Ophthalmic device

Abstract

An ophthalmic device (4000) includes a housing (4100) and a cannula (4120) extending from the housing, the cannula having a lumen for fluid flow, a reservoir for holding fluid, and an activation assembly (4200). The activation assembly includes a rotatable wheel (4210) and a movable housing ring (4220) coupled to the wheel, the coupled rotatable wheel and movable housing ring configured to move together inwardly toward the interior of the housing when an inward force is applied to the wheel, and together move outwardly away from the interior of the housing when an outward force is applied to the coupled wheel and the movable housing ring. A method of operating an ophthalmic device is also provided.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims the benefit of priority to U.S. Provisional Patent Application Serial No. 63 / 412,072, filed on September 30, 2022, and entitled “OPHTHALMIC DEVICE,” and Serial No. 63 / 322,904, filed on March 23, 2022, and entitled “OPHTHALMIC DEVICE,” the entire contents of each application are incorporated herein by reference. Technical Field

[0003] The present disclosure relates generally to an ophthalmic device and, more particularly, to an ophthalmic device for delivering a viscous fluid to an eye. Background Art

[0004] In ophthalmic surgery, the high viscosity material commonly referred to as surgical viscoelastic material is injected into the eye as a surgical aid. The viscoelastic material used in ophthalmic surgery includes a composition containing hyaluronic acid, chondroitin sulfate or chemically modified cellulose. Due to the unusual shear thinning or thixotropic properties of such materials, the viscoelastic material can be injected through a small-bore needle or cannula, and then rebounds (recoil) a material providing a hard gel-like property after injection. During cataract surgery, viscoelastic material is usually injected into the anterior chamber of the eye to maintain the intraocular space and protect the corneal endothelium from mechanical damage. During glaucoma surgery, injection of viscoelastic material is used to expand tissue space, such as Schlemm's canal. Injection of viscoelastic material is also used for dissecting tissues, such as lens capsule or retina. Therefore, it is desirable to provide an ophthalmic device to penetrate the eye and inject viscous fluid into the eye. BRIEF DESCRIPTION OF THE DRAWINGS

[0005] The accompanying drawings, which are included to provide a further understanding of the disclosure and are incorporated in and constitute a part of this specification, illustrate embodiments of the disclosure and together with the description serve to explain the principles of the disclosure.

[0006] Figure 1 A cross-sectional elevational view of an ophthalmic device is depicted.

[0007] Figure 2 A cross-sectional elevational view of an ophthalmic device is depicted.

[0008] Figure 3 A cross-sectional elevational view of an ophthalmic device is depicted.

[0009] Figure 4 Depicted is a cross-sectional elevation view of an ophthalmic device having a pressure gauge.

[0010] Figure 5 Depicted is a graph of flow rate versus pressure for delivery of a viscoelastic material from an ophthalmic device.

[0011] Figure 6 Depicted is a cross-sectional elevational view of a composite microcannula having a tapered reinforcement element.

[0012] Figure 7 Depicted is a cross-sectional elevational view of a composite microcannula having two reinforcement elements, one full length and one partial length.

[0013] Figure 8 Depicted is a partial cross-sectional elevational view of a composite microcannula having a helically wound reinforcement element in the form of a circular wire.

[0014] Fig. 9 Depicted is a partial cross-sectional elevational view of a composite microcannula having a helically wound reinforcement element in the form of a flat ribbon.

[0015] Fig.10 Depicted are perspective and close-up views of a curved composite microcannula having a signal beacon tip extending beyond the distal tip of an outer sheath.

[0016] Fig.11 Depicted is a cross-sectional front view of a composite microcannula having a tapered reinforcement element and a rounded distal tip.

[0017] Fig.12 Depicted is a cross-sectional elevational view of a composite microcannula having a ball-ended distal tip formed separately from a communicating element and an optical fiber to provide a beacon for light dispersion at the tip.

[0018] Fig.13 Depicts a stylized cross-sectional view of the eye and some of the structures involved in the outflow of aqueous humor from the eye.

[0019] Fig.14 A perspective view of an exemplary delivery system for implanting an ocular device is depicted.

[0020] Fig.15 A side view of an exemplary cannula of a delivery system is depicted.

[0021] Fig.16A Depicted is a perspective view of an exemplary drive assembly in a handle of the system in a first orientation for use with one hand.

[0022] Fig. 16B Depicted Fig.16A , wherein the handle is in a second, flipped orientation where the handle can be used with the other hand.

[0023] Figure 17A-17BA perspective view of an exemplary engagement mechanism is depicted.

[0024] Fig.18 A perspective view of an engagement mechanism according to one variation is depicted.

[0025] Figure 19A-19B Depicted are perspective views of engagement mechanisms according to other variations.

[0026] Figure 20A-20B A perspective view of an engagement mechanism according to yet another variation is depicted.

[0027] Fig.21 A perspective view of another exemplary engagement mechanism is depicted.

[0028] Fig.22A Depicted is a perspective view of an exemplary delivery system for delivering a fluid composition into Schlemm's canal.

[0029] Fig. 22B Depicted Fig.22A A partial cross-sectional perspective view of a conveying system.

[0030] Figure 23A-23C Depicted are exemplary methods of delivering a fluid composition out of a delivery system.

[0031] Fig.24 An exemplary slidable conduit for conveying a fluid composition is depicted.

[0032] Figure 25A-Figure 25C Depicted are side or perspective views of slidable conduits according to other variations.

[0033] Fig.26 Depicted is a stylized depiction of an ab-interno approach into Schlemm's canal using a cannula of an exemplary delivery system.

[0034] Fig. 27 An exemplary cannula according to another variation is depicted.

[0035] Fig.28 Depicted is a stylized description of an endo-circuit approach to entering Schlemm's canal from a single point and delivering a viscoelastic fluid while advancing the fluid delivery conduit along a 360 degree arc of the canal.

[0036] Fig.29 Depicted is a stylized description of an in-line approach to entering Schlemm's canal from a single point and delivering a viscoelastic fluid while advancing the fluid delivery conduit in clockwise and counterclockwise directions along a 180 degree arc of the canal.

[0037] Figure 30A-Figure 30C An exemplary endoscopic approach to cutting or tearing the trabecular meshwork is depicted.

[0038] Figure 31A-Figure 31B Top views of embodiments of a cannula adapter are depicted in an undeployed configuration and a fully deployed configuration, respectively.

[0039] Figure 31C-Figure 31D Depicted Fig.31A Example of how the cannula adapter can be attached to a standard ophthalmic viscosurgical device (such as an ophthalmic viscoelastic syringe).

[0040] Figure 31E-Figure 31F Depicted Fig.31A An example of a surgical implementation of a cannula adapter access and insertion.

[0041] Figure 31G-Figure 31H Depicted Fig.31A Another example of a surgical implementation of cannula adapter access and insertion.

[0042] Fig.31I Depicted include Fig.31A A top view of a cannula adapter system, the cannula adapter being coupled to Fig.31C An additional adapter assembly is provided to the proximal end of a standard ophthalmic visco-surgical device to facilitate controlled fluid delivery.

[0043] Figure 32A-32B Depicted is a side view of another embodiment of a cannula adapter with a sliding trigger in an undeployed configuration and a fully deployed configuration.

[0044] Fig.32C Depicted Fig.32A A side view of a modification of an embodiment including a coupler to facilitate pneumatic fluid delivery.

[0045] Figure 32D-Figure 32E Describes the Fig.32C An example embodiment of a pneumatic system for use with a cannula adapter.

[0046] Fig.33A Another embodiment of a cannula adapter utilizing a compression spring to maintain force on an ophthalmic visco-surgical device is depicted.

[0047] Figure 33B-Figure 33D Depicted Fig.33A Example operation scheme of the cannula adapter.

[0048] Figure 34A-Figure 34C A three-layer assembly is depicted that may be incorporated into any embodiment of a cannula adapter.

[0049] Fig.34D Depicted Fig.34C Close-up side view of the distal tip of the three-layer assembly.

[0050] Figure 34E-Figure 34G Depicted Figure 34A-Figure 34C Example operation scheme of the three-tier components.

[0051] Figure 35A-Figure 38B Various embodiments of an internal support mechanism are depicted that may be incorporated into any embodiment of a cannula adapter.

[0052] Figure 39A-Figure 39B Depicted is an external top view of an embodiment of a cannula adapter having a dial-feed system illustrating an example scheme of operation of the cannula adapter.

[0053] Figure 39C-Figure 39D Depicted showing Fig.39A An internal top view of an example operating scheme of a cannula adapter.

[0054] Figure 39E-Figure 39F Depicted showing Fig. 9 A side view of an example operating scheme of the cannula adapter.

[0055] Figure 40A-40C Depicted are example operational schemes for a cannula adapter having a spring drive system with a fillable reservoir.

[0056] Figure 41A-41B Depicted are example operational schemes for a fillable cannula adapter having a threaded plunger fluid delivery system with reverse flow.

[0057] Figure 42A-42B An example operational scheme of an embodiment of a primed elastomeric sleeve fluid delivery mechanism is depicted.

[0058] Figure 43A-43C Embodiments of peristaltic fluid transport mechanisms are depicted.

[0059] Fig.44 Various examples of inner catheter shapes and features for facilitating visualization are depicted, which may be incorporated into any embodiment of a cannula adapter.

[0060] Figure 45A-Figure 45B Depicted are example operations of a shape-setting cannula that may be incorporated into any embodiment of a cannula adapter.

[0061] Fig.46 An embodiment of a cannula having a notched distal tip to facilitate articulation is depicted, which can be incorporated into any embodiment of a cannula adapter.

[0062] Fig.47A A perspective view of another embodiment of a cannula adapter or fluid delivery device is depicted.

[0063] Fig.47B Depicted Fig.47AA perspective exploded view of the cannula adapter.

[0064] Figure 47C-Figure 47D Depicted Fig.47A Cross-sectional view of a cannula adapter.

[0065] Fig.47E Describes Fig.47D Indicated Fig.47A Magnified cross-sectional view of the cannula adapter.

[0066] Fig.47F Depicted Fig.47A An enlarged cross-sectional view of the end of the cannula adapter.

[0067] Figure 47G Depicted without locking pin Fig.47A Perspective view of a cannula adapter.

[0068] Figure 47H Depicted Figure 47G Cross-sectional view of a cannula adapter.

[0069] Figure 48A-Figure 48B Various views of an outer cannula that may be incorporated into any embodiment of a cannula adapter are depicted.

[0070] Figure 48C-Figure 48D Various views of an inner catheter that may be incorporated into any embodiment of a cannula adapter are depicted.

[0071] Figure 48E-48H Various views of an example of a distal tip of a cannula of a fluid delivery device are depicted.

[0072] Figure 49A-49B An example operational scheme of another embodiment of a cannula adapter is depicted.

[0073] Fig.50 Schematic examples of tips of ophthalmic devices are depicted.

[0074] Fig.51 Schematic examples of fluid flow from a tip of an ophthalmic device with and without a barrier are depicted.

[0075] Fig.52 Schematic examples of various extremities of ophthalmic devices are depicted.

[0076] Fig.53 A schematic illustration of a catheter having a fluid dispensing orifice and having a suture disposed within the catheter is depicted.

[0077] Fig.54 A schematic example of a catheter having a suture disposed on the exterior of the catheter is depicted.

[0078] Fig.55 Depicted is a schematic example of a suture bulb merged with a suture ring to form a suture loop.

[0079] Fig.56 and Fig.57 Schematic examples of suture structures are depicted.

[0080] Figure 58A-Figure 58D The steps for placing the guidewire and tensioning suture in the eye are depicted.

[0081] Fig.59 A push wire deployed from the catheter is depicted.

[0082] Fig.60A and Fig.60B Depicted are a front view and a perspective cross-sectional view of a tensioner deployed within a tube.

[0083] Fig.61 The tensioning device is depicted.

[0084] Figure 62A-62C The tensioner is depicted at different levels of contraction.

[0085] Figure 63A-Figure 63C Another tensioning device is depicted at different levels of contraction.

[0086] Fig.64 A perspective view of an ophthalmic device is depicted. DETAILED DESCRIPTION

[0087] The specific embodiments set forth below describe various configurations of the subject technology, and are not intended to represent the only configuration that can practice the subject technology. For the purpose of providing a thorough understanding of the subject technology, the specific embodiments include specific details. Therefore, the dimensions about certain aspects are provided as non-limiting examples. However, it is clear to those skilled in the art that the subject technology can be implemented without these specific details. In some cases, well-known structures and components are shown in block diagram form to avoid blurring the concept of the subject technology.

[0088] It should be understood that the present disclosure includes examples of the subject technology and does not limit the scope of the appended claims. Various aspects of the subject technology will now be disclosed according to specific but non-limiting examples. The various embodiments described in this disclosure can be carried out in different ways and variations and according to the desired application and implementation.

[0089] The ophthalmic device of the present disclosure comprises a syringe body having a proximal end and an opposite distal end with a hollow hole between the two ends. A plunger is disposed in the hollow hole and is coupled to a mechanism for providing a positive displacement of the plunger when actuated. The positive displacement mechanism allows a viscous material, particularly a viscoelastic material, to be delivered from the syringe body from the distal end with high precision. "Positive displacement" refers to applying force to the plunger and / or gradually limiting the linear translation of the plunger so as to provide a constant or gradually accurate, controllable material delivery from the distal end of the syringe body. The positive displacement mechanism can be configured to allow the plunger to be linearly translated stepwise in discontinuous increments to control delivery. The syringe body has a fluid outlet at the distal end, which can terminate at a connector, such as a Luer fitting for attaching a needle or cannula.

[0090] refer to Figure 1 In one embodiment of the ophthalmic device 3, a threaded rod 1 is attached to a plunger 6 at its distal end. The plunger 6 is located within a syringe body 4 having a proximal flange 8. A cap 5 is connected to the flange 8. Located at the proximal end of the rod 1 is a handle 2, which can be used as a thumbwheel to turn the rod to advance the plunger 6. A stopper 7 is located within the syringe body 4 to form an air tight seal when the force applied to advance the plunger acts on the viscous material within the syringe body. The viscous material is ejected through the distal end of the syringe body into a suitable receiving device.

[0091] refer to Figure 2In another embodiment of the ophthalmic device 10, a barrel 12 pre-filled with a viscoelastic material and including a rubber septum 22 at the distal end can be loaded into the syringe body 11 and then injected in a controlled manner using a screw mechanism including a threaded rod 18 attached to a distal plunger assembly 16 including a rubber stopper 23, a thrust bushing 20, and a plunger 19 that slideably moves within the syringe body 11. The ophthalmic device 10 includes a cap assembly 15 and a syringe body 11. The plunger 19 can have a seal such as an O-ring or a rubber flange (not shown) to help form a fluid tight seal between the plunger 19 and the syringe body 11. The threaded rod 18 extends out through a mating threaded aperture in the cap assembly 15 at the proximal end of the syringe body 11. The end of the rotating rod 18 advances the plunger 19 to eject the viscous material loaded within the barrel 12. The cap 15 can be removed to insert the pre-filled barrel 12 into the bore of the syringe body 11. The syringe body incorporates an internal needle 13 at the distal end of the ophthalmic device to penetrate into the barrel. The needle provides a flow path from the barrel to the male Luer fitting 14 located on the distal end of the ophthalmic device. A rubber diaphragm 22 provides a fluid tight seal of the barrel to the internal needle. An internal thrust bushing 20 and a rubber stopper 23 located at the end of the plunger assembly 16 meet the proximal end of the barrel 12. When the ophthalmic device handle 21 is rotated, the threaded rod 18 acts on the plunger assembly 16 to provide a positive displacement action to the barrel to deliver the barrel contents through the distal Luer fitting 14.

[0092] Due to the lack of compressible components, the use of a positive displacement mechanism ensures accurate and repeatable delivery characteristics. The ophthalmic device according to the present disclosure accurately delivers small increments (micro-amounts) of viscous fluids, typically in the range of 5 microliters to 25 microliters. The subject technology is particularly advantageous because it is difficult to deliver small amounts of viscous fluids when attempting to deliver through a small bore needle, microcannula, or microcatheter. Accurate delivery of small amounts of viscous fluids is particularly important in microsurgery, where fluids are used to expand or dissect delicate tissue structures.

[0093] Reference Figure 3 In another embodiment, the positive displacement mechanism includes a threaded rod 40 that attaches a syringe body plate 41 to a plunger plate 44 that is parallel thereto. Rotation of the rod 40 moves the plates 41 and 44 toward or away from each other. Attaching the plate 41 to the syringe body 42 and connecting the plate 44 to the plunger shaft 43 moves the plunger to allow precise control of the delivery of material from the syringe body.

[0094] In another embodiment, the positive displacement mechanism includes a plunger having a series of spaced mechanical stops having a predetermined spacing arranged to allow linear advancement of the plunger from one mechanical stop to the next mechanical stop. A release mechanism or additional advancement force may be utilized to continue advancing the plunger to the next stop. The amount of plunger translation allowed by each stop may be customized to set the precision of ophthalmic device delivery.

[0095] In another embodiment, the positive displacement mechanism is attached to a conventional syringe body, allowing it to be used with a variety of pre-packaged viscoelastic syringe kits. For example, the mechanism can be attached to a syringe flange and act on or replace a provided plunger. Thus, another feature is that the ophthalmic device can be provided in a kit including the ophthalmic device, one or more microcannulas for delivering material from the ophthalmic device to a surgical site, and / or a pre-packaged cartridge containing viscoelastic material useful in surgical or medical applications.

[0096] The ophthalmic device may be made of any suitable high strength material, such as metals and polymers. Preferred are materials that can be sterilized by conventional means, such as by autoclaving, treatment with ethylene oxide gas, or exposure to ionizing radiation. Suitable materials include metals such as steel and titanium, polymers such as polysulfone, polyethylene, nylon, polymethyl methacrylate, polyethylene terephthalate, polypropylene, and polycarbonate.

[0097] The ophthalmic device may also be used for rate-controlled delivery to precisely deliver viscous fluids at a slow and predetermined flow rate by maintaining a predetermined variable or constant injection pressure. When injected through a small-bore device (such as a microcannula or microcatheter) at a controlled injection pressure, the viscous fluid produces a constant or predetermined profile flow rate. Adjustment of the injection pressure measured at the output of the ophthalmic device or within the ophthalmic device allows the flow rate to be controlled. Reference Figure 4 , pressure regulation can be achieved by attaching a pressure gauge 36 or sensor to the ophthalmic device 35. Constant injection pressure can be maintained by manually controlling the positive displacement mechanism while monitoring the injection pressure, or alternatively by electrical feedback to a power actuator driving the injection mechanism. In alternative embodiments, pressure regulation can also be achieved by mechanical means by limiting the force applied by the positive displacement mechanism. For example, a clutch mechanism can be integrated into the screw drive mechanism to limit the maximum force applied to deliver the viscous material.

[0098] The ophthalmic device may also incorporate a pressure relief valve into the ophthalmic device to prevent overpressure or pressure spikes during viscous fluid delivery. The pressure relief valve may be comprised of a ball and spring assembly, wherein the ball is pressed against the orifice by the spring force until the injection pressure overcomes the spring force to allow fluid flow and pressure relief. The pressure relief valve may be designed to allow the user to adjust the maximum injection pressure.

[0099] The present disclosure includes a microcannula designed to be advanced into very small tissue spaces during surgery. In particular, for ophthalmic surgery, the microcannula can be used to insert into Schlemm's canal, aqueous humor collector channel, aqueous humor vein, retinal vein, and suprachoroidal space. The diameter of such structures ranges from 50 microns to 250 microns, thereby limiting the outer diameter of the microcannula to a similar size. Figure 6 As seen in the microcannula, the microcannula includes a flexible elongated element having a connector at a proximal end 53, a distal end, and a communication channel 51 therebetween. The communication channel 51 of the microcannula can be used to deliver fluids, materials, energy, gases, suction, surgical tools, and implants to a distal surgical site for various surgical tasks. The communication channel 51 can be a lumen of a sleeve-like elongated element for transmitting material, an optical fiber for transmitting light energy, or a wire for transmitting electrical signals. A flexible elongated element having a communication channel 51 is referred to as a communication element. A single communication element can have more than one communication channel.

[0100] The microcannula of the present disclosure incorporates specific design features, which enable it to be placed into very small tissue spaces. The key feature is the use of a composite microcannula design with an appropriate combination of axial stiffness and compliance. The microcannula is expected to be flexible to allow it to be advanced along a curved or tortuous tissue space while causing minimal trauma to the tissue, but with sufficient axial stiffness or "pusherability" to allow the transmission of force to advance the microcannula. For fixed external dimensions, the mechanical properties of the microcannula can be customized by selecting construction materials and cross-sectional dimensions. In one embodiment, a reinforcing element 52 is attached to the outside of the connecting element. Typically, the reinforcing element 52 includes a material with a higher flexural modulus than the connecting element. The connecting element can be a thin-walled polymer or a metal sleeve. The reinforcing element 52 can be formed of any high modulus material, such as but not limited to metals including stainless steel and nickel-titanium alloys, ceramic fibers and high modulus polymers, filled polymers or reinforced polymers, and polymer-polymer composites.

[0101] For optimal use in small tissue spaces, it is desirable that the microcannula be flexible at the distal tip but transition to more rigid mechanical properties toward the proximal end. The transition may include a gradient of compliance or one or more gradients of mechanical compliance along the length of the microcannula. The transition in mechanical properties may be achieved by varying the cross-sectional area or material properties of the microcannula along its length, incorporating one or more reinforcing members, or a combination thereof. In one embodiment of the present disclosure, the microcannula incorporates a connecting element 51 forming a connecting passage 51, the connecting element being made of a flexible polymer having two reinforcing members 54, 55 attached along the length, such as Figure 7 As seen in . One of the reinforcement members 55 extends along the connecting element, but does not extend completely to the distal end, while the other reinforcement member 54 extends completely to the distal end to provide a transition in flexural compliance. Reinforcement members 54, 55 can be formed by high modulus polymers or metals. In similar embodiments, a single reinforcement member (such as a tapered wire 52) with a flexural stiffness transition can be used to reinforce the connecting element. Alternatively, the reinforcement member can be formed by continuous segments of different moduli or cross-sectional sizes. The reinforcement element can be held in place by an outer sheath 56, which can include a tightly fitted polymer sleeve or a polymer heat shrink tubing. Alternatively, the reinforcement element can be adhered or bonded to the connecting element, or can be fully or partially contained in the connecting element.

[0102] The reinforcement element can also provide kink resistance to the communication element. This is particularly advantageous for use with communication elements made of high modulus polymers, such as polyimide, polysulfone, ultra-high molecular weight polyethylene and fiber-reinforced polymer composites, which can kink or deform under high loads, forming permanent mechanical defects. The reinforcement element can also include ductile materials to allow manual adjustment of the shape of the microcannula to better adapt to the curved shape of the tissue space. Possible ductile materials for the reinforcement element include, but are not limited to, steel, silver and platinum alloys.

[0103] like Figure 8 and Fig. 9As seen in , the reinforcement of the connecting element can also be achieved by combining a coil-like member to provide high flexural compliance and high axial stiffness to achieve pushability. The reinforcement members 57, 58 attached to the outer sheath can be coiled or wound elements located on the outer surface of the sheath or formed into the outer surface of the sheath. The reinforcement members 57, 58 can be any suitable high modulus material, including metals (such as but not limited to stainless steel, titanium and superelastic alloys), ceramics (such as ceramic fibers) and high modulus polymers or composite polymer structures (such as carbon fiber reinforced epoxy resin). The member can have any suitable cross-section, such as circular or semicircular or rectangular, as in the case of flat wire winding. The winding spacing of the reinforcement member can be constant or it can be variable to achieve different flexural characteristics along the length of the microcannula. Multiple winding elements can be combined, and these elements are formed by the same or different materials. The reinforcement element or multiple reinforcement elements can also be configured to provide a preferred deflection orientation of the microcannula.

[0104] The composite microcannula of the present disclosure may also include multiple connecting elements. In one embodiment, the microcannula may include two or more elongated connecting elements having reinforcing members to form a composite structure. These components may be adhered together and placed in an outer sheath (such as a heat shrink tubing), or the external connecting element may include one or more other connecting elements. One of the connecting elements may be used to transmit material and another to transmit light or energy, thereby providing a multifunctional surgical tool. The connecting elements may be aligned side by side or arranged around one or more reinforcing elements. In one embodiment, a connecting element having an annular cross-section forming a lumen may be assembled with a second connecting element in the lumen. Such concentrically aligned connecting elements may also be used in combination with other non-concentrically aligned connecting elements.

[0105] In a specific embodiment, the composite microcannula can be used only to transfer mechanical energy. For example, the microcannula can be used to advance into the tissue space and to capture foreign objects or tissue areas. In such cases, the elongated connecting element can be a material with appropriate mechanical properties, such as a wire, a polymer, or a fiber composite material. It is also possible to combine an internal member assembled in the connecting element and sliding in the connecting element, the internal member having at least a proximal end and a distal end. The advancement or withdrawal of the internal member can be used to change the shape of the distal end of the microcannula, or alternatively to achieve a mechanical effect at the distal end.

[0106] In one embodiment, the microcannula also includes a proximal connector for the communication element. The connector can be used to connect a supply source of material or energy (such as an infusion syringe or a light source) to the communication channel 51 of the communication element. In addition, the microcannula can include a central section, which includes a single-sided or multi-sided connector to allow attachment of auxiliary equipment, such as a syringe, a vacuum source or a pressure source, a sensing device, etc. The attachment connector can use a standard design, such as a Luer fitting, or can be designed to accept only a connection with a specific component. In another embodiment, a composite microcannula can be combined with perforations or windows along the length. The perforations can be used to transport materials from the side of the microcannula, such as delivering therapeutic agents to the tissue of Schlemm's canal. Alternatively, by connecting a vacuum generator to the proximal connector of the communication element, the perforations can be used to provide suction to soft tissue. The suction can be used to remove tissue, or can be used to anchor the microcannula in place while advancing another element through the microcannula. For example, a composite suction microcannula can be used to strip the juxtacanicular tissue from the inner wall of Schlemm's canal.

[0107] The connecting element can be formed by a thin-walled polymer or metal sleeve having sufficient rigidity to allow the connecting element to be advanced into the tissue or along a tissue space (such as Schlemm's canal) and having sufficient flexibility to follow the circular trajectory of Schlemm's canal. Due to the small size of the target tissue space, the microcannula must be of a suitable size. Typically, the outer diameter of the microcannula is in the range of 50 microns to 350 microns, with a wall thickness of 10-100 microns. The cross-section of the microcannula can be circular or elliptical or other shapes to approximate the shape of a tissue space (such as Schlemm's canal). In some embodiments, a predetermined curvature can be applied to the device during the manufacturing process.

[0108] Suitable materials for the communication element include metal, polyetheretherketone (PEEK), polyethylene, polypropylene, polyimide, polyamide, polysulfone, polyether block amide (PEBAX), fluoropolymer or similar materials. The outer sheath may also have a surface treatment, such as a lubricating coating that helps tissue penetration and an ultrasonic or optically interactive coating that helps positioning and guiding. The microcannula may also have a mark on the outside for assessing the depth in the tissue space. For example, the mark may take the form of a ring around the outer shaft, positioned at regular intervals along the length of the microcannula. External markings allow the user to assess the length of the tissue space or passageway entered by the microcannula and the approximate position of the microcannula end.

[0109] In an embodiment of the present disclosure, the first communication element used for initial placement of the microcannula has a signal beacon to identify the position of the distal tip of the microcannula relative to the target tissue, such as Fig.10As seen in . The signal device may include an echogenic material for ultrasound guidance, an optically active material for optical guidance, or a light source for visual guidance, which is placed at the end of the microcannula or is placed to indicate the position of the microcannula end. In one embodiment, a plastic optical fiber (POF) 59 is used as a connecting element to provide a bright visual light source at the distal end 60. The distal end 60 of the POF 59 is positioned to be located proximal to, near, or slightly beyond the distal end of the microcannula sheath, and the emitted signal can be detected visually through the tissue or using a sensing device (such as infrared imaging). The POF 59 can also have an inclined, mirrored, or otherwise configured end to provide a directional beacon. The beacon can be illuminated by a laser, a laser diode, a light emitting diode, or an incandescent light source (such as a mercury halide lamp). In an alternative embodiment, the signal device can include a visualization aid along the length of the microcannula, for example, a side-emitting optical fiber with a discrete length leading to the distal end or along a known point of the microcannula can be used to indicate the position of the microcannula and the distal end. When the microcannula is placed at the target tissue, the beacon assembly 61 and POF 59 can be removed. The connection point can be sealed with a cap or with a self-sealing mechanism (such as a one-way valve or an elastomeric seal). Alternatively, the POF can be placed in line with or within the lumen of the delivery communication channel, allowing fluid or gas to be delivered through the delivery communication channel without removing the beacon assembly.

[0110] Alternative embodiments of the microcannula may use other imaging techniques to locate the signal beacon. Other possible imaging techniques include, but are not limited to, magnetic resonance imaging, fluoroscopy, and ultrasound. In these embodiments, the beacon signal may take other forms to match the imaging technique, such as a radiopaque marker attached to the distal end of the microcannula or embedded at or near the distal end of the microcannula. Alternatively or additionally, an echogenic material or coating may be added to the distal end, and the like.

[0111] The microcannula also preferably has a rounded distal tip 62 to minimize tissue trauma and to facilitate the ability of the microcannula to be advanced into small tissue spaces, such as Fig.11 and Fig.12 . The outer diameter of the rounded tip 62 can be the same as or larger than the microcannula, depending on the specific characteristics desired. The rounded tip 62 can be formed during assembly and attached to the microcannula, or alternatively, the microcannula tip can be machined in a secondary operation to form a rounded profile. When the rounded tip 62 is used in conjunction with the light emitting signal beacon 59 so that light is delivered proximally to the rounded tip, the tip acts to disperse light 63. When the microcannula is viewed off-axis, such as when advancing the microcannula in Schlemm's canal, the dispersed light aids in visualization.

[0112] Another key feature of the present disclosure is that a connecting element is used to deliver fluid to the distal end during the process of advancing the microcannula in the tissue space. Injecting a small amount of fluid can be used to open the tissue space in front of the microcannula end and lubricate the channel, thereby greatly improving the ability to advance the microcannula without trauma. Delivery of surgical viscoelastic materials (such as hyaluronic acid solutions and gels) is particularly effective in helping to advance and place the microcannula. In the case of contraction or partial blockage during the advancement of the microcannula, the delivery of fluid (especially gel-like viscoelastic materials) allows the tissue space to be expanded. Particularly effective embodiments include a microcannula having a connecting element (such as an optical fiber) that provides a signal beacon at the microcannula end and a second connecting element that delivers fluid (such as a solution of hyaluronic acid) to the microcannula end when the signal beacon is activated. Such microcannula can be manually manipulated and used to deliver fluid to help advance the microcannula while observing the position of the microcannula end along the tissue space. The combination of delivering fluid in the path of the microcannula and observing the microcannula end when advancing, retracting and twisting the microcannula end allows for precise control of manipulation and advancement in a small tissue space. Adding reinforcement members to the communicating elements of the microcannula further aids in ease of manipulation.

[0113] Described herein is a system and method for entering Schlemm's canal and for conveying an ocular device and / or a fluid composition therein to reduce intraocular pressure and thereby treat eye disorders. Certain parts of fluid and system (e.g., slidable conduit) can be used to provide the power of destroying trabeculocanalicular tissue, which includes trabecular meshwork, paracanalicular tissue, Schlemm's canal, and collector channel. As used herein, the term "destruction" refers to conveying a certain volume of fluid or system components that changes tissue in a manner that improves the flow through the trabeculocanalicular outflow path. Examples of tissue destruction include, but are not limited to, the expansion of Schlemm's canal, the expansion of collector channel, the porosity of the trabeculocanalicular meshwork, stretching the trabeculocanalicular meshwork, forming microtears in paracanalicular tissue, removing diaphragms from Schlemm's canal, cutting or removing trabeculocanalicular tissue or a combination thereof.

[0114] To better understand the systems and methods described herein, it may be useful to explain some basic eye anatomy. Fig.131 is a stylized depiction of a normal human eye 115. The anterior chamber 100 is shown as being bounded on its anterior surface by the cornea 102. The cornea 102 is connected at its periphery to the sclera 104, which is a tough fibrous tissue that forms the white shell of the eye 115. The trabecular meshwork 106 is located at 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 trabecular meshwork 106. Angle 112 is located at the vertex formed between the iris 110, the trabecular meshwork 106, and the sclera 104.

[0115] The system is typically configured for one-handed manipulation and control by a single operator, and includes one or more features for easily entering Schlemm's canal with minimal trauma. Once access to the canal has been obtained, the system can deliver an ocular device, a fluid composition, or both. In some variations, the system advances a tool that destroys Schlemm's canal and surrounding tissue without delivering an ocular device or a fluid composition. For example, the tool can be a conduit that is slidable in and can extend from a cannula for accessing the cannula, and its outer diameter is sized to destroy the cannula and surrounding tissue. The distal end of the conduit can also be provided with a destructive component to help destroy the trabecular tubular tissue.

[0116] The device implanted in Schlemm's canal will generally be configured to maintain the openness of the canal without substantially interfering with the cross-wall fluid flow through the canal. An ocular implant can be delivered. In some variations, the implant includes a support member having at least one perforation that completely spans the central core of Schlemm's canal without substantially interfering with the cross-wall fluid flow or longitudinal fluid flow through or along the canal. The ocular device may also destroy the paratubular trabecular meshwork or the adjacent inner wall of Schlemm's canal. The ocular device may also be coated with a drug for treating high intraocular pressure, glaucoma or pre-glaucoma, infection, or postoperative inflammation or scarring. The ocular device may also be formed as solid, semisolid, or bioabsorbable.

[0117] The system can also be used to deliver fluid compositions, such as saline or viscoelastic fluids. Saline can be used for irrigation. Viscoelastic fluids can be used in the endo-version of viscocanalostomy or canaloplasty to disrupt the tube and surrounding tissue.

[0118] The system described herein can be a one-hand, single operator controlled device, which generally includes a universal handle having a grip portion and a housing having an interior and a distal end. The cannula is generally coupled to the housing distal end and extends from the housing distal end. The cannula may include a proximal end and a distal curved portion, wherein the distal curved portion has a proximal end and a distal end and a radius of curvature defined between the ends. The cannula may also be configured to include: a body; a distal end having a bevel; and a lumen extending from the proximal end through the distal end. The bevel may directly engage the distal end of the curved portion of the cannula (i.e., the bevel may directly engage the radius of curvature). The system may also generally include a drive assembly partially contained within the housing, the drive assembly including a gear that converts a rotary motion into a linear motion. When the ocular device is to be implanted in Schlemm's canal, the system may further include a slidable positioning element having a proximal end and a distal end coaxially arranged within the cannula lumen. When the fluid composition is delivered to Schlemm's canal, the system can also be configured to include a fluid assembly in the handle and a slidable pipeline coaxially arranged in the cannula lumen. The system can be used to deliver fluid compositions such as saline, viscoelastic fluids including viscoelastic solutions, air and gas. Suitable markings, colors or indicators can be included in any part of the system to help identify the position or location of the distal end of the cannula, a positioning element, a coupling mechanism, an ocular device or a slidable pipeline.

[0119] The ocular delivery system described herein may include a universal handle that can be used with one hand. For example, the handle can be configured to be used with the right hand in one orientation, and then the handle can be used with the left hand by simply flipping the handle (or by rotating the cannula itself 180 degrees) to a second orientation. The handle generally includes a gripping portion and a housing. The gripping portion may be raised, recessed or grooved in certain areas, or have a texture to improve the user's grip on the handle or to improve the user's comfort. The housing may include an inner portion and a distal end. The inner portion of the housing may include a drive assembly and a locating element (the drive assembly and locating element are further described below). In some variations, the distal end of the housing includes a fluid port that can provide a fluid for irrigating the surgical field or clearing air from the system.

[0120] The universal handle can be made of any suitable material, including but not limited to: fluoropolymers; thermoplastics such as polyetheretherketone, polyethylene, polyethylene terephthalate, polyurethane, nylon, etc.; and silicone. In some variations, the housing or a portion thereof can be made of a transparent material. Materials with suitable transparency are typically polymers such as acrylic copolymers, acrylonitrile butadiene styrene (ABS), polycarbonate, polystyrene, polyvinyl chloride (PVC), polyethylene terephthalate glycol (PETG), and styrene acrylonitrile (SAN). Acrylic copolymers that may be particularly useful include but are not limited to polymethyl methacrylate (PMMA) copolymers and styrene methyl methacrylate (SMMA) copolymers (e.g., Zylar Acrylic acid copolymer).

[0121] The length of the universal handle can generally be between about 4 inches (10.2 cm) and 10 inches (25.4 cm). In some variations, the length of the universal handle is about 7 inches (17.8 cm).

[0122] The cannula of the ocular delivery system is typically coupled to and extends from the distal end of the housing, and is typically configured to provide easy and minimally invasive access to Schlemm's canal using a minimally invasive intra-canalicular approach. Some variations of the cannula may include a proximal end and a distal curved portion, wherein the distal curved portion has a proximal end and a distal end and a radius of curvature defined between the ends. The cannula may also be configured to include: a body; a distal end having a bevel; and a lumen extending from the proximal end through the distal end. The bevel may directly engage the distal end of the curved portion of the cannula (i.e., the bevel may directly engage the radius of curvature).

[0123] The cannula can be made of any suitable material having sufficient rigidity to allow the cannula to be advanced through the eye wall and anterior chamber. For example, the cannula can be made of metal (such as stainless steel, nickel, titanium, aluminum or alloys thereof (e.g. The cannula may be formed of a polyvinyl alcohol, a polyvinyl alcohol (PEEK), ... )) and polyethylene oxide.

[0124] The outer diameter of the cannula is typically sized to obtain access to the lumen of Schlemm's canal while minimizing obstruction to the surgeon's field of view. Thus, the outer diameter may range from about 150 microns to about 800 microns. The cannula also has an inner diameter that may range from about 50 microns to about 400 microns. The cannula may also be formed to have any suitable cross-sectional profile, such as circular, oval, triangular, square, rectangular, etc.

[0125] The cannula can be configured to include multiple parts or parts. A cannula having the following arrangement may be particularly useful for entering the lumen of Schlemm's canal, the cannula having: a body; a distal curved portion having a proximal end and a distal end, a radius of curvature defined between the ends; and a chamfer at the distal end of the cannula that directly engages the distal end of the curved portion of the cannula. Here, the body (the straight portion of the cannula) can have a length ranging from about 5mm to about 50mm, about 10mm to about 30mm, or from about 14mm to about 20mm. In some variations, the body can have a length of about 18mm. The cross-sectional shape of the distal curved portion of the cannula can be uniform, or it can taper closer to the distal end to facilitate entry into Schlemm's canal. The radius of curvature of the distal curved portion can be suitable for facilitating tangential entry into Schlemm's canal and accurate and minimally traumatic entry into Schlemm's canal, and can range from about 1mm to about 10mm or from about 2mm to about 5mm. In one variation, the radius of curvature is about 2.5 mm. The cannula may also have an angular span suitable for facilitating entry into Schlemm's canal and may range from about 70 degrees to about 170 degrees or about 100 degrees to about 150 degrees. In one variation, the angular span is about 120 degrees.

[0126] The size, shape, geometry, etc. of the chamfer at the distal end of the curved portion of the cannula can be beneficial to allow easy and minimally invasive access to Schlemm's canal. In this regard, and as described in further detail below, a chamfer having a radius of curvature that directly engages the distal end of the cannula can be particularly useful.

[0127] In other variations, the cannula may include a short straight segment (e.g., at the end of a radius of curvature) that is coupled to the distal end of the distal curved portion of the cannula. Here, the bevel engages the straight segment, rather than the radius of curvature. The length of the straight segment may range from about 0.5 mm to about 5 mm. In some variations, the length of the straight segment ranges from about 0.5 mm to about 3 mm or from about 0.5 mm to about 1 mm. The length of the straight segment may also be less than about 0.5 mm, for example, the length of the straight segment may be about 0.1 mm, about 0.2 mm, about 0.3 mm, or about 0.4 mm. In variations where the bevel directly engages the distal end of the curved portion of the cannula (i.e., the bevel directly engages the radius of curvature), the cannula lacks a straight segment (the length of the straight segment is zero).

[0128] It may also be useful to have a sharp and short bevel to minimize the distance any ocular device must travel when implanted in the tube. Exemplary bevel angles may range from about 10 degrees to about 90 degrees. In one variation, the bevel angle is about 35 degrees. The bevel may also be oriented in a suitable direction. For example, the bevel may be oriented so that the bevel opens toward the surgeon, or the bevel may be inverted to open away from the surgeon, or the bevel may be located in any plane in between.

[0129] In yet another variation, the cannula is configured to include one sharp section and another blunt (e.g., deburred) section. Such a dual-surface configuration of the cannula may be advantageous because it may provide easier access to the tube by piercing the reticular tissue while also providing a gentle, dispersive force on the tube during retraction of the tube into the cannula to avoid cutting or rupturing the tube due to the retraction force. For example, Fig. 27 As shown, the distal end of the cannula 1500 can have a sharp piercing tip 1502 and a smooth edge 1504 that define an opening portion 1506 through which the tube ( Fig.28 ) can be advanced and retracted. The sharp end 1502 can be formed by compounding multiple bevels. The smooth edge 1504 can be produced by laser ablation or deburring the inner bevel edge.

[0130] The drive assembly of the delivery system is generally configured to move the ocular device, pipeline and / or fluid composition out of the universal handle and into Schlemm's canal. The drive assembly can also be configured to position the ocular device in the tube, including advancing the device into the tube and retracting the device from the tube. The drive assembly can be at least partially contained in the housing, and can include any suitable components or combinations of components that can provide universal functions for the handle. In some variations, the drive assembly includes a component that converts rotary motion into linear motion. For example, the drive assembly can include a linear gear and a pair of pinion mechanisms. The linear gear can have teeth on its surface that mesh with corresponding teeth on the pinion. Each of the pinion mechanisms can also be coupled to a rotatable component (e.g., a wheel). Such coupling can be achieved by a pin and a nut, and the pin can be screwed through the central opening in the rotatable component and the pinion, and the nut fixes the rotatable component and the pinion in a way that the rotation of the rotatable component also causes the pinion to rotate, and vice versa. The wheel can be attached to the pinion by one of the following methods: 1) the wheel and pinion are molded as one part using plastic injection molding technology; 2) the wheel slides onto the pinion and is fixed with an adhesive; or 3) the wheel slides on the pinion and is mechanically fixed with fasteners or "press fit", where the wheel is pressed onto the pinion and friction fixes them. In all mentioned cases, the wheel and the pinion can rotate coaxially, in the same direction and at the same angular velocity. In some variations, each of the pinion mechanisms is connected to at least two rotatable components. In other variations, the drive assembly can be configured to include a single rotatable component, multiple rotatable components, or no rotatable components. The wheel can have markings or colors to indicate the degree of propulsion or the direction of propulsion.

[0131] A variation of a drive assembly for inclusion in a universal handle includes a linear gear, a pair of pinion mechanisms, and two rotatable components (four rotatable components in total) coupled to each pinion. Here, the pinion mechanism and the associated wheels will be disposed on both sides of the linear gear. The pinion and the linear gear will contact each other, i.e., the teeth of the pinion will directly engage the corresponding teeth on the linear gear, and the wheel on one side of the linear gear will contact the wheel on the opposite side of the linear gear. In this variation, the drive assembly can be manipulated with one hand when in a first configuration, and then the drive assembly can be manipulated with the other hand when flipped to a second configuration. A right-handed or left-handed surgeon can easily use a drive assembly with such flexible capabilities. In a further variation, the drive assembly can include a rotatable component on one side of the handle and a "universal" feature of a handle provided by a cannula that can rotate itself rather than by flipping the handle.

[0132] One or both pinion gear mechanisms can be disengaged from the linear gear by biasing their position away from the axis of the linear gear. This action causes the pinion gear teeth to separate from the linear gear teeth to prevent the linear gear from moving. The pinion gear mechanism can also be locked to prevent rotation by engaging a cross pin or feature that prevents the wheel from rotating.

[0133] In other variations, the drive assembly includes a linear gear and a single pinion mechanism with two associated wheels. Further variations of the drive assembly may not employ the conversion of rotational motion to linear motion. For example, a slide (e.g., a finger slide) on the handle may be used to deliver an ocular device or fluid composition, the slide being fixedly or removably coupled to a gear (e.g., the aforementioned linear gear) within the handle housing. Here, the drive assembly may be configured such that advancement of the slide correspondingly advances the components that deliver the ocular device or fluid composition to Schlemm's canal, and retraction of the slide correspondingly retracts those components. In yet other variations, a button that can be pressed with one finger or squeezed with two fingers may be employed in place of the slide.

[0134] The ocular delivery system may further include a slidable positioning element coaxially disposed within the cannula lumen for controlled implantation of the ocular device in Schlemm's canal. The positioning element typically includes a proximal end, a distal end, and an engagement mechanism at the distal end. The ocular device is typically releasably coupled to the engagement mechanism. The positioning element may be advanced to deploy the ocular device within the cannula into Schlemm's canal, or the positioning element may be retracted to facilitate positioning and / or repositioning of the ocular device, or to disengage the ocular device from the engagement mechanism.

[0135] Some variations of the engagement mechanism include a proximal coiled portion and a distal hook. When an implant having at least one perforation (e.g., a proximal perforation) is to be implanted, the hook can be releasably engaged to the perforation. The ocular device can be disengaged from the hook by applying a gentle force on the coil or by another component that can be advanced on the coil to push the device away from the hook or by using a shape memory material that passively disengages when the cannula is withdrawn. The use of the hook may be advantageous when the ocular device needs to be retracted. The surgeon can simply move the delivery system and engagement mechanism so that it disengages from any perforation or notch on the implant.

[0136] In another variation, the engagement mechanism includes opposing jaws. Here, the engagement mechanism may include a first jaw and a second jaw, wherein the jaws have a closed configuration and an open configuration. The jaws can be used to clamp and manipulate the ocular device, and the ocular device is releasably connected to the positioning element. The jaws can be formed by splitting or bifurcating the distal end of the wire (e.g., by laser cutting). The gripping force of the jaws can be achieved by constraining the jaws within the cannula. Once the jaws are advanced outside the cannula and expanded, the ocular device can be released. The jaws can also be pivotally connected. In yet another variation, the first jaw may include at least one tine, and the second jaw may include at least one aperture for receiving the tine when the jaws are in a closed configuration.

[0137] In a further variation, the engagement mechanism includes an annular portion. This variation of the engagement mechanism will typically be used with an ocular device that includes a spring-like clasp at its proximal end, wherein the clasp has a collapsed configuration and an expanded configuration. The clasp is typically made to be in an expanded position. Thus, when the device with the clasp is disposed within the cannula, the first and second arms or tabs of the clasp can collapse around the annular portion of the engagement mechanism. Once the clasping portion of the device is withdrawn from the cannula, the arms or tabs can expand to release the ocular device from the annular portion.

[0138] Another variation of the engagement mechanism includes a female-to-male interface. For example, the engagement mechanism may include a notch configured to engage with a complementary mating element (e.g., a tab) on the ocular device. The notch (female component) may be formed within the subcutaneous injection tubing, or may be made by generating a perforation through the distal end of a positioning element made of a solid wire or element, and the tab or hook (male component) may be formed as part of the ocular device and may be inserted into the perforation or notch in the positioning element. With this configuration, the ocular device may be released from the positioning element when the ocular device is advanced out of the cannula, either by manipulation by the surgeon, or by shape setting of the positioning element (which causes the positioning element to be passively separated from the ocular device), or by both.

[0139] When the fluid composition is delivered to Schlemm's canal, the system generally includes a reservoir. As further described below, the reservoir can be at least partially defined by the linear gear in the fluid assembly and the housing and the handle. The fluid assembly can be made of any suitable material for the cannula and the housing mentioned above. The volume (in microliters) of the fluid contained in the reservoir can range from about 2 μl to about 1000 μl or from about 2 μl to about 500 μl. In some variations, the range of the reservoir volume can be from about 50 μl to about 100 μl. Some variations of the fluid assembly include a locking mechanism for preventing the assembly from moving in the handle (for example, when the linear gear is advanced or retracted). The locking mechanism can include a ratchet pawl, a combination of ratchet pawls, or any other suitable mechanism, which can be locked to prevent the movement of the fluid assembly and can be unlocked to allow the movement of the fluid assembly.

[0140] Fluid composition can be pre-loaded in the reservoir, or before using the system, for example, when eye surgery begins, fluid composition is loaded into the reservoir so that fluid can be delivered by a single device and a single user. Similarly, this is contrasted with other systems using tweezers or other propulsion tools to propel fluid delivery conduit into Schlemm's canal and / or the device comprising viscoelastic fluid (the device is separated or independent from delivery conduit or conduit propulsion tool, and needs to be connected to delivery conduit or conduit propulsion tool by, for example, assistant or by the hand of the surgeon during surgery, and delivery conduit or conduit propulsion tool is held by the other hand of the surgeon). For example, a loading component can be provided on the fluid assembly for fluid composition to be delivered into the reservoir. The loading component can have any suitable configuration, and the configuration provides a reversible fixation of a fluid reservoir (for example, a syringe, a barrel, etc.) to the system, and fluid composition is loaded into the reservoir. The loading component can be a Luer fitting or includes a one-way valve. The slidable pipeline coaxially arranged in the cannula lumen can be operably connected to the reservoir for fluid composition to be delivered into Schlemm's canal. Slidable conduit usually has a proximal end, a distal end and limits the wall of the conduit lumen extending therethrough. However, in some cases, the delivery system lacks a slidable conduit, and the fluid composition is only delivered by intubation. In other cases, two slidable conduits can be adopted, and these two slidable conduits are simultaneously advanced through the tube in clockwise and counterclockwise directions respectively, to insert Schlemm's canal more quickly and to deliver treatment. As previously mentioned, fluid can be delivered with a certain volume, and this certain volume provides enough force to destroy Schlemm's canal and surrounding trabecular tubule tissue. Exemplary destructive volume can be about 1 μ l, about 2 μ l, about 3 μ l, about 4 μ l, about 5 μ l, about 6 μ l, about 7 μ l, about 8 μ l, about 9 μ l, about 10 μ l, about 11 μ l, about 12 μ l, about 13 μ l, about 14 μ l, about 15 μ l, about 16 μ l, about 17 μ l, about 18 μ l, about 19 μ l or about 20 μ l. In some variations, the disruptive volume of fluid may range from about 1 μl to about 50 μl or from about 20 μl to about 50 μl.

[0141] The slidable conduit can be made of any suitable material that imparts the desired flexibility and pushability for introduction through the eye wall, into Schlemm's canal and / or through other ocular tissue structures. For example, the conduit can include: a polymer; a polymer reinforced with a metal wire, braid or coil; a composite material of a polymer and a metal; or a metal, such as stainless steel, titanium, nitinol or an alloy thereof. The slidable conduit can be linear, with sufficient flexibility and pushability to pass through the annular Schlemm's canal, or can be preformed to a radius of curvature of about 2-10 mm or a radius of curvature of about 6 mm (i.e., the approximate radius of curvature of Schlemm's canal in an adult) to more easily bypass the Schlemm's canal in part or in its entirety. In some other variations, the slidable conduit includes a plurality of openings through its wall that are spaced apart along the axial length of the conduit. In this variation, the fluid composition can be transported from a reservoir through the opening in the conduit and transported into the Schlemm's canal. This lateral injection of fluid (e.g., viscoelastic fluid) will further enhance the destruction of outflow tissue, and enhance the permeability to aqueous humor. It should be understood that the opening can have any suitable number, size, and shape, and is separated in any suitable manner along the axial length (including the distal end) of the pipeline. In other variations, the distal end of the slidable pipeline can be configured or modified to help deliver the fluid composition to Schlemm's canal. For example, the distal end of the pipeline can include a cut configured as a half sleeve. The distal end of the pipeline can also be configured as a blunt bevel, an anti-traumatic end, an amplified anti-traumatic end, or a rough surface of the juxtatrabecular part or the trabecular meshwork of the Schlemm's canal. In addition, the pipeline can have one or more projections derived from the pipeline to further destroy the juxtatrabecular part or the trabecular meshwork of Schlemm's canal, and therefore increase the permeability of aqueous humor into Schlemm's canal through the trabecular meshwork. In some cases, the pipeline can also deliver energy to the trabecular tubular tissue. In other cases, the pipeline can be a readily available commercially available or customized polypropylene suture (or other material). The suture can be sized so that it can be advanced through the cannula and advanced into a portion of Schlemm's canal (e.g., 0 to 360 degrees of the canal) to destroy the canal, support the canal, and / or apply tension to the canal and / or tear the trabecular canal tissue. The exemplary range of suture size can be from about 50 microns to about 300 microns. The suture can be removed from the canal or left in the canal to continuously deliver tension on the net and maintain the openness of the canal.

[0142] The cannula of the system described herein can also be delivered various surgical tools by the inner road method. For example, catheters, wires, probes and other tools can also be used to enter Schlemm's canal from the inner road, and then form holes, partial thickness destruction or penetration at discrete positions or all along the inner wall of the trabecular meshwork or Schlemm's canal. The surgeon can also always advance the tool to pass through the tube and through the outer wall of the collector channel to approach the sclera and subconjunctival space (all from the inner road approach), to form an incision or to deliver an eye device from the inner road, the incision forms a scleral lake, wherein aqueous humor can be discharged to the scleral vein or the subconjunctival space, which resides and drains to the scleral lake or the subconjunctival space from the anterior chamber or Schlemm's canal.

[0143] The reservoir may contain various fluid compositions for delivery to Schlemm's canal. Exemplary fluid compositions include saline and viscoelastic fluids. The viscoelastic fluid may include hyaluronic acid, chondroitin sulfate, cellulose, derivatives or mixtures thereof, or solutions thereof. In one variation, the viscoelastic fluid includes sodium hyaluronate. In another variation, the viscoelastic composition may further include a drug. For example, the viscoelastic composition may include a drug suitable for treating glaucoma, alleviating or reducing intraocular pressure, alleviating inflammation, and / or preventing infection. Drugs such as antimetabolites, steroids, heparin, other anticoagulants, and fibrinolytic compounds may also be delivered with the viscoelastic composition. Examples of glaucoma drugs include prostaglandins, beta-blockers, miotics, alpha adrenergic agonists, or carbonic anhydrase inhibitors. Anti-inflammatory drugs such as corticosteroids or other steroids may be used. For example, steroids such as prednisolone, prednisone, cortisone, cortisol, triamcinolone acetonide, or short-acting steroids may be used. Examples of antimetabolites include 5-fluorouracil or mitomycin C. In another variation, the system delivers only the drug without the viscoelastic composition. Saline solution may also be an employed fluid.

[0144] In other variations, the device / system may include a slidable conduit that does not convey fluid, but the slidable conduit is sized to have an outer diameter sufficient to destroy Schlemm's canal and surrounding trabecular tubular tissue. The outer diameter may range from about 50 microns to about 500 microns, from about 300 microns to about 500 microns, from about 200 microns to about 250 microns, or from about 180 microns to about 300 microns. In some cases, it may be beneficial for the conduit to have an outer diameter of about 240 microns. In addition, the distal portion of the conduit may include a destructive component, such as a notch, a hook, a barb, or a combination thereof, to destroy tissue.

[0145] Exemplary ocular delivery systems are Fig.14200 is depicted in FIG. In this figure, the delivery system 200 includes a universal handle 202 having a grip portion 204 and a housing 206. The housing has a proximal end 208 and a distal end 210. A cannula 212 is coupled to and extends from the housing distal end 210. A drive assembly 214 is substantially contained within the housing 206, which actuates the movement of a positioning element (not shown). A port 216 is disposed on the distal end of the housing 210 for removably connecting to a source of irrigation fluid.

[0146] The cannula of the exemplary delivery system is Fig.15 306. Here, the cannula 300 includes a proximal end 302, a distal curved portion 304, a body 314, and a distal tip 306. The distal curved portion 304 has a proximal end 308 and a distal end 310 and a radius of curvature R defined between the ends 308, 310. The bevel 312 at the distal tip 306 directly engages the distal end 310 of the curved portion of the cannula. In other words, the bevel 312 can be adjacent to the distal end 310 of the curved portion of the cannula. As previously described, this configuration of the distal curved portion 304 and the bevel 312 is beneficial or advantageous for allowing easy, atraumatic and controlled access to Schlemm's canal. The angle of the bevel is also very important. Generally speaking, a short bevel may be beneficial. Here, the bevel angle A is about 35 degrees.

[0147] The ocular delivery system generally includes a drive assembly substantially contained within a housing. Fig.16A In the variation shown, the delivery system 400 includes a drive assembly 402 having a linear gear 404 (e.g., a rack) and a pair of pinion mechanisms 406. Both the linear gear and the pinion mechanism have teeth that engage with each other to convert the rotational motion (of the pinion mechanism 406) into the linear motion (of the linear gear 404). Each of the pinion mechanisms 406 is coupled to two rotatable components, shown as wheels 408 in the figure, for a total of four rotatable components. The wheels 408 can be rotated by one or more fingers of the surgeon to correspondingly rotate the pinion mechanism 406 and thereby advance or retract the linear gear 404. The wheels 408 are coaxial with the pinion mechanism 406 and rotate in unison with the pinion mechanism. The movement of the linear gear 404 advances or retracts a positioning element 410 that is coaxially disposed within a cannula 412 and is slidable within the cannula. Fig. 16B Shown in a second flipped orientation Fig.16A system that can be used by the opposite hand (for example, if Fig.16A The system is used by the right hand, then Fig. 16B system is used with the left hand), or the system can be used with the same hand but requires a different cannulation orientation (e.g., if the Fig.16A The system in the performs counterclockwise intubation, then Fig. 16B The system in Figure 1 is cannulated clockwise).

[0148] When the delivery system is used to implant an ocular device, the cannula may have a slidable positioning element coaxially disposed in the lumen of the cannula. The slidable positioning element typically includes an engagement mechanism for manipulating (e.g., releasably engaging, advancing, and / or retracting) the ocular device. An exemplary engagement mechanism is shown in FIG. Fig.21 Described in .

[0149] exist Fig.17A In the embodiment, the engagement mechanism 500 includes a first jaw 502 and a second jaw 504. In their closed configuration (eg, Fig.17A ), the jaws 502, 504 are constrained within the cannula 512 and hold an ocular device 506 including a support 508 and at least one perforation 510. When the jaws 502, 504 are advanced out of the cannula 512, they are no longer constrained and thus assume the form of an open configuration of the jaws, as shown in FIG. Fig. 17B . Opening of the jaws 502, 504 releases the ocular device 506 from the engagement mechanism 500. At least one tine 514 may be provided in the first jaw 502 and at least one aperture 516 may be provided in the second jaw 504 to aid in securing the perforated ocular device when the jaws are in their closed configuration. Fig.18 , a variation of the engagement mechanism 600 is shown in which the first jaw 602 and the second jaw 604 include tines 606 and apertures 608 to aid in grasping a perforated ocular device 610 .

[0150] refer to Figure 19A-19B , depicting further exemplary engagement mechanisms. Fig.19A In the embodiment of the present invention, the engagement mechanism 700 includes complementary mating elements.

[0151] Specifically, engagement mechanism 700 includes a female element (recess 702) configured to interface with a complementary male element 704, shown as a hook-like protrusion on an ocular device 706. Here, recess 702 may be made at the end of a hypodermic cannula 708 (which will serve as a locating element). Instead of recess 702, the female element of engagement mechanism 710 may include an opening 712, such as Fig.19B As shown, it engages with the male component 704 on the eye device 706. Fig.19B In the embodiment of the present invention, the positioning element 714 can be made of a metal wire or rod, and the opening 712 is formed via laser processing or other processes known in the art.

[0152] In other variations, the engagement mechanism may be configured as Fig. 20A and Fig. 20BIn those figures, engagement mechanism 800 includes an annular portion 802. It may be beneficial to use this particular engagement mechanism with an ocular device 804 that includes a clasp 806 having arms or tabs 808 that have a closed configuration and an expanded configuration. Fig.17A and Fig. 17B , before the tab 808 is advanced out of the cannula 810, the tab is constrained within the cannula 810 in its closed configuration. In its constrained configuration, the tab 808 engages the annular portion 802 of the engagement mechanism 800 to prevent the ocular device 804 from being released from the system. When the annular portion 802 of the engagement mechanism 800 is advanced sufficiently that the tab 808 is no longer constrained by the cannula 810, the tab 808 assumes its expanded configuration, thereby releasing the ocular device 804 from the annular portion 802 and into Schlemm's canal, as shown in FIG. Fig. 20B shown.

[0153] Another exemplary engagement mechanism 900 is Fig.21 904. The ocular device 906 is shown in FIG. 1 , which includes a coiled portion 902 and a hook portion 904. When an ocular device 906 having at least one perforation 908 (e.g., a proximal perforation) is to be implanted, the hook portion 904 may be releasably engaged to the perforation 908. The ocular device 906 may be disengaged from the hook portion by applying a gentle force on the coil 902 or by another component (not shown) that may be advanced on the coil 902 to push the device 906 away from the hook portion 904. Using the hook portion 904 may be advantageous when it is desired to retract the ocular device 906.

[0154] When a delivery system is used to deliver a fluid composition, the fluid composition can be pre-loaded in a reservoir of the system or loaded into the reservoir prior to use of the system. An exemplary delivery system for delivering a fluid composition to Schlemm's canal is described in Fig.22A and Fig. 22B Reference Fig.22A , the delivery system 1000 includes a universal handle 1002 having a grip portion 1004 and a housing 1006. The housing 1006 has a proximal end 1008 and a distal end 1010. A cannula 1012 is coupled to the housing distal end 1010 and extends from the housing distal end. A drive assembly 1014 is substantially contained within the housing 1006, which actuates movement of a slidable conduit (not shown). The cannula 1012 and the drive assembly 1014 have similar Fig.15 and Figure 16A-16B The same configuration as the system customized for ocular device implantation shown and described in and therefore will not be described in detail here.

[0155] Delivery system 1000 also includes a fluid assembly 1016 ( Fig. 22B10), the fluid assembly has a loading component 1018 configured to allow a fluid composition to be transferred from an external source to a reservoir defined by the fluid assembly and a linear gear 1020. A slidable conduit 1022 is coaxially disposed within a cannula lumen in fluid communication with the reservoir. As previously described, in a tool-based system that does not deliver an implant or fluid, the system may not include a reservoir.

[0156] In an exemplary method, Figure 23A-23C As shown, the fluid composition can be delivered to the reservoir 1102 of the system 1100 via loading through the loading component 1104. As shown, the reservoir 1102 is defined by the fluid assembly 1106 and the linear gear 1108. The linear gear 1108 has a proximal end 1110 and a distal end 1112 and a lumen 1114 extending from the proximal end 1110 to the distal end 1112. The lumen 1114 is in fluid communication with the lumen (not shown) of the slidable tube 1118.

[0157] To deploy the fluid composition out of reservoir 1102, linear gear 1108 is retracted in the direction of the arrow ( Fig. 23B ), so that the reservoir 1102 is pressurized. Retraction can be achieved by rotation of the pinion mechanism 1120. Once a sufficient amount of pressure is generated in the reservoir 1102, the fluid composition contained therein is injected through the linear gear lumen 1114 and the tubing 1118 into Schlemm's canal.

[0158] The slidable conduits used in the systems described herein can have various configurations. Fig.24 As shown, the conduit 1200 can be a flexible cannula having a lumen in fluid communication with an opening at the distal end 1202. Here, any fluid being delivered flows through the distal end 1202 to Schlemm's canal. In other variations, the slidable conduit 1300 can be configured to include a plurality of openings spaced along its axial length. The openings can have any suitable shape, such as a slot 1302 ( Fig.25A ) or circle 1304( Fig.25B ).use Fig.25A and Fig.25B The fluid composition conveyed by the depicted conduit can flow out of the conduit partially through the opening and partially through the distal end of the conduit. The distal end of the conduit can also be configured as a half sleeve 1306 ( Fig.25C ).

[0159] Also provided is a method for implanting an ocular device using the above-mentioned system and for delivering a fluid composition to Schlemm's canal. Further described is a method without implants for providing a force (such as by providing a destructive volume or a destructive tool) that is enough to destroy trabecular tubule tissue. These methods are typically minimally invasive methods controlled by one hand, a single operator, and for example, these methods are customized for internal road surgery, and as previously mentioned, this may be superior to more invasive external road (ab-externo) methods. However, it may be considered to use an ocular system in external road methods in some cases, and therefore not excluded here. The method for delivering an ocular device or fluid or for providing destructive force can be used for treating glaucoma, early glaucoma or intraocular hypertension. When treating glaucoma, the method can also be used in combination with cataract surgery (before or after) using the same incision.

[0160] Generally speaking, methods for implanting an ocular device into Schlemm's canal first include the step of forming an incision in the wall of the eye (e.g., the sclera or cornea) that provides access to the anterior chamber of the eye. Fig.26 As shown in the stylized depiction of the eye in FIG. 1 , the cannula 1400 of the ocular delivery system is then advanced through the incision and at least partially through the anterior chamber 1402 to reach the trabecular meshwork (not shown). The distal curved portion 1406 of the cannula is then used to enter the Schlemm's canal (i.e., the lumen of the Schlemm's canal) 1404, and a slidable positioning element (or, for example, a slidable tool or guide wire) or a slidable conduit (generally represented by element 1408) is advanced from the cannula to implant the ocular device in the Schlemm's canal, perform surgery in the Schlemm's canal or on any adjacent trabecular canal tissue, or deliver the fluid to the canal. However, in some cases, a slidable conduit may not be used to deliver any fluid to be delivered through the cannula. In other variations, only the trabecular meshwork is punctured, and the fluid composition is delivered without bypassing the Schlemm's canal.

[0161] As previously described, the cannula can be configured to include a proximal end and a distal curved portion, wherein the distal curved portion has a proximal end, a distal end, and a radius of curvature defined between the ends. Here, the cannula can also include a body and a distal tip having a bevel that directly engages the radius of curvature, for example, the bevel is adjacent to the radius of curvature. The method can also include the steps of flushing the system with a fluid (e.g., to remove air from the system) and / or irrigating the surgical area to clear blood or otherwise improve visibility of the area.

[0162] Any suitable ocular device that maintains Schlemm's canal patency or improves aqueous humor outflow can be implanted by the system described herein. For example, an ocular device that maintains Schlemm's canal patency without substantially interfering with fluid flow through and along the canal can be implanted. Such a device can include a support member having at least one perforation. An ocular device that destroys the paratubular trabecular meshwork or the adjacent inner wall of Schlemm's canal can also be implanted. In addition to ocular devices made of metal or metal alloys, sutures, modified sutures, modified polymers or solid viscoelastic structures can also be delivered. Fluid compositions, such as saline, viscoelastic fluids, air and gas can also be delivered.

[0163] When the fluid composition is delivered to Schlemm's canal, the method generally includes the following steps: forming an incision in the eye wall (e.g., sclera or cornea) that provides access to the anterior chamber of the eye; advancing a cannula of an ocular delivery system through the incision and at least partially through the anterior chamber to the trabecular meshwork; using the cannula to enter Schlemm's canal; and using a slidable conduit in the cannula lumen to deliver the fluid composition to the tube. The cannula can be configured to include a proximal end and a distal curved portion, wherein the distal curved portion has a proximal end, a distal end, and a radius of curvature defined between the two ends. Here, the cannula can also include a body and a distal end having a bevel that directly engages the radius of curvature, for example, the bevel is adjacent to the radius of curvature. Further advantageous cannula features as described above may also be included. The method may also include a step of flushing the system with a fluid (e.g., removing air from the system) and / or a step of irrigating the surgical area to remove blood or otherwise improve visibility of the area.

[0164] When adopting the inner route method to implant an ocular device, the method may include the following steps. The surgeon may first use an operating microscope and a gonioscope or a gonioprism to observe the anterior chamber and the trabecular meshwork (and Schlemm's canal below). Using 0.5mm or larger cornea, limbus or sclera incision, the surgeon can then obtain access to the anterior chamber. Then saline solution or viscoelastic composition can be introduced into the anterior chamber to prevent the anterior chamber from collapsing. Here, saline solution or viscoelastic composition can be delivered by the delivery system cannula or delivered by another mode, such as by the sleeve infusion on the cannula. Then, the surgeon can advance the cannula of the delivery system through the incision towards the anterior chamber angle under direct microscope visualization. When approaching the angle (and therefore approaching the trabecular meshwork), the surgeon can apply a gonioscope or a gonioprism to the cornea to visualize the angle. Viscous fluid (e.g., viscoelastic composition as described above) is applied to the cornea and / or a gonioscope or a gonioprism can help to achieve good optical contact. When the surgeon visualizes the trabecular meshwork, the cannula can then be advanced so that the bevel at the distal end of the curved distal portion of the cannula pierces the meshwork and communicates with the lumen of Schlemm's canal. The surgeon can perfuse saline or viscoelastic composition into the cannula or the anterior chamber to prevent the cannula or the anterior chamber from collapsing, expanding Schlemm's canal, or washing away any blood that may hinder visualization of the cannula and the ocular device delivery. Next, when the ocular device is advanced to the extent desired by the surgeon, the ocular device is released from the engagement mechanism so that the ocular device can reside in Schlemm's canal. If the ocular device is needed or desired to be repositioned, the surgeon can retract and / or reposition the ocular device using the positioning element of the delivery system. The surgeon can then withdraw the delivery system from the eye.

[0165] Other variations of the internal route method for implanting an ocular device include the use of an endoscope. Similar to the above method, the anterior chamber is first entered by cutting the cornea, limbus or sclera. Similarly, this can be completed in a one-time combination with cataract surgery, or completed before or after cataract surgery, or completed independently. The anterior chamber can be infused with saline solution, or a viscoelastic composition can be placed in the anterior chamber to prevent the anterior chamber from collapsing. Saline or viscoelastic materials can be delivered as a separate step, or saline or viscoelastic materials can be infused with the pipeline of the delivery system, the sleeve on the pipeline, or with a separate infusion cannula. Then, the surgeon advances the endoscope through the incision and advances toward the anterior chamber angle and trabecular meshwork under direct microscope visualization. When the surgeon uses an endoscope or any associated video display to visualize the trabecular meshwork, the inclined surface of the cannula is advanced to pierce the reticular tissue. Then, the ocular device is advanced using a positioning element under endoscopic visualization. The surgeon can perfuse saline or viscoelastic composition into the tube or anterior chamber to prevent collapse of the anterior chamber, to enlarge Schlemm's canal, or to wash away any blood that may interfere with visualization of cannulation and ocular device delivery. When the ocular device is advanced to the extent desired by the surgeon, the ocular device is released from the engagement mechanism so that the ocular device can reside in Schlemm's canal. If repositioning of the ocular device is required or desired, the surgeon can retract and / or advance the ocular device using the positioning element of the delivery system. The surgeon can then withdraw the delivery system from the eye.

[0166] About the delivery of fluid composition, the method is similar to the implantation of ocular device. However, the delivery system is not to use positioning element but to adopt slidable pipeline to infuse fluid composition into Schlemm's canal. The surgeon can first use operating microscope and gonioscopic lens or gonioprism to observe the anterior chamber and trabecular meshwork (and Schlemm's canal below). Using 0.5mm or larger cornea, limbus or scleral incision, the surgeon can then obtain the access to the anterior chamber. Then saline solution or viscoelastic composition can be introduced into the anterior chamber to prevent the anterior chamber from collapsing. Here, saline solution or viscoelastic composition can be delivered by the delivery system cannula or delivered by another mode, such as by the sleeve infusion on the cannula. Then, the surgeon can advance the cannula of the delivery system through the incision towards the anterior chamber angle under direct microscope visualization. When approaching the angle (and therefore approaching the trabecular meshwork), the surgeon can apply gonioscopic lens or gonioprism to the cornea to visualize the angle. Applying a viscous fluid (e.g., a viscoelastic composition as described above) to the cornea and / or gonioscopic lens or gonioprism can help achieve good optical contact. When the surgeon visualizes the trabecular meshwork, the cannula can then be advanced so that the bevel at the distal end of the curved distal portion of the cannula pierces the reticular tissue and is communicated with the lumen of Schlemm's canal. Next, under gonioscopic visualization, the slidable conduit coaxially arranged in the cannula lumen can be advanced into the tube. The slidable conduit can be advanced around the tube with any suitable amount and direction. For example, the slidable conduit can be advanced around the tube between about 10 degrees to about 360 degrees, or the slidable conduit can be advanced in two steps, for example, advancing 180 degrees in a clockwise direction around the tube and advancing 180 degrees in a counterclockwise direction (thus achieving complete 360 ​​degrees of internal road visco-tube ostomy or tube plasty). Fluid can be injected when the pipeline is advanced or retracted. Once the slidable conduit is positioned in the tube, the fluid composition (e.g., viscoelastic solution) can be continuously or intermittently transported through the pipeline. The fluid composition can leave the conduit through the distal end of the conduit (e.g., through the distal tip), or through openings or perforations disposed along its axis, or a combination of the two. The openings or perforations can be spaced along the axial length of the conduit in any suitable manner, such as symmetrically or asymmetrically spaced along the length of the conduit. If desired, other substances (e.g., drugs, air, or gases) can be transported in the same manner.

[0167] The slidable conduit can be repositioned by retraction or repeated advancement and retraction. In some variations of the method, the same or different incisions can be used, but the delivery system cannula can be used to enter and enlarge Schlemm's canal from a different direction (e.g., counterclockwise instead of clockwise). Once a sufficient amount of fluid has been delivered, the surgeon can retract the slidable conduit into the cannula and remove the delivery system from the eye. It should be understood that these steps can be used alone or in combination with cataract surgery (completed at one time).

[0168] Other variations of the internal route method for conveying fluid compositions include the use of an endoscope. Similar to the method directly described above, the anterior chamber is first entered by cutting the cornea, limbus or sclera. Similarly, this can be completed in a one-time combination with cataract surgery, or completed before or after cataract surgery, or completed independently. The anterior chamber can be infused with saline solution, or the viscoelastic composition can be placed in the anterior chamber to prevent the anterior chamber from collapsing. Saline or viscoelastic materials can be delivered as separate steps, or saline or viscoelastic materials can be infused with the pipeline of the conveying system, the sleeve on the pipeline, or with a separate infusion cannula. Then, the surgeon advances the endoscope through the incision and advances toward the anterior chamber angle and trabecular meshwork under direct microscope visualization. When the surgeon visualizes the trabecular meshwork via an endoscope or any associated display, the inclined surface of the cannula is advanced to pierce the reticular tissue. Then, the slidable conduit is advanced under endoscopic visualization. The slidable conduit can be advanced around the tube with any suitable amount and direction. For example, slidable pipeline can be advanced around pipe between about 10 degree to about 360 degree, or can advance slidable pipeline in two steps, for example, advance 180 degree in clockwise direction and advance 180 degree in counterclockwise direction (realizing complete 360 ​​degree internal road visco-tube ostomy thus) around pipe. Once slidable pipeline is positioned in pipe, fluid composition (for example viscoelastic fluid) can be continuously or intermittently transported through pipeline. Fluid composition can leave pipeline by the distal end of pipeline (for example, by distal end) or by opening or perforation or both combinations arranged along its axis. Opening or perforation can be separated along the axial length of pipeline in any suitable manner, for example symmetrically or asymmetrically separated along its length. If desired, other materials (such as medicine, air or gas) can be transported in the same manner.

[0169] The slidable conduit can be repositioned by retraction or repeated advancement and retraction. In some variations of the method, the same or different incision can be used, but the delivery system cannula can be used to enter and enlarge Schlemm's canal from a different direction (e.g., counterclockwise instead of clockwise). Once a sufficient amount of fluid has been delivered, the surgeon can retract the slidable conduit into the cannula and remove the delivery system from the eye.

[0170] The external method of implanting an ocular device or conveying a fluid composition may include additional or slightly different steps. For example, the formation of a tissue flap, suturing, etc. may be part of the external method. In general, the external method for implanting an ocular device may include the following steps. First, under microscopic visualization, the conjunctiva is incised, a scleral flap is formed, and the tissue is dissected to determine the mouth of Schlemm's canal. The anterior chamber can be infused with saline alone, or the viscoelastic composition can be placed in the anterior chamber to prevent the collapse of the anterior chamber angle. This operation can be completed as an independent procedure or in combination with cataract surgery. This operation can also be completed before or after the cataract surgery portion.

[0171] Using the delivery system described herein, the cannula can be advanced into Schlemm's canal and the ocular device can be advanced using a positioning element through a gonioscopic lens or gonioprism or under direct microscope visualization. When the ocular device is advanced to a desired amount, the surgeon can release the ocular device from the positioning element by actuating an engagement mechanism and remove the delivery system from the eye and surgical area. The scleral wound is then closed using, for example, sutures or tissue adhesives. If the ocular device is needed or desired to be repositioned, the surgeon can retract and / or advance the ocular device using the positioning element of the delivery system.

[0172] About the delivery of fluid composition, the external method is similar to the internal delivery. However, the delivery system does not use a positioning element but adopts a slidable pipeline to infuse the fluid composition into Schlemm's canal. First, under microscope visualization, the conjunctiva is cut, a scleral flap is formed, and the tissue is dissected to determine the mouth entering Schlemm's canal. The anterior chamber can be infused with saline alone, or the viscoelastic composition can be placed in the anterior chamber to prevent the collapse of the anterior chamber angle. This operation can be completed as an independent procedure or completed in combination with cataract surgery. This operation can also be completed before or after the cataract surgery part.

[0173] Using the delivery system described herein, the cannula can be advanced into Schlemm's canal, and the slidable pipeline coaxially arranged in the cannula lumen can be advanced into the tube under gonioscopic visualization. Once the slidable pipeline is positioned in the tube, a fluid composition (e.g., a viscoelastic fluid) can be continuously or intermittently delivered through the pipeline. The fluid composition can leave the pipeline by the distal end of the pipeline (e.g., by the distal end), or by the opening or perforation arranged along its axis, or a combination of the two. The opening or perforation can be separated along the axial length of the pipeline in any suitable manner, for example, symmetrically or asymmetrically separated along its length. If desired, other materials (such as medicine, air or gas) can be delivered in the same manner. The slidable pipeline can be repositioned by retracting or repeatedly advancing and retracting. The delivery system can then be removed from the eye.

[0174] The fluid composition may be delivered in a manner wherein retraction of the system components allows the fluid to be advanced out of the system cannula. Figure 23A-23C , the linear gear 1108 retracts in the direction of the arrow ( Fig. 23B ), so that the reservoir 1102 is pressurized. Retraction can be achieved by rotation of the pinion mechanism 1120. Once a sufficient amount of pressure is generated in the reservoir 1102, the fluid composition contained therein is injected through the linear gear lumen 1114 and the pipeline 1118 into Schlemm's canal. It should be understood that the eye delivery system can be configured so that the fluid composition is continuously, passively, automatically or actively delivered by the surgeon. The fluid composition can also be delivered to the tube with a pump or auxiliary plunger independently of the gear shaft movement.

[0175] The fluid composition that can be delivered by the ocular system described herein includes saline and viscoelastic fluid. The viscoelastic fluid can include hyaluronic acid, chondroitin sulfate, cellulose, its derivatives or mixtures, or solutions thereof. In one variation, the viscoelastic fluid includes sodium hyaluronate. In another variation, the viscoelastic composition can further include a drug. For example, the viscoelastic composition can include a drug suitable for treating glaucoma, alleviating or reducing intraocular pressure, alleviating inflammation or scarring, and / or preventing infection. The viscoelastic composition can also include an agent that helps to visualize the viscoelastic composition. For example, a dye can be included, such as but not limited to fluorescein, trypan blue or indocyanine green. In some variations, a fluorescent compound or a bioluminescent compound is included in the viscoelastic composition to help visualize the viscoelastic composition. In other variations, the system only delivers drugs, but not viscoelastic compositions. In this case, the drug can be loaded onto or into a biodegradable polymer for sustained release, which elutes the drug over a period of weeks, months, or years. It is also conceivable that air or gas can be delivered with the system.

[0176] Fluid compositions can be delivered to expand Schlemm's canal. The entire length of Schlemm's canal or a portion thereof can be expanded by the fluid. For example, at least 75%, at least 50%, at least 25%, or at least 10% of the canal can be expanded. Fluid compositions can also be delivered to treat various medical conditions, including but not limited to glaucoma, pre-glaucoma, and high intraocular pressure.

[0177] In addition, fluid compositions can be delivered to restore the tubular anatomical structure of Schlemm's canal, clear the obstruction in the canal, destroy the inner wall of Schlemm's canal or the trabecular meshwork beside the canal in the canal, or dilate the canal. Here, the delivery system can include wires, sleeves, balloons, instruments for delivering energy to the tissue, and / or other features that contribute to these methods. It is envisioned that such systems with additional features can be used to treat glaucoma. The surfaces of these systems can also be rough or have projections to further destroy the inner wall of Schlemm's canal and the trabecular meshwork beside the canal to enhance aqueous humor outflow or permeability.

[0178] When the system and device are customized to provide destructive force to the trabecular canalicular tissue, an implant-free method can be used, such as by delivering a destructive volume of viscoelastic fluid, advancing a destructive tool (such as a cannula, a pipeline, a catheter, etc.) (including one or more destructive components on its distal portion), or both. Exemplary destructive components include but are not limited to notches, hooks, barbs, or combinations thereof. Depending on factors such as the type or severity of the condition being treated, destructive force can be generated to partially or completely damage and / or remove the trabecular meshwork, and the destructive force can be adjusted by changing the volume of the delivered viscoelastic fluid or by changing the tool configuration. The exemplary volume of the viscoelastic fluid that can be sufficient to provide destructive force can range from about 1 μl to about 50 μl, from about 1 μl to about 30 μl, or from about 2 μl to about 16 μl. In a variation, a volume of about 4 μl is sufficient to destroy Schlemm's canal and / or surrounding tissue. In other variations, the volume of viscoelastic fluid sufficient to disrupt trabecular tubular tissue may be about 2 μl, about 3 μl, about 4 μl, about 5 μl, about 6 μl, about 7 μl, about 8 μl, about 9 μl, about 10 μl, about 11 μl, about 12 μl, 13 μl, about 14 μl, about 15 μl, about 16 μl, about 17 μl, about 18 μl, about 19 μl, about 20 μl, about 25 μl, about 30 μl, about 35 μl, about 40 μl, about 45 μl, or about 50 μl. The volume of viscoelastic fluid sufficient to disrupt trabecular tubular tissue may be about 2 μl, about 3 μl, about 4 μl, about 5 μl, about 6 μl, about 7 μl, about 8 μl, about 9 μl, about 10 μl, about 11 μl, about 12 μl, 13 μl, about 14 μl, about 15 μl, about 16 μl, about 17 μl, about 18 μl, about 19 μl, about 20 μl, about 25 μl, about 30 μl, about 35 μl, about 40 μl, about 45 μl, or about 50 μl. Fig.28 The total volume of viscoelastic fluid delivered along a 360 degree arc 1600 of Schlemm's canal during advancement or withdrawal of the canal (as shown), or the total volume of viscoelastic fluid delivered along an arc of smaller degrees during multiple advancements or withdrawals of the canal.

[0179] For example, Fig.29 As shown, the conduit 1700 can be advanced along a 180 degree arc of the tube in both a clockwise direction 1702 and a counterclockwise direction 1704 to deliver fluid from, for example, a single access point 1706 in the tube. Fig.28 and Fig.29, an exemplary destructive volume of 4 μl can be delivered along a 360-degree arc of the tube while advancing the tube from a single access point in the tube, or an exemplary destructive volume of 2 μl can be delivered along a 180-degree arc of the tube while advancing the tube from a single access point in the tube twice (one advancement in a clockwise direction and the other advancement in a counterclockwise direction). The tube can enter the tube from a single point or from multiple points. The amount or degree of tissue destruction can vary depending on the volume of fluid delivered. For example, 8 μl can be used to penetrate or gently tear the meshwork, while 16 μl can be used to tear the meshwork to the greatest extent. More specifically, about 1 μl to 2 μl can be used to enlarge Schlemm's canal and collector channels; about 2 μl to 4 μl can be used to enlarge Schlemm's canal and collector channels, and destroy / stretch the paratubular tissue; about 4 μl to 6 μl can be used for all of the foregoing as well as to form microtears in the trabecular meshwork and paratubular tissue (further increasing porosity and outflow). Volumes of about 8 μl to 16 μl can be used for all of the foregoing as well as substantially penetrating / tearing the trabecular meshwork and paratubular tissue. Volumes of about 16 μl to 50 μl can be used to substantially or completely tear the trabecular meshwork. When no fluid is used and only a destructive tool is employed, the outer diameter of the tubing or tool can be of different sizes to disrupt tissue, similar to how the fluid volume is varied to vary the level of disruption.

[0180] For example, a pipe 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 diaphragm that hinders the flow of the circumferential tubule. A pipe or tool with an outer diameter ranging from about 100 microns to 200 microns can be used to perform the aforementioned operation, and it is also possible to begin to stretch the trabecular meshwork and the paratubular tissue. A pipe or tool with an outer diameter ranging from about 200 microns to about 300 microns may be able to perform the above operation, but it is also possible to form micro-tears in the trabecular meshwork and the paratubular tissue, and it is possible to expand the collector channel to the greatest extent. A pipe or tool with an outer diameter ranging from about 300 microns to about 500 microns may destroy the tissue to the greatest extent, and may form tears or perforations along the trabecular meshwork and the paratubular tissue. In addition, the farther the pipe or tool is advanced in the tube, the better the effect of the operation. For example, the tube or tool can be pushed out of the end of the cannula and advanced into the tube at approximately a 30 degree arc of the tube (e.g., advanced approximately 3 mm to 4 mm outside the cannula), advanced into the tube at approximately a 60 degree arc of the tube (e.g., advanced approximately 6 mm to 8 mm outside the cannula), advanced into the tube at approximately a 90 degree arc of the tube (e.g., advanced approximately 10 mm outside the cannula), advanced into the tube at approximately a 120 degree arc of the tube (e.g., advanced approximately 15 mm outside the cannula), advanced into the tube at approximately a 180 degree arc of the tube (e.g., advanced approximately 20 mm outside the cannula), or advanced into approximately a full 360 degree arc of the tube (e.g., advanced approximately 36 mm to 40 mm outside the cannula) to achieve maximum efficacy and minimize intraocular pressure reduction.

[0181] The implant-free method for treating eye disorders can include advancing pipeline into Schlemm's canal, wherein the pipeline has been loaded with a certain volume of viscoelastic fluid, and the method includes transporting the viscoelastic fluid into Schlemm's canal, and the volume of the viscoelastic fluid transported is enough to destroy trabecular tubule tissue, to reduce intraocular pressure. However, the implant-free method for treating eye disorders does not necessarily include transporting viscoelastic fluid. In these cases, the method can include advancing device into Schlemm's canal, wherein the diameter of the device is between about 300 microns and about 500 microns or between about 150 microns and about 200 microns, and wherein the device is advanced into Schlemm's canal to destroy the tube and / or trabecular tubule tissue in a manner that is enough to reduce intraocular pressure.

[0182] Other methods for treating eye conditions can be a one-handed, single operator method for introducing a viscoelastic fluid into Schlemm's canal, the method comprising advancing a tube into Schlemm's canal, wherein the tube is already loaded with a volume of viscoelastic fluid, and the method comprises delivering the viscoelastic fluid into Schlemm's canal, wherein delivering the volume of viscoelastic fluid is accomplished by a single-handed device used by a single operator.

[0183] Similarly, when viscoelastic fluid is delivered with the method disclosed herein, the destructive volume can be between about 2 μ l and about 8 μ l. It may be beneficial to deliver viscoelastic fluid of about 4 μ l volume in some cases. While the pipeline of the device controlled by a single hand, a single operator is advanced along clockwise, counterclockwise or both directions from Schlemm's canal, or in the process of withdrawing the pipeline from Schlemm's canal, viscoelastic fluid can be delivered. As previously mentioned, viscoelastic fluid can be delivered to destroy Schlemm's canal and surrounding trabecular tubule tissue. For example, the viscoelastic fluid delivered can cause destruction by expanding Schlemm's canal, increasing the porosity of the trabecular meshwork, stretching the trabecular meshwork, forming a tiny tear in the paratubular tissue, removing the diaphragm from Schlemm's canal, expanding the collector channel or its combination. The pipeline can be loaded with viscoelastic fluid at the beginning of eye surgery so that the fluid can be delivered by a single device. This is in contrast to other systems that use forceps or other advancement tools to advance the fluid delivery catheter into Schlemm's canal and / or devices containing viscoelastic fluids that are separate or independent from the delivery catheter or catheter advancement tool and which need to be connected to the delivery catheter or catheter advancement tool by an assistant during surgery while the delivery catheter or catheter advancement tool is held by the surgeon.

[0184] In some variations, the methods disclosed herein may include advancing the pipeline (or tool) into 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 another variation, the pipeline (or tool) may be advanced into an arc of about 0 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 access point in Schlemm's canal or from multiple access points in the tube. When a destructive force is to be provided, it may be beneficial to advance the pipeline from a single access point in Schlemm's canal in a clockwise and counterclockwise direction into an arc of about 180 degrees of Schlemm's canal.

[0185] Before the introduction of goniotomy and trabeculotomy (these two operations are usually used to treat the blocked trabecular meshwork, usually caused by genetic factors in childhood), congenital glaucoma usually leads to blindness. Although goniotomy (which is performed in the inner route, but using a sharp scalpel to cut the mesh of 30 degrees-60 degrees to improve outflow) and trabeculotomy (external route method, in which a deep scleral incision opens the top of Schlemm's canal and cuts the mesh with a probe) are invasive, these operations are considered to be effective and have prevented many pediatric patients from lifelong blindness. In 1960, Burian and Smith independently described external trabeculotomy. In this highly invasive endoscopic procedure, the surgeon makes a deep scleral incision, locates Schlemm's canal, cannulate a full 360 degrees of Schlemm's canal from the outside with a catheter or specially designed probe (called a trabeculotome), and finally tightens the ends of the catheter or probe so that the trabeculotome cuts through the entire trabecular meshwork into the anterior chamber to improve drainage.

[0186] An attempt to reduce the invasiveness of extrinsic trabeculotomy was recently developed by NeoMedix, which commercialized a device called the "Trabectome." The Trabectome attempts to make trabeculotomy easier by using an endo-approach. The device and method involve removing the trabecular meshwork from the endo-approach by electrocautery using an instrument that also provides infusion and aspiration. The disadvantages of the Trabectome are threefold: 1) the device uses an energy-based mechanism to ablate the trabecular meshwork, which is thought to cause inflammation and scarring in the eye, which in turn may adversely affect outflow and pressure; 2) the device / procedure is ergonomically limited - in addition to being limited to 60-120 degrees of tissue treatment per corneal or scleral entry incision, it requires a foot pedal and power cord to activate electrocautery and irrigation; and 3) because it involves energy-based ablation and irrigation, there is a significant capital equipment cost, which may limit use.

[0187] The methods (and systems and devices) described herein, including methods for providing disruptive forces to trabecular canalicular tissue, may be highly suitable for internal trabeculotomy and goniotomy because they avoid the use of electrocautery and are capable of advancing a tube over a greater degree of arc of Schlemm's canal. In some variations of internal trabeculotomy and goniotomy methods, the procedure includes advancing a cannula at least partially through the anterior chamber of the eye, using the cannula to enter Schlemm's canal at a single access point, and delivering a volume of viscoelastic fluid through a tube slidable within and extendable from the cannula, the volume of viscoelastic fluid delivered being sufficient to disrupt the structure of Schlemm's canal and surrounding tissue to reduce intraocular pressure. Other methods that can be used to treat eye conditions include the following steps: using a pipeline that can extend from a handle that can be controlled by a single operator to enter Schlemm's canal, the handle includes a fluid reservoir; and by increasing the pressure in the fluid reservoir, a certain volume of viscoelastic fluid is transported from the fluid reservoir through the pipeline, wherein the volume of the viscoelastic fluid transported is sufficient to destroy the structure of Schlemm's canal and surrounding tissues to reduce intraocular pressure. The destructive volume can be between about 2 μl and about 16 μl. In a variation, the destructive volume is about 4 μl of viscoelastic fluid. As previously mentioned, in some cases, the destructive volume can be in any range between about 20uL and about 50uL.

[0188] More specifically, disruption (e.g., cutting, disrupting, removing, etc.) of the trabecular meshwork may be achieved by removing the cannula from the eye while leaving the tubing in the tube, thereby tearing the meshwork. Alternatively, tissue disruption may occur due to excessive and intentional viscous expansion of the tube with at least about 1 μl, at least about 2 μl, at least about 3 μl, at least about 4 μl, at least about 5 μl, at least about 6 μl, at least about 7 μl, at least about 8 μl, at least about 9 μl, at least about 10 μl, at least about 11 μl, at least about 12 μl, at least about 13 μl, at least about 14 μl, at least about 15 μl, at least about 16 μl, at least about 17 μl, at least about 18 μl, at least about 19, or at least about 20 μl of viscoelastic fluid per 360 degree arc of the tube. The amount or degree of tissue disruption may vary depending on the volume of fluid delivered. For example, 8 μl can be used to penetrate or gently tear the mesh tissue, while 16 μl can be used to tear the mesh tissue to the greatest extent. In some variations, at least about 20 μl, at least about 25 μl, at least about 30 μl, at least about 35 μl, at least about 40 μl, at least about 45 μl, or at least about 50 μl of viscoelastic fluid can be delivered.

[0189] Another method for disrupting tissue can include using an oversized tube (e.g., having an outer diameter of 300-500 microns) to tear the meshwork during delivery, or inflating or expanding the tube once it has been fully advanced into Schlemm's canal to stretch, damage, destroy, or completely tear the meshwork. For example, a catheter / tube, stylet, or wire (with or without a lumen) with a distal outer diameter of 200-250 microns can be used, but its shaft begins to flare outward after 3 hours in Schlemm's canal (i.e., at a mark of about 5 or 10 mm on the catheter / tube) to about 300 microns, to about 400 microns, or to about 500 microns, so that when the distal end is comfortably advanced in Schlemm's canal, the enlarged shaft trails behind the trabecular meshwork and ruptures the trabecular meshwork as the enlarged shaft is advanced.

[0190] In other methods, tissue disruption can be achieved by endo-delivery of a suture throughout Schlemm's canal, which is then tensioned sufficiently to stretch the canal, disrupt the trabecular meshwork, and / or tear the meshwork ("endo-suture trabeculotomy"). Here, a tool including a grasping element can be used to pull the distal suture end inwardly as the cannula is withdrawn from the eye, severing all 360 degrees or a portion of the trabecular meshwork, or to tie the suture ends together to provide tension on the meshwork without necessarily tearing the meshwork.

[0191] Can also utilize the main body section that is positioned at the proximal end of pipeline to be customized to have one or more notches or barbs, these one or more notches or barbs grasp reticular tissue when being guided and advanced along Schlemm's canal at the distal end, thus destroy, partially tear, tear completely and / or remove trabecular meshwork when advancing.In addition, can use implant with edge, this edge is specially designed to cut reticular tissue.Other methods for destroying tissue can comprise customization system (for example, pipeline, any conduit or wire, probe end etc.) to grasp or hold reticular tissue when retracting after advancing through pipe completely. This can be accomplished using a wire with a curved tip, hook, notch, or barb at its end that is advanced through the lumen of the catheter, which then hooks the mesh upon retraction, tearing the mesh along its length or removing the mesh entirely, or using just a metal or polymer wire or suture (without a catheter) that has a hooked, notched, or barbed tip in such a way that it can be advanced into Schlemm's canal without tearing the mesh, but hooks the mesh upon retraction, tearing the mesh and / or removing the mesh entirely. Fig. 30A, cannula 1800 can be inserted into the anterior chamber 1802 and Schlemm's canal 1804, and a tool (e.g., slidable tubing 1806) can be advanced within tube 1804. Fig. 30B As shown, the cannula 1800 can be withdrawn from the anterior chamber 1802 without retracting the slidable conduit 1806. This action itself may tear the trabecular meshwork. Fig. 30C As shown, the tube 1806 can be provided with a destructive tool, such as a sharp-edged element 1808, which can cut or tear the trabecular meshwork while being retracted into the stationary cannula 1800. Exemplary sharp-edged elements can be hooks, wires, or any other suitable shape memory component that can extend from the cannula to tear, cut, or remove the trabecular meshwork.

[0192] The configuration of the ocular delivery system may be advantageous in many different aspects. In one aspect, the delivery system can be used for an intra-path method of implanting an ocular device in Schlemm's canal or an intra-path method of delivering a fluid composition or tool to the canal. On the other hand, the delivery system cannula is configured to allow easy and atraumatic access to Schlemm's canal. In addition, the delivery system is configured in a manner to give the surgeon greater freedom of use, all in a single instrument. For example, the handle of the system is configured so that the handle can be used with the right hand or left hand on the right eye or left eye, as long as the handle is flipped or the cannula is rotated. In addition, the delivery system is designed so that it can be used with the right hand to enter Schlemm's canal in a counterclockwise manner, with the left hand to enter Schlemm's canal in a clockwise manner, or with the left hand to enter Schlemm's canal in a counterclockwise manner, etc. Therefore, access to Schlemm's canal from all four quadrants of the eye can be achieved. In yet another aspect, the delivery system comprises a one-handed, single operator controlled device configured to provide sufficient force to disrupt Schlemm's canal and surrounding tissue to improve flow through the trabecular canal outflow path. The system typically combines an access cannula, a delivery conduit, a conduit advancement mechanism, a disruptive tool, and a viscoelastic fluid into a single device so that one person or hand can advance the conduit or tool, or deliver the fluid.

[0193] Fig.31A and Fig.31B Schematically illustrated are top views of an embodiment of a cannula adapter 2100 in an undeployed configuration and a deployed configuration, respectively. Cannula adapter 2100 includes a connector 2105, a housing 2110, an inner catheter 2115, and an outer cannula 2120.

[0194] The connector 2105 (e.g., a standard Luer connector) can be adapted to slide within the housing 2110 of the cannula adapter 2100 along a limited axial range. The connector 2105 may also be limited in azimuthal rotation. The inner catheter 2115 may include a flexible lumen that is introduced through Schlemm's canal and that is fluidly coupled to the distal end of the sliding connector 2105. The lumen of the inner catheter 2115 may extend from the proximal end to the distal end of the inner catheter 2115. The inner catheter 2115 may be adapted to fit within and extend through the lumen of the outer cannula 2120 so that when the sliding connector 2105 is in the most proximal position, such as in Fig.31A In the undeployed configuration shown, the distal tip of the inner catheter 2115 and the distal end of the outer cannula 2120 are aligned.

[0195] The proximal end of the outer cannula 2120 can be coupled to the distal end portion of the housing 2110 (and to the distal end of the sliding channel 2122 of the housing within which the connector 2105 translates axially). Fig.31B In the fully deployed configuration shown, when the connector 2105 has been pressed forward until the sliding channel 2122 in the housing 2110 terminates), the distal end of the inner catheter 2115 can extend beyond the distal end of the outer cannula 2120 to a predetermined distance. In some embodiments, the predetermined distance can be approximately equal to the circumference of Schlemm's canal (e.g., 360 degrees). When the connector 2105 is in the farthest position in the sliding channel 2122 of the housing 2110, the length of the portion of the inner catheter 2115 extending beyond the distal end of the outer cannula 2120 can be configured to have a length corresponding to a value in the upper range of the circumference of Schlemm's canal of a human or other mammal (e.g., the maximum known value) or a length corresponding to an average or intermediate value.

[0196] The distal portion of the inner catheter 2115 (e.g., at least the portion extending beyond and including the distal tip) can be pre-formed (e.g., using a shape memory material such as a copper-aluminum-nickel alloy or a nickel-titanium alloy to set the shape) to approximately follow the radius of curvature of Schlemm's canal (e.g., a predetermined median or average value), or can be made of a material that is flexible enough to bend along the outer wall of Schlemm's canal (e.g., polyvinyl chloride, polyetheretherketone, polyethylene, polytetrafluoroethylene, thermoplastic polyurethane, polyamide, polyimide, polymethyl methacrylate (PMMA), acrylonitrile butadiene styrene, silicone and / or other sufficiently flexible materials).

[0197] Fig.31A and Fig.31BThe cannula adapter 2100 may be adapted to be used with any standard "off-the-shelf" or commercially available ophthalmic viscosurgical device (OVD) or other viscoelastic delivery device (such as the commercially available OVD made by Johnson & Johnson). Viscoelastic Syringe. For example, a pre-filled ophthalmic viscoelastic device (e.g., syringe) 2125 can be inserted into the proximal end of the housing 2110 and rotated to rigidly lock with the sliding connector 2105, such as Fig.31C As an example of use, an operator (e.g., a clinician or medical practitioner) can hold the housing 2110 with one hand and use the other hand to translate the syringe 2125 forward (e.g., distally or toward the patient) relative to the housing 2110 (e.g., by depressing the proximal stop 2127 of the syringe 2125) to extend the inner catheter 2115 (e.g., via translation of the sliding connector 2105) out of the outer cannula 2120, and then insert the syringe 2125 (e.g., by depressing the proximal plunger actuator 2128 of the syringe 2125, as shown in FIG. Fig.31D ), to deliver a desired amount of fluid 2126 (e.g., viscoelastic or other ophthalmic viscoelastic surgical device (OVD) fluid). The desired amount may be patient-specific or location-specific and may be determined by the operator as desired and / or required.

[0198] The outer cannula 2120 can be adapted for insertion through a minimally invasive, temporal, clear corneal incision. The corneal incision can be sized to self-seal without the need for sutures. Fig.31E An example method of surgical insertion using a superior insertion approach is shown. As shown, the distal portion 2121 of the outer cannula 2120 can be shaped (e.g., a spoon with a sharp tip) to facilitate penetration of the superior trabecular meshwork (TM) portion and guide the inner catheter 2115 360 degrees into Schlemm's canal (SC), as shown in FIG. Fig.31F Alternatively, a transnasal insertion method can be used to insert the distal end of the outer cannula 2120 through the nasal trabecular mesh, such as Figure 31G and Fig.31H shown.

[0199] In some embodiments, such as when using a transnasal insertion method, the inner catheter 2115 can be adapted to be advanced through the first 180 degrees of Schlemm's canal and then advanced through the remaining 180 degrees of Schlemm's canal. For example, the distal portion 2121 of the outer cannula 2120 can be inserted into the Schlemm's canal through the trabecular meshwork so that the inner catheter 2115 can be advanced through the first 180 degrees of the Schlemm's canal from the insertion position into the Schlemm's canal. Then, the inner catheter 2115 can be retracted, and the distal tip 2121 of the outer cannula 2120 can be rotated, or removed from the Schlemm's canal and reinserted so that the inner catheter 2115 can traverse the remaining 180 degrees of the Schlemm's canal from the entry point in the opposite direction. The distal tip 2121 of the outer cannula 2120 can be pre-bent, or can be sufficiently flexible to bend when in contact with the outer wall of the Schlemm's canal. If pre-curved, the distal tip of the outer cannula 2120 may have a different curvature or curved configuration depending on whether it is intended for a superior or transnasal insertion approach. In some embodiments, only a single 180 degree portion is treated.

[0200] Go to Fig.31I According to several embodiments, a fluid control adapter 2130 can be attached to the proximal end of a syringe 2125 to facilitate the precise controlled delivery of viscoelastics or other fluids (e.g., drugs, chemicals, solutions, other liquids). In such embodiments, the plunger handle of the syringe 2125 can be removed. In the illustrated embodiment, the fluid control adapter 2130 includes a dispenser connection fitting 2132, which is adapted to be attached to the syringe 2125 like a conventional pneumatic adhesive dispenser (such as a commercially available pneumatic dispenser made by Nordson EFD). The attachment fitting 2132 can have a threaded through hole for receiving a complementary threaded "bolt-type" plunger driver 2133 and a rotatable knob 2134. Clockwise rotation of the knob 2134 (and thereby rotation of the plunger driver 2133) can push the internal plunger of the syringe 2125, thereby dispensing the fluid 2126 (e.g., a viscoelastic or other OVD fluid). The sensitivity of the dispensing can be controlled by the pitch of the thread. Fluid control adapter 2130 can be rigidly connected to syringe 2125, and thus axial translation of adapter 2130 (e.g., caused by axial translation of knob 2134 resulting from rotation of knob 2134) can result in extension of inner catheter 2115. Rotatable knob 2134 can optionally include a knurled head.

[0201] refer to Fig.32A and Fig.32B, the cannula adapter 2200 can be improved or modified to include a sliding trigger 2202 that is rigidly attached to the inner sliding connector 2105 (e.g., as a single molded part during manufacturing) and that is allowed to slide axially relative to the housing 2110. The operator can then simply extend the inner catheter 2115 via distal movement (i.e., movement toward the patient) of his or her finger or thumb, rather than via depressing a proximal stopper of the syringe 2125 (e.g., depressing a proximal plunger actuator 2128 of the syringe 2125, as shown in FIG. 2 ). Fig.31D The outer surface of the sliding trigger 2202 may have surface features (eg, ridges, grooves, etc.) suitable for facilitating gripping or friction against an operator's fingers or thumb.

[0202] Fig.32C Shows the Fig.32A and Fig.32B A further modification or improvement of the cannula adapter 2200 is adapted to allow a single hand of the operator to actuate the inner catheter 2115 and dispense the viscoelastic substance or other fluid. The illustrated embodiment may include Figure 2 A and Figure 2 The sliding trigger 2202 introduced in B extends the inner catheter 2115 and incorporates a pneumatic system 2210 suitable for pressurizing the viscoelastic syringe 2125. Fig.32D and Fig.32E , pneumatic system 2210 is enlarged and its components and operation are shown in greater detail.

[0203] The pneumatic system 2210 may utilize a trigger 2212 that is adapted to be actuated by a finger (eg, index finger) of an operator. Fig.32D The pneumatic system 2210 is shown before the trigger 2212 is depressed, and Fig.32EThe pneumatic system 2210 is shown after the trigger is depressed (e.g., pushed in a direction away from the patient to compress the spring 2218). When the trigger 2212 is depressed (e.g., moved to its actuated position), a microvalve release pressurization cylinder 2216 (e.g., a commercially available pico cylinder made of Picocyl) can open to pressurize a chamber 2214, which is fluidly coupled to the proximal side of the syringe plunger (e.g., using an attachment similar to a conventional pneumatic adhesive dispenser). This arrangement or mechanism can advantageously allow for stable, controlled dispensing of a pressurized supply of fluid 2126 (e.g., a viscoelastic or other OVD fluid) from a syringe 2125. When the trigger 2212 is released, the spring 2218 can relax to an uncompressed configuration and push the pressure cylinder 2216 back to its nominal position, and the chamber 2214 is vented via the cut 2220 to, for example, abruptly stop the dispensing of the viscoelastic or other fluid. Fig.32E As shown, when the trigger 2212 is depressed, the valve 2222 of the pressure cylinder 2216 can open and the spring 2218 can be compressed, and when the trigger 2212 is released, the valve 2222 can be closed and the spring 2218 can be relaxed or extended (e.g., moved back to its unactuated position).

[0204] The trigger 2212 may include a notch 2220 formed on one side of the trigger body. Before the trigger 2212 is depressed, the notch 2220 may not be fluidly connected to the chamber 2214. When the trigger 2212 is depressed, the notch 2220 may form a path between the chamber 2214 and the atmosphere. When the trigger 2212 is fully compressed and the barrel 2216 is opened to pressurize the chamber 2214, the notch 2220 may be isolated from the atmosphere so that the pressure in the chamber 2214 can be maintained. When the trigger 2212 is released and moves back to its unactuated position, the notch 2220 may form a path between the chamber 2214 and the atmosphere to vent the chamber 2214, for example, as described herein, to suddenly stop the dispensing of viscoelastic substances or other fluids.

[0205] Figure 33A-Figure 33D An alternative embodiment of a viscoelastic dispensing mechanism incorporating a valve and a spring is shown, which may be incorporated into any of the embodiments described herein. Fig.33A A cannula adapter 2300 is shown that utilizes a compression spring 2304 to maintain force on a viscoelastic barrel / plunger 2306. As described herein, actuating the sliding trigger 2202 (e.g., sliding the sliding trigger toward the patient) can cause the catheter 2115 to extend out of the distal end of the outer cannula 2120. Fig.33AIn the example shown, the connector 2105 may include a dispensing button 2302 and a valve 2308. The dispensing button 2302 may have an unactuated position and an actuated position. Fig.33C 23), the body of the dispense button 2302 can interrupt the flow path within the connector 2105 and, for example, prevent the fluid 2126 from flowing from the viscoelastic cylinder 2306 into the conduit 2115. When in the actuated position (e.g., pressing down to compress the spring 2310, as shown in FIG. Fig.33D ), the lumen 2320 formed in the dispensing button 2302 can be connected to the flow path in the connector 2105 and between the viscoelastic tube 2306 and the catheter 2115. When the dispensing button 2302 is released, the spring 2310 can push the dispensing button 2302 back to the unactuated position and interrupt the flow path between the viscoelastic tube 2306 and the catheter 2115.

[0206] In some embodiments, Fig.33A As shown, the viscoelastic cartridge 2306 includes an optional spacer 2330, and a connector 2105 (e.g., Fig.31A The Luer connector shown) can include a hypodermic needle 2312 to pierce the septum 2330.

[0207] The viscoelastic cylinder 2306 may be housed in a single slide assembly (eg, Fig.33A ), or may have a separate attachment with a plunger spring 2304 (such as Figure 33B-Figure 33D ). Figure 33B-Figure 33D , which better illustrates the operation of the viscoelastic dispensing mechanism, thumb slide / trigger 2202 can be used to actuate inner catheter 2115 into and out of Schlemm's canal (eg, Fig.33C and Fig.33D ), and the dispensing button 2302 is used to dispense the fluid 2126 (e.g., viscoelastic material or other OVD fluid) from the viscoelastic cartridge 2306 (e.g., Fig.33D shown).

[0208] According to several embodiments, the cannula adapter described and illustrated herein may be configured with multiple sliding layers, such as Figure 34A-Figure 34C The multiple sliding layers may include three layers: a needle assembly 2420 including a sharp distal tip designed to penetrate the cornea; a cannula assembly 2440 including a tip designed to traverse the anterior chamber and penetrate the trabecular meshwork; and an inner catheter assembly 2460 having a blunt or rounded distal tip designed to traverse Schlemm's canal and the lumen for delivery of viscoelastics or other fluids. Fig.34A A cannula adapter 2400 (eg Fig.34E ) of the needle assembly 2420, Fig.34BA cannula assembly 2440 is shown, and Fig.34C Inner catheter assembly 2460 is shown.

[0209] Needle assembly 2420 and cannula assembly 2440 may include slots as shown. Needle assembly 2420 may include body 2422, lumen 2424, upper slot 2426, lower slot 2428, and needle 2430. Needle 2430 may be integrated with body 2422. Slots 2426, 2428 may be formed on body 2422 opposite to each other. In some embodiments, the positions of slots 2426, 2428 may be different from Fig.34A The example shown. The cannula assembly 2440 may include a body 2442, a lumen 2454, an upper slot 2446, a cannula slider 2448, and a tip 2450. The tip 2450 and the cannula slider 2448 may be integrated with the body 2442 so that the movement of the cannula slider 2448 may be converted into the movement of the body 2442 and the tip 2450. The upper slot 2446 may be formed on the body 2442. The inner catheter assembly 2460 may include a body 2462, a catheter slider 2464, and a catheter 2115. The catheter slider 2464 and the catheter 2115 may be integrated with the body 2462 so that the movement of the catheter slider 2464 may be converted into the movement of the body 2462 and the catheter 2115.

[0210] The operation and assembly of the three sliding layers of the cannula adapter 2400 are arranged in Figure 34E-Figure 34G Cannula assembly 2440 can be positioned within needle assembly 2420 such that upper slot 2446 of cannula assembly 2440 overlaps at least a portion of upper slot 2426 of needle assembly 2420, and cannula slider 2448 is positioned within lower slot 2428 of needle assembly 2420. Catheter assembly 2460 can be positioned within cannula assembly 2440 such that catheter slider 2464 is positioned within upper slot 2426 of needle assembly 2420 and upper slot 2446 of cannula assembly 2440, respectively.

[0211] As described herein, needle 2430 can penetrate the cornea of ​​the patient. Cannula slider 2448 can slide within slot 2428 of needle assembly 2420 to slide cannula assembly 2440 within needle assembly 2420. When cannula slider 2448 moves distally (e.g., toward the patient), end 2450 of cannula assembly 2440 can move distally and, for example, penetrate a superior trabecular meshwork (TM) portion of the patient. Slot 2446 of cannula assembly 2440 can overlap at least a portion of slot 2426 of needle assembly 2420 to allow catheter slider 2464 to slide distally (e.g., toward the patient) and proximally (e.g., away from the patient) within slots 2426, 2446. As catheter slider 2444 moves distally (eg, toward the patient), catheter 2115 can exit, for example, via a distal end of tip 2450 and, for example, enter and travel along Schlemm's canal. Fig.34D A close-up side view of the distal tip of catheter 2115 is shown. Fig.34D As shown, the catheter 2115 may include a rounded tip 2452 and a lumen 2454 that allows viscoelastic fluid or other fluid to flow therethrough.

[0212] Figure 34A-34G The three sliding layer assemblies shown and described in the drawings can advantageously eliminate the need for multiple separate surgical instruments, thereby simplifying the procedure.

[0213] Figure 35A-Figure 38B The internal components of various embodiments of the cannula adapters described herein are shown.As the inner catheter 2115 is fed through the outer cannula 2120, a significant challenge in catheter extension is preventing internal buckling. Figure 35A-Figure 38B Various internal support mechanisms are shown (which may be used alone, or one or more mechanisms may be combined together) that are designed to prevent buckling and guide the inner catheter 2115 along the outer cannula 2120.

[0214] Fig.35A and Fig.35B Shown are side views (undeployed and fully deployed configurations, respectively) of a cannula adapter 2500 that includes a collapsible helical strut 2152 having an inner diameter just larger than the inner catheter 2115 and whose outer diameter is limited by the housing 2110. The helical strut 2152 can have a spring force close to zero, yet still maintain radial stability.

[0215] Fig.36A and Fig.36BA side view of a cannula adapter 2600 is shown (in an undeployed configuration and a fully deployed configuration, respectively), which includes a rigid support sleeve 2154 having an inner diameter sized to fit the inner catheter 2115 and an outer diameter sized to slide within the outer cannula 2120. The rigid support sleeve 2154 can be formed of any suitable rigid material, such as 300 series stainless steel. In some embodiments, the use of the rigid support sleeve 2154 may cause the diameter of the outer cannula 2120 to increase.

[0216] Fig.37A and Fig.37B A side view of a cannula adapter 2700 is shown, which includes wheels 2701 and catheter feeders 2702, 2704. The catheter feeders 2702, 2704 can stabilize the catheter 2115 and prevent the catheter from bending when the catheter is moved distally (e.g., toward the patient) or proximally (e.g., away from the patient). The wheel 2701 can be coupled to the catheter feeder 2702 so that rotation of the wheel 2701 can be converted into rotation of the catheter feeder 2702. For example, as shown in FIG. Fig.37B As shown, counterclockwise rotation of wheel 2701 can cause clockwise rotation of catheter feeder 2702. Clockwise rotation of catheter feeder 2702 can cause catheter 2115 to traverse distally (e.g., toward the patient). Similarly, clockwise rotation of wheel 2701 can cause counterclockwise rotation of catheter feeder 2702, which can cause catheter 2115 to traverse proximally (e.g., away from the patient). In some embodiments, catheter feeders 2702, 2704 are coupled to each other such that rotation of one causes rotation of the other. For example, clockwise rotation of catheter feeder 2702 can cause counterclockwise rotation of catheter feeder 2704 (e.g., toward the patient). Fig.37B ). In some embodiments, movement of the catheter 2115 (e.g., distal movement or proximal movement) can cause rotation of the catheter feeder 2704. In some embodiments, the catheter 2115 can be retracted by simply pulling the assembly from the syringe 2125 (e.g., rather than rolling the wheel 2701 in a clockwise direction).

[0217] Fig.38A and Fig.38B A side view of a telescoping sleeve 2800 is shown (e.g., in an undeployed configuration and a fully deployed configuration, respectively) that provides support for the catheter 2115 while contracting during actuation, and which can be incorporated into any embodiment of a cannula adapter or fluid (e.g., a viscoelastic substance) delivery device described or illustrated herein.

[0218] Figure 39A-Figure 39FAn advancement mechanism 2900 is shown that can be used to advance the catheter 2115 into the outer cannula 2120. The advancement mechanism 2900 can be incorporated into any embodiment of the cannula adapter described or illustrated herein. The advancement mechanism 2900 can include a thumb control dial 2901 positioned near the distal end of the housing 2110 for easy one-handed operation by the operator.

[0219] The turntable 2901 can be rotated by the operator's thumb by interacting with a bump or protrusion 2904 extending upward from the turntable 2901. Alternatively, the bump or protrusion 2904 can include a dimple or indentation. The turntable 2901 can be operatively coupled to the proximal end of the inner catheter 2115 so that rotation of the turntable 2901, for example, in a clockwise direction causes the inner catheter 2115 to be advanced along the outer cannula 2120 in a controlled manner, then to the outside of the outer cannula, and to advance into and along the Schlemm's canal, and rotation of the turntable 2901, for example, in a counterclockwise direction causes the inner catheter 2115 to be retracted. Of course, these directions can be reversed as desired and / or required. The distal portion of the inner catheter 2115 can have a length adapted to match or correspond to (e.g., approximately equal to) a full 360 degree circumference of Schlemm's canal as described herein, and the distal portion of the inner catheter is adapted to extend beyond the distal tip of the outer cannula 2120 upon a full rotation (e.g., inner loop) of the turntable 2901. In some embodiments, a 360 degree rotation (e.g., inner loop) of the turntable 2901 may extend beyond the distal tip of the outer cannula 2120. Fig.39B and Fig.39D ) corresponds to 360 degrees of travel of the catheter 115 along Schlemm's canal. In addition, the distal portion of the inner catheter 2115 can include pre-formed (e.g., a shape-setting material having a defined radius of curvature corresponding to the radius of curvature of Schlemm's canal) or flexible material features, as described herein.

[0220] Turntable 2901 may include button 2902, which may be pressed by the thumb of the operator. Button 2902, when actuated (e.g., moved from an unactuated position to an actuated position), may cause the distribution of a viscoelastic substance or other viscous surgical fluid. For example, button 2902, when actuated, may cause (e.g., actuate) a control valve to distribute a viscoelastic substance or other viscous surgical fluid. Distribution of a viscoelastic substance or other viscous surgical fluid may be performed at a constant rate, at a variable rate based on the amount of the button 2902 being pressed, or at a predetermined push amount for each button press. In some embodiments, the actuation of button 2902 may actuate a pump, such as a positive displacement pump.

[0221] In some embodiments, the feeding mechanism 2900 can include indentations or detents positioned at the clock positions around the turntable 2901. The indentations or detents can provide the operator with an indirect indication of the azimuthal position of the catheter 2115 within Schlemm's canal without the need for actual visualization via an imaging modality. For example, the detents at each clock position can provide tactile feedback to the operator (e.g., false stops), or produce audible clicks to provide audible feedback to the operator. The operator can stop at a given clock position and dispense a given volume of viscoelastic or other fluid, then move to the next clock position.

[0222] The catheter 2115 can be made of one or more bonding materials, such as nylon / Polymer, polyimide, etc. The proximal end of the catheter 2115 can be overmolded (e.g., insert molded) or bonded (e.g., via an adhesive) to the turntable mechanism. The channel that feeds the catheter 2115 into the outer cannula 2120 can be a separately molded component or metal component, or can be formed together with the housing 2110 of the cannula adapter 2100. Fig.39E and Fig.39F 2901 can be incorporated into or assembled with the housing 2110. The inner conduit 2115 can be connected to the conduit 2115 via a separate section of the tubing 2906 (e.g. Fig.39E and Fig.39F ) or connected to a fluid delivery system (not shown) via a channel formed in a molded part, such as a valve or a syringe (such as those described herein). In some configurations, the valve can be directly integrated into the turntable mechanism.

[0223] The cannula adapters described and illustrated herein may be incorporated with a variety of different viscoelastic dispensing mechanisms or systems. Figure 40A-40C Shown with Figure 39A-Figure 39F The cannula adapter (feeding mechanism 2900) of the embodiment of the delivery system 3050 used in combination. The delivery system 3050 may include a reservoir 3001, a spring 3002, a connector 3004, a stop 3006 and a base member 3008. The reservoir 3001 (or cartridge) can be removably coupled (e.g., friction fit, corresponding mating features, latches and recesses, etc.) to the housing 2110 of the cannula adapter (feeding mechanism 2900). The reservoir 3001 may include a spring 3002 that can be retracted to a compressed position (or configuration) before use, such as Fig.40AAs shown. A stopper 3006 (e.g., a rubber stopper) can be positioned within and near the proximal end of the reservoir 3001 (e.g., the end opposite the feed mechanism 2900). A connector 3004 (e.g., a female Luer connector) can be placed at the distal end of the reservoir 3001 (e.g., the end proximal to the feed mechanism 2900) to facilitate direct connection to any standard viscoelastic syringe or other viscosurgical device (e.g., a pre-filled ophthalmic viscoelastic device 2125). In some embodiments (not shown), a septum can be present at the distal end of the reservoir 3001 that can be pierced by a needle or dispensing cannula.

[0224] The reservoir 3001 can be filled with a fluid 2126 (e.g., a viscoelastic substance or other ophthalmic viscosurgical device (OVD) fluid) by depressing the plunger of a standard viscoelastic syringe 2125. When the reservoir 3001 is filled, the stopper 3006 can be pushed back against the compression spring 3002. A deflation valve or air breathable material (such as a porous plastic or porous polymer material) can be integrated into the reservoir 3001 to allow further purging of air during filling. Once the desired amount of fluid 2126 (e.g., a viscoelastic substance or other fluid) is added to the reservoir 3001, the delivery system 3050 can be connected to the housing 2110 including the conduit 2115. Once the delivery system 3050 is connected to the housing 2110, the base member 3008 can be rotated to release the spring 3002, thereby applying a force to the stopper 3006. The spring 3002 can be operatively coupled to the base member 3008 so as to engage (e.g., compress and relax) the spring 3002 when the base member 3008 is actuated. In some embodiments, rotation of the base member 3008 can cause compression or relaxation of the spring 3002. According to several embodiments, Figure 40A-40C The delivery system 3050 can advantageously accommodate any selection of viscoelastic substances or other fluids and different amounts of viscoelastic substances or other fluids. The delivery system 3050 can ensure that a consistent spring force is applied to the reservoir 3001 as it is filled.

[0225] Reference Fig.41A and Fig.41B , a fillable cannula adapter 3100 is disclosed herein. Fig.41A and Fig.41BThe embodiment of the cannula adapter 3100 shown in the figure utilizes a screw drive (or threaded plunger) system, which can be incorporated into the housing 2110 of the cannula adapter 3100 or the housing of other embodiments of the cannula adapter described herein. The cannula adapter 3100 can include a threaded plunger 3112, a wheel 3110, a reservoir 3101, and a connector 3104 (e.g., a standard Luer connector or a check valve). The reservoir 3101 can be filled (e.g., primed) with a fluid 2126 from a syringe 2125 (e.g., a standard viscoelastic syringe), and a cap or other sealing member can be placed on the rear end of the reservoir 3101 prior to operation. The wheel 3110 can be located and positioned so that the wheel 3110 can be accessed via a slot formed in the belly (e.g., bottom or underside) of the housing 2110. When the housing 2110 is held in the operator's hand, the operator's thumb is placed on the turntable 2900, and the wheel 3110 can be conveniently positioned to be rotated by the operator's index finger or middle finger. The threaded plunger 3112 can be operatively and mechanically coupled to the wheel 3110 so that the threaded plunger 3112 is actuated by the rotation of the wheel 3110. The threaded plunger 3112 and the wheel 3110 may include a lumen that is fluidly coupled to a tubing (e.g., a flexible silicone tubing), which in turn is fluidly coupled to the lumen of the catheter 2115. In some embodiments, the lumen of the threaded plunger 3112 can be directly coupled to the lumen of the catheter 2115 without an intermediate tubing. When the threaded plunger 3112 pushes the reservoir 3101, the fluid 2126 (e.g., a viscoelastic substance or other ophthalmic viscosurgical device (OVD) fluid) is distributed back toward the catheter 2115 through the plunger 3112.

[0226] although Fig.41A and Fig.41B The fluid delivery system shown is coupled to the combined Figure 39A-Figure 9 3F describes and illustrates the feed mechanism 2900, but Fig.41A and Fig.41B The fluid delivery system of the invention can theoretically work with any suitable feed system embodiment. According to several embodiments, the catheter 2115 is capable of moving independently of the threaded plunger 3112 (e.g., via the feed mechanism 2900), so that the operator can dispense fluid at any time. This independent movement capability can be achieved by connecting the plunger sleeve (e.g., a sleeve extending through the lumen of the wheel 3110 and the plunger 3112) to the catheter 2115 via a flexible tubing (e.g., a silicone tubing) with a loose fit. The connection between the plunger sleeve and the catheter 2115 can alternatively be made of Polymer tubing or other more durable tubing may be used or a rigid tubing shaped like a spring to allow the catheter 2115 to move independently.

[0227] The connector 3104 (e.g., a female connector) can allow the operator to fill the reservoir 3101 with any standard viscoelastic syringe 2125, such as Figure 40A-40C Delivery system 3050 shown. The reservoir 3101 and the entire downstream system can be filled with a syringe 2125. The reservoir 3101 and the stopper 3106 (e.g., a rubber stopper) can be shaped so as to simplify the filling procedure and prevent unwanted trapped air. The operator can then remove the viscoelastic syringe 2125 and replace it with a plug or cap 3105. The plug or cap 3105 can be shaped to form the rest of the handle to be ergonomic. The cap 3105 can also have an extension that protrudes into the reservoir 3101 to clear any last bit of air from the connection when attached. Alternatively, the device can include a valve that can be closed when filling is complete.

[0228] The wheel 3110 of the housing 2110 (e.g., exposed on the belly of the housing 2110) can include a ratchet to provide an indication of the dispensed volume. For example, the ratchet can produce an audible click or tactile feedback each time the volume is increased. For example, the ratchet can be user-customizable so that the operator can choose to click once every 2uL or once every 5uL. Of course, other volume indications can be used as desired and / or required. In some embodiments, the belly (or lower surface) of the housing 2110 can include a plurality of spaced linear indicators that display the total volume dispensed so far or the volume remaining in the reservoir (e.g., reservoir 3101). For example, the mechanism can be driven by a coupling screw having a larger pitch to amplify linear motion, or driven on a gear and pinion system.

[0229] According to several embodiments, Fig.41A and Fig.41B The cannula adapter 3100 shown in the figure can advantageously include a fluid delivery system configured for one-handed use, which should be familiar to the operator. The fluid delivery system also allows the viscoelastic or other fluid to be dispensed at any time, rather than being coupled to the movement of the inner catheter, thereby allowing the operator to move past barriers or obstacles that the inner catheter would encounter or contact as it travels along Schlemm's canal.

[0230] Figure 42A-42BAn embodiment of a delivery system 3250 that can be incorporated into the cannula adapter described herein is shown. The delivery system 3250 can advantageously allow for controlled microbolus dispensing. The delivery system 3250 can include a resilient (e.g., compliant) cannula 3210 that is primed by closing a distal end 3214 of the cannula 3210 and opening a proximal end 3212 of the cannula 3210 toward a pressurized (e.g., spring-loaded) reservoir 3200. The reservoir 3200 can include a spring 3202 and a stop 3204, the structural and operational features of which are similar to those of the cannula adapter incorporated herein. Figure 40A-40C The conveying system 3050 described. Fig.42A After filling the sleeve 3210 as shown, the operator can flip a switch (not shown) to close the proximal end 3212 and open the distal end 3214, thereby expelling the elastic sleeve 3210 through the catheter 2115. The length, diameter and stiffness of the elastic sleeve 3210 can be varied to achieve a desired bolus volume.

[0231] The opening and closing of the proximal end 3212 and the distal end 3214 can be facilitated by causing the controller to move the block 3220 between different positions. For example, the block 3220 can have a first position (eg, Fig.42A as shown) and a second position (as Fig.42B 3210 ). When the block 3220 is in the first position, the first opening 3222 of the block 3220 can fluidly connect the reservoir 3200 and the proximal end 3212 of the cannula 3210, while the second opening 3224 can be offset from the distal end 3214 to fluidly disconnect the distal end 3212 from the conduit 2115. In this way, when the block 3220 is in the first position, the fluid 2126 (e.g., viscoelastic or other ophthalmic viscosurgical device (OVD) fluid) stored in the reservoir 3200 can enter the cannula 3210 via the proximal end 3212 and fill the cannula 3210 to the distal end 3214. When the block 3220 is in the second position, the first opening 3222 can be offset from the proximal end 3212 to fluidly disconnect the reservoir 3200 and the proximal end 3212, while the second opening 3224 can fluidly connect the distal end 3214 and the conduit 2115. As such, when the block is in the second position, fluid stored within the sleeve 3200 (eg, between the proximal end 3212 and the distal end 3214 ) can be discharged into the conduit 2115 via the second opening 3224 .

[0232] Figure 43A-43C An embodiment of a peristaltic fluid delivery system 3300 is shown. The peristaltic fluid delivery system 3300 may include an elastic (or compliant) sleeve 3320 and a peristaltic pump 3310 (eg, a protrusion 3350, such as a roller or ball bearing) Fig.43B and 43C33), the projections 3350 are adapted to sequentially compress or squeeze the sleeve 3320 at spaced locations along the length of the sleeve 3320 to transfer liquid between the fluid reservoir 3300 storing the fluid 2126 and the conduit 2115. At least the projections 3350 and a portion of the sleeve 3320 can be enclosed in a circular pump housing 3360. The peristaltic pump 3310 can be a rotary peristaltic pump (as shown) or a linear peristaltic pump.

[0233] In the illustrated embodiment, the sleeve 3320 can be positioned within the pump housing 3360 around a protrusion 3350 (e.g., a ball bearing) on ​​the rotor 3352. The pump housing 3360 can be actuated (e.g., pushed toward the rotor 3352) to clamp (e.g., compress) at least a portion of the sleeve 3320 with the protrusion 3350. When the pump housing 3360 is actuated, the rotation of the rotor 3352 forces the fluid 2126 to flow downstream along the sleeve 3320. As each of the pump elements 3350 disengages from the sleeve 3320, fluid flow is induced into the corresponding portion of the sleeve 3320. Fig.43B and Fig.43C A cross-sectional view of a peristaltic pump 3310 is shown. The peristaltic fluid delivery system 3300 can be primed (e.g., allowing fluid 2126 to enter the cannula 3320) before the cannula 3320 engages the pump element 3350. In some embodiments, the pump 3310 can be actuated after priming by rotating the rotor 3352.

[0234] Fig.44Various concepts related to catheter shape and features are shown to facilitate visualization or tracking of the catheter when the catheter 2115 is advanced along Schlemm's canal. The key challenge of viscous delivery or other fluid delivery procedures is to know where the end of the inner catheter is so that the end does not migrate to an undesirable anatomical structure (such as, when the target is Schlemm's canal, the anatomical structure is the suprachoroidal space). The top image shows a standard catheter lumen. The second image from the top shows that the distal end of the inner catheter may include a bulbous end. The bulbous end can be achieved by overmolding the material onto the extruded lumen. With reference to the third image in the middle, the catheter itself (e.g., catheter 2115) can be formed using a polymer with a phosphorescent colorant so that the catheter can be loaded with a microscope light source or an ultraviolet light source / blue light source, which can then glow when the light dims. The operator can alternatively attach a UV light source / blue light source to a surgical microscope, which can be turned on during surgery to better observe the phosphorescent catheter. In the embodiment shown in the fourth image (second from the bottom), the catheter includes a bulbous distal end colored with a phosphorescent colorant (e.g., a luminous material such as strontium aluminate). The bulbous end can be overmolded over the distal end of the extruded lumen. The final image at the bottom shows that the catheter 2115 can include contrasting marks 3400 spaced along the length of the inner catheter to facilitate visualization of the inner catheter (e.g., to more clearly indicate which part of the inner catheter you are seeing through the trabecular meshwork). The distal end can include more extensive (e.g., longer or wider) contrasting marks to indicate the distal end of the inner catheter. The cannula adapter described herein can be designed for use without a fiber optic cable to reduce costs.

[0235] Fig.45A and Fig.45B The operation of the outer cannula 3500 is schematically illustrated, and the outer cannula utilizes a shape memory material (e.g., Nitinol or other shape memory alloy material) to form a shape setting distal end 3520. The distal end 3520 of the cannula can be straight when constrained by an introducer needle 3510 (e.g., 304 stainless steel material, other 300 series stainless steel material, or other material), but will bend into a set shape when no longer constrained (e.g., constrained by the introducer needle). This shape setting configuration allows the outer cannula 3500 to slide within the rigid introducer needle 3510, but when slid forward beyond the introducer needle 3510, the outer cannula bends to enter Schlemm's canal.

[0236] Fig.46An embodiment of the distal end portion (e.g., distal tip) of the outer cannula 2120 is shown. As shown, the distal end portion (e.g., distal tip) can include a notch 3600 in the tubing to allow the cannula 2120 to articulate in a particular direction. In some embodiments, the distal end portion (e.g., distal tip) is connected to a pull wire so that an operator can control the articulation of the cannula 2120 near the notched distal tip. In some embodiments, the tip of the outer cannula 2120 can be configured to be placed or anchored to the posterior wall of Schlemm's canal to prevent accidental movement of the tip during, for example, a viscous or other fluid delivery procedure.

[0237] Reference Figure 47A-47H , an embodiment of a cannula adapter or fluid delivery device 3700 is disclosed. The cannula adapter 3700 may include a housing 2110 having two portions 2110A, 2110B, a first slider 3702, a second slider 3704, a channel 3703, a fluid delivery conduit 3716, a stopper 3790, and a distal end 3706 having two portions 3706A, 3706B. The distal end 3706 may include an opening sized to receive the cannula 2120. The first slider 3702 may be mechanically and / or operatively coupled to a reservoir 3780 and a plunger 3712. The second slider 3704 may include an insert 3740, which may be formed, for example, on the underside of the second slider 3704.

[0238] The fluid delivery conduit 3716 may include a proximal base 3709, a body 3708, and a sleeve 3714. The fluid delivery conduit 3716 may be positioned within an insert 3740 of the second slider 3704 (eg, Figure 47H 3709 and the body 3708 are positioned within the insert 3740 of the second slider 3704. The cannula 3714 of the fluid delivery conduit 3716 can be operatively coupled to the catheter 2115 such that distal and proximal movement of the fluid delivery conduit 3716 can move the catheter 2115 distally or proximally. In some embodiments, the cannula 3714 is directly coupled to the catheter 2115. In some embodiments, the cannula 3714 is indirectly coupled to the catheter 2115 via an intervening cannula. The cannula 3714 is fluidically coupled to the catheter 2115.

[0239] The fluid delivery conduit 3716 can allow fluid (e.g., a viscoelastic fluid) to flow from the reservoir 3780 to the conduit 2115. Fig.47D and Fig.47EAs shown, the body 3708 of the fluid delivery conduit 3716 can include a hole 3720 that can receive a plunger 3712 that can slide within the hole 3720 of the body 3708. The plunger 3712 can include a lumen 3722 that can allow a fluid (e.g., a viscoelastic fluid) to flow through the plunger 3712, into the hole 3720 of the fluid delivery conduit 3716, and through the cannula 3714 toward the catheter 2115.

[0240] During operation, the first slider 3702 and the second slider 3704 can move together distally (e.g., toward the distal end 3706) along the channel 3703. As described herein, the distal movement of the second slider 3704 can cause the distal movement of the fluid delivery conduit 3716 (e.g., toward the distal end 3706), which in turn can cause the catheter 2115 to move distally and outside the cannula 2120. Figure 1 In the example shown in FIG. 5F , the operator may penetrate the superior trabecular meshwork (TM) portion with the distal portion 2121 of the cannula 2120 and slide the first slider 3702 and the second slider 3704 to guide the catheter 2115 out of the cannula 2120 and into Schlemm's canal (SC).

[0241] Once the catheter 2115 is extended out of the cannula 2120 (e.g., directed into Schlemm's canal (SC)), the first slider 3702 may be used to dispense the fluid (e.g., a viscoelastic fluid) stored in the reservoir 3780. To dispense the fluid stored in the reservoir 3780, the first slider 3702 may be moved proximally (e.g., away from the distal end 3706) along the channel 3703 and then moved distally (e.g., toward the distal end 3706) along the channel 3703 relative to the second slider 3704. In some embodiments, the second slider 3704 remains stationary (e.g., to ensure that the catheter 2115 does not move) while the first slider 3702 moves along the channel 3703 to dispense the fluid (e.g., fluid 2126) stored in the reservoir 3780. When the first slider 3702 moves proximally along the channel 3703 relative to the second slider 3704, the plunger 3712 can move proximally within the hole 3720 of the body 3708 of the fluid delivery conduit 3716. The proximal movement of the plunger 3712 within the hole 3720 (e.g., relative to the fluid delivery conduit 3716) can cause the fluid stored in the reservoir 3780 to flow through the ball 3730 and the gasket 3731 into the lumen 3722 of the plunger 3712 and into the hole 3720 of the fluid delivery conduit 3716. Once the fluid flows into the hole 3720 of the fluid delivery conduit 3716, the plunger 3712 can move distally along the channel 3703 to force the fluid to flow out of the hole 3720 and into the cannula 3714. In some embodiments, the bulb 3730 (and the gasket 3731 ) can limit the amount of fluid that flows from the reservoir 3780 and into the lumen 3722 of the plunger 3712 .

[0242] In some embodiments, an operator (e.g., a clinician, surgeon, caregiver) can change the amount of fluid dispensed by changing the distance that the first slider 3702 travels along the channel 3703. For example, the further the first slider 3702 moves proximally (e.g., toward the operator) along the channel 3703, the more fluid is dispensed via the catheter 2115, and vice versa. In some embodiments, the channel 3703 (or the first slider 3702) can include a detent that can provide tactile feedback about how far the first slider 3702 has moved proximally (e.g., toward the operator) along the channel 3703 to indicate how much fluid will be dispensed when the first slider 3702 moves back distally along the channel 3703.

[0243] The ball 3730 and the gasket 3731 can together act as a check valve for the plunger 3712. The ball 3730 and the gasket 3731 can allow fluid (e.g., fluid 2126) to be dispensed from the reservoir 3780 while preventing the fluid (e.g., fluid 2126) from flowing backward (e.g., toward the reservoir 3780) through the ball 3730 and the gasket 3731. Thus, once the fluid flows through the ball 3730 and the gasket 3731, the fluid cannot flow back into the reservoir 3780. In some embodiments, other types of suitable valves can be used to provide one-way flow of fluid (e.g., fluid 2126) out of the reservoir 3780 and through the plunger 3712.

[0244] In some embodiments, a user may experience increased resistance when sliding the second slider 3704 back and forth to dispense fluid from the reservoir 3780, compared to sliding the first slider 3702 to move the catheter 2115 out of the cannula 2120. This resistance may be caused by greater friction between the second slider 3704 and the first slider 3702 (and the channel 3703) than between the first slider 3702 and the channel 3703. This resistance difference may provide, for example, tactile feedback that may allow a user to distinguish between a catheter dispensing motion (e.g., sliding the first slider 3702) and a fluid dispensing motion (e.g., sliding the second slider 3704).

[0245] In some embodiments, the second slider 3704 may include a groove 3705 through which the first slider 3702 may move (e.g., slide) distally or proximally. The first slider 3702 and the second slider 3704 may include a ridge 3752 and a groove 3750, which may provide a better grip for an operator (e.g., a caregiver).

[0246] In some embodiments, the cannula 2120 may include a protrusion 3755 that can fixedly attach the cannula 2120 to an insert (e.g., Fig.47F 21). As such, the distal end 3706 can be rotated to change the orientation of the cannula 2120, and thus change the orientation of the distal portion 2121 of the cannula 2120. This can advantageously allow an operator to change the orientation of the cannula 2120 by rotating the distal end 3706 without having to change the orientation of the cannula adapter 3700 (e.g., rotating about an axis parallel to the length of the cannula adapter).

[0247] The cannula adapter 3700 may include a stopper 3790 that may be placed inside the channel 3703. The stopper 3790 may prevent the first and second slides 3702, 3704 from moving distally during, for example, storage or operation. This may advantageously prevent the catheter 2115 from accidentally or unintentionally extending out of the cannula 2120.

[0248] like Fig.47E As shown in the example of FIG, a gasket 3710 can be placed inside a base 3709 of a fluid delivery conduit 3716. The gasket 3710 can be sized to fit snugly within the base 3709 and include an opening (e.g., a circular opening) to receive the plunger 3712. In some embodiments, the gasket 3710 can contact the outer surface of the plunger 3712 to create sufficient resistance so that the plunger 3712 moves smoothly and in a controlled manner within the hole 3720 of the body 3708.

[0249] Figure 48A-48D Various views of the cannula 2120 and the catheter 2115 are shown. As described herein, the cannula 2120 may include a distal portion 2121 that may penetrate the superior trabecular meshwork (TM) portion with a tip 3800 and an end surface 3804. The end surface 3804 may be formed at an angle (e.g., skewed) relative to an axis parallel to the body of the cannula 2120. The surface 3804 may facilitate, for example, penetration of the superior trabecular meshwork (TM) portion. In some embodiments, the end surface 3804 may be orthogonal (or substantially orthogonal) relative to an axis parallel to the body of the cannula 2120. The tip 3800 may form an inclined distal tip to facilitate forming a cutting edge. The distal portion 2121 may be curved to allow the catheter 2115 to extend out (e.g., exit) from the lumen 3802 of the cannula 2120 at an angle, which may facilitate movement of the catheter 2115 into and around the Schlemm's canal (SC). The catheter 2115 can include a distal end 3810 (eg, tip) having a tapered edge 3812. The tapered edge 3812 can facilitate and guide movement of the catheter 2115 within the curved distal portion 2121 and within Schlemm's canal (SC).

[0250] Figure 48E-48HOther examples of distal portions 2121 of cannula 2120 are shown. Distal portion 2121 may include one or more cuts 3852 that may be formed at end 3800 of distal portion 2121 to provide one or more cutting edges or surfaces. In some embodiments, cuts 3852 may be formed on a distal edge of distal portion 2121 (e.g., an edge of a portion of cannula 2120 proximal to distal portion 2121). In some embodiments involving multiple cuts 3852, cuts 3852 may be formed adjacent to each other (e.g., as in Figure 48G and Figure 48H ). The cutout 3852 may include an anchor 3854 that may abut against a surface (e.g., the posterior wall of Schlemm's canal) and stabilize the cannula 2120 (e.g., prevent the distal portion 2121 of the cannula 2120 from moving around) during the process of dispensing fluid via a catheter (e.g., catheter 2115). In some embodiments, during use, the anchor 3854 may penetrate a tissue surface (e.g., the posterior wall of Schlemm's canal). Figure 48E-48H The illustrated distal portion 2121 may be incorporated into any of the embodiments of the cannula 2120 described herein.

[0251] Fig.49A and Fig.49B An example operating scheme of the cannula adapter 3900 is shown. The cannula adapter 3900 can include a slider 2202, a cannula 2120, a dispensing mechanism 3902, and a reservoir 3904. The operator can slide the slider 2202 distally (e.g., toward the patient) to guide, for example, a catheter out of the cannula 2120 and into Schlemm's canal. Subsequently, the operator can actuate the reservoir 3904 to dispense the fluid into and out of the catheter 2115. In some embodiments, the dispensing mechanism 3902 can include a fixed plunger positioned within the reservoir 3904 that pushes the fluid out of the reservoir 3904 when the reservoir 3904 is rotated about an axis parallel to the length of the cannula adapter 3900. In some embodiments, the dispensing mechanism 3902 can include a plunger positioned within the reservoir 3904 and connected to a resilient member (e.g., a spring) that can push the fluid out of the reservoir 3904 and toward the catheter 2115 when, for example, the proximal end of the reservoir 3904 is pushed distally (e.g., toward the patient).

[0252] According to several embodiments, prior to filling, trypan blue or some other biocompatible dye (e.g., brilliant blue, indocyanine green, fluorescein) is introduced into reservoir 2164. Introducing a biocompatible dye can allow the operator to observe the extent of dilation of Schlemm's canal and the downstream episcleral venous network.

[0253] Several additional features can be integrated with the above concepts. For example, wound sealing features located on the outside of the outer cannula 2120 or the introducer needle, such as a compliant / elastomeric overmold or an O-ring, which fits within or presses against the corneal incision during surgery to prevent aqueous humor leakage. Alternatively, a balanced salt solution (BSS) infusion path through the outer cannula 2120 can be used to provide chamber stability.

[0254] Although primarily described with respect to the delivery of viscoelastic substances within Schlemm's canal, the devices and methods described and illustrated herein can be used to deliver viscoelastic substances or other fluids to other pre-existing or created anatomical pathways, passages, spaces, lumens or vessels associated with the eye (e.g., collector channels, downstream episcleral venous networks, tissue bundles of the eye, suprachoroidal space, subconjunctival space, subretinal space) or other locations other than the eye. Fluids other than viscoelastic fluids can be used (e.g., other liquid drugs, medicaments, solutions, chemicals, etc.).

[0255] In aspects of the present disclosure, an ophthalmic viscoelastic surgical device (OVD) may be connected to the device via a cannula with nurse activated delivery.

[0256] In various aspects of the present disclosure, an OVD can be provided as a pen cap OVD for viscoelastic solutions used in eye surgery. For example, an integral handle has a fluid reservoir completely located therein. As another example, the OVD can be pre-packaged in an attachable (e.g., click-on) device, where it can be clicked into the handle or connected via a needle. Further click OVD devices can be connected via needleless connectors using duckbill valves, pointed valves, or maxplus valves. In some examples, the OVD can be loaded into a barrel in an operating room, which can then click the device.

[0257] In various aspects of the present disclosure, an ophthalmic device (e.g., cannula adapter 3900, ophthalmic device 4000) may be provided in which the distal end 3810 (e.g., tip) of the catheter 2115 or even the entire length of the catheter 2115 has a side port 2123 (e.g., hole), or the catheter 2115 is porous or braided (e.g., like a heart stent). Here, the very distal end 3810 may have no holes or have holes 2123a (see FIG. 21) sized to allow pressure to build up within the catheter 2115. Fig.50 ), causing the viscoelastic solution to flow through the wall of the catheter 2115 and create pressure around the catheter 2115 (e.g., creating pressure inside Schlemm's canal, stretching the trabecular meshwork, and enlarging the collector channel).

[0258] In various aspects of the present disclosure, the O-ring 2124 can form a confined fluid zone (e.g., a localized pressure buildup), such as Fig.51 In various aspects of the present disclosure, a sinusoidal outer diameter may be used in place of or in addition to the O-ring 2124. Fig.51 As shown in the top view of FIG. 21 , the OVD 2129 is located lateral to the distal end 3810 of the catheter 2115, and the viscoelastic solution (eg, viscous fluid) flows outward from the catheter 2115 / cannula 2120. Fig.51 As shown in the bottom figure of , O-ring 2124 acts as a barrier to the outflowing viscous fluid to flow back further along the catheter 2115 / cannula 2120, thereby providing pressure to the area between the tip 3810 and the O-ring barrier. Another method is to press down with the outer tip 3810 of the device (e.g., press down on the TM) to form a reservoir and then pump in fluid to expand.

[0259] In various aspects of the present disclosure, an ophthalmic device is inserted transcavitary (e.g., through the AC), a catheter / cannula is entered through the TM, and the catheter extends along the SC. The tip of the device has the ability to deliver fluid when the catheter is stationary, upright, or retracted. The tip of the device can deliver fluid radially (e.g., a distance equal to 1-2 o'clock).

[0260] In various aspects of the present disclosure, O-rings, gaskets, or larger flexible sleeves can create confined areas for localized high pressure for specific anatomy (e.g., toward the collector channel or toward the TM). Other features that may affect ophthalmic devices are handpiece design, catheter extension / retraction, fluid delivery and pressure regulation, and removable fluid reservoirs.

[0261] In aspects of the present disclosure, the ophthalmic device may be adapted to deliver one or more drugs in place of or in combination with an OVD.

[0262] In various aspects of the present disclosure, an ophthalmic device may include a catheter that can be severed from the device to become an ocular implant. For example, an ophthalmic device may be used to deploy a catheter, deliver an OVD and / or medication, and sever the catheter from a handheld device (e.g., where the catheter enters the TM). The remaining unsevered catheter is bioresorbable, so it is not used as a long-term implant. The severed portion of the catheter is suitable as a long-term implant.

[0263] One problem with current cannulation catheters is the ease with which the catheter 3120 can be guided into the canal. Fig.52 In various aspects of the present disclosure, the ophthalmic device 3900 may include a leading feature 3123 disposed on the bulb 3122 of the distal tip 3121 to allow the catheter 3120 to more easily enter the tube, and then the rest of the tube will follow. For example, the leading feature 3123 may be a flat surface that enters first (e.g., like a shoe horn), such as Fig.52 Here, the flat portion 3123 will abut against the front wall of the tube. The leading feature 3123 can also be as shown in the middle figure of FIG. Fig.52 In aspects of the present disclosure, rather than current methods of using a blade to make the initial slit or using the end of an insert to make the initial stab incision, a leading feature 3123 can be used for initial entry into the tube (e.g., partially supported by an insert that holds the flat edge in a rigid manner so that it firmly engages the TM but is still supported by the surrounding metal of the insert itself).

[0264] like Fig.53 As shown, catheter 3130 can be used for a variety of purposes, such as for injecting fluids and also for supplying / injecting and placing sutures. Fig.53 As shown in the top depiction of , the catheter 3130 can have a distal hole 3134 (e.g., a hole located at the leading end 3131) that allows fluid (e.g., a viscous fluid) to flow out of the distal hole 3134 and out of the orifice 3133 on the side wall of the catheter 3130. Fig.53As shown in the bottom depiction of the catheter, the suture 3135 can be set in the catheter lumen 3136, and the end ball 3132 of the suture 3135 can be flush with the distal hole 3134 of the catheter 3130 and / or block the distal hole of the catheter. Any suitable structure can be used to replace the end ball, such as a hook. Here, as the ball 3132 of the suture 3135 covers the distal hole 3134, any fluid flushed through the lumen 3136 around the suture 3135 in the lumen 3136 will flow out from the orifice 3133 on the side of the catheter 3130. In various aspects of the present disclosure, a fluid flushing operation on the catheter 3130 can be performed, and then the suture 3135 can be inserted into the catheter 3130 to inject / place the suture 3135, or vice versa.

[0265] In various aspects of the present disclosure, the catheter 3130 can be inserted 360 degrees into Schlemm's canal, and then the bulb 3132 of the suture 3135 can be fixed while the catheter 3130 is withdrawn, thereby leaving the suture 3135 while the catheter 3130 is removed from the eye. Here, for example, the suture 3135 can be knotted or the suture 3135 can just be left in place. In various aspects of the present disclosure, once the 360-degree insertion is completed, the catheter 3130 can be cut and left in place. In various aspects of the present disclosure, the catheter 3130 can be inserted first to perform viscous expansion by injecting a viscous substance, and then the catheter 3130 can be removed, and the suture 3135 can be inserted 360 degrees and left in place. Here, the catheter 3130 can be inserted using a device handpiece, and then the catheter 3130 can be replaced with a suture 3135 in the device handpiece so that the suture 3135 can be inserted / placed using the same device handpiece. For example, after use, the catheter 3130 can be retracted into the stainless steel sleeve, and then the suture 3135 can be fed out of the stainless steel sleeve. In various aspects of the present disclosure, the device handpiece can be configured only for the introduction of sutures 3135, and not for the use of the catheter 3130.

[0266] In various aspects of the present disclosure, the suture 3135 can be affixed to the exterior of the catheter 3130, rather than being disposed within the lumen 3136 of the catheter 3130. This provides an advantage in that the catheter 3130 can be inserted once and used for both adhesive dilation and suture 3135 placement. Fig.54 As shown, the catheter 3130 can have an axial notch 3137 (e.g., a slot) in the outer sidewall so that the suture 3135 can be disposed in the notch 3137 so that the combined diameter of the suture 3135 and the catheter 3130 within the slot 3137 is the same as the diameter of a typical catheter. In various aspects of the present disclosure, the catheter 3130 can have an outer ring notch 3138 to tie the suture 3135 around, if needed or desired.

[0267] like Fig.55 As shown, in various aspects of the present disclosure, the ball 3132 of the suture 3135 can be combined with the sewing ring 3139 to lock the suture 3135 in place. For example, the sewing ring 3139 can be located at one end of the 360-degree loop, and the ball 3132 can be located at the other end of the 360-degree loop, so that once the ball 3132 and the ring 3139 are combined, the 360-degree suture loop remains in place.

[0268] like Fig.56 As shown, in various aspects of the present disclosure, the suture 3135 can be configured as a wave. Here, the wave suture 3135 provides bunching or tightening of the TM independently of the tying or tensioning of the suture. The suture 3135 can have a shape such as Fig.57 The barbs shown provide maximum tensioning or anchoring strength for the suture 3135 .

[0269] like Figure 58A-Figure 58D As shown, in various aspects of the present disclosure, a guide wire 4140 and a tensioning suture 4135 can be inserted into the eye 115. Fig.58A As shown, the ophthalmic device 4000 ( Fig.64 ) cannula 4120 can be inserted into the eye 115 and aligned with the tube 108 (e.g., Schlemm's canal). Then, the guide wire 4140 can pierce the tube 108 and be extended to pass through the tube 108 to encircle the circumference of the eye 115, such as Fig.58B As shown. Fig.58C As shown, the catheter 4150 can be inserted and extended to follow the guide wire 4140 around the circumference through the tube 108. In various aspects of the present disclosure, the catheter 4150 can inject or dispense a fluid (e.g., a viscous fluid) as it moves through the tube 108. The guide wire 4140 can then be disconnected from the ophthalmic device 4000, leaving the guide wire 4140 positioned throughout the tube 108 surrounding the eye 115, as shown. Fig.58D Here, the disconnected guidewire 4140 can provide inward tension.

[0270] In various aspects of the present disclosure, the guidewire 4140 can be configured to be slightly smaller than the diameter of the tube 108. In various aspects of the present disclosure, the guidewire 4140 can be formed of any suitable material (e.g., superelastic nitinol). In various aspects of the present disclosure, the guidewire 4140 can extend greater than 360 degrees so that the ends of the guidewire 4140 overlap, such as Fig.58D As shown, to avoid or minimize stress concentration and / or tearing at the end of the guide wire 4140. In various aspects of the present disclosure, before inserting the wire 4170 ( Fig.59), such as if it is not beneficial to guide the catheter 4150 over the guidewire 4140, the catheter 4150 can extend through the tube 108 around the circumference of the eye 115. Here, the wire 4170 can be deployed after the catheter 4150 is fully inserted.

[0271] In various aspects of the present disclosure, a simple push wire 4160 can be supported by the inner diameter of the catheter 4150 to facilitate deployment of the wire 4170 (e.g., extending the wire 4170 through the tube 108), such as Fig.59 Here, the push wire 4160 may not be retractable into the catheter 4150, so any suitable means of cutting or severing the push wire 4160 and / or wire 4170 may be used so as to leave the push wire 4160 and / or wire 4170 in the tube 108.

[0272] like Fig.60A and Fig.60B As shown, any suitable tensioning device 4180 may be used as the wire implanted in the tube 108 of the eye 115. For example, the tensioning device 4180 may be a shape memory polymer spiral coil suture 4180a deployed into the tube 108 so that body temperature in the eye 115 can activate the suture 4180a and cause it to contract in an arcuate shape against the trabecular meshwork 106 and stretch the suture 4180a toward the anterior chamber 100.

[0273] like Figures 62A to 62C As shown, the spiral coil suture 4180a disposed in the tissue 4185 is shown in different stages of contraction. Here, Fig.62A The shape memory polymer suture 4180a in may have just been placed in the tube 108 and may therefore be at a temperature of 20 degrees Celsius. Fig.62B In the embodiment of the present invention, the body temperature in the eye 115 can warm the shape memory polymer suture 4180a to 37 degrees Celsius, causing the shape memory polymer suture 4180a to contract. Fig.62C As shown, when the temperature rises to 40 degrees Celsius, the shape memory polymer suture 4180a can further shrink.

[0274] like Fig.61 As shown, the tensioning device 4180 can be a shape memory polymer sleeve 4180b that expands when deployed into the catheter 108. Here, the body temperature of the eye 115 again activates the shape memory polymer sleeve 4180b to expand against the tube 108 and stretch the trabecular meshwork 106 and stretch the shape memory polymer sleeve 4180b toward the anterior chamber 100. In aspects of the present disclosure, for example, the tensioning device 4180 can be a nitinol wire overmolded in silicone.

[0275] In such Figure 63A-63CIn yet another example shown, the tensioning device 4180 may be a shape memory polymer cylindrical device 4180c. Fig.63A As shown, the SMP cylindrical device 4180c can be in a temporarily packaged state (e.g., in an initially placed position in the tube 108). Fig.63B In the embodiment of the present invention, the shape memory polymer cylindrical device 4180c can be in a partially recovered state (e.g., after being activated by the body temperature of the eye 115). Fig.63C In the embodiment of the present invention, the shape memory polymer cylindrical device 4180c can be in a fully recovered state (e.g., after being fully activated by the body temperature of the eye 115).

[0276] In various aspects of the present disclosure, the tensioning device can be formed of a shape memory polymer and / or a shape memory alloy. In various aspects of the present disclosure, the tensioning device can be an injectable bioerodible or biodegradable stent device that dissolves or disappears after a set period of time (e.g., 1 week or longer).

[0277] In various aspects of the present disclosure, the tensioning device can be a suture that is folded upon itself at least once, braided, or that maintains a framework that allows the viscoelastic to bridge the suture material and be retained for subsequent steps. In various aspects of the present disclosure, the viscoelastic can be placed onto the folded suture such that the viscoelastic is retained between the strands of the suture prior to placing the suture in the inserter, and then the combined suture and viscoelastic is inserted into Schlemm's Canal (e.g., the suture and viscoelastic can be inserted and retained in the canal for a long period of time).

[0278] In various aspects of the present disclosure, a shape memory sleeve and / or shape memory suture can be selectively expanded along its length, wherein when a portion of the sleeve / suture is expanded along 90 degrees, the 0 degree and 90 degree portions of the sleeve / suture can be pressed against the outer wall of Schlemm's canal, while the 45 degree portion of the sleeve / suture can stretch the TM toward the AC.

[0279] In various aspects of the present disclosure, the ophthalmic device may include one or more lumens. In various aspects of the present disclosure, the ophthalmic device may include slots of different sizes and / or shaped holes. In various aspects of the present disclosure, the ophthalmic device may include forward, backward, or forward and backward (e.g., relative to the end) delivery of OVD. In various aspects of the present disclosure, the ophthalmic device may include a dynamically shaped front portion to help traverse the tube. In various aspects of the present disclosure, the ophthalmic device may include click wheel delivery (e.g., similar to a computer mouse). In various aspects of the present disclosure, the ophthalmic device may include a dynamic delivery button (e.g., not a click, but can be titrated based on how far the button is pressed). In various aspects of the present disclosure, the ophthalmic device may include a sealing feature to help contain viscous fluids. In various aspects of the present disclosure, the ophthalmic device may include the ability to adjust the delivery volume on the handpiece.

[0280] like Fig.64 As shown, the ophthalmic device 4000 has a housing 4100 and a cannula 4120 extending from the housing 4100. An activation assembly 4200 may be disposed on and / or within the housing 4100. The activation assembly 4200 may include a wheel 4210 (e.g., a roller) configured to rotate around an appropriate position within the housing 4100. A movable housing ring 4220 may be disposed on the housing 4100 around some or all of the wheels 4210. The movable housing ring 4220 may be coupled to the wheels 4210 such that when the wheels 4210 are pushed inwardly into the housing 4100, the movable housing ring 4220 and the wheels 4210 move in tandem.

[0281] The fixed housing ring 4230 can be disposed on the housing 4100 around some or all of the movable housing ring 4220. The fixed housing ring 4230 remains fixed to the housing 4100 and thus remains in a fixed position as the movable housing ring 4220 moves inwardly and outwardly. For example, when pressure on the wheel 4210 is released, the wheel 4210 is pushed inwardly or biased outwardly (e.g., popped out). In various aspects of the present disclosure, the housing 4100 itself can be disposed around the movable housing ring 4220 instead of some or all of the fixed housing ring 4230.

[0282] The haptic portion 4300 may be disposed on the housing 4100, or may be formed as a part of the housing 4100. For example, the haptic portion 4300 may be a soft-touch rubber coating configured to provide a firm and ergonomic grip on the ophthalmic device 4000. The haptic portion 4300 may be formed of any suitable material (e.g., rubber, silicone) and may be disposed on the housing 4100 by any suitable process (e.g., overmolding, molding, welding, bonding).

[0283] In use, the ophthalmic device 4000 can be grasped by the user's hand, wherein rotation of the wheel 4210 may cause a wire (e.g., a guidewire 4140) or a catheter (e.g., a catheter 4150) to extend or retract from the cannula 4120. For example, a finger or thumb of the user may be used to roll the wheel 4210 forward to extend the guidewire 4140 and / or the catheter 4150. Similarly, for example, the wheel 4210 may be rolled backward to retract the guidewire 4140 and / or the catheter 4150. In addition, the user may push the wheel 4210 inwardly so that the wheel 4210 and the movable housing ring 4220 are displaced inwardly into the housing 4100, which may, for example, cause a pumping action to eject fluid through the cannula 4120. In aspects of the present disclosure, the above-described use of the ophthalmic device 4000 may be performed for any suitable reason unrelated to a medical procedure or treatment of a person, such as maintenance or testing of the ophthalmic device 4000. Thus, the ophthalmic device 4000 is not limited to medical treatment of humans, such as medical treatment of human eyes.

[0284] Thus, the activation assembly 4200 provides multiple functions of the ophthalmic device 4000 , such as advancing and / or retracting items (eg, guidewire 4140 , catheter 4150 , tensioning device 4180 ) through the cannula 4120 and pumping fluids through the cannula 4120 .

[0285] In some embodiments according to the present disclosure, an ophthalmic device includes: a shell; a cannula extending from the shell, the cannula having a lumen for fluid flow; a reservoir for holding the fluid; and an activation assembly, the activation assembly including: a rotatable wheel; and a movable shell ring connected to the wheel, wherein the rotatable wheel and the movable shell ring are configured to move inwardly toward the interior of the shell together when a first force is applied inwardly on the wheel, and to move outwardly away from the interior of the shell together when a second force is applied outwardly on one of the wheel and the movable shell ring.

[0286] In some aspects of the disclosure, the fixed housing ring is fixedly coupled to the housing and movably coupled to the movable housing ring, wherein the movable housing ring is configured to move inwardly and outwardly relative to the fixed housing ring. In some aspects of the disclosure, the housing includes a fixed housing ring coupled to the movable housing ring, wherein the movable housing ring is configured to move inwardly and outwardly relative to the fixed housing ring. In some aspects of the disclosure, the rotatable wheel is configured to move the catheter through the cannula. In some aspects of the disclosure, the rotatable wheel is configured to move the wire through the catheter. In some aspects of the disclosure, the rotatable wheel is configured to move the wire through the cannula. In some aspects of the disclosure, the rotatable wheel is configured to move the tensioner through the cannula. In some aspects of the disclosure, the rotatable wheel is configured to advance one of the catheter, wire, and tensioner when the rotatable wheel is rotated in a forward direction toward the cannula. In some aspects of the disclosure, the rotatable wheel is configured to retract one of the catheter, wire, and tensioner when the rotatable wheel is rotated in a backward direction away from the cannula.

[0287] In some aspects of the disclosure, the activation assembly is configured to pump fluid through the lumen of the cannula when the coupled rotatable wheel and the movable housing ring move inwardly. In some aspects of the disclosure, the activation assembly is configured to draw fluid from the fluid reservoir when the coupled rotatable wheel and the movable housing ring move outwardly. In some aspects of the disclosure, a spring is coupled to one of the rotatable wheel and the movable housing ring, wherein the spring is biased to provide a second force. In some aspects of the disclosure, the housing includes a tactile portion, the tactile portion being one of those formed with and disposed on the housing, the tactile portion being configured to provide an ergonomic grip.

[0288] In some aspects of the present disclosure, a catheter is configured to be slidably moved through a cannula, the catheter comprising an internal lumen for fluid flow. In some aspects of the present disclosure, a portion of the catheter comprises one or more side ports disposed in a wall of the catheter, the one or more side ports being configured to provide fluid flow from the internal lumen to the outside of the catheter. In some aspects of the present disclosure, the catheter comprises one or more O-rings disposed around the catheter, the one or more O-rings being configured to provide a restricted fluid zone outside the catheter. In some aspects of the present disclosure, the catheter comprises a bulb disposed at the end of the catheter, the bulb having a leading feature comprising one of a flat surface extending from the bulb and a tip portion extending from the bulb. In some aspects of the present disclosure, the catheter comprises a hole disposed at the end of the catheter, the hole being configured to provide one of: a fluid passage from the internal lumen; slidable movement of a suture disposed in the internal lumen; and slidable movement of a tensioning device disposed in the internal lumen. In some aspects of the present disclosure, a catheter includes an axial indentation disposed in an exterior surface of a catheter wall, the axial indentation configured to receive one of a suture and a tensioning device.

[0289] In some embodiments according to the present disclosure, a method of operating an ophthalmic device includes: grasping a housing of the ophthalmic device; applying a rotational force to a wheel of an activation assembly of the ophthalmic device; slidably moving one of a catheter, a wire, and a tensioning device through a cannula of the ophthalmic device based on the rotational force; applying an inward orthogonal force to the wheel; moving the wheel and a movable housing ring connected to the wheel inward toward the interior of the housing based on the inward orthogonal force; pumping fluid through a lumen of the cannula based on the inward movement of the connected wheel and movable housing ring; applying an outward orthogonal force to the connected wheel and movable housing ring; and extracting fluid from a reservoir based on the outward movement of the connected wheel and movable housing ring.

[0290] It should be understood that any specific order or hierarchy of blocks in the disclosed process methods is an illustration of an example method. Based on design or implementation preferences, it should be understood that the specific order or hierarchy of blocks in the process can be rearranged, or all of the blocks shown can be executed. In some embodiments, any block can be executed simultaneously.

[0291] The present disclosure is provided to enable those skilled in the art to practice the various aspects described herein. The present disclosure provides various examples of the subject technology, and the subject technology is not limited to these examples. Various modifications to these aspects will be apparent to those skilled in the art, and the general principles defined herein can be applied to other aspects.

[0292] Unless otherwise specified, reference to an element in the singular is not intended to mean "one and only one," but rather "one or more." Unless otherwise specified, the term "some" refers to one or more. Masculine pronouns (e.g., his) include feminine and neuter pronouns (e.g., her and its) and vice versa. Headings and subheadings, if any, are used for convenience only and do not limit the invention.

[0293] The word "exemplary" is used herein to mean "serving as an example or illustration." Any aspect or design described herein as "exemplary" is not necessarily to be construed as preferred or advantageous over other aspects or designs. In one aspect, the various alternative configurations and operations described herein may be considered to be at least equivalent.

[0294] As used herein, the phrase "at least one" preceding a list of items (with the term "or" separating any items) modifies the list as a whole rather than each item in the list. The phrase "at least one" does not require selection of at least one item; rather, the phrase allows for a meaning that includes at least one of any one of the items and / or at least one of any combination of the items and / or at least one of each of the items. For example, the phrase "at least one of A, B, or C" may mean: only A, only B, or only C; or any combination of A, B, C.

[0295] Phrases such as "an aspect" do not mean that such aspects are essential to the subject technology or that such aspects apply to all configurations of the subject technology. The disclosure related to an aspect may apply to all configurations or one or more configurations. An aspect may provide one or more examples. Phrases such as "an aspect" may refer to one or more aspects, and vice versa. Phrases such as "an embodiment" do not mean that such embodiments are essential to the subject technology or that such embodiments apply to all configurations of the subject technology. The disclosure related to an embodiment may apply to all embodiments or one or more embodiments. An embodiment may provide one or more examples. Phrases such as "an embodiment" may refer to one or more embodiments, and vice versa. Phrases such as "configuration" do not mean that such configurations are essential to the subject technology or that such configurations apply to all configurations of the subject technology. The disclosure related to a configuration may apply to all configurations or one or more configurations. A configuration may provide one or more examples. Phrases such as "a configuration" may refer to one or more configurations, and vice versa.

[0296] In one aspect, unless otherwise indicated, all measurements, values, ratings, positions, amplitudes, sizes, and other specifications set forth in this specification (including in the appended claims) are approximate and not exact. In one aspect, they are intended to have a reasonable range consistent with the functions to which they are related and with the customary practices in the art to which they belong.

[0297] It should be understood that the specific order or hierarchy of steps, operations or processes disclosed is an illustration of an exemplary method. Based on design preferences, it should be understood that the specific order or hierarchy of steps, operations or processes can be rearranged. Some steps, operations or processes can be performed simultaneously. Some or all of the steps, operations or processes can be performed automatically without user intervention. The attached method claims (if any) present the elements of the various steps, operations or processes in a sample order and are not meant to be limited to the specific order or hierarchy presented.

[0298] All structural and functional equivalents of the elements of the various aspects described throughout the present disclosure that are known or will be known to those of ordinary skill in the art are expressly incorporated herein by reference and are intended to be covered by the claims. In addition, regardless of whether such disclosure is explicitly recited in the claims, nothing disclosed herein is intended to be committed to the public. No claim element can be interpreted according to the provisions of 35 U.S.C. § 112 (f) unless the element is explicitly stated using the phrase "means for...", or in the case of a method claim, the element is stated using the phrase "for..." step. In addition, for the scope of the terms "including", "having", etc. used, such terms are intended to be inclusive in a manner similar to the term "comprising", as explained when "comprising" is used as a transitional word in the claims.

[0299] The title, background technology, content, description of the drawings and abstract of the present disclosure are hereby incorporated into the present disclosure and are provided as illustrative examples of the present disclosure, rather than restrictive descriptions. The submission of this application is based on the understanding that they will not be used to limit the scope or meaning of the claims. In addition, in the specific implementation, it can be seen that the specific implementation provides illustrative examples, and in order to simplify the present disclosure, various features are combined together in various embodiments. This method of the present disclosure should not be interpreted as reflecting the intention that the subject matter claimed for protection requires more features than those explicitly stated in each claim. On the contrary, as reflected in the attached claims, the subject matter of the invention lies in less than all the features of a single disclosed configuration or operation. The attached claims are thus incorporated into the specific implementation, and each claim is independently a subject matter claimed for protection.

[0300] The claims are not intended to be limited to the aspects described herein, but are to be accorded the full scope consistent with the language of the claims and including all legal equivalents. Nevertheless, all claims are not intended to include subject matter that fails to satisfy the requirements of 35 U.S.C. §101, 102, or 103, nor should they be interpreted in such a manner.

Claims

1. An ophthalmic device comprising: case; a cannula extending from the housing, the cannula having a lumen for fluid flow; a reservoir for containing a fluid; and Activation components, which include: Rotatable wheels; and A movable housing ring coupled to the wheel, wherein the rotatable wheel and the movable housing ring are configured to move inwardly together toward the interior of the housing when a first force is applied inwardly on the wheel, and to move outwardly together away from the interior of the housing when a second force is applied outwardly on one of the wheel and the movable housing ring.

2. The ophthalmic device of claim 1 , further comprising a fixed housing ring fixedly coupled to the housing and movably coupled to the movable housing ring, wherein The movable housing ring is configured to move inwardly and outwardly relative to the stationary housing ring.

3. The ophthalmic device according to claim 1, wherein: The housing includes a stationary housing ring coupled to the movable housing ring, wherein the movable housing ring is configured to move inwardly and outwardly relative to the stationary housing ring.

4. The ophthalmic device according to claim 1, wherein: The rotatable wheel is configured to move a catheter through the cannula.

5. The ophthalmic device according to claim 4, wherein: The rotatable wheel is configured to move a wire through the catheter.

6. The ophthalmic device according to claim 1, wherein: The rotatable wheel is configured to move a wire through the cannula.

7. The ophthalmic device according to claim 1, wherein: The rotatable wheel is configured to move the tensioning device through the cannula.

8. The ophthalmic device according to claim 1, wherein: The rotatable wheel is configured to advance one of a catheter, a wire, and a tensioning device when the rotatable wheel is rotated in a forward direction toward the cannula.

9. The ophthalmic device according to claim 1, wherein: The rotatable wheel is configured to retract one of a catheter, a wire, and a tensioning device when the rotatable wheel is rotated in a rearward direction away from the cannula.

10. The ophthalmic device according to claim 1, wherein: The activation assembly is configured to pump fluid through the lumen of the cannula when the coupled rotatable wheel and movable housing ring move inwardly.

11. The ophthalmic device according to claim 1, wherein: The activation assembly is configured to draw fluid from the fluid reservoir when the coupled rotatable wheel and movable housing ring move outwardly.

12. The ophthalmic device of claim 1 , further comprising a spring coupled to one of the rotatable wheel and the movable housing ring, wherein The spring is biased to provide the second force.

13. The ophthalmic device according to claim 1, wherein: The housing includes a tactile portion, the tactile portion being one of formed with and disposed on the housing, the tactile portion being configured to provide an ergonomic grip.

14. The ophthalmic device of claim 1, further comprising a catheter configured to slidably move through the cannula, the catheter comprising an internal lumen for fluid flow.

15. The ophthalmic device according to claim 14, wherein: A portion of the catheter includes one or more side ports disposed in a wall of the catheter, the one or more side ports configured to provide fluid flow from the interior lumen to an exterior of the catheter.

16. The ophthalmic device according to claim 15, wherein: The catheter includes one or more O-rings disposed about the catheter, the one or more O-rings configured to provide a confined fluid zone outside the catheter.

17. The ophthalmic device of claim 14, wherein: The catheter includes a bulb disposed at a distal end of the catheter, the bulb having a leading feature including one of a flat surface extending from the bulb and a tip portion extending from the bulb.

18. The ophthalmic device of claim 14, wherein: The catheter comprises an aperture disposed at a distal end of the catheter, the aperture being configured to provide one of: a fluid passage from said interior lumen; slidable movement of a suture disposed within the interior lumen; and Slidable movement of a tensioning device disposed within the interior lumen.

19. The ophthalmic device of claim 14, wherein: The catheter includes an axial indentation disposed in an exterior surface of a catheter wall, the axial indentation configured to receive one of a suture and a tensioning device.

20. A method of operating an ophthalmic device, the method comprising: grasping a housing of the ophthalmic device; applying a rotational force to a wheel of an activation component of the ophthalmic device; slidably moving one of a catheter, a wire, and a tensioning device through a cannula of the ophthalmic device based on the rotational force; applying an inward normal force to the wheel; moving the wheel together with a movable housing ring coupled to the wheel inwardly toward an interior of the housing based on the inward normal force; pumping fluid through the lumen of the cannula based on inward movement of the coupled wheel and movable housing ring; applying an outward normal force to the coupled wheel and movable housing ring; as well as Fluid is drawn from the reservoir upon outward movement of the coupled wheel and movable housing ring.

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