Ophthalmic Devices

Abstract

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

Description

[Technical field]

[0001] This application claims the benefit of priority to U.S. Provisional Patent Application No. 63 / 412,072, entitled "OPHTHALMIC DEVICE," filed on September 30, 2022, and U.S. Provisional Patent Application No. 63 / 322,904, entitled "OPHTHALMIC DEVICE," filed on March 23, 2022, the contents of each of which are incorporated by reference in their entirety herein.

[0002] The present disclosure relates generally to ophthalmic devices, and more particularly, to ophthalmic devices for delivering viscous fluids to the eye. [Background technology]

[0003] In ophthalmic surgery, highly viscous substances, often referred to as surgical viscoelastics, are injected into the eye as a surgical aid. Viscoelastics used in ophthalmic surgery include compounds containing hyaluronic acid, chondroitin sulfate, or chemically modified cellulose. Due to the unique shear thinning or thixotropic properties of such materials, viscoelastics can be injected through small bore needles or cannulas, which then recoil to the substance to provide stiff gel-like properties after injection. Viscoelastics are often injected into the anterior chamber of the eye during cataract surgery for the purposes of maintaining intraocular space and protecting the corneal endothelium from mechanical damage. Viscoelastic injections are utilized to expand tissue spaces, such as Schlemm's canal, during glaucoma surgery. Viscoelastic injections are also utilized to cut tissues, such as the lens capsule or retina. It is therefore desirable to provide an ophthalmic device for making intrusions into the eye and for injecting viscous fluids into the eye.

[0004] 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. [Brief description of the drawings]

[0005] [Figure 1] FIG. 1 is a front cross-sectional view of an ophthalmic device. [Diagram 2] FIG. 1 is a front cross-sectional view of an ophthalmic device. [Diagram 3] FIG. 1 is a front cross-sectional view of an ophthalmic device. [Figure 4] FIG. 1 is a front cross-sectional view of an ophthalmic device having a pressure gauge. [Diagram 5] 1 is a graph showing pressure versus flow rate for delivery of a viscoelastic material from an ophthalmic device. [Figure 6] FIG. 13 is a front cross-sectional view of a composite microcannula having a tapered reinforcing element. [Figure 7] FIG. 13 is a front cross-sectional view of a composite microcannula having two reinforcing elements, one full length and one partial length. [Figure 8] FIG. 1 shows a front partial cross-sectional view of a composite microcannula having a helically wound reinforcing element in the form of a round wire. [Figure 9] FIG. 1 shows a front partial cross-sectional view of a composite microcannula having a helically wound reinforcing element in the form of a flattened ribbon. [Figure 10] FIG. 13 is an enlarged perspective view of a curved composite microcannula having a signal transmitter tip that extends beyond the distal tip of the outer sheath. [Figure 11] FIG. 13 is a front cross-sectional view of a composite microcannula having a tapered reinforcing element and a rounded distal tip. [Figure 12] FIG. 1 is a front cross-sectional view of a composite microcannula having a ball-ended distal tip formed separately from the communication element and optical fiber to provide a transmitter using light scattering at the tip. [Figure 13] FIG. 1 is a stylized cross-sectional view showing some of the structures associated with the eye and the flow of aqueous humor out of the eye. [Figure 14] FIG. 1 is a perspective view showing an exemplary delivery system for implanting an ocular device. [Figure 15] FIG. 2 is a side view illustrating an exemplary cannula of the delivery system. [Figure 16A] FIG. 2 is a perspective view showing an example drive assembly in the handle of the system in a first orientation for use with one hand. [Figure 16B] FIG. 16B is a perspective view of FIG. 16A with the handle in an inverted second orientation that may be used with one hand. [Figure 17A] FIG. 13 is a perspective view of an exemplary engagement mechanism. [Figure 17B] FIG. 13 is a perspective view of an exemplary engagement mechanism. [Figure 18] FIG. 13 is a perspective view showing an engagement mechanism according to one modified embodiment. [Figure 19A] FIG. 13 is a perspective view showing an engagement mechanism according to another modified embodiment. [Figure 19B] FIG. 13 is a perspective view showing an engagement mechanism according to another modified embodiment. [Figure 20A] FIG. 13 is a perspective view showing an engagement mechanism according to a further modified embodiment. [Figure 20B] FIG. 13 is a perspective view showing an engagement mechanism according to a further modified embodiment. [Figure 21] FIG. 13 is a perspective view showing another exemplary engagement mechanism. [Figure 22A] FIG. 1 is a perspective view illustrating an exemplary delivery system for delivering a fluid composition into Schlemm's canal. [Figure 22B] FIG. 22B is a perspective, partially cross-sectional view of the delivery system of FIG. 22A. [Figure 23A] 1 illustrates an exemplary method of delivering a fluid composition out of a delivery system. [Figure 23B] 1 illustrates an exemplary method of delivering a fluid composition out of a delivery system. [Figure 23C] 1 illustrates an exemplary method of delivering a fluid composition out of a delivery system. [Figure 24] FIG. 1 illustrates an exemplary slidable conduit for delivering a fluid composition. [Figure 25A] FIG. 13 is a side view of a slidable conduit according to another variation. [Figure 25B] FIG. 13 is a side view of a slidable conduit according to another variation. [Figure 25C] FIG. 13 is a perspective view showing a slidable conduit according to another variation. [Figure 26] FIG. 2 is a stylized diagram showing an ab-interno technique for accessing Schlemm's canal with the cannula of an exemplary delivery system. [Figure 27] 13A-13C show an exemplary cannula according to another variation. [Figure 28] 1 is a stylized diagram showing the ab interno technique of accessing Schlemm's canal from a single point and delivering a viscoelastic fluid while advancing a fluid delivery conduit along a 360 degree arc of Schlemm's canal. [Figure 29] FIG. 1 is a stylized diagram showing the ab interno technique of accessing Schlemm's canal from a single point and delivering a viscoelastic fluid while advancing a fluid delivery conduit in both clockwise and counterclockwise directions along a 180 degree arc of Schlemm's canal. [Figure 30A] 1A-1C show an exemplary ab interno method of cutting or tearing the trabecular meshwork. [Figure 30B] 1A-1C show an exemplary ab interno method of cutting or tearing the trabecular meshwork. [Figure 30C] 1A-1C show an exemplary ab interno method of cutting or tearing the trabecular meshwork. [Figure 31A] FIG. 1 is a top view of an embodiment of a cannula adapter in an undeployed configuration. [Figure 31B] FIG. 1 is a top view of an embodiment of a cannula adapter in a fully deployed configuration. [Figure 31C] FIG. 31B illustrates an example of how the cannula adapter of FIG. 31A can be attached to a standard ophthalmic viscosurgical device, such as an ophthalmic viscoelastic syringe. [Figure 31D]FIG. 31B illustrates an example of how the cannula adapter of FIG. 31A can be attached to a standard ophthalmic viscosurgical device, such as an ophthalmic viscoelastic syringe. [Figure 31E] FIG. 31B illustrates an example of surgical implantation of the cannula adapter of FIG. 31A and its access and insertion. [Fig. 31F] FIG. 31B shows an example of surgical implantation of the cannula adapter of FIG. 31A and its access and insertion. [Figure 31G] 31B shows another example of surgical implantation of the cannula adapter of FIG. 31A for access and insertion. FIG. [Fig. 31H] 31B shows another example of surgical implantation of the cannula adapter of FIG. 31A for access and insertion. FIG. [Fig. 31I] FIG. 31C is a top view showing a system including the cannula adapter of FIG. 31A in combination with an additional adapter coupled to the proximal end of a standard ophthalmic viscosurgical device of FIG. 31C to assist in controlled fluid delivery. [Figure 32A] FIG. 13 is a side view of another embodiment of a cannula adapter having a sliding trigger in an undeployed configuration. [Figure 32B] FIG. 13 is a side view of another embodiment of a cannula adapter having a sliding trigger in a fully deployed configuration. [Figure 32C] FIG. 32B is a side view showing adaptation of the embodiment of FIG. 32A including a coupler to assist pneumatic fluid delivery. [Fig. 32D] FIG. 32D illustrates an exemplary embodiment of a pneumatic system adapted for use with the cannula adapter of FIG. 32C. [Figure 32E] FIG. 32D illustrates an exemplary embodiment of a pneumatic system adapted to be used with the cannula adapter of FIG. 32C. [Figure 33A] FIG. 13 illustrates another embodiment of a cannula adapter that utilizes a compression spring to maintain the force applied to the ophthalmic viscosurgical device. [Figure 33B] 33B shows an exemplary operation scheme of the cannula adapter of FIG. 33A. [Figure 33C] 33B shows an exemplary operation scheme of the cannula adapter of FIG. 33A. [Figure 33D] 33B shows an exemplary operation scheme of the cannula adapter of FIG. 33A. [Figure 34A] FIG. 13 illustrates a three-layer assembly that may be incorporated into any of the cannula adapter embodiments. [Figure 34B] FIG. 13 illustrates a three-layer assembly that may be incorporated into any of the cannula adapter embodiments. [Figure 34C] FIG. 13 illustrates a three-layer assembly that may be incorporated into any of the cannula adapter embodiments. [Fig. 34D] FIG. 34D is an enlarged side view of the distal tip of the three-layer assembly of FIG. 34C. [Figure 34E] FIG. 34A illustrates an exemplary operation scheme for the three-layer assembly of FIGS. 34A-34C. [Fig. 34F] FIG. 34A illustrates an exemplary operation scheme for the three-layer assembly of FIGS. 34A-34C. [Figure 34G] FIG. 34A illustrates an exemplary operation scheme for the three-layer assembly of FIGS. 34A-34C. [Figure 35A] 13A-13C illustrate various embodiments of internal support mechanisms that may be incorporated into any of the cannula adapter embodiments. [Figure 35B] 13A-13C illustrate various embodiments of internal support mechanisms that may be incorporated into any of the cannula adapter embodiments. [Figure 36A] 13A-13C illustrate various embodiments of internal support mechanisms that may be incorporated into any of the cannula adapter embodiments. [Figure 36B] 13A-13C illustrate various embodiments of internal support mechanisms that may be incorporated into any of the cannula adapter embodiments. [Figure 37A] 13A-13C illustrate various embodiments of internal support mechanisms that may be incorporated into any of the cannula adapter embodiments. [Figure 37B]13A-13C illustrate various embodiments of internal support mechanisms that may be incorporated into any of the cannula adapter embodiments. [Figure 38A] 13A-13C illustrate various embodiments of internal support mechanisms that may be incorporated into any of the cannula adapter embodiments. [Figure 38B] 13A-13C illustrate various embodiments of internal support mechanisms that may be incorporated into any of the cannula adapter embodiments. [Figure 39A] FIG. 13 is an external top view of an embodiment of a cannula adapter having a dial feed system illustrating an exemplary operation scheme of the cannula adapter. [Figure 39B] FIG. 13 is an external top view of an embodiment of a cannula adapter having a dial feed system illustrating an exemplary operation scheme of the cannula adapter. [Figure 39C] FIG. 39B is an internal top view showing an exemplary operation scheme of the cannula adapter of FIG. [Figure 39D] FIG. 39B is an internal top view showing an exemplary operation scheme of the cannula adapter of FIG. [Figure 39E] FIG. 9B is a side view showing an exemplary operation scheme of the cannula adapter of FIG. 9A. [Figure 39F] FIG. 9B is a side view showing an exemplary operation scheme of the cannula adapter of FIG. 9A. [Figure 40A] FIG. 13 illustrates an exemplary operation scheme of a cannula adapter having a spring actuation system with a fillable reservoir. [Figure 40B] FIG. 13 illustrates an exemplary operation scheme of a cannula adapter having a spring actuation system with a fillable reservoir. [Figure 40C] FIG. 13 illustrates an exemplary operation scheme of a cannula adapter having a spring actuation system with a fillable reservoir. [Figure 41A]FIG. 13 illustrates an exemplary operation scheme of a fillable cannula adapter having a threaded plunger fluid delivery system with reflux. [Figure 41B] FIG. 13 illustrates an exemplary operation scheme of a fillable cannula adapter having a threaded plunger fluid delivery system with reflux. [Figure 42A] FIG. 13 illustrates an exemplary operation scheme of an embodiment of a filled elastic tube fluid delivery mechanism. [Figure 42B] FIG. 13 illustrates an exemplary operation scheme of an embodiment of a filled elastic tube fluid delivery mechanism. [Figure 43A] FIG. 1 illustrates an example of a peristaltic fluid delivery mechanism. [Figure 43B] FIG. 1 illustrates an example of a peristaltic fluid delivery mechanism. [Figure 43C] FIG. 1 illustrates an example of a peristaltic fluid delivery mechanism. [Diagram 44] 13A-13C show various examples of inner catheter shapes and structures to facilitate visualization that may be incorporated into any of the cannula adapter embodiments. [Figure 45A] 13A-13D illustrate an exemplary operation of a shape set cannula that may be incorporated into any of the cannula adapter embodiments. [Figure 45B] 13A-13C illustrate an exemplary operation of a shape-fixed cannula that may be incorporated into any of the cannula adapter embodiments. [Figure 46] FIG. 13 shows an embodiment of a cannula having a notched distal tip to facilitate articulation that may be incorporated into any of the cannula adapter embodiments. [Figure 47A] FIG. 13 is a perspective view of another embodiment of a cannula adapter or fluid delivery device. [Figure 47B] FIG. 47B is an exploded perspective view showing the cannula adapter of FIG. 47A. [Figure 47C] FIG. 47B is a cross-sectional view showing the cannula adapter of FIG. 47A. [Figure 47D]FIG. 47B is a cross-sectional view showing the cannula adapter of FIG. 47A. [Figure 47E] FIG. 47D is an enlarged cross-sectional view of the cannula adapter of FIG. 47A. [Fig.47F] FIG. 47B is an enlarged cross-sectional view showing the tip of the cannula adapter of FIG. 47A. [Figure 47G] FIG. 47B is a cross-sectional view of the cannula adapter of FIG. 47A without the locking pin. [Fig. 47H] FIG. 47H is a cross-sectional view showing the cannula adapter of FIG. 47G. [Figure 48A] FIG. 13 illustrates an outer cannula that may be incorporated into any of the cannula adapter embodiments. [Figure 48B] FIG. 13 illustrates an outer cannula that may be incorporated into any of the cannula adapter embodiments. [Figure 48C] FIG. 13 illustrates an inner catheter that may be incorporated into any of the cannula adapter embodiments. [Figure 48D] FIG. 13 illustrates an inner catheter that may be incorporated into any of the cannula adapter embodiments. [Figure 48E] 1A-1C show examples of the distal tip of a cannula of a fluid delivery device. [Fig.48F] 1A-1C show examples of the distal tip of a cannula of a fluid delivery device. [Figure 48G] 1A-1C show examples of the distal tip of a cannula of a fluid delivery device. [Fig. 48H] 1A-1C show examples of the distal tip of a cannula of a fluid delivery device. [Figure 49A] 13A-13C illustrate an exemplary operation scheme of another embodiment of the cannula adapter. [Figure 49B] 13A-13C illustrate an exemplary operation scheme of another embodiment of the cannula adapter. [Figure 50] FIG. 1 shows a schematic illustration of a tip portion of an ophthalmic device. [Figure 51]1A-1C show schematic illustrations of fluid flow from the tip of an ophthalmic device with and without a barrier. [Figure 52] 1A-1D show schematic illustrations of various tips of ophthalmic devices. [Diagram 53] FIG. 1 shows a schematic illustration of a catheter having a fluid distribution orifice and having a suture disposed within the catheter. [Figure 54] FIG. 1 shows a schematic illustration of a catheter having sutures disposed on an outer portion of the catheter. [Figure 55] FIG. 1 shows a schematic illustration of a suture ball joined to a suture ring to form a suture loop. [Figure 56] FIG. 1 shows a schematic illustration of a suture structure. [Figure 57] FIG. 1 shows a schematic illustration of a suture structure. [Figure 58A] 13A-13C illustrate steps for placing a guidewire and tension suture in the eye. [Figure 58B] 13A-13C illustrate steps for placing a guidewire and tension suture in the eye. [Figure 58C] 13A-13C illustrate steps for placing a guidewire and tension suture in the eye. [Fig. 58D] 13A-13C illustrate steps for placing a guidewire and tension suture in the eye. [Figure 59] FIG. 13 shows a push wire being deployed from a catheter. [Figure 60A] FIG. 1 is a front cross-sectional view showing a tension device disposed within Schlemm's canal. [Figure 60B] FIG. 1 is a perspective cross-sectional view showing a tension device disposed within Schlemm's canal. [Figure 61] FIG. 1 illustrates a tensioning device. [Figure 62A] FIG. 1 illustrates a tensioning device at various contraction levels. [Figure 62B] FIG. 1 illustrates a tensioning device at various contraction levels. [Figure 62A] FIG. 1 illustrates a tensioning device at various contraction levels. [Figure 63A] 13A-13C show another tensioning device at various contraction levels. [Figure 63B] 13A-13C show another tensioning device at various contraction levels. [Figure 63C] 13A-13C show another tensioning device at various contraction levels. [Figure 64] FIG. 1 is a perspective view of an ophthalmic device. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0006] The detailed description set forth below describes various configurations of the technology of the present subject matter, and is not intended to represent the only configurations in which the technology of the present subject matter can be implemented. The detailed description includes specific details for the purpose of achieving a thorough understanding of the technology of the present subject matter. Thus, dimensions in certain respects are provided as non-limiting examples. However, it will be apparent to those skilled in the art that the technology of the present subject matter can be implemented without these specific details. In some instances, well-known structures and components are shown in block diagram form to avoid obscuring the concepts of the technology of the present subject matter.

[0007] It will 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 are disclosed herein according to specific, but non-limiting examples. Various embodiments described in the present disclosure can be implemented in a variety of ways and variations according to a desired application or implementation.

[0008] The ophthalmic device of the present disclosure comprises a syringe body having a proximal end and an opposing distal end with a hollow bore between the ends. A plunger is disposed within the hollow bore and is coupled to a mechanism that provides positive displacement of the plunger upon actuation. The positive displacement mechanism allows for high precision in the delivery of viscous, and specifically viscoelastic, materials from the syringe body from the distal end. "Positive displacement" means that a force is applied to the plunger and / or linear translation of the plunger is progressively restricted to provide a constant or precisely incremental, controllable delivery of material from the distal end of the syringe body. The positive displacement mechanism may be configured to allow forward linear translation of the plunger in discrete increments to control the delivery. The syringe body has a fluid outlet at the distal end that may terminate in a connector, such as a Luer fitting, for attachment of a needle or cannula.

[0009] Referring to FIG. 1, in one embodiment of an ophthalmic device 3, a threaded rod 1 is attached at its distal end to a plunger 6. The plunger 6 is located within a syringe body 4 having a proximal flange 8. A cap 5 is connected to the flange 8. At the proximal end of the rod 1 is a handle 2 that can function as a thumbwheel to turn the rod to advance the plunger 6. A stop 7 is located within the syringe body 4 to form an airtight seal when the force of the advancing plunger is applied against the viscous material within the syringe body. The viscous material is expelled through the distal end of the syringe body into a suitable receiving device.

[0010] In another embodiment of the ophthalmic device 10, referring to FIG. 2, a cartridge 12 pre-filled with a viscoelastic material with a rubber septum 22 at its distal end may be loaded into a syringe body 11 and injected in a controlled manner using a screw mechanism with a threaded rod 18 attached to a distal plunger assembly 16 with a plunger 19, thrust bushing 20, and rubber stop 23 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 may have a seal, such as an O-ring or 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 orifice in the cap assembly 15 at the proximal end of the syringe body 11. Turning the end of the rod 18 advances the plunger 19, thereby expelling the viscous material loaded within the cartridge 12. The cap 15 can be removed to insert the pre-filled cartridge 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 for penetrating into the cartridge. The needle provides a flow path from the cartridge to a male luer fitting 14 on the distal end of the ophthalmic device. A rubber septum 22 provides a fluid-tight seal of the cartridge against the internal needle. An internal thrust bushing 20 and a rubber stop 23 at the end of the plunger assembly 16 interface with the proximal end of the cartridge 12. When the ophthalmic device handle 21 is turned, the threaded rod 18 acts against the plunger assembly 16, thereby providing a positive displacement action against the cartridge to deliver the cartridge contents through the distal luer fitting 14.

[0011] By using a positive displacement mechanism, the absence of compressible components ensures accurate and repeatable delivery characteristics. Ophthalmic devices according to the present disclosure precisely deliver small increments (microvolumes) of viscous fluid, typically in the range of 5 to 25 microliters. The subject technology is particularly advantageous because delivering small amounts of viscous fluid is difficult when attempting to deliver through small bore needles, microcannulas, or microcatheters. Precise delivery of small amounts of viscous fluid is particularly important in microsurgery, where fluids are used to dilate or cut delicate tissue structures.

[0012] 3, in another embodiment, the positive displacement mechanism comprises a threaded rod 40 that attaches a syringe body plate 41 to a plunger plate 44 that is parallel to it. Turning the rod 40 moves the plates 41 and 44 towards or away from each other. Plate 41 is attached to the syringe body 42 and plate 44 is attached to the plunger shaft 43 such that the plunger is moved to allow precise control of the delivery of material from the syringe body.

[0013] In another embodiment, the positive displacement mechanism comprises a plunger having a series of spaced apart mechanical stops with a predetermined spacing arranged to allow linear advancement of the plunger from one mechanical stop to the next. A release mechanism or additional advancement force may be utilized to continue to advance the plunger to the next stop. The amount of plunger translation allowed by each stop may be adjusted to set the precision of ocular device delivery.

[0014] In another embodiment, the positive displacement mechanism is attached to a conventional syringe body, thereby allowing the positive displacement mechanism to be used with a variety of packaged viscoelastic syringe kits. For example, the mechanism may be attached to a syringe flange and may act against or replace a provided plunger. Additionally, in one feature, the ophthalmic device may be provided as a kit including the ophthalmic device, one or more microcannulas for delivering a substance from the ophthalmic device to a surgical site, and / or a packaged cartridge containing a viscoelastic substance that is useful in surgical or medical applications.

[0015] Ophthalmic devices may be made from any suitable high strength material, such as metals and polymers. Materials that can be sterilized by conventional means, such as autoclaving, ethylene oxide gas treatment, or exposure to ionizing radiation, are suitable. Suitable materials include metals, such as steel and titanium, and polymers, such as polysulfone, polyethylene, nylon, polymethylmethacrylate, polyethylene terephthalate, polypropylene, and polycarbonate.

[0016] The ophthalmic device may also be used for flow control delivery, which aims to precisely deliver viscous fluids at low, predetermined flow rates by maintaining a predetermined variable or constant injection pressure. When injection is performed through a small bore device such as a microcannula or microcatheter with a controlled injection pressure, a constant or predetermined profile flow rate of the viscous fluid results. By managing the injection pressure, measured at the ejection section of the ophthalmic device or within the ophthalmic device, the flow rate can be controlled. With reference to FIG. 4, pressure management may be achieved by attaching a pressure gauge 36 or transducer to the ophthalmic device 35. A constant injection pressure may be maintained by manually controlling the positive displacement mechanism while monitoring the injection pressure, or alternatively by providing electrical feedback to the motorized actuator driving the injection mechanism. In an alternative embodiment, pressure management may also be achieved by mechanical means by limiting the force applied by the positive displacement mechanism. For example, a clutch mechanism may be integrated into the screw drive mechanism to limit the maximum force applied to deliver the viscous material.

[0017] The ophthalmic device may further incorporate a pressure relief valve to prevent over pressurization or pressure spikes during delivery of the viscous fluid. The pressure relief valve may consist of a ball-spring assembly, where the force of the spring presses a ball across an orifice until the injection pressure overcomes the force of the spring, thereby allowing fluid flow and pressure relief. The relief valve may be designed to allow the user to adjust the maximum injection pressure.

[0018] The present disclosure comprises a microcannula designed to be advanced into very small tissue spaces during surgery. In particular for ophthalmic surgery, the microcannula may be used to cannulate Schlemm's canal, the aqueous humor collector channel, the aqueous humor veins, the retinal veins, and the suprachoroidal space. Such structures range in diameter from 50 microns to 250 microns, thus limiting the outer diameter of the microcannula to comparable dimensions. The microcannula comprises a flexible elongated element having a connector at the proximal end 53, a distal tip, and a communication channel 51 therebetween, as can be seen in FIG. 6. The microcannula communication channel 51 may be used to deliver fluids, substances, energy, gases, suction, surgical tools, and implants to the distal surgical site for a variety of surgical tasks. The communication channel 51 may be the lumen of a tubular elongated element for transporting substances, an optical fiber for transporting light energy, or a wire for transporting electrical signals. A flexible elongated element having a communication channel 51 is referred to as a communication element. A single communication element may have two or more communication channels.

[0019] The microcannula of the present disclosure incorporates unique design features that allow for the placement of the microcannula in very small tissue spaces. A key feature is the use of a composite microcannula design that has an appropriate combination of axial stiffness and elastic compliance. The microcannula is desirably flexible to allow it to be advanced along curved or intricate tissue spaces, with sufficient axial stiffness or "pushability" to minimize tissue damage, but allow for the transmission of forces to advance the microcannula. If the outer dimensions are fixed, the mechanical properties of the microcannula can be tailored by the selection of the material and cross-sectional dimensions of the construct. In one embodiment, a reinforcing element 52 is attached to the outer portion of the communicating element. Typically, the reinforcing element 52 comprises a material that has a higher flexural modulus than the communicating element. The communicating element can be a thin-walled polymer or metal tube. The reinforcing element 52 may be formed from any high modulus material, such as metals, including, but not limited to, stainless steel and nickel-titanium alloys, ceramic fibers and high modulus polymers, filled polymers and reinforced polymers, and polymer-polymer composite materials.

[0020] For optimal use in small tissue spaces, it is desirable for the microcannula to transition to stiffer mechanical properties toward the proximal end but be flexible at the distal tip. This transition can include one or more steps in mechanical elastic compliance or can include a gradient in elastic compliance along the length of the microcannula. This gradient in mechanical properties can be achieved by a change in the cross-sectional area or mechanical properties of the microcannula along its length, the incorporation of one or more reinforcing members, or a combination thereof. In one embodiment of the present disclosure, the microcannula incorporates a communication element 51 made of a flexible polymer that forms a communication channel 51, where two reinforcing members 54, 55 are attached along its length, as can be seen in FIG. 7. One of the reinforcing members, 55, extends along the communication element but does not extend completely to the distal tip, whereas the other reinforcing member 54 extends completely to the distal tip, thereby providing a transition in bending elastic compliance. The reinforcing members 54, 55 may be formed of a high modulus polymer or metal. In a similar embodiment, a single reinforcing member having a transition in bending stiffness, such as tapered wire 52, may be used to reinforce the communication element. Alternatively, the reinforcing member may be formed of a series of segments of varying modulus or cross-sectional dimensions. The reinforcing elements may be held in place by an outer sheath 56, which may comprise a tight-fitting polymer tube or polymer shrink tubing. Alternatively, the reinforcing element may be attached or bonded to the communication element or may be completely or partially contained within the communication element.

[0021] The reinforcing element can also provide kink resistance to the communicating element. This is particularly advantageous for use with communicating elements made from high modulus polymers such as polyimide, polysulfone, ultra-high molecular weight polyethylene, and fiber reinforced polymer composites, which may twist or deform under high loads to form permanent mechanical defects. The reinforcing element can further include a malleable material to allow for manual adjustment of the shape of the microcannula to better accommodate the curved shape of the tissue space. Potential malleable materials for the reinforcing element include, but are not limited to, steel, silver, and platinum alloys.

[0022] Reinforcement of the communication element may also be achieved by incorporating coil-like elements that provide high bending compliance but also high axial stiffness for pushability, as can be seen in Figures 8 and 9. The reinforcing elements 57, 58 attached to the outer sheath may be coiled or wound elements or may be formed into the outer surface of the sheath. The reinforcing elements 57, 58 may be any suitable high modulus material, including, but not limited to, metals such as stainless steel, titanium and superelastic alloys, ceramics such as ceramic fiber, and high modulus polymers or mixed polymer structures such as carbon fiber reinforced epoxy. These elements may have any suitable cross-section, such as circular or semicircular or rectangular, as in the case of flat wire windings. The winding pitch of the reinforcing elements may be constant or may vary to achieve differential bending properties along the length of the microcannula. Multiple wound elements may be incorporated, where the elements are formed of similar or different materials. The reinforcing element or elements may also be configured to achieve a preferred deflection direction of the microcannula.

[0023] The composite microcannula of the present disclosure may further include multiple communication elements. In one embodiment, the microcannula may include two or more elongated communication elements with reinforcing members to form a composite structure. These components may be attached together and placed within an outer sheath such as heat shrink tubing, or the outer communication element may house one or more other communication elements. One of the communication elements may be used for the transfer of a substance and another of the communication elements may be used for the transfer of light or energy, thereby providing a multi-function surgical tool. The communication elements may be aligned side-by-side or may be arranged around one or more other communication elements. In one embodiment, a second communication element is provided for one communication element having an annular cross-section that forms a lumen, and the second communication element resides within the lumen. Such concentric alignment of communication elements may also be used in combination with other communication elements that are not in concentric alignment.

[0024] In one particular embodiment, the composite microcannula may be used solely to transfer mechanical energy. For example, the microcannula may be used to advance into a tissue space and retrieve a foreign body or tissue region. In such a case, the elongate communicating element may be a material such as a wire, polymer, or fiber composite of suitable mechanical properties. An inner member may further be incorporated that fits into and slides within the communicating element, the inner member having at least a proximal end and a distal tip. Advancement and retraction of the inner member may be utilized to change the shape of the distal tip of the microcannula or alternatively perform a mechanical action at the distal tip.

[0025] In one embodiment, the microcannula further comprises a proximal connector for the communicating element. The connector can function to connect a source of material or energy, such as an injection syringe or a light source, to the communicating channel 51 of the communicating element. In addition, the microcannula can include a central section with single or multiple side connectors to allow for the attachment of auxiliary equipment, such as syringes, vacuum or pressure sources, and sensing means. These attachment connectors can utilize standard designs, such as Luer fittings, or can be designed to only accept connections with specific components. In another embodiment, the composite microcannula can incorporate fenestrations or windows along its length. The fenestrations can be used to deliver substances from the sides of the microcannula, for example, to deliver therapeutic agents to the tissue of Schlemm's canal. Alternatively, if a vacuum generating device is connected to the proximal connector of the communicating element, the fenestrations can also be used to provide suction to the soft tissue. Suction can be used to remove tissue or to anchor the microcannula in place while another element is advanced through the microcannula, for example, a combined suction microcannula can be used to strip juxtacanalicular tissue from the inner wall of Schlemm's canal.

[0026] The communicating element may be formed of a thin-walled polymeric or metallic tube that is stiff enough to allow advancement into tissue or along a tissue space such as Schlemm's Canal, and flexible enough to move along the circular path of Schlemm's Canal. Due to the small size of the target tissue space, the microcannula must be sized appropriately. Typically, microcannulas are sized within the range of 50 to 350 microns outer diameter and have a wall thickness of 10-100 microns. The cross section of the microcannula may be circular or elliptical or other constraining shape to approximate the shape of a tissue space such as Schlemm's Canal. In some embodiments, a predetermined curvature may be applied to the device during fabrication.

[0027] 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 further have a surface treatment, such as a lubricious coating to aid in tissue penetration, or an ultrasonically or light-interactive coating to aid in localization and guidance. The microcannula may further have markings on the exterior portion to assess the depth of the tissue space. For example, the markings may take the form of rings around the outer shaft located at regular intervals along the length of the microcannula. The exterior markings allow the user to assess the length of the tissue space or channel accessed by the microcannula and to generally identify the location of the microcannula tip.

[0028] In an embodiment of the present disclosure, the first communicating element used to initially position the microcannula has a signaling emitter to identify the location of the microcannula distal tip relative to the target tissue, as can be seen in FIG. 10. The signaling means may include an echogenic material for ultrasonic guidance, an optically active material for optical guidance, or a light source for visual guidance located at the microcannula tip or positioned to indicate the location of the microcannula tip. In one embodiment, a plastic optical fiber (POF) 59 is used as the communicating element to provide a bright visual light source at the distal tip 60. The distal tip 60 of the POF 59 is located proximal to the distal end of the microcannula sheath, near the distal end of the microcannula sheath, or slightly beyond the distal end of the microcannula sheath, and the emitted signal may be detected visually through the tissue or using a sensing means such as infrared imaging. The POF 59 may further have a tip that is beveled, mirrored, or otherwise configured to provide a directional beacon. The transmitter may be illuminated by an incandescent light source such as a laser, laser diode, light emitting diode, or mercury halogen lamp. In alternative embodiments, the signaling means may include visualization aids along the length of the microcannula, for example, discrete lengths of side-emitting optical fiber leading to the distal tip or at known points along the microcannula may be used to indicate the location of the microcannula and distal tip. Once the microcannula is positioned at the target tissue, the transmitter assembly 61 and POF 59 may be removed. The connection point may be sealed with a cap or with a self-sealing mechanism such as a one-way valve or an elastomeric seal. Alternatively, the POF may be positioned collinear with or within the lumen of the delivery communication channel, thereby allowing fluid or gas to be delivered through the delivery communication channel without the need to remove the transmitter assembly.

[0029] Alternative embodiments of the microcannula may use other imaging techniques to identify the location of the signal emitter. 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 that are compatible with the imaging technique, such as a radiopaque marker attached or embedded at or near the distal tip of the microcannula. Alternatively or additionally, an echogenic material or coating or the like may be added to the distal tip.

[0030] As can be seen in Figures 11 and 12, it is also preferred that the microcannula have a rounded distal tip 62 to minimize tissue damage and to aid in the ability of the microcannula to advance into small tissue spaces. The rounded tip 62 can be of equal outer diameter to the microcannula or of a larger outer diameter than the microcannula depending on the specific characteristics desired. The rounded tip 62 can be formed and attached to the microcannula during assembly or, alternatively, the microcannula tip can be processed by a secondary operation to form a rounded contour. When the rounded tip 62 is used in conjunction with a light emitting signaling emitter 59 resulting in light being delivered proximal to the rounded tip, the tip functions to scatter the light 63. The scattered light aids visualization when viewing the microcannula off-axis, for example, when advancing the microcannula into Schlemm's canal.

[0031] Another important feature of the present disclosure is the use of a communication element to deliver fluid to the distal tip during advancement of the microcannula within the tissue space. Injection of a small amount of fluid can serve to open the tissue space ahead of the microcannula tip and lubricate the channel to greatly improve the ability to advance the microcannula atraumatically. Delivery of surgical viscoelastics such as hyaluronic acid solutions and gels is particularly effective in aiding in the advancement and placement of the microcannula. Delivery of fluids, particularly gel-like viscoelastics, can expand the tissue space in situations where a stenosis or partial occlusion is reached during advancement of the microcannula. A particularly effective embodiment includes a microcannula having a communication element such as an optical fiber to provide a signaling emitter at the microcannula tip and a second communication element to deliver a fluid such as a solution of hyaluronic acid to the microcannula tip while the signaling emitter is active. Such microcannulas can be manually manipulated and used to deliver fluids to aid in the advancement of the microcannula while simultaneously monitoring the position of the microcannula tip along the tissue space. The combination of fluid delivery within the microcannula pathway and monitoring the microcannula tip as it is advanced, retracted, and twisted allows for precisely controlled manipulation and advancement within tight tissue spaces. Ease of manipulation is further aided by the addition of reinforcing members to the microcannula's communicating elements.

[0032] Described herein are systems and methods for accessing Schlemm's canal and for delivering ocular devices and / or fluid compositions therein for the purpose of reducing intraocular pressure and thereby treating ocular conditions. Fluids and certain components of the system, such as slidable conduits, can be used to provide a force to disrupt trabeculocanalicular tissue, including the trabeculocanalicular meshwork, juxtacanalicular tissue, Schlemm's canal, and return channels. The term "disruption" as used herein refers to the delivery of a volume of fluid and system components that alters tissue in a manner that improves flow through the outflow pathways of the trabeculocanalicular meshwork. Examples of tissue disruption include, but are not limited to, dilating Schlemm's canal, dilating return channels, increasing the porosity of the trabeculocanalicular meshwork, stretching the trabeculocanalicular meshwork, creating very small tears in the juxtacanalicular tissue, removing septa from Schlemm's canal, cutting or removing trabeculocanalicular tissue, or combinations thereof.

[0033] To better understand the systems and methods described herein, it may be useful to explain some of the basic eye anatomy. FIG. 13 is a stylized depiction of a normal human eye 115. The anterior chamber 100 is shown bounded at its anterior face by the cornea 102. The cornea 102 is connected at its periphery to the sclera 104, a tough fibrous tissue that forms the white shell of the eye 115. A trabecular meshwork 106 is located at the outer edge 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 outer peripheral surface of the trabecular meshwork 106. Schlemm's canal 108 extends 360 degrees circumferentially around the trabecular meshwork 106. An angle 112 exists at the apex formed between the iris 110, the trabecular meshwork 106, and the sclera 104.

[0034] The system is generally configured for one-handed operation and control by a single operator and includes one or more features that are useful for easily accessing Schlemm's canal while minimizing damage. Once access to Schlemm's canal is achieved, the system can deliver an ocular device, a fluid composition, or both. In some variations, the system advances a tool that divides 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 within and extendable from a cannula used to access Schlemm's canal, the conduit having an outer diameter sized to divide Schlemm's canal and surrounding tissue. The distal end of the conduit can be further equipped with a dividing component to assist in dividing the trabecular meshwork canalicular tissue.

[0035] The device implanted into Schlemm's canal will generally be configured to maintain the patency of Schlemm's canal without substantially interfering with transmural fluid flow across Schlemm's canal. An ocular implant may be delivered. In some variations, the implant includes a support having at least one fenestration that spans Schlemm's canal or completely traverses the central core of Schlemm's canal without substantially interfering with transmural or longitudinal fluid flow along Schlemm's canal. The ocular device may further disrupt the juxtacanalicular trabecular meshwork or the adjacent inner wall of Schlemm's canal. The ocular device may further be coated with a drug that is useful for treating ocular hypertension, glaucoma or early glaucoma, infection, or post-operative wounds or inflammation. The ocular device may further be formed to be solid, semi-solid, or bioabsorbable.

[0036] The system may further be used to deliver a fluid composition, such as saline or a viscoelastic fluid. Saline may be used for irrigation. Viscoelastic fluid may be employed in an ab interno version of a viscocanalostomy or canaloplasty procedure to disrupt Schlemm's canal and surrounding tissue.

[0037] The systems described herein can be one-handed, single-operator controlled devices that typically include a universal handle having a gripping portion and a housing having an inner portion and a distal end. A cannula is typically coupled to and extends from the distal end of the housing. The cannula can include a proximal end and a distal curved portion, where the distal curved portion has a proximal end and a distal end and has a radius of curvature defined between the ends. The cannula can be further configured to include a body; a distal tip having a beveled surface; and a lumen extending from the proximal end through the distal tip. The beveled surface can directly engage the distal end of the curved portion of the cannula (i.e., the beveled surface can directly engage the radius of curvature). The systems can generally include a drive assembly partially contained within the housing that includes gears that convert rotational motion to linear motion. If 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, disposed coaxially within the cannula lumen. The system may further be configured to include a fluid assembly in the handle and a slidable conduit, disposed coaxially within the cannula lumen, if a fluid composition is to be delivered into Schlemm's canal. Fluid compositions such as saline, viscoelastic fluids including viscoelastic solutions, air, and gas may be delivered using the system. Appropriate markings, coloring, or indicators may be included on any part of the system to assist in identifying the location or position of the distal end of the cannula, the positioning element, the engagement mechanism, the ocular device, or the slidable conduit.

[0038] The ocular delivery system described herein can include a universal handle that allows for one-handed use. For example, the handle can be configured to allow for use with the right hand in one orientation, and then to allow for use with the left hand by simply flipping the handle (or rotating the cannula itself 180 degrees) to a second orientation. The handle generally includes a gripping portion and a housing. The gripping portion can be raised, recessed, grooved, or textured in certain areas to improve grip of the handle by the user or to improve user comfort. The housing can include an interior portion and a distal end. The interior portion of the housing can house the drive assembly and positioning elements (both of which are described further below). In some variations, the distal end of the housing includes a fluid port that can provide fluid for irrigation of the surgical field or to purge air from the system.

[0039] The universal handle may be made of any suitable material, including, but not limited to, fluoropolymers; thermoplastics, such as polyetheretherketone, polyethylene, polyethyleneterephthalate, polyurethane, and nylon; and silicone. In some variations, the housing or a portion of the housing may be made of a transparent material. Materials having 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, styrene methyl methacrylate (SMMA) copolymers (e.g., Zylar 631® acrylic copolymer).

[0040] The length of the universal handle can generally be between about 4 inches and 10 inches. In some variations, the length of the universal handle is about 7 inches.

[0041] The cannula of the ocular delivery system is typically coupled to and extends from the distal end of the housing and is generally configured to provide easy, minimally traumatic access to Schlemm's canal utilizing a minimally invasive ab-interno approach. Some variations of the cannula can include a proximal end and a distal curved portion, where the distal curved portion has a proximal end and a distal end and has a radius of curvature defined between the ends. The cannula can be further configured to include a body; a distal tip having a beveled surface; and a lumen extending from the proximal end through the distal tip. The beveled surface can directly engage the distal end of the curved portion of the cannula (i.e., the beveled surface can directly engage the radius of curvature).

[0042] The cannula may be made of any suitable material having sufficient stiffness to allow it to be advanced through the eye wall and anterior chamber. For example, the cannula may be formed of a metal, such as stainless steel, nickel, titanium, aluminum, or alloys thereof (e.g., Nitinol® metal alloy), or a polymer. Exemplary polymers include, but are not limited to, polycarbonate, polyetheretherketone (PEEK), polyethylene, polypropylene, polyimide, polyamide, polysulfone, polyether block amide (PEBAX), and fluoropolymers. In some instances, it may be advantageous to coat the cannula with a lubricious polymer to reduce friction between the ocular tissue and the cannula during the procedure. Lubricious polymers are well known in the art and include, but are not limited to, polyvinyl alcohol, polyethylene glycol, polyvinylpyrrolidone, fluorinated polymers (including polytetrafluoroethylene (PTFE or Teflon®)), and polyethylene oxide.

[0043] The cannula generally has an outer diameter sized to provide access to the lumen of Schlemm's canal while minimizing obstruction to the surgeon's view. Thus, the outer diameter may range from about 150 microns to about 800 microns. The cannula further has an inner diameter that may range from about 50 microns to about 400 microns. The cannula may further be formed to have any suitable cross-sectional profile, such as, for example, circular, elliptical, triangular, square, rectangular, etc.

[0044] The cannula may be configured to include multiple sections or parts. A cannula having a body, a distal curved section having a proximal end and a distal end, a radius of curvature defined between the ends, and a bevel at the distal tip of the cannula that directly engages the distal end of the curved section of the cannula may be particularly useful for accessing the lumen of Schlemm's canal. Here, the body (straight section of the cannula) may have a length ranging from about 5 mm to about 50 mm, about 10 mm to about 30 mm, or about 14 mm to about 20 mm. In some variations, the body may have a length of about 18 mm. The distal curved section of the cannula may be uniform in cross-sectional shape or may taper as it approaches the distal end to facilitate entry into Schlemm's canal. The radius of curvature of the distal curved portion may be adapted to facilitate tangential entry and, further, to facilitate precise and minimally traumatic entry into Schlemm's canal and may range from about 1 mm to about 10 mm or from about 2 mm to about 5 mm. In one variation, the radius of curvature is about 2.5 mm. The cannula may further have an angular span suitable for facilitating entry into Schlemm's canal and may range from about 70 degrees to about 170 degrees or from about 100 degrees to about 150 degrees. In one variation, the angular span is about 120 degrees.

[0045] The size, shape, geometry, etc. of the bevel at the distal end of the curved portion of the cannula can be beneficial in allowing easy, minimally traumatic access to Schlemm's Canal. In this regard, and as will be described in more detail below, it can be particularly useful to have a bevel that directly engages the radius of curvature of the distal end of the cannula.

[0046] In other variations, the cannula can include a short straight segment (e.g., at the end of the radius of curvature) coupled to the distal end of the distal curved portion of the cannula, where the bevel engages the straight segment and not the radius of curvature. The length of the straight segment can 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 about 0.5 mm to about 1 mm. The length of the straight segment can also be less than about 0.5 mm, for example, 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 does not have a straight segment (i.e., the length of the straight segment is zero).

[0047] Additionally, it may be useful to have a sharp, short bevel to minimize the distance any ocular device needs to move when implanted in Schlemm's canal. 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 an appropriate direction. For example, the bevel may be oriented to open toward the surgeon, or the bevel may be reversed to open away from the surgeon, or may be in any plane in between.

[0048] In a further variation, the cannula is configured to include one section that is sharp and another section that is blunt (e.g., beveled). This dual surface configuration of such a cannula may be advantageous because it may provide easy access to Schlemm's canal by piercing the trabecular meshwork while providing a weak dispersion force to the conduit as it is retracted into the cannula, to avoid cutting or severing the conduit due to retraction forces. For example, as shown in FIG. 27, the distal end 1500 of the cannula may have a sharp piercing tip 1502 and a smooth edge 1504 that defines a portion of an opening 1506 through which a slidable conduit (FIG. 28) may be advanced or retracted. The sharp tip 1502 may be formed by combining multiple bevels. The smooth edge 1504 may be created by laser cutting or beveling the inner bevel edge.

[0049] The drive assembly of the delivery system is generally configured to move the ocular device, the conduit, and / or the fluid composition out of the universal handle and into Schlemm's canal. The drive assembly may be further configured to position the ocular device in Schlemm's canal, including advancing the device into Schlemm's canal and retracting the device from Schlemm's canal. The drive assembly may be at least partially contained within the housing and may include any suitable component or combination of components capable of providing the handle with universal functionality. In some variations, the drive assembly includes a component that converts rotational motion to linear motion. For example, the drive assembly may include a linear gear and a pair of pinion gear mechanisms. The linear gear may have teeth on its surface that engage corresponding teeth on the pinion gear. Each of the pinion gear mechanisms may be further coupled to a rotatable component (e.g., a wheel). Such coupling can be achieved using a pin that can be threaded through a central opening in the rotatable component and the pinion gear, and a nut that secures the rotatable component and the pinion gear such that rotation of the rotatable component also rotates the pinion gear and vice versa. The wheel can be attached to the pinion gear in one of the following ways: 1) the wheel and the pinion gear are molded as one piece using plastic injection molding techniques; 2) the wheel is slid over the pinion gear and secured with an adhesive; or 3) the wheel is slid over the pinion gear and mechanically secured with a fastener, i.e., a "press fit," where the wheel is pressed over the pinion gear and friction holds them securely. In all of the mentioned situations, the wheel and the pinion gear can rotate coaxially in the same direction at equal angular velocities. In some variations, each of the pinion gear mechanisms is connected to at least two rotatable components. In other variations, the drive assembly may be configured to include a single rotatable component, multiple rotatable components, or no rotatable components. The wheels may have markings or colored portions to indicate the degree of advancement or direction of advancement.

[0050] One variation of the drive assembly that is useful for including a universal handle includes a linear gear, a pair of pinion gear mechanisms, and two rotatable components coupled to each pinion gear (for a total of four rotatable components). Here, the pinion gear mechanisms and associated wheels would be disposed on either side of the linear gear. The pinion gear and linear gear would contact each other, i.e., the teeth of the pinion gear would directly engage corresponding teeth on the linear gear, and the wheel on one side of the linear gear would contact the wheel on the opposite side of the linear gear. In this variation, the drive assembly can be operated with one hand when in a first configuration and with the other hand when flipped over to a second configuration. A drive assembly with such adaptability can be easily used by right or left handed surgeons. In another variation, the drive assembly can include one rotatable component on one side of the handle and a "universal" feature of the handle provided by the cannula that can rotate on its own instead of flipping the handle.

[0051] One or both pinion gear mechanisms may be disengaged from the linear gear by biasing its position off-axis from the linear gear. This action disengages the teeth of the pinion gear against the teeth of the linear gear, thereby preventing movement of the linear gear. The pinion gear mechanisms may also be locked to prevent rotation by engaging intersecting pins or structures that prevent rotation of the wheels.

[0052] In other variations, the drive assembly includes a linear gear and a single pinion gear mechanism with two associated wheels. Further variations of the drive assembly may not employ a conversion from rotary to linear motion. For example, a slide (e.g., a finger slide) on the handle that is fixed or removably coupled to a gear (e.g., a linear gear as already described) in the housing of the handle may be used to deliver the ocular device or the fluid composition. Here, the drive assembly may be configured such that advancing the slide accordingly advances the components that deliver the ocular device or the fluid composition into Schlemm's canal, and retracting the slide accordingly retracts these components. In further variations, a button that is pressed with one finger or squeezed with two fingers may be employed instead of a slide.

[0053] The ocular delivery system may further include a slidable positioning element disposed coaxially within the lumen of the cannula for controlled implantation of the ocular device within Schlemm's canal. The positioning element generally comprises a proximal end, a distal end, and an engagement mechanism at the distal end. The ocular device is generally 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 retracted to assist in positioning and / or repositioning the ocular device or disengagement of the ocular device from the engagement mechanism.

[0054] Some variations of the engagement mechanism include a coiled portion on the proximal side and a hook on the distal side. If an implant having at least one fenestration (e.g., a proximal fenestration) is to be implanted, the hook can be releasably engaged to the fenestration. The ocular device can be disengaged from the hook by applying a gentle force to the coil, or by another component that can be advanced over the coil to push the device away from the hook, or by using a shape memory material that passively disengages as it exits the cannula. It can be advantageous to use the hook when it is desired to retract the ocular device. The surgeon can simply move the delivery system and engagement mechanism to result in disengagement of any fenestrations or notches on the implant.

[0055] In another variation, the engagement mechanism includes opposing jaws. Here, the engagement mechanism can include a first jaw and a second jaw, where the jaws have a closed configuration and an open configuration. The jaws can be used to grip and manipulate the ocular device and to releasably couple the ocular device to the positioning element. The jaws can be formed by splitting or bifurcating the distal end of a wire, for example by laser cutting. The gripping force of the jaws can be obtained by constraining the jaws within the cannula. The ocular device can be released when the jaws are advanced out of the cannula and expanded. The jaws can further be pivotally connected. In another variation, the first jaw can include at least one tooth tip and the second jaw can include at least one aperture for receiving the tooth tip when the jaws are in the closed configuration.

[0056] In a further variation, the engagement mechanism comprises a loop portion. This variation of the engagement mechanism would typically be used with an ocular device that comprises a spring-like fastener at its proximal end, where the fastener has a folded configuration and an expanded configuration. The fastener is generally created in an expanded position. Thus, when the device with the fastener is disposed within the cannula, the first and second arms or tabs of the fastener can be folded around the loop portion of the engagement mechanism. When the fastener portion of the device is out of the cannula, the arms or tabs can expand to release the ocular device from the loop portion.

[0057] Yet another variation of the engagement mechanism includes a female-to-male interface. For example, the engagement mechanism can include a notch configured to interface with a complementary mating element (e.g., a tab) on the ocular device. The notch (female component) can be formed in the hypodermic tubing or can be made by creating a fenestration through the distal end of the positioning element made from a solid wire or element, and a tab or hook (male component) can be formed as part of the ocular device and inserted into the fenestration or notch in the positioning element. With this configuration, the ocular device can be released from the positioning element when advanced out of the cannula by the surgeon's manipulation, or by shape-locking of the positioning element to become passively detached from the ocular device, or both.

[0058] The system generally includes a reservoir where the fluid composition is delivered into Schlemm's canal. As will be further described below, the reservoir may be at least partially defined by the fluid assembly and housing, as well as the linear gear within the handle. The fluid assembly may be made from any suitable material as mentioned above for the cannula and housing. The volume (in microliters) of fluid contained within the reservoir may range from about 2 μl to about 1000 μl or from about 2 μl to about 500 μl. In some variations, the reservoir volume may range from about 50 μl to about 100 μl. Some variations of the fluid assembly include a locking mechanism to prevent the assembly from moving within the handle, for example, when the linear gear is advanced or retracted. The locking mechanism may include a ratchet pawl, a combination of ratchet pawls, or any other suitable mechanism that may be locked to prevent movement of the fluid assembly or unlocked to allow movement of the fluid assembly.

[0059] The fluid composition may be preloaded into the reservoir or may be loaded into the reservoir prior to use of the system, such as at the beginning of an ocular procedure, so that the fluid may be delivered by a single device and by a single user. Again, 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 a device containing a viscoelastic fluid that is separate or independent from the delivery catheter or catheter advancement tool, and that require connection to the delivery catheter or catheter advancement tool during the procedure by an assistant or by the surgeon's other hand while the delivery catheter or catheter advancement tool is held by one hand of the surgeon. For example, a loading component may be provided in the fluid assembly for transferring the fluid composition into the reservoir. The loading component may have any suitable configuration that provides for reversible fixation of a fluid container, such as a syringe, cartridge, etc., to the system and loading of the fluid composition into the reservoir. The loading component may be a luer fitting or may include a one-way valve. A slidable conduit disposed coaxially within the cannula lumen may be operatively connected to the reservoir for delivering the fluid composition into Schlemm's canal. The slidable conduit generally has a proximal end, a distal end, and a wall defining a conduit lumen extending through the proximal and distal ends. However, in some instances, the delivery system does not have a slidable conduit, and only the fluid composition is delivered through the cannula. In other instances, two slidable conduits may be employed, each of which advances simultaneously through Schlemm's canal in both a clockwise and counterclockwise direction, respectively, for more rapid cannulation of Schlemm's canal and for delivery therapy. As noted above, the fluid may be delivered in a volume that provides sufficient force to disrupt Schlemm's canal and the surrounding trabecular meshwork tissue.Exemplary disruption volumes can be about 1 μl, about 2 μl, about 3 μl, about 4 μl, about 5 μl, about 6 μl, about 7 μl, about 8 μl, about 9 μl, about 10 μl, about 11 μl, about 12 μl, about 13 μl, about 14 μl, about 15 μl, about 16 μl, about 17 μl, about 18 μl, about 19 μl, or about 20 μl. In some examples, the disruption volume of fluid can range from about 1 μl to about 50 μl or from about 20 μl to about 50 μl.

[0060] The slidable conduit may be made of any suitable material that provides the desired flexibility and pushability for introduction through the ocular wall, accessing Schlemm's canal, and / or navigating through other ocular tissue structures. For example, the conduit may include a polymer; a polymer reinforced with metal wire, metal braid, or metal coil; a composite of polymer and metal; or a metal, such as stainless steel, titanium, nitinol, or alloys thereof. The slidable conduit may be straight so as to have sufficient flexibility and pushability to navigate the ring-shaped Schlemm's canal, or may be preformed with a radius of curvature of about 2-10 mm or about 6 mm (i.e., the approximate radius of curvature of Schlemm's canal in an adult human) to easily circumnavigate a portion or the entirety of Schlemm's canal. In some other variations, the slidable conduit includes multiple openings through its wall spaced along the axial length of the conduit. In this variation, a fluid composition may be delivered from a reservoir through openings in the conduit into Schlemm's canal. Such lateral drainage of fluid (e.g., viscoelastic fluid) will further improve disruption of outflow tissue and increase permeability to aqueous humor. It will be appreciated that the openings may be of any suitable number, size, and shape and may be spaced along the axial length of the conduit (including the distal end) in any suitable manner. In other variations, the distal end of the slidable conduit may be configured or modified to aid in the delivery of fluid compositions into Schlemm's canal. For example, the distal end of the conduit may include a notch configured as a half tube. The distal end of the conduit may also be configured with a blunt bevel, an atraumatic tip, an enlarged atraumatic tip, or a roughened surface to disrupt the juxtacanalicular portion or juxtatrabecular meshwork of Schlemm's canal. In addition, the conduit can have one or more protrusions protruding from the conduit to further disrupt the juxtacanalicular portion of Schlemm's canal or the juxtacanalicular network, thereby improving the permeability of aqueous humor through the trabecular meshwork and into Schlemm's canal. In some examples, the conduit can also deliver energy to the trabecular canalicular tissue.In other examples, the conduit can be a commercially available or customized polypropylene suture (or other material). The suture can be sized to allow it to be advanced through the cannula to a portion of Schlemm's canal (e.g., from 0 degrees to 360 degrees of Schlemm's canal) to disrupt Schlemm's canal, insert a stent into Schlemm's canal, and / or tension Schlemm's canal and / or tear the trabecular canalicular tissue. An exemplary range of suture sizes can range from about 50 microns to about 300 microns. The suture can be removed from Schlemm's canal or left in Schlemm's canal to continue to deliver tension to the trabecular meshwork to maintain patency of Schlemm's canal.

[0061] The cannula of the system described herein can also deliver various surgical tools ab interno. For example, catheters, wires, probes, and other tools can be employed ab interno to access Schlemm's canal and create holes, partial thickness cuts, or penetrations at discrete locations or along the entire inner wall of the trabecular meshwork or Schlemm's canal. The surgeon can also advance tools across the entire Schlemm's canal and through the outer wall of the collection tract to access the sclera and subconjunctival space to make incisions to create scleral lakes into which aqueous humor can flow to the scleral veins or subconjunctival space, or to deliver ab interno resident ocular devices that flow from the anterior chamber or Schlemm's canal into the scleral lake or subconjunctival space (all again by ab interno approach).

[0062] The reservoir can contain various fluid compositions for delivery into Schlemm's canal. Exemplary fluid compositions include saline and viscoelastic fluids. The viscoelastic fluid can include hyaluronic acid, chondroitin sulfate, cellulose, derivatives or mixtures thereof, or solutions thereof. In one variation, the viscoelastic fluid includes sodium hyaluronate. In another variation, the viscoelastic composition can further include a drug. For example, the viscoelastic composition can include a drug suitable for treating glaucoma, reducing or lowering intraocular pressure, reducing inflammation, and / or preventing infection. Additionally, drugs such as antimetabolites, steroids, heparin, other anticoagulants, and fibrinolytic compounds can be delivered in combination 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 can also be used. Steroids such as, for example, prednisolone, prednisone, cortisone, cortisol, triamcinolone, or short-acting steroids may also be employed. Examples of antimetabolites include 5-fluorouracil, or mitomycin C. In yet another variation, the system delivers only the drug without the viscoelastic compound. Saline may also be the fluid employed.

[0063] In other variations, the device / system can include a slidable conduit that does not deliver fluid but is sized to have an outer diameter sufficient to disrupt Schlemm's canal and the surrounding trabecular meshwork tissue. The outer diameter can range from about 50 microns to about 500 microns, about 300 microns to about 500 microns, about 200 microns to about 250 microns, or about 180 microns to about 300 microns. In some instances, it may be beneficial for the conduit to have an outer diameter of about 240 microns. Additionally, the distal portion of the conduit can include disrupting components, such as, for example, notches, hooks, barbs, or combinations thereof, for disrupting tissue.

[0064] An exemplary ocular delivery system is depicted in FIG. 14. In this figure, delivery system 200 includes a universal handle 202 having a gripping 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 distal end 210 of the housing. A drive assembly 214 that actuates movement of a positioning element (not shown) is substantially contained within the housing 206. A port 216 is provided at the distal end of the housing 210 for removable connection to a source of irrigation fluid.

[0065] The cannula of the exemplary delivery system is shown in more detail in FIG. 15. Here, the cannula 300 comprises 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 has a radius of curvature R defined between the distal ends 308 and 310. A bevel 312 at the distal end 306 directly engages the distal end of the curved portion of the cannula 310. In other words, the bevel 312 may be continuous with the distal end of the curved portion of the cannula 310. As mentioned above, this configuration of the distal curved portion 304 and the bevel 312 may be beneficial or advantageous for easy, atraumatic, and controlled access into Schlemm's canal. The angle of the bevel may also be important. In general, a short bevel may be beneficial. Here, the bevel angle A is about 35 degrees.

[0066] Ocular delivery systems generally include a drive assembly substantially contained within a housing. In the variation shown in FIG. 16A, the delivery system 400 includes a drive assembly 402 having a linear gear 404 (e.g., a rack) and a pair of pinion gear mechanisms 406. Both the linear gear and the pinion gear mechanism have teeth that engage with each other to convert rotational motion (of the pinion gear mechanism 406) into linear motion (of the linear gear 404). Each of the pinion gear mechanisms 406 is coupled to two rotatable components, shown here as wheels 408, for a total of four rotatable components. The wheels 408 can be rotated by one or more of the surgeon's fingers, which accordingly rotates the pinion gear mechanism 406 and thereby advances or retracts the linear gear 404. The wheels 408 are coaxial with the pinion gear mechanism 406 and rotate in unison therewith. Movement of linear gear 404 advances or retracts positioning element 410, which is coaxially disposed within and slidable within cannula 412. Figure 16B shows the system of Figure 16A in a second, reversed orientation that can be used with the opposite hand (e.g., left hand if the system of Figure 16A is used with the right hand) or by the same hand, but with cannulation desirably in a different direction (e.g., clockwise cannulation if counterclockwise cannulation is performed with the system of Figure 16A).

[0067] When the delivery system is used with an ocular device, the cannula can have a slidable positioning element disposed coaxially within the cannula lumen. The slidable positioning element generally includes an engagement mechanism for manipulating the ocular device, e.g., by releasably engaging the ocular device, advancing the ocular device, and / or retracting the ocular device. Exemplary engagement mechanisms are depicted in Figures 17-21.

[0068] In FIG. 17A, the engagement mechanism 500 comprises a first jaw 502 and a second jaw 504. In their closed configuration (as shown in FIG. 17A), the jaws 502, 504 are constrained within a cannula 512 to hold an ocular device 506 comprising a support 508 and at least one fenestration 510. When the jaws 502, 504 are advanced out of the cannula 512, the jaws 502, 504 are no longer constrained and thus assume their open configuration as shown in FIG. 17B. Opening the jaws 502, 504 releases the ocular device 506 from the engagement mechanism 500. At least one tooth tip 514 may be provided in the first jaw 502 and at least one aperture 516 may be provided in the second jaw 504 to assist in securing the fenestrated ocular device when the jaws are in their closed configuration. In FIG. 18, a variation of the engagement mechanism 600 is shown in which the first jaw 602 and the second jaw 604 include both teeth 606 and apertures 608 to assist in gripping the fenestrated ocular device 610.

[0069] 19A-19B, another exemplary engagement feature is depicted. In Fig. 19A, engagement feature 700 includes complementary mating elements.

[0070] Specifically, the engagement mechanism 700 includes a notch 702 in a female element configured to interface with a complementary male element 704, shown as a hook-like protrusion on the ocular device 706. Here, the notch 702 may be made at the end of a hypodermic tube 708 (which will function as the positioning element). Instead of a notch 702, the female element of the engagement mechanism 710 may also include an opening 712, as shown in FIG. 19B, that interfaces with the male element 704 on the ocular device 706. In FIG. 19B, the positioning element 714 may be made from a metal wire or rod, and the opening 712 may be created via laser machining or other processes known in the art.

[0071] In other variations, the engagement mechanism may be configured as shown in Figures 20A and 20B. In these figures, the engagement mechanism 800 comprises a loop portion 802. It may be beneficial to use this particular engagement mechanism with an ocular device 804 that includes a fastener 806 having an arm or tab 808 with a closed configuration and an expanded configuration. Similar to the variation shown in Figures 17A and 17B, the tab 808 is constrained in its closed configuration within the cannula 810 before being advanced out of the cannula 810. In its constrained configuration, the tab 808 engages the loop portion 802 of the engagement mechanism 800, thereby preventing the ocular device 804 from being released from the system. When the loop portion 802 of the engagement mechanism 800 is advanced far enough that the cannula 810 no longer constrains the tab 808, the tab 808 assumes its expanded configuration, thus releasing the ocular device 804 from the loop portion 802 and into Schlemm's canal, as shown in Figure 20B.

[0072] Another example engagement mechanism 900 is shown in FIG. 21 comprising a coiled portion 902 and a hook 904. If an ocular device 906 having at least one fenestration 908 (e.g., a proximal fenestration) is to be implanted, the hook 904 may be releasably engaged to the fenestration 908. The ocular device 906 may be disengaged from the hook by applying a gentle force to the coil 902 or by another component (not shown) that may be advanced over the coil 902 to push the device 906 away from the hook 904. It may be advantageous to use the hook 904 when it is desired to retract the ocular device 906.

[0073] When the delivery system is employed to deliver a fluid composition, the fluid composition may be preloaded into the reservoir of the system or may be loaded into the reservoir prior to use of the system. An exemplary delivery system for delivering a fluid composition into Schlemm's canal is shown in FIGS. 22A and 22B. Referring to FIG. 22A, a delivery system 1000 includes a universal handle 1002 having a gripping 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 and extends from the distal end 1010 of the housing. A drive assembly 1014 that actuates movement of a slidable conduit (not shown) is substantially contained within the housing 1006. The cannula 1012 and drive assembly 1014 have the same configuration as shown and described in Figures 15 and 16A-16B for a system adapted for implantation of an ocular device, and therefore will not be described in detail here.

[0074] The delivery system 1000 further includes a fluid assembly 1016 (shown in FIG. 22B) within the handle 1002 having a loading component 1018 configured to enable transfer of a fluid composition from an external source into a reservoir defined by the fluid assembly and a linear gear 1020. A slidable conduit 1022 is coaxially disposed within the cannula lumen in fluid communication with the reservoir. As previously mentioned, in tool-based systems that do not deliver implants or fluids, the system may not include a reservoir.

[0075] In an exemplary method, as shown in Figures 23A-23C, a fluid composition may be transferred into a reservoir 1102 of a system 1100 via loading through a loading component 1104. As shown in the figure, the reservoir 1102 is defined by a fluid assembly 1106 and a 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 a lumen (not shown) of a slidable conduit 1118.

[0076] To deploy the fluid composition out of the reservoir 1102, the linear gear 1108 is retracted in the direction of the arrow (FIG. 23B), thereby pressurizing the reservoir 1102. Retraction can be accomplished by rotating the pinion gear mechanism 1120. When a sufficient amount of pressure is created within the reservoir 1102, the fluid composition contained therein is injected through the linear gear lumen 1114 and the conduit 1118 into Schlemm's canal.

[0077] The slidable conduit employed with the systems described herein can be of various configurations. For example, as shown in FIG. 24, the conduit 1200 can be a flexible tube having a lumen fluidly connected to an opening at the distal end 1202, where any fluid delivered flows through the distal end 1202 to reach Schlemm's canal. In other variations, the slidable conduit 1300 can be configured to include multiple openings spaced apart along its axial length. The openings can have any suitable shape, such as, for example, a slot (FIG. 25A) or a circle 1304 (FIG. 25B). A fluid composition delivered using the conduit depicted in FIG. 25A and FIG. 25B can flow partially out of the conduit through the openings and partially out through the distal end of the conduit. The distal end of the conduit can be further configured as a half tube 1306 (FIG. 25C).

[0078] Methods for implanting the ocular device and for delivering fluid compositions into Schlemm's canal using the above-mentioned system are further provided. Implant-free methods for providing a force sufficient to disrupt trabecular meshwork tissue, for example by providing a disruption volume of viscoelastic fluid or a disruption tool, are further described. These methods are generally minimally invasive, one-handed, single-operator controlled methods, for example, tailored for the already mentioned ab interno procedures, which may be advantageous over the more invasive ab externo approach. However, using the present ocular system in an ab externo procedure may also be contemplated in some instances and is therefore not excluded here. The ocular device or the method for delivering fluids or providing disruption forces may be used to treat glaucoma, early glaucoma, or ocular hypertension. When treating glaucoma, the present method may also be used in conjunction with cataract surgery (before or after) using the same incision.

[0079] In general, a method for implanting an ocular device into Schlemm's canal includes first creating an incision in the ocular wall (e.g., sclera or cornea) that provides access to the anterior chamber of the eye. As shown in the stylized depiction of the eye in FIG. 26, a cannula 1400 of an ocular delivery system is then advanced through the incision and at least partially across the anterior chamber 1402 to the trabecular meshwork (not shown). A distal curved portion of the cannula 1406 and a slidable positioning element (or, for example, a slidable tool or guidewire) is used to access Schlemm's canal 1404 (i.e., the lumen of Schlemm's canal) or a slidable conduit (collectively represented as element 1408) is advanced from the cannula to implant an ocular device into Schlemm's canal, perform a procedure within Schlemm's canal or any of the adjacent trabecular canalicular tissue, or deliver fluid into Schlemm's canal. However, in some instances, a slidable conduit may not be employed, such that any fluid to be delivered is delivered through the cannula. In yet a further variation, only the trabecular meshwork is pierced and the fluid composition is delivered without circumnavigating Schlemm's canal.

[0080] As previously mentioned, the cannula may be configured to include a proximal end and a distal curved portion, where the distal curved portion has a proximal end, a distal end, and a radius of curvature defined between the ends. Here, the cannula may further include a body and a distal tip having a beveled surface that directly engages the radius of curvature, e.g., the beveled surface is continuous with the radius of curvature. The method may further include flushing the system with a fluid (e.g., to remove air from the system) and / or irrigating the surgical field to remove blood or otherwise improve visualization of the surgical field.

[0081] Any suitable ocular device that maintains the patency of Schlemm's canal or improves the outflow of aqueous humor may be implanted by the system described herein. For example, an ocular device that spans Schlemm's canal and maintains the patency of Schlemm's canal without substantially interfering with fluid flow along the canal may be implanted. Such a device may include a support with at least one fenestration. Ocular devices that disrupt the juxtacanalicular trabecular meshwork or the adjacent inner wall of Schlemm's canal may also be implanted. In addition to ocular devices made of metals or metal alloys, sutures, modified sutures, modified polymers, or solid viscoelastic structures may also be delivered. Fluid compounds such as saline, viscoelastic fluids, air, and gases may also be delivered.

[0082] When the fluid composition is delivered into Schlemm's canal, the method generally includes the steps of: creating 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 across the anterior chamber to the trabecular meshwork; accessing Schlemm's canal with the cannula; and delivering the fluid composition into Schlemm's canal using a conduit that is slidable within the cannula lumen. The cannula may be configured to include a proximal end and a distal curved portion, where the distal curved portion has a proximal end, a distal end, and a radius of curvature defined between the ends. Here, the cannula may further include a body and a distal tip having a bevel that directly engages the radius of curvature, for example, the bevel is continuous with the radius of curvature. Additional advantageous cannula structures as described above may also be included. The method may further include flushing the system with a fluid (e.g., to remove air from the system) and / or washing the surgical field to remove blood or otherwise improve visualization of the surgical field.

[0083] When the ab interno technique is employed to implant the ocular device, the method may include the following steps: First, the surgeon may use an operating microscope and a gonioscope or gonioprism to view the anterior chamber and trabecular meshwork (along with the underlying Schlemm's canal). Then, using a corneal incision of 0.5 mm or more, a limbal incision, or a scleral incision, the surgeon may achieve access to the anterior chamber. Then, saline or a viscoelastic compound may be introduced into the anterior chamber to prevent it from collapsing. Here, the saline or viscoelastic compound may be delivered through a delivery system cannula, or may be delivered in a separate form, for example, injected through a sleeve that is on the cannula. Under direct visualization by the microscope, the surgeon may advance the delivery system cannula through the incision toward the anterior chamber angle. Once the anterior chamber angle (and thus the trabecular meshwork) is close, the surgeon may apply a gonioscope or gonioprism to the cornea to visualize the anterior chamber angle. Applying a viscous fluid (e.g., a viscoelastic compound as described above) to the cornea and / or gonioscope or gonioprism can help achieve good optical contact. Once the surgeon has visualized the trabecular meshwork, the cannula can be advanced so that the bevel at the distal end of the curved distal portion of the cannula pierces the trabecular meshwork and communicates with the lumen of Schlemm's canal. The surgeon can irrigate saline or a viscoelastic compound into Schlemm's canal or the anterior chamber to either prevent the anterior chamber from collapsing, to dilate Schlemm's canal, or to flush out any blood that may obscure visualization of the delivery of the cannula and ocular device. The ocular device is then advanced to the extent desired by the surgeon, and the ocular device is released from the engagement mechanism, allowing the ocular device to remain in Schlemm's canal. If it becomes necessary or desirable to reposition the ocular device, the surgeon can retract and / or reposition the ocular device using the positioning elements of the delivery system. The surgeon can then retract the delivery system from the eye.

[0084] Other variations of the ab interno technique for implanting ocular devices include the use of an endoscope. As with the above method, the anterior chamber is first accessed by making an incision in the cornea, limbus, or sclera. Again, this can be done simultaneously in combination with cataract surgery, before or after cataract surgery, or independently. Saline can be injected into the anterior chamber, or a viscoelastic compound can be placed in the anterior chamber to prevent it from collapsing. The saline or viscoelastic can be delivered in a separate step, or the saline or viscoelastic can be injected using a conduit of the delivery system, a sleeve on the conduit, or a separate injection cannula. The surgeon then advances the endoscope through the incision toward the anterior chamber angle and trabecular meshwork under direct visualization with the microscope. As the surgeon visualizes the trabecular meshwork using the endoscope or any attached video display, the bevel of the cannula is advanced to perforate the trabecular meshwork. The ocular device is then advanced using the positioning element under microscopic visualization. The surgeon may irrigate saline or a viscoelastic compound into Schlemm's canal or the anterior chamber to either prevent the anterior chamber from collapsing, to dilate Schlemm's canal, or to flush out any blood that may obscure visualization of the delivery of the cannula and ocular device. Once the ocular device has been advanced to the extent desired by the surgeon, the ocular device is released from the engagement mechanism, thereby allowing the ocular device to remain within Schlemm's canal. If it becomes necessary or desired to reposition the ocular device, the surgeon may retract and / or advance the ocular device using the positioning element of the delivery system. The delivery system may then be retracted from the eye by the surgeon.

[0085] With regard to the delivery of the fluid composition, the method is similar to the implantation of an ocular device. However, instead of using a positioning element, the delivery system employs a slidable conduit to inject the fluid composition into Schlemm's canal. First, the surgeon can use an operating microscope and a gonioscope or gonioprism to view the anterior chamber and trabecular meshwork (along with the underlying Schlemm's canal). Then, using a corneal incision of 0.5 mm or more, a limbal incision, or a scleral incision, the surgeon can achieve access to the anterior chamber. Then, saline or a viscoelastic composition can be introduced into the anterior chamber to prevent it from collapsing. Here, the saline or viscoelastic composition can be delivered through the delivery system cannula, or it can be delivered in another form, for example, injected through a sleeve on the cannula. Then, under direct visualization with the microscope, the surgeon can advance the delivery system cannula through the incision toward the anterior chamber angle. Once the anterior chamber angle (and thus the trabecular meshwork) is approached, the surgeon can apply a gonioscope or gonioprism to the cornea to visualize the anterior chamber angle. Applying a viscous fluid (e.g., a viscoelastic compound as described above) to the cornea and / or the gonioscope or gonioprism can assist in achieving good optical contact. Once the surgeon has visualized the trabecular meshwork, the cannula can be advanced so that the bevel at the distal end of the curved distal portion of the cannula pierces the trabecular meshwork and communicates with the lumen of Schlemm's canal. A slidable conduit disposed coaxially within the cannula lumen can then be advanced into Schlemm's canal under gonioscopic visualization. The slidable conduit can be advanced to any suitable extent and direction around Schlemm's canal. For example, the slidable conduit may be advanced between about 10 degrees and about 360 degrees around Schlemm's canal, or the slidable conduit may be advanced in two steps, such as 180 degrees in a clockwise direction and 180 degrees in a counterclockwise direction around Schlemm's canal (e.g., to achieve a full 360 degree ab interno viscocanalostomy or canaloplasty). As the conduit is advanced or retracted, fluid may be injected.Once the slidable conduit is positioned within Schlemm's canal, a fluid composition, such as a viscoelastic solution, can be delivered through the conduit, either continuously or intermittently. The fluid composition can exit the conduit through the distal end of the conduit (e.g., through the distal tip), or through openings or fenestrations provided along its shaft, or a combination of both. The openings or fenestrations can be spaced along the axial length of the conduit in any suitable manner, e.g., symmetrical or asymmetrical along its length. If desired, other substances, such as drugs, air, or gases, can be delivered in the same manner.

[0086] The slidable conduit may be repositioned by being retracted or by repeated advancement and retraction. In some variations of the method, the same or different incisions may be used, but the delivery system cannula is employed to access and dilate Schlemm's canal from a different direction (e.g., counterclockwise instead of clockwise). Once a sufficient amount of fluid has been delivered, the surgeon may retract the slidable conduit into the cannula and the delivery system may be removed from the eye. It is understood that these steps may be used alone or in combination (concurrently) with cataract surgery.

[0087] Other variations of the ab interno technique for delivering the fluid composition include the use of an endoscope. As with the method described immediately above, the anterior chamber is first accessed by making an incision in the cornea, limbus, or sclera. Again, this can be done simultaneously in combination with cataract surgery, before or after cataract surgery, or independently. Saline can be injected into the anterior chamber, or a viscoelastic composition can be placed in the anterior chamber to prevent it from collapsing. The saline or viscoelastic can be delivered in a separate step, or the saline or viscoelastic can be injected using a conduit of the delivery system, a sleeve on the conduit, or a separate injection cannula. The surgeon then advances the endoscope through the incision toward the anterior chamber angle and trabecular meshwork under direct visualization with the microscope. As the surgeon visualizes the trabecular meshwork through the endoscope or through any attached display, the bevel of the cannula is advanced to pierce the trabecular meshwork. The slidable conduit is then advanced under microscopic visualization. The slidable conduit may be advanced any suitable extent and direction around Schlemm's canal. For example, the slidable conduit may be advanced between about 10 degrees and about 360 degrees around Schlemm's canal, or the slidable conduit may be advanced in two steps, such as 180 degrees clockwise and 180 degrees counterclockwise around Schlemm's canal (to achieve a full 360 degrees ab interno viscocanalostomy). Once the slidable conduit is positioned within Schlemm's canal, a fluid composition, such as a viscoelastic solution, may be delivered through the conduit, either continuously or intermittently. The fluid composition may exit the conduit through the distal end of the conduit (e.g., through the distal tip), or through openings or fenestrations along its shaft, or a combination of both. The openings or fenestrations may be spaced along the axial length of the conduit in any suitable manner, e.g., symmetrical or asymmetrical along its length. If desired, other substances such as drugs, air, or gases may be delivered in a similar manner.

[0088] The slidable conduit may be repositioned by being retracted or by repeated advancement and retraction. In some variations of the method, the same or a different incision may be used, but the delivery system cannula is employed to access and dilate Schlemm's canal from a different direction (e.g., counterclockwise instead of clockwise). Once a sufficient amount of fluid has been delivered, the surgeon can retract the slidable conduit into the cannula and the delivery system can be removed from the eye.

[0089] The ab-externo approach for implanting an ocular device or delivering a fluid composition may include additional or slightly different steps. For example, formation of a tissue flap, suturing, etc. may be part of the ab-externo procedure. In general, the ab-externo procedure for implanting an ocular device may include the following steps: First, under microscopic visualization, the conjunctiva is incised, a scleral flap is formed, and tissue is cut to identify a hole into Schlemm's canal. The anterior chamber may be separately infused with saline or may have a viscoelastic composition placed therein to prevent the anterior chamber angle from collapsing. This operation may be performed as an independent procedure or may be performed simultaneously in combination with cataract surgery. This operation may be performed before or after cataract surgery.

[0090] Using the delivery system described herein, a cannula may be advanced into Schlemm's canal under direct microscopic visualization or through a gonioscope or gonioprism, and a positioning element may be used to advance an ocular device. Once the ocular device has been advanced to the desired extent, a surgeon may release the ocular device from the positioning element by actuating an engagement mechanism, and the delivery system may be removed from the eye and surgical field. The scleral wound is then closed, for example, using sutures or tissue adhesive. If it is necessary or desired to reposition the ocular device, a surgeon may retract and / or advance the ocular device using the positioning element of the delivery system.

[0091] In terms of delivery of the fluid composition, the ab externo method is similar to ab interno delivery. However, instead of using a positioning element, the delivery system employs a slidable conduit to inject the fluid composition into Schlemm's canal. First, under microscopic visualization, the conjunctiva is incised, a scleral flap is formed, and tissue is cut to identify a small hole into Schlemm's canal. The anterior chamber can be separately injected with saline or can have a viscoelastic composition placed therein to prevent the anterior chamber angle from collapsing. This operation can be performed as an independent procedure or can be performed simultaneously in combination with cataract surgery. This operation may be performed before or after cataract surgery.

[0092] Using the delivery system described herein, a cannula may be advanced into Schlemm's canal under gonioscopic visualization, and a slidable conduit disposed coaxially within the cannula lumen may be advanced into Schlemm's canal. Once the slidable conduit is positioned within Schlemm's canal, a fluid composition, such as a viscoelastic fluid, may be delivered continuously or intermittently through the conduit. The fluid composition may exit the conduit through the distal end of the conduit (e.g., through the distal tip), or through openings or fenestrations disposed along its shaft, or a combination of both. The openings or fenestrations may be spaced along the axial length of the conduit in any suitable manner, e.g., symmetrical or asymmetrical along its length. If desired, other substances, such as drugs, air, or gases, may be delivered in a similar manner. The slidable conduit may be repositioned by being retracted, or by being repeatedly advanced and retracted. The delivery system may then be removed from the eye.

[0093] The fluid composition may be delivered in such a manner that retracting the system components allows for the advancement of the fluid out of the system cannula. Referring again to FIGS. 23A-23C, the linear gear 1108 is retracted in the direction of the arrow (FIG. 23B), which causes the reservoir 1102 to be pressurized. Retraction may be accomplished by rotating the pinion gear mechanism 1120. When a sufficient amount of pressure is created within the reservoir 1102, the fluid composition contained therein is injected into Schlemm's canal through the linear gear lumen 1114 and the conduit 1118. It should be understood that the ocular delivery system may be configured to deliver the fluid composition continuously, passively, automatically, or actively by the surgeon. The fluid composition may also be delivered to Schlemm's canal using a pump or auxiliary plunger independent of the gear shaft movement.

[0094] Fluid compositions that may be delivered by the ocular system described herein 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, reducing or lowering intraocular pressure, reducing inflammation or wounds, and / or preventing infection. The viscoelastic composition may further include a solvent to aid in visualization of the viscoelastic composition. For example, a dye such as, but not limited to, fluorescein, trypan blue, or indocyanine green may be included. In some variations, a fluorescent or bioluminescent compound is included in the viscoelastic composition to aid in visualization of the viscoelastic composition. In other variations, the system delivers only the drug without the viscoelastic composition. In this case, the drug may be loaded onto or into a sustained release biodegradable polymer that elutes the drug over a period of weeks, months, or years. It is also contemplated that the system may be used to deliver air or gas.

[0095] The fluid composition may be delivered to dilate Schlemm's canal. The entire length of Schlemm's canal or a portion of Schlemm's canal may be dilated by the fluid. For example, at least 75%, at least 50%, at least 25%, or at least 10% of Schlemm's canal may be dilated. The fluid composition may further be delivered to treat a variety of medical conditions, including, but not limited to, glaucoma, early glaucoma, and ocular hypertension.

[0096] In addition, the fluid composition may be delivered to restore the tubular anatomy of Schlemm's canal, to remove obstructions in Schlemm's canal, to disrupt the paracanalicular trabecular meshwork or the inner wall of Schlemm's canal in Schlemm's canal, or to enlarge Schlemm's canal. Here, the delivery system may include wires, tubes, balloons, instruments for delivering energy to tissue, and / or other structures to assist in these methods. It is also contemplated that such systems with additional structures may be used to treat glaucoma. Furthermore, the surfaces of these systems may be roughened or have protrusions to further disrupt the inner wall of Schlemm's canal and the paracanalicular trabecular meshwork to improve aqueous humor outflow or increase permeability.

[0097] When the systems and devices are adapted to provide a disruption force to the trabecular meshwork tissue, an implant-free method may be employed, for example, by delivering a disruption volume of viscoelastic fluid or by advancing a disruption tool, such as, for example, a cannula, conduit, catheter, etc., including one or more disruption components at its distal portion, or both. Exemplary disruption 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, the disruption force may be generated to partially or completely disrupt and / or remove the trabecular meshwork and may be adjusted by varying the volume of viscoelastic fluid delivered or by changing the configuration of the tool. Exemplary volumes of viscoelastic fluid that may be sufficient to provide a disruption force may range from about 1 μl to about 50 μl, about 1 μl to about 30 μl, or about 2 μl to about 16 μl. In one variation, a volume of about 4 μl is sufficient to disrupt Schlemm's canal and / or surrounding tissue. In other variations, the volume of viscoelastic fluid sufficient to disrupt trabecular meshwork canalicular tissue can be about 2 μl, about 3 μl, about 4 μl, about 5 μl, about 6 μl, about 7 μl, about 8 μl, about 9 μl, about 10 μl, about 11 μl, about 12 μl, about 13 μl, about 14 μl, about 15 μl, about 16 μl, about 17 μl, about 18 μl, about 19 μl, about 20 μl, about 25 μl, about 30 μl, about 35 μl, about 40 μl, about 45 μl, or about 50 μl. The total volume of viscoelastic fluid can be delivered along a 360 degree arc 1600 of Schlemm's canal during a single advancement from a single access point 1602 within Schlemm's canal (as shown in FIG. 28) or during retraction of the conduit 1604, or along smaller arcs during multiple advancements or retractions of the conduit.

[0098] For example, as shown in FIG. 29, a conduit 1700 can be advanced along a 180 degree arc of Schlemm's canal in both a clockwise 1702 and counterclockwise 1704 direction to deliver fluid from, for example, a single access point 1706 within Schlemm's canal. With reference to FIGS. 28 and 29, an exemplary disruption volume of 4 μl can be delivered along a 360 degree arc of Schlemm's canal while the conduit is advanced from a single access point within Schlemm's canal, or 2 μl can be delivered along a 180 degree arc of Schlemm's canal during two advancements of the conduit from a single access point within Schlemm's canal, one in a clockwise direction and one in a counterclockwise direction. The conduit can access Schlemm's canal from a single point or multiple points. The size or extent of tissue disruption can be varied depending on the volume of fluid delivered. For example, 8 μl may be used to penetrate or slightly tear the trabecular meshwork, whereas 16 μl may be used to maximally tear the trabecular meshwork. More specifically, about 1 μl to 2 μl may be used to dilate Schlemm's canal and the payload tract; about 2 μl to 4 μl may be used to dilate Schlemm's canal and the payload tract and to disrupt / stretch the juxtacanalicular tissue; about 4 μl to 6 μl may be used for all of the above, as well as to create very small tears in the trabecular meshwork and the juxtacanalicular tissue (further increasing porosity and increasing outflow). About 8 μl to 16 μl volumes may be used for all of the above, as well as for substantial penetration / tear of the trabecular meshwork and the juxtacanalicular tissue. About 16 μl to 50 μl volumes may be used to substantially or completely tear the trabecular meshwork. When no fluid is used and only a cutting tool is employed, the outer diameter of the conduit or tool can be sized differently to cut tissue, similar to how fluid volume can be varied to vary the level of cutting.

[0099] For example, a conduit or tool having an outer diameter in the range of about 50 microns to about 100 microns may be advanced through Schlemm's canal to slightly dilate Schlemm's canal and to break or remove septa that impede circumferential canalicular flow. A conduit or tool having an outer diameter in the range of about 100 microns to about 200 microns may be employed to accomplish the above, and may also be employed to begin to stretch the trabecular meshwork and juxtacanalicular tissue. A conduit or tool having an outer diameter in the range of about 200 microns to about 300 microns may be able to accomplish the above, but may also create very small tears in the trabecular meshwork and juxtacanalicular tissue and maximize the dilation of the return passage. A conduit or tool having an outer diameter in the range of about 300 microns to about 500 microns may maximize the disruption of the tissue and create tears or perforations along the entire length of the trabecular meshwork and juxtacanalicular tissue. Additionally, advancing the conduit or tool further through Schlemm's canal may further increase the effectiveness of the procedure. For example, the conduit or tool may be advanced out of the tip of the cannula and into Schlemm's canal through about a 30 degree arc of Schlemm's canal (e.g., advanced about 3 to 4 mm out of the cannula), through about a 60 degree arc of Schlemm's canal (e.g., advanced about 6 to 8 mm out of the cannula), through about a 90 degree arc of Schlemm's canal (e.g., advanced about 10 mm out of the cannula), through about a 120 degree arc of Schlemm's canal (e.g., advanced about 15 mm out of the cannula), through about a 180 degree arc of Schlemm's canal (e.g., advanced about 20 m out of the cannula), or advanced completely about 360 degrees of Schlemm's canal (e.g., advanced about 36 to 40 mm out of the cannula) to maximize effectiveness and maximize intraocular pressure reduction.

[0100] An implant-free method for treating an eye condition can include advancing a conduit into Schlemm's canal, the conduit being loaded with a volume of viscoelastic fluid, and delivering a viscoelastic fluid into Schlemm's canal in a volume sufficient to disrupt trabecular canalicular tissue to reduce intraocular pressure. However, an implant-free method for treating an eye condition may not necessarily include delivery of a viscoelastic fluid. In these examples, the method can include advancing a device into Schlemm's canal, where the device has a diameter of between about 300 microns and about 500 microns or between about 150 microns and about 200 microns, where advancing the device into Schlemm's canal disrupts Schlemm's canal and / or trabecular canalicular tissue sufficiently to reduce intraocular pressure.

[0101] Another method for treating an eye condition can be a one-handed, single operator method for introducing a viscoelastic fluid into Schlemm's canal, which includes advancing a conduit into Schlemm's canal (the conduit is loaded with a volume of viscoelastic fluid) and delivering the viscoelastic fluid into Schlemm's canal (delivery of the volume of viscoelastic fluid is accomplished by a one-handed device used by a single operator).

[0102] Again, when the viscoelastic fluid is delivered in the manner disclosed herein, the disruption volume can be between about 2 μl and about 8 μl. It may be beneficial to deliver a volume of about 4 μl of viscoelastic fluid in certain instances. The viscoelastic fluid can be delivered while the conduit of the device controlled by a single operator in a single hand is advanced from Schlemm's canal or while the conduit is retracted from Schlemm's canal in a clockwise direction, a counterclockwise direction, or both. As previously mentioned, the viscoelastic fluid can be delivered to disrupt Schlemm's canal and the surrounding trabecular meshwork canalicular tissue. For example, the delivered viscoelastic fluid can cause disruption by dilating Schlemm's canal, increasing the porosity of the trabecular meshwork, stretching the trabecular meshwork, forming very small tears in the paracanalicular tissue, removing septa from Schlemm's canal, expanding the return channel, or a combination thereof. The conduit can be loaded with viscoelastic fluid at the start of the ocular procedure so that the fluid can be delivered by a single device. This is in contrast to other systems that use forceps or other advancement tools to advance the fluid delivery catheter into Schlemm's canal and / or a viscoelastic fluid-containing device that is separate or independent from the delivery catheter or catheter advancement tool, and that require connection to the delivery catheter or catheter advancement tool during the procedure by an assistant while the delivery catheter or catheter advancement tool is held by the surgeon.

[0103] In some variations, the methods disclosed herein may include advancement of the conduit (or tool) in an arc of about 360 degrees of Schlemm's canal, in an arc of about 270 degrees of Schlemm's canal, in an arc of about 120 degrees of Schlemm's canal, in an arc of about 180 degrees of Schlemm's canal, or in an arc of about 90 degrees of Schlemm's canal. In further variations, advancement of the conduit (or tool) may be in an arc of about 0 to 5 degrees of Schlemm's canal, in an arc of about 30 degrees of Schlemm's canal, or in an arc of about 60 degrees of Schlemm's canal. Advancement may be from a single access point in Schlemm's canal or from multiple access points in Schlemm's canal. When a disruption force is to be provided, it may be beneficial to advance the conduit in both clockwise and counterclockwise directions in an arc of about 180 degrees of Schlemm's canal from a single access point in Schlemm's canal.

[0104] Prior to the introduction of goniotomy and trabeculotomy (both commonly used to treat hereditary obstructed trabecular meshwork, often at an early age), congenital glaucoma was uniformly blinding. Even with goniotomy (performed ab interno, where a sharp scalpel is used to cut the trabecular meshwork at 30-60 degrees to improve outflow) and trabeculotomy (ab externo, where a deep scalpel incision is made to fenestrate Schlemm's canal and the trabecular meshwork is cut with a probe), these procedures have been deemed effective and have enabled many pediatric patients to avoid lifelong blindness. In 1960, Burian and Smith independently described the ab externo technique of trabeculotomy. In this highly invasive ab-external operation, the surgeon makes a deep scalpel incision, locates Schlemm's canal, cannulate the entire 360 ​​degrees of Schlemm's canal from the outside with a catheter or a specially designed probe called a trabeculotome, and finally applies tension to both ends of the catheter or probe to the extent that the trabeculotome cuts the entire trabecular meshwork into the anterior chamber to improve drainage.

[0105] Recently, an attempt to make ab externo trabeculotomy less invasive has been made by NeoMedix, which markets a device called “Trabectome.” Trabectome attempts to make trabeculotomy easier by utilizing an ab interno approach. These instruments and methods involve the removal of the trabecular meshwork in an ab interno manner with electrocautery using an instrument that provides injection and aspiration. The disadvantages of Trabectome are threefold: 1) the device employs an energy-based mechanism to cauterize the trabecular meshwork, which may cause irritation and trauma to the eye, which may further adversely affect outflow and pressure; 2) the ergonomic constraints of the device / procedure require a foot pedal and power cord to activate the electrocautery, and in addition, irrigation is limited to treating only 60°-120° of trabecular meshwork per corneal or scleral entry incision; and 3) the capital equipment costs are significant due to the energy-based cauterization and irrigation, which may limit adoption.

[0106] The methods (and systems and devices) described herein, including methods for providing disruption forces to trabecular canalicular tissue, may be well suited for Ab Intern's trabeculotomy and goniotomy, given that they avoid the use of electrocautery and are capable of advancing a conduit over a greater arc of Schlemm's canal. In some variations of the Ab Intern's 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 the conduit, which is slidable within the cannula and extendable from the cannula, sufficient to disrupt Schlemm's canal and surrounding tissue structures to reduce intraocular pressure. Another method that may be useful for treating an eye condition includes entering Schlemm's canal using a conduit extendable from a handle controlled by an operator, the handle comprising a fluid reservoir, and delivering a volume of viscoelastic fluid from the fluid reservoir through the conduit by increasing pressure in the fluid reservoir, the volume of viscoelastic fluid delivered being sufficient to disrupt Schlemm's canal and surrounding tissue structures to reduce intraocular pressure. The disruption volume may be between about 2 μl and about 16 μl. In one variation, the disruption volume is about 4 μl of viscoelastic fluid. As previously mentioned, in some examples, the disruption volume may range anywhere between about 20 μl and about 50 μl.

[0107] More specifically, disruption (e.g., cutting, breaking, removing, etc.) of the trabecular meshwork can be accomplished by removing the cannula from the eye while away from the canal in Schlemm's canal, thereby tearing through the trabecular meshwork. Alternatively, disruption of tissue can be accomplished by over-distending and purposefully viscous dilating 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 μl, or at least about 20 μl of viscoelastic fluid per 360 degree arc of Schlemm's canal. The size or extent of tissue disruption can be varied by the volume of fluid delivered. For example, 8 μl can be used to penetrate or slightly tear the trabecular meshwork, whereas 16 μl can be used to maximally tear the trabecular meshwork. 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.

[0108] Another method for disrupting tissue can include using an oversized conduit (e.g., having an outer diameter of 300-500 microns) to tear the trabecular meshwork upon delivery, or expanding or enlarging the conduit when fully advanced into Schlemm's canal with the goal of stretching, disrupting, tearing, or completely tearing the trabecular meshwork. For example, a catheter / conduit, probe, or wire (with or without a lumen) can be used that has a tip with an outer diameter of 200-250 microns but has a shaft that begins to flare outward to about 300 microns, about 400 microns, or about 500 microns after the 3 o'clock position of Schlemm's canal (i.e., at about the 5 mm to 10 mm mark of the catheter / conduit), so that when the tip is comfortably advanced within Schlemm's canal, the enlarged shaft trails and disrupts the trabecular meshwork as it is advanced.

[0109] Alternatively, tissue disruption may be accomplished by ab interno delivery of sutures throughout Schlemm's Canal, where the sutures are tensioned sufficiently to stretch Schlemm's Canal, disrupt the trabecular meshwork, and / or tear through the trabecular meshwork ("Ab interno Suture Trabeculotomy"). Here, a tool including gripping elements may be employed to pull the distal suture tips inward as the cannula is retracted from the eye, sever a full 360 degrees or a segment of the trabecular meshwork, or tie the suture ends together to provide tension to the trabecular meshwork without necessarily having to tear it.

[0110] Customizing the body segment of the conduit proximal to the tip with notches or barbs that capture the trabecular meshwork as the distal tip is guided and advanced along Schlemm's canal can also be utilized, thereby disrupting the trabecular meshwork, partially tearing the trabecular meshwork, completely tearing the trabecular meshwork, and / or removing the trabecular meshwork as it is advanced. Additionally, grafts with edges specifically designed to cut the trabecular meshwork can also be used. Yet another method for disrupting tissue can involve customizing the system (e.g., the conduit, any catheter or wire, the probe tip) to capture or grab the trabecular meshwork when retracted after being fully advanced through Schlemm's canal. This can be done using a wire having a curved tip, hooks, notches, or barbs at its end that is advanced through the lumen of the catheter to hook into the trabecular meshwork when retracted, thereby tearing or removing the meshwork along its length, or it can be done using only a metal or polymer wire or suture (without a catheter) that has a tip (and / or body) that is hooked, notched, or barbed so that it can be advanced into Schlemm's canal without tearing the trabecular meshwork, but that when retracted, will hook into the trabecular meshwork and / or remove it entirely. Referring to FIG. 30A, a cannula 1800 can be inserted into the anterior chamber 1802 and Schlemm's canal 1804, and a tool (e.g., a slidable conduit 1806) can be advanced within Schlemm's canal 1804. As shown in Fig. 30B, the cannula 1800 can be retracted from the anterior chamber 1802 without retracting the slidable conduit 1806. This action by itself can tear the trabecular meshwork. Alternatively, as shown in Fig. 30C, the conduit 1806 can be equipped with a disruption tool, such as, for example, an element 1808 with a sharp edge, that can cut or tear the trabecular meshwork while being retracted into the cannula 1800, which is held stationary.Exemplary elements having sharp edges can be hooks, wires, or any other suitable shape-memory components that can extend from the cannula to tear, cut, or remove the trabecular meshwork.

[0111] This configuration of the ocular delivery system can be advantageous in many different ways. For one, the delivery system can be used ab interno to implant an ocular device into Schlemm's canal or to deliver a fluid composition or tool into Schlemm's canal. For another, the delivery system cannula is configured to allow easy atraumatic access to Schlemm's canal. Furthermore, the delivery system is configured to give the surgeon more freedom of use, all in a single instrument. For example, the handle of the system is configured to be used with either the right or left hand for either the right or left eye by simply flipping the handle or rotating the cannula. Furthermore, the delivery system is designed to allow the right hand to be used to access Schlemm's canal in a counterclockwise direction, the left hand to access Schlemm's canal in a clockwise direction, or the left hand to access Schlemm's canal in a counterclockwise direction. Thus, access to Schlemm's canal from all four quadrants of the eye can be achieved. Additionally, the delivery system includes a single-handed, single-operator controlled device configured to provide sufficient force to disrupt Schlemm's canal and surrounding tissue to improve flow through the outflow pathway of the trabecular meshwork canaliculi. The system generally combines an access cannula, a delivery conduit, a conduit advancement mechanism, a disruption tool, and a viscoelastic fluid into a single device such that a conduit or tool can be advanced or fluid can be delivered by a single person or hand.

[0112] 31A and 31B generally illustrate top views of an embodiment of a cannula adapter 2100 in undeployed and deployed configurations, respectively. Cannula adapter 2100 includes a connector 2105, a housing 2110, an inner catheter 2115, and an outer cannula 2120.

[0113] The connector 2105 (e.g., a standard Luer connector) may be adapted to slide along a limited axial range within the housing 2110 of the cannula adapter 2100. The connector 2105 may further be limited in azimuthal rotation. The inner catheter 2115 may comprise a flexible lumen introduced through Schlemm's canal and 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 catheter 2120 such that the distal tip of the inner catheter 2115 and the distal tip of the outer cannula 2120 are aligned when the sliding connector 2105 is in a proximal-most position, such as the undeployed configuration shown in FIG. 31A.

[0114] The proximal end of the outer cannula 2120 can be coupled to a distal end portion of the housing 2110 (and the distal end of the housing's sliding channel 2122 within which the connector 2105 translates axially). When the connector 2105 is in its most distal position (such as the fully deployed configuration shown in FIG. 31B where the connector 2105 is pushed forward until the sliding channel 2122 in the housing 2110 terminates), the distal tip of the inner catheter 2115 can extend a predetermined distance past the distal tip of the outer cannula 2120. In some implementations, the predetermined distance can be approximately equal to the circumference of Schlemm's canal (e.g., 360 degrees). The length of the portion of the inner catheter 2115 that extends out of the distal tip of the outer cannula 2120 when the connector 2105 is in its distal-most position within the sliding channel 2122 of the housing 2110 can be configured to have a length corresponding to an upper limit (e.g., a known maximum) value or a length corresponding to an average or median value of the circumference of Schlemm's canal of a human or other mammal.

[0115] The distal portion of the inner catheter 2115 (e.g., including at least the portion extending past the distal tip) may be pre-shaped to move generally along the radius of curvature of Schlemm's canal (e.g., a predetermined median or average value) (e.g., using a shape memory material such as a copper-aluminum-nickel alloy or a nickel-titanium alloy to fix the shape) or may be made of a material sufficiently flexible to bend along the outer wall of Schlemm's canal (e.g., polyvinyl chloride, polyetheretherketone, polyethylene, polytetrafluoroethylene, thermoplastic polyurethane, polyamide, polyimide, polymethylmethacrylate (PMMA), acrylonitrile butadiene styrene, silicone, and / or other sufficiently flexible materials).

[0116] The cannula adapter 2100 of Figures 31A and 31B may be adapted for use with any standard "off the shelf" or commercially available ophthalmic viscosurgical device (OVD) or other viscoelastic delivery device, such as the HEALON Viscoelastic Syringe available from Johnson & Johnson. For example, a pre-filled ophthalmic viscoelastic device (e.g., syringe) 2125 may be inserted into the proximal end of the housing 2110 and rotated to tightly lock with the sliding connector 2105 as shown in Figure 31C. As an example of use, an operator (e.g., a clinician or medical practitioner) can use one hand to hold the housing 2110 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 a proximal stop 2127 of the syringe 2125) to extend the inner catheter 2115 out of the outer cannula 2120 (e.g., via translation of the sliding connector 2105), and then push the syringe 2125 in (e.g., by depressing a proximal plunger actuator 2128 of the syringe 2125, as shown in FIG. 31D) to deliver a desired amount of fluid 2126 (e.g., a viscoelastic fluid or other ophthalmic viscosurgical device (OVD) fluid). The desired amount can be patient-specific or location-specific and can be determined by the operator as desired and / or needed.

[0117] The outer cannula 2120 may be adapted to be inserted through a clear corneal incision that is minimally invasive and temporary. The corneal incision may be sized to self-seal without the need for sutures. FIG. 31E illustrates one exemplary method of surgical insertion using a superior insertion approach. As shown, the distal portion 2121 of the outer cannula 2120 may be shaped (e.g., a scoop with a sharpened tip) to facilitate penetration of the superior trabecular meshwork (TM) portion and to guide the inner catheter 2115 360 degrees to Schlemm's canal (SC) as shown in FIG. 31F. Alternatively, the distal tip of the outer cannula 2120 can be inserted using a transnasal insertion approach through the nasal trabecular meshwork, as shown in Figures 31G and 31H.

[0118] In some implementations, such as when using a transnasal insertion approach, the inner catheter 2115 may 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 may be inserted into Schlemm's canal through the trabecular meshwork to allow the inner catheter 2115 to be advanced through the first 180 degrees of Schlemm's canal from the insertion location into Schlemm's canal. The inner catheter 2115 may then be retracted and the distal tip 2121 of the outer cannula 2120 may be rotated or removed from Schlemm's canal and reinserted to allow the inner catheter 2115 to traverse the remaining 180 degrees of Schlemm's canal in the opposite direction from the entry point. The distal tip 2121 of the outer cannula 2120 may be pre-curved or may be flexible enough to bend when it contacts the outer wall of Schlemm's canal. If pre-curved, the distal tip of the outer cannula 2120 can have various curvature or bend configurations depending on whether a superior or nasal insertion approach is intended, in some implementations, only one 180 degree portion is treated.

[0119] Referring to FIG. 31I, a fluid control adapter 2130, according to multiple embodiments, can be attached to the proximal end of a syringe 2125 to facilitate precisely controlled delivery of viscoelastic or other fluids (e.g., drugs, chemicals, solutions, other liquids). In such implementations, the plunger handle of the syringe 2125 can be removed. In the embodiment shown, the fluid control adapter 2130 includes a dispenser attachment fitting 2132 adapted to attach to a syringe 2125, such as a typical pneumatic adhesive dispenser (such as a pneumatic dispenser commercially made by Nordson EFD). The attachment fitting 2132 can have a threaded throughbore for receiving a complementarily threaded "bolt-type" plunger driver 2133 and a rotatable knob 2134. Rotating the knob 2134 (and thus the plunger driver 2133) clockwise can push the internal plunger of the syringe 2125, thereby dispensing fluid 2126 (e.g., a viscoelastic fluid or other OVD fluid). The sensitivity of the delivery can be controlled by the pitch of the threads. The fluid control adapter 2130 can be rigidly connected to the syringe 2125, such that axial translation of the adapter 2130 (e.g., caused by axial translation of the knob 2134 from rotation of the knob 2134) can extend the inner catheter 2115. The rotatable knob 2134 can optionally be provided with a knurled head.

[0120] 32A and 32B, the cannula adapter 2200 may be adapted or modified to include a sliding trigger 2202 rigidly attached to the internal sliding connector 2105 (e.g., a single molded part during fabrication) and may be allowed to slide axially relative to the housing 2110. The operator may then simply extend the inner catheter 2115 via moving the operator's finger or thumb distally (i.e., toward the patient) instead of depressing the proximal stop of the syringe 2125 (e.g., depressing the proximal plunger actuator 2128 of the syringe 2125 as shown in FIG. 31D). The outer surface of the sliding trigger 2202 may have surface features (e.g., ridges, grooves, etc.) adapted to promote an operator's grip or friction against the operator's fingers or thumb.

[0121] Figure 32C illustrates a further modification or adaptation of the cannula adapter 2200 of Figures 32A and 32B adapted to enable actuation of the inner cannula 2115 and dispensing of viscoelastic or other fluids using one hand of an operator. The embodiment shown can include a sliding trigger 2202 as illustrated in Figures 2A and 2B for extending the inner catheter 2115, and further incorporates a pneumatic system 2210 adapted to pressurize the viscoelastic syringe 2125. The pneumatic system 2210 is enlarged and shown in more detail with respect to its components and operation in Figures 32D and 32E.

[0122] The pneumatic system 2210 can utilize a trigger 2212 adapted to be actuated by an operator's finger (e.g., index finger). FIG. 32D illustrates the pneumatic system 2210 before the trigger 2212 is depressed, and FIG. 32E illustrates the pneumatic system 2210 after the trigger is depressed (e.g., pushed away from the patient to compress the spring 2218). When the trigger 2212 is depressed (e.g., moved to its actuated position), a small valve-release pressurized cartridge 2216 (e.g., a PicoCylinder marketed by Picocyl) can be opened, thereby pressurizing a chamber 2214 that is fluidly coupled to the proximal side of a syringe plunger (e.g., using a fitting similar to a typical pneumatic adhesive dispenser). This arrangement or mechanism can advantageously allow for a steady, controlled dispensing of a pressurized source of fluid 2126 (e.g., a viscoelastic fluid or other OVD fluid) from a syringe 2125. When the trigger 2212 is released, the spring 2218 can relax to an uncompressed configuration, pushing the pressure cartridge 2216 back to its normal position and the chamber 2214 can be vented via the notch 2220, thereby snapping off the dispensing of, for example, a viscoelastic or other fluid. As shown in FIG. 32E, when the trigger 2212 is depressed, the valve 2222 of the pressure cartridge 2216 can be opened 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 stretched (e.g., moved back to its unactuated position).

[0123] The trigger 2212 can include a notch 2220 formed in a side of its 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 can create a path between the chamber 2214 and the surroundings. When the trigger 2212 is fully compressed and the cartridge 2216 opens and pressurizes the chamber 2214, the notch 2220 can be isolated from the surroundings, such that pressure within the chamber 2214 can be maintained. When the trigger 2212 is released and moves back to its unactuated position, the notch 2220 can create a path between the chamber 2214 and the surroundings, thereby venting the chamber 2214, thereby suddenly ceasing the dispensing of, for example, a viscoelastic fluid or other fluid as described herein.

[0124] 33A-33D show alternative embodiments of viscoelastic dispensing mechanisms incorporating valves and springs that may be incorporated into any of the embodiments described herein. FIG. 33A shows a cannula adapter 2300 that utilizes a compression spring 2304 to maintain force against a viscoelastic cartridge / plunger 2306. As described herein, actuation of the sliding trigger 2202 (e.g., sliding it toward the patient) may extend the catheter 2115 out of the distal end of the outer cannula 2120. In the example shown in FIG. 33A, the connector 2105 may include a dispense button 2302 and a valve 2308. The dispense button 2302 may have an inactivated position and an activated position. In the unactuated position (as shown in FIG. 33C ), the body of the dispense button 2302 can interrupt the flow path in the connector 2105, for example, preventing fluid 2126 from flowing from the viscoelastic cartridge 2306 into the catheter 2115. When in the actuated position (pressed downward to compress the spring 2310, as shown in FIG. 33D ), a lumen 2320 formed in the dispense button 2302 can connect to the flow path in the connector 2105 and between the viscoelastic cartridge 2306 and the catheter 2115. When the dispense button 2302 is released, the spring 2310 can bias the dispense button 2302 back to the unactuated position, interrupting the flow path between the viscoelastic cartridge 2306 and the catheter 2115.

[0125] In some implementations, as shown in FIG. 33A, the viscoelastic cartridge 2306 includes an optional diaphragm 2330, and the connector 2105 (e.g., a Luer connector as shown in FIG. 31A) can include a hypodermic needle 2312 for piercing the diaphragm 2330.

[0126] The viscoelastic cartridge 2306 may be housed within a single slide assembly (as shown in FIG. 33A) or may have a separate fitting with a plunger spring 2304 (as shown in FIGS. 33B-33D). Referring to FIGS. 33B-33D, which better illustrate the operation of the viscoelastic dispensing mechanism, the thumb slider / trigger 2202 may be used to actuate the inner catheter 2115 into and out of Schlemm's Canal (as shown in FIGS. 33C and 33D), while the dispense button 2302 is used to dispense fluid 2126 (e.g., viscoelastic fluid or other OVD fluid) from the viscoelastic cartridge 2306 (as shown in FIG. 33D).

[0127] According to various embodiments, the cannula adapters shown and described herein may be configured with multiple sliding layers, as shown generally in Figures 34A-34C. The multiple sliding layers may include three layers: a needle assembly 2420 with a sharp distal tip designed to penetrate the cornea; a cannula assembly 2440 with a tip designed to traverse the anterior chamber and penetrate the trabecular meshwork; and an inner catheter assembly 2460 with a blunt or rounded distal tip designed to traverse Schlemm's canal and lumen for the purpose of delivering viscoelastic or other fluids. Figure 34A shows the needle assembly 2420 of the cannula adapter 2400 (as shown in Figure 34E), Figure 34B shows the cannula assembly 2440, and Figure 34C shows the inner catheter assembly 2460.

[0128] The needle assembly 2420 and the cannula assembly 2440 may include slots as shown. The needle assembly 2420 may include a body 2422, a lumen 2424, an upper slot 2426, a lower slot 2428, and a needle 2430. The needle 2430 may be integral with the body 2422. The slots 2426, 2428 may be formed on opposite sides of the body 2422. In some implementations, the location of the slots 2426, 2428 may differ from the example shown in FIG. 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 integral with the body 2442 such that movement of the cannula slider 2448 may translate to 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 integral with the body 2462 such that movement of the catheter slider 2464 may translate to movement of the body 2462 and the catheter 2115.

[0129] The operation and assembly arrangement of the three sliding layers of cannula adapter 2400 is shown generally in Figures 34E-34G. Cannula assembly 2440 may be disposed 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 disposed within lower slot 2428 of needle assembly 2420. Catheter assembly 2460 may be disposed within cannula assembly 2440 such that catheter slider 2464 is disposed within upper slots 2426, 2446 of needle assembly 2420 and cannula assembly 2440, respectively.

[0130] The needle 2430 can penetrate the patient's cornea as described herein. A cannula slider 2448 can slide within a slot 2428 of the needle assembly 2420 to allow the cannula assembly 2440 to slide within the needle assembly 2420. When the cannula slider 2448 is moved distally (e.g., toward the patient), a tip 2450 of the cannula assembly 2440 can move distally, e.g., to penetrate an upper trabecular meshwork (TM) portion of the patient. The slot 2446 of the cannula assembly 2440 can overlap at least a portion of the slot 2426 of the needle assembly 2420, thereby allowing the catheter slider 2464 to slide distally (e.g., toward the patient) and proximally (e.g., away from the patient) within the slots 2426, 2446. When the catheter slider 2444 is moved distally (e.g., toward the patient), the catheter 2115 can exit, e.g., through the distal end of the tip 2450, and can enter, e.g., Schlemm's canal and move along, e.g., Schlemm's canal. FIG. 34D shows an enlarged side view of the distal tip of the catheter 2115. As shown in FIG. 34D, the catheter 2115 can include a rounded tip 2452 and a lumen 2454 that allows a viscoelastic or other fluid to flow therethrough.

[0131] The three sliding layer assemblies shown and described in FIGS. 34A-34G can advantageously eliminate the need for multiple separate surgical instruments, thereby simplifying the procedure.

[0132] 35A-35B show the internal components of various embodiments of the cannula adapters described herein. An obvious challenge with a large catheter reach is preventing internal buckling as the inner catheter 2115 is fed through the outer cannula 2120. FIGS. 35A-38B show various internal support mechanisms (which may be used separately or one or more mechanisms may be combined together) designed to prevent buckling and to guide the inner catheter 2115 along the outer cannula 2120.

[0133] 35A and 35B show side views of cannula adapter 2500 (in undeployed and fully deployed configurations, respectively) including a collapsible helical support 2152 having an inner diameter slightly larger than inner catheter 2115 and an outer diameter confined by housing 2110. Helical support 2152 can have a spring force close to zero and still maintain radial stability.

[0134] 36A and 36B show side views of a cannula adapter 2600 including a rigid support tube 2154 having an inner diameter sized to fit within the inner catheter 2115 and an outer diameter sized to slide within the outer cannula 2120 (in an undeployed and fully deployed configuration, respectively). The rigid support tube 2154 may be formed of any suitable rigid material, such as 300 series stainless steel. In some implementations, the rigid support tube 2154 may be used to increase the diameter of the outer cannula 2120.

[0135] 37A and 37B show side views of a cannula adapter 2700 including a wheel 2701 and a catheter feeder 2702, 2704. The catheter feeder 2702, 2704 can stabilize the catheter 2115 as it moves distally (e.g., toward the patient) or proximally (e.g., away from the patient) and can prevent the catheter 2115 from bending. The wheel 2701 can be coupled to the catheter feeder 2702 such that rotation of the wheel 2701 can be translated into rotation of the catheter feeder 2702. For example, as shown in FIG. 37B, a counterclockwise rotation of the wheel 2701 can rotate the catheter feeder 2702 in a clockwise direction. A clockwise rotation of the catheter feeder 2702 can traverse the catheter 2115 distally (e.g., toward the patient). Similarly, clockwise rotation of the wheel 2701 can rotate the catheter feeding device 2702 in a counterclockwise direction, thereby causing the catheter 2115 to traverse proximally (e.g., away from the patient). In some implementations, the catheter feeding devices 2702, 2704 are coupled to one another such that rotation of one rotates the other. For example, clockwise rotation of the catheter feeding device 2702 can rotate the catheter feeding device 2704 in a counterclockwise direction (as shown in FIG. 37B). In some implementations, movement of the catheter 2115 (e.g., distal or proximal) can rotate the catheter feeding device 2704. In some implementations, the catheter 2115 can be retracted by simply pulling the assembly away from the syringe 2125 (e.g., instead of rotating the wheel 2701 in a clockwise direction).

[0136] 38A and 38B show side views of a telescopic tube 2800 that can support the catheter 2115 when collapsed during actuation (e.g., in an undeployed configuration and a fully deployed configuration, respectively), and the telescopic tube 2800 may be incorporated into any of the embodiments of the cannula adapter or fluid (e.g., viscoelastic) delivery device described or shown herein.

[0137] 39A-39F show a feeding mechanism 2900 that can be used to feed the catheter 2115 into the outer cannula 2120. The feeding mechanism 2900 can be incorporated into any of the cannula adapter embodiments described or shown herein. The feeding mechanism 2900 can include a thumb control dial 2901 located near the distal end of the housing 2110 to facilitate one-handed operation by an operator.

[0138] The dial 2901 may be rotated by the operator's thumb through interaction with a protrusion or projection 2904 extending upwardly from the dial 2901. Alternatively, the protrusion or projection 2904 may include an indentation or notch. The dial 2901 may be operatively coupled to a proximal end of the inner catheter 2115 such that rotation of the dial 2901 in, for example, a clockwise direction advances the inner catheter 2115 in a controlled manner along the outer cannula 2120 and out of the outer cannula 2120 and along and into Schlemm's canal, and rotation of the dial 2901 in, for example, a counterclockwise direction retracts the inner catheter 2115. Of course, these directions may be reversed if desired and / or required. A distal portion of the inner catheter 2115 adapted to extend out of the distal tip (e.g., inner loop) of the outer cannula 2120 upon a full rotation of the dial 2901 can have a length adapted to fit or correspond (e.g., approximately equal) to the entire 360 ​​degree circumference of Schlemm's canal, as described herein. In some implementations, a 360 degree rotation of the dial 2901 corresponds to a 360 degree movement of the catheter 115 along Schlemm's canal (as shown in FIGS. 39B and 39D). Additionally, the distal portion of the inner catheter 2115 can include a preformed structure (e.g., a shape-fixed material having a predetermined radius of curvature corresponding to the radius of curvature of Schlemm's canal) or a flexible material structure, as described herein.

[0139] The dial 2901 can include a button 2902 that can be depressed by an operator's thumb. The button 2902 can be actuated (e.g., moved from an inactivated position to an activated position) to cause dispensing of a viscoelastic fluid or other viscous surgical fluid. For example, the button 2902 can be actuated to cause (e.g., actuate) a control valve to dispense a viscoelastic fluid or other viscous surgical fluid. The dispensing of the viscoelastic fluid or other viscous surgical fluid can occur at a constant rate, or at a variable rate based on the magnitude of depression of the button 2902, or at a predetermined bolus dose per button press. In some implementations, actuation of the button 2902 can actuate a pump, such as a positive displacement pump.

[0140] In some implementations, the delivery mechanism 2900 can include indentations or detents located at the time markings around the dial 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 imaging means. For example, the detents at each time mark can provide tactile feedback to the operator (e.g., false stops) or can generate an audible click to provide auditory feedback to the operator. The operator can stop at a given time mark, dispense a given volume of the viscoelastic or other fluid, and then move on to the next time mark.

[0141] The catheter 2115 may be made of one or more bonded materials, such as nylon / Pebax® polymer, polyimide, etc. The distal end of the catheter 2115 may be overmolded (e.g., insert molded) into the dial mechanism or may be bonded (e.g., via adhesive) to the dial mechanism. The transport path for feeding the catheter 2115 into the outer cannula 2120 may be a separate molded or metal component or may be formed within the housing 2110 of the cannula adapter 2100. FIGS. 39E and 39F show examples of how the dial 2901 may be incorporated into or assembled with the housing 2110. The inner catheter 2115 may be connected to a fluid delivery system (not shown), such as a valve or syringe (such as the valves or syringes described herein), via a separate section of tubing 2906 fluidly coupled to the catheter 2115 (as shown in FIGS. 39E and 39F) or via channels formed in a molded component. In some configurations, the valve may be integrated directly into the dial mechanism.

[0142] The cannula adapters described and illustrated herein can incorporate a wide variety of viscoelastic dispensing mechanisms or systems. FIGS. 40A-40C show an example of a delivery system 3050 in conjunction with the cannula adapter (feeding mechanism 2900) of FIGS. 39A-39F. The delivery system 3050 can 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., by friction fit, corresponding mating structures, latches, notches, etc.) to the housing 2110 of the cannula adapter (feeding mechanism 2900). The reservoir 3001 can include a spring 3002 that can be retracted to a compressed position (or configuration) prior to use, as shown in FIG. 40A. A stop 3006 (e.g., a rubber stop) may be located in or near the proximal end of the reservoir 3001 (e.g., the end opposite the feeding mechanism 2900). A connector 3004 (e.g., a female luer connector) may be located at the distal end of the reservoir 3001 (e.g., the end closer to the feeding 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 implementations (not shown), there may be a septum at the distal end of the reservoir 3001 that can be pierced with a needle or dispensing cannula.

[0143] The reservoir 3001 may be filled with fluid 2126 (e.g., viscoelastic fluid or other ophthalmic viscosurgical device (OVD) fluid) by depressing the plunger of a standard viscoelastic syringe 2125. Once the reservoir 3001 is filled, the stop 3006 may be pushed back against the compression spring 3002. A bleed valve or a breathable material such as a porous plastic or polymeric material may be integrated into the reservoir 3001 to allow for additional purging of air during filling. Once the desired amount of fluid 2126 (e.g., viscoelastic fluid or other fluid) has been added to the reservoir 3001, a delivery system 3050 may be connected to the housing 2110, which contains the catheter 2115. Once the delivery system 3050 is connected to the housing 2110, the base member 3008 may be rotated, thereby releasing the spring 3002 and applying a force against the stop 3006. The spring 3002 can be operatively coupled to the base member 3008 to facilitate engagement (e.g., compression and relaxation) of the spring 3002 upon actuation of the base member 3008. In some implementations, rotation of the base member 3008 can compress or relax the spring 3002. According to various embodiments, the delivery system 3050 of FIGS. 40A-40C can advantageously accommodate any selection of viscoelastic or other fluids and various amounts of viscoelastic or other fluids. The delivery system 3050 can ensure that a constant spring force is applied to the reservoir 3001 upon filling.

[0144] 41A and 41B, a fillable cannula adapter 3100 is disclosed herein. The embodiment of the cannula adapter 3100 shown in FIGS. 41A and 41B utilizes a screw drive system (or threaded plunger system) that may be incorporated into the housing 2110 of the cannula adapter 3100 or the housing of other embodiments of the cannula adapters described herein. The cannula adapter 3100 may 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 may be filled (e.g., primed) with fluid 2126 from a syringe 2125 (e.g., a standard viscoelastic syringe), and a cap or other closure may be placed on the rear end of the reservoir 3101 prior to operation. The wheel 3110 can be located and arranged to make the wheel 3110 accessible via a slot formed in the abdominal (e.g., bottom or underside) of the housing 2110. The wheel 3110 can be conveniently arranged to be rotated by an operator's index or middle finger when the housing 2110 is held in the operator's hand with the thumb resting on the dial 2900. The threaded plunger 3112 can be operatively mechanically coupled to the wheel 3110 such that rotation of the wheel 3110 will actuate the threaded plunger 3112. The threaded plunger 3112 and the wheel 3110 can include lumens fluidly coupled to tubing (e.g., flexible silicone tubing), which is further fluidly coupled to a lumen of the catheter 2115. In some implementations, the lumen of the threaded plunger 3112 can be directly coupled to the lumen of the catheter 2115 without any intervening tubing. When the threaded plunger 3112 presses against the reservoir 3101 , fluid 2116 (eg, a viscoelastic fluid or other ophthalmic viscosurgical device (OVD) fluid) is dispensed in a reverse direction through the plunger 3112 towards the catheter 2115 .

[0145] Although the fluid delivery system shown in Figures 41A and 41B is coupled to the feed mechanism 2900 described and shown in connection with Figures 39A-93F, the fluid delivery system of Figures 41A and 41B can theoretically function with any suitable feed system embodiment. According to several embodiments, the catheter 2115 can be moved (e.g., via the feed mechanism 2900) independently of the threaded plunger 3112, thereby allowing an operator to dispense fluid at any time. This independent movement capability can be implemented by loosely connecting the plunger tube (e.g., a tube extending through the lumen of the wheel 3110 and the plunger 3112) to the catheter 2115 via flexible tubing (e.g., silicone tubing). The connection between the plunger tube and the catheter 2115 can alternatively be achieved using Pebax® polymer tubing or other more durable tubing, or using rigid tubing shaped like a spring to allow independent movement of the catheter 2115.

[0146] The connector 3104 (e.g., a female connector) can allow the operator to fill the reservoir 3101 with any standard viscoelastic syringe 2125, as in the delivery system 3050 shown in Figs. 40A-40C. The reservoir 3101 and the entire downstream system can be primed with the syringe 2125. The reservoir 3101 and the stop 3106 (e.g., a rubber stop) can be shaped to simplify the filling procedure and prevent undesired air trapping. 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 remainder of the handle for ergonomics. The cap 3105 can further have an extension that protrudes into the reservoir 3101 to purge any last traces of air from the connection when attached. Alternatively, the device can include a valve that can be closed when priming is complete.

[0147] The wheel 3110 of the housing 2110 (e.g., exposed at the ventral portion of the housing 2110) can include detents to provide an indication of the volume dispensed. For example, the detents can produce an audible clicking noise or tactile feedback at each incremental volume. The detents can be user customizable, so that an operator can choose to have a click every 2 μL or every 5 μL, for example. Of course, other volume indications can be used as desired and / or required. In some embodiments, the ventral portion (or lower surface) of the housing 2110 can include a plurality of spaced apart linear indicators that indicate the total volume dispensed so far or the residual volume remaining in the reservoir (e.g., reservoir 3101). This mechanism can be driven by a screw coupled with a coarser pitch to amplify the linear motion or can be driven on a gear-pinion system, for example.

[0148] According to various embodiments, the cannula adapter 3100 shown in Figures 41A and 41B can advantageously include a fluid delivery system configured for one-handed use that is familiar to an operator. The fluid delivery system further allows for dispensing of viscoelastic or other fluids at any time rather than being tied to the movement of the inner catheter, thereby allowing the operator to navigate through barriers or obstructions encountered or contacted by the inner catheter during traversal along Schlemm's canal.

[0149] 42A-42B show an example of a delivery system 3250 that may be incorporated into the cannula adapter described herein. The delivery system 3250 may advantageously allow for controlled dispensing of a microbolus dose. The delivery system 3250 may include an elastic tube (e.g., a compliant tube) 3210 that is filled by closing a distal end 3214 of the tube 3210 and opening a proximal end 3212 of the tube 3210 to a pressurized (spring-loaded) reservoir 3200. The reservoir 3200 may include a spring 3202 and a stop 3204 having similar structural and operational features as the delivery system 3050 described in connection with FIGS. 40A-40C. After filling the tube 3210 as shown in FIG. 42A, an operator may flip a switch (not shown) to close the proximal end 3212 and open the distal end 3214 to expel the elastic tube 3210 through the catheter 2115. The length, diameter, and durometer of the elastic tube 3210 can be varied to achieve a desired bolus dose volume.

[0150] Opening and closing the proximal end 3212 and the distal end 3214 may be aided by moving the block 3220 between different positions by a control device. For example, the block 3220 may have a first position (shown in FIG. 42A ) and a second position (shown in FIG. 42B ). When the block 3220 is in the first position, a first opening 3222 of the block 3220 may be fluidly connected to the proximal end 3212 of the tube 3210 and the reservoir 3200, whereas a second opening 3224 may be offset from the distal end 3214 to fluidly disconnect the distal end 3212 and the catheter 2115. Thus, when the block 3220 is in the first position, a fluid 2126 (e.g., a viscoelastic fluid or other ophthalmic viscosurgical device (OVD) fluid) stored in the reservoir 3200 can enter the tube 3210 via the proximal end 3212 and fill the tube 3210 up 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, whereas the second opening 3224 can fluidly connect the distal end 3214 and the catheter 2115. Thus, when the block is in the second position, a fluid stored in the tube 3200 (e.g., between the proximal end 3212 and the distal end 3214) can be drained into the catheter 2115 via the second opening 3224.

[0151] 43A-43C show an example of a peristaltic fluid delivery system 3300. The peristaltic fluid delivery system 3300 can include a resilient tube (or compliant tube) 3320 and a peristaltic pump 3310 (shown in FIGS. 43B and 43C) that includes protrusions 3350 (e.g., rollers or rolling bearings) adapted to sequentially compress or squeeze the tube 3320 at spaced locations along the length of the tube 3320 to convey liquid between a fluid reservoir 3300 storing fluid 2126 and the catheter 2115. At least a portion of the tube 3320 and the protrusions 3350 can be encased within a circular pump casing 3360. The peristaltic pump 3310 can be a rotary peristaltic pump (as shown) or a linear peristaltic pump.

[0152] In the embodiment shown, the tube 3320 may be disposed within the pump casing 3360 around a protrusion 3350 (e.g., a rolling bearing) on ​​the rotor 3352. The pump casing 3360 may be actuated (e.g., pushed toward the rotor 3352) to press (e.g., compress) at least a portion of the tube 3320 with the protrusion 3350. While the pump casing 3360 is actuated, the rotation of the rotor 3352 forces the fluid 2126 downstream along the tube 3320. When each of the pump elements 3350 disengages from the tube 3320, fluid flow is induced into their respective portions of the tube 3320. FIGS. 43B and 43C show cross-sectional views of the peristaltic pump 3310. The peristaltic fluid delivery system 3300 may be primed (e.g., to allow fluid 2126 to enter the tube 3320) prior to engaging the tube 3320 with the pump element 3350. In some examples, the pump 3310 may be actuated by rotating the rotor 3352 after priming.

[0153] FIG. 44 illustrates various concepts related to catheter shapes and structures to facilitate visualization and tracking of the catheter 2115 as it is advanced along Schlemm's canal. A key challenge in viscous or other fluid delivery procedures is locating the tip of the inner catheter so that it does not migrate into undesirable anatomy (such as the suprachoroidal space when targeting Schlemm's canal). The topmost diagram illustrates a standard catheter lumen. The second diagram from the top illustrates that the distal end of the inner catheter can include a bulbous tip. The bulbous tip can be achieved by overmolding material onto the extruded lumen. Referring to the third diagram in the middle, the catheter itself (e.g., catheter 2115) can be formed using a polymer with phosphorescent pigments, so that the catheter can be filled with a microscope light or ultraviolet / blue light source and glow when the light is dimmed. Alternatively, the operator may have a UV / blue light source attached to the surgical microscope that may be turned on during the procedure to allow a better view of the phosphorescent catheter. In the embodiment shown in the fourth figure (second from the bottom), the catheter includes a bulbous distal tip that is colored with a phosphorescent pigment (e.g., a glow in the dark material such as strontium aluminate). The bulbous tip may be overmolded onto the distal end of the extruded lumen. The last figure at the bottom shows that the catheter 2115 may include contrast marks 3400 spaced along the length of the inner catheter to facilitate visualization of the inner catheter (e.g., to more clearly show the portion of the inner catheter that is viewed through the trabecular meshwork). The distal tip may also include a more extensive (e.g., longer or wider) contrast mark to show the distal tip of the inner catheter. The cannula adapters described herein may be designed to be used without a fiber optic cable to reduce cost.

[0154] 45A and 45B show a schematic of the operation of an outer cannula 3500 that utilizes a shape memory material (e.g., Nitinol or other shape memory alloy material) to form a shape-fixed distal tip 3520. The cannula's distal tip 3520 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 is curved and shape-fixed when unconstrained (e.g., by the introducer needle). This shape-fixed configuration allows the outer cannula 3500 to slide within the rigid introducer needle 3510, but allows the outer cannula 3500 to curve and enter Schlemm's canal when slid forward out of the introducer needle 3510.

[0155] FIG. 46 shows an example of a distal end portion (e.g., distal tip) of the outer cannula 2120. As shown, the distal end portion (e.g., distal tip) can include a notch 3600 in the tubing to allow the cannula 2100 to be articulated in a particular orientation. In some implementations, the distal end portion (e.g., distal tip) is connected to a pull wire, allowing an operator to control articulation of the cannula 2120 near the notched distal tip. In some implementations, the tip of the outer cannula 2120 can be configured to seat or anchor at the posterior wall of Schlemm's canal to prevent erroneous movement of the tip, for example, during a viscous or other fluid delivery procedure.

[0156] 47A-47H, an embodiment of a cannula adapter or fluid delivery device 3700 is disclosed. The cannula adapter 3700 can 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 stop 3790, and a distal end 3706 having two portions 3706A, 3706B. The distal end 3706 can include an opening sized to receive the cannula 2120. The first slider 3702 can be mechanically and / or operably coupled to the reservoir 3780 and the plunger 3712. The second slider 3704 can include an insert 3704, which can be formed, for example, on an underside of the second slider 3704.

[0157] The fluid delivery conduit 3716 can include a proximal base 3709, a body 3708, and a tube 3714. The fluid delivery conduit 3716 can be disposed within the insert 3740 of the second slider 3704 (as shown in FIG. 47H). In some implementations, at least a portion of the body 3708 and the base 3709 are disposed within the insert 3740 of the second slider 3704. The tube 3714 of the fluid delivery conduit 3716 can be operably 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 implementations, the tube 3714 is directly connected to the catheter 2115. In some implementations, the tube 3714 is indirectly connected to the catheter 2115 via an intervening tube. The tube 3714 is fluidly connected to the catheter 2115 .

[0158] The fluid delivery conduit 3716 can allow for the flow of fluid (e.g., a viscoelastic fluid) from the reservoir 3780 to the catheter 2115. As shown in FIGS. 47D and 47E , the body 3708 of the fluid delivery conduit 3716 can include a bore 3720 that can receive a plunger 3712, which can slide within the bore 3720 of the body 3708. The plunger 3712 can include a lumen 3722 that can allow for the flow of fluid (e.g., a viscoelastic fluid) through the plunger 3712, into the bore 3720 of the fluid delivery conduit 3716, and through the tube 3714 toward the catheter 2115.

[0159] During operation, the first slider 3702 and the second slider 3704 can move distally (e.g., toward the distal end 3706) along the channel 3703 in unison. As described herein, distal movement of the second slider 3704 can move the fluid delivery conduit 3716 distally (e.g., toward the distal end 3706), which can further move the catheter 2115 distally out of the cannula 2120. With reference to the example shown in FIG. 1F, an operator can penetrate the distal portion 2121 of the cannula 2120 into the upper trabecular meshwork (TM) portion 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).

[0160] Once the catheter 2115 is extended out of the cannula 2120 (e.g., guided into Schlemm's canal (SC)), the first slider 3702 may be used to dispense a fluid (e.g., a viscoelastic fluid) stored in the reservoir 3780. To dispense a fluid stored in the reservoir 3780, the first slider 3702 may be moved proximally along the channel 3703 (e.g., away from the distal end 3706) and then moved distally along the channel 3703 relative to the second slider 3704 (e.g., toward the distal end 3706). In some implementations, the second slider 3704 remains stationary (e.g., to ensure that the catheter 2115 does not move) while the first slider 3702 is moved along the channel 3703 to dispense a fluid (e.g., fluid 2126) stored in the reservoir 3780. When the first slider 3702 is moved proximally along the channel 3703 relative to the second slider 3704, the plunger 3712 can move proximally within the bore 3720 of the body 3708 of the fluid delivery conduit 3716. Proximal movement of the plunger 3712 (e.g., relative to the fluid delivery conduit 3716) within the bore 3720 can flow fluid stored in the reservoir 3780 past the ball 3730 and gasket 3731 and into the lumen 3722 of the plunger 3712 and into the bore 3720 of the fluid delivery conduit 3716. Once the fluid has flowed into the bore 3720 of the fluid delivery conduit 3716, the plunger 3712 can move distally along the channel 3703, thereby forcing the fluid out of the bore 3720 and into the tube 3714. In some implementations, the ball 3730 (and gasket 3731 ) can restrict the amount of fluid flowing from the reservoir 3780 into the lumen 3722 of the plunger 3712 .

[0161] In some implementations, an operator (e.g., a clinician, surgeon, healthcare provider) can vary the amount of fluid dispensed by varying the distance the first slider 3702 is moved along the channel 3703. For example, the more the first slider 3702 is moved proximally (e.g., toward the operator) along the channel 3703, the more fluid will be dispensed through the catheter 2115, and vice versa. In some implementations, the channel 3703 (or the first slider 3702) can include a detent that can provide tactile feedback regarding the distance of proximal (e.g., toward the operator) movement of the first slider 3702 along the channel 3703 to indicate the amount of fluid that will be dispensed when the first slider 3702 is moved distally in the opposite direction along the channel 3703.

[0162] The ball 3730 and gasket 3731 can function together as a check valve for the plunger 3712. The ball 3730 and gasket 3731 can allow for dispensing of fluid (e.g., fluid 2126) from the reservoir 3780 while preventing the fluid (e.g., fluid 2126) from flowing backwards (e.g., toward the reservoir 3780) through the ball 3730 and gasket 3731. Thus, once fluid flows through the ball 3730 and gasket 3731, the fluid cannot flow back into the reservoir 3780. In some implementations, other types of suitable valves can be used to provide a one-way flow of fluid (e.g., fluid 2126) out of the reservoir 3780 and through the plunger 3712.

[0163] In some implementations, a user may experience more resistance when sliding the second slider 3704 back and forth to dispense fluid from the reservoir 3780 compared to sliding the first slider 3702 both back and forth to move the catheter 2115 out of the cannula 2120. The resistance may be caused by greater friction between the second slider 3704 and the first slider 3702 (and channel 3703) than between the first slider 3702 and the channel 3703. This difference in resistance may provide tactile feedback that allows a user to distinguish, for example, between a catheter dispensing motion (e.g., sliding the first slider 3702) and a fluid dispensing motion (e.g., sliding the second slider 3704).

[0164] In some implementations, the second slider 3704 can include a groove 3705 within which the first slider 3702 can move (e.g., slide) distally or proximally. The first slider 3702 and the second slider 3704 can include ridges 3752 and grooves 3750 that can provide a good grip for an operator (e.g., a healthcare provider).

[0165] In some embodiments, the cannula 2120 can include a protrusion 3755 that can fixedly attach the cannula 2120 to an insert formed inside the distal end 3706 (as shown in the example shown in FIG. 47F). Thus, the distal end 3706 can be rotated to change the orientation of the cannula 2120 and thus 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 (e.g., by rotating about an axis parallel to the length of the cannula adapter) without having to change the orientation of the cannula adapter 3700.

[0166] The cannula adapter 3700 can include a stop 3790 that can be positioned within the channel 3703. The stop 3790 can prevent distal movement of the first slider 3702 and the second slider 3704, for example, during storage or during operation. This can advantageously prevent the catheter 2115 from accidentally or inadvertently extending out of the cannula 2120.

[0167] 47E, a gasket 3710 can be disposed within the base 3709 of the fluid delivery conduit 3716. The gasket 3710 can be sized to fit snugly within the base 3709 and can include an opening (e.g., a circular opening) for receiving the plunger 3712. In some implementations, the gasket 3710 can contact an outer surface of the plunger 3712 to generate sufficient resistance to cause smooth, controlled movement of the plunger 3712 within the bore 3720 of the body 3708.

[0168] 48A-48D show various views of the cannula 2120 and catheter 2115. As described herein, the cannula 2120 can include a tip 3800 and a distal portion 2121 that allows for penetration of the upper trabecular meshwork (TM) portion with an end face 3804. The end face 3804 can be formed at an angle (e.g., sloped) relative to an axis parallel to the body of the cannula 2120. The end face 3804 can, for example, facilitate penetration of the upper trabecular meshwork (TM) portion. In some implementations, the end face 3804 can be perpendicular (or substantially perpendicular) to an axis parallel to the body of the cannula 2120. The tip 3800 can form a beveled distal tip to aid in cutting. The distal portion 2121 may be curved to allow the catheter 2115 to extend (e.g., exit) out of the lumen 3802 of the cannula 2120 at an angle, which may facilitate movement of the catheter 2115 into and around Schlemm's Canal (SC). The catheter 2115 may include a distal end 3810 (e.g., tip) having a tapered edge 3812. The tapered edge 3812 may facilitate and guide movement of the catheter 2115 within the curved distal portion 2121 and within Schlemm's Canal (SC).

[0169] 48E-48H show another example of a distal portion 2121 of the cannula 2120. The distal portion 2121 can include one or more notches 3852 that can be formed at the tip 3800 of the distal portion 2121 to provide one or more cutting edges or surfaces. In some implementations, the notches 3852 can be formed on a distal edge of the distal portion 2121 (e.g., an edge of the distal portion 2121 that is further from the proximal portion of the cannula 2120). In some implementations with multiple notches 3852, the notches 3852 can be formed adjacent to one another (e.g., as shown in FIGS. 48G and 48H). The cutout 3825 can include an anchor 3854 that can abut a surface (e.g., the posterior wall of Schlemm's canal) during dispensing of fluid through a catheter (e.g., catheter 2115) and stabilize the cannula 2120 (e.g., prevent the distal portion 2121 of the cannula 2120 from moving thereabout). In some implementations, the anchor 3854 can penetrate a tissue surface (e.g., the posterior wall of Schlemm's canal) during use. The distal portion 2121 described herein and shown in FIGS. 48E-48H can be incorporated into any implementation of the cannula 2120 described herein.

[0170] 49A and 49B show an example operation scheme of the cannula adapter 3900. The cannula adapter 3900 can include a slider 2202, a cannula 2120, a dispensing mechanism 3902, and a reservoir 3904. An operator can slide the slider 2202 distally (e.g., toward the patient), for example, to guide a catheter out of the cannula 2120 and into Schlemm's canal. The operator can then actuate the reservoir 3904 to dispense fluid into and out of the catheter 2115. In some implementations, the dispensing mechanism 3902 can include a fixed plunger disposed within the reservoir 3904 for pushing 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 implementations, the dispensing mechanism 3902 can include a plunger disposed within the reservoir 3904 and connected to a resilient member (e.g., a spring) that can push fluid out of the reservoir 3904 and toward the catheter 2115, for example, when the proximal end of the reservoir 3904 is pushed distally (e.g., toward the patient).

[0171] According to several implementations, trypan blue or some other biocompatible dye (e.g., brilliant blue, indocyanine green, fluorescein) is placed in the reservoir 2164 prior to filling. The introduction of the biocompatible dye may allow the operator to visualize the degree of dilation within Schlemm's canal and downstream within the episcleral venous network.

[0172] Several additional features can be integrated into the above concept. For example, a wound sealing structure on the outside of the outer cannula 2120 or introducer needle, such as an overmolded compliant material / elastomer or an O-ring that fits into or is pressed against the corneal incision during surgery, would prevent leakage of aqueous humor. Alternatively, a balanced salt solution (BSS) injection path through the outer cannula 2120 could be used to provide stability to the anterior chamber.

[0173] Although primarily described with respect to delivery of viscoelastics within Schlemm's canal, the devices and methods illustrated herein may also be used in connection with delivery of viscoelastic or other fluids to other existing or created anatomical passageways, channels, spaces, lumens, or vessels, all of which are associated with the eye (e.g., return tracts, downstream episcleral venous networks, ocular tissue tracts, suprachoroidal space, subconjunctival space, subretinal space), or those located elsewhere outside of the eye. Fluids other than viscoelastics may also be used (e.g., other liquid agents, drugs, solutions, chemicals, etc.).

[0174] In an aspect of the present disclosure, an ophthalmic viscosurgical device (OVD) may be connected to the device through a tube in a nurse-activated delivery.

[0175] In an embodiment of the present disclosure, the OVD may be provided as a pen-cap OVD for viscoelastic solutions used in eye surgery. For example, an integrated handle has a fluid reservoir located entirely within it. As another example, the OVD may be prepackaged in an attachable (e.g., claw-attached) device, where the device may be attached to the handle by the claw or connected via a needle. Another claw-attached OVD device may be connected via a needleless connector using a duckbill valve, spiked valve, or maxplus valve. In some examples, the OVD may be loaded into a cartridge in the operating room, and then the cartridge may be attached to the device by the claw.

[0176] In aspects of the present disclosure, an ophthalmic device (e.g., cannula adapter 3900, ophthalmic device 4000) may be provided where 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 woven (e.g., like a cardiac stent). Here, the much more distal end 3810 may be holeless, or may have holes 2123a (see FIG. 50) sized to allow pressure to be generated within the catheter 2115 such that the viscoelastic solution flows through the wall of the catheter 2115 and generates pressure around the catheter 2115 (e.g., generating pressure within Schlemm's canal, expanding the trabecular meshwork, and expanding the return tract).

[0177] In an embodiment of the disclosure, the O-ring 2124 can create a zone of confining fluid (e.g., generate a localized pressure) as shown in FIG. 51. In an embodiment of the disclosure, a sinusoidal outer diameter can be used instead of or in addition to the O-ring 2124. As shown in the top view of FIG. 51, the OVD 2129 is located to the side of the tip 3810 of the catheter 2115, and the viscoelastic solution (e.g., viscous fluid) flows outwardly from the catheter 2115 / cannula 2120. As shown in the bottom view of FIG. 51, the O-ring 2124 acts as a barrier to prevent the outflowing viscous fluid from flowing further back along the catheter 2115 / cannula 2120, thus providing pressure to the area between the tip 3810 and the O-ring barrier. Another method is to use the external tip 3810 of the device to exert a depression (e.g., depress the TM) to create a reservoir and pump fluid into it to expand it.

[0178] In an embodiment of the present disclosure, an ocular device is inserted transluminally (e.g., through the AC), a catheter / cannula enters through the TM, and a catheter extends along the SC. The tip of the device has the ability to deliver fluid when the catheter is at rest, does not move, or is retracted. The tip of the device can deliver fluid radially (e.g., a distance equal to the 1 o'clock to 2 o'clock mark).

[0179] In aspects of the present disclosure, O-rings, gaskets, or larger flexible tubes can create constrained areas for localized high pressure that can be targeted to specific anatomy (e.g., toward the recovery tract or toward the TM). Other features that can impact the ophthalmic device are the handheld design, catheter extension / retraction, fluid delivery and pressure management, and removable fluid reservoirs.

[0180] In aspects of the present disclosure, the ocular device may be adapted to deliver one or more agents in place of or in combination with an OVD.

[0181] In aspects of the present disclosure, the ocular device can include a catheter that can be severed from the device to become an ocular implant. For example, the ocular device can be used to deploy the catheter, deliver the OVD and / or medication, and to severe the catheter from the handset (e.g., where the catheter enters the TM). The remaining catheter that is not severed is bioabsorbable and therefore is not used as a long-term implant. The severed part of the catheter is suitable for long-term implantation.

[0182] With modern canaloplasty catheters, one of the important aspects is to easily guide the catheter 3120 into Schlemm's canal. The catheter leading bulb 3122 (see the top view of FIG. 52) often rides on top of the TM rather than being inserted under it. In an embodiment of the present disclosure, the ophthalmic device 3900 can include a leading feature 3123 disposed on the bulb 3122 of the distal tip 3121 to allow the catheter 3120 to more easily enter Schlemm's canal, with the remaining part following suit. For example, the leading feature 3123 can be a flat surface that enters first (e.g., like a shoehorn), as shown in the middle view of FIG. 52. Here, the flat part 3123 will contact the anterior wall of Schlemm's canal. The leading feature 3123 can also be a point, as shown in the bottom view of FIG. 52. In aspects of the present disclosure, unlike current methods that use a blade to first make a slit or an insertion device tip to first make a stab incision, a leading structure 3123 may be used to enter Schlemm's canal first (e.g., partially supported by the insertion device which firmly holds this flat edge such that it firmly engages the TM but is still supported by the surrounding metal of the insertion device itself).

[0183] As shown in Fig. 53, the catheter 3130 can be used for multiple purposes such as injecting fluids and also for delivering / delivering and placing sutures. For example, as shown in the top depiction of Fig. 53, the catheter 3130 can have a distal hole 3134 (e.g., a hole at the leading end 3131) to allow for the passage of fluid (e.g., viscous fluid) out of the distal hole 3134 and out of an orifice 3133 in the sidewall of the catheter 3130. As shown in the bottom depiction of Fig. 53, a suture 3135 can be disposed within the catheter lumen 3136, and an end bulb 3132 of the suture 3135 can be flush with and / or block the distal hole 3134 of the catheter 3130. Any suitable structure can be used in place of the end bulb, such as, for example, a hook. Here, with the bulb 3132 of the suture 3135 capping the distal hole 3134, any fluid flushed through the lumen 3136, around the suture 3135 within the lumen 3136, will flow out the orifice 3133 in the side of the catheter 3130. In aspects of the present disclosure, a fluid flushing operation of the catheter 3130 may be performed and then the suture 3135 may be inserted into the catheter 3130 to load / position the suture 3135, or vice versa.

[0184] In an embodiment of the present disclosure, the catheter 3130 may be inserted 360 degrees into Schlemm's canal and then the bulb 3132 of the suture 3135 may be secured while the catheter 3130 is retracted, thereby leaving the suture 3135 in place while removing the catheter 3130 from the eye. The suture 3135 may then be tied or the suture 3135 may be left in place, for example. In an embodiment of the present disclosure, once the 360 ​​degree insertion is complete, the catheter 3130 may be cut and left in place. In an embodiment of the present disclosure, the catheter 3130 may be inserted first to perform viscous dilation by injecting viscous material, then the catheter 3130 may be removed and the suture 3135 may be inserted 360 degrees and left in place. Here, a device handpiece may be used to insert the catheter 3130, and then the catheter 3130 with the suture 3135 may be replaced in the device handpiece so that the same device handpiece may be used to insert / place the suture 3135. For example, after use, the catheter 3130 may be retracted and placed back into the stainless steel sleeve, and then the suture 3135 may be fed out of the stainless steel sleeve. In aspects of the present disclosure, the device handpiece may be configured only for introducing the suture 3135, and not for use with the catheter 3130.

[0185] In an embodiment of the disclosure, the suture 3135 may be affixed to an exterior portion of the catheter 3130 instead of being disposed within the lumen 3136 of the catheter 3130. This provides the advantage that the catheter 3130 may be inserted once and used for both viscous dilation and placement of the suture 3135. In an embodiment of the disclosure, as shown in FIG. 54, the catheter 3130 may have an axial recess 3137 (e.g., a slot) in the exterior sidewall such that the suture 3115 may be placed within the recess 3137 such that the combined diameter of the catheter 3130 and the suture 3135 within the slot 3137 is equal to the diameter of a normal catheter. In an embodiment of the disclosure, the catheter 3130 may have an outer ring recess 3138 for tying the suture 3135 around if necessary or desired.

[0186] 55, in aspects of the present disclosure, the bulb 3132 of the suture 3135 may be integrated with a suture ring 3139 to lock the suture 3135 in place. For example, the suture ring 3139 may be at one end of a 360 degree loop and the bulb 3132 may be at the other end of the 360 ​​degree loop such that when the bulb 3132 and ring 3139 are integrated, the 360 ​​degree suture loop remains in place.

[0187] As shown in Fig. 56, in aspects of the disclosure, the suture 3135 may be configured as a wave, where the wave suture 3135 provides for bunching or tensioning the TM independent of tying or tensioning the suture. The suture 3135 may have barbs, as shown in Fig. 57, which provide for maximizing the tension or anchoring strength of the suture 3135.

[0188] As shown in FIGS. 58A-58D, in aspects of the disclosure, a guidewire 4140 and tension suture 4135 may be inserted into the eye 115. As shown in FIG. 58A, a cannula 4120 of an ophthalmic device 4000 (FIG. 64) may be inserted into the eye 115 and aligned with Schlemm's canal 108 (e.g., Schlemm's canal). A guidewire 4140 may then pierce Schlemm's canal 108 and may be extended to follow Schlemm's canal 108 so that it surrounds the circumference of the eye 115, as shown in FIG. 58B. As shown in FIG. 58C, a catheter 4150 may be inserted and extended to move along the guidewire 4140 through Schlemm's canal 108 and around the circumference. In aspects of the disclosure, the catheter 4150 may inject or dispense a fluid (e.g., a viscous material) as it is moved through Schlemm's canal 108. The guidewire 4140 may then be disconnected from the ocular device 4000, leaving the guidewire 4140 positioned to pass entirely through Schlemm's canal 108, thereby encircling the eye 115, as shown in FIG. 58D, where the disconnected guidewire 4140 may provide inward tension.

[0189] In an embodiment of the present disclosure, the guidewire 4140 may be fixed in a shape slightly smaller than the diameter of Schlemm's canal 108. In an embodiment of the present disclosure, the guidewire 4140 may be formed of any suitable material (e.g., superelastic nitinol). In an embodiment of the present disclosure, the guidewire 4140 may be stretched more than 360 degrees, so that the ends of the guidewire 4140 overlap, as shown in FIG. 58D, thereby avoiding or minimizing stress concentrations and / or fracturing at the ends of the guidewire 4140. In an embodiment of the present disclosure, the catheter 4150 may be stretched through Schlemm's canal 108 around the circumference of the eye 115 prior to insertion of the wire 4170 (FIG. 59), such as in cases where it is not beneficial to guide the catheter 4150 with the guidewire 4140. Here, the wire 4170 may be deployed after the catheter 4150 is fully inserted.

[0190] 59, a simple push wire 4160 may be supported by the inner diameter of the catheter 4150 to deploy the wire 4170 (e.g., to extend the wire 4170 through Schlemm's canal 108). Here, the push wire 4160 may not be able to be retracted into the catheter 4150, and therefore any suitable technique for cutting or breaking the push wire 4160 and / or wire 4170 may be used to leave the push wire 4160 and / or wire 4170 within Schlemm's canal 108.

[0191] 60A and 60B, any suitable tensioning device 4180 may be used as a wire implanted in Schlemm's canal 108 of the eye 115. For example, the tensioning device 4180 may be a shape memory polymer helical coil suture 4180a that is deployed in Schlemm's canal 108, and upon reaching body temperature within the eye 115, the suture 4180a may be actuated, causing the suture 4180a to contract in an arching manner upon contact with the trabecular meshwork 106 and extending the suture 4180a towards the anterior chamber 100.

[0192] As shown in FIGS. 62A through 62C, the helical coil suture 4180a disposed within tissue 4185 is shown in various stages of contraction. Here, the shape memory polymer suture 4180a in FIG. 62A may have just been placed within Schlemm's canal 108 and may therefore be at a temperature of 20 degrees Celsius. In FIG. 62B, body heat within the eye 115 may warm the shape memory polymer suture 4180a to 37 degrees Celsius, causing the shape memory polymer suture 4180a to contract. As the temperature increases to, for example, 40 degrees Celsius, as shown in FIG. 62C, the shape memory polymer suture 4180a may contract further.

[0193] 61, the tensioning device 4180 can be a shape memory polymer tube 4180b that expands when deployed within Schlemm's canal 108. Again, the body heat of the eye 115 actuates the shape memory polymer tube 4180b, causing it to expand in contact with Schlemm's canal 108, stretching the trabecular meshwork 106 and elongating the shape memory polymer tube 4180b toward the anterior chamber 100. In an embodiment of the present disclosure, the tensioning device 4180 can be, for example, a Nitinol wire overmolded in silicone.

[0194] In another example, as shown in Figures 63A-63C, the tension device 4180 can be a shape memory polymer cylindrical device 4180c. As shown in Figure 63A, the shape memory polymer cylindrical device 4180c can be temporarily in a packaged state (e.g., when initially placed in Schlemm's canal 108). In Figure 63B, the shape memory polymer cylindrical device 4180c can be in a partially restored state (e.g., after being actuated by the body heat of the eye 115). In Figure 63C, the shape memory polymer cylindrical device 4180c can be in a fully restored state (e.g., after being fully actuated by the body heat of the eye 115).

[0195] In embodiments of the present disclosure, the tension device can be formed of a shape memory polymer and / or a shape memory alloy. In embodiments of the present disclosure, the tension device can be an injectable bioerodible or biodegradable stent device that dissolves or disappears after a set period of time (e.g., one week or more).

[0196] In aspects of the disclosure, the tensioning device can be a suture that is folded on itself at least once, braided, or otherwise retains an architecture that allows the viscoelastic to crosslink the suture material and be maintained in subsequent steps. In aspects of the disclosure, a viscoelastic can be placed over the folded suture so that it is held between the strands of the suture, after which the suture is placed into an insertion device and then the combination of suture and viscoelastic is inserted into Schlemm's Canal (e.g., both the suture and viscoelastic can be inserted into Schlemm's Canal and retained within Schlemm's Canal for an extended period of time).

[0197] In aspects of the present disclosure, the shape memory tube and / or shape memory suture may be selectively stretchable along its length, where as the portion of the tube / suture spanning 90 degrees expands, the portions of the tube / suture at 0 and 90 degrees may be pressed against the outer wall of Schlemm's canal, while the portion of the tube / suture at 45 degrees may stretch the TM toward the AC.

[0198] In an embodiment of the present disclosure, the ophthalmic device may include one or more lumens. In an embodiment of the present disclosure, the ophthalmic device may include slots of various sizes and / or holes of various shapes. In an embodiment of the present disclosure, the ophthalmic device may include delivery of the OVD anteriorly or posteriorly, or both (e.g., relative to the tip). In an embodiment of the present disclosure, the ophthalmic device may include a dynamically shaped anterior portion to aid in navigation through Schlemm's canal. In an embodiment of the present disclosure, the ophthalmic device may include click wheel delivery (e.g., as in a computer mouse). In an embodiment of the present disclosure, the ophthalmic device may include a dynamic delivery button (e.g., not clickable, but capable of titration based on the amount of button press). In an embodiment of the present disclosure, the ophthalmic device may include a sealing structure to aid in containing viscous fluids. In an embodiment of the present disclosure, the ophthalmic device may include the ability to dial in the delivery volume on the handpiece.

[0199] As shown in FIG. 64 , the ophthalmic device 4000 includes a housing 4100 and a cannula 4120 extending from the housing 4100. An actuation assembly 4200 may be disposed on and / or within the housing 4100. The actuation assembly 4200 may include a wheel 4210 (e.g., a scroll wheel) configured to rotate circumferentially in a fixed position within the housing 400. A movable housing ring 4220 may be disposed on the housing 4100 around a portion or the entirety of the wheel 4210. The movable housing ring 4220 may be coupled to the wheel 4210 such that when the wheel 4210 is pushed inwardly into the housing 4100, the movable housing ring 4220 and the wheel 4210 move together.

[0200] A fixed housing ring 4230 may be disposed on the housing 4100 around a portion or all of the movable housing ring 4220. The fixed housing ring 4230 remains fixed to the housing 4100 and therefore remains in a fixed position as the movable housing ring 4220 moves inward and outward. For example, the wheels 4210 may be pushed inward or may be biased outward (e.g., spring outward) upon releasing pressure applied to the wheels 4210. In aspects of the present disclosure, the housing 4100 itself may be disposed around a portion or all of the movable housing ring 4200 rather than the fixed housing ring 4230.

[0201] The haptic portion 4300 may be disposed on the housing 4100 or may be formed as part of the housing 4100. For example, the haptic portion 4300 may be a soft-touch rubber coating configured to provide a solid, 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 400 by any suitable process (e.g., overmolding, casting, welding, adhesive).

[0202] In use, the ophthalmic device 4000 may be grasped by a user's hand, where rotation of the wheel 4210 may extend or retract a wire (e.g., guidewire 4140) or catheter (e.g., catheter 4150) from or into the cannula 4120. For example, the user's finger or thumb may be used to scroll the wheel 4120 forward to extend the guidewire 4140 and / or catheter 4150. Similarly, the wheel 4210 may be scrolled backward, for example, to retract the guidewire 4140 and / or catheter 4150. Additionally, the user may push the wheel 4210 inward, thereby displacing the wheel 4210 and the movable housing ring 4220 inwardly into the housing 4100, thereby causing a pumping action, for example, to expel fluid through the cannula 4120. In aspects of the present disclosure, the above-described uses of the ophthalmic device 4000 may be performed for any suitable reason not related to a human medical process or treatment, such as maintenance or testing of the ophthalmic device 4000. Thus, the ophthalmic device 4000 is not limited to only human medical care, such as human eye medical care.

[0203] In this manner, the actuation assembly 4200 accomplishes multiple functions of the ophthalmic device 4000, such as advancing and / or retracting items (e.g., guidewire 4140, catheter 4150, tensioning device 4180) through the cannula 4120, as well as pumping fluid through the cannula 4120.

[0204] In some embodiments according to the present disclosure, an ophthalmic device includes: a housing; a cannula extending from the housing, the cannula having a lumen for fluid flow; a reservoir for holding fluid; and an actuation assembly, the actuation assembly including a rotatable wheel; and a movable housing ring coupled to the wheel, the rotatable wheel and the movable housing ring configured to move inwardly together toward an interior portion of the housing when a first force is applied inwardly on the wheel, and to move outwardly together away from the interior portion of the housing when a second force is applied outwardly on one of the wheel and the movable housing ring.

[0205] In some aspects of the present disclosure, a fixed housing ring is fixedly coupled to the housing and movably coupled to a movable housing ring, where the movable housing ring is configured to move inward and outward relative to the fixed housing ring. In some aspects of the present disclosure, the housing comprises a fixed housing ring coupled to a movable housing ring, where the movable housing ring is configured to move outward and inward relative to the fixed housing ring. In some aspects of the present disclosure, the rotatable wheel is configured to move a catheter through the cannula. In some aspects of the present disclosure, the rotatable wheel is configured to move a wire through the catheter. In some aspects of the present disclosure, the rotatable wheel is configured to move a wire through the cannula. In some aspects of the present disclosure, the rotatable wheel is configured to move a tensioning device through the cannula. In some aspects of the present disclosure, the rotatable wheel is configured to advance one of the catheter, the wire, and the tensioning device when the rotatable wheel is rotated in a forward direction toward the cannula. In some aspects of the present disclosure, the rotatable wheel is configured to retract one of the catheter, the wire, and the tensioning device when the rotatable wheel is rotated in a rearward direction away from the cannula.

[0206] In some aspects of the present disclosure, the actuation assembly is configured to pump fluid through the lumen of the cannula when the coupled rotatable wheel and the movable housing ring are moved inward. In some aspects of the present disclosure, the actuation assembly is configured to draw fluid from the fluid reservoir when the coupled rotatable wheel and the movable housing ring are moved outward. In some aspects of the present disclosure, a spring is coupled to one of the rotatable wheel and the movable housing ring, where the spring is biased to provide the second force. In some aspects of the present disclosure, the housing includes a haptic portion one of formed with and disposed on the housing, the haptic portion configured to provide an ergonomic grip.

[0207] In some aspects of the present disclosure, the catheter is configured to slidably move through the 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 within a wall of the catheter, the one or more side ports configured to provide fluid flow from the internal lumen to an exterior of the catheter. In some aspects of the present disclosure, the catheter comprises one or more O-rings disposed about the catheter, the one or more O-rings configured to provide a confining fluid zone on the exterior of the catheter. In some aspects of the present disclosure, the catheter comprises a bulb disposed at a tip of the catheter, the bulb having a leading structure including one of a flat surface extending from the bulb and a pointed portion extending from the bulb. In some aspects of the present disclosure, the catheter includes a lumen disposed at a tip of the catheter, the lumen configured to permit one of: passage of fluid from the internal lumen; slidable movement of a suture disposed within the internal lumen; and slidable movement of a tensioning device disposed within the internal lumen. In some aspects of the present disclosure, the catheter includes an axial recess disposed in an exterior surface of the catheter wall, the axial recess configured to receive one of a suture and a tensioning device.

[0208] In some embodiments according to the present disclosure, a method of operating an ophthalmic device includes: gripping a housing of the ophthalmic device; applying a rotational force to a wheel of an actuation 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 coupled to the wheel inwardly together, toward an interior portion of the housing based on the inward orthogonal force; pumping fluid through a lumen of the cannula based on the inward movement of the coupled wheel and movable housing ring; applying an outward orthogonal force to the coupled wheel and movable housing ring; and drawing fluid from a reservoir based on the outward movement of the coupled wheel and movable housing ring.

[0209] It will be understood that any particular order or hierarchy of blocks in the disclosed process methods is illustrative of an example approach. Based on design or implementation preferences, it will be understood that the particular order or hierarchy of blocks in the processes may be rearranged or that all of the blocks shown may be preferred. In some implementations, any of these blocks may be performed simultaneously.

[0210] This disclosure is provided to enable those skilled in the art to practice the various aspects described herein. This 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 readily apparent to those skilled in the art, and the general principles defined herein may be applied to other aspects.

[0211] Reference to a singular element is not intended to mean "one and only one" unless specifically stated otherwise, but rather "one or more." The term "several" means one or more unless specifically stated otherwise. Masculine pronouns (e.g., his) include feminine and neuter (e.g., her or its) and vice versa. Headings and subheadings, where present, are used for convenience only and do not limit the invention.

[0212] 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 an aspect, various alternative configurations and operations described herein may be considered at least equivalent.

[0213] As used herein, the phrase "at least one" preceding a list of items with the term "or" separating any of the items modifies the list as a whole, and not each individual item in the list. The phrase "at least one" does not require the selection of at least one item, but rather allows for the inclusion of at least one of any 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" can mean "A only," "B only," or "C only," or any combination of A, B, and C.

[0214] A phrase such as "aspect" does not imply that the aspect is essential to the subject technology or that the aspect applies to all configurations of the subject technology. Disclosure related to an aspect may apply to all configurations, or to one or more configurations. An aspect may provide one or more examples. A phrase such as an aspect may mean one or more aspects, and vice versa. A phrase such as "example" does not imply that the example is essential to the subject technology or that the example applies to all configurations of the subject technology. Disclosure related to an example may apply to all configurations, or to one or more examples. An example may provide one or more examples. A phrase such as an example may mean one or more examples, and vice versa. A phrase such as "configuration" does not imply that the configuration is essential to the subject technology or that the configuration applies to all configurations of the subject technology. Disclosure related to a configuration may apply to all configurations, or to one or more configurations. A configuration may provide one or more examples. A phrase such as a configuration can mean one or more configurations, and vice versa.

[0215] In one aspect, unless otherwise specified, all measurements, values, orders, positions, dimensions, sizes, and other specifications set forth in this specification, including the following claims, are approximate and not precise, and are intended to have a reasonable range consistent with their relevant function and customary in the art to which the invention pertains.

[0216] It will be understood that the particular order or hierarchy of steps, operations, or processes disclosed is illustrative of example approaches. It will be understood that the particular order or hierarchy of steps, operations, or processes may be rearranged based on design preferences. Some of the steps, operations, or processes may be performed simultaneously. Some or all of the steps, operations, or processes may be performed automatically, without user intervention. The accompanying method claims, if any, present elements of the various steps, operations, or processes in a simple order, and are not intended to be limited to only the particular order or hierarchy presented.

[0217] All structural and functional equivalents to the elements of the various embodiments described throughout this disclosure that are known or that later become known to those skilled in the art are intended to be expressly incorporated herein by reference and encompassed by the claims. Moreover, what is disclosed herein is intended to be directed to the public regardless of whether the disclosure is expressly recited in the claims. A claim element is not to be construed under the provisions of 35 U.S.C. 112(f) unless the element is expressly recited using the phrase "means for" or, in the case of a method claim, the element is recited using the phrase "step for." Moreover, to the extent that terms such as "include" or "have" are used, these terms are intended to be inclusive, as is "comprise" when the term "comprise" is employed as a transitional term in the claims.

[0218] The title, background, summary, brief description of the drawings, and abstract of this disclosure are incorporated into this disclosure as illustrative examples of the disclosure, not as limiting descriptions. They are presented with the understanding that they will not be used to limit the scope or meaning of the claims. In addition, it will be appreciated that in the Detailed Description, the description provides illustrative examples, and that various features are grouped together in various embodiments for the purpose of streamlining the disclosure. This method of disclosure is not to be interpreted as reflecting an intention that the claimed subject matter requires features other than those expressly recited in each claim. Rather, as reflected in the following claims, inventive subject matter lies in less than all features of a single disclosed structure or operation. The following claims are incorporated into the Detailed Description, where each claim stands on its own as separately claimed subject matter.

[0219] The claims are not intended to be limited to only the embodiments described herein, but are intended to be accorded the full scope consistent with the claims set forth herein and to encompass all legal equivalents. However, no claim is intended to encompass subject matter that fails to meet the requirements of 35 U.S.C. §§ 101, 102, or 103, and no claim should be construed as failing to meet the requirements of 35 U.S.C. §§ 101, 102, or 103.

Claims

1. Housing and a cannula extending from the housing, the cannula having a lumen for fluid flow; a reservoir for holding a fluid; and an initiation assembly, the initiation assembly comprising: A rotatable wheel; 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 an interior portion of the housing, when a first force is applied inwardly on the wheel, and to move outwardly together, away from the interior portion of the housing, when a second force is applied outwardly on one of the wheel and the movable housing ring; An ophthalmic device comprising:

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

3. The ophthalmic device of claim 1 , wherein the housing comprises a fixed housing ring coupled to the movable housing ring, the movable housing ring configured to move outwardly and inwardly relative to the fixed housing ring.

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

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

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

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

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

10. 2. The ophthalmic device of claim 1, wherein the actuation assembly is configured to pump fluid through the lumen of the cannula when the coupled rotatable wheel and movable housing ring are moved inwardly.

11. The ophthalmic device of claim 1 , wherein the actuation assembly is configured to draw fluid from the fluid reservoir when the coupled rotatable wheel and movable housing ring are moved outwardly.

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

13. The ophthalmic device of claim 1 , wherein the housing comprises a haptic portion one of formed with the housing and disposed on the housing, the haptic portion configured to provide an ergonomic grip.

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

15. 15. The ophthalmic device of claim 14, wherein a portion of the catheter comprises one or more side ports disposed within a wall of the catheter, the one or more side ports configured to provide fluid flow from the internal lumen to an exterior of the catheter.

16. 16. The ophthalmic device of claim 15, wherein the catheter comprises one or more O-rings disposed about the catheter, the one or more O-rings configured to provide a confining fluid zone on an exterior of the catheter.

17. 15. The ophthalmic device of claim 14, wherein the catheter comprises a bulb disposed at a tip of the catheter, the bulb having a leading structure including one of a flat surface extending from the bulb and a pointed portion extending from the bulb.

18. The catheter includes a lumen disposed at a distal end of the catheter, the lumen comprising: the passage of fluid from said internal lumen; slidable movement of a suture disposed within the inner lumen; and slidable movement of a tensioning device disposed within the internal lumen; The ophthalmic device of claim 14 configured to achieve one of the following:

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

20. 1. A method of operating an ophthalmic device, comprising: gripping a housing of the ophthalmic device; applying a rotational force to a wheel of an actuation 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 coupled to the wheel inwardly as a unit toward an interior portion of the housing based on the inward orthogonal force; pumping fluid through a lumen of the cannula based on the inward movement of the coupled wheels and the movable housing ring; applying an outward orthogonal force to the coupled wheels and the movable housing ring; and drawing fluid from a reservoir based on outward movement of the coupled wheels and the movable housing ring.

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