Ophthalmic implants, inserter devices, and methods for inserting ophthalmic implants.

Abstract

To provide an intraocular drainage device capable of increasing drainage of aqueous humor from the anterior chamber.SOLUTION: An intraocular drainage device (100) includes a tube (106) having a distal end, and a body (102) disposed proximally to the tube. An inlet port is disposed on the distal end of the tube and configured to receive an influent fluid from an anterior chamber of an eye. An inlet fluid pathway is coupled to the inlet port and extends at least partially through the tube. Multiple outlet fluid pathways extend at least partially through the body, and branch from the inlet fluid pathway. Multiple outlet ports are disposed on the body and coupled to the plurality of outlet fluid pathways.SELECTED DRAWING: Figure 1

Description

Background Art

[0001] Aqueous humor generally drains from the anterior chamber of the eye through conventional outflow pathways (trabecular meshwork and Schlemm's canal) and non-conventional outflow pathways (uveoscleral). However, depending on the situation, the drainage of aqueous humor may decrease, increasing intraocular pressure (IOP), which may damage the optic nerve. Therefore, it is desirable to be able to increase the drainage of aqueous humor from the anterior chamber, especially for glaucoma patients.

Summary of the Invention

Means for Solving the Problems

[0002] The accompanying drawings, which are incorporated herein and constitute a part of this specification, are included to provide a further understanding of the technology of the subject matter and serve to illustrate aspects of the technology of the subject matter and, in conjunction with the description, explain the principles of the technology of the subject matter.

Brief Description of the Drawings

[0003] [Figure 1] It is a schematic diagram showing an intraocular implant system according to some embodiments of the present disclosure. [Figure 2] It is a cross-sectional view showing an in-situ intraocular drainage device in a patient's eye according to some embodiments of the present disclosure. [Figure 3] It is a three-dimensional view showing an intraocular drainage device according to some embodiments of the present disclosure. [Figure 4] It is a top view showing an intraocular drainage device according to some embodiments of the present disclosure. [Figure 5] It is a top view showing an intraocular drainage device according to some embodiments of the present disclosure. [Figure 6] It is a three-dimensional view showing an intraocular drainage device according to some embodiments of the present disclosure. [Figure 7] It is a top view showing an intraocular drainage device according to some embodiments of the present disclosure. [Figure 8A]This figure shows a method for creating a two-part intraocular drainage device according to some embodiments of the present disclosure. [Figure 8B] This figure shows a method for creating a two-part intraocular drainage device according to some embodiments of the present disclosure. [Figure 9A] This figure shows a method for creating an intraocular drainage device according to some embodiments of the present disclosure. [Figure 9B] This figure shows a method for creating an intraocular drainage device according to some embodiments of the present disclosure. [Figure 9C] This figure shows a method for creating an intraocular drainage device according to some embodiments of the present disclosure. [Figure 10A] This is a cross-sectional view showing an intraocular drainage device according to some embodiments of the present disclosure. [Figure 10B] This is a top view showing an intraocular drainage device according to some embodiments of the present disclosure. [Figure 11] This is a cross-sectional view showing an intraocular drainage device according to some embodiments of the present disclosure. [Figure 12] This is a three-dimensional view showing an intraocular drainage device according to some embodiments of the present disclosure. [Figure 13] This is a three-dimensional view showing an intraocular drainage device according to some embodiments of the present disclosure. [Figure 14] This is a cross-sectional view showing an in-situ intraocular drainage device in a patient's eye, according to some embodiments of the present disclosure. [Figure 15] This is a three-dimensional view showing an intraocular drainage device disposed within an inserter device according to some embodiments of the present disclosure. [Figure 16] This is a three-dimensional view showing an intraocular drainage device according to some embodiments of the present disclosure. [Figure 17] This is a three-dimensional view showing a curved profile intraocular drainage device according to some embodiments of the present disclosure. [Figure 18] This is a three-dimensional view showing a linear profile intraocular drainage device according to some embodiments of the present disclosure. [Figure 18A]A three-dimensional view showing the intraocular drainage device of FIG. 18 having an additional fixation member. [Figure 19] A side view of the intraocular drainage device of FIG. 18. [Figure 20] A front view showing the intraocular drainage device of FIG. 18 disposed within the needle of an inserter device. [Figure 21] A three-dimensional view showing an intraocular drainage device according to some embodiments of the present disclosure. [Figure 22] A side view of the intraocular drainage device of FIG. 21. [Figure 23] A front view showing the intraocular drainage device of FIG. 21 disposed within the needle of an inserter device. [Figure 24A] A cross-sectional view showing an implantation procedure using an inserter device according to some embodiments of the present disclosure. [Figure 24B] A cross-sectional view showing an implantation procedure using an inserter device according to some embodiments of the present disclosure. [Figure 24C] A cross-sectional view showing an implantation procedure using an inserter device according to some embodiments of the present disclosure. [Figure 24D] A cross-sectional view showing an implantation procedure using an inserter device according to some embodiments of the present disclosure. [Figure 24E] A cross-sectional view showing an implantation procedure using an inserter device according to some embodiments of the present disclosure. [Figure 25A] A cross-sectional view showing an implantation procedure using an inserter device according to some embodiments of the present disclosure. [Figure 25B] A cross-sectional view showing an implantation procedure using an inserter device according to some embodiments of the present disclosure. [Figure 25C] A cross-sectional view showing an implantation procedure using an inserter device according to some embodiments of the present disclosure. [Figure 25D] A cross-sectional view showing an implantation procedure using an inserter device according to some embodiments of the present disclosure. [Figure 25E] A cross-sectional view showing an implantation procedure using an inserter device according to some embodiments of the present disclosure. [Figure 26] A top view showing an inserter device according to some embodiments of the present disclosure. [Figure 27A] A cutaway view showing an inserter device at a certain stage of surgery according to some embodiments of the present disclosure. [Figure 27B] A cutaway view showing an inserter device at a certain stage of surgery according to some embodiments of the present disclosure. [Figure 27C] A cutaway view showing an inserter device at a certain stage of surgery according to some embodiments of the present disclosure. [Figure 27D] A cutaway view showing an inserter device at a certain stage of surgery according to some embodiments of the present disclosure. [Figure 28A] A side view showing an inserter device at a certain stage of surgery according to some embodiments of the present disclosure. [Figure 28B] A side view showing an inserter device at a certain stage of surgery according to some embodiments of the present disclosure. [Figure 28C] A side view showing an inserter device at a certain stage of surgery according to some embodiments of the present disclosure. [Figure 28D] A side view showing an inserter device at a certain stage of surgery according to some embodiments of the present disclosure. [Figure 29A] A schematic view showing an inserter device during an implantation procedure according to some embodiments of the present disclosure. [Figure 29B] A schematic view showing an inserter device during an implantation procedure according to some embodiments of the present disclosure. [Figure 29C] A schematic view showing an inserter device during an implantation procedure according to some embodiments of the present disclosure. [Figure 30A] A three-dimensional view showing an inserter device according to some embodiments of the present disclosure. [Figure 30B]Figure 30A is a cutaway diagram of the inserter device. [Figure 30C] This is a partial plan view showing the inserter device of Figure 30A, which has a gripping member. [Figure 31A] This is a three-dimensional diagram showing inserter devices according to some embodiments of the present disclosure. [Figure 31B] Figure 31A is a cutaway diagram of the inserter device. [Figure 31C] Figure 31A is a cutaway plan view of the inserter device. [Figure 32] This is a three-dimensional diagram showing inserter devices according to some embodiments of the present disclosure. [Figure 33] This is a three-dimensional diagram showing inserter devices according to some embodiments of the present disclosure. [Figure 34A] This is a three-dimensional view showing an intraocular drainage device assembly according to several embodiments of the present disclosure. [Figure 34B] Figure 34A is a partial three-dimensional view showing an intraocular drainage device assembly. [Figure 34C] Figure 34A is a three-dimensional view showing the drainage device of the intraocular drainage device assembly. [Modes for carrying out the invention]

[0004] The following detailed description provides specific details to facilitate understanding of the subject art. However, it will be apparent to those skilled in the art that the subject art may be carried out without some of these specific details. In other examples, well-known structures and techniques are not shown in detail so as not to interfere with the subject art.

[0005] Intraocular implantation system According to some embodiments, for example, as shown in Figure 1, an inserter device 250 can be used to implant an intraocular drainage device 100 into a patient's eye 101.

[0006] As shown in Figure 1, a medical or surgical instrument, such as an inserter device 250, may include a handle 254 configured to be grasped by the surgeon's hand or another operator, and an actuator 252 disposed on the handle 254 and configured to actuate an internal mechanism within the inserter device 250 to release the intraocular drainage device 100 from the distal end of the inserter device 250. The distal end of the inserter device 250 may include a needle 253 configured to puncture the tissue of the eye 101 and / or to accommodate the drainage device 100 before release.

[0007] The actuator 252 can be implemented as any suitable mechanism that allows an operator to operate the actuator and release the drainage device 100. Examples of actuators 252 include a push button, a slider, a twist sleeve, a contact-sensitive electronic button, and / or any other suitable component that an operator can operate to activate an internal mechanism within the inserter device 250. When actuated by the actuator 252, the internal mechanism can be configured to release the drainage device 100 by pushing the drainage device 100 distally from the needle 253, leaving the drainage device 100 in place at the intended target site (e.g., the intraocular position in the patient's eye 101), and / or by retracting the needle 253 or another sleeve proximal around the drainage device 100.

[0008] According to several embodiments, an intraocular device such as an intraocular drainage device 100, as shown in Figure 1, may include a body 102 and a tube 106. The tube 106 may have a lumen, and as shown in Figure 1, the tube 106 may have a proximal end configured to be coupled to the body 102. The tube 106 may be formed integrally with the body 102 as a single piece, or the tube 106 may be manufactured as a separate component that is inserted into the body 102 or attached in another way (e.g., at the distal end of the body 102) to fluidly couple to the body 102. The distal end of the tube 106 may be inserted into the patient's lumen (e.g., the anterior chamber of the eye 101) to fluidly couple to the lumen. The tube 106 may be implemented as an input tube having a channel for inflow flow (e.g., a channel entering the distal end of the tube 106). This specification describes an example in which the drainage device 100 includes both a tube 106 and a body 102, but other embodiments can be conceived in which the drainage device 100 includes only the tube 106 or only the body 102.

[0009] According to some embodiments, the components of the drainage device 100, such as the body 102 and / or tube 106, may be flexible and may be made from a biocompatible flexible material such as silicone and / or hydrophilic or hydrophobic acrylic. In addition to or instead, it is conceivable that any of a variety of other materials may be suitable. Furthermore, while examples are described herein in which the body 102 and tube 106 are flexible and made from a flexible biocompatible material, other examples of implementation using rigid materials are conceivable.

[0010] According to some embodiments, the tube 106 and / or body 102 may include features that reduce the risk of hypointraocular pressure (low intraocular pressure that increases the likelihood of ocular complications that may occur due to excessive aqueous humor drainage). For example, the tube 106 and / or body 102 may include valves, flow-restricting lumens, and / or other mechanisms that reduce the risk of hypointraocular pressure.

[0011] According to some embodiments, as shown in Figure 2, for example, the drainage device 100 may be surgically implanted between the sclera 113 and conjunctiva 114 of the patient's eye 101 to provide an aqueous shunt that can reduce IOP, for example, for the treatment of glaucoma or other conditions. According to some embodiments, the drainage device 100 may be implanted in the anterior chamber 115 of the eye 101 using an inserter device 250 and also using an ab externo procedure. For example, during implantation, a needle 253 may be inserted through the sclera 113 to form a scleral tract, and the distal tip of the needle 253 may be inserted through the sclera 113 into the anterior chamber 115. The actuator 252 may then be operated to retract the needle or otherwise release the drainage device 100, leaving the implanted portion of the drainage device 100 in the scleral tract. After the inserter device 250 is removed, a portion of the implanted tube 106 may extend through the scleral pathway, connecting the anterior chamber 115 to a conjunctival pocket or a sub-Tenon's pocket. The drainage device 100 may be implanted such that aqueous humor or other fluid flows through the device 100 (e.g., in the direction of fluid flow as indicated by arrow 111), exits through one or more outlet ports, and is absorbed into the surrounding tissue (e.g., via the suprascle venous system). In other embodiments, the device may be implanted by an intraocular approach, which involves accessing the anterior chamber through a clear corneal incision, advancing a needle to a suitable quadrant, puncturing an angle near the scleral promontory, advancing an introducer (e.g., inserter device 250) into the sub-Tenon's space, and then retracting the introducer, leaving the drainage device in place to drain the fluid from the anterior chamber into the sub-Tenon's space. Similar approaches may be used, from an intraocular or extraocular approach, to introduce a drainage device into the superior choroidal space, connect one ocular compartment to another, or connect one ocular compartment to extraocular space, including transconjunctival, translimbal, or transcorneal outflow pathways.

[0012] Figure 2 schematically shows a cross-sectional view of an intraocular drainage device 100, which is disposed in situ within a patient's eye 101 such that the main body 102 is positioned between the sclera 113 and conjunctiva 114 of the patient's eye. The region between the sclera 113 and conjunctiva 114 can form a conjunctival pocket that secures the main body portion 102 of the drainage device. According to some embodiments, the main body 102 may be embedded in the sub-Tenon's space between the sclera 113 and conjunctiva 114. As shown, the tube 106 may extend through the sclera 113 so that aqueous humor in the anterior chamber 115 of the eye (partially bordered by the cornea 117, lens 118, and iris 119) can flow into the lumen of the tube 106 (as indicated by arrow 111). As shown in Figure 2, the fluid flowing through the device 100 may form vesicles 121 on and / or around the device 100 that can be absorbed by the patient's skin. Thus, the excessive fluid pressure in the anterior chamber 115 associated with the symptoms of glaucoma may be relieved.

[0013] Drainage device According to several embodiments, as shown in Figure 3, for example, the drainage device 100 may have an inlet port 125 and a plurality of outlet ports 127. The inlet port 125 may be configured to receive an inflowing fluid, such as aqueous humor flowing in from the anterior chamber of the eye, and the outlet ports 127 may be configured to discharge an outflowing fluid, such as aqueous humor flowing into a vesicle or other patient tissue. The inlet port 125 may be located, for example, at the distal end of a tube 106 and may be configured to contact the anterior chamber and receive aqueous humor.

[0014] The drainage device 100 can be implemented as a manifold through which lumens or other fluid pathways (not shown in Figure 3) extend, allowing the inlet port 125 to be fluidly connected to various outlet ports 127. The ports and lumens can be configured such that the inlet port 125 connects to an inlet lumen that branches to multiple outlet lumens or other outlet fluid pathways terminating at multiple surplus outlet ports 127. Each lumen may provide a substantially tubular fluid pathway that extends at least partially through the interior of the drainage device 100. The use of multiple outlet ports and fluid pathways can provide various outlet points for the fluid if, for example, one or more of the outlet ports 127 are obstructed (e.g., by patient tissue). The use of multiple outlet ports may also allow the fluid to flow simultaneously into the subtenon's capsule space and the subconjunctival space. For example, the outlet ports 127 may be configured such that, when implanted in the eye, one or more of the outlet ports 127 contact the subtenon space or allow fluid to flow in in another way, and one or more of the other outlet ports 127 contact the subconjunctival space or allow fluid to flow in in another way. According to some embodiments, the inlet lumen may provide a single inflow channel for delivering fluid flow before reaching multiple outlet lumens and outlet ports 127, so that the inlet lumen can adjust the IOP by primarily limiting the flow rate. However, in various embodiments, the size and number of outlet lumens may also define the pressure drop of the drainage device. According to some embodiments, for example, the inlet lumen may have a smaller diameter than one, some, or all of the outlet lumens so that the inlet lumen can primarily limit the fluid flow. However, other realizations can be conceived in which the inlet and outlet lumens have any suitable diameters that can be the same or different from each other in any suitable way that allows fluid to flow through the drainage device 100.

[0015] In some embodiments, the inlet lumen can be oriented transversely to one, some, or all of the outlet lumens connected to the outlet port. For example, one, some, or all of the outlet lumens may be oriented within a range of approximately 90° (perpendicular) to 45° with respect to the direction of the inlet lumen, with reference to the direction of fluid flow. An example of such a 45° arrangement is shown in Figures 9A-9C later. While examples of orientation are described, other realizations can be conceived in which other angles and orientations with respect to the lumen or fluid path may be used.

[0016] According to some embodiments, the outer surface of the main body 102 can be coated with a biodegradable material such as polyvinyl alcohol or poly(lactic acid-glycolic acid copolymer) (PLGA). The biodegradable material may be coated to cover the ports of the main body, such as all of the outlet port 127, to initially occlude the holes and prevent fluid flow through the device during the initial postoperative healing period. Over time, the coating degrades, exposing the ports and other outer surface features, and after the initial postoperative period has elapsed, the fluid pathway may be opened, allowing fluid to drain through the drainage device 100. In some embodiments, the PLGA or other biodegradable coating may contain anti-fibrotic or anti-inflammatory molecules such as steroids or rapamycin. In some embodiments, one or more lumens of the device are coated with a hydrophilic material to facilitate fluid transport. In other embodiments, the lumens and / or the entire device are coated with heparin or other material to reduce in-situ thrombus formation within or on the device.

[0017] Although the description includes an example in which the drainage device 100 includes multiple outlets, other implementations can be conceivable that include only one outlet port or only one lumen.

[0018] In some embodiments, as shown in Figure 3, for example, the main body 102 can be positioned proximal to the tube 106 and its size can be expanded relative to the tube 106. Thus, the tube 106 can provide a neck region of the device 100, which is narrower overall than the main body region 102 and positioned distal to the main body 102. In some embodiments, the inlet port 125 may be connected to an inlet lumen that extends at least partially through the neck region in the distal portion of the device 100. In addition to or instead of this, multiple outlet ports 127 may be connected to multiple outlet lumens, or to other outlet fluid pathways that branch off from the inlet lumen and extend at least partially through the main body 102 in the proximal portion of the device. During implantation, the main body 102 can be retained, for example, in a conjunctival pocket and positioned adjacent to surrounding tissues such as the outer surface of the sclera and / or the inner surface of the conjunctiva.

[0019] According to several embodiments, as shown in Figure 3, for example, a body 102 can be realized with a plate-like structure defining a short axis and a long axis, both of which may traverse the longitudinal axis of the drainage device 100, defined by the direction of the inflow fluid flow at the inlet port 125. The size of the body 102 in the long axis direction may be larger than the size of the body 102 in the short axis direction to result in a plate-like structure, which may promote vesicle formation within the conjunctival pocket. When implanted, the body 102 may be placed in the pocket such that the long axis extends transversely to the scleral surface and the short axis extends normal to the scleral surface. However, other realizations in which the body 102 does not have a plate-like structure can be conceived. For example, the body 102 may have any other suitable shape or size, such that its outer diameter or circumference is larger than the outer diameter or circumference of the tube 106, and can be expanded relative to the tube 106.

[0020] In some embodiments, the outer surface of the body 102 may include an upper surface 136 and a lower surface (not shown in Figure 3) opposite the upper surface. A side wall surface 137 may be disposed between the upper and lower surfaces. In some embodiments, the lower surface may be concave, for example, so that the concave shape conforms to the convex shape of the scleral surface, and may face the scleral surface. The upper surface 136 may be convex, for example, so that the convex surface conforms to the concave internal shape of the conjunctival surface, and may face the conjunctiva. Other realizations can be conceived in which the upper and / or lower surfaces may be flat or have other contour geometric shapes.

[0021] In some embodiments, as shown in Figure 3, for example, the outlet ports 127 can be distributed along the sidewall surface 137 and the proximal end of the main body 102. While examples are described in which the outlet ports are distributed along the sidewall and / or distal end of the main body 102, other implementations can be conceivable in which the outlet ports 127 can be arranged as a whole on one or more of the top surface 136, bottom surface, sidewall surface 137, and / or proximal surfaces at the proximal end of the device 100. In some embodiments, the outlet ports 127 can be distributed across multiple locations on the outer surface of the device 100 to reduce the possibility of localized blockages that obstruct all of the outlet ports 127.

[0022] According to some embodiments, the outer surface may include grooves such as microgrooves 141, 142, and / or 143, as shown in Figure 3, for example. As shown in Figure 3, microgroove 141 may be disposed on the body 102 and extend along the outer upper surface 136 and / or lower surface. Microgroove 142 may be disposed on the body 102 and extend along the side wall surface 137. Some or all of the microgrooves, such as microgroove 142 shown in Figure 3, may extend, for example, in the region between the outlet ports 127. As shown in Figure 3, microgrooves 141 and / or 142 may extend substantially parallel to each other in a longitudinal direction which may be substantially the same as the direction of the inflow fluid flow. The microgroove patterns 141 and / or 142 may, for example, assist the healing response of the eye over time after implantation, and / or improve the function of the device. For example, in some embodiments, surface patterning including grooves such as microgrooves 141 and 142 can be used to enhance, i.e., prevent, cell or bacterial adhesion to the implanted device. In addition to or instead of this, the microgroove pattern may be provided to help organize cells into controlled alignment along the implant. In the illustrated examples, only a few microgrooves are shown for illustrative purposes. However, in various implementations, one, two, three, four, tens, hundreds, or thousands of microgrooves may be formed to substantially cover a surface, for example, the top surface 136, the bottom surface, the side wall surface 137, and / or any other desired surface.

[0023] As shown in Figure 3, the microgrooves 143 may be included in the neck region and located distal to the microgrooves 141 and / or 142 of the body region 102. The microgrooves 143 may extend substantially perpendicular to the microgrooves 141 and / or 142. For example, the microgrooves 143 may extend circumferentially around the tube 106 in a direction substantially perpendicular to the direction of fluid flow, while the microgrooves 141 and / or 142 may extend longitudinally along the body 102 substantially parallel to the direction of fluid flow. According to some embodiments, the vertical microgrooves 143 may be implemented as a retention mechanism to facilitate device retention and minimize device displacement when implanted in the intraocular position. In some embodiments, the vertical microgrooves 143 may be relatively larger than the microgrooves 141 and / or 142. For example, each microgroove or microgroove pattern may be formed in equally spaced rows. Each microgroove may have a width, depth, and spacing from adjacent microgrooves. According to some embodiments, the microgrooves 141 and / or 142 may each have a width, depth, and / or spacing from adjacent microgrooves in the range of about 10 to 40 microns (for example, in one embodiment, each is equal to about 25 microns). In contrast, the microgrooves 143 may each have a width, depth, and spacing greater than about 40 microns, such as in a range of about one to two orders of magnitude larger than that of the microgrooves 141 and / or 142 (for example, in one embodiment, it is equal to about 635 microns). While examples with specific dimensions are described, it should be understood that other embodiments with dimensions outside these ranges can be conceived. According to some embodiments, the microgroove pattern may be formed by laser patterning of the surface of the drainage device 100 or by any other suitable method for creating a surface pattern.

[0024] According to some embodiments, as shown in Figures 4-7, for example, the drainage device 100, such as the drainage device tube 106, may include one or more retention mechanisms instead of, or in addition to, the circumferential microgrooves 143. The retention mechanisms may, for example, facilitate the retention of the drainage device 100 at the implantation site and / or minimize the displacement of the drainage device 100 without the need for sutures.

[0025] According to some embodiments, one or more retention fins 144 may be included in the tubular region 106 of the drainage device 100, for example, as shown in Figure 4. As shown in Figure 4, the retention fins 144 may be implemented as angled returns toward the proximal end of the main body 102. Proximal orientation may facilitate distal insertion into or between patient tissues. In addition to or instead of this, proximal angled orientation may help reduce the tendency of the implanted device to displace proximal in a manner that allows the drainage device 100 to be removed from the anterior chamber after implantation.

[0026] According to some embodiments, for example as shown in Figure 5, the distal end of the tube 106 may include an orifice attachment portion 145 to facilitate retention of the device 100. The distal end of the orifice attachment portion 145 may include a radially flared portion to facilitate retention when the distal end is inserted into the anterior chamber of the eye.

[0027] According to some embodiments, the body 102 may include a contour profile such as an hourglass shape, as shown in Figure 6, for example. The hourglass shape may include a neck region, and the portion of the device 100 at the opposite end of the neck region is expanded outward or has an increased diameter compared to a relatively narrow neck portion. For example, not only may the body 102 be larger in size than the neck region, but the distal end of the tube 106 on the opposite side of the neck region may also be larger in size than the neck and expanded relative to the neck. According to some embodiments, as shown in Figure 6, for example, the expanded distal end of the tube 106 may be smaller (e.g., in diameter or cross-sectional area) than the largest portion of the body 102 on the opposite side of the neck.

[0028] According to some embodiments, for example as shown in Figure 7, the tube 106 may include a retaining ridge 146 to facilitate the retention of the embedded body.

[0029] According to several embodiments, the manufacture of the intraocular drainage device 100, which may be a very small manifold structure, can be carried out using a two-part structure, as shown in Figures 8A and 8B, for example. As shown in Figures 8A and 8B, the drainage device 100 may include a distal compartment 161 and a proximal compartment 162. The distal compartment 161 may correspond to, for example, a tube 106, and the proximal compartment 162 may correspond to, for example, a body 102. The proximal end of the distal compartment 161 may be joined to the distal end of the proximal compartment 162. The distal compartment 161 may include an inlet lumen 165 which is fluid-coupled to an internal port 166 exposed at the proximal end of the distal compartment. The proximal compartment 162 may include a plurality of outlet lumen 168 which are fluid-coupled to a plurality of internal ports 169 exposed at the distal end of the proximal compartment 162. As shown in Figures 8A and 8B, for example, multiple internal ports 169 can be recessed relative to the distal end of the proximal compartment 162 so that when the distal compartment 161 and the proximal compartment 162 are joined together, a distribution chamber 170 can be formed between the inlet lumen 165 and the multiple outlet lumen 168. In other implementations, the internal port 166 may be recessed relative to the proximal end of the distal compartment 161, or both the internal port 166 and the multiple internal ports 169 may be recessed relative to their respective ends so that when joined together, a distribution chamber 170 can be formed.

[0030] According to several embodiments, as shown in Figures 9A-9C, for example, the drainage device 100, or components of the drainage device 100 such as the main body 102, can be manufactured using a soluble core 172 (e.g., a core made of a water-soluble material) to form a multi-lumen or manifold structure. For example, as shown in Figure 9A, the soluble core 172 can be formed into a pattern having a first extending member 173 which can correspond to a desired inlet lumen in the final configuration, and a plurality of second extending members 174 branching from the first extending member which can correspond to a desired plurality of branched outlet lumen in the final configuration. The second extending members may be oriented, for example, at an angle of 45-90° (45° in Figure 9A) with respect to the first extending member, or in any other desired manifold geometry. As shown in Figure 9B, for example, a portion 131 which can correspond to the main body 102 or the entire drainage device 100 can be molded onto the soluble core 172. The molded portion 131 may be made of any suitable material that is not soluble in the same solvent used to dissolve the core 172. For example, the core 172 may be made of a water-soluble material, and the molded portion 131 may be made of a water-insoluble material. As shown in Figure 9C, for example, the soluble core 172 may be dissolved in a solvent (e.g., water) and left to remain, and the core may be replaced with a manifold structure containing an inlet lumen 165 and multiple outlet lumen 168 corresponding to the pattern of the initial core 172.

[0031] According to some embodiments, for example, as shown in Figure 10A, the multiple lumen structure may be formed by arranging multiple small tubes 175 side by side and connecting them to one another. The side-by-side geometric shape may also facilitate the formation of a plate-like geometric shape in the body 102 of the drainage device 100, in which case the tubes 175 can be arranged side by side along the long axis of the plate-like body.

[0032] According to some embodiments, the drainage device 100, such as the main body region 102, may include a plurality of polygons 132, as shown in Figure 10B, for example. The polygons 132 may be arranged in series at regular intervals to form a plurality of outlet lumens 168 (e.g., fluid paths) in the intervening spaces between the polygons 132. In this example, the fluid paths do not necessarily have to be in the form of lumens or tubular paths extending through the structure.

[0033] Although various examples of the structure of the drainage device 100 are described, it is conceivable that the drainage device 100 can be manufactured using other methods.

[0034] According to some embodiments, the drainage device 100 may include a tube 106 having a lumen 176 that serves as a fluid transport path, as shown in Figure 11, for example. A sponge substrate may be placed inside the lumen 176 to facilitate flow rate limiting. A tube 106 having a sponge substrate may be used instead of, or in addition to, the multi-lumen structure described herein.

[0035] According to some embodiments, for example as shown in Figure 12, the drainage device 100 may include a tube 106 having an end with a coil that can provide a circumferential corrugation that serves as a retention mechanism. In addition to or instead, the coil may be made of a shape memory material having a predetermined curvature, configured to conform to the curvature of the sclera, so that it remains straight when the tube 106 is housed in the inserter device 250 (e.g., in the needle 253), but can bend to conform to the curvature when it is discharged from the inserter device 250 (e.g., discharged from the needle 253).

[0036] According to some embodiments, the tube 106 may have a circular cross-sectional shape, as shown in Figure 13, for example. In addition to or instead of this, the tube 106 may have any of various other cross-sectional shapes, such as D-shaped or elliptical.

[0037] According to some embodiments, for example as shown in Figure 13, the tube 106 may include multiple sets of retention mechanisms, such as a first retention member 180 and a second retention member 181 which can be disposed proximal to the first retention member 180. As shown in Figure 13, for example, the first retention member 180 may include one or more fins projecting radially outward from the outer surface of the tube 106. The fins may include a stop surface 183 on their proximal side, which can be configured to contact patient tissue and / or device components during and / or after the implantation procedure to prevent the tube 106 from moving proximal backward. In addition or instead, the distal side of the fins may include an inclined surface 184 that can slide in contact with patient tissue during implantation and / or expand an opening in the patient tissue to facilitate the deployment of the tube 106 or the distal end of the tube 106 through the patient tissue. As shown in Figure 13, for example, the inclined surface 184 can form an obtuse angle with respect to the outer surface of the tube 106. In addition or instead, the stopping surface 183 can have an angle of 90° or less (for example, forming a perpendicular or acute angle with respect to the outer surface of the tube 106). Figure 13 shows an example in which the first retaining member 180 includes a pair of separate fins disposed on the opposing surfaces of the tube 106. However, other realizations can be conceived in which one or more fins are included in any appropriate number (e.g., one fin, two fins, three fins, five fins, ten fins, etc.), or in which the fins are made continuously so as to extend circumferentially around the tube. Although examples have been described in which the stopping surface 183 and the inclined surface 184 are substantially flat, other realizations can be conceivable in which one or more of these surfaces are curved and / or have other geometric shapes. Furthermore, although specific angles and ranges are described, other implementations can be conceivable in which these surfaces may form angles other than those specified or ranges.

[0038] According to some embodiments, for example as shown in Figure 13, the second retaining member 181, which is disposed proximal to the first retaining member 180, may include a friction-enhancing mechanism, such as a circumferentially extending ridge.

[0039] Figure 14 is a cross-sectional view of an eye 101 showing in situ the drainage device 100 according to the implementation shown in Figure 13, when implanted in the patient's eye 101. As shown in Figure 14, for example, the distal end of the tube of the drainage device 100 is positioned within the anterior chamber 115 of the patient's eye 101. The tube of the drainage device 100 can be positioned through the scleral tract 186 so that a first retaining member 180 (e.g., a fin) can be positioned within the anterior chamber 115. The proximal side of the first retaining member, such as the stopping surface 183, can be positioned adjacent to patient tissue, such as the trabecular meshwork 187, to prevent proximal movement or displacement of the tube so that the tube 106 maintains fluid coupling with the anterior chamber 115. The distal side of the first retaining member 180, such as the inclined surface 184, may be positioned to allow the tube to slide through an opening in the patient tissue.

[0040] As shown in Figure 14, for example, the second retaining member 181 can be positioned outside the anterior chamber 115 and retained adjacent to the scleral tissue of the sclera 113. The second retaining member 181 may facilitate retention by, for example, increasing friction between the second retaining member 181 and the scleral surface. As shown in Figure 14, once the drainage device 100 is implanted, the second retaining member can be retained within the scleral passage 186. In addition to or instead of this, the second retaining member can be retained adjacent to other tissues, such as the scleral tissue in the conjunctival pocket between the conjunctiva 114 and the sclera 113.

[0041] According to several embodiments, as shown in Figure 15, for example, a first retaining member 180, such as a retaining fin, can be used in addition to or instead to facilitate the retention of the tube 106 while the drainage device 100 is deployed during the implantation procedure. For example, a stop surface 183 can abut against the distal side of the needle 253 of the inserter device 250 so that the drainage device remains housed within the needle while the needle 253 moves distally. The distal movement of the needle can also be used to form a scleral pathway 186 as the needle 253 is advanced through the sclera 113 into the anterior chamber 115. The drainage device 100 can be discharged from the inserter device 250 by retracting the needle 253, for example, with the proximal surface of the first retaining member 180 abutting against patient tissue to hold the tube 106 in place. During the implantation procedure, fins can be positioned in their respective slots 201 contained in the distal tip of the needle 253. The slot 201 may allow the first retaining member 180 to contact the distal end of the needle 253 without the tube 106 protruding from the distal end of the needle 253. However, other implementations can be conceived in which the slot 201 is omitted.

[0042] According to some embodiments, as shown, for example in Figure 16, the tube 106 may provide a drainage device without requiring a multi-lumen body. In such embodiments, the tube 106 may provide a shunt having a single lumen terminating proximal to drain, for example, into a conjunctival pocket. According to some embodiments, as shown, for example in Figure 16, the proximal end may include a plate 189 which can help separate the conjunctiva from the sclera. In addition to or instead of this, the plate 189 may help maintain vesicles. The plate 189 may be realized, for example, by a silicone ring as shown in Figure 16. The plate 189 may be, for example, disposed on one side of the tube and may be a substantially solid or monolithic structure that does not have an internal lumen containing fluid flow. Alternatively, other realizations in which the plate 189 is omitted can be conceived.

[0043] According to several embodiments, a drainage device 100a is provided. For example, as shown in Figure 17, the drainage device 100a may have a curved profile including a body 102a and a tube 106a. The curvature may be configured to conform to the contour of the eye, for example, a curvature of 2.54 mm in diameter. The patterned area 105a of the tube 106a may include a plurality of retaining members 181a. For example, the patterned area 105a may be a large vertical pattern configured to retain the drainage device 100a within the sclera 113 of the eye 101 so as to prevent or hinder the drainage device 100a from moving forward or backward after insertion into the eye 101. A plurality of outlet ports 127a are provided on the combined body 102a and tube 106a. For example, as shown in Figure 17, one outlet port 127a may be provided at the front end of the tube 106a, or three outlet ports 127a may be provided on each side of the body 102a. The inlet port 125a is routed through the interior of the main body 102a. As described above, the outlet port 127a of the main body 102a may be routed perpendicular to the inlet port 125a or at a certain angle (e.g., 45°), as shown in Figure 17, and the outlet port 127a at the front end of the tube 106a may be in line with the inlet port 125a. The main body 102a may include one or more slots 150a (e.g., trenches) configured to protect the outlet ports 127a routed within the main body 102a. For example, some of the outlet ports 127a may be routed within the slots 150a so that the slots 150a become drainage channels along the slots or trenches 150a as tissue grows and potentially blocks the individual outlet ports 127a.

[0044] According to several embodiments, a drainage device 100b is provided. For example, as shown in Figures 18-20, the drainage device 100b includes a body 102b and a tube 106b. The patterned area 105b of the tube 106b may include a plurality of retaining members 180b and 181b. For example, the retaining member 180b may be a radial fin projecting outward at a certain angle, and the retaining member 181b may be a rib extending outward in a vertical direction. The number and size of the ribs 181b may be provided to suit specific characteristics. For example, a small number of large ribs 181b can simplify or streamline manufacturing and increase the integrity of the patterned area 105b (e.g., the retaining mechanism). The retaining members 180b and 181b may extend outward and be configured to match the outer profile (e.g., width, diameter) of the body 102b. The patterned range 105b may be configured to retain the drainage device 100b within the sclera 113 of the eye 101 so as to prevent or hinder the drainage device 100b from moving forward or backward after insertion into the eye 101. For example, the retaining member 180b may be configured to fit within the pathway or just inside the anterior chamber 115 of the eye 101. The retaining member 181b may be compressible along the longitudinal axis of the drainage device 100b. For example, the retaining member 181b may be compressed while positioned within the needle 253 to shorten the length of the drainage device 100b, and may expand or spring back to an uncompressed state after the needle 253 is inserted and retracted.

[0045] As shown in Figure 18A, the movable retaining member 185 may be positioned on the body 102b and / or tube 106b adjacent to the beginning and / or end of the retaining member 181b. The movable retaining member 185 may be a flexible arm integrated with the corresponding body 102b or tube 106b, or a separate component coupled to the corresponding body 102b or tube 106b. The movable retaining member 185 may be compressed inward (e.g., by tightening the body 102b or tube 106b) with the drainage device 100b positioned within the insertion device, or the movable retaining member 185 may spring back open after insertion into the eye 101 (e.g., by springing back open on either side of the scleral thickness across the perforation) to further retain the drainage device 100b within the sclera 113.

[0046] As shown in Figure 18, one outlet port 127b may be located at the front end of the tube 106b, or three outlet ports 127b may be located on each side of the body 102b. The inlet port 125b is located inside the body 102b. As described above, the outlet port 127b of the body 102b may be located perpendicular to the inlet port 125b or at an angle (e.g., 45°) as shown in Figure 18, and the outlet port 127b at the front end of the tube 106b may be in line with the inlet port 125b.

[0047] As shown in Figure 20, the drainage device 100b is configured to fit into the needle 253 of the inserter device 250. The size and shape of the retaining members 180b and 181b are determined so as not to exceed the outer profile of the body 102b, so the size of the needle 253 may be selected based on the profile of the body 102b. The drainage device 100b may have a straight profile as shown in Figures 18 and 19, or a curved profile as shown in Figure 17.

[0048] According to several embodiments, a drainage device 100c is provided. For example, as shown in Figures 21-23, the drainage device 100c includes a body 102c and a tube 106c. The patterned range 105c of the tube 106c may include a plurality of retaining members 181c. For example, the retaining members 181c may be twisted threads that extend outward beyond the outer profile (e.g., width, diameter) of the body 102c. The patterned range 105c may be configured to retain the drainage device 100c within the sclera 113 of the eye 101 so as to prevent or hinder the drainage device 100c from moving forward or backward after insertion into the eye 101. For example, the retaining members 181c may be configured to stretch the tissue of the eye 101, thereby efficiently housing and sealing the drainage device 100c within the scleral passage.

[0049] As shown in Figure 21, one outlet port 127c may be located at the front end of the tube 106c, or three outlet ports 127c may be located on each side of the body 102c. The inlet port 125c is located inside the body 102c, as shown in Figure 22. As described above, the outlet port 127c of the body 102c may be located perpendicular to the inlet port 125c or at an angle (e.g., 45°), and the outlet port 127c at the front end of the tube 106c may be in line with the inlet port 125c.

[0050] As shown in Figure 22, the drainage device 100c is configured to fit into the needle 253 of the inserter device 250. Since the retaining member 181c is sized and shaped to exceed the outer profile of the main body 102c, the size of the needle 253 may be selected based on the profile of the retaining member 181c. The drainage device 100c may have a straight profile as shown in Figures 21 and 22, or a curved profile as shown in Figure 17.

[0051] Each of the drainage devices 100, 100a, 100b, and 100c may include an orientation mechanism disposed on or integrally formed with the main body 102, 102a, 102b, and 102c or the tubes 106, 106a, 106b, and 106c. The orientation mechanism may be a visual indicator (e.g., color, texture, or pattern) that visually indicates the orientation of the drainage devices 100, 100a, 100b, and 100c after insertion into the eye 101 by indicating one or the other end (e.g., top or bottom, proximal or distal) of the drainage devices 100, 100a, 100b, and 100c.

[0052] Implantation procedure As described above, various implementations can be envisioned in which the intraocular drainage device 100 can be implanted at various locations in the eye, either from outside or inside the eye, using an insertion device such as the inserter device 250.

[0053] According to several embodiments, as shown in Figures 24A-24E and 25A-25E, for example, the implantation method may utilize an extraocular approach in which the needle 253 of the inserter device 250 is inserted through a conjunctival incision 202 and through the sclera 113 to form a puncture pathway 186 in the sclera 113 (the puncture pathway 186 may also be referred to herein as the “scleral pathway”). After the needle 253 has formed the scleral pathway 186, the distal tip of the needle 253 can enter the anterior chamber 115 to form a perforation for draining aqueous humor from the anterior chamber 115. The outflow pathway may extend through the same scleral pathway 186 that was formed as the needle 253 approached the anterior chamber 115. Although only one needle 253 is shown, embodiments can be conceived in which one or more needles or sleeves may be included in the inserter device 250, which may be individually operable by one or more actuators.

[0054] After implantation, the drainage device 100 can be released by retracting the needle 253, initially holding the distal end of the drainage device 100 within the anterior chamber 115 on the same side as the needle 253 was inserted into the eye 101. After implantation, the proximal end of the drainage device 100 can remain in the sub-Tenon's capsule space between the conjunctiva 114 and the sclera 113, more specifically between Tenon's capsule 199 and the sclera 113. The intermediate portion of the drainage device 100 between the distal and proximal ends remains within the scleral tract 186, allowing aqueous humor to be transported from the inlet port at the distal end of the drainage device 100 to one or more outlet ports at the proximal end of the drainage device 100. In some embodiments, to facilitate an extraocular implantation method, the drainage device 100 can be held within the needle 253 in an orientation such that the distal end of the drainage device 100, including the inlet port, initially faces the release port of the needle 253 at the distal tip of the needle, and the proximal end of the drainage device 100 faces away from the release port of the needle 253 and toward the handle 254 of the inserter device 250. In some embodiments, the inserter device 250 is configured to deliver a fluid (such as an ophthalmic viscoelastic agent) or a gas (such as air, SF6, or C3F6) to separate tissue surfaces before the injected drainage device 100 is implanted between the separate tissue surfaces (such as Tenon's capsule and the sclera).

[0055] Figures 24A–24E show an example of an implantation procedure involving a conjunctival incision 202, which is made closer to the edge 198 than the subtenon's space, or other retaining space in which a portion of the drainage device 100 is held. For example, as shown in Figures 24A–24E, the implantation procedure may include first inserting a needle 253 through the incision 202, and then manipulating the proximal portion of the device 100, such as the main body 102, to insert it into the subtenon's space through the same incision 202 from different angles.

[0056] As shown in Figure 24A, an incision 202 can be made in the conjunctiva 114 before inserting the needle 253. The incision 202 can be made, for example, about 3 millimeters (mm) away from the edge 198 of the eye 101, but it is conceivable that other locations may be more suitable for this incision. As shown in Figure 24A, the incision 202 can be made using a blade 203, such as a scalpel or other suitable surgical instrument, which may be separate from the inserter device 250. However, other realizations can be conceivable in which the inserter device 250 itself is used to make the initial incision 202. The incision 202 can be made through the conjunctiva 114 and also through Tenon's capsule 199 of the eye 101. Although Tenon's capsule 199 is shown as a separate layer in Figure 24A, it should be noted that in areas close to the edge 198, Tenon's capsule 199 may be integrated with the conjunctiva 114. The incision 202 may create or open a pocket between the conjunctiva 114 and the sclera 113 using a blade 203 or any other suitable tool to cut Tenon's capsule 199 from the episclera (the outermost layer of the sclera 113). Further as described later, the pocket may provide a space into which a portion of a drainage device 100, such as the main body 102, is later inserted and secured.

[0057] As shown in Figure 24B, the needle 253 of the inserter device 250 can be inserted into the incision 202. The needle 253 can be advanced distally through the sclera 113 to form a scleral pathway 186, and further advanced so that the distal tip of the needle 253 enters the anterior chamber 115 through the trabecular meshwork 187 or other ocular tissue sealing the anterior chamber 115. The needle 253 can be advanced distally, for example, by the surgeon or user moving the handle to advance the entire inserter device 250 including the needle 253 distally, and / or by operating the actuator to advance the needle 253 distally relative to the handle 254.

[0058] As shown in Figure 24C, the needle 253 can be retracted, leaving the intraocular drainage device 100 in place with its distal portion, such as the distal end of the tube 106, positioned within the anterior chamber 115. As shown in Figure 24C, by retracting the needle 253, a portion of the drainage device 100, such as the middle or proximal portion of the tube 106, can also be left in place within the scleral tract 186 previously formed by the distal movement of the needle 253. The needle 253 can be retracted, for example, by operating an actuator 252 (not shown in Figures 24A-24E) to activate an internal mechanism located within the handle and coupled to the needle 253. Figure 24C shows the partially retracted needle 253 with a portion of the drainage device 100 exposed and the rest of the drainage device 100 still held within the needle 253.

[0059] As shown in Figure 24D, after the needle 253 is retracted and exits the sclera 113 and the scleral pathway 186, a portion of the drainage device 100, such as all or part of the main body 102, can be inserted into the pocket between the conjunctiva 114 and the sclera 113. The drainage device 100 may be inserted into the pocket by further manipulating it using a tool 205, which may be the same inserter device 250 or a separate instrument. At this stage, the drainage device 100 may be manipulated by pivoting it or approaching the pocket in a different way at a different angle to the approach angle used by the needle 253 while forming the puncture pathway 186. According to some embodiments, a retention mechanism for the drainage device 100, such as the retention mechanism described above, may allow the drainage device 100 to remain in place without the need to suture the drainage device 100 to the tissue of the eye 101.

[0060] According to some embodiments, the drainage device 100 is flexible and can be housed in a compressed state within the needle. For example, the drainage device 100 may be crushed, folded, or otherwise compressed against the inner surface of the needle 253 so that it can have a smaller shape factor before being released into the intraocular space of the patient's eye 101. When the needle 253 is retracted and the drainage device 100 is released, the compression applied to the compressed portion of the drainage device is released, the compression of the drainage device 100 is released, and it may be possible for it to self-expand within the intraocular space (e.g., within the pocket) to become uncompressible with one or more dimensions greater than the diameter of the needle 253 (e.g., a larger diameter or a larger dimension along the long axis of the body 102). However, while examples of a flexible drainage device 100 being compressed have been described, other realizations can be conceivable in which the drainage device 100 is not compressed when held by the needle 253 and / or does not expand when released from the needle 253.

[0061] Figure 24E shows the drainage device 100 after insertion into the pocket. As shown in Figure 24E, the main body 102 or a portion of the main body 102 may be held in the subtenon's capsule space, and the tube 106 or a portion of the tube 106 may be held in the anterior chamber 115. The drainage device 100 can be retained such that one or more inlet ports of the drainage device 100 (not shown in Figure 24E) are in contact with the anterior chamber 115, and one or more outlet ports of the drainage device 100 (not shown in Figure 24E) are in contact with the space between the conjunctiva 114 and the sclera 113.

[0062] Figures 25A–25E show an example of an implantation procedure, which involves inserting a needle 253 through an incision 202, which is made away from the edge 198 from the space between the conjunctiva and sclera in which a portion of the implanted drainage device is held. For example, as shown in Figures 25A–25E, the implantation procedure may include first inserting a needle 253 through an incision 202 and then leaving a proximal portion of the drainage device 100, such as the body 102, in the subtenon space without substantially pivoting the inserter device 250 to leave the drainage device in the subtenon space by continuing to retract the needle.

[0063] For example, as shown in Figure 25A, the conjunctival incision 202 can be made, for example, at a distance of more than approximately 3 millimeters (mm) from the edge 198 of the eye 101, although it is conceivable that other locations may be more suitable for this incision. As shown in Figure 25A, the incision 202 can be a needle incision, made by inserting the needle 253 of the inserter device 250 through the conjunctiva 114. The incision 202 can be made through the conjunctiva 114 and also through Tenon's capsule 199 of the eye 101. The pocket between the conjunctiva 114 and the sclera 113 may be formed at this stage through the incision 202 in the space above the incision (closer to the edge 198 than the incision 202), or the procedure may proceed without the need to open the pocket at this stage.

[0064] As shown in Figure 25B, the needle 253 can be advanced distally through the sclera 113 to form a scleral pathway 186 and further advanced into the anterior chamber 115 through the trabecular meshwork 187 or other ocular tissue sealing the anterior chamber 115.

[0065] As shown in Figure 25C, the needle 253 can be retracted, leaving the intraocular drainage device 100 in place with its distal portion, such as the distal end of the tube 106, positioned within the anterior chamber 115. As shown in Figure 25C, by retracting the needle 253, a portion of the drainage device 100, such as the middle or proximal portion of the tube 106, can also be left in place within the scleral tract 186 previously formed by the distal movement of the needle 253. Figure 25C shows the partially retracted needle 253 with a portion of the drainage device 100 exposed and the rest of the drainage device 100 still held within the needle 253.

[0066] As shown in Figure 25D, after retracting the needle 253 and exiting the sclera 113 and the scleral pathway 186, the needle can be continued to leave a portion of the drainage device 100, such as all or part of the main body 102, in place within the retaining space between the conjunctiva 114 and the sclera 113. Thus, the initial incision can be considered to be below the retaining space of the drainage device, or further away from the edge 198. This may avoid the need to separately pivot or manipulate the drainage device 100 from different approach angles to fix it in the retaining pocket, for example. In addition or instead, this may provide a less invasive procedure than implementations that involve a separate operation to fix the drainage device 100 in the pocket from above. The retaining mechanism for the drainage device 100, such as the one described above, may allow the drainage device 100 to remain in place without the need to suture it to the tissue of the eye 101.

[0067] Figure 25E shows the drainage device 100 retained in space after needle retraction. As shown in Figure 25E, the main body 102 or a portion of the main body 102 may be retained in the sub-Tenon's capsule space, and the tube 106 or a portion of the tube 106 may be retained in the anterior chamber 115. The drainage device 100 can be retained such that one or more inlet ports of the drainage device 100 (not shown in Figure 25E) are in contact with the anterior chamber 115, and one or more outlet ports of the drainage device 100 (not shown in Figure 25E) are in contact with the space between the conjunctiva 114 and the sclera 113.

[0068] Inserter device According to some embodiments, for example as shown in Figure 26, the actuator 252 of the inserter device 250 may include a trigger button located on the side of the handle 254, which can be operated using the surgeon's thumb or index finger when the handle 254 is held, for example, using a pencil grip. In addition to or instead of this, the inserter device 250 may include a finger loop 211 located at the proximal end of the inserter device 250, opposite the distal end of the inserter device 250, which houses a needle 253 that can release the drainage device 100. The finger loop 211 may provide an ergonomic mechanism, for example, which the user can pull to create a vacuum in the vacuum chamber within the handle. The vacuum chamber may be configured to apply a vacuum force that retracts the needle 253 when the actuator 252 is pushed down. It should be understood that the vacuum described herein does not necessarily have to be a perfect vacuum and may generally include any suitable gap that allows a vacuum force to be applied by removing air and creating a pressure difference.

[0069] Figures 27A to 27D are cutaways of the inserter device 250 according to the implementation shown in Figure 19, in various illustrative operating stages. For example, as shown in Figures 27A to 27D, the inserter device 250 may include a handle 254 and a needle 253 disposed at the distal end of the handle 254. A front plunger 215 may be coupled to the needle 253 and disposed within the handle 254. The front plunger 215 may be fixedly attached to the needle 253, for example, directly or indirectly, so that the needle 253 moves together with the front plunger 215. The front plunger 215 may be disposed distal to the front vacuum chamber 219 so that a proximal force can be applied to the front plunger 215 by the vacuum created in the vacuum chamber 219, thereby causing the needle 253 to retract together with the front plunger 215.

[0070] Figures 27A–27D also show other components that may be included to create a vacuum within the inserter device 250 and facilitate the retraction of the needle 253 based on the vacuum. For example, a rear plunger 213 may be positioned proximal to the front plunger 215 and reciprocally oriented within the channel 221 so that the rear plunger 213 can translate forward and backward. The rear plunger 213 may be smaller than the front plunger 215, as shown, for example, in Figures 27A–27D. A charge compartment 233 may be positioned at the proximal end of the handle 254 and may be retractable proximal to the handle 254. Retraction of the charge compartment 233 may be configured to expand the rear vacuum chamber 218 to create a vacuum inside. The vacuum in the rear vacuum chamber 218 can be applied to the proximal force of the rear plunger 213 to move the rear plunger proximal in the channel 221, thereby creating a vacuum in the front vacuum chamber 219. A valve 229, such as a duckbill valve, can be coupled to the rear vacuum chamber 218 to release pressure when the charge compartment 233 is moved distally and comes into contact with the rear vacuum chamber 218. A finger loop 211 can be positioned in or otherwise coupled to the charge compartment 233 to facilitate retraction of the charge compartment 233 by pulling the finger loop. The front vacuum chamber 219 and the rear vacuum chamber 218 may each be sealed chambers (e.g., sealed with an O-ring or other sealing member).

[0071] Figure 27A shows the inserter device 250 during the packaging stage, which may correspond to the initial stage when the device 250 is delivered to the user. At this stage, the inside of the inserter device 250 does not have to be a vacuum, and therefore the inside of the anterior vacuum chamber 219 is not a vacuum. The needle 253 (e.g., a metal sleeve) and the anterior plunger 215 can be in an anterior or distal position. An intraocular drainage device (not shown in Figure 27A) can be held within the needle 253. The actuator 252 can be implemented at this stage as a trigger button supported in a locked position. The posterior plunger 213 can be positioned at this stage in an anterior distal position.

[0072] Figure 27B shows inserter device 250 in the charging phase, which can be used to create a vacuum within the device. During the charging phase, the user can retract the charging compartment 233 relative to the handle 254 (for example, by pulling the finger loop 211), thereby expanding the rear vacuum chamber 218 and creating a vacuum in the front and rear vacuum chambers, respectively. In particular, the vacuum created in the rear vacuum chamber 218 may be used to apply a proximal vacuum force to the rear plunger 213, thereby creating a vacuum in the front vacuum chamber 219 as the rear plunger 213 translates proximal in the channel 221. The vacuum in the front vacuum chamber 219 may be used to apply a proximal vacuum force to the front plunger 215, which can remain in the distal position as it is held in place by the trigger button actuator 252 or a mechanism coupled to the trigger button actuator.

[0073] Figure 27C shows the inserter device 250 in the operating phase. At this phase, the user can push the charge compartment 233 distally relative to the handle 254. This releases positive pressure through the valve 229. In addition to or instead of this, distal movement of the charge compartment 233 can release a safety device coupled to the trigger button actuator 252, allowing the trigger button to be pressed. The front plunger 215 and needle 253 can remain held in the forward distal position by the actuator 252 at this phase.

[0074] Figure 27D shows the inserter device 250 in the retraction phase. During the retraction phase, the user can press down the trigger button actuator 252 to release the anterior plunger 215, allowing it to translate proximal to the handle 254 and retract together with the needle 253 to expose the intraocular drainage device 100. In particular, the vacuum in the vacuum chamber 219 can apply a proximal vacuum force to the anterior plunger 215. This proximal vacuum force can be reacted by the trigger button when the trigger button is in the upper position, holding the anterior plunger 215 and needle 253 in place. By pressing the trigger button, this reaction force can be removed, allowing the plunger 215 and needle 253 to move proximal when the button is pressed.

[0075] According to several embodiments, for example as shown in Figures 28A-28D, the inserter device 250 may include an actuator 252, which is implemented as a sliding and pressable button coupled to a needle 253. The needle 253 may be translatable when the button is slid against the handle 254, and pressing the button can release the intraocular drainage device 100 from the needle 253. In various implementations, the sliding and pressable button may be operable to translate the needle 253 distally (extending), proximally (retracting), or both distally and proximal.

[0076] Figures 28A–28D show the inserter device 250, which has sliding and pressable buttons, at various stages of operation. Figure 28A shows the inserter device 250 in the initial stage, with the sliding and pressable button actuator 252 in an upper, proximal position, and the needle 253 also in a proximal position, holding the intraocular drainage device (not shown in Figure 28A) inside. Figure 28B shows the inserter device 250 in the deployment stage. The actuator 252 remains in the upper position, holding the drainage device within the needle 253, and the actuator is translated distally by the user to deploy the needle 253 distally (for example, to facilitate insertion of the needle 253 into the anterior chamber or another ocular compartment). Figure 28C shows the inserter device 250 in the engagement stage. At this stage, the button actuator 252 is pressed, releasing the drainage device 100 from the needle. For example, the tensioner and / or tissue grip can be engaged by pressing a button. Figure 28D shows the inserter device 250 in the retraction phase. At this phase, the user can retract the needle 253 from around the drainage device 100 by translating the sliding button actuator 252 proximal. The actuator 252 can be easily released from the implantation site by translating it proximal while it is in the pressed-down position.

[0077] According to several embodiments, the inserter device 250 may include a two-arm manipulator, for example, as shown in Figures 29A-29C. The two-arm manipulator may be operable by one or more actuators (not shown in Figures 29A-29C) so that portions of the drainage device 100 can be inserted into different compartments of the eye through a single incision 202. For example, the two-arm manipulator may facilitate an implantation procedure similar to that shown in Figures 24A-24D, where the first arm 207 facilitates the insertion of the distal end of the drainage device 100 into the anterior chamber, and the second arm 208 facilitates the insertion of the proximal end of the drainage device 100 into the space between the conjunctiva and the sclera, such as the subtenon's space, from different angles.

[0078] Figures 29A–29C show inserter devices 250 implemented with a two-arm manipulator in various operating stages. For example, as shown in Figure 29A, the two-arm inserter device 250 can be inserted into a single incision 202 of the eye 101, such as a conjunctival incision, to facilitate an extraocular approach. As shown in Figure 29B, the first arm 207 can engage a portion of the drainage device 100, such as the distal portion, and manipulate the drainage device 100 through the incision to insert that portion of the drainage device 100 into the anterior chamber. In some embodiments, an actuator (not shown in Figure 29B) can be operated to manipulate the first arm 207 to insert the portion of the drainage device 100 into the anterior chamber, and / or to release the portion of the drainage device 100 when it is in the desired position. As shown in Figure 29C, the second arm 208 can engage with another portion of the drainage device 100, such as the proximal portion. The user can pivot the inserter device 250 to approach the subtenon's capsule or other space from different angles through the same incision 202. In some embodiments, an actuator (not shown in Figure 29C), which may be the same as or separate from the actuator operating the first arm 207, can operate the second arm 208 to move the other part of the drainage device into the subtenon's capsule, and / or to release the other part of the drainage device 100 when it is in the desired position. One or more actuators may be configured to operate the first arm and the second arm independently. The arrows in Figure 29C indicate the direction of advancement of the second arm 208, which may be substantially transverse or tangential to the scleral or conjunctival surface.

[0079] Figures 30A and 30B are perspective and cutaway views of the inserter device 250a. For example, as shown in Figures 30A and 30B, the inserter device 250a may include a handle 254a and a needle 253 disposed on or off the nose 257a (e.g., distal end) of the handle 254a. A rack and pinion mechanism 215a may be coupled to the needle 253 and disposed within the handle 254a. The rack and pinion mechanism 215a may be fixedly attached to the needle 253 directly or indirectly, for example, so that the needle 253 moves together with the rack and pinion mechanism 215a. The rack and pinion mechanism 215a may also include a toothed rack 216a coupled to the needle 253 and configured to be coupled to or engaged with a gear 217a. An actuator 252a (e.g., a sliding button) disposed on the handle 254a can be coupled to or engaged with a gear 217a. When the actuator 252a is pushed forward (e.g., toward the needle 253), the actuator teeth 255a engage with the gear 217a, causing the gear to rotate in a first direction (e.g., counterclockwise). Thus, the gear 217a can apply a proximal force to the rack and pinion mechanism 215a, thereby causing the needle 253 to retract together with the rack and pinion mechanism 215a. The actuator 252a may also include a gear locking member 259a that prevents the gear 217a from rotating, thereby preventing the needle 253 from retracting while the needle 253 is inserted into the eye 101.

[0080] During operation, when the drainage devices 100, 100a, 100b, and 100c are properly positioned within the sclera 113, a user (e.g., an ophthalmic surgeon, a robotic arm) can insert the needle 253 into the eye 101 by grasping the handle 254a and pushing the inserter device 250a to move the needle 253 to the appropriate position within the eye 101. For example, the needle 253 may be pushed into the eye 101 until the nose 257a reaches or abuts the surface of the eye 101, thereby acting as a natural stopping point and keeping the eye 101 in place while the needle 253 is retracted. As shown in Figure 30C, the nose 257a may include a gripping member 267 (e.g., a pattern, material, or projection) that further stabilizes the inserter device 250a against the eye 101. For example, the gripping member 267 may be configured as teeth or ribs as shown in Figure 30C. Next, a forward force is applied to the actuator 252a to move it forward, thereby disengaging the gear locking member 259a from the gear 217a, engaging the rack and pinion mechanism 215a, and retracting the needle 253. By retracting the needle 253, the drainage devices 100, 100a, 100b, and 100c are positioned and remain within the sclera 113, after which the inserter device 250a can be pulled back to remove the needle 253 from the eye 101. The nose 257a may have an outer profile having a specific shape, such as a convex profile (e.g., a conical shape as shown in Figure 30C), a linear profile (e.g., a cylindrical shape), or a concave profile (e.g., a funnel shape). The distal surface of the nose 257a may be linear, convex, or concave as shown in Figure 30C. For example, a concave profile and / or a concave distal surface may be used to conform the nose 257a to or synchronize with the surface of the eye 101.

[0081] Figures 31A and 31B are perspective and cutaway views of the inserter device 250b. For example, as shown in Figures 31A and 31B, the inserter device 250b may include a handle 254b and a needle 253 disposed on or off the nose 257b (e.g., distal end) of the handle 254b. A shuttle mechanism 215b may be coupled to the needle 253 and disposed within the handle 254b. The shuttle mechanism 215b may be fixedly attached to the needle 253 directly or indirectly so that the needle 253 moves together with the shuttle mechanism 215b. The shuttle mechanism 215b may include a roller 216b that is movably coupled to or engaged with the tilting mechanism 258b of the handle 254b. The handle 254b may include a handle actuator 252b, which may be a movable section of the handle 254b arranged in a bivalve configuration, as shown in Figure 31A. As the handle actuators 252b are moved toward each other (e.g., crushed), the roller 216b moves backward (e.g., away from the nose 257b) along the tilting mechanism 258b of the handle 254b. Thus, the movement of the roller 216b allows a proximal force to be applied to the shuttle mechanism 215b, thereby causing the needle 253 to retract together with the shuttle mechanism 215b. A spring 259b can be disposed within the handle 254b and configured to bias the shuttle mechanism 215b and therefore the needle 253 in the forward position, thereby preventing or hindering the needle 253 from retracting while inserting the needle 253 into the eye 101.

[0082] The handle actuator 252b may be formed of a biasing material (e.g., a resistant and / or high-rigidity material) configured at least in part to bias the handle actuator 252b outward away from the handle 254b in order to activate the inserter device 250b during use (e.g., when retracting the needle 253 from the eye 101) and to smooth the crushing motion necessary to improve the control of the inserter device 250b. As shown in Figure 31C, the inserter device 250b may also include a biasing member 260b (e.g., a spring) configured to bias the handle actuator 252b outward away from the handle 254b. The biasing member 260b may be any type of biasing assembly, such as a leaf spring, compression spring, or compressible material. The outward biasing force may be provided by a combination of the biasing material and the biasing member 260b.

[0083] During operation, when the drainage devices 100, 100a, 100b, and 100c are properly positioned within the sclera 113, a user (e.g., an ophthalmic surgeon, a robotic arm) can insert the needle 253 into the eye 101 by grasping the handle 254a and pushing the inserter device 250b to move the needle 253 to the appropriate position within the eye 101. For example, the needle 253 may be pushed into the eye 101 until the nose 257b reaches or abuts the surface of the eye 101, thereby acting as a natural stopping point and keeping the eye 101 in place while the needle 253 is retracted. Similar to the nose 257a, the nose 257b may include a gripping member 267 (e.g., a pattern, material, or projection) that further stabilizes the inserter device 250b against the eye 101. Furthermore, similar to nose 257a, nose 257b may have an outer profile having a specific shape, such as a convex profile (e.g., a conical shape as shown in Figure 31B), a linear profile (e.g., a cylindrical shape), or a concave profile (e.g., a funnel shape). The distal end of nose 257b may be linear, convex, or concave as shown in Figure 31B. For example, a concave profile and / or a concave distal end may cause nose 257b to conform to or synchronize with the surface of eye 101. The crushing force then acts on handle actuator 252b to engage shuttle mechanism 215b, moving roller 216b along tilt mechanism 258b by overcoming the biasing force of spring 259b, and causing shuttle mechanism 215b and needle 253 to retract. By retracting the needle 253, the drainage devices 100, 100a, 100b, and 100c are positioned and remain within the sclera 113, after which the inserter device 250b can be pulled back to remove the needle 253 from the eye 101. The force compressing the handle actuator 252b is lateral (for example, perpendicular to the longitudinal axis of the handle 254b and the needle 253), so that displacement and undesirable movement of the drainage devices 100, 100a, 100b, and 100c can be minimized while the needle 253 is retracted.

[0084] Figures 15, 32, and 33 show various examples of needles 253 that can be implemented in the inserter device 250.

[0085] According to several embodiments, as shown in Figure 15, for example, the needle 253 may be realized having one or more slots 201 that can extend proximal and be configured to receive one or more corresponding fins 180 of the intraocular drainage device 100. The fins can facilitate the retention of the drainage device 100, such as retaining the tube 106 while deploying the drainage device 100 during the implantation procedure. For example, the proximal stopping surface 183 of each fin 180 may abut the distal side of the needle 253 of the inserter device 250 so that the drainage device remains housed within the needle while the needle 253 moves distally. The distal inclined surface 184 of each fin 180 may facilitate insertion through the ocular tissue while the needle 253 moves distally. The drainage device 100 can be drained from the inserter device 250 by retracting the needle 253, for example, while the proximal surface of the first retaining member 180 is in contact with patient tissue, holding the tube 106 in place within the eye. During the implantation procedure, the fins 180 may be positioned within the respective slots 201 included in the distal tip of the needle 253, thereby allowing the first retaining member 180 to contact the distal side of the needle 253 without the tube 106 protruding from the distal end of the needle 253. However, other implementations can be conceived in which the slots 201 are omitted.

[0086] According to some embodiments, for example as shown in Figure 15, the needle 253 may include an angled distal tip, the angled tip having an opening that serves as a release port for the drainage device 100.

[0087] According to several embodiments, the needle 253 can be realized having a solid nose distal tip (for example, a bullet shape as shown in Figure 32, or any other suitable shape). The release port 241 of the drainage device may be located on the side of the needle 253, proximal to the solid nose tip. The solid nose can help, for example, prevent tissue from clogging the needle 253 during insertion.

[0088] According to some embodiments, as shown in Figure 33, for example, the needle 253 may include an axial marking pattern extending axially along the needle 253 to indicate the insertion depth of the needle 253. For example, the marking pattern may include a series of 1-millimeter divisions, or any other suitable visual marking that varies axially and indicates the insertion depth of the needle 253. In another example, the needle 253 may include at least one measuring marker positioned at a specific distance (e.g., 3 mm) from the tip of the needle.

[0089] As shown in Figures 34A and 34B, the intraocular drainage device assembly 199 may include a plate 190 connected to the drainage devices 100, 100a, 100b, and 100c. The plate 190 may include a plate member 191 and a tube 192. An adapter 195 may provide an interface for inserting the drainage devices 100, 100a, 100b, and 100c into the tube 192. The adapter 195 may be integrally formed with the ends of the drainage device bodies 102, 102a, 102b, and 102c, or coupled to the ends, and its size and shape may be determined so as to be seal-engaged or coupled with the tube 192. For example, the adapter 195 may have a smooth outer surface (e.g., without patterning) to maximize engagement between the outer surface of the adapter 195 and the inner surface of the tube 192 in order to properly seal between the drainage devices 100, 100a, 100b, 100c and the plate 190 and / or tube 192. The adapter 195 may be of any desired length, such as 2 mm. As shown in Figure 34C, the adapter 195 may have a shoulder portion 193 between the drainage device bodies 102, 102a, 102b, 102c and the adapter 195 by having a size that gradually decreases (e.g., decreasing diameter) relative to the drainage device bodies 102, 102a, 102b, 102c. The shoulder portion 193 can provide a stopper to prevent over-insertion of the drainage devices 100, 100a, 100b, 100c into the tube 192.

[0090] The above description is provided to enable those skilled in the art to implement the various configurations described herein. While the subject art has been described in particular with reference to various drawings and configurations, it should be understood that these are illustrative and should not be construed as limiting the scope of the subject art.

[0091] Many other ways of realizing the subject art are possible. Various functions and elements described herein may be distinguished as different from those presented without departing from the scope of the subject art. Various modifications to these configurations will be readily apparent to those skilled in the art, and the general principles defined herein may be applied to other configurations. Thus, a number of changes and modifications to the subject art may be made by those skilled in the art without departing from the scope of the subject art.

[0092] The specific order or hierarchy of steps in the disclosed process is understood to be an example of an exemplary approach. The specific order or hierarchy of steps in the process may be rearranged based on design preferences. Some steps may be performed simultaneously. Any accompanying method claims present elements of various steps in a sample order and are not intended to limit the process to the specific order or hierarchy presented.

[0093] The terms "aspects" and similar phrases do not imply that such aspects are essential to the subject art or that such aspects apply to all components of the subject art. Disclosures relating to aspects may apply to all components, or one or more components. Aspects may provide one or more examples of the disclosure. The terms "aspects" and similar phrases may refer to one or more aspects, and vice versa. The terms "examples" and similar phrases do not imply that such examples are essential to the subject art or that such examples apply to all components of the subject art. Disclosures relating to examples may apply to all components, or one or more components. Examples may provide one or more examples of the disclosure. The terms "examples" and similar phrases may refer to one or more examples, and vice versa. The terms "components" and similar phrases do not imply that such components are essential to the subject art or that such components apply to all components of the subject art. The disclosures relating to the configuration may apply to all configurations, or to one or more configurations. A configuration may provide one or more examples of this disclosure. The terms “configuration” and similar phrases may refer to one or more configurations, and vice versa.

[0094] When used herein, the phrase “at least one” placed before a set of items, along with the terms “and” or “or” separating any of those items, modifies the list as a whole rather than each individual member of the list (i.e., each item). The phrase “at least one” does not require the selection of at least one of each enumerated item; rather, it allows the phrase to mean that at least one of any one of the items, and / or at least one of any combination of the items, and / or at least one of each of the items. For example, the phrases “at least one of A, B, and C” or “at least one of A, B, or C” refer to A only, B only, or C only, any combination of A, B, and C, and / or at least one of each of A, B, and C, respectively.

[0095] Terms such as “top,” “bottom,” “front,” and “rear” as used in this disclosure should be understood in reference to an arbitrary reference frame rather than a typical gravity reference frame. Accordingly, the top, bottom, front, and rear surfaces may extend upward, downward, diagonally, or horizontally in a gravity reference frame.

[0096] Furthermore, to the extent that terms such as “including” and “having” are used in this specification or in the claims, such terms shall be interpreted as in the same way that the term “equipped with” is interpreted when used as a transitional term in the claims.

[0097] The term “exemplary” is used herein to mean “serving as an example, case, or illustration.” Any example described herein as “exemplary” shall not necessarily be construed as being preferable or advantageous to other examples.

[0098] References to singular elements shall mean "one or more" and not "only one" unless specifically indicated otherwise. Masculine pronouns (e.g., he) include feminine and neuter pronouns (e.g., she and it), and vice versa. The term "several" refers to one or more. Underlined and / or italicized headings and subheadings are for convenience only and are not intended to limit the subject art, nor should they be referenced in conjunction with the interpretation of the description of the subject art. All structural and functional equivalents of elements of the various configurations described through this disclosure, whether now known or hereafter known to those skilled in the art, are expressly incorporated herein by reference and are encompassed by the subject art. Furthermore, all disclosures herein are made available to the public, whether or not such disclosures are expressly described in the above-mentioned specification.

[0099] While specific aspects and embodiments of the subject art have been described, these are presented merely as examples and are not intended to limit the scope of the subject art. In fact, the novel methods and systems described herein may be embodied in various other forms without departing from their spirit. The appended claims and their equivalents shall encompass such forms or modifications as being within the scope and spirit of the subject art.

Claims

1. The handlebars and A needle is disposed at the distal end of the handle and configured to hold an intraocular drainage device, An inserter device for ophthalmic implantation, comprising: a first plunger coupled to the needle and disposed within the handle, the first plunger being disposed distal to a first vacuum chamber within the handle and configured to retract the needle based on a proximal force applied by the first vacuum chamber.

2. The inserter device according to claim 1, further comprising a trigger button disposed on the handle and coupled to the first plunger, wherein when activated, the trigger button releases the first plunger, so that the proximal force applied by the first vacuum chamber retracts the first plunger, thereby retracting the needle.

3. The inserter device according to claim 1, further comprising a charge compartment disposed at the proximal end of the handle, which can be retracted relative to the handle to create a vacuum in the first vacuum chamber.

4. The inserter device according to claim 3, further comprising a finger loop disposed in the charging compartment.

5. A channel disposed on the proximal side of the first plunger, A second plunger is disposed within the channel, The inserter device according to claim 1, further comprising a second vacuum chamber disposed proximal to the second plunger.

6. The inserter device according to claim 5, further comprising a charge compartment disposed at the proximal end of the handle, which can be retracted relative to the handle to expand the second vacuum chamber and create a vacuum in the second vacuum chamber, wherein the vacuum in the second vacuum chamber is configured to apply a proximal force to the second plunger, causing the second plunger to translate proximal in the channel, and the proximal translation of the second plunger in the channel is configured to create a vacuum in the first vacuum chamber.

7. The inserter device according to claim 6, further comprising a valve disposed between the first vacuum chamber and the second vacuum chamber, wherein the charge compartment is capable of advancing distally with respect to the handle, and the valve is capable of releasing pressure while the charge compartment is advancing distally.

8. The inserter device according to claim 7, further comprising a safety device coupled to a trigger button, wherein the distal advance of the charge compartment is configured to release the safety device and allow the trigger button to be pressed.

9. The inserter device according to claim 1, further comprising: a slidable and pressable button disposed on the handle, wherein the sliding of the button is configured to translate the needle relative to the handle, and the pressing of the button is configured to release the intraocular drainage device from the needle.

10. The inserter device according to claim 9, wherein the proximal sliding of the button is configured to retract the needle in a proximal direction relative to the handle.

11. The inserter device according to claim 9, wherein the distal sliding of the button is configured to extend the needle distally relative to the handle.

12. A first arm configured to engage with the distal portion of the intraocular drainage device, The inserter device according to claim 1, further comprising: a second arm configured to engage with the proximal portion of the intraocular drainage device.

13. The inserter device according to claim 12, further comprising one or more actuators disposed on the handle and configured to independently operate the first arm and the second arm.

14. The inserter device according to any one of claims 1 to 13, wherein the needle comprises one or more slots extending proximal from the distal end of the needle, and the one or more slots are configured to receive one or more fins of the intraocular drainage device.

15. The inserter device according to any one of claims 1 to 13, wherein the distal end of the needle is provided with a solid nose, and an outlet port for the intraocular drainage device is disposed on the side of the needle proximal to the solid nose.

16. The inserter device according to any one of claims 1 to 13, wherein the needle is provided with an axial marking pattern indicating the insertion depth of the needle.

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