Delivery system for ocular implant

Information

  • Patent Grant
  • 9241832
  • Patent Number
    9,241,832
  • Date Filed
    Thursday, April 18, 2013
    11 years ago
  • Date Issued
    Tuesday, January 26, 2016
    8 years ago
Abstract
A delivery system is disclosed which can be used to deliver an ocular implant into a target location within the eye via an ab interno procedure. In some embodiments, the implant can provide fluid communication between the anterior chamber and the suprachoroidal or supraciliary space while in an implanted state. The delivery system can include a proximal handle component and a distal delivery component. In addition, the proximal handle component can include an actuator to control the release of the implant from the delivery component into the target location in the eye.
Description
BACKGROUND

This disclosure relates generally to methods and devices for use in delivering devices for treating glaucoma.


The mechanisms that cause glaucoma are not completely known. It is known that glaucoma results in abnormally high pressure in the eye, which leads 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 is 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 may 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. Correct placement of the implant is desired for a safe and successful surgical outcome.


In view of the foregoing, there is a need for improved delivery systems for delivering implants into the eye such as by way of an ab interno procedure.


SUMMARY

There is a need for improved delivery systems, devices and methods for the treatment of eye diseases such as glaucoma.


In a first embodiment, disclosed herein is a delivery device for delivering an ocular implant into an eye. The delivery device can include a proximal handle portion and a distal delivery portion coupled to a distal end of the handle portion and configured to releasably hold an ocular implant. In addition, the delivery portion can include a sheath positioned axially over a guidewire. The delivery device can further include an actuator coupled to a mechanism that releases the ocular implant from the delivery portion upon actuation of the actuator.


Also described herein are methods of delivering an ocular implant to a target location within an eye. In an embodiment, disclosed is a method including loading the ocular implant onto a distal delivery portion of a delivery system. The delivery system can include a proximal handle portion with the delivery portion coupled to a distal end of the handle portion. In addition, the delivery portion can be configured to releasably hold the ocular implant. The delivery portion can further include a sheath positioned axially over a guidewire. Additionally, the delivery device can include an actuator coupled to a mechanism that releases the ocular implant from the delivery portion upon actuation of the actuator. The method can further include inserting the distal delivery portion and the ocular implant into the eye through a corneal incision and positioning the ocular implant into the target location within the eye by way of an ab-interno procedure. Furthermore, the method can include actuating the actuator and releasing the ocular implant into the target location.


Other features and advantages should be apparent from the following description of various embodiments, which illustrate, by way of example, the principles of the described subject matter.





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 partial cross-sectional view of the eye showing a part of the anterior and posterior chambers of the eye and an ocular implant implanted in the eye.



FIG. 3 shows a perspective view of an embodiment of a delivery device having a proximal handle component and a distal delivery component with an ocular implant loaded onto the distal delivery component.



FIG. 4 shows a close up view of the distal end of the delivery component of FIG. 3 which illustrates the implant loaded onto a guidewire of the delivery system.



FIG. 5 shows a partial cross section view of the delivery system of FIG. 3 showing a distal portion of the handle component, including the spring-loaded actuator in a compressed configuration, and the distal delivery component.



FIG. 6 shows the partial cross section view of the delivery system of FIG. 5 with the spring-loaded actuator shown in a decompressed configuration which releases the implant from the distal delivery component.



FIG. 7 shows an embodiment of the guidewire of the delivery system having a curved configuration.



FIG. 8 shows an embodiment of the guidewire of the delivery system having a sinusoidal configuration.



FIG. 9 shows an embodiment of the guidewire of the delivery system having a length sufficient to extend from the supraciliary space down to the sub-retinal space.



FIG. 10 shows an enlarged view of the anterior region of the eye with the implant approaching the supraciliary space or suprachoroidal space from the anterior chamber.





Like reference symbols in the various drawings indicate like elements.


DETAILED DESCRIPTION


FIG. 1 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 implant 105 is positioned inside the eye such that a proximal end 110 is located in the anterior chamber 115 and a distal end 120 communicates with and/or is located in or near the supraciliary space or suprachoroidal space (sometimes referred to as the perichoroidal 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 implant 105 provides a fluid pathway between the anterior chamber 115 into the supraciliary space and toward the suprachoroidal space. The implant 105 has a distal end 120 that may be positioned in the supraciliary space or the suprachoroidal space. The implant 105 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 120 of the implant 105 is not necessarily positioned between the choroid and the sclera.


In an embodiment, the implant 105 is an elongate element having one or more internal lumens through which aqueous humor can flow from the anterior chamber 115 into the supraciliary space. The implant 105 can have a substantially uniform internal diameter along its entire length, although the shape of the implant 105 can vary along its length (either before or after insertion of the implant), as described below. Moreover, the implant 105 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. The cross-sectional shape can be selected to facilitate easy insertion into the eye. The following applications describe exemplary implants: U.S. Patent Publication Nos. 2007-0191863 and 2009-0182421. These applications are incorporated by reference in their entirety.



FIG. 2 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 (not shown) 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 I through which light passes. The volume between the iris I and the lens L is the posterior chamber PC. The volume between the iris I and the cornea is the anterior chamber AC. Both chambers are filled with a clear liquid known as aqueous humor.


The ciliary body CB continuously forms aqueous humor in the posterior chamber PC by secretion from the blood vessels. The aqueous humor flows around the lens L and iris I into the anterior chamber and exits the eye through the trabecular meshwork, a sieve-like structure situated at the corner of the iris I and the wall of the eye (the corner is known as the iridocorneal angle). Some of the aqueous humor filters 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 (the uveoscleral route).


The internal lumen of the implant 105 serves as a passageway for the flow of aqueous humor through the implant 105 directly from the anterior chamber toward or into the supraciliary or suprachoroidal space. In addition, the internal lumen of the implant 105 can be used as an access location to mount the implant 105 onto a delivery device, as described in more detail below. The internal lumen can also be used as a pathway for flowing fluid, such as an irrigation fluid or a visco-elastic substance(s), 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 suprachoroidal space.


Fluid can be flowed toward or into 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 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 a visco-elastic substance(s) 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.



FIG. 3 shows an embodiment of a delivery system 305 that can be used to deliver the implant 105 into the eye. In some embodiments, the implant 105 can provide fluid communication between the anterior chamber toward the suprachoroidal or supraciliary space while in an implanted state. It should be appreciated that these delivery systems 305 are exemplary and that variations in the structure, shape and actuation of the delivery system 305 are possible. The delivery system 305 can include a proximal handle component 310 and a distal delivery component 312. The proximal handle component 310 can include an actuator 420, such as a button, to control the release of an implant from the delivery component 312 into a target location in the eye. The actuator 420 can vary in structure and is not limited to a button.


An embodiment of the delivery component 312 includes an elongate applier in the form of a guidewire 515 and a “stopper” or sheath 510 positioned axially over the guidewire 515. The guidewire 515 can insert longitudinally through the internal lumen of the implant 105 and can assist in inserting and positioning the implant 105 into the target location. The sheath 510 can aid in the release of the implant 105 from the delivery component 312 into the target location in the eye. In addition, the actuator 420 can be used to control movement or relative movement of the guidewire 515 and/or the sheath 510. For example, the sheath 510 can be fixed relative to the handle component 310 and act as a stopper which can impede the implant 105 from moving in a proximal direction as the guidewire 515 is withdrawn proximally from the implant 105 upon actuation of the actuator 420.


For example, in a first state, the guidewire 515 can be extended distally relative to a distal end of the sheath 510. Actuation of the actuator 420, such as by pressing the actuator 420, can cause the guidewire 515 to slide proximally or retract into the sheath 510. This can effectively disengage the implant 105 off the distal end of the guidewire 515 and releases the implant 105 in a controlled fashion into the target location. Controlled disengagement of the implant 105 off the distal end of the guidewire 515 can assist in ensuring that positioning of the implant 105 within the target location is maintained.



FIG. 4 shows an embodiment of the implant 105 mounted on the delivery component 312 of the delivery system 305. More specifically, the implant 105 can be mounted on the distal region of the guidewire 515, as shown in FIG. 4. In addition, the sheath 510 can be sized and shaped to receive or abut a portion of the proximal end of the implant 105. In this embodiment, upon actuation of the actuator 420, the guidewire 515 can slide in a proximal direction (arrow P) into the sheath 510 which can allow the proximal end of the implant 105 to abut the distal end of the sheath 510 and prevent the implant 105 from sliding in the proximal direction. This can effectively disengage the implant 105 off the distal end of the guidewire 515 and controllably releases the implant 105 into the target location within the eye.


In some embodiments, the actuator 420 can be a push-button that is coupled to a spring-activated mechanism. Upon applying a force onto the actuator 420, the spring mechanism can retract the guidewire 515 toward and/or into the sheath 510 which can release the implant 105 from the guidewire 515. The mechanism by which the guidewire 515 can be withdrawn into the sheath 510 can be a spring activated assembly or any of a variety of mechanisms that allow the guidewire to retract upon activation of an actuator.



FIG. 5 shows an embodiment of a portion of the delivery system 305 in cross-section with the implant 105 loaded onto the guidewire 515. The delivery system 305 can include a front spring 550 which can assist in positioning the guidewire 515. For example, the front spring 550 can be compressed or charged which can allow the guidewire 515 to be positioned in an extended state relative to the handle 310. When the guidewire 515 is in an extended state, the guidewire 515 can be loaded with the implant 105, as shown in FIG. 5.


The delivery system 305 can include a variety of mechanisms for assisting in the positioning of the guidewire 515. For example, the delivery system 305 can include a feature which can interact with the actuator 420 in order to allow the actuator to assist in positioning the guidewire 515. For example, the guidewire 515 can be attached at a proximal end to a piston 560 having a de-tent latch 555. The de-tent latch 555 can interact with the actuator 420 such that upon actuation of the actuator 420, the 555 latch can release the piston 560 from a locked position and allow the piston 560 to move. For example, once the piston 560 is allowed to move, the front spring 550 can force the piston to move in a direction, such as in a proximal direction, thus causing the guidewire 515 to move in a proximal direction. Movement of the guidewire 515 in a proximal direction can allow the implant 105 loaded on the distal end of the guidewire 515 to be released from the guidewire 515.


In some embodiments, the actuator 420 can be configured such that when actuated or depressed by the user, the detent latch 555 of the piston 560 is flexed downward thereby allowing the front spring 550 to release. As the piston 560 moves proximally with the guidewire 515, the implant 105 can abut the distal end of the stopper tube 510 and release from the guidewire 515. FIG. 6 shows an embodiment of the delivery system 305 in a retracted state where the front spring 550 is in a decompressed state with the implant 105 fully released from the guidewire 515.


The travel of the piston 560 can be defined such that the guidewire 515 reaches a complete stop in the proximal direction only after the implant 105 is fully released. In addition, the force of the front spring 550 can allow withdrawal of the guidewire 515 from the implant 105 when the implant 105 is positioned in a variety of angles relative to the stopper tube 510. For example, the force of the front spring 550 can allow the withdrawal of the guidewire 515 from the implant 105 when the implant 105 is at a 45 degree angle relative to the stopper tube 510, such as what may be encountered when the implant 105 is being deployed to the supraciliary space.


In some embodiments, for example, the front spring 550 can provide approximately 1.0 to 2.0 lbf at the compressed or charged configuration which can allow the guidewire 515 to withdraw from the implant 105, including when the implant 105 is positioned at an approximate 45 degree angle relative to the stopper tube 510. However, the front spring 550 can provide any of a variety of spring force which allows the guidewire 515 to release the implant 105 positioned at a variety of angles relative to at least the stopper tube 510.


In some embodiments, the front spring 550 can create approximately 2.0 to 10.0 lbf. For example, a greater spring force of the front spring 550 can allow the guidewire 515 to retract in a variety of conditions. In addition, a lower force of the front spring, such as 0.10 to 1.0 lbf, may reduce the speed of the retraction and reduce the force required to reload the system. Any of a variety of front springs 550 can be implemented in the delivery system 350.


A dampening element, such as grease 565, may be placed between the piston 560 and inside wall of the handle 310 which can assist in providing a slower retraction of the guidewire 515. A slower retraction of the guidewire 515 can prevent or lessen any jerking motion of the delivery system 350 in the user's hands, including at the end of the piston 560 travel. This dampening grease 565 can be a silicone grease such that grease is unaffected by production level e-beam sterilization dose of 25-50 kGy. In addition, other dampening elements aside from grease 565 may be used. Alternate dampening grease such as low, medium, or high viscosity fluorocarbons may be used to alter the dampening and speed of deployment. These materials may have a larger acceptable e-beam sterilization range.


In some embodiments, the spring-activated retraction of the guidewire 515 can improve the delivery of supraciliary and suprachoroidal implants. For example, some current tools for implanting ocular implants require a sliding motion of the user's finger, such as in the range of approximately 0.280″ inches of travel, in order to release the implant. The sliding motion can be difficult for surgeons to achieve while simultaneously holding the distal end of the delivery tool steady. In contrast, the spring-activated mechanism of the present disclosure, including the spring activated push-button mechanism, allows for smaller and more ergonomic motion of the users finger to activate guidewire 515 retraction which also allows the user to maintain the distal end of the delivery device 312 in a steady position. In addition, the spring-activated mechanism of the present disclosure can allow implantation to occur more quickly and with less unwanted distal movement of the implant 105 during the guidewire retention.


The outer diameter of the guidewire 515 can be smaller than the inner diameter of the implant 105 (i.e. the fluid channel) such that the implant 105 can be loaded onto the guidewire 515 by sliding the guidewire 515 into and through an internal lumen of the implant 105. In some embodiments, the guidewire 515 can include a retention feature that can act to retain the implant 105 on the guidewire 515. For example, the guidewire 515 can include a retention feature which can assist in retaining the implant 105 on the guidewire 515 during blunt dissection and implantation in order to prevent the implant 105 from inadvertently sliding off the guidewire 515.


Before the implant 105 has been released from the guidewire 515 and implanted into the target location within the eye, the implant 105 can be moved either distally or proximally in order to adjust its placement. This can exert axial forces on the implant 105 which may cause it to slip off the guidewire 515 if it is not well retained on the guidewire 515. Therefore, in some embodiments, the guidewire 515 can include features which can assist in retaining the implant 105 onto the guidewire 515 during positioning of the implant 105, including positioning the implant 105 within the target location.



FIG. 7 shows an embodiment of a guidewire 515 which has at least one retention feature including a curved configuration 520 along a length of the guidewire 515. In some embodiments, the curved configuration 520 of the guidewire 515 can assist in facilitating entry of the implant 105 into the supracilliary space. In addition, the curvature of the guidewire 515 can change the shape of the implant 105 due to the implant 105 conforming to the curved shape of the guidewire 515 which can facilitate placement of the implant 105 into the supraciliary space as it curves along the scleral wall. The curvature radius or arc, including the curved configuration 520 of the guidewire 515, can vary and can be in the range of approximately 0.425″ to about 0.525″ with a central angle of approximately 20 degrees to approximately 40 degrees.


Additionally, any part of the guidewire 515 can have the curved configuration 520, including either the distal end or the entire length of the guidewire 515. Furthermore, the guidewire 515 can alternate between having a variety of configurations, including both straight and curved configurations. For example, the guidewire 515 can have a curved configuration in its natural state but can conform to a straight passageway, such as through the handle 310 of the delivery system 305. Therefore, the guidewire 515 can conform to a straight passageway and return to a curved configuration after having passed through the straight passageway.


In some embodiments, the guidewire 515 can have one or more cut patters along a length of the guidewire 515 which can allow the guidewire 515 to be more flexible than the material comprising the guidewire 515 can allow. For example, the distal end or tip of the guidewire 515 can include a spiral cut pattern which allows the tip of the guidewire 515 to deflect or bend in one or more of a variety of directions relative to a longitudinal axis of the guidewire 515. Furthermore, the spiral cut pattern can allow the distal end or tip of the guidewire 515 to deflect or bend to a greater degree than what the guidewire could achieve without the spiral cut pattern. These cut patterns may additionally serve as fluid conduits which can provide a passageway for substances injected into the guidewire 515 to be released to an area surrounding the guidewire, including either the implant or the eye.



FIG. 8 shows an embodiment of the guidewire 515 having at least one retention feature including a sinusoidal or S-curve configuration along a length of the guidewire 515. The sinusoidal or S-curve configuration can assist in retaining the implant 105 onto the guidewire 515, such as by at least one curved region 524 along a length of the guidewire 515. The at least one curved feature can include a protrusion, bump, etc. For example, the curved feature 524 can be configured to provide an interference fit between the guidewire 515 and the inner lumen of the implant 105.


In some embodiments, the retention feature can include an S-shaped curve along a length of the guidewire 515 which can have one or more rounded curved features 524, including bends or peaks, as shown in FIG. 8. Furthermore, each retention feature, such as curved feature 524, can form a point of contact between the inner lumen of the implant 105 and the guidewire 515. The curved features 524 of the guidewire S-curve can also reduce the risk of damaging the inner lumen of the implant 105 as the guidewire 515 is released from the implant 105. In addition, the retention features can provide a gentle interaction and retention between the guidewire 515 and the implant 105, including during removal of the guidewire 515 from the implant 105. Alternatively, the guidewire 515 retention features can be stamped, bent or shape-set, including in the shape of swells or other formations along at least a part of the length of the guidewire 515.


In an embodiment, an amount of retention force can be defined by the peak-to-peak distance between two or more retention features or curved features 524 of the implant 105. For example, larger peak-to-peak distances between the two or more curved features 524 can produce higher retention forces and smaller peak-to-peak distances can produce lower retention forces. In some embodiments, a peak-to-peak distance that is too large can cause damage to the implant 105, such as due to the guidewire 515 scraping away material along the inner lumen during removal. For example, the peak-to-peak distance may be in the range of approximately 0.0100″ to approximately 0.0200″, or in the range of approximately 0.0120″ to approximately 0.0150″. In addition, at least one retention force acting upon the implant 105, such as a polyimide implant, by the guidewire 515 of approximately 0.050-0.200 lbf can be sufficient to retain the implant 105 along the guidewire 515 during manipulation of the implant 105 prior to implantation into the target location.


In alternate embodiments, the material of the guidewire 515 can be made out of one or more flexible materials, such as metals including stainless steel or elgiloy, and polymers such as Pebax, silicones, urethanes, including a variety of combinations of materials. In some embodiments, the guidewire 515 can have a radius of curvature or arc which is less than 0.425″, such as in order to provide a small curvature of the implant 105 during insertion. This configuration can be advantageous when access between the incision and the target location requires the implant 105 to be introduced into the target location by way of a small radius, such as less than 0.425″.


Alternatively, the radius of curvature or arc of the guidewire 515 can be larger than 0.525″. Any of a variety of radius of curvature or arcs of the guidewire 515 can be implemented into any of the delivery systems 305 in order to best accommodate insertion of the implant 105 into the designated target location. For example, the radius of curvature or arc of the guidewire 515 may be such that it can allow the implant 105 to bend against the scleral wall during insertion into the supraciliary space. In addition, the retention features of the guidewire 515 can vary and can include one or more of a variety of shapes and sizes along a length of the guidewire 515. For example, the retention features can be configured to include spiral shapes, triangle peaks or the like. Additionally, the retention features can extend along one or more of a variety of planes, including more than one retention feature extending in planes positioned perpendicular relative to each other.


In addition, any number of retention features can be positioned along a length of the guidewire 515. For example, at least two, including more than five or more than ten retention features can be positioned along a length of the guidewire 515. In addition, each retention feature can provide the same or a variety of different amounts of retention forces for securing the implant 105 in a position along the guidewire 515. In some embodiments, the peak-to-peak distance between the retention features can be larger than the inner diameter of the implant 105 and can be a dimensioned larger than 0.0150″ such that it does not damage the implant 105.


In some embodiments of the delivery system 305, instead of using the guidewire 515 to provide retention of the implant 105, an additional feature of the delivery system 305 or device can be used in order to provide the necessary retention of the implant 105 onto the guidewire 515. This may include, for example, a Pebax material which can be coupled onto a part of the guidewire 515 in order to create at least a width along the guidewire 515 that is larger than the inner diameter of the implant 105. For example, the Pebax material can be crimped to the guidewire and can retain the implant 105 relative to the guidewire 515 until the implant 150 is released from the delivery system 305, such as after actuation of the actuator 420.


As shown in FIGS. 3 and 4, the delivery system 305 can include at least one fluid delivery feature which can be configured to deliver fluid into at least one of the implant or the eye, including during or after implantation of the implant 105. The delivered fluid can vary and may include a viscoelastic, drugs, stem cells, or a combination thereof. In addition, the delivery may be in combination with retinal or macula therapy.


The at least one fluid delivery feature can include an elongated tube 370 having at least one inner lumen. The elongated tube 370 can extend outward from the handle 310. In addition, the elongated tube 370 can extend through the handle 310. Additionally, the elongated tube 370 can have an internal lumen which communicates with an internal lumen of the guidewire 515.


In some embodiments, the guidewire 515 can include one or more outlet openings, such as slots 541 (FIG. 4), which can be located along a length of the guidewire 515, including along a distal region of the guidewire 515. The slots 541 can allow fluid communication between the internal lumen of the guidewire 515 and an area surrounding the guidewire 515. In addition, the outlet openings or slots 541 can also be in fluid communication with at least one inner lumen of the elongated tube 370.


In some embodiments, the elongated tube 370 can be connected at a proximal end to a source of fluid (such as via a Luer connection). The source of fluid can provide fluid into at least one inner lumen of the elongated tube 370 which can be delivered to a variety of places either within at least one of the delivery system 305, the implant 105 or the eye. For example, some of the fluid provided by the fluid source can be passed through the elongated tube 370 and exit the guidewire 515 via the slots 541 for delivery into the eye.


The size of the at least one inner lumens of the elongated tube 370 and guidewire 515 may vary. In an embodiment, the inner lumen of either the elongated tube 370 or guidewire 515 can be within a range of approximately 0.001″ to approximately 0.010″ in diameter, or approximately 0.005″ to approximately 0.009″ in diameter. In addition, the size of the inner lumen can depend on the size constraints of the outer diameter of either the elongated tube 370 or the guidewire 515.


In some embodiments, the distal slots 541 of the guidewire 515 can allow fluid from at least the fluid source to be delivered to a distal end of the implant 105, including during or after implantation of the implant 105. In addition, fluid from the fluid source can be delivered to an area adjacent the distal end of the implant in order to create an aqueous lake or create a tenting effect around at least a part of or adjacent the implant 105. The size and location of the slots 541 can be sized, shaped and positioned along the guidewire 515 in order to create a variety of fluid delivery effects. For example, at least two slots 541 can be configured symmetrically relative to the distal end of the guidewire 515 which can allow the fluid to be delivered symmetrically around or near the distal end of the implant.


In an embodiment, the flow rate of the fluid from the fluid source can be within a range of approximately 1 mg/sec to 10 mg/sec, or approximately 2 mg/sec to 5 mg/sec. In addition, the burst pressure of the delivery system 305, including the fluid delivery features, can be large enough to withstand the pressure of injecting a fluid through the lumens of the delivery system 305 and implants 105.


In some embodiments, the burst pressure of the delivery system 305 can be larger than the pressure required for the fluid to flow from the fluid source through at least the delivery system 305. For example, the burst pressure can be approximately 400 psi to approximately 1500 psi, or approximately 600 psi to approximately 1200 psi. In addition, the burst pressure required for viscoelastic flow of Healon 5 can be approximately 100 psi to approximately 500 psi, or approximately 200 psi to approximately 300 psi.


In some embodiments, fluid from the fluid source can be delivered to one or more sections along the axial length of the implant 105. For example, one or more holes along the length of the implant 105 (as shown in FIG. 4) can be configured to be sufficiently large such that a fluid may be delivered from the guidewire 515. For example, one or more slits 514 positioned along the length of the guidewire 515, such as below a loaded implant 105, can allow fluid to travel through the at least one hole along the length of the implant 105 and into the eye. For example, the fluid can flow out from the one or more holes along the length of the implant and into the supraciliary or suprachoroidal space surrounding the body of the implant 105 (depending on where the implant is positioned and the length of the implant). The release of fluid through the at least one hole along the length of the implant 105 can assist in creating additional space surrounding the implant 105 which can improve tenting.


One or more drugs can be delivered to the inner lumen of the implant 105 through the one or more holes or slits 514 along the axial length of the guidewire 515. Alternatively or in addition, drugs can be delivered through the guidewire 515 slots 541 positioned at or near the distal end of the guidewire 515 which can dispense fluid either before or during retraction of the guidewire 515. In some instances, this can reduce the fibrotic response of the surrounding tissue to the implant 105. Additionally, the delivery of fluids may be administered through separate components that do not retain the implant 105. For example, separate tubes may be inserted into the eye alongside of the implant 105 which can deliver drugs or viscoelastic to, for example, the distal end of the implant 105.


The system may also be used for the ab-interno delivery of fluids to other locations in the eye. FIG. 9, for example, shows the guidewire 515 having a length sufficient to extend from the supraciliary space down to the sub-retinal space. Fluid delivery in the subretinal portion of the eye may be advantageous because it can allow for direct delivery of drugs to the macula for diseases such as age related macular degeneration (AMD) or diabetic retinopathy, or the like. A variety of drugs can be delivered to the sub-retinal space, including anti-VEGF treatments or the like. Alternatively other fluids containing a stem cell therapeutic may be delivered through the guidewire 515 and into the sub-retinal or sub-macula space. These could be used to treat disease such as glaucoma, AMD, and diabetic retinopathy.


Additionally, fluid may be delivered to various anatomical structures comprising the eye. For example, fluid can be delivered to anatomical structures such as the Schlemm's Canal. By way of further example, the guidewire 515 can be passed through the Trabecular Meshwork, such as via an ab interno procedure, and into the Schlemm's Canal where viscoelastic substances can then be injected. The viscoelastic substances can then travel circumferentially around the eye for a number of hours which can dilate the Schlemm's Canal. In another embodiment, the guidewire 515 may be inserted through the sclera with the tip of the guidewire 515 just below the conjunctiva. Fluids such as viscoelastic may then be injected to create a sub-conjunctiva space which can form a filtration bleb.


A guidewire 515 assembly having an increased stiffness, such as one made from Nitinol, can be appropriately sized and delivered through an ab-interno approach. Alternate materials such as flexible polymers including Pebax, silicone, and urethane, can also be used. The ab-interno procedure can offer a patient significant reductions in complications and risks that are associated with the current ab-externo procedures, including conjunctivitis.


An example method of delivering and implanting the ocular implant 105 in the eye can include loading one or more implants 105 on a delivery system 305 and implanting the implants 105 by way of an ab interno procedure. The implant 105 can be implanted such that it can provide fluid communication between the anterior chamber and the supraciliary or suprachoroidal space. The implant 105 can then be secured in the eye so that it provides permanent fluid communication between the anterior chamber and the supraciliary space or suprachoroidal space.


The guidewire 515 can be positioned on the delivery system 305 such that the distal tip of the guidewire 515, the implant 105 and sheath 510 can penetrate through a small corneal incision in order to access the anterior chamber, such as along 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 515 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 initially enter the cornea.


The corneal incision can have a size that is sufficient to permit passage of at least the implant 105. In an embodiment, the incision can be approximately 1 mm in size. In another embodiment, the incision can be no greater than approximately 2.85 mm in size. In another embodiment, the incision is no greater than approximately 2.85 mm and can be greater than approximately 1.5 mm.


After insertion through the incision, the guidewire 515 can be advanced into the anterior chamber along a pathway that enables the implant 105 to be delivered to a position such that the implant 105 provides a flow passageway from the anterior chamber toward the suprachoroidal space. The guidewire 515 can be advanced further into the eye such that the blunt distal tip of the guidewire 515 and/or the implant 105 seats with and can penetrate the iris root IR or a region of the ciliary body CB or the iris root part of the ciliary body near its tissue border with the scleral spur.


The guidewire 515 can approach the iris root from the same side of the anterior chamber as the deployment location such that the guidewire 515 does not have to be advanced across the iris. Alternately, the guidewire 515 can approach the location from across the anterior chamber such that the guidewire 515 is advanced across the iris and/or the anterior chamber toward the opposite iris root. The guidewire 515 can approach the eye and the iris root along a variety of pathways. For example, the guidewire 515 can be advanced through the anterior chamber such that it does not intersect the optical axis of the eye. In other words, the corneal incision and the location where the implant 105 is implanted at the iris root can be in the same quadrant (if the eye is viewed from the front and divided into four quadrants).



FIG. 10 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, FIG. 10 shows the implant 105 loaded onto a guidewire 515 and approaching the supraciliary space or suprachoroidal space from the anterior chamber AC. The implant 105 mounted on the guidewire 515 can move along a pathway such that the dissection entry point of the distal tip of the guidewire 515 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 310 of the delivery system 305 in order to obtain a proper approach trajectory for the distal tip of the guidewire 515, as described in further detail below.


The guidewire 515 with the implant 105 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 may be obscured by an opaque zone of the cornea. The guidewire 515 and implant 105 can be advanced through the cornea C until resistance is felt and the delivery device can be seated at a location near the iris root IR, the ciliary body or the iris root portion of the ciliary body. The guidewire 515 can then be advanced further such that the guidewire 515 and implant 105 loaded thereon can penetrate an area of fibrous attachment between the scleral spur SSP and the ciliary body CB. This area of fibrous attachment can be approximately 1 mm in length. Once the distal tip of the guidewire 515 penetrates and is urged past this fibrous attachment region, the guidewire 515 can then more easily cause the sclera S to peel away or otherwise separate from the ciliary body CB and possibly the choroid as the guidewire 515 follows the inner curve of the sclera S and enters the supraciliary 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 which 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 515 and implant 105 can follow the curve of the inner scleral wall such that the implant 105 mounted on the guidewire 515 can bluntly dissect the boundary between the scleral spur SSp and the ciliary body CB such that a distal region of the implant extends into the supraciliary space. For example, the dissection plane can be formed by the guidewire 515 and implant 105 after either the guidewire 515 or implant 105 penetrates the iris root or the iris root portion of the ciliary body. In an embodiment, the implant 105 can be positioned such that it does not extend anteriorly past the scleral spur SSP far enough to reach or otherwise contact the choroid. In addition, in some embodiments, the distal end of the implant 105 does not reach and cannot contact the choroid. In another embodiment, the implant 105 can extend sufficiently past the scleral spur SSP such that it can be positioned between the tissue boundaries of the sclera and the choroid (the suprachoroidal space).


In some embodiments, at least approximately 1 mm to approximately 2 mm of the implant (along the length) remains in the anterior chamber AC. The implant 105 can be positioned so that a portion of the implant 105 is sitting on top of the ciliary body CB. The ciliary body CB may act as a platform off of which the implant 105 can cantilever towards or into the suprachoroidal space SChS although the implant may not actually enter the suprachoroidal space. The implant 105 can lift or “tent” the sclera S outward such that a tented chamber is formed around the distal end of the implant 105. It should be appreciated that the actual contour of the tented region of tissue may differ in the actual anatomy. In some embodiments, the distal end of the implant 105 does not extend far enough to reach the choroid. In another embodiment, the distal end of the implant 105 reaches the choroid and can contact the choroid.


Once properly positioned, the implant 105 can then be released from the guidewire 515. The implant 105 can be released for example by withdrawing the guidewire 515 such that the implant 105 is effectively disengaged in a controlled manner from the tip of the guidewire 515 with the assistance of the sheath 510, as described above.


The implant 105 can include one or more structural features near its proximal region that aid to anchor or retain the implant 105 in the target location in the eye. The structural features can include flanges, protrusions, wings, tines, or prongs, and the like which can lodge into surrounding eye anatomy in order retain the implant 105 in place and prevent the implant 105 from moving further into the suprachoroidal space SchS.


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. A delivery device for delivering an ocular implant into an eye, the delivery device comprising: a proximal handle portion;a distal delivery portion coupled to a distal end of the handle portion and configured to releasably hold an ocular implant, the delivery portion comprising a sheath positioned axially over a guidewire that inserts through the ocular implant when the ocular implant is mounted on the guidewire such that only the guidewire is inserted into the ocular implant; andan actuator coupled to a mechanism that releases the ocular implant from the delivery portion upon actuation of the actuator, wherein the guidewire is coupled to a part of the mechanism which includes a spring, wherein actuation of the actuator causes the spring to retract the guidewire; anda dampener coupled to the handle portion, the dampener adapted to dampen retraction of the guidewire upon actuation of the actuatorwherein the guidewire includes at least one non-spiraled curved section that at least partially retains the implant on the guidewire during delivery into the eye, wherein the curved section forms a radius of curvature that is tighter than a radius of curvature of the entire guidewire.
  • 2. The delivery device of claim 1, wherein a distal end of the guidewire extends distally from a distal end of the sheath when the spring is in a first formation.
  • 3. The delivery device of claim 2, wherein the distal end of the guidewire proximally retracts from the distal end of the sheath when the spring is in a second formation.
  • 4. The delivery device of claim 3, wherein actuation of the actuator causes the spring to transition between the first formation and the second formation.
  • 5. The delivery device of claim 1, wherein a distal end of the sheath at least one of receives or abuts a proximal end of the ocular implant and prevents the ocular implant from sliding in a proximal direction as the guidewire proximally retracts.
  • 6. The delivery device of claim 1, wherein the curved section includes a radius of curvature in the range of 0.425 inches to 0.525 inches with a central angle in the range of 20 degrees to 40 degrees.
  • 7. The delivery device of claim 1, wherein the guidewire includes at least one inner lumen.
  • 8. The delivery device of claim 7, wherein the guidewire includes at least one opening along a length of the guidewire which provides fluid communication between the inner lumen of the guidewire and an area surrounding the guidewire.
  • 9. The delivery device of claim 8, wherein the implant includes at least one hole along a length of the ocular implant which provides fluid communication between the inner lumen of the implant and an area surrounding the ocular implant.
  • 10. The delivery device of claim 1, wherein the delivery device includes at least one fluid delivery feature which delivers fluid from a fluid source to at least one of the ocular implant or the eye.
  • 11. The delivery device of claim 10, wherein the fluid from the fluid source includes one or more of a viscoelastic, a drug and a stem cell.
REFERENCE TO PRIORITY DOCUMENT

This application claims priority benefit under 35 U.S.C. §119(e) of U.S. Provisional Patent Application Ser. No. 61/637,789, filed Apr. 24, 2012, and entitled “Delivery System for Ocular Implant.” The priority of the filing date is hereby claimed, and the disclosure of the provisional patent application is hereby incorporated by reference in its entirety.

US Referenced Citations (318)
Number Name Date Kind
2990670 Kingsbury Jul 1961 A
3439675 Cohen Apr 1969 A
3767759 Wichterle Oct 1973 A
3788327 Donowitz et al. Jan 1974 A
3915172 Wichterle et al. Oct 1975 A
4037604 Newkirk Jul 1977 A
4402681 Haas et al. Sep 1983 A
4457757 Molteno Jul 1984 A
4521210 Wong Jun 1985 A
4554918 White Nov 1985 A
4604087 Joseph Aug 1986 A
4617715 Koistinen et al. Oct 1986 A
4634418 Binder Jan 1987 A
4722724 Schocket Feb 1988 A
4750901 Molteno Jun 1988 A
4787885 Binder Nov 1988 A
4826478 Schocket May 1989 A
4846172 Berlin Jul 1989 A
4863457 Lee Sep 1989 A
4886488 White Dec 1989 A
4900300 Lee Feb 1990 A
4946436 Smith Aug 1990 A
4968296 Ritch et al. Nov 1990 A
5041081 Odrich Aug 1991 A
5071408 Ahmed Dec 1991 A
5073163 Lippman Dec 1991 A
5092837 Ritch et al. Mar 1992 A
5127901 Odrich Jul 1992 A
5171213 Price, Jr. Dec 1992 A
5178604 Baerveldt et al. Jan 1993 A
5180362 Worst Jan 1993 A
5284476 Koch Feb 1994 A
5300020 L'Esperance, Jr. Apr 1994 A
5338291 Speckman et al. Aug 1994 A
5342370 Simon et al. Aug 1994 A
5346464 Camras Sep 1994 A
5370607 Memmen Dec 1994 A
5372577 Ungerleider Dec 1994 A
5397300 Baerveldt et al. Mar 1995 A
5433701 Rubinstein Jul 1995 A
5443505 Wong et al. Aug 1995 A
5454746 Guegan et al. Oct 1995 A
5476445 Baerveldt et al. Dec 1995 A
5558629 Baerveldt et al. Sep 1996 A
5558630 Fisher Sep 1996 A
RE35390 Smith Dec 1996 E
5601094 Reiss Feb 1997 A
5626558 Suson May 1997 A
5626559 Solomon May 1997 A
5651782 Simon et al. Jul 1997 A
5676944 Alvarado et al. Oct 1997 A
5702414 Richter et al. Dec 1997 A
5704907 Nordquist et al. Jan 1998 A
5713844 Peyman Feb 1998 A
5741292 Mendius Apr 1998 A
5743868 Brown et al. Apr 1998 A
5752928 de Roulhac et al. May 1998 A
5792075 Schwager Aug 1998 A
5807244 Barot Sep 1998 A
5807302 Wandel Sep 1998 A
5868697 Richter et al. Feb 1999 A
5882327 Jacob Mar 1999 A
5893837 Eagles et al. Apr 1999 A
5941250 Aramant et al. Aug 1999 A
5968058 Richter et al. Oct 1999 A
6007510 Nigam Dec 1999 A
6007511 Prywes Dec 1999 A
6036678 Giungo Mar 2000 A
6050970 Baerveldt Apr 2000 A
6050999 Paraschac et al. Apr 2000 A
6077299 Adelberg et al. Jun 2000 A
6102045 Nordquist et al. Aug 2000 A
6142969 Nigam Nov 2000 A
6152918 Padilla et al. Nov 2000 A
6174307 Daniel et al. Jan 2001 B1
6186974 Allan et al. Feb 2001 B1
6203513 Yaron et al. Mar 2001 B1
6221078 Bylsma Apr 2001 B1
6251090 Avery et al. Jun 2001 B1
6261256 Ahmed Jul 2001 B1
6264668 Prywes Jul 2001 B1
6270472 Antaki et al. Aug 2001 B1
6331313 Wong et al. Dec 2001 B1
6375642 Grieshaber et al. Apr 2002 B1
6383219 Telandro et al. May 2002 B1
6450984 Lynch et al. Sep 2002 B1
6464724 Lynch et al. Oct 2002 B1
6468283 Richter et al. Oct 2002 B1
6471666 Odrich Oct 2002 B1
6471777 Kobayashi et al. Oct 2002 B1
6494857 Neuhann Dec 2002 B1
6508779 Suson Jan 2003 B1
6510600 Yaron et al. Jan 2003 B2
6524275 Lynch et al. Feb 2003 B1
6533768 Hill Mar 2003 B1
6537568 Olejnik et al. Mar 2003 B2
6544208 Ethier et al. Apr 2003 B2
6544249 Yu et al. Apr 2003 B1
6558342 Yaron et al. May 2003 B1
6561974 Grieshaber et al. May 2003 B1
6579256 Hughes Jun 2003 B2
6589203 Mitrev Jul 2003 B1
6595945 Brown Jul 2003 B2
6626858 Lynch et al. Sep 2003 B2
6638239 Bergheim et al. Oct 2003 B1
6648283 Chase et al. Nov 2003 B2
6666841 Gharib et al. Dec 2003 B2
6676607 de Juan, Jr. et al. Jan 2004 B2
6699210 Williams et al. Mar 2004 B2
6699211 Savage Mar 2004 B2
6719750 Varner et al. Apr 2004 B2
6726664 Yaron et al. Apr 2004 B2
6726676 Stegmann et al. Apr 2004 B2
6730056 Ghaem et al. May 2004 B1
6736791 Tu et al. May 2004 B1
6741666 Henry et al. May 2004 B1
6752753 Hoskins et al. Jun 2004 B1
6780164 Bergheim et al. Aug 2004 B2
6783544 Lynch et al. Aug 2004 B2
6786888 Zadno-Azizi et al. Sep 2004 B1
6827699 Lynch et al. Dec 2004 B2
6827700 Lynch et al. Dec 2004 B2
6881197 Nigam Apr 2005 B1
6881198 Brown Apr 2005 B2
6939298 Brown et al. Sep 2005 B2
6955656 Bergheim et al. Oct 2005 B2
6962573 Wilcox Nov 2005 B1
6966888 Cullen et al. Nov 2005 B2
6969384 de Juan, Jr. et al. Nov 2005 B2
6981958 Gharib et al. Jan 2006 B1
6989007 Shadduck Jan 2006 B2
7041077 Shields May 2006 B2
7090681 Weber et al. Aug 2006 B2
7094225 Tu et al. Aug 2006 B2
7135009 Tu et al. Nov 2006 B2
7160264 Lisk, Jr. et al. Jan 2007 B2
7163543 Smedley et al. Jan 2007 B2
7186232 Smedley et al. Mar 2007 B1
7192412 Zhou et al. Mar 2007 B1
7195774 Carvalho et al. Mar 2007 B2
7207965 Simon Apr 2007 B2
7220238 Lynch et al. May 2007 B2
7273475 Tu et al. Sep 2007 B2
7291125 Coroneo Nov 2007 B2
7297130 Bergheim et al. Nov 2007 B2
7331984 Tu et al. Feb 2008 B2
7431710 Tu et al. Oct 2008 B2
7488303 Haffner et al. Feb 2009 B1
7563241 Tu et al. Jul 2009 B2
7708711 Tu et al. May 2010 B2
7850637 Lynch et al. Dec 2010 B2
7857782 Tu et al. Dec 2010 B2
7867186 Haffner et al. Jan 2011 B2
7867205 Bergheim et al. Jan 2011 B2
8075511 Tu et al. Dec 2011 B2
8128588 Coroneo Mar 2012 B2
8172899 Silvestrini et al. May 2012 B2
8337393 Silverstrini et al. Dec 2012 B2
8702727 Harrington et al. Apr 2014 B1
20020013546 Grieshaber et al. Jan 2002 A1
20020013572 Berlin Jan 2002 A1
20020072673 Yamamoto et al. Jun 2002 A1
20020087111 Ethier et al. Jul 2002 A1
20020111608 Baerveldt et al. Aug 2002 A1
20020128613 Nakayama Sep 2002 A1
20020133168 Smedley et al. Sep 2002 A1
20020143284 Tu et al. Oct 2002 A1
20020177856 Richter et al. Nov 2002 A1
20020188308 Tu et al. Dec 2002 A1
20020193725 Odrich Dec 2002 A1
20020193804 Tickle Dec 2002 A1
20030028127 Balzum et al. Feb 2003 A1
20030028228 Sand Feb 2003 A1
20030055372 Lynch et al. Mar 2003 A1
20030060752 Bergheim et al. Mar 2003 A1
20030097151 Smedley et al. May 2003 A1
20030097171 Elliott May 2003 A1
20030135149 Cullen et al. Jul 2003 A1
20030181848 Bergheim et al. Sep 2003 A1
20030187384 Bergheim et al. Oct 2003 A1
20030208163 Yaron et al. Nov 2003 A1
20030229303 Haffner et al. Dec 2003 A1
20030236483 Ren Dec 2003 A1
20030236484 Lynch et al. Dec 2003 A1
20040015140 Shields Jan 2004 A1
20040024345 Gharib et al. Feb 2004 A1
20040088048 Richter et al. May 2004 A1
20040092856 Dahan May 2004 A1
20040097984 Zapata May 2004 A1
20040102729 Haffner et al. May 2004 A1
20040111050 Smedley et al. Jun 2004 A1
20040127843 Tu et al. Jul 2004 A1
20040147870 Burns et al. Jul 2004 A1
20040148022 Eggleston Jul 2004 A1
20040193095 Shadduck Sep 2004 A1
20040193262 Shadduck Sep 2004 A1
20040210181 Vass et al. Oct 2004 A1
20040210185 Tu et al. Oct 2004 A1
20040216749 Tu Nov 2004 A1
20040225250 Yablonski Nov 2004 A1
20040236343 Taylor et al. Nov 2004 A1
20040249333 Bergheim et al. Dec 2004 A1
20040254517 Quiroz-Mercado et al. Dec 2004 A1
20040254519 Tu et al. Dec 2004 A1
20040254520 Porteous et al. Dec 2004 A1
20040254521 Simon Dec 2004 A1
20040260228 Lynch et al. Dec 2004 A1
20050008673 Snyder et al. Jan 2005 A1
20050049578 Tu et al. Mar 2005 A1
20050085892 Goto Apr 2005 A1
20050090806 Lynch et al. Apr 2005 A1
20050090807 Lynch et al. Apr 2005 A1
20050107734 Coroneo May 2005 A1
20050119601 Lynch et al. Jun 2005 A9
20050119636 Haffner et al. Jun 2005 A1
20050119737 Bene et al. Jun 2005 A1
20050125003 Pinchuk et al. Jun 2005 A1
20050143817 Hunter et al. Jun 2005 A1
20050149080 Hunter et al. Jul 2005 A1
20050171507 Christian et al. Aug 2005 A1
20050175663 Hunter et al. Aug 2005 A1
20050181011 Hunter et al. Aug 2005 A1
20050181977 Hunter et al. Aug 2005 A1
20050182350 Nigam Aug 2005 A1
20050191331 Hunter et al. Sep 2005 A1
20050192527 Gharib et al. Sep 2005 A1
20050197613 Sniegowski et al. Sep 2005 A1
20050209549 Bergheim et al. Sep 2005 A1
20050209550 Bergheim et al. Sep 2005 A1
20050232972 Odrich Oct 2005 A1
20050244462 Farooq Nov 2005 A1
20050250788 Tu et al. Nov 2005 A1
20050266047 Tu et al. Dec 2005 A1
20050267397 Bhalla Dec 2005 A1
20050267398 Protopsaltis et al. Dec 2005 A1
20050271704 Tu et al. Dec 2005 A1
20050273033 Grahn et al. Dec 2005 A1
20050277864 Haffner et al. Dec 2005 A1
20050283108 Savage Dec 2005 A1
20050287188 Anderson et al. Dec 2005 A1
20050288617 Yaron et al. Dec 2005 A1
20050288619 Gharib et al. Dec 2005 A1
20060020248 Prescott Jan 2006 A1
20060032507 Tu Feb 2006 A1
20060036207 Koonmen et al. Feb 2006 A1
20060069340 Simon Mar 2006 A1
20060074375 Bergheim et al. Apr 2006 A1
20060084907 Bergheim et al. Apr 2006 A1
20060116626 Smedley et al. Jun 2006 A1
20060149194 Conston et al. Jul 2006 A1
20060155238 Shields Jul 2006 A1
20060173397 Tu et al. Aug 2006 A1
20060195055 Bergheim et al. Aug 2006 A1
20060195056 Bergheim et al. Aug 2006 A1
20060200113 Haffner et al. Sep 2006 A1
20060235367 Takashima et al. Oct 2006 A1
20060241580 Mittelstein et al. Oct 2006 A1
20060241749 Tu et al. Oct 2006 A1
20060276739 Brown Dec 2006 A1
20070010827 Tu et al. Jan 2007 A1
20070088242 Coroneo Apr 2007 A1
20070088424 Greenberg et al. Apr 2007 A1
20070088432 Solovay et al. Apr 2007 A1
20070106235 Coroneo May 2007 A1
20070106236 Coroneo May 2007 A1
20070112292 Tu et al. May 2007 A1
20070118147 Smedley et al. May 2007 A1
20070141106 Bonutti et al. Jun 2007 A1
20070149915 Yablonski Jun 2007 A1
20070191863 De Juan et al. Aug 2007 A1
20070207186 Scanlon et al. Sep 2007 A1
20070233037 Gifford et al. Oct 2007 A1
20070276315 Haffner et al. Nov 2007 A1
20070276316 Haffner et al. Nov 2007 A1
20070282244 Tu et al. Dec 2007 A1
20070282245 Tu et al. Dec 2007 A1
20070293807 Lynch et al. Dec 2007 A1
20080015488 Tu et al. Jan 2008 A1
20080045878 Bergheim et al. Feb 2008 A1
20080058704 Hee et al. Mar 2008 A1
20080108933 Yu et al. May 2008 A1
20080147021 Jani Jun 2008 A1
20080195027 Coroneo Aug 2008 A1
20080200860 Tu et al. Aug 2008 A1
20080228127 Burns Sep 2008 A1
20080234624 Bergheim et al. Sep 2008 A2
20090036819 Tu et al. Feb 2009 A1
20090036840 Viray et al. Feb 2009 A1
20090043321 Conston et al. Feb 2009 A1
20090118702 Lazar May 2009 A1
20090182421 Silvestrini et al. Jul 2009 A1
20100010416 Juan, Jr. et al. Jan 2010 A1
20100134759 Silvestrini et al. Jun 2010 A1
20100137981 Silvestrini et al. Jun 2010 A1
20100152641 Yablonski Jun 2010 A1
20100211079 Aramant Aug 2010 A1
20100234790 Tu et al. Sep 2010 A1
20100274259 Yaron et al. Oct 2010 A1
20100280317 Silvestrini et al. Nov 2010 A1
20110028883 Juan, Jr. et al. Feb 2011 A1
20110028884 Theodore Coroneo Feb 2011 A1
20110087148 Silvestrini et al. Apr 2011 A1
20110087149 Theodore Coroneo Apr 2011 A1
20110087150 Theodore Coroneo Apr 2011 A1
20110087151 Theodore Coroneo Apr 2011 A1
20110098629 Juan, Jr. et al. Apr 2011 A1
20110098809 Wardle et al. Apr 2011 A1
20110112546 Juan, Jr. et al. May 2011 A1
20110238075 Clauson et al. Sep 2011 A1
20110276054 Helmy Nov 2011 A1
20110306915 De Juan, Jr. et al. Dec 2011 A1
20120035525 Silvestrini Feb 2012 A1
20120089071 Oliver et al. Apr 2012 A1
20120116504 Lyons May 2012 A1
20120123316 Horvath et al. May 2012 A1
20120123434 Grabner et al. May 2012 A1
20120271272 Hammack et al. Oct 2012 A1
20140155805 Schaller et al. Jun 2014 A1
Foreign Referenced Citations (76)
Number Date Country
0228185 Nov 1986 EP
1184010 Mar 2002 EP
1310222 May 2003 EP
1473004 Nov 2004 EP
1477146 Nov 2004 EP
1418868 Mar 2008 EP
1977724 Oct 2008 EP
2027837 Feb 2009 EP
2101891 Jan 1983 GB
2007-535386 Dec 2007 JP
2010-533565 Oct 2010 JP
2018289 Aug 1994 RU
2056818 Mar 1996 RU
2074686 Mar 1997 RU
2074687 Mar 1997 RU
2157678 Oct 2000 RU
WO-8900869 Feb 1989 WO
WO-9112046 Aug 1991 WO
WO-9219294 Nov 1992 WO
WO-9402081 Feb 1994 WO
WO-9409721 May 1994 WO
WO-9409837 May 1994 WO
WO-9413234 Jun 1994 WO
WO-9508310 Mar 1995 WO
WO-9620742 Jul 1996 WO
WO-9636377 Nov 1996 WO
WO-9823237 Jun 1998 WO
WO-9830181 Jul 1998 WO
WO-9926567 Jun 1999 WO
WO-0006223 Feb 2000 WO
WO-0064389 Nov 2000 WO
WO-0064390 Nov 2000 WO
WO-0064391 Nov 2000 WO
WO-0064393 Nov 2000 WO
WO-0064511 Nov 2000 WO
WO-0178631 Oct 2001 WO
WO-0178656 Oct 2001 WO
WO-0197727 Dec 2001 WO
WO-0236052 May 2002 WO
WO-02070045 Sep 2002 WO
WO-02074052 Sep 2002 WO
WO-02080811 Oct 2002 WO
WO-02080829 Oct 2002 WO
WO-02087418 Nov 2002 WO
WO-02087479 Nov 2002 WO
WO-02089699 Nov 2002 WO
WO-02102274 Dec 2002 WO
WO-03015659 Feb 2003 WO
WO-03015667 Feb 2003 WO
WO-03041622 May 2003 WO
WO-03073968 Sep 2003 WO
WO-03099175 Dec 2003 WO
WO-2004014218 Feb 2004 WO
WO-2004026106 Apr 2004 WO
WO-2004026347 Apr 2004 WO
WO-2004043231 May 2004 WO
WO-2004056294 Jul 2004 WO
WO-2004060219 Jul 2004 WO
WO-2004062469 Jul 2004 WO
WO-2004073552 Sep 2004 WO
WO-2004110391 Dec 2004 WO
WO-2005016418 Feb 2005 WO
WO-2005046782 May 2005 WO
WO-2005055873 Jun 2005 WO
WO-2005105197 Nov 2005 WO
WO-2005107664 Nov 2005 WO
WO-2005107845 Nov 2005 WO
WO-2006012421 Feb 2006 WO
WO-2006036715 Apr 2006 WO
WO-2007087061 Aug 2007 WO
WO-2007115259 Oct 2007 WO
WO-2007130393 Nov 2007 WO
WO-2008061043 May 2008 WO
WO-2009012406 Jan 2009 WO
WO-2009158524 Dec 2009 WO
WO-2010115101 Oct 2010 WO
Non-Patent Literature Citations (122)
Entry
Barsky et al. “Evaluation of absorbable gelatin film (Gelfilm) in cyclodialysis clefts” Arch. Ophth. 60(6): 1044-1052, 1958.
Bick MW “Use of tantalum for ocular drainage” Arch Ophthal. 42(4): 373-88 (1949).
Bietti “The present state of the use of plastics in eye surgery” Acta Ophthalmol (Copenh) 33(4):337-70 (1955).
Brown et al., “Internal Sclerectomy for Glaucoma Filtering Surgery with an Automated Trephine,” Archives of Ophthalmology, 105:133-136 (1987).
Burchfield JC, Kass MA, Wax MB. Primary valve malfunction of the Krupin eye valve with disk. J Glaucoma. Jun. 1997;6(3):152-6.
Chiou et al. “Ultrasound biomicroscopy of eyes undergoing deep sclerectomy with collagen implant” Br J Ophthalmol 80 (1996), pp. 541-544.
Chylack LT, Bellows AR. Molecular sieving in suprachoroidal fluid formation in man. Invest Ophthalmol Vis Sci 17: 420, 1978.
Classen et al. “A histopathologic and immunohistorchemical analysis of the filtration bleb after unsuccessful glaucoma seton implantation” Am. J. Ophthalmol. 122:205-12 (1996).
Cohen et al. “First day post-operative review following uncomplicated phacoemulsification” Eye 12(4):634-6 (1998).
Collaborative Normal-Tension Study Group. Comparison of glaucomatous progression between untreated patients with normal-tension glaucoma and patients with therapeutically reduced intraocular pressures. Am J Ophthalmol 1998;126:487-97.
Congdon N, O'Colmain B, Klaver CC, et al. Causes and prevalence of visual impairment among adults in the United States. Arch Ophthalmol 2004;122:477-85.
Coote. “Glaucoma Hollow Fiber Filters—A New Glaucoma Seton. Preliminary Results.” J. Glaucoma. vol. 8 No. 1 Supplement (1999):p. S4.
Cullen, et al. “Anterior Chamber of Frontal Sinus Shunt for the Diversion of Aqueous Humor: A Pilot Study in Four Normal Dogs”. Veterinary Ophthalmology. vol. 1. No. 1. (1998):31-39.
Demailly et al. “Non-penetrating deep sclerectomy (NPDS) with or without collagen device (CD) in primary open-angle glaucoma: middle-term retrospective study” International Ophthalmology 20: 131-140, 1997.
Derwent English abstract for EP 1184010, published Mar. 6, 2002 entitled: “Drainage unit for an eye, consists of a hollow line, a distribution member, and a pressure relief valve which only allows water to leave the eye chamber above a certain pressure,” Accession Nbr. 12409716 [351].
Dinakaran et al. “Is the first post-operative day review necessary following uncomplicated phacoemulsification surgery?” Eye, 14(3A):364-6 (2000).
Draeger “Chirurgische Maβnahmen bei kongenitalem Glaukom” (Surgical Interventions in Congenital Glaucoma) Klin Monatsbl Augenheilkd 1993; 202(5): 425-427 [Article in German with English summary included].
Einmahl et al. “Evaluation of a novel biomaterial in the suprachoroidal space of the rabbit eye” Invest Ophthalmol Vis Sci. 43:1533-1539 (2002).
Ellis, RA “A Reduction of Intraocular Pressure Using Plastics in Surgery” Am J Ophth. 50; 1960, 733-742.
Emi et al. “Hydrostatic pressure of the suprachoroidal space” Invest. Ophthal. Visual Sci. 30(2):233-238 (1989).
Fanous MM, Cohn RA. Propionibacterium endophthalmitis following Molteno tube repositioning. J Glaucoma. Aug. 1997;6(4):201-2.
Friedman DS, Wolfs RC, O'Colmain BJ, et al. Prevalence of open-angle glaucoma among adults in the United States. Arch Ophthalmol 2004;122:532-8.
Fuchs E. “Detachment of the choroid inadvertently during cataract surgery” [German] von Graefes Arch Ophthalmol, 51:199-224 (1900) [Article in German with English summary].
Gills et al. “Action of cyclodialysis utilizing an implant studied by manometry in a human eye” Exp Eye Res 1967; 6:75-78.
Gills JP “Cyclodialysis implants” South Med J. 1967 60(7):692-5.
Gills, “Cyclodialysis Implants in Human Eyes” Am J Ophth 61:1966,841-846.
Goldberg “Management of Uncontrolled Glaucoma With the Molteno System” Australian and New Zealand Journal of Ophthalmology 1987; 15: 97-107.
Gordon MO, Kass. MA, for the Ocular Hypertension Treatment Study Group. The Ocular Hypertension Treatment Study. Design and baseline description of the participants. Arch Ophthalmol 1999:573-83.
Grant, W.M. , MD, Further Studies on Facility of Flow Through the Trabecular Meshwork, A.M.A. Archives of Ophthalmololgy, Oct. 1958, vol. 60, pp. 523-533.
Gross et al. “Surgical therapy of chronic glaucoma in aphakia and pseudophakia” Ophthalmology, 95:1195-201 (1988).
Harper SL, Foster CS. Intraocular lens explantation in uveitis. Int Ophthalmol Clin. 2000 Winter; 40(1):107-16.
Harrington “Cataract and Glaucoma. Management of the coexistent conditions and a description of a new operation combining lens extraction with reverse cyclodialysis.” Am J Ophthalmol. May 1966;61(5 Pt 2):1134-40.
Heijl A, Leske MC, Bengtsson B, et al for the Early Manifest Glaucoma Trial Group. Reduction of intraocular pressure and glaucoma progression. Results from the Early Manifest Glaucoma Trial. Arch Ophthalmol 2002;120:1268-79.
Heine I. “Cyclodialysis, a new glaucoma operation” [German] Dtsch Med Wochenschr, 31:824-826 (1905).
Hildebrand et al. “Efficacy of anterior chamber decompression in controlling early intraocular pressure spikes after uneventful phacoemulsification” J. Catact Refract Surg., 29:1087-92 (2003).
Hoskins, et al., “Aqueous Humor Outflow”, Becker-Shaffer's Diagnosis and Therapy of the Glaucomas, 6th Edition, Chapter 4, pp. 41-66, 1989.
Howorth D J “Feasibility study for a micromachined glaucoma drainage device” Cranfield University School of industrial and manufacturing science MSc Thesis Academic Year 2001-2002 Sep. 13, 2002.
Hylton et al. “Update on prostaglandin analogs” Curr Opin Ophthalmol, 14:65-9 (2003).
Javitt JC, Chiang YP. Preparing for managed competition. Utilization of ambulatory eye care visits to ophthalmologists. Arch Ophthalmol 1993;111:1034-5.
Jay JL, Allan D. The benefit of early trabeculectomy versus conventional management in primary open-angle glaucoma relative to severity of disease. Eye 1989; 3:528-35.
Jordan J. “A Novel Approach to Suprachoroidal Drainage for the Surgical Treatment of Intractable Glaucoma” J. Glaucoma 15:200-205 (2006).
Jordan JF, Dietlein TS, Dinslage S, Luke C, Konen W, Krieglstein GK. Cyclodialysis ab inferno as a surgical approach to intractable glaucoma. Graefes Arch Clin Exp Ophthalmol. Aug. 2007;245(8):1071-6.
Karlen et al. “Deep sclerectomy with collagen implant: medium term results” Br. J. Ophthalmol, Jan. 1999, 83(1):6-11.
Kass MA, Heuer DK, Higginbotham EJ, et al for the Ocular Hypertension Treatment Study Group. The Ocular HypertensionTreatment Study. A randomized trial determines that topical ocular hypotensive medication delays or prevents the onset of primary open-angle glaucoma. Arch Ophthalmol 2002;120:701-13.
Klemm et al. “Die Ultraschallbiomikroskopie als Kriterium der Funktionsprüfung des suprachorioidalen Spaltes nach kammerwinkelchirurgischen Eingriffen” (Ultrasound Biomicroscopic Imaging for Assessment of the Suprachoroidal Cleft after Angle Surgery) “Klinische Monatsblätter für Augenheilkunde 1997; 210: 74-77 [Article in German with English summary included]”.
Klemm et al. “Experimental use of space-retaining substances with extended duration: functional and morphological results” Graefes Arch Clin Exp Ophthalmol Sep. 1995; 233(9):592-7.
Kozlov et al. “Nonpenetrating deep sclerectomy with collagen” Eye microsurgery 3:44-46 (1990) [Russian with English translation].
Krejci “Cyclodialysis with hydroxymethyl methacrylate capillary strip (HCS). Animal experiments with a new approach in glaucoma drainage surgery” Ophthalmologica 1972; 164(2):113-21.
Krejci L. “Microdrainage of anterior chamber of eye glaucoma operation using hydron capillary drain. ” Acta Univ Carol Med Monogr. 1974;(61):1-90.
Kupfer “Studies on intraocular pressure. I. A technique for polyethylene tube implantation into the anterior chamber of the rabbit.” Arch Ophthalmol. Apr. 1961;65:565-70.
La Rocca “Gonioplasty in Glaucoma*A Preliminary Report” Br J Ophth 46:1962, 404-415.
Law et al., “Retinal Complications After Aqueous Shunt Surgical Procedures for Glaucoma” Arch Ophthal.; Dec. 1996; vol. 114:1473-1480.
Lee et al. “Aqueous-venous shunt and intraocular pressure. Preliminary report of animal studies.” Investigative Ophthalmology. vol. 5 No. 1: 59-64. Feb. 1966.
Lee et al. “Magnetic resonance imaging of the aqueous flow in eyes implanted with the trabeculo-suprachoroidal glaucoma seton” Invest. Ophthalmol. Vis. Sci. 33:948 (1992).
Lee KY. Trabeculo-suprachoroidal shunt for treating recalcitrant and secondary glaucoma. Presented at the American Academy of Ophthalmology Annual Meeting, Anaheim, CA, 1991.
Leske MC, Heijl A, Hussein M, et al for the Early Manifest Glaucoma Trial Group. Factors for glaucoma progression and the effect of treatment. The Early Manifest Glaucoma Trial. Arch Ophthalmol Jan. 2003;121:48-56.
Lichter PR, Musch DC, Gillespie BW, et al and the CIGTS Study Group. Interim clinical outcomes in the Collaborative Initial Glaucoma Treatment Study comparing initial treatment randomized to medications or surgery. Ophthalmology 2001;108:1943-53.
Losche W. “Proposals for improvement of cyclodialysis” Klin Monatsblatter Augenheilkd Augenarztl Fortbild 121(6):715-6 (1952) [German].
Marx et al., “Use of the Ganciclovir Implant in the Treatment of Recurrent Cytomegalovirus Retinitis” Arch Ophthal.; Jul. 1996; vol. 114:815-820.
McPherson “Combined Trabeculotomy and Cataract Extraction as a Single Operation” Tr. Am. Ophth. Soc., vol. LXXIV, 1976; 251-260.
Migdal C, Gregory W, Hitchings R. Long term functional outcome after early surgery compared with laser and medicine in open-angle glaucoma. Ophthalmology 1994;101:1651-7.
Miglior S, Pfeiffer N, Zeyen T et al for the European Glaucoma Prevention Study Group. Results of the European Glaucoma Prevention Study. Ophthalmology 2005;112:366-75.
Miglior S, Zeyen T, Pfeiffer N, et al for the European Glaucoma Prevention Study Group. The European Glaucoma Prevention Study design and baseline description of the participants. Ophthalmology 2002;109:1612-21.
Miki, MD et al., “Intraocular Cannula for Continuous, Chronic Drug Delivery-Histopathic Observations and Function” Arch Ophthal.; May 1985; vol. 103:712-717.
Molteno et al. “Long tube implants in the management of glaucoma.” South African Medical Journal, Jun. 26, 1976;50(27):1062-6.
Molteno et al. “The Vicryl tie technique for inserting a draining implant in the treatment of secondary glaucoma. ” Australian and New Zealand Journal of Ophthalmology 1986; 14: 343-354.
Moses RA “Detachment of ciliary body-anatomical and physical considerations” Investigative Ophthalmology & Visual Science, Assoc. for Research in Vision and Ophthalmology, US, vol. 4, No. 5, Oct. 1, 1965.
Nesterov AP et al. “Surgical stimulation of the uveoscleral outflow. Experimental studies on enucleated human eyes” Acta Opthalmol (Copenh) June; 57(3):409-17 (1979).
Nguyen et al., “Complications of Baerveldt Glaucoma Drainage Implants” Arch Ophthal.; May 1998; vol. 116:571-575.
Noecker RJ. Clinical Evaluation of a Novel Gold Micro-Shunt for Reduction of 10 P in Refractory Glaucomas. American Glaucoma Society Annual Meeting, San Francisco, CA, 2007.http://www.glaucomaweb.org/associations/5224/files/AGS%20AM07%20Prgrm%20FINAL.pdf. Accessed Nov. 1, 2008).
O'Brien et al. “Cyclodialysis” Arch Ophthal. 1949;42(5):606-619.
Odrich. “The New Technique During Complex Tube-Shunt Implantation”. J. Glaucoma. vol. 9 No. 3 (2000):278-279.
Olsen, Timothy W., et al., Cannulation of the Suprachoroidal Space: A Novel Drug Delivery Methodology to the Posterior Segment, American Journal of Ophthalmology, vol. 142, No. 5, Nov. 2006, pp. 777-787.e2.
Ozdamar et al. “Suprachoroidal seton implantation in refractory glaucoma: a novel surgical technique” J. Glaucoma Aug. 2003; 12(4):354-9.
Pinnas G. et al. “Cyclodialysis with teflon tube implants” Am J. Ophthalmol Nov. 1969; 68(5):879-883.
Portney GL, “Silicone elastomer implantation cyclodialysis.” Arch Ophthalmol 1973; 89: 10-12.
Primary Open Angle Glaucoma. Preferred Practice Patterns, American Academy of Ophthalmology.http://one.aao.org/CE/PracticeGuidelines/PPP—Content.aspx?cid=a5a59e02-450b-4d50-8091-b2dd2lefl ff2#references (Accessed Nov. 1, 2008).
Pruett et al., “The Fishmouth Phenomenon-II. Wedge Scleral Buckling” Arch Ophthal.; Oct. 1977; vol. 95:1782-1787.
Qadeer “Acrylic Gonio-Subconjunctival Plates in Glaucoma Surgery” Br J Ophthalmol. Jun. 1954; 38(6): 353-356.
Quigley HA, Vitale S. Models of open-angle glaucoma prevalence and incidence in the United States. Invest Ophthalmol Vis Sci 1997; 38:83-91.
Richards et al. “Artificial Drainage Tubes for Glaucoma” Am J Ophth 60:1965,405-408.
Ritch, et al., “Uveoscleral Outflow”, The Glaucomas. St. Louis: Mosby, 1996; pp. 337-343.
Rohen, Johannes W., Anatomy of the Aqueous Outflow Channels, Glaucoma, vol. 1, Chapter 14, pp. 277-296, Edited by J.E. Cairns, Grune & Stratton, Harcourt Brace Jovanovich Publishers, 1986.
Rosenberg, et al. “Implants in glaucoma surgery” Chapter 88, The Glaucomas, Ritch et al. Eds. 2nd Ed. Mosby St. Louis 1996; p. 1783-1807.
Row H. “Operation to control glaucoma: preliminary report” Arch. Ophthal 12:325 (1934).
Rowan, Patrick J., MD, Combined Cyclodialysis and Cataract Surgery, Ophthalmic Surgery and Lasers, Dec. 1998, vol. 29, No. 12, pp. 962-968 (9 pages).
Sampimon “A New Approach to Filtering Glaucoma Surgery” Ophthalmologica (Basel) 151: 1966, 637-644.
Schappert S. Office visits for glaucoma: United States, 1991-92. Advance data from vital and health statistics. vol. 262. Hyattsville, MD: National Center for Health Statistics, 1995.
Shaffer RN, Weiss DI. Concerning cyclodialysis and hypotony. Arch Ophthalmol 68: 25, 1962.
SOLX Clinical Literature Handout; Industry Show Feb. 2006; “The SOLX Gold Micro-shunt (GMS) treatment”.
Sommer A, Tielsch JM, Katz J, et al. Racial differences in the cause-specific prevalence of blindness in east Baltimore. N Engl J Med 1991;325:1412-7.
Sourdille et al. “Reticulated hyaluronic acid implant in non-perforating trabecular surgery.” J Cataract Refract Surg 25: 332-339. (1999).
Spiegel et al. “Schlemm's Canal Implant: A New Method to Lower Intraocular Pressure in Patients With POAG?” Ophthalmic Surgery and Lasers. vol. 30, No. 6: 492-494. Jun. 1999.
Srinivasan et al. “Microbial contamination of the anterior chamber during phacoemulsification” J. Cataract Refract Surg. 28:2173-6 (2002).
Suguro K, Toris CB, Pederson JE. Uveoscleral outflow following cyclodialysis in the monkey eye using a fluorescent tracer. Invest Ophthalmol Vis Sci 1985: 26, 810.
The Advanced Glaucoma Intervention Study (AGIS): 7. The relationship between control of intraocular pressure and visual field detorioration. The AGIS Investigators. Am J Ophthalmol 2000;130:429-40.
The Advanced Glaucoma Intervention Study (AGIS); 13. Comparison of treatment outcomes within race: 10-year results. Ophthalmology 2004;111:651-64.
The Glaucoma Laser Trial (GLT) and Glaucoma Laser Trial Follow-up Study: 7. Results. Am J Ophthahnol 1995;120:718-31.
The Glaucoma Laser Trial (GLT). 2. Results of argon laser trabeculoplasty versus topical medicines. The Glaucoma Laser Trial Research Group. Ophthalmology 1990;97:1403-13.
Thiagalingam S, Tarongoy P, Hamrah P, Lobo AM, Nagao K, Barsam C, Bellows R, Pineda R. Complications of cosmetic iris implants. J Cataract Refract Surg. Jul. 2008;34(7):1222-4.
Tielsch JM, Sommer A, Katz J, et al. Racial variations in the prevalence of primary open-angle glaucoma. The Baltimore Eye Survey. JAMA 1991;266:369-74.
Toris CB. Extravascular albumin concentration of the uvea. Invest Ophthalmol Vis Sci 1990; 31:43.
Toris et al. “Aqueous humor dynamics in the aging human eye” Am J. Ophthalmol., 127:407-12 (1999).
Toris et al. “Effect of intraocular pressure on uveoscleral outflow following cyclodialysis in the monkey eye.” Investigative Ophthalmology & Visual Science. 26 (1985) 1745-1749.
Transcend Medical Inc. v. Glaukos Corporation, Transcend Medical, Inc.'s Disclosures Pursuant to Default Discovery Rule 4 (d) (United States District Court for the District of Delaware, dated Dec. 6, 2013; case No. C.A. No. 13-830 (MSG) and Certificate of Service, dated Dec. 9, 2013.
Trigler L, Proia AD, Freedman SF. Fibrovascular ingrowth as a cause of Ahmed glaucoma valve failure in children. Am J Ophthalmol. Feb. 2006;141(2):388-9.
Troncoso Manuel U., “Cyclodialysis with insertion of metal implant in treatment of glaucoma, a Preliminary Report” Arch. Ophthal. 23:270 (1940).
Troncoso, Manuel U., Tantalum implants for inducing hypotny, Am Journal of Ophthalmology, vol. 32(4):499-508 (1949).
Van der Veen et al. “The gonioseton, a surgical treatment for chronic glaucoma”. Documenta Ophthalmologica; vol. 75, Nos. 3-4, 365-375. (1990).
Vossmerbaeumer U, Ditzen K, Jonas JB. Removal of an intracorneal hydrogel implant for hyperopia after Lasik. J Refract Surg. Jan. 2007;23(1):102-4.
Wagner, Justin A., et al., Characterization of Uveoscleral Outflow in Enucleated Porcine Eyes Perfused under Constant Pressure, Invest Ophthalmol Vis Sci., Published in edited form in Sep. 2004, vol. 45, Issue 9, pp. 3203-3206.
Wamsley S, Moster MR, Rai S, Alvim HS, Fontanarosa J. Results of the use of the Ex-Press miniature glaucoma implant in technically challenging, advanced glaucoma cases: a clinical pilot study. Am J Ophthalmol. Dec. 2004; 138(6): 1049-51.
Yablonski, “Some thoughts on the pressure dependence of uveoscleral flow” Journal of Glaucoma, 12(1):90-92 (2003).
Yablonski, “Trabeculectomy with Internal Tube Shunt: a novel glaucoma surgery” J. Glaucoma 14:91-97 (2005).
Yoo C, Kwon SW, Kim YY. Pericardium plug in the repair of the corneoscleral fistula after ahmed glaucoma valve explantation. Korean J Ophthalmol. Dec. 2008;22(4):268-71.
Zhou et al. “A trabecular bypass flow hypothesis” J Glaucoma. 14(1):74-83 (2005).
In the Commonwealth of Australia—In the Matter of Australian Patent Application No. 2006336598 in the name of Transcend Medical, Inc. (“Applicant”) and Opposition thereto by Glaukos Corporation (“Opponent”)—Declaration of Dr. Colin Clement in support of Opponent's opposition. (Sep. 9, 2014).
In the Commonwealth of Australia—in the Matter of Australian Patent Application No. 2006336598 in the name of Transcend Medical, Inc. (“Applicant”) and Opposition thereto by Glaukos Corporation (“Opponent”)—Declaration of Dr. Ilesh Patel in support of Opponent's opposition. (Sep. 9, 2014).
In the Commonwealth of Australia—in the Matter of Australian Patent Application No. 2006336598 in the name of Transcend Medical, Inc. (“Applicant”) and Opposition thereto by Glaukos Corporation (“Opponent”)—Declaration of Mr. Craig Andrews in support of Opponent's opposition. (Sep. 9, 2014).
In the Commonwealth of Australia—in the Matter of Australian Patent Application No. 2006336598 in the name of Transcend Medical, Inc. (“Applicant”) and Opposition thereto by Glaukos Corporation (“Opponent”)—Opponent's amended Statement of Grounds and Particulars of Opposition. (Sep. 10, 2014).
In the Commonwealth of Australia—in the Matter of Australian Patent Application No. 2006336598 in the name of Transcend Medical, Inc. (“Applicant”) and Opposition thereto by Glaukos Corporation (“Opponent”), Commonwealth of Australia—Opponent's Statement of Grounds and Particulars of Opposition. (Apr. 10, 2014).
Schocket, Stanley S. “Investigations of the Reasons for Success and Failure in the Anterior Shunt-To-The-Encircling-Band Procedure in the Treatment of Refractory Glaucoma.” Tr. Am. Ophth. Soc.vol. LXXXIX. (1986):743-798.
Related Publications (1)
Number Date Country
20130281908 A1 Oct 2013 US
Provisional Applications (1)
Number Date Country
61637789 Apr 2012 US