Ocular delivery systems and methods

Abstract

Devices for delivering fluids to an eye are disclosed herein. The device may include: a handle including a housing at least partially including a fluid reservoir therein; a cannula coupled to the distal end of the housing; and an elongate member slidably positioned within the cannula. The device may include a connector releasably coupled to the fluid reservoir in the handle, where the connector is 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, where the first radius of curvature is greater than the second radius of curvature, and where the first radius of curvature and the second radius of curvature are in opposite directions.

Description

[0001] Incorporated by Reference

[0002] This application claims priority to U.S. Provisional Application Serial No. 63 / 400,267, filed on August 23, 2022, which is hereby incorporated by reference in its entirety. Technical Field

[0003] The present invention generally relates to fluid delivery systems for treating conditions of the eye, and related methods for treating such conditions of the eye. Background Art

[0004] Glaucoma is a potentially blinding disease that affects more than 60 million people worldwide, or about 1% to 2% of the population. Typically, glaucoma is characterized by increased intraocular pressure. Increased pressure within the eye can cause irreversible damage to the optic nerve, which can lead to vision loss and even blindness if untreated. Sustained reduction of intraocular pressure can slow or stop the progressive vision loss associated with glaucoma.

[0005] Increased intraocular pressure is usually caused by suboptimal outflow or drainage of fluid (aqueous humor) from the eye. Aqueous humor or aqueous humor fluid is a clear, colorless liquid that is continuously replenished in the eye. Aqueous humor is produced by the ciliary body and then eventually leaves the eye primarily through the trabecular meshwork. The trabecular meshwork extends circumferentially 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 protrusion and the peripheral cornea. The trabecular meshwork enters Schlemm's canal outward, which is a narrow circumferential passage that generally surrounds the outer boundary of the trabecular meshwork. Positioned around Schlemm's canal and extending radially from Schlemm's canal are aqueous humor veins or collecting channels that receive the fluid that is drained. The net drainage or outflow of aqueous humor may be reduced due to reduced outflow facilities, reduced outflow through the trabecular meshwork and the tube of Schlemm's drainage device, increased episcleral venous pressure, or possibly increased aqueous humor production. Flow out of the eye may also be restricted by blockage or constriction in the trabecular meshwork and / or Schlemm's canal and its collecting channels.

[0006] Glaucoma, pre-glaucoma and high intraocular pressure can currently be treated by reducing intraocular pressure using one or more methods, including drugs, incisional surgery, laser surgery, cryosurgery and other forms of surgery. Typically, drugs or medical therapy are the first line of therapy. If medical therapy is not effective enough, more invasive surgical treatments can be used. For example, the standard incisional surgical procedure used to reduce intraocular pressure is trabeculectomy or filtering surgery. The operation involves creating a new drainage site for the aqueous humor. Instead of natural drainage through the trabecular meshwork, a new drainage path is created by removing a portion of the sclera and trabecular meshwork at the drainage angle. This forms an opening or channel between the anterior chamber and the subconjunctival space, which is drained by conjunctival blood vessels and lymphatic vessels. The new opening can be covered with sclera and / or conjunctiva to form a new reservoir called a bleb, into which the aqueous humor can be drained. However, traditional trabeculectomy surgery has short-term and long-term risks. These risks include obstruction of the surgical opening by scarring or other mechanisms, hypotony or abnormally low intraocular pressure, expulsion hemorrhage, hyphema, intraocular infection or endophthalmitis, shallow anterior chamber angle, macular hypotony, choroidal effusion, and suprachoroidal hemorrhage.

[0007] An alternative is to implant a device in Schlemm's canal that keeps the canal open or helps aqueous humor flow into the canal from the anterior chamber. Various stents, shunts, catheters and surgeries have been designed for this purpose, and an external route (from the outside of the eye) method is used to deliver implants or catheters into Schlemm's canal. This placement method is invasive and usually long-term, requiring the creation of a tissue flap and deep peeling to approach the canal. In addition, since Schlemm's canal has a small diameter, such as a cross-sectional diameter of approximately 50 microns to 250 microns, and even smaller when collapsed, it is difficult for many surgeons to find and approach Schlemm's canal from the external incision method. A related non-implantation surgery, i.e., external canaloplasty, involves making a deep scleral incision and flap, finding and removing the top of Schlemm's canal, surrounding all 360 degrees of the canal with a catheter from the outside of the eye, and using viscoelastics, circumferential tensioning sutures or both to help keep the canal open. The procedure is quite challenging and may take 45 minutes to 2 hours. Although the long-term safety and efficacy of viscocanaloplasty are very promising, the procedure remains surgically challenging and invasive.

[0008] Another alternative is viscoelastic canalillotomy, which involves the injection of a viscoelastic solution into Schlemm's canal to dilate the canal and associated collecting channels. Dilation of the canal and collecting channels in this manner generally facilitates drainage of aqueous humor from the anterior chamber through the trabecular meshwork and Schlemm's canal and out through the natural trabeculocanalicular outflow pathway. Viscoelastic canalillotomy is similar to viscocanaloplasty (both are invasive and external), except that viscoelastic canalillotomy does not involve sutures and does not restore all 360 degrees of outflow facilities. Some advantages of viscoelastic canalillotomy are that a sudden drop in intraocular pressure, hyphema, hypotony, and a flat anterior chamber can be avoided. The risk of cataract formation and infection can also be minimized because intraocular manipulation is reduced and there is no complete eye wall penetration, anterior chamber opening and shallowing, and iridectomy. Another advantage of viscoelastic canalicular incision is that the procedure restores the physiological outflow path, thereby avoiding the need for external filtration in most eyes, and its associated short-term and long-term risks. This makes the success of the procedure partially independent of scarring on the conjunctiva or sclera, which is the main reason for failure of traditional trabeculectomy surgery. In addition, 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 path.

[0009] However, due to the need to approach Schlemm's canal by making a deep incision in the sclera, forming a scleral flap and removing the canal, the external viscoelastic canalectomy and viscocanaloplasty techniques are still very invasive. "External" usually refers to "from the outside", and it is inherently more invasive considering the location of Schlemm's canal and the amount of tissue destruction required to approach it from the outside. On the other hand, "internal" refers to "from the inside", and is a less invasive method because the amount of tissue destruction required to approach it from the inside is reduced. Therefore, the internal approach to Schlemm's canal makes it easier for surgeons to approach the canal, and reduces the risk to the patient's eyes and reduces the morbidity of the patient. All of these lead to improved patient recovery and rehabilitation. Because as previously mentioned, due to the small diameter of Schlemm's canal, it is difficult to find and approach Schlemm's canal from the outside using a deep incision method, so for surgeons, external viscoelastic canalectomy and viscocanaloplasty are still challenging. Yet another disadvantage is that in most cases, viscoelastic canalectomy usually dilates Schlemm's canal, which is a 360-degree circular outflow vessel-like structure, up to 60 degrees. The more canal that can be dilated, the more total aqueous humor outflow can be restored.

[0010] Therefore, it would be beneficial to have a system that uses an intra-path method for delivering tools and fluid compositions to easily and non-traumatically provide access to Schlemm's canal. It would also be useful to have a system that quickly delivers tools and compositions into Schlemm's canal to reduce surgical time and infection risk without compromising the safety and precision of the delivery surgery. It would also be useful to have a system that uses an intra-path method to deliver tools and fluid compositions into Schlemm's canal so that both cataract surgery and glaucoma surgery can be performed using exactly the same corneal or scleral incision during the same surgery. Such incisions are smaller and achieve less invasive surgery and faster patient recovery. This method allows access to Schlemm's canal from the inside of the eye through the trabecular meshwork, and is thus referred to as an "internal route". Also contemplated are methods of delivering devices and compositions that effectively disrupt the wall of the juxtacanalicular network and adjacent Schlemm's canal (also referred to as the inner wall of Schlemm's canal), maintain patency of Schlemm's canal, increase outflow, reduce resistance to outflow, or effectively dilate the canal and / or its collecting channels in a minimally invasive, endo-access manner using a system. Summary of the invention

[0011] A device for delivering a fluid to an eye is disclosed herein. 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 also include a connector releasably coupled to the fluid reservoir in the handle, wherein the connector may be configured to receive an external fluid device to transfer the fluid into the fluid reservoir and to be released from the handle when the external fluid device is coupled to the connector.

[0012] In some variations, the handle may include a proximal portion including a proximal cavity having a proximal opening, the proximal cavity having a coupling hub within the proximal cavity, the coupling hub including a coupling portion. In some variations, the connector may engage the coupling portion of the coupling hub, and the coupling portion may include threads configured to engage a distal cavity wall of the connector.

[0013] In some variations, the handle may include a sealing member distal to the coupling hub configured to seal the fluid reservoir.

[0014] In some variations, the connector may include a connector body including one or more extensions configured to engage one or more abutments within a 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.

[0015] In some variations, the housing may include a distal portion of the handle, which may include a gripping portion proximal to the distal end of the handle.

[0016] 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 elements or recessed elements having the same shape. The textured surface may include raised elements or recessed elements having different shapes. The textured surface may include raised elements or recessed elements having the same cross-sectional area or the same diameter or different cross-sectional areas or different diameters.

[0017] In some variations, a gripping portion may include a top surface and a bottom surface, wherein the top surface or the bottom surface may include one or more actuators.

[0018] The gripping portion may be symmetrical across the YZ plane, symmetrical across the XZ plane, or symmetrical across each of the YZ plane and the XZ plane.

[0019] In some variations, the gripping portion may comprise a maximum height at the one or more actuators and a minimum height at the distal end of the handle.

[0020] In some variations, the gripping portion may comprise two or more cross-sectional shapes along the longitudinal axis of the handle.

[0021] In some variations, a central section of the gripping portion may include 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 include 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, wherein the first diameter is greater than the second diameter.

[0022] Also disclosed herein is a method of delivering a fluid to treat a condition of the eye. The method may include coupling an external fluid device to a connector of a handle of a delivery device, wherein the delivery device may include: a handle including a housing; a cannula coupled to the handle; a fluid reservoir; and an elongated member in fluid communication with the fluid reservoir, slidably positioned within the cannula. The method includes delivering a fluid from the external fluid device through a connector, the connector releasably coupled to a fluid reservoir included within a housing of the delivery device, and removing the connector from the delivery device with the external fluid device coupled to the connector. The method may also include advancing the cannula of the delivery device to the eye, advancing the elongated member around Schlemm's canal, and delivering the fluid to the eye through the elongated member.

[0023] 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 within 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 within the proximal cavity of the handle. Removing the connector and the external fluid device coupled to the connector from the delivery device includes extending the rotating connector in a second direction opposite to the first direction using one or more tabs extending from the connector body.

[0024] Also disclosed herein is a device for delivering a fluid to an eye. The device may include: a handle including a fluid reservoir; 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, wherein the curved proximal portion has a first radius of curvature and the curved distal portion has a second radius of curvature, wherein the first radius of curvature is greater than the second radius of curvature, and wherein the first radius of curvature and the second radius of curvature are in opposite directions. The device may also include an elongated member slidably positioned within the cannula and configured to deliver the fluid to Schlemm's canal.

[0025] The device also includes a distal tip, which also includes a distal edge having a straight portion, a proximal edge having a curved portion, and the lumen opening of the cannula. In some variations, the distal tip can be located on the inner radius of the cannula or on the outer radius of the cannula.

[0026] In some variations, the straight portion of the distal edge and the outer radius may form an angle of between about 14 degrees and about 20 degrees.The distal edge or the proximal edge may be chamfered, or both the distal edge and the proximal edge may be chamfered.

[0027] The distal edge may include an outer distal edge and an inner distal edge defining a tongue. The proximal edge may also include an inner proximal edge and an outer proximal edge defining a base. The distal edge may be rounded or straight.

[0028] In some variations, the diameter of the distal tip may taper from the proximal edge to the distal edge.

[0029] In some variations, the straight portion of the distal tip may include one or more straight segments.The straight portion of the distal tip may include multiple straight segments, wherein each segment has a different slope.

[0030] 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 a plurality of curved segments, wherein each segment includes a different radius of curvature. In some variations, the distal tip may have a length along the longitudinal axis from a distal edge to a proximal edge.

[0031] In some variations, 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. In some variations, the length of the curved portion may comprise a greater percentage of the length of the distal tip than the length of the straight portion.

[0032] 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.

[0033] In some variations, the distal tip of the cannula may be aligned with, or may be bisected by, the central longitudinal axis of the handle. In some variations, the curved proximal and distal portions may be offset from the central longitudinal axis of the handle.

[0034] Also disclosed herein is a device for delivering fluid to an eye. The device may include a handle including a fluid reservoir at least partially within the handle, 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 curved side and the second curved side, wherein the tapered region is configured to receive a user's finger. The device may also include a cannula coupled to the distal end of the handle and an elongated member slidably positioned within the cannula and configured to deliver the fluid to Schlemm's canal.

[0035] In some variations, the first curved side and the second curved side are convex.The first curved side and the second curved side may be symmetrical across an XZ plane parallel to the longitudinal midpoint.

[0036] In some variations, the gripping portion may include an actuator configured to move the elongated member and / or deliver the fluid. The gripping portion may also include an actuator boundary surrounding the actuator.

[0037] In some variations, the gripping portion may further include a planar surface proximal to the actuator. The planar surface may include a first planar surface, and the gripping portion may further include a second planar surface, wherein the first planar surface is on the top of the handle and the second planar surface is on the bottom of the handle. In some variations, the gripping portion may include a neck proximal to the actuator.

[0038] In some variations, the proximal portion can have a first height at the distal end, the neck can have a second height, and the distal portion can have a maximum height aligned with at least a portion of the actuator, and the first height and the maximum height can be greater than the second height. In some variations, the grip portion can include a non-slip material on the tapered portion. The grip portion can include an actuator configured to move the elongated member and / or deliver fluid, and the non-slip material extends beyond the actuator and terminates adjacent the distal end of the handle. The non-slip material can surround the tapered portion. BRIEF DESCRIPTION OF THE DRAWINGS

[0039] Figure 1 A stylized cross-sectional diagram showing the eye and some of the structures involved in the outflow of aqueous humor from the eye.

[0040] Figure 2 A perspective view of an exemplary delivery device is depicted.

[0041] Figure 3 Exploded views of variations of exemplary delivery devices are shown.

[0042] Figure 4A depicts a perspective view of a connector of a delivery system, and Figure 4B Depicted Figure 4A Front view of the connector.

[0043] Figure 5A Depicted is a perspective view of an exemplary delivery device having a handle with a housing including a gripping portion. Figure 5B Depicted Figure 5A Front view of the delivery device. Figure 5C Depicted Figure 5A Side view of an exemplary delivery device.

[0044] Fig. 6A A perspective view of the proximal end of the handle of a delivery device including a connector of a delivery system is depicted. Figure 6B Depicted include Fig. 6A The proximal end of the proximal opening of the handle. Figure 6C Depicted Fig. 6A Rear view of the proximal end of the handle.

[0045] Figure 7 A side view of an exemplary cannula of a delivery device is depicted.

[0046] FIG. 8A to FIG. 8E Depicted are side views of exemplary variations of cannulas.

[0047] Fig.9A Variations of the distal tip of the cannula are shown. Fig. 9B Shown Fig.9A A side view of the distal tip of Fig. 9C Depicted Fig.9A Side view of a variation of the distal tip.

[0048] Fig.10 A side view of the distal tip of the cannula is depicted.

[0049] FIG. 11A to FIG. 11L Further variations of the distal tip of the cannula are depicted.

[0050] FIG. 12A to FIG. 12C Depicted are exemplary delivery devices illustrating methods of delivering a fluid from an external fluid device to the delivery device according to some variations.

[0051] Fig.13 is a flow chart of an exemplary method for delivering fluid to Schlemm's canal using variations of the delivery systems described herein.

[0052] FIG. 14A to FIG. 14E Depicted is a side view of a distal end of an elongate member according to some variations. DETAILED DESCRIPTION

[0053] Described herein are systems and methods for approaching Schlemm's canal and for delivering fluid compositions therein and / or for tearing the trabecular meshwork to reduce intraocular pressure and thereby treat eye diseases. Certain components of the fluid and system (e.g., a slidable elongated member (e.g., a catheter)) can be used to provide a force for destroying trabecular meshwork tubular tissue, which includes trabecular meshwork, near tubular tissue, Schlemm's canal, and collecting channels. As used herein, the term "destruction" refers to the delivery of a certain volume of fluid or system components that changes tissue in a manner that improves the flow through the trabecular meshwork tubular outflow path. Examples of tissue destruction include, but are not limited to, expansion of Schlemm's canal, expansion of collecting channels, increasing the porosity of the trabecular meshwork, stretching the trabecular meshwork, forming microtears or perforations in near tubular tissue, removing septa from Schlemm's canal, cutting, tearing, or removing trabecular meshwork tubular tissue, or a combination thereof.

[0054] To better understand the systems and methods described herein, it may be helpful to explain some basic eye anatomy. Figure 1is a stylized depiction of a normal human eye. The anterior chamber (100) is shown as being bounded on its anterior surface by the cornea (102). The cornea (102) is connected on its periphery to the sclera (104), which is a tough fibrous tissue that forms the protective white outer shell of the eye. 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). Schlemm's canal (108) is located on the peripheral surface of the trabecular meshwork (106). Schlemm's canal (108) extends 360 degrees circumferentially around the meshwork (106). The anterior chamber angle (112) is at the vertex formed between the iris (110), the meshwork (106), and the sclera (104).

[0055] The delivery system is typically configured for one-handed manipulation and for control by a single operator, and includes one or more features for easily accessing Schlemm's canal with minimal trauma. Once access to the canal is obtained, the delivery system can deliver a fluid composition and / or tear the trabecular meshwork. For example, the lumen of the elongated member (e.g., catheter) can be configured to deliver the fluid composition to the canal, and the body of the elongated member can be configured to cut or tear through the trabecular meshwork if the system is removed from the eye while the elongated member is extended from the cannula and located within Schlemm's canal.

[0056] It should be understood that in some cases, the delivery systems described herein can be used to deliver a fluid composition only to Schlemm's canal (and not use, for example, the body of the elongated member to tear the trabecular meshwork alone) or can be used to tear the trabecular meshwork only (using, for example, the body of the elongated member) without delivering a fluid composition. In addition, as described above, in some cases, the delivery systems described herein can be used to deliver a fluid composition to Schlemm's canal and tear the trabecular meshwork.

[0057] In some variations, the methods described herein may include implanting a device completely or partially in Schlemm's canal together with delivering a fluid composition into the canal and / or tearing the trabecular meshwork. When the device is implanted in the canal, it will generally be configured to maintain the patency of Schlemm's canal without substantially interfering with the transmural fluid flow across the canal. This can restore, allow or enhance the normal physiological outflow of aqueous humor through the trabecular meshwork canal tissue. Eye implants such as those disclosed in U.S. Patent Serial No. 7,909,789 and those disclosed in U.S. Patent Serial No. 8,529,622 may be delivered, each of which is incorporated herein by reference in its entirety. In some variations, implants in U.S. Patent Serial No. 7,909,789 and U.S. Patent Serial No. 8,529,622 include a support member having at least one fenestration, and the at least one fenestration passes completely through the central core of Schlemm's canal without substantially interfering with the transmural fluid flow across or along Schlemm's canal or longitudinal fluid flow. The ocular device can also damage the adjacent inner wall of the juxtatubular trabecular meshwork or Schlemm's canal. The ocular device can also be coated with drugs for treating high intraocular pressure, glaucoma or pre-glaucoma, infection or scarring, neovascularization, fibrosis or postoperative inflammation. The ocular device can also be formed as a solid, semi-solid or bioabsorbable.

[0058] Delivery devices and systems

[0059] The systems described herein may generally include a one-handed, single operator controlled device and one or more external fluid delivery devices configured to deliver fluid to the delivery device and releasably coupled to the delivery device. The delivery device generally includes: a handle having a gripping portion and a housing having an inner and distal end; and a connector configured to be removably coupled to both the housing of the handle and the one or more external fluid devices. The delivery device may include a sleeve coupled to the distal end of the housing and extending from the distal end. The sleeve may include a proximal end, a straight portion, and a distal portion, wherein the curved portion has a proximal end and a distal end and one or more radii of curvature. In other variations, the entire sleeve may be straight, and therefore may not include a distal curved portion. The sleeve may also include an inner cavity extending from the proximal end through the distal tip, and the distal tip may include an opening to the inner cavity.

[0060] The device can also generally include a drive assembly partially included in the housing. In some variations, the drive assembly can include one or more gears that convert rotational movement into linear movement. The delivery device can also include a slidable elongated member coaxially arranged in the inner cavity of the sleeve. In some variations, the slidable elongated member can include an inner cavity passing through it. The delivery device can also include a fluid assembly at least partially contained in the handle. Fluid compositions, such as saline, viscoelastic fluids (including viscoelastic solutions), air and gas can be delivered using the delivery device of the system. Suitable markings, colors or indicators can be included on any part of the delivery device of the system to help identify the positioning or position of the distal end of the sleeve and / or the slidable elongated member.

[0061] In some cases, the systems described herein can be used to perform internal trabeculotomy, internal transluminal trabeculotomy, clear corneal trabeculotomy, clear transluminal corneal trabeculotomy, internal viscocanaloplasty, and / or clear viscocanaloplasty, and / or can be used to deliver a fluid composition to the anterior or posterior segment of the eye.

[0062] Figure 2 A portion of an exemplary delivery system is depicted in . As shown, the delivery system (200) may include a delivery device (201) having a universal handle (202) that includes a housing (206) having a gripping portion (204). The housing (206) has a proximal end and a distal end. A cannula (208) including a distal tip (232) may be coupled to the distal end of the housing and may extend from the distal end. The delivery device (201) may also include an elongated member (234) slidably positioned within the cannula (208). The distal tip (232) of the cannula (208) may be configured to provide enhanced functionality to a user when the cannula (208) is positioned in Schlemm's canal, as will be described in more detail herein. The delivery device (201) may also include a drive assembly substantially included within the housing (206). The drive assembly may be configured to actuate movement of the elongated member (234) and / or deliver a fluid composition to the eye. For example, as Figure 2 As shown, the drive assembly can include one or more actuators (210) (e.g., one, two, three, four, or more), such as a rotatable element (e.g., a wheel), a slider, a button, etc., actuation of which (e.g., rotation, translation, pressing) can advance and / or retract the slidable elongated member and / or can deliver the fluid composition. In some variations, one or more actuators (210) can extend out of the housing (206) for easier access by a user. For example, one or more actuators (210) can extend out of the housing of the handle, such as on opposite sides of the handle, such as Figure 2As will also be described in greater detail herein, the handle (202) is configured (e.g., size, shape (including curvature), placement of portions / components (e.g., actuator, gripping portion), etc.) to fit ergonomically in the hand of a user and provide easy and comfortable access to the actuator as well as rotation of the handle itself along the longitudinal axis of the handle, thereby allowing the user to easily control movement of the elongated member and / or fluid delivery.

[0063] The delivery device (201) of the delivery system (200) may also 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 the fluid composition may be delivered to the reservoir (212) through the connector (220). The connector (220) may be configured to be removably coupled to (e.g., releasably at least partially received therein) an external fluid device. In this manner, the connector (220) may be configured to easily allow a volume of the fluid composition to be transferred from the external fluid device to the reservoir (212). After transferring a volume of the fluid composition, the connector (220) can be separated from the delivery device (201) to help remove, release, or otherwise separate the external fluidic device from the housing (206) of the handle (202) of the delivery device (201). A delivery system (200) including a delivery device (201) will be described in more detail herein.

[0064] The delivery systems described herein, or components thereof, may in some variations be completely disposable. In other variations, a portion of the delivery system may be reusable (e.g., non-patient contacting materials, such as handle (202)), while a portion of the delivery system may be disposable (e.g., patient contacting materials, such as cannula (208) and elongated member (234)). In other variations, the delivery systems described herein may be completely reusable.

[0065] External fluid device and fluid composition

[0066] In some variations, the external fluid device can be connected to the connector to deliver the fluid composition to the delivery device. The external fluid device can include a syringe, a vial, or another container for storing fluid. The external fluid device can be provided as a part of the delivery system in the 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 can be packaged in a (for example) kit in which a fluid composition is arranged. In other variations, the external fluid device may not be pre-loaded, but may be packaged as empty and loaded with a fluid composition by the user before surgery. In these variations, the kit described herein may also include a separate fluid container (for example, a vial, a syringe), which includes a fluid used with the external fluid device described herein and / or a fluid delivery device. The external fluid device may include a volume marker. In some variations, the external fluid device may be partially or completely transparent or otherwise see-through to allow the user to easily distinguish the volume of the fluid composition in the external fluid device.

[0067] Fluid compositions may include fluid compositions, which include but are not limited to saline and viscoelastic fluids. Viscoelastic fluids may include hyaluronic acid, chondroitin sulfate, cellulose, their derivatives or mixtures, or their solutions. In some variations, viscoelastic fluids may include sodium hyaluronate. Additionally or alternatively, viscoelastic fluids may also include medicines. For example, viscoelastic fluids may include medicines suitable for treating glaucoma, reducing or lowering intraocular pressure, alleviating inflammation, fibrosis, new blood vessel formation or scarring, and / or preventing infection. For example, in some variations, viscoelastic fluids may include therapeutic agents as described herein, such as but not limited to Rho kinase (ROCK) inhibitors and agents for gene therapy, DNA, RNA, or stem cell-based methods. Fluid compositions may include customized pharmaceutical preparations.

[0068] Slender member

[0069] Figure 3 An exploded view of a variation of a delivery device is depicted. Some variations of the delivery devices described herein may include an elongated member (308) coaxially disposed within a cannula lumen (310). In some variations, the elongated member (308) may include a catheter 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 elongated member (308) may be solid without a lumen, but may still be configured to disrupt the trabecular meshwork or other similar tissue.

[0070] The elongated member (308) can be coaxially disposed and can slide within a cannula lumen (310) of a delivery system described herein. When the elongated member (308) is in a retracted position relative to the cannula (306), the distal end of the elongated member (308) can be located within (i.e., proximal to) the distal tip of the cannula (306). When the elongated member (308) is in an extended position relative to the cannula (306), the distal end of the elongated member (308) can be located outside (i.e., distal to) the distal tip of the cannula (306). The extended length of the elongated member (308) beyond the distal tip of the cannula (306) can correspond to the distance around Schlemm's canal that the elongated member (308) can pass through (e.g., in order to disrupt Schlemm's canal and / or surrounding trabecular canalicular tissue, and / or deliver a fluid composition). When the variations of the delivery systems described herein are used to deliver a fluid composition, the length through which the elongated member (308) passes can correspond to the length of the canal around which the fluid composition is delivered. When the variations of the delivery systems described herein are used to mechanically tear or cut the trabecular meshwork independently of fluid delivery, the length through which the elongated member (308) passes can correspond to the length of the trabecular meshwork that is cut or torn. In some variations, the length can be between about 1 mm and about 50 mm. In some variations of these variations, the length can be between about 10 mm and about 40 mm, between about 15 mm and about 25 mm, between about 16 mm and about 20 mm, between about 18 mm and about 20 mm, between about 19 mm and about 20 mm, between about 18 mm and about 22 mm, about 20 mm, between about 30 mm and about 50 mm, between about 35 mm and about 45 mm, between about 38 mm and about 40 mm, between about 39 mm and about 40 mm, or about 40 mm. Elongate member (308) may be moved between an extended position and a retracted position using a drive assembly of a delivery device, as described in greater detail herein.

[0071] The elongated member (308) can be sized so that it can be advanced through the cannula (306) and into a portion of Schlemm's canal (e.g., 0 to 360 degrees of the canal). In some cases, the outer diameter of the elongated member can be configured to disrupt trabecular meshwork canal tissue, stent, and / or apply tension to the canal, and / or deliver a fluid composition. The elongated member (308) can be made of any suitable material that imparts the desired flexibility and pushability for introducing the elongated member through the eye wall, approaching Schlemm's canal, and / or navigating through other ocular tissue structures. For example, the elongated member (308) can include a polymer; a polymer reinforced with a reinforcing member such as, for example, a wire, braid, or coil; a composite of a polymer and a metal; 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, without limitation, polycarbonate, polyetheretherketone (PEEK), polyethylene, polypropylene, polyimide, polyamide, polysulfone, polyether block amide (PEBAX), fluoropolymers, and nylon.

[0072] In order to facilitate access to Schlemm's canal, in some variations, it may be desirable to coat all or a portion of the elongated member (308) with a lubricious coating (e.g., a lubricious polymer coating) to reduce friction between the body of the elongated member (308) and the cannula and / or ocular tissue as the elongated 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. In some variations, additionally or alternatively, the elongated member (308) may be comprised of one or more materials having a lower coefficient of friction than the ocular tissue (e.g., tissue of Schlemm's canal) that the elongated member (308) contacts when used as intended, and / or having a lower coefficient of friction than the material of the cannula.

[0073] In variations in which the elongated member (308) is reusable, the elongated member (308) may be made of a sterilizable (e.g., via autoclaving) material, such as a heat-resistant metal (e.g., stainless steel, aluminum, titanium). The elongated member (308) may be straight, sufficiently flexible and pushable to pass through the annular Schlemm's canal, or may be preformed to have a radius of curvature of approximately 2 mm to 10 mm or approximately 6 mm (i.e., the approximate radius of curvature of Schlemm's canal in an adult) to more easily partially or completely encircle Schlemm's canal. In some variations, the elongated member (308) may be configured to be advanced over or along a guidewire.

[0074] 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, an illuminated beacon, optical fibers, side-illuminated optical fibers, luminescence, fluorescence, etc. may be used to improve visualization. For example, an optical fiber may be run 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 as the elongate member (308) is advanced or retracted around Schlemm's canal. In other words, in some variations, a portion of elongate member (308) (eg, a distal end, a central portion) may be illuminated or may otherwise include an illumination device to aid in visualizing movement of elongate member (308) within Schlemm's canal.

[0075] In some variations, the elongated member (308) may be sized to be advanced through Schlemm's canal in an atraumatic manner (e.g., without trabecular meshwork disruption). In other variations, the elongated member (308) may be sized to have an outer diameter sufficient to disrupt Schlemm's canal and surrounding trabecular meshwork canal tissue. The outer diameter may 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 elongated member to have an outer diameter of about 240 microns, although portions of the elongated member (e.g., the distal tip) may vary in size and shape.

[0076] In some variations, the distal end of the elongated member (308) may be configured as a curved tip, a compound curved tip, an atraumatic tip, an enlarged atraumatic tip, etc., to assist in advancing the elongated member (308) through Schlemm's canal. In some of these variations, the distal end may include a blunt parasol-shaped atraumatic tip. In other variations, the distal portion of the elongated member (308) may optionally include a disruptive component, such as a notch, a hook, a barb, a rough surface, or a combination thereof, to disrupt the proximal tubule portion of Schlemm's canal or the proximal tubule portion of the proximal trabecular network. One or more protrusions emanating from the elongated member (308) may further disrupt the proximal tubule portion of Schlemm's canal or the proximal tubule network, and thereby increase the permeability of aqueous humor through the trabecular meshwork into Schlemm's canal. In some cases, the elongated member (308) may also deliver energy to the trabecular meshwork tubule tissue (e.g., ultrasound energy, radiofrequency energy (e.g., for electrocautery, electroablation), electromagnetic radiation, light energy (e.g., via optical fiber)).

[0077] FIG. 14A to FIG. 14E Various variations of the distal end of the elongate member are depicted. FIG. 14A to FIG. 14E The variations depicted in can facilitate access to and advancement within Schlemm's canal or other ocular tissue. For example, FIG. 14A to FIG. 14E The configuration of the distal end of the elongated member depicted in FIG. 4 may help advance the distal end of the elongated member through an opening (e.g., an incision) formed in the trabecular meshwork to access Schlemm's canal, and / or may allow for easier advancement through Schlemm's canal once inserted into Schlemm's canal.

[0078] like Fig.14A As seen in FIG. 1 , the elongated member (1400A) may include a distal end (1402A) having a first length and an inner lumen opening (1406A) in fluid communication with an inner lumen (1420A) of the elongated member (1400A). The distal end (1402A) may have a constant outer diameter (1408A) along the first length, as shown in FIG. Fig.14A In some variations, the constant outer diameter (1408A) along the first length of the distal end portion (1400A) may be the same as the outer diameter of all or a portion of the remainder of the body of the elongated member (1402A), while in other variations, the outer diameter (1408A) of the distal end portion (1402A) of the elongated member (1400A) may be different than the outer diameter of different portions of the body of the elongated member (1400A). In some variations, the distal end portion (1402A) may include a rounded distal edge (1412A).

[0079] In some variations, the distal end of the elongated member may not have a constant outer diameter along the length of the distal end. Fig. 14BAs depicted, the distal end (1402B) may include a spherical shape such that the outer diameter of the distal end (1402B) varies along the length of the distal end. In some variations, the spherical shape may be at least partially spherical. The distal end (1402B) may include 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 elongated member (1400B). The intermediate outer diameter (1416B) may be greater 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 most distal portion of the distal end (1402B) of the elongated 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 elongated member (1400B) may also include a rounded distal edge.

[0080] In some variations, the distal end of the elongate member may include a taper that terminates in the lumen opening. Fig. 14C As shown, the distal end (1402C) of the slender member (1400C) can have a first outer diameter (1408C) in a first portion of the distal end (1402C) and a smaller second 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 slender member (1400C) can decrease linearly between the first portion and the second portion, so that the distal end (1402C) includes an inclined surface. The first outer diameter (1408C) can be the same or different (e.g., greater than or less than) than the outer diameter of the rest of the body of the slender body, while the second outer diameter (1410C) can be generally less than the outer diameter of the rest of the body of the slender body.

[0081] In some variations, the distal end may be constructed as a combination of the configurations previously described herein. For example, the distal end may include one or more bulbous portions, one or more tapered or inclined portions, and / or a rounded distal edge. For example, the distal end may include a proximal inclined portion, a central bulbous portion, and a distal inclined portion, wherein the slope of the proximal portion is opposite to the slope of the distal portion. In this way, 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 another variation, the distal end may include multiple inclined portions (e.g., two, three, four, five, or more) having different slopes. For example, Fig.14D An exemplary variation is depicted in which the distal end (1402D) includes multiple inclined portions. As shown, the distal end (1402D) can include a proximal inclined portion (1416D) having a positive slope, a central inclined portion (1418D) having a negative slope, and a distal inclined portion (1420D) having a negative slope different from the negative slope of the central portion (e.g., a greater negative slope). In this manner, the outer diameter of the distal end 1402D can change (e.g., linearly) from the proximal outer diameter (1408D) to the first central outer diameter (1410D), to the second central outer diameter (1412D), and finally to the distal outer diameter (1414D), as measured at the location where the slope changes. The first central outer diameter (1410D) can be greater than the proximal outer diameter (1408D), the second central outer diameter (1412D), and the distal outer diameter (1414D). The second center outer diameter (1412D) may be greater 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) may be approximately equal, while in other variations, the proximal outer diameter (1408D) may be greater than the distal outer diameter (1414D). While a center sloped portion having a negative slope is described above, it should be understood that in some variations, this portion may not have a negative slope and may instead have a constant outer diameter.

[0082] In some variations, such as Fig.14EAs seen in , the distal end (1402E) of the elongated member (1400E) may include a rounded distal end (1403E). In addition, the distal end (1402E) including the rounded distal end (1403E) may facilitate 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) in fluid communication with the lumen of the elongated member (1400E). In some variations, the distal end may include both a central lumen opening and one or more offset or side openings on the distal-most surface, each of which may be in fluid communication with the lumen of the elongated member (1400E). In some variations, the one or more offset or side openings (1426E) may include a single offset or side opening, or a plurality of 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, may be offset along the circumference of the distal end (e.g., alternately positioned above and below the circumference), may be positioned in multiple rings around the distal end, may be randomly positioned on the distal end, or may have any other configuration suitable for fluid delivery. Each of the offset or side openings may be substantially the same size (e.g., comprising the same diameter) or may be a different size (e.g., one or more 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, one or more offsets or side openings (1426E) may direct the fluid composition exiting the lumen of the elongate member in the direction of the trabecular meshwork and / or in an opposite direction toward a collecting channel.

[0083] Re-reference Figure 3 As described above, the elongated member (308) may include a catheter including a lumen. The elongated member (308) may be configured to deliver a fluid composition. The fluid composition may travel through the lumen of the elongated member (308) and may be delivered through one or more openings of the lumen. The fluid composition may be used to disrupt the trabecular meshwork and other surrounding tissue.

[0084] In some variations, the distal end of the elongated member (308) may be constructed or modified to facilitate delivery of the fluid composition into Schlemm's canal. For example, the distal end of the elongated member (308) may include a cutout configured as a half-tube. In addition to or in lieu of the opening at the distal tip, the elongated member (308) may optionally include a plurality of openings through its body (e.g., sidewall) that are spaced apart along the axial length of the elongated member (308). In this variation, the fluid composition may be delivered from the reservoir through the opening in the elongated member into Schlemm's canal. Such lateral injection of the fluid composition (e.g., viscoelastic fluid) may, in some cases, enhance the destruction of the outflowing tissue and enhance the permeability to the aqueous humor. It should be understood that the openings may have any suitable number, size, and shape and may be spaced apart along the axial length of the elongated member (including the distal tip) in any suitable manner.

[0085] Drive components

[0086] The delivery device (300) can generally include a drive assembly (320) configured to move the elongated member (308) (e.g., a catheter) and / or deliver the fluid composition into Schlemm's canal. The drive assembly (320) can be at least partially contained within the housing (304) and can include any suitable component or combination of components that can provide the general functionality of the handle (302), such as Figure 3 Depicted.

[0087] The drive assembly can 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 can cause a slidable elongated member (308) (e.g., a slidable catheter) to extend distally out of the cannula (306), and / or it can cause the slidable elongated member (308) to retract proximally into the cannula (306). The drive assembly (320) can also optionally cause a fluid composition to be delivered from a fluid reservoir (332) through the elongated member (308) and / or the cannula (306).

[0088] Each of these effects (i.e., extension of the slidable elongated member (308), retraction of the slidable elongated member (308), and / or delivery of a 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 precise 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 elongated member (308), and rotating the rotatable element in an opposite second direction can cause retraction of the slidable elongated member (308). When the delivery system is configured to deliver a fluid composition, rotating the rotatable element (e.g., in the first direction and / or the second direction) can also cause delivery of the fluid composition. Delivery of the fluid composition can be performed simultaneously with movement (e.g., advancement and / or retraction) of the slidable elongated member (308). In some of these cases, the fluid composition can be delivered to a portion of Schlemm's canal in which the slidable elongated member (308) is advanced. That is, the fluid composition can be delivered to the same arc length of Schlemm's canal as the extension of the elongated member (308). When the delivery of the fluid composition is performed simultaneously with the retraction of the elongated member (308), the fluid composition can replace the position of the slidable elongated member when the slidable elongated member (308) is retracted, and can expand the Schlemm's canal and / or the collection channel and / or near tubule network at this position in the Schlemm's canal. In addition, the amount of the delivered fluid composition can depend on the amount of movement of the elongated member (308). That is, a predetermined fixed volume of the fluid composition can be delivered (e.g., delivered out of the distal end of the elongated member (308)) via the elongated member (308) for a fixed amount of movement of the elongated member (308) (e.g., the retraction distance) and for a fixed amount of rotation of the rotatable element.

[0089] In other variations, the amount of fluid composition delivered may not depend on the amount of movement of the elongated member. In other words, the amount of fluid composition delivered may be independent of the amount of movement of the elongated member. Therefore, it can be understood that there may be two separate actuators for movement of the elongated member (308) and delivery of the fluid composition. For example, a first actuator may be configured to advance and / or retract the elongated member (308), and a second actuator may be configured to deliver the fluid composition. If the first actuator includes a rotatable element (e.g., one or more wheels (350)), rotating the rotatable element in a first direction may cause advancement of the slidable elongated member (308), and rotating the rotatable element in an opposite second direction may cause retraction of the slidable elongated member (308). When the delivery system is configured to deliver the fluid composition, the second actuator may be engaged to cause delivery of the fluid composition. The second actuator may include a slidable or translatable element (e.g., a slider), a rotatable element, a depressible element (e.g., a button), a lever, etc. (with or without mechanical advantages or mechanical disadvantages). It should be understood that although the aforementioned actuators are described as rotatable, slidable or translatable and depressible elements, any suitable actuator may be utilized, and any of these actuators may be used to cause advancement and / or retraction of the elongated member, and / or delivery of the fluid composition (e.g., the first actuator may be any of a slide, a button, a rotatable element, etc., and the second actuator may be any of a slide, a button, a rotatable element, etc.).

[0090] 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, for example, the slidable elongate member (308) from being advanced again after 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, advanced again, and retracted again by an unlimited amount and number of times. Exemplary mechanisms that may convert external inputs into movement of one or more components of a delivery system are described in greater detail herein.

[0091] In some variations, the drive assembly (320) may include a component that converts rotational motion into linear motion. For example, the drive assembly (320) may include a linear gear and a pair of pinions. Each pinion may also be coupled to a rotatable component (350) (e.g., a wheel). In some variations, this coupling may be achieved by a pin and a nut that may pass through a central opening in the rotatable component and the pinion, the nut securing the rotatable component and the pinion in such a way that rotation of the rotatable component also rotates the pinion and vice versa. In some variations, the wheel may be attached to the pinion by one of the following methods: 1) the wheel and the pinion are molded as one component using injection molding techniques; 2) the wheel is slid onto the pinion and secured with an adhesive; or 3) the wheel is slid onto the pinion and mechanically secured with a fastener or "press fit", where the wheel is pressed onto the pinion and friction holds them securely. The wheel and the pinion may rotate coaxially in the same direction and at the same angular velocity. In some variations, the wheel may have markings or colors to indicate the degree of advancement and / or the direction of advancement.

[0092] One variation of a drive assembly (320) may include linear gears, a pair of pinion gears, and at least one rotatable component coupled to each pinion gear. In other variations, the drive assembly may include linear gears, a single pinion gear, and a single rotatable component coupled to the pinion gear. In variations having a pair of pinion gears, the pinion gears and associated wheels may be disposed on either side of the linear gears. In some variations, the pinion gears and the linear gears may contact each other, i.e., the teeth of the pinion gears may directly engage corresponding teeth on the linear gears, and the wheels on one side of the linear gears may contact the wheels on the opposite side of the linear gears. In other variations, the pinion gears and the linear gears may be indirectly coupled, for example via one or more idler gears.

[0093] At least a portion of the wheel (350) on one side of the linear gear may extend outside of the housing (304) for manipulation by a user. The drive assembly (320) may be manipulated with one hand when in a first configuration, and then manipulated with the same hand or another hand when flipped to a second configuration. A drive assembly (320) having such flexible capabilities may be easily used by right-handed or left-handed persons, and may also be used in surgeries in which the handle is flipped during surgery so that the sleeve (306) faces a first direction in a first portion of the surgery and faces a second direction in a second portion of the surgery. In another variation, the drive assembly (320) may include a rotatable component on one side of the handle (302) and a "universal" feature of the handle (302) provided by the sleeve (306) that itself may rotate rather than flipping the handle (302). When the wheel and the pinion rotate coaxially in the same direction, and when there is no idle gear or an even number of idle gears (e.g., two) between the pinion and the linear gear, distal rotation of the portion of the wheel extending out of the housing can cause proximal translation of the linear gear within the housing (304), and conversely, proximal rotation of the portion of the wheel extending out of the housing (304) can cause distal translation of the linear gear within the housing (304). When the wheel and the pinion rotate coaxially in the same direction, and when there is an odd number of idle gears (e.g., one) between the pinion and the linear gear within the housing, distal rotation of the portion of the wheel extending out of the housing (304) can cause distal movement of the linear gear within the housing (304), and conversely, proximal rotation of the portion of the wheel extending out of the housing (304) can cause proximal movement of the linear gear within the housing (304).

[0094] The drive assembly may also include one or more features to stabilize the pinions or otherwise hold them in place. For example, in some variations, the drive assembly may include a wheel spacer configured to be located between the shafts of the pinions.

[0095] In other variations, a rotating gear (i.e., a pinion or idler gear) that interfaces with the linear gear may be capable of disengaging from the linear gear by biasing its position away from the linear gear. This action disengages the rotating gear teeth from the linear gear teeth to prevent the linear gear from moving as the wheel rotates. The drive assembly may also be capable of being locked from rotation by engaging a cross pin or feature that prevents the wheel from rotating.

[0096] Further modification of drive assembly may not adopt the conversion of rotational motion to linear motion.For example, the slide on the handle (for example, finger slide) can be fixedly or removably connected to the gear (for example, linear gear as previously described) in the housing of the handle.Here, drive assembly can be configured so that the advancement or retraction of slide causes the advancement or retraction of elongated member and / or the delivery of fluid composition to Schlemm's canal.In some modifications, the advancement or retraction of slide can cause the advancement or retraction of elongated member, while the delivery of fluid composition to Schlemm's canal can be actuated by a separate mechanism.In further modification, a button that can be pressed or squeezed can be adopted to replace slide, or a foot switch can be adopted to deliver fluid composition, advance elongated member and / or retract.In some modifications, the advancement or retraction of elongated member can be actuated by a separate mechanism, and a button that can be pressed or squeezed can be adopted to deliver fluid composition to Schlemm's canal.

[0097] Fluid components

[0098] like Figure 3 As depicted, some variations of the delivery device (300) may include a fluid assembly (330) comprising one or more of: a fluid reservoir (332) in fluid communication with the elongated member (308) and the cannula (306), a sealing member (336), and a connector (340). The fluid assembly (330) may be at least partially contained within a 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 included within the housing (314) of the handle (304), and a portion may extend (e.g., proximally, laterally) beyond or outside of the housing (314) of the handle (304).

[0099] Connectors

[0100] The connector (340) can be configured to be releasably or detachably coupled to the fluid reservoir (330). The proximal region of the connector (340) can be configured to receive the end of an external fluid device to deliver the fluid composition to the fluid reservoir (332). Advantageously, the connector (340) can be removable from the handle housing, thereby simplifying and streamlining the delivery of fluid to the fluid reservoir (332). In some variations, the connector (340) can be configured to couple with the coupling hub (334) at the proximal region of the fluid reservoir (332). In some variations, the fluid assembly (330) can also include a sealing member (336) and a plug (338). In variations in which the connector is removable, the sealing member (336) can be configured to seal the fluid reservoir (332). The plug (338) can be configured to guide the fluid composition from the connector (340) into the fluid reservoir (332), as will be described in more detail herein.

[0101] Figure 4A Variations of a connector (400) are shown. As shown, the connector (400) may include a connector body (401) having a proximal portion (402) with a proximal lumen opening (404), a distal portion (403) with a distal lumen opening (406), and a connector lumen (408) between the proximal lumen opening (404) and the distal lumen opening (406) and fluidly coupling the proximal lumen opening and the distal lumen opening. The connector (400) may also 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, 403)) and positioned between the proximal and distal portions (402, 403). When the connector (400) includes two or more tabs (410), the first tab may extend in a direction opposite to the second tab, such as Figure 4AAs shown. One or more tabs (410) can be configured to be engaged by a user to grasp the connector (400) and easily disengage the connector (400) from the housing of the handle for removal. In some variations, the proximal portion (402), and in particular the proximal lumen opening (404), can be configured to receive an end of an external fluid device therein to deliver a fluid composition to a fluid reservoir through the connector (400). In other variations, the external fluid device can receive a portion of the connector, such as a portion of the proximal portion (402) (e.g., an external fluid delivery device can fit over the proximal portion (402) and / or the proximal lumen opening (404)). The distal lumen opening (406) can define a distal lumen wall (416) that is configured to engage a coupling hub within the proximal lumen of the handle. Distal lumen wall (416) of connector (400) may be configured to engage the coupling hub in any suitable manner, such as, for example, using threads, a press fit, a snap fit, a bayonet, an interference fit, or the like.

[0102] like Figure 4B As shown, the distal cavity wall (416) may include one or more threads (412) configured to threadably engage corresponding threads of the coupling hub. The connector body (402) may include one or more extensions (414) configured to extend when the connector (400) is coupled to the proximal opening of the handle (see Fig. 6A ), one or more abutments (654A / 654B) of the proximal end of the engaging handle are engaged to prevent rotational movement of the connector (400) (see Figure 6C ). One or more extensions (414) can extend from the distal portion (403) and can include a flat surface (415) and a curved surface (417). In some variations, the flat surface (415) can extend a maximum distance from the distal portion (403) and the curved surface (417) can taper to a minimum distance from the distal portion (403). When the connector (400) is rotated in a first direction, the flat surface (415) can physically contact the one or more abutments (654A / 654B). In the example Figure 4B In the depicted variation including two or more extensions (414), the two or more extensions (414) may be oriented approximately 180 degrees apart. Figure 6B ) that engage with one or more extensions (414), which can properly orient the connector (400) within the proximal cavity of the handle. In some variations, the one or more abutments (see Figure 6C) can prevent a user from irreversibly securing the connector (400) to the connector hub of the handle (e.g., over-tightening, cross-threading, etc.). In some variations, the connector body (402) can also include a collar (418). The collar (418) can be configured as a stopper to prevent the connector (400) from being advanced too deep into the proximal cavity of the handle. In other words, the collar (418) can be configured to allow the connector (400) to be inserted into the proximal cavity of the handle to an appropriate depth. If the connector (400) is not inserted into the proximal cavity of the handle to an appropriate depth, proper fluid communication may not occur between the connector and the fluid reservoir, potentially causing fluid to pool within the connector and introduce air into the fluid assembly. When the connector (400) is coupled to the coupling hub of the handle, the connector lumen (408) can be aligned with the plug lumen (see Figure 6C ) to allow fluid to flow from the proximal lumen opening (404) of connector (400) into the fluid reservoir in a consistent and timely manner. In some variations, connector (400) may be pre-coupled to the handle, while in other variations, connector (400) may be detachable from the handle, allowing the user to couple connector (400) to the handle at their convenience.

[0103] Handle

[0104] The delivery system described herein may include a delivery device including a handle that can be used by a single operator with one hand. The handle may be configured to enable the ability to use the delivery system to be independent of which hand the user chooses to use or on which eye to perform surgery. For example, the handle may be configured to be used for the left hand and the right hand and for the left eye and the right eye. The handle may also be configured to enable the ability to use the delivery system to be independent of the direction in which the tool and / or fluid composition are delivered around Schlemm's canal. For example, the delivery system may be used to deliver the fluid composition in a clockwise direction in the eye, and then by simply rotating the handle (or in another variation by rotating the sleeve itself 180 degrees) to a second orientation, it may be used to deliver the fluid composition in a counterclockwise direction. However, it should be understood that in other variations, the delivery system described herein may be configured to be used in a specific configuration (e.g., one-sidedly upward, only in a clockwise direction, only in a counterclockwise direction, etc.).

[0105] Reference Figure 3The handle generally includes a housing having a proximal portion including a proximal end and a distal portion including a distal end and a gripping portion proximal to the distal end. The proximal portion can generally be configured to include or at least partially include a component (e.g., a reservoir) of a fluid assembly. The distal portion, and more specifically, the gripping portion can generally be configured to be held by a user when positioning the cannula (e.g., advancing the cannula through the anterior chamber, piercing the trabecular meshwork, advancing the cannula into Schlemm's canal), actuating the elongated member, and / or delivering a fluid composition. The proximal portion and the distal portion of the housing can each generally include an internal cavity, which can include (or at least partially include) internal components of the device, such as components of a drive assembly and a fluid assembly. The distal portion (e.g., the internal cavity of the distal portion) can include or at least partially include components of the drive assembly and can accommodate an internal portion of the cannula. It should be understood that one or more components of the drive assembly and / or fluid reservoir can be configured to translate, and thus can move between the proximal portion of the housing and the internal cavity of the distal portion. In some variations, the distal portion (e.g., distal end) of the housing can include a fluid port that can be configured to provide fluid for flushing the surgical field and / or clearing air from the system. The distal end of the housing can have a sleeve connected to it. The gripping portion of the distal portion can be raised, recessed, and / or grooved in certain areas, or otherwise textured to improve the user's grip on the handle, increase the ergonomic fit of the handle to the user's hand and control the orientation of the handle without the need for wrist rotation, and / or improve user comfort. The gripping portion can be configured to allow the user to grip the handle close to or adjacent to the sleeve (e.g., within about 3 inches or less), while still allowing the user to actuate the elongated member and / or deliver the 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 approximately 0.1 inches to 3 inches from the proximal end of the cannula. For example, the gripping portion may be configured to allow a user to grasp the handle within approximately 3 inches, within approximately 2.5 inches, within approximately 2 inches, within approximately 1.5 inches, within approximately 1 inch, within approximately .75 inches, within approximately 0.5 inches, or within approximately 0.25 inches from the proximal end of the cannula. In some variations, the gripping portion may be configured to allow a user to grasp the handle within approximately 0.25 inches to 2 inches from the proximal end of the cannula. In some variations, the gripping portion may be configured to allow a user to grasp the handle within approximately 0.25 inches to 1.5 inches from the proximal end of the cannula. The proximal portion (e.g., the proximal end) may have a connector removably coupled thereto, such as Figure 4A and Figure 4B The connector (400) depicted in FIG. 4A and 4B may be configured to releasably couple to an external fluidic device to transfer a fluid composition from the external fluidic device to the fluid reservoir.

[0106] The handle or portion thereof (e.g., the gripping portion) may be made of or may include any suitable material, including without limitation fluoropolymers; thermoplastics such as polyetheretherketone, polyethylene, polyethylene terephthalate, polyurethane (or as a thermoset), nylon, etc.; or silicone. In some variations, the housing or portion thereof may be made of or may include a transparent material. Materials having suitable transparency 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). Particularly useful acrylic copolymers include, but are not limited to, polymethyl methacrylate (PMMA) copolymers and styrene methyl methacrylate (SMMA) copolymers (e.g., Zylar 631 ® In variations where the universal handle is reusable, the handle may be made of a sterilizable (e.g., via autoclave) material such as a heat-resistant metal (e.g., stainless steel, aluminum, titanium) or a high-performance engineering polymer such as PEI, PEEK, or PEKK.

[0107] The length of the universal handle may generally be between about 1 inch (2.5 cm) and about 20 inches (50.8 cm). In some variations, the length of the universal handle may be between about 4 inches (10.2 cm) and 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 the universal handle from the distal end to the proximal end of the handle may 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).

[0108] The handle can be configured to fit in the hand in an ergonomic manner for dexterous use. To this end, one or more of the proximal portion and the distal portion 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). This configuration can make it easier for the user to rotate the handle (e.g., about 10 degrees to about 180 degrees or more) around the longitudinal axis of the handle during use. In some variations, this configuration can make it easier for the user to rotate the handle about 15 degrees to about 30 degrees, including about 20 degrees, around the longitudinal axis of the handle during the use of the device (e.g., during each hemisphere of Schlemm's canal when the fluid composition is delivered). In some variations, all parts 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 portion and the proximal portion 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 portion and the proximal portion 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 symmetrical nature of a portion of the shell may refer only to the shape of the profile of the portion (e.g., the outer surface), and may or may not include the inner surface of the shell (i.e., the profile of a portion of the shell may be symmetrical across a plane, while the inner surface may include different pins, extensions, or other structures configured to interact or engage with internal components of the device).

[0109] Distal portion of the handle

[0110] Reference Figure 2, the handle (200) may include a housing (206) that also includes a proximal portion (202) and a distal portion (201). In some variations, the distal portion (201) may include a gripping portion (204). The gripping portion (204) may include a first curved side and a second curved side opposite the first curved side, as will be described in more detail herein. In some variations, the gripping portion (204) may include one or more actuators (210), wherein the one or more actuators (210) may be configured to move the elongated member (234) and / or deliver fluid. The gripping portion (204) may also include a tapered region that is configured to receive a user's finger. The tapered region may be distal to the one or more actuators (210) and / or the first curved side and the second curved side. In some variations, grip portion (204) may be commensurate in length with distal portion (201), while in other variations, grip portion (204) may be a segment or portion of distal portion (201) such that the length of grip portion (204) is less than the length of distal portion (201). For example, in some variations, the grip portion and distal portion may have the same proximal end, while the distal end of the grip 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 grip portion.

[0111] In some variations, the grip portion (204) may also include one or more flat areas (240) (e.g., two, three, four, or more). The flat area (204) may be configured to receive a portion of a user's hand during surgery (e.g., may be configured as a finger rest). In some variations, the one or more flat areas (240) may be proximal to the one or more actuators (210). The one or more flat areas (240) may include 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 planar area and a second planar area, the first planar area including a first planar surface and the second planar area including a second planar surface, as will be described in more detail herein. The one or more planar areas may have any suitable size and shape. For example, in some variations, each of the one or more planar areas may be positioned to span a majority of the width of a top surface or a bottom surface of the housing of the handle, such that a majority of the top surface or the bottom surface is planar. In some variations, one or more flat areas may be positioned to span about 50% to about 100% of the width of the top or bottom surface. For example, in some variations, one or more flat areas may be positioned to span 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 areas may have a maximum width of about 50% to about 100% of the center width of the handle at a position aligned with the maximum width of the flat area. Each of the one or more flat areas may have a maximum width of 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 position aligned with the maximum width of the flat area.

[0112] Typically, the length of the gripping portion can be equal to the total length of the distal portion, or can be less than the total 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.

[0113] In some variations, the grip portion (204) may include an anti-slip material. The anti-slip material may extend beyond the one or more actuators and may terminate adjacent to the distal end of the handle. In some variations, the grip portion (204) may include an anti-slip material on the tapered portion. For example, the anti-slip material may surround a portion (e.g., a majority) or all of the tapered portion. The anti-slip material may circumferentially surround all or a portion of the tapered portion.

[0114] Typically, each of the proximal portion and the distal portion can have a length along the longitudinal axis, and the total length of the handle can be the sum of the lengths of the proximal portion and the distal portion. 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 than 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 total 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, 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.

[0115] In some variations, the proximal portion may have a length within a range of about 2 inches to about 7 inches, and / or the distal portion may have a length within a 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 a 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 a range of about 3 inches to about 6 inches (including about 4 inches to about 5 inches).

[0116] Along the length of the handle, the proximal portion may have a first diameter, and the distal portion may have a second diameter that is 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 maximum diameter) of the proximal portion may be greater than the second diameter (e.g., the maximum diameter) of the distal portion, or the second diameter (e.g., the diameter at the proximal end of the distal portion) of the distal portion may be greater than the diameter (e.g., the diameter at the proximal end of the proximal portion) of the proximal portion.

[0117] Figure 5A A delivery device (500) is depicted that includes a handle (502) that includes a housing (504) having 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) that is configured to be received in a user's hand, or otherwise grasped or held during use of the device, and more specifically, grasped or held when advancing the device to Schlemm's canal, approaching Schlemm's canal with a cannula, actuating an elongated member, and / or delivering a fluid composition. Although the user may grasp any location on the handle (502), including during transfer of the fluid composition into a fluid reservoir, the gripping portion (506) may be particularly configured to receive a user's hand (e.g., a finger) when approaching Schlemm's canal and / or during delivery of the fluid composition to the eye, and may provide convenient access to one or more actuators during surgery. The grip portion (506) may be commensurate in length with the distal portion of the handle (502) or may form a portion or segment of the distal portion. In some variations, the grip portion (506) may be configured to enable a user's hand to be positioned forward relative to the patient while the proximal portion (503) may rest in a recess between the user's thumb and index finger. Typically, the handle is designed to enable a user to securely grasp the grip portion proximal to the cannula, wherein the proximal cannula includes distal to one or more actuators. In some variations, the grip portion (506) may taper toward the cannula to form an elongated nose that may further allow precise control of the distal portion by providing a surface that easily and comfortably allows the user's fingers to be placed. In addition, the grip portion (506) is configured to facilitate the user's grasping and manipulation of the device proximal to the cannula, which may optimize the user's control of the cannula during use (e.g., when approaching Schlemm's canal). The position and shape of the gripping portion (506) may also bring the user's hand closer to the patient, which may improve stability and control of the device. In addition, the handle, and in particular the gripping portion (506) of the handle, may be configured to provide a contact point for guidance and control, as described above, while also allowing the user to access one or more actuators of the device without repositioning the hand.

[0118] As described above, generally, the handle can be configured so that a user can grasp the handle at the gripping portion and still easily access one or more actuators that can be used to actuate the elongated member and / or deliver the fluid composition to Schlemm's canal. Figure 5A As depicted, the one or more actuators may include two actuators (550A / 550B), a first actuator (550A) on the top side and a second actuator (550B) on the bottom side.

[0119] In some variations, the device can be configured such that a user can grasp the handle at the gripping portion (506) to deliver the fluid composition in a clockwise direction in 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 in the eye. In some variations, as described above, the gripping portion (506) can include one or more flat regions proximal to the one or more actuators (550A / 550B). Each of the one or more flat regions can include a planar surface, such as Figure 5A In some variations, grip portion (506) may include a first flat region (542A) that also includes a first planar surface on the top of the handle (eg, Figure 5A ). The gripping portion (506) may also include a second flat region (542B) that also includes a second planar surface on the top of the handle. In some variations where the gripping portion includes 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.

[0120] The gripping portion (506) of the handle can be configured to be non-slip and / or at least partially compressible relative to the rest of the handle. For example, the gripping portion (506) can have properties that make it easier to hold relative to the rest of the handle, such as, for example, including a material having a higher coefficient of friction and / or a lower hardness than the rest of the shell of the handle (e.g., the proximal portion, the proximal end of the distal portion). The gripping portion (506) can include a variety of materials, including, for example, a material having the above-mentioned properties that is coated on or otherwise covers the material forming the rest of the shell. For example, in some variations, the shell can be formed of a first material such as ABS or PC, and the gripping portion can also include a second material such as an elastomer (e.g., rubber) coupled to the first material (e.g., its outer surface). In some variations, the proximal portion (503) can be formed of a first material, the distal portion (505) can be formed of a second material different from the first material, and the gripping portion (506) can be formed of a third material different from the first and second materials. In some variations, increased friction between grip portion (506) and the user's hand due to the grip portion material having a higher coefficient of friction than the rest of the handle material allows the user to maintain control of the device and / or orient the device without causing the device to slip out of the user's hand.

[0121] In some variations, the grip portion (506) or a portion thereof may include a textured surface (508) configured to help a user maintain contact with and manipulate the handle (502). The textured surface (508) may overlie the grip portion (506) and be made of a different material than the grip 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, impressions, engravings, etc.) or a combination thereof. For example, the raised elements may include ridges and / or the recessed elements may include circular depressions. Each raised element or recessed element may be the same size or different sizes (e.g., cross-sectional area, diameter, etc.). Each raised element or recessed element 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 constant pattern across the grip 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 one embodiment, the textured surface (508) may have protrusions having a first height closer to the one or more actuators (550) to assist the user in rotating the grip portion (506), while the textured surface (508) may have protrusions having a different second 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 that have a larger cross-sectional area when closer to the one or more actuators (550) to increase the tactile feel when closer to the one or more actuators (550), while the depressions further away from the one or more actuators (550) have a small cross-sectional area.

[0122] Each of the top surface (510) and the bottom surface (513) may include features that help a user identify the location of one or more actuators of the device via 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 made of a different material than the gripping portion (506) or may be made of the same material as the gripping portion (506). In some variations, the actuator boundaries (511, 513) may include recessed elements or raised elements, thereby allowing a user to clearly identify the boundaries of the actuator boundaries (511, 513) and the actuators (550A, 550B) by touch. In some variations, one or more of the actuator boundaries (e.g., two actuator boundaries) may be continuous with the planar surface of the corresponding flat area.

[0123] The grip portion (506) may be shaped in a manner to fit ergonomically into the hand of a user. To this end, in some variations, the grip portion (506) may be symmetrical across the YZ plane, such as Figure 5B Depicted. 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 grip portion and the second grip portion (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 grip portion (506A) may include a first curved side, and the second grip portion (506B) may include a second curved side. In some variations, the first grip portion and the second grip portion (e.g., the first curved side and the second curved side) may be symmetrical across the cannula. In some variations, the first grip portion (506A) and the second grip portion (506B) may be symmetrical across the XZ plane. In some variations, a portion of each of the first and second curved sides 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.

[0124] 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) can each be convex or include a convex curve. In some variations, the convex curves of the first gripping portion (506A) and the second gripping portion (506B) can 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 curves of the first gripping portion (506A) and the second gripping portion (506B) can include a range of about 3 / 8 inches to about 1.5 inches, about ½ inches to about 1.5 inches, about ¾ inches 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 curves of the first gripping portion (506A) and the second gripping portion (506B) can include a range of about 0.3 inches to about 1 inch, about 3 / 8 inches to about ¾ inches, 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 a range 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 inches, about 0.3 inches to about ¾ inches, about 0.3 inches to about ½ inches, and about 0.3 inches to about 3 / 8 inches. In some variations, the first gripping portion (506A) may have a first arc (e.g., a convex arc) with a first center, the second gripping portion (506B) may have a second arc (e.g., a convex arc) with a second center, and the first center and the second center may be on opposite sides of the central longitudinal axis of the cannula and / or the central longitudinal axis of the handle, such as Figure 5B . In some variations, utilizing a convex first and second grip portions (506A, 506B) can allow a user to reorient or slightly rotate the grip portions between the thumb and one or more opposing fingers, rather than using the wrist to reorient or rotate the entire handle. This provides an ergonomic benefit to the user and can help reduce arm fatigue. In addition, slight rotational movement of the first and second grip portions (506A, 506B) can translate into movement of the distal tip. For example, in some variations, the first and second grip portions (506A, 506B) can allow the orientation of the grip to be limited to approximately + / - 30 degrees around the central longitudinal axis by only the user, without the user having to rotate at the wrist.

[0125] The first grip portion and the second grip portion (506A, 506B) (e.g., the first curved side and the second curved side) can each have one or more radii of curvature between the top surface and the bottom surface (510A, 512A). For example, the first grip portion and the second grip portion (506A, 506B) can each include a first smaller radius of curvature near or adjacent to the top surface (510A / 512A) and a second larger radius of curvature between (e.g., in between) the top surface and the bottom surface (510A / 512A), thereby allowing the grip portion (506) to fit ergonomically into the user's hand, contacting the user's hand at or along multiple points to increase control of the device. In some variations, one or more of the first grip portion and the second grip portion (506A / 506B) can each include a faceted surface (e.g., a polygon including two or more faces) from the first top surface (510) to the second bottom surface (512) opposite the top surface (510). In some variations, the faceted surfaces may collectively include a curve having a radius of curvature within the range of radii of curvature described herein. The faceted surfaces of one or more of the first grip portion and the second grip portion (506A / 506B) may be configured to control the rotation angle of the grip portion in the hand of the user. It should be understood that although described in the previous two paragraphs with respect to the first grip portion and the second grip portion (506A, 506B), such features are also applicable to the first curved side and the second curved side that may form the first grip portion and the second grip portion, respectively, in some variations.

[0126] like Figure 5B As shown, each of the actuators (550A / 550B) can be positioned on or otherwise extend from the top and / or bottom surfaces (510A, 512A) of the gripping portion. The actuators (550A / 550B) can extend a defined distance from the top and bottom surfaces (510A / 512A) and / or can have different shapes so that when a user is manipulating the gripping portion (506), the actuators (550A / 550B) can be easily distinguished from each of the surfaces (510A / 512A) themselves. The top and bottom surfaces (510A / 512A) may be substantially flat or may otherwise have a large radius of curvature relative to other portions of the handle (e.g., gripping portion, neck, proximal portion), thereby allowing a user to easily rest a finger on the top and bottom surfaces (510A / 512A) and place the finger close to the actuator (550A / 550B) but not on the actuator. Figure 5C, the top surface may include a first flat area (544A), and the bottom surface may include a second flat area (544B). The user may rest one or more fingers on each of the first flat area (544A) and / or the second flat area (544B).

[0127] When designing the handle (502) to have enhanced ergonomic features, the gripping portion (506) may be symmetrical across an XZ plane parallel to the longitudinal midpoint (570), such as Figure 5C The symmetry of the gripping portion (506) across the XZ plane allows a user to grip the top surface (510) in substantially the same orientation as the bottom surface (512). In addition, the symmetry of the gripping portion (506) allows a user to prefer using the first actuator (550A), the second actuator (550B), or both to actuate the elongated member and / or deliver the fluid composition.

[0128] When a user's thumb or finger contacts the top surface (510) or the first actuator (550A) or the bottom surface (512) or the second actuator (550B) (e.g., including one or more flat areas (544A / 544B)), the textured surface (508) of the gripping portion (506) can contact multiple locations on the user's hand to stabilize the delivery device (500) during delivery of the fluid composition to the eye.

[0129] The gripping portion (506) may have an hourglass shape, such as Figure 5C As shown. The grip portion (506) can taper from the top surface (510A) to the distal end (542) of the grip portion (506). The grip portion (506) can have a maximum height (562A) at a location along the longitudinal axis having the first actuator (550A) and the second actuator (550B). The grip portion (506) can have a minimum height (564A) at the distal end (542). The taper of the grip portion (506) from the maximum height (562A) to the minimum height (564A) can provide the grip portion (506) with a compact feel in the hand of the user, thereby allowing the user to easily rotate the handle (502) about the longitudinal axis to rotate the cannula as desired. Aligning the actuators (550A / 550B) with the portion of the grip portion having the maximum height (562A) can allow for maximum spacing between the two actuators (550A / 550B), thereby 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) can be aligned with at least a portion of the actuators (550A / 550B). For example, in one embodiment, the maximum height (562A) can be aligned with the midpoint of each of the actuators (550A / 550B).

[0130] The height of the gripping portion (506) may vary (e.g., decrease) proximally from a maximum height (562A) at the one or more actuators (550A / 550B) to a smaller height (566A) at the neck (540) positioned proximal to the one or more actuators (550A / 550B). In some variations, the rate of change from the maximum height (562A) at the 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 the 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 a height of about 0.8 inches to about 2.0 inches. For example, in some variations, the maximum height (562A) may 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) may be about 0.2 inches to about 0.8 inches in height. For example, in some variations, the height (566A) of the neck (540) may 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) may 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 height (566A) of the neck 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 the height (566A) of the neck to the minimum height (564A) may 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.

[0131] 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 and the second curved surface (582B) may be convex. The second curved surface (582B) may include an actuator (550B). In the case where the gripping portion (506) is symmetrical across the XZ plane, it can be understood that the top surface (510) may include corresponding curved surfaces and straight surfaces. The straight surface (584B) may be distal to the second curved surface (582B), and the straight surface (584B) may taper along the longitudinal axis until the distal end (542).

[0132] In some variations, the grip portion (506) may include different cross-sectional shapes along the longitudinal axis of the handle. For example, proximally, the grip portion (506) may include a circular cross-sectional shape having a first diameter, while a central portion of the grip portion (506) including the top and bottom surfaces (510A / 512A) and the actuator (550A / 550B) may include a rectangular or elliptical cross-sectional shape having a major axis and a minor axis, and a distal portion (including the distal end) of the grip portion (506) may include a circular cross-sectional shape having a second diameter. The major axis and the minor axis may increase distally from the proximal portion of the grip portion (506) including the circular cross-sectional shape to a maximum major axis and a maximum minor axis, which may be aligned with the location of the actuator (550A / 550B), and may then decrease distally until the distal portion of the grip portion (506) includes a circular cross-sectional shape having the second diameter. In some variations, the first diameter can be greater than the second diameter, and the maximum major axis can be greater than both the first diameter and the second diameter. In some variations, the major axis can be at least about 1.5 times to at least about 3 times the minor axis. In some variations, the major axis can 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 can 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 can be greater 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 can provide additional beneficial effects. For example, in some variations, the smaller the diameter of the handle, the greater the degree of rotation that can occur per movement, especially at the distal end.

[0133] As described above, in some variations, the gripping portion may include different cross-sectional shapes along the longitudinal axis of the handle. In some variations, one or more cross-sectional shapes may include a polygonal shape. For example, proximally, the gripping portion (506) may include a circular cross-sectional shape having a first diameter, while a central portion of the gripping portion (506) may include a polygonal shape having a faceted surface (e.g., two or more faces), and a distal end of the gripping portion (506) may include a circular cross-sectional shape. The polygonal shape may include a triangular prism, a quadrangular prism, a pentagonal prism, a hexagonal prism, an octagonal prism, and the like. In some variations, the faceted surfaces may collectively include a radius of curvature. In some variations, the cross-sectional shape of the shell of the handle at one or more flat regions may be different from the cross-sectional shape at any of the distal end, the neck, or the proximal portion of the distal portion.

[0134] 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 to functionally balance the deliberate movement required to rotate the distal end of the device with the precise control of the fine movements required during use.

[0135] In addition, the handles described herein can be configured to promote or otherwise facilitate forward gripping (i.e., more distal on the handle), which can provide the user with additional control over the cannula. For example, the gripping portion of the handle includes a taper (e.g., an elongated nose), such as Figure 5C As depicted. As shown, the grip portion (506) can include a taper from a maximum height (562A) to a minimum height (564A) of the grip portion (506). The taper in the distal portion can facilitate a user's forward grip of the handle (i.e., a grip of the distal portion on the handle). Advantageously, a user's grip further distally on the handle places the user's hand closer to the patient's eye, thereby allowing the user more control over the cannula. Additionally, the taper from each of the top and bottom surfaces (510A / 512A) to the distal end (542) provides a user with a position to place an index finger distal to the actuator (550A / 550B) (e.g., the grip portion (506)). The user can seamlessly move their index finger or thumb between the grip portion (506) and the actuator (550A / 550B) to access Schlemm's canal (e.g., advance the device into Schlemm's canal, pierce the trabecular meshwork, advance the distal tip of the cannula into Schlemm's canal), actuate the elongated member, and / or deliver a fluid composition. Additionally, the taper from the maximum height (562A) to the minimum height (564A) of the grip portion (506) provides multiple resting points for the user's fingers, which can additionally help reduce user fatigue.

[0136] Proximal end of the handle

[0137] Fig. 6A A perspective view of a delivery device (600) is depicted, the delivery device comprising 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 can include a circular cross-sectional shape having a diameter. In some variations, the proximal portion (603) of the handle (602) can have a constant diameter along the longitudinal axis, or the diameter can vary along the longitudinal axis (e.g., the diameter can taper to a smaller diameter at the proximal end (607)). In some variations, the proximal portion (603) can have a rectangular or elliptical cross-sectional shape with a major axis and a minor axis. The proximal end (607) can 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 transfer of the fluid composition from the exterior of 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. Fig. 6A As shown, the housing (604) of the handle (602) of the delivery device (600) may include an opening (612) at a proximal end that is configured to at least partially receive a connector (620) therein. Advantageously, having a connector (620) that is removably coupled to a fluid assembly (608) at the proximal opening (612) of the housing (604) allows a user to easily and quickly transfer a necessary volume of a fluid composition to a fluid reservoir of the delivery device. Additionally or alternatively, in some variations, the delivery device may be configured to automatically seal the fluid within 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 engagements to facilitate coupling the connector to the handle. For example, the fluid reservoir may include a threaded engagement to allow the connector to be coupled to the fluid reservoir. In some variations, the fluid reservoir may include other engagement features to allow the connector to be coupled 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.

[0138] The connector (620) can be configured to connect to the housing (602) via the proximal opening (612). The connector (620) can have a connector lumen (624) therethrough. The connector lumen (624) can be in fluid communication with the proximal lumen opening (622) and can terminate at one end in the proximal lumen opening and at another end in a distal lumen opening (626). When the connector (620) is coupled to the delivery device (600) at the opening (612), the connector lumen (624) can provide fluid communication between the proximal lumen opening (622) and the fluid reservoir (610). An external fluid device can be coupled to the connector (620), for example, a portion of the external fluid device (e.g., a distal end) can be placed into the proximal lumen opening (622) to deliver the fluid composition to the fluid reservoir (610). Once a 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 removed from the delivery device (600), thereby allowing the user to deliver the fluid composition to the eye, as will be described in more detail herein.

[0139] It should be understood that the connector (620) can be connected to the housing and not connected to the housing via a number of mechanisms. For example, the connector can be rotatably coupled to the housing or can be axially coupled to the housing (without rotation). For example, in variations where the connector is axially coupled to the housing, the connector can include a snap-fit ​​connector, a bayonet fit, and / or any other connector suitable for axial connection. Figure 6B A perspective view of a proximal opening (612) of a housing (604) is shown. As described above, the proximal opening (612) can be configured to releasably couple a connector to the housing (604) of a handle (602). The handle 602 can include a proximal cavity 634, which can be at least partially defined by the proximal opening 612. The proximal cavity (634) can receive the connector therein. In some variations, the housing (604) can include a coupling hub (614) having a plug (616) positioned therein. The coupling hub (614) can extend proximally into the proximal cavity (634). The plug (616) can have any suitable cross-sectional shape, and can be, for example, hexagonal, circular, square, oval, etc. The plug (616) can have a plug lumen (618), which can be in fluid communication with a fluid reservoir (610). Plug (616) and plug lumen (618) may be configured to direct a fluid composition transferred through the connector to a fluid reservoir. In some variations, plug (616) retains a valve by trapping sealing member (650) within a proximal aperture of fluid reservoir (610).

[0140] like Figure 6B As shown, the coupling hub (614) can be configured to threadably engage the connector (see Fig. 6A ). In some variations, the coupling hub (614) may include a coupling portion (630) configured to mate with a corresponding portion of the connector. The coupling portion (630) may include a mechanical coupling, such as, for example, threads. In other variations, the coupling portion (630) may include other mechanical coupling features (e.g., press fit, interference fit, snap fit, magnetic fit, etc.). In some variations, the mechanical coupling (e.g., threads) may extend radially outward from the coupling hub (614) into the proximal cavity (634), such as Figure 6B . In some variations, the housing (604) may include a threaded engagement portion (632) extending inwardly into the proximal cavity (634). In some variations, the threaded engagement portion (632) may be distally angled to allow the connector to be rotated in a distal direction into the proximal cavity (634). The threaded engagement portion (632) may be configured to facilitate rotational movement of the connector tab, as will be described herein.

[0141] Figure 6C A rear view of a handle (602) including a proximal opening (612) and a proximal cavity (634) is shown. The proximal cavity (634) may include additional components to allow the connector to transfer a fluid composition to a fluid reservoir (610). For example, a sealing member (650) may be positioned within the proximal cavity (634) and may be configured to seal against the fluid reservoir (610) distal to the coupling hub (614). The sealing member (650) may include an O-ring constructed of any elastomeric material. In some variations, the sealing member (650) may be configured to help direct the fluid composition into the fluid reservoir (610).

[0142] In some variations, the fluid reservoir (610) may include a valve distal to the sealing 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 to ensure 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 to Schlemm's canal through the elongated member), and 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 one-piece duckbill valve, or a similar simple valve, etc. In some variations, the valve may be composed of a single silicone component.

[0143] 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 threaded 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. In addition, when the connector (620) is disengaged from the coupling hub (614) in a second direction opposite to the first direction, the connector (620) may contact the one or more abutments (654A / 654B), thereby preventing further rotational movement in the second direction and indicating to the user that the connector (620) has been completely disengaged from the coupling hub (614) and can be removed from the proximal opening (612) in a proximal direction.

[0144] casing

[0145] Re-reference Figure 2 , the cannula (208) of the delivery system (200) can generally be coupled to and extend from the distal end of the housing (206) of the handle (202). The cannula (208) can be configured to provide easy and minimally invasive access to Schlemm's canal, such as during minimally invasive endo-approach surgery. In some variations, the cannula (208) can be fixedly attached to the distal end of the housing (206). In other variations, the cannula (208) can 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) can be removably attached to the distal end of the housing (206).

[0146] Some variations of the cannula (208) may include multiple portions having different geometric configurations. For example, in some variations, the cannula (208) may include a proximal end, a straight portion, and a curved portion distal to the straight portion, wherein the curved portion has a proximal end and a distal end and a radius of curvature. In other variations, typically, the cannula may include a curved portion, wherein the curved portion may include a first curved portion and a second curved portion. The second curved portion may include a larger radius of curvature than the first curved portion. However, it should be understood that in other variations, the cannula may be completely straight (e.g., may include only a straight portion and may not include a curved portion). The cannula may also include a distal tip and an inner cavity extending from the proximal end through the distal tip. The inner cavity of the cannula may be in fluid communication with a component of the fluid assembly as described above. In some variations, the distal tip may include one or more angled surfaces and may also include a sharp piercing tip, as described in more detail below.

[0147] The cannula can be made of any suitable material having sufficient hardness and biocompatibility to allow it to be advanced through the anterior chamber and into Schlemm's canal. For example, the cannula can be formed of a metal such as stainless steel, titanium, aluminum, or alloys thereof (e.g., Nitinol metal alloy), a polymer, a ceramic, or a composite material. Exemplary polymers include, without limitation, polycarbonate, polyetheretherketone (PEEK), PEKK, PEI, polyimide, polyamide, polysulfone, or a fluoropolymer. In some cases, it may be advantageous to coat the cannula with a lubricating polymer to reduce friction between the ocular tissue and the cannula during surgery. Lubricating polymers include, without limitation, hydrophilic coatings (such as polysaccharides), hydrophobic coatings, polyvinyl alcohol, polyethylene glycol, polyvinyl pyrrolidone, fluorinated polymers (including polytetrafluoroethylene (PTFE or Teflon ® )) and polyethylene oxide. In variations where the cannula is reusable, the cannula may be made of a sterilizable (eg, via autoclave) material, such as a heat-resistant metal (eg, stainless steel, aluminum, titanium).

[0148] Sleeve tube can have outer diameter usually, and the size of this outer diameter is set to be able to approach the lumen of Schlemm's canal, and simultaneously hinders the visual field of surgeon to the minimum.Therefore, outer diameter range can be about 50 microns to about 1000 microns.In some modifications, outer diameter range can be 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 500 microns.Sleeve tube also has scope can be about 50 microns to about 400 microns, about 100 microns to about 350 microns or about 150 microns to about 300 microns inner diameter.Sleeve tube can also be formed to have any suitable cross-sectional shape, for example, circular, oval, triangle, square, rectangle etc.In some modifications, sleeve tube can include the tapered profile along its length.

[0149] exist Figure 7 , a cannula of an exemplary delivery system is shown in more detail in . As shown, the cannula (700) may include 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 curvature radius (R) of the cannula may include two or more different radii of curvature, including a compound curve or an inverted curve. The compound curve may have a first curve portion having a first radius of curvature that curves in a first direction, and a second curve portion having a second radius of curvature that curves in the same direction as the first direction and having a second radius of curvature that is different from the first radius of curvature. The reversal curve may have a first curve portion having a first radius of curvature curved in a first direction, and a second curve portion having a second radius of curvature curved in a direction different from the first direction, as will be described in more detail herein.

[0150] The curved portion (704) may also have an inner radius (720) defined by the surface of the cannula (700) closest to the center of the radius of curvature (R), and an outer radius (722) defined by the surface of the cannula further from the center. The configuration of the curved portion (704) and the distal tip (706) may be beneficial or advantageous for allowing easy, atraumatic, and controlled access to 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), thereby allowing movement of the proximal end (702) to be easily translated into movement of the distal tip (706) to give 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.

[0151] Utilizing a cannula (700) having: a straight portion (714), a curved portion (704) having a proximal end (708) and a distal end (710) with a radius of curvature therebetween, and a distal tip (706) may be particularly useful for accessing the lumen of Schlemm's canal. The cannula (700) including the straight portion (714) and the curved portion (704) may 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) may have a length of about 18 mm. The cross-sectional shape of the curved portion of the cannula may be uniform, or the shape may vary. In some variations, the cross-sectional size of the cannula may vary along the curved portion (e.g., the cannula may taper), and in some cases, the cross-sectional size may be smaller closer to the distal end to facilitate entry into Schlemm's canal. The radius of curvature of the curved portion can be adapted to facilitate tangential entry and precise and minimally invasive entry into Schlemm's canal, and can 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 can be about 2.5. The cannula can also have a first angular span defined by an arc created by an inner radius (720) and a proximal edge (724). In some variations, the cannula can have a second angular span defined by an arc created by an outer radius (722) and a distal edge (726). The first angular span or the second angular span can be adapted to facilitate entry into Schlemm's canal, and can range from about 70 degrees to about 170 degrees or from about 100 degrees to about 150 degrees. In one embodiment, the first angular span or the second angular span can be about 100 degrees to about 120 degrees, including about 110 degrees.

[0152] The distal tip of the cannula can be sized, shaped, and have an appropriate geometry to allow easy and minimally invasive access to Schlemm's canal. For example, the distal tip (706) can include a compound curve between the proximal edge (724) and the distal edge (726) that can facilitate sliding of the trabecular meshwork over and up the distal edge (726) to provide an access point in the trabecular meshwork through which the elongated member can access Schlemm's canal, as will be described in greater detail herein. It will be appreciated that the access point can include an opening to or within Schlemm's canal, including an opening in the trabecular meshwork.

[0153] 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 may range 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, for example, it may be about 0.1 mm, about 0.2 mm, about 0.3 mm, or about 0.4 mm. In some variations, where the distal tip is positioned directly adjacent to (behind) 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).

[0154] As described above, the cannula can include a proximal end, a curved portion, a straight portion, and a distal tip. The cannula can 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 away from the radius of curvature. The curved portion can terminate at the distal tip at the outer radius or the inner radius. Different variations of the cannula can include different curved portion configurations. In some variations, the curved portion of the cannula can be configured to orient the trajectory of the elongated member when the elongated member extends from the cannula or advances away from the cannula. FIG. 8A to FIG. 8E Depicted are outlines of variations of cannulas with different proximal ends and bends. Advantageously, the different variations of cannulas can allow a user more control over the distal tip of the cannula, thereby making it easier to place the cannula within Schlemm's canal and seat the distal tip of the cannula within Schlemm's canal when delivering a fluid composition to the eye. For example, the different variations of cannulas described herein can allow a user to use the same access point location when treating both hemispheres of Schlemm's canal.

[0155] like Fig. 8AAs depicted, the cannula (800A) may 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) may be substantially straight or may include a curve. The curved portion (812A) may have a proximal segment (814A) and a distal segment (816A) having a compound curve therebetween. In some variations, the proximal segment (814A) and the distal segment (816A) may be included in a compound curve, or each of the proximal segment (814A) and the distal segment (816A) may be substantially straight with a compound curve therebetween. The compound curve may include two or more curves that curve in the same direction, wherein each of the two or more curves includes 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 section (814A) of the curved portion (812A) may have a flatter curve, and the distal section (816A) of the curved portion (812A) may have a steeper curve. In some variations, the distal section (816A) of the curved portion (812A) may orient the trajectory of the elongated member as it extends from the distal section (816A) of the curved portion (812A) of the cannula (800A).

[0156] like Figure 8B As shown, in some variations, the cannula (800B) may include a curved portion between the proximal end (810B) and the distal tip (822B), wherein the curved portion includes an inverted curve (e.g., a modified S-shaped curve). The inverted curve may include two or more curves, wherein at least one curve is curved in a first direction having a first radius of curvature, and at least one curve is curved in a second direction opposite to the first direction and includes a second radius of curvature different from the first radius of curvature.

[0157] As described above, the compound curve between the proximal segment (814) and the distal segment (816) may have two or more different radii of curvature. Figure 8C In the variation shown, the distal section (816C) of the curved portion (812C) may include a second radius of curvature that is greater than the first radius of curvature of the proximal section (812C), thereby allowing the curved portion (812C) to be more curved than the proximal section (812C). Fig. 8ACompared to the depicted embodiment, the proximal portion (814C) has a steeper curve and the distal segment (816C) has a flatter curve. In some variations, when the slender member extends from the distal segment (816C) of the curved portion (812C) of the cannula, the distal segment (816C) of the curved portion (812C) having a second radius of curvature greater than the first radius of curvature of the proximal segment (814C) can orient the trajectory of the slender member along the trajectory of the second radius of curvature of the distal segment (816C).

[0158] For example, in some variations, the compound curve may include a proximal segment having a greater radius of curvature than the distal segment, or the distal segment may have a greater radius of curvature than the proximal segment. In some variations, the ratio of the radius of curvature of the proximal segment of the compound curve to the radius of curvature of the distal segment 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 segment of the compound curve to the radius of curvature of the proximal segment 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 one variation, the distal segment may include a radius of curvature of about 0.10 inches, and the proximal segment may include a radius of curvature of about 1.00 inches. In some variations, the radius of curvature of the distal segment may be between about 0.05 inches and about 0.5 inches, and the radius of curvature of the proximal segment may be between about 0.5 inches and about 1.2 inches.

[0159] In each of these variations, the distal tip may be positioned on the outer radius or the inner radius. Fig.8D A variation of a cannula (800D) having a curved portion (812D) is depicted, wherein the proximal portion (814D) includes a flatter curve and the distal segment (816D) includes a steeper curve. In this variation, the distal tip (822D) may be located on the inner radius (818D). Having the distal tip (822D) located on the inner radius (818D) changes the orientation of the distal tip (822D) relative to the user and may provide the user with additional flexibility when placing the distal tip (822D) within Schlemm's canal.

[0160] like Fig. 8EAs shown, the cannula (800E) can be curved and can include a proximal section (814E), a distal section (816E), which can include a compound curve. The proximal section (814E) can be curved and can include a first radius of curvature, and the distal section (816E) can also be curved and can include a different second radius of curvature. In this variation, the second radius of curvature can be greater than the first radius of curvature, and the first radius of curvature can be in an opposite direction compared to the second radius of curvature. The combination of the first and second radii of curvature in opposite directions and having different values ​​can bias the distal tip (822E) of the cannula (800E) so that it is positioned along the central axis (830E) of the proximal section of the cannula (for example, in variations in which the proximal section or a portion thereof is straight), but a majority of the cannula (800E) can be offset from the central axis. In some variations, the central axis (830E) of the cannula can bisect the distal tip (822E) of the cannula. Advantageously, configuring the cannula (800) such that the distal tip (822E) of the cannula (800E) is 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) can improve the positioning of the distal tip (822E) relative to the handle, such that the user can more easily predict and understand the position of the distal tip (822E) relative to the anatomy of the eye during surgery, even when the distal tip may not be visually accessible. In other variations, including variations in which the proximal section of the cannula or a portion thereof is not straight, the distal tip (822E) of the cannula can be positioned along and / or bisect the central longitudinal axis of the handle. In some variations, the central longitudinal axis of the handle can be parallel to and / or substantially aligned with the central axis (830E) of the proximal section of the cannula. In some variations, a distal section (816E) comprising a second radius of curvature greater than the first radius of curvature may orient the trajectory of the elongate member as it extends from the cannula.

[0161] Distal tip of cannula

[0162] The distal tip of the cannula can be placed in Schlemm's canal and can be used to help form an access point in the trabecular meshwork for the elongated member to enter Schlemm's canal. When deployed to Schlemm's canal, the distal tip can help form an access point in the trabecular meshwork. When the fluid composition is delivered to the two hemispheres of Schlemm's canal, the configuration of the distal tip can allow the user to form and use the same access point (e.g., incision). The distal tip can be shaped into various variations described herein, and the configuration of the distal tip can facilitate entry and placement in Schlemm's canal. The configuration of the distal tip disclosed herein can be configured to easily bias or support the distal tip against the scleral wall without piercing or piercing the scleral wall. The shaping of 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 in the distal end of the cannula. Each of the embodiments described below may include beneficial features that provide advantages for easy and minimally invasive access to Schlemm's canal for disrupting the trabecular meshwork and / or positioning the distal tip within Schlemm's canal. Fig.9A A perspective view of a distal tip (922) of a cannula (906) is depicted. 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 elongated member may exit the cannula through the lumen opening (930). The lumen opening (930) may include any suitable shape, including, but not limited to, a teardrop shape, an oval shape, a circle, a pentagon, a hexagon, an irregular shape, and the like.

[0163] The proximal edge (940) may be straight or rounded. In some variations, the proximal edge (940) may include a medial proximal edge (942) and an lateral proximal edge (944). The medial proximal edge (942) and the lateral proximal edge (944) may define a base (982). The distal edge (950) may include a medial distal edge (952) and an lateral distal edge (954). The medial distal edge (952) and the lateral distal edge (950) may define a tongue (980). The tongue (980) may be used to disrupt the trabecular meshwork and may be positioned within Schlemm's canal during delivery of the fluid composition to the eye. Typically, the distal tip may have a length. For example, the distal tip (922) may have a length (972) from the proximal edge (940) to the distal edge (950). Typically, the tongue can have a length, wherein typically, the length of the tongue can include a distance from the inner distal edge to the outer distal edge along the longitudinal axis. The length of the tongue can include a percentage of the length of the distal tip. For example, the length of the tongue 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.

[0164] In some variations, the distal edge (950) may be rounded or straight. The distal edge (950) may be sharp and 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), the straight portion (960), the proximal edge (940), the curved portion (962), the base (982), and the tongue (980) may be substantially smooth (e.g., electropolished) to prevent damage to the elongated member. Typically, a cannula having a lumen therein may have a cannula wall having a wall thickness. For example, as Fig.9AAs shown, 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), wherein the wall thickness (998) at the proximal edge (940) may be substantially greater (e.g., 2 times, 3 times, 4 times, etc.) than the wall thickness (998) at the distal edge (950). In some variations, the taper of the wall thickness along the distal tip may allow the distal tip to more easily penetrate the trabecular meshwork, thereby forming an access point therethrough through which the elongated member is deployed. In some variations, the distal tip may include a side cutout configured to narrow the diameter of the tongue, thereby allowing the tongue to be placed into Schlemm's canal.

[0165] Fig. 9B Depicted Fig.9A A side perspective view of one embodiment of a distal tip (922) of the cannula. As described above, the cannula (906) may include an inner radius (918) defined by a surface of the cannula (906) that is closest to the radius of curvature and an outer radius (920) defined by a surface of the cannula (906) that is further away from the radius of curvature. In addition, the distal tip (922) includes a distal edge (950) that includes a straight portion (960) of the distal tip, followed by a proximal edge (940) that includes 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 may 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), such as Fig. 9B . Angle (970) may be generally acute, and in some variations may be in the range of about 14 degrees to about 40 degrees (including all values ​​and subranges therein). For example, in some variations, 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 distal tip (922) to be placed tangentially to Schlemm's canal when inserted into Schlemm's canal, thereby allowing the elongated member to easily follow the trajectory of the cannula when extending from the cannula in order to properly place the elongated member in Schlemm's canal.

[0166] In some variations, the straight portion (960) of the distal tip may have one or more straight segments (e.g., two, three, four, or more). 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 include a compound curve. 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 it should be understood that any combination of the straight portion (960) of the distal tip and the 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 used with a curved portion of the distal tip that includes multiple curves having different radii of curvature, while in other variations, a straight portion of the distal tip having multiple straight segments having different slopes may be used with a curved portion of the distal tip having 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 having different slopes may be used with a curved portion of the distal tip having multiple curved segments.

[0167] Fig. 9C Describes something like FIG. 9A to FIG. 9B A variation of the distal tip (922C) of the depicted cannula (906C). In this variation, the distal tip (922C) includes a straight portion (960C) of the distal tip and a curved portion (962C) of the distal tip. The straight portion (960C) of the distal tip and the outer radius (920C) can form an angle (970C) in the range of about 18 degrees to about 26 degrees. Where the angle (970C) is in the range of about 18 degrees to about 26 degrees, the distal tip (922C) can be curved to the distal tip (962C). Fig. 9B The curved portion (962C) of the distal tip may have a shallower curve than the curved portion (962) of the distal tip in the embodiment of the present invention. In addition, this variation allows the trabecular meshwork to slide up along the straight portion (960C) of the distal tip and at least partially up along the curved portion (962C) of the distal tip, thereby forming an access point for the slender member to exit the lumen opening (930C) of the sleeve (906) and enter Schlemm's canal.

[0168] In some variations, the distal tip may comprise a longitudinal midpoint configured to divide cannula (1000) into two sections. Fig.10Another variation of the distal tip (1022) is shown. In this variation, the distal tip (1022) may include a longitudinal midpoint (1070) and a straight portion (1060) of the distal tip that may form a first angle (1084). The distal tip (1022) may also include a second angle (1086) formed between the longitudinal midpoint (1070) and the proximal edge (1040). The first angle (1084) may generally be in the range of about 14 degrees to about 35 degrees, including all values ​​and subranges therein. For example, the first angle (1084) may be in the range of about 27 degrees to about 35 degrees or about 14 degrees to about 22 degrees. The second angle (1086) may generally be an obtuse angle and 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.

[0169] The distal tip described herein may generally have a length measured between a distal edge and a proximal edge along the longitudinal axis of the device. For example, Fig.10 A variation of a distal tip (1022) is depicted that includes a length (1072) measured along a longitudinal axis (1070) from a proximal edge (1040) to a distal edge (1050). In some variations, the length of the distal tip described herein may be about 0.013 mm to about 0.035 mm (including all values ​​and subranges therein). For example, the length may be about 0.0145 mm to about 0.0185 mm, or about 0.015 mm to about 0.019 mm, or 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 that include both a straight portion and a curved portion, the length may include a corresponding length of the straight portion and / or the curved portion, each length being similarly measured along the longitudinal axis. This may be in Fig.10, where length (1072) is the length of the distal tip, length (1061) is the length of the straight portion (1060), and length (1063) is the length of the curved portion (1062). In some variations, the straight portion and the curved portion may comprise an equal percentage 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 where the length of the straight portion comprises 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 where the length of the curved portion may comprise 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 can be about 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 that include both straight and curved portions, the straight portion can have a length in the range of about 0.066 mm to about 0.032 mm, and the curved portion can have a length in the range of about 0.003 mm to about 0.063 mm. In other variations that include both straight and curved portions, the curved portion can have a length in the range of about 0.066 mm to about 0.032 mm, and the straight portion can have a length in the range of about 0.003 mm to about 0.063 mm. As described above, generally, the length of the straight portion can include the length of the tongue. In other words, the length of the tongue is a subset of the length of the straight portion. In some variations, length (1072) may include a length (1061) of straight portion (1060) and a length (1063) of curved portion (1062), the length of the straight portion including the length of tongue (1080). In some variations, the length of the tongue may range from about 0.001 mm to about 0.02 mm. In some variations, straight portion (1060) may include a side cutout (1061) configured to allow insertion of straight portion (1060) into Schlemm's canal.

[0170] FIG. 11A to FIG. 11L 1 and 12. Views showing different variations of distal tip (1122) are shown. Each of the variations of distal tip (1122A-1122L) may be used with any disclosed embodiment of the cannula (described above and FIG. 8A to FIG. 8E ) to form a cannula that can be used in a delivery system. Fig.11A, showing a distal tip (1122A) having a length (1172A) including a straight portion (1160A) of the distal tip and a curved portion (1162A). With a defined length (1172A), a longer straight portion (1160A) ensures that the curved portion (1162A) includes a steeper curve, while a shorter straight portion (1160A) ensures that the curved portion (1162A) can include a flatter curve. In some variations, when the straight portion (1160A) includes a greater percentage of the length (1172A) than the curved portion (1162A), the distal tip (1122A) can be inserted deeper into Schlemm's canal. FIG. 11A to FIG. 11L Each of the different variations of the distal tip (1122A-1122L) shown in the figures can be configured to allow the trabecular meshwork to slide upward along a straight portion of the distal tip and a portion of the curved portion of the distal tip to provide an access point through the trabecular meshwork through which the elongated member can access Schlemm's canal.

[0171] like Fig.11A As shown, the curved portion (1162A) can include a compound curve having two curves that bend in the same direction, each having a different radius of curvature. Angle (1170A) is the angle between the straight portion (1160) and the outer radius (1120A), and in some variations, can be in the range of about 14 degrees to about 20 degrees. In some variations, the distal tip (1122A) can taper from the proximal edge (1140A) to the distal edge (1150A). The distal edge (1150A) can be rounded or curved to allow the distal tip (1122A) to be placed against the scleral wall or anterior chamber without damaging or puncturing the scleral wall or anterior chamber during deployment.

[0172] 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 rather than rounded, such as Fig. 11B As shown. The straight distal edge (1150B) can easily pierce the trabecular meshwork. In some variations, the tongue (1180B) can also include a tongue channel (1190B) extending from the lumen opening (1130B) to the distal edge (1150B). The tongue channel (1190B) can facilitate the trabecular meshwork to pass through the tongue (1180B) and slide upward along the curved portion (1162B). The tongue channel (1190B) can facilitate the trabecular meshwork to slide inwardly toward the lumen opening (1130B). The tongue channel (1190B) can also be configured to constrain and guide the elongated member to leave the lumen opening (1130B).

[0173] In some variations, the straight portion may have an elongated taper along its length, which may allow the tongue and straight portion to be positioned deeper within Schlemm's canal during deployment of the distal tip. Fig. 11C As shown, the straight portion (1160C) includes an elongated taper along the length (1172C), thereby allowing the tongue (1180C) and the straight portion (1160C) to be positioned deeper within Schlemm's canal during deployment of the distal tip (1122C). The elongated taper of the straight portion (1160C) can provide a gradual lift of the trabecular meshwork during deployment of the distal tip (1122C). In some variations, the straight portion (1160C) can have chamfered edges, beveled edges, or rounded edges.

[0174] like Fig.11D Depicted, with Fig. 11C In comparison to the depicted variation of the distal tip (1122C), the straight portion (1160D) may have a sharper taper along the length (1172D). The sharper taper of the straight portion (1160D) may provide an overall shorter length (1172D) of the distal tip (1122D), thereby allowing a user to perform delicate movements of the distal tip (1122D). Generally speaking, in some variations, the distal tip length may include equal portions of the length of the straight portion and the length of the curved portion. However, as described above, in some variations, one of the length of the straight portion (1160D) and the length of the curved portion (1162D) may include a greater percentage (e.g., >50%) of the distal tip length (1172D). For example, in Fig. 11C In the embodiment, the length of the straight portion (1160C) comprises a greater percentage of the distal tip length (1172C), while in Fig.11D In the embodiment of the present invention, the length of the curved portion (1162D) comprises a greater percentage of the distal tip length (1172D). In addition, in Fig.11A , the length of the straight portion (1160A) and the length of the curved portion (1162A) comprise an equal percentage of the distal tip length (1172A).

[0175] 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.11EVariations of a distal tip (1122E) having an elliptical lumen opening (1130E) are depicted. In some variations, the distal tip (1122E) may include a first straight portion (1160E1), a second straight portion (1160E2), a first curved portion (1162E1), and a second curved portion (1162E2). When the distal tip (1122E) is formed, each of the first straight portion (1160E1) and the first curved portion (1162E1) and the second straight portion (1160E2) and the second curved portion (1162E2) include a shallow angle that intersects along a midline of the distal tip (1122E). The first straight portion (1160E1) and the second straight portion (1160E2) may meet at a distal edge (1150E), wherein the distal edge (1150E) may be a point or may be rounded. The first curved portion (1162E1) and the second curved portion (1162E2) may meet at a proximal edge (1140E), wherein the proximal edge (1140E) may be a point or may be rounded. The distal tip (1122F) may be configured to easily penetrate the trabecular meshwork and lift the trabecular meshwork onto the distal tip of the cannula.

[0176] As described above, the straight portion of the distal tip may include a first straight portion and a second straight portion, wherein the first straight portion is distal to the second straight portion. Fig.11F and Fig.11G , showing a distal tip (1122F) comprising a first straight portion (1160F1) and a second straight portion (1160F2). Fig.11G In this variation as seen in FIG. 1 , the distal tip length ( 1172F) includes only the length of the first straight portion ( 1161F) and the length of the second straight portion ( 1163F). In other words, there is no curved portion in this variation. Fig.11F In the embodiment shown in FIG. 1 , the distal tip ( 1122F) may include a channel ( 1190F). In some variations, such as Fig.11FAs can be seen in FIG. 1 , the channel (1190F) can taper distally, while in other variations, the channel (1190F) can taper proximally or can have a constant width so as not to taper. The channel (1190F) can be configured to constrain and guide the elongated member along the direction of the channel (1190F) when the elongated member is actuated to leave the lumen opening (1130F). The first straight portion (1160F1) and the second straight portion (1160F2) can form a first angle (1198F). In some variations, the first angle (1198F) can be about 90 degrees to about 150 degrees (including any values ​​and sub-ranges therein). The first straight portion (1160F1) can be configured to lift the trabecular meshwork when the trabecular meshwork slides upward along the first straight portion (1160F1), thereby allowing the elongated member to easily enter Schlemm's canal. The first straight portion (1160F1) can also be inserted into Schlemm's canal. The second straight portion (1160F2) can be configured to constrain the elongated member as it exits the cannula at the cannula lumen opening. The first straight portion (1160F1) can have a smaller (i.e., flatter) slope than the second straight portion (1160F2). The configuration of the first and second straight portions (1160F1, 1160F2) can help to form a sufficiently large access point within the trabecular meshwork while constraining the elongated member as it moves through the access point into Schlemm's canal. In some variations, constraining the elongated member includes maintaining an appropriate trajectory for the elongated member as it exits the cannula.

[0177] Fig.11H Another variation of the distal tip (1122G) is shown. In this variation, the distal tip (1122G) includes a straight portion (1160G) having a chamfered edge and a curved portion (1162G), wherein the length (1162G) of the straight portion (1160G) may include a greater percentage of the distal tip length (1172G) than the length (1163G) of the curved portion (1162G), thereby allowing a user to place the distal tip (1122G) further into Schlemm's canal. In addition, the cannula may include a cannula wall thickness defined by an outer wall of the cannula and an inner wall of the cannula. For example, as Fig.11IAs shown, the sleeve (1106G) may include a wall thickness (1192G) defined by an outer wall (1194G) and an inner wall (1196G). The wall thickness may vary along the distal tip length, including tapering distally toward the distal edge. For example, the wall thickness may 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 thick. The wall thickness may be about 0.01 mm to about 0.04 mm, about 0.01 mm to about 0.03 mm, or about 0.01 mm to about 0.02 mm. The wall thickness may 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 may 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 may 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 may be uniform along the distal length, may taper uniformly along the distal length, or may taper rapidly toward the distal edge. In some variations, the wall thickness (1192G) may remain constant along the distal tip length (1172G), such as Fig.11H The uniform wall thickness (1192G) along the distal tip length (1172G) can be configured so that the cross-sectional area of ​​the tongue (1180G) fits within Schlemm's canal.

[0178] As described above, the distal edge may be straight or rounded. Fig.11I As shown, the distal edge (1150G) can have a rounded edge that is configured to be placed against the scleral wall. The constant wall thickness (1192G) and the rounded configuration of the distal edge (1150G) can allow the user to confidently place the distal edge (1150G) against the scleral wall without piercing the scleral wall and minimizing the risk of damaging the scleral wall tissue, which would require significant perceptible force.

[0179] In some variations, the base of the distal tip may extend distally to a sharp 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 apex may be rounded, while in other variations, one or more of each apex may not be rounded (e.g., it may be angular). Referring now to Figures 11J to 11LThe distal tip (1122H) may include a base (1182H) extending to a base apex (1183H) and a tongue (1180H) extending to a tongue apex (1181H). The base apex (1183H) may be proximally offset from the tongue apex (1181H), such as Figures 11J to 11L as shown. In other words, in some variations, the tongue may 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 the tongue apex may be axially aligned such that the base apex and the tongue apex are parallel to each other. In some variations, the base apex may have a larger radius of curvature than the tongue apex, thereby producing a more rounded shape at the base apex, while in other variations, the tongue apex may have a larger radius of curvature than the base apex, thereby producing a more rounded shape at the tongue apex. In other variations, the tongue apex and the base apex may have the same radius of curvature, wherein the tongue apex and the base apex have the same shape (see Fig.11L ).

[0180] Advantageously, in this variation, each of the tongue apex (1181H) and the base apex (1183H) can simultaneously encounter the trabecular meshwork during deployment into the eye, thereby creating 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), wherein the first curved portion (1162H1) is positioned proximal to the first straight portion (1160H1) and includes 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) can include a second straight portion (1160H2) and a second curved portion (1162H2), wherein 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) together with the first curved portion (1162H1) may form a continuous curve between the first straight portion (1160H1) and the second straight portion (1160H2) and connect the first straight portion and the second straight portion. The distal tip length (1172H) may be measured from the proximal end (1195H) of the base (1182H) to the tongue apex (1181H). In this variation, the straight portion (1160H1 / 1160H2) includes a greater percentage of the distal tip length (1172H) than the curved portion (1162H1 / 1162H2).

[0181] In some variations, such as Figure 11K As shown, each of the first and second straight portions and the first and second curved portions may include chamfered or beveled edges. During deployment, the user can easily place any surface or edge against the scleral wall, including the base apex (1183H), the tongue apex (1181H), the distal edge (1150H), or the proximal edge (1140H) without damaging the tissue. In addition, the user can Fig.11J The distal tip (1122H) is shown oriented with the tongue apex (1182H) upward or with the base apex (1182H) oriented upward, thereby providing enhanced versatility of the distal tip (1122H) during deployment.

[0182] How to use

[0183] In some variations, methods for treating eye conditions may include using a single delivery system to expand Schlemm's canal and / or tear the trabecular meshwork. In some cases, treating eye conditions may cause increased aqueous humor drainage, reduced aqueous humor outflow resistance, and / or reduced intraocular pressure. Some methods described herein may expand Schlemm's canal, expand collecting channels, and / or destroy any diaphragm that may block the circumferential flow through Schlemm's canal. Expansion of Schlemm's canal may destroy the obstructing inner wall of the canal, stretch the trabecular meshwork, and / or increase the porosity of the trabecular meshwork. This may improve the natural water outflow path. Expansion may be performed by delivering a fluid composition (e.g., a viscoelastic fluid as described herein). Some methods described herein may include performing a trabeculotomy to cut the trabecular meshwork. Some methods described herein may include implanting an ocular device into Schlemm's canal. In some cases, the systems described herein can be used to perform an internal trabeculotomy, an internal transluminal trabeculotomy, a clear corneal trabeculotomy, a clear transluminal corneal trabeculotomy, an internal viscocanaloplasty, and / or a clear viscocanaloplasty.

[0184] Loading the fluid composition into the delivery device

[0185] Before fluid composition is delivered to eyes, fluid composition can be loaded into delivery device from external fluid device.It is important to keep the sterility of fluid composition, while fluid composition is quickly transferred to the fluid reservoir in the housing of delivery device from external fluid device, without any additional air being introduced into fluid assembly, and any existing air in fluid assembly is removed simultaneously.In some modifications, delivery system can include external fluid device configured to be connected to connector, and this connector is removably connected to delivery device.External fluid device can deliver fluid to the fluid reservoir in delivery device by connector.Connector with removably connected to delivery device allows fluid to be seamlessly and aseptically transferred to fluid reservoir from external fluid device.When fluid flows through fluid assembly and arrives at the distal tip of the elongated member being communicated with fluid reservoir fluid, fluid composition can quickly remove any existing air in fluid assembly.Once fluid composition has been transferred, the connector with external fluid device connected thereto can be easily and quickly removed from delivery device, thereby allowing delivery device to be deployed to eyes. FIG. 12A to FIG. 12C An exemplary method of delivering a fluid from an external fluid device (1240) to a fluid reservoir (1210) of a delivery device (1200) is depicted, the method comprising coupling the external fluid device to a handle of the delivery device using a connector of a fluid component of the delivery device, transferring a fluid composition into the fluid reservoir of the delivery device, and separating both the connector and the external fluid device from the handle of the delivery device.

[0186] like Fig. 12A As shown, the delivery device (1200) includes a handle (1202) having a housing (1204), wherein a cannula (1206) is coupled to a distal end of the housing (1204). The delivery device (1200) may also 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 a fluid composition. The contents of the fluid composition may be as described above. The external fluid device (1240) may include a syringe, a vial, or another container for storing a fluid.

[0187] 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 the 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 the volume of fluid to the fluid reservoir (1210) via the connector (1220). The 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 the fluid composition that is greater than the defined volume of the fluid reservoir (1210) may be transferred to the delivery device (1200), wherein the additional volume of the fluid composition is used to prime the delivery device (1200) by removing any air within the fluid assembly and / or the elongated member. Excess fluid may flow out of the distal tip of the cannula (1206) or the elongated member, thereby indicating to the user that the delivery device (1200) has been primed with fluid and is ready to deliver the fluid to the eye.

[0188] The method of delivering fluid from an external fluidic device to a fluid reservoir may also include removing the external fluidic device (1240) and the connector (1220) from the handle (1202), such as Fig. 12C As shown. Removing the external fluid device (1240) and the connector (1220) may include removing the connector (1220) while the connector remains coupled to the external fluid device (1240). In other words, 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 the 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 (122) axially away from the handle housing. Removing external fluid device (1240) and connector (1220) from handle (1202) may include retracting or otherwise pulling external fluid device (1240) and connector (1220) proximally from handle (1202). In some variations, removing the external fluid device and connector from the handle may include pressing a release button on the handle and removing the connector from the handle.

[0189] The coupled connector (1220) and external fluidic device (1240) may be as follows Fig. 12C As shown, the connector (1220) and the external fluid device (1240) are removed from the delivery device (1200). Removing the connector (1220) and the external fluid device (1240) together in a single step can advantageously simplify the surgical setup. The user can, for example, engage the connector (1220) using the tab (1222), and can axially move the connector (1220) to further separate the connector (1220) (and the external fluid device (1240) coupled thereto) from the delivery device (1200). In some variations, the connector (1220) and the external fluid device (1240) can be processed, and the delivery device (1200) can be used to deliver the fluid composition to the eye, as will be described in more detail below. It should be understood that although described above as a single removal step (e.g., removing the connector and the external fluid device together), the two components can be released separately from the handle of the delivery device (e.g., the external fluid device can be detached from the connector, and the connector can then be detached from the housing of the handle).

[0190] Perform eye surgery

[0191] Fig.13 A flow chart of an exemplary method (1300) for treating a condition of an eye is shown, the method comprising delivering a fluid to an eye. In some variations, a delivery device of a fluid delivery system may be included within a package, such as a single-use package. In these variations, the method may include removing the delivery device from the package (1302). As described above, the delivery device may or may not be packaged with a connector that is coupled to a housing of a handle. In the following variations, in which the delivery device is packaged with the connector detached or the connector is otherwise detached when preparing the delivery device for use, the method may include coupling the connector to the handle at a proximal opening. In some variations, coupling the connector to the housing of the handle includes releasably coupling the connector to a coupling hub within a proximal cavity of the handle. In some variations, coupling the connector to the housing of the handle 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.

[0192] The method (1300) may also include delivering a fluid from an external fluid device to a fluid reservoir through a connector (1304). Delivering a fluid from an external fluid device through a connector to a fluid reservoir may include delivering a fluid composition from the external fluid device through a connector, the connector being releasably coupled to a fluid reservoir included in a housing of a handle of a delivery device, the fluid reservoir being in fluid communication with an elongated member slidably positioned within a sleeve coupled to the handle. Delivering a fluid from an external fluid device to a fluid reservoir through a connector 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 in a threaded engagement. In some variations, delivering fluid from the external fluid device to the fluid reservoir may include delivering the fluid composition to the fluid reservoir through the connector until the fluid composition is received at the distal end of the cannula or the fluid reservoir is filled and any remaining air has been purged from the cannula and the slender member.

[0193] In some variations, the method (1300) may further include removing the connector and the external fluid device from the delivery device (1306). In some variations, removing the connector and the external fluid device from the delivery device may include removing the connector and the external fluid device while the external fluid device is coupled to the connector. In some variations, removing the connector and the external fluid device from the delivery device may include rotating the connector in a second direction opposite to the first direction and / or axially retracting the connector, and removing the connector from the proximal cavity of the handle. Removing the connector and the external fluid device from the delivery device may include rotating the connector in a second direction opposite to the first direction (e.g., using one or more tabs of the connector). In some variations, removing the connector and the external fluid device from the delivery device may include rotating the connector to release the connector and the external fluid device from the handle.

[0194] In some variations, the method may generally include the following steps: creating an incision in an ocular wall (e.g., sclera or cornea) that provides access to the anterior chamber of the eye; advancing a cannula of a delivery system through the incision and at least partially across the anterior chamber to the trabecular meshwork; approaching Schlemm's canal with the cannula. The method as described above may also include the steps of irrigating or flushing the system with a fluid composition (e.g., to remove air from the system) and / or flushing the surgical field to clear blood or otherwise improve visualization of the field of view. The surgeon may first use a surgical microscope and a gonioscope or gonioprism to observe the anterior chamber and the trabecular meshwork (with Schlemm's canal below). Then, using a corneal, limbal, or scleral incision of 0.5 mm or greater, the surgeon may then approach the anterior chamber. A saline solution or viscoelastic composition may then be introduced into the anterior chamber to prevent it from collapsing. Here, the saline solution or viscoelastic composition may be delivered through the cannula of the delivery system, or delivered by another mode, such as by infusion via a flushing sleeve on the cannula. The surgeon then advances the cannula of the delivery system through the incision toward the anterior chamber angle under direct microscopic visualization. When approaching the angle (and thereby approaching the trabecular meshwork), the surgeon may apply a gonioscopic lens or a gonioprism to the cornea to visualize the angle. Application of a viscous fluid (e.g., a viscoelastic composition as previously described) to the cornea and / or a gonioscopic lens or a gonioprism may help achieve good optical contact and eliminate total internal reflection, thereby allowing visualization of the anterior chamber angle. When the surgeon observes the trabecular meshwork, the cannula may then be advanced so that the distal tip of the cannula pierces the mesh and communicates with the lumen of Schlemm's canal.

[0195] The method (1300) may also include advancing the cannula into the anterior chamber of the eye (1308) and piercing the trabecular meshwork with the distal tip of the cannula to enter Schlemm's canal (1310). In some variations, piercing the trabecular meshwork with the cannula tip may ... FIG. 11A to FIG. 11LIn some variations, piercing the trabecular meshwork with the distal tip may include lifting the trabecular meshwork with the distal edge to slide the trabecular meshwork upward along a portion of the distal tip. Sliding the trabecular meshwork upward along a portion of the distal tip may create an access point in the trabecular meshwork through which the elongated member may be advanced. Piercing the trabecular meshwork with the distal tip may include piercing the trabecular meshwork with a distal tip having a distal edge and a proximal edge, the distal edge comprising a straight portion, a curved portion having a compound curve, the compound curve having two or more curves curved in the same direction. In some variations, piercing the trabecular meshwork with the distal tip may include piercing the trabecular meshwork with a distal tip, wherein the distal tip comprises a straight portion, a curved portion comprising a reverse curve, the reverse curve having two or more curves, wherein at least one curve is curved in a first direction and at least one curve is curved in a second direction different from the first direction. In some variations, the distal tip may include a straight portion, the straight portion comprising a first straight portion distal to a second straight portion. In some variations, piercing the trabecular meshwork with the distal tip may include sliding the trabecular meshwork upward along a straight portion and a portion of the curved portion of the distal tip to provide an access point in the trabecular meshwork through which the elongated member may be advanced.

[0196] In some variations, the method may generally include advancing a slidable elongated member coaxially disposed within the lumen of the cannula into the tube under gonioscopic visualization. The method (1300) may also include advancing the elongated member around Schlemm's canal (1312). The elongated member may be advanced around the tube by any suitable amount and direction. For example, the elongated member may be advanced between about 1 degree and about 360 degrees around the tube, between about 10 degrees and about 360 degrees around the tube, between about 150 degrees and about 210 degrees around the tube, or any suitable distance, about 360 degrees around the tube, about 270 degrees around the tube, about 180 degrees around the tube, about 120 degrees around the tube, about 90 degrees around the tube, about 60 degrees around the tube, about 30 degrees around the tube, or about 5 degrees around the tube. In some variations, the elongated member may be advanced in two steps, e.g., 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 tube (e.g., thereby achieving a 360 degree or 180 degree internal viscoelastic canalillotomy or viscocanaloplasty). In some variations, the elongated member may be advanced in one step around the tube (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 a corresponding degree of internal viscoelastic canalillotomy or viscocanaloplasty. Advancing the elongated member about Schlemm's canal comprises advancing the elongated member about Schlemm's canal using a drive assembly. In some variations, advancing the elongated member about Schlemm's canal using a drive assembly comprises advancing or retracting the elongated member about Schlemm's canal using one or more actuators including one or more wheels, sliders, or buttons as described herein.

[0197] The method (1300) also includes delivering a fluid (e.g., a fluid composition) to Schlemm's canal (1314). The fluid composition can be injected while the elongated member is advancing or retracting. Once the slidable elongated member has been positioned within the tube, the fluid composition (e.g., a viscoelastic solution) can be delivered continuously or intermittently through the lumen of the elongated member. The fluid composition can leave the lumen of the elongated member through the distal end of the elongated member (e.g., through the distal tip), or through an opening or fenestration set along the axis of the elongated member, or a combination of both. The openings or fenestrations can be spaced apart in any suitable manner along the axial length of the elongated member, such as symmetrically or asymmetrically along its length. If desired, other substances, such as drugs, air, or gases, can be delivered in the same manner. In some variations, retracting the elongated member can include using a first actuator to retract the elongated member and simultaneously delivering the fluid to Schlemm's canal, while in other variations, the retraction of the elongated member and the delivery of the fluid can be completely separated. Thus, in some variations, the method may include delivering a fluid to Schlemm's canal and then retracting the elongated member, or vice versa. This combination of delivering a fluid and retracting the elongated member (and / or advancing the elongated member) may be performed any suitable number of times during surgery. It should be understood that the elongated member may be advanced and / or retracted around Schlemm's canal by any desired amount 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 the fluid, including using a single actuator for all operations, using separate actuators for all operations, 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 the fluid to Schlemm's canal.

[0198] In some methods, the elongated member including the inner cavity can be advanced into Schlemm's canal, and the fluid composition can be delivered via the elongated member. The elongated member and / or the fluid delivery can expand Schlemm's canal, and the fluid delivery can additionally expand the collecting channel. The entire length of Schlemm's canal or a part thereof can be expanded by the fluid. For example, at least 75%, at least 50%, at least 25%, at least 10% of the tube or at least 1% of the tube can be expanded. The fluid composition can also be delivered to treat various medical conditions of the eyes, including but not limited to glaucoma, early glaucoma, anterior or posterior segment neovascular disease, anterior or posterior segment inflammatory disease, high intraocular pressure, uveitis, age-related macular degeneration, diabetic retinopathy, hereditary eye disease, cataract surgery complications, vascular occlusion, vascular disease or inflammatory disease.

[0199] In some variations, the slidable elongated member can be repositioned by retracting or repeatedly advancing and retracting. In some variations of the method, the same or different incisions can be used, but the delivery system cannula is used to approach and expand Schlemm's canal from different directions (e.g., counterclockwise instead of clockwise). Once a sufficient amount of fluid has been delivered, the surgeon can retract the slidable elongated member into the cannula and remove the delivery system from the eye. It should be understood that the cannula described here can be specifically manufactured to include a double-surface configuration (i.e., sharp and smooth surfaces) at the distal tip, which can allow the elongated member to be advanced, repositioned and / or retracted without cutting off the elongated member on the distal tip of the cannula. It should also be understood that these steps can be used alone or in combination with cataract surgery (disposable).

[0200] More generally, in the methods described herein, an exemplary volume of a deliverable viscoelastic fluid may be between about 1µl and about 200µl in some cases, or between about 1µl and about 100µl in some cases. In some cases, a sufficient volume range to provide a destructive force may be from about 1µl to about 50µl, from about 1µl to about 30µl, from about 2µl to about 16µl, from about 5µl to about 25µl, or from about 8µl to about 21µl. In one variation, a volume of about 4µl is sufficient to damage Schlemm's canal and / or surrounding tissue. In other variations, the amount of viscoelastic fluid sufficient to disrupt the trabecular meshwork canalicular tissue may be about 2µl, about 3µl, about 4µl, about 5µl, about 6µl, about 7µl, about 8µl, about 9µl, about 10µl, about 11µl, about 12µl, about 13µl, about 14µl, about 15µl, about 16µl, about 17µl, about 18µl, about 19µl, about 20µl, about 21µl, about 22µl, about 23µl, about 24µl, about 25µl, about 26µl, about 27µl, about 28µl, about 29µl, about 30µl, about 35µl, about 40µl, about 45µl, or about 50µl. In other variations, the amount of viscoelastic fluid sufficient to disrupt the trabecular meshwork tubular tissue may be between about 50µl and about 100µl, including, for example, about 55µl, about 60µl, about 65µl, about 70µl, about 75µl, about 80µl, about 85µl, about 90µl, about 95µl, or about 100µl.

[0201] The method (1300) may include removing the distal tip of the cannula from Schlemm's canal (1316). 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, where fluid has not been delivered throughout Schlemm's canal, the method (1300) may include the optional steps of rotating the cannula 180 degrees (1318) and reinserting the distal tip into Schlemm's canal (1320). 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 rotating the handle (e.g., without rotating the handle).

[0202] The method (1300) may also include advancing the elongated member around Schlemm's canal (1322) and delivering the fluid to Schlemm's canal (1324). Advancing the elongated member around Schlemm's canal may include advancing the elongated member a remaining path around Schlemm's canal, including, for example, between about 0 degrees and about 360 degrees around Schlemm's canal. Advancing the elongated member around Schlemm's canal includes advancing the elongated member around Schlemm's canal using a drive assembly. As described above, advancing Schlemm's canal around the elongated member using the drive assembly includes advancing Schlemm's canal around the elongated member using one or more mechanical actuators, including one or more wheels, sliders, or buttons. Retracting the elongated member as described above, delivering the fluid to Schlemm's canal may include delivering the 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 the fluid to Schlemm's canal.

[0203] Some of the delivery systems described herein can be configured to limit the cumulative amount of advancement and / or retraction of the slidable elongated member. For example, as described above, after the elongated member can be advanced and retracted for a specific cumulative distance (e.g., the advancement and retraction are each about 39 mm to about 40 mm, corresponding to the approximate circumference of Schlemm's canal; or the advancement and retraction are each about 78 mm to about 80 mm, corresponding to about twice the circumference of Schlemm's canal; or any other suitable distance), the elongated member may no longer be able to advance. The advancement and retraction can occur in multiple advancement-retraction cycles. For example, the elongated member can advance about 20 mm, then retract about 20 mm, then advance about 20 mm, then retract about 20 mm. When the cumulative distance is limited to about 40 mm, after these two advancement and retraction cycles, the elongated member may no longer be able to advance. In other variations, the delivery system may not limit the cumulative amount of advancement and / or retraction of the elongated member.

[0204] In some variations of the endo-method, the fluid composition can be delivered simultaneously with the retraction of the elongated member (i.e., the fluid composition can be delivered in a manner where the retraction of the system components allows the fluid to leave the system cannula and advance). It should be understood that the delivery system can be configured so that the fluid composition is delivered continuously, passively, automatically or actively by the surgeon. The fluid composition can also be delivered to the tube with a pump or auxiliary plunger independently of the movement of the gear shaft. In some variations, the retraction of the elongated member can correspond to a fixed volume of the fluid composition delivered via the lumen of the elongated member. The fluid composition can be delivered via the distal opening of the lumen of the elongated member when the elongated member is retracted, and thus, the fluid can be uniformly delivered throughout the portion of the tube through which the elongated member advances.

[0205] Fluid compositions that can be delivered by the system described herein include, but are not limited to, saline and viscoelastic fluids. The viscoelastic fluid may include hyaluronic acid, chondroitin sulfate, cellulose, their derivatives or mixtures, or their solutions. In one variation, the viscoelastic fluid includes sodium hyaluronate. In another variation, the viscoelastic composition may also include a drug. For example, the viscoelastic composition may include a drug that is suitable for treating glaucoma, reducing or lowering intraocular pressure, alleviating inflammation, fibrosis, new blood vessel formation or scarring, and / or preventing infection. For example, in some variations, the viscoelastic composition may include a therapeutic agent described herein, such as, but not limited to, a Rho kinase (ROCK) inhibitor and an agent for gene therapy, DNA, RNA, or a stem cell-based method.

[0206] The viscoelastic fluid can also include reagents that contribute to the visualization of the viscoelastic fluid. For example, dyes can be included, such as but not limited to fluorescent yellow, trypan blue or indocyanine green. In some variations, fluorescent compounds or bioluminescent compounds are included in the viscoelastic composition to help its visualization. In other variations, the system can deliver the drug alone without delivering the viscoelastic composition. In this case, the drug can be loaded onto or wherein the biodegradable polymer of sustained release, and the biodegradable polymer can elute the drug within a few weeks, months or years. As described herein, it is also contemplated that air or gas can be delivered with the system.

[0207] When the elongated member of the device controlled by one hand, a single operator is advanced from Schlemm's canal in clockwise direction, counterclockwise direction or both, or during the elongated member is withdrawn from Schlemm's canal, a viscoelastic fluid can be delivered. As previously described, viscoelastic fluid can be delivered to destroy Schlemm's canal and surrounding trabecular meshwork tubule tissue. For example, the viscoelastic fluid delivered can cause destruction by expanding Schlemm's canal, increasing the porosity of trabecular meshwork, stretching trabecular meshwork, forming microtears or perforations in near tubule tissue, removing diaphragm from Schlemm's canal, expanding collecting channel or their combination. The elongated member can be loaded with viscoelastic fluid at the beginning of ocular surgery so that fluid can be delivered by a single device. This is contrasted with other systems and / or devices including viscoelastic fluids that use clamps or other advancement tools to advance fluid delivery catheters into Schlemm's canal, and the device is separated or independent from delivery catheter or catheter advancement tool, and during surgery when delivery catheter or catheter advancement tool is held by a surgeon, it is necessary to be connected to delivery catheter or catheter advancement tool by an assistant.

[0208] Some of the methods described in more detail herein may include dilating Schlemm's canal and / or the aqueous humor collecting channel (e.g., with a viscoelastic fluid) using a delivery system described herein. The method may also include tearing or cutting the trabecular meshwork of Schlemm's canal. These methods may be performed separately, or they may be combined into a single operation. For example, in some cases, a portion (e.g., half) of Schlemm's canal may be dilated (e.g., using a fluid composition), and the trabecular meshwork of the same or different portions of Schlemm's canal may be torn or cut in 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 subsequently torn or cut. For example, this may be desirable in order to both dilate the collecting channel and tear or cut the trabecular meshwork.

[0209] In some of these variations, expansion and tearing or cutting can be performed using a single delivery system (such as a delivery system configured to deliver a fluid composition as described herein). For example, the elongated member of the delivery system configured to deliver a fluid composition can first be used to deliver the fluid composition to a portion of Schlemm's canal as described herein (e.g., an arc of about 180 degrees of the canal, an arc of about 90 degrees of the canal, etc.), and then tear or cut the trabecular meshwork in the same portion of the canal as described herein. As another example, a catheter configured to deliver a delivery system of a fluid composition can first be used to deliver the fluid composition to a portion of Schlemm's canal (e.g., an arc of about 180 degrees of the canal, an arc of about 90 degrees of the canal, etc.), and then tear or cut the trabecular meshwork in another portion of the canal (e.g., another arc of about -180 degrees, another arc of 90 degrees, etc.). As yet another example, an elongated member of a delivery system configured to deliver a fluid composition can first be used to 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, and then delivering about 180 degrees of the fluid composition in a second direction), and then subsequently tear or cut all 360 degrees of the trabecular meshwork (e.g., by tearing or cutting about 180 degrees of the trabecular meshwork in a first direction, and then tearing or cutting about 180 degrees of the trabecular meshwork in a second direction). In another example, an elongated member of a delivery system configured to deliver a fluid composition can first be used to 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 subsequently tear or cut all 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).

[0210] In other variations, different delivery systems may be used for dilation and tearing or cutting (e.g., dilation may be performed using a delivery system configured to deliver a fluid composition, and tearing or cutting may be performed using a delivery system not configured to deliver a fluid). In another example, in some cases, dilation may be performed in one eye of a patient, while tearing or cutting the trabecular meshwork may be performed in the other eye of the patient.

[0211] Surgery involving dilating Schlemm's canal and / or tearing or cutting the trabecular meshwork can also be combined with surgery to deliver an ocular device in the same eye or in a different eye of the same patient. For example, all or a portion of Schlemm's canal can be dilated and the ocular device subsequently inserted. As another example, a portion of the trabecular meshwork can be torn or cut, and an ocular implant can be delivered to another portion of Schlemm's canal. In another example, a portion of Schlemm's canal can be dilated, and an ocular implant can be delivered to another portion of Schlemm's canal. In another example, an ocular implant can be delivered to a portion of Schlemm's canal, and then Schlemm's canal can be subsequently dilated to improve the function of the ocular implant.

[0212] Any suitable ocular device that keeps Schlemm's canal unobstructed or improves aqueous humor outflow can be implanted. For example, an ocular device that keeps Schlemm's canal unobstructed and does not substantially interfere with the fluid flow across, along or out of the canal can be implanted. Such devices can include a support member with at least one fenestration, as disclosed in U.S. Patent No. 7,909,789 and U.S. Patent No. 8,529,622, which are previously incorporated by reference in their entirety. An ocular device that destroys the adjacent inner wall of the proximal tubule trabecular meshwork or Schlemm's canal can also be implanted. In addition to the ocular device made of metal or metal alloy, the use of sutures, modified sutures, modified polymers, polymer filaments or solid viscoelastic structures can also be delivered.

[0213] Other variations of the endoscopic approach include the use of an endoscope. Similar to the method directly described above, the anterior chamber is first approached by cutting the cornea, limbus or sclera. Similarly, this can be performed in combination with cataract surgery once or after cataract surgery, or independently. The anterior chamber can be injected with saline solution or a viscoelastic composition can be placed in the anterior chamber to prevent it from collapsing. Saline or viscoelastic can be delivered as a separate step, or can be infused with the elongated member of the delivery system, the flushing sleeve on the elongated member or cannula, or with a separate infusion cannula. Then, the surgeon advances the endoscope through the incision and toward the angle and trabecular meshwork under direct microscopic visualization. When the surgeon visualizes the trabecular meshwork via an endoscope or any related display, the bevel of the cannula advances to pierce the mesh. Then the elongated member is advanced under endoscopic visualization. The elongated member can advance any suitable amount and direction around the tube. For example, slender member can advance about 10 degrees to about 360 degrees around the pipe, or it can advance in two steps, for example, advance 180 degrees clockwise around the pipe and advance 180 degrees counterclockwise (thereby realizing all 360 degrees of inner road viscoelastic canalectomy). Once slender member has been positioned in the pipe, fluid composition (for example, viscoelastic fluid) can be continuously or intermittently delivered by the lumen of slender member. Fluid composition can leave the lumen of slender member by the distal end of slender member (for example, by distal tip) or by the opening or fenestration provided along the shaft of slender member, or a combination of the two. Opening or fenestration can be spaced apart in any suitable manner along the axial length of slender member, for example symmetrically or asymmetrically along its length. If desired, other materials, such as medicine, air or gas, can be delivered in the same manner. Slender member can be repositioned by retracting or repeatedly advancing and retracting. In some variations of the method, the same or different incisions may be used, but the delivery system cannula may be used to approach 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 elongated member into the cannula. In some variations, the surgeon may then remove the delivery system from the eye; in other variations, the surgeon may retain the delivery system in the eye and perform a trabeculotomy, as described in more detail herein.

[0214] Tissue disruption can be achieved by using at least about 1µl, at least about 2µl, at least about 3µl, at least about 4µl, at least about 5µl, at least about 6µl, at least about 7µl, at least about 8µl, at least about 9µl, at least about 10µl, at least about 11µl, at least about 12µl, at least about 13µl, at least about 14µl, at least about 15µl, at least about 16µl, at least about 17µl, at least about 18µl per 360 degree arc. In some embodiments, at least about 20µl, at least about 25µl, at least about 30µl, at least about 35µl, at least about 40µl, at least about 45µl, or at least about 50µl of viscoelastic fluid may be delivered. In other variations, at least about 55µl, about 60µl, about 65µl, about 70µl, about 75µl, about 80µl, about 85µl, about 90µl, or about 100µl of viscoelastic fluid may be delivered.

[0215] Depending on factors such as the type or severity of the condition being treated, the disruptive force generated may partially or completely disrupt and / or remove the trabecular meshwork, and may be adjusted by varying the volume of viscoelastic fluid delivered.

[0216] In addition, fluid composition can be delivered to restore the tubular anatomical structure of Schlemm's canal, remove the obstruction in the canal, destroy the inner wall or dilatation tube of the near tubule trabecular meshwork in the canal or Schlemm's canal.Here, delivery system can include silk, tube, balloon, the apparatus of energy delivery to tissue and / or other features that contribute to these methods.It is expected that such system with additional features can be used to treat glaucoma.The surface of these systems can also be rough or have projection, to further destroy the inner wall and the near tubule trabecular meshwork of Schlemm's canal, thereby strengthen aqueous humor outflow or permeability.In addition, it should be understood that delivery system as described herein can be used for fluid composition to be delivered to the anterior chamber or anterior segment.

[0217] Trabeculotomy

[0218] The methods described herein may include performing a trabeculotomy. The methods described herein (as well as systems and devices), including methods for providing destructive forces to trabecular meshwork canalicular tissue, may be well suited for use in internal trabeculotomy and goniotomy because they avoid the use of electrocautery and enable the elongated member to be advanced over a greater arc of Schlemm's canal. In some cases, the destructive tool may include a destructive component on its distal portion. Exemplary destructive components include, without limitation, notches, hooks, barbs, balloons, or combinations thereof. In other cases, the destructive tool may not include a destructive component on its distal portion and may actually have a non-traumatic blunt distal portion. Exemplary non-traumatic distal portions include, without limitation, parasol or dome-shaped distal portions.

[0219] The outer diameter of the elongated member or tool can have different sizes for the destruction of tissue, similar to how the fluid volume can be changed to change the level of destruction. For example, an elongated member or tool with an outer diameter ranging from about 50 microns to about 100 microns can be advanced through the tube to slightly expand the tube and destroy or remove the septum that blocks the flow of the circumferential tubules. An elongated member or tool with an outer diameter ranging from about 100 microns to 200 microns can be used to perform the aforementioned operations, and can also begin to stretch the trabecular meshwork and near tubular tissue. An elongated member or tool with an outer diameter ranging from about 200 microns to about 300 microns can be able to perform the aforementioned operations, but can also form microtears in the trabecular meshwork and near tubular tissue, and can maximally expand the collection channel. An elongated member or tool with an outer diameter ranging from about 300 microns to about 500 microns can maximally destroy tissue and can form tears or perforations all along the trabecular meshwork and near tubular tissue. The elongated member or tool can be advanced out of the tip of the cannula and into the tube for about a 30 degree arc of the tube (e.g., advanced about 3 mm to 4 mm out of the cannula), about a 60 degree arc of the cannula (e.g., advanced about 6 mm to 8 mm out of the cannula), about a 90 degree arc of the cannula (e.g., advanced about 10 mm out of the cannula), about a 120 degree arc of the cannula (e.g., advanced about 15 mm out of the cannula), about a 180 degree arc of the cannula (e.g., advanced about 20 mm out of the cannula), or a full 360 degrees of the cannula (e.g., advanced about 36 mm to 40 mm out of the cannula) to achieve maximum intraocular pressure reduction. In some variations, the elongated member can have a non-uniform outer diameter. For example, the elongated member can have a tapered outer diameter such that the outer diameter increases from the distal end to the proximal end.

[0220] In some variations, the methods disclosed herein may include advancing the elongated member between an arc of about 5 degrees and an arc of about 360 degrees of Schlemm's canal. In some variations, the method may include advancing the elongated member (or tool) through an arc of about 360 degrees of Schlemm's canal, an arc of about 270 degrees of Schlemm's canal, an arc of about 120 degrees of Schlemm's canal, an arc of about 180 degrees of Schlemm's canal, or an arc of about 90 degrees of Schlemm's canal. In yet further variations, the advancement of the elongated member (or tool) may be an arc of about 0 degrees to 5 degrees of Schlemm's canal, an arc of about 30 degrees of Schlemm's canal, or an arc of about 60 degrees of Schlemm's canal. The advancement may be performed from a single approach point in Schlemm's canal or from multiple approach points in the canal. It may be beneficial to advance the elongated member from a single approach point in Schlemm's canal through an arc of about 180 degrees of Schlemm's canal in both clockwise and counterclockwise directions. In other variations, the elongate member may be advanced from a single access point in Schlemm's canal in a single (clockwise or counterclockwise) direction through approximately 360 degrees of Schlemm's canal.

[0221] The trabecular meshwork can be destroyed during the advancement of the slidable elongated member. It is also possible to use the body segment of the elongated member near the tip to be customized to have one or more notches, barbs or balloons, when the distal tip is guided and advances along Schlemm's canal, these notches, barbs or balloons hook the mesh, thereby destroying, partially tearing, tearing and / or removing the trabecular meshwork when advancing. In addition, an implant with a specially designed edge for cutting the mesh can be used.

[0222] In other methods, the trabecular meshwork can be destroyed during the retraction of the slidable elongated member. The method for destroying tissue can involve customizing the system (e.g., elongated member, any catheter or wire, probe tip, etc.) to hook or grab the mesh when retracting after advancing through the tube. This can be done using a wire with a curved tip, hook, notch or barb on its end, which advances through the lumen of the catheter and then buckles the mesh when retracting, tears the mesh along its length or removes the mesh completely, or simply uses a metal or polymer wire or suture (no catheter) to complete, the tip (and / or body) of the metal or polymer wire or suture being hooked, strangled or barbed in such a way that it can advance into Schlemm's canal without tearing the mesh, but buckles the mesh when retracting, thereby tearing the mesh and / or removing the mesh completely. The elongated member can be provided with a destructive tool, for example, a sharp edge element, which can cut or tear the trabecular meshwork when retracted into a sleeve that remains stationary. Exemplary sharp edge elements may be hooks, wires, or any other suitable shape memory component that may extend from the cannula to tear, cut, or remove the trabecular meshwork.

[0223] Another method for disrupting tissue can include using an oversized elongated member (e.g., having an outer diameter of 300 to 500 microns) to tear the mesh upon delivery, or expanding or inflating the elongated member to stretch, disrupt, rupture, or completely tear the mesh once the elongated member has been fully advanced into Schlemm's canal. For example, a catheter / elongated member, stylet, or wire (with or without a lumen) can be used with a tip outer diameter of 200 to 250 microns, but with a shaft that begins to flare outward to about 300 microns, to about 400 microns, or to about 500 microns after 3 o'clock in Schlemm's canal (i.e., at about the 5 mm or 10 mm mark on the catheter / elongated member) so that as the tip is comfortably advanced within Schlemm's canal, the enlarged shaft trails behind and ruptures the trabecular meshwork as it is advanced.

[0224] In another method, cutting, disrupting, removing, etc. of the trabecular meshwork can be achieved by removing the cannula from the eye while leaving the elongated member in the cannula to tear the meshwork. For example, the cannula can be inserted into the anterior chamber and Schlemm's canal, and a tool (e.g., a slidable elongated member) can be advanced within the cannula. The cannula can be removed from the anterior chamber without retracting the elongated member. This action itself can tear the trabecular meshwork. When the cannula is removed from the anterior chamber, the elongated member can tear the trabecular meshwork starting from the point where the cannula is inserted into Schlemm's canal, and can continue tearing around the trabecular meshwork toward the distal end of the elongated member.

[0225] The method described herein can be used to approach the trabecular outflow system using a single clear corneal incision, and can allow up to 360 degrees of transluminal trabeculotomy. The method can use a flexible, elongated member, which can be advanced and retracted using a single-handed disposable manual instrument. In a variation of the method, when the flexible, elongated member advances into Schlemm's canal, the cannula can be firmly held against the angle. The exposed portion of one or more wheels can be rotated proximally so that the flexible, elongated member advances up to about 180 degrees (about 20mm of circumferential tube travel) around Schlemm's canal. For example, the elongated member can advance about 90 degrees, 135 degrees, or 180 degrees. At this point, the flexible, elongated member can be fully extended in some cases, and the wheel may no longer be able to rotate. During the operation, direct microscopic or gonioscopic visualization of the cannula tip can be maintained, and the anterior chamber can be maintained with viscoelastic or continuous balanced salt solution infusion. Once the flexible, elongated member advances, the cannula can be removed from the eye through the incision without retracting the flexible, elongated member. This can cause the body of the flexible elongated member to tear or cut through the trabecular meshwork. In some cases, it may be desirable to bias the distal tip of the cannula toward the trabecular meshwork being cut; this helps prevent the flexible elongated member from slipping out of the tube during cannula removal in some cases.

[0226] These methods are generally minimally invasive, one-handed, single operator controlled methods, for example, they are tailored for use in an endo-approach procedure, which, as previously mentioned, can be advantageous over a more invasive exo-approach. However, the use of these systems in an exo-approach may be contemplated in certain circumstances and is thus not excluded herein. 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 (before or after) during the same course of treatment or at another time using the same incision.

[0227] Throughout this application, the term "about" is used to indicate that a value includes the inherent error variation of the device or method used to determine the value, or the variation present in the sample being measured. Unless otherwise specified or otherwise apparent from the context, the term "about" means within 10% above or below the reported value (unless the value would exceed 100% or be below 0% of the possible value). When used in conjunction with a range or series of values, the term "about" applies to the endpoints of the range or each value listed in the series, unless otherwise specified. As used in this application, the terms "about" and "approximately" are used as equivalents.

[0228] Although variations of the present invention have been shown and described herein, it will be appreciated by those skilled in the art that such variations are provided by way of example only. Without departing from the present invention, those skilled in the art will now appreciate that many variations, changes and substitutions are contemplated. It should be appreciated that various alternatives to the variations of the present invention described herein may be employed in the implementation of the present invention. The following claims are intended to define the scope of the present invention, and methods and structures within the scope of these claims and their equivalents are thus covered.

Claims

1. A device for delivering a fluid to an eye, the device comprising: a handle comprising a housing containing a fluid reservoir therein; a sleeve coupled to a distal end of the handle; an elongated member slidably positioned within the sleeve; as well as A connector is releasably coupled to the fluid reservoir in the handle, wherein the connector is configured to receive an external fluid device to transfer fluid into the fluid reservoir and to be released from the handle when the external fluid device is coupled to the connector.

2. The device of claim 1, wherein the handle comprises a proximal portion comprising a proximal cavity having a proximal opening, the proximal cavity having a coupling hub therein, the coupling hub comprising a coupling portion.

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

4. The device of claim 3, wherein the coupling portion comprises threads configured to engage a distal cavity wall of the connector.

5. The device of claim 2, wherein the handle comprises a sealing member distal to the coupling hub, the sealing member being configured to seal the fluid reservoir.

6. A device according to claim 2, wherein the connector includes a connector body, the connector body including one or more extensions, and the one or more extensions are configured to engage one or more abutments within the proximal cavity of the handle when the connector is connected to the connecting hub.

7. The device of claim 2, wherein the coupling hub comprises a plug having a plug lumen in fluid communication with the fluid reservoir.

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

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

10. The device of claim 9, wherein the textured surface comprises raised elements or recessed elements having the same shape.

11. The device of claim 9, wherein the textured surface comprises raised elements or recessed elements having different shapes.

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

13. The device of claim 10 or claim 11, wherein the textured surface comprises raised or recessed elements, wherein the raised or recessed elements have different cross-sectional areas or different diameters.

14. The device of claim 8, wherein the gripping portion comprises a top surface and a bottom surface, wherein the top surface or the bottom surface comprises one or more actuators.

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

16. The device of claim 8, wherein the gripping portion is symmetric across an XZ plane.

17. The device of claim 8, wherein the gripping portion is symmetrical across each of a YZ plane and an XZ plane.

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

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

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

21. The device of 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, wherein the first diameter is greater than the second diameter.

22. A method of delivering a fluid to treat a condition of the eye, the method comprising: a connector for coupling an external fluid device to a handle of a delivery device, wherein the delivery device comprises: the handle comprising a housing; a cannula coupled to the handle; a fluid reservoir; and an elongated member in fluid communication with the fluid reservoir and slidably positionable within the cannula; delivering fluid from an external fluid device via a connector that is releasably coupled to the fluid reservoir included within the housing of the delivery device; removing the connector from the delivery device with the external fluid device coupled to the connector; advancing the cannula of the delivery device into the eye; advancing the elongated member around Schlemm's canal; and Fluid is delivered to the eye via the elongated member.

23. The method of claim 22, wherein removing the connector and the external fluid device coupled to the connector from the delivery device comprises rotating the connector to remove the connector and the external fluid device from the delivery device.

24. The method of claim 23, wherein removing the connector and the external fluid device coupled to the connector from the delivery device comprises removing the connector from a proximal cavity within the handle.

25. The method of claim 24, wherein removing the connector and the external fluid device coupled to the connector from the delivery device comprises rotating the connector to disengage the connector from a coupling hub within the proximal cavity of the handle.

26. The method of claim 23, wherein removing the connector and the external fluid device coupled to the connector from the delivery device comprises rotating the connector in a second direction opposite the first direction using one or more tabs extending from a connector body.

27. A device for delivering a fluid to an eye, the device comprising: a handle including a fluid reservoir therein; a cannula coupled to the distal end of the handle, the cannula having a curved proximal portion, a curved distal portion, and a distal tip, wherein the curved proximal portion has a first radius of curvature and the curved distal portion has a second radius of curvature, wherein the first radius of curvature is greater than the second radius of curvature, and wherein the first radius of curvature and the second radius of curvature are in opposite directions; as well as An elongated member is slidably positioned within the cannula and is configured to deliver fluid to Schlemm's canal.

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

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

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

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

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

33. The device of claim 30, wherein the distal tip comprises a distal edge comprising an outer distal edge and an inner distal edge defining a tongue.

34. The device of claim 30, wherein the proximal edge further comprises an inner proximal edge and an outer proximal edge defining a base.

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

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

37. The device of claim 30, wherein the distal tip comprises a straight portion further comprising one or more straight segments.

38. The device of claim 37, wherein the straight portion comprises a plurality of straight segments, wherein each segment has a different slope.

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

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

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

42. The device of claim 41, wherein the length of the straight portion comprises a greater percentage of the length of the distal tip than the length of the curved portion.

43. The device of claim 41, wherein the length of the curved portion comprises a greater percentage of the length of the distal tip than the length of the straight portion.

44. The device of claim 41, wherein the sleeve further comprises an outer wall and an inner wall defining a wall thickness.

45. The device of claim 44, wherein the wall thickness tapers along the length of the distal tip.

46. ​​The device of claim 45, wherein the wall thickness tapers along the length of the straight portion.

47. The device of claim 45, wherein the wall thickness tapers along the length of the tongue of the straight portion.

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

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

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

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

52. The device of claim 51 wherein the distal tip of the cannula is bisected by the central longitudinal axis of the handle.

53. The device of 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 a fluid to an eye, the device comprising: a handle including a fluid reservoir at least partially therein, the handle including a housing having a proximal portion and a distal portion including a gripping portion, the gripping portion including a first curved side, a second curved side opposite the first curved side, and a tapered region distal to the first curved side and the second curved side, wherein the tapered region is configured to receive a finger of a user, a sleeve coupled to a distal end of the handle; as well as An elongated member is slidably positioned within the cannula and is configured to deliver fluid to Schlemm's canal.

55. The device of claim 54, wherein the first curved side and the second curved side are convex.

56. The device of claim 55, wherein the first curved side and the second curved side are symmetrical across an XZ plane parallel to a longitudinal midpoint.

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

58. The device of claim 57, wherein the gripping portion further comprises an actuator boundary surrounding the actuator.

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

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

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

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

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

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

65. The device of claim 54, wherein the gripping portion comprises a non-slip material on the tapered area.

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

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

68. The device of claim 54, wherein the first curved side has a first arc with a first center, the second curved side has a second arc with a second center, and the first center and the second center are on opposite sides of a central longitudinal axis of the cannula.

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