Glaucoma Device Inserter

Abstract

An inserter device for use with a glaucoma drainage device is provided, the inserter device comprising a tube having a proximal end and a distal end, wherein a lumen extends from the proximal end to the distal end. The inserter device comprises an elongated member having a distal end defining a stop surface, and a needle extending beyond the distal end of the elongated member. The needle is sized and configured to be received within the lumen of the glaucoma drainage device, wherein the stop surface interfaces with the glaucoma drainage device and limits proximal movement of the glaucoma drainage device. The needle has a first length extending beyond the stop surface, the first length being less than a second length of a portion of the lumen of the tube of the glaucoma drainage device extending beyond the stop surface. Systems and methods are also described and claimed.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims priority to U.S. Provisional Application No. 62 / 811,045, filed on February 27, 2019, the entire contents of which are incorporated herein by reference. Background Art

[0003] InnFocus, Inc. of Miami, Florida, has issued patents related to glaucoma drainage implants (GDIs) (e.g., 7,431,709, 7,594,899, 7,837,644, and 9,101,444), which are incorporated herein by reference in their entirety. Typical GDIs are Figure 1 , and includes an elongated tubular body or tube 1 having a distal end 2 and a proximal end 3. One or more projections or fins 4 extend radially from the outer surface of the tube 1 at an intermediate position between the distal end 2 and the proximal end 3. When the GDI is implanted in the eye, the (multiple) fins 4 can help prevent the tube 1 from migrating into the eye. The tube 1 also includes a bevel 6 on the distal end 2. The tube 1 has an inner cavity 5 extending from the distal end 2 to the proximal end 3. The length of the cavity 5 is Figure 1 When the GDI is implanted in the eye, cavity 5 provides a flow path for the drainage of fluid from the interior of the eye (eg, drainage of aqueous humor from the anterior chamber).

[0004] Figure 2 An example of GDI implantation or placement in the eye is shown. In this case, the distal end 2' is in the anterior chamber of the eye, and the tube 1' extends through the sclera 10 below the limbus. The proximal end 3' is located in the anatomical plane between the conjunctiva / Tenons and the sclera. Fluid (e.g., aqueous humor) from the anterior chamber flows through the cavity 5 of the GDI and is drained into the space under the conjunctiva / Tenons to form a small blister known as a bleb. The projection or (multiple) fins 4' may be located behind the limbus and may be buried in a small capsule 11 cut into the sclera with a scalpel or a triangular knife. The GDI is typically placed in this position by forming a needle channel (or tissue passage) below the limbus (region 10) through the scleral capsule 11 and into the anterior chamber. The tube G of the GDI can be clamped with forceps and inserted into the needle channel.

[0005] The GDI (particularly, the tube 1 of the GDI, and possibly the fin(s) 4) is typically made of a soft and flexible material, such as poly(styrene-block-isobutylene-block-styrene) (SIBS) having a Shore hardness of less than 60A. In embodiments, the GDI may be made of SIBS having a Shore hardness in the range of 30A to 50A, more preferably in the range of 35A to 45A, and possibly having a Shore hardness of 40A. In embodiments, the diameter of the lumen 5 of the tube 1 may be in the range of from 0.04mm to 0.1mm, more preferably in the range of 60μm to 80μm, and may be 70μm. The outer diameter of the tube 1 may be in the range of from 0.2mm to 0.8mm, and in embodiments may be 0.35mm. In these embodiments, the soft material and dimensions on both sides of the fin(s) 4 and the tube 1 make the tube 1 very soft, and therefore difficult to squeeze the needle tract under the limbus and into the anterior chamber.

[0006] Traditionally, the implantation of the device is completed with forceps, which are used to clamp the GDI at its proximal proximal end and gradually move the GDI through the capsule and the needle tract and into the anterior chamber. The problem with forceps is that the GDI needs to be clamped very carefully to avoid accidentally squeezing the cavity closed, which may take tens of minutes to rebound and open. In addition, the GDI is very small and may fall. Further, the surgeon needs to lift his / her eye from the surgical microscope to receive the GDI from the surgical assistant nurse, which is not optimal. Finally, due to the obstruction of the needle tract by fiber bundles and the like, the GDI cannot always pass through the needle tract. In short, it is inappropriate and not optimal to implant the GDI with forceps. A faster and more reliable method is needed to clamp and implant the GDI. Summary of the invention

[0007] The present disclosure describes an inserter for supporting a soft, flexible GDI during packaging, sterilization, and shipping, and for facilitating implantation of the GDI into the eye. It is contemplated that the GDI and inserter will be packaged as a glaucoma system or kit, wherein the GDI is supported by the needle of the inserter as described herein. BRIEF DESCRIPTION OF THE DRAWINGS

[0008] Figure 1 It is a cross-sectional schematic diagram of a prior art GDI.

[0009] Figure 2 It shows that Figure 1 Illustration of an example of a GDI implant or placement into an eye.

[0010] Figure 3 is a diagram showing the anatomical structures or parts of the eye.

[0011] Figure 4is a diagram showing the needle forming a needle tract (or tissue pathway) beneath the limbus to the anterior chamber of the eye.

[0012] Figure 5 It is shown by Figure 4 Illustration of the needle track formed by the needle.

[0013] Figure 6 The needle is inserted into Figure 5 Illustration of the needle path.

[0014] Fig. 7A is a diagram showing an inserter having a structure for supporting and carrying Figure 1 The GDI needle.

[0015] Figure 7B is a diagram showing an inserter having a support and a bearing Figure 1 A needle of a GDI, wherein the needle is sized and configured to extend to a distal end of the GDI.

[0016] Figure 7C is a diagram showing an inserter having a support and a bearing Figure 1 A needle of a GDI, wherein the needle is sized and configured to extend far beyond a distal end of the GDI.

[0017] Fig.7D is a diagram showing an inserter having a support and a bearing Figure 1 A needle for a GDI, wherein the needle is sized and configured such that the distal end of the needle is proximally offset a distance "d" relative to the distal end of the GDI.

[0018] Figure 8 It is shown Fig.7D An inserter is used to support and carry a needle of the inserter. Figure 1 The GDI is inserted into Figure 5 into and through the needle track.

[0019] Fig. 9 , 10 , 11A, 11B, 12A and 12B show alternative embodiments of the inserter, which are similar to Fig.7D The inserter is similar. DETAILED DESCRIPTION

[0020] In this disclosure, the term "proximal" refers to a location closer to a surgeon who is implanting the device, while "distal" refers to a location farther from a surgeon who is implanting the device.

[0021] The present disclosure describes an inserter that enables a soft, flexible GDI to be inserted into a needle tract (or tissue passage) leading to the anterior chamber of the eye, wherein the distal end 2 of the GDI is located in the anterior chamber of the eye. The inserter includes a needle that is located in and received by the cavity 5 of the GDI. The needle serves to support and carry the GDI when the GDI is inserted into and through the needle tract. For the purposes of the present disclosure, the needle may be a wire, a guidewire, a stylet, a stiffener, and the like, and will be referred to simply as a needle for simplicity. Further, in order to fit into the cavity 5 of the GDI, the maximum outer diameter of the needle may be less than the inner diameter (or cavity) of the GDI (which may be 60 to 80 μm in an embodiment). Examples of materials that may constitute the needle are stainless steel, cobalt-chromium-nickel compound (Elgiloy), nitinol, tungsten, and the like. In an embodiment, the material constituting the needle is relatively rigid (compared to the flexible material of the tube of the GDI), non-corrosive, and biocompatible.

[0022] Figure 3 Similar to Figure 2 , the conjunctiva, Tenon's fascia sac, bleb and GDI are omitted for ease of illustration. In order to insert the GDI under the limbus (where the distal end of the GDI is located in the anterior chamber of the eye), a needle 40 is used to form a needle tract (or tissue passage) under the limbus to the anterior chamber, such as in Figure 4 As shown in . Typically, before the needle track is formed, a scalpel or triangular knife is used to form a small pocket in the sclera that will ultimately house the (multiple) fins 4 of the GDI. In surgical procedures of this nature, the patient is typically instructed to look down or up in order to expose more of the sclera to facilitate the formation of the needle track and implantation of the device. It is sometimes also necessary to place a traction suture (not shown) through the partial thickness of the cornea so that the surgeon can rotate the eye by pulling on the traction suture to facilitate exposure of the sclera. Where the tissue beneath the corneoscleral limbus is compressed in these ways and the needle is forced through the tissue, it is common for the needle track so formed to be curved rather than straight when the needle 40 is removed and the eye is relaxed.

[0023] Figure 5 The needle track 50 is shown thus formed as a curved tract, and it is this curved needle track 50 that makes it difficult to use a conventional needle to facilitate placement of a GDI in the needle track, as will be explained below.

[0024] Figure 6 A needle 60 is shown having a distal end 61. The needle 60 is thin enough to slideably fit into the lumen 5 of the GDI (see FIG. Figure 1). The maximum outer diameter of the needle 60 may be approximately 10% to 30% smaller than the diameter of the lumen 5 of the GDI. For example, when the diameter of the lumen 5 of the GDI is in the range of 60 μm to 80 μm, the maximum outer diameter of the needle 60 may be in the range of 42 μm to 72 μm. The needle may be a straight wire or taper along its length. Note that a thin needle of this size may have a sharp distal end, and if made rigid enough to allow pushability, the needle 60 will not advance along the needle track 50; instead, it will penetrate the tissue adjacent to the needle track at the bend, as shown by the distal section 61 of the needle 60 protruding into the sclera.

[0025] Fig. 7A An inserter 70 is shown, which includes a handle 71, a needle 72 extending from the distal end of the handle 71, an optional grip 73, and an optional orientation mark 74. The orientation mark 74 is aligned with the plane of the bevel 6 at the distal end 2 of the GDI to indicate to the surgeon where the plane of the bevel 6 is located, because it is necessary to make the bevel face the cornea. For example, the surgeon can be guided to position the GDI on the needle 72 before inserting the GDI into the tissue tract so that the bevel 6 is in the same plane as the orientation mark 74. In this example, the needle 72 is rigidly fixed to the handle 71. In an embodiment, due to the friction between the inner cavity wall of the GDI and the needle 72, the GDI can remain positioned on the needle 72. The friction can also limit or reduce the rotational movement of the GDI around the needle 72.

[0026] Figure 7B An inserter 70-1 is shown having a needle 72-1 whose length is configured to match the length of the lumen 5 of the tube 1 of the GDI. In this configuration, the distal end 75 of the handle 71 provides a stop surface that abuts the proximal end 3 of the tube 1 of the GDI when the needle 72-1 is received within the lumen 5 of the tube 1 of the GDI. With the proximal end 3 of the tube 1 of the GDI abutting the stop surface provided by the distal end 75 of the handle 71, the needle 72-1 extends within the lumen 5 of the tube 1 of the GDI to approximately the beveled distal end 2 of the GDI. This configuration of needle 72-1 cannot be used to effectively insert a GDI into a needle track because the GDI is very flexible and, upon entering the needle track 50, will fold in the region of the distal end 2 to expose the needle 72-1, which will penetrate the tissue without advancing along the needle track 50, as described above with respect to FIG. Figure 6 As explained.

[0027] Figure 7CAn inserter 70-2 is shown having a needle 72-2 whose length is configured to be greater than the length of the lumen 5 of the tube 1 of the GDI. In this configuration, the distal end 75 of the handle 71 provides a stop surface that abuts the proximal end 3 of the tube 1 of the GDI when the needle 72-2 is received within the lumen 5 of the tube 1 of the GDI. With the proximal end 3 of the tube 1 of the GDI abutting the stop surface provided by the distal end 75 of the handle 71, the needle 72-2 extends within the lumen 5 of the tube 1 of the GDI far beyond the beveled distal end 2 of the GDI and, therefore, protrudes from the distal end 2 of the GDI. This configuration of the needle 72-2 cannot be used to effectively insert the GDI into the needle track because the distal portion of the needle 72-2 that extends beyond the beveled distal end 2 of the GDI will penetrate into the tissue without advancing along the needle track 50, as described above with respect to FIG. Figure 6 As explained.

[0028] Fig.7D An inserter 70-3 is shown having a needle 72-3 whose length L1 is configured to be less than the length L2 of the lumen 5 of the tube 1 of the GDI. In this configuration, the distal end 75 of the handle 71 provides a stop surface that abuts against the proximal end 3 of the tube 1 of the GDI (when the needle 72-3 is received in the lumen 5 of the tube 1 of the GDI) and acts to limit the proximal movement of the GDI. With the proximal end 3 of the tube 1 abutting against the stop surface provided by the distal end 75 of the handle 71, the length L1 of the needle 72-3 extends within the lumen 5 of the tube 1 of the GDI to about 1 mm from the distal end 2 of the GDI on the proximal side. This configuration of the needle 72-3 can be used to effectively insert the GDI into the needle track because the distal portion of the GDI that extends beyond the distal end of the needle 72-3 can be advanced along the needle track because the soft tube 1 of the GDI cannot penetrate tissue and can be bent to advance along the needle track. This discovery is not obvious.

[0029] Note that needle 72-3 can be stiff enough to allow the GDI to have rigidity during insertion into and through the needle track. Needle 72-3 can also be short enough not to restrict the GDI from advancing along the contour of the needle track. This operation is Figure 8 , where the distal end 80 of the tube 1 of the GDI is bent in the needle track 50, and the needle 72-3 of the inserter 70-3 provides rigidity to allow the GDI to continue to be inserted through the needle track. Once the GDI is in place, as shown Figure 2 As shown in , the needle 72-3 can be simply withdrawn or retracted from the cavity 5 of the GDI, thereby leaving the GDI in the needle channel. When the needle 72-3 of the inserter 70-3 is withdrawn or retracted from the cavity 5 of the duct 1 of the GDI, the operation can be facilitated by clamping the GDI in a suitable position with forceps.

[0030] Note that the length L1 of the needle 72-3 is configured to be less than the length L1 of the entire lumen 5 of the tube 1 of the GDI extending from the stop surface defined by the distal end 75 of the handle 71. In this configuration, with the proximal end 3 of the tube 1 of the GDI abutting the stop surface provided by the distal end 75 of the handle 1, the distal end of the needle 72-3 is displaced a distance "d" from the distal tip of the GDI, as shown in FIG. Fig.7D The displacement "d" can be determined by the difference between the overall length L2 of the lumen 5 of the tube 1 of the GDI and the length L1 of the smaller needle 72-3, as shown in Fig.7D In an embodiment, the displacement "d" (and therefore the difference between L2 of the lumen and L1 of the needle 72-3) is in the range of 0.5 to 3 mm, preferably in the range of 1 to 2 mm. It is also possible to apply a lubricant in the lumen 5 of the GDI to facilitate sliding of the needle in the lumen 5 of the GDI. Exemplary lubricants include, but are not limited to, glycerin, hyaluronic acid, and methylcellulose.

[0031] Figure 9-12B An alternative embodiment of an inserter is shown, which is similar to Fig.7D Inserter.

[0032] Fig. 9 An embodiment of an inserter 70-4 is shown, which is similar to Fig.7D , which has a removable and disposable cap 90 that can be placed on the GDI and the distal portion of the handle 71 of the inserter 70-4. The cap 90 can be designed with a notch or with loose tolerances to allow ethylene oxide sterilization and can be removed for use.

[0033] Fig.10 An embodiment of an inserter 70-5 is shown, which is similar to Fig.7D , wherein a rigid over-tube 100 is rigidly attached to the handle 71 of the inserter 70-5, which can add additional support to the needle of the inserter to help improve pushability. The over-tube 100 can be made of metallic hypodermic tubing, or can be a plastic made of polyester, Delrin, nylon, Teflon, polyimide, polysulfone, and the like. It is also contemplated that the over-tube 100 can receive and surround the proximal portion of the GDI, and can push against the (multiple) fins 4 of the GDI to improve the pushability of the GDI during insertion of the GDI into and through the needle tract as described herein. Note that the distal end of the tube 100 pushes against the fins (4) of the GDI during insertion of the GDI into and through the needle tract, while the needle provides rigidity to the GDI so as to reduce or limit the possibility that the distal end of the needle will penetrate the tube wall of the GDI during insertion.

[0034] Fig.11A and 11B An embodiment of an inserter 70-6 having a retractable needle 72-6 is shown, which is similar to Fig.7D The needle 72-6 is rigidly connected to the thumb slide 110. When the GDI is in place ( Fig.11A ), the user can retract the thumb slide 110 in the proximal direction (relative to the handle 71), such as in Fig. 11B , and the needle 72-6 is retracted so that the needle 72-6 moves proximally relative to the GDI and the needle 72-6 is removed from the lumen 5 of the tube 1 of the GDI, wherein the GDI is in place, as shown. A lock (not shown) may be incorporated into the Fig.11A and 11B 70-6 shown in the figure to lock the slide 110 (relative to the handle 71) in the Fig.11A 70-6. The lock is configured to prevent the slide 110 from moving during the transport of the inserter 70-6. When the inserter 70-6 is used, the lock can be removed or otherwise displaced to unlock the slide 110. In an embodiment, the lock can take the form of a pin that is configured to selectively cross and engage the slide 110 and the wall of the handle 71 to lock the slide 110. The pin can be selectively removed or displaced from one or both of the slide 110 and the wall of the handle 71 to unlock the slide 110 to allow the user to move the slide 110 relative to the handle 71. In addition, in an embodiment, the lock can be a block of material that fits into a tract (in which the slide 110 moves) to prevent the slide 110 from retracting or otherwise moving relative to the handle 71 (similar to a block of wood used to prevent a sliding door from opening). When the inserter 70-6 is used, the block of material can be removed from the channel to allow the user to move the slide 110 in the channel.

[0035] Fig. 12A and Fig. 12B An embodiment of an inserter 70-7 having a spring-loaded retractable needle 72-7 is shown, similar to Fig.7D , Fig.1011 , the needle 72-7 is moved proximally relative to the GDI, and with the GDI in place, the needle 72-7 is removed from the lumen 5 of the tube 1 of the GDI simply by activating the spring. In this embodiment, the handle 71 has an inner chamber 120 that accommodates a spring 121 at its proximal end. The spring 121 interfaces with a wish-bone actuator 123 that can slide or move proximally in the inner chamber 120 under user control. The actuator 123 has a proximal base 125 and opposing arms 127A, 127B. The proximal end of the needle 72-7 is rigidly fixed or captured by the base 125 of the actuator.

[0036] exist Fig. 12A In the spring-loaded configuration of the inserter 70-7 shown in the figure, the arms 127A and 127B of the actuator 123 extend distally from the base 125 through the corresponding notches 129A, 129B in the handle 71 to the external space. When the spring 121 is in a compressed state, the arms 127A, 127B abut against the proximal ends of the corresponding notches 129A, 129B and clamp the actuator 123 in place. In the spring-loaded configuration of the inserter 70-7, the distal portion of the needle 72-7 extending through the outer sleeve 100 and beyond the distal end 101 of the outer sleeve 100 can support the GDI. Specifically, as shown, the distal portion of the needle 72-7 can be inserted into the cavity 5 of the tube 1 of the GDI so that the distal portion of the needle 72-7 extends in the cavity 5 of the tube 1 of the GDI. In this configuration, the distal end 101 of the outer sleeve 100 provides a stop surface that interfaces with the fin(s) 4 of the GDI (when the needle 72-7 is received within the lumen 5 of the tube 1 of the GDI) and acts to limit proximal movement of the GDI.

[0037] With the inserter 70-7 in its spring-loaded configuration, the user / operator can apply a manual force through hand / finger pressure that pushes the arms 127A and 127B of the actuator 123 radially inward (indicated by the arrows labeled A) and releases the arms 127A, 127B from their engagement with the proximal ends of the corresponding notches 129A, 129B. This action can release the actuator 123 and allow the compressed spring 123 to expand, whereby the spring force of the compressed spring 123 causes the actuator 123 to move or slide proximally within the chamber 123, as in Fig. 12B Note that with actuator 123 connected to needle 72-7, proximal movement of actuator 123 causes needle 72-7 to move proximally or retract, such that the distal portion of needle 72-7 is removed from lumen 5 of tube 1 of the GDI, which in turn causes the distal portion of needle 72-7 to move proximally or retract. Fig. 12B is obvious.

[0038] As in Fig. 12A As shown, the length L3 of the needle 72-7 extending beyond the stop surface provided by the distal tip 101 of the outer cannula 100 is configured to be less than the length L4 of the portion of the lumen 5 of the tube 1 of the GDI extending beyond the stop surface provided by the distal tip 101 of the outer cannula 100. The inserter 70-7 is in its spring-loaded configuration, and the distal portion of the needle 72-7 is inserted into the lumen 5 of the tube 1 of the GDI such that the distal portion of the needle 72-7 extends within the lumen 5 of the tube 1 of the GDI as shown, with the distal end of the needle 72-7 displaced a distance or distance "d" from the distal tip of the GDI, as shown. Fig. 12A The displacement "d" can be determined by the difference between the length L4 of the portion of the lumen 5 of the tube 1 of the GDI that extends beyond the stop surface provided by the distal tip 101 of the outer cannula 100 and the smaller length L3 of the needle 72-7 that extends beyond the stop surface provided by the distal tip 101 of the outer cannula 100, as shown in Fig. 12A In an embodiment, the displacement "d" (and therefore the difference between L4 of the lumen and L3 of the needle 72-7) is in the range of 0.5 to 3 mm, preferably in the range of 1 to 2 mm. It is also possible to apply a lubricant in the lumen 5 of the GDI to facilitate sliding of the needle in the lumen 5 of the GDI. Exemplary lubricants include, but are not limited to, glycerin, hyaluronic acid, and methylcellulose.

[0039] In an embodiment, the needle of the inserter can be formed from a drawn wire, wherein the amount of shrinkage determines its hardness. The wire should be hard enough but not too brittle to avoid breaking when slightly bent. A variety of production methods can be used to manufacture and assemble the handle and needle assembly of the inserter. For example, the handle can be injection molded with a hole at the distal end that is sized to accommodate the needle. The needle can be cut to a predetermined length and electropolished. The cut length can be dipped in a UV-curable adhesive, inserted into the hole in the handle, and then exposed to UV light until cured. The GDI can then be mounted on the needle, and the bevel 6 of the GDI can be oriented to align with the orientation mark on the handle.

[0040] In embodiments, an inserter having a needle and a GDI may be packaged as a glaucoma system or kit, wherein the GDI is supported by the needle of the inserter. Fig.7D and Fig. 12A As shown in FIG. 1 , the needle may be located within and received by the lumen 5 of the tube 1 of the GDI.

[0041] With or without cap ( Fig. 9, 90) as described herein can be easily placed in a blister package and sterilized according to standard sterilization procedures (preferably, ethylene oxide). The fact that the needle has a diameter smaller than the cavity of the GDI allows the ethylene oxide to penetrate the length of the cavity. In addition, the inserter structure and GDI as described herein can be removed from the package and handed to the surgeon without the surgeon having to look up from the surgical microscope. The orientation markings 74 of the inserter will indicate which side is tilted up (6), and the surgeon can simply insert the device into the needle track and through the needle track to deploy the GDI to the desired implantation location, as described herein.

[0042] A number of embodiments of glaucoma device inserters have been described and illustrated herein. Although particular embodiments have been described, it is not intended that the invention be limited thereto, but rather it is intended that the invention be as broad in scope as the art will allow, and as to the specification. Therefore, it will be appreciated by those skilled in the art that further modifications may be made to the provided invention without departing from its spirit and scope as claimed.

Claims

1. An inserter device for use with a glaucoma drainage device, the glaucoma drainage device comprising a tube having a proximal end and a distal end, wherein a lumen extends from the proximal end to the distal end, the inserter device comprising: an elongated member having a distal end defining a stop surface, and the elongated member includes an outer sleeve configured to receive and surround a proximal portion of the glaucoma drainage device; as well as a needle extending beyond the distal end of the elongated member, wherein the needle is sized and configured to be received within the lumen of the glaucoma drainage device, wherein the stop surface interfaces with the glaucoma drainage device and limits proximal movement of the glaucoma drainage device as the glaucoma drainage device is inserted into and passed through the needle tract, and wherein the needle has a first length extending beyond the stop surface, the first length being less than a second length of a portion of the lumen of the tube of the glaucoma drainage device extending beyond the stop surface; The glaucoma drainage device further includes at least one protrusion extending radially from the tube of the glaucoma drainage device at an intermediate position between the proximal end and the distal end of the tube of the glaucoma drainage device, wherein the outer sleeve of the inserter device provides a distal end that defines the stop surface, and wherein the stop surface interfaces with the at least one protrusion of the glaucoma drainage device to limit proximal movement of the glaucoma drainage device.

2. The inserter device according to claim 1, characterized in that The difference between the second length of the lumen of the tube of the glaucoma drainage device and the first length of the needle is in the range of 0.5 to 3 mm.

3. The inserter device according to claim 1, characterized in that The difference between the second length of the lumen of the tube of the glaucoma drainage device and the first length of the needle is in the range of 1 to 2 mm.

4. The inserter device according to claim 1, characterized in that At least a portion of the needle is sized and configured to slide at least a portion of the needle within a lumen of a tube of the glaucoma drainage device.

5. The inserter device according to claim 1, characterized in that The inserter device further includes a lubricant that facilitates sliding movement of the needle within the lumen of the glaucoma drainage device.

6. The inserter device according to claim 1, characterized in that The needle 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 inserter device according to claim 1, characterized in that The diameter of the lumen of the tube of the glaucoma drainage device is in the range of 60 μm to 80 μm, and the needle has a maximum outer diameter in the range of 42 μm to 72 μm.

8. The inserter device according to claim 1, characterized in that The needle is made of a rigid material and the tube of the glaucoma drainage device is made of a flexible material.

9. The inserter device according to claim 8, characterized in that The material of the needle is selected from the group consisting of stainless steel, cobalt-chromium-nickel compound, nitinol, and tungsten.

10. The inserter device according to claim 8, characterized in that The material of the tube of the glaucoma drainage device is poly(styrene-block-isobutylene-block-styrene) with a Shore hardness of less than 60A.

11. The inserter device according to claim 1, characterized in that The elongated member includes an orientation marking that aligns with a bevel on a distal end of a tube of the glaucoma drainage device.

12. The inserter device according to claim 1, characterized in that The needle is retractable by manipulation of an inserter device such that the needle moves proximally relative to the glaucoma drainage device to remove the needle from the lumen of the tube of the glaucoma drainage device.

13. The inserter device according to claim 1, characterized in that The stop surface abuts against the proximal end of the glaucoma drainage device to limit the proximal movement of the glaucoma drainage device, and the first length of the needle is less than the entire length of the lumen of the tube of the glaucoma drainage device.

14. A glaucoma system comprising: A glaucoma drainage device comprising a tube having a proximal end and a distal end, wherein a lumen extends from said proximal end to said distal end; as well as an inserter device comprising an elongated member having a distal end defining a stop surface, and a needle extending beyond the distal end of the elongated member, wherein the needle is sized and configured to be received within a lumen of the glaucoma drainage device, wherein the stop surface interfaces with the glaucoma drainage device and limits proximal movement of the glaucoma drainage device as the glaucoma drainage device is inserted through a needle tract, and wherein the needle has a first length extending beyond the stop surface, the first length being less than a second length of a portion of the lumen of a tube of the glaucoma drainage device extending beyond the stop surface, and wherein the elongated member of the inserter device comprises an outer sleeve configured to receive and surround a proximal portion of the glaucoma drainage device; The glaucoma drainage device further includes at least one protrusion extending radially from the tube of the glaucoma drainage device at an intermediate position between the proximal end and the distal end of the tube of the glaucoma drainage device, wherein the outer sleeve of the inserter device provides a distal end that defines the stop surface, and wherein the stop surface interfaces with the at least one protrusion of the glaucoma drainage device to limit proximal movement of the glaucoma drainage device.

15. The glaucoma system according to 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 needle is in the range of 0.5 to 3 mm.

16. The glaucoma system according to 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 needle is in the range of 1 to 2 mm.

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

18. The glaucoma system according to claim 14, wherein: The glaucoma system further includes a lubricant that facilitates sliding movement of the needle within the lumen of the glaucoma drainage device.

19. The glaucoma system according to claim 14, wherein: The needle 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.

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

21. The glaucoma system of claim 14, wherein: The needle is made of a rigid material and the tube of the glaucoma drainage device is made of a flexible material.

22. The glaucoma system according to claim 21, wherein: The material of the needle is selected from the group consisting of stainless steel, cobalt-chromium-nickel compound, nitinol, and tungsten.

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

24. The glaucoma system of claim 14, wherein: The elongated member includes an orientation marking that aligns with a bevel on a distal end of a tube of the glaucoma drainage device.

25. The glaucoma system of claim 14, wherein: The needle is retractable by manipulation of an inserter device such that the needle moves proximally relative to the glaucoma drainage device to remove the needle from the lumen of the tube of the glaucoma drainage device.

26. The glaucoma system of claim 14, wherein: The stop surface abuts against the proximal end of the glaucoma drainage device to limit the proximal movement of the glaucoma drainage device, and the first length of the needle is less than the entire length of the lumen of the tube of the glaucoma drainage device.

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