Glaucoma drainage device with expandable anchors

Abstract

A glaucoma drainage device is provided having an elongated body for draining aqueous humor from the anterior chamber of the eye. At least one anchor or wire is configured to extend radially outward beyond the body to secure the body within the eye. The device, including the anchor or wire, is housed within the distal end of a needle inserter and deployed from there to implant the device within the eye. Deployment is performed by an extraocular or intraocular method. Once the device is loaded inside the needle inserter, the wire or anchor (or part thereof) is held in a compressed state. The wire or anchor (or part thereof) is configured to automatically expand from the compressed state to secure the device within the eye once deployed into the eye from the needle inserter. Related systems and methods for treating glaucoma are also described and claimed.

Description

Technical Field

[0001] Cross - Reference to Related Applications This application claims priority to U.S. Provisional Patent Application No. 63 / 454,006, filed on March 22, 2023, with the title "Glaucoma Drainage Device with Expandable Anchor", Attorney docket number: INN - 065P, the entire contents of which are incorporated herein by reference.

[0002] This disclosure relates to a device for flowing or draining aqueous humor from the anterior chamber of the eye.

Background Art

[0003] Aqueous humor is produced by the ciliary body of the eye, flows from the ciliary body into the anterior chamber, and then flows out into the drainage duct through a spongy tissue in the front part of the eye called the trabecular meshwork (fibrous trabecular band). In a healthy eye, the continuous drainage of aqueous humor keeps the intraocular pressure at a normal level. However, in most types of glaucoma, the proper circulation of aqueous humor is blocked, causing an increase in intraocular pressure levels. In open - angle glaucoma, the eye fluid does not flow freely through the trabecular meshwork, resulting in an increase in intraocular pressure, damage to the optic nerve, and vision loss. Lowering intraocular pressure is a means to stop the progression of damage to the optic nerve, and if the damage to the optic nerve is not treated, it may lead to blindness. Risk factors for the onset of glaucoma include high intraocular pressure (IOP), age, ethnicity, positive findings of glaucoma in the family history, and thin central corneal thickness. However, intraocular pressure remains the only risk factor that is easily treatable.

[0004] Managing intraocular pressure (IOP) is a cornerstone of glaucoma treatment. Lowering IOP through medication, laser therapy, or surgical means has long been the standard treatment for glaucoma. In current practice, initial treatment begins with medication or laser therapy. However, if IOP is not sufficiently reduced by medication or laser therapy and / or if visual field progression is not adequately prevented, surgical incision may be performed. Such surgical incisions include trabeculectomy or implantation of a glaucoma drainage device (GDD) or MIGS device that drains or removes aqueous humor from the anterior chamber of the eye. MIGS is a newer category of glaucoma drainage devices, an abbreviation for "Minimally Invasive Glaucoma Surgery," a term coined around 2012. MIGS refers to several new devices used to drain aqueous humor into the space below the conjunctiva and Tenon's capsule, into the suprachoroidal space, or into Schlemm's canal through the trabecular network. Some MIGS devices are implanted intraocularly using an extraocular procedure in which the glaucoma drainage device is inserted from the outside of the eye through a tissue passage leading to the anterior chamber. Other MIGS devices are implanted intraocularly using an intraocular procedure in which the glaucoma drainage device is inserted from a position inside the anterior chamber through a tissue passage leading to the space outside the anterior chamber. Two important MIGS devices that drain aqueous humor into the space below the conjunctiva and Tenon's capsule are the Preserflo® microshunt (Santen Pharmaceutical, Osaka, Japan) and the XEN gel stent (Allergan, Dublin, Ireland).

[0005] XEN gel stents are tubes made of cross-linked gelatin that are injected from the inside of the eye (intraocular approach) through the trabecular network beneath the limbus, terminating beneath the conjunctiva and Tenon's capsule, where they form small blisters called blebs. The problem with XEN gel stents is that the cross-linked gelatin material of the device often induces inflammation and scarring, sometimes requiring surgical intervention to restore blood flow. Although XEN gel stents are sometimes known to be expelled or rejected from the eye through the conjunctiva, they rarely migrate into the anterior chamber.

[0006] Figure 1 shows a schematic diagram of a Preserflo microshunt device 1 tethered to the sclera of a human eye, beneath the conjunctiva / Tenon's capsule (not shown). Device 1 includes a tube 2, which has opposing fins 3 positioned midway along its length. This device is best described in U.S. Patent Nos. 7,431,709, 7,594,899, 7,837,644, 9,044,301, 9,101,444, and 9,889,042, the entire contents of which are incorporated herein. The tube 3 has an internal lumen extending from a tapered or chamfered distal end 4 to a proximal end 5, which provides a channel for draining aqueous humor from the anterior chamber of the eye to a drainage bleb.

[0007] The lumen of tube 1 is designed to be small enough to restrict flow through the tube and prevent hypotension, ranging from 60 to 100 micrometers, preferably 70 micrometers. The outer diameter is set to approximately 350 micrometers, small enough not to erode tissue, and having sufficient columnar strength to be pushed in with forceps through a needle passage formed beneath the limbus. The fin 3 primarily functions as an obstruction or anchor to prevent the tube from moving into the anterior chamber (the fin 3 also functions as a cork to prevent leakage around the annular region).

[0008] Figure 2 is a sagittal view of a human eye showing a Preserflo microshunt device 1 implanted in the eye. Tube 2 is positioned beneath the conjunctiva and Tenon's capsule, and fin 2 is secured in a scleral pocket incised in the sclera. The internal lumen of tube 1 extends from the distal end 4 to the proximal end 5. The distal end 4 (lumen inlet) is located in the anterior chamber. The proximal end 5 (lumen outlet) is positioned beneath the conjunctiva and Tenon's capsule, where accumulated fluid forms small blisters called blebs.

[0009] The Preserfloh Microshunt device 1 is made from a flexible, bioinert polymer material called poly(styrene-blocked isobutylene-blocked styrene) ("SIBS"), which, overall, induces clinically insignificant inflammation and tissue reactions. In short, the Preserfloh Microshunt device 1 is not significantly encapsulated like the XEN gel stent. And, without fin 3, the device will almost certainly migrate into the anterior chamber of the eye.

[0010] The Preserfloo microshunt device 1 is implanted using an extraocular procedure, in which the conjunctiva is separated from the sclera and the distal end 4 of the tube 1 is introduced through a needle pathway (tissue passage) formed in the sclera that connects to the anterior chamber of the eye. Because the Preserfloo microshunt device 1 has a fin 3, it is not possible to fold the Preserfloo microshunt device 1 and load it into the needle for intraocular injection. The best possible method is to first form the needle pathway, then pass the Preserfloo microshunt device 1 through the needle pathway using forceps or a “holder” such as the one described in U.S. Patent Application Publication No. 2022 / 013353, place the fin 3 outside the needle pathway or in a pocket pre-formed with a knife to allow for the placement of the fin 3, and tether the fin 3 to the sclera.

[0011] Forming a needle pathway and passing the Preserflo microshunt device 1 through it can be difficult, especially if collagen threads cross the needle pathway or if the needle pathway collapses, preventing the Preserflo microshunt device 1 from sliding through it. In addition, it is impractical to form a needle pathway as part of an intraocular procedure and then find a needle pathway for passing the Preserflo microshunt device 1 through it, and it is not only impossible to implant the Preserflo microshunt device 1 using an intraocular procedure, as the device will move into the eye if the fin 3 is on the wrong side of the needle pathway.

[0012] The suprachoroidal space is the intraocular space between the sclera and the choroid. It is known that aqueous humor from the suprachoroidal space drains from there, causing a decrease in intraocular pressure. Although it is not well understood where the aqueous humor drains after reaching the suprachoroidal space, some literature suggests that it drains into the choroidal blood vessels, scleral venous plexus, and suprascleral veins.

[0013] Alcon Laboratories, Inc. of Fort Worth, Texas, has developed the CyPass® microstent, which includes a tubular body with an internal lumen that drains aqueous humor from the anterior chamber of the eye into the suprachoroidal space to lower intraocular pressure. The CyPass microstent is made of polyimide (PI) polymer. The tubular body has an inner diameter of 300 microns, an outer diameter of 430 microns, and a total length of 6.35 mm. The device includes three external retention rings formed on the outer surface of the tubular body, which prevent the device from moving after implantation and serve as landmarks during placement. The tubular body also has 64 perforations or orifices that penetrate the tubular body and lead to the internal lumen, ensuring that the device continues to drain aqueous humor if the distal end of the lumen becomes blocked. Based on an analysis of a 5-year postoperative dataset showing that patients who received CyPass microstents experienced statistically significant endothelial cell loss at 5 years compared to patients who underwent cataract surgery alone, CyPass microstents were voluntarily withdrawn from the market in August 2018.

[0014] iSTAR Medical, based in Waffel, Belgium, has developed the MINIject® device, which has been approved in Europe for the treatment of glaucoma. The MINIject device consists of a slender, lumen-less body made from medical-grade porous silicone material. This body drains aqueous humor from the anterior chamber of the eye into the suprachoroidal space, thereby lowering intraocular pressure. The slender body of the MINIject device does not have features to prevent the device from moving into the anterior chamber after implantation, and such movement can be problematic. For example, such movement of the device may obstruct the drainage of aqueous humor, potentially hindering the treatment of glaucoma. [Brief explanation of the drawing]

[0015] [Figure 1] Figure 1 of the prior art shows a schematic diagram of a Preserflo Microshunt device tethered to the sclera of the human eye, beneath the conjunctiva / Tenon's capsule (not shown). [Figure 2] Figure 2, representing the conventional technology, is a sagittal view of the eye with the Preserflo Microshunt device shown in Figure 1 implanted inside the eye. [Figure 3] Figure 3 is a schematic diagram of an exemplary embodiment of a glaucoma drainage device according to the present disclosure. [Figure 4] Figure 4 is a schematic diagram of an exemplary embodiment of the glaucoma drainage device according to the present disclosure. [Figure 5] Figure 5 is a schematic diagram of an exemplary embodiment of a glaucoma drainage device according to the present disclosure. [Figure 6] Figure 6 is a schematic diagram of an exemplary embodiment of a glaucoma drainage device according to the present disclosure. [Figure 7] Figure 7 is a schematic diagram of an exemplary embodiment of a glaucoma drainage device according to the present disclosure. [Figure 8] Figure 8 is a schematic diagram of an exemplary embodiment of a glaucoma drainage device according to the present disclosure. [Figure 9] Figure 9 is a schematic diagram of the glaucoma drainage device shown in Figure 6, held within the distal end of a rigid, hollow needle inserter. [Figure 10] Figure 10 is a schematic diagram showing the deployment of the glaucoma drainage device from Figure 6, starting from the distal end of the rigid, hollow needle inserter. [Figure 11] Figure 11 is a schematic diagram of the glaucoma drainage device shown in Figure 6 when positioned in a needle pathway that penetrates the ocular tissue. [Figure 12] Figure 12 is a schematic diagram of a glaucoma drainage device similar to the embodiment in Figure 6, held within the distal end of a rigid, hollow needle inserter. [Figure 13] Figure 13 is a schematic diagram showing the deployment of the glaucoma drainage device from the distal end of the rigid, hollow needle inserter shown in Figure 12. [Figure 14]Figure 14 is a cross-sectional view of the glaucoma drainage device of FIGS. 12 and 13 when disposed in a needle path (e.g., the needle path shown in FIG. 11) penetrating the eye tissue. [Figure 15] Figure 15 is a schematic view of a glaucoma drainage device similar to the embodiment of FIG. 6 held within the distal end of another rigid hollow needle inserter. [Figure 16] Figure 16 is a schematic view showing the deployment of the glaucoma drainage device from the distal end of the rigid hollow needle inserter of FIG. 15. [Figure 17] Figure 17 is a schematic view of an exemplary embodiment of the glaucoma drainage device according to the present disclosure. [Figure 18] Figure 18 is a schematic view of an exemplary embodiment of the glaucoma drainage device according to the present disclosure. [Figure 19] Figure 19 is a schematic view of an exemplary embodiment of the glaucoma drainage device according to the present disclosure.

MODE FOR CARRYING OUT THE INVENTION

[0016] The present disclosure includes a simple glaucoma drainage device that can be housed within a hollow needle inserter and deployed into the eye in one shot from the hollow needle inserter, eliminating the need to pre-form a needle path. Further, the glaucoma drainage device can be implanted into the eye using an ab externo procedure. Alternatively, the glaucoma drainage device can be implanted into the eye using an ab interno procedure. These features are beneficial to the patient.

[0017] For the purposes of this disclosure, in an extraocular procedure, the glaucoma drainage device is implanted intraocularly by inserting the device through a tissue passage leading to the anterior chamber of the eye. In an intraocular procedure, the glaucoma drainage device is implanted intraocularly through an incision in the cornea, and then from a position inside the anterior chamber through a tissue passage leading to a drainage space outside the anterior chamber. In either an extraocular or intraocular procedure, the glaucoma drainage device drains aqueous humor from the anterior chamber into a drainage space such as the drainage space below the conjunctiva and Tenon's capsule or the suprachoroidal space (i.e., the space between the sclera and the choroid).

[0018] Furthermore, the term "distal" generally refers to the direction away from the user / physician implanting the glaucoma drainage device. Conversely, the term "proximal" generally refers to the direction towards the user / physician implanting the glaucoma drainage device.

[0019] In the following description, anchors or wires are referred to. In embodiments, anchors or wires are made from metals such as nickel-titanium alloy, cobalt-chromium-nickel alloy, MP35N, titanium, stainless steel, tantalum, and equivalents thereof. The device, including the anchor or wire, is housed within the distal end of a rigid, hollow needle inserter, from which it is deployed for intraocular implantation. Intraocular implantation of the device is performed using an extraocular procedure in which the distal end of the hollow needle inserter penetrates from the outer space of the eye, under the limbus, into the anterior chamber, forming a needle pathway (i.e., a tissue passage) that connects to the anterior chamber of the eye through the ocular tissue for intraocular deployment of the device. Alternatively, intraocular implantation of the device is performed using an intraocular procedure in which the distal end of the hollow needle inserter is first positioned medially into the anterior chamber of the eye via a corneal incision, and then penetrates from the anterior chamber to the outer space (such as a drainage space), forming a needle pathway (i.e., a tissue passage) that leads from the anterior chamber of the eye through the ocular tissue for intraocular deployment of the device. When the device is loaded inside the distal end of the hollow needle inserter, the wire or anchor (or part thereof) is held in a compressed state. With the distal end of the hollow needle inserter positioned in the needle pathway and the anchor or wire positioned within the needle pathway, the glaucoma drainage device can be deployed from the distal end of the hollow needle inserter. In this configuration, the wire or anchor (or part thereof) is configured to automatically recoil outward from the compressed state (e.g., by self-expansion), contacting or catching on the ocular tissue of the needle pathway and mechanically securing or fixing the device in the deployed position within the eye, thereby preventing unwanted movement of the device into the anterior chamber of the eye. In embodiments, the device's anchors or wires are formed as wires or coiled wires having diameters ranging from 0.0254 mm (0.001 inches) to 0.2032 mm (0.008 inches), preferably between 0.0508 mm (0.002 inches) and 0.1016 mm (0.004 inches). Once the device is implanted intraocularly using an extraocular procedure, the distal end of the device's drainage tube is positioned in the anterior chamber of the eye, and the proximal end of the drainage tube is positioned in a drainage space such as the conjunctiva and Tenon's capsule or the suprachoroidal space.When the device is implanted in the eye using an intraocular procedure, the distal end of the device's drainage tube is positioned in a drainage space such as the conjunctiva and Tenon's capsule or the suprachoroidal space, while the proximal end of the drainage tube is positioned inside the anterior chamber of the eye.

[0020] Figure 3 shows an exemplary embodiment of a glaucoma drainage device 30 of the present disclosure, having a drainage tube 31 supporting a thin sleeve 32 positioned above the tube 31 between opposing ends 35a, 35b. The drainage tube 31 has an internal lumen (similar to the lumen 112 in Figure 14) that extends between opposing ends 35a, 35b and provides a channel for draining aqueous humor from the anterior chamber of the eye to a drainage location or bleb. The sleeve 32 holds wire portions 33, 34 in place, which function as anchors or wires as described herein. As shown, the wire portions 33, 34 can be bent radially away from the longitudinal axis of the tube 31. When the device 30 is loaded inside the distal end of a hollow needle inserter, the wire portions 33, 34 are held in a compressed state. With the distal end of the hollow needle inserter positioned in the needle pathway and the wire sections 33 and 34 positioned within the needle pathway, the glaucoma drainage device 30 can be deployed from the distal end of the hollow needle inserter. In this configuration, the wire sections 33 and 34 automatically recoil from a compressed state (e.g., by self-expansion) and expand radially outward, contacting or catching on the ocular tissue of the needle pathway and mechanically securing or fixing the device 30 in the deployed position within the eye, thereby preventing unwanted movement of the device into the anterior chamber of the eye. In embodiments, the wire sections 33 and 34 are formed from wires having a wire diameter in the range of 0.001 to 0.008 inches, preferably between 0.002 and 0.004 inches. The wire sections 33 and 34 are either two separate wires or a single continuous wire. In alternative embodiments, the device 30 can use only one wire (i.e., 33 or 34) extending from one side of the sleeve 32. The device 30 (including wire sections 33 and / or 34) is housed within the distal end of a hollow needle inserter (as in Figures 9 and 10) and deployed from there for implantation of the device into the eye. Deployment can be performed as part of an extraocular procedure in which the distal end of the hollow needle inserter penetrates through the ocular tissue to the anterior chamber for deployment of the device 30 within the eye.When the device 30 is implanted intraocularly using an extraocular procedure, the distal end (e.g., end 35b) of the drainage tube 31 of the device 30 is positioned in the anterior chamber of the eye, and the proximal end (e.g., end 35a) of the drainage tube 31 is positioned in a drainage space such as the conjunctiva and Tenon's capsule or the suprachoroidal space. Alternatively, deployment can be performed as part of an intraocular procedure in which the distal end of a hollow needle inserter is first positioned medially into the anterior chamber of the eye via a corneal incision, and then penetrates the ocular tissue to a drainage space such as the conjunctiva and Tenon's capsule or the suprachoroidal space for intraocular deployment of the device 30. Once the device 30 is implanted in the eye using an intraocular procedure, the distal end (e.g., end 35b) of the drainage tube 31 of the device 30 is positioned in a drainage space such as the conjunctiva and Tenon's capsule or the suprachoroidal space, while the proximal end (e.g., end 35a) of the drainage tube 31 is positioned inside the anterior chamber of the eye.

[0021] Figure 4 shows another exemplary embodiment of a glaucoma drainage device 40 of the present disclosure, having a drainage tube 41 having an internal lumen (similar to the lumen 112 in Figure 14) that extends between opposing ends 45a, 45b and provides a channel for draining aqueous humor from the anterior chamber of the eye to a drainage location or bleb. Instead of a sleeve 32 (as used in the embodiment of Figure 3), wire sections 43, 44 are fed into secondary channels (shown as dashed lines) in the tube 41, or simply pierce through the material forming the wall of the tube 41 so that the wire sections 43, 44 are mechanically anchored to the central portion of the tube 41. The wire sections 43, 44 function as anchors or wires as described herein. As shown, the wire sections 43, 44 can be bent radially away from the longitudinal axis of the tube 41. When the device 40 is loaded inside the distal end of a hollow needle inserter, the wire sections 43, 44 are held in a compressed state. With the distal end of the hollow needle inserter positioned in the needle pathway and the wire sections 43 and 44 positioned within the needle pathway, the glaucoma drainage device 40 can be deployed from the distal end of the hollow needle inserter. In this configuration, the wire sections 43 and 44 automatically recoil from a compressed state (e.g., by self-expansion) and expand radially outward, contacting or catching on the ocular tissue of the needle pathway and mechanically securing or fixing the device 40 in its deployed position within the eye, thereby preventing unwanted movement of the device into the anterior chamber of the eye. In embodiments, the wire sections 43 and 44 are formed from wires having a wire diameter in the range of 0.001 to 0.008 inches, preferably between 0.002 and 0.004 inches. The wire sections 43 and 44 are either two separate wires or a single continuous wire. In alternative embodiments, the device 40 can use only one wire (i.e., 43 or 44) extending from the tube 41. The device 40 (including wire sections 43 and / or 44) is housed within the distal end of a hollow needle inserter (as in Figures 9 and 10) and deployed from there for implantation of the device into the eye. Deployment can be performed as part of an extraocular procedure in which the distal end of the hollow needle inserter penetrates the ocular tissue into the anterior chamber for deployment of the device 40 within the eye.When the device 40 is implanted intraocularly using an extraocular procedure, the distal end (e.g., end 45b) of the drainage tube 41 of the device 40 is positioned in the anterior chamber of the eye, and the proximal end (e.g., end 45a) of the drainage tube 41 is positioned in a drainage space such as the conjunctiva and Tenon's capsule or the suprachoroidal space. Alternatively, deployment can be performed as part of an intraocular procedure in which the distal end of a hollow needle inserter is first positioned medially into the anterior chamber of the eye via a corneal incision, and then penetrates the ocular tissue to a drainage space such as the conjunctiva and Tenon's capsule or the suprachoroidal space. Once the device 40 is implanted in the eye using an intraocular procedure, the distal end (e.g., end 45b) of the drainage tube 41 of the device 40 is positioned in a drainage space such as the conjunctiva and Tenon's capsule or the suprachoroidal space, while the proximal end (e.g., end 45a) of the drainage tube 41 is positioned medially within the anterior chamber of the eye.

[0022] Figure 5 shows yet another exemplary embodiment of a glaucoma drainage device 50 of the present disclosure, having a drainage tube 51 having an internal lumen (similar to the lumen 112 in Figure 14) that extends between opposing ends 55a, 55b and provides a channel for draining aqueous humor from the anterior chamber of the eye to a drainage location or bleb. A wire spring 52 is wrapped around the central portion of the tube 51 between the opposing ends 55a, 55b so that the wire spring 52 is mechanically anchored to the central portion of the tube 51. The wire spring 52 and its ends 53, 54 function as anchors or wires as described herein. As shown, the wire portions 53, 54 can be bent radially away from the longitudinal axis of the tube 51. When the device 50 is loaded inside the distal end of a hollow needle inserter, the wire portions 53, 54 are held in a compressed state. With the distal end of the hollow needle inserter positioned in the needle path and the wire sections 53 and 54 positioned within the needle path, the glaucoma drainage device 50 can be deployed from the distal end of the hollow needle inserter. In this configuration, the wire sections 53 and 54 automatically recoil from a compressed state (e.g., by self-expansion) and expand radially outward, contacting or catching on the ocular tissue of the needle path and mechanically anchoring or fixing the device 50 in the deployed position within the eye, thereby preventing unwanted movement of the device into the anterior chamber of the eye. In embodiments, the wire spring 52 (including the wire sections 53 and 54) can use a wire having a wire diameter in the range of 0.001 to 0.008 inches, preferably between 0.002 and 0.004 inches. In alternative embodiments, the device 50 can use only one wire section (i.e., 53 or 54) extending from the tube 51. The device 50 (including wire sections 53 and / or 54) is housed within the distal end of a hollow needle inserter (as in Figures 9 and 10) and deployed from there for implantation of the device into the eye. Deployment can be performed as part of an extraocular procedure in which the distal end of the hollow needle inserter penetrates the ocular tissue into the anterior chamber for deployment of the device 50 within the eye.When the device 50 is implanted intraocularly using an extraocular procedure, the distal end (e.g., end 55b) of the drainage tube 51 of the device 50 is positioned in the anterior chamber of the eye, and the proximal end (e.g., end 55a) of the drainage tube 51 is positioned in a drainage space such as the conjunctiva and Tenon's capsule or the suprachoroidal space. Alternatively, deployment can be performed as part of an intraocular procedure in which the distal end of a hollow needle inserter is first positioned medially into the anterior chamber of the eye via a corneal incision, and then penetrates the ocular tissue to a drainage space such as the conjunctiva and Tenon's capsule or the suprachoroidal space. Once the device 50 is implanted in the eye using an intraocular procedure, the distal end (e.g., end 55b) of the drainage tube 51 of the device 50 is positioned in a drainage space such as the conjunctiva and Tenon's capsule or the suprachoroidal space, while the proximal end (e.g., end 55a) of the drainage tube 51 is positioned medially within the anterior chamber of the eye.

[0023] It should be noted that the embodiments in Figures 3, 4, and 5 are symmetrical, with the wire or anchor extending from the outer annular surface of the tube on both sides of a fixture that holds it in place. The embodiments may have the wire or anchor on only one side of the fixture. If one side includes the wire or anchor, preferably the wire or anchor is oriented so as to be located on the anterior chamber side of the tube to prevent the wire or anchor from moving into the anterior chamber of the eye.

[0024] Figure 6 shows yet another exemplary embodiment of a glaucoma drainage device 60 of the present disclosure, having a drainage tube 61 having an internal lumen (similar to the lumen 112 in Figure 14) that extends between opposing ends 65a, 65b and provides a channel for draining aqueous humor from the anterior chamber of the eye to a drainage location or bleb. A spring anchor 62 formed of a coiled wire is configured to wrap around the central portion of the tube 61 between the opposing ends 65a, 65b. The spring anchor 62 has a smaller diameter coiled section 63 and a larger diameter flared coiled section 64. The smaller diameter coiled section 63 is mechanically anchored to the central portion of the tube 61. The spring anchor 62 functions as an anchor or wire as described herein. When the device 60 is loaded inside the distal end of a hollow needle inserter, the flared coiled section 64 is held in a compressed state. With the distal end of the hollow needle inserter positioned in the needle pathway and the spring anchor 62 positioned within the needle pathway, the glaucoma drainage device 60 can be deployed from the distal end of the hollow needle inserter. In this configuration, the flared coil section 64 automatically recoils from a compressed state (e.g., by self-expansion) and expands radially outward, contacting the ocular tissue of the needle pathway and mechanically anchoring or fixing the device 60 to its deployed position in the eye, thereby preventing unwanted movement of the device into the anterior chamber of the eye. In embodiments, the spring anchor 62 (including the smaller diameter coil section 63 and the flared coil section 64) can be made of a wire having a diameter in the range of 0.001 to 0.008 inches, preferably between 0.002 and 0.004 inches. The device 60 (including the spring anchor 62) is housed within the distal end of the hollow needle inserter and deployed from there for implantation of the device in the eye (see Figures 9 and 10). Deployment can be performed as part of an extraocular procedure in which the distal end of a hollow needle inserter penetrates the ocular tissue into the anterior chamber for the deployment of the device 60 within the eye.When the device 60 is implanted intraocularly using an extraocular procedure, the distal end (e.g., end 65b) of the drainage tube 61 of the device 60 is positioned in the anterior chamber of the eye, and the proximal end (e.g., end 65a) of the drainage tube 61 is positioned in a drainage space such as the conjunctiva and Tenon's capsule or the suprachoroidal space. Alternatively, deployment can be performed as part of an intraocular procedure in which the distal end of a hollow needle inserter is first positioned medially into the anterior chamber of the eye via a corneal incision, and then penetrates the ocular tissue to a drainage space such as the conjunctiva and Tenon's capsule or the suprachoroidal space. Once the device 60 is implanted in the eye using an intraocular procedure, the distal end (e.g., end 65b) of the drainage tube 61 of the device 60 is positioned in a drainage space such as the conjunctiva and Tenon's capsule or the suprachoroidal space, while the proximal end (e.g., end 65a) of the drainage tube 61 is positioned medially within the anterior chamber of the eye.

[0025] Figure 7 shows another exemplary glaucoma drainage device 70 of the present disclosure, which is a symmetrical version similar to the embodiment in Figure 6 and has a spring anchor 72 formed by a coiled wire configured to wrap around the central portion of a tube 71 between its opposing ends 75a, 75b. The tube 71 has an internal lumen (similar to the lumen 112 in Figure 14) that extends between the opposing ends 75a, 75b and provides a channel for draining aqueous humor from the anterior chamber of the eye to a drainage site or bleb. The spring anchor 72 has larger diameter flared coil sections 74a, 74b positioned on either side of a smaller diameter coil section 73. The spring anchor 72 functions as an anchor or wire as described herein. When the device 70 is loaded inside the distal end of a hollow needle inserter, the flared coil sections 74a, 74b are held in a compressed state. With the distal end of the hollow needle inserter positioned in the needle pathway and the spring anchor 72 positioned within the needle pathway, the glaucoma drainage device 70 can be deployed from the distal end of the hollow needle inserter. In this configuration, the flared coil sections 74a and 74b automatically recoil radially outward from a compressed state (e.g., by self-expansion), contacting the ocular tissue of the needle pathway and mechanically anchoring or fixing the device 70 to its deployed position in the eye, thereby preventing unwanted movement of the device into the anterior chamber of the eye. In embodiments, the spring anchor 72 (including the smaller diameter coil section 73 and the flared coil sections 74a and 74b) can be made of a wire having a diameter in the range of 0.001 to 0.008 inches, preferably between 0.002 and 0.004 inches. The device 70, including the spring anchor 72, is housed within the distal end of a hollow needle inserter (as in Figures 9 and 10) and deployed from there to implant the device into the eye. Deployment can be performed as part of an extraocular procedure in which the distal end of the hollow needle inserter penetrates the ocular tissue into the anterior chamber for deployment of the device 70 within the eye.When the device 70 is implanted intraocularly using an extraocular procedure, the distal end (e.g., end 75b) of the drainage tube 71 of the device 70 is positioned in the anterior chamber of the eye, and the proximal end (e.g., end 75a) of the drainage tube 71 is positioned in a drainage space such as the conjunctiva and Tenon's capsule outside the eye. Alternatively, deployment can be performed as part of an intraocular procedure in which the distal end of a hollow needle inserter is first positioned inside the anterior chamber of the eye via a corneal incision, and then penetrates the ocular tissue to a drainage space such as the conjunctiva and Tenon's capsule for deployment of the device 70 intraocularly. Once the device 70 is implanted in the eye using an intraocular procedure, the distal end (e.g., end 75b) of the drainage tube 71 of the device 70 is positioned in a drainage space such as the drainage space beneath the conjunctiva and Tenon's capsule of the eye, and the proximal end (e.g., end 75a) of the drainage tube 71 is positioned inside the anterior chamber of the eye.

[0026] Figure 8 shows yet another exemplary glaucoma drainage device 80 of the present disclosure, which is similar to the embodiments in Figures 6 and 7 and has a spring anchor 82 formed by a coiled wire configured to wrap around the central portion of a tube 81 between its opposing ends 85a, 85b. The tube 81 has an internal lumen (similar to the lumen 112 in Figure 14) that extends between the opposing ends 85a, 85b and provides a channel for draining aqueous humor from the anterior chamber of the eye to a drainage place or bleb. The spring anchor 82 has smaller diameter coil sections 84, 85 positioned on either side of the flared coil section 83. The smaller diameter coil sections 84, 85 and the flared coil section 83 function as an anchor or wire as described herein. When the device 80 is loaded inside the distal end of a hollow needle inserter, the flared coil section 83 is held in a compressed state. With the distal end of the hollow needle inserter positioned in the needle pathway and the spring anchor 82 positioned within the needle pathway, the glaucoma drainage device 80 can be deployed from the distal end of the hollow needle inserter. In this configuration, the flared coil section 83 automatically recoils from a compressed state (e.g., by self-expansion) and expands radially outward, contacting the ocular tissue of the needle pathway and mechanically anchoring or fixing the device 80 to its deployed position in the eye, thereby preventing unwanted movement of the device into the anterior chamber of the eye. In embodiments, smaller diameter coil sections 84, 85 and the flared coil section 83 can be made of wires having a diameter in the range of 0.001 inches to 0.008 inches, preferably between 0.002 inches and 0.004 inches. The device 80 is housed within the distal end of the hollow needle inserter (as in Figures 9 and 10) and deployed from there for implantation of the device in the eye. Deployment can be performed as part of an extraocular procedure in which the distal end of a hollow needle inserter penetrates the ocular tissue into the anterior chamber for deployment of the device 80 within the eye. Once the device 80 is implanted within the eye using the extraocular procedure, the distal end (e.g., end 85b) of the drainage tube 81 of the device 80 is positioned in the anterior chamber of the eye, and the proximal end (e.g., end 85a) of the drainage tube 81 is positioned in a drainage space such as the conjunctiva and Tenon's capsule or the suprachoroidal space.Alternatively, deployment can be performed as part of an intraocular procedure in which the distal end of a hollow needle inserter is first positioned medially into the anterior chamber of the eye via a corneal incision, and then penetrates the ocular tissue to a drainage space such as the conjunctiva and Tenon's capsule or the suprachoroidal space. Once the device 80 is implanted intraocularly using the intraocular procedure, the distal end (e.g., end 85b) of the drainage tube 81 of the device 80 is positioned in a drainage space such as the conjunctiva and Tenon's capsule or the suprachoroidal space, and the proximal end (e.g., end 85a) of the drainage tube 81 is positioned medially into the anterior chamber of the eye.

[0027] Figure 9 shows the distal end of an exemplary rigid hollow needle injector 90 having a sharp tissue puncture needle tip 91. The distal end of the rigid hollow needle injector 90 defines a chamber that houses the device 60 or a portion thereof (an embodiment in Figure 6) including a spring anchor 62 (including a smaller diameter coil section 63 and a compressed flared coil section 64). The rigid hollow needle injector 90 with the sharp tissue puncture needle tip 91 is used to puncture ocular tissue to form a needle path that will receive the drainage device 60 and the spring anchor 62 during intraocular implantation. The hollow needle injector 90 may include a pusher rod 96 positioned close to the proximal end 65a of the tube 61 of the device 60. The distal end of the pusher rod 96 is configured to push the proximal end 65a to deploy the device 60 from the distal chamber of the hollow needle injector 90, as shown in Figure 10. As shown in the figure, the pusher rod 96 is configured to support an optional stiffener stylus 97 extending from the distal end of the pusher rod 96 through the lumen into the lumen of the device 60. The stiffener stylus 97 is formed from a metal filament having a diameter smaller than the diameter of the lumen of the device 60. The stiffener stylus 97 can support the tube 61 of the device 60 during deployment to minimize buckling of such tube 61 during deployment that may occur due to the flexible structure of the tube 61.

[0028] Figure 10 shows the rigid hollow needle inserter 90 of Figure 9, with the push rod 96 held in a stationary position and the needle tip 91 slid backward relative to the push rod 96 to release the flared section 64 of the anchor 62 and the rest of the drainage device 60 for intraocular deployment of the device. When the device is deployed intraocularly from the distal chamber of the rigid hollow needle inserter 90, the flared coil section 64 is configured to automatically recoil radially outward against the compressed state (e.g., by self-expansion) and contact the ocular tissue in the needle path formed by the hollow needle inserter 90, mechanically anchoring or fixing the device 60 in the intraocular deployment position, thereby preventing unwanted movement of the device into the anterior chamber of the eye. Deployment can be performed as part of an extraocular procedure in which the needle tip 91 of the rigid needle inserter 90 penetrates the ocular tissue into the anterior chamber for intraocular deployment of the device 60. Alternatively, deployment can be performed as part of an intraocular procedure in which the needle tip 91 of the needle inserter 90 is first positioned inside the anterior chamber through a corneal incision, and then penetrates the ocular tissue to a drainage space such as the conjunctiva and Tenon's capsule or the suprachoroidal space.

[0029] Figure 11 shows a sagittal image of the eye with the drainage device 60 anchored by the flare coil section 64 of the anchor 62 within the needle path formed by the hollow needle inserter of Figure 10.

[0030] Figures 12 and 13 show yet another exemplary glaucoma drainage device 60' of the present disclosure, similar to the embodiment in Figure 6. In this embodiment, the coil sections 63, 64 of the spring anchor 62 are covered or lined with a thin sheath 111. Part of the sheath 111 can be bonded or joined to the outer surface of the coil section 63 and / or tube 61 to form a seal around the entire circumference of the tube 61, and another part of the sheath 111 is configured to expand together with the flared coil section 64 around the entire circumference of the tube 61. When the flared coil section 64 is expanded, the sheath 111 can come into contact with the surrounding tissue so that the sheath 111 prevents the flow or leakage of aqueous humor around the annular circumference. The sheath 111 is made from a flexible porous or non-porous elastomer polymer fabric, such as a fabric formed from stretched polytetrafluoroethylene (xPTFE), Dacron®, polyurethane, SIBS and equivalents thereof. The sheath 111 may be similar to a sheath used for a stent graft or lumen graft. In this embodiment, the spring anchor 62 can function as a mechanism to support the umbrella-shaped sheath 111, which prevents the flow or leakage of aqueous humor around the annular when opened in the needle passage.

[0031] Figure 12 shows the distal end of an exemplary rigid hollow needle injector 90 having a sharp tissue puncture needle tip 91. The distal end of the rigid hollow needle injector 90 defines a chamber that houses a device 60' including a spring anchor 62 with a sheath 111. The rigid hollow needle injector 90 with the sharp tissue puncture needle tip 91 is used to puncture ocular tissue to form a needle pathway that will receive the drainage device 60', spring anchor 62 and sheath 111 during intraocular implantation. The hollow needle injector 90 may include a pusher rod 96 positioned close to the proximal end 65a of the tube 61 of the device 60'. The distal end of the pusher rod 96 is configured to push the proximal end 65a to deploy the device 60' from the distal chamber of the hollow needle injector 90, as shown in Figure 13. As shown in the figure, the pusher rod 96 is configured to support an optional reinforcing stylus 97 extending from the distal end of the pusher rod 96 through the lumen into the lumen of the device 60. The reinforcing stylus 97 is formed from a metal filament having a diameter smaller than the diameter of the lumen of the device 60'. The reinforcing stylus 97 can support the tube 61 of the device 60' during deployment to minimize buckling of such tube 61 during deployment that may occur due to the flexible structure of the tube 61.

[0032] Figure 13 shows the rigid hollow needle inserter 90 of Figure 12, with the push rod 96 held in a stationary position and the needle tip 91 slid backward relative to the push rod 96 to release the flared section 64 of the anchor 62, the sheath 111, and the rest of the drainage device 60' for deployment of the device in the eye. When the device 60' is deployed in the eye from the distal end of the rigid hollow needle inserter 90, the flared coil section 64 is configured to automatically recoil radially outward against a compressed state (e.g., by self-expansion) and contact the ocular tissue of the needle path, mechanically anchoring or fixing the device in the deployed position in the eye, thereby preventing unwanted movement of the device into the anterior chamber of the eye. In this configuration, the spring anchor 62 can function as a mechanism to support the umbrella-shaped sheath 111, which prevents unwanted periannular leakage of aqueous humor around the outer annular surface of the tube 61 of the device 60' when opened in the needle path. Deployment can be performed as part of an extraocular procedure in which the needle tip 91 of the hollow needle inserter 90 penetrates the ocular tissue to the anterior chamber for intraocular deployment of the device. Once the device 60' is implanted intraocularly using the extraocular procedure, the distal end (e.g., end 65b) of the drainage tube 61 of the device 60' is positioned in the anterior chamber of the eye, and the proximal end (e.g., end 65a) of the drainage tube 61 is positioned in a drainage space such as the conjunctiva and Tenon's capsule or the suprachoroidal space. Alternatively, deployment can be performed as part of an intraocular procedure in which the distal end of the hollow needle inserter 90 is first positioned medially into the anterior chamber via a corneal incision, and then penetrates the ocular tissue to a drainage space such as the conjunctiva and Tenon's capsule or the suprachoroidal space. Once the device 60' is implanted in the eye using an intraocular procedure, the distal end (e.g., end 65b) of the drainage tube 61 of the device 60' is positioned in a drainage space such as the conjunctiva and Tenon's capsule or the suprachoroidal space, while the proximal end (e.g., end 65a) of the drainage tube 61 is positioned medially within the anterior chamber of the eye.

[0033] Figure 14 is a cross-sectional view of 14-14 in Figure 13, showing the device 60' in the needle passage through the ocular tissue 113. In the center is a tube 61 having a lumen 112, surrounded by a spring anchor 62. A thin sheath 111 is positioned around the outer surface of the flared area 64 of the anchor 62. The sheath 111 extends from the outer surface of the tube 61 and surrounds the periphery of the tube 61, allowing it to contact the surrounding tissue 113, thereby effectively preventing unwanted flow of aqueous humor in the needle passage formed outside the tube 92 and in the tissue 113. This unwanted flow of aqueous humor is commonly referred to as annular pericircumferential leakage of aqueous humor.

[0034] Figures 15 and 16 show an exemplary rigid hollow needle inserter 90' used for deploying the glaucoma drainage device 60' of Figures 12 and 13. Figure 15 shows the distal end of an exemplary rigid hollow needle inserter 90' having a sharp tissue puncture needle tip 91. The distal end of the rigid hollow needle inserter 90' defines a chamber that houses the device 60', including a spring anchor 62 with a sheath 111. The rigid hollow needle inserter 90' with the sharp tissue puncture needle tip 91 is used to puncture ocular tissue to form a needle pathway that will receive the drainage device 60', spring anchor 62, and sheath 111 during implantation into the eye. The hollow needle inserter 90' may include a pusher rod 96' having one or more projections or other features 96a located at the distal end of the pusher rod 96. The projection or other feature 96a is positioned around and / or surrounds the proximal end 65a of the tube 61 of the device 60'. The projection or other feature 96a is configured to push the proximal end (or other part) of the spring anchor 62 to deploy the device 60' from the distal chamber of the hollow needle inserter 90', as shown in Figure 16. As illustrated, the pusher rod 96 is configured to support an optional reinforcing stylus 97 extending from the distal end of the pusher rod 96 through the lumen into the lumen of the device 60. The reinforcing stylus 97 is formed from a metal filament having a diameter smaller than the diameter of the lumen of the device 60'. The reinforcing stylus 97 can support the tube 61 of the device 60' during deployment to minimize buckling of the tube 61 during such deployment that may occur due to the flexible structure of the tube 61.

[0035] Figure 16 shows the rigid hollow needle inserter 90' of Figure 15, with the push rod 96' held in a stationary position and the needle tip 91 slid backward relative to the push rod 96' to release the flared section 64 of the anchor 62, the sheath 111, and the rest of the drainage device 60' for intraocular deployment. When the device 60' is deployed intraocularly from the distal end of the rigid hollow needle inserter 90', the flared coil section 64 is configured to automatically recoil radially outward against a compressed state (e.g., by self-expansion) and contact the ocular tissue of the needle path, mechanically anchoring or fixing the device in the deployed position in the intraocular, thereby preventing unwanted movement of the device into the anterior chamber of the eye. In this configuration, the spring anchor 62 can function as a mechanism to support the umbrella-shaped sheath 111, which prevents unwanted periannular leakage of aqueous humor around the outer annular surface of the tube 61 of the device 60' when opened in the needle path. Deployment can be performed as part of an extraocular procedure in which the needle tip 91 of the hollow needle inserter 90' penetrates the ocular tissue to the anterior chamber for intraocular deployment of the device. Once the device 60' is implanted intraocularly using an extraocular procedure, the distal end (e.g., end 65b) of the drainage tube 61 of the device 60' is positioned in the anterior chamber of the eye, and the proximal end (e.g., end 65a) of the drainage tube 61 is positioned in a drainage space such as the conjunctiva and Tenon's capsule or the suprachoroidal space. Alternatively, deployment can be performed as part of an intraocular procedure in which the distal end of the hollow needle inserter 90' is first positioned medially into the anterior chamber via a corneal incision, and then penetrates the ocular tissue to a drainage space such as the conjunctiva and Tenon's capsule or the suprachoroidal space. Once the device 60' is implanted in the eye using an intraocular procedure, the distal end (e.g., end 65b) of the drainage tube 61 of the device 60' is positioned in a drainage space such as the conjunctiva and Tenon's capsule or the suprachoroidal space, while the proximal end (e.g., end 65a) of the drainage tube 61 is positioned medially within the anterior chamber of the eye.

[0036] In other embodiments, the spring anchors 72, 82 of the apparatus in Figures 7 and 8 are fitted with thin sheaths similar to the sheath 111 in Figure 12. In this configuration, one or more portions of the sheath can be bonded or joined to the outer surface of the apparatus tube to form a seal around the entire circumference of the tube, while another portion of the sheath is configured to expand along the entire circumference of the tube with the apparatus's flare coil area. When the flare coil area is expanded, the sheath can come into contact with the surrounding tissue so that the sheath prevents flow or leakage of aqueous humor around the annular circumference. The sheath is made from a flexible, porous or non-porous elastomer polymer fabric such as stretched polytetrafluoroethylene (xPTFE), Dacron®, polyurethane, SIBS, and fabrics made from these equivalents. The sheath may be similar to a sheath used in a stent graft or lumen graft. In these embodiments, the spring anchor can function as a mechanism to support an expandable sheath that prevents flow or leakage of aqueous humor around the annular circumference when opened in the needle channel.

[0037] A hollow needle inserter as described herein can be used to deploy the glaucoma drainage device shown in Figures 3, 4, 5, 7, and 8, in the same manner as described above for Figures 9, 10, 12, and 13.

[0038] Figure 17 shows an embodiment of a lumen-less glaucoma drainage device 1000 configured to be embedded in the suprachoroidal space of the eye. In the illustrated embodiment, the device 1000 consists of a lumen-less, elongated body 1001 having opposing ends 1003 and 1005. The lumen-less body 1001 is configured to allow aqueous humor to diffuse from the anterior chamber into the suprachoroidal space of the eye.

[0039] In the illustrated embodiment, the lumenless body 1001 has one or more outer surfaces 1007 defining at least one open groove or channel 1009 extending parallel to the longitudinal axis AA of the elongated body 1001 between a point at or near the end 1003 and a point at or near the end 1005. The groove or channel 1009 allows aqueous humor to flow along the outer surface of the body 1001 and diffuse from the anterior chamber into the suprachoroidal space of the eye. In an alternative embodiment (not shown), the lumenless elongated body 1001 is formed of a porous material that allows aqueous humor to flow through the elongated body into the elongated body and drain the aqueous humor from the anterior chamber into the suprachoroidal space of the eye.

[0040] The device 1000 further includes an anchor 1011 formed by wire sections 1013A and 1013B that function as an anchor or wire, similar to the embodiment in Figure 3 as described herein. The wire sections 1013A and 1013B are positioned on one side of the body 1001 in the central portion of the body 1001 between opposing ends 1003 and 1005. As shown, the wire sections 1013A and 1013B can be bent radially away from the longitudinal axis of the body 1001 and toward the opposing ends 1003 and 1005. When the device 1000 is loaded inside the distal end of a hollow needle inserter, the wire sections 1013A and 1013B are held in a compressed state. With the distal end of the hollow needle inserter positioned in the needle pathway and the wire sections 1013A and 1013B positioned within the needle pathway, the glaucoma drainage device 1000 can be deployed from the distal end of the hollow needle inserter. In this configuration, the wire sections 1013A and 1013B automatically recoil from a compressed state (e.g., by self-expansion) and expand radially outward, contacting or catching on the ocular tissue of the needle pathway and mechanically securing or fixing the device 1000 in its deployed position within the eye, thereby preventing unwanted movement of the device into the anterior chamber of the eye. In embodiments, the wire sections 1013A and 1013B are formed from wires having a wire diameter in the range of 0.001 inches to 0.008 inches, preferably between 0.002 inches and 0.004 inches. The wire sections 1013A and 1013B are either two separate wires or a single continuous wire. In an alternative embodiment, the device 1000 may use only one wire (i.e., 1013A or 1013B) extending from the main body 1001. The device 1000 (including wire sections 1013A and / or 1013B) is housed within the distal end of a hollow needle inserter (as in Figures 9 and 10) and deployed from there for implantation of the device into the eye. Deployment can be performed as part of an intraocular procedure in which the distal end of the hollow needle inserter is first positioned inside the anterior chamber of the eye via a corneal incision and then penetrates the ocular tissue to the suprachoroidal space (drainage space) for deployment of the device 1000 within the eye.When the device 1000 is implanted intraocularly using an intraocular procedure, the distal end of the main body 1001 (e.g., end 1005) is positioned in the suprachoroidal space, i.e., the drainage space, and the proximal end of the main body 1001 (e.g., end 1003) is positioned medially within the anterior chamber of the eye. Alternatively, deployment can be performed as part of an extraocular procedure in which the distal end of a hollow needle inserter penetrates the ocular tissue into the anterior chamber for intraocular deployment of the device 1000. When the device 1000 is implanted intraocularly using an extraocular procedure, the distal end of the main body 1001 (e.g., end 1005) is positioned within the anterior chamber of the eye, and the proximal end of the main body 1001 (e.g., end 1003) is positioned in the suprachoroidal space, i.e., the drainage space. Alternatively, deployment can be performed as part of an intraocular procedure in which the distal end of a hollow needle inserter is first positioned inside the anterior chamber of the eye via a corneal incision, and then penetrates the ocular tissue to the suprachoroidal space, i.e., the drainage space.

[0041] Figure 18 shows another embodiment of a lumen-less glaucoma drainage device 1000' configured to be implanted in the suprachoroidal space of the eye. The body of device 1000' is equivalent to the body 1001 of device 1000 in Figure 17. Device 1000' further includes an anchor 1011' formed by wire sections 1013A, 1013B, 1013C, 1013D that function as anchors or wires similar to the embodiment in Figure 3, as described herein. The wire sections 1013A, 1013B are positioned on one side of the body 1001 in the central portion of the body 1001 between opposing ends 1003, 1005. As shown, the wire sections 1013A, 1013B can be bent radially away from the longitudinal axis of the body 1001 and toward the opposing ends 1003, 1005. The wire sections 1013C and 1013D are positioned in the central portion of the main body 1001 between opposing ends 1003 and 1005, on the opposite side of the main body 1001 (relative to wire sections 1013A and 1013B). As shown in the figure, the wire sections 1013C and 1013D can be bent radially away from the longitudinal axis of the main body 1001 and toward opposing ends 1003 and 1005.

[0042] When the device 1000' is loaded inside the distal end of the hollow needle inserter, the wire sections 1013A, 1013B, 1013C, and 1013D are held in a compressed state. With the distal end of the hollow needle inserter positioned in the needle pathway and the wire sections 1013A, 1013B, 1013C, and 1013D positioned within the needle pathway, the glaucoma drainage device 1000' can be deployed from the distal end of the hollow needle inserter. In this configuration, the wire sections 1013A, 1013B, 1013C, and 1013D automatically recoil from the compressed state (e.g., by self-expansion) and expand radially outward, contacting or catching on the ocular tissue of the needle pathway and mechanically securing or fixing the device 1000' in its deployed position within the eye, thereby preventing unwanted movement of the device into the anterior chamber of the eye. In the embodiment, the wire sections 1013A, 1013B, 1013C, and 1013D are formed from wires having a wire diameter in the range of 0.001 inches to 0.008 inches, preferably between 0.002 inches and 0.004 inches. The wire sections 1013A and 1013B are two separate wires or one continuous wire. Similarly, the wire sections 1013C and 1013D are two separate wires or one continuous wire. As with the embodiment of Figure 17 described above, the device 1000' (including the wire sections 1013A, 1013B, 1013C, and 1013D) is housed within the distal end of a hollow needle inserter and deployed from there for implantation of the device into the eye.

[0043] Figure 19 shows yet another embodiment of the lumenless glaucoma drainage device 1000” configured to be implanted in the suprachoroidal space of the eye. The body of the device 1000” is the same as the body 1001 of the device 1000 in Figures 17 and 18. The device 1000” further includes an anchor 1011” formed by wire portions 1013A', 1013B' that function as an anchor or wire, similar to the embodiment in Figure 3 as described herein. The wire portions 1013A', 1013B' are located on one side of the body 1001 in the central portion of the body 1001 between opposing ends 1003, 1005. As shown, the wire portions 1013A', 1013B' are formed by half-loops of wire that are radially away from the longitudinal axis of the body 1001 and curve toward the opposing ends 1003, 1005.

[0044] When the device 1000" is loaded inside the distal end of the hollow needle inserter, the wire sections 1013A' and 1013B' are held in a compressed state. With the distal end of the hollow needle inserter positioned in the needle pathway and the wire sections 1013A' and 1013B' positioned within the needle pathway, the glaucoma drainage device 1000" can be deployed from the distal end of the hollow needle inserter. In this configuration, the wire sections 1013A' and 1013B' can automatically recoil from the compressed state (e.g., by self-expansion) and expand radially outward, and the ends of the half-loops of the wire sections 1013A' and 1013B' can contact the ocular tissue of the needle pathway, mechanically securing or fixing the device 1000' in the deployed position within the eye, thereby preventing unwanted movement of the device into the anterior chamber of the eye. The half-loop ends of the wire sections 1013A' and 1013B' are designed to minimize or reduce damage to ocular tissue when deployed into the needle path during implantation (compared to the pointed ends of the anchor wire sections in Figures 17 and 18). In embodiments, the wire sections 1013A' and 1013B' are formed from wires having a wire diameter ranging from 0.001 inches to 0.008 inches, preferably between 0.002 inches and 0.004 inches. The wire sections 1013A' and 1013B' are either two separate wires or a single continuous wire. Similar to the embodiment in Figure 17 described above, the device 1000' (including the wire sections 1013A' and 1013B') is housed within the distal end of a hollow needle inserter and deployed from there for implantation of the device into the eye.

[0045] In this embodiment, the body 1001 may have a shallowly curved I-beam cross-section as shown in Figures 17 to 19, which defines two grooves 1009 extending parallel to each other on opposing sides of the body 1001 and parallel to the longitudinal axis of the body 1001. Alternatively, other cross-sectional shapes (such as a flat I-beam cross-section) or other suitable shapes may be used for the body 1001.

[0046] In other embodiments, instead of (or in combination with) anchors 1011, 1011', or 1011” in the embodiments of Figures 17 to 19, any one of the anchors or wires shown in Figures 4 to 8 and described herein may be used. Other suitable anchor or wire designs may also be used.

[0047] Glaucoma drainage devices as described herein are made from flexible, bioinert polymer materials. Exemplary flexible polymer materials include polyurethane, polyisobutylene, polyisobutylene urethane, poly(styrene-blocked isobutylene-blocked styrene) ("SIBS"), silicone rubber, PTFE, polyester, polysulfone, plioimide, and other materials considered bioinert in the body. SIBS is a preferred material. The lumen diameter of the device is in the range of 40 to 100 micrometers, preferably 60 to 80 micrometers. The outer diameter of the device is in the range of 120 to 500 micrometers, preferably 150 to 300 micrometers. The length of the device is in the range of 4 mm to 25 mm, preferably 5 mm to 9 mm. The needle gauge of the rigid, hollow needle inserter used to deploy the device is in the range of 20 to 30 gauge, preferably 23 to 27 gauge. A device can be installed using an intraocular or extraocular approach to drain aqueous humor from the anterior chamber into a drainage space such as a bleb or suprachoroidal space formed beneath the conjunctiva and Tenon's capsule.

[0048] This specification has described and illustrated several embodiments of glaucoma drainage devices and related systems, as well as methods for treating glaucoma. Furthermore, while certain configurations have been disclosed with respect to glaucoma drainage devices, it will be understood that other configurations may also be used. Accordingly, it will be understood by those skilled in the art that further other modifications may be made to the provided invention without departing from the spirit and scope of the claims.

Claims

1. A long, slender body designed to drain aqueous humor from the anterior chamber of the eye, At least one expandable anchor or wire extending radially outward beyond the main body and configured to fix the main body within the eye, A glaucoma drainage device equipped with [specific features / features].

2. The glaucoma drainage device according to claim 1, wherein the at least one expandable anchor or wire is configured to automatically self-expand and move radially away from the body in order to fix the body in the eye.

3. The glaucoma drainage device according to claim 1, wherein the at least one expandable anchor or wire comprises at least one wire portion extending radially outward beyond the main body.

4. The glaucoma drainage device according to claim 3, wherein at least one wire portion has a wire diameter in the range of 0.0254 mm to 0.2032 mm (preferably between 0.0508 mm and 0.1016 mm).

5. The glaucoma drainage device according to claim 2, wherein the at least one expandable anchor or wire comprises at least one smaller diameter coil section and at least one larger diameter coil section, the at least one smaller diameter coil section being wrapped around the elongated body and mechanically secured to the elongated body, and the at least one larger diameter coil section being configured to automatically self-expand radially away from the body in order to fix the body in the eye.

6. The glaucoma drainage device according to claim 5, wherein the at least one smaller diameter coil area and the at least one larger diameter coil area are formed by coiled wires having a wire diameter in the range of 0.0254 mm to 0.2032 mm (preferably between 0.0508 mm and 0.1016 mm).

7. The glaucoma drainage device according to claim 1, wherein the at least one expandable anchor or wire further comprises a sheath surrounding a portion of the expandable anchor or wire, the sheath being configured to expand radially together with the portion of the expandable anchor or wire.

8. The glaucoma drainage device according to claim 7, wherein the radial expansion of the sheath is configured to block the flow of aqueous humor around the annular circumference of the main body.

9. The glaucoma drainage device according to claim 7, wherein the sheath is made of a flexible elastomer polymer.

10. The glaucoma drainage device according to claim 1, wherein the at least one expandable anchor or wire is made of metal.

11. The glaucoma drainage device according to claim 10, wherein the metal is selected from the group including nickel-titanium alloy, cobalt-chromium-nickel alloy, MP35N, titanium, stainless steel, tantalum, and equivalents thereof.

12. The glaucoma drainage device according to claim 1, wherein the elongated body is formed from a flexible polymer material.

13. The glaucoma drainage device according to claim 1, wherein the at least one expandable anchor or wire is configured to secure the main body to a needle passage connected to the anterior chamber of the eye.

14. The glaucoma drainage device according to claim 1, wherein the elongated body has a lumen extending through the body.

15. The glaucoma drainage device according to claim 1, wherein the elongated body does not have a lumen and has at least one channel defined by the outer surface of the body or the porous material of the body.

16. The glaucoma drainage device according to claim 1, A rigid needle inserter having a distal end with a distal tip for puncturing tissue, wherein the distal end releasably houses the glaucoma drainage device while at least a portion of the anchor or wire is held in a compressed state. Includes, A glaucoma drainage system wherein at least a portion of the wire or anchor of the glaucoma drainage device is configured to automatically expand from the compressed state when deployed from the distal end of the rigid needle inserter, thereby mechanically securing or fixing the glaucoma drainage device within the eye.

17. The glaucoma drainage system according to claim 16, wherein the rigid needle inserter includes a rod configured to push the body of the glaucoma drainage device or the wire or anchor, thereby deploying the glaucoma drainage device from the distal end of the rigid needle inserter.

18. A method for treating glaucoma in the human eye, A step of inserting a rigid needle inserter through ocular tissue to form a needle pathway connected to the anterior chamber, wherein the needle inserter has a distal end having a distal tip for puncturing tissue, and the distal end releasably houses the glaucoma drainage device according to claim 1, with an expandable anchor or portion of a wire held in a compressed state; The steps include deploying the glaucoma drainage device from the distal end of the needle inserter with the anchor or a portion of the wire positioned in the needle path, thereby enabling the expandable anchor or portion of the wire to automatically expand and mechanically secure or fix the glaucoma drainage device to the needle path; Methods that include...

19. The method according to claim 18, wherein the at least one expandable anchor or wire further comprises a sheath configured to expand radially together with a portion of the expandable anchor, the radial expansion of the sheath configured to block the annular flow of aqueous humor around the body of the glaucoma drainage device.

20. The method according to claim 18, wherein the needle passage is further connected to a drainage space, enabling the glaucoma drainage device to drain aqueous humor from the anterior chamber of the eye into the drainage space.

21. The method according to claim 20, wherein the drainage space is located below the conjunctiva and Tenon's capsule of the eye, or the drainage space is located in the suprachoroidal space.

22. The method according to claim 18, wherein the rigid needle inserter includes a rod configured to push the body of the glaucoma drainage device or the wire or anchor, thereby deploying the glaucoma drainage device from the distal end of the rigid needle inserter.

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