System and method for viscoelastic material delivery

Abstract

A method and device for reducing intraocular pressure in a patient. The method may include deploying and administering a viscoelastic material to Schlemm's canal to open an outflow pathway for aqueous humor. The device is adapted to carry out the method. The viscoelastic material may be configured to reduce intraocular pressure within the eye.

Description

Technical Field

[0001] Cross - reference to Related Applications This application claims the benefit of priority of U.S. Provisional Patent Application No. 63 / 136,148, filed on January 11, 2021, and U.S. Provisional Patent Application No. 63 / 236,598, filed on August 24, 2021, each of which is hereby incorporated by reference in its entirety.

[0002] All publications and patent applications mentioned in this specification are hereby incorporated by reference to the same extent as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference.

[0003] The present disclosure generally relates to, but is not limited to, medical devices and methods for manufacturing medical devices. The present invention generally relates to devices and systems for insertion into the eye. More particularly, the present invention relates to devices that facilitate the movement of fluid from one region of the eye to another region of the eye. Further, the present disclosure relates to systems, devices, and methods for injecting a viscoelastic material into the Schlemm's canal open aqueous humor outflow pathway.

Background Art

[0004] According to a draft by the National Eye Institute (NEI) of the United States National Institutes of Health (NIH), glaucoma is now the leading cause of irreversible blindness in the world and the second leading cause of blindness after cataracts worldwide. Thus, the NEI draft concludes that "it is important to continue to devote considerable attention and resources to determining the pathophysiology and treatment of this disease." Glaucoma researchers have found a strong correlation between high intraocular pressure and glaucoma. For this reason, ophthalmic treatment specialists constantly examine patients for glaucoma by measuring intraocular pressure using a device known as a tonometer. Many modern tonometers perform this measurement by suddenly blowing air onto the outer surface of the eye.

[0005] The eye can be conceptualized as a sphere filled with fluid. Inside the eye are two types of fluid. The chamber behind the lens is filled with a viscous fluid known as vitreous fluid. The chamber in front of the lens is filled with a fluid known as aqueous humor. Whenever a person looks at an object, they are always seeing that object through both the vitreous fluid and the aqueous humor.

[0006] When humans see an object, they always see it through the cornea and the lens of the eye. Because they are transparent, the cornea and lens cannot contain blood vessels. Therefore, blood does not flow through the cornea and lens to nourish these tissues and remove waste products from them. Instead, these functions are performed by aqueous humor. The continuous flow of aqueous humor through the eye nourishes the parts of the eye that do not have blood vessels (e.g., the cornea and lens). This flow of aqueous humor also removes waste products from these tissues.

[0007] Aqueous humor is produced by an organ known as the ciliary body. The ciliary body contains epithelial cells that continuously secrete aqueous humor. In a healthy eye, when new aqueous humor is secreted by the epithelial cells of the ciliary body, the flow of aqueous humor flows out of the anterior chamber, through the trabecular network, and into Schlemm's canal. This excess aqueous humor enters the venous bloodstream from Schlemm's canal and is carried away with the venous blood, leaving the eye.

[0008] When the eye's natural drainage mechanism malfunctions, the pressure inside the eye begins to rise. Researchers have theorized that prolonged exposure to high intraocular pressure can cause damage to the optic nerve, which transmits sensory information from the eye to the brain. This damage to the optic nerve leads to loss of peripheral vision. As glaucoma progresses, more and more of the field of vision is lost, and eventually the patient becomes completely blind. [Overview of the Initiative] [Means for solving the problem]

[0009] This invention provides the design, materials, and method of use of a medical device.

[0010] An exemplary method for lowering a patient's intraocular pressure may include administering a viscoelastic material into Schlemm's canal of the eye to open the outflow pathway for aqueous humor. In some embodiments, the viscoelastic material may be administered before or after deploying an ophthalmic implant into Schlemm's canal.

[0011] One aspect of the present invention provides a method for treating a patient's eye using an ophthalmic system. In some embodiments, the method includes the steps of: inserting the distal end of a cannula of the ophthalmic system into the anterior chamber of the eye; positioning the cannula to be in fluid communication with Schlemm's canal, wherein the conduit is located within the cannula; activating a first control unit of the ophthalmic system to advance the conduit from the cannula into Schlemm's canal; and activating a second control unit of the ophthalmic system to administer a viscoelastic material into Schlemm's canal through a viscoelastic material delivery port of the conduit without moving the conduit. In some embodiments, the method also includes the step of activating the first control unit to retract the conduit into Schlemm's canal and into the cannula.

[0012] In some embodiments, the method may include a step of pressurizing the volume of viscoelastic material within a viscoelastic module, and the step of activating a second control unit includes activating a second control unit of an ophthalmic system to administer the viscoelastic material from the viscoelastic module into a conduit. In some such embodiments, the ophthalmic system may have a handle, with the cannula, first control unit, and second control unit extending from and supported by the handle, and the viscoelastic module positioned outside the handle. In some embodiments, the step of pressurizing the volume of viscoelastic material may include an additional step of applying a spring to the plunger of a viscoelastic syringe positioned within the viscoelastic module.

[0013] In some embodiments, the step of pressurizing a volume of viscoelastic material includes the step of pressurizing a reservoir within a viscoelastic module. In some such embodiments, the step of pressurizing the reservoir includes the step of compressing a spring engaged with the wall of the reservoir, for example, by operating an actuator extending from the viscoelastic module.

[0014] Some embodiments include an additional step of filling a reservoir with viscoelastic material from a viscoelastic syringe. Some such embodiments optionally include an additional step of advancing the viscoelastic material from the viscoelastic syringe into a conduit before filling the reservoir with viscoelastic material from the viscoelastic syringe.

[0015] Some embodiments have an additional step of providing tactile feedback while operating the first control unit, the tactile feedback correlates with the length of the conduit moving in or out of the cannula.

[0016] Some embodiments of this method also include the step of advancing the ophthalmic implant into Schlemm's canal before the viscoelastic material is administered into Schlemm's canal. Some embodiments may also include the step of advancing the ophthalmic implant into Schlemm's canal after the viscoelastic material has been administered into Schlemm's canal.

[0017] Another aspect of the present invention provides an ophthalmic viscoelastic delivery system comprising: a handle; a cannula defining a passage extending from the handle to a distal cannula opening, the cannula being advanced through the anterior chamber of the patient's eye and sized to position the distal cannula opening in fluid communication with Schlemm's canal of the eye; a conduit slidably disposed within the cannula passage, including a viscoelastic delivery port, the conduit being sized to allow at least a distal portion to be advanced from the cannula into Schlemm's canal; a viscoelastic module in fluid communication with the conduit and the viscoelastic delivery port, the viscoelastic module being configured to include a pressurized volume of viscoelastic material outside the handle; a first control unit configured to adjust the position of the conduit and the viscoelastic delivery port relative to the cannula; and a second control unit configured to discharge the pressurized viscoelastic material from the viscoelastic module through the conduit and the viscoelastic delivery port into Schlemm's canal.

[0018] In some embodiments of the delivery system, the viscoelastic module also includes a cradle configured to receive a viscoelastic syringe and a force assembly configured to contact the plunger of the viscoelastic syringe, the force assembly being further configured to apply a constant force to the plunger. In some such embodiments, the force assembly also has an adjustment mechanism configured to adjust the position of the force assembly relative to the plunger.

[0019] In some embodiments, the force assembly of a viscoelastic module includes a reservoir and a spring configured to pressurize the viscoelastic material within the reservoir. Some such embodiments also include an actuator extending from the viscoelastic module and configured to compress the spring to pressurize the reservoir.

[0020] In some embodiments, the viscoelastic module further has an inlet port adapted to engage with a viscoelastic syringe, the inlet port being able to fluidly communicate with a reservoir. In some such embodiments, the viscoelastic module also has a check valve positioned between the inlet port and the reservoir, the check valve being configured to open to allow pressurized viscoelastic material to flow from the viscoelastic syringe through the inlet port to the reservoir, and to close to prevent viscoelastic material from flowing out of the reservoir through the inlet port.

[0021] In some embodiments, the first and second control units are located on a handle. In some embodiments, a single actuation of the first control unit moves the conduit by a known distance, and in some embodiments, a single actuation of the second control unit dispenses a known amount of viscoelastic material from the conduit and viscoelastic material delivery port into the Schlemm tube. Some embodiments provide a cantilever spring adapted to engage with the first control unit and provide tactile feedback of the movement of the first control unit.

[0022] In some embodiments, the second control unit includes a toggle lever operable to move to a first position to open a valve for delivering viscoelastic material from a viscoelastic module into a conduit, and the second control unit further includes a spring operable to move the toggle to a second position to close the valve. Some such embodiments also have a toggle lock configured to hold the toggle lever in the first position. The toggle lock is removablely located on the outer surface of the handle and can engage with the toggle lever.

[0023] In some embodiments, the delivery system also includes a tube extending from a viscoelastic module to a handle, the tube having a fluid lumen extending from the outlet of the viscoelastic module to an inlet control unit within the handle. The tube may have a length of 3 to 4 inches.

[0024] A further aspect of the present invention provides an ophthalmic delivery system comprising: a handle; a hub positioned at the distal end of the handle and configured to be rotatable relative to the handle; a cannula coupled to the hub and configured to rotate with the hub, having a curved distal end, defining a passage extending from the handle to the distal cannula opening, advancing through the anterior chamber of the patient's eye, and sized and configured to position the distal cannula opening in fluid communication with Schlemm's canal of the eye; a cannula orientation marking rotatable with the hub and visible from the outside of the delivery system, the cannula orientation marking aligned with the radial direction in which the curved distal end of the cannula extends; and a fixed marking supported by the handle, the cannula orientation marking and the fixed marking together indicating the orientation of the curved distal end of the cannula relative to the orientation of the handle.

[0025] In some embodiments, the system also includes a conduit slidably positioned within the cannula passage, comprising a viscoelastic material delivery port, the conduit being sized and configured so that at least the distal portion of the conduit can advance forward from the cannula into Schlemm's canal, and a reservoir adapted for delivering viscoelastic material into the conduit. In some such embodiments, the system includes a control unit configured to adjust the position of the conduit and the viscoelastic material delivery port relative to the cannula. In some embodiments, the system includes a control unit configured to release pressurized viscoelastic material from the reservoir through the conduit and the viscoelastic material delivery port into Schlemm's canal.

[0026] The above summary of some examples and embodiments is not intended to describe each or all of the embodiments disclosed in this disclosure. The following brief description and detailed description of the drawings are illustrative of these embodiments more specifically, but are also illustrative and not limiting.

[0027] This disclosure can be better understood by considering the following detailed description of various embodiments relating to the attached drawings.

Brief Description of the Drawings

[0028] [Figure 1] FIG. 1 is a schematic perspective view showing a part of a human eye and a part of an intraocular implant disposed within Schlemm's canal. [Figure 2] FIG. 2 is a schematic representation of a medical procedure according to the present disclosure. [Figure 3] FIG. 3 is an enlarged perspective view further showing the delivery system and the patient's eye. [Figure 4] FIG. 4 shows an example of a cannula of a delivery system including a conduit and a viscoelastic delivery port. [Figure 5] FIG. 5 is a perspective view illustrating one embodiment of a viscoelastic delivery system. [Figure 6] FIG. 6 is a partial cross-sectional view and a partial side view showing the viscoelastic module of the viscoelastic delivery system in an open, unpressurized configuration. [Figure 7] FIG. 7 is a partial cross-sectional view and a partial side view showing the viscoelastic module of FIG. 6 in a closed, pressurized configuration. [Figure 8] FIG. 8 is a perspective view showing a viscocylinder loaded into the viscoelastic module of FIGS. 6 - 7. [Figure 9] FIG. 9 is a perspective view showing a viscocylinder loaded into the viscoelastic module of FIGS. 6 - 8. [Figure 10] FIG. 10 is a perspective view showing another embodiment of the viscoelastic delivery system. [Figure 11] FIG. 11 is a side cross-sectional view showing details of the viscoelastic module of the viscoelastic delivery system of FIG. 10. [Figure 12] FIG. 12 is a side cross-sectional view of the viscoelastic module of FIG. 11 showing a reservoir completely filled with a viscoelastic material. [Figure 13] FIG. 13 is a perspective view showing one embodiment of a viscoelastic module having a partially see-through housing and scale markings. [Figure 14]Figure 14 is a perspective view showing the viscoelastic module of Figure 13, which has a clip for attaching the module to, for example, the user's wrist or arm, or to a column. [Figure 15] Figure 15 is a side view of yet another embodiment of the viscoelastic module of a viscoelastic material delivery system. [Figure 16] Figure 16 is a cross-sectional view of the viscoelastic module of Figure 15 in its pre-filled configuration. [Figure 17] Figure 17 is a cross-sectional view of the viscoelastic modules of Figures 15-16 in a filled and pressurized configuration. [Figure 18] Figure 18 is a cross-sectional view of the viscoelastic modules shown in Figures 15-17 in the empty configuration. [Figure 19] Figure 19 is a partial cross-sectional view showing the changes from the embodiments shown in Figures 15-18. [Figure 20] Figure 20 is a cross-sectional view showing yet another embodiment of a viscoelastic module in a viscoelastic delivery system. [Figure 21] Figure 21 is a cross-sectional view showing details of the viscoelastic module in Figure 20. [Figure 22] Figure 22 is a perspective view of a viscoelastic delivery system showing a viscoelastic module (such as the viscoelastic module shown in Figure 14) attached to the user's arm. [Figure 23] Figure 23 is a perspective view of a viscoelastic delivery system showing a viscoelastic module (such as the viscoelastic module shown in Figure 14) mounted on an IV stand. [Figure 24] Figure 24 is a perspective view of a viscoelastic material delivery system according to an embodiment of the present invention, which includes first and second control units configured to control the delivery of a viscoelastic material and the adjustment of the position of the conduit relative to the cannula. [Figure 25] Figure 25 is a cross-sectional view of the delivery system shown in Figure 24. [Figure 26] Figure 26 is a cross-sectional view showing an embodiment of the delivery system shown in Figures 24-25. [Figure 27] Figure 27 is a cross-sectional view showing an embodiment of the delivery system shown in Figures 24-26. [Figure 28] Figure 28 is a cross-sectional view showing an embodiment of the delivery system shown in Figures 24-27. [Figure 29] Figure 29 is a cross-sectional view of a portion of the viscoelastic material delivery system shown in Figures 24-28, but with an alternative design for the strain relief element according to an embodiment of the present invention. [Figure 30] Figure 30 is a cross-sectional view of a portion of the viscoelastic material delivery system shown in Figures 24-28, but with an alternative design for the forward wheel according to an embodiment of the present invention. [Figure 31] Figure 31 is a cross-sectional view of part of the viscoelastic delivery system shown in Figures 24-28, but with yet another alternative design for the forward wheel. [Figure 32] Figure 32 is a partial cross-sectional view showing an embodiment of a viscoelastic material delivery system according to an alternative embodiment of the present invention. [Figure 33] Figure 33 is a perspective view of some of the components of the viscoelastic material delivery system shown in Figure 32. [Figure 34] Figure 34 is a perspective view of the viscoelastic material delivery system shown in Figures 32-33. [Figure 35] Figure 35 is a partial cross-sectional view of an alternative visco control element shape for use with the viscoelastic delivery systems shown in Figures 32-34. [Figure 36] Figure 36 is a perspective view showing a toggle lock for use with the viscoelastic material delivery system of the present invention. [Figure 37] Figure 37 is a perspective view showing an alternative toggle lock for use with the viscoelastic material delivery system of the present invention. [Figure 38] Figure 38 is a perspective view showing the chamfered distal tip of a cannula extending from a viscoelastic material delivery system according to an embodiment of the present invention. [Figure 39] Figure 39 is an elevation view of the chamfered distal tip of the cannula shown in Figure 38. [Figure 40] Figure 40 is a perspective view showing the cannula rotation feature of a viscoelastic material delivery system. [Figure 41] Figure 41 is a perspective view of the cannula rotation feature portion of Figure 40. [Figure 42] Figure 42 is a perspective view of the cannula rotation feature shown in Figure 40. [Figure 43] Figure 43 is a perspective view of the components of the cannula rotation feature shown in Figure 40. [Figure 44] Figure 44 is a perspective view of another component of the cannula rotation feature shown in Figure 40. [Figure 45] Figure 45 is a flowchart illustrating a method for treating a patient's eye. [Modes for carrying out the invention]

[0029] While this disclosure can be modified in various forms and alternatives, specific examples are shown in the drawings and described in more detail thereafter. However, it should be understood that the present invention is not limited to the specific embodiments described. On the contrary, the present invention encompasses all modifications, equivalents, and alternatives that fall within the spirit and scope of this disclosure.

[0030] The following description should be read in reference to the drawings, which are not necessarily to a constant scale, and similar reference numbers in some drawings indicate similar elements. The detailed description and drawings are intended to illustrate, not limit, the claimed invention. Those skilled in the art will recognize that the various elements described and / or shown may be in various combinations and configurations without departing from the scope of this disclosure. The detailed description and drawings illustrate embodiments as examples of the claimed invention.

[0031] Definitions of specific terms are provided below. These definitions apply unless different definitions are given in the claims or elsewhere in this specification.

[0032] All numerical values ​​herein, whether expressly indicated or not, may be modified by the term “about.” The term “about” generally refers to a range of numbers that a person skilled in the art could consider equivalent to the value shown (i.e., having the same or substantially the same function or result). Often, the term “about” may include numbers rounded to the nearest significant figure. Any other use of the term “about” (i.e., in a non-numerical context) may be considered to have their own general and customary definitions as understood in and consistent with the context herein, unless otherwise noted.

[0033] Listing numerical ranges by endpoints includes all numbers within that range (for example, 1-5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5).

[0034] As used herein and in the appended claims, the singular forms "a," "an," and "the" include or refer to singular and plural subjects, unless otherwise specified. As used herein and in the claims, the term "or" is generally used to include "and / or," unless otherwise specified.

[0035] References in this specification to “certain embodiments,” “several embodiments,” “other embodiments,” etc., indicate that the embodiments described may include certain features, structures, or characteristics, but not all embodiments may necessarily include those features, structures, or characteristics. Furthermore, such phrases do not necessarily refer to the same embodiments. Moreover, if certain features, structures, or characteristics are described in relation to one embodiment, it will be apparent to those skilled in the art that such features, structures, or characteristics will be affected in relation to other embodiments, whether or not they are explicitly stated otherwise. In other words, each of the various elements described below, even if not explicitly shown in specific combinations, can be conceivably combined or configured with each other to form other additional embodiments or to perform and / or enhance the embodiments described, as will be understood by those skilled in the art.

[0036] The following detailed description should be read with reference to the drawings, and similar elements in different drawings are identified by the same reference number. Each drawing is not necessarily to a constant scale, but illustrates an embodiment that is useful for explanation and is not intended to limit the scope of this disclosure.

[0037] Figure 1 is a schematic perspective view showing a portion of a human eye 20. The eye 20 is conceptualized as a fluid-filled sphere having two chambers. The sclera 22 of the eye 20 surrounds the posterior chamber 24, which is filled with a viscous fluid known as vitreous humor. The cornea 26 of the eye 20 encloses the anterior chamber 30, which is filled with a fluid known as aqueous humor. The cornea 26 is in contact with the sclera 22 at the edge 28 of the eye 20. The lens 32 of the eye 20 is located between the anterior chamber 30 and the posterior chamber 24. The lens 32 is held in place by several ciliary zonules 34. Whenever a human being looks at an object, they are always seeing the object through the cornea, aqueous humor, and lens of the eye. Because they are transparent, the cornea and lens do not contain blood vessels. Therefore, blood does not flow through the cornea and lens to nourish these tissues and remove waste products from them. Instead, these functions are performed by the aqueous humor. The continuous flow of aqueous humor through the eye nourishes the parts of the eye that lack blood vessels (such as the cornea and lens). This flow of aqueous humor also removes waste products from these tissues.

[0038] Aqueous humor is produced by an organ known as the ciliary body. The ciliary body contains epithelial cells that continuously secrete aqueous humor. In a healthy eye, the flow of aqueous humor is interrupted when new aqueous humor is secreted by the epithelial cells of the ciliary body, causing it to flow out of the eye. This excess aqueous humor enters the bloodstream and is carried away by venous blood leaving the eye.

[0039] In a healthy eye, aqueous humor flows out of the anterior chamber 30 through the trabecular network 36 and enters Schlemm's canal 38, located on the outer edge of the iris 42. The aqueous humor exits Schlemm's canal 38 by flowing through several outlets 40. After leaving Schlemm's canal 38, the aqueous humor is absorbed into the venous blood flow.

[0040] Figure 2 is a schematic representation of this detailed medical procedure. In the procedure in Figure 2, a physician is treating patient P's eye 400. In the procedure in Figure 2, the physician holds the handpiece of the viscoelastic delivery system 450 in his right hand RH. The physician's left hand (not shown) may be used to hold the handle H of the goniolens 402. Alternatively, some physicians may prefer to hold the delivery system handpiece in their left hand and the goniolens handle H in their right hand RH.

[0041] During the procedure shown in Figure 2, the physician can use a goniolens 402 and a microscope 404 to view the inside of the anterior chamber. Detail A in Figure 2 is a stylized simulation of the image the physician saw. The distal portion of the cannula 452 can be seen in Detail A. The shadow-like lines indicate the location of Schlemm's canal SC lying beneath the various tissues surrounding the anterior chamber (e.g., the trabecular meshwork). The distal opening 454 of the cannula 452 is positioned near Schlemm's canal SC of eye 400.

[0042] The method described in this detail may include the step of advancing the distal end of the cannula 452 through the cornea of ​​the eye 400 so that the distal portion of the cannula 452 is positioned within the anterior chamber. The cannula 452 may then be used to enter Schlemm's canal of the eye, for example, by penetrating the wall of Schlemm's canal with the distal end of the cannula 452. The distal opening 454 of the cannula 452 may be in fluid communication with the lumen defined by Schlemm's canal. The viscoelastic material can be delivered from the cannula into Schlemm's canal to an open aqueous humor outflow pathway. Delivery of the viscoelastic material into Schlemm's canal may facilitate the flow of aqueous humor from the anterior chamber.

[0043] Figure 3 is an enlarged perspective view further showing the viscoelastic delivery system 450 and eye 400 shown in the previous figure. In Figure 3, a cannula 452 extending from the handle 453 of the viscoelastic delivery system 450 is shown to extend through the cornea 426 of the eye 400. The distal portion of the cannula 452 is positioned within the anterior chamber defined by the cornea 426 of the eye 400. In the embodiment of Figure 3, the cannula 452 is configured so that its distal opening 454 can be in fluid communication with Schlemm's canal.

[0044] In the embodiment shown in Figure 3, the viscoelastic material can be administered into Schlemm's canal by a cannula. In some embodiments, a conduit or microcatheter may be positioned within the cannula of the viscoelastic delivery system. The conduit may be configured to advance from the cannula into Schlemm's canal. In this embodiment, the viscoelastic material can be delivered from the conduit into Schlemm's canal. The delivery system 450 includes a mechanism that allows the conduit to advance and retract along the length of the cannula 452. The viscoelastic material may be delivered into Schlemm's canal of the eye 400 by advancing the conduit through the distal opening of the cannula 452 while the distal opening is in fluid communication with Schlemm's canal. The viscoelastic material can then be administered from the conduit into Schlemm's canal.

[0045] The viscoelastic material can be delivered to the Schlemm's canal of the eye before or after delivering an ophthalmic implant into the patient's eye. In one embodiment, the delivery system may be connected to a Visco Module 460, which is separate from the body or handle 453 of the delivery system 450. The Visco Module 460 may be configured to deliver the viscoelastic material to a conduit in the cannula of the delivery system via a lumen or tube. In one embodiment, the delivery system may include a Visco Trigger 462 on the handle 453, which is configured to release the viscoelastic material from the Visco Module 460 into the conduit of the delivery system.

[0046] The delivery system 450 may further include a conduit advance wheel 464 configured to advance or retract the conduit within the cannula and Schlemm's canal. For example, advancing the conduit advance wheel 464 distally (e.g., towards the cannula) advances the conduit toward the distal end of the cannula, allowing it to partially exit the cannula into Schlemm's canal in the patient's eye when the distal end of the cannula is in fluid communication with Schlemm's canal. Furthermore, moving the conduit advance delivery wheel proximally (e.g., toward the Viscotriga 462) moves the conduit proximal within the cannula, allowing it to enter and exit Schlemm's canal. A separate conduit advance wheel 464 allows the conduit to be moved within Schlemm's canal without administering viscoelastic material from the conduit. Similarly, the Viscotriga 462 on the handle allows the viscoelastic material to be administered from the conduit into Schlemm's canal without moving the conduit.

[0047] Figure 4 shows the distal end of the cannula 452 of the viscoelastic delivery system of Figure 3. In Figure 4, the conduit 453 is shown to partially extend from the distal opening 454 of the cannula 452. As described above, the conduit 453 may be slidably positioned within the cannula and may be partially advanced beyond the distal opening of the cannula (for example, by using a conduit advance wheel 464). The conduit 453 may be made of, for example, Grilamid® polyamide, Pebax® elastomer, nylon, or any other suitable material. In one embodiment, the conduit may have a size (e.g., 0.08-inch OD and 0.06-inch ID) and cross-sectional shape (e.g., circular cross-section, elliptical cross-section, etc.) that matches the internal size and cross-sectional shape of the cannula. It should be understood that the conduit 453 can be of any shape as long as it can be slidably positioned within the cannula. The conduit 453 can have a length of 16–18 mm and can extend halfway around Schlemm's cannula and beyond the distal end of the cannula. The conduit 453 may include a distal opening 455, which may be configured to deliver viscoelastic material into a body structure such as Schlemm's cannula. It should be understood that the conduit 453 includes a lumen that is in fluid communication with a source of viscoelastic material (such as a viscomodule 460) to facilitate the administration of viscoelastic material. While the embodiment useful for explanation includes only the distal opening 455, in other embodiments the conduit may include additional openings, such as openings along the sides of the conduit.

[0048] Figure 5 shows a viscoelastic delivery system 500, which includes a delivery system 550 and a Visco module 560 located outside the delivery system 500. The delivery system 550 has a handle 552 and a cannula 554 extending from the distal end of the handle 552. The cannula 554 has an internal passage and a distal opening configured to be in fluid communication with Schlemm's tube. A conduit (not shown) is movably positioned within the cannula 554 so that it can be advanced from the cannula into Schlemm's tube and retracted into the cannula.

[0049] The Visco Module 560 can be adapted to receive or accommodate various Visco syringes 566. The Visco syringe 566 can be connected to a tube 568 (e.g., via a female Luer connector) using sterile techniques to fluidly couple the viscoelastic material in the internal chamber of the Visco syringe to a conduit in the delivery system 550. In one embodiment, the Visco Module 560 may be configured to automatically pressurize the internal chamber of the Visco syringe 566 when the syringe is inserted into the module. Toggle the Visco Trigger 562 on the handle 552 of the delivery system 550, causing a pressurized flow of viscoelastic material to flow from the Visco syringe and Visco Module into the delivery system 550, exiting through one or more ports of the conduit in the delivery system and entering the Schlemm's tube. As described above, the delivery system may also include a conduit advance wheel 564 configured to advance and retract the conduit in the cannula of the delivery system, thereby advancing and retracting the conduit in the Schlemm's tube. A separate conduit advance wheel 564 allows the conduit to be moved within the Schlemm tube without dispensing viscoelastic material from the conduit. Similarly, a visco trigger 562 on the handle allows the viscoelastic material to be dispensed from the conduit into the Schlemm tube without moving the conduit.

[0050] Figures 6-7 show cross-sectional views of the Visco Module 660 in an open, non-pressurized configuration and a closed, pressurized configuration, respectively. In this embodiment, the Visco syringe 666 can be resting in a cradle 670 which can be configured to accommodate a wide variety of Visco syringe sizes and shapes. A spring assembly 674 (e.g., a compression spring or a constant-force spring) can be positioned to contact the plunger 672 of the syringe 666. In some embodiments, the spring assembly 674 may include an outer adjuster barrel 676 configured to adjust the position of the spring assembly to contact the plunger 672. Rotation of the outer adjuster barrel 676 can adjust the relative position of the outer adjuster barrel 676 with respect to the inner adjuster barrel 678. For example, the outer adjuster barrel may be threaded complementary to the inner adjuster barrel 678 to facilitate adjustment of the relative position of the outer adjuster barrel with respect to the plunger 672.

[0051] The Visco Module 660 in Figures 6-7 further includes a piston 680 coupled to one end of an arm 682 and a module cover 684 coupled to the other end of the arm. In some embodiments, these components may be rotatably coupled together using a pivot or hinge. When the Visco Module is in the open configuration of Figure 6, the module cover 684 pulls the arm 682 and piston 680 away from the spring assembly 674. However, in the closed configuration of Figure 7, when the module cover 684 is closed, the arm and piston move into the spring assembly, partially compressing the spring. The spring assembly then begins to apply a constant force to the plunger 672 of the syringe 666, effectively pressurizing the syringe. The operator can then control the delivery of the viscoelastic material from the reservoir of the syringe 666 to the delivery system by, for example, deploying a Visco trigger (such as the Visco trigger 562 in Figure 5) on the delivery system connected to the Visco Module.

[0052] Figures 8-9 are additional diagrams of the Visco module shown in Figures 6-7, illustrating the loading of the Visco syringe 666 into the Visco module 660. The outer adjuster barrel 676 and inner adjuster barrel 678 are also shown in Figures 8-9, illustrating how fine adjustments can be made to position the spring assembly relative to the syringe plunger.

[0053] Figures 10–12 show another embodiment of the viscoelastic delivery system 700, including a delivery system 750 and a visco module 760. The delivery system 750 has a handle 752 and a cannula 754 extending from the distal end of the handle 752. The cannula 754 has an internal passage and a distal opening configured to be in fluid communication with a Schlemm tube. A conduit (not shown) is movably positioned within the cannula 754 so as to be advanced from the cannula into the Schlemm tube and retracted into the cannula. The conduit has one or more outlet ports. A toggleable visco trigger 762 on the delivery system 750 may allow a pressurized flow of viscoelastic material to flow from the visco module 760 through a tube 768 into the conduit in the cannula 754 and exit through the conduit's outlet port.

[0054] The Visco Module 760 is adapted to receive viscoelastic material from a Visco syringe before using the system to treat a patient. As shown in Figures 11-12, the outlet of the Visco syringe can be connected to a Luer fitting 786 at the inlet 785 of the Visco Module 760. The Visco syringe can inject viscoelastic material through the inlet 785 and a one-way valve 787 into a passage 789 leading to a Luer connector. A tube 768 connected to a connector 793 extends to the delivery system. The system can be primed during the injection of viscoelastic material from the Visco syringe by opening the Visco trigger 762 until the viscoelastic material enters from the inlet 785, passes through the passage 789 and tube 768, and exits through the outlet port of the conduit, as shown in Figure 11. Releasing the Visco trigger stops the flow of viscoelastic material through the conduit. Subsequently, as the viscoelastic material continues to be injected from the visco syringe, the fluid pressure pushes the piston rod 788 away from the inlet 785 against the action of the spring 792 (connected to the piston rod 788 via the plate 790), and the pressurized viscoelastic material fills the chamber 766, as shown in Figure 12. Once filling is complete, the visco syringe is removed, and the one-way valve 787 prevents the viscoelastic material from flowing back through the inlet 785. The O-ring seal 791 prevents the viscoelastic material from leaking around the piston rod 788. When the visco trigger 762 of the delivery system 750 is toggled open again, the spring 792 moves the piston rod 788 back toward the inlet 785. Since the one-way valve 787 prevents the viscoelastic material from passing through the inlet 785, this movement of the piston rod 788 discharges the viscoelastic material from the chamber 766 into the passage 789, the tube 768, and the conduit in the cannula 754. After all the viscoelastic material has been delivered from chamber 766 through tube 768, the Visco module returns to the configuration shown in Figure 11.

[0055] The conduit advance wheel 764 is configured to advance and retract the conduit within the cannula 754 of the delivery system. The separate conduit advance wheel 764 allows the conduit to be moved within Schlemm's canal without administering viscoelastic material from the conduit. Similarly, the viscotriga 762 on the handle allows the viscoelastic material to be administered from the conduit into Schlemm's canal without moving the conduit.

[0056] Figure 13 shows one embodiment of a viscomodule 760, in which a partially transparent or translucent viscomodule body is fitted with a scale marking 794 to form a viscoelastic chamber gauge. A portion 795 of the body can be made opaque to conceal a spring 792. Figure 14 shows an embodiment of the viscomodule 760 with an integrated clip 796 added for attaching the viscomodule to an IV pole 995 (as shown in Figure 23), the user's wrist (as shown in Figure 22), or the user's clothing. In other embodiments, the clip 796 can be omitted, and a tube 768 ties the module 760 to the handle of the delivery system 750 so that the module 760 and the tube hang over the user's wrist. In embodiments, the tube 768 can be 3 to 4 inches long to enable this draping function. In various embodiments, the tube 768 can be formed from a high-pressure braided reinforced tube.

[0057] Figures 15–18 show alternative embodiments of the viscomodule 860. Similar to the embodiments described above, the viscomodule may incorporate a spring (e.g., a compression spring) that provides compression to a plunger to pressurize the flow of viscoelastic material within the viscomodule. In this embodiment, the viscomodule may include a Luer fitting 886 and a one-way check valve 887, similar to the embodiments in Figures 10–12. The passage 889 extends through a rod 802 to a viscore reservoir 894. The rod 802 extends from a compression knob 896, a threaded member 804 connected to the compression knob 896, a compression spring 892, and a piston 889. The outlet 895 from the viscore reservoir 894 is adapted to connect via a connector 893 to a tube (not shown) leading to a delivery system (not shown), such as the delivery system 750 described above. Reservoir 894 can be filled with viscoelastic material by connecting a visco syringe to a Luer fitting 886 using a visco module configured as shown in Figure 16. A visco delivery system is connected to the outlet of reservoir 894 via a tube, and when the visco delivery trigger of the visco delivery system is pushed to the open position, the viscoelastic material first fills reservoir 894, then flows through the tube, and flows through the delivery system to the conduit outlet port of the delivery system to prime the system. After toggling the visco delivery trigger of the delivery system to the closed position, the compression knob 896 can be turned to pressurize the viscoelastic material in the visco reservoir 894 of the visco module 860 so that the threaded member 804 advances into the housing 806 (which has corresponding threads). With the visco delivery trigger in the closed position, the viscoelastic material cannot flow out of reservoir 894, and the piston 889 remains in its withdrawn position when the threaded member 804 advances. The flange 808 at the end of the threaded member 804 compresses the spring 892 against the piston 889 as the threaded member advances, pressurizing the reservoir 894, as shown in Figure 17. The operator can then control the delivery of the viscoelastic material from the visco module 860 to the delivery system by, for example, deploying a visco trigger (such as the visco trigger 762 in Figure 10) on the delivery system connected to the visco module.As the viscoelastic material is delivered from the reservoir 894, the spring 892 moves the piston 889 toward the outlet 895 until the reservoir is depleted, as shown in Figure 18. In some embodiments, the reservoir portion of the housing 806, or all of the housing 806, may be transparent or translucent so that the amount of viscoelastic material it contains can be seen. Markings may be added to the housing to help quantify the amount of viscoelastic material delivered and / or the amount remaining in the housing.

[0058] Figure 19 shows a modification of the embodiments shown in Figures 15-18. In this embodiment, the visco inlet Luer fitting 886' and the one-way check valve 887' are located on the side of the housing 806' of the visco module 860'. A rod 802' extends between a threaded member 804' connected to a compression knob 896' and a piston 889'. A compression spring 892' also extends between the threaded member 804' and the piston 889'. The outlet 895' from the visco reservoir 894' is adapted to connect via a connector 893' to a tube (not shown) leading to a delivery system (not shown), such as the delivery system 750 described above. The reservoir 894' is a visco module configured as shown in Figure 19 and can be filled with viscoelastic material by, for example, connecting a visco syringe to the Luer fitting 886'. The visco delivery system is connected to the outlet of reservoir 894' via a tube, and when the visco delivery trigger of the visco delivery system is pushed to the open position, viscoelastic material first fills reservoir 894', then flows into the tube, through the delivery system, and flows to the conduit outlet port of the delivery system to prime the system. After toggling the visco delivery trigger of the delivery system to the closed position, the viscoelastic material in the visco reservoir 894' of the visco module 860' can be pressurized by turning the compression knob 896' so that the threaded member 804' advances into the housing 806' (which has corresponding threads). With the visco delivery trigger in the closed position, the viscoelastic material cannot flow out of reservoir 894', and the piston 889' remains in its withdrawn position as the threaded member 804' advances. The flange at the end of the threaded member 804' compresses the spring 892' against the piston 889' as the threaded member advances, pressurizing the reservoir 894'. Next, the operator can control the delivery of viscoelastic material from the visco module 860' to the delivery system by, for example, deploying a visco trigger (such as the visco trigger 762 in Figure 10) on the delivery system connected to the visco module. Once the viscoelastic material is delivered from the reservoir 894', the spring 892' moves the piston 889' toward the outlet 895' until the reservoir is depleted.In some embodiments, the reservoir portion of the housing 806', or the entirety of the housing 806', can be made transparent or translucent so that the amount of viscoelastic material it contains can be seen. Markings may be added to the housing to help quantify the amount of viscoelastic material delivered and / or the amount remaining in the housing.

[0059] Figures 20-21 show yet another embodiment of the Visco Module 1200 for use with, for example, the viscoelastic delivery system described herein. In this embodiment, the Visco inlet Luer fitting 1202 and the one-way check valve 1204 lead to the upper front inlet 1206 of the housing 1208 of the Visco Module 1200. The inlet 1206 extends from the check valve 1204 to the upper end of the tapered reservoir portion 1212 located at the end of the cylindrical reservoir portion 1214 of the reservoir 1210. The rod 1216 extends from the piston 1222 to the internal channel 1218 of the hollow rod 1219 extending from the compression knob 1220. The compression spring 1224 extends between one end of the rod 1219 and the piston 1222. The outlet 1225 at the tapered portion 1212 of the viscore reservoir 1210 is fitted to connect via a connector 1226 to a tube (not shown) leading to a delivery system (not shown), such as the delivery system 750 described above. An O-ring 1228 seals the piston against the inner wall of the reservoir 1210 to prevent the viscoelastic material from leaking around the piston.

[0060] By filling the reservoir 1210 with viscoelastic material (for example by connecting the Visco syringe to the Luer fitting 1202), the piston 1222 in the reservoir 1210 can be moved away from the inlet 1204 to the position shown in Figure 20, where the piston 1222 engages with the leading edge of the stop tube 1221, but the spring 1224 of the Visco module is not compressed (not shown), and the compression knob 1220 rotates away from the housing 1208 (also not shown), allowing the piston to move away from the inlet 1204 while the viscoelastic material is injected from the syringe. The Visco delivery system is connected to the outlet of the reservoir 1210 via a tube, and when the Visco delivery trigger of the Visco delivery system is pressed to the open position, the viscoelastic material first flows into the tapered portion 1212 of the reservoir, then into the tube connected to the connector 1226, and flows through the delivery system to the conduit outlet port of the delivery system to prime the system. Subsequently, as the piston is pushed back, additional viscoelastic material fills the rest of the reservoir. The location of the inlet 1206 just below the cylindrical portion 1214 of the reservoir causes the viscoelastic material to flow across the bottom surface 1223 of the piston 1222 at the start of the priming process when the piston is at the end of the cylindrical portion 1214 (as shown in Figure 21), thereby purging any air bubbles that may form and accumulate on the piston surface 1223 or the tapered portion 1212 of the reservoir.

[0061] After toggling the Visco delivery trigger of the delivery system to the closed position, the viscoelastic material in the Visco reservoir 1210 of the Visco module 1200 can be pressurized by turning the compression knob 1220 so that the hollow rod 1219 advances beyond the rod 1216 into the housing 1208 (which has a corresponding thread). With the Visco delivery trigger in the closed position, the viscoelastic material cannot flow out of the reservoir 1210, and the piston 1222 remains in its withdrawn position as the rod 1219 advances, thereby compressing the spring 1224 and pressurizing the reservoir 1210, as shown in Figure 20. The operator can then control the delivery of the viscoelastic material from the Visco module 1200 to the delivery system by, for example, deploying a Visco trigger on the delivery system connected to the Visco module (such as the Visco trigger 762 in Figure 10). As the viscoelastic material is delivered from the reservoir 1200, the spring 1224 moves the piston 1222 toward the outlet 1225 until the piston reaches the end of its range of motion, as shown in Figure 21. In some embodiments, the reservoir portion of the housing 1208, or all of the housing 1208, can be made transparent or translucent so that the amount of viscoelastic material it contains can be seen. Markings may be added to the housing to help quantify the amount of viscoelastic material delivered and / or the amount remaining in the housing.

[0062] Figures 24–28 show various diagrams of the viscoelastic delivery system 1050 as discussed herein. As described above, the delivery system may include a visco trigger 1062 supported by a handle 1052 and a conduit advance wheel 1064. The cannula 1054 extends from the distal end of the handle 1052. The cannula 1054 has an internal passage and a distal opening configured to be in fluid communication with a Schlemm tube. Referring to Figure 25, the conduit advance wheel 1064 may include a plurality of notches 1098. This wheel may be coupled to a rack and pinion mechanism 1099 coupled to the conduit 1053 (e.g., formed from a Vestamid® ML21 nylon extruded product) to control the advancement of the conduit 1053 within the cannula 1054.

[0063] In some embodiments, the gears of the rack and pinion system can be optimized to advance the conduit by a set distance for each notch 1098 of the conduit advance wheel 1064. For example, in one embodiment, the notches can be spaced 3 mm apart, and a 1:1 gear ratio can be used in the rack and pinion system so that the advance of the conduit advance wheel by one notch advances the conduit by 3 mm. In alternative embodiments, other gear ratios can be used. For example, a 2:1 gear ratio can be used to advance the conduit by 6 mm when the spacing between notches is 3 mm.

[0064] As shown in Figures 26-27, a cantilever spring 1065, formed from wire or as a molded plastic bar, slides along a ridge of the notched conduit advance wheel 1064, providing the user with tactile feedback to know exactly how far the conduit is advancing into the Schlemm tube as the wheel rotates, and letting the user know where the viscoelastic material is being injected relative to the cannula tip. Figure 30 shows an alternative conduit advance wheel 1064' and an alternative cantilever spring 1065' that slides in and out of a recess 1067 on the side of the wheel 1064' to provide tactile feedback. Figure 31 shows yet another alternative advance wheel 1064'' having a recess 1067'' and a cantilever spring 1065'' for tactile feedback of conduit advancement.

[0065] In some embodiments, the rack and pinion mechanism 1099 is configured to move 24 mm. In the fully retracted configuration, 24 mm of the conduit 1053 lies within the handle 1052, and the conduit lies within the straight portion of the cannula 1054 proximal to the distal curved portion of the cannula. The conduit can be maintained in this configuration during shipping and / or storage so that it does not take a curved set from the curved portion of the cannula. A 24 mm rack movement to the most extended configuration results in a 20 mm extension of the conduit from the cannula.

[0066] Next, with reference to Figures 25-28, we consider the operation of the Viscotrigger 1062. As described above, the Viscotrigger 1062 may be equipped with a simple toggle lever that can alternately switch between an off and on state. When the Viscotrigger is in the off state, the delivery system 1050 does not deliver a flow of viscoelastic material through the conduit in the cannula. In contrast, when the Viscotrigger is moved to the on state, a flow of viscoelastic material is allowed to flow from the Viscomodule (described above) through the toggle valve 1001 into the conduit / cannula of the delivery system. Therefore, the amount of viscoelastic material delivered from the delivery system correlates with the length of time the Viscotrigger is in the on state.

[0067] Referring to Figures 26-28, the shaft 1003 is positioned offset from the rotation axis 1063 of the visco trigger 1062, and the distal end of the shaft 1003 is positioned within the groove 1061 of the visco trigger 1062. The distal end 1004 of the shaft 1003 slides within the groove 1061 as the trigger 1062 moves. The distal end 1004 of the shaft 1003 may be convex or flat, as shown in Figure 28. The offset position of the shaft 1003 relative to the rotation axis of the trigger 1062 causes the shaft 1003 to move back and forth along its longitudinal axis, thereby compressing the spring 1005 and moving the position of one or more O-rings 1007 within the toggle valve 1001. The movement of the O-ring 1007 opens the valve, allowing a pressurized flow of viscoelastic material to flow from the Visco module (described above) through tube 1010 to the valve inlet 1009 and out through the valve outlet (not shown) to tube 1012 leading to conduit 1053. (Figure 26 omits most of tubes 1010 and 1012 for clarity. Similarly, Figure 28 shows the valve outlet 1011 with tube 1012 omitted for clarity). When the user's operating force is released from the Visco trigger, the spring 1005 depressurizes, returning the shaft 1003 and O-ring 1007 to their positions, turning the Visco trigger 1062 back to the off position, closing the valve, and effectively stopping the flow of pressurized viscoelastic material.

[0068] Tube 1012 extends from the valve outlet beyond the side stress relief element 1002 of the toggle valve 1001. Tube 1012 forms a loop within the handle 1052 when the rack and pinion are in their most retracted position, as shown in Figure 27, and extends straight as the conduit advances. Figure 29 shows a stress relief element 1002' with an alternative shape.

[0069] Figures 32-34 show other alternative embodiments of some components of the viscoelastic delivery system shown in Figures 24-28. In one embodiment, the visco trigger 1362 of the delivery system has a modified shape. As described above, the visco trigger 1362 can be a simple toggle lever which can be switched alternately between an off and an on state. When the visco trigger is in the off state, the delivery system 1050 does not deliver a flow of viscoelastic material through the conduit in the cannula. In contrast, when an actuation force is applied to the visco trigger, the visco trigger moves backward to the on state (as shown in Figures 32-34), and a flow of viscoelastic material flows from the visco module (described above) through the toggle valve 1301 into the conduit / cannula of the delivery system. Specifically, the backward movement of the visco trigger 1362 moves the shaft 1306 against the action of the spring 1304, disengaging the ball valve 1305 from its seat on the O-ring 1303 (as shown in Figure 32, which shows the valve housing 1310 in a transparent state), thereby allowing the pressurized viscoelastic material to flow into the valve housing 1310 and out into the tube 1012, which leads to a conduit (not shown) of the delivery system. When the operating force is removed, the visco trigger 1362 returns to the off position, and the spring 1304 depressurizes, returning the ball valve 1305 to its seat on the O-ring 1303, closing the valve and effectively stopping the flow of the pressurized viscoelastic material. The components of the valve housing 1310 may be bonded to each other. An opening 1312 may be formed in the valve housing 1310 to facilitate adhesive injection.

[0070] The visco trigger may be a simple lever such as the toggle lever 1062 in Figure 28 or the toggle lever 1362 in Figures 32-34, or alternatively, it may have an angled shape such as the toggle lever 1362' shown in Figure 35. The visco triggers 1062, 1362, and 1362' may be formed from plastic (e.g., PEEK), stainless steel, or any other suitable material.

[0071] Figure 36 shows a toggle lock 1340 that maintains the Visco trigger 1362 in the rearward (open) position during priming. The toggle lock 1340 can be removed from the handle 1052 by pulling the tab 1341 upward after priming and before pressurizing the Visco cartridge (for example, by turning the compression knob 1220 in the embodiment of Figure 20) and treating the patient using the viscoelastic delivery system. Figure 37 shows an alternative toggle lock 1340' with a larger tab 1341' to facilitate its removal from the handle 1052.

[0072] Figures 38 and 39 show details of the distal end of the cannula 1054 of the viscoelastic delivery system, which has a chamfered tip 1055. The tip 1055 is not sharp enough to puncture or shear the conduit 1053 (not shown in Figure 38) when entering and exiting the cannula 1054, but can be electropolished to be sharp enough to puncture the trabecular reticular tissue during treatment. As shown in Figure 39, the tip 1055 has two flat surfaces 1056 and 1057 at its distal end, formed, for example, by grinding an angled surface 1058.

[0073] Figures 40–44 show how a curved cannula 1054 extending from a handle 1052 can be rotated by a known amount relative to the handle. The cannula 1054 is welded to a rotatable hub 1402 extending from the distal end of the handle 1052, with the angled tip of the cannula directed towards one of two notches 1403 in the hub 1402. The barrel 1404 extends around the hub 1402. The barrel 1404 has a groove 1408 at its proximal open end 1409 that rests against an O-ring 1410 on the handle. The lock plug 1412 is positioned with its proximal-facing surface against the distal-facing surface 1407 surrounding the distal opening 1406 of the barrel 1404 in order to connect the barrel 1404 to the hub 1402 so that the barrel 1404, hub 1402, and cannula 1054 rotate together. Two legs 1414 extend proximal to the lock plug 1412 through a notch 1403. The tabs 1416 of the legs 1414 engage with the proximal-facing surface of the hub 1402 to press the barrel proximal to the O-ring 1410, and the ridges 1418 of the legs 1414 engage with the corresponding grooves 1420 on the inside of the barrel 1404. The cannula 1054 extends through the distal opening 1406 of the barrel 1404 and through the opening 1422 of the lock plug 1412. When assembled, the outer line 1424 of the barrel 1404 fits snugly with the radial direction from which the angled tip of 1054 extends. By orienting line 1424 using graduated "clock time" markings and / or numerals 1426 on handle 1052, the user can know the orientation of the curved tip of cannula 1054, even when the cannula itself is not easily visible, for example, when the cannula is inserted into the patient's eye. The O-ring 1410 provides friction to resist the free movement of barrel 1404 in order to hold the barrel / hub / cannula assembly in its rotational position. Barrel 1404 may have grooves, ridges or notches 1405 for easier gripping.

[0074] The system described herein provides a novel and unique viscoelastic delivery system. The delivery system itself includes separate triggers or mechanisms for deploying or administering a viscoelastic material from the delivery system into the eye, and for controlling the location from which the viscoelastic material is deployed (via a conduit). Methods of use can also be provided herein.

[0075] Referring to Figure 45, a flowchart is provided describing a method for treating a patient's eye using an ophthalmic system. This method may include the following steps:

[0076] In operation 1102 of Figure 45, the method may include inserting the distal end of the cannula of the ophthalmic system into the anterior chamber of the eye. In some embodiments, the cannula may be inserted into the anterior chamber through an incision in the eye. In other embodiments, the cannula may enter the anterior chamber by piercing the eye with its distal tip.

[0077] In operation 1104, the method may further include positioning the distal end of the cannula in fluid communication with the Schlemm's canal such that the cannula enters the Schlemm's canal substantially tangentially.

[0078] In operation 1106, the method may further include activating a first control unit of the ophthalmic system to advance the conduit from the cannula into Schlemm's canal. The first control unit may also further advance and retract the conduit within Schlemm's canal, allowing the conduit to be fully retracted into the cannula. As described above, the delivery system may include a viscoelastic advance wheel configured to move the conduit of the delivery system within the cannula. The conduit may be moved distally from the cannula, for example, so that it extends partially beyond the distal opening of the cannula. Alternatively, the conduit may be moved proximal to the distal end of the cannula. Adjusting the position of the conduit relative to the cannula can be used to adjust the position of the viscoelastic delivery port of the conduit. In one example, the viscoelastic delivery port includes an opening at the distal end of the conduit. The viscoelastic delivery port may be configured to deliver a flow of viscoelastic material into a tissue or body structure. In some embodiments, the first control unit may be a control wheel, lever, switch, button, etc., located on the handle of the ophthalmic system. In other embodiments, the first control unit may be located away from the system's handle (e.g., a foot switch). The first control unit may include physical features such as detents and notches to provide the user with tactile feedback on how far the conduit has moved forward or backward.

[0079] In operation 1108, the method may further include activating a second control unit of the ophthalmic system to administer a viscoelastic material into the conduit and Schlemm's canal. In some embodiments, the second control unit may be a control wheel, lever, switch, button, etc., located on the handle of the ophthalmic system. The first and second control units may be adjacent to each other, or may be positioned on the handle so that the user can operate both the first and second control units. In some embodiments, the second control unit may be located away from the handle (for example, on the viscoelastic module).

[0080] The second control unit may include an on / off switch, in which case the viscoelastic material flows out of the conduit in the on position and does not flow out in the off position. In other embodiments, the second control unit can deposit a known volume of viscoelastic material into the Schlemm tube. The second control unit gives the user control over how much viscoelastic material is delivered to the Schlemm tube. In some examples, a consistent bolus or amount of viscoelastic material can be injected into the Schlemm tube each time the position of the viscoelastic material delivery port is adjusted. In some embodiments, a larger amount of viscoelastic material can be administered when desired. The position of the conduit, and thus the position of the viscoelastic material delivery port, can be controlled by the user independently of the administration of viscoelastic material (e.g., via the first and second control units, respectively).

[0081] In some embodiments, the viscoelastic material may be administered before delivery of the ophthalmic implant to open the aqueous humor outflow pathway. In other embodiments, the viscoelastic material may be administered after the ophthalmic implant has been placed in Schlemm's canal.

[0082] Numerous features of various embodiments are described above, along with details of the structure and function of various embodiments. However, this detailed description is illustrative only, and it should be understood that modifications may be made to the extent of the broad general meaning of the terms used in the appended claims, particularly with respect to the structure and arrangement of the parts shown by various embodiments. According to embodiment (1), a method for treating a patient's eye using an ophthalmic system, The steps include inserting the distal end of the cannula of the ophthalmic system into the anterior chamber of the eye, The step of arranging the cannula so as to be in fluid communication with Schlemm's tube, wherein the conduit is located inside the cannula. The steps include: activating the first control unit of the ophthalmic system to advance the conduit from the cannula into Schlemm's canal; The steps include: activating the second control unit of the ophthalmic system to administer a viscoelastic material into Schlemm's canal from the viscoelastic material delivery port of the conduit without moving the conduit; This method includes [something]. According to embodiment (2), the step of operating the first control unit to retract the conduit into Schlemm's tube and into the cannula is further included. According to embodiment (3), the step of pressurizing the volume of viscoelastic material in a viscoelastic module, the step of activating the second control unit, includes activating the second control unit of the ophthalmic system to administer the viscoelastic material from the viscoelastic module into the conduit. According to embodiment (4), the ophthalmic system comprises a handle, the cannula, the first control unit, and the second control unit each extend from and are supported by the handle, and the viscoelastic module is located outside the handle. According to embodiment (5), the step of pressurizing the volume of the viscoelastic material includes the step of applying a spring to the plunger of a viscoelastic syringe disposed within the viscoelastic module. According to embodiment (6), the step of pressurizing the volume of the viscoelastic material includes the step of pressurizing the reservoir in the viscoelastic module. According to embodiment (7), the step of pressurizing the reservoir includes the step of compressing a spring engaged with the wall of the reservoir. According to embodiment (8), the step of compressing the spring includes the step of operating an actuator extending from the viscoelastic module. According to embodiment (9), the method further includes the step of filling the reservoir with a viscoelastic material from a viscoelastic syringe. According to embodiment (10), the further step includes advancing the viscoelastic material from the viscoelastic syringe into the conduit. According to embodiment (11), the step of advancing the viscoelastic material from the viscoelastic syringe into the conduit is performed before the step of filling the reservoir with the viscoelastic material from the viscoelastic syringe. According to embodiment (12), the further step includes providing tactile feedback while operating the first control unit, wherein the tactile feedback correlates with the length of the conduit moving in or out of the cannula. According to embodiment (13), the further step includes advancing the ophthalmic implant into Schlemm's canal before the viscoelastic material is administered into Schlemm's canal. According to embodiment (14), the method further includes the step of advancing an ophthalmic implant into Schlemm's canal after the viscoelastic material has been administered to Schlemm's canal. According to embodiment (15), an ophthalmic viscoelastic material delivery system, The handlebars and A cannula that defines a passage extending from the handle to the distal cannula opening, the cannula being advanced through the anterior chamber of the patient's eye and sized to position the distal cannula opening in fluid communication with Schlemm's canal of the eye, A conduit slidably disposed within the cannula passage, including a viscoelastic delivery port, wherein at least the distal portion of the conduit is sized to advance forward from the cannula into Schlemm's canal, and the conduit comprises A viscoelastic module having fluid communication with the conduit and the viscoelastic delivery port, the viscoelastic module being configured to include a pressurized volume of viscoelastic material outside the handle, A first control unit configured to adjust the position of the conduit and the viscoelastic material delivery port relative to the cannula, A second control unit configured to discharge pressurized viscoelastic material from the viscoelastic module into the Schlemm tube through the conduit and the viscoelastic material delivery port, and This is an ophthalmic viscoelastic material delivery system that includes [specific components / materials]. According to embodiment (16), the viscoelastic module is A cradle configured to receive a viscoelastic syringe, A force assembly configured to contact the plunger of the viscoelastic syringe, further configured to apply a constant force to the plunger; It also includes. According to embodiment (17), the force assembly further includes an adjustment mechanism configured to adjust the position of the force assembly relative to the plunger. According to embodiment (18), the viscoelastic module includes a reservoir and a spring configured to pressurize the viscoelastic material in the reservoir. According to embodiment (19), the present invention further includes an actuator extending from the viscoelastic module and configured to compress the spring in order to pressurize the reservoir. According to embodiment (20), the viscoelastic module further includes an inlet port adapted to engage with a viscoelastic syringe, wherein the inlet port is a fluid capable of fluid communication with the reservoir. According to embodiment (21), the invention further includes a check valve positioned between the inlet port and the reservoir, the check valve being configured to open to allow pressurized viscoelastic material to flow from the viscoelastic syringe through the inlet port to the reservoir, and to close to prevent viscoelastic material from flowing out of the reservoir through the inlet port. According to embodiment (22), the first control unit and the second control unit are arranged on the handle. According to embodiment (23), a single operation of the first control unit moves the conduit by a known distance. According to embodiment (24), the device further includes a cantilever spring that engages with the first control unit and is adapted to provide tactile feedback of the movement of the first control unit. According to embodiment (25), a single operation of the second control unit administers a known amount of viscoelastic material from the conduit and the viscoelastic material delivery port to the Schlemm tube. According to embodiment (26), the second control unit includes a toggle lever operable to move to a first position to open a valve to deliver viscoelastic material from the viscoelastic module into the conduit, and the second control unit further includes a spring operable to move the toggle to a second position to close the valve. According to embodiment (27), the invention further includes a toggle lock configured to hold the toggle lever in the first position. According to embodiment (28), the toggle lock is detachably disposed on the outer surface of the handle and engages with the toggle lever. According to embodiment (29), the invention further includes a tube extending from the viscoelastic module to the handle, the tube comprising a fluid lumen extending from the outlet of the viscoelastic module to the inlet control unit in the handle. According to embodiment (30), the tube has a length of 3 to 4 inches. According to embodiment (31), an ophthalmic delivery system, The handlebars and A hub positioned at the distal end of the handle and configured to be rotatable relative to the handle, A cannula configured to be coupled to the hub and to rotate with the hub, having a defined passage extending from the handle to the distal cannula opening, being advanced through the anterior chamber of the patient's eye, and sized to position the distal cannula opening in fluid communication with Schlemm's canal of the eye, and having a curved distal end, A cannula orientation marking that is rotatable with the hub and visible from the outside of the delivery system, and which is aligned with the radial direction in which the distal end of the cannula curve extends, A fixing marking supported by the handle, wherein the cannula orientation marking and the fixing marking together indicate the orientation of the distal end of the curved cannula relative to the orientation of the handle. This is an ophthalmic delivery system that includes [the necessary components]. According to embodiment (32), the present invention further includes a conduit slidably disposed within the cannula passage, comprising a viscoelastic material delivery port, wherein at least the distal portion of the conduit is sized to advance forward from the cannula into Schlemm's canal, and a reservoir adapted for delivering a viscoelastic material into the conduit. According to embodiment (33), the system further includes a control unit configured to adjust the position of the conduit and the viscoelastic material delivery port relative to the cannula. According to embodiment (34), the device further includes a control unit configured to discharge a pressurized viscoelastic material from the reservoir through the conduit and the viscoelastic material delivery port into a Schlemm tube.

Claims

1. An ophthalmic viscoelastic material delivery system, The handlebars and A cannula that defines a passage extending from the handle to the distal cannula opening, the cannula being advanced through the anterior chamber of the patient's eye and sized to position the distal cannula opening in fluid communication with Schlemm's canal of the eye, A conduit slidably disposed within the passage of the cannula, comprising a viscoelastic delivery port, wherein at least the distal portion of the conduit is sized to advance forward from the cannula into Schlemm's canal, and the conduit and A viscoelastic module having fluid communication with the conduit and the viscoelastic delivery port, the viscoelastic module being configured to include a pressurized volume of viscoelastic material outside the handle, A first control unit configured to adjust the position of the conduit and the viscoelastic material delivery port relative to the cannula, A second control unit configured to discharge pressurized viscoelastic material from the viscoelastic module into the Schlemm tube through the conduit and the viscoelastic material delivery port, and Includes, The first control unit and the second control unit are arranged on the handle. Ophthalmic viscoelastic material delivery system.

2. The viscoelastic module, A cradle configured to receive a viscoelastic syringe, A force assembly configured to contact the plunger of the viscoelastic syringe, further configured to apply a constant force to the plunger; The delivery system according to claim 1, further comprising:

3. The system according to claim 2, further comprising an adjustment mechanism configured to adjust the position of the force assembly relative to the plunger.

4. The system according to claim 1, wherein the viscoelastic module includes a reservoir and a spring configured to pressurize the viscoelastic material in the reservoir.

5. The system according to claim 4, further comprising an actuator extending from the viscoelastic module and configured to compress the spring to pressurize the reservoir.

6. The system according to claim 4, wherein the viscoelastic module further includes an inlet port adapted to engage with a viscoelastic syringe, the inlet port being able to communicate fluidly with the reservoir.

7. The system according to claim 6, further comprising a check valve positioned between the inlet port and the reservoir, the check valve being configured to open to allow pressurized viscoelastic material to flow from the viscoelastic syringe through the inlet port to the reservoir, and to close to prevent viscoelastic material from flowing out of the reservoir through the inlet port.

8. The system according to claim 1, wherein a single operation of the first control unit moves the conduit by a known distance.

9. The system according to claim 1, further comprising a cantilever spring that engages with the first control unit and is adapted to provide tactile feedback of the movement of the first control unit.

10. The system according to claim 1, wherein a single operation of the second control unit administers a known amount of viscoelastic material from the conduit and the viscoelastic material delivery port to the Schlemm tube.

11. The system according to claim 1, wherein the second control unit includes a toggle lever operable to move to a first position to open a valve to deliver viscoelastic material from the viscoelastic module into the conduit, and the second control unit further includes a spring operable to move the toggle lever to a second position to close the valve.

12. The system according to claim 11, further comprising a toggle lock configured to hold the toggle lever in the first position.

13. The system according to claim 12, wherein the toggle lock is detachably disposed on the outer surface of the handle and engages with the toggle lever.

14. The system according to claim 1, further comprising a tube extending from the viscoelastic module to the handle, wherein the tube includes a fluid lumen extending from the outlet of the viscoelastic module to an inlet control unit in the handle.

15. The system according to claim 14, wherein the tube has a length of 3 to 4 inches.

16. An ophthalmic delivery system, The handlebars and A hub positioned at the distal end of the handle and configured to be rotatable relative to the handle, A cannula configured to be coupled to the hub and to rotate with the hub, having a defined passage extending from the handle to the distal cannula opening, being advanced through the anterior chamber of the patient's eye, and sized to position the distal cannula opening in fluid communication with Schlemm's canal of the eye, and having a curved distal end, A cannula orientation marking that is rotatable with the hub and visible from the outside of the ophthalmic delivery system, and which is aligned with the radial direction in which the curved distal end of the cannula extends, A fixing marking supported by the handle, wherein the cannula orientation marking and the fixing marking together indicate the orientation of the curved distal end of the cannula relative to the orientation of the handle, A conduit slidably disposed within the passage of the cannula, including a viscoelastic delivery port, wherein at least the distal portion of the conduit is sized to advance forward from the cannula into Schlemm's canal, A reservoir adapted to deliver a viscoelastic material into the conduit, A first control unit configured to adjust the position of the conduit and the viscoelastic material delivery port relative to the cannula, A second control unit configured to discharge pressurized viscoelastic material from the reservoir through the conduit and the viscoelastic material delivery port into a Schlemm tube, Includes, The first control unit and the second control unit are arranged on the handle. Ophthalmic delivery system.

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