WO2025179131A1

WO2025179131A1 - Systems and methods for delivering adjustable shunting systems

Info

Publication number: WO2025179131A1
Application number: PCT/US2025/016775
Authority: WO
Inventors: Steven Pham; Abigail BRAZIL
Original assignee: Shifamed Holdings LLC
Current assignee: Shifamed Holdings LLC
Priority date: 2024-02-23
Filing date: 2025-02-21
Publication date: 2025-08-28
Anticipated expiration: 2026-08-23

Abstract

The present technology is generally directed to shunt delivery systems and associated methods for delivering and deploying adjustable shunts. The shunt delivery systems of the present technology can include an incision alignment feature configured to facilitate positioning an adjustable shunt through an incision, including through an incision formed in a patient's eye. The incision alignment feature can define a distalmost portion of the shunt delivery system and/or can be configured to be deployed distally beyond the adjustable shunt.

Description

SYSTEMS AND METHODS FOR

DELIVERING ADJUSTABLE SHUNTING SYSTEMS

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] The present application claims priority to U.S. Provisional Patent App. No. 63/557,023, filed February 23, 2024; and U.S. Provisional Patent App. No. 63/690,061, filed September 3, 2024; the entireties of which are both hereby incorporated by reference herein.

TECHNICAL FIELD

[0002] The present technology generally relates to systems and methods for delivering implantable medical devices and, in particular, to delivery systems and associated methods for delivering intraocular shunts.

BACKGROUND

[0003] Implantable shunting systems are widely used to treat a variety of patient conditions by shunting fluid from a first body region/cavity to a second body region/cavity. For example, shunting systems have been proposed for treating glaucoma. The flow of fluid through the shunting systems is primarily controlled by the pressure gradient across the shunt and the physical characteristics of the flow path defined through the shunt (e.g., the resistance of the shunt lumen). Conventional, early shunting systems (sometimes referred to as minimally invasive glaucoma surgery devices or “MIGS” devices) have shown clinical benefit; however, there is a need for improved shunting systems, systems for delivering such shunting systems, and techniques for addressing elevated intraocular pressure and risks associated with glaucoma. For example, there is a need for shunting systems capable of adjusting the therapy provided, including the flow rate between the two fluidly connected bodies. Further, there is a need for delivery systems for effectively and precisely delivering such shunting systems to target treatment locations within patients.

BRIEF DESCRIPTION OF THE DRAWINGS

[0004] Many aspects of the present technology can be better understood with reference to the following drawings. The components in the drawings are not necessarily drawn to scale. Instead, emphasis is placed on illustrating clearly the principles of the present technology. Furthermore, components can be shown as transparent in certain views for clarity of illustration only and not to indicate that the component is necessarily transparent. Components may also be shown schematically.

[0005] FIGS. 1A-1G illustrate a delivery system configured to deliver an adjustable shunting system in accordance with embodiments of the present technology.

[0006] FIG. 2 is a perspective view of another intraocular shunt delivery system configured in accordance with embodiments of the present technology.

[0007] FIGS. 3A-3F illustrate another delivery system configured to deliver an adjustable shunting system in accordance with embodiments of the present technology.

[0008] FIGS. 4A-4D illustrate another delivery system configured to deliver an adjustable shunting system in accordance with embodiments of the present technology.

[0009] FIG. 5A is a perspective view of a delivery system kit configured in accordance with embodiments of the present technology.

[0010] FIGS. 5B is a perspective view of a loading device of the delivery system kit of FIG. 5A.

[0011] FIGS. 5C and 5D are side cross-sectional views of a delivery system of the delivery system kit of FIG. 5A in first and second configurations, respectively.

[0012] FIGS. 5E is a perspective view of a distal end of the delivery system in the first configuration shown in FIG. 5C.

[0013] FIG. 5F is a perspective view of the distal end of the delivery system in the second configuration shown in FIG. 5D.

[0014] FIG. 6 is a flow diagram of a method for delivering an adjustable shunt using a delivery system configured in accordance with embodiments of the present technology.

[0015] FIGS. 7A-7F are perspective views of a delivery system during different stages of the process or method of FIG. 6 in accordance with embodiments of the present technology.

[0016] FIGS. 8A and 8B illustrate various stages of a procedure for deploying a shunt, such as an adjustable shunting system, into a patient’s eye using one or more of the systems described previously herein, in accordance with embodiments of the present technology.

[0017] FIG. 9A is a perspective view of another intraocular shunt delivery system configured in accordance with embodiments of the present technology. [0018] FIG. 9B is side cross-sectional view of the intraocular shunt delivery system of

FIG. 9A.

[0019] FIG. 10A is a perspective view of another intraocular shunt delivery system configured in accordance with embodiments of the present technology.

[0020] FIG. 10B is side cross-sectional view of the intraocular shunt delivery system of FIG. 10 A.

[0021] FIG. 11A is a perspective view of another intraocular shunt delivery system configured in accordance with embodiments of the present technology.

[0022] FIG. 1 IB is side cross-sectional view of the intraocular shunt delivery system of FIG. HA.

DETAILED DESCRIPTION

[0023] The present technology is generally directed to delivery systems and associated methods for delivering and/or deploying adjustable shunting systems. A delivery system configured in accordance with embodiments of the present technology can include a housing, a shuttle assembly positioned within the housing, and an actuator operably coupled to the shuttle assembly. In some embodiments, the shuttle assembly includes a push rod configured to carry or otherwise receive an adjustable shunting system. By moving the actuator relative to the housing, a user can move one or more portions of the shuttle assembly relative to the housing to advance the push rod and the adjustable shunting system distally from within the delivery system and, e.g., at least partially into an eye of the patient.

[0024] In at least some embodiments, the delivery systems of the present technology include an injection tip having a spur or other incision alignment feature that defines a distal- most portion of the delivery system. The user can insert this incision alignment feature into an incision formed in the patient’s eye to help align the adjustable shunting system with the incision and make it easier to insert the adjustable shunting system through the incision and at least partially into the patient’s eye.

[0025] The terminology used in the description presented below is intended to be interpreted in its broadest reasonable manner, even though it is being used in conjunction with a detailed description of certain specific embodiments of the present technology. Certain terms may even be emphasized below; however, any terminology intended to be interpreted in any restricted manner will be overtly and specifically defined as such in this Detailed Description section. Additionally, the present technology can include other embodiments that are within the scope of the claims but are not described in detail with respect to FIGS. 1A-1 IB.

[0026] Reference throughout this specification to “one embodiment” or “an embodiment” means that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment of the present technology. Thus, the appearances of the phrases “in one embodiment” or “in an embodiment” in various places throughout this specification are not necessarily all referring to the same embodiment. Furthermore, the particular features or characteristics may be combined in any suitable manner in one or more embodiments.

[0027] As used herein, the use of relative terminology, such as “about”, “approximately”, “substantially” and the like refer to the stated value plus or minus ten percent. For example, the use of the term “about 100” refers to a range of from 90 to 110, inclusive. In instances in which the context requires otherwise and/or relative terminology is used in reference to something that does not include a numerical value, the terms are given their ordinary meaning to one skilled in the art.

[0028] Reference throughout this specification to the term “resistance” refers to fluid resistance unless the context clearly dictates otherwise. The terms “drainage rate” and “flow rate” are used interchangeably to describe the movement of fluid through a structure at a particular volumetric rate. The term “flow” is used herein to refer to the motion of fluid, in general.

[0029] Although certain embodiments herein are described in terms of shunting fluid from an anterior chamber of an eye, one of skill in the art will appreciate that the present technology can be readily adapted to shunt fluid from and/or between other portions of the eye (including the posterior chamber), or, more generally, from and/or between a first body region and a second body region. Moreover, while the certain embodiments herein are described in the context of glaucoma treatment, any of the embodiments herein, including those referred to as “glaucoma shunts” or “glaucoma devices” may nevertheless be used and/or modified to treat other diseases or conditions, including other diseases or conditions of the eye or other body regions. For example, the systems described herein can be used to treat diseases characterized by increased pressure and/or fluid build-up, including but not limited to heart failure (e.g., heart failure with preserved ejection fraction, heart failure with reduced ejection fraction, etc.), pulmonary failure, renal failure, hydrocephalus, and the like. Moreover, while generally described in terms of shunting aqueous, the systems described herein may be applied equally to shunting other fluid, such as blood or cerebrospinal fluid, between the first body region and the second body region.

[0030] FIGS. 1A and IB are perspective and partially-exploded perspective views, respectively, of a delivery system 100 (“system 100”) configured for delivering an adjustable shunting system or shunt in accordance with select embodiments of the present technology. Referring to FIGS. 1A and IB together, the system 100 includes a housing 102 (shown as transparent in FIG. 1A for illustrative clarity), a shunt carriage or shuttle assembly 104, an actuator 106, a linkage or drive shaft 108, and an insertion tip 110. As best seen in FIG. IB, the housing 102 can include multiple housing portions (individually identified in FIG. IB as a first housing portion 102a and a second housing portion 102b) and/or the drive shaft 108 can include multiple portions (individually identified in FIG. IB as a first drive shaft portion 108a and a second drive shaft portion 108b). Using multiple portions to form the housing 102 and/or the drive shaft 108 can make it easier to manufacture these components and/or to assemble the overall system 100.

[0031] Referring again to FIGS. 1A and IB together, the actuator 106 can be movably coupled to the housing 102, such as on an exterior surface of the housing 102. The actuator 106 can be operably coupled to the drive shaft 108, e.g., via a slot 112 extending through at least a portion of the housing 102. The drive shaft 108 can, in turn, operably couple the actuator 106 to the shuttle assembly 104 so that the actuator 106 can be used to slidably move at least a portion of the shuttle assembly 104, e.g., relative to the housing 102. In the illustrated embodiment, the drive shaft 108 is positioned within the housing 102 at least partially between (e.g., radially between) the shuttle assembly 104 and the housing 102. In other embodiments, the drive shaft 108 can have one or more other suitable positions, such as on the exterior of the housing 102. The shuttle assembly 104 can be positioned at least partially within the housing 102 and can be configured to carry an adjustable shunt 101. The insertion tip 110 can be coupled to the housing 102, e.g., at a distal end thereof. As described further below, to operate the system 100, a user can move the actuator 106 linearly (e.g., in a distal direction toward the insertion tip 110) relative to the housing 102 to thereby rotate the drive shaft 108 and cause a corresponding linear (e.g., distally-directed) movement of the shuttle assembly 104 which, in turn, can advance the shunt 101 carried by the shuttle assembly 104 distally outwardly from within the insertion tip 110, e.g., to facilitate positioning the shunt 101 within a patient’s eye. [0032] FIG. 1C is an exploded view of the shuttle assembly 104. The shuttle assembly 104 can include first or shunt gripping component 114 and a second or shunt advancing component 1 16. The shunt gripping component 114 can include one or more gripping members 118 (individually identified in FIG. 1C as a first gripping member 118a and a second gripping member 118b) and define a slot or opening 120 configured to receive at least a portion of the shunt advancing component 116. The gripping members 118 can each include one or more elongate shims and/or other structures configured to apply pressure to or otherwise releasably secure the shunt 101 to the shuttle assembly 104. In some embodiments, one or more of the gripping members 118 includes a curved portion 130 configured to facilitate the gripping of the shunt 101. The shunt advancing component 116 can include a push rod 122 that defines an area or seat region 124 sized, shaped, and/or otherwise configured to receive the shunt 101. Both the shunt gripping component 114 and the shunt advancing component 116 can include one or more posts or pegs 126 (individually identified in FIG. 1C as a first post 126a of the shunt gripping component 114 and a second post 126b of the shunt advancing component 116) configured to operably couple the shunt gripping component 114 and the shunt advancing component 116 to the drive shaft 108 (FIGS. 1 A and IB).

[0033] FIG. ID is a side perspective view of the insertion tip 110, the gripping members 118, and the push rod 122. The gripping members 1 18 and the push rod 122 can be positioned within the insertion tip 110. The curved portion 130, included in the second gripping member 118b in the illustrated embodiment, can be driven against an inner surface of the insertion tip 110 to cause at least a portion of the second gripping member 118b located distally from the curved portion 130 to bend or deflect (e.g., upwardly, inwardly, etc.) and press against or otherwise engage the shunt 101. As best seen in FIG. ID, a distal portion 132 of the first gripping member 118a can extend distally beyond the shunt 101 and/or the insertion tip 110. The distal portion 132 can define a distal-most terminus of the system 100. In some embodiments, a clinician or other user can use the distal portion 132 to help align the shunt 101 with an incision in a patient’s eye. For example, during a procedure, the user can insert the distal portion 132 at least partially into an incision formed in a patient’s eye to at least partially align the shunt 101 with the incision and/or insert or otherwise facilitate the insertion of at least a portion of the shunt 101 through the incision.

[0034] FIG. IE is a side view of the shuttle assembly 104 and the drive shaft 108. The drive shaft 108 can include or define one or more drive slots 128 (individually identified in FIG. IE as a first drive slot 128a and a second drive slot 128b). Each of the drive slots 128 can be configured to receive a corresponding one of the posts 126 of the shuttle assembly 104, such that the drive slots 128 can direct the movement of the shuttle assembly 104 as the drive shaft 108 rotates about its longitudinal axis X. In the illustrated embodiment, for example, the first post 126a is slidably disposed within the first drive slot 128a and the second post 126b is slidably disposed within the second drive slot 128b.

[0035] The first drive slot 128a can include a primary first slot segment 128ai and a secondary first slot segment 128a2. The primary first slot segment 128ai can, relative to a longitudinal axis X of the drive shaft 108, extend radially (e.g., only radially) through the drive shaft 108, e.g., without or substantially without extending longitudinally in the proximal and/or distal directions. The secondary first slot segment 128a can, relative to the longitudinal axis X, extend radially and longitudinally (e.g., helically) through the drive shaft 108. For example, as shown in FIG. IE, the secondary first slot segment 128a2 can extend longitudinally in the proximal direction from the primary first slot segment 128ai .

[0036] The second drive slot 128b can include a primary second slot segment 128bi and a secondary second slot segment 128b2. The primary second slot segment 128bi can, relative to the longitudinal axis X, extend radially and longitudinally (e.g., in a distal direction) through the drive shaft 108. For example, as shown in FIG. IE, the primary slot segment 128b i can extend distally toward the first drive slot 128a. The secondary second slot segment 128b2 can, relative to the longitudinal axis X, extend radially through the drive shaft 108, e.g., without or substantially without extending longitudinally in the proximal and/or distal directions.

[0037] As described above, the drive shaft 108 can, as it is rotated, move at least a portion of the shuttle assembly 104 (e.g., the shunt gripping component 114 or the shunt advancing component 116) linearly relative to the drive shaft 108. For example, during a first portion of the rotation of the drive shaft 108, one of the shunt gripping component 114 and the shunt advancing component 116 can move relative to the drive shaft 108 while the other can remain stationary and, during a second portion of this rotation, the other of the shunt gripping component 114 and the shunt advancing component 116 can move relative to the drive shaft 108 while the other can remain stationary. In the illustrated embodiment, for example, as the drive shaft 108 rotates in a direction R, the primary first slot segment 128ai of the first drive slot 128a moves relative to the first post 126a and the primary second slot segment 128bi of the second drive slot 128b moves relative to the second post 126b. Because the primary first slot segment 128ai of the first drive slot 128a extends radially (e.g., only radially) about the longitudinal axis X, rotating the primary first slot segment 128ai does not translate the first post 126a and the associated shunt gripping component 114 along the longitudinal axis X or otherwise move the shunt gripping component 114 relative to the drive shaft 108. However, because the primary second slot segment 128bi of the second drive slot 128b extends radially and longitudinally (e.g., in a distal direction) about the longitudinal axis X, rotating the primary second slot segment 128bi translates the second post 126b and the associated shunt advancing component 116 along the longitudinal axis X relative to the drive shaft 108 and the shunt gripping component 114 in, e.g., the distal direction. The longitudinal aspect (e.g., the length relative to the longitudinal axis X) of the primary second slot segment 128b i can correspond to (e.g., equal) the total distance traveled by the shunt advancing component 116. Moving the shunt advancing component 116 distally relative to the shunt gripping component 114 in this manner can, for example, advance the shunt 101 (FIG. 1C) distally between the gripping members 118 (FIG. 1C) while the gripping members 118 grip or otherwise engage (e.g., continue to grip or otherwise engage) the shunt 101. As the drive shaft 108 continues to rotate in the direction R, the secondary first slot segment 128az of the first drive slot 128a moves relative to the first post 126a and the secondary second slot segment 128bi of the second drive slot 128b mores relative to the second post 126b. Because the secondary first slot segment 128a2 of the first drive slot 128a extends radially and longitudinally (e.g., in the proximal direction) about the longitudinal axis X, rotating the secondary first slot segment 128az translates the first post 126a and the associated shunt gripping component 114 along the longitudinal axis X relative to the drive shaft 108 and the shunt advancing component 116 in, e.g., the proximal direction. The longitudinal aspect (e.g., the length relative to the longitudinal axis X) of the secondary first slot segment 128a2 can correspond to (e.g., equal) the total distance traveled by the shunt gripping component 114. Moving the shunt gripping component 114 proximally relative to the shunt advancing component 116 in this manner can, for example, retract the gripping members 118 (FIG. 1C) proximally over the shunt 101 (FIG. 1C) to release or otherwise disengage the shunt 101 to allow the shunt 101 to be implanted within the patient. Because the secondary second slot segment 1281)2 of the second drive slot 128b extends radially (e.g., only radially) about the longitudinal axis X, rotating the secondary second slot segment 128b2 does not translate the second post 126b and the associated shunt advancing component 116 along the longitudinal axis X and/or otherwise move the shunt advancing component 116 relative to the drive shaft 108. This can, for example, facilitate retracting the gripping member 118 (FIG. 1C) over the shunt 101 to release the shunt 101, as described above. [0038] FIG. IF is a perspective view of the shuttle assembly 104, the actuator 106, and the drive shaft 108. The drive shaft 108 can further define a driven slot 134 and the actuator 106 can be operably coupled to the drive shaft 108 via the driven slot 134. In the illustrated embodiment, for example, the actuator 106 includes a post or shaft 136 and at least a portion of the post 136 is positioned within the driven slot 134. The driven slot 134 can, relative to the longitudinal axis X, extend radially and longitudinally (e.g., helically) through the drive shaft 108, e.g., in the distal direction. Accordingly, moving the actuator 106 in the distal direction can cause the drive shaft 108 to rotate in the direction R which, in turn, can move the shuttle assembly 104 as described previously with reference to at least FIG. IE. Operably linking these movements of the shuttle assembly 104 to a single actuator (e.g., the actuator 106) is expected to make the system 100 easier and/or more intuitive to operate and, in at least some embodiments, may allow the system 100 to be operated with a single hand.

[0039] FIG. 1G is a top plan view of the shunt 101 positioned within the area 124 of the push rod 122. The shunt 101 can include a body 103 having a first or proximal end portion 105a and a second or distal end portion 105b, and one or more wings or extended portions 111 (individually identified as first and second wings I l la, 111b) that extend outwardly from one or more other portions of the body 103. In some embodiments, one or more of the wings 111 can define coupling features (e.g., suture holes) configured to allow the shunt 101 to be secured in place, e.g., after implantation. The body 103 can be configured to contain a cartridge 107 which can contain one or more actuators (e.g., shape memory actuators) configured to be actuated to selectively control a resistance to fluid flow through the shunt 101. The body 103 can define one or more fluid channels 109 in fluid communication with the cartridge 107 such that fluid that flows through the cartridge 107 can flow out of the shunt 101 via one or more of the channels 109.

[0040] The area 124 can be configured to contact the shunt at one or more locations along the body 103. For example, although the shunt 101 is illustrated as spaced apart from the push rod 122 for illustrative clarity in FIG. 1 G, one or more of the wings 111 , the proximal end portion 105, and/or one or more surface portions between the wings 111 and the proximal end portion 105 can contact, be seated against, and/or otherwise be received by the area 124 so that advancing the push rod 122 distally (as described previously with reference to at least FIGS. 1D-1F) presses the push rod 122 against these features and/or associated surfaces of the shunt 101. Because the body 103 of the shunt 101 can be generally flexible, pressing against the shunt 101 in this manner can cause the body 103 to fold or compress, e.g., without or substantially without advancing the shunt distally. To reduce or prevent this folding, one or more of the gripping members 118 (FIGS. 1C and ID) can press against, grip, or otherwise engage a first or proximal portion 113a of the cartridge 107. The cartridge 107 can be less flexible (e.g., more rigid, have a higher modulus of elasticity, etc.) than the body 103, and the proximal portion 113a of the cartridge 107 can be more resistant to compressive forces than, e.g., a second or distal portion 113b of the cartridge 107 (which can contain actuation elements, gating elements, fluid openings, and other features that allow the cartridge 107 to be actuated to selectively control the resistance to fluid flow through the shunt 101).

[0041] FIG. 2 is a perspective view of another intraocular shunt delivery system 200 (“system 200”) configured in accordance with embodiments of the present technology. The system 200 can include one or more features that are at least generally similar or identical in structure and/or function to the system 100 (FIGS. 1A-1F). For example, the system 200 can include a housing 202 that is at least generally similar or identical in structure and/or function to the housing 102 (FIG. 1 A) and an insertion tip 210 that is at least generally similar or identical in structure and/or function to the insertion tip 110 (FIG. 1 A). However, the insertion tip 210 is curved relative to the housing 202. In some embodiments, the curved insertion tip 210 can improve the handling of the system 200 and/or make it easier for a physician to place an adjustable shunt at a desired location within a patient.

[0042] FIGS. 3A and 3B are perspective and partially-exploded perspective views, respectively, of a delivery system 300 (“system 300”) configured for delivering an adjustable shunting system or shunt in accordance with select embodiments of the present technology. The system 300 can include features that are at least generally similar or identical in structure and/or function to one or more features of one or more of the delivery systems described previously herein. For example, the system 300 can include a housing 302 (shown as transparent in FIG. 3 A for illustrative clarity) including an insertion tip portion 310, a shuttle assembly 304 including a drive shaft 308, and a slider or other actuator 306.

[0043] Referring to FIGS. 3 A and 3B together, the shuttle assembly 304 can be positioned at least partially within the housing 302 and configured to carry an adjustable shunt. The actuator 306 can be movably coupled to the housing 302 and operably coupled to the drive shaft 308 via, e.g., a slot 312 extending through a portion of the housing 302. The drive shaft 308 can be configured to operably couple the actuator 306 to other portions the shuttle assembly 304. Accordingly, as the shuttle assembly 304 moves relative to the housing 302, an adjustable shunt carried by the shuttle assembly 304 can be advanced distally outwardly from within the insertion tip portion 310 to facilitate positioning the shunt within a patient’s eye.

[0044] Referring to FIG. 3B, the housing 302 can include multiple housing portions (individually identified as a first housing portion 302a and a second housing portion 302b). Using multiple portions to form the housing 302 can make it easier to manufacture these components and/or to assemble the overall system 300.

[0045] The drive shaft 308 can include an elongate body that defines a slot 328 and a coupling tab or clutch 338. In addition to the drive shaft 308, the shuttle assembly 304 can include a gripping component 314 and a push rod 322. The push rod 322 can include an elongate body that defines an area or seat 324 sized, shaped, and/or otherwise configured to receive an adjustable shunt (e.g., the shunt 101 of FIG. 1 A), a first or drive opening 340 configured to receive a portion of the actuator 306, and a second or mating opening 342 configured to operably engage the clutch 338. The gripping component 314 can be configured to receive the adjustable shunt and/or a proximal portion of the push rod 322 including, e.g., the area 324 configured to receive the adjustable shunt. The drive shaft 308 can contact the gripping component 314 to, e.g., drive the gripping component 314 distally relative to the housing.

[0046] FIG. 3C is a side cross-sectional view of a portion of the system 300. The drive shaft 308 can define a channel 344 extending at least partially therethrough and that is configured to slidably receive the push rod 322. The actuator 306 can extend through the drive opening 340 in the push rod 322 and move proximally and/or distally relative to the housing 302. The drive opening 340 can be sized and/or otherwise configured to limit or prevent the actuator 306 from moving relative to the push rod 322 so that, e.g., any movement of the actuator 306 causes a corresponding movement of the push rod 322. The slot 328 through the drive shaft 308 can generally allow the actuator 306 to move distally relative to the drive shaft 308, for example, without also moving the drive shaft 308 distally. However, based on the position of the drive shaft 308 within the housing 302, the clutch 338 (e.g., a spur portion 348 of the clutch 338) may be releasably engaged with the mating opening 342 in the push rod 322 so that, e.g., any distal movement of the push rod 322 (due to, e.g., distal movement of the actuator 306) causes a corresponding distal movement of the drive shaft 308. For example, moving the actuator 306 proximally from the position shown in the illustrated embodiment will move both the drive shaft 308 and the push rod 322 proximally. As the drive shaft 308 moves proximally, the clutch 338 can contact a surface 346 of the housing 302 and this contact can drive the clutch 338, or at least the spur portion 348 thereof, into and/or through the mating opening 342. When at least a portion of the clutch 338 is positioned within/extending through the mating opening 342, the clutch 338 can movably couple the push rod 322 to the drive shaft 308 so that, e.g., moving the actuator 306 distally moves both the push rod 322 and the drive shaft 308 distally (e.g., over a same distance or by a same amount). The housing 302 can hold the clutch 338 in engagement with the push rod 322 until the clutch 338 is advanced distally beyond the surface 346 (e.g., when the drive shaft 308 is in the position shown in the illustrated embodiment), at which point the clutch 338 can return to the position shown in the illustrated embodiment and uncouple or release the push rod 322 from the drive shaft 308. After the clutch 338 releases the push rod 322, the actuator 306 can advance the push rod 322 distally relative to the drive shaft 308 and/or the housing 302 while, e.g., the drive shaft 308 remains in position/stationary relative to the housing 302.

[0047] FIGS. 3D and 3E are side perspective views of the gripping component 314 and the tip portion 310 of the housing 302. FIGS. 3D and 3E also illustrate the shunt 101 being carried by the gripping component 314 and the push rod 322. The position of the gripping component 314 in FIG. 3D can correspond to the position of the drive shaft 308 (FIG. 3C) in the embodiment illustrated in FIG. 3C. The position of the gripping component 314 relative to the housing 302 in FIG. 3E can correspond to a position of the drive shaft 308 in which the drive shaft 308 (FIG. 3C) has been moved proximally from the position shown in FIG. 3C such that the clutch 338 (FIG. 3C) is engaging the push rod 322.

[0048] The gripping component 314 can include one or more gripping members 318 (individually identified as first and second gripping members 318a, 318b), a distal or spur portion 332, and a ridge portion 350. The gripping members 318 can be spaced apart from one another such that the shunt 101 can be positioned between the gripping members 318, such as between the first and second gripping members 318a, 318b as shown in the illustrated embodiments. The gripping members 318 can be at least generally flexible and/or otherwise configured to undergo at least generally elastic deformation. In at least some embodiments, for example, the gripping members 318 can, in response to an external force, be configured to deform inwardly toward one another and/or the shunt 101 to grip or otherwise releasably engage the shunt 101 therebetween.

[0049] The spur portion 332 can define a distal-most terminus of the system 300. In the illustrated embodiment, the spur portion 332 extends distally from the first gripping member 318a. In these and/or other embodiments, the spur portion 332 can extend distally from the second gripping member 318b. Generally, the spur portion 332 can overhang (e.g., extend distally beyond) the shunt 101 and, accordingly, the spur portion 332 can define an incision alignment and/or engagement feature that a clinician or other user can use to help align the shunt 101 with an incision in a patient’s eye. For example, as described previously with reference to FIG. ID, during an implantation procedure, the user can insert the spur portion 332 at least partially into the incision to help align the shunt 101 with the incision.

[0050] The ridge portion 350 can extend outwardly from one or more other portions of the gripping members 318 and be configured to engage the tip portion 310 of the housing 302. In at least some embodiments, for example, the gripping component 14 can be moved proximally, e.g., from the position shown in FIG. 3D toward and/or to the position shown in FIG. 3E, to position the ridge portion 350 at least partially within the tip portion 310 of the housing 302. In this position, the ridge portion 350 can at least partially resist, or prevent entirely, distal movement of the gripping component 314 relative to the housing 302 unless or until a distally directed force sufficient to overcome this resistance is applied to the gripping component 314. A proximal surface of the ridge portion 350 can be ramped or sloped such that, as the gripping component 314 is moved proximally toward and/or into the tip portion 310, the ridge portion can drive one or more of the gripping members 318 toward one another to apply a compressive force to the shunt 101 that grips or otherwise retains the shunt 101 between the gripping members 318.

[0051] During an implantation procedure, to load the system 300, a user can position the shunt 101 between the gripping members 318 while the ridge portion 350 of the gripping component 314 is positioned external to the housing 302. Once the shunt 101 is seated between the gripping members 318, the user can move the gripping component 314 proximally until, e.g., the ridge portion 350 is positioned within the tip portion 310 and/or the gripping members 318 apply a compressive force to the shunt 101. Then, to implant the shunt 101, the user can move the actuator 306 (FIG. 3C) distally with sufficient force to overcome any resistance created by the ridge portion 350 and advance the gripping component 314 distally. As described previously with reference to FIG. 3C, moving the actuator 306 proximally can move both the push rod 322 and the drive shaft 308 (FIG. 3C) until, e.g., the clutch 338 (FIG. 3C) is moved out of engagement with the push rod 322. Because the drive shaft 308 can contact and drive the movement of the gripping component 314, once the clutch 338 is moved out of engagement with the push rod 322 further distal movement of the actuator 306 can move the push rod 322 relative to the drive shaft and/or the gripping component 314. This can, for example, advance the shunt 101 out from between the gripping members 318, through and incision, and/or into a patient’s eye. At various times during the implantation process, the user can position the spur portion 332 at least partially within an incision in the patient’s eye, or otherwise align the spur portion 332 with the incision, to help facilitate implanting the shunt 101.

[0052] FIG. 3F is a perspective view of the shunt 101 positioned within the area 324 of the push rod 322. As described previously with reference to FIG. 1G, the push rod 322 can be configured to contact one or more portions of the shunt 101, such as the wings 111 and/or the proximal end portion 105a (shown using blue arrows in FIG. 3F). Additionally, the gripping members 318 (FIG. 3D and 3E) can be configured to press against the proximal portion 113a of the cartridge 107. The spur portion 332 of the gripping component 314 (FIGS. 3D and 3E) is illustrated schematically for reference.

[0053] FIG. 4A is a perspective view of another delivery system 400 configured for delivery of an adjustable shunting system in accordance with embodiments of the present technology. The system 400 can include at least some features that are at least generally similar or identical in structure and/or function to one or more features of one or more of the delivery systems described previously herein. For example, the system 400 can include a housing 402 (illustrated as transparent in FIG. 4A for illustrative clarity) including an insertion tip portion 410, an actuator 406, and/or a shuttle assembly 404 including a drive shaft 408, a gripping component 414, and a push rod 422. However, compared to the system 300 illustrated in FIGS. 3 A-3E, which comprises a slidable actuator 306, the actuator 406 of the system 400 can include one or more wheels or rotatable members. In the illustrated, for example, the actuator 406 includes a first or drive wheel 452 and a second or driven wheel 454. The drive wheel 452 can be rotatably coupled to the driven wheel 454 such that a user can rotate drive wheel 452 to cause the driven wheel 454 to rotate. The driven wheel 454 can, in turn, be operably coupled to the shuttle assembly 404 (e.g., the drive shaft 408 and the push rod 422) so that rotation of the driven wheel 454 can cause corresponding movement (e.g., linear movement) of the shuttle assembly 404.

[0054] FIG. 4B is a front view of the system 400, illustrating section line 4C-4C and section line 4D-4D, used for cross-sectional views in FIGS. 4C and 4D, respectively. As shown, section line 4C-4C extends along a midplane of the system 400 and through the drive wheel 452 and section line 4D-4D is offset from but parallel to section line 4C-4C (and, e.g., the midplane). Section line 4D-4D is also offset from the drive wheel 452. [0055] FIG. 4C is a side cross-sectional view of a portion of the system 400 taken substantially along section line 4C-4C in FIG. 4B. The drive shaft 408 can define a slot 428. The push rod 422 can define one or more drive openings 440 (individually identified in FIG. 4C as first through fourth drive openings 440a-d). The driven wheel 454 can include one or more gear teeth 456 (only one labeled in FIG. 4C for illustrative clarity). Each of the gear teeth 456 can be configured to extend through the slot 428 in the drive shaft 408 and be received within a corresponding one of the drive openings 440 (e.g., the labeled gear tooth 456 extends through the first drive opening 440a).

[0056] During an implantation procedure, a user can rotate the drive wheel 452 in a first direction R1 to thereby cause the driven wheel 454 to rotate in a second direction R2 (e.g., opposite the first direction Rl). As the driven wheel 454 rotates, individual ones of the gear teeth 456 can engage, sequentially and/or in succession, corresponding ones of the drive openings 440a-d to move the push rod 422 distally. The user can rotate the drive wheel 452 in the second direction R2 to produce the opposite effect, that is, the user can rotate the drive wheel 452 in the second direction R2 to rotate the driven wheel 454 in the first direction Rl and move the push rod 422 proximally.

[0057] FIG. 4D is a side-cross-sectional view of a portion of the system 400 taken substantially along section line 4D-4D in FIG. 4B. The driven wheel 454 can further include a radially extended portion 458 that extends circumferentially around a portion of an axis of rotation of the driven wheel 454. The slot 428 in the drive shaft 408 can further include a widened or medial portion 460 configured to receive the radially extended portion 458 of the driven wheel 454. As the driven wheel 454 rotates, as described with reference to FIG. 4C, the radially extended portion 458 can move through the medial portion 460 of the slot 428 to contact and move the drive shaft 408 proximally and/or distally. Continued rotation of the driven wheel 454 can rotate the radially extended portion 458 out of contact with the medial portion 460 of the slot 428. When the radially extended portion 458 no longer contacts the medial portion 460 of the slot 428, further rotation of the driven wheel 454 can move the push rod 422 but not the drive shaft 408 unless or until the radially extended portion 458 is rotated back into contact with the medial portion 460.

[0058] During an implantation procedure, with the drive shaft 408 and the push rod 422 in the positions shown in FIG. 4C and 4D, the user can rotate the drive wheel 452 in the first direction Rl to cause the driven wheel 454 to rotate in the second direction R2, as described previously with reference to FIG. 4C. As the driven wheel 454 rotates in the second direction R2, the gear teeth 456 (FIG. 4C) can engage the drive openings 440a-d (FIG. 4C) to move the push rod 422 distally while the radially extended portion 458 of the driven wheel 454 engages the medial portion 460 of the slot 428 to also move the drive shaft 408 distally. As the drive shaft 408 moves distally, the drive shaft 408 can contact the gripping component 414 (FIG. 4A) and drive the gripping component 414 distally. As the user continues rotating the drive wheel 452 in the first direction Rl, the radially extended portion 458 of the driven wheel 454 will rotate out of contact with the medial portion 460 of the slot 428. At or after this point, the user can continue rotating the drive wheel 452 in the first direction Rl to move the push rod 422 further distally without, or substantially without, moving the drive shaft 408 distally. That is, once the user has rotated the radially extended portion 458 of the driven wheel 454 out of contact with the medial portion 460 of the slot 428, further rotation of the driven wheel 454 will advance the push rod 422 distally relative to the drive shaft 408. This can, for example, drive the shunt 101 (FIG. 4 A) distally outward from within the gripping component 414 and/or at least partially through an incision in a patient’s eye.

[0059] FIG. 5 A is a perspective view of a delivery system kit 599 (“kit 599”) configured in accordance with embodiments of the present technology. The kit 599 can include a delivery system 500 (“system 500”) configured for delivering an adjustable shunting system or shunt and a loading device 590. As described in further detail below, including with reference to FIGS. 5B and 7A-7F, the loading device 590 can be configured to facilitate loading an adjustable shunt (e.g., the shunt 101 of FIG. 1G) and/or one or more other shunts into a delivery system, such as the delivery system 500.

[0060] FIGS. 5B is a perspective view of the loading device 590. The loading device 590 can include a body 592 having a first surface 594 that at least partially defines a loading channel 596 and one or more second surfaces 591 (individually identified in FIG. 5B as primary second surface 591a and secondary second surface 591b) that at least partially define an alignment feature 593. The loading channel 596 can include one or more contact portions or support features 598 (individually identified in FIG. 5B as a first support feature 598a, a second support feature 598b, and a third support feature 598c), each of which can be configured to receive a corresponding portion of the adjustable shunt 101 to support the adjustable shunt 101 at a distance D (e.g., up to 1 mm, 2 mm, 3 mm, 4 mm, 5 mm, 10 mm, and/or combinations thereof) above the first surface 594. In at least some embodiment, for example, the first support feature 598a is configured to receive the distal end portion 105b (FIG. 1G) of the adjustable shunt 101, the second support feature 598b is configured to receive one of the wings 1 l la-b (FIG. 1G) of the adjustable shunt 101, and the third support feature 598c is configured to receive the other of the wings 11 la-b. In these and/or other embodiments, one or more of the support features 598 can be configured to contact additional and/or other portions of the adjustable shunt 101, the loading channel 596 can include more contact portions configured to contact these and/or other portions of the adjustable shunt 101, and/or the loading channel 596 can include a lesser number of contact portions 776.

[0061] The alignment feature 593 can include a shelf or notch defined at least partially by the intersection between the first and second surfaces 594, 591. In the illustrated embodiment, for example, the first surface 594 is a horizontal (or at least generally horizontal) surface and the second surfaces 591 are vertical (or at least generally vertical) surfaces that are each positioned on opposing (e.g., left and right) sides of the loading channel 596 and extend perpendicularly and/or upwardly from the first surface 594.

[0062] When an adjustable shunt is positioned within the loading channel 596, the alignment feature 593 can be configured to assist a user in positioning a distal portion of a delivery system into the loading channel 596 to engage the adjustable shunt. For example, as described further below, including with reference to FIGS. 7A-7E, the user can position the distal portion of the delivery system against one of the second surfaces 591 (e.g., the secondary second surface 591b) and move the distal portion in a first direction (e.g., laterally, such as right-to-left) along the second surface 591, e.g., until the distal portion is aligned with the loading channel 596, at which point the user can move the distal portion in a second direction (e.g., distally) into the loading channel 596. The second direction can be different than (e.g., at least generally perpendicular to) the first direction. With the distal portion positioned in the loading channel 596, the user can actuate the delivery system to engage the adjustable shunt supported in the loading channel 596. Because the support features 598 are configured to support the adjustable shunt at the distance D from the first surface 594, using the alignment feature 593 to move the distal portion of the delivery system into alignment with the loading channel 596 is expected to reduce the likelihood that the user inadvertently bends, deforms, or damages the adjustable shunt while loading it into the delivery system.

[0063] FIGS. 5C and 5D are side cross-sectional views of the delivery system 500 in a first or pre-actuated configuration and a second or actuated configuration, respectively, in accordance with embodiments of the present technology. At least some aspects of the delivery system 500 can be at least generally similar or identical in structure and/or function to one or more aspects of one or more of the other delivery systems described herein. For example, the delivery system 500 includes a housing 502 and one or more gripping members 518 (individually identified in FIGS. 5C and 5D as first gripping member 518a and second gripping member 518b) positioned at least partially within the housing 502. In some embodiments, the gripping members 518 are a pair of forceps.

[0064] The gripping members 518 can he secured to the housing 502 to at least partially prevent the gripping members 518 from moving longitudinally relative to the housing 502. In the illustrated embodiment, for example, a proximal portion of the gripping members 518 can be received within an end cap 584 coupled to the housing 502 and can define an opening 515 configured to receive a bolt 517 or other fastener therethrough. The bolt 517 can extend through a portion of the housing 502 and can be coupled to a nut 519 or other corresponding fastener to secure the gripping members 518 and the end cap 584 to the housing 502 to at least partially prevent the gripping members 518 from moving longitudinally relative to the housing 502.

[0065] The delivery system 500 can further include an actuator 506 and a drive shaft 508. The actuator 506 can be operably coupled to one or more of the gripping members 518 and a drive shaft 508. In the illustrated embodiment, for example, the first gripping member 518 defines a slot 521 configured to receive a barrel nut or other fastener 523 therethrough which can be coupled to the actuator 506 via a bolt or other corresponding fastener 525 that extends at least partially through the actuator 506. The slot 521 can allow the actuator 506 to move (e.g., longitudinally) relative to the gripping member 518. Additionally, because the actuator 506 is coupled to the first gripping member 518a, the user can actuate (e.g., press) the actuator 506 to move the first gripping member 518a towards the second gripping member 518b. For example, to transition the system 500 from the first configuration (FIG. 5C) toward the second configuration (FIG. 5D), the user can first actuator the actuator 506 to move the first gripping member 518a towards the second gripping member 518b and move the actuator 506 distally along and/or relative to the first gripping member 518a. In some embodiments, the actuator 506 includes a locking feature 531 at a distal end thereof, and moving the actuator 506 distally along and/or relative to the first gripping member 518a can position at least a portion of the locking feature portion 531 between the housing 502 and the first gripping member 518a, e.g., to hold the first gripping member 518a in a clasped or shunt-gripping configuration (such as shown in FIG. 5D) and/or otherwise at least partially prevent the first gripping member 518a from moving away from the second gripping member 518b. The ability to “lock” or otherwise maintain the gripping members 518a, 518b in the shunt-gripping configuration is expected to improve the ease of use of the system 500, e.g., by allowing the user to focus on advancing the shunt through an incision without also having to concentrate on maintaining the gripping members 518a, 518b in the shunt-gripping configuration.

[0066] The drive shaft 508 can be configured to selectively allow the actuator 506 to be moved relative to the first gripping members 518a. For example, the drive shaft 508 can be configured to be received through respective openings 527 (individually identified as first opening 527a and second opening 527b) in the gripping members 518a-b and to engage a first drive surface 529a and/or a second drive surface 529b within the actuator 506. The openings 527 can be configured to hold the drive shaft 508 in place (e.g., longitudinally in place) relative to the gripping members 518 and/or the actuator 506. The first drive surface 529a can include a wall or other feature configured to at least partially prevent the actuator 506 from moving (e.g., distally) relative to the drive shaft 508. The second drive surface 529b can include a longitudinal (e.g., horizontal, sloped, etc.) surface or other feature configured to allow the actuator 506 to move (e.g., distally) relative to the drive shaft 508. The second drive surface 529b can be positioned above (e.g., superior to) and/or can extend (e.g., proximally) from the first drive surface 529a. When transitioning the system 500 from the first configuration (FIG. 5C) toward the second configuration (FIG. 5D), the drive shaft 508 can abut or contact the first drive surface 529a to at least partially prevent the user from moving the actuator (e.g., distally) relative to the first gripping member 518a. Accordingly, the user can first actuate (e.g., press) the actuator 506 to move the first gripping member 518a and the actuator 506 toward the second gripping member 518b while also moving the first drive surface 529a out of contact with the drive shaft 508. Once the drive shaft 508 has cleared the first drive surface 529a and, e.g., is in contact with the second drive surface, the drive shaft 508 can allow the user to move the actuator 506 (e.g., distally) relative to the first gripping member 518a. Accordingly, transitioning the system 500 from the first configuration (FIG. 5C) toward the second configuration (FIG. 5D) can include moving the first gripping member 518a toward the second gripping member 518b and then moving the actuator 506 relative to the first gripping member 518a to position at least a portion of the locking feature portion 531 between the housing 502 and the first gripping member 518a as described above.

[0067] In some embodiments, the system 500 further includes an incision alignment and/or engagement feature 580 (“incision alignment feature 580”) configured to assist a user in aligning the system 500 with an incision. The incision alignment feature 580 can be coupled to the actuator 506 (e.g., within receiving channel 533), can be movable therewith, and can extend distally from the actuator 506 along the first gripping member 518a. Referring additionally to FIGS. 5E and 5F, which are perspective views of a distal end of the first gripping member 518a with the delivery system 500 in the first and second configurations, respectively, the system 500 can include a bracket 582 coupled to the first gripping member 518a and the bracket 582 can define a tunnel 583 configured to receive at least a portion of the incision alignment feature 580 and/or secure the incision alignment feature 580 against the first gripping member 518. In some embodiments, the incision alignment feature 580 has a first width (e.g., measured perpendicular to a longitudinal axis of the system 500), the first gripper member has a second width (e.g., measured perpendicular to a longitudinal axis of the system 500), and the first width is less than (e.g., at least 1%, 5%, 10%, 20%, 30%, 40%, 50%, 60%, 70%, 80%, 90%, 95%, and/or combinations thereof less than) the second width.

[0068] The incision alignment feature 580 can be deploy able from within the tunnel 583 in response to movement of the actuator 506. For example, because the incision alignment feature 580 can be coupled to the actuator 506, the incision alignment feature 580 can move in response to movement of the actuator 506. When the user advances the actuator 506 distally relative to the first gripping member 518a, that movement of the actuator 506 can also move the incision alignment feature 580 distally relative to the first gripping member 518a so that a distal portion 532 (FIG. 5D) of the incision alignment feature 580 extends (e.g., is “deployed”)_distally beyond the first gripping member 518a. The distal portion 532 of the incision alignment feature 580 can be configured to be positioned at least partially within an incision, e.g., an incision in a patient’s eye, to align the system 500 and/or an adjustable shunt carried thereby with the incision and/or otherwise facilitate positioning the adjustable shunt at least partially through the incision. Because the incision alignment feature 580 can move with the actuator 506, the incision alignment feature 580 can be “locked” or otherwise maintained in the distally-extended or deployed configuration unless or until the user moves the actuator 506 so as to disengage the locking feature 531 from the housing 502, at which point the distal portion 532 of the incision alignment feature 580 can be retracted (e.g., automatically) toward and/or into the tunnel 583.

[0069] As best seen in FIG. 5F, in some embodiments the incision alignment feature 580 includes a curved, looped, and/or U-shaped wire. In at least some embodiments, for example, the wire can extend between first and second end portions (which, e.g., can include respective first and second ends of the wire), and both the first and second end portions can be coupled to the actuator 506 (FIGS. 5C and 5D) and/or one or more other portions of the system 500. In the illustrated embodiment, for example, the wire includes a first segment, a second segment parallel to the first segment, and a curved tip segment between the first segment and the second segment. In a retracted configuration (e.g., FIG. 5E), the curved tip segment can be positioned proximal to the distal ends of the first gripper member 518a and the second gripper member 518b (FIG. 5C). In a deployed configuration (e.g., FIG. 5F), the curved tip segment, a portion of the first segment, and a portion of the second segment can be positioned distal to the distal ends of the first gripper member 518a and the second gripper member 518b (FIG. 5D). The wire can be composed of nitinol, stainless steel, platinum, a polymer, one or more other suitable materials, and/or combinations thereof. The incision alignment feature 980 can define an interior area or opening 986 that is free of material and configured to decrease an overall surface area of the incision alignment feature 980. This reduction in surface area is expected to decrease friction forces on the incision alignment feature 980 when, e.g., a user inserts the incision alignment feature 980 through an incision and/or into a patient’s eye.

[0070] FIG. 6 is a flow diagram of a process or method 600 for delivering an adjustable shunt using a delivery system configured in accordance with embodiments of the present technology. Although features of the method 600 are described in the context of the system 500 and the loading device 590 shown in FIG. 5A for illustration, one skilled in the art will readily understand that the method 600 can be carried out using other suitable systems and/or devices described herein. FIGS. 7A-7F are perspective views of the system 500 and the loading device 590 of FIG. 5A during different stages of the method 600, in accordance with embodiments of the present technology. Individual ones of FIGS. 7A-7F are described below with reference to one or more blocks 602-608 of the method 600.

[0071] At block 602, the method 600 can include positioning an adjustable shunt in a loading device. Positioning the adjustable shunt in the loading device can include positioning the adjustable shunt at least partially within a loading channel of the loading device and/or seating the adjustable shunt against one or more contact features located within the loading channel. For example, as shown in FIG. 7A, the shunt 101 can be positioned in the loading channel 596 of the loading device 590. As described previously herein, including with reference to FIG. 5B, the shunt 101 can be supported in the loading channel 596 by the one or more support features 598 and at a distance D (FIG. 5B) from the first surface 594 of the loading device 590.

[0072] At block 604, the method 600 can include engaging the adjustable shunt with a delivery system. Engaging the adjustable shunt with the delivery system can include moving the delivery system in a first direction relative to the adjustable shunt and/or the loading device, such as along an alignment feature of the loading device and/or toward the loading channel, and then moving the delivery system in a second direction relative to the adjustable shunt and/or the loading device, such as into the loading channel and/or longitudinally relative to the adjustable shunt. For example, as shown in FIG. 7B, the second gripping member 518b of the system 500 can be positioned against (or at least proximate to) one of the second surfaces 591 (e.g., the secondary second surface 591) and spaced laterally apart from the loading channel 596 and/or the adjustable shunt 101. The user can then move the second gripping member 518b along the alignment feature 593 in a first direction, toward and/or into alignment with and/or at least partway into the loading channel 596, as shown in FIG. 7C. At least a proximal portion of the adjustable shunt 101 can extend outwardly from/beyond the loading channel 596 and, accordingly, moving the system 500 in the first direction can position at least this proximal portion of the adjustable shunt 101 between the first and second gripping members 518a-b. From the position shown in FIG. 5C, the user can move the gripping members 518 in a second direction into (e.g., further into) the loading channel 596, until the distal ends of the gripping members 518 are at least proximate to the cartridge 107 within the adjustable shunt 101, as shown in FIG. 7D, at which point the user can actuate the actuator 506 (FIGS. 5C and 5D) to engage the adjustable shunt 101 (and/or the cartridge 107 thereof) between the gripping members 518. Moving the gripping members 518 in the second direction can include moving the gripping members 518 distally away from the one or more second surfaces 591 and/or in a direction at least generally perpendicular to the first direction. The distance D between the adjustable shunt and the first surface 594 can create room for the second gripping member 518b to pass between the adjustable shunt 101 and the first surface 594 and thereby allow the first and second gripping members 518a-b to engage the adjustable shunt 101. In some embodiments, the user can use a holder tool 787 (FIGS. 7B and 7C) to hold the adjustable shunt 101 within the loading channel 596 while engaging the adjustable shunt 101 with the system 500.

[0073] At block 606, the method 600 can include removing the adjustable shunt from the loading device using the delivery system. For example, as shown in FIG. 7E, after engaging the adjustable shunt 101 between the gripping members 518 the user can lift the adjustable shunt 101 out from the loading channel 596, e.g., by raising the system 500 or otherwise moving it away from the loading device 590.

[0074] At block 608, the method 600 can include deploying an incision alignment feature of the delivery system to extend distally beyond the adjustable shunt. For example, as shown in FIG. 7F, the user can move the actuator 506 (FIGS. 5C and 5D) distally relative to the first gripping members 518a to deploy the incision alignment feature 580 to overhang or otherwise extend distally beyond a distal-most end of the adjustable shunt 101. Block 608 is optional and can be omitted in at least some embodiments, such as embodiments involving a delivery system with a non-deployable incision alignment feature (e.g., the delivery system 100 of FIG. 1).

[0075] In some embodiments, the method 600 can further include positioning at least a portion of the incision alignment feature 580 within an incision, such as an incision in an eye of a patient, and implanting the adjustable shunt 101 with at least a portion (e.g., a distal portion) of the adjustable shunt 101 positioning through the incision, as described elsewhere herein including with reference to FIGS. 8 A and 8B. Implanting the adjustable shunt 101 can include (i) while the incision alignment feature 580 is positioned within the incision, advancing the adjustable shunt 100 using the delivery system until at least a portion of the adjustable shunt 100 extends through the incision; (ii) retracting the incision alignment feature 580 (e.g., from a deployed configuration toward and/or to a retracted configuration) relative to one or more other portions of the delivery system while retaining at least the portion of the adjustable shunt 100 within the incision; and/or (iii) while the incision alignment feature 580 is in the retracted configuration, further advancing the adjustable shunt 100 through the incision until the adjustable shunt 100 is in fluid communication with an anterior chamber of the eye. Further advancing the adjustable shunt 100 through the incision can include using the system 500 to grasp a second or more proximally located portion of the adjustable shunt 100 after a first or more distally located portion of the adjustable shunt 100 has been positioned at least partially within and/or advanced through the incision, including as described elsewhere herein.

[0076] In some embodiments, the incision alignment feature 580 can be positioned above and/or anterior to the adjustable shunt 100 (e.g., with respect to the patient and/or the patient’s eye) when the incision alignment feature 580 is deployed and/or positioned within the incision. Stated differently, in at least some embodiments, after the incision alignment feature 580 has positioned within the incision, at least a portion of the shunt can be positioned below and/or posterior to the incision alignment feature 580 with respect to the patient and/or the patient’s eye (e.g., in the orientation shown in FIG. 7F). Advancing the adjustable shunt 100 through the incision with the incision alignment feature 580 above/anterior to the adjustable shunt 100 is expected to at least partially prevent the adjustable shunt 100 from bending or flexing upwardly /in an anterior direction during insertion. [0077] FIGS. 8A and 8B illustrate various stages of a procedure for deploying the shunt 101 into a patient’s eye E using one or more of the systems described herein, in accordance with embodiments of the present technology. In a particular example, the shunt 101 can be deployed such that, after implantation, the adjustable shunt 101 is positioned to route fluid from an anterior chamber of the patient’s eye E to a suitable outflow location, such as a subconjunctival bleb space (e.g., to treat glaucoma).

[0078] Referring first to FIG. 8 A, one or more tools 862 (e.g., a keratome) can be used to make one or more incisions 864 in the eye E. One or more of the systems 100, 200, 300, 400, 500 can be actuated to deploy the shunt 101 through the incision 864 and at least partially into the eye E. Referring next to FIG. 8B, the adjustable shunt 101 can be positioned in the eye E such that the distal portion 105b of the adjustable shunt 101 is positioned in a first body region 870a (e.g., within the eye E),the proximal portion 105a of the adjustable shunt 101 is positioned in a second body region 870b (e.g., exterior to the eye E), and a central portion or region of the adjustable shunt 101 between the distal portion 105h and the proximal portion 105a is positioned at least partially within the incision formed through the eye 101. Accordingly, after implantation, fluid within the first body region 870a can flow/drain through the adjustable shunt 101 toward and/or into the second body region 870b. In some embodiments, the adjustable shunt 101 can be configured to assume a curved, bent, or preformed shape during/after implantation in the patient, as shown in FIG. 8B. To facilitate positioning the adjustable shunt 101 through the incision, the user can first position a distal portion and/or other incision alignment feature of a delivery system (e.g., the distal portion 132 of FIG. ID, the spur portion 332 of FIGS. 3D and 3E, the incision alignment feature 580 of FIGS. 5D, 5F, and 7F) at least partially within and/or through the incision 864. Using an incision alignment feature to facilitate positioning a shunt through an incision is expected to reduce the resistance associated with advancing the shunt through the incision, which in turn can allow the shunt to be positioned with less force and/or a reduced likelihood of damage and/or deformation.

[0079] Although in FIG. 8B the distal portion 105b of the adjustable shunt 101 is illustrated as being positioned anterior to (e.g., in front of/above) the patient’s iris I, in other embodiments the distal portion 150b can be positioned posterior to (e.g., behind/below) the iris I (also referred to as “sub- iris” positioning). The sub-iris positioning of the adjustable shunt 101 is expected to reduce or prevent corneal endothelial disease and/or failure, for example, by reducing or preventing disruption to nutrient and/or other fluid and/or chemical transport to and/or through the corneal endothelium. Additionally, or alternatively, at least a portion of the adjustable shunt 101 (e.g., the proximal portion 105a) can be positioned (e.g., tucked) under and/or posterior to a conjunctiva of the patient’s eye. In the illustrated embodiment, the adjustable shunt 101 is configured to receive fluid (e.g., aqueous) through one or more openings or inlets in an upper or anteriorly-facing surface 874a of the adjustable shunt 101. In these and other embodiments, including when the adjustable shunt 101 has a sub-iris position, the adjustable shunt 101 can be configured to receive fluid through one or more lateral openings, e.g., positioned in one or more sides 876a, 876b of the adjustable shunt 101 , and/or through one or more openings in a bottom or posteriorly-facing surface 874b of the adjustable shunt 101.

[0080] In general, the adjustable shunt 101 can be configured to actuate and/or change its resistance to fluid flow in response to energy (e.g., laser energy) delivered from a source external to the patient. An example of such a configuration is described in detail in U.S. Patent No. 1 1 ,291 ,585, and incorporated herein by reference for all purposes. In embodiments in which the adjustable shunt 101 is positioned sub-iris, the adjustable shunt 101 can be actuated using a number of techniques. For example, a portion of the iris I can be removed (e.g., iridectomy) to provide line-of-sight access to the adjustable shunt 101. Additionally, or alternatively, the adjustable shunt 101 can be positioned such that at least a portion of the adjustable shunt 101 (e.g., at least part of the distal portion 105b) can be exposed when the eye E undergoes pupil dilation. In such embodiments, the pupil of the eye E can be dilated and then energy can be delivered to actuate the adjustable shunt 101. In these and other embodiments, the energy can be targeted using a first energy source (e.g., a first laser) configured to transmit first energy (e.g., targeting energy) at or near a first wavelength to which the iris I is translucent or transparent, and then a same or different energy source can transmit second energy (e.g., actuating energy) at a second wavelength different than the first wavelength.

[0081] In some embodiments, the adjustable shunt 101 can be configured to reduce or prevent cellular growth onto, over, and/or around at least a portion of the adjustable shunt 101. In at least some embodiments, for example, all or a portion of the adjustable shunt 101 can include one or more radioisotopes configured to inhibit or prevent cellular growth. The radioisotopes can include Phosporous-32, Strontium- 89, Strontium-90, Yttrium-90, and/or another suitable radioisotope. Individual ones of the radioisotopes can emit alpha, beta, and/or gamma radiation, each of which are expected to inhibit or prevent cellular growth on, over, and/or near the adjustable shunt 101. For a given patient, the radioisotope(s) used with the adjustable shunt 101 can be selected based at least partially on the half-life of the radioisotope, the type of radiation, and/or the energy of the emitted alpha, beta, and/or gamma particles. The radioisotopes can be naturally-occurring or manufactured (e.g., using a cyclotron, reactor- produced, etc.).

[0082] FIG. 9A is a perspective view of another intraocular shunt delivery system 900 (“system 900”) configured in accordance with embodiments of the present technology. FIG. 6B is side cross-sectional view of the system 900. Referring to FIGS. 9A and 9B together, the system 900 can include one or more features that are at least generally similar to or identical in structure and/or function to one or more features of one or more of the delivery systems described previously herein. For example, the system 900 can include a housing 902 that is at least generally similar or identical in structure and/or function to the housing 502 (FIG. 5C), a slider or other actuator 906 that is at least generally similar or identical in structure and/or function to the actuator 506 (FIG. 5C), and one or more gripping members 918 (individually identified as first and second gripping members 918a, 918, respectively) that are at least generally similar or identical in structure and/or function to the gripping members 518 (FIG. 5C). The actuator 906 can be operably coupled to the one or more gripping members 918 and movable relative to the housing 902 to control a gripping state of the system 900. In at least some embodiments, for example, the actuator 906 can be advanced (e.g., proximally) to move the gripping members 918 toward one another so as to, e.g., grasp an adjustable shunting system positioned therebetween. In some embodiments, the gripping members 918 are a pair of forceps received at least partially within the housing 902. In some embodiments, the gripping members 918 can include teeth and/or other traction elements configured to reduce or prevent movement of the adjustable shunt 101 relative to the eye E during, e.g., at least a portion of a procedure to deploy the shunt into the eye E.

[0083] The system 900 can further include an incision alignment feature 980. The incision alignment feature 980 can include a spur 932 that defines a distal-most terminus of the system 900. In the illustrated embodiment, the spur 932 is coupled to and extends distally from the first gripping member 918a. In these and/or other embodiments, the spur 932 can be coupled and extend distally from the second gripping member 918b. Generally, the spur 932 can overhang (e.g., extend distally beyond) a shunt (e.g., shunt 101) carried between the gripping members 918 and, accordingly, a clinician or other user can use the spur 932 to help align the shunt with an incision in a patient’s eye, as described previously herein. In the illustrated embodiment, a bracket 982 or other coupling structure couples the incision alignment feature 980 to the first gripping member 918a. In these and/or other embodiments, the incision alignment feature 980 can be directly coupled to the first gripping member 918a and/or the second gripping member 918b via e.g., adhesive.

[0084] In some embodiments, the bracket 982 and/or one or more other portions of the system 900 can include a cleat and/or other coupling structure configured to receive one or more looping traction corneal sutures that prevent, or at least partially prevent, relative movement between the patient’s eye and the system 900. For example, the looping traction corneal suture can extend between and/or couple the system 900 to the eye. In some embodiments, the cleat and/or other coupling structure is configured to provide an adjustable amount of force (e.g., tensile force) to the suture. For example, the cleat and/or other coupling structure can be biased (via, e.g., one or more springs) to maintain a desired amount of tension on the suture and can be operably coupled to an actuator or other control configured to adjust the amount of tension applied to the suture. In these and/or other embodiments, the system 900 can be configured to manipulate one or more of the sutures to, e.g., adjust a position and/or orientation of the patient’ s eye.

[0085] In some embodiments, the system 900 includes an end cap 984 configured to receive at least a portion (e.g., a proximal portion) of one or more of the gripping members 918. The end cap 984 can be configured to maintain a position of the gripping members 918 relative to the housing. In some embodiments, the end cap 984 can be advanced (e.g., proximally) over the gripping members 918 to, e.g., hold the gripping members in a partially or fully-closed/gripped state.

[0086] FIG. 10 A is a perspective view of another intraocular shunt delivery system 1000 (“system 1000”) configured in accordance with embodiments of the present technology. FIG. 10B is side cross-sectional view of the system 1000. Referring to FIGS. 10A and 10B together, the system 1000 can be at least generally similar or identical in structure and/or function to the system 900 (FIGS. 9A and 9B). For example, the system 1000 includes an actuator 1006 that is at least generally similar or identical in structure and/or function to the actuator 906 (FIGS. 9A and 9B). However, whereas the system 900 had a housing 902 with generally flat sides, the system 1000 includes a housing 1002 with generally curved or rounded sides.

[0087] FIG. 11 A is a perspective view of another intraocular shunt delivery system 1100 (“system 1100”) configured in accordance with embodiments of the present technology. FIG. 11B is side cross-sectional view of the system 1100. Referring to FIGS. 11A and 11B together, the system 1100 can be at least generally similar or identical in structure and/or function to the system 900 (FIGS. 9A and 9B). For example, the system 1 100 includes a housing 1102 that is at least generally similar or identical in structure and/or function to the housing 902 (FIGS. 5C and 5D). However, whereas the system 900 has an actuator 906 that is generally rectangular, the system 1100 includes an actuator 1106 that is generally circular.

[0088] Any of the delivery systems described herein can be configured to grasp and/or regrasp an adjustable shunting system when, e.g., the adjustable shunting system is positioned at least partially within an eye of a patient. In at least some embodiments, for example, the delivery systems of the present technology can allow a user to (i) grasp or grip a first portion of an adjustable shunt, (ii) advance the adjustable shunt toward and/or at least partially through an incision, (iii) at least partially release the first portion of the adjustable shunt from the delivery system, (iv) regrip a second, different (e.g., more proximally located) portion of the adjustable shunt using the delivery device, and (v) after regripping the second, different portion of the adjustable shunt, further advance the adjustable shunt at least partially through the incision. Additionally, or alternatively, any of the delivery systems described herein can be operable through multiple grasping stages, such as a first or open stage (in which, e.g., no force is applied to the adjustable shunting system), a second or closed/clamped stage (in which, e.g., a maximum allowable force is applied to the adjustable shunting system), and a third or partially closed/clamped stage (in which, e.g., an intermediate magnitude of force less than the maximum allowable force but greater than zero is applied to the adjustable shunting system). In these and/or other embodiments, any of the delivery systems described herein can include markings and/or other indicia configured to facilitate grasping and/or grasping of the adjustable shunting system. For example, the markings can be configured to indicate, to a user, the proper distance, location, orientation, etc. at which to grasp to regrasp the adjustable shunting system.

Examples

[0089] Several aspects of the present technology are described with reference to the following examples:

1. A delivery system for delivering a shunt to an eye of a patient, the delivery system comprising: a first gripper member configured to engage a first side of the shunt; a second gripper member configured to engage a second side of the shunt, wherein the second side is opposite the first side; and an incision engagement feature configured to be positioned at least partially within an incision in the eye of the patient to facilitate the delivery of the shunt therethrough, wherein the incision engagement feature is operably associated with one of the first gripper member or the second gripper member and, in at least one configuration, extends distally beyond the other of the first gripper member or the second gripper member.

2. The delivery system of example 1 wherein the incision engagement feature includes a distalmost portion of the first gripper member or the second gripper member, and wherein the distalmost portion extends distally beyond the other of the first gripper member or the second gripper member.

3. The delivery system of example 1 or 2 wherein the incision engagement feature includes a wire loop coupled to the first gripper member or the second gripper member.

4. The delivery system of example 3 wherein the wire loop defines an interior area that is free of material.

5. The delivery system of any of examples 1-4 wherein the incision engagement feature includes a wire, wherein the wire extends between a first end portion and a second end portion, and wherein the first end portion and the second end portion are coupled to the first gripper member or the second gripper member.

6. The delivery system of any of examples 1-5 wherein the incision engagement feature includes a spur coupled to one of the first gripper member or the second gripper member, and wherein the spur extends distally beyond the other of the first gripper member or the second gripper member.

7. The delivery system of any of examples 1-5 wherein, when the first and second gripper members engage the shunt, the incision engagement feature is configured to extend distally beyond the shunt. 8. The delivery system of any of examples 1—7, further comprising: a housing configured to contain at least respective portions of the first gripper member and the second gripper member; and an actuator movably coupled to the housing and operably coupled to the first gripper member to change a spacing between the first gripper member and the second gripper member.

9. The delivery system of example 8, further comprising a bracket configured to be coupled to the first gripper member, wherein the bracket at least partially defines a channel configured to slidably receive the incision engagement feature.

10. The delivery system of example 8 or 9 wherein: the actuator includes a first drive surface and a second drive surface and is configured to move in a first direction toward the second gripper member and in a second direction distally relative to the first gripper member, the delivery system further comprises a drive shaft operably coupled to the first gripper member and/or the second gripper member, prior to moving the actuator in the first direction, the drive shaft is configured to contact the first drive surface to at least partially prevent the actuator from being moved in the second direction, and after moving the actuator in the first direction, the drive shaft is configured to contact the second drive surface and allow the actuator to be moved in the second direction.

11. The delivery system of example 10 wherein the first drive surface includes a vertical wall and wherein the second drive surface includes a horizontal or sloped surface extending proximally from the vertical wall.

12. The delivery system of example 10 or 1 1 wherein the incision engagement feature includes a wire coupled to the actuator, and wherein a distal portion of the wire extends distally beyond the first gripper member and the second gripper member after the actuator has been moved in the second direction. 13. The delivery system of example 12 wherein the distal portion of the wire includes a looped or U-shaped portion of the wire.

14. The delivery system of any of examples 10-13 wherein the actuator includes a locking feature configured to engage the housing after the actuator

15. The delivery system of example 1, further comprising: a shuttle assembly, wherein the shuttle assembly includes the first gripper member and the second gripper member; an actuator; and a drive shaft configured to operably couple the actuator to the shuttle assembly, wherein, in response to a linear movement of the actuator in a direction, the drive shaft is configured to rotate and thereby cause a corresponding linear movement of at least a portion of the shuttle assembly in the direction.

16. The delivery system of example 15 wherein the shuttle assembly includes: a shunt gripping component operably coupled to the drive shaft, wherein the shunt gripping component includes the first gripper member and the second gripper member; and a shunt advancing component operably coupled to the drive shaft, wherein the shunt advancing component includes a pushrod that defines a seat configured to receive at least a portion of the shunt and position the shunt at least partially between the first gripper member and the second gripper member.

17. The delivery system of example 15 or 16 wherein the shuttle assembly includes: a shunt gripping component operably coupled to the drive shaft, wherein the shunt gripping component includes the first gripper member and the second gripper member; and a shunt advancing component operably coupled to the drive shaft, wherein — during a first portion of the rotation of the drive shaft, the shunt gripping component is configured to move in the direction, and during a second portion of the rotation of the drive shaft, the shunt advancing component is configured to move in the direction.

18. The delivery system of any of examples 15-17 wherein the shuttle assembly includes: a shunt gripping component operably coupled to the drive shaft, wherein the shunt gripping component includes the first gripper member and the second gripper member; and a shunt advancing component operably coupled to the drive shaft, wherein — during a first portion of the rotation of the drive shaft, the shunt gripping component is configured to move relative to the shunt advancing component, and during a second portion of the rotation of the drive shaft, the shunt advancing component is configured to move relative to the shunt gripping component.

19. The delivery system of any of examples 15-18 wherein the shuttle assembly includes: a shunt gripping component operably coupled to the drive shaft, wherein the shunt gripping component includes the first gripper member and the second gripper member; and a shunt advancing component operably coupled to the drive shaft, wherein — during a first portion of the rotation of the drive shaft, the shunt advancing component does not move relative to the drive shaft, and during a second portion of the rotation of the drive shaft, the shunt gripping component does not move relative to the drive shaft.

20. The delivery system of example 19 wherein the drive shaft defines: a first drive slot configured to operably engage the shunt gripping component; and a second drive slot configured to operably engage the shunt advancing component. 21. The delivery system of example 20 wherein the shunt gripping component includes a first post configured to be slidably received within the first drive slot and wherein the shunt advancing component includes a second post configured to be slidably received within the second drive slot.

22. The delivery system of example 20 or 21 wherein the first drive slot includes: a primary first drive slot portion extending radially about at least a portion of a longitudinal axis of the drive shaft and configured to maintain a position of the shunt gripping component relative to the drive shaft during a first portion of the rotation of the drive shaft; and a secondary first drive slot portion extending radially about at least a portion of a longitudinal axis and longitudinally from the primary first drive slot portion and configured to move the shunt gripping component relative to the drive shaft during a second portion of the rotation of the drive shaft

23. The delivery system of any of examples 20-22 wherein the second drive slot includes: a primary second drive slot portion extending radially and longitudinally about at least a portion of a longitudinal axis of the drive shaft and configured to move the shunt advancing component relative to the drive shaft during a first portion of the rotation of the drive shaft; and a secondary second drive slot portion extending radially about at least a portion the longitudinal axis and configured to maintain a position of the shunt gripping component relative to the drive shaft during a second portion of the rotation of the drive shaft.

24. The delivery system of any of examples 15-24, further comprising: a housing configured to at least partially contain the shuttle assembly and the drive shaft; and an injector tip coupled to the housing, wherein the actuator is operable to displace the shunt from the injector tip and through the incision. 25. The delivery system of example 1, further comprising: a gripping component including the first gripper member and the second gripper member; a push rod positioned at least partially between the first gripper member and the second gripper member, wherein the push rod is configured to displace the shunt outwardly from between the first gripper member and the second gripper member; a drive shaft configured to contact the gripping component, wherein the drive shaft includes a clutch configured to selectively engage the push rod to movably couple the drive shaft thereto; and an actuator configured to operably engage the push rod, wherein proximally-directed movement of the actuator causes the clutch to engage the push rod to movably couple the drive shaft and the push rod, and wherein distally-directed movement of the actuator cause the clutch to disengage the push rod allow the push rod to move relative to the drive shaft.

26. The delivery system of example 25, further comprising a housing configured to at least partially contain the gripping component, the push rod, and the drive shaft, wherein: the housing defines an internal surface, the proximally-directed movement of the actuator bring the clutch into contact with the internal surface to thereby drive the clutch into engagement with the push rod, and the distally -directed movement of the actuator moves the clutch distally beyond the internal surface to allow the clutch to disengage the push rod.

27. The delivery system of example 25 or 26 wherein the clutch includes a spur portion and wherein the push rod defines an opening configured to receive the spur portion to movable couple the drive shaft to the push rod.

28. The delivery system of any of examples 25-27 wherein the push rod defines a drive opening, wherein the drive shaft defines a slot, and wherein the actuator is configured to pass through the slot to be received at least partially within and drivably engage the push rod via the drive opening. 29. The delivery system of example 28 wherein the slot is configured to allow the actuator to move relative to the drive shaft when the clutch disengages the push rod.

30. The delivery system of any of examples 25-29, further comprising a housing configured to at least partially contain the gripping component, the push rod, and the drive shaft, wherein the gripping component further includes a ridge portion configured to releasably engage the housing to at least partially prevent distal movement of the gripping component relative to the housing.

31. The delivery system of example 1 , further comprising: a gripping component including the first gripper member and the second gripper member; a push rod positioned at least partially between the first gripper member and the second gripper member, wherein the push rod is configured to displace the shunt outwardly from between the first gripper member and the second gripper member; a drive shaft configured to contact the gripping component; and a wheel including one or more gear teeth configured to operably engage the push rod and a radially extended portion configured to operably engage the drive shaft.

32. The delivery system of example 31 wherein the wheel has an axis of rotation, and wherein the radially extended portion extends partially around the axis of rotation.

33. The delivery system of example 31 or 32 wherein rotation of the wheel can move the radially extend portion (i) into contact with the drive shaft to cause a corresponding movement thereof and (ii) out of contact with the drive shaft to at least partially prevent movement thereof.

34. A delivery system kit for a shunt, the delivery system kit comprising: the delivery system of any one of claims 1-33; and a loading device configured to facilitate loading the shunt into the delivery system.

35. The delivery system kit of example 34, further comprising the shunt. 36. The delivery system kit of example 34 or 35 wherein the loading device includes: a loading channel with one or more support features configured to support the shunt at least partially within the loading channel; and an alignment channel configured to facilitate engaging the shunt with the delivery system when the shunt is positioned within the loading channel.

37. The delivery system kit of example 36 wherein the loading device further includes: a first surface; and a second surface that extends upwardly from the first surface and is positioned laterally from the loading channel, wherein the intersection between the first surface and the second surface at least partially defines the alignment channel.

38. The delivery system kit of example 36 or 37 wherein the loading device further includes: a first surface; and a second surface that extends upwardly from the first surface, wherein the loading channel extends distally from the first surface.

39. The delivery system kit of any of examples 36-38 wherein the loading device further includes a surface that at least partially defines the loading channel, wherein the one or more support features are configured to support the shunt a distance above the surface, and wherein the distance is configured to receive the second gripper member to allow the delivery system to engage the shunt when the shunt is positioned within the loading channel.

40. A method of implanting a shunt at least partially within an eye of a patient using a delivery system, the method comprising: engaging the shunt with the delivery system; positioning an incision alignment feature of the delivery system at least partially within an incision in the eye of the patient; and implanting the shunt with at least a portion of the shunt positioned through the incision. 41. The method of example 40, further comprising: positioning the shunt in a loading device; and removing the shunt from the loading device using the delivery system.

42. The method of example 40 or 41 wherein the shunt is positioned within a loading channel of a loading device, and wherein engaging the shunt with the delivery system includes: moving a gripping member of the delivery system in a first direction toward the loading channel through an alignment channel of the loading device; and moving the gripping member in a second direction into the loading channel.

43. The method of example 42 wherein moving the gripping member in the first direction includes moving the gripping member laterally toward the loading channel, and wherein moving the gripping member in the second direction includes advancing the gripping member distally into the loading channel.

44. The method of example 42 or 43 wherein moving the gripping member in the second direction includes moving the gripping member into a space between the loading device and the shunt.

45. The method of any of examples 42-44 wherein the second direction is perpendicular to the first direction.

46. The method of any of examples 40—45 wherein: the delivery system includes — a first gripper member, a second gripper member, and an actuator operably coupled to the first gripper member and the incision alignment feature; engaging the shunt with the delivery system includes moving the actuator and the first gripper member in a first direction toward the second gripper member to engage at least a portion of the shunt therebetween; and the method further comprises moving the actuator in a second direction and relative to the first gripper member to cause the incision alignment feature to extend distally beyond the first gripper member and the second gripper member.

47. A method of implanting an intraocular shunt within an eye of a patient using a delivery device having an incision engagement element and a body, the method comprising: holding the intraocular shunt in the delivery device, wherein a distal end of the intraocular shunt extends past a distal end of the body; advancing the incision engagement element relative to the body from (a) a retracted configuration in which the incision engagement element does not extend distally beyond the distal end of the body, to (b) a deployed configuration in which a portion of the incision engagement element extends past the distal end of the body and the distal end of the intraocular shunt; while the incision engagement element is in the deployed configuration, inserting the portion of the incision engagement element into an incision in the eye; while the incision engagement element is positioned within the incision, advancing the intraocular shunt using the delivery device until at least a portion of the intraocular shunt extends through the incision; retracting the incision engagement element relative to the body from the deployed configuration toward the retracted configuration while retaining the at least portion of the intraocular shunt within the incision; and while the incision engagement element is in the retracted configuration, further advancing the intraocular shunt through the incision until the intraocular shunt is in fluid communication with an anterior chamber of the eye.

48. The method of example 47 wherein the body includes a first gripper member configured to releasably engage a first side of the shunt and a second gripper member configured to releasably engage a second side of the shunt, and wherein respective distal ends of the first gripper member and the second gripper member define the distal end of the body.

49. The method of example 47 or 48 wherein advancing the intraocular shunt using the delivery device until at least a portion of the intraocular shunt extends through the incision comprises advancing the intraocular shunt with the incision engagement element in the deployed configuration.

50. The method of example 49 wherein a relative position between the intraocular shunt, the incision engagement element, and the body remains fixed while advancing the intraocular shunt until at least a portion of the intraocular shunt extends through the incision.

51. The method of any of examples 47-50 wherein further advancing the intraocular shunt through the incision until the intraocular shunt is in fluid communication with an anterior chamber of the eye comprises: at least partially releasing the intraocular shunt from the delivery device; regripping a different portion of the intraocular shunt using the delivery device; and after regripping the different portion of the intraocular shunt, further advancing the intraocular shunt.

52. The method of any of examples 47-51 wherein the intraocular shunt includes a first end portion, a second end portion, and a central region between the first end portion and the second end portion, and wherein further advancing the intraocular shunt until the intraocular shunt is in fluid communication with the anterior chamber comprises positioning the first end portion in fluid communication with the anterior chamber of the eye such that the central region sits within the incision and the second end portion remains external to the incision.

53. The method of example 52, further comprising using the delivery device to position the second end portion under a conjunctiva of the eye.

54. The method of example 53, wherein using the delivery device to position the second end portion under the conjunctiva comprises: at least partially releasing the intraocular shunt from the delivery device; regripping the second end portion using the delivery device; and using the delivery device to tuck the second end portion under the conjunctiva. 55. The method of any of examples 47-54, further comprising loading the intraocular shunt into the delivery device using a loading tool and with the incision engagement element in the retracted configuration.

56. The method of any of examples 47-55 wherein the incision engagement element comprises a wire loop.

57. The method of any of examples 47-56 wherein, while the incision engagement element is positioned within the incision, at least the portion of the incision engagement element is positioned anterior to the intraocular shunt.

58. A delivery device for implanting an intraocular shunt into an eye of a patient, the delivery device comprising: a first gripper member configured to releasably engage a first side of the shunt; a second gripper member configured to releasably engage a second side of the shunt, wherein the first gripper member and the second gripper member are at least partially moveable relative to each other to releasably grasp the shunt therebetween; a deployable incision engagement element sized and shaped to be inserted into an incision in the patient’s eye; and an actuator, wherein the actuator is actuatable to transition the incision engagement element between (a) a retracted configuration in which the incision engagement element does not extend distally beyond distal ends of the first gripper member and the second gripper member, and (b) a deployed configuration in which the incision engagement element extends distally beyond the distal ends of the first gripper member and the second gripper member.

59. The delivery device of example 58 wherein, in the deployed configuration, the incision engagement element is configured to extend past a distal end of the shunt earned between the first gripper member and the second gripper member. 60. The delivery device of example 58 or 59 wherein the incision engagement element is operably coupled to and deploy able from one of the first gripper member or the second gripper member.

61. The delivery device of any of examples 58-60 wherein the incision engagement element comprises a wire loop.

62. The delivery device of example 61 wherein the wire loop is composed of Nitinol.

63. The delivery device of example 61 or 62 wherein the wire loop includes a first segment, a second segment parallel to the first segment, and a curved tip segment between the first segment and the second segment, and wherein: in the retracted configuration, the curved tip segment is proximal to the distal ends of the first gripper member and the second gripper member, and in the deployed configuration, the curved tip segment, a portion of the first segment, and a portion of the second segment are distal to the distal ends of the first gripper member and the second gripper member.

64. The delivery device of any of examples 58-63 wherein the incision engagement element includes a first width and the first gripper element includes a second width, and wherein the first width is less than the second width.

65. The delivery device of example 64 wherein the first width is at least 50% less than the second width.

66. The delivery device of any of examples 58-65 wherein the actuator comprises a slidable member.

67. The delivery device of any of examples 58-66, further comprising a locking mechanism for selectively locking the incision engagement element in the retracted configuration or the deployed configuration. 68. The delivery device of any of examples 58-67 wherein the first side of the shunt is an anteriorly-facing side, and wherein, while in the deployed configuration, at least a portion of the incision engagement element is configured to be positioned anterior to the anteriorly- facing side of the shunt.

Conclusion

[0090] The above detailed description of embodiments of the technology are not intended to be exhaustive or to limit the technology to the precise form disclosed above. Although specific embodiments of, and examples for, the technology are described above for illustrative purposes, various equivalent modifications are possible within the scope of the technology as those skilled in the relevant art will recognize. For example, any of the features of the delivery systems for adjustable shunts described herein may be combined with any of the features of the other delivery systems described herein and vice versa. Moreover, although steps are presented in a given order, alternative embodiments may perform steps in a different order. The various embodiments described herein may also be combined to provide further embodiments.

[0091] From the foregoing, it will be appreciated that specific embodiments of the technology have been described herein for purposes of illustration, but well-known structures and functions associated with intraocular shunts have not been shown or described in detail to avoid unnecessarily obscuring the description of the embodiments of the technology. Where the context permits, singular or plural terms may also include the plural or singular term, respectively.

[0092] Unless the context clearly requires otherwise, throughout the description and the examples, the words “comprise,” “comprising,” and the like are to be construed in an inclusive sense, as opposed to an exclusive or exhaustive sense; that is to say, in the sense of “including, but not limited to.” As used herein, the terms “connected,” “coupled,” or any variant thereof, means any connection or coupling, either direct or indirect, between two or more elements; the coupling of connection between the elements can be physical, logical, or a combination thereof. Additionally, the words “herein,” “above,” “below,” and words of similar import, when used in this application, shall refer to this application as a whole and not to any particular portions of this application. Where the context permits, words in the above Detailed Description using the singular or plural number may also include the plural or singular number respectively. As used herein, the phrase “and/or” as in “A and/or B” refers to A alone, B alone, and A and B. Additionally, the term “comprising” is used throughout to mean including at least the recited feature(s) such that any greater number of the same feature and/or additional types of other features are not precluded. It will also be appreciated that specific embodiments have been described herein for purposes of illustration, but that various modifications may be made without deviating from the technology. Further, while advantages associated with some embodiments of the technology have been described in the context of those embodiments, other embodiments may also exhibit such advantages, and not all embodiments need necessarily exhibit such advantages to fall within the scope of the technology. Accordingly, the disclosure and associated technology can encompass other embodiments not expressly shown or described herein.

Claims

CLAIMS I/We claim:

1. A method of implanting an intraocular shunt within an eye of a patient using a delivery device having an incision engagement element and a body, the method comprising: holding the intraocular shunt in the delivery device, wherein a distal end of the intraocular shunt extends past a distal end of the body; advancing the incision engagement element relative to the body from (a) a retracted configuration in which the incision engagement element does not extend distally beyond the distal end of the body, to (b) a deployed configuration in which a portion of the incision engagement element extends past the distal end of the body and the distal end of the intraocular shunt; while the incision engagement element is in the deployed configuration, inserting the portion of the incision engagement element into an incision in the eye; while the incision engagement element is positioned within the incision, advancing the intraocular shunt using the delivery device until at least a portion of the intraocular shunt extends through the incision; retracting the incision engagement element relative to the body from the deployed configuration toward the retracted configuration while retaining the at least portion of the intraocular shunt within the incision; and while the incision engagement element is in the retracted configuration, further advancing the intraocular shunt through the incision until the intraocular shunt is in fluid communication with an anterior chamber of the eye.

2. The method of claim 1 wherein the body includes a first gripper member configured to releasably engage a first side of the shunt and a second gripper member configured to releasably engage a second side of the shunt, and wherein respective distal ends of the first gripper member and the second gripper member define the distal end of the body.

3. The method of claim 1 wherein advancing the intraocular shunt using the delivery device until at least a portion of the intraocular shunt extends through the incision comprises advancing the intraocular shunt with the incision engagement element in the deployed configuration.

4. The method of claim 3 wherein a relative position between the intraocular shunt, the incision engagement element, and the body remains fixed while advancing the intraocular shunt until at least a portion of the intraocular shunt extends through the incision.

5. The method of claim 1 wherein further advancing the intraocular shunt through the incision until the intraocular shunt is in fluid communication with an anterior chamber of the eye comprises: at least partially releasing the intraocular shunt from the delivery device; regripping a different portion of the intraocular shunt using the delivery device; and after regripping the different portion of the intraocular shunt, further advancing the intraocular shunt.

6. The method of claim 1 wherein the intraocular shunt includes a first end portion, a second end portion, and a central region between the first end portion and the second end portion, and wherein further advancing the intraocular shunt until the intraocular shunt is in fluid communication with the anterior chamber comprises positioning the first end portion in fluid communication with the anterior chamber of the eye such that the central region sits within the incision and the second end portion remains external to the incision.

7. The method of claim 6, further comprising using the delivery device to position the second end portion under a conjunctiva of the eye.

8. The method of claim 7, wherein using the delivery device to position the second end portion under the conjunctiva comprises: at least partially releasing the intraocular shunt from the delivery device; regripping the second end portion using the delivery device; and using the delivery device to tuck the second end portion under the conjunctiva.

9. The method of claim 1 , further comprising loading the intraocular shunt into the delivery device using a loading tool and with the incision engagement element in the retracted configuration.

10. The method of claim 1 wherein the incision engagement element comprises a wire loop.

11. The method of claim 1 wherein, while the incision engagement element is positioned within the incision, at least the portion of the incision engagement element is positioned anterior to the intraocular shunt.

12. A delivery device for implanting an intraocular shunt into an eye of a patient, the delivery device comprising: a first gripper member configured to releasably engage a first side of the shunt; a second gripper member configured to releasably engage a second side of the shunt, wherein the first gripper member and the second gripper member are at least partially moveable relative to each other to releasably grasp the shunt therebetween; a deployable incision engagement element sized and shaped to be inserted into an incision in the patient’s eye; and an actuator, wherein the actuator is actuatable to transition the incision engagement element between (a) a retracted configuration in which the incision engagement element does not extend distally beyond distal ends of the first gripper member and the second gripper member, and (b) a deployed configuration in which the incision engagement element extends distally beyond the distal ends of the first gripper member and the second gripper member.

13. The delivery device of claim 12 wherein, in the deployed configuration, the incision engagement element is configured to extend past a distal end of the shunt carried between the first gripper member and the second gripper member.

14. The delivery device of claim 12 wherein the incision engagement element is operably coupled to and deployable from one of the first gripper member or the second gripper member.

15. The delivery device of claim 12 wherein the incision engagement element comprises a wire loop.

16. The delivery device of claim 15 wherein the wire loop is composed of Nitinol.

17. The delivery device of claim 15 wherein the wire loop includes a first segment, a second segment parallel to the first segment, and a curved tip segment between the first segment and the second segment, and wherein: in the retracted configuration, the curved tip segment is proximal to the distal ends of the first gripper member and the second gripper member, and in the deployed configuration, the curved tip segment, a portion of the first segment, and a portion of the second segment are distal to the distal ends of the first gripper member and the second gripper member.

18. The delivery device of claim 12 wherein the incision engagement element includes a first width and the first gripper element includes a second width, and wherein the first width is less than the second width.

19. The delivery device of claim 18 wherein the first width is at least 50% less than the second width.

20. The delivery device of claim 12 wherein the actuator comprises a slidable member.

21. The delivery device of claim 12, further comprising a locking mechanism for selectively locking the incision engagement element in the retracted configuration or the deployed configuration.

22. The delivery device of claim 12 wherein the first side of the shunt is an anteriorly-facing side, and wherein, while in the deployed configuration, at least a portion of the incision engagement element is configured to be positioned anterior to the anteriorly-facing side of the shunt.