CN116669659A - Systems and methods for viscoelastic delivery - Google Patents

Abstract

Methods and apparatus for reducing intraocular pressure in a patient. The method may include deploying and applying a viscoelastic material into schlemm's canal to open an aqueous outflow path. The apparatus is adapted to perform the method. The viscoelastic material may be configured to reduce intraocular pressure within the eye.

Description

Systems and methods for viscoelastic delivery

Cross Reference to Related Applications

The present application claims the benefit of priority from U.S. provisional application number 63/136,148 filed on day 1, month 11 of 2021 and U.S. provisional application number 63/236,598 filed on day 8, 2021, each of which is incorporated herein by reference in its entirety.

Incorporated by reference

All publications and patent applications mentioned in this specification are herein 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.

Technical Field

The present disclosure relates generally to, but is not limited to, medical devices and methods for manufacturing medical devices. The present application relates generally to devices and systems for insertion into an eye. More particularly, the present application relates to devices that facilitate the transfer of fluid from one region of the eye to another region of the eye. In addition, the present disclosure relates to systems, devices, and methods for injecting a viscoelastic material into Schlemm's canal to open an aqueous outflow pathway.

Background

According to the report draft by the national institute of ophthalmology (National Eye Institute, NEI) of the national institutes of health (The United States National Institutes of Health, NIH), glaucoma is now the leading cause of irreversible blindness worldwide and the second leading cause of blindness next to cataracts worldwide. Thus, the NEI report draft concludes that it is "vital that sufficient attention and resources continue to be devoted to determining the pathophysiology and management of this disease. "glaucoma researchers have found a strong correlation between high intraocular pressure and glaucoma. For this reason, ophthalmic care professionals typically screen glaucoma patients by measuring intraocular pressure using a device called a tonometer. Many modern tonometers make this measurement by blowing a sudden jet of air against the outer surface of the eye.

The eye can be conceptualized as a fluid-filled sphere. There are two types of fluids within the eye. The cavity behind the lens is filled with a viscous fluid called vitreous humor. The anterior chamber of the lens is filled with a fluid called aqueous humor. Each time a person views an object, he or she views the object through the vitreous humor and aqueous humor.

Whenever a person views an object, he or she also views the object through the cornea and lens of the eye. For transparency, the cornea and lens may not include blood vessels. Accordingly, no blood flows through the cornea and lens to provide nutrition to these tissues and remove waste products from these tissues. Alternatively, these functions are performed by aqueous humor. The continuous flow of aqueous humor through the eye provides nutrition to the non-vascular portions of the eye (e.g., the cornea and lens). This flow of aqueous humor also removes waste from these tissues.

Aqueous humor is produced by an organ called the ciliary body. The ciliary body includes epithelial cells that continuously secrete aqueous humor. In a healthy eye, as new aqueous humor is secreted by the epithelial cells of the ciliary body, aqueous humor flows out of the anterior chamber of the eye through the trabecular meshwork and into schlemm's canal. This excess aqueous humor enters the venous blood stream from schlemm's canal and leaves the eye with the venous blood.

When the natural drainage mechanism of the eye ceases to function properly, the pressure within the eye begins to rise. Researchers speculate that prolonged exposure to high intraocular pressure can lead to damage to the optic nerve that conveys sensory information from the eye to the brain. This damage to the optic nerve results in loss of peripheral vision. As glaucoma progresses, more and more fields of view are lost until the patient is totally blind.

Disclosure of Invention

The present invention provides designs, materials, and methods of use for medical devices.

An illustrative method for reducing intraocular pressure in a patient may include applying a viscoelastic material to schlemm's canal of an eye to open an aqueous outflow path. In some embodiments, the viscoelastic may be administered before or after deployment of the ocular implant into schlemm's canal.

One aspect of the invention provides a method of treating an eye of a patient with an ocular system. In some embodiments, the method comprises the steps of: inserting a distal end of a cannula of an ocular system into an anterior chamber of an eye; placing the cannula in communication with the scleral vein Dou Liuti, the catheter being disposed within the cannula; actuating a first control device of the ocular system to advance the catheter from the cannula into schlemm's canal; and actuating a second control device of the ocular system to administer the viscoelastic material from the viscoelastic delivery port of the catheter into schlemm's canal without moving the catheter. In some embodiments, the method further comprises the step of actuating the first control device to retract the catheter within schlemm's canal and advance the catheter into the cannula.

In some embodiments, the method may include the step of pressurizing a volume of viscoelastic material within the viscoelastic module, wherein the step of actuating the second control device includes: a second control device of the ocular system is actuated to apply the viscoelastic material from the viscoelastic module into the catheter. In some such embodiments, the ocular system may have a handle, the cannula, the first control device, and the second control device each extending from and being supported by the handle, wherein the viscoelastic module is disposed external to the handle. In some embodiments, the step of pressurizing the volume of viscoelastic material may include the additional step of applying a spring to a plunger of a viscoelastic syringe disposed within the viscoelastic module.

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

Some embodiments include the additional step of filling the reservoir with a viscoelastic material for a self-adhesive elastomeric syringe. Some such embodiments include the additional step of pushing the viscoelastic material from the viscoelastic syringe into the catheter, optionally prior to the step of filling the reservoir with viscoelastic material from the viscoelastic syringe.

Some embodiments have the additional step of providing tactile feedback associated with the length of the catheter being moved into or out of the cannula while the first control device is actuated.

Some embodiments of the method further comprise the step of advancing the ocular implant into schlemm's canal prior to administering the viscoelastic material into schlemm's canal. Some embodiments may further comprise the step of advancing the ocular implant into schlemm's canal after the viscoelastic material is administered into schlemm's canal.

Another aspect of the invention provides an ocular viscoelastic delivery system having: a handle; a cannula defining a passageway extending from the handle to a distal cannula opening, the cannula being sized and configured to be advanced through an anterior chamber of an eye of a patient to place the distal cannula opening in communication with a scleral vein Dou Liuti of the eye; a catheter slidably disposed within the cannula passageway, the catheter including a viscoelastic delivery port, at least a distal portion of the catheter being sized and configured to be advanced from the cannula into schlemm's canal; a viscoelastic module in fluid communication with the catheter and the viscoelastic delivery port, the viscoelastic module configured to contain a pressurized volume of viscoelastic material external to the handle; a first control device configured to adjust the position of the catheter and the viscoelastic delivery port relative to the cannula; and a second control device configured to release the pressurized viscoelastic material from the viscoelastic module into schlemm's canal through the catheter and the viscoelastic delivery port.

In some embodiments of the delivery system, the viscoelastic module further comprises a carrier configured to receive the viscoelastic syringe and a force assembly configured to contact the plunger of the viscoelastic syringe, the force assembly further configured to apply a constant force to the plunger. In some such embodiments, the force assembly further has an adjustment mechanism configured to adjust the position of the force assembly relative to the plunger.

In some embodiments, the viscoelastic module force assembly has a reservoir and a spring configured to pressurize the viscoelastic material in the reservoir. Some such embodiments also have an actuator extending from the viscoelastic module and configured to compress the spring to pressurize the reservoir.

In some embodiments, the viscoelastic module further has an inlet port adapted to engage with a viscoelastic injector, the inlet port being a fluid that is in fluid communication with the reservoir. In some such embodiments, the viscoelastic module further has a check valve disposed between the inlet port and the reservoir, the check valve 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 inlet port from the reservoir.

In some embodiments, the first control device and the second control device are disposed on the handle. In some embodiments, a single actuation of the first control device moves the catheter a known distance, and in some embodiments, a single actuation of the second control device applies a known volume of viscoelastic material from the catheter and the viscoelastic delivery port into schlemm's canal. Some embodiments provide a cantilever spring engaged with the first control and adapted to provide tactile feedback of movement of the first control.

In some embodiments, the second control device comprises a tap lever operable to move to a first position to open the valve to deliver viscoelastic material from the viscoelastic module into the catheter, the second control device further comprising a spring operable to move the tap to a second position to close the valve. Some such embodiments also have a toggle lock configured to retain the toggle lever in the first position. The toggle lock may be removably disposed on an outer surface of the handle and engaged with the toggle lever.

In some embodiments, the delivery system further has a tube extending from the viscoelastic module to the handle, the tube having a fluid lumen extending from an outlet of the viscoelastic module to an inlet control device in the handle. The tube may have a length of 3-4 inches.

Yet another aspect of the invention provides an ocular delivery system comprising: a handle; a hub disposed at a 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, the cannula defining a passageway extending from the handle to a distal cannula opening, the cannula sized and configured to be advanced through an anterior chamber of a patient's eye to place the distal cannula opening in communication with a scleral vein Dou Liuti of the eye, the cannula having a curved distal end; a cannula orientation marker rotatable with the hub and visible from outside the delivery system, the marker aligned with a radial direction in which the curved distal end of the cannula extends; and a fixation mark supported by the handle, the cannula orientation mark and the fixation mark together indicating an orientation of the curved distal end of the cannula relative to an orientation of the handle.

In some embodiments, the system further has a catheter slidably disposed within the cannula passageway, the catheter including a viscoelastic delivery port, at least a distal portion of the catheter being sized and configured to be advanced from the cannula into schlemm's canal, and a reservoir adapted to deliver a viscoelastic material into the catheter. In some such embodiments, the system has a control device configured to adjust the position of the catheter and the viscoelastic delivery port relative to the cannula. In some embodiments, the system has a control device configured to release the pressurized viscoelastic material from the reservoir into schlemm's canal through the catheter and the viscoelastic delivery port.

The above summary of some examples and embodiments is not intended to describe each disclosed embodiment or every implementation of the present disclosure. The following description of the drawings and detailed description more particularly exemplify these embodiments, but are also intended to be illustrative and not limiting.

Drawings

The disclosure may be more completely understood in consideration of the following detailed description of various embodiments in connection with the accompanying drawings, in which:

fig. 1 is a stylized perspective view depicting a portion of a human eye and a portion of an ocular implant disposed in schlemm's canal.

FIG. 2 is a stylized representation of a medical procedure according to the present disclosure.

Fig. 3 is an enlarged perspective view further showing the delivery system and the patient's eye.

Fig. 4 illustrates one example of a cannula of a delivery system including a catheter and a viscoelastic delivery port.

Fig. 5 is a perspective view showing one embodiment of a viscoelastic delivery system.

Fig. 6 is a partial cross-sectional and partial side view of a viscoelastic module showing the viscoelastic delivery system in an open, unpressurized configuration.

FIG. 7 is a partial cross-sectional and partial side view of the viscoelastic module of FIG. 6 shown in a closed, pressurized configuration.

Fig. 8 is a perspective view illustrating the viscous syringe loaded into the viscoelastic module of fig. 6 to 7.

Fig. 9 is a perspective view illustrating the viscous syringe loaded into the viscoelastic module of fig. 6 to 8.

Fig. 10 is a perspective view showing another embodiment of a viscoelastic delivery system.

Fig. 11 is a side cross-sectional view showing details of a viscoelastic module of the viscoelastic delivery system of fig. 10.

FIG. 12 is a side cross-sectional view of the viscoelastic module of FIG. 11, showing the reservoir fully loaded with viscoelastic material.

FIG. 13 is a perspective view illustrating an embodiment of a viscoelastic module having a partially see-through housing and scale markings.

Fig. 14 is a perspective view showing the viscoelastic module of fig. 13 with a clip for attaching the module to, for example, a user's wrist or arm or pole.

Fig. 15 is a side view of yet another embodiment of a viscoelastic module of a viscoelastic delivery system.

FIG. 16 is a cross-sectional view of the viscoelastic module of FIG. 15 in a pre-filled configuration.

Fig. 17 is a cross-sectional view of the viscoelastic module of fig. 15-16 in a filled and pressurized configuration.

Fig. 18 is a cross-sectional view of the viscoelastic module of fig. 15-17 in a emptied configuration.

Fig. 19 is a partial cross-sectional view showing a modification of the embodiment of fig. 15 to 18.

Fig. 20 is a cross-sectional view of yet another embodiment of a viscoelastic module showing a viscoelastic delivery system.

Fig. 21 is a cross-sectional view showing details of the viscoelastic module of fig. 20.

Fig. 22 is a perspective view of a viscoelastic delivery system showing a viscoelastic module (such as the viscoelastic module shown in fig. 14) attached to a user's arm.

Fig. 23 is a perspective view of a viscoelastic delivery system showing a viscoelastic module (such as the viscoelastic module shown in fig. 14) attached to an IV stent.

Fig. 24 is a perspective view of a viscoelastic delivery system including a first control device and a second control device configured to control delivery of a viscoelastic material and adjustment of a position of a catheter relative to a cannula, in accordance with an embodiment of the invention.

Fig. 25 is a cross-sectional view of the delivery system of fig. 24.

Fig. 26 is a cross-sectional view illustrating some aspects of the delivery system of fig. 24-25.

Fig. 27 is a cross-sectional view illustrating some aspects of the delivery system of fig. 24-26.

Fig. 28 is a cross-sectional view illustrating some aspects of the delivery system of fig. 24-27.

Fig. 29 is a cross-sectional view of a portion of the viscoelastic delivery system of fig. 24-28, but with an alternative design of a strain relief element in accordance with an embodiment of the invention.

Fig. 30 is a cross-sectional view of a portion of the viscoelastic delivery system of fig. 24-28, but with an alternative design of the impeller according to an embodiment of the invention.

Fig. 31 is a cross-sectional view of a portion of the viscoelastic delivery system of fig. 24-28, but with yet another alternative design of the impeller.

Fig. 32 is a partial cross-sectional view showing some aspects of a viscoelastic delivery system in accordance with an alternative embodiment of the invention.

Fig. 33 is a perspective view of some components of the viscoelastic delivery system of fig. 32.

Fig. 34 is a perspective view of the exterior of the viscoelastic delivery system of fig. 32-33.

Fig. 35 is a partial cross-sectional view of an alternative adhesive control element shape for use with the viscoelastic delivery system of fig. 32-34.

Fig. 36 is a perspective view showing a toggle lock for use with the viscoelastic delivery system of the present invention.

Fig. 37 is a perspective view showing an alternative toggle lock for use with the viscoelastic delivery system of the present invention.

Fig. 38 is a perspective view showing a beveled distal tip of a cannula extending from a viscoelastic delivery system in accordance with an embodiment of the present invention.

Fig. 39 is an elevation view of a beveled distal tip of the cannula of fig. 38.

Fig. 40 is a perspective view illustrating a cannula rotation feature of the viscoelastic delivery system.

Fig. 41 is a perspective view of some aspects of the cannula rotation feature of fig. 40.

Fig. 42 is a perspective view of some aspects of the cannula rotation feature of fig. 40.

Fig. 43 is a perspective view of a component of the cannula rotation feature of fig. 40.

Fig. 44 is a perspective view of another component of the cannula rotation feature of fig. 40.

Fig. 45 is a flow chart describing a method of treating an eye of a patient.

While the disclosure is amenable to various modifications and alternative forms, specifics thereof have been shown by way of example in the drawings and will be described in detail. It should be understood, however, that the intention is not to limit the invention to the particular embodiments described. On the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the disclosure.

Detailed Description

The following description should be read with reference to the drawings, which are not necessarily drawn to scale, wherein like reference numerals indicate like elements throughout the several views. The detailed description and drawings are intended to illustrate rather than limit the claimed invention. Those of skill in the art will recognize that the various elements described and/or illustrated may be arranged in various combinations and configurations without departing from the scope of the disclosure. The detailed description and drawings illustrate example embodiments of the claimed invention.

Definitions of certain terms are provided below and these definitions shall apply unless a different definition is given in the claims or elsewhere in this specification.

It is assumed herein that all numerical values are modified by the term "about," whether or not explicitly indicated. The term "about" generally refers to a range of values that one of ordinary skill in the art would consider equivalent to (i.e., having the same or substantially the same function or result as) the stated value. In many instances, the term "about" may include numerical values rounded to the nearest significant figure. Other uses of the term "about" (i.e., in a context other than numerical values) may be assumed to have their ordinary and customary definition(s) understood from and consistent with the context of the specification, unless otherwise indicated.

The recitation of numerical ranges by endpoints includes all numbers subsumed within that range (e.g. 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5).

As used in this specification and the appended claims, the singular forms "a," "an," and "the" include or otherwise refer to the singular and the plural, unless the content clearly dictates otherwise. As used in this specification and the appended claims, the term "or" is generally employed in its sense including "and/or" unless the content clearly dictates otherwise.

It should be noted that references in the specification to "an embodiment," "some embodiments," "other embodiments," etc., indicate that the embodiment(s) described may include a particular feature, structure, or characteristic, but every embodiment may not necessarily include the particular feature, structure, or characteristic. Moreover, such phrases are not necessarily referring to the same embodiment. Further, when a particular feature, structure, or characteristic is described in connection with an embodiment, it is submitted that it is within the knowledge of one skilled in the art to effect such feature, structure, or characteristic in connection with other embodiments whether or not explicitly described unless explicitly stated to the contrary. That is, the various individual elements described below, even if not explicitly shown in a particular combination, are contemplated as being combinable or capable of being arranged with each other to form other additional embodiments or to supplement and/or enrich the described embodiment(s), as will be appreciated by one of ordinary skill in the art.

The following detailed description should be read with reference to the drawings, in which like elements in different drawings are identified with the same reference numerals. The drawings, which are not necessarily to scale, depict illustrative embodiments and are not intended to limit the scope of the disclosure.

Fig. 1 is a stylized perspective view depicting a portion of a human eye 20. Eye 20 may be conceptualized as a fluid-filled ball having two eye chambers. The sclera 22 of the eye 20 surrounds a posterior chamber 24 filled with a viscous fluid known as vitreous humor. Cornea 26 of eye 20 encloses an anterior chamber 30 filled with a fluid known as aqueous humor. Cornea 26 meets sclera 22 at limbus 28 of eye 20. The lens 32 of the eye 20 is positioned between the anterior chamber 30 and the posterior chamber 24. The lens 32 is held in place by a plurality of zonules 34. Each time a person views an object, he or she views the object through the cornea, aqueous humor, and lens of the eye. For transparency, the cornea and lens may not include blood vessels. Thus, no blood flows through the cornea and lens to provide nutrition to these tissues and remove waste products from these tissues. Alternatively, these functions are performed by aqueous humor. The continuous flow of aqueous humor through the eye provides nutrition to the non-vascular portions of the eye (e.g., the cornea and lens). This flow of aqueous humor also removes waste from these tissues.

Aqueous humor is produced by an organ called the ciliary body. The ciliary body includes epithelial cells that continuously secrete aqueous humor. In a healthy eye, aqueous humor flows out of the eye as new aqueous humor is secreted by the epithelial cells of the ciliary body. This excess aqueous fluid enters the blood stream and is carried away by venous blood leaving the eye.

In a healthy eye, aqueous humor flows out of anterior chamber 30 through trabecular meshwork 36 and into schlemm's canal 38 at the outer edge of iris 42. Aqueous humor exits schlemm 38 by flowing through a plurality of outlets 40. After exiting schlemm 38, the aqueous humor is absorbed into the venous blood flow.

FIG. 2 is a stylized representation of a medical procedure according to this embodiment. In the procedure of fig. 2, a doctor is treating the eye 400 of patient P. In the procedure of fig. 2, the physician is holding the handpiece of the viscoelastic delivery system 450 in his or her right hand RH. The left hand of the physician (not shown) may be used to hold the handle H of the gonioscopic lens 402. Alternatively, some doctors may prefer to hold the delivery system handpiece with the left hand and the gonioscopic handle H with the right hand RH.

During the procedure illustrated in fig. 2, a physician may view the interior of the anterior chamber using an gonioscope 402 and a microscope 404. Detail a of fig. 2 is a stylized simulation of an image viewed by a physician. The distal portion of cannula 452 is visible in detail a. The shaded lines indicate the location of schlemm SC, which is located under various tissues surrounding the anterior chamber (e.g., trabecular meshwork). Distal opening 454 of cannula 452 is positioned adjacent schlemm's canal SC of eye 400.

The method according to this embodiment may comprise the steps of: the distal end of the cannula 452 is advanced through the cornea of the eye 400 such that the distal portion of the cannula 452 is disposed in the anterior chamber of the eye. The cannula 452 may then be used to access schlemm's canal of the eye, for example, by puncturing the wall of schlemm with the distal end of the cannula 452. The distal opening 454 of the cannula 452 may be placed in fluid communication with a lumen defined by schlemm's canal. Viscoelastic materials may be administered from a cannula into schlemm's canal to open the aqueous outflow path. Delivery of viscoelastic materials into schlemm's canal may promote aqueous humor flow out of the anterior chamber of the eye.

Fig. 3 is an enlarged perspective view further showing the viscoelastic delivery system 450 and eye 400 shown in the previous figure. In fig. 3, a cannula 452 extending from a handle 453 of the viscoelastic delivery system 450 is shown extending through the cornea 426 of the eye 400. The distal portion of the cannula 452 is disposed inside the anterior chamber defined by the cornea 426 of the eye 400. In the embodiment of fig. 3, the cannula 452 is configured such that the distal opening 454 of the cannula 452 may be placed in communication with the scleral vein Dou Liuti.

In the embodiment of fig. 3, the viscoelastic material may be administered into schlemm's canal through a cannula. In some embodiments, the catheter or microcatheter may be disposed within a cannula of the viscoelastic delivery system. The catheter may be configured to be advanced out of the cannula into schlemm's canal. In this embodiment, the viscoelastic material may be delivered from a catheter into schlemm's canal. The delivery system 450 includes a mechanism that is capable of advancing and retracting the catheter along the length of the cannula 452. When the distal opening of the cannula 452 is in communication with the scleral vein Dou Liuti of the eye 400, the viscoelastic material can be delivered into the schlemm's canal by advancing the catheter through the distal opening. The viscoelastic material may then be administered from the catheter into schlemm's canal.

The viscoelastic material may be delivered into schlemm's canal of the eye either before or after the ocular implant is delivered into the patient's eye. In one embodiment, the delivery system may be connected to an adhesive module 460 remote from the body or handle 453 of the delivery system 450. The adhesive module 460 may be configured to deliver the viscoelastic material through a lumen or tubing into a catheter within a cannula of a delivery system. In one implementation, the delivery system may include a viscous trigger 462 on the handle 453 configured to release the viscoelastic material from the viscous module 460 into a catheter of the delivery system.

The delivery system 450 may further include a catheter advancement wheel 464 configured to advance or retract the catheter within the cannula and within schlemm's canal. For example, advancing the catheter advancement wheel 464 in a distal direction (e.g., toward the cannula) may advance the catheter toward the distal tip of the cannula and partially out of the cannula into schlemm's canal when the distal end of the cannula is in communication with the scleral vein Dou Liuti of the patient's eye. Further, moving the catheter advancement delivery wheel in a proximal direction (e.g., toward the viscous trigger 462) may move the catheter proximally within the cannula and withdraw the catheter within and from the schlemm's canal. The separate catheter pusher wheel 464 allows the catheter to move within schlemm's canal without any viscoelastic material being administered from the catheter. Similarly, the adhesive trigger 462 on the handle allows the viscoelastic material to be administered from the catheter into schlemm's canal without moving the catheter.

Fig. 4 is an illustration of the distal end of the cannula 452 of the viscoelastic delivery system of fig. 3. In fig. 4, a conduit 453 is shown to extend partially from a distal opening 454 of cannula 452. As described above, the catheter 453 can be slidably disposed within the cannula and can be partially advanced (e.g., using catheter advancement wheel 464) beyond the distal opening of the cannula. The conduit 453 can be formed of, for example Polyamide,/->Elastomer, nylon or any other suitable material. In one embodiment, the catheter may have dimensions (e.g., 0.008 inch outer diameter by 0.006 inch inner diameter) and cross-sectional shapes (e.g., circular cross-section, oval cross-section, etc.) that match the dimensions and cross-sectional shapes of the interior of the cannula. It should be appreciated that the conduit 453 can be any shape so long as the conduit is slidably disposed within the cannula. The catheter 453 can have a length of 16-18mm so that the catheter can extend beyond the distal tip of the cannula somewhat surrounding schlemm's canal. The catheter 453 may include a distal opening 455 that may be configured to deliver a viscoelastic material into a body structure such as schlemm's canal. It should be appreciated that the conduit 453 includes a lumen in fluid communication with a source of viscoelastic material (e.g., the viscous module 460) to facilitate application of the viscoelastic material. Although the illustrative embodiment includes only distal opening 455, in other embodiments the catheter may include additional openings, such as openings along the side of the catheter.

Fig. 5 is an illustration of a viscoelastic delivery system 500 that includes a delivery system 550 and a viscous module 560 external to the delivery system 500. The delivery system 550 has a handle 552 and a cannula 554 extending from a distal end of the handle 552. The cannula 554 has an internal passage and a distal opening configured to be placed in communication with the scleral vein Dou Liuti. A catheter (not shown) is movably disposed within cannula 554 such that the catheter may be pushed out of the cannula into schlemm's canal and retracted back into the cannula.

The viscous module 560 can be adapted to receive or house various viscous syringes 566. The viscous injector 566 may be connected to the tubing 568 (via, for example, a female luer connector) using sterile technology to fluidly couple the viscoelastic material in the internal cavity of the viscous injector to the catheter within the delivery system 550. In one embodiment, the viscous module 560 can be configured to automatically pressurize the interior cavity of the viscous injector 566 when the injector is inserted into the module. Toggling the adhesive trigger 562 on the handle 552 of the delivery system 550 may allow a pressurized flow of viscoelastic material from the adhesive syringe and adhesive module into the delivery system 550, and out one or more ports of a catheter of the delivery system and into schlemm's canal. As described above, the delivery system may also include a catheter advancement wheel 564 configured to advance and retract a catheter within the cannula of the delivery system, thereby advancing and retracting the catheter within schlemm's canal. The separate catheter pusher wheel 564 allows the catheter to move within schlemm's canal without any viscoelastic material being administered from the catheter. Similarly, an adhesive trigger 562 on the handle enables the viscoelastic material to be administered from the catheter into schlemm's canal without moving the catheter.

Fig. 6-7 show cross-sectional views of adhesive module 660 in an open, unpressurized configuration and in a closed, pressurized configuration, respectively. In this embodiment, the viscous injector 666 may rest within a cradle 670, which may be configured to accommodate a wide variety of viscous injector sizes and shapes. A spring assembly 674 (e.g., a compression spring or a constant force spring) may be placed in contact with a 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 bring the spring assembly into contact with the plunger 672. Rotation of the outer regulator tube 676 may adjust the relative position of the outer regulator tube 676 with respect to the inner regulator tube 678. For example, the outer regulator sleeve may be complementarily threaded with the inner regulator sleeve 678 to facilitate relative positional adjustment of the outer regulator sleeve against the plunger 672.

The adhesive module 660 of fig. 6-7 further includes a piston 680 coupled to one end of the arm 682 and a module cap 684 coupled to the other end of the arm. In some embodiments, these components may be rotationally coupled together with a pivot or hinge. When the adhesive module is in the open configuration of fig. 6, the module cover 684 pulls the arm 682 and the piston 680 away from the spring assembly 674. However, in the closed configuration of fig. 7, the closing module cover 684 moves the arm and piston into the spring assembly to partially compress the spring. The spring assembly may then begin to apply a constant force to the plunger 672 of the syringe 666, effectively pressurizing the syringe. The operator may then control the delivery of the viscoelastic material from the reservoir of the syringe 666 into the delivery system, for example, by deploying a viscous trigger (such as viscous trigger 562 in fig. 5) on the delivery system connected to the viscous module.

Fig. 8-9 are additional views of the adhesive module of fig. 6-7, showing loading of adhesive injector 666 into adhesive module 660. Also shown in fig. 8-9 are an outer adjuster barrel 676 and an inner adjuster barrel 678, illustrating how fine adjustment can be made to position the spring assembly against the plunger of the syringe.

Fig. 10-12 illustrate another embodiment of a viscoelastic delivery system 700 that includes a delivery system 750 and an adhesive module 760. The delivery system 750 has a handle 752 and a cannula 754 extending from a distal end of the handle 752. The cannula 754 has an internal passage and a distal opening configured to be placed in communication with the scleral vein Dou Liuti. A catheter (not shown) is movably disposed within cannula 754 such that the catheter may be advanced out of the cannula into schlemm's canal and retracted back into the cannula. The conduit has one or more outlet ports. A toggle-type adhesive trigger 762 on the delivery system 750 may allow a pressurized flow of viscoelastic material from the adhesive module 760 through the tubing 768 into a catheter within the cannula 754 and out of the outlet port(s) of the catheter.

The adhesive module 760 is adapted to receive viscoelastic material from an adhesive syringe prior to use of the system to treat a patient. As shown in fig. 11-12, the outlet of the viscous syringe may be connected with a luer fitting 786 at an inlet 785 of the viscous module 760. The viscous injector may inject a viscoelastic material through inlet 785 and one-way valve 787 into passage 789 leading to the luer connector. Tubing 768 connected to connector 793 extends to the delivery system. During injection of the viscoelastic material from the viscous injector, the system may be primed by opening the viscous trigger 762 until the viscoelastic material passes from the inlet 785, the passage 789, the tubing 768, and out of the outlet port(s) of the catheter, as shown in fig. 11. Releasing the viscous trigger stops the flow of the viscoelastic material through the catheter. Thereafter, as the viscoelastic material continues to be injected from the viscous injector, the fluid pressure causes the piston rod 788 to move away from the inlet 785 against the operation of the spring 792 (which is connected to the piston rod 788 via the plate 790), and the pressurized viscoelastic material fills the cavity 766, as shown in fig. 12. When filling is complete, the viscous syringe is removed and the one-way valve 787 prevents back flow of the viscoelastic material through the inlet 785. The O-ring seal 791 prevents the viscoelastic material from leaking around the piston rod 788. When the adhesive trigger 762 of the delivery system 750 is again toggled open, the spring 792 moves the piston rod 788 back toward the inlet 785. Because the one-way valve 787 prevents viscoelastic material from passing through the inlet 785, this movement of the piston rod 788 ejects viscoelastic material from the lumen 766 into the channel 789, tube 768, and into the conduit within the cannula 754. After all of the viscoelastic material has been delivered from the cavity 766 through the tube 768, the viscous module returns to the configuration of fig. 11.

The catheter advancement wheel 764 is configured to advance and retract the catheter within the cannula 754 of the delivery system. The separate catheter advancement wheel 764 allows the catheter to be moved within schlemm's canal without any viscoelastic material being administered from the catheter. Similarly, the adhesive trigger 762 on the handle enables the viscoelastic material to be administered from the catheter into schlemm's canal without moving the catheter.

Fig. 13 illustrates an embodiment of an adhesive module 760 that adds graduation marks 794 to a partially transparent or translucent adhesive module body to form a viscoelastic cavity gauge. A portion 795 of the body may be opaque to conceal the spring 792. Fig. 14 shows an embodiment of an adhesive module 760 that adds an integral clip 796 to attach the adhesive module to an IV pole 995 (shown in fig. 23), a user's wrist (shown in fig. 22), or a user's clothing. In other embodiments, clip 796 may be omitted and tubing ties module 760 to the handle of delivery system 750 as module 760 and tubing 768 hang over the wrist of the user. In embodiments, tube 768 may be 3-4 inches long to achieve this overhang feature. In various embodiments, tube 768 may be formed from a high pressure braided reinforcing tube.

Fig. 15-18 illustrate an alternative embodiment of a sticky module 860. Similar to the embodiments described above, the viscous module can implement a spring (e.g., a compression spring) to provide compression against the plunger to pressurize the viscoelastic material flow within the viscous module. In this embodiment, the adhesive module may include a luer fitting 886 and a one-way check valve 887, as in the embodiment of fig. 10-12. A passage 889 extends through the stem 802 to the adhesive reservoir 894. Rod 802 extends from compression knob 896, threaded member 804 connected to compression knob 896, compression spring 892, and piston 889. The outlet 895 of the adhesive reservoir 894 is adapted to be connected via a connector 893 to a tubing (not shown) leading to a delivery system (not shown), such as the delivery system 750 described above. The reservoir 894 may be filled with a viscoelastic material, such as by connecting a viscous syringe to the luer fitting 886, with the viscous module in the configuration shown in fig. 16. If the viscous delivery system is connected to the outlet of the reservoir 894 via a tubing, and if the viscous delivery trigger of the viscous delivery system is pushed to an open position, the viscoelastic material will first fill the reservoir 894 and will then flow into the tubing and through the delivery system to the catheter outlet port of the delivery system to prime the system. After the adhesive delivery trigger of the delivery system is toggled to the closed position, the viscoelastic material in adhesive reservoir 894 of adhesive module 860 may be pressurized by rotating compression knob 896 such that threaded member 804 is advanced into housing 806 (the housing having corresponding threads). With the adhesive delivery trigger in the closed position, viscoelastic material does not flow from reservoir 894 and piston 889 remains in its retracted position as threaded member 804 advances. Flange 808 on the end of threaded member 804 compresses spring 892 against piston 889 during advancement of the threaded member to pressurize reservoir 894, as shown in fig. 17. The operator may then control the delivery of the viscoelastic material from the viscous module 860 into the delivery system, for example, by deploying a viscous trigger (such as viscous trigger 762 in fig. 10) on the delivery system connected to the viscous module. As viscoelastic material is delivered from reservoir 894, spring 892 moves piston 889 toward outlet 895 until the reservoir is depleted, as shown in fig. 18. In some embodiments, the reservoir portion of the housing 806, or the entirety of the housing 806, may be transparent or translucent so that the amount of viscoelastic material contained by the housing can be seen. Indicia may be added to the housing to help quantify the amount of viscoelastic material delivered and/or the amount left in the housing.

Fig. 19 shows a modification of the embodiment of fig. 15 to 18. In this embodiment, the viscous inlet luer 886 'and one-way check valve 887' are on the side of the housing 806 'of the viscous module 860'. Rod 802 'extends between a threaded member 804' connected to compression knob 896 'and piston 889'. Compression spring 892' also extends between threaded member 804' and piston 889'. The outlet 895' of the adhesive reservoir 894' is adapted to be connected via a connector 893' to a tubing (not shown) leading to a delivery system (not shown), such as the delivery system 750 described above. The reservoir 894 'may be filled with a viscoelastic material, such as by connecting a viscous syringe to the luer fitting 886', with the viscous module in the configuration shown in fig. 19. If the viscous delivery system is connected to the outlet of reservoir 894 'via tubing, and if the viscous delivery trigger of the viscous delivery system is pushed to the open position, the viscoelastic material will first fill reservoir 894' and will then flow into the tubing and through the delivery system to the catheter outlet port of the delivery system to prime the system. After the viscous delivery trigger of the delivery system is toggled to the closed position, the viscoelastic material in the viscous reservoir 894' of the viscous module 860' may be pressurized by rotating the compression knob 896' such that the threaded member 804' is advanced into the housing 806' (the housing having corresponding threads). With the adhesive delivery trigger in the closed position, the viscoelastic material does not flow from the reservoir 894' and the piston 889' remains in its retracted position as the threaded member 804' advances. Flanges on the ends of the threaded member 804 'compress the spring 892' against the piston 889 'during advancement of the threaded member to pressurize the reservoir 894'. The operator may then control the delivery of the viscoelastic material from the viscous module 860' into the delivery system, for example, by deploying a viscous trigger (such as viscous trigger 762 in fig. 10) on the delivery system connected to the viscous module. As viscoelastic material is delivered from reservoir 894', spring 892' moves piston 889 'toward outlet 895' until the reservoir is depleted. In some embodiments, the reservoir portion of the housing 806', or the entirety of the housing 806', may be transparent or translucent so that the amount of viscoelastic material contained by the housing can be seen. Indicia may be added to the housing to help quantify the amount of viscoelastic material delivered and/or the amount left in the housing.

Fig. 20-21 illustrate yet another embodiment of an adhesive module 1200 for use with a viscoelastic delivery system such as described herein. In this embodiment, the viscous inlet luer 1202 and one-way check valve 1204 open into an inlet 1206 on the top front side of a housing 1208 of the viscous module 1200. The inlet 1206 extends from the check valve 1204 to a top end of a tapered reservoir portion 1212 that is disposed at an end of a cylindrical reservoir portion 1214 of the reservoir 1210. Rod 1216 extends from piston 1222 to an interior passage 1218 of a hollow rod 1219 extending from compression knob 1220. A 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 adhesive reservoir 1210 is adapted to be connected via a connector 1226 to a tubing (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 leakage of viscoelastic material around the piston.

The reservoir 1210 may be filled with a viscoelastic material (such as by connecting a viscous syringe to the luer 1202) such that the piston 1222 within the reservoir 1210 moves away from the inlet 1204 to the position shown in fig. 20 where the piston 1222 engages the front edge of the stopper tube 1221, but the spring 1224 of the viscous module is in an uncompressed configuration (not shown) and the compression knob 1220 is rotated away from the housing 1208 (also not shown) to allow the piston to move away from the inlet 1204 during injection of viscoelastic material from the syringe. If the viscous delivery system is connected to the outlet of the reservoir 1210 via tubing, and if the viscous delivery trigger of the viscous delivery system is pushed to the open position, the viscoelastic material will first flow into the reservoir cone 1212, then into the tubing connected to the connector 1226 and through the delivery system to the catheter outlet port of the delivery system to prime the system. Then, as the piston is pushed back, additional viscoelastic material will fill the remaining reservoir. When the piston is at the end of the cylindrical portion 1214 (as shown in fig. 21), the position of the inlet 1206 directly below the cylindrical portion 1214 of the reservoir will cause the viscoelastic material to flow past the bottom surface 1223 of the piston 1222 at the beginning of the priming process, thereby purging any air bubbles that may form and deposit on the piston surface 1223 or in the reservoir cone portion 1212.

After toggling the viscous delivery trigger of the delivery system to the closed position, the viscoelastic material in the viscous reservoir 1210 of the viscous module 1200 can be pressurized by turning the compression knob 1220 such that the hollow rod 1219 is advanced over the rod 1216 into the housing 1208 (the housing having corresponding threads). With the adhesive delivery trigger in the closed position, the viscoelastic material does not flow from the reservoir 1210 and as the rod 1219 advances, the piston 1222 is held in its retracted position, compressing the spring 1224 and pressurizing the reservoir 1210, as shown in fig. 20. The operator may then control the delivery of the viscoelastic material from the viscous module 1200 into the delivery system, for example, by deploying a viscous trigger (such as viscous trigger 762 in fig. 10) on the delivery system connected to the viscous module. As viscoelastic material is delivered from reservoir 1200, spring 1224 moves piston 1222 toward outlet 1225 until the piston reaches the end of its range of motion, as shown in fig. 21. In some embodiments, the reservoir portion of the housing 1208, or the entirety of the housing 1208, may be transparent or translucent such that the amount of viscoelastic material contained by the housing can be seen. Indicia may be added to the housing to help quantify the amount of viscoelastic material delivered and/or the amount left in the housing.

Fig. 24-28 illustrate various views of the viscoelastic delivery system 1050 as discussed herein. As described above, the delivery system may include an adhesive trigger 1062 and a catheter advancement wheel 1064 supported by the handle 1052. Cannula 1054 extends from the distal end of handle 1052. Cannula 1054 has an interior passage and a distal opening configured to be placed in communication with scleral vein Dou Liuti. Referring to fig. 25, the catheter advance wheel 1064 may include a plurality of notches 1098. The wheel can be coupled to a rack and pinion mechanism 1099 that is coupled to a conduit 1053 (the conduit is formed, for example, byML21 nylon extrudate) to control advancement of the catheter 1053 within the cannula 1054.

In some embodiments, the gearing of the rack and pinion system may be optimized to advance the catheter a set distance for each notch 1098 of the catheter advance wheel 1064. For example, in one embodiment, the notches may be 3mm apart, and a 1:1 transmission may be used in the rack and pinion system, such that advancing the catheter advancement wheel one notch will advance the catheter 3mm. In alternative embodiments, other gear ratios may be used. For example, a 2:1 gear ratio may be used to advance the catheter 6mm with a 3mm spacing between the notches.

As shown in fig. 26-27, a cantilever spring 1065 formed of wire or formed as a molded plastic rod may slide along the ridge of the notched catheter pusher wheel 1064 to provide tactile feedback to the user to know exactly how far the catheter is advanced into schlemm's canal as the wheel rotates, thereby providing the user with knowledge of where the viscoelastic material is injected relative to the cannula tip. Fig. 30 shows an alternative catheter pusher wheel 1064' and an alternative cantilever spring 1065' that slides into and out of a recess 1067 in the side of the wheel 1064' to provide tactile feedback. Fig. 31 shows yet another alternative pusher wheel 1064 "having a recess 1067" and cantilever spring 1065 "for tactile feedback of catheter advancement.

In some embodiments, the rack and pinion mechanism 1099 is configured to travel 24mm. In the fully retracted configuration, the 24mm catheter 1053 is located within the handle 1052 and the catheter is located within a straight portion of the cannula 1054 near the distal curved portion of the cannula. During transport and/or storage, the catheter may remain in such a configuration that the catheter does not assume a bent setting from the bent portion of the cannula. Movement of the rack to 24mm of the maximum extended configuration will extend a 20mm catheter from the cannula.

Referring to fig. 25-28, the operation of the viscous trigger 1062 will now be discussed. As described above, the adhesive trigger 1062 may comprise a simple toggle lever that may alternate between an off state and an on state. When the adhesive trigger is in the off state, the delivery system 1050 does not deliver a flow of viscoelastic material through the catheter within the cannula. Conversely, when the adhesive trigger is moved to an on state, a flow of viscoelastic material is allowed to flow from the adhesive module (as described above) through the toggle valve 1001 and into the catheter/cannula of the delivery system. Thus, the amount of viscoelastic material delivered from the delivery system is related to the length of time that the adhesive trigger is in the on state.

Referring to fig. 26-28, the shaft 1003 is disposed at a position offset from the rotational axis 1063 of the adhesive trigger 1062, and the distal end of the shaft 1003 is disposed within a recess 1061 in the adhesive trigger 1062. As the trigger 1062 moves, the distal end 1004 of the shaft 1003 slides within the recess 1061. The distal end 1004 of the shaft 1003 may be convex (as shown in fig. 28), or may be flat. The offset position of the shaft 1003 relative to the rotational axis of the trigger 1062 causes the shaft 1003 to move forward and rearward along its longitudinal axis, which moves the compression spring 1005 forward and rearward and moves the position of the one or more o-rings 1007 within the toggle valve 1001. Movement of the o-ring(s) 1007 opens the valve to allow pressurized flow of viscoelastic material from the viscous module (as described above) through tubing 1010 into valve inlet 1009 and out of the valve outlet (not shown) into tubing 1012 leading to conduit 1053. (FIG. 26 omits the tube 1010 and most of the tube 1012 for clarity, similarly FIG. 28 illustrates the valve outlet 1011, omits the tube 1012 for clarity.) when the user's actuation force is released from the adhesive trigger, the spring 1005 decompresses to move the shaft 1003 and o-ring 1007 back into place, returning the adhesive trigger 1062 to its off state, closing the valve, and effectively stopping the flow of pressurized viscoelastic material.

A tube 1012 extends from the valve outlet through the strain relief element 1002 on the side of the toggle valve 1001. When the rack and pinion are in their maximum retracted position, the tube 1012 forms a loop within the handle 1052 (as shown in fig. 27) and straightens during catheter advancement. Fig. 29 shows a strain relief element 1002' having an alternative shape.

Fig. 32-34 illustrate other alternative embodiments of some of the components of the viscoelastic delivery system of fig. 24-28. In one embodiment, the viscous trigger 1362 of the delivery system has a modified shape. As described above, the adhesive trigger 1362 may be a simple toggle lever that may alternate between an off state and an on state. When the adhesive trigger is in the off state, the delivery system 1050 does not deliver a flow of viscoelastic material through the catheter within the cannula. Conversely, when an actuation force is applied to the adhesive trigger, the adhesive trigger moves back to an open state (as shown in fig. 32-34) and allows a flow of viscoelastic material from the adhesive module (as described above) through the toggle valve 1301 and into the catheter/cannula of the delivery system. Specifically, rearward movement of the viscous trigger 1362 moves the shaft 1306 against the action of the spring 1304 to move the ball valve 1305 away from its seat on the O-ring 1303 (as shown in fig. 32, where the valve housing 1310 is shown in phantom lines) to allow pressurized viscoelastic material to flow into the valve housing 1310 and out into the tubing 1012 leading to a conduit (not shown) of the delivery system. When the actuation force is removed, the viscous trigger 1362 returns to the off state, and the spring 1304 decompresses to move the ball valve 1305 back into position against its valve seat on the O-ring 1303, thereby closing the valve and effectively stopping the flow of pressurized viscoelastic material. The components of the valve housing 1310 may be bonded together. An opening 1312 may be formed in the valve housing 1310 to facilitate glue injection.

The adhesive trigger may be a simple lever such as the lever 1062 in fig. 28 or the lever 1362 in fig. 32-34, or alternatively the adhesive trigger may have an angled shape such as the lever 1362' shown in fig. 35. The adhesive trigger 1062, adhesive trigger 1362, and adhesive trigger 1362' may be formed of plastic (e.g., PEEK), stainless steel, or any other suitable material.

Fig. 36 shows a toggle lock 1340 that holds the adhesive trigger 1362 in its rearward (open) position during pouring. Toggle lock 1340 can be removed from handle 1052 by pulling tab 1341 upward after priming and prior to pressurizing the adhesive cartridge (e.g., by turning compression knob 1220 of the embodiment of fig. 20) and using the viscoelastic delivery system to treat the patient. Fig. 37 shows an alternative toggle lock 1340 'with a larger tab 1341' to facilitate removal of the toggle lock from the handle 1052.

Fig. 38 and 39 show details of the distal end of cannula 1054 of the viscoelastic delivery system, with beveled tip 1055. The tip 1055 may be electropolished so that it does not sharpen to puncture or shear the catheter 1054 as the catheter 1053 (not shown in fig. 38) is moved in and out of the cannula, but is sharp enough to puncture trabecular meshwork tissue during treatment. As shown in fig. 39, tip 1055 has two planar surfaces 1056 and 1057 at the distal end, formed, for example, by grinding angled surface 1058.

Fig. 40-44 illustrate how a curved cannula 1054 extending from a handle 1052 may be rotated a known amount relative to the handle. Cannula 1054 is welded to rotatable hub 1402 extending from the distal end of handle 1052, with the angled tip of the cannula pointing toward one of two notches 1403 in hub 1402. The cylinder 1404 extends around the hub 1402. The canister 1404 has a groove 1408 at a proximal open end 1409 that abuts an O-ring 1410 on the handle. The locking plug 1412 is disposed with its proximally facing surface against the distally facing surface 1407 surrounding the distal opening 1406 of the cartridge 1404 to connect the cartridge 1404 to the hub 1402 such that the cartridge 1404, hub 1402, and cannula 1054 rotate together. Two legs 1414 extend proximally from the locking plug 1412 through the notch 1403. Protrusions 1416 on legs 1414 engage a proximally facing surface of hub 1402 to press the cartridge proximally against O-ring 1410, and ridges 1418 on legs 1414 engage corresponding grooves 1420 on the inside of cartridge 1404. Cannula 1054 extends through distal opening 1406 of barrel 1404 and through opening 1422 in locking plug 1412. When assembled, the lines 1424 on the exterior of the canister 1404 are aligned with the radial direction in which the angled ends of 1054 extend. By orienting line 1424 via the graduation "clock hour" markings and/or number 1426 on handle 1052, the user will know the orientation of the curved end of cannula 1054, even when the cannula itself cannot be readily seen, for example, when the cannula has been inserted into the patient's eye. The O-ring 1410 provides a friction force against the free movement of the canister 1404 to hold the canister/hub/cannula assembly in its rotated position. The cylinder 1404 may have grooves, ridges or knurls 1405 to facilitate gripping.

The systems described herein provide novel and unique viscoelastic delivery systems. The delivery system itself includes a separate trigger or mechanism for deploying or applying the viscoelastic material from the delivery system into the eye and for controlling the location of the deployment of the viscoelastic material (via the catheter). Methods of use may also be provided herein.

Referring to fig. 45, a flow chart describing a method of treating a patient's eye with an ocular system is provided. The method may comprise the steps of:

at operation 1102 of fig. 45, the method may include inserting a distal end of a cannula of an ocular system into an anterior chamber of an eye. In some embodiments, the cannula may be inserted through an incision in the eye into the anterior chamber. In other embodiments, the cannula may penetrate the eye with its distal end to access the anterior chamber.

At operation 1104, the method may further include placing the distal end of the cannula in communication with the scleral vein Dou Liuti such that the cannula enters the schlemm's canal in a substantially tangential orientation.

At operation 1106, the method may further include actuating a first control device of the ocular system to push the catheter out of the cannula and into schlemm's canal. The first control device may further advance and retract the catheter within schlemm's canal, and the first control device may fully retract the catheter into the cannula. As described above, the delivery system may include a viscoelastic pusher wheel configured to move the catheter of the delivery system within the cannula. The catheter may be moved distally, for example, from the cannula such that the catheter extends partially beyond the distal opening of the cannula. Alternatively, the catheter may be moved proximally relative to the distal end of the cannula. Adjusting the position of the catheter relative to the cannula may be used to adjust the position of the viscoelastic delivery port of the catheter. In one example, the viscoelastic delivery port includes an opening at the distal end of the catheter. The viscoelastic delivery port may be configured to apply a flow of viscoelastic material into a tissue or body structure. In some implementations, the first control device may be a control wheel, lever, switch, button, or the like disposed on a handle of the ocular system. In other embodiments, the first control device may be remote from the handle of the system (e.g., a foot switch). The first control means may include physical features such as detents, notches, etc. to provide tactile feedback to the user as to how far the catheter has been advanced or retracted.

At operation 1108, the method may further include actuating a second control device of the ocular system to administer the viscoelastic material into the catheter and into schlemm's canal. In some implementations, the second control device may be a control wheel, lever, switch, button, or the like disposed on a handle of the ocular system. The first control device and the second control device may be adjacent to each other or may be positioned on the handle to allow a user to manipulate the first control device and the second control device. In some embodiments, the second control device is remote from the handle (e.g., positioned on the viscoelastic module).

The second control means may comprise an on/off switch, wherein the viscoelastic material flows out of the conduit in the on position and does not flow out of the conduit in the off position. In other embodiments, the second control device may deposit a known volume of viscoelastic material into schlemm's canal. The second control device allows the user to control how much viscoelastic material is delivered to schlemm's canal. In some examples, a consistent mass or volume of viscoelastic material may be injected into schlemm's canal each time the position of the viscoelastic delivery port is adjusted. In some embodiments, a greater volume of viscoelastic material may be applied when desired. The position of the catheter, and thus the viscoelastic delivery port, may be controlled by the user independently of the application of the viscoelastic material (e.g., via the first and second control devices, respectively).

In some embodiments, the viscoelastic material may be applied prior to delivery of the ocular implant to open the aqueous outflow pathway. In other embodiments, the viscoelastic material may be administered after placement of the ocular implant within schlemm's canal.

It is to be understood that even though numerous characteristics of the various embodiments have been set forth in the foregoing description, together with details of the structure and function of the various embodiments, this detailed description is illustrative only, and changes may be made in detail, especially in matters of structure and arrangement of parts illustrated in the various embodiments to the full extent indicated by the broad general meaning of the terms in which the appended claims are expressed.

Claims (34)

1. A method of treating an eye of a patient with an ocular system, the method comprising:

inserting a distal end of a cannula of the ocular system into an anterior chamber of the eye;

placing the cannula in communication with the scleral vein Dou Liuti, a catheter disposed within the cannula;

actuating a first control device of the ocular system to advance the catheter from the cannula into schlemm's canal; and

a second control device of the ocular system is actuated to administer viscoelastic material from a viscoelastic delivery port of the catheter into schlemm's canal without moving the catheter.

2. The method of claim 1, the method further comprising: actuating the first control device to retract the catheter within schlemm's canal and advance the catheter into the cannula.

3. The method of claim 1, the method further comprising:

pressurizing a volume of viscoelastic material within a viscoelastic module, wherein the step of actuating the second control device comprises: a second control device of the ocular system is actuated to apply a viscoelastic material from the viscoelastic module into the catheter.

4. The method of claim 3, wherein the ocular system comprises a handle, the cannula, the first control device, and the second control device each extend from and are supported by the handle, the viscoelastic module being disposed external to the handle.

5. The method of claim 3, wherein pressurizing the volume of viscoelastic material comprises applying a spring to a plunger of a viscoelastic syringe disposed within the viscoelastic module.

6. The method of claim 3, wherein pressurizing the volume of viscoelastic material comprises pressurizing a reservoir within the viscoelastic module.

7. The method of claim 6, wherein pressurizing the reservoir comprises compressing a spring engaged with a wall of the reservoir.

8. The method of claim 7, wherein compressing a spring comprises operating an actuator extending from the viscoelastic module.

9. The method of claim 6, the method further comprising: the reservoir is filled with a viscoelastic material for a viscoelastic syringe.

10. The method of claim 9, the method further comprising: a viscoelastic material is advanced from the viscoelastic syringe into the catheter.

11. The method of claim 10, wherein the step of advancing a viscoelastic material from the viscoelastic injector into the catheter is performed prior to the step of filling the reservoir with viscoelastic material from the viscoelastic injector.

12. The method of claim 1, the method further comprising: providing a tactile feedback upon actuation of the first control device, the tactile feedback being related to the length of the catheter being moved into or out of the cannula.

13. The method of claim 1, the method further comprising: the ocular implant is advanced into schlemm's canal prior to the viscoelastic material being administered into schlemm's canal.

14. The method of claim 1, the method further comprising: the ocular implant is advanced into schlemm's canal after the viscoelastic material is applied into schlemm's canal.

15. An ocular viscoelastic delivery system, the ocular viscoelastic delivery system comprising:

a handle;

a cannula defining a passageway extending from the handle to a distal cannula opening, the cannula sized and configured to be advanced through an anterior chamber of an eye of a patient to place the distal cannula opening in communication with a scleral vein Dou Liuti of the eye;

a catheter slidably disposed within the cannula passageway, the catheter including a viscoelastic delivery port, at least a distal portion of the catheter being sized and configured to be advanced from the cannula into schlemm's canal;

a viscoelastic module in fluid communication with the catheter and the viscoelastic delivery port, the viscoelastic module configured to contain a pressurized volume of viscoelastic material external to the handle;

a first control device configured to adjust the position of the catheter and the viscoelastic delivery port relative to the cannula; and

A second control device configured to release pressurized viscoelastic material from the viscoelastic module into schlemm's canal through the catheter and viscoelastic delivery port.

16. The delivery system of claim 15, wherein the viscoelastic module further comprises:

a carrier configured to receive a viscoelastic syringe; and

a force assembly configured to contact a plunger of the viscoelastic syringe, the force assembly further configured to apply a constant force to the plunger.

17. The system of claim 16, wherein the force assembly further comprises an adjustment mechanism configured to adjust a position of the force assembly relative to the plunger.

18. The system of claim 15, wherein the viscoelastic module comprises a reservoir and a spring configured to pressurize viscoelastic material in the reservoir.

19. The system of claim 18, further comprising an actuator extending from the viscoelastic module and configured to compress the spring to pressurize the reservoir.

20. The system of claim 18, wherein the viscoelastic module further comprises an inlet port adapted to engage a viscoelastic syringe, the inlet port being a fluid capable of fluid communication with the reservoir.

21. The system of claim 20, further comprising a check valve disposed between the inlet port and the reservoir, the check valve 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 inlet port from the reservoir.

22. The system of claim 15, wherein the first control device and the second control device are disposed on the handle.

23. The system of claim 15, wherein a single actuation of the first control device moves the catheter a known distance.

24. The system of claim 15, further comprising a cantilever spring engaged with the first control device and adapted to provide tactile feedback of movement of the first control device.

25. The system of claim 15, wherein a single actuation of the second control device applies a known volume of viscoelastic material from the catheter and viscoelastic delivery port into schlemm's canal.

26. The system of claim 15, wherein the second control device comprises a tap lever operable to move to a first position to open a valve to deliver viscoelastic material from the viscoelastic module into the catheter, the second control device further comprising a spring operable to move the tap to a second position to close the valve.

27. The system of claim 26, further comprising a toggle lock configured to retain the toggle lever in the first position.

28. The system of claim 27, wherein the toggle lock is removably disposed on an outer surface of the handle and is engaged with the toggle lever.

29. The system of claim 15, further comprising a tube extending from the viscoelastic module to the handle, the tube comprising a fluid lumen extending from an outlet of the viscoelastic module to an inlet control device in the handle.

30. The system of claim 29, wherein the tube has a length of 3-4 inches.

31. An ocular delivery system, the ocular delivery system comprising:

A handle;

a hub disposed at a 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, the cannula defining a passageway extending from the handle to a distal cannula opening, the cannula sized and configured to be advanced through an anterior chamber of a patient's eye to place the distal cannula opening in communication with a scleral vein Dou Liuti of the eye, the cannula having a curved distal end;

a cannula orientation marker rotatable with the hub and visible from an exterior of the delivery system, the marker aligned with a radial direction in which a curved distal end of the cannula extends; and

a fixation mark supported by the handle, the cannula orientation mark and the fixation mark together indicating an orientation of the curved distal end of the cannula relative to an orientation of the handle.

32. The ocular delivery system of claim 31, further comprising a catheter slidably disposed within the cannula passageway, the catheter comprising a viscoelastic delivery port, at least a distal portion of the catheter sized and configured to be advanced from the cannula into schlemm's canal, and a reservoir adapted to deliver a viscoelastic material into the catheter.

33. The ocular delivery system of claim 32, further comprising a control device configured to adjust the position of the catheter and the viscoelastic delivery port relative to the cannula.

34. The ocular delivery system of claim 32, further comprising a control device configured to release pressurized viscoelastic material from the reservoir into schlemm's canal through the catheter and viscoelastic delivery port.