclera and trabecular meshwork at the drainage angle. This creates an opening or passageway between the anterior chamber and the subconjunctival space, which is drained by conjunctival blood vessels and lymphatics. The new opening can be covered by the sclera and / or conjunctiva to form a new reservoir, called a bleb, through which aqueous humor can drain. However, traditional trabeculectomy carries both short- and long-term risks. These risks include occlusion of the surgically created opening due to scarring or other mechanisms, low or abnormally low intraocular pressure, drainage hemorrhage, iris hemorrhage, intraocular infection or endophthalmitis, shallow anterior chamber angle, macular hypotony, choroidal exudation, and suprachoroidal hemorrhage.

[0006] One alternative is to implant a device into Schlemm's canal that maintains its patency or aids in the flow of aqueous humor from the anterior chamber into the canal. Various stents, shunts, catheters, and procedures have been devised for this purpose, employing an ab-externo (from outside the eye) approach to deliver the implant or catheter into Schlemm's canal. This placement method is invasive and typically time-consuming, requiring the creation of tissue flaps and deep incisions to access the canal. Additionally, Schlemm's canal has a small diameter, e.g., approximately 50-250 microns in cross-sectional diameter, which can become even smaller when collapsed, making it very difficult for many surgeons to find and access it from this external incision approach. One related non-implantation procedure, abexternocanaloplasty, involves creating a deep scleral incision and flap, locating and opening Schlemm's canal, circumferentially encircling the canal 360 degrees from outside the eye with a catheter, and using viscoelastic sutures, circumferential tension sutures, or both to help maintain canal patency. This procedure is very difficult and can take anywhere from 45 minutes to 2 hours. Although the long-term safety and effectiveness of canaloplasty are very promising, the procedure remains surgically challenging and invasive.

[0007] Another alternative is viscocanalostomy, which involves injecting a viscoelastic solution into Schlemm's canal to dilate the Schlemm's canal and associated collecting canals. Dilation of the canal and collecting canals in this manner generally facilitates the drainage of aqueous humor from the anterior chamber through the trabecular meshwork and Schlemm's canal and out through the natural trabecular canalicular outflow pathway. Viscocanalostomy is similar to canaloplasty (both are invasive and externo), except that viscocanalostomy does not involve sutures and does not restore full 360-degree outflow function. Some advantages of viscocanalostomy are that a sudden drop in intraocular pressure, iris hemorrhage, hypotony, and a flat anterior chamber can be avoided. The risk of cataract formation and infection can also be minimized due to reduced intraocular manipulation, complete eyewall penetration, anterior chamber opening and shallowing, and the absence of iridectomy. An additional advantage of viscocanalostomy is that the procedure restores the physiological outflow pathway, thus avoiding the need for external filtration and its associated short- and long-term risks in most eyes. This makes the procedure successful, partially independent of conjunctival or scleral scarring, a major cause of failure in traditional trabeculectomy. Moreover, the absence of an elevated filtering bleb avoids the associated ocular discomfort and potentially devastating ocular infection, and the procedure can be performed in any quadrant of the outflow pathway.

[0008] However, ab externo viscocanalostomy and canaloplasty techniques remain highly invasive because access to Schlemm's canal must be created by making a deep incision in the sclera, creating a scleral flap, and opening the canal. "Ab externo" generally means "from the outside" and is inherently more invasive, given the location of Schlemm's canal and the amount of tissue disruption required to access it from the outside. On the other hand, "ab interno" means "from the inside" and is a less invasive approach because less tissue disruption is required to access it from the inside. As a result, the ab interno approach to Schlemm's canal provides surgeons with easier access to the canal, but also reduces risks to the patient's eye and reduces patient morbidity, all of which leads to improved patient recovery and rehabilitation. Ab externo viscocanalostomy and canaloplasty procedures also remain challenging for surgeons because, as previously mentioned, Schlemm's canal's small diameter makes it difficult to locate and access it from the outside using a deep incision approach. A further drawback remains that a viscocanalostomy typically dilates Schlemm's canal, a 360-degree ring-shaped outflow vessel-like structure, by up to 60 degrees. The more of the canal that can be dilated, the more aqueous humor outflow can be restored.

[0009] Therefore, it would be beneficial to have a system that provides easy and atraumatic access to Schlemm's canal using an abinterno approach for the delivery of tools and fluid compositions. It would also be useful to have a system that rapidly delivers tools and compositions to Schlemm's canal, reducing procedure time and infection risk without compromising the safety and precision of the delivery procedure. It would also be useful to have a system that delivers tools and fluid compositions into Schlemm's canal using an abinterno approach, so that both cataract surgery and glaucoma surgery can be accomplished during the same surgical procedure using the exact same corneal or scleral incision. Such incisions are smaller, allowing for minimally invasive surgery and faster patient recovery. This approach allows access to Schlemm's canal from inside the eye through the trabecular meshwork, hence the name "abinterno." Also desirable are methods for delivering tools and compositions that effectively disrupt the paracanalicular network and adjacent walls of Schlemm's canal, also known as the medial wall of Schlemm's canal, maintain the patency of Schlemm's canal, increase outflow, decrease resistance to outflow, or effectively dilate the canal and / or its collecting ducts using a system in a minimally invasive abinterno manner. Summary of the Invention [Means for solving the problem]

[0010] Disclosed herein is a device for delivering fluid to an eye. The device may include a handle including a housing containing a fluid reservoir, a cannula coupled to a distal end of the handle, and an elongated member slidably positioned within the cannula. The device may further include a connector releasably coupled to the fluid reservoir in the handle, the connector being configured to receive an external fluid device to transfer fluid into the fluid reservoir and to be released from the handle with the external fluid device coupled to the connector.

[0011] In some variations, the handle may include a proximal portion with a proximal cavity having a proximal opening, the proximal cavity having a coupling hub therein, the coupling hub including a coupling portion, and the connector may engage with the coupling portion of the coupling hub, the coupling portion including threads configured to engage a distal lumen wall of the connector.

[0012] In some variations, the handle may include a seal member distal to the coupling hub, the seal member configured to seal against the fluid reservoir.

[0013] In some variations, the connector may include a connector body including one or more extensions configured to engage one or more abutments in the proximal cavity of the handle when the connector is coupled to the coupling hub. The coupling hub may include a plug having a plug lumen in fluid communication with the fluid reservoir.

[0014] In some variations, the housing may comprise a distal portion of a handle, which may include a gripping portion proximal to the distal end of the handle.

[0015] In some variations, the gripping portion may include a textured surface having raised elements, recessed elements, or a combination thereof. The textured surface may include raised or recessed elements having the same shape. The textured surface may include raised or recessed elements having different shapes. The textured surface may include raised or recessed elements, where the raised or recessed elements have the same cross-sectional area or diameter, or different cross-sectional areas or diameters.

[0016] In some variations, the gripping portion may include a top surface and a bottom surface, and the top surface or the bottom surface may include one or more actuators.

[0017] The gripping portion may be symmetrical across the YZ plane, across the XZ plane, or across each of the YZ and XZ planes.

[0018] In some variations, the gripping portion may include a maximum height at one or more actuators and a maximum height proximal to the distal end of the handle.

[0019] In some variations, the grip portion may include two or more cross-sectional shapes along the longitudinal axis of the handle.

[0020] In some variations, the central section of the gripping portion may have an elliptical cross-sectional shape having a major axis and a minor axis, the central section of the gripping portion including a top surface, a bottom surface, and one or more actuators. The gripping portion may have a circular cross-sectional shape having a first diameter proximal to the central section and a second diameter distal to the central section, the first diameter being larger than the second diameter.

[0021] Also disclosed herein is a method of delivering fluid to treat an ocular condition. The method may include coupling an external fluid device to a delivery device, the delivery device may include a handle with a housing, a cannula coupled to the handle, a fluid reservoir, and an elongated member, the elongated member being in fluid communication with the fluid reservoir and slidably positioned within the cannula. The method includes delivering fluid from the external fluid device through the connector releasably coupled to the fluid reservoir contained within the delivery device housing, and detaching the connector from the delivery device with the external fluid device coupled to the connector. The method may further include advancing the cannula of the delivery device into the eye, advancing the elongated member around Schlemm's canal, and delivering fluid to the eye through the elongated member.

[0022] In some variations, removing the connector and the external fluid device coupled to the connector from the delivery device may include rotating the connector to remove the connector and the external fluid device from the delivery device. Removing the connector and the external fluid device coupled to the connector from the delivery device may include removing the connector from a proximal cavity in the handle. Removing the connector and the external fluid device coupled to the connector from the delivery device includes rotating the connector to disengage the connector from a coupling hub in the proximal cavity of the handle. Removing the connector and the external fluid device coupled to the connector from the delivery device includes rotating the connector using one or more tabs extending from the connector body in a second direction opposite the first direction.

[0023] Also disclosed herein is a device for delivering fluid to an eye. The device may include a handle containing a fluid reservoir and a cannula coupled to a distal end of the handle, the cannula having a curved proximal portion, a curved distal portion, and a distal tip, the curved proximal portion having a first radius of curvature and the curved distal portion having a second radius of curvature, the first radius of curvature being greater than the second radius of curvature, and the first and second radii of curvature being in opposite directions. The device may further include an elongate member slidably positioned within the cannula and configured to deliver fluid to Schlemm's canal.

[0024] The device further includes a distal tip further comprising a distal edge having a straight portion, a proximal edge having a curved portion, and a cannula lumen opening, hi some variations, the distal tip may be located on the inner radius of the cannula or on the outer radius of the cannula.

[0025] In some variations, the straight portion of the distal edge and the outer radius may form an angle of about 14 degrees to about 20 degrees. The distal edge or the proximal edge may be chamfered, or the distal edge and the proximal edge may be chamfered.

[0026] The distal edge may include an outer distal edge and an inner distal edge that define a tongue. The proximal edge may further include an inner proximal edge and an outer proximal edge that define a base. The distal edge may be rounded or straight.

[0027] In some variations, the diameter of the distal tip may taper from the proximal edge to the distal edge.

[0028] In some variations, the straight portion of the distal tip may comprise one or more straight segments. The straight portion of the distal tip may comprise multiple straight segments, each segment with a different slope.

[0029] In some variations, the curved portion of the distal tip may include one or more curved segments. The one or more curved segments may include multiple curved segments, each segment having a different radius of curvature. In some variations, the distal tip may have a length along the longitudinal axis from the distal edge to the proximal edge.

[0030] In some variations, the length of the straight portion may constitute a greater percentage of the length of the distal tip than the length of the curved portion, hi some variations, the length of the curved portion constitutes a greater percentage of the length of the distal tip than the length of the straight portion.

[0031] In some variations, the cannula may further include an outer wall and an inner wall defining a wall thickness. In some variations, the wall thickness tapers along the length of the distal tip. The wall thickness may taper along the length of the straight portion. In some variations, the wall thickness tapers along the length of the tongue of the straight portion. The wall thickness may be constant along the length of the distal tip. The wall thickness may be constant along the length of the straight portion. The wall thickness may be constant along the length of the tongue of the straight portion.

[0032] In some variations, the distal tip of the cannula may be aligned with or bisected by the central longitudinal axis of the handle, hi some variations, the curved proximal portion and the curved distal portion may be offset from the central longitudinal axis of the handle.

[0033] Also disclosed herein is a device for delivering fluid to an eye. The device may include a handle that at least partially houses a fluid reservoir therein, and the handle may include a housing having a proximal portion and a distal portion including a gripping portion. The gripping portion may include a first curved side, a second curved side opposite the first curved side, and a tapered region distal to the first and second curved sides, the tapered region configured to receive a user's finger. The device may further include a cannula coupled to a distal end of the handle and an elongated member slidably positioned within the cannula and configured to deliver fluid to Schlemm's canal.

[0034] In some variations, the first and second curved sides are convex. The first and second curved sides may be symmetrical about an XZ plane parallel to the longitudinal midpoint.

[0035] In some variations, the gripping portion may comprise an actuator configured to move the elongate member and / or deliver fluid. The gripping portion may further comprise an actuator boundary around the actuator.

[0036] In some variations, the grip portion may further comprise a planar surface proximal to the actuator. The planar surface may include a first planar surface, and the grip portion may further comprise a second planar surface, the first planar surface being at the top of the handle and the second planar surface being at the bottom of the handle. In some variations, the grip portion may comprise a neck proximal to the actuator.

[0037] In some variations, the proximal portion may have a first height at the distal end, the neck may have a second height, and the distal portion may have a maximum height aligned with at least a portion of the actuator, where the first height and the maximum height may be greater than the second height. In some variations, the grip portion may include a non-slip material on the tapered portion. The grip portion may include an actuator configured to move the elongated member and / or deliver a fluid, where the non-slip material extends beyond the actuator and terminates adjacent the distal end of the handle. The non-slip material may surround the tapered portion. [Brief explanation of the drawings]

[0038] [Figure 1] 1 shows a stylized cross-sectional view of the eye and some of the structures involved in the flow of aqueous humor from the eye. [Figure 2] 1 shows a perspective view of an exemplary delivery device. [Figure 3] 1 shows an exploded view of an exemplary delivery device variation. [Figure 4A] FIG. 4A shows a perspective view of a connector of a delivery system, and FIG. 4B shows a front view of the connector of FIG. 4A. [Figure 4B] FIG. 4A shows a perspective view of a connector of a delivery system, and FIG. 4B shows a front view of the connector of FIG. 4A. [Figure 5A] FIG. 1 shows a perspective view of an exemplary delivery device having a handle including a housing with a gripping portion. [Figure 5B] FIG. 5B shows a front view of the delivery device of FIG. 5A. [Figure 5C] 5B shows a side view of the exemplary delivery device of FIG. 5A. [Figure 6A] FIG. 10 shows a perspective view of the proximal end of the handle of the delivery device including the connector of the delivery system. [Figure 6B] 6B shows the proximal end of the handle of FIG. 6A, including the proximal opening. [Figure 6C] FIG. 6B shows a rear view of the proximal end of the handle of FIG. 6A. [Figure 7]1 illustrates a side view of an exemplary cannula of a delivery device. [Figure 8A] 1A and 1B show side views of exemplary variations of the cannula. [Figure 8B] 1A and 1B show side views of exemplary variations of the cannula. [Figure 8C] 1A and 1B show side views of exemplary variations of the cannula. [Figure 8D] 1A and 1B show side views of exemplary variations of the cannula. [Figure 8E] 1A and 1B show side views of exemplary variations of the cannula. [Figure 9A] 10 shows a variation of the distal tip of the cannula. [Figure 9B] FIG. 9B shows a side view of the distal tip of FIG. 9A, and FIG. 9C shows a side view of a variation of the distal tip of FIG. 9A. [Figure 9C] FIG. 9B shows a side view of the distal tip of FIG. 9A, and FIG. 9C shows a side view of a variation of the distal tip of FIG. 9A. [Figure 10] FIG. 1 shows a side view of the distal tip of the cannula. [Figure 11A] 10 shows a further variation of the distal tip of the cannula. [Figure 11B] 10 shows a further variation of the distal tip of the cannula. [Figure 11C] 10 shows a further variation of the distal tip of the cannula. [Figure 11D] 10 shows a further variation of the distal tip of the cannula. [Figure 11E] 10 shows a further variation of the distal tip of the cannula. [Figure 11F] 10 shows a further variation of the distal tip of the cannula. [Figure 11G] 10 shows a further variation of the distal tip of the cannula. [Figure 11H] 10 shows a further variation of the distal tip of the cannula. [Figure 11I] 10 shows a further variation of the distal tip of the cannula. [Figure 11J] 10 shows a further variation of the distal tip of the cannula. [Figure 11K] 10 shows a further variation of the distal tip of the cannula. [Figure 11L] 10 shows a further variation of the distal tip of the cannula. [Figure 12A] 1 illustrates an exemplary delivery device and a method of delivering fluid from an external fluid device to the delivery device, according to some variations. [Figure 12B] 1 illustrates an exemplary delivery device and a method of delivering fluid from an external fluid device to the delivery device, according to some variations. [Figure 12C] 1 illustrates an exemplary delivery device and a method of delivering fluid from an external fluid device to the delivery device, according to some variations. [Figure 13] 1 is a flowchart of an exemplary method for delivering fluid to Schlemm's canal using a variation of the delivery system described herein. [Figure 14A] 10A shows a side view of a distal end of an elongate member according to some variations. [Figure 14B] 10A shows a side view of a distal end of an elongate member according to some variations. [Figure 14C] 10A shows a side view of a distal end of an elongate member according to some variations. [Figure 14D] 10A shows a side view of a distal end of an elongate member according to some variations. [Figure 14E] 10A shows a side view of a distal end of an elongate member according to some variations. DETAILED DESCRIPTION OF THE INVENTION

[0039] Systems and methods are described herein for accessing Schlemm's canal, delivering a fluid composition therein, and / or disrupting the trabecular meshwork to reduce intraocular pressure and thereby treat ocular conditions. Fluids and certain system components, such as slidable elongate members (e.g., conduits), can be used to provide a force to disrupt trabecular canalicular tissue, including the trabecular meshwork, juxtacanalicular tissue, Schlemm's canal, and collecting canals. As used herein, the term "disrupt" refers to the delivery of a volume of fluid or system component that alters tissue in a manner that improves flow through the trabecular canalicular outflow pathway. Examples of tissue disruption include, but are not limited to, dilating Schlemm's canal, dilating the collecting canal, increasing the porosity of the trabecular meshwork, stretching the trabecular meshwork, creating microtears or perforations in the juxtacanalicular tissue, removing septa from Schlemm's canal, cutting, disrupting, or removing trabecular canalicular tissue, or a combination thereof.

[0040] To better understand the systems and methods described herein, it may be useful to explain some of the basic ocular anatomy. FIG. 1 is a stylized depiction of a normal human eye. The anterior chamber (100) is shown bounded on its front surface by the cornea (102). The cornea (102) is connected at its periphery to the sclera (104), a tough fibrous tissue that forms the eye's protective white shell. The trabecular meshwork (106) is located on the periphery of the anterior chamber (100). The trabecular meshwork (106) extends 360 degrees circumferentially around the anterior chamber (100). Located on the peripheral surface of the trabecular meshwork (106) is Schlemm's canal (108). Schlemm's canal (108) extends 360 degrees circumferentially around the meshwork (106). At the apex formed between the iris (110), retina (106), and sclera (104) is the anterior chamber angle (112).

[0041] The delivery system is generally configured for one-handed operation and control by a single operator and includes one or more features useful for easily accessing Schlemm's canal with minimal trauma. Once access to the canal is gained, the delivery system can deliver a fluid composition and / or rupture the trabecular meshwork. For example, the lumen (e.g., conduit) of the elongate member can be configured to deliver a fluid composition to the canal, and the body of the elongate member can be configured to cut or rupture the trabecular meshwork when the system is removed from the eye while the elongate member is extended from the cannula and within Schlemm's canal.

[0042] It should be understood that in some cases, the delivery systems described herein may be used solely to deliver a fluid composition to Schlemm's canal (e.g., using the body of the elongate member, rather than to separately disrupt the trabecular meshwork), or may be used solely to disrupt the trabecular meshwork (e.g., using the body of the elongate member) without delivering a fluid composition. Moreover, as noted above, in some cases, the delivery systems described herein may be used both to deliver a fluid composition to Schlemm's canal and to disrupt the trabecular meshwork.

[0043] In some variations, the methods described herein may include implanting a device completely or partially into Schlemm's canal in conjunction with delivering a fluid composition to Schlemm's canal and / or disrupting the trabecular meshwork. Once the device is implanted in the canal, it will generally be configured to maintain the patency of Schlemm's canal without substantially impeding transmural fluid flow across the canal. This may restore, enable, or enhance the normal physiological outflow of aqueous humor through the trabecular canalicular tissue. Ocular implants such as those disclosed in U.S. Pat. No. 7,909,789 and U.S. Pat. No. 8,529,622 may be delivered, each of which is incorporated herein by reference in its entirety. In some variations, the implants in U.S. Pat. No. 7,909,789 and U.S. Pat. No. 8,529,622 include a support having at least one fenestration that completely traverses the central core of Schlemm's canal without substantially impeding transmural or longitudinal fluid flow across or along Schlemm's canal. The ophthalmic device may also disrupt the juxtacanalicular trabecular meshwork or the inner wall of the adjacent Schlemm's canal. The ophthalmic device may also be coated with drugs useful for treating ocular hypertension, glaucoma or pre-glaucoma, infection, or scarring, neovascularization, fibrosis, or post-surgical inflammation. The ophthalmic device may also be formed to be solid, semi-solid, or bioabsorbable.

[0044] Delivery Devices and Systems The systems described herein may generally include a single-hand, single-operator controlled device and one or more external fluid delivery devices configured to deliver fluid to and releasably couple to the delivery device. The delivery device generally includes a handle having a gripping portion, a housing having an interior and a distal end, and a connector configured to be removably coupled to both the handle housing and one or more external fluid devices. The delivery device may include a cannula coupled to and extending from the distal end of the housing. The cannula may include a proximal end, a straight portion, and a distal portion, the curved portion having proximal and distal ends and one or more radii of curvature. In other variations, the entire cannula may be straight and thus not include a distal curved portion. The cannula may also include an internal lumen extending from the proximal end through the distal tip, the distal tip including an opening to the internal lumen.

[0045] The device may also generally include a drive assembly partially housed within the housing. In some variations, the drive assembly may include one or more gears that convert rotary motion to linear motion. The delivery device may also include a slidable elongate member coaxially disposed within the cannula lumen. In some variations, the slidable elongate member may include a lumen therethrough. The delivery device may also include a fluid assembly at least partially housed within the handle. Fluid compositions such as saline, viscoelastic fluids including viscoelastic solutions, air, and gases may be delivered using the delivery device of the system. Suitable markings, coloring, or indicators may be included on any portion of the delivery device of the system to aid in identifying the location or position of the distal end of the cannula and / or slidable elongate member.

[0046] In some cases, the systems described herein may be used to perform abinterno trabeculotomy, abinterno transluminal trabeculotomy, clear corneal trabeculotomy, clear corneal transluminal trabeculotomy, abinterno tubuloplasty, and / or clear keratotubuloplasty, and / or may be used to deliver a fluid composition to the anterior or posterior segment of the eye.

[0047] A portion of an exemplary delivery system is shown in FIG. 2. As shown therein, the delivery system (200) may include a delivery device (201) having a universal handle (202) comprising a housing (206) including a gripping portion (204). The housing (206) has a proximal end and a distal end. A cannula (208) comprising a distal tip (232) may be coupled to and extend from the distal end of the housing. The delivery device (201) may further include an elongate member (234) slidably positioned within the cannula (208). The distal tip (232) of the cannula (208) may be configured to provide a user with enhanced functionality in seating the cannula (208) in Schlemm's canal, as described in more detail herein. The delivery device (201) may further include a drive assembly substantially contained within the housing (206). The drive assembly can be configured to actuate movement of the elongate member (234) and / or deliver a fluid composition to the eye. For example, as shown in FIG. 2, the drive assembly can include one or more actuators (210) (e.g., one, two, three, four, or more), such as, for example, rotatable elements (e.g., wheels), slides, buttons, etc., the actuation (e.g., rotation, translation, depression) of which can advance and / or retract the slidable elongate member and / or deliver a fluid composition. In some variations, the one or more actuators (210) can extend outside the housing (206) to facilitate user access. For example, the one or more actuators (210) can extend outside the housing of the handle, such as on the opposite side of the handle, as shown in the variation shown in FIG. 2. Also, as described in more detail herein, the handle (202) is configured (e.g., size, shape (including curvature), portions / components of the handle (e.g., actuator, gripping portion), etc.) to fit ergonomically in the user's hand and provide easy and comfortable access to the actuator and rotation of the handle itself along the longitudinal axis of the handle, thus allowing the user to easily control the movement of the elongated member and / or fluid delivery.

[0048] The delivery device (201) of the delivery system (200) may further include a fluid assembly including a reservoir (212) having a proximal opening (214) and a connector (220) configured to releasably couple to the handle (202) of the delivery device (201). When the connector (220) is coupled to the handle (202), the proximal opening (214) of the reservoir (212) may be in fluid communication with the connector (220) such that a fluid composition may be delivered to the reservoir (212) through the connector (220). The connector (220) may be configured to removably couple to (e.g., be at least partially releasably received within) an external fluid device. In this manner, the connector (220) may be configured to allow a volume of the fluid composition to be easily transferred from the external fluid device to the reservoir (212). After transfer of a volume of fluid composition, connector (220) may be disconnected from delivery device (201) to aid in removing, releasing, or otherwise disconnecting the external fluid device from housing (206) of handle (202) of delivery device (201). Delivery system (200), including delivery device (201), is described in more detail herein.

[0049] The delivery systems described herein, or components thereof, may, in some variations, be completely disposable. In other variations, portions of the delivery system may be reusable (e.g., non-patient-contacting materials such as the handle (202)), while portions of the delivery system may be disposable (e.g., patient-contacting materials such as the cannula (208) and elongate member (234)). In yet other variations, the delivery systems described herein may be completely reusable.

[0050] External Fluidic Devices and Fluid Compositions In some variations, the external fluid device can be coupled to the connector to deliver the fluid composition to the delivery device. The external fluid device can include a syringe, vial, or another container used to store a fluid. The external fluid device can be provided as part of a delivery system in a kit, or the external fluid device can be provided separately by the user. In some variations, the external fluid device can be pre-loaded with a fluid composition and packaged, for example, in a kit, with the fluid composition disposed therein. In other variations, the external fluid device may not be pre-loaded, but instead packaged empty and loaded with a fluid composition by the user prior to the procedure. In these variations, the kits described herein can also include a separate fluid container (e.g., a vial, syringe) containing a fluid for use with the external fluid device and / or fluid delivery device described herein. The external fluid device can include volumetric markings. In some variations, the external fluid device can be partially or completely transparent or otherwise see-through to allow a user to easily distinguish a volume of fluid composition within the external fluid device.

[0051] The fluid composition may include fluid compositions including, but not limited to, saline and a viscoelastic fluid. The viscoelastic fluid may include hyaluronic acid, chondroitin sulfate, cellulose, derivatives or mixtures thereof, or solutions thereof. In some variations, the viscoelastic fluid may include sodium hyaluronate. Additionally or alternatively, the viscoelastic fluid may further include a drug. For example, the viscoelastic fluid may include a drug suitable for treating glaucoma, reducing or lowering intraocular pressure, reducing inflammation, fibrosis, angiogenesis, or scarring, and / or preventing infection. For example, in some variations, the viscoelastic fluid may include a therapeutic agent described herein, such as, but not limited to, a Rho kinase (ROCK) inhibitor, and agents for gene therapy, DNA, RNA, or stem cell-based approaches. The fluid composition may include a custom drug formulation.

[0052] Long and thin members 3 shows an exploded view of a variation of a delivery device. Some variations of delivery devices described herein may include an elongate member (308) coaxially disposed within a cannula lumen (310). In some variations, the elongate member (308) may include a conduit defining a lumen and may be configured to deliver one or more fluid compositions and / or disrupt the trabecular meshwork or other similar tissue. In other variations, the elongate member (308) may be solid without a lumen but still configured to disrupt the trabecular meshwork or other similar tissue.

[0053] The elongate member (308) may be coaxially disposed and slidably disposed within the cannula lumen (310) of the delivery system described herein. When the elongate member (308) is in a retracted position relative to the cannula (306), the distal end of the elongate member (308) may be located within (i.e., proximal to) the distal tip of the cannula (306). When the elongate member (308) is in an extended position relative to the cannula (306), the distal end of the elongate member (308) may be located outside (i.e., distal to) the distal tip of the cannula (306). The length of extension of the elongate member (308) beyond the distal tip of the cannula (306) may correspond to the distance around Schlemm's canal that can be traversed by the elongate member (308) (e.g., to disrupt Schlemm's canal and / or surrounding trabecular canalicular tissue and / or to deliver a fluid composition). When variations of the delivery systems described herein are used to deliver a fluid composition, the length traversed by the elongate member (308) can correspond to the length of the circumference of Schlemm's canal to which the fluid composition is delivered. When variations of the delivery systems described herein are used to mechanically disrupt or cut the trabecular meshwork independent of fluid delivery, the length traversed by the elongate member (308) can correspond to the length of the trabecular meshwork that is cut or disrupted. In some variations, this length can be from about 1 mm to about 50 mm. In some of these variations, the length can be about 10 mm to about 40 mm, about 15 mm to about 25 mm, about 16 mm to about 20 mm, about 18 mm to about 20 mm, about 19 mm to about 20 mm, about 18 mm to about 22 mm, about 20 mm, about 30 mm to about 50 mm, about 35 mm to about 45 mm, about 38 mm to about 40 mm, about 39 mm to about 40 mm, or about 40 mm. The elongate member (308) can be moved between the extended and retracted positions using a drive assembly of the delivery device, which is described in more detail herein.

[0054] The elongate member (308) may be sized to be advanced through the cannula (306) into a portion of Schlemm's canal (e.g., 0-360 degrees of the canal). In some cases, the outer diameter of the elongate member may be configured to disrupt trabecular canalicular tissue, stent, and / or tension the canal, and / or deliver a fluid composition. The elongate member (308) may be made from any suitable material that provides the desired flexibility and pushability for introduction of the elongate member through the eye wall, access to Schlemm's canal, and / or navigation through other ocular tissue structures. For example, the elongate member (308) may comprise a polymer, a polymer reinforced with a stiffening member such as a metal wire, braid, or coil, a polymer-metal composite, or a metal such as stainless steel, nickel, titanium, aluminum, a shape memory alloy (e.g., nitinol), or an alloy of any of the foregoing. Exemplary polymers include, but are not limited to, polycarbonate, polyetheretherketone (PEEK), polyethylene, polypropylene, polyimide, polyamide, polysulfone, polyether block amide (PEBAX), fluoropolymers, and nylon.

[0055] To facilitate access to Schlemm's canal, in some variations, it may be advantageous to coat all or a portion of the elongate member (308) with a lubricious coating (e.g., a lubricious polymer coating) to reduce friction between the body of the elongate member (308) and the cannula and / or ocular tissue as the elongate member (308) moves within the cannula and / or ocular tissue. In some variations, the lubricious coating may be hydrophilic. In other variations, the lubricious coating may be hydrophobic. Additionally or alternatively, in some variations, the elongate member (308) may be made of one or more materials that, when used as intended, have a lower coefficient of friction than the ocular tissue that the elongate member (308) will contact (e.g., tissue of Schlemm's canal) and / or a lower coefficient of friction than the material of the cannula.

[0056] In variations in which elongate member (308) is reusable, elongate member (308) may be made from a material that can be sterilized (e.g., via autoclave), such as a heat-resistant metal (e.g., stainless steel, aluminum, titanium). Elongate member (308) may be straight with sufficient flexibility and pushability to navigate the ring-shaped Schlemm's Canal, or may be pre-formed with a radius of curvature of approximately 2-10 mm or approximately 6 mm (i.e., the approximate radius of curvature of Schlemm's Canal in an adult) to more easily bypass Schlemm's Canal partially or entirely. In some variations, elongate member (308) may be configured to be advanced over or along a guidewire.

[0057] In some variations, it may be desirable for the elongate member (308) to have one or more features to improve visualization of the elongate member (308) as it is extended from the cannula (308). For example, the elongate member (308) may be colored (e.g., red, orange, yellow, green, blue, purple, etc.) and / or may have colored segments and / or distinguishable designs thereon spaced along the length of the elongate member (308). Additionally or alternatively, visualization may be improved using illuminated beacons, fiber optics, side-illuminating fiber optics, luminescence, fluorescence, etc. For example, an optical fiber may travel along the body of the elongate member (308) to deliver light to the distal tip of the elongate member (308), which may improve visualization of the distal tip of the elongate member (308) as it is advanced or retracted around Schlemm's canal. In other words, in some variations, a portion of the elongate member (308) (e.g., the distal end, the central portion) may be illuminated or otherwise equipped with an illumination device to assist in visualizing the movement of the elongate member (308) within Schlemm's canal.

[0058] In some variations, the elongate member (308) can be sized to be advanced atraumatically (e.g., without disrupting the trabecular meshwork) through Schlemm's canal. In other variations, the elongate member (308) can be sized to have an outer diameter sufficient to disrupt Schlemm's canal and the surrounding trabecular meshwork tissue. The outer diameter can range from about 25 microns to about 1000 microns, about 25 microns to about 500 microns, about 50 microns to about 500 microns, about 150 microns to about 500 microns, about 200 microns to about 500 microns, about 300 microns to about 500 microns, about 200 microns to about 250 microns, about 150 microns to about 200 microns, or about 180 microns to about 300 microns. In some cases, it may be beneficial for the elongate member to have an outer diameter of about 240 microns, although portions of the elongate member (e.g., the distal tip) may vary in size and shape.

[0059] In some variations, the distal end of the elongate member (308) may be configured as a curved tip, a compound curved tip, an atraumatic tip, an enlarged atraumatic tip, or the like to aid in the advancement of the elongate member (308) through Schlemm's canal. In some of these variations, the distal end may comprise a blunt, parasol-shaped atraumatic tip. In other variations, the distal portion of the elongate member (308) may optionally include disrupting components, such as notches, hooks, barbs, roughened surfaces, or combinations thereof, to disrupt the Schlemm's canal or the paratrabecular portion of the juxtatrabecular meshwork. One or more protrusions emanating from the elongate member (308) may further disrupt the paratrabecular portion of Schlemm's canal or the paratrabecular meshwork, thus increasing the permeability of aqueous humor through the trabecular meshwork and into Schlemm's canal. In some cases, the elongate member (308) may also deliver energy to the trabecular meshwork tissue (e.g., ultrasonic energy, radio frequency energy (e.g., for electrocautery, electroablation), electromagnetic radiation, light energy (e.g., via optical fiber)).

[0060] 14A-14E illustrate various variations of the distal end of the elongate member. The variations illustrated in FIGS. 14A-14E may facilitate access to and advancement through Schlemm's canal or other ocular tissue. For example, the configurations of the distal end of the elongate member illustrated in FIGS. 14A-14E may aid in advancing the distal end of the elongate member through an opening (e.g., an otomy) formed in the trabecular meshwork to access Schlemm's canal and / or may allow for easier advancement through Schlemm's canal once inserted therein.

[0061] As seen in FIG. 14A , the elongate member 1400A may include a distal end 1402A having a first length and a lumen opening 1406A in fluid communication with the lumen 1420A of the elongate member 1400A. The distal end 1402A may have a constant outer diameter 1408A along the first length, as shown in FIG. 14A . In some variations, the constant outer diameter 1408A of the distal end 1402A along the first length may be the same outer diameter as all or a portion of the remainder of the body of the elongate member 1400A, while in other variations, the outer diameter 1408A of the distal end 1402A of the elongate member 1400A may be different from the outer diameter of different portions of the body of the elongate member 1400A. In some variations, the distal end (1402A) may include a rounded distal edge (1412A).

[0062] In some variations, the distal end of the elongate member may not have a constant outer diameter along the length of the distal end. For example, as shown in FIG. 14B, the distal end (1402B) may have a bulbous shape such that the outer diameter of the distal end (1402B) varies along the length of the distal end. In some variations, the bulbous shape may be at least partially spherical. The distal end (1402B) may have a proximal outer diameter (1414B), an intermediate outer diameter (1416B), and a distal outer diameter (1418B), which in some variations may be the same as the outer diameter of the remainder of the body of the elongate member (1400B). The intermediate outer diameter (1416B) may be larger than both the proximal outer diameter (1414B) and the distal outer diameter (1418B). The distal outer diameter 1418B may correspond to the outer diameter of the distal-most portion of the distal end 1402B of the elongate member 1400B. In some variations, the proximal outer diameter 1414B and the distal outer diameter 1418B may be substantially the same diameter, while in other variations, these outer diameters may be different. For example, the proximal outer diameter 1414B may be smaller than the distal outer diameter 1418B, or the distal outer diameter 1418B may be smaller than the proximal outer diameter 1414B. The distal end 1402B of the elongate member 1400B may also include a rounded distal edge.

[0063] In some variations, the distal end of the elongate member may comprise a taper that terminates at the lumen opening. For example, as shown in FIG. 14C , the distal end (1402C) of the elongate member (1400C) may have a first outer diameter (1408C) at a first portion of the distal end (1402C) and a second, smaller outer diameter (1410C) at a second portion of the distal end (1402C), the second portion being distal to the first portion. The outer diameter of the distal end (1402C) of the elongate member (1400C) may decrease linearly between the first and second portions such that the distal end (1402C) comprises a beveled surface. The first outer diameter (1408C) may be the same as or different from (e.g., larger or smaller than) the outer diameter of the remainder of the elongate body, while the second outer diameter (1410C) may generally be smaller than the outer diameter of the remainder of the elongate body.

[0064] In some variations, the distal end may be configured as a combination of the configurations described above. For example, the distal end may include one or more bulbous portions, one or more tapered or beveled portions, and / or a rounded distal edge. For example, the distal end may include a proximal beveled portion, a central bulbous portion, and a distal beveled portion, with the bevel of the proximal portion being opposite to the bevel of the distal portion. In this manner, the outer diameter of the distal end at the proximal end of the proximal portion may be smaller than the maximum outer diameter of the bulbous portion, and the maximum outer diameter of the bulbous portion may be larger than the outer diameter at the distal end of the distal portion. In other variations, the distal end may include multiple beveled portions (e.g., two, three, four, five, or more) with different bevels. For example, FIG. 14D shows an exemplary variation in which the distal end (1402D) includes multiple beveled portions. As shown therein, the distal end (1402D) may include a proximal sloped portion (1416D) having a positive slope, a central sloped portion (1418D) having a negative slope, and a distal sloped portion (1420D) having a negative slope different from the negative slope of the central portion (e.g., a more negative slope). In this manner, the outer diameter of the distal end 1402D may vary (e.g., linearly) from the proximal outer diameter (1408D) to the first central outer diameter (1410D), the second central outer diameter (1412D), and finally the distal outer diameter (1414D), as measured at the locations of the slope changes. The first central outer diameter (1410D) may be larger than the proximal outer diameter (1408D), the second central outer diameter (1412D), and the distal outer diameter (1414D). The second central outer diameter (1412D) can be larger than the proximal outer diameter (1408D) and the distal outer diameter (1414D). In some variations, the proximal outer diameter (1408D) and the distal outer diameter (1414D) can be approximately equal, while in other variations, the proximal outer diameter (1408D) can be larger than the distal outer diameter (1414D). While described above as having a central tapered portion with a negative slope, it should be understood that in some variations, this portion may not have a negative slope and instead may have a constant outer diameter.

[0065] In some variations, as seen in FIG. 14E, the distal end (1402E) of the elongate member (1400E) may include a rounded distal end (1403E). Additionally, a distal end (1402E) with a rounded distal end (1403E) may be advantageous for incision access and tracking of the distal end (1402E) around Schlemm's canal. The rounded distal end (1403E) may be closed and may not include a single central lumen opening. Instead, the distal end (1402E) may include one or more offset or side openings (1426E) that are in fluid communication with the lumen of the elongate member (1400E). In some variations, the distal end may include both a central lumen opening on the distal-most surface and one or more offset or side openings, each of which may be in fluid communication with the lumen of the elongate member (1400E). In some variations, the one or more offset or side openings (1426E) may include a single offset or side opening or multiple offset or side openings (e.g., two, three, four, five, six, seven, eight, nine, or more). The one or more offset or side openings (1426E) may be positioned in any suitable location on or around the distal end (1402E). For example, the openings may be aligned along the circumference of the distal end, offset along the circumference of the distal end (e.g., alternately positioned above and below the circumference), positioned in multiple rings around the distal end, positioned randomly on the distal end, or have any other configuration suitable for fluid delivery. Each of the offset or side openings may be substantially the same size (e.g., have the same diameter) or may be different sizes (e.g., one or more of the offset or side openings may have a different diameter than another of the offset or side openings). When the distal end (1402E) of the elongate member (1400E) is deployed within Schlemm's canal, the one or more offset or side openings (1426E) may direct the fluid composition exiting the lumen of the elongate member toward the trabecular meshwork and / or in opposite directions toward the collecting canal.

[0066] Referring back to FIG. 3 , as described above, the elongate member (308) can include a conduit with a lumen. The elongate member (308) can be configured to deliver a fluid composition. The fluid composition can travel through the lumen of the elongate member (308) and be delivered through one or more openings in the lumen. The fluid composition can be used to disrupt the trabecular meshwork and other surrounding tissue.

[0067] In some variations, the distal end of the elongate member (308) may be configured or modified to aid in the delivery of the fluid composition into Schlemm's canal. For example, the distal end of the elongate member (308) may include a notch configured as a half-tube. In addition to, or alternative to, an opening at the distal tip, the elongate member (308) may optionally include multiple openings through its body (e.g., sidewall) spaced along the axial length of the elongate member (308). In this variation, the fluid composition may be delivered from a reservoir through the openings in the elongate member into Schlemm's canal. This lateral discharge of the fluid composition (e.g., a viscoelastic fluid) may, in some cases, enhance the breakdown of outflow tissue and increase its permeability to aqueous humor. It is understood that the openings may be of any suitable number, size, and shape and may be spaced along the axial length of the elongate member (including the distal tip) in any suitable manner.

[0068] Drive Assembly Delivery device (300) may generally include a drive assembly (320) configured to move elongate member (308) (e.g., a conduit) and / or deliver a fluid composition into Schlemm's canal. Drive assembly (320) may be at least partially contained within housing (304) and may include any suitable component or combination of components capable of providing versatile functionality to handle (302), as shown in FIG.

[0069] The drive assembly may convert an external input (e.g., movement of a user's thumb or finger) into movement of one or more components of the delivery system. More specifically, the drive assembly may extend the slidable elongate member (308) (e.g., a slidable conduit) distally from the cannula (306) and / or retract the slidable elongate member (308) proximally into the cannula (306). The drive assembly (320) may also, optionally, deliver the fluid composition from the fluid reservoir (332) through the elongate member (308) and / or the cannula (306).

[0070] Each of these effects (i.e., extension of the slidable elongate member (308), retraction of the slidable elongate member (308), and / or delivery of the fluid composition), or any combination of these effects, can be actuated using the same actuator or different actuators. Utilizing the same actuator can allow for easier and more accurate one-handed use of the delivery system. For example, if the actuator includes a rotatable element (such as one or more wheels (350), as in the variations described herein), rotating the rotatable element in a first direction can cause extension (e.g., advancement) of the slidable elongate member (308), and rotating the rotatable element in a second, opposite direction can cause retraction of the slidable elongate member (308). If the delivery system is configured to deliver a fluid composition, rotating the rotatable element (e.g., in the first and / or second direction) can also cause delivery of the fluid composition. Delivery of the fluid composition can be simultaneous with movement (e.g., advancement and / or retraction) of the slidable elongate member (308). In some of these examples, the fluid composition can be delivered to the portion of Schlemm's canal through which the slidable elongate member 308 is advanced. That is, the fluid composition can be delivered to the same arc length of Schlemm's canal as the elongate member 308 is extended. When the delivery of the fluid composition is simultaneous with the retraction of the elongate member 308, the fluid composition can take the place of the slidable elongate member 308 as it is retracted, dilating the Schlemm's canal and / or collecting ducts and / or juxtacanalicular network at that location within the Schlemm's canal. Furthermore, the amount of fluid composition delivered can be tied to the amount of movement of the elongate member 308. That is, for a certain amount of movement of the elongate member 308 (e.g., retraction distance) and a certain amount of rotation of the rotatable element, a certain predetermined amount of fluid composition can be delivered via the elongate member 308 (e.g., delivered from the distal end of the elongate member 308).

[0071] In other variations, the amount of fluid composition delivered may not be tied to the amount of movement of the elongate member. In other words, the amount of fluid composition delivered may be independent of the amount of movement of the elongate member. It can therefore be appreciated that there may be two separate actuators for moving the elongate member (308) and delivering the fluid composition. For example, a first actuator may be configured to advance and / or retract the elongate member (308), and a second actuator may be configured to deliver the fluid composition. If the first actuator comprises a rotatable element (e.g., one or more wheels (350)), rotating the rotatable element in a first direction may cause the slidable elongate member (308) to advance, and rotating the rotatable element in a second, opposite direction may cause the slidable elongate member (308) to retract. When the delivery system is configured to deliver a fluid composition, a second actuator may be engaged to cause delivery of the fluid composition. The second actuator may comprise a slidable or translatable element (e.g., a slide), a rotatable element, a depressible element (e.g., a button), a lever, or the like (with or without a mechanical advantage or disadvantage). While the foregoing actuators are described as rotatable, slidable, or translatable, and depressible elements, it should be understood that any suitable actuator may be utilized, and any of these actuators may be used to cause advancement and / or retraction of the elongate member and / or delivery of the fluid composition (e.g., the first actuator may be a slide, a button, a rotatable element, etc., and the second actuator may be a slide, a button, a rotatable element, etc.).

[0072] In some variations, the drive mechanism (320) may be configured to allow the delivery system to be used only once, i.e., the drive mechanism (320) may prevent re-advancement of the slidable elongate member (308) after, for example, a predetermined amount of extension and / or retraction. In other variations, the drive mechanism (320) may be configured to allow the elongate member (308) to be advanced, retracted, re-advanced, and re-retracted an unlimited amount and number of times. Exemplary mechanisms by which an external input may be translated into movement of one or more components of the delivery system are described in more detail herein.

[0073] In some variations, the drive assembly (320) may include components that convert rotary motion into linear motion. For example, the drive assembly (320) may include a linear gear and a pair of pinion gears. Each of the pinion gears may also be coupled to a rotatable component (350) (e.g., a wheel). In some variations, such coupling may be achieved using a pin that may be threaded through central openings in the rotatable component and pinion gear, and a nut that secures the rotatable component and pinion gear such that rotation of the rotatable component rotates the pinion gear, and vice versa. In some variations, the wheel may be attached to the pinion gear by one of the following methods: 1) the wheel and pinion gear are molded as one piece using plastic injection molding techniques, 2) the wheel is slid onto the pinion gear and secured with an adhesive, or 3) the wheel is slid onto the pinion gear and mechanically secured with fasteners or a "press fit" that presses the wheel onto the pinion gear and friction holds the wheel securely. The wheel and pinion gear may be coaxial, rotate in the same direction, and at the same angular velocity. In some variations, the wheel may have markings or coloring to indicate the degree and / or direction of advancement.

[0074] One variation of the drive assembly (320) may include a linear gear, a pair of pinion gears, and at least one rotatable component coupled to each pinion gear. In other variations, the drive assembly may include a linear gear, a single pinion gear, and a single rotatable component coupled to the pinion gear. In variations with a pair of pinion gears, the pinion gears and associated wheels may be disposed on opposite sides of the linear gear. In some variations, the pinion gear and linear gear may contact each other, i.e., the teeth of the pinion gear may directly engage corresponding teeth on the linear gear, and the wheel on one side of the linear gear may contact the wheel on the opposite side of the linear gear. In other variations, the pinion gear and linear gear may be indirectly coupled, for example, via one or more idler gears.

[0075] At least a portion of the wheel (350) on the side of the linear gear may extend outside the housing (304) for user manipulation. The drive assembly (320) may be operated with one hand when in a first configuration and then operated with the same or other hand when flipped to a second configuration. A drive assembly (320) with such flexibility may be easily used by right- or left-handed individuals and may also be used in procedures where the handle is flipped during a procedure so that the cannula (306) faces a first direction during a first portion of the procedure and a second direction during a second portion of the procedure. In a further variation, the drive assembly (320) may include one rotatable component on one side of the handle (302) and the "universal" feature of the handle (302) provided by the cannula (306) being able to rotate itself instead of flipping the handle (302). When the wheel and pinion gear rotate in the same direction on the same axis, and when there are no idler gears or an even number (e.g., two) of idler gears between the pinion gear and the linear gear, distal rotation of the portion of the wheel extending from the housing may result in proximal translation of the linear gear within the housing (304), and conversely, proximal rotation of the portion of the wheel extending from the housing (304) may result in distal translation of the linear gear within the housing (304). When the wheel and pinion gear rotate in the same direction on the same axis, and when there are an odd number (e.g., one) of idler gears between the pinion gear and the linear gear within the housing, distal rotation of the portion of the wheel extending from the housing (304) may result in distal movement of the linear gear within the housing (304), and conversely, proximal rotation of the portion of the wheel extending from the housing (304) may result in proximal movement of the linear gear within the housing (304).

[0076] The drive assembly may also include one or more features to stabilize the pinion gears or otherwise keep them in place. For example, in some variations, the drive assembly may include wheel spacers configured to be located between the axes of the pinion gears.

[0077] In other variations, the rotary gears (i.e., pinion gears or idler gears) that interact with the linear gear may be capable of disengaging from the linear gear by biasing their position off-axis from the linear gear. This action disengages the rotary gear teeth from the linear gear teeth, preventing linear gear movement with wheel rotation. The drive assembly may also be capable of being locked to prevent rotation by engaging cross pins or features that prevent wheel rotation.

[0078] Further variations of the drive assembly may not employ conversion of rotational motion to linear motion. For example, a slide (e.g., a finger slide) on the handle may be fixedly or removably coupled to a gear (e.g., a linear gear as described above) within the housing of the handle. Here, the drive assembly may be configured such that advancement or retraction of the slide causes advancement or retraction of the elongated member and / or delivery of the fluid composition into Schlemm's Canal. In some variations, advancement or retraction of the slide may cause advancement or retraction of the elongated member, while delivery of the fluid composition into Schlemm's Canal may be actuated by a separate mechanism. In still further variations, a button that can be pressed or squeezed may be employed instead of a slide, or a foot pedal may be employed to deliver the fluid composition and advance and / or retract the elongated member. In some variations, advancement or retraction of the elongated member may be actuated by a separate mechanism, while pressing or squeezing a button may be employed to deliver the fluid composition into Schlemm's Canal.

[0079] Fluid Assembly Some variations of delivery device (300) may include a fluid assembly (330) comprising one or more of a fluid reservoir (332) in fluid communication with elongate member (308) and cannula (306), a seal member (336), and a connector (340), as shown in FIG. 3. The fluid assembly (330) may be at least partially contained within the housing (314) of the handle (304). For example, in some variations, the fluid reservoir (332) may be completely contained within the housing (314) of the handle (304), while in other variations, a portion of the fluid reservoir (332) may be contained within the housing (314) of the handle (304) and a portion may extend beyond or outside (e.g., proximally, laterally) the housing (314) of the handle (304).

[0080] connector The connector (340) may be configured to be releasably or detachably coupled to the fluid reservoir (330). A proximal region of the connector (340) may be configured to receive the end of an external fluid device to deliver a fluid composition to the fluid reservoir (332). Advantageously, the connector (340) may be detachable from the handle housing, simplifying and streamlining fluid delivery to the fluid reservoir (332). In some variations, the connector (340) may be configured to mate with the coupling hub (334) at a proximal region of the fluid reservoir (332). In some variations, the fluid assembly (330) may further include a sealing member (336) and a plug (338). In variations in which the connector is detachable, the sealing member (336) may be configured to seal the fluid reservoir (332). The plug (338) may be configured to direct the fluid composition from the connector (340) into the fluid reservoir (332), as described in more detail herein.

[0081] 4A illustrates a variation of a connector 400. As shown therein, the connector 400 may include a connector body 401 having a proximal portion 402 with a proximal lumen opening 404, a distal portion 403 having a distal lumen opening 406, and a connector lumen 408 located between and fluidly coupling the proximal and distal lumen openings 404 and 406. The connector 400 may further include one or more tabs 410 (e.g., two, three, four, or more) extending radially outward from the connector body 401 (e.g., the proximal and distal portions 402 and 403) and positioned between the proximal and distal portions 402 and 403. When the connector (400) includes two or more tabs (410), the first tab may extend in an opposite direction from the second tab, as shown in FIG. 4A . The one or more tabs (410) may be configured to be engaged by a user to grasp the connector (400) and easily disengage it from the handle housing for removal. In some variations, the proximal portion (402), and in particular the proximal lumen opening (404), may be configured to receive an end of an external fluid device therein to deliver a fluid composition through the connector (400) to the fluid reservoir. In other variations, the external fluid device may receive a portion of the connector, such as a portion of the proximal portion (402) (e.g., an external fluid delivery device may fit over the proximal portion (402) and / or the proximal lumen opening (404)). The distal lumen opening (406) may define a distal lumen wall (416) configured to engage a coupling hub in the proximal cavity of the handle. The distal lumen wall (416) of the connector (400) may be configured to engage the coupling hub in any suitable manner, such as, for example, utilizing threads, a press fit, a snap fit, a bayonet fit, an interference fit, or the like.

[0082] As shown in FIG. 4B, the distal lumen wall (416) may include one or more threads (412) configured to threadably engage corresponding threads on the coupling hub. The connector body (402) may include one or more extensions (414) configured to engage one or more abutments (654A / 654B) on the proximal end of the handle to prevent rotational movement of the connector (400) (see FIG. 6C) when the connector (400) is coupled to the proximal opening of the handle (see FIG. 6A). The one or more extensions (414) may extend from the distal portion (403) and may include a flat surface (415) and a curved surface (417). In some variations, the flat surface (415) may extend a maximum distance from the distal portion (403), while the curved surface (417) may taper a minimum distance from the distal portion (403). The flat surface (415) may physically contact one or more abutments (654A / 654B) when the connector (400) is rotated in a first direction. In variations containing two or more extensions (414), such as shown in FIG. 4B, the two or more extensions (414) may be oriented approximately 180 degrees apart. The one or more extensions (414) may properly orient the connector (400) within the proximal cavity of the handle by engaging the one or more extensions (414) with the threaded engagement portion (632) (see FIG. 6B). In some variations, the one or more extensions (414) engaging the one or more abutments (see FIG. 6C) may prevent a user from irreversibly securing the connector (400) to the connector hub of the handle (e.g., over-tightening, cross-thread engagement, etc.). In some variations, the connector body (402) may further include a collar (418). Collar (418) may be configured as a stop to prevent connector (400) from advancing too far into the proximal cavity of the handle. In other words, collar (418) may be configured to allow connector (400) to be inserted to an appropriate depth into the proximal cavity of the handle. If connector (400) is not inserted to an appropriate depth into the proximal cavity of the handle, proper fluid communication between the connector and the fluid reservoir may not occur, fluid may accumulate in the connector, and air may be introduced into the fluid assembly.When connector (400) is coupled to the coupling hub of the handle, connector lumen (408) may be aligned with the plug lumen (see FIG. 6C) to allow consistent and timely fluid flow from the proximal lumen opening (404) of connector (400) into the fluid reservoir. In some variations, connector (400) may be pre-coupled to the handle, while in other variations, connector (400) may be separated from the handle, allowing the user to couple connector (400) to the handle at their convenience.

[0083] handle The delivery systems described herein may include delivery devices with handles that allow for single-handed use by a single operator. The handles may be configured so that the ability to use the delivery system is independent of which hand the user chooses to use or which eye the procedure is being performed on. For example, the handles may be configured for use with either the left or right hand, and may be configured for use with either the left or right eye. The handles may further be configured so that the ability to use the delivery system is independent of the direction in which the tools and / or fluid composition are delivered around Schlemm's canal. For example, the delivery system may be used to deliver a fluid composition in a clockwise direction within the eye, and then, by a simple rotation of the handle (or, in another variation, by rotating the cannula itself 180 degrees), be used to deliver the fluid composition in a counterclockwise direction in a second orientation. However, it should be understood that in other variations, the delivery systems described herein may be configured to be used in a particular configuration (e.g., one side up, clockwise only, counterclockwise only, etc.).

[0084] Referring to FIG. 3 , the handle generally includes a housing having a proximal portion with a proximal end, a distal portion with a distal end, and a grip portion proximal to the distal end. The proximal portion generally may be configured to house or at least partially house components of a fluid assembly (e.g., a reservoir). The distal portion, more specifically, the grip portion, generally may be configured to be held by a user while positioning the cannula (e.g., advancing the cannula across the anterior chamber, perforating the trabecular meshwork, advancing the cannula into Schlemm's canal), while actuating the elongate member, and / or while delivering the fluid composition. The proximal and distal portions of the housing may each generally include an internal cavity that may house (or at least partially house) internal components of the device, such as components of the drive assembly and fluid assembly. The distal portion (e.g., the internal cavity of the distal portion) may house or at least partially house components of the drive assembly and may accommodate an internal portion of the cannula. It should be understood that one or more components of the drive assembly and / or fluid reservoir may be configured to translate and thus move between the internal cavities of the proximal and distal portions of the housing. In some variations, the distal portion (e.g., distal end) of the housing may include a fluid port that may be configured to provide fluid for irrigation of the surgical field and / or purge air from the system. The distal end of the housing may have a cannula coupled thereto. The gripping portion of the distal portion may be ridged, recessed, and / or grooved or otherwise textured in certain areas to improve a user's grip of the handle, increase the ergonomic fit of the handle in the user's hand, control the orientation of the handle without requiring wrist rotation, and / or improve user comfort. The gripping portion may be configured to allow a user to grasp the handle near or adjacent to the cannula (e.g., within about 3 inches or less) while still allowing the user to actuate the elongated member and / or deliver a fluid composition via one or more actuators.In some variations, the gripping portion may be configured to allow a user to grasp the handle within about 0.1 to 3 inches of the proximal end of the cannula. For example, the gripping portion may be configured to allow a user to grasp the handle within about 3 inches, about 2.5 inches, about 2 inches, about 1.5 inches, about 1 inch, about 0.75 inches, about 0.5 inches, or about 0.25 inches of the proximal end of the cannula. In some variations, the gripping portion may be configured to allow a user to grasp the handle within about 0.25 to 2 inches of the proximal end of the cannula. In some variations, the gripping portion may be configured to allow a user to grasp the handle within about 0.25 to 1.5 inches of the proximal end of the cannula. The proximal portion (e.g., the proximal end) may have a connector, such as connector (400) shown in FIGS. 4A and 4B, removably coupled thereto. The connector may be configured to releasably couple to an external fluid device to transfer a fluid composition from the external fluid device into the fluid reservoir.

[0085] The handle or portions thereof (e.g., gripping portion) may be made from or comprise any suitable material, including, but not limited to, fluoropolymer, polyetheretherketone, polyethylene, polyethylene terephthalate, polyurethane (or as a thermoset), thermoplastics such as nylon, or silicone. In some variations, the housing or portions thereof may be made from or comprise a transparent material. Suitable transparent materials are typically polymers such as acrylic copolymers, acrylonitrile butadiene styrene (ABS), polycarbonate (PC), polystyrene, polyvinyl chloride (PVC), polyethylene terephthalate glycol (PETG), and styrene acrylonitrile (SAN). Acrylic copolymers that may be particularly useful include, but are not limited to, polymethyl methacrylate (PMMA) copolymer and styrene methyl methacrylate (SMMA) copolymer (e.g., Zylar 631® acrylic copolymer). In variations where the general-purpose handle is reusable, the handle may be made from a material that can be sterilized (e.g., via autoclaving), such as a heat-resistant metal (e.g., stainless steel, aluminum, titanium) or a high-performance engineering polymer such as PEI, PEEK, or PEKK.

[0086] The length of a universal handle can generally be from about 1 inch (2.5 cm) to about 20 inches (50.8 cm). In some variations, the length of a universal handle can be from about 4 inches (10.2 cm) to 10 inches (25.4 cm) from the distal end of the handle to the proximal end of the handle. In some variations, the length of a universal handle can be about 4 inches, about 4.5 inches, about 5 inches, about 5.5 inches, about 6 inches, about 6.5 inches, or about 7 inches (17.8 cm) from the distal end of the handle to the proximal end of the handle.

[0087] The handle can be configured for ambidexterity and ergonomically fit the hand. To that end, one or more of the proximal and distal portions of the handle can be configured to be symmetrical across one or more planes (e.g., two planes), such as the YZ plane and the XZ plane. Such a configuration can make it easier for a user to rotate the handle around its longitudinal axis during use (e.g., about 10 degrees to about 180 degrees or more). In some variations, such a configuration can make it easier for a user to rotate the handle about 15 degrees to about 30 degrees, including about 20 degrees, around its longitudinal axis during use of the device (e.g., during delivery of a fluid composition to each hemisphere of Schlemm's canal). In some variations, all portions of the handle can be symmetrical across one or more planes (e.g., the YZ plane, the XZ plane, and the XY plane). In some variations, one or more of the distal and proximal portions may be configured to be symmetrical across one or more planes and may have a non-circular cross-sectional shape, while in other variations, one or more of the distal and proximal portions may be configured to be symmetrical across one or more planes and may have a circular cross-sectional shape. For example, in some variations, one or more portions may have a circular cross-sectional shape (e.g., the proximal portion, the distal end of the distal portion) and one or more portions may have a non-circular cross-sectional shape (e.g., the gripping portion of the distal portion). It should be understood that the symmetry of a portion of the housing may refer only to the shape of the exterior of that portion (e.g., the exterior surface) and may or may not include the interior surface of the housing (i.e., the exterior of a portion of the housing may be symmetrical across a plane, but the interior surface may include different pins, extensions, or other structures configured to interact or engage with internal components of the device).

[0088] Distal portion of the handle Referring to FIG. 2 , the handle (200) may include a housing (206) further comprising a proximal portion (202) and a distal portion (201). In some variations, the distal portion (201) may include a grip portion (204). The grip portion (204) may include a first curved side and a second curved side opposite the first curved side, as described in more detail herein. In some variations, the grip portion (204) may include one or more actuators (210), which may be configured to move the elongated member (234) and / or deliver fluid. The grip portion (204) may further include a tapered region configured to receive a user's finger. The tapered region may be distal to the one or more actuators (210) and / or the first and second curved sides. In some variations, the gripping portion (204) may be of the same length as the distal portion (201), while in other variations, the gripping portion (204) may be a segment or portion of the distal portion (201) such that the length of the gripping portion (204) is shorter than the length of the distal portion (201). For example, in some variations, the gripping portion and the distal portion may have the same proximal end, while the distal end of the gripping portion may be proximal to the distal end of the distal portion. For example, in some variations, the distal end of the handle may not be part of the gripping portion.

[0089] In some variations, the grip portion (204) may further comprise one or more flat regions (240) (e.g., two, three, four, or more). The flat regions (204) may be configured to receive a portion of a user's hand during a procedure (e.g., configured as a finger rest). In some variations, the one or more flat regions (240) may be proximal to the one or more actuators (210). The one or more flat regions (240) may comprise a planar surface configured to provide a surface on which a user may rest a portion of the user's hand. In some variations, the grip portion (204) may include a first flat region comprising a first planar surface and a second flat region comprising a second planar surface, as described in more detail herein. The one or more flat regions may have any suitable size and shape. For example, in some variations, each of the one or more flat regions may be positioned across a majority of the width of the top or bottom surface of the handle housing, such that a majority of the top or bottom surface is planar. In some variations, one or more flat regions may be positioned across about 50% to about 100% of the width of the top or bottom surface. For example, in some variations, one or more flat regions may be positioned across at least about 50%, at least about 60%, at least about 70%, at least about 75%, at least about 80%, at least about 85%, at least about 90%, at least about 95%, or about 100% of the width of the top or bottom surface. In some variations, one or more flat regions may have a maximum width that is about 50% to about 100% of the center width of the handle at a location aligned with the maximum width of the flat region. Each one of the one or more flat regions may have a maximum width that is at least about 50%, at least about 60%, at least about 70%, at least about 75%, at least about 80%, at least about 85%, at least about 90%, at least about 95%, or about 100% of the center width of the handle at a location aligned with the maximum width of the flat region.

[0090] In general, the gripping portion can be equal to or less than the overall length of the distal portion. For example, in some variations, the ratio of the length of the gripping portion to the length of the distal portion can be 1:1, 1:1.25, 1:1.5, 1:1.75, 1:2, 1:2.25, 1:2.5, 1:2.75, 1:3, 1:3.25, 1:3.5, 1:3.75, or 1:4.

[0091] In some variations, the grip portion (204) may include a non-slip material. The non-slip material may extend beyond one or more actuators and terminate adjacent the distal end of the handle. In some variations, the grip portion (204) may include a non-slip material on a tapered portion. For example, the non-slip material may surround a portion (e.g., most of) or all of the tapered portion. The non-slip material may circumferentially surround all or a portion of the tapered portion.

[0092] Generally, the proximal and distal portions can each have a length along the longitudinal axis, and the overall length of the handle can be the sum of the lengths of the proximal and distal portions. In some variations, the proximal portion can have a length equal to the length of the distal portion, while in other variations, the length of the proximal portion can be greater or less than the length of the distal portion. For example, in some variations, the ratio of the length of the proximal portion to the length of the distal portion can be 1:1, 3:4, 2.5:4.5, 2:5, 1.5:5.5, 1:6, 0.5:6.5, 4:3, 4.5:2.5, 5:2, 5.5:1.5, 6:1, or 6.5:0.5. In some variations, the ratio of the length of the proximal portion to the overall length of the handle can be 1:2, 3:7, 2.5:7, 2:7, 1.5:7, 1:7, 4:7, 4.5:7, or 5:7. In some variations, the ratio of the length of the distal portion to the overall length of the handle may be 1:2, 3:7, 2.5:7, 2:7, 1.5:7, 1:7, 4:7, 4.5:7, 5:7.

[0093] In some variations, the proximal portion may have a length within the range of about 2 inches to about 7 inches, and / or the distal portion may have a length within the range of about 2 inches to about 7 inches, including all values ​​and subranges therein. For example, the proximal portion may have a length within the range of about 3 inches to about 6 inches, including about 4 inches to about 5 inches. The distal portion may have a length within the range of about 3 inches to about 6 inches, including about 4 inches to about 5 inches.

[0094] Along the length of the handle, the proximal portion may have a first diameter and the distal portion may have a second diameter different from the first diameter. In some variations, the first diameter and the second diameter may be equal. The first diameter and the second diameter may each be constant, or at least one of the first diameter and the second diameter (including both diameters) may vary along the length of the handle. In some cases, the first diameter (e.g., the largest diameter) of the proximal portion may be larger than the second diameter (e.g., the largest diameter) of the distal portion, or the second diameter (e.g., the diameter at the proximal end of the distal portion) may be larger than the diameter of the proximal portion (e.g., the diameter at the proximal end of the proximal portion).

[0095] 5A shows a delivery device (500) including a handle (502) comprising a housing (504) with a distal portion (505) and a proximal portion (503). The distal portion (505) of the housing (504) of the handle (502) may include a gripping portion (506) configured to be received in a user's hand or otherwise grasped or held during use of the device, more specifically, during advancement of the device into Schlemm's canal, accessing Schlemm's canal with the cannula, actuating the elongated member, and / or delivering the fluid composition. While a user may grasp the handle (502) anywhere, including during transfer of the fluid composition into the fluid reservoir, the gripping portion (506) may be configured to receive the user's hand (e.g., finger) and provide convenient access to one or more actuators during the procedure, particularly during accessing Schlemm's canal and / or during delivery of the fluid composition to the eye. The gripping portion (506) may be coextensive with the distal portion of the handle (502) or may form a portion or segment of the distal portion. In some variations, the gripping portion (506) may be configured to allow the user to position their hand forward relative to the patient, while the proximal portion (503) may rest in the groove between the user's thumb and index finger. Generally, the handle is designed to allow the user to firmly grasp the gripping portion near the cannula, which includes one or more actuators distally. In some variations, the gripping portion (506) may taper toward the cannula, thereby forming an elongated nose, which may further enable precise control of the distal portion by providing a surface that allows for easy and comfortable placement of the user's fingers. Additionally, the gripping portion (506) is configured to facilitate the user's gripping and manipulation of the device near the cannula, which may optimize the user's control of the cannula during use (e.g., while accessing Schlemm's canal). The location and shape of the gripping portion (506) also allows the user's hand to be closer to the patient, which can improve stability and control of the device.Additionally, the handle, and particularly the gripping portion (506) of the handle, may be configured to provide contact points for manipulation and control, as described above, while also allowing the user to access one or more actuators of the device without repositioning their hands.

[0096] As described above, generally, the handle can be configured so that a user can grasp the handle by a gripping portion and still easily access one or more actuators that can be used to actuate the elongate member and / or deliver the fluid composition to Schlemm's canal. As shown in Figure 5A, the one or more actuators can include two actuators (550A / 550B), i.e., an upper first actuator (550A) and a lower second actuator (550B).

[0097] In some variations, the device may be configured so that a user can grasp the handle at the gripping portion (506) to deliver the fluid composition in a clockwise direction at the eye, and then, by simply rotating the handle (502) (or in another variation, by rotating the cannula itself 180 degrees), the device can deliver the fluid composition in a counterclockwise direction at the eye. In some variations, as described above, the gripping portion (506) may include one or more flat regions proximal to the one or more actuators (550A / 550B). Each of the one or more flat regions may include a planar surface, as seen in FIG. 5A . In some variations, the gripping portion (506) may further include a first planar surface at the top of the handle (as seen in FIG. 5A ), including the first flat region (542A). The gripping portion (506) may further include a second flat region (542B), further including a second flat surface at the top of the handle. In some variations in which the gripping portion comprises a first flat region and a second flat region, the first flat region and the second flat region may have corresponding sizes and / or shapes and / or may be symmetrical to each other across the central longitudinal axis of the handle.

[0098] The grip portion (506) of the handle can be configured to be non-slip and / or at least partially compressible relative to the remainder of the handle. For example, the grip portion (506) can have properties that make it easier to hold relative to the remainder of the handle, such as by comprising a material having a higher coefficient of friction and / or a lower durometer than the remainder of the handle housing (e.g., proximal portion, proximal end of distal portion). The grip portion (506) can comprise multiple materials, including, for example, a material having the above-mentioned properties that is overlaid on or otherwise covering the material from which the remainder of the housing is formed. For example, in some variations, the housing can be formed from a first material, such as ABS or PC, and the grip portion can further comprise a second material, such as an elastomer (e.g., rubber), bonded to the first material (e.g., to its exterior surface). In some variations, proximal portion (503) may be formed from a first material, distal portion (505) may be formed from a second material different from the first material, and gripping portion (506) may be formed from a third material different from the first and second materials. In some variations, increased friction between gripping portion (506) and the user's hand due to the gripping portion material having a higher coefficient of friction compared to other materials of the handle allows the user to maintain control and / or orientation of the device without it slipping out of the user's hand.

[0099] In some variations, the gripping portion (506) or a portion thereof may include a textured surface (508) configured to aid a user in maintaining contact and manipulating the handle (502). The textured surface (508) may be overlaid on the gripping portion (506) and may be constructed of a different material than the gripping portion (506). In some variations, the textured surface (508) may extend from the distal end of the distal portion to the proximal portion. The textured surface (508) may include raised elements (e.g., protrusions) and / or recessed elements (e.g., indentations, imprints, engravings, etc.), or a combination thereof. For example, the raised elements may include bumps and / or the recessed elements may include circular indentations. Each of the raised or recessed elements may be the same size or different sizes (e.g., cross-sectional area, diameter, etc.). Each of the raised or recessed elements may be the same shape (e.g., triangular, circular, oval, square, rectangular, hexagonal, octagonal, etc.) or may be different shapes. The textured surface (508) may have a consistent pattern across the gripping portion (506) or may have a varying pattern configured to enhance the tactile feel of the textured surface (508) in the hand. For example, in some embodiments, the textured surface (508) may have protrusions of a first height closer to one or more actuators (550) to aid a user in rotating the gripping portion (506), while the textured surface (508) may have protrusions of a second, different height further away from the one or more actuators (550). In some variations, the first height may be greater than the second height, while in other variations, the second height may be greater than the first height. In another embodiment, the textured surface (508) may have depressions of the same shape with larger cross-sectional areas closer to the one or more actuators (550) to increase tactile sensation closer to the one or more actuators (550), while depressions further away from the one or more actuators (550) have smaller cross-sectional areas.

[0100] Each of the top surface (510) and the bottom surface (513) may include features that assist a user in identifying the location of one or more actuators of the device through touch (e.g., without visual identification). For example, in some variations, the top surface (510) and / or the bottom surface (513) may include actuator boundaries (511, 513). The actuator boundaries (511, 513) may be composed of a different material than the gripping portion (506) or may be composed of the same material as the gripping portion (506). In some variations, the actuator boundaries (511, 513) may include recessed or raised elements, allowing a user to clearly identify the boundaries of the actuator boundaries (511, 513) and the actuators (550A, 550B) through touch. In some variations, one or more of the actuator boundaries (e.g., both) may be continuous with the planar surface of the corresponding flat region.

[0101] The grip portion (506) may be shaped to ergonomically fit a user's hand. To this end, in some variations, the grip portion (506) may be symmetrical across the YZ plane, as shown in FIG. 5B . The YZ plane may divide the grip portion (506) into a first grip portion or half (506A) and a second grip portion or half (506B) that are symmetrical across the YZ plane. The first and second grip portions (506A / 506B) may each include a rounded profile from a first top surface (510) to a second bottom surface (512) opposite the top surface (510). In this manner, the grip portion (506) may include a first curved side and a second curved side opposite the first curved side. More specifically, the first gripping portion (506A) may include a first curved side, and the second gripping portion (506B) may include a second curved side. In some variations, the first and second gripping portions (e.g., the first and second curved sides) may be symmetrical across the cannula. In some variations, the first gripping portion (506A) and the second gripping portion (506B) may be symmetrical across the XZ plane. In some variations, a portion of each of the first curved side and the second curved side may be aligned with the first and second actuators (550A / 550B), respectively. For example, in some variations, the first and / or second actuators may be longitudinally centered along the first and / or second curved sides, respectively.

[0102] In some variations, the first gripping portion (506A) (e.g., the first curved side) and the second gripping portion (506B) (e.g., the second curved side) may each be convex or have a convex curve. In some variations, the convex curve of the first gripping portion (506A) and the second gripping portion (506B) may have a radius of curvature of about 0.3 inches to about 1.5 inches. In some variations, the radius of curvature of the convex curve of the first gripping portion (506A) and the second gripping portion (506B) may include ranges from about 3 / 8 inches to about 1.5 inches, about 1 / 2 inch to about 1.5 inches, about 3 / 4 inch to about 1.5 inches, about 1 inch to about 1.5 inches, and about 1.25 inches to about 1.5 inches. In some variations, the radius of curvature of the convex curve of the first gripping portion (506A) and the second gripping portion (506B) may include ranges of about 0.3 inches to about 1 inch, about 3 / 8 inch to about 3 / 4 inch, including about ½ inch. The radius of curvature of the convex curve of the first gripping portion (506A) and the second gripping portion (506B) may include ranges of about 0.3 inches to about 1.5 inches, about 0.3 inches to about 1.25 inches, about 0.3 inches to about 1.0 inch, about 0.3 inches to about ¾ inch, about 0.3 inches to about ½ inch, and about 0.3 inches to about 3 / 8 inch. In some variations, as seen in FIG. 5B , the first gripping portion (506A) may have a first arc (e.g., a convex arc) with a first center, and the second gripping portion (506B) may have a second arc (e.g., a convex arc) with a second center, where the first and second centers may be on opposite sides of the central longitudinal axis of the cannula and / or the central longitudinal axis of the handle. In some variations, utilizing convex first and second gripping portions (506A, 506B) may allow a user to reorient or slightly rotate the gripping portions between their thumb and one or more opposing fingers, rather than reorienting or rotating the entire handle using their wrist. This may provide an ergonomic benefit to the user and help reduce arm fatigue. Furthermore, slight rotational movement of the first gripping portion (506A) and the second gripping portion (506B) may translate into movement of the distal tip.For example, in some variations, the first grip portion (506A) and the second grip portion (506B) may allow for orientation limits of approximately + / - 30 degrees around the central longitudinal axis through the user's grip alone, without the need for the user to rotate at the wrist.

[0103] The first and second gripping portions (506A, 506B) (e.g., the first and second curved sides) may each have one or more radii of curvature between the top and bottom surfaces (510A, 512A). For example, the first and second gripping portions (506A, 506B) may each include a first, smaller radius of curvature near or adjacent the top surface (510A / 512A) and a second, larger radius of curvature between (e.g., intermediate) the top and bottom surfaces (510A / 512A), allowing the gripping portions (506) to ergonomically fit the user's hand and contact the user's hand at or along multiple points to improve control of the device. In some variations, one or more of the first and second gripping portions (506A / 506B) may each comprise a faceted surface (e.g., a polygon with two or more sides) from a first upper surface (510) to a second lower surface (512) opposite the upper surface (510). In some variations, the faceted surfaces may collectively comprise a curve having a radius of curvature within the range of radii of curvature described herein. One or more faceted surfaces of the first and second gripping portions (506A / 506B) may be configured to control the angle of rotation of the gripping portion in a user's hand. While described in the preceding two paragraphs with respect to the first and second gripping portions (506A, 506B), it should be understood that such features are also applicable to the first and second curved sides, which may, in some variations, form the first and second gripping portions, respectively.

[0104] 5B, each of the actuators 550A / 550B may be positioned on or otherwise extend from the top and / or bottom surfaces 510A, 512A of the gripping portion. The actuators 550A / 550B may extend a defined distance from the top and bottom surfaces 510A / 512A and / or may have distinct shapes such that the actuators 550A / 550B are easily distinguishable from each of the surfaces 510A / 512A themselves when a user is manipulating the gripping portion 506. The top and bottom surfaces 510A / 512A may be substantially flat or may have a large radius of curvature relative to other portions of the handle (e.g., gripping portion, neck, proximal portion), thus allowing a user to easily place their fingers on the top and bottom surfaces 510A / 512A and place their fingers near but not on the actuators 550A / 550B. Referring to FIG. 5C , the top surface may include a first flat region 544A and the bottom surface may include a second flat region 544B. A user may place one or more fingers on each of the first flat region 544A and / or second flat region 544B.

[0105] In designing the handle 502 to have enhanced ergonomic features, the gripping portion 506 may be symmetrical about an XZ plane parallel to the longitudinal midpoint 570, as shown in FIG. 5C. The symmetry of the gripping portion 506 about the XZ plane allows a user to grasp the top surface 510 in substantially the same orientation as the bottom surface 512. Furthermore, the symmetry of the gripping portion 506 allows a user to select their preference of whether to use either the first actuator 550A, the second actuator 550B, or both in actuating the elongate member and / or delivering the fluid composition.

[0106] When a user's thumb or finger is in contact with either the top surface (510) or first actuator (550A) or the bottom surface (512) or second actuator (550B) (e.g., including one or more flat regions (544A / 544B)), the textured surface (508) of the gripping portion (506) may contact multiple locations on the user's hand for stability of the delivery device (500) during delivery of the fluid composition to the eye.

[0107] The grip portion (506) may have an hourglass shape, as shown in FIG. 5C . The grip portion (506) may taper from the top surface (510A) to the distal end (542) of the grip portion (506). The grip portion (506) may have a maximum height (562A) at a location along the longitudinal axis with the first actuator (550A) and the second actuator (550B). The grip portion (506) may have a minimum height (564A) at the distal end (542). The tapering of the grip portion (506) from the maximum height (562A) to the minimum height (564A) may provide the grip portion (506) with a compact feel in the user's hand and allow the user to easily rotate the handle (502) about the longitudinal axis to rotate the cannula as needed. Aligning the actuators 550A / 550B with the portion of the gripping portion having the maximum height 562A may allow for maximum separation between the two actuators 550A / 550B, thus allowing a user to clearly distinguish between the two actuators 550A / 550B while still being able to control each actuator individually or simultaneously. In some variations, the maximum height 562A may be aligned with at least a portion of the actuators 550A / 550B. For example, in certain embodiments, the maximum height 562A may be aligned with the midpoint of each of the actuators 550A / 550B.

[0108] The height of the gripping portion (506) may vary (e.g., decrease) proximally from a maximum height (562A) at one or more actuators (550A / 550B) to a smaller height (566A) at a neck (540) positioned proximally of the one or more actuators (550A / 550B). In some variations, the rate of change from the maximum height (562A) at one or more actuators (550A / 550B) to the height (556A) at the neck (540) may be greater than the rate of change of the taper from the maximum height (562A) at one or more actuators (550A / 550B) to the minimum height (564A) at the distal end (542). In some variations, the maximum height (562A) may be between about 0.8 inches and about 2.0 inches in height. For example, in some variations, the maximum height (562A) can be about 0.8 inches, about 0.9 inches, about 1.0 inches, about 1.1 inches, about 1.2 inches, about 1.3 inches, about 1.4 inches, about 1.5 inches, about 1.6 inches, about 1.7 inches, about 1.8 inches, about 1.9 inches, or about 2.0 inches. In some variations, the height (566A) of the neck (540) can be about 0.2 inches to about 0.8 inches. For example, in some variations, the height (566A) of the neck (540) can be about 0.2 inches, about 0.3 inches, about 0.4 inches, about 0.5 inches, about 0.6 inches, about 0.7 inches, or about 0.8 inches. In some variations, the minimum height (564A) can be about 0.05 inches to about 0.4 inches. For example, in some variations, the minimum height (564A) may be about 0.05 inches, about 0.1 inches, about 0.15 inches, about 0.2 inches, about 0.25 inches, about 0.3 inches, about 0.35 inches, or about 0.4 inches. In some variations, the ratio of the maximum height (562A) to the neck height (566A) may be about 5:1, about 4.5:1, about 4:1, about 3.5:1, about 3:1, about 2.5:1, about 2:1, or about 1.5:1. In some variations, the ratio of the maximum height (562A) to the minimum height (564A) may be about 16:1, about 17:1, about 18:1, about 19:1, about 20:1, about 25:1, about 30:1, about 35:1, or about 40:1.In some variations, the ratio of neck height (566A) to minimum height (564A) can be about 1.5:1, about 2:1, about 2.5:1, about 3:1, about 3.5:1, about 4:1, about 4.5:1, about 5:1, about 5.5:1, about 6:1, about 6.5:1, about 7:1, about 7.5:1, about 8:1, about 8.5:1, about 9:1, about 9.5:1, or about 10:1.

[0109] In some variations, the bottom of the gripping portion (506) may include a first curved surface (580B), a straight surface (584B), and a second curved surface (582B) therebetween. The first curved surface (580B) may be proximal to the second curved surface (582B), and the first curved surface (580B) may be concave, while the second curved surface (582B) may be convex. The second curved surface (582B) may include the actuator (550B). It may be understood that, with the gripping portion (506) being symmetrical across the XZ plane, the top surface (510) may include corresponding curved and straight surfaces. A straight surface (584B) may be distal to the second curved surface (582B), and the straight surface (584B) may taper along the longitudinal axis to the distal end (542).

[0110] In some variations, the grip portion (506) may have different cross-sectional shapes along the longitudinal axis of the handle. For example, proximally, the grip portion (506) may have a circular cross-sectional shape with a first diameter, a central portion of the grip portion (506) including the top and bottom surfaces (510A / 512A) and the actuators (550A / 550B) may have an oval or elliptical cross-sectional shape with major and minor axes, and a distal portion (including the distal end) of the grip portion (506) may have a circular cross-sectional shape with a second diameter. The major and minor axes may increase distally from the proximal portion of the grip portion (506) with a circular cross-sectional shape to maximum major and minor axes that may be aligned with the location of the actuators (550A / 550B), and then decrease distally to the distal portion of the grip portion (506) with a circular cross-sectional shape with the second diameter. In some variations, the first diameter may be larger than the second diameter, and the maximum major axis may be larger than both the first diameter and the second diameter. In some variations, the major axis may be at least about 1.5 times to at least about 3 times the minor axis. In some variations, the major axis may be at least about 1.5 times to at least about 2.5 times the diameter of the proximal portion of the handle. The first diameter of the gripping portion may be substantially equal to the diameter of the proximal portion of the handle. In some variations, the diameter of the proximal portion of the handle may be larger than the first diameter of the gripping portion. In some variations, the difference in diameter of different cross-sectional shapes along the longitudinal axis of the handle may provide additional benefits. For example, in some variations, a smaller diameter handle may allow for more degrees of rotation per movement, particularly at the distal end.

[0111] As described above, in some variations, the grip portion may have different cross-sectional shapes along the longitudinal axis of the handle. In some variations, one or more of the cross-sectional shapes may include a polygonal shape. For example, proximally, the grip portion (506) may have a circular cross-sectional shape having a first diameter, a central portion of the grip portion (506) may have a polygonal shape with facets (e.g., two or more faces), and a distal end of the grip portion (506) may have a circular cross-sectional shape. Polygonal shapes may include triangular prisms, quadrangular prisms, pentagonal prisms, hexagonal prisms, heptagonal prisms, octagonal prisms, etc. In some variations, the facets may collectively have a radius of curvature. In some variations, the cross-sectional shape of the handle housing at one or more flat regions may differ from the cross-sectional shape at any of the distal end of the distal portion, the neck, or the proximal portion.

[0112] The shape of the handle, the difference in diameter of portions of the handle along the longitudinal axis, and the taper of the gripping portion can help strike a functional balance between the deliberate movement required to rotate the distal end of the device and the precise control over subtle movements required during use.

[0113] Moreover, the handles described herein may be configured to promote or otherwise facilitate a forward grip (i.e., more distal on the handle), which may provide the user with additional control over the cannula. For example, the gripping portion of the handle may include a taper (e.g., an elongated nose), as shown in FIG. 5C. As shown there, the gripping portion (506) may comprise a taper from a maximum height (562A) of the gripping portion (506) to a minimum height (564A). The tapering of the distal portion may promote a forward grip of the handle (i.e., grasping the distal portion on the handle) by the user. Advantageously, a user's grip located more distally on the handle positions the user's hand closer to the patient's eye, allowing the user to have more control over the cannula. Furthermore, the taper from each of the top and bottom surfaces 510A / 512A to the distal end 542 provides a location (e.g., the gripping portion 506) for a user to position their index finger distal to the actuators 550A / 550B. The user can seamlessly move their index finger or thumb between the gripping portion 506 and the actuators 550A / 550B to access Schlemm's Canal (e.g., advance the device into Schlemm's Canal, perforate the trabecular meshwork, advance the distal tip of the cannula into Schlemm's Canal), actuate the elongate member, and / or deliver a fluid composition. Additionally, the taper from the maximum height 562A to the minimum height 564A of the gripping portion 506 provides multiple rest points for the user's fingers, which may further help reduce user fatigue.

[0114] Proximal end of handle FIG. 6A shows a perspective view of a delivery device (600) including a handle (602) having a distal portion (605) and a proximal portion (603) having a proximal end (607). The proximal portion (603) of the handle may have a circular cross-sectional shape having a diameter. In some variations, the proximal portion (603) of the handle (602) may have a constant diameter along the longitudinal axis, or the diameter may vary along the longitudinal axis (e.g., the diameter may taper to a smaller diameter at the proximal end (607)). In some variations, the proximal portion (603) may have an oval or oval cross-sectional shape with a major axis and a minor axis. The proximal end (607) may include a connector (620) configured to couple to (e.g., receive) an external delivery device to transfer a fluid composition to a reservoir of the delivery device (600). The connector (620) can be configured to seamlessly facilitate the transfer of a fluid composition from outside the delivery device (600) to the fluid assembly (608) of the housing (604) of the handle (602) while purging any air contained within the fluid assembly. As shown in FIG. 6A , the housing (604) of the handle (602) of the delivery device (600) can include an opening (612) at its proximal end configured to at least partially receive the connector (620) therein. Advantageously, having the connector (620) removably couple to the fluid assembly (608) at the proximal opening (612) of the housing (604) allows a user to easily and quickly transfer a required amount of the fluid composition to the fluid reservoir of the delivery device. Additionally, or alternatively, in some variations, the delivery device can be configured to automatically seal the fluid in the fluid reservoir upon removal of the connector (620). Removal of the connector may allow the handle (602) to remain compact during use without the connector (620) extending from the housing (604). In some variations, the fluid reservoir may include one or more engagement portions to facilitate coupling of the connector to the handle. For example, the fluid reservoir may include a threaded engagement portion that allows the connector to couple thereto.In some variations, the fluid reservoir may include other engagements that allow the connector to couple to the fluid reservoir without requiring rotational movement. For example, the fluid reservoir may include a snap fit, a bayonet fit, an interference fit, etc.

[0115] The connector (620) may be configured to connect to the housing (602) via the proximal opening (612). The connector (620) may have a connector lumen (624) therethrough. The connector lumen (624) may be in fluid communication with the proximal lumen opening (622), terminating at one end in the proximal lumen opening (622) and at the other end in the distal lumen opening (626). When the connector (620) is coupled to the delivery device (600) at the opening (612), the connector lumen (624) may provide fluid communication between the proximal lumen opening (622) and the fluid reservoir (610). An external fluid device may be coupled to the connector (620), for example, a portion (e.g., a distal end) of the external fluid device may be disposed within the proximal lumen opening (622) to deliver a fluid composition to the fluid reservoir (610). Once the desired volume of fluid has been delivered from the external fluid device to the fluid reservoir (610), the connector (620), and in some variations, the connector (620) coupled to the external fluid device, can then be detached from the delivery device (600), allowing the user to deliver the fluid composition to the eye, as described in more detail herein.

[0116] It should be understood that the connector (620) may or may not be connected to the housing via several mechanisms. For example, the connector may be rotatably coupled to the housing or axially (non-rotatably) coupled to the housing. For example, in variations in which the connector axially couples to the housing, the connector may comprise a snap-fit ​​connector, a bayonet fit, and / or any other connector suitable for use in an axial connection. FIG. 6B shows a perspective view of the proximal opening (612) of the housing (604). As described above, the proximal opening (612) may be configured to releasably couple the connector to the housing (604) of the handle (602). The handle (602) may include a proximal cavity (634), which may be at least partially defined by the proximal opening (612). The proximal cavity (634) may receive a connector therein. In some variations, the housing (604) may include a coupling hub (614) having a plug (616) positioned therein. The coupling hub (614) may extend proximally into the proximal cavity (634). The plug (616) may have any suitable cross-sectional shape, such as hexagonal, circular, square, oval, etc. The plug (616) may have a plug lumen (618) that may be in fluid communication with the fluid reservoir (610). The plug (616) and the plug lumen (618) may be configured to direct a fluid composition transferred through the connector to the fluid reservoir. In some variations, the plug (616) retains the valve by capturing the seal member (650) within the proximal bore of the fluid reservoir (610).

[0117] As shown in FIG. 6B, the coupling hub (614) can be configured to threadably engage the connector (see FIG. 6A). In some variations, the coupling hub (614) can include a coupling portion (630) configured to mate with a corresponding portion of the connector. The coupling portion (630) can include a mechanical coupling, such as, for example, threads. In other variations, the coupling portion (630) can include other mechanical coupling features (e.g., a press fit, an interference fit, a snap fit, a magnetic fit, etc.). In some variations, the mechanical coupling (e.g., threads) can extend radially outward from the coupling hub (614) into the proximal cavity (634), as shown in FIG. 6B. In some variations, the housing (604) can include a threaded engagement (632) extending inward into the proximal cavity (634). In some variations, the threaded engagement (632) may be angled distally to allow the connector to be rotated distally into the proximal cavity (634). This threaded engagement (632) may be configured to facilitate rotational movement of the connector tabs, as described herein.

[0118] 6C shows a rear view of the handle (602) including the proximal opening (612) and the proximal cavity (634). The proximal cavity (634) may include additional components that enable the connector to transfer the fluid composition to the fluid reservoir (610). For example, a seal member (650) may be positioned within the proximal cavity (634) and configured to seal the fluid reservoir (610) distal to the coupling hub (614). The seal member (650) may include an O-ring constructed of any elastomeric material. In some variations, the seal member (650) may be configured to help guide the fluid composition into the fluid reservoir (610).

[0119] In some variations, the fluid reservoir (610) may include a valve distal to the seal member (650). The valve may be configured to ensure that the fluid composition is sealed within the fluid reservoir (610) when the connector is removed and that the fluid composition does not exit the fluid reservoir (610) proximally through the plug lumen (618). The valve may generally ensure that fluid flow occurs from the proximal end of the handle (602) (e.g., when the fluid composition is loaded into the fluid reservoir (610)) to the distal end of the handle (602) (e.g., when the fluid composition is delivered through the elongate member to Schlemm's canal), but not vice versa. In some variations, the valve may include a one-way valve. In some cases, the valve may be a ball valve, a check valve including a ball check valve, a single-piece duckbill, or similar simple valve, etc. In some variations, the valve may be constructed from a single silicone component.

[0120] In some variations, the wall of the proximal cavity (634) may include one or more abutments (654A / 654B) extending into the proximal cavity (634) configured to allow the connector to be secured to the handle. The one or more abutments (654A / 654B) may be located at the proximal end of the thread engagement portion (632). When the connector is engaged with the coupling hub (614), the one or more abutments (654A / 654B) may prevent further rotational movement of the connector in a first direction. Furthermore, when the connector (620) is disengaged from the connection hub (614) in a second direction opposite to the first direction, the connector (620) may contact one or more abutments (654A / 654B), preventing further rotational movement in the second direction and indicating to the user that the connector (620) is completely disengaged from the connection hub (614) and may be removed from the proximal opening (612) in the proximal direction.

[0121] Cannula Referring back to FIG. 2 , the cannula (208) of the delivery system (200) may generally be coupled to and extend from the distal end of the housing (206) of the handle (202). The cannula (208) may be configured to provide easy and minimally traumatic access to Schlemm's canal, such as during a minimally invasive abinterno procedure. In some variations, the cannula (208) may be fixedly attached to the distal end of the housing (206). In other variations, the cannula (208) may be rotatably attached to the distal end of the housing (206) (e.g., via a rotatable hub, etc.) to change the orientation of the tip of the cannula (208). In variations of the delivery system in which the handle (202) is reusable and the cannula (208) is disposable, the cannula (208) may be removably attached to the distal end of the housing (206).

[0122] Some variations of the cannula (208) may include multiple sections with different geometric configurations. For example, in some variations, the cannula (208) may include a proximal end, a straight section, and a curved section distal to the straight section, the curved section having proximal and distal ends and a radius of curvature. In other variations, the cannula may generally include a curved section, the curved section may include a first curved section and a second curved section. The second curved section may have a larger radius of curvature than the first curved section. However, it should be understood that in other variations, the cannula may be entirely straight (e.g., may include only a straight section and no curved section). The cannula may also include a distal tip and a lumen extending from the proximal end through the distal tip. The lumen of the cannula may be in fluid communication with components of a fluid assembly, as described above. In some variations, the distal tip may comprise one or more angled surfaces and may further include a sharp piercing tip, as described in more detail below.

[0123] The cannula may be made of any suitable material with sufficient rigidity and biocompatibility to allow it to be advanced through the anterior chamber into Schlemm's canal. For example, the cannula may be formed from a metal, such as stainless steel, titanium, aluminum, or an alloy thereof (e.g., a Nitinol metal alloy), a polymer, a ceramic, or a composite material. Exemplary polymers include, but are not limited to, polycarbonate, polyetheretherketone (PEEK), PEKK, PEI, polyimide, polyamide, polysulfone, or a fluoropolymer. In some cases, it may be advantageous to coat the cannula with a lubricious polymer to reduce friction between the ocular tissue and the cannula during treatment. Lubricious polymers include, but are not limited to, hydrophilic coatings (such as polysaccharides), hydrophobic coatings, polyvinyl alcohol, polyethylene glycol, polyvinylpyrrolidone, fluorinated polymers (including polytetrafluoroethylene, PTFE, or Teflon®), and polyethylene oxide. In variations in which the cannula is reusable, the cannula may be made from a material that can be sterilized (eg, via autoclaving), such as a heat-resistant metal (eg, stainless steel, aluminum, titanium).

[0124] The cannula may generally have an outer diameter sized to gain access to the lumen of Schlemm's canal while minimizing obstruction of the surgeon's view. Accordingly, the outer diameter may range from about 50 microns to about 1000 microns. In some variations, the outer diameter may range from about 150 microns to about 800 microns, about 200 microns to about 700 microns, about 300 microns to about 600 microns, or about 400 microns to about 500 microns. The cannula also has an inner diameter that may range from about 50 microns to about 400 microns, about 100 microns to about 350 microns, or about 150 microns to about 300 microns. The cannula may also be formed to have any suitable cross-sectional shape, e.g., circular, oval, triangular, square, rectangular, etc. In some variations, the cannula may have a tapered shape along its length.

[0125] The cannula of an exemplary delivery system is shown in more detail in FIG. 7. As shown therein, the cannula (700) may comprise a proximal end (702), a curved portion (704), a straight portion (714), and a distal tip (706). The straight portion may be proximal to the curved portion, or the curved portion may be proximal to the straight portion. In some variations, the curved portion (704) may have two or more different radii of curvature (R). The curved portion (704) may have a proximal section (708) having a first radius of curvature and a distal section (710) having a second radius of curvature. In some variations, the radius of curvature (R) of the cannula may comprise two or more different radii of curvature, including a compound curve or a reverse curve. A compound curve may have a first curved portion having a first radius of curvature that bends in a first direction and a second curved portion having a second radius of curvature that bends in the same direction as the first direction and different from the first radius of curvature. A preliminary curve may have a first curved portion having a first radius of curvature that bends in a first direction and a second curved portion having a second radius of curvature that bends in a different direction from the first direction and different from the first radius of curvature, as described in more detail herein.

[0126] The curved portion (704) may also have an inner radius (720) defined by a surface of the cannula (700) closest to the center of the radius of curvature (R), and an outer radius (722) defined by a surface of the cannula further away from the center. The configuration of the curved portion (704) and distal tip (706) may be useful or advantageous for enabling easy, atraumatic, and controlled access into Schlemm's canal. For example, the radius of curvature (R) may center the distal tip (706) along a longitudinal axis defined by a portion of the body (714) of the cannula (700), allowing movement of the proximal end (702) to be easily translated into movement of the distal tip (706), giving the user more control over the distal tip (706). The distal tip (706) may have a proximal edge (724), a distal edge (726), and one or more radii of curvature (C) therebetween.

[0127] Utilizing a cannula (700) with a straight portion (714), a proximal end (708) and a distal end (710), a curved portion (704) having a radius of curvature therebetween, and a distal tip (706) can be particularly useful for accessing the lumen of Schlemm's canal. The cannula (700), including the straight portion (714) and the curved portion (704), can have a length ranging from about 5 mm to about 50 mm, about 10 mm to about 30 mm, or about 14 mm to about 20 mm. In some variations, the cannula (700) can have a length of about 18 mm. The curved portion of the cannula can have a uniform cross-sectional shape or can vary in shape. In some variations, the cross-sectional size of the cannula can vary along the curved portion (e.g., the cannula can be tapered), and in some cases, the cross-sectional size can be smaller near the distal end to facilitate entry into Schlemm's canal. The radius of curvature of the curved portion may be adapted to facilitate tangential and precise, minimally traumatic entry into Schlemm's canal and may range from about 1 mm to about 10 mm, or from about 2 mm to about 5 mm. In one variation, the radius of curvature may be about 2.5. The cannula may also have a first angular range defined by an arc created by the inner radius (720) and the proximal edge (724). In some variations, the cannula may have a second angular range defined by an arc created by the outer radius (722) and the distal edge (726). The first or second angular range may be suitable for facilitating entry into Schlemm's canal and may range from about 70 degrees to about 170 degrees, or from about 100 degrees to about 150 degrees. In one embodiment, the first or second angular range may be from about 100 degrees to about 120 degrees, including about 110 degrees.

[0128] The distal tip of the cannula may be sized, shaped, and have an appropriate geometry to allow easy and minimally traumatic access to Schlemm's Canal. For example, the distal tip (706) may include a compound curve between the proximal edge (724) and the distal edge (726), which may facilitate sliding of the trabecular meshwork over the distal edge (726) and over the compound curve to provide an access point within the trabecular meshwork through which the elongate member may access Schlemm's Canal, as described in more detail herein. It may be understood that the access point may include an opening to or within Schlemm's Canal, including an opening in the trabecular meshwork.

[0129] In other variations, the cannula may include a straight portion positioned between the distal tip and the curved portion of the cannula. The length of the straight portion may range from about 0.5 mm to about 5 mm. In some variations, the length of the straight portion ranges from about 0.5 mm to about 3 mm, or from about 0.5 mm to about 1 mm. The length of the straight portion may also be a non-zero value less than about 0.5 mm, such as about 0.1 mm, about 0.2 mm, about 0.3 mm, or about 0.4 mm. In some variations in which the distal tip is positioned directly adjacent to (after) the curved portion of the cannula (i.e., the distal tip directly engages the radius of curvature), the cannula may lack a straight portion (the length of the straight portion is zero).

[0130] As generally described above, the cannula may include a proximal end, a curved portion, a straight portion, and a distal tip. The cannula may have an inner radius defined by the surface of the cannula closest to the radius of curvature and an outer radius defined by the surface of the cannula further from the radius of curvature. The curved portion may terminate at the distal tip at either the outer or inner radius. Different cannula variations may include different curved portion configurations. In some variations, the curved portion of the cannula may be configured to direct the trajectory of the elongate member as it extends or advances from the cannula. Figures 8A-8E show projections of cannula variations having different proximal ends and curved portions. Advantageously, different cannula variations may allow the user more control over the distal tip of the cannula, providing ease of use in positioning the cannula and seating the distal tip of the cannula within Schlemm's canal when delivering a fluid composition to the eye. For example, different variations of the cannulas described herein may allow a user to use the same access point location when treating both hemispheres of Schlemm's canal.

[0131] As shown in FIG. 8A , the cannula 800A can include a proximal end 810A, a straight portion 806A, and a curved portion 812A having one or more radii of curvature. The proximal end 810A can be substantially straight or can include a curve. The curved portion 812A can have a proximal section 814A and a distal section 816A with a compound curve therebetween. In some variations, the proximal section 814A and the distal section 816A can be contained within the compound curve, or each of the proximal section 814A and the distal section 816A can be substantially straight with a compound curve therebetween. The compound curve can include two or more curves bending in the same direction, each of the two or more curves having a different radius of curvature. The proximal section (814A) of the curved portion (812A) may have a first radius of curvature, and the distal section (816A) of the curved portion (812A) may have a second radius of curvature. In some variations, the second radius of curvature may be smaller than the first radius of curvature. In other words, the proximal portion (814A) of the curved portion (812A) may have a flatter curve, and the distal portion (816A) of the curved portion (812A) may have a sharper curve. In some variations, the distal section (816A) of the curved portion (812A) may direct the trajectory of the elongated member as it extends from the distal section (816A) of the curved portion (812A) of the cannula (800A).

[0132] 8B, in some variations, cannula (800B) may include a curved portion between proximal end (810B) and distal tip (822B), the curved portion including a reverse curve (e.g., a modified S-curve). The reverse curve may include two or more curves, at least one curved portion bending in a first direction with a first radius of curvature and at least one curved portion bending in a second direction opposite the first direction and including a second radius of curvature different from the first radius of curvature.

[0133] As described above, the compound curve between the proximal section (814) and the distal section (816) may have two or more different radii of curvature. In the variation shown in FIG. 8C , the distal section (816C) of the curved portion (812C) may have a second radius of curvature that is greater than the first radius of curvature of the proximal section (812C), resulting in a proximal portion (814C) with a sharper curvature and a distal portion (816C) with a flatter curvature compared to the embodiment shown in FIG. 8A . In some variations, the distal section (816C) of the curved portion (812C), having a second radius of curvature that is greater than the first radius of curvature of the proximal section (814C), may orient the trajectory of the elongated member along the trajectory of the second radius of curvature of the distal section (816C) as the elongated member extends from the distal section (816C) of the curved portion (812C) of the cannula.

[0134] For example, in some variations, the compound curve may include a proximal section having a larger radius of curvature than the distal section, or the distal section may have a larger radius of curvature than the proximal section. In some variations, the ratio of the radius of curvature of the proximal section of the compound curve to the radius of curvature of the distal section of the compound curve may be about 10:1, about 9:1, about 8:1, about 7:1, about 6:1, about 5:1, about 4:1, about 3:1, or about 2:1. In some variations, the ratio of the radius of curvature of the distal section of the compound curve to the radius of curvature of the proximal section of the compound curve may be about 1:2, about 1:3, about 1:4, about 1:5, about 1:6, about 1:7, about 1:8, about 1:9, or about 1:10. For example, in a variation, the distal section may comprise a radius of curvature of about 0.10 inches and the proximal section may comprise a radius of curvature of about 1.00 inches. In some variations, the radius of curvature of the distal section can be from about 0.05 inches to about 0.5 inches, and the radius of curvature of the proximal section can be from about 0.5 inches to about 1.2 inches.

[0135] In each of these variations, the distal tip can be positioned on either the outer or inner radius. Figure 8D shows a variation of cannula (800D) having a curved portion (812D) with a proximal portion (814D) having a flatter curve and a distal section (816D) having a sharper curve. In this variation, the distal tip (822D) can be located on the inner radius (818D). Having the distal tip (822D) on the inner radius (818D) can change the orientation of the distal tip (822D) relative to the user and provide the user with additional flexibility when placing the distal tip (822D) in Schlemm's canal.

[0136] As shown in Figure 8E, the cannula (800E) may be curved and may include a proximal section (814E) and a distal section (816E) that may include a compound curve. The proximal section (814E) may be curved and may include a first radius of curvature, and the distal section (816E) may also be curved and may include a second, different radius of curvature. In this variation, the second radius of curvature may be larger than the first radius of curvature, and the first radius of curvature may be in the opposite direction compared to the second radius of curvature. The combination of the first and second radii of curvature, being in opposite directions and having different values, biases the distal tip (822E) of the cannula (800E) so that it may be positioned along the central axis (830E) of the proximal section of the cannula (e.g., in variations in which the proximal section or a portion thereof is straight), but the majority of the cannula (800E) may be offset from the central axis. In some variations, the central axis of the cannula (830E) may bisect the distal tip (822E) of the cannula. Advantageously, configuring the cannula 800 such that its distal tip 822E is positioned along the central axis 830E of the cannula's proximal section (e.g., in variations in which the proximal section or a portion thereof is straight) may improve positioning of the distal tip 822E relative to the handle, which may make it easier for a user to predict and understand the location of the distal tip 822E relative to the ocular anatomy during a procedure, even when the distal tip is not easily visually accessible. In other variations, including those in which the cannula's proximal section or a portion thereof is not straight, the cannula's distal tip 822E may be positioned along and / or bisect the central longitudinal axis of the handle. In some variations, the central longitudinal axis of the handle may be parallel to and / or substantially aligned with the central axis 830E of the cannula's proximal section. In some variations, a distal section (816E) with a second radius of curvature greater than the first radius of curvature may direct the trajectory of the elongate member as it extends from the cannula.

[0137] Cannula Distal Tip The distal tip of the cannula can be positioned within Schlemm's canal and used to help form an access point within the trabecular meshwork for entry of the elongated member into Schlemm's canal. When deployed in Schlemm's canal, the distal tip can help form an access point within the trabecular meshwork. The configuration of the distal tip can allow a user to create and use the same access point (e.g., an otomy) when delivering a fluid composition to both hemispheres of Schlemm's canal. The distal tip can be shaped into various variations described herein, and the distal tip configuration can facilitate entry into and seating within Schlemm's canal. The distal tip configurations disclosed herein can be configured to easily bias or support the distal tip against the scleral wall without perforating or puncturing the scleral wall. Shaping the distal tip can include using standard manufacturing procedures, including cutting, grinding, EDM, 3D printing, molding, etc. The distal tip can be shaped by forming a pattern on the distal end of the cannula. Each of the embodiments described below may include beneficial features that provide the advantage of easy and minimally traumatic access to Schlemm's canal to disrupt the trabecular meshwork and / or seat the distal tip within Schlemm's canal. FIG. 9A shows a perspective view of the distal tip (922) of the cannula (906). Generally, the distal tip (922) may include a distal edge (950), a proximal edge (940), and a lumen opening (930) of the cannula (906). The elongate member may exit the cannula through the lumen opening (930). The lumen opening (930) may comprise any suitable shape, including, but not limited to, a teardrop shape, an oval shape, a circle, a pentagon, a hexagon, an irregular shape, etc.

[0138] The proximal edge (940) may be straight or rounded. In some variations, the proximal edge (940) may comprise an inner proximal edge (942) and an outer proximal edge (944). The inner proximal edge (942) and the outer proximal edge (944) may define a base (982). The distal edge (950) may comprise an inner distal edge (952) and an outer distal edge (954). The inner distal edge (952) and the outer distal edge (950) may define a tongue (980). The tongue (980) may be used to disrupt the trabecular meshwork and may seat within Schlemm's canal during delivery of the fluid composition to the eye. Generally, the distal tip may have a length. For example, the distal tip (922) can have a length (972) from the proximal edge (940) to the distal edge (950). Generally, the tongue can have a length, and generally, the tongue length can include the distance along the longitudinal axis from the inner distal edge to the outer distal edge. The tongue length can comprise a percentage of the length of the distal tip. For example, the tongue length can include about 1% to about 50% of the length of the distal tip, including about 1% to about 5%, or about 5% to about 10%, or about 10% to about 15%, or about 15% to about 25%, including all values ​​and subranges therein. In some variations, the distal tip can have a diameter that tapers from the proximal edge to the distal edge, or the diameter of the distal tip can be constant from the proximal edge to the distal edge.

[0139] In some variations, the distal edge (950) may be rounded or straight. The distal edge (950) may be sharp and may be used to move and / or penetrate the trabecular meshwork. In some variations, one or more (including all) surfaces of the distal tip (922), including the distal edge (950), straight portion (960), proximal edge (940), curved portion (962), base (982), and tongue (980), may be substantially smooth (e.g., electropolished) to prevent damage to the elongate member. Generally, a cannula having an internal lumen may have a cannula wall having a wall thickness. For example, as shown in FIG. 9A , the cannula (906) may include a wall thickness (998) defined by an outer wall (994) of the cannula (906) and an inner wall (994) of the cannula (906). The wall thickness may be constant along the longitudinal axis of the cannula (e.g., from the proximal end to the distal tip), or the wall thickness may vary. For example, in some variations, the wall thickness (998) may be constant from the proximal end to the distal tip (922), or the wall thickness (998) may be constant along the length (972) of the distal tip (922). In other variations, the wall thickness (998) may vary, including at specific locations along the cannula. For example, the wall thickness (998) along the distal tip (922) may taper along the length (972), and the wall thickness (998) at the proximal edge (940) may be substantially greater (e.g., two times, three times, four times, etc.) than the wall thickness (998) at the distal edge (950). In some variations, the tapering of the wall thickness along the distal tip allows the distal tip to more easily penetrate the trabecular meshwork, creating an access point therein for deploying the elongate member. In some variations, the distal tip may include a side cut configured to narrow the diameter of the tongue, allowing the tongue to seat within Schlemm's canal.

[0140] Figure 9B shows a side perspective view of an embodiment of the distal tip (922) of Figure 9A. As described above, the cannula (906) can include an inner radius (918) defined by the surface of the cannula (906) closest to the radius of curvature and an outer radius (920) defined by the surface of the cannula (906) further away from the radius of curvature. Additionally, the distal tip (922) includes a distal edge (950) comprising a straight portion (960) of the distal tip, followed by a proximal edge (940) comprising a curved portion (962) of the distal tip. In some variations, the straight portion (960) may or may not be chamfered. The straight portion (960) of the distal tip can be distal to the curved portion (962) of the distal tip. The straight portion 960 and the outer radius 920 may form an angle 970, as shown in FIG. 9B. The angle 970 may generally be an acute angle and, in some variations, may be within a range of about 14 degrees to about 40 degrees, including all values ​​and subranges therein. For example, in some variations, the angle 970 may be about 14 degrees to about 20 degrees, about 22.5 degrees to about 28.5 degrees, about 18 degrees to about 26 degrees, or about 30 degrees to about 40 degrees. Utilizing an angle 970 of about 14 degrees to about 40 degrees may advantageously allow the distal tip 922 to be positioned tangent to Schlemm's canal when inserted therein, thereby allowing the elongated member to easily follow the trajectory of the cannula as it extends therefrom, for proper positioning of the elongated member in Schlemm's canal.

[0141] In some variations, the straight portion (960) of the distal tip may have one or more (e.g., two, three, four or more) straight segments. In variations in which the straight portion (960) of the distal tip has multiple segments, each segment may be substantially straight, but the segments may have different slopes. Similarly, in variations in which the curved portion (962) of the distal tip has multiple segments, each segment may have a different radius of curvature. In other words, in variations in which the curved portion (962) of the distal tip may have multiple segments, the curved portion may comprise a compound curve. It should be understood that the straight portion (960) of the distal tip and the curved portion (962) of the distal tip may each have any suitable number of segments, and any combination of straight portion (960) of the distal tip and curved portion (962) of the distal tip may be utilized. For example, in some variations, a straight portion of the distal tip having a single straight segment may be utilized with a curved portion of the distal tip comprising multiple curves with different radii of curvature, while in other variations, a straight portion of the distal tip with multiple straight sections with different slopes may be used with a curved portion of the distal tip with a single curve (the entire curved portion may have a single radius of curvature). Similarly, a straight portion of the distal tip having multiple straight segments with different slopes may be utilized with a curved portion of the distal tip having multiple curved segments.

[0142] Figure 9C shows a variation of a distal tip 922C of a cannula 906C similar to that shown in Figures 9A and 9B. In this variation, the distal tip 922C comprises a straight distal tip portion 960C and a curved distal tip portion 962C. The straight distal tip portion 960C and the outer radius 920C may form an angle 970C between about 18 degrees and about 26 degrees. When the angle 970C is between about 18 degrees and about 26 degrees, the curved distal tip portion 962C may have a shallower curve compared to the curved distal tip portion 962C of Figure 9B. Furthermore, this variation allows the trabecular meshwork to slide up the straight portion (960C) of the distal tip and at least partially up the curved portion (962C) of the distal tip, creating an access point for the elongated member to exit the lumen opening (930C) of the cannula (906) and enter Schlemm's canal.

[0143] In some variations, the distal tip may include a longitudinal midpoint configured to divide the cannula 1000 into two sections. Figure 10 illustrates another variation of a distal tip 1022. In this variation, the distal tip 1022 may include a longitudinal midpoint 1070 and a straight distal tip portion 1060 that may form a first angle 1084. The distal tip 1022 may further include a second angle 1086 formed between the longitudinal midpoint 1070 and the proximal edge 1040. The first angle 1084 may generally be within the range of about 14 degrees to about 35 degrees, including all values ​​and subranges therein. For example, the first angle 1084 may be within the range of about 27 degrees to about 35 degrees or about 14 degrees to about 22 degrees. The second angle (1086) is generally obtuse and may be in the range of about 90 degrees to about 160 degrees, including all values ​​and subranges therein. For example, in some variations, the second angle (1086) may be in the range of about 100 degrees to about 120 degrees.

[0144] The distal tips described herein generally have a length measured along the longitudinal axis of the device between the distal and proximal edges. For example, FIG. 10 shows a variation of a distal tip (1022) having a length (1072) measured along the longitudinal axis (1070) from the proximal edge (1040) to the distal edge (1050). The length of the distal tips described herein, in some variations, can be from about 0.013 mm to about 0.035 mm (including all values ​​and subranges therein). For example, the length can be from about 0.0145 mm to about 0.0185 mm, or from about 0.015 mm to about 0.019 mm, or from about 0.02 mm to about 0.03 mm. In some variations, one or more (including all) of the distal edge, proximal edge, straight portion, and curved portion of the distal tip described herein may have a chamfered edge, a smooth edge, or a combination thereof. In variations comprising both straight and curved portions, the length may include the corresponding lengths of the straight and / or curved portions, each measured similarly along the longitudinal axis. This can be seen in FIG. 10 , where length (1072) is the length of the distal tip, length (1061) is the length of straight portion (1060), and length (1063) is the length of curved portion (1062). In some variations, the straight and curved portions may comprise equal percentages of the length of the distal tip, or the length of the straight portion may comprise a greater percentage of the length of the distal tip than the length of the curved portion. For example, in some variations in which the length of the straight portion constitutes a greater percentage than the length of the curved portion, the length of the straight portion may be 51%, 55%, 60%, 65%, 70%, 75%, 80%, 85%, or 90% of the length of the distal tip. As another example, in some variations in which the length of the curved portion may constitute a greater percentage than the length of the straight portion, the length of the curved portion may be 51%, 55%, 60%, 65%, 70%, 75%, 80%, 85%, or 90% of the length of the distal tip. In some variations, the ratio of the length of the straight portion to the length of the curved portion may be approximately 1:1, 1.5:1, 1.75:1, 2:1, 2.5:1, 3:1, 1:1.5, 1:1.75, 1:2, 1:2.5, or 1:3.In variations including both straight and curved portions, the straight portions may have lengths in the range of about 0.066 mm to about 0.032 mm, and the curved portions may have lengths in the range of about 0.003 mm to about 0.063 mm. In other variations including both straight and curved portions, the curved portions may have lengths in the range of about 0.066 mm to about 0.032 mm, and the straight portions may have lengths in the range of about 0.003 mm to about 0.063 mm. As noted above, generally, the length of the straight portions may include the length of the tongue. In other words, the length of the tongue is a subset of the length of the straight portions. In some variations, length (1072) may include length (1061) of straight portion (1060), which includes the length of tongue (1080) and length (1063) of curved portion (1062). In some variations, the length of the tongue may be in the range of about 0.001 mm to about 0.02 mm. In some variations, the straight portion (1060) may include a side cut (1061) configured to allow the straight portion (1060) to be inserted into Schlemm's canal.

[0145] 11A-11L show views of different variations of the distal tip (1122). Each of the variations of the distal tip (1122A-1122L) can be combined with any of the disclosed embodiments of a cannula (as described above and shown in FIGS. 8A-8E) to form a cannula that can be used in a delivery system. Referring now to FIG. 11A, a distal tip (1122A) is shown having a length (1172A) comprising a straight portion (1160A) and a curved portion (1162A) of the distal tip. Within the defined length (1172A), a longer straight portion (1160A) ensures that the curved portion (1162A) comprises a sharper curve, while a shorter straight portion (1160A) ensures that the curved portion (1162A) can comprise a flatter curve. In some variations, when the straight portion (1160A) comprises a greater proportion of the length (1172A) compared to the curved portion (1162A), the distal tip (1122A) can be inserted deeper into Schlemm's canal. Each of the different variations of the distal tips (1122A-1122L) shown in Figures 11A-11L can be configured to allow the trabecular meshwork to slide up a portion of the straight portion of the distal tip and the curved portion of the distal tip to provide an access point through the trabecular meshwork through which the elongate member can access Schlemm's canal.

[0146] As shown in FIG. 11A , the curved portion (1162A) may comprise a compound curve, having two curves that bend in the same direction, each curve having a different radius of curvature. The angle (1170A) is the angle between the straight portion (1160) and the outer radius (1120A), and in some variations, may be in the range of about 14 degrees to about 20 degrees. In some variations, the distal tip (1122A) may taper from the proximal edge (1140A) to the distal edge (1150A). The distal edge (1150A) may be rounded or curved to allow the distal tip (1122A) to be positioned against the scleral wall or the anterior chamber during deployment without damaging or perforating the scleral wall or the anterior chamber.

[0147] In some variations, instead of tapering from the proximal edge to the distal edge, the distal tip may have a constant diameter. Additionally, or alternatively, in some variations, the distal edge (1150B) may be straight instead of rounded, as shown in FIG. 11B. The straight distal edge (1150B) may easily penetrate the trabecular meshwork. In some variations, the tongue (1180B) may further include a tongue channel (1190B) extending from the lumen opening (1130B) to the distal edge (1150B). The tongue channel (1190B) may facilitate sliding of the trabecular meshwork through the tongue (1180B) to the curved portion (1162B). The tongue channel (1190B) may facilitate sliding of the trabecular meshwork inward toward the lumen opening (1130B). Tongue channel (1190B) may also be configured to restrain and guide the elongate member out of lumen opening (1130B).

[0148] In some variations, the straight portion may have an elongated taper along its length, which may allow the tongue and straight portion to lie deeper within Schlemm's canal during deployment of the distal tip. For example, as shown in FIG. 11C , straight portion (1160C) includes an elongated taper along its length (1172C), which allows the tongue (1180C) and straight portion (1160C) to lie deeper within Schlemm's canal during deployment of the distal tip (1122C). The elongated taper of straight portion (1160C) may provide gradual lifting of the trabecular meshwork during deployment of the distal tip (1122C). In some variations, straight portion (1160C) may have chamfered, beveled, or rounded edges.

[0149] As shown in FIG. 11D, the straight portion 1160D may have a sharper taper along its length 1172D compared to the variation of the distal tip 1122C shown in FIG. 11C. The sharper taper of the straight portion 1160D may provide an overall shorter length 1172D of the distal tip 1122D, allowing the user to perform finer movements of the distal tip 1122D. Generally speaking, in some variations, the length of the distal tip may comprise equal portions of the length of the straight portion and the length of the curved portion. However, as noted above, in some variations, one of the length of the straight portion 1160D and the length of the curved portion 1162D may constitute a greater percentage (e.g., >50%) of the length of the distal tip 1172D. For example, in Figure 11C, the length of straight portion 1160C constitutes a greater percentage of distal tip length 1172C, while in Figure 11D, the length of curved portion 1162D constitutes a greater percentage of distal tip length 1172D. Further, in Figure 11A, the length of straight portion 1160A and the length of curved portion 1162A constitute equal percentages of distal tip length 1172A.

[0150] The lumen opening formed by and within the distal tip can have a variety of suitable shapes and sizes. For example, the lumen opening can be circular, semicircular, oval, semi-oval, etc., and can have a diameter or major axis of about 0.005 mm to about 0.02 mm. For example, FIG. 11E shows a variation of a distal tip (1122E) having an oval lumen opening (1130E). In some variations, the distal tip (1122E) can include a first straight portion (1160E1), a second straight portion (1160E2), a first curved portion (1162E1), and a second curved portion (1162E2). When forming the distal tip 1122E, the first straight portion 1160E1, the first curved portion 1162E1, and the second straight portion 1160E2, the second curved portion 1162E2 each have a shallow angle that intersects along the centerline of the distal tip 1122E. The first straight portion 1160E1, the second straight portion 1160E2 may be joined at a distal edge 1150E, which may be a point or may be rounded. The first curved portion 1162E1, the second curved portion 1162E2 may be joined at a proximal edge 1140E, which may be a point or may be rounded. The distal tip (1122F) can be configured to easily penetrate the trabecular meshwork and lift the trabecular meshwork over the distal tip of the cannula.

[0151] As described above, the straight portion of the distal tip may include a first straight portion and a second straight portion, with the first straight portion being distal to the second straight portion. Referring now to Figures 11F and 11G, a distal tip (1122F) is shown that includes a first straight portion (1160F1) and a second straight portion (1160F2). In this variation, seen in Figure 11G, the length (1172F) of the distal tip includes only the length of the first straight portion (1161F) and the length of the second straight portion (1163F). In other words, this variation has no curved portions. In this embodiment, as seen in Figure 11F, the distal tip (1122F) may include a channel (1190F). In some variations, as seen in FIG. 11F, the channel (1190F) may taper distally, while in other variations, the channel (1190F) may taper proximally or may have a constant width without tapering. The channel (1190F) may be configured to restrain and guide the elongated member along the direction of the channel (1190F) as the elongated member is actuated to exit the lumen opening (1130F). The first linear portion (1160F1) and the second linear portion (1160F2) may form a first angle (1198F). In some variations, the first angle (1198F) may be between about 90 degrees and about 150 degrees, including any value and subrange therein. The first straight portion (1160F1) may be configured to lift the trabecular meshwork as it slides up the first straight portion (1160F1), allowing the elongated member to easily enter Schlemm's canal. The first straight portion (1160F1) may also be inserted into Schlemm's canal. The second straight portion (1160F2) may be configured to restrain the elongated member as it exits the cannula at the cannula lumen opening. The slope of the first straight portion (1160F1) may have a smaller (i.e., flatter) slope than the second straight portion (1160F2). The configuration of the first and second straight portions (1160F1, 1160F2) may assist in forming a sufficiently large access point within the trabecular meshwork while restraining the elongated member as it moves through the access point and into Schlemm's canal.In some variations, constraining the elongate member includes maintaining a proper trajectory of the elongate member as it exits the cannula.

[0152] FIG. 11H shows another variation of the distal tip (1122G). In this variation, the distal tip (1122G) comprises a straight portion (1160G) with a chamfered edge and a curved portion (1162G), where the length (1162G) of the straight portion (1160G) may constitute a greater percentage of the length (1172G) of the distal tip than the length (1163G) of the curved portion (1162G), allowing the user to further position the distal tip (1122G) within Schlemm's canal. Additionally, the cannula may have a cannula wall thickness defined by the outer and inner walls of the cannula. For example, as shown in FIG. 11I, the cannula (1106G) may have a wall thickness (1192G) defined by the outer and inner walls (1194G and 1196G). The wall thickness can vary along the length of the distal tip, including tapering distally toward the distal edge. For example, the wall thickness can be in the range of about 0.01 mm to about 0.05 mm, or in the range of about 0.0010 inches to about 0.0050 inches. The wall thickness can be about 0.01 mm to about 0.04 mm, about 0.01 to about 0.03 mm, or about 0.01 mm to about 0.02 mm. The wall thickness can be about 0.01 mm to about 0.04 mm, about 0.02 mm to about 0.03 mm, or 0.02 mm to about 0.05 mm, about 0.03 mm to about 0.05 mm, or about 0.04 mm to about 0.05 mm. The wall thickness can be about 0.0010 inches to about 0.0040 inches, about 0.0010 inches to about 0.0030 inches, or about 0.0010 inches to about 0.0020 inches. The wall thickness can be about 0.0020 inches to about 0.0050 inches, about 0.003 inches to about 0.0050 inches, or about 0.0040 inches to about 0.0050 inches. In some variations, the wall thickness can be uniform along the distal length, can taper uniformly along the distal length, or can taper rapidly toward the distal edge. In some variations, the wall thickness (1192G) can remain constant along the length of the distal tip (1172G), as shown in FIG. 11H. A uniform wall thickness (1192G) along the length (1172G) of the distal tip can be configured so that the cross-sectional area of ​​the tongue (1180G) fits within Schlemm's canal.

[0153] As described above, the distal edge can be straight or rounded. For example, as shown in FIG. 11I, the distal edge (1150G) can have a rounded edge configured to be positioned against the scleral wall. The constant wall thickness (1192G) and the rounded configuration of the distal edge (1150G) can allow a user to confidently position the distal edge (1150G) against the scleral wall without perforating the scleral wall, minimizing the risk of damaging the scleral wall tissue, which would require significant perceptible force.

[0154] In some variations, the base of the distal tip may extend distally to a pointed edge. In some of these variations, both the base and the tongue may extend to an apex. In some variations, one or more of each of the apexes may be rounded, while in other variations, one or more of each of the apexes may not be rounded (e.g., may be angular). Referring now to FIGS. 11J-11L, the distal tip (1122H) may include a base (1182H) that extends to a base apex (1183H) and a tongue (1180H) that extends to a tongue apex (1181H). The base apex (1183H) may be offset proximally from the tongue apex (1181H), as shown in FIGS. 11J-11L. In other words, in some variations, the tongue can extend distally behind the base such that the base apex (1183H) is proximal to the tongue apex (1181H). In other variations, the base apex and tongue apex can be axially aligned such that the base apex and tongue apex are parallel to one another. In some variations, the base apex can have a larger radius of curvature compared to the tongue apex, resulting in a more rounded shape at the base apex, while in other variations, the tongue apex can have a larger radius of curvature compared to the base apex, resulting in a more rounded shape at the tongue apex. In other variations, the tongue apex and base apex can have the same radius of curvature, and the tongue apex and base apex have the same shape (see FIG. 11L).

[0155] Advantageously, in this variation, the tongue apex (1181H) and the base apex (1183H) can each simultaneously encounter the trabecular meshwork during deployment into the eye, providing an easily formed access point to Schlemm's canal. In some variations, the distal edge (1150H) can have a first straight portion (1160H1) followed by a first curved portion (1162H1), the first curved portion (1162H1) being positioned proximal to the first straight portion (1160H1) and including a compound curve. In some variations, the proximal edge (1140H) can include a straight portion and a curved portion. For example, the proximal edge (1140H) may include a second straight portion (1160H2) and a second curved portion (1162H2), where the second straight portion (1160H2) is distal to the second curved portion (1162H2), and the second curved portion (1162H) has a compound curve. In some variations, the curvature of the second curved portion (1162H2) may be opposite to the curvature of the first curved portion (1162H1). In this embodiment, the second curved portion (1162H2) may, together with the first curved portion (1162H1), form a continuous curve connecting the first straight portion (1160H1) and the second straight portion (1160H2). The distal tip length (1172H) can be measured from the proximal end (1195H) of the base (1182H) to the tongue apex (1181H). In this variation, the straight portions (1160H1 / 1160H2) constitute a greater proportion of the distal tip length (1172H) than the curved portions (1162H1 / 1162H2).

[0156] In some variations, the first and second straight portions and the first and second curved portions may each include a chamfered or beveled edge, as shown in FIG. 11K. During deployment, a user may easily position any one of the surfaces or edges, including the base apex (1183H), tongue apex (1181H), distal edge (1150H), or proximal edge (1140H), against the scleral wall without damaging tissue. Furthermore, a user may use the distal tip (1122H) in either a tongue apex (1182H)-up orientation, as shown in FIG. 11J, or a base apex (1182H)-up orientation, enhancing the versatility of the distal tip (1122H) during deployment.

[0157] How to use In some variations, methods for treating ocular conditions may include dilating Schlemm's canal and / or disrupting the trabecular meshwork using a single delivery system. In some cases, treating ocular conditions may result in increased aqueous drainage, decreased resistance to aqueous outflow, and / or decreased intraocular pressure. Some methods described herein may dilate Schlemm's canal, dilate the collecting canal, and / or disrupt any septa that may obstruct circumferential flow through Schlemm's canal. Dilating Schlemm's canal may disrupt the obstructed inner wall of the canal, stretch the trabecular meshwork, and / or increase the porosity of the trabecular meshwork. This may improve the natural aqueous outflow pathway. Dilatation may be achieved by delivery of a fluid composition (e.g., a viscoelastic fluid as described herein). Some methods described herein may include performing a trabeculotomy to sever the trabecular meshwork. Some methods described herein may include implanting an ocular device into Schlemm's canal. In some cases, the systems described herein may be used in performing abinterno trabeculotomy, abinterno transluminal trabeculotomy, clear corneal trabeculotomy, clear corneal transluminal trabeculotomy, abinterno tuberoplasty, and / or clear keratotuberculoplasty.

[0158] Loading the fluid composition into a delivery device Before the fluid composition is delivered to the eye, the fluid composition can be loaded into the delivery device from an external fluid device. It can be important to maintain the sterility of the fluid composition while rapidly transferring the fluid composition from the external fluid device to the fluid reservoir within the housing of the delivery device without introducing any additional air into the fluid assembly and while removing any existing air within the fluid assembly. In some variations, the delivery system can include an external fluid device configured to be coupled to a connector, which is removably coupled to the delivery device. The external fluid device can deliver fluid to the fluid reservoir within the delivery device through the connector. Having a connector removably coupled to the delivery device allows fluid to be transferred seamlessly and in a sterile manner from the external fluid device to the fluid reservoir. The fluid composition can quickly purge any air present in the fluid assembly as the fluid flows through the fluid assembly to the distal tip of the elongate member, which is in fluid communication with the fluid reservoir. Once the fluid composition has been transferred, the connector to which the external fluid device is coupled can be easily and quickly detached from the delivery device, allowing the delivery device to be placed on the eye. Figures 12A-12C show an exemplary method of delivering fluid from an external fluid device (1240) to a fluid reservoir (1210) of a delivery device (1200), the method including coupling the external fluid device to a handle of the delivery device using a connector of a fluid assembly of the delivery device, transferring a fluid composition into the fluid reservoir of the delivery device, and disconnecting both the connector and the external fluid device from the handle of the delivery device.

[0159] As shown in FIG. 12A , the delivery device (1200) includes a handle (1202) having a housing (1204) with a cannula (1206) coupled to the distal end of the housing (1204). The delivery device (1200) may further include a connector (1220) coupled to a proximal opening (1218) of the housing (1204). In some variations, the method may include filling an external fluid device (1240) with a volume of the fluid composition. The contents of the fluid composition may be as described above. The external fluid device (1240) may include a syringe, vial, or another container used to store a fluid.

[0160] In some variations, the method may further include removably coupling the external fluid device (1240) to the connector (1220). Once the external fluid device (1240) is coupled to the connector (1220), the method may further include transferring a volume of the fluid composition from the external fluid device (1240) to the fluid reservoir (1210). Transferring the volume of the fluid composition from the external fluid device (1240) to the fluid reservoir (1210) may include transferring a volume of fluid through the connector (1220) to the fluid reservoir (1210). Transfer of the fluid composition from the external fluid device (1240) to the fluid reservoir (1220) may be active or passive. The fluid reservoir (1220) may be sized to receive a defined volume of the fluid composition from the external fluid device (1240). In some variations, a volume of fluid composition in excess of the defined volume of the fluid reservoir 1210 can be transferred to the delivery device 1200, along with an additional volume of fluid composition used to prime the delivery device 1200 by removing any air within the fluid assembly and / or elongate member. The excess fluid can flow out the distal tip of the cannula 1206 or the elongate member, indicating to the user that the delivery device 1200 is primed with fluid and ready to deliver fluid to the eye.

[0161] The method of delivering fluid from the external fluid device to the fluid reservoir may further include detaching the external fluid device (1240) and the connector (1220) from the handle (1202), as shown in FIG. 12C. Removing the external fluid device (1240) and the connector (1220) may include removing the connector (210) while the connector (1220) remains coupled to the external fluid device (1240). Stated another way, removing the external fluid device (1240) and the connector (1220) may include removing the external fluid device (1240) and the connector (1220) together (e.g., simultaneously and while they remain coupled to each other). Removing the external fluid device (1240) and connector (1220) from the handle (1202) may include engaging a tab (1222) of the connector (1220) to disengage the connector (1220) from the handle (1202). In some variations, engaging the tab (1222) may include rotating the tab (1222) in a first direction. Additionally or alternatively, engaging the tab (1222) may include pulling the tab (1222) axially away from the handle housing. Removing the external fluid device (1240) and connector (1220) from the handle (1202) may include retracting or otherwise pulling the external fluid device (1240) and connector (1220) proximally from the handle (1202). In some variations, removing the external fluid device and connector from the handle may include depressing a release button on the handle and removing the connector from the handle.

[0162] The coupled connector (1220) and external fluid device (1240) can be detached from the delivery device (1200), as shown in FIG. 12C. Removing the connector (1220) and external fluid device (1240) together in a single step can advantageously simplify procedure setup. A user can engage the connector (1220), for example, using the tab (1222), and move the connector (1220) axially to further separate the connector (1220) (and the external fluid device (1240) coupled to the connector) from the delivery device (1200). In some variations, the connector (1220) and external fluid device (1240) can be disposed of, and the delivery device (1200) can be used to deliver a fluid composition to the eye, as described in more detail below. Although described above as a single removal step (e.g., removing the connector and external fluid device together), it should be understood that the two components may instead be released separately from the handle of the delivery device (e.g., the external fluid device may be disengaged from the connector, and then the connector may be disengaged from the housing of the handle).

[0163] Performing eye procedures FIG. 13 shows a flowchart of an exemplary method (1300) of treating an ocular condition, including delivering fluid to an eye. In some variations, the delivery device of the fluid delivery system may be contained in packaging, such as single-use packaging. In these variations, the method may include removing the delivery device from the packaging (1302). As described above, the delivery device may or may not be packaged with a connector coupled to a handle housing. In variations in which the delivery device is packaged with the connector separated, or in which the connector is otherwise separated upon preparation of the delivery device for use, the method may include coupling the connector to the handle at the proximal opening. In some variations, coupling the connector to the handle housing includes releasably coupling the connector to a coupling hub within a proximal cavity of the handle. In some variations, coupling the connector to the handle housing at the proximal opening includes inserting the connector into the proximal cavity of the handle and rotating or twisting the connector in a first direction.

[0164] The method (1300) may further include delivering fluid from an external fluid device through a connector to the fluid reservoir (1304). Delivering fluid from the external fluid device through the connector to the fluid reservoir may include delivering the fluid composition from the external fluid device through a connector releasably coupled to a fluid reservoir contained within a housing of a handle of the delivery device, the fluid reservoir being in fluid communication with an elongate member slidably positioned within a cannula coupled to the handle. Delivering fluid from the external fluid device through the connector to the fluid reservoir may include coupling the external fluid device to the connector to deliver the fluid composition from the external device to the fluid reservoir. In some variations, the external fluid device may be removably or releasably coupled to the connector, as described above. For example, in some variations, the external fluid device may be removably coupled to the connector with a threaded engagement. In some variations, delivering fluid from the external fluid device to the fluid reservoir may include delivering the fluid composition through the connector to the fluid reservoir until the fluid composition is received at the distal end of the cannula or until the fluid reservoir is filled and any residual air is purged from the cannula and elongate member.

[0165] In some variations, the method (1300) may further include detaching (1306) the connector and external fluid device from the delivery device. In some variations, detaching the connector and external fluid device from the delivery device may include detaching the connector and external fluid device while the external fluid device is coupled to the connector. In some variations, detaching the connector and external fluid device from the delivery device may include rotating the connector in a second direction opposite the first direction and / or axially retracting the connector and removing the connector from the proximal cavity of the handle. Removing the connector and external fluid device from the delivery device may include rotating the connector in the second direction opposite the first direction (e.g., using one or more tabs on the connector). In some variations, detaching the connector and external fluid device from the delivery device may include rotating the connector to release the connector and external fluid device from the handle.

[0166] In some variations, the method may generally include making an incision in the eye wall (e.g., the sclera or cornea) that provides access to the anterior chamber of the eye; advancing a cannula of a delivery system through the incision, at least partially across the anterior chamber, to the trabecular meshwork; and accessing Schlemm's canal with the cannula. The above-described method may also include priming or flushing the system with a fluid composition (e.g., to remove air from the system) and / or irrigating the surgical field to remove blood or otherwise improve visualization of the surgical field. The surgeon can first use a surgical microscope and a gonioscope or gonioprism to view the anterior chamber and trabecular meshwork (along with the underlying Schlemm's canal). Using a corneal, limbal, or scleral incision of 0.5 mm or greater, the surgeon can then gain access to the anterior chamber. Saline or a viscoelastic composition can then be introduced into the anterior chamber to prevent its collapse. Here, saline or the viscoelastic composition can be delivered through a delivery system cannula or by another method, such as injection through an irrigation sleeve on the cannula. Next, the surgeon can advance the delivery system cannula through the incision toward the anterior chamber angle while visualizing directly under a microscope. Once the angle (and thus the trabecular meshwork) is approached, the surgeon can apply a gonioscopic or gonioprism to the cornea to visualize the angle. Application of a viscous fluid (e.g., a viscoelastic composition as described above) to the cornea and / or the gonioprism can help achieve good optical contact and neutralize total internal reflection, thereby enabling visualization of the anterior chamber angle. Once the surgeon visualizes the trabecular meshwork, the cannula can be advanced so that its distal tip penetrates the trabecular meshwork and communicates with the lumen of Schlemm's canal.

[0167] The method (1300) may further include advancing (1308) a cannula into the anterior chamber of the eye and puncturing (1310) the trabecular meshwork with the distal tip of the cannula to enter Schlemm's canal. In some variations, puncturing the trabecular meshwork with the cannula tip may include puncturing the trabecular meshwork with the distal tip, including any of the variations described above, including FIGS. 11A-11L. In some variations, puncturing the trabecular meshwork with the distal tip may include lifting the trabecular meshwork with the distal edge and sliding the trabecular meshwork over a portion of the distal tip. Sliding the trabecular meshwork over a portion of the distal tip may create an access point in the trabecular meshwork through which the elongate member may be advanced. Puncturing the trabecular meshwork with the distal tip may include puncturing the trabecular meshwork with a distal tip having a distal edge including a straight portion, a curved portion having a compound curve with two or more curves that bend in the same direction, and a proximal edge. In some variations, puncturing the trabecular meshwork with the distal tip may include puncturing the trabecular meshwork with the distal tip, the distal tip comprising a straight portion and a curved portion comprising a reverse curve with two or more curves, at least one curve bending in a first direction and at least one curve bending in a second direction different from the first direction. In some variations, the distal tip may include a straight portion comprising a first straight portion distal to a second straight portion. In some variations, puncturing the trabecular meshwork with the distal tip may include sliding the trabecular meshwork over a portion of the straight and curved portions of the distal tip to provide an access point in the trabecular meshwork through which the elongated member can be advanced.

[0168] In some variations, the method may generally include a slidable elongate member coaxially disposed within a cannula lumen that is advanced into the canal under gonioscopic visualization. The method (1300) may further include advancing (1312) the elongate member around Schlemm's canal. The elongate member may be advanced any suitable amount and direction around the canal. For example, the elongate member may be advanced about 1 degree to about 360 degrees around the canal, about 10 degrees to about 360 degrees around the canal, about 150 degrees to about 210 degrees around the canal, or any suitable distance about 360 degrees around the canal, about 270 degrees around the canal, about 180 degrees around the canal, about 120 degrees around the canal, about 90 degrees around the canal, about 60 degrees around the canal, about 30 degrees around the canal, or about 5 degrees around the canal. In some variations, the elongate member may be advanced in two steps, for example, first in a clockwise direction (e.g., about 180 degrees, about 90 degrees, etc.) and second in a counterclockwise direction (e.g., about 180 degrees, about 90 degrees, etc.) around the canal (e.g., thereby achieving a 360 or 180 degree abinternoviscocanalostomy or canaloplasty). In some variations, the elongate member may be advanced in one step around the canal (e.g., about 90 degrees clockwise, about 180 degrees clockwise, about 270 degrees clockwise, about 360 degrees clockwise, about 90 degrees counterclockwise, about 180 degrees counterclockwise, about 270 degrees counterclockwise, about 360 degrees counterclockwise), thereby achieving the corresponding degree of abinternoviscocanalostomy or canaloplasty. Advancing the elongate member around Schlemm's Canal includes advancing the elongate member around Schlemm's Canal using a drive assembly. In some variations, advancing the elongate member around Schlemm's Canal using a drive assembly includes advancing or retracting the elongate member around Schlemm's Canal using one or more actuators, including one or more wheels, slides, or buttons as described herein.

[0169] The method (1300) further includes delivering (1314) a fluid (e.g., a fluid composition) to Schlemm's canal. The fluid composition may be injected upon advancement or retraction of the elongate member. Once the slidable elongate member is positioned within the canal, the fluid composition, e.g., a viscoelastic solution, may be delivered continuously or intermittently through the lumen of the elongate member. The fluid composition may exit the lumen of the elongate member through its distal end (e.g., through the distal tip), through openings or fenestrations provided along its shaft, or a combination of both. The openings or fenestrations may be spaced along the axial length of the elongate member in any suitable manner, e.g., symmetrically or asymmetrically along its length. If desired, other substances, such as drugs, air, or gas, may be delivered in the same manner. In some variations, retracting the elongate member may include using a first actuator to retract the elongate member and simultaneously deliver fluid to Schlemm's canal, while in other variations, retraction of the elongate member and delivery of fluid may be completely separate. Thus, in some variations, the method may include delivering fluid to Schlemm's canal and then retracting the elongated member, or vice versa. This combination of delivering fluid and retracting the elongated member (and / or advancing the elongated member) may be completed any suitable number of times during the procedure. It should be understood that the elongated member may be advanced and / or retracted any desired amount around Schlemm's canal to disrupt tissue and properly position the elongated member for fluid delivery. Any suitable number of actuators may be used to advance the elongated member, retract the elongated member, and deliver fluid, including using a single actuator for all, individual actuators for all, or a combination thereof. For example, in some variations, retracting the elongated member may include using a second, separate actuator to retract the elongated member and deliver fluid to Schlemm's canal.

[0170] In some methods, an elongate member having a lumen can be advanced into Schlemm's canal, and a fluid composition can be delivered via the elongate member. The elongate member and / or fluid delivery can dilate Schlemm's canal, and the fluid delivery can additionally dilate the collecting canal. The entire length of Schlemm's canal or a portion thereof can be dilated by the fluid. For example, at least 75%, at least 50%, at least 25%, at least 10%, or at least 1% of the canal can be dilated. The fluid composition can also be delivered to treat various ocular conditions, including, but not limited to, glaucoma, pre-glaucoma, anterior or posterior ocular vascular diseases, anterior or posterior ocular inflammatory diseases, ocular hypertension, uveitis, age-related macular degeneration, diabetic retinopathy, genetic eye disorders, complications of cataract surgery, vascular occlusion, vascular disease, or inflammatory disease.

[0171] In some variations, the slidable elongate member can be repositioned by retraction or repeated advancement and retraction. In some variations of the method, the same or a different incision can be used, but the cannula of the delivery system is employed to access and dilate Schlemm's canal from a different direction (e.g., counterclockwise instead of clockwise). Once a sufficient amount of fluid has been delivered, the surgeon can retract the slidable elongate member into the cannula and remove the delivery system from the eye. It should be understood that the cannulas described herein can be manufactured with a dual-surface configuration (i.e., sharp and smooth surfaces), particularly at the distal tip, which may allow the elongate member to be advanced, repositioned, and / or retracted without cutting it off on the distal tip of the cannula. It should also be understood that these steps can be used alone or in combination (one at a time) with cataract surgery.

[0172] More generally, in the methods described herein, exemplary volumes of viscoelastic fluid that can be delivered can range from about 1 μl to about 200 μl, or in some cases, from about 1 μl to about 100 μl. In some cases, the volume sufficient to provide disruptive force can range from about 1 μl to about 50 μl, from about 1 μl to about 30 μl, from about 2 μl to about 16 μl, from about 5 μl to about 25 μl, or from about 8 μl to about 21 μl. In one variation, a volume of about 4 μl is sufficient to disrupt Schlemm's canal and / or surrounding tissue. In other variations, the volume of viscoelastic fluid sufficient to disrupt trabecular meshwork canalicular tissue can be about 2 μl, about 3 μl, about 4 μl, about 5 μl, about 6 μl, about 7 μl, about 8 μl, about 9 μl, about 10 μl, about 11 μl, about 12 μl, about 13 μl, about 14 μl, about 15 μl, about 16 μl, about 17 μl, about 18 μl, about 19 μl, about 20 μl, about 21 μl, about 22 μl, about 23 μl, about 24 μl, about 25 μl, about 26 μl, about 27 μl, about 28 μl, about 29 μl, about 30 μl, about 35 μl, about 40 μl, about 45 μl, or about 50 μl. In other variations, the volume of viscoelastic fluid sufficient to disrupt trabecular meshwork canalicular tissue can be, for example, about 50 μl to about 100 μl, including about 55 μl, about 60 μl, about 65 μl, about 70 μl, about 75 μl, about 80 μl, about 85 μl, about 90 μl, about 95 μl, or about 100 μl.

[0173] The method (1300) may include removing (1316) the distal tip of the cannula from Schlemm's canal. Removing the distal tip of the cannula from Schlemm's canal may include removing the distal tip of the cannula from the anterior chamber of the eye and rotating the distal tip. In some variations in which fluid has not been delivered to the entirety of Schlemm's canal, the method (1300) may optionally include rotating (1318) the cannula 180 degrees and reinserting (1320) the distal tip into Schlemm's canal. In some variations, rotating the cannula 180 degrees includes rotating the handle 180 degrees to rotate the cannula 180 degrees. In some variations, rotating the cannula 180 degrees may include rotating the cannula itself 180 degrees independently of (e.g., without) rotating the handle.

[0174] The method (1300) may further include advancing (1322) the elongated member around Schlemm's canal and delivering (1324) fluid to Schlemm's canal. Advancing the elongated member around Schlemm's canal may include advancing the elongated member the remainder of the circumference of Schlemm's canal (e.g., including from about 0 degrees to about 360 degrees around Schlemm's canal). Advancing the elongated member around Schlemm's canal may include advancing the elongated member around Schlemm's canal using a drive assembly. As described above, using a drive assembly to advance the elongated member around Schlemm's canal may include using one or more mechanical actuators, including one or more wheels, slides, or buttons, to advance the elongated member around Schlemm's canal. Retracting the elongated member and delivering fluid to Schlemm's canal as described above may include delivering fluid to Schlemm's canal during advancement or retraction of the elongated member. Advancing or retracting the elongate member includes using the first mechanical actuator or a second, separate mechanical actuator to advance or retract the elongate member and deliver fluid to Schlemm's canal.

[0175] Some of the delivery systems described herein may be configured to limit the cumulative amount of advancement and / or retraction of the slidable elongate member. For example, as described above, the elongate member may be advanced and retracted a certain cumulative distance (e.g., about 39 mm to about 40 mm each, corresponding to the approximate circumference of Schlemm's canal, or about 78 mm to about 80 mm each, corresponding to about twice the circumference of Schlemm's canal, or any other suitable distance), after which the elongate member may no longer be advanced. This advancement and retraction may occur over multiple advancement-retraction cycles. For example, the elongate member may be advanced about 20 mm, then retracted about 20 mm, then advanced about 20 mm, then retracted about 20 mm. When the cumulative distance is limited to about 40 mm, after these two cycles of advancement and retraction, the elongate member may no longer be advanced. In other variations, the delivery system may not limit the cumulative amount of advancement and / or retraction of the elongate member.

[0176] In some variations of the Abinterno method, the fluid composition may be delivered simultaneously with retraction of the elongate member (i.e., the fluid composition may be delivered in a manner that allows retraction of a system component to advance fluid from the system cannula). It should be understood that the delivery system may be configured so that the fluid composition is delivered continuously, passively, automatically, or actively by the surgeon. The fluid composition may also be delivered to the tube independently of gear shaft movement using a pump or auxiliary plunger. In some variations, retraction of the elongate member may correspond to a fixed volume of fluid composition being delivered through the lumen of the elongate member. The fluid composition may be delivered through a distal opening of the lumen of the elongate member as the elongate member is retracted, thus allowing fluid to be delivered uniformly throughout the portion of the tube through which the elongate member has been advanced.

[0177] Fluid compositions that can be delivered by the systems described herein include, but are not limited to, saline and viscoelastic fluids. The viscoelastic fluid can include hyaluronic acid, chondroitin sulfate, cellulose, derivatives or mixtures thereof, or solutions thereof. In one variation, the viscoelastic fluid includes sodium hyaluronate. In another variation, the viscoelastic composition can further include a drug. For example, the viscoelastic composition can include a drug suitable for treating glaucoma, reducing or lowering intraocular pressure, reducing inflammation, fibrosis, angiogenesis, or scarring, and / or preventing infection. For example, in some variations, the viscoelastic composition can include a therapeutic agent described herein, such as, but not limited to, a Rho kinase (ROCK) inhibitor, and agents for gene therapy, DNA, RNA, or stem cell-based approaches.

[0178] The viscoelastic fluid may also include an agent to aid in visualization of the viscoelastic fluid. Examples include, but are not limited to, dyes such as fluorescein, trypan blue, or indocyanine green. In some variations, a fluorescent or bioluminescent compound is included in the viscoelastic composition to aid in its visualization. In other variations, the system may deliver only the drug without the viscoelastic composition. In this case, the drug may be loaded onto or into a sustained-release biodegradable polymer that elutes the drug over a period of weeks, months, or years. It is also contemplated that air or gas may be delivered using the systems described herein.

[0179] The viscoelastic fluid can be delivered while advancing the elongated member of the one-handed, single-operator-controlled device through Schlemm's canal in a clockwise direction, a counterclockwise direction, or both, or while withdrawing the elongated member from Schlemm's canal. As described above, the viscoelastic fluid can be delivered to disrupt Schlemm's canal and the surrounding trabecular canalicular tissue. For example, the delivered viscoelastic fluid can cause disruption by dilating Schlemm's canal, increasing the porosity of the trabecular meshwork, stretching the trabecular meshwork, forming microtears or perforations in the juxtacanalicular tissue, removing septa from Schlemm's canal, dilating the collecting canals, or a combination thereof. The elongated member can be loaded with the viscoelastic fluid at the beginning of the ocular procedure so that the fluid can be delivered by a single device. This is in contrast to other systems that use forceps or other advancement tools to advance a fluid delivery catheter into Schlemm's canal, and / or devices containing viscoelastic fluids that are separate or independent from the delivery catheter or catheter advancement tool and require connection to the delivery catheter or catheter advancement tool during the procedure by an assistant while the delivery catheter or catheter advancement tool is held by the surgeon.

[0180] Some of the methods described in more detail herein may include dilating Schlemm's canal and / or aqueous humor collecting canal (e.g., with a viscoelastic fluid) using a delivery system described herein. The methods may also include disrupting or severing the trabecular meshwork of Schlemm's canal. These methods may be performed separately or combined into a single procedure. For example, in some cases, a portion (e.g., half) of Schlemm's canal may be dilated (e.g., with a fluid composition) and the trabecular meshwork of the same or a different portion of Schlemm's canal may be disrupted or severed within the same eye. As another example, all of Schlemm's canal may be dilated, and then all or a portion of the trabecular meshwork may be disrupted or severed. This may be desirable, for example, to dilate the collecting canal and disrupt or sever the trabecular meshwork.

[0181] In some of these variations, the dilation and tearing or cutting can be performed using a single delivery system, such as those described herein, configured to deliver the fluid composition. For example, an elongate member of a delivery system configured to deliver the fluid composition can first deliver the fluid composition to a portion of Schlemm's canal (e.g., about a 180-degree arc of the canal, about a 90-degree arc of the canal) as described herein, and then be used to tear or cut the trabecular meshwork within the same portion of the canal as described herein. As another example, a conduit of a delivery system configured to deliver the fluid composition can first deliver the fluid composition to a portion of Schlemm's canal (e.g., about a 180-degree arc of the canal, about a 90-degree arc of the canal, etc.), and then be used to tear or cut the trabecular meshwork within another portion of the canal (e.g., another about a 180-degree arc of the canal, another 90-degree arc, etc.). As yet another example, an elongate member of a delivery system configured to deliver a fluid composition can be used to first deliver the fluid composition to all of Schlemm's canal (e.g., by delivering about 180 degrees of the fluid composition in a first direction, then delivering about 180 degrees of the fluid composition in a second direction), and then tear or cut the entire 360 ​​degrees of the trabecular meshwork (e.g., by tearing or cutting about 180 degrees of the trabecular meshwork in a first direction, then tearing or cutting about 180 degrees of the trabecular meshwork in a second direction). In another example, an elongate member of a delivery system configured to deliver a fluid composition can be used to first deliver the fluid composition to all of Schlemm's canal in one step (i.e., by delivering about 360 degrees of the fluid composition to Schlemm's canal in a single direction), and then tear or cut the entire 360 ​​degrees of the trabecular meshwork in a single step (i.e., by tearing or cutting about 360 degrees of the trabecular meshwork in a single direction).

[0182] In other variations, the dilating and tearing or cutting may be performed using different delivery systems (e.g., the dilating may be performed using a delivery system configured to deliver a fluid composition, and the tearing or cutting may be performed using a delivery system not configured to deliver a fluid). In another example, in some cases, the dilating may be performed in one eye of the patient, while the trabecular meshwork may be teared or cut in the other eye of the patient.

[0183] Procedures involving dilating Schlemm's canal and / or disrupting or severing the trabecular meshwork may also be combined with procedures to deliver an ocular device, either in the same eye or a different eye of the same patient. For example, all or a portion of Schlemm's canal may be dilated, followed by insertion of an ocular device. As another example, a portion of the trabecular meshwork may be disrupted or severed while an ocular implant is delivered to another portion of Schlemm's canal. In another example, a portion of Schlemm's canal may be dilated while an ocular implant is delivered to another portion of Schlemm's canal. In another example, an ocular implant may be delivered to a portion of Schlemm's canal, followed by dilating Schlemm's canal to improve the function of the ocular implant.

[0184] Any suitable ophthalmic device that maintains the patency of Schlemm's canal or improves the outflow of aqueous humor may be implanted. For example, an ophthalmic device that maintains the patency of Schlemm's canal without substantially impeding fluid flow across, along, or exiting Schlemm's canal may be implanted. Such a device may include a support having at least one fenestration, as disclosed in U.S. Patent No. 7,909,789 and U.S. Patent No. 8,529,622, which have been previously incorporated by reference in their entireties. Ophthalmic devices that disrupt the juxtacanalicular trabecular meshwork or the adjacent inner wall of Schlemm's canal may also be implanted. In addition to ophthalmic devices made of metals or metal alloys, sutures, modified sutures, modified polymers, polymer filaments, or solid viscoelastic structures may be used.

[0185] Other variations of the Abinterno method include the use of an endoscope. Similar to the method just described, access to the anterior chamber is first achieved by making an incision in the cornea, limbus, or sclera. Again, this can be performed in conjunction with cataract surgery, either before or after cataract surgery, all at once, or independently. To prevent collapse of the anterior chamber, saline may be infused into the anterior chamber, or a viscoelastic composition may be placed in the anterior chamber. The saline or viscoelastic may be delivered as a separate step, or may be injected using the elongated member of the delivery system, an irrigation sleeve on the elongated member or cannula, or a separate injection cannula. The surgeon then advances the endoscope through the incision toward the angle and trabecular meshwork under direct microscopic visualization. Once the surgeon visualizes the trabecular meshwork via the endoscope or any associated display, the bevel of the cannula advances, puncturing the trabecular meshwork. The elongated member is then advanced under endoscopic visualization. The elongated member may be advanced any suitable amount and direction around the canal. For example, the elongate member can be advanced from about 10 degrees to about 360 degrees around the vessel, or it can be advanced in two steps, e.g., 180 degrees clockwise and 180 degrees counterclockwise around the vessel (thereby achieving a full 360-degree abinternoviscocanalostomy). Once the elongate member is positioned within the vessel, a fluid composition, e.g., a viscoelastic fluid, can be delivered continuously or intermittently through the lumen of the elongate member. The fluid composition may exit the lumen of the elongate member through its distal end (e.g., through the distal tip), through openings or fenestrations provided along its shaft, or a combination of both. The openings or fenestrations can be spaced along the axial length of the elongate member in any suitable manner, e.g., symmetrically or asymmetrically along its length. If desired, other substances, such as drugs, air, or gas, can be delivered in the same manner. The elongate member can be repositioned by retraction or repeated advancement and retraction. In some variations of the method, the same or a different incision may be used, but the cannula of the delivery system is employed to access and dilate Schlemm's canal from a different direction (e.g., counterclockwise instead of clockwise).Once a sufficient amount of fluid has been delivered, the surgeon may retract the slidable elongate member into the cannula. In some variations, the surgeon may then remove the delivery system from the eye, while in other variations, the surgeon may keep the delivery system in the eye and perform the trabeculotomy, as described in more detail herein.

[0186] Tissue disruption is at least about 1 μl, at least about 2 μl, at least about 3 μl, at least about 4 μl, at least about 5 μl, at least about 6 μl, at least about 7 μl, at least about 8 μl, at least about 9 μl, at least about 10 μl, at least about 11 μl, at least about 12 μl, at least about 13 μl, at least about 14 μl, at least about 15 μl, at least about 16 μl, at least about 17 μl, at least about 18 μl, at least about 19 μl, at least about 20 μl, at least about 21 μl, at least about 22 μl, at least about 23 μl, at least about 24 μl, at least about 25 μl, at least about 26 μl, at least about 27 μl, at least about 28 μl, at least about 29 μl, at least about 30 μl, at least about 31 μl, at least about 32 μl, at least about 33 μl, at least about 34 μl, at least about 35 μl, at least about 36 μl, at least about 37 μl, at least about 38 μl, at least about 39 μl, at least about 40 μl, at least about 41 μl, at least about 42 μl, at least about 43 μl, at least about 44 μl, at least about 45 μl, at least about 46 μl, at least about 47 μl, at least about 48 μl, at least about 49 μl, at least about 50 μl, at least about 51 μl, at least about 52 μl, at least about 53 μl, at least about 54 μl, at least about 55 μl, at least about 56 μl, at least about 57 μl, at least This can occur by deliberately using excessive viscous expansion using 9 μl, at least about 20 μl, at least about 21 μl, at least about 22 μl, at least about 23 μl, at least about 24 μl, at least about 25 μl, at least about 26 μl, at least about 27 μl, at least about 28 μl, at least about 29 μl, at least about 30 μl, at least about 35 μl, at least about 40 μl, at least about 45 μl, or at least about 50 μl of viscoelastic fluid. In some variations, at least about 20 μl, at least about 25 μl, at least about 30 μl, at least about 35 μl, at least about 40 μl, at least about 45 μl, or at least about 50 μl of viscoelastic fluid can be delivered. In other variations, at least about 55 μl, about 60 μl, about 65 μl, about 70 μl, about 75 μl, about 80 μl, about 85 μl, about 90 μl, or about 100 μl of viscoelastic fluid may be delivered.

[0187] Depending on factors such as the type or severity of the condition being treated, the disruptive force can be generated to partially or completely disrupt and / or remove the trabecular meshwork and can be adjusted by varying the volume of viscoelastic fluid delivered.

[0188] Additionally, the fluid composition can be delivered to restore the tubular anatomical structure of Schlemm's canal, remove intracanalicular obstructions, destroy the juxtacanalicular trabecular meshwork or the inner wall of Schlemm's canal, or dilate the canal. Here, the delivery system may include wires, tubes, balloons, instruments that deliver energy to tissue, and / or other features useful for these methods. It is envisioned that glaucoma can be treated using such systems with additional features. The surfaces of these systems may also be roughened or have protrusions to further destroy the inner wall of Schlemm's canal and juxtacanalicular trabecular meshwork to enhance aqueous humor outflow or permeability. Additionally, it should be understood that the delivery systems described herein can be used to deliver fluid compositions to the anterior chamber or anterior segment of the eye.

[0189] Trabeculotomy The methods described herein may include performing a trabeculotomy. The methods (and systems and devices) described herein, including methods for providing a disruptive force to trabecular canalicular tissue, may be well suited for abinternotrabeculotomy and goniotomy, given that they avoid the use of electrocautery and allow the elongated member to be advanced over a greater angle of the arc of Schlemm's canal. In some cases, disruption tools may include disruption components on their distal portions. Exemplary disruption components include, but are not limited to, notches, hooks, barbs, balloons, or combinations thereof. In other instances, disruption tools may not include disruption components on their distal portions and may actually have a blunt, atraumatic distal portion. Exemplary atraumatic distal portions include, but are not limited to, parasol- or dome-shaped distal portions.

[0190] The outer diameter of the elongated member or tool can be varied to disrupt tissue, similar to how fluid volume can be varied to vary the level of disruption. For example, an elongated member or tool having an outer diameter in the range of about 50 to about 100 microns can be advanced through a vessel, slightly dilating the vessel and disrupting or removing septa that obstruct circumferential canalicular flow. An elongated member or tool having an outer diameter in the range of about 100 to about 200 microns can be used to accomplish the above and also to initiate stretching of the trabecular meshwork and juxtacanalicular tissue. An elongated member or tool having an outer diameter in the range of about 200 to about 300 microns can accomplish the above, but may also create microtears in the trabecular meshwork and juxtacanalicular tissue, or may maximally dilate the collecting canals. An elongated member or tool having an outer diameter in the range of about 300 to about 500 microns can maximize tissue disruption, creating tears or perforations along the entire trabecular meshwork and juxtacanalicular tissue. The elongate member or tool may be advanced from the tip of the cannula into the canal along about a 30-degree arc of the canal (e.g., about 3-4 mm advancement out of the cannula), about a 60-degree arc of the canal (e.g., about 6-8 mm advancement out of the cannula), about a 90-degree arc of the canal (e.g., about 10 mm advancement out of the cannula), about a 120-degree arc of the canal (e.g., about 15 mm advancement out of the cannula), about a 180-degree arc of the canal (e.g., about 20 mm advancement out of the cannula), or a full 360-degree arc of the canal (e.g., about 36-40 mm advancement out of the cannula) for maximum intraocular pressure reduction. In some variations, the elongate member may have a non-uniform outer diameter. For example, the elongate member may have a tapered outer diameter such that the outer diameter increases from the distal end to the proximal end.

[0191] In some variations, the methods disclosed herein may include advancing an elongate member between an approximately 5-degree arc and an approximately 360-degree arc of Schlemm's canal. In some variations, the methods may include advancing an elongate member (or tool) around a 360-degree arc of Schlemm's canal, a 270-degree arc of Schlemm's canal, a 120-degree arc of Schlemm's canal, a 180-degree arc of Schlemm's canal, or a 90-degree arc of Schlemm's canal. In yet further variations, advancement of the elongate member (or tool) may occur around an approximately 0-5-degree arc of Schlemm's canal, an approximately 30-degree arc of Schlemm's canal, or an approximately 60-degree arc of Schlemm's canal. Advancement may occur from a single access point within Schlemm's canal or from multiple access points within the canal. It may be beneficial to advance the elongate member in both clockwise and counterclockwise directions around a 180-degree arc of Schlemm's canal from a single access point within Schlemm's canal. In other variations, the elongate member may be advanced in a single direction (clockwise or counterclockwise) through approximately 360 degrees of Schlemm's canal from a single access point within the canal.

[0192] Depending on factors such as the type or severity of the condition being treated, the disruptive force can be generated to partially or completely disrupt and / or remove the trabecular meshwork and can be adjusted by varying the tool configuration. In some methods, the trabecular meshwork can be disrupted during advancement of the slidable elongate member. Customizing the body segment of the elongate member proximal to the tip with one or more notches, barbs, or balloons that capture the meshwork as the distal tip is guided and advanced along Schlemm's canal can also be used, thereby disrupting, partially tearing, completely tearing, and / or detaching the trabecular meshwork upon advancement. Additionally, implants with edges specially designed to cut the meshwork can be used.

[0193] In still other methods, the trabecular meshwork can be disrupted during retraction of the slidable elongate member. Methods for disrupting tissue can involve customizing a system (e.g., the elongate member, any catheter or wire, probe tip, etc.) to capture or grasp the meshwork upon retraction after advancing it through the canal. This can be done using a wire with a bent tip, hooks, notches, or barbs on its end that is advanced through the lumen of the catheter and then hooks the meshwork, tears it along its length, or completely detaches it upon retraction, or using only a metal or polymer wire or suture (without a catheter) with hooks, notches, or barbs attached in such a way that its tip (and / or body) can be advanced into Schlemm's canal without tearing the meshwork, but hooks, tears the meshwork, and / or completely detaches it upon retraction. The elongate member can be equipped with a disruption tool, e.g., a sharp element, that can cut or tear the trabecular meshwork while being retracted within a cannula that is held stationary. Exemplary sharp edge elements may be hooks, wires, or any other suitable shape memory components that may extend from the cannula to disrupt, cut, or detach the trabecular meshwork.

[0194] Another method for disrupting tissue may involve using an oversized elongate member (e.g., having an outer diameter of 300-500 microns) to rupture the meshwork upon delivery, or expanding or dilating the elongate member once it has fully advanced into Schlemm's canal to stretch, disrupt, rupture, or completely rupture the meshwork. For example, a catheter / elongate member, probe, or wire (with or without a lumen) may be used that has an outer diameter of 200-250 microns at its tip but has a shaft that begins to flare out to about 300 microns, 400 microns, or 500 microns after 3 clock hours of Schlemm's canal (i.e., at about the 5 or 10 mm mark on the catheter / elongate member), so that once the tip is comfortably advanced within Schlemm's canal, the enlarged shaft trails behind the trabecular meshwork as it advances, rupturing it.

[0195] Alternatively, cutting, disrupting, removing, etc., the trabecular meshwork may be accomplished by removing the cannula from the eye while leaving the elongated member within the canal, thereby disrupting the trabecular meshwork. For example, a cannula may be inserted into the anterior chamber and Schlemm's canal, and a tool (e.g., a slidable elongated member) may be advanced within the canal. The cannula may be removed from the anterior chamber without retracting the elongated member. This action may itself disrupt the trabecular meshwork. Once the cannula is removed from the anterior chamber, the elongated member may begin to tear the trabecular meshwork from the point where the cannula was inserted into Schlemm's canal, and may continue to tear around the trabecular meshwork toward the distal end of the elongated member.

[0196] The methods described herein can be used to access the trabecular outflow system using a single clear corneal incision, allowing for up to 360 degrees of transluminal trabeculotomy. The methods can use a flexible, elongated member that can be advanced and retracted using a single-handed disposable manual instrument. In one variation of the method, the cannula can be securely held at an angle while the flexible, elongated member is advanced into Schlemm's canal. The exposed portion of one or more of the wheels can be rotated proximally to advance the flexible, elongated member up to approximately 180 degrees around Schlemm's canal (approximately 20 mm of circumferential canal movement). For example, the elongated member can be advanced approximately 90 degrees, 135 degrees, or 180 degrees. At this point, the flexible, elongated member may be fully extended, in some cases, and the wheel may no longer be able to rotate. Direct microscopic or gonioscopic visualization of the cannula tip can be maintained during this procedure, and the anterior chamber can be maintained using viscoelastic or continuous balanced salt solution infusion. As the flexible elongate member is advanced, the cannula can be removed from the eye through the incision without retracting the flexible elongate member, which could cause the body of the flexible elongate member to tear or cut the trabecular meshwork. In some cases, it may be desirable to bias the distal tip of the cannula toward the trabecular meshwork to be cut, which may help in some cases to prevent the flexible elongate member from slipping out of the canal during removal of the cannula.

[0197] The methods are generally minimally invasive, single-handed, single-operator controlled methods, e.g., they are tailored for ab interno procedures, which, as mentioned above, may be advantageous over more invasive ab externo approaches. However, use of the system in ab externo procedures may be contemplated in some cases and is therefore not excluded here. The methods may be used to treat or prevent glaucoma, pre-glaucoma, or ocular hypertension. When treating glaucoma, the methods may also be used in conjunction with cataract surgery (pre- or post-) using the same incision during the same session or at a different time.

[0198] Throughout this application, the term "about" is used to indicate that a value includes the inherent variation of error for the device or method employed to determine the value or the variation that exists between samples measured. Unless otherwise stated or clear from the context, the term "about" means within 10% above or below the reported numerical value (except where such numerical value would exceed 100% or be less than 0% of the possible values). When used in conjunction with a range or series of values, the term "about" applies to the endpoints of the range or to each of the values ​​recited in the series of ranges, unless otherwise indicated. As used herein, the terms "about" and "approximately" are used interchangeably.

[0199] While variations of the present invention have been shown and described herein, those skilled in the art will understand that such variations are provided by way of example only. Numerous variations, changes, and substitutions will occur to those skilled in the art without departing from the invention. It should be understood that various alternatives to the variations of the present invention described herein may be employed in practicing the invention. It is intended that the following claims define the scope of the invention, and that methods and structures within the scope of these claims and their equivalents be covered thereby.

Claims

1. A device for delivering fluid to the eye, wherein the device is A handle with a housing that contains a fluid reservoir, A cannula connected to the distal end of the handle, An elongated member slidably positioned within the cannula, A connector releasably coupled to the fluid reservoir within the handle and Equipped with, The connector is configured to receive an external fluid device for transferring fluid into the fluid reservoir, and to be released from the handle while the external fluid device is coupled to the connector.

2. The device according to claim 1, wherein the handle includes a proximal portion having a proximal cavity having a proximal opening, the proximal cavity having a coupling hub therein, and the coupling hub includes a coupling portion.

3. The device according to claim 2, wherein the connector engages with the coupling portion of the coupling hub.

4. The device according to claim 3, wherein the coupling portion includes a thread configured to engage with the distal luminal wall of the connector.

5. The device according to claim 2, wherein the handle is provided with a sealing member distal to the coupling hub, and the sealing member is configured to seal the fluid reservoir.

6. The device according to claim 2, wherein the connector comprises a connector body including one or more extensions configured to engage with one or more contact portions in the proximal cavity of the handle when the connector is coupled to the coupling hub.

7. The device according to claim 2, wherein the coupling hub includes a plug having a plug lumen that is in fluid communication with the fluid reservoir.

8. The device according to claim 1, wherein the housing comprises a distal portion of the handle, and the distal portion includes a gripping portion proximal to the distal end of the handle.

9. The device according to claim 8, wherein the gripping portion includes a textured surface having raised elements, recessed elements, or a combination thereof.

10. The device according to claim 9, wherein the textured surface includes raised or recessed elements having the same shape.

11. The device according to claim 9, wherein the textured surface includes raised or recessed elements having different shapes.

12. The device according to claim 10 or claim 11, wherein the textured surface includes raised or recessed elements, and the raised or recessed elements have the same cross-sectional area or the same diameter.

13. The device according to claim 10 or claim 11, wherein the textured surface includes raised or recessed elements, the raised or recessed elements having different cross-sectional areas or different diameters.

14. The device according to claim 8, wherein the gripping portion includes an upper surface and a lower surface, and the upper surface or the lower surface includes one or more actuators.

15. The device according to claim 8, wherein the gripping portion is symmetrical across the YZ plane.

16. The device according to claim 8, wherein the gripping portion is symmetrical across the XZ plane.

17. The device according to claim 8, wherein the gripping portion is symmetrical with respect to the YZ plane and the XZ plane, respectively.

18. The device according to claim 14, wherein the gripping portion includes the minimum height at the distal end of the handle and the maximum height at the proximal end of the handle.

19. The device according to claim 14, wherein the gripping portion has two or more cross-sectional shapes along the longitudinal axis of the handle.

20. The device according to claim 19, wherein the central section of the gripping portion has an elliptical cross-sectional shape having a major axis and a minor axis, and the central section of the gripping portion includes the top surface, the bottom surface, and one or more actuators.

21. The device according to claim 20, wherein the gripping portion comprises a circular cross-sectional shape having a first diameter proximal to the central section and a circular cross-sectional shape having a second diameter distal to the central section, the first diameter being larger than the second diameter.

22. A system for delivering fluid to treat an eye condition, the system is A delivery device comprising a handle with a housing, a cannula coupled to the handle, a fluid reservoir, and an elongated member, wherein the elongated member is in fluid communication with the fluid reservoir and is slidably positioned within the cannula. An external fluid device coupled to the connector of the handle of the delivery device, wherein the connector is releasably coupled to the fluid reservoir housed within the housing of the delivery device. Equipped with, The fluid is delivered from the external fluid device through the connector. The connector is configured to be removed from the delivery device while the external fluid device is coupled to the connector. The cannula of the delivery device is configured to be advanced toward the eye. The aforementioned elongated member is configured to be moved forward around the Schlemm tube, The system is configured such that the elongated member delivers fluid to the eye.

23. The system according to claim 22, wherein the connector is configured to be rotated to remove the connector and the external fluid device from the delivery device.

24. The system according to claim 23, wherein the connector is configured to be removed from the proximal cavity in the handle.

25. The system according to claim 24, wherein the connector is configured to be rotated to disengage the connector from the coupling hub in the proximal cavity of the handle.

26. The system according to claim 23, wherein the connector is configured to be rotatable using one or more tabs extending from the connector body in a second direction opposite to a first direction.

27. A device for delivering fluid to the eye, wherein the device is It has a handle that houses a fluid reservoir inside, A cannula connected to the distal end of the handle, wherein the cannula has a curved proximal portion, a curved distal portion, and a distal tip, the curved proximal portion having a first radius of curvature, the curved distal portion having a second radius of curvature, the first radius of curvature being greater than the second radius of curvature, and the first and second radii of curvature being in opposite directions, An elongated member is slidably positioned within the cannula and configured to deliver fluid to the Schlemm tube. A device equipped with the following features.

28. The device according to claim 27, wherein the distal tip is located on the inner radius of the cannula.

29. The device according to claim 27, wherein the distal tip is located on the outer radius of the cannula.

30. The device according to claim 27, wherein the distal tip further comprises a distal edge having a straight portion, a proximal edge having a curved portion, and a luminal opening.

31. The device according to claim 30, wherein the straight portion and outer radius of the distal edge form an angle of about 14 degrees to about 20 degrees.

32. The device according to claim 30, wherein the distal edge or the proximal edge is chamfered.

33. The device according to claim 30, wherein the distal tip portion comprises a distal margin including a lateral distal margin and a medial distal margin that define the tongue.

34. The device according to claim 30, wherein the proximal margin further comprises an inner proximal margin and an outer proximal margin defining the base.

35. The device according to claim 30, wherein the distal edge is rounded or straight.

36. The device according to claim 30, wherein the diameter of the distal tip is tapered from the proximal edge to the distal edge.

37. The device according to claim 30, wherein the distal tip portion further comprises a linear portion including one or more linear segments.

38. The device according to claim 37, wherein the linear portion includes a plurality of linear segments, each segment having a different inclination.

39. The device according to claim 30, wherein the distal tip portion further includes a curved portion comprising one or more curved segments.

40. The device according to claim 39, wherein the curved portion includes a plurality of curved segments, each segment having a different radius of curvature.

41. The device according to claim 30, wherein the distal tip portion has a length along the longitudinal axis from the distal edge to the proximal edge.

42. The device according to claim 41, wherein the length of the straight portion is greater than the length of the curved portion, constituting a ratio of the length of the distal tip.

43. The device according to claim 41, wherein the length of the curved portion is greater than the length of the straight portion, constituting a ratio of the length of the distal tip.

44. The device according to claim 41, wherein the cannula further comprises an outer wall and an inner wall defining the thickness of the wall.

45. The device according to claim 44, wherein the thickness of the wall is tapered along the length of the distal tip.

46. The device according to claim 45, wherein the thickness of the wall is tapered along the length of the straight portion.

47. The device according to claim 45, wherein the thickness of the wall is tapered along the length of the tongue portion of the straight section.

48. The device according to claim 44, wherein the thickness of the wall is constant along the length of the distal tip.

49. The device according to claim 48, wherein the thickness of the wall is constant along the length of the straight portion.

50. The device according to claim 48, wherein the thickness of the wall is constant along the length of the tongue portion of the straight section.

51. The device according to claim 27, wherein the distal tip of the cannula is aligned with the central longitudinal axis of the handle.

52. The device according to claim 51, wherein the distal tip of the cannula is divided by the central longitudinal axis of the handle.

53. The device according to claim 51, wherein the curved proximal portion and the curved distal portion are offset from the central longitudinal axis of the handle.

54. A device for delivering fluid to the eye, wherein the device is A handle comprising a housing that at least partially houses a fluid reservoir, the handle comprising a housing having a proximal portion and a distal portion having a gripping portion, the gripping portion comprising a first curved side surface, a second curved side surface opposite the first curved side surface, and a tapered region distal to the first and second curved side surfaces, the tapered region being configured to receive the fingers of the user, A cannula connected to the distal end of the handle, An elongated member is slidably positioned within the cannula and configured to deliver fluid to the Schlemm tube. A device equipped with the following features.

55. The device according to claim 54, wherein the first and second curved sides are convex.

56. The device according to claim 55, wherein the first and second curved sides are symmetrical with respect to an XZ plane parallel to the midpoint in the longitudinal direction.

57. The device according to claim 54, wherein the gripping portion comprises an actuator configured to move the elongated member and / or deliver fluid.

58. The device according to claim 57, wherein the gripping portion further comprises an actuator boundary around the actuator.

59. The device according to claim 57, wherein the gripping portion further comprises a planar surface near the actuator.

60. The device according to claim 59, wherein the gripping portion further comprises an actuator boundary around the actuator, and the actuator boundary is continuous with the planar surface.

61. The device according to claim 59, wherein the planar surface is a first planar surface, the gripping portion further comprises a second planar surface, the first planar surface is located on the upper part of the handle, and the second planar surface is located on the bottom of the handle.

62. The device according to claim 61, further comprising a second actuator, wherein the first actuator is located on the upper part of the handle, the second actuator is located on the bottom of the handle, and the second planar surface is located proximal to the second actuator.

63. The device according to claim 57, wherein the gripping portion further comprises a neck proximal to the actuator.

64. The device according to claim 63, wherein the proximal portion has a first height at its distal end, the neck has a second height, the distal portion has a maximum height aligned with at least a portion of the actuator, and the first height and the maximum height are greater than the second height.

65. The device according to claim 54, wherein the gripping portion is provided with an anti-slip material on the tapered region.

66. The device according to claim 65, wherein the gripping portion comprises an actuator configured to move the elongated member and / or deliver fluid, and the anti-slip material extends beyond the actuator and terminates adjacent to the distal end of the handle.

67. The device according to claim 65, wherein the anti-slip material surrounds the tapered portion.

68. The device according to claim 54, wherein the first curved side surface has a first arc having a first center, and the second curved side surface has a second arc having a second center, and the first and second centers are on either side of the central longitudinal axis of the cannula.

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