Bimodal intraocular shunt inserter

Abstract

To reduce labor of an operator, a preparation time, costs, potential injury of a patient, and an operation time.SOLUTION: It is preferable that an inserter has a needle, an operation member, and a plunger assembly. It is preferable that the needle has a lumen, and the plunger assembly includes a plunger and a plunger drive device. It is preferable that the plunger is at least partially arranged in the inside of the lumen of the needle, and is configured to advance a shunt into the lumen of the needle at the time of discharge. It is preferable that the plunger drive device is connected to a proximal end portion of the plunger. The plunger drive device extends from a first length to a second length at the time of motion of the operation member in order to advance a distal end portion of the plunger from a first position to a second position with respect to the lumen.SELECTED DRAWING: Figure 2

Description

Technical Field

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

[0002] 〔CROSS-REFERENCE TO RELATED APPLICATIONS〕 This application claims the benefit of U.S. Provisional Patent Application No. 62 / 979,353, filed Feb. 20, 2020, which is hereby incorporated by reference in its entirety.

Background Art

[0003] Glaucoma is an eye disease that affects millions of people. Glaucoma is associated with an increase in intraocular pressure that results from either a dysfunction of the eye's drainage system for properly removing aqueous humor from the anterior chamber of the eye or an overproduction of aqueous humor by the ciliary body within the eye. As a result of the increased aqueous humor and the resulting increase in intraocular pressure, irreversible damage to the optic nerve and retina can occur, which can lead to irreparable retinal damage and blindness.

[0004] Glaucoma can be treated in a variety of ways. In one treatment method, a drug, such as a beta blocker or a prostaglandin, is 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, an intraocular shunt is placed within the eye to create a pathway for draining aqueous humor from the anterior chamber of the eye, thereby reducing intraocular pressure. The shunt is typically positioned within the eye such that it creates a drainage pathway between the anterior chamber of the eye and a low-pressure area. Through such a fluid flow path, aqueous humor can exit the anterior chamber.

[0005] The importance of lowering intraocular pressure in slowing the progression of glaucoma is well documented in the literature. When medical treatment fails or is unacceptable, surgical intervention is indicated. There are various surgical filtration methods for lowering intraocular pressure by creating a fluid flow path between the anterior chamber and the subconjunctival tissue. In one particular method, an intraocular shunt is implanted by an inserter by directing a needle, and the inserter passes the shunt through the cornea, across the anterior chamber, through the trabecular meshwork and the sclera, and holds it in the subconjunctival space. For this, reference may be made, for example, to U.S. Patent No. 6,544,249, U.S. Patent Application Publication No. 2008 / 0108933, and U.S. Patent No. 6,007,511. Each of these patent documents is hereby incorporated by reference in its entirety and made a part of this specification.

[0006] A clinician can implant an intraocular shunt using an ab externo (from the outside) or ab interno (from the inside) technique, depending on the patient's desires and the treatment selected. In the ab externo approach, the clinician can approach internally through the conjunctiva and then through the sclera, as described in the applicant's published patent documents including U.S. Patent No. 10,470,927 and U.S. Patent No. 10,463,537. In the ab interno approach, the clinician can approach through the cornea, across the anterior chamber, and through the trabecular meshwork and the sclera.

Prior Art Documents

Patent Documents

[0007]

Patent Document 1

Patent Document 2

Patent Document 3

Patent Document 4

Patent Document 5

Summary of the Invention

Problems to be Solved by the Invention

[0008] According to one aspect of some embodiments disclosed herein, in reality, some clinicians prefer to reposition a shunt relative to the bevel of a needle in preparation for surgery. For example, some clinicians prefer to position the shunt at a specific location relative to the bevel of the needle when implanting an intraocular shunt using an ab interno technique, while others prefer to position the shunt at a different location relative to the bevel of the needle when performing an ab externo technique. Further, in certain specific anatomical structures, shunt types and / or materials, and / or techniques, such repositioning may be necessary to enable the shunt to be inserted most advantageously.

[0009] Furthermore, according to one aspect of some embodiments disclosed herein, there is a reality that an intraocular shunt inserter is desired that enables a clinician to quickly, reliably, and accurately reposition a shunt relative to the bevel of a needle according to their preference in order to perform different surgical procedures or approaches (e.g., ab externo or ab interno techniques), or in response to other shunts or patient factors and conditions.

Means for Solving the Problems

[0010] Accordingly, the present invention relates to the finding that by considering these problems, providing solutions to these problems, and reducing the operator's effort, preparation time, cost, potential trauma to the patient, and surgical time, in some embodiments, certain advantageous features in the shunt inserter can be embodied while enhancing accuracy.

[0011] Some embodiments disclosed herein provide an intraocular shunt inserter having a component drive device that includes an actuating member, where the component drive device extends from a first length to a second length during movement of the actuating member to change the longitudinal relative position of a distal end portion of the plunger or a distal end portion of the needle. The first length of the component drive device can position the shunt for ab externo treatment, and the second length of the component drive device can position the shunt for ab interno treatment.

[0012] The component drive device can be coupled to, form a part of, or control the movement or position of the plunger or needle of the inserter. Optionally, the inserter can have two component drive devices, one component drive device being coupled to, forming a part of, or controlling the movement or position of the plunger, and the other component drive device being coupled to, forming a part of, or controlling the movement or position of the needle of the inserter.

[0013] Some embodiments disclosed herein provide an intraocular shunt inserter having a plunger drive device coupled to a proximal end portion of the plunger, the plunger drive device having an actuating member, the plunger drive device extending from a first length to a second length during movement of the actuating member to advance the shunt relative to the bevel of the needle. The first length of the plunger drive device can position the shunt for ab externo treatment, and the second length of the component drive device can position the shunt for ab interno treatment.

[0014] Some embodiments disclosed herein provide an intraocular shunt inserter having a needle drive device coupled to a proximal end portion of a needle, the needle drive device including an actuating member, and the plunger drive device shortening from a first length to a second length during movement of the actuating member to retract the bevel of the needle relative to the shunt. The first length of the needle drive device allows the needle to be positioned for ab-externo treatment of the shunt, and the second length of the needle drive device allows the needle to be positioned for ab-interno treatment of the shunt.

[0015] Optionally, the actuating member may include an oval cam that can rotate within the body of the plunger drive device 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 drive device 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 can actively displace the plunger drive device from the first length to the second length.

[0016] Some embodiments disclosed herein provide an intraocular shunt inserter having a needle drive device, a plunger drive device, and an actuating mechanism that varies both the length of the needle drive device and the length of the plunger drive device to adapt the inserter for either an ab-externo or an ab-interno procedure. The plunger drive device and the needle drive device can move in opposite directions during operation.

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

[0018] The operator can operate the inserter by moving the plunger drive assembly actuating member to change the plunger drive assembly from a first plunger drive assembly length to a second plunger drive assembly length, advancing the shunt relative to the bevel of the needle. The operator can also operate the inserter by moving the needle drive assembly actuating member to change the needle drive assembly from a first needle drive assembly length to a second needle drive assembly length, moving the bevel of the needle relative to the shunt.

[0019] Optionally, the operator can rotate one or more cam structures to extend the plunger drive assembly and / or retract the needle drive assembly, thereby positioning the shunt relative to the bevel of the needle.

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

Brief Description of the Drawings

[0021]

Figure 1

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DETAILED DESCRIPTION OF THE INVENTION

[0022] In the following detailed description, many specific details are set forth in order 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 well-known technologies have not been shown in detail so as 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 an increase in the pressure of the fluid within the eye (i.e., aqueous humor). If glaucoma is left untreated, the optic nerve can be permanently damaged, resulting in loss of the visual field and potentially blindness. Once blind, this impaired visual field cannot be restored.

[0024] In the pathological condition of glaucoma, the pressure of aqueous humor in the eye (anterior chamber) rises, and due to the resulting increased pressure, damage may occur to the vascular system in the posterior part of the eye, particularly the optic nerve. In the treatment of glaucoma and other diseases that cause an increase in the pressure within the anterior chamber, the pressure within the anterior chamber is reduced to normal levels.

[0025] Glaucoma filtration surgery is a surgical procedure typically used to treat glaucoma. In this surgical procedure, a shunt is placed intraocularly to create a pathway for draining aqueous humor from the anterior chamber of the eye, thereby reducing intraocular pressure. The shunt is typically positioned intraocularly such that it creates a drainage pathway between the anterior chamber of the eye and a low-pressure region. Various structures and / or regions of the eye targeted for aqueous humor drainage include Schlemm's canal, the subconjunctival space, the episcleral vein, the suprachoroidal space, the intra-Tenon's adhesion space, and the subarachnoid space. The shunt may be implanted using an ab-externo approach (e.g., approaching inwardly through the conjunctiva and then through the sclera) or an ab-interno approach (e.g., approaching through the cornea, across the anterior chamber, and through the trabecular meshwork and sclera). For example, the ab-externo approach of implanting an intraocular shunt into the subconjunctival space is shown, for example, in Horvath et al. (U.S. Patent No. 10,470,927) and Horvath et al. (U.S. Patent Application Publication No. 2017 / 0348150), each of these patent documents is incorporated herein by reference in its entirety. For example, the ab-interno approach of implanting an intraocular shunt into the subconjunctival space is shown, for example, in 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), each of these patent documents is incorporated herein by reference in its entirety.

[0026] In some methods, a hollow shaft configured to hold an intraocular shunt may be inserted into the eye. In some embodiments, the hollow shaft may be a component of a deployment instrument that can deploy the intraocular shunt. The hollow shaft may be coupled to the deployment instrument or may be part of the deployment instrument itself. Examples of deployment instruments include those described in U.S. Patent Nos. 9,585,790, 8,721,792, 8,852,136, and U.S. Patent Application Publication No. 2012 / 0123434, all of which are commonly owned by the same assignee, and each of these patent documents is hereby incorporated by reference in its entirety and made a part of this specification.

[0027] According to some embodiments, the inserter may be advanced into the eye either in an ab interno or ab externo manner. Thereafter, the shunt can be deployed from the shaft into the eye such that the shunt forms a passage from the anterior chamber to a low-pressure region, such as the Schlemm's canal, the subconjunctival space, the suprachoroidal vein, the suprachoroidal space, the intratendinous adhesion cavity, the subarachnoid space, or other regions 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 implanting instruments for performing such methods, are disclosed in the applicant's patent documents in their entirety, and such patent documents include 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, and each of these patent documents is hereby incorporated by reference in its entirety and made a part of this specification.

[0028] Some methods may be performed by creating an incision in the eye prior to insertion of the implant device. However, in some cases, such methods may be performed without creating an incision in the eye prior to insertion of the implant device. In some embodiments, the shaft coupled to the implant device has a sharp tip or distal end. In some embodiments, the hollow shaft is a needle. Exemplary needles that can be used are commercially available from Terumo Medical Corp. (located in Elkton, Maryland). In some embodiments, the needle preferably has a hollow interior and a beveled tip, and the intraocular shunt may be held within the hollow interior of the needle. In some embodiments, the needle may have a hollow interior and a triple ground tip or distal end.

[0029] Some methods can be performed without removing an anatomical part or feature of the eye, such anatomical parts or features including, but not limited to, the trabecular meshwork, iris, cornea, or aqueous humor. Some methods can be performed without causing substantial eye inflammation, such as subconjunctival bleb formation or endophthalmitis. Some methods can be achieved using an ab interno approach by inserting a hollow shaft configured to hold or carry the intraocular shunt as it is advanced through the cornea, across the anterior chamber, through the trabecular meshwork, and into the subconjunctival or sub-Tenon's capsule adhesion cavity. However, some methods can be performed using an ab externo approach.

[0030] In some methods performed using an ab interno approach, the entry angle into the cornea may be varied to affect the optimal placement of the shunt within the sub-Tenon's capsule adhesion cavity. The hollow shaft may be inserted into the eye at an angle above or below the limbus, as opposed to an approach through the limbus.

[0031] For example, it is preferable to insert the hollow shaft at a position about 0.25 mm to about 3.0 mm above the corneal limbus. The shaft may be inserted at a position about 0.5 mm to about 2.5 mm above the corneal limbus. Further, the shaft may be inserted at a position about 1.0 mm to about 2.0 mm above the corneal limbus, or at any specific value falling 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 from the corneal limbus.

[0032] The ab interno method or technique may or may benefit from the need to position the shunt differently with respect to the bevel of the needle as compared to the position of the shunt for the ab externo technique. For example, with respect to the ab externo technique, it may be beneficial if the distal end of the shunt is positioned more proximally to the bevel of the needle than in the case of the ab interno technique. As described above, existing inserters may not be able to reposition the shunt with respect to the bevel of the needle that the clinician prepares for ab externo and / or ab interno techniques, or may not be able to reposition it easily. The present disclosure provides various embodiments of methods and instruments that enable an operator to easily position the shunt with respect to the bevel of the needle and configure the inserter to suit either the ab externo technique or the ab interno technique.

[0033] Furthermore, in some embodiments, by disposing away from the corneal limbus at the exit site, as provided by the entry angle above the corneal limbus, access to many lymphatic channels for the drainage of aqueous humor, in addition to the conjunctival lymphatic system, for example, the suprachoroidal lymphatic network is possible. Also, a larger entry angle results in a flatter configuration within the Tenon's capsule adhesion cavity, and as a result, the degree of bending of the shunt is reduced.

[0034] As described in U.S. Patent No. 8,852,136, in some embodiments, the depth of penetration into the sub-Tenon's adhesion cavity may be important in implementing some methods to ensure proper positioning and functioning of the intraocular shunt. This U.S. Patent is hereby incorporated by reference in its entirety and made a part of this specification.

[0035] In some methods, the distal tip of the hollow shaft can penetrate the sclera and the sub-Tenon's adhesion cavity without causing perforation, removal, or significant tissue distortion of the surrounding eye tissue. Next, the shunt is deployed from the shaft. Preferably, the distal portion (different from the distal tip) of the hollow shaft fully enters the sub-Tenon's adhesion cavity, and then the shunt is deployed from the hollow shaft.

[0036] According to some embodiments, the hollow shaft may preferably have a flat bevel needle, such as a needle with a triple-ground tip. The tip bevel can first penetrate the sclera and then into the sub-Tenon's adhesion cavity by creating a horizontal slit. In some methods, the needle may be further advanced, such that the entire flat bevel enters the sub-Tenon's adhesion cavity, thereby spreading the tissue and opening it to a full circle diameter.

[0037] Furthermore, according to one aspect of some methods, the sub-Tenon's passage may preferably be opened by being pressed by the flat bevel portion of the needle, such that the material around the opening is sufficiently stretched to avoid pinching of the shunt in that zone, thus preventing the shunt from being damaged due to pinching or constriction. When the flat bevel fully enters the sub-Tenon's adhesion cavity, the distortion and trauma to the local area are on a small scale. However, this area will ultimately surround the shunt and conform to the shape of the shunt once the shunt is deployed into the eye.

[0038] In some embodiments, the inserter can function as a single-handed instrument, the purpose of which is to allow the operator to keep his other hand on a fixation instrument that holds the eye, such as a hook. This can enhance surgical control and placement accuracy, thereby also facilitating the surgery.

[0039] An example of a procedure for treating the eye 12 is shown in FIG. 1. FIG. 1 shows the use of a hook 14 for holding the eye 12 and an inserter 100 for introducing an intraocular shunt into the eye.

[0040] Embodiments of an intraocular shunt inserter are described herein. The shunt inserter may have a needle with a lumen. A plunger may be partially provided within the lumen of the needle. The plunger can advance the shunt into the needle to introduce the intraocular shunt into the eye.

[0041] The component drive device may have an actuating member that moves the plunger and / or the needle to prepare the inserter for an ab-externo or ab-interno procedure. In some embodiments, the component drive device may be actuated to vary the position of the shunt relative to the bevel of the needle. The component drive device may be coupled to, form part of, or be able to control the movement or position of the plunger or needle of the inserter.

[0042] For example, optionally, the component drive device may extend or contract from a first length to a second length to vary the longitudinal relative position of the distal end portion of the plunger.

[0043] Further optionally, the component drive device may extend or contract from a first length to a second length to vary the longitudinal relative position of the distal end portion of the needle.

[0044] Optionally, the inserter may have two component drivers, one of which is coupled to the plunger, forms part of it, or controls its movement or position, and the other component driver is coupled to the needle of the inserter, forms part of it, or controls its movement or position.

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

[0046] Figures 2 - 13 show further details of the inserter 100 shown in Figure 1. The inserter 100 may be operable with one hand, thus making it easier for an operator to use the inserter. The inserter 100 may have an upper housing 102, a lower housing 104, a slider component 106, and a needle 121. As shown in Figure 2, the inserter 100 may be configured such that the slider component 106 is slidable along the elongated slot 108 of the housing 102. The slider component 106 may be selectively movable by an operator to initiate movement of the components of the inserter 100.

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

[0048] In the illustrated embodiment, the inserter 100 can be configured for an ab-externo or ab-interno procedure by rotating a removable key 150 prior to the implantation procedure. As described herein, the removable key 150 may 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 may be rotated to a horizontal position or otherwise positioned to move the shunt relative to the needle 121 for an ab-interno procedure.

[0049] After configuring inserter 100 to an ab-externo or ab-interno procedure, it may be beneficial to remove or otherwise separate removable key 150 from inserter 100. In some embodiments, removable key 150 functions as an interlock to prevent operation of inserter 100 until removable key 150 is removed. Optionally, removable key 150 can prevent slider 106 from advancing until removable key 150 is removed from inserter 100.

[0050] As shown in FIG. 3, plunger 131 may be provided within needle 121 to advance a shunt for implantation. Needle 121 may consist of a 25GA or 27GA needle. Plunger 131 may be slidably movable within the lumen of needle 121 along the longitudinal axis of inserter 100. Further, needle 121 may be slidably movable within the lumen of sleeve component 115 along the longitudinal axis. In some embodiments, needle 121 may be attached to movable needle base 110.

[0051] Each of needle 121 and plunger 131 may be coupled to respective drive components of drive assembly 140 provided within housings 102, 104. When in an assembled state, inserter 100 may be configured such that needle 121, plunger 131, and sleeve component 115 are aligned or coaxial along the longitudinal axis. Several drive assemblies for actuating the plunger and withdrawing the needle of the inserter are disclosed in U.S. Patent Application 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 hereby incorporated by reference in their entireties and made a part of this specification.

[0052] Referring to FIGS. 3 and 4, the needle 121, the plunger 131, and the sleeve 115 may be operatively coupled to the drive assembly 140 and / or the housing 102. For example, the needle assembly 120 may be operatively coupled to the drive assembly 140 with the needle 121. The needle assembly 120 may include the needle 121, the needle base 110, and the needle drive device 122. In the illustrated embodiment, the needle 121 may be coupled to the needle base 110. The needle base 110 may be firmly coupled to the proximal end portion of the needle 121 such that the rotational and longitudinal movements between the needle 121 and the needle base 110 are restricted or blocked. The needle base 110 may be housed within the distal end portion of the housing 102 when the inserter 100 is assembled. Further, as shown in FIG. 4 and further described below, the needle base 110 may be coupled to the drive assembly 140 via the needle drive device 122.

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

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

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

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

[0057] As described herein, when the slider component 106 moves, as a result, the drive assembly 140 moves, whereby the components of the drive assembly 140 relative to the housings 102, 104 move. Some embodiments may be configured such that the slider component 106 can move longitudinally or slide along the longitudinal axis relative to the housings 102, 104, for the purpose of driving or resulting in the linear movement of the needle 121 and the plunger 131, and as a result, driving or resulting in the linear movement of the shunt.

[0058] As shown in FIG. 4, the drive assembly 140 may include drive components 141a, 141b configured to engage with the needle drive device 122 and the plunger drive device 132. In some embodiments, the longitudinal or linear movement of the slider component 106 along the longitudinal axis may be converted such that it results in rotation of the drive components 141a and 141b of the drive assembly 140, whereby this rotation may in turn be converted such that it results in longitudinal or linear movement of the needle 121 and the plunger 131 along the longitudinal axis relative to the housings 102, 104. According to some embodiments, the movement of the components along the longitudinal axis may be parallel to the longitudinal axis.

[0059] FIG. 4 also shows an embodiment of the drive components 141a, 141b. The drive components 141a, 141b may have grooves 143 that may be configured to mate with corresponding protrusions (not shown) of the slider component 106. Further, the drive components 141a, 141b may further have first and second drive grooves 142, 144 that may be configured to slidably engage with corresponding protrusions of the needle drive device 122 and the plunger drive device 132. Thus, the slider component 106 may have protrusions, the needle drive device 122 may have a protrusion 125, and the plunger drive device 132 may have a protrusion 135. This configuration of such slots or grooves and protrusions can facilitate the transmission of movement from the slider component 106 to each of the needle 121 and the plunger 131. Further, the plunger drive device 132 and the needle drive device 122 may have round bodies that slide in contact with and abut against the inner guiding surfaces of the drive components 141a, 141b when fitted within the drive components 141a, 141b.

[0060] As described herein, the clinician can select either an ab externo or an ab interno approach and implant the shunt using the inserter 100 according to the patient's desires and other factors. Referring to FIG. 5, the inserter 100 may be configured to position the shunt within the needle 121 according to an ab externo or an ab interno approach. As shown, the needle assembly 120 and / or the plunger assembly 130 may be configured to adjust the position of the shunt prior to the implantation procedure to make it suitable for an ab externo or an ab interno approach.

[0061] In some embodiments, the needle assembly 120 and / or the plunger assembly 130 may be extended, shortened, or otherwise changed to partially adjust the relative position of the needle 121 and / or the plunger 131 and, as a result, the relative position of the shunt for either an ab externo or an ab interno approach. In the illustrated embodiment, the needle drive device 122 and / or the plunger drive device 132 may be extended, shortened, or otherwise changed to adjust the position of the shunt.

[0062] For example, as shown in FIG. 5, for the ab-externo approach, the plunger drive 132 can be positioned in the retracted position and the needle drive 122 can be positioned in the extended position. In some embodiments, the plunger drive 132 may be retracted by about 0.25 mm relative to the extended configuration. Optionally, the plunger drive 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 drive 122 may be extended by about 1 millimeter relative to the retracted configuration. Optionally, the needle drive 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 retracting the plunger drive 132 and extending the needle drive 122, the shunt can be repositioned proximally relative to the bevel of the needle 121. In the ab-externo configuration, the plunger 131 and thus the tip of the shunt are preferably positioned about 7 mm from the bevel of the needle 121. Optionally, the tip of the plunger 131 can be positioned about 4 mm, about 5 mm, about 6 mm, about 8 mm, about 9 mm, about 10 mm, or about 11 mm from the bevel of the needle 121 prior to actuation of the inserter 100. During actuation of the inserter 100, the plunger 131 is preferably advanced about 6 mm relative to the needle 121. In some embodiments, during actuation of the inserter 100, the plunger 131 is preferably advanced by about 4 mm, about 5 mm, about 6 mm, about 8 mm, about 9 mm, about 10 mm, or about 11 mm relative to the needle 121.

[0063] As shown in FIG. 6, in accordance with the ab interno method, it is preferable to operate the removable key 150 to move the plunger drive device 132 to the extended position and move the needle drive device 122 to the retracted position. In some embodiments, it is preferable to extend the plunger drive device 132 by about 0.25 mm relative to the retracted form. Optionally, the plunger drive device 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, it is preferable to shorten the needle drive device 122 by about 1 millimeter relative to the elongated form. Optionally, the needle drive device 122 can be shortened 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 drive device 132 and shortening the needle drive device 122, the shunt can be positioned distally relative to the ab externo shunt position. In the ab interno form, the plunger 131 and the needle 121 are each preferably extended and retracted so as to advance the shunt by about 1.25 mm relative to the needle 121 as compared to the ab externo form. Thus, in the ab interno form, the tip of the plunger 131 and thus the shunt is preferably positioned about 5.75 mm from the bevel of the needle 121. Optionally, the tip of the plunger 131 is preferably positioned about 3 mm, about 4 mm, about 5 mm, about 5.5 mm, about 6 mm, about 7 mm, or about 8 mm from the bevel of the needle 121 prior to the operation of the inserter 100. During the operation of the inserter 100, the plunger 131 is preferably advanced about 6 mm relative to the needle 121. In some embodiments, during the operation of the inserter 100, the plunger 131 is preferably advanced by about 4 mm, about 5 mm, about 6 mm, about 8 mm, about 9 mm, about 10 mm, or about 11 mm relative to the needle 121.

[0064] To be understandable, the inserter 100 may preferably assume a default configuration suitable for ab-externo or ab-interno procedures. The removable key 150 can be used to change the default configuration from an ab-externo configuration to an ab-interno configuration and vice versa.

[0065] Optionally, the removable key 150 can be used to partially penetrate the needle drive 122 and / or the plunger drive 132 to prevent movement of the needle assembly 120 and / or the plunger assembly 130 relative to the housings 102, 104 and to prevent inadvertent release of the shunt. Thus, a clinician can use the removable key 150 to select the configuration of the inserter 100 and further prevent release of the shunt until desired.

[0066] In some embodiments, the configuration of the inserter 100 can be changed by changing only the length of the needle assembly 120, by changing only 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 drive 122 and the plunger drive 132 can be changed in opposite or different directions relative to each other to change the configuration of the inserter 100.

[0067] Optionally, the lengths of the needle drive 122 and the plunger drive 132 can be changed simultaneously in a single operation. In some embodiments, due to the mating configuration of the needle drive 122 and the plunger drive 132, the removable key 150 can engage and actuate both the needle drive 122 and the plunger drive 132 in a single operation, and at the same time, adjust the length or configuration of the needle drive 122 and the plunger drive 132.

[0068] As can be understood, the needle drive device 122 and / or the plunger drive device 132 can be extended or shortened using any suitable mechanism. As shown in FIGS. 5 to 11, the needle drive device 122 and the plunger drive device 132 can utilize a cam mechanism to adjust the length of the needle assembly 120 and / or the plunger assembly 130.

[0069] For example, with the plunger assembly 130, the force or movement from the drive assembly 140 can 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 the distal end 138 of the plunger drive device 132. As described herein, the drive assembly 140 can engage and actuate the plunger drive device 132 via the protrusion 135. The protrusion 135 may extend from the proximal end 137 of the plunger drive device 132. Optionally, with the rounded portion 136, the plunger drive device 132 can slide freely and can be aligned within the drive assembly 140.

[0070] In the illustrated embodiment, the cam mechanism 134 can expand and contract the plunger drive device 132. In some embodiments, the cam mechanism 134 can further move the distal end 138 of the plunger drive device 132 or move it closer to the proximal end 137. In some embodiments, the cam mechanism 134 is generally oval-shaped and rotatable with a major axis A and a minor axis B, and thus the major axis A is longer than the minor axis B. As shown, the cam mechanism 134 can be rotated by the key slot 139. The removable key 150 can engage the key slot 139 to actuate the cam mechanism 134. Optionally, the key slot 139 can be aligned with the major axis A of the cam mechanism 134.

[0071] As shown in the figure, the cam mechanism 134 may be provided within the hole 133. The hole 133 may extend at least partially through the plunger drive 132. As described herein, when the cam mechanism 134 is actuated, the hole 133 can be actively displaced, thereby extending or shortening the plunger drive 132. As shown in FIG. 8, when the cam mechanism 134 is rotated within the hole 133, the major axis A of the cam mechanism 134 is aligned in a direction generally perpendicular to the length of the plunger drive 132, displacing the wall of the hole 133 (e.g., creating a bulge) and shortening the plunger drive 132. In some embodiments, the shortened position of the plunger drive 132 corresponds to ab-externo treatment.

[0072] As shown in FIG. 9, when the cam mechanism 134 is rotated within the hole 133, the major axis A of the cam mechanism 134 is aligned in a direction generally parallel to the length of the plunger drive 132, displacing the wall of the hole 133 and extending the plunger drive 132. In some embodiments, the extended position of the plunger drive 132 corresponds to ab-interno treatment. In some embodiments, even when the cam mechanism 134 is rotated or actuated, the plunger drive 132 does not elastically deform. In other words, the plunger drive 132 is not biased to return to any particular length when no actuation occurs.

[0073] Similarly, the needle assembly 120 can actuate the needle 121 with the force or movement from the drive assembly 140. As shown in FIG. 10, the proximal end of the needle 121 may be fixed to 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 can be engaged with the distal end of the needle driver 122. The proximal end 114 of the needle base 110 can form a "snap" or friction fit relationship 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 rotational adjustment feature 116 to allow a 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 projection 125. The projection 125 may extend from the proximal end 127 of the needle driver 122. Optionally, the round portion 126 allows the needle driver 122 to slide freely and be alignable within the drive assembly 140.

[0075] In the illustrated embodiment, the cam mechanism 124 can expand and contract 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 further move the distal end 128 of the needle driver 122 or move it near the proximal end 127. In some embodiments, the cam mechanism 124 is generally oval in shape with a major axis C and a minor axis D, and thus the major axis C is longer than the minor axis D. As shown, the cam mechanism 124 can be rotated by the keyed slot 129. The 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] As shown in FIG. 5, the needle drive 122 may have a body through which a hole 123 is provided. The cam mechanism 124 may be disposed through the hole 123 and may be rotatable therein. As described herein, the cam mechanism 124 is operable to actively displace the hole 123, whereby the needle drive 122 can be extended or the needle drive 122 can be shortened.

[0078] In some embodiments, as shown in FIG. 11, the cam mechanism 124 may be rotatable within the hole 123 such that the major axis C of the cam mechanism 124 is aligned generally parallel to the length of the needle drive 122, whereby the wall of the hole 123 can be displaced to extend the needle drive 122. In some embodiments, the extended position of the needle drive 122 corresponds to an ab-externo procedure.

[0079] As shown in FIG. 12, the cam mechanism 124 may be rotatable within the hole 123 such that the major axis C of the cam mechanism 124 is aligned generally perpendicular to the length of the needle drive 122, whereby the wall of the hole can be displaced (e.g., creating a bulge) to shorten the needle drive 122. In some embodiments, the shortened position of the needle drive 122 corresponds to an ab-interno treatment.

[0080] In some embodiments, depending on the rotation or actuation of the cam mechanism 124, the needle drive 122 does not elastically deform. In other words, the needle drive 122 is not biased to return to any particular length when not actuated.

[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 152 configured to mate with the slot 129 and / or the slot 139. The extension 152 can pass through both the slot 129 and the slot 139 to simultaneously actuate both the needle assembly 120 and the plunger assembly 130. The body 158 of the removable key 150 may abut the housings 102, 104. In some embodiments, the surface 154 may contact the housings 102, 104. Optionally, the wings 156 may extend from the body 158 of the removable key 150, thereby allowing the clinician to easily rotate the removable key 150.

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

[0083] The detailed description includes many details, but these details should not be construed as limiting the scope of the present technology and should be construed as merely explaining various embodiments 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. Without departing from the scope of the present invention, various other modifications, changes, and variations can be made to the configuration, operation, and details of the methods and apparatuses of the present technology disclosed herein. Unless otherwise specified, when referring to an element in the singular, this does not mean "one and only one" without an express additional specification, but rather "one or more". Additionally, it is not necessary for an instrument 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 item For the sake of convenience, various embodiments of the aspects of the present invention are described below as implementation mode items. These are provided by way of example and do not limit the present technology.

[0085] 〔Implementation Mode Item 1〕An intraocular shunt inserter for treating glaucoma, comprising a needle having a lumen and a plunger assembly, the plunger assembly including a plunger provided at least partially within the lumen of the needle, the plunger being configured to advance a shunt through the lumen of the needle during deployment, the plunger drive device including a plunger drive device coupled to a proximal end portion of the plunger, the plunger drive device having an actuating member, the plunger drive device being characterized in that it extends from a first length to a second length during movement of the actuating member to advance a distal end portion of the plunger from a first position to a second position with respect to the lumen.

[0086] [Embodiment Item 2] The operating member is composed of an oval cam, and the oval cam is rotatable in the plunger driving device around an axis directed perpendicular to the longitudinal axis of the inserter. The inserter according to Embodiment Item 1, characterized in that.

[0087] [Embodiment Item 3] The oval cam has a major axis and a minor axis, and the plunger driving device rotates the oval cam to align the major axis with the longitudinal axis of the inserter, thereby extending from the first length to the second length. The inserter according to Embodiment Item 2, characterized in that.

[0088] [Embodiment Item 4] The operating member actively displaces the plunger driving device from the first length to the second length. The inserter according to any one of Embodiment Items 1 to 3, characterized in that.

[0089] [Embodiment Item 5] Further having a removable key, the removable key releasably engages with the operating member to move the operating member. The inserter according to any one of Embodiment Items 1 to 4, characterized in that.

[0090] [Embodiment Item 6] The removable key is removably engagable within the operating member. The inserter according to Embodiment Item 5, characterized in that.

[0091] [Embodiment Item 7] The first position of the plunger corresponds to ab externo treatment. The inserter according to any one of Embodiment Items 1 to 6, characterized in that.

[0092] [Embodiment Item 8] The second position of the plunger corresponds to ab interno treatment. The inserter according to any one of Embodiment Items 1 to 7, characterized in that.

[0093] [Embodiment Item 9] An intraocular shunt inserter for treating glaucoma, comprising a housing and a needle assembly, wherein the needle assembly includes a needle extending at least partially beyond the distal portion of the housing, the needle has a lumen, the needle assembly includes a needle drive device coupled to the proximal end portion of the needle, the needle drive device has an actuating member, and the needle drive device is characterized in that when the actuating member moves to retract the distal end portion of the needle from a first position to a second position with respect to the housing, it shortens from a first length to a second length.

[0094] [Embodiment Item 10] The inserter according to Embodiment Item 9, wherein the actuating member is formed of an oval cam, and the oval cam is rotatable within the needle drive device about an axis oriented perpendicular to the longitudinal axis of the inserter.

[0095] [Embodiment Item 11] The inserter according to Embodiment Item 10, wherein the oval cam has a major axis and a minor axis, and the needle drive device 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 Item 12] The inserter according to any one of Embodiment Items 9 to 11, wherein the actuating member actively displaces the needle drive device from the first length to the second length.

[0097] [Embodiment Item 13] Further having a removable key, the removable key being releasably engageable with the actuating member to move the actuating member, the inserter according to any one of Embodiment Items 9 to 12.

[0098] [Embodiment Item 14] The inserter according to Embodiment Item 13, wherein the removable key is releasably engageable with the actuating member to prevent the release of the shunt.

[0099] 〔Embodiment Item 15〕The inserter according to any one of Embodiment Items 9 to 14, wherein the first position of the needle corresponds to ab externo treatment.

[0100] 〔Embodiment Item 16〕The inserter according to any one of Embodiment Items 9 to 15, wherein the second position of the needle corresponds to ab interno treatment.

[0101] 〔Embodiment Item 17〕The inserter according to any one of Embodiment Items 9 to 16, further comprising a needle base coupled to the proximal end portion of the needle, wherein the needle base is coupled to the needle driving device.

[0102] 〔Embodiment Item 18〕An intraocular shunt inserter for treating glaucoma, comprising a housing and a needle assembly at least partially provided within the housing, the needle assembly including a needle and a needle driving device coupled to the proximal end portion of the needle, the inserter having a plunger assembly at least partially provided within the housing, the plunger assembly including a plunger and a plunger driving device coupled to the proximal end portion of the plunger, the plunger being at least partially provided within the lumen of the needle, the plunger being configured to advance a shunt into the lumen of the needle, the inserter including a rotatable actuating mechanism for varying at least one of the length of the needle driving device or the length of the plunger driving device to enable a clinician to adapt the inserter to a given surgical procedure.

[0103] 〔Embodiment Item 19〕The inserter according to Embodiment Item 18, wherein the plunger driving device moves in a direction opposite to the needle driving device when the actuating mechanism moves.

[0104] 〔Embodiment Item 20〕The inserter according to Embodiment Item 19, wherein the plunger driving device extends and the needle driving device retracts when the actuating mechanism moves.

[0105] 〔Embodiment Item 21〕The inserter according to any one of Embodiment Items 18 to 20, wherein the operating mechanism actively displaces the needle driving device from a first length to a second length.

[0106] 〔Embodiment Item 22〕The inserter according to any one of Embodiment Items 18 to 21, further comprising a needle base coupled to the proximal end portion of the needle, wherein the needle base is coupled to the needle driving device.

[0107] 〔Embodiment Item 23〕The inserter according to any one of Embodiment Items 18 to 22, wherein the operating mechanism actively displaces the plunger driving device from a first length to a second length.

[0108] 〔Embodiment Item 24〕The inserter according to any one of Embodiment Items 18 to 23, further comprising a removable key, wherein the removable key releasably engages with the operating mechanism so as to move the plunger driving device and the needle driving device simultaneously.

[0109] 〔Embodiment Item 25〕The inserter according to Embodiment Item 24, wherein the removable key releasably engages with the operating mechanism.

[0110] 〔Embodiment Item 26〕The inserter according to any one of Embodiment Items 18 to 25, wherein the plunger driving device is at least partially fitted into the needle driving device.

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

[0112] [[Embodiment Item 28]]The inserter according to Embodiment Item 27, characterized in that the actuating member consists of an oval cam, and the oval cam is rotatable within the component driving device about an axis directed perpendicular to the longitudinal axis of the inserter.

[0113] [[Embodiment Item 29]]The inserter according to Embodiment Item 28, characterized in that the oval cam has a major axis and a minor axis, and the component driving device 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 Item 30]]The inserter according to any one of Embodiment Items 27 to 29, further having a removable key, the removable key being releasably engageable with the actuating member to move the actuating member.

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

[0116] [[Embodiment Item 32]] An inserter according to any one of Embodiment Items 27 to 31, further comprising a housing, wherein the needle or the plunger is longitudinally movable from a first position to a second position with respect to the distal portion of the housing.

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

[0118] [[Embodiment Item 34]] An inserter according to any one of Embodiment Items 27 to 33, wherein the component driving device is coupled to the proximal end portion of the needle.

[0119] [[Embodiment Item 35]] An inserter according to any one of Embodiment Items 27 to 34, wherein the component driving device is coupled to the proximal end portion of the plunger.

[0120] [[Embodiment Item 36]] A method of operating an intraocular shunt inserter, the method comprising: partially disposing a plunger within the lumen of a needle; and moving an actuator member of a plunger driving device to change the plunger driving device from a first plunger driving device length to a second plunger driving device length, wherein the plunger driving device is coupled to the proximal end portion of the plunger.

[0121] [[Embodiment Item 37]] The method according to Embodiment Item 36, further comprising moving a distal end portion of the plunger from a first plunger position to a second plunger position with respect to the lumen before releasing a shunt through the lumen of the needle.

[0122] 〔Embodiment Item 38〕The method according to Embodiment Item 36 or 37, further comprising the step of moving the needle drive device actuating 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 Item 39〕The method according to Embodiment Item 38, further comprising the step of moving the 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 before discharging the shunt through the lumen of the needle.

[0124] 〔Embodiment Item 40〕The method according to Embodiment Item 38 or 39, further comprising the step of simultaneously moving the plunger drive device actuating member and the needle drive device actuating member.

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

[0126] 〔Embodiment Item 42〕The method according to any one of Embodiment Items 38 to 41, further comprising the step of extending the plunger drive device during the movement of the plunger drive device actuating member and the step of retracting the needle drive device during the movement of the needle drive device actuating member.

[0127] 〔Embodiment Item 43〕The method according to any one of Embodiment Items 38 to 42, wherein the step of moving the needle drive device actuating member further comprises 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 Item 44〕The method according to Embodiment Item 43, further comprising the step of rotating the oval cam to align the minor axis with the longitudinal axis of the inserter.

[0129] 〔Embodiment Item 45〕The 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 Item 46〕The 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 Item 47〕The method according to Embodiment Item 46, further comprising the step of preventing the release of the shunt by engaging the plunger drive device actuating member and the needle drive device actuating member with the removable key.

[0132] 〔Embodiment Item 48〕The method according to any one of Embodiments 36 to 47, wherein the step of moving the plunger drive device actuating member further comprises the step of rotating the oval cam within the plunger drive device about an axis directed perpendicular to the longitudinal axis of the inserter.

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

[0134] 〔Embodiment Item 50〕The method according to any one of Embodiments 36 to 49, further comprising the step of actively displacing the plunger drive device from the first length to the second length.

[0135] 〔Embodiment Item 51〕A method of operating an intraocular shunt inserter, the method comprising any one of the steps or features described in any one of Embodiment Items 1 to 50.

[0136] 〔Embodiment Item 52〕An intraocular shunt inserter, the inserter comprising any one of the features described in any one of Embodiment Items 1 to 50.

[0137] Further considerations In some embodiments, any one of the embodiment items described herein can be dependent on any one of the independent form embodiment items or any one of the dependent form embodiment items. In one aspect, any one of the embodiment items (e.g., a dependent form or independent form embodiment item) can be combined with any one or more other embodiment items (e.g., a dependent form or independent form embodiment item). In one aspect, the claims can include some or all of the terms (e.g., steps, operations, means or components) described in a section, a paragraph, a clause, or a sentence. In one aspect, the claims can include some or all of the terms described in one or more sections, one or more paragraphs, one or more clauses or one or more sentences. In one aspect, some of the terms described in each of the sections, paragraphs, clauses or sentences can be omitted. In one aspect, additional terms or elements can be added to a section, a paragraph, a clause or a sentence. In one aspect, the present technology can be implemented without using some of the components, elements, functions or operations described herein. In one aspect, the present technology can 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 without further specific designation, but rather, in contrast, means one or more. For example, the "a" module may mean one or more modules. Elements positioned after "a", "an", "the" or "said" do not, without further constraints, preclude the existence of additional identical elements.

[0139] Headings and subheadings, if any, are used for convenience only and do not limit the present invention. The term "exemplary" is used to mean serving as an example or a specific instance. When terms such as the original term "include" (often translated as "comprising" in the translation), "have" (often translated as "having" in the translation), etc. are used, such terms are intended to be as inclusive as "comprise" (often translated as "comprising" in the translation), because "comprise", when used, is interpreted as a transitional phrase in the claims. Relational terms such as "first" and "second" may be used to distinguish one element or act from another element or act, in which case such terms do not necessarily require or imply any actual such relationship or order between such elements or acts.

[0140] For example, terms such as "from one perspective", "from the above perspective", "from another perspective", "from several perspectives", "from one or more perspectives", "one specific example", "the above specific example", "another specific example", "several specific examples", "one or more specific examples", "one embodiment", "the above embodiment", "another embodiment", "several embodiments", "one or more embodiments", "one configuration", "the above configuration", "another configuration", "several configurations", "one or more configurations", "the present technology", "the present disclosure", "the present invention", and other variations are for convenience, and the disclosure associated with such terms does not mean that it is essential for the present technology or that such disclosure applies to all configurations of the present technology. The disclosure associated with such terms may apply to all configurations or one or more configurations. The disclosure associated with such terms can provide one or more examples. For example, the terms "from one perspective" or "from several perspectives" may mean "from one or more perspectives", and vice versa, and this also applies to the other above-mentioned terms.

[0141] The expression "at least one of" following a series of items modifies the list as a whole rather than each member of the list when accompanied by the terms "and" or "or" to separate any of these items. The expression "at least one of" does not require the selection of at least one item. Instead, this expression can mean 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 expressions "at least one of A, B, and C" or "at least one of A, B, or C" means 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.

[0142] Needless to say, the specific order or hierarchy of the disclosed steps, operations, or processes is an example of an exemplary approach. It goes without saying that, without separate explicit designation, the specific order or hierarchy of steps, operations, or processes can be implemented in a different order. Some of the steps, operations, or processes can be executed simultaneously. The appended method claims, even if any, present the various steps, various operations, and elements of various processes in a basic order and do not mean to be limited to the specific order or hierarchy presented. These can be implemented serially, linearly, in parallel, or in a different order. It should be understood that the described instructions, operations, and systems can generally be incorporated together into a single software / hardware product or packaged into multiple software / hardware products.

[0143] In one aspect, terms such as "coupled" may mean "directly coupled". In another aspect, terms such as "coupled" may mean "indirectly coupled".

[0144] For example, terms such as "top", "bottom", "front side", "rear side", "side", "horizontal", "vertical", etc. do not mean the normal gravity coordinate system but an arbitrary coordinate system. Thus, such terms can be extended to "above", "below", "diagonal", or "horizontal" in the gravity coordinate system.

[0145] This 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 the form of block diagrams to avoid obscuring the concepts of the technology. This disclosure provides various embodiments of the technology, and the technology is not limited to these embodiments. Various modifications to these aspects will be readily apparent to those skilled in the art, and the principles described herein can be applied to other aspects.

[0146] All structural and functional equivalents of the elements of the various aspects described throughout this disclosure (known to those of ordinary skill in the art or later to become known to those of ordinary skill in the art) are hereby incorporated by reference and made an explicit part of this specification, and such equivalents are included in the claims. Further, nothing in this specification is to be considered as disclosed to the public, whether or not explicitly recited in the claims, that is not already disclosed. There are no claim components to be construed under the provisions of 35 U.S.C. § 112, paragraph 6, provided that the component is not explicitly recited using the phrase "means for", or in the case of a method claim, provided that the component is not recited using the phrase "step for".

[0147] Herein, the title of the invention, the background art, the brief description of the drawings, the abstract, and the drawings are incorporated into the present disclosure and provided as illustrative examples of the present disclosure rather than as limiting descriptions. The present invention is provided with the understanding that it is not used to limit the scope or meaning of the present invention as recited in the claims. Additionally, in the detailed description, it can be seen that other descriptions provide illustrative examples and various features are gathered in various embodiments for the purpose of facilitating the understanding of the present invention. The method of the present invention should not be construed as reflecting an intention that the claimed invention requires more features than those explicitly recited in each claim. Instead, as the claims reflect, the gist of the present invention does not lie in all the features that make up a single disclosed configuration or operation. Herein, the claims are incorporated into the detailed description and the content of each claim stands on its own as a separately claimed invention.

[0148] The content of the claims is not intended to be limited to the viewpoints described in this specification. Instead, the full scope corresponding to the content of the claims as language is provided, including all legal equivalents. Nevertheless, there can be no claims that are intended to include gists that do not meet the requirements of the applicable patent law, and the claims should not be construed in this way.

Claims

1. 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 drive device coupled to a proximal end portion of the needle; a plunger assembly at least partially provided within the housing, the plunger assembly including a plunger and a plunger drive device coupled to a proximal end portion of the plunger, the plunger being at least partially provided within the lumen of the needle, the plunger being configured to advance a shunt into the lumen of the needle; An inserter having an actuating mechanism rotatable to vary at least one of a length of the needle drive device or a length of the plunger drive device so that a clinician can adapt the inserter to a predetermined surgical procedure.

2. The inserter according to claim 1, wherein the plunger drive device moves in a direction opposite to that of the needle drive device when the actuating mechanism moves.

3. The inserter according to claim 1 or 2, wherein the plunger drive device extends and the needle drive device retracts when the actuating mechanism moves.

4. The inserter according to any one of claims 1 to 3, wherein the actuating mechanism includes an oval cam, and the oval cam is rotatable within the body of the needle drive device about an axis directed perpendicular to the longitudinal axis of the inserter.

5. The inserter according to any one of claims 1 to 4, wherein the actuating mechanism includes an oval cam, and the oval cam is rotatable within the body of the plunger drive device about an axis directed perpendicular to the longitudinal axis of the inserter.

6. The inserter according to any one of claims 1 to 5, wherein the actuating mechanism includes an oval cam having a major axis and a minor axis, and the lengths of the needle drive device and the plunger drive device are changed by rotating the oval cam to align the major axis with the longitudinal axis of the inserter.

7. The inserter according to any one of claims 1 to 6, further comprising a removable key, the removable key releasably engaging the actuating member to move the actuating member.

8. An intraocular shunt inserter for treating glaucoma, comprising: having a needle, said needle comprising a lumen and a proximal end portion of said needle, having a plunger assembly including a plunger at least partially disposed within the lumen of the needle, said plunger being configured to advance within the lumen of the needle upon release of the shunt, having a component drive device including an actuating member, said component drive device being an inserter that extends from a first length to a second length upon movement of the actuating member to change the longitudinal relative position of a distal end portion of the plunger when coupled to a proximal end portion of the plunger, or (ii) a distal end portion of the needle when coupled to a proximal end portion of the needle. **Claim 9** The inserter according to claim 8, wherein the actuating member includes an oval cam, and the oval cam is rotatable within the body of the component drive device about an axis oriented perpendicular to the longitudinal axis of the inserter. **Claim 10** The inserter according to claim 9, wherein the oval cam has a major axis and a minor axis, and the component drive device 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. **Claim 11** The inserter according to any one of claims 8-10, further having a removable key, said removable key releasably engaging the actuating member to move the actuating member. **Claim 12** The inserter according to claim 11, wherein the removable key is releasably engagable with the actuating member. **Claim 13** The inserter according to any one of claims 8-12, further having a housing, wherein the needle or the plunger is longitudinally movable from a first position to a second position relative to a distal portion of the housing. **Claim 14** A method of operating an intraocular shunt inserter, said method comprising: partially disposing a plunger within a lumen of a needle; and moving an actuating member of a plunger drive device to change the plunger drive device from a first plunger drive device length to a second plunger drive device length, said plunger drive device being coupled to a proximal end portion of the plunger. **Claim 15** The method according to claim 14, further comprising moving a distal end portion of the plunger from a first plunger position to a second plunger position with respect to the lumen before discharging the shunt into the lumen of the needle.

16. The method according to claim 14 or 15, further comprising moving a needle drive device actuating 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 a proximal end portion of the plunger.

17. The method according to claim 16, further comprising moving a distal end portion of the needle from a first needle position to a second needle position with respect to a distal end portion of the plunger before discharging the shunt into the lumen of the needle.

18. The method according to claim 16 or 17, further comprising simultaneously moving the plunger drive device actuating member and the needle drive device actuating member.

19. The method according to any one of claims 16 to 18, further comprising moving the plunger drive device in a direction opposite to that of the needle drive device during movement of the plunger drive device actuating member and the needle drive device actuating member.

20. The method according to any one of claims 16 to 19, further comprising releasably engaging the plunger drive device actuating member and the needle drive device actuating member with a removable key.

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