A device for adjusting intraocular pressure.

Abstract

The present invention provides implantable devices for controlling fluid outflow from the anterior chamber of the eye, kits containing them, and methods for using them in the treatment of glaucoma.

Description

Background Art

[0004] ,

[0003] ,

[0001] Background of the Invention Glaucoma is a neuropathy characterized by acquired atrophy of the optic nerve and loss of retinal ganglion cells and their axons. Among other factors, increased intraocular pressure contributes to progressive irreversible nerve damage and visual field loss, which may lead to complete blindness.

[0002] Worldwide, glaucoma is the second leading cause of blindness. Glaucoma affects 1 in 20 people under 50 years of age and 1 in 10 people over 80 years of age. If the disease is detected early enough, it is possible to stop the onset of glaucoma or at least slow its progression through medication and surgical means.

[0003] Glaucoma is associated with increased pressure (intraocular pressure) of the fluid (aqueous humor) in the eye's anterior chamber. There are many different subtypes of glaucoma, but they can all be considered as one type of neuropathy. Increased intraocular pressure is a significant risk factor for developing glaucoma (above 21 mmHg or 2.8 kPa). Nerve damage can be caused by an increase in intraocular pressure, but the magnitude of the increased pressure that can cause nerve damage varies from person to person, i.e., in certain individuals, a relatively small increase in intraocular pressure may result in irreversible nerve damage, while others may have high intraocular pressure for a long time (i.e., months or years) before developing nerve damage. Untreated glaucoma results in permanent damage to the optic nerve fibers and progressive visual field loss, which can lead to complete blindness.

[0004] Glaucoma can be broadly divided into two main types: open-angle glaucoma (OAG) and closed-angle glaucoma (CAG). CAG can appear suddenly, causing unbearable pain, or it can develop insidiously with only slight discomfort. In the acute form, vision loss can progress rapidly, but discomfort often leads patients to seek medical help before permanent damage occurs. OAG and chronic closed-angle glaucoma tend to progress at a slower rate, and patients may not realize they have lost vision until the disease has progressed significantly.

[0005] Intraocular pressure is maintained by the dynamic equilibrium of fluid production and outflow. The iris divides the anterior part of the eye into the anterior and posterior chambers, which communicate through the pupil. Aqueous humor, produced by the ciliary body, fills the posterior chamber, flows into the anterior chamber through the pupil, and exits the eye through the filter of the trabecular meshwork, which is connective tissue at the corner between the iris and the cornea. The aqueous humor passes through the trabecular meshwork into Schlemm's canal and the episcleral venous system. Elevated intraocular pressure is caused by obstruction of outflow. In OAG disease, the obstruction is present at a microscopic level in the trabecular meshwork. In CAG, the iris physically clogs the trabecular meshwork, either due to anatomical changes that lead to pupillary blockage and obstruction of aqueous humor flow into the anterior chamber, or due to adhesion formation between the iris and the trabecular meshwork.

[0006] There are numerous known devices intended to control intraocular pressure in glaucoma-affected eyes.

[0007] U.S. Patent No. 5300020 discloses a surgically implantable device for controlled drainage of an aqueous fluid from the anterior chamber of the eye to the peripheral subconjunctival space for the relief of glaucoma-related excess intraocular pressure. The porous material in the device of U.S. Patent No. 5300020 has been shown to be biodegradable, so that eventually, this material will decompose and exit the hollow tube connecting the peripheral subconjunctival space and the anterior chamber. The purpose and effect of the biodegradability of the porous material inside the device is to avoid premature hypotension. However, this device may not improve surgical outcomes because the fluid flowing into the peripheral subconjunctival space can regenerate intraocular pressure in a short period of time. Over time, scar tissue will develop in a certain percentage of patients, which will clog the device and the conjunctival filtration bleb.

[0008] U.S. Patent No. 5,743,868 discloses a single pressure-regulating corneal implant device for use in controlling intraocular pressure. This implant, having a luminal conduit and a porous core material positioned within the lumen, allows for the drainage of aqueous humor from the anterior chamber of the eye. The conduit is stretched to extend into the anterior chamber from the optical surface of the eye, where it is substantially washed away through the corneal matrix. This is an open-system device, thus allowing for the drainage of fluid into the eye, which may contain infectious material. The cornea would almost certainly reject the device as foreign material (as is typical when foreign material is implanted in the cornea) and would also distort the optical surface of the cornea, thereby causing optical aberrations in patients treated with this device.

[0009] U.S. Patent No. 4,946,436 relates to a porous device for implantation in the scleral tissue of the eye to relieve intraocular pressure in glaucoma, and to a method for surgically implanting the device. It should be noted that such a device is intended to be implanted within the sclera, and therefore fluid can only be removed into the accompanying space.

[0010] The device described in U.S. Patent No. 4,946,436 was not found to improve surgical outcomes compared to trabeculectomy for treating glaucoma. [Overview of the project]

[0011] Summary of the Invention The present invention provides an implantable device for controlling fluid outflow from the anterior chamber of an eye, comprising: a tubular component comprising at least one tube, the tubular component having an elongated body having a first end that is positionable in the anterior chamber of the eye and a second end that is positionable in the extraocular space, and having an entry point through the sclera of the eye, wherein the tubular component is configured to provide a fluid passage for draining fluid entering the first end of the tubular component from the anterior chamber to the extraocular space via the second end, the tubular component being formed from at least one non-porous, non-degradable polymer; and at least one patch component that is positionable under the conjunctiva of the eye, formed from at least one porous, non-degradable polymer.

[0012] The present invention provides an implantable device for the treatment of glaucoma, comprising: a tubular component comprising at least one tube, the tubular component having an elongated body having a first end that can be positioned in the anterior chamber of the eye and a second end that can be positioned in the extraocular space, and having an entry point through the sclera of the eye, the tubular component being configured to provide a fluid passage for draining fluid that enters the first end of the tubular component from the anterior chamber to the extraocular space via the second end, the tubular component being formed from at least one non-porous, non-degradable polymer; and at least one patch component that can be positioned under the conjunctiva of the eye, formed from at least one porous, non-degradable polymer.

[0013] The device of the present invention enables the drainage of aqueous humor from the eye into the extraocular space (such as the space within the posterior bulb / posterior orbit / myoconus). The extraocular space has a positive pressure of approximately 400-800 Pa (approximately 3-6 mmHg). The aforementioned conventional solutions drain the eye into the subconjunctival space, which has negative pressure, by utilizing the hydrodynamics of the suprascleral venous plexus that drains the anterior part of the eye (Enz, TJ; Tschopp, M. Assessment of Orbital Compartment Pressure: A Comprehensive Review. Diagnostics 2022, 12, 1481. https: / / doi.org / 10.3390 / diagnostics12061481).

[0014] The tubular component described above has resistance, thus creating a low threshold below which the extraocular pressure (intraocular pressure) cannot theoretically decrease. This is achieved by manipulating the length and inner diameter of the tubular component according to the Hagen-Poiseuille equation (which gives a pressure drop in a laminar, incompressible Newtonian fluid flowing through a long cylindrical pipe of a constant cross-sectional area).

[0015] The above patch components enable integration with the surrounding subconjunctival tissue. The above patch components conceal the tubular component from the conjunctiva that is covering it, thereby accelerating integration. Since the above patch is non-degradable, this allows the patch to form with a thickness thinner than the thickness of the tissue. Furthermore, the above patch components fix the entire tubular component in a specific location, preventing migration of the device of the present invention, either internally or externally. In some embodiments, the above patch components further include an extension that conceals the scleral penetration point, which prevents leakage around the tubular component post-scleral surgery and early in the implantation procedure, which in other solutions may result in severe hypotension immediately after the implantation procedure and during the initial follow-up period.

[0016] The present invention further provides a kit comprising: a tubular component comprising at least one tube, the tubular component having an elongated body having a first end that can be positioned in the anterior chamber of the eye and a second end that can be positioned in the extraocular space, and having an entry point through the sclera of the eye, the tubular component being configured to provide a fluid passage for draining fluid that enters the first end of the tubular component from the anterior chamber to the extraocular space via the second end, the tubular component being formed from at least one non-porous, non-degradable polymer; at least one patch component that can be positioned under the conjunctiva of the eye, formed from at least one porous, non-degradable polymer; and instructions for use of the kit.

[0017] The present invention further provides the device of the present invention as disclosed above and below this specification; implanting the device in the eye of a target such that the tubular component passes through an entry point and through the sclera of the eye of a target, and the first end of the tubular component is positioned in the anterior chamber of the eye and the second end of the tubular component is positioned in the extraocular space; and providing a method for controlling fluid outflow from the anterior chamber of the eye, comprising positioning the patch component subconjunctivally, on the tubular component, and covering the scleral entry point.

[0018] The present invention further provides the device of the present invention as disclosed above and below this specification; and implants the device into the eye of a target such that the tubular component passes through an entry point and through the sclera of the eye of a target, the first end of the tubular component is positioned in the anterior chamber of the eye and the second end of the tubular component is positioned in the extraocular space; and provides a method for treating glaucoma, comprising positioning the patch component subconjunctivally of the eye, on the tubular component, and covering the scleral entry point.

[0019] The subject matter considered to be part of the present invention is pointed out and explicitly asserted in particular in the concluding section of this specification. However, the present invention, with respect to both its mechanisms and methods of operation, along with its objectives, features and advantages, will be best understood when read in conjunction with the accompanying drawings and with reference to the detailed description below. [Brief explanation of the drawing]

[0020] [Figure 1] Figure 1 shows an embodiment of the device of the present invention. [Figure 2] Figure 2 shows an embodiment of the device of the present invention. [Modes for carrying out the invention]

[0021] For the sake of brevity and clarity of the illustrations, the elements shown in the figures are not necessarily depicted in exact proportions. For example, the dimensions of some elements may be exaggerated compared to others for clarity. Furthermore, where deemed appropriate, reference numbers may be repeated in multiple figures to indicate corresponding or similar elements.

[0022] Numerous specific details are provided in the following detailed description to provide a thorough understanding of the invention. However, it will be understood by those skilled in the art that the invention can be practiced without using these specific details. In other examples, well-known methods, procedures, and components are not described in detail so as not to obscure the invention.

[0023] The present invention provides a transplantable device for controlling liquid outflow from the anterior chamber of the eye and for treating glaucoma, comprising a tubular component including at least one tube, the tubular component having a first end portion that can be positioned in the anterior chamber of the eye and a second end portion that can be positioned in the extraocular space, and having an elongated body with an entry point through the sclera of the eye, the tubular component being configured to provide a fluid passage for draining fluid that enters the first end portion of the tubular component from the anterior chamber to the extraocular space through the second end portion, the tubular component being formed from at least a non-porous non-degradable polymer, and at least one patch component that can be positioned under the conjunctiva of the eye and is formed from at least one porous non-degradable polymer.

[0024] In some embodiments, the extraocular space is selected from the retrobulbar space of the eye, the posterior orbital space, and the space within the muscular cone.

[0025] In some embodiments, the at least one non-porous non-degradable polymer is selected from polyurethane, polycarbonate, poly(ethylene-co-vinyl acetate) vinyl acetate, poly(methyl methacrylate), poly(propylene carbonate), poly(vinylidene fluoride), polyacrylonitrile, polycarbomethylsilane, polylactic acid, polystyrene, polyvinylpyrrolidone, polyvinyl alcohol (PVA), polyethylene oxide (PEO), polyurethane, polyvinyl chloride (PVC), hyaluronic acid (HA), polyhydroxybutyric acid and its copolymers, nylon 11, cellulose acetate, poly(3-hydroxybutyric acid-co-3-hydroxyvaleric acid), poly(DL-lactide), polycaprolactone, and poly(L-lactide), or any combination thereof.

[0026] In some embodiments, the tubular component has a length of at least 10 mm.

[0027] In some embodiments, the tubular component has a length between about 10 mm and about 100 mm. In some embodiments, the tubular component has a length of about 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75, 80, 85, 90, 95, 100 mm.

[0028] In some embodiments, the tubular component has an inner diameter of at least 50 microns.

[0029] In some embodiments, the tubular component has an inner diameter between about 50 microns and about 150 microns. In some embodiments, the tubular component has an inner diameter of about 50, 55, 60, 65, 70, 75, 80, 85, 90, 95, 100, 110, 120, 130, 140, 150 microns.

[0030] In some embodiments, the tubular component has a length and inner diameter according to the Hagen - Poiseuille law to provide a controlled resistance to the outflow of liquid from the anterior chamber of the eye to the extraocular space.

[0031] In some embodiments, the at least one patch component is positioned over the tubular component. In other embodiments, the at least one patch component is positioned over the tubular component and physically attached to the component. In other embodiments, the at least one patch component further includes at least one suture hole.

[0032] In some embodiments, the at least one patch component has a thickness of less than 100 microns.

[0033] In some embodiments, the at least one patch component has a thickness between about 10 and about 100 microns. In some embodiments, the at least one patch component has a thickness of about 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75, 80, 85, 90, 95, and 100 microns.

[0034] In some embodiments, the above-mentioned at least one porous non-degradable polymer is selected from polycarbonate, poly-L-lactic acid (PLLA), poly(DL-lactide-co-caprolactone), poly(ethylene-co-vinyl acetate)vinyl acetate, poly(methyl methacrylate), poly(propylene carbonate), poly(vinylidene fluoride), polyacrylonitrile, polycarbomethylsilane, polylactic acid, polystyrene, polyvinylpyrrolidone, polyvinyl alcohol (PVA), polyethylene oxide (PEO), polyurethane, polyvinyl chloride (PVC), hyaluronic acid (HA), polyhydroxybutyric acid and its copolymers, nylon 11, cellulose acetate, poly(3-hydroxybutyric acid-co-3-hydroxyvaleric acid), poly(DL-lactide), polycaprolactone, and poly(L-lactide), or any combination thereof.

[0035] In some embodiments, the porous, non-degradable polymer is a nonwoven fabric.

[0036] In some embodiments, the porous, non-degradable polymer includes nanofibers.

[0037] In some embodiments, the porous, non-degradable polymer is electrospun.

[0038] Electrospun fibers are typically several orders of magnitude smaller than those produced using conventional spinning techniques. By optimizing parameters such as i) the polarity and surface tension of the solvent, the molecular weight and conformation of the polymer chains, and the intrinsic properties of the solution including its viscosity, elasticity, and electrical conductivity, and ii) operating conditions such as the electric field strength, the distance between the spinneret and collector, and the solution supply rate, electrospinning can produce fibers as thin as tens of nanometers in diameter. Additional parameters that affect the properties of electrospun fibers include the molecular weight, molecular weight distribution and structure (branched, linear, etc.) of the polymer, solution properties (viscosity, conductivity, and surface tension), potential, flow rate and concentration, the distance between the capillary and collection screen, ambient parameters (temperature, humidity, and airflow velocity in the chamber), and the movement of the target screen (collector). The production of highly porous fibers may be achieved by electrospinning a jet directly into a cryogenic solution. Clearly defined pores were formed on the surface of each fiber as a result of temperature-induced phase separation between the polymer and the solvent, and evaporation of the solvent under freeze-drying conditions.

[0039] Multiple approaches have been developed to organize electrospun fibers into aligned arrangements. For example, electrospun fibers can be aligned into a uniaxial arrangement by replacing a single collector with a pair of conductive substrates separated by voids. In this case, the nanofibers tend to extend across voids oriented perpendicular to the edges of the electrodes. It has also been shown that electrode pairs can be patterned on insulating substrates such as quartz or polystyrene, so that uniaxially aligned fibers can be layered into a 3D lattice. It is also possible to generate more complex configurations of well-aligned nanofibers by controlling the electrode pattern and / or order to apply high voltages.

[0040] Electrospun nanofibers can also be directly attached to various objects to obtain nanofiber-based structures with well-defined and controllable shapes. In addition, aligned or randomly oriented nanofiber films can be manually processed into various types of structures after electrospinning, for example, by winding the fiber film to create tubes, or by drilling holes in the fiber film to create discs with controllable diameters.

[0041] The present invention relates to any electrospinning techniques known in the art, including Electrospinning, J. Stanger, N. Tucker, and M. Staiger, I-Smithers Rapra publishing (UK), An Introduction to Electrospinning and Nanofibers, S. Ramakrishna, K. Fujihara, WE Teo, World Scientific Publishing Co. Pte Ltd (Jun 2005), and Electrospinning of micro- and nanofibers: fundamentals and applications in separation and filtration processes, Y. Fillatov, A. Budyka, and V. Kirichenko (Trans. D. Letterman), Begell House Inc., New York, USA, 2007, all of which are incorporated herein by reference as a whole.

[0042] Appropriate electrospinning techniques are disclosed, for example, in International Publications WO2002 / 049535, WO2002 / 049536, WO2002 / 049536, WO2002 / 049678, WO2002 / 074189, WO2002 / 074190, WO2002 / 074191, WO2005 / 032400, and WO2005 / 065578, the contents of which are incorporated herein by reference. While electrospinning techniques are described with particular emphasis according to the currently preferred embodiments of the present invention, it should be understood that there is no intention to limit the scope of the present invention to electrospinning techniques. Other representative spinning techniques suitable for embodiments of the present invention include, but are not limited to, wet spinning, dry spinning, gel spinning, dispersion spinning, reactive spinning, or tack spinning. Such and other spinning techniques are publicly known in the art and are disclosed, for example, in U.S. Patents No. 3,737,508, No. 3,950,478, No. 3,996,321, No. 4,189,336, No. 4,402,900, No. 4,421,707, No. 4,431,602, No. 4,557,732, No. 4,643,657, No. 4,804,511, No. 5,002,474, No. 5,122,329, No. 5,387,387, No. 5,667,743, No. 6,248,273 and No. 6,252,031, the contents of which are incorporated herein by reference.

[0043] In some embodiments, the porous, non-degradable polymer has pores smaller than 5 microns.

[0044] In some embodiments, the porous non-degradable polymer has pores between about 0.01 microns and about 5 microns. In some embodiments, the porous non-degradable polymer has pores of about 0.01, 0.05, 0.1, 0.15, 0.20, 0.25, 0.30, 0.35, 0.40, 0.45, 0.50, 0.55, 0.60, 0.65, 0.70, 0.75, 0.80, 0.85, 0.90, 0.95, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, and 5 microns.

[0045] In some embodiments, the at least one patch component further comprises at least one pharmaceutically active agent.

[0046] In some embodiments, the at least one patch component further comprises at least one pharmaceutically active agent selected from antifibrotic agents, anticoagulants, antithrombotic agents, antibiotics, anti-inflammatory agents, biodegradable materials, antihypertensive agents, anti-angiogenic agents, or any combination thereof.

[0047] The present invention further provides a kit comprising: a tubular component comprising at least one tube, the tubular component having an elongated body having a first end that can be positioned in the anterior chamber of the eye and a second end that can be positioned in extraocular space, and having an entry point through the sclera of the eye, the tubular component being configured to provide a fluid passage for draining fluid that enters the first end of the tubular component from the anterior chamber to extraocular space via the second end, the tubular component being formed from at least one non-porous, non-degradable polymer; and at least one patch component that can be positioned under the conjunctiva of the eye, formed from at least one porous, non-degradable polymer; and instructions for use of the kit.

[0048] The present invention further provides the device of the present invention as disclosed above and below this specification; and implants the device into the eye of a target such that the tubular component passes through an entry point and through the sclera of the eye of a target, and the first end of the tubular component is positioned in the anterior chamber of the eye and the second end of the tubular component is positioned in the extraocular space; and provides a method for controlling fluid outflow from the anterior chamber of the eye and for treating glaucoma, comprising positioning the patch component subconjunctivally, on the tubular component, and covering the scleral entry point.

[0049] In another embodiment, the present invention provides a surgical method for implanting the device of the present invention into an eye of a subject, the method comprising: performing a local peritomy including removing the conjunctiva and Tenon's capsule; creating a transscleral tubular channel, wherein in some embodiments the tubular channel is created using a sharp cylindrical knife; positioning the device within the tubular channel, wherein at least one end of the device is directed (or positioned) toward the anterior chamber and the opposite end is directed (or positioned) toward the extraorbital space; covering the entry point into the sclera of the eye with the patch component, and in some embodiments suturing the patch.

[0050] Figures 1 and 2 illustrate embodiments of the implantable device for controlling fluid outflow from the anterior chamber of the eye according to the present invention.

[0051] Figure 1 shows a device (100) comprising: a tubular component (101) including at least one tube, the tubular component having an elongated body having a first end (102) that can be positioned in the anterior chamber of the eye and a second end (103) that can be positioned in the extraocular space, and having an entry point through the sclera of the eye, the tubular component being configured to provide a fluid passage for draining fluid that has entered the first end of the tubular component from the anterior chamber to the extraocular space via the second end, the tubular component being formed from at least one non-porous, non-degradable polymer; and at least one patch component (104) that can be positioned under the conjunctiva of the eye, formed from at least one porous, non-degradable polymer.

[0052] Figure 2 shows another figure (200) of the device of the present invention, comprising: a tubular component (201) including at least one tube, the tubular component having an elongated body having a first end (202) that can be positioned in the anterior chamber of the eye and a second end (203) that can be positioned in the extraocular space, and having an entry point through the sclera of the eye, the tubular component being configured to provide a fluid passage for draining fluid that has entered the first end of the tubular component from the anterior chamber to the extraocular space via the second end, the tubular component being formed from at least one non-porous, non-degradable polymer; and at least one patch component (204) that can be positioned under the conjunctiva of the eye, formed from at least one porous, non-degradable polymer.

[0053] While certain features of the present invention are illustrated and described herein, many modifications, substitutions, alterations, and equivalents will be apparent to those skilled in the art. Therefore, it should be understood that the appended claims are intended to encompass all such modifications and alterations that fall within the true spirit of the present invention.

Claims

1. An implantable device for controlling fluid outflow from the anterior chamber of the eye, - A tubular component comprising at least one tube, having an elongated body having a first end that can be positioned in the anterior chamber of the eye and a second end that can be positioned in the extraocular space, and having an entry point through the sclera of the eye; The tubular component is configured to provide a fluid passage for draining fluid that enters the extraocular space from the anterior chamber through a second end to the first end of the tubular component; and is formed of at least a non-porous, non-degradable polymer; - At least one patch component that can be positioned under the conjunctiva of the eye, formed from at least one porous, non-degradable polymer, A portable device, including one.

2. The implantable device according to claim 1, wherein the extraocular space is selected from the posterior space of the eye, the posterior orbital space, and the intramuscular space.

3. The implantable device according to any one of claims 1 to 2, wherein the at least one nonporous, non-degradable polymer is selected from polyurethane, polycarbonate, poly(ethylene-co-vinyl acetate)vinyl acetate, poly(methyl methacrylate), poly(propylene carbonate), poly(vinylidene fluoride), polyacrylonitrile, polycarbomethylsilane, polylactic acid, polystyrene, polyvinylpyrrolidone, polyvinyl alcohol (PVA), polyethylene oxide (PEO), polyurethane, polyvinyl chloride (PVC), hyaluronic acid (HA), polyhydroxybutyric acid and its copolymers, nylon 11, cellulose acetate, poly(3-hydroxybutyric acid-co-3-hydroxyvaleric acid), poly(DL-lactide), polycaprolactone, and poly(L-lactide) or any combination thereof.

4. The implantable device according to any one of claims 1 to 3, wherein the tubular component has a length of at least 10 mm.

5. The implantable device according to any one of claims 1 to 4, wherein the tubular component has a length between approximately 10 mm and approximately 100 mm.

6. The implantable device according to any one of claims 1 to 5, wherein the tubular component has an inner diameter of at least 50 microns.

7. The implantable device according to any one of claims 1 to 6, wherein the tubular component has an inner diameter between approximately 50 microns and approximately 150 microns.

8. The implantable device according to any one of claims 1 to 7, wherein the tubular component has a length and inner diameter according to the Hagen-Poiseuille method to provide controlled resistance to fluid outflow from the anterior chamber of the eye to the extraocular space.

9. The implantable device according to any one of claims 1 to 8, wherein the at least one patch component is positioned on the tubular component.

10. The implantable device according to any one of claims 1 to 9, wherein the at least one patch component has a thickness of less than 100 microns.

11. The implantable device according to any one of claims 1 to 10, wherein the at least one patch component has a thickness between about 10 and about 100 microns.

12. The implantable device according to any one of claims 1 to 11, wherein the at least one porous non-degradable polymer is selected from polycarbonate, poly-L-lactic acid (PLLA), poly(DL-lactide-co-caprolactone), poly(ethylene-co-vinyl acetate)vinyl acetate, poly(methyl methacrylate), poly(propylene carbonate), poly(vinylidene fluoride), polyacrylonitrile, polycarbomethylsilane, polylactic acid, polystyrene, polyvinylpyrrolidone, polyvinyl alcohol (PVA), polyethylene oxide (PEO), polyurethane, polyvinyl chloride (PVC), hyaluronic acid (HA), polyhydroxybutyric acid and its copolymers, nylon 11, cellulose acetate, poly(3-hydroxybutyric acid-co-3-hydroxyvaleric acid), poly(DL-lactide), polycaprolactone, and poly(L-lactide) or any combination thereof.

13. The implantable device according to any one of claims 1 to 12, wherein the porous, non-degradable polymer is a nonwoven fabric.

14. The implantable device according to any one of claims 1 to 13, wherein the porous, non-degradable polymer comprises nanofibers.

15. The implantable device according to any one of claims 1 to 14, wherein the porous, non-degradable polymer is electrospun.

16. The implantable device according to any one of claims 1 to 15, wherein the porous, non-degradable polymer has pores of less than 5 microns.

17. The implantable device according to any one of claims 1 to 16, wherein the porous, non-degradable polymer has pores between about 0.01 microns and about 5 microns.

18. The implantable device according to any one of claims 1 to 17, wherein the at least one patch component further comprises at least one pharmaceutically active agent.

19. The implantable device according to any one of claims 1 to 18, wherein the at least one patch component further comprises at least one pharmaceutically active agent selected from antifibrotic agents, anticoagulants, antithrombotic agents, antibiotics, anti-inflammatory agents, biodegradable materials, antihypertensive agents, anti-angiogenic agents, or any combination thereof.

20. - A tubular component comprising at least one tube, having an elongated body having a first end that can be positioned in the anterior chamber of the eye and a second end that can be positioned in the extraocular space, and having an entry point through the sclera of the eye; The tubular component is configured to provide a fluid passage for draining fluid that enters the first end of the tubular component from the anterior chamber to the extraocular space via the second end; and is formed of at least a non-porous, non-degradable polymer; - At least one patch component that can be positioned beneath the conjunctiva of the eye, formed from at least one porous, non-degradable polymer; - Instructions for using the aforementioned kit, A kit that includes this.

21. - To provide the device according to any one of claims 1 to 20; and - Implanting the device into the target eye such that the tubular component passes through an entry point and through the sclera of the eye, and the first end of the tubular component is positioned in the anterior chamber of the eye and the second end of the tubular component is positioned in the extraocular space; and - Positioning the patch component so as to cover the conjunctiva of the eye, the tubular component, and the scleral entry point. A method for controlling fluid outflow from the anterior chamber of the eye, including the method described above.

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