Ocular shunt inserter

Abstract

An inserter can include a housing and a slider component. The slider component can be coupled to the housing and positioned along an outer surface of the housing. The slider component can be slidable along an elongated slot of the housing and include a guide tab disposed within a guide channel of the housing body. The slider can include a friction tab having a biasing member configured to press against the housing 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 a needle of the inserter therein. The deflector component can be removably coupled to the inserter to allow the needle guide to bend the needle and hold the needle in a bent configuration.

Description

[0001] This application is a divisional application of patent application No. 2018800921898, filed on March 9, 2018, entitled "Intraocular Shunt Insertor". Background Technology

[0002] Glaucoma is an eye disease that affects millions of people. Glaucoma is associated with increased intraocular pressure caused by the eye's drainage system's inability to adequately remove aqueous humor from the anterior chamber or by the ciliary body producing too much aqueous humor. The buildup of aqueous humor and the resulting increased intraocular pressure can lead to irreversible damage to the optic nerve and retina, potentially resulting in irreversible retinal damage and blindness.

[0003] Glaucoma can be treated in many different ways. One treatment involves delivering medications such as beta-blockers or prostaglandins to the eye to reduce the production of aqueous humor or increase its outflow from the anterior chamber. Glaucoma filtration surgery is a common surgical procedure used to treat glaucoma. This surgery involves placing a shunt in the eye to relieve intraocular pressure by creating a pathway for the aqueous humor to drain from the anterior chamber. The shunt is typically positioned in the eye so that it creates a drainage path between the anterior chamber and the low-pressure area. Such a fluid flow path allows the aqueous humor to leave the anterior chamber. Summary of the Invention

[0004] The importance of lowering intraocular pressure (IOP) in slowing the progression of glaucoma has been well-established. Surgical intervention is approved when drug therapy fails or is not tolerated. Several surgical filtration methods exist to lower IOP by creating a fluid flow pathway between the anterior chamber and subconjunctival tissue. In one particular method, an intraocular shunt is implanted using an inserter guided by a needle that holds the shunt across the cornea, through the anterior chamber, across the trabecular meshwork and sclera, and into the subconjunctival space. See, for example, U.S. Patent No. 6,544,249, U.S. Patent Application Publication No. 2008 / 0108933, and U.S. Patent No. 6,007,511, the entire contents of which are incorporated herein by reference.

[0005] Existing inserters may have components that can move unexpectedly and may not consistently provide the required 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 perform manual and / or visual inspection steps, which increases the time a careful and meticulous operator must spend on each step of the procedure. Thus, this increases the procedure time, potentially causing greater trauma to the patient, and still relies on tactile or visual perception of the parts without certainty that certain events or positions have been achieved.

[0006] Therefore, this disclosure takes into account these problems, provides solutions to these problems, and relates to certain advantageous features in a shunt inserter that enable improved accuracy while reducing operator effort and surgical time in some embodiments.

[0007] Some embodiments disclosed herein provide an intraocular shunt inserter with an actuator that allows an operator to deliver and / or release an intraocular shunt. The inserter may be configured to provide a frictional track or resistance that the operator can overcome to slide or rotate the actuator. This resistance to movement ensures that the inserter is exposed or released only when the operator intends to. Furthermore, this resistance may predispose the operator to operate the inserter with greater precision and control.

[0008] Optionally, some embodiments may include one or more feedback components that can serve as indicators of the completion of movement or steps during the surgical procedure. For example, the inserter may include actuators, whether sliding or rotating, that provide one or more audible clicking sounds and / or barriers of increased resistance to signal to the operator that a certain position or step of the surgical procedure has been completed. In some embodiments, the slider component may contact a first engagement structure or indicator on the inserter to produce an audible clicking sound or barrier of increased resistance. Continued movement beyond the clicking sound or barrier of increased resistance enables the operator to move the slider component toward a second, third, fourth, or other engagement structure or indicator, which may produce a clicking sound or barrier of increased resistance to signal to the operator that the slider component has advanced to a predetermined position and / or that other positions or steps of the surgical procedure have been completed. Thus, the inserter can advantageously provide the operator with improved accuracy and feedback.

[0009] Furthermore, some embodiments disclosed herein may optionally provide an inserter with a curved shaft or needle, which provides greater tactile control of the inserter and improves clearance during surgery. The needle may extend from the distal end of the inserter and include a bend where the longitudinal axis of the needle is reoriented along a different axis. The bend makes it easier for the operator to manipulate and / or perceive the position of the bevel of the needle during surgery. Therefore, some embodiments advantageously allow the operator to more easily visually verify that certain results have been achieved. For example, by rotating the bevel of the needle, the operator can “bulge” the conjunctiva, thereby facilitating the placement and delivery of the intraocular shunt to the subconjunctival target location. Furthermore, compared to a straight needle inserter, the bend during surgery allows for a greater distance between the longitudinal axis of the inserter housing and the patient's face.

[0010] For example, the inserter may include a housing and a slider component. The housing includes a distal end, a proximal end, a longitudinal axis extending between the distal and proximal ends, an internal chamber, and an elongated slot extending along an outer surface of the housing into the chamber. The slider component may be coupled to the housing and positioned along the outer surface of the housing. The slider component may slide along the elongated slot to operate the inserter. The slider component may include a guide plate disposed within a guide channel of the housing body. The slider component may also include a friction plate having a biasing member configured to press against the housing body to press the guide plate against the channel wall of the guide channel.

[0011] The operator operates the inserter by pushing the slider assembly along its axis. The slider assembly actuates the inserter's deployment mechanism to deliver and release the intraocular shunt. To do this, the operator must overcome the initial frictional force relative to the housing provided by the friction plates of the slider assembly. The operator can use the slider assembly to advance the inserter's plunger, pushing the shunt into the lumen of the needle.

[0012] During the operation of the inserter, for example, as the friction pad moves across the engagement structure, the operator can receive tactile or unpleasant feedback from the engagement structure of the housing. This feedback can correspond to the position of the shunt relative to the needle within the inserter. Feedback can be provided through discontinuities on the housing.

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

[0014] The accompanying drawings provide a further understanding of the subject matter and are incorporated in and form part of this specification. The drawings illustrate various aspects of this disclosure and, together with the specification, serve to explain the principles of the subject matter.

[0015] Figure 1A This is a schematic diagram of a surgical procedure for implanting an intraocular shunt into the eye using an inserter, according to some embodiments.

[0016] Figure 1B This is a perspective view of an inserter for implanting an intraocular shunt into the eye, according to some embodiments.

[0017] Figure 2 According to some embodiments Figure 1B An exploded perspective view of the inserter shown.

[0018] Figure 3 According to some embodiments Figure 1B The exploded perspective view of the inserter's driving component shown.

[0019] Figures 4A to 4C Illustrations are shown according to some embodiments Figure 1B The slider component of the inserter shown.

[0020] Figure 5 This is a cross-sectional view of an inserter for implanting an intraocular shunt into the eye, according to some embodiments.

[0021] Figures 6A to 6C This is a cross-sectional view of the engagement structure of the inserter according to some embodiments.

[0022] Figure 7A According to some embodiments Figure 3 A perspective view of the sleeve fixing component with a straight axis drive assembly shown.

[0023] Figure 7B According to some embodiments Figure 3 A perspective view of the sleeve fastener of the drive assembly with a bending shaft shown.

[0024] Figure 8A This is a perspective view of an inserter having a curved alignment guide for providing a bend in the axis of the inserter, according to some embodiments.

[0025] Figure 8B This is a perspective view of an alignment guide attached to a sleeve according to some embodiments.

[0026] Figure 8C This is a side view of an alignment guide attached to a sleeve according to some embodiments.

[0027] Figure 9A This is a front perspective view of another alignment guide according to some embodiments.

[0028] Figure 9B According to some embodiments Figure 9A Rear perspective view of the alignment guide.

[0029] Figure 10A This is a perspective view of an alignment guide attached to a sleeve with a protective cap, according to some embodiments.

[0030] Figure 10B This is a side sectional view of a beveled protective device housed within the needle cavity of an inserter, according to some embodiments. Detailed Implementation

[0031] In the detailed description below, numerous specific details are set forth to provide a comprehensive understanding of the subject matter. It should be understood that the subject matter can 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 matter.

[0032] Glaucoma is a disease that damages the optic nerve, leading to progressive and irreversible vision loss. Glaucoma is usually associated with increased pressure in the fluid within the eye (i.e., the aqueous humor). Untreated glaucoma can cause permanent damage to the optic nerve and consequently visual field loss, which can progress to blindness. Once lost, the damaged visual field cannot be restored.

[0033] In glaucoma, the pressure of the aqueous humor in the anterior chamber of the eye increases, and this increased pressure can damage the vascular system at the back of the eye, particularly the optic nerve. Treatment for glaucoma and other conditions that cause increased pressure in the anterior chamber involves reducing the pressure in the anterior chamber to normal levels.

[0034] Glaucoma filtration surgery is a surgical procedure commonly used to treat glaucoma. This procedure involves placing a shunt in the eye to reduce intraocular pressure by creating a pathway for aqueous humor to drain from the anterior chamber. The shunt is typically positioned in the eye such that it creates a drainage path between the anterior chamber and the low-pressure area. Various structures and / or areas of the eye with low pressure that facilitate aqueous humor drainage include the scleral venous sinus, subconjunctival space, external scleral vein, suprachoroidal space, intra-Tenon's adhesion space, and subarachnoid space. The shunt can be implanted using an external approach (e.g., through the conjunctiva and into the sclera) or an internal approach (e.g., through the cornea, across the anterior chamber, through the trabecular meshwork, and through the sclera). For example, Yu et al. (U.S. Patent No. 6,544,249 and U.S. Patent Application Publication No. 2008 / 0108933) and Prywes (U.S. Patent No. 6,007,511) have described an internal approach method for implanting an intraocular shunt in the subconjunctival space, the entire contents of which are incorporated herein by reference.

[0035] Some methods may involve inserting a hollow shaft configured to hold an intraocular shunt into the eye. In some embodiments, the hollow shaft may be a component of a deployment device that can deploy the intraocular shunt. The hollow shaft may be coupled to a deployment device or may be part of the deployment device itself. The deployment device may include means such as those described in commonly owned U.S. Patent Nos. 9,585,790, 8,721,792, 8,852,136, and U.S. Patent Application Publication No. 2012 / 0123434, filed November 15, 2010, the entire contents of which are incorporated herein by reference.

[0036] As mentioned above, conventional deployment devices or inserters may not provide the desired level of accuracy and feedback, and require additional operator effort and surgical time. This disclosure provides various embodiments of methods and apparatus that enable operators to implant shunts using inserters while improving comfort, feedback, and accuracy, thus reducing surgical time. As used herein, the term "shunt" includes hollow micro-fistulas similar to the type generally described in U.S. Patent No. 6,544,249, and other structures including one or more lumens or other flow paths therethrough.

[0037] According to some embodiments, the inserter can be entered into the eye via an internal or external approach. Thereafter, a shunt can be inserted into the eye from the shaft, creating a channel from the anterior chamber to a low-pressure region, such as the scleral venous sinus, subconjunctival space, external scleral vein, suprachoroidal space, Nettenon's adhesion space, subarachnoid space, or other regions of the eye. The hollow shaft is then withdrawn from the eye. Methods for delivering and implanting bioresorbable or permanent tubes or shunts, and implantation devices for performing these methods, are generally disclosed in the applicant’s applications, including: U.S. Patent Application Publications Nos. 2012 / 0197175, 2015 / 0011926 and 2016 / 0354244, U.S. Patent Application No. 15 / 613,018, and U.S. Patent Nos. 6,007,511, 6,544,249, 8,852,136 and 9,585,790, each of which is incorporated herein by reference in its entirety.

[0038] Some methods involve making an incision in the eye before inserting the deployment device. However, in some cases, this 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 tip or end. In some embodiments, the hollow shaft is a needle. Exemplary needles that can be used are commercially available from Terumo Medical Corp. (Elkington, MD). In some embodiments, the needle may have a hollow interior and a beveled end, and the intraocular shunt can be held within the hollow interior of the needle. In some embodiments, the needle may have a hollow interior and a triple grounding point or end.

[0039] Some methods can be performed without removing 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 causing serious ocular inflammation, such as subconjunctival blistering or endophthalmitis. Some methods can be achieved using an internal approach: by inserting a hollow shaft constructed to hold an intraocular shunt through the cornea, across the anterior chamber, through the trabecular meshwork, and into the sclera or the space of inner Tenon's synechiae. However, some methods can also be performed using an external approach.

[0040] In some methods using the internal approach, the angle of entry through the cornea can be varied to affect the optimal placement of the shunt within the Nettennon adhesion space. Compared to entry through the limbus, the hollow shaft can be inserted into the eye at an angle above or below the limbus. For example, the hollow shaft can be inserted at approximately 0.25 mm to approximately 3.0 mm above the limbus. The shaft can be inserted at approximately 0.5 mm to approximately 2.5 mm above the limbus. The shaft can also be inserted at approximately 1.0 mm to approximately 2.0 mm above the limbus, or at any specific value within any of these ranges. For example, the hollow shaft can be inserted at distances of 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.

[0041] Furthermore, in some embodiments, as provided by an entry angle above the limbus, placing the shunt at an exit location farther from the limbus provides more lymphatic pathways (e.g., the suprascleral lymphatic network in addition to the conjunctival lymphatic system) for the drainage of aqueous humor. A larger entry angle also results in a flatter placement within the Nettennon adhesion space, thus reducing the bending of the shunt.

[0042] As discussed in U.S. Patent No. 8,852,136 (the entire contents of which are incorporated herein by reference), in some embodiments, the depth of puncture into the Nettennon adhesion space may be important when performing certain methods to ensure proper positioning and function of the intraocular shunt.

[0043] In some methods, the distal end of the hollow shaft can pierce the sclera and Nettenon's adhesion space without puncturing, removing, or deforming the major tissues of the surrounding eye. A shunt is then deployed from the shaft. Preferably, the distal end of the hollow shaft (opposite to the distal end) is fully inserted into the Nettenon's adhesion space before the shunt is deployed from the hollow shaft.

[0044] According to some embodiments, the hollow shaft may include a flat, beveled needle, such as a needle with triple grounding points. The distal bevel can first pierce the sclera by forming a horizontal incision, and then enter the Nettenong adhesion space. In some methods, the needle may even advance further so that the entire flat bevel penetrates the Nettenong adhesion space, thereby causing the tissue to unfold and open to a full circular diameter.

[0045] Furthermore, according to one aspect of some methods, the Ninternon channel can be opened by pushing the flat, beveled portion of the needle, allowing the material around the opening to fully expand and preventing the shunt tube from being squeezed in that area, thus preventing the shunt from failing due to compression or contraction. The flat, beveled portion fully entering the Ninternon adhesion space may cause minor deformation and trauma in a localized area. However, once the shunt is deployed into the eye, this area will eventually surround and conform to the shunt.

[0046] In some embodiments, the inserter can be used as a one-handed device to allow the operator to hold their other hand on the fixation device (e.g., a hook) that holds the eye in place. This improves surgical control and placement accuracy and makes the procedure easier.

[0047] exist Figure 1A The image shows a diagram of the surgical procedure used to treat eye 12. Figure 1A The use of the hook 14 for holding the eye 12 and the inserter 100 for introducing the intraocular shunt into the eye is shown.

[0048] Figure 1B Figure 9 shows Figure 1A Further details of the inserter 100 are shown. The inserter 100 can be operated with one hand, thus facilitating use by an operator. The inserter 100 may include a housing 102, a needle assembly 104, and a slider component 106. Figure 1B As shown, the inserter 100 can be configured such that the slider component 106 is coupled to the housing 102 via the guide channel 111 and the slider component 106 can slide along the elongated slot 110 of the housing 102. The slider component 106 can be selectively moved by the operator to actuate the movement of components of the needle assembly 104.

[0049] For example, as the slider component 106 moves distally along the slot 110 (i.e., in the direction toward the needle assembly 104), the slider component 106 may cause or result in the advance of a diverter (not shown) into the needle assembly 104, and in some embodiments may cause or result in the release of the diverter from the needle assembly 104. According to some embodiments further discussed herein, movement of the slider component 106 may cause translational and / or rotational movement of components of the needle assembly 104. Sliding movement of the slider component 106 may be converted into rotational movement, which can subsequently be converted into movement along the longitudinal axis of the inserter 100. One benefit of this innovative and sophisticated movement conversion mechanism is that it allows embodiments of the inserter to provide precisely measurable movement of its components within a compact assembly.

[0050] like Figure 2 As shown, the needle assembly 104 may include a needle component 120, a plunger 122, and a cannula component 124. The needle component 120 may include a 25GA needle or a 27GA needle. The plunger 122 is slidably movable within the lumen of the needle component 120 along the longitudinal axis 178 of the inserter 100. Furthermore, the needle component 120 is slidably movable within the lumen of the cannula 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. When assembled, the inserter 100 may be configured such that the needle component 120, the plunger 122, and the cannula component 124 are aligned or coaxial with the longitudinal axis 178. Some drive components for actuating the plunger and for withdrawing the needle of the inserter are disclosed in U.S. Patent Applications Nos. 13 / 336,803, 12 / 946,645, 12 / 620,564, 12 / 946,653, 12 / 946,565, 12 / 946,565, and 11 / 771,805 and U.S. Patent No. 9,585,790, the entire contents of which are incorporated herein by reference.

[0051] refer to Figure 2 and Figure 3 The needle component 120, plunger 122, and cannula component 124 can be operatively coupled to the drive assembly 130 and / or the housing 102. For example, the needle component 120 can be coupled to the needle retainer 140. The needle retainer 140 can be securely coupled to the proximal end of the needle component 120, thereby limiting or preventing rotational and longitudinal movement between the needle component 120 and the needle retainer 140. When the inserter 100 is assembled, the needle retainer 140 can be enclosed within the distal end of the housing 102. Furthermore, as in... Figure 3 As shown and further discussed below, the needle retainer 140 can be coupled to the needle driver 164 of the drive assembly 130 (and in the illustrated embodiment, via the rotation adjustment member 300).

[0052] In addition, such as Figure 3 As shown, plunger 122 can be coupled to plunger retainer 142. Plunger retainer 142 can be fixedly coupled to the proximal or middle section of plunger 122 to restrict or prevent rotational and longitudinal movement of plunger 122 relative to plunger retainer 142. Furthermore, as... Figure 3 As shown in the diagram and discussed further below, the plunger retainer 142 can be coupled to the plunger driver 162 of the drive assembly 130.

[0053] Furthermore, the sleeve component 124 may be coupled to the sleeve retainer 144. The sleeve retainer 144 may be coupled to the proximal end of the sleeve component 124 to prevent rotational and longitudinal movement between the sleeve component 124 and the sleeve retainer 144. As discussed below, the sleeve retainer 144 may be coupled to a portion 148 of the housing 102.

[0054] As described above, the needle component 120, plunger 122, and cannula component 124 are operatively coupled to the drive assembly 130 and / or the housing 102. Such coupling can be achieved via the needle retainer 140, plunger retainer 142, and cannula retainer 144. Subsequently, the needle retainer 140, plunger retainer 142, and cannula retainer 144 can be coupled to one or more drive components, which engage with the drive assembly 134 in the housing 102.

[0055] According to some embodiments, the drive assembly 130 may be coupled to the needle component 120 and the plunger 122 to actuate movement of the needle component 120 and the plunger 122 relative to the housing 102 along the longitudinal axis 178. For example, the drive assembly 130 may be configured to rotate or slide within the housing 102. The drive assembly 130 may transmit longitudinal or axial forces independently or simultaneously to the needle component 120 and / or the plunger 122 along the longitudinal axis 178 to cause movement of the needle component 120 and the plunger 122 relative to the housing 102 along the longitudinal axis 178.

[0056] As discussed herein, movement of the slider component 106 can cause movement of the drive assembly 130, and thus cause movement of components of the drive assembly 130 relative to the housing 102. Some embodiments may be configured such that the slider component 106 can move or slide longitudinally relative to the housing 102 along the longitudinal axis 178 to drive or cause linear movement of the needle component 120 and the plunger 122, and thereby drive or cause linear movement of the diverter.

[0057] like Figure 3As shown, the drive assembly 130 may include a drive member 160, a plunger driver 162, and a needle driver 164. In some embodiments, longitudinal or linear movement of the slider member 106 along the longitudinal axis 178 may be converted into rotation of the drive member 160 of the drive assembly 130, which may then be converted into longitudinal or linear movement of the needle member 120 and the plunger 122 relative to the housing 102 along the longitudinal axis 178. According to some embodiments, the movement of the members along the longitudinal axis 178 may be parallel to the longitudinal axis 178.

[0058] Figure 3 An embodiment of the drive component 160 is also shown. The drive component 160 may include a groove 170 configured to engage with a corresponding protrusion (not shown) of the slider component 106. Furthermore, the drive component 160 may also include a first drive groove 172 and a second drive groove 174 configured to slidably engage with corresponding protrusions of the plunger driver 162 and the needle driver 164. Therefore, the slider component 106 may include a protrusion 430 (in...) Figure 4B As shown in the diagram, plunger actuator 162 may include a protrusion 182, and needle actuator 164 may include a protrusion 184. This arrangement of slots and protrusions facilitates the transmission of motion from slider component 106 to the corresponding one of needle component 120 and plunger 122. Furthermore, plunger actuator 162 and needle actuator 164 may include rounded bodies that, when falling into drive component 160, contact and slide against the internal guide surface 198 of drive component 160.

[0059] Figures 4A to 4C Illustrations are shown according to some embodiments Figure 1B The slider component 106 of the inserter 100 shown. Figure 4A A perspective view of slider component 106 is shown. Slider component 106 may include a slider body 402 having a proximal end portion 406 and a distal end portion 404. Slider body 402 may have a generally semi-cylindrical shape. The proximal end portion 406 and the distal end portion 404 may include a raised proximal boundary or edge 407 and a raised distal boundary or edge 405, the edges 405 and 407 projecting radially from slider component 106 to provide a safe, ergonomic grip for the operator's thumb or fingers during use.

[0060] The slider component 106 may include one or more guide tabs 410. Guide tabs 410 may be disposed at the distal end 404 and the proximal end 406. For example, guide tabs 410 may extend inward toward an inner region 412 of the slider component 106. The inner region 412 of the slider component 106 may include a generally semi-cylindrical shape or cavity configured to be coupled to the inserter 100, for example, by receiving a portion therein. When coupled to the inserter 100, guide tabs 410 may be disposed within a guide channel 111 of the housing 102 to engage the slider component 106 to the housing 102. Thus, as described herein, the guide tabs 410 of the slider component 106 may be retained within the guide channel 111, thereby limiting radial movement of the slider component 106 relative to the housing 102 while allowing axial or longitudinal movement of the slider component 106 along the housing 102.

[0061] Optionally, the slider component 106 may be configured to include a plurality of guide tabs 410 that extend radially inward from opposite faces or edges of the slider component 106 into an inner region 412. For example, as Figure 4B As shown, the slider component 106 may include a pair of guide tabs 410 extending radially inward from the inner edge 414 of the slider component 106. The guide tabs 410 may be spaced apart from each other at approximately 90 degrees to approximately 180 degrees along the inner edge 414 or the inner surface of the inner region 412.

[0062] Furthermore, in some embodiments, the guide tab 410 may be beveled to allow the slider component 106 to be pressed or snapped onto the housing 102 and into the guide channel 111. For example, one or more guide tabs 410 may include beveled portions facing away from the inner region 412. Thus, when the slider component 106 is pressed against the housing 102, the slider component 106 may slightly deflect to open the inner region 412 until the guide tab 410 snaps into place in the guide channel 111.

[0063] Figure 4B A bottom view of the slider component 106 is shown. (Refer to...) Figure 4BThe protrusion 430 may be integrally formed with the body 402 of the slider component 106. However, according to some embodiments, the protrusion 430 may also be formed as a separate component, which is subsequently attached to the body 402 of the slider component 106. As described herein, movement of the slider component 106 may be transmitted to the drive assembly 130 via the protrusion 430, thereby causing movement of components of the drive assembly 130 relative to the housing 102. In some embodiments, the protrusion 430 may be located at the proximal end portion 406 of the slider component 106. In some embodiments, the protrusion 430 may be located at the distal end portion 404 of the slider component. In some embodiments, the protrusion 430 may be located between the proximal end portion 406 and the distal end portion 404.

[0064] Figure 4C A top view of slider component 106 is shown. (Refer to...) Figure 4B and Figure 4C The friction plate 420 may be integrally formed with the body 402 of the slider component 106. As used herein, "integrally formed" can be defined as being formed as a single continuous component or workpiece. Such a component may be injection molded as a single continuous component, or it may be started as a single component and subsequently machined or otherwise processed to produce various features joined together by a single continuous material. For example, the friction plate 420 may be formed by forming a slot 422, which defines the shape of the friction plate 420 and allows the friction plate 420 to move relative to the body 402, for example, by a cantilever connection or via a pivot or attachment point 424. The attachment point 424 may be reinforced or include additional body material to improve cyclic fatigue strength. In some embodiments, the friction plate 420 may be formed as a separate component that is subsequently attached to the body 402 of the slider component 106.

[0065] like Figure 4B As shown, the friction plate 420 may include a biasing member or friction protrusion 426 that extends radially beyond the adjacent portion of the body 402. The protrusion 426 may extend radially inward toward or into the inner region 412. The protrusion 426 may be tapered or beveled to allow the slider component 106 to travel in one direction over one or more engagement structures (e.g., notches, serrations, slots, protrusions, or bumps) of the housing 102, and to impede the slider component 106 in the opposite direction.

[0066] For example, protrusion 426 may include a deflection-promoting distal surface that extends at an obtuse angle relative to the inner surface of slider member 106 and faces the distal boundary or edge 405. Thus, in some embodiments, friction pad 420 may move or deflect relative to the body of slider member 106, and the distal surface of protrusion 426 allows protrusion 426 to begin radial deflection as it slides axially on the engagement structure formed on housing 102. Figure 6A This configuration is shown in the side view. Therefore, the distal surface of the protrusion 426 can be configured to allow or facilitate the distal movement of the slider component 106 along the housing 102.

[0067] Furthermore, the protrusion 426 may include an anti-reverse proximal surface that extends perpendicularly to or at an angle (e.g., an acute angle if it is a protrusion, or an obtuse angle if it is a notch) relative to the inner surface of the slider member 106 and faces the proximal boundary or edge 407. Thus, the proximal surface of the protrusion 426 may be configured to intercept or restrict the proximal movement of the slider member 106 along the housing 102.

[0068] In some embodiments, the engagement structure of the housing 102 may include a deflection-enhancing cross-sectional profile, such as a rounded or angled shape (e.g., an obtuse angle extending from the outer surface 440 of the housing 102), along the proximal face of the engagement structure, which initially contacts the protrusion 426 as the slider member 106 is advanced distally along the housing 102. Furthermore, in some embodiments, both the proximal and distal faces of the engagement structure may include a deflection-enhancing cross-sectional profile.

[0069] Optionally, the engagement structure of the housing may include an anti-reverse cross-sectional profile. For example, the engagement structure may include an edge extending perpendicularly from the outer surface 440 of the housing 102 or at an angle (e.g., an obtuse angle if it is a protrusion, or an acute angle if it is a notch). In some embodiments, the distal face of the engagement structure may include an anti-reverse cross-sectional profile. Thus, the distal face of the engagement structure may hook or engage with the proximal surface of the protrusion 426 to restrict movement of the slider component 106 along the proximal end of the housing 102. Additionally, in some embodiments, the proximal face of the engagement structure may include a deflection-enhancing cross-sectional profile, and the distal face of the engagement structure may include an anti-reverse cross-sectional profile.

[0070] Optionally, as further described herein, the protrusion 426 and / or engagement structure may be shaped to provide auditory and / or tactile feedback to the operator. As those skilled in the art will understand, a snapping or clicking sound can be produced by deflecting the friction pad 420 and rapidly allowing it to release into contact with the outer surface 440 of the housing 102. This can be achieved in various ways, including when the engagement structure includes a vertical portion that allows rapid radial movement of the protrusion 426 of the friction pad 420 to contact the outer surface 440 of the housing 102. For example, the distal facing portion of the engagement structure may extend perpendicularly relative to the outer surface 440 of the housing 102, such that distal advancement of the slider component 106 on the engagement structure allows the protrusion 426 to engage radially inwardly with the outer surface 440 of the housing 102, thereby providing auditory and / or tactile feedback to the operator.

[0071] Reference Figure 5 An embodiment of the inserter 100 is shown, wherein the slider component 106 is attached to the housing 102 by engaging the guide tab 410 within the guide channel 111. In some embodiments, the guide channels 111 are disposed on opposite sides of the housing 102. For example, the guide tabs 410 and / or the guide channels 111 may be oriented at different angular positions along the slider component 106 and / or the housing 102, such as being 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.

[0072] When the slider component 106 engages in the guide channel 111, the protrusion 426 may contact portions of the housing 102. For example, the protrusion 426 may contact portions of the housing 102 adjacent to the slot 110. In some embodiments, the protrusion 426 may be positioned to contact the housing 102 on opposite sides of the slot 110.

[0073] The protrusion 426 can be biased to contact the housing 102. In some embodiments, the protrusion 426 may contact the housing 102, for example, by deforming along the length of the friction piece 420 or at the attachment point 424, and cause the friction piece 420 to be radially pushed or deflected away from the housing 102. In some embodiments, the body of the friction piece 420 and / or the attachment point 424 are able to resist such deflection or deformation, providing a reaction force against the housing 102 via the friction piece 420 and the protrusion 426. In some embodiments, the attachment point 424 and the friction piece 420 may be biased to provide a biasing force. This biasing force can radially push the slider component 106 away from the housing 102, thereby pressing the guide piece 410 of the slider component 106 against the interior of the guide channel 111. Thus, although the guide protrusion 410 restricts the radially outward movement of the slider component 106 relative to the housing 102, the biasing force applied via the friction protrusion 420 can increase the friction between the slider component 106 and the housing 102. Therefore, in some embodiments, unless sufficient axial force is applied to the slider component 106 to overcome the friction of the slider component 106 on the housing 102, the slider component 106 can tend to remain stationary along the housing 102.

[0074] For example, such as Figure 5 As shown, when the slider component 106 is radially pushed away from the housing 102, the guide plate 410 moves toward the channel wall 111a of the guide channel 111. Therefore, in the stationary state, the slider component 106 is frictionally held between the guide plate 410 and the channel wall 111a, and the protrusion 426 of the friction plate 420 abuts against the outer surface of the housing 102. Advantageously, this arrangement also minimizes the radial clearance within the slider component 106 relative to the housing 102.

[0075] Furthermore, by engaging the friction plate 420 and the guide plate 410 on the housing 102, the friction between the slider component 106 and the housing 102 is enhanced. This enables the slider component 106 to be held in the desired or initial position and prevents accidental movement of the slider component 106 during transport and handling of the inserter 100. Therefore, in order to move the slider component 106 and thereby operate the inserter, an intentional axial force must be applied by the operator to overcome the friction between the slider component 106 and the housing 102.

[0076] Reference Figure 6AThe friction pad 420 can further provide tactile and auditory 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 pad 420, and more specifically, the friction protrusion 426, can traverse the engagement structures 103 formed on the housing 102. Each engagement structure 103 may include discontinuities in the outer surface 440 of the housing 102, such as notches, serrations, slots, protrusions, or bumps. The engagement structures 103 may be identified to reflect different operational stages of the inserter 100 or the position of the slider component 106 along the housing 102 or the slot 110. The housing 102 may be configured to include one or more engagement structures 103. Furthermore, the engagement structures may be combined together (as a single group or multiple groups) or spaced apart along the housing 102.

[0077] For example, such as Figures 6A to 6C As shown, engagement structure 103 can be configured such that when slider component 106 is moved away from its initial position, friction pad 420 contacts a first engagement structure 103a in housing 102 (although shown as a group of three first engagement structures 103a, the first engagement structure 103a may also comprise only a single engagement structure 103 or two engagement structures 103). Similarly, just before slider component 106 reaches a certain position in its entire travel path (e.g., along the middle of the travel path, or after the shunt inserter exposes the shunt in the eye and just before the slider begins to retract the inserter needle back into the housing to continue advancing), friction pad 420 may contact a second engagement structure 103b (although shown as a group of three engagement structures 103, the second engagement structure 103b may also comprise only a single engagement structure 103 or two engagement structures 103). Finally, when the slider component 106 has advanced sufficiently to release the diverter, the friction plate 420 can engage with the third engagement structure 103c (although shown as a group of three engagement structures 103, the third engagement structure 103c may also comprise a single engagement structure 103 or two engagement structures 103). This feedback can be used to signal that the inserter 100 is performing a different operation, the diverter or a portion of the inserter 100 has reached a certain position, and / or that the different operation may require a different driving force.

[0078] Therefore, the slider component 106 can move along the housing 102 and provide the operator with tactile and / or auditory feedback regarding the position of the slider component 106 relative to the housing 102 and / or the position of the shunt or the delivery phase of the shunt. In some embodiments, it may be advantageous to provide feedback to the operator when the shunt is initially exposed from the needle of the inserter. Furthermore, it is also advantageous to provide feedback to the operator when the inserter releases the shunt (the shunt may not yet be fully exposed outside the needle).

[0079] The type, frequency, and / or intensity of the tactile and / or auditory signals may vary depending on the slider component 106, the position of the splitter, and / or the state of the splitter's delivery.

[0080] Tactile or auditory signals may be provided only when certain events are achieved, such as the initial movement of the slider component, the initial exposure of the shunt, the position before the shunt is fully released (e.g., when the cannula has retracted halfway from its fully extended position), and / or the final position of the slider component when the shunt is fully released and the needle is fully retracted (or other such positions as described in U.S. Patent No. 9,585,790, the entire contents of which are incorporated herein by reference). Furthermore, embodiments may be provided in which tactile feedback is provided only at certain events, while auditory feedback is provided at others. For example, one of the tactile or auditory feedback may be provided at the beginning stage, and the other at a later stage of the procedure. Additionally, one of the tactile and auditory feedback may be provided at the beginning and end to mark the initial and final movement of the slider component, while the other is provided when the shunt is initially exposed and before the shunt is fully released. Various options and arrangements described above may be provided.

[0081] Optionally, the housing 102 may include a plurality of engagement structures 103 that provide the operator with continuous and moderate tactile or auditory feedback to indicate that the slider component 106 is moving forward.

[0082] Therefore, according to some embodiments, the shape of the engagement structure 103 may vary along the length of the housing 102 to provide the type, frequency and / or intensity of tactile or auditory feedback, and / or increase the degree of resistance to the force required by the operator to move the slider component.

[0083] For example, regarding the level of resistance provided by the engagement structure 103, in some embodiments, the engagement structure 103 may be configured to require the operator to overcome a subsequently higher level of resistance as the diverter is exposed and eventually released from the inserter. Therefore, the dimensions of the engagement structure 103 (e.g., height or axial length) may increase in the distal direction, thereby increasing the level of resistance to the sliding component as it advances distally.

[0084] The engagement structure 103 may define at least one notch, serrated portion, slot, protrusion, bump, or other modified surface to provide tactile and / or auditory signals or feedback to the user. (See reference...) Figures 6A to 6C This illustrates various features of the joining structure 103. For example... Figure 6AAs shown, the engagement structure 103 may include one or more notches, serrated portions, slots, protrusions, or bumps having an external or cross-sectional profile 502, which may include deflection-promoting surfaces and / or anti-reverse surfaces. The radius 504 and spacing 506 of the engagement structure 103 may be varied. In particular, the radius 504 of the engagement structure 103 may be varied to provide stronger feedback or resistance to movement of the slider component 106.

[0085] like Figure 6B As shown, the engagement structure 103 may include a vertical, distally facing surface 505 that provides a significant drop from the end or height of the engagement structure 103. In some embodiments, surface 505 is capable of providing an auditory function when the friction pad 420 is allowed to ride on the profile 502 on the front or proximal side, and then the friction pad 420 bounces down or radially inward, snaps, or clicks inward against the housing 102 to provide auditory and / or tactile signals.

[0086] According to some embodiments, the radius or angle of the contour 502 or the height of the engagement structure 103 can be modified to provide different sound or tactile signals, or to increase the sliding resistance of the slider component 106 as it crosses the engagement structure 103.

[0087] Alternatively, when the engagement structures 103 are grouped together, the spacing between the engagement structures 103 can be changed to alter the frequency of the auditory signal from the auditory mechanism of the friction plate 420.

[0088] like Figure 6C As shown, the joining structure 103 may include a cross-sectional profile 502 with a tapering peak. (And...) Figure 6A and Figure 6B Compared to the features of the bumps or serrated structures shown, tapered peaks can provide different auditory and / or tactile feedback. Figure 6A and Figure 6B The structures shown are similar, and the height and spacing of the taper peaks can be varied to provide the desired auditory or tactile signal.

[0089] In some embodiments, different engagement structures 103 may utilize different features to provide different signals to the operator. In some embodiments, a single engagement structure 103 may utilize... Figures 6A to 6C The combination of features described in the text.

[0090] As shown, Figure 7A This is a perspective view of the sleeve fastener 144 connected to the straight sleeve component 124, which is also shown in the figure. Figure 2 The embodiments are as shown and discussed above. However, as... Figure 7B As shown, the sleeve component can also be configured to include a bend. Figure 7BA sleeve component 124a with a slight bend or curvature 290 is shown. The bend 290 may be adjacent to the sleeve retainer 144 and provides an angular offset 292 of the axis 293 of the sleeve component 124a relative to the longitudinal axis 178 of the inserter 100 within the range of approximately 3 degrees to approximately 30 degrees, approximately 4 degrees to approximately 15 degrees, approximately 5 degrees to approximately 13 degrees, or approximately 8 degrees.

[0091] For example, when the inserter is positioned above the cheekbone and close to the eye, the bend in the sleeve component 124a can improve accessibility to the area of ​​the eye.

[0092] Furthermore, as shown, the insertion portion or distal end portion 294 of the cannula component 124a may be substantially straight, while the deployment portion or proximal end portion 296 of the cannula component 124 may include a bend or a curve. In some embodiments, both the distal end portion 294 and the proximal end portion 296 may include curves or both may be straight with a curved section disposed between them. The proximal end portion 296 may be about one-quarter to about one-half of the total length of the cannula component 124a. In some embodiments, the length of the proximal end portion 296 may be about one-third of the length of the cannula component 124a. Therefore, in some embodiments, the distal end portion 294 may be about one-half to about three-quarters of the length of the cannula component 124a, and in some embodiments, it may be about two-thirds of the length of the cannula component 124a. Thus, advantageously, the distal end portion 294 of the cannula component 124a may have sufficient length such that the cannula component 124a entering the eye is substantially straight overall.

[0093] While the cannula component 124a may include a rigid structure (which can withstand typical bending stresses of embodiments of the surgical procedure disclosed herein), the needle component 120 may be made of a flexible shaft that can be deflected as the needle component 120 is withdrawn from the proximal end into the cannula component 124a.

[0094] Therefore, the proximal end of the needle member 120, extending along the bend 290 of the cannula member 124a, can be retracted proximally into the cannula member 124a near the proximal end or the cannula retainer 144. Following such movement, although the proximal end of the needle member 120 is bent, the same portion of the needle member 120 can be bent and straightened when the needle member 120 is pulled proximally into the straight portion of the needle member 120 or into other components within the inserter. Furthermore, when the needle member 120 retracts proximally through the bend 290 of the cannula member 124a, the portion of the needle member 120 residing in the distal end of the cannula member 124a (and thus in a straight configuration) can be bent or offset into a folded or bent configuration.

[0095] Therefore, the use of the bow-shaped or curved sleeve component 124a in combination with the flexible or compliant needle component 120 allows some embodiments of the inserter to provide improved accessibility to the eye area.

[0096] Some embodiments may be implemented in aspects of the cannula structure and method of use disclosed in the applicant’s U.S. Patent Application Publication No. 2012 / 0123434, the entire contents of which are incorporated herein by reference.

[0097] Reference Figures 8A to 10A In some embodiments, for certain reasons discussed herein, it may be desirable for the shaft or pin component 120 to include a bend. In some embodiments, the bend may be between about 1 degree and about 20 degrees, between about 2 degrees and about 18 degrees, between about 3 degrees and about 16 degrees, between about 4 degrees and about 14 degrees, between about 3 degrees and about 16 degrees, between about 5 degrees and about 12 degrees, between 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.

[0098] Optionally, in some embodiments, the needle component 120 may remain in a bent configuration. According to some embodiments, the cannula component 124 may be straight and / or may be selectively angled or bent using removable or reconfigurable end components, deflector components, or alignment guide 602. In some embodiments, the inserter 100 may be delivered together with the alignment guide 602, which is coupled to the inserter 100 or disposed on the cannula component 124.

[0099] Reference Figure 8A The alignment guide 602 may include a hollow guide shaft 603 coupled to the attachment 604. To allow the alignment guide 602 to be rotatably oriented relative to the housing 102 of the inserter 100, the attachment 604 may be keyed or indexed. For example, the attachment 604 may be used to engage the alignment guide 602 to the housing 102 at a desired angle or rotational orientation to set the bending direction of the needle relative to the longitudinal axis of the housing 102 of the inserter 100.

[0100] In some embodiments, a hollow guide shaft 603 may be disposed on portions of the cannula member 124 and the needle member 120. The guide shaft 603 may have an angle similar to or defining the angle of the angled cannula member described herein. For example, the alignment guide 602 may bend the cannula member 124 and the needle member 120 at a bend 690, and provides a range of angular offset 692 of the axis 693 of the guide shaft 603 relative to the longitudinal axis 178 of the inserter 100: between approximately 0 degrees and approximately 30 degrees, between approximately 0 degrees and approximately 20 degrees, between approximately 0 degrees and approximately 15 degrees, or approximately 8 degrees.

[0101] Therefore, in some embodiments, an operator can modify the inserter's needle by applying an alignment guide to it, thereby bending the needle to a desired angular orientation. The alignment guide may be part of a set of alignment guides with different angular orientations. The alignment guide can be adapted to any existing inserter. Furthermore, the alignment guide may be configured to mate with the distal end of the inserter to securely engage the alignment guide rotatably and longitudinally relative to the inserter.

[0102] For example, in some embodiments, the operator may rotate the needle until the bevel begins to push the conjunctiva away from the sclera, as discussed and illustrated in U.S. Patent No. 9,585,790, the entire contents of which are incorporated herein by reference. This surgical procedure, which may be referred to as conjunctival “tenting,” creates a small space or gap between the conjunctiva and sclera adjacent to the bevel of the needle. Once a space is created by tenting the conjunctiva, the shunt can be advanced from the needle into that space. As a result, because the conjunctiva has been pushed aside and does not immediately obstruct the shunt from entering the subconjunctival space, the shunt can be pushed into the space more easily.

[0103] Additionally, in some embodiments, the insertion portion or distal end portion 694 of the guide shaft 603 may be generally straight, while the deployment portion or proximal end portion 696 of the guide shaft 603 may include a bend or a curve. Furthermore, in some embodiments, both the distal end portion 694 and the proximal end portion 696 may include a curve or both may be straight (wherein the curved section is disposed between the distal and proximal ends). The proximal end portion 696 may 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 may be about one-third of the length of the guide shaft 603. Correspondingly, in some embodiments, the distal end portion 694 may be about one-half to about three-quarters of the length of the guide shaft 603, and in some embodiments, it may be about two-thirds of the length of the guide shaft 603.

[0104] The alignment guide 602 allows the operator to modify the angles of the cannula component 124 and the needle component 120 prior to the surgical procedure (e.g., by allowing the operator to choose from a variety of different alignment guides with different angular orientations and relative length configurations of the proximal and distal ends) without having to replace the needle component 120 of the inserter 100. Furthermore, the guide shaft 603 provides enhanced rigidity to the cannula component 124 and the needle component 120. In some embodiments, the alignment guide 602 can facilitate the use of finer gauge needles in the needle component 120, including but not limited to gauge 28 or smaller needles. Therefore, embodiments of this disclosure advantageously allow the use of very small, fine needles in the delivery of intraocular shunts while ensuring that the needle exhibits sufficient strength and rigidity during delivery.

[0105] The cannula component 124 and the needle component 120 can be flexible or resilient to allow deflection during the installation of the alignment guide 602. The alignment guide 602 can be removed to allow the cannula component 124 and the underlying needle component 120 to move into a default straight configuration. For example, the alignment guide 602 can be configured to resiliently deform the cannula component 124. Therefore, when the alignment guide 602 is removed, the cannula component 124 and the needle component 120 will return to a straight configuration. Furthermore, the alignment guide 602 can be reinstalled on the housing 102 if desired.

[0106] like Figures 8A to 8C As shown, in some embodiments, proper rotational alignment of the alignment guide 602 can be facilitated by the attachment 604, which can be oriented relative to the housing 102 by keying or indexing. The indexing groove 605 of the attachment 604 can be aligned with the indexing protrusion 105 of the housing 102. In some embodiments, the indexing groove 605 can be keyed to the indexing protrusion 105 to allow the alignment guide 602 to be attached to the housing 102 in a desired orientation. Therefore, the alignment guide 602 and the inserter 100 can be configured to have one or more predetermined relative orientations. The indexing groove 605 can have the shape of a longitudinally extending notch or slot formed in the attachment 604.

[0107] Furthermore, the indexing grooves 605 may be spaced apart from each other at equal circumferential distances (e.g., circumferentially), and the indexing protrusions 105 may be spaced apart from each other at equal circumferential intervals (e.g., circumferentially), 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 may vary. Figures 8A to 8CIn the illustrated embodiment, there are four preset rotational orientations. In some embodiments, the alignment guide 602 may include a single indexing groove 605 that can mate with a single indexing protrusion 105 of the housing 102, such that the alignment guide 602 has a single rotational orientation relative to the inserter 100.

[0108] The attachment portion 604 may have the same number of indexing grooves 605 as the number of indexing protrusions 105. However, in some embodiments, the alignment guide 602 may include more indexing grooves 605 than the number of indexing protrusions 105 present. For example, while there may be four indexing protrusions 105 and four indexing grooves 605, there may 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 may be 1:4, 1:5, 1:6, or higher.

[0109] Figure 9A This is a front perspective view of another modifiable end component, deflector component, or alignment guide 700 according to some embodiments. Similar to... Figures 8A to 8C The alignment guide 602 and alignment guide 700 shown can be used to bend or hold the sleeve component 124 in a straight and / or selectively angled or bent configuration. As discussed herein, some details or uses of alignment guide 602 can also be achieved with alignment guide 700, which will not be repeated here for the sake of brevity.

[0110] like Figure 9A and Figure 9B As shown, the alignment guide 700 may include a guide shaft 702 coupled to the attachment portion 704. Similar to the alignment guide 602, the attachment portion 704 may include one or more indexing grooves 706, which facilitate the alignment and / or coupling of the guide 700 relative to the housing 102 of the inserter 100.

[0111] Similar to the alignment guide 602 discussed above, the inserter 100 can be delivered with the alignment guide 700 coupled to the inserter 100 or disposed on the cannula member 124. In some embodiments, the hollow guide shaft 702 may be disposed on portions of the cannula member 124 and the needle member 120. The guide shaft 702 may have an angle similar to or defined to the angled cannula member described herein. The alignment guide 700 may bend the cannula member 124 and the needle member 120 and provides an angular offset 710 of the axis 712 of the guide shaft 702 relative to the longitudinal axis 178 of the inserter 100 within the range of approximately 0 degrees to approximately 30 degrees, approximately 0 degrees to approximately 20 degrees, approximately 0 degrees to approximately 15 degrees, or approximately 8 degrees.

[0112] Additionally, similar to the alignment guide 602, the insertion portion or distal end portion 720 of the guide shaft 702 may be generally straight, while the deployment portion or proximal end portion 722 of the guide shaft 702 may include a bend or a curve. Furthermore, in some embodiments, both the distal end portion 720 and the proximal end portion 722 may include a curve or both may be straight (wherein the curved section is disposed between the distal and proximal ends). The proximal end portion 722 may be about one-quarter to about one-half of the total length of the guide shaft 702. In some embodiments, the length of the proximal end portion 722 may be about one-third of the length of the guide shaft 702. Accordingly, in some embodiments, the distal end portion 720 may be about one-half to about three-quarters of the length of the guide shaft 702, and in some embodiments, it may be about two-thirds of the length of the guide shaft 702.

[0113] Similar to alignment guide 602, alignment guide 700 allows the operator to modify the angles of the cannula component 124 and the needle component 120 prior to the surgical procedure (e.g., by allowing the operator to choose from a variety of different alignment guides with different angular orientations and relative lengths of the proximal and distal ends) without having to replace the needle component 120 of the inserter 100. Furthermore, guide shaft 702 provides enhanced rigidity to the cannula component 124 and the needle component 120. In some embodiments, alignment guide 700 can facilitate the use of finer gauge needles in the needle component 120, including but not limited to gauge 28 or smaller needles. Therefore, embodiments of this disclosure advantageously allow the use of very small, fine needles in the delivery of intraocular shunts while ensuring that the needle exhibits sufficient strength and rigidity during delivery.

[0114] As described above, the cannula component 124 and the needle component 120 can be flexible or resilient to allow deflection during the installation of the alignment guide 700. The alignment guide 700 can be removed to allow the cannula component 124 and the underlying needle component 120 to move into a default straight configuration. For example, the alignment guide 700 can be configured to resiliently deform the cannula component 124. Therefore, when the alignment guide 700 is removed, the cannula component 124 and the needle component 120 will return to a straight configuration. Furthermore, if desired, the alignment guide 700 can be reinstalled on the housing 102.

[0115] As mentioned above Figures 8A to 8C Similarly, it can be pointed out that the attachment part 704 can be used to make Figure 9A and Figure 9BThe alignment guide 700 is appropriately rotated and aligned relative to the inserter 100. The attachment portion 704 can orient the alignment guide 700 relative to the housing 102 via keying or indexing. The indexing groove 706 of the attachment portion 704 can be aligned with the indexing protrusion 105 of the housing 102. In some embodiments, the indexing groove 706 can be keyed to the indexing protrusion 105 to allow the alignment guide 700 to be attached to 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 have the shape of a longitudinally extending notch or slot formed in the attachment portion 704.

[0116] Furthermore, the indexing grooves 706 may be spaced apart from each other at equal circumferential distances (e.g., circumferentially), and the indexing protrusions 105 may be spaced apart from each other at equal circumferential intervals (e.g., circumferentially), such that the alignment guide 700 can be rotated to one or more preset rotational orientations. However, the circumferential distance between the indexing grooves 706 and / or the indexing protrusions 105 may vary. Figure 9A and Figure 9B In the illustrated embodiment, there are four preset rotational orientations. In some embodiments, the alignment guide 700 may include a single indexing groove 706 that can mate with a single indexing protrusion 105 of the housing 102, such that the alignment guide 700 has a single rotational orientation relative to the inserter 100.

[0117] The attachment portion 704 may have the same number of indexing grooves 706 as the number of indexing protrusions 105. However, in some embodiments, the alignment guide 700 may include more indexing grooves 706 than the number of indexing protrusions 105 present. For example, while there may be four indexing protrusions 105 and four indexing grooves 706, there may also be four indexing protrusions 105 and eight indexing grooves 706, four indexing protrusions 105 and twelve indexing grooves 706, or a ratio of indexing protrusions 105 to indexing grooves 706 of 1:4, 1:5, 1:6, or higher.

[0118] According to some embodiments, the attachment portion 704 of the alignment guide 700 may include one or more retaining or engaging features that enable the alignment guide to snap onto or engage with a corresponding engaging feature at the distal end of the inserter 100. These features may also be used in conjunction with the attachment portion 604 of the alignment guide 602.

[0119] According to some embodiments, various components can be used to protect the needle component of the inserter. These components can be used individually or in combination to reposition and / or protect the needle component (e.g., the bevel of the needle component) from damage during transport or loading 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 protection devices. Examples of these components and their combinations will be described below. Figure 10A and Figure 10B Let's have a discussion.

[0120] like Figure 10A and Figure 10B As shown, in some embodiments, the bevel protection device 820 can be inserted into the needle component 120 to protect the beveled area or bevel 800 of the needle component 120. Figure 10A As shown, in some embodiments, alignment guide 602 (or alignment guide 700) may be coupled to inserter 100 and used to angle cannula member 124 and / or needle member 120 to protect cannula member 124 and / or needle member 120 by tilting cannula member 124 toward protective cap 610 while inserting bevel protection device 820 into needle member 120. Thus, as shown, bevel protection device 820 may extend distally from needle member 120 and contact the inner sidewall of protective cap 610. Therefore, when alignment guide 602 bends needle member 120 in a direction away from the central axis of protective cap 610 (or toward the sidewall of protective cap 610), bevel protection device 820 may be configured to contact the sidewall of protective cap 610, thereby spacing the bevel 800 of needle member 120 away from and preventing contact with the sidewall of protective cap 610.

[0121] Additionally, the protective cap 610 is configured to engage with a portion of the housing 102 to secure the protective cap 610 to the distal end of the housing 102, thereby covering and protecting the sleeve component 124 and the needle component 120.

[0122] As described above, according to some embodiments, the bevel protection device 820 can also be used to reduce or prevent accidental contact between the bevel 800 of the needle component and other structures (e.g., the protective cap 610) during transport and loading of the inserter or needle assembly. When used in conjunction with the alignment guide 602 or 700, the alignment guide 602 or 700 can induce desired contact between the bevel protection device 820 and the protective cap 610 to position the needle component 120 in a protected position. However, in some embodiments, the bevel protection device 820 can be used alone, or in conjunction with one or both of the protective cap 610 and the alignment guide 602 or 700.

[0123] The inserter 100 can be used in conjunction with a bevel protection device that engages with the needle component 120 of the inserter 100 to prevent accidental damage to the bevel 800 of the needle component 120. In some embodiments, the bevel protection device described herein can be used in conjunction with an angled sleeve component 124 and / or alignment guide 602 or 700 to arrange the end of the protection device against the protective cap 610.

[0124] For example, Figure 10B The distal end of the needle component 120 of the inserter is shown. A beveled guard 820 can engage with the distal end 822 of the needle component 120. The beveled guard 820 may include an elongated body 824 comprising a first portion 826 and a second portion 828. The first portion 826 may taper from a larger diameter cross-section to a smaller diameter cross-section. The smaller diameter cross-section may be smaller than the inner diameter of the distal end 822 of the needle component 120. Therefore, the first portion 826 can be inserted into the lumen 830 of the needle component 120.

[0125] The elongated body 824 can be configured such that the taper of the first portion 826 provides the elongated body 824 with a cross-section of variable diameter. This diameter can be gradually tapered or progressively tapered.

[0126] like Figure 10B As shown in the illustrated embodiment, the cross-sectional profile or diameter of the elongated body 824 adjacent to the second portion 828 can be larger than the cross-sectional profile or diameter of the elongated body 824 adjacent to the first portion 826. For example, from the first portion 826 to the second portion 828, the cross-sectional diameter of the elongated body 824 can increase from a diameter smaller than the inner diameter of the lumen 830 of the needle component 120 to a diameter larger than the inner diameter of the lumen 830. Therefore, the elongated body 824 can be inserted into the lumen 830 of the needle component 120 and advance to a position where the cross-section of the elongated body is approximately equal to the inner diameter of the lumen 830, thereby limiting the further advancement of the bevel protection device 820 into the lumen 830.

[0127] In some embodiments, the elongated body 824 may frictionally engage with the distal end 822 of the needle component 120. For example, the retaining device 820 may be forcibly fitted into the needle component 120 to create frictional engagement between the outer surface of the elongated body 824 and the inner surface of the lumen 830. This frictional engagement can be overcome by applying a pull-out force to a second portion 828 of the retaining device 820, thereby pulling the beveled guard device 820 out of the lumen 830.

[0128] Although the bevel protection device 820 is shown as having a circular or diametrically opposed cross-section, other cross-sections, such as triangular, square, rectangular, polygonal, star-shaped, or other similar contours, may also be used. Furthermore, the bevel protection device 820 may be made of steel. According to some embodiments, the bevel protection device 820 may only contact the interior of the needle bevel 800, and therefore advantageously does not affect the sharpness of the needle driven by the outer edge of the needle.

[0129] Therefore, the bevel protection device 820 ensures that the edge of the bevel 800 of the needle does not come into contact with other surfaces, preventing damage during loading or initial handling of the inserter or needle assembly. When the operator is ready to use the inserter, the bevel protection device 820 can be removed from the needle assembly 120, and the surgical procedure can be performed.

[0130] Furthermore, in some embodiments, the inserter 100 may include a tactile or auditory feedback mechanism that does not require or generate a consistent or durable frictional engagement against the housing 102. Therefore, the features of the inserter discussed herein may be incorporated into some embodiments, while excluding other features discussed herein.

[0131] Although the detailed description contains numerous details, these details should not be construed as limiting the scope of the subject matter, but merely as illustrating different examples and aspects of the subject matter. It should be understood that the scope of the subject matter includes other embodiments not discussed in detail above. Various other modifications, alterations, and variations can be made to the arrangement, operation, and details of the methods and apparatus of the subject matter disclosed herein without departing from the scope of this disclosure. Unless expressly stated, singular references are not intended to mean "one and only one," but rather "one or more." Furthermore, an apparatus or method need not solve every problem that can be solved by the different embodiments of this disclosure to be included within the scope of this disclosure.

[0132] Subject technology as an explanation of the item

[0133] For convenience, various examples of aspects of this disclosure are described below as items. These are provided by way of example only and do not limit the subject matter.

[0134] Item 1. An intraocular shunt inserter for treating glaucoma, comprising: a housing having a distal end, a proximal end, and a longitudinal axis extending between the distal end and the proximal end, the housing further comprising an inner 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, the elongated slot extending along the longitudinal axis into the inner cavity along the outer surface of the housing; and a slider member slidably coupled to the housing along the outer surface of the housing, the slider member being slidable along the elongated slot to actuate the function of the inserter via the elongated slot, the slider member including a guide plate and a friction plate, the guide plate being disposed within and slidable along the guide channel of the housing, the friction plate being movable relative to the guide plate and including a biasing portion configured to push the friction plate against the housing so that the guide plate contacts the inner wall of the guide channel, for providing frictional resistance against sliding between the slider member and the housing.

[0135] Clause 2. The inserter according to Clause 1, wherein the slider component includes an inner region, and the housing engages with the inner region.

[0136] Clause 3. The inserter according to Clause 2, wherein the internal region is semi-cylindrical.

[0137] Clause 4. The inserter according to any one of Clauses 2 to 3, wherein the friction pad extends inward toward the inner region of the slider component to contact the outer surface of the housing.

[0138] Clause 5. The inserter according to Clause 4, wherein the friction pads include a pair of friction pads extending inward toward the inner region of the slider component.

[0139] Clause 6. The inserter according to any one of Clauses 2 to 5, wherein the guide plate extends inward toward the inner region of the slider component.

[0140] Clause 7. The inserter according to any one of Clauses 2 to 6, wherein the guide tabs comprise a pair of guide tabs extending inward toward the inner region of the slider component.

[0141] Clause 8. The inserter according to any one of Clauses 2 to 8, wherein the slider component comprises a generally cylindrical profile, and the guide pieces are spaced apart from each other at about 90 degrees to about 180 degrees along the inner surface of the inner region.

[0142] Clause 9. The inserter according to any one of the preceding clauses, wherein when the slider component is coupled to the housing, the slider component contacts the housing only via the guide plate and the friction plate.

[0143] Clause 10. The inserter according to any one of the preceding clauses, wherein the guide tabs comprise a pair of guide tabs, each of the pair of guide tabs including a longitudinally extending flange configured to be located within the guide channel.

[0144] Clause 11. The inserter according to any one of the preceding clauses, wherein the housing comprises a generally cylindrical profile, and a pair of guide channels are spaced apart from each other at about 90 degrees to about 180 degrees along the outer surface of the housing.

[0145] Clause 12. The inserter according to Clause 11, wherein the guide channels are arranged to be spaced approximately 180 degrees apart.

[0146] Clause 13. The inserter according to any one of the preceding clauses, wherein the guide piece, the friction piece, and the slider component are formed as a single continuous material piece.

[0147] Clause 14. The inserter according to any one of the preceding clauses, wherein the friction pad is formed as a cut through the body of the slider component.

[0148] Clause 15. The inserter according to Clause 14, wherein the friction pad includes a protrusion extending toward the inner region of the slider component.

[0149] Clause 16. The inserter according to Clause 15, wherein when the slider component is coupled to the housing, the protrusion of the friction pad contacts the housing.

[0150] Clause 17. The inserter according to Clause 16, wherein the protrusion of the friction pad contacts the housing to cause the friction pad to bend in a direction away from the guide plate.

[0151] Clause 18. The inserter according to any one of the preceding clauses, wherein the housing comprises a generally cylindrical profile.

[0152] Clause 19. The inserter according to any one of the preceding clauses, wherein the housing includes an engagement structure, and the friction pad can abut against the engagement structure to contact the housing to provide auditory or tactile feedback to the operator.

[0153] Clause 20. The inserter according to Clause 19, wherein the engagement structure includes at least one discontinuity in the outer surface of the housing.

[0154] Clause 21. The inserter according to Clause 19, wherein the engagement structure includes at least one protrusion on the outer surface of the housing.

[0155] Clause 22. The inserter according to Clause 19, wherein the engagement structure includes a plurality of serrated features on the outer surface of the housing.

[0156] Clause 23. The inserter according to Clause 19, wherein the engagement structure includes a plurality of tapering peaks on the outer surface of the housing.

[0157] Clause 24. The inserter according to Clause 19, wherein the inserter functions to advance the diverter within the needle, and the position of the slider component along the engagement structure corresponds to the deployment position of the diverter relative to the needle.

[0158] Clause 25. The inserter according to Clause 19, wherein the engagement structure includes a plurality of protrusions on the outer surface of the housing, wherein each of the protrusions corresponds to the deployment position of the intraocular shunt.

[0159] Clause 26. The inserter according to any one of the preceding clauses, wherein the slider component is operatively coupled to a deployment mechanism within the housing.

[0160] Clause 27. The inserter according to Clause 26, wherein the slider component is connected to the deployment mechanism via a rod extending through the elongated slot, the rod being connected to the slider component and the deployment mechanism.

[0161] Clause 28. The inserter according to any one of the preceding clauses further includes a hollow needle, the hollow needle including a curved portion bent at an angle between about 6 degrees and about 10 degrees, the needle being configured to carry an intraocular shunt.

[0162] Clause 29. The inserter according to Clause 28, wherein the needle defines a straight portion and an angled portion.

[0163] Clause 30. The inserter according to any one of the preceding clauses further includes a hollow needle extending from a distal end of the inserter, the inserter further including a deflector component releasably attached to the distal end of the inserter, and wherein when the deflector component is coupled to the inserter, the hollow needle extends through the deflector component, and the deflector holds the needle in a bent configuration.

[0164] Clause 31. The inserter according to Clause 30, wherein, in the bent configuration, the needle is bent at an angle between about 6 degrees and about 10 degrees.

[0165] Clause 32. The inserter according to Clause 30, wherein the needle elastically deforms when connected to the deflector.

[0166] Clause 33. The inserter according to Clause 30, wherein the distal end of the inserter includes an indexing structure, and the deflector component includes an alignment indexing portion, wherein the alignment indexing portion of the deflector component can be releasably engaged with the indexing structure to define a rotational orientation of the deflector component relative to the inserter.

[0167] Clause 34. The inserter according to Clause 33, wherein the deflector component includes a curved needle guide attached to and extending from the connector, wherein the alignment indexing portion is formed along the connector.

[0168] Clause 35. The inserter according to Clause 34, wherein the alignment indexing portion is positioned along the proximal end of the connector.

[0169] Clause 36. The inserter according to Clause 34, wherein the alignment indexing portion includes at least one groove extending along the periphery of the connector.

[0170] Clause 37. The inserter according to Clause 34, wherein the needle guide includes a hollow shaft.

[0171] Clause 38. The inserter according to Clause 33, wherein the indexing structure includes at least one protrusion configured to slide into a corresponding groove.

[0172] Item 39. An intraocular shunt inserter for treating glaucoma, comprising: a housing having a distal end, a proximal end, and a longitudinal axis extending between the distal end and the proximal end, the housing further comprising an inner cavity, a guide channel, and an elongated slot extending along an outer surface of the housing into the inner cavity for actuating the inserter; and a slider component coupled to the housing and positioned along the outer surface of the housing, the slider component being slidable along the elongated slot, the slider component including a guide tab disposed within the guide channel; and a position feedback mechanism including a bias tab and an engagement structure, the bias tab being coupled to the slider component, the engagement structure being formed along the outer surface of the housing, wherein movement of the slider component causes the bias tab to slide along the engagement structure to generate tactile or auditory feedback to an operator regarding the position of the intraocular shunt relative to the inserter.

[0173] Clause 40. The inserter according to Clause 39, wherein the engagement structure includes at least one discontinuity in the outer surface of the housing.

[0174] Clause 41. The inserter according to any one of Clauses 39 to 40, wherein the engagement structure includes at least one protrusion on the outer surface of the housing.

[0175] Clause 42. The inserter according to any one of Clauses 39 to 41, wherein the engagement structure includes a plurality of serrated features on the outer surface of the housing.

[0176] Clause 43. The inserter according to any one of Clauses 39 to 42, wherein the engagement structure includes a plurality of tapering peaks on the outer surface of the housing.

[0177] Clause 44. The inserter according to any one of Clauses 39 to 43, wherein the inserter functions to advance the diverter within the needle, and the position of the slider component along the engagement structure corresponds to the deployment position of the diverter relative to the needle.

[0178] Article 45. The inserter according to any one of Articles 39 to 44, wherein the engagement structure includes a plurality of protrusions on the outer surface of the housing, wherein each of the protrusions corresponds to the deployment position of the intraocular shunt.

[0179] Clause 46. The inserter according to Clause 45, wherein each of the plurality of protrusions is disposed along the housing at a position corresponding to the rotational position of the drive component of the deployment mechanism of the inserter.

[0180] Clause 47. The inserter according to any one of Clauses 39 to 46 further includes a hollow needle extending from a distal end of the inserter, the inserter further including a deflector member releasably attached to the distal end of the inserter, and wherein when the deflector member is coupled to the inserter, the hollow needle extends through the deflector member, and the deflector holds the needle in a bent configuration.

[0181] Clause 48. The inserter according to Clause 47, wherein, in the bent configuration, the needle is bent at an angle between about 6 degrees and about 10 degrees.

[0182] Clause 49. The inserter according to Clause 47, wherein the needle elastically deforms when connected to the deflector.

[0183] Clause 50. The inserter according to Clause 52, wherein the needle guide includes a hollow shaft.

[0184] Clause 51. The inserter according to Clause 47, wherein the distal end of the inserter includes an indexing structure, and the deflector component includes an alignment indexing portion, wherein the alignment indexing portion of the deflector component can be releasably engaged with the indexing structure to define a rotational orientation of the deflector component relative to the inserter.

[0185] Clause 52. The inserter according to Clause 51, wherein the deflector component includes a curved needle guide attached to and extending from the connector, wherein the alignment indexing portion is formed along the connector.

[0186] Clause 53. The inserter according to Clause 52, wherein the alignment indexing portion is positioned along the proximal end of the connector.

[0187] Clause 54. The inserter according to Clause 52, wherein the alignment indexing portion includes at least one groove extending along the periphery of the connector.

[0188] Clause 55. The inserter according to Clause 54, wherein the indexing structure includes at least one protrusion configured to slide into the at least one groove.

[0189] Clause 56. The inserter according to Clause 47, wherein the needle is elastically deformable.

[0190] Item 57. A method of operating an intraocular shunt inserter, the method comprising: advancing the slider component distally along the housing by overcoming frictional resistance between a friction plate of a slider component and a housing of the intraocular shunt inserter, the slider component being slidably actuating the function of the inserter, the slider component including a guide plate and a friction plate, the guide plate being disposed within and slidable along a guide channel of the housing, the friction plate being movable relative to the guide plate and including a biasing portion configured to push the friction plate against the housing so that the guide plate contacts an inner wall of the guide channel, thereby providing frictional resistance between the slider component and the housing; and contacting a plunger engaged with the slider against a shunt disposed within a needle of the inserter so that the shunt advances distally within the needle.

[0191] Clause 58. The method according to Clause 57 further includes: engaging the discontinuities of the housing via the friction pad.

[0192] Article 59. The method according to Article 58 further includes: generating an auditory signal by engaging the discontinuity.

[0193] Article 60. The method according to any one of Articles 58 to 59, wherein the position of the discontinuity corresponds to the position of the shunt within the lumen of the needle.

[0194] Clause 61. The method according to Clause 60, wherein the discontinuity includes a bump.

[0195] Article 62. The method according to Article 60, wherein the discontinuity includes a serrated feature.

[0196] Article 63. The method according to Article 60, wherein the discontinuity comprises a tapering peak.

[0197] Clause 64. The method according to any one of Clauses 57 to 63 further comprises: bending the needle of the inserter by attaching a deflector component to the distal end of the inserter.

[0198] Clause 65. The method according to Clause 64, wherein the bending comprises inserting the needle through the deflector component to bend the needle.

[0199] Clause 66. The method according to Clause 64, wherein the bending comprises bending the needle at an angle between about 6 degrees and about 10 degrees.

[0200] Clause 67. The method according to Clause 64, wherein the deflector component defines a straight insertion portion and an angled deployment portion.

[0201] Clause 68. The method according to Clause 64 further includes: aligning the deflector component with the distal end of the inserter via an indexing mechanism.

[0202] Clause 69. The method according to Clause 68, wherein the indexing mechanism includes at least one protrusion at the distal end of the inserter.

[0203] Article 70. The method according to any one of Articles 57 to 69 further comprises: elastically deforming the needle.

[0204] Item 71. A system for deploying an intraocular shunt, the system comprising: an intraocular shunt inserter including a housing having a distal end and a needle extending from the distal end; and a deflector component releasably attached to the distal end of the inserter, the deflector component having a needle guide configured to receive the needle of the inserter, wherein the needle guide holds the needle in a bent configuration.

[0205] Clause 72. The system according to Clause 71, wherein the needle guide includes a hollow shaft.

[0206] Article 73. The system according to any one of Articles 71 to 72, wherein, in the bending configuration, the needle bends at an angle between about 6 degrees and about 10 degrees.

[0207] Clause 74. The system according to any one of clauses 71 to 73, wherein the needle elastically deforms when it is engaged with the deflector component.

[0208] Clause 75. The system according to any one of Clauses 71 to 74, wherein the distal end of the inserter includes an indexing structure, and the deflector component includes an alignment indexing portion, wherein the alignment indexing portion of the deflector component is releasably engaged with the indexing structure to define a rotational orientation of the deflector component relative to the inserter.

[0209] Clause 76. The system according to Clause 75, wherein the deflector component includes a connector, the needle guide is attached to the connector, and the alignment indexing portion is formed along the connector.

[0210] Clause 77. The system according to Clause 76, wherein the alignment indexing portion is positioned along the proximal end of the connector.

[0211] Clause 78. The system according to Clause 76, wherein the alignment indexing portion includes at least one groove extending along the periphery of the connector.

[0212] Clause 79. The system according to Clause 76, wherein the indexing structure includes at least one protrusion configured to slide into a corresponding groove.

[0213] Item 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 a upper surface; and a semi-cylindrical slider disposed around the housing, wherein the slider is axially movable relative to the housing, the slider including: a pair of guide plates disposed within the respective guide channels of the housing to secure the slider to the housing; a friction plate disposed on the slider at the center of the guide plates, the friction plate including a biasing portion configured to push the friction plate against the housing so that the guide plates contact the inner wall of the guide channels; and a slider protrusion operatively coupled to a shunt deployment mechanism within the housing.

[0214] Clause 81. The conveying device according to Clause 80, wherein the guide channels are arranged at approximately 180 degrees apart from each other.

[0215] Clause 82. The conveying device according to any one of Clauses 80 to 81, wherein the sliding protrusion passes through the housing to reach the deployment mechanism.

[0216] Article 83. The conveying device according to any one of Articles 80 to 82, wherein the housing includes a engagement structure disposed along the outer surface of the housing, and the friction pad can abut against the engagement structure to contact the housing to provide auditory or tactile feedback to an operator.

[0217] Clause 84. The conveying device according to Clause 83, wherein the engagement structure includes a groove, a notch, or a protrusion.

[0218] Clause 85. The conveying device according to Clause 83, wherein the engagement structure includes at least one discontinuity to accommodate the bias portion.

[0219] Clause 86. The conveying device according to Clause 83, wherein the engagement structure includes at least one protrusion on the outer surface of the housing.

[0220] Clause 87. The conveying device according to Clause 83, wherein the engagement structure includes a plurality of serrated features on the outer surface of the housing.

[0221] Clause 88. The conveying device according to Clause 83, wherein the engagement structure includes a plurality of tapering peaks on the outer surface of the housing.

[0222] Article 89. The delivery device according to any one of Articles 80-88 further includes a hollow needle comprising a curved portion bent at an angle between about 6 degrees and about 10 degrees, and the hollow needle is configured to retain the intraocular shunt.

[0223] Clause 90. The conveying device according to Clause 89, wherein the curved portion defines a straight insertion portion and an angled deployment portion of the needle.

[0224] Clause 91. The conveying device according to Clause 89 further includes a deflector component releasably attached to a distal end of the conveying device, wherein, when the deflector component is coupled to the conveying device, the hollow needle extends through the deflector component, and the deflector retains the needle in a bent state.

[0225] Clause 92. The conveying device according to Clause 91, wherein the needle is elastically deformable.

[0226] Clause 93. The conveying device according to Clause 91, wherein the distal end of the conveying device includes an indexing structure, and the deflector component includes an alignment indexing portion, wherein the alignment indexing portion of the deflector component can be releasably engaged with the indexing structure to define the rotational orientation of the deflector component relative to the conveying device.

[0227] Item 94. An inserter device for deploying an intraocular shunt, the device comprising: a housing; a shunt deployment mechanism disposed within the housing; a deformable hollow needle coupled to the housing and the deployment mechanism for delivering the intraocular shunt; and a deflector component releasably attached to a distal end of the housing, the deflector component including a coupling body and a needle guide, the needle guide being positioned against a portion of the needle to position the needle in a flexural configuration.

[0228] Clause 95. The apparatus according to Clause 94, wherein the needle guide includes a curved portion bent at an angle between about 0 degrees and about 15 degrees.

[0229] Clause 96. The device according to any one of Clauses 94 to 95, wherein the needle guide includes a bend at an angle between about 2 degrees and about 10 degrees.

[0230] Clause 97. The device according to any one of Clauses 94 to 96, wherein the needle guide includes a bend at an angle between about 3 degrees and about 8 degrees.

[0231] Clause 98. The device according to any one of Clauses 94 to 97, wherein the needle guide includes a bend at an angle between about 4 degrees and about 6 degrees.

[0232] Article 99. The apparatus according to any one of Articles 94 to 98, wherein the needle guide comprises a straight insertion portion and an angled deployment portion.

[0233] Article 100. The device according to any one of Articles 94 to 99, wherein the needle is elastically deformable.

[0234] Clause 101. The device according to any one of clauses 94 to 100, wherein the housing includes an indexing structure and the deflector component includes an alignment indexing portion, wherein the alignment indexing portion of the deflector component can be releasably engaged with the indexing structure to define a rotational orientation of the deflector component relative to the inserter device.

[0235] Clause 102. The apparatus according to Clause 101, wherein the indexing structure includes a plurality of indexing grooves.

[0236] Clause 103. The apparatus according to Clause 102, wherein the plurality of indexing grooves are configured to receive a plurality of indexing protrusions of the deflector component.

[0237] Clause 104. The apparatus according to Clause 101, wherein the indexing structure defines multiple orientations in which the deflector component can engage with the housing.

[0238] Article 105. The device of any one of Articles 94 to 104 further includes the slider component described in any one of the preceding articles.

[0239] Article 106. A method of operating an intraocular shunt inserter, the method comprising: providing an inserter device for deploying an intraocular shunt, the device comprising: a housing having a distal end; 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 a needle guide of a deflector component to position the needle in a flexed configuration; and coupling the deflector component to the distal end of the housing, wherein a coupling body of the deflector component is positioned against the distal end.

[0240] Clause 107. The method according to Clause 106, wherein the insertion comprises bending the needle in the bent configuration at an angle between about 0 degrees and about 15 degrees.

[0241] Article 108. The method according to any one of Articles 106 to 107, wherein the insertion comprises bending the needle in the bent configuration at an angle between about 6 degrees and about 10 degrees.

[0242] Article 109. The method according to any one of Articles 106 to 108, wherein the insertion comprises bending the needle in the bent configuration at an angle between about 2 degrees and about 10 degrees.

[0243] Article 110. The method according to any one of Articles 106 to 109, wherein the insertion comprises bending the needle in the bent configuration at an angle between about 3 degrees and about 8 degrees.

[0244] Clause 111. The method according to any one of Clauses 106 to 110, wherein the insertion comprises bending the needle in the bent configuration at an angle between about 4 degrees and about 6 degrees.

[0245] Clause 112. The method according to any one of clauses 106 to 111, wherein the needle guide comprises a straight insertion portion and an angled deployment portion.

[0246] Clause 113. The method according to any one of Clauses 106 to 112 further comprises: aligning the deflector component with the distal end of the inserter via an indexing mechanism.

[0247] Clause 114. The method according to Clause 113, wherein the indexing mechanism includes at least one protrusion on the distal end of the inserter.

[0248] Clause 115. The method according to any one of Clauses 113 to 114, wherein the alignment comprises aligning the deflector component rotatably relative to the housing.

[0249] Clause 116. The method according to Clause 115, wherein the rotational alignment includes selecting an indexing rotation position from a plurality of rotational positions.

[0250] Clause 117. An apparatus comprising any of the features described in any of the preceding clauses.

[0251] Article 118. A method comprising any of the features described in any of the preceding articles.

[0252] Further consideration

[0253] In some embodiments, any clause herein may be subordinate to any independent clause or any dependent clause. In one aspect, any clause (e.g., dependent or independent clause) may be combined with any other clause (e.g., dependent or independent clause). In one aspect, the claims may include some or all of the words (e.g., steps, operations, means, or components) recorded in a clause, sentence, phrase, or paragraph. In one aspect, the claims may include some or all of the words recorded in one or more clauses, sentences, phrases, or paragraphs. In one aspect, some words may be removed from each clause, sentence, phrase, or paragraph. In one aspect, additional words or elements may be added to a clause, sentence, phrase, or paragraph. In one aspect, the subject matter may be implemented without utilizing certain components, elements, functions, or operations described herein. In one aspect, the subject matter may be implemented using additional components, elements, functions, or operations.

[0254] Unless explicitly stated otherwise, elements referenced in the singular are not intended to refer to one and only one, but rather to one or more. For example, a “one” module can refer to one or more modules. Unless otherwise specified, elements beginning with “a,” “an,” “the,” or “the” do not preclude the existence of other identical elements.

[0255] Titles and subtitles (if any) are for convenience only and do not limit the invention. The word “exemplary” is used to indicate that it serves as an example or illustration. When “comprising” is interpreted as a transitional word in the claims, it is intended to be included in a similar manner to the term “comprising”. Relational terms such as “first” and “second” can be used to distinguish one entity or action from another without necessarily requiring or implying any actual such relationship or order between these entities or actions.

[0256] Phrases such as "one aspect," "this aspect," "on the other hand," "some aspects," "one or more aspects," "one implementation," "this implementation," "another implementation," "some implementations," "one or more implementations," "an embodiment," "this embodiment," "another embodiment," "some embodiments," "one or more embodiments," "construction," "this construction," "another construction," "some constructions," "one or more constructions," "the subject matter," "this disclosure," "the present disclosure," and other variations thereof are used for convenience and do not imply that the disclosure associated with such a phrase is essential to the subject matter or that such disclosure applies to all constructions of the subject matter. Disclosures associated with such phrases may apply to all constructions or one or more constructions. Disclosures associated with such phrases may provide one or more examples. Phrases such as "one aspect" or "some aspects" may refer to one or more aspects, and vice versa, and this similarly applies to other foregoing phrases.

[0257] The phrase "at least one" preceding a series of items (where the terms "and" or "or" are used to separate any items) modifies the list as a whole, rather than each component of the list. The phrase "at least one" does not require the selection of at least one of the listed items; rather, the phrase allows for the inclusion of at least one of any of the items, and / or at least one of any combination of the items, and / or at least one of each of the items. For example, the phrases "at least one of A, B, and C" or "at least one of A, B, or C" respectively refer to only A, only B, or only C; any combination of A, B, and C; and / or at least one of each of A, B, and C.

[0258] It should be understood that the specific order or hierarchy of the disclosed steps, operations, or processes is an illustration of exemplary methods. Unless otherwise expressly stated, it should be understood that the specific order or hierarchy of steps, operations, or processes may be performed in a different order. Certain steps, operations, or processes may be performed simultaneously. The appended method claims (if any) present elements of various steps, operations, or processes in an exemplary order, but this does not imply limitation to the specific order or hierarchy presented. These may be performed in series, linearly, in parallel, or in a different order. It should be understood that the described instructions, operations, and systems can generally be integrated together in a single software / hardware product or packaged into multiple software / hardware products.

[0259] On the one hand, the term "connection" can refer to a direct connection. On the other hand, the term "connection" can refer to an indirect connection.

[0260] Terms such as top, bottom, front, back, side, horizontal, and vertical are used with reference to an arbitrary frame of reference, not a typical gravitational frame of reference. Therefore, in a gravitational frame of reference, such terms can extend upwards, downwards, diagonally, or horizontally.

[0261] 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 matter. This disclosure provides various examples of the subject matter, and the subject matter is not limited to these examples. Various modifications to these aspects will be apparent to those skilled in the art, and the principles described herein can be applied to other aspects.

[0262] All structural and functional equivalents of elements throughout the various aspects described in this disclosure are expressly incorporated herein by reference and are intended to be covered by the claims. Furthermore, nothing disclosed herein is intended to be offered to the public, whether or not such disclosure is expressly stated in the claims. Pursuant to paragraph 6 of 35 U.S.SC § 112, no claim element shall be interpreted unless the element is expressly stated using the phrase “means for…” or, in the case of a method claim, using the phrase “step for…”.

[0263] The title, background art, brief description of the drawings, abstract, and drawings are hereby incorporated into this disclosure and are provided as illustrative examples rather than limiting descriptions. The premise of the claims is that they are not intended to limit the scope or meaning of the claims. Furthermore, it will be apparent from the detailed description that exemplary examples are provided and that various features are grouped together in various embodiments for the purpose of simplifying the disclosure. The approach of this disclosure should not be construed as reflecting an intention that the claimed subject matter requires more features than expressly recited in each claim. Rather, as reflected in the claims, the inventive subject matter lies in all features of fewer than those in a single disclosed construction or operation. The claims are hereby incorporated into the detailed description, each claim itself as a separately claimed subject matter.

[0264] The claims are not intended to be limited to the aspects described herein, but are to be given the full scope consistent with the language of the claims and to cover all legal equivalents. Nevertheless, no claim is intended to include subject matter that does not meet the requirements of applicable patent law, nor should they be interpreted in this manner.

Claims

1. A system for deploying an intraocular shunt, the system comprising: An intraocular shunt inserter includes a housing having a distal end, an indexing structure disposed along the distal end, and a hollow needle extending from the distal end; as well as A deflector component releasably attached to the distal end of the inserter, the deflector component having an alignment indexing portion and a needle guide configured to receive the hollow needle of the inserter, wherein the needle guide holds the hollow needle in a bent configuration, and wherein the alignment indexing portion includes one or more longitudinally extending grooves indexed at a predetermined angle about a longitudinal axis relative to the needle guide and extending radially relative to the housing, and releasably engaging with the indexing structure of the housing to define the rotational orientation of the needle guide relative to the inserter and resist rotational movement of the deflector component relative to the inserter.

2. The system according to claim 1, wherein, The needle guide includes a hollow shaft.

3. The system according to claim 1, wherein, In the bending configuration, the hollow needle is bent at an angle between 6 and 10 degrees.

4. The system according to claim 1, wherein, When the hollow needle is connected to the deflector component, the hollow needle undergoes elastic deformation.

5. The system according to claim 1, wherein, The indexing structure includes multiple radially extending protrusions.

6. The system according to claim 1, wherein, The deflector component includes a connector to which the needle guide is attached, wherein the alignment indexing portion is formed along the connector.

7. The system according to claim 6, wherein, The alignment indexing section is positioned along the proximal end of the connector.

8. The system according to claim 1, wherein, The alignment indexing portion can be releasably engaged with the indexing structure of the housing to resist longitudinal movement of the deflector component relative to the inserter, thereby preventing the deflector component from accidentally falling off.

9. The system according to claim 1, wherein, The one or more longitudinally extending grooves include one or more notches or slots.

10. The system according to claim 1, wherein, The longitudinally extending groove defines the needle guide's rotational orientation about the longitudinal axis at a predetermined angle.

11. An inserter device for deploying an intraocular shunt, the device comprising: A housing having a distal end and an indexing structure extending along the distal end; The splitter deployment mechanism is disposed within the housing; A deformable hollow needle, connected to the housing and the deployment mechanism, is used to deliver an intraocular shunt; and A deflector component releasably attached to the distal end of the housing, the deflector component including a coupling body, an alignment indexing portion, and a needle guide, the needle guide being positioned against a portion of the hollow needle to position the hollow needle in a flexural configuration, wherein the alignment indexing portion includes one or more longitudinally extending indexing protrusions that are indexed about a longitudinal axis at a predetermined angle relative to the needle guide and extend radially, and are releasably engaged with the indexing structure of the housing to define the rotational orientation of the needle guide relative to the housing and resist rotational movement of the deflector component relative to the housing.

12. The apparatus according to claim 11, wherein, The needle guide includes a curved portion that bends at an angle between 0 and 15 degrees.

13. The apparatus according to claim 11, wherein, The needle guide includes a curved portion bent at an angle between 4 and 6 degrees.

14. The apparatus according to claim 11, wherein, The needle guide includes a straight insertion portion and an angled deployment portion.

15. The apparatus according to claim 11, wherein, The indexing structure includes a plurality of longitudinally extending indexing grooves that extend radially relative to the housing.

16. The apparatus according to claim 11, wherein, The alignment indexing portion can be releasably engaged with the indexing structure of the housing to resist longitudinal movement of the deflector component relative to the inserter, thereby preventing the deflector component from accidentally falling off.

17. The apparatus according to claim 11, wherein, The longitudinally extending indexing protrusion defines the rotational orientation of the needle guide about the longitudinal axis at a predetermined angle.

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