Bimodal intraocular shunt inserter

Abstract

The inserter can include a needle, an actuation member, and a plunger assembly. The needle can have a lumen, and the plunger assembly can include a plunger and a plunger driver. The plunger can be at least partially disposed within the needle lumen, and the plunger can be configured to advance the shunt into the needle lumen upon release. The plunger driver can be coupled to a proximal end portion of the plunger. The plunger driver extends from a first length to a second length upon movement of the actuation member to advance a distal end portion of the plunger relative to the lumen from a first position to a second position.

Description

[Technical field]

[0001] The present invention relates to an intraocular shunt inserter and the use of the intraocular shunt inserter during a method for implanting an intraocular shunt in an eye.

[0002] REFERENCE TO RELATED APPLICATIONS This application is a claim of the benefit of U.S. Provisional Patent Application No. 62 / 979,353, filed February 20, 2020, which is incorporated by reference in its entirety. [Background technology]

[0003] Glaucoma is an eye disease that affects millions of people.Glaucoma is associated with an increase in intraocular pressure, which occurs either due to the failure of the eye's drainage system to properly remove aqueous humor from the anterior chamber of the eye, or due to the excessive production of aqueous humor by the ciliary body in the eye.As a result of the increase in aqueous humor and the resulting increase in intraocular pressure, irreversible damage to the optic nerve and retina may occur, which may lead to irreversible retinal damage and blindness.

[0004] Glaucoma can be treated in a variety of ways. In one method of treatment, drugs, such as beta-blockers or prostaglandins, are administered to the eye to either reduce the production of aqueous humor or increase the flow of aqueous humor from the anterior chamber of the eye. Glaucoma filtration surgery is a surgical procedure typically used to treat glaucoma. In this procedure, a shunt is placed in the eye to reduce intraocular pressure by creating a pathway for aqueous humor to drain from the anterior chamber of the eye. The shunt is typically positioned in the eye such that it creates a drainage pathway between the anterior chamber of the eye and the low pressure area. Such a fluid flow path allows aqueous humor to exit the anterior chamber.

[0005] The importance of lowering intraocular pressure in slowing the progression of glaucoma has been satisfactorily documented. When medical treatment fails or is not tolerated, surgical intervention is indicated. There are various surgical filtration methods that lower intraocular pressure by creating a fluid flow path between the anterior chamber and the subconjunctival tissue. In one particular method, an intraocular shunt is implanted by an inserter by directing a needle, which passes the shunt through the cornea, across the anterior chamber, through the trabecular mesh and sclera, and retains it in the subconjunctival space. See, for example, U.S. Pat. No. 6,544,249, U.S. Pat. App. Pub. No. 2008 / 0108933, and U.S. Pat. No. 6,007,511, each of which is incorporated herein by reference in its entirety.

[0006] Depending on the patient's needs and the treatment selected, clinicians can implant intraocular shunts using an ab externo or ab interno technique. In the ab externo approach, the clinician can approach inwardly through the conjunctiva and through the sclera, as described in applicant's published patent applications, including U.S. Pat. Nos. 10,470,927 and 10,463,537. In the ab interno approach, the clinician can approach through the cornea, across the anterior chamber, through the trabecular mesh and the sclera. [Prior art documents] [Patent documents]

[0007] [Patent Document 1] U.S. Patent No. 6,544,249 [Patent Document 2] US Patent Application Publication No. 2008 / 0108933 [Patent Document 3] U.S. Patent No. 6,007,511 [Patent Document 4] U.S. Pat. No. 10,470,927 [Patent Document 5] U.S. Pat. No. 10,463,537 Summary of the Invention [Problem to be solved by the invention]

[0008] In accordance with one aspect of some embodiments disclosed herein, the reality is that some clinicians prefer to reposition the shunt relative to the bevel of the needle in preparation for a procedure. For example, some clinicians prefer to position the shunt in one particular location relative to the bevel of the needle when implanting an intraocular shunt using an ab interno procedure, while others prefer to position the shunt in another location relative to the bevel of the needle when performing an ab externo procedure. Furthermore, certain anatomies, shunt types and / or materials, and / or procedures may require such repositioning to allow for the most advantageous delivery of the shunt.

[0009] Furthermore, in accordance with one aspect of some of the embodiments disclosed herein, there exists a real need for an intraocular shunt inserter that allows a clinician to quickly, reliably, and accurately reposition the shunt relative to the needle bevel according to his or her preferences to perform different procedures or approaches (e.g., ab externo or ab interno procedures) or in response to other shunt or patient factors and conditions. [Means for solving the problem]

[0010] The present invention therefore addresses these problems, provides a solution to these problems, and is directed to the discovery that operator effort, preparation time, cost, potential trauma to the patient, and surgical time can be reduced, and in some embodiments, precision can be increased while embodying certain advantageous features in a shunt inserter.

[0011] Some embodiments disclosed herein provide an intraocular shunt inserter having a component driver including an actuation member, where the component driver extends from a first length to a second length upon movement of the actuation member to change a relative longitudinal position of a distal end portion of a plunger or a distal end portion of a needle, the first length of the component driver being capable of positioning the shunt for an ab externo treatment, and the second length of the component driver being capable of positioning the shunt for an ab interno treatment.

[0012] The component drive may be coupled to, be part of, or control the movement or position of the inserter's plunger or needle. Optionally, the inserter may have two component drives, one coupled to, be part of, or control the movement or position of the plunger and another component drive coupled to, be part of, or control the movement or position of the inserter's needle.

[0013] Some embodiments disclosed herein provide an intraocular shunt inserter having a plunger driver coupled to a proximal end portion of a plunger, the plunger driver having an actuation member, the plunger driver extending from a first length to a second length upon movement of the actuation member to advance the shunt relative to a bevel of a needle, the first length of the plunger driver being capable of positioning the shunt for ab externo treatment and the second length of the plunger driver being capable of positioning the shunt for ab interno treatment.

[0014] Some embodiments disclosed herein provide an intraocular shunt inserter having a needle driver coupled to a proximal end portion of a needle, the needle driver including an actuation member, and a plunger driver that shortens from a first length to a second length upon movement of the actuation member to retract a bevel of the needle relative to the shunt, the first length of the needle driver can position the needle for ab externo treatment of the shunt, and the second length of the needle driver can position the needle for ab interno treatment of the shunt.

[0015] Optionally, the actuating member may include an oval cam rotatable within the body of the plunger driver about an axis oriented perpendicular to the longitudinal axis of the inserter. The oval cam may have a major axis and a minor axis, and the plunger driver extends from the first length to the second length by rotating the oval cam to align the major axis with the longitudinal axis of the inserter. The actuating member may positively displace the plunger driver from the first length to the second length.

[0016] Some embodiments disclosed herein provide an intraocular shunt inserter having a needle driver, a plunger driver, and an actuation mechanism that changes both the length of the needle driver and the length of the plunger driver to adapt the inserter to either an ab externo or an ab interno procedure. The plunger driver and the needle driver can move in opposite directions when actuated.

[0017] Optionally, the inserter may have a removable key that releasably engages the actuation member and may also prevent release of the shunt prior to intended use.

[0018] An operator can operate the inserter by moving the plunger driver actuation member to change the plunger driver from a first plunger driver length to a second plunger driver length to advance the shunt against the bevel of the needle.An operator can also operate the inserter by moving the needle driver actuation member to change the needle driver from the first needle driver length to the second needle driver length to move the bevel of the needle against the shunt.

[0019] Optionally, the operator can rotate one or more cam mechanisms to extend the plunger driver and / or retract the needle driver, thereby positioning the shunt against the bevel of the needle.

[0020] The accompanying drawings, which are provided to provide a further understanding of the present technology and are incorporated in and constitute a part of this specification, illustrate aspects of the invention and together with the specification, serve to explain the principles of the technology. [Brief description of the drawings]

[0021] [Figure 1] 1 is a schematic diagram of a procedure for implanting an intraocular shunt in an eye using an inserter, according to some embodiments. [Diagram 2] 1 is a perspective view of an inserter for implanting an ocular shunt in an eye, according to some embodiments. [Diagram 3] FIG. 3 is an exploded perspective view of the inserter shown in FIG. 2 according to some embodiments. [Figure 4] FIG. 3 is an exploded perspective view of a drive assembly of the inserter shown in FIG. 2 according to some embodiments. [Diagram 5] FIG. 5 is an exploded perspective view of the needle assembly and plunger assembly shown in FIG. 4, according to some embodiments. [Figure 6] FIG. 6 is an exploded perspective view of the needle assembly and plunger assembly shown in FIG. 5 in an actuated position, according to some embodiments. [Figure 7]FIG. 5 is a perspective view of the plunger assembly shown in FIG. 4 according to some embodiments. [Figure 8] 8 is an elevational view of the plunger driver shown in FIG. 7, according to some embodiments. [Figure 9] 9 is an elevational view of the plunger driver shown in FIG. 8 in an actuated position, according to some embodiments. [Figure 10] FIG. 5 is a perspective view of the needle assembly shown in FIG. 4, according to some embodiments. [Figure 11] FIG. 11 is an elevational view of the needle driver shown in FIG. 10, according to some embodiments. [Figure 12] FIG. 12 is an elevational view of the needle driver shown in FIG. 11 in an actuated position, according to some embodiments. [Figure 13] 1 is an elevational view of a rotatable key according to some embodiments. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0022] In the following detailed description, numerous specific details are set forth to provide a thorough understanding of the present technology. It should be understood that the present technology can be practiced without some of these specific details. In other instances, well-known structures and techniques have not been shown in detail in order not to obscure the present technology.

[0023] Glaucoma is a disease in which the optic nerve is damaged, causing progressive and irreversible vision loss. Glaucoma is typically associated with increased pressure of fluid within the eye (i.e., aqueous humor). If left untreated, glaucoma can cause permanent damage to the optic nerve, resulting in loss of vision and even blindness. Once blindness occurs, this impaired vision cannot be restored.

[0024] In the condition of glaucoma, the pressure of the aqueous humor in the eye (anterior chamber) increases, and the resulting increased pressure can cause damage to the vascular system at the back of the eye, particularly the optic nerve. Treatment of glaucoma and other diseases that result in increased pressure in the anterior chamber involves reducing the pressure in the anterior chamber to normal levels.

[0025] Glaucoma filtration surgery is a surgical procedure typically used to treat glaucoma. In this surgical procedure, a shunt is placed in the eye to lower intraocular pressure by creating a pathway for aqueous humor to drain from the anterior chamber of the eye. The shunt is typically positioned in the eye such that it creates a drainage pathway between the anterior chamber of the eye and the low pressure area. Various structures and / or areas of the eye with low pressure targeted for aqueous humor drainage include Schlemm's canal, subconjunctival space, episcleral vein, suprachoroidal space, intra-Tenon's adhesion space, and subarachnoid space. Shunts may be implanted using an ab externo approach (e.g., through the conjunctiva and approaching medially through the sclera) or an ab interno approach (e.g., through the cornea, across the anterior chamber, and approaching through the trabecular mesh and sclera). For example, ab externo techniques for implanting an intraocular shunt in the subconjunctival space are shown, for example, in Horvath et al. (U.S. Pat. No. 10,470,927) and Horvath et al. (U.S. Pat. Appl. Pub. No. 2017 / 0348150), each of which is incorporated by reference herein in its entirety. For example, ab interno techniques for implanting an intraocular shunt in the subconjunctival space are shown, for example, in Yu et al. (U.S. Pat. No. 6,544,249 and U.S. Pat. Appl. Pub. No. 2008 / 0108933) and Prywes (U.S. Pat. No. 6,007,511), each of which is incorporated by reference herein in its entirety.

[0026] In some methods, a hollow shaft configured to hold an ocular shunt may be inserted into the eye. In some embodiments, the hollow shaft may be a component of a deployment device capable of deploying the ocular shunt. The hollow shaft may be coupled to the deployment device or may be part of the deployment device itself. Deployment devices include, for example, those described in commonly owned U.S. Pat. Nos. 9,585,790, 8,721,792, 8,852,136, and U.S. Patent Publication No. 2012 / 0123434, filed Nov. 15, 2010, each of which is incorporated by reference in its entirety.

[0027] According to some embodiments, the inserter can be advanced into the eye in either an ab interno or ab externo manner. The shunt can then be deployed from the shaft into the eye so that the shunt forms a passageway from the anterior chamber into a low pressure area, such as Schlemm's canal, the subconjunctival space, the episcleral vein, the suprachoroidal space, the intra-Tenon's synechiae space, the subarachnoid space, or other areas of the eye. The hollow shaft is then withdrawn from the eye. Methods for delivering and implanting bioabsorbable or permanent tubes or shunts, as well as implantation devices for carrying out such methods, are generally disclosed in applicant's patent documents, including U.S. Patent Application Publication Nos. 2012 / 0197175, 2015 / 0011926, 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 by reference in its entirety.

[0028] Some methods may be performed by making an incision in the eye prior to insertion of the deployment tool. However, in some cases, such methods may be performed without making an incision in the eye prior to insertion of the deployment tool. In some embodiments, the shaft coupled to the deployment tool has a sharp point or tip. In some embodiments, the hollow shaft is a needle. An exemplary needle that can be used is commercially available from Terumo Medical Corp. (Elkington, MD). In some embodiments, the needle can have a hollow interior and a beveled tip, and the ocular shunt can be held within the hollow interior of the needle. In some embodiments, the needle can have a hollow interior and a triple ground point or tip.

[0029] Some methods can be performed without the need to remove an anatomical portion or feature of the eye, including, but not limited to, the trabecular mesh, iris, cornea, or fluid. Some methods can be performed without causing substantial ocular inflammation, such as subconjunctival blebbing or endophthalmitis. Some methods can be accomplished using an ab interno approach by inserting a hollow shaft configured to hold or carry an intraocular shunt as it is advanced through the cornea, across the anterior chamber, through the trabecular mesh, and into the conjunctiva or intra-Tenon's synechiae space. However, some methods can be performed using an ab externo approach.

[0030] In some procedures performed using the ab interno technique, the angle of entry into the cornea may be altered to affect optimal placement of the shunt within the intra-Tenon synechiae space. The hollow shaft may be inserted into the eye at an angle above or below the limbus, as opposed to a translimbal approach.

[0031] For example, the hollow shaft may be inserted at a distance of about 0.25 mm to about 3.0 mm above the limbus. The shaft may be inserted at a distance of about 0.5 mm to about 2.5 mm above the limbus. The shaft may also be inserted at a distance of about 1.0 mm to about 2.0 mm above the limbus, or at any particular value within these ranges. For example, the hollow shaft may be inserted at a distance of about 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.

[0032] An ab interno method or procedure may require or benefit from positioning the shunt differently relative to the bevel of the needle as compared to the position of the shunt for an ab externo procedure. For example, for an ab externo procedure, it may be beneficial for the distal end of the shunt to be positioned more proximal to the bevel of the needle than for an ab interno procedure. As discussed above, existing inserters may not be able to or may not easily reposition the shunt relative to the bevel of the needle that the clinician prepares for the ab externo and / or ab interno procedure. The present disclosure provides various embodiments of methods and devices that allow an operator to easily position the shunt relative to the bevel of the needle to configure the inserter for either an ab externo or ab interno procedure.

[0033] Furthermore, in some embodiments, positioning the shunt away from the limbus at the exit site, as provided by an entry angle above the limbus, allows access to many lymphatic pathways for drainage of aqueous humor, such as the episcleral lymphatic network, in addition to the conjunctival lymphatic system. A larger entry angle also results in a flatter placement within the intra-Tenon adhesion space, which results in less bending of the shunt.

[0034] In some embodiments, the depth of penetration into the Tenon's synechiae space may be important in performing some methods to ensure proper positioning and function of the intraocular shunt, as described in U.S. Patent No. 8,852,136, which is incorporated by reference in its entirety.

[0035] In some methods, the distal tip of the hollow shaft can penetrate the sclera and intra-Tenon adhesion space without puncturing, removing or causing significant tissue distortion of the surrounding ocular tissue. The shunt is then deployed from the shaft. Preferably, the distal portion of the hollow shaft (unlike the distal tip) penetrates completely into the intra-Tenon adhesion space and then the shunt is deployed from the hollow shaft.

[0036] According to some embodiments, the hollow shaft can have a flat bevel needle, for example a needle with a triple ground tip. The tip bevel can first penetrate the sclera and then into the Tenon's adhesion space by making a horizontal slit. In some methods, the needle can be advanced even further so that the entire flat bevel penetrates into the Tenon's adhesion space, thereby spreading the tissue and opening it to a full circular diameter.

[0037] Moreover, according to one aspect of some methods, the intra-Tenon passageway may be pressed open by a flattened bevel portion of the needle so that the material around the opening is stretched sufficiently to avoid pinching the shunt in that zone, thus preventing the shunt from breaking due to pinching or squeezing. The flattened bevel penetrates completely into the intra-Tenon adhesion space, resulting in less distortion and trauma to the local area, which, however, will eventually surround and conform to the shape of the shunt once it is deployed in the eye.

[0038] In some embodiments, the inserter can function as a one-handed instrument, the purpose of which is to allow the operator to keep his or her other hand on the fixation device, e.g., hook, that holds the eye. This can increase surgical control and placement precision, which also makes the surgery easier.

[0039] One example of a procedure for treating an eye 12 is shown in Figure 1. Figure 1 illustrates the use of a hook 14 to hold the eye 12 and an inserter 100 to introduce an intraocular shunt into the eye.

[0040] Described herein are embodiments of an intraocular shunt inserter. The shunt inserter may include a needle with a lumen. A plunger may be disposed partially within the lumen of the needle. The plunger may advance the shunt into the needle to introduce the intraocular shunt into the eye.

[0041] The component driver can have an actuation member that moves the plunger and / or needle to prepare the inserter for an ab externo or ab interno procedure. In some embodiments, the component driver can be actuated to change the position of the shunt relative to the bevel of the needle. The component driver can be coupled to, be part of, or can control the movement or position of the plunger or needle of the inserter.

[0042] For example, optionally, the component driver may extend or shorten from a first length to a second length to change the relative longitudinal position of the distal end portion of the plunger.

[0043] Further optionally, the component actuator may extend or shorten from a first length to a second length to change the relative longitudinal position of the distal end portion of the needle.

[0044] Optionally, the inserter may have two component drives, one component drive coupled to, part of, or controlling the movement or position of the plunger, and another component drive coupled to, part of, or controlling the movement or position of the needle of the inserter.

[0045] In some embodiments, the component driver can be coupled to the needle to vary the relative position of the distal end portion of the needle.In some embodiments, the component driver can be coupled to the plunger to vary the relative position of the distal end portion of the plunger.

[0046] 2-13 show further details of the inserter 100 shown in FIG. 1. The inserter 100 can be operated using one hand, thus facilitating use of the inserter by an operator. The inserter 100 can include an upper housing 102, a lower housing 104, a slider component 106, and a needle 121. As shown in FIG. 2, the inserter 100 can be configured such that the slider component 106 is slidable along an elongated slot 108 in the housing 102. The slider component 106 can be selectively movable by an operator to actuate movement of the components of the inserter 100.

[0047] For example, as the slider component 106 moves distally (i.e., toward the needle 121) along the slot 108, the slider component 106 can result in a shunt (not shown) being advanced into and, in some embodiments, expelled from the needle 121, or the slider component 106 can advance a shunt (not shown) into and, in some embodiments, expelled from the needle 121. According to some embodiments described further herein, movement of the slider component 106 can result in translational and / or rotational movement of components of the inserter 100. The sliding motion of the slider component 106 can be converted into rotational motion, which can then be converted into motion along the longitudinal axis of the inserter 100. One of the advantages of this innovative and complex motion conversion mechanism is that it enables embodiments of the inserter to provide precise and measurable motion of its components in a compact assembly.

[0048] In the illustrated embodiment, the inserter 100 can be configured for an ab externo procedure or an ab interno procedure prior to an implantation procedure by rotating the removable key 150. As described herein, the removable key 150 can be positioned in a vertical position (as shown in FIG. 2) to position the shunt relative to the needle 121 for an ab externo procedure. Similarly, the removable key 150 can be rotated or otherwise positioned in a horizontal position to move the shunt relative to the needle 121 for an ab interno procedure.

[0049] After the inserter 100 is configured for an ab externo or ab interno procedure, the removable key 150 can be removed or otherwise separated from the inserter 100. In some embodiments, the removable key 150 functions as an interlock to prevent actuation of the inserter 100 until the removable key 150 is removed. Optionally, the removable key 150 can prevent the slider 106 from advancing until the removable key 150 is removed from the inserter 100.

[0050] 3, a plunger 131 may be disposed within the needle 121 to advance the shunt for implantation. The needle 121 may comprise a 25 GA or 27 GA needle. The plunger 131 may be slidably movable within the lumen of the needle 121 along the longitudinal axis of the inserter 100. Additionally, the needle 121 may be slidably movable within the lumen of the sleeve component 115 along the longitudinal axis. In some embodiments, the needle 121 may be attached to the moveable needle base 110.

[0051] Each of the needle 121 and plunger 131 may be coupled to a respective drive component of a drive assembly 140 disposed within the housings 102, 104. When assembled, the inserter 100 may be configured such that the needle 121, plunger 131, and sleeve component 115 are aligned or coaxial with a longitudinal axis. Several drive assemblies for actuating the plunger and withdrawing the needle of the inserter are disclosed in U.S. patent application Ser. Nos. 13 / 336,803, 12 / 946,645, 12 / 620,564, 12 / 946,653, 12 / 946,565, and 11 / 711,805, as well as U.S. Patent No. 9,585,790, which are incorporated by reference in their entireties.

[0052] 3 and 4, the needle 121, plunger 131, and sleeve 115 may be operatively coupled to the drive assembly 140 and / or the housing 102. For example, the needle assembly 120 may operatively couple the needle 121 to the drive assembly 140. The needle assembly 120 may include a needle 121, a needle base 110, and a needle driver 122. In the illustrated embodiment, the needle 121 may be coupled to the needle base 110. The needle base 110 may be fixedly coupled to a proximal end portion of the needle 121 such that rotational and longitudinal movement of the needle 121 and the needle base 110 is limited or prevented. The needle base 110 may be housed within a distal end portion of the housing 102 when the inserter 100 is assembled. Additionally, as shown in FIG. 4 and described further below, the needle base 110 may be coupled to the drive assembly 140 via the needle driver 122.

[0053] 4, the plunger assembly 130 can operatively couple the plunger 131 to a drive assembly 140. The plunger assembly 130 can include a plunger 131 and a plunger driver 132. The plunger driver 132 can be securely coupled to a proximal end portion or a middle portion of the plunger 131 to limit or prevent rotational and longitudinal movement of the plunger 131 relative to the plunger driver 132. The plunger driver 132 can be coupled to a drive assembly 140, as shown in FIG. 4 and described further below.

[0054] Additionally, the sleeve component 115 may be coupled to a portion of the housings 102, 104. The sleeve 115 may be coupled to prevent rotational and longitudinal movement between the sleeve component 115 and the housings 102, 104.

[0055] As mentioned above, needle 121 and plunger 131 may be operatively coupled to drive assembly 140. Such coupling may occur via needle driver 122 and plunger driver 132. Needle driver 122 and plunger driver 132 may be coupled to one or more drive components that engage drive assembly 140 and housing 102.

[0056] According to some embodiments, the drive assembly 140 can be coupled to the needle 121 and plunger 131 to cause movement of the needle 121 and plunger 131 along a longitudinal axis relative to the housings 102, 104. For example, the drive assembly 140 can be configured to rotate or slide within the housing 102. The drive assembly 140 can independently or simultaneously transmit longitudinal or axial forces to the needle part 121 and / or plunger 131 along the longitudinal axis, resulting in movement of the needle 121 and plunger 131 along the longitudinal axis relative to the housings 102, 104.

[0057] As described herein, movement of the slider component 106 results in movement of the drive assembly 140, which in turn moves the components of the drive assembly 140 relative to the housings 102, 104. Some embodiments may be configured such that the slider component 106 can move or slide longitudinally along a longitudinal axis relative to the housings 102, 104 in order to drive or result in linear motion of the needle 121 and plunger 131, which in turn drives or results in linear motion of the shunt.

[0058] 4, the drive assembly 140 may include drive components 141a, 141b configured to engage the needle driver 122 and the plunger driver 132. In some embodiments, longitudinal or linear motion of the slider component 106 along the longitudinal axis may be translated to result in rotation of the drive components 141a and 141b of the drive assembly 140, which in turn may be translated to result in longitudinal or linear motion of the needle 121 and plunger 131 along the longitudinal axis relative to the housings 102, 104. According to some embodiments, the motion of the components along the longitudinal axis may be parallel to the longitudinal axis.

[0059] 4 also illustrates an embodiment of the drive components 141a, 141b. The drive components 141a, 141b may have a groove 143 that may be configured to mate with a corresponding protrusion (not shown) of the slider component 106. Additionally, the drive components 141a, 141b may further have first and second drive grooves 142, 144 that may be configured to slidingly engage corresponding protrusions of the needle driver 122 and the plunger driver 132. Thus, the slider component 106 may have a protrusion, the needle driver 122 may have a protrusion 125, and the plunger driver 132 may have a protrusion 135. This configuration of such slots or grooves and protrusions may facilitate the transfer of motion from the slider component 106 to the needle 121 and the plunger 131, respectively. Additionally, plunger driver 132 and needle driver 122 may have rounded bodies that contact and slide against the inner guide surfaces of drive components 141a, 141b when fitted within drive components 141a, 141b.

[0060] As described herein, a clinician can choose to implant a shunt using either an ab externo or ab interno approach using the inserter 100 depending on the patient's needs and other factors. With reference to FIG. 5, the inserter 100 can be configured to position the shunt within the needle 121 for either an ab externo or ab interno approach. As shown, the needle assembly 120 and / or plunger assembly 130 can be configured to adjust the position of the shunt for either an ab externo or ab interno approach prior to the implantation procedure.

[0061] In some embodiments, the needle assembly 120 and / or plunger assembly 130 may be partially elongated, shortened, or otherwise modified to adjust the relative position of the needle 121 and / or plunger 131, and therefore the relative position of the shunt for either the ab externo or ab interno approach. In the illustrated embodiment, the needle driver 122 and / or plunger driver 132 may be partially elongated, shortened, or otherwise modified to adjust the position of the shunt.

[0062] For example, as shown in FIG. 5, for an ab externo approach, the plunger driver 132 can be positioned in a retracted position and the needle driver 122 can be positioned in an extended position. In some embodiments, the plunger driver 132 can be retracted by about 0.25 mm relative to the extended configuration. Optionally, the plunger driver 132 can be retracted by about 0.05 mm, about 0.10 mm, about 0.15 mm, about 0.20 mm, about 0.30 mm, about 0.40 mm, or about 0.50 mm. In some embodiments, the needle driver 122 can be extended by about 1 millimeter relative to the retracted configuration. Optionally, the needle driver 122 can be extended by about 0.8 mm, about 0.9 mm, about 1.1 mm, about 1.2 mm, about 1.3 mm, or about 1.5 mm. By shortening the plunger driver 132 and extending the needle driver 122, the shunt can be repositioned proximally relative to the bevel of the needle 121. In the ab externo configuration, the tip of the plunger 131, and thus the shunt, can be positioned approximately 7 mm from the bevel of the needle 121. Optionally, the tip of the plunger 131 can be positioned approximately 4 mm, approximately 5 mm, approximately 6 mm, approximately 8 mm, approximately 9 mm, approximately 10 mm, or approximately 11 mm from the bevel of the needle 121 prior to actuation of the inserter 100. Upon actuation of the inserter 100, the plunger 131 can be advanced approximately 6 mm relative to the needle 121. In some embodiments, upon actuation of the inserter 100, the plunger 131 can be advanced approximately 4 mm, approximately 5 mm, approximately 6 mm, approximately 8 mm, approximately 9 mm, approximately 10 mm, or approximately 11 mm relative to the needle 121.

[0063] As shown in FIG. 6, the removable key 150 can be actuated to move the plunger driver 132 to an extended position and the needle driver 122 to a retracted position in accordance with the ab interno method. In some embodiments, the plunger driver 132 can be extended by about 0.25 mm relative to the retracted configuration. Optionally, the plunger driver 132 can be extended by about 0.05 mm, about 0.10 mm, about 0.15 mm, about 0.20 mm, about 0.30 mm, about 0.40 mm, or about 0.50 mm. In some embodiments, the needle driver 122 can be retracted by about 1 millimeter relative to the elongated configuration. Optionally, the needle driver 122 can be retracted by about 0.8 mm, about 0.9 mm, about 1.0 mm, about 1.1 mm, about 1.2 mm, about 1.3 mm, or about 1.5 mm. By extending the plunger driver 132 and shortening the needle driver 122, the shunt can be positioned distally to the ab externo shunt location. In the ab interno configuration, the plunger 131 and needle 121 can be extended and retracted, respectively, to advance the shunt relative to the needle 121 by approximately 1.25 mm, as compared to the ab externo configuration. Thus, in the ab interno configuration, the tip of the plunger 131, and thus the shunt, can be positioned approximately 5.75 mm from the bevel of the needle 121. Optionally, the tip of the plunger 131 can be positioned approximately 3 mm, approximately 4 mm, approximately 5 mm, approximately 5.5 mm, approximately 6 mm, approximately 7 mm, or approximately 8 mm from the bevel of the needle 121 prior to actuation of the inserter 100. Upon actuation of the inserter 100, the plunger 131 can be advanced approximately 6 mm relative to the needle 121. In some embodiments, when the inserter 100 is actuated, the plunger 131 can be advanced relative to the needle 121 by approximately 4 mm, approximately 5 mm, approximately 6 mm, approximately 8 mm, approximately 9 mm, approximately 10 mm, or approximately 11 mm.

[0064] As can be appreciated, the inserter 100 may exhibit a default configuration suitable for an ab externo or ab interno procedure, and the removable key 150 may be used to change the default configuration from the ab externo configuration to the ab interno configuration and vice versa.

[0065] Optionally, the removable key 150 can partially extend through the needle driver 122 and / or plunger driver 132 to prevent movement of the needle assembly 120 and / or plunger assembly 130 relative to the housings 102, 104 and prevent inadvertent release of the shunt. Thus, the removable key 150 can be utilized by a clinician to select a configuration for the inserter 100 and also to prevent release of the shunt until desired.

[0066] In some embodiments, the configuration of the inserter 100 can be changed by changing just the length of the needle assembly 120, by changing just the length of the plunger assembly 130, or by changing both the length of the needle assembly 120 and the length of the plunger assembly 130. In some embodiments, the lengths of the needle driver 122 and the plunger driver 132 can be changed in opposite or different directions to change the configuration of the inserter 100.

[0067] Optionally, the length of needle driver 122 and the length of plunger driver 132 can be changed simultaneously in one motion. In some embodiments, the mating configuration of needle driver 122 and plunger driver 132 allows removable key 150 to engage and actuate both needle driver 122 and plunger driver 132 in one motion while simultaneously adjusting the length or configuration of needle driver 122 and plunger driver 132.

[0068] As can be appreciated, needle driver 122 and / or plunger driver 132 can utilize any suitable mechanism to effect extension or shortening. As shown in Figures 5-11, needle driver 122 and plunger driver 132 can utilize a cam mechanism to adjust the length of needle assembly 120 and / or plunger assembly 130.

[0069] For example, the plunger assembly 130 allows force or motion from the drive assembly 140 to actuate the plunger 131 and thus the shunt. As shown in FIG. 7, the proximal end of the plunger 131 may be fixed to or otherwise coupled to a distal end 138 of the plunger driver 132. As described herein, the drive assembly 140 may engage and actuate the plunger driver 132 via a protrusion 135. The protrusion 135 may extend from a proximal end 137 of the plunger driver 132. Optionally, a rounded portion 136 allows the plunger driver 132 to slide freely and be alignable within the drive assembly 140.

[0070] In the illustrated embodiment, the cam mechanism 134 can extend or retract the plunger driver 132. In some embodiments, the cam mechanism 134 can move the distal end 138 of the plunger driver 132 further or closer to the proximal end 137. In some embodiments, the cam mechanism 134 has a rotatable generally oval shape with a major axis A and a minor axis B, such that the major axis A is longer than the minor axis B. As shown, the cam mechanism 134 can be rotated by a keyed slot 139. A removable key 150 can engage the keyed slot 139 to actuate the cam mechanism 134. Optionally, the keyed slot 139 can be aligned with the major axis A of the cam mechanism 134.

[0071] As shown, the cam mechanism 134 can be disposed within the bore 133. The bore 133 can extend at least partially through the plunger driver 132. As described herein, actuation of the cam mechanism 134 can positively displace the bore 133, thereby extending the plunger driver 132, or shortening the plunger driver 132. As shown in FIG. 8, rotation of the cam mechanism 134 within the bore 133 can align a major axis A of the cam mechanism 134 generally perpendicular to the length of the plunger driver 132, displacing the walls of the bore 133 (e.g., creating a bulge) and shortening the plunger driver 132. In some embodiments, the shortened position of the plunger driver 132 corresponds to an ab externo treatment.

[0072] As shown in FIG. 9, rotation of cam mechanism 134 within bore 133 aligns a longitudinal axis A of cam mechanism 134 in a direction generally parallel to the length of plunger driver 132, displacing the walls of bore 133 and extending plunger driver 132. In some embodiments, the extended position of plunger driver 132 corresponds to an ab interno treatment. In some embodiments, rotation or actuation of cam mechanism 134 does not elastically deform plunger driver 132. In other words, plunger driver 132 is not biased back to any particular length in the absence of actuation.

[0073] Similarly, the needle assembly 120 allows a force or motion from the drive assembly 140 to actuate the needle 121. As shown in FIG. 10, the proximal end of the needle 121 may be fixed or otherwise coupled to the distal end 128 of the needle driver 122. Optionally, the proximal end of the needle 121 may be attached to the needle base 110. The needle base 110 may engage the distal end of the needle driver 122. The proximal end 114 of the needle base 110 may have a "snap" fit or friction fit with the distal end 128 of the needle driver 122. The needle driver 122 may have a complementary or receiving hole at the distal end 128. Optionally, the needle base 110 may have a rotation adjustment feature 116 to allow the clinician to adjust the rotation of the bevel of the needle 121.

[0074] As described herein, the drive assembly 140 can engage and actuate the needle driver 122 via the protrusion 125. The protrusion 125 can extend from a proximal end 127 of the needle driver 122. Optionally, a rounded portion 126 allows the needle driver 122 to slide freely and be positionable within the drive assembly 140.

[0075] In the illustrated embodiment, the cam mechanism 124 can extend and retract the needle driver 122 to adjust the position of the needle bevel relative to the plunger 131 and thus the distal end of the shunt. In some embodiments, the cam mechanism 124 can move the distal end 128 of the needle driver 122 further or closer to the proximal end 127. In some embodiments, the cam mechanism 124 has a rotatable generally oval shape with a major axis C and a minor axis D, such that the major axis C is longer than the minor axis D. As shown, the cam mechanism 124 can be rotated by a keyed slot 129. A removable key 150 can engage the keyed slot 129 to actuate the cam mechanism 124. In some embodiments, the keyed slot 129 can be aligned with the major axis C (not shown) of the cam mechanism 124.

[0076] In some embodiments, the keyed slot 129 of the needle assembly 120 can be aligned with the keyed slot 139 of the plunger assembly 130 such that the removable key 150 can engage both the needle assembly 120 and the plunger assembly 130. Advantageously, the plunger assembly 130 and the needle assembly 120 can be configured simultaneously with a single movement or rotation of the removable key 150.

[0077] 5, needle driver 122 can have a body having a bore 123 therethrough. Cam mechanism 124 can be disposed through and rotatable within bore 123. As described herein, cam mechanism 124 can be actuable to positively displace bore 123, thereby causing needle driver 122 to extend or needle driver 122 to shorten.

[0078] 11, the cam mechanism 124 can be rotatable within the bore 123 to align a longitudinal axis C of the cam mechanism 124 in a direction generally parallel to the length of the needle driver 122, thereby displacing the walls of the bore 123 to extend the needle driver 122. In some embodiments, the extended position of the needle driver 122 corresponds to an ab externo procedure.

[0079] 12, the cam mechanism 124 can be rotatable within the bore 123 to align a longitudinal axis C of the cam mechanism 124 generally perpendicular to the length of the needle driver 122, thereby displacing the walls of the bore (e.g., creating a bulge), thereby shortening the needle driver 122. In some embodiments, the shortened position of the needle driver 122 corresponds to an ab interno treatment.

[0080] In some embodiments, rotation or actuation of cam mechanism 124 does not elastically deform needle driver 122. In other words, needle driver 122 is not biased back to any particular length in the absence of actuation.

[0081] As shown in FIG. 13, the removable key 150 can be used to actuate the needle assembly 120 and / or the plunger assembly 130. In some embodiments, the removable key 150 comprises the inserter 100. The removable key 150 has an extension portion 152 configured to mate with the slot 129 and / or the slot 139. The extension portion 152 can pass through both the slot 129 and the slot 139 to actuate both the needle assembly 120 and the plunger assembly 130 simultaneously. The body 158 of the removable key 150 can abut the housings 102, 104. In some embodiments, the surface 154 can contact the housings 102, 104. Optionally, wings 156 can extend from the body 158 of the removable key 150 to allow the clinician to easily rotate the removable key 150.

[0082] In addition to configuring the inserter 100 for ab externo and ab interno procedures as described herein, the removable key 150 can engage with the slots 129, 139 to prevent inadvertent actuation of the inserter 100. Optionally, the removable key 150 can engage with the needle assembly 120 and / or plunger assembly 130 to prevent the drive assembly 140 from actuating the needle assembly 120 and / or plunger assembly 130 relative to the housings 102, 104. Upon removal of the removable key 150 from the housings 102, 104, the drive assembly 140 can actuate the needle assembly 120 and / or plunger assembly 130.

[0083] Although the detailed description includes many details, these details should not be construed as limiting the scope of the present technology, but merely as illustrating various examples and various aspects of the present technology. It should be understood that the scope of the present technology includes other embodiments not described in detail above. Various other modifications, changes and variations can be made to the structure, operation and details of the method and apparatus of the present technology disclosed herein without departing from the scope of the present invention. Unless otherwise specified, when referring to an element in the singular form, this is not intended to mean "one and only one" but rather "one or more" unless expressly specified otherwise. In addition, it is not necessary for an apparatus or method to address every problem that can be solved by different embodiments of the present invention in order to be included within the scope of the present invention.

[0084] Description of the present technology as an embodiment Various examples of aspects of the present invention are described below as embodiment sections for convenience, which are provided by way of illustration and not as limitations of the technology.

[0085] [Embodiment 1] An intraocular shunt inserter for treating glaucoma comprising a needle with a lumen and a plunger assembly, the plunger assembly including a plunger at least partially disposed within the lumen of the needle, the plunger configured to advance a shunt through the lumen of the needle during deployment, the plunger driver including a plunger driver coupled to a proximal end portion of the plunger, the plunger driver having an actuating member, the plunger driver extending from a first length to a second length upon movement of the actuating member to advance a distal end portion of the plunger from a first position to a second position relative to the lumen.

[0086] [Embodiment 2] An inserter as described in embodiment 1, characterized in that the actuating member comprises an oval cam, the oval cam being rotatable within the plunger drive device about an axis oriented perpendicular to the longitudinal axis of the inserter.

[0087] [Embodiment 3] The inserter of embodiment 2, wherein the oval cam has a major axis and a minor axis, and the plunger drive extends from the first length to the second length by rotating the oval cam to align the major axis with the longitudinal axis of the inserter.

[0088] [Embodiment 4] An inserter described in any one of embodiments 1 to 3, characterized in that the actuating member actively displaces the plunger drive device from the first length to the second length.

[0089] [Embodiment 5] An inserter described in any one of embodiments 1 to 4, further comprising a removable key, the removable key releasably engaging with the actuating member to move the actuating member.

[0090] [Embodiment 6] The inserter according to embodiment 5, wherein the removable key is releasably engageable within the actuation member.

[0091] [Embodiment 7] An inserter described in any one of embodiments 1 to 6, characterized in that the first position of the plunger corresponds to ab externo treatment.

[0092] [Embodiment 8] An inserter described in any one of embodiments 1 to 7, characterized in that the second position of the plunger corresponds to ab interno treatment.

[0093] [Embodiment 9] An intraocular shunt inserter for treating glaucoma, comprising a housing and a needle assembly, the needle assembly including a needle extending at least partially beyond a distal portion of the housing, the needle having a lumen, the needle assembly including a needle driver coupled to a proximal end portion of the needle, the needle driver having an actuating member, the needle driver shortening from a first length to a second length upon movement of the actuating member to retract the distal end portion of the needle from a first position to a second position relative to the housing.

[0094] [Embodiment 10] The inserter of embodiment 9, wherein the actuating member comprises an oval cam, the oval cam being rotatable within the needle drive device about an axis oriented perpendicular to the longitudinal axis of the inserter.

[0095] [Embodiment 11] The inserter of embodiment 10, wherein the oval cam has a major axis and a minor axis, and the needle drive retracts from the first length to the second length by rotating the oval cam to align the minor axis with the longitudinal axis of the inserter.

[0096] [Embodiment 12] An inserter described in any one of embodiments 9 to 11, characterized in that the actuating member actively displaces the needle drive device from the first length to the second length.

[0097] [Embodiment 13] An inserter described in any one of embodiments 9 to 12, further comprising a removable key, the removable key releasably engaging with the actuating member to move the actuating member.

[0098] [Embodiment 14] The inserter of embodiment 13, wherein the removable key releasably engages the actuation member to prevent expulsion of the shunt.

[0099] [Embodiment 15] An inserter described in any one of embodiments 9 to 14, characterized in that the first position of the needle corresponds to ab-externo treatment.

[0100] [Embodiment 16] An inserter described in any one of embodiments 9 to 15, characterized in that the second position of the needle corresponds to ab interno treatment.

[0101] [Embodiment 17] An inserter described in any one of embodiments 9 to 16, further comprising a needle base connected to the proximal end portion of the needle, the needle base being connected to the needle drive device.

[0102] [Embodiment 18] An intraocular shunt inserter for treating glaucoma, comprising: a housing; a needle assembly at least partially disposed within the housing, the needle assembly including a needle and a needle driver coupled to a proximal end portion of the needle; the inserter having a plunger assembly at least partially disposed within the housing, the plunger assembly including a plunger and a plunger driver coupled to a proximal end portion of the plunger, the plunger being at least partially disposed within a lumen of the needle, the plunger being configured to advance a shunt into the lumen of the needle; and the inserter including a rotatable actuation mechanism to vary at least one of a length of the needle driver or a length of the plunger driver to enable a clinician to adapt the inserter to a given surgical procedure.

[0103] [Embodiment 19] The inserter of embodiment 18, wherein the plunger drive moves in an opposite direction to the needle drive upon movement of the actuation mechanism.

[0104] [Embodiment 20] The inserter of embodiment 19, wherein upon movement of the actuation mechanism, the plunger drive extends and the needle drive retracts.

[0105] [Embodiment 21] An inserter described in any one of embodiments 18 to 20, characterized in that the actuation mechanism actively displaces the needle drive device from a first length to a second length.

[0106] [Embodiment 22] An inserter described in any one of embodiments 18 to 21, further comprising a needle base connected to the proximal end portion of the needle, the needle base being connected to the needle drive device.

[0107] [Embodiment 23] An inserter described in any one of embodiments 18 to 22, characterized in that the actuation mechanism actively displaces the plunger drive device from a first length to a second length.

[0108] [Embodiment 24] An inserter described in any one of embodiments 18 to 23, further comprising a removable key, said removable key releasably engaging with an actuation mechanism to move said plunger drive device and said needle drive device simultaneously.

[0109] [Embodiment 25] The inserter according to embodiment 24, wherein said removable key releasably engages said actuation mechanism.

[0110] [Embodiment 26] An inserter according to any one of embodiments 18 to 25, characterized in that the plunger drive device is at least partially fitted within the needle drive device.

[0111] [Embodiment 27] An intraocular shunt inserter for treating glaucoma, comprising a needle having a lumen, a needle driver coupled to a proximal end portion of the needle, the inserter having a plunger assembly including a plunger disposed at least partially within the lumen of the needle, the plunger configured to advance a shunt into the lumen of the needle upon release, the inserter having a component driver having an actuating member, the component driver extending from a first length to a second length upon movement of the actuating member to change the longitudinal relative position of (i) a distal end portion of the plunger when coupled to the proximal end portion of the plunger, or (ii) a distal end portion of the needle when coupled to the proximal end portion of the needle.

[0112] [Embodiment 28] The inserter of embodiment 27, wherein the actuating member comprises an oval cam, the oval cam being rotatable within the component drive device about an axis oriented perpendicular to the longitudinal axis of the inserter.

[0113] [Embodiment 29] The inserter of embodiment 28, wherein the oval cam has a major axis and a minor axis, and the component drive extends from the first length to the second length by rotating the oval cam to align the major axis with the longitudinal axis of the inserter.

[0114] [Embodiment 30] An inserter described in any one of embodiments 27 to 29, further comprising a removable key, the removable key releasably engaging with the actuating member to move the actuating member.

[0115] [Embodiment 31] An inserter according to any one of embodiments 27 to 30, characterized in that the removable key is releasably engageable within the actuating member.

[0116] [Embodiment 32] An inserter described in any one of embodiments 27 to 31, further comprising a housing, wherein the needle or the plunger can be moved longitudinally from a first position to a second position relative to the distal portion of the housing.

[0117] [Embodiment 33] An inserter according to any one of embodiments 27 to 32, further comprising any one of the features according to any one of embodiments 1 to 26.

[0118] [Embodiment 34] An inserter described in any one of embodiments 27 to 33, characterized in that the component drive device is coupled to the proximal end portion of the needle.

[0119] [Embodiment 35] An inserter described in any one of embodiments 27 to 34, characterized in that the component drive device is coupled to the proximal end portion of the plunger.

[0120] [Embodiment 36] A method of operating an intraocular shunt inserter, the method comprising the steps of partially positioning a plunger within a needle lumen and moving a plunger driver actuation member to change the plunger driver from a first plunger driver length to a second plunger driver length, the plunger driver being coupled to a proximal end portion of the plunger.

[0121] [Embodiment 37] The method of embodiment 36, further comprising the step of moving a distal end portion of the plunger from a first plunger position to a second plunger position relative to the lumen prior to expelling the shunt through the lumen of the needle.

[0122] [Embodiment 38] The method described in embodiment 36 or 37, further comprising the step of moving a needle drive device actuation member to change the needle drive device from a first needle drive device length to a second needle drive device length, wherein the needle drive device is coupled to the proximal end portion of the plunger.

[0123] [Embodiment 39] The method of embodiment 38, further comprising the step of moving a distal end portion of the needle from a first needle position to a second needle position relative to the distal end portion of the plunger prior to expelling the shunt through the lumen of the needle.

[0124] [Embodiment 40] The method of embodiment 38 or 39, further comprising the step of simultaneously moving the plunger drive actuator actuating member and the needle drive actuator actuating member.

[0125] [Embodiment 41] A method according to any one of embodiments 38 to 40, further comprising the step of moving the plunger drive in a direction opposite to that of the needle drive during movement of the plunger drive actuating member and the needle drive actuating member.

[0126] [Embodiment 42] A method according to any one of embodiments 38 to 41, further comprising the steps of extending the plunger drive upon movement of the plunger drive actuating member, and retracting the needle drive upon movement of the needle drive actuating member.

[0127] [Embodiment 43] A method according to any one of embodiments 38 to 42, characterized in that the step of moving the needle drive device actuating member further includes the step of rotating an oval cam within the needle drive device about an axis oriented perpendicular to the longitudinal axis of the inserter.

[0128] [Embodiment 44] The method of embodiment 43, further comprising the step of rotating the oval cam to align its minor axis with the longitudinal axis of the inserter.

[0129] [Embodiment 45] A method according to any one of embodiments 38 to 44, further comprising the step of actively displacing the needle drive device from the first length to the second length.

[0130] [Embodiment 46] A method according to any one of embodiments 38 to 45, further comprising the step of releasably engaging the plunger drive device actuating member and the needle drive device actuating member with a removable key.

[0131] [Embodiment 47] The method of embodiment 46, further comprising the step of preventing release of the shunt by engaging the plunger driver actuation member and the needle driver actuation member with the removable key.

[0132] [Embodiment 48] A method according to any one of embodiments 36 to 47, characterized in that the step of moving the plunger drive actuator further includes the step of rotating an oval cam within the plunger drive about an axis oriented perpendicular to the longitudinal axis of the inserter.

[0133] [Embodiment 49] The method of embodiment 48, further comprising the step of rotating the oval cam to align its major axis with the longitudinal axis of the inserter.

[0134] [Embodiment 50] A method according to any one of embodiments 36 to 49, further comprising the step of actively displacing the plunger drive from the first length to the second length.

[0135] [Embodiment 51] A method for operating an intraocular shunt inserter, characterized in that the method includes any of the steps or features described in any one of embodiments 1 to 50.

[0136] [Embodiment 52] An intraocular shunt inserter, characterized in that it includes any one of the features described in any one of embodiments 1 to 50.

[0137] Further considerations In some embodiments, any of the embodiment clauses described herein may be dependent on any one of the independent embodiment clauses or any one of the dependent embodiment clauses. In one aspect, any of the embodiment clauses (e.g., dependent or independent embodiment clauses) may be combined with any one or more other embodiment clauses (e.g., dependent or independent embodiment clauses). In one aspect, a claim may include some or all of the terms (e.g., steps, operations, means, or components) described in a clause, sentence, phrase, or paragraph. In one aspect, a claim may include some or all of the terms described in one or more clauses, sentences, phrases, or paragraphs. In one aspect, some of the terms described in each clause, sentence, phrase, or paragraph may be omitted. In one aspect, additional terms or elements may be added to a clause, sentence, phrase, or paragraph. In one aspect, the technology may be practiced without utilizing some of the components, elements, functions, or operations described herein. In one aspect, the technology may be implemented using additional components, additional elements, additional functions, or additional operations.

[0138] When referring to an element in the singular, this does not mean one and only one, unless specifically stated otherwise, but rather means one or more. For example, "a" module may mean one or more modules. An element preceded by "a", "an", "the" or "said" does not exclude the presence of additional identical elements, unless otherwise constrained.

[0139] Headings and subheadings, if any, are used for convenience only and are not intended to limit the invention. The term "exemplary" is used to mean serving as an example or illustration. When terms such as "include," "have," and the like are used, such terms are intended to be as inclusive as "comprise," since "comprise," when used, is interpreted as a transitional phrase in the claims. Relationship terms, such as "first" and "second," may be used to distinguish one element or act from another, without necessarily requiring or implying such an actual relationship or order between such elements or acts.

[0140] For example, phrases such as one aspect, the above aspect, another aspect, some aspects, one or more aspects, one embodiment, the above embodiment, another embodiment, some embodiments, one or more embodiments, one embodiment, the above embodiment, another embodiment, some embodiments, one or more embodiments, one configuration, the above configuration, another configuration, some configurations, one or more configurations, the present technology, the present disclosure, the present invention, and other variations are for convenience and do not mean that the disclosure associated with such phrases is essential to the present technology or that such disclosure applies to all configurations of the present technology. The disclosure associated with such phrases may apply to all configurations or one or more configurations. The disclosure associated with such phrases may provide one or more examples. For example, the phrases one aspect or some aspects may mean one or more aspects, and vice versa, which also applies to other above-mentioned phrases.

[0141] The phrase "at least one of" following a list of items, when followed by the term "and" or "or" separating any of the items, modifies the list as a whole and not each member of the list. The phrase "at least one of" does not require the selection of at least one item; instead, the phrase can convey a meaning including at least one of any one of the items, and / or at least one of any combination of the items, and / or at least one of each of the items. As an example, each of the phrases "at least one of A, B, and C" or "at least one of A, B, or C" means A only, B only, or C only, any combination of A, B, and C, and / or at least one of each of A, B, and C.

[0142] It is understood that the particular order or hierarchy of steps, operations, or processes disclosed is an example of an example of an exemplary approach. It is understood that the particular order or hierarchy of steps, operations, or processes can be performed in different orders unless expressly specified otherwise. Some of the steps, operations, or processes can be performed simultaneously. The accompanying method claims present the various steps, operations, and process elements in a basic order, if any, and are not meant to be limited to the particular order or hierarchy presented. They can be performed serially, linearly, in parallel, or in different orders. It is to be understood that the instructions, operations, and systems described can generally be incorporated together in a single software / hardware product or packaged in multiple software / hardware products.

[0143] In one respect, the term "coupled" or the like may mean "directly coupled." In another respect, the term "coupled" or the like may mean "indirectly coupled."

[0144] For example, terms such as "top," "bottom," "front," "back," "side," "horizontal," and "vertical" do not refer to the usual gravitational coordinate system, but rather to an arbitrary coordinate system. Thus, such terms can be extended to "upward," "downward," "diagonal," or "horizontal" in the gravitational coordinate system.

[0145] The present disclosure is provided to enable those skilled in the art to implement the various aspects described herein. In some cases, well-known structures and components are shown in block diagram form to avoid obscuring the concepts of the present technology. The present disclosure provides various examples of the present technology, and the present technology is not limited to these examples. Various modifications to these aspects will be readily apparent to those skilled in the art, and the principles described herein may be applied to other aspects.

[0146] All structural and functional equivalents (known or later developed to become known to those of skill in the art) of the elements of the various aspects described throughout this disclosure are hereby expressly incorporated by reference, and such equivalents are encompassed by the claims. Moreover, no disclosure is herein made publicly available, regardless of whether such disclosure is expressly recited in the claims. No claim component is to be construed under the provisions of 35 U.S.C. § 112, sixth paragraph, unless the component is expressly recited using the phrase "means for" or, in the case of a method claim, unless the component is recited using the phrase "step for."

[0147] Herein, the title of the invention, background art, brief description of the drawings, abstract, and drawings are incorporated into this disclosure and are provided as illustrative examples of the disclosure, not as a limiting description. The present invention is provided with the understanding that they are not used to limit the scope or meaning of the invention as set forth in the claims. In addition, it will be appreciated that in the detailed description, other descriptions provide illustrative examples, and that various features have been grouped together in various embodiments for the purpose of facilitating understanding of the invention. The method of the invention should not be interpreted as reflecting an intention that the claimed invention requires more features than are expressly recited in each claim. To the contrary, as the claims reflect, the subject matter of the invention lies not in all features constituting a single disclosed structure or operation. Herein, the claims are incorporated into the detailed description, and the content of each claim stands as a separately claimed invention in its own right.

[0148] The subject matter of the claims is not intended to be limited to the aspects described herein, but is to be accorded the full scope consistent with the subject matter of the claims as expressed literally, including all equivalents available under law. Nonetheless, no claim is intended to include subject matter that fails to comply with applicable patent statutory requirements, and no claim should be so interpreted.

Claims

1. An intraocular shunt inserter (100) for treating glaucoma, comprising: A housing (102, 104), a needle assembly (120) at least partially disposed within said housing (102, 104), said needle assembly (120) including a needle (121) and a needle driver (122) coupled to a proximal end portion (137) of said needle (121); a plunger assembly (130) at least partially disposed within the housing (102, 104), the plunger assembly (130) including a plunger (131) and a plunger driver (132) coupled to a proximal end portion (137) of the plunger (131), the plunger (131) being at least partially disposed within a lumen of the needle (121), the plunger (131) being configured to advance a shunt into the lumen of the needle (121); An inserter having an actuation mechanism that is rotatable to vary at least one of the length of the needle driver (122) or the length of the plunger driver (132) to allow a clinician to adapt the inserter (100) to a given surgical procedure.

2. The inserter (100) of claim 1 , wherein the plunger driver (132) moves in an opposite direction to the needle driver (122) upon movement of the actuation mechanism.

3. The inserter (100) of claim 1 or 2, wherein upon movement of the actuation mechanism, the plunger driver (132) extends and the needle driver (122) retracts.

4. The inserter (100) of any one of claims 1 to 3, wherein the actuation mechanism includes an oval cam, the oval cam being rotatable within a body of the needle driver (122) about an axis oriented perpendicular to a longitudinal axis of the inserter (100).

5. 5. The inserter (100) of claim 1, wherein the actuation mechanism includes an oval cam, the oval cam being rotatable within a body of the plunger driver (132) about an axis oriented perpendicular to a longitudinal axis of the inserter (100).

6. 6. The inserter (100) of claim 1, wherein the actuation mechanism includes an oval cam having a major axis and a minor axis, and the length of the needle driver (122) and the length of the plunger driver (132) are changed by rotating the oval cam to align the major axis with a longitudinal axis of the inserter (100).

7. The inserter (100) of any one of claims 1 to 6, further comprising a removable key (150), said removable key (150) releasably engaging said actuation mechanism for moving said actuation mechanism.

8. 8. The inserter (100) of claim 1, wherein the needle driver (122) extends from a first length to a second length upon movement of the actuation mechanism to change a relative longitudinal position of (i) the distal end portion (138) of the plunger (131) when coupled to a proximal end portion (137) of the plunger (131), or (ii) the distal end portion (138) of the needle (121) when coupled to a proximal end portion (137) of the needle (121).

9. The inserter (100) of claim 7, wherein the removable key (150) is releasably engagable with the actuation mechanism.

10. The inserter (100) of any one of claims 1 to 9, wherein the needle (121) or the plunger (131) is longitudinally movable from a first position to a second position relative to a distal portion of the housing (102, 104).

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