Patent Description:
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. <CIT> describes an ocular implant and delivery system having a channel tool adapted to extend through at least a portion of Schlemm's Canal and an ocular implant adapted to be disposed into Schlemm's Canal. <CIT> relates to devices that are implanted within the eye, particularly to systems, devices and methods for delivering ocular implants into the eye. Figure <NUM> shows an ocular implant being delivered into Schlemm's canal using a delivery system cannula.

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 inferno procedure.

The invention is defined by claim <NUM> with preferable embodiments in the dependent claims.

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 includes 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 includes a sheath positioned axially over a guidewire. The guidewire is configured to be inserted longitudinally through one of the one or more internal lumens of the ocular implant. The guidewire includes at least one retention feature along a length of the guidewire which assists in retaining the ocular implant along the length of the guidewire. The at least one retention feature includes at least one S-shaped curve. The delivery device further includes an actuator coupled to a mechanism that releases the ocular implant from the delivery portion upon actuation of the actuator. The mechanism is configured to retract the guidewire upon actuation of the actuator and release the ocular implant.

Also described herein but not claimed 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.

These and other aspects will now be described in detail with reference to the following drawings.

<FIG> 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 <NUM> is positioned inside the eye such that a proximal end <NUM> is located in the anterior chamber <NUM> and a distal end <NUM> 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> 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 <NUM> provides a fluid pathway between the anterior chamber <NUM> into the supraciliary space and toward the suprachoroidal space. The implant <NUM> has a distal end120 that may be positioned in the supraciliary space or the suprachoroidal space. The implant <NUM> 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 <NUM> of the implant <NUM> is not necessarily positioned between the choroid and the sclera.

In an embodiment, the implant <NUM> is an elongate element having one or more internal lumens through which aqueous humor can flow from the anterior chamber <NUM> into the supraciliary space. The implant <NUM> can have a substantially uniform internal diameter along its entire length, although the shape of the implant <NUM> can vary along its length (either before or after insertion of the implant), as described below. Moreover, the implant <NUM> 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: <CIT>and <CIT>.

<FIG> 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 <NUM> serves as a passageway for the flow of aqueous humor through the implant <NUM> directly from the anterior chamber toward or into the supraciliary or suprachoroidal space. In addition, the internal lumen of the implant <NUM> can be used as an access location to mount the implant <NUM> 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> shows an embodiment of a delivery system <NUM> that can be used to deliver the implant <NUM> into the eye. In some embodiments, the implant <NUM> 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 <NUM> are exemplary and that variations in the structure, shape and actuation of the delivery system <NUM> are possible. The delivery system <NUM> can include a proximal handle component <NUM> and a distal delivery component <NUM>. The proximal handle component <NUM> can include an actuator <NUM>, such as a button, to control the release of an implant from the delivery component <NUM> into a target location in the eye. The actuator <NUM> can vary in structure and is not limited to a button.

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

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

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

In some embodiments, the actuator <NUM> can be a push-button that is coupled to a spring-activated mechanism. Upon applying a force onto the actuator <NUM>, the spring mechanism can retract the guidewire <NUM> toward and/or into the sheath <NUM> which can release the implant <NUM> from the guidewire <NUM>. The mechanism by which the guidewire <NUM> can be withdrawn into the sheath <NUM> 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> shows an embodiment of a portion of the delivery system <NUM> in cross-section with the implant <NUM> loaded onto the guidewire <NUM>. The delivery system <NUM> can include a front spring <NUM> which can assist in positioning the guidewire <NUM>. For example, the front spring <NUM> can be compressed or charged which can allow the guidewire <NUM> to be positioned in an extended state relative to the handle <NUM>. When the guidewire <NUM> is in an extended state, the guidewire <NUM> can be loaded with the implant <NUM>, as shown in <FIG>.

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

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

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

In some embodiments, for example, the front spring <NUM> can provide approximately <NUM> to <NUM> N (<NUM> to <NUM> lbf) at the compressed or charged configuration which can allow the guidewire <NUM> to withdraw from the implant <NUM>, including when the implant <NUM> is positioned at an approximate <NUM> degree angle relative to the stopper tube <NUM>. However, the front spring <NUM> can provide any of a variety of spring force which allows the guidewire <NUM> to release the implant <NUM> positioned at a variety of angles relative to at least the stopper tube <NUM>.

In some embodiments, the front spring <NUM> can create approximately <NUM> to <NUM> N (<NUM> to <NUM> lbf). For example, a greater spring force of the front spring <NUM> can allow the guidewire <NUM> to retract in a variety of conditions. In addition, a lower force of the front spring, such as <NUM> to <NUM> N (<NUM> to <NUM> lbf), may reduce the speed of the retraction and reduce the force required to reload the system. Any of a variety of front springs <NUM> can be implemented in the delivery system <NUM>.

A dampening element, such as grease <NUM>, may be placed between the piston <NUM> and inside wall of the handle <NUM> which can assist in providing a slower retraction of the guidewire <NUM>. A slower retraction of the guidewire <NUM> can prevent or lessen any jerking motion of the delivery system <NUM> in the user's hands, including at the end of the piston <NUM> travel. This dampening grease <NUM> can be a silicone grease such that grease is unaffected by production level e-beam sterilization dose of <NUM> -<NUM> kGy. In addition, other dampening elements aside from grease <NUM> 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 <NUM> 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 <NUM> (<NUM>" 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 <NUM> retraction which also allows the user to maintain the distal end of the delivery device <NUM> 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 <NUM> during the guidewire retention.

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

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

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

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

In some embodiments, the guidewire <NUM> can have one or more cut patters along a length of the guidewire <NUM> which can allow the guidewire <NUM> to be more flexible than the material comprising the guidewire <NUM> can allow. For example, the distal end or tip of the guidewire <NUM> can include a spiral cut pattern which allows the tip of the guidewire <NUM> to deflect or bend in one or more of a variety of directions relative to a longitudinal axis of the guidewire <NUM>. Furthermore, the spiral cut pattern can allow the distal end or tip of the guidewire <NUM> 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 <NUM> to be released to an area surrounding the guidewire, including either the implant or the eye.

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

According to the invention, the retention feature includes an S-shaped curve along a length of the guidewire <NUM> which can have one or more rounded curved features <NUM>, including bends or peaks, as shown in <FIG>. Furthermore, each retention feature, such as curved feature <NUM>, can form a point of contact between the inner lumen of the implant <NUM> and the guidewire <NUM>. The curved features <NUM> of the guidewire S-curve can also reduce the risk of damaging the inner lumen of the implant <NUM> as the guidewire <NUM> is released from the implant <NUM>. In addition, the retention features can provide a gentle interaction and retention between the guidewire <NUM> and the implant <NUM>, including during removal of the guidewire <NUM> from the implant <NUM>. Alternatively, the guidewire <NUM> 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 <NUM>.

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 <NUM> of the implant <NUM>. For example, larger peak-to-peak distances between the two or more curved features <NUM> 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 <NUM>, such as due to the guidewire <NUM> scraping away material along the inner lumen during removal. For example, the peak-to-peak distance may be in the range of approximately <NUM> (<NUM>") to approximately <NUM> (<NUM>"), or in the range of approximately <NUM> (<NUM>") to approximately <NUM> (<NUM>"). In addition, at least one retention force acting upon the implant <NUM>, such as a polyimide implant, by the guidewire <NUM> of approximately <NUM> - <NUM> N (. <NUM> lbf) can be sufficient to retain the implant <NUM> along the guidewire <NUM> during manipulation of the implant <NUM> prior to implantation into the target location.

In alternate embodiments, the material of the guidewire <NUM> 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 <NUM> can have a radius of curvature or arc which is less than <NUM> (<NUM>"), such as in order to provide a small curvature of the implant <NUM> during insertion. This configuration can be advantageous when access between the incision and the target location requires the implant <NUM> to be introduced into the target location by way of a small radius, such as less than <NUM> (<NUM>").

Alternatively, the radius of curvature or arc of the guidewire <NUM> can be larger than <NUM> (<NUM>"). Any of a variety of radius of curvature or arcs of the guidewire <NUM> can be implemented into any of the delivery systems <NUM> in order to best accommodate insertion of the implant <NUM> into the designated target location. For example, the radius of curvature or arc of the guidewire <NUM> may be such that it can allow the implant <NUM> to bend against the scleral wall during insertion into the supraciliary space. In addition, the retention features of the guidewire <NUM> can vary and can include one or more of a variety of shapes and sizes along a length of the guidewire <NUM>. 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 <NUM>. For example, at least two, including more than five or more than ten retention features can be positioned along a length of the guidewire <NUM>. In addition, each retention feature can provide the same or a variety of different amounts of retention forces for securing the implant <NUM> in a position along the guidewire <NUM>. In some embodiments, the peak-to-peak distance between the retention features can be larger than the inner diameter of the implant <NUM> and can be a dimensioned larger than <NUM> (. <NUM>") such that it does not damage the implant <NUM>.

In some embodiments of the delivery system <NUM>, not falling under the scope of the claims, instead of using the guidewire <NUM> to provide retention of the implant <NUM>, an additional feature of the delivery system <NUM> or device can be used in order to provide the necessary retention of the implant <NUM> onto the guidewire <NUM>. This may include, for example, a Pebax material which can be coupled onto a part of the guidewire <NUM> in order to create at least a width along the guidewire <NUM> that is larger than the inner diameter of the implant <NUM>. For example, the Pebax material can be crimped to the guidewire and can retain the implant <NUM> relative to the guidewire <NUM> until the implant <NUM> is released from the delivery system <NUM>, such as after actuation of the actuator <NUM>.

As shown in <FIG>, the delivery system <NUM> 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 <NUM>. 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 <NUM> having at least one inner lumen. The elongated tube <NUM> can extend outward from the handle <NUM>. In addition, the elongated tube <NUM> can extend through the handle <NUM>. Additionally, the elongated tube <NUM> can have an internal lumen which communicates with an internal lumen of the guidewire <NUM>.

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

In some embodiments, the elongated tube <NUM> 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 <NUM> which can be delivered to a variety of places either within at least one of the delivery system <NUM>, the implant <NUM> or the eye. For example, some of the fluid provided by the fluid source can be passed through the elongated tube <NUM> and exit the guidewire <NUM> via the slots <NUM> for delivery into the eye.

The size of the at least one inner lumens of the elongated tube <NUM> and guidewire <NUM> may vary. In an embodiment, the inner lumen of either the elongated tube <NUM> or guidewire <NUM> can be within a range of approximately <NUM> (. <NUM>") to approximately <NUM> (. <NUM>") in diameter, or approximately <NUM> (. <NUM>") to approximately <NUM> (. <NUM>") 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 <NUM> or the guidewire <NUM>.

In some embodiments, the distal slots <NUM> of the guidewire <NUM> can allow fluid from at least the fluid source to be delivered to a distal end of the implant <NUM>, including during or after implantation of the implant <NUM>. 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 <NUM>. The size and location of the slots <NUM> can be sized, shaped and positioned along the guidewire <NUM> in order to create a variety of fluid delivery effects. For example, at least two slots <NUM> can be configured symmetrically relative to the distal end of the guidewire <NUM> 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 <NUM>/sec to <NUM>/sec, or approximately <NUM>/sec to <NUM>/sec. In addition, the burst pressure of the delivery system <NUM>, including the fluid delivery features, can be large enough to withstand the pressure of injecting a fluid through the lumens of the delivery system <NUM> and implants <NUM>.

In some embodiments, the burst pressure of the delivery system <NUM> can be larger than the pressure required for the fluid to flow from the fluid source through at least the delivery system <NUM>. For example, the burst pressure can be approximately <NUM> kPa (<NUM> psi) to approximately <NUM> kPa (<NUM> psi), or approximately <NUM> kPa (<NUM> psi) to approximately <NUM> kPa (<NUM> psi). In addition, the burst pressure required for viscoelastic flow of Healon <NUM> can be approximately <NUM> kPa (<NUM> psi) to approximately <NUM> kPa (<NUM> psi), or approximately <NUM> kPa (<NUM> psi) to approximately <NUM> kPa (<NUM> psi).

In some embodiments, fluid from the fluid source can be delivered to one or more sections along the axial length of the implant <NUM>. For example, one or more holes along the length of the implant <NUM> (as shown in <FIG>) can be configured to be sufficiently large such that a fluid may be delivered from the guidewire <NUM>. For example, one or more slits <NUM> positioned along the length of the guidewire <NUM>, such as below a loaded implant <NUM>, can allow fluid to travel through the at least one hole along the length of the implant <NUM> 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 <NUM> (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 <NUM> can assist in creating additional space surrounding the implant <NUM> which can improve tenting.

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

The system may also be used for the ab-interno delivery of fluids to other locations in the eye. <FIG>, for example, shows the guidewire <NUM> 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 <NUM> 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 <NUM> 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 <NUM> may be inserted through the sclera with the tip of the guidewire <NUM> 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 <NUM> 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 <NUM> in the eye can include loading one or more implants <NUM> on a delivery system <NUM> and implanting the implants <NUM> by way of an ab interno procedure. The implant <NUM> can be implanted such that it can provide fluid communication between the anterior chamber and the supraciliary or suprachoroidal space. The implant <NUM> 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 <NUM> can be positioned on the delivery system <NUM> such that the distal tip of the guidewire <NUM>, the implant <NUM> and sheath <NUM> 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 <NUM> of the limbus in the clear cornea. The guidewire <NUM> 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 <NUM>. In an embodiment, the incision can be approximately <NUM> in size. In another embodiment, the incision can be no greater than approximately <NUM> in size. In another embodiment, the incision is no greater than approximately <NUM> and can be greater than approximately <NUM>.

After insertion through the incision, the guidewire <NUM> can be advanced into the anterior chamber along a pathway that enables the implant <NUM> to be delivered to a position such that the implant <NUM> provides a flow passageway from the anterior chamber toward the suprachoroidal space. The guidewire <NUM> can be advanced further into the eye such that the blunt distal tip of the guidewire <NUM> and/or the implant <NUM> 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 <NUM> can approach the iris root from the same side of the anterior chamber as the deployment location such that the guidewire <NUM> does not have to be advanced across the iris. Alternately, the guidewire <NUM> can approach the location from across the anterior chamber such that the guidewire <NUM> is advanced across the iris and/or the anterior chamber toward the opposite iris root. The guidewire <NUM> can approach the eye and the iris root along a variety of pathways. For example, the guidewire <NUM> 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 <NUM> 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> 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> shows the implant <NUM> loaded onto a guidewire <NUM> and approaching the supraciliary space or suprachoroidal space from the anterior chamber AC. The implant <NUM> mounted on the guidewire <NUM> can move along a pathway such that the dissection entry point of the distal tip of the guidewire <NUM> 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 <NUM> of the delivery system <NUM> in order to obtain a proper approach trajectory for the distal tip of the guidewire <NUM>, as described in further detail below.

The guidewire <NUM> with the implant <NUM> 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 <NUM> and implant <NUM> 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 <NUM> can then be advanced further such that the guidewire <NUM> and implant <NUM> 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 <NUM> in length. Once the distal tip of the guidewire <NUM> penetrates and is urged past this fibrous attachment region, the guidewire <NUM> 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 <NUM> 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 <NUM> and implant <NUM> can follow the curve of the inner scleral wall such that the implant <NUM> mounted on the guidewire <NUM> 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 <NUM> and implant <NUM> after either the guidewire <NUM> or implant <NUM> penetrates the iris root or the iris root portion of the ciliary body. In an embodiment, the implant <NUM> 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 <NUM> does not reach and cannot contact the choroid. In another embodiment, the implant <NUM> 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 <NUM> to approximately <NUM> of the implant (along the length) remains in the anterior chamber AC. The implant <NUM> can be positioned so that a portion of the implant <NUM> is sitting on top of the ciliary body CB. The ciliary body CB may act as a platform off of which the implant <NUM> can cantilever towards or into the suprachoroidal space SChS although the implant may not actually enter the suprachoroidal space. The implant <NUM> can lift or "tent" the sclera S outward such that a tented chamber is formed around the distal end of the implant <NUM>. 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 <NUM> does not extend far enough to reach the choroid. In another embodiment, the distal end of the implant <NUM> reaches the choroid and can contact the choroid.

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

The implant <NUM> can include one or more structural features near its proximal region that aid to anchor or retain the implant <NUM> 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 <NUM> in place and prevent the implant <NUM> from moving further into the suprachoroidal space SchS.

The delivery system <NUM> can be used in combination with any number of devices and systems in order to complete a variety of procedures. For example, the delivery system <NUM> can be used with a direct visualization (DV) system which is configured and adapted to measure one or more anatomical features of the eye, including the iridocorneal angle of the eye. The DV system can, for example, provide a user with measurements which can allow the user to determine an appropriately sized implant for implantation into the eye. In addition, the measurements can assist the user in properly positioning and implanting the implant into the eye, including the implant <NUM> described above. More specifically, the delivery system <NUM> can utilize the one or more measurements taken by the DV system in order to assist the delivery system <NUM> in properly positioning and implanting an appropriately sized implant.

<FIG> shows a perspective view of an embodiment of a DV system <NUM> which can be comprised of a hand-held tool having a DV wire <NUM> that is movably coupled to an elongated handle <NUM>. At least a portion of the DV wire <NUM> can be slidably and axially-positioned in a stopper tube <NUM> affixed to a distal end <NUM> of the handle <NUM>. Both the stopper tube <NUM> and the DV wire <NUM> can extend outward from the distal end <NUM> of the handle <NUM>. The handle <NUM> can be sized and shaped to be held in a single hand of a user. In addition, the handle <NUM> can be configured such that the DV system <NUM> can be operated single handedly. Furthermore, the handle <NUM> can have one or more gripping features <NUM>, such as ridges and cutouts, for improved ergonomics and ease of holding.

The DV wire <NUM> can be coupled to a spring <NUM> inside the handle <NUM> which can allow the DV wire <NUM> to move inward and outward along a longitudinal axis of the DV system <NUM> and relative to the handle <NUM> and stopper tube <NUM>. The spring <NUM> can provide a spring force that can assist in allowing the DV wire <NUM> to retract proximally into the handle <NUM> upon an applied force against the distal end of the DV wire <NUM>. The spring constant of the spring <NUM> can be relatively low such that the DV wire <NUM> moves relatively easily when a force is applied. In one aspect, the spring constant can be sufficiently low such that the DV wire <NUM> will yield and ocular tissue is not damaged when the distal tip of the DV wire <NUM> is pressed against ocular tissue. In addition, a handle plug <NUM> (as shown in <FIG>) inside the handle <NUM> can provide a hard stop for the DV wire <NUM> which can limit the distance that the DV wire <NUM> can retract into the stopper tube <NUM> and handle <NUM>.

In some embodiments the stopper tube <NUM> can extend straight out of and along the same longitudinal axis as the handle <NUM>. However, in some embodiments the stopper tube <NUM> can be curved or extend in a variety of other configurations. For example, the stopper tube <NUM> may be curved which can provide easier access to particular anatomical parts of the eye, such as the base of the iridocorneal angle. The distal end of the stopper tube <NUM> can have rounded edges which can assist in preventing damage to ocular tissue during use. In addition, the stopper tube <NUM> can be manufactured out of a variety of materials, such as stainless steel, titanium, plastics, or other equivalent materials, including any number of medical grade materials.

<FIG> shows an enlarged view of the DV wire <NUM> and distal region of the stopper tube <NUM>. The DV wire <NUM> can have a distal contact tip <NUM> that can be configured to be pressed against ocular tissue. The contact tip <NUM> may be rounded or blunt to eliminate or reduce tissue damage by the contact tip <NUM> when pressed against ocular tissue. In addition, one or more indicators or marks <NUM> can be positioned along a length of the DV wire <NUM>. In some embodiments, one or more indicators <NUM> can be positioned along a length of either the DV wire <NUM> or stopper tube <NUM>. The indicators <NUM> can assist a user in acquiring measurements of one or more anatomical features of the eye. For example, the distal end of the DV wire <NUM> can be placed against the base of the angle of the eye such that the user can then determine the depth of the angle.

The indicators <NUM> can be arranged along the DV wire <NUM> such that they correspond to a standard form of measurement, i.e., millimeters, fractions of an inch, etc. In such an embodiment, a user can use the DV wire <NUM> to make specific measurements, including measurements of particular anatomical features of the eye. In some embodiments, the indicators <NUM> do not correlate with a standard form of measurement and are simply reference points along the DV wire <NUM>. In either embodiment, a user can position the DV wire <NUM> in the eye and use any of the indicators <NUM> as reference points relative to various anatomical features in the eye. As will be discussed in greater detail below, the referenced indicators <NUM> can assist the user in subsequent procedures, including determining an appropriately sized implant for the eye as well as assisting in correctly inserting the implant into the eye, including with the delivery system <NUM>.

The DV wire <NUM> can be manufactured out of a variety of materials, such as stainless steel, titanium, plastics, or other equivalent materials, including any number of medical grade materials. In addition, the DV wire <NUM> can be at least partially tubular or hollow in order to allow one or more components, such as the measuring features discussed below, to be contained within the DV wire <NUM>, including within the contact tip <NUM>.

The contact tip <NUM> can be configured to provide sufficient surface area so as to not be traumatic to ocular tissues and/or create accidental cyclodialysis. The indicators <NUM> can be visible to the physician through the cornea when the DV wire <NUM> is extended from the stopper tube <NUM>. In addition, the indicators <NUM> can be visible through the cornea so that a gonio lens is not needed in order to determine the depth of the iridocorneal angle. Furthermore, the DV system <NUM> can perform sufficient measurements such that a gonio lens is not necessary to perform a procedure. By relieving the need for a gonio lens to conduct a procedure, both procedure time and efficiency can be improved.

The DV wire <NUM> can be stamped, chemically etched, or marked with any number of patterning techniques in order to provide indicators <NUM> that can be seen by a user while inserted in the eye. The indicators <NUM> may exhibit any combination of numbering and or patterning features, with varying degrees of darkness, contrast, size, shape and color.

In some embodiments, the contact tip <NUM> can include a loop <NUM> which can provide additional damping when the contact tip <NUM> is in contact with ocular tissue. In addition, the contact tip <NUM> can be made out of a material that allows the loop <NUM> to deform, such as a soft or flexible material, in order to provide a damping effect. The loop <NUM> can be made out of the same or different material than the rest of the DV wire <NUM>, or the loop <NUM> can be coated with a material, such as a flexible or soft material.

In some embodiments, deformation of the contact tip <NUM> or loop <NUM> can assist in providing a visual cue to the user that the distal end of the DV wire <NUM>, such as the contact tip <NUM> or loop <NUM>, is in contact with tissue. For example, the contact tip <NUM> can include one or more features having a spiral cut or any number of a variety of looped patterns which can allow for visually identifiable movements at low forces. Furthermore, deformation of the loop <NUM> can act as a deformable element which can provide visual cues to the user, such as when the loop <NUM> is in contact with tissue.

The cross section of the DV wire <NUM> can be rectangular, although the shape may vary. For example, the DV wire <NUM> can have a circular, elliptical or any one or more of a variety of cross sections along the length of the DV wire <NUM>. In addition, the edges of the DV wire <NUM> can be smooth and free of sharp edges to avoid damage to tissue. The proximal end of the DV wire <NUM> can have ridges for holding the spring <NUM> in place as well as a hard stop to prevent the spring <NUM> from sliding off the proximal end.

<FIG> shows a cross-sectional view of a part of the DV system <NUM>, including the distal end <NUM> of the handle <NUM>. The DV wire <NUM> of the DV system <NUM> can be coupled to a spring <NUM> at a proximal region which can bias the DV wire <NUM> toward a distally outward direction relative to the handle <NUM>. In addition, the spring <NUM> can resist movement of the DV wire <NUM> in a proximal direction (i.e., into the handle <NUM>) and urge the DV wire in a distal direction (i.e., out of the handle <NUM>).

The spring <NUM> can be a low force spring (i.e., a spring constant in the range of. <NUM> Newtons). The spring <NUM> may be made of Nitinol, stainless steel, titanium, plastics, or other equivalent materials, and may exhibit strain induced deformation. Additionally, the spring <NUM> may be at least one of a tension spring, compression spring, torsion spring, leaf spring, Belleville washer, constant force spring, or urethane spring. The spring <NUM> may be an ultra-low force spring (i.e., less than. <NUM> Newtons) for greater sensitivity, or a higher force spring (i.e., greater than. <NUM> Newtons) for overcoming frictional viscous forces of aqueous fluids.

One or more features may be added or removed from the DV system <NUM> based on its intended use (i.e., disposable, re-usable, etc.). For example, one or more holes through the handle <NUM> and handle plug <NUM> may be included in the system in order to allow for sterilization and re-use of the DV system <NUM>. Other features can be implemented for special or improved use of the DV system <NUM>.

<FIG> shows an example of a part of the distal region of the DV system <NUM> inserted in an eye. The DV system <NUM> can be inserted into the anterior chamber <NUM> of the eye via a corneal or limbal incision such that the DV wire <NUM> can pass across the anterior chamber <NUM> (pursuant to an ab-interno approach) toward the base of the angle, such as below the scleral spur <NUM> and above the iris <NUM>. The distal end of the DV wire <NUM>, such as the contact tip <NUM>, can be pressed against ocular tissue, as shown by way of example in <FIG>.

The DV wire <NUM> can apply a force against ocular tissue while the handle <NUM> and stopper tube <NUM> continue to advance in the direction of the eye. The spring <NUM> can allow the proximal end of the DV wire <NUM> to travel towards the handle plug <NUM> while the handle <NUM> and stopper tube <NUM> continue to travel in the direction of the eye. In some embodiments, the DV wire <NUM> can continue to retract into the handle <NUM> until the proximal end of the DV wire <NUM> abuts the handle plug <NUM>. Retraction of the DV wire <NUM> into the stopper tube <NUM> and handle <NUM> can indicate to the user that the contact tip <NUM> of the DV wire <NUM> is properly positioned, such as the distal end of the DV wire <NUM> is positioned against the base of the angle. This can assist in at least minimizing damage to the ocular tissue by preventing the user from applying more force than is necessary when attempting to properly position the DV wire <NUM> in the eye.

Once the surgeon becomes aware that the DV wire <NUM> is properly positioned, the surgeon can then take appropriate measurements, such as of the iridocorneal angle of the eye. Measurements can be made by, for example, referencing the indicators <NUM> along the DV wire <NUM> relative to one or more anatomical features of the eye. After measurements have been taken, the surgeon can then retract the distal end of the DV system <NUM> from the eye. Any number of procedures can follow the removal of the DV system <NUM>, including the insertion of an ocular implant, such as with the delivery system <NUM> described above.

<FIG> shows the distal end of the DV system <NUM>, including the DV wire <NUM>, aligned alongside a distal end of an implant delivery applier <NUM>. The implant delivery applier <NUM> can have an elongated body <NUM> with an adaption feature <NUM> at a distal end <NUM> of the elongated body <NUM>. The adaptation feature <NUM> can be configured to adapt one or more ocular implants <NUM> to the distal end <NUM> of the implant delivery applier <NUM>, as shown in <FIG>. The body <NUM> of the implant delivery applier <NUM> can include indicators or marks <NUM> which correspond with the indicators <NUM> along the DV wire <NUM>, as also shown in <FIG>. The corresponding indicators along the implant delivery applier <NUM> and DV wire <NUM> can allow measurements and positioning of the DV wire <NUM> relative to anatomical features of the eye to be easily replicated with the implant delivery applier <NUM>, as will be discussed in greater detail below.

In addition, the delivery system <NUM> described above can include one or more features of the implant delivery applier <NUM> such that the delivery system <NUM> can be used similarly to the implant delivery applier <NUM> as described herein. For example, the delivery system <NUM> can include one or more indicators or marks which correspond with the one or more indicators <NUM> along the length of the DV wire <NUM>. However, any function or feature disclosed or suggested herein relating to the implant delivery applier <NUM> can be included in the delivery system <NUM>. Similarly, any function or feature disclosed or suggested herein relating to the delivery system <NUM> can be included in the implant delivery applier <NUM>.

<FIG> show an example method of use of the implant delivery applier <NUM> and DV wire <NUM> of the DV system <NUM> having corresponding marks <NUM> and <NUM>, respectively, for properly inserting an implant in the eye. The method shown can be used, for example, to at least acquire one or more measurements of the eye, determine a properly sized implant and implant the properly sized implant, such as the implant <NUM> described above, into the eye. Furthermore, this method can be completed without the use of a gonio lens which can improve the time and efficiency of the procedure.

As shown in <FIG>, a user can first insert the distal end of the DV wire <NUM> through a corneal or limbal incision along the eye and advance the distal end of the DV wire <NUM> across the anterior chamber of the eye (pursuant to an ab-interno approach). Viscoelastic substances or balanced saline solutions may be used to maintain the anterior chamber of the eye and open a space comprising a part of the angle of the eye. The incision can be approximately. <NUM> to <NUM> in length and can be either created by the DV wire <NUM> or a separate instrument. Additionally, the incision can be approximately <NUM> to <NUM> in length.

The user can advance the DV system <NUM> and position the distal end of the DV wire <NUM> against ocular tissue, such as between the scleral spur <NUM> and iris <NUM> in order to measure the depth of the iridocorneal angle. The spring loaded feature of the DV wire <NUM> can assist the user in determining when the distal end, such as the loop <NUM> or contact tip <NUM>, of the DV wire <NUM> is in contact with ocular tissue. For example, the user can continue to advance the DV system <NUM> into the eye until the user begins to observe the stopper tube <NUM> travel over the DV wire <NUM>. Movement of the stopper tube <NUM> relative to the DV wire <NUM> can alert the user that the distal end of the DV wire <NUM> is positioned against ocular tissue within the eye.

Once the user has determined that the distal end of the DV wire <NUM> is positioned against the base of the angle of the eye, such as between the scleral spur <NUM> and iris <NUM>, the user can take measurements of the eye using the DV wire <NUM>. For example, the user can use the indicators <NUM> along the DV wire <NUM> to take measurements of certain anatomical features of the eye, including the depth of the angle of the eye. As shown in <FIG>, the user can view the DV wire <NUM> along a generally vertical line of sight <NUM> in order to observe which indicator <NUM> is aligned with one or more anatomical features of the eye when the distal end of the DV wire <NUM> is positioned against the base of the angle. For example, the user can view the DV wire <NUM> along the vertical line of sight <NUM> and observe which indicator <NUM> is aligned with, for example, the inner edge of the iris <NUM>. Any number of anatomical features can be measured using the indicators <NUM> along the DV wire <NUM> without departing from the scope of this disclosure.

In addition, the user can advance a feature of the DV system <NUM>, such as the stopper tube <NUM>, in order to assist the user in determining which indicator <NUM> is aligned with certain anatomical features of the eye. <FIG> shows an example of the stopper tube <NUM> being used to assist the user in determining which indicator <NUM> or part of the DV wire <NUM> aligns with the inner edge of the iris <NUM> when the distal end of the DV wire <NUM> is placed against the base of the iridocorneal angle in order to measure the depth of the angle. The stopper tube <NUM> can be advanced across the DV wire <NUM> by simply continuing to advance the DV system <NUM> after the distal end of the DV wire <NUM> is positioned against ocular tissue within the angle of the eye, as discussed above.

Once the user has obtained appropriate measurements, the user can remove the DV wire <NUM> from the eye. The implant <NUM> coupled to the implant delivery applier <NUM>, or delivery system <NUM>, can then be inserted into the eye. The same incision that was used to insert the DV wire <NUM> can be used to insert the implant delivery applier <NUM> and implant <NUM>. In addition, the implant <NUM> can be advanced across the eye along the same or similar trajectory such that the distal end of the implant <NUM> contacts generally the same area of ocular tissue between the scleral spur <NUM> and iris <NUM> that the distal end of the DV wire <NUM> had previously contacted while taking measurements.

As shown in <FIG>, the implant delivery applier <NUM> can be advanced in order to allow the implant <NUM> to be inserted into the suprachoroidal or supraciliary space. The user can continue to advance the implant <NUM> into the suprachoroidal or supraciliary space until one or more indicator <NUM> along the implant delivery applier <NUM> aligns with one or more anatomical features of the eye. In particular, the user can advance the implant delivery applier <NUM> until the same indicator <NUM> along the implant delivery applier <NUM> is aligned with the iris <NUM> as was along the DV wire <NUM> when the distal end of the DV wire <NUM> was in contact with the base of the angle (see, for example, <FIG> and <FIG>).

As shown in <FIG>, the user can advance the implant delivery applier <NUM> until the user observes a particular anatomical feature of the eye align with an indicator <NUM> along the implant delivery applier <NUM> which corresponds to an indicator <NUM> along the DV wire <NUM> which had previously been aligned with the same particular anatomical feature, such as when the distal end of the DV wire <NUM> was in contact with the base of the angle. When this corresponding indicator <NUM> on the implant delivery applier <NUM> is aligned with the particular anatomical feature of the eye, the user can determine that the implant <NUM> is properly positioned in the eye for permanent implantation. For example, proper positioning in the eye for permanent implantation includes positioning the implant so that it can provide fluid communication between the anterior chamber and the suprachoroidal or supraciliary space without discomfort or irritation to the eye. Therefore, once the user has aligned the appropriate indicator <NUM> along the implant delivery applier <NUM> with the particular anatomical feature, the user can then release the implant <NUM> from the implant delivery applier <NUM> and remove the implant delivery applier <NUM> from the eye. As shown in <FIG>, the implant <NUM> can then remain in the implanted position permanently or for a desired length of time.

The DV wire can be aligned with the implant delivery applier such that the distal end of the DV wire aligns with a position along the length of the head of the implant <NUM> when the implant <NUM> is coupled to the implant delivery applier <NUM>. The alignment of the distal end of the DV wire <NUM> relative to the head of the implant <NUM> coupled to the implant delivery applier <NUM> can vary depending on the desired placement of the head relative to the anterior chamber of the eye when the implant <NUM> is in its permanently implanted position. For example, and shown by way of example in <FIG>, it may be beneficial to have at least a portion of the head of the implant <NUM> extend into the anterior chamber of the eye. This can assist in ensuring that the implant <NUM> provides a fluid pathway between the anterior chamber and supraciliary or suprachoroidal space.

<FIG> shows an embodiment of a feedback mechanism <NUM> coupled to or comprising the implant delivery applier <NUM>. The feedback mechanism <NUM> can include a sheath <NUM> coupled to a spring <NUM> at a proximal end of sheath <NUM>. In such an embodiment, the spring loaded sheath <NUM> can be used to indicate depth or acknowledge when a certain landmark has been reached. For example, the sheath <NUM> can be positioned such that the distal end of the sheath <NUM> extends a distance over the implant <NUM> attached to the distal end of the implant delivery applier <NUM>. Upon implantation of the implant <NUM> within the eye, the sheath <NUM> can be pushed in the proximal direction, or retracted, when the implant <NUM> has been implanted to a preferred depth within the eye. Retraction of the sheath <NUM> can indicate to a user that the sheath <NUM> has hit a hard stop, such as ocular tissue, and the implant <NUM> has been properly implanted. The implant <NUM> can then be released for permanent implantation once proper implant positioning has been determined.

In addition, the feedback mechanism <NUM> can assist the user in positioning the implant <NUM> such that the proximal end of the implant <NUM> is in direct communication with the anterior chamber of the eye in an implanted state. This can ensure that the implant <NUM> can provide a fluid path from the anterior chamber of the eye to another part of the eye, such as to the suprachoroidal or supraciliary space, and improve fluid flow within the eye.

Furthermore, the DV system <NUM> can be used for a variety of surgical procedures. For example, the DV system can be used to accurately locate and take measurements relating to a variety of anatomical structures, such as the trabecular meshwork and the Schlemm's Canal. The various measurements taken with the DV system <NUM> can be used for accurately positioning implants into one or more anatomical structures, including at least the trabecular meshwork and Schlemm's Canal.

Furthermore, in some embodiments, the distal end of the DV system <NUM>, such as the distal end of the DV wire <NUM>, can include noncontact measuring features for determining one or more of a measurement or a distance within the eye. For example, the distal end of the DV wire <NUM> can include one or more measuring features which can include ultrasound, infrared, optical coherence tomography, or the like. In some embodiments, the measuring features can assist in measuring the relative distance of an anatomical feature of the eye relative to a part of the DV wire <NUM>, such as the distal end. Additionally, the DV wire <NUM> can include various other features which can assist in providing information to a user, such as pressure and temperature sensors.

In some embodiments, the handle can include a display which can indicate to a user one or more parameters measured by the DV system <NUM>, such as by a measuring feature of the DV system <NUM>. Information displayed on the display can include, for example, at least one or more of a distance measured between the distal end of the DV wire <NUM> and an anatomical feature, a measurement of an anatomical feature, a pressure exerted by the distal end of the DV wire <NUM> against tissue, pressure within the eye or temperature.

At least some optical implants are small, such as having lengths and widths on the order of millimeters, which can make it difficult for a user to manipulate the implant. In particular, it can be difficult for the user to prepare the implant for loading as well as loading the implant onto a delivery device, such as the implant delivery applier <NUM> and delivery system <NUM> described above. Therefore, it can be beneficial to have a device which can assist in protecting the implant, including the implants <NUM> and <NUM> disclosed herein, prior to loading onto a delivery device. In addition, it can be beneficial to have a device which can assist in loading the implant onto the delivery device. Furthermore, it can be beneficial to have a device which assists in ensuring that the implant is properly loaded onto the delivery device without damaging the implant.

The present disclosure includes a pencap implant loader which can assist in protecting the implant, including during storage and loading the implant onto a delivery device. In addition, the pencap implant loader can assist in loading the implant onto the delivery device and ensure that the implant is properly loaded onto the delivery device without damaging the implant. Therefore, the pencap implant loader embodiments disclosed herein can improve surgery time, streamline surgery procedures, and at least minimize implant loading related complications.

<FIG> illustrate an embodiment of a pancap implant loader <NUM> which includes an implant housing <NUM> and a delivery device adapter <NUM>. The implant housing <NUM> can be configured to house an implant at least either prior to or during loading of the implant onto the delivery device. In addition, the implant housing <NUM> can be configured to house a variety of one or more implants, including the implants <NUM> and <NUM> disclosed herein.

The delivery device adapter <NUM> can be configured to adapt to any number of implant delivery devices, including the implant delivery applier <NUM> and delivery system <NUM> described above. In some embodiments, the delivery device adapter <NUM> can include a pair of retention arms <NUM> which can have retention features <NUM> which can grasp and secure the delivery device in a position relative to the pencap implant loader <NUM>. For example, the retention arms <NUM> and retention features <NUM> can secure the delivery device relative to the pencap implant loader <NUM> such that the delivery device can effectively and efficiently load the implant contained in the implant housing <NUM> onto the delivery device. Furthermore, the retention arms <NUM> and retention features <NUM> can secure the delivery device such that an implant loading feature of the delivery device is aligned with the implant housing <NUM> in order to allow the implant loading feature, such as a guidewire, to load the implant correctly and without damage to the implant.

In some embodiments, the delivery device adapter <NUM> can include at least one spring loaded retention arm <NUM>, as shown in <FIG>. The spring loaded retention arm <NUM> can allow a user to squeeze the retention arms <NUM> in order to couple or decouple the delivery device from the pencap implant loader <NUM>. In addition, the retention features <NUM> can securely mate with features along the delivery device in order to secure the coupling between the pencap implant loader <NUM> and the delivery device.

The retention arms <NUM> can be made out of a variety of materials, including materials that provide the retention arms <NUM> with spring-loading for coupling and decoupling the delivery device. However, the retention arms <NUM> can be made out of one or more of a variety of materials. In addition, the retention arms <NUM> can include one or more gripping features <NUM>, including ridges along a length of the handle. The gripping features <NUM> can assist a user in grasping and manipulating the pencap implant loader <NUM>.

In some embodiments, the pencap implant loader <NUM> can include a relief <NUM> which can assist in allowing a distal end of the delivery device to mate with the pencap implant loader, such as without becoming jammed in the pencap implant loader <NUM>. In addition, the relief <NUM> can assist in allowing the retention arms <NUM> to couple and decouple the delivery device, such as by allowing additional movement of the retention arms <NUM>.

The pencap implant loader <NUM> can be made out of any number of a variety of materials, including stainless steel, titanium, plastics, or any medical grade or similar materials. In addition, the pencap implant loader <NUM> can include a passageway <NUM> which extends through at least a part of the pencap implant loader <NUM>. The passageway <NUM> can allow the implant to load into the implant housing <NUM> as well as allow a guidewire or other component of the delivery device to advance into the pencap implant loader <NUM> in order to load the implant onto the delivery device.

In some embodiments, the passageway <NUM> can include more than one inner diameter. For example, a distal segment <NUM> of the passageway can have the smallest diameter along the length of the passageway <NUM> which can be sized and shaped to allow a guidewire to pass through. In addition, the implant housing <NUM> can comprise a middle second segment of the passageway <NUM> which can be sized and shaped to allow the implant and guidewire to be inserted. However, the distal segment <NUM> can be sized and shaped to only allow the guidewire to pass through and prevent the implant from passing through. This can ensure that the implant is properly contained within the implant housing <NUM> and cannot travel more distal than the implant housing <NUM>.

In addition, the passageway <NUM> can include a proximal third segment <NUM> which can have a larger diameter than either the distal segment <NUM> or the implant housing <NUM> in order to allow at least the implant and guidewire to pass through. The third segment <NUM> can also be sized and shaped to allow a distal part of the delivery device to insert at least a distance into the third segment <NUM>. For example, the third segment <NUM> can allow at least a part of the stopper tube <NUM> of the implant delivery applier <NUM> to insert a distance within the third segment <NUM>.

As will be discussed below, some embodiments of the pencap implant loader <NUM> can be configured to be coupled to the delivery device, such as the implant delivery applier <NUM>, including during storage of the pencap implant loader <NUM> and delivery device. Therefore, at least one segment of the passageway can be configured to allow at least a part of the delivery device to couple to the pencap implant loader <NUM> in order to allow the delivery device to releasably couple to the pencap implant loader <NUM> for an extended period of time.

An example method of use of the pencap implant loader <NUM> includes coupling the pencap implant loader <NUM> having at least one implant contained in the implant housing <NUM> to the delivery device. The coupled configuration of the pencap loader <NUM> to the delivery device is then packaged and stored for later use by a user. Upon use, the user can remove the coupled configuration of the pencap implant loader <NUM> and the delivery device from the packaging and decouple the pencap implant loader <NUM> from the delivery device. Upon decoupling, the delivery device includes at least one implant that was housed in the implant housing loaded onto the delivery device for implantation into an eye.

In some embodiments, prior to decoupling the pencap implant loader <NUM> from the delivery device, the user can cause an implant delivery feature, such as a guidewire, to extend into the implant housing <NUM> in order to load the at least one implant onto the implant delivery feature. Once the implant delivery feature has sufficiently advanced into the implant housing such that the implant is loaded onto the implant delivery feature, the pencap implant loader <NUM> can be decoupled from the delivery device.

In some embodiments, the pencap implant loader <NUM> can be loaded with one or more implants and stored prior to use without being coupled to a delivery device. Therefore, upon use, the user can manually couple the pencap implant loader <NUM> to the delivery device in order to load the at least one implant contained in the pencap implant loader <NUM> onto the delivery device.

<FIG> illustrate another embodiment of the pencap implant loader <NUM> including an implant housing <NUM> and a delivery device adapter <NUM>. The pencap implant loader <NUM> can include one or more of the same features as discussed above with regards to the pencap implant loader <NUM>, including a distal first segment <NUM> and a proximal third segment <NUM>. In addition, the delivery device adapter <NUM> includes a twisting retention feature <NUM> which provides a similar function as the retention arms <NUM> discussed above.

The twisting retention feature <NUM> can include at least one retaining pin feature <NUM> which can assist in coupling the pencap implant loader <NUM> to the delivery device. In some embodiments, in order to decouple the pencap implant loader <NUM> from the delivery device, the user can twist the pencap implant loader <NUM>, such as in the direction of the arrow <NUM> shown in <FIG>. Upon twisting of the pencap implant loader <NUM>, the retaining pin feature <NUM> can assist in relieving the twisting retention feature from securing the coupling between the pencap implant loader <NUM> and the delivery device.

In some embodiments, the pencap implant loader <NUM> and <NUM> can include a feature that either prevents or allows re-capping of the pencap implant loader onto the delivery device. In addition, the pencap implant loader <NUM> and <NUM> can include a springing feature which can bias the implant proximally and bias the implant towards a correct position during loading.

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.

Claim 1:
A delivery system for delivering an ocular implant (<NUM>) into an eye, the delivery system comprising:
a proximal handle portion (<NUM>);
a distal delivery portion (<NUM>) coupled to a distal end of the handle portion (<NUM>) and configured to releasably hold an ocular implant (<NUM>), the ocular implant (<NUM>) being an elongate element having one or more internal lumens, the delivery portion (<NUM>) comprising a sheath (<NUM>) positioned axially over a guidewire (<NUM>), wherein the guidewire (<NUM>) is configured to be inserted longitudinally through one of the one or more internal lumens of the ocular implant (<NUM>), wherein the guidewire (<NUM>) includes at least one retention feature along a length of the guidewire (<NUM>) which assists in retaining the ocular implant (<NUM>) along the length of the guidewire (<NUM>), and wherein the at least one retention feature includes at least one S-shaped curve (<NUM>); and
an actuator (<NUM>) coupled to a mechanism that releases the ocular implant (<NUM>) from the delivery portion (<NUM>) upon actuation of the actuator (<NUM>), wherein the mechanism is configured to retract the guidewire (<NUM>) upon actuation of the actuator (<NUM>) and release the ocular implant (<NUM>).