Glaucoma device inserter

Abstract

An insertion device is provided for use with a glaucoma drainage device including a tube having a proximal end, a distal end, and a lumen extending from the proximal end to the distal end. The insertion device includes an elongate member having a distal end defining a stop surface and a stylus extending beyond the distal end of the elongate member. The stylus is sized and configured to be received within the lumen of the glaucoma drainage device with the stop surface coupling to the glaucoma drainage device to limit proximal movement of the glaucoma drainage device. The stylus has a first length extending beyond the stop surface that is shorter than a second length of the portion of the lumen of the glaucoma drainage device that extends beyond the stop surface. Systems and methods are described and claimed.

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Provisional Patent Application No. 62 / 811,045, filed February 27, 2019, the entire contents of which are incorporated herein by reference. [Background technology]

[0002] InFocus, Inc. of Miami, Florida, has issued patents for glaucoma drainage implants (GDIs), such as patents 7,431,709, 7,594,899, 7,837,644, and 9,101,444, which are incorporated herein by reference. A typical GDI is shown in FIG. 1 and includes an elongated tubular body or tube 1 having a distal end 2 and a proximal end 3. One or more protrusions or fins 4 extend radially from the outer surface of the tube 1 at an intermediate location between the distal end 2 and the proximal end 3. When the GDI is implanted in the eye, the fins 4 can help prevent migration of the tube 1 into the eye. The tube 1 also includes a beveled surface 6 on the distal end 2. The tube 1 has an internal lumen 5 extending from the distal end 2 to the proximal end 3. The length of the lumen 5 is labeled L2 in FIG. 1. When the GDI is implanted in the eye, lumen 5 provides a flow path for fluid evacuation from the interior of the eye (eg, aqueous humor evacuation from the anterior chamber).

[0003] FIG. 2 shows an example of implantation or placement of a GDI within the eye. In this case, the distal end 2' is within the anterior chamber of the eye, and the tube 1' extends through the sclera 10 below the limbus. The proximal end 3' rests in the anatomical plane between the conjunctiva / Tenon's space and the sclera. Fluid (e.g., aqueous humor) from the anterior chamber flows through the lumen 5 of the GDI and drains into the subconjunctival / Tenon's space, forming a small bleb called a bleb. A protrusion or fin 4' is positioned posterior to the limbus and embedded in a small pocket 11 cut into the sclera with a scalpel or triangular knife. The GDI is typically placed in this position by creating a needle tract (or tissue passage) through the scleral pocket 11 and below the limbus into the anterior chamber. The GDI's tube G is grasped with forceps and inserted into this needle tract.

[0004] The GDI (particularly tube 1 and, optionally, fins 4 of the GDI) is typically made from a soft, flexible material such as poly(styrene-block-isobutylene-block-styrene) (SIBS) with a Shore hardness of less than 60A. In embodiments, the GDI is made from SIBS with a Shore hardness in the range of 30A to 50A, preferably 35A to 45A, and optionally 40A. In embodiments, the diameter of lumen 5 can be in the range of 0.04 mm to 0.1 mm, more preferably 60 μm to 80 μm, and even 70 μm. In embodiments, the outer diameter of tube 1 can be in the range of 0.2 mm to 0.8 mm, and even 0.35 mm. In these embodiments, the soft material and size of tube 1 on either side of fin 4 make it very prone to sagging, making it difficult to push through the needle tract below the limbus and into the anterior chamber.

[0005] Implantation of the device is traditionally accomplished by using forceps to hold the GDI near its proximal tip and gradually moving it through the pocket and needle tract into the anterior chamber. A problem with forceps is that the GDI must be held very carefully to avoid accidentally crushing the lumen, which can take tens of minutes to re-open due to its elasticity. Additionally, GDIs are very small and easily dropped. Furthermore, surgeons must lift their eyes from the operating microscope to retrieve the GDI from the operating room nurse, which is not optimal. Finally, GDIs do not always pass through the needle tract due to needle tract obstruction by fiber strands and the like. In short, implanting a GDI with forceps is awkward and suboptimal. There is a need for a faster and more reliable method for handling and implanting a GDI. Summary of the Invention

[0006] The present disclosure describes an inserter used to support a soft and flexible GDI during packaging, sterilization, and shipping and to facilitate implantation of the GDI into the eye. It is contemplated that the GDI and inserter may be packaged as a glaucoma system or kit, with the GDI supported by the inserter's stylus as described herein. [Brief explanation of the drawings]

[0007] [Figure 1] FIG. 1 is a schematic cross-sectional view of a prior art GDI. [Figure 2] FIG. 2 is a diagram illustrating an example of implantation or placement of the GDI of FIG. 1 within the eye. [Figure 3] FIG. 3 is a diagram illustrating the anatomical structures or anatomical parts of the eye. [Figure 4] FIG. 4 illustrates a needle forming a needle tract (or tissue passage) below the limbus into the anterior chamber of the eye. [Figure 5] FIG. 5 is a diagram illustrating the needle path formed by the needle of FIG. [Figure 6] FIG. 6 shows the insertion of a stylus into the needle path of FIG. [Figure 7A] FIG. 7A shows an inserter with a stylus for supporting and carrying the GDI of FIG. [Figure 7B] FIG. 7B illustrates an inserter having a stylus that supports and carries the GDI of FIG. 1, the stylus being sized and configured to extend to the distal end of the GDI. [Figure 7C] FIG. 7C illustrates an inserter having a stylus that supports and carries the GDI of FIG. 1, the stylus being sized and configured to extend well beyond the distal end of the GDI. [Figure 7D] FIG. 7D illustrates an inserter having a stylus that supports and carries the GDI of FIG. 1, the stylus being sized and configured such that the distal end of the stylus is proximally offset by a distance d relative to the distal end of the GDI. [Figure 8]FIG. 8 shows the inserter of FIG. 7D being used to insert and pass the GDI of FIG. 1, carried on the stylus of the inserter, into the needle path of FIG. 5. [Figure 9] FIG. 9 shows an alternative embodiment of an inserter similar to that of FIG. 7D. [Figure 10] FIG. 10 shows an alternative embodiment of an inserter similar to that of FIG. 7D. [Figure 11A] FIG. 11A shows an alternative embodiment of an inserter similar to that of FIG. 7D. [Figure 11B] FIG. 11B shows an alternative embodiment of an inserter similar to that of FIG. 7D. [Figure 12A] FIG. 12A shows an alternative embodiment of an inserter similar to that of FIG. 7D. [Figure 12B] FIG. 12B shows an alternative embodiment of an inserter similar to that of FIG. 7D. DETAILED DESCRIPTION OF THE INVENTION

[0008] In this disclosure, the term "proximal" means closer to the surgeon implanting the device, and "distal" means further from the surgeon implanting the device.

[0009] This disclosure describes an inserter that allows a soft and flexible GDI to be inserted into a needle tract (or tissue passage) leading to the anterior chamber of the eye, with the distal end 2 of the GDI within the anterior chamber. The inserter includes a stylus disposed within and received by the lumen 5 of the GDI. The stylus functions to support and carry the GDI as it is inserted into and through the needle tract. For purposes of this disclosure, the stylus may be a wire, guidewire, stylet, stiffener, or equivalent, and for simplicity will be referred to simply as a stylus. Furthermore, to fit within the lumen 5 of the GDI, the maximum outer diameter of the stylus is smaller than the inner diameter (or lumen) of the GDI, which in this embodiment is 60 μm to 80 μm. Examples of materials from which the stylus can be constructed include stainless steel, cobalt-chromium-nickel (Elgiloy), nitinol, tungsten, and equivalents. In an embodiment, the material comprising the stylus is relatively rigid (compared to the flexible material of the GDI tubing), non-corrosive and biocompatible.

[0010] Figure 3 is similar to Figure 2 except that the conjunctiva, Tenon's capsule, bleb, and GDI have been omitted for ease of illustration. To insert the GDI below the limbus with its distal end within the anterior chamber of the eye, a needle 40 is used to create a needle tract (or tissue passage) below the limbus into the anterior chamber, as shown in Figure 4. Prior to needle tract creation, a small pocket is usually created in the sclera using a scalpel or triangular knife, which will ultimately accommodate the GDI fin 4. In this type of surgery, the patient is typically instructed to look down or up to expose more sclera to facilitate needle tract creation and device implantation. Sometimes, it is also necessary to place traction sutures (not shown) through a partial thickness of the cornea so that the surgeon can rotate the eye by pulling on the traction sutures to facilitate scleral exposure. When the tissue below the limbus is compressed in these ways and the needle is forced through it, it is common for the needle path so formed to be curved rather than straight when the needle 40 is removed and the eye is allowed to relax.

[0011] FIG. 5 shows a needle path 50 formed as such a curved path, which, as will be explained below, makes it difficult to facilitate placement of a GDI using a conventional stylus.

[0012] FIG. 6 shows a stylus 60 having a distal tip 61. The stylus 60 is sufficiently thin to slidably fit within the lumen 5 of the GDI (see FIG. 1). The maximum outer diameter of the stylus 60 is approximately 10% to 30% smaller than the diameter of the lumen 5 of the GDI. For example, if the diameter of the lumen 5 of the GDI is within the range of 60 μm to 80 μm, the maximum outer diameter of the stylus 60 is within the range of 42 μm to 72 μm. The stylus may be a straight wire or may be tapered along its length. Note that a thin stylus of this size has a sharp distal tip, and if made sufficiently stiff to allow for pushing, the stylus 60 will not follow the needle tract 50 but will instead penetrate tissue adjacent to the needle tract at the bend, as shown by the distal section 61 of the stylus 60 protruding into the sclera.

[0013] 7A shows an inserter 70 that includes a handle 71, a stylus 72 extending from the distal end of the handle 71, an optional grip 73, and an optional orientation marker 74. The orientation marker 74 aligns with the plane of the bevel 6 at the distal end 2 of the GDI and indicates to the surgeon where the plane of the bevel 6 is, as the bevel should face the cornea. For example, before inserting the GDI into the tissue tract, the surgeon is instructed to position the GDI on the stylus 72 so that the bevel 6 is flush with the orientation marker 74. In this example, the stylus 72 is rigidly fixed to the handle 71. In embodiments, the GDI remains positioned on the stylus 72 due to friction between the intraluminal wall of the GDI and the stylus 72. Such friction may also limit or reduce rotational movement of the GDI about the stylus 72.

[0014] 7B shows an inserter 70-1 with a stylus 72-1 configured to match the length of the lumen 5 of the GDI tube 1. In this configuration, the distal end 75 of the handle 71 provides a stop surface that couples with the proximal end 3 of the GDI tube 1 when the stylus 72-1 is received within the lumen 5 of the GDI tube 1. With the proximal end 3 of the GDI tube 1 abutting the stop surface provided by the distal end 75 of the handle 71, the stylus 72-1 extends within the lumen 5 of the GDI tube 1 approximately to the distal end 2 of the GDI bevel. This configuration of the stylus 72-1 cannot be used to effectively insert a GDI into a needle tract because the GDI is very soft and will corrugate in the region of its distal end 2 as it enters the needle tract 50, exposing the stylus 72-1 to stick to tissue and not follow the needle tract 50 as described above for FIG. 6.

[0015] 7C shows an inserter 70-2 having a stylus 72-2 configured such that the length of the stylus 72-2 is longer than the length of the lumen 5 of the GDI tube 1. In this configuration, the distal end 75 of the handle 71 provides a stop surface that couples with the proximal end 3 of the GDI tube 1 when the stylus 72-2 is received within the lumen 5 of the GDI tube 1. With the proximal end 3 of the GDI tube 1 abutting the stop surface provided by the distal end 75 of the handle 71, the stylus 72-2 extends within the lumen 5 of the GDI tube 1 sufficiently beyond the distal end 2 of the GDI bevel, thereby protruding from the distal end 2 of the GDI. This configuration of stylus 72-2 cannot be used to effectively insert a GDI into the needle tract because the distal portion of stylus 72-2 that extends beyond the distal end 2 of the GDI bevel adheres to the tissue and does not follow the needle tract 50, as described above for FIG. 6.

[0016] 7D shows an inserter 70-3 having a stylus 72-3 configured such that the length L1 of the stylus 72-3 is shorter than the length L2 of the lumen 5 of the GDI tube 1. In this configuration, the distal end 75 of the handle 71 provides a stop surface that couples with the proximal end 3 of the GDI tube 1 (when the stylus 72-3 is received within the lumen 5 of the GDI tube 1) and functions to limit proximal movement of the GDI. With the proximal end 3 of the tube 1 abutting the stop surface provided by the distal end 75 of the handle 71, the length L1 of the stylus 72-3 extends within the lumen 5 of the GDI tube 1 to approximately 1 mm proximal of the distal end 2 of the GDI. This configuration of stylus 72-3 can be used to effectively insert the GDI into the needle tract because the distal portion of the GDI extending beyond the distal end of stylus 72-3 can follow the needle tract because the soft tube 1 of the GDI cannot penetrate tissue but rather bends to follow the needle tract. This finding was not at all obvious.

[0017] Note that the stylus 72-3 is sufficiently rigid to ensure rigidity of the GDI during insertion into and passage through the needle tract. The stylus 72-3 is also short enough so as not to restrict the GDI from following the contours of the needle tract. This procedure is illustrated in FIG. 8 , where the distal tip 80 of the GDI tube 1 and the stylus 72-3 of the inserter 70-3 provide the rigidity to allow continued insertion of the GDI through the needle tract. Once the GDI is in place, as shown in FIG. 2 , the stylus 72-3 can simply be withdrawn or retracted from the lumen 5 of the GDI, leaving the GDI in the needle tract. This procedure is facilitated by holding the GDI in place with forceps as the stylus 72-3 of the inserter 70-3 is withdrawn or retracted from the lumen 5 of the GDI tube 1.

[0018] Note that the length L1 of the stylus 72-3 is configured to be shorter than the length L1 of the entire lumen 5 of the GDI tube 1 extending from the stop surface defined by the distal end 75 of the handle 71. In this configuration, when the proximal end 3 of the GDI tube 1 abuts against the stop surface provided by the distal end 75 of the handle 1, the distal end of the stylus 72-3 is displaced from the distal tip of the GDI by a displacement or distance d, as shown in FIG. 7D. As shown in FIG. 7D, the displacement d is determined by the difference between the total length L2 of the lumen 5 of the GDI tube 1 and the shorter length L1 of the stylus 72-3. In embodiments, the displacement d (i.e., the difference between the tube lumen L2 and the stylus 72-3 L1) is in the range of 0.5 mm to 3 mm, preferably 1 mm to 2 mm. A lubricant may be applied to the GDI lumen 5 to facilitate sliding of the stylus within the GDI lumen 5. Exemplary lubricants include, but are not limited to, glycerin, hyaluronic acid, and methylcellulose.

[0019] 9-12B show an alternative embodiment of an inserter similar to the inserter of FIG. 7D.

[0020] Figure 9 shows an embodiment of an inserter 70-4 similar to Figure 7D with a GDI and a removable, disposable cap 90 placed over the distal portion of the handle 71 of the inserter 70-4. The cap 90 is designed with cutouts or loose crossovers to allow for ethylene oxide sterilization and is removed for use.

[0021] FIG. 10 shows an embodiment of an inserter 70-5 similar to FIG. 7D with a rigid overtube 100 rigidly attached to the handle 71 of the inserter 70-5, which can provide additional support for the inserter's stylus to aid in insertion. The overtube 100 is made from metal hypodermic tubing and plastics made from polyester, Delrin, nylon, Teflon, polyimide, polysulfone, and equivalents. It is also envisioned that the overtube 100 receives and surrounds the proximal portion of the GDI and presses against the fins 4 of the GDI during insertion and passage of the GDI into and through the needle tract as described herein, facilitating insertion of the GDI. Note that while the distal end of the tube 100 presses against the fins 4 during insertion and passage of the GDI into and through the needle tract, the stylus provides rigidity to the GDI to reduce or limit the possibility of the distal end of the stylus penetrating the wall of the GDI tube during insertion.

[0022] 11A and 11B show an embodiment of an inserter 70-6 similar to that of FIG. 7D with a retractable stylus 72-6. The stylus 72-6 is rigidly attached to a thumb slide 110. With the GDI in place (FIG. 11A), the user can retract the thumb slide 110 proximally (relative to the handle 71), as shown in FIG. 11B, and the stylus 72-6 is retracted so that the stylus 72-6 moves proximally relative to the GDI, and the GDI is removed from the lumen 5 of the GDI tube 1 with the GDI in the position shown. A locking feature (not shown) may be incorporated into the inserter 70-6 shown in FIGS. 11A and 11B to lock the slide 110 in its inactivated (non-retracted) position as shown in FIG. 11A. The locking feature is configured to prevent movement of the slide 110 during transport of the inserter 70-6. During use of the inserter 70-6, the locking member can be removed or otherwise displaced to unlock the slide 110. In embodiments, the locking member can take the form of a pin configured to selectively transversely engage the slide 110 and a wall of the handle 71 to lock the slide 110. Such pins are selectively removed or displaced from one or both of the slide 110 and the wall of the handle 71 to unlock the slide 110 and allow the user to move the slide 110 relative to the handle 71. Also, in embodiments, the locking member is a piece of material that fits into the path of the slide 110 (similar to a piece of wood used to prevent a sliding door from opening) to prevent the slide 110 from retracting or otherwise moving relative to the handle 71. During use of the inserter 70-6, such piece of material is removed from the path, allowing the user to move the slide 110 within the path.

[0023] 12A and 12B show an embodiment of an inserter 70-7 similar to FIGS. 7D, 10, and 11 with a retractable stylus 72-7 that is spring-biased to move the stylus 72-7 proximally relative to the GDI and can be removed from the lumen 5 of the GDI tube 1 by simple spring actuation with the GDI in place. In this embodiment, the handle 71 has an internal chamber 120 at its proximal end that houses a spring 121. The spring 121 is a wishbone actuator 123 that can slide or move proximally within the internal chamber 120 under user control. The actuator 123 has a proximal base 125 and opposing arms 127A, 127B. The proximal end of the stylus 72-7 is rigidly anchored or captured by the actuator base 125.

[0024] In the spring-loaded configuration of the inserter 70-7 shown in FIG. 12A , the arms 127A, 127B of the actuator 123 extend distally from the base 125 through corresponding slots 129A, 129B in the handle 71 to the exterior space. The arms 127A, 127B abut the proximal ends of the corresponding slots 129A, 129B, holding the actuator 123 in place when the spring 121 is compressed. In the spring-loaded configuration of the inserter 70-7, the distal portion of the stylus 72-7, which extends through the overtube 100 and beyond the distal end 101 of the overtube 100, can support the GDI. Specifically, the distal portion of the stylus 72-7 is inserted into the lumen 5 of the GDI tube 1 such that the distal portion of the stylus 72-7 extends within the lumen 5 of the GDI tube 1, as shown. In this configuration, the distal end 101 of the overtube 100 provides a stop surface that couples with the fins 4 of the GDI (when the stylus 72-7 is received within the lumen 5 of the tube 1 of the GDI) and functions to limit proximal movement of the GDI.

[0025] If the inserter 70-7 is in a spring-loaded configuration, the user / operator can apply manual force through hand / finger pressure to push the arms 127A, 127B of the actuator 123 radially inward (indicated by the arrows labeled A), releasing the arms 127A, 127B from engagement with the proximal ends of the corresponding slots 129A, 129B. Such action releases the actuator 123 and allows the compressed spring 123 to expand, which causes the spring force of the compressed spring 123 to move or slide the actuator 123 proximally within the chamber 123, as shown in the spring-released configuration of the inserter 70-7 shown in FIG. Note that with actuator 123 connected to stylus 72-7, proximal movement of actuator 123 causes stylus 72-7 to move proximally or retract such that the distal portion of stylus 72-7 is removed from lumen 5 of GDI tube 1, as is evident from FIG. 12B.

[0026] 12A, the length L3 of the stylus 72-7 extending beyond the stop surface provided by the distal tip 101 of the overtube 100 is configured to be less than the length L4 of the portion of the lumen 5 of the GDI tube 1 that extends beyond the stop surface provided by the distal tip 101 of the overtube 100. With the inserter 70-7 in a spring-loaded configuration, and the distal portion of the stylus 72-7 inserted into the lumen 5 of the GDI tube 1 such that the distal portion of the stylus 72-7 extends within the lumen 5 of the GDI tube 1 as shown, the distal portion of the stylus 72-7 is displaced or displaced a distance d from the distal tip of the GDI, as shown in FIG. As shown in FIG. 12A, the displacement d is determined by the difference between the length L4 of the portion of the lumen 5 of the GDI tube 1 that extends beyond the stop surface provided by the distal tip 101 of the overtube 100 and the shorter length L3 of the stylus 72-7 that extends beyond the stop surface provided by the distal tip 101 of the overtube 100. In embodiments, the displacement d (i.e., the difference between L4 of the tube lumen and L3 of the stylus 72-7) is in the range of 0.5 mm to 3 mm, preferably 1 mm to 2 mm. A lubricant can be applied to the lumen 5 of the GDI to facilitate sliding of the stylus within the lumen 5 of the GDI. Exemplary lubricants include, but are not limited to, glycerin, hyaluronic acid, and methylcellulose.

[0027] In an embodiment, the inserter stylus is formed from drawn wire, with the amount of drawdown determining its hardness. The wire needs to be sufficiently stiff, but not too brittle to avoid failure when bent slightly. Various manufacturing methods can be used to manufacture and assemble the inserter handle and stylus assembly. For example, the handle is manufactured by injection molding, with a hole at the distal end sized to accommodate the stylus. The stylus is cut to length and electropolished. The cut length is dipped in UV-curable adhesive, inserted into the handle hole, and then irradiated with UV light until cured. A GDI is then installed on the stylus and oriented so that the bevel 6 of the GDI is aligned with the orientation marker on the handle.

[0028] In embodiments, the inserter with stylus and GDI are packaged as a glaucoma system or kit with the GDI supported by the stylus of the inserter, where the stylus is disposed within and received by the lumen 5 of the tube 1 of the GDI, as shown in Figures 7D and 12A.

[0029] The inserter configuration and GDI as described herein are easily placed in a blister package, with or without a cap (90 in FIG. 9), and sterilized according to standard sterilization procedures, preferably with ethylene oxide. The fact that the stylus has a smaller diameter than the lumen of the GDI allows the ethylene oxide to penetrate the length of the lumen. Furthermore, the inserter configuration and GDI as described herein can be removed from the package and handed to a surgeon without the surgeon having to look up from the operating microscope. Orientation markings 74 on the inserter indicate which side is the bevel (6) side, and the surgeon can deploy the GDI at the desired implantation location by simply inserting the device into and through the needle tract, as described herein.

[0030] In the present embodiment, several embodiments of a glaucoma device inserter have been described and illustrated. Although specific embodiments have been described, it is not intended that the invention be limited thereto, and it is intended that the invention have the broadest scope permitted in the art, and that the specification be read in the same manner. Therefore, it will be understood by those skilled in the art that further modifications can be made to the provided invention without departing from the spirit and scope of the claims. The present disclosure encompasses the following aspects. (1) 1. An insertion device for use with a glaucoma drainage device, the insertion device comprising a tube having a proximal end, a distal end, and a lumen extending from the proximal end to the distal end, an elongated member having a distal end defining a stop surface; a stylus extending beyond the distal end of the elongated member; Equipped with an insertion device, wherein the stylus is sized and configured to be received within the lumen of the glaucoma drainage device with the stop surface coupling to the glaucoma drainage device to limit proximal movement of the glaucoma drainage device, and the stylus has a first length extending beyond the stop surface that is shorter than a second length of the portion of the lumen of the glaucoma drainage device tube that extends beyond the stop surface. (2) The insertion device according to (1) above, wherein the difference between the second length of the lumen of the tube of the glaucoma drainage device and the first length of the stylus is within a range of 0.5 mm to 3 mm. (3) The insertion device according to (1) above, wherein the difference between the second length of the lumen of the tube of the glaucoma drainage device and the first length of the stylus is within a range of 1 mm to 2 mm. (4) 11. The insertion device of claim 1, wherein at least a portion of the stylus is sized and configured to slide within the lumen of the glaucoma drainage device tube. (5) 10. The insertion device of claim 1, further comprising a lubricant that facilitates sliding movement of the stylus within the lumen of the glaucoma drainage device. (6) The insertion device according to (1) above, wherein the stylus has a maximum outer diameter that is 10% to 30% smaller than the diameter of the lumen of the tube of the glaucoma drainage device. (7) The insertion device according to (1) above, wherein the diameter of the lumen of the tube of the glaucoma drainage device is within the range of 60 mm to 80 mm, and the stylus has a maximum outer diameter within the range of 42 μm to 72 μm. (8) The insertion device of (1) above, wherein the stylus is made from a relatively hard and rigid material and the tube of the glaucoma drainage device is made from a relatively soft and flexible material. (9) 9. The insertion device of claim 8, wherein the material of the stylus is selected from the group consisting of stainless steel, cobalt chromium nickel compound (Elgiloy), nitinol, tungsten, and equivalents thereof. (10) The insertion device according to (8) above, wherein the material of the tube of the glaucoma drainage device is poly(styrene block isobutylene block styrene) (SIBS) with a Shore hardness of less than 60A. (11) The insertion device of (1) above, wherein the elongated member includes a directional marker that is aligned with a bevel on the distal end of the tube of the glaucoma drainage device. (12) The insertion device described in (1) above, wherein the stylus is retractable by operating the insertion device so that the stylus moves proximally relative to the glaucoma drainage device and removes the stylus from the lumen of the tube of the glaucoma drainage device. (13) The insertion device described in (1) above, wherein the stop surface is coupled to the proximal end of the glaucoma drainage device to limit proximal movement of the glaucoma drainage device, and the first length of the stylus is shorter than the overall length of the lumen of the tube of the glaucoma drainage device. (14) The insertion device of (1) above, wherein the elongated member includes an overtube configured to receive and surround a proximal portion of the glaucoma drainage device. (15) for use with the glaucoma drainage device, further comprising at least one protrusion extending radially from the glaucoma drainage device tube at an intermediate location between the proximal and distal ends of the glaucoma drainage device tube; The insertion device of claim 14, wherein the overtube of the insertion device provides a distal end defining the stop surface, which couples to at least one protrusion of the glaucoma drainage device to limit proximal movement of the glaucoma drainage device. (16) a glaucoma drainage device including a tube having a proximal end, a distal end, and a lumen extending from the proximal end to the distal end; an insertion device including an elongated member having a distal end defining a stop surface and a stylus extending beyond the distal end of the elongated member; 1. A glaucoma system comprising: 1. A glaucoma system, wherein the stylus is sized and configured to be received within the lumen of the glaucoma drainage device with the stop surface coupled to the glaucoma drainage device to limit proximal movement of the glaucoma drainage device, and the stylus has a first length extending beyond the stop surface that is shorter than a second length of a portion of the lumen of the glaucoma drainage device tube that extends beyond the stop surface. (17) The glaucoma system according to (16) above, wherein the difference between the second length of the lumen of the tube of the glaucoma drainage device and the first length of the stylus is within the range of 0.5 mm to 3 mm. (18) The glaucoma system according to (16) above, wherein the difference between the second length of the lumen of the tube of the glaucoma drainage device and the first length of the stylus is within the range of 1 mm to 2 mm. (19) 17. The glaucoma system of claim 16, wherein at least a portion of the stylus is sized and configured to slide within the lumen of the tube of the glaucoma drainage device. (20) The glaucoma system of claim 16, further comprising a lubricant that facilitates sliding movement of the stylus within the lumen of the glaucoma drainage device. (21) The glaucoma system according to (16) above, wherein the stylus has a maximum outer diameter that is 10% to 30% smaller than the diameter of the lumen of the tube of the glaucoma drainage device. (22) The glaucoma system according to (16) above, wherein the diameter of the lumen of the tube of the glaucoma drainage device is within the range of 60 mm to 80 mm, and the stylus has a maximum outer diameter within the range of 42 μm to 72 μm. (23) The glaucoma system of claim 16, wherein the stylus is made from a relatively hard and rigid material and the tube of the glaucoma drainage device is made from a relatively soft and flexible material. (24) 24. The glaucoma system of claim 23, wherein the material of the stylus is selected from the group consisting of stainless steel, cobalt chromium nickel compound (Elgiloy), nitinol, tungsten, and equivalents thereof. (25) The glaucoma system according to (23) above, wherein the material of the tube of the glaucoma drainage device is poly(styrene block isobutylene block styrene) (SIBS) having a Shore hardness of less than 60A. (26) The glaucoma system of claim 16, wherein the elongated member includes a directional marker that is aligned with a bevel on the distal end of the tube of the glaucoma drainage device. (27) The glaucoma system of claim 16, wherein the stylus is retractable by manipulating the insertion device to move the stylus proximally relative to the glaucoma drainage device and remove the stylus from the lumen of the tube of the glaucoma drainage device. (28) The glaucoma system of claim 16, wherein the stop surface is coupled to the proximal end of the glaucoma drainage device to limit proximal movement of the glaucoma drainage device, and the first length of the stylus is shorter than the overall length of the lumen of the tube of the glaucoma drainage device. (29) The glaucoma system of claim 16, wherein the elongated member of the insertion device includes an overtube configured to receive and surround a proximal portion of the glaucoma drainage device. (30) the glaucoma drainage device further comprising at least one protrusion extending radially from the glaucoma drainage device tube at a location intermediate between the proximal and distal ends of the glaucoma drainage device tube; The glaucoma system of claim 29, wherein the overtube provides a distal end defining the stop surface, the stop surface engaging at least one protrusion of the glaucoma drainage device to limit proximal movement of the glaucoma drainage device. (31) 1. A method of implanting a glaucoma drainage device in an eye, comprising: forming a tissue passageway below the limbus into the anterior chamber of the eye; inserting a glaucoma drainage device carried on a stylus of an insertion tool through the tissue passage so that a distal end of the glaucoma drainage device is positioned within the anterior chamber; retracting the stylus from the glaucoma drainage device while leaving the glaucoma drainage device in the tissue channel; A method comprising: (32) the glaucoma drainage device includes a tube having a proximal end, a distal end, and a lumen extending from the proximal end to the distal end; the insertion device includes an elongated member having a distal end defining a stop surface and a stylus extending beyond the distal end of the elongated member; 32. The method of claim 31, wherein the stylus is received within the lumen of the glaucoma drainage device with the stop surface coupled to the glaucoma drainage device to limit proximal movement of the glaucoma drainage device, and the stylus has a first length extending beyond the stop surface that is shorter than a second length of the portion of the lumen of the glaucoma drainage device tube that extends beyond the stop surface. (33) 33. The method of claim 32, further comprising forming a pocket in the sclera to accommodate a protrusion extending radially from the outer surface of the tube of the glaucoma drainage device at an intermediate location between the distal end of the glaucoma drainage device and the proximal end of the glaucoma drainage device. (34) 33. The method of claim 32, wherein retracting the stylus comprises actuating a sliding mechanism of the inserter configured to retract the stylus proximally against the stop surface.

Claims

1. 1. An insertion device for use with a glaucoma drainage device, the insertion device comprising a tube having a proximal end, a distal end, and a lumen extending from the proximal end to the distal end, an elongate member having a distal end defining a stop surface and including an overtube configured to receive and surround a proximal portion of the glaucoma drainage device; moreover, a stylus extending beyond the distal end of the elongate member; Equipped with the stylus is sized and configured to be received within the lumen of the glaucoma drainage device with the stop surface engaging the glaucoma drainage device to limit proximal movement of the glaucoma drainage device as the glaucoma drainage device is inserted through and passes through the needle tract, the stylus having a first length extending beyond the stop surface that is shorter than a second length of the portion of the lumen of the glaucoma drainage device tube that extends beyond the stop surface; the glaucoma drainage device further includes at least one protrusion extending radially from the glaucoma drainage device tube at a location intermediate between the proximal and distal ends of the glaucoma drainage device tube; the overtube of the insertion device has a distal end defining the stop surface; An insertion device, wherein the stop surface couples to the at least one protrusion of the glaucoma drainage device to limit proximal movement of the glaucoma drainage device.

2. An insertion device as described in claim 1, wherein the difference between the second length of the lumen of the tube of the glaucoma drainage device and the first length of the stylus is within the range of 0.5 mm to 3 mm.

3. 10. The insertion device of claim 1, wherein the difference between the second length of the lumen of the glaucoma drainage device tube and the first length of the stylus is in the range of 1 mm to 2 mm.

4. The insertion device of claim 1 , wherein at least a portion of the stylus is sized and configured to slide within a lumen of a tube of the glaucoma drainage device.

5. 10. The insertion device of claim 1, further comprising a lubricant that facilitates sliding movement of the stylus within the lumen of the glaucoma drainage device.

6. The insertion device of claim 1 , wherein the stylus has a maximum outer diameter that is 10% to 30% smaller than the diameter of the lumen of the glaucoma drainage device tube.

7. 10. The insertion device of claim 1, wherein the glaucoma drainage device tubing has a lumen diameter in the range of 60 μm to 80 μm, and the stylus has a maximum outer diameter in the range of 42 μm to 72 μm.

8. 10. The insertion device of claim 1, wherein the stylus is made from a relatively hard and rigid material and the glaucoma drainage device tube is made from a relatively soft and flexible material.

9. 9. The insertion device of claim 8, wherein the stylus material is selected from the group consisting of stainless steel, cobalt chromium nickel compound (Elgiloy), nitinol, tungsten, and equivalents thereof.

10. 10. The insert device of claim 8, wherein the material of the glaucoma drainage device tube is poly(styrene block isobutylene block styrene) (SIBS) with a Shore hardness of less than 60A.

11. An insertion device as described in claim 1, wherein the elongated member includes a directional marker that is aligned with a bevel on the distal end of the tube of the glaucoma drainage device.

12. 10. The insertion device of claim 1, wherein the stylus is retractable by manipulation of the insertion device to move the stylus proximally relative to the glaucoma drainage device and remove the stylus from the lumen of the glaucoma drainage device tube.

13. 2. The insertion device of claim 1, wherein the stop surface couples to a proximal end of the glaucoma drainage device to limit proximal movement of the glaucoma drainage device, and the first length of the stylus is less than the overall length of a lumen of a tube of the glaucoma drainage device.

14. A glaucoma system, comprising: a glaucoma drainage device including a tube having a proximal end, a distal end, and a lumen extending from the proximal end to the distal end; an insertion device including an elongate member having a distal end defining a stop surface and including an overtube, and a stylus extending beyond the distal end of the elongate member, the overtube configured to receive and surround a proximal portion of the glaucoma drainage device; the stylus is sized and configured to be received within the lumen of the glaucoma drainage device with the stop surface engaging the glaucoma drainage device to limit proximal movement of the glaucoma drainage device as the glaucoma drainage device is inserted through and passes through the needle tract, the stylus having a first length extending beyond the stop surface that is shorter than a second length of the portion of the lumen of the glaucoma drainage device tube that extends beyond the stop surface; the glaucoma drainage device further comprising at least one protrusion extending radially from the glaucoma drainage device tube at a location intermediate between the proximal and distal ends of the glaucoma drainage device tube; The glaucoma system, wherein the overtube presents a distal end defining the stop surface, the stop surface coupling to at least one protrusion of the glaucoma drainage device to limit proximal movement of the glaucoma drainage device.

15. A glaucoma system as described in claim 14, wherein the difference between the second length of the lumen of the tube of the glaucoma drainage device and the first length of the stylus is within the range of 0.5 mm to 3 mm.

16. 15. The glaucoma system of claim 14, wherein the difference between the second length of the lumen of the glaucoma drainage device tube and the first length of the stylus is in the range of 1 mm to 2 mm.

17. The glaucoma system of claim 14 , wherein at least a portion of the stylus is sized and configured to slide within a lumen of a tube of the glaucoma drainage device.

18. 15. The glaucoma system of claim 14, further comprising a lubricant that facilitates sliding movement of the stylus within the lumen of the glaucoma drainage device.

19. 15. The glaucoma system of claim 14, wherein the stylus has a maximum outer diameter that is 10% to 30% smaller than the diameter of the lumen of the glaucoma drainage device tube.

20. 15. The glaucoma system of claim 14, wherein the diameter of the lumen of the glaucoma drainage device tube is in the range of 60 μm to 80 μm, and the stylus has a maximum outer diameter in the range of 42 μm to 72 μm.

21. 15. The glaucoma system of claim 14, wherein the stylus is made from a relatively hard and rigid material and the glaucoma drainage device tube is made from a relatively soft and flexible material.

22. 22. The glaucoma system of claim 21, wherein the stylus material is selected from the group consisting of stainless steel, cobalt chromium nickel compound (Elgiloy), nitinol, tungsten, and equivalents thereof.

23. 22. The glaucoma system of claim 21, wherein the material of the glaucoma drainage device tubing is poly(styrene-block-isobutylene-block-styrene) (SIBS) with a Shore hardness of less than 60A.

24. A glaucoma system as described in claim 14, wherein the elongated member includes a directional marker aligned with a bevel on the distal end of the tube of the glaucoma drainage device.

25. 15. The glaucoma system of claim 14, wherein the stylus is retractable by manipulation of the insertion device to move the stylus proximally relative to the glaucoma drainage device and remove the stylus from the lumen of the glaucoma drainage device tube.

26. 15. The glaucoma system of claim 14, wherein the stop surface couples to a proximal end of the glaucoma drainage device to limit proximal movement of the glaucoma drainage device, and the first length of the stylus is less than the overall length of the lumen of the glaucoma drainage device tube.

27. The insertion device of claim 1 , wherein the stylus is spring biased to move proximally relative to the glaucoma drainage device.

28. one end of the spring is secured to a distal end of the interior chamber of the elongate member; the other end of the spring is fixed to the proximal base of a wishbone-shaped actuator in the internal chamber; a proximal end of the stylus fixed to the base; 28. The insertion device of claim 27, wherein the two arms of the actuator extend through two slots in the elongated member, respectively, to the exterior space.

29. 15. The glaucoma system of claim 14, wherein the stylus is spring biased to move proximally relative to the glaucoma drainage device.

30. one end of the spring is secured to a distal end of the interior chamber of the elongate member; the other end of the spring is fixed to the proximal base of a wishbone-shaped actuator in the internal chamber; a proximal end of the stylus fixed to the base; 30. The glaucoma system of claim 29, wherein two arms of the actuator extend through two slots in the elongate member, respectively, to the external space.

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