Device for treating eye diseases

Abstract

To provide a device for lowering or reducing the intraocular pressure.SOLUTION: A treatment device 1 comprises a plate structure 200, or simply a plate, having: a first major exposed surface 201 opposite a second major exposed surface 202; and a side surface 203 extending therebetween. The plate structure includes an extension portion 250 and a main body portion 240. Once the treatment device 1 is implanted, fluid (e.g., aqueous humor) is driven by a pressure gradient to flow through channels and across a surface of the plate structure 200.SELECTED DRAWING: Figure 1

Description

[Technical field]

[0001] (CROSS REFERENCE TO RELATED APPLICATIONS) This application claims priority to U.S. Provisional Application No. 62 / 794,139, filed January 18, 2019, the entire disclosure of which is incorporated herein by reference. [Background technology]

[0002] Millions of people suffer from eye diseases, especially glaucoma. Most glaucoma patients have abnormally high intraocular pressure (IOP) due to the inability of excess aqueous humor to drain from the eye chamber through the trabecular meshwork. As the disease progresses, high IOP continues to damage the optic nerve, leading to reduced vision or blindness, unless appropriate treatment is used to lower the IOP. Current drug treatments, surgeries, and implants have proven inadequate to lower or normalize IOP for many years. Thus, novel methods are needed to alleviate IOP and thereby treat glaucoma. Summary of the Invention [Means for solving the problem]

[0003] Described herein are therapeutic devices, or simply devices, useful for treating ocular conditions. In some embodiments, the ocular condition is intraocular pressure, and the devices described herein reduce intraocular pressure. The devices are generally plate structures or core components that include a first major surface coated with a first material, and a second major surface coated with a second material. In some embodiments, the plate or core component is simply coated, and the first and second coatings are not defined.

[0004] The plate structures or plates may have a thickness ranging from about 1 nm to about 1,000 nm, or from about 50 nm to about 800 nm.

[0005] The plate structure can include channels that aid in the movement of fluid through the eye, thereby reducing intraocular pressure.

[0006] Another embodiment includes a method of reducing intraocular pressure, in some embodiments, the method includes securing a device described herein to an eye, thereby displacing intraocular fluid and reducing intraocular pressure.

[0007] In some embodiments, a device is described for lowering or reducing intraocular pressure, the device comprising a plate structure including a first surface opposite a second surface, the first surface including a series of fluid channels, a first coating on the first surface, and a second coating on the second surface.

[0008] In some embodiments, the plate structure is formed of a ceramic material, which may be selected from alumina, silicon nitride, silica, hafnium oxide, titanium nitride, and titanium.

[0009] In some embodiments, the first coating is a polymeric material. The polymeric material may be a parylene polymer. The parylene polymer may be parylene C, parylene D, parylene N, derivatives thereof, or combinations thereof.

[0010] In some embodiments, the polymeric material includes rubber, synthetic rubber, silicone polymer, parylene, thermoplastics, thermosets, polyolefins, polyisobutylene, acrylic polymers, ethylene-co-vinyl acetate, polybutyl methacrylate, vinyl halide polymers, polyvinyl ethers, polyvinylidene halides, polyacrylonitrile, polyvinyl ketones, polyvinyl aromatics, polyvinyl esters, acrylonitrile-styrene copolymers, ABS resins, ethylene-vinyl acetate copolymers, polyamides, alkyd resins, polycarbonates, polyoxymethylene, polyimides, polyethers, epoxy resins, polyurethanes, rayon, cellulose, cellulose acetate, cellulose butyrate, cellulose acetate butyrate, cellophane, cellulose nitrate, cellulose propionate, cellulose ethers, carboxymethylcellulose, polytetrafluoroethylene, poly(ether-ether-ketone), polylactides such as PLA, PLGA, PLLA, derivatives thereof, or combinations thereof.

[0011] In some embodiments, the second coating includes aluminum oxide and / or a parylene polymer.

[0012] In some embodiments, the second coating includes aluminum oxide in combination with rubber, synthetic rubber, silicone polymer, parylene, thermoplastic resin, thermoset resin, polyolefin, polyisobutylene, acrylic polymer, ethylene-co-vinyl acetate, polybutyl methacrylate, vinyl halide polymer, polyvinyl ether, polyvinylidene halide, polyacrylonitrile, polyvinyl ketone, polyvinyl aromatic resin, polyvinyl ester, acrylonitrile-styrene copolymer, ABS resin, ethylene-vinyl acetate copolymer, polyamide, alkyd resin, polycarbonate, polyoxymethylene, polyimide, polyether, epoxy resin, polyurethane, rayon, cellulose, cellulose acetate, cellulose butyrate, cellulose acetate butyrate, cellophane, cellulose nitrate, cellulose propionate, cellulose ether, carboxymethylcellulose, polytetrafluoroethylene, poly(ether-ether-ketone), polylactides such as PLA, PLGA, PLLA, derivatives thereof, or combinations thereof.

[0013] The series of fluid channels can include multiple open-ended channels that interconnect to form a crisscrossing network of fluid pathways, hi some embodiments, the channels are microchannels.

[0014] In some embodiments, the device further comprises an agent. In some embodiments, the agent(s) may be present in the microchannel. In some embodiments, the agent(s) may be retained in the microchannel by a coating.

[0015] Also described are methods of treatment. In some embodiments, methods are described that include inserting a device into an eye with high intraocular pressure and treating high intraocular pressure or ocular hypertension, the device including a plate structure including a first surface opposite a second surface, the first surface including a series of fluid channels, a first coating on the first surface, and a second coating on the second surface.

[0016] The method further includes fixating the device to the eye, which may be to the sclera or any other part of the eye.

[0017] In some embodiments, at least a portion of the first surface faces the conjunctiva of the eye and at least a portion of the second surface faces the sclera of the eye.

[0018] In some embodiments, the device forms a fluid pathway that provides fluid communication between the anterior chamber of the eye and the device location.

[0019] Additionally, the fluid pathway includes a series of fluid channels.

[0020] In some embodiments, the treatment for ocular hypertension is treatment for glaucoma.

[0021] Further scope of applicability of the present invention will become apparent from the detailed description provided hereinafter. It should be understood that the detailed description and examples are for illustrative purposes only and are not intended to limit the scope of the present invention. [Brief description of the drawings]

[0022] The present invention will become more fully understood from the detailed description and the accompanying drawings, wherein:

[0023] [Figure 1] FIG. 1 is a perspective view of an apparatus according to one embodiment. [Diagram 2] FIG. 2 is an enlarged view of the device according to portion A identified in FIG. 1. [Diagram 3] FIG. 3 is a cross-sectional view of the device taken along line III-III in FIG. 2. [Figure 4] FIG. 13 is a perspective view of an apparatus according to another embodiment. [Figure 5A] 5 is a partial cross-sectional view of portion A of the device shown in FIG. 4, according to one embodiment. [Figure 5B] 5 is a partial cross-sectional view of portion A of the device shown in FIG. 4, according to one embodiment. [Figure 5C]5 is a partial cross-sectional view of portion A of the device shown in FIG. 4, according to one embodiment. [Figure 6] FIG. 2 is a perspective view of an apparatus according to another embodiment of the present invention. [Figure 7] FIG. 7 is a cross-sectional view of the device shown along line XII-XII of FIG. 6, according to one embodiment. [Figure 8] FIG. 2 is a top view of an apparatus according to another embodiment of the present invention. [Figure 9] FIG. 10 is a cross-sectional view of the device shown along line XIV-XIV of FIG. 8, according to one embodiment. [Figure 10] FIG. 13 is a perspective view of an apparatus according to another embodiment. [Figure 11] 16 is a cross-sectional view of the device shown along line XVI-XVI of FIG. 10, according to one embodiment. [Figure 12] FIG. 17 is a cross-sectional view of the device shown along line XVII-XVII of FIG. 10, according to one embodiment. [Figure 13] FIG. 2 is an enlarged view of an implantation device for implanting the device described above. [Figure 14A] FIG. 14 is a partial cross-sectional view of an eye having a device implanted therein using the implantation device of FIG. 13. [Figure 14B] FIG. 14 is a cross-sectional view of an eye having a device implanted therein using the implantation device of FIG. 13. [Figure 15] FIG. 14 is a partial cross-sectional view of the device of FIG. 13 during implantation. [Figure 16] FIG. 14 is a partial cross-sectional view of the device of FIG. 13 during implantation. [Figure 17] 1 is a first state of the device for implanting a device as described herein. [Figure 18] 2 is a second state of the device for implanting a device as described herein. [Figure 19] According to another embodiment, an implantation apparatus for implanting a device. [Figure 20] According to another embodiment, an implantation apparatus for implanting a device. [Figure 21] FIG. 21 is an enlarged partial cross-sectional view of an eye implanted with a device described herein using the implantation device of FIGS. [Figure 22] 1 illustrates an embodiment of an apparatus as described herein. [Figure 23] 1 illustrates an embodiment of an inserter or insertion device as described herein. [Figure 24] 1 shows intraocular pressure following insertion of a device described herein. [Diagram 25] 1 shows a comparison of intraocular pressure with a device described herein and a SIBS device. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0024] The following description of the embodiments is merely illustrative and is not intended to limit the invention, its application, or uses.

[0025] As used throughout, ranges are used as shorthand for describing each value within a range. Any value within a range can be selected as the end of the range. Furthermore, all references cited herein are incorporated in their entirety. In the event of discrepancy between the definitions of this disclosure and those of the cited references, this disclosure controls.

[0026] The description of exemplary embodiments according to the principles of the invention is intended to be read in connection with the accompanying drawings, which are to be considered part of the entire description. In describing the embodiments of the invention disclosed herein, references to directions or orientations are intended for convenience of description only and are not intended to limit the scope of the invention. Relative terms such as "lower", "upper", "horizontal", "vertical", "on", "down", "up", "down", "above", "below" and derivatives thereof (e.g., "horizontally", "downward", "upwardly", etc.) should be interpreted to mean the directions currently being described or as shown in the drawings referenced.

[0027] The terms "attached," "attached," "connected," "coupled," "interconnected," and similar terms refer to structures that are fixed or attached to one another, either directly or indirectly through an intervening structure, including both movable and fixed attachment or association, unless otherwise specified. Moreover, features and advantages of the present invention are illustrated by reference to the illustrated embodiments. Thus, the present invention should not be expressly limited to the illustrative embodiments, which show non-limiting combinations of features that may exist alone or in combination with other features, and the scope of the invention is defined by the appended claims.

[0028] Unless otherwise specified, all percentages and amounts expressed herein and elsewhere should be understood to mean weight percentages. The amounts stated are based on the weight of the material. According to the present application, the term "about" means ±5% of the reference value. According to the present application, the term "substantially free" means about 0.1% by weight or less based on the total reference amount.

[0029] As used herein, a "subject" refers to a human or non-human animal, including, but not limited to, rodents such as mice, rats, hamsters, and guinea pigs, rabbits, dogs, cats, sheep, pigs, goats, cows, horses, and non-human primates such as apes and monkeys.

[0030] 1-3, the treatment device 1, or simply device, may include a plate structure 200, or simply plate, having a first major exposed surface 201 opposite a second major exposed surface 202, and a side surface 203 extending therebetween. The plate structure 200 may include an extension portion 250 and a body portion 240.

[0031] The plate structure 200 can be made of any material having suitable characteristics for implantation and treatment. In some embodiments, the plate structure 200 can be made of metals, polymers, ceramics, other composite materials, or combinations thereof. Metals can include, but are not limited to, aluminum, titanium, zinc, platinum, tantalum, copper, nickel, rhodium, gold, silver, palladium, chromium, iron, indium, ruthenium, osmium, tin, iridium, or combinations thereof, and alloys thereof. In some embodiments, alloys can include steel and nickel titanium, such as Nitinol.

[0032] The polymer or polymeric material used to form the plate structure 200 may include any of the polymers described herein.

[0033] Composite materials, such as silicon composite materials, may also be used. In an embodiment, the composite material may include silicon nitride (Si3N4). Silicon nitride may have any known crystal structure, such as, but not limited to, trigonal α-Si3N4, hexagonal β-Si3N4, or cubic γ-Si3N4.

[0034] The plate structure or plate may have a thickness in the range of about 1 nm to about 1,000 nm, about 1 nm to about 500 nm, about 1 nm to about 400 nm, about 100 nm to about 1,000 nm, about 200 nm to about 1,000 nm, about 300 nm to about 1,000 nm, about 400 nm to about 1,000 nm, about 1 nm to about 900 nm, about 1 nm to about 800 nm, about 1 nm to about 700 nm, about 1 nm to about 600 nm, about 300 nm to about 500 nm, about 300 nm to about 600 nm, about 400 nm to about 600 nm, about 200 nm to about 600 nm, about 200 nm to about 500 nm, or about 50 nm to about 800 nm.

[0035] The plate structure 200 may comprise a multi-directional plate 210 including a first major surface 211 opposite a second major surface 212. The multi-directional plate 210 may have a plurality of topographical features (e.g., a repeating honeycomb pattern) formed on each of the first major surface 211 and the second major surface 212. Each of the first and second topographies may independently include a plurality of channels 232 and / or a plurality of open cells 222.

[0036] The multiple channels 232 can be interconnected to form a network of channels. The channels are open to allow fluid to readily enter and flow through each channel of the multiple channels 232. The network may include intersecting channels in any suitable configuration that is most conducive to facilitating fluid flow across the plate structure 200 through the multiple channels 232. In an embodiment, the channels may be configured to form a hexagonal pattern. When the treatment device 1 shown in FIG. 1 is implanted, fluid (e.g., aqueous humor) is driven by a pressure gradient to flow through the channels and across the surface of the plate structure 200.

[0037] In some embodiments, the channels may include a rib pattern. The rib pattern and / or shape of the channels in the plate may vary based on the severity of glaucoma. In some embodiments, larger or smaller channels may be used to vary the amount of intraocular pressure reduction. Small changes in intraocular pressure may reduce the risk of hypotony (a condition that can occur if intraocular pressure is lowered too much) and increase the effectiveness of pressure reduction. In some embodiments, devices with smaller channels, as described herein, may reduce flow and reduce the risk of hypotony. Similarly, larger channels may increase flow and increase the effectiveness of the device in reducing intraocular pressure.

[0038] The plate structure 200 may further include a first coating 280 applied to the first major surface 211 of the multi-directional plate 210. The first coating 280 may conform to the first topography of the first major surface 211 of the multi-directional plate 210. In another embodiment, the first coating 280 may form a topography that does not conform to the first topography of the first major surface 211 of the multi-directional plate 210.

[0039] The first coating 280 may have a thickness ranging from about 0.1 μm to about 10 μm, or from about 0.1 μm to about 1 μm, including all thicknesses and subranges therebetween. In some embodiments, the thickness is between about 0.4 μm (400 nm) and 0.6 μm (600 nm). In some embodiments, the thickness is about 0.4 μm (400 nm). In other embodiments, the thickness is between about 1 μm and about 5 μm, between about 1 μm and about 3 μm, between about 2 μm and about 5 μm, or between about 2 μm and about 4 μm. In some embodiments, the thickness is about 2 μm.

[0040] The plate structure 200 may further include a second coating 290 applied to the second major surface 212 of the multi-directional plate 210. The second coating 290 may conform to features of the surface of the second major surface 212 of the multi-directional plate 210. In another embodiment, the second coating 290 may form a topography that does not conform to the second topography of the second major surface 212 of the multi-directional plate 210.

[0041] The second coating 290 may have a thickness ranging from about 0.1 μm to about 10 μm, or from about 0.1 μm to about 1 μm, including all thicknesses and subranges therebetween. In some embodiments, the thickness is between about 0.4 μm (400 nm) and 0.6 μm (600 nm). In some embodiments, the thickness is about 0.4 μm (400 nm). In other embodiments, the thickness is between about 1 μm and about 5 μm, between about 1 μm and about 3 μm, between about 2 μm and about 5 μm, or between about 2 μm and about 4 μm. In some embodiments, the thickness is about 2 μm.

[0042] In some embodiments, the plate structure 200 may include only the first coating 280 - i.e., no second coating. In some embodiments, the plate structure 200 may include only the second coating 290 - i.e., no first coating. In another embodiment, the plate structure 200 may include a first coating 280 and a second coating, where the first and second coatings may overlap to completely encase the multi-directional plate 210. In such an embodiment, the side 203 of the plate structure 200 may include at least one of the first coating 280 and the second coating 290.

[0043] In some embodiments, the first and second coatings, as well as any edge coatings, may be thicker than the plate itself. In some embodiments, the thickness of the coatings may be one, two, or three orders of magnitude thicker than the plate structure. However, in other embodiments, the plate structure may be thicker than each coating, or the sum of the thicknesses of the two coatings.

[0044] The coatings described herein can be applied by any suitable deposition method, including, but not limited to, chemical vapor deposition, atomic layer deposition, spray coating, dip coating, or brushing.

[0045] First coating 280 may be applied to first major surface 211 by any suitable deposition method. In a non-limiting example, first coating 280 may be applied to first major surface 211 by chemical vapor deposition. In another non-limiting example, first coating 280 may be applied to first major surface 211 by atomic layer deposition. In another non-limiting example, first coating 280 may be applied to first major surface 211 by spray coating. In another non-limiting example, first coating 280 may be applied to first major surface 211 by dip coating. In another non-limiting example, first coating 280 may be applied to first major surface 211 by brushing.

[0046] Second coating 290 may be applied to second major surface 212 by any suitable deposition method. In a non-limiting example, second coating 290 may be applied to second major surface 212 by chemical vapor deposition. In another non-limiting example, second coating 290 may be applied to second major surface 212 by atomic layer deposition. In another non-limiting example, second coating 290 may be applied to second major surface 212 by spray coating. In another non-limiting example, second coating 290 may be applied to second major surface 212 by dip coating. In another non-limiting example, second coating 290 may be applied to second major surface 212 by brushing.

[0047] The first coating 280 may be the same as the second coating 290. The first coating 280 and the second coating 290 may be different. The first coating 280 may be hydrophilic. The first coating 280 may be hydrophobic. The first coating 280 may be oleophilic. The first coating 280 may be oleophobic. The second coating 290 may be hydrophilic. The second coating 290 may be hydrophobic. The second coating 290 may be oleophilic. The second coating 290 may be oleophobic. Each of the first and second coatings 280, 290 may be independently continuous. Each of the first and second coatings 280, 290 may be independently discontinuous. In some embodiments, both the first and second coatings 280, 290 may be hydrophobic. In some embodiments, both the first and second coatings 280, 290 may be hydrophilic. In some embodiments, both the first and second coatings 280, 290 may be oleophilic.

[0048] The first coating 280 may be organic. The first coating 280 may be inorganic. The second coating 290 may be organic. The second coating 290 may be inorganic.

[0049] In some embodiments, the first coating 280 is hydrophilic and the second coating 290 is hydrophobic. In some embodiments, the first coating 280 is hydrophilic and the second coating 290 is hydrophilic. The hydrophobic nature of at least one of the first and / or second coatings 280, 290 may prevent the therapeutic device 1 from inadvertently adhering to tissue during implantation.

[0050] In some embodiments, the purpose of the first and / or second coating is to increase the robustness of the device. The first and / or second coating can also increase the biocompatibility of the device and / or reduce scarring by reducing tissue and / or fibroblast adhesion. In some embodiments, the coatings described herein are hydrophobic and reduce tissue adhesion. In some embodiments, tissue adhesion can be reduced by more than about 50%, more than about 60%, more than about 70%, more than about 80%, more than about 90%, more than about 95%, more than about 96%, more than about 97%, more than about 98%, or more than about 99% when compared to an uncoated plate.

[0051] In a non-limiting embodiment, the first and / or second coating can include a parylene polymer, such as a parylene polymer (poly(paraxylylene)) or a derivative thereof. In another embodiment, the first and / or second coating can include aluminum oxide. In an embodiment, the parylene polymer is a chlorine-modified poly(paraxylylene), a fluorine-modified poly(paraxylylene). In an embodiment, the parylene polymer can be parylene C, parylene D, parylene N, derivatives thereof, or combinations thereof. In another embodiment, the first and / or second coating can include aluminum oxide.

[0052] In some embodiments, other polymer(s) can be used in addition to, in combination with, or in place of the parylene polymer and / or aluminum oxide. In some embodiments, the other polymeric materials can include, but are not limited to, rubber, synthetic rubber, silicone polymers, thermoplastics, thermosets, polyolefins, polyisobutylene, acrylic polymers, ethylene-co-vinyl acetate, polybutyl methacrylate, vinyl halide polymers (e.g., polyvinyl chloride), polyvinyl ethers (e.g., polyvinyl methyl ether), polyvinylidene halides, polyacrylonitrile, polyvinyl ketones, polyvinyl aromatics, polyvinyl esters, acrylonitrile-styrene copolymers, ABS resins, ethylene-vinyl acetate copolymers, and the like. The polymeric material may include polyamides (e.g., nylon 66 and polycaprolactam), alkyd resins, polycarbonates, polyoxymethylene, polyimides, polyethers, epoxy resins, polyurethanes, rayon, cellulose, cellulose acetate, cellulose butyrate, cellulose acetate butyrate, cellophane, cellulose nitrate, cellulose propionate, cellulose ethers, carboxymethyl cellulose, polytetrafluoroethylene (e.g., Teflon), poly(ether-ether-ketone), polylactides such as PLA, PLGA, PLLA, derivatives thereof, or combinations thereof.

[0053] The resulting treatment device 1 may include a first plurality of channels 222 present on the first exposed major surface 201 of the plate structure 200, the first plurality of channels 222 being hydrophilic due to the presence of the first coating 280. The resulting treatment device 1 may include a second plurality of channels 232 present on the second exposed major surface 202 of the plate structure 200, the second plurality of channels 232 being hydrophilic due to the presence of the second coating 290. As discussed, the hydrophilic channels may facilitate fluid flow therethrough after the device 1 is implanted in a subject's eye.

[0054] 4, 5A, 5B, and 5C, a therapy device 1001 is generally shown according to another embodiment. The therapy device 1001 is similar to therapy device 1, except as described below. The description of therapy device 1 above generally applies to therapy device 1001 below, except for the differences noted below. A similar numbering scheme is used for device 1001 as for device 1, except that numbers in the "1000" series are used.

[0055] The treatment device 1001 comprises a plate structure 1200 having a first major exposed surface 1201 opposite a second major exposed surface 1202. The plate structure 1200 may comprise a multi-directional plate 1210 including a first major surface 1211 opposite a second major surface 1212. The multi-directional plate 1210 may define a plurality of topographical features (e.g., a repeating honeycomb pattern) on each of the first major surface 1211 and the second major surface 1212. Each of the first and second topographies may independently include a plurality of channels 1232 and / or a plurality of open cells 1222.

[0056] 5B, the plate structure 1200 can include a first delivery component 1070 that resides in an open void created by a first topography formed by a first major exposed surface 1211 of the multi-directional plate 1210. In particular, the first delivery component 1070 can reside in an open void created by open cells 1222 of the first topography formed by the first major exposed surface 1211 of the multi-directional plate 1210.

[0057] The first delivery component 1070 may include one or more active agents, such as, but not limited to, therapeutic and / or pharmaceutical components. The first delivery component 1070 may occupy some, all, or substantially all of the empty volume present in the open cells 1222 formed by the first topography.

[0058] In some embodiments, the active agent can include any compound or drug that has a therapeutic effect in a subject. Non-limiting active agents include anti-proliferative agents, including, but not limited to, macrolide antibiotics, including FKBP-12 binding compounds, estrogens, chaperone inhibitors, protease inhibitors, protein-tyrosine kinase inhibitors, leptomycin B, peroxisome proliferator-activated receptor gamma ligands (PPARγ), hypothemycin, nitric oxide, bisphosphonates, epidermal growth factor inhibitors, antibodies, steroids, proteasome inhibitors, antibiotics, anti-inflammatory agents, antisense nucleotides, transforming nucleic acids, IOP-lowering agents, prostaglandins, cytostatic compounds, toxic compounds, anti-inflammatory compounds, chemotherapeutic agents, analgesics, antibiotics, protease inhibitors, statins, nucleic acids, polypeptides, growth factors, and delivery vectors such as recombinant microorganisms, liposomes, antimetabolites such as mitomycin C, combinations thereof, prodrugs thereof, pharmaceutical salts thereof, derivatives thereof, and the like.

[0059] The therapeutic device 1001 may further include a first coating 1050 applied to the first major exposed surface 1211 of the multi-directional plate 1210. The first coating 1050 may cover both the first major exposed surface 1211 of the multi-directional plate 1210 and the first delivery component 1070 present in the open cells 1222 formed in the first major exposed surface 1211 of the multi-directional plate 1210. The first coating 1050 may be formed into a continuous film. The first coating 1050 may be flat. In another embodiment, the first coating 1050 may conform to an underlying pattern formed by the multi-directional plate 1210 and the first delivery component 1070.

[0060] 5A , the plate structure 1200 can include a second delivery component 1080 that resides in an open void created by a second topography formed by the second major exposed surface 1212 of the multi-directional plate 1210. In particular, the second delivery component 1080 can reside in a void created by an open channel 1232 of the second topography formed by the second major exposed surface 1212 of the multi-directional plate 1210.

[0061] The second delivery component 1080 may be the same as the first delivery component 1070 or may be different.

[0062] The second delivery component 1080 may include one or more therapeutic and / or medicinal components, including but not limited to anti-inflammatory agents, steroids, antibiotics, pain relievers, etc. The second delivery component 1080 may occupy some, all, or substantially all of the empty volume present in the channel 1232 formed by the first topography.

[0063] The treatment device 1001 may further include a second coating 1060 applied to the second major exposed surface 1212 of the multi-directional plate 1210. The second coating 1060 may cover both the second major exposed surface 1212 of the multi-directional plate 1210 and the second delivery component 1080 present in the open channels 1232 formed in the second major exposed surface 1212 of the multi-directional plate 1210. The second coating 1060 may be formed into a continuous film. The second coating 1060 may be flat. In another embodiment, the second coating 1060 may conform to an underlying pattern formed by the multi-directional plate 1210 and the second delivery component 1080.

[0064] The second coating 1060 may be the same as or different from the first coating 1050. For each of the first and second coatings 1050, 1060, the resulting film may be formed from a sustained release material that slowly dissolves after exposure to aqueous humor or other biological fluids, thereby causing the first delivery component 1070 to be released from the channel 1232 of the therapeutic device 1001 after the therapeutic device 1001 is implanted in a subject.

[0065] Referring to FIG. 5C, in another embodiment, the therapeutic device 1001 may include both first and second delivery components 1070, 1080, as well as first and second coatings 1050, 1060 for encasing the first and second delivery components 1070, 1080.

[0066] In another embodiment, the plate structure 1200 may include at least one of the first coating 1050 and / or second coating 1060 without the first and / or second delivery components 1070, 1080. In such an embodiment, the first coating 1050 and / or second coating 1060 may form a film that covers the open cells 1222 and / or open channels formed by the multi-directional plate.

[0067] The presence of the film resulting from the first and / or second coatings 1050, 1060 can increase the overall strength of the resulting therapeutic device. In particular, the layer structure(s) formed by the first and / or second coatings 1050, 1060 and bonded to the first and second major surfaces 1211, 1212 of the multi-directional plate 1210 provide additional mechanical strength to the resulting therapeutic device.

[0068] In addition to achieving a basic flexibility to conform to the curvature of the eye, the addition of the first and / or second coatings 1050, 1060 may provide a mechanism by which the entire therapeutic device can match the elastic modulus of the surrounding conjunctival and scleral tissues to maximize biointegration. Findings in brain implantation studies confirm that flexibility of the implant in the parenchyma improves the implant's conformance to micro-movements of the surrounding tissues, reducing tissue displacement and trauma and facilitating implantation of the therapeutic device.

[0069] 6 and 7, a therapy device 2001 is shown according to another embodiment. The therapy device 2001 is similar to therapy device 1, 1001, except as described below. The description of therapy device 1, 1001 above generally applies to therapy device 2001 below, except for the differences noted below. A similar numbering scheme is used for device 2001 as for device 1, 1001, except that numbers in the "2000" series are used.

[0070] The treatment device 2001 may include a piercing element 2100 provided as separate components, and a plate structure 2200, with the piercing element 2100 coupled to the plate structure 2200. The piercing element 2100 and the plate structure 2200 may be coupled together by any suitable means, such as, but not limited to, adhesives, fasteners, etc. Non-limiting examples of adhesives include glues, acrylics such as cyanoacrylates, epoxies, thermosets, thermoplastics, elastomers, polydimethylsiloxane (PDMS), epoxies, silicones, polyurethanes, etc. Non-limiting examples of fasteners include anchors, straps, buckles, tapes, or any other restraining devices. In some embodiments, fasteners are used in combination with adhesives.

[0071] Plate structure 2200 may include a first major exposed surface 2201 opposite second major exposed surface 2202, and an exposed side surface 2203 extending between first major exposed surface 2201 and second major exposed surface 2202. To the naked eye, first major exposed surface 2201 of plate structure 2200 may appear substantially continuous and smooth. To the naked eye, second major exposed surface 2202 of plate structure 2200 may appear substantially continuous and smooth.

[0072] The piercing element 2100 may include an outer surface 2101 and an inner surface 2102. The piercing element 2100 may include an elongated body 2110. The elongated body 2110 may include an outer surface 2112 and an inner surface 2111. The piercing element 2100 may further include a passageway 2140 (also referred to herein as a "lumen passageway") extending through the elongated body 2110. The inner surface 2111 may be continuous and form a D-shaped cross-section. The D-shaped cross-section causes the outer surface 2112 to have a curved portion 2118 and a substantially flat portion 2117 that joins with at least one of the first major exposed surface 2201 or the second major exposed surface 2202 of the plate structure. The flat portion 2117 provides a good connection with the smooth and / or flat major surfaces 2201, 2202 of the plate structure.

[0073] 8-9, a treatment device 3001 is shown according to another embodiment. Treatment device 3001 is similar to treatment devices 1, 1001, 2001, except as described below. The description of treatment devices 1, 1001, 2001 above generally applies to treatment device 3001 below, except for the differences noted below. A similar numbering scheme is used for device 3001 as for devices 1, 1001, 2001, except that numbers in the "3000" series are used.

[0074] The treatment device 3001 may include a piercing element 3100 provided as separate components, and a plate structure 3200, with the piercing element 3100 coupled to the plate structure 3200. The piercing element 3100 and the plate structure 3200 may be coupled together by any suitable means, such as, but not limited to, adhesives, fasteners, etc. Non-limiting examples of fasteners include anchors, straps, buckles, tapes, or any other restraining devices.

[0075] The plate structure 3200 may include a first major exposed surface 3201 opposite the second major exposed surface 3202. To the naked eye, the first major exposed surface 3201 of the plate structure 3200 may appear continuous and smooth, or substantially continuous and smooth. To the naked eye, the second major exposed surface 3202 of the plate structure 3200 may appear substantially continuous and smooth.

[0076] The first major exposed surface 3201 may include a first region 3211 and a second region 3212. The first region 3211 may be offset from the second major surface 3202 by a first thickness t1. The second region 3212 may be offset from the second major surface by a second thickness t2. The first and second thicknesses t1, t2 may be different. The second thickness t2 may be less than the first thickness t1 such that the second region 3212 forms a recess in the first major exposed surface 3201 of the plate structure 3200.

[0077] The piercing element 3100 may include an outer surface 3101 and an inner surface 3102. The piercing element 3100 may comprise an elongate body 3110. The elongate body 3110 may include an outer surface 3111 and an inner surface 3112. The piercing element 3100 may further comprise a passageway 3140 (also referred to herein as a "lumen passageway") extending through the elongate body 3110. The inner surface 3111 may be continuous and form a circular cross-section. The circular cross-section results in the outer surface being circular in shape. The recess formed by the second region 3212 on the first major exposed surface 3201 can accommodate at least a portion of the circular cross-section of the piercing element 3100, thereby allowing the piercing element to extend into the plate structure 3200, thereby allowing the piercing element 3100 to have a lumen passage 3140 that allows fluid to flow without having the piercing element 3100 protruding far beyond the first region 3211 of the first major exposed eye 3202 of the plate structure 3200.

[0078] 10-12, a therapy device 4001 is shown according to another embodiment. The therapy device 4001 is similar to therapy devices 1, 1001, 2001, 3001, except as noted below. The description of therapy devices 1, 1001, 2001, 3001 above generally applies to therapy device 4001 below, except for the differences noted below. The same numbering scheme is used for device 4001 as for devices 1, 1001, 2001, 3001, except that numbers in the "4000" series are used.

[0079] The treatment device 4001 comprises a first plate structure 4200a and a second plate structure 4200b. The first plate structure 4200a may include a first main surface 4201a opposite the second main surface 4202a. The second plate structure 4200b may include a first main surface 4201b opposite the second main surface 4202b.

[0080] The first main surface 4201a of the first plate structure 4200a may include a first topography. The second main surface 4202a of the first plate structure 4200a may include a second topography. The first main surface 4201b of the second plate structure 4200b may include a first topography. The second main surface 4202b of the second plate structure 4200b may include a second topography.

[0081] The second major surfaces 4202a, 4202b of the first and second plate structures 4200a, 4200b face each other. In some embodiments, at least a portion of the second major surfaces 4202a, 4202b of the first and second plate structures 4200a, 4200b may be in contact with each other. In some embodiments, at least a portion of the second major surfaces 4202a, 4202b of the first and second plate structures 4200a, 4200b may be in floating contact with each other. In some embodiments, at least a portion of the second major surfaces 4202a, 4202b of the first and second plate structures 4200a, 4200b may be offset from each other such that there is no contact between the second major surfaces 4202a, 4202b of the first and second plate structures 4200a, 4200b.

[0082] The treatment device 4001 may further include a piercing element 4100 located between the first and second plate structures 4200a, 4200b. The piercing element 4100 may be coupled to at least one of the first and second plate structures 4200a, 4200b by any suitable method, such as, but not limited to, adhesives, fasteners, etc. as previously described. The piercing element 4100 may be coupled to a portion of the second major surfaces 4202a, 4202b of the first and second plate structures 4200a, 4200b.

[0083] According to this embodiment, the piercing element 4100 extends between the first and second plate structures 4200a, 4200b such that the elongated body 4110 of the passageway 4140 formed by the piercing element 4100 also extends between the plate structures 4200a, 4200b. In this configuration, fluid enters the elongated body 4110, travels along the passageway 4140, and exits between the second major surfaces 4202a, 4202b of the first and second plate structures 4200a, 4200b. Portions of the second major surfaces 4202a, 4202b of the first and second plate structures 4200a, 4200b that are in floating contact may separate in the presence of such fluid to allow the fluid to spread along the second major surfaces 4202a, 4202b of the first and second plate structures 4200a, 4200b.

[0084] The first and second main surfaces 4201a, 4202a of the first plate structure 4200a have a first surface area, and the first and second main surfaces 4201b, 4202b of the second plate structure 4200b have a second surface area. The first and second surface areas may be equal. In another embodiment, the first and second surface areas may be different. The second surface area may be larger than the first surface area.

[0085] The first plate structure 4200a may have a first width and a first length L1. The second plate structure 4200b may have a second width and a second length L2. The first and second widths may be equal. In another embodiment, the first and second widths may be different. The first and second lengths L1, L2 may be equal (not shown). In another embodiment, the first and second lengths L1, L2 may be different, as shown in FIG. 10. The second length L2 may be greater than the first length L1 such that at least a portion of the second main surface 4202b of the second plate structure 4200b does not overlap with the second main surface 4202a of the first plate structure 4200a.

[0086] 13, 14A, and 14B, the embodiment further includes an implantation device 90 configured for implanting the treatment device 1 into the eye 900. The following discussion is made with reference to the treatment device 1, but also applies to treatment devices 1001, 2001, 3001, 4001 described according to other embodiments of the present invention.

[0087] The treatment device 90 may include a handle portion 93 and an insert portion 91, which may include a housing 92 for holding the treatment device 1. The housing 92 may be configured in any shape suitable for holding the treatment device 1. In a non-limiting example, the housing 92 may be an open-ended cavity into which the treatment device 1 is disposed.

[0088] During implantation, the implantation device 90 may be inserted into the eye 900 such that the treatment device 1 may be placed in contact with the eye 900 for treatment of an ocular disease, such as glaucoma. Specifically, the insertion portion 91 may be inserted through the sclera 913 and into the anterior chamber 988 of the eye 900 such that a distal portion of the treatment device 1 is positioned in the anterior chamber 988 of the eye 900. Once the treatment device 1 is in place, the treatment device 90 may be removed from the eye 900, and the treatment device 1 will exit the housing 92 of the implantation device 90 and remain in the eye 900.

[0089] Once in place, the plate structure 200 of the treatment device 1 can be positioned between the sclera 913 and the conjunctival tissue 950. In this configuration, the plate structure 200 acts as a tissue separator and / or an external reservoir for excess fluid while the fluid is absorbed into the surrounding tissue of the subject.

[0090] 15 and 16, the release decal 400 may be coupled to at least one of the major surfaces of the treatment device 1. The release decal 400 may be reversibly adhered to one of the major surfaces 212, 202 of the plate structure 200 of the treatment device 1 such that the release decal 400 may be removed by peeling from the major surfaces of the treatment device 1, but will resist shear separation from the major surfaces of the treatment device 1.

[0091] The release decal 400 may be formed from materials including, but not limited to, polytetrafluoroethylene (PTFE), one or more metals, silicone, PDMS, glass, and / or one or more resins.

[0092] The release decal 400 may include a decal nub 410 that provides a feature that allows a user to directly or indirectly manipulate the position of the treatment device 1 relative to the underlying ocular tissue, specifically the sclera 913. For example, the decal nub may be manipulated by the insertion portion 91 of the implantation device 1 after the treatment device 1 is released from the housing 92 of the implantation device 1. In another embodiment, a separate tool may be used to engage the decal nub 410 to manipulate the position of the treatment device 1 on the sclera 913.

[0093] Having the decal nub 410 allows for precise adjustment of the position of the plate structure 200 of the treatment device 1 along the sclera 913 so that the penetrating elements 100, 2100, 3100, 4100 of the embodiments of Figures 6-12, or the extension 250 of the embodiment shown in Figure 1, can be precisely positioned within the anterior chamber 988 to optimally remove excess fluid present within the eye 900.

[0094] The bond strength between the release decal 400 and the treatment device 1 may be strong enough to withstand shear, thereby allowing lateral movement of both the release decal 400 and the treatment device 1. However, once the treatment device 1 is correctly positioned, the release decal 400 may be removed from the treatment device 1, for example, by peeling the release decal 400 off of the treatment device 1, by lifting the release decal 400 off of the treatment device 1 in a direction substantially perpendicular to a major surface of the treatment device 1.

[0095] 17 and 18, the embodiment further includes an implantation device 80, which may be configured to implant the treatment device 1 into the eye 900. The following discussion is made with reference to the treatment device 1, but also applies to the treatment devices 1001, 2001, 3001, 4001.

[0096] According to this embodiment, a support base may be used in combination with the treatment device 1. Specifically, the treatment device 1 may be placed on the support base, and the treatment device and the support base may be grasped together by an applicator having a first support 81 and a second support 82. In a non-limiting embodiment, the applicator 80 may be a forceps. As shown in FIG. 17, in a first state, the first and second supports 81, 82 sandwich the treatment device 1 and the base.

[0097] During implantation, an opening is made in the scleral tissue 913 on the eye 900. The implantation device 80 in a first state may be inserted into the opening such that the first and second supports 81, 82 are disposed within the opening. The implantation device 80 transforms to a second state (as shown in FIG. 18 ) in which the first and second supports 81, 82 separate, thereby releasing the treatment device 1. The implantation device 80 may be transformed from the first state to the second state manually or with the assistance of an instrument.

[0098] Once in the second state, the treatment device 1 can be moved from the first support 81 to the eye 900. In one embodiment, both the treatment device 1 and the support base can be moved to the eye, and once in the appropriate position, the support base can be removed, leaving only the treatment device in its final implantation location. In another embodiment, the treatment device 1 may be moved to the eye without the support base remaining on the first support 81. The movement of the treatment device 1 may be accomplished by forcing the treatment device 1 to move from the first support 81 by moving the implantation device 80 (such as by slight vibration).

[0099] 19-21, the embodiment further includes an implantation device 70, an implantation device 80 configured to implant the treatment device 1 into the eye 900. The following discussion is made with reference to treatment device 1, but also applies to treatment devices 1001, 2001, 3001, 4001.

[0100] According to this embodiment, the apparatus described herein further includes an injectable treatment device 71 that includes a support rod 72 for use in combination with the treatment device 1. Specifically, the treatment device 1 may be wound around the support rod 72, thereby forming an elongated cylindrical shape. In another embodiment, the injectable treatment device 71 does not include the support rod 72, and instead the treatment device 1 may be wound on itself.

[0101] The injection treatment device 71 may then be placed into an injector 74 configured such that the injection treatment device 71 is inserted into the eye 900 through a fluid passageway 75. In a non-limiting example, the injector 74 may be a syringe and the fluid passageway 75 may be formed by a needle.

[0102] During implantation, the fluid passageway 75 enters the bottom of the anterior chamber 988 and extends upward toward the sclera 913, allowing the treatment device 1 to be expelled from the implantation device 70 by a pump mechanism and delivered to the sclera 913. Upon delivery, the treatment device 1 may unfold from being wrapped around the support rod 72, thereby forming a fluid pathway from the anterior chamber to a location between the conjunctiva and the sclera 913 for excess aqueous humor to escape from the anterior chamber 988.

[0103] In an embodiment, an apparatus as described herein is shown in Figure 22. The apparatus 2200 comprises a plate structure 2202 having a first major exposed surface 2204 opposite a second major exposed surface (not shown), and a side surface 2206 extending therebetween. The plate structure 2202 includes an extension portion 2208 and a body portion 2210.

[0104] Generally, in FIG. 22, the extension 2208 includes two substantially parallel sides 2212, 2212' on either side of a substantially flat end surface 2214. This portion is referred to as the core or neck. In this embodiment, the junctions of the parallel sides 2212, 2212' and the substantially flat end surface 2214 are rounded. These rounded corners have a radius between about 0.2 mm and about 0.8 mm, between about 0.3 mm and about 0.8 mm, between about 0.4 mm and about 0.8 mm, between about 0.5 mm and about 0.8 mm, between about 0.6 mm and about 0.8 mm, between about 0.7 mm and about 0.8 mm, between about 0.4 mm and about 0.6 mm, or between about 0.3 mm and about 0.7 mm. However, in other embodiments, these junctions need not be rounded.

[0105] Similarly, the body portion 2210 includes two substantially parallel side surfaces 2216, 2216'. These parallel sides are located on either side of a substantially curved end surface 2218. In another embodiment, the substantially curved end surface 2218 can be a substantially flat end surface having a curved or non-curved junction.

[0106] The distance 2220 between the two substantially parallel sides 2212, 2212' is less than the distance 2222 between the two substantially parallel sides 2216, 2216'. In some embodiments, the distance 2220 is between about 1 mm and about 10 mm, between about 1 mm and about 9 mm, between about 1 mm and about 8 mm, between about 1 mm and about 6 mm, between about 2 mm and about 6 mm, between about 3 mm and about 6 mm, between about 3 mm and about 7 mm, between about 3 mm and about 8 mm, or between about 4 mm and about 6 mm. In some embodiments, the distance 2222 is between about 5 mm and about 10 mm, between about 5 mm and about 9 mm, between about 5 mm and about 8 mm, between about 5 mm and about 7 mm, or between about 5 mm and about 6 mm. In some embodiments, the substantially rounded end surface 2218 can have a radius of between about 1 mm and about 5 mm, between about 1 mm and about 4 mm, between about 1 mm and about 3 mm, or between about 1 mm and about 2 mm.

[0107] A distance 2224 between the substantially flat end surface 2214 and the interface of the extension 2208 and the body portion 2210 is between about 1 mm and about 5 mm, between about 1 mm and about 4 mm, between about 1 mm and about 3 mm, or between about 1 mm and about 2 mm. A distance 2226 between the interface of the extension 2208 and the body portion 2210 and the substantially rounded end surface 2218 is between about 5 mm and about 15 mm, between about 5 mm and about 14 mm, between about 5 mm and about 13 mm, between about 5 mm and about 12 mm, between about 5 mm and about 10 mm, between about 5 mm and about 9 mm, between about 6 mm and about 15 mm, between about 7 mm and about 15 mm, between about 8 mm and about 15 mm, between about 9 mm and about 15 mm, between about 10 mm and about 15 mm, or between about 9 mm and about 11 mm.

[0108] Additionally, the body portion 2210 includes two substantially rounded corners 2228, 2228' at the interface between the extension portion 2208 and the body portion 2210. However, the corners need not be rounded. In some embodiments, the substantially rounded corners 2228, 2228' have a radius between about 0.2 mm and about 1 mm, between about 0.3 mm and about 1 mm, between about 0.4 mm and about 1 mm, between about 0.5 mm and about 1 mm, between about 0.6 mm and about 1 mm, between about 0.7 mm and about 1 mm, between about 0.8 mm and about 1 mm, or between about 0.9 mm and about 1 mm. Additionally, the interface between the extension portion 2208 and the body portion 2210 is curved. However, the corners need not be curved. In some embodiments, the substantially rounded corners 2228, 2228' have a radius between about 0.2 mm and about 1 mm, between about 0.3 mm and about 1 mm, between about 0.4 mm and about 1 mm, between about 0.5 mm and about 1 mm, between about 0.6 mm and about 1 mm, between about 0.7 mm and about 1 mm, between about 0.8 mm and about 1 mm, or between about 0.9 mm and about 1 mm. The curvature can have a radius of between about 0.2 mm and about 0.8 mm, between about 0.3 mm and about 0.8 mm, between about 0.4 mm and about 0.8 mm, between about 0.5 mm and about 0.8 mm, between about 0.6 mm and about 0.8 mm, between about 0.7 mm and about 0.8 mm, between about 0.4 mm and about 0.6 mm, or between about 0.3 mm and about 0.7 mm.

[0109] In some embodiments, the device 2200 can include an indentation 2212. The indentation 2212 can be located anywhere around the perimeter of the side 2206 of either the extension portion 2208 or the body portion 2210.

[0110] In some embodiments, the device 2200 can include two or more indentations.

[0111] The indent(s) can have virtually any shape, including curved, linear, etc. In one embodiment, as shown in Figure 22, the indent 2212 is semicircular in shape. However, the indent 2212 could also be linear, such as a pyramid or point shape.

[0112] The indent(s) may be present to aid in proper orientation during implantation. In some embodiments, a single indent may be present to visually indicate to the implanter that the proper side of the device is facing up.

[0113] 23 shows a non-limiting embodiment of an inserter used to implant a device as described herein. The inserter 2300 comprises a body or housing 2302. The housing comprises a needle 2304 connected to its proximal end 2306. The needle 2304 has a sharpened proximal end 2308. The sharpened proximal end 2308 is used to pierce the ocular tissue during implantation of the device. In some embodiments, the needle 2304 is a low gauge needle, such as a 40 gauge, 39 gauge, 38 gauge, 37 gauge, 36 gauge, 35 gauge, 34 gauge, 33 gauge, 32 gauge, 31 gauge, 30 gauge, 29 gauge, 28 gauge, 27 gauge, 26 gauge, 25 gauge, 24 gauge, 23 gauge, 22 gauge, 21 gauge, or 20 gauge needle.

[0114] Included in the needle 2304 is a camera 2310. The camera 2310 is used to visualize the implantation process and can be a wired or wireless camera.

[0115] The device 2312 is housed within a compartment 2314 within the housing 2302 near its proximal end 2306. However, in another embodiment, the device 2312 may be housed within the needle 2304.

[0116] The slider 2316 may be located on the housing. Although the slider 2316 is shown at the top of the housing, it may be located virtually anywhere on the housing. The slider shape is shown for illustrative purposes, but may be virtually any shape that is capable of sliding. Furthermore, the slider need not be a mechanical slider. In some embodiments, the slider 2316 may be replaced by a button and an electronic slider mechanism (not shown).

[0117] The circuit board 2318 may include a memory and a processor(s) for executing a program stored in the memory. For example, if a button is used instead of a slider, the circuit board may perform that function. The circuit board 2318 is powered by a battery 2300. The battery 2318 may be any battery capable of powering the inserter 2300. Batteries include, but are not limited to, round cylindrical batteries such as AA, AAA, AAAA, C, and D, button cell batteries (lithium button), coin cell batteries, and non-round, 4.5V square, 9V square batteries, and the like. Additional button or coin cell batteries may be used. The battery may be removed if necessary. In some embodiments, the battery may be rechargeable.

[0118] Further associated with the circuit board 2318 is a wireless interface 2322. This interface may be any type of wireless interface, such as WiFi, Bluetooth, cellular, etc. This interface may transmit camera data, device data, etc.

[0119] In some embodiments, the inserter 2300 is disposable. In other embodiments, the inserter 2300 can be a multi-use device that can be cleaned and sterilized between uses.

[0120] During use, the device 2312 is loaded into the compartment 2314. In some embodiments, the device 2312 is preloaded into the inserter. When the slide is moved, the device is pushed out of the pointed proximal end 2308 of the needle 2304. In some embodiments, a winding device 2324 is located inside the compartment 2314 or the needle 2304 so that the device can be wound as it is pushed out. In another embodiment, the device is preloaded or wound when loaded into the preloaded inserter at the factory.

[0121] In some embodiments, the devices described herein can be used to enhance glaucoma treatment, even when other devices and methods are used. The devices can be inserted before or after the insertion of other ocular devices, such as stents. The devices can be used with other glaucoma stents, where the device acts as a tissue separator of the ocular tissue. This tissue separation can enhance the performance of the ocular stent for the treatment of glaucoma.

[0122] In some embodiments, the modern device can be used in place of Mitomycin C injections after eye surgery. In some embodiments, the device is inserted into the eye during surgery. In other embodiments, the device is inserted following surgery. The device helps to reduce intraocular pressure associated with surgery.

[0123] Example 1 Tests were conducted to evaluate the ability of the devices described herein to reduce intraocular pressure and protect the optic nerve. The devices are implanted to determine whether aqueous humor flows slowly and in a controlled manner through the mesh microchannels of the device into the subconjunctival space, forming a low, diffuse bleb.

[0124] [Table 1-1]

[0125] The test article is provided as a parylene-alumina composite fabricated by atomic layer deposition and chemical vapor deposition as described herein. The material was stored at room temperature and standard pressure.

[0126] Prior to the conduct of the study, each animal underwent an ophthalmologic examination (slit lamp examination and indirect ophthalmoscopy) by the study director or investigator. Ophthalmologic findings were scored using the modified McDonald-Shadduck scoring system. The acceptance criterion for conducting the study was a score of "0" for all variables.

[0127] Prior to being subjected to the study, each animal is acclimated to the intraocular pressure (IOP) measurement procedure once a day for 5-7 days prior to the start of the study to allow the animals to become accustomed to the IOP procedure and to determine a baseline IOP level. IOP measurements are performed using a Tonovet rebound tonometer during the same time of day (± 1 h) as the IOP measurements. At least three measurements are taken per eye per measurement event.

[0128] Animals are anesthetized with an intramuscular (IM) injection of ketamine hydrochloride (up to approximately 50 mg / kg), and xylazine (up to approximately 10 mg / kg), or dexmedetomidine (approximately 0.25 mg / kg). Glycopyrrolate (approximately 0.01 mg / kg, IM) may be administered simultaneously. Atipamezole hydrochloride (up to 1 mg / kg) may be used as an antagonist.

[0129] After surgical preparation of the eye, instill 1-2 drops of proparacaine hydrochloride local anesthetic (0.5%) into the animal's eye. Additional eye local anesthetic may be used during the procedure if needed.

[0130] On day 0, the test articles are implanted into the subconjunctival space of the right eye (OD).

[0131] The eyes are washed with betadine and rinsed with balanced salt solution (BSS). One to two drops of proparacaine hydrochloride local anesthetic (0.5%) are instilled into the animal's eye. Additional local anesthetic may be used during the procedure if necessary. The eye may be draped and a sterile wire speculum may be placed and the eyelids retracted.

[0132] A 60- to 90-degree fornix-based conjunctival incision is made at the supraorbital edge, with the first conjunctival incision made 2 mm posterior to the limbus. The pocket length should be 8 mm from the first incision.

[0133] An incision in the anterior chamber is made 1 mm from the limbus with a scalpel blade to create a scleral tunnel between the subconjunctival pocket and the anterior chamber.

[0134] Using forceps, gently grasp the specimen. Take care when manipulating the specimen as the material is very delicate and may stick to wet surfaces. Gently insert the graft into the subconjunctival pocket.

[0135] Insert the graft so that the round notch is positioned on the left, taking care to ensure correct orientation of the graft with the channel at the top. Gently guide the neck of the graft into the scleral tunnel, making sure it enters easily. Gently smooth the body of the graft, ensuring it sits flat in the proper position. Use BSS to moisten the tissue if necessary.

[0136] If there is anterior chamber collapse or low intraocular pressure, inflate the anterior chamber with BBS using a 27-gauge needle and 3 mL syringe. Inflating the AC with viscoelastic may make it more difficult to retain the neck of the graft in the AC, but viscoelastic can be used to facilitate smooth movement of the graft.

[0137] The implant is secured to the sclera with 10-0 nylon or polypropylene sutures by passing the sutures through each corner and the tail of the device.

[0138] The conjunctiva is closed with 10.0 nylon sutures or similar, avoiding the graft as much as possible, in a simple continuous pattern to create a watertight seal.

[0139] If the test article is difficult to visualize, a felt-tip surgical marker may be used to mark the bulbous body of the graft.

[0140] Following administration of the test article, the animals are allowed to recover rapidly and are monitored during the recovery period until the animals have fully recovered.

[0141] Administer a single injection of buprenorphine (0.02-0.05 mg / kg IM / SC) for analgesia prior to surgery. Additional buprenorphine doses are administered twice daily (approximately 12 hour intervals) on days 1-3 following test article administration. Alternatively, sustained release buprenorphine (approximately 0.1 mg / kg SC) may be administered on day 1.

[0142] On day 0 after completion of the implantation procedure, one drop of 0.3% ofloxacin and one drop of 1% prednisolone acetate will be instilled into the eye, four times daily on days 1-7 after test article administration.

[0143] Ophthalmic clinical examinations (slit lamp examination only) will be performed on both eyes (OU) of all test animals at baseline (before test article administration), promptly at day 0 after test article implantation, and again on days 1, 3, 7 (±1), 14 (±1), and 21 (±3). If the study is extended further, further examinations will be performed on days 35 (±3), 49 (±3), 63 (±3), 77 (±3), and 91 (±3).

[0144] Intraocular pressure (IOP) will be performed in both eyes (OU) of all study animals at baseline (before test article administration), immediately after test article implantation on day 0, and again on days 1, 3, 7 (±1), 14 (±1), and 21 (±3). If the study is extended further, further IOP measurements will be taken on days 35 (±3), 49 (±3), 63 (±3), 77 (±3), and 91 (±3).

[0145] IOP measurements will be performed by the same technician at the same time each day (± 1 hour) using a Tonovet rebound tonometer. At least three measurements will be taken per eye for each measurement event.

[0146] Slit-lamp photographs of both eyes (OU) of all test animals were taken at baseline (before test article administration), immediately after test article implantation on day 0, and again on days 1, 7 (±1), and 21 (±3).

[0147] Fluorescein examination was performed on all right eyes (OD) on day 21 (±3) to assess test article patency and flow of aqueous humor from the anterior chamber into the subconjunctival space.

[0148] To avoid excessive intraocular pressure (IOP), a small (approximately 30 gauge) needle is inserted into the anterior chamber to allow aqueous humor to drain from the anterior chamber. A second small needle is introduced into the anterior chamber and 0.5 mL of 0.01% sodium fluorescein solution in balanced salt solution (BSS) is slowly injected into the anterior chamber over a period of 20 minutes. IOP is monitored throughout the procedure to ensure it does not exceed a safe level.

[0149] Post-injection findings include a note on the flow (or lack thereof) of test article and fluorescein into the subconjunctival space and are recorded with the raw data.

[0150] Digital photographs of the eye may be taken with a slit lamp or DSLR camera, if desired, to document findings. Additional photographs may be taken using fluorescein and / or cobalt blue filters.

[0151] As shown in Figure 24, intraocular pressure in treated eyes decreased by an average of 25% from baseline at day 7 and remained lower than baseline and controls. The baseline score is the average of intraocular pressure over the 5 days prior to device implantation surgery.

[0152] Blebs were present in all grafts.

[0153] In addition, he had low scores for all ophthalmologic findings according to the McDonald-Shadduck scoring system.

[0154] Example 2 The results of the Example 1 study are compared to results using the InnFocus SIBS device. As shown in Figure 25, the test eyes using the device described herein have lower intraocular pressure than the controls for 22 days post-surgery.

[0155] Conversely, no statistically significant difference in intraocular pressure reduction was found between SIBS-implanted and control eyes at 7 days postoperatively.

[0156] Example 3 The test group of Example 1 was used for further testing. On day 22, 0.5 mL of 0.01% sodium fluorescein was injected into the anterior chamber over 20 minutes. The fluorescein dye flowed into the subconjunctival bleb formed by the device, indicating patency of the channel. Furthermore, a large diffuse filter area was maintained beyond the device surface area and beyond the incision area, thereby indicating flow from the anterior chamber.

[0157] Example 4 A single or multi-layer plate(s) is implanted in the subconjunctival space from within and with a minimally invasive approach using an insertion device such as, but not limited to, a gel stent. A small portion of the device (a few mm in length) is located in the anterior chamber, allowing aqueous humor to flow along it by capillary action into the subconjunctival space (between Tenon's capsule and the sclera).

[0158] Fluid flows through microchannels within the plate and above / below the plate. The orientation of the microchannels can be facing the conjunctiva or sclera to maximize flow.

[0159] The device is preloaded into a capsule or cartridge that fits into the insertion device, which can be easily placed into the correct position on the eye and then withdrawn from the eye leaving the device behind.

[0160] The inserter has a tapered, flat / rectangular blade that starts at the cornea in the inferonasal part of the eye and moves upward to push aside the tissue in the superior temporal region to make a minimally invasive incision. The blade can be tapered or open to prevent tissue from clogging the opening or plate buildup. The tip of the inserter, or the body of the inserter blade, has a protrusion on it to prevent it from cutting too deeply into the tissue. The protrusion further aids in positioning the blade and in making the incision with the blade.

[0161] Once the blade has opened an outflow passage from the anterior chamber to the subconjunctival space, the insertion device, either through the blade or through some other device, pushes the device into the open space, placing the device so that most of the plate is in tissue but extends a few millimeters into the anterior chamber. The insertion device is then removed and the surgeon closes the remaining opening in the eye.

[0162] Example 5 This example describes the use of a device to reduce intraocular pressure and the tolerability of the device when implanted subconjunctivally in New Zealand White rabbits.

[0163] Surgical method: At the start of the study, three virgin New Zealand White rabbits (one male and two females), approximately 5 months of age and weighing 2.8-3.3 kilograms, male and female, will be assigned to treatment groups as shown in Table 1-2 below.

[0164] [Table 1-2]

[0165] To implant the treatment device, each rabbit was anesthetized subcutaneously with a combination of ketamine (40 mg / kg) and xylazine (4 mg / kg). Anesthetics were supplemented as necessary. All drug use was recorded with live data. At this time, a few drops of 1% proparacaine (local anesthetic) were also placed in both eyes. After anesthesia, the rabbit was placed in a lateral position and the area around the eye was prepared with a swap stick containing 10% providone-iodine. The eye was rinsed with 0.9% sterile saline and a few more drops of proparacaine were placed. A sterile drape was placed over the rabbit to expose the eye. Sterile instruments (steam autoclaved before the first procedure and then, between animals, chemically sterilized with chlorhexidine solution and rinsed with sterile water / saline). Sterile gloves were worn.

[0166] The eyelids are held open for surgery, either manually or using a lid retractor. The eye is rotated medially using Colibri forceps and a small incision is made in the conjunctiva lateral to the iris. A subconjunctival pocket is created ventrally and the treatment device is placed within. Upon placement, the eye is rotated back to its normal position and placement of the treatment device is observed to ensure it is properly placed in the subconjunctival pocket. The rabbit is rotated to the other side and a sham procedure is performed on the contralateral eye in the same manner, without implantation of the treatment device or other materials. Sterile ophthalmic ointment is applied to both eyes for the recovery period.

[0167] Observations and Measurements: On day 1, the treatment device is implanted into the subject via a conjunctival incision between the sclera and conjunctiva. Mortality and clinical findings are assessed daily. Ocular irritation scores are recorded daily before dosing on day 1, and on days 2-5, 12, and 19. Body weights are recorded weekly. Food consumption is recorded daily. All animals are sacrificed on day 21. Eyes with optic nerves of all animals are collected at necropsy and evaluated microscopically.

[0168] Histological analysis: On day 21, sacrifice the animals by intravenous injection of an excess amount of barbiturates. Autopsy all animals. Collect the eyes with the optic nerve and immediately fix them in Davidson's fixative for 24-48 h. After dehydrating the nerve specimens in increasing concentrations of ethanol (30-100%), section the nerves with sharp razor blades. Embed the sections in paraffin in order of size and cut into 3 mm thick sections. Stain the sections with hematoxylin and eosin. Cut two sections (half of the eyeball) in the pupil-optic disc direction from each eye and section them with a microtome at two levels per paraffin block, resulting in four slides per eye for microphonic examination.

[0169] (Results and Discussion) The treatment device is administered once on day 1 to one male and two female New Zealand White rabbits via a conjunctival incision between the sclera and conjunctiva.

[0170] Mortality / Morbidity: There were no early deaths during the study. All animals survived to day 21 when they were scheduled for sacrifice.

[0171] Clinical findings: On day 1, mild to moderate behavioral depression was noted post-surgery, with all animals having their eyes closed or partially closed 2-4 hours after dosing. These findings are considered unrelated to the test substance and are secondary to anesthesia and surgery. All animals appear normal on days 2-21 of the study.

[0172] Ocular Observations: Prior to dosing on Day 1, all animals had an ocular Draize score of 0 in their eyes (left and right). Minimal Draize scores were recorded overall on days 2 and 3 of the study. Scores are recorded in both the left and right eyes (drainage device implantation and sham procedure, respectively). By day 4, no ocular scores are noted. Table 2 below summarizes the overall ocular Draize scores recorded during the study.

[0173] [Table 2]

[0174] Body Weight: There were no apparent test substance-related effects on body weight or weight gain.

[0175] Food consumption: No test substance related effects were observed on food consumption. Animals essentially ate all of their food on all days.

[0176] (Postmortem observations) Gross necropsy findings: No gross necropsy findings were noted on the 21st day, the day of planned sacrifice.

[0177] Histopathology: The therapeutic device is not visible microscopically in any animal. Focal scleral changes are noted near the limbus of some eyes, consisting of conjunctival and superficial collagen fibers that bulge and separate from the deeper collagen fibers of the sclera, forming cavities. Apart from collagen fragmentation, no significant tissue reaction is noted. Defects of minimal (grade 1) severity are noted in two control eyes (right eyes), while defects of mild (grade 2) to moderate (grade 3) severity are evident in two of the three treated eyes (left eyes), raising the suspicion that the tissue defects in the eyes that received the therapeutic device represent, at least in part, implantation sites where the implant was fragmented or washed away during processing. Conjunctival hyperplasia, lymphoplasmocytic infiltration, and / or minimally severe fibrosis are noted near the limbus of the right and left eyes of three animals. These lesions could be explained as spontaneous background findings and / or related to the surgical manipulation.

[0178] In summary, there are no study-related clinical findings, no effect on body weight or weight gain, or on food consumption. After surgery, there are minimal overall Draize scores and all eyes appear normal by day 4. At day 21, when sacrifice is scheduled, there are no gross necropsy findings. After tissue processing, the therapeutic device is not visible and no tissue reaction is noted at the implantation site. In conclusion, the therapeutic device is well tolerated when implanted subconjunctivally in New Zealand White rabbits.

[0179] It will be understood that the above is merely an illustration of the tolerability of the therapeutic device when implanted in the eye, but is merely an illustration of the principles of the present disclosure, and that various modifications may be made by those skilled in the art without departing from the scope and spirit of the present disclosure.

[0180] Example 6 Fibroblasts are cultured on flat plastic cell culture dishes, patterned silicon wafers coated with Parylene-C, and on the surfaces of cell culture dishes coated with Parylene-C. Samples are placed at 37°C for 24 hours to allow attachment to the surfaces. Cell culture medium is added and allowed to grow for an additional 48 hours. Fibroblasts attach and grow normally on the flat plastic dishes, but on the Parylene-coated samples they float in large cell clumps and could not be counted. These results indicate that the hydrophobicity of Parylene prevents fibrotic cell attachment. Furthermore, the results indicate that Parylene can prevent tissue attachment.

[0181] Example 7 The devices described herein, coated with Parylene-C, are implanted into the subconjunctival space of NZW rabbits and communicate with the anterior chamber. Implants and blebs are sectioned, fixed, and examined histologically after 83 days.

[0182] The thickness of the fibrotic blebs in three rabbits was measured, and the results are shown in Table 3.

[0183] [Table 3]

[0184] Fibrosis thickness is the average of four measurements: rostral, scleral, posterior and conjunctival. Fibrosis thickness on the scleral and conjunctival sides is the average of four equally spaced measurements on each side of the graft.

[0185] The results in Table 4 are also compared to implantation of an Ahmed Glaucoma valve in the same space, with and without amniotic membrane. The device of the present invention shows significantly lower fibrous capsule thickness than the AGV.

[0186] [Table 4]

[0187] These results indicate that hydrophilic coatings such as parylene and / or patterned surfaces such as those of the described devices reduce fibrotic growth and scarring.

[0188] While the present technology has been described in detail for purposes of illustration based on what are presently considered to be the most practical and preferred embodiments, it should be understood that such detail is for purposes of illustration only, and that the present technology is not limited to the disclosed embodiments, but on the contrary, is intended to cover modifications and equivalent arrangements within the spirit and scope of the appended claims. For example, it should be understood that the present technology contemplates that, to the extent possible, one or more features of any embodiment can be combined with one or more features of any other embodiment.

[0189] Unless otherwise indicated, all numbers expressing quantities of ingredients, molecular weights, reaction conditions, and the like used in the specification and claims should be understood in all instances to be modified by the term "about". Thus, unless indicated to the contrary, the numerical parameters set forth in the specification and appended claims are approximations that may vary depending on the desired properties sought to be obtained by the present invention. At the very least, no attempt is made to limit the scope of the claims to equivalents, and each numerical parameter should at least be construed in light of the number of reported significant digits and by applying ordinary rounding techniques. Notwithstanding that the numerical ranges and parameters setting forth the broad scope of the invention are approximations, the numerical values ​​set forth in the specific examples are reported as precisely as possible. However, any numerical value inherently contains certain errors necessarily resulting from the standard deviation found in their respective testing measurements.

[0190] The terms "a", "an", "the", and similar references used in the context of describing the present invention (particularly in the context of the claims below) should be construed to cover both the singular and the plural, unless otherwise indicated or clearly contradicted by context. The recitation of ranges of values ​​herein is merely intended to serve as a shorthand method for individually referring to each individual value falling within the range. Unless otherwise indicated herein, each individual value is incorporated herein as if it were individually recited herein. All methods described herein can be performed in any suitable order, unless otherwise indicated herein or clearly contradicted by context. The use of any and all examples or exemplary language (e.g., "such as") provided herein is intended to better clarify the invention and does not limit the scope of the invention as otherwise claimed. Nothing in this specification should be construed as indicating any non-claimed element essential to the practice of the invention.

[0191] Groupings of alternative elements or embodiments of the invention disclosed herein are not to be construed as limitations. The members of each group may be referenced and claimed individually or in any combination with other members of the group or with other elements found herein. It is anticipated that for reasons of convenience or patentability, one or more members of a group may be included in, or deleted from, a group. When such inclusion or deletion occurs, the specification is deemed to include the modified group and satisfies all recitations of the Markush group as used in the appended claims.

[0192] Several embodiments of the invention are described herein, including the best mode known to the inventors for carrying out the invention. Of course, variations of these described embodiments will be apparent to those of skill in the art upon reading the foregoing description. The inventors expect those of skill in the art to make suitable use of such variations, and the inventors intend to practice the invention otherwise than as specifically described herein. Accordingly, this invention includes all modifications and equivalents of the subject matter recited in the claims appended hereto as permitted by applicable law. Moreover, combinations of the above-described elements in all possible variations are included herein unless otherwise indicated herein or clearly contradicted by context.

[0193] Some of the specific embodiments disclosed herein may be further limited in the claims by the use of the phrases "consisting of" or "consisting essentially of." When used in a claim, whether as filed or added by amendment, the transitional phrase "consisting of" excludes any element, step, or ingredient not specified in the claim. The transitional phrase "consisting essentially of" limits the scope of the claim to the particular materials or steps, and those that do not materially affect the basic and novel characteristic(s). The embodiments of the invention so claimed are essentially or explicitly described and enabled herein.

[0194] Finally, it should be understood that the embodiments of the invention disclosed herein are illustrative of the principles of the invention. Other modifications that may be employed are within the scope of the invention. Thus, by way of example, and not of limitation, alternative configurations of the invention may be utilized in accordance with the teachings herein. Thus, the invention is not limited to that precisely as shown and described.

[0195] (Additional Note) (Appendix 1) a plate having a first surface opposite a second surface, the first surface including a series of fluid channels; a first coating on the first surface; and a second coating on the second surface; and Equipped with A device for reducing intraocular pressure.

[0196] (Appendix 2) 2. The apparatus of claim 1, wherein the plate has a thickness of about 50 nm to about 800 nm.

[0197] (Appendix 3) 2. The apparatus of claim 1, wherein the plate is formed from a ceramic material.

[0198] (Appendix 4) 4. The apparatus of claim 3, wherein the ceramic material is selected from the group consisting of alumina, silicon nitride, silica, hafnium oxide, titanium nitride, and titanium carbide.

[0199] (Appendix 5) 2. The apparatus of claim 1, wherein the first coating has a thickness of about 0.1 μm to about 1 μm.

[0200] (Appendix 6) 2. The apparatus of claim 1, wherein the first coating is a parylene polymer.

[0201] (Appendix 7) 7. The apparatus of claim 6, wherein the parylene polymer is Parylene C, Parylene D, Parylene N, a derivative thereof, or a combination thereof.

[0202] (Appendix 8) 2. The device of claim 1, wherein the first coating is a polymeric material selected from rubber, synthetic rubber, silicone polymer, parylene, thermoplastic, thermoset, polyolefin, polyisobutylene, acrylic polymer, ethylene-co-vinyl acetate, polybutyl methacrylate, vinyl halide polymer, polyvinyl ether, polyvinylidene halides, polyacrylonitrile, polyvinyl ketone, polyvinyl aromatic, polyvinyl ester, acrylonitrile-styrene copolymer, ABS resin, ethylene-vinyl acetate copolymer, polyamide, alkyd resin, polycarbonate, polyoxymethylene, polyimide, polyether, epoxy resin, polyurethane, rayon, cellulose, cellulose acetate, cellulose butyrate, cellulose acetate butyrate, cellophane, cellulose nitrate, cellulose propionate, cellulose ether, carboxymethyl cellulose, polytetrafluoroethylene, poly(ether-ether-ketone), polylactides such as PLA, PLGA, PLLA, derivatives thereof, or combinations thereof.

[0203] (Appendix 9) 2. The apparatus of claim 1, wherein the second coating has a thickness of about 0.1 μm to about 1 μm.

[0204] (Appendix 10) 2. The apparatus of claim 1, wherein the second coating is aluminum oxide or a parylene polymer.

[0205] (Appendix 11) 2. The device of claim 1, wherein the second coating comprises aluminum oxide, rubber, synthetic rubber, a silicone polymer, parylene, a thermoplastic, a thermoset, a polyolefin, polyisobutylene, an acrylic polymer, ethylene-co-vinyl acetate, polybutyl methacrylate, a vinyl halide polymer, a polyvinyl ether, a polyvinylidene halide, a polyacrylonitrile, a polyvinyl ketone, a polyvinyl aromatic, a polyvinyl ester, an acrylonitrile-styrene copolymer, an ABS resin, an ethylene-vinyl acetate copolymer, a polyamide, an alkyd resin, a polycarbonate, a polyoxymethylene, a polyimide, a polyether, an epoxy resin, a polyurethane, a rayon, a cellulose, a cellulose acetate, a cellulose butyrate, a cellulose acetate butyrate, a cellophane, a cellulose nitrate, a cellulose propionate, a cellulose ether, a carboxymethyl cellulose, a polytetrafluoroethylene, a poly(ether-ether-ketone), a polylactide such as PLA, PLGA, PLLA, a derivative thereof, or a combination thereof.

[0206] (Appendix 12) 2. The device of claim 1, wherein the series of fluid channels includes a plurality of open-ended channels that are interconnected to form an intersecting network of fluid pathways.

[0207] (Appendix 13) 2. The device of claim 1, further comprising a drug.

[0208] (Appendix 14) inserting into an eye with high intraocular pressure a device comprising a plate having a first surface opposite a second surface, the first surface including a series of fluid channels, a first coating on the first surface, and a second coating on the second surface; Treating high intraocular pressure; 4. A method for reducing intraocular pressure comprising:

[0209] (Appendix 15) 15. The method of claim 14, further comprising fixing the device to the eye.

[0210] (Appendix 16) 16. The method of claim 15, wherein the fixation is to the sclera.

[0211] (Appendix 17) 15. The method of claim 14, wherein at least a portion of the first surface of the plate structure faces the conjunctiva of the eye and at least a portion of the second surface faces the sclera of the eye.

[0212] (Appendix 18) 18. The method of claim 17, wherein the device forms a fluid passageway providing fluid communication between the anterior chamber of the eye and a position of the device.

[0213] (Appendix 19) 19. The method of claim 18, wherein the fluid passage comprises the series of fluid channels.

[0214] (Appendix 20) 15. The method of claim 14, wherein the treatment of ocular hypertension is treatment of glaucoma.

Claims

1. A plate having a first end face and a second end face, with a first face opposite the second face, the first face including a series of fluid channels configured as an intersecting lattice pattern of open ends extending from the first end face to the second end face, a width of the first end face being narrower than a width of the second end face to enable insertion of the first end face into the anterior chamber of a patient's eye, the second face including a plurality of open cells formed by the series of fluid channels; a first coating on the first surface that conforms to a topography of the series of fluid channels; a second coating on the second surface; and Equipped with A device for reducing intraocular pressure.

2. The device of claim 1, wherein the intersecting lattice pattern includes a hexagonal lattice pattern, and each of the plurality of open cells has a hexagonal shape.

3. The device described in claim 1, wherein the plate has a thickness of about 50 nm to about 800 nm.

4. The apparatus of claim 1, wherein the plate is formed from a ceramic material.

5. The apparatus of claim 4, wherein the ceramic material is selected from the group consisting of alumina, silicon nitride, silica, hafnium oxide, titanium nitride, and titanium carbide.

6. The device described in claim 1, wherein the first coating is a poly(paraxylylene) based polymer.

7. The device of claim 6, wherein the poly(paraxylylene)-based polymer is poly(2-chloroparaxylylene), poly(2,5-dichloroparaxylylene), poly(paraxylylene), or a combination thereof.

8. The apparatus of claim 1, wherein the first coating is a polymeric material selected from rubber, synthetic rubber, silicone polymer, poly(paraxylylene) based polymer, thermoplastic resin, thermoset resin, polyolefin, polyisobutylene, acrylic polymer, ethylene-co-vinyl acetate, polybutyl methacrylate, vinyl halide polymer, polyvinyl ether, polyvinylidene halides, polyacrylonitrile, polyvinyl ketone, polyvinyl aromatic resin, polyvinyl ester, acrylonitrile-styrene copolymer, ABS resin, ethylene-vinyl acetate copolymer, polyamide, alkyd resin, polycarbonate, polyoxymethylene, polyimide, polyether, epoxy resin, polyurethane, rayon, cellulose, cellulose acetate, cellulose butyrate, cellulose acetate butyrate, cellophane, cellulose nitrate, cellulose propionate, cellulose ether, carboxymethyl cellulose, polytetrafluoroethylene, poly(ether-ether-ketone), polylactide, or combinations thereof.

9. The device described in claim 1, wherein the second coating has a thickness of about 0.1 μm to about 1 μm.

10. The device of claim 1, wherein the second coating is aluminum oxide or a poly(paraxylylene) based polymer.

11. The apparatus of claim 1, wherein the second coating comprises aluminum oxide, rubber, synthetic rubber, a silicone polymer, a poly(paraxylylene) based polymer, a thermoplastic resin, a thermoset resin, a polyolefin, a polyisobutylene, an acrylic polymer, an ethylene-co-vinyl acetate, a polybutyl methacrylate, a vinyl halide polymer, a polyvinyl ether, a polyvinylidene halide, a polyacrylonitrile, a polyvinyl ketone, a polyvinyl aromatic resin, a polyvinyl ester, an acrylonitrile-styrene copolymer, an ABS resin, an ethylene-vinyl acetate copolymer, a polyamide, an alkyd resin, a polycarbonate, a polyoxymethylene, a polyimide, a polyether, an epoxy resin, a polyurethane, a rayon, a cellulose, a cellulose acetate, a cellulose butyrate, a cellulose acetate butyrate, a cellophane, a cellulose nitrate, a cellulose propionate, a cellulose ether, a carboxymethyl cellulose, a polytetrafluoroethylene, a poly(ether-ether-ketone), a polylactide, or a combination thereof.

12. The device of claim 1, further comprising a drug.

13. The device described in claim 1, configured for placement within an eye with high intraocular pressure and used to treat high intraocular pressure.

14. The device described in claim 13, wherein the device is fixed to the eye.

15. The device described in claim 14, wherein the fixation is to the sclera of the eye.

16. The device described in claim 15, wherein at least a portion of the first surface of the plate faces the conjunctiva of the eye and at least a portion of the second surface faces the sclera of the eye.

17. The device described in claim 13, wherein the treatment for high intraocular pressure is treatment for glaucoma.

18. The device of claim 1, wherein the device forms a fluid passageway that provides fluid communication from the anterior chamber of the eye to the second end surface of the plate.

19. The apparatus of claim 1, wherein at least one of the first coating and the second coating has a thickness that is one to three orders of magnitude thicker than the thickness of the plate.

20. The device described in claim 1, wherein the first coating is configured to be hydrophilic and the second coating is configured to be hydrophobic.

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