# Patent

## Title
Flow promoting ocular implant

## Abstract

Disclosed are devices, methods and systems for treatment of eye disease, including open angle glaucoma and narrow angle glaucoma. Implants are described herein that create a directed flow field, such as between the anterior chamber and either the supraciliary space or suprachoroidal space. In addition, the implant can include a variety of features, including extruded features, such as rings and pegs, which can assist in preventing ocular tissue from collapsing onto the implant and occluding fluid pathways.

## Background
REFERENCE TO PRIORITY DOCUMENT
This application claims the benefit of priority under 35 U.S.C. §119(e) of U.S. Provisional Patent Application Ser. No. 61/726,477 filed Nov. 14, 2012 under 37 C.F.R. §1.76(a). Priority of the filing date is hereby claimed and the full disclosure of the aforementioned application is incorporated herein by reference.


BACKGROUND
The mechanisms that cause glaucoma are not completely known, though glaucoma has been linked to abnormally high pressure in the eye, which can lead to optic nerve damage. Over time, the increased pressure can cause damage to the optic nerve, which can lead to blindness. Treatment strategies have focused on keeping the intraocular pressure down in order to preserve as much vision as possible over the remainder of the patient's life.
Pursuant to such strategies, one or more implants can be delivered into the eye for shunting fluid out of the anterior chamber in order to regulate pressure in the eye. Accurate placement of an implant in the angle of the eye can be critical for the targeted effect of reducing intraocular pressure (IOP). Placing an implant too distally into the eye, such as too distally into the supraciliary space, may leave no portion of the implant remaining in the anterior chamber. This can inhibit aqueous outflow, as the fluid will not have a direct communication with the flow target location if there is no opening to the anterior chamber.
Conversely if the implant is placed too proximally in the supraciliary space such that a significant portion of the implant remains in the anterior chamber, damage to the corneal endothelium may result from implants that protrude upwards and touch the cornea. Implants placed too proximally may also touch the iris resulting in increased amounts of pigment dispersion in the eye, which can increase outflow resistance and intraocular pressure by clogging the trabecular meshwork. Therefore, correct placement of the implant is desired for a safe and a successful surgical outcome.
Additionally, in at least some instances, reduction in IOP can be correlated with forming one or more areas of separation between parts of the eye, such as between the choroid and sclera. These areas of separation can at least assist in allowing fluid to flow from the anterior chamber of the eye to the suprachoroidal space or supraciliary space. However, although creating separation between parts of the eye may be beneficial, creating larger incisions in the eye is generally not. For instance, a larger diameter implant may be able to create greater separation between parts of the eye, such as between the sclera and choroid, but a larger incision would be necessary which can result in excess tissue damage to the eye.
SUMMARY
Disclosed herein are devices and methods related to implants for treating one or more physiological conditions of the eye. Some device embodiments disclosed herein include an ocular implant for implanting in an eye, which can include an elongate tubular body comprising a proximal end, a distal end and an inner lumen extending at least partway between the proximal end and the distal end. In addition, the ocular implant can include a fenestration extending from an outer surface of the tubular body and intersecting with the inner lumen, and an extruded feature extending from the outer surface of the tubular body and positioned adjacent the fenestration.
Some system embodiments disclosed herein include an implant delivery system including an implant configured for implantation into an eye where the implant can have an elongate tubular body including a proximal end, a distal end and an inner lumen extending at least partway between the proximal end and the distal end. In addition, the implant can include a fenestration extending from an outer surface of the tubular body and intersecting with the inner lumen, and an extruded feature extending from the outer surface of the tubular body and positioned adjacent the fenestration. Additionally, the delivery system can include a delivery device configured to insert the implant into the eye.
Some method embodiments disclosed herein include implanting an implant in an eye, with the method including securing an implant to a delivery device configured to insert the implant into the eye. In addition, the implant can include an elongate tubular body including a proximal end, a distal end and an inner lumen extending at least partway between the proximal end and the distal end. Additionally, the implant can include a fenestration extending from an outer surface of the tubular body and intersecting with the inner lumen, and an extruded feature extending from the outer surface of the tubular body and positioned adjacent the fenestration. The method can further include inserting the implant into the eye.
The details of one or more variations of the subject matter described herein are set forth in the accompanying drawings and the description below. Other features and advantages of the subject matter described herein will be apparent from the description and drawings, and from the claims.



BRIEF DESCRIPTION OF THE DRAWINGS
These and other aspects will now be described in detail with reference to the following drawings.
FIG. 1 shows an example cross-sectional view of a portion of the human eye.
FIG. 2 shows and an example cross-sectional perspective view of a portion of the eye showing a part of the anterior and posterior chambers of the eye and a schematic representation of an embodiment of an implant positioned inside the eye such that a proximal end is located in the anterior chamber and a distal end communicates with and/or is located in or near the supraciliary space.
FIG. 3A illustrates a side view of an embodiment of an ocular implant having a tubular body with an inner lumen and at least one fenestration.
FIG. 3B illustrates a cross-section view of the implant in FIG. 3A showing the fenestrations in fluid communication with the inner lumen.
FIG. 4A illustrates an embodiment of an implant having a variety of shaped and sized extruded features, including extruded rings and pegs.
FIG. 4B shows an enlarged section view of the implant in FIG. 4A showing the position of the pegs adjacent fenestrations for assisting in preventing occlusion of the fenestrations.
FIG. 5 illustrates an embodiment of an implant having an extruded feature configured as a large proximal ring.
FIG. 6A illustrates an embodiment of an implant having a plurality of micro-channels.
FIG. 6B shows an enlarged section view of the implant in FIG. 6A showing a proximal end of the implant which can have one or more fenestrations or micro-channels extending through a proximal outer wall of the implant.
FIG. 7A illustrates an embodiment of an implant having a beveled proximal end.
FIG. 7B shows an enlarged section view of the implant in FIG. 7A showing the beveled proximal end and a main inlet port.
FIG. 8A illustrates an embodiment of an implant having a wave-cut proximal end including at least one fenestration adjacent the proximal end of the implant.
FIG. 8B shows an enlarged section view of the implant in FIG. 7A showing the wave-cut proximal end with at least one fenestration adjacent the proximal end of the implant.
FIG. 9 illustrates an embodiment of an implant including stabilizing features and a receiving port for receiving one or more drugs.
FIG. 10 shows an embodiment of a delivery system, including a delivery device configured to deliver an ocular implant into an eye.
FIG. 11 shows an enlarged view of the delivery system of FIG. 10 showing the ocular implant mounted on a delivery component of the delivery device.
FIG. 12 shows an enlarged view of a section of an eye with an implant mounted on a guidewire approaching an implantation site from an anterior chamber of the eye.



Like reference symbols in the various drawings indicate like elements.
DETAILED DESCRIPTION
This disclosure describes methods and devices related to implanting an ocular implant into an eye for promoting fluid flow within the eye in order to treat a variety of diseases and ailments of the eye, including open angle glaucoma and narrow angle glaucoma. Some device embodiments described herein include ocular implants which are compact enough such that they do not require a large incision for implantation but can provide improved separation between one or more parts of the eye, such as between the sclera and choroid.
At least some embodiments of the ocular implant disclosed herein are configured to assist in promoting fluid flow from the anterior chamber of the eye to either the suprachoroidal space or the supraciliary space. In addition, the ocular implants can include a variety of features, including extruded features and fenestrations, which can assist in promoting fluid flow at least through the implant.
FIG. 1 is a cross-sectional view of a portion of the human eye. The eye is generally spherical and is covered on the outside by the sclera S. The retina lines the inside posterior half of the eye. The retina registers the light and sends signals to the brain via the optic nerve. The bulk of the eye is filled and supported by the vitreous body, a clear, jelly-like substance. The elastic lens L is located near the front of the eye. The lens L provides adjustment of focus and is suspended within a capsular bag from the ciliary body CB, which contains the muscles that change the focal length of the lens. A volume in front of the lens L is divided into two by the iris I, which controls the aperture of the lens and the amount of light striking the retina. The pupil is a hole in the center of the iris through which light passes. The volume between the iris and the lens is the posterior chamber PC. The volume between the iris and the cornea is the anterior chamber AC. Both chambers are filled with a clear liquid known as aqueous humor.
The ciliary body continuously forms aqueous humor in the posterior chamber by secretion from the blood vessels. The aqueous humor flows around the lens and iris into the anterior chamber and exits the eye through the trabecular meshwork, a sieve-like structure situated at the corner of the iris and the wall of the eye (the corner is known as the iridocorneal angle or the angle). Some of the aqueous humor can filter through the trabecular meshwork near the iris root into Schlemm's canal, a small channel that drains into the ocular veins. A smaller portion rejoins the venous circulation after passing through the ciliary body and eventually through the sclera (i.e., the uveoscleral route).
FIG. 2 is a cross-sectional, perspective view of a portion of the eye showing the anterior and posterior chambers of the eye. A schematic representation of an embodiment of an implant 10 is shown positioned inside the eye such that a proximal end 12 is located in the anterior chamber and a distal end 14 communicates with and/or is located in or near the supraciliary space. In another embodiment, the distal end 14 is located in the suprachoroidal space. It should be appreciated that FIG. 1 and other figures herein are schematic and are not necessarily to scale with respect to size and relative positions of actual eye tissue.
The ocular implants disclosed herein can provide a fluid pathway between at least the anterior chamber and either the supraciliary space or suprachoroidal space. For example, the implant can include a distal end that can be positioned in the supraciliary space or the suprachoroidal space. The implant may be positioned at least partially between the ciliary body and the sclera or it may be at least partially positioned between the sclera and the choroid. The distal end of the implant may be positioned between other anatomical parts of the eye.
In some embodiments, the implant can include an elongated tubular body having one or more internal lumens through which aqueous humor can flow, such as from the anterior chamber into either the suprachoroidal or supraciliary space. The implant can have a substantially uniform internal diameter along its entire length, although the shape of the implant can vary, such as along its length. Alternatively, the implant can have a variable internal diameter along its length. Moreover, the implant can have various cross-sectional shapes, such as a circular, oval or rectangular shape, and can vary in cross-sectional shape moving along its length. For example, the cross-sectional shape can be selected to facilitate easy insertion into the eye.
The internal lumen of the implant can serve as a passageway for the flow of aqueous humor through the implant directly from the anterior chamber toward or into the suprachoroidal space or supraciliary space. In addition, the internal lumen of the implant can be used as an access location to mount the implant onto a delivery system. The internal lumen can also be used as a pathway for flowing fluid, such as an irrigation fluid or a visco-elastic substance, into the eye for flushing or to maintain pressure in the anterior chamber, or using the fluid to assist in dissection, visualization or hydraulic creation of a dissection plane into or within the supraciliary or suprachoroidal space. Fluid can be flowed toward or into either the supraciliary or suprachoroidal space, for example via a delivery cannula or through the internal lumen of the shunt. The fluid can be flowed into the eye with a pressure sufficient to form a dissection plane into or within the supraciliary or suprachoroidal space. The fluid can accumulate within the eye so as to form a lake. In general, hydro-dissection or the injection of fluids such as visco-elastic substances can be used to separate the ciliary body from the sclera to enlarge an area of detachment of the ciliary body from the sclera with or without insertion of a device.
In at least some instances reduction in IOP can be correlated with the position of the implant which creates an area of separation between the choroid and sclera around at least a part of the implant (also known as “tenting”) and a space created around, for example, the most distal portion of the implant (also known as an “aqueous lake”). In addition, increasing the area of scleral and choroidal separation can improve IOP reduction in at least some instances.
Although increasing the area of scleral and choroidal separation can be advantageous, several drawbacks can occur if a lager implant, such as an implant larger than approximately 0.5-1.0 mm in diameter, is used to create the larger separation. For example, some drawbacks may include the requirement for a larger incision, such as along the limbus, due to a greater diameter implant. A larger incision may cause fluids to escape the eye, such as at least from the anterior chamber, and complicate the implantation procedure. For example, an incision less than 2.5 mm may be preferable for implantation of at least one implant.
Other drawbacks to using a larger diameter implant can include creating a larger cyclodialysis which may result in increased rates of hypotony post operatively and increased rates of retinal detachments. In addition, a larger implant can be more difficult to insert into the supraciliary and suprachoroidal space due to the requirement of greater tissue separation which may result in excess tissue damage. Therefore, an implant which is sized such that it does not require a large incision (such as less than 2.5 mm) and can promote the flow of aqueous fluid from the anterior chamber of the eye to the suprachoroidal space or supraciliary space may overcome the drawbacks discussed above while achieving an improved reduction in IOP.
The present disclosure includes various embodiments of ocular implants, such as implants which include a tubular structure having at least one inner lumen which extends through the length of the implant. For example, the proximal end can be configured to be positioned in the eye such that it allows aqueous fluid to flow into the inner lumen of the implant. The distal end of the implant can be configured and positioned in the eye such that it allows aqueous fluid to flow out of the implant. In addition, the proximal and distal end of the implant can include features that assist in promoting fluid flow through the implant and protect the eye from damage.
Additionally, either the proximal end or distal end of the implant can be radiused or chamfered in order to protect the eye from damage, such as from sharp edges. For example, at least one of the distal end and proximal end of the implant can be radiused or chamfered for promoting smooth insertion and interaction with surrounding tissue which can assist in minimizing cyclodialysis. Alternatively or in addition, either the proximal end or distal end of the implant can include features which assist in preserving or promoting fluid flow through the implant. For example, the proximal end or distal end can include a beveled or wave cut tip which can assist in preventing at least surrounding tissue from occluding the inner lumen and preventing fluid flow through the implant. Any number of a variety of proximal end or distal end shapes can be included in an implant implementation for assisting in preserving or promoting fluid flow through the implant.
Some implementations of the implant can include at least one fenestration. Any one fenestration can be placed anywhere along the implant, including at the proximal end, distal end, or along the length of the implant, for assisting in fluid flow through the implant. In addition, the fenestrations can have any number of a variety of sizes and shapes and can be arranged in any number of a variety of patterns along the implant. For example, the size of the fenestrations can increase distally which can assist in promoting fluid flow in the distal direction relative to the implant. Alternatively or in addition, the number of fenestrations can increase in the distal direction along the length of the implant, such that there are more fenestrations adjacent the distal end, which can also assist in promoting distal fluid flow.
Furthermore, one or more fenestrations can be in the shape of a channel which can extend along the length of the implant. More than one channel can extend along the distal end of the implant and form, for example, a bifurcated or trifurcated configuration. In addition, the channels can widen in the distal direction along the implant. Any of a variety of sized and shaped fenestrations positioned at one or more locations along the implant can assist in creating a pressure gradient which can promote distally directed flow in order to increase fluid flow through the implant in the distal direction and reduce IOP.
Some implementations of the implant can include one or more extruded features, such as for assisting fluid flow into one or more fenestrations. For example, one or more extruded pegs or rings can be positioned adjacent or near one or more fenestrations, including the main inlet and outlet port of the implant. The extruded features, such as the extruded pegs or rings, can assist in preventing surrounding tissue from blocking or occluding the fenestrations which can allow the implant to efficiently and effectively promote fluid flow through the implant and reduce IOP.
Alternatively or in addition, one or more features can be indented into the body of the implant for assisting with fluid flow through the implant. Any number of a variety of shaped and sized features, both indented and extruded, can be included in an implant for assisting with fluid flow through the implant, such as by preventing at least surrounding tissue from blocking or occluding one or more fenestrations.
In some embodiments, the implant can include a lumen which is partially or completely occluded with a bioabsorbable material. The bioasborbable material can be comprised of, for example, a polylactic acid (PLA), polylactic-co-glycolic acid (PLGA), any combination of these materials, or any other suitable degradable material. The bioabsorbable material can be configured to block the flow of fluid through the lumen during a post-operative period, such as, for example, the first week, first several weeks or first several months after implantation. The bioabsorbable material can assist in preventing tissue growth in the lumen of the implant during the post-operative period when foreign body reaction and inflammation may be highest. After a period of time, the bioabsorbable material may erode away and the lumen of the implant may become patent and allow fluid to flow through the lumen.
In some embodiments, the bioabsorbable material can be molded onto either end of the implant, such as like a cap. Alternatively, the bioabsorbable material may be filled through the entire lumen of the implant at a temperature above the melting temperature of the bioabsorbable material and then allowed to cool and form within the lumen. In addition, the bioabsorbable material may fill through any number of channels or cavities within the implant.
In addition, some extruded features, such as extruded pegs or rings, can assist in maintaining the implant in a desired location within the eye. For example, at least one extruded ring can be positioned along the length of the implant, such as at either the proximal or distal end of the implant, which can assist in retaining the implant in a desired location. By preventing migration of the implant after implantation in the eye, the implant can be prevented from causing damage to the eye and can work efficiently and effectively to reduce IOP.
Additionally, any one or more extruded feature can assist in providing tenting around one or more parts of the implant, including around at least one fenestration. The size, shape and positioning relative to one or more fenestrations (e.g., adjacent to one or more fenestrations) can affect the tenting effect and resulting fluid flow through the implant. Therefore, the extruded features can include any number of a variety of sizes, shapes and positions along the implant in order to achieve desired tenting effects and fluid flow through the implant.
Furthermore, some extruded features can be sized, shaped and positioned along the implant in order to assist in positioning the implant in the eye. For example, an extruded feature can include a larger diameter proximal extruded ring which can provide a hard stop during implantation. This can assist a user, such as a clinician, in determining the proper positioning of the implant and can assist in preventing over-insertion of the implant.
The implant can be made out of any number of medical grade materials, including at least one of stainless steel, polyimide, or other plastics and metal materials. Alternatively or in addition, the implant can be made out of any number of shape memory alloys, such as nitinol, or shape memory polymers. However, any number of medical grade materials may be used.
In addition, the implant can be coated with a drug, such as mitomycin or 5-FU which can be used, for example, in trabeculectomy surgeries in order to reduce fibrotic and inflammatory tissue response. One or more drugs can be adhered to the surface of the implant. Alternatively or in addition, the one or more drugs may be combined with a polymer comprising at least a part of the implant for a sustained release profile.
FIGS. 3A and 3B illustrate an embodiment of an ocular implant 20 having a tubular body with an inner lumen 21 which can extend through the length of the implant 20. In addition, the implant 20 can include at least one fenestration 23 along the length of the implant 20. The fenestrations 23 can provide a fluid passageway between one or more areas surrounding the implant 20 and the inner lumen 21 of the implant 20. Additionally, the fenestrations 23 can assist in promoting fluid flow through the implant 20, such as aqueous fluid, in order to reduce IOP.
For example, the fenestrations 23 can provide additional fluid passageways through the implant 20 other than though a main outlet port 25 at the distal end of the implant 20 or a main inlet port 26 at the proximal end of the implant 20. In addition, in the event either the main outlet port 25 or the main inlet port 26 of the implant 20 is occluded, the fenestrations 23 can provide alternate fluid passageways for fluid flowing through the implant 20, such as aqueous fluid flowing from the anterior chamber into the suprachoroidal space or supraciliary space.
Any number of fenestrations 23, which can vary in shape and size, can be positioned anywhere along the length of the implant 20. Additionally, the density of fenestrations 23 along the length of the implant 20 can vary. For example, more fenestrations 23 may be positioned near the distal end of the implant 20 than near the proximal end. As shown in FIGS. 3A and 3B, the number of fenestrations can increase distally along the implant 20. By increasing the number of fenestrations 23 along the implant 20 in the distal direction, distally directed fluid flow through the implant 20 can be promoted, such as by the formation of a pressure gradient. For example, this can be beneficial when the proximal end of the implant is positioned in the anterior chamber and the distal end is positioned in the suprachoroidal or supraciliary space for treatment of an eye having high IOP.
Additionally, as shown in FIGS. 3A and 3B, the fenestrations 23 can increase in size along the length of the implant 20. More specifically, the fenestrations 23 can increase in diameter as they are positioned closer to the distal end of the implant 20. Increasing the size of the fenestrations 23 in the distal direction along the length of the implant 20 can assist in creating a pressure gradient, which can promote distally directed flow. The implant 20 can have any number of a variety of sized and shaped fenestrations along the length of the implant 20 that can assist in promoting fluid flow through the implant 20, including promoting a distally directed fluid flow.
Therefore, by either increasing the number of fenestrations or the size of the fenestrations along a length of the implant in the distal direction, distally directed flow can be promoted through the implant 20 without having to increase either the inner diameter or outer diameter of the implant 20. This can allow the implant 20 to maintain a smaller diameter, which can be beneficial at least during implantation, while providing one or more fluid passageways that aggregately provide improved fluid flow between at least the proximal end and distal end of the implant.
In addition, FIGS. 3A and 3B illustrate an ocular implant 20 having one or more extruded features configured as rings 28 extending from the outer surface of the implant 20. The rings 28 can provide additional separation between the tissue surrounding the implant 20, such as the choroid and sclera. The rings 28 can assist in creating additional space, also known as tenting, which can promote fluid flow through the implant and reduce IOP without requiring the entire length of the implant 20 to increase in diameter. The tenting effect provided by the rings 28 can assist in preventing surrounding tissue from occluding the fenestrations 23. Occlusion of the fenestrations can reduce fluid flow through the implant 20 which can hinder the implant 20 from assisting with reducing IOP. For example, the one or more extruded features can improve fluid flow, such as by tenting, and minimize the potential for sclera or choroidal occlusion of the fenestrations 23 which can more effectively reduce IOP.
In some implementations, one or more rings 28 can be positioned at or near the distal end of the implant 20 for assisting in preventing occlusion of the more distally positioned fenestrations 23. In addition, one or more rings 28 can be positioned at or near the proximal end of the implant 20 for assisting in preventing occlusion and providing additional retention. Extruded features, such as rings 28, positioned along the implant 20, both proximally and distally, can provide additional retention of the implant 20 which can ensure against migration of the implant 20 after implantation. The size and shape of the rings 28 may vary and any number of rings 28 can extend along the length of an implant 20.
FIGS. 4A and 4B illustrate an embodiment of an implant 100 having a variety of shaped and sized extruded features. The implant 100 includes at least one ring 28 along the length of the implant, such as near the proximal end for at least providing retention of the implant 20 in the eye after implantation. In addition, the implant 100 includes at least one peg 32 along the length of the implant 20, such as near the distal end of the implant for at least assisting in efficient fluid flow through the implant 100 (i.e., by assisting in creating either a tenting effect or an aqueous lake). As with any extruded feature, the pegs 32 can vary in size and shape, including along the length of the implant 100.
FIG. 4A shows the pegs 32 increasing in diameter in the distal direction along the length of the implant 100. This configuration can assist in providing an increase in either tenting or aqueous lake effects, which can assist in promoting distally directed flow through the implant 100. The fenestrations 23 positioned along the implant 100 are also shown as distally increasing in diameter along the length of the implant which can also assist in promoting distally directed fluid flow through the implant 100, such as by creating a pressure gradient.
As shown in FIG. 4B, the extruded features, such as the pegs 32, can be positioned directly adjacent fenestrations 23 which can allow the extruded features to assist in preventing occlusion of the fenestrations 23 by pushing surrounding tissue away from the fenestrations 23. In addition, the extruded features, such as the pegs 32, can vary in height in order to provide a variety of tenting effects. Additionally, any number of a variety of features can be included to assist in creating a tenting effect, such as a sheath or cage which can expand around the fenestrations, without departing from the scope of this disclosure.
FIG. 5 illustrates an embodiment of an implant 200 having an extruded feature configured as a large proximal ring 34. The large proximal ring 34 can be a large extruded feature, such as a ring, and positioned proximally in order to assist a user, such as a clinician, with properly inserting the implant 200. For example, the large proximal ring 34 can be used as a reference hard stop for placement of the implant 200 which can assist in preventing over-insertion of the implant 200. Improperly placed implants can at least cause either damage to the eye or prevent the implant from performing efficiently and effectively. Therefore, the large proximal ring 34 can be beneficial in assisting a clinician with properly placing the implant 200 for allowing the implant 200 to efficiently and effectively reduce IOP without causing significant damage to the eye.
As shown in FIG. 5, the large proximal ring 34 can include at least one cutout 35. The cutout 35 can be oriented to face the iris when the implant 200 is implanted in the eye. This can allow the cutout 35 to at least minimize contact between the implant 200, such as the large ring 34, and the iris. In addition, the implant 200 can also include one or more extruded features, such as rings 28, and fenestrations 23 for at least assisting in promoting fluid flow through the implant, including distally directed fluid flow.
FIGS. 6A and 6B illustrate an embodiment of an implant 300 having a multitude of micro-channels 36. The micro-channels 36 can have a small diameter, such as no greater than microns, and can provide a mechanism for allowing fluid transport through the implant 300. The micro-channels 36 can run either axially along the length of the implant or radially along the length of the implant 300 which can form a meshwork of micro-channels 36. In some embodiments, the micro-channels 36 which make up the meshwork of micro-channels 36 can vary in size and shape.
In some embodiments, micro-channels 36 can be sized and configured such that they restrict fluid flow through the micro-channels 36 similar to a valve. For example, when the pressure in the anterior chamber drops below 12 mmHg the micro-channels 36 can at least reduce the amount of fluid flow through the micro-channel lumens, including preventing fluid flow altogether. By at least reducing the amount of fluid flow through the micro-channels 36 when pressure drops in the anterior chamber, the implant 300 can assist in preventing the eye from becoming hypotonous. By way of further example, when the pressure in the anterior chamber is above 12 mmHg, fluid can be allowed to flow through the micro-channels 36, such as to assist in reducing IOP.
The micro-channels 36 can increase in size from the proximal end to the distal end of the implant 300, which can assist in promoting distally directed fluid flow. Alternatively or in addition, one or more fenestrations 28 or micro-channels 36 that are larger in diameter can be placed at or near the middle portion of the implant 300 where an increase in tenting can occur.
In some embodiments, the micro-channels 36 or fenestrations 28 of the implant 300 can either form or intercept a bifurcated or trifurcated configuration at the distal end of the implant 300. The bifurcated or trifurcated configuration at the distal end of the implant 300 can assist in reducing pressure at the bifurcated or trifurcated locations and promote distally directed flow through the implant 300. Any number of fenestration 28 or micro-channel configurations can be implemented in an implant without departing from the scope of this disclosure.
FIG. 6B shows the proximal end of the implant 300 which can have one or more fenestrations 28 or micro-channels 36 extending through a proximal outer wall of the implant 300. The implant 300 can also include a distal outer wall having either one or more fenestrations 28 or micro-channels 36 extending therethrough.
As shown in at least FIGS. 3A-6B, at least one of the proximal end and distal end of the implant can have either a radiused edge 38 or chamfered edge 39. The radiused edges 38 and chamfered edges 39 can assist in inserting the implants into the eye and preventing damage to the at least during and after implantation of the implant in the eye. Any one implant can include any one of a variety of shaped and sized radiused edge 38 or chamfered edge 39, including along any extruded feature, proximal end or distal end, for at least assisting with implanting the implant and preventing damage to the eye without departing from the scope of this disclosure.
FIGS. 7A and 7B illustrate an embodiment of an implant 400 having a beveled 40 proximal end. The bevel 40 can be oriented such that the elliptical face of the bevel 40 can face away from the iris in order to at least minimize occlusion of the main inlet port 26, such as by the iris. The beveled 40 proximal end can also include at least one micro-channel 36 or fenestration 28 similar to the embodiment described in FIGS. 6A and 6B. In addition, although shown as having only a beveled 40 proximal end, any one implant can have either a beveled 40 proximal end or a beveled 40 distal end.
FIGS. 8A and 8B illustrate an embodiment of an implant 500 having a wave-cut 42 proximal end including at least one fenestration 28 adjacent the proximal end of the implant 500. At least one of the wave-cut 42 proximal end and fenestrations 28 can assist in preventing occlusion of the proximal end of the implant 500, such as by the iris or surrounding tissue. Additionally, the fenestrations 28 adjacent the proximal end of the implant 500 can provide another inlet for aqueous fluid to enter the implant 500, such as in the event the main inlet port 26 is occluded. The wave-cut 42 proximal end and proximal fenestrations 28 can be included in any implant embodiment for at least assisting in fluid flow through the proximal end of the implant.
FIG. 9 illustrates an embodiment of an implant 600 including a receiving port 44 for receiving one or more drugs, such as drugs for reducing fibrotic and inflammatory tissue response. For example, the one or more drugs can be released by the implant 600 into the eye, such as during and after implantation of the implant 600 in the eye. The receiving port 44 can be positioned anywhere along the implant 600, including the middle portion, as shown in FIG. 9. The position of the receiving port 44 along the implant 600 can depend on a number of factors, including where the one or more drugs received by the receiving port 44 are to be dispensed from the implant 600. In addition, the position of the receiving port 44 along the implant 600 can depend on the availability of the receiving port 44 to be accessed by a clinician either during or after implantation of the implant 600 for delivering one or more drugs to the receiving port 44. It can be beneficial to position the receiving port 44 along the implant 600 in order to allow a needle to locate the receiving port 44 and properly deliver one or more drugs to the receiving port 44, such as while the implant 600 is at least partially implanted in the eye.
Some method embodiments can include one or more time points after implantation of the implant 600 at which time the physician can locate the receiving port 44 of the implant 600, such as via an ab externo approach, in order to deliver one or more drugs or other substances to the implant 600. For example, the physician can use a needle or other delivery device to pierce across the sclera and into the implant 600, such as into the receiving port 44. The physician can then deliver one or more drugs or other substances through the receiving port 44 and into the implant 600. The implant 600 can then deliver the one or more drugs or other substances to the eye, such as to the suprachoroidal space. For example, one or more intraocular or intravitreal medications can be delivered to the implant 600, such as via the receiving port 44, at regular or defined time intervals (e.g., once a week, once a month, once every 10 days, etc.).
In some implementations, the implant 600 can include one or more stabilization features, such as wings 46, as shown in FIG. 9. The stabilization features, such as the wings 46, can assist in orienting and maintaining the implant 600 in position relative to its implantation site. This can assist in allowing the receiving port 44 to be accessible, such as with a needle, while the implant 600 is at least partially implanted in the eye. In some implementations, the receiving port 44 can be color coded or marked in such a way that allows a clinician to locate the receiving port. For example, the receiving port 44 can be made out of a radio-opaque material or any material that allows viewing of the material with one or more medical equipment, such as x-ray or ultrasound, for locating the receiving port and properly delivering one or more drugs into the receiving port 44.
The features and profiles of the implants described herein can be formed by one or more of a variety of manufacturing methods. For example, the implant can be formed by laser cutting a tube made out of a medical grade material, such as those discussed above. In addition, the implant can be injection molded. The implant can vary in dimensions in order to accommodate various sized implantation sites and applications. For example, the implant can be approximately 0.15 to 0.35 inches in length, and the extruded features, including rings, can have an outer diameter of approximately 0.010 to 0.030 inches and a length of approximately 0.002 to 0.008 inches. In addition, the large proximal ring can have an outer diameter of approximately 0.01 to 0.03 inches and a length of approximately 0.005 to 0.015 inches. Additionally, the implant body can have an outer diameter of approximately 0.012 to 0.022 inches and an inner diameter of approximately 0.008 to 0.018 inches. Furthermore, the fenestrations can have a diameter of approximately 0.001 to 0.008 inches. The distal end can have a radius of approximately 0.001 to 0.003 inches and the proximal end can have a radius of approximately 0.001 to 0.003 inches.
In addition, a delivery system can be used to deliver an implant 20, including at least implants 100, 200, 300, 400, 500 and 600 described herein, into the eye in order to allow the implant 20 to at least provide fluid communication between the anterior chamber and the suprachoroidal or supraciliary space. FIG. 10 shows an embodiment of a delivery system 50 that can be used to deliver the implant 20 into the eye. It should be appreciated that the delivery systems 50 described herein provide some examples, and variations in the structure, shape and actuation of the delivery system 50 are possible.
The delivery system 50 can include a proximal handle component 52 and a distal delivery component 54. The proximal handle component 52 can include an actuator 56, such as a button, to control the release of an implant 20 from the delivery component 54 into the target location in the eye. In addition, the actuator 56 can vary in structure.
An embodiment of the delivery component 54 can include an elongate applier in the form of a guidewire 58 that inserts longitudinally through an internal lumen 21 of the implant 10 and a “stopper” or sheath 60 positioned axially over the guidewire 58. The sheath 60 can aid in the release of the implant 20 from the delivery component 54 into the target location in the eye. The actuator 56 can be used to control movement or relative movement of the guidewire 58 and/or the sheath 60. For example, the sheath 60 can be fixed relative to the handle component 52 and act as a stopper that impedes the implant 20 from moving in a proximal direction as the guidewire 58 is withdrawn proximally from the implant 20 upon actuation of the actuator 56. In a first state, the guidewire 58 can be extended distally relative to the sheath 60. Actuation of the actuator 56, such as by pressing the actuator 56, can cause the guidewire 58 to slide proximally into the sheath 60. This can effectively disengage the implant 20 off the distal end of the guidewire 58 and releases the implant 20 in a controlled fashion such that the target positioning of the implant 20 is maintained.
FIG. 11 shows an enlarged view of an implant 20 mounted on a delivery component 54 for inserting the implant 20 into the eye. The implant 20 can be mounted on a distal region of a guidewire 58. The sheath 60 can be sized and shaped to receive or abut a portion of the proximal end of the implant 20. In this embodiment, upon actuation of the actuator 56, the guidewire 58 can slide in the proximal direction (arrow P) into the sheath 60. The proximal end of the implant 20 can abut the distal edge of the sheath 60 to prevent the implant 20 from sliding in the proximal direction. This can effectively disengage the implant 20 off the distal end of the guidewire 58 and controllably release the implant 20 into the eye tissue.
The delivery system 50 can also assist in providing fluid delivery into the eye during or after implantation of the implant 20. The delivered fluid can vary and can include a viscoelastic, drugs, stem cells, or a combination thereof. The delivery of the implant 20 can be in combination with retinal or macula therapy. A fluid delivery feature can include an elongated tube 80 that extends outward from the handle 52. The tube 80 can extend through the handle 52 and can have an internal lumen that communicates at a distal end with the proximal end of an internal lumen in the guidewire 58. One or more outlet openings, such as slots 70, can be located on the distal region of the guidewire 58. The tube 80 can be connected at a proximal end to a source of fluid so as to provide a pathway for the fluid to be delivered to the internal lumen of the guidewire via the tube 80. The fluid can then exit the guidewire via the slots 70 for delivery into the eye.
In alternate embodiments the fluid may be delivered to other sections along the axial length of the implant 20. Fenestrations or holes along the length of the implant 20 may be configured to be sufficiently large such that a fluid may be delivered through corresponding holes along the guidewire 58 and into the eye, such as into the supraciliary or suprachoroidal space surrounding the body of the implant 20, which can depend on where the implant 20 is positioned and the length of the implant 20. This can be advantageous because it can create additional space surrounding the implant 20 and improve tenting.
An embodiment of a method of delivering and implanting the implant 20 into the eye includes at least the following description. In general, one or more implants 20 can be slideably loaded on a delivery system 50 and implanted to a position which allows the implant to communicate with at least a part of the anterior chamber and either the suprachoroidal space or supraciliary space, as described herein. The implant 20 can be implanted in the eye via an ab-interno procedure through a limbal incision into the anterior chamber. The implant 20 may then be positioned in the eye so that it provides fluid communication between the anterior chamber and either the suprachoroidal space or supraciliary space, as well as provide increased separation between the sclera and choroid, as shown in FIG. 12.
For example, the guidewire 58 can be positioned on the delivery system 50 such that the distal tip of the guidewire 58, the implant 20 and the sheath 60 can penetrate through a small corneal incision in order to access the anterior chamber, such as within the limbus of the cornea. In an embodiment, the incision can be very close to the limbus, such as either at the level of the limbus or within 2 mm of the limbus in the clear cornea. The guidewire 58 can be used to make the incision or a separate cutting device can be used. For example, a knife-tipped device or diamond knife can be used to provide access into the cornea.
The corneal incision can have a size that is sufficient to permit at least the passage of the implant 20 on the guidewire 58 and sheath 60 therethrough. In at least some method embodiments, the incision can be about 1 mm in size. In another embodiment, the incision is no greater than about 2.5 mm in size. In another embodiment, the incision is no greater than about 2.85 mm and is greater than about 1.5 mm.
After insertion through the incision, the guidewire 58 can be advanced into the anterior chamber along a pathway that enables the implant 20 to be delivered to a position such that the implant 20 provides a flow passageway from the anterior chamber toward either the supraciliary or suprachoroidal space. For example, the guidewire 58 can be advanced further into the eye such that a blunt distal tip of the guidewire 58 and/or the implant 20 can seat with and penetrate at least one of the iris root, a region of the ciliary body, or the iris root part of the ciliary body near its tissue border with the scleral spur.
In some method embodiments, the guidewire 58 can approach the iris root from a same side of the anterior chamber as a deployment location such that the guidewire 58 does not have to be advanced across the iris. Alternately, the guidewire 58 can approach the deployment location from across the anterior chamber such that the guidewire 58 is advanced across the iris and/or the anterior chamber toward the opposite iris root. The guidewire 58 can approach the eye and the iris root along a variety of pathways. In some method embodiments, the guidewire 58 does not cross over the eye and does not intersect an optical axis of the eye. In other words, the corneal incision and the location where the implant 20 can be implanted, such as adjacent the iris root, can be in the same quadrant (for example, if the eye is viewed from the front and divided into four quadrants). Additionally, in some method embodiments, the pathway of the implant from the corneal incision to the iris root does not pass through the optic axis of the eye in order to avoid interfering with the pupil.
FIG. 12 shows an enlarged view of the anterior region of the eye showing the anterior chamber AC, the cornea C, the iris I, and the sclera S. In addition, the implant 20 is shown as mounted on the guidewire 58 and approaching an implantation site from the anterior chamber AC. The implant 20 and guidewire 58 can move along a pathway such that the dissection entry point of the distal tip of the guidewire 58 can penetrate the iris root IR near its junction with the scleral spur SSp or the iris root portion of the ciliary body CB or other desired location. The surgeon can rotate or reposition the handle of the delivery device 50 in order to obtain a proper approach trajectory for the distal tip of the guidewire 58, as described in further detail below.
The guidewire 58 with the implant 20 positioned thereupon can be advanced from a region of the anterior chamber, which can be viewed through a transparent zone of the cornea to a region of the anterior chamber that is obscured by the opaque zone of the cornea. The guidewire 58 and implant 20 can be advanced through the cornea until resistance is felt and a part of the delivery device can be seated at a location near the iris root, the ciliary body or the iris root portion of the ciliary body. The guidewire 58 can then be advanced further such that the guidewire 58 and implant 20 loaded thereon penetrate an area of fibrous attachment between the scleral spur and the ciliary body. This area of fibrous attachment can be approximately 1 mm. Once the distal tip of the guidewire 58 penetrates and is urged past this fibrous attachment region, the guidewire 58 can then more easily cause the sclera to peel away or otherwise separate from the ciliary body and possibly the choroid as it follows the inner curve of the sclera and enters the supraciliary or suprachoroidal space. A combination of the guidewire's tip shape, material, material properties, diameter, flexibility, compliance, coatings, pre-curvature etc. can make it more inclined to follow an implantation pathway that mirrors the curvature of the inner wall of the sclera and between tissue layers, such as between the sclera and the ciliary body and between the sclera and the choroid.
The dissection plane of the guidewire 58 and implant 20 can follow the curve of the inner scleral wall such that the implant 20 mounted on the guidewire 58 after penetrating the iris root or the iris root portion of the ciliary body can bluntly dissect the boundary between tissue layers of the scleral spur and the ciliary body such that at least the distal region of the implant 20 extends into the supraciliary space. In an embodiment, the implant 20 can be positioned such that it extends sufficiently past the scleral spur and is positioned between the tissue boundaries of the sclera and the choroid (the suprachoroidal space SChS).
Once properly positioned, the implant 20 can then be released from the guidewire 58. The implant 20 can be released, for example, by withdrawing the guidewire 58 such that the implant 20 is effectively disengaged in a controlled manner from the tip of the guidewire 58 with the sheath 60.
The implant 20 can include one or more structural features near its proximal region that aid to anchor or retain the implant 20 in the target region in the eye. The structural features can include extruded features, such as rings 28, large proximal rings 34, flanges, protrusions, wings, tines, or prongs, and the like that can lodge into the surrounding eye anatomy to retain the implant 20 in place and prevent the implant 20 from moving further into the suprachoroidal space.
While this specification contains many specifics, these should not be construed as limitations on the scope of an invention that is claimed or of what may be claimed, but rather as descriptions of features specific to particular embodiments. Certain features that are described in this specification in the context of separate embodiments can also be implemented in combination in a single embodiment. Conversely, various features that are described in the context of a single embodiment can also be implemented in multiple embodiments separately or in any suitable sub-combination. Moreover, although features may be described above as acting in certain combinations and even initially claimed as such, one or more features from a claimed combination can in some cases be excised from the combination, and the claimed combination may be directed to a sub-combination or a variation of a sub-combination. Similarly, while operations are depicted in the drawings in a particular order, this should not be understood as requiring that such operations be performed in the particular order shown or in sequential order, or that all illustrated operations be performed, to achieve desirable results. Only a few examples and implementations are disclosed. Variations, modifications and enhancements to the described examples and implementations and other implementations may be made based on what is disclosed.

## Claims

1. An ocular implant system for implanting an implant in an eye comprising:
an elongate tubular body comprising a proximal end, a distal end and an inner lumen extending at least partway between the proximal end and the distal end, the tubular body having a plurality of holes positioned along the length of the tubular body;
a plurality of fenestrations extending through an outer surface of the tubular body and intersecting with the inner lumen; and
a plurality of extruded features wherein at least one of the plurality of extruded features extends from the outer surface of the tubular body, and wherein the plurality of extruded features includes a plurality of extruded rings, and wherein each fenestration is positioned immediately adjacent an extruded ring such that each extruded ring immediately adjacent a fenestration tents eye tissue around each fenestration in a manner that results in fluid flow through at least one of the fenestrations when the elongate tubular body is implanted in an eye, and wherein the plurality of extruded rings includes at least one extruded ring positioned at a distal end of the elongate tubular body and at least one extruded ring positioned at a proximal end of the elongate tubular body;
a delivery device configured to insert the tubular body into the eye, the delivery device including:
a handle;
a guidewire that inserts longitudinally through the inner lumen of the tubular body, the guidewire having an interior lumen for passage of fluid and also having a plurality of openings through which fluid can exit the interior lumen of the guidewire;
a sheath positioned axially over the guidewire and positioned proximal of the tubular body when the tubular body is positioned on the guidewire.

2. The implant of claim 1 wherein the implant is made out of a medical grade material, including at least one of a stainless steel, polyimide, various plastics, or any number of shape memory alloys, including nitinol, and shape memory polymers.

3. The implant of claim 1 wherein at least one of the plurality of extruded features comprises a large proximal ring.

4. The implant of claim 1 wherein the plurality of fenestrations vary in at least one of size and shape.

5. The implant of claim 4 wherein the size of the fenestrations increase along a length of the implant in a distal direction.

6. The implant of claim 4 wherein the fenestrations increase in number along a length of the implant in a distal direction.

7. The implant of claim 1 wherein the plurality of rings vary in at least one of size and shape.

8. The implant of claim 7 wherein the extruded features increase in size along a length of the implant in a distal direction.

9. The implant of claim 1 wherein the implant includes at least one of a beveled proximal end and a beveled distal end.

10. The implant of claim 1 wherein at least one of the proximal end or the distal end includes at least one of a chamfered edge and radiused edge.

11. The implant of claim 1 wherein the implant is at least one of coated with a drug and comprised of a polymer combined with a drug.

12. A method of implanting an implant in an eye, comprising;
securing an implant to a delivery device configured to insert the implant into the eye, the implant comprising
an elongate tubular body including a proximal end, a distal end and an inner lumen extending at least partway between the proximal end and the distal end;
a plurality of fenestrations extending through an outer surface of the tubular body and intersecting with the inner lumen; and
an a plurality of extruded features extending from the outer surface of the tubular body, and wherein the plurality of extruded features includes a plurality of extruded rings, and wherein each fenestration is positioned immediately adjacent an extruded ring such that each extruded ring immediately adjacent a fenestration tents eye tissue around each fenestration in a manner that results in fluid flow through at least one of the fenestrations when the elongate tubular body is implanted in an eye;

the delivery device comprising:
a handle;
a guidewire that inserts longitudinally through the inner lumen of the tubular body, the guidewire having an interior lumen for passage of fluid and also having a plurality of openings through which fluid can exit the interior lumen of the guidewire;
a sheath positioned axially over the guidewire and positioned proximal of the tubular body when the tubular body is positioned on the guidewire; and

inserting the implant into the eye such that each extruded ring tents eye tissue around each of the corresponding fenestrations when the elongate tubular body is implanted in an eye in a manner that results in fluid flow through at least one of the fenestrations.