Intraocular shunt inserter

Abstract

To provide a shunt inserter which can increase the precision while reducing operator effort and surgery time.SOLUTION: An inserter 100 can include a housing 102 and a slider component 106. The slider component can be coupled to the housing and positioned along an outer surface thereof. The slider component can be slidable along an elongate slot 110 of the housing and include a guide tab disposed within a guide channel 111 of a housing body. The slider can include a friction tab having a biasing member configured to urge against the housing body to urge the guide tab against a wall of the guide channel. Further, a deflector component can be provided that includes a needle guide configured to receive the needle of the inserter therein. The deflector component can be removably coupled to the inserter in order to permit the needle guide to bend the needle and maintain the needle in a bent configuration.SELECTED DRAWING: Figure 1B

Description

[Background technology]

[0001] Glaucoma is an eye disease that affects millions of people. It is associated with elevated intraocular pressure resulting from either failure of the eye's drainage system to adequately remove aqueous humor from the anterior chamber of the eye or excessive production of aqueous humor by the eye's ciliary body. The accumulation of aqueous humor and the resulting intraocular pressure can cause irreversible damage to the optic nerve and retina, which can lead to irreversible retinal damage and blindness.

[0002] Glaucoma can be treated in many different ways. One method of treatment involves delivering drugs, such as beta-blockers or prostaglandins, to the eye to reduce aqueous humor production or increase aqueous humor flow from the anterior chamber of the eye. Glaucoma filtration surgery is a surgical procedure commonly used to treat glaucoma. This procedure involves placing a shunt in the eye to relieve intraocular pressure by creating a pathway for aqueous humor to drain from the anterior chamber of the eye. The shunt is typically positioned in the eye to create a drainage pathway between the anterior chamber of the eye and the area of ​​low pressure. Such a fluid flow path allows aqueous humor to exit the anterior chamber.

[0003] The importance of lowering intraocular pressure (IOP) in slowing the progression of glaucoma is well documented. When medical therapy fails or is not tolerated, surgical intervention is required. There are various surgical filtration methods for lowering intraocular pressure by creating a fluid flow path between the anterior chamber and the subconjunctival tissue. In one particular method, an intraocular shunt is implanted using an inserter by directing a needle holding the shunt through the cornea, across the anterior chamber, and through the trabecular meshwork and sclera into the subconjunctival space. See, for example, U.S. Patent Nos. 5,929,949; 5,929,949; and 5,929,949, the entire contents of which are incorporated herein by reference.

[0004] Existing inserters may have parts that move unnoticed and may not always provide the desired level of precision and feedback during the procedure. During the procedure, the operator may not be able to distinguish between different stages of the insertion process, such as shunt insertion and needle retraction. This may require the operator to manually or visually confirm steps in the procedure, increasing the amount of time an attentive operator must devote to each step of the procedure. This, in turn, increases surgical time and potentially causes significant trauma to the patient, yet the operator may rely on tactile or visual recognition of parts without confidence that a particular milestone or position has been achieved. [Prior art documents] [Patent documents]

[0005] [Patent Document 1] U.S. Patent No. 6,544,249 [Patent Document 2] US Patent Application Publication No. 2008 / 0108933 [Patent Document 3] U.S. Patent No. 6,007,511 [Patent Document 4] U.S. Patent No. 9,585,790 [Patent Document 5] U.S. Patent No. 8,721,792 [Patent Document 6] U.S. Patent No. 8,852,136 [Patent Document 7] US Patent Application Publication No. 2012 / 0123434 [Patent Document 8] US Patent Application Publication No. 2012 / 0197175 [Patent Document 9] US Patent Application Publication No. 2015 / 0011926 [Patent Document 10] US Patent Application Publication No. 2016 / 0354244 [Patent Document 11] U.S. Patent Application Serial No. 15 / 613,018 [Patent Document 12] U.S. Patent Application Serial No. 13 / 336,803 [Patent Document 13] U.S. Patent Application Serial No. 12 / 946,645 [Patent Document 14] U.S. Patent Application Serial No. 12 / 620,564 [Patent Document 15] U.S. Patent Application Serial No. 12 / 946,653 [Patent Document 16] U.S. Patent Application Serial No. 12 / 946,565 [Patent Document 17] U.S. Patent Application Serial No. 11 / 771,805 Summary of the Invention [Problem to be solved by the invention]

[0006] Accordingly, the present disclosure addresses these issues and provides solutions to these issues, and in some embodiments is directed to the realization that certain advantageous features can be implemented in a shunt inserter to increase precision while reducing operator effort and surgical time. [Means for solving the problem]

[0007] Some embodiments disclosed herein provide an intraocular shunt inserter having an actuator that allows an operator to deliver and / or release an intraocular shunt. The inserter can be configured to provide a friction track or resistance, whether sliding or rotating, against which the operator can move the actuator. This resistance to movement ensures that the inserter exposes or releases the shunt only when intended by the operator. Furthermore, this resistance can help the operator operate the inserter with greater precision and control.

[0008] Optionally, some embodiments can include one or more feedback components that can serve as indicators of the completion of an action or step in a procedure. For example, the inserter can include an actuator that can provide one or more audible clicks and / or increased resistance barriers, whether sliding or rotating, that can serve as a signal to the operator that a particular position or step in a procedure is complete. In some embodiments, the slider component can contact a first engagement structure or indicator on the inserter to create an audible click or barrier of increased resistance. By continuing to move beyond the click or increased resistance barrier, the operator can move the slider component toward a second, third, fourth, or other engagement structure or indicator that can create an audible click and / or increased resistance barrier, signaling to the operator that the slider component has been advanced into position and / or that an additional position or step in a procedure has been completed. Thus, the inserter can advantageously provide improved precision and feedback to the operator.

[0009] Additionally, some embodiments disclosed herein may optionally provide an inserter with a bent shaft or needle, which can provide greater tactile control of the inserter and improved clearance during a procedure. The needle may extend from the distal end portion of the inserter and include a bend where the needle's longitudinal axis changes direction along a different axis. The bend may allow the operator to more easily manipulate and / or sense the position of the needle's bevel during a procedure. Thus, some embodiments may advantageously allow the operator to more easily visually confirm that a particular result has been achieved. For example, by rotating the needle's bevel, the operator may "tent" the conjunctiva of the eye, thereby facilitating placement and delivery of the intraocular shunt to a subconjunctival target location. Furthermore, the bend may allow the longitudinal axis of the inserter housing to be spaced a greater distance from the patient's face during a procedure compared to a straight needle-type inserter.

[0010] For example, the inserter can include a housing and a slider component. The housing includes a distal portion, a proximal portion, a longitudinal axis extending between the distal portion and the proximal portion, an internal cavity, and an elongated slot extending into the cavity along an outer surface of the housing. The slider component can be coupled to the housing and positioned along the outer surface of the housing. The slider component can be slidable along the elongated slot to operate the inserter. The slider component can include a guide tab disposed in a guide channel of the housing body. The slider component can also include a friction tab with a biasing member configured to press against the housing body to press the guide tab against a channel wall of the guide channel.

[0011] The operator can operate the inserter by pressing the slider component along the inserter's axis. The slider component can actuate the inserter's deployment mechanism to deliver and release the intraocular shunt. To do so, the operator must overcome an initial frictional force against the housing provided by the slider component's friction tabs. The operator can use the slider component to advance the inserter's plunger, forcing the shunt into the needle lumen.

[0012] During operation of the inserter, the operator can receive tactile or visual feedback from the engagement structure on the housing, for example, as a friction tab moves across the engagement structure. The feedback can correspond to the position of the shunt relative to the needle within the inserter. The feedback can be provided by a discontinuity in the housing.

[0013] For example, in some embodiments, the inserter can generate an audible signal using a biasing member configured to engage a discontinuity in the housing body. The audible or tactile signal can indicate the position of the slider component relative to the inserter and / or can indicate the position of the shunt or stage of shunt delivery.

[0014] The accompanying drawings, which are included to provide a further understanding of the subject technology and are incorporated in and constitute a part of this specification, illustrate aspects of the disclosure and, together with the description, serve to explain the principles of the subject technology. [Brief explanation of the drawings]

[0015] [Figure 1A] 1A-1C are schematic illustrations of a procedure for implanting an intraocular shunt into an eye using an inserter, according to some embodiments. [Figure 1B] FIG. 1 is a perspective view of an inserter for implanting an intraocular shunt into an eye, according to some embodiments. [Figure 2] FIG. 1C is a perspective exploded view of the inserter shown in FIG. 1B, according to some embodiments. [Figure 3] FIG. 1C is a perspective exploded view of a drive assembly of the inserter shown in FIG. 1B, according to some embodiments. [Figure 4A] 1C illustrates a slider component of the inserter shown in FIG. 1B, according to some embodiments. [Figure 4B] 1C illustrates a slider component of the inserter shown in FIG. 1B, according to some embodiments. [Figure 4C] 1C illustrates a slider component of the inserter shown in FIG. 1B, according to some embodiments. [Figure 5] 1 is a cross-sectional view of an inserter for implanting an intraocular shunt into an eye, according to some embodiments. [Figure 6A] 1 is a cross-sectional view of an engagement structure of an inserter according to some embodiments. [Figure 6B] 1 is a cross-sectional view of an engagement structure of an inserter according to some embodiments. [Figure 6C] 10A-10C are cross-sectional views of engagement structures of an inserter according to some embodiments. [Figure 7A] FIG. 4 is a perspective view of a sleeve mount of the drive assembly shown in FIG. 3 having a straight shaft, according to some embodiments. [Figure 7B]FIG. 4 is a perspective view of a sleeve mount of the drive assembly shown in FIG. 3 having a bent shaft, according to some embodiments. [Figure 8A] FIG. 10 is a perspective view of an inserter having alignment guides for providing a bend in the shaft of the inserter, according to some embodiments. [Figure 8B] FIG. 10 is a perspective view of an alignment guide coupled to a sleeve, according to some embodiments. [Figure 8C] FIG. 10 is a side view of an alignment guide coupled to a sleeve, according to some embodiments. [Figure 9A] FIG. 10 is a front perspective view of another alignment guide according to some embodiments. [Figure 9B] FIG. 9B is a rear perspective view of the alignment guide of FIG. 9A, according to some embodiments. [Figure 10A] FIG. 10 is a perspective view of an alignment guide coupled to a sleeve with a protective cap, according to some embodiments. [Figure 10B] FIG. 10 is a side cross-sectional view of a bevel protection device received within a needle lumen of an inserter, according to some embodiments. DETAILED DESCRIPTION OF THE INVENTION

[0016] In the following detailed description, numerous specific details are set forth in order to provide a thorough understanding of the subject technology. It should be understood that the subject technology may be practiced without some of these specific details. In other instances, well-known structures and techniques have not been shown in detail so as not to obscure the subject technology.

[0017] Glaucoma is a disease that damages the optic nerve, leading to progressive, irreversible blindness. It is usually associated with increased pressure of fluid (i.e., aqueous humor) inside the eye. Untreated glaucoma can permanently damage the optic nerve, resulting in visual field loss and potentially progressing to blindness. Once lost, this damaged vision cannot be restored.

[0018] In glaucoma, the pressure of aqueous humor in the eye (anterior chamber) increases, and this resulting increase in pressure can cause damage to the vasculature at the back of the eye, particularly the optic nerve. Treatment for glaucoma and other conditions that lead to increased pressure in the anterior chamber involves reducing the pressure in the anterior chamber to normal levels.

[0019] Glaucoma filtration surgery is a surgical procedure typically used to treat glaucoma. This procedure involves placing a shunt within the eye to relieve intraocular pressure by creating a pathway for aqueous humor drainage from the anterior chamber of the eye. Shunts are typically placed in the eye to create a drainage pathway between the anterior chamber and areas of low pressure. Various structures and / or areas of the eye that are targeted for aqueous humor drainage include Schlemm's canal, subconjunctival space, episcleral veins, suprachoroidal space, intra-Tenon's synechiae, and subarachnoid space. Shunts can be implanted using an ab externo approach (e.g., through the conjunctiva and through the sclera to enter internally) or an ab interno approach (e.g., through the cornea, across the anterior chamber, and through the trabecular meshwork and sclera to enter). For example, an ab interno approach for implanting an intraocular shunt in the subconjunctival space is shown, for example, in Yu et al. (Patent Documents 1 and 2) and Prywes (Patent Document 3), the contents of each of which are incorporated herein by reference in their entirety.

[0020] Some methods can include inserting a hollow shaft into the eye, the hollow shaft configured to hold an intraocular shunt. In some embodiments, the hollow shaft can be a part of a deployment device capable of deploying the intraocular shunt. The hollow shaft can be coupled to the deployment device or can be part of the deployment device itself. The deployment device can include devices such as those described in commonly owned U.S. Patent Nos. 6,239,999; ... and U.S. Patent No. 6,239,999, filed November 15, 2010, the contents of each of which are incorporated herein by reference in their entirety.

[0021] As noted above, conventional deployment devices or inserters may not provide the desired level of precision and feedback, requiring additional operator effort and surgical time. The present disclosure provides various embodiments of methods and devices that can enable an operator to implant a shunt using an inserter with improved comfort, feedback, and precision, while reducing surgical time. As used herein, the term "shunt" includes hollow microstomy tubes similar to the type generally described in U.S. Patent Application Publication No. 2007 / 0129994, as well as other structures containing one or more lumens or other flow paths therethrough.

[0022] According to some embodiments, the inserter can be advanced into the eye via an ab interno or ab externo approach. The shunt can then be deployed from the shaft into the eye, creating a passageway from the anterior chamber into a low-pressure area, such as Schlemm's canal, the subconjunctival space, the episcleral vein, the suprachoroidal space, the intra-Tenon's synechiae, the subarachnoid space, or another area of ​​the eye. The hollow shaft is then withdrawn from the eye. Methods for delivering and implanting bioabsorbable or permanent tubes or shunts, as well as implantation devices for performing such methods, are generally disclosed in applicant's applications, including U.S. Patent Nos. 6,219,999; 6,219,999; 6,219,999; 6,219,999; and 6,219,999, each of which is incorporated by reference in its entirety.

[0023] Some methods can be performed by making an incision in the eye before inserting the deployment device. However, in some instances, the method can be performed without making an incision in the eye before inserting the deployment device. In some embodiments, the shaft connected to the deployment device has a sharp point or tip. In some embodiments, the hollow shaft is a needle. Exemplary needles that can be used are commercially available from Terumo Medical Corporation (Elkington, Maryland). In some embodiments, the needle can have a hollow interior and a beveled tip, and the intraocular shunt can be held within the hollow interior of the needle. In some embodiments, the needle can have a hollow interior and a triple-ground point or tip.

[0024] Some methods can be performed without the need to remove anatomical parts or features of the eye, including, but not limited to, the trabecular meshwork, iris, cornea, or aqueous humor. Some methods can be performed without inducing substantial ocular inflammation, such as subconjunctival bleb formation or endophthalmitis. Some methods can be achieved using an ab interno approach by inserting a hollow shaft configured to hold an intraocular shunt through the cornea, across the anterior chamber, through the trabecular meshwork, into the sclera, or into the intra-Tenon's synechiae space. However, some methods can be performed using an ab externo approach.

[0025] In some procedures performed using the ab interno approach, the angle of entry through the cornea can be altered to influence optimal placement of the shunt within the intra-Tenon synechiae space. The hollow shaft can be inserted into the eye at an angle above or below the limbus, as opposed to entering through the limbus. For example, the hollow shaft can be inserted approximately 0.25 mm to approximately 3.0 mm above the limbus. The shaft can be inserted approximately 0.5 mm to approximately 2.5 mm above the limbus. The shaft can also be inserted approximately 1.0 mm to approximately 2.0 mm above the limbus, or any specific value within any of these ranges. For example, the hollow shaft can be inserted approximately 1.0 mm, 1.1 mm, 1.2 mm, 1.3 mm, 1.4 mm, 1.5 mm, 1.6 mm, 1.7 mm, 1.8 mm, 1.9 mm, or 2.0 mm above the limbus.

[0026] Furthermore, in some embodiments, placing the shunt further from the limbus at the exit site, as provided by an entrance angle above the limbus, can provide access to more lymphatic vessels for drainage of aqueous humor, such as the episcleral lymphatic network, in addition to the conjunctival lymphatic system. A larger entrance angle results in a flatter placement within the intra-Tenon's synechiae space and less shunt curvature.

[0027] As discussed in U.S. Patent Application Publication No. 2007 / 0129994, the entirety of which is incorporated herein by reference, in some embodiments, the depth of penetration into the intra-Tenon's synechiae space may be important when performing some methods to ensure proper positioning and functioning of the intraocular shunt.

[0028] In some methods, the distal tip of the hollow shaft can penetrate the sclera and intra-Tenon's space without coring, removing, or causing significant tissue distortion of surrounding ocular tissue. The shunt is then deployed from the shaft. Preferably, the distal portion of the hollow shaft (rather than the distal tip) fully enters the intra-Tenon's space before the shunt is deployed from the hollow shaft.

[0029] According to some embodiments, the hollow shaft can include a flat, beveled needle, such as a triple-ground needle. The beveled tip can initially penetrate the sclera into the intra-Tenon's space by creating a horizontal slit. In some methods, the needle can be advanced further so that the entire flat bevel penetrates the intra-Tenon's space, spreading the tissue open to a full circular diameter.

[0030] Additionally, according to some method aspects, the intra-Tenon channel can be urged open by the flat beveled portion of the needle so that the material around the opening is sufficiently stretched to avoid constriction of the shunt in that zone, thus preventing the shunt from failing due to constriction or shrinkage. Full entry of the flat beveled portion into the intra-Tenon synechiae space creates minor strain and trauma in the localized area. However, this area will eventually surround and conform to the shunt once it is placed in the eye.

[0031] In some embodiments, the inserter can function as a one-handed device, allowing the operator to place their other hand on a fixation device, such as a hook, that holds the eye, thereby facilitating the procedure by providing greater control and precision of placement.

[0032] A diagram of a procedure for treating an eye 12 is shown in Figure 1A, which illustrates the use of a hook 14 to hold the eye 12 and an inserter 100 to introduce an intraocular shunt into the eye.

[0033] 1B-9 show further details of the inserter 100 shown in FIG. 1A. The inserter 100 can be actuated using one hand, thus facilitating use of the inserter by an operator. The inserter 100 can include a housing 102, a needle assembly 104, and a slider component 106. As shown in FIG. 1B, the inserter 100 can be configured such that the slider component 106 is coupled to the housing 102 via a guide channel 111 and is slidable along an elongated slot 110 in the housing 102. The slider component 106 can be selectively movable by the operator to actuate movement of components of the needle assembly 104.

[0034] For example, as the slider component 106 moves distally along the slot 110 (i.e., in a direction toward the needle assembly 104), the slider component 106 can cause or result in the shunt (not shown) being advanced within, and in some embodiments, released from, the needle assembly 104. According to some embodiments discussed further herein, the movement of the slider component 106 can result in translational and / or rotational movement of components of the needle assembly 104. The sliding movement of the slider component 106 can be converted to rotational movement, which can then be converted to movement along the longitudinal axis of the inserter 100. One advantage of this innovative and complex movement conversion mechanism is that it enables embodiments of the inserter to provide precise, measured movement of its components within a compact assembly.

[0035] As shown in FIG. 2 , the needle assembly 104 may include a needle component 120, a plunger 122, and a sleeve component 124. The needle component 120 may include a 25 GA or 27 GA needle. The plunger 122 may be slidably movable within a lumen of the needle component 120 along a longitudinal axis 178 of the inserter 100. Further, the needle component 120 may be slidably movable within a lumen of the sleeve component 124 along the longitudinal axis 178. Each of the needle component 120 and the plunger 122 may be coupled to a respective drive component of a drive assembly 130 disposed within the housing 102. The inserter 100 may be configured such that, when in an assembled state, the needle component 120, the plunger 122, and the sleeve component 124 are aligned along or coaxial with the longitudinal axis 178. Several drive assemblies for actuating the plunger and withdrawing the needle of an inserter are disclosed in U.S. Patent Nos. 5,629,299; ... and 5,629,299, the entireties of which are incorporated herein by reference.

[0036] 2 and 3, the needle component 120, plunger 122, and sleeve component 124 can be operably coupled to the drive assembly 130 and / or the housing 102. For example, the needle component 120 can be coupled to a needle mount 140. The needle mount 140 can be fixedly coupled to a proximal end portion of the needle component 120 such that rotational and longitudinal movement between the needle component 120 and the needle mount 140 is limited or prevented. The needle mount 140 can be enclosed within a distal end portion of the housing 102 when the inserter 100 is assembled. Additionally, as shown in FIG. 3 and described further below, the needle mount 140 can be coupled to the needle driver 164 of the drive assembly 130 (and, in the illustrated embodiment, via a rotational adjustment component 300).

[0037] 3, the plunger 122 can be coupled to a plunger mount 142. The plunger mount 142 can be fixedly coupled to a proximal end portion or a central portion of the plunger 122 and can limit or prevent rotational and longitudinal movement of the plunger 122 relative to the plunger mount 142. Further, as shown in FIG. 3 and described further below, the plunger mount 142 can be coupled to a plunger driver 162 of the drive assembly 130.

[0038] Additionally, the sleeve component 124 can be coupled to a sleeve mount 144. The sleeve mount 144 can be coupled to a proximal end portion of the sleeve component 124 in a manner that prevents rotational and longitudinal movement between the sleeve component 124 and the sleeve mount 144. As discussed below, the sleeve mount 144 can be coupled to a portion 148 of the housing 102.

[0039] As described above, needle component 120, plunger 122, and sleeve component 124 may be operably coupled to drive assembly 130 and / or housing 102. Such coupling may occur via needle mount 140, plunger mount 142, and sleeve mount 144. Needle mount 140, plunger mount 142, and sleeve mount 144 may then be coupled to one or more drive components that engage drive assembly 134 and to housing 102.

[0040] According to some embodiments, the drive assembly 130 is coupled to the needle element 120 and the plunger 122 and can actuate movement of the needle element 120 and the plunger 122 along the longitudinal axis 178 relative to the housing 102. For example, the drive assembly 130 can be configured to rotate or slide within the housing 102. The drive assembly 130 can transmit longitudinal or axial forces along the longitudinal axis 178 to the needle element 120 and / or the plunger 122, independently or simultaneously, resulting in movement of the needle element 120 and the plunger 122 relative to the housing 102 along the longitudinal axis 178.

[0041] As discussed herein, movement of the slider component 106 can result in movement of the drive assembly 130, which can result in movement of the components of the drive assembly 130 relative to the housing 102. Some embodiments can be configured such that the slider component 106 can be longitudinally movable or slidable along the longitudinal axis 178 relative to the housing 102 to drive or linearly move the needle component 120 and plunger 122, and thus the shunt.

[0042] 3, drive assembly 130 can include drive component 160, plunger driver 162, and needle driver 164. In some embodiments, longitudinal or linear movement of slider component 106 along longitudinal axis 178 can translate to cause rotation of drive component 160 of drive assembly 130, which can then translate to cause longitudinal or linear movement of needle component 120 and plunger 122 along longitudinal axis 178 relative to the housing. According to some embodiments, movement of the components along longitudinal axis 178 can be parallel to longitudinal axis 178.

[0043] FIG. 3 also illustrates one embodiment of the drive component 160. The drive component 160 may include a groove 170 that may be configured to engage a corresponding protrusion (not shown) on the slider component 106. Additionally, the drive component 160 may also include first and second drive grooves 172, 174 that may be configured to slidingly engage corresponding protrusions on the plunger driver 162 and the needle driver 164. Thus, the slider component 106 may include the protrusion 430 (shown in FIG. 4B ), the plunger driver 162 may include the protrusion 182, and the needle driver 164 may include the protrusion 184. This arrangement of slots and protrusions may facilitate the transfer of motion from the slider component 106 to the respective one of the needle component 120 and the plunger 122. Additionally, the plunger driver 162 and the needle driver 164 may include rounded bodies that, when seated within the drive component 160, contact and slide against an inner guide surface 198 of the drive component 160.

[0044] 4A-4C illustrate the slider component 106 of the inserter 100 shown in FIG. 1B , according to some embodiments. FIG. 4A illustrates a perspective view of the slider component 106. The slider component 106 can include a slider body 402 having a proximal end portion 406 and a distal end portion 404. The slider body 402 can have a generally semi-cylindrical shape. The proximal end portion 406 and the distal end portion 404 can include a raised distal boundary or edge 405 and a raised proximal boundary or edge 407 that protrude radially from the slider component 106 to provide a secure and ergonomic grip by an operator's thumb or finger during use.

[0045] The slider component 106 can include one or more guide tabs 410. The guide tabs 410 can be disposed on the distal end portion 404 and the proximal end portion 406. For example, the guide tabs 410 can extend inward toward an interior region 412 of the slider component 106. The interior region 412 of the slider component 106 can include a generally semi-cylindrical shape or cavity that can be configured to be coupled to the inserter 100, for example, by receiving a portion of the inserter 100 therein. When coupled to the inserter 100, the guide tabs 410 can be disposed within the guide channels 111 of the housing 102 to couple the slider component 106 to the housing 102. Thus, as described herein, the guide tabs 410 of the slider component 106 can be retained within the guide channels 111, thereby restraining radial movement of the slider component 106 relative to the housing 102 while simultaneously allowing axial or longitudinal movement of the slider component 106 along the housing 102.

[0046] Optionally, the slider component 106 can be configured to include multiple guide tabs 410 that extend radially inward into the interior region 412 from opposing faces or edges of the slider component 106. For example, as shown in FIG. 4B , the slider component 106 can include a pair of guide tabs 410 that extend radially inward from an inner edge 414 of the slider component 106. The guide tabs 410 can be spaced between about 90 degrees and about 180 degrees apart from one another along the inner surface of the inner edge 414 or the interior region 412.

[0047] Additionally, in some embodiments, the guide tabs 410 can be chamfered to allow the slider component 106 to be pushed or snapped onto the housing 102 and into the guide channel 111. For example, one or more of the guide tabs 410 can include a chamfered portion that faces away from the interior region 412. In this way, when the slider component 106 is pressed against the housing 102, the slider component 106 can flex slightly, opening the interior region 412, until the guide component 410 snaps into place within the guide channel 111.

[0048] FIG. 4B shows a bottom view of the slider component 106. Referring to FIG. 4B, the protrusion 430 can be integrally formed with the body 402 of the slider component 106. However, according to some embodiments, the protrusion 430 can also be formed as a separate component that is later attached to the body 402 of the slider component 106. As described herein, motion of the slider component 106 can be transmitted to the drive assembly 130 via the protrusion 430, thereby causing motion of the components of the drive assembly 130 relative to the housing 102. In some embodiments, the protrusion 430 can be located at the proximal end portion 406 of the slider component 106. In some embodiments, the protrusion 430 can be located at the distal end portion 404 of the slider component. In some embodiments, the protrusion 430 can be located between the proximal end portion 406 and the distal end portion 404.

[0049] FIG. 4C shows a top view of the slider component 106. Referring to FIGS. 4B and 4C, the friction tab 420 can be integrally formed with the body 402 of the slider component 106. As used herein, "integrally formed" can be defined as formed as a single continuous component or piece. Such a component can be injection molded as a single continuous component, or can start as a single part that is later machined or otherwise processed to create various features that are joined together from a single continuous piece of material. For example, through a process such as injection molding or laser beam machining, the friction tab 420 can be formed by creating a slot 422, which defines the shape of the friction tab 420 and allows the friction tab 420 to move relative to the body 402. The friction tab 420 can be attached to the body 402, for example, by a cantilever connection or via a pivot or attachment point 424. The attachment point 424 can be reinforced or include additional body material to improve cyclic fatigue strength. In some embodiments, the friction tabs 420 can be formed as separate pieces that are subsequently attached to the body 402 of the slider element 106 .

[0050] 4B, the friction tab 420 can include a biasing member or friction protrusion 426 that extends radially beyond the adjacent portion of the body 402. The protrusion 426 can extend radially inward toward or into the interior region 412. The protrusion 426 can be tapered or chamfered to allow the slider component 106 to move in one direction and resist movement in the opposite direction over one or more engagement structures, such as notches, serrations, slots, protrusions, or ridges, on the housing 102.

[0051] For example, the protrusion 426 may include a deflection-promoting distal surface that extends at an obtuse angle relative to the inner surface of the slider component 106 and faces the distal boundary or edge 405. Thus, in some embodiments, the friction tab 420 may be movable or deflectable relative to the body of the slider component 106, and the distal surface of the protrusion 426 may be capable of initiating radial deflection as it slides axially over engagement structure formed on the housing 102. Such a configuration is shown in the side view of FIG. 6A . Thus, the distal surface of the protrusion 426 may be configured to enable or facilitate distal movement of the slider component 106 along the housing 102.

[0052] Additionally, the protrusion 426 can include an anti-reverse proximal surface that extends perpendicularly from the inner surface of the slider component 106 or at an angle (e.g., at an acute angle in the case of a protrusion or at an obtuse angle in the case of a notch) relative to the inner surface of the slider component 106. Thus, the proximal surface of the protrusion 426 can be configured to capture or limit proximal movement of the slider component 106 along the housing 102.

[0053] In some embodiments, the engagement structure of the housing 102 can include a cross-sectional profile that promotes deflection, such as a rounded or angled shape (e.g., extending an obtuse angle from the outer surface 440 of the housing 102) along a proximal-facing portion of the engagement structure that first contacts the protrusion 426 as the slider component 106 advances distally along the housing 102. Additionally, in some embodiments, both the proximal-facing and distal-facing portions of the engagement structure can include a cross-sectional profile that promotes deflection.

[0054] Optionally, the engagement structure of the housing can include an anti-reverse cross-sectional profile. For example, the engagement structure can include an edge that extends perpendicularly or at an angle (e.g., an obtuse angle in the case of a protrusion or an acute angle in the case of a notch) from the outer surface 440 of the housing 102. In some embodiments, the distal facing portion of the engagement structure can include an anti-reverse cross-sectional profile. In this manner, the distal facing portion of the engagement structure can hook onto or engage the proximal surface of the protrusion 426 to limit proximal movement of the slider component 106 along the housing 102. Also, in some embodiments, the proximal facing portion of the engagement structure can include a cross-sectional profile that promotes deflection, and the distal facing portion of the engagement structure can include an anti-reverse cross-sectional profile.

[0055] Optionally, as described further herein, the protrusions 426 and / or engagement structure can be shaped to provide audible and / or tactile feedback to the operator. As will be appreciated by those skilled in the art, the snap or click can be created by deflecting the friction tabs 420 and rapidly allowing the friction tabs 420 to release and contact the outer surface 440 of the housing 102. This can be achieved in a variety of ways, including when the engagement structure includes a vertical portion that allows the protrusions 426 of the friction tabs 420 to rapidly move radially into contact with the outer surface 440 of the housing 102. For example, the distally facing portion of the engagement structure can extend perpendicular to the outer surface 440 of the housing 102, such that distal advancement of the slider component 106 over the engagement structure causes the protrusions 426 to snap radially inward against the outer surface 440 of the housing 102, thereby providing audible and / or tactile feedback to the operator.

[0056] 5, one embodiment of the inserter 100 is shown with the slider component 106 attached to the housing 102 by engaging the guide tabs 410 in the guide channels 111. In some embodiments, the guide channels 111 are located on opposite sides of the housing 102. For example, the guide tabs 410 and / or the guide channels 111 can be oriented at different angular positions along the slider component 106 and / or the housing 102, such as approximately 180 degrees apart, less than 180 degrees apart, less than 170 degrees apart, less than 160 degrees apart, or less than 150 degrees apart.

[0057] When the slider component 106 engages the guide channel 111, the protrusion 426 can contact a portion of the housing 102. For example, the protrusion 426 can contact the housing 102 adjacent the slot 110. In some embodiments, the protrusion 426 can be positioned to contact the housing 102 opposite the slot 110.

[0058] The protrusion 426 can be biased into contact with the housing 102. In some embodiments, the protrusion 426 can contact the housing 102 and urge or deflect the friction tab 420 radially away from the housing 102, for example, by deforming along the length of the friction tab 420 or at the attachment point 424. In some embodiments, the body of the friction tab 420 and / or the attachment point 424 can resist this deflection or deformation and provide a reaction force against the housing 102 via the friction tab 420 and the protrusion 426. In some embodiments, the attachment point 424 and the friction tab 420 can be biased to provide a biasing force. This biasing force can urge the slider component 106 radially away from the housing 102, thereby forcing the guide tab 410 of the slider component 106 to press against the inside of the guide channel 111. Thus, the guide tabs 410 limit the radial outward movement of the slider component 106 relative to the housing 102, but the biasing force applied via the friction tabs 420 can increase friction between the slider component 106 and the housing 102. Thus, in some embodiments, the slider component 106 may tend to remain stationary along the housing 102 unless a sufficient axial force is applied to the slider component 106 to overcome the friction between the slider component 106 on the housing 102.

[0059] 5, as the slider component 106 is pushed radially away from the housing 102, the guide tabs 410 move toward the channel wall 111 a of the guide channel 111. Thus, in a stationary state, the slider component 106 is frictionally held between the guide tabs 410 and the channel wall 111 a, and the protrusions 426 of the friction tabs 420 are frictionally held against the outer surface of the housing 102. Advantageously, this arrangement also minimizes radial play within the slider component 106 relative to the housing 102.

[0060] Additionally, the engagement of the friction tabs 420 and the guide tabs 410 with respect to the housing 102 increases the frictional force between the slider component 106 and the housing 102. This allows the slider component 106 to be held in a desired or initial position and prevents inadvertent movement of the slider component 106 during shipping and handling of the inserter 100. Thus, in order to move the slider component 106 and thereby operate the inserter 100, the frictional force of the slider component 106 with respect to the housing 102 must overcome the deliberate and intentional axial force applied by the operator.

[0061] 6A , the friction tabs 420 can further provide tactile and audible feedback to the operator during operation of the inserter 100. During operation, as the slider component 106 advances relative to the housing 102, the friction tabs 420, and more specifically, the friction protrusions 426, can pass over engagement structures 103 formed on the housing 102. Each engagement structure 103 can include a discontinuity in the outer surface 440 of the housing 102, such as a notch, serrations, slot, protrusion, or ridge. The engagement structures 103 can be indexed to reflect different stages of operation of the inserter 100 or the position of the slider component 106 along the housing 102 or slot 110. The housing 102 can be configured to include one or many engagement structures 103. Furthermore, the engagement structures can be grouped together (as a single group or multiple groups) or spaced along the housing 102.

[0062] 6A-6C, the engagement structures 103 can be configured such that the friction tab 420 contacts a first engagement structure 103a (shown as a group of three engagement structures 103, but the first engagement structure 103a can simply include a single engagement structure 103 or two engagement structures 103) within the housing 102 to move the slider component 106 away from its initial position. Similarly, the friction tab 420 can contact a second engagement structure 103b (shown as a group of three engagement structures 103, but the second engagement structure 103b can simply include a single engagement structure 103 or two engagement structures 103) just before the slider component 106 reaches a particular position along its overall path of travel (e.g., halfway along the path of travel or after the shunt inserter has exposed the shunt in the eye and just before continued advancement of the slider begins to retract the inserter needle into the housing). Finally, the friction tab 420 may click against the third engagement structure 103c (although shown as a group of three engagement structures 103c, the third engagement structure 103c may include just a single engagement structure 103 or two engagement structures 103) when the slider element 106 has advanced sufficiently to release the shunt. Feedback may be used to indicate that the inserter 100 is performing different operations, that the shunt or portion of the inserter 100 has reached a particular position, and / or that different operations may require different actuation forces.

[0063] In this manner, the slider component 106 moves along the housing 102 and can provide tactile and / or audible feedback to the operator regarding the position of the slider component 106 relative to the housing 102 and / or the position of the shunt or stage of shunt delivery. In some embodiments, it may be advantageous to provide feedback to the operator when the shunt is first exposed from the needle of the inserter. Additionally, it may also be advantageous to provide feedback to the operator when the inserter has released the shunt (which may not yet be fully exposed outside the needle).

[0064] The type, frequency, and / or intensity of the tactile and / or audible signals may vary depending on the position of the slider component 106, the state of the shunt, and / or the shunt delivery.

[0065] Tactile or audible signals can be provided only when certain milestones are reached, such as the initial movement of the slider component, the initial exposure of the shunt, a position prior to full release of the shunt (e.g., when the sleeve is partially retracted from its fully extended position), and / or a position prior to reaching the final position of the slider component when the shunt is fully released and the needle is fully retracted (or other positions, such as those described in U.S. Patent Application Publication No. 2009 / 0109997, the entire contents of which are incorporated herein by reference). Furthermore, some embodiments can be provided in which tactile feedback is provided only at certain milestones, while audible feedback is provided at other milestones. For example, either tactile or audible feedback can be provided at the beginning, while the other tactile or audible feedback can be provided at later stages of the procedure. Furthermore, either tactile or audible feedback can be provided at the beginning and end to mark the initial and final slider component movements, while the other tactile or audible feedback is provided when the shunt is first exposed and immediately prior to full release of the shunt. Various options and variations of the above can be provided.

[0066] Optionally, the housing 102 may include a plurality of engagement structures 103 that provide continuous, gentle tactile or audible feedback to the operator to indicate that the slider component 106 is advancing.

[0067] Thus, according to some embodiments, the shape of the engagement structure 103 can be varied along the length of the housing 102 to provide varying types, frequencies, and / or intensity of tactile or audible feedback and / or to increase the degree of resistance to the operator force required to apply to move the slider components.

[0068] For example, with respect to the degree of resistance provided by the engagement structure 103, in some embodiments, the engagement structure 103 can be configured to require the operator to overcome successively higher degrees of resistance as the shunt is exposed and ultimately released from the inserter. Thus, the size (e.g., height or axial length) of the engagement structure 103 can increase in the distal direction, thereby creating an increasing degree of resistance to distal advancement of the slider component.

[0069] The engagement structure 103 can define at least one notch, serration, slot, protrusion, ridge, or other modified surface to provide tactile and / or audible signals or feedback to the operator. Referring to FIGS. 6A-6C, various features of the engagement structure 103 are shown. As shown in FIG. 6A, the engagement structure 103 can include one or more notches, serrations, slots, protrusions, or ridges having an outer or cross-sectional profile 502 that can include surfaces that promote deflection and / or anti-reverse surfaces. The radius 504 and spacing 506 of the engagement structure 103 can be varied. In particular, the radius 504 of the engagement structure 103 can be varied to provide stronger feedback or resist movement of the slider component 106.

[0070] 6B, engagement structure 103 can include a vertical distally facing surface 505 that provides a substantial drop off from the tip or height of engagement structure 103. In some embodiments, surface 505 can provide an auditory function, as friction tabs 420 are permitted to ride up contour 502 on the front or proximal side, after which friction tabs 420 spring, snap, or click downward or radially inward against housing 102 to provide an audible and / or tactile signal.

[0071] According to some embodiments, the radius or angle of the contour 502 or the height of the engagement structure 103 can be changed to provide a different sound, tactile signal, or increase the sliding resistance to the slider part 106 as it traverses the engagement structure 103.

[0072] Optionally, when engagement structures 103 are grouped together, the spacing between engagement structures 103 can be varied to change the frequency of the audible signal from the hearing mechanism of friction tab 420.

[0073] As shown in Figure 6C, the engagement structure 103 can include a cross-sectional profile 502 with tapered peaks. The tapered peaks can provide different audible and / or tactile feedback compared to the ridge or sawtooth features shown in Figures 6A and 6B. Similar to the structures shown in Figures 6A and 6B, the height and spacing of the tapered peaks can be varied to provide a desired audible or tactile signal.

[0074] In some embodiments, different engagement structures 103 may utilize different mechanisms to provide different signals to the operator, hi some embodiments, a single engagement structure 103 may utilize a combination of the mechanisms described in Figures 6A-6C.

[0075] As shown, FIG. 7A is a perspective view of a sleeve mount 144 coupled to a straight sleeve component 124, as also shown and discussed in the embodiment of FIG. 2. However, the sleeve component can also be configured to include a bend, as shown in FIG. 7B. FIG. 7B illustrates a sleeve component 124a having a slight curve or bend 290. The bend 290 is adjacent the sleeve mount 144 and can provide an angular deviation 292 of the axis 293 of the sleeve component 124a from the longitudinal axis 178 within a range of between about 3 degrees and about 30 degrees, between about 4 degrees and about 15 degrees, between about 5 degrees and about 13 degrees, or about 8 degrees relative to the longitudinal axis of the inserter 100.

[0076] The bend in sleeve part 124a can improve access to the eye area, such as when the inserter approaches the eye from a position where it is positioned above the cheekbone.

[0077] Also, as shown, the insertion portion or distal end portion 294 of the sleeve component 124a can be substantially straight, while the deployment portion or proximal end portion 296 of the sleeve component 124a can include a curved or bent portion. Furthermore, in some embodiments, both the distal end portion 294 and the proximal end portion 296 can include a bend or can be straight with a bend disposed therebetween. The proximal end portion 296 can be about one-quarter to about one-half of the overall length of the sleeve component 124a. In some embodiments, the length of the proximal end portion 296 can be about one-third of the length of the sleeve component 124a. Thus, in some embodiments, the distal end portion 294 can be about one-half to about three-quarters the length of the sleeve component 124a, and in some embodiments, can be about two-thirds the length of the sleeve component 124a. And advantageously, the distal end portion 294 of the sleeve component 124a may be long enough so that the entire length of the sleeve component 124a entering the eye is substantially straight.

[0078] The sleeve component 124a may comprise a rigid structure capable of withstanding typical bending stresses when performing embodiments of the procedures disclosed herein, while the needle component 120 may be made from a flexible shaft that is deflectable during proximal retraction of the needle component 120 into the sleeve component 124a.

[0079] In this manner, the proximal portion of the needle element 120 extending along the bent portion 290 of the sleeve element 124a can be retracted proximally into the proximal or adjacent sleeve element 124a of the sleeve mount 144. After such action, the proximal portion of the needle element 120 is bent, but the same portion of the needle element 120 can bend and straighten as the needle element 120 is pulled proximally into a straight portion of the needle element 120 or other element within the inserter. Also, the portion of the needle element 120 at the distal end portion of the sleeve element 124a (and thus in a straight configuration) can bend or deflect to a curved or bent configuration as the needle element 120 is retracted proximally through the bent portion 290 of the sleeve element 124a.

[0080] Thus, by using an arcuate or curved sleeve component 124a in combination with a flexible or malleable needle component 120, some embodiments of the inserter can be capable of providing improved access to the eye area.

[0081] Some embodiments may embody aspects of the sleeve structure and methods of use disclosed in Applicant's US Pat. No. 6,229,999, the entirety of which is incorporated herein by reference.

[0082] 8A-10A, in some embodiments, it may be desirable for the shaft or needle element 120 to include a bend for several reasons discussed herein. In some embodiments, the bend can be between about 1 degree and about 20 degrees, about 2 degrees and about 18 degrees, about 3 degrees and about 16 degrees, about 4 degrees and about 14 degrees, about 3 degrees and about 16 degrees, about 5 degrees and about 12 degrees, about 6 degrees and about 10 degrees, or about 1 degree, about 2 degrees, about 3 degrees, about 4 degrees, about 5 degrees, about 6 degrees, about 7 degrees, about 8 degrees, about 9 degrees, about 10 degrees, about 11 degrees, about 12 degrees, about 13 degrees, about 14 degrees, about 15 degrees, about 16 degrees, about 17 degrees, about 18 degrees, about 19 degrees, or about 20 degrees.

[0083] Optionally, in some embodiments, the needle component 120 can be held in a bent configuration. According to some embodiments, the sleeve component 124 can be straight and / or selectively angled or bent using removable or retrofittable end components, deflector components, or alignment guides 602. In some embodiments, the inserter 100 can be delivered with alignment guides 602 coupled to the inserter 100 or disposed on the sleeve component 124.

[0084] 8A , the alignment guide 602 can include a hollow guide shaft 603 coupled to a mounting portion 604. The mounting portion 604 can be keyed or indexable to rotationally orient the alignment guide 602 relative to the housing 102 of the inserter 100. For example, the mounting portion 604 can function to couple the alignment guide 602 to the housing 102 at a desired angular or rotational orientation to set the bending direction and / or the bending direction of the needle relative to the longitudinal axis of the housing 102 of the inserter 100.

[0085] In some embodiments, a hollow guide shaft 603 can be positioned over a portion of the sleeve component 124 and the needle component 120. The guide shaft 603 can have or define an angle similar to the angles of the angled sleeve components described herein. For example, the alignment guide 602 can bend the sleeve component 124 and the needle component 120 at a bend 690 to provide an angular deviation 692 of the axis 693 of the guide shaft 603 from the longitudinal axis 178 of the inserter 100 within a range of between about 0 degrees and about 30 degrees, between about 0 degrees and about 20 degrees, between about 0 degrees and about 15 degrees, or about 8 degrees relative to the longitudinal axis of the inserter.

[0086] Thus, in some embodiments, an operator can modify the needle of an inserter by applying an alignment guide to the inserter, thereby bending the needle to a desired angular orientation. The alignment guide can be provided as part of a set of alignment guides with different angular orientations. The alignment guide can be retrofittable to any existing inserter. Furthermore, the alignment guide can be configured to mate with a distal end portion of the inserter to securely engage the alignment guide rotationally and longitudinally relative to the inserter.

[0087] For example, in some embodiments, as discussed and shown in U.S. Patent Application Publication No. 2009 / 0129990, the entirety of which is incorporated herein by reference, the operator can rotate the needle until the bevel begins to push the conjunctiva away from the sclera. This procedure, which can be referred to as "tenting" the conjunctiva, can create a small cavity or gap between the conjunctiva and the sclera adjacent to the bevel of the needle. Once the cavity is created by tenting the binding agent, the shunt can be advanced from the needle into the cavity. As a result, the conjunctiva is pushed out and no longer immediately impedes the advancement of the shunt into the subconjunctival space, making it substantially easier to push the shunt into the cavity.

[0088] Also, in some embodiments, the insertion or distal end portion 694 of the guide shaft 603 can be substantially straight, while the deployment or proximal end portion 696 of the guide shaft 603 can include a curve or bend. Furthermore, in some embodiments, both the distal end portion 694 and the proximal end portion 696 can include a bend or be straight with a bend disposed therebetween. The proximal end portion 696 can be about one-quarter to about one-half of the total length of the guide shaft 603. In some embodiments, the length of the proximal end portion 696 can be about one-third of the length of the guide shaft 603. Thus, in some embodiments, the distal end portion 694 can be about one-half to about three-quarters the length of the guide shaft 603, and in some embodiments, can be about two-thirds the length of the guide shaft 603.

[0089] The alignment guide 602 can allow an operator to modify the angle of the sleeve component 124 and the needle component 120 prior to a procedure (e.g., by allowing the operator to select from a variety of different angular orientations and relative length configurations of the proximal and distal end portions) without having to replace the needle component 120 of the inserter 100. Additionally, the guide shaft 603 can increase the rigidity of the sleeve component 124 and the needle component 120. In some embodiments, the alignment guide 602 can facilitate the use of smaller gauge needles for the needle component 120, including, but not limited to, 28 gauge or smaller sized needles. Thus, implementations of the present disclosure can advantageously allow very small and delicate needles to be used during delivery of an intraocular shunt while ensuring that the needle exhibits sufficient strength and rigidity during the delivery process.

[0090] The sleeve component 124 and needle component 120 can be flexible or resilient, allowing them to deflect when the alignment guide 602 is installed. The alignment guide 602 can be removed to move the sleeve component 124 and underlying needle component 120 to a default, straight configuration. For example, the alignment guide 602 can be configured to resiliently deform the sleeve component 124. Thus, when the alignment guide 602 is removed, the sleeve component 124 and needle component 120 return to their straight configuration. Furthermore, the alignment guide 602 can be reinstalled in the housing 102, if desired.

[0091] 8A-8C , in some embodiments, proper rotational alignment of the alignment guide 602 can be facilitated by a mounting portion 604 that can be keyed or indexed and that orients the alignment guide 602 relative to the housing 102. An indexing groove 605 in the mounting portion 604 can align with an indexing protrusion 105 on the housing 102. In some embodiments, the indexing groove 605 can be keyed to the indexing protrusion 105 to enable the alignment guide 602 to be mounted on the housing 102 in a desired orientation. Thus, the alignment guide 602 and the inserter 100 can be configured to have one or more preset relative orientations. The indexing groove 605 can be in the form of a longitudinally extending recess or slot formed in the mounting portion 604.

[0092] Additionally, the indexing grooves 605 can be spaced (e.g., circumferentially) apart from one another at equal circumferential distances, and the indexing protrusions 105 can be spaced (e.g., circumferentially) apart from one another at equal circumferential intervals, such that the alignment guide 602 can be rotated to one or more preset rotational orientations. However, the circumferential distance between the indexing grooves 605 and / or the indexing protrusions 105 can vary. In the embodiment shown in FIGS. 8A-8C , there are four preset rotational orientations. In some embodiments, the alignment guide 602 can include a single indexing groove 605 that can mate with a single indexing protrusion 105 on the housing 102 such that the alignment guide 602 has a single rotational orientation relative to the inserter 100.

[0093] The mounting portion 604 can have the same number of indexing grooves 605 as there are indexing protrusions 105. However, in some embodiments, the alignment guide 602 can include more indexing grooves 605 than there are indexing protrusions 105. For example, there can be four indexing protrusions 105 and four indexing grooves 605, but there can also be four indexing protrusions 105 and eight indexing grooves 605, four indexing protrusions 105 and twelve indexing grooves 605, or the ratio of indexing protrusions 105 to indexing grooves 605 can be 1:4, 1:5, 1:6, or more.

[0094] 9A is a front perspective view of another installable end piece, deflector piece, or alignment guide 700, according to some embodiments. Similar to alignment guide 602 shown in FIGS. 8A-8C, alignment guide 700 can be used to bend or maintain sleeve piece 124 in a straight and / or selectively angled or bent configuration. As described herein, certain details or uses of alignment guide 602 can also be implemented in alignment guide 700 and will not be repeated here for the sake of brevity.

[0095] 9A and 9B, the alignment guide 700 can include a guide shaft 702 coupled to a mounting portion 704. Similar to the alignment guide 602, the mounting portion 704 can include one or more indexing grooves 706 that facilitate aligning and / or coupling the alignment guide 700 to the housing 102 of the inserter 100.

[0096] Similar to the alignment guide 602 described above, the inserter 100 can be delivered with the alignment guide 700 coupled to the inserter 100 or disposed on the sleeve component 124. In some embodiments, a hollow guide shaft 702 can be disposed over portions of the sleeve component 124 and needle component 120. The guide shaft 702 can have or determine an angle similar to the angled sleeve components described herein. The alignment guide 700 can bend the sleeve component 124 and needle component 120 to provide an angular deviation 710 of the axis 712 of the guide shaft 702 from the longitudinal axis 178 of the inserter 100 within a range of between about 0 degrees and about 30 degrees, between about 0 degrees and about 20 degrees, between about 0 degrees and about 15 degrees, or about 8 degrees relative to the longitudinal axis of the inserter.

[0097] Also, similar to alignment guide 602, the insertion or distal end portion 720 of guide shaft 702 can be substantially straight, while the deployment or proximal end portion 722 of guide shaft 702 can include a curve or bend. Furthermore, in some embodiments, both distal end portion 720 and proximal end portion 722 can include a bend or be straight with a bend disposed therebetween. Proximal end portion 722 can be about one-quarter to about one-half of the overall length of guide shaft 702. In some embodiments, the length of proximal end portion 722 can be about one-third of the length of guide shaft 702. Thus, in some embodiments, distal end portion 720 can be about one-half to about three-quarters the length of guide shaft 702, and in some embodiments, can be about two-thirds the length of guide shaft 702.

[0098] Similar to the alignment guide 602, the alignment guide 700 may allow the operator to modify the angle of the sleeve component 124 and the needle component 120 (e.g., by allowing the operator to select from a variety of different alignment guides having different angular orientations and configurations of the relative lengths of the proximal and distal end portions) without having to replace the needle component 120 of the inserter 100 prior to the procedure. Additionally, the guide shaft 702 may increase the rigidity of the sleeve component 124 and the needle component 120. In some embodiments, the alignment guide 700 may facilitate the use of thinner gauge needles for the needle component 120, including, but not limited to, needles sized 28 gauge or smaller. Thus, implementations of the present disclosure may advantageously enable the use of very small and delicate needles for the delivery of intraocular shunts while ensuring that the needles exhibit sufficient strength and rigidity during the delivery process.

[0099] Also as noted above, the sleeve component 124 and needle component 120 can be flexible or resilient to allow for flexure when the alignment guide 700 is installed. The alignment guide 700 can be removed to allow movement of the sleeve component 124 and underlying needle component 120 to a default, linear configuration. For example, the alignment guide 700 can be configured to resiliently deform the sleeve component 124. Thus, upon removal of the alignment guide 700, the sleeve component 124 and needle component 120 return to their linear configuration. Furthermore, the alignment guide 700 can be reinstalled in the housing 102, if desired.

[0100] As similarly described above with respect to FIGS. 8A-8C , the alignment guide 700 of FIGS. 9A and 9B can be properly rotationally aligned with the inserter 100 by a keyed or indexable mounting portion 704 that orients the alignment guide 700 relative to the housing 102. An indexing groove 706 in the mounting portion 704 can align with an indexing protrusion 105 on the housing 102. In some embodiments, the indexing groove 706 can align with the indexing protrusion 105 to enable the alignment guide 700 to be mounted on the housing 102 in a desired orientation. Thus, the alignment guide 700 and the inserter 100 can be configured to have one or more preset relative orientations. The indexing groove 706 can be in the form of a longitudinally extending recess or slot formed in the mounting portion 704.

[0101] Additionally, the indexing grooves 706 can be spaced (e.g., circumferentially) apart from one another at equal circumferential distances, and the indexing protrusions 105 can be spaced (e.g., circumferentially) apart from one another at equal circumferential intervals, allowing the alignment guide 700 to be rotated to one or more preset rotational orientations. However, the circumferential distances between the indexing grooves 706 and / or the indexing protrusions 105 can vary. In the embodiment shown in FIGS. 9A and 9B , there are four preset rotational orientations. In some embodiments, the alignment guide 700 can include a single indexing groove 706 that can mate with a single indexing protrusion 105 on the housing 102 such that the alignment guide 700 has a single rotational orientation relative to the inserter 100.

[0102] The mounting portion 704 can have the same number of indexing grooves 706 as there are indexing protrusions 105. However, in some embodiments, the alignment guide 700 can include more indexing grooves 706 than there are indexing protrusions 105. For example, there can be four indexing protrusions 105 and four indexing grooves 706, but there can also be four indexing protrusions 105 and eight indexing grooves 706, four indexing protrusions 105 and twelve indexing grooves 706, or the ratio of indexing protrusions 105 to indexing grooves 706 can be 1:4, 1:5, 1:6, or more.

[0103] According to some embodiments, the mounting portion 704 of the alignment guide 700 may include one or more retention or engagement features that allow the alignment guide to snap into or otherwise engage with corresponding engagement features on the distal end portion of the inserter 100. Such features may also be used in conjunction with the mounting portion 604 of the alignment guide 602.

[0104] According to some embodiments, various components can be used to protect the needle components of the inserter. These components can be used individually or in combination with each other to protect the needle components, such as the bevel of the needle component, from damage during repositioning and / or shipping or delivery of the inserter or needle assembly. Such components that can be used for this purpose include alignment guides 602 or 700, protective caps, and bevel protectors. Examples of these components and their combined use are described below with respect to Figures 10A and 10B.

[0105] 10A and 10B, in some embodiments, the chamfer protector 820 can be inserted into the needle component 120 to protect the chamfer region or chamfer 800 of the needle component 120. As shown in FIG. 10A, in some embodiments, the alignment guide 602 (which can also be the alignment guide 700) is coupled to the inserter 100 and can be used to angle the sleeve component 124 and / or the needle component 120 to protect the sleeve component 124 and / or the needle component 120 by keeping the sleeve component 124 angled toward the protective cap 610 while the chamfer protector 820 is inserted into the needle component 120. Thus, as shown, the chamfer protector 820 can extend distally from the needle component 120 and contact the inner sidewall of the protective cap 610. Thus, by the alignment guide 602 bending the needle element 120 away from the central axis of the protective cap 610 (or towards the side wall of the protective cap 610), the tip chamfer protection device 820 can be configured to contact the side wall of the protective cap 610, thus spacing the tip chamfer 800 of the needle element 120 away from the side wall of the protective cap 610 and avoiding contact with the side wall of the protective cap 610.

[0106] Additionally, the protective cap 610 is configured to engage a portion of the housing 102 to secure the protective cap 610 to a distal portion of the housing 102 to cover and protect the sleeve component 124 and the needle component 120 .

[0107] As noted above, according to some embodiments, the chamfer protector 820 can also be used to reduce or prevent accidental contact between the chamfer 800 of a needle component and other structures, such as the protective cap 610, during shipping and delivery of the inserter or needle assembly. When used in combination with the alignment guide 602 or 700, the alignment guide 602 or 700 can induce the desired contact between the chamfer protector 820 and the protective cap 610 to position the needle component 120 in a protected position. However, in some embodiments, the chamfer protector 820 can be used by itself or in conjunction with either or both of the protective cap 610 or the alignment guide 602 or 700.

[0108] The inserter 100 can be used in combination with a chamfer protector that engages with the needle component 120 of the inserter 100 to prevent accidental damage to the chamfer 800 of the needle component 120. In some embodiments, the chamfer protectors described herein can be used with an angled sleeve component 124 and / or alignment guides 602 or 700 to position the end of the protector relative to the protective cap 610.

[0109] 10B shows the distal end portion of the needle element 120 of the inserter. A chamfer protector 820 can engage with the distal end portion 822 of the needle element 120. The chamfer protector 820 can include an elongate body 824 including a first portion 826 and a second portion 828. The first portion 826 can taper from a larger diameter cross-section to a smaller diameter cross-section. The smaller diameter cross-section can be smaller than the inner diameter of the distal end portion 822 of the needle element 120. In this manner, the first portion 826 can be inserted into the lumen 830 of the needle element 120.

[0110] The elongate body 824 can be configured such that the taper of the first portion 826 provides the elongate body 824 with a variable diameter cross-section. The diameter can taper gradually or in steps.

[0111] 10B , the cross-sectional profile or diameter of elongate body 824 adjacent second portion 828 can be larger than the cross-sectional profile or diameter of elongate body 824 near first portion 826. For example, from first portion 826 to second portion 828, the cross-sectional diameter of elongate body 824 can increase from a diameter smaller than the inner diameter of lumen 830 of the needle element to a diameter larger than the inner diameter of lumen 830. In this manner, elongate body 824 can be inserted into lumen 830 of needle element 120 and advanced to a position where the cross-section of the elongate body is approximately equal to the inner diameter of lumen 830, thereby limiting further advancement of chamfer protector 820 into lumen 830.

[0112] In some embodiments, the elongate body 824 can frictionally engage the distal end portion 822 of the needle element 120. For example, the retention device 820 can be press-fit onto the needle element 120 to create a frictional engagement between the outer surface of the elongate body 824 and the inner surface of the lumen 830. This frictional engagement can be overcome by applying a withdrawal force to the second portion 828 of the retention device 820, thereby pulling the chamfer protector 820 out of the lumen 830.

[0113] While the chamfer protector 820 is shown as having a circular or diametric cross-section, other cross-sections, such as a triangle, square, rectangle, polygon, star, or other similar profile, can also be used. Additionally, the chamfer protector 820 can be made of steel. Advantageously, according to some embodiments, the chamfer protector 820 can only contact the inside of the needle chamfer 800 and therefore does not affect the needle's sharpness, which is effected by the outer edge of the needle.

[0114] The bevel protector 820 can therefore ensure that the edge of the needle bevel 800 does not come into contact with other surfaces to prevent damage during shipping or initial handling of the inserter or needle assembly. When the operator is ready to use the inserter, the bevel protector 820 can be withdrawn from the needle component 120 and the treatment can be performed.

[0115] Additionally, in some embodiments, the inserter 100 may include tactile or audible feedback mechanisms that do not require or create consistent or persistent frictional engagement with the housing 102. Thus, inserter configurations discussed herein may be incorporated into some embodiments while excluding other configurations discussed herein.

[0116] While the detailed description contains many details, these should not be construed as limiting the scope of the subject technology, but merely as illustrating different examples and aspects of the subject technology. It should be understood that the scope of the subject technology includes other embodiments not described in detail above. Various other modifications, changes, and variations can be made in the arrangement, operation, and details of the methods and apparatus of the subject technology disclosed herein without departing from the scope of the present disclosure. Unless otherwise specified, reference to an element in the singular is intended to mean "one and only one" and not "one or more" unless explicitly stated. Also, it is not necessary for an apparatus or method to address every problem solvable by different embodiments of the present disclosure to be encompassed within the scope of the present disclosure. Description of the subject technology as a clause

[0117] Various examples of aspects of the present disclosure are described below as clauses for convenience, which are provided as examples and are not intended to limit the subject technology.

[0118] Clause 1: An intraocular shunt inserter for treating glaucoma, comprising: a housing having a distal portion, a proximal portion, and a longitudinal axis extending between the distal portion and the proximal portion, the housing further including an internal cavity, a guide channel, and an elongated slot, the guide channel extending along the longitudinal axis and accessible along an outer surface of the housing, the guide channel having an inner wall, and the elongated slot extending along the outer surface of the housing and along the longitudinal axis into the internal cavity; an intraocular shunt inserter comprising: a slider component slidably coupled to a housing along its outer surface, the slider component being slidable along the elongated slot to actuate a function of the inserter via the elongated slot; the slider component including a guide tab and a friction tab, the guide tab being slidably disposed within and along a guide channel of the housing, the friction tab being movable relative to the guide tab and including a biasing portion configured to press the friction tab against the housing and bring the guide tab into contact with an inner wall of the guide channel, and to provide frictional resistance to sliding between the slider component and the housing.

[0119] Clause 2: An inserter as described in clause 1, wherein the inserter part includes an internal region into which the housing is fitted.

[0120] Clause 3: The inserter of clause 2, wherein the interior region is semi-cylindrical.

[0121] Clause 4: The inserter of clause 2 or 3, wherein the friction tabs extend inwardly toward an interior region of the slider component to contact an outer surface of the housing.

[0122] Clause 5: The inserter of clause 4, wherein the friction tabs include a pair of friction tabs extending inwardly toward an interior region of the slider component.

[0123] Clause 6: An inserter according to any one of clauses 2 to 5, wherein the guide tabs extend inwardly towards an interior region of the slider component.

[0124] Clause 7: An inserter described in any one of clauses 2 to 6, wherein the guide tabs include a pair of guide tabs extending inward toward an interior region of the slider component.

[0125] Clause 8: An inserter as described in clause 2, wherein the slider component includes a generally cylindrical profile and the guide tabs are spaced apart from each other along the inner surface of the interior region by between about 90 degrees and about 180 degrees.

[0126] Clause 9: An inserter according to any one of clauses 1 to 8, wherein when coupled to the housing, the slider part contacts the housing only via the guide tabs and friction tabs.

[0127] Clause 10: An inserter described in any one of clauses 1 to 9, wherein the guide tabs include a pair of guide tabs, each of the pair of guide tabs including a longitudinally extending flange configured to seat within the guide channel.

[0128] Clause 11: An inserter described in any one of clauses 1 to 10, wherein the housing includes a generally cylindrical contour and the pair of guide channels are spaced apart between about 90 degrees and about 180 degrees from each other along the outer surface of the housing.

[0129] Clause 12: The inserter of clause 11, wherein the guide channels are positioned at approximately 180 degrees from each other.

[0130] Clause 13: An inserter according to any one of clauses 1 to 12, wherein the guide tab, friction tab, and slider component are formed as a single continuous piece of material.

[0131] Clause 14: An inserter according to any one of clauses 1 to 13, wherein the friction tab is formed as a cutout through the body of the slider component.

[0132] Clause 15: The inserter of clause 14, wherein the friction tab includes a protrusion that extends toward an interior region of the slider component.

[0133] Clause 16: The inserter of clause 15, wherein when the slider part is coupled to the housing, the protruding portion of the friction tab contacts the housing.

[0134] Clause 17: The inserter of clause 16, wherein the protrusion of the friction tab contacts the housing to bend the friction tab away from the guide tab.

[0135] Clause 18: The inserter of any one of clauses 1 to 17, wherein the housing comprises a generally cylindrical profile.

[0136] Clause 19: An inserter according to any one of clauses 1 to 18, wherein the housing includes an engagement structure that allows the friction tab to contact the housing to provide audible or tactile feedback to the operator.

[0137] Clause 20: The inserter of clause 19, wherein the engagement structure includes at least one discontinuity in the outer surface of the housing.

[0138] Clause 21: The inserter of clause 19, wherein the engagement structure includes at least one ridge on an outer surface of the housing.

[0139] Clause 22: The inserter of clause 19, wherein the engagement structure includes a plurality of sawtooth formations on an outer surface of the housing.

[0140] Clause 23: The inserter of clause 19, wherein the engagement structure includes a plurality of tapered peaks on an outer surface of the housing.

[0141] Clause 24: An inserter as described in clause 19, wherein the function of the inserter includes advancing the shunt within the needle, and the position of the slider component along the engagement structure corresponds to the deployment position of the shunt relative to the needle.

[0142] Clause 25: An inserter as described in Clause 19, wherein the engagement structure includes a plurality of ridges on the outer surface of the housing, each of the ridges corresponding to a deployment position of the intraocular shunt.

[0143] Clause 26: An inserter described in any one of clauses 1 to 25, wherein the slider component is operably coupled to a deployment mechanism within the housing.

[0144] Clause 27: An inserter according to clause 26, wherein the slider component is coupled to the deployment mechanism via a rod extending through the elongated slot, the rod being coupled to the slider component and the deployment mechanism.

[0145] Clause 28: An inserter described in any one of clauses 1 to 27, further comprising a hollow needle including a bend at an angle of between about 6 degrees and about 10 degrees, the needle being configured to carry an intraocular shunt.

[0146] Clause 29: The inserter of clause 28, wherein the needle defines a straight portion and an angled portion.

[0147] Clause 30: An inserter described in any one of clauses 1 to 29, further comprising a hollow needle extending from a distal end portion of the inserter, the inserter further comprising a deflector component releasably attachable to the distal end portion of the inserter, wherein when the deflector component is coupled to the inserter, the hollow needle extends through the deflector component, and the deflector maintains the needle in a bent configuration.

[0148] Clause 31: The inserter of Clause 30, wherein in the bent configuration, the needle is bent at an angle between about 6 degrees and about 10 degrees.

[0149] Clause 32: The inserter of clause 30, wherein the needle undergoes elastic deformation when coupled with the deflector.

[0150] Clause 33: An inserter as described in Clause 30, wherein the distal end portion of the inserter includes an indexing structure, the deflector component includes an alignment indicator, and the alignment indicator of the deflector component can be releasably engaged with the indexing structure to define the rotational orientation of the deflector component relative to the inserter.

[0151] Clause 34: An inserter as described in clause 33, wherein the deflector component includes a curved needle guide attached to and extending from the coupler, and the alignment indicator is formed along the coupler.

[0152] Clause 35: The inserter of clause 34, wherein the alignment indicator is positioned along a proximal portion of the coupler.

[0153] Clause 36: The inserter of clause 34, wherein the alignment indicator comprises at least one groove extending around the circumference of the coupler.

[0154] Clause 37: The inserter of clause 34, wherein the needle guide comprises a hollow shaft.

[0155] Clause 38: An inserter as described in Clause 33, wherein the indexing structure includes at least one protrusion configured to slide into a corresponding groove.

[0156] Article 39: An intraocular shunt inserter for treating glaucoma, comprising: a housing having a distal portion, a proximal portion, and a longitudinal axis extending between the distal and proximal portions, the housing further including an internal cavity, a guide channel, and an elongated slot extending into the cavity along an outer surface of the housing for actuating a function of the inserter; a slider component coupled to the housing and positioned along an outer surface thereof, the slider component being slidable along the elongated slot, the slider component including a guide tab disposed within the guide channel; an intraocular shunt inserter comprising: a position feedback mechanism including a biased tab and an engagement structure, wherein the biased tab is coupled to a slider part, the engagement structure is formed along an outer surface of the housing, and movement of the slider part causes the biased tab to slide along the engagement structure, generating tactile or auditory feedback to an operator regarding the position of the intraocular shunt relative to the inserter.

[0157] Clause 40: The inserter of clause 39, wherein the engagement structure includes at least one discontinuity in the outer surface of the housing.

[0158] Clause 41: An inserter according to clause 39 or 40, wherein the engagement structure comprises at least one ridge on the outer surface of the housing.

[0159] Clause 42: An inserter according to any one of clauses 39 to 41, wherein the engagement structure comprises a plurality of sawtooth features on the outer surface of the housing.

[0160] Clause 43: An inserter according to any one of clauses 39 to 42, wherein the engagement structure comprises a plurality of tapered peaks on the outer surface of the housing.

[0161] Clause 44: An inserter described in any one of clauses 39 to 43, wherein the function of the inserter includes advancing the shunt within the needle, and the position of the slider part along the engagement structure corresponds to the deployment position of the shunt relative to the needle.

[0162] Clause 45: An inserter described in any one of clauses 39 to 44, wherein the engagement structure includes a plurality of ridges on the outer surface of the housing, each of the ridges corresponding to a deployment position of the intraocular shunt.

[0163] Clause 46: An inserter as described in Clause 45, wherein each of the plurality of protuberances is positioned along the housing at a position corresponding to a rotational position of a drive component of a deployment mechanism of the inserter.

[0164] Clause 47: An inserter described in any one of clauses 39 to 46, further comprising a hollow needle extending from a distal end portion of the inserter, the inserter further comprising a deflector component releasably attachable to the distal end portion of the inserter, wherein when the deflector component is coupled to the inserter, the hollow needle extends through the deflector component and the deflector maintains the needle in a bent configuration.

[0165] Clause 48: The inserter of Clause 47, wherein in the bent configuration, the needle is bent at an angle between about 6 degrees and about 10 degrees.

[0166] Clause 49: The inserter according to clause 47, wherein the needle undergoes elastic deformation when coupled with the deflector.

[0167] Clause 50: An inserter according to clause 52, wherein the needle guide comprises a hollow shaft.

[0168] Clause 51: An inserter as described in Clause 47, wherein the distal end portion of the inserter includes an indexing structure, the deflector component includes an alignment indicator, and the alignment indicator of the deflector component can be releasably engaged with the indexing structure to define the rotational orientation of the deflector component relative to the inserter.

[0169] Clause 52: An inserter as described in Clause 51, wherein the deflector component includes a curved needle guide attached to and extending from the coupler, and the alignment indicator is formed along the coupler.

[0170] Clause 53: An inserter according to Clause 52, wherein the alignment indicator is positioned along a proximal portion of the coupler.

[0171] Clause 54: An inserter as described in Clause 52, wherein the alignment indicator includes at least one groove extending along the circumference of the coupler.

[0172] Clause 55: An inserter as described in Clause 54, wherein the indexing structure includes at least one protrusion configured to slide within the at least one groove.

[0173] Clause 56: The inserter according to clause 47, wherein the needle is elastically deformable.

[0174] Clause 57: A method of operating an intraocular shunt inserter, comprising: advancing a slider component distally along a housing of an intraocular shunt inserter by overcoming frictional resistance between a friction tab of the slider component and the housing, the slider component being slidable to actuate a function of the inserter, the slider component including a guide tab and a friction tab, the guide tab being slidably disposed within and along a guide channel of the housing, the friction tab being movable relative to the guide tab and including a biasing portion configured to press the friction tab against the housing and bring the guide tab into contact with an inner wall of the guide channel, providing frictional resistance between the slider component and the housing; and contacting a plunger engaged with a slider against a shunt disposed within a needle of the inserter to advance the shunt distally within the needle.

[0175] Clause 58: The method of clause 57, further comprising engaging the discontinuity in the housing via a friction tab.

[0176] Clause 59: The method of clause 58, further comprising generating an audible signal by engaging the discontinuities.

[0177] Clause 60: The method of clause 58 or 59, wherein the location of the discontinuity corresponds to the location of the shunt within the lumen of the needle.

[0178] Clause 61: The method of clause 60, wherein the discontinuity comprises a ridge.

[0179] Clause 62: The method of clause 60, wherein the discontinuities include a sawtooth appearance.

[0180] Clause 63: The method of Clause 60, wherein the discontinuity comprises a tapered peak.

[0181] Clause 64: The method of any one of clauses 57 to 63, further comprising bending the needle of the inserter by coupling a deflector component to a distal end portion of the inserter.

[0182] Clause 65: The method of clause 64, wherein bending comprises inserting the needle through a deflector element to bend the needle.

[0183] Clause 66: The method of clause 64, wherein bending comprises bending the needle at an angle between about 6 degrees and about 10 degrees.

[0184] Clause 67: The method of clause 64, wherein the deflector component defines a straight insertion portion and an angled deployment portion.

[0185] Clause 68: The method of clause 64, further comprising aligning the deflector component with the distal end portion of the inserter via an indexing mechanism.

[0186] Clause 69: The method of clause 68, wherein the indexing mechanism includes at least one protrusion on a distal end portion of the inserter.

[0187] Clause 70: The method of any one of clauses 57 to 69, further comprising elastically deforming the needle.

[0188] Clause 71: A system for deploying an intraocular shunt, comprising: an intraocular shunt inserter including a housing having a distal end portion and a needle extending from the distal end portion; a deflector component releasably attachable to a distal end portion of the inserter, the deflector component having a needle guide configured to receive a needle of the inserter therein, the needle guide maintaining the needle in a bent configuration.

[0189] Clause 72: The system of clause 71, wherein the needle guide comprises a hollow shaft.

[0190] Clause 73: The system of clause 71 or 72, wherein in the bent configuration, the needle is bent at an angle between about 6 degrees and about 10 degrees.

[0191] Clause 74: An inserter according to any one of clauses 71 to 73, wherein the needle undergoes elastic deformation when coupled with the deflector part.

[0192] Clause 75: An inserter described in any one of clauses 71 to 74, wherein the distal end portion of the inserter includes an indexing structure, the deflector part includes an alignment indicator, and the alignment indicator of the deflector part can be releasably engaged with the indexing structure to define the rotational orientation of the deflector part relative to the inserter.

[0193] Clause 76: The system described in Clause 75, wherein the deflector component includes a coupler, the needle guide is attached to the coupler, and the alignment indicator is formed along the coupler.

[0194] Clause 77: The system of clause 76, wherein the alignment indicator is positioned along a proximal portion of the coupler.

[0195] Clause 78: The system of clause 76, wherein the alignment indicator comprises at least one groove extending along the circumference of the coupler.

[0196] Clause 79: The system of clause 76, wherein the indexing structure includes at least one protrusion configured to slide within a corresponding groove.

[0197] Clause 80: An intraocular shunt delivery device comprising: a cylindrical housing including guide channels extending longitudinally along the housing, each guide channel defining an inner wall having an upper surface; a semi-cylindrical slider disposed about the housing, the slider being axially movable relative to the housing, the slider comprising: a pair of guide tabs disposed within each of the guide channels of the housing for securing the slider to the housing; a friction tab disposed intermediate the guide tabs on the slider, the biasing portion configured to press the friction tab against the housing and cause the guide tab to contact the inner wall of the guide channel; and a slider comprising a slider protrusion operably coupled to a shunt deployment mechanism within the housing.

[0198] Clause 81: The delivery device of clause 80, wherein the guide channels are positioned at approximately 180 degrees to each other.

[0199] Clause 82: A delivery device according to clause 80 or 81, wherein the slider protrusion passes through the housing to the deployment mechanism.

[0200] Clause 83: A delivery device as described in any one of clauses 80 to 82, wherein the housing includes an engagement structure arranged along the outer surface of the housing by which friction tabs can contact the housing to provide audible or tactile feedback to the operator.

[0201] Clause 84: The delivery device of Clause 83, wherein the engagement structure comprises a groove, a recess, or a protrusion.

[0202] Clause 85: The delivery device of Clause 83, wherein the engagement structure includes at least one discontinuity for receiving the biasing portion.

[0203] Clause 86: The delivery device of Clause 83, wherein the engagement structure includes at least one ridge on an outer surface of the housing.

[0204] Clause 87: The delivery device of clause 83, wherein the engagement structure includes a plurality of sawtooth formations on an outer surface of the housing.

[0205] Clause 88: The delivery device of Clause 83, wherein the engagement structure comprises a plurality of tapered peaks on an outer surface of the housing.

[0206] Clause 89: A delivery device described in any one of clauses 80 to 88, further comprising a hollow needle including a bend at an angle of about 6 degrees to about 10 degrees and configured to hold an intraocular shunt.

[0207] Clause 90: The delivery device of Clause 89, wherein the bend defines a straight insertion portion and an angled deployment portion of the needle.

[0208] The delivery device of clause 89 further includes a deflector component releasably attachable to a distal end portion of the delivery device, wherein when the deflector component is coupled to the delivery device, the hollow needle extends through the deflector component, and the deflector maintains the needle in a bent configuration.

[0209] Clause 92: The delivery device of clause 91, wherein the needle is elastically deformed.

[0210] Clause 93: A delivery device as described in Clause 91, wherein the distal end portion of the delivery device includes an indexing structure, the deflector component includes an alignment index, and the alignment index of the deflector component can be releasably engaged with the indexing structure to define a rotational orientation of the deflector component relative to the delivery device.

[0211] Article 94: An inserter device for deploying an intraocular shunt, the device comprising: Housing and a shunt deployment mechanism disposed within the housing; a deformable hollow needle coupled to a housing and a deployment mechanism for delivering an intraocular shunt; An inserter device comprising: a deflector component releasably attachable to a distal end portion of the housing, the deflector component including a coupling body and a needle guide positionable relative to a portion of the needle, to position the needle in a bent configuration.

[0212] Clause 95: The device described in Clause 94, wherein the needle guide includes a bend at an angle between about 0 degrees and about 15 degrees.

[0213] Clause 96: A device described in clause 94 or 95, wherein the needle guide includes a bend at an angle between about 2 degrees and about 10 degrees.

[0214] Clause 97: A device described in any one of clauses 94 to 96, wherein the needle guide includes a bend at an angle of between about 3 degrees and about 8 degrees.

[0215] Clause 98: A device described in any one of clauses 94 to 97, wherein the needle guide includes a bend at an angle of between about 4 degrees and about 6 degrees.

[0216] Clause 99: A device described in any one of clauses 94 to 98, wherein the needle guide includes a straight insertion portion and an angled deployment portion.

[0217] Clause 100: A device described in any one of clauses 94 to 99, wherein the needle is elastically deformable.

[0218] Clause 101: A device described in any one of clauses 94 to 100, wherein the housing includes an indexing structure, the deflector component includes an alignment index, and the alignment index of the deflector component can be releasably engaged with the indexing structure to define the rotational orientation of the deflector component relative to the inserter device.

[0219] Clause 102: The device of clause 101, wherein the indexing structure includes a plurality of indexing grooves.

[0220] Clause 103: The apparatus described in clause 102, wherein the plurality of indexing grooves are configured to receive a plurality of indexing protrusions of the deflector component.

[0221] Clause 104: The apparatus of clause 101, wherein the indexing structure defines a plurality of orientations in which the deflector component can engage with the housing.

[0222] Clause 105: An apparatus described in any one of clauses 94 to 104, further comprising a slider component described in any one of clauses 1 to 104.

[0223] Clause 106: A method of operating an intraocular shunt inserter, the method comprising: providing an insertion device for deploying an intraocular shunt, the device including a housing having a distal end portion, a shunt deployment mechanism disposed within the housing, and a deformable hollow needle coupled to the housing and the deployment mechanism for delivering the intraocular shunt; inserting the needle into the needle guide of the deflector assembly to position the needle in a bent configuration; and coupling the deflector component to the distal end portion of the housing with a coupling body of the deflector component positioned relative to the distal end portion.

[0224] Clause 107: The method of clause 106, wherein inserting includes bending the needle in the bent configuration at an angle between about 0 degrees and about 15 degrees.

[0225] Clause 108: The method of clause 106 or 107, wherein inserting includes bending the needle in the bent configuration at an angle between about 6 degrees and about 10 degrees.

[0226] Clause 109: The method of any one of clauses 106 to 108, wherein inserting includes bending the needle in a bent configuration at an angle of between about 2 degrees and about 10 degrees.

[0227] Clause 110: The method of any one of clauses 106 to 109, wherein inserting includes bending the needle in a bent configuration at an angle of between about 3 degrees and about 8 degrees.

[0228] Clause 111: The method of any one of clauses 106 to 110, wherein inserting includes bending the needle in a bent configuration at an angle of between about 4 degrees and about 6 degrees.

[0229] Clause 112: The method of any one of clauses 106 to 111, wherein the needle guide comprises a straight insertion portion and an angled deployment portion.

[0230] Clause 113: The method of any one of clauses 106 to 112, further comprising aligning the deflector component with the distal end portion of the inserter via an indexing mechanism.

[0231] Clause 114: The method of clause 113, wherein the indexing mechanism includes at least one protrusion on a distal end portion of the inserter.

[0232] Clause 115: The method of clause 113 or 114, wherein aligning includes rotating and aligning the deflector component relative to the housing.

[0233] Clause 116: The method of clause 115, wherein rotating to align includes selecting an indexed rotational position from a plurality of rotational positions.

[0234] Clause 117: A device incorporating any of the configurations described in any one of clauses 1 to 116.

[0235] Clause 118: A method incorporating any of the configurations described in any one of clauses 1 to 116.

[0236] Other considerations In some embodiments, any of the clauses herein may depend on any one of the independent clauses or any one of the dependent clauses. In an aspect, any of the clauses (e.g., dependent clauses or independent clauses) may be combined with any one or more other clauses (e.g., dependent clauses or independent clauses). In an aspect, a claim may include some or all of the words (e.g., steps, operations, means, or components) listed in a clause, sentence, phrase, or paragraph. In an aspect, a claim may include some or all of the words listed in one or more clauses, sentences, phrases, or paragraphs. In an aspect, some of the words in each clause, sentence, phrase, or paragraph may be deleted. In an aspect, additional words or elements may be added to a clause, sentence, phrase, or paragraph. In an aspect, the subject technology may be practiced without utilizing some of the components, elements, functions, or operations described herein. In an aspect, the subject technology may be practiced using additional components, elements, functions, or operations.

[0237] Reference to an element in the singular is not intended to mean only one, but rather one or more, unless otherwise specified. For example, "a" module can refer to one or more modules. The use of an element preceded by "a," "an," "the," or "said" does not, without further constraint, preclude the presence of additional identical elements.

[0238] Headings and subheadings, if present, are used for convenience only and are not limiting of the invention. Exemplary words are used to mean serving as examples or illustrations. To the extent that terms such as "include," "have," and the like are used, such terms are intended to be inclusive in a manner similar to the term "comprise" as it is interpreted when used as a transitional word in the claims. Relative terms such as first and second may be used to distinguish one entity or operation from another without necessarily requiring or suggesting any actual relationship or order between the entities or operations.

[0239] Phrases such as "one aspect," "an aspect," "another aspect," "some aspects," "one or more aspects," "one implementation," "an implementation," "some implementations," "one or more implementations," "one embodiment," "an embodiment," "some embodiments," "one or more embodiments," "one configuration," "a configuration," "another configuration," "some configurations," "one or more configurations," the subject technology, disclosure, the present disclosure, and other variations thereof are used for convenience and do not imply that the disclosure associated with such phrases is essential to the subject technology or that such disclosure applies to all configurations of the subject technology. The disclosure associated with such phrases may apply to all configurations, or to one or more configurations. The disclosure associated with such phrases may provide one or more examples. Phrases such as "one aspect" or "some aspects" can refer to one or more aspects, and vice versa, and this applies equally to the other aforementioned phrases.

[0240] The phrase "at least one" preceding a list of items, along with the terms "and" or "or" to separate any of the items, modifies the list as a whole, not each member of the list. The phrase "at least one" does not require the selection of at least one item; rather, the phrase allows for a meaning including any one of the items, and / or at least one of any combination of the items, and / or at least one of each of the items. By way of example, the phrases "at least one of A, B, and C" or "at least one of A, B, or C" each refer to A only, B only, or C only, any combination of A, B, and C, and / or at least one of each of A, B, and C.

[0241] It is understood that the specific order or hierarchy of steps, operations, or processes disclosed is an example of a sample approach. Unless otherwise stated, it is understood that the specific order or hierarchy of steps, operations, or processes may be performed in a different order. Some of the steps, operations, or processes may be performed simultaneously. The accompanying method claims, if present, present the various steps, operations, or process elements in a sample order and are not meant to be limited to the specific order or hierarchy presented. These may be performed sequentially, linearly, in parallel, or in a different order. It should be understood that the instructions, operations, and systems described may generally be integrated into a single software / hardware product or packaged into multiple software / hardware products.

[0242] In one aspect, the term coupled or the like can refer to being directly coupled. In another aspect, the term coupled or the like can refer to being indirectly coupled.

[0243] Terms such as top, bottom, front, back, side, horizontal, and vertical refer to any frame of reference, not the usual gravitational frame of reference, and thus such terms can extend upward, downward, diagonally, or horizontally in the gravitational frame of reference.

[0244] This disclosure is provided to enable those skilled in the art to practice the various aspects described herein. In some instances, well-known structures and components are shown in block diagram form to avoid obscuring the concepts of the subject technology. This disclosure provides various examples of the subject technology, and the subject technology is not limited to these examples. Various modifications to these aspects will be readily apparent to those skilled in the art, and the principles described herein may be applied to other aspects.

[0245] All structural and functional equivalents to the elements of the various aspects described throughout this disclosure that are known, or that later become known, to those of ordinary skill in the art are expressly incorporated herein by reference and are intended to be encompassed by the claims. Furthermore, nothing disclosed herein is intended to be dedicated to the public, regardless of whether such disclosure is expressly recited in the claims. No claim element is to be construed under the provisions of the sixth paragraph of 35 U.S.C. § 112 unless the element is expressly recited using the phrase "means for," or, in the case of a method claim, unless the element is recited using the phrase "step for."

[0246] The title, background art, brief description of the drawings, abstract, and drawings are hereby incorporated into this disclosure and are provided as illustrative examples of the disclosure, not as a limiting description. They are submitted with the understanding that they will not be used to limit the scope or meaning of the claims. It will also be appreciated that in the Detailed Description, the description provides illustrative examples, and that various configurations have been grouped together into various implementations for the purpose of streamlining the disclosure. This method of disclosure is not to be interpreted as reflecting an intention that claimed subject matter requires more configurations than are expressly recited in each claim. Rather, as the claims reflect, inventive subject matter lies in less than all configurations of a single disclosed configuration or operation. The claims are hereby incorporated into the Detailed Description, with each claim standing on its own as separately claimed subject matter.

[0247] The claims are not intended to be limited to the embodiments described herein but are to be accorded full scope consistent with the language of the claims and encompass all legal equivalents. Nevertheless, no claim is intended, and should not be interpreted, to cover subject matter that does not comply with applicable patent law requirements.

Claims

[Claim 1] 1. An intraocular shunt inserter for treating glaucoma, comprising: a housing having a distal portion, a proximal portion, and a longitudinal axis extending between the distal portion and the proximal portion, the housing further comprising an internal cavity, a guide channel, and an elongated slot, the guide channel extending along the longitudinal axis and accessible along an outer surface of the housing, the guide channel having an inner wall, and the elongated slot extending along the outer surface of the housing and along the longitudinal axis into the internal cavity; a slider component slidably coupled to the housing along the outer surface of the housing, the slider component slidably coupled to the housing along the elongated slot to actuate a function of the inserter via the elongated slot, the slider component comprising a guide tab and a friction tab, the guide tab being slidably disposed within and along the guide channel of the housing, the friction tab being movable relative to the guide tab and comprising a biasing portion configured to press the friction tab against the housing and to bring the guide tab into contact with the inner wall of the guide channel, and to provide frictional resistance to sliding between the slider component and the housing; An intraocular shunt inserter comprising:

Images